[Title 21 CFR ]
[Code of Federal Regulations (annual edition) - April 1, 2021 Edition]
[From the U.S. Government Publishing Office]



[[Page i]]

          

                                        Title 21

                                      Food and Drugs
                                 ________________________

                                    Parts 500 to 599

                              Revised as of April 1, 2021

          Containing a codification of documents of general 
          applicability and future effect

          As of April 1, 2021
                    Published by the Office of the Federal Register 
                    National Archives and Records Administration as a 
                    Special Edition of the Federal Register

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                            Table of Contents



                                                                    Page
  Explanation.................................................       v

  Title 21:
          Chapter I--Food and Drug Administration, Department 
          of Health and Human Services (Continued)                   3
  Finding Aids:
      Table of CFR Titles and Chapters........................     617
      Alphabetical List of Agencies Appearing in the CFR......     637
      List of CFR Sections Affected...........................     647

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                     ----------------------------

                     Cite this Code: CFR
                     To cite the regulations in 
                       this volume use title, 
                       part and section number. 
                       Thus, 21 CFR 500.23 refers 
                       to title 21, part 500, 
                       section 23.

                     ----------------------------

[[Page v]]



                               EXPLANATION

    The Code of Federal Regulations is a codification of the general and 
permanent rules published in the Federal Register by the Executive 
departments and agencies of the Federal Government. The Code is divided 
into 50 titles which represent broad areas subject to Federal 
regulation. Each title is divided into chapters which usually bear the 
name of the issuing agency. Each chapter is further subdivided into 
parts covering specific regulatory areas.
    Each volume of the Code is revised at least once each calendar year 
and issued on a quarterly basis approximately as follows:

Title 1 through Title 16.................................as of January 1
Title 17 through Title 27..................................as of April 1
Title 28 through Title 41...................................as of July 1
Title 42 through Title 50................................as of October 1

    The appropriate revision date is printed on the cover of each 
volume.

LEGAL STATUS

    The contents of the Federal Register are required to be judicially 
noticed (44 U.S.C. 1507). The Code of Federal Regulations is prima facie 
evidence of the text of the original documents (44 U.S.C. 1510).

HOW TO USE THE CODE OF FEDERAL REGULATIONS

    The Code of Federal Regulations is kept up to date by the individual 
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    To determine whether a Code volume has been amended since its 
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EFFECTIVE AND EXPIRATION DATES

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OMB CONTROL NUMBERS

    The Paperwork Reduction Act of 1980 (Pub. L. 96-511) requires 
Federal agencies to display an OMB control number with their information 
collection request.

[[Page vi]]

Many agencies have begun publishing numerous OMB control numbers as 
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PAST PROVISIONS OF THE CODE

    Provisions of the Code that are no longer in force and effect as of 
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for 1949-1963, 1964-1972, 1973-1985, and 1986-2000.

``[RESERVED]'' TERMINOLOGY

    The term ``[Reserved]'' is used as a place holder within the Code of 
Federal Regulations. An agency may add regulatory information at a 
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INCORPORATION BY REFERENCE

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This material, like any other properly issued regulation, has the force 
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alphabetical list of agencies publishing in the CFR are also included in 
this volume.

[[Page vii]]

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    Oliver A. Potts,
    Director,
    Office of the Federal Register.
    April 1, 2021.







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                               THIS TITLE

    Title 21--Food and Drugs is composed of nine volumes. The parts in 
these volumes are arranged in the following order: Parts 1-99, 100-169, 
170-199, 200-299, 300-499, 500-599, 600-799, 800-1299 and 1300 to end. 
The first eight volumes, containing parts 1-1299, comprise Chapter I--
Food and Drug Administration, Department of Health and Human Services. 
The ninth volume, containing part 1300 to end, includes Chapter II--Drug 
Enforcement Administration, Department of Justice, and Chapter III--
Office of National Drug Control Policy. The contents of these volumes 
represent all current regulations codified under this title of the CFR 
as of April 1, 2021.

    For this volume, Ann Worley was Chief Editor. The Code of Federal 
Regulations publication program is under the direction of John Hyrum 
Martinez, assisted by Stephen J. Frattini.

[[Page 1]]



                        TITLE 21--FOOD AND DRUGS




                  (This book contains parts 500 to 599)

  --------------------------------------------------------------------
                                                                    Part

chapter i--Food and Drug Administration, Department of 
  Health and Human Services (Continued).....................         500

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CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)




  --------------------------------------------------------------------


  Editorial Note: Nomenclature changes to chapter I appear at 69 FR 
13717, Mar. 24, 2004, and 69 FR 18803, Apr. 9, 2004.

         SUBCHAPTER E--ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS
Part                                                                Page
500             General.....................................           5
501             Animal food labeling........................          15
502             Common or usual names for nonstandardized 
                    animal foods............................          32
507             Current good manufacturing practice, hazard 
                    analysis, and risk-based preventive 
                    controls for food for animals...........          34
509             Unavoidable contaminants in animal food and 
                    food-packaging material.................          68
510             New animal drugs............................          72
511             New animal drugs for investigational use....          82
514             New animal drug applications................          87
515             Medicated feed mill license.................         124
516             New animal drugs for minor use and minor 
                    species.................................         128
520             Oral dosage form new animal drugs...........         153
522             Implantation or injectable dosage form new 
                    animal drugs............................         268
524             Ophthalmic and topical dosage form new 
                    animal drugs............................         351
526             Intramammary dosage form new animal drugs...         379
528             New animal drugs in genetically engineered 
                    animals.................................         384
529             Certain other dosage form new animal drugs..         385
530             Extralabel drug use in animals..............         393
556             Tolerances for residues of new animal drugs 
                    in food.................................         399
558             New animal drugs for use in animal feeds....         414
564             [Reserved]

570             Food additives..............................         537
571             Food additive petitions.....................         549

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573             Food additives permitted in feed and 
                    drinking water of animals...............         554
579             Irradiation in the production, processing, 
                    and handling of animal feed and pet food         580
582             Substances generally recognized as safe.....         581
584             Food substances affirmed as generally 
                    recognized as safe in feed and drinking 
                    water of animals........................         605
589             Substances prohibited from use in animal 
                    food or feed............................         607
590-599         [Reserved]

[[Page 5]]



         SUBCHAPTER E_ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS





PART 500_GENERAL--Table of Contents



Subpart A [Reserved]

         Subpart B_Specific Administrative Rulings and Decisions

Sec.
500.23 Thermally processed low-acid foods packaged in hermetically 
          sealed containers.
500.24 Emergency permit control.
500.25 Anthelmintic drugs for use in animals.
500.26 Timed-release dosage form drugs.
500.27 Methylene blue-containing drugs for use in animals.
500.29 Gentian violet for use in animal feed.
500.30 Gentian violet for animal drug use.
500.45 Use of polychlorinated biphenyls (PCB's) in the production, 
          handling, and storage of animal feed.
500.46 Hexachlorophene in animal drugs.
500.50 Propylene glycol in or on cat food.

               Subpart C_Animal Drug Labeling Requirements

500.51 Labeling of animal drugs; misbranding.
500.52 Use of terms such as ``tonic'', ``tone'', ``toner'', or 
          ``conditioner'' in the labeling of preparations intended for 
          use in or on animals.
500.55 Exemption from certain drug-labeling requirements.

            Subpart D_Requirements for Specific Animal Drugs

500.65 Epinephrine injection 1:1,000 in 10-milliliter containers for 
          emergency treatment of anaphylactoid shock in cattle, horses, 
          sheep, and swine.

 Subpart E_Regulation of Carcinogenic Compounds Used in Food-Producing 
                                 Animals

500.80 Scope of this subpart.
500.82 Definitions.
500.84 Conditions for approval of the sponsored compound.
500.86 Marker residue and target tissue.
500.88 Regulatory method.
500.90 Waiver of requirements.
500.92 Implementation.

 Subpart F_Methods for Detection of Residues of Carcinogenic Compounds 
                     Used in Food-Producing Animals

500.1410 N-methyl-2-pyrrolidone.

    Authority: 21 U.S.C. 321, 331, 342, 343, 348, 351, 352, 353, 360b, 
371, 379e.

    Source: 40 FR 13802, Mar. 27, 1975, unless otherwise noted.

Subpart A [Reserved]



         Subpart B_Specific Administrative Rulings and Decisions



Sec. 500.23  Thermally processed low-acid foods packaged in 
hermetically sealed containers.

    Except as provided in Sec. 507.5(b) of this chapter, the provisions 
of parts 507 and 113 of this chapter apply to the manufacturing, 
processing, or packing of low-acid foods in hermetically sealed 
containers, and intended for use as food for animals.

[80 FR 56337, Sept. 17, 2015]



Sec. 500.24  Emergency permit control.

    The provisions of part 108 of this chapter shall apply to the 
issuance of emergency control permits for the manufacturer or packer of 
thermally processed low-acid foods packaged in hermetically sealed 
containers, and intended for use as food for animals.

[61 FR 37681, July 19, 1996]



Sec. 500.25  Anthelmintic drugs for use in animals.

    (a) The Commissioner of Food and Drugs has determined that, in order 
to assure that anthelmintic drugs, including animal feeds bearing or 
containing such drugs, which do not carry the prescription statement are 
labeled to provide adequate directions for their effective use, labeling 
of these anthelmintic drugs shall bear, in addition to other required 
information, a statement that a veterinarian should be consulted for

[[Page 6]]

assistance in the diagnosis, treatment, and control of parasitism.
    (b) The label and any labeling furnishing or purporting to furnish 
directions for use, shall bear conspicuously the following statement: 
``Consult your veterinarian for assistance in the diagnosis, treatment, 
and control of parasitism.''
    (c) For drugs covered by approved new animal drug applications, the 
labeling revisions required for compliance with this section may be 
placed into effect without prior approval, as provided for in Sec. 
514.8(c)(3) of this chapter. For drugs listed in the index, the labeling 
revisions required for compliance with this section may be placed into 
effect without prior granting of a request for a modification, as 
provided for in Sec. 516.161(b)(1) of this chapter.
    (d) Labeling revisions required for compliance with this section 
shall be placed into effect by February 25, 1975, following which, any 
such drugs that are introduced into interstate commerce and not in 
compliance with this section will be subject to regulatory proceedings.

[40 FR 13802, Mar. 27, 1975, as amended at 71 FR 74782, Dec. 13, 2006; 
72 FR 69120, Dec. 6, 2007]



Sec. 500.26  Timed-release dosage form drugs.

    (a) Drugs are being offered in dosage forms that are designed to 
release the active ingredients over a prolonged period of time. There is 
a possibility of unsafe overdosage or ineffective dosage if such 
products are improperly made and the active ingredients are released at 
one time, over too short or too long a period of time, or not released 
at all. Drugs marketed in this form, which are referred to by such terms 
as timed-release, controlled-release, prolonged-release, sustained-
release, or delayed-release drugs, are regarded as new animal drugs 
within the meaning of section 201(v) of the Federal Food, Drug, and 
Cosmetic Act.
    (b) Timed-release dosage form animal drugs that are introduced into 
interstate commerce are deemed to be adulterated within the meaning of 
section 501(a)(5) of the act and subject to regulatory action, unless 
such animal drug is the subject of an approved new animal drug 
application, or listed in the index, as required by paragraph (a) of 
this section.
    (c) The fact that the labeling of this kind of drug may claim 
delayed, prolonged, controlled, or sustained-release of all or only some 
of the active ingredients does not affect the new animal drug status of 
such articles. A new animal drug application or index listing is 
required in any such case.
    (d) New animal drug applications for timed-release dosage form 
animal drugs must contain, among other things, data to demonstrate 
safety and effectiveness by establishing that the article is 
manufactured using procedures and controls to ensure release of the 
total dosage at a safe and effective rate. Data submitted in the new 
animal drug application must demonstrate that the formulation of the 
drug and the procedures used in its manufacture will ensure release of 
the active ingredient(s) of the drug at a safe and effective rate and 
that these release characteristics will be maintained until the 
expiration date of the drug. When the drug is intended for use in food-
producing animals, data submitted must also demonstrate that, with 
respect to possible residues of the drug, food derived from treated 
animals is safe for consumption.

[42 FR 8635, Feb. 11, 1977, as amended at 60 FR 38480, July 27, 1995; 72 
FR 69120, Dec. 6, 2007]



Sec. 500.27  Methylene blue-containing drugs for use in animals.

    (a) New information requires a re- evaluation of the status of drugs 
containing methylene blue (tetramethylthionine chloride) for oral use in 
cats or dogs.
    (1)(i) It has been demonstrated that two orally administered urinary 
antiseptic-antispasmodic preparations that contained methylene blue 
cause Heinz body hemolytic anemia in cats when used according to label 
directions. The specific cause of the reaction was determined to be the 
methylene blue contained in the preparations. The reaction can be severe 
enough to cause death of treated animals.
    (ii) The Heinz body hemolytic anemia reaction to methylene blue has 
also

[[Page 7]]

been demonstrated in dogs under laboratory conditions. The precise 
mechanism by which methylene blue produces the characteristic 
erythrocytic inclusion bodies (Heinz bodies) and associated hemolytic 
anemia is unclear.
    (2) The effectiveness of orally administered methylene blue as a 
urinary antiseptic is open to question. It appears that following oral 
administration, methylene blue is poorly and erratically absorbed and 
also slowly and erratically excreted in the urine. Studies in the dog 
indicate it is excreted in the urine essentially as leukomethylene blue 
stabilized in some manner. Methylene blue itself is stepwise 
demethylated in alkaline solutions (alkaline urine being a frequent 
consequence of urinary infection) to Azure B, Azure A, and Azure C. The 
antiseptic efficacy of all of these excretion products is 
unsubstantiated.
    (3) In view of the foregoing, the Commissioner has concluded that 
animal drugs containing methylene blue for oral use in cats or dogs are 
neither safe nor generally recognized as effective within the meaning of 
section 201(v) of the act and are therefore considered new animal drugs. 
Accordingly, all prior formal and informal opinions expressed by the 
Food and Drug Administration that such drugs are ``not new drugs'' or 
``no longer new drugs'' are hereby revoked.
    (b) Animal drugs that contain methylene blue for oral use in cats or 
dogs and not the subject of an approved new animal drug application 
(NADA) are deemed to be adulterated under the provisions of section 
501(a) (5) and/or (6) and/or misbranded under section 502(a) of the act 
and subject to regulatory action as of April 10, 1978.
    (c) Sponsors of animal drugs that contain methylene blue for oral 
use in cats or dogs and not the subject of an approved new animal drug 
application (NADA) may submit an application in conformity with Sec. 
514.1 of this chapter. Such applications will be processed in accordance 
with section 512 of the act. Submission of an NADA will not constitute 
grounds for continued marketing of this drug substance until such 
application is approved.
    (d) New animal drug applications required by this regulation 
pursuant to section 512 of the act shall be submitted to the Food and 
Drug Administration. Center for Veterinary Medicine, Office of New 
Animal Drug Evaluation (HFV-100), 7500 Standish Pl., Rockville, MD 
20855.

[43 FR 9803, Mar. 10, 1978; 43 FR 12310, Mar. 24, 1978, as amended at 54 
FR 18279, Apr. 28, 1989; 57 FR 6475, Feb. 25, 1992; 60 FR 38480, July 
27, 1995]



Sec. 500.29  Gentian violet for use in animal feed.

    The Food and Drug Administration has determined that gentian violet 
is not generally recognized as safe for use in animal feed and is a food 
additive subject to section 409 of the Federal Food, Drug, and Cosmetic 
Act (the act), unless it is intended for use as a new animal drug, in 
which case it is subject to section 512 of the act. The Food and Drug 
Administration has determined that gentian violet is not prior 
sanctioned for any use in animal feed.

[56 FR 40506, Aug. 15, 1991]



Sec. 500.30  Gentian violet for animal drug use.

    The Food and Drug Administration (FDA) has determined that gentian 
violet is not generally recognized as safe and effective for any 
veterinary drug use in food animals and is a new animal drug subject to 
section 512 of the Federal Food, Drug, and Cosmetic Act. FDA has 
determined that gentian violet is not exempted from new animal drug 
status under the ``grandfather'' provisions of the Drug Amendments of 
1962 (21 U.S.C. 342).

[56 FR 40507, Aug. 15, 1991]



Sec. 500.45  Use of polychlorinated biphenyls (PCB's) in the 
production, handling, and storage of animal feed.

    (a) Polychlorinated biphenyls (PCB's) represent a class of toxic 
industrial chemicals manufactured and sold under a variety of trade 
names, including: Aroclor (United States); Phenoclor (France); Colphen 
(Germany); and Kanaclor (Japan). PCB's are highly stable, heat 
resistant, and nonflammable chemicals. Industrial uses of PCB's include, 
or did include in the past, their

[[Page 8]]

use as electrical transformer and capacitor fluids, heat transfer 
fluids, hydraulic fluids, plasticizers, and in formulations of 
lubricants, coatings, and inks. Their unique physical and chemical 
properties and widespread, uncontrolled industrial applications have 
caused PCB's to be a persistent and ubiquitous contaminant in the 
environment, causing the contamination of certain foods. In addition, 
incidents have occurred in which PCB's have directly contaminated animal 
feeds as a result of industrial accidents (leakage or spillage of PCB 
fluids from plant equipment). These accidents in turn cause the 
contamination of food intended for human consumption (meat, milk, and 
eggs). Investigations by the Food and Drug Administration have revealed 
that heat exchange fluids for certain pasteurization equipment used in 
processing animal feed contain PCB's. Although heat exchange fluids in 
such equipment are considered to be in closed systems, leakage has 
occurred that resulted in direct contamination of animal feed with PCB's 
and subsequently resulted in the transfer of PCB's to human food 
produced by animals consuming the contaminated feed. The use of PCB-
containing coatings on the inner walls of silos has resulted in the 
contamination of silage which has in turn caused PCB residues in the 
milk of dairy cows consuming the contaminated silage. Since PCB's are 
toxic chemicals, the PCB contamination of food as a result of these and 
other incidents represent a hazard to public health. It is therefore 
necessary to place certain restrictions on the industrial uses of PCB's 
in the production, handling, and storage of animal feed.
    (b) The following special provisions are necessary to preclude 
accidental PCB contamination of animal feed:
    (1) Coatings or paints for use on the contact surfaces of feed 
storage areas may not contain PCB's or any other harmful or deleterious 
substances likely to contaminate feed.
    (2) New equipment or machinery for handling or processing feed in or 
around an establishment producing animal feed shall not contain PCB's.
    (3) On or before Sept. 4, 1973, the management of establishments 
producing animal feed shall:
    (i) Have the heat exchange fluid used in existing equipment or 
machinery for handling and processing feed sampled and tested to 
determine whether it contains PCB's, or verify the absence of PCB's in 
such formulations by other appropriate means. On or before Sept. 4, 
1973, any such fluid formulated with PCB's must to the fullest extent 
possible commensurate with current good manufacturing practices, be 
replaced with a heat exchange fluid that does not contain PCB's.
    (ii) Eliminate to the fullest extent possible commensurate with 
current good manufacturing practices from the animal feed producing 
establishment any PCB-containing lubricants for equipment or machinery 
used for handling or processing animal feed.
    (iii) Eliminate to the fullest extent possible commensurate with 
current good manufacturing practices from the animal feed producing 
establishment any other PCB-containing materials, whenever there is a 
reasonable expectation that such materials could cause animal feed to 
become contaminated with PCB's either as a result of normal use or as a 
result of accident, breakage, or other mishap.
    (iv) The toxicity and other characteristics of fluids selected as 
PCB replacements must be adequately determined so that the least 
potentially hazardous replacement should be used. In making this 
determination with respect to a given fluid, consideration should be 
given to (a) its toxicity; (b) the maximum quantity that could be 
spilled onto a given quantity of food before it would be noticed, taking 
into account its color and odor; (c) possible signaling devices in the 
equipment to indicate a loss of fluid, etc.; (d) and its environmental 
stability and tendency to survive and be concentrated through the food 
chain. The judgment as to whether a replacement fluid is sufficiently 
non-hazardous is to be made on an individual installation and operation 
basis.
    (c) For the purpose of this section, the provisions do not apply to 
electrical transformers and condensers containing PCB's in sealed 
containers.

[[Page 9]]

    (d) For the purpose of this section, the term animal feed includes 
all articles used for food or drink for animals other than man.



Sec. 500.46  Hexachlorophene in animal drugs.

    (a) The Commissioner of Food and Drugs has determined that there are 
no adequate data to establish that animal drugs containing 
hexachlorophene are safe and effective for any animal use other than in 
topical products for use on non-food-producing animals as part of a 
product preservative system at a level not to exceed 0.1 percent; that 
there is no information on the potential risk to humans from exposure to 
hexachlorophene by persons who apply animal products containing the drug 
at levels higher than 0.1 percent; and that there is likewise no 
information on human exposure to animals on which these animal drugs 
have been used and no information on possible residues of 
hexachlorophene in edible products of food-producing animals treated 
with new animal drugs that contain any quantity of hexachlorophene.
    (b) Animal drugs containing hexachlorophene for other than 
preservative use on non-food-producing animals at levels not exceeding 
0.1 percent are considered new animal drugs and shall be the subject of 
new animal drug applications (NADA's).
    (c) Any person currently marketing animal drugs that contain 
hexachlorophene other than as part of a product preservative system for 
products used on non-food-producing animals at a level not exceeding 0.1 
percent shall submit a new animal drug application, supplement an 
existing application, or reformulate the product by September 29, 1977. 
Each application or supplemental application shall include adequate data 
to establish that the animal drug is safe and effective. If the animal 
drug is currently subject to an approved new animal drug application, 
each reformulation shall require an approved supplemental application. 
The interim marketing of these animal drugs may continue until the 
application has been approved, until it has been determined that the 
application is not approvable under the provisions of Sec. 514.111 of 
this chapter, or until an existing approved application has been 
withdrawn.
    (d) After September 29, 1977, animal drugs that contain 
hexachlorophene other than for preservative use on non-food-producing 
animals at a level not exceeding 0.1 percent that are introduced into 
interstate commerce shall be deemed to be adulterated within the meaning 
of section 501(a)(5) of the act (21 U.S.C. 351(a)(5)) unless such animal 
drug is the subject of a new animal drug application submitted pursuant 
to paragraph (c) of this section. Action to withdraw approval of new 
animal drug applications will be initiated if supplemental new animal 
drug applications have not been submitted in accordance with this 
section.
    (e) New animal drug applications submitted for animal drugs 
containing hexachlorophene for use in or on food-producing animals shall 
include adequate data to assure that edible products from treated 
animals are safe for human consumption under the labeled conditions of 
use.

[42 FR 33725, July 1, 1977; 42 FR 37975, July 26, 1977]



Sec. 500.50  Propylene glycol in or on cat food.

    The Food and Drug Administration has determined that propylene 
glycol in or on cat food is not generally recognized as safe and is a 
food additive subject to section 409 of the Federal Food, Drug, and 
Cosmetic Act (the act). The Food and Drug Administration also has 
determined that this use of propylene glycol is not prior sanctioned.

[61 FR 19544, May 2, 1996]



               Subpart C_Animal Drug Labeling Requirements



Sec. 500.51  Labeling of animal drugs; misbranding.

    (a) Among the representations on the label or labeling of an animal 
drug which will render the drug misbranded are any broad statements 
suggesting or implying that the drug is not safe and effective for use 
when used in accordance with labeling direction, or suggesting or 
implying that the labeling does not contain adequate warnings or

[[Page 10]]

adequate directions for use. Such statements include, but are not 
limited to:
    (1) Any statement that disclaims liability when the drug is used in 
accordance with directions for use contained on the label or labeling.
    (2) Any statement that disclaims liability when the drug is used 
under ``abnormal'' or ``unforeseeable'' conditions.
    (3) Any statement limiting the warranty for the products to a 
warranty that the drug in the package contains the ingredients listed on 
the label.
    (b) This regulation is not intended to prohibit any liability 
disclaimer that purports to limit the amount of damages or that sets 
forth the legal theory under which damages are to be recovered.
    (c) Any person wishing to obtain an evaluation of an animal drug 
liability disclaimer under this regulation may submit it to Division of 
Compliance, (HFV-230), Center for Veterinary Medicine, Food and Drug 
Administration, 7500 Standish Pl., Rockville, MD 20855. A supplemental 
NADA providing appropriately revised labeling shall be submitted for any 
approved new animal drug the labeling of which is not in compliance with 
this regulation.

[41 FR 8473, Feb. 27, 1976, as amended at 54 FR 18279, Apr. 28, 1989; 57 
FR 6475, Feb. 25, 1992]



Sec. 500.52  Use of terms such as ``tonic'', ``tone'', ``toner'',
or ``conditioner'' in the labeling of preparations intended for use
in or on animals.

    (a) The use of terms such as tonic, tone, toner, and similar terms 
in the labeling of a product intended for use in or on animals implies 
that such product is capable of a therapeutic effect(s) and causes such 
a product to be a drug within the meaning of section 201(g) of the 
Federal Food, Drug, and Cosmetic Act. The unqualified use of such terms 
in a product's labeling fails to provide adequate directions and 
indications for use of such product and causes it to be misbranded 
within the meaning of section 502(a) and (f)(1) of the act. The terms 
tonic, tone, toner, and similar terms may be used in labeling only when 
appropriately qualified so as to fully inform the user regarding the 
intended use(s) of the product.
    (b) The unqualified use of the term conditioner and similar terms in 
the labeling of a product intended for use in or on animals implies that 
such product is capable of a therapeutic effect(s) and causes such a 
product to be a drug within the meaning of section 201(g) of the act. 
The unqualified use of such terms in a product's labeling fails to 
provide adequate directions and indications for use of such product and 
causes it to be misbranded within the meaning of section 502(a) and 
(f)(1) of the act. The term conditioner and similar terms may be used in 
labeling only when appropriately qualified so as to fully inform the 
user regarding the intended use(s) of the product. A product labeled as 
a ``conditioner'' or with a similar term can be either a food or drug 
depending upon the manner in which the term is qualified in the labeling 
to reflect the product's intended use.
    (c) An article so qualified as to be represented as a drug must be 
the subject of an approved new animal drug application unless the use of 
the article under the conditions set forth in its labeling is generally 
recognized as safe and effective among experts qualified by scientific 
training and experience to evaluate the safety and effectiveness of 
animal drugs.



Sec. 500.55  Exemption from certain drug-labeling requirements.

    (a) Section 201.105(c) of this chapter provides that in the case of 
certain drugs for which directions, hazards, warnings, and use 
information are commonly known to practitioners licensed by law, such 
information may be omitted from the dispensing package. Under this 
proviso, the Commissioner of Food and Drugs will offer an opinion, upon 
written request, stating reasonable grounds therefore on a proposal to 
omit such information from the dispensing package.
    (b) The Commissioner of Food and Drugs has considered submitted 
material covering a number of drug products and has offered the opinion 
that the following drugs when intended for those veterinary uses for 
which they are now generally employed by the veterinary medical 
profession, should be exempt from the requirements of

[[Page 11]]

Sec. 201.105(c) of this chapter, provided that they meet the conditions 
prescribed in this paragraph. Preparations that are not in dosage unit 
form (for example, solutions) will be regarded as meeting the conditions 
with respect to the maximum quantity of drug per dosage unit if they are 
prepared in a manner that enables accurate and ready administration of a 
quantity of drug not in excess of the stated maximum per dosage unit:

Atropine sulfate. As an injectable for cattle, goats, horses, pigs, and 
sheep, not in excess of 15 milligrams per dosage unit; as an injectable 
for cats and dogs, not in excess of 0.6 milligram per dosage unit.
Barbital sodium. For oral use in cats and dogs, not in excess of 300 
milligrams per dosage unit.
Epinephrine injection. 1:1,000. For cats, dogs, cattle, goats, horses, 
pigs, and sheep (except as provided in Sec. 500.65).
Morphine sulfate. As an injectable for dogs, not in excess of 15 
milligrams per dosage unit.
Pentobarbital sodium. For oral use in cats and dogs, not in excess of 
100 milligrams per dosage unit.
Phenobarbital sodium. For oral use in cats and dogs, not in excess of 
100 milligrams per dosage unit.
Procaine hydrochloride injection. Containing not in excess of 2 percent 
procaine hydrochloride, with or without epinephrine up to a 
concentration of 1:50,000. For use in cats, dogs, cattle, goats, horses, 
pigs, and sheep.
Thyroid. For oral use in dogs, not in excess of 60 milligrams per dosage 
unit.



            Subpart D_Requirements for Specific Animal Drugs



Sec. 500.65  Epinephrine injection 1:1,000 in 10-milliliter containers
for emergency treatment of anaphylactoid shock in cattle, horses,
sheep, and swine.

    (a) Anaphylactoid reactions in cattle, horses, sheep, and swine 
occur occasionally from the injection of antibiotics, bacterins, and 
vaccines. Adequate directions for use of these antibiotics, bacterins, 
and vaccines can generally be written for use by the laity and thus are 
available to livestock producers. Epinephrine injection is effective for 
the treatment of anaphylactoid reactions in animals and would be of 
value in saving lives of animals if it were readily available at the 
time of administration of the causative agents. In connection with this 
problem the Food and Drug Administration has obtained the views of the 
Advisory Committee on Veterinary Medicine, and other experts, and has 
concluded that adequate directions for over-the-counter sale of 
epinephrine injection 1:1,000 can be prepared.
    (b) In view of the above, the Commissioner of Food and Drugs has 
concluded that it is in the public interest to make epinephrine 
injection 1:1,000 available for sale without a prescription provided 
that it is packaged in vials not exceeding 10 milliliters and its label 
bears, in addition to other required information, the following 
statements in a prominent and conspicuous manner: ``For emergency use 
only in treating anaphylactoid shock. Usual Dosage: Cattle, horses, 
sheep, and swine--1 cubic centimeter per 100 pounds of body weight. 
Inject subcutaneously''.
    (c) The labeling must also bear a description of the symptoms of 
anaphylactoid shock including glassy eyes, increased salivation, 
grinding of the teeth, rapid breathing, muscular tremors, staggering 
gait, and collapse with death following. These symptoms may appear 
shortly after injection of a bacterin, vaccine, or antibiotic.



 Subpart E_Regulation of Carcinogenic Compounds Used in Food-Producing 
                                 Animals

    Source: 52 FR 49586, Dec. 31, 1987, unless otherwise noted.



Sec. 500.80  Scope of this subpart.

    (a) The Federal Food, Drug, and Cosmetic Act requires that sponsored 
compounds intended for use in food-producing animals be shown to be safe 
and that food produced from animals exposed to these compounds be shown 
to be safe for consumption by people. The statute prohibits the use in 
food-producing animals of any compound found to induce cancer when 
ingested by people or animals unless it can be determined by methods of 
examination prescribed or approved by the Secretary (a function 
delegated to the Commissioner of Food and Drugs) that no residue of that 
compound will be found in the food produced from those animals

[[Page 12]]

under conditions of use reasonably certain to be followed in practice. 
This subpart identifies the steps a sponsor of a compound shall follow 
to secure the approval of the compound. FDA guidance documents contain 
the procedures and protocols FDA recommends for the implementation of 
this subpart. These guidance documents are available from the Division 
of Dockets Management (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, rm. 1061, Rockville, MD 20852. Requests for these guidance 
documents should be identified with Docket No. 1983D-0288.
    (b) If FDA concludes on the basis of the threshold assessment that a 
sponsor shall conduct carcinogenicity testing on the sponsored compound, 
FDA will also determine whether and to what extent the sponsor shall 
conduct carcinogenicity testing on metabolites of the sponsored 
compound. The bioassays that a sponsor conducts must be designed to 
assess carcinogenicity and to determine the quantitative aspects of any 
carcinogenic response.
    (c) If FDA concludes on the basis of the threshold assessment or at 
a later time during the approval process that the data show that the 
sponsored compound and its metabolites should not be subject to this 
subpart, FDA will continue to consider the compound for approval under 
the general safety provisions of the act for risks other than cancer.
    (d) This subpart does not apply to essential nutrients.

[52 FR 49586, Dec. 31, 1987, as amended at 59 FR 14365, Mar. 28, 1994; 
62 FR 66983, Dec. 23, 1997; 65 FR 56480, Sept. 19, 2000; 67 FR 78174, 
Dec. 23, 2002; 68 FR 24879, May 9, 2003; 69 FR 17292, Apr. 2, 2004]



Sec. 500.82  Definitions.

    (a) The definitions and interpretations contained in section 201 of 
the act apply to those terms when used in this subpart.
    (b) The following definitions apply to this subpart:
    Act means the Federal Food, Drug, and Cosmetic Act (sections 201-
901, 52 Stat. 1040 et seq. as amended (21 U.S.C. 301-392)).
    Essential nutrients means compounds that are found in the tissues of 
untreated, healthy target animals and not produced in sufficient 
quantity to support the animal's growth, development, function, or 
reproduction, e.g., vitamins, essential minerals, essential amino acids, 
and essential fatty acids. These compounds must be supplied from 
external sources.
    FDA means the Food and Drug Administration.
    Limit of detection (LOD) means the lowest concentration of analyte 
that can be confirmed by the approved regulatory method.
    Marker residue means the residue selected for assay whose 
concentration is in a known relationship to the concentration of the 
residue of carcinogenic concern in the last tissue to deplete to its 
Sm.
    No residue means the marker residue is below the limit of detection 
using the approved regulatory method. The ``no residue'' designation 
applies only to compounds of carcinogenic concern.
    Preslaughter withdrawal period or milk discard time means the time 
after cessation of administration of the sponsored compound at which no 
residue is detectable in the edible product using the approved 
regulatory method (i.e., the marker residue is below the LOD).
    Regulatory method means the aggregate of all experimental procedures 
for measuring and confirming the presence of the marker residue of the 
sponsored compound in the target tissue of the target animal.
    Rm means the concentration of the marker residue in the 
target tissue when the residue of carcinogenic concern is equal to 
Sm.
    Residue means any compound present in edible tissues of the target 
animal which results from the use of the sponsored compound, including 
the sponsored compound, its metabolites, and any other substances formed 
in or on food because of the sponsored compound's use.
    Residue of carcinogenic concern means all compounds in the total 
residue of a demonstrated carcinogen excluding any compounds judged by 
FDA not to present a carcinogenic risk.
    Sm means the concentration of a residue of carcinogenic concern in a 
specific edible tissue corresponding to no significant increase in the 
risk of cancer to the human consumer. For the

[[Page 13]]

purpose of Sec. 500.84(c)(1), FDA will assume that this Sm 
will correspond to the concentration of residue in a specific edible 
tissue that corresponds to a maximum lifetime risk of cancer in the test 
animals of 1 in 1 million.
    So means the concentration of a residue of carcinogenic concern in 
the total human diet that represents no significant increase in the risk 
of cancer to the human consumer. For the purpose of Sec. 500.84(c)(1), 
FDA will assume that this So will correspond to the 
concentration of test compound in the total diet of test animals that 
corresponds to a maximum lifetime risk of cancer in the test animals of 
1 in 1 million.
    Sponsor means the person or organization proposing or holding an 
approval by FDA for the use of a sponsored compound.
    Sponsored compound means any drug or food additive or color additive 
proposed for use, or used, in food-producing animals or in their feed.
    Target animals means the production class of animals in which a 
sponsored compound is proposed or intended for use.
    Target tissue means the edible tissue selected to monitor for 
residues in the target animals, including, where appropriate, milk or 
eggs.
    Test animals means the species selected for use in the toxicity 
tests.
    Threshold assessment means FDA's review of data and information 
about a sponsored compound to determine whether chronic bioassays in 
test animals are necessary to resolve questions concerning the 
carcinogenicity of the compound.

[52 FR 49586, Dec. 31, 1987, as amended at 67 FR 78174, Dec. 23, 2002; 
77 FR 50593, Aug. 22, 2012; 84 FR 32992, July 11, 2019]



Sec. 500.84  Conditions for approval of the sponsored compound.

    (a) On the basis of the results of the chronic bioassays and other 
information, FDA will determine whether any of the substances tested are 
carcinogenic.
    (b) If FDA concludes that the results of the bioassays do not 
establish carcinogenicity, then FDA will not subject the sponsored 
compound to the remainder of the requirements of this subpart.
    (c) For each sponsored compound that FDA decides should be regulated 
as a carcinogen, FDA will either analyze the data from the bioassays 
using a statistical extrapolation procedure as outlined in paragraph 
(c)(1) of this section or evaluate an alternate procedure proposed by 
the sponsor as provided in Sec. 500.90. In either case, paragraphs 
(c)(2) and (3) of this section apply.
    (1) For each substance tested in separate bioassays, FDA will 
calculate the concentration of the residue of carcinogenic concern that 
corresponds to a maximum lifetime risk to the test animal of 1 in 1 
million. FDA will designate the lowest value obtained as So. 
Because the total diet is not derived from food-producing animals, FDA 
will make corrections for food intake. FDA will designate as 
Sm the concentration of residue in a specific edible tissue 
corresponding to a maximum lifetime risk of cancer in test animals of 1 
in 1 million.
    (2) From the appropriate residue chemistry data FDA will calculate 
the Rm as described in Sec. 500.86(c). The sponsor must 
provide a regulatory method in accordance with Sec. 500.88(b). FDA will 
calculate the LOD of the method from data submitted by the sponsor under 
Sec. 500.88. The LOD must be less than or equal to Rm.
    (3) FDA will conclude that the provisions of this subpart are 
satisfied when no residue of the compound is detectable (that is, the 
marker residue is below the LOD) using the approved regulatory method 
under the conditions of use of the sponsored compound, including any 
required preslaughter withdrawal period or milk discard time.

[52 FR 49586, Dec. 31, 1987, as amended at 67 FR 78174, Dec. 23, 2002; 
77 FR 50593, Aug. 22, 2012]



Sec. 500.86  Marker residue and target tissue.

    (a) For each edible tissue, the sponsor shall measure the depletion 
of the residue of carcinogenic concern until its concentration is at or 
below Sm.
    (b) In one or more edible tissues, the sponsor shall also measure 
the depletion of one or more potential marker residues until the 
concentration of the

[[Page 14]]

residue of carcinogenic concern is at or below Sm.
    (c) From these data, FDA will select a target tissue and a marker 
residue and designate the concentration of marker residue 
(Rm) that the regulatory method must be capable of measuring 
in the target tissue. FDA will select Rm such that the 
absence of the marker residue in the target tissue above Rm 
can be taken as confirmation that the residue of carcinogenic concern 
does not exceed Sm in each of the edible tissues and, 
therefore, that the residue of carcinogenic concern in the diet of 
people does not exceed So.
    (d) When a compound is to be used in milk- or egg-producing animals, 
milk or eggs must be the target tissue in addition to the tissue 
selected to monitor for residues in the edible carcass.

(Approved by the Office of Management and Budget under control number 
0910-0228)



Sec. 500.88  Regulatory method.

    (a) The sponsor shall submit for evaluation and validation a 
regulatory method developed to monitor compliance with FDA's operational 
definition of no residue.
    (b) The regulatory method must be able to confirm the identity of 
the marker residue in the target tissue at a minimum concentration 
corresponding to the Rm. FDA will determine the LOD from the 
submitted analytical method validation data.
    (c) FDA will publish in the Federal Register the complete regulatory 
method for ascertaining the marker residue in the target tissue in 
accordance with the provisions of sections 409(c)(3)(A), 512(d)(1)(I), 
and 721(b)(5)(B) of the act.

(Approved by the Office of Management and Budget under control number 
0910-0228)

[52 FR 49586, Dec. 31, 1987, as amended at 67 FR 78174, Dec. 23, 2002]



Sec. 500.90  Waiver of requirements.

    In response to a petition or on the Commissioner's own initiative, 
the Commissioner may waive, in whole or in part, the requirements of 
this subpart except those provided under Sec. 500.88. A petition for 
this waiver may be filed by any person who would be adversely affected 
by the application of the requirements to a particular compound. The 
petition shall explain and document why the requirements from which a 
waiver is requested are not reasonably applicable to the compound, and 
set forth clearly the reasons why the alternative procedures will 
provide the basis for concluding that approval of the compound satisfies 
the requirements of the anticancer provisions of the act. If the 
Commissioner determines that waiver of any of the requirements of this 
subpart is appropriate, the Commissioner will state the basis for that 
determination in the regulation approving marketing of the sponsored 
compound.

(Approved by the Office of Management and Budget under control number 
0910-0228)



Sec. 500.92  Implementation.

    (a) This subpart E applies to all new animal drug applications, food 
additive petitions, and color additive petitions concerning any compound 
intended for use in food-producing animals (including supplemental 
applications and amendments to petitions).
    (b) This subpart E also applies in the following manner to compounds 
already approved:
    (1) For those compounds that FDA determines may induce cancer when 
ingested by man or animals, i.e., suspect carcinogens, Sec. Sec. 
500.80(b), 500.82, and 500.90 apply.
    (2) For those compounds that FDA determines have been shown to 
induce cancer when ingested by man or animals, Sec. Sec. 500.82 through 
500.90 apply.



 Subpart F_Methods for Detection of Residues of Carcinogenic Compounds 
                     Used in Food-Producing Animals

    Source: 76 FR 72618, Nov. 25, 2011, unless otherwise noted.



Sec. 500.1410  N-methyl-2-pyrrolidone.

    (a) Standard for residues. No residues of n-methyl-2-pyrrolidone may 
be found in the uncooked edible tissues of cattle as determined by a 
method entitled ``Method of Analysis: N-methyl-2-pyrrolidone,'' 
September 26, 2011, Center for Veterinary Medicine, Food and

[[Page 15]]

Drug Administration, which is incorporated by reference with the 
approval of the Director of the Federal Register under 5 U.S.C. 522(a) 
and 1 CFR part 51. To obtain a copy of the analytical method, please 
submit a Freedom of Information request to: https://
www.accessdata.fda.gov/scripts /foi/FOIRequest/requestinfo.cfm; or go 
to: https://www.fda.gov /about-fda/center-veterinary -medicine/cvm-foia-
electronic-reading-room. You may inspect a copy at the office of the 
Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, Rm. 1061, Rockville, MD 20852, 301-827-6860, between 9 
a.m. and 4 p.m., Monday through Friday or at the National Archives and 
Records Administration (NARA). For information on the availability of 
this material at NARA, email [email protected], or go to: 
www.archives.gov/federal-register /cfr/ibr-locations.html.
    (b) Related conditions of use. See Sec. Sec. 522.814 and 522.955 of 
this chapter.

[76 FR 72618, Nov. 25, 2011, as amended at 77 FR 9528, Feb. 17, 2012; 85 
FR 18117, Apr. 1, 2020]



PART 501_ANIMAL FOOD LABELING--Table of Contents



                      Subpart A_General Provisions

Sec.
501.1 Principal display panel of package form animal food.
501.2 Information panel of package for animal food.
501.3 Identity labeling of animal food in package form.
501.4 Animal food; designation of ingredients.
501.5 Animal food; name and place of business of manufacturer, packer, 
          or distributor.
501.8 Labeling of animal food with number of servings.
501.15 Animal food; prominence of required statements.
501.17 Animal food labeling warning statements.
501.18 Misbranding of animal food.

          Subpart B_Specific Animal Food Labeling Requirements

501.22 Animal foods; labeling of spices, flavorings, colorings, and 
          chemical preservatives.

Subparts C-E [Reserved]

       Subpart F_Exemptions From Animal Food Labeling Requirements

501.100 Animal food; exemptions from labeling.
501.103 Petitions requesting exemptions from or special requirements for 
          label declaration of ingredients.
501.105 Declaration of net quantity of contents when exempt.
501.110 Animal feed labeling; collective names for feed ingredients.

    Authority: 15 U.S.C. 1453, 1454, 1455; 21 U.S.C. 321, 331, 342, 343, 
348, 371.

    Source: 41 FR 38619, Sept. 10, 1976, unless otherwise noted.



                      Subpart A_General Provisions



Sec. 501.1  Principal display panel of package form animal food.

    The term principal display panel as it applies to food in package 
form and as used in this part, means the part of a label that is most 
likely to be displayed, presented, shown, or examined under customary 
conditions of display for retail sale. The principal display panel shall 
be large enough to accommodate all the mandatory label information 
required to be placed thereon by this part with clarity and 
conspicuousness and without obscuring design, vignettes, or crowding. 
Where packages bear alternate principal display panels, information 
required to be placed on the principal display panel shall be duplicated 
on each principal display panel. For the purpose of obtaining uniform 
type size in declaring the quantity of contents for all packages of 
substantially the same size, the term area of the principal display 
panel means the area of the side or surface that bears the principal 
display panel, which area shall be:
    (a) In the case of a rectangular package where one entire side 
properly can be considered to be the principal display panel side, the 
product of the height times the width of that side;
    (b) In the case of a cylindrical or nearly cylindrical container, 40 
percent of the product of the height of the container times the 
circumference;
    (c) In the case of any otherwise shaped container, 40 percent of the 
total surface of the container: Provided,

[[Page 16]]

however, That where such container presents an obvious principal display 
panel such as the top of a triangular or circular package, the area 
shall consist of the entire top surface. In determining the area of the 
principal display panel, exclude tops, bottoms, flanges at tops and 
bottoms of cans, and shoulders and necks of bottles or jars. In the case 
of cylindrical or nearly cylindrical containers, information required by 
this part to appear on the principal display panel shall appear within 
that 40 percent of the circumference which is most likely to be 
displayed, presented, shown, or examined under customary conditions of 
display for retail sale.



Sec. 501.2  Information panel of package for animal food.

    (a) The term information panel as it applies to packaged food means 
that part of the label immediately contiguous and to the right of the 
principal display panel as observed by an individual facing the 
principal display panel with the following exceptions:
    (1) If the part of the label immediately contiguous and to the right 
of the principal display panel is too small to accommodate the necessary 
information or is otherwise unusable label space, e.g., folded flaps or 
can ends, the panel immediately contiguous and to the right of this part 
of the label may be used.
    (2) If the package has one or more alternate principal display 
panels, the information panel is immediately contiguous and to the right 
of any principal display panel.
    (3) If the top of the container is the principal display panel and 
the package has no alternate principal display panel, the information 
panel is any panel adjacent to the principal display panel.
    (b) All information required to appear on the label of any package 
of food pursuant to Sec. Sec. 501.4, 501.5, 501.8 and 501.17 shall 
appear either on the principal display panel or on the information 
panel, unless otherwise specified by regulations in this chapter.
    (c) All information appearing on the principal display panel or the 
information panel pursuant to this section shall appear prominently and 
conspicuously, but in no case may the letters and/or numbers be less 
than \1/16\ inch in height unless an exemption pursuant to paragraph (f) 
of this section is established. The requirements for conspicuousness and 
legibility shall include the specifications of Sec. Sec. 501.15 and 
501.105(h) (1) and (2).
    (1) Packaged foods are exempt from the type size requirements of 
this paragraph: Provided, That:
    (i) The package is designed such that it has a surface area that can 
bear an information panel and/or an alternate principal display panel.
    (ii) The area of surface available for labeling on the principal 
display panel of the package as this term is defined in Sec. 501.1 is 
less than 10 square inches.
    (iii) The label information includes a full list of ingredients in 
accordance with regulations in this part.
    (iv) The information required by paragraph (b) of this section 
appears on the principal display panel or information panel label in 
accordance with the provisions of this paragraph (c) except that the 
type size is not less than \3/64\ inch in height.
    (2) Packaged foods are exempt from the type size requirements of 
this paragraph: Provided, That:
    (i) The package is designed such that it has a single obvious 
principal display panel as this term is defined in Sec. 501.1 and has 
no other available surface area for an information panel or alternate 
principal display panel.
    (ii) The area of surface available for labeling on the principal 
display panel of the package as this term is defined in Sec. 501.1 is 
less than 12 square inches and bears all labeling appearing on the 
package.
    (iii) The label information includes a full list of ingredients in 
accordance with regulations in this part.
    (iv) The information required by paragraph (b) of this section 
appears on the single, obvious principal display panel in accordance 
with the provisions of this paragraph (c) except that the type size is 
not less than \1/32\ inch in height.
    (3) Packaged foods are exempt from the type size requirements of 
this paragraph: Provided, That:
    (i) The package is designed such that it has a total surface area 
available to

[[Page 17]]

bear labeling of less than 12 square inches.
    (ii) The label information includes a full list of ingredients in 
accordance with regulations in this part.
    (iii) The information required by paragraph (b) of this section 
appears on the principal display panel or information panel label in 
accordance with the provisions of this paragraph (c) except that the 
type size is not less than \1/32\ inch in height.
    (d) All information required to appear on the principal display 
panel or on the information panel pursuant to this section shall appear 
on the same panel unless there is insufficient space. In determining the 
sufficiency of the available space, any vignettes, design, and other 
nonmandatory label information shall not be considered. If there is 
insufficient space for all of this information to appear on a single 
panel, it may be divided between these two panels except that the 
information required pursuant to any given section or part shall all 
appear on the same panel. A food whose label is required to bear the 
ingredient statement on the principal display panel may bear all other 
information specified in paragraph (b) of this section on the 
information panel.
    (e) All information appearing on the information panel pursuant to 
this section shall appear in one place without other intervening 
material.
    (f) If the label of any package of food is too small to accommodate 
all of the information required by Sec. Sec. 501.4, 501.5, 501.8, and 
501.17, the Commissioner may establish by regulation an acceptable 
alternative method of disseminating such information to the public, 
e.g., a type size smaller than one-sixteenth inch in height, or labeling 
attached to or inserted in the package or available at the point of 
purchase. A petition requesting such a regulation, as an amendment to 
this paragraph shall be submitted pursuant to part 10 of this chapter.

[41 FR 38619, Sept. 10, 1976, as amended at 42 FR 4716, Jan. 25, 1977; 
42 FR 15675, Mar. 22, 1977]



Sec. 501.3  Identity labeling of animal food in package form.

    (a) The principal display panel of a food in package form shall bear 
as one of its principal features a statement of the identity of the 
commodity.
    (b) Such statement of identity shall be in terms of:
    (1) The name now or hereafter specified in or required by any 
applicable Federal law or regulation; or, in the absence thereof,
    (2) The common or usual name of the food; or, in the absence 
thereof,
    (3) An appropriately descriptive term, or when the nature of the 
food is obvious, a fanciful name commonly used by the public for such 
food.
    (c) Where a food is marketed in various optional forms (whole, 
slices, diced, etc.), the particular form shall be considered to be a 
necessary part of the statement of identity and shall be declared in 
letters of a type size bearing a reasonable relation to the size of the 
letters forming the other components of the statement of identity; 
except that if the optional form is visible through the container or is 
depicted by an appropriate vignette, the particular form need not be 
included in the statement. This specification does not affect the 
required declarations of identity under definitions and standards for 
foods promulgated pursuant to section 401 of the act.
    (d) This statement of identity shall be presented in bold type on 
the principal display panel, shall be in a size reasonably related to 
the most prominent printed matter on such panel, and shall be in lines 
generally parallel to the base on which the package rests as it is 
designed to be displayed.
    (e) Under the provisions of section 403(c) of the Federal Food, 
Drug, and Cosmetic Act, a food shall be deemed to be misbranded if it is 
an imitation of another food unless its label bears, in type of uniform 
size and prominence, the word imitation and, immediately thereafter, the 
name of the food imitated.
    (1) A food shall be deemed to be an imitation and thus subject to 
the requirements of section 403(c) of the act if it is a substitute for 
and resembles another food but is nutritionally inferior to that food.

[[Page 18]]

    (2) A food that is a substitute for and resembles another food shall 
not be deemed to be an imitation provided it meets each of the following 
requirements:
    (i) It is not nutritionally inferior to the food for which it 
substitutes and which it resembles.
    (ii) Its label bears a common or usual name that complies with the 
provisions of Sec. 502.5 of this chapter and that is not false or 
misleading, or in the absence of an existing common or usual name, an 
appropriately descriptive term that is not false or misleading. The 
label may, in addition, bear a fanciful name which is not false or 
misleading.
    (3) A food for which a common or usual name is established by 
regulation (e.g., in a standard of identity pursuant to section 401 of 
the act, in a common or usual name regulation and may, in addition, bear 
a fanciful name which is not false or misleading, and established 
pursuant to part 502 of this chapter), and which complies with all of 
the applicable requirements of such regulation(s), shall not be deemed 
to be an imitation.
    (4) Nutritional inferiority includes:
    (i) Any reduction in the content of an essential nutrient that is 
present in a measurable amount.
    (ii) If the Commissioner concludes that a food is a substitute for 
and resembles another food but is inferior to the food imitated for 
reasons other than those set forth in this paragraph, he may propose 
appropriate revisions to this regulation or he may propose a separate 
regulation governing the particular food.
    (f) A label may be required to bear the percentage(s) of a 
characterizing ingredient(s) or information concerning the presence or 
absence of an ingredient(s) or the need to add an ingredient(s) as part 
of the common or usual name of the food pursuant to part 502 of this 
chapter.

[41 FR 38619, Sept. 10, 1976, as amended at 42 FR 14091, Mar. 15, 1977; 
54 FR 18279, Apr. 28, 1989]



Sec. 501.4  Animal food; designation of ingredients.

    (a) Ingredients required to be declared on the label of a food, 
including foods that comply with standards of identity that require 
labeling in compliance with this part 501, except those exempted by 
Sec. 501.100, shall be listed by common or usual name in descending 
order of predominance by weight on either the principal display panel or 
the information panel in accordance with the provisions of Sec. 501.2.
    (b) The name of an ingredient shall be a specific name and not a 
collective (generic) name, except that:
    (1) Spices, flavorings, colorings and chemical preservatives shall 
be declared according to the provisions of Sec. 501.22.
    (2) An ingredient which itself contains two or more ingredients and 
which has an established common or usual name, conforms to a standard 
established pursuant to the Meat Inspection or Poultry Products 
Inspection Acts by the U.S. Department of Agriculture, or conforms to a 
definition and standard of identity established pursuant to section 401 
of the Federal Food, Drug, and Cosmetic Act, shall be designated in the 
statement of ingredients on the label of such food by either of the 
following alternatives:
    (i) By declaring the established common or usual name of the 
ingredient followed by a parenthetical listing of all ingredients 
contained therein in descending order of predominance except that, if 
the ingredient is a food subject to a definition and standard of 
identity established in this subchapter E, only the ingredients required 
to be declared by the definition and standard of identity need be 
listed; or
    (ii) By incorporating into the statement of ingredients in 
descending order of predominance in the finished food, the common or 
usual name of every component of the ingredient without listing the 
ingredient itself.
    (3) Skim milk, concentrated skim milk, reconstituted skim milk, and 
nonfat dry milk may be declared as skim milk or nonfat milk.
    (4) Milk, concentrated milk, reconstituted milk, and dry whole milk 
may be declared as milk.
    (5) Bacterial cultures may be declared by the word cultured followed 
by the name of the substrate, e.g., made from cultured skim milk or 
cultured buttermilk.

[[Page 19]]

    (6) Sweetcream buttermilk, concentrated sweetcream buttermilk, 
reconstituted sweetcream buttermilk, and dried sweetcream buttermilk may 
be declared as buttermilk.
    (7) Whey, concentrated whey, reconstituted whey, and dried whey may 
be declared as whey.
    (8) Cream, reconstituted cream, dried cream, and plastic cream 
(sometimes known as concentrated milkfat) may be declared as cream.
    (9) Butteroil and anhydrous butterfat may be declared as butterfat.
    (10) Dried whole eggs, frozen whole eggs, and liquid whole eggs may 
be declared as eggs.
    (11) Dried egg whites, frozen egg whites, and liquid egg whites may 
be declared as egg whites.
    (12) Dried egg yolks, frozen egg yolks, and liquid egg yolks may be 
declared as egg yolks.
    (13) A livestock or poultry feed may be declared by a collective 
name listed in Sec. 501.110 if it is an animal feed within the meaning 
of section 201(w) of the act and meets the requirements for the use of a 
collective name as prescribed in Sec. 501.110 for certain feed 
ingredients.
    (14) [Reserved]
    (15) When all the ingredients of a wheat flour are declared in an 
ingredient statement, the principal ingredient of the flour shall be 
declared by the name(s) specified in Sec. Sec. 137.105, 137.200, 
137.220, 137.225 of this chapter, i.e., the first ingredient designated 
in the ingredient list of flour, or bromated flour, or enriched flour, 
or self-rising flour is flour, white flour, wheat flour, or plain flour; 
the first ingredient designated in the ingredient list of durum flour is 
durum flour; the first ingredient designated in the ingredient list of 
whole wheat flour, or bromated whole wheat flour is whole wheat flour, 
graham flour, or entire wheat flour; and the first ingredient designated 
in the ingredient list of whole durum wheat flour is whole durum wheat 
flour.
    (c) When water is added to reconstitute, completely or partially, an 
ingredient permitted by paragraph (b) of this section to be declared by 
a class name, the position of the ingredient class name in the 
ingredient statement shall be determined by the weight of the 
unreconstituted ingredient plus the weight of the quantity of water 
added to reconstitute that ingredient, up to the amount of water needed 
to reconstitute the ingredient to single strength. Any water added in 
excess of the amount of water needed to reconstitute the ingredient to 
single strength shall be declared as water in the ingredient statement.

[41 FR 38619, Sept. 10, 1976, as amended at 42 FR 14091, Mar. 15, 1977; 
60 FR 38480, July 27, 1995]



Sec. 501.5  Animal food; name and place of business of manufacturer,
packer, or distributor.

    (a) The label of a food in packaged form shall specify conspicuously 
the name and place of business of the manufacturer, packer, or 
distributor.
    (b) The requirement for declaration of the name of the manufacturer, 
packer, or distributor shall be deemed to be satisfied, in the case of a 
corporation, only by the actual corporate name, which may be preceded or 
followed by the name of the particular division of the corporation. In 
the case of an individual, partnership, or association, the name under 
which the business is conducted shall be used.
    (c) Where the food is not manufactured by the person whose name 
appears on the label, the name shall be qualified by a phrase that 
reveals the connection such person has with such food; such as 
``Manufactured for ______,'' ``Distributed by ______,'' or any other 
wording that expresses the facts.
    (d) The statement of the place of business shall include the street 
address, city, state, and ZIP Code; however, the street address may be 
omitted if it is shown in a current city directory or telephone 
directory. The requirement for inclusion of the ZIP Code shall apply 
only to consumer commodity labels developed or revised after the 
effective date of this section. In the case of nonconsumer packages, the 
ZIP Code shall appear either on the label or the labeling (including 
invoice).
    (e) If a person manufactures, packs, or distributes a food at a 
place other than his principal place of business, the label may state 
the principal place of

[[Page 20]]

business in lieu of the actual place where such food was manufactured or 
packed or is to be distributed, unless such statement would be 
misleading.



Sec. 501.8  Labeling of animal food with number of servings.

    (a) The label of any package of a food which bears a representation 
as to the number of servings contained in such package shall bear in 
immediate conjunction with such statement, and in the same size type as 
is used for such statement, a statement of the net quantity (in terms of 
weight, measure, or numerical count) of each such serving; however, such 
statement may be expressed in terms that differ from the terms used in 
the required statement of net quantity of contents (for example, 
cupfuls, tablespoonfuls, etc.) when such differing term is common to 
cookery and describes a constant quantity. Such statement may not be 
misleading in any particular. A statement of the number of units in a 
package is not in itself a statement of the number of servings.
    (b) If there exists a voluntary product standard promulgated 
pursuant to the procedures found in 15 CFR part 10 by the Department of 
Commerce, quantitatively defining the meaning of the term serving with 
respect to a particular food, then any label representation as to the 
number of servings in such packaged food shall correspond with such 
quantitative definition. (Copies of published standards are available 
upon request from the National Bureau of Standards, Department of 
Commerce, Washington, DC 20234.)



Sec. 501.15  Animal food; prominence of required statements.

    (a) A word, statement, or other information required by or under 
authority of the act to appear on the label may lack that prominence and 
conspicuousness required by section 403(f) of the act by reason (among 
other reasons) of:
    (1) The failure of such word, statement, or information to appear on 
the part or panel of the label which is presented or displayed under 
customary conditions of purchase;
    (2) The failure of such word, statement, or information to appear on 
two or more parts or panels of the label, each of which has sufficient 
space therefor, and each of which is so designed as to render it likely 
to be, under customary conditions of purchase, the part or panel 
displayed;
    (3) The failure of the label to extend over the area of the 
container or package available for such extension, so as to provide 
sufficient label space for the prominent placing of such word, 
statement, or information;
    (4) Insufficiency of label space (for the prominent placing of such 
word, statement, or information) resulting from the use of label space 
for any word, statement, design, or device which is not required by or 
under authority of the act to appear on the label;
    (5) Insufficiency of label space (for the prominent placing of such 
word, statement, or information) resulting from the use of label space 
to give materially greater conspicuousness to any other word, statement, 
or information, or to any design or device; or
    (6) Smallness or style of type in which such word, statement, or 
information appears, insufficient background contrast, obscuring designs 
or vignettes, or crowding with other written, printed, or graphic 
matter.
    (b) No exemption depending on insufficiency of label space, as 
prescribed in regulations promulgated under section 403(e) or (i) of the 
act, shall apply if such insufficiency is caused by:
    (1) The use of label space for any word, statement, design, or 
device which is not required by or under authority of the act to appear 
on the label;
    (2) The use of label space to give greater conspicuousness to any 
word, statement, or other information that is required by section 403(f) 
of the act; or
    (3) The use of label space for any representation in a foreign 
language.
    (c)(1) All words, statements, and other information required by or 
under authority of the act to appear on the label or labeling shall 
appear thereon in the English language: Provided, however, That in the 
case of articles distributed solely in the Commonwealth of Puerto Rico 
or in a territory where the predominant language is one other

[[Page 21]]

than English, the predominant language may be substituted for English.
    (2) If the label contains any representation in a foreign language, 
all words, statements, and other information required by or under 
authority of the act to appear on the label shall appear thereon in the 
foreign language.
    (3) If any article of labeling (other than a label) contains any 
representation in a foreign language, all words, statements, and other 
information required by or under authority of the act to appear on the 
label or labeling shall appear on such article of labeling.



Sec. 501.17  Animal food labeling warning statements.

    (a) Self-pressurized containers. (1) The label of a food packaged in 
a self-pressurized container and intended to be expelled from the 
package under pressure shall bear the following warning:
    Warning Avoid spraying in eyes. Contents under pressure. Do not 
puncture or incinerate. Do not store at temperature above 120 [deg]F. 
Keep out of reach of children.
    (2) In the case of products intended for use by children, the phrase 
``except under adult supervision'' may be added at the end of the last 
sentence in the warning required by paragraph (a)(1) of this section.
    (3) In the case of products packaged in glass containers, the word 
``break'' may be substituted for the word ``puncture'' in the warning 
required by paragraph (a)(1) of this section.
    (4) The words ``Avoid spraying in eyes'' may be deleted from the 
warning required by paragraph (a)(1) of this section in the case of a 
product not expelled as a spray.
    (b) Self-pressurized containers with halocarbon or hydrocarbon 
propellants. (1) In addition to the warning required by paragraph (a) of 
this section, the label of a food packaged in a self-pressurized 
container in which the propellant consists in whole or in part of a 
halocarbon or a hydrocarbon shall bear the following warning:
    Warning Use only as directed. Intentional misuse by deliberately 
concentrating and inhaling the contents can be harmful or fatal.
    (2) The warning required by paragraph (b)(1) of this section is not 
required for the following products:
    (i) Products expelled in the form of a foam or cream, which contain 
less than 10 percent propellant in the container.
    (ii) Products in a container with a physical barrier that prevents 
escape of the propellant at the time of use.
    (iii) Products of a net quantity of contents of less than 2 ozs that 
are designed to release a measured amount of product with each valve 
actuation.
    (iv) Products of a net quantity of contents of less than \1/2\ oz.
    (c) Animal food containing or manufactured with a chlorofluorocarbon 
or other ozone-depleting substance. Labeling requirements for animal 
foods that contain or are manufactured with a chlorofluorocarbon or 
other ozone-depleting substance designated by the Environmental 
Protection Agency (EPA) are set forth in 40 CFR part 82.

[41 FR 38619, Sept. 10, 1976, as amended at 42 FR 22033, Apr. 29, 1977; 
61 FR 20101, May 3, 1996]



Sec. 501.18  Misbranding of animal food.

    (a) Among representations in the labeling of a food which render 
such food misbranded is a false or misleading representation with 
respect to another food or a drug, device, or cosmetic.
    (b) The labeling of a food which contains two or more ingredients 
may be misleading by reason (among other reasons) of the designation of 
such food in such labeling by a name which includes or suggests the name 
of one or more but not all such ingredients, even though the names of 
all such ingredients are stated elsewhere in the labeling.
    (c) Among representations in the labeling of a food which render 
such food misbranded is any representation that expresses or implies a 
geographical origin of the food or any ingredient of the food except 
when such representation is either:
    (1) A truthful representation of geographical origin.
    (2) A trademark or trade name provided that as applied to the 
article in question its use is not deceptively misdescriptive. A 
trademark or trade name comprised in whole or in part of

[[Page 22]]

geographical words shall not be considered deceptively misdescriptive if 
it:
    (i) Has been so long and exclusively used by a manufacturer or 
distributor that it is generally understood by the consumer to mean the 
product of a particular manufacturer or distributor; or
    (ii) Is so arbitrary or fanciful that it is not generally understood 
by the consumer to suggest geographic origin.
    (3) A part of the name required by applicable Federal law or 
regulation.
    (4) A name whose market significance is generally understood by the 
consumer to connote a particular class, kind, type, or style of food 
rather than to indicate geographical origin.



          Subpart B_Specific Animal Food Labeling Requirements



Sec. 501.22  Animal foods; labeling of spices, flavorings, colorings,
and chemical preservatives.

    (a)(1) The term artificial flavor or artificial flavoring means any 
substance, the function of which is to impart flavor, which is not 
derived from a spice, fruit or fruit juice, vegetable or vegetable 
juice, edible yeast, herb, bark, bud, root, leaf or similar plant 
material, meat, fish, poultry, eggs, dairy products, or fermentation 
products thereof. Artificial flavor includes the substances listed in 
Sec. Sec. 172.515(b) and 582.60 of this chapter except where these are 
derived from natural sources.
    (2) The term spice means any aromatic vegetable substance in the 
whole, broken, or ground form, except for those substances which have 
been traditionally regarded as foods, such as onions, garlic and celery; 
whose significant function in food is seasoning rather than nutritional; 
that is true to name; and from which no portion of any volatile oil or 
other flavoring principle has been removed. Spices include the spices 
listed in subpart A of part 582 of this chapter, such as the following:

Allspice, Anise, Basil, Bay leaves, Caraway seed, Cardamon, Celery seed, 
Chervil, Cinnamon, Cloves, Coriander, Cumin seed, Dill seed, Fennel 
seed, Fenugreek, Ginger, Horseradish, Mace, Marjoram, Mustard flour, 
Nutmeg, Oregano, Paprika, Parsley, Pepper, black; Pepper, white; Pepper, 
red; Rosemary, Saffron, Sage, Savory, Star aniseed, Tarragon, Thyme, 
Turmeric.


Paprika, turmeric, and saffron or other spices which are also colors, 
shall be declared as spice and coloring unless declared by their common 
or usual name.
    (3) The term natural flavor or natural flavoring means the essential 
oil, oleoresin, essence or extractive, protein hydrolysate, distillate, 
or any product of roasting, heating or enzymolysis, which contains the 
flavoring constituents derived from a spice, fruit or fruit juice, 
vegetable or vegetable juice, edible yeast, herb, bark, bud, root, leaf 
or similar plant material, meat, seafood, poultry, eggs, dairy products, 
or fermentation products thereof, whose significant function in food is 
flavoring rather than nutritional. Natural flavors, include the natural 
essence or extractives obtained from plants listed in subpart A of part 
582 of this chapter, and the substances listed in Sec. 172.510 of this 
chapter.
    (4) The term artificial color or artificial coloring means any color 
additive as defined in Sec. 70.3(f) of this chapter.
    (5) The term chemical preservative means any chemical that, when 
added to food, tends to prevent or retard deterioration thereof, but 
does not include common salt, sugars, vinegars, spices, or oils 
extracted from spices, substances added to food by direct exposure 
thereof to wood smoke, or chemicals applied for their insecticidal or 
herbicidal properties.
    (b) A food which is subject to the requirements of section 403(k) of 
the act shall bear labeling, even though such food is not in package 
form.
    (c) A statement of artificial flavoring, artificial coloring, or 
chemical preservative shall be placed on the food, or on its container 
or wrapper, or on any two or all of these, as may be necessary to render 
such statement likely to be read by the ordinary individual under 
customary conditions of purchase and use of such food.
    (d) A food shall be exempt from compliance with the requirements of 
section 403(k) of the act if it is not in package form and the units 
thereof are so small that a statement of artificial flavoring, 
artificial coloring, or chemical preservative, as the case may be, 
cannot be placed on such units with

[[Page 23]]

such conspicuousness as to render it likely to be read by the ordinary 
individual under customary conditions of purchase and use.
    (e) A food shall be exempt while held for sale from the requirements 
of section 403(k) of the act (requiring label statement of any 
artificial flavoring, artificial coloring, or chemical preservatives) if 
said food, having been received in bulk containers at a retail 
establishment, is displayed to the purchaser with either (1) the 
labeling of the bulk container plainly in view or (2) a counter card, 
sign, or other appropriate device bearing prominently and conspicuously 
the information required to be stated on the label pursuant to section 
403(k) of the act.
    (f) A fruit or vegetable shall be exempt from compliance with the 
requirements of section 403(k) of the act with respect to a chemical 
preservative applied to the fruit or vegetable as a pesticide chemical 
prior to harvest.
    (g) A flavor shall be labeled in the following way when shipped to a 
food manufacturer or processor (but not a consumer) for use in the 
manufacture of a fabricated food, unless it is a flavor for which a 
standard of identity has been promulgated, in which case it shall be 
labeled as provided in the standard:
    (1) If the flavor consists of one ingredient, it shall be declared 
by its common or usual name.
    (2) If the flavor consists of two or more ingredients, the label 
either may declare each ingredient by its common or usual name or may 
state ``All flavor ingredients contained in this product are approved 
for use in a regulation of the Food and Drug Administration.'' Any 
flavor ingredient not contained in one of these regulations, and any 
nonflavor ingredient, shall be separately listed on the label.
    (3) In cases where the flavor contains a solely natural flavor(s), 
the flavor shall be so labeled, e.g., strawberry flavor, banana flavor, 
or natural strawberry flavor. In cases where the flavor contains both a 
natural flavor and an artificial flavor, the flavor shall be so labeled, 
e.g., natural and artificial strawberry flavor. In cases where the 
flavor contains a solely artificial flavor(s), the flavor shall be so 
labeled, e.g., artificial strawberry flavor.
    (h) The label of a food to which flavor is added shall declare the 
flavor in the statement of ingredients in the following way:
    (1) Spice, natural flavor, and artificial flavor may be declared as 
spice, natural flavor, or artificial flavor, or any combination thereof, 
as the case may be.
    (2) An incidental additive in a food, originating in a spice or 
flavor used in the manufacture of the food, need not be declared in the 
statement of ingredients if it meets the requirements of Sec. 
501.100(a)(3).
    (3) Substances obtained by cutting, grinding, drying, pulping, or 
similar processing of tissues derived from fruit, vegetable, meat, fish, 
or poultry, e.g., powdered or granulated onions, garlic powder, and 
celery powder, are commonly understood by consumers to be food rather 
than flavor and shall be declared by their common or usual name.
    (4) Any salt (sodium chloride) used as an ingredient in food shall 
be declared by its common or usual name salt.
    (5) Any monosodium glutamate used as an ingredient in food shall be 
declared by its common or usual name monosodium glutamate.
    (6) Any pyroligneous acid or other artificial smoke flavors used as 
an ingredient in a food may be declared as artificial flavor or 
artificial smoke flavor. No representation may be made, either directly 
or implied, that a food flavored with pyroligneous acid or other 
artificial smoke flavor has been smoked or has a true smoked flavor, or 
that a seasoning sauce or similar product containing pyroligneous acid 
or other artificial smoke flavor and used to season or flavor other 
foods will result in a smoked product or one having a true smoked 
flavor.
    (i) If the label, labeling, or advertising of a food makes any 
direct or indirect representations with respect to the primary 
recognizable flavor(s), by word, vignette, e.g., depiction of a fruit, 
or other means, or if for any other reason the manufacturer or 
distributor of a food wishes to designate the type of flavor in the food 
other than through

[[Page 24]]

the statement of ingredients, such flavor shall be considered the 
characterizing flavor and shall be declared in the following way:
    (1) If the food contains no artificial flavor which simulates, 
resembles or reinforces the characterizing flavor, the name of the food 
on the principal display panel or panels of the label shall be 
accompanied by the common or usual name of the characterizing flavor in 
letters not less than one-half the height of the letters used in the 
name of the food, except that:
    (i) If the food is one that is commonly expected to contain a 
characterizing food ingredient, and the food contains natural flavor 
derived from such ingredient and an amount of characterizing ingredient 
insufficient to independently characterize the food, or the food 
contains no such ingredient, the name of the characterizing flavor may 
be immediately preceded by the word natural and shall be immediately 
followed by the word flavored in letters not less than one-half the 
height of the letters in the name of the characterizing flavor.
    (ii) If none of the natural flavor used in the food is derived from 
the product whose flavor is simulated, the food in which the flavor is 
used shall be labeled either with the flavor of the product from which 
the flavor is derived or as artificially flavored.
    (iii) If the food contains both a characterizing flavor from the 
product whose flavor is simulated and other natural flavor which 
simulates, resembles or reinforces the characterizing flavor, the food 
shall be labeled in accordance with the introductory text and paragraph 
(i)(1)(i) of this section and the name of the food shall be immediately 
followed by the words with other natural flavor in letters not less than 
one-half the height of the letters used in the name of the 
characterizing flavor.
    (2) If the food contains any artificial flavor which simulates, 
resembles or reinforces the characterizing flavor, the name of the food 
on the principal display panel or panels of the label shall be 
accompanied by the common or usual name(s) of the characterizing flavor, 
in letters not less than one-half the height of the letters used in the 
name of the food and the name of the characterizing flavor shall be 
accompanied by the word(s) artificial or artificially flavored, in 
letters not less than one-half the height of the letters in the name of 
the characterizing flavor.
    (3) Wherever the name of the characterizing flavor appears on the 
label (other than in the statement of ingredients) so conspicuously as 
to be easily seen under customary conditions of purchase, the words 
prescribed by this paragraph shall immediately and conspicuously precede 
or follow such name, without any intervening written, printed, or 
graphic matter, except:
    (i) Where the characterizing flavor and a trademark or brand are 
presented together, other written, printed, or graphic matter that is a 
part of or is associated with the trademark or brand may intervene if 
the required words are in such relationship with the trademark or brand 
as to be clearly related to the characterizing flavor; and
    (ii) If the finished product contains more than one flavor subject 
to the requirements of this paragraph, the statements required by this 
paragraph need appear only once in each statement of characterizing 
flavors present in such food.
    (iii) If the finished product contains three or more distinguishable 
characterizing flavors, or a blend of flavors with no primary 
recognizable flavor, the flavor may be declared by an appropriately 
descriptive generic term in lieu of naming each flavor.
    (4) A flavor supplier shall certify, in writing, that any flavor he 
supplies which is designated as containing no artificial flavor does 
not, to the best of his knowledge and belief, contain any artificial 
flavor, and that he has added no artificial flavor to it. The 
requirement for such certification may be satisfied by a guarantee under 
section 303(c)(2) of the act which contains such a specific statement. A 
flavor used shall be required to make such a written certification only 
where he adds to or combines another flavor with a flavor which has been 
certified by a flavor supplier as containing no artificial flavor, but 
otherwise such user may rely upon the supplier's certification and need 
make no separate certification.

[[Page 25]]

All such certifications shall be retained by the certifying party 
throughout the period in which the flavor is supplied and for a minimum 
of 3 years thereafter, and shall be subject to the following conditions:
    (i) The certifying party shall make such certifications available 
upon request at all reasonable hours to any duly authorized officer, or 
employee of the Food and Drug Administration or any other employee 
acting on behalf of the Secretary of Health and Human Services. Such 
certifications are regarded by the Food and Drug Administration as 
reports to the government and as guarantees or other undertakings within 
the meaning of section 301(h) of the act and subject the certifying 
party to the penalties for making any false report to the government 
under 18 U.S.C. 1001 and any false guarantee or undertaking under 
section 303(a) of the act. The defenses provided under section 303(c)(2) 
of the act shall be applicable to the certifications provided for in 
this section.
    (ii) Wherever possible, the Food and Drug Administration shall 
verify the accuracy of a reasonable number of certifications made 
pursuant to this section, constituting a representative sample of such 
certifications, and shall not request all such certifications.
    (iii) Where no person authorized to provide such information is 
reasonably available at the time of inspection, the certifying party 
shall arrange to have such person and the relevant materials and records 
ready for verification as soon as practicable; provided that, whenever 
the Food and Drug Administration has reason to believe that the supplier 
or user may utilize this period to alter inventories or records, such 
additional time shall not be permitted. Where such additional time is 
provided, the Food and Drug Administration may require the certifying 
party to certify that relevant inventories have not been materially 
disturbed and relevant records have not been altered or concealed during 
such period.
    (iv) The certifying party shall provide, to an officer or 
representative duly designated by the Secretary, such qualitative 
statement of the composition of the flavor or product covered by the 
certification as may be reasonably expected to enable the Secretary's 
representatives to determine which relevant raw and finished materials 
and flavor ingredient records are reasonably necessary to verify the 
certifications. The examination conducted by the Secretary's 
representative shall be limited to inspection and review of inventories 
and ingredient records for those certifications which are to be 
verified.
    (v) Review of flavor ingredient records shall be limited to the 
qualitative formula and shall not include the quantitative formula. The 
person verifying the certifications may make only such notes as are 
necessary to enable him to verify such certification. Only such notes or 
such flavor ingredient records as are necessary to verify such 
certification or to show a potential or actual violation may be removed 
or transmitted from the certifying party's place of business: Provided, 
That, where such removal or transmittal is necessary for such purposes 
the relevant records and notes shall be retained as separate documents 
in Food and Drug Administration files, shall not be copied in other 
reports, and shall not be disclosed publicly other than in a judicial 
proceeding brought pursuant to the act or 18 U.S.C. 1001.
    (j) A food to which a chemical preservative(s) is added shall, 
except when exempt pursuant to Sec. 501.100, bear a label declaration 
stating both the common or usual name of the ingredient(s) and a 
separate description of its function, e.g., preservative, to retard 
spoilage, a mold inhibitor, to help protect flavor or to promote color 
retention.
    (k) The label of an animal food to which any coloring has been added 
shall declare the coloring in the statement of ingredients in the manner 
specified in paragraphs (k)(1) and (k)(2) of this section.
    (1) A color additive or the lake of a color additive subject to 
certification under section 721(c) of the act shall be declared by the 
name of the color additive listed in the applicable regulation in part 
74 or part 82 of this chapter, except that it is not necessary to 
include the ``FD&C'' prefix or the term ``No.'' in the declaration, but 
the term

[[Page 26]]

``Lake'' shall be included in the declaration of the lake of the 
certified color additive (e.g., Blue 1 Lake). Manufacturers may 
parenthetically declare an appropriate alternative name of the certified 
color additive following its common or usual name as specified in part 
74 or part 82 of this chapter.
    (2) Color additives not subject to certification may be declared as 
``Artificial Color,'' ``Artificial Color Added,'' or ``Color Added'' (or 
by an equally informative term that makes clear that a color additive 
has been used in the food). Alternatively, such color additives may be 
declared as ``Colored with ____'' or ``____ color,'' the blank to be 
filled with the name of the color additive listed in the applicable 
regulation in part 73 of this chapter.

[41 FR 38619, Sept. 10, 1976, as amended at 42 FR 14091, Mar. 15, 1977; 
42 FR 15675, Mar. 22, 1977; 76 FR 71254, Nov. 17, 2011]

Subparts C-E [Reserved]



       Subpart F_Exemptions From Animal Food Labeling Requirements



Sec. 501.100  Animal food; exemptions from labeling.

    (a) The following foods are exempt from compliance with the 
requirements of section 403(i)(2) of the act (requiring a declaration on 
the label of the common or usual name of each ingredient when the food 
is fabricated from two or more ingredients).
    (1) An assortment of different items of food, when variations in the 
items that make up different packages packed from such assortment 
normally occur in good packing practice and when such variations result 
in variations in the ingredients in different packages, with respect to 
any ingredient that is not common to all packages. Such exemption, 
however, shall be on the condition that the label shall bear, in 
conjunction with the names of such ingredients as are common to all 
packages, a statement (in terms that are as informative as practicable 
and that are not misleading) indicating by name other ingredients which 
may be present.
    (2) A food having been received in bulk containers at a retail 
establishment, if displayed to the purchaser with either (i) the 
labeling of the bulk container plainly in view or (ii) a counter card, 
sign, or other appropriate device bearing prominently and conspicuously 
the information required to be stated on the label pursuant to section 
403(i)(2) of the act.
    (3) Incidental additives that are present in a food at insignificant 
levels and do not have any technical or functional effect in that food. 
For the purposes of this paragraph (a)(3), incidental additives are:
    (i) Substances that have no technical or functional effect but are 
present in a food by reason of having been incorporated into the food as 
an ingredient of another food, in which the substance did have a 
functional or technical effect.
    (ii) Processing aids, which are as follows:
    (a) Substances that are added to a food during the processing of 
such food but are removed in some manner from the food before it is 
packaged in its finished form.
    (b) Substances that are added to a food during processing, are 
converted into constituents normally present in the food, and do not 
significantly increase the amount of the constituents naturally found in 
the food.
    (c) Substances that are added to a food for their technical or 
functional effect in the processing but are present in the finished food 
at insignificant levels and do not have any technical or functional 
effect in that food.
    (iii) Substances migrating to food from equipment or packaging or 
otherwise affecting food that are not food additives as defined in 
section 201(s) of the act; or if they are food additives as so defined, 
they are used in conformity with regulations established pursuant to 
section 409 of the act.
    (b) A food repackaged in a retail establishment is exempt from the 
following provisions of the act if the conditions specified are met.
    (1) Section 403(e)(1) of the act (requiring a statement on the label 
of the name and place of business of the manufacturer, packer, or 
distributor).

[[Page 27]]

    (2) Section 403(g)(2) of the act (requiring the label of a food 
which purports to be or is represented as one for which a definition and 
standard of identity has been prescribed to bear the name of the food 
specified in the definition and standard and, insofar as may be required 
by the regulation establishing the standard the common names of the 
optional ingredients present in the food), if the food is displayed to 
the purchaser with its interstate labeling clearly in view, or with a 
counter card, sign, or other appropriate device bearing prominently and 
conspicuously the information required by these provisions.
    (3) Section 403(i)(1) of the act (requiring the label to bear the 
common or usual name of the food), if the food is displayed to the 
purchaser with its interstate labeling clearly in view, or with a 
counter card, sign, or other appropriate device bearing prominently and 
conspicuously the common or usual name of the food, or if the common or 
usual name of the food is clearly revealed by its appearance.
    (c) [Reserved]
    (d) Except as provided by paragraphs (e) and (f) of this section, a 
shipment or other delivery of a food which is, in accordance with the 
practice of the trade, to be processed, labeled, or repacked in 
substantial quantity at an establishment other than that where 
originally processed or packed, shall be exempt, during the time of 
introduction into and movement in interstate commerce and the time of 
holding in such establishment, from compliance with the labeling 
requirements of section 403 (c), (e), (g), (h), (i), (j) and (k) of the 
act if:
    (1) The person who introduced such shipment or delivery into 
interstate commerce is the operator of the establishment where such food 
is to be processed, labeled, or repacked; or
    (2) In case such person is not such operator, such shipment or 
delivery is made to such establishment under a written agreement, signed 
by and containing the post office addresses of such person and such 
operator, and containing such specifications for the processing, 
labeling, or repacking, as the case may be, of such food in such 
establishment as will ensure, if such specifications are followed, that 
such food will not be adulterated or misbranded within the meaning of 
the act upon completion of such processing, labeling, or repacking. Such 
person and such operator shall each keep a copy of such agreement until 
2 years after the final shipment or delivery of such food from such 
establishment, and shall make such copies available for inspection at 
any reasonable hour to any officer or employee of the Department who 
requests them.
    (e) Conditions affecting expiration of exemptions.
    (1) An exemption of a shipment or other delivery of a food under 
paragraph (d)(1) of this section shall, at the beginning of the act of 
removing such shipment or delivery, or any part thereof, from such 
establishment become void ab initio if the food comprising such 
shipment, delivery, or part is adulterated or misbranded within the 
meaning of the act when so removed.
    (2) An exemption of a shipment or other delivery of a food under 
paragraph (d)(2) of this section shall become void ab initio with 
respect to the person who introduced such shipment or delivery into 
interstate commerce upon refusal by such person to make available for 
inspection a copy of the agreement, as required by paragraph (d)(2) of 
this section.
    (3) An exemption of a shipment or other delivery of a food under 
paragraph (d)(2) of this section shall expire:
    (i) At the beginning of the act of removing such shipment or 
delivery, or any part thereof, from such establishment if the food 
comprising such shipment, delivery, or part is adulterated or misbranded 
within the meaning of the act when so removed; or
    (ii) Upon refusal by the operator of the establishment where such 
food is to be processed, labeled, or repacked, to make available for 
inspection a copy of the agreement as required by such paragraph.
    (f) [Reserved]
    (g) The label declaration of a harmless marker used to identify a 
particular manufacturer's product may result in unfair competition 
through revealing a trade secret. Exemption from the label declaration 
of such a marker

[[Page 28]]

is granted, therefore, provided that the following conditions are met:
    (1) The person desiring to use the marker without label declaration 
of its presence has submitted to the Commissioner of Food and Drugs full 
information concerning the proposed usage and the reasons why he 
believes label declaration of the marker should be subject to this 
exemption; and
    (2) The person requesting the exemption has received from the 
Commissioner of Food and Drugs a finding that the marker is harmless and 
that the exemption has been granted.



Sec. 501.103  Petitions requesting exemptions from or special
requirements for label declaration of ingredients.

    The Commissioner of Food and Drugs, either on his own initiative or 
on behalf of any interested person who has submitted a petition pursuant 
to part 10 of this chapter may issue a proposal to amend Sec. 501.4 to 
specify the manner in which an ingredient(s) shall be declared, i.e., by 
specific or class name, or Sec. 501.100 to exempt an ingredient(s) from 
the requirements for label declaration.

[41 FR 38619, Sept. 10, 1976, as amended at 42 FR 15675, Mar. 22, 1977]



Sec. 501.105  Declaration of net quantity of contents when exempt.

    (a) The principal display panel of a food in package form shall bear 
a declaration of the net quantity of contents. This shall be expressed 
in the terms of weight, measure, numerical count, or a combination of 
numerical count and weight or measure. The statement shall be in terms 
of fluid measure if the food is liquid, or in terms of weight if the 
food is solid, semisolid, or viscous, or a mixture of solid and liquid; 
except that such statement may be in terms of dry measure if the food is 
a fresh fruit, fresh vegetable, or other dry commodity that is 
customarily sold by dry measure. If there is a firmly established 
general consumer usage and trade custom of declaring the contents of a 
liquid by weight, or a solid, semisolid, or viscous product by fluid 
measure, it may be used. Whenever the Commissioner determines that an 
existing practice of declaring net quantity of contents by weight, 
measure, numerical count, or a combination in the case of a specific 
packaged food does not facilitate value comparisons by consumers and 
offers opportunity for consumer confusion, he will by regulation 
designate the appropriate term or terms to be used for such commodity.
    (b)(1) Statements of weight shall be in terms of avoirdupois pound 
and ounce.
    (2) Statements of fluid measure shall be in terms of the U.S. gallon 
of 231 cubic inches and quart, pint, and fluid ounce subdivisions 
thereof, and shall:
    (i) In the case of frozen food that is sold and consumed in a frozen 
state, express the volume at the frozen temperature.
    (ii) In the case of refrigerated food that is sold in the 
refrigerated state, express the volume at 40 [deg]F (4 [deg]C).
    (iii) In the case of other foods, express the volume at 68 [deg]F 
(20 [deg]C).
    (3) Statements of dry measure shall be in terms of the U.S. bushel 
of 2,150.42 cubic inches and peck, dry quart, and dry pint subdivisions 
thereof.
    (c) When the declaration of quantity of contents by numerical count 
does not give adequate information as to the quantity of food in the 
package, it shall be combined with such statement of weight, measure, or 
size of the individual units of the foods as will provide such 
information.
    (d) The declaration may contain common or decimal fractions. A 
common fraction shall be in terms of halves, quarters, eighths, 
sixteenths, or thirty-seconds; except that if there exists a firmly 
established general consumer usage and trade custom of employing 
different common fractions in the net quantity declaration of a 
particular commodity, they may be employed. A common fraction shall be 
reduced to its lowest terms; a decimal fraction shall not be carried out 
to more than two places. A statement that includes small fractions of an 
ounce shall be deemed to permit smaller variations than one which does 
not include such fractions.
    (e) The declaration shall be located on the principal display panel 
of the label, and with respect to packages bearing alternate principal 
panels it

[[Page 29]]

shall be duplicated on each principal display panel.
    (f) The declaration shall appear as a distinct item on the principal 
display panel, shall be separated (by at least a space equal to the 
height of the lettering used in the declaration) from other printed 
label information appearing above or below the declaration and (by at 
least a space equal to twice the width of the letter ``N'' of the style 
of type used in the quantity of contents statement) from other printed 
label information appearing to the left or right of the declaration. It 
shall not include any term qualifying a unit of weight, measure, or 
count (such as jumbo quart and full gallon) that tends to exaggerate the 
amount of the food in the container. It shall be placed on the principal 
display panel within the bottom 30 percent of the area of the label 
panel in lines generally parallel to the base on which the package rests 
as it is designed to be displayed: Provided, That on packages having a 
principal display panel of 5 square inches or less, the requirement for 
placement within the bottom 30 percent of the area of the label panel 
shall not apply when the declaration of net quantity of contents meets 
the other requirements of this part.
    (g) The declaration shall accurately reveal the quantity of food in 
the package exclusive of wrappers and other material packed therewith; 
provided that in the case of foods packed in containers designed to 
deliver the food under pressure, the declaration shall state the net 
quantity of the contents that will be expelled when the instructions for 
use as shown on the container are followed. The propellant is included 
in the net quantity declaration.
    (h) The declaration shall appear in conspicuous and easily legible 
boldface print or type in distinct contrast (by typography, layout, 
color, embossing, or molding) to other matter on the package; except 
that a declaration of net quantity blown, embossed, or molded on a glass 
or plastic surface is permissible when all label information is so 
formed on the surface. Requirements of conspicuousness and legibility 
shall include the specifications that:
    (1) The ratio of height to width (of the letter) shall not exceed a 
differential of 3 units to 1 unit (no more than 3 times as high as it is 
wide).
    (2) Letter heights pertain to upper case or capital letters. When 
upper and lower case or all lower case letters are used, it is the lower 
case letter ``o'' or its equivalent that shall meet the minimum 
standards.
    (3) When fractions are used, each component numeral shall meet one-
half the minimum height standards.
    (i) The declaration shall be in letters and numerals in a type size 
established in relationship to the area of the principal display panel 
of the package and shall be uniform for all packages of substantially 
the same size by complying with the following type specifications:
    (1) Not less than \1/16\ inch in height on packages the principal 
display panel of which has an area of 5 square inches or less.
    (2) Not less than \1/8\ inch in height on packages the principal 
display panel of which has an area of more than 5 but not more than 25 
square inches.
    (3) Not less than \3/16\ inch in height on packages the principal 
display panel of which has an area of more than 25 but not more than 100 
square inches.
    (4) Not less than \1/4\ inch in height on packages the principal 
display panel of which has an area of more than 100 square inches, 
except not less than \1/2\ inch in height if the area is more than 400 
square inches.


Where the declaration is blown, embossed, or molded on a glass or 
plastic surface rather than by printing, typing, or coloring, the 
lettering sizes specified in paragraphs (i) (1) through (4) of this 
section shall be increased by \1/16\ of an inch.
    (j) On packages containing less than 4 pounds or 1 gallon and 
labeled in terms of weight or fluid measure:
    (1) The declaration shall be expressed both in ounces, with 
identification by weight or by liquid measure and, if applicable (1 
pound or 1 pint or more) followed in parentheses by a declaration in 
pounds for weight units, with any remainder in terms of ounces or common 
or decimal fractions of the pound (see examples set forth in paragraphs 
(m) (1) and (2) of this section), or in the case of liquid measure, in 
the largest whole units (quarts, quarts and pints,

[[Page 30]]

or pints, as appropriate) with any remainder in terms of fluid ounces or 
common or decimal fractions of the pint or quart (see examples in 
paragraphs (m) (3) and (4) of this section).
    (2) If the net quantity of contents declaration appears on a random 
package, that is a package which is one of a lot, shipment, or delivery 
of packages of the same consumer commodity with varying weights and with 
no fixed weight pattern, it may, when the net weight exceeds 1 pound, be 
expressed in terms of pounds and decimal fractions of the pound carried 
out to not more than two decimal places. When the net weight does not 
exceed 1 pound, the declaration on the random package may be in decimal 
fractions of the pound in lieu of ounces (see example in paragraph 
(m)(5) of this section).
    (3) The declaration may appear in more than one line. The term net 
weight shall be used when stating the net quantity of contents in terms 
of weight. Use of the terms net or net contents in terms of fluid 
measure or numerical count is optional. It is sufficient to distinguish 
avoirdupois ounce from fluid ounce through association of terms; for 
example, Net wt. 6 oz. or 6 oz. net wt. and 6 fl. oz. or net contents 6 
fl. oz.
    (k) On packages containing 4 pounds or 1 gallon or more and labeled 
in terms of weight or fluid measure, the declaration shall be expressed 
in pounds for weight units with any remainder in terms of ounces or 
common or decimal fraction of the pound, or in the case of fluid 
measure, it shall be expressed in the largest whole unit (gallons 
followed by common or decimal fraction of a gallon or by the next 
smaller whole unit or units (quarts, or quarts and pints)) with any 
remainder in terms of fluid ounces or common or decimal fractions of the 
pint or quart (see paragraph (m)(6) of this section).
    (l) [Reserved]
    (m) Examples: (1) A declaration of 1\1/2\ pounds weight shall be 
expressed as Net Wt. 24 oz. (1 lb. 8 oz.), Net Wt. 24 oz. (1\1/2\ lb.), 
or Net Wt. 24 oz. (1.5 lb.).
    (2) A declaration of \3/4\ pound avoirdupois weight shall be 
expressed as Net Wt. 12 oz.
    (3) A declaration of 1 quart liquid measure shall be expressed as 
Net 32 fl. oz. (1 qt.).
    (4) A declaration of 1\3/4\ quarts liquid measure shall be expressed 
as Net contents 56 fluid ounces (1 quart 1\1/2\ pints) or as Net 56 
fluid oz. (1 qt. 1 pt. 8 oz.), but not in terms of quart and ounce such 
as Net 56 fluid oz. (1 quart 24 ounces).
    (5) On a random package, declaration of \3/4\ pound avoirdupois may 
be expressed as Net Wt. .75 lb.
    (6) A declaration of 2\1/2\ gallons liquid measure shall be 
expressed as Net contents 2\1/2\ gallons, Net contents 2.5 gallons, or 
Net contents 2 gallons 2 quarts and not as 2 gallons 4 pints.
    (n) For quantities, the following abbreviations and none other may 
be employed (periods and plural forms are optional):

weight wt.
ounce oz.
pound lb.
gallon gal.
pint pt.
quart qt.
fluid fl.

    (o) Nothing in this section shall prohibit supplemental statements 
at locations other than the principal display panel(s) describing in 
nondeceptive terms the net quantity of contents; provided, that such 
supplemental statements of net quantity of contents shall not include 
any term qualifying a unit of weight, measure, or count that tends to 
exaggerate the amount of the food contained in the package; for example, 
jumbo quart and full gallon. Dual or combination declarations of net 
quantity of contents as provided for in paragraphs (a), (c), and (j) of 
this section (for example, a combination of net weight plus numerical 
count, net contents plus dilution directions of a concentrate, etc.) are 
not regarded as supplemental net quantity statements and may be located 
on the principal display panel.
    (p) A separate statement of the net quantity of contents in terms of 
the metric system is not regarded as a supplemental statement and an 
accurate statement of the net quantity of contents in terms of the 
metric system of weight or measure may also appear on the principal 
display panel or on other panels.
    (q) The declaration of net quantity of contents shall express an 
accurate statement of the quantity of contents

[[Page 31]]

of the package. Reasonable variations caused by loss or gain of moisture 
during the course of good distribution practice or by unavoidable 
deviations in good manufacturing practice will be recognized. Variations 
from stated quantity of contents shall not be unreasonably large.
    (r) [Reserved]
    (s) On a multiunit retail package, a statement of the quantity of 
contents shall appear on the outside of the package and shall include 
the number of individual units, the quantity of each individual unit, 
and, in parentheses, the total quantity of contents of the multiunit 
package in terms of avoirdupois or fluid ounces, except that such 
declaration of total quantity need not be followed by an additional 
parenthetical declaration in terms of the largest whole units and 
subdivisions thereof, as required by paragraph (j)(1) of this section. A 
multiunit retail package may thus be properly labeled: 6-16 oz. 
bottles--(96 fl. oz.) or 3-16 oz. cans--(net wt. 48 oz). For the 
purposes of this section, multiunit retail package means a package 
containing two or more individually packaged units of the identical 
commodity and in the same quantity, intended to be sold as part of the 
multiunit retail package but capable of being individually sold in full 
compliance with all requirements of the regulations in this part. Open 
multiunit retail packages that do not obscure the number of units nor 
prevent examination of the labeling on each of the individual units are 
not subject to this paragraph if the labeling of each individual unit 
complies with the requirements of paragraphs (f) and (i) of this 
section.
    (t) Where the declaration of net quantity of contents is in terms of 
net weight and/or drained weight or volume and does not accurately 
reflect the actual quantity of the contents or the product falls below 
the applicable standard of fill of container because of equipment 
malfunction or otherwise unintentional product variation, and the label 
conforms in all other respects to the requirements of this chapter, the 
mislabeled food product may be sold by the manufacturer or processor 
directly to institutions operated by Federal, State or local 
governments: Provided, That:
    (1) The purchaser shall sign a statement at the time of sale stating 
that he is aware that the product is mislabeled to include 
acknowledgement of the nature and extent of the mislabeling, e.g., 
``Actual net weight may be as low as __% below labeled quantity'' and 
that any subsequent distribution by him of said product except for his 
own institutional use is unlawful. This statement shall be kept on file 
at the principal place of business of the manufacturer or processor for 
2 years subsequent to the date of shipment of the product and shall be 
available to the Food and Drug Administration upon request.
    (2) The product shall be labeled on the outside of its shipping 
container with the statement(s):
    (i) When the variation concerns net weight and/or drained weight of 
volume--``Product Mislabeled. Actual net weight (drained weight or 
volume where appropriate) may be as low as __% below labeled quantity. 
This Product Not for Retail Distribution,'' the blank to be filled in 
with the maximum percentage variance between the labeled and actual 
weight or volume of contents of the individual packages in the shipping 
container, and
    (ii) When the variation is in regard to a fill of container 
standard--``Product Mislabeled. Actual fill may be as low as __% below 
standard of fill. This Product Not for Retail Distribution.''
    (3) The statements required by paragraphs (t)(2) (i) and (ii) of 
this section, which may be consolidated where appropriate, shall appear 
prominently and conspicuously as compared to other printed matter on the 
shipping container and in boldface print or type on a clear, contrasting 
background in order to render them likely to be read and understood by 
the purchaser under ordinary conditions of purchase.

[41 FR 38619, Sept. 10, 1976, as amended at 54 FR 18279, Apr. 28, 1989; 
85 FR 72908, Nov. 16, 2020]



Sec. 501.110  Animal feed labeling; collective names for feed 
ingredients.

    (a) An animal feed shall be exempt from the requirements of section 
403(i)(2) of the act with respect to its

[[Page 32]]

label bearing the common or usual names of the animal feed ingredients 
listed in paragraph (b) of this section under the following prescribed 
conditions:
    (1) The animal feed is intended solely for livestock and poultry.
    (2) The label of the animal feed bears the collective name(s) 
prescribed in paragraph (b) of this section in lieu of the corresponding 
common or usual names of the individual feed ingredients contained 
therein.
    (3) The label of the animal feed otherwise conforms to the 
requirements of section 403(i)(2) of the act.
    (4) The ingredients of any feed listed in paragraph (b) of this 
section neither contain nor are food additives as defined in section 
201(s) of the act unless provided for by and in conformity with 
applicable regulations established pursuant to section 409 of the act.
    (b) Each collective name referred to in this paragraph may be used 
for the purpose of labeling where one or more of the ingredients listed 
for that collective name are present. The animal feed ingredients listed 
under each of the collective names are the products defined by the 
Association of American Feed Control Officials. The collective names are 
as follows:
    (1) Animal protein products include one or more of the following: 
Animal products, marine products, and milk products.
    (2) Forage products include one or more of the following: Alfalfa 
meals, entire plant meals, hays, and stem meals.
    (3) Grain products include one or more of the following: Barley, 
grain sorghums, maize (corn), oats, rice, rye, and wheat.
    (4) Plant protein products include one or more of the following: 
Algae meals, coconut meals (copra), cottonseed meals, guar meal, linseed 
meals, peanut meals, safflower meals, soybean meals, sunflower meals, 
and yeasts.
    (5) Processed grain byproducts include one or more of the following: 
Brans, brewers dried grains, distillers grains, distillers solubles, 
flours, germ meals, gluten feeds, gluten meals, grits, groats, hominy 
feeds, malt sprouts, middlings, pearled, polishings, shorts, and wheat 
mill run.
    (6) Roughage products include one or more of the following: Cobs, 
hulls, husks, pulps, and straws.



PART 502_COMMON OR USUAL NAMES FOR NONSTANDARDIZED ANIMAL FOODS--
Table of Contents



Sec.
502.5 General principles.
502.19 Petitions.

    Authority: 21 U.S.C. 321, 343, 371.



Sec. 502.5  General principles.

    (a) The common or usual name of a food, which may be a coined term, 
shall accurately identify or describe, in as simple and direct terms as 
possible, the basic nature of the food or its characterizing properties 
or ingredients. The name shall be uniform among all identical or similar 
products and may not be confusingly similar to the name of any other 
food that is not reasonably encompassed within the same name. Each class 
or subclass of food shall be given its own common or usual name that 
states, in clear terms, what it is in a way that distinguishes it from 
different foods.
    (b) The common or usual name of a food shall include the 
percentage(s) of any characterizing ingredient(s) or component(s) when 
the proportion of such ingredient(s) or component(s) in the food has a 
material bearing on price or consumer acceptance or when the labeling or 
the appearance of the food may otherwise create an erroneous impression 
that such ingredient(s) or component(s) is present in an amount greater 
than is actually the case. The following requirements shall apply unless 
modified by a specific regulation in this part.
    (1) The percentage of a characterizing ingredient or component shall 
be declared on the basis of its quantity in the finished product (i.e., 
weight/weight in the case of solids, or volume/volume in the case of 
liquids).
    (2) The percentage of a characterizing ingredient or component shall 
be declared by the words ``containing (or contains) __ percent (or %) 
__'' or ``__ percent (or %) __'' with the first blank filled in with the 
percentage expressed as a whole number not greater

[[Page 33]]

than the actual percentage of the ingredient or component named and the 
second blank filled in with the common or usual name of the ingredient 
or component. The word ``containing'' (or ``contains''), when used, 
shall appear on a line immediately below the part of the common or usual 
name of the food required by paragraph (a) of this section. For each 
characterizing ingredient or component, the words ``__ percent (or %) 
__''shall appear following or directly below the word ``containing'' (or 
``contains''), or directly below the part of the common or usual name of 
the food required by paragraph (a) of this section when the word 
``containing'' (or ``contains'') is not used, in easily legible boldface 
print or type in distinct contrast to other printed or graphic matter, 
and in a height not less than the larger of the following alternatives:
    (i) Not less than one-sixteenth inch in height on packages having a 
principal display panel with an area of 5 square inches or less and not 
less than one-eighth inch in height if the area of the principal display 
panel is greater than 5 square inches; or
    (ii) Not less than one-half the height of the largest type appearing 
in the part of the common or usual name of the food required by 
paragraph (a) of this section.
    (c) The common or usual name of a food shall include a statement of 
the presence or absence of any characterizing ingredient(s) or 
component(s) and/or the need for the user to add any characterizing 
ingredient(s) or component(s) when the presence or absence of such 
ingredient(s) or component(s) in the food has a material bearing on 
price or consumer acceptance or when the labeling or the appearance of 
the food may otherwise create an erroneous impression that such 
ingredient(s) or component(s) is present when it is not, and consumers 
may otherwise be misled about the presence or absence of the 
ingredient(s) or component(s) in the food. The following requirements 
shall apply unless modified by a specific regulation in this part.
    (1) The presence or absence of a characterizing ingredient or 
component shall be declared by the words ``containing (or contains) 
____'' or ``containing (or contains) _____'' or ``no _____'' or ``does 
not contain _____'', with the blank being filled in with the common or 
usual name of the ingredient or component.
    (2) The need for the user of a food to add any characterizing 
ingredient(s) or component(s) shall be declared by an appropriate 
informative statement.
    (3) The statement(s) required under paragraph (c) (1) and/or (2) of 
this section shall appear following or directly below the part of the 
common or usual name of the food required by paragraphs (a) and (b) of 
this section, in easily legible boldface print or type in distinct 
contrast to other printed or graphic matter, and in a height not less 
than the larger of the alternatives established under paragraph (b)(2) 
(i) and (ii) of this section.
    (d) A common or usual name of a food may be established by common 
usage or by establishment of a regulation in this part, in a standard of 
identity, or in other regulations in this chapter.

[41 FR 38627, Sept. 10, 1976. Redesignated at 42 FR 14091, Mar. 15, 
1977]



Sec. 502.19  Petitions.

    (a) The Commissioner of Food and Drugs, either on his own initiative 
or on behalf of any interested person who has submitted a petition, may 
publish a proposal to issue, amend, or revoke, under this part, a 
regulation prescribing a common or usual name for a food, pursuant to 
part 10 of this chapter.
    (b) If the principal display panel of a food for which a common or 
usual name regulation is established is too small to accommodate all 
mandatory requirements, the Commissioner may establish by regulation an 
acceptable alternative, e.g., a smaller type size. A petition requesting 
such a regulation, which would amend the applicable regulation, shall be 
submitted pursuant to part 10 of this chapter.

[42 FR 4716, Jan. 25, 1977; 42 FR 10980, Feb. 25, 1977. Redesignated at 
42 FR 14091, Mar. 15, 1977, and amended at 42 FR 15675, Mar. 22, 1977; 
42 FR 24254, May 13, 1977]

[[Page 34]]



PART 507_CURRENT GOOD MANUFACTURING PRACTICE, HAZARD ANALYSIS,
AND RISK-BASED PREVENTIVE CONTROLS FOR FOOD FOR ANIMALS--
Table of Contents



                      Subpart A_General Provisions

Sec.
507.1 Applicability and status.
507.3 Definitions.
507.4 Qualifications of individuals who manufacture, process, pack, or 
          hold animal food.
507.5 Exemptions.
507.7 Requirements that apply to a qualified facility.
507.10 Applicability of subparts C and E of this part to a facility 
          solely engaged in the storage of unexposed packaged animal 
          food.
507.12 Applicability of this part to the holding and distribution of 
          human food by-products for use as animal food.

              Subpart B_Current Good Manufacturing Practice

507.14 Personnel.
507.17 Plant and grounds.
507.19 Sanitation.
507.20 Water supply and plumbing.
507.22 Equipment and utensils.
507.25 Plant operations.
507.27 Holding and distribution.
507.28 Holding and distribution of human food by-products for use as 
          animal food.

      Subpart C_Hazard Analysis and Risk-Based Preventive Controls

507.31 Food safety plan.
507.33 Hazard analysis.
507.34 Preventive controls.
507.36 Circumstances in which the owner, operator, or agent in charge of 
          a manufacturing/processing facility is not required to 
          implement a preventive control.
507.37 Provision of assurances required under Sec. 507.36(a)(2), (3), 
          and (4).
507.38 Recall plan.
507.39 Preventive control management components.
507.40 Monitoring.
507.42 Corrective actions and corrections.
507.45 Verification.
507.47 Validation.
507.49 Verification of implementation and effectiveness.
507.50 Reanalysis.
507.51 Modified requirements that apply to a facility solely engaged in 
          the storage of unexposed packaged animal food.
507.53 Requirements applicable to a preventive controls qualified 
          individual and a qualified auditor.
507.55 Implementation records required for this subpart.

         Subpart D_Withdrawal of a Qualified Facility Exemption

507.60 Circumstances that may lead FDA to withdraw a qualified facility 
          exemption.
507.62 Issuance of an order to withdraw a qualified facility exemption.
507.65 Contents of an order to withdraw a qualified facility exemption.
507.67 Compliance with, or appeal of, an order to withdraw a qualified 
          facility exemption.
507.69 Procedure for submitting an appeal.
507.71 Procedure for requesting an informal hearing.
507.73 Requirements applicable to an informal hearing.
507.75 Presiding officer for an appeal and for an informal hearing.
507.77 Timeframe for issuing a decision on an appeal.
507.80 Revocation of an order to withdraw a qualified facility 
          exemption.
507.83 Final agency action.
507.85 Reinstatement of a qualified facility exemption that was 
          withdrawn.

                     Subpart E_Supply-Chain Program

507.105 Requirement to establish and implement a supply-chain program.
507.110 General requirements applicable to a supply-chain program.
507.115 Responsibilities of the receiving facility.
507.120 Using approved suppliers.
507.125 Determining appropriate supplier verification activities 
          (including determining the frequency of conducting the 
          activity).
507.130 Conducting supplier verification activities for raw materials 
          and other ingredients.
507.135 Onsite audit.
507.175 Records documenting the supply-chain program.

Subpart F_Requirements Applying to Records That Must Be Established and 
                               Maintained

507.200 Records subject to the requirements of this subpart.
507.202 General requirements applying to records.
507.206 Additional requirements applying to the food safety plan.
507.208 Requirements for record retention.
507.212 Use of existing records.
507.215 Special requirements applicable to a written assurance.


[[Page 35]]


    Authority: 21 U.S.C. 331, 342, 343, 350d note, 350g, 350g note, 371, 
374; 42 U.S.C. 243, 264, 271.

    Source: 80 FR 56337, Sept. 17, 2015, unless otherwise noted.



                      Subpart A_General Provisions



Sec. 507.1  Applicability and status.

    (a) The criteria and definitions in this part apply in determining 
whether an animal food is:
    (1) Adulterated within the meaning of:
    (i) Section 402(a)(3) of the Federal Food, Drug, and Cosmetic Act in 
that the food has been manufactured under such conditions that it is 
unfit for food; or
    (ii) Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act 
in that the food has been prepared, packed, or held under insanitary 
conditions whereby it may have become contaminated with filth, or 
whereby it may have been rendered injurious to health; and
    (2) In violation of section 361 of the Public Health Service Act (42 
U.S.C. 264).
    (b) The operation of a facility that manufactures, processes, packs, 
or holds animal food for sale in the United States if the owner, 
operator, or agent in charge of such facility is required to comply 
with, and is not in compliance with, section 418 of the Federal Food, 
Drug, and Cosmetic Act or subparts C, D, E, or F of this part and Sec. 
507.7 is a prohibited act under section 301(uu) of the Federal Food, 
Drug, and Cosmetic Act.
    (c) Animal food covered by specific current good manufacturing 
practice regulations also is subject to the requirements of those 
regulations.
    (d) Except as provided by Sec. 507.12, if a facility is required to 
comply with subpart B of part 507 and is also required to comply with 
subpart B of part 117 of this chapter because the facility manufactures, 
processes, packs, or holds human food and animal food, then the facility 
may choose to comply with the requirements in subpart B of part 117, 
instead of subpart B of part 507, as to the manufacturing, processing, 
packing, and holding of animal food at that facility. If a facility is 
required to comply with subpart C of part 507 and is also required to 
comply with subpart C of part 117 of this chapter, then the facility may 
choose to comply with the requirements in subpart C of part 117 as to 
the manufacturing, processing, packing, and holding of animal food at 
the facility, instead of subpart C of part 507, provided the food safety 
plan also addresses hazards for the animal food, if applicable, that 
require a preventive control. When applying the requirements of part 117 
of this chapter to animal food, the term ``food'' in part 117 includes 
animal food.



Sec. 507.3  Definitions.

    The definitions and interpretations contained in section 201 of the 
Federal Food, Drug, and Cosmetic Act apply to such terms when used in 
this part. The following definitions also apply:
    Adequate means that which is needed to accomplish the intended 
purpose in keeping with good public (human and animal) health practice.
    Affiliate means any facility that controls, is controlled by, or is 
under common control with another facility.
    Animal food means food for animals other than man and includes pet 
food, animal feed, and raw materials and ingredients.
    Audit means the systematic, independent, and documented examination 
(through observation, investigation, records review, discussions with 
employees of the audited entity, and, as appropriate, sampling and 
laboratory analysis) to assess an audited entity's food safety processes 
and procedures.
    Calendar day means every day shown on the calendar.
    Correction means an action to identify and correct a problem that 
occurred during the production of animal food, without other actions 
associated with a corrective action procedure (such as actions to reduce 
the likelihood that the problem will recur, evaluate all affected animal 
food for safety, and prevent affected animal food from entering 
commerce).
    Critical control point means a point, step, or procedure in a food 
process at which control can be applied and is essential to prevent or 
eliminate a food safety hazard or reduce such hazard to an acceptable 
level.

[[Page 36]]

    Environmental pathogen means a pathogen capable of surviving and 
persisting within the manufacturing, processing, packing, or holding 
environment such that food for animals may be contaminated and may 
result in foodborne illness if that animal food is not treated to 
significantly minimize or prevent the environmental pathogen. Examples 
of environmental pathogens for the purposes of this part include 
Listeria monocytogenes and Salmonella spp. but do not include the spores 
of pathogenic sporeforming bacteria.
    Facility means a domestic facility or a foreign facility that is 
required to register under section 415 of the Federal Food, Drug, and 
Cosmetic Act, in accordance with the requirements of part 1, subpart H 
of this chapter.
    Farm means farm as defined in Sec. 1.227 of this chapter.
    FDA means the Food and Drug Administration.
    Food means food as defined in section 201(f) of the Federal Food, 
Drug, and Cosmetic Act and includes raw materials and ingredients.
    Food-contact surfaces are those surfaces that contact animal food 
and those surfaces from which drainage, or other transfer, onto the 
animal food or onto surfaces that contact the animal food ordinarily 
occurs during the normal course of operations. ``Food-contact surfaces'' 
includes utensils and animal food-contact surfaces of equipment.
    Full-time equivalent employee is a term used to represent the number 
of employees of a business entity for the purpose of determining whether 
the business qualifies for the small business exemption. The number of 
full-time equivalent employees is determined by dividing the total 
number of hours of salary or wages paid directly to employees of the 
business entity and of all of its affiliates and subsidiaries by the 
number of hours of work in 1 year, 2,080 hours (i.e., 40 hours x 52 
weeks). If the result is not a whole number, round down to the next 
lowest whole number.
    Harvesting applies to farms and farm mixed-type facilities and means 
activities that are traditionally performed on farms for the purpose of 
removing raw agricultural commodities from the place they were grown or 
raised and preparing them for use as animal food. Harvesting is limited 
to activities performed on raw agricultural commodities, or on processed 
foods created by drying/dehydrating a raw agricultural commodity without 
additional manufacturing/processing, on a farm. Harvesting does not 
include activities that transform a raw agricultural commodity into a 
processed food as defined in section 201(gg) of the Federal Food, Drug, 
and Cosmetic Act. Examples of harvesting include cutting (or otherwise 
separating) the edible portion of the raw agricultural commodity from 
the crop plant and removing or trimming part of the raw agricultural 
commodity (e.g., foliage, husks, roots, or stems). Examples of 
harvesting also include cooling, field coring, filtering, gathering, 
hulling, shelling, sifting, threshing, trimming of outer leaves of, and 
washing raw agricultural commodities grown on a farm.
    Hazard means any biological, chemical (including radiological), or 
physical agent that has the potential to cause illness or injury in 
humans or animals.
    Hazard requiring a preventive control means a known or reasonably 
foreseeable hazard for which a person knowledgeable about the safe 
manufacturing, processing, packing, or holding of animal food would, 
based on the outcome of a hazard analysis (which includes an assessment 
of the severity of the illness or injury to humans or animals if the 
hazard were to occur and the probability that the hazard will occur in 
the absence of preventive controls), establish one or more preventive 
controls to significantly minimize or prevent the hazard in an animal 
food and components to manage those controls (such as monitoring, 
corrections or corrective actions, verification, and records) as 
appropriate to the animal food, the facility, and the nature of the 
preventive control and its role in the facility's food safety system.
    Holding means storage of animal food and also includes activities 
performed incidental to storage of an animal food (e.g., activities 
performed for the safe or effective storage of that animal food, such as 
fumigating animal food during storage, and drying/dehydrating

[[Page 37]]

raw agricultural commodities when the drying/dehydrating does not create 
a distinct commodity (such as drying/dehydrating hay or alfalfa)). 
Holding also includes activities performed as a practical necessity for 
the distribution of that animal food (such as blending of the same raw 
agricultural commodity and breaking down pallets), but does not include 
activities that transform a raw agricultural commodity into a processed 
food as defined in section 201(gg) of the Federal Food, Drug, and 
Cosmetic Act. Holding facilities could include warehouses, cold storage 
facilities, storage silos, grain elevators, and liquid-storage tanks.
    Known or reasonably foreseeable hazard means a biological, chemical 
(including radiological), or physical hazard that is known to be, or has 
the potential to be, associated with the facility or the animal food.
    Lot means the animal food produced during a period of time and 
identified by an establishment's specific code.
    Manufacturing/processing means making animal food from one or more 
ingredients, or synthesizing, preparing, treating, modifying, or 
manipulating animal food, including food crops or ingredients. Examples 
of manufacturing/processing activities include: Baking, boiling, 
bottling, canning, cooking, cooling, cutting, distilling, drying/
dehydrating raw agricultural commodities to create a distinct commodity 
(such as drying/dehydrating grapes to produce raisins), evaporating, 
eviscerating, extracting juice, extruding, formulating, freezing, 
grinding, homogenizing, irradiating, labeling, milling, mixing, 
packaging (including modified atmosphere packaging), pasteurizing, 
peeling, pelleting, rendering, treating to manipulate ripening, 
trimming, washing, or waxing. For farms and farm mixed-type facilities, 
manufacturing/processing does not include activities that are part of 
harvesting, packing, or holding.
    Microorganisms means yeasts, molds, bacteria, viruses, protozoa, and 
microscopic parasites and includes species that are pathogens. The term 
``undesirable microorganisms'' includes those microorganisms that are 
pathogens, that subject animal food to decomposition, that indicate that 
animal food is contaminated with filth, or that otherwise may cause 
animal food to be adulterated.
    Mixed-type facility means an establishment that engages in both 
activities that are exempt from registration under section 415 of the 
Federal Food, Drug, and Cosmetic Act and activities that require the 
establishment to be registered. An example of such a facility is a 
``farm mixed-type facility,'' which is an establishment that is a farm, 
but also conducts activities outside the farm definition that require 
the establishment to be registered.
    Monitor means to conduct a planned sequence of observations or 
measurements to assess whether control measures are operating as 
intended.
    Packing means placing animal food into a container other than 
packaging the animal food and also includes repacking and activities 
performed incidental to packing or repacking an animal food (e.g., 
activities performed for the safe or effective packing or repacking of 
that animal food (such as sorting, culling, grading, and weighing or 
conveying incidental to packing or repacking)), but does not include 
activities that transform a raw agricultural commodity into a processed 
food as defined in section 201(gg) of the Federal Food, Drug, and 
Cosmetic Act.
    Pathogen means a microorganism of public (human or animal) health 
significance.
    Pest refers to any objectionable animals or insects including birds, 
rodents, flies, and larvae.
    Plant means the building or structure, or parts thereof, used for or 
in connection with the manufacturing, processing, packing, or holding of 
animal food.
    Preventive controls means those risk-based, reasonably appropriate 
procedures, practices, and processes that a person knowledgeable about 
the safe manufacturing, processing, packing, or holding of animal food 
would employ to significantly minimize or prevent the hazards identified 
under the hazard analysis that are consistent with the current 
scientific understanding of safe food manufacturing, processing, 
packing, or holding at the time of the analysis.

[[Page 38]]

    Preventive controls qualified individual means a qualified 
individual who has successfully completed training in the development 
and application of risk-based preventive controls at least equivalent to 
that received under a standardized curriculum recognized as adequate by 
FDA, or is otherwise qualified through job experience to develop and 
apply a food safety system.
    Qualified auditor means a person who is a qualified individual as 
defined in this part and has technical expertise obtained through 
education, training, or experience (or the combination thereof) 
necessary to perform the auditing function. Examples of potential 
qualified auditors include:
    (1) A government employee, including a foreign government employee; 
and
    (2) An audit agent of a certification body that is accredited in 
accordance with regulations in part 1, subpart M of this chapter.
    Qualified end-user, with respect to food, means the consumer of the 
food (where the term consumer does not include a business); or a 
restaurant or retail food establishment (as those terms are defined in 
Sec. 1.227 of this chapter) that:
    (1) Is located:
    (i) In the same State or the same Indian reservation as the 
qualified facility that sold the food to such restaurant or retail food 
establishment; or
    (ii) Not more than 275 miles from such facility; and
    (2) Is purchasing the food for sale directly to consumers at such 
restaurant or retail food establishment.
    Qualified facility means (when including the sales by any 
subsidiary; affiliate; or subsidiaries or affiliates, collectively, of 
any entity of which the facility is a subsidiary or affiliate) a 
facility that is a very small business as defined in this part, or a 
facility to which both of the following apply:
    (1) During the 3-year period preceding the applicable calendar year, 
the average annual monetary value of the food manufactured, processed, 
packed, or held at such facility that is sold directly to qualified end-
users (as defined in this part) during such period exceeded the average 
annual monetary value of the food sold by such facility to all other 
purchasers; and
    (2) The average annual monetary value of all food sold during the 3-
year period preceding the applicable calendar year was less than 
$500,000, adjusted for inflation.
    Qualified facility exemption means an exemption applicable to a 
qualified facility under Sec. 507.5(d).
    Qualified individual means a person who has the education, training, 
or experience (or a combination thereof) necessary to manufacture, 
process, pack, or hold safe animal food as appropriate to the 
individual's assigned duties. A qualified individual may be, but is not 
required to be, an employee of the establishment.
    Raw agricultural commodity has the meaning given in section 201(r) 
of the Federal Food, Drug, and Cosmetic Act.
    Receiving facility means a facility that is subject to subparts C 
and E of this part and that manufactures/processes a raw material or 
other ingredient that it receives from a supplier.
    Rework means clean, unadulterated animal food that has been removed 
from processing for reasons other than insanitary conditions or that has 
been successfully reconditioned by reprocessing and that is suitable for 
use as animal food.
    Sanitize means to adequately treat cleaned surfaces by a process 
that is effective in destroying vegetative cells of pathogens, and in 
substantially reducing numbers of other undesirable microorganisms, but 
without adversely affecting the product or its safety for animals or 
humans.
    Significantly minimize means to reduce to an acceptable level, 
including to eliminate.
    Small business means, for purposes of this part, a business 
(including any subsidiaries and affiliates) employing fewer than 500 
full-time equivalent employees.
    Subsidiary means any company which is owned or controlled directly 
or indirectly by another company.
    Supplier means the establishment that manufactures/processes the 
animal food, raises the animal, or grows the food that is provided to a 
receiving

[[Page 39]]

facility without further manufacturing/processing by another 
establishment, except for further manufacturing/processing that consists 
solely of the addition of labeling or similar activity of a de minimis 
nature.
    Supply-chain-applied control means a preventive control for a hazard 
in a raw material or other ingredient when the hazard in the raw 
material or other ingredient is controlled before its receipt.
    Unexposed packaged animal food means packaged animal food that is 
not exposed to the environment.
    Validation means obtaining and evaluating scientific and technical 
evidence that a control measure, combination of control measures, or the 
food safety plan as a whole, when properly implemented, is capable of 
effectively controlling the identified hazards.
    Verification means the application of methods, procedures, tests and 
other evaluations, in addition to monitoring, to determine whether a 
control measure or combination of control measures is or has been 
operating as intended and to establish the validity of the food safety 
plan.
    Very small business means, for purposes of this part, a business 
(including any subsidiaries and affiliates) averaging less than 
$2,500,000, adjusted for inflation, per year, during the 3-year period 
preceding the applicable calendar year in sales of animal food plus the 
market value of animal food manufactured, processed, packed, or held 
without sale (e.g., held for a fee or supplied to a farm without sale).
    Water activity (aw) means a measure of the free moisture 
in an animal food and is the quotient of the water vapor pressure of the 
substance divided by the vapor pressure of pure water at the same 
temperature.
    Written procedures for receiving raw materials and other ingredients 
means written procedures to ensure that raw materials and other 
ingredients are received only from suppliers approved by the receiving 
facility (or, when necessary and appropriate, on a temporary basis from 
unapproved suppliers whose raw materials or other ingredients are 
subjected to adequate verification activities before acceptance for 
use).
    You means, for purposes of this part, the owner, operator, or agent 
in charge of a facility.

[80 FR 56337, Sept. 17, 2015, as amended at 81 FR 3717, Jan. 22, 2016]



Sec. 507.4  Qualifications of individuals who manufacture, process,
pack, or hold animal food.

    (a)(1) The management of an establishment must ensure that all 
individuals who manufacture, process, pack, or hold animal food subject 
to subparts B and F of this part are qualified to perform their assigned 
duties; and
    (2) The owner, operator, or agent in charge of a facility must 
ensure that all individuals who manufacture, process, pack, or hold 
animal food subject to subparts C, D, E, or F of this part are qualified 
to perform their assigned duties.
    (b) Each individual engaged in manufacturing, processing, packing, 
or holding animal food (including temporary and seasonal personnel) or 
in the supervision thereof must:
    (1) Be a qualified individual as that term is defined in Sec. 
507.3, i.e., have the education, training, or experience (or a 
combination thereof) necessary to manufacture, process, pack, or hold 
safe animal food as appropriate to the individual's assigned duties; and
    (2) Receive training in the principles of animal food hygiene and 
animal food safety, including the importance of employee health and 
personal hygiene, as appropriate to the animal food, the facility and 
the individual's assigned duties.
    (c) Responsibility for ensuring compliance by individuals with the 
requirements of this part must be clearly assigned to supervisory 
personnel who have the education, training, or experience (or a 
combination thereof) necessary to supervise the production of safe 
animal food.
    (d) Records that document training required by paragraph (b)(2) of 
this section must be established and maintained and are subject to the 
recordkeeping requirements in subpart F of this part.

[[Page 40]]



Sec. 507.5  Exemptions.

    (a) This part does not apply to establishments, including ``farms'' 
(as defined in Sec. 1.227 of this chapter), that are not required to 
register under section 415 of the Federal Food, Drug, and Cosmetic Act.
    (b)(1) Subparts C and E of this part do not apply with respect to 
activities that are subject to Sec. 500.23 and part 113 of this chapter 
(Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed 
Containers) at an animal food facility if you are required to comply 
with, and are in compliance with, part 113 of this chapter with respect 
to those activities.
    (2) The exemption in paragraph (b)(1) of this section is applicable 
only with respect to those microbiological hazards regulated under part 
113 of this chapter.
    (c) Subparts C and E of this part do not apply to activities of a 
facility that are subject to section 419 of the Federal Food, Drug, and 
Cosmetic Act (Standards for Produce Safety).
    (d) Except as provided in subpart D of this part, subparts C and E 
of this part do not apply to a qualified facility. Qualified facilities 
are subject to the requirements in Sec. 507.7.
    (e) For a farm mixed-type facility that is a small or very small 
business, subparts C and E of this part do not apply to on-farm packing 
or holding of processed animal food, and Sec. 507.7 does not apply to 
on-farm packing or holding of processed animal food by a very small 
business, if the only packing or holding activities subject to section 
418 of the Federal Food, Drug, and Cosmetic Act that the business 
conducts are the following low-risk packing or holding activity/animal 
food combinations--i.e., packing (or repacking) (including weighing or 
conveying incidental to packing or repacking); sorting, culling, or 
grading incidental to packing or storing; and storing (ambient, cold and 
controlled atmosphere) of:
    (1) Roughage products (e.g., alfalfa meal, entire plant meal, stem 
meal, pomace, and pulp);
    (2) Plant protein meals (e.g., algae, coconut (copra), guar, and 
peanut);
    (3) Grain by-products and processed grain products (e.g., bran, 
flour, germ meal, grits, groats, hominy feed, malt sprouts, middlings, 
pearled grain, polished grain, brewers grain, distillers grain, and 
gluten meal);
    (4) Oilseed products (e.g., oil and meal of safflower, soybean, or 
sunflower);
    (5) Molasses (e.g., processed sugar cane, sugar beets, and citrus);
    (6) Animal protein meals (e.g., blood, feather, meat, meat and bone, 
and marine (e.g., crab, fish, shrimp));
    (7) Milk products (e.g., casein, cheese rind, and lactalbumin);
    (8) Animal tissue-derived products (e.g., fat);
    (9) Vitamins, minerals, and concentrates;
    (10) Processing aids (e.g., enzymes, preservatives, and 
stabilizers); and
    (11) Any other processed animal food that does not require time/
temperature control for safety.
    (f) For a farm mixed-type facility that is a small or very small 
business, subparts C and E of this part do not apply to on-farm 
manufacturing/processing activities conducted by a small or very small 
business for distribution into commerce, and Sec. 507.7 does not apply 
to on-farm manufacturing/processing activities conducted by a very small 
business for distribution into commerce, if the only manufacturing/
processing activities subject to section 418 of the Federal Food, Drug, 
and Cosmetic Act that the business conducts consists of the following 
low-risk manufacturing/processing activity/animal food combinations:
    (1) Chopping or shredding hay;
    (2) Cracking, crimping, flaking, pearling, peeling, shelling, or 
wafering--grain (e.g., barley, sorghum, corn, oats, rice, rye, and 
wheat) or oilseed (e.g., beans, canola, cottonseed, linseed, soybeans, 
and sunflowers);
    (3) Crushing, dry rolling, grinding, milling, pulverizing--grain, 
oilseed, grain by-products and processed grain products, oilseed 
products, hay, ensiled material, culled fruits and vegetables, roughage 
(e.g., cobs, hulls, husks, and straws), or roughage products;
    (4) Ensiling (including chopping, shredding, mixing, storing, or 
fermenting), that is, making silage or haylage from forage (e.g., 
sorghum (milo), corn (maize), alfalfa, and grass),

[[Page 41]]

grain, culled fruits and vegetables, or roughage;
    (5) Extracting (mechanical) or wet rolling grain, oilseed, brewers 
grain by-products, or distillers grain by-products;
    (6) Labeling roughage products, plant protein meals, grain by-
products and processed grain products, oilseed products, molasses, 
animal protein meals, milk products, animal tissue-derived products, 
vitamins, minerals, concentrates, processing aids, finished animal food, 
including animal food ready for consumption, or any other processed 
animal food that does not require time/temperature control for safety; 
and
    (7) Packaging roughage products, plant protein meals, grain by-
products and processed grain products, oilseed products, molasses, 
animal protein meals, milk products, animal tissue-derived products, 
vitamins, minerals, concentrates, processing aids, finished animal food, 
including animal food ready for consumption, or any other processed 
animal food that does not require time/temperature control for safety.
    (g) Subparts C and E of this part do not apply to facilities that 
are solely engaged in the storage of raw agricultural commodities (other 
than fruits and vegetables) intended for further distribution or 
processing.
    (h) Subpart B of this part does not apply to any of the following:
    (1) Establishments solely engaged in the holding and/or 
transportation of one or more raw agricultural commodities;
    (2) Establishments solely engaged in hulling, shelling, drying, 
packing, and/or holding nuts and hulls (without manufacturing/
processing, such as grinding shells or roasting nuts); and
    (3) Establishments solely engaged in ginning of cotton (without 
manufacturing/processing, such as extracting oil from cottonseed).

[80 FR 56337, Sept. 17, 2015, as amended at 81 FR 3717, Jan. 22, 2016]



Sec. 507.7  Requirements that apply to a qualified facility.

    (a) A qualified facility must submit the following attestations to 
FDA:
    (1) An attestation that the facility is a qualified facility as 
defined in Sec. 507.3. For the purpose of determining whether a 
facility satisfies the definition of qualified facility, the baseline 
year for calculating the adjustment for inflation is 2011; and
    (2)(i) An attestation that you have identified the potential hazards 
associated with the animal food being produced, are implementing 
preventive controls to address the hazards, and are monitoring the 
performance of the preventive controls to ensure that such controls are 
effective; or
    (ii) An attestation that the facility is in compliance with State, 
local, county, tribal, or other applicable non-Federal food safety law, 
including relevant laws and regulations of foreign countries, including 
an attestation based on licenses, inspection reports, certificates, 
permits, credentials, certification by an appropriate agency (such as a 
State department of agriculture), or other evidence of oversight.
    (b) The attestations required by paragraph (a) of this section must 
be submitted to FDA by any one of the following means:
    (1) Electronic submission. To submit electronically, go to http://
www.fda.gov/furls and follow the instructions. This Web site is 
available from wherever the Internet is accessible, including libraries, 
copy centers, schools, and Internet cafes. FDA encourages electronic 
submission.
    (2) Submission by mail. (i) You must use Form FDA 3942b. You may 
obtain a copy of this form by any of the following mechanisms:
    (A) Download it from http://www.fda.gov/pcafrule;
    (B) Write to the U.S. Food and Drug Administration (HFS-681), 5001 
Campus Dr., College Park, MD 20740; or
    (C) Request a copy of this form by phone at 1-800-216-7331 or 301-
575-0156.
    (ii) Send a paper Form FDA 3942b to the U.S. Food and Drug 
Administration (HFS-681), 5001 Campus Dr., College Park, MD 20740. We 
recommend that you submit a paper copy only if your facility does not 
have reasonable access to the Internet.

[[Page 42]]

    (c)(1) A facility must determine and document its status as a 
qualified facility on an annual basis no later than July 1 of each 
calendar year.
    (2) The attestations required by paragraph (a) of this section must 
be:
    (i) Submitted to FDA initially:
    (A) By December 16, 2019 for a facility that begins manufacturing, 
processing, packing, or holding animal food before September 17, 2019;
    (B) Before beginning operations, for a facility that begins 
manufacturing, processing, packing, or holding animal food after 
September 17, 2019; or
    (C) By July 31 of the applicable calendar year, when the status of a 
facility changes from ``not a qualified facility'' to ``qualified 
facility'' based on the annual determination required by paragraph 
(c)(1) of this section; and
    (ii) Beginning in 2020, submitted to FDA every 2 years during the 
period beginning on October 1 and ending on December 31.
    (3) When the status of a facility changes from ``qualified 
facility'' to ``not a qualified facility'' based on the annual 
determination required by paragraph (c)(1) of this section, the facility 
must notify FDA of that change in status using Form FDA 3942b by July 31 
of the applicable calendar year.
    (d) When the status of a facility changes from ``qualified 
facility'' to ``not a qualified facility,'' the facility must comply 
with subparts C and E of this part no later than December 31 of the 
applicable calendar year unless otherwise agreed to by FDA and the 
facility.
    (e) A qualified facility that does not submit attestations under 
paragraph (a)(2)(i) of this section must provide notification to 
consumers as to the name and complete business address of the facility 
where the animal food was manufactured or processed (including the 
street address or P.O. Box, city, state, and zip code for domestic 
facilities, and comparable full address information for foreign 
facilities) as follows:
    (1) If an animal food packaging label is required, the notification 
required by paragraph (e) of this section must appear prominently and 
conspicuously on the label of the animal food.
    (2) If an animal food packaging label is not required, the 
notification required by paragraph (e) of this section must appear 
prominently and conspicuously, at the point of purchase, on a label, 
poster, sign, placard, or documents delivered contemporaneously with the 
animal food in the normal course of business, or in an electronic 
notice, in the case of Internet sales.
    (f)(1) A qualified facility must maintain those records relied upon 
to support the attestations that are required by paragraph (a) of this 
section.
    (2) The records that a qualified facility must maintain are subject 
to the requirements of subpart F of this part.

[80 FR 56337, Sept. 17, 2015, as amended at 81 FR 3717, Jan. 22, 2016; 
81 FR 49897, July 29, 2016]



Sec. 507.10  Applicability of subparts C and E of this part to a
facility solely engaged in the storage of unexposed packaged animal
food.

    (a) Subparts C and E of this part do not apply to a facility solely 
engaged in the storage of unexposed packaged animal food that does not 
require time/temperature control to significantly minimize or prevent 
the growth of, or toxin production by, pathogens.
    (b) A facility solely engaged in the storage of unexposed packaged 
animal food, including unexposed packaged animal food that requires 
time/temperature control to significantly minimize or prevent the growth 
of, or toxin production by, pathogens is subject to the modified 
requirements in Sec. 507.51 for any unexposed packaged animal food that 
requires time/temperature control to significantly minimize or prevent 
the growth of, or toxin production by, pathogens.



Sec. 507.12  Applicability of this part to the holding and distribution
of human food by-products for use as animal food.

    (a) Except as provided by paragraph (b) of this section, the 
requirements of this part do not apply to by-products of human food 
production, or the off-farm packing and holding of raw agricultural 
commodities, that are packed or held by that human food facility for 
distribution as animal food if:

[[Page 43]]

    (1)(i) The human food facility is subject to and in compliance with 
subpart B of part 117 of this chapter and in compliance with all 
applicable human food safety requirements of the Federal Food, Drug, and 
Cosmetic Act and implementing regulations; or
    (ii) For the off-farm packing and holding of produce (as defined in 
part 112 of this chapter), the human food facility is subject to and in 
compliance with Sec. 117.8 of this chapter and in compliance with all 
applicable human food safety requirements of the Federal Food, Drug, and 
Cosmetic Act and implementing regulations; and
    (2) The human food facility does not further manufacture or process 
the by-products intended for use as animal food.
    (b) The human food by-products for use as animal food identified in 
paragraph (a) of this section must be held and distributed by that 
facility in accordance with Sec. Sec. 507.28 and 117.95 of this 
chapter.



              Subpart B_Current Good Manufacturing Practice



Sec. 507.14  Personnel.

    (a) The management of the establishment must take reasonable 
measures and precautions to ensure that all persons working in direct 
contact with animal food, animal food-contact surfaces, and animal food-
packaging materials conform to hygienic practices to the extent 
necessary to protect against the contamination of animal food.
    (b) The methods for conforming to hygienic practices and maintaining 
cleanliness include:
    (1) Maintaining adequate personal cleanliness;
    (2) Washing hands thoroughly in an adequate hand-washing facility as 
necessary and appropriate to protect against contamination;
    (3) Removing or securing jewelry and other objects that might fall 
into animal food, equipment, or containers;
    (4) Storing clothing or other personal belongings in areas other 
than where animal food is exposed or where equipment or utensils are 
cleaned; and
    (5) Taking any other necessary precautions to protect against the 
contamination of animal food, animal food-contact surfaces, or animal 
food-packaging materials.



Sec. 507.17  Plant and grounds.

    (a) The grounds around an animal food plant under the control of the 
management of the establishment must be kept in a condition that will 
protect against the contamination of animal food. Maintenance of grounds 
must include:
    (1) Properly storing equipment, removing litter and waste, and 
cutting weeds or grass within the immediate vicinity of the plant that 
may constitute an attractant, breeding place, or harborage for pests;
    (2) Maintaining driveways, yards, and parking areas so that they do 
not constitute a source of contamination in areas where animal food is 
exposed;
    (3) Adequately draining areas that may contribute to contamination 
of animal food; and
    (4) Treating and disposing of waste so that it does not constitute a 
source of contamination in areas where animal food is exposed.
    (b) The plant must be suitable in size, construction, and design to 
facilitate cleaning, maintenance, and pest control to reduce the 
potential for contamination of animal food, animal food-contact 
surfaces, and animal food-packaging materials, including that the plant 
must:
    (1) Provide adequate space between equipment, walls, and stored 
materials to permit employees to perform their duties and to allow 
cleaning and maintenance of equipment;
    (2) Be constructed in a manner such that drip or condensate from 
fixtures, ducts, and pipes does not serve as a source of contamination;
    (3) Provide adequate ventilation (mechanical or natural) where 
necessary and appropriate to minimize vapors (e.g., steam) and fumes in 
areas where they may contaminate animal food and in a manner that 
minimizes the potential for contaminating animal food;
    (4) Provide adequate lighting in hand-washing areas, toilet rooms, 
areas where animal food is received, manufactured, processed, packed, or 
held, and areas where equipment or utensils are cleaned; and

[[Page 44]]

    (5) Provide shatter-resistant light bulbs, fixtures, and skylights, 
or other glass items suspended over exposed animal food in any step of 
preparation, to protect against the contamination of animal food in case 
of glass breakage.
    (c) The plant must protect animal food stored outdoors in bulk from 
contamination by any effective means, including:
    (1) Using protective coverings where necessary and appropriate;
    (2) Controlling areas over and around the bulk animal food to 
eliminate harborages for pests; and
    (3) Checking on a regular basis for pests, pest infestation, and 
product condition related to safety of the animal food.



Sec. 507.19  Sanitation.

    (a) Buildings, structures, fixtures, and other physical facilities 
of the plant must be kept clean and in good repair to prevent animal 
food from becoming adulterated.
    (b) Animal food-contact and non-contact surfaces of utensils and 
equipment must be cleaned and maintained and utensils and equipment 
stored as necessary to protect against the contamination of animal food, 
animal food-contact surfaces, or animal food-packaging materials. When 
necessary, equipment must be disassembled for thorough cleaning. In 
addition:
    (1) When animal food-contact surfaces used for manufacturing, 
processing, packing, or holding animal food are wet-cleaned, the 
surfaces must, when necessary, be thoroughly dried before subsequent 
use; and
    (2) In wet processing of animal food, when cleaning and sanitizing 
are necessary to protect against the introduction of undesirable 
microorganisms into animal food, all animal food-contact surfaces must 
be cleaned and sanitized before use and after any interruption during 
which the animal food-contact surfaces may have become contaminated.
    (c) Cleaning compounds and sanitizing agents must be safe and 
adequate under the conditions of use.
    (d) The following applies to toxic materials:
    (1) Only the following toxic materials may be used or stored in the 
plant area where animal food is manufactured, processed, or exposed:
    (i) Those required to maintain clean and sanitary conditions;
    (ii) Those necessary for use in laboratory testing procedures;
    (iii) Those necessary for plant and equipment maintenance and 
operation; and
    (iv) Those necessary for use in the plant's operations.
    (2) Toxic materials described in paragraph (d)(1) of this section 
(e.g., cleaning compounds, sanitizing agents, and pesticide chemicals) 
must be identified, used, and stored in a manner that protects against 
the contamination of animal food, animal food-contact surfaces, or 
animal food-packaging materials; and
    (3) Other toxic materials (such as fertilizers and pesticides not 
included in paragraph (d)(1) of this section) must be stored in an area 
of the plant where animal food is not manufactured, processed, or 
exposed.
    (e) Effective measures must be taken to exclude pests from the 
manufacturing, processing, packing, and holding areas and to protect 
against the contamination of animal food by pests. The use of pesticides 
in the plant is permitted only under precautions and restrictions that 
will protect against the contamination of animal food, animal food-
contact surfaces, and animal food-packaging materials.
    (f) Trash must be conveyed, stored, and disposed of in a way that 
protects against the contamination of animal food, animal food-contact 
surfaces, animal food-packaging materials, water supplies, and ground 
surfaces, and minimizes the potential for the trash to become an 
attractant and harborage or breeding place for pests.

[80 FR 56337, Sept. 17, 2015, as amended at 81 FR 3717, Jan. 22, 2016]



Sec. 507.20  Water supply and plumbing.

    (a) The following apply to the water supply:
    (1) Water must be adequate for the operations and must be derived 
from an adequate source;
    (2) Running water at a suitable temperature, and under suitable 
pressure as needed, must be provided in all areas where required for the 
manufacturing,

[[Page 45]]

processing, packing, or holding of animal food, for the cleaning of 
equipment, utensils, and animal food-packaging materials, or for 
employee hand-washing facilities;
    (3) Water that contacts animal food, animal food-contact surfaces, 
or animal food-packaging materials must be safe for its intended use; 
and
    (4) Water may be reused for washing, rinsing, or conveying animal 
food if it does not increase the level of contamination of the animal 
food.
    (b) Plumbing must be designed, installed, and maintained to:
    (1) Carry adequate quantities of water to required locations 
throughout the plant;
    (2) Properly convey sewage and liquid disposable waste from the 
plant;
    (3) Avoid being a source of contamination to animal food, water 
supplies, equipment, or utensils, or creating an unsanitary condition;
    (4) Provide adequate floor drainage in all areas where floors are 
subject to flooding-type cleaning or where normal operations release or 
discharge water or other liquid waste on the floor; and
    (5) Ensure that there is no backflow from, or cross-connection 
between, piping systems that discharge waste water or sewage and piping 
systems that carry water for animal food or animal food manufacturing.
    (c) Sewage and liquid disposal waste must be disposed of through an 
adequate sewerage system or through other adequate means.
    (d) Each plant must provide employees with adequate, readily 
accessible toilet facilities. Toilet facilities must be kept clean and 
must not be a potential source of contamination of animal food, animal 
food-contact surfaces, or animal food-packaging materials.
    (e) Each plant must provide hand-washing facilities designed to 
ensure that an employee's hands are not a potential source of 
contamination of animal food, animal food-contact surfaces, or animal 
food-packaging materials.



Sec. 507.22  Equipment and utensils.

    (a) The following apply to plant equipment and utensils used in 
manufacturing, processing, packing, and holding animal food:
    (1) All plant equipment and utensils, including equipment and 
utensils that do not come in contact with animal food, must be designed 
and constructed of such material and workmanship to be adequately 
cleanable, and must be properly maintained;
    (2) Equipment and utensils must be designed, constructed, and used 
appropriately to avoid the adulteration of animal food with non-food 
grade lubricants, fuel, metal fragments, contaminated water, or any 
other contaminants;
    (3) Equipment must be installed so as to facilitate the cleaning and 
maintenance of the equipment and adjacent spaces;
    (4) Animal food-contact surfaces must be:
    (i) Made of materials that withstand the environment of their use 
and the action of animal food, and, if applicable, the action of 
cleaning compounds, cleaning procedures, and sanitizing agents;
    (ii) Made of nontoxic materials; and
    (iii) Maintained to protect animal food from being contaminated.
    (b) Holding, conveying, manufacturing, and processing systems, 
including gravimetric, pneumatic, closed, and automated systems, must be 
designed, constructed, and maintained in a way to protect against the 
contamination of animal food.
    (c) Each freezer and cold storage compartment used to hold animal 
food must be fitted with an accurate temperature-measuring device.
    (d) Instruments and controls used for measuring, regulating, or 
recording temperatures, pH, aw, or other conditions that 
control or prevent the growth of undesirable microorganisms in animal 
food must be accurate, precise, adequately maintained, and adequate in 
number for their designated uses.
    (e) Compressed air or other gases mechanically introduced into 
animal food or used to clean animal food-contact surfaces or equipment 
must be used in such a way to protect against the contamination of 
animal food.



Sec. 507.25  Plant operations.

    (a) Management of the establishment must ensure that:

[[Page 46]]

    (1) All operations in the manufacturing, processing, packing, and 
holding of animal food (including operations directed to receiving, 
inspecting, transporting, and segregating) are conducted in accordance 
with the current good manufacturing practice requirements of this 
subpart;
    (2) Animal food, including raw materials, other ingredients, or 
rework is accurately identified;
    (3) Animal food-packaging materials are safe and suitable;
    (4) The overall cleanliness of the plant is under the supervision of 
one or more competent individuals assigned responsibility for this 
function;
    (5) Adequate precautions are taken so that plant operations do not 
contribute to contamination of animal food, animal food-contact 
surfaces, and animal food-packaging materials;
    (6) Chemical, microbial, or extraneous-material testing procedures 
are used where necessary to identify sanitation failures or possible 
animal food contamination;
    (7) Animal food that has become adulterated is rejected, disposed 
of, or if appropriate, treated or processed to eliminate the 
adulteration. If disposed of, it must be done in a manner that protects 
against the contamination of other animal food; and
    (8) All animal food manufacturing, processing, packing, and holding 
is conducted under such conditions and controls as are necessary to 
minimize the potential for the growth of undesirable microorganisms to 
protect against the contamination of animal food.
    (b) Raw materials and other ingredients:
    (1) Must be examined to ensure that they are suitable for 
manufacturing and processing into animal food and must be handled under 
conditions that will protect against contamination and minimize 
deterioration. In addition:
    (i) Shipping containers (e.g., totes, drums, and tubs) and bulk 
vehicles holding raw materials and other ingredients must be examined 
upon receipt to determine whether contamination or deterioration of 
animal food has occurred;
    (ii) Raw materials must be cleaned as necessary to minimize 
contamination; and
    (iii) Raw materials and other ingredients, including rework, must be 
stored in containers designed and constructed in a way that protects 
against contamination and deterioration, and held under conditions, 
e.g., appropriate temperature and relative humidity, that will minimize 
the potential for growth of undesirable microorganisms and prevent the 
animal food from becoming adulterated;
    (2) Susceptible to contamination with mycotoxins or other natural 
toxins must be evaluated and used in a manner that does not result in 
animal food that can cause injury or illness to animals or humans; and
    (3) If frozen, must be kept frozen. If thawing is required prior to 
use, it must be done in a manner that minimizes the potential for the 
growth of undesirable microorganisms.
    (c) For the purposes of manufacturing, processing, packing, and 
holding operations, the following apply:
    (1) Animal food must be maintained under conditions, e.g., 
appropriate temperature and relative humidity, that will minimize the 
potential for growth of undesirable microorganisms and prevent the 
animal food from becoming adulterated during manufacturing, processing, 
packing, and holding;
    (2) Measures taken during manufacturing, processing, packing, and 
holding of animal food to significantly minimize or prevent the growth 
of undesirable microorganisms (e.g., heat treating, freezing, 
refrigerating, irradiating, controlling pH, or controlling 
aw) must be adequate to prevent adulteration of animal food;
    (3) Work-in-process and rework must be handled in such a way that it 
is protected against contamination and the growth of undesirable 
microorganisms;
    (4) Steps such as cutting, drying, defatting, grinding, mixing, 
extruding, pelleting, and cooling, must be performed in a way that 
protects against the contamination of animal food;
    (5) Filling, assembling, packaging, and other operations must be 
performed in such a way that protects against the contamination of 
animal food and the growth of undesirable microorganisms;
    (6) Animal food that relies principally on the control of water 
activity

[[Page 47]]

(aw) for preventing the growth of undesirable microorganisms 
must be processed to and maintained at a safe aw level;
    (7) Animal food that relies principally on the control of pH for 
preventing the growth of undesirable microorganisms must be monitored 
and maintained at the appropriate pH; and
    (8) When ice is used in contact with animal food, it must be made 
from water that is safe and must be used only if it has been 
manufactured in accordance with current good manufacturing practice as 
outlined in this subpart.



Sec. 507.27  Holding and distribution.

    (a) Animal food held for distribution must be held under conditions 
that will protect against contamination and minimize deterioration, 
including the following:
    (1) Containers used to hold animal food before distribution must be 
designed, constructed of appropriate material, cleaned as necessary, and 
maintained to protect against the contamination of animal food; and
    (2) Animal food held for distribution must be held in a way that 
protects against contamination from sources such as trash.
    (b) The labeling for the animal food ready for distribution must 
contain, when applicable, information and instructions for safely using 
the animal food for the intended animal species.
    (c) Shipping containers (e.g., totes, drums, and tubs) and bulk 
vehicles used to distribute animal food must be examined prior to use to 
protect against the contamination of animal food from the container or 
vehicle when the facility is responsible for transporting the animal 
food itself or arranges with a third party to transport the animal food.
    (d) Animal food returned from distribution must be assessed for 
animal food safety to determine the appropriate disposition. Returned 
animal food must be identified as such and segregated until assessed.
    (e) Unpackaged or bulk animal food must be held in a manner that 
does not result in unsafe cross contamination with other animal food.

[80 FR 56337, Sept. 17, 2015, as amended at 81 FR 3717, Jan. 22, 2016]



Sec. 507.28  Holding and distribution of human food by-products for
use as animal food.

    (a) Human food by-products held for distribution as animal food must 
be held under conditions that will protect against contamination, 
including the following:
    (1) Containers and equipment used to convey or hold human food by-
products for use as animal food before distribution must be designed, 
constructed of appropriate material, cleaned as necessary, and 
maintained to protect against the contamination of human food by-
products for use as animal food;
    (2) Human food by-products for use as animal food held for 
distribution must be held in a way to protect against contamination from 
sources such as trash; and
    (3) During holding, human food by-products for use as animal food 
must be accurately identified.
    (b) Labeling that identifies the product by the common or usual name 
must be affixed to or accompany the human food by-products for use as 
animal food when distributed.
    (c) Shipping containers (e.g., totes, drums, and tubs) and bulk 
vehicles used to distribute human food by-products for use as animal 
food must be examined prior to use to protect against the contamination 
of animal food from the container or vehicle when the facility is 
responsible for transporting the human food by-products for use as 
animal food itself or arranges with a third party to transport the human 
food by-products for use as animal food.



      Subpart C_Hazard Analysis and Risk-Based Preventive Controls



Sec. 507.31  Food safety plan.

    (a) You must prepare, or have prepared, and implement a written food 
safety plan.
    (b) One or more preventive controls qualified individuals must 
prepare, or oversee the preparation of, the food safety plan.

[[Page 48]]

    (c) The written food safety plan must include:
    (1) The written hazard analysis as required by Sec. 507.33(a)(2);
    (2) The written preventive controls as required by Sec. 507.34(b);
    (3) The written supply-chain program as required by subpart E of 
this part;
    (4) The written recall plan as required by Sec. 507.38(a)(1);
    (5) The written procedures for monitoring the implementation of the 
preventive controls as required by Sec. 507.40(a);
    (6) The written corrective action procedures as required by Sec. 
507.42(a)(1); and
    (7) The written verification procedures as required by Sec. 
507.49(b).
    (d) The food safety plan required by this section is a record that 
is subject to the requirements of subpart F of this part.

[80 FR 56337, Sept. 17, 2015, as amended at 84 FR 12491, Apr. 2, 2019]



Sec. 507.33  Hazard analysis.

    (a)(1) You must conduct a hazard analysis to identify and evaluate, 
based on experience, illness data, scientific reports, and other 
information, known or reasonably foreseeable hazards for each type of 
animal food manufactured, processed, packed, or held at your facility to 
determine whether there are any hazards requiring a preventive control; 
and
    (2) The hazard analysis must be written regardless of its outcome.
    (b) The hazard identification must consider:
    (1) Known or reasonably foreseeable hazards that include:
    (i) Biological hazards, including microbiological hazards such as 
parasites, environmental pathogens, and other pathogens;
    (ii) Chemical hazards, including radiological hazards, substances 
such as pesticide and drug residues, natural toxins, decomposition, 
unapproved food or color additives, and nutrient deficiencies or 
toxicities (such as inadequate thiamine in cat food, excessive vitamin D 
in dog food, and excessive copper in food for sheep); and
    (iii) Physical hazards (such as stones, glass, and metal fragments); 
and
    (2) Known or reasonably foreseeable hazards that may be present in 
the animal food for any of the following reasons:
    (i) The hazard occurs naturally;
    (ii) The hazard may be unintentionally introduced; or
    (iii) The hazard may be intentionally introduced for purposes of 
economic gain.
    (c)(1) The hazard analysis must include an evaluation of the hazards 
identified in paragraph (b) of this section to assess the severity of 
the illness or injury to humans or animals if the hazard were to occur 
and the probability that the hazard will occur in the absence of 
preventive controls.
    (2) The hazard evaluation required by paragraph (c)(1) of this 
section must include an evaluation of environmental pathogens whenever 
an animal food is exposed to the environment prior to packaging and the 
packaged animal food does not receive a treatment or otherwise include a 
control measure (such as a formulation lethal to the pathogen) that 
would significantly minimize the pathogen.
    (d) The hazard evaluation must consider the effect of the following 
on the safety of the finished animal food for the intended animal:
    (1) The formulation of the animal food;
    (2) The condition, function, and design of the facility and 
equipment;
    (3) Raw materials and other ingredients;
    (4) Transportation practices;
    (5) Manufacturing/processing procedures;
    (6) Packaging activities and labeling activities;
    (7) Storage and distribution;
    (8) Intended or reasonably foreseeable use;
    (9) Sanitation, including employee hygiene; and
    (10) Any other relevant factors such as the temporal (e.g., weather-
related) nature of some hazards (e.g., levels of some natural toxins).

[80 FR 56337, Sept. 17, 2015, as amended at 81 FR 3717, Jan. 22, 2016]



Sec. 507.34  Preventive controls.

    (a)(1) You must identify and implement preventive controls to 
provide assurances that any hazards requiring a preventive control will 
be significantly

[[Page 49]]

minimized or prevented and the animal food manufactured, processed, 
packed, or held by your facility will not be adulterated under section 
402 of the Federal Food, Drug, and Cosmetic Act; and
    (2) Preventive controls required by paragraph (a)(1) of this section 
include:
    (i) Controls at critical control points (CCPs), if there are any 
CCPs; and
    (ii) Controls, other than those at CCPs, that are also appropriate 
for animal food safety.
    (b) Preventive controls must be written.
    (c) Preventive controls include, as appropriate to the facility and 
animal food:
    (1) Process controls. Process controls include procedures, 
practices, and processes to ensure the control of parameters during 
operations such as heat processing, irradiating, and refrigerating 
animal food. Process controls must include, as appropriate to the nature 
of the applicable control and its role in the facility's food safety 
system:
    (i) Parameters associated with the control of the hazard; and
    (ii) The maximum or minimum value, or combination of values, to 
which any biological, chemical, or physical parameter must be controlled 
to significantly minimize or prevent a hazard requiring a process 
control.
    (2) Sanitation controls. Sanitation controls include procedures, 
practices, and processes to ensure that the facility is maintained in a 
sanitary condition adequate to significantly minimize or prevent hazards 
such as environmental pathogens and biological hazards due to employee 
handling. Sanitation controls must include, as appropriate to the 
facility and the animal food, procedures, practices, and processes for 
the:
    (i) Cleanliness of animal food-contact surfaces, including animal 
food-contact surfaces of utensils and equipment; and
    (ii) Prevention of cross-contamination from insanitary objects and 
from personnel to animal food, animal food-packaging material, and other 
animal food-contact surfaces and from raw product to processed product.
    (3) Supply-chain controls. Supply-chain controls include the supply-
chain program as required by subpart E of this part;
    (4) A recall plan as required by Sec. 507.38; and
    (5) Other preventive controls. These include any other procedures, 
practices, and processes necessary to satisfy the requirements of 
paragraph (a) of this section. Examples of other controls include 
hygiene training and other current good manufacturing practices.



Sec. 507.36  Circumstances in which the owner, operator, or agent
in charge of a manufacturing/processing facility is not required 
to implement a preventive control.
          

    (a) If you are a manufacturer/processor, you are not required to 
implement a preventive control when you identify a hazard requiring a 
preventive control (identified hazard) and any of the following 
circumstances apply:
    (1) You determine and document that the type of animal food could 
not be consumed without application of an appropriate control;
    (2) You rely on your customer who is subject to the requirements for 
hazard analysis and risk-based preventive controls in this subpart to 
ensure that the identified hazard will be significantly minimized or 
prevented; and you:
    (i) Disclose in documents accompanying the animal food, in 
accordance with the practice of the trade, that the animal food is ``not 
processed to control [identified hazard]''; and
    (ii) Annually obtain from your customer written assurance, subject 
to the requirements of Sec. 507.37, that the customer has established 
and is following procedures (identified in the written assurance) that 
will significantly minimize or prevent the identified hazard (except as 
provided in paragraph (c) of this section);
    (3) You rely on your customer who is not subject to the requirements 
for hazard analysis and risk-based preventive controls in this subpart 
to provide assurance it is manufacturing, processing, or preparing the 
animal food in accordance with applicable animal food safety 
requirements and you:
    (i) Disclose in documents accompanying the animal food, in 
accordance with the practice of the trade, that the

[[Page 50]]

animal food is ``not processed to control [identified hazard]''; and
    (ii) Annually obtain from your customer written assurance that it is 
manufacturing, processing, or preparing the animal food in accordance 
with applicable animal food safety requirements;
    (4) You rely on your customer to provide assurance that the animal 
food will be processed to control the identified hazard by an entity in 
the distribution chain subsequent to the customer and you:
    (i) Disclose in documents accompanying the animal food, in 
accordance with the practice of the trade, that the animal food is ``not 
processed to control [identified hazard]''; and
    (ii) Annually obtain from your customer written assurance, subject 
to the requirements of Sec. 507.37, that your customer:
    (A) Will disclose in documents accompanying the animal food, in 
accordance with the practice of the trade, that the animal food is ``not 
processed to control [identified hazard]''; and
    (B) Will only sell to another entity that agrees, in writing, it 
will:
    (1) Follow procedures (identified in a written assurance) that will 
significantly minimize or prevent the identified hazard (if the entity 
is subject to the requirements for hazard analysis and risk-based 
preventive controls in subpart C of this part), except as provided in 
paragraph (d) of this section, or manufacture, process, or prepare the 
animal food in accordance with applicable animal food safety 
requirements (if the entity is not subject to the requirements for 
hazard analysis and risk-based preventive controls in subpart C of this 
part); or
    (2) Obtain a similar written assurance from the entity's customer, 
subject to the requirements of Sec. 507.37, as in paragraphs 
(a)(4)(ii)(A) and (B) of this section, as appropriate; or
    (5) You have established, documented, and implemented a system that 
ensures control, at a subsequent distribution step, of the hazards in 
the animal food you distribute and you document the implementation of 
that system.
    (b) You must document any circumstance specified in paragraph (a) of 
this section that applies to you, including:
    (1) A determination in accordance with paragraph (a) of this section 
that the type of animal food could not be consumed without application 
of an appropriate control;
    (2) The annual written assurance from your customer in accordance 
with paragraph (a)(2) of this section;
    (3) The annual written assurance from your customer in accordance 
with paragraph (a)(3) of this section;
    (4) The annual written assurance from your customer in accordance 
with paragraph (a)(4) of this section; and
    (5) Your system, in accordance with paragraph (a)(5) of this 
section, that ensures control, at a subsequent distribution step, of the 
hazards in the animal food you distribute.
    (c) For the written assurance required by paragraph (a)(2)(ii) of 
this section, if your customer has determined that the identified hazard 
in paragraph (a) of this section is not a hazard in the animal food 
intended for use for a specific animal species, your customer's written 
assurance may provide this determination (including animal species and 
why the identified hazard is not a hazard) instead of providing 
assurance of procedures established and followed that will significantly 
minimize or prevent the identified hazard.
    (d) For the written assurance required by paragraph (a)(4)(ii)(B) of 
this section, if the entity in the distribution chain subsequent to your 
customer is subject to subpart C of this part and has determined that 
the identified hazard in paragraph (a) of this section is not a hazard 
in the animal food intended for use for a specific animal species, that 
entity's written assurance may provide this determination (including 
animal species and why the identified hazard is not a hazard) instead of 
providing assurance that the identified hazard will be significantly 
minimized or prevented.

[80 FR 56337, Sept. 17, 2015, as amended at 81 FR 3717, Jan. 22, 2016]

[[Page 51]]



Sec. 507.37  Provision of assurances required under Sec. 507.36(a)
(2), (3), and (4).

    A facility that provides a written assurance under Sec. 
507.36(a)(2), (3), or (4) must act consistently with the assurance and 
document its actions taken to satisfy the written assurance.



Sec. 507.38  Recall plan.

    (a) For animal food with a hazard requiring a preventive control you 
must:
    (1) Establish a written recall plan for the animal food; and
    (2) Assign responsibility for performing all procedures in the 
recall plan.
    (b) The written recall plan must include procedures that describe 
the steps to perform the following actions as appropriate to the 
facility:
    (1) Directly notify direct consignees about the animal food being 
recalled, including how to return or dispose of the affected animal 
food;
    (2) Notify the public about any hazard presented by the animal food 
when appropriate to protect human and animal health;
    (3) Conduct effectiveness checks to verify the recall has been 
carried out; and
    (4) Appropriately dispose of recalled animal food, e.g., through 
reprocessing, reworking, diverting to another use that would not present 
a safety concern, or destroying the animal food.



Sec. 507.39  Preventive control management components.

    (a) Except as provided by paragraphs (b) and (c) of this section, 
the preventive controls required under Sec. 507.34 are subject to the 
following preventive control management components as appropriate to 
ensure the effectiveness of the preventive controls, taking into account 
the nature of the preventive control and its role in the facility's food 
safety system:
    (1) Monitoring in accordance with Sec. 507.40;
    (2) Corrective actions and corrections in accordance with Sec. 
507.42; and
    (3) Verification in accordance with Sec. 507.45.
    (b) The supply-chain program established in subpart E of this part 
is subject to the following preventive control management components as 
appropriate to ensure the effectiveness of the supply-chain program, 
taking into account the nature of the hazard controlled before receipt 
of the raw material or other ingredient:
    (1) Corrective actions and corrections in accordance with Sec. 
507.42, taking into account the nature of any supplier non-conformance;
    (2) Review of records in accordance with Sec. 507.49(a)(4)(ii); and
    (3) Reanalysis in accordance with Sec. 507.50.
    (c) The recall plan established in Sec. 507.38 is not subject to 
the requirements of paragraph (a) of this section.



Sec. 507.40  Monitoring.

    As appropriate to the nature of the preventive control and its role 
in the facility's food safety system you must:
    (a) Establish and implement written procedures, including the 
frequency with which they are to be performed, for monitoring the 
preventive controls; and
    (b) Monitor the preventive controls with adequate frequency to 
provide assurance that they are consistently performed.
    (c)(1) You must document the monitoring of preventive controls in 
accordance with this section in records that are subject to verification 
in accordance with Sec. 507.45(a)(2) and records review in accordance 
with Sec. 507.49(a)(4)(i);
    (2)(i) Records of refrigeration temperature during storage of animal 
food that requires time/temperature control to significantly minimize or 
prevent the growth of, or toxin production by, pathogens may be 
affirmative records demonstrating temperature is controlled or exception 
records demonstrating loss of temperature control; and
    (ii) Exception records may be adequate in circumstances other than 
monitoring of refrigeration temperature.



Sec. 507.42  Corrective actions and corrections.

    (a) As appropriate to the nature of the hazard and the nature of the 
preventive control, except as provided by paragraph (c) of this section:

[[Page 52]]

    (1) You must establish and implement written corrective action 
procedures that must be taken if preventive controls are not properly 
implemented, including procedures to address, as appropriate:
    (i) The presence of a pathogen or appropriate indicator organism in 
animal food detected as a result of product testing conducted in 
accordance with Sec. 507.49(a)(2); and
    (ii) The presence of an environmental pathogen or appropriate 
indicator organism detected through the environmental monitoring 
conducted in accordance with Sec. 507.49(a)(3).
    (2) The corrective action procedures must describe the steps to be 
taken to ensure that:
    (i) Appropriate action is taken to identify and correct a problem 
that has occurred with implementation of a preventive control;
    (ii) Appropriate action is taken when necessary, to reduce the 
likelihood that the problem will recur;
    (iii) All affected animal food is evaluated for safety; and
    (iv) All affected animal food is prevented from entering into 
commerce if you cannot ensure the affected animal food is not 
adulterated under section 402 of the Federal Food, Drug, and Cosmetic 
Act.
    (b)(1) Except as provided by paragraph (c) of this section, you are 
subject to the requirements of paragraph (b)(2) of this section if any 
of the following circumstances apply:
    (i) A preventive control is not properly implemented and a 
corrective action procedure has not been established;
    (ii) A preventive control, combination of preventive controls, or 
the food safety plan as a whole is found to be ineffective; or
    (iii) A review of records in accordance with Sec. 507.49(a)(4) 
finds that the records are not complete, the activities conducted did 
not occur in accordance with the food safety plan, or appropriate 
decisions were not made about corrective actions.
    (2) If any of the circumstances listed in paragraph (b)(1) of this 
section apply, you must:
    (i) Take corrective action to identify and correct the problem;
    (ii) Reduce the likelihood that the problem will recur;
    (iii) Evaluate all affected animal food for safety;
    (iv) As necessary, prevent affected animal food from entering 
commerce as would be done following the corrective action procedure 
under paragraph (a)(2) of this section; and
    (v) When appropriate, reanalyze the food safety plan in accordance 
with Sec. 507.50 to determine whether modification of the food safety 
plan is required.
    (c) You do not need to comply with the requirements of paragraphs 
(a) and (b) of this section if:
    (1) You take action, in a timely manner, to identify and correct 
conditions and practices that are not consistent with the sanitation 
controls in Sec. 507.34(c)(2)(i) or (ii); or
    (2) You take action, in a timely manner, to identify and correct a 
minor and isolated problem that does not directly impact product safety.
    (d) All corrective actions (and, when appropriate, corrections) 
taken in accordance with this section must be documented in records. 
These records are subject to verification in accordance with Sec. 
507.45(a)(3) and records review in accordance with Sec. 
507.49(a)(4)(i).



Sec. 507.45  Verification.

    (a) Verification activities must include, as appropriate to the 
nature of the preventive control and its role in the facility's food 
safety system:
    (1) Validation in accordance with Sec. 507.47;
    (2) Verification that monitoring is being conducted as required by 
Sec. 507.39 (and in accordance with Sec. 507.40);
    (3) Verification that appropriate decisions about corrective actions 
are being made as required by Sec. 507.39 (and in accordance with Sec. 
507.42);
    (4) Verification of implementation and effectiveness in accordance 
with Sec. 507.49; and
    (5) Reanalysis in accordance with Sec. 507.50.
    (b) All verification activities conducted in accordance with this 
section must be documented in records.

[[Page 53]]



Sec. 507.47  Validation.

    (a) You must validate that the preventive controls identified and 
implemented in accordance with Sec. 507.34 are adequate to control the 
hazard as appropriate to the nature of the preventive control and its 
role in the facility's food safety system.
    (b) The validation of the preventive controls:
    (1) Must be performed (or overseen) by a preventive controls 
qualified individual:
    (i)(A) Prior to implementation of the food safety plan; or
    (B) When necessary to demonstrate the control measures can be 
implemented as designed:
    (1) Within 90 calendar days after production of the applicable 
animal food first begins; or
    (2) Within a reasonable timeframe, provided that the preventive 
controls qualified individual prepares (or oversees the preparation of) 
a written justification for a timeframe that exceeds 90 calendar days 
after production of the applicable animal food first begins;
    (ii) Whenever a change to a control measure or combination of 
control measures could impact whether the control measure or combination 
of control measures, when properly implemented, will effectively control 
the hazards; and
    (iii) Whenever a reanalysis of the food safety plan reveals the need 
to do so.
    (2) Must include obtaining and evaluating scientific and technical 
evidence (or, when such evidence is not available or is inadequate, 
conducting studies) to determine whether the preventive controls, when 
properly implemented, will effectively control the hazards.
    (c) You do not need to validate:
    (1) The sanitation controls in Sec. 507.34(c)(2);
    (2) The recall plan in Sec. 507.38;
    (3) The supply-chain program in subpart E of this part; and
    (4) Other preventive controls, if the preventive controls qualified 
individual prepares (or oversees the preparation of) a written 
justification that validation is not applicable based on factors such as 
the nature of the hazard, and the nature of the preventive control and 
its role in the facility's food safety system.

[80 FR 56337, Sept. 17, 2015, as amended at 81 FR 3718, Jan. 22, 2016]



Sec. 507.49  Verification of implementation and effectiveness.

    (a) You must verify that the preventive controls are consistently 
implemented and are effectively and significantly minimizing or 
preventing the hazards. To do so, you must conduct activities that 
include the following, as appropriate to the facility, the animal food, 
and the nature of the preventive control and its role in the facility's 
food safety system:
    (1) Calibration of process monitoring and verification instruments 
(or checking them for accuracy);
    (2) Product testing for a pathogen (or appropriate indicator 
organism) or other hazard;
    (3) Environmental monitoring, for an environmental pathogen or for 
an appropriate indicator organism, if contamination of an animal food 
with an environmental pathogen is a hazard requiring a preventive 
control, by collecting and testing environmental samples; and
    (4) Review of the following records within the specified timeframes, 
by (or under the oversight of) a preventive controls qualified 
individual, to ensure the records are complete, the activities reflected 
in the records occurred in accordance with the food safety plan, the 
preventive controls are effective, and appropriate decisions were made 
about corrective actions:
    (i) Monitoring and corrective action records within 7-working days 
after the records are created or within a reasonable timeframe, provided 
that the preventive controls qualified individual prepares (or oversees 
the preparation of) a written justification for a timeframe that exceeds 
7-working days; and
    (ii) Records of calibration, testing (e.g., product testing, 
environmental monitoring), and supplier and supply-chain verification 
activities, and other verification activities within a reasonable time 
after the records are created; and
    (5) Other activities appropriate for verification of implementation 
and effectiveness.

[[Page 54]]

    (b) As appropriate to the facility, the food, the nature of the 
preventive control, and the role of the preventive control in the 
facility's food safety system, you must establish and implement written 
procedures for the following activities:
    (1) The method and frequency of calibrating process monitoring 
instruments and verification instruments (or checking them for accuracy) 
as required by paragraph (a)(1) of this section;
    (2) Product testing as required by paragraph (a)(2) of this section. 
Procedures for product testing must:
    (i) Be scientifically valid;
    (ii) Identify the test microorganism(s) or other analyte(s);
    (iii) Specify the procedures for identifying samples, including 
their relationship to specific lots of product;
    (iv) Include the procedures for sampling, including the number of 
samples and the sampling frequency;
    (v) Identify the test(s) conducted, including the analytical 
method(s) used;
    (vi) Identify the laboratory conducting the testing; and
    (vii) Include the corrective action procedures required by Sec. 
507.42(a)(1).
    (3) Environmental monitoring as required by paragraph (a)(3) of this 
section. Procedures for environmental monitoring must:
    (i) Be scientifically valid;
    (ii) Identify the test microorganism(s);
    (iii) Identify the locations from which samples will be collected 
and the number of sites to be tested during routine environmental 
monitoring. The number and location of sampling sites must be adequate 
to determine whether preventive controls are effective;
    (iv) Identify the timing and frequency for collecting and testing 
samples. The timing and frequency for collecting and testing samples 
must be adequate to determine whether preventive controls are effective;
    (v) Identify the test(s) conducted, including the analytical 
method(s) used;
    (vi) Identify the laboratory conducting the testing; and
    (vii) Include the corrective action procedures required by Sec. 
507.42(a)(1)(ii).



Sec. 507.50  Reanalysis.

    (a) You must conduct a reanalysis of the food safety plan as a whole 
at least once every 3 years.
    (b) You must conduct a reanalysis of the food safety plan as a 
whole, or the applicable portion of the food safety plan:
    (1) Whenever a significant change in the activities conducted at 
your facility creates a reasonable potential for a new hazard or creates 
a significant increase in a previously identified hazard;
    (2) Whenever you become aware of new information about potential 
hazards associated with the animal food;
    (3) Whenever appropriate after an unanticipated animal food safety 
problem in accordance with Sec. 507.42(b); and
    (4) Whenever you find that a preventive control, combination of 
preventive controls, or the food safety plan as a whole is ineffective.
    (c) You must complete the reanalysis required by paragraphs (a) and 
(b) of this section and validate, as appropriate to the nature of the 
preventive control and its role in the facility's food safety system, 
any additional preventive controls needed to address the hazard 
identified:
    (1) Before any change in activities (including any change in 
preventive control) at the facility is operative; or
    (2) When necessary to demonstrate the control measures can be 
implemented as designed:
    (i) Within 90 calendar days after production of the applicable 
animal food first begins; or
    (ii) Within a reasonable timeframe, provided that the preventive 
controls qualified individual prepares (or oversees the preparation of) 
a written justification for a timeframe that exceeds 90 calendar days 
after production of the applicable animal food first begins.
    (d) You must revise the written food safety plan if a significant 
change in the activities conducted at your facility creates a reasonable 
potential for a new hazard or a significant increase in a previously 
identified hazard, or document the basis for the conclusion that no 
revisions are needed.
    (e) A preventive controls qualified individual must perform (or 
oversee) the reanalysis.

[[Page 55]]

    (f) You must conduct a reanalysis of the food safety plan when FDA 
determines it is necessary to respond to new hazards and developments in 
scientific understanding.

[80 FR 56337, Sept. 17, 2015, as amended at 81 FR 3718, Jan. 22, 2016]



Sec. 507.51  Modified requirements that apply to a facility solely 
engaged in the storage of unexposed packaged animal food.

    (a) If a facility that is solely engaged in the storage of unexposed 
packaged animal food stores any such refrigerated packaged animal food 
that requires time/temperature control to significantly minimize or 
prevent the growth of, or toxin formation by pathogens, the facility 
must conduct the following activities as appropriate to ensure the 
effectiveness of the temperature controls:
    (1) Establish and implement temperature controls adequate to 
significantly minimize or prevent the growth of, or toxin formation by, 
pathogens;
    (2) Monitor the temperature controls with adequate frequency to 
provide assurance that the temperature controls are consistently 
performed;
    (3) If there is a loss of temperature control that may impact the 
safety of such refrigerated packaged animal food, take appropriate 
corrective actions to:
    (i) Correct the problem and reduce the likelihood that the problem 
will recur;
    (ii) Evaluate all affected animal food for safety; and
    (iii) Prevent the animal food from entering commerce, if you cannot 
ensure the affected animal food is not adulterated under section 402 of 
the Federal Food, Drug, and Cosmetic Act;
    (4) Verify that temperature controls are consistently implemented 
by:
    (i) Calibrating temperature monitoring and recording devices (or 
checking them for accuracy);
    (ii) Reviewing records of calibration within a reasonable time after 
the records are created; and
    (iii) Reviewing records of monitoring and corrective actions taken 
to correct a problem with the control of temperature within 7-working 
days after the records are created or within a reasonable timeframe, 
provided that the preventive controls qualified individual prepares (or 
oversees the preparation of) a written justification for a timeframe 
that exceeds 7-working days; and
    (5) Establish and maintain the following records:
    (i) Records (whether affirmative records demonstrating temperature 
is controlled or exception records demonstrating loss of temperature 
control) documenting the monitoring of temperature controls for any such 
refrigerated packaged animal food;
    (ii) Records of corrective actions taken when there is a loss of 
temperature control that may impact the safety of any such refrigerated 
packaged animal food; and
    (iii) Records documenting the verification activities.
    (b) The records that a facility must establish and maintain under 
paragraph (a)(5) of this section are subject to the requirements of 
subpart F of this part.

[80 FR 56337, Sept. 17, 2015, as amended at 81 FR 3718, Jan. 22, 2016]



Sec. 507.53  Requirements applicable to a preventive controls 
qualified individual and a qualified auditor.

    (a) One or more preventive controls qualified individuals must do or 
oversee the following:
    (1) Preparation of the food safety plan (Sec. 507.31(b));
    (2) Validation of the preventive controls (Sec. 507.47(b)(1));
    (3) Written justification for validation to be performed in a 
timeframe that exceeds the first 90 calendar days of production of the 
applicable animal food;
    (4) Determination that validation is not required (Sec. 
507.47(c)(4));
    (5) Review of records (Sec. 507.49(a)(4));
    (6) Written justification for review of records of monitoring and 
corrective actions within a timeframe that exceeds 7-working days;
    (7) Reanalysis of the food safety plan (Sec. 507.50(d)); and
    (8) Determination that reanalysis can be completed, and additional 
preventive controls validated, as appropriate to the nature of the 
preventive control and its role in the facility's food safety system, in 
a timeframe that exceeds

[[Page 56]]

the first 90 calendar days of production of the applicable animal food.
    (b) A qualified auditor must conduct an onsite audit (Sec. 
507.135(a)).
    (c)(1) To be a preventive controls qualified individual, the 
individual must have successfully completed training in the development 
and application of risk-based preventive controls at least equivalent to 
that received under a standardized curriculum recognized as adequate by 
FDA or be otherwise qualified through job experience to develop and 
apply a food safety system. Job experience may qualify an individual to 
perform these functions if such experience has provided an individual 
with knowledge at least equivalent to that provided through the 
standardized curriculum. This individual may be, but is not required to 
be, an employee of the facility; and
    (2) To be a qualified auditor, a qualified individual must have 
technical expertise obtained through education, training, or experience 
(or a combination thereof) necessary to perform the auditing function.
    (d) All applicable training in the development and application of 
risk-based preventive controls must be documented in records, including 
the date of the training, the type of training, and the person(s) 
trained.



Sec. 507.55  Implementation records required for this subpart.

    (a) You must establish and maintain the following records 
documenting implementation of the food safety plan:
    (1) Documentation, as required by Sec. 507.36(b), of the basis for 
not establishing a preventive control in accordance with Sec. 
507.36(a);
    (2) Records that document the monitoring of preventive controls;
    (3) Records that document corrective actions;
    (4) Records that document verification, including, as applicable, 
those related to:
    (i) Validation;
    (ii) Verification of monitoring;
    (iii) Verification of corrective actions;
    (iv) Calibration of process monitoring and verification instruments;
    (v) Product testing;
    (vi) Environmental monitoring;
    (vii) Records review; and
    (viii) Reanalysis;
    (5) Records that document the supply-chain program; and
    (6) Records that document applicable training for the preventive 
controls qualified individual and the qualified auditor.
    (b) The records that you must establish and maintain are subject to 
the requirements of subpart F of this part.



         Subpart D_Withdrawal of a Qualified Facility Exemption



Sec. 507.60  Circumstances that may lead FDA to withdraw a qualified
facility exemption.

    (a) FDA may withdraw a qualified facility exemption under Sec. 
507.5(d):
    (1) In the event of an active investigation of a foodborne illness 
outbreak that is directly linked to the qualified facility; or
    (2) If FDA determines that it is necessary to protect the public 
(human or animal) health and prevent or mitigate a foodborne illness 
outbreak based on conditions or conduct associated with the qualified 
facility that are material to the safety of the animal food 
manufactured, processed, packed, or held at such facility.
    (b) Before FDA issues an order to withdraw a qualified facility 
exemption, FDA:
    (1) May consider one or more other actions to protect the public 
(human or animal) health or mitigate a foodborne illness outbreak, 
including, a warning letter, recall, administrative detention, 
suspension of registration, refusal of animal food offered for import, 
seizure, and injunction;
    (2) Must notify the owner, operator, or agent in charge of the 
facility, in writing of circumstances that may lead FDA to withdraw the 
exemption, and provide an opportunity for the owner, operator, or agent 
in charge of the facility to respond in writing, within 15 calendar days 
of the date of receipt of the notification, to FDA's notification; and
    (3) Must consider the actions taken by the facility to address the 
circumstances that may lead FDA to withdraw the exemption.

[[Page 57]]



Sec. 507.62  Issuance of an order to withdraw a qualified facility
exemption.

    (a) An FDA Division Director in whose division the qualified 
facility is located (or, in the case of a foreign facility, the Director 
of the Division of Compliance in the Center for Veterinary Medicine), or 
an FDA official senior to either such Director, must approve an order to 
withdraw the exemption before the order is issued.
    (b) Any officer or qualified employee of FDA may issue an order to 
withdraw the exemption after it has been approved in accordance with 
paragraph (a) of this section.
    (c) FDA must issue an order to withdraw the exemption to the owner, 
operator, or agent in charge of the facility.
    (d) FDA must issue an order to withdraw the exemption in writing, 
signed and dated by the officer or qualified employee of FDA who is 
issuing the order.

[80 FR 56337, Sept. 17, 2015, as amended at 85 FR 16554, Mar. 24, 2020]



Sec. 507.65  Contents of an order to withdraw a qualified facility exemption.

    An order to withdraw a qualified facility exemption under Sec. 
507.5(d) must include the following information:
    (a) The date of the order;
    (b) The name, address, and location of the qualified facility;
    (c) A brief, general statement of the reasons for the order, 
including information relevant to one or both of the following 
circumstances that leads FDA to issue the order:
    (1) An active investigation of a foodborne illness outbreak that is 
directly linked to the facility; or
    (2) Conditions or conduct associated with a qualified facility that 
are material to the safety of the animal food manufactured, processed, 
packed, or held at such facility.
    (d) A statement that the facility must either:
    (1) Comply with subparts C and E of this part on the date that is 
120 calendar days after the date of receipt of the order or within a 
reasonable timeframe, agreed to by FDA, based on a written 
justification, submitted to FDA, for a timeframe that exceeds 120 
calendar days from the date of receipt of the order; or
    (2) Appeal the order within 15 calendar days of the date of receipt 
of the order in accordance with the requirements of Sec. 507.69.
    (e) A statement that a facility may request that FDA reinstate an 
exemption that was withdrawn by following the procedures in Sec. 
507.85;
    (f) The text of section 418(l) of the Federal Food, Drug, and 
Cosmetic Act and of this subpart;
    (g) A statement that any informal hearing on an appeal of the order 
must be conducted as a regulatory hearing under part 16 of this chapter, 
with certain exceptions described in Sec. 507.73;
    (h) The mailing address, telephone number, email address, fax 
number, and name of the FDA Division Director in whose division the 
facility is located (or, in the case of a foreign facility, the same 
information for the Director of the Division of Compliance in the Center 
for Veterinary Medicine); and
    (i) The name and the title of the FDA representative who approved 
the order.

[80 FR 56337, Sept. 17, 2015, as amended at 81 FR 3718, Jan. 22, 2016; 
85 FR 16554, Mar. 24, 2020]



Sec. 507.67  Compliance with, or appeal of, an order to withdraw
a qualified facility exemption.

    (a) If you receive an order under Sec. 507.65 to withdraw a 
qualified facility exemption, you must either:
    (1) Comply with applicable requirements of this part within 120 
calendar days of the date of receipt of the order, or within a 
reasonable timeframe, agreed to by FDA, based on a written 
justification, submitted to FDA, for a timeframe that exceeds 120 
calendar days from the date of receipt of the order; or
    (2) Appeal the order within 15 calendar days of the date of receipt 
of the order in accordance with the requirements of Sec. 507.69.
    (b) Submission of an appeal, including submission of a request for 
an informal hearing, will not operate to delay or stay any 
administrative action, including enforcement action by FDA, unless the 
Commissioner of Food and Drugs, as a matter of discretion, determines 
that delay or a stay is in the public interest.

[[Page 58]]

    (c) If you appeal the order, and FDA confirms the order:
    (1) You must comply with applicable requirements of this part within 
120 calendar days of the date of receipt of the order, or within a 
reasonable timeframe, agreed to by FDA, based on a written 
justification, submitted to FDA, for a timeframe that exceeds 120 
calendar days from the date of receipt of the order; and
    (2) You are no longer subject to the requirements in Sec. 507.7.



Sec. 507.69  Procedure for submitting an appeal.

    (a) To appeal an order to withdraw a qualified facility exemption, 
you must:
    (1) Submit the appeal in writing to the FDA Division Director in 
whose division the facility is located (or, in the case of a foreign 
facility, the Director of the Division of Compliance in the Center for 
Veterinary Medicine), at the mailing address, email address, or fax 
number identified in the order within 15 calendar days of the date of 
receipt of confirmation of the order; and
    (2) Respond with particularity to the facts and issues contained in 
the order, including any supporting documentation upon which you rely.
    (b) In a written appeal of the order withdrawing an exemption 
provided under Sec. 507.5(d), you may include a written request for an 
informal hearing as provided in Sec. 507.71.

[80 FR 56337, Sept. 17, 2015, as amended at 81 FR 3718, Jan. 22, 2016; 
85 FR 16554, Mar. 24, 2020]



Sec. 507.71  Procedure for requesting an informal hearing.

    (a) If you appeal the order, you:
    (1) May request an informal hearing; and
    (2) Must submit any request for an informal hearing together with 
your written appeal submitted in accordance with Sec. 507.69 within 15 
calendar days of the date of receipt of the order.
    (b) A request for an informal hearing may be denied, in whole or in 
part, if the presiding officer determines that no genuine and 
substantial issue of material fact has been raised by the material 
submitted. If the presiding officer determines that a hearing is not 
justified, written notice of the determination will be given to you 
explaining the reason for the denial.



Sec. 507.73  Requirements applicable to an informal hearing.

    If you request an informal hearing, and FDA grants the request:
    (a) The hearing will be held within 15 calendar days after the date 
the appeal is filed or, if applicable, within a timeframe agreed upon in 
writing by you and FDA.
    (b) The presiding officer may require that a hearing conducted under 
this subpart be completed within 1 calendar day, as appropriate.
    (c) FDA must conduct the hearing in accordance with part 16 of this 
chapter, except that:
    (1) The order withdrawing an exemption under Sec. Sec. 507.62 and 
507.65, rather than the notice under Sec. 16.22(a) of this chapter, 
provides notice of opportunity for a hearing under this section and is 
part of the administrative record of the regulatory hearing under Sec. 
16.80(a) of this chapter.
    (2) A request for a hearing under this subpart must be addressed to 
the FDA Division Director (or, in the case of a foreign facility, the 
Director of the Division of Compliance in the Center for Veterinary 
Medicine) as provided in the order withdrawing an exemption.
    (3) Section 507.75, rather than Sec. 16.42(a) of this chapter, 
describes the FDA employees who preside at hearings under this subpart.
    (4) Section 16.60(e) and (f) of this chapter does not apply to a 
hearing under this subpart. The presiding officer must prepare a written 
report of the hearing. All written material presented at the hearing 
will be attached to the report. The presiding officer must include as 
part of the report of the hearing a finding on the credibility of 
witnesses (other than expert witnesses) whenever credibility is a 
material issue, and must include a proposed decision, with a statement 
of reasons. The hearing participant may review and comment on the 
presiding officer's report within 2 calendar days of issuance of the 
report. The presiding officer will then issue the final decision.
    (5) Section 16.80(a)(4) of this chapter does not apply to a 
regulatory hearing

[[Page 59]]

under this subpart. The presiding officer's report of the hearing and 
any comments on the report by the hearing participant under paragraph 
(c)(4) of this section are part of the administrative record.
    (6) No party shall have the right, under Sec. 16.119 of this 
chapter to petition the Commissioner of Food and Drugs for 
reconsideration or a stay of the presiding officer's final decision.
    (7) If FDA grants a request for an informal hearing on an appeal of 
an order withdrawing an exemption, the hearing must be conducted as a 
regulatory hearing under a regulation in accordance with part 16 of this 
chapter, except that Sec. 16.95(b) does not apply to a hearing under 
this subpart. With respect to a regulatory hearing under this subpart, 
the administrative record of the hearing specified in Sec. Sec. 
16.80(a)(1) through (3), and (a)(5), of this chapter, and 507.73(c)(5) 
constitutes the exclusive record for the presiding officer's final 
decision. For purposes of judicial review under Sec. 10.45 of this 
chapter, the record of the administrative proceeding consists of the 
record of the hearing and the presiding officer's final decision.

[80 FR 56337, Sept. 17, 2015, as amended at 85 FR 16554, Mar. 24, 2020]



Sec. 507.75  Presiding officer for an appeal and for an informal
hearing.

    The presiding officer for an appeal, and for an informal hearing, 
must be an Office of Regulatory Affairs Program Director or another FDA 
official senior to an FDA Division Director.

[85 FR 16555, Mar. 24, 2020]



Sec. 507.77  Timeframe for issuing a decision on an appeal.

    (a) If you appeal the order without requesting a hearing, the 
presiding officer must issue a written report that includes a final 
decision confirming or revoking the withdrawal by the 10th calendar day 
after the appeal is filed.
    (b) If you appeal the order and request an informal hearing:
    (1) If FDA grants the request for a hearing and the hearing is held, 
the presiding officer must provide a 2 calendar day opportunity for the 
hearing participants to review and submit comments on the report of the 
hearing under Sec. 507.73(c)(4), and must issue a final decision within 
10 calendar days after the hearing is held; or
    (2) If FDA denies the request for a hearing, the presiding officer 
must issue a final decision on the appeal confirming or revoking the 
withdrawal within 10 calendar days after the date the appeal is filed.



Sec. 507.80  Revocation of an order to withdraw a qualified facility
exemption.

    An order to withdraw a qualified facility exemption is revoked if:
    (a) You appeal the order and request an informal hearing, FDA grants 
the request for an informal hearing, and the presiding officer does not 
confirm the order within the 10 calendar days after the hearing, or 
issues a decision revoking the order within that time; or
    (b) You appeal the order and request an informal hearing, FDA denies 
the request for an informal hearing, and FDA does not confirm the order 
within the 10 calendar days after the appeal is filed, or issues a 
decision revoking the order within that time; or
    (c) You appeal the order without requesting an informal hearing, and 
FDA does not confirm the order within the 10 calendar days after the 
appeal is filed, or issues a decision revoking the order within that 
time.



Sec. 507.83  Final agency action.

    Confirmation of a withdrawal order by the presiding officer is 
considered a final agency action for purposes of 5 U.S.C. 702.



Sec. 507.85  Reinstatement of a qualified facility exemption that was
withdrawn.

    (a) If the FDA Division Director in whose division your facility is 
located (or, in the case of a foreign facility, the Director of the 
Division of Compliance in the Center for Veterinary Medicine) determines 
that a facility has adequately resolved any problems with the conditions 
and conduct that are material to the safety of the animal food 
manufactured, processed, packed, or held at the facility and that 
continued withdrawal of the exemption is not necessary to protect public 
(human and

[[Page 60]]

animal) health and prevent or mitigate a foodborne illness outbreak, the 
FDA Division Director in whose division your facility is located (or, in 
the case of a foreign facility, the Director of the Division of 
Compliance in the Center for Veterinary Medicine) will, on his or her 
own initiative or on the request of a facility, reinstate the exemption.
    (b) You may ask FDA to reinstate an exemption that has been 
withdrawn under the procedures of this subpart as follows:
    (1) Submit a request, in writing, to the FDA Division Director in 
whose division your facility is located (or, in the case of a foreign 
facility, the Director of the Division of Compliance in the Center for 
Veterinary Medicine); and
    (2) Present data and information to demonstrate that you have 
adequately resolved any problems with the conditions and conduct that 
are material to the safety of the animal food manufactured, processed, 
packed, or held at your facility, such that continued withdrawal of the 
exemption is not necessary to protect public (human and animal) health 
and prevent or mitigate a foodborne illness outbreak.
    (c) If your exemption was withdrawn under Sec. 507.60(a)(1) and FDA 
later determines, after finishing the active investigation of a 
foodborne illness outbreak, that the outbreak is not directly linked to 
your facility, FDA will reinstate your exemption under Sec. 507.5(d), 
and FDA will notify you in writing that your exempt status has been 
reinstated.
    (d) If your exemption was withdrawn under both Sec. 507.60(a)(1) 
and (2) and FDA later determines, after finishing the active 
investigation of a foodborne illness outbreak, that the outbreak is not 
directly linked to your facility, FDA will inform you of this finding 
and you may ask FDA to reinstate your exemption under Sec. 507.5(d) in 
accordance with the requirements of paragraph (b) of this section.

[80 FR 56337, Sept. 17, 2015, as amended at 85 FR 16555, Mar. 24, 2020]



                     Subpart E_Supply-Chain Program



Sec. 507.105  Requirement to establish and implement a supply-chain
program.

    (a)(1) Except as provided by paragraphs (a)(2) and (3) of this 
section, the receiving facility must establish and implement a risk-
based supply-chain program for those raw materials and other ingredients 
for which the receiving facility has identified a hazard requiring a 
supply-chain-applied control.
    (2) A receiving facility that is an importer, is in compliance with 
the foreign supplier verification requirements under part 1, subpart L 
of this chapter, and has documentation of verification activities 
conducted under Sec. 1.506(e) of this chapter (which provides assurance 
that the hazards requiring a supply-chain-applied control for the raw 
material or other ingredient have been significantly minimized or 
prevented) need not conduct supplier verification activities for that 
raw material or other ingredient.
    (3) The requirements in this subpart do not apply to animal food 
that is supplied for research or evaluation use, provided that such 
animal food:
    (i) Is not intended for retail sale and is not sold or distributed 
to the public;
    (ii) Is labeled with the statement ``Animal food for research or 
evaluation use'';
    (iii) Is supplied in a small quantity that is consistent with a 
research, analysis, or quality assurance purpose, the animal food is 
used only for this purpose, and any unused quantity is properly disposed 
of; and
    (iv) Is accompanied with documents, in accordance with the practice 
of the trade, stating that the animal food will be used for research or 
evaluation purposes and cannot be sold or distributed to the public.
    (b) The supply-chain program must be written.
    (c) When a supply-chain-applied control is applied by an entity 
other than the receiving facility's supplier (e.g., when a non-supplier 
applies controls to certain produce (i.e., produce covered by part 112 
of this chapter), because growing, harvesting, and packing activities 
are under different management), the receiving facility must:

[[Page 61]]

    (1) Verify the supply-chain-applied control; or
    (2) Obtain documentation of an appropriate verification activity 
from another entity, review and assess the entity's applicable 
documentation, and document that review and assessment.

    Effective Date Note: At 80 FR 56337, Sept. 17, 2015, part 507 was 
added, effective Nov. 16, 2015, with the exception of paragraph (a)(2) 
in Sec. 507.105, which is not yet effective.



Sec. 507.110  General requirements applicable to a supply-chain
program.

    (a) The supply-chain program must include:
    (1) Using approved suppliers as required by Sec. 507.120;
    (2) Determining appropriate supplier verification activities 
(including determining the frequency of conducting the activity) as 
required by Sec. 507.125;
    (3) Conducting supplier verification activities as required by 
Sec. Sec. 507.130 and 507.135;
    (4) Documenting supplier verification activities as required by 
Sec. 507.175; and
    (5) When applicable, verifying a supply-chain-applied control 
applied by an entity other than the receiving facility's supplier and 
documenting that verification as required by Sec. 507.175, or obtaining 
documentation of an appropriate verification activity from another 
entity, reviewing and assessing that documentation, and documenting the 
review and assessment as required by Sec. 507.175.
    (b) The following are appropriate supplier verification activities 
for raw materials and other ingredients:
    (1) Onsite audits;
    (2) Sampling and testing of the raw material or other ingredient;
    (3) Review of the supplier's relevant food safety records; and
    (4) Other appropriate supplier verification activities based on 
supplier performance and the risk associated with the raw material or 
other ingredient.
    (c) The supply-chain program must provide assurance that a hazard 
requiring a supply-chain-applied control has been significantly 
minimized or prevented.
    (d)(1) Except as provided by paragraph (d)(2) of this section, in 
approving suppliers and determining the appropriate supplier 
verification activities and the frequency with which they are conducted, 
the following must be considered:
    (i) The hazard analysis of the animal food, including the nature of 
the hazard controlled before receipt of the raw material or other 
ingredient, applicable to the raw material and other ingredients;
    (ii) The entity or entities that will be applying controls for the 
hazards requiring a supply-chain-applied control;
    (iii) Supplier performance, including:
    (A) The supplier's procedures, processes, and practices related to 
the safety of the raw material and other ingredients;
    (B) Applicable FDA food safety regulations and information relevant 
to the supplier's compliance with those regulations, including an FDA 
warning letter or import alert relating to the safety of animal food and 
other FDA compliance actions related to animal food safety (or, when 
applicable, relevant laws and regulations of a country whose food safety 
system FDA has officially recognized as comparable or has determined to 
be equivalent to that of the United States, and information relevant to 
the supplier's compliance with those laws and regulations); and
    (C) The supplier's food safety history relevant to the raw materials 
or other ingredients that the receiving facility receives from the 
supplier, including available information about results from testing raw 
materials or other ingredients for hazards, audit results relating to 
the safety of the animal food, and responsiveness of the supplier in 
correcting problems; and
    (iv) Any other factors as appropriate and necessary, such as storage 
and transportation practices.
    (2) Considering supplier performance can be limited to the 
supplier's compliance history as required by paragraph (d)(1)(iii)(B) of 
this section, if the supplier is:
    (i) A qualified facility as defined by Sec. 507.3;
    (ii) A farm that grows produce and is not a covered farm under part 
112 of this chapter in accordance with Sec. 112.4(a), or in accordance 
with Sec. Sec. 112.4(b) and 112.5; or

[[Page 62]]

    (iii) A shell egg producer that is not subject to the requirements 
of part 118 of this chapter because it has less than 3,000 laying hens.
    (e) If the owner, operator, or agent in charge of a receiving 
facility determines through auditing, verification testing, document 
review, relevant consumer, customer, or other complaints, or otherwise 
that the supplier is not controlling hazards that the receiving facility 
has identified as requiring a supply-chain-applied control, the 
receiving facility must take and document prompt action in accordance 
with Sec. 507.42 to ensure that raw materials or other ingredients from 
the supplier do not cause animal food that is manufactured or processed 
by the receiving facility to be adulterated under section 402 of the 
Federal Food, Drug, and Cosmetic Act.



Sec. 507.115  Responsibilities of the receiving facility.

    (a)(1) The receiving facility must approve suppliers.
    (2) Except as provided by paragraphs (a)(3) and (4) of this section, 
the receiving facility must determine and conduct appropriate supplier 
verification activities, and satisfy all documentation requirements of 
this subpart.
    (3) An entity other than the receiving facility may do any of the 
following, provided that the receiving facility reviews and assesses the 
entity's applicable documentation, and documents that review and 
assessment:
    (i) Establish written procedures for receiving raw materials and 
other ingredients by the entity;
    (ii) Document that written procedures for receiving raw materials 
and other ingredients are being followed by the entity; and
    (iii) Determine, conduct, or both determine and conduct, the 
appropriate supplier verification activities, with appropriate 
documentation.
    (4) The supplier may conduct and document sampling and testing of 
raw materials and other ingredients, for the hazard controlled by the 
supplier, as a supplier verification activity for a particular lot of 
product and provide such documentation to the receiving facility, 
provided that the receiving facility reviews and assesses that 
documentation, and documents that review and assessment.
    (b) For the purposes of this subpart, a receiving facility may not 
accept any of the following as a supplier verification activity:
    (1) A determination by its supplier of the appropriate supplier 
verification activities for that supplier;
    (2) An audit conducted by its supplier;
    (3) A review by its supplier of that supplier's own relevant food 
safety records; or
    (4) The conduct by its supplier of other appropriate supplier 
verification activities for that supplier within the meaning of Sec. 
507.110(b)(4).
    (c) The requirements of this section do not prohibit a receiving 
facility from relying on an audit provided by its supplier when the 
audit of the supplier was conducted by a third-party qualified auditor 
in accordance with Sec. Sec. 507.130(f) and 507.135.



Sec. 507.120  Using approved suppliers.

    (a) The receiving facility must approve suppliers in accordance with 
the requirements of Sec. 507.110(d), and document that approval, before 
receiving raw materials and other ingredients received from those 
suppliers;
    (b)(1) Written procedures for receiving raw materials and other 
ingredients must be established and followed;
    (2) The written procedures for receiving raw materials and other 
ingredients must ensure that raw materials and other ingredients are 
received only from approved suppliers (or, when necessary and 
appropriate, on a temporary basis from unapproved suppliers whose raw 
materials or other ingredients are subjected to adequate verification 
activities before acceptance for use); and
    (3) Use of the written procedures for receiving raw materials and 
other ingredients must be documented.



Sec. 507.125  Determining appropriate supplier verification activities
(including determining the frequency of conducting the activity).

    Appropriate supplier verification activities (including the 
frequency of conducting the activity) must be determined in accordance 
with the requirements of Sec. 507.110(d).

[[Page 63]]



Sec. 507.130  Conducting supplier verification activities for raw 
materials and other ingredients.

    (a) Except as provided by paragraphs (c), (d), or (e) of this 
section, one or more of the supplier verification activities specified 
in Sec. 507.110(b), as determined under Sec. 507.110(d), must be 
conducted for each supplier before using the raw material or other 
ingredient from that supplier and periodically thereafter.
    (b)(1) Except as provided by paragraph (b)(2) of this section, when 
a hazard in a raw material or other ingredient will be controlled by the 
supplier and is one for which there is a reasonable probability that 
exposure to the hazard will result in serious adverse health 
consequences or death to humans or animals:
    (i) The appropriate supplier verification activity is an onsite 
audit of the supplier; and
    (ii) The audit must be conducted before using the raw material or 
other ingredient from the supplier and at least annually thereafter.
    (2) The requirements of paragraph (b)(1) of this section do not 
apply if there is a written determination that other verification 
activities and/or less frequent onsite auditing of the supplier provide 
adequate assurance that the hazards are controlled.
    (c) If a supplier is a qualified facility as defined by Sec. 507.3, 
the receiving facility does not need to comply with paragraphs (a) and 
(b) of this section if the receiving facility:
    (1) Obtains written assurance that the supplier is a qualified 
facility as defined by Sec. 507.3:
    (i) Before first approving the supplier for an applicable calendar 
year; and
    (ii) On an annual basis thereafter, by December 31 of each calendar 
year, for the following calendar year; and
    (2) Obtains written assurance, at least every 2 years, that the 
supplier is producing the raw material or other ingredient in compliance 
with applicable FDA food safety regulations (or, when applicable, 
relevant laws and regulations of a country whose food safety system FDA 
has officially recognized as comparable or has determined to be 
equivalent to that of the United States). The written assurance must 
include either:
    (i) A brief description of the preventive controls that the supplier 
is implementing to control the applicable hazard in the animal food; or
    (ii) A statement that the facility is in compliance with State, 
local, county, tribal, or other applicable non-Federal food safety laws, 
including relevant laws and regulations of foreign countries.
    (d) If a supplier is a farm that grows produce and is not a covered 
farm under part 112 of this chapter in accordance with Sec. 112.4(a), 
or in accordance with Sec. Sec. 112.4(b) and 112.5, the receiving 
facility does not need to comply with paragraphs (a) and (b) of this 
section for produce that the receiving facility receives from the farm 
as a raw material or other ingredient if the receiving facility:
    (1) Obtains written assurance that the raw material or other 
ingredient provided by the supplier is not subject to part 112 of this 
chapter in accordance with Sec. 112.4(a), or in accordance with 
Sec. Sec. 112.4(b) and 112.5:
    (i) Before first approving the supplier for an applicable calendar 
year; and
    (ii) On an annual basis thereafter, by December 31 of each calendar 
year, for the following calendar year; and
    (2) Obtains written assurance, at least every 2 years, that the farm 
acknowledges that its food is subject to section 402 of the Federal 
Food, Drug, and Cosmetic Act (or, when applicable, that its food is 
subject to relevant laws and regulations of a country whose food safety 
system FDA has officially recognized as comparable or has determined to 
be equivalent to that of the United States).
    (e) If a supplier is a shell egg producer that is not subject to the 
requirements of part 118 of this chapter because it has less than 3,000 
laying hens, the receiving facility does not need to comply with 
paragraphs (a) and (b) of this section if the receiving facility:
    (1) Obtains written assurance that the shell eggs produced by the 
supplier are not subject to part 118 because the shell egg producer has 
less than 3,000 laying hens:

[[Page 64]]

    (i) Before first approving the supplier for an applicable calendar 
year; and
    (ii) On an annual basis thereafter, by December 31 of each calendar 
year, for the following calendar year; and
    (2) Obtains written assurance, at least every 2 years, that the 
shell egg producer acknowledges that its food is subject to section 402 
of the Federal Food, Drug, and Cosmetic Act (or, when applicable, that 
its food is subject to relevant laws and regulations of a country whose 
food safety system FDA has officially recognized as comparable or has 
determined to be equivalent to that of the United States).
    (f) There must not be any financial conflicts of interest that 
influence the results of the verification activities listed in Sec. 
507.110(b) and payment must not be related to the results of the 
activity.

[80 FR 56337, Sept. 17, 2015, as amended at 84 FR 12491, Apr. 2, 2019]



Sec. 507.135  Onsite audit.

    (a) An onsite audit of a supplier must be performed by a qualified 
auditor.
    (b) If the raw material or other ingredient at the supplier is 
subject to one or more FDA food safety regulations, an onsite audit must 
consider such regulations and include a review of the supplier's written 
plan (e.g., Hazard Analysis and Critical Control Point (HACCP) plan or 
other food safety plan), if any, and its implementation, for the hazard 
being controlled (or, when applicable, an onsite audit may consider 
relevant laws and regulations of a country whose food safety system FDA 
has officially recognized as comparable or has determined to be 
equivalent to that of the United States).
    (c)(1) The following may be substituted for an onsite audit, 
provided that the inspection was conducted within 1 year of the date 
that the onsite audit would have been required to be conducted:
    (i) The written results of an appropriate inspection of the supplier 
for compliance with applicable FDA food safety regulations by FDA, by 
representatives of other Federal Agencies (such as the United States 
Department of Agriculture), or by representatives of State, local, 
tribal, or territorial agencies; or
    (ii) For a foreign supplier, the written results of an inspection by 
FDA or the food safety authority of a country whose food safety system 
FDA has officially recognized as comparable or has determined to be 
equivalent to that of the United States.
    (2) For inspections conducted by the food safety authority of a 
country whose food safety system FDA has officially recognized as 
comparable or determined to be equivalent, the animal food that is the 
subject of the onsite audit must be within the scope of the official 
recognition or equivalence determination, and the foreign supplier must 
be in, and under the regulatory oversight of, such country.
    (d) If the onsite audit is solely conducted to meet the requirements 
of this subpart by an audit agent of a certification body that is 
accredited in accordance with regulations in part 1, subpart M of this 
chapter, the audit is not subject to the requirements in those 
regulations.

    Effective Date Note: At 80 FR 56337, Sept. 17, 2015, part 507 was 
added, effective Nov. 16, 2015, with the exception of paragraph (d) in 
Sec. 507.135, which is not yet effective.



Sec. 507.175  Records documenting the supply-chain program.

    (a) The records documenting the supply-chain program are subject to 
the requirements of subpart F of this part.
    (b) The receiving facility must review the records listed in 
paragraph (c) of this section in accordance with Sec. 507.49(a)(4).
    (c) The receiving facility must document the following in records as 
applicable to its supply-chain program:
    (1) The written supply-chain program;
    (2) Documentation that a receiving facility that is an importer is 
in compliance with the foreign supplier verification program 
requirements under part 1, subpart L of this chapter, including 
documentation of verification activities conducted under Sec. 1.506(e) 
of this chapter;
    (3) Documentation of the approval of a supplier;
    (4) Written procedures for receiving raw materials and other 
ingredients;

[[Page 65]]

    (5) Documentation demonstrating use of the written procedures for 
receiving raw materials and other ingredients;
    (6) Documentation of the determination of the appropriate supplier 
verification activities for raw materials and other ingredients;
    (7) Documentation of the conduct of an onsite audit. This 
documentation must include:
    (i) The name of the supplier subject to the onsite audit;
    (ii) Documentation of audit procedures;
    (iii) The dates the audit was conducted;
    (iv) The conclusions of the audit;
    (v) Corrective actions taken in response to significant deficiencies 
identified during the audit; and
    (vi) Documentation that the audit was conducted by a qualified 
auditor;
    (8) Documentation of sampling and testing conducted as a supplier 
verification activity. This documentation must include:
    (i) Identification of the raw material or other ingredient tested 
(including lot number, as appropriate) and the number of samples tested;
    (ii) Identification of the test(s) conducted, including the 
analytical method(s) used;
    (iii) The date(s) on which the test(s) were conducted and the date 
of the report;
    (iv) The results of the testing;
    (v) Corrective actions taken in response to detection of hazards; 
and
    (vi) Information identifying the laboratory conducting the testing;
    (9) Documentation of the review of the supplier's relevant food 
safety records. This documentation must include:
    (i) The name of the supplier whose records were reviewed;
    (ii) The date(s) of review;
    (iii) The general nature of the records reviewed;
    (iv) The conclusions of the review; and
    (v) Corrective actions taken in response to significant deficiencies 
identified during the review;
    (10) Documentation of other appropriate supplier verification 
activities based on the supplier performance and the risk associated 
with the raw material or other ingredient;
    (11) Documentation of any determination that verification activities 
other than an onsite audit, and/or less frequent onsite auditing of a 
supplier, provide adequate assurance that the hazards are controlled 
when a hazard in a raw material or other ingredient will be controlled 
by the supplier and is one for which there is a reasonable probability 
that exposure to the hazard will result in serious adverse health 
consequences or death to humans or animals;
    (12) The following documentation of an alternative verification 
activity for a supplier that is a qualified facility:
    (i) The written assurance that the supplier is a qualified facility 
as defined by Sec. 507.3; and
    (ii) The written assurance that the supplier is producing the raw 
material or other ingredient in compliance with applicable FDA food 
safety regulations (or, when applicable, relevant laws and regulations 
of a country whose food safety system FDA has officially recognized as 
comparable or has determined to be equivalent to that of the United 
States);
    (13) The following documentation of an alternative verification 
activity for a supplier that is a farm that supplies a raw material or 
other ingredient and is not a covered farm under part 112 of this 
chapter:
    (i) The written assurance that supplier is not a covered farm under 
part 112 of this chapter in accordance with Sec. 112.4(a), or in 
accordance with Sec. Sec. 112.4(b) and 112.5; and
    (ii) The written assurance that the farm acknowledges that its food 
is subject to section 402 of the Federal Food, Drug, and Cosmetic Act 
(or, when applicable, that its food is subject to relevant laws and 
regulations of a country whose food safety system FDA has officially 
recognized as comparable or has determined to be equivalent to that of 
the United States);
    (14) The following documentation of an alternative verification 
activity for a supplier that is a shell egg producer that is not subject 
to the requirements established in part 118 of this chapter because it 
has less than 3,000 laying hens:

[[Page 66]]

    (i) The written assurance that the shell eggs provided by the 
supplier are not subject to part 118 of this chapter because the 
supplier has less than 3,000 laying hens; and
    (ii) The written assurance that the shell egg producer acknowledges 
that its food is subject to section 402 of the Federal Food, Drug, and 
Cosmetic Act (or, when applicable, that its food is subject to relevant 
laws and regulations of a country whose safety system FDA has officially 
recognized as comparable or has determined to be equivalent to that of 
the United States);
    (15) The written results of an appropriate inspection of the 
supplier for compliance with applicable FDA food safety regulations by 
FDA, by representatives of other Federal Agencies (such as the United 
States Department of Agriculture), or by representatives from State, 
local, tribal, or territorial agencies, or the food safety authority of 
another country when the results of such an inspection is substituted 
for an onsite audit;
    (16) Documentation of actions taken with respect to supplier non-
conformance;
    (17) Documentation of verification of a supply-chain-applied control 
applied by an entity other than the receiving facility's supplier; and
    (18) When applicable, documentation of the receiving facility's 
review and assessment of:
    (i) Applicable documentation from an entity other than the receiving 
facility that written procedures for receiving raw materials and other 
ingredients are being followed;
    (ii) Applicable documentation, from an entity other than the 
receiving facility, of the determination of the appropriate supplier 
verification activities for raw materials and other ingredients;
    (iii) Applicable documentation, from an entity other than the 
receiving facility, of conducting the appropriate supplier verification 
activities for raw materials and other ingredients;
    (iv) Applicable documentation, from its supplier, of:
    (A) The results of sampling and testing conducted by the supplier; 
or
    (B) The results of an audit conducted by a third-party qualified 
auditor in accordance with Sec. Sec. 507.130(f) and 507.135; and
    (v) Applicable documentation, from an entity other than the 
receiving facility, of verification activities when a supply-chain-
applied control is applied by an entity other than the receiving 
facility's supplier.

    Effective Date Note: At 80 FR 56337, Sept. 17, 2015, part 507 was 
added, effective Nov. 16, 2015, with the exception of paragraph (c)(2) 
in Sec. 507.175, which is not yet effective.



Subpart F_Requirements Applying to Records That Must Be Established and 
                               Maintained



Sec. 507.200  Records subject to the requirements of this subpart.

    (a) Except as provided by paragraphs (d) and (e) of this section, 
all records required by this part are subject to all requirements of 
this subpart.
    (b) Records obtained by FDA in accordance with this part are subject 
to the disclosure requirements under part 20 of this chapter.
    (c) All records required by this part must be made promptly 
available to a duly authorized representative of the Secretary of Health 
and Human Services for official review and copying upon oral or written 
request.
    (d) The requirements of Sec. 507.206 apply only to the written food 
safety plan.
    (e) The requirements of Sec. 507.202(a)(2), (4), and (5) and (b) do 
not apply to the records required by Sec. 507.7.



Sec. 507.202  General requirements applying to records.

    (a) Records must:
    (1) Be kept as original records, true copies (such as photocopies, 
pictures, scanned copies, microfilm, microfiche, or other accurate 
reproductions of the original records), or electronic records;
    (2) Contain the actual values and observations obtained during 
monitoring and as appropriate, during verification activities;
    (3) Be accurate, indelible, and legible;
    (4) Be created concurrently with performance of the activity 
documented; and
    (5) Be as detailed as necessary to provide history of work 
performed.
    (b) All records must include:

[[Page 67]]

    (1) Information adequate to identify the plant or facility (e.g., 
the name, and when necessary, the location of the plant or facility);
    (2) The date and, when appropriate, the time of the activity 
documented;
    (3) The signature or initials of the person performing the activity; 
and
    (4) Where appropriate, the identity of the product and the lot code, 
if any.
    (c) Records that are established or maintained to satisfy the 
requirements of this part and that meet the definition of electronic 
records in Sec. 11.3(b)(6) of this chapter are exempt from the 
requirements of part 11 of this chapter. Records that satisfy the 
requirements of this part, but that also are required under other 
applicable statutory provisions or regulations, remain subject to part 
11 of this chapter.



Sec. 507.206  Additional requirements applying to the food safety plan.

    The owner, operator, or agent in charge of the facility must sign 
and date the food safety plan upon initial completion and upon any 
modification.



Sec. 507.208  Requirements for record retention.

    (a)(1) All records required by this part must be retained at the 
plant or facility for at least 2 years after the date they were 
prepared.
    (2) Records that a facility relies on during the 3-year period 
preceding the applicable calendar year to support its status as a 
qualified facility must be retained at the facility as long as necessary 
to support the status of a facility as a qualified facility during the 
applicable calendar year.
    (b) Records that relate to the general adequacy of the equipment or 
processes being used by a facility, including the results of scientific 
studies and evaluations, must be retained by the facility for at least 2 
years after their use is discontinued (e.g., because the facility has 
updated the written food safety plan (Sec. 507.31) or records that 
document validation of the written food safety plan (Sec. 507.45(b))).
    (c) Except for the food safety plan, offsite storage of records is 
permitted if such records can be retrieved and provided onsite within 24 
hours of request for official review. The food safety plan must remain 
onsite. Electronic records are considered to be onsite if they are 
accessible from an onsite location.
    (d) If the plant or facility is closed for a prolonged period, the 
food safety plan may be transferred to some other reasonably accessible 
location but must be returned to the plant or facility within 24 hours 
for official review upon request.



Sec. 507.212  Use of existing records.

    (a) Existing records (e.g., records that are kept to comply with 
other Federal, State, or local regulations, or for any other reason) do 
not need to be duplicated if they contain all of the required 
information and satisfy the requirements of this subpart. Existing 
records may be supplemented as necessary to include all of the required 
information and satisfy the requirements of this subpart.
    (b) The information required by this part does not need to be kept 
in one set of records. If existing records contain some of the required 
information, any new information required by this part may be kept 
either separately or combined with the existing records.



Sec. 507.215  Special requirements applicable to a written assurance.

    (a) Any written assurance required by this part must contain the 
following elements:
    (1) Effective date;
    (2) Printed names and signatures of authorized officials;
    (3) The applicable assurance under:
    (i) Sec. 507.36(a)(2);
    (ii) Sec. 507.36(a)(3);
    (iii) Sec. 507.36(a)(4);
    (iv) Sec. 507.130(c)(2);
    (v) Sec. 507.130(d)(2); or
    (vi) Sec. 507.130(e)(2).
    (b) A written assurance required under Sec. 507.36(a)(2), (3) or 
(4) must include:
    (1) Acknowledgement that the facility that provides the written 
assurance assumes legal responsibility to act consistently with the 
assurance and document its actions taken to satisfy the written 
assurance; and
    (2) Provision that if the assurance is terminated in writing by 
either entity, responsibility for compliance with the

[[Page 68]]

applicable provisions of this part reverts to the manufacturer/processor 
as of the date of termination.



PART 509_UNAVOIDABLE CONTAMINANTS IN ANIMAL FOOD AND FOOD-PACKAGING 
MATERIAL--Table of Contents



                      Subpart A_General Provisions

Sec.
509.3 Definitions and interpretations.
509.4 Establishment of tolerances, regulatory limits, and action levels.
509.5 Petitions.
509.6 Added poisonous or deleterious substances.
509.7 Unavoidability.
509.15 Use of polychlorinated biphenyls (PCB's) in establishments 
          manufacturing food-packaging materials.

Subpart B_Tolerances for Unavoidable Poisonous or Deleterious Substances

509.30 Temporary tolerances for polychlorinated biphenyls (PCB's).

Subpart C--Regulatory Limits for Added Poisonous or Deleterious Substances 
[Reserved]

Subpart D--Naturally Occurring Poisonous or Deleterious Substances 
[Reserved]

    Authority: 21 U.S.C. 336, 342, 346, 346a, 348, 371.

    Source: 42 FR 52821, Sept. 30, 1977, unless otherwise noted.



                      Subpart A_General Provisions



Sec. 509.3  Definitions and interpretations.

    (a) Act means the Federal Food, Drug, and Cosmetic Act.
    (b) The definitions of terms contained in section 201 of the act are 
applicable to such terms when used in this part unless modified in this 
section.
    (c) A naturally occurring poisonous or deleterious substance is a 
poisonous or deleterious substance that is an inherent natural 
constituent of a food and is not the result of environmental, 
agricultural, industrial, or other contamination.
    (d) An added poisonous or deleterious substance is a poisonous or 
deleterious substance that is not a naturally occurring poisonous or 
deleterious substance. When a naturally occurring poisonous or 
deleterious substance is increased to abnormal levels through 
mishandling or other intervening acts, it is an added poisonous or 
deleterious substance to the extent of such increase.
    (e) Food includes pet food, animal feed, and substances migrating to 
food from food-contact articles.



Sec. 509.4  Establishment of tolerances, regulatory limits, and action levels.

    (a) When appropriate under the criteria of Sec. 509.6, a tolerance 
for an added poisonous or deleterious substance, which may be a food 
additive, may be established by regulation in subpart B of this part 
under the provisions of section 406 of the act. A tolerance may prohibit 
any detectable amount of the substance in food.
    (b) When appropriate under the criteria of Sec. 509.6, and under 
section 402(a)(1) of the act, a regulatory limit for an added poisonous 
or deleterious substance, which may be a food additive, may be 
established by regulation in subpart C of this part under the provisions 
of sections 402(a)(1) and 701(a) of the act. A regulatory limit may 
prohibit any detectable amount of the substance in food. The regulatory 
limit established represents the level at which food is adulterated 
within the meaning of section 402(a)(1) of the act.
    (c)(1) When appropriate under the criteria of Sec. 509.6, an action 
level for an added poisonous or deleterious substance, which may be a 
food additive, may be established to define a level of contamination at 
which a food may be regarded as adulterated.
    (2) Whenever an action level is established or changed, a notice 
shall be published in the Federal Register as soon as practicable 
thereafter. The notice shall call attention to the material supporting 
the action level which shall be on file with the Division of Dockets 
Management before the notice is published. The notice shall invite 
public comment on the action level.
    (d) A regulation may be established in subpart D of this part to 
identify a food containing a naturally occurring poisonous or 
deleterious substance which will be deemed to be adulterated

[[Page 69]]

under section 402(a)(1) of the act. These regulations do not constitute 
a complete list of such foods.

[42 FR 52821, Sept. 30, 1977, as amended at 55 FR 20786, May 21, 1990]



Sec. 509.5  Petitions.

    The Commissioner of Food and Drugs, either on his own initiative or 
on behalf of any interested person who has submitted a petition, may 
issue a proposal to establish, revoke, or amend a regulation under this 
part. Any such petition shall include an adequate factual basis to 
support the petition, shall be in the form set forth in Sec. 10.30 of 
this chapter, and will be published in the Federal Register for comment 
if it contains reasonable grounds for the proposed regulation.

[42 FR 52821, Sept. 30, 1977, as amended at 54 FR 18280, Apr. 28, 1989]



Sec. 509.6  Added poisonous or deleterious substances.

    (a) Use of an added poisonous or deleterious substance, other than a 
pesticide chemical, that is also a food additive will be controlled by a 
regulation issued under section 409 of the act when possible. When such 
a use cannot be approved under the criteria of section 409 of the act, 
or when the added poisonous or deleterious substance is not a food 
additive, a tolerance, regulatory limit, or action level may be 
established pursuant to the criteria in paragraphs (b), (c), or (d) of 
this section. Residues resulting from the use of an added poisonous or 
deleterious substance that is also a pesticide chemical will ordinarily 
be controlled by a tolerance established in a regulation issued under 
sections 406, 408, or 409 of the act by the U.S. Environmental 
Protection Agency (EPA). When such a regulation has not been issued, an 
action level for an added poisonous or deleterious substance that is 
also a pesticide chemical may be established by the Food and Drug 
Administration. The Food and Drug Administration will request EPA to 
recommend such an action level pursuant to the criteria established in 
paragraph (d) of this section.
    (b) A tolerance for an added poisonous or deleterious substance in 
any food may be established when the following criteria are met:
    (1) The substance cannot be avoided by good manufacturing practice.
    (2) The tolerance established is sufficient for the protection of 
the public health, taking into account the extent of which the presence 
of the substance cannot be avoided and the other ways in which the 
consumer may be affected by the same or related poisonous or deleterious 
substances.
    (3) No technological or other changes are foreseeable in the near 
future that might affect the appropriateness of the tolerance 
established. Examples of changes that might affect the appropriateness 
of the tolerance include anticipated improvements in good manufacturing 
practice that would change the extent to which use of the substance is 
unavoidable and anticipated studies expected to provide significant new 
toxicological or use data.
    (c) A regulatory limit for an added poisonous or deleterious 
substance in any food may be established when each of the following 
criteria is met:
    (1) The substance cannot be avoided by current good manufacturing 
practices.
    (2) There is no tolerance established for the substance in the 
particular food under sections 406, 408, or 409 of the act.
    (3) There is insufficient information by which a tolerance may be 
established for the substance under section 406 of the act or 
technological changes appear reasonably possible that may affect the 
appropriateness of a tolerance. The regulatory limit established 
represents the level at which food is adulterated within the meaning of 
section 402(a)(1) of the act.
    (d) An action level for an added poisonous or deleterious substance 
in any food may be established when the criteria in paragraph (b) of 
this section are met, except that technological or other changes that 
might affect the appropriateness of the tolerance are foreseeable in the 
near future. An action level for an added poisonous or deleterious 
substance in any food may be established at a level at which the Food 
and Drug Administration may regard the food as adulterated within the 
meaning of section 402(a)(1) of the act,

[[Page 70]]

without regard to the criteria in paragraph (b) of this section or in 
section 406 of the act. An action level will be withdrawn when a 
tolerance or regulatory limit for the same substance and use has been 
established.
    (e) Tolerances will be established under authority appropriate for 
action levels (sections 306, 402(a), and 701(a) of the act, together 
with section 408 or 409 of the act, if appropriate) as well as under 
authority appropriate for tolerances (sections 406 and 701 of the act). 
In the event the effectiveness of a tolerance is stayed pursuant to 
section 701(e)(2) of the act by the filing of an objection, the order 
establishing the tolerance shall be deemed to be an order establishing 
an action level until final action is taken upon such objection.

[42 FR 52821, Sept. 30, 1977, as amended at 55 FR 20786, May 21, 1990]



Sec. 509.7  Unavoidability.

    (a) Tolerances and action levels in this part are established at 
levels based on the unavoidability of the poisonous or deleterious 
substance concerned and do not establish a permissible level of 
contamination where it is avoidable.
    (b) Compliance with tolerances, regulatory limits, and action levels 
does not excuse failure to observe either the requirement in section 
402(a)(4) of the act that food may not be prepared, packed, or held 
under insanitary conditions or the other requirements in this chapter 
that food manufacturers must observe current good manufacturing 
practices. Evidence obtained through factory inspection or otherwise 
indicating such a violation renders the food unlawful, even though the 
amounts of poisonous or deleterious substances are lower than the 
currently established tolerances, regulatory limits, or action levels. 
The manufacturer of food must at all times utilize quality control 
procedures which will reduce contamination to the lowest level currently 
feasible.

[42 FR 52821, Sept. 30, 1977, as amended at 55 FR 20786, May 21, 1990]



Sec. 509.15  Use of polychlorinated biphenyls (PCB's) in 
establishments manufacturing food-packaging materials.

    (a) Polychlorinated biphenyls (PCB's) represent a class of toxic 
industrial chemicals manufactured and sold under a variety of trade 
names, including: Aroclor (United States); Phenoclor (France); Colphen 
(Germany); and Kanaclor (Japan). PCB's are highly stable, heat 
resistant, and nonflammable chemicals. Industrial uses of PCB's include, 
or did include in the past, their use as electrical transformer and 
capacitor fluids, heat transfer fluids, hydraulic fluids, and 
plasticizers, and in formulations of lubricants, coatings, and inks. 
Their unique physical and chemical properties and widespread, 
uncontrolled industrial applications have caused PCB's to be a 
persistent and ubiquitous contaminant in the environment, causing the 
contamination of certain foods. In addition, incidents have occurred in 
which PCB's have directly contaminated animal feeds as a result of 
industrial accidents (leakage or spillage of PCB fluids from plant 
equipment). These accidents in turn caused the contamination of food 
products intended for human consumption (meat, milk and eggs). 
Investigations by the Food and Drug Administration have revealed that a 
significant percentage of paper food-packaging material contains PCB's 
which can migrate to the packaged food. The origin of PCB's in such 
material is not fully understood. Reclaimed fibers containing carbonless 
copy paper (contains 3 to 5 percent PCB's) have been identified as a 
primary source of PCB's in paper products. Some virgin paper products 
have also been found to contain PCB's, the source of which is generally 
attributed to direct contamination from industrial accidents from the 
use of PCB-containing equipment and machinery in food-packaging 
manufacturing establishments. Since PCB's are toxic chemicals, the PCB 
contamination of food-packaging materials as a result of industrial 
accidents, which can cause the PCB contamination of food, represents a 
hazard to public health. It is therefore necessary to place certain 
restrictions on the industrial uses of

[[Page 71]]

PCB's in establishments manufacturing food-packaging materials.
    (b) The following special provisions are necessary to preclude the 
accidental PCB contamination of food-packaging materials:
    (1) New equipment or machinery for manufacturing food-packaging 
materials shall not contain or use PCB's.
    (2) On or before September 4, 1973, the management of establishments 
manufacturing food-packaging materials shall:
    (i) Have the heat exchange fluid used in existing equipment for 
manufacturing food-packaging materials sampled and tested to determine 
whether it contains PCB's or verify the absence of PCB's in such 
formulations by other appropriate means. On or before Sept. 4, 1973, any 
such fluid formulated with PCB's must to the fullest extent possible 
commensurate with current good manufacturing practices be replaced with 
a heat exchange fluid that does not contain PCB's.
    (ii) Eliminate to the fullest extent possible commensurate with 
current good manufacturing practices from the establishment any other 
PCB-containing equipment, machinery and materials wherever there is a 
reasonable expectation that such articles could cause food-packaging 
materials to become contaminated with PCB's either as a result of normal 
use or as a result of accident, breakage, or other mishap.
    (iii) The toxicity and other characteristics of fluids selected as 
PCB replacements must be adequately determined so that the least 
potentially hazardous replacement is used. In making this determination 
with respect to a given fluid, consideration should be given to (a) its 
toxicity; (b) the maximum quantity that could be spilled onto a given 
quantity of food before it would be noticed, taking into account its 
color and odor; (c) possible signaling devices in the equipment to 
indicate a loss of fluid, etc.; and (d) its environmental stability and 
tendency to survive and be concentrated through the food chain. The 
judgment as to whether a replacement fluid is sufficiently non-hazardous 
is to be made on an individual installation and operation basis.
    (c) The provisions of this section do not apply to electrical 
transformers and condensers containing PCB's in sealed containers.



Subpart B_Tolerances for Unavoidable Poisonous or Deleterious Substances



Sec. 509.30  Temporary tolerances for polychlorinated biphenyls
(PCB's).

    (a) Polychlorinated biphenyls (PCB's) are toxic, industrial 
chemicals. Because of their widespread, uncontrolled industrial 
applications, PCB's have become a persistent and ubiquitous contaminant 
in the environment. As a result, certain foods and animal feeds, 
principally those of animal and marine origin, contain PCB's as 
unavoidable, environmental contaminants. PCB's are transmitted to the 
food portion (meat, milk, and eggs) of food producing animals ingesting 
PCB contaminated animal feed. In addition, a significant percentage of 
paper food-packaging materials contain PCB's which may migrate to the 
packaged food. The source of PCB's in paper food-packaging materials is 
primarily of certain types of carbonless copy paper (containing 3 to 5 
percent PCB's) in waste paper stocks used for manufacturing recycled 
paper. Therefore, temporary tolerances for residues of PCB's as 
unavoidable environmental or industrial contaminants are established for 
a sufficient period of time following the effective date of this 
paragraph to permit the elimination of such contaminants at the earliest 
practicable time. For the purposes of this paragraph, the term 
polychlorinated biphenyls (PCB's) is applicable to mixtures of 
chlorinated biphenyl compounds, irrespective of which mixture of PCB's 
is present as the residue. The temporary tolerances for residues of 
PCB's are as follows:
    (1) 0.2 part per million in finished animal feed for food-producing 
animals (except the following finished animal feeds: feed concentrates, 
feed supplements, and feed premixes).
    (2) 2 parts per million in animal feed components of animal origin, 
including fishmeal and other by-products of marine origin and in 
finished animal feed concentrates, supplements, and premixes intended 
for food-producing animals.

[[Page 72]]

    (3) 10 parts per million in paper food-packaging material intended 
for or used with finished animal feed and any components intended for 
animal feeds. The tolerance shall not apply to paper food-packaging 
material separated from the food therein by a functional barrier which 
is impermeable to migration of PCB's.
    (b) A compilation entitled ``Analytical Methodology for 
Polychlorinated Biphenyls, February 1973'' for determining compliance 
with the tolerances established in this section is available from the 
Division of Dockets Management, Food and Drug Administration, 5630 
Fishers Lane, rm. 1061, Rockville, MD 20852.

[42 FR 52821, Sept. 30, 1977, as amended at 46 FR 8460, Jan. 27, 1981; 
59 FR 14365, Mar. 28, 1994; 68 FR 24879, May 9, 2003]

Subpart C--Regulatory Limits for Added Poisonous or Deleterious Substances 
[Reserved]

Subpart D--Naturally Occurring Poisonous or Deleterious Substances 
[Reserved]



PART 510_NEW ANIMAL DRUGS--Table of Contents



                      Subpart A_General Provisions

Sec.
510.3 Definitions and interpretations.
510.4 Biologics; products subject to license control.
510.7 Consignees of new animal drugs for use in the manufacture of 
          animal feed.
510.95 [Reserved]

         Subpart B_Specific Administrative Rulings and Decisions

510.105 Labeling of drugs for use in milk-producing animals.
510.106 Labeling of antibiotic and antibiotic-containing drugs intended 
          for use in milk-producing animals.
510.110 Antibiotics used in food-producing animals.
510.112 Antibiotics used in veterinary medicine and for nonmedical 
          purposes; required data.

Subpart C [Reserved]

                      Subpart D_Records and Reports

510.301 Records and reports concerning experience with animal feeds 
          bearing or containing new animal drugs for which an approved 
          medicated feed mill license application is in effect.
510.305 Maintenance of copies of approved medicated feed mill licenses 
          to manufacture animal feed bearing or containing new animal 
          drugs.

          Subpart E_Requirements for Specific New Animal Drugs

510.410 Corticosteroids for oral, injectable, and ophthalmic use in 
          animals; warnings and labeling requirements.
510.440 Injectable iron preparations.
510.455 Requirements for free-choice medicated feeds.

Subpart F [Reserved]

               Subpart G_Sponsors of Approved Applications

510.600 Names, addresses, and drug labeler codes of sponsors of approved 
          applications.

    Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.

    Source: 40 FR 13807, Mar. 27, 1975, unless otherwise noted.



                      Subpart A_General Provisions



Sec. 510.3  Definitions and interpretations.

    As used in this part:
    (a) The term act means the Federal Food, Drug, and Cosmetic Act, as 
amended (secs. 201-902, 52 Stat. 1040 et seq., as amended; 21 U.S.C. 
321-392).
    (b) Department means the Department of Health and Human Services.
    (c) Secretary means the Secretary of Health and Human Services.
    (d) Commissioner means the Commissioner of Food and Drugs.
    (e) Person means individuals, partnerships, corporations, and 
associations.
    (f) The definitions and interpretations of terms contained in 
section 201 of the act shall be applicable to such terms when used in 
the regulations in this part.
    (g) The term new animal drug means any drug intended for use for 
animals other than man, including any drug intended for use in animal 
feed but not including such animal feed:
    (1) The composition of which is such that such drug is not generally 
recognized, among experts qualified by scientific training and 
experience to evaluate the safety and effectiveness of

[[Page 73]]

animal drugs, as safe and effective for use under the conditions 
prescribed, recommended, or suggested in the labeling thereof; except 
that such a drug not so recognized shall not be deemed to be a new 
animal drug if at any time prior to June 25, 1938, it was subject to the 
Food and Drug Act of June 30, 1906, as amended, and if at such time its 
labeling contained the same representations concerning the conditions of 
its use; or
    (2) The composition of which is such that such drug, as a result of 
investigations to determine its safety and effectiveness for use under 
such conditions, has become so recognized but which has not, otherwise 
than in such investigations, been used to a material extent or for a 
material time under such conditions.
    (h) The term animal feed means an article which is intended for use 
for food for animals other than man and which is intended for use as a 
substantial source of nutrients in the diet of the animal, and is not 
limited to a mixture intended to be the sole ration of the animal.
    (i) The newness of an animal drug, including a new animal drug 
intended for use in or on animal feed, may arise by reason of: (1) The 
newness for its intended drug use of any substance of which the drug is 
comprised, in whole or in part, whether it be an active substance or a 
menstruum, excipient, carrier, coating, or other component; (2) the 
newness for its intended drug use of a combination of two or more 
substances, none of which is itself a new animal drug; (3) the newness 
for its intended drug use of the proportion of a substance in a 
combination, even though such combination containing such substance in 
other proportion is not a new animal drug; (4) the newness for its 
intended drug use in a different species of animal; (5) the newness of 
its intended drug use in diagnosing, curing, mitigating, treating, or 
preventing a disease, or to affect a structure or function of the animal 
body, even though such drug is not a new animal drug when used in 
another disease or to affect another structure or function of the body; 
or (6) the newness of a dosage, or method or duration of administration 
or application, or any other condition of use prescribed, recommended, 
or suggested in the labeling of such drug, even though such drug or 
animal feed containing such drug when used in another dosage, or another 
method or duration of administration or application, or different 
condition, is not a new animal drug.
    (j) Animals used only for laboratory research and laboratory 
research animals mean individual animals or groups of animals intended 
for use and used solely for laboratory research purposes, regardless of 
species, and does not include animals intended to be used for any food 
purposes or animals intended to be kept as livestock.
    (k) Sponsor means the person requesting designation for a minor-use 
or minor-species drug as defined in part 516 of this chapter, who must 
be the real party in interest of the development and the intended or 
actual production and sales of such drug (in this context, the sponsor 
may be an individual, partnership, organization, or association). 
Sponsor also means the person responsible for an investigation of a new 
animal drug. In this context, the sponsor may be an individual, 
partnership, corporation, or Government agency or may be a manufacturer, 
scientific institution, or an investigator regularly and lawfully 
engaged in the investigation of new animal drugs. Sponsor also means the 
person submitting or receiving approval for a new animal drug 
application (in this context, the sponsor may be an individual, 
partnership, organization, or association). In all contexts, the sponsor 
is responsible for compliance with applicable provisions of the act and 
regulations.

[40 FR 13807, Mar. 27, 1975, as amended at 50 FR 7517, Feb. 22, 1985; 54 
FR 22741, May 26, 1989; 64 FR 69190, Dec. 10, 1999; 72 FR 41017, July 
26, 2007]



Sec. 510.4  Biologics; products subject to license control.

    An animal drug produced and distributed in full conformance with the 
animal virus, serum, and toxin law of March 4, 1913 (37 Stat. 832; 21 
U.S.C. 151 et seq. ) and any regulations issued thereunder shall not be 
deemed to be subject to section 512 of the Federal Food, Drug, and 
Cosmetic Act.

[[Page 74]]



Sec. 510.7  Consignees of new animal drugs for use in the manufacture 
of animal feed.

    (a) A new animal drug intended for use in the manufacture of animal 
feed shall be deemed to be unsafe unless at the time of its removal from 
the establishment of a manufacturer, packer, or distributor of such 
drug, such manufacturer, packer, or distributor has an unrevoked written 
statement from the consignee of such drug, or a notice from the 
Secretary, to the effect that with respect to the use of such drug in 
animal feed the consignee:
    (1) Holds a license issued under Sec. 515.20 of this chapter; or
    (2) Will, if the consignee is not the user of the drug, ship such 
drug only to a holder of an approved application under Sec. 515.10 of 
this chapter.
    (b) The requirements of paragraph (a) of this section do not apply:
    (1) Where such drugs are intended for export and/or
    (2) When the use of such drug in the manufacture of a finished feed 
has been exempted from the requirements of section 512(m) of the act 
under the conditions specified by regulations published in part 558 of 
this chapter.

[40 FR 13807, Mar. 27, 1975, as amended at 64 FR 63203, Nov. 19, 1999]



Sec. 510.95  [Reserved]



         Subpart B_Specific Administrative Rulings and Decisions



Sec. 510.105  Labeling of drugs for use in milk-producing animals.

    (a) Part 526 of this chapter provides for new animal drugs intended 
for intramammary use in animals and includes conditions of use intended 
to prevent the contamination of milk from the use of such drugs.
    (b) Preparations containing antibiotics and other potent drugs 
labeled with directions for use in milk-producing animals will be 
misbranded under section 502(f)(2) of the act unless their labeling 
bears appropriate warnings and directions for use to avoid adulteration 
of milk under section 402(a)(2)(c)(ii) of the act.
    (c) It is the position of the Food and Drug Administration that the 
labeling for such preparations should bear a clear warning that either:
    (1) The article should not be administered to animals producing 
milk, since to do so would result in contamination of the milk; or
    (2) The label should bear the following statement: ``Warning: Milk 
that has been taken from animals during treatment and for __ hours after 
the latest treatment must not be used for food'', the blank being filled 
in with the figure that the manufacturer has determined by appropriate 
investigation is needed to insure that the milk will not carry violative 
residues resulting from use of the preparation. If the use of the 
preparation as recommended does not result in contamination of the milk, 
neither of the above warning statements is required.

[40 FR 13807, Mar. 27, 1975, as amended at 63 FR 32980, June 17, 1998; 
64 FR 51241, Sept. 22, 1999]



Sec. 510.106  Labeling of antibiotic and antibiotic-containing drugs
intended for use in milk-producing animals.

    Whenever the labeling of an antibiotic drug included in the 
regulations in this chapter suggests or recommends its use in milk-
producing animals, the label of such drugs shall bear either the 
statement ``Warning: Not for use in animals producing milk, since this 
use will result in contamination of the milk'' or the statement 
``Warning: Milk that has been taken from animals during treatment and 
for __hours after the latest treatment must not be used for food'', the 
blank being filled in with the figure that the Commissioner has 
authorized the manufacturer of the drug to use. The Commissioner shall 
determine what such figures shall be from information submitted by the 
manufacturer and which the Commissioner considers is adequate to prove 
that period of time after the latest treatment that the milk from 
treated animals will contain no violative residues from use of the 
preparation. If the Commissioner determines from the information 
submitted that the use of the antibiotic drug as recommended does not 
result in its appearance in the milk, the Commissioner may exempt

[[Page 75]]

the drug from bearing either of the above warning statements.

[63 FR 32980, June 17, 1998]



Sec. 510.110  Antibiotics used in food-producing animals.

    (a) The Food and Drug Administration in the interest of fulfilling 
its responsibilities with regard to protection of the public health has 
requested an evaluation of the public health aspects of the use of 
antibiotics in veterinary medical and nonmedical uses. There is 
particular concern with regard to the potential hazards associated with 
the extensive use of antibiotics administered to food-producing animals. 
Accordingly, an ad hoc committee on the Veterinary Medical and 
Nonmedical Uses of Antibiotics was established by the Food and Drug 
Administration to study and advise the Commissioner of Food and Drugs on 
the uses of antibiotics in veterinary medicine and for various 
nonmedical purposes as such uses may affect the enforcement of the 
Federal Food, Drug, and Cosmetic Act with respect to their safety and 
effectiveness.
    (b) Based upon an evaluation of the conclusions of said Committee 
and other relevant material, Sec. 510.112 was published in the Federal 
Register of August 23, 1966 (31 FR 11141), asking sponsors of drugs 
containing any antibiotic intended for use in food-producing animals to 
submit data to establish whether such antibiotic and its metabolites are 
present as residues in edible tissues, milk, and eggs from treated 
animals. The data on the residues of antibiotics in milk from 
intramammary infusion preparations were requested within 60 days and the 
data on all other products were requested within 180 days following the 
date of publication of Sec. 510.112 in the Federal Register.
    (c) An evaluation of the data now available shows that use of many 
antibiotic preparations cause residues in edible products of treated 
animals for varying and, in some cases, for long periods of time 
following the last administration. Because of the accumulation of new 
information with regard to the development of resistance of bacteria to 
antibiotics, the ability of bacteria to transfer this resistance, and 
the development of sensitivity to antibiotics in humans, unauthorized 
and unsafe residues of antibiotics cannot be permitted in food obtained 
from treated animals.
    (d) Based on evaluation of information available, including the 
conclusions of the aforementioned ad hoc Committee, the Commissioner 
concludes that antibiotic preparations intended for use in food-
producing animals, other than topical and ophthalmic preparations, are 
not generally recognized among qualified experts as having been shown to 
be safe for their intended use(s) within the meaning of section 201(s) 
of the Federal Food, Drug, and Cosmetic Act.
    (e) Therefore, all exemptions from the provisions of section 409 of 
the act for use of antibiotics in food-producing animals based on 
sanctions or approvals granted prior to enactment of the Food Additives 
Amendment of 1958 (Pub. L. 85-929; 72 Stat. 1784) will be revoked and 
the uses which are concluded to be safe will be covered by food additive 
regulations. On those products for which there are inadequate residue 
data, actions will be initiated to withdraw approval of new-drug 
applications under the provisions of section 505 of the act. Antibiotic 
preparations, other than those for topical and ophthalmic application in 
food-producing animals, which are not covered by food additive 
regulations will be subject to regulatory action within 180 days after 
publication of the forthcoming revocation order.
    (f) Because of the variation in the period of time that antibiotic 
residues may remain in edible products from treated animals, all 
injectable, intramammary infusion, intrauterine, and oral preparations, 
including medicated premixes intended for use in food-producing animals, 
are deemed to be new drugs as well as food additives.

[40 FR 13807, Mar. 27, 1975, as amended at 54 FR 18280, Apr. 28, 1989; 
64 FR 403, Jan. 5, 1999]



Sec. 510.112  Antibiotics used in veterinary medicine and for 
nonmedical purposes; required data.

    (a) An ad hoc committee, Committee on the Veterinary Medical and 
Nonmedical Uses of Antibiotics, was

[[Page 76]]

formed by the Food and Drug Administration to study, and advise the 
Commissioner on, the use of antibiotics in veterinary medicine and for 
various nonmedical purposes as such uses may affect the enforcement of 
the Federal Food, Drug, and Cosmetic Act with respect to the safety and 
effectiveness of such substances. A copy of the report may be obtained 
from the Food and Drug Administration, Office of Public Affairs, Room 
15-05, Parklawn Building, 5600 Fishers Lane, Rockville, MD 20857.
    (b) On the basis of the report of the Committee and other 
information, sponsors of drugs containing any antibiotic intended for 
use in food-producing animals shall submit data for determining whether 
or not such antibiotics and their metabolites are present as residues in 
edible tissues, milk, and eggs from treated animals; however, in the 
case of a drug for which such data have already been submitted and for 
which a regulation has been promulgated under section 409 of the act, 
only such data as has been accumulated since the issuance of the 
regulation need be submitted.
    (c) The required data shall be submitted within 180 days of the date 
of publication of this section in the Federal Register; except that in 
the case of data on intramammary infusion preparations the data shall be 
submitted within 60 days of such publication. Data demonstrating the 
absence in milk of residues of intramammary infusion preparations when 
used as directed in their labeling are needed within the 60-day period 
because of the importance of milk in the human diet.
    (d) Regulatory proceedings including revocation of prior sanctions, 
or actions to suspend or amend new drug or antibiotic approvals granted 
prior to passage of the Food Additives Amendment of 1958 (72 Stat. 
1784), may be initiated with regard to the continued marketing of any 
antibiotic preparation on which the required information is not 
submitted within the period of time prescribed by paragraph (c) of this 
section.
    (e) Questions relating to the acceptability of proposed research 
protocols and assay methods for determining the amount of antibiotic 
residues in food should be directed to the Director, Center for 
Veterinary Medicine, Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855.

[40 FR 13807, Mar. 27, 1975, as amended at 46 FR 8460, Jan. 27, 1981; 54 
FR 18280, Apr. 28, 1989; 57 FR 6475, Feb. 25, 1992]

Subpart C [Reserved]



                      Subpart D_Records and Reports



Sec. 510.301  Records and reports concerning experience with animal
feeds bearing or containing new animal drugs for which an approved
medicated feed mill license application is in effect.
          

    Records and reports of clinical and other experience with the new 
animal drug will be maintained and reported, appropriately identified 
with the new animal drug application(s) or index listing(s) to which 
they relate, to the Center for Veterinary Medicine in duplicate in 
accordance with the following:
    (a) Immediately upon receipt by the applicant, complete records or 
reports covering information of the following kinds:
    (1) Information concerning any mixup in the new animal drug or its 
labeling with another article.
    (2) Information concerning any bacteriological or any significant 
chemical, physical, or other change or deterioration in the drug, or any 
failure of one or more distributed batches of the drug to meet the 
specifications established for it in the new animal drug application or 
request for determination of eligibility for indexing.
    (b) As soon as possible, and in any event within 15 working days of 
its receipt by the applicant, complete records or reports concerning any 
information of the following kinds:
    (1) Information concerning any unexpected side effect, injury, 
toxicity, or sensitivity reaction or any unexpected incidence or 
severity thereof associated with clinical uses, studies, investigations, 
or tests, whether or not determined to be attributable to the new animal 
drug, except that this requirement shall not apply to the submission of 
information described in a written communication to the applicant from

[[Page 77]]

the Food and Drug Administration as types of information that may be 
submitted at other designated intervals. Unexpected as used in this 
paragraph refers to conditions or developments not previously submitted 
as part of the new animal drug application or in support of the index 
listing or not encountered during clinical trials of the drug, or 
conditions or developments occurring at a rate higher than shown by 
information previously submitted as part of the new animal drug 
application or in support of the index listing or at a rate higher than 
encountered during such clinical trials.
    (2) Information concerning any unusual failure of the new animal 
drug to exhibit its expected pharmacological activity.

[40 FR 13807, Mar. 27, 1975, as amended at 54 FR 18280, Apr. 28, 1989; 
72 FR 69121, Dec. 6, 2007]



Sec. 510.305  Maintenance of copies of approved medicated feed mill
licenses to manufacture animal feed bearing or containing new animal 
drugs.

    Each applicant shall maintain in a single accessible location:
    (a) A copy of the approved medicated feed mill license (Form FDA 
3448) on the premises of the manufacturing establishment; and
    (b) Approved or index listed labeling for each Type B and/or Type C 
feed being manufactured on the premises of the manufacturing 
establishment or the facility where the feed labels are generated.

[64 FR 63203, Nov. 19, 1999, as amended at 72 FR 69121, Dec. 6, 2007]



          Subpart E_Requirements for Specific New Animal Drugs



Sec. 510.410  Corticosteroids for oral, injectable, and ophthalmic 
use in animals; warnings and labeling requirements.

    (a) The Food and Drug Administration has received reports of side 
effects associated with the oral, injectable, and ophthalmic use of 
corticosteroid animal drugs. The use of these drugs administered orally 
or by injection has resulted in premature parturition when administered 
during the last trimester of pregnancy. Premature parturition may be 
followed by dystocia, fetal death, retained placenta, and metritis. 
Additionally, corticosteroids used in dogs, rabbits, and rodents during 
pregnancy have produced cleft palate in offspring. Use in dogs has 
resulted in other congenital anomalies, including deformed forelegs, 
phocomelia, and anasarca. Drugs subject to this section are required to 
carry the veterinary prescription legend and are subject to the labeling 
requirements of Sec. 201.105 of this chapter.
    (b) In view of these potentially serious side effects, the Food and 
Drug Administration has concluded that the labeling on or within 
packaged corticosteroid-containing preparations intended for animal use 
shall bear conspicuously the following warning statement:

    Warning: Clinical and experimental data have demonstrated that 
corticosteroids administered orally or by injection to animals may 
induce the first stage of parturition if used during the last trimester 
of pregnancy and may precipitate premature parturition followed by 
dystocia, fetal death, retained placenta, and metritis.
    Additionally, corticosteroids administered to dogs, rabbits, and 
rodents during pregnancy have resulted in cleft palate in offspring. 
Corticosteroids administered to dogs during pregnancy have also resulted 
in other congenital anomalies, including deformed forelegs, phocomelia, 
and anasarca.

[49 FR 48535, Dec. 13, 1984]



Sec. 510.440  Injectable iron preparations.

    There has been an increasing interest in the use of injectable iron 
compounds for the prevention or treatment of iron-deficiency anemia in 
animals. Although some such preparations have been shown to be safe, 
such articles are regarded as new animal drugs within the meaning of the 
Federal Food, Drug, and Cosmetic Act. Accordingly, an approved new 
animal drug application is required prior to the marketing of such 
preparations within the jurisdiction of the act. In addition to the need 
for demonstrating the safety of such articles, the labeling of such 
preparations should not only recommend appropriate dosages of iron but 
also declare the amount (in milligrams) of available iron (Fe) per 
milliliter of the subject product.

[[Page 78]]



Sec. 510.455  Requirements for free-choice medicated feeds.

    (a) What is free-choice medicated feed? For the purpose of this 
part, free-choice medicated feed is medicated feed that is placed in 
feeding or grazing areas and is not intended to be consumed fully at a 
single feeding or to constitute the entire diet of the animal. Free-
choice feeds include, but are not limited to, medicated blocks 
(agglomerated feed compressed or rendered into a solid mass and cohesive 
enough to hold its form), mineral mixes, and liquid feed tank 
supplements (``lick tank'' supplements) containing one or more new 
animal drugs. The manufacture of medicated free-choice feeds is subject 
to the current good manufacturing practice regulations in part 225 of 
this chapter for medicated feeds.
    (b) What is required for new animal drugs intended for use in free-
choice feed? Any new animal drug intended for use in free-choice feed 
must be approved for such use under section 512 of the Federal Food, 
Drug, and Cosmetic Act (the act) (21 U.S.C. 360(b)) or listed in the 
index under section 572 of the act (21 U.S.C. 360ccc-1). Such approvals 
under section 512 of the act must be:
    (1) An original new animal drug application (NADA),
    (2) A supplemental NADA, or
    (3) An abbreviated NADA.
    (c) What are the approval requirements under section 512 of the act 
for new animal drugs intended for use in free-choice feed? An approval 
under section 512 of the act for a Type A medicated article intended for 
use in free-choice feed must contain the following information:
    (1) Data, or reference to data in a master file (MF), showing that 
the target animal consumes the new animal drug in the Type C free-choice 
feed in an amount that is safe and effective (consumption/effectiveness 
data); and
    (2) Data, or reference to data in an MF, showing the relevant ranges 
of conditions under which the drug will be chemically and physically 
stable in the Type C free-choice feed under field conditions.
    (d) How are consumption/effectiveness and/or stability data to be 
submitted? The data must be submitted as follows:
    (1) Directly in the NADA, by a sponsor; and/or
    (2) To an MF that a sponsor may then reference in its NADA with 
written consent of the MF holder.
    (e) What will be stated in the published approval for a new animal 
drug intended for use in free-choice feed? The approval of a new animal 
drug intended for use in free-choice feed, as published in this 
subchapter, will include:
    (1) The formula and/or specifications of the free-choice medicated 
feed, where the owner of this information requests such publication, or
    (2) A statement that the approval has been granted for a proprietary 
formula and/or specifications.
    (f) When is a medicated feed mill license required for the 
manufacture of a free-choice medicated feed? An approved medicated feed 
mill license is required for the manufacture of the following types of 
feeds:
    (1) All free-choice medicated feeds that contain a Category II drug, 
and
    (2) Free-choice medicated feeds that contain a Category I drug and 
use a proprietary formula and/or specifications.

[69 FR 30197, May 27, 2004, as amended at 72 FR 69121, Dec. 6, 2007]

Subpart F [Reserved]



               Subpart G_Sponsors of Approved Applications



Sec. 510.600  Names, addresses, and drug labeler codes of sponsors 
of approved applications.

    (a) Section 512(i) of the act requires publication of names and 
addresses of sponsors of approved applications for new animal drugs.
    (b) In this section each name and address is identified by a 
numerical drug labeler code. The labeler codes identify the sponsors of 
the new animal drug applications associated with the regulations 
published pursuant to section 512(i) of the act. The codes appear in the 
appropriate regulations and serve as a reference to the names and 
addresses listed in this section. The drug labeler code is established 
pursuant to section 510 of the act.

[[Page 79]]

    (c) The names, addresses, and drug labeler codes of sponsors of 
approved new animal drug applications are as follows:

                  (1) Alphabetical Listing of Sponsors
------------------------------------------------------------------------
                                                           Drug labeler
                  Firm name and address                        code
------------------------------------------------------------------------
A & G Pharmaceuticals, Inc., 1030 West Commodore Blvd.,           057699
 Jackson, NJ 08527......................................
Accord Healthcare, Inc., 1009 Slater Rd., suite 210-B,            016729
 Durham, NC 27703.......................................
ADM Animal Nutrition, Inc., 1000 North 30th St., Quincy,          012286
 IL 62305-3115..........................................
Agri Laboratories, Ltd., P.O. Box 3103, St. Joseph, MO            057561
 64503..................................................
Agri-Tech, Inc., 4722 Broadway, Kansas City, MO 64112...          017762
Akorn Animal Health, Inc., 1925 West Field Ct., suite             059399
 300, Lake Forest, IL 60045.............................
Alexion Pharmaceuticals, Inc., 100 College St., New               069334
 Haven, CT 06510........................................
American Regent, Inc., Animal Health Division, Shirley,           010797
 NY 11967...............................................
Anika Therapeutics Inc., 236 West Cummings Park, Woburn,          060865
 MA 01801...............................................
Anzac Animal Health, LLC, 218 Millwell Dr., Suite B,              086073
 Maryland Heights, MO 63043.............................
AquaBounty Technologies, Inc., 2 Mill and Main Pl.,               086053
 Suite 395, Maynard, MA 01754...........................
Ark Sciences, Inc., 1101 East 33rd St., suite B304,               076175
 Baltimore, MD 21218....................................
Aurora Pharmaceutical, Inc., 1196 Highway 3 South,                051072
 Northfield, MN 55057-3009..............................
Axcentive SARL, Chemin de Champouse, Quartier Violesi,            086009
 13320 Bouc Bel Air, France.............................
B.L. Mitchell, Inc., 103 Hwy. 82 E., Leland, MS 38756...          067188
Bausch Health US, LLC, 400 Somerset Corporate Blvd.,              099207
 Bridgewater, NJ 08807..................................
Belcher Pharmaceuticals, LLC, 6911 Bryan Dairy Rd.,               062250
 Largo, FL 33777........................................
Bimeda Animal Health Ltd., 1B The Herbert Building, The           061133
 Park, Carrickmines, Dublin 18, Ireland.................
Boehringer Ingelheim Animal Health USA, Inc., 3239                000010
 Satellite Blvd., Duluth, GA 30096......................
Cephazone Pharma, LLC, 250 East Bonita Ave., Pomona, CA           068330
 91767..................................................
Ceva Sante Animale, 10 Avenue de la Ballasti[egrave]re,           013744
 33500 Libourne, France.................................
Chanelle Pharmaceuticals Manufacturing Ltd., Loughrea,            061651
 County Galway, Ireland.................................
Cronus Pharma Specialities India Private Ltd., Sy No-99/          069043
 1, GMR Hyderabad Aviation SEZ Ltd., Mamidipalli
 Village, Shamshabad Mandal, Ranga Reddy, Hyderabad
 Telangana 501218, India................................
Dechra, Ltd., Snaygill Industrial Estate, Keighley Rd.,           043264
 Skipton, North Yorkshire, BD23 2RW, United Kingdom.....
Dechra Veterinary Products LLC, 7015 College Blvd.,               017033
 Suite 525, Overland Park, KS 66211.....................
ECO LLC, 344 Nassau St., Princeton, NJ 08540............          066916
Elanco US Inc., 2500 Innovation Way, Greenfield, IN               058198
 46140..................................................
Farnam Companies, Inc., 301 West Osborn, Phoenix, AZ              017135
 85013-3928.............................................
Felix Pharmaceuticals Pvt. Ltd., 25-28 North Wall Quay,           086101
 Dublin 1, Ireland......................................
First Priority, Inc., 1590 Todd Farm Dr., Elgin, IL               058829
 60123..................................................
Fougera Pharmaceuticals, Inc., P.O. Box 2006, 60 Baylis           025463
 Rd., Melville, NY 11747................................
G. C. Hanford Manufacturing Co., P.O. Box 1017,                   010515
 Syracuse, NY 13201.....................................
GTC Biotherapeutics, Inc., 175 Crossing Blvd.,                    042976
 Framingham, MA 01702...................................
Halocarbon Products Corp., 6525 The Corners Pkwy., Suite          012164
 200, Peachtree Corners, GA 30092.......................
Happy Jack, Inc., Snow Hill, NC 28580...................          023851
Hemoglobin Oxygen Therapeutics, LLC, 674 Souder Rd.,              063075
 Souderton, PA 18964....................................
Heska Corp., 1825 Sharp Point Dr., Fort Collins, CO               063604
 80525..................................................
HQ Specialty Pharma Corp., 120 Rte. 17 North, suite 130,          042791
 Paramus, NJ 07652......................................
Huvepharma EOOD, 5th Floor, 3A Nikolay Haytov Str., 1113          016592
 Sofia, Bulgaria........................................
IMPAX Laboratories, Inc., 30831 Huntwood Ave., Hayward,           000115
 CA 94544...............................................
Intervet, Inc., 2 Giralda Farms, Madison, NJ 07940......          000061
Ivaoes Animal Health, 4300 SW 73rd Ave., suite 110,               086064
 Miami, FL 33155........................................
Jurox Pty. Ltd., 85 Gardiner St., Rutherford, NSW 2320,           049480
 Australia..............................................
Kindred Biosciences, Inc., 1555 Bayshore Hwy., Suite              086078
 200, Burlingame, CA 94010..............................
Kinetic Technologies, LLC, 961 Beasley St., suite 270,            051031
 Lexington, KY 40509....................................
LFB USA, Inc., 175 Crossing Blvd., Framingham, MA 01702.          086047
Lloyd, Inc., 604 W. Thomas Ave., Shenandoah, IA 51601...          061690
Med-Pharmex, Inc., 2727 Thompson Creek Rd., Pomona, CA            054925
 91767-1861.............................................
Mizner Bioscience LLC, 225 NE Mizner Blvd., Suite 760,            086039
 Boca Raton, FL 33432...................................
Modern Veterinary Therapeutics, LLC, 14343 SW 119th               015914
 Ave., Miami, FL 33186..................................
Mylan Institutional, Inc., 12720 Dairy Ashford Rd.,               051079
 Sugar Land, TX 77478...................................
Mylan Institutional LLC, 4901 Hiawatha Dr., Rockford, IL          063286
 61103..................................................
Natchez Animal Supply Co., 201 John R. Junkin Dr.,                049968
 Natchez, MS 39120......................................
Neogen Corp., 944 Nandino Blvd., Lexington, KY 40511....          059051
Norbrook Laboratories, Ltd., Station Works, Newry BT35            055529
 6JP, Northern Ireland..................................
Oasmia Pharmaceutical AB, Vallongatan 1, 75228 Uppsala,           052818
 Sweden.................................................
Orion Corp., Orionintie 1, 02200 Espoo, Finland.........          052483
Parnell Technologies Pty. Ltd., unit 4, 476 Gardeners             068504
 Rd., Alexandria, New South Wales 2015, Australia.......
Pegasus Laboratories, Inc., 8809 Ely Rd., Pensacola, FL           055246
 32514..................................................
Pharmaceutical Ventures, Ltd., P.O. Box D1400, Pomona,            050057
 NY 10970...............................................
Pharmacosmos, Inc., 776 Mountain Blvd., Watchung, NJ              042552
 07069..................................................
Pharmaq AS, Skogmo Industriomrade, N-7863 Overhalla,              015331
 Norway.................................................
Pharmgate Inc., 1800 Sir Tyler Dr., Wilmington, NC 28405          069254
Phibro Animal Health Corp., GlenPointe Centre East, 3d            066104
 floor, 300 Frank W. Burr Blvd., suite 21, Teaneck, NJ
 07666..................................................
Piramal Critical Care, Inc., 3850 Schelden Circle,                066794
 Bethlehem, PA 18017....................................
Piramal Enterprises Ltd., Ananta, Agastya Corporate               065085
 Park, Opp Fire Brigade, Kamani Junction, LBS Mag Kurla
 (West), Mumbai, 400070, India..........................

[[Page 80]]

 
Planalquimica Industrial Ltda., Rua das Magnolias nr.             060728
 2405, Jardim das Bandeiras, CEP 13053-120, Campinas,
 Sao Paulo, Brazil......................................
Purina Animal Nutrition LLC, 1080 County Road F West,             017800
 Shoreview, MN 55126-2910...............................
QBiotics Group Ltd., Suite 3A, Level 1, 165 Moggill Rd.,          086132
 Taringa, Queensland 4068, Australia....................
Quo Vademus, LLC, 277 Faison McGowan Rd., Kenansville,            076475
 NC 28349...............................................
Revivicor, Inc., a wholly owned subsidiary of United              086134
 Therapeutics Corp., 1700 Kraft Dr., Suite 2400,
 Blacksburg, VA 24060...................................
Ridley USA, Inc., 111 W Cherry St., Suite 500, Mankato,           067949
 MN 56001...............................................
Sergeant's Pet Care Products, Inc., 10077 S. 134th St.,           021091
 Omaha, NE 68138........................................
Sparhawk Laboratories, Inc., 12340 Santa Fe Trail Dr.,            058005
 Lenexa, KS 66215.......................................
Squire Laboratories, Inc., 100 Mill St., Revere, MA               017153
 02151..................................................
Summit Hill Laboratories, P.O. Box 535, Navesink, NJ              037990
 07752..................................................
Superior Equine Pharmaceuticals, Inc., Pleasant Grove,            027053
 UT 84062...............................................
Syndel USA, 1441 W. Smith Rd., Ferndale, WA 98248.......          050378
Taro Pharmaceuticals U.S.A., Inc., 3 Skyline Dr.,                 051672
 Hawthorne, NY 10532....................................
Therio, Inc., 8801 Anderson Ave., Manhattan, KS 66503...          052923
Thorn Bioscience LLC, 1044 East Chestnut St.,                     051330
 Louisville, KY 40204...................................
Union Agener, Inc., 1788 Lovers Ln., Augusta, GA 30901..          086106
United-AH II LLC, 322 S Main St., Sheridan, IN 46069....          051233
VetDC, Inc., 320 E. Vine Dr., suite 218, Fort Collins,            086072
 CO 80524...............................................
V[eacute]toquinol N.-A., Inc., 2000 chemin Georges,               059320
 Lavaltrie (PQ), Canada, J5T 3S5........................
V[eacute]toquinol USA, Inc., 4250 N. Sylvania Ave., Fort          017030
 Worth, TX 76137........................................
Virbac AH, Inc., PO Box 162059, Fort Worth, TX 76161....          051311
Wildcat Feeds, 215 NE Strait Ave., Topeka, KS 66616.....          086113
Wildlife Laboratories, Inc., 1230 W. Ash St., suite D,            053923
 Windsor, CO 80550......................................
Zoetis Inc., 333 Portage St., Kalamazoo, MI 49007.......          054771
------------------------------------------------------------------------


                    (2) Numerical Listing of Sponsors
------------------------------------------------------------------------
 Drug labeler
     code                         Firm name and address
------------------------------------------------------------------------
        000010  Boehringer Ingelheim Animal Health USA, Inc., 3239
                 Satellite Blvd., Duluth, GA 30096.
        000061  Intervet, Inc., 2 Giralda Farms, Madison, NJ 07940.
        000115  IMPAX Laboratories, Inc., 30831 Huntwood Ave., Hayward,
                 CA 94544.
        010515  G. C. Hanford Manufacturing Co., P.O. Box 1017,
                 Syracuse, NY 13201.
        010797  American Regent, Inc., Animal Health Division, Shirley,
                 NY 11967.
        012164  Halocarbon Products Corp., 6525 The Corners Pkwy., Suite
                 200, Peachtree Corners, GA 30092.
        012286  ADM Animal Nutrition, Inc., 1000 North 30th St., Quincy,
                 IL 62305-3115.
        012578  Janssen Pharmaceutica NV, Turnhoutseweg 30, B-2340
                 Beerse, Belgium.
        013744  Ceva Sante Animale, 10 Avenue de la Ballasti[egrave]re,
                 33500 Libourne, France.
        015331  Pharmaq AS, Skogmo Industriomrade, N-7863 Overhalla,
                 Norway.
        015914  Modern Veterinary Therapeutics, LLC, 14343 SW 119th
                 Ave., Miami, FL 33186.
        016592  Huvepharma EOOD, 5th Floor, 3A Nikolay Haytov Str., 1113
                 Sofia, Bulgaria.
        016729  Accord Healthcare, Inc., 1009 Slater Rd., suite 210-B,
                 Durham, NC 27703.
        017030  V[eacute]toquinol USA, Inc., 4250 N. Sylvania Ave., Fort
                 Worth, TX 76137.
        017033  Dechra Veterinary Products LLC, 7015 College Blvd.,
                 Suite 525, Overland Park, KS 66211.
        017135  Farnam Companies, Inc., 301 West Osborn, Phoenix, AZ
                 85013-3928.
        017153  Squire Laboratories, Inc., 100 Mill St., Revere, MA
                 02151.
        017762  Agri-Tech, Inc., 4722 Broadway, Kansas City, MO 64112.
        017800  Purina Animal Nutrition, 1080 County Road F West,
                 Shoreview, MN 55126-2910.
        021091  Sergeant's Pet Care Products, Inc., 10077 S. 134th St.,
                 Omaha, NE 68138.
        023851  Happy Jack, Inc., Snow Hill, NC 28580.
        025463  Fougera Pharmaceuticals, Inc., P.O. Box 2006, 60 Baylis
                 Rd., Melville, NY 11747.
        027053  Superior Equine Pharmaceuticals, Inc., Pleasant Grove,
                 UT 84062.
        037990  Summit Hill Laboratories, P.O. Box 535, Navesink, NJ
                 07752.
        042552  Pharmacosmos, Inc., 776 Mountain Blvd., Watchung, NJ
                 07069.
        042791  HQ Specialty Pharma Corp., 120 Rte. 17 North, suite 130,
                 Paramus, NJ 07652.
        042976  GTC Biotherapeutics, Inc., 175 Crossing Blvd.,
                 Framingham, MA 01702.
        043264  Dechra, Ltd., Snaygill Industrial Estate, Keighley Rd.,
                 Skipton, North Yorkshire, BD23 2RW, United Kingdom.
        049480  Jurox Pty. Ltd., 85 Gardiner St., Rutherford, NSW 2320,
                 Australia.
        049968  Natchez Animal Supply Co., 201 John R. Junkin Dr.,
                 Natchez, MS 39120.
        050057  Pharmaceutical Ventures, Ltd., P.O. Box D1400, Pomona,
                 NY 10970.
        050378  Syndel USA, 1441 W. Smith Rd., Ferndale, WA 98248.
        051031  Kinetic Technologies, LLC, 961 Beasley St., suite 270,
                 Lexington, KY 40509.
        051072  Aurora Pharmaceutical, Inc., 1196 Highway 3 South,
                 Northfield, MN 55057-3009.
        051079  Mylan Institutional, Inc., 12720 Dairy Ashford Rd.,
                 Sugar Land, TX 77478.
        051233  United-AH II LLC, 322 S Main St., Sheridan, IN 46069.
        051311  Virbac AH, Inc., PO Box 162059, Fort Worth, TX 76161.
        051330  Thorn Bioscience LLC, 1044 East Chestnut St.,
                 Louisville, KY 40204.
        051672  Taro Pharmaceuticals U.S.A., Inc., 3 Skyline Dr.,
                 Hawthorne, NY 10532.

[[Page 81]]

 
        052483  Orion Corp., Orionintie 1, 02200 Espoo, Finland.
        052818  Oasmia Pharmaceutical AB, Vallongatan 1, 75228 Uppsala,
                 Sweden.
        052923  Therio, Inc., 8801 Anderson Ave., Manhattan, KS 66503.
        053923  Wildlife Laboratories, Inc., 1230 W. Ash St., suite D,
                 Windsor, CO 80550.
        054771  Zoetis Inc., 333 Portage St., Kalamazoo, MI 49007.
        054925  Med-Pharmex, Inc., 2727 Thompson Creek Rd., Pomona, CA
                 91767-1861.
        055246  Pegasus Laboratories, Inc., 8809 Ely Rd., Pensacola, FL
                 32514.
        055529  Norbrook Laboratories, Ltd., Station Works, Newry BT35
                 6JP, Northern Ireland.
        057561  Agri Laboratories, Ltd., P.O. Box 3103, St. Joseph, MO
                 64503.
        057699  A & G Pharmaceuticals, Inc., 1030 West Commodore Blvd.,
                 Jackson, NJ 08527.
        058005  Sparhawk Laboratories, Inc., 12340 Santa Fe Trail Dr.,
                 Lenexa, KS 66215.
        058198  Elanco US Inc., 2500 Innovation Way, Greenfield, IN
                 46140.
        058829  First Priority, Inc., 1590 Todd Farm Dr., Elgin, IL
                 60123.
        059051  Neogen Corp., 944 Nandino Blvd., Lexington, KY 40511.
        059320  V[eacute]toquinol N.-A., Inc., 2000 chemin Georges,
                 Lavaltrie (PQ), Canada, J5T 3S5.
        059399  Akorn Animal Health, Inc., 1925 West Field Ct., suite
                 300, Lake Forest, IL 60045.
        060728  Planalquimica Industrial Ltda., Rua das Magnolias nr.
                 Jardim das Bandeiras, CEP 13053-120, Campinas, Sao
                 Alto, Brazil.
        060865  Anika Therapeutics Inc., 236 West Cummings Park, Woburn,
                 MA 01801.
        061133  Bimeda Animal Health Ltd., 1B The Herbert Building, The
                 Park, Carrickmines, Dublin 18, Ireland.
        061651  Chanelle Pharmaceuticals Manufacturing Ltd., Loughrea,
                 County Galway, Ireland.
        061690  Lloyd, Inc., 604 W. Thomas Ave., Shenandoah, IA 51601.
        062250  Belcher Pharmaceuticals, LLC, 6911 Bryan Dairy Rd.,
                 Largo, FL 33777.
        062794  Mylan Bertek Pharmaceuticals, Inc., 12720 Dairy Ashford,
                 Sugar Land, TX 77478.
        063075  Hemoglobin Oxygen Therapeutics, LLC, 674 Souder Rd.,
                 Souderton, PA 18964.
        063286  Mylan Institutional, LLC, 4901 Hiawatha Dr., Rockford,
                 IL 61103.
        063604  Heska Corp., 1825 Sharp Point Dr., Fort Collins, CO
                 80525.
        065085  Piramal Enterprises Ltd., Ananta, Agastya Corporate
                 Park, Opp Fire Brigade, Kamani Junction, LBS Mag Kurla
                 (West), Mumbai, 400070, India.
        066104  Phibro Animal Health Corp., GlenPointe Centre East, 3d
                 floor, 300 Frank W. Burr Blvd., suite 21, Teaneck, NJ
                 07666.
        066794  Piramal Critical Care, Inc., 3850 Schelden Circle,
                 Bethlehem, PA 18017.
        066916  ECO LLC, 344 Nassau St., Princeton, NJ 08540.
        067188  B.L. Mitchell, Inc., 103 Hwy. 82 E., Leland, MS 38756.
        067949  Ridley USA, Inc., 111 W Cherry St., Suite 500, Mankato,
                 MN 56001.
        068330  Cephazone Pharma, LLC, 250 East Bonita Ave., Pomona, CA
                 91767.
        068504  Parnell Technologies Pty. Ltd., unit 4, 476 Gardeners
                 Rd., Alexandria, New South Wales 2015, Australia.
        069043  Cronus Pharma Specialities India Private Ltd., Sy No-99/
                 1, GMR Hyderabad Aviation SEZ Ltd., Mamidipalli
                 Village, Shamshabad Mandal, Ranga Reddy, Hyderabad
                 Telangana 501218, India.
        069254  Pharmgate Inc., 1800 Sir Tyler Dr., Wilmington, NC
                 28405.
        069334  Alexion Pharmaceuticals, Inc., 100 College St., New
                 Haven, CT 06510.
        076175  Ark Sciences, Inc., 1101 East 33rd St., suite B304,
                 Baltimore, MD 21218.
        076475  Quo Vademus, LLC, 277 Faison McGowan Rd., Kenansville,
                 NC 28349.
        086009  Axcentive SARL, Chemin de Champouse, Quartier Violesi,
                 13320 Bouc Bel Air, France.
        086039  Mizner Bioscience LLC, 225 NE Mizner Blvd., Suite 760,
                 Boca Raton, FL 33432.
        086047  LFB USA, Inc., 175 Crossing Blvd., Framingham, MA 01702.
        086053  AquaBounty Technologies, Inc., 2 Mill and Main Pl.,
                 Suite 395, Maynard, MA 01754.
        086064  Ivaoes Animal Health, 4300 SW 73rd Ave., suite 110,
                 Miami, FL 33155.
        086072  VetDC, Inc., 320 E Vine Dr., suite 218, Fort Collins, CO
                 80524.
        086073  Anzac Animal Health, LLC, 218 Millwell Dr., Suite B,
                 Maryland Heights, MO 63043.
        086078  Kindred Biosciences, Inc., 1555 Bayshore Hwy., Suite
                 200, Burlingame, CA 94010.
        086101  Felix Pharmaceuticals Pvt. Ltd., 25-28 North Wall Quay,
                 Dublin 1, Ireland.
        086106  Union Agener, Inc., 1788 Lovers Ln., Augusta, GA 30901.
        086113  Wildcat Feeds, 215 NE Strait Ave., Topeka, KS 66616.
        086132  QBiotics Group Ltd., Suite 3A, Level 1, 165 Moggill Rd.,
                 Taringa, Queensland 4068, Australia.
        086134  Revivicor, Inc., a wholly owned subsidiary of United
                 Therapeutics Corp., 1700 Kraft Dr., Suite 2400,
                 Blacksburg, VA 24060.
        099207  Bausch Health US, LLC, 400 Somerset Corporate Blvd.,
                 Bridgewater, NJ 08807.
------------------------------------------------------------------------


[40 FR 13807, Mar. 27, 1975]

    Editorial Notes: 1. For Federal Register citations affecting Sec. 
510.600, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and at www.govinfo.gov.

    2. At 77 FR 46613, Aug. 6, 2012, Sec. 510.600 was amended by 
removing the entry for ``012758'' in the table in paragraph (c)(2); 
however, the amendment could not be incorporated because ``012758'' 
didn't exist.

[[Page 82]]



PART 511_NEW ANIMAL DRUGS FOR INVESTIGATIONAL USE--Table of Contents



Sec.
511.1 New animal drugs for investigational use exempt from section 
          512(a) of the Federal Food, Drug, and Cosmetic Act.
511.3 Definitions.

    Authority: 21 U.S.C. 321, 351, 352, 353, 360b, 371.



Sec. 511.1  New animal drugs for investigational use exempt from
section 512(a) of the Federal Food, Drug, and Cosmetic Act.

    (a) New animal drugs for tests in vitro and in laboratory research 
animals. (1) A shipment or other delivery of a new animal drug or animal 
feed bearing or containing a new animal drug intended solely for tests 
in vitro or in animals used only for laboratory research purposes shall 
be exempt from section 512 (a) and (m) of the act if it is labeled as 
follows:

    Caution. Contains a new animal drug for investigational use only in 
laboratory research animals or for tests in vitro. Not for use in 
humans.

    (2) The person distributing or causing the distribution of new 
animal drugs for tests in vitro or in animals used only for laboratory 
research purposes under this exemption shall use due diligence to assure 
that the consignee is regularly engaged in conducting such tests and 
that the shipment of the new animal drug will actually be used for tests 
in vitro or in animals used only for laboratory research.
    (3) The person who introduced such shipment or who delivered the new 
animal drug for introduction into interstate commerce shall maintain 
adequate records showing the name and post office address of the expert 
or expert organization to whom the new animal drug is shipped and the 
date, quantity, and batch or code mark of each shipment and delivery for 
a period of 2 years after such shipment and delivery. Upon the request 
of a properly authorized employee of the Department at reasonable times, 
he shall make such records available for inspection and copying.
    (4) The exemption allowed in this paragraph shall not apply to any 
new animal drug intended for in vitro use in the regular course of 
diagnosing or treating disease, including antibacterial sensitivity 
discs impregnated with any new animal drug or drugs, which discs are 
intended for use in determining susceptibility of microorganisms to the 
new animal drug or drugs.
    (b) New animal drugs for clinical investigation in animals. A 
shipment or other delivery of a new animal drug or an animal feed 
containing a new animal drug intended for clinical investigational use 
in animals shall be exempt from section 512(a) and (m) of the act if all 
the following conditions are met:
    (1) The label shall bear the statements:

    Caution. Contains a new animal drug for use only in investigational 
animals in clinical trials. Not for use in humans. Edible products of 
investigational animals are not to be used for food unless authorization 
has been granted by the U.S. Food and Drug Administration or by the U.S. 
Department of Agriculture.

    In the case of containers too small or otherwise unable to 
accommodate a label with sufficient space to bear the caution statements 
required by paragraph (a) or (b) of this section, the statements may be 
included on the carton label and other labeling on or within the package 
from which the new animal drug is to be dispensed.
    (2) The person or firm distributing or causing the distribution of 
the new animal drug or animal feed containing a new animal drug shall 
use due diligence to assure that the new animal drug or animal feed 
containing a new animal drug will actually be used for tests in animals 
and is not used in humans.
    (3) The person who introduced such shipment or who delivered the new 
animal drug or animal feed containing a new animal drug for introduction 
into interstate commerce shall maintain adequate records showing the 
name and post office address of the investigator to whom the new animal 
drug or animal feed containing a new animal drug is shipped and the 
date, quantity, and batch or code mark of each shipment and delivery for 
a period of 2 years after such shipment and delivery. Upon the request 
of a properly authorized employee of the Department at reasonable times, 
such records shall be

[[Page 83]]

made available for inspection and copying.
    (4) Prior to shipment of the new animal drug for clinical tests in 
animals, the sponsor of the investigation shall submit in triplicate to 
FDA a ``Notice of Claimed Investigational Exemption for a New Animal 
Drug'' including a signed statement containing the following 
information:
    (i) The identity of the new animal drug.
    (ii) All labeling and other pertinent information to be supplied to 
the investigators. When such pertinent information includes nonclinical 
laboratory studies, the information shall include, with respect to each 
nonclinical study, either a statement that the study was conducted in 
compliance with the requirements set forth in part 58 of this chapter, 
or, if the study was not conducted in compliance with such regulations, 
a brief statement of the reason for the noncompliance.
    (iii) The name and address of each clinical investigator.
    (iv) The approximate number of animals to be treated (or if not 
available, the amount of new animal drug to be shipped).
    (v) If the new animal drug is given to food-producing animals, the 
statement shall contain the following additional information:
    (a) A commitment that the edible products from such animals shall 
not be used for food without prior authorization in accordance with the 
provisions prescribed in this section.
    (b) Approximate dates of the beginning and end of the experiment or 
series of experiments.
    (c) The maximum daily dose(s) to be administered to a given species, 
the size of animal, maximum duration of administration, method(s) of 
administration, and proposed withdrawal time, if any.
    (vi) If a sponsor has transferred any obligations for the conduct of 
any clinical study to a contract research organization, a statement 
containing the name and address of the contract research organization, 
identification of the clinical study, and a listing of the obligations 
transferred. If all obligations governing the conduct of the study have 
been transferred, a general statement of this transfer--in lieu of a 
listing of the specific obligations transferred--may be submitted.
    (5) Authorization for use of edible products derived from a treated 
food-producing animal may be granted under the provisions of this 
section and when the following specified conditions are met, except that 
in the case of an animal administered any unlicensed experimental 
veterinary biological product regulated under the viruses, serums, 
toxins statute (21 U.S.C., chapter V, sec. 151 et seq. ) the product 
shall be exempt from the requirements of this section when U.S. 
Department of Agriculture approval has been obtained as provided in 9 
CFR 103.2. Conditional authorization may be granted in advance of 
identification of the name(s) and address(es) of the clinical 
investigator(s) as required by paragraph (b)(4)(iii) of this section. 
Information required for authorization shall include, in addition to all 
other requirements of this section, the following:
    (i) Data to show that consumption of food derived from animals 
treated at the maximum levels with the minimum withdrawal periods, if 
any, specified in accordance with paragraph (b)(4)(v)(c) of this 
section, will not be inconsistent with the public health; or
    (ii) Data to show that food derived from animals treated at the 
maximum levels and with the minimum withdrawal periods, if any, 
specified in accordance with paragraph (b)(4)(v)(c) of this section, 
does not contain drug residues or metabolites.
    (iii) The name and location of the packing plant where the animals 
will be processed, except that this requirement may be waived, on 
request, by the terms of the authorization.

Authorizations granted under this paragraph do not exempt 
investigational animals and their products from compliance with other 
applicable inspection requirements. Any person who contests a refusal to 
grant such authorization shall have an opportunity for a regulatory 
hearing before FDA pursuant to part 16 of this chapter.

[[Page 84]]

    (6) On written request of FDA, the sponsor shall submit any 
additional information reported to or otherwise received by him with 
respect to the investigation deemed necessary to facilitate a 
determination whether there are grounds in the interest of public health 
for terminating the exemption.
    (7) The sponsor shall assure himself that the new animal drug is 
shipped only to investigators who:
    (i) Are qualified by scientific training and/experience to evaluate 
the safety and/or effectiveness of the new animal drug.
    (ii) Shall maintain complete records of the investigations, 
including complete records of the receipt and disposition of each 
shipment or delivery of the new animal drug under investigation. Copies 
of all records of the investigation shall be retained by the 
investigator for 2 years after the termination of the investigation or 
approval of a new animal drug application.
    (iii) Shall furnish adequate and timely reports of the investigation 
to the sponsor.
    (8) The sponsor:
    (i) Shall retain all reports received from investigators for 2 years 
after the termination of the investigation or approval of a new animal 
drug application and make such reports available to a duly authorized 
employee of the Department for inspection at all reasonable times.
    (ii) Shall provide for current monitoring of the investigation by a 
person qualified by scientific training and experience to evaluate 
information obtained from the investigation, and shall promptly 
investigate and report to FDA and to all investigators any findings 
associated with use of the new animal drug that may suggest significant 
hazards pertinent to the safety of the new animal drug.
    (iii) Shall not unduly prolong distribution of the new animal drug 
for investigational use.
    (iv) Shall not, nor shall any person acting for or on behalf of the 
sponsor, represent that the new animal drug is safe or effective for the 
purposes for which it is under investigation. This requirement is not 
intended to restrict the full exchange of scientific information.
    (v) Shall not commercially distribute nor test-market the new animal 
drug until a new animal drug application is approved pursuant to section 
512(c) of the act.
    (9) If the shipment or other delivery of the new animal drug is 
imported or offered for importation into the United States for clinical 
investigational use in animals, it shall also meet the following 
conditions:
    (i) The importer of all such shipments or deliveries is an agent of 
the foreign exporter residing in the United States or the ultimate 
consignee, which person has, prior to such shipments and deliveries, 
informed FDA of his intention to import the new animal drug as sponsor 
in compliance with the conditions prescribed in this subdivision; or
    (ii) The new animal drug is shipped directly to a scientific 
institution with adequate facilities and qualified personnel to conduct 
laboratory or clinical investigations and is intended solely for use in 
such institutions and which institution has submitted a statement as 
sponsor of the investigation.
    (10) The sponsor shall submit either a claim for categorical 
exclusion under Sec. 25.30 or Sec. 25.33 of this chapter or an 
environmental assessment under Sec. 25.40 of this chapter.
    (c) Disqualification of a clinical investigator. (1) If FDA has 
information indicating that an investigator (including a sponsor-
investigator) has repeatedly or deliberately failed to comply with the 
conditions of these exempting regulations or has repeatedly or 
deliberately submitted to FDA or to the sponsor false information in any 
required report, the Center for Veterinary Medicine will furnish the 
investigator written notice of the matter complained of and offer the 
investigator an opportunity to explain the matter in writing, or, at the 
option of the investigator, in an informal conference. If an explanation 
is offered and accepted by the Center for Veterinary Medicine, the 
Center will discontinue the disqualification proceeding. If an 
explanation is offered but not accepted by the Center for Veterinary 
Medicine, the investigator will be given an opportunity for a regulatory 
hearing under

[[Page 85]]

part 16 of this chapter on the question of whether the investigator is 
eligible to receive test articles under this part and eligible to 
conduct:
    (i) Any clinical investigation that supports an application for a 
research or marketing permit for products regulated by FDA; and
    (ii) Any nonclinical laboratory study intended to support an 
application for a research or marketing permit for a new animal drug.
    (2) After evaluating all available information, including any 
explanation presented by the investigator, if the Commissioner 
determines that the investigator has repeatedly or deliberately failed 
to comply with the conditions of the exempting regulations in this 
subchapter, or has repeatedly or deliberately submitted to FDA or to the 
sponsor false information in any required report, the Commissioner will 
notify the investigator and the sponsor of any investigation in which 
the investigator has been named as a participant that the investigator 
is not eligible to receive test articles under this part. The 
notification to the investigator and sponsor will provide a statement of 
the basis for such determination. The notification also will explain 
that an investigator determined to be ineligible to receive test 
articles under this part will be ineligible to conduct:
    (i) Any clinical investigation that supports an application for a 
research or marketing permit for products regulated by FDA, including 
drugs, biologics, devices, new animal drugs, foods, including dietary 
supplements, that bear a nutrient content claim or a health claim, 
infant formulas, food and color additives, and tobacco products; and
    (ii) Any nonclinical laboratory study intended to support an 
application for a research or marketing permit for a new animal drug.
    (3) Each application or submission to FDA under the provisions of 
this chapter containing data reported by an investigator who has been 
determined to be ineligible to receive FDA-regulated test articles is 
subject to examination to determine whether the investigator has 
submitted unreliable data that are essential to the continuation of an 
investigation or essential to the approval of a marketing application, 
or essential to the continued marketing of an FDA-regulated product.
    (4) If the Commissioner determines, after the unreliable data 
submitted by the investigator are eliminated from consideration, that 
the data remaining are inadequate to support a conclusion that it is 
reasonably safe to continue the investigation, the Commissioner will 
notify the sponsor, who shall have an opportunity for a regulatory 
hearing under part 16 of this chapter. If a danger to the public health 
exists, however, the Commissioner shall terminate the exemption 
immediately and notify the sponsor of the termination. In such case, the 
sponsor shall have an opportunity for a regulatory hearing before FDA 
under part 16 on the question of whether the exemption should be 
reinstated. The determination that an investigation may not be 
considered in support of a research or marketing application or a 
notification or petition submission does not, however, relieve the 
sponsor of any obligation under any other applicable regulation to 
submit to FDA the results of the investigation.
    (5) If the Commissioner determines, after the unreliable data 
submitted by the investigator are eliminated from consideration, that 
the continued approval of the product for which the data were submitted 
cannot be justified, the Commissioner will proceed to withdraw approval 
of the product in accordance with the applicable provisions of the 
relevant statutes.
    (6) An investigator who has been determined to be ineligible under 
paragraph (c)(2) of this section may be reinstated as eligible when the 
Commissioner determines that the investigator has presented adequate 
assurances that the investigator will employ all test articles, and will 
conduct any clinical investigation that supports an application for a 
research or marketing permit for products regulated by FDA and any 
nonclinical laboratory study intended to support an application for a 
research or marketing permit for a new animal drug, solely in compliance 
with the applicable provisions of this chapter.
    (d) Termination of exemption. If the Commissioner finds that:

[[Page 86]]

    (1) The sponsor of the investigation has failed to comply with any 
of the conditions for the exemption established under this section, or
    (2) The continuance of the investigation is unsafe or otherwise 
contrary to the public interest or the drug is being or has been used 
for purposes other than bona fide scientific investigation, he shall 
first notify the sponsor and invite his immediate correction. If the 
conditions of the exemption are not immediately met, the sponsor shall 
have an opportunity for a regulatory hearing before FDA pursuant of part 
16 of this chapter on whether the exemption should be terminated. If the 
exemption is terminated the sponsor shall recall or have destroyed the 
unused supplies of the new animal drug.
    (e) Statements and requests. ``Notice(s) of Claimed Investigational 
Exemption for a New Animal Drug'' and requests for authorization to use 
investigational animals and their products for food should be addressed 
to the Department of Health and Human Services, Food and Drug 
Administration, Center for Veterinary Medicine, 7500 Standish Pl., 
Rockville, MD 20855.
    (f) Contract research organizations. (1) For purposes of this part 
and part 514, contract research organization means a person that 
assumes, as an independent contractor with the sponsor, one or more of 
the obligations of a sponsor, e.g., design of a protocol, selection or 
monitoring of investigations, evaluation of reports, and preparation of 
materials to be submitted to FDA.
    (2) A sponsor may transfer responsibility for any or all of the 
obligations set forth in this part to a contract research organization. 
Any such transfer shall be in writing and, if not all obligations are 
transferred, shall describe each of the obligations being assumed by the 
contract research organization. If all obligations are transferred, a 
general statement that all obligations have been transferred is 
acceptable. Any obligation not covered by the written description shall 
be deemed not to have been transferred.
    (3) A contract research organization that assumes any obligation of 
a sponsor shall comply with the specific regulations in this chapter 
applicable to this obligation and shall be subject to the same 
regulatory action as a sponsor for failure to comply with any obligation 
assumed under these regulations. Thus, all references to sponsor in this 
part apply to a contract research organization to the extent that it 
assumes one or more obligations of the sponsor.
    (g) Index of legally marketed unapproved new animal drugs for minor 
species. All provisions of part 511 apply to new animal drugs for 
investigational use in support of indexing, as described in section 572 
of the act, subject to the provisions of Sec. 516.125 of this chapter.

[40 FR 13823, Mar. 27, 1975, as amended at 41 FR 48268, Nov. 2, 1976; 42 
FR 15675, Mar. 22, 1977; 50 FR 7517, Feb. 22, 1985; 50 FR 16668, Apr. 
26, 1985; 52 FR 8847, Mar. 19, 1987; 54 FR 18280, Apr. 28, 1989; 57 FR 
6475, Feb. 25, 1992; 62 FR 40599, July 29, 1997; 72 FR 69121, Dec. 6, 
2007; 77 FR 25359, Apr. 30, 2012; 82 FR 61446, Dec. 28, 2017]



Sec. 511.3  Definitions.

    As used in this part:
    Contract research organization means a person that assumes, as an 
independent contractor with the sponsor, one or more of the obligations 
of a sponsor, e.g., design of a protocol, selection or monitoring of 
investigations, evaluation of reports, and preparation of materials to 
be submitted to the Food and Drug Administration.
    Investigator means an individual who actually conducts a clinical 
investigation (i.e., under whose immediate direction the drug is 
administered or dispensed to a subject). In the event an investigation 
is conducted by a team of individuals, the investigator is the 
responsible leader of the team. ``Subinvestigator'' includes any other 
individual member of that team.
    Sponsor means a person who takes responsibility for and initiates a 
clinical investigation. The sponsor may be an individual or 
pharmaceutical company, governmental agency, academic institution, 
private organization, or other organization. The sponsor does not 
actually conduct the investigation unless the sponsor is a sponsor-
investigator. A person other than an individual that uses one or more of 
its own employees to conduct an investigation that it has

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initiated is a sponsor, not a sponsor-investigator, and the employees 
are investigators.
    Sponsor-Investigator means an individual who both initiates and 
conducts an investigation, and under whose immediate direction the 
investigational drug is administered or dispensed. The term does not 
include any person other than an individual. The requirements applicable 
to a sponsor-investigator under this part include both those applicable 
to an investigator and a sponsor.

[77 FR 25359, Apr. 30, 2012]



PART 514_NEW ANIMAL DRUG APPLICATIONS--Table of Contents



                      Subpart A_General Provisions

Sec.
514.1 Applications.
514.3 Definitions.
514.4 Substantial evidence.
514.5 Presubmission conferences.
514.6 Amended applications.
514.7 Withdrawal of applications without prejudice.
514.8 Supplements and other changes to an approved application.
514.11 Confidentiality of data and information in a new animal drug 
          application file.
514.12 Confidentiality of data and information in an investigational new 
          animal drug notice.
514.15 Untrue statements in applications.

            Subpart B_Administrative Actions on Applications

514.80 Records and reports concerning experience with approved new 
          animal drugs.
514.87 Annual reports for antimicrobial animal drug sales and 
          distribution.
514.100 Evaluation and comment on applications.
514.105 Approval of applications.
514.106 Approval of supplemental applications.
514.110 Reasons for refusing to file applications.
514.111 Refusal to approve an application.
514.115 Withdrawal of approval of applications.
514.116 Notice of withdrawal of approval of application.
514.117 Adequate and well-controlled studies.
514.120 Revocation of order refusing to approve an application or 
          suspending or withdrawing approval of an application.
514.121 Service of notices and orders.

                      Subpart C_Hearing Procedures

514.200 Notice of opportunity for hearing; notice of participation and 
          requests for hearing; grant or denial of hearing.
514.201 Procedures for hearings.

Subparts D-E [Reserved]

                        Subpart F_Judicial Review

514.235 Judicial review.

    Authority: 21 U.S.C. 321, 331, 351, 352, 354, 356a, 360b, 360ccc, 
371, 379e, 381.

    Source: 40 FR 13825, Mar. 27, 1975, unless otherwise noted.



                      Subpart A_General Provisions



Sec. 514.1  Applications.

    (a) Applications to be filed under section 512(b) of the act shall 
be submitted in the form and contain the information described in 
paragraph (b) of this section, as appropriate to support the particular 
submission. If any part of the application is in a foreign language, an 
accurate and complete English translation shall be appended to such 
part. Translations of literature printed in a foreign language shall be 
accompanied by copies of the original publication. The application must 
be signed by the applicant or by an authorized attorney, agent, or 
official. If the applicant or such authorized representative does not 
reside or have a place of business within the United States, the 
application must also furnish the name and post office address of, and 
must be countersigned by, an authorized attorney, agent, or official 
residing or maintaining a place of business within the United States. 
Pertinent information may be incorporated in, and will be considered as 
part of, an application on the basis of specific reference to such 
information, including information submitted under the provisions of 
Sec. 511.1 of this chapter, in the files of the Food and Drug 
Administration; however, the reference must be specific in identifying 
the information. Any reference to information furnished by a person 
other than the applicant may not be considered unless its use is 
authorized in a written statement signed by the person who submitted it.

[[Page 88]]

    (b) Applications for new animal drugs shall be submitted in 
triplicate and assembled in the manner prescribed by paragraph (b)(15) 
of this section, and shall include the following information, as 
appropriate to support the particular submission:
    (1) Identification. Whether the submission is an original or 
supplemental application; the name and the address of the applicant; the 
date of the application; the trade name(s) (if one has been proposed) 
and chemical name(s) of the new animal drug. Upon receipt, the 
application will be assigned a number NADA __, which shall be used for 
all correspondence with respect to the application.
    (2) Table of contents and summary. The application shall be 
organized in a cohesive fashion, shall contain a table of contents which 
identifies the data and other material submitted, and shall contain a 
well-organized summary and evaluation of the data in the following form:
    (i) Chemistry:
    (a) Chemical structural formula or description for any new animal 
drug substance.
    (b) Relationship to other chemically or pharmacologically related 
drugs.
    (c) Description of dosage form and quantitative composition.
    (ii) Scientific rationale and purpose the new animal drug is to 
serve:
    (a) Clinical purpose.
    (b) Highlights of laboratory studies: The reasons why certain types 
of studies were done or omitted as related to the proposed conditions of 
use and to information already known about this class of compounds. 
Emphasize any unusual or particularly significant pharmacological 
effects or toxicological findings.
    (c) Highlights of clinical studies: The rationale of the clinical 
study plan showing why types of studies were done, amended, or omitted 
as related to laboratory studies and prior clinical experience.
    (d) Conclusions: A short statement of conclusions combining the 
major points of effectiveness and safety as they relate to the use of 
the new animal drug.
    (3) Labeling. Three copies of each piece of all labeling to be used 
for the article (total of 9).
    (i) All labeling should be identified to show its position on, or 
the manner in which it is to accompany the market package.
    (ii) Labeling for nonprescription new animal drugs should include 
adequate directions for use by the layman under all conditions of use 
for which the new animal drug is intended, recommended, or suggested in 
any of the labeling or advertising sponsored by the applicant.
    (iii) Labeling for prescription veterinary drugs should bear 
adequate information for use under which veterinarians can use the new 
animal drug safely and for the purposes for which it is intended, 
including those purposes for which it is to be advertised or 
represented, in accord with Sec. 201.105 of this chapter.
    (iv) All labeling for prescription or nonprescription new animal 
drugs shall be submitted with any necessary use restrictions prominently 
and conspicuously displayed.
    (v) Labeling for new animal drugs intended for use in the 
manufacture of medicated feeds shall include:
    (a) Specimens of labeling to be used for such new animal drug with 
adequate directions for the manufacture and use of finished feeds for 
all conditions for which the new animal drug is intended, recommended, 
or suggested in any of the labeling, including advertising, sponsored by 
the applicant. Ingredient labeling may utilize collective names as 
provided in Sec. 501.110 of this chapter.
    (b) Representative labeling proposed to be used for Type B and Type 
C medicated feeds containing the new animal drug.
    (vi) Draft labeling may be submitted for preliminary consideration 
of an application. Final printed labeling will ordinarily be required 
prior to approval of an application. Proposed advertising for veterinary 
prescription drugs may be submitted for comment or approval.
    (4) Components and composition. A complete list of all articles used 
for production of the new animal drug including a full list of the 
composition of each article:

[[Page 89]]

    (i) A full list of the articles used as components of the new animal 
drug. This list should include all substances used in the synthesis, 
extraction, or other method of preparation of any new animal drug and in 
the preparation of the finished dosage form, regardless of whether they 
undergo chemical change or are removed in the process. Each component 
should be identified by its established name, if any, or complete 
chemical name, using structural formulas when necessary for specific 
identification. If any proprietary name is used, it should be followed 
by a complete quantitative statement of composition. Reasonable 
alternatives for any listed component may be specified.
    (ii) A full statement of the composition of the new animal drug. The 
statement shall set forth the name and amount of each ingredient, 
whether active or not, contained in a stated quantity of the new animal 
drug in the form in which it is to be distributed (for example, amount 
per tablet or milliliter) and a batch formula representative of that to 
be employed for the manufacture of the finished dosage form. All 
components should be included in the batch formula regardless of whether 
they appear in the finished product. Any calculated excess of an 
ingredient over the label declaration should be designated as such and 
percent excess shown. Reasonable variation may be specified.
    (iii) If it is a new animal drug produced by fermentation:
    (a) Source and type of microorganism used to produce the new animal 
drug.
    (b) Composition of media used to produce the new animal drug.
    (c) Type of precursor used, if any, to guide or enhance production 
of the antibiotic during fermentation.
    (d) Name and composition of preservative, if any, used in the broth.
    (e) A complete description of the extraction and purification 
processes including the names and compositions of the solvents, 
precipitants, ion exchange resins, emulsifiers, and all other agents 
used.
    (f) If the new animal drug is produced by a catalytic hydrogenation 
process (such as tetracycline from chlortetracycline), a complete 
description of each chemical reaction with graphic formulas used to 
produce the new animal drug, including the names of the catalyst used, 
how it is removed, and how the new animal drug is extracted and 
purified.
    (5) Manufacturing methods, facilities, and controls. A full 
description of the methods used in, and the facilities and controls used 
for, the manufacture, processing, and packing of the new animal drug. 
This description should include full information with respect to any new 
animal drug in sufficient detail to permit evaluation of the adequacy of 
the described methods of manufacture, processing, and packing, and the 
described facilities and controls to determine and preserve the 
identity, strength, quality, and purity of the new animal drug, and the 
following:
    (i) If the applicant does not himself perform all the manufacturing, 
processing, packaging, labeling, and control operations for any new 
animal drug, he shall: Identify each person who will perform any part of 
such operations and designate the part; and provide a signed statement 
from each such person fully describing, directly or by reference, the 
methods, facilities, and controls he will use in his part of the 
operation. The statement shall include a commitment that no changes will 
be made without prior approval by the Food and Drug Administration, 
unless permitted under Sec. 514.8.
    (ii) A description of the qualifications, including educational 
background and experience, of the technical and professional personnel 
who are responsible for assuring that the new animal drug has the 
identity, strength, quality, and purity it purports or is represented to 
possess, and a statement of their responsibilities.
    (iii) A description of the physical facilities including building 
and equipment used in manufacturing, processing, packaging, labeling, 
storage, and control operations.
    (iv) The methods used in the synthesis, extraction, isolation, or 
purification of any new animal drug. When the specifications and 
controls applied to such new animal drugs are inadequate in themselves 
to determine its identity, strength, quality, and purity,

[[Page 90]]

the methods should be described in sufficient detail, including 
quantities used, times, temperature, pH, solvents, etc., to determine 
these characteristics. Alternative methods or variations in methods 
within reasonable limits that do not affect such characteristics of the 
new animal drug may be specified. A flow sheet and indicated equations 
should be submitted when needed to explain the process.
    (v) Precautions to insure proper identity, strength, quality, and 
purity of the raw materials, whether active or not, including:
    (a) The specifications for acceptance and methods of testing for 
each lot of raw material.
    (b) A statement as to whether or not each lot of raw materials is 
given a serial number to identify it, and the use made of such numbers 
in subsequent plant operations.
    (vi) The instructions used in the manufacturing, processing, 
packaging, and labeling of each dosage form of the new animal drug, 
including:
    (a) The method of preparation of the master formula records and 
individual batch records and the manner in which these records are used.
    (b) The number of individuals checking weight or volume of each 
individual ingredient entering into each batch of the new animal drug.
    (c) A statement as to whether or not the total weight or volume of 
each batch is determined at any stage of the manufacturing process 
subsequent to making up a batch according to the formula card and, if 
so, at what stage and by whom it is done.
    (d) The precautions used in checking the actual package yield 
produced from a batch of the new animal drug with the theoretical yield. 
This should include a description of the accounting for such items as 
discards, breakage, etc., and the criteria used in accepting or 
rejecting batches of drugs in the event of an unexplained discrepancy.
    (e) The precautions used to assure that each lot of the new animal 
drug is packaged with the proper label and labeling, including 
provisions for labeling storage and inventory control.
    (f) Any special precautions used in the operations.
    (vii) The analytical controls used during the various stages of the 
manufacturing, processing, packaging, and labeling of the new animal 
drug, including a detailed description of the collection of samples and 
the analytical procedures to which they are subjected. The analytical 
procedures should be capable of determining the active components within 
a reasonable degree of accuracy and of assuring the identity of such 
components.
    (a) A description of practicable methods of analysis of adequate 
sensitivity to determine the amount of the new animal drug in the final 
dosage form should be included. The dosage form may be a finished 
pharmaceutical product, a Type A medicated article, a Type B or a Type C 
medicated feed, or a product for use in animal drinking water. Where two 
or more active ingredients are included, methods should be quantitative 
and specific for each active ingredient.
    (b) If the article is one that is represented to be sterile, the 
same information with regard to the manufacturing, processing, 
packaging, and the collection of samples of the drug should be given for 
sterility controls. Include the standards used for acceptance of each 
lot of the finished drug.
    (viii) An explanation of the exact significance of any batch control 
numbers used in the manufacturing, processing, packaging, and labeling 
of the new animal drug, including such control numbers that may appear 
on the label of the finished article. State whether these numbers enable 
determination of the complete manufacturing history of the product. 
Describe any methods used to permit determination of the distribution of 
any batch if its recall is required.
    (ix) Adequate information with respect to the characteristics of and 
the test methods employed for the container, closure, or other component 
parts of the drug package to assure their suitability for the intended 
use.
    (x) A complete description of, and data derived from, studies of the 
stability of the new animal drug in the final dosage form, including 
information showing the suitability of the analytical methods used. A 
description of

[[Page 91]]

any additional stability studies underway or planned. Stability data for 
the finished dosage form of the new animal drug in the container in 
which it is to be marketed, including any proposed multiple dose 
container, and, if it is to be put into solution at the time of 
dispensing, for the solution prepared as directed. If the new animal 
drug is intended for use in the manufacture of Type C medicated feed as 
defined in Sec. 558.3 of this chapter, stability data derived from 
studies in which representative formulations of the medicated feed 
articles are used. Similar data may be required for Type B medicated 
feeds as determined by the Food and Drug Administration on a case-by-
case basis. Expiration dates shall be proposed for finished 
pharmaceutical dosage forms and Type A medicated articles. If the data 
indicate that an expiration date is needed for Type B or Type C 
medicated feeds, the applicant shall propose such expiration date. If no 
expiration date is proposed for Type B or Type C medicated feeds, the 
applicant shall justify its absence with data.
    (xi) Additional procedures employed which are designed to prevent 
contamination and otherwise assure proper control of the product. An 
application may be refused unless it includes adequate information 
showing that the methods used in, and the facilities and controls used 
for, the manufacturing, processing, and packaging of the new animal drug 
are adequate to preserve its identity, strength, quality, and purity in 
conformity with good manufacturing practice and identifies each 
establishment, showing the location of the plant conducting these 
operations.
    (6) Samples. Samples of the new animal drug and articles used as 
components and information concerning them may be requested by the 
Center for Veterinary Medicine as follows:
    (i) Each sample shall consist of four identical, separately packaged 
subdivisions, each containing at least three times the amount required 
to perform the laboratory test procedures described in the application 
to determine compliance with its control specifications for identity and 
assays. Each of the samples submitted shall be appropriately packaged 
and labeled to preserve its characteristics, to identify the material 
and the quantity in each subdivision of the sample, and to identify each 
subdivision with the name of the applicant and the new animal drug 
application to which it relates. Included are:
    (a) A sample or samples of any reference standard and blank used in 
the procedures described in the application for assaying each new animal 
drug and other assayed components of the finished new animal drug.
    (b) A representative sample or samples of each strength of the 
finished dosage form proposed in the application and employed in the 
clinical investigations and a representative sample or samples of each 
new animal drug from the batch(es) employed in the production of such 
dosage form.
    (c) A representative sample or samples of finished market packages 
of each strength of the dosage form of the new animal drug prepared for 
initial marketing and, if any such sample is not from a representative 
commercial-scale production batch, such a sample from a representative 
commercial-scale production batch, and a representative sample or 
samples of each new animal drug from the batch(es) employed in the 
production of such dosage form, provided that in the case of new animal 
drugs marketed in large packages the sample should contain only three 
times a sufficient quantity of the new animal drug to allow for 
performing the control tests for drug identity and assays.
    (ii) The following information shall be included for the samples 
when requested:
    (a) For each sample submitted, full information regarding its 
identity and the origin of any new animal drug contained therein 
(including a statement whether it was produced on a laboratory, pilot-
plant, or full-production scale) and detailed results of all laboratory 
tests made to determine the identity, strength, quality, and purity of 
the batch represented by the sample, including assays.
    (b) For any reference standard submitted, a complete description of 
its preparation and the results of all laboratory tests on it. If the 
test methods used differed from those described in the application, full 
details of the

[[Page 92]]

methods employed in obtaining the reporting results.
    (7) Analytical methods for residues. Applications shall include a 
description of practicable methods for determining the quantity, if any, 
of the new animal drug in or on food, and any substance formed in or on 
food because of its use, and the proposed tolerance or withdrawal period 
or other use restrictions to ensure that the proposed use of this drug 
will be safe. When data or other adequate information establish that it 
is not reasonable to expect the new animal drug to become a component of 
food at concentrations considered unsafe, a regulatory method is not 
required.
    (i) The kind of information required by this subdivision may 
include: Complete experimental protocols for determining drug residue 
levels in the edible products, and the length of time required for 
residues to be eliminated from such products following the drug's use; 
residue studies conducted under appropriate (consistent with the 
proposed usage) conditions of dosage, time, and route of administration 
to show levels, if any, of the drug and/or its metabolites in test 
animals during and upon cessation of treatment and at intervals 
thereafter in order to establish a disappearance curve; if the drug is 
to be used in combination with other drugs, possible effects of 
interaction demonstrated by the appropriate disappearance curve or 
depletion patterns after drug withdrawal under appropriate (consistent 
with the proposed usage) conditions of dosage, time, and route of 
administration; if the drug is given in the feed or water, appropriate 
consumption records of the medicated feed or water and appropriate 
performance data in the treated animal; if the drug is to be used in 
more than one species, drug residue studies or appropriate metabolic 
studies conducted for each species that is food-producing. To provide 
these data, a sufficient number of birds or animals should be used at 
each sample interval. Appropriate use of labeled compounds (e.g. 
radioactive tracers), may be utilized to establish metabolism and 
depletion curves. Drug residue levels ordinarily should be determined in 
muscle, liver, kidney, and fat and where applicable, in skin, milk, and 
eggs (yolk and egg white). As a part of the metabolic studies, levels of 
the drug or metabolite should be determined in blood where feasible. 
Samples may be combined where necessary. Where residues are suspected or 
known to be present in litter from treated animals, it may be necessary 
to include data with respect to such residues becoming components of 
other agricultural commodities because of use of litter from treated 
animals.
    (ii) A new animal drug that has the potential to contaminate human 
food with residues whose consumption could present a risk of cancer to 
people must satisfy the requirements of subpart E of part 500 of this 
chapter.
    (8) Evidence to establish safety and effectiveness. (i) An 
application may be refused unless it contains full reports of adequate 
tests by all methods reasonably applicable to show whether or not the 
new animal drug is safe and effective for use as suggested in the 
proposed labeling.
    (ii) An application may be refused unless it includes substantial 
evidence of the effectiveness of the new animal drug as defined in Sec. 
514.4.
    (iii) An application may be refused unless it contains detailed 
reports of the investigations, including studies made on laboratory 
animals, in which the purpose, methods, and results obtained are clearly 
set forth of acute, subacute, and chronic toxicity, and unless it 
contains appropriate clinical laboratory results related to safety and 
efficacy. Such information should include identification of the person 
who conducted each investigation, a statement of where the 
investigations were conducted, and where the raw data are available in 
the application.
    (iv) All information pertinent to an evaluation of the safety and 
effectiveness of the new animal drug received or otherwise obtained by 
the applicant from any source, including information derived from other 
investigations or commercial marketing (for example, outside the United 
States), or reports in the scientific literature, both favorable and 
unfavorable, involving the new animal drug that is the subject of the 
application and related new animal drugs shall be submitted. An adequate 
summary may be acceptable in lieu of

[[Page 93]]

a reprint of a published report that only supports other data submitted. 
Include any evaluation of the safety or effectiveness of the new animal 
drug that has been made by the applicant's veterinary or medical 
department, expert committee, or consultants.
    (v) If the new animal drug is a combination of active ingredients or 
animal drugs, an application may be refused unless it includes 
substantial evidence of the effectiveness of the combination new animal 
drug as required in Sec. 514.4.
    (vi) An application shall include a complete list of the names and 
post office addresses of all investigators who received the new animal 
drug. This may be incorporated in whole or in part by reference to 
information submitted under the provisions of Sec. 511.1 of this 
chapter.
    (vii) Explain any omission of reports from any investigator to whom 
the investigational new animal drug has been made available. The 
unexplained omission of any reports of investigations made with the new 
animal drug by the applicant or submitted to him by an investigator or 
the unexplained omission of any pertinent reports of investigations or 
clinical experience received or otherwise obtained by the applicant from 
published literature or other sources that would bias an evaluation of 
the safety of the new animal drug or its effectiveness in use, 
constitutes grounds for the refusal or withdrawal of the approval of an 
application.
    (viii) If a sponsor has transferred any obligations for the conduct 
of any clinical study to a contract research organization, the 
application is required to include a statement containing the name and 
address of the contract research organization, identifying the clinical 
study, and listing the obligations transferred. If all obligations 
governing the conduct of the study have been transferred, a general 
statement of this transfer--in lieu of a listing of the specific 
obligations transferred--may be submitted.
    (ix) If original subject records were audited or reviewed by the 
sponsor in the course of monitoring any clinical study to verify the 
accuracy of the case reports submitted to the sponsor, a list 
identifying each clinical study so audited or reviewed.
    (9) Veterinary feed directive. Three copies of a veterinary feed 
directive (VFD) must be submitted in a form that accounts for the 
information described under Sec. 558.6(b)(3) and 558.6(b)(4) of this 
chapter.
    (10) Supplemental applications. If it is a supplemental application, 
full information shall be submitted on each proposed change concerning 
any statement made in the approved application.
    (11) Applicant's commitment. It is understood that the labeling and 
advertising for the new animal drug will prescribe, recommend, or 
suggest its use only under the conditions stated in the labeling which 
is part of this application and if the article is a prescription new 
animal drug, it is understood that any labeling which furnishes or 
purports to furnish information for use or which prescribes, recommends, 
or suggests a dosage for use of the new animal drug will also contain, 
in the same language and emphasis, information for its use including 
indications, effects, dosages, routes, methods, and frequency and 
duration of administration, any relevant hazards, contraindications, 
side effects, and precautions contained in the labeling which is part of 
this application. It is understood that all representations in this 
application apply to the drug produced until changes are made in 
conformity with Sec. 514.8.
    (12) Additional commitments. (i) New animal drugs as defined in 
Sec. 510.3 of this chapter, intended for use in the manufacture of 
animal feeds in any State will be shipped only to persons who may 
receive such drugs in accordance with Sec. 510.7 of this chapter.
    (ii) The methods, facilities, and controls described under item 5 of 
this application conform to the current good manufacturing practice 
regulations in subchapter C of this chapter.
    (iii) With respect to each nonclinical laboratory study contained in 
the application, either a statement that the study was conducted in 
compliance with the good laboratory practice regulations set forth in 
part 58 of this chapter, or, if the study was not conducted in 
compliance with such regulations, a

[[Page 94]]

brief statement of the reason for the noncompliance.
    (13) [Reserved]
    (14) Environmental assessment. The applicant is required to submit 
either a claim for categorical exclusion under Sec. 25.30 or Sec. 
25.33 of this chapter or an environmental assessment under Sec. 25.40 
of this chapter.
    (15) Assembling and binding the application. Assemble and bind an 
original and two copies of the application as follows:
    (i) Bind the original or ribbon copy of the application as copy No. 
1.
    (ii) Bind two identical copies as copy No. 2 and copy No. 3.
    (iii) Identify each front cover with the name of the applicant, new 
animal drug, and the copy number.
    (iv) Number each page of the application sequentially in the upper 
right hand corner or in another location so that the page numbers remain 
legible after the application has been bound, and organize the 
application consistent with paragraphs (b) (1) through (14) of this 
section. Each copy should bear the same page numbering, whether 
sequential in each volume or continuous and sequential throughout the 
application.
    (v) Include complete labeling in each of the copies. It is suggested 
that labeling be identified by date of printing or date of preparation.
    (vi) Submit separate applications for each different dosage form of 
the drug proposed. Repeating basic information pertinent to all dosage 
forms in each application is unnecessary if reference is made to the 
application containing such information. Include in each application 
information applicable to the specific dosage form, such as labeling, 
composition, stability data, and method of manufacture.
    (vii) Submit in folders amendments, supplements, and other 
correspondence sent after submission of an original application. The 
front cover of these submissions should be identified with the name of 
the applicant, new animal drug, copy number, and the new animal drug 
application number, if known.
    (c) When a new animal drug application is submitted for a new animal 
drug which has a stimulant, depressant, or hallucinogenic effect on the 
central nervous system, if it appears that the drug has a potential for 
abuse, the Commissioner shall forward that information to the Attorney 
General of the United States.

[40 FR 13825, Mar. 27, 1975]

    Editorial Note: For Federal Register citations affecting Sec. 
514.1, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and at www.govinfo.gov.



Sec. 514.3  Definitions.

    The definition and interpretation of terms contained in this section 
apply to those terms as used throughout subchapter E.
    Adverse drug experience is any adverse event associated with the use 
of a new animal drug, whether or not considered to be drug related, and 
whether or not the new animal drug was used in accordance with the 
approved labeling (i.e., used according to label directions or used in 
an extralabel manner, including but not limited to different route of 
administration, different species, different indications, or other than 
labeled dosage). Adverse drug experience includes, but is not limited 
to:
    (1) An adverse event occurring in animals in the course of the use 
of an animal drug product by a veterinarian or by a livestock producer 
or other animal owner or caretaker.
    (2) Failure of a new animal drug to produce its expected 
pharmacological or clinical effect (lack of expected effectiveness).
    (3) An adverse event occurring in humans from exposure during 
manufacture, testing, handling, or use of a new animal drug.
    ANADA is an abbreviated new animal drug application including all 
amendments and supplements.
    Applicant is a person or entity who owns or holds on behalf of the 
owner the approval for an NADA or an ANADA, and is responsible for 
compliance with applicable provisions of the act and regulations.
    Increased frequency of adverse drug experience is an increased rate 
of occurrence of a particular serious adverse drug event, expected or 
unexpected, after appropriate adjustment for drug exposure.

[[Page 95]]

    NADA is a new animal drug application including all amendments and 
supplements.
    Nonapplicant is any person other than the applicant whose name 
appears on the label and who is engaged in manufacturing, packing, 
distribution, or labeling of the product.
    Potential applicant means any person:
    (1) Intending to investigate a new animal drug under section 512(j) 
of the Federal Food, Drug, and Cosmetic Act (the act),
    (2) Investigating a new animal drug under section 512(j) of the act,
    (3) Intending to file a new animal drug application (NADA) or 
supplemental NADA under section 512(b)(1) of the act, or
    (4) Intending to file an abbreviated new animal drug application 
(ANADA) under section 512(b)(2) of the act.
    Presubmission conference means one or more conferences between a 
potential applicant and FDA to reach a binding agreement establishing a 
submission or investigational requirement.
    Presubmission conference agreement means that section of the 
memorandum of conference headed ``Presubmission Conference Agreement'' 
that records any agreement on the submission or investigational 
requirement reached by a potential applicant and FDA during the 
presubmission conference.
    Product defect/manufacturing defect is the deviation of a 
distributed product from the standards specified in the approved 
application, or any significant chemical, physical, or other change, or 
deterioration in the distributed drug product, including any microbial 
or chemical contamination. A manufacturing defect is a product defect 
caused or aggravated by a manufacturing or related process. A 
manufacturing defect may occur from a single event or from deficiencies 
inherent to the manufacturing process. These defects are generally 
associated with product contamination, product deterioration, 
manufacturing error, defective packaging, damage from disaster, or 
labeling error. For example, a labeling error may include any incident 
that causes a distributed product to be mistaken for, or its labeling 
applied to, another product.
    Serious adverse drug experience is an adverse event that is fatal, 
or life-threatening, or requires professional intervention, or causes an 
abortion, or stillbirth, or infertility, or congenital anomaly, or 
prolonged or permanent disability, or disfigurement.
    Unexpected adverse drug experience is an adverse event that is not 
listed in the current labeling for the new animal drug and includes any 
event that may be symptomatically and pathophysiologically related to an 
event listed on the labeling, but differs from the event because of 
greater severity or specificity. For example, under this definition 
hepatic necrosis would be unexpected if the labeling referred only to 
elevated hepatic enzymes or hepatitis.

[68 FR 15365, Mar. 31, 2003, as amended at 69 FR 51170, Aug. 18, 2004]



Sec. 514.4  Substantial evidence.

    (a) Definition of substantial evidence. Substantial evidence means 
evidence consisting of one or more adequate and well-controlled studies, 
such as a study in a target species, study in laboratory animals, field 
study, bioequivalence study, or an in vitro study, on the basis of which 
it could fairly and reasonably be concluded by experts qualified by 
scientific training and experience to evaluate the effectiveness of the 
new animal drug involved that the new animal drug will have the effect 
it purports or is represented to have under the conditions of use 
prescribed, recommended, or suggested in the labeling or proposed 
labeling thereof. Substantial evidence shall include such adequate and 
well-controlled studies that are, as a matter of sound scientific 
judgment, necessary to establish that a new animal drug will have its 
intended effect.
    (b) Characteristics of substantial evidence--(1) Qualifications of 
experts. Any study that is intended to be part of substantial evidence 
of the effectiveness of a new animal drug shall be conducted by experts 
qualified by scientific training and experience.
    (2) Intended uses and conditions of use. Substantial evidence of 
effectiveness of a new animal drug shall demonstrate that the new animal 
drug is effective for each intended use and associated

[[Page 96]]

conditions of use for and under which approval is sought.
    (i) Dose range labeling. Sponsors should, to the extent possible, 
provide for a dose range because it increases the utility of the new 
animal drug by providing the user flexibility in the selection of a safe 
and effective dose. In general, substantial evidence to support dose 
range labeling for a new animal drug intended for use in the diagnosis, 
cure, mitigation, treatment, or prevention of disease must consist of at 
least one adequate and well-controlled study on the basis of which 
qualified experts could fairly and reasonably conclude that the new 
animal drug will be effective for the intended use at the lowest dose of 
the dose range suggested in the proposed labeling for that intended use. 
Substantial evidence to support dose range labeling for a new animal 
drug intended to affect the structure or function of the body of an 
animal generally must consist of at least one adequate and well-
controlled study on the basis of which qualified experts could fairly 
and reasonably conclude that the new animal drug will be effective for 
the intended use at all doses within the range suggested in the proposed 
labeling for the intended use.
    (ii) [Reserved]
    (3) Studies--(i) Number. Substantial evidence of the effectiveness 
of a new animal drug for each intended use and associated conditions of 
use shall consist of a sufficient number of current adequate and well-
controlled studies of sufficient quality and persuasiveness to permit 
qualified experts:
    (A) To determine that the parameters selected for measurement and 
the measured responses reliably reflect the effectiveness of the new 
animal drug;
    (B) To determine that the results obtained are likely to be 
repeatable, and that valid inferences can be drawn to the target animal 
population; and
    (C) To conclude that the new animal drug is effective for the 
intended use at the dose or dose range and associated conditions of use 
prescribed, recommended, or suggested in the proposed labeling.
    (ii) Types. Adequate and well-controlled studies that are intended 
to provide substantial evidence of the effectiveness of a new animal 
drug may include, but are not limited to, published studies, foreign 
studies, studies using models, and studies conducted by or on behalf of 
the sponsor. Studies using models shall be validated to establish an 
adequate relationship of parameters measured and effects observed in the 
model with one or more significant effects of treatment.
    (c) Substantial evidence for combination new animal drugs--(1) 
Definitions. The following definitions of terms apply to this section:
    (i) Combination new animal drug means a new animal drug that 
contains more than one active ingredient or animal drug that is applied 
or administered simultaneously in a single dosage form or simultaneously 
in or on animal feed or drinking water.
    (ii) Dosage form combination new animal drug means a combination new 
animal drug intended for use other than in animal feed or drinking 
water.
    (iii) Antibacterial with respect to a particular target animal 
species means an active ingredient or animal drug: That is approved in 
that species for the diagnosis, cure, mitigation, treatment, or 
prevention of bacterial disease; or that is approved for use in that 
species for any other use that is attributable to its antibacterial 
properties. But, antibacterial does not include ionophores or arsenicals 
intended for use in combination in animal feed or drinking water.
    (iv) Appropriate concurrent use exists when there is credible 
evidence that the conditions for which the combination new animal drug 
is intended can occur simultaneously.
    (2) Combination new animal drugs that contain only active 
ingredients or animal drugs that have previously been separately 
approved. (i) For dosage form combination new animal drugs, except for 
those that contain a nontopical antibacterial, that contain only active 
ingredients or animal drugs that have previously been separately 
approved for the particular uses and conditions of use for which they 
are intended in combination, a sponsor shall demonstrate:
    (A) By substantial evidence, as defined in this section, that any 
active ingredient or animal drug intended only for the same use as 
another active

[[Page 97]]

ingredient or animal drug in the combination makes a contribution to the 
effectiveness of the combination new animal drug;
    (B) That each active ingredient or animal drug intended for at least 
one use that is different from all the other active ingredients or 
animal drugs used in the combination provides appropriate concurrent use 
for the intended target animal population; and
    (C) That the active ingredients or animal drugs are physically 
compatible and do not have disparate dosing regimens if FDA, based on 
scientific information, has reason to believe the active ingredients or 
animal drugs are physically incompatible or have disparate dosing 
regimens.
    (ii) For combination new animal drugs intended for use in animal 
feed or drinking water that contain only active ingredients or animal 
drugs that have previously been separately approved for the particular 
uses and conditions of use for which they are intended in combination, 
the sponsor shall demonstrate:
    (A) By substantial evidence, as defined in this section, that any 
active ingredient or animal drug intended only for the same use as 
another active ingredient or animal drug in the combination makes a 
contribution to the effectiveness of the combination new animal drug;
    (B) For such combination new animal drugs that contain more than one 
antibacterial ingredient or animal drug, by substantial evidence, as 
defined in this section, that each antibacterial makes a contribution to 
labeled effectiveness;
    (C) That each active ingredient or animal drug intended for at least 
one use that is different from all other active ingredients or animal 
drugs used in the combination provides appropriate concurrent use for 
the intended target animal population; and
    (D) That the active ingredients or animal drugs intended for use in 
drinking water are physically compatible if FDA, based on scientific 
information, has reason to believe the active ingredients or animal 
drugs are physically incompatible.
    (3) Other combination new animal drugs. For all other combination 
new animal drugs, the sponsor shall demonstrate by substantial evidence, 
as defined in this section, that the combination new animal drug will 
have the effect it purports or is represented to have under the 
conditions of use prescribed, recommended, or suggested in the proposed 
labeling and that each active ingredient or animal drug contributes to 
the effectiveness of the combination new animal drug.

[64 FR 40756, July 28, 1999]



Sec. 514.5  Presubmission conferences.

    (a) General principle underlying the conduct of a presubmission 
conference. The general principle underlying the conduct of any 
presubmission conference is that there should be candid, full, and open 
communication.
    (b) Requesting a presubmission conference. A potential applicant is 
entitled to one or more conferences prior to the submission of an NADA, 
supplemental NADA, or an ANADA to reach an agreement establishing part 
or all of a submission or investigational requirement. A potential 
applicant's request for a presubmission conference must be submitted to 
FDA in a signed letter. The letter must include a proposed agenda that 
clearly outlines the scope, purpose, and objectives of the presubmission 
conference and must list the names and positions of the representatives 
who are expected to attend the presubmission conference on behalf of the 
applicant.
    (c) Timing. A potential applicant may request one or more 
presubmission conferences at any time prior to the filing of a NADA, 
supplemental NADA, or an ANADA. A request for a presubmission conference 
must be received by FDA at least 30 calendar days in advance of the 
requested conference date. FDA will schedule the presubmission 
conference at a time agreeable to both FDA and the potential applicant.
    (d) Advance information. The potential applicant must provide to 
FDA, at least 30 calendar days before a scheduled presubmission 
conference, a detailed agenda, a copy of any materials to be presented 
at the conference, a list of proposed indications and, if available, a 
copy of the proposed labeling for the product under consideration, and 
copies of materials evaluated or referenced relative to issues listed in

[[Page 98]]

the agenda for the conference. If the materials are not provided or are 
not sufficient to provide the basis for meaningful discussion, FDA may 
elect to postpone part or all of the meeting until sufficient materials 
are provided to FDA.
    (e) Conduct of a presubmission conference. The potential applicant 
and FDA may each bring consultants to the presubmission conference. The 
presubmission conference(s) will be directed primarily at establishing 
agreement between FDA and the potential applicant regarding a submission 
or investigational requirement. The submission or investigational 
requirement may include, among other things, the number, types, and 
general design of studies that are necessary to demonstrate the safety 
and effectiveness of a new animal drug for the intended uses and 
conditions of use prescribed, recommended, or suggested in the proposed 
labeling for the new animal drug.
    (f) Documentation of a presubmission conference--(1) Memorandum of 
conference--(i) Preparation. FDA will prepare a memorandum for each 
presubmission conference that will include, among other things, any 
background pertinent to the request for meeting; a summary of the key 
points of discussion; agreements; and action items and assignments of 
responsibility. That portion of the memorandum of conference that 
documents any agreements reached regarding all or part of a submission 
or investigational requirement will be included under the heading 
``Presubmission Conference Agreement.'' If the presubmission conference 
agreement section of the memorandum is silent on an issue, including one 
that was discussed in the conference or addressed by materials provided 
for the conference, such silence does not constitute agreement between 
FDA and the potential applicant on the issue.
    (ii) Sending a copy to the potential applicant. FDA will send a copy 
of the memorandum to the potential applicant for review no later than 45 
calendar days after the date of the conference
    (iii) Requests for changes or clarification. If a potential 
applicant requests changes to, or clarification of, the substance of the 
memorandum, the request must be sent to FDA within 30 calendar days from 
the date a copy of the memorandum is sent to the applicant. If the 
potential applicant requests changes or clarification, FDA will send the 
potential applicant a response to their request no later than 45 
calendar days after the date of receipt of the request.
    (iv) Administrative record. A copy of FDA's original memorandum of 
conference and, as appropriate, a copy of an amended memorandum to 
correct or clarify the content of the original memorandum will be made 
part of the administrative file.
    (2) Field studies. If FDA requires more than one field study to 
establish by substantial evidence that the new animal drug is effective 
for its intended uses under the conditions of use prescribed, 
recommended, or suggested in the proposed labeling, FDA will provide 
written scientific justification for requiring more than one field 
study. Such justification must be provided no later than 25 calendar 
days after the date of the conference at which the requirement for more 
than one field study is established. If FDA does not believe more than 
one field study is required but the potential applicant voluntarily 
proposes to conduct more than one field study, FDA will not provide such 
written justification. If FDA requires one field study to be conducted 
at multiple locations, FDA will provide justification for requiring 
multiple locations verbally during the presubmission conference and in 
writing as part of the memorandum of conference.
    (g) Modification of presubmission conference agreements. An 
agreement made under a presubmission conference requested under section 
512(b)(3) of the act and documented in a memorandum of conference is 
binding on the potential applicant and FDA and may only be modified if:
    (1) FDA and the potential applicant mutually agree to modify, in 
part or in whole, the agreement and such modification is documented and 
provided to the potential applicant as described in paragraph (f)(1) of 
this section; or

[[Page 99]]

    (2) FDA by written order determines that a substantiated scientific 
requirement essential to the determination of safety or effectiveness of 
the new animal drug appeared after the conference.
    (h) When the terms of a presubmission conference agreement are not 
valid. (1) A presubmission conference agreement will no longer be valid 
if:
    (i) The potential applicant makes to FDA, before, during, or after 
the presubmission conference, any untrue statement of material fact; or
    (ii) The potential applicant fails to follow any material term of 
the agreement; and
    (2) A presubmission conference may no longer be valid if the 
potential applicant submits false or misleading data relating to a new 
animal drug to FDA.
    (i) Dispute resolution. FDA is committed to resolving differences 
between a potential applicant and FDA reviewing divisions with respect 
to requirements for the investigation of new animal drugs and for NADAs, 
supplemental NADAs, and ANADAs as quickly and amicably as possible 
through a cooperative exchange of information and views. When 
administrative or procedural disputes arise, a potential applicant 
should first attempt to resolve the matter within the appropriate review 
division beginning with the individual(s) most directly assigned to the 
review of the application or investigational exemption. If the dispute 
cannot be resolved after such attempts, the dispute shall be evaluated 
and administered in accordance with applicable regulations (21 CFR 
10.75). Dispute resolution procedures may be further explained by 
guidance available from the Center for Veterinary Medicine.

[69 FR 51170, Aug. 18, 2004]



Sec. 514.6  Amended applications.

    The applicant may submit an amendment to an application that is 
pending, including changes that may alter the conditions of use, the 
labeling, safety, effectiveness, identity, strength, quality, or purity 
of the drug or the adequacy of the manufacturing methods, facilities, 
and controls to preserve them, in which case the unamended application 
may be considered as withdrawn and the amended application may be 
considered resubmitted on the date on which the amendment is received by 
the Food and Drug Administration. The applicant will be notified of such 
date.



Sec. 514.7  Withdrawal of applications without prejudice.

    The sponsor may withdraw his pending application from consideration 
as a new animal drug application upon written notification to the Food 
and Drug Administration. Such withdrawal may be made without prejudice 
to a future filing. Upon resubmission, the time limitation will begin to 
run from the date the resubmission is received by the Food and Drug 
Administration. The original application will be retained by the Food 
and Drug Administration although it is considered withdrawn. The 
applicant shall be furnished a copy at cost on request.



Sec. 514.8  Supplements and other changes to an approved application.

    (a) Definitions. (1) The definitions and interpretations contained 
in section 201 of the Federal Food, Drug, and Cosmetic Act (the act) 
apply to those terms when used in this part.
    (2) The following definitions of terms apply to this part:
    (i) Assess the effects of the change means to evaluate the effects 
of a manufacturing change on the identity, strength, quality, purity, 
and potency of a drug as these factors may relate to the safety or 
effectiveness of the drug.
    (ii) Drug substance means an active ingredient as defined under 
Sec. 210.3(b)(7) of this chapter.
    (iii) Minor changes and stability report (MCSR) means an annual 
report that is submitted to the application once each year within 60 
days before or after the anniversary date of the application's original 
approval or on a mutually agreed upon date. The report must include 
minor manufacturing and control changes made according to Sec. 
514.8(b)(4) or state that no changes were made; and stability data 
generated on commercial or production batches according to an approved 
stability protocol or commitment.

[[Page 100]]

    (iv) Specification means the quality standard (i.e., tests, 
analytical procedures, and acceptance criteria) provided in an approved 
application to confirm the quality of drugs including, for example, drug 
substances, Type A medicated articles, drug products, intermediates, raw 
materials, reagents, components, in-process materials, container closure 
systems, and other materials used in the production of a drug. For the 
purpose of this definition, the term ``acceptance criteria'' means 
numerical limits, ranges, or other criteria for the tests described.
    (b) Manufacturing changes to an approved application--(1) General 
provisions. (i) The applicant must notify FDA about each change in each 
condition established in an approved application beyond the variations 
already provided for in the application. The notice is required to 
describe the change fully. Depending on the type of change, the 
applicant must notify FDA about it in a supplement under paragraph 
(b)(2) or (b)(3) of this section or by inclusion of the information in 
the annual report to the application under paragraph (b)(4) of this 
section.
    (ii) The holder of an approved application under section 512 of the 
act must assess the effects of the change before distributing a drug 
made with a manufacturing change.
    (iii) Notwithstanding the requirements of paragraphs (b)(2) and 
(b)(3) of this section, an applicant must make a change provided for in 
those paragraphs in accordance with a regulation or guidance that 
provides for a less burdensome notification of the change (for example, 
by submission of a supplement that does not require approval prior to 
distribution of the drug, or by notification in the next annual report 
described in paragraph (b)(4) of this section).
    (iv) In each supplement and amendment to a supplement providing for 
a change under paragraph (b)(2) or (b)(3) of this section, the applicant 
must include a statement certifying that a field copy has been provided 
to the appropriate FDA district office. No field copy is required for a 
supplement providing for a change made to a drug manufactured outside of 
the United States.
    (v) A supplement or annual report described in paragraph (b)(4) of 
this section must include a list of all changes contained in the 
supplement or annual report. For supplements, this list must be provided 
in the cover letter.
    (2) Changes requiring submission and approval of a supplement prior 
to distribution of the drug made using the change (major changes). (i) A 
supplement must be submitted for any change in the drug, production 
process, quality controls, equipment, or facilities that has a 
substantial potential to have an adverse effect on the identity, 
strength, quality, purity, or potency of the drug as these factors may 
relate to the safety or effectiveness of the drug.
    (ii) These changes include, but are not limited to:
    (A) Except those described in paragraphs (b)(3) and (b)(4) of this 
section, changes in the qualitative or quantitative formulation of the 
drug, including inactive ingredients, or in the specifications provided 
in the approved application;
    (B) Changes requiring completion of appropriate clinical studies to 
demonstrate the equivalence of the drug to the drug as manufactured 
without the change;
    (C) Changes that may affect drug substance or drug product sterility 
assurance, such as changes in drug substance, drug product or component 
sterilization method(s) or an addition, deletion, or substitution of 
steps in an aseptic processing operation;
    (D) Changes in the synthesis or manufacture of the drug substance 
that may affect the impurity profile and/or the physical, chemical, or 
biological properties of the drug substance;
    (E) Changes in a drug product container closure system that controls 
the drug delivered to the animal or changes in the type or composition 
of a packaging component that may affect the impurity profile of the 
drug product;
    (F) Changes solely affecting a natural product, a recombinant DNA-
derived protein/polypeptide, or a complex or conjugate of a drug 
substance with a monoclonal antibody for the following:
    (1) Changes in the virus or adventitious agent removal or 
inactivation method(s),

[[Page 101]]

    (2) Changes in the source material or cell line, and
    (3) Establishment of a new master cell bank or seed;
    (G) Changes to a drug under an application that is subject to a 
validity assessment because of significant questions regarding the 
integrity of the data supporting that application.
    (iii) The applicant must obtain approval of a supplement from FDA 
prior to distribution of a drug made using a change under paragraph 
(b)(2) of this section. The supplement must be labeled ``Prior Approval 
Supplement.'' Except for submissions under paragraph (b)(2)(v) of this 
section, the following information must be contained in the supplement:
    (A) A completed Form FDA 356V;
    (B) A detailed description of the proposed change;
    (C) The drug(s) involved;
    (D) The manufacturing site(s) or area(s) affected;
    (E) A description of the methods used and studies performed to 
assess the effects of the change;
    (F) The data derived from such studies;
    (G) Appropriate documentation (for example, updated master batch 
records, specification sheets) including previously approved 
documentation (with the changes highlighted) or references to previously 
approved documentation;
    (H) For a natural product, a recombinant DNA-derived protein/
polypeptide, or a complex or conjugate of a drug substance with a 
monoclonal antibody, relevant validation protocols and standard 
operating procedures must be provided in addition to the requirements in 
paragraphs (b)(2)(iii)(E) and (b)(2)(iii)(F) of this section;
    (I) For sterilization process and test methodologies related to 
sterilization process validation, relevant validation protocols and a 
list of relevant standard operating procedures must be provided in 
addition to the requirements in paragraphs (b)(2)(iii)(E) and 
(b)(2)(iii)(F) of this section; and
    (J) Any other information as directed by FDA.
    (iv) An applicant may ask FDA to expedite its review of a supplement 
for public health reasons or if a delay in making the change described 
in it would impose an extraordinary hardship on the applicant. Such a 
supplement and its mailing cover must be plainly marked: ``Prior 
Approval Supplement-Expedited Review Requested.''
    (v) Comparability Protocols. An applicant may submit one or more 
protocols describing the specific tests and studies and acceptance 
criteria to be achieved to demonstrate the lack of adverse effect for 
specified types of manufacturing changes on the identity, strength, 
quality, purity, and potency of the drug as these factors may relate to 
the safety or effectiveness of the drug. Any such protocols, if not 
included in the approved application, or changes to an approved 
protocol, must be submitted as a supplement requiring approval from FDA 
prior to distribution of the drug produced with the manufacturing 
change. The supplement, if approved, may subsequently justify a reduced 
reporting category for the particular change because the use of the 
protocol for that type of change reduces the potential risk of an 
adverse effect. A comparability protocol supplement must be labeled 
``Prior Approval Supplement--Comparability Protocol.''
    (3) Changes requiring submission of a supplement at least 30 days 
prior to distribution of the drug made using the change (moderate 
changes). (i) A supplement must be submitted for any change in the drug, 
production process, quality controls, equipment, or facilities that has 
a moderate potential to have an adverse effect on the identity, 
strength, quality, purity, or potency of the drug as these factors may 
relate to the safety or effectiveness of the drug.
    (ii) These changes include, but are not limited to:
    (A) A change in the container closure system that does not affect 
the quality of the drug except as otherwise described in paragraphs 
(b)(2) and (b)(4) of this section;
    (B) Changes solely affecting a natural protein, a recombinant DNA-
derived protein/polypeptide or a complex or conjugate of a drug 
substance with a monoclonal antibody, including:
    (1) An increase or decrease in production scale during finishing 
steps that involves different equipment, and

[[Page 102]]

    (2) Replacement of equipment with that of a different design that 
does not affect the process methodology or process operating parameters.
    (C) Relaxation of an acceptance criterion or deletion of a test to 
comply with an official compendium that is consistent with FDA statutory 
and regulatory requirements.
    (iii) A supplement submitted under paragraph (b)(3)(i) or (b)(3)(vi) 
of this section is required to give a full explanation of the basis for 
the change and identify the date on which the change is made. The 
supplement submitted under paragraph (b)(3)(i) must be labeled 
``Supplement-Changes Being Effected in 30 Days.''
    (iv) Pending approval of the supplement by FDA and except as 
provided in paragraph (b)(3)(vi) of this section, distribution of the 
drug made using the change may begin not less than 30 days after receipt 
of the supplement by FDA. The information listed in paragraphs 
(b)(2)(iii)(A) through (b)(2)(iii)(J) of this section must be contained 
in the supplement.
    (v) The applicant must not distribute the drug made using the change 
if within 30 days following FDA's receipt of the supplement, FDA informs 
the applicant that either:
    (A) The change requires approval prior to distribution of the drug 
in accordance with paragraph (b)(2) of this section; or
    (B) Any of the information required under paragraph (b)(3)(iv) of 
this section is missing. In this case, the applicant must not distribute 
the drug made using the change until the supplement has been amended to 
provide the missing information.
    (vi) The agency may designate a category of changes for the purpose 
of providing that, in the case of a change in such category, the holder 
of an approved application may commence distribution of the drug 
involved upon receipt by the agency of a supplement for the change. The 
information listed in paragraphs (b)(2)(iii)(A) through (b)(2)(iii)(J) 
of this section must be contained in the supplement. The supplement must 
be labeled ``Supplement-Changes Being Effected.'' These changes include, 
but are not limited to:
    (A) Addition to a specification or changes in the methods or 
controls to provide increased assurance that the drug will have the 
characteristics of identity, strength, quality, purity, or potency that 
it purports or is represented to possess; and
    (B) A change in the size and/or shape of a container for a 
nonsterile drug product, except for solid dosage forms, without a change 
in the labeled amount of drug product or from one container closure 
system to another.
    (vii) If the agency disapproves the supplemental application, it may 
order the manufacturer to cease distribution of the drug(s) made with 
the manufacturing change.
    (4) Changes and updated stability data to be described and submitted 
in an annual report (minor changes). (i) Changes in the drug, production 
process, quality controls, equipment, or facilities that have a minimal 
potential to have an adverse effect on the identity, strength, quality, 
purity, or potency of the drug as these factors may relate to the safety 
or effectiveness of the drug must be documented by the applicant in an 
annual report to the application as described under paragraph 
(a)(2)(iii) of this section. The report must be labeled ``Minor Changes 
and Stability Report.''
    (ii) These changes include but are not limited to:
    (A) Any change made to comply with a change to an official 
compendium, except a change in paragraph (b)(3)(ii)(C) of this section, 
that is consistent with FDA statutory and regulatory requirements;
    (B) The deletion or reduction of an ingredient intended to affect 
only the color of the drug product;
    (C) Replacement of equipment with that of the same design and 
operating principles except for those equipment changes described in 
paragraph (b)(3)(ii)(B)(2) of this section;
    (D) A change in the size and/or shape of a container containing the 
same number of dosage units for a nonsterile solid dosage form drug 
product, without a change from one container closure system to another;
    (E) A change within the container closure system for a nonsterile 
drug product, based upon a showing of

[[Page 103]]

equivalency to the approved system under a protocol approved in the 
application or published in an official compendium;
    (F) An extension of an expiration dating period based upon full 
shelf-life data on production batches obtained from a protocol approved 
in the application;
    (G) The addition or revision of an alternative analytical procedure 
that provides the same or increased assurance of the identity, strength, 
quality, purity, or potency of the drug being tested as the analytical 
procedure described in the approved application, or deletion of an 
alternative analytical procedure; and
    (H) The addition by embossing, debossing, or engraving of a code 
imprint to a solid oral dosage form drug product other than a modified 
release dosage form, or a minor change in an existing code imprint.
    (iii) For changes under this category, the applicant is required to 
submit in the annual report:
    (A) A completed Form FDA 356V;
    (B) A statement by the holder of the approved application that the 
effects of the change have been assessed;
    (C) A detailed description of the change(s);
    (D) The manufacturing site(s) or area(s) involved;
    (E) The date each change was implemented;
    (F) Data from studies and tests performed to assess the effects of 
the change;
    (G) For a natural product, recombinant DNA-derived protein/
polypeptide, complex or conjugate of a drug substance with a monoclonal 
antibody, sterilization process or test methodology related to 
sterilization process validation, relevant validation protocols and/or 
standard operating procedures;
    (H) Appropriate documentation (for example, updated master batch 
records, specification sheets, etc.) including previously approved 
documentation (with the changes highlighted) or references to previously 
approved documentation;
    (I) Updated stability data generated on commercial or production 
batches according to an approved stability protocol or commitment; and
    (J) Any other information as directed by FDA.
    (c) Labeling and other changes to an approved application--(1) 
General provisions. The applicant must notify FDA about each change in 
each condition established in an approved application beyond the 
variations already provided for in the application. The notice is 
required to describe the change fully.
    (2) Labeling changes requiring the submission and approval of a 
supplement prior to distribution of the drug made using the change 
(major changes). (i) Addition of intended uses and changes to package 
labeling require a supplement. These changes include, but are not 
limited to:
    (A) Revision in labeling, such as updating information pertaining to 
effects, dosages, adverse reactions, contraindications, which includes 
information headed ``adverse reactions,'' ``warnings,'' ``precautions,'' 
and ``contraindications,'' except ones described in (c)(3) of this 
section;
    (B) Addition of an intended use;
    (C) If it is a prescription drug, any mailing or promotional piece 
used after the drug is placed on the market is labeling requiring a 
supplemental application, unless:
    (1) The parts of the labeling furnishing directions, warnings, and 
information for use of the drug are the same in language and emphasis as 
labeling approved or permitted; and
    (2) Any other parts of the labeling are consistent with and not 
contrary to such approved or permitted labeling.
    (3) Prescription drug labeling not requiring an approved 
supplemental application is submitted in accordance with Sec. 
514.80(b)(5)(ii).
    (D) Any other changes in labeling, except ones described in 
paragraph (c)(3) of this section.
    (ii) The applicant must obtain approval of the supplement from FDA 
prior to distribution of the drug. The supplement must contain the 
following:
    (A) A completed Form FDA 356V;
    (B) A detailed description of the proposed change;
    (C) The drug(s) involved;

[[Page 104]]

    (D) The data derived from studies in support of the change; and
    (E) Any other information as directed by FDA.
    (3) Labeling changes to be placed into effect prior to receipt of a 
written notice of approval of a supplemental application. (i) Labeling 
changes of the following kinds that increase the assurance of drug 
safety proposed in supplemental applications must be placed into effect 
immediately:
    (A) The addition to package labeling, promotional labeling, or 
prescription drug advertising of additional warning, contraindication, 
adverse reaction, and precaution information;
    (B) The deletion from package labeling, promotional labeling, or 
drug advertising of false, misleading, or unsupported intended uses or 
claims for effectiveness; and
    (C) Any other changes as directed by FDA.
    (ii) Labeling changes (for example, design and style) that do not 
decrease safety of drug use proposed in supplemental applications may be 
placed into effect prior to written notice of approval from FDA of a 
supplemental application.
    (iii) A supplement submitted under paragraph (c)(3) of this section 
must include the following information:
    (A) A full explanation of the basis for the changes, the date on 
which such changes are being effected, and plainly marked on the mailing 
cover and on the supplement, ``Supplement--Labeling Changes Being 
Effected'';
    (B) Two sets of printed copies of any revised labeling to be placed 
in use, identified with the new animal drug application number; and
    (C) A statement by the applicant that all promotional labeling and 
all drug advertising will promptly be revised consistent with the 
changes made in the labeling on or within the new animal drug package no 
later than upon approval of the supplemental application.
    (iv) If the supplemental application is not approved and the drug is 
being distributed with the proposed labeling, FDA may initiate an 
enforcement action because the drug is misbranded under section 502 of 
the act and/or adulterated under section 501 of the act. In addition, 
under section 512(e) of the act, FDA may, after due notice and 
opportunity for a hearing, issue an order withdrawing approval of the 
application.
    (4) Changes providing for additional distributors to be reported 
under Records and reports concerning experience with approved new animal 
drugs (Sec. 514.80). Supplemental applications as described under 
paragraph (c)(2) of this section will not be required for an additional 
distributor to distribute a drug that is the subject of an approved new 
animal drug application or abbreviated new animal drug application if 
the conditions described under Sec. 514.80(b)(5)(iii) are met.
    (d) Patent information. The applicant must comply with the patent 
information requirements under section 512(c)(3) of the act.
    (e) Claimed exclusivity. If an applicant claims exclusivity under 
section 512(c)(2)(F) of the act upon approval of a supplemental 
application for a change in its previously approved drug, the applicant 
must include such a statement.
    (f) Good laboratory practice for nonclinical laboratory studies. A 
supplemental application that contains nonclinical laboratory studies 
must include, with respect to each nonclinical study, either a statement 
that the study was conducted in compliance with the requirements set 
forth in part 58 of this chapter, or, if the study was not conducted in 
compliance with such regulations, a brief statement of the reason for 
the noncompliance.

[71 FR 74782, Dec. 13, 2006]



Sec. 514.11  Confidentiality of data and information in a new animal
drug application file.

    (a) For purposes of this section the NADA file includes all data and 
information submitted with or incorporated by reference in the NADA, 
INAD's incorporated into the NADA, supplemental NADA's, reports under 
Sec. Sec. 514.80 and 510.301 of this chapter, master files, and other 
related submissions. The availability for public disclosure of any 
record in the NADA file shall be handled in accordance with the 
provisions of this section.

[[Page 105]]

    (b) The existence of an NADA file will not be disclosed by the Food 
and Drug Administration before the application has been approved, unless 
it has been previously disclosed or acknowledged.
    (c) If the existence of an NADA file has not been publicly disclosed 
or acknowledged, no data or information in the NADA file is available 
for public disclosure.
    (d) If the existence of an NADA file has been publicly disclosed or 
acknowledged before the application has been approved, no data or 
information contained in the file is available for public disclosure, 
but the Commissioner may, in his discretion, disclose a summary of such 
selected portions of the safety and effectiveness data as are 
appropriate for public consideration of a specific pending issue, i.e., 
at an open session of a Food and Drug Administration advisory committee 
or pursuant to an exchange of important regulatory information with a 
foreign government.
    (e) After an application has been approved, the following data and 
information in the NADA file are immediately available for public 
disclosure unless extraordinary circumstances are shown:
    (1) All safety and effectiveness data and information previously 
disclosed to the public, as defined in Sec. 20.81 of this chapter.
    (2) A summary or summaries of the safety and effectiveness data and 
information submitted with or incorporated by reference in the NADA 
file. Such summaries do not constitute the full reports of 
investigations under section 512(b)(1) of the act (21 U.S.C. 360b(b)(1)) 
on which the safety or effectiveness of the drug may be approved. Such 
summaries shall consist of the following:
    (i) For an NADA approved prior to July 1, 1975, internal agency 
records that describe such data and information, e.g., a summary of 
basis for approval or internal reviews of the data and information, 
after deletion of:
    (a) Names and any information that would identify the investigators.
    (b) Any inappropriate gratuitous comments unnecessary to an 
objective analysis of the data and information.
    (ii) For an NADA approved after July 1, 1975, a summary of such data 
and information prepared in one of the following two alternative ways 
shall be publicly released when the application is approved.
    (a) The Center for Veterinary Medicine may at an appropriate time 
prior to approval of the NADA require the applicant to prepare a summary 
of such data and information, which will be reviewed and, where 
appropriate, revised by the Center.
    (b) The Center for Veterinary Medicine may prepare its own summary 
of such data and information.
    (3) A protocol for a test or study, unless it is shown to fall 
within the exemption established for trade secrets and confidential 
commercial information in Sec. 20.61 of this chapter.
    (4) Adverse reaction reports, product experience reports, consumer 
complaints, and other similar data and information, after deletion of:
    (i) Names and any information that would identify the person using 
the product.
    (ii) Names and any information that would identify any third party 
involved with the report, such as a physician, hospital, or other 
institution.
    (5) A list of all active ingredients and any inactive ingredients 
previously disclosed to the public as defined in Sec. 20.81 of this 
chapter.
    (6) An assay method or other analytical method, unless it serves no 
regulatory or compliance purpose and is shown to fall within the 
exemption established in Sec. 20.61 of this chapter.
    (7) All correspondence and written summaries of oral discussions 
relating to the NADA, in accordance with the provisions of part 20 of 
this chapter.
    (f) All safety and effectiveness data and information not previously 
disclosed to the public are available for public disclosure at the time 
any one of the following events occurs unless extraordinary 
circumstances are known:
    (1) The NADA has been abandoned and no further work is being 
undertaken with respect to it.
    (2) A final determination is made that the NADA is not approvable, 
and all legal appeals have been exhausted.
    (3) Approval of the NADA is withdrawn, and all legal appeals have 
been exhausted.

[[Page 106]]

    (4) A final determination has been made that the animal drug is not 
a new animal drug.
    (5) A final determination has been made that the animal drug may be 
marketed without submission of such safety and/or effectiveness data and 
information.
    (g) The following data and information in an NADA file are not 
available for public disclosure unless they have been previously 
disclosed to the public as defined in Sec. 20.81 of this chapter or 
they relate to a product or ingredient that has been abandoned and they 
no longer represent a trade secret or confidential commercial or 
financial information as defined in Sec. 20.61 of this chapter:
    (1) Manufacturing methods or processes, including quality control 
procedures.
    (2) Production, sales, distribution, and similar data and 
information, except that any compilation of such data and information 
aggregated and prepared in a way that does not reveal data or 
information which is not available for public disclosure under this 
provision is available for public disclosure.
    (3) Quantitative or semiquantitative formulas.
    (h) For purposes of this regulation, safety and effectiveness data 
include all studies and tests of an animal drug on animals and all 
studies and tests on the animal drug for identity, stability, purity, 
potency, and bioavailability.

[40 FR 13825, Mar. 27, 1975, as amended at 42 FR 3109, Jan. 14, 1977; 42 
FR 15675, Mar. 22, 1977; 54 FR 18280, Apr. 28, 1989; 68 FR 15365, Mar. 
31, 2003; 79 FR 14611, Mar. 17, 2014]



Sec. 514.12  Confidentiality of data and information in an 
investigational new animal drug notice.

    (a) The existence of an INAD notice will not be disclosed by the 
Food and Drug Administration unless it has previously been publicly 
disclosed or acknowledged.
    (b) The availability for public disclosure of all data and 
information in an INAD file shall be handled in accordance with 
provisions established in Sec. 514.11.



Sec. 514.15  Untrue statements in applications.

    Among the reasons why an application for a new animal drug or animal 
feed bearing or containing a new animal drug may contain an untrue 
statement of a material fact are:
    (a) Differences in:
    (1) Conditions of use prescribed, recommended, or suggested by the 
applicant for the product from the conditions of such use stated in the 
application;
    (2) Articles used as components of the product from those listed in 
the application;
    (3) Composition of the product from that stated in the application;
    (4) Methods used in or the facilities and controls used for the 
manufacture, processing, or packing of the product from such methods, 
facilities, and controls described in the application;
    (5) Labeling from the specimens contained in the application; or
    (b) The unexplained omission in whole or in part from an application 
or from an amendment or supplement to an application or from any record 
or report required under the provisions of section 512 of the act and 
Sec. 514.80 or Sec. 510.301 of this chapter of any information 
obtained from:
    (1) Investigations as to the safety, effectiveness, identity, 
strength, quality, or purity of the drug, made by the applicant on the 
drug, or
    (2) Investigations or experience with the product that is the 
subject of the application, or any related product, available to the 
applicant from any source if such information is pertinent to an 
evaluation of the safety, effectiveness, identity, strength, quality, or 
purity of the drug, when such omission would bias an evaluation of the 
safety or effectiveness of the product.
    (c) Any nonclinical laboratory study contained in the application 
was not conducted in compliance with the good laboratory practice 
regulations as set forth in part 58 of this chapter, and the application 
fails to include a brief

[[Page 107]]

statement of the reason for the noncompliance.

[40 FR 13825, Mar. 27, 1975, as amended at 49 FR 7226, Feb. 28, 1984; 50 
FR 7517, Feb. 22, 1985; 68 FR 15365, Mar. 31, 2003]



            Subpart B_Administrative Actions on Applications



Sec. 514.80  Records and reports concerning experience with approved
new animal drugs.

    The following table outlines the purpose for each paragraph of this 
section:

------------------------------------------------------------------------
                 Purpose                    21 CFR Paragraph and Title
------------------------------------------------------------------------
What information must be reported         514.80(a) Applicability.
 concerning approved NADAs or ANADAs?
------------------------------------------------------------------------
What authority does FDA have for          514.80(a)(1).
 requesting records and reports?
Who is required to establish, maintain,
 and report required information
 relating to experiences with a new
 animal drug?
Is information from foreign sources
 required?
------------------------------------------------------------------------
What records must be established and      514.80(a)(2).
 maintained and what reports filed with
 FDA?
------------------------------------------------------------------------
What is FDA's purpose for requiring       514.80(a)(3).
 reports?
------------------------------------------------------------------------
Do applicants of Type A medicated         514.80(a)(4).
 articles have to establish, maintain,
 and report information required under
 Sec. 514.80?
------------------------------------------------------------------------
How do the requirements under Sec. 514.80(a)(5).
 514.80 relate to current good
 manufacturing practices?
------------------------------------------------------------------------
                                          514.80(b) Reporting
                                           requirements.
------------------------------------------------------------------------
What are the requirements for reporting   514.80(b)(1) Three-day NADA/
 product/manufacturing defects?            ANADA field alert report.
------------------------------------------------------------------------
                                          514.80(b)(2) Fifteen-day NADA/
                                           ANADA alert report.
------------------------------------------------------------------------
What are the requirements for reporting   514.80(b)(2)(i) Initial
 serious and unexpected adverse drug       report.
 experiences?
------------------------------------------------------------------------
What are the requirements for followup    514.80(b)(2)(ii) Followup
 reporting of serious and unexpected       report.
 adverse drug experiences?
------------------------------------------------------------------------
What are the requirements for             514.80(b)(3) Nonapplicant
 nonapplicants for reporting adverse       report.
 drug experiences?
------------------------------------------------------------------------
What are the general requirements for     514.80(b)(4) Periodic drug
 submission of periodic drug experience    experience report.
 reports, e.g., method of submission,
 submission date and frequency, when is
 it to be submitted, how many copies?
How do I petition to change the date of
 submission or frequency of submissions?
------------------------------------------------------------------------
What must be submitted in the periodic    514.80(b)(4)(i) through
 drug experience reports?                  (b)(4)(iv).
------------------------------------------------------------------------
What distribution data must be            514.80(b)(4)(i) Distribution
 submitted?                                data.
How should the distribution data be
 submitted?
------------------------------------------------------------------------
What labeling materials should be         514.80(b)(4)(ii) Labeling.
 submitted?
How do I report changes to the labeling
 materials since the last report?
------------------------------------------------------------------------
                                          514.80(b)(4)(iii) Nonclinical
                                           laboratory studies and
                                           clinical data not previously
                                           reported.
------------------------------------------------------------------------
What are the requirements for submission  514.80(b)(4)(iii)(A).
 of nonclinical laboratory studies?
------------------------------------------------------------------------
What are the requirements for submission  514.80(b)(4)(iii)(B).
 of clinical laboratory data?
------------------------------------------------------------------------
When must results of clinical trials      514.80(b)(4)(iii)(C).
 conducted by or for the applicant be
 reported?
------------------------------------------------------------------------

[[Page 108]]

 
                                          514.80(b)(4)(iv) Adverse drug
                                           experiences.
------------------------------------------------------------------------
How do I report product/manufacturing     514.80(b)(4)(iv)(A).
 defects and adverse drug experiences
 not previously reported to FDA?
------------------------------------------------------------------------
What are the requirements for submitting  514.80(b)(4)(iv)(B).
 adverse drug experiences cited in
 literature?
------------------------------------------------------------------------
What are the requirements for submitting  514.80(b)(4)(iv)(C).
 adverse drug experiences in
 postapproval studies and clinical
 trials?
------------------------------------------------------------------------
What are the requirements for reporting   514.80(b)(4)(v) Summary report
 increases in the frequency of serious,    of increased frequency of
 expected, and unexpected adverse drug     adverse drug experience.
 experiences?
------------------------------------------------------------------------
                                          514.80(b)(5) Other reporting.
------------------------------------------------------------------------
Can FDA request that an applicant submit  514.80(b)(5)(i) Special drug
 information at different times than       experience report.
 stated specifically in this regulation?
------------------------------------------------------------------------
What are the requirements for submission  514.80(b)(5)(ii)
 of advertisement and promotional          Advertisements and
 labeling to FDA?                          promotional labeling.
------------------------------------------------------------------------
What are the requirements for adding a    514.80(b)(5)(iii)
 new distributor to the approved           Distributor's statement.
 application?
------------------------------------------------------------------------
What labels and how many labels need to   514.80(b)(5)(iii)(A).
 be submitted for review?
------------------------------------------------------------------------
What changes are required and allowed to  514.80(b)(5)(iii)(A)(1).
 distributor labeling?
------------------------------------------------------------------------
What are the requirements for making      514.80(b)(5)(iii)(A)(2).
 other changes to the distributor
 labeling?
------------------------------------------------------------------------
What information should be included in    514.80(b)(5)(iii)(B)(1)
 each new distributor's signed             through (b)(5)(iii)(B)(5).
 statement?
------------------------------------------------------------------------
What are the conditions for submitting    514.80(c) Multiple
 information that is common to more than   applications.
 one application? (i.e., can I submit
 common information to one application?)
------------------------------------------------------------------------
What information has to be submitted to   514.80(c)(1) through (c)(4).
 the common application and related
 application?
------------------------------------------------------------------------
What reports must be submitted to FDA     514.80(d) Format for
 electronically?                           Submissions.
How can I apply for a waiver from the
 electronic reporting requirements?
How do I obtain Form FDA 1932 and Form
 FDA 2301?
------------------------------------------------------------------------
How long must I maintain records and      514.80(e) Records to be
 reports required by this section?         maintained.
------------------------------------------------------------------------
What are the requirements for allowing    514.80(f) Access to records
 access to these records and reports,      and reports.
 and copying by authorized FDA officer
 or employee?
------------------------------------------------------------------------
Where do I mail reports that are not      514.80(g) Mailing addresses.
 required to be submitted
 electronically?
------------------------------------------------------------------------
What happens if the applicant fails to    514.80(h) Withdrawal of
 establish, maintain, or make the          approval.
 required reports?
What happens if the applicant refuses to
 allow FDA access to, and/or copying and/
 or verify records and reports?
------------------------------------------------------------------------
Does an adverse drug experience reflect   514.80(i) Disclaimer.
 a conclusion that the report or
 information constitutes an admission
 that the drug caused an adverse effect?
------------------------------------------------------------------------

    (a) Applicability. (1) Each applicant must establish and maintain 
indexed and complete files containing full records of all information 
pertinent to safety or effectiveness of a new animal drug that has not 
been previously submitted as part of the NADA or ANADA. Such records 
must include information from domestic as well as foreign sources. Each 
nonapplicant must establish and maintain indexed and complete files 
containing full records of all information pertinent to safety or 
effectiveness of a new animal drug that

[[Page 109]]

is received or otherwise obtained by the nonapplicant. Such records must 
include information from domestic as well as foreign sources.
    (2) Each applicant must submit reports of data, studies, and other 
information concerning experience with new animal drugs to the Food and 
Drug Administration (FDA) for each approved NADA and ANADA, as required 
in this section. A nonapplicant must submit data, studies, and other 
information concerning experience with new animal drugs to the 
appropriate applicant, as required in this section. The applicant, in 
turn, must report the nonapplicant's data, studies, and other 
information to FDA. Applicants and nonapplicants must submit data, 
studies, and other information described in this section from domestic, 
as well as foreign sources.
    (3) FDA reviews the records and reports required in this section to 
facilitate a determination under section 512(e) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 360b(e)) as to whether there may be 
grounds for suspending or withdrawing approval of the NADA or ANADA.
    (4) The requirements of this section also apply to any approved Type 
A medicated article. In addition, the requirements contained in Sec. 
514.80(b)(1), (b)(2), (b)(4)(iv), and (b)(4)(v) apply to any approved 
Type A medicated article incorporated in animal feeds.
    (5) The records and reports referred to in this section are in 
addition to those required by the current good manufacturing practice 
regulations in parts 211, 225, and 226 of this chapter.
    (b) Reporting requirements--(1) Three-day NADA/ANADA field alert 
report. This report provides information pertaining to product and 
manufacturing defects that may result in serious adverse drug events. 
The applicant (or nonapplicant through the applicant) must submit the 
report to the appropriate FDA District Office or local FDA resident post 
within 3 working days of first becoming aware that a defect may exist. 
The information initially may be provided by telephone or other 
telecommunication means, with prompt written followup using Form FDA 
1932 ``Veterinary Adverse Drug Reaction, Lack of Effectiveness, Product 
Defect Report.'' The mailing cover for these reports must be plainly 
marked ``3-Day NADA/ANADA Field Alert Report.'' If the applicant elects 
to also report directly to the FDA's Center for Veterinary Medicine 
(CVM), the applicant must submit the report to CVM in electronic format 
as described in paragraph (d)(1) of this section, unless the applicant 
obtains a waiver under paragraph (d)(2) of this section or FDA requests 
the report in an alternate format.
    (2) Fifteen-day NADA/ANADA alert report--(i) Initial report. This 
report provides information on each serious, unexpected adverse drug 
event, regardless of the source of the information. The applicant (or 
nonapplicant through the applicant) must submit the report to FDA within 
15 working days of first receiving the information. The report must be 
submitted to FDA in electronic format as described in paragraph (d)(1) 
of this section, unless the applicant obtains a waiver under paragraph 
(d)(2) of this section or FDA requests the report in an alternate 
format.
    (ii) Followup report. The applicant must promptly investigate all 
adverse drug events that are the subject of 15-day NADA/ANADA alert 
reports. If this investigation reveals significant new information, a 
followup report must be submitted within 15 working days of receiving 
such information. A followup report must be submitted to FDA in 
electronic format as described in paragraph (d)(1) of this section, 
unless the applicant obtains a waiver under paragraph (d)(2) of this 
section or FDA requests the report in an alternate format. The followup 
report must state the date of the initial report and provide the 
additional information. If additional information is sought but not 
obtained within 3 months of the initial report, a followup report is 
required describing the steps taken and why additional information was 
not obtained.
    (3) Nonapplicant report. Nonapplicants must forward reports of 
adverse drug experiences to the applicant within 3 working days of first 
receiving the information. The applicant must then submit the report(s) 
to FDA as required in this section. The nonapplicant must maintain 
records of all nonapplicant reports, including the

[[Page 110]]

date the nonapplicant received the information concerning adverse drug 
experiences, the name and address of the applicant, and a copy of the 
adverse drug experience report including the date such report was 
submitted to the applicant. If the nonapplicant elects to also report 
directly to FDA, the nonapplicant must submit the report to FDA in 
electronic format as described in paragraph (d)(1) of this section, 
unless the nonapplicant obtains a waiver under paragraph (d)(2) of this 
section or FDA requests the report in an alternate format.
    (4) Periodic drug experience report. This report must be accompanied 
by a completed Form FDA 2301 ``Transmittal of Periodic Reports and 
Promotional Materials for New Animal Drugs.'' It must be submitted every 
6 months for the first 2 years following approval of an NADA or ANADA 
and yearly thereafter. Reports required by this section must contain 
data and information for the full reporting period. The 6-month periodic 
drug experience reports must be submitted within 30 days following the 
end of the 6-month reporting period. The yearly periodic drug experience 
reports must be submitted within 90 days of the anniversary date of the 
approval of the NADA or ANADA. Any previously submitted information 
contained in the report must be identified as such. For yearly (annual) 
periodic drug experience reports, the applicant may petition FDA to 
change the date of submission or frequency of reporting, and after 
approval of such petition, file such reports on the new filing date or 
at the new reporting frequency. Also, FDA may require a report at 
different times or more frequently. The periodic drug experience report 
must contain the following:
    (i) Distribution data. (A) Information about the distribution of 
each new animal drug product, including information on any distributor-
labeled product. This information must include the total number of 
distributed units of each size, strength, or potency (e.g., 100,000 
bottles of 100 5-milligram tablets; 50,000 10-milliliter vials of 5-
percent solution). This information must be presented in two categories: 
Quantities distributed domestically and quantities exported.
    (B) Applicants submitting annual sales and distribution reports for 
antimicrobial new animal drug products under Sec. 514.87 have the 
option not to report distribution data under paragraph (b)(4)(i)(A) of 
this section for the approved applications that include these same 
products, but only provided each of the following conditions are met:
    (1) Applicants must have submitted complete periodic drug experience 
reports under this section for such applications for at least 2 full 
years after the date of their initial approval.
    (2) Applicants must ensure that the beginning of the reporting 
period for the annual periodic drug experience reports for such 
applications is January 1. For applications that currently have a 
reporting period that begins on a date other than January 1, applicants 
must request a change in reporting submission date such that the 
reporting period begins on January 1 and ends on December 31, as 
described in paragraph (b)(4) of this section.
    (3) Applicants that change their reporting submission date must also 
submit a special drug experience report, as described in paragraph 
(b)(5)(i) of this section, that addresses any gaps in distribution data 
caused by the change in date of submission.
    (4) Applicants who choose not to report under paragraph (b)(4)(i)(A) 
of this section must ensure that full sales and distribution data for 
each product approved under such applications are alternatively reported 
under Sec. 514.87, including products that are labeled for use only in 
nonfood-producing animals.
    (ii) Labeling. Applicant and distributor current package labeling, 
including package inserts (if any). For large-size package labeling or 
large shipping cartons, a representative copy must be submitted (e.g., a 
photocopy of pertinent areas of large feed bags). A summary of any 
changes in labeling made since the last report (listed by date of 
implementation) must be included with the labeling or if there have been 
no changes, a statement of such fact must be included with the labeling.

[[Page 111]]

    (iii) Nonclinical laboratory studies and clinical data not 
previously reported.
    (A) Copies of in vitro studies (e.g., mutagenicity) and other 
nonclinical laboratory studies conducted by or otherwise obtained by the 
applicant.
    (B) Copies of published clinical trials of the new animal drug (or 
abstracts of them) including clinical trials on safety and 
effectiveness, clinical trials on new uses, and reports of clinical 
experience pertinent to safety conducted by or otherwise obtained by the 
applicant. Review articles, papers, and abstracts in which the drug is 
used as a research tool, promotional articles, press clippings, and 
papers that do not contain tabulations or summaries of original data are 
not required to be reported.
    (C) Descriptions of completed clinical trials conducted by or for 
the applicant must be submitted no later than 1 year after completion of 
research. Supporting information is not to be reported.
    (iv) Adverse drug experiences. (A) Product/manufacturing defects and 
adverse drug experiences not previously reported under paragraphs (b)(1) 
and (2) of this section must be reported individually to FDA in 
electronic format as described in paragraph (d)(1) of this section, 
unless the applicant obtains a waiver under paragraph (d)(2) of this 
section or FDA requests the report in an alternate format.
    (B) Reports of adverse drug experiences in the literature must be 
noted in the periodic drug experience report. A bibliography of 
pertinent references must be included with the report. Upon FDA's 
request, the applicant must provide a full text copy of these 
publications.
    (C) Reports of previously not reported adverse drug experiences that 
occur in postapproval studies must be reported individually to FDA in 
electronic format as described in paragraph (d)(1) of this section, 
unless the applicant obtains a waiver under paragraph (d)(2) of this 
section or FDA requests the report in an alternate format.
    (v) Summary report of increased frequency of adverse drug 
experience. The applicant must periodically review the incidence of 
reports of adverse drug experiences to determine if there has been an 
increased frequency of serious (expected and unexpected) adverse drug 
events. The applicant must evaluate the increased frequency of serious 
(expected or unexpected) adverse drug events at least as often as 
reporting of periodic drug experience reports. The applicant must report 
the increased frequency of serious (expected and unexpected) adverse 
drug events in the periodic drug experience report. Summaries of reports 
of increased frequency of adverse drug events must be submitted in 
narrative form. The summaries must state the time period on which the 
increased frequency is based, time period comparisons in determining 
increased frequency, references to any reports previously submitted 
under paragraphs (b)(1), (2), and (3) and (b)(4)(iv)(A) and (C) of this 
section, the method of analysis, and the interpretation of the results. 
The summaries must be submitted in a separate section within the 
periodic drug experience report.
    (5) Other reporting--(i) Special drug experience report. Upon 
written request, FDA may require that the applicant submit a report 
required under Sec. 514.80 at different times or more frequently than 
the timeframes stated in Sec. 514.80.
    (ii) Advertisements and promotional labeling. The applicant must 
submit at the time of initial dissemination one set of specimens of 
mailing pieces and other labeling for prescription and over-the-counter 
new animal drugs. For prescription new animal drugs, the applicant must 
also submit one set of specimens of any advertisement at the time of 
initial publication or broadcast. Mailing pieces and labeling designed 
to contain product samples must be complete except that product samples 
may be omitted. Each submission of promotional labeling or 
advertisements must be accompanied by a completed Form FDA 2301.
    (iii) Distributor's statement. At the time of initial distribution 
of a new animal drug product by a distributor, the applicant must submit 
a special drug experience report accompanied by a completed Form FDA 
2301 containing the following:
    (A) The distributor's current product labeling.

[[Page 112]]

    (1) The distributor's labeling must be identical to that in the 
approved NADA/ANADA except for a different and suitable proprietary name 
(if used) and the name and address of the distributor. The name and 
address of the distributor must be preceded by an appropriate qualifying 
phrase as permitted by the regulations such as ``manufactured for'' or 
``distributed by.''
    (2) Other labeling changes must be the subject of a supplemental 
NADA or ANADA as described under Sec. 514.8.
    (B) A signed statement by the distributor stating:
    (1) The category of the distributor's operations (e.g., wholesale or 
retail),
    (2) That the distributor will distribute the new animal drug only 
under the approved labeling,
    (3) That the distributor will promote the product only for use under 
the conditions stated in the approved labeling,
    (4) That the distributor will adhere to the records and reports 
requirements of this section, and
    (5) That the distributor is regularly and lawfully engaged in the 
distribution or dispensing of prescription products if the product is a 
prescription new animal drug.
    (c) Multiple applications. Whenever an applicant is required to 
submit a periodic drug experience report under the provisions of Sec. 
514.80(b)(4) with respect to more than one approved NADA or ANADA for 
preparations containing the same new animal drug so that the same 
information is required to be reported for more than one application, 
the applicant may elect to submit as a part of the report for one such 
application (the primary application) all the information common to such 
applications in lieu of reporting separately and repetitively on each. 
If the applicant elects to do this, the applicant must do the following:
    (1) State when a report applies to multiple applications and 
identify all related applications for which the report is submitted by 
NADA or ANADA number.
    (2) Ensure that the primary application contains a list of the NADA 
or ANADA numbers of all related applications.
    (3) Submit a completed Form FDA 2301 to the primary application and 
each related application with reference to the primary application by 
NADA/ANADA number and submission date for the complete report of the 
common information.
    (4) All other information specific to a particular NADA/ANADA must 
be included in the report for that particular NADA/ANADA.
    (d) Format for submissions--(1) Electronic submissions. Except as 
provided in paragraph (d)(2) of this section, reports submitted to FDA 
under paragraphs (b)(2)(i) and (ii), (b)(3), and (b)(4)(iv)(A) and (C) 
of this section and reports submitted to CVM under paragraph (b)(1) of 
this section must be submitted in an electronic format that FDA can 
process, review, and archive. Data provided in electronic submissions 
must be in conformance with the data elements in Form FDA 1932 and FDA 
technical documents describing transmission. As necessary, FDA will 
issue updated technical documents on how to provide the electronic 
submission (e.g., method of transmission and processing, media, file 
formats, preparation, and organization of files). Unless requested by 
FDA, paper copies of reports submitted electronically should not be 
submitted to FDA.
    (2) Waivers. An applicant or nonapplicant may request, in writing, a 
temporary waiver of the electronic submission requirements in paragraph 
(d)(1) of this section. The initial request may be by telephone or email 
to CVM's Division of Veterinary Product Safety, with prompt written 
followup submitted as a letter to the application(s). FDA will grant 
waivers on a limited basis for good cause shown. If FDA grants a waiver, 
the applicant or nonapplicant must comply with the conditions for 
reporting specified by FDA upon granting the waiver.
    (3) Paper forms. If approved by FDA before use, a computer-generated 
equivalent of Form FDA 1932 may be used for reports submitted to the 
appropriate FDA District Office or local FDA resident post under 
paragraph (b)(1) of this section and to FDA under paragraph (d)(2) of 
this section, and a computer-generated equivalent of Form FDA 2301 may 
be used for reports

[[Page 113]]

submitted to FDA under paragraph (b)(4) of this section. Form FDA 1932 
may be obtained on the FDA website, by telephoning CVM's Division of 
Veterinary Product Safety, or by submitting a written request to the 
following address: Food and Drug Administration, Center for Veterinary 
Medicine, Division of Veterinary Product Safety (HFV-240), 7500 Standish 
Pl., Rockville, MD 20855-2764. Form FDA 2301 may be obtained on the FDA 
website, by telephoning CVM's Division of Surveillance (HFV-210), or by 
submitting a written request to the following address: Food and Drug 
Administration, Center for Veterinary Medicine, Division of Surveillance 
(HFV-210), 7500 Standish Pl., Rockville, MD 20855-2764.
    (e) Records to be maintained. The applicants and nonapplicants must 
maintain records and reports of all information required by this section 
for a period of 5 years after the date of submission.
    (f) Access to records and reports. The applicant and nonapplicant 
must, upon request from any authorized FDA officer or employee, at all 
reasonable times, permit such officer or employee to have access to copy 
and to verify all such required records and reports.
    (g) Mailing addresses. Three-day alert reports must be submitted to 
the appropriate FDA District Office or local FDA resident post. 
Addresses for District Offices and resident posts may be obtained on the 
FDA website. Other reports not required to be submitted to FDA in 
electronic format must be submitted to the following address: Food and 
Drug Administration, Center for Veterinary Medicine, Document Control 
Unit (HFV-199), 7500 Standish Pl., Rockville, MD 20855-2764.
    (h) Withdrawal of approval. If FDA finds that the applicant has 
failed to establish the required records, or has failed to maintain 
those records, or failed to make the required reports, or has refused 
access to an authorized FDA officer or employee to copy or to verify 
such records or reports, FDA may withdraw approval of the application to 
which such records or reports relate. If FDA determines that withdrawal 
of the approval is necessary, the agency shall give the applicant notice 
and opportunity for hearing, as provided in Sec. 514.200, on the 
question of whether to withdraw approval of the application.
    (i) Disclaimer. Any report or information submitted under this 
section and any release of that report or information by FDA will be 
without prejudice and does not necessarily reflect a conclusion that the 
report or information constitutes an admission that the drug caused or 
contributed to an adverse event. A person need not admit, and may deny, 
that the report or information constitutes an admission that a drug 
caused or contributed to an adverse event.

[68 FR 15365, Mar. 31, 2003, as amended at 81 FR 29141, May 11, 2016; 85 
FR 45512, July 29, 2020]



Sec. 514.87  Annual reports for antimicrobial animal drug sales 
and distribution.

    (a) The applicant for each new animal drug product approved under 
section 512 of the Federal Food, Drug, and Cosmetic Act, or 
conditionally approved under section 571 of the Federal Food, Drug, and 
Cosmetic Act, and containing an antimicrobial active ingredient, must 
submit an annual report to FDA on the amount of each such antimicrobial 
active ingredient in the drug that is sold or distributed in the 
reporting year for use in food-producing animal species, including 
information on any distributor-labeled product.
    (b) This report must identify the approved or conditionally approved 
application and must include the following information for each new 
animal drug product described in paragraph (a) of this section:
    (1) A listing of each antimicrobial active ingredient contained in 
the product;
    (2) A description of each product sold or distributed by unit, 
including the container size, strength, and dosage form of such product 
units;
    (3) For each such product, a listing of the target animal species, 
indications, and production classes that are specified on the approved 
label;
    (4) For each such product, the number of units sold or distributed 
in the United States (i.e., domestic sales) for each month of the 
reporting year; and

[[Page 114]]

    (5) For each such product, the number of units sold or distributed 
outside the United States (i.e., quantities exported) for each month of 
the reporting year.
    (c) Each report must also provide a species-specific estimate of the 
percentage of each product described in paragraph (b)(2) of this section 
that was sold or distributed domestically in the reporting year for use 
in any of the following animal species categories, but only for such 
species that appear on the approved label: Cattle, swine, chickens, 
turkeys. The total of the species-specific percentages reported for each 
product must account for 100 percent of its sales and distribution; 
therefore, a fifth category of ``other species/unknown'' must also be 
reported.
    (d) Each report must:
    (1) Be submitted not later than March 31 each year;
    (2) Cover the period of the preceding calendar year; and
    (3) Be submitted using Form FDA 3744, ``Antimicrobial Animal Drug 
Distribution Report.''
    (e) Sales and distribution data and information reported under this 
section will be considered to fall within the exemption for confidential 
commercial information established in Sec. 20.61 of this chapter and 
will not be publicly disclosed, except that summary reports of such 
information aggregated in such a way that does not reveal information 
that is not available for public disclosure under this provision will be 
prepared by FDA and made available to the public as provided in 
paragraph (f) of this section.
    (f) FDA will publish an annual summary report of the data and 
information it receives under this section for each calendar year by 
December 31 of the following year. Such annual reports must include a 
summary of sales and distribution data and information by antimicrobial 
drug class and may include additional summary data and information as 
determined by FDA. In order to protect confidential commercial 
information, each individual datum appearing in the summary report must:
    (1) Reflect combined product sales and distribution data and 
information obtained from three or more distinct sponsors of approved 
products that were actively sold or distributed that reporting year, and
    (2) Be reported in a manner consistent with protecting both national 
security and confidential commercial information.

[81 FR 29141, May 11, 2016]



Sec. 514.100  Evaluation and comment on applications.

    (a) After the filed application has been evaluated, the applicant 
will be furnished written comment on any apparent deficiencies in the 
application.
    (b) When the description of the methods used in, and the facilities 
and controls used for, the manufacture, processing, and packing of such 
new animal drug appears adequate on its face, but it is not feasible to 
reach a conclusion as to the safety and effectiveness of the new animal 
drug solely from consideration of this description, the applicant may be 
notified that an establishment inspection is required to verify their 
adequacy.
    (c) A request for samples of a new animal drug or any edible tissues 
and byproducts of animals treated with such a drug, shall specify the 
quantity deemed adequate to permit tests of analytical methods to 
determine their adequacy for regulatory purposes. The request should be 
made as early in the 180-day period as possible to assure timely 
completion. The date used for computing the 180-day limit for the 
purposes of section 512(c) of the act shall be moved forward 1 day for 
each day after the mailing date of the request until all of the 
requested samples are received. If the samples are not received within 
90 days after the request, the application will be considered withdrawn 
without prejudice.
    (d) The information contained in an application may be insufficient 
to determine whether a new animal drug is safe or effective in use if it 
fails to include (among other things) a statement showing whether such 
drug is to be limited to prescription sale and exempt under section 
502(f) of the act from the requirement that its labeling bear adequate 
directions for lay use. If such drug is to be exempt, the information 
may also be insufficient if:

[[Page 115]]

    (1) The specimen labeling proposed fails to bear adequate 
information for professional use including indications, effects, 
dosages, routes, methods, and frequency and duration of administration 
and any relevant hazards, contraindications, side effects, and 
precautions under which practitioners licensed by law to administer such 
drug can use the drug for the purposes for which it is intended, 
including all purposes for which it is to be advertised, or represented, 
in accordance with Sec. 201.105 of this chapter, and information 
concerning hazards, contraindications, side effects, and precautions 
relevant with respect to any uses for which such drug is to be 
prescribed.
    (2) The application fails to show that the labeling and advertising 
of such drug will offer the drug for use only under those conditions for 
which it is offered in the labeling that is part of the application.
    (3) The application fails to show that all labeling that furnishes 
or purports to furnish information for professional use of such drug 
will contain, in the same language and emphasis, the information for use 
including indications, effects, dosages, routes, methods, and frequency 
and duration of administration and any relevant warnings, hazards, 
contraindications, side effects, and precautions, which is contained in 
the labeling that is part of the application in accordance with Sec. 
201.105 of this chapter.
    (e) The information contained in an application will be considered 
insufficient to determine whether a new animal drug is safe and 
effective for use when there is a refusal or failure upon written notice 
to furnish inspectors authorized by the Food and Drug Administration an 
adequate opportunity to inspect the facilities, controls, and records 
pertinent to the application.
    (f) On the basis of preliminary consideration of an application or 
supplemental application containing typewritten or other draft labeling 
in lieu of final printed labeling, an applicant may be informed that 
such application is approvable when satisfactory final printed labeling 
identical in content to such draft copy is submitted.
    (g) When an application has been found incomplete on the basis of a 
need for the kind of information described in Sec. 514.6, such 
application shall be considered withdrawn without prejudice to future 
filing on the date of issuance of the letter citing the inadequacies 
contained in the application, unless within 30 days the sponsor chooses 
to avail himself of the opportunity for hearing as prescribed by Sec. 
514.111.



Sec. 514.105  Approval of applications.

    (a) The Commissioner shall forward for publication in the Federal 
Register a regulation prescribing the conditions under which the new 
animal drug may be used, including the name and address of the 
applicant; the conditions and indications for use covered by the 
application; any tolerance, withdrawal period, or other use 
restrictions; any tolerance required for the new animal drug substance 
or its metabolites in edible products of food-producing animals; and, if 
such new animal drug is intended for use in animal feed, appropriate 
purposes and conditions of use (including special labeling requirements) 
applicable to any animal feed; and such other information the 
Commissioner deems necessary to assure safe and effective use.
    (b) He shall notify the applicant by sending him a copy of the 
proposed publication as described in paragraph (a)(1) of this section.

[40 FR 13825, Mar. 27, 1975, as amended at 51 FR 7392, Mar. 3, 1986; 64 
FR 63203, Nov. 19, 1999]



Sec. 514.106  Approval of supplemental applications.

    (a) Within 180 days after a supplement to an approved application is 
filed pursuant to Sec. 514.8, the Commissioner shall approve the 
supplemental application in accordance with procedures set forth in 
Sec. 514.105(a)(1) and (2) if he/she determines that the application 
satisfies the requirements of applicable statutory provisions and 
regulations.
    (b) The Commissioner will assign a supplemental application to its 
proper category to ensure processing of the application.
    (1) Category I. Supplements that ordinarily do not require a 
reevaluation of any of the safety or effectiveness data

[[Page 116]]

in the parent application. Category I supplements include the following:
    (i) A corporate change that alters the identity or address of the 
sponsor of the new animal drug application (NADA).
    (ii) The sale, purchase, or construction of manufacturing 
facilities.
    (iii) The sale or purchase of an NADA.
    (iv) A change in container, container style, shape, size, or 
components.
    (v) A change in approved labeling (color, style, format, addition, 
deletion, or revision of certain statements, e.g., trade name, storage, 
expiration dates, etc).
    (vi) A change in promotional material for a prescription new animal 
drug not exempted by Sec. 514.8(c)(2)(i)(C)(1) through (c)(2)(i)(C)(3).
    (vii) Changes in manufacturing processes that do not alter the 
method of manufacture or change the final dosage form.
    (viii) A change in bulk drug shipments.
    (ix) A change in an analytical method or control procedures that do 
not alter the approved standards.
    (x) A change in an expiration date.
    (xi) Addition of an alternate manufacturer, repackager, or relabeler 
of the drug product.
    (xii) Addition of an alternate supplier of the new drug substance.
    (xiii) A change permitted in advance of approval as described under 
Sec. 514.8(b)(3).
    (2) Category II. Supplements that may require a reevaluation of 
certain safety or effectiveness data in the parent application. Category 
II supplements include the following:
    (i) A change in the active ingredient concentration or composition 
of the final product.
    (ii) A change in quality, purity, strength, and identity 
specifications of the active or inactive ingredients.
    (iii) A change in dose (amount of drug administered per dose).
    (iv) A change in the treatment regimen (schedule of dosing).
    (v) Addition of a new therapeutic claim to the approved uses of the 
product.
    (vi) Addition of a new or revised animal production claim.
    (vii) Addition of a new species.
    (viii) A change in the prescription or over-the-counter status of a 
drug product.
    (ix) A change in statements regarding side effects, warnings, 
precautions, and contraindications, except the addition of approved 
statements to container, package, and promotional labeling, and 
prescription drug advertising.
    (x) A change in the drug withdrawal period prior to slaughter or in 
the milk discard time.
    (xi) A change in the tolerance for drug residues.
    (xii) A change in analytical methods for drug residues.
    (xiii) A revised method of synthesis or fermentation of the new drug 
substance.
    (xiv) Updating or changes in the manufacturing process of the new 
drug substance and/or final dosage form (other than a change in 
equipment that does not alter the method of manufacture of a new animal 
drug, or a change from one commercial batch size to another without any 
change in manufacturing procedure), or changes in the methods, 
facilities, or controls used for the manufacture, processing, packaging, 
or holding of the new animal drug (other than use of an establishment 
not covered by the approval that is in effect) that give increased 
assurance that the drug will have the characteristics of identity, 
strength, quality, and purity which it purports or is represented to 
possess.

[55 FR 46052, Nov. 1, 1990; 55 FR 49973, Dec. 3, 1990; 56 FR 12422, Mar. 
25, 1991, as amended at 71 FR 74785, Dec. 13, 2006]



Sec. 514.110  Reasons for refusing to file applications.

    (a) The date of receipt of an application for a new animal drug 
shall be the date on which the application shall be deemed to be filed.
    (b) An application for a new animal drug shall not be considered 
acceptable for filing for any of the following reasons:
    (1) It does not contain complete and accurate English translations 
of any pertinent part in a foreign language.
    (2) Fewer than three copies are submitted.

[[Page 117]]

    (3) It is incomplete on its face in that it is not properly 
organized and indexed.
    (4) On its face the information concerning required matter is so 
inadequate that the application is clearly not approvable.
    (5) The new animal drug is to be manufactured, prepared, propagated, 
compounded, or processed in whole or in part in any State in an 
establishment that has not been registered or exempted from registration 
under the provisions of section 510 of the act.
    (6) The sponsor does not reside or maintain a place of business 
within the United States and the application has not been countersigned 
by an attorney, agent, or other representative of the applicant, which 
representative resides in the United States and has been duly authorized 
to act on behalf of the applicant and to receive communications on all 
matters pertaining to the application.
    (7) The new animal drug is a drug subject to licensing under the 
animal virus, serum, and toxin law of March 4, 1913 (37 Stat. 832; 21 
U.S.C. 151 et seq. ). Such applications will be referred to the U.S. 
Department of Agriculture for action.
    (8) It fails to include, with respect to each nonclinical laboratory 
study contained in the application, either a statement that the study 
was conducted in compliance with the good laboratory practice 
regulations set forth in part 58 of this chapter, or, if the study was 
not conducted in compliance with such regulations, a brief statement of 
the reasons for the noncompliance.
    (9) [Reserved]
    (10) The applicant fails to submit a complete environmental 
assessment under Sec. 25.40 of this chapter or fails to provide 
sufficient information to establish that the requested action is subject 
to categorical exclusion under Sec. 25.30 or Sec. 25.33 of this 
chapter.
    (c) If an application is determined not to be acceptable for filing, 
the applicant shall be notified within 30 days of receipt of the 
application and shall be given the reasons therefore.
    (d) If the applicant disputes the findings that his application is 
not acceptable for filing, he may make written request that the 
application be filed over protest, in which case it will be filed as of 
the day originally received.

[40 FR 13825, Mar. 27, 1975, as amended at 50 FR 7517, Feb. 22, 1985; 50 
FR 16668, Apr. 26, 1985; 62 FR 40600, July 29, 1997]



Sec. 514.111  Refusal to approve an application.

    (a) The Commissioner shall, within 180 days after the filing of the 
application, inform the applicant in writing of his intention to issue a 
notice of opportunity for a hearing on a proposal to refuse to approve 
the application, if the Commissioner determines upon the basis of the 
application, or upon the basis of other information before him with 
respect to a new animal drug, that:
    (1) The reports of investigations required to be submitted pursuant 
to section 512(b) of the act do not include adequate tests by all 
methods reasonably applicable to show whether or not such drug is safe 
for use under the conditions prescribed, recommended, or suggested in 
the proposed labeling thereof; or
    (2) The results of such tests show that such drug is unsafe for use 
under such conditions or do not show that such drug is safe for use 
under such conditions; or
    (3) The methods used in and the facilities and controls used for the 
manufacture, processing, and packing of such drug are inadequate to 
preserve its identity, strength, quality, and purity; or
    (4) Upon the basis of the information submitted to the Food and Drug 
Administration as part of the application, or upon the basis of any 
other information before it with respect to such drug, it has 
insufficient information to determine whether such drug is safe for use 
under such conditions. In making this determination the Commissioner 
shall consider, among other relevant factors:
    (i) The probable consumption of such drug and of any substance 
formed in or on food because of the use of such drug;
    (ii) The cumulative effect on man or animal of such drug, taking 
into account any chemically or pharmacologically related substances;

[[Page 118]]

    (iii) Safety factors which, in the opinion of experts qualified by 
scientific training and experience to evaluate the safety of such drugs, 
are appropriate for the use of animal experimentation data; and
    (iv) Whether the conditions of use prescribed, recommended, or 
suggested in the proposed labeling are reasonably certain to be followed 
in practice; or
    (5) Evaluated on the basis of information submitted as part of the 
application and any other information before the Food and Drug 
Administration with respect to such drug, there is lack of substantial 
evidence as defined in Sec. 514.4.
    (6) Failure to include an appropriate proposed tolerance for 
residues in edible products derived from animals or a withdrawal period 
or other restrictions for use of such drug if any tolerance or 
withdrawal period or other restrictions for use are required in order to 
assure that the edible products derived from animals treated with such 
drug will be safe.
    (7) Based on a fair evaluation of all material facts, the labeling 
is false or misleading in any particular; or
    (8) Such drug induces cancer when ingested by man or animal or, 
after appropriate tests for evaluation of the safety of such drug, 
induces cancer in man or animal, except that this subparagraph shall not 
apply with respect to such drug if the Commissioner finds that, under 
the conditions of use specified in proposed labeling and reasonably 
certain to be followed in practice:
    (i) Such drug will not adversely affect the animal for which it is 
intended; and
    (ii) No residue of such drug will be found (by methods of 
examination prescribed or approved by the Commissioner by regulations) 
in any edible portion of such animal after slaughter or in any food 
yielded by, or derived from the living animals.
    (9) The applicant fails to submit an adequate environmental 
assessment under Sec. 25.40 of this chapter or fails to provide 
sufficient information to establish that the requested action is subject 
to categorical exclusion under Sec. 25.30 or Sec. 25.33 of this 
chapter.
    (10) The drug fails to satisfy the requirements of subpart E of part 
500 of this chapter.
    (11) Any nonclinical laboratory study that is described in the 
application and that is essential to show that the drug is safe for use 
under the conditions prescribed, recommended, or suggested in its 
proposed labeling, was not conducted in compliance with the good 
laboratory practice regulations as set forth in part 58 of this chapter 
and no reason for the noncompliance is provided or, if it is, the 
differences between the practices used in conducting the study and the 
good laboratory practice regulations do not support the validity of the 
study.
    (12) The drug will be produced in whole or in part in an 
establishment that is not registered and not exempt from registration 
under section 510 of the Federal Food, Drug, and Cosmetic Act and part 
207 of this chapter.
    (b) The Commissioner, as provided in Sec. 514.200 of this chapter, 
shall expeditiously notify the applicant of an opportunity for a hearing 
on the question of whether such application is approvable, unless by the 
30th day following the date of issuance of the letter informing the 
applicant of the intention to issue a notice of opportunity for a 
hearing the applicant:
    (1) Withdraws the application; or
    (2) Waives the opportunity for a hearing; or
    (3) Agrees with the Commissioner on an additional period to precede 
issuance of such notice of hearing.

[40 FR 13825, Mar. 27, 1975, as amended at 43 FR 22675, May 26, 1978; 44 
FR 16007, Mar. 16, 1979; 50 FR 7517, Feb. 22, 1985; 50 FR 16668, Apr. 
26, 1985; 52 FR 49588, Dec. 31, 1987; 54 FR 18280, Apr. 28, 1989; 62 FR 
40600, July 29, 1997; 63 FR 10770, Mar. 5, 1998; 64 FR 40757, July 28, 
1999; 64 FR 63204, Nov. 19, 1999; 81 FR 60221, Aug. 31, 2016]



Sec. 514.115  Withdrawal of approval of applications.

    (a) The Secretary may suspend approval of an application approved 
pursuant to section 512(c) of the act and give the applicant prompt 
notice of his action and afford the applicant the opportunity for an 
expedited hearing on a

[[Page 119]]

finding that there is an imminent hazard to the health of man or of the 
animals for which such new animal drug or animal feed is intended.
    (b) The Commissioner shall notify in writing the person holding an 
application approved pursuant to section 512(c) of the act and afford an 
opportunity for a hearing on a proposal to withdraw approval of such 
application if he finds:
    (1) That the application contains any untrue statement of a material 
fact; or
    (2) That the applicant has made any changes from the standpoint of 
safety or effectiveness beyond the variations provided for in the 
application unless he has supplemented the application by filing with 
the Secretary adequate information respecting all such changes and 
unless there is in effect an approval of the supplemental application, 
or such changes are those for which written authorization or approval is 
not required as provided for in Sec. 514.8. The supplemental 
application shall be treated in the same manner as the original 
application.
    (3) That in the case of an application for use of a new animal drug 
approved or deemed approved pursuant to section 512(c) of the act:
    (i) Experience or scientific data show that such drug is unsafe for 
use under the conditions of use upon the basis of which the application 
was approved; or
    (ii) New evidence not contained in such application or not available 
to the Secretary until after such application was approved, or tests by 
new methods, or tests by methods not deemed reasonably applicable when 
such application was approved, evaluated together with the evidence 
available to the Secretary when the application was approved, shows that 
such drug is not shown to be safe for use under the conditions of use 
upon the basis of which the application was approved or that section 512 
(d)(1)(H) of the act applies to such drug; or
    (iii) On the basis of new information before him with respect to 
such drug, evaluated together with the evidence available to him when 
the application was approved, there is a lack of substantial evidence 
that such drug will have the effect it purports or is represented to 
have under the conditions of use prescribed, recommended, or suggested 
in the labeling thereof.
    (4) That any nonclinical laboratory study that is described in the 
application and that is essential to show that the drug is safe for use 
under the conditions prescribed, recommended, or suggested in its 
proposed labeling, was not conducted in compliance with the good 
laboratory practice regulations as set forth in part 58 of this chapter 
and no reason for the noncompliance is provided or, if it is, the 
differences between the practices used in conducting the study and the 
good laboratory practice regulations do not support the validity of the 
study.
    (c) The Commissioner may notify in writing the person holding an 
application approved pursuant to section 512(c) of the act and afford an 
opportunity for a hearing on a proposal to withdraw approval of such 
application if he finds:
    (1) That the applicant has failed to establish a system for 
maintaining required records, or has repeatedly or deliberately failed 
to maintain such records or to make required reports in accordance with 
a regulation or order under section 512(l)(1) of the act, or the 
applicant has refused to permit access to, or copying, or verification 
of, such records as required by section 512(l)(2) of the act; or
    (2) That on the basis of new information before him evaluated 
together with the evidence before him when the application was approved, 
the methods used in, or the facilities and controls used for, the 
manufacture, processing, and packing of such drug or animal feed are 
inadequate to assure and preserve its identity, strength, quality, and 
purity and were not made adequate within a reasonable time after receipt 
of written notice from the Secretary specifying the matter complained 
of; or
    (3) That on the basis of new information before him, evaluated 
together with the evidence before him when the application was approved, 
the labeling of such drug, based on a fair evaluation of all material 
facts, is false or misleading in any particular and was not corrected 
within a reasonable time after receipt of written notice from the 
Secretary specifying the matter complained of.

[[Page 120]]

    (d) Approval of an application pursuant to section 512(c) of the act 
will be withdrawn on the basis of a request for its withdrawal submitted 
in writing by a person holding an approved new animal drug application 
on the grounds that the drug subject to such application is no longer 
being marketed and information is included in support of this finding, 
provided none of the conditions cited in paragraphs (a), (b), and (c) of 
this section pertain to the subject drug. A written request for such 
withdrawal shall be construed as a waiver of the opportunity for a 
hearing as otherwise provided for in this section. Withdrawal of 
approval of an application under the provisions of this paragraph shall 
be without prejudice.
    (e) On the basis of the withdrawal of approval of an application for 
a new animal drug approved pursuant to section 512(c) of the act, the 
regulation published pursuant to section 512(i) of the act covering the 
conditions of use of such drug as provided for in the application shall 
be revoked.

[40 FR 13825, Mar. 27, 1975, as amended at 50 FR 7517, Feb. 22, 1985; 64 
FR 63204, Nov. 19, 1999]



Sec. 514.116  Notice of withdrawal of approval of application.

    When an approval of an application submitted pursuant to section 512 
of the act is withdrawn by the Commissioner, he will give appropriate 
public notice of such action by publication in the Federal Register.



Sec. 514.117  Adequate and well-controlled studies.

    (a) Purpose. The primary purpose of conducting adequate and well-
controlled studies of a new animal drug is to distinguish the effect of 
the new animal drug from other influences, such as spontaneous change in 
the course of the disease, normal animal production performance, or 
biased observation. One or more adequate and well-controlled studies are 
required to establish, by substantial evidence, that a new animal drug 
is effective. The characteristics described in paragraph (b) of this 
section have been developed over a period of years and are generally 
recognized as the essentials of an adequate and well-controlled study. 
Well controlled, as used in the phrase adequate and well controlled, 
emphasizes an important aspect of adequacy. The Food and Drug 
Administration (FDA) considers these characteristics in determining 
whether a study is adequate and well controlled for purposes of section 
512 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 
360b). Adequate and well-controlled studies, in addition to providing a 
basis for determining whether a new animal drug is effective, may also 
be relied upon to support target animal safety. The report of an 
adequate and well-controlled study should provide sufficient details of 
study design, conduct, and analysis to allow critical evaluation and a 
determination of whether the characteristics of an adequate and well-
controlled study are present.
    (b) Characteristics. An adequate and well-controlled study has the 
following characteristics:
    (1) The protocol for the study (protocol) and the report of the 
study results (study report) must include a clear statement of the study 
objective(s).
    (2) The study is conducted in accordance with an appropriate 
standard of conduct that addresses, among other issues, study conduct, 
study personnel, study facilities, and study documentation. The protocol 
contains a statement acknowledging the applicability of, and intention 
to follow, a standard of conduct acceptable to FDA. The study report 
contains a statement describing adherence to the standard.
    (3) The study is conducted with a new animal drug that is produced 
in accordance with appropriate manufacturing practices, which include, 
but are not necessarily limited to, the manufacture, processing, 
packaging, holding, and labeling of the new animal drug such that the 
critical characteristics of identity, strength, quality, purity, and 
physical form of the new animal drug are known, recorded, and 
reproducible, to permit meaningful evaluations of and comparisons with 
other studies conducted with the new animal drug. The physical form of a 
new animal drug includes the formulation and physical characterization 
(including delivery systems thereof, if any) of the new animal drug as 
presented to the

[[Page 121]]

animal. The protocol and study report must include an identification 
number which can be correlated with the specific formulation and 
production process used to manufacture the new animal drug used in the 
study.
    (4) The study uses a design that permits a valid comparison with one 
or more controls to provide a quantitative evaluation of drug effects. 
The protocol and the study report must describe the precise nature of 
the study design, e.g., duration of treatment periods, whether 
treatments are parallel, sequential, or crossover, and the determination 
of sample size. Within the broad range of studies conducted to support a 
determination of the effectiveness of a new animal drug, certain of the 
controls listed below would be appropriate and preferred depending on 
the study conducted:
    (i) Placebo concurrent control. The new animal drug is compared with 
an inactive preparation designed to resemble the new animal drug as far 
as possible.
    (ii) Untreated concurrent control. The new animal drug is compared 
with the absence of any treatment. The use of this control may be 
appropriate when objective measurements of effectiveness, not subject to 
observer bias, are available.
    (iii) Active treatment concurrent control. The new animal drug is 
compared with known effective therapy. The use of this control is 
appropriate when the use of a placebo control or of an untreated 
concurrent control would unreasonably compromise the welfare of the 
animals. Similarity of the new animal drug and the active control drug 
can mean either that both drugs were effective or that neither was 
effective. The study report should assess the ability of the study to 
have detected a difference between treatments. The evaluation of the 
study should explain why the new animal drugs should be considered 
effective in the study, for example, by reference to results in previous 
placebo-controlled studies of the active control.
    (iv) Historical control. The results of treatment with the new 
animal drug are quantitatively compared with experience historically 
derived from the adequately documented natural history of the disease or 
condition, or with a regimen (therapeutic, diagnostic, prophylactic) 
whose effectiveness is established, in comparable animals. Because 
historical control populations usually cannot be as well assessed with 
respect to pertinent variables as can concurrent control populations, 
historical control designs are usually reserved for special 
circumstances. Examples include studies in which the effect of the new 
animal drug is self-evident or studies of diseases with high and 
predictable mortality, or signs and symptoms of predictable duration or 
severity, or, in the case of prophylaxis, predictable morbidity.
    (5) The study uses a method of selecting animals that provides 
adequate assurances that the animals are suitable for the purposes of 
the study. For example, the animals can reasonably be expected to have 
animal production characteristics typical of the class(es) of animals 
for which the new animal drug is intended, there is adequate assurance 
that the animals have the disease or condition being studied, or, in the 
case of prophylactic agents, evidence of susceptibility and exposure to 
the condition against which prophylaxis is desired has been provided. 
The protocol and the study report describe the method of selecting 
animals for the study.
    (6) The study uses a method to assign a treatment or a control to 
each experimental unit of animals that is random and minimizes bias. 
Experimental units of animals are groups of animals that are comparable 
with respect to pertinent variables such as age, sex, class of animal, 
severity of disease, duration of disease, dietary regimen, level of 
animal production, and use of drugs or therapy other than the new animal 
drug. The protocol and the study report describe the method of 
assignment of animals to an experimental unit to account for pertinent 
variables and method of assignment of a treatment or a control to the 
experimental units. When the effect of such variables is accounted for 
by an appropriate design, and when, within the same animal, effects due 
to the test drug can be obtained free of the effects of such variables, 
the same animal may be used for both the test drug and the

[[Page 122]]

control using the controls set forth in paragraph (b)(4) of this 
section.
    (7) The study uses methods to minimize bias on the part of observers 
and analysts of the data that are adequate to prevent undue influences 
on the results and interpretation of the study data. The protocol and 
study report explain the methods of observation and recording of the 
animal response variables and document the methods, such as ``blinding'' 
or ``masking,'' used in the study for excluding or minimizing bias in 
the observations.
    (8) The study uses methods to assess animal response that are well 
defined and reliable. The protocol and study report describe the methods 
for conducting the study, including any appropriate analytical and 
statistical methods, used to collect and analyze the data resulting from 
the conduct of the study, describe the criteria used to assess response, 
and, when appropriate, justify the selection of the methods to assess 
animal response.
    (9) There is an analysis and evaluation of the results of the study 
in accord with the protocol adequate to assess the effects of the new 
animal drug. The study report evaluates the methods used to conduct, and 
presents and evaluates the results of, the study as to their adequacy to 
assess the effects of the new animal drug. This evaluation of the 
results of the study assesses, among other items, the comparability of 
treatment and control groups with respect to pertinent variables and the 
effects of any interim analyses performed.
    (c) Field studies. (1) Field conditions as used in this section 
refers to conditions which closely approximate the conditions under 
which the new animal drug, if approved, is intended to be applied or 
administered.
    (2) Studies of a new animal drug conducted under field conditions 
shall, consistent with generally recognized scientific principles and 
procedures, use an appropriate control that permits comparison, employ 
procedures to minimize bias, and have the characteristics generally 
described in paragraph (b) of this section. However, because field 
studies are conducted under field conditions, it is recognized that the 
level of control over some study conditions need not or should not be 
the same as the level of control in laboratory studies. While not all 
conditions relating to a field study need to be or should be controlled, 
observations of the conditions under which the new animal drug is tested 
shall be recorded in sufficient detail to permit evaluation of the 
study. Adequate and well-controlled field studies shall balance the need 
to control study conditions with the need to observe the true effect of 
the new animal drug under closely approximated actual use conditions.
    (d) Waiver. The Director of the Center for Veterinary Medicine (the 
Director) may, on the Director's own initiative or on the petition of an 
interested person, waive in whole or in part any of the criteria in 
paragraph (b) of this section with respect to a specific study. A 
petition for a waiver is required to set forth clearly and concisely the 
specific criteria from which waiver is sought, why the criteria are not 
reasonably applicable to the particular study, what alternative 
procedures, if any, are to be, or have been employed, and what results 
have been obtained. The petition is also required to state why the 
studies so conducted will yield, or have yielded, substantial evidence 
of effectiveness, notwithstanding nonconformance with the criteria for 
which waiver is requested.
    (e) Uncontrolled studies. Uncontrolled studies or partially 
controlled studies are not acceptable as the sole basis for the approval 
of claims of effectiveness or target animal safety. Such studies, 
carefully conducted and documented, may provide corroborative support of 
adequate and well-controlled studies regarding effectiveness and may 
yield valuable data regarding safety of the new animal drug. Such 
studies will be considered on their merits in light of the 
characteristics listed here. Isolated case reports, random experience, 
and reports lacking the details which permit scientific evaluation will 
not be considered.

[63 FR 10770, Mar. 5, 1998]

[[Page 123]]



Sec. 514.120  Revocation of order refusing to approve an application
or suspending or withdrawing approval of an application.

    The Commissioner, upon his own initiative or upon request of an 
applicant stating reasonable grounds therefor and if he finds that the 
facts so require, may issue an order approving an application that 
previously has had its approval refused, suspended, or withdrawn.



Sec. 514.121  Service of notices and orders.

    All notices and orders under this subchapter E and section 512 of 
the act pertaining to new animal drug applications shall be served:
    (a) In person by any officer or employee of the Department 
designated by the Commissioner; or
    (b) By mailing the order by certified mail addressed to the 
applicant or respondent at his last known address in the records of the 
Food and Drug Administration.



                      Subpart C_Hearing Procedures



Sec. 514.200  Notice of opportunity for hearing; notice of 
participation and requests for hearing; grant or denial of hearing.

    (a) The notice to the applicant of opportunity for a hearing on a 
proposal by the Commissioner to refuse to approve an application or to 
withdraw the approval of an application will be published in the Federal 
Register together with an explanation of the grounds for the proposed 
action. The notice will describe how to request a hearing. An applicant 
has 30 days after publication of the notice to request a hearing.
    (b) If the applicant fails to request a hearing within the 30-day 
timeframe, the Commissioner, without further notice, will publish a 
final order denying or withdrawing approval of the application.
    (c) If the applicant desires to request a hearing:
    (1) Within 30 days after publication of the notice of opportunity 
for hearing, the applicant must submit to the Division of Dockets 
Management written objections and a request for a hearing in accordance 
with Sec. Sec. 12.20 and 12.22. This request for a hearing must include 
each specific objection to the proposal on which a hearing is requested, 
together with a detailed description and analysis of the factual 
information (including all relevant clinical and other investigational 
data) the applicant will present in support of that objection. A request 
for a hearing may not rest upon mere allegations or denials or general 
descriptions of positions or contentions, but must set forth specific 
reliable evidence showing there is a genuine and substantial issue of 
fact that requires a hearing.
    (2) If the Commissioner determines upon review of the data and 
information submitted in the objections and request for a hearing that a 
hearing is not justified because no genuine and substantial issue of 
fact precludes the refusal to approve the application or the withdrawal 
of approval of the application (for example, the applicant has not 
identified any adequate and well-controlled clinical investigations to 
support the claims of effectiveness), the Commissioner will enter an 
order denying the hearing and stating the final findings and 
conclusions.
    (3) If the Commissioner determines upon review of the data and 
information submitted in the objections and request for a hearing that a 
hearing is justified, the Commissioner will publish a notice setting 
forth the following:
    (i) The regulation or order that is the subject of the hearing;
    (ii) A statement specifying any part of the regulation or order that 
has been stayed by operation of law or in the Commissioner's discretion;
    (iii) The parties to the hearing;
    (iv) The specific issues of fact for resolution at the hearing;
    (v) The presiding officer, or a statement that the presiding officer 
will be designated in a later notice; and
    (vi) The date, time, and place of the prehearing conference, or a 
statement that the date, time, and place will be announced in a later 
notice. However, in the case of a denial of approval, the hearing must 
not occur more than 90 days after expiration of the 30-day time period 
in which to request a hearing, unless the presiding officer and the 
applicant otherwise agree; and in the case

[[Page 124]]

of withdrawal of approval, the hearing will occur as soon as 
practicable.
    (d) The hearing will be open to the public; however, if the 
Commissioner finds that portions of the application which serve as a 
basis for the hearing contain information concerning a method or process 
entitled to protection as a trade secret, the part of the hearing 
involving such portions will not be public, unless the respondent so 
specifies in the request for a hearing.

[81 FR 52997, Aug. 11, 2016]



Sec. 514.201  Procedures for hearings.

    Hearings relating to new animal drugs under section 512(d) and (e) 
of the act shall be governed by part 12 of this chapter.

[64 FR 63204, Nov. 19, 1999]

Subparts D-E [Reserved]



                        Subpart F_Judicial Review



Sec. 514.235  Judicial review.

    (a) The transcript and record shall be certified by the 
Commissioner. In any case in which the Commissioner enters an order 
without a hearing pursuant to Sec. 314.200(g) of this chapter, the 
request(s) for hearing together with the data and information submitted 
and the Commissioner's findings and conclusions shall be included in the 
record certified by the Commissioner.
    (b) Judicial review of an order withdrawing approval of a new drug 
application, whether or not a hearing has been held, may be sought by a 
manufacturer or distributor of an identical, related, or similar drug 
product, as defined in Sec. 310.6 of this chapter, in a United States 
court of appeals pursuant to section 505(h) of the act.

[42 FR 4717, Jan. 25, 1977]



PART 515_MEDICATED FEED MILL LICENSE--Table of Contents



                         Subpart A_Applications

Sec.
515.10 Medicated feed mill license applications.
515.11 Supplemental medicated feed mill license applications.

              Subpart B_Administrative Actions on Licenses

515.20 Approval of medicated feed mill license applications.
515.21 Refusal to approve a medicated feed mill license application.
515.22 Suspension and/or revocation of approval of a medicated feed mill 
          license.
515.23 Voluntary revocation of medicated feed mill license.
515.24 Notice of revocation of a medicated feed mill license.
515.25 Revocation of order refusing to approve a medicated feed mill 
          license application or suspending or revoking a license.
515.26 Services of notices and orders.

                      Subpart C_Hearing Procedures

515.30 Contents of notice of opportunity for a hearing.
515.31 Procedures for hearings.

                        Subpart D_Judicial Review

515.40 Judicial review.

    Authority: 21 U.S.C. 360b, 371.

    Source: 64 FR 63204, Nov. 19, 1999, unless otherwise noted.



                         Subpart A_Applications



Sec. 515.10  Medicated feed mill license applications.

    (a) Medicated feed mill license applications (Forms FDA 3448) may be 
obtained from the Public Health Service, Consolidated Forms and 
Publications Distribution Center, Washington Commerce Center, 3222 
Hubbard Rd., Landover, MD 20785, or electronically from the Center for 
Veterinary Medicine home page at http://www.fda.gov/cvm.
    (b) A completed medicated feed mill license must contain the 
following information:
    (1) The full business name and address of the facility at which the 
manufacturing is to take place.
    (2) The facility's FDA registration number as required by section 
510 of the Federal Food, Drug, and Cosmetic Act (the act).
    (3) The name, title, and signature of the responsible individual or 
individuals for that facility.
    (4) A certification that the animal feeds bearing or containing new 
animal drugs are manufactured and labeled in

[[Page 125]]

accordance with the applicable regulations published under section 
512(i) of the act or in accordance with the index listing published 
under section 572(e)(2) of the act.
    (5) A certification that the methods used in, and the facilities and 
controls used for, manufacturing, processing, packaging, and holding 
such animal feeds conform to current good manufacturing practice as 
described in section 501(a)(2)(B) of the act and in part 225 of this 
chapter.
    (6) A certification that the facility will establish and maintain 
all records required by regulation or order issued under sections 
512(m)(5)(A) or 504(a)(3)(A) of the act, and will permit access to, or 
copying or verification of such records.
    (7) A commitment that current approved or index listed Type B and/or 
Type C medicated feed labeling for each Type B and/or Type C medicated 
feed to be manufactured will be in the possession of the feed 
manufacturing facility prior to receiving the Type A medicated article 
containing such drug.
    (8) A commitment to renew registration every year with FDA as 
required in part 207 of this chapter.
    (c) Applications must be completed, signed, and submitted to the 
Division of Animal Feeds (HFV-220), Center for Veterinary Medicine, Food 
and Drug Administration, 7500 Standish Pl., Rockville, MD 20855.
    (d) Applications that are facially deficient will be returned to the 
applicant. All reasons for the return of the application will be made 
known to the applicant.
    (e) Upon approval, the original copy of the application will be 
signed by an authorized employee of FDA designated by the Commissioner 
of Food and Drugs, and a copy will be returned to the applicant.

[64 FR 63204, Nov. 19, 1999, as amended at 72 FR 69121, Dec. 6, 2007; 81 
FR 60221, Aug. 31, 2016]



Sec. 515.11  Supplemental medicated feed mill license applications.

    (a) After approval of a medicated feed mill license application to 
manufacture animal feed, a supplemental application shall be submitted 
for a change in ownership and/or a change in mailing address of the 
facility site.
    (b) Each supplemental application should be accompanied by a fully 
completed Form FDA 3448 and include an explanation of the change.
    (c) Within 30 working days after a supplemental application has been 
filed, if the Commissioner of Food and Drugs determines that the 
application provides adequate information respecting the change in 
ownership and/or postal address of the facility site, then an authorized 
employee of the Food and Drug Administration designated by the 
Commissioner shall notify the applicant that it is approved by signing 
and mailing to the applicant a copy of the Form FDA 3448. Supplemental 
applications that do not provide adequate information shall be returned 
to the applicant and all reasons for the return of the application shall 
be made known to the applicant.



              Subpart B_Administrative Actions on Licenses



Sec. 515.20  Approval of medicated feed mill license applications.

    Within 90 days after an application has been filed under Sec. 
515.10, if the Commissioner of Food and Drugs (the Commissioner) 
determines that none of the grounds for denying approval specified in 
section 512(m)(3) of the Federal Food, Drug, and Cosmetic Act (the act) 
applies, an authorized employee of the Food and Drug Administration 
designated by the Commissioner shall notify the applicant that it is 
approved by signing and mailing to the applicant a copy of the Form FDA 
3448.



Sec. 515.21  Refusal to approve a medicated feed mill license 
application.

    (a) The Commissioner of Food and Drugs (the Commissioner) shall 
within 90 days, or such additional period as may be agreed upon by the 
Commissioner and the applicant, after the filing of an application under 
Sec. 515.10, inform the applicant in writing of his/her intention to 
issue a notice of opportunity for a hearing on a proposal to refuse to 
approve the application, if the Commissioner determines upon the basis 
of the application, on the basis of a preapproval inspection, or upon 
the

[[Page 126]]

basis of any other information before him that:
    (1) The application is incomplete, false, or misleading in any 
particular; or
    (2) The methods used in and the facilities and controls used for the 
manufacturing, processing, and packaging of such animal feed are not 
adequate to preserve the identity, strength, quality, and purity of the 
new animal drug therein; or
    (3) The facility manufactures animal feeds bearing or containing new 
animal drugs in a manner that does not accord with the specifications 
for manufacture or labels animal feeds bearing or containing new animal 
drugs in a manner that does not accord with the conditions or 
indications of use that are published under section 512(i) or 572(e)(2) 
of the act.
    (b) The Commissioner, as provided in Sec. 515.30, shall 
expeditiously notify the applicant of an opportunity for a hearing on 
the question of whether such application is approvable, unless by the 
30th day following the date of issuance of the letter informing the 
applicant of the intention to issue a notice of opportunity for a 
hearing the applicant:
    (1) Withdraws the application; or
    (2) Waives the opportunity for a hearing; or
    (3) Agrees with the Commissioner on an additional period to precede 
issuance of such notice of hearing.

[64 FR 63204, Nov. 19, 1999, as amended at 72 FR 69121, Dec. 6, 2007]



Sec. 515.22  Suspension and/or revocation of approval of a medicated
feed mill license.

    (a) The Secretary of Health and Human Services may suspend a 
medicated feed mill license approved under section 512(m)(2) of the 
Federal Food, Drug, and Cosmetic Act (the act) and give the person 
holding the medicated feed mill license application prompt notice of 
this action and afford the applicant the opportunity for an expedited 
hearing on a finding that there is an imminent hazard to the health of 
man or of the animals for which such animal feed is intended.
    (b) The Commissioner of Food and Drugs (the Commissioner) shall 
notify in writing the person holding an application approved under 
section 512(m)(2) of the act and afford an opportunity for a hearing on 
a proposal to revoke approval of such application if the Commissioner 
finds:
    (1) That the application contains any untrue statement of a material 
fact; or
    (2) That the applicant has made any changes that would cause the 
application to contain any untrue statements of material fact or that 
would affect the safety or effectiveness of the animal feeds 
manufactured at the facility unless the applicant has supplemented the 
application by filing a supplemental application under Sec. 515.11.
    (c) The Commissioner may notify in writing the person holding an 
application approved under section 512(m)(2) of the act and afford an 
opportunity for a hearing on a proposal to revoke approval of such 
application if the Commissioner finds:
    (1) That the applicant has failed to establish a system for 
maintaining required records, or has repeatedly or deliberately failed 
to maintain such records or to make required reports in accordance with 
a regulation or order under sections 512(m)(5)(A) or 504(a)(3)(A) of the 
act, or the applicant has refused to permit access to, or copying, or 
verification of, such records as required by sections 512(m)(5)(B) or 
504(a)(3)(B) of the act; or
    (2) That on the basis of new information before him, evaluated 
together with the evidence before him when such license was issued, the 
methods used in, or the facilities and controls used for, the 
manufacture, processing, packing, and holding of such animal feed are 
inadequate to assure and preserve the identity, strength, quality, and 
purity of the new animal drug therein, and were not made adequate within 
a reasonable time after receipt of written notice from the Commissioner 
specifying the matter complained of; or
    (3) That on the basis of new information before him, evaluated 
together with the evidence before him when such license was issued, the 
labeling of any animal feeds, based on a fair evaluation of all material 
facts, is false or misleading in any particular and was not corrected 
within a reasonable time after receipt of written notice from the

[[Page 127]]

Commissioner specifying the matter complained of; or
    (4) That on the basis of new information before him, evaluated 
together with the evidence before him when such license was issued, the 
facility has manufactured, processed, packed, or held animal feed 
bearing or containing a new animal drug adulterated under section 
501(a)(6) of the act, and the facility did not discontinue the 
manufacture, processing, packing, or holding of such animal feed within 
a reasonable time after receipt of written notice from the Commissioner 
specifying the matter complained of.



Sec. 515.23  Voluntary revocation of medicated feed mill license.

    A license issued under section 512(m)(2) of the Federal Food, Drug, 
and Cosmetic Act (the act) will be revoked on the basis of a request for 
its revocation submitted in writing by a responsible individual holding 
such license on the grounds that the facility no longer manufactures any 
animal feed covered under Sec. 558.4(b) of this chapter. A written 
request for such revocation shall be construed as a waiver of the 
opportunity for a hearing as otherwise provided for in this section. 
Revocation of approval of a medicated feed mill license under the 
provisions of this paragraph shall be without prejudice.



Sec. 515.24  Notice of revocation of a medicated feed mill license.

    When a license approved under section 512 of the Federal Food, Drug, 
and Cosmetic Act (the act) is revoked by the Commissioner of Food and 
Drugs (the Commissioner), the Commissioner will give appropriate public 
notice of such action by publication in the Federal Register.



Sec. 515.25  Revocation of order refusing to approve a medicated feed
mill license application or suspending or revoking a license.

    The Commissioner of Food and Drugs (the Commissioner), upon his/her 
own initiative or upon request of an applicant stating reasonable 
grounds therefor and if the Commissioner finds that the facts so 
require, may issue an order approving a medicated feed mill license 
application that previously has had its approval refused, suspended, or 
revoked.



Sec. 515.26  Services of notices and orders.

    All notices and orders under this part 515 and section 512 of the 
Federal Food, Drug, and Cosmetic Act (the act) pertaining to medicated 
feed mill licenses shall be served:
    (a) In person by any officer or employee of the Department of Health 
and Human Services designated by the Commissioner of Food and Drugs; or
    (b) By mailing the order by certified mail addressed to the 
applicant or respondent at the applicant or respondent's last known 
address in the records of the Food and Drug Administration.



                      Subpart C_Hearing Procedures



Sec. 515.30  Contents of notice of opportunity for a hearing.

    (a) The notice to the applicant of opportunity for a hearing on a 
proposal by the Commissioner of Food and Drugs (the Commissioner) to 
refuse to approve a medicated feed mill license application or to revoke 
the approval of a medicated feed mill license will specify the grounds 
upon which the Commissioner proposes to issue this order. On request of 
the applicant, the Commissioner will explain the reasons for the action. 
The notice of opportunity for a hearing will be published in the Federal 
Register and will specify that the applicant has 30 days after issuance 
of the notice within which the Commissioner is required to file a 
written appearance electing whether:
    (1) To avail himself of the opportunity for a hearing; or
    (2) Not to avail himself of the opportunity for a hearing.
    (b) If the applicant fails to file a written appearance in answer to 
the notice of opportunity for hearing, this failure will be construed as 
an election not to avail himself of the opportunity for the hearing, and 
the Commissioner without further notice may enter a final order.
    (c) If the applicant elects to avail himself of the opportunity for 
a hearing, the applicant is required to file a written appearance 
requesting the

[[Page 128]]

hearing within 30 days after the publication of the notice, giving the 
reason why the application should not be refused or the medicated feed 
mill license should not be revoked, together with a well-organized and 
full-factual analysis of the information the applicant is prepared to 
prove in support of his opposition to the Commissioner's proposal. A 
request for a hearing may not rest upon mere allegations or denials, but 
must set forth specific facts showing there is a genuine and substantial 
issue of fact that requires a hearing. When it clearly appears from the 
information in the application and from the reasons and factual analysis 
in the request for the hearing that no genuine and substantial issue of 
fact precludes the refusal to approve the application or the revocation 
of approval of the application, the Commissioner will enter an order on 
this information, stating his/her findings and conclusions. If a hearing 
is requested and is justified by the applicant's response to the notice 
of opportunity for a hearing, the issues will be defined, an 
Administrative Law Judge will be named, and the Judge shall issue a 
written notice of the time and place at which the hearing will commence. 
In the case of denial of approval, such time shall be not more than 90 
days after the expiration of such 30 days unless the Administrative Law 
Judge and the applicant otherwise agree; and, in the case of withdrawal 
of approval, such time shall be as soon as practicable.
    (d) The hearing will be open to the public; however, if the 
Commissioner finds that portions of the application which serve as a 
basis for the hearing contain information concerning a method or process 
entitled to protection as a trade secret, the part of the hearing 
involving such portions will not be public, unless the respondent so 
specifies in the appearance.



Sec. 515.31  Procedures for hearings.

    Hearings relating to new animal drugs under section 512(m)(3) and 
(m)(4) of the Federal Food, Drug, and Cosmetic Act (the act) shall be 
governed by part 12 of this chapter.



                        Subpart D_Judicial Review



Sec. 515.40  Judicial review.

    The transcript and record shall be certified by the Commissioner of 
Food and Drugs (the Commissioner). In any case in which the Commissioner 
enters an order without a hearing under Sec. 314.200(g) of this 
chapter, the request(s) for hearing together with the data and 
information submitted and the Commissioner's findings and conclusions 
shall be included in the record certified by the Commissioner.



PART 516_NEW ANIMAL DRUGS FOR MINOR USE AND MINOR SPECIES--
Table of Contents



                      Subpart A_General Provisions

Sec.
516.1 Scope.
516.2 Purpose.
516.3 Definitions.

  Subpart B_Designation of a Minor Use or Minor Species New Animal Drug

516.11 Scope of this subpart.
516.12 Purpose.
516.13 Definitions.
516.14 Submission of requests for designation.
516.16 Eligibility to request designation.
516.20 Content and format of a request for MUMS-drug designation.
516.21 Documentation of minor use status.
516.22 Permanent-resident U.S. agent for foreign sponsor.
516.23 Timing of requests for MUMS-drug designation.
516.24 Granting MUMS-drug designation.
516.25 Refusal to grant MUMS-drug designation.
516.26 Amendment to MUMS-drug designation.
516.27 Change in sponsorship.
516.28 Publication of MUMS-drug designations.
516.29 Termination of MUMS-drug designation.
516.30 Annual reports for a MUMS-designated drug.
516.31 Scope of MUMS-drug exclusive marketing rights.
516.34 FDA recognition of exclusive marketing rights.
516.36 Insufficient quantities of MUMS-designated drugs.

[[Page 129]]

516.52 Availability for public disclosure of data and information in 
          requests.

  Subpart C_Index of Legally Marketed Unapproved New Animal Drugs for 
                              Minor Species

516.111 Scope of this subpart.
516.115 Definitions.
516.117 Submission of correspondence under this subpart.
516.119 Permanent-resident U.S. agent for foreign requestors and 
          holders.
516.121 Meetings.
516.123 Informal conferences regarding agency administrative actions.
516.125 Investigational use of minor species new animal drugs to support 
          indexing.
516.129 Content and format of a request for determination of eligibility 
          for indexing.
516.131 Refuse to file a request for determination of eligibility for 
          indexing.
516.133 Denying a request for determination of eligibility for indexing.
516.135 Granting a request for determination of eligibility for 
          indexing.
516.137 Notification of decision regarding eligibility for indexing.
516.141 Qualified expert panels.
516.143 Written report.
516.145 Content and format of a request for addition to the index.
516.147 Refuse to file a request for addition to the index.
516.149 Denying a request for addition to the index.
516.151 Granting a request for addition to the index.
516.153 Notification of decision regarding index listing.
516.155 Labeling of indexed drugs.
516.157 Publication of the index and content of an index listing.
516.161 Modifications to indexed drugs.
516.163 Change in ownership of an index file.
516.165 Records and reports.
516.167 Removal from the index.
516.171 Confidentiality of data and information in an index file.

Subpart D [Reserved]

  Subpart E_Conditionally Approved New Animal Drugs For Minor Use and 
                              Minor Species

516.812 Enrofloxacin.
516.1684 Paclitaxel.
516.2065 Rabacfosadine.

    Authority: 21 U.S.C. 360ccc-1, 360ccc-2, 371.

    Source: 72 FR 41017, July 26, 2007, unless otherwise noted.



                      Subpart A_General Provisions



Sec. 516.1  Scope.

    (a) This part implements section 573 of the Federal Food, Drug, and 
Cosmetic Act (the act) (21 U.S.C. 360ccc-2) and contains the following 
subparts:
    (1) Subpart A--General Provisions.
    (2) Subpart B--Designation of a Minor Use or Minor Species New 
Animal Drug.
    (3) Subpart C [Reserved]
    (4) Subpart D [Reserved]
    (b) References in this part to regulatory sections of the Code of 
Federal Regulations are to Chapter I of Title 21, unless otherwise 
noted.



Sec. 516.2  Purpose.

    This part establishes standards and procedures for implementing 
section 573 of the act, including designation of minor use or minor 
species new animal drugs and associated exclusive marketing rights.



Sec. 516.3  Definitions.

    (a) The definitions and interpretations contained in section 201 of 
the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 321) apply 
to those terms when used in this part.
    (b) The following definitions of terms apply to all subparts of part 
516:
    Active moiety means the molecule or ion, excluding those appended 
portions of the molecule that cause the drug to be an ester, salt 
(including a salt with hydrogen or coordination bonds), or other 
noncovalent derivative (such as a complex, chelate, or clathrate) of the 
molecule, responsible for the pharmacological action of the drug 
substance.
    Functionally superior means that a drug has been shown to provide a 
significant therapeutic or physiologic advantage over that provided by a 
conditionally-approved or approved MUMS drug, that is otherwise the same 
drug, in one or more of the following ways:
    (i) The drug has been shown to be more effective, as assessed by 
effect on a clinically meaningful endpoint in adequate and well-
controlled clinical trials, than a conditionally approved or approved 
MUMS drug, that is otherwise the same drug. Generally, this would 
represent the same kind of evidence needed to support a comparative

[[Page 130]]

effectiveness claim for two different drugs; in most cases, direct 
comparative clinical trials will be necessary; or
    (ii) The drug has been shown to be safer than a conditionally-
approved or approved MUMS drug, that is otherwise the same drug, in a 
substantial portion of the target population, for example, by the 
elimination of an ingredient or contaminant that is associated with 
relatively frequent adverse effects. In some cases, direct comparative 
clinical trials will be necessary.
    Infrequently, as used in the minor use definition, means a disease 
or condition that is uncommon or that occurs only sporadically on an 
annualized basis.
    Limited geographical areas, as used in the minor use definition, 
means regions of the United States distinguished by physical, chemical, 
or biological factors that limit the distribution of a disease or 
condition.
    Major species means cattle, horses, swine, chickens, turkeys, dogs, 
and cats.
    Minor species means animals, other than humans, that are not major 
species.
    Minor use means the intended use of a drug in a major species for an 
indication that occurs infrequently and in only a small number of 
animals or in limited geographical areas and in only a small number of 
animals annually.
    MUMS drug means a new animal drug, as defined in section 201 of the 
act, intended for a minor use or for use in a minor species.
    Same dosage form means the same as one of the dosage form categories 
specified in the following parts of this chapter:
    (i) Part 520: Oral dosage form new animal drugs (excluding use in 
animal feeds as specified in part 558 of this chapter).
    (ii) Part 522: Implantation or injectable dosage form new animal 
drugs.
    (iii) Part 524: Ophthalmic and topical dosage form new animal drugs.
    (iv) Part 526: Intramammary dosage forms.
    (v) Part 529: Certain other dosage form new animal drugs.
    (vi) Part 558: New animal drugs for use in animal feeds.
    Same drug means a MUMS drug for which designation, indexing, or 
conditional approval is sought that meets the following criteria:
    (i) If it is a MUMS drug composed of small molecules and contains 
the same active moiety as a prior designated, conditionally-approved, or 
approved MUMS drug, even if the particular ester or salt (including a 
salt with hydrogen or coordination bonds) or other noncovalent 
derivative such as a complex, chelate or clathrate is not the same, it 
is considered the same drug; except that, if the prior MUMS drug is 
conditionally approved or approved and the second MUMS drug is shown to 
be functionally superior to the conditionally approved or approved MUMS 
drug for the same intended use, it is not considered the same drug.
    (ii) If it is a MUMS drug composed of large molecules 
(macromolecules) and contains the same principal molecular structural 
features (but not necessarily all of the same structural features) as a 
prior designated, conditionally approved, or approved MUMS drug, it is 
considered the same drug; except that, if the prior MUMS drug is 
conditionally approved or approved and the second MUMS drug is shown to 
be functionally superior to the conditionally approved or approved MUMS 
drug for the same intended use, it is not considered the same drug. This 
criterion will be applied as follows to different kinds of 
macromolecules:
    (A) Two protein drugs would be considered the same if the only 
differences in structure between them were due to post-translational 
events or infidelity of translation or transcription or were minor 
differences in amino acid sequence; other potentially important 
differences, such as different glycosylation patterns or different 
tertiary structures, would not cause the drugs to be considered 
different unless the subsequent drug is shown to be functionally 
superior.
    (B) Two polysaccharide drugs would be considered the same if they 
had identical saccharide repeating units, even if the number of units 
were to vary and even if there were postpolymerization modifications, 
unless the subsequent drug is shown to be functionally superior.

[[Page 131]]

    (C) Two polynucleotide drugs consisting of two or more distinct 
nucleotides would be considered the same if they had an identical 
sequence of purine and pyrimidine bases (or their derivatives) bound to 
an identical sugar backbone (ribose, deoxyribose, or modifications of 
these sugars), unless the subsequent drug is shown to be functionally 
superior.
    (D) Closely related, complex partly definable drugs with similar 
pharmacologic intent would be considered the same unless the subsequent 
drug is shown to be functionally superior.
    Same intended use means an intended use of a MUMS drug, for which 
designation, indexing, or conditional approval is sought, that is 
determined to be the same as (or not different from) a previously 
designated, conditionally approved, or approved intended use of a MUMS 
drug. Same intended use is established by comparing two intended uses 
and not by simply comparing the specific language by means of which the 
intent is established in labeling in accordance with the following 
criteria:
    (i) Two intended uses are considered the same if one of the intended 
uses falls completely within the scope of the other.
    (ii) For intended uses associated with diseases or conditions with 
multiple causative organisms, two intended uses are not considered the 
same when they involve different causative organisms or different 
subsets of causative organisms of that disease or condition when the 
causative organisms involved can reliably be shown to be clinically 
significant causes of the disease or condition.
    (iii) Two intended uses of a drug are not considered the same if 
they involve different intended species or different definable 
subpopulations (including ``production classes'') of a species.
    Small number of animals means equal to or less than 50,000 horses; 
70,000 dogs; 120,000 cats; 310,000 cattle; 1,450,000 pigs; 14,000,000 
turkeys; and 72,000,000 chickens.
    Sponsor means the person requesting designation for a MUMS drug who 
must be the real party in interest of the development and the intended 
or actual production and sales of such drug (in this context, the 
sponsor may be an individual, partnership, organization, or 
association). Sponsor also means the person responsible for an 
investigation of a new animal drug (in this context, the sponsor may be 
an individual, partnership, corporation, or Government agency or may be 
a manufacturer, scientific institution, or an investigator regularly and 
lawfully engaged in the investigation of new animal drugs). Sponsor also 
means the person submitting or receiving approval for a new animal drug 
application (in this context, the sponsor may be an individual, 
partnership, organization, or association). In all contexts, the sponsor 
is responsible for compliance with applicable provisions of the act and 
regulations.

[72 FR 41017, July 26, 2007, as amended at 74 FR 43050, Aug. 25, 2009; 
75 FR 69588, Nov. 15, 2010]



  Subpart B_Designation of a Minor Use or Minor Species New Animal Drug



Sec. 516.11  Scope of this subpart.

    This subpart implements section 573 of the act. Specifically, this 
subpart sets forth the procedures and requirements for submissions to 
FDA of requests for designation of a new animal drug for a minor use or 
a minor species.



Sec. 516.12  Purpose.

    This subpart establishes standards and procedures for determining 
eligibility for designation and the associated incentives and benefits 
described in section 573 of the act, including a 7-year period of 
exclusive marketing rights.



Sec. 516.13  Definitions.

    The following definitions of terms apply only in the context of 
subpart B of this part:
    Director means the Director of the Office of Minor Use and Minor 
Species Animal Drug Development of the FDA Center for Veterinary 
Medicine.
    Intended use means the intended treatment, control or prevention of 
a disease or condition, or the intention to affect the structure or 
function of

[[Page 132]]

the body of animals within an identified species, subpopulation of a 
species, or collection of species.
    MUMS-designated drug means a new animal drug, as defined in section 
201 of the act, intended for a minor use or for use in a minor species 
that has been designated under section 573 of the act.
    MUMS-drug exclusive marketing rights or exclusive marketing rights 
means that, effective on the date of FDA conditional approval or 
approval as stated in the approval letter of an application for a MUMS-
designated drug, no conditional approval or approval will be given to a 
subsequent application for the same drug, in the same dosage form, for 
the same intended use for 7 years, except as otherwise provided by law 
or in this subpart.



Sec. 516.14  Submission of requests for designation.

    All correspondence relating to a request for designation of a MUMS 
drug must be addressed to the Director of the Office of Minor Use and 
Minor Species Animal Drug Development. Submissions not including all 
elements specified in Sec. 516.20 will be returned to the sponsor 
without review.



Sec. 516.16  Eligibility to request designation.

    The person requesting designation must be the sponsor and the real 
party in interest of the development and the intended or actual 
production and sales of the drug or the permanent-resident U.S. agent 
for such a sponsor.



Sec. 516.20  Content and format of a request for MUMS-drug designation.

    (a) A sponsor that submits a request for designation of a new animal 
drug intended for a minor use or minor species must submit each request 
in the form and containing the information required in paragraph (b) of 
this section. While a request for designation may involve multiple 
intended uses, each request for designation must constitute a separate 
submission. A sponsor may request MUMS-drug designation of a previously 
unapproved drug, or a new intended use or dosage form for an already 
conditionally approved or approved drug. Only one sponsor may receive 
MUMS-drug designation of the same drug, in the same dosage form, for the 
same intended use.
    (b) A sponsor must submit two copies of a completed, dated, and 
signed request for designation that contains the following information:
    (1) A request for designation of a new animal drug for a minor use 
or use in a minor species, which must be specific.
    (2) The name and address of the sponsor; the name of the sponsor's 
primary contact person and/or permanent-resident U.S. agent including 
title, address, and telephone number; the established name (and 
proprietary name, if any) of the active pharmaceutical ingredient of the 
drug; and the name and address of the source of the active 
pharmaceutical ingredient of the drug.
    (3) A description of the proposed intended use for which the drug is 
being or will be investigated.
    (4) A description of the drug and dosage form.
    (5) A discussion of the scientific rationale for the intended use of 
the drug; specific reference, including date(s) of submission, to all 
data from nonclinical laboratory studies, clinical investigations, 
copies of pertinent unpublished and published papers, and other relevant 
data that are available to the sponsor, whether positive, negative, or 
inconclusive.
    (6) A specific description of the product development plan for the 
drug, its dosage form, and its intended use.
    (7) If the drug is intended for a minor use in a major species, 
documentation in accordance with Sec. 516.21, with appended 
authoritative references, to demonstrate that such use is a minor use.
    (8) A statement that the sponsor submitting the request is the real 
party in interest of the development and the intended or actual 
production and sales of the product.
    (9) A statement that the sponsor acknowledges that, upon granting a 
request for MUMS designation, FDA will make information regarding the 
designation publicly available as specified in Sec. 516.28.

[72 FR 41017, July 26, 2007, as amended at 75 FR 69588, Nov. 15, 2010; 
77 FR 18685, Mar. 28, 2012]

[[Page 133]]



Sec. 516.21  Documentation of minor use status.

    So that FDA can determine whether a drug qualifies for MUMS-drug 
designation as a minor use in a major species under section 573 of the 
act, the sponsor shall include in its request to FDA for MUMS-drug 
designation under Sec. 516.20 documentation demonstrating that the use 
is limited to a small number of animals (annualized). This documentation 
must include the following information:
    (a) The estimated total number of animals to which the drug could 
potentially be administered on an annual basis for the treatment, 
control, or prevention of the disease or condition for which the drug is 
being developed, including animals administered the drug as part of herd 
or flock treatment, together with a list of the sources (including dates 
of information provided and literature citations) for the estimate.
    (b) The estimated total number of animals referred to in paragraph 
(a) of this section may be further reduced to only a subset of the 
estimated total number of animals if administration of the drug is only 
medically justified for this subset. To establish this, requestors must 
demonstrate that administration of the drug to animals subject to the 
disease or condition for which the drug is being developed other than 
the subset is not medically justified. The sponsor must also include a 
list of the sources (including dates of information provided and 
literature citations) for the justification that administration of the 
drug to animals other than the targeted subset is medically 
inappropriate.

[72 FR 41017, July 26, 2007, as amended at 74 FR 43050, Aug. 25, 2009]



Sec. 516.22  Permanent-resident U.S. agent for foreign sponsor.

    Every foreign sponsor that seeks MUMS-drug designation shall name a 
permanent resident of the United States as the sponsor's agent upon whom 
service of all processes, notices, orders, decisions, requirements, and 
other communications may be made on behalf of the sponsor. Notifications 
of changes in such agents or changes of address of agents should 
preferably be provided in advance, but not later than 60 days after the 
effective date of such changes. The permanent-resident U.S. agent may be 
an individual, firm, or domestic corporation and may represent any 
number of sponsors. The name and address of the permanent-resident U.S. 
agent shall be provided to the Director of the Office of Minor Use and 
Minor Species Animal Drug Development.



Sec. 516.23  Timing of requests for MUMS-drug designation.

    A sponsor may request MUMS-drug designation at any time in the drug 
development process prior to the submission of an application for either 
conditional approval or approval of the MUMS drug for which designation 
is being requested.



Sec. 516.24  Granting MUMS-drug designation.

    (a) FDA may grant the request for MUMS-drug designation if none of 
the reasons described in Sec. 516.25 for refusal to grant such a 
request apply.
    (b) When a request for MUMS-drug designation is granted, FDA will 
notify the sponsor in writing and will give public notice of the MUMS-
drug designation in accordance with Sec. 516.28.



Sec. 516.25  Refusal to grant MUMS-drug designation.

    (a) FDA will refuse to grant a request for MUMS-drug designation if 
any of the following reasons apply:
    (1) The drug is not intended for use in a minor species or FDA 
determines that there is insufficient evidence to demonstrate that the 
drug is intended for a minor use in a major species.
    (2) The drug is the same drug in the same dosage form for the same 
intended use as one that already has a MUMS-drug designation but has not 
yet been conditionally approved or approved.
    (3) The drug is the same drug in the same dosage form for the same 
intended use as one that is already conditionally approved or approved. 
A drug that FDA has found to be functionally superior is not considered 
the same drug as an already conditionally approved or approved drug even 
if it is

[[Page 134]]

otherwise the same drug in the same dosage form for the same intended 
use.
    (4) The sponsor has failed to provide:
    (i) A credible scientific rationale in support of the intended use,
    (ii) Sufficient information about the product development plan for 
the drug, its dosage form, and its intended use to establish that 
adherence to the plan can lead to successful drug development in a 
timely manner, and
    (iii) Any other information required under Sec. 516.20.
    (b) FDA may refuse to grant a request for MUMS-drug designation if 
the request for designation contains an untrue statement of material 
fact or omits material information.



Sec. 516.26  Amendment to MUMS-drug designation.

    (a) At any time prior to conditional approval or approval of an 
application for a MUMS-designated drug, the sponsor may apply for an 
amendment to the designated intended use if the proposed change is due 
to new and unexpected findings in research on the drug, information 
arising from FDA recommendations, or other unforeseen developments.
    (b) FDA will grant the amendment if it finds:
    (1) That the initial designation request was made in good faith;
    (2) That the amendment is intended to make the MUMS-drug designated 
intended use conform to the results of new and unexpected findings in 
research on the drug, information arising from FDA recommendations, or 
other unforeseen developments; and
    (3) In the case of a minor use, that as of the date of the 
submission of the amendment request, the amendment would not result in 
the intended use of the drug no longer being considered a minor use.



Sec. 516.27  Change in sponsorship.

    (a) A sponsor may transfer sponsorship of a MUMS-designated drug to 
another person. A change of sponsorship will also transfer the 
designation status of the drug which will remain in effect for the new 
sponsor subject to the same conditions applicable to the former sponsor 
provided that at the time of a potential transfer, the new and former 
sponsors submit the following information in writing and obtain 
permission from FDA:
    (1) The former sponsor shall submit a letter to FDA that documents 
the transfer of sponsorship of the MUMS-designated drug. This letter 
shall specify the date of the transfer. The former sponsor shall also 
certify in writing to FDA that a complete copy of the request for MUMS-
drug designation, including any amendments to the request, and 
correspondence relevant to the MUMS-drug designation, has been provided 
to the new sponsor.
    (2) The new sponsor shall submit a letter or other document 
containing the following information:
    (i) A statement accepting the MUMS-drug designated file or 
application;
    (ii) The date that the change in sponsorship is intended to be 
effective;
    (iii) A statement that the new sponsor has a complete copy of the 
request for MUMS-drug designation, including any amendments to the 
request and any correspondence relevant to the MUMS-drug designation;
    (iv) A statement that the new sponsor understands and accepts the 
responsibilities of a sponsor of a MUMS-designated drug established 
elsewhere in this subpart;
    (v) The name and address of a new primary contact person or 
permanent resident U.S. agent; and
    (vi) Evidence that the new sponsor is capable of actively pursuing 
approval with due diligence.
    (b) No sponsor may relieve itself of responsibilities under the act 
or under this subpart by assigning rights to another person without:
    (1) Assuring that the new sponsor will carry out such 
responsibilities; and
    (2) Obtaining prior permission from FDA.



Sec. 516.28  Publication of MUMS-drug designations.

    FDA will periodically update a publicly available list of MUMS-
designated drugs. This list will be placed on file at the FDA Division 
of Dockets Management, and will contain the following information for 
each MUMS-designated drug:

[[Page 135]]

    (a) The name and address of the sponsor;
    (b) The established name and trade name, if any, of the drug;
    (c) The dosage form of the drug;
    (d) The species and the proposed intended use for which MUMS-drug 
designation was granted; and
    (e) The date designation was granted.



Sec. 516.29  Termination of MUMS-drug designation.

    (a) The sponsor of a MUMS-designated drug must notify FDA of any 
decision to discontinue active pursuit of conditional approval or 
approval of such MUMS drug. FDA must terminate the designation upon such 
notification.
    (b) A conditionally-approved or approved MUMS-designated drug 
sponsor must notify FDA at least 1 year before it intends to discontinue 
the manufacture of such MUMS drug. FDA must terminate designation upon 
such notification.
    (c) MUMS designation shall terminate upon the expiration of any 
applicable period of exclusive marketing rights under this subpart.
    (d) FDA may terminate designation if it independently determines 
that the sponsor is not actively pursuing conditional approval or 
approval with due diligence. At a minimum, due diligence must be 
demonstrated by:
    (1) Submission of annual progress reports in a timely manner in 
accordance with Sec. 516.30 that demonstrate that the sponsor is 
progressing in accordance with the drug development plan submitted to 
the agency under Sec. 516.20 and
    (2) Compliance with all applicable requirements of part 511 of this 
chapter.
    (e) Designation of a conditionally approved or approved MUMS-
designated drug and the associated exclusive marketing rights may be 
terminated if the sponsor is unable to provide sufficient quantities of 
the drug to meet the needs for which it is designated.
    (f) FDA may also terminate MUMS-drug designation for any drug if the 
agency finds that:
    (1) The request for designation contained an untrue statement of 
material fact; or
    (2) The request for designation omitted material information 
required by this subpart; or
    (3) FDA subsequently finds that the drug in fact had not been 
eligible for MUMS-drug designation at the time of submission of the 
request;
    (4) The same drug, in the same dosage form, for the same intended 
use becomes conditionally approved or approved for another sponsor; or
    (5) FDA withdraws the conditional approval or approval of the 
application for the new animal drug.
    (g) For a conditionally approved or approved drug, termination of 
MUMS-drug designation also terminates the sponsor's exclusive marketing 
rights for the drug but does not withdraw the conditional approval or 
approval of the drug's application.
    (h) Where a drug has been MUMS-designated for a minor use in a major 
species, its designation will not be terminated on the grounds that the 
number of animals to which the drug could potentially be administered on 
an annual basis for the treatment, control, or prevention of the disease 
or condition for which the drug is being developed, including animals 
administered the drug as part of herd or flock treatment, subsequently 
increases.
    (i) When a MUMS-drug designation is terminated, FDA will notify the 
sponsor in writing and will give public notice of the termination of the 
MUMS-drug designation.



Sec. 516.30  Annual reports for a MUMS-designated drug.

    Within 14 months after the date on which a MUMS drug is granted 
designation and annually thereafter until approval, the sponsor of a 
MUMS-designated drug shall submit a brief progress report on the drug to 
the investigational new animal drug file addressed to the Director of 
the Office of Minor Use and Minor Species Animal Drug Development that 
includes the following information:
    (a) A short account of the progress of drug development including a 
description of studies initiated, ongoing, and completed, and a short 
summary of the status or results of such studies;
    (b) A description of the investigational plan for the coming year, 
as well as any anticipated difficulties in development, testing, and 
marketing; and

[[Page 136]]

    (c) A brief discussion of any changes that may affect the MUMS-
designated drug status of the product. For example, situations in which 
testing data demonstrate that the proposed intended use is inappropriate 
due to unexpected issues of safety or effectiveness.



Sec. 516.31  Scope of MUMS-drug exclusive marketing rights.

    (a) After conditional approval or approval of an application for a 
MUMS-designated drug in the dosage form and for the intended use for 
which MUMS-drug designation has been granted, FDA will not conditionally 
approve or approve another application or abbreviated application for 
the same drug in the same dosage form for the same intended use before 
the expiration of 7 years after the date of conditional approval or 
approval as stated in the approval letter from FDA, except that such an 
application can be conditionally approved or approved sooner if, and at 
such time as, any of the following occurs:
    (1) FDA terminates the MUMS-drug designation and associated 
exclusive marketing rights under Sec. 516.29; or
    (2) FDA withdraws the conditional approval or approval of the 
application for the drug for any reason; or
    (3) The sponsor with exclusive marketing rights provides written 
consent to FDA to conditionally approve or approve another application 
before the expiration of 7 years; or
    (4) The sponsor fails to assure a sufficient quantity of the drug in 
accordance with section 573 of the act and Sec. 516.36.
    (b) If an application for a MUMS drug cannot be approved until the 
expiration of the period of exclusive marketing of a MUMS-designated 
drug, FDA will so notify the sponsor in writing.



Sec. 516.34  FDA recognition of exclusive marketing rights.

    (a) FDA will send the sponsor (or the permanent-resident U.S. agent, 
if applicable) timely written notice recognizing exclusive marketing 
rights when an application for a MUMS-designated drug has been 
conditionally approved or approved. The written notice will inform the 
sponsor of the requirements for maintaining MUMS-designated drug 
exclusive marketing rights for the full 7-year term. This notice will 
generally be contained in the letter conditionally approving or 
approving the application.
    (b) When an application is conditionally approved or approved for a 
MUMS-designated drug that qualifies for exclusive marketing rights, FDA 
will publish this information in the Federal Register at the time of the 
conditional approval or approval. This notice will generally be 
contained in the notice of conditional approval or approval of the 
application.



Sec. 516.36  Insufficient quantities of MUMS-designated drugs.

    (a) Under section 573 of the act, whenever FDA has reason to believe 
that sufficient quantities of a conditionally-approved or approved, 
MUMS-designated drug to meet the needs for which the drug was designated 
cannot be assured by the sponsor, FDA will so notify the sponsor of this 
possible insufficiency and will offer the sponsor the following options, 
one of which must be exercised by a time that FDA specifies:
    (1) Provide FDA information and data regarding how the sponsor can 
assure the availability of sufficient quantities of the MUMS-designated 
drug within a reasonable time to meet the needs for which the drug was 
designated; or
    (2) Provide FDA in writing the sponsor's consent for the conditional 
approval or approval of other applications for the same drug before the 
expiration of the 7-year period of exclusive marketing rights.
    (b) If, within the time that FDA specifies, the sponsor fails to 
consent to the conditional approval or approval of other applications 
and if FDA finds that the sponsor has not shown that it can assure the 
availability of sufficient quantities of the MUMS-designated drug to 
meet the needs for which the drug was designated, FDA will issue a 
written order terminating designation of the MUMS drug and the 
associated exclusive marketing rights. This order will state FDA's 
findings and conclusions and will constitute final agency

[[Page 137]]

action. An order terminating designation and associated exclusive 
marketing rights may issue whether or not there are other sponsors that 
can assure the availability of alternative sources of supply. Such an 
order will not withdraw the conditional approval or approval of an 
application. Once terminated under this section, neither designation, 
nor exclusive marketing rights may be reinstated.



Sec. 516.52  Availability for public disclosure of data and 
information in requests.

    (a) FDA will not publicly disclose the existence of a request for 
MUMS-drug designation under section 573 of the act prior to final FDA 
action on the request unless the existence of the request has been 
previously publicly disclosed or acknowledged.
    (b) Whether or not the existence of a pending request for 
designation has been publicly disclosed or acknowledged, no data or 
information in the request are available for public disclosure prior to 
final FDA action on the request.
    (c) Except as provided in paragraph (d) of this section, upon final 
FDA action on a request for designation, the public availability of data 
and information in the request will be determined in accordance with 
part 20 of this chapter and other applicable statutes and regulations.
    (d) In accordance with Sec. 516.28, FDA will make a cumulative list 
of all MUMS-drug designations available to the public and update such 
list periodically. In accordance with Sec. 516.29, FDA will give public 
notice of the termination of all MUMS-drug designations.



  Subpart C_Index of Legally Marketed Unapproved New Animal Drugs for 
                              Minor Species

    Source: 72 FR 69121, Dec. 6, 2007, unless otherwise noted.



Sec. 516.111  Scope of this subpart.

    This subpart implements section 572 of the act and provides 
standards and procedures to establish an index of legally marketed 
unapproved new animal drugs. This subpart applies only to minor species 
and not to minor use in major species. This index is only available for 
new animal drugs intended for use in a minor species for which there is 
a reasonable certainty that the animal or edible products from the 
animal will not be consumed by humans or food-producing animals and for 
new animal drugs intended for use only in a hatchery, tank, pond, or 
other similar contained man-made structure in an early, nonfood life 
stage of a food-producing minor species, where safety for humans is 
demonstrated in accordance with the standard of section 512(d) of the 
act (including, for an antimicrobial new animal drug, with respect to 
antimicrobial resistance). The index shall not include a new animal drug 
that is contained in, or a product of, a transgenic animal. Among its 
topics, this subpart sets forth the standards and procedures for:
    (a) Investigational exemptions for indexing purposes;
    (b) Submissions to FDA of requests for determination of eligibility 
of a new animal drug for indexing;
    (c) Establishment and operation of expert panels;
    (d) Submissions to FDA of requests for addition of a new animal drug 
to the index;
    (e) Modifications to index listings;
    (f) Publication of the index; and
    (g) Records and reports.



Sec. 516.115  Definitions.

    (a) The following definitions of terms apply only in the context of 
subpart C of this part:
    Director OMUMS means the Director of the Office of Minor Use and 
Minor Species Animal Drug Development of the FDA Center for Veterinary 
Medicine.
    Holder means the requestor of an index listing after the request is 
granted and the new animal drug is added to the index.
    Index means FDA's list of legally marketed unapproved new animal 
drugs for minor species.
    Intended use has the same meaning as that given in Sec. 516.13 of 
this chapter.
    Qualified expert panel means a panel that is composed of experts 
qualified by scientific training and experience to evaluate the target 
animal safety and

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effectiveness of a new animal drug under consideration for indexing.
    Requestor means the person making a request for determination of 
eligibility for indexing or a request for addition to the index.
    Transgenic animal means an animal whose genome contains a nucleotide 
sequence that has been intentionally modified in vitro, and the progeny 
of such an animal, provided that the term `transgenic animal' does not 
include an animal of which the nucleotide sequence of the genome has 
been modified solely by selective breeding.
    (b) The definitions of the following terms are given in Sec. 514.3 
of this chapter:
    Adverse drug experience.
    Product defect/manufacturing defect.
    Serious adverse drug experience.
    Unexpected adverse drug experience.
    (c) The definitions of the following terms are given in Sec. 516.3 
of this chapter:
    Same dosage form.
    Same drug.
    Same intended use.



Sec. 516.117  Submission of correspondence under this subpart.

    Unless directed otherwise by FDA, all correspondence relating to any 
aspect of the new animal drug indexing process described in this subpart 
must be addressed to the Director, OMUMS. The initial correspondence for 
a particular index listing should include the name and address of the 
authorized contact person. Notifications of changes in such person or 
changes of address of such person should be provided in a timely manner.



Sec. 516.119  Permanent-resident U.S. agent for foreign requestors
and holders.

    Every foreign requestor and holder shall name a permanent resident 
of the United States as their agent upon whom service of all processes, 
notices, orders, decisions, requirements, and other communications may 
be made on behalf of the requestor or holder. Notifications of changes 
in such agents or changes of address of agents should preferably be 
provided in advance, but not later than 60 days after the effective date 
of such changes. The permanent resident U.S. agent may be an individual, 
firm, or domestic corporation and may represent any number of requestors 
or holders. The name and address of the permanent-resident U.S. agent 
shall be submitted to the Director, OMUMS, and included in the index 
file.



Sec. 516.121  Meetings.

    (a) A requestor or potential requestor is entitled to one or more 
meetings to discuss the requirements for indexing a new animal drug.
    (b) Requests for such meetings should be in writing, be addressed to 
the Director, OMUMS, specify the participants attending on behalf of the 
requestor or potential requestor, and contain a proposed agenda for the 
meeting.
    (c) Within 30 days of receiving a request for a meeting, FDA will 
attempt to schedule the meeting at a time agreeable to both FDA and the 
person making the request.



Sec. 516.123  Informal conferences regarding agency administrative
actions.

    (a) Should FDA make an initial decision denying a request for 
determination of eligibility for indexing, terminating an 
investigational exemption, determining that a qualified expert panel 
does not meet the selection criteria, denying a request for addition to 
the index, or removing a new animal drug from the index, FDA will give 
written notice that specifies the grounds for the initial decision and 
provides an opportunity for an informal conference for review of the 
decision.
    (b) The written notice will include information for scheduling the 
informal conference and state that a written request for a conference 
must be made within 60 days of the date FDA sends its notice.
    (c) Within 45 days of receiving a request for an informal 
conference, FDA will schedule and hold the informal conference at a time 
agreeable to both FDA and the person making the request.
    (d) Such an informal conference will be conducted by a presiding 
officer who will be the Director of the Center for

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Veterinary Medicine or his or her designee, excluding the Director of 
the Office of Minor Use and Minor Species Animal Drug Development and 
other persons significantly involved in the initial decision.
    (e) The person requesting an informal conference must provide a 
written response to FDA's initial decision at least 2 weeks prior to the 
date of the scheduled meeting. Generally, this written response would be 
attached to the request for an informal conference. At the option of the 
person requesting an informal conference, such written response to FDA's 
initial decision may act in lieu of a face-to-face meeting. In this 
case, the informal conference will consist of a review by the presiding 
officer of the submitted written response.
    (f) The purpose of an informal conference is to discuss scientific 
and factual issues. It will involve a discussion of FDA's initial 
decision and any written response to that decision.
    (g) Internal agency review of a decision must be based on the 
information in the administrative file. If the person requesting an 
informal conference presents new information not in the file, the matter 
will be returned to the appropriate lower level in the agency for 
reevaluation based on the new information.
    (h) Informal conferences under this part are not subject to the 
separation of functions rules in Sec. 10.55 of this chapter.
    (i) The rules of evidence do not apply to informal conferences. No 
motions or objections relating to the admissibility of information and 
views will be made or considered, but any party to the conference may 
comment upon or rebut all such data, information and views.
    (j) [Reserved]
    (k) The presiding officer will prepare a written report regarding 
the subject of the informal conference that states and describes the 
basis for his or her findings. Whenever time permits, the parties to the 
informal conference will have 30 days to review and comment on the 
report.
    (l) The administrative record of the informal conference will 
consist of:
    (1) The notice providing an opportunity for an informal conference 
and the written response to the notice.
    (2) All written information and views submitted to the presiding 
officer at the conference or, at the discretion of the presiding 
officer, thereafter.
    (3) The presiding officer's written report.
    (4) All correspondence and memoranda of any and all meetings between 
the participants and the presiding officer.
    (m) The administrative record of the informal conference is closed 
to the submission of information at the close of the conference, unless 
the presiding officer specifically permits additional time for further 
submission.
    (n) The administrative record of the informal conference specified 
herein constitutes the exclusive record for decision.



Sec. 516.125  Investigational use of minor species new animal drugs
to support indexing.

    (a) The investigational use of a new animal drug or animal feed 
bearing or containing a new animal drug intended solely for 
investigational use in minor species shall meet the requirements of part 
511 of this chapter if the investigational use is for the purpose of:
    (1) Demonstrating human food safety under section 572(a)(1)(B) of 
the act;
    (2) Demonstrating safety with respect to individuals exposed to the 
new animal drug through its manufacture and use under section 
572(c)(1)(F) of the act;
    (3) Conducting an environmental assessment under section 
572(c)(1)(E) of the act; or
    (4) Obtaining approval of a new animal drug application or 
abbreviated new animal drug application under section 512(b) of the act.
    (b) Correspondence and information associated with investigations 
described in paragraph (a) of this section shall not be sent to the 
Director, OMUMS, but shall be submitted to FDA in accordance with the 
provisions of part 511 of this chapter.
    (c) The investigational use of a new animal drug or animal feed 
bearing or containing a new animal drug intended solely for 
investigational use in minor

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species, other than for an investigational use described in paragraph 
(a) of this section, shall meet the requirements of this section. For 
such investigations, all provisions of part 511 of this chapter apply 
with the following modifications:
    (1) Under Sec. 511.1(a)(1) of this chapter, the label statement is 
as follows:
    ``Caution. Contains a new animal drug for investigational use only 
in laboratory animals or for tests in vitro in support of index listing. 
Not for use in humans.''
    (2) Under Sec. 511.1(b)(1) of this chapter, the label statement is 
as follows:
    ``Caution. Contains a new animal drug for use only in 
investigational animals in clinical trials in support of index listing. 
Not for use in humans. Edible products of investigational animals are 
not to be used for food for humans or other animals unless authorization 
has been granted by the U.S. Food and Drug Administration or by the U.S. 
Department of Agriculture.''
    (3) Under Sec. 511.1(b)(4) of this chapter, the notice is titled 
``Notice of Claimed Investigational Exemption for a New Animal Drug for 
Index Listing'' and is submitted in duplicate to the Director, OMUMS.
    (4) Under Sec. 511.1(c)(3) of this chapter, if an investigator is 
determined to be ineligible to receive new animal drugs, each ``Notice 
of Claimed Investigational Exemption for a New Animal Drug for Index 
Listing'' and each request for indexing shall be examined with respect 
to the reliability of information submitted by the investigator.
    (5) Under Sec. 511.1(c)(4) and (d)(2) of this chapter, with respect 
to termination of exemptions, the sponsor of an investigation shall not 
be granted an opportunity for a regulatory hearing before FDA pursuant 
to part 16 of this chapter. Instead, the sponsor shall have an 
opportunity for an informal conference as described in Sec. 516.123.
    (6) Under Sec. 511.1(c)(5) of this chapter, if the Commissioner of 
Food and Drugs determines, after the unreliable data submitted by the 
investigator are eliminated from consideration, that the data remaining 
are such that a request for addition to the index would have been 
denied, FDA will remove the new animal drug from the index in accordance 
with Sec. 516.167.
    (d) The investigational use of a new animal drug or animal feed 
bearing or containing a new animal drug subject to paragraph (c) of this 
section shall not be subject to the good laboratory practice 
requirements in part 58 of this chapter.
    (e) Correspondence and information associated with investigations 
described in paragraph (c) of this section shall be sent to the 
Director, OMUMS, in accordance with the provisions of this section.



Sec. 516.129  Content and format of a request for determination
of eligibility for indexing.

    (a) Each request for determination of eligibility:
    (1) May involve only one drug (or one combination of drugs) in one 
dosage form;
    (2) May not involve a new animal drug that is contained in or a 
product of a transgenic animal;
    (3) May not involve the same drug in the same dosage form for the 
same intended use as a drug that is already approved or conditionally 
approved; and
    (4) Must be submitted separately.
    (b) A request for determination of eligibility for indexing may 
involve multiple intended uses and/or multiple minor species. However, 
if a request for determination of eligibility for indexing that contains 
multiple intended uses and/or multiple minor species cannot be granted 
in any part, the entire request will be denied.
    (c) A requestor must submit two copies of a dated request signed by 
the authorized contact person for determination of eligibility for 
indexing that contains the following:
    (1) Identification of the minor species or groups of minor species 
for which the new animal drug is intended;
    (2) Information regarding drug components and composition;
    (3) A statement of the intended use(s) of the new animal drug in the 
identified minor species or groups of minor species;
    (4) A statement of the proposed conditions of use associated with 
the stated intended use(s) of the new animal drug, including the 
proposed dosage,

[[Page 141]]

route of administration, contraindications, warnings, and any other 
significant limitations associated with the intended use(s) of the new 
animal drug;
    (5) A brief discussion of the need for the new animal drug for the 
intended use(s);
    (6) An estimate of the anticipated annual distribution of the new 
animal drug, in terms of the total quantity of active ingredient, after 
indexing;
    (7) Information to establish that the new animal drug is intended 
for use:
    (i) In a minor species for which there is a reasonable certainty 
that the animal or edible products from the animal will not be consumed 
by humans or food-producing animals; or
    (ii) In a hatchery, tank, pond, or other similar contained man-made 
structure in (which includes on) an early, non-food life stage of a 
food-producing minor species, and information to demonstrate food safety 
in accordance with the standards of section 512(d) of the act and Sec. 
514.111 of this chapter (including, for an antimicrobial new animal 
drug, with respect to antimicrobial resistance);
    (8) A description of the methods used in, and the facilities and 
controls used for, the manufacture, processing and packing of the new 
animal drug sufficient to demonstrate that the requestor has established 
appropriate specifications for the manufacture and control of the new 
animal drug and that the requestor has an understanding of current good 
manufacturing practices;
    (9) Either a claim for categorical exclusion under Sec. 25.30 or 
Sec. 25.33 of this chapter or an environmental assessment under Sec. 
25.40 of this chapter;
    (10) Information sufficient to support the conclusion that the new 
animal drug is safe under section 512(d) of the act with respect to 
individuals exposed to the new animal drug through its manufacture and 
use; and
    (11) The name and address of the contact person or permanent-
resident U.S. agent.



Sec. 516.131  Refuse to file a request for determination 
of eligibility for indexing.

    (a) If a request for determination of eligibility for indexing 
contains all of the information required by Sec. 516.129, FDA shall 
file it, and the filing date shall be the date FDA receives the request.
    (b) If a request for a determination of eligibility lacks any of the 
information required by Sec. 516.129, FDA will not file it, but will 
inform the requestor in writing within 30 days of receiving the request 
as to what information is lacking.



Sec. 516.133  Denying a request for determination of eligibility
for indexing.

    (a) FDA will deny a request for determination of eligibility for 
indexing if it determines upon the basis of the request evaluated 
together with any other information before it with respect to the new 
animal drug that:
    (1) The same drug in the same dosage form for the same intended use 
is already approved or conditionally approved;
    (2) There is insufficient information to demonstrate that the new 
animal drug is intended for use:
    (i) In a minor species for which there is a reasonable certainty 
that the animal or edible products from the animal will not be consumed 
by humans or food-producing animals, or
    (ii) In a hatchery, tank, pond, or other similar contained man-made 
structure in (which includes on) an early, non-food life stage of a 
food-producing minor species, and there is insufficient evidence to 
demonstrate safety for humans in accordance with the standard of section 
512(d) of the act and Sec. 514.111 of this chapter (including, for an 
antimicrobial new animal drug, with respect to antimicrobial 
resistance);
    (3) The new animal drug is contained in or is a product of a 
transgenic animal;
    (4) There is insufficient information to demonstrate that the 
requestor has established appropriate specifications for the manufacture 
and control of the new animal drug and that the requestor has an 
understanding of current good manufacturing practices;
    (5) The requester fails to submit an adequate environmental 
assessment under Sec. 25.40 of this chapter or fails to

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provide sufficient information to establish that the requested action is 
subject to categorical exclusion under Sec. 25.30 or Sec. 25.33 of 
this chapter;
    (6) There is insufficient information to determine that the new 
animal drug is safe with respect to individuals exposed to the new 
animal drug through its manufacture or use; or
    (7) The request for determination of eligibility for indexing fails 
to contain any other information required under the provisions of Sec. 
516.129.
    (b) FDA may deny a request for determination of eligibility for 
indexing if it contains any untrue statement of a material fact or omits 
material information.
    (c) When a request for determination of eligibility for indexing is 
denied, FDA will notify the requestor in accordance with Sec. 516.137.



Sec. 516.135  Granting a request for determination of eligibility
for indexing.

    (a) FDA will grant the request for determination of eligibility for 
indexing if none of the reasons described in Sec. 516.133 for denying 
such a request applies.
    (b) When a request for determination of eligibility for indexing is 
granted, FDA will notify the requestor in accordance with Sec. 516.137.



Sec. 516.137  Notification of decision regarding eligibility
for indexing.

    (a) Within 90 days after the filing of a request for a determination 
of eligibility for indexing based on Sec. 516.129(c)(7)(i), or 180 days 
for a request based on Sec. 516.129(c)(7)(ii), FDA shall grant or deny 
the request, and notify the requestor of FDA's decision in writing.
    (b) If FDA denies the request, FDA shall provide due notice and an 
opportunity for an informal conference as described in Sec. 516.123 
regarding its decision. A decision of FDA to deny a request for 
determination of eligibility for indexing following an informal 
conference shall constitute final agency action subject to judicial 
review.



Sec. 516.141  Qualified expert panels.

    (a) Establishment of a qualified expert panel. Establishing a 
qualified expert panel is the first step in the process of requesting 
the addition of a new animal drug to the index. A qualified expert panel 
may not be established until FDA has determined that the new animal drug 
is eligible for indexing. The requestor must choose members for the 
qualified expert panel in accordance with selection criteria listed in 
paragraph (b) of this section and submit information about these 
proposed members to FDA. FDA must determine whether the proposed 
qualified expert panel meets the selection criteria prior to the panel 
beginning its work. Qualified expert panels operate external to FDA and 
are not subject to the Federal Advisory Committee Act, as amended, 5 
U.S.C. App.
    (b) Criteria for the selection of a qualified expert panel. (1) A 
qualified expert panel member must be an expert qualified by training 
and experience to evaluate a significant aspect of target animal safety 
or effectiveness of the new animal drug under consideration.
    (2) A qualified expert panel member must certify that he or she has 
a working knowledge of section 572 of the act (the indexing provisions 
of the statute) and this subpart, and that he or she has also read and 
understood a clear written statement provided by the requestor stating 
his or her duties and responsibilities with respect to reviewing the new 
animal drug proposed for addition to the index.
    (3) A qualified expert panel member may not be an FDA employee.
    (4) A qualified expert panel must have at least three members.
    (5) A qualified expert panel must have members with a range of 
expertise such that the panel, as a whole, is qualified by training and 
experience to evaluate the target animal safety and effectiveness of the 
new animal drug under consideration.
    (6) Unless FDA makes a determination to allow participation 
notwithstanding an otherwise disqualifying financial interest, a 
qualified expert panel member must not have a conflict of interest or 
the appearance of a conflict of interest, as described in paragraph (g) 
of this section.
    (c) Requestor responsibilities. (1) The requestor must:

[[Page 143]]

    (i) Choose members for the qualified expert panel in accordance with 
selection criteria listed in paragraph (b) of this section.
    (ii) Provide each potential expert panel member a copy of section 
572 of the act (the indexing provisions of the statute) and this subpart 
and obtain certification that he or she has a working knowledge of the 
information.
    (iii) Provide each potential expert panel member a written statement 
describing the purpose and scope of his or her participation on the 
qualified expert panel and obtain certification that he or she has read 
and understood the information. The written statement should describe 
the duties and responsibilities of qualified expert panels and their 
members established by paragraphs (e) and (f) of this section, including 
the need to prepare a written report under Sec. 516.143.
    (iv) Obtain information from each potential expert panel member 
demonstrating that he or she is qualified by training and experience to 
evaluate the target animal safety and effectiveness of the new animal 
drug under consideration. This information can be obtained from a 
comprehensive curriculum vitae or similar document.
    (v) Notify each potential expert panel member that he or she must 
submit information relating to potential conflict of interest directly 
to FDA in a timely manner, as required in paragraph (e)(6) of this 
section.
    (2) The requestor must submit, in writing, the names and addresses 
of the proposed qualified expert panel members and sufficient 
information about each proposed member for FDA to determine whether the 
panel meets the selection criteria listed in paragraphs (b)(1) through 
(b)(5) of this section.
    (3) After FDA has determined that the qualified expert panel meets 
the selection criteria, the requestor must provide to the panel all 
information known by the requestor that is relevant to a determination 
of the target animal safety and the effectiveness of the new animal drug 
at issue. In addition, the requestor must notify FDA of the name of the 
qualified expert panel leader.
    (4) The requestor must immediately notify FDA if it believes a 
qualified expert panel member no longer meets the selection criteria 
listed in paragraph (b) of this section or is otherwise not in 
compliance with the requirements of this section.
    (5) If a qualified expert panel member cannot complete the review 
for which he or she was selected, the requestor must either choose a 
replacement or justify the continued work of the panel in the absence of 
the lost panelist. In either case, the requestor must submit sufficient 
information for FDA to determine whether the proposed revised qualified 
expert panel meets the selection criteria listed in paragraphs (b)(1) 
through (b)(5) of this section.
    (6) The requestor must keep copies of all information provided to, 
or received from, qualified expert panel members, including the written 
report, for 2 years after the completion of the report, or the product 
is added to the index, whichever occurs later, and make them available 
to a duly authorized employee of the agency at all reasonable times.
    (d) FDA responsibilities. (1) FDA will determine whether the 
requestor's proposed qualified expert panel meets the selection criteria 
listed in paragraph (b) of this section. FDA will expeditiously inform 
the requestor, in writing, of its determination. If FDA determines that 
the qualified expert panel does not meet the selection criteria, FDA 
will provide due notice and an opportunity for an informal conference as 
described in Sec. 516.123. A determination by FDA that a proposed 
qualified expert panel does not meet the selection criteria following an 
informal conference shall constitute final agency action subject to 
judicial review.
    (2) If FDA determines that a qualified expert panel no longer meets 
the selection criteria listed in paragraph (b) of this section or that 
the panel or its members are not in compliance with the requirements of 
this section, the agency will expeditiously inform the requestor, in 
writing, of this determination and provide due notice and an opportunity 
for an informal conference as described in Sec. 516.123. A 
determination by FDA, following an informal conference, that a qualified 
expert

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panel no longer meets the selection criteria listed in paragraph (b) of 
this section or that the panel or its members are not in compliance with 
the requirements of this section shall constitute final agency action 
subject to judicial review.
    (e) Responsibilities of a qualified expert panel member. A qualified 
expert panel member must do the following:
    (1) Continue to meet all selection criteria described in paragraph 
(b) of this section.
    (2) Act in accordance with generally accepted professional and 
ethical business practices.
    (3) Review all information relevant to a determination of the target 
animal safety and effectiveness of the new animal drug provided by the 
requestor. The panel should also consider all relevant information 
otherwise known by the panel members, including anecdotal information.
    (4) Participate in the preparation of the written report of the 
findings of the qualified expert panel, described in Sec. 516.143.
    (5) Sign, or otherwise approve in writing, the written report. Such 
signature or other written approval will serve as certification that the 
written report meets the requirements of the written report in Sec. 
516.143.
    (6) Provide the information relating to potential conflict of 
interest described in paragraph (g) of this section to FDA for its 
consideration. Such information should be submitted directly to the 
Director, OMUMS, when notified by the requestor.
    (7) Immediately notify the requestor and FDA of any change in 
conflict of interest status.
    (8) Certify at the time of submission of the written report that 
there has been no change in conflict of interest status, or identify and 
document to FDA any such change.
    (f) Additional responsibilities of a qualified expert panel leader. 
(1) The qualified expert panel leader must ensure that the activities of 
the panel are performed efficiently and in accordance with generally 
accepted professional and ethical business practices.
    (2) The qualified expert panel leader serves as the principal point 
of contact between representatives of the agency and the panel.
    (3) The qualified expert panel leader is responsible for submitting 
the written report and all notes or minutes relating to panel 
deliberations to the requestor.
    (4) The qualified expert panel leader must maintain a copy of the 
written report and all notes or minutes relating to panel deliberations 
that are submitted to the requestor for 2 years after the report is 
submitted. Such records must be made available to a duly authorized 
employee of the agency for inspection at all reasonable times.
    (g) Prevention of conflicts of interest. (1) For the purposes of 
this subpart, FDA will consider a conflict of interest to be any 
financial or other interest that could impair a person's objectivity in 
serving on the qualified expert panel or could create an unfair 
competitive advantage for a person or organization.
    (2) Factors relevant to whether there is a conflict of interest or 
the appearance of a conflict of interest include whether the qualified 
expert panel member, their spouse, their minor children, their general 
partners, or any organizations in which they serve as an officer, 
director, trustee, general partner or employee:
    (i) Is currently receiving or seeking funding from the requestor 
through a contract or research grant (either directly or indirectly 
through another entity, such as a university).
    (ii) Has any employment, contractual, or other financial arrangement 
with the requestor other than receiving a reasonable fee for serving as 
a member of the qualified expert panel.
    (iii) Has any ownership or financial interest in any drug, drug 
manufacturer, or drug distributor which will benefit from either a 
favorable or unfavorable evaluation or opinion.
    (iv) Has any ownership or financial interest in the new animal drug 
being reviewed by the qualified expert panel.
    (v) Has participated in the design, manufacture, or distribution of 
any drug that will benefit from either a favorable or unfavorable 
opinion of the qualified expert panel.

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    (vi) Has provided within 1 year any consultative services regarding 
the new animal drug being reviewed by the qualified expert panel.
    (vii) Has entered into an agreement in which fees charged or 
accepted are contingent upon the panel member making a favorable 
evaluation or opinion.
    (viii) Receives payment for services related to preparing 
information the requestor presents to the qualified expert panel, other 
than for services related to the written report described in Sec. 
516.143.
    (3) To permit FDA to make a decision regarding potential conflict of 
interest, a potential qualified expert panel member must submit to the 
Director, OMUMS, the following information relating to themselves, their 
spouse, their minor children, their general partners, or any 
organizations in which they serve as an officer, director, trustee, 
general partner or employee, regarding the following issues to the 
extent that they are, in any way, relevant to the subject of the review 
of the qualified expert panel:
    (i) Investments (for example, stocks, bonds, retirement plans, 
trusts, partnerships, sector funds, etc.), including for each the 
following: Name of the firm, type of investment, owner (self, spouse, 
etc.), number of shares / current value.
    (ii) Employment (full or part time, current or under negotiation), 
including for each the following: Name of the firm, relationship (self, 
spouse, etc.), position in firm, date employment or negotiation began.
    (iii) Consultant/advisor (current or under negotiation), including 
for each the following: Name of the firm, topic/issue, amount received, 
date initiated.
    (iv) Contracts, grants, Cooperation Research and Development 
Agreement (CRADAs) (current or under negotiation), including for each 
the following: Type of agreement, product under study and indications, 
amount of remuneration (institution/self), time period, sponsor 
(government, firm, institution, individual), role of the person (site 
investigator, principal investigator, co-investigator, partner, no 
involvement, other), awardee.
    (v) Patents/royalties/trademarks, including for each the following: 
Description, name of firm involved, income received.
    (vi) Expert witness (last 12 months or under negotiation), including 
for each the following: For or against, name of firm, issue, amount 
received.
    (vii) Speaking/writing (last 12 months or under negotiation), 
including for each the following: Firm, topic/issue, amount received 
(honorarium/travel), date.
    (viii) Whether the potential qualified expert panel member, their 
spouse, their minor children, their general partners or any 
organizations in which they serve as an officer, director, trustee, 
general partner or employee, have had, at any time in the past, 
involvement of the kind noted in paragraph (g)(3)(i) through (g)(3)(vii) 
of this section with respect to the animal drug that is the subject of 
the qualified expert panel review.
    (ix) Whether there are any other involvements (other kinds of 
relationships) that would give the appearance of a conflict of interest 
which have not been described in paragraph (g)(3)(i) through 
(g)(3)(viii) of this section.
    (x) In all cases, a response of ``no,'' ``none,'' or ``not 
applicable'' is satisfactory when there is no relevant information to 
submit.
    (xi) A certification statement signed by the potential qualified 
expert panel member to the effect that all information submitted is true 
and complete to the best of their knowledge, that they have read and 
understood their obligations as an expert panel member, and that they 
will notify FDA and the requestor of any change in their conflict of 
interest status.
    (4) The fact that a qualified expert panel member receives a 
reasonable fee for services as a member of the qualified expert panel, 
provided that the fee is no more than commensurate with the value of the 
time that the member devotes to the review process, does not constitute 
a conflict of interest or the appearance of a conflict of interest.



Sec. 516.143  Written report.

    The written report required in Sec. 516.145(b)(3) shall:

[[Page 146]]

    (a) Be written in English by a qualified expert panel meeting the 
requirements of Sec. 516.141;
    (b) Describe the panel's evaluation of all available target animal 
safety and effectiveness information relevant to the proposed use of the 
new animal drug, including anecdotal information;
    (c) For all information considered, including anecdotal information, 
include either a citation to published literature or a summary of the 
information;
    (d) State the panel's opinion regarding whether the benefits of 
using the new animal drug for the proposed use in a minor species 
outweigh its risks to the target animal, taking into account the harm 
being caused by the absence of an approved or conditionally-approved new 
animal drug for the minor species in question;
    (e) Be signed, or otherwise approved in writing, by all panel 
members, in accordance with Sec. 516.141; and
    (f) If the panel unanimously concludes that the benefits of using 
the new animal drug for the proposed use in a minor species outweigh its 
risks to the target animal, taking into account the harm being caused by 
the absence of an approved or conditionally-approved new animal drug for 
the minor species in question, the written report shall:
    (1) Provide draft labeling that includes all conditions of use and 
limitations of use of the new animal drug deemed necessary by the panel 
to assure that the benefits of use of the new animal drug outweigh the 
risks, or provide narrative information from which such labeling can be 
written by the requestor; and
    (2) Include a recommendation regarding whether the new animal drug 
should be limited to use under the professional supervision of a 
licensed veterinarian.



Sec. 516.145  Content and format of a request for addition to the 
index.

    (a) A requestor may request addition of a new animal drug to the 
index only after the new animal drug has been granted eligibility for 
indexing.
    (b) A requestor shall submit two copies of a dated request signed by 
the authorized contact for addition of a new animal drug to the index 
that contains the following:
    (1) A copy of FDA's determination of eligibility issued under Sec. 
516.137;
    (2) A copy of FDA's written determination that the proposed 
qualified expert panel meets the selection criteria provided for in 
Sec. 516.141(b);
    (3) A written report that meets the requirements of Sec. 516.143;
    (4) A proposed index entry that contains the information described 
in Sec. 516.157;
    (5) Proposed labeling, including representative labeling proposed to 
be used for Type B and Type C medicated feeds if the drug is intended 
for use in the manufacture of medicated feeds;
    (6) Anticipated annual distribution of the new animal drug, in terms 
of the total quantity of active ingredient, after indexing;
    (7) A written commitment to manufacture the new animal drug and 
animal feeds bearing or containing such new animal drug according to 
current good manufacturing practices;
    (8) A written commitment to label, distribute, and promote the new 
animal drug only in accordance with the index entry;
    (9) The name and address of the contact person or permanent-resident 
U.S. agent; and
    (10) A draft Freedom of Information summary which includes the 
following information:
    (i) A general information section that contains the name and address 
of the requestor and a description of the drug, route of administration, 
indications, and recommended dosage.
    (ii) A list of the names and affiliations of the members of the 
qualified expert panel, not including their addresses or other contact 
information.
    (iii) A summary of the findings of the qualified expert panel 
concerning the target animal safety and effectiveness of the drug.
    (iv) Citations of all publicly-available literature considered by 
the qualified expert panel.
    (v) For an early life stage of a food-producing minor species 
animal, a human food safety summary.
    (c) Upon specific request by FDA, the requestor shall submit the 
information described in Sec. 516.141 that it submitted

[[Page 147]]

to the qualified expert panel. Any such information not in English 
should be accompanied by an English translation.



Sec. 516.147  Refuse to file a request for addition to the index.

    (a) If a request for addition to the index contains all of the 
information required by Sec. 516.145(b), FDA shall file it, and the 
filing date shall be the date FDA receives the request.
    (b) If a request for addition to the index lacks any of the 
information required by Sec. 516.145, FDA will not file it, but will 
inform the requestor in writing within 30 days of receiving the request 
as to what information is lacking.



Sec. 516.149  Denying a request for addition to the index.

    (a) FDA will deny a request for addition to the index if it finds 
the following:
    (1) The same drug in the same dosage form for the same intended use 
is already approved or conditionally approved;
    (2) On the basis of new information, the new animal drug no longer 
meets the conditions for eligibility for indexing;
    (3) The request for indexing fails to contain information required 
under the provisions of Sec. 516.145;
    (4) The qualified expert panel fails to meet any of the selection 
criteria listed in Sec. 516.141(b);
    (5) The written report of the qualified expert panel and other 
information available to FDA is insufficient to permit FDA to determine 
that the benefits of using the new animal drug for the proposed use in a 
minor species outweigh its risks to the target animal, taking into 
account the harm caused by the absence of an approved or conditionally-
approved new animal drug for the minor species in question;
    (6) On the basis of the report of the qualified expert panel and 
other information available to FDA, the benefits of using the new animal 
drug for the proposed use in a minor species do not outweigh its risks 
to the target animal, taking into account the harm caused by the absence 
of an approved or conditionally-approved new animal drug for the minor 
species in question; or
    (7) The request contains any untrue statement of a material fact or 
omits material information.
    (b) When a request for addition to the index is denied, FDA will 
notify the requestor in accordance with Sec. 516.153.



Sec. 516.151  Granting a request for addition to the index.

    (a) FDA will grant the request for addition of a new animal drug to 
the index if none of the reasons described in Sec. 516.149 for denying 
such a request applies.
    (b) When a request for addition of a new animal drug to the index is 
granted, FDA will notify the requestor in accordance with Sec. 516.153.



Sec. 516.153  Notification of decision regarding index listing.

    (a) Within 180 days after the filing of a request for addition of a 
new animal drug to the index, FDA shall grant or deny the request and 
notify the requestor of FDA's decision in writing.
    (b) If FDA denies the request for addition of a new animal drug to 
the index, FDA shall provide due notice and an opportunity for an 
informal conference as described in Sec. 516.123. A decision of FDA to 
deny a request to index a new animal drug following an informal 
conference shall constitute final agency action subject to judicial 
review.



Sec. 516.155  Labeling of indexed drugs.

    (a) The labeling of an indexed drug that is found to be eligible for 
indexing under Sec. 516.129(c)(7)(i) shall state, prominently and 
conspicuously: ``NOT APPROVED BY FDA.--Legally marketed as an FDA 
indexed product. Extra-label use is prohibited.'' ``This product is not 
to be used in animals intended for use as food for humans or other 
animals.''
    (b) The labeling of an indexed drug that was found to be eligible 
for indexing for use in an early, non-food life stage of a food-
producing minor species animal, under Sec. 516.129(c)(7)(ii), shall 
state, prominently and conspicuously: ``NOT APPROVED BY FDA.--Legally 
marketed as an FDA indexed product. Extra-label use is prohibited.''

[[Page 148]]

    (c) The labeling of an indexed drug shall contain such other 
information as may be prescribed in the index listing.



Sec. 516.157  Publication of the index and content of an index listing.

    (a) FDA will make the list of indexed drugs available through the 
FDA Web site at http://www.fda.gov. A printed copy can be obtained by 
writing to the Freedom of Information Staff or by visiting FDA's Freedom 
of Information Staff's Public Reading Room at the address listed on the 
Agency's Web site at http://www.fda.gov.
    (b) The list will contain the following information for each indexed 
drug:
    (1) The name and address of the person who holds the index listing;
    (2) The name of the drug and the intended use and conditions of use 
for which it is indexed;
    (3) Product labeling; and
    (4) Conditions and any limitations that FDA deems necessary 
regarding use of the drug.

[72 FR 69121, Dec. 6, 2007; 76 FR 31470, June 1, 2011, as amended at 79 
FR 68115, Nov. 14, 2014]



Sec. 516.161  Modifications to indexed drugs.

    (a) After a drug is listed in the index, certain modifications to 
the index listing may be requested. Any modification of an index listing 
may not cause an indexed drug to be a different drug (or different 
combination of drugs) or a different dosage form. If such modification 
is requested, FDA will notify the holder that a new index listing is 
required for the new drug or dosage form.
    (b) Modifications to the indexed drug will fall under one of three 
categories and must be submitted as follows:
    (1) Urgent changes. (i) The following modifications to an indexed 
drug or its labeling should be made as soon as possible, and a request 
to modify the indexed drug should be concurrently submitted:
    (A) The addition to package labeling, promotional labeling, or 
prescription drug advertising of additional warning, contraindication, 
side effect, or cautionary information.
    (B) The deletion from package labeling, promotional labeling, and 
drug advertising of false, misleading, or unsupported indications for 
use or claims for effectiveness.
    (C) Changes in manufacturing methods or controls required to correct 
product or manufacturing defects that may result in serious adverse drug 
events.
    (ii) The modifications described in paragraph (b)(1)(i) of this 
section must be submitted to the Director, OMUMS, in the form of a 
request for modification of an indexed drug, and must contain sufficient 
information to permit FDA to determine the need for the modification and 
whether the modification appropriately addresses the need.
    (iii) FDA will take no action against an indexed drug or index 
holder solely because modifications of the kinds described in paragraph 
(b)(1)(i) of this section are placed into effect by the holder prior to 
receipt of a written notice granting the request if all the following 
conditions are met:
    (A) A request to modify the indexed drug providing a full 
explanation of the basis for the modifications has been submitted, 
plainly marked on the mailing cover and on the request as follows: 
``Special indexing request-- modifications being effected;''
    (B) The holder specifically informs FDA of the date on which such 
modifications are to be effected and submits two printed copies of any 
revised labeling to be placed in use, and
    (C) All promotional labeling and all drug advertising are promptly 
revised consistent with modifications made in the labeling on or within 
the indexed drug package.
    (2) Significant changes. (i) The following modifications to an 
indexed drug or its labeling may be made only after a request has been 
submitted to and subsequently granted by FDA:
    (A) Addition of an intended use.
    (B) Addition of a species.
    (C) Addition or alteration of an active ingredient.
    (D) Alteration of the concentration of an active ingredient.
    (E) Alteration of dose or dosage regimen.
    (F) Alteration of prescription or over-the-counter status.
    (ii) Each modification described in paragraph (b)(2)(i) of this 
section must

[[Page 149]]

go through the same review process as an original index listing and is 
subject to the same standards for review.
    (iii) Each submission of a request for a modification described in 
paragraph (b)(2)(i) of this section should contain only one type of 
modification unless one modification is actually necessitated by 
another, such as a modification of dose necessitated by a modification 
of the concentration of an active ingredient. Submissions relating to 
addition of an intended use for an existing species or addition of a 
species should be submitted separately, but each such submission may 
include multiple additional intended uses and/or multiple additional 
species.
    (3) Minor changes. All modifications other than those described in 
paragraphs (b)(1) and (b)(2) of this section including, but not limited 
to, formulation, labeling, and manufacturing methods and controls (at 
the same level of detail that these were described in the request for 
determination of eligibility for indexing) must be submitted as part of 
the annual indexed drug experience report or as otherwise required by 
Sec. 516.165.
    (c) When changes affect the index listing, it will be updated 
accordingly.



Sec. 516.163  Change in ownership of an index file.

    (a) A holder may transfer ownership of a drug's index file to 
another person.
    (1) The former owner shall submit in writing to FDA a statement that 
all rights in the index file have been transferred, giving the name and 
address of the new owner and the date of the transfer. The former owner 
shall also certify that a complete copy of the following, to the extent 
that they exist at the time of the transfer of ownership, has been 
provided to the new owner:
    (i) The request for determination of eligibility;
    (ii) The request for addition to the index;
    (iii) Any modifications to the index listing;
    (iv) Any records and reports under Sec. 516.165; and
    (v) All correspondence with FDA relevant to the indexed drug and its 
index listing.
    (2) The new owner shall submit the following information in writing 
to FDA:
    (i) The date that the change in ownership is effective;
    (ii) A statement that the new owner has a complete copy of all 
documents listed in paragraph (a)(1) of this section to the extent that 
they exist at the time of the transfer of ownership;
    (iii) A statement that the new owner understands and accepts the 
responsibilities of a holder of an indexed drug;
    (iv) The name and address of a new primary contact person or 
permanent-resident U.S. agent; and
    (v) A list of labeling changes associated with the change of 
ownership (e.g., a new trade name) as draft labeling, with complete 
final printed labeling to be submitted in the indexed drug annual report 
in accordance with Sec. Sec. 516.161 and 516.165.
    (b) Upon receiving the necessary information to support a change of 
ownership of a drug's index file, FDA will update its publicly-available 
listing in accordance with Sec. 516.157.



Sec. 516.165  Records and reports.

    (a) Scope and purpose. (1) The recordkeeping and reporting 
requirements of this section apply to all holders of indexed drugs, 
including indexed drugs intended for use in medicated feeds.
    (2) A holder is not required to report information under this 
section if the holder has reported the same information under Sec. 
514.80 of this chapter.
    (3) The records and reports referred to in this section are in 
addition to those required by the current good manufacturing practice 
regulations in parts 211, 225, and 226 of this chapter.
    (4) FDA will review the records and reports required in this section 
to determine, or facilitate a determination, whether there may be 
grounds for removing a drug from the index under section 572(f) of the 
act.
    (b) Recordkeeping requirements. (1) Each holder of an indexed drug 
must establish and maintain complete files containing full records of 
all information pertinent to the safety or effectiveness of the indexed 
drug. Such records must include information from foreign and domestic 
sources.

[[Page 150]]

    (2) The holder must, upon request from any authorized FDA officer or 
employee, at all reasonable times, permit such officer or employee to 
have access to copy and to verify all such records.
    (c) Reporting requirements--(1) Three-day indexed drug field alert 
report. The holder must inform the appropriate FDA District Office or 
local FDA resident post of any product or manufacturing defects that may 
result in serious adverse drug events within 3 working days of first 
becoming aware that such a defect may exist. The holder may initially 
provide this information by telephone or other electronic communication 
means, with prompt written followup. The mailing cover must be plainly 
marked ``3-Day Indexed Drug Field Alert Report.''
    (2) Fifteen-day indexed drug alert report. The holder must submit a 
report on each serious, unexpected adverse drug event, regardless of the 
source of the information. The holder must submit the report within 15 
working days of first receiving the information. The mailing cover must 
be plainly marked ``15-Day Indexed Drug Alert Report.''
    (3) Annual indexed drug experience report. The holder must submit 
this report every year on the anniversary date of the letter granting 
the request for addition of the new animal drug to the index, or within 
60 days thereafter. The report must contain data and information for the 
full reporting period. Any previously submitted information contained in 
the report must be identified as such. The holder may ask FDA to change 
the date of submission and, after approval of such request, file such 
reports by the new filing date. The report must contain the following:
    (i) The number of distributed units of each size, strength, or 
potency (e.g., 100,000 bottles of 100 5-milligram tablets; 50,000 10-
milliliter vials of 5- percent solution) distributed during the 
reporting period. This information must be presented in two categories: 
Quantities distributed domestically and quantities exported. This 
information must include any distributor-labeled product.
    (ii) If the labeling has changed since the last report, include a 
summary of those changes and the holder's and distributor's current 
package labeling, including any package inserts. For large-size package 
labeling or large shipping cartons, submit a representative copy (e.g., 
a photocopy of pertinent areas of large feed bags). If the labeling has 
not changed since the last report, include a statement of such fact.
    (iii) A summary of any changes made during the reporting period in 
the methods used in, and facilities and controls used for, manufacture, 
processing, and packing. This information must be presented in the same 
level of detail that it was presented in the request for determination 
of eligibility for indexing. Do not include changes that have already 
been submitted under Sec. 516.161.
    (iv) Nonclinical laboratory studies and clinical data not previously 
reported under this section.
    (v) Adverse drug experiences not previously reported under this 
section.
    (vi) Any other information pertinent to safety or effectiveness of 
the indexed drug not previously reported under this section.
    (4) Distributor's statement. At the time of initial distribution of 
an indexed drug by a distributor, the holder must submit a report 
containing the following:
    (i) The distributor's current product labeling. This must be 
identical to that in the index listing except for a different and 
suitable proprietary name (if used) and the name and address of the 
distributor. The name and address of the distributor must be preceded by 
an appropriate qualifying phrase such as ``manufactured for'' or 
``distributed by.''
    (ii) A signed statement by the distributor stating:
    (A) The category of the distributor's operations (e.g., wholesale or 
retail);
    (B) That the distributor will distribute the drug only under the 
indexed drug labeling;
    (C) That the distributor will promote the indexed drug only for use 
under the conditions stated in the index listing; and
    (D) If the indexed drug is a prescription new animal drug, that the 
distributor is regularly and lawfully engaged in the distribution or 
dispensing of prescription products.

[[Page 151]]

    (5) Other reporting. FDA may by order require that a holder submit 
information in addition to that required by this section or that the 
holder submit the same information but at different times or reporting 
periods.



Sec. 516.167  Removal from the index.

    (a) After due notice to the holder of the index listing and an 
opportunity for an informal conference as described in Sec. 516.123, 
FDA shall remove a new animal drug from the index if FDA finds that:
    (1) The same drug in the same dosage form for the same intended use 
has been approved or conditionally approved;
    (2) The expert panel failed to meet the requirements in Sec. 
516.141;
    (3) On the basis of new information before FDA, evaluated together 
with the evidence available to FDA when the new animal drug was listed 
in the index, the benefits of using the new animal drug for the indexed 
use do not outweigh its risks to the target animal, taking into account 
the harm caused by the absence of an approved or conditionally-approved 
new animal drug for the minor species in question;
    (4) Any of the conditions in Sec. 516.133(a)(2), (5), or (6) are 
present;
    (5) The manufacture of the new animal drug is not in accordance with 
current good manufacturing practices;
    (6) The labeling, distribution, or promotion of the new animal drug 
is not in accordance with the index listing;
    (7) The conditions and limitations of use associated with the index 
listing have not been followed; or
    (8) Any information used to support the request for addition to the 
index contains any untrue statement of material fact.
    (b) The agency may partially remove an indexing listing if, in the 
opinion of the agency, such partial removal would satisfactorily resolve 
a safety or effectiveness issue otherwise warranting removal of the 
listing under section 572(f)(1)(B) of the act.
    (c) FDA may immediately suspend a new animal drug from the index if 
FDA determines that there is a reasonable probability that the use of 
the drug would present a risk to the health of humans or other animals. 
The agency will subsequently provide due notice and an opportunity for 
an informal conference as described in Sec. 516.123.
    (d) A decision of FDA to remove a new animal drug from the index 
following an informal conference, if any, shall constitute final agency 
action subject to judicial review.



Sec. 516.171  Confidentiality of data and information in an index 
file.

    (a) For purposes of this section, the index file includes all data 
and information submitted to or incorporated by reference into the index 
file, such as data and information related to investigational use 
exemptions under Sec. 516.125, requests for determination of 
eligibility for indexing, requests for addition to the index, 
modifications to indexed drugs, changes in ownership, reports submitted 
under Sec. 516.165, and master files. The availability for public 
disclosure of any record in the index file shall be handled in 
accordance with the provisions of this section.
    (b) The existence of an index file will not be disclosed by FDA 
before an index listing has been made public by FDA, unless it has 
previously been publicly disclosed or acknowledged by the requestor.
    (c) If the existence of an index file has not been publicly 
disclosed or acknowledged, no data or information in the index file are 
available for public disclosure.
    (d) If the existence of an index file has been publicly disclosed or 
acknowledged before an index listing has been made public by FDA, no 
data or information contained in the file will be available for public 
disclosure before such index listing is made public, but the agency may, 
at its discretion, disclose a brief summary of such selected portions of 
the safety and effectiveness data as are appropriate for public 
consideration of a specific pending issue, e.g., at an open session of a 
Food and Drug Administration advisory committee or pursuant to an 
exchange of important regulatory information with a foreign government.
    (e) After FDA sends a written notice to the requestor granting a 
request for addition to the index, the following data and information in 
the index file

[[Page 152]]

are available for public disclosure unless extraordinary circumstances 
are shown:
    (1) All safety and effectiveness data and information previously 
disclosed to the public, as defined in Sec. 20.81 of this chapter.
    (2) A summary or summaries of the safety and effectiveness data and 
information submitted with or incorporated by reference in the index 
file. Such summaries do not constitute the full information described 
under section 572(c) and (d) of the act on which the safety or 
effectiveness of the drug may be determined. Such summaries will be 
based on the draft Freedom of Information summary submitted under Sec. 
516.145, which will be reviewed and, where appropriate, revised by FDA.
    (3) A protocol for a test or study, unless it is shown to fall 
within the exemption established for trade secrets and confidential 
commercial information in Sec. 20.61 of this chapter.
    (4) Adverse reaction reports, product experience reports, consumer 
complaints, and other similar data and information, after deletion of 
the following:
    (i) Names and any information that would identify the person using 
the product.
    (ii) Names and any information that would identify any third party 
involved with the report, such as a veterinarian.
    (5) A list of all active ingredients and any inactive ingredients 
previously disclosed to the public as defined in Sec. 20.81 of this 
chapter.
    (6) An assay method or other analytical method, unless it serves no 
regulatory or compliance purpose and is shown to fall within the 
exemption established in Sec. 20.61 of this chapter.
    (7) All correspondence and written summaries of oral discussions 
relating to the index file, in accordance with the provisions of part 20 
of this chapter.
    (f) The following data and information in an index file are not 
available for public disclosure unless they have been previously 
disclosed to the public as defined in Sec. 20.81 of this chapter, or 
they relate to a product or ingredient that has been abandoned and they 
no longer represent a trade secret or confidential commercial or 
financial information as defined in Sec. 20.61 of this chapter:
    (1) Manufacturing methods or processes, including quality control 
procedures.
    (2) Production, sales, distribution, and similar data and 
information, except that any compilation of such data and information 
aggregated and prepared in a way that does not reveal data or 
information which is not available for public disclosure under this 
provision is available for public disclosure.
    (3) Quantitative or semiquantitative formulas.
    (g) Subject to the disclosure provisions of this section, the agency 
shall regard the contents of an index file as confidential information 
unless specifically notified in writing by the holder of the right to 
disclose, to reference, or otherwise utilize such information on behalf 
of another named person.
    (h) For purposes of this regulation, safety and effectiveness data 
include all studies and tests of an animal drug on animals and all 
studies and tests on the animal drug for identity, stability, purity, 
potency, and bioavailability.
    (i) Safety and effectiveness data and information that have not been 
previously disclosed to the public are available for public disclosure 
at the time any of the following events occurs unless extraordinary 
circumstances are shown:
    (1) No work is being or will be undertaken to have the drug indexed 
in accordance with the request.
    (2) A final determination is made that the drug cannot be indexed 
and all legal appeals have been exhausted.
    (3) The drug has been removed from the index and all legal appeals 
have been exhausted.
    (4) A final determination has been made that the animal drug is not 
a new animal drug.

Subpart D [Reserved]



  Subpart E_Conditionally Approved New Animal Drugs For Minor Use and 
                              Minor Species

    Source: 72 FR 57200, Oct. 9, 2007, unless otherwise noted.

[[Page 153]]



Sec. 516.812  Enrofloxacin.

    (a) Specifications. Each milliliter (mL) of solution contains 100 
milligrams (mg) enrofloxacin.
    (b) Sponsor. See No. 000859 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in cattle--(1) Amount. Administer, by 
subcutaneous injection, a single dose of 12.5 mg/kilogram of body weight 
(5.7 mL/100 pounds of body weight). Administered dose volume should not 
exceed 20 mL per injection site.
    (2) Indications for use. For the treatment of clinical anaplasmosis 
associated with Anaplasma marginale in replacement dairy heifers under 
20 months of age and all classes of beef cattle except beef calves less 
than 2 months of age and beef bulls intended for breeding (any age). Not 
for use in any other class of dairy cattle or in veal calves.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian. Federal law prohibits the extra-label 
use of this drug in food-producing animals. Cattle intended for human 
consumption must not be slaughtered within 28 days from the last 
treatment. This product is not approved for use in female dairy cattle 
20 months of age or older including dry dairy cows. Use in these cattle 
may cause drug residues in milk and/or in calves born to these cows. A 
withdrawal period has not been established for this product in pre-
ruminating calves. Do not use in calves to be processed for veal.

[86 FR 13184, Mar. 8, 2021]



Sec. 516.1684  Paclitaxel.

    (a) Specifications. Each vial of powder contains 60 milligrams (mg) 
paclitaxel. Each milliliter of constituted solution contains 1 mg 
paclitaxel.
    (b) Sponsor. See No. 052818 in 510.600(c) of this chapter.
    (c) Conditions of use in dogs--(1) Amount. Administer 150 mg per 
square meter of body surface area intravenously over 15 to 30 minutes, 
once every 3 weeks, for up to 4 doses.
    (2) Indications for use. For the treatment of nonresectable stage 
III, IV, or V mammary carcinoma in dogs that have not received previous 
chemotherapy or radiotherapy. For the treatment of resectable and 
nonresectable squamous cell carcinoma in dogs that have not received 
previous chemotherapy or radiotherapy.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian. It is a violation of Federal law to 
use this product other than as directed in the labeling.

[79 FR 18158, Apr. 1, 2014]



Sec. 516.2065  Rabacfosadine.

    (a) Specifications. Each vial of powder contains 16.4 milligrams 
(mg) rabacfosadine. Each milliliter of constituted solution contains 8.2 
mg rabacfosadine.
    (b) Sponsor. See No. 086072 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in dogs--(1) Amount. Administer rabacfosadine 
at 1 mg/kilogram body weight as a 30-minute intravenous infusion, once 
every 3 weeks, for up to 5 doses.
    (2) Indications for use. For the treatment of lymphoma in dogs.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian. It is a violation of Federal law to 
use this product other than as directed in the labeling.

[82 FR 12169, Mar. 1, 2017]




PART 520_ORAL DOSAGE FORM NEW ANIMAL DRUGS--Table of Contents



Sec.
520.23 Acepromazine.
520.28 Acetazolamide.
520.38 Albendazole oral dosage forms.
520.38a Albendazole suspension.
520.38b Albendazole paste.
520.43 Afoxolaner.
520.48 Altrenogest.
520.62 Aminopentamide.
520.82 Aminopropazine oral dosage forms.
520.82a Aminopropazine.
520.82b Aminopropazine and neomycin.
520.88 Amoxicillin oral dosage forms.
520.88a Amoxicillin trihydrate film-coated tablets.
520.88b Amoxicillin trihydrate for oral suspension.
520.88c Amoxicillin trihydrate oral suspension.
520.88d Amoxicillin trihydrate soluble powder.
520.88e Amoxicillin trihydrate boluses.

[[Page 154]]

520.88f Amoxicillin trihydrate tablets.
520.88g Amoxicillin trihydrate and clavulanate potassium tablets.
520.88h Amoxicillin trihydrate and clavulanate potassium for oral 
          suspension.
520.90 Ampicillin oral dosage forms.
520.90a Ampicillin tablets.
520.90b Ampicillin capsules.
520.90c Ampicillin boluses.
520.100 Amprolium.
520.110 Apramycin sulfate soluble powder.
520.154 Bacitracin oral dosage forms.
520.154a Bacitracin methylenedisalicylate.
520.154b Bacitracin methylenedisalicylate and streptomycin sulfate 
          powder.
520.154c Bacitracin zinc soluble powder.
520.222 Bunamidine hydrochloride.
520.246 Butorphanol tablets.
520.260 n-Butyl chloride.
520.284 Cambendazole oral dosage forms.
520.284a Cambendazole suspension.
520.284b Cambendazole pellets.
520.284c Cambendazole paste.
520.292 Capromorelin.
520.301 Caramiphen ethanedisulfonate and ammonium chloride tablets.
520.302 Carnidazole tablets.
520.304 Carprofen.
520.314 Cefadroxil.
520.370 Cefpodoxime tablets.
520.376 Cephalexin.
520.390 Chloramphenicol oral dosage forms.
520.390a Chloramphenicol tablets.
520.390b Chloramphenicol capsules.
520.390c Chloramphenicol palmitate oral suspension.
520.420 Chlorothiazide.
520.434 Chlorphenesin carbamate tablets.
520.441 Chlortetracycline powder.
520.443 Chlortetracycline tablets and boluses.
520.445 Chlortetracycline and sulfamethazine powder.
520.446 Clindamycin capsules and tablets.
520.447 Clindamycin solution.
520.452 Clenbuterol syrup.
520.455 Clomipramine tablets.
520.462 Clorsulon drench.
520.522 Cyclosporine.
520.530 Cythioate oral liquid.
520.531 Cythioate tablets.
520.534 Decoquinate.
520.538 Deracoxib.
520.540 Dexamethasone oral dosage forms.
520.540a Dexamethasone powder.
520.540b Dexamethasone tablets and boluses.
520.540c Dexamethasone chewable tablets.
520.563 Dexamethasone chewable tablets.
520.580 Dichlorophene and toluene.
520.581 Dichlorophene tablets.
520.596 Dichlorvos powder.
520.598 Dichlorvos tablets.
520.600 Dichlorvos capsules and pellets.
520.602 Dichlorvos gel.
520.606 Diclazuril.
520.608 Dicloxacillin.
520.620 Diethylcarbamazine oral dosage forms.
520.622 Diethylcarbamazine citrate oral dosage forms.
520.622a Diethylcarbamazine citrate tablets.
520.622b Diethylcarbamazine citrate syrup.
520.622c Diethylcarbamazine citrate chew- able tablets.
520.623 Diethylcarbamazine and oxibendazole chewable tablets.
520.645 Difloxacin.
520.666 Dirlotapide.
520.763 Dithiazanine oral dosage forms.
520.763a Dithiazanine tablets.
520.763b Dithiazanine powder.
520.763c Dithiazanine iodide and piperazine citrate suspension.
520.766 Domperidone.
520.784 Doxylamine.
520.804 Enalapril.
520.812 Enrofloxacin.
520.816 Epsiprantel.
520.823 Erythromycin.
520.852 Estriol.
520.863 Ethylisobutrazine.
520.870 Etodolac.
520.903 Febantel oral dosage forms.
520.903a Febantel paste.
520.903b Febantel suspension.
520.903c Febantel and praziquantel paste.
520.903d Febantel tablets.
520.905 Fenbendazole oral dosage forms.
520.905a Fenbendazole suspension.
520.905b Fenbendazole granules.
520.905c Fenbendazole paste.
520.905d Fenbendazole powder.
520.905e Fenbendazole blocks.
520.928 Firocoxib tablets.
520.930 Firocoxib paste.
520.955 Florfenicol.
520.960 Flumethasone.
520.970 Flunixin.
520.980 Fluoxetine.
520.998 Fluralaner.
520.1010 Furosemide.
520.1044 Gentamicin sulfate oral dosage forms.
520.1044a Gentamicin sulfate oral solution.
520.1044b Gentamicin sulfate pig pump oral solution.
520.1044c Gentamicin sulfate powder.
520.1060 Glucose and glycine.
520.1084 Grapiprant.
520.1100 Griseofulvin.
520.1120 Haloxon oral dosage forms.
520.1120a Haloxon drench.
520.1120b Haloxon boluses.
520.1130 Hetacillin.
520.1150 Imepitoin.
520.1156 Imidacloprid.
520.1157 Iodinated casein.
520.1158 Iodochlorhydroxyquin.
520.1189 Itraconazole.
520.1192 Ivermectin paste.
520.1193 Ivermectin tablets and chewables.
520.1194 Ivermectin meal.

[[Page 155]]

520.1195 Ivermectin liquid.
520.1196 Ivermectin and pyrantel tablets.
520.1197 Ivermectin sustained-release bolus.
520.1198 Ivermectin and praziquantel paste.
520.1199 Ivermectin, pyrantel, and praziquantel tablets.
520.1200 Ivermectin, fenbendazole, and praziquantel tablets.
520.1204 Kanamycin, bismuth subcarbonate, activated attapulgite.
520.1242 Levamisole.
520.1242a Levamisole powder.
520.1242b Levamisole boluses or oblets.
520.1242c Levamisole and piperazine.
520.1242d Levamisole resinate.
520.1242e Levamisole hydrochloride effervescent tablets.
520.1242f Levamisole gel.
520.1242g Levamisole resinate and famphur paste.
520.1248 Levothyroxine.
520.1263 Lincomycin.
520.1263a Lincomycin tablets and syrup.
520.1263b Lincomycin powder.
520.1265 Lincomycin and spectinomycin powder.
520.1284 Liothyronine.
520.1286 Lotilaner.
520.1288 Lufenuron tablets.
520.1289 Lufenuron suspension.
520.1310 Marbofloxacin.
520.1315 Maropitant.
520.1320 Mebendazole.
520.1326 Mebendazole and trichlorfon oral dosage forms.
520.1326a Mebendazole and trichlorfon powder.
520.1326b Mebendazole and trichlorfon paste.
520.1330 Meclofenamic acid granules.
520.1331 Meclofenamic acid tablets.
520.1341 Megestrol.
520.1367 Meloxicam.
520.1372 Methimazole.
520.1380 Methocarbamol.
520.1408 Methylprednisolone.
520.1409 Methylprednisolone and aspirin.
520.1422 Metoserpate hydrochloride.
520.1430 Mibolerone.
520.1441 Milbemycin.
520.1443 Milbemycin oxime and lufenuron.
520.1445 Milbemycin oxime and praziquantel.
520.1447 Milbemycin oxime, lufenuron, and praziquantel tablets.
520.1450 Morantel tartrate oral dosage forms.
520.1450a Morantel tartrate bolus.
520.1450b Morantel tartrate cartridge.
520.1450c Morantel tartrate sustained-release trilaminate cylinder/
          sheet.
520.1451 Moxidectin tablets.
520.1452 Moxidectin gel.
520.1453 Moxidectin and praziquantel gel.
520.1454 Moxidectin solution.
520.1468 Naproxen.
520.1484 Neomycin.
520.1510 Nitenpyram.
520.1604 Oclacitinib.
520.1615 Omeprazole.
520.1616 Orbifloxacin tablets..
520.1618 Orbifloxacin suspension.
520.1628 Oxfendazole powder and pellets.
520.1629 Oxfendazole paste.
520.1630 Oxfendazole suspension.
520.1631 Oxfendazole and trichlorfon paste.
520.1638 Oxibendazole.
520.1660 Oxytetracycline.
520.1660a Oxytetracycline and carbomycin.
520.1660b Oxytetracycline hydrochloride capsules.
520.1660c Oxytetracycline hydrochloride tablets/boluses.
520.1660d Oxytetracycline powder.
520.1696 Penicillin.
520.1696a Penicillin G powder.
520.1696b Penicillin V powder.
520.1696c Penicillin V tablets.
520.1705 Pergolide.
520.1720 Phenylbutazone oral dosage forms.
520.1720a Phenylbutazone tablets and boluses.
520.1720b Phenylbutazone granules.
520.1720c Phenylbutazone paste.
520.1720d Phenylbutazone gel.
520.1720e Phenylbutazone powder.
520.1760 Phenylpropanolamine.
520.1780 Pimobendan.
520.1802 Piperazine-carbon disulfide complex oral dosage forms.
520.1802a Piperazine-carbon disulfide complex suspension.
520.1802b Piperazine-carbon disulfide complex boluses.
520.1802c Piperazine-carbon disulfide complex with phenothiazine 
          suspension.
520.1803 Piperazine citrate capsules.
520.1805 Piperazine phosphate with thenium closylate tablets.
520.1806 Piperazine suspension.
520.1840 Poloxalene.
520.1846 Polyoxyethylene (23) lauryl ether blocks.
520.1855 Ponazuril.
520.1860 Pradofloxacin.
520.1870 Praziquantel tablets.
520.1871 Praziquantel and pyrantel.
520.1872 Praziquantel, pyrantel pamoate, and febantel tablets.
520.1880 Prednisolone.
520.1900 Primidone.
520.1920 Prochlorperazine and isopropamide.
520.1921 Prochlorperazine, isopropamide, and neomycin.
520.1962 Promazine.
520.2002 Propiopromazine.
520.2041 Pyrantel pamoate chewable tablets.
520.2042 Pyrantel pamoate tablets.
520.2043 Pyrantel pamoate suspension.
520.2044 Pyrantel pamoate paste.
520.2045 Pyrantel tartrate powder.
520.2046 Pyrantel tartrate pellets.
520.2075 Robenacoxib.
520.2086 Sarolaner.

[[Page 156]]

520.2090 Sarolaner, moxidectin, and pyrantel.
520.2098 Selegiline.
520.2100 Selenium and vitamin E.
520.2123 Spectinomycin oral dosage forms.
520.2123a Spectinomycin tablets.
520.2123b Spectinomycin powder.
520.2123c Spectinomycin solution.
520.2130 Spinosad.
520.2134 Spinosad and milbemycin.
520.2138 Spironolactone and benazepril.
520.2150 Stanozolol.
520.2158 Streptomycin.
520.2170 Sulfabromomethazine.
520.2184 Sulfachloropyrazine.
520.2200 Sulfachlorpyridazine.
520.2215 Sulfadiazine/pyrimethamine suspension.
520.2218 Sulfamerazine, sulfamethazine, and sulfaquinoxaline powder.
520.2220 Sulfadimethoxine oral dosage forms.
520.2220a Sulfadimethoxine oral solution and soluble powder.
520.2220b Sulfadimethoxine suspension.
520.2220c Sulfadimethoxine tablet.
520.2220d Sulfadimethoxine bolus.
520.2220e Sulfadimethoxine extended-release bolus.
520.2220f Sulfadimethoxine and ormetoprim tablet.
520.2240 Sulfaethoxypyridazine.
520.2240a Sulfaethoxypyridazine solution.
520.2240b Sulfaethoxypyridazine tablets.
520.2260 Sulfamethazine oral dosage forms.
520.2260a Sulfamethazine oblet, tablet, and bolus.
520.2260b Sulfamethazine sustained-release boluses.
520.2260c Sulfamethazine sustained-release tablets.
520.2261 Sulfamethazine sodium oral dosage forms.
520.2261a Sulfamethazine solution.
520.2261b Sulfamethazine powder.
520.2280 Sulfamethizole and methenamine.
520.2325 Sulfaquinoxaline oral dosage forms.
520.2325a Sulfaquinoxaline powder and solution.
520.2325b Sulfaquinoxaline drench.
520.2330 Sulfisoxazole tablets.
520.2335 Telmisartan.
520.2340 Tepoxalin.
520.2345 Tetracycline.
520.2345a Tetracycline capsules.
520.2345b Tetracycline tablets.
520.2345c Tetracycline boluses.
520.2345d Tetracycline powder.
520.2345e Tetracycline solution.
520.2345f Tetracycline phosphate complex and sodium novobiocin capsules.
520.2345g Tetracycline hydrochloride and sodium novobiocin tablets.
520.2345h Tetracycline hydrochloride, sodium novobiocin, and 
          prednisolone tablets.
520.2362 Thenium closylate.
520.2380 Thiabendazole oral dosage forms.
520.2380a Thiabendazole top dressing and mineral protein block.
520.2380b Thiabendazole drench or paste.
520.2380c Thiabendazole bolus.
520.2380d Thiabendazole and piperazine citrate.
520.2380e Thiabendazole and piperazine phosphate.
520.2380f Thiabendazole and trichlorfon.
520.2455 Tiamulin.
520.2471 Tilmicosin.
520.2473 Tioxidazole oral dosage forms.
520.2473a Tioxidazole granules.
520.2473b Tioxidazole paste.
520.2475 Toceranib.
520.2481 Triamcinolone acetonide tablets.
520.2482 Triamcinolone acetonide oral powder.
520.2483 Triamcinolone.
520.2520 Trichlorfon oral dosage forms.
520.2520a Trichlorfon and atropine.
520.2520b Trichlorofon boluses.
520.2520c Trichlorofon granules.
520.2520d Trichlorfon, phenothiazine, and piperazine.
520.2582 Triflupromazine.
520.2598 Trilostane.
520.2604 Trimeprazine and prednisolone tablets.
520.2605 Trimeprazine and prednisolone capsules.
520.2610 Trimethoprim and sulfadiazine tablets.
520.2611 Trimethoprim and sulfadiazine paste.
520.2612 Trimethoprim and sulfadiazine suspension.
520.2613 Trimethoprim and sulfadiazine powder.
520.2640 Tylosin.
520.2645 Tylvalosin.

    Authority: 21 U.S.C. 360b.

    Source: 40 FR 13838, Mar. 27, 1975, unless otherwise noted.



Sec. 520.23  Acepromazine.

    (a) Specifications. Each tablet contains 5, 10, or 25 milligrams 
(mg) acepromazine maleate.
    (b) Sponsors. See No. 000010 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use--(1) Dogs--(i) Amount. 0.25 to 1.0 mg per 
pound (/lb) body weight orally.
    (ii) Indications for use. As an aid in tranquilization and as a 
preanesthetic agent.
    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.
    (2) Cats--(i) Amount. 0.5 to 1.0 mg/lb body weight orally.

[[Page 157]]

    (ii) Indications for use. As a tranquilizer.
    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

[75 FR 10165, Mar. 5, 2010]



Sec. 520.28  Acetazolamide.

    (a) Specifications. A powder containing acetazolamide sodium, USP 
equivalent to 25 percent acetazolamide activity.
    (b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in dogs--(1) Amount. Administer orally at a 
dosage of 5 to 15 milligrams per pound of body weight daily.
    (2) Indications for use. As an aid in the treatment of mild 
congestive heart failure and for rapid reduction of intraocular 
pressure.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[79 FR 28816, May 20, 2014]



Sec. 520.38  Albendazole oral dosage forms.



Sec. 520.38a  Albendazole suspension.

    (a) Specifications. Each milliliter of suspension contains 45.5 
milligrams (mg) (4.55 percent) or 113.6 mg (11.36 percent) albendazole.
    (b) Sponsor. See No. 054771 in Sec. 510.600 of this chapter.
    (c) Related tolerances. See Sec. 556.34 of this chapter.
    (d) Special considerations. See Sec. 500.25 of this chapter.
    (e) Conditions of use--(1) Cattle. Administer 11.36 percent 
suspension:
    (i) Amount. 4.54 mg/pound (lb) body weight (10 mg/kilogram (kg)) as 
a single oral dose using dosing gun or dosing syringe.
    (ii) Indications for use. For removal and control of adult liver 
flukes (Fasciola hepatica); heads and segments of tapeworms (Moniezia 
benedeni and M. expansa); adult and 4th stage larvae of stomach worms 
(brown stomach worms including 4th stage inhibited larvae (Ostertagia 
ostertagi), barberpole worm (Haemonchus contortus and H. placei), small 
stomach worm (Trichostrongylus axei)); adult and 4th stage larvae of 
intestinal worms (thread-necked intestinal worm (Nematodirus spathiger 
and N. helvetianus), small intestinal worm (Cooperia punctata and C. 
oncophora)); adult stages of intestinal worms (hookworm (Bunostomum 
phlebotomum), bankrupt worm (Trichostrongylus colubriformis), nodular 
worm (Oesophagostomum radiatum)); adult and 4th stage larvae of 
lungworms (Dictyocaulus viviparus).
    (iii) Limitations. Do not slaughter within 27 days of last 
treatment. Do not use in female dairy cattle of breeding age: Do not 
administer to female cattle during first 45 days of pregnancy or for 45 
days after removal of bulls.
    (2) Sheep. Administer 4.45 or 11.36 percent suspension:
    (i) Amount. 3.4 mg/lb body weight (7.5 mg/kg) as a single oral dose 
using dosing gun or dosing syringe.
    (ii) Indications for use. For removal and control of adult liver 
flukes (Fasciola hepatica and Fascioloides magna); heads and segments of 
common tapeworms (Moniezia expansa) and fringed tapeworm (Thysanosoma 
actinioides); adult and fourth stage larvae of stomach worms (brown 
stomach worm (Ostertagia circumcinta and Marshallagia marshalli), 
barberpole worm (Haemonchus contortus), small stomach worm 
(Trichostrongylus axei)); adult and fourth stage larvae of intestinal 
worms (thread-necked intestinal worm (Nematodirus spathiger and N. 
filicollis), Cooper's worm (Cooperia oncophora), bankrupt worm 
(Trichostrongylus colubriformis), nodular worm (Oesophagostomum 
columbianum), and large-mouth bowel worm (Chabertia ovina)); adult and 
larval stages of lungworms (Dictyocaulus filaria).
    (iii) Limitations. Do not slaughter within 7 days of last treatment. 
Do not administer to ewes during first 30 days of pregnancy or for 30 
days after removal of rams.
    (3) Goats. Administer 11.36 percent suspension:
    (i) Amount. 4.54 mg/lb body weight (10 mg/kg) as a single oral dose 
using dosing gun or dosing syringe.
    (ii) Indications for use. For the treatment of adult liver flukes 
(Fasciola hepatica) in nonlactating goats.
    (iii) Limitations. Do not slaughter within 7 days of last treatment. 
Do not administer to does during the first 30

[[Page 158]]

days of pregnancy or for 30 days after removal of bucks.

[73 FR 11027, Feb. 29, 2008. Redesignated at 78 FR 66264, Nov. 5, 2013, 
as amended at 79 FR 28816, May 20, 2014]



Sec. 520.38b  Albendazole paste.

    (a) Specifications. The product contains 30 percent albendazole.
    (b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
    (c) Related tolerances. See Sec. 556.34 of this chapter.
    (d) Conditions of use in cattle--(1) Amount. Equivalent to 4.54 
milligrams per 1 pound of body weight (10 milligrams per kilogram).
    (2) Indications for use. For removal and control of the following 
internal parasites of cattle: adult liver flukes (Fasciola hepatica); 
heads and segments of tapeworms (Moniezia benedeni, M. expansa); adult 
and 4th stage larvae of stomach worms (brown stomach worms including 4th 
stage inhibited larvae (Ostertagia ostertagi); barberpole worm 
(Haemonchus contortus, H. placei); small stomach worm (Trichostrongylus 
axei)); adult and 4th stages larvae of intestinal worms (thread-necked 
intestinal worm (Nematodirus spathiger, N. helvetianus); small 
intestinal worm (Cooperia punctata and C. oncophora)); adult stages of 
intestinal worms (hookworm (Bunostomum phlebotmum); bankrupt worm 
(Trichostrongylus colubriformis), nodular worm (Oesophagostomum 
radiatum)); adult and 4th stage larvae of lungworms (Dictyocaulus 
viviparus).
    (3) Limitations. Administer as a single oral dose. Do not slaughter 
within 27 days of last treatment. Do not use in female dairy cattle of 
breeding age. Do not administer to female cattle during first 45 days of 
pregnancy or for 45 days after removal of bulls. Consult your 
veterinarian for assistance in the diagnosis, treatment, and control of 
parasitism.

[54 FR 51385, Dec. 15, 1989, as amended at 56 FR 50653, Oct. 8, 1991; 60 
FR 55658, Nov. 2, 1995. Redesignated at 78 FR 66264, Nov. 5, 2013, as 
amended at 79 FR 28816, May 20, 2014]



Sec. 520.43  Afoxolaner.

    (a) Specifications. Each chewable tablet contains 11.3, 28.3, 68, or 
136 milligrams (mg) afoxolaner.
    (b) Sponsor. See No. 000010 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use--(1) Amount. Administer orally once a month at 
a minimum dosage of 1.14 mg/pound (lb) (2.5 mg/kilogram (kg)).
    (2) Indications for use. Kills adult fleas; for the treatment and 
prevention of flea infestations (Ctenocephalides felis); for the 
treatment and control of black-legged tick (Ixodes scapularis), American 
dog tick (Dermacentor variabilis), lone star tick (Amblyomma 
americanum), and brown dog tick (Rhipicephalus sanguineus) infestations 
in dogs and puppies 8 weeks of age and older, weighing 4 pounds of body 
weight or greater, for 1 month; and for the prevention of Borrelia 
burgdorferi infections as a direct result of killing Ixodes scapularis 
vector ticks.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[78 FR 66264, Nov. 5, 2013, as amended at 79 FR 37619, July 2, 2014; 84 
FR 8972, Mar. 13, 2019; 84 FR 39182, Aug. 9, 2019]



Sec. 520.48  Altrenogest.

    (a) Specifications. Each milliliter (mL) of solution contains 2.2 
milligrams (mg) altrenogest.
    (b) Sponsors. See Nos. 000061, 051072, and 061133 in Sec. 
510.600(c) of this chapter.
    (c) Tolerances. See Sec. 556.36 of this chapter.
    (d) Conditions of use--(1) Horses--(i) Amount. 1.0 mL per 110 pounds 
body weight (0.044 mg/kg) daily for 15 consecutive days.
    (ii) Indications for use. For suppression of estrus in mares.
    (iii) Limitations. Do not use in horses intended for human 
consumption. Federal law restricts this drug to use by or on the order 
of a licensed veterinarian.
    (2) Swine--(i) Amount. Administer 6.8 mL (15 mg altrenogest) per 
gilt once daily for 14 consecutive days by top-dressing on a portion of 
each gilt's daily feed.
    (ii) Indications for use. For synchronization of estrus in sexually 
mature gilts that have had at least one estrous cycle.
    (iii) Limitations. Do not use in gilts having a previous or current 
history of uterine inflammation (i.e., acute, subacute or chronic 
endometritis).

[[Page 159]]

Gilts must not be slaughtered for human consumption for 21 days after 
the last treatment.

[66 FR 47960, Sept. 17, 2001, as amended at 68 FR 62006, Oct. 31, 2003; 
72 FR 9455, Feb. 21, 2008; 74 FR 61516, Nov. 25, 2009; 77 FR 32012, May 
31, 2012; 80 FR 34278, June 16, 2015; 82 FR 21690, May 10, 2017; 83 FR 
13635, Mar. 30, 2018; 84 FR 8972, Mar. 13, 2019]



Sec. 520.62  Aminopentamide.

    (a) Specifications. Each tablet contains 0.2 milligram (mg) 
aminopentamide hydrogen sulphate.
    (b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in dogs and cats--(1) Amount. Administer 
orally every 8 to 12 hours as follows: For animals weighing up to 10 
pounds (lbs): 0.1 mg; for animals weighing 11 to 20 lbs: 0.2 mg; for 
animals weighing 21 to 50 lbs: 0.3 mg; for animals weighing 51 to 100 
lbs: 0.4 mg; for animal weighing over 100 lbs: 0.5 mg. Dosage may be 
gradually increased up to a maximum of five times the suggested dosage. 
Oral administration of tablets may be preceded by subcutaneous or 
intramuscular use of the injectable form of the drug.
    (2) Indications for use. For the treatment of vomiting and/or 
diarrhea, nausea, acute abdominal visceral spasm, pylorospasm, or 
hypertrophic gastritis.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[79 FR 28816, May 20, 2014]



Sec. 520.82  Aminopropazine oral dosage forms.



Sec. 520.82a  Aminopropazine.

    (a) Specifications. Each tablet contains aminopropazine fumarate 
equivalent to 25 percent aminopropazine base.
    (b) Sponsor. See No. 000061 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in dogs and cats--(1) Amount. Administer 
orally at a dosage of 1 to 2 milligrams per pound of body weight, 
repeated every 12 hours as indicated.
    (2) Indications for use. For reducing excessive smooth muscle 
contractions, such as occur in urethral spasms associated with 
urolithiasis.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[79 FR 28816, May 20, 2014]



Sec. 520.82b  Aminopropazine and neomycin.

    (a) Specifications. Each tablet contains aminopropazine fumarate 
equivalent to 25 percent aminopropazine base and neomycin sulfate 
equivalent to 50 milligrams (mg) of neomycin base.
    (b) Sponsor. See No. 000061 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in dogs--(1) Amount. Administer orally at a 
dosage of 1 to 2 mg per pound of body weight, repeated every 12 hours as 
indicated.
    (2) Indications for use. For control of bacterial diarrhea caused by 
organisms susceptible to neomycin and to reduce smooth muscle 
contractions.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[79 FR 28816, May 20, 2014]



Sec. 520.88  Amoxicillin oral dosage forms.



Sec. 520.88a  Amoxicillin trihydrate film-coated tablets.

    (a) Specifications. Each tablet contains amoxicillin trihydrate 
equivalent to 50, 100, 150, 200, or 400 milligrams (mg) amoxicillin.
    (b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use--(1) Dogs--(i) Amount. Administer orally 5 mg 
per pound (/lb) of body weight, twice a day for 5 to 7 days.
    (ii) Indications for use. Treatment of infections of the respiratory 
tract (tonsillitis, tracheobronchitis), genitourinary tract (cystitis), 
gastrointestinal tract (bacterial gastroenteritis), and soft tissues 
(abscesses, lacerations, wounds), caused by susceptible strains of 
Staphylococcus aureus, Streptococcus spp., Escherichia coli, Proteus 
mirabilis, and bacterial dermatitis caused by S. aureus, Streptococcus 
spp., and P. mirabilis.
    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.
    (2) Cats--(i) Amount. Administer orally 5 to 10 mg/lb of body 
weight, once daily for 5 to 7 days.

[[Page 160]]

    (ii) Indications for use. Treatment of infections caused by 
susceptible organisms as follows: upper respiratory tract due to S. 
aureus, Streptococcus spp., and E. coli; genitourinary tract (cystitis) 
due to S. aureus, Streptococcus spp., E. coli, and P. mirabilis; 
gastrointestinal tract due to E. coli; and skin and soft tissue 
(abscesses, lacerations, and wounds) due to S. aureus, Streptococcus 
spp., E. coli, and Pasteurella multocida.
    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

[57 FR 37319, Aug. 18, 1992, as amended at 60 FR 55658, Nov. 2, 1995; 79 
FR 28816, May 20, 2014]



Sec. 520.88b  Amoxicillin trihydrate for oral suspension.

    (a) Specifications. When reconstituted, each milliliter contains 
amoxicillin trihydrate equivalent to 50 milligrams (mg) amoxicillin.
    (b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
    (1) Conditions of use--(i) Dogs--(A) Amount. Administer orally 5 mg 
per pound (/lb) of body weight, twice a day for 5 to 7 days.
    (B) Indications for use. Treatment of infections caused by 
susceptible strains of organisms as follows: respiratory tract 
(tonsillitis, tracheobronchitis) caused by Staphylococcus aureus, 
Streptococcus spp., Escherichia coli, and Proteus mirabilis; 
genitourinary tract (cystitis) caused by S. aureus, Streptococcus spp., 
E. coli, and P. mirabilis; gastrointestinal tract (bacterial 
gastroenteritis) caused by S. aureus, Streptococcus spp., E. coli, and 
P. mirabilis; bacterial dermatitis caused by S. aureus, Streptococcus 
spp., and P. mirabilis; and soft tissues (abscesses, lacerations, and 
wounds) caused by S. aureus, Streptococcus spp., E. coli, and P. 
mirabilis.
    (C) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.
    (ii) Cats--(A) Amount. Administer orally 5 to 10 mg/lb of body 
weight, once daily for 5 to 7 days.
    (B) Indications for use. Treatment of infections caused by 
susceptible strains of organisms as follows: upper respiratory tract due 
to Staphylococcus spp., Streptococcus spp., Haemophilus spp., E. coli, 
Pasteurella spp., and P. mirabilis; genitourinary tract (cystitis) due 
to S. aureus, Streptococcus spp., E. coli, P. mirabilis, and 
Corynebacterium spp.; gastrointestinal tract due to E. coli, Proteus 
spp., Staphylococcus spp., and Streptococcus spp.; skin and soft tissue 
(abscesses, lacerations, and wounds) due to Staphylococcus spp., 
Streptococcus spp., E. coli, and Pasteurella multocida.
    (C) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.
    (2) [Reserved]
    (c) Sponsors. See Nos. 000856 and 051311 in Sec. 510.600(c) of this 
chapter.
    (1) Conditions of use. Dogs--(i) Amount. Administer orally 5 mg/lb 
of body weight, twice a day for 5 to 7 days.
    (ii) Indications for use. Treatment of bacterial dermatitis due to 
S. aureus, Streptococcus spp., Staphylococcus spp., and E. coli, and 
soft tissue infections (abscesses, wounds, lacerations) due to S. 
aureus, Streptococcus spp., E. coli, P. mirabilis and Staphylococcus 
spp.
    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.
    (2) [Reserved]

[57 FR 37319, Aug. 18, 1992; 57 FR 42623, Sept. 15, 1992, as amended at 
60 FR 55658, Nov. 2, 1995; 62 FR 13302, Mar. 20, 1997; 67 FR 67521, Nov. 
6, 2002; 68 FR 54658, Sept. 18, 2003; 68 FR 55824, Sept. 29, 2003; 79 FR 
28816, May 20, 2014; 81 FR 17607, Mar. 30, 2016]



Sec. 520.88c  Amoxicillin trihydrate oral suspension.

    (a) Specifications. Each 0.8-milliliter dose contains amoxicillin 
trihydrate equivalent to 40 milligrams (mg) amoxicillin.
    (b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
    (c) Related tolerances. See Sec. 556.38 of this chapter.
    (d) Conditions of use in swine--(1) Amount. Administer 40 mg orally 
twice a day using a dosing pump. Treat animals for 48 hours after all 
symptoms have subsided but not beyond 5 days.
    (2) Indications for use. Treatment of baby pigs under 10 pounds for 
porcine colibacillosis caused by Escherichia coli susceptible to 
amoxicillin.

[[Page 161]]

    (3) Limitations. Do not slaughter during treatment or for 15 days 
after latest treatment. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

[57 FR 37319, Aug. 18, 1992, as amended at 60 FR 55658, Nov. 2, 1995; 79 
FR 28817, May 20, 2014; 85 FR 18118, Apr. 1, 2020]



Sec. 520.88d  Amoxicillin trihydrate soluble powder.

    (a) Specifications. Each gram of powder contains amoxicillin 
trihydrate equivalent to 115.4 milligrams (mg) amoxicillin.
    (b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
    (c) Related tolerances. See Sec. 556.38 of this chapter.
    (d) Conditions of use in preruminating calves including veal 
calves--(1) Amount. Administer 400 mg per 100 pounds of body weight 
twice daily by drench or in milk. Treatment should be continued for 48 
hours after all symptoms have subsided but not to exceed 5 days.
    (2) Indications for use. Treatment of bacterial enteritis when due 
to susceptible Escherichia coli in preruminating calves including veal 
calves.
    (3) Limitations. Do not slaughter animals during treatment or for 20 
days after the latest treatment. Federal law restricts this drug to use 
by or on the order of a licensed veterinarian

[57 FR 37319, Aug. 18, 1992; 57 FR 42623, Sept. 15, 1992; 58 FR 18304, 
Apr. 8, 1993, as amended at 60 FR 55658, Nov. 2, 1995; 62 FR 5525, Feb. 
6, 1997; 79 FR 28817, May 20, 2014]



Sec. 520.88e  Amoxicillin trihydrate boluses.

    (a) Specifications. Each bolus contains amoxicillin trihydrate 
equivalent to 400 milligrams (mg) amoxicillin.
    (b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
    (c) Related tolerances. See Sec. 556.38 of this chapter.
    (d) Conditions of use in cattle--(1) Amount. Administer 400 mg per 
100 pounds of body weight twice daily. Treatment should be continued for 
48 hours after all symptoms have subsided but not to exceed 5 days.
    (2) Indications for use. Treatment of bacterial enteritis when due 
to susceptible Escherichia coli in preruminating calves including veal 
calves.
    (3) Limitations. Do not slaughter animals during treatment or for 20 
days after the latest treatment. Federal law restricts this drug to use 
by or on the order of a licensed veterinarian.

[57 FR 37320, Aug. 18, 1992, as amended at 60 FR 55659, Nov. 2, 1995; 62 
FR 5526, Feb. 6, 1997; 79 FR 28817, May 20, 2014]



Sec. 520.88f  Amoxicillin trihydrate tablets.

    (a) Specifications. Each tablet contains amoxicillin trihydrate 
equivalent to 50, 100, 200, or 400 milligrams (mg) amoxicillin.
    (b) Sponsors. See Nos. 051311 and 054771 in Sec. 510.600(c) of this 
chapter.
    (c) Conditions of use in dogs--(1) Amount. Administer 5 mg per pound 
of body weight twice daily for 5 to 7 days or 48 hours after all 
symptoms have subsided.
    (2) Indications for use. For treatment of bacterial dermatitis due 
to Staphylococcus aureus, Streptococcus spp., Staphylococcus spp., and 
Escherichia coli; and soft tissue infections (abscesses, wounds, 
lacerations) due to S. aureus, Enterococcus faecalis, E. coli, Proteus 
mirabilis, and Staphylococcus spp.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[79 FR 28817, May 20, 2014, as amended at 83 FR 64740, Dec. 18, 2018]



Sec. 520.88g  Amoxicillin trihydrate and clavulanate potassium 
tablets.

    (a) Specifications. Each tablet or chewable tablet contains 
amoxicillin trihydrate and clavulanate potassium equivalent to 50 
milligrams (mg) of amoxicillin and 12.5 mg clavulanic acid, 100 mg of 
amoxicillin and 25 mg clavulanic acid, 200 mg amoxicillin and 50 mg 
clavulanic acid, or 300 mg amoxicillin and 75 mg clavulanic acid.
    (b) Sponsors. See sponsors in Sec. 510.600(c) of this chapter:
    (1) No. 054771 for use of tablets and chewable tablets as in 
paragraph (c) of this section.
    (2) No. 026637 for use of tablets as in paragraph (c) of this 
section.
    (c) Conditions of use--(1) Dogs--(i) Amount. 6.25 milligrams 
(equivalent to 5 milligrams amoxicillin and 1.25 milligrams clavulanic 
acid) per pound of

[[Page 162]]

body weight twice daily for 5 to 7 days or for 48 hours after all signs 
have subsided. Deep pyoderma may require treatment for 21 days; do not 
treat for more than 30 days.
    (ii) Indications for use. Treatment of skin and soft tissue 
infections such as wounds, abscesses, cellulitis, superficial/juvenile 
and deep pyoderma due to susceptible strains of beta-lactamase 
(penicillinase) Staphylococcus aureus, non-beta-lactamase S. aureus, 
Staphylococcus spp., Streptococcus spp., and Escherichia coli. Treatment 
of periodontal infections due to susceptible strains of aerobic and 
anaerobic bacteria.
    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.
    (2) Cats--(i) Amount. 62.5 milligrams (50 milligrams amoxicillin and 
12.5 milligrams clavulanic acid) twice daily for 5 to 7 days or for 48 
hours after all signs have subsided. Urinary tract infections may 
require treatment for 10 to 14 days or longer. The maximum duration of 
treatment should not exceed 30 days.
    (ii) Indications for use. Treatment of skin and soft tissue 
infections, such as wounds, abscesses and cellulitis/dermatitis due to 
susceptible strains of beta-lactamase (penicillinase) producing S. 
aureus, non-beta-lactamase producing S. aureus, Staphylococcus spp., 
Streptococcus spp., E. coli, and Pasteurella spp. Also, treatment of 
urinary tract infections (cystitis) due to susceptible strains of E. 
coli.
    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

[57 FR 37320, Aug. 18, 1992, as amended at 60 FR 55659, Nov. 2, 1995; 63 
FR 13121, Mar. 18, 1998; 79 FR 28817, May 20, 2014; 80 FR 34278, June 
16, 2015; 82 FR 11508, Feb. 24, 2017; 82 FR 43484, Sept. 18, 2017; 82 FR 
58556, Dec. 13, 2017]



Sec. 520.88h  Amoxicillin trihydrate and clavulanate potassium
for oral suspension.

    (a) Specifications. When reconstituted, each milliliter contains 
amoxicillin trihydrate equivalent to 50 milligrams of amoxicillin with 
clavulanate potassium equivalent to 12.5 milligrams of clavulanic acid.
    (b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use--(1) Dogs--(i) Amount. 6.25 milligrams 
(equivalent to 5 milligrams amoxicillin and 1.25 milligrams clavulanic 
acid) per pound of body weight twice daily for 5 to 7 days or for 48 
hours after all signs have subsided. Deep pyoderma may require treatment 
for 21 days; do not treat for more than 30 days.
    (ii) Indications for use. Treatment of skin and soft tissue 
infections such as wounds, abscesses, cellulitis, superficial/juvenile 
and deep pyoderma due to susceptible strains of beta-lactamase 
(penicillinase) producing Staphylococcus aureus, nonbeta-lactamase 
Staphylococcus aureus, Staphylococcus spp., Streptococcus spp., and 
Escherichia coli. Treatment of periodontal infections due to susceptible 
strains of aerobic and anaerobic bacteria.
    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.
    (2) Cats--(i) Amount. 62.5 milligrams (1 milliliter) (50 milligrams 
amoxicillin and 12.5 milligrams clavulanic acid) twice daily. Administer 
48 hours after all signs have subsided. Maximum duration of treatment 
should not exceed 30 days.
    (ii) Indications for use. Treatment of feline skin and soft tissue 
infections, such as wounds, abscesses and cellulitis/dermatitis due to 
susceptible strains of beta-lactamase (penicillinase) producing S. 
aureus, nonbeta-lactamase S. aureus, Staphylococcus spp., Streptococcus 
spp., E. coli, Pasteurella multocida, and Pasteurella spp.
    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

[57 FR 37320, Aug. 18, 1992, as amended at 60 FR 55659, Nov. 2, 1995; 63 
FR 13121, Mar. 18, 1998; 79 FR 28817, May 20, 2014]



Sec. 520.90  Ampicillin oral dosage forms.



Sec. 520.90a  Ampicillin tablets.

    (a) Specifications. Each tablet contains ampicillin trihydrate 
equivalent to 50 or 100 milligrams of ampicillin.
    (b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.

[[Page 163]]

    (c) Conditions of use in dogs--(1) Amount. 5 milligrams per pound of 
body weight, at 8-hour intervals, 1 to 2 hours prior to feeding, to be 
continued 36 to 48 hours after all symptoms have subsided. If no 
improvement is seen within 5 days, stop treatment, reevaluate diagnosis, 
and change therapy.
    (2) Indications for use. Oral treatment of infections caused by 
susceptible organisms as follows: Upper respiratory infections, 
tonsillitis, and bronchitis due to Streptococcus spp., Staphylococcus 
spp., Escherichia coli, Proteus mirabilis, and Pasteurella spp., urinary 
tract infections (cystitis) due to Streptococcus spp., Staphylococcus 
spp., E., coli, P. mirabilis, and Enterococcus spp.; gastrointestinal 
infections due to Staphylococcus spp., Streptococcus spp., Enterococcus 
spp., and E. coli. ; infections associated with abscesses, lacerations, 
and wounds caused by Staphylococcus spp., and Streptococcus spp.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[57 FR 37321, Aug. 18, 1992, as amended at 60 FR 55659, Nov. 2, 1995; 79 
FR 28818, May 20, 2014. Redesignated at 85 FR 18118, Apr. 1, 2020]



Sec. 520.90b  Ampicillin capsules.

    (a) Specifications. Each capsule contains ampicillin trihydrate 
equivalent to 125, 250, or 500 milligrams of ampicillin.
    (b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use--(1) Dogs--(i) Amount. 5 to 10 milligrams per 
pound of body weight two or three times daily. In severe or acute 
conditions, 10 milligrams per pound of body weight, three times daily. 
Administer 1 to 2 hours prior to feeding.
    (ii) Indications for use. Treatment against strains of gram-negative 
and gram-positive organisms sensitive to ampicillin and associated with 
respiratory tract infections (tracheobronchitis and tonsillitis); 
urinary tract infections (cystitis); bacterial gastroenteritis; 
generalized infections (septicemia) associated with abscesses, 
lacerations, and wounds; and bacterial dermatitis.
    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.
    (2) Cats--(i) Amount. 10 to 30 milligrams per pound of body weight 
or three times daily. Administer 1 to 2 hours prior to feeding.
    (ii) Indications for use. Treatment against strains of gram-negative 
and gram-positive organisms sensitive to ampicillin and associated with 
respiratory tract infections (bacterial pneumonia); urinary tract 
infections (cystitis); and generalized infections (septicemia) 
associated with abscesses, lacerations, and wounds.
    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

[57 FR 37321, Aug. 18, 1992, as amended at 58 FR 61016, Nov. 19, 1993; 
79 FR 28818, May 20, 2014. Redesignated at 85 FR 18118, Apr. 1, 2020]



Sec. 520.90c  Ampicillin boluses.

    (a) Specifications. Each bolus contains ampicillin trihydrate 
equivalent to 400 milligrams of ampicillin.
    (b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
    (c) Related tolerances. See Sec. 556.40 of this chapter.
    (d) Conditions of use in nonruminating calves--(1) Amount. 5 
milligrams per pound of body weight twice daily not to exceed 4 days.
    (2) Indications for use. Oral treatment of bacterial enteritis 
(colibacillosis) caused by E. coli.
    (3) Limitations. Treated calves must not be slaughtered for food 
during treatment and for 7 days after the last treatment. Federal law 
restricts this drug to use by or on the order of a licensed 
veterinarian.

[57 FR 37322, Aug. 18, 1992, as amended at 58 FR 61016, Nov. 19, 1993; 
60 FR 55659, Nov. 2, 1995; 79 FR 28818, May 20, 2014. Redesignated and 
amended at 85 FR 18118, Apr. 1, 2020]



Sec. 520.100  Amprolium.

    (a) Specifications. (1) Each milliliter of solution contains 96 
milligrams (mg) amprolium (9.6 percent solution).
    (2) Each gram of powder contains 200 mg amprolium (20 percent).
    (b) Sponsors. See sponsors in 510.600(c) of this chapter.

[[Page 164]]

    (1) Nos. 016592 and 061133 for use of products described in 
paragraph (a) of this section as in paragraph (d) of this section.
    (2) No. 066104 for use of product described in paragraph (a)(1) of 
this section as in paragraph (d) of this section.
    (3) No. 051072 for use of product described in paragraph (a)(1) of 
this section as in paragraph (d)(1) of this section.
    (c) Related tolerances. See Sec. 556.50 of this chapter.
    (d) Conditions of use--(1) Growing chickens, turkeys, and laying 
hens. It is used in drinking water as follows:
    (i) Amount. Administer at the 0.012 percent level in drinking water 
as soon as coccidiosis is diagnosed and continue for 3 to 5 days (in 
severe outbreaks, give amprolium at the 0.024 percent level); continue 
with 0.006 percent amprolium-medicated water for an additional 1 to 2 
weeks.
    (ii) Indications for use. For the treatment of coccidiosis.
    (iii) Limitations. Use as the sole source of amprolium.
    (2) Calves. Administer concentrate solution or soluble powder as a 
drench or in drinking water as follows:
    (i) Indications for use and amounts--(A) As an aid in the prevention 
of coccidiosis caused by Eimeria bovis and E. zurnii, administer 5 mg 
per kilogram (mg/kg) body weight for 21 days during periods of exposure 
or when experience indicates that coccidiosis is likely to be a hazard.
    (B) As an aid in the treatment of coccidiosis caused by E. bovis and 
E. zurnii, administer 10 mg/kg body weight for 5 days.
    (ii) Limitations. Withdraw 24 hours before slaughter. A withdrawal 
period has not been established for this product in preruminating 
calves. Do not use in calves to be processed for veal. Use as the sole 
source of amprolium.

[71 FR 56346, Sept. 27, 2006, as amended at 72 FR 60551, Oct. 25, 2007; 
73 FR 45611, Aug. 6, 2008; 73 FR 70276, Nov. 20, 2008; 74 FR 10484, Mar. 
11, 2009; 76 FR 38554, July 1, 2011; 76 FR 40808, July 12, 2011; 78 FR 
23, Jan. 2, 2013; 78 FR 17596, Mar. 22, 2013; 78 FR 57058, Sept. 17, 
2013; 81 FR 22523, Apr. 18, 2016; 81 FR 59133, Aug. 29, 2016; 84 FR 
8972, Mar. 13, 2019; 86 FR 13184, Mar. 8, 2021]



Sec. 520.110  Apramycin sulfate soluble powder.

    (a) Specifications. A water soluble powder used to make a medicated 
drinking water containing apramycin sulfate equivalent to 0.375 gram of 
apramycin activity per gallon of drinking water.
    (b) Sponsor. See No. 058198 in Sec. 510.600(c) of this chapter.
    (c) Related tolerances. See Sec. 556.52 of this chapter.
    (d) Conditions of use in swine--(1) Amount. Administer in drinking 
water at the rate of 12.5 milligrams of apramycin per kilogram (5.7 
milligrams per pound) of body weight per day for 7 days.
    (2) Indications for use. For the control of porcine colibacillosis 
(weanling pig scours) caused by strains of Escherichia coli sensitive to 
apramycin.
    (3) Limitations. Do not slaughter treated swine for 28 days 
following treatment. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[47 FR 15771, Apr. 13, 1982, as amended at 49 FR 19642, May 9, 1984; 53 
FR 37753, Sept. 28, 1988; 79 FR 28818, May 20, 2014; 81 FR 48702, July 
26, 2016; 81 FR 94989, Dec. 27, 2016]



Sec. 520.154  Bacitracin oral dosage forms.



Sec. 520.154a  Bacitracin methylenedisalicylate.

    (a) Specifications. Each pound of soluble powder contains the 
equivalent of 50 grams of bacitracin activity for use as in paragraph 
(d)(1) or (d)(2) of this section, or the equivalent of 200 grams of 
bacitracin activity for use as in paragraph (d) of this section.
    (b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
    (c) Related tolerances. See Sec. 556.70 of this chapter.
    (d) Conditions of use--(1) Growing turkeys--(i) Amount. 400 
milligrams (mg) per gallon (gal) in drinking water.
    (ii) Indications for use. Aid in the control of transmissible 
enteritis complicated by organisms susceptible to bacitracin 
methylenedisalicylate.
    (iii) Limitations. Prepare a fresh solution daily.
    (2) Broiler and replacement chickens--(i) Amount. 100 mg per gal in 
drinking water.

[[Page 165]]

    (A) Indications for use. Aid in the prevention of necrotic enteritis 
caused by Clostridium perfringens susceptible to bacitracin 
methylenedisalicylate.
    (B) Limitations. Prepare a fresh solution daily.
    (ii) Amount. 200 to 400 mg per gal in drinking water. Administer 
continuously 5 to 7 days or as long as clinical signs persist, then 
reduce to prevention levels (100 mg/gal).
    (A) Indications for use. Treatment of necrotic enteritis caused by 
C. perfringens susceptible to bacitracin methylenedisalicylate.
    (B) Limitations. Prepare a fresh solution daily.
    (3) Swine--(i) Amount. 1 gram per gallon in drinking water.
    (ii) Indications for use. Treatment of swine dysentery associated 
with Brachyspira hyodysenteriae. Administer continuously for 7 days or 
until signs of dysentery disappear.
    (iii) Limitations. Prepare a fresh solution daily. Treatment not to 
exceed 14 days. If symptoms persist after 4 to 5 days consult a 
veterinarian. Not to be given to swine that weigh more than 250 pounds.
    (4) Growing quail--(i) Amount. 400 mg per gal in drinking water.
    (ii) Indications for use. For prevention of ulcerative enteritis due 
to Clostridium colinum susceptible to bacitracin methylenedisalicylate.
    (iii) Limitations. Prepare fresh solution daily. Use as sole source 
of drinking water.

[57 FR 37322, Aug. 18, 1992; 57 FR 42623, Sept. 15, 1992, as amended at 
63 FR 38474, July 17, 1998; 64 FR 13068, Mar. 17, 1999; 76 FR 53050, 
Aug. 25, 2011; 79 FR 28818, May 20, 2014; 80 FR 34278, June 16, 2015]



Sec. 520.154b  Bacitracin methylenedisalicylate and streptomycin
sulfate powder.

    (a) Specifications. Each gram of powder contains 200 units 
bacitracin methylenedisalicylate and streptomycin sulfate equivalent to 
20 milligrams of streptomycin.
    (b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in dogs--(1) Amount. Administer 1 level 
teaspoonful per 10 pounds of body weight three times daily, mixed in a 
small quantity of liquid or feed.
    (2) Indications for use. For the treatment of bacterial enteritis 
caused by pathogens susceptible to bacitracin and streptomycin such as 
Escherichia coli, Proteus spp., Staphylococcus spp., and Streptococcus 
spp., and for the symptomatic treatment of associated diarrhea.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[71 FR 17702, Apr. 7, 2006, as amended at 79 FR 28818, May 20, 2014; 81 
FR 17607, Mar. 30, 2016]



Sec. 520.154c  Bacitracin zinc soluble powder.

    (a) Specifications. Each pound contains the equivalent of not less 
than 5 grams of bacitracin.
    (b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
    (c) Related tolerances. See Sec. 556.70 of this chapter.
    (d) Conditions of use--(1) Broiler chickens--(i) Amount. 100 
milligrams per gallon in drinking water.
    (A) Indications for use. Prevention of necrotic enteritis caused by 
Clostridium perfringens susceptible to bacitracin zinc.
    (B) Limitations. Prepare a fresh solution daily.
    (ii) Amount. 200 to 400 milligrams per gallon in drinking water.
    (A) Indications for use. Control of necrotic enteritis caused by 
Clostridium perfringens susceptible to bacitracin zinc.
    (B) Limitations. Prepare a fresh solution daily.
    (2) Growing quail--(i) Amount. 500 milligrams per gallon in drinking 
water for 5 days followed by 165 milligrams per gallon in drinking water 
for 10 days.
    (ii) Indications for use. Control of ulcerative enteritis caused by 
Clostridium spp. susceptible to bacitracin zinc.
    (iii) Limitations. Prepare a fresh solution daily.

[57 FR 37322, Aug. 18, 1992, as amended at 67 FR 78355, Dec. 24, 2002; 
79 FR 28818, May 20, 2014]

[[Page 166]]



Sec. 520.222  Bunamidine hydrochloride.

    (a) Chemical name. N,N-Dibutyl-4-(hexyloxy)-1-naphthamidine 
hydrochloride.
    (b) Specifications. The drug is an oral tablet containing 100, 200, 
or 400 milligrams of bunamidine hydrochloride.
    (c) Sponsor. See No. 000061 in Sec. 510.600(c) of this chapter.
    (d) Conditions of use. (1) The drug is intended for oral 
administration to dogs for the treatment of the tapeworms Dipylidium 
caninum, Taenia pisiformis, and Echinococcus granulosus, and to cats for 
the treatment of the tapeworms Dipylidium caninum and Taenia 
taeniaeformis.
    (2) It is administered to cats and dogs at the rate of 25 to 50 
milligrams per kilogram of body weight. The drug should be given on an 
empty stomach and food should not be given for 3 hours following 
treatment.
    (3) Tablets should not be crushed, mixed with food, or dissolved in 
liquid. Repeat treatments should not be given within 14 days. The drug 
should not be given to male dogs within 28 days prior to their use for 
breeding. Do not administer to dogs or cats having known heart 
conditions.
    (4) For use only by or on the order of a licensed veterinarian.

[40 FR 13838, Mar. 27, 1975, as amended at 42 FR 13018, Mar. 8, 1977; 46 
FR 48642, Oct. 2, 1981; 61 FR 8873, Mar. 6, 1996; 62 FR 61624, Nov. 19, 
1997]



Sec. 520.246  Butorphanol tablets.

    (a) Specifications. Each tablet contains butorphanol tartrate 
equivalent to 1, 5, or 10 milligrams (mg) butorphanol base.
    (b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in dogs--(1) Amount. Administer 0.25 mg 
butorphanol base per pound of body weight. Repeat at intervals of 6 to 
12 hours as required. Treatment should not normally be required for 
longer than 7 days.
    (2) Indications for use. For the relief of chronic nonproductive 
cough associated with tracheobronchitis, tracheitis, tonsillitis, 
laryngitis, and pharyngitis associated with inflammatory conditions of 
the upper respiratory tract.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[79 FR 28818, May 20, 2014]



Sec. 520.260  n-Butyl chloride.

    (a) Specifications. Each capsule contains 221, 442, 884, or 1,768 
milligrams (mg); or 4.42 grams of n-butyl chloride.
    (b) Sponsors. See sponsors in Sec. 510.600(c) of this chapter:
    (1) No. 023851 for capsules containing 221, 442, 884, or 1,768 mg, 
or 4.42 grams (g); and
    (2) No. 054771 for capsules containing 221 mg.
    (c) Conditions of use in dogs--(1) Amount. Administer capsules 
orally based on body weight as follows:
    (i) Capsules containing 221 mg: Under 5 pounds, 1 capsule per 1\1/4\ 
pounds of body weight.
    (ii) Capsules containing 442 mg: Under 5 pounds, 1 capsule per 2\1/
2\ pounds of body weight.
    (iii) Capsules containing 884 mg:
    (A) Under 5 pounds, 1 capsule;
    (B) 5 to 10 pounds, 2 capsules;
    (C) 10 to 20 pounds, 3 capsules;
    (D) 20 to 40 pounds, 4 capsules;
    (E) Over 40 pounds, 5 capsules.
    (iv) Capsules containing 1,768 mg: Dogs weighing 5 to 10 pounds, 1 
capsule.
    (v) Capsules containing 4.42 g: Dogs weighing 40 pounds or over, 1 
capsule.
    (2) Indications for use. For the removal of ascarids (Toxocara canis 
and Toxascaris leonina) and hookworms (Ancylostoma caninum, Ancylostoma 
braziliense, and Uncinaria stenocephala) from dogs.
    (3) Limitations. Dogs should not be fed for 18 to 24 hours before 
being given the drug. Administration of the drug should be followed in 
\1/2\ to 1 hour with a mild cathartic. Normal feeding may be resumed 4 
to 8 hours after treatment. Animals subject to reinfection may be 
retreated in 2 weeks. A veterinarian should be consulted before using in 
severely debilitated dogs.

[86 FR 10819, Feb. 23, 2021]



Sec. 520.284  Cambendazole oral dosage forms.



Sec. 520.284a  Cambendazole suspension.

    (a) Specifications. Each fluid ounce contains 0.9 gram of 
cambendazole.

[[Page 167]]

    (b) Sponsor. No. 000010 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in horses--(1) Amount. Administer by stomach 
tube or as a drench at a dose of 0.9 gram of cambendazole per 100 pounds 
of body weight (20 milligrams per kilogram).
    (2) Indications for use. For the control of large strongyles 
(Strongylus vulgaris, S. edentatus, S. equinus); small strongyles 
(Trichonema, Poteriostomum, Cylicobrachytus, Craterostomum, 
Oesophagodontus); roundworms (Parascaris); pinworms (Oxyuris); and 
threadworms (Strongyloides).
    (3) Limitations. Do not use in horses intended for human 
consumption. Federal law restricts this drug to use by or on the order 
of a licensed veterinarian.

[40 FR 13838, Mar. 27, 1975. Redesignated at 41 FR 1276, Jan. 7, 1976, 
and amended at 42 FR 3838, Jan. 21, 1977; 62 FR 63270, Nov. 28, 1997; 79 
FR 28818, May 20, 2014. Redesignated at 81 FR 59133, Aug. 29, 2016; 84 
FR 39182, Aug. 9, 2019]



Sec. 520.284b  Cambendazole pellets.

    (a) Specifications. The drug is in feed pellets containing 5.3 
percent cambendazole.
    (b) Sponsor. No. 000010 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in horses--(1) Amount. Administer 20 
milligrams cambendazole per kilogram body weight (6 ounces per 1,000 
pounds) by mixing with normal grain ration given at one feeding. Doses 
for individual horses should be mixed and fed separately to assure that 
each horse will consume the correct amount. For animals maintained on 
premises where reinfection is likely to occur, re-treatments may be 
necessary. For most effective results, re-treat in 6 to 8 weeks.
    (2) Indications for use. For the control of large strongyles 
(Strongylus vulgaris, S. edentatus, S. equinus); small strongyles 
(Trichonema, Poteriostomum, Cylicobrachytus, Craterostomum, 
Oesophagodontus); roundworms (Parascaris); pinworms (Oxyuris); and 
threadworms (Strongyloides).
    (3) Limitations. Do not administer to pregnant mares during first 3 
months of pregnancy. Do not use in horses intended for human 
consumption. Consult your veterinarian for assistance in the diagnosis, 
treatment, and control of parasitism.

[41 FR 1276, Jan. 7, 1976, as amended at 42 FR 3838, Jan. 21, 1977; 62 
FR 63270, Nov. 28, 1997; 79 FR 28818, May 20, 2014. Redesignated at 81 
FR 59133, Aug. 29, 2016; 84 FR 39182, Aug. 9, 2019]



Sec. 520.284c  Cambendazole paste.

    (a) Specifications. The drug is a paste containing 45 percent 
cambendazole.
    (b) Sponsor. No. 000010 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in horses--(1) Amount. Administer 20 
milligrams cambendazole per kilogram body weight (5 grams per 550 pounds 
(250 kilograms)) by depositing the paste on the back of the tongue using 
a dosing gun. For animals maintained on premises where reinfection is 
likely to occur, re-treatments may be necessary. For most effective 
results, re-treat in 6 to 8 weeks.
    (2) Indications for use. For the control of large strongyles 
(Strongylus vulgaris, S. edentatus, S. equinus); small strongyles 
(Trichonema, Poteriostomum, Cylicobrachytus, Craterostomum, 
Oesophagodontus); roundworms (Parascaris); pinworms (Oxyuris); and 
threadworms (Strongyloides).
    (3) Limitations. Do not administer to pregnant mares during first 3 
months of pregnancy. Do not use in horses intended for human 
consumption. Consult your veterinarian for assistance in the diagnosis, 
treatment, and control of parasitism.

[41 FR 1276, Jan. 7, 1976, as amended at 42 FR 3838, Jan. 21, 1977; 62 
FR 63270, Nov. 28, 1997; 79 FR 28819, May 20, 2014. Redesignated at 81 
FR 59133, Aug. 29, 2016; 84 FR 39182, Aug. 9, 2019]



Sec. 520.292  Capromorelin.

    (a) Specifications. Each milliliter of solution contains:
    (1) 30 milligrams (mg) capromorelin; or
    (2) 20 mg capromorelin.
    (b) Sponsor. See No. 058198 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use--(1) Dogs. Use product described in paragraph 
(a)(1) of this section as follows:
    (i) Amount. Administer 3 mg/kg once daily by mouth.

[[Page 168]]

    (ii) Indications for use. For appetite stimulation in dogs.
    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.
    (2) Cats. Use product described in paragraph (a)(2) of this section 
as follows:
    (i) Amount. Administer 2 mg/kg once daily by mouth.
    (ii) Indications for use. For management of weight loss in cats with 
chronic kidney disease.
    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

[81 FR 59133, Aug. 29, 2016, as amended at 85 FR 4207, Jan. 24, 2020; 86 
FR 17063, Apr. 1, 2021]



Sec. 520.301  Caramiphen ethanedisulfonate and ammonium chloride 
tablets.

    (a) Specifications. Each tablet contains 10 milligrams of 5st 
caramiphen ethanedisulfonate and 80 milligrams of ammonium chloride.
    (b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in dogs--(1) Amount. One tablet per 15 to 30 
pounds of body weight every 4 to 6 hours.
    (2) Indications for use. For relief of cough.

[43 FR 55385, Nov. 28, 1978, as amended at 79 FR 28819, May 20, 2014. 
Redesignated at 80 FR 13229, Mar. 13, 2015]



Sec. 520.302  Carnidazole tablets.

    (a) Specifications. Each tablet contains 10 milligrams of 
carnidazole.
    (b) Sponsor. See 053923 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use--(1) Amount. Adult pigeons: 1 tablet (10 
milligrams); newly weaned pigeons: \1/2\ tablet (5 milligrams).
    (2) Indications for use. For treating trichomoniasis (canker) in 
ornamental and homing pigeons.
    (3) Limitations. Not for use in pigeons intended for human food. 
Consult your veterinarian for assistance in the diagnosis, treatment, 
and control of parasitism or when severely ill birds do not respond to 
treatment.

[54 FR 32336, Aug. 7, 1989. Redesignated at 80 FR 13229, Mar. 13, 2015]



Sec. 520.304  Carprofen.

    (a) Specifications. (1) Each caplet contains 25, 75, or 100 
milligrams (mg) carprofen.
    (2) Each chewable tablet contains 25, 75, or 100 mg carprofen.
    (3) Each chewable tablet contains 25, 37.5, 50, 75, or 100 mg 
carprofen.
    (b) Sponsors. See sponsors in Sec. 510.600(c) of this chapter for 
use as in paragraph (c) of this section.
    (1) Nos. 017033, 054771, 055529, and 062250 for use of product 
described in paragraphs (a)(1) and (2) of this section as in paragraph 
(c) of this section.
    (2) No. 058198 for use of product described in paragraph (a)(1) of 
this section as in paragraph (c) of this section.
    (3) No. 069043 for use of product described in paragraph (a)(3) of 
this section as in paragraph (c) of this section.
    (c) Conditions of use in dogs--(1) Amount. 2 mg per pound (/lb) of 
body weight once daily or 1 mg/lb twice daily. For the control of 
postoperative pain, administer approximately 2 hours before the 
procedure.
    (2) Indications for use. For the relief of pain and inflammation 
associated with osteoarthritis and for the control of postoperative pain 
associated with soft tissue and orthopedic surgeries.
    (3) Limitations. Federal Law restricts this drug to use by or on the 
order of a licensed veterinarian.

[61 FR 66581, Dec. 18, 1996, as amended at 64 FR 32181, June 16, 1999; 
66 FR 63165, Dec. 5, 2001; 67 FR 6866, Feb. 14, 2002; 67 FR 65038, Oct. 
23, 2002; 67 FR 65697, Oct. 28, 2002; 70 FR 30626, May 27, 2005; 71 FR 
51995, Sept. 1, 2006; 72 FR 68478, Dec. 5, 2007; 74 FR 21768, May 11, 
2009; 78 FR 52853, Aug. 27, 2013; 78 FR 66264, Nov. 5, 2013; 79 FR 
28819, May 20, 2014. Redesignated and amended at 80 FR 13229, Mar. 13, 
2015; 80 FR 34278, June 16, 2015; 80 FR 61296, Oct. 13, 2015; 82 FR 
43484, Sept. 18, 2017; 84 FR 12493, Apr. 2, 2019; 85 FR 4207, Jan. 24, 
2020; 86 FR 13184, Mar. 8, 2021; 86 FR 14817, Mar. 19, 2021]



Sec. 520.314  Cefadroxil.

    (a) Specifications. (1) Each tablet contains 50, 100, or 200 
milligrams (mg) or 1 gram of cefadroxil.
    (2) Each milliliter of suspension constituted from powder contains 
50 mg of cefadroxil.
    (b) Sponsor. See No. 000010 in Sec. 510.600(c) of this chapter.

[[Page 169]]

    (c) Conditions of use in dogs and cats--(1) Amount--(i) Dogs. 
Administer 10 mg per pound (/lb) body weight twice daily orally.
    (ii) Cats. Administer 10 mg/lb body weight once daily orally.
    (2) Indications for use--(i) Dogs. For the treatment of skin and 
soft tissue infections including cellulitis, pyoderma, dermatitis, wound 
infections, and abscesses due to susceptible strains of Staphylococcus 
aureus. For the treatment of genitourinary tract infections (cystitis) 
due to susceptible strains of Escherichia coli, Proteus mirabilis, and 
S. aureus.
    (ii) Cats. For the treatment of skin and soft tissue infections 
including abscesses, wound infections, cellulitis, and dermatitis caused 
by susceptible strains of Pasteurella multocida, S. aureus, 
Staphylococcus epidermidis, and Streptococcus spp.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[75 FR 10165, Mar. 5, 2010]



Sec. 520.370  Cefpodoxime tablets.

    (a) Specifications. (1) Each tablet contains cefpodoxime proxetil 
equivalent to 100 or 200 milligrams (mg) cefpodoxime.
    (2) Each chewable tablet contains cefpodoxime proxetil equivalent to 
100 or 200 mg cefpodoxime.
    (b) Sponsors. See sponsors in Sec. 510.600(c) of this chapter for 
uses as follows:
    (1) No. 026637 for use of product in paragraph (a)(1) of this 
section as in paragraph (c) of this section.
    (2) No. 054771 for use of products in paragraph (a) of this section 
as in paragraph (c) of this section.
    (c) Conditions of use in dogs--(1) Amount. 5 to 10 mg per kilogram 
(2.3 to 4.5 mg per pound) body weight daily for 5 to 7 days, or for 2 to 
3 days beyond the cessation of clinical signs, up to a maximum of 28 
days.
    (2) Indications for use. For the treatment of skin infections 
(wounds and abscesses) caused by susceptible strains of Staphylococcus 
pseudintermedius, S. aureus, Streptococcus canis (group G, beta-
hemolytic), Escherichia coli, Pasteurella multocida, and Proteus 
mirabilis.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[69 FR 52815, Aug. 30, 2004, as amended at 78 FR 5714, Jan. 28, 2013; 79 
FR 28819, May 20, 2014; 80 FR 13229, Mar. 13, 2015; 82 FR 12169, Mar. 1, 
2017]



Sec. 520.376  Cephalexin.

    (a) Specifications. Each chewable tablet contains 75, 150, 300, or 
600 milligrams (mg) cephalexin.
    (b) Sponsor. See No. 051311 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use--(1) Dogs--(i) Amount. Administer 22 mg per 
kilogram of body weight twice daily for 28 days.
    (ii) Indications for use. For the treatment of secondary superficial 
bacterial pyoderma in dogs caused by susceptible strains of 
Staphylococcus pseudintermedius.
    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.
    (2) [Reserved]

[77 FR 47512, Aug. 9, 2012]



Sec. 520.390  Chloramphenicol oral dosage forms.



Sec. 520.390a  Chloramphenicol tablets.

    (a) Specifications. Each tablet contains 50, 100, 250, or 500 
milligrams (mg); 1 or 2.5 grams (g) of chloramphenicol.
    (b) Sponsors. See Sec. 510.600(c) of this chapter:
    (1) For use as in paragraphs (c)(1), (c)(2)(i), and (c)(3) of this 
section:
    (i) No. 069043 for 100-, 250-, and 500-mg; and 1- and 2.5-g tablets;
    (ii) No. 054771 for 100-, 250-, and 500-mg tablets;
    (2) For use as in paragraphs (c)(1), (c)(2)(ii), and (c)(3) of this 
section:
    (i) No. 061133 for 50-, 100-, 250-, and 500-mg; and 1-g tablets;
    (ii) [Reserved]
    (c) Conditions of use in dogs--(1) Amount. Administer 25 mg per 
pound of body weight by mouth every 6 hours.
    (2) Indications for use--(i) For the treatment of bacterial 
pulmonary infections, bacterial infections of the urinary tract, 
bacterial enteritis, and bacterial infections associated with canine

[[Page 170]]

distemper caused by susceptible organisms.
    (ii) For the treatment of bacterial gastroenteritis associated with 
bacterial diarrhea, bacterial pulmonary infections, and bacterial 
infections of the urinary tract caused by susceptible organisms.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian. Federal law prohibits the extralabel 
use of this drug in food-producing animals.

[77 FR 4896, Feb. 1, 2012, as amended at 78 FR 21059, Apr. 9, 2013; 79 
FR 28819, May 20, 2014; 83 FR 48944, Sept. 28, 2018; 84 FR 8972, Mar. 
13, 2019]



Sec. 520.390b  Chloramphenicol capsules.

    (a) Specifications. Each capsule contains 50, 100, 250, or 500 
milligrams (mg) chloramphenicol.
    (b) Sponsors. See Nos. 050057 and 054771 in Sec. 510.600(c) of this 
chapter for use as in paragraph (d) of this section.
    (c) Special considerations. Federal law prohibits the extralabel use 
of this product in food-producing animals.
    (d) Conditions of use in dogs--(1) Amount. 25 mg per pound of body 
weight every 6 hours.
    (2) Indications for use. For treatment of bacterial pulmonary 
infections, bacterial infections of the urinary tract, bacterial 
enteritis, and bacterial infections associated with canine distemper 
caused by susceptible organisms.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[70 FR 75398, Dec. 20, 2005, as amended at 73 FR 18442, Apr. 4, 2008; 75 
FR 55676, Sept. 14, 2010; 79 FR 28819, May 20, 2014]



Sec. 520.390c  Chloramphenicol palmitate oral suspension.

    (a) Specifications. Each milliliter contains chloramphenicol 
palmitate equivalent to 30 milligrams of chloramphenicol.
    (b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use. Dogs--(1) Amount. 25 milligrams per pound of 
body weight every 6 hours. If no response is obtained in 3 to 5 days, 
discontinue use and reevaluate diagnosis.
    (2) Indications for use. Treatment of bacterial pulmonary 
infections, infections of the urinary tract, enteritis, and infections 
associated with canine distemper that are caused by organisms 
susceptible to chloramphenicol.
    (3) Limitations. Not for use in animals that are raised for food 
production. Must not be used in meat-, egg-, or milk-producing animals. 
The length of time that residues persist in milk or tissues has not been 
determined. Federal law restricts this drug to use by or on the order of 
a licensed veterinarian.

[57 FR 37323, Aug. 18, 1992; 57 FR 42623, Sept. 15, 1992, as amended at 
79 FR 28819, May 20, 2014]



Sec. 520.420  Chlorothiazide.

    (a) Specifications. (1) Each tablet contains 0.25 grams 
chlorothiazide.
    (2) Each bolus contains 2 grams chlorothiazide.
    (b) Sponsor. See No. 000010 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use--(1) Dogs--(i) Amount. Administer 5 to 10 
milligrams per pound of body weight two or three times daily.
    (ii) Indications for use. For treatment of congestive heart failure 
and renal edema.
    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.
    (2) Cows--(i)--Amount. Administer 2 grams once or twice daily for 3 
or 4 days.
    (ii) Indications for use. As an aid in reduction of postparturient 
udder edema.
    (iii) Limitations. Milk taken from dairy animals during treatment 
and for 72 hours (six milkings) after latest treatment must not be used 
for food. Federal law restricts this drug to use by or on the order of a 
licensed veterinarian.

[84 FR 39183, Aug. 9, 2019]



Sec. 520.434  Chlorphenesin carbamate tablets.

    (a) Specifications. Each tablet contains 400 milligrams of 
chlorphenesin carbamate.
    (b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in dogs--(1) Amount. 50 milligrams per pound 
of body weight on first day; 25 milligrams per pound of body weight each 
following day. Divide total daily dose into

[[Page 171]]

2 or 3 equal doses--administer at 12- or 8-hour intervals.
    (2) Indications for use. For use as an adjunct to therapy of acute 
inflammatory and traumatic conditions of skeletal muscles. The drug 
provides relief of the signs of discomfort associated with myositis, 
muscle sprains, traumatic injuries, stifle injuries--especially when 
administered before or after surgery--and invertebral disc syndrome (can 
be used concurrently with adrenal corticosteroids).
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[44 FR 16009, Mar. 16, 1979, as amended at 79 FR 28819, May 20, 2014]



Sec. 520.441  Chlortetracycline powder.

    (a) Specifications. Chlortetracycline powder contains not less than 
15 milligrams per gram chlortetracycline hydrochloride, or 
chlortetracycline bisulfate equivalent to 25.6, 64 or 102.4 grams per 
pound (56.4, 141 or 225.6 milligrams per gram) chlortetracycline 
hydrochloride.
    (b) Sponsors. See sponsors in Sec. 510.600(c) of this chapter for 
use as in paragraph (d) of this section.
    (1) Nos. 000010, 016592, 054771, and 069254 for use as in paragraph 
(d) of this section.
    (2) No. 066104 for use as in paragraphs (d)(4)(i)(A), (d)(4)(i)(B), 
and (d)(4)(ii) through (d)(4)(iv) of this section.
    (3) Nos. 069043, 069254, and 076475 for use as in paragraphs 
(d)(4)(i)(A), (d)(4)(i)(B), (d)(4)(ii), and (d)(4)(iii) of this section.
    (c) Related tolerances. See Sec. 556.150 of this chapter.
    (d) Conditions of use. (1) Use as chlortetracycline hydrochloride in 
drinking water as follows:
    (i) Swine--(A) Amount. Ten milligrams per pound of body weight daily 
in divided doses.
    (1) Indications for use. Control and treatment of bacterial 
enteritis (scours) caused by Escherichia coli and bacterial pneumonia 
associated with Pasteurella spp., Actinobacillus pleuropneumoniae 
(Haemophilus spp.), and Klebsiella spp.
    (2) Limitations. Prepare a fresh solution twice daily; as sole 
source of chlortetracycline; administer for not more than 5 days. 
Federal law restricts this drug to use by or on the order of a licensed 
veterinarian.
    (B) [Reserved]
    (ii) [Reserved]
    (2) Use as chlortetracycline hydrochloride in a drench or drinking 
water as follows:
    (i) Calves--(A) Amount. Ten milligrams per pound of body weight 
daily in divided doses.
    (1) Control and treatment of bacterial enteritis (scours) caused by 
E. coli and bacterial pneumonia (shipping fever) associated with 
Pasteurella spp., A. pleuropneumoniae (Haemophilus spp.), and Klebsiella 
spp.
    (2) Limitations. Prepare fresh solution daily; as sole source of 
chlortetracycline; administer for not more than 5 days; do not slaughter 
animals for food within 24 hours of treatment; do not administer this 
product with milk or milk replacers; administer 1 hour before or 2 hours 
after feeding milk or milk replacers; a withdrawal period has not been 
established in preruminating calves; do not use in calves to be 
processed for veal. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.
    (B) [Reserved]
    (ii) [Reserved]
    (3) [Reserved]
    (4) The following uses of chlortetracycline hydrochloride or 
chlortetracycline bisulfate in drinking water or drench were reviewed by 
the National Academy of Sciences/National Research Council (NAS/NRC) and 
found effective:
    (i) Chickens--(A) Amount. 200 to 400 milligrams per gallon.
    (1) Indications for use. Control of infectious synovitis caused by 
Mycoplasma synoviae.
    (2) Limitations. Prepare fresh solution daily; as sole source of 
chlortetracycline; do not use for more than 14 days; do not slaughter 
animals for food within 24 hours of treatment; do not use in laying 
chickens. Federal law restricts this drug to use by or on the order of a 
licensed veterinarian.
    (B) Amount. 400 to 800 milligrams per gallon.
    (1) Indications for use. Control of chronic respiratory disease and 
air-sac

[[Page 172]]

infections caused by M. gallisepticum and E. coli.
    (2) Limitations. Prepare fresh solution daily; as sole source of 
chlortetracycline; do not use for more than 14 days; do not slaughter 
animals for food within 24 hours of treatment; do not use in laying 
chickens. Federal law restricts this drug to use by or on the order of a 
licensed veterinarian.
    (C) Amount. One thousand milligrams per gallon.
    (1) Indications for use. Control of mortality due to fowl cholera 
caused by Pasteurella multocida susceptible to chlortetracycline.
    (2) Limitations. See paragraph (d)(4)(i)(A)(2) of this section.
    (ii) Growing turkeys--(A) Amount. 400 milligrams per gallon.
    (1) Indications for use. Control of infectious synovitis caused by 
M. synoviae.
    (2) Limitations. Prepare fresh solution daily; as sole source of 
chlortetracycline; do not use for more than 14 days; do not slaughter 
animals for food within 24 hours of treatment. Federal law restricts 
this drug to use by or on the order of a licensed veterinarian.
    (B) Amount. 25 milligrams per pound of body weight daily.
    (1) Indications for use. Control of complicating bacterial organisms 
associated with bluecomb (transmissible enteritis, coronaviral 
enteritis).
    (2) Limitations. Prepare fresh solution daily; as sole source of 
chlortetracycline; do not use for more than 14 days; do not slaughter 
animals for food within 24 hours of treatment. Federal law restricts 
this drug to use by or on the order of a licensed veterinarian.
    (iii) Swine--(A) Amount. 10 milligrams per pound body weight daily 
in divided doses.
    (B) Indications for use. Control and treatment of bacterial 
enteritis (scours) caused by E. coli and Salmonella spp. and bacterial 
pneumonia associated with Pasteurella spp., Actinobacillus 
pleuropneumoniae (Haemophilus spp.), and Klebsiella spp.
    (C) Limitations. Prepare fresh solution daily; as sole source of 
chlortetracycline; do not use for more than 5 days. For Nos. 016592 and 
021930, do not slaughter animals for food within 5 days of treatment. 
For No. 016592, do not slaughter animals for food within 24 hours of 
treatment. Federal law restricts this drug to use by or on the order of 
a licensed veterinarian.
    (iv) Calves, beef cattle, and nonlactating dairy cattle--(A) Amount. 
10 milligrams per pound daily in divided doses.
    (B) Indications for use. Control and treatment of bacterial 
enteritis (scours) caused by E. coli and Salmonella spp. and bacterial 
pneumonia (shipping fever complex) associated with Pasteurella spp., A. 
pleuropneumoniae (Haemophilus spp.), and Klebsiella spp.
    (C) Limitations. Prepare fresh solution daily; use as a drench; as 
sole source of chlortetracycline; do not use for more than 5 days; do 
not slaughter animals for food within 24 hours of treatment; do not use 
in lactating cattle; do not administer this product with milk or milk 
replacers; administer 1 hour before or 2 hours after feeding milk or 
milk replacers; a withdrawal period has not been established in 
preruminating calves; do not use in calves to be processed for veal. 
Federal law restricts this drug to use by or on the order of a licensed 
veterinarian.
    (5) Use in a drench or drinking water as follows:
    (i) Chickens--(A) Amount. 200 to 400 mg/gal, for 7 to 14 days.
    (1) Indications for use. Control of infectious synovitis caused by 
M. synoviae susceptible to chlortetracycline.
    (2) Limitations. Prepare fresh solution daily; use as the sole 
source of chlortetracycline; do not use for more than 14 consecutive 
days; do not use in laying chickens; do not administer to chickens 
within 24 hours of slaughter. Federal law restricts this drug to use by 
or on the order of a licensed veterinarian.
    (B) Amount. 400 to 800 mg/gal, for 7 to 14 days.
    (1) Indications for use. Control of chronic respiratory disease 
(CRD) and air-sac infections caused by M. gallisepticum and E. coli 
susceptible to chlortetracycline.
    (2) Limitations. As in paragraph (d)(5)(i)(A)(2) of this section.
    (C) Amount. One thousand mg/gal, for 7 to 14 days.

[[Page 173]]

    (1) Indications for use. Control of mortality due to fowl cholera 
caused by Pasteurella multocida susceptible to chlortetracycline.
    (2) Limitations. As in paragraph (d)(5)(i)(A)(2) of this section.
    (ii) Growing Turkeys--(A) Amount. 400 mg/gal, for 7 to 14 days.
    (1) Indications for use. Control of infectious synovitis caused by 
Mycoplasma synoviae susceptible to chlortetracycline.
    (2) Limitations. Prepare fresh solution daily; use as the sole 
source of chlortetracycline; do not use for more than 14 consecutive 
days; do not administer to growing turkeys within 24 hours of slaughter. 
Federal law restricts this drug to use by or on the order of a licensed 
veterinarian.
    (B) Amount. 25 mg/lb body weight daily, for 7 to 14 days.
    (1) Indications for use. Control of complicating bacterial organisms 
associated with bluecomb (transmissible enteritis, coronaviral 
enteritis) susceptible to chlortetracycline.
    (2) Limitations. As in paragraph (d)(5)(ii)(A)(2) of this section.
    (iii) Swine--(A) Amount. 10 mg/lb body weight daily, for 3 to 5 
days.
    (B) Indications for use. Control and treatment of bacterial 
enteritis (scours) caused by E. coli and Salmonella spp., and bacterial 
pneumonia associated with Pasteurella spp., A. pleuropneumoniae, and 
Klebsiella spp. susceptible to chlortetracycline.
    (C) Limitations. Prepare fresh solution daily; use as the sole 
source of chlortetracycline; do not use for more than 5 days; do not 
administer to swine within 24 hours of slaughter. Federal law restricts 
this drug to use by or on the order of a licensed veterinarian.
    (iv) Calves, beef cattle, and nonlactating dairy cattle--(A) Amount. 
10 mg/lb body weight daily in divided doses, for 3 to 5 days.
    (B) Indications for use. Control and treatment of bacterial 
enteritis (scours) caused by Escherichia coli and Salmonella spp., and 
bacterial pneumonia associated with Pasteurella spp., Histophilus spp., 
and Klebsiella spp. susceptible to chlortetracycline.
    (C) Limitations. Prepare fresh solution daily; use as a drench; use 
as the sole source of chlortetracycline; do not use for more than 5 
days; do not administer to cattle within 24 hours of slaughter; do not 
use in lactating dairy cattle; do not administer this product with milk 
or milk replacers; administer 1 hour before or 2 hours after feeding 
milk or milk replacers; a withdrawal period has not been established in 
preruminating calves; do not use in calves to be processed for veal. 
Federal law restricts this drug to use by or on the order of a licensed 
veterinarian.

[57 FR 37324, Aug. 18, 1992]

    Editorial Note: For Federal Register citations affecting Sec. 
520.441, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and at www.govinfo.gov.



Sec. 520.443  Chlortetracycline tablets and boluses.

    (a) Specifications. Each tablet/bolus contains 25, 250, or 500 
milligrams (mg) chlortetracycline hydrochloride.
    (b) Sponsor. See Nos. 016592 and 069043 in Sec. 510.600(c) of this 
chapter.
    (c) Related tolerances. See Sec. 556.150 of this chapter.
    (d) Conditions of use in calves--(1) Amount. One 250 milligram bolus 
per 50 pounds of body weight twice a day for 3 to 5 days.
    (i) Indications for use. Treatment of bacterial enteritis (scours) 
caused by Escherichia coli and bacterial pneumonia associated with 
Pasteurella spp., Klesbsiella spp., and Haemophilus spp.
    (ii) Limitations. Administer bolus directly by mouth or crush and 
dissolve in milk or water for drenching or bucket feeding; if no 
improvement is noted after 3 days of treatment, consult a veterinarian; 
do not use for more than 5 days; do not administer within 24 hours of 
slaughter.
    (2) Amount. One 25 milligram tablet for each 5 pounds of body weight 
every 12 hours daily for 3 to 5 days.
    (i) Indications for use. Control and treatment of bacterial 
enteritis (scours) caused by E. coli and Salmonella spp. and bacterial 
pneumonia associated with Pasteurella spp., Haemophilus spp., and 
Klebsiella spp., susceptible to chlortetracycline.
    (ii) Limitations. Administer tablet directly by mouth or crush and 
dissolve

[[Page 174]]

in water for drenching; if no improvement is noted after 3 days of 
treatment, consult a veterinarian; do not use for more than 5 days; when 
feeding milk or milk replacer, administration 1 hour before or 2 hours 
after feeding; do not administer within 24 hours of slaughter.
    (3) Amount. One 500 milligram bolus per 100 pounds of body weight 
twice a day for 3 to 5 days.
    (i) Indications for use. Treatment of bacterial enteritis (scours) 
caused by E. coli and Salmonella spp., and bacterial pneumonia 
associated with Pasteurella spp., Haemophilus spp., and Klebsiella spp., 
susceptible to chlortetracycline.
    (ii) Limitations. Administer directly by mouth or crush and dissolve 
in water for drenching; if no improvement is noted after 3 days of 
treatment, consult a veterinarian; do not use for more than 5 days; do 
not administer within 24 hours of slaughter.

[57 FR 37325, Aug. 18, 1992, as amended at 67 FR 78355, Dec. 24, 2002. 
Redesignated and amended at 76 FR 49649, Aug. 11, 2011; 78 FR 21059, 
Apr. 9, 2013; 81 FR 17607, Mar. 30, 2016; 83 FR 48944, Sept. 28, 2018]



Sec. 520.445  Chlortetracycline and sulfamethazine powder.

    (a) Specifications. Each pound of soluble powder contains 
chlortetracycline bisulfate equivalent to 102.4 grams (g) of 
chlortetracycline hydrochloride and sulfamethazine bisulfate equivalent 
to 102.4 g of sulfamethazine.
    (b) Sponsor. See No. 016592 in Sec. 510.600(c) of this chapter.
    (c) Related tolerances. See Sec. Sec. 556.150 and 556.670 of this 
chapter.
    (d) Conditions of use in swine. Administer in drinking water as 
follows:
    (1) Amount. 250 milligrams (mg) of chlortetracycline and 250 mg of 
sulfamethazine per gallon.
    (2) Indications for use. For the prevention and treatment of 
bacterial enteritis; as an aid in the reduction of the incidence of 
cervical abscesses; and as an aid in the maintenance of weight gains in 
the presence of bacterial enteritis and atrophic rhinitis.
    (3) Limitations. Use as the sole source of chlortetracycline and 
sulfonamide. Not to be used for more than 28 consecutive days. Withdraw 
15 days before slaughter. Federal law restricts this drug to use by or 
on the order of a licensed veterinarian.

[76 FR 49649, Aug. 11, 2011, as amended at 81 FR 17607, Mar. 30, 2016; 
81 FR 94989, Dec. 27, 2016]



Sec. 520.446  Clindamycin capsules and tablets.

    (a) Specifications. (1) Each capsule contains the equivalent of 25, 
75, 150, or 300 milligrams (mg) clindamycin as the hydrochloride salt.
    (2) Each tablet contains the equivalent of 25, 75, or 150 mg 
clindamycin as the hydrochloride salt.
    (3) Each capsule contains the equivalent of 25, 75, or 150 mg 
clindamycin as the hydrochloride salt.
    (b) Sponsors. See sponsors in Sec. 510.600(c) of this chapter as 
follows:
    (1) Nos. 054771 and 069043 for use of capsules described in 
paragraph (a)(1) of this section.
    (2) No. 051311 for use of tablets described in paragraph (a)(2) of 
this section.
    (3) No. 043806 for use of tablets described in paragraph (a)(3) of 
this section.
    (c) Conditions of use in dogs--(1) Amount. Wounds, abscesses, and 
dental infections: 2.5 to 15 mg per pound (/lb) body weight every 12 
hours for a maximum of 28 days. Osteomyelitis: 5.0 to 15 mg/lb body 
weight every 12 hours for a minimum of 28 days.
    (2) Indications for use. For the treatment of skin infections 
(wounds and abscesses) due to susceptible strains of coagulase-positive 
staphylococci (Staphylococcus aureus or S. intermedius), deep wounds and 
abscesses due to susceptible strains of Bacteroides fragilis, Prevotella 
melaninogenicus, Fusobacterium necrophorum, and Clostridium perfringens, 
dental infections due to susceptible strains of S. aureus, B. fragilis, 
P. melaninogenicus, F. necrophorum, and C. perfringens, and 
osteomyelitis due to susceptible strains of S. aureus, B. fragilis, P. 
melaninogenicus, F. necrophorum, and C. perfringens.

[[Page 175]]

    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[67 FR 54954, Aug. 27, 2002, as amended at 68 FR 55824, Sept. 29, 2003; 
69 FR 32273, June 9, 2004; 71 FR 39204, July 12, 2006; 73 FR 4077, Jan. 
24, 2008; 78 FR 17596, Mar. 22, 2013; 79 FR 28819, May 20, 2014; 80 FR 
76386, Dec. 9, 2015; 81 FR 17607, Mar. 30, 2016]



Sec. 520.447  Clindamycin solution.

    (a) Specifications. Each milliliter of solution contains the 
equivalent of 25 milligrams (mg) clindamycin as the hydrochloride salt.
    (b) Sponsors. See Nos. 051311, 054771, 058829, 061133, and 069043 in 
Sec. 510.600(c) of this chapter.
    (c) Special considerations. Federal law restricts this drug to use 
by or on the order of a licensed veterinarian.
    (d) Conditions of use--(1) Dogs--(i) Amount. Wounds, abscesses, and 
dental infections: 2.5 to 15 mg per pound (/lb) body weight every 12 
hours for a maximum of 28 days. Osteomyelitis: 5.0 to 15 mg/lb body 
weight every 12 hours for a minimum of 28 days.
    (ii) Indications for use. For the treatment of skin infections 
(wounds and abscesses) due to susceptible strains of coagulase-positive 
staphylococci (Staphylococcus aureus or S. intermedius), deep wounds and 
abscesses due to susceptible strains of Bacteroides fragilis, Prevotella 
melaninogenicus, Fusobacterium necrophorum, and Clostridium perfringens; 
dental infections due to susceptible strains of S. aureus, B. fragilis, 
P. melaninogenicus, F. necrophorum, and C. perfringens; and 
osteomyelitis due to susceptible strains of S. aureus, B. fragilis, P. 
melaninogenicus, F. necrophorum, and C. perfringens.
    (2) Cats--(i) Amount. 5.0 to 15.0 mg/lb body weight every 24 hours 
for a maximum of 14 days.
    (ii) Indications for use. For the treatment of skin infections 
(wounds and abscesses) due to susceptible strains of Staphylococcus 
aureus, S. intermedius, Streptococcus spp.; deep wounds and abscesses 
due to susceptible strains of Clostridium perfringens and Bacteroides 
fragilis; and dental infections due to susceptible strains of S. aureus, 
S. intermedius, Streptococcus spp., C. perfringens, and B. fragilis.

[67 FR 54954, Aug. 27, 2002, as amended at 67 FR 78684, Dec. 26, 2002; 
68 FR 55824, Sept. 29, 2003; 69 FR 31734, June 7, 2004; 71 FR 39543, 
July 13, 2006; 72 FR 19796, Apr. 20, 2007; 78 FR 17596, Mar. 22, 2013; 
78 FR 30197, May 22, 2013; 79 FR 28819, May 20, 2014; 81 FR 17607, Mar. 
30, 2016; 84 FR 8972, Mar. 13, 2019]



Sec. 520.452  Clenbuterol syrup.

    (a) Specifications. Each milliliter contains 72.5 micrograms of 
clenbuterol hydrochloride.
    (b) Sponsor. See 000010 in Sec. 510.600(c) of this chapter.
    (c) [Reserved]
    (d) Conditions of use--(1) Horses--(i) Amount. Administer orally 
twice a day (b.i.d.). Initial dose is 0.5 milliliter per 100 pounds body 
weight (0.8 micrograms per kilogram) for 3 days (6 treatments). If no 
improvement, administer 1 milliliter per 100 pounds (1.6 micrograms per 
kilogram) for 3 days (6 treatments). If no improvement, administer 1.5 
milliliters per 100 pounds (2.4 micrograms per kilogram) for 3 days (6 
treatments). If no improvement, administer 2.0 milliliters per 100 
pounds (3.2 micrograms per kilogram) for 3 days (6 treatments). If no 
improvement, horse is nonresponder to clenbuterol and treatment should 
be discontinued.
    (ii) Indications for use. Indicated for the management of horses 
affected with airway obstruction, such as occurs in chronic obstructive 
pulmonary disease (COPD).
    (iii) Limitations. Treat at effective dose for 30 days. At the end 
of the 30-day treatment period, drug should be withdrawn. If signs 
return, the 30-day treatment period may be repeated. If repeating 
treatment, the step-wise dosage schedule should be repeated. The effect 
of this drug on breeding stallions and brood mares has not been 
determined. Treatment starting with dosages higher than the initial dose 
is not recommended. Federal law prohibits the extralabel use of this 
drug in food animals. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.
    (2) [Reserved]

[63 FR 41419, Aug. 4, 1998]

[[Page 176]]



Sec. 520.455  Clomipramine tablets.

    (a) Specifications. Each tablet contains 5, 20, 40, or 80 milligrams 
(mg) clomipramine hydrochloride.
    (b) Sponsor. See Nos. 058198 and 086039 in Sec. 510.600(c) of this 
chapter.
    (c) Conditions of use--(1) Amount. 2 to 4 milligrams of clomipramine 
hydrochloride per kilogram (0.9 to 1.8 milligrams per pound) of body 
weight per day, administered as a single daily dose or divided twice 
daily.
    (2) Indications for use. For use as part of a comprehensive 
behavioral management program to treat separation anxiety in dogs 
greater than 6 months of age.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[64 FR 1762, Jan. 12, 1999, as amended at 72 FR 262, Jan. 4, 2007; 85 FR 
18119, Apr. 1, 2020]



Sec. 520.462  Clorsulon drench.

    (a) Specifications. The drug is a suspension containing 8.5 percent 
clorsulon (85 milligrams per milliliter).
    (b) Sponsor. See No. 000010 in Sec. 510.600(c) of this chapter.
    (c) Related tolerances. See Sec. 556.163 of this chapter.
    (d) Conditions of use. Cattle--(1) Amount. One-quarter fluid ounce 
per 200 pounds of body weight (7 milligrams per kilogram or 3.2 
milligrams per pound of body weight).
    (2) Indications for use. For the treatment of immature and adult 
liver fluke (Fasciola hepatica) infestations in cattle.
    (3) Limitations. Using dose syringe, deposit drench over back of 
tongue. Do not treat cattle within 8 days of slaughter. Because a 
withdrawal time in milk has not been established, do not use in female 
dairy cattle of breeding age. Consult your veterinarian for assistance 
in the diagnosis, treatment, and control of parasitism.

[50 FR 10221, Mar. 14, 1985, as amended at 62 FR 63270, Nov. 28, 1997; 
84 FR 32992, July 11, 2019; 84 FR 39183, Aug. 9, 2019]



Sec. 520.522  Cyclosporine.

    (a) Specifications. (1) Each cyclosporine capsule, USP (MODIFIED) 
contains 10, 25, 50, or 100 milligrams (mg) cyclosporine.
    (2) Each milliliter of cyclosporine oral solution, USP (MODIFIED) 
contains 100 mg cyclosporine.
    (b) Sponsors. See sponsors in Sec. 510.600(c) of this chapter.
    (1) No. 058198 for use of products described in paragraph (a) as in 
paragraph (d) of this section.
    (2) No. 026637 for use of product described in paragraph (a)(1) as 
in paragraph (d)(1) of this section.
    (3) No. 051311 for use of product described in paragraph (a)(2) of 
this section as in paragraph (d)(1) of this section.
    (c) [Reserved]
    (d) Conditions of use--(1) Dogs. Use capsules described in paragraph 
(a)(1) of this section as follow:
    (i) Amount. Administer 5 mg per kilogram (mg/kg) of body weight 
given orally as a single daily dose for 30 days. Following this initial 
daily treatment period, the dosage may be tapered by decreasing the 
frequency of administration to every other day or two times a week, 
until a minimum frequency is reached which will maintain the desired 
therapeutic effect.
    (ii) Indications for use. For the control of atopic dermatitis in 
dogs weighing at least 4 pounds.
    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.
    (2) Cats. Use the solution described in paragraph (a)(2) of this 
section as follow:
    (i) Amount. Administer 7 mg/kg of body weight orally as a single 
daily dose for a minimum of 4 to 6 weeks or until resolution of clinical 
signs. Following this initial daily treatment period, the dosage may be 
tapered by decreasing the frequency of administration to every other day 
or twice weekly to maintain the desired therapeutic effect.
    (ii) Indications for use. For the control of feline allergic 
dermatitis in cats at least 6 months of age and weighing at least 3 
pounds.
    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

[68 FR 54804, Sept. 19, 2003, as amended at 76 FR 78815, Dec. 20, 2011; 
84 FR 12493, Apr. 2, 2019; 86 FR 17063, Apr. 1, 2021]

[[Page 177]]



Sec. 520.530  Cythioate oral liquid.

    (a) Specifications. Each milliliter contains 15 milligrams of 
cythioate.
    (b) Sponsor. See Nos. 054771 and 058198 in Sec. 510.600 of this 
chapter.
    (c) Special considerations. Cythioate is a cholinesterase inhibitor. 
Do not use this product in animals simultaneously with or within a few 
days before or after treatment with or exposure to cholinesterase-
inhibiting drugs, insecticides, pesticides, or chemicals.
    (d) Conditions of use--(1) Amount. 15 milligrams cythioate per 10 
pounds of body weight every third day or twice a week.
    (2) Indications for use. Dogs, for control of fleas.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[49 FR 5614, Feb. 14, 1984, as amended at 67 FR 78355, Dec. 24, 2002; 79 
FR 28819, May 20, 2014; 86 FR 14818, Mar. 19, 2021]



Sec. 520.531  Cythioate tablets.

    (a) Specifications. Each tablet contains 30 or 90 milligrams (mg) 
cythioate.
    (b) Sponsors. See sponsor numbers in Sec. 510.600(c) of this 
chapter as follows:
    (1) No. 058198 for use of 30- and 90-mg tablets.
    (2) No. 054771 for use of the 30-mg tablet.
    (c) Conditions of use--(1) Amount. 30 milligrams cythioate per 20 
pounds of body weight every third day or twice a week.
    (2) Indications for use. Dogs, for control of fleas.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[49 FR 5615, Feb. 14, 1984, as amended at 59 FR 26942, May 25, 1994; 67 
FR 78355, Dec. 24, 2002; 79 FR 28819, May 20, 2014; 86 FR 14818, Mar. 
19, 2021]



Sec. 520.534  Decoquinate.

    (a) Specifications. Each gram of powder contains 8 milligrams (0.8 
percent) decoquinate.
    (b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
    (c) Related tolerances. See Sec. 556.170 of this chapter.
    (d) Conditions of use. Calves--(1) Amount. Feed 22.7 milligrams per 
100 pounds of body weight (0.5 milligram per kilogram) per day.
    (2) Indications for use. For the prevention of coccidiosis in 
ruminating and nonruminating calves, including veal calves, caused by 
Eimeria bovis and E. zuernii.
    (3) Limitations. Feed in whole milk at the rate of 22.7 milligrams 
per 100 pounds body weight daily (0.5 milligram per kilogram) for at 
least 28 days.

[64 FR 10103, Mar. 2, 1999, as amended at 64 FR 30386, June 8, 1999; 79 
FR 28819, May 20, 2014]



Sec. 520.538  Deracoxib.

    (a) Specifications. Each tablet contains 12, 25, 50, 75, or 100 
milligrams (mg) deracoxib.
    (b) Sponsor. See Nos. 013744 and 058198 in Sec. 510.600(c) of this 
chapter.
    (c) [Reserved]
    (d) Conditions of use in dogs--(1) Amount. Administer orally as 
needed, as a single daily dose based on body weight:
    (i) 1 to 2 mg/kilogram (kg) (0.45 to 0.91 mg/pound (lb)), for use as 
in paragraph (d)(2)(i) of this section.
    (ii) 1 to 2 mg/kg (0.45 to 0.91 mg/lb) for 3 days, for use as in 
paragraph (d)(2)(ii) of this section.
    (iii) 3 to 4 mg/kg (1.4 to 1.8 mg/lb) for up to 7 days, for use as 
in paragraph (d)(2)(iii) of this section.
    (2) Indications for use. (i) For the control of pain and 
inflammation associated with osteoarthritis.
    (ii) For the control of postoperative pain and inflammation 
associated with dental surgery.
    (iii) For the control of postoperative pain and inflammation 
associated with orthopedic surgery.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[67 FR 68760, Nov. 13, 2002, as amended at 68 FR 18882, Apr. 17, 2003; 
72 FR 37437, July 10, 2007; 73 FR 33692, June 13, 2008; 77 FR 3928, Jan. 
26, 2012; 84 FR 39183, Aug. 9, 2019]

[[Page 178]]



Sec. 520.540  Dexamethasone oral dosage forms.



Sec. 520.540a  Dexamethasone powder.

    (a) Specifications. Each packet contains 10 milligrams (mg) of 
dexamethasone.
    (b) Sponsor. See No. 000061 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in cattle and horses--(1) Amount. Administer 5 
to 10 mg per animal the first day then 5 mg per day as required by 
drench or by sprinkling on a small amount of feed.
    (2) Indications for use. As supportive therapy following parenteral 
steroid administration for management or inflammatory conditions such as 
acute arthritic lameness, and for various stress conditions where 
corticosteroids are required while the animal is being treated for a 
specific condition.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian. A withdrawal period has not been 
established for this product in preruminating calves. Do not use in 
calves to be processed for veal. Do not use in horses intended for human 
consumption.

[79 FR 28819, May 20, 2014]



Sec. 520.540b  Dexamethasone tablets and boluses.

    (a)(1) Specifications. Each bolus is half-scored and contains 10 
milligrams of dexamethasone.
    (2) Sponsor. See No. 000061 in Sec. 510.600(c) of this chapter.
    (3) Conditions of use in cattle and horses--(i) Amount. Administer 
orally 5 to 10 milligrams on the first day, then 5 milligrams per day as 
required.
    (ii) Indications for use. As supportive therapy following parenteral 
steroid administration for management or inflammatory conditions such as 
acute arthritic lameness, and for various stress conditions where 
corticosteroids are required while the animal is being treated for a 
specific condition.
    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian. A withdrawal period has not been 
established for this product in preruminating calves. Do not use in 
calves to be processed for veal. Do not use in horses intended for human 
consumption.
    (b)(1) Specifications. Each tablet contains 0.25 milligram of 
dexamethasone.
    (2) Sponsors. See Nos. 000061 and 061133 in Sec. 510.600(c) of this 
chapter.
    (3) Conditions of use in dogs and cats--(i) Amount. Dogs: Administer 
orally 0.25 to 1.25 milligrams per day for up to 7 days. Cats: 
Administer orally 0.125 to 0.5 milligrams per day for up to 7 days.
    (ii) Indications for use. As an anti-inflammatory agent.
    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

[40 FR 26273, June 23, 1975, as amended at 44 FR 7130, Feb. 6, 1979; 50 
FR 49372, Dec. 2, 1985; 52 FR 7832, Mar. 13, 1987; 55 FR 8461, Mar. 8, 
1990; 66 FR 14073, Mar. 9, 2001; 68 FR 4914, Jan. 31, 2003; 70 FR 16934, 
Apr. 4, 2005; 79 FR 28819, May 20, 2014; 84 FR 8972, Mar. 13, 2019]



Sec. 520.540c  Dexamethasone chewable tablets.

    (a) Specifications. Each half-scored tablet contains 0.25 milligram 
of dexamethasone.
    (b) Sponsor. See No. 051031 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in dogs--(1) Amount. Administer by free-choice 
feeding or crumbled over food 0.25 to 1.25 milligrams daily in single or 
two divided doses until response is noted or 7 days have elapsed. When 
response is attained, dosage should be gradually reduced by 0.125 
milligram per day until maintenance level is achieved.
    (2) Indications for use. As supportive therapy in nonspecific 
dermatosis and inflammatory conditions.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[44 FR 7130, Feb. 6, 1979, as amended at 56 FR 50653, Oct. 8, 1991; 60 
FR 55659, Nov. 2, 1995; 79 FR 28820, May 20, 2014; 82 FR 11508, Feb. 24, 
2017]



Sec. 520.563  Dexamethasone chewable tablets.

    (a) Specifications. Diatrizoate meglumine oral solution is a water 
soluble radiopaque medium containing 66 percent diatrizoate meglumine 
and 10 percent diatrizoate sodium.
    (b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in dogs and cats--(1) Amount. Administer 
orally 0.5 to 1.0

[[Page 179]]

milliliter per pound of body weight by gavage or stomach tube. 
Administered rectally 0.5 to 1.0 milliliter per pound of body weight 
diluted with 1 part of the drug to 5 parts of water.
    (2) Indications for use. For radiography of the gastrointestinal 
tract.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[44 FR 12993, Mar. 9, 1979, as amended at 50 FR 41489, Oct. 11, 1985; 79 
FR 28820, May 20, 2014]



Sec. 520.580  Dichlorophene and toluene.

    (a) Specifications. Each capsule contains 50 milligrams (mg) of 
dichlorophene and 60 mg of toluene, or multiples thereof.
    (b) Sponsors. See sponsors in Sec. 510.600(c) of this chapter for 
use as in paragraph (c) of this section:
    (1) Nos. 017135 and 023851 for use only as a single dose.
    (2) Nos. 000061, 054771, and 069043 for use in a single dose or 
divided-dosage regimen.
    (c) Required statement. Consult your veterinarian for assistance in 
the diagnosis, treatment, and control of parasitism, and before 
administering to weak or debilitated animals.
    (d) Conditions of use--(1) Amount. Administer as follows:
    (i) Single dose: Administer 100 mg of dicholorophene and 120 mg of 
toluene per pound of body weight.
    (ii) Divided dose: Administer 100 mg of dichlorophene and 120 mg of 
toluene per 5 pounds of body weight (20 and 24 mg per pound) daily for 6 
days.
    (2) Indications for use. For the removal of ascarids (Toxocara canis 
and Toxascaris leonina) and hookworms (Ancylostoma caninum and Uncinaria 
stenocephala); and as an aid in removing tapeworms (Taenia pisiformis, 
Dipylidium caninum, and Echinococcus granulosus) from dogs and cats.
    (3) Limitations. Withhold solid foods and milk for at least 12 hours 
prior to medication and for 4 hours afterward. Repeat treatment in 2 to 
4 weeks in animals subject to reinfection.

[45 FR 10332, Feb. 15, 1980]

    Editorial Note: For Federal Register citations affecting Sec. 
520.580, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and at www.govinfo.gov.



Sec. 520.581  Dichlorophene tablets.

    (a) Specifications. Each tablet contains 1 gram of dichlorophene.
    (b) Sponsor. See 023851 in Sec. 510.600(c) of this chapter.
    (c) Required statement. Consult your veterinarian for assistance in 
the diagnosis, treatment, and control of parasitism, and before 
administering to weak or debilitated animals.
    (d) Conditions of use. Dogs--(1) Amount. Single dose of 1 tablet (1 
gram of dichlorophene) for each 10 pounds of body weight.
    (2) Indications for use. It is used as an aid in the removal of 
tapeworms (Taenia pisiformis and Dipylidium caninum).
    (3) Limitations. Withhold solid foods and milk for at least 12 hours 
prior to medication and for 4 hours afterward.

[45 FR 10333, Feb. 15, 1980]



Sec. 520.596  Dichlorvos powder.

    (a) Specifications--(1) Each 2-ounce packet contains 2.27 grams (4 
percent) dichlorvos.
    (2) Each milligram of powder contains 2.27 milligrams (mg) 
dichlorvos.
    (b) Sponsor. See No. 069043 in Sec. 510.600(c) of this chapter for 
use of the product described in paragraph (a)(1) of this section as in 
paragraph (d)(1) of this section and the product described in paragraph 
(a)(2) of this section as in paragraph (d)(2) of this section.
    (c) Related tolerances. See Sec. 556.180 of this chapter.
    (d) Conditions of use--(1) Swine (adult gilts, sows, and boars)--(i) 
Amount. Add powder to the indicated amount of feed and administered 
shortly after mixing, as follows:

----------------------------------------------------------------------------------------------------------------
                                                                             Pounds of mixed
                                                         Pounds of feed to      feed to be       Number of pigs
               Weight of animal in pounds                   be mixed with    administered to     to be treated
                                                          each 0.08  ounce    each pig as a     per 0.08  ounce
                                                           of  dichlorvos    single treatment    of  dichlorvos
----------------------------------------------------------------------------------------------------------------
20-30..................................................                  4               0.33                 12

[[Page 180]]

 
31-40..................................................                  5               0.56                  9
41-60..................................................                  6               1.00                  6
61-80..................................................                  5               1.00                  5
81-100.................................................                  4               1.00                  4
                                                                        16               4.00                  4
----------------------------------------------------------------------------------------------------------------

    (ii) Indications for use. For the removal and control of sexually 
mature (adult), sexually immature and/or 4th stage larvae of the 
whipworm (Trichuris suis), nodular worms (Oesophagostomum spp.), large 
round-worm (Ascaris suum), and the mature thick stomach worm (Ascarops 
strongylina) occurring in the lumen of the gastrointestinal tract of 
pigs, boars, and open or bred gilts and sows.
    (iii) Limitations. Do not use this product on animals either 
simultaneously or within a few days before or after treatment with or 
exposure to cholinesterase inhibiting drugs, pesticides, or chemicals. 
The preparation should be mixed thoroughly with the feed on a clean, 
impervious surface. Do not allow swine access to feed other than that 
containing the preparation until treatment is complete. Do not treat 
pigs with signs of scours until these signs subside or are alleviated by 
proper medication. Resume normal feeding schedule afterwards. Swine may 
be retreated in 4 to 5 weeks.
    (2) Horses--(i) Amount. Administer in the grain portion of the 
ration at a dosage of 14.2 to 18.5 mg per pound of body weight as a 
single dose. Administered at one-half of the single recommended dosage 
and repeated 8 to 12 hours later in the treatment of very aged, 
emaciated, or debilitated subjects or those reluctant to consume 
medicated feed. In suspected cases of severe ascarid infection 
sufficient to cause concern over mechanical blockage of the intestinal 
tract, the split dosage should be used.
    (ii) Indications for use. For the removal and control of bots 
(Gastrophilus intestinalis, G. nasalis), large strongyles (Strongylus 
vulgaris, S. equinus, S. edentatus), small strongyles (of the genera 
Cyathostomum, Cylicocercus, Cylicocyclus, Cylicodontophorus, 
Triodontophorus, Poteriostomum, Gyalocephalus), pinworms (Oxyuris equi), 
and large roundworm (Parascaris equorum) in horses including ponies and 
mules. Not for use in foals (sucklings and young weanlings).
    (iii) Limitations. Do not use in horses which are severely 
debilitated, suffering from diarrhea or severe constipation, infectious 
disease, toxemia, or colic. Do not administer in conjunction with or 
within 1 week of administration of muscle relaxant drugs, phenothiazine 
derived tranquilizers or central nervous system depressant drugs. Horses 
should not be subjected to insecticide treatment for 5 days prior to or 
after treating with the drug. Do not administer to horses afflicted with 
chronic alveolar emphysema (heaves) or related respiratory conditions. 
The product is a cholinesterase inhibitor and should not be used 
simultaneously or within a few days before or after treatment with or 
exposure to cholinesterase inhibiting drugs, pesticides or chemicals. Do 
not use in animals other than horses, ponies, and mules. Do not use in 
horses, ponies, and mules intended for food purposes. Do not allow fowl 
access to feed containing this preparation or to fecal excrement from 
treated animals.

[83 FR 48944, Sept. 28, 2018]



Sec. 520.598  Dichlorvos tablets.

    (a) Specifications. Each tablet contains 2, 5, 10, or 20 milligrams 
(mg) dichlorvos.
    (b) Sponsor. See No. 069043 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in dogs, puppies, cats, and kittens--(1) 
Amount. Administer orally at 5 mg dichlorvos per pound of body weight.
    (2) Indications for use--(i) Dogs and puppies: Removal and control 
of intestinal roundworms (Toxocara canis and Toxascaris leonina) and 
hookworms

[[Page 181]]

(Ancylostoma caninum and Uncinaria stenocephala).
    (ii) Cats and kittens: Removal and control of intestinal roundworms 
(Toxocara cati and Toxascaris leonina) and hookworms (Ancylostoma 
tubaeforme and Uncinaria stenocephala).
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[83 FR 48945, Sept. 28, 2018]



Sec. 520.600  Dichlorvos capsules and pellets.

    (a) Specifications. Each capsule contains 2.27 milligrams (mg) (4 
percent) dichlorvos.
    (b) Sponsor. See No. 069043 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in dogs--(1) Amount. Administer any 
combination of capsules and/or pellets so that the animal receives a 
single dose equaling 12 to 15 mg of dichlorvos per pound of body weight.
    (2) Indications for use. For removal of Toxocara canis and 
Toxascaris leonina (roundworms), Ancylostoma caninum and Uncinaria 
stenocephala (hookworms), and Trichuris vulpis (whipworm) residing in 
the lumen of the gastrointestinal tract.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[83 FR 48945, Sept. 28, 2018]



Sec. 520.602  Dichlorvos gel.

    (a) Specifications. Each milligram (mg) of gel contains 2.27 
milligrams (mg) dichlorvos.
    (b) Sponsor. See No. 069043 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in horses--(1) Amount. Administer 20 mg per 
kilogram of body weight for the removal of bots and ascarids. Repeat 
administration every 21 to 28 days for the control of bots and ascarids. 
For the control of bots only, the repeat dosage is 10 milligrams per 
kilogram of body weight every 21 to 28 days during bot fly season.
    (2) Indications for use. For the removal and control of first, 
second, and third instar bots (Gastrophilus intestinalis and G. 
nasalis), sexually mature and sexually immature (4th stage) ascarids 
(Parascaris equorum) in horses and foals.
    (3) Limitations. Do not use in horses intended for human 
consumption. Federal law restricts this drug to use by or on the order 
of a licensed veterinarian.

[83 FR 48945, Sept. 28, 2018]



Sec. 520.606  Diclazuril.

    (a) Specifications. Each 100 grams (g) of pellets contain 1.56 g 
diclazuril.
    (b) Sponsor. See No. 000061 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in horses--(1) Amount. Administer 1 milligram 
(mg) per kilogram (0.45 mg per pound) of body weight in the daily grain 
ration for 28 days.
    (2) Indications for use. For the treatment of equine protozoal 
myeloencephalitis (EPM) caused by Sarcocystis neurona.
    (3) Limitations. Do not use in horses intended for human 
consumption. Federal law restricts this drug to use by or on the order 
of a licensed veterinarian.

[72 FR 20943, Apr. 27, 2007]



Sec. 520.608  Dicloxacillin.

    (a) Specifications. Each capsule contains dicloxacillin sodium 
monohydrate equivalent to 50, 100, 200, or 500 milligrams of 
dicloxacillin.
    (b) Sponsor. See No. 054771 in Sec. 510.600 (c) of this chapter.
    (c) Conditions of use in dogs--(1) Amount. Administer orally 5 to 10 
milligrams per pound of body weight, three times daily. In severe cases, 
up to 25 milligrams per pound of body weight three times daily.
    (2) Indications for use. For the treatment of pyoderma (pyogenic 
dermatitis) due to penicillinase-producing staphylococci sensitive to 
dicloxacillin.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[57 FR 37325, Aug. 18, 1992, as amended at 79 FR 28820, May 20, 2014]

[[Page 182]]



Sec. 520.620  Diethylcarbamazine oral dosage forms.



Sec. 520.622  Diethylcarbamazine citrate oral dosage forms.



Sec. 520.622a  Diethylcarbamazine citrate tablets.

    (a) Sponsors. (1) [Reserved]
    (2) See 054771 in Sec. 510.600(c) of this chapter for use of 100, 
200, and 300 milligram tablets for prevention of heartworm disease in 
dogs and as an aid in the treatment of ascarid infections in dogs.
    (3) See 061133 in Sec. 510.600(c) of this chapter for use of 50, 
100, 200, 300, or 400 milligram tablets for prevention of heartworm 
disease in dogs, as an aid in the control of ascarid infections in dogs, 
and as an aid in the treatment of ascarid infections in dogs and cats.
    (4) [Reserved]
    (5) See No. 000061 in Sec. 510.600(c) of this chapter for use of 
60, 120, or 180 milligram tablets for prevention of heartworm disease in 
dogs, as an aid in the control of ascarid infections in dogs, and as an 
aid in the treatment of ascarid infections in dogs and cats.
    (6) See No. 069043 in Sec. 510.600(c) of this chapter for use of 
50, 100, 200, 300, or 400 milligram tablets for prevention of heartworm 
disease in dogs, as an aid in the control of ascarid infections in dogs, 
and as an aid in the treatment of ascarid infections in dogs and cats.
    (b) Conditions of use--(1) Dosage/indications for use. (i) Three 
milligrams per pound of body weight daily for prevention of heartworm 
disease (Dirofilaria immitis) in dogs.
    (ii) Three milligrams per pound of body weight daily as an aid in 
the control of ascarid infections (Toxocara canis) in dogs.
    (iii) Twenty-five to 50 milligrams per pound of body weight as an 
aid in the treatment of ascarid infections in dogs (Toxocara canis) and 
cats (Toxocara canis and Toxascaris leonina).
    (2) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[46 FR 23230, Apr. 24, 1981, as amended at 46 FR 41038, Aug. 14, 1981; 
46 FR 46315, Sept. 18, 1981; 46 FR 61653, Dec. 18, 1981; 47 FR 10805, 
Mar. 12, 1982; 47 FR 14150, Apr. 2, 1982; 50 FR 41489, Oct. 11, 1985; 50 
FR 49372, Dec. 2, 1985; 53 FR 40056, Oct. 13, 1988; 53 FR 40727, Oct. 
18, 1988; 55 FR 8461, Mar. 8, 1990; 61 FR 34728, July 3, 1996; 62 FR 
35076, June 30, 1997; 66 FR 14073, Mar. 9, 2001; 68 FR 4914, Jan. 31, 
2003; 76 FR 17777, Mar. 31, 2011; 77 FR 4896, Feb. 1, 2012; 78 FR 21059, 
Apr. 7, 2013; 79 FR 28820, May 20, 2014; 83 FR 48945, Sept. 28, 2018; 84 
FR 8972, Mar. 13, 2019]



Sec. 520.622b  Diethylcarbamazine citrate syrup.

    (a)(1) Specifications. Each milliliter of syrup contains 60 
milligrams of diethylcarbamazine citrate.
    (2) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
    (3) Conditions of use. (i) The drug is indicated for use in dogs for 
the prevention of infection with Dirofilaria immitis and T. canis and T. 
leonina. It is also indicated for treatment of ascarid infections of T. 
canis and T. leonina in dogs and T. cati in cats.
    (ii) For prevention of heartworm and ascarid infections in dogs, the 
drug may be added to the daily diet at a dosage rate of 3.0 milligrams 
per pound of body weight per day or given directly by mouth at the same 
dosage rate. For treatment of ascarid infections in dogs and cats, the 
drug is administered at a dosage level of 25 to 50 milligrams per pound 
of body weight preferably administered immediately after feeding.
    (iii) Older dogs should be proven negative for the presence of 
Dirofilaria immitis infection before administration of the drug. Those 
with proven infection of Dirofilaria immitis should be rendered negative 
using adulticidal and microfilaricidal drugs before administration of 
this drug.
    (iv) Federal law restricts this drug to use by or on the order of a 
licensed veterinarian.
    (b) [Reserved]
    (c)(1) Specifications. Each milliliter of syrup contains 60 
milligrams of diethylcarbamazine citrate.
    (2) Sponsor. See No. 069043 in Sec. 510.600(c) of this chapter.

[[Page 183]]

    (3) Conditions of use. (i) The drug is used in dogs between 4 weeks 
and 8 months of age for the removal of ascarids (Toxacara canis) and in 
animals over 4 weeks of age for the prevention of heartworm disease 
(Dirofilaria immitis).
    (ii) The drug is administered (a) for removal of ascarids at a 
dosage of 50 milligrams per pound of body weight divided into two equal 
doses and administered 8 to 12 hours apart (morning and night), orally 
or mixed with either dry or wet food, and (b) for prevention of 
heartworm disease at a dosage of 3 milligrams per pound of body weight 
daily, orally or in food, in heartworm endemic areas, from the beginning 
of mosquito activity, during the mosquito season, and for 2 months 
following the end thereof.
    (iii) Dogs older than 8 months of age may be infected with 
Dirofilaria immitis. Use of the drug is contraindicated in dogs with 
active D. immitis infections.
    (iv) Federal law restricts this drug to use by or on the order of a 
licensed veterinarian.

[40 FR 13838, Mar. 27, 1975, as amended at 41 FR 28265, July 9, 1976; 44 
FR 3967, Jan. 19, 1979; 47 FR 14150, Apr. 2, 1982; 47 FR 35186, Aug. 13, 
1982; 49 FR 33997, Aug. 28, 1984; 50 FR 41489, Oct. 11, 1985; 53 FR 
47027, Oct. 18, 1988; 61 FR 34728, July 3, 1996; 62 FR 35076, June 30, 
1997; 62 FR 38906, July 21, 1997; 77 FR 4897, Feb. 1, 2012; 78 FR 21059, 
Apr. 9, 2013; 79 FR 28820, May 20, 2014; 83 FR 48945, Sept. 28, 2018]



Sec. 520.622c  Diethylcarbamazine citrate chewable tablets.

    (a) Specifications. Each chewable tablet contains 30, 45, 60, 120, 
150, or 180 milligrams of diethylcarbamazine citrate.
    (b) Sponsors. See drug listing nos. in Sec. 510.600(c) of this 
chapter for identification of sponsors as follows:
    (1) [Reserved]
    (2) For 054771, use of 60, 120, or 180 milligram tablets as in 
paragraph (c)(2)(ii) of this section.
    (3) For 061690, use of 45 or 150 milligram tablets as in paragraph 
(c)(2)(iii) of this section.
    (4) For 061133, use of 60-, 120-, or 180-milligram tablets as in 
paragraph (c)(2)(i) of this section.
    (5) For 000061, use of 60-milligram tablets as in paragraph 
(c)(2)(i) of this section.
    (6) For 069043, use of 30, 60, 120, or 180 milligram tablets as in 
paragraph (c)(2)(i) of this section.
    (c) Conditions of use--(1) Amount. 3 milligrams per pound of body 
weight per day for prevention of heartworm disease and control of 
ascarids; 25 to 50 milligrams per pound of body weight as an aid in 
treatment of ascarid infections.
    (2) Indications for use. (i) For prevention of heartworm disease 
(Dirofilaria immitis) in dogs; as an aid in control of ascarids 
(Toxocara canis) in dogs; as an aid in treatment of ascarid (Toxocara 
canis and Toxascaris leonina) infections in dogs and cats.
    (ii) For prevention of infection with Dirofilaria immitis (heartworm 
disease) in dogs; as an aid in treatment of ascarid (Toxocara canis and 
Toxascaris leonina) infections in dogs.
    (iii) For prevention of heartworm disease (Dirofilaria immitis) in 
dogs.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[43 FR 6941, Feb. 17, 1978]

    Editorial Note: For Federal Register citations affecting Sec. 
520.622c, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and at www.govinfo.gov.



Sec. 520.623  Diethylcarbamazine and oxibendazole chewable tablets.

    (a) Specifications. Each tablet contains either 60, 120, or 180 
milligrams of diethylcarbamazine citrate with 45, 91, or 136 milligrams 
of oxibendazole, respectively.
    (b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in dogs--(1) Amount. Administer orally to dogs 
at a dosage level of 6.6 milligrams of diethylcarbamazine citrate per 
kilogram of body weight (3 milligrams per pound of body weight) and 5.0 
milligrams of oxibendazole per kilogram of body weight (2.27 milligrams 
per pound of body weight).
    (2) Indications for use. For prevention of infection with 
Dirofilaria immitis (heartworm disease) and Ancylostoma caninum 
(hookworm infection) and for removal and control of Trichuris vulpis 
(whipworm infection) and mature and

[[Page 184]]

immature stages of intestinal Toxocara canis (ascarid infection).
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[50 FR 28768, July 16, 1985, as amended at 53 FR 45759, Nov. 14, 1988; 
54 FR 3776, Jan. 26, 1989; 54 FR 6804, Feb. 14, 1989; 56 FR 50653, Oct. 
8, 1991; 60 FR 55659, Nov. 2, 1995; 79 FR 28820, May 20, 2014]



Sec. 520.645  Difloxacin.

    (a) Specifications. Each tablet contains 11.4, 45.4, or 136 
milligrams (mg) of difloxacin hydrochloride.
    (b) Sponsor. See No. 000010 in Sec. 510.600(c) of this chapter.
    (c) [Reserved]
    (d) Conditions of use--(i) Amount. Administer 5 to 10 mg per 
kilogram (2.3 to 4.6 mg per pound) of body weight orally once a day for 
2 to 3 days beyond cessation of clinical signs of disease up to a 
maximum of 30 days.
    (ii) Indications for use. For management of diseases in dogs 
associated with bacteria susceptible to difloxacin.
    (iii) Limitations. Federal law prohibits the extra-label use of this 
drug in food-producing animals. Federal law restricts this drug to use 
by or on the order of a licensed veterinarian.
    (2) [Reserved]

[63 FR 8123, Feb. 18, 1998, as amended at 75 FR 10165, Mar. 5, 2010]



Sec. 520.666  Dirlotapide.

    (a) Specifications. Each milliliter (mL) of solution contains 5 
milligrams (mg) dirlotapide.
    (b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in dogs--(1) Amount. The initial dosage is 
0.01 mL/kg (0.0045 mL/lb) body weight for the first 14 days. After the 
first 14 days of treatment, the dose volume is doubled to 0.02 mL/kg 
(0.009 mL/lb) body weight for the next 14 days (days 15 to 28 of 
treatment). Dogs should be weighed monthly and the dose volume adjusted 
every month, as necessary, to maintain a target percent weight loss 
until the desired weight is achieved.
    (2) Indications for use. For the management of obesity.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[72 FR 263, Jan. 4, 2007, as amended at 79 FR 28820, May 20, 2014]



Sec. 520.763  Dithiazanine oral dosage forms.



Sec. 520.763a  Dithiazanine tablets.

    (a) Specifications. Each tablet contains 10, 50, 100, or 200 
milligrams (mg) dithiazanine iodide.
    (b) Sponsor. See No. 069043 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in dogs--(1) Indications for use and amount. 
Administer orally immediately after feeding as follows:
    (i) For large roundworms (Toxocara canis, Toxascaris leonina): 10 mg 
per pound (/lb) of body weight for 3 to 5 days;
    (ii) For hookworms (Ancylostoma caninum, Uncinaria stenocephala) and 
whipworms (Trichuris vulpis): 10 mg/lb of body weight for 7 days;
    (iii) For Strongyloides (Strongyloides canis, Strongyloides 
stercoralis): 10 mg/lb of body weight for 10 to 12 days;
    (iv) For heartworm microfilariae (Dirofilaria immitus): 3 to 5 mg/lb 
of body weight for 7 to 10 days. Treatment for heartworm microfilariae 
should follow 6 weeks after therapy for adult worms.
    (2) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[79 FR 28820, May 20, 2014, as amended at 83 FR 48945, Sept. 28, 2018]



Sec. 520.763b  Dithiazanine powder.

    (a) Specifications. Each tablespoon of powder contains 200 
milligrams (mg) dithiazanine iodide.
    (b) Sponsor. See No. 069043 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in dogs--(1) Indications for use and amount. 
Administer orally by mixing in food as follows:
    (i) For large roundworms (Toxocara canis, Toxascaris leonina): 10 mg 
per pound (/lb) of body weight for 3 to 5 days;
    (ii) For hookworms (Ancylostoma caninum, Uncinaria stenocephala) and 
whipworms (Trichuris vulpis): 10 mg/lb of body weight for 7 days;

[[Page 185]]

    (iii) For Strongyloides (Strongyloides canis, Strongyloides 
stercoralis): 10 mg/lb of body weight for 10 to 12 days;
    (iv) For heartworm microfilariae (Dirofilaria immitus): 3 to 5 mg/lb 
of body weight for 7 to 10 days. Treatment for heartworm microfilariae 
should follow 6 weeks after therapy for adult worms.
    (2) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[79 FR 28820, May 20, 2014, as amended at 83 FR 48945, Sept. 28, 2018]



Sec. 520.763c  Dithiazanine iodide and piperazine citrate suspension.

    (a) Specifications. Each milliliter of suspension contains 69 
milligrams (mg) dithiazanine iodide and 83 mg piperazine base (as 
piperazine citrate).
    (b) Sponsor. See No. 069043 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in horses--(1) Amount. 1 ounce (30 
milliliters) per 100 pounds of body weight for the first 500 pounds; \3/
4\ ounce for each 100 pounds thereafter, up to 1,200 pounds; 10\1/4\ 
ounces to animals over 1,200 pounds.
    (2) Indications for use. For control of large roundworms, Parascaris 
equorum; small strongyles; large strongyles, Strongylus vulgaris; and 
pinworms, Oxyuris equi.
    (3) Limitations. Administer by drench or mixed with the daily ration 
as a single dose. Treatment is recommended in spring and fall. In a 
heavily infested environment, treatment may be repeated every 30 days. 
Not for use in horses intended for food purposes. Severely debilitated 
animals should not be wormed except on the advice of a veterinarian. If 
the drug is for administration by stomach tube, it shall be labeled: 
``Federal law restricts this drug to use by or on the order of a 
licensed veterinarian.''

[47 FR 52696, Nov. 23, 1982, as amended at 48 FR 32342, July 15, 1983; 
53 FR 40727, Oct. 18, 1988; 62 FR 35076, June 30, 1997; 78 FR 21059, 
Apr. 9, 2013; 79 FR 28820, May 20, 2014; 83 FR 48945, Sept. 28, 2018]



Sec. 520.766  Domperidone.

    (a) Specifications. Each milliliter of gel contains 110 milligrams 
(mg) domperidone.
    (b) Sponsor. See No. 043264 in Sec. 510.600 of this chapter.
    (c) Conditions of use in horses--(1) Amount. Administer 0.5 mg per 
pound (mg/lb) (1.1 mg/kilogram (kg)) by mouth once daily starting 10 to 
15 days prior to the expected foaling date. Treatment may be continued 
for up to 5 days after foaling if mares are not producing adequate milk.
    (2) Indications for use. For prevention of fescue toxicosis in 
periparturient mares.
    (3) Limitations. Do not use in horses intended for human 
consumption. Federal law restricts this drug to use by or on the order 
of a licensed veterinarian.

[75 FR 67031, Nov. 1, 2010]



Sec. 520.784  Doxylamine.

    (a) Specifications. The drug is in tablet form and contains 
doxylamine succinate as the active drug ingredient.
    (b) Sponsor. See No. 000061 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use--(1) Amount. Horses: Administer orally 1 to 2 
milligrams (mg) per pound (/lb) of body weight per day divided into 3 or 
4 equal doses. Dogs and cats: Administer orally 2 to 3 mg/lb of body 
weight per day divided into 3 or 4 equal doses.
    (2) Indications for use. For use when antihistaminic therapy may be 
expected to alleviate some signs of disease in horses, dogs, and cats.
    (3) Limitations. Do not use in horses intended for human 
consumption. Federal law restricts this drug to use by or on the order 
of a licensed veterinarian.

[40 FR 13838, Mar. 27, 1975, as amended at 42 FR 60140, Nov. 25, 1977; 
46 FR 48642, Oct. 2, 1981; 61 FR 8873, Mar. 6, 1996; 62 FR 61624, Nov. 
19, 1997; 79 FR 28821, May 20, 2014]



Sec. 520.804  Enalapril.

    (a) Specifications. Each tablet contains 1.0, 2.5, 5.0, 10, or 20 
milligrams (mg) of enalapril maleate.
    (b) Sponsor. See No. 000010 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in dogs--(1) Amount. Administer orally 0.5 to 
1.0 mg of enalapril maleate per kilogram of body weight per day.
    (2) Indications for use. For the treatment of mild, moderate, and 
severe (modified New York Heart Association Class II, III, IV) heart 
failure in dogs.

[[Page 186]]

    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[79 FR 28821, May 20, 2014, as amended at 80 FR 34278, June 16, 2015; 84 
FR 39183, Aug. 9, 2019]



Sec. 520.812  Enrofloxacin.

    (a) Specifications. (1) Each tablet contains:
    (i) 22.7, 68.0, or 136.0 milligrams (mg) enrofloxacin; or
    (ii) 22.7, 68.0, 136.0, or 272 mg enrofloxacin.
    (2) Each chewable tablet contains 22.7, 68.0, or 136.0 mg 
enrofloxacin.
    (3) Each soft chewable tablet contains 22.7, 68.0, or 136.0 mg 
enrofloxacin.
    (b) Sponsors. See sponsor numbers in Sec. 510.600(c) of this 
chapter for use as in paragraph (c) of this section.
    (1) No. 058198 for use of products described in paragraphs (a)(1)(i) 
and (a)(2) and (3) of this section.
    (2) No. 017033 for use of product described in paragraph (a)(1)(i) 
of this section.
    (3) No. 058198 for use of product described in paragraph (a)(1)(ii) 
of this section.
    (4) No. 086101 for use of product described in paragraph (a)(2) of 
this section.
    (c) Conditions of use in dogs and cats--(1) Amount. Administer 
orally as a single, daily dose or divided into two equal doses at 12-
hour intervals.
    (i) Dogs. 5 to 20 mg per kilogram (/kg) (2.27 to 9.07 mg per pound 
(/lb)) of body weight.
    (ii) Cats. 5 mg/kg (2.27 mg/lb) of body weight.
    (2) Indications for use. For the management of diseases associated 
with bacteria susceptible to enrofloxacin.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian. Federal law prohibits the extralabel 
use of this drug in food-producing animals.

[78 FR 30197, May 22, 2013, as amended at 78 FR 52853, Aug. 27, 2013; 84 
FR 8972, Mar. 13, 2019; 84 FR 53310, Oct. 7, 2019; 86 FR 13184, Mar. 8, 
2021; 86 FR 14818, Mar. 19, 2021]



Sec. 520.816  Epsiprantel.

    (a) Specifications. Each tablet contains either 12.5, 25, 50, or 100 
milligrams of epsiprantel.
    (b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use--(1) Dogs--(i) Amount. 2.5 milligrams per 
pound of body weight.
    (ii) Indications for use. Removal of canine cestodes Dipylidium 
caninum and Taenia pisiformis.
    (2) Cats--(i) Amount. 1.25 milligrams per pound of body weight.
    (ii) Indications for use. Removal of feline cestodes D. caninum and 
T. taeniaeformis.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[54 FR 50615, Dec. 8, 1989, as amended at 56 FR 50653, Oct. 8, 1991; 60 
FR 55659, Nov. 2, 1995; 79 FR 28821, May 20, 2014; 83 FR 64740, Dec. 18, 
2018]



Sec. 520.823  Erythromycin.

    (a) Specifications. Each gram of powder contains erythromycin 
phosphate equivalent to 0.89 gram of erythromycin master standard.
    (b) Sponsor. See No. 061133 in Sec. 510.600(c) of this chapter.
    (c) Related tolerances. See Sec. 556.230 of this chapter.
    (d) Conditions of use. It is used in drinking water as follows:
    (1) Broiler and replacement chickens--(i) Amount. Administer 0.500 
gram per gallon for 5 days.
    (ii) Indications for use. As an aid in the control of chronic 
respiratory disease due to Mycoplasma gallisepticum susceptible to 
erythromycin.
    (iii) Limitations. Do not use in replacement pullets over 16 weeks 
of age. Do not use in chickens producing eggs for human consumption. 
Withdraw 1 day before slaughter. Federal law restricts this drug to use 
by or on the order of a licensed veterinarian.
    (2) Replacement chickens and chicken breeders--(i) Amount. 
Administer 0.500 gram per gallon for 7 days.
    (ii) Indications for use. As an aid in the control of infectious 
coryza due to Haemophilus gallinarum susceptible to erythromycin.
    (iii) Limitations. Do not use in replacement pullets over 16 weeks 
of age. Do not use in chickens producing eggs for human consumption. 
Withdraw 1

[[Page 187]]

day before slaughter. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.
    (3) Growing turkeys--(i) Amount. Administer 0.500 gram per gallon 
for 7 days.
    (ii) Indications for use. As an aid in the control of blue comb 
(nonspecific infectious enteritis) caused by organisms susceptible to 
erythromycin.
    (iii) Limitations. Do not use in turkeys producing eggs for human 
consumption. Withdraw 1 day before slaughter. Federal law restricts this 
drug to use by or on the order of a licensed veterinarian.

[40 FR 13838, Mar. 27, 1975, as amended at 45 FR 56798, Aug. 26, 1980; 
66 FR 14073, Mar. 9, 2001; 68 FR 4914, Jan. 31, 2003; 79 FR 28821, May 
20, 2014; 81 FR 17607, Mar. 30, 2016; 81 FR 94989, Dec. 27, 2016; 84 FR 
8972, Mar. 13, 2019]



Sec. 520.852  Estriol.

    (a) Specifications. Each tablet contains 1 milligram (mg) estriol.
    (b) Sponsor. See No. 000061 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in dogs--(1) Amount. Administer at an initial 
dose of 2 mg per dog per day. The dosage may be titrated to as low as 
0.5 mg per dog every second day, depending on response.
    (2) Indications for use. For the control of estrogen-responsive 
urinary incontinence in ovariohysterectomized female dogs.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[76 FR 78150, Dec. 16, 2011]



Sec. 520.863  Ethylisobutrazine.

    (a) Specifications. Each tablet contains either 10 milligrams or 50 
milligrams of ethylisobutrazine hydrochloride.
    (b) Sponsor. See No. 000061 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in dogs--(1) Amount. Administer orally 2 to 5 
milligrams per pound of body weight once daily.
    (2) Indications for use. As a tranquilizer.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[40 FR 13838, Mar. 27, 1975, as amended at 46 FR 48642, Oct. 2, 1981; 61 
FR 8873, Mar. 6, 1996; 62 FR 61624, Nov. 19, 1997; 79 FR 28821, May 20, 
2014]



Sec. 520.870  Etodolac.

    (a) Specifications. Each tablet contains 150, 300, or 500 milligrams 
(mg) of etodolac.
    (b) Sponsor. See No. 000010 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in dogs--(1) Amount. Administer 10 to 15 mg 
per kilogram (4.5 to 6.8 mg per pound) of body weight per day orally.
    (2) Indications for use. For the management of pain and inflammation 
associated with osteoarthritis.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[63 FR 51300, Sept. 25, 1998, as amended at 68 FR 51705, Aug. 28, 2003; 
75 FR 10166, Mar. 5, 2010; 79 FR 28821, May 20, 2014]



Sec. 520.903  Febantel oral dosage forms.



Sec. 520.903a  Febantel paste.

    (a) Specifications. Each gram of paste contains 455 milligrams (45.5 
percent) febantel.
    (b) Sponsor. See No. 058198 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in horses--(1) Amount. Administer paste orally 
at 6 milligrams per kilogram (2.73 milligrams per pound) of body weight 
on the base of the tongue or well mixed into a portion of the normal 
grain ration. For animals maintained on premises where reinfection is 
likely to occur, retreatment may be necessary. For most effective 
results, retreat in 6 to 8 weeks.
    (2) Indications for use. For removal of large strongyles (Strongylus 
vulgaris, S. edentatus, S. equinus); ascarids (Parascaris equorum--
sexually mature and immature); pinworms (Oxyuris equi--adult and 4th 
stage larva); and various small strongyles in horses, foals, and ponies.
    (3) Limitations. Do not use in horses intended for human 
consumption. Consult your veterinarian for assistance in

[[Page 188]]

the diagnosis, treatment, and control of parasitism.

[79 FR 28821, May 20, 2014, as amended at 86 FR 14818, Mar. 19, 2021]



Sec. 520.903b  Febantel suspension.

    (a) Specifications. Each ounce of suspension contains 2.75 grams 
(9.3 percent ounce) febantel.
    (b) Sponsor. See No. 058198 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in horses--(1) Amount. 3 milliliters per 100 
pounds body weight or 1 fluid ounce per 1000 pounds (6 milligrams per 
kilogram body weight). Administer by stomach tube or drench, or by 
mixing well into a portion of the normal grain ration. For animals 
maintained on premises where reinfection is likely to occur, retreatment 
may be necessary. For most effective results, retreat in 6 to 8 weeks.
    (2) Indications for use. For removal of ascarids (Parascaris 
equorum--adult and sexually immature), pinworms (Oxyuris equi--adult and 
4th stage larvae), large strongyles (Strongylus vulgaris, S. edentatus, 
S. equinus), and various small strongyles in horses, breeding stallions 
and mares, pregnant mares, foals, and ponies.
    (3) Limitations. Do not use in horses intended for human 
consumption. Federal law restricts this drug to use by or on the order 
of a licensed veterinarian.
    (d) Special considerations. Febantel suspension may be used in 
combination with trichlorfon oral liquid in accordance with the 
provisions of Sec. 520.2520c, this section, and the following 
conditions:
    (1) Combine 1 part febantel suspension with 5 parts trichlorfon 
liquid.
    (2) Allow animal to consume a portion of daily grain ration; 
administer mixture by stomach tube at rate of 18 milliliters per 100 
pounds of body weight.

[45 FR 8587, Feb. 8, 1980, as amended at 79 FR 28821, May 20, 2014; 86 
FR 14818, Mar. 19, 2021]



Sec. 520.903c  Febantel and praziquantel paste.

    (a) Specifications. Each gram of paste contains 34 milligrams of 
febantel and 3.4 milligrams of praziquantel.
    (b) Sponsor. See No. 058198 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use--(1) Amount--(i) Dogs and cats (over 6 months 
of age): 10 milligrams of febantel and 1 milligram of praziquantel per 
kilogram of body weight (1 gram of paste per 7.5 pounds body weight) 
administered by mouth or in the food once daily for 3 days.
    (ii) Puppies and kittens (less than 6 months of age): 15 milligrams 
of febantel and 1.5 milligrams of praziquantel per kilogram of body 
weight (1 gram of paste per 5 pounds body weight) administered by mouth 
on a full stomach once daily for 3 days.
    (2) Indications for use. (i) Dogs and puppies: For removal of 
hookworms (Ancylostoma caninum and Uncinaria stenocephala), whipworms 
(Trichuris vulpis), ascarids (Toxocara canis and Toxascaris leonina), 
and tapeworms (Dipylidium caninum and Taenia pisiformis).
    (ii) Cats and kittens: For removal of hookworms (Ancylostoma 
tubaeforme), ascarids (Toxocara cati) and tapeworms (Dipylidium caninum 
and Taenia taeniaeformis).
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[50 FR 19167, May 7, 1985, as amended at 53 FR 48533, Dec. 1, 1988; 56 
FR 50813, Oct. 9, 1991; 79 FR 28821, May 20, 2014. Redesignated at 85 FR 
18119, Apr. 1, 2020; 86 FR 14818, Mar. 19, 2021]



Sec. 520.903d  Febantel tablets.

    (a) Specifications. Each scored tablet contains 27.2 milligrams of 
febantel for use in dogs, puppies, cats, and kittens or 163.3 milligrams 
of febantel for use in dogs, puppies, and cats.
    (b) Sponsor. See No. 058198 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use--(1) Amount--(i) Dogs and cats. Ten milligrams 
per kilogram body weight. Administer once daily for 3 consecutive days.
    (ii) Puppies and kittens fewer than 6 months of age. Fifteen 
milligrams per kilogram body weight. Administer once daily for 3 
consecutive days.
    (2) Indications for use. (i) For removal of hookworms (Ancylostoma 
caninum and Uncinaria stenocephala), ascarids (Toxocara canis and 
Toxascaris leonina) and whipworms (Trichuris vulpis) in dogs and 
puppies.

[[Page 189]]

    (ii) For removal of hookworms (Ancylostoma tubaeforme) and ascarids 
(Toxocara cati) in cats and kittens.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[56 FR 50655, Oct. 8, 1991, as amended at 79 FR 28821, May 20, 2014. 
Redesignated at 85 FR 18119, Apr. 1, 2020, as amended at 86 FR 14818, 
Mar. 19, 2021]



Sec. 520.905  Fenbendazole oral dosage forms.



Sec. 520.905a  Fenbendazole suspension.

    (a) Specifications. Each milliliter of suspension contains 100 
milligrams (mg) fenbendazole for use as in paragraphs (e)(1), (2), (3), 
and (4) of this section; or 200 mg fenbendazole for use as in paragraphs 
(e)(5) and (6) of this section.
    (b) Sponsor. See No. 000061 in Sec. 510.600(c) of this chapter.
    (c) Related tolerances. See Sec. 556.275 of this chapter.
    (d) Special considerations. (1) See Sec. 500.25 of this chapter.
    (2) Fenbendazole suspension 10 percent and approved forms of 
trichlorfon, when used concomitantly for treating the indications 
provided in paragraph (e) of this section and for treating infections of 
stomach bot as provided in Sec. 520.2520, have been shown to be 
compatible and not to interfere with one another.
    (e) Conditions of use--(1) Horses--(i) Amount. Administer orally 5 
mg per kilogram (/kg) (2.3 mg per pound (/lb)) for the control of large 
strongyles, small strongyles, and pinworms; 10 mg/kg for the control of 
ascarids.
    (ii) Indications for use. For the control of large strongyles 
(Strongylus edentatus, S. equinus, S. vulgaris), small strongyles 
(Cyanthostomum spp., Cylicocyclus spp., Cylicostephanus spp., 
Triodontophorus spp.), pinworms (Oxyuris equi), and ascarids (Parascaris 
equorum) in horses.
    (iii) Limitations. Administer by dose syringe or suitable plastic 
syringe. Do not use in horses intended for human consumption.
    (2) Cattle including dairy cows of breeding age--(i) Amount. 
Administer orally 5 mg/kg of body weight (2.3 mg/lb). Retreatment may be 
needed after 4 to 6 weeks.
    (ii) Indications for use. For the removal and control of lungworm 
(Dictyocaulus viviparus); stomach worm (adults)--brown stomach worm 
(Ostertagia ostertagi); stomach worms (adults and 4th-stage larvae)--
barberpole worm (Haemonchus contortus and H. placei) and small stomach 
worm (Trichostongylus axei); intestinal worms (adults and 4th-stage 
larvae)--hookworm (Bunostonmum phlebotomum), threadnecked intestinal 
worm (Nematodirus helvetianus), small intestinal worm (Cooperia punctata 
and C. oncophora), bankrupt worm (Trichostrongylus colubriformis), and 
nodular worm (Oesophagostomum radiatum).
    (iii) Limitations. Cattle must not be slaughtered within 8 days 
following last treatment. A withdrawal period has not been established 
for this product in preruminating calves. Do not use in calves to be 
processed for veal.
    (3) Beef cattle--(i) Amount. Administer orally 10 mg/kg of body 
weight (2.3 mg/lb). Retreatment may be needed after 4 to 6 weeks.
    (ii) Indications for use. For the removal and control of stomach 
worm (4th stage inhibited larvae/type II ostertagiasis), Ostertagia 
ostertagi, and tapeworm, Moniezia benedeni.
    (iii) Limitations. Cattle must not be slaughtered within 8 days 
following last treatment. A withdrawal period has not been established 
for this product in preruminating calves. Do not use in calves to be 
processed for veal. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.
    (4) Goats--(i) Amount. Administer orally 5 mg/kg of body weight (2.3 
mg/lb). Retreatment may be needed after 4 to 6 weeks.
    (ii) Indications for use. For the removal and control of stomach 
worms (adults) Haemonchus contortus and Teladorsagia circumcincta.
    (iii) Limitations. Goats must not be slaughtered for food within 6 
days following last treatment. Do not use in lactating goats.
    (5) Chickens--(i) Amount. Administer orally via drinking water at a 
daily

[[Page 190]]

dose of 1 mg/kg body weight (0.454 mg/lb) for 5 consecutive days.
    (ii) Indications for use. For the treatment and control of adult 
Ascaridia galli in broiler chickens and replacement chickens, and for 
the treatment and control of adult A. galli and Heterakis gallinarum in 
breeding chickens and laying hens.
    (6) Swine, except for nursing piglets--(i) Amount. Administer orally 
via the drinking water at a daily dose of 2.2 mg/kg of body weight (1.0 
mg/lb) for 3 consecutive days.
    (ii) Indications for use. For the treatment and control of: 
Lungworms: Adult Metastrongylus apri, Adult Metastrongylus 
pudendotectus; Gastrointestinal worms: Adult and larvae (L3, L4 stages, 
liver, lung, intestinal forms) large roundworms (Ascaris suum), Adult 
nodular worms (Oesophagostomum dentatum, O. quadrispinulatum), Adult 
small stomach worms (Hyostrongylus rubidus), Adult and larvae (L2, L3, 
L4 stages--intestinal mucosal forms) whipworms (Trichuris suis); and 
Kidney worms: Adult and larvae Stephanurus dentatus.
    (iii) Limitations. Swine intended for human consumption must not be 
slaughtered within 2 days from the last treatment.

[42 FR 59069, Nov. 15, 1977; 43 FR 12311, Mar. 24, 1978. Redesignated at 
44 FR 1375, Jan. 5, 1979, and amended at 46 FR 29464, June 2, 1981; 47 
FR 15327, Apr. 9, 1982; 48 FR 42809, Sept. 20, 1983; 49 FR 1983, Jan. 
17, 1984; 53 FR 40058, Oct. 13, 1988; 59 FR 26943, May 25, 1994; 61 FR 
29478, June 11, 1996; 63 FR 63983, Nov. 18, 1998; 66 FR 47960, Sept. 17, 
2001; 68 FR 26205, May 15, 2003; 74 FR 17770, Apr. 17, 2009; 74 FR 
61516, Nov. 25, 2009; 76 FR 17336, Mar. 29, 2011; 80 FR 76386, Dec. 9, 
2015; 81 FR 22523, Apr. 18, 2016; 86 FR 14818, Mar. 19, 2021]



Sec. 520.905b  Fenbendazole granules.

    (a) Specifications. Each gram of granules contains 222 milligrams 
(mg) fenbendazole.
    (b) Sponsor. See No. 000061 in Sec. 510.600(c) of this chapter.
    (c) Special considerations. See Sec. 500.25 of this chapter.
    (d) Conditions of use--(1) Horses--(i) Amount. 5 mg/kilogram (kg) 
for large strongyles, small strongyles, and pinworms; 10 mg/kg for 
ascarids.
    (ii) Indications for use. For the control of infections of large 
strongyles (Strongylus edentatus, S. equinus, S. vulgaris), small 
strongyles, pinworms (Oxyuris equi), and ascarids (Parascaris equorum).
    (iii) Limitations. Sprinkle the appropriate amount of drug on a 
small amount of the usual grain ration. Prepare for each horse 
individually. Withholding feed or water is not necessary. Retreat in 6 
to 8 weeks if required. Do not use in horses intended for food.
    (2) Dogs--(i) Amount. 50 mg/kg daily for 3 consecutive days.
    (ii) Indications for use. For the treatment and control of ascarids 
(Toxocara canis, Toxascaris leonina), hookworms (Ancylostoma caninum, 
Uncinaria stenocephala), whipworms (Trichuris vulpis), and tapeworms 
(Taenia pisiformis).
    (iii) Limitations. Mix the appropriate amount of drug with a small 
amount of the usual food; dry dog food may require slight moistening to 
facilitate mixing. Medicated food must be fully consumed.
    (3) Zoo and wildlife animals--(i) Amount. 10 mg/kg per day for 3 
days.
    (ii) Indications for use. For control of internal parasites of 
Felidae and Ursidae as follows:
    (A) Lion (Panthera leo) and Tiger (Panthera tigris): Ascarid 
(Toxocara cati, Toxascaris leonina), Hookworm (Ancylostoma spp.).
    (B) Cheetah (Acinonyx jubatus): Ascarid (Toxocara cati, Toxascaris 
leonina).
    (C) Puma (Felis concolor), Panther (Panthera spp.), Leopard 
(Panthera pardus), Jaguar (Panthera onca): Ascarid (Toxocara cati, 
Toxascaris leonina), Hookworm (Ancylostoma spp.), Tapeworm (Taenia 
hydatigena, T. krabbei, T. taeniaeformis).
    (D) Black Bear (Ursus americanus): Ascarid (Baylisascaris transfuga, 
Toxascaris leonina), Hookworm (Ancylostoma caninum), Tapeworm (Taenia 
hydatigena, T. krabbei).
    (E) Polar Bear (Ursus maritimus) and Grizzly Bear (Ursus 
horribilis): Ascarid (Baylisascaris transfuga, Toxascaris leonina).
    (iii) Limitations. Top dress or mix with a small portion of food. 
Must be fully consumed prior to feeding. Federal law restricts this drug 
to use by or on the order of a licensed veterinarian.

[[Page 191]]

Do not use 14 days before or during the hunting season.

[44 FR 1375, Jan. 5, 1979, as amended at 47 FR 15327, Apr. 9, 1982; 48 
FR 50528, Nov. 2, 1983; 59 FR 35252, July 11, 1994; 66 FR 47960, Sept. 
17, 2001; 67 FR 47450, July 19, 2002; 71 FR 19429, Apr. 14, 2006; 74 FR 
61516, Nov. 25, 2009]



Sec. 520.905c  Fenbendazole paste.

    (a) Specifications. Each gram of paste contains 100 milligrams (mg) 
fenbendazole (10 percent).
    (b) Sponsor. See No. 000061 in Sec. 510.600(c) of this chapter.
    (c) Related tolerances. See Sec. 556.275 of this chapter.
    (d) Special considerations. See Sec. 500.25 of this chapter.
    (e) Conditions of use--(1) Horses--(i) Indications for use and 
amounts. (A) For control of large strongyles (Strongylus edentatus, S. 
equinus, S. vulgaris), small strongyles, pinworms (Oxyuris equi), and 
ascarids (Parascaris equorum): 2.3 mg per pound (/lb) of body weight, or 
for foals and weanlings (less than 18 months of age), 4.6 mg/lb of body 
weight. Retreatment at intervals of 6 to 8 weeks may be required.
    (B) For control of arteritis caused by the fourth-stage larvae of S. 
vulgaris: 4.6 mg/lb of body weight daily for 5 days. Treatment should be 
initiated in the spring and repeated in 6 months.
    (C) For treatment of encysted mucosal cyathostome (small strongyle) 
larvae including early third-stage (hypobiotic), late third-stage, and 
fourth-stage larvae: 4.6 mg/lb of body weight daily for 5 consecutive 
days.
    (D) Fenbendazole paste 10 percent may be used concomitantly with 
approved forms of trichlorfon for the indications provided in paragraph 
(e)(1)(i)(A) of this section and for treating infections of stomach bots 
as provided in Sec. 520.2520.
    (ii) Limitations. Do not use in horses intended for human 
consumption.
    (2) Cattle--(i) Amount. 2.3 mg/lb of body weight. Retreatment may be 
needed after 4 to 6 weeks.
    (ii) Indications for use. For the removal and control of lungworms 
(Dictyocaulus viviparus), stomach worms (Haemonchus contortus, 
Ostertagia ostertagi, Trichostrongylus axei), and intestinal worms 
(Bunostomum phlebotomum, Nematodirus helvetianus, Cooperia punctata, C. 
oncophora, Trichostrongylus colubriformis, and Oesophagostomum 
radiatum).
    (iii) Limitations. Cattle must not be slaughtered within 8 days 
following last treatment. A withdrawal period has not been established 
for this product in preruminating calves. Do not use in calves to be 
processed for veal.

[72 FR 24185, May 2, 2007, as amended at 74 FR 61516, Nov. 25, 2009; 76 
FR 17337, Mar. 29, 2011]



Sec. 520.905d  Fenbendazole powder.

    (a) Specifications. Each 2-ounce packet contains 2.27 grams (4 
percent) fenbendazole.
    (b) Sponsor. See No. 000061 in Sec. 510.600(c) of this chapter.
    (c) Related tolerances. See Sec. 556.275 of this chapter.
    (d) Conditions of use. It is administered to swine as follows:
    (1) Amount. 3 milligrams fenbendazole per kilogram body weight per 
day (1.36 milligrams per pound per day).
    (2) Indications for use. For removal and control of large roundworms 
(Ascaris suum); lungworms (Metastrongylus apri); nodular worms 
(Oesophagostomum dentatum, O. quadrispinulatum); small stomach worms 
(Hyostrongylus rubidus); whipworms (Trichuris suis); and kidneyworms 
(Stephanurus dentatus-- mature and immature).
    (3) Limitations. Thoroughly mix the contents of the packet(s) with 
swine ration and administer according to label directions. Feed as sole 
ration for 3 consecutive days. Can be fed to pregnant sows. No prior 
withdrawal of feed or water is necessary. Consult your veterinarian for 
assistance in the diagnosis, treatment, and control of parasitism.

[49 FR 18090, Apr. 27, 1984, as amended at 49 FR 20485, May 15, 1984; 66 
FR 47960, Sept. 17, 2001; 70 FR 32489, June 3, 2005; 74 FR 61516, Nov. 
25, 2009; 83 FR 48945, Oct. 9, 2018]



Sec. 520.905e  Fenbendazole blocks.

    (a) Specifications. (1) Each pound of molasses block contains 750 
milligrams of fenbendazole.
    (2) Each pound of protein block contains 750 milligrams of 
fenbendazole.

[[Page 192]]

    (b) Sponsor. See 000061 in Sec. 510.600(c) of this chapter.
    (c) Related tolerances. See Sec. 556.275 of this chapter.
    (d) Conditions of use--(1) Amount. 0.1 pound of block per 100 pounds 
of body weight per day for 3 days. Total dose for the 3-day period is 
2.27 milligrams of fenbendazole per pound of body weight for mature 
cattle.
    (2) Indications for use. For removal and control of infections of 
lungworms (Dictyocaulus viviparus) and gastrointestinal roundworms 
(Haemonchus contortus, Ostertagia ostertagi, Trichostrongylus axei, 
Bunostomum phlebotomum, Nematodirus helvetianus, Cooperia oncophora and 
C. punctata, Trichostrongylus colubriformis, and Oesophagostomum 
radiatum) in beef cattle.
    (3) Limitations. Administer free choice of beef cattle on pasture 
that have become accustomed to nonmedicated block feeding during an 
adaptation period of 12 to 19 days. Molasses block: Cattle must not be 
slaughtered within 11 days following last treatment. Protein block: 
Cattle must not be slaughtered within 16 days following last treatment; 
do not use in dairy cattle of breeding age. Animals maintained under 
conditions of constant worm exposure may require retreatment within 6 to 
8 weeks. Consult your veterinarian for assistance in the diagnosis, 
treatment, and control of parasitism.

[51 FR 41783, Nov. 19, 1986, as amended at 54 FR 20787, May 15, 1989; 66 
FR 47960, Sept. 17, 2001; 74 FR 61516, Nov. 25, 2009]



Sec. 520.928  Firocoxib tablets.

    (a) Specifications. Each chewable tablet contains 57 or 227 
milligrams (mg) firocoxib.
    (b) Sponsor. See No. 000010 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use--(1) Dogs--(i) Amount. 5 mg/kg (2.27 mg/lb) 
body weight. Administer once daily for osteoarthritis. Administer 
approximately 2 hours before soft tissue or orthopedic surgery.
    (ii) Indications for use. For the control of pain and inflammation 
associated with osteoarthritis; and for the control of postoperative 
pain and inflammation associated with soft-tissue and orthopedic 
surgery.
    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.
    (2) Horses--(i) Amount. Administer one 57-mg tablet to horses 
weighing 800 to 1,300 lb once daily for up to 14 days.
    (ii) Indications for use. For the control of pain and inflammation 
associated with osteoarthritis.
    (iii) Limitations. Do not use in horses intended for human 
consumption. Federal law restricts this drug to use by or on the order 
of a licensed veterinarian.

[69 FR 51171, Aug. 18, 2004, as amended at 73 FR 2808, Jan. 16, 2008; 73 
FR 64885, Oct. 31, 2008; 81 FR 67151, Sept. 30, 2016; 84 FR 39183, Aug. 
9, 2019]



Sec. 520.930  Firocoxib paste.

    (a) Specifications. Each milligram (mg) of paste contains 0.82 mg 
firocoxib.
    (b) Sponsors. See No. 000010 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in horses--(1) Amount. 0.1 mg per kilogram 
(0.045 mg per pound) body weight daily for up to 14 days.
    (2) Indications for use. For the control of pain and inflammation 
associated with osteoarthritis.
    (3) Limitations. Do not use in horses intended for human 
consumption. Federal law restricts this drug to use by or on the order 
of a licensed veterinarian.

[71 FR 5788, Feb. 3, 2006, as amended at 84 FR 39183, Aug. 9, 2019]



Sec. 520.955  Florfenicol.

    (a) Specifications. Each milliliter (mL) contains 23 milligrams (mg) 
florfenicol.
    (b) Sponsors. See Nos. 000061, 054925, and 058198 in Sec. 
510.600(c) of this chapter.
    (c) Related tolerances. See Sec. 556.283 of this chapter.
    (d) Conditions of use in swine--(1) Amount. Administer in drinking 
water ad libitum at 400 mg per gallon (100 parts per million (ppm)) for 
5 consecutive days.
    (2) Indications for use. For the treatment of swine respiratory 
disease (SRD) associated with Actinobacillus pleuropneumoniae, 
Pasteurella multocida, Salmonella choleraesuis and Streptococcus suis.
    (3) Limitations. Do not slaughter within 16 days of last treatment. 
Federal

[[Page 193]]

law restricts this drug to use by or on the order of a licensed 
veterinarian.

[67 FR 78357, Dec. 24, 2002, as amended at 72 FR 262, Jan. 4, 2007; 78 
FR 52854, Aug. 27, 2013; 82 FR 12169, Mar. 1, 2017]



Sec. 520.960  Flumethasone.

    (a) Specifications. Each tablet contains 0.0625 milligram of 
flumethasone.
    (b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use--(1) Amount--(i) Dogs: Administer orally from 
0.0625 to 0.25 milligram daily in divided doses.
    (ii) Cats: Administer orally from 0.03125 to 0.125 milligram daily 
in divided doses.
    (2) Indications for use--(i) Dogs: It is used for musculoskeletal 
conditions due to inflammation of muscles or joints and accessory 
structures, where permanent structural changes do not exist, such as 
arthritis, the disc syndrome, and myositis.
    (ii) Dogs and cats: It is used in certain acute and chronic 
dermatoses of varying etiology to help control the pruritus, irritation, 
and inflammation associated with these conditions.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[44 FR 7131, Feb. 6, 1979, as amended at 61 FR 5506, Feb. 13, 1996; 79 
FR 28821, May 20, 2014]



Sec. 520.970  Flunixin.

    (a) Specifications. (1) Each 10-gram (g) packet of granules contains 
flunixin meglumine equivalent to 250 milligrams (mg) of flunixin.
    (2) Each 30-g syringe of paste contains flunixin meglumine 
equivalent to 1,500 mg of flunixin.
    (b) Sponsors. See sponsors in Sec. 510.600(c) of this chapter for 
use as in paragraph (c) of this section.
    (1) No. 000061 for use of products described in paragraph (a).
    (2) No. 061133 for use of the product described in paragraph (a)(2).
    (c) Conditions of use in horses--(1) Amount. 0.5 mg per pound of 
body weight per day for up to 5 days.
    (2) Indications for use. For alleviation of inflammation and pain 
associated with musculoskeletal disorders.
    (3) Limitations. Do not use in horses intended for human 
consumption. Federal law restricts this drug to use by or on the order 
of a licensed veterinarian.

[76 FR 53051, Aug. 25, 2011, as amended at 79 FR 74020, Dec. 15, 2014; 
84 FR 8972, Mar. 13, 2019]



Sec. 520.980  Fluoxetine.

    (a) Specifications. Each chewable tablet contains 8, 16, 32, or 64 
milligrams (mg) fluoxetine hydrochloride.
    (b) Sponsor. See No. 055246 in Sec. 510.600 of this chapter.
    (c) Conditions of use in dogs--(1) Amount. 1 to 2 mg per kilogram 
body weight once daily.
    (2) Indications for use. For the treatment of canine separation 
anxiety in conjunction with a behavior modification plan.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[72 FR 6463, Feb. 12, 2007, as amended at 79 FR 74020, Dec. 15, 2014; 82 
FR 21690, May 10, 2017]



Sec. 520.998  Fluralaner.

    (a) Specifications. (1) Each chewable tablet contains 112.5, 250, 
500, 1,000, or 1,400 milligrams (mg) fluralaner.
    (2) Each chewable tablet contains 45, 100, 200, 400, or 560 mg 
fluralaner.
    (b) Sponsor. See No. 000061 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in dogs--(1) Amount. Administer orally as a 
single dose with food:
    (i) Chewable tablets described in paragraph (a)(1) of this section. 
Administer every 12 weeks, an appropriate combination of tablets to 
provide a minimum dose of 11.4 mg per pound (lb) (25 mg per kilogram 
(kg)) body weight. May be administered every 8 weeks in case of 
potential exposure to Amblyomma americanum ticks.
    (ii) Chewable tablets described in paragraph (a)(2) of this section. 
Administer monthly, an appropriate combination of tablets to provide a 
minimum dose of 4.5 mg/lb (10 mg/kg) body weight.
    (2) Indications for use--(i) Chewable tablets described in paragraph 
(a)(1) of this section. Kills adult fleas; for the treatment and 
prevention of flea infestations (Ctenocephalides felis), and the 
treatment and control of tick infestations [Ixodes scapularis (black-
legged tick), Dermacentor variabilis (American

[[Page 194]]

dog tick), and Rhipicephalus sanguineus (brown dog tick)] for 12 weeks 
in dogs and puppies 6 months of age and older, and weighing 4.4 lbs or 
greater; and for the treatment and control of Amblyomma americanum (lone 
star tick) infestations for 8 weeks in dogs and puppies 6 months of age 
and older, and weighing 4.4 lbs or greater.
    (ii) Chewable tablets described in paragraph (a)(2) of this section. 
Kills adult fleas; for the treatment and prevention of flea infestations 
(C. felis), and the treatment and control of tick infestations [I. 
scapularis (black-legged tick), D. variabilis (American dog tick), and 
R. sanguineus (brown dog tick)] for 1 month in dogs and puppies 8 weeks 
of age and older, and weighing 4.4 lbs or greater; and for the treatment 
and control of A. americanum (lone star tick) infestations for 1 month 
in dogs and puppies 6 months of age and older, and weighing 4.4 lbs or 
greater.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[86 FR 14818, Mar. 19, 2021]



Sec. 520.1010  Furosemide.

    (a) Specifications. (1) Each tablet contains 12.5 or 50 milligrams 
(mg) furosemide.
    (2) Each bolus contains 2 grams (g) furosemide.
    (3) Each packet of powder contains 2 g furosemide.
    (4) Each milliliter of syrup contains 10 mg furosemide.
    (b) Sponsors. See sponsor numbers in Sec. 510.600(c) of this 
chapter for use of dosage forms and strengths listed in paragraph (a) of 
this section for uses as in paragraph (d) of this section.
    (1) No. 000010 for tablets in paragraph (a)(1) of this section for 
conditions of use in paragraphs (d)(2)(i), (d)(2)(ii)(A), and (d)(3) of 
this section.
    (2) No. 000061 for tablets in paragraph (a)(1) of this section for 
conditions of use in paragraphs (d)(2)(i), (d)(2)(ii)(A), and (d)(3) of 
this section; for boluses in paragraph (a)(2) of this section and powder 
in paragraph (a)(3) of this section for conditions of use in paragraph 
(d)(1) of this section; and for syrup in paragraph (a)(4) of this 
section for conditions of use in paragraphs (d)(2)(i) and (d)(2)(ii)(A).
    (3) Nos. 058829 and 069043 for use of syrup in paragraph (a)(4) of 
this section for conditions of use in paragraph (d)(2)(i) and 
(d)(2)(ii)(A) of this section.
    (c) Special considerations. Federal law restricts this drug to use 
by or on the order of a licensed veterinarian.
    (d) Conditions of use. It is used as follows:
    (1) Cattle--(i) Amount. 1 to 2 mg per pound (/lb) body weight using 
powder, or one 2-g bolus per animal, per day.
    (ii) Indications for use. For treatment of physiological parturient 
edema of the mammary gland and associated structures.
    (iii) Limitations. Treatment not to exceed 48 hours post-
parturition. Milk taken during treatment and for 48 hours after the last 
treatment must not be used for food. Cattle must not be slaughtered for 
food within 48 hours following last treatment.
    (2) Dogs--(i) Amount. 1 to 2 mg/lb body weight, once or twice daily.
    (ii) Indications for use. (A) For treatment of edema (pulmonary 
congestion, ascites) associated with cardiac insufficiency and acute 
noninflammatory tissue edema.
    (B) For treatment of edema (pulmonary congestion, ascites) 
associated with cardiac insufficiency.
    (3) Cats--(i) Amount. 1 to 2 mg/lb body weight, once or twice daily.
    (ii) Indications for use. For treatment of edema (pulmonary 
congestion, ascites) associated with cardiac insufficiency and acute 
noninflammatory tissue edema.

[66 FR 47960, Sept. 17, 2001, as amended at 69 FR 74419, Dec. 14, 2004; 
70 FR 50182, Aug. 26, 2005; 70 FR 76396, Dec. 27, 2005; 74 FR 61516, 
Nov. 25, 2009; 78 FR 17596, Mar. 22, 2013; 81 FR 17607, Mar. 30, 2016]



Sec. 520.1044  Gentamicin sulfate oral dosage forms.



Sec. 520.1044a  Gentamicin sulfate oral solution.

    (a) Specifications. Each milliliter of aqueous solution contains 
gentamicin sulfate equivalent to 50 milligrams of gentamicin.
    (b) Sponsor. See Nos. 000061 and 054925 in Sec. 510.600(c) of this 
chapter.
    (c) Related tolerances. See Sec. 556.300 of this chapter.

[[Page 195]]

    (d) Conditions of use--(1) Amount. Colibacillosis: 1 milliliter per 
2 gallons of drinking water for 3 consecutive days, to provide 0.5 
milligram/pound/day; swine dysentery: 1 milliliter per 1 gallon of 
drinking water for 3 consecutive days, to provide 1.0 milligram/pound/
day.
    (2) Indications for use. In weanling swine for control and treatment 
of colibacillosis caused by strains of E. coli sensitive to gentamicin, 
and in swine for control and treatment of swine dysentery associated 
with Treponema hyodysenteriae.
    (3) Limitations. Do not slaughter treated swine for food for at 
least 3 days following treatment. Federal law restricts this drug to use 
by or on the order of a licensed veterinarian.

[48 FR 10302, Mar. 11, 1983. Redesignated at 49 FR 572, Jan. 5, 1984, 
and amended at 49 FR 14332, Apr. 11, 1984; 52 FR 7832, Mar. 13, 1987; 62 
FR 34169, June 25, 1997; 71 FR 13542, Mar. 16, 2006; 81 FR 94989, Dec. 
27, 2016]



Sec. 520.1044b  Gentamicin sulfate pig pump oral solution.

    (a) Specifications. Each milliliter of pig pump oral solution 
contains gentamicin sulfate equivalent to 4.35 milligrams of gentamicin.
    (b) Sponsor. See Nos. 000061 and 016592 in Sec. 510.600(c) of this 
chapter.
    (c) Related tolerances. See Sec. 556.300 of this chapter.
    (d) Conditions of use--(1) Amount. Administer 1.15 milliliters of 
pig pump oral solution (5 milligrams of gentamicin) orally per pig one 
time.
    (2) Indications for use. In neonatal swine 1 to 3 days of age for 
control and treatment of colibacillosis caused by strains of E. coli 
sensitive to gentamicin.
    (3) Limitations. For use in neonatal swine only. Do not slaughter 
treated swine for food for at least 14 days following treatment.

[49 FR 572, Jan. 5, 1984, as amended at 52 FR 7832, Mar. 13, 1987; 62 FR 
29011, May 29, 1997; 78 FR 17596, Mar. 22, 2013; 81 FR 22523, Apr. 18, 
2016]



Sec. 520.1044c  Gentamicin sulfate powder.

    (a) Specifications. Each gram of powder contains gentamicin sulfate 
equivalent to:
    (1) 16.7, 66.7, or 333.3 milligrams (mg) gentamicin.
    (2) 333.3 mg gentamicin.
    (b) Sponsors. See sponsors in Sec. 510.600(c) of this chapter for 
use as in paragraph (d) of this section as follows:
    (1) No. 000061 for products described in paragraph (a)(1) of this 
section.
    (2) Nos. 016592 and 061133 for product described in paragraph (a)(2) 
of this section.
    (c) Related tolerances. See Sec. 556.300 of this chapter.
    (d) Conditions of use in swine--(1) Amount. Administer in drinking 
water for 3 consecutive days as follows:
    (i) For colibacillosis: Gentamicin sulfate equivalent to 25 mg of 
gentamicin per gallon of drinking water to provide 0.5 mg per pound of 
body weight per day;
    (ii) For swine dysentery: Gentamicin sulfate equivalent to 50 mg of 
gentamicin per gallon of drinking water to provide 1 mg per pound of 
body weight per day. Treatment may be repeated if dysentery recurs.
    (2) Indications for use. For control and treatment of colibacillosis 
in weanling swine caused by strains of Escherichia coli sensitive to 
gentamicin, and for control and treatment of swine dysentery associated 
with Treponema hyodysenteriae.
    (3) Limitations. Withdrawal period: 10 days. Federal law restricts 
this drug to use by or on the order of a licensed veterinarian.

[77 FR 4226, Jan. 27, 2012, as amended at 81 FR 94989, Dec. 27, 2016; 83 
FR 48945, Sept. 28, 2018; 84 FR 8972, Mar. 13, 2019]



Sec. 520.1060  Glucose and glycine.

    (a) Specifications. Each packet of powder contains 8.82 grams sodium 
chloride, 4.20 grams potassium phosphate, 0.5 gram citric acid 
anhydrous, 0.12 gram potassium citrate, 6.36 grams aminoacetic acid 
(glycine), and 44.0 grams glucose.
    (b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in calves--(1) Amount. Dissolve each packet in 
2 quarts of warm water and administer to each calf as follows:
    (i) Scouring and/or dehydrated calves. Feed 2 quarts of solution, 
twice daily for 2 days (four feedings). No milk or

[[Page 196]]

milk replacer should be fed during this period. For the next four 
feedings (days 3 and 4), use 1 quart of solution together with 1 quart 
of milk replacer. Thereafter, feed as normal.
    (ii) Newly purchased calves. Feed 2 quarts of solution instead of 
milk as the first feed upon arrival. For the next scheduled feeding, use 
1 quart of solution mixed together with 1 quart of milk or milk 
replacer. Thereafter, feed as normal.
    (2) Indications for use. For control of dehydration associated with 
diarrhea (scours); and as an early treatment at the first signs of 
scouring. It may also be used as followup treatment following 
intravenous fluid therapy.
    (3) Limitations. The product should not be used in animals with 
severe dehydration (down, comatose, or in a state of shock). Such 
animals need intravenous therapy. A veterinarian should be consulted in 
severely scouring calves. The product is not nutritionally complete if 
administered by itself for long periods of time. It should not be 
administered beyond the recommended treatment period without the 
addition of milk or milk replacer.

[79 FR 28821, May 20, 2014]



Sec. 520.1084  Grapiprant.

    (a) Specifications. Each tablet contains 20, 60, or 100 milligrams 
(mg) grapiprant.
    (b) Sponsor. See No. 058198 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in dogs--(1) Amount. Administer 0.9 mg/lb (2 
mg/kg) once daily by mouth.
    (2) Indications for use. For the control of pain and inflammation 
associated with osteoarthritis in dogs.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[81 FR 36789, June 8, 2016, as amended at 83 FR 14587, Apr. 5, 2018]



Sec. 520.1100  Griseofulvin.

    (a) Specifications. (1) The powder complies with U.S.P. for 
griseofulvin, microsize.
    (2) Each bolus contains 2.5 grams griseofulvin.
    (3) Each tablet contains 125 or 500 milligrams griseofulvin.
    (b) Sponsors. See sponsors in Sec. 510.600(c) of this chapter.
    (1) No. 000061 for use of products described in paragraph (a) for 
use as in paragraph (d) of this section.
    (2) No. 061133 for use of the powder described in paragraph (a)(1) 
for use as in paragraphs (d)(1)(i)(A) and (d)(1)(ii) of this section.
    (c) Special considerations. Federal law restricts this drug to use 
by or on the order of a licensed veterinarian.
    (d) Conditions of use--(1) Horses--(i) Amount and indications for 
use. (A) For equine ringworm infection caused by Trichophyton equinum or 
Microsporum gypseum, administer soluble powder described in paragraph 
(a)(1) of this section daily as a drench or as a top dressing on feed 
for not less than 10 days as follows: adults, 2.5 grams; yearlings, 1.25 
to 2.5 grams; and foals, 1.25 grams.
    (B) For treating ringworm infection caused by T. equinum, administer 
boluses described in paragraph (a)(2) of this section daily for not less 
than 10 days as follows: adults, 1 bolus; yearlings, one-half to 1 
bolus; and foals, one-half bolus.
    (ii) Limitations. Do not use in horses intended for human 
consumption.
    (2) Dogs and cats: (i) Amount. 125- and 500-milligram tablets 
administered orally as follows:
    (A) Daily (single or divided) dose as follows: For animals weighing 
up to 6 pounds: 62.5 milligrams; for animals weighing 6 to 18 pounds: 
125 milligrams; for animals weighing 18 to 36 pounds: 250 milligrams; 
for animals weighing 36 to 48 pounds: 375 milligrams; for animal 
weighing 48 to 75 pounds: 500 milligrams.
    (B) Weekly (single) dose: If experience indicates that treatment is 
more effective for the drug given in large doses, administer at 
intervals of 7 to 10 days, a dose equal to 10 milligrams/pound of body 
weight x body weight x number of days between treatments. Dosage should 
be adjusted according to response. Administer additional dose after the 
animal is free of infection.
    (ii) Indications for use. For treatment of fungal infections of the 
skin, hair, and claws caused by Trichophyton mentagrophytes, T. rubrum, 
T. schoenleini, T. sulphurem, T. verrucosum, T. interdigitale, 
Epidermophyton

[[Page 197]]

floccosum, Microsporum gypseum, M. canis, M. audouini.

[40 FR 13838, Mar. 27, 1975, as amended at 41 FR 42948, Sept. 29, 1976; 
43 FR 28458, June 30, 1978; 52 FR 7832, Mar. 13, 1987; 54 FR 30205, July 
19, 1989; 71 FR 38073, July 5, 2006; 77 FR 28253, May 14, 2012; 78 FR 
28822, May 20, 2014; 84 FR 8972, Mar. 13, 2019]



Sec. 520.1120  Haloxon oral dosage forms.



Sec. 520.1120a  Haloxon drench.

    (a) Specifications. Each packet contains 141.5 grams haloxon.
    (b) Sponsor. See No. 000061 in Sec. 510.600(c) of this chapter.
    (c) Special considerations. Do not use any drug, insecticide, 
pesticide, or other chemical having cholinesterase-inhibiting activity 
either simultaneously or within a few days before or after treatment 
with haloxon.
    (d) Related tolerances. See Sec. 556.310 of this chapter.
    (e) Conditions of use in cattle--(1) Amount. Dissolve each packet in 
32 fluid ounces of water and administer as follows: For animals weighing 
up to 100 pounds: \1/2\ fluid ounce; for animals weighing 100 to 150 
pounds: \3/4\ fluid ounce; for animals weighing 150 to 200 pounds: 1 
fluid ounce; for animals weighing 200 to 300 pounds: 1\ 1/2\ fluid 
ounces; for animals weighing 300 to 450 pounds: 2 fluid ounces; for 
animals weighing 450 to 700 pounds: 3 fluid ounces; for animals weighing 
700 to 1,000 pounds: 4 fluid ounces; for animals weighing 1,000 to 1,200 
pounds: 5 fluid ounces; for animals weighing over 1,200 pounds: 6 fluid 
ounces. Retreat in 3 to 4 weeks.
    (2) Indications for use. For control of gastrointestinal roundworms 
of the genera Haemonchus, Ostertagia, Trichostrongylus, and Cooperia.
    (3) Limitations. Do not treat dairy animals of breeding age. Do not 
treat within 1 week of slaughter.

[40 FR 13838, Mar. 27, 1975, as amended at 45 FR 10333, Feb. 15, 1980; 
46 FR 48642, Oct. 2, 1981; 61 FR 8873, Mar. 6, 1996; 62 FR 61624, Nov. 
19, 1997; 78 FR 28822, May 20, 2014]



Sec. 520.1120b  Haloxon boluses.

    (a) Specifications. Each bolus contains 10.1 grams of haloxon.
    (b) Sponsor. See No. 000061 in Sec. 510.600(c) of this chapter.
    (c) Related tolerances. See Sec. 556.310 of this chapter.
    (d) Conditions of use in cattle--(1) Amount. Administered one bolus 
per 500 pounds body weight (35 to 50 milligrams per kilogram of body 
weight). Retreat in 3 to 4 weeks.
    (2) Indications for use. For control of gastrointestinal roundworms 
of the genera Haemonchus, Ostertagia, Trichostrongylus, and Cooperia.
    (3) Limitations. Do not treat dairy animals of breeding age or 
older. Do not treat within 1 week of slaughter.

[40 FR 13838, Mar. 27, 1975, as amended at 44 FR 61591, Oct. 29, 1979; 
46 FR 48642, Oct. 2, 1981; 61 FR 8873, Mar. 6, 1996; 62 FR 61625, Nov. 
19, 1997; 78 FR 28822, May 20, 2014]



Sec. 520.1130  Hetacillin.

    (a) Specifications. (1) Each capsule or tablet contains hetacillin 
potassium equivalent to 50, 100, or 200 milligrams (mg) of ampicillin.
    (2) Each milliliter of suspension contains hetacillin potassium 
equivalent to 50 mg of ampicillin.
    (b) Sponsor. See No. 000010 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in dogs and cats--(1) Amount--(i) Dogs. 
Administer 5 mg per pound (/lb) of body weight orally, twice daily. In 
severe infections, administer 5 mg/lb three times daily, or up to 10 mg/
lb twice daily. For stubborn urinary tract infections, administer up to 
20 mg/lb twice daily.
    (ii) Cats. Administer 50 mg twice daily.
    (2) Indications for use. For the treatment of respiratory tract 
infections, urinary tract infections, gastrointestinal infections, skin 
infections, soft tissue infections, and postsurgical infections 
associated with strains of organisms susceptible to hetacillin 
potassium.
    (3) Limitations. Federal law restricts this drug to use only by or 
on the order of a licensed veterinarian.

[75 FR 10166, Mar. 5, 2010]



Sec. 520.1150  Imepitoin.

    (a) Specifications. Each tablet contains 100 or 400 milligrams (mg) 
imepitoin.
    (b) Sponsor. See No. 000010 in Sec. 510.600(c) of this chapter.

[[Page 198]]

    (c) Conditions of use--(1) Amount. Administer orally twice daily, 
approximately 12 hours apart, at a dose of 13.6 mg per pound (30 mg/kg) 
of body weight. Initiate therapy starting 2 days prior to the day of the 
expected noise event and continuing through the noise event.
    (2) Indications for use. For the treatment of noise aversion in 
dogs.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[84 FR 12494, Apr. 2, 2019]



Sec. 520.1156  Imidacloprid.

    (a) Specifications. Each chewable tablet contains 7.5 or 37.5 
milligrams (mg) imidacloprid.
    (b) Sponsor. See No. 058198 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in dogs--(1) Amount. Administer daily one 7.5-
mg chewable tablet to dogs weighing 4 to 22 pounds (lb) or one 37.5-mg 
chewable table to dogs weighing 23 to 110 lb.
    (2) Indications for use. Kills adult fleas and is indicated for the 
treatment of flea infestations on dogs and puppies 10 weeks of age and 
older and weighing 4 lb or greater.
    (3) Limitations. Do not give to puppies younger than 10 weeks of age 
or to dogs weighing less than 4 lb. Do not give more than one tablet a 
day.

[80 FR 18775, Apr. 8, 2015, as amended at 86 FR 14818, Mar. 19, 2021]



Sec. 520.1157  Iodinated casein.

    (a) Specifications. Each 1-gram tablet contains 25 milligrams of 
iodinated casein.
    (b) Sponsor. See No. 017762 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use--(1) Amount. \1/5\ to 1 tablet per 10 pounds 
of body weight (equivalent to 0.5 to 2.5 milligrams of iodinated casein 
per pound of body weight).
    (2) Indications for use. For dogs for apparent decreased thyroid 
activity where the signs are alopecia, scaliness of the skin surface, 
loss of hair, seborrhea, thickening of the skin, hyperpigmentation, and 
lethargy.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[49 FR 22469, May 30, 1984, as amended at 78 FR 28822, May 20, 2014]



Sec. 520.1158  Iodochlorhydroxyquin.

    (a) Specifications. Each bolus contains 10 grams of 
iodochlorhydroxyquin.
    (b) Sponsor. See No. 054771 in Sec. 510.600 (c) of this chapter.
    (c) Conditions of use--(1) Amount. 1 bolus (10 grams) daily for a 
1,000-pound horse.
    (2) Indications for use. For treatment of equine diarrhea.
    (3) Limitations. Do not use in horses intended for human 
consumption. Federal law restricts this drug to use by or on the order 
of a licensed veterinarian.

[48 FR 8054, Feb. 25, 1983, as amended at 50 FR 41489, Oct. 11, 1985; 78 
FR 28822, May 20, 2014]



Sec. 520.1189  Itraconazole.

    (a) Specifications. Each milliliter (mL) of solution contains 10 
milligrams (mg) of itraconazole.
    (b) Sponsor. See No. 058198 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use--(1) Amount. Administer 5 mg/kilogram (kg) 
(0.5 mL/kg) of body weight once daily on alternating weeks for 3 
treatment cycles.
    (2) Indications for use. For the treatment of dermatophytosis caused 
by Microsporum canis in cats.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[82 FR 12169, Mar. 1, 2017]



Sec. 520.1192  Ivermectin paste.

    (a) Specifications. Each milligram (mg) of paste contains 0.0187 mg 
(1.87 percent) or 0.00153 mg (0.153 percent) of ivermectin.
    (b) Sponsors. See sponsors in Sec. 510.600(c) of this chapter for 
use as in paragraph (e) of this section:
    (1) No. 000010 for use of a 1.87 percent paste as in (e)(1) of this 
section and a 0.153 percent paste for use as in paragraph (e)(2) of this 
section.
    (2) Nos. 051311, 054925, 058198, and 061133 for use of a 1.87 
percent paste for use as in paragraph (e)(1) of this section.

[[Page 199]]

    (c) Related tolerances. See Sec. 556.344 of this chapter.
    (d) Special considerations. See Sec. 500.25 of this chapter.
    (e) Conditions of use--(1) Horses--(i) Amount. 200 micrograms per 
kilogram (91 micrograms per pound) of body weight.
    (ii) Indications for use. For treatment and control of Large 
Strongyles (adults): Strongylus vulgaris (also early forms in blood 
vessels), S. edentatus (also tissue stages), S. equinus, Triodontophorus 
spp. including T. brevicauda and T. serratus, and Craterostomum 
acuticaudatum; Small Strongyles (adults, including those resistant to 
some benzimidazole class compounds): Coronocyclus spp. including C. 
coronatus, C. labiatus, and C. labratus, Cyathostomum spp. including C. 
catinatum and C. pateratum, Cylicocyclus spp. including C. insigne, C. 
leptostomum, C. nassatus, and C. brevicapsulatus, Cylicodontophorus 
spp., Cylicostephanus spp. including C. calicatus, C. goldi, C. 
longibursatus, and C. minutus, and Petrovinema poculatum; Small 
Strongyles (fourth-stage larvae); Pinworms (adults and fourth-stage 
larvae): Oxyuris equi; Ascarids (adults and third- and fourth-stage 
larvae): Parascaris equorum; Hairworms (adults): Trichostrongylus axei; 
Large mouth Stomach Worms (adults): Habronema muscae; Bots (oral and 
gastric stages): Gasterophilus spp. including G. intestinalis and G. 
nasalis; Lungworms (adults and fourth-stage larvae): Dictyocaulus 
arnfieldi; Intestinal Threadworms (adults): Strongyloides westeri; 
Summer Sores caused by Habronema and Draschia spp. cutaneous third-stage 
larvae; Dermatitis caused by neck threadworm microfilariae, Onchocerca 
sp.
    (iii) Limitations. For oral use only. Do not use in horses intended 
for human consumption.
    (2) Cattle--(i) Amount. 23 milligrams per 250 pounds of body weight.
    (ii) Indications for use. It is used in cattle for the treatment and 
control of gastrointestinal roundworms (adults and fourth-stage larvae) 
(Ostertagia ostertagi (including inhibited forms), O. lyrata, Haemonchus 
placei, Trichostrongylus axei, T. colubriformis, Cooperia oncophora, C. 
punctata, Nematodirus helvetianus, Bunostomum phlebotomum, Strongyloides 
papillosus (adults only), Oesophagostomum radiatum, Trichuris ovis 
(adults only)); lungworms (adults and fourth-stage larvae) (Dictyocaulus 
viviparus); grubs (first, second, and third instars) (Hypoderma bovis, 
H. lineatum); and sucking lice (Linognathus vituli, Haematopinus 
eurysternus).
    (iii) Limitations. For oral use only. Do not treat cattle within 24 
days of slaughter. Because withdrawal time in milk has not been 
established, do not use in female dairy cattle of breeding age.

[49 FR 22275, May 29, 1984, as amended at 50 FR 27819, July 8, 1985; 51 
FR 44449, Dec. 10, 1986; 53 FR 51273, Dec. 21, 1988; 62 FR 63270, Nov. 
28, 1997; 65 FR 70661, Nov. 27, 2000; 67 FR 71820, Dec. 3, 2002; 68 FR 
43294, July 22, 2003; 69 FR 59131, Oct. 4, 2004; 70 FR 8514, Feb. 22, 
2005; 71 FR 40010, July 14, 2006; 71 FR 67298, Nov. 21, 2006; 73 FR 
34184, June 17, 2008; 74 FR 6542, Feb. 10, 2009; 78 FR 17596, Mar. 22, 
2013; 84 FR 8972, Mar. 13, 2019; 84 FR 39183, Aug. 9, 2019; 86 FR 14818, 
Mar. 19, 2021]



Sec. 520.1193  Ivermectin tablets and chewables.

    (a) Specifications. (1) Each tablet or chewable contains 68, 136, or 
272 micrograms (mcg) ivermectin.
    (2) Each chewable contains 55 or 165 mcg ivermectin.
    (b) Sponsors. See sponsors in Sec. 510.600(c) of this chapter for 
use as in paragraph (d) of this section.
    (1) No. 000010 for use of tablets or chewables described in 
paragraph (a)(1) as in paragraph (d)(1) and chewables described in 
paragraph (a)(2) as in paragraph (d)(2) of this section.
    (2) Nos. 051311 and 069043 for use of tablets described in paragraph 
(a)(1) as in paragraph (d)(1) of this section.
    (c) Special considerations. Federal law restricts this drug to use 
by or on the order of a licensed veterinarian.
    (d) Conditions of use--(1) Dogs. For use in dogs 6 weeks of age and 
older as follows:
    (i) Amount. 6.0 mcg per kilogram (kg) of body weight (2.72 mcg per 
pound (lb)), minimum. Up to 25 lb, 68 mcg; 26 to 50 lb, 136 mcg; 51 to 
100 lb, 272 mcg; over 100 lb, a combination of the appropriate tablets. 
Administer at monthly dosing intervals.

[[Page 200]]

    (ii) Indications for use. To prevent canine heartworm disease by 
eliminating the tissue stage of heartworm larvae (Dirofilaria immitis) 
for 1 month (30 days) after infection.
    (2) Cats. For use in cats 6 weeks of age and older as follows:
    (i) Amount. Up to 2.3 kilograms (up to 5 lb), 55 mcg; 2.3 to 6.8 
kilograms (5 to 15 lb), 165 mcg; over 6.8 kilograms (15 lb), a 
combination of the appropriate chewables (recommended minimum dose of 24 
mcg/kg of body weight (10.9 mcg/lb)). Administer once a month.
    (ii) Indications for use. To prevent feline heartworm disease by 
eliminating the tissue stage of heartworm larvae Dirofilaria immitis for 
a month (30 days) after infection, and for removal and control of adult 
and immature (L4) hookworms Ancylostoma tubaeforme and A. braziliense.

[67 FR 11230, Mar. 13, 2002, as amended at 67 FR 21996, May 2, 2002; 69 
FR 43735, July 22, 2004; 81 FR 17607, Mar. 30, 2016; 84 FR 39183, Aug. 
9, 2019]



Sec. 520.1194  Ivermectin meal.

    (a) Specifications. Each gram of meal contains 6 milligrams 
ivermectin (0.6 percent).
    (b) Sponsor. See No. 017135 in Sec. 510.600(c) of this chapter.
    (c) Special considerations. See Sec. 500.25 of this chapter.
    (d) Conditions of use in horses--(1) Amount. Administer 136 
micrograms (mcg) ivermectin per pound (/lb) body weight (300 mcg/
kilogram) as a single dose on approximately 2 lb grain or sweet feed.
    (2) Indications for use. For treatment and control of Large 
Strongyles (adults): Strongylus vulgaris (also early forms in blood 
vessels), S. edentatus (also tissue stages), S. equinus, Triodontophorus 
spp. including T. brevicauda and T. serratus, and Craterostomum 
acuticaudatum; Small Strongyles (adults, including those resistant to 
some benzimidazole class compounds): Coronocyclus spp. including C. 
coronatus, C. labiatus, and C. labratus, Cyathostomum spp. including C. 
catinatum and C. pateratum, Cylicocyclus spp. including C. insigne, C. 
leptostomum, C. nassatus, and C. brevicapsulatus, Cylicodontophorus 
spp., Cylicostephanus spp. including C. calicatus, C. goldi, C. 
longibursatus, and C. minutus, and Petrovinema poculatum; Small 
Strongyles (fourth-stage larvae); Pinworms (adults and fourth stage 
larvae): Oxyuris equi; Ascarids (adults and third- and fourth-stage 
larvae): Parascaris equorum; Hairworms (adults): Trichostrongylus axei; 
Large Mouth Stomach Worms (adults): Habronema muscae; Bots (oral and 
gastric stages): Gasterophilus spp. including G. intestinalis and G. 
nasalis; Lungworms (adults and fourth-stage larvae): Dictyocaulus 
arnfieldi; Intestinal Threadworms (adults): Strongyloides westeri; 
Summer Sores caused by Habronema and Draschia spp. cutaneous third-stage 
larvae; Dermatitis caused by neck threadworm microfilariae, Onchocerca 
sp.
    Limitations. Do not use in horses intended for human consumption.

[70 FR 1817, Jan. 11, 2005, as amended at 70 FR 19262, Apr. 13, 2005]



Sec. 520.1195  Ivermectin liquid.

    (a) Specifications. (1) Each milliliter (mL) contains 10 milligrams 
(mg) ivermectin.
    (2) Each mL of micellar solution contains 0.8 mg ivermectin.
    (b) Sponsors. See sponsor numbers in Sec. 510.600(c) of this 
chapter.
    (1) Nos. 000010, 054925, 058005, and 058198 for use of product 
described in paragraph (a)(1) of this section as in paragraphs 
(e)(1)(i), (e)(1)(ii)(A), and (e)(1)(iii) of this section.
    (2) No. 058829 for use of product described in paragraph (a)(1) of 
this section as in paragraphs (e)(1)(i), (e)(1)(ii)(B), and (e)(1)(iii) 
of this section.
    (3) Nos. 000010 and 058829 for use of product described in paragraph 
(a)(2) of this section as in paragraph (e)(2) of this section.
    (c) Related tolerances. See Sec. 556.344 of this chapter.
    (d) Special considerations. See Sec. 500.25 of this chapter.
    (e) Conditions of use--(1) Horses--(i) Amount. 200 micrograms (mcg) 
per kilogram (/kg) of body weight as a single dose by stomach tube or as 
an oral drench.
    (ii) Indications for use. For treatment and control of:

[[Page 201]]

    (A) Large Strongyles (adults): Strongylus vulgaris (also early forms 
in blood vessels), S. edentatus (also tissue stages), S. equinus, 
Triodontophorus spp. including T. brevicauda and T. serratus, and 
Craterostomum acuticaudatum; Small Strongyles (adults, including those 
resistant to some benzimidazole class compounds): Coronocyclus spp. 
including C. coronatus, C. labiatus, and C. labratus, Cyathostomum spp. 
including C. catinatum and C. pateratum, Cylicocyclus spp. including C. 
insigne, C. leptostomum, C. nassatus, and C. brevicapsulatus, 
Cylicodontophorus spp., Cylicostephanus spp. including C. calicatus, C. 
goldi, C. longibursatus, and C. minutus, and Petrovinema poculatum; 
Small Strongyles (fourth-stage larvae); Pinworms (adults and fourth 
stage larvae): Oxyuris equi; Ascarids (adults and third- and fourth-
stage larvae): Parascaris equorum; Hairworms (adults): Trichostrongylus 
axei; Large mouth Stomach Worms (adults): Habronema muscae; Bots (oral 
and gastric stages): Gasterophilus spp. including G. intestinalis and G. 
nasalis; Lungworms (adults and fourth-stage larvae): Dictyocaulus 
arnfieldi; Intestinal Threadworms (adults), Strongyloides westeri; 
Summer Sores caused by Habronema and Draschia spp. cutaneous third-stage 
larvae; Dermatitis caused by neck threadworm microfilariae, Onchocerca 
sp.
    (B) Large Strongyles (Strongylus equinus (adult), S. vulgaris (adult 
and arterial larval stages), S. endentatus (adult and migrating tissue 
stages), Triodontophorus spp. (adult)); Small Strongyles including those 
resistant to some benzimidazole class compounds (Cyathostomum spp. 
(adult and fourth-stage larvae), Cylicocyclus spp., Cylicodontophorus 
spp., Cylicostephanus spp.); Pinworms (Oxyuris equi (adult and fourth-
stage larvae)); Ascarids (Parascaris equorum (adult and third- and 
fourth-stage larvae)); Hairworms (Trichostongylus axei ( adult)); Large 
mouth Stomach Worms (Habronema muscae (adult)); Stomach Bots 
(Gastrophilus spp. (oral and gastric stages)); Lungworms (Dictyocaulus 
arnfieldi (adult and fourth-stage larvae)); intestinal threadworms 
(Strongyloides westeri (adult)); Summer Sores caused by Habronema and 
Draschia spp. cutaneous third-stage larvae; and Dermatitis caused by 
neck threadworm microfilariae (Onchocerca spp.).
    (iii) Limitations. Do not use in horses intended for human 
consumption. Federal law restricts this drug to use by or on the order 
of a licensed veterinarian.
    (2) Sheep--(i) Amount. 200 mcg/kg (3 mL/26 pounds) of body weight as 
a single dose oral drench.
    (ii) Indications for use. For treatment and control of the adult and 
fourth-stage larvae of gastrointestinal roundworms (Haemonchus 
contortus, H. placei (adults only), Ostertagia circumcincta, 
Trichostrongylus axei, T. colubriformis, Cooperia oncophora (adults 
only), C. curticei, Oesophagostomum columbianum, O. venulosum (adults 
only), Nematodirus battus, N. spathiger, S. papillosus (adults only), 
Chabertia ovina (adult only), Trichuris ovis (adults only)); lungworms 
(D. filaria); and all larval stages of the nasal bot Oestrus ovis.
    (iii) Limitations. For use in sheep only. Do not use in other animal 
species as severe adverse reactions, including fatalities in dogs, may 
result. Do not treat sheep within 11 days of slaughter.

[67 FR 50597, Aug. 5, 2002, as amended at 69 FR 57173, Sept. 24, 2004; 
71 FR 13542, Mar. 16, 2006; 71 FR 38072, July 5, 2006; 72 FR 9456, Feb. 
21, 2008; 78 FR 17596, Mar. 22, 2013; 79 FR 10964, Feb. 27, 2014; 84 FR 
39183, Aug. 9, 2019; 86 FR 14818, Mar. 19, 2021]



Sec. 520.1196  Ivermectin and pyrantel tablets.

    (a) Specifications. Each chewable tablet contains either 68 
micrograms ([micro]g) of ivermectin and 57 milligrams (mg) of pyrantel 
(as pamoate salt), or 136 [micro]g and 114 mg, or 272 [micro]g and 227 
mg, respectively.
    (b) Sponsors. See Nos. 000010, 051311, and 063604 in Sec. 
510.600(c) of this chapter.
    (c) Conditions of use--(1) Dogs--(i) Amount. Administer a minimum of 
6 [micro]g of ivermectin and 5 mg of pyrantel per kilogram (2.72 
[micro]g and 2.27 mg per pound) of body weight monthly.
    (ii) Indications for use. To prevent canine heartworm disease by 
eliminating the tissue larval stages of Dirofilaria immitis for up to a 
month (30 days) after infection and treatment and control of

[[Page 202]]

adult ascarids Toxocara canis and Toxascaris leonina, and adult 
hookworms Ancylostoma caninum, A. braziliense, and Uncinaria 
stenocephala.
    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.
    (2) [Reserved]

[58 FR 8542, Feb. 16, 1993, as amended at 61 FR 15186, Apr. 5, 1996; 61 
FR 59004, Nov. 20, 1996; 62 FR 63270, Nov. 28, 1997; 66 FR 35756, July 
9, 2001; 67 FR 21996, May 2, 2002; 68 FR 55823, Sept. 29, 2003; 78 FR 
28822, May 20, 2014; 84 FR 39183, Aug. 9, 2019]



Sec. 520.1197  Ivermectin sustained-release bolus.

    (a) Specifications. Each sustained-release bolus contains 1.72 grams 
of ivermectin.
    (b) Sponsor. See No. 000010 in Sec. 510.600(c) of this chapter.
    (c) Related tolerances. See Sec. 556.344 of this chapter.
    (d) Conditions of use in ruminating calves--(1) Amount. Administer 
one bolus per calf weighing at least 275 pounds (lb) (125 kilograms 
(kg)) and not more than 660 lb (300 kg) on the day of administration.
    (2) Indications. For treatment and control, throughout the grazing 
season (approximately 130 days), of gastrointestinal roundworms 
Haemonchus placei, Ostertagia ostertagi (including inhibited fourth-
stage larvae), Trichostrongylus axei, T. colubriformis, Cooperia spp., 
Nematodirus helvetianus, Bunostomum phlebotomum, Oesophagostomum 
radiatum; lungworms Dictyocaulus viviparus; grubs Hypoderma spp.; 
sucking lice Linognathus vituli, Solenopotes capillatus; mange mites 
Psoroptes ovis, Sarcoptes scabiei, and ticks Amblyomma americanum.
    (3) Limitations. The bolus was specifically designed for use in 
cattle; do not use in other animal species. Calves must be ruminating 
and older than 12 weeks of age. Do not administer to calves weighing 
less than 275 lb (125 kg). Do not administer a damaged bolus. Because a 
milk withdrawal time has not been established, do not use in female 
dairy cattle of breeding age. Do not slaughter cattle within 180 days of 
treatment. Consult your veterinarian for assistance in the diagnosis, 
treatment, and control of parasitism.

[61 FR 67452, Dec. 23, 1996, as amended at 62 FR 63270, Nov. 28, 1997; 
65 FR 45876, July 26, 2000; 84 FR 39183, Aug. 9, 2019]



Sec. 520.1198  Ivermectin and praziquantel paste.

    (a) Specifications. Each milligram (mg) of paste contains:
    (1) 0.0155 mg (1.55 percent) ivermectin and 0.0775 mg (7.75 percent) 
praziquantel.
    (2) 0.0187 mg (1.87 percent) ivermectin and 0.1403 mg (14.03 
percent) praziquantel.
    (3) 0.0187 mg (1.87 percent) ivermectin and 0.2338 mg (23.38 
percent) praziquantel.
    (b) Sponsors. See sponsors in Sec. 510.600(c) of this chapter for 
uses as in paragraph (d) of this section.--
    (1) No. 000010 for use of product described in paragraph (a)(1) of 
this section as in paragraphs (d)(1)(i), (d)(2)(i) and (d)(3) of this 
section.
    (2) No. 051311 for use of product described in paragraph (a)(2) of 
this section as in paragraphs (d)(1)(ii), (d)(2)(ii), and (d)(3) of this 
section.
    (3) No. 000010 for use of products described in paragraph (a)(3) of 
this section as in paragraphs (d)(1)(iii), (d)(2)(iii) and (d)(3) of 
this section.
    (c) Special considerations. See Sec. 500.25 of this chapter.
    (d) Conditions of use in horses--(1) Amount. (i) 200 micrograms 
(mcg) per kilogram (/kg) ivermectin (91 mcg per pound (/lb)) and 1 mg/kg 
praziquantel (454 mcg/lb) body weight.
    (ii) 200 mcg/kg ivermectin (91 mcg/lb) and 1.5 mg/kg praziquantel 
(681 mcg/lb) body weight.
    (iii) 200 mcg/kg ivermectin (91 mcg/lb) and 2.5 mg/kg praziquantel 
(1.14 mg/lb).
    (2) Indications for use. (i) For treatment and control of the 
following parasites: Tapeworms--Anoplocephala perfoliata; Large 
Strongyles (adults)--Strongylus vulgaris (also early forms in blood 
vessels), S. edentatus (also tissue stages), S. equinus, Triodontophorus 
spp. including T. brevicauda and T. serratus, and Craterostomum 
acuticaudatum; Small Strongyles (adults, including those resistant to 
some benzimidazole class compounds)--Coronocyclus spp. including C. 
coronatus, C. labiatus, and C.

[[Page 203]]

labratus; Cyathostomum spp. including C. catinatum and C. pateratum; 
Cylicocyclus spp. including C. insigne, C. leptostomum, C. nassatus, and 
C. brevicapsulatus; Cylicodontophorus spp.; Cylicostephanus spp. 
including C. calicatus, C. goldi, C. longibursatus, and C. minutus, and 
Petrovinema poculatum; Small Strongyles--fourth-stage larvae; Pinworms 
(adults and fourth-stage larvae)--Oxyuris equi; Ascarids (adults and 
third- and fourth-stage larvae)--Parascaris equorum; Hairworms 
(adults)--Trichostrongylus axei; Large-mouth Stomach Worms (adults)--
Habronema muscae; Bots (oral and gastric stages)--Gasterophilus spp. 
including G. intestinalis and G. nasalis; Lungworms (adults and fourth-
stage larvae)--Dictyocaulus arnfieldi; Intestinal Threadworms (adults)--
Strongyloides westeri; Summer Sores caused by Habronema and Draschia 
spp. cutaneous third-stage larvae; Dermatitis caused by neck threadworm 
microfilariae of Onchocerca sp.
    (ii) For treatment and control of the following parasites: 
Tapeworms--Anoplocephala perfoliata; Large Strongyles (adults)--
Strongylus vulgaris (also early forms in blood vessels), S. edentatus 
(also tissue stages), S. equinus, Triodontophorus spp.; Small Strongyles 
(adults, including those resistant to some benzimidazole class 
compounds)--Cyathostomum spp.; Cylicocyclus spp.; Cylicostephanus spp., 
Cylicodontophorus spp.; Small Strongyles--fourth-stage larvae; Pinworms 
(adults and fourth-stage larvae)--Oxyuris equi; Ascarids (adults and 
third- and fourth-stage larvae)--Parascaris equorum; Hairworms 
(adults)--Trichostrongylus axei; Large-mouth Stomach Worms (adults)--
Habronema muscae; Bots (oral and gastric stages)--Gasterophilus spp.; 
Lungworms (adults and fourth-stage larvae)--Dictyocaulus arnfieldi; 
Intestinal Threadworms (adults)--Strongyloides westeri; Summer Sores 
caused by Habronema and Draschia spp. cutaneous third-stage larvae; 
Dermatitis caused by neck threadworm microfilariae, Onchocerca sp.
    (iii) For treatment and control of the following parasites in horses 
over 5 months of age: Tapeworms--Anoplocephala perfoliata; Large 
Strongyles (adults)--Strongylus vulgaris (also early forms in blood 
vessels), S. edentatus (also tissue stages), S. equinus, Triodontophorus 
spp. including T. brevicauda and T. serratus, and Craterostomum 
acuticaudatum; Small Strongyles (adults, including those resistant to 
some benzimidazole class compounds)--Coronocyclus spp. including C. 
coronatus, C. labiatus, and C. labratus; Cyathostomum spp. including C. 
catinatum and C. pateratum; Cylicocyclus spp. including C. insigne, C. 
leptostomum, C. nassatus, and C. brevicapsulatus; Cylicodontophorus 
spp.; Cylicostephanus spp. including C. calicatus, C. goldi, C. 
longibursatus, and C. minutus, and Petrovinema poculatum; Small 
Strongyles--fourth-stage larvae; Pinworms (adults and fourth-stage 
larvae)--Oxyuris equi; Ascarids (adults and third- and fourth-stage 
larvae)--Parascaris equorum; Hairworms (adults)--Trichostrongylus axei; 
Large-mouth Stomach Worms (adults)--Habronema muscae; Bots (oral and 
gastric stages)--Gasterophilus spp. including G. intestinalis and G. 
nasalis; Lungworms (adults and fourth-stage larvae)--Dictyocaulus 
arnfieldi; Intestinal Threadworms (adults)--Strongyloides westeri; 
Summer Sores caused by Habronema and Draschia spp. cutaneous third-stage 
larvae; Dermatitis caused by neck threadworm microfilariae of Onchocerca 
sp.
    (3) Limitations. For oral use only. Do not use in horses intended 
for human consumption.

[68 FR 55309, Sept. 25, 2003, as amended at 69 FR 49808, Aug. 12, 2004; 
70 FR 65835, Nov. 1, 2005; 79 FR 37619, July 2, 2014; 84 FR 39183, Aug. 
9, 2019]



Sec. 520.1199  Ivermectin, pyrantel, and praziquantel tablets.

    (a) Specifications. Each chewable tablet or soft chewable tablet 
contains:
    (1) 34 micrograms (mcg) ivermectin, 28.5 milligrams (mg) pyrantel 
pamoate, and 28.5 mg praziquantel;
    (2) 68 mcg ivermectin, 57 mg pyrantel pamoate, and 57 mg 
praziquantel;
    (3) 136 mcg ivermectin, 114 mg pyrantel pamoate, and 114 mg 
praziquantel; or
    (4) 272 mcg ivermectin, 228 mg pyrantel pamoate, and 228 mg 
praziquantel.

[[Page 204]]

    (b) Sponsor. See No. 051311 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in dogs--(1) Amount. Administer monthly 
according to body weight as follows:
    (i) 6 to 12 lb: one tablet as described in paragraph (a)(1) of this 
section.
    (ii) 12.1 to 25 lb: one tablet as described in paragraph (a)(2) of 
this section.
    (iii) 25.1 to 50 lb: one tablet as described in paragraph (a)(3) of 
this section.
    (iv) 50.1 to 100 lb: one tablet as described in paragraph (a)(4) of 
this section.
    (v) Greater than 100 lb: use the appropriate combination of tablets.
    (2) Indications for use. To prevent canine heartworm disease by 
eliminating the tissue stage of heartworm larvae (Dirofilaria immitis) 
for 1 month (30 days) after infection and for the treatment and control 
of roundworm (Toxocara canis, Toxascaris leonina), hookworm (Ancylostoma 
caninum, Uncinaria stenocephala, Ancylostoma braziliense) and tapeworm 
(Dipylidium caninum, Taenia pisiformis) infections.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[71 FR 65052, Nov. 7, 2006, as amended at 78 FR 28822, May 20, 2014; 83 
FR 14587, Apr. 5, 2018]



Sec. 520.1200  Ivermectin, fenbendazole, and praziquantel tablets.

    (a) Specifications. Each chewable tablet contains either:
    (1) 68 micrograms ([micro]g) ivermectin, 1.134 grams fenbendazole, 
and 57 milligrams (mg) praziquantel; or
    (2) 27 [micro]g ivermectin, 454 mg fenbendazole, and 23 mg 
praziquantel.
    (b) Sponsor. See No. 000061 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in dogs--(1) Amount. Administer tablets to 
provide 6 [micro]g per kilogram (/kg) ivermectin, 100 mg/kg 
fenbendazole, and 5 mg/kg praziquantel.
    (2) Indications for use. For the treatment and control of adult 
Toxocara canis (roundworm), Ancylostoma caninum (hookworm), Trichuris 
vulpis (whipworm), and Dipylidium caninum (tapeworm), and for the 
prevention of heartworm disease caused by Dirofilaria immitis in adult 
dogs.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[73 FR 33692, June 13, 2008, as amended at 74 FR 61516, Nov. 25, 2009]



Sec. 520.1204  Kanamycin, bismuth subcarbonate, activated attapulgite.

    (a) Specifications. (1) Each 5 milliliters (mL) of suspension 
contains 100 milligrams (mg) kanamycin (as the sulfate), 250 mg bismuth 
subcarbonate, and 500 mg activated attapulgite (aluminum magnesium 
silicate).
    (2) Each tablet contains 100 mg kanamycin (as the sulfate), 250 mg 
bismuth subcarbonate, and 500 mg activated attapulgite.
    (b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in dogs--(1) Amount. 5 mL of suspension or 1 
tablet per 20 pounds body weight every 8 hours. Maximum dose: 5 mL of 
suspension or 3 tablets every 8 hours. Dogs under 10 pounds: 2.5 mL of 
suspension or \1/2\ tablet every 8 hours. A recommended initial loading 
dose should be twice the amount of a single dose.
    (2) Indications for use. For the treatment of bacterial enteritis 
caused by organisms susceptible to kanamycin and the symptomatic relief 
of the associated diarrhea.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[40 FR 13838, Mar. 27, 1975, as amended at 53 FR 27851, July 25, 1988; 
56 FR 8710, Mar. 1, 1991; 64 FR 403, Jan. 5, 1999; 71 FR 43968, Aug. 3, 
2006; 78 FR 28822, May 20, 2014]



Sec. 520.1242  Levamisole.



Sec. 520.1242a  Levamisole powder.

    (a) Specifications. Each package of powder contains 9.075, 11.7, 
18.15, 46.8, 362.7, or 544.5 grams (g) levamisole hydrochloride.
    (b) Sponsors. See sponsors in Sec. 510.600(c) for use as follows:
    (1) No. 000061 for use of 46.8- and 544.5-g packages as in paragraph 
(e)(1)(i), (e)(1)(ii)(B), and (e)(1)(iii) of this section; for 11.7-, 
46.8-, and 544.5-g packages as in paragraph (e)(2)(i),

[[Page 205]]

(e)(2)(ii)(B), and (e)(2)(iii) of this section; and for an 18.15-g 
package as in paragraph (e)(3) of this section.
    (2) No. 054771 for use of a 46.8-g package as in paragraph 
(e)(1)(i), (e)(1)(ii)(A), and (e)(1)(iii) of this section; for 11.7- and 
46.8-g packages as in paragraph (e)(2)(i), (e)(2)(ii)(A), and 
(e)(2)(iii) of this section; and for 9.075- and 18.15-g packages as in 
paragraph (e)(3) of this section.
    (3) No. 016592 for use of 46.8- and 544.5-g packages as in 
paragraphs (e)(1)(i), (e)(1)(ii)(A), and (e)(1)(iii) and (e)(2)(i), 
(e)(2)(ii)(A), and (e)(2)(iii) of this section.
    (4) No. 061133 for use of 46.8-, 362.7-, and 544.5-g packages as in 
paragraphs (e)(1)(i), (e)(1)(ii)(B), (e)(1)(iii), (e)(2)(i), 
(e)(2)(ii)(B), and (e)(2)(iii) of this section; and for use of an 18.15-
g package as in paragraph (e)(3) of this section.
    (c) Related tolerances. See Sec. 556.350 of this chapter.
    (d) Special considerations. See Sec. 500.25 of this chapter.
    (e) Conditions of use. It is used as an anthelmintic as follows:
    (1) Cattle--(i) Amount. 8 milligrams per kilogram (mg/kg) body 
weight as a drench.
    (ii) Indications for use. (A) Effective against the following 
nematode infections: Stomach worms (Haemonchus, Trichostrongylus, 
Ostertagia); intestinal worms (Trichostrongylus, Cooperia, Nematodirus, 
Bunostomum, Oesophagostomum); and lungworms (Dictyocaulus).
    (B) Effective against the following adult nematode infections: 
Stomach worms (Haemonchus placei, Ostertagia ostertagi, Trichostrongylus 
axei); intestinal worms (T. longispicularis, Cooperia oncophora, C. 
punctata, Nematodirus spathiger, Bunostomum phlebotomum, Oesophagostomum 
radiatum); and lungworms (Dictyocaulus viviparus).
    (iii) Limitations. Do not slaughter for food within 48 hours of 
treatment. Not for use in dairy animals of breeding age. Conditions of 
constant helminth exposure may require retreatment 2 to 4 weeks after 
the first treatment. Consult your veterinarian before using in severely 
debilitated animals.
    (2) Sheep--(i) Amount. 8 mg/kg body weight as a drench.
    (ii) Indications for use. (A) Effective against the following 
nematode infections: Stomach worms (Haemonchus, Trichostrongylus, 
Ostertagia); intestinal worms (Trichostrongylus, Cooperia, Nematodirus, 
Bunostomum, Oesophagostomum, Chabertia); and lungworms (Dictyocaulus).
    (B) Effective against the following adult nematode infections: 
Stomach worms (Haemonchus contortus, Trichostrongylus axei, Teladorsagia 
circumcincta); intestinal worms (Trichostrongylus colubriformis, 
Cooperia curticei, Nematodirus spathiger, Bunostomum trigonocephalum, 
Oesophagostomum columbianum, Chabertia ovina), and lungworms 
(Dictyocaulus filaria).
    (iii) Limitations. Do not slaughter for food within 72 hours of 
treatment. Conditions of constant helminth exposure may require 
retreatment 2 to 4 weeks after the first treatment. Consult veterinarian 
before using in severely debilitated animals.
    (3) Swine--(i) Amount. 8 mg/kg body weight in drinking water.
    (ii) Indications for use. Effective against the following nematode 
infections: Large roundworms (Ascaris suum), nodular worms 
(Oesophagostomum spp.), intestinal thread worms (Strongyloides ransomi) 
and lungworms (Metastrongylus spp. ).
    (iii) Limitations. Do not administer within 72 hours of slaughter 
for food. Pigs maintained under conditions of constant exposure to worms 
may require retreatment within 4 to 5 weeks after the first treatment. 
Consult your veterinarian before administering to sick swine.

[69 FR 9753, Mar. 2, 2004, as amended at 69 FR 33839, June 17, 2004; 70 
FR 2353, Jan. 13, 2005; 77 FR 28253, May 14, 2012; 78 FR 28822, May 20, 
2014; 83 FR 48945, Sept. 28, 2018; 84 FR 8972, Mar. 13, 2019]



Sec. 520.1242b  Levamisol boluses or oblets.

    (a) Specifications. Each bolus contains 2.19 grams levamisol 
hydrochloride. Each oblet contains 0.184 grams levamisol hydrochloride.
    (b) Sponsors. See Nos. 000061 and 054771 in Sec. 510.600(c) of this 
chapter.

[[Page 206]]

    (c) Required labeling. Consult your veterinarian for assistance in 
the diagnosis, treatment, and control of parasitism.
    (d) Related tolerances. See Sec. 556.350 of this chapter.
    (e) Conditions of use--(1) Cattle--(i) Amount. Administer orally 
2.19-gram boluses as a single dose as follows: 250 to 450 pounds, \1/2\ 
bolus; 450 to 750 pounds, 1 bolus; and 750 to 1,050 pounds, 1\1/2\ 
boluses.
    (ii) Indications for use. Anthelmintic effective against the 
following nematode infections: Stomach worms (Haemonchus, 
Trichostrongylus, Ostertagia), intestinal worms (Trichostrongylus, 
Cooperia, Nematodirus, Bunostomum, Oesophagostomum), and lungworms 
(Dictyocaulus).
    (iii) Limitations. Conditions of constant helminth exposure may 
require re-treatment within 2 to 4 weeks after the first treatment. Do 
not slaughter for food within 48 hours of treatment. Not for use in 
dairy animals of breeding age. Consult veterinarian before using in 
severely debilitated animals.
    (2) Sheep--(i) Amount. Administer orally one 0.184-gram oblet for 
each 50 pounds of body weight.
    (ii) Indications for use. Anthelmintic effective against the 
following nematode infections: Stomach worms (Haemonchus, 
Trichostrongylus, Ostertagia), intestinal worms (Trichostrongylus, 
Cooperia, Nematodirus, Bunostomum, Oesophagostomum, Chabertia), and 
lungworms (Dictyocaulus).
    (iii) Limitations. Conditions of constant helminth exposure may 
require re-treatment within 2 to 4 weeks after the first treatment. Do 
not slaughter for food within 72 hours of treatment. Consult a 
veterinarian before using in severely debilitated animals.

[78 FR 28822, May 20, 2014]



Sec. 520.1242c  Levamisol and piperazine.

    (a) Specifications. (1) Each ounce of solution contains 0.36 gram of 
levamisole hydrochloride and piperazine dihydrochloride equivalent to 
3.98 grams of piperazine base.
    (2) A soluble powder which when constituted with water contains in 
each fluid ounce 0.45 gram of levamisole hydrochloride and piperazine 
dihydrochloride equivalent to 5.0 grams of piperazine base.
    (b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in horses--(1) Amount. Aqueous solution: 
administer by stomach tube or drench 1 fluid ounce per 100 pounds of 
body weight. Reconstituted soluble powder: administer by stomach tube 1 
fluid ounce per 125 pounds of body weight. If reinfection occurs, re-
treat animals at 6- to 8-week intervals.
    (2) Indications for use. An anthelmintic effective against 
infections of large strongyles (Strongylus vulgaris, S. edentatus), 
small strongyles (Cylicocercus spp., Cylicocyclus spp., 
Cylicodontophorus spp., Cylicostephanus spp., Cylicotetrapedon spp.), 
ascarids (Parascaris equorum), and pinworms (Oxyuris equi).
    (3) Limitations. Do not use in horses intended for human 
consumption. Federal law restricts this drug to use by or on the order 
of a licensed veterinarian.

[78 FR 28823, May 20, 2014]



Sec. 520.1242d  Levamisole resinate.

    (a) Specifications. The drug is levamisole adsorbed on a resin, in a 
concentration equivalent to 10 percent levamisole hydrochloride. Each 
2.05-ounce (58.1 gram) packet contains levamisole equivalent to 5.806 
grams of levamisole hydrochloride.
    (b) Sponsor. See No. 043781 in Sec. 510.600(c) of this chapter.
    (c) Related tolerances. See Sec. 556.350 of this chapter.
    (d) Conditions of use. In swine it is used as follows:
    (1) Amount. The equivalent of 8 milligrams per kilogram of body 
weight, as a single dose, mixed in the animal's ration.
    (2) Indications for use. For the removal of and control of the 
following nematode infections: large roundworms (Ascaris suum), nodular 
worms (Oesophagostomum spp.), lungworms (Metastrongylus spp.), 
intestinal threadworms (Strongyloides ransomi), and swine kidney worms 
(Stephanurus dentatum).
    (3) Limitations. For pigs from weaning to market weight, mix one 
58.1-gram

[[Page 207]]

packet of levamisole resinate containing the equivalent of 10-percent 
levamisole hydrochloride in 40 pounds of feed and administer 1 pound of 
medicated feed per 40 pounds of body weight as sole ration. For breeding 
swine, mix 1 packet of the 10-percent resinate in 16 pounds of feed and 
administer 1 pound of medicated feed per 100 pounds of body weight as 
sole ration. Administer as single doses. Withhold regular feed overnight 
and administer medicated feed the following morning. Do not withhold 
water during fasting. Do not treat within 72 hours of slaughter. 
Salivation or muzzle foam may be observed. The reaction will disappear a 
short time after feeding. If pigs are infected with mature lungworms, 
coughing and vomiting may be observed. Consult your veterinarian for 
assistance in the diagnosis, treatment, and control of parasitism.

[43 FR 18171, Apr. 28, 1978, as amended at 45 FR 3574, Jan. 18, 1980]



Sec. 520.1242e  Levamisole hydrochloride effervescent tablets.

    (a) Specifications. Each tablet contains 907 milligrams of 
levamisole hydrochloride.
    (b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
    (c) Related tolerances. See Sec. 556.350 of this chapter.
    (d) Conditions of use. It is used for swine as follows:
    (1) Amount. The equivalent of 8 milligrams of levamisole 
hydrochloride per kilogram of body weight, as a single dose.
    (2) Indications for use. See Sec. 520.1242a(f)(3)(ii).
    (3) Limitations. Withholding water from pigs before treatment is not 
necessary. Add one tablet for each 2\1/2\ gallons of water; mix 
thoroughly. Allow 1 gallon of medicated water for each 100 pounds body 
weight of pigs to be treated. No other source of water should be 
offered. After pigs have consumed medicated water, resume use of regular 
water. Pigs maintained under conditions of constant worm exposure may 
require re-treatment within 4 to 5 weeks. Consult your veterinarian 
before administering to sick swine. Consult your veterinarian for 
assistance in the diagnosis, treatment, and control of parasitism. Do 
not administer within 72 hours of slaughter for food.

[45 FR 6087, Jan. 25, 1980, as amended at 67 FR 63055, Oct. 10, 2002; 78 
FR 28823, May 20, 2014]



Sec. 520.1242f  Levamisol gel.

    (a) Specifications. Each gram of gel contains 115 milligrams (11.5 
percent) levamisol hydrochloride.
    (b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
    (c) Related tolerances. See Sec. 556.350 of this chapter.
    (d) Conditions of use--(1) Cattle--(i) Amount. Eight milligrams of 
levamisole hydrochloride per kilogram of body weight, as a single oral 
dose.
    (ii) Indications for use. Anthelmintic effective against the 
following nematode infections: Stomach worms (Haemonchus, 
Trichostrongylus, Ostertagia), intestinal worms (Trichostrongylus, 
Cooperia, Nematodirus, Bunostomum, Oesophagostomum), and lungworms 
(Dictyocaulus).
    (iii) Limitations. Conditions of constant helminth exposure may 
require re-treatment within 2 to 4 weeks after the first treatment; do 
not administer to cattle within 6 days of slaughter for food; do not 
administer to dairy animals of breeding age; consult veterinarian before 
using in severely debilitated animals.
    (2) Breeding swine--(i) Amount. Eight milligrams per kilogram of 
body weight (3.6 milligrams per pound) as a single oral dose.
    (ii) Conditions of use. For treating breeding swine infected with 
the following nematodes: Large roundworms (Ascaris suum), nodular worms 
(Oesophagostomum spp.), lungworms (Metastrongylus spp.), intestinal 
threadworms (Strongyloides ransomi), and kidney worms (Stephanurus 
dentatus).
    (iii) Limitations. May require retreatment in 4 to 5 weeks. Do not 
use within 11 days of slaughter for food. Consult your veterinarian for 
assistance before using in severely debilitated animals

[[Page 208]]

and in the diagnosis, treatment, and control of parasitism.

[47 FR 22517, May 25, 1982; 47 FR 30242, July 13, 1982, as amended at 48 
FR 11429, Mar. 18, 1983; 51 FR 29215, Aug. 15, 1986; 67 FR 63055, Oct. 
10, 2002; 78 FR 28823, May 20, 2014]



Sec. 520.1242g  Levamisole resinate and famphur paste.

    (a) Specifications. The drug is a paste containing 11.6 percent 
levamisole resinate (50 percent potency) and 23.6 percent famphur.
    (b) Sponsor. See 000061 in Sec. 510.600(c) of this chapter.
    (c) Special considerations. Do not use any cholinesterase-inhibiting 
drugs, pesticides, insecticides, or chemicals on cattle simultaneously 
or within a few days before or after treatment with this product.
    (d) Related tolerances. See Sec. Sec. 556.273 and 556.350 of this 
chapter.
    (e) Conditions of use in cattle--(1) Amount. 8 milligrams of 
levamisole hydrochloride (equivalent) and 30 milligrams of famphur 
activity per kilogram of body weight.
    (2) Indications for use. For treatment of cattle infected with the 
following parasites: Stomach worms (Haemonchus, Trichostrongylus, 
Ostertagia), intestinal worms (Trichostrongylus, Cooperia, Nematodirus, 
Bunostomum, Oesophagostomum), lungworms (Dictyocaulus), cattle grubs 
(Hypoderma), biting lice (Bovicola), and sucking lice (Linognathus, 
Solenoptes).
    (3) Limitations. Drug is not effective against lice eggs. Conditions 
of constant helminth and ectoparasitic exposure may require retreatment 
within 2 to 4 weeks after first treatment. Do not administer to cattle 
within 19 days of slaughter. Do not administer to dairy animals of 
breeding age. Do not use in calves less than 3 months old, or in 
debilitated animals. Do not treat Brahman bulls. Consult your 
veterinarian for assistance in the diagnosis, treatment, and control of 
parasitism.

[53 FR 23757, June 24, 1988, as amended at 54 FR 1353, Jan. 13, 1989; 57 
FR 7652, Mar. 4, 1992; 62 FR 55160, Oct. 23, 1997; 62 FR 61625, Nov. 19, 
1997; 78 FR 28823, May 20, 2014]



Sec. 520.1248  Levothyroxine.

    (a) Specifications. Each tablet contains 0.1, 0.2, 0.3, 0.4, 0.5, 
0.6, 0.7, 0.8, or 1.0 milligrams (mg) levothyroxine sodium.
    (b) Sponsor. See No. 061690 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use--(1) Amount. Administer by mouth 0.1 mg/10 
pounds of body weight (0.022 mg/kilogram) as a single dose every 24 
hours or as a divided dose every 12 hours.
    (2) Indications for use. For replacement therapy for diminished 
thyroid function in dogs.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[81 FR 22523, Apr. 18, 2016]



Sec. 520.1263  Lincomycin.



Sec. 520.1263a  Lincomycin tablets and syrup.

    (a) Specifications. (1) Each ounce of syrup contains lincomycin 
hydrochloride equivalent to either 25 or 50 milligrams (mg) lincomycin.
    (2) Each tablet contains lincomycin hydrochloride equivalent to 
either 25 or 50 mg lincomycin.
    (b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in dogs and cats--(1) Amount. Administer 
orally 10 mg per pound of body weight every 12 hours, or 7 mg per pound 
of body weight every 8 hours, for up to 12 days.
    (2) Indications for use. For infections caused by gram-positive 
organisms which are sensitive to its action, particularly streptococci 
and staphylococci.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[78 FR 28823, May 20, 2014]



Sec. 520.1263b  Lincomycin powder.

    (a) Specifications. Each gram of soluble powder contains lincomycin 
hydrochloride equivalent to 0.4 grams of lincomycin.
    (b) Sponsors. See sponsor numbers in Sec. 510.600(c) of this 
chapter as follows:
    (1) No. 054771 for use as in paragraph (d) of this section.

[[Page 209]]

    (2) Nos. 016592, 054925, 061133, and 076475 for use as in paragraphs 
(d)(1) and (d)(2) of this section.
    (c) Tolerances. See Sec. 556.360 of this chapter.
    (d) Conditions of use--(1) Swine--(i) Amount. 250 milligrams per 
gallon of drinking water to provide 3.8 milligrams per pound of body 
weight per day.
    (ii) Indications for use. For the treatment of swine dysentery 
(bloody scours).
    (iii) Limitations. Discard medicated drinking water if not used 
within 2 days. Prepare fresh stock solution daily. Do not use for more 
than 10 days. If clinical signs of disease have not improved within 6 
days, discontinue treatment and reevaluate diagnosis. The safety of 
lincomycin has not been demonstrated in pregnant swine or swine intended 
for breeding. For No. 054925: Do not slaughter swine for 6 days 
following last treatment. Federal law restricts this drug to use by or 
on the order of a licensed veterinarian.
    (2) Chickens--(i) Amount. 64 milligrams per gallon of drinking 
water.
    (ii) Indications for use. For the control of necrotic enteritis 
caused by Clostridium perfringens susceptible to lincomycin in broiler 
chickens.
    (iii) Limitations. Discard medicated drinking water if not used 
within 2 days. Prepare fresh stock solution daily. Administer for 7 
consecutive days. Do not allow rabbits, hamsters, guinea pigs, horses, 
or ruminants access to water containing lincomycin. Not for use in layer 
and breeder chickens. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.
    (3) Honey bees--(i) Amount. Mix 100 milligrams lincomycin with 20 
grams confectioners'/powdered sugar and dust over the top bars of the 
brood chamber once weekly for 3 weeks.
    (ii) Indications for use. For the control of American foulbrood 
(Paenibacillus larvae).
    (iii) Limitations. The drug should be fed early in the spring or 
late in the fall and consumed by the bees before the main honey flow 
begins to avoid contamination of production honey. Complete treatments 
at least 4 weeks before main honey flow. Federal law restricts this drug 
to use by or on the order of a licensed veterinarian.

[48 FR 3966, Jan. 28, 1983, as amended at 55 FR 3209, Jan. 31, 1990; 60 
FR 14217, Mar. 16, 1995; 62 FR 65020, Dec. 10, 1997; 64 FR 13341, Mar. 
18, 1999; 64 FR 13508, Mar. 19, 1999; 64 FR 66382, Nov. 26, 1999; 65 FR 
10705, Feb. 29, 2000; 67 FR 17284, Apr. 10, 2002; 67 FR 71819, Dec. 3, 
2002; 67 FR 78356, Dec. 24, 2002; 68 FR 3817, Jan. 27, 2003; 70 FR 1818, 
Jan. 11, 2005; 77 FR 20988, Apr. 9, 2012; 77 FR 29217, May 17, 2012; 78 
FR 28823, May 20, 2014; 81 FR 22523, Apr. 18, 2016; 81 FR 94989, Dec. 
27, 2016; 83 FR 48945, Sept. 28, 2018; 84 FR 8972, Mar. 13, 2019. 
Redesignated at 85 FR 18119, Apr. 1, 2020]



Sec. 520.1265  Lincomycin and spectinomycin powder.

    (a) Specifications. The following salts of lincomycin and 
spectinomycin are present in a soluble powder in the ratio of 1 to 2 on 
the basis of equivalency of lincomycin base to equivalency of 
spectinomycin base:
    (1) Lincomycin hydrochloride monohydrate and spectinomycin sulfate 
tetrahydrate.
    (2) Lincomycin hydrochloride monohydrate and spectinomycin 
dihydrochloride pentahydrate.
    (b) Sponsors. See sponsors in Sec. 510.600(c) of this chapter for 
use as in paragraph (d) of this section.
    (1) No. 054771 for use of product described in paragraph (a)(1) of 
this section.
    (2) Nos. 016592, 061133, and 066104 for use of product described in 
paragraph (a)(2) of this section.
    (c) Tolerances. See Sec. Sec. 556.360 and 556.600 of this chapter.
    (d) Conditions of use in chickens--(1) Amount. 2 grams of antibiotic 
activity per gallon of drinking water; administer as the sole source of 
water for the first 5 to 7 days of life.
    (2) Indications for use. As an aid in the control of airsacculitis 
caused by either Mycoplasma synoviae or M. gallisepticum susceptible to 
lincomycin-spectinomycin and complicated chronic respiratory disease 
(air sac infection) caused by Escherichia coli and M. gallisepticum 
susceptible to lincomycin-spectinomycin.

[[Page 210]]

    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[69 FR 13220, Mar. 22, 2004, as amended at 70 FR 40881, July 15, 2005; 
71 FR 71038, Dec. 8, 2006; 77 FR 56770, Sept. 14, 2012; 78 FR 28823, May 
20, 2014; 81 FR 94989, Dec. 27, 2016; 83 FR 48945, Sept. 28, 2018; 84 FR 
8972, Mar. 13, 2019]



Sec. 520.1284  Liothyronine.

    (a) Specifications. Each tablet contains 60 or 120 micrograms 
([micro]g) liothyronine as the sodium salt.
    (b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in dogs--(1) Amount. Administer orally to dogs 
at levels up to 12.8 [micro]g per kilogram (/kg) of body weight per day. 
Dosage should be adjusted according to the severity of the condition and 
the response of the patient. Dosage at the total replacement level (12.8 
[micro]g/kg of body weight) should be considered for initiating therapy 
and then titrated downward for optimum maintenance effect. Twice daily 
administration is recommended.
    (2) Indications for use. For treatment of hypothyroidism in dogs.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[78 FR 28823, May 20, 2014]



Sec. 520.1286  Lotilaner.

    (a) Specifications. Each chewable tablet contains:
    (1) For use in dogs: 56.25, 112.5, 225, 450, or 900 milligrams (mg) 
lotilaner; or
    (2) For use in cats: 12 or 48 mg lotilaner.
    (b) Sponsor. See No. 058198 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use--(1) Dogs--(i) Amount. Administer orally once 
a month at the recommended minimum dosage of 9 mg/lb (20 mg/kg).
    (ii) Indications for use. Kills adult fleas, and for the treatment 
and prevention of flea infestations (Ctenocephalides felis), and the 
treatment and control of tick infestations (Amblyomma americanum (lone 
star tick), Dermacentor variabilis (American dog tick), Ixodes 
scapularis (black-legged tick), and Rhipicephalus sanguineus (brown dog 
tick)) for 1 month in dogs and puppies 8 weeks of age or older and 
weighing 4.4 pounds or greater.
    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.
    (2) Cats--(i) Amount. Administer orally once a month at the 
recommended minimum dosage of 2.7 mg/lb (6 mg/kg).
    (ii) Indications for use. Kills adult fleas, and for the treatment 
and prevention of flea infestations (Ctenocephalides felis) for 1 month 
in cats and kittens 8 weeks of age or older and weighing 2 pounds or 
greater.
    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

[85 FR 18119, Apr. 1, 2020]



Sec. 520.1288  Lufenuron tablets.

    (a) Specifications--(1) Tablets containing 45, 90, 204.9, or 409.8 
milligrams (mg) lufenuron for use as in paragraphs (c)(1)(i), 
(c)(1)(ii)(A), (c)(1)(iii), (c)(2)(i), (c)(2)(ii)(A), and (c)(2)(iii) of 
this section.
    (2) Flavored tablets containing 45, 90, 204.9, or 409.8 milligrams 
(mg) lufenuron for use as in paragraphs (c)(1)(i), (c)(1)(ii)(A) or 
(c)(1)(ii)(B), and (c)(1)(iii) of this section.
    (3) Flavored tablets containing 90 or 204.9 mg lufenuron for use as 
in paragraphs (c)(2)(i), (c)(2)(ii)(A) or (c)(2)(ii)(B), and (c)(2)(iii) 
of this section.
    (4) Flavored tablets containing 135 or 270 mg lufenuron for use as 
in paragraphs (c)(2)(i), (c)(2)(ii)(A), and (c)(2)(iii) of this section.
    (b) Sponsor. See No. 058198 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use--(1) Dogs--(i) Amount. Minimum of 10 mg 
lufenuron per kilogram (4.5 mg per pound (lb)) of body weight, once a 
month.
    (ii) Indications for use--(A) For the prevention and control of flea 
populations.
    (B) The concurrent use of flavored lufenuron tablets described in 
paragraph (a)(2) of this section as in paragraph (c)(1)(ii)(A) of this 
section with nitenpyram tablets as in Sec. 520.1510(d)(1) of this 
chapter is indicated to kill adult fleas and prevent flea eggs from 
hatching.
    (iii) Limitations. For use in dogs and puppies 4 weeks of age and 
older.

[[Page 211]]

    (2) Cats--(i) Amount. Minimum of 30 mg lufenuron per kilogram (13.6 
mg/lb) of body weight, once a month.
    (ii) Indications for use--(A) For the control of flea populations.
    (B) The concurrent use of flavored lufenuron tablets described in 
paragraph (a)(3) of this section as in paragraph (c)(2)(ii)(A) of this 
section with nitenpyram tablets as in Sec. 520.1510(d)(2) of this 
chapter is indicated to kill adult fleas and prevent flea eggs from 
hatching.
    (iii) Limitations. For use in cats and kittens 4 weeks of age and 
older.

[68 FR 51905, Aug. 29, 2003]



Sec. 520.1289  Lufenuron suspension.

    (a) Specifications. Each individual dose pack contains either 135 or 
270 milligrams of lufenuron.
    (b) Sponsor. See No. 058198 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in cats--(1) Amount. Minimum of 13.6 
milligrams per pound of body weight (30 milligrams per kilogram). 
Recommended dose of 135 milligrams for up to 10 pounds of body weight or 
270 milligrams for 11 to 20 pounds. Cats over 20 pounds are provided the 
appropriate combination of packs.
    (2) Indications for use. For control of flea populations.
    (3) Limitations. For oral use in cats 6 weeks of age or older, once 
a month, mixed with food. Administer in conjunction with a full meal to 
ensure adequate absorption. Treat all cats in the household to ensure 
maximum benefits. Because the drug has no affect on adult fleas, the 
concurrent use of insecticides that kill adults may be necessary 
depending on the severity of the infestation.

[60 FR 20402, Apr. 26, 1995, as amended at 62 FR 8371, Feb. 25, 1997]



Sec. 520.1310  Marbofloxacin.

    (a) Specifications. Each tablet contains 25, 50, 100, or 200 
milligrams (mg) marbofloxacin.
    (b) Sponsor. See Nos. 026637 and 054771 in Sec. 510.600(c) of this 
chapter.
    (c) [Reserved]
    (d) Conditions of use--(1) Amount. 1.25 mg per pound (/lb) of body 
weight once daily, but may be increased to 2.5 mg/lb of body weight once 
daily.
    (2) Indications for use. For the treatment of infections in dogs and 
cats associated with bacteria susceptible to marbofloxacin.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian. Federal law prohibits the extralabel 
use of this drug in food-producing animals.

[64 FR 39919, July 23, 1999, as amended at 66 FR 46369, Sept. 5, 2001; 
78 FR 28823, May 20, 2014; 85 FR 45307, July 28, 2020]



Sec. 520.1315  Maropitant.

    (a) Specifications. Each tablet contains 16, 24, 60, or 160 
milligrams (mg) maropitant as maropitant citrate.
    (b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in dogs--(1) Indications for use and amount. 
(i) For prevention of acute vomiting in dogs 2 to 7 months of age, 
administer a minimum dose of 2.0 mg per kilogram (/kg) body weight once 
daily for up to 5 consecutive days.
    (ii) For prevention of acute vomiting in dogs 7 months of age and 
older, administer a minimum dose of 2.0 mg/kg body weight once daily 
until resolution of acute vomiting.
    (iii) For prevention of vomiting due to motion sickness in dogs 4 
months of age and older, administer a minimum of 8.0 mg/kg body weight 
once daily for up to 2 consecutive days.
    (2) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[72 FR 9243, Mar. 1, 2007, as amended at 78 FR 28823, May 20, 2014; 80 
FR 53459, Sept. 4, 2015]



Sec. 520.1320  Mebendazole.

    (a) Specifications. (1) Each gram of powder contains either 40 or 
166.7 milligrams of mebendazole.
    (2) Each gram of paste contains 200 milligrams of mebendazole.
    (3) Each milliliter of suspension contains 33.3 milligrams of 
mebendazole.
    (b) Sponsor. See No. 000061 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use--(1) Horses--(i) Amount. 1 gram of mebendazole 
per 250 pounds of body weight per dose, as an oral powder, paste or 
suspension.

[[Page 212]]

    (ii) Indications for use. For treatment of infections caused by 
large roundworms (Parascaris equorum); large strongyles (Strongylus 
edentatus, S. equinus, S. vulgaris); small strongyles; and mature and 
immature (4th larval stage) pinworms (Oxyuris equi).
    (iii) Limitations. The drug is compatible with carbon disulfide. Do 
not use in horses intended for human consumption. Federal law restricts 
this drug to use by or on the order of a licensed veterinarian.
    (2) Dogs--(i) Amount. Administer 100 milligrams of mebendazole per 
10 pounds of body weight, once daily for 3 days, as an oral powder by 
mixing with a small quantity of food, preferably before the regular 
meal.
    (ii) Indications for use. The drug is used for treatment of 
infections of roundworms (Toxocara canis), hookworms (Ancylostoma 
caninum, Uncinaria stenocephala), whipworms (Trichuris vulpis), and 
tapeworms (Taenia pisiformis).
    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

[78 FR 28823, May 20, 2014]



Sec. 520.1326  Mebendazole and trichlorfon oral dosage forms.



Sec. 520.1326a  Mebendazole and trichlorfon powder.

    (a) Specifications. Each gram of powder contains 83.3 milligrams of 
mebendazole and 375.0 milligrams of trichlorofon.
    (b) Sponsor. See No. 000061 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in horses--(1) Amount. 8.8 milligrams of 
mebendazole and 40 milligrams of trichlorofon per kilogram of body 
weight.
    (2) Indications for use. It is used in horses for the treatment of 
infections of bots (Gastrophilus intestinalis and G. nasalis), large 
roundworms (Parascaris equorum), large strongyles (Strongylus edentatus, 
S. equinus, S. vulgaris), small strongyles, and pinworms (Oxyuris equi.)
    (3) Limitations. Do not use in horses intended for human 
consumption. Federal law restricts this drug to use by or on the order 
of a licensed veterinarian.

[45 FR 10759, Feb. 19, 1980, as amended at 46 FR 52330, Oct. 27, 1981. 
Redesignated at 51 FR 13212, Apr. 18, 1986, as amended at 62 FR 61625, 
Nov. 19, 1997; 78 FR 28824, May 20, 2014]



Sec. 520.1326b  Mebendazole and trichlorfon paste.

    (a) Specifications. Each gram of paste contains 100 milligrams of 
mebendazole and 454 milligrams of trichlorfon.
    (b) Sponsor. See No. 000061 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in horses--(1) Amount. 8.8 milligrams of 
mebendazole and 40 milligrams of trichlorfon per kilogram of body 
weight.
    (2) Indications for use. It is used in horses for treatment of 
infections of bots (Gastrophilus intestinalis and G. nasalis), large 
roundworms (Parascaris equorum), large strongyles (Strongylus edentatus, 
S. equinus, S. vulgaris), small strongyles, and pinworms (Oxyuris equi).
    (3) Limitations. Do not administer more than once every 30 days. Do 
not treat sick or debilitated animals, foals under 4 months of age, or 
mares in the last month of pregnancy. Trichlorfon is a cholinesterase 
inhibitor. Do not administer simultaneously or within a few days before 
or after treatment with, or exposure to, cholinesterase-inhibiting 
drugs, pesticides, or chemicals. Do not administer intravenous 
anesthetics, especially muscle relaxants, concurrently. Not for use in 
horses intended for food. Consult your veterinarian for assistance in 
the diagnosis, treatment, and control of parasitism.

[51 FR 13212, Apr. 18, 1986, as amended at 62 FR 61625, Nov. 19, 1997; 
78 FR 28824, May 20, 2014]



Sec. 520.1330  Meclofenamic acid granules.

    (a) Specifications. Each gram of granules contains 5 milligrams (5 
percent) meclofenamic acid.
    (b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in horses--(1) Amount. Administer 1 milligram 
per pound of body weight (1 gram per 1000 pounds) once daily for 5 to 7 
days by addition to the daily grain ration.

[[Page 213]]

    (2) Indications for use. For the treatment of acute or chronic 
inflammatory diseases involving the musculoskeletal system.
    (3) Limitations. Do not use in horses intended for human 
consumption. Federal law restricts this drug to use by or on the order 
of a licensed veterinarian.

[78 FR 28824, May 20, 2014]



Sec. 520.1331  Meclofenamic acid tablets.

    (a) Specifications. Each tablet contains either 10 or 20 milligrams 
of meclofenamic acid.
    (b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in dogs--(1) Amount. 1.1 milligrams per 
kilogram (0.5 milligram per pound) daily for 5 to 7 days.
    (2) Indications for use. For the relief of signs and symptoms of 
chronic inflammatory disease involving the musculoskeletal system.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[50 FR 43385, Oct. 25, 1985, as amended at 53 FR 23390, June 22, 1988; 
78 FR 28824, May 20, 2014]



Sec. 520.1341  Megestrol.

    (a) Specifications. Each tablet contains 5 or 20 milligrams of 
megestrol acetate.
    (b) Sponsor. See No. 000061 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in dogs--(1) Amount. Administer orally, 
intact, or crushed and mixed with food as follows:
    (i) For the postponement of estrus by proestrus treatment: 1 
milligram per pound of body weight per day for 8 days.
    (ii) For the postponement of estrus by anestrus treatment: 0.25 
milligram per pound of body weight per day for 32 days.
    (iii) For alleviation of false pregnancy: 1 milligram per pound of 
body weight per day for 8 days.
    (2) Indications for use. For the postponement of estrus and the 
alleviation of false pregnancy in female dogs.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[40 FR 13838, Mar. 27, 1975, as amended at 52 FR 7832, Mar. 13, 1987; 78 
FR 28824, May 20, 2014]



Sec. 520.1367  Meloxicam.

    (a) Specifications--(1) Each milliliter of suspension contains 0.5 
milligrams (mg) meloxicam.
    (2) Each milliliter of suspension contains 1.5 mg meloxicam.
    (b) Sponsors. See sponsors in Sec. 510.600(c) of this chapter for 
uses as in paragraph (c) of this section:
    (1) No. 000010 for use of the products described in paragraph (a) of 
this section; and
    (2) Nos. 013744 and 055529 for use of the product described in 
paragraph (a)(2) of this section.
    (c) Conditions of use in dogs--(1) Amount. Administer orally as a 
single dose at 0.09 mg per pound (mg/lb) body weight (0.2 mg per 
kilogram (mg/kg)) on the first day of treatment. For all treatment after 
day 1, administer 0.045 mg/lb (0.1 mg/kg) body weight once daily.
    (2) Indications for use. For the control of pain and inflammation 
associated with osteoarthritis.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[68 FR 42968, July 21, 2003, as amended at 69 FR 69523, Nov. 30, 2004. 
Redesignated and amended at 78 FR 57058, Sept. 17, 2013; 80 FR 53459, 
Sept. 4, 2015]



Sec. 520.1372  Methimazole.

    (a) Specifications. Each tablet contains 2.5 or 5 milligrams (mg) 
methimazole.
    (b) Sponsor. See No. 043264 in Sec. 510.600 of this chapter.
    (c) Conditions of use in cats--(1) Amount. The starting dose is 2.5 
mg every 12 hours. Following 3 weeks of treatment, the dose should be 
titrated to effect based on individual serum total T4 levels and 
clinical response.
    (2) Indications for use. For the treatment of hyperthyroidism.

[[Page 214]]

    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[74 FR 27707, June 11, 2009]



Sec. 520.1380  Methocarbamol.

    (a) Specifications. Each tablet contains 500 milligrams (mg) of 
methocarbamol.
    (b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in dogs and cats--(1) Amount. Administer 60 mg 
per pound of body weight in two or three equally divided doses, followed 
each following day by 30 to 60 mg per pound of body weight, usually not 
to exceed 14 to 21 days.
    (2) Indications for use. As an adjunct to therapy for acute 
inflammatory and traumatic conditions of the skeletal muscles in order 
to reduce muscular spasms.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[78 FR 28824, May 20, 2014]



Sec. 520.1408  Methylprednisolone.

    (a) Specifications. Each tablet contains 1, 2, or 4 milligrams (mg) 
of methylprednisolone.
    (b) Sponsors. See sponsors in Sec. 510.600(c) of this chapter.
    (1) No. 069043 for use of 1- and 2-mg tablets.
    (2) No. 054771 for use of 1- and 4-mg tablets.
    (c) Conditions of use in dogs and cats--(1) Amount. 5 to 15 pounds 
(lbs): 2 mg; 15 to 40 lbs: 2 to 4 mg; 40 to 80 lbs: 4 to 8 mg. 
Administer total daily dose orally in equally divided doses 6 to 10 
hours apart until response is noted or 7 days have elapsed.
    (2) Indications for use. As an anti-inflammatory agent.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[78 FR 28824, May 20, 2014, as amended at 83 FR 48946, Sept. 28, 2018]



Sec. 520.1409  Methylprednisolone and aspirin.

    (a) Specifications. Each tablet contains 0.5 milligram of 
methylprednisolone and 300 milligrams of aspirin.
    (b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in dogs--(1) Amount. Under 15 pounds, \1/4\ to 
1 tablet daily; 15 to 60 pounds, 1 to 2 tablets daily; 60 pounds and 
over, 2 tablets daily. Administer total daily dose in divided doses 6 to 
10 hours apart, with a light feeding. When response is attained, dosage 
should be gradually reduced until maintenance level is achieved.
    (2) Indications for use. As an anti-inflammatory and analgesic 
agent.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[48 FR 21566, May 13, 1983, as amended at 78 FR 28824, May 20, 2014]



Sec. 520.1422  Metoserpate hydrochloride.

    (a) Chemical name. Methyl-o-methyl-18-epireserpate hydrochloride.
    (b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
    (c) Related tolerances. See Sec. 556.410 of this chapter.
    (d) Conditions of use. It is used in drinking water for replacement 
chickens as follows:
    (1) Amount. 568.5 milligrams per gallon (0.015 percent).
    (i) Indications for use. As a tranquilizer for flock treatment of 
chickens prior to handling.
    (ii) Limitations. To be used one time as a treatment for replacement 
chickens up to 16 weeks of age; usual drinking water should be withheld 
prior to treatment to provide adequate consumption of medicated drinking 
water; not for use in laying chickens; chickens slaughtered within 72 
hours following treatment must not be used for food.
    (2) Amount. 2 to 4 milligrams per 2.2 pounds of body weight.
    (i) Indications for use. As an aid in control of hysteria.
    (ii) Limitations. To be used as a treatment for replacement chickens 
up to 16 weeks of age; usual drinking water should be withheld prior to 
treatment to provide adequate consumption of medicated drinking water; 
the drug should be administered at a dosage level of 4 milligrams per 
2.2 pounds of

[[Page 215]]

body weight followed by 2 treatments at 4-day intervals of 2 milligrams 
per 2.2 pounds of body weight; not for use in laying chickens; chickens 
slaughtered within 72 hours following treatment must not be used for 
food.

[40 FR 13838, Mar. 27, 1975, as amended at 76 FR 17337, Mar. 29, 2011; 
78 FR 28824, May 20, 2014]



Sec. 520.1430  Mibolerone.

    (a) Specifications. Each milliliter contains 100 micrograms of 
mibolerone.
    (b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in dogs--(1) Amount. 30 micrograms for animals 
weighing 1 to 25 pounds; 60 micrograms for animals weighing 26 to 50 
pounds; 120 micrograms for animals weighing 51 to 100 pounds; 180 
micrograms for animals weighing over 100 pounds, German Shepherds, or 
German Shepherd mix. Administer daily, orally or in a small amount of 
food, at least 30 days before expected initiation of heat, and continue 
daily as long as desired, but not for more than 24 months.
    (2) Indications for use. For the prevention of estrus (heat) in 
adult female dogs not intended primarily for breeding purposes.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[43 FR 15625, Apr. 14, 1978, as amended at 78 FR 28824, May 20, 2014]



Sec. 520.1441  Milbemycin.

    (a) Specifications. Each flavored tablet contains 2.3, 5.75, 11.5, 
or 23.0 milligrams (mg) of milbemycin oxime.
    (b) Sponsors. See Nos. 013744 and 058198 in Sec. 510.600(c) of this 
chapter.
    (c) Conditions of use--(1) Dogs--(i) Amount. For hookworm, 
roundworm, and whipworm, administer 0.23 mg per pound (mg/lb) of body 
weight (0.5 mg per kilogram (mg/kg)). For heartworm, administer 0.05 mg/
lb of body weight (0.1 mg/kg). Administer once a month.
    (ii) Indications for use. For prevention of heartworm disease caused 
by Dirofilaria immitis, control of hookworm infections caused by 
Ancylostoma caninum, and removal and control of adult roundworm 
infections caused by Toxocara canis and Toxascaris leonina and whipworm 
infections caused by Trichuris vulpis in dogs and puppies 4 weeks of age 
or greater and 2 pounds body weight or greater.
    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.
    (2) Cats--(i) Amount. Administer 0.91 mg/lb of body weight (2.0 mg/
kg) once a month.
    (ii) Indications for use. For prevention of heartworm disease caused 
by Dirofilaria immitis and the removal of adult Toxocara cati 
(roundworm) and Ancylostoma tubaeforme (hookworm) infections in cats 6 
weeks of age or greater and 1.5 pounds body weight or greater.
    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

[84 FR 12494, Apr. 2, 2019]



Sec. 520.1443  Milbemycin oxime and lufenuron.

    (a) Specifications. (1) Tablets containing: 2.3 milligrams (mg) 
milbemycin oxime and 46 mg lufenuron, 5.75 mg milbemycin oxime and 115 
mg lufenuron, 11.5 mg milbemycin oxime and 230 mg lufenuron, or 23 mg 
milbemycin oxime and 460 mg lufenuron.
    (2) Flavored tablets containing: 2.3 mg milbemycin oxime and 46 mg 
lufenuron, 5.75 mg milbemycin oxime and 115 mg lufenuron, 11.5 mg 
milbemycin oxime and 230 mg lufenuron, or 23 mg milbemycin oxime and 460 
mg lufenuron.
    (b) Sponsor. See No. 000061 in Sec. 510.600(c) of this chapter.
    (c) [Reserved]
    (d) Conditions of use--(1) Dogs--(i) Amount. 0.5 mg milbemycin oxime 
and 10 mg lufenuron per kilogram of body weight, once a month.
    (ii) Indications for use. (A) For use in dogs and puppies for the 
prevention of heartworm disease caused by Dirofilaria immitis, for 
prevention and control of flea populations, for control of adult 
Ancylostoma caninum (hookworm), and for removal and control of adult 
Toxocara canis, Toxascaris leonina (roundworm), and Trichuris vulpis 
(whipworm) infections.

[[Page 216]]

    (B) The concurrent use of flavored milbemycin oxime and lufenuron 
tablets described in paragraph (a)(2) of this section as in paragraph 
(d)(1)(ii)(A) of this section with nitenpyram tablets as in Sec. 
520.1510(d)(1) of this chapter is indicated to kill adult fleas and 
prevent flea eggs from hatching.
    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.
    (2) [Reserved]

[62 FR 28629, May 27, 1997, as amended at 63 FR 41190, Aug. 3, 1998; 68 
FR 51905, Aug. 29, 2003. Redesignated at 77 FR 47512, Aug. 9, 2012, as 
amended at 80 FR 18776, Apr. 8, 2015; 86 FR 13184, Mar. 8, 2021]



Sec. 520.1445  Milbemycin oxime and praziquantel.

    (a) Specifications. Each chewable tablet contains:
    (1) 2.3 milligrams (mg) milbemycin oxime and 22.8 mg praziquantel;
    (2) 5.75 mg milbemycin oxime and 57 mg praziquantel;
    (3) 11.5 mg milbemycin oxime and 114 mg praziquantel; or
    (4) 23 mg milbemycin oxime and 228 mg praziquantel.
    (b) Sponsor. See No. 058198 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use--(1) Dogs--(i) Amount. Administer orally, once 
a month, a minimum dosage of 0.23 mg per pound (mg/lb) of body weight 
(0.5 mg per kilogram (mg/kg)) milbemycin oxime and 2.28 mg/lb of body 
weight (5 mg/kg) praziquantel.
    (ii) Indications for use. For the prevention of heartworm disease 
caused by Dirofilaria immitis and for the treatment and control of adult 
roundworm (Toxocara canis, Toxascaris leonina), adult hookworm 
(Ancylostoma caninum), adult whipworm (Trichuris vulpis), and adult 
tapeworm (Taenia pisiformis, Echinococcus multilocularis, E. granulosus, 
and Dipylidium caninum) infections in dogs and puppies 2 pounds of body 
weight or greater and 6 weeks of age and older.
    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.
    (2) [Reserved]

[77 FR 47512, Aug. 9, 2012, as amended at 82 FR 58556, Dec. 13, 2017]



Sec. 520.1447  Milbemycin oxime, lufenuron, and praziquantel tablets.

    (a) Specifications. Each tablet contains:
    (1) 2.3 milligrams (mg) milbemycin oxime, 46 mg lufenuron, and 22.8 
mg praziquantel;
    (2) 5.75 mg milbemycin oxime, 115 mg lufenuron, and 57 mg 
praziquantel;
    (3) 11.5 mg milbemycin oxime, 230 mg lufenuron, and 114 mg 
praziquantel; or
    (4) 23 mg milbemycin oxime, 460 mg lufenuron, and 228 mg 
praziquantel.
    (b) Sponsor. See No. 000061 in Sec. 510.600(c) of this chapter.
    (c) [Reserved]
    (d) Conditions of use--(1) Dogs--(i) Amount. 0.5 mg milbemycin 
oxime, 10 mg lufenuron, and 5 mg of praziquantel per kilogram of body 
weight, once a month.
    (ii) Indications for use. For the prevention of heartworm disease 
caused by Dirofilaria immitis; for the prevention and control of flea 
populations (Ctenocephalides felis); and for the treatment and control 
of adult roundworm (Toxocara canis, Toxascaris leonina), adult hookworm 
(Ancylostoma caninum), adult whipworm (Trichuris vulpis), and adult 
tapeworm (Dipylidium caninum, Taenia pisiformis, Echinococcus 
multilocularis, and E. granulosus) infections in dogs and puppies 2 
pounds of body weight or greater and 6 weeks of age and older.
    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.
    (2) [Reserved]

[77 FR 4225, Jan. 27, 2012, as amended at 80 FR 18776, Apr. 8, 2015; 83 
FR 13635, Mar. 30, 2018; 86 FR 13184, Mar. 8, 2021]



Sec. 520.1450  Morantel tartrate oral dosage forms.



Sec. 520.1450a  Morantel tartrate bolus.

    (a) Specifications. Each bolus contains 2.2 grams morantel tartrate 
equivalent to 1.3 grams of morantel base.
    (b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
    (c) Related tolerances. See Sec. 556.425 of this chapter.
    (d) Conditions of use--(1) Amount. One bolus per 500 pounds of body 
weight (4.4 milligrams per pound of body weight) as a single oral dose. 
Boluses may be

[[Page 217]]

divided in half for more accurate dosing as follows: up to 325 pounds, 
\1/2\ bolus; 326 to 600 pounds, 1 bolus; 601 to 900 pounds, 1\1/2\ 
boluses; and 901 to 1,200 pounds, 2 boluses.
    (2) Indications for use. For removal and control of mature 
gastrointestinal nematode infections of cattle including stomach worms 
(Haemonchus spp., Ostertagia spp., Trichostrongylus spp.), worms of the 
small intestine (Cooperia spp., Trichostrongylus spp., Nematodirus 
spp.), and worms of the large intestine (Oesophagostomum radiatum).
    (3) Limitations. Conditions of constant worm exposure may require 
retreatment in 2 to 4 weeks. Consult your veterinarian before 
administering to severely debilitated animals and for assistance in the 
diagnosis, treatment, and control of parasitism. Do not treat within 14 
days of slaughter.

[46 FR 50949, Oct. 16, 1981. Redesignated at 49 FR 47831, Dec. 7, 1984, 
and amended at 51 FR 9005, Mar. 17, 1986; 78 FR 28825, May 20, 2014]



Sec. 520.1450b  Morantel tartrate cartridge.

    (a) Specifications. The drug product consists of a stainless-steel 
cylinder having both ends closed with polyethylene diffusing discs and 
containing a morantel tartrate paste. The paste contains 22.7 grams of 
morantel tartrate equivalent to 13.5 grams of morantel base.
    (b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
    (c) Related tolerances. See Sec. 556.425 of this chapter.
    (d) Conditions of use--(1) Amount. Grazing cattle: Administer 1 
cartridge to each animal at the start of the grazing season.
    (2) Indications for use. For control of the adult stage of the 
following gastrointestinal nematode infections in weaned calves and 
yearling cattle weighing a minimum of 200 pounds: Ostertagia spp., 
Trichostrongylus axei, Cooperia spp., and Oesophagostomum radiatum.
    (3) Limitations. Administer orally with the dosing gun to all cattle 
that will be grazing the same pasture. Effectiveness of the drug product 
is dependent upon continuous control of the gastrointestinal parasites 
for approximately 90 days following administration. Therefore, treated 
cattle should not be moved to pastures grazed in the same grazing 
season/calendar year by untreated cattle. Do not administer to cattle 
within 106 days of slaughter. Consult your veterinarian before 
administering to severely debilitated animals and for assistance in the 
diagnosis, treatment, and control of parasitism.

[49 FR 47831, Dec. 7, 1984, as amended at 51 FR 23415, June 27, 1986; 51 
FR 41081, Nov. 13, 1986; 78 FR 28825, May 20, 2014]



Sec. 520.1450c  Morantel tartrate sustained-release trilaminate
cylinder/sheet.

    (a) Specifications. The drug product consists of a trilaminated, 
perforated, plastic sheet formed into a cylinder having plastic plugs in 
its ends. The core lamina contains 19.8 grams of morantel tartrate 
equivalent to 11.8 grams of morantel base.
    (b) Sponsor. See 054771 in Sec. 510.600(c) of this chapter.
    (c) Related tolerances. See Sec. 556.425 of this chapter.
    (d) Conditions of use--(1) Amount. Grazing cattle: Administer 1 
cartridge to each animal at the start of the grazing season.
    (2) Indications for use. For control of the adult stage of the 
following gastrointestinal nematode infections in weaned calves and 
yearling cattle weighing a minimum of 200 pounds: Ostertagia spp., 
Trichostrongylus axei, Cooperia spp., and Oesophagostomum radiatum.
    (3) Limitations. Administer orally with the dosing gun to all cattle 
that will be grazing the same pasture. Effectiveness of the drug product 
is dependent upon continuous control of the gastrointestinal parasites 
for approximately 90 days following administration. Therefore, treated 
cattle should not be moved to pastures grazed in the same grazing 
season/calendar year by untreated cattle. Do not administer to cattle 
within 102 days of slaughter. Consult your veterinarian before 
administering to severely debilitated animals and for assistance in the 
diagnosis, treatment, and control of parasitism.

[56 FR 13396, Apr. 2, 1991, as amended at 78 FR 28825, May 20, 2014]

[[Page 218]]



Sec. 520.1451  Moxidectin tablets.

    (a) Specifications. Each tablet contains 30, 68, or 136 micrograms 
of moxidectin.
    (b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use--(1) Amount. 3 micrograms per kilogram (1.36 
micrograms per pound) of body weight.
    (2) Indications for use. To prevent infection by the canine 
heartworm Dirofilaria immitis and the subsequent development of canine 
heartworm disease.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[62 FR 37713, July 15, 1997, as amended at 78 FR 28825, May 20, 2014]



Sec. 520.1452  Moxidectin gel.

    (a) Specifications. Each milliliter of gel contains 20 milligrams (2 
percent) moxidectin.
    (b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
    (c) Special considerations. See Sec. 500.25 of this chapter.
    (d) Conditions of use in horses and ponies--(1) Amount. 0.4 
milligram moxidectin per kilogram (2.2 pounds) of body weight.
    (2) Indications for use. For the treatment and control of large 
strongyles: Strongylus vulgaris (adults and L4/L5 arterial stages), S. 
edentatus (adult and tissue stages), Triodontophorus brevicauda 
(adults), and T. serratus (adults); small strongyles (adults): 
Cyathostomum spp., including C. catinatum and C. pateratum; 
Cylicocyclus. spp., including C. insigne, C. leptostomum, C. nassatus, 
and C. radiatus; Cyliocostephanus spp., including C. calicatus, C. 
goldi, C. longibursatus, and C. minutus; Coronocyclus spp., including C. 
coronatus, C. labiatus, and C. labratus; Gyalocephalus capitatus; and 
Petrovinema poculatus; small strongyles: undifferentiated lumenal 
larvae; encysted cyathostomes (late L3 and L4 mucosal cyathostome 
larvae); ascarids: Parascaris equorum (adults and L4 larval stages); 
pinworms: Oxyuris equi (adults and L4 larval stages); hairworms: 
Trichostrongylus axei (adults); large-mouth stomach worms: Habronema 
muscae (adults); and horse stomach bots: Gasterophilus intestinalis (2nd 
and 3rd instars) and G. nasalis (3rd instars). One dose also suppresses 
strongyle egg production for 84 days.
    (3) Limitations. Do not use in horses intended for human 
consumption.

[62 FR 42902, Aug. 11, 1997, as amended at 64 FR 66105, Nov. 24, 1999; 
68 FR 51445, Aug. 27, 2003; 69 FR 24959, May 5, 2004; 70 FR 75017, Dec. 
19, 2005; 78 FR 28825, May 20, 2014]



Sec. 520.1453  Moxidectin and praziquantel gel.

    (a) Specifications. Each milliliter of gel contains 20 milligrams 
(mg) (2.0 percent) moxidectin and 125 mg (12.5 percent) praziquantel.
    (b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
    (c) Special considerations. See Sec. 500.25 of this chapter.
    (d) Conditions of use in horses and ponies--(1) Amount. Administer 
by mouth as a single dose: 0.4 mg moxidectin per kilogram and 2.5 mg 
praziquantel per kilogram (2.2 pounds) body weight.
    (2) Indications for use. For the treatment and control of large 
strongyles: Strongylus vulgaris (adults and L4/L5 arterial stages), S. 
edentatus (adult and tissue stages), Triodontophorus brevicauda 
(adults), and T. serratus (adults); small strongyles (adults): 
(Cyathostomum spp., including C. catinatum and C. pateratum; 
Cylicocyclus spp., including C. insigne, C. leptostomum, C. nassatus, 
and C. radiatus; Cylicostephanus spp., including C. calicatus, C. goldi, 
C. longibursatus, and C. minutus; Coronocyclus spp., including C. 
coronatus, C. labiatus, and C. labratus; Gyalocephalus capitatus; and 
Petrovinema poculatus; small strongyles: undifferentiated lumenal 
larvae; encysted cyathostomes (late L3 and L4 mucosal cyathostome 
larvae); ascarids: Parascaris equorum (adults and L4 larval stages); 
pinworms: Oxyuris equi (adults and L4 larval stages); hairworms: 
Trichostrongylus axei (adults); large-mouth stomach worms: Habronema 
muscae (adults); horse stomach bots: Gasterophilus intestinalis (2nd and 
3rd instars) and G. nasalis (3rd instars); and tapeworms: Anoplocephala

[[Page 219]]

perfoliata (adults). One dose also suppresses strongyle egg production 
for 84 days.
    (3) Limitations. Do not use in horses intended for human 
consumption.

[68 FR 51446, Aug. 27, 2003, as amended at 69 FR 21956, Apr. 23, 2004; 
70 FR 75017, Dec. 19, 2005; 78 FR 28825, May 20, 2014]



Sec. 520.1454  Moxidectin solution.

    (a) Specifications. Each milliliter (mL) of solution contains 1 
milligram (mg) moxidectin.
    (b) Sponsor. See No. 058198 in Sec. 510.600(c) of this chapter.
    (c) Related tolerances. See Sec. 556.426 of this chapter.
    (d) Special considerations. See Sec. 500.25 of this chapter.
    (e) Conditions of use in sheep--(1) Amount. Administer 1 mL per 11 
pounds body weight (1 mL per 5 kilograms) by mouth.
    (2) Indications for use. For the treatment and control of the adult 
and L4 larval stages of Haemonchus contortus, Teladorsagia circumcincta, 
T. trifurcata, Trichostrongylus axei, T. colubriformis, T. vitrinus, 
Cooperia curticei, C. oncophora, Oesophagostomum columbianum, O. 
venulosum, Nematodirus battus, N. filicollis, and N. spathiger.
    (3) Limitations. Sheep must not be slaughtered for human consumption 
within 7 days of treatment. Because a withholding time in milk has not 
been established for this product, do not use in female sheep providing 
milk for human consumption.

[70 FR 76163, Dec. 23, 2005, as amended at 76 FR 48714, Aug. 9, 2011; 82 
FR 21690, May 10, 2017; 86 FR 14818, Mar. 19, 2021]



Sec. 520.1468  Naproxen.

    (a) Specifications. Each gram of granules contains 500 milligrams 
(mg) (50 percent) naproxen.
    (b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in horses--(1) Amount. 10 mg per kilogram of 
body weight twice daily top dressed on feed for up to 14 consecutive 
days.
    (2) Indications for use. For the relief of inflammation and 
associated pain and lameness exhibited with arthritis, as well as 
myositis and other soft tissue diseases of the musculoskeletal system.
    (3) Limitations. Do not use in horses intended for human 
consumption. Federal law restricts this drug to use by or on the order 
of a licensed veterinarian.

[78 FR 28825, May 20, 2014]



Sec. 520.1484  Neomycin.

    (a) Specifications. (1) Each ounce of powder contains 20.3 grams (g) 
neomycin sulfate (equivalent to 14.2 g neomycin base).
    (2) Each milliliter of solution contains 200 milligrams (mg) 
neomycin sulfate (equivalent to 140 mg neomycin base).
    (b) Sponsors. See sponsors in Sec. 510.600(c) of this chapter for 
use as in paragraph (e) of this section.
    (1) Nos. 054771 and 054925 for use of product described in paragraph 
(a)(1) as in paragraph (e)(1) of this section.
    (2) Nos. 016592, 054771, 058005, and 061133 for use of product 
described in paragraph (a)(1) as in paragraphs (e)(1) and (e)(2) of this 
section.
    (3) Nos. 016592, 054771, 054925, and 058005 for use of product 
described in paragraph (a)(2) as in paragraph (e)(1) of this section.
    (c) Related tolerances. See Sec. 556.430 of this chapter.
    (d) Special labeling considerations. Labeling shall bear the 
following warning statements: ``A withdrawal period has not been 
established for use in preruminating calves. Do not use in calves to be 
processed for veal. Use of more than one product containing neomycin or 
failure to follow withdrawal times may result in illegal drug 
residues.''
    (e) Conditions of use--(1) Cattle, swine, sheep, and goats--(i) 
Amount. 10 mg per pound (/lb) of body weight per day (22 mg per kilogram 
(/kg)) in divided doses for a maximum of 14 days.
    (ii) Indications for use. For the treatment and control of 
colibacillosis (bacterial enteritis) caused by Escherichia coli 
susceptible to neomycin sulfate.
    (iii) Limitations. Discontinue treatment prior to slaughter as 
follows: Cattle, 1 day; sheep, 2 days; swine and goats, 3 days. Federal 
law restricts this drug to use by or on the order of a licensed 
veterinarian.
    (2) Turkeys--(i) Amount. 10 mg/lb of body weight per day (22 mg/kg) 
for 5 days.

[[Page 220]]

    (ii) Indications for use. For the control of mortality associated 
with E. coli susceptible to neomycin sulfate in growing turkeys.
    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

[71 FR 56866, Sept. 28, 2006, as amended at 71 FR 68738, Nov. 28, 2006; 
78 FR 17596, Mar. 22, 2013; 78 FR 28825, May 20, 2014; 81 FR 22523, Apr. 
18, 2016; 81 FR 94989, Dec. 27, 2016; 84 FR 8973, Mar. 13, 2019]



Sec. 520.1510  Nitenpyram.

    (a) Specifications. Each tablet contains 11.4 or 57 milligrams (mg) 
nitenpyram.
    (b) Sponsors. See sponsor numbers in Sec. 510.600(c) of this 
chapter:
    (1) No. 058198 for use as in paragraphs (d)(1)(i)(A), (d)(1)(ii)(A), 
and (d)(2) of this section.
    (2) No. 000061 for use as in paragraphs (d)(1)(i)(B) and 
(d)(1)(ii)(B) of this section.
    (c) Special considerations. The concurrent use of nitenpyram tablets 
and flavored milbemycin/lufenuron tablets as in paragraph (d)(1)(ii)(B) 
of this section shall be by or on the order of a licensed veterinarian.
    (d) Conditions of use--(1) Dogs--(i) Amount. (A) One 11.4-mg tablet 
for dogs weighing less than 25 pounds (lb) or one 57-mg tablet for dogs 
weighing more than 25 lb, as needed, for use as in paragraph 
(d)(1)(ii)(A) of this section.
    (B) One 11.4-mg tablet for dogs weighing less than 25 lb or one 57 
mg tablet for dogs weighing more than 25 lbs, once or twice weekly, for 
use as in paragraph (d)(1)(ii)(B) of this section.
    (ii) Indications for use. (A) For the treatment of flea infestations 
on dogs and puppies 4 weeks of age and older and 2 lbs of body weight or 
greater.
    (B) The concurrent use of nitenpyram tablets as in paragraph 
(d)(1)(i)(B) of this section with either flavored lufenuron tablets as 
in Sec. 520.1288(c)(1) of this chapter or flavored milbemycin and 
lufenuron tablets as in Sec. 520.1443(d)(1) is indicated to kill adult 
fleas and prevent flea eggs from hatching.
    (2) Cats--(i) Amount. (A) One 11.4-mg tablet, as needed, for use as 
in paragraph (d)(2)(ii)(A) of this section.
    (B) One 11.4-mg tablet, once or twice weekly, for use as in 
paragraph (d)(2)(ii)(B) of this section.
    (ii) Indications for use. (A) For the treatment of flea infestations 
on cats and kittens 4 weeks of age and older and 2 lbs of body weight or 
greater.
    (B) The concurrent use of nitenpyram tablets as in paragraph 
(d)(2)(i)(B) of this section with flavored lufenuron tablets as in Sec. 
520.1288(c)(2) of this chapter is indicated to kill adult fleas and 
prevent flea eggs from hatching.

[68 FR 51906, Aug. 29, 2003, as amended at 80 FR 18776, Apr. 8, 2015; 86 
FR 13184, Mar. 8, 2021]



Sec. 520.1604  Oclacitinib.

    (a) Specifications. Each tablet contains 3.6, 5.4, or 16 milligrams 
(mg) of oclacitinib as oclacitinib maleate.
    (b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use--(1) Amount. Administer orally 0.18 to 0.27 
mg/per pound of body weight (0.4 to 0.6 mg/kg body weight) twice daily 
for up to 14 days; then administered once daily for maintenance therapy.
    (2) Indications for use. For control of pruritus associated with 
allergic dermatitis and control of atopic dermatitis in dogs at least 12 
months of age.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[78 FR 42007, July 15, 2013]



Sec. 520.1615  Omeprazole.

    (a) Specifications. Each gram of paste contains 0.37 gram 
omeprazole.
    (b) Sponsor. See No. 000010 in Sec. 510.600(c) of this chapter.
    (c) Special considerations. When labeled for use as in paragraph 
(d)(2)(i) of this section, product labeling shall bear: ``Federal law 
restricts this drug to use by or on the order of a licensed 
veterinarian.''
    (d) Conditions of use in horses--(1) Amount. (i) For treatment of 
gastric ulcers, 1.8 milligrams per pound (mg/lb) of body weight (4 
milligrams per kilogram (mg/kg)) once daily for 4 weeks. For prevention 
of recurrence of gastric ulcers, 0.9 mg/lb of body weight (2 mg/kg) once 
daily for at least an additional 4 weeks.

[[Page 221]]

    (ii) For prevention of gastric ulcers using the premarked syringe, 
one dose per day for 8 or 28 days. Each dose delivers at least 1 mg/kg 
of body weight. Horses over 1,200 lb body weight should receive two 
doses per day.
    (2) Indications for use. (i) For treatment and prevention of 
recurrence of gastric ulcers in horses and foals 4 weeks of age and 
older.
    (ii) For prevention of gastric ulcers in horses.
    (3) Limitations. Do not use in horses intended for human 
consumption.

[69 FR 13220, Mar. 22, 2004, as amended at 71 FR 59374, Oct. 10, 2006; 
84 FR 39183, Aug. 9, 2019]



Sec. 520.1616  Orbifloxacin tablets.

    (a) Specifications. Each tablet contains 5.7, 22.7, or 68 milligrams 
(mg) orbifloxacin.
    (b) Sponsor. See No. 000061 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in dogs and cats--(1) Amount. 2.5 to 7.5 mg 
per kilogram body weight once daily.
    (2) Indications for use. For management of diseases associated with 
bacteria susceptible to orbifloxacin.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian. Federal law prohibits the extralabel 
use of this drug in food producing animals.

[71 FR 14643, Mar. 23, 2006, as amended at 75 FR 26646, May 12, 2010]



Sec. 520.1618  Orbifloxacin suspension.

    (a) Specifications. Each milliliter of suspension contains 30 
milligrams (mg) orbifloxacin.
    (b) Sponsor. See No. 000061 in 510.600(c) of this chapter.
    (c) Special considerations. Federal law restricts this drug to use 
by or on the order of a licensed veterinarian. Federal law prohibits the 
extralabel use of this drug in food-producing animals.
    (d) Conditions of use--(1) Dogs--(i) Amount. 1.1 to 3.4 mg/lb (2.5 
to 7.5 mg/kg) of body weight once daily.
    (ii) Indications for use. For the treatment of urinary tract 
infections (cystitis) in dogs caused by susceptible strains of 
Staphylococcus pseudintermedius, Proteus mirabilis, Escherichia coli, 
and Enterococcus faecalis and skin and soft tissue infections (wounds 
and abscesses) in dogs caused by susceptible strains of Staphylococcus 
pseudintermedius, Staphylococcus aureus, coagulase-positive 
staphylococci, Pasteurella multocida, Proteus mirabilis, Pseudomonas 
spp., Klebsiella pneumoniae, E. coli, Enterobacter spp., Citrobacter 
spp., E. faecalis, [beta]-hemolytic streptococci (Group G), and 
Streptococcus equisimilis.
    (2) Cats--(i) Amount. 3.4 mg/lb (7.5 mg/kg) of body weight once 
daily.
    (ii) Indications for use. For the treatment of skin infections 
(wounds and abscesses) in cats caused by susceptible strains of S. 
aureus, E. coli, and P. multocida.

[75 FR 26646, May 12, 2010]



Sec. 520.1628  Oxfendazole powder and pellets.

    (a) Specifications--(1) Powder for suspension. Each gram of powder 
contains 7.57 percent oxfendazole.
    (2) Pellets. Each gram of pellets contains 6.49 percent oxfendazole.
    (b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use--(1) Amount. 10 milligrams per kilogram of 
body weight.
    (2) Indications for use. The drug is used in horses for removal of 
the following gastrointestinal worms: Large roundworms (Parascaris 
equorum), mature and immature pinworms (Oxyuris equi), large strongyles 
(Strongylus edentatus, Strongylus vulgaris, and Strongylus equinus), and 
small strongyles.
    (3) Limitations--(i) Powder for suspension. For gravity 
administration via stomach tube or for positive administration via 
stomach tube and dose syringe. Discard unused portions of suspension 
after 24 hours. Mix drug according to directions prior to use. 
Administer drug with caution to sick or debilitated horses. Not for use 
in horses intended for food. Federal law restricts this drug to use by 
or on the order of a licensed veterinarian.
    (ii) Pellets. The drug is given by sprinkling on the grain portion 
of the ration. Withholding feed or water prior to administration is not 
necessary. Administer drug with caution to sick or debilitated horses. 
Not for use in horses intended for food. Consult your

[[Page 222]]

veterinarian for assistance in the diagnosis, treatment, and control of 
parasitism.

[44 FR 35211, June 19, 1979, as amended at 46 FR 26301, May 12, 1981; 46 
FR 60570, Dec. 11, 1981; 49 FR 28549, July 13, 1984; 61 FR 5506, Feb. 
13, 1996; 78 FR 28825, May 20, 2014]



Sec. 520.1629  Oxfendazole paste.

    (a)(1) Specifications. Each gram of paste contains 0.375 gram 
oxfendazole (37.5 percent).
    (2) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
    (3) Conditions of use--(i) Amount. 10 milligrams per kilogram (2.2 
pounds) of body weight.
    (ii) Indications for use. The drug is used in horses for removal of 
the following gastrointestinal worms: Large roundworms (Parascaris 
equorum), mature and 4th stage larvae pinworms (Oxyuris equi), large 
strongyles (Strongylus edentatus, S. vulgaris, and S. equinus), and 
small strongyles.
    (iii) Limitations. Horses maintained on premises where reinfection 
is likely to occur should be retreated in 6 to 8 weeks. Withholding feed 
or water prior to use is unnecessary. Administer drug with caution to 
sick or debilitated horses. Not for use in horses intended for food. 
Consult your veterinarian for assistance in the diagnosis, treatment, 
and control of parasitism.
    (b)(1) Specifications. Each gram of paste contains 185 milligrams of 
oxfendazole (18.5 percent).
    (2) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
    (3) Related tolerances. See Sec. 556.495 of this chapter.
    (4) Conditions of use--(i) Amount. 4.5 milligrams per kilogram of 
body weight (2.05 milligrams per pound).
    (ii) Indications for use. The drug is used in cattle for the removal 
and control of the following worms: lungworms (Dictyocaulus viviparus--
adult, L4); stomach worms: barberpole worms (Haemonchus contortus and H. 
placei--adult), small stomach worms (Trichostrongylus axei--adult), 
brown stomach worms (Ostertagia ostertagi--adult, L4, inhibited L4); 
intestinal worms; nodular worms (Oesophagostomum radiatum--adult), 
hookworms (Bunostomum phlebotomum--adult), small intestinal worms 
(Cooperia punctata, C. oncophora, and C. mcmasteri--adult, L4); and 
tapeworms (Moniezia benedeni--adult).
    (iii) Limitations. For use in cattle only. Treatment may be repeated 
in 4 to 6 weeks. Cattle must not be slaughtered until 11 days after 
treatment. Do not use in female dairy cattle of breeding age. Consult a 
veterinarian for assistance in the diagnosis, treatment, and control of 
parasitism.

[49 FR 38250, Sept. 28, 1984, as amended at 58 FR 39443, July 23, 1993; 
61 FR 5506, Feb. 13, 1996; 78 FR 28825, May 20, 2014]



Sec. 520.1630  Oxfendazole suspension.

    (a) Specifications. Each milliliter of suspension contains:
    (1) 90.6 milligrams (mg) oxfendazole (9.06 percent).
    (2) 225.0 mg oxfendazole (22.5 percent).
    (b) Sponsor. See Nos. 000010 and 054771 in Sec. 510.600(c) of this 
chapter.
    (c) Related tolerances. See Sec. 556.495 of this chapter.
    (d) Special considerations. See Sec. 500.25 of this chapter. If 
labeled for administration by stomach tube: Federal law restricts this 
drug to use by or on the order of a licensed veterinarian.
    (e) Conditions of use--(1) Horses. Use the product described in 
paragraph (a)(1) of this section as follows:
    (i) Amount. 10 mg per kilogram (/kg) of body weight by stomach tube 
or dose syringe. Horses maintained on premises where reinfection is 
likely to occur should be retreated in 6 to 8 weeks.
    (ii) Indications for use. For removal of large roundworms 
(Parascaris equorum), mature and 4th stage larvae pinworms (Oxyuris 
equi), large strongyles (Strongylus edentatus, S. vulgaris, and S. 
equinus), and small strongyles.
    (iii) Limitations. Withholding feed or water prior to use is 
unnecessary. Administer drug with caution to sick or debilitated horses. 
Do not use in horses intended for human consumption.
    (2) Cattle. Use the products described in paragraphs (a)(1) and 
(a)(2) of this section as follows:
    (i) Amount. 4.5 mg/kg of body weight by dose syringe. Treatment may 
be repeated in 4 to 6 weeks.
    (ii) Indications for use. For the removal and control of: lungworms 
(Dictyocaulus viviparus--adult, L4); stomach worms: barberpole worms

[[Page 223]]

(Haemonchus contortus and H. placei--adult), small stomach worms 
(Trichostrongylus axei--adult), brown stomach worms (Ostertagia 
ostertagi--adult, L4, inhibited L4); intestinal worms; nodular worms 
(Oesophagostomum radiatum--adult), hookworms (Bunostomum phlebotomum--
adult), small intestinal worms (Cooperia punctata, C. oncophora, and C. 
surnabada--adult, L4), and tapeworms (Moniezia benedeni--adult).
    (iii) Limitations. Cattle must not be slaughtered until 7 days after 
treatment. Because a withdrawal time in milk has not been established, 
do not use in female dairy cattle of breeding age.

[55 FR 46943, Nov. 8, 1990, as amended at 56 FR 8710, Mar. 1, 1991; 61 
FR 5506, Feb. 13, 1996; 72 FR 10596, Mar. 9, 2007; 73 FR 45610, Aug. 6, 
2008; 75 FR 10166, Mar. 5, 2010; 78 FR 28825, May 20, 2014]



Sec. 520.1631  Oxfendazole and trichlorfon paste.

    (a) Specifications. Each gram of paste contains 28.5 milligrams 
oxfendazole and 454.5 milligrams trichlorfon.
    (b) Sponsor. See 054771 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use--(1) Amount. 2.5 milligrams of oxfendazole and 
40 milligrams of trichlorfon per kilogram of body weight.
    (2) Indications for use. The drug is used in horses for removal of 
bots (Gasterophilus intestinalis, 2nd and 3rd instars; G. nasalis, 3rd 
instar) and the following gastrointestinal worms: Large roundworms 
(Parascaris equorum), pinworms (Oxyuris equi), adult and 4th stage 
larvae; large strongyles (Strongylus edentatus, S. vulgaris, and S. 
equinus); and small strongyles.
    (3) Limitations. Horses maintained on premises where reinfection is 
likely to occur should be retreated in 6 to 8 weeks. Withholding feed or 
water before use is unnecessary. Administer with caution to sick or 
debilitated horses. Not for use in horses intended for food. Do not 
administer to mares during the last month of pregnancy. Trichlorfon is a 
cholinesterase inhibitor. Do not use this product in animals 
simultaneously with, or within a few days before or after treatment with 
or exposure to, cholinesterase-inhibiting drugs, pesticides, or 
chemicals. Consult your veterinarian for assistance in the diagnosis, 
treatment, and control of parasitism.

[50 FR 50291, Dec. 10, 1985, as amended at 61 FR 5506, Feb. 13, 1996; 78 
FR 28825, May 20, 2014]



Sec. 520.1638  Oxibendazole.

    (a) Specifications. (1) Each gram of paste contains 227 milligrams 
(mg) (22.7 percent) oxibendazole.
    (2) Each milliliter of suspension contains 100 mg (10 percent) 
oxibendazole.
    (b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
    (c) Special considerations. (1) See Sec. 500.25 of this chapter.
    (2) Suspension product described in paragraph (a)(2) of this section 
shall be labeled: ``Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.''
    (d) Conditions of use in horses--(1) Amount. For uses other than for 
threadworms (Strongyloides westeri), 10 mg oxibendazole per kilogram (/
kg) body weight; for threadworms (Strongyloides westeri), 15 mg/kg. 
Horses maintained on premises where reinfection is likely to occur 
should be re-treated in 6 to 8 weeks. Administer suspension product by 
stomach tube in 3 to 4 pints of warm water, or by top dressing or mixing 
into a portion of the normal grain ration.
    (2) Indications for use. For removal and control of large strongyles 
(Strongylus edentatus, S. equinus, S. vulgaris); small strongyles 
(genera Cylicostephanus, Cylicocyclus, Cyathostomum, Triodontophorus, 
Cylicodontophorus, and Gyalocephalus); large roundworms (Parascaris 
equorum); pinworms (Oxyuris equi) including various larval stages; and 
threadworms (Strongyloides westeri).
    (3) Limitations. Do not use in horses intended for human 
consumption.

[78 FR 28825, May 20, 2014]



Sec. 520.1660  Oxytetracycline.



Sec. 520.1660a  Oxytetracycline and carbomycin.

    (a) Specifications. (1) Oxytetracycline: The antibiotic substance 
produced by growth of Streptomyces rimosus or the

[[Page 224]]

same antibiotic substance produced by any other means.
    (2) Carbomycin: The antibiotic substance produced by growth of 
Streptomyces halstedii or the same antibiotic substance produced by any 
other means.
    (b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
    (c) Special considerations. The quantities of oxytetracycline in 
paragraph (e) of this section refer to the activity of oxytetracycline 
hydrochloride and the quantities of carbomycin listed refer to the 
activity of an appropriate standard.
    (d) Related tolerances. See Sec. Sec. 556.110 and 556.500 of this 
chapter.
    (e) Conditions of use. It is used as oxytetracycline hydrochloride 
plus carbomycin base in drinking water of chickens as follows:
    (1) Amount. Administer 1.0 gram of oxytetracycline and 1.0 gram 
carbomycin per gallon for not more than 5 days.
    (2) Indications for use. As an aid in the prevention and treatment 
of complicated chronic respiratory disease (air-sac infection) caused by 
Mycoplasma gallisepticum and secondary bacterial organisms associated 
with chronic respiratory disease such as E. coli.
    (3) Limitations. Not for use in chickens producing eggs for human 
consumption. Withdraw 24 hours before slaughter. Federal law restricts 
this drug to use by or on the order of a licensed veterinarian.

[40 FR 13838, Mar. 27, 1975, as amended at 78 FR 28825, May 20, 2014; 81 
FR 94989, Dec. 27, 2016]



Sec. 520.1660b  Oxytetracycline hydrochloride capsules.

    (a) Specifications. The drug is in capsule form with each capsule 
containing 125 or 250 milligrams of oxytetracycline hydrochloride. 
Oxytetracycline is the antibiotic substance produced by growth of 
Streptomyces rimosus or the same antibiotic substance produced by any 
other means.
    (b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use. (1) It is used in dogs and cats for the 
treatment of bacterial pneumonia caused by Brucella bronchiseptica, 
tonsilitis caused by Streptococcus hemolyticus, bacterial enteritis 
caused by Escherichia coli, urinary tract infections caused by 
Escherichia coli, and wound infections caused by Staphylococcus aureus.
    (2) The drug is administered orally to dogs and cats at a dosage 
level of 25-50 milligrams per pound of body weight per day in divided 
doses at 12-hour intervals. The drug can be used for continuation of 
compatible antibiotic therapy following parenteral oxytetracycline 
administration where rapidly attained, sustained antibiotic blood levels 
are required. The duration of treatment required to obtain favorable 
response will depend to some extent on the severity and degree of 
involvement and the susceptibility of the infectious agent. Clinical 
response to antibiotic therapy usually occurs within 48 to 72 hours. If 
improvement is not observed within that period, the diagnosis and course 
of treatment should be reconsidered. To assure adequate treatment, 
administration of the drug should continue for at least 48 hours 
following favorable clinical response.
    (3) Federal law restricts this drug to use by or on the order of a 
licensed veterinarian.

[40 FR 13838, Mar. 27, 1975, as amended at 78 FR 28825, May 20, 2014]



Sec. 520.1660c  Oxytetracycline hydrochloride tablets/boluses.

    (a) Specifications. Each tablet or bolus contains 250, 500, or 1,000 
milligrams of oxytetracycline hydrochloride.
    (b) Sponsors. For sponsors in Sec. 510.600(c) of this chapter: See 
000010 for use of 500 and 1,000 milligram boluses. See No. 054771 for 
use of 250 and 500 milligram tablets.
    (c) Tolerances. See Sec. 556.500 of this chapter.
    (d) Conditions of use in beef and dairy cattle--(1)(i) Amount. 250 
milligrams per 100 pounds of body weight every 12 hours (5 milligrams 
per pound of body weight daily in two doses).
    (ii) Indications for use. For control of bacterial enteritis caused 
by Salmonella typhimurium and Escherichia coli (colibacillosis) and 
bacterial pneumonia (shipping fever complex, pasteurellosis) caused by 
Pasteurella multocida.

[[Page 225]]

    (2)(i) Amount. 500 milligrams per 100 pound of body weight every 12 
hours (10 milligrams per pound of body weight daily in two doses).
    (ii) Indications for use. For treatment of bacterial enteritis 
caused by Salmonella typhimurium and Escherichia coli (colibacillosis) 
and bacterial pneumonia (shipping fever complex, pasteurellosis) caused 
by Pasteurella multocida.
    (3) Limitations. Dosage should continue until the animal returns to 
normal and for 24 hours to 48 hours after symptoms have subsided. 
Treatment should not exceed 4 consecutive days. Do not exceed 500 
milligrams per 100 pounds of body weight every 12 hours (10 milligrams 
per pound daily). For sponsor No. 054771: Discontinue treatment 7 days 
prior to slaughter. Not for use in lactating dairy cattle. A withdrawal 
period has not been established for this product in preruminating 
calves. Do not use in calves to be processed for veal.

[46 FR 32440, June 23, 1981, as amended at 50 FR 1045, Jan. 9, 1985; 63 
FR 70334, Dec. 21, 1998; 70 FR 16394, Apr. 4, 2005; 78 FR 28825, May 20, 
2014]



Sec. 520.1660d  Oxytetracycline powder.

    (a) Specifications. The drug is a soluble powder distributed in 
packets or pails having several concentrations of oxytetracycline 
hydrochloride (independent of the various net weights) as follows:
    (1) Each 18.14 grams of powder contains 1 gram of oxytetracycline 
hydrochloride (OTC HCl) (packets: 4, 6.4, and 16 oz.).
    (2) Each 4.43 grams of powder contains 1 gram of OTC HCl (packets: 4 
and 16 oz.).
    (3) Each 1.32 grams of powder contains 1 gram of OTC HCl (packets: 
2.39, 4.78, and 9.55 oz.; jars: 2.25 lbs.; and pails: 4.5 lbs.).
    (4) Each 2.73 grams of powder contains 1 gram of OTC HCl (packets: 
2.46 and 9.87 oz, 3.09 and 3.91 lb; pail: 3.09 lb).
    (5) Each 4.2 grams of powder contains 1 gram of OTC HCl (packets: 
3.8 and 15.2 oz; pails: 4.74 and 23.7 lb).
    (6) Each 1.32 grams of powder contains 1 gram of OTC HCl (packet: 
4.78 oz.; pail: 5 lb). Each 2.73 grams of powder contains 1 gram of OTC 
HCl (packet: 9.87 oz).
    (7) Each 1.32 grams of powder contains 1 gram of OTC HCl (packet: 
4.78 and 9.6 oz.; pails: 2 and 5 lb); each 18.1 grams of powder contains 
1 gram of OTC HCl (packet: 6.4 oz.; pails: 2 and 5 lb).
    (8) Each 135.5-gram packet (4.78 ounce) contains 102.4 grams of OTC 
HCl. Each 677.5-gram packet (23.9 ounce) contains 512 grams of OTC HCl.
    (9) Each 2.73 grams of powder contains 1 gram of OTC HCl (packets: 
9.87 and, 19.75 oz, and 3.91 lb; pails: 3.09 and 5 lb).
    (10) Each 2.73 grams of powder contains 1 gram of OTC HCl (packets: 
9.87 and 19.74 oz; pails: 5 lb).
    (b) Sponsor. See sponsor numbers in Sec. 510.600(c) of this chapter 
as follows:
    (1) No. 054771 for use of OTC HCl concentrations in paragraphs 
(a)(1), (a)(2), and (a)(3) of this section in chickens, turkeys, swine, 
cattle, sheep, and honey bees.
    (2) No. 016592 for use of OTC HCl concentration in paragraph (a)(4) 
of this section in chickens, turkeys, and swine.
    (3) No. 066104 for use of OTC HCl concentration in paragraph (a)(5) 
of this section in turkeys and chickens.
    (4) No. 016592 for use of OTC HCl concentration in paragraph (a)(6) 
of this section in chickens, turkeys, and swine.
    (5) No. 061133 for use of OTC HCl concentration in paragraph (a)(7) 
of this section in chickens, turkeys, swine, cattle, sheep, and 
honeybees.
    (6) No. 069254 for use of OTC HCl concentrations in paragraph (a)(8) 
of this section in chickens, turkeys, swine, cattle, sheep, and honey 
bees.
    (7) No. 061133 for use of OTC HCl concentration in paragraph (a)(9) 
of this section in chickens, turkeys, and swine.
    (c) Related tolerances. See Sec. 556.500 of this chapter.
    (d) Conditions of use. (1) It is used in drinking water as follows:
    (i) Chickens--(A)(1) Amount. Administer 200 to 400 milligrams/gallon 
for 7 to 14 days. Not to be used for more than 14 consecutive days.

[[Page 226]]

    (2) Indications for use. Control of infectious synovitis caused by 
Mycoplasma synoviae susceptible to oxytetracycline.
    (3) Do not use in birds producing eggs for human consumption. 
Federal law restricts this drug to use by or on the order of a licensed 
veterinarian.
    (B)(1) Amount. Administer 400 to 800 milligrams/gallon for 7 to 14 
days. Not to be used for more than 14 consecutive days.
    (2) Indications for use. Control of chronic respiratory disease 
(CRD) and air sac infections caused by Mycoplasma gallisepticum and E. 
coli susceptible to oxytetracycline; control of fowl cholera caused by 
Pasteurella multocida susceptible to oxytetracycline.
    (3) Do not use in birds producing eggs for human consumption. 
Federal law restricts this drug to use by or on the order of a licensed 
veterinarian.
    (ii) Turkeys--(A)(1) Amount. Administer 200 to 400 milligrams/gallon 
for 7 to 14 days. Not to be used for more than 14 consecutive days.
    (2) Indications for use. Control of hexamitiasis caused by Hexamita 
meleagridis susceptible to oxytetracycline.
    (3) Do not use in birds producing eggs for human consumption. 
Withdraw 5 days prior to slaughter those products sponsored by Nos. 
054771 and 061133 in Sec. 510.600(c) of this chapter. Withdraw 4 days 
prior to slaughter those products sponsored by No. 054628. Zero-day 
withdrawal for those products sponsored by Nos. 057561 and 069254. 
Federal law restricts this drug to use by or on the order of a licensed 
veterinarian.
    (B)(1) Amount. Administer 400 milligrams/gallon for 7 to 14 days. 
Not to be used for more than 14 consecutive days.
    (2) Indications for use. Control of infectious synovitis caused by 
Mycoplasma synoviae susceptible to oxytetracycline.
    (3) Do not use in birds producing eggs for human consumption. 
Withdraw 5 days prior to slaughter those products sponsored by Nos. 
054771 and 061133 in Sec. 510.600(c) of this chapter. Withdraw 4 days 
prior to slaughter those products sponsored by No. 054628. Zero-day 
withdrawal for those products sponsored by Nos. 057561 and 069254. 
Federal law restricts this drug to use by or on the order of a licensed 
veterinarian.
    (C)(1) Amount. Administer 25 milligrams per pound of body weight 
daily for 7 to 14 days. Not to be used for more than 14 consecutive 
days.
    (2) Indications for use. Growing turkeys. Control of complicating 
bacterial organisms associated with bluecomb (transmissible enteritis, 
coronaviral enteritis) susceptible to oxytetracycline.
    (3) Do not use in birds producing eggs for human consumption. 
Withdraw 5 days prior to slaughter those products sponsored by Nos. 
054771 and 061133 in Sec. 510.600(c) of this chapter. Withdraw 4 days 
prior to slaughter those products sponsored by No. 054628. Zero-day 
withdrawal for those products sponsored by Nos. 057561 and 069254. 
Federal law restricts this drug to use by or on the order of a licensed 
veterinarian.
    (iii) Swine--(A) Amount. Administer 10 milligrams per pound of body 
weight daily for up to 14 days. Do not use for more than 14 consecutive 
days.
    (B) Indications for use. Control and treatment of bacterial 
enteritis caused by Escherichia coli and Salmonella choleraesuis and 
bacterial pneumonia caused by Pasteurella multocida susceptible to 
oxytetracycline. For breeding swine: Control and treatment of 
leptospirosis (reducing the incidence of abortions and shedding of 
leptospira) caused by Leptospira pomona susceptible to oxytetracycline.
    (C) Withdraw zero days prior to slaughter those products sponsored 
by Nos. 054771, 057561, 061133, and 069254 in Sec. 510.600(c) of this 
chapter. Withdraw 4 days prior to slaughter those products sponsored by 
No. 054628. Federal law restricts this drug to use by or on the order of 
a licensed veterinarian.
    (iv) Calves, beef cattle, and nonlactating dairy cattle--(A) Amount. 
Administer 10 milligrams per pound of body weight daily for up to 14 
days. Do not use for more than 14 consecutive days.
    (B) Indications for use. Control and treatment of bacterial 
enteritis caused by E. coli and bacterial pneumonia (shipping fever 
complex) caused by P. multocida susceptible to oxytetracycline.
    (C) Withdraw 5 days prior to slaughter. A milk discard period has 
not been

[[Page 227]]

established for this product in lactating dairy cattle. Do not use in 
female dairy cattle 20 months of age or older. Federal law restricts 
this drug to use by or on the order of a licensed veterinarian.
    (v) Sheep--(A) Amount. Administer 10 milligrams per pound of body 
weight daily for up to 14 days. Not to be used for more than 14 
consecutive days.
    (B) Indications for use. Control and treatment of bacterial 
enteritis caused by E. coli and bacterial pneumonia (shipping fever 
complex) caused by P. multocida susceptible to oxytetracycline.
    (C) Withdraw 5 days prior to slaughter. Federal law restricts this 
drug to use by or on the order of a licensed veterinarian.
    (2) It is used in the food of honey bees as follows:
    (i) Amount. 200 milligrams per colony, administered via either a 1:1 
sugar syrup (equal parts of sugar and water weight to weight) or dusting 
with a powdered sugar mixture. The drug is administered in 3 
applications of sugar syrup or 3 dustings at 4- to 5-day intervals.
    (ii) Indications for use. For control of American foulbrood caused 
by Paenibacillus larvae.
    (iii) The drug should be fed early in the spring or fall and 
consumed by the bees before main honey flow begins to avoid 
contamination of production honey. Remove at least 6 weeks prior to main 
honey flow. Federal law restricts this drug to use by or on the order of 
a licensed veterinarian.

[40 FR 13838, Mar. 27, 1975]

    Editorial Note: For Federal Register citations affecting Sec. 
520.1660d, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and at www.govinfo.gov.



Sec. 520.1696  Penicillin.



Sec. 520.1696a  Penicillin G powder.

    (a) Specifications. Each gram of powder contains penicillin G 
potassium equivalent to 1.54 million units of penicillin G.
    (b) Sponsors. See Nos. 010515, 016592, 054771, 061133 and 076475 in 
Sec. 510.600(c) of this chapter.
    (c) Related tolerances. See Sec. 556.510 of this chapter.
    (d) Conditions of use in turkeys--(1) Amount. 1,500,000 units per 
gallon drinking water for 5 days.
    (2) Indications for use. Treatment of erysipelas caused by 
Erysipelothrix rhusiopathiae.
    (3) Limitations. Discontinue treatment at least 1 day prior to 
slaughter. Not for use in turkeys producing eggs for human consumption. 
Federal law restricts this drug to use by or on the order of a licensed 
veterinarian.

[57 FR 37326, Aug. 18, 1992, as amended at 59 FR 42493, Aug. 18, 1994; 
60 FR 26359, May 17, 1995; 62 FR 55160, Oct. 23, 1997; 65 FR 10705, Feb. 
29, 2000; 66 FR 14073, Mar. 9, 2001; 68 FR 4914, Jan. 31, 2003; 68 FR 
26204, May 15, 2003; 69 FR 9946, Mar. 3, 2004; 69 FR 41428, July 9, 
2004; 77 FR 20988, Apr. 9, 2012; 78 FR 28825, May 20, 2014; 81 FR 22523, 
Apr. 18, 2016; 81 FR 36789, June 8, 2016; 81 FR 94990, Dec. 27, 2016; 84 
FR 8973, Mar. 13, 2019. Redesignated at 85 FR 18119, Apr. 1, 2020]



Sec. 520.1696b  Penicillin V powder.

    (a) Specifications. When reconstituted, each milliliter contains 25 
milligrams (40,000 units) of penicillin V.
    (b) Sponsor. See No. 000010 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in dogs and cats--(1) Amount. 10 to 15 
milligrams per pound of body weight every 6 to 8 hours.
    (2) Indications for use. Treatment of respiratory, urogenital, skin, 
and soft tissue infections and septicemia caused by pathogens 
susceptible to penicillin V potassium.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[57 FR 37326, Aug. 18, 1992; 57 FR 42623, Sept. 15, 1992; 77 FR 20988, 
Apr. 9, 2012; 78 FR 28826, May 20, 2014; 84 FR 39183, Aug. 9, 2019. 
Redesignated at 85 FR 18119, Apr. 1, 2020]



Sec. 520.1696c  Penicillin V tablets.

    (a) Specifications. Each tablet contains penicillin V potassium 
equivalent to 125 milligrams (200,000 units) or 250 milligrams (400,000 
units) of penicillin V.
    (b) Sponsors. See Nos. 000010 and 054771 in Sec. 510.600(c) of this 
chapter.
    (c) Conditions of use in dogs and cats--(1) Amount. 10 to 15 
milligrams per

[[Page 228]]

pound of body weight every 6 to 8 hours.
    (2) Indications for use. Treatment of respiratory, urogenital, skin 
and soft tissue infections and septicemia caused by pathogens 
susceptible to penicillin V potassium.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[57 FR 37327, Aug. 18, 1992, as amended at 59 FR 58775, Nov. 15, 1994; 
78 FR 28826, May 20, 2014; 84 FR 39183, Aug. 9, 2019. Redesignated at 85 
FR 18119, Apr. 1, 2020]



Sec. 520.1705  Pergolide.

    (a) Specifications. Each tablet contains 1 milligram (mg) peroglide 
(as pergolide mesylate).
    (b) Sponsor. See No. 000010 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in horses--(1) Amount. Administer orally at a 
starting dose of 2 micrograms/kilograms ([micro]/kg) once daily. Dosage 
may be adjusted to effect, not to exceed 4 [micro]g/kg daily.
    (2) Indications for use. For the control of clinical signs 
associated with Pituitary Pars Intermedia Dysfunction (Equine Cushing's 
Disease).
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[77 FR 15960, Mar. 19, 2012, as amended at 81 FR 22523, Apr. 18, 2016]



Sec. 520.1720  Phenylbutazone oral dosage forms.



Sec. 520.1720a  Phenylbutazone tablets and boluses.

    (a) Specifications. Each tablet contains 100, 200, or 400 milligrams 
(mg), or 1 gram (g) of phenylbutazone. Each bolus contains 1, 2, or 4 
gram g of phenylbutazone.
    (b) Sponsors. See sponsor numbers in Sec. 510.600(c) of this 
chapter, as follows:
    (1) No. 000061 for use of 100- or 400-mg or 1-g tablets, or 2- or 4-
g boluses, in dogs and horses.
    (2) No. 069043 for use of 100- or 200-mg or 1-g tablets in dogs and 
horses.
    (3) Nos. 054771 and 061133 for use of 100-mg or 1-g tablets in dogs 
and horses.
    (4) No. 058829 for use of 100-mg or 1-g tablets in dogs and horses.
    (5) No. 058198 for use of 1-g tablets in horses.
    (c) Conditions of use--(1) Dogs--(i) Amount. 20 mg per pound of body 
weight daily.
    (ii) Indications for use. For the relief of inflammatory conditions 
associated with the musculoskeletal system.
    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.
    (2) Horses--(i) Amount. 1 to 2 g per 500 pounds of body weight 
daily.
    (ii) Indications for use. For the relief of inflammatory conditions 
associated with the musculoskeletal system.
    (iii) Limitations. Do not use in horses intended for human 
consumption. Federal law prohibits the use of this drug in female dairy 
cattle 20 months of age or older. Federal law restricts this drug to use 
by or on the order of a licensed veterinarian.

[73 FR 8192, Feb. 13, 2008, as amended at 74 FR 1146, Jan. 12, 2009; 76 
FR 11331, Mar. 2, 2011; 76 FR 17777, Mar. 31, 2011; 78 FR 21060, Apr. 9, 
2013; 78 FR 28826, May 20, 2014; 81 FR 17607, Mar. 30, 2016; 83 FR 
48946, Sept. 28, 2018; 84 FR 8973, Mar. 13, 2019; 85 FR 45307, July 28, 
2020; 86 FR 14819, Mar. 19, 2021]



Sec. 520.1720b  Phenylbutazone granules.

    (a) Specifications. Each package of granules contains 1 or 8 grams 
of phenylbutazone.
    (b) Sponsors. See sponsors in Sec. 510.600(c) of this chapter.
    (1) No. 000061 for 8-gram package.
    (2) No. 059320 for 1-gram package.
    (c) Conditions of use in horses--(1) Amount. Administer 1 to 2 grams 
per 500 pounds of body weight, not to exceed 4 grams, daily as required. 
by adding to a portion of the usual grain ration.
    (2) Indications for use. For the treatment of inflammatory 
conditions associated with the musculoskeletal system.
    (3) Limitations. Do not use in horses intended for human 
consumption. Federal law prohibits the use of this drug in female dairy 
cattle 20 months of age or older. Federal law restricts this drug to use 
by or on the order of a licensed veterinarian.

[78 FR 28826, May 20, 2014]

[[Page 229]]



Sec. 520.1720c  Phenylbutazone paste.

    (a) Specifications. (1) Each gram of paste contains 0.2 grams 
phenylbutazone.
    (2) Each gram of paste contains 0.35 grams phenylbutazone.
    (b) Sponsors. See sponsor numbers in Sec. 510.600(c) of this 
chapter.
    (1) No. 000061 for use of product described in paragraph (a)(1) of 
this section.
    (2) No. 017030 for use of product described in paragraph (a)(2) of 
this section.
    (c) Conditions of use in horses--(1) Amount. 1 to 2 grams of 
phenylbutazone per 500 pounds of body weight, not to exceed 4 grams 
daily.
    (2) Indications for use. For relief of inflammatory conditions 
associated with the musculoskeletal system.
    (3) Limitations. Do not use in horses intended for human 
consumption. Federal law prohibits the use of this drug in female dairy 
cattle 20 months of age or older. Federal law restricts this drug to use 
by or on the order of a licensed veterinarian.

[45 FR 84762, Dec. 23, 1980, as amended at 58 FR 29777, May 24, 1993; 61 
FR 8873, Mar. 6, 1996; 62 FR 61625, Nov. 19, 1997; 68 FR 43926, July 25, 
2003; 72 FR 60550, Oct. 25, 2007; 77 FR 4897, Feb. 1, 2012; 78 FR 28826, 
May 20, 2014; 79 FR 74020, Dec. 15, 2014]



Sec. 520.1720d  Phenylbutazone gel.

    (a) Specifications. Each 30 grams of gel contains 4 grams of 
phenylbutazone.
    (b) Sponsor. See No. 061133 in Sec. 510.600(c) of this chapter. 
require bioequivalency and safety information.
    (c) Conditions of use in horses--(1) Amount. 1 to 2 grams of 
phenylbutazone per 500 pounds of body weight, not to exceed 4 grams 
daily.
    (2) Indications for use. For relief of inflammatory conditions 
associated with the musculoskeletal system of horses.
    (3) Limitations. Do not use in horses intended for human 
consumption. Federal law prohibits the use of this drug in female dairy 
cattle 20 months of age or older. Federal law restricts this drug to use 
by or on the order of a licensed veterinarian.

[50 FR 13561, Apr. 5, 1985, as amended at 50 FR 49372, Dec. 2, 1985; 55 
FR 8462, Mar. 8, 1990; 66 FR 14073, Mar. 9, 2001; 68 FR 4915, Jan. 31, 
2003; 78 FR 28826, May 20, 2014; 84 FR 8973, Mar. 13, 2019]



Sec. 520.1720e  Phenylbutazone powder.

    (a) Specifications. (1) Each 1.15 grams (g) of powder contains 1 g 
phenylbutazone.
    (2) Each 10 g of powder contains 1 g phenylbutazone.
    (b) Sponsors. See sponsor numbers in Sec. 510.600(c) of this 
chapter.
    (1) No. 027053 for use of product described in paragraph (a)(1) of 
this section.
    (2) No. 057699 for use of product described in paragraph (a)(2) of 
this section.
    (c) Conditions of use in horses--(1) Amount. Administer 1 to 2 g (1 
to 2 level scoops, using the scoop provided) per 500 pounds of body 
weight on a small amount of palatable feed, not exceed 4 g per animal 
daily.
    (2) Indications for use. For the relief of inflammatory conditions 
associated with the musculosketetal system.
    (3) Limitations. Do not use in horses intended for human 
consumption. Federal law prohibits the extralabel use of this product in 
female cattle 20 months of age or older. Federal law restricts this drug 
to use by or on the order of a licensed veterinarian.

[72 FR 27956, May 18, 2007]



Sec. 520.1760  Phenylpropanolamine.

    (a) Specifications. (1) Each chewable tablet contains 25, 50, or 75 
milligram (mg) phenylpropanolamine hydrochloride.
    (2) Each extended-release tablet contains 18, 38, 74, or 145 mg 
phenylpropanolamine hydrochloride.
    (b) Sponsors. See No. 055246 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in dogs--(1) Amount. Administer orally as 
follows:
    (i) Chewable tablet: 2 mg/kg of body weight twice daily.
    (ii) Extended-release tablet: 2 to 4 mg/kg of body weight once daily 
with food.

[[Page 230]]

    (2) Indications for use. For the control of urinary incontinence due 
to urethral sphincter hypotonus in dogs.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[77 FR 15961, Mar. 19, 2012, as amended at 84 FR 39183, Aug. 9, 2019]



Sec. 520.1780  Pimobendan.

    (a) Specifications. Each chewable tablet contains 1.25, 2.5, 5, or 
10 milligrams (mg) pimobendan.
    (b) Sponsor. See No. 000010 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in dogs--(1) Amount. Administer orally at a 
total daily dose of 0.23 mg per pound (0.5 mg per kilogram) body weight, 
using a suitable combination of whole or half tablets. The total daily 
dose should be divided into two portions administered approximately 12 
hours apart.
    (2) Indications for use. For the management of the signs of mild, 
moderate, or severe (modified New York Heart Association Class II, III, 
or IV) congestive heart failure due to atrioventricular valvular 
insufficiency or dilated cardiomyopathy; for use with concurrent therapy 
for congestive heart failure as appropriate on a case-by-case basis.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[72 FR 27733, May 17, 2007, as amended at 79 FR 18158, Apr. 1, 2014]



Sec. 520.1802  Piperazine-carbon disulfide complex oral dosage forms.



Sec. 520.1802a  Piperazine-carbon disulfide complex suspension.

    (a) Specifications. Each fluid ounce of suspension contains 7.5 
grams of piperazine-carbon disulfide complex. The piperazine-carbon 
disulfide complex contains equimolar parts of piperazine and carbon 
disulfide (1 gram contains 530 mgs of piperazine and 470 mgs of carbon 
disulfide).
    (b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in horses and ponies--(1) Amount. Administer 1 
fluid ounce per 100 pounds of body weight by stomach tube or dose 
syringe after withholding feed overnight or for 8 to 10 hours.
    (2) Indications for use. For removing ascarids (large roundworms, 
Parascaris equorum), bots (Gastrophilus spp.), small strongyles, large 
strongyles (Strongyles spp.), and pinworms (Oxyuris equi).
    (3) Limitations. Do not use in horses intended for human 
consumption. Federal law restricts this drug to use by or on the order 
of a licensed veterinarian.

[45 FR 52781, Aug. 8, 1980, as amended at 78 FR 28826, May 20, 2014]



Sec. 520.1802b  Piperazine-carbon disulfide complex boluses.

    (a) Specifications. Each bolus contains 20 grams of piperazine-
carbon disulfide complex.
    (b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in horses and ponies--(1) Amount. For removal 
of ascarids and small strongyles, 1 bolus (20 grams) per 500 pounds body 
weight; removal of large strongyles, pinworms, and bots, 1 bolus per 250 
pounds body weight.
    (2) Indications for use. For removing ascarids (large roundworms, 
Parascaris equorum), large strongyles (Strongylus spp.) bots 
(Gastrophilus spp.), small strongyles, and pinworms (Oxyuris equi).
    (3) Limitations. Withhold feed overnight or for 8 to 10 hours. Give 
water just before and/or after treatment. Resume regular feeding 4 to 6 
hours after treatment. Treatment of debilitated or anemic animals is 
contraindicated. Do not administer to animals that are or were recently 
affected with colic, diarrhea, or infected with a serious infectious 
disease. As with most anthelmintics, drastic cathartics or other 
gastrointestinal irritants should not be administered in conjunction 
with this drug. Animals in poor condition or heavily parasitized should 
be given one half the recommended dose and treated again in 2 or 3 
weeks. Consult your veterinarian for assistance in the diagnosis, 
treatment, and control of parasitism.

[45 FR 52782, Aug. 8, 1980, as amended at 78 FR 28826, May 20, 2014]

[[Page 231]]



Sec. 520.1802c  Piperazine-carbon disulfide complex with phenothiazine
suspension.

    (a) Specifications. Each fluid ounce contains 5 grams of piperazine-
carbon disulfide complex and 0.83 gram of phenothiazine.
    (b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in horses and ponies--(1) Amount. Administer 1 
fluid ounce per 100 pounds of body weight by stomach tube or dose 
syringe after withholding feed overnight or for 8 to 10 hours.
    (2) Indications for use. For removing ascarids (large roundworms, 
Parascaris equorum), bots (Gastrophilus spp.), small strongyles, and 
large strongyles (Strongylus spp.).
    (3) Limitations. Do not use in horses intended for human 
consumption. Federal law restricts this drug to use by or on the order 
of a licensed veterinarian.

[45 FR 52782, Aug. 8, 1980, as amended at 78 FR 28826, May 20, 2014]



Sec. 520.1803  Piperazine citrate capsules.

    (a) Specifications. Each capsule contains piperazine citrate 
equivalent to 140 milligrams of piperazine base.
    (b) Sponsor. See No. 021091 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in dogs and cats--(1) Amount. The contents of 
1 capsule should be mixed with the food of the animal for each 5 pounds, 
or fraction thereof of body weight, except dogs weighing over 25 pounds 
should be given the contents of 6 capsules. The drug should be mixed in 
1/2 of the regular feeding and when the animal has finished eating the 
dosed food, the remainder of the food may be given. Dogs and cats may be 
wormed at 6 to 8 weeks of age. The first treatment should be repeated 10 
days later. Reinfection may occur. Repeat treatment if indicated.
    (2) Indications for use. For the removal of large roundworms 
(Toxocara canis and Toxascaris leonina).
    (3) Limitations. Severely debilitated animals should not be treated 
except on the advice of a veterinarian.

[40 FR 13838, Mar. 27, 1975, as amended at 54 FR 38515, Sept. 19, 1989; 
78 FR 28826, May 20, 2014]



Sec. 520.1805  Piperazine phosphate with thenium closylate tablets.

    (a) Specifications. Each scored tablet contains the equivalent of 
250 milligrams piperazine hexahydrate (as piperazine phosphate) and 125 
milligrams thenium (as thenium closylate) or 500 milligrams piperazine 
hexahydrate (as piperazine phosphate) and 250 milligrams thenium (as 
thenium closylate).
    (b) Sponsor. See No. 000061 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use--(1) Amount. Administer orally to dogs as 
follows:

               Number of Tablets at Each of the Two Doses
------------------------------------------------------------------------
                Animal weight (lb)                    375 mg     750 mg
------------------------------------------------------------------------
2 but less than 5.................................      \1/2\  .........
5 but less than 10................................          1      \1/2\
10 or heavier.....................................          2          1
------------------------------------------------------------------------

    (2) Indications for use. For removal of immature (fourth stage 
larvae) and adult hookworms (Ancylostoma caninum, A. braziliense, and 
Uncinaria stenocephala) and ascarids (Toxocara canis) from weaned pups 
and adult dogs.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[43 FR 32747, July 28, 1978, as amended at 47 FR 55476, Dec. 10, 1982; 
61 FR 8873, Mar. 6, 1996; 62 FR 61625, Nov. 19, 1997; 78 FR 28826, May 
20, 2014]



Sec. 520.1806  Piperazine suspension.

    (a) Specifications. Each milliliter of suspension contains 
piperazine monohydrochloride equivalent to 33.5 milligrams (mg) 
piperazine base.
    (b) Sponsor. See No. 017135 in Sec. 510.600(c) of this chapter.
    (c) Special considerations. See Sec. 500.25(c) of this chapter.
    (d) Conditions of use in dogs--(1) Indications for use. For the 
removal of roundworms (Toxocara canisand Toxascaris leonina).
    (2) Dosage. Administer 20 to 30 mg piperazine base per pound body 
weight as a single dose.
    (3) Limitations. Administer by mixing into the animal's ration to be 
consumed at one feeding. For animals in heavily contaminated areas, 
reworm at monthly intervals. Not for use in

[[Page 232]]

unweaned pups or animals less than 3 weeks of age.

[70 FR 17319, Apr. 6, 2005]



Sec. 520.1840  Poloxalene.

    (a) Specifications. Polyoxypropylene-polyoxyethylene glycol nonionic 
block polymer.
    (b) Sponsors. See sponsors in Sec. 510.600(c) of this chapter for 
use as in paragraph (d) of this section.
    (1) No. 054771 for use as in paragraphs (d)(1) and (d)(3) of this 
section.
    (2) No. 067949 for use as in paragraph (d)(2) of this section.
    (3) No. 066104 for use as in paragraph (d)(3) of this section.
    (c) Related tolerances. See Sec. 556.517 of this chapter.
    (d) Conditions of use. (1) For treatment of legume (alfalfa, clover) 
bloat in cattle. Administer as a drench at the rate of 25 grams for 
animals up to 500 pounds and 50 grams for animals over 500 pounds of 
body weight.
    (2) For control of legume (alfalfa, clover) bloat in cattle. 
Administer, in molasses block containing 6.6 percent poloxalene, at the 
rate of 0.8 oz. of block (1.5 grams poloxalene) per 100 lbs. of body 
weight per day.
    (3) For prevention of legume (alfalfa, clover) and wheat pasture 
bloat in cattle. A 53-percent poloxalene top dressing on individual 
rations of ground feed. Dosage is 1 gram of poloxalene per 100 pounds of 
body weight daily. If bloating conditions are severe, the dose is 
doubled. Treatment should be started 2 to 3 days before exposure to 
bloat-producing conditions. Repeat use of the drug if animals are 
exposed to bloat-producing conditions for more than 12 hours after the 
last treatment. Do not exceed the double dose in any 24-hour period.

[40 FR 13838, Mar. 27, 1975, as amended at 40 FR 39857, Aug. 29, 1975; 
42 FR 41854, Aug. 19, 1977; 50 FR 5385, Feb. 8, 1985; 54 FR 33501, Aug. 
15, 1989; 56 FR 50653, Oct. 8, 1991; 58 FR 26523, May 4, 1993; 60 FR 
55659, Nov. 2, 1995; 66 FR 47963, Sept. 17, 2001; 69 FR 62811, Oct. 28, 
2004; 70 FR 32489, June 3, 2005; 78 FR 28826, May 20, 2014; 83 FR 48946, 
Sept. 28, 2018; 84 FR 32992, July 11, 2019]



Sec. 520.1846  Polyoxyethylene (23) lauryl ether blocks.

    (a) Specifications. Each molasses-based block contains 2.2 percent 
polyoxyethylene (23) lauryl ether.
    (b) Sponsor. See No. 067949 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use--(1) Amount. 2 grams of polyoxyethylene (23) 
lauryl ether per 100 kilograms of body weight per day (1 pound of block 
per 500 kilogram (1,100 pound) animal per day).
    (2) Indications for use. For reduction of the incidence of bloat 
(alfalfa and clover) in pastured cattle.
    (3) Limitations. Administer free-choice to beef cattle and 
nonlactating dairy cattle only. Initially, provide one block per five 
head of cattle. Start treatment 10 to 14 days before exposure to bloat-
producing pastures. Do not allow cattle access to other sources of salt 
while being fed this product. Do not feed this product to animals 
without adequate forage/roughage consumption.

[50 FR 48189, Nov. 22, 1985, as amended at 56 FR 9841, Mar. 8, 1991; 69 
FR 62811, Oct. 28, 2004]



Sec. 520.1855  Ponazuril.

    (a) Specifications. Each gram of paste contains 150 milligrams (mg) 
ponazuril.
    (b) Sponsor. See No. 000010 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in horses--(1) Amount. Administer orally 15 mg 
per kilogram (kg) (6.81 mg per pound (lb)) body weight as the first 
dose, followed by 5 mg/kg (2.27 mg/lb) body weight once daily for a 
period of 27 additional days.
    (2) Indications for use. For the treatment of equine protozoal 
myeloencephalitis caused by Sarcocystis neurona.
    (3) Limitations. Do not use in horses intended for human 
consumption. Federal law restricts this drug to use by or on the order 
of a licensed veterinarian.

[66 FR 43774, Aug. 21, 2001, as amended at 79 FR 28827, May 20, 2014; 80 
FR 34278, June 16, 2015; 80 FR 53459, Sept. 4, 2015; 84 FR 39183, Aug. 
9, 2019]

[[Page 233]]



Sec. 520.1860  Pradofloxacin.

    (a) Specifications. Each milliliter of suspension contains 25 
milligrams (mg) pradofloxacin.
    (b) Sponsor. See No. 058198 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in cats--(1) Amount. Administer 3.4 mg/lb (7.5 
mg/kg) body weight once daily for 7 consecutive days.
    (2) Indications for use. For the treatment of skin infections 
(wounds and abscesses) in cats caused by susceptible strains of 
Pasteurella multocida, Streptococcus canis, Staphylococcus aureus, 
Staphylococcus felis, and Staphylococcus pseudintermedius.
    (3) Limitations. Federal law prohibits the extralabel use of this 
drug in food-producing animals. Federal law restricts this drug to use 
by or on the order of a licensed veterinarian.

[77 FR 76863, Dec. 31, 2012, as amended at 79 FR 28827, May 20, 2014; 86 
FR 14819, Mar. 19, 2021]



Sec. 520.1870  Praziquantel tablets.

    (a) Specifications. Each tablet contains:
    (1) 34 milligrams (mg) praziquantel.
    (2) 11.5 or 23 mg praziquantel.
    (b) Sponsors. See sponsors in Sec. 510.600(c) of this chapter.
    (1) No. 058198 for use of product described in paragraph (a)(1) of 
this section as in paragraph (c)(1) of this section and for use of 
product described in paragraph (a)(2) of this section as in paragraph 
(c)(2) of this section.
    (2) No. 069043 for use of product described in paragraph (a)(1) of 
this section as in paragraphs (c)(1) of this section.
    (c) Conditions of use--(1) Dogs--(i) Amount. 5 pounds (lb) and 
under, \1/2\ tablet (17 mg); 6 to 10 lb, 1 tablet (34 mg); 11 to 15 lb, 
1\1/2\ tablets (51 mg); 16 to 30 lb, 2 tablets (68 mg); 31 to 45 lb, 3 
tablets (102 mg); 46 to 60 lb, 4 tablets (136 mg); over 60 lb, 5 tablets 
maximum (170 mg). Administer directly by mouth or crumbled and in feed.
    (ii) Indications for use--(A) For removal of canine cestodes 
Dipylidium caninum and Taenia pisiformis.
    (B) For removal of the canine cestode Echinococcus granulosus, and 
for removal and control of the canine cestode Echinococcus 
multilocularis.
    (iii) Limitations--(A) If labeled only for use as in paragraph 
(c)(1)(ii)(A) of this section: Not intended for use in puppies less than 
4 weeks of age. Consult your veterinarian before administering tablets 
to weak or debilitated animals and for assistance in the diagnosis, 
treatment, and control of parasitism.
    (B) If labeled for use as in paragraph (c)(1)(ii)(B) of this 
section: Federal law restricts this drug to use by or on the order of a 
licensed veterinarian.
    (2) Cats--(i) Indications for use. For removal of feline cestodes 
Dipylidium caninum and Taenia taeniaeformis.
    (ii) Dosage. Cats 4 pounds and under, 11.5 mg; 5 to 11 pounds, 23 
mg; over 11 pounds, 34.5 mg.
    (iii) Limitations. Administer directly by mouth or crumbled and in 
feed. Not intended for use in kittens less than 6 weeks of age. For OTC 
use: Consult your veterinarian before administering tablets to weak or 
debilitated animals, and for assistance in the diagnosis, treatment, and 
control of parasitism.

[46 FR 60570, Dec. 11, 1981, as amended at 47 FR 26377, June 18, 1982; 
55 FR 2234, Jan. 23, 1990; 58 FR 7864, Feb. 10, 1993; 58 FR 42853, Aug. 
12, 1993; 68 FR 57351, Oct. 3, 2003; 69 FR 62181, Oct. 25, 2004; 78 FR 
17596, Mar. 22, 2013; 81 FR 17607, Mar. 30, 2016; 86 FR 14819, Mar. 19, 
2021]



Sec. 520.1871  Praziquantel and pyrantel.

    (a) Specifications. (1) Each tablet contains 13.6 milligrams (mg) 
praziquantel and 54.3 mg pyrantel base (as pyrantel pamoate), 18.2 mg 
praziquantel and 72.6 mg pyrantel base (as pyrantel pamoate), or 27.2 mg 
praziquantel and 108.6 mg pyrantel base (as pyrantel pamoate).
    (2) Each chewable tablet contains 30 mg praziquantel and 30 mg 
pyrantel pamoate or 114 mg praziquantel and 114 mg pyrantel pamoate.
    (b) Sponsors. See sponsors in Sec. 510.600(c) for use as in 
paragraph (d) of this chapter.
    (1) See No. 058198 for use of tablets described in paragraph (a)(1) 
of this section for use as in paragraph (d)(1) of this section.
    (2) See No. 051311 for use of tablets described in paragraph (a)(2) 
of this section for use as in paragraph (d)(2) of this section.

[[Page 234]]

    (c) Special considerations. See Sec. 500.25 of this chapter.
    (d) Conditions of use--(1) Cats--(i) Dosage. Administer a minimum 
dose of 2.27 mg praziquantel and 9.2 mg pyrantel pamoate per pound of 
body weight according to the dosing tables on labeling. May be given 
directly by mouth or in a small amount of food. Do not withhold food 
prior to or after treatment. If reinfection occurs, treatment may be 
repeated.
    (ii) Indications for use. For removal of tapeworms (Dipylidium 
caninum and Taenia taeniaeformis), hookworms (Ancylostoma tubaeforme), 
and large roundworms (Toxocara cati) in cats and kittens.
    (iii) Limitations. Not for use in kittens less than 2 months of age 
or weighing less than 2.0 pounds. Consult your veterinarian before 
giving to sick or pregnant animals.
    (2) Dogs--(i) Amount. Administer a minimum dose of 5 mg praziquantel 
and 5 mg pyrantel pamoate per kilogram body weight (2.27 mg praziquantel 
and 2.27 mg pyrantel pamoate per pound body weight) according to the 
dosing tables on labeling.
    (ii) Indications for use. For the treatment and control of 
roundworms (Toxocara canis and Toxascaris leonina), hookworms 
(Ancylostoma caninum, Ancylostoma braziliense, and Uncinaria 
stenocephala), and tapeworms (Dipylidium caninum and Taenia pisiformis) 
in dogs and puppies.

[58 FR 58652, Nov. 3, 1993, as amended at 72 FR 16270, Apr. 4, 2007; 75 
FR 54018, Sept. 3, 2010; 86 FR 14819, Mar. 19, 2021]



Sec. 520.1872  Praziquantel, pyrantel pamoate, and febantel tablets.

    (a) Specifications. Each tablet or chewable tablet contains either:
    (1) Tablet No. 1: 22.7 milligrams praziquantel, 22.7 milligrams 
pyrantel base, and 113.4 milligrams febantel; or
    (2) Tablet No. 2: 68 milligrams praziquantel, 68 milligrams pyrantel 
base, and 340.2 milligrams febantel.
    (3) Tablet No. 3: 136 milligrams (mg) praziquantel, 136 mg pyrantel 
base, and 680.4 mg febantel.
    (b) Sponsor. See No. 058198 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use--(1) Dogs--(i) Amount. Administer as a single 
dose directly by mouth or in a small amount of food as follows:

----------------------------------------------------------------------------------------------------------------
                  Weight of animal                                    Number of tablets per dose
----------------------------------------------------------------------------------------------------------------
            Kilograms                   Pounds           Tablet no. 1        Tablet no. 2        Tablet no. 3
----------------------------------------------------------------------------------------------------------------
0.9 to 1.8......................  2 to 4............  1/2...............
2.3 to 3.2......................  5 to 7............  1.................
3.6 to 5.4......................  8 to 12...........  1 1/2.............
5.9 to 8.2......................  13 to 18..........  2.................
8.6 to 11.4.....................  19 to 25..........  2 1/2.............
11.8 to 13.6....................  26 to 30..........  ..................  1.................
14.1 to 20.0....................  31 to 44..........  ..................  1 1/2.............
20.4 to 27.2....................  45 to 60..........  ..................  2.................  1
27.7 to 40.9....................  61 to 90..........  ..................  ..................  1 1/2
41.3 to 54.5....................  91 to 120.........  ..................  ..................  2
----------------------------------------------------------------------------------------------------------------

    (ii) Indications for use. For the removal of tapeworms (Dipylidium 
caninum, Taenia pisiformis, Echinococcus granulosus); hookworms 
(Ancylostoma caninum, Uncinaria stenocephala); ascarids (Toxocara canis, 
Toxascaris leonina); and whipworms (Trichuris vulpis) and for the 
removal and control of tapeworm Echinococcus multilocularis in dogs.
    (iii) Limitations. Do not use in pregnant animals. Do not use in 
dogs weighing less than 0.9 kilogram (2 pounds) or puppies less than 3 
weeks of age. Federal law restricts this drug to use by or on the order 
of a licensed veterinarian.

[59 FR 33908, July 1, 1994, as amended at 61 FR 29651, June 12, 1996; 68 
FR 22293, Apr. 28, 2003; 71 FR 6677, Feb. 9, 2006; 86 FR 14819, Mar. 19, 
2021]



Sec. 520.1880  Prednisolone.

    (a) Specifications. Each tablet contains 5 or 20 milligrams 
prednisolone.
    (b) Sponsor. See No. 061690 in Sec. 510.600(c)(2) of this chapter.
    (c) Conditions of use in dogs--(1) Amount. Administer 2.5 milligrams 
per 4.5 kilograms (10 pounds) body weight per day. Administer total 
daily dose orally in equally divided doses 6 to 10 hours apart until 
response is noted or 7 days have elapsed. When response is attained, 
dosage should be gradually reduced until maintenance level is achieved.
    (2) Indications for use. For use as an anti-inflammatory agent.

[[Page 235]]

    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[57 FR 4718, Feb. 7, 1992, as amended at 60 FR 57832, Nov. 22, 1995; 63 
FR 148, Jan. 5, 1998; 79 FR 28827, May 20, 2014]



Sec. 520.1900  Primidone.

    (a) Specifications. Each tablet contains 50 or 250 milligrams of 
primidone.
    (b) Sponsors. See sponsor numbers in Sec. 510.600(c) of this 
chapter.
    (1) No. 069043 for use of 250 milligram tablets.
    (2) No. 054771 for use of 50 and 250 milligram tablets.
    (c) Conditions of use in dogs--(1) Amount. Twenty-five milligrams of 
primidone per pound of body weight (55 milligrams per kilogram of body 
weight) daily.
    (2) Indications for use. For the control of convulsions associated 
with idiopathic epilepsy, epileptiform convulsions, viral encephalitis, 
distemper, and hardpad disease that occurs as a clinically recognizable 
lesion in certain entities in dogs.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[42 FR 61594, Dec. 6, 1977, as amended at 43 FR 55386, Nov. 28, 1978; 46 
FR 8467, Jan. 27, 1981; 46 FR 57477, Nov. 24, 1981; 53 FR 40727, Oct. 
18, 1988; 56 FR 37473, Aug. 7, 1991; 62 FR 35076, June 30, 1997; 78 FR 
21060, Apr. 9, 2013; 79 FR 28827, May 20, 2014; 83 FR 48946, Sept. 28, 
2018]



Sec. 520.1920  Prochlorperazine and isopropamide.

    (a) Specifications. Each capsules contains either:
    (1) 3.33 milligrams of prochlorperazine (as the dimaleate) and 1.67 
milligrams of isopropamide (as the iodide); or
    (2) 10 milligrams of prochlorperazine (as the dimaleate) and 5 
milligrams of isopropamide (as the iodide).
    (b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in dogs--(1) Amount. (i) Capsules described in 
paragraph (a)(1) of this section are administered orally to dogs 
weighing from 4 to 15 pounds at the rate of 1 capsule twice daily. These 
capsules are administered orally to dogs weighing from 16 to 30 pounds 
at the rate of 1 or 2 capsules twice daily. For dogs weighing less than 
4 pounds, administer orally an appropriate fraction of the contents of 
one of these capsules.
    (ii) Capsules described in paragraph (a)(2) of this section are 
given to dogs weighing 30 pounds and over at the rate of 1 capsule twice 
daily.
    (2) Indications for use. For the treatment of gastrointestinal 
disturbances associated with emotional stress.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[79 FR 28827, May 20, 2014]



Sec. 520.1921  Prochlorperazine, isopropamide, and neomycin.

    (a) Specifications. Each capsule contains either:
    (1) Capsule No. 1: 3.33 milligrams of prochlorperazine (as the 
dimaleate), 1.67 milligrams of isopropamide (as the iodide), and 25 
milligrams of neomycin base (as the sulfate); or
    (2) Capsule No. 3: 10 milligrams of prochlorperazine (as the 
dimaleate), 5 milligrams of isopropamide (as the iodide), and 75 
milligrams of neomycin base (as the sulfate).
    (b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in dogs--(1) Amount. Administer capsules 
orally twice daily to dogs as follows:

------------------------------------------------------------------------
                                                      Number of capsules
                                                           per dose
               Animal weight (pounds)                -------------------
                                                       Capsule   Capsule
                                                        No. 1     No. 3
------------------------------------------------------------------------
10 to 20............................................         1
20 to 30............................................         2
Over 30.............................................         3         1
Over 60.............................................                   2
------------------------------------------------------------------------

    (2) Indications for use. For the treatment infectious bacterial 
gastroenteritis associated with emotional stress.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[49 FR 14103, Apr. 10, 1984, as amended at 56 FR 50653, Oct. 8, 1991; 60 
FR 55659, Nov. 2, 1995; 79 FR 28827, May 20, 2014]



Sec. 520.1962  Promazine.

    (a) Specifications. Conforms to N.F. XII for promazine 
hydrochloride.

[[Page 236]]

    (b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in horses--(1) Amount. Administer 0.45 to 0.9 
milligrams per pound of body weight mixed with an amount of feed that 
will be readily consumed.
    (2) Indications for use. For quieting excitable, unruly, or 
intractable horses.
    (3) Limitations. Do not use in horses intended for human 
consumption. Federal law restricts this drug to use by or on the order 
of a licensed veterinarian.

[79 FR 28827, May 20, 2014]



Sec. 520.2002  Propiopromazine.

    (a) Specifications. Each chewable tablet contains 10 or 20 
milligrams of propiopromazine hydrochloride.
    (b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in dogs--(1) Amount. Administer 0.5 to 2.0 
milligrams per pound of body weight once or twice daily, depending upon 
the degree of tranquilization desired.
    (2) Indications for use. For oral administration as a tranquilizer. 
As an aid in handling difficult, excited, and unruly dogs, and in 
controlling excessive kennel barking, car sickness, and severe 
dermatitis. It is also indicated for use in minor surgery and prior to 
routine examinations, laboratory procedures, and diagnostic procedures.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[79 FR 28827, May 20, 2014]



Sec. 520.2041  Pyrantel pamoate chewable tablets.

    (a) Specifications. Each tablet contains pyrantel pamoate equivalent 
to 22.7 or 113.5 milligrams pyrantel base.
    (b) Sponsor. See Nos. 017135 and 051311 in Sec. 510.600(c) of this 
chapter.
    (c) Conditions of use--(1) Amount. Provides at least 2.27 milligrams 
pyrantel base per pound body weight for dogs weighing more than 5 
pounds, and at least 4.54 milligrams of pyrantel base per pound body 
weight for dogs weighing 5 pounds or less.
    (2) Indications for use--(i) In dogs and puppies. For removal of 
ascarids (Toxocara canis; Toxascaris leonina) and hookworms (Ancylostoma 
caninum; Uncinaria stenocephala).
    (ii) In puppies and adult dogs and in lactating bitches after 
whelping. To prevent reinfection of Toxocara canis.
    (3) Limitations. Administer to puppies at 2, 3, 4, 6, 8, and 10 
weeks of age. Administer to lactating bitches 2 to 3 weeks after 
whelping. Retreatment of adult dogs may be necessary at monthly 
intervals as determined by laboratory fecal examinations. Consult your 
veterinarian for assistance in the diagnosis, treatment, and control of 
parasitism.

[52 FR 37937, Oct. 13, 1987, as amended at 57 FR 48163, Oct. 22, 1992; 
58 FR 44611, Aug. 24, 1993; 66 FR 9650, Feb. 9, 2001; 67 FR 21996, May 
2, 2002; 81 FR 22523, Apr. 18, 2016; 82 FR 12169, Mar. 1, 2017; 84 FR 
8973, Mar. 13, 2019]



Sec. 520.2042  Pyrantel pamoate tablets.

    (a) Specifications. Each tablet contains pyrantel pamoate equivalent 
to 22.7, 45.4, or 113.5 milligrams of pyrantel base.
    (b) Sponsor. See No. 017135 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use. It is used for dogs as follows:
    (1) Amount. For dogs weighing over 5 pounds, use at least 2.27 
milligrams of pyrantel base per pound of body weight; for dogs weighing 
5 pounds or less, use at least 4.54 milligrams of pyrantel base per 
pound of body weight.
    (2) Indications for use. For removal and control of large roundworms 
(ascarids) (Toxocara canis and Toxascaris leonina), and hookworms 
(Ancylostoma caninum and Uncinaria stenocephala).
    (3) Limitations. Administer orally directly or in a small amount of 
food. To prevent reinfection of T. canis in puppies, lactating bitches 
after whelping, and adult dogs; treat puppies 2, 3, 4, 6, 8, and 10 
weeks of age; treat lactating bitches 2 to 3 weeks after whelping; 
routinely treat adult dogs monthly. Do not withhold food prior to or 
after treatment. The presence of these parasites should be confirmed by 
laboratory fecal examination. A followup fecal examination should be 
conducted

[[Page 237]]

2 to 4 weeks after first treatment regimen to determine the need for re-
treatment. Consult your veterinarian for assistance in the diagnosis, 
treatment, and control of parasitism.

[43 FR 52700, Nov. 14, 1978, as amended at 49 FR 22073, May 25, 1984; 57 
FR 48163, Oct. 22, 1992; 58 FR 44611, Aug. 24, 1993]



Sec. 520.2043  Pyrantel pamoate suspension.

    (a) Specifications. (1) Each milliliter (mL) contains pyrantel 
pamoate equivalent to 50 milligrams (mg) pyrantel base.
    (2) Each mL contains pyrantel pamoate equivalent to 2.27 or 4.54 mg 
pyrantel base.
    (3) Each mL contains pyrantel pamoate equivalent to 4.54 mg pyrantel 
base.
    (b) Sponsors. See sponsors in Sec. 510.600(c) of this chapter for 
uses as in paragraph (d) of this section.
    (1) Nos. 054771, 058829, and 069043 for use of the product described 
in paragraph (a)(1) as in paragraph (d)(1) of this section.
    (2) Nos. 054771, 058198, and 058829 for use of the products 
described in paragraph (a)(2) of this section as in paragraph (d)(2) of 
this section.
    (3) No. 023851 for use of the product described in paragraph (a)(3) 
as in paragraph (d)(2) of this section.
    (c) Special considerations. See Sec. 500.25 of this chapter.
    (d) Conditions of use--(1) Horses and ponies. It is used as follows:
    (i) Amount. 3 mg per pound (/lb) body weight as a single dose mixed 
with the usual grain ration, or by stomach tube or dose syringe.
    (ii) Indications for use. For the removal and control of mature 
infections of large strongyles (Strongylus vulgaris, S. edentatus, S. 
equinus); pinworms (Oxyuris equi); large roundworms (Parascaris 
equorum); and small strongyles.
    (iii) Limitations. Do not use in horses intended for human 
consumption. When the drug is for administration by stomach tube, it 
shall be labeled: ``Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.''
    (2) Dogs. It is used as follows:
    (i) Dogs and puppies--(A) Amount. 2.27 mg/lb body weight as a single 
dose in the animal's feed bowl by itself or mixed in a small quantity of 
food.
    (B) Indications for use. For the removal of large roundworms 
(Toxocara canis and Toxascaris leonina) and hookworms (Ancylostoma 
caninum and Uncinaria stenocephala).
    (C) Limitations. Additional treatment may be required and should be 
confirmed by fecal examination within 2 to 4 weeks.
    (ii) Dogs, puppies, and lactating bitches after whelping--(A) 
Amount. 2.27 mg/lb body weight.
    (B) Indications for use. To prevent reinfections of T. canis.
    (C) Limitations. Administer to puppies at 2, 3, 4, 6, 8, and 10 
weeks of age. Administer to lactating bitches 2 to 3 weeks after 
whelping. Adult dogs kept in heavily contaminated quarters may be 
treated at monthly intervals.

[67 FR 43248, June 27, 2002, as amended at 68 FR 54803, Sept. 19, 2003; 
68 FR 55199, Sept. 23, 2003; 68 FR 55825, Sept. 29, 2003; 75 FR 52622, 
Aug. 27, 2010; 76 FR 17337, Mar. 29, 2011; 78 FR 17596, Mar. 22, 2013; 
79 FR 28827, May 20, 2014; 80 FR 76386, Dec. 9, 2015; 81 FR 17607, Mar. 
30, 2016; 86 FR 14819, Mar. 19, 2021]



Sec. 520.2044  Pyrantel pamoate paste.

    (a) Specifications--(1) Each milliliter (mL) contains 180 milligrams 
(mg) pyrantel base (as pyrantel pamoate).
    (2) Each mL contains 226 mg pyrantel base (as pyrantel pamoate).
    (3) Each mL contains 171 mg pyrantel base (as pyrantel pamoate).
    (b) Sponsors. See sponsors in Sec. 510.600(c) of this chapter.
    (1) No. 054771 for use of product described in paragraph (a)(1) of 
this section as in paragraph (d)(1)(i) and (d)(2) of this section.
    (2) No. 017135 for use of product described in paragraph (a)(2) of 
this section as in paragraph (d) of this section.
    (3) No. 061133 for use of product described in paragraph (a)(3) of 
this section as in paragraph (d)(1)(i) and (d)(2) of this section.
    (c) Special considerations. See Sec. 500.25 of this chapter.
    (d) Conditions of use. It is used in horses and ponies as follows:

[[Page 238]]

    (1) Amounts and indications for use. (i) 3 mg per pound (/lb) body 
weight as single oral dose for removal and control of infections from 
the following mature parasites: large strongyles (Strongylus vulgaris, 
S. edentatus, S. equinus); small strongyles; pinworms (Oxyuris equi); 
and large roundworms (Parascaris equorum).
    (ii) 6 mg/lb body weight as single oral dose for the removal and 
control of mature infections of tapeworms (Anoplocephala perfoliata).
    (2) Limitations. Do not use in horses intended for human 
consumption.

[70 FR 29447, May 23, 2005, as amended at 76 FR 17337, Mar. 29, 2011; 78 
FR 17596, Mar. 22, 2013; 79 FR 28827, May 20, 2014; 81 FR 17607, Mar. 
30, 2016; 84 FR 8973, Mar. 13, 2019]



Sec. 520.2045  Pyrantel tartrate powder.

    (a) Specifications. Each gram of powder contains 106 milligrams 
(10.6 percent) or 113 milligrams (11.3 percent) pyrantel tartrate.
    (b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter for 
use of 11.3 percent powder as in paragraph (d)(1) and 10.6 percent 
powder as in paragraph (d)(2) and of this section.
    (c) Related tolerances. See Sec. 556.560 of this chapter.
    (d) Conditions of use--(1) Horses--(i) Amount. Administer as a 
single dose at 0.57 gram of pyrantel tartrate per 100 pounds of body 
weight mixed with the usual grain ration. Do not administer by stomach 
tube or dose syringe.
    (ii) Indications for use. For the removal and control of infections 
from the following mature parasites: Large strongyles (Strongylus 
vulgaris, S. edentatus, S. equinus), small strongyles (Trichonema spp., 
Triodontophorus), pinworms (Oxyuris), and large roundworms (Parascaris).
    (iii) Limitations. Do not treat severely debilitated animals with 
this drug. Do not use in horses intended for human consumption.
    (2) Swine--(i) Amount. Add to feed at 0.4 gram pyrantel tartrate per 
pound of non-pelleted ration. The ration is administered as a single 
treatment as the sole ration at the rate of 1 pound per 40 pounds of 
animal weight for animals up to 200 pounds. Animals 200 pounds and over 
are administered 5 pounds of ration per animal.
    (ii) Indications for use. For the removal and control of large 
roundworms (Ascaris suum) and nodular worm (Oesophagostomum) infections.
    (iii) Limitations. Consult veterinarian before using in severely 
debilitated animals. Do not treat within 24 hours of slaughter.

[79 FR 28827, May 20, 2014]



Sec. 520.2046  Pyrantel tartrate pellets.

    (a) Specifications. (1) Each gram of pellets contains 12.5 
milligrams (mg) (1.25 percent) pyrantel tartrate; or
    (2) Each gram of pellets contains 21.1 mg (2.11 percent) pyrantel 
tartrate.
    (b) Sponsors. See sponsor numbers in Sec. 510.600(c) of this 
chapter:
    (1) No. 054771 for use of products described in paragraph (a) as in 
paragraph (c) of this section.
    (2) No. 061133 for use of product described in paragraph (a)(1) as 
in paragraph (c) of this section.
    (c) Conditions of use in horses--(1) Amount. Administer as a single 
dose at 12.5 mg per 2.2 pounds of body weight mixed with the usual grain 
ration.
    (2) Indications for use. For the removal and control of infections 
from the following mature parasites: Large strongyles (Strongylus 
vulgaris, S. edentatus, S. equinus), small strongyles (Trichonema spp., 
Triodontophorus), pinworms (Oxyuris), and large roundworms (Parascaris).
    (3) Limitations. Do not treat severely debilitated animals with this 
drug. Do not use in horses intended for human consumption.

[79 FR 28828, May 20, 2014, as amended at 84 FR 8973, Mar. 13, 2019]



Sec. 520.2075  Robenacoxib.

    (a) Specifications. Each tablet contains 10, 20, or 40 milligrams 
(mg) robenacoxib for use in dogs, or 6 mg robenacoxib for use in cats.
    (b) Sponsors. See No. 058198 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use--(1) Dogs--(i) Amount. Administer 0.91 mg/lb 
(2 mg/kg) orally, once daily, for a maximum of 3 days.
    (ii) Indications for use. For the control of postoperative pain and 
inflammation associated with soft tissue surgery in dogs weighing at 
least 5.5 lb (2.5 kg)

[[Page 239]]

and at least 4 months of age for a maximum of 3 days.
    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.
    (2) Cats--(i) Amount. Administer 0.45 mg/lb (1 mg/kg) orally, once 
daily, for a maximum of 3 days.
    (ii) Indications for use. For the control of postoperative pain and 
inflammation associated with orthopedic surgery, ovariohysterectomy, and 
castration in cats weighing at least 5.5 lb (2.5 kg) and at least 4 
months of age for a maximum of 3 days.
    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

[76 FR 18648, Apr. 5, 2011, as amended at 79 FR 10964, Feb. 27, 2014; 81 
FR 59133, Aug. 29, 2016]



Sec. 520.2086  Sarolaner.

    (a) Specifications. Each chewable tablet contains 5, 10, 20, 40, 80, 
or 120 milligrams (mg) sarolaner.
    (b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in dogs--(1) Amount. Administer orally once a 
month at the recommended minimum dosage of 0.9 mg/lb (2 mg/kg).
    (2) Indications for use. Kills adult fleas, and for the treatment 
and prevention of flea infestations (Ctenocephalides felis), and the 
treatment and control of tick infestations [Amblyomma americanum (lone 
star tick), Amblyomma maculatum (Gulf Coast tick), Dermacentor 
variabilis (American dog tick), Ixodes scapularis (black-legged tick), 
and Rhipicephalus sanguineus (brown dog tick)] for 1 month in dogs 6 
months of age or older and weighing 2.8 pounds or greater.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[81 FR 22523, Apr. 18, 2016, as amended at 82 FR 12169, Mar. 1, 2017]



Sec. 520.2090  Sarolaner, moxidectin, and pyrantel.

    (a) Specifications. Each chewable tablet contains:
    (1) 3.0 mg sarolaner, 0.06 mg moxidectin, and 12.5 milligrams (mg) 
pyrantel (as pamoate salt);
    (2) 6.0 mg sarolaner, 0.12 mg moxidectin, and 25.0 mg pyrantel (as 
pamoate salt);
    (3) 12.0 mg sarolaner, 0.24 mg moxidectin, and 50.0 mg pyrantel (as 
pamoate salt);
    (4) 24.0 mg sarolaner, 0.48 mg moxidectin, and 100 mg pyrantel (as 
pamoate salt);
    (5) 48.0 mg sarolaner, 0.96 mg moxidectin, and 200 mg pyrantel (as 
pamoate salt); or
    (6) 72.0 mg sarolaner, 1.44 mg moxidectin, and 300 mg pyrantel (as 
pamoate salt).
    (b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in dogs--(1) Amount. Administer orally, once a 
month, at the recommended minimum dose of 0.54 mg/lb (1.2 mg/kg) 
sarolaner, 0.011 mg/lb (24 [micro]g/kg) moxidectin, and 2.27 mg/lb (5 
mg/kg) pyrantel (as pamoate salt).
    (2) Indications for use. Prevents heartworm disease caused by 
Dirofilaria immitis, kills adult fleas (Ctenocephalides felis) and is 
indicated for the treatment and prevention of flea infestations, the 
treatment and control of tick infestations with Amblyomma americanum 
(lone star tick), Amblyomma maculatum (Gulf Coast tick), Dermacentor 
variabilis (American dog tick), Ixodes scapularis (black-legged tick), 
and Rhipicephalus sanguineus (brown dog tick), and the treatment and 
control of roundworm (immature adult and adult Toxocara canis and adult 
Toxascaris leonina) and adult hookworm (Ancylostoma caninum and 
Uncinaria stenocephala) infections for 1 month in dogs and puppies 8 
weeks of age and older, and weighing 2.8 pounds or greater.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[85 FR 45307, July 28, 2020]



Sec. 520.2098  Selegiline.

    (a) Specifications. Each tablet contains 2, 5, 10, 15, or 30 
milligrams (mg) selegiline hydrochloride.
    (b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in dogs--(1) Amounts and indications for use. 
(i) Administer 1 mg per kilogram (0.45 mg

[[Page 240]]

per pound) of body weight once daily for control of clinical signs 
associated with uncomplicated pituitary-dependent hyperadrenocorticism 
in dogs.
    (ii) Administer 0.5 to 1.0 mg per kilogram of body weight once daily 
for the control of clinical signs associated with canine cognitive 
dysfunction syndrome.
    (2) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[79 FR 28828, May 20, 2014]



Sec. 520.2100  Selenium and vitamin E.

    (a) Specifications. Each capsule contains:
    (1) 2.19 milligrams (mg) sodium selenite (equivalent to 1 mg 
selenium) and 56.2 mg (68 I.U.) vitamin E as d-alpha tocopheryl acid 
succinate; or
    (2) 0.548 mg sodium selenite (equivalent to 0.25 mg selenium) and 14 
mg (17 I.U.) vitamin E as d-alpha tocopheryl acid succinate.
    (b) Sponsor. See No. 000061 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in dogs--(1) Amount. (i) Dogs over 20 pounds: 
Administer 1 capsule described in paragraph (a)(1) per 20 pounds of body 
weight to a maximum of 5 capsules. Repeat at 3 day intervals until a 
satisfactory therapeutic response is observed. Maintenance dosage is 1 
capsule per 40 pounds of body weight every 3 to 7 days, or longer, as 
required.
    (ii) Dogs under 20 pounds: Administer 1 capsule described in 
paragraph (a)(2) per 5 pounds of body weight with a minimum of 1 
capsule. Repeat at 3-day intervals until a satisfactory response is 
observed. Maintenance dosage is 1 capsule per 10 pounds of body weight 
every 3 to 7 days, or longer, as required.
    (2) Indications for use. As an aid in alleviating and controlling 
inflammation, pain, and lameness associated with certain arthropathies.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[79 FR 28828, May 20, 2014]



Sec. 520.2123  Spectinomycin oral dosage forms.



Sec. 520.2123a  Spectinomycin tablets.

    (a) Specifications. Each tablet contains spectinomycin 
dihydrochloride equivalent to 100 milligrams (mg) spectinomycin.
    (b) Sponsors. See Nos. 054771 and 061133 in Sec. 510.600(c) of this 
chapter.
    (c) Conditions of use in dogs--(1) Amount. Administer orally to 
provide 10 mg per pound (lb) of body weight twice daily. Dosage may be 
continued for 4 consecutive days.
    (2) Indications for use. For the treatment of infectious diarrhea 
and gastroenteritis caused by organisms susceptible to spectinomycin.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[73 FR 6607, Feb. 5, 2008, as amended at 79 FR 28828, May 20, 2014; 84 
FR 8973, Mar. 13, 2019]



Sec. 520.2123b  Spectinomycin powder.

    (a) Specifications. Each gram (g) of powder contains spectinomycin 
dihydrochloride pentahydrate equivalent to 0.5 g spectinomycin.
    (b) Sponsor. See No. 061133 in Sec. 510.600(c) of this chapter.
    (c) Related tolerances. See Sec. 556.600 of this chapter.
    (d) Conditions of use in chickens. It is administered in the 
drinking water of growing chickens as follows:
    (1) Indications for use and amounts. (i) As an aid in controlling 
infectious synovitis due to Mycoplasma synoviae in broiler chickens, 
administer 1 g per gallon of water as the only source of drinking water 
for the first 3 to 5 days of life.
    (ii) As an aid in the prevention or control of losses due to CRD 
associated with M. gallisepticum (PPLO) in growing chickens, administer 
2 g per gallon of water as the only source of drinking water for the 
first 3 days of life and for 1 day following each vaccination.
    (2) Limitations. Do not administer to laying chickens. Do not 
administer within 5 days of slaughter. Federal law restricts this drug 
to use by or on the order of a licensed veterinarian.

[73 FR 6607, Feb. 5, 2008, as amended at 81 FR 94990, Dec. 27, 2016; 84 
FR 8973, Mar. 13, 2019]

[[Page 241]]



Sec. 520.2123c  Spectinomycin solution.

    (a) Specifications. Each milliliter of solution contains 
spectinomycin dihydrochloride pentahydrate equivalent to 50 milligrams 
(mg) spectinomycin.
    (b) Sponsors. See Nos. 016592, 054771, and 061133 in Sec. 
510.600(c) of this chapter.
    (c) Related tolerances. See Sec. 556.600 of this chapter.
    (d) Conditions of use in swine--(1) Amount. Administer 5 mg per 
pound (lb) of body weight orally twice daily for 3 to 5 days.
    (2) Indications for use. For the treatment and control of porcine 
enteric colibacillosis (scours) caused by E. coli susceptible to 
spectinomycin in pigs under 4 weeks of age.
    (3) Limitations. Do not administer to pigs over 15 lb body weight or 
over 4 weeks of age. Do not administer within 21 days of slaughter.

[73 FR 6607, Feb. 5, 2008, as amended at 78 FR 17596, Mar. 22, 2013; 79 
FR 28828, May 20, 2014; 81 FR 22523, Apr. 18, 2016; 84 FR 8973, Mar. 13, 
2019]



Sec. 520.2130  Spinosad.

    (a) Specifications. Each chewable tablet contains 90, 140, 270, 560, 
810, or 1620 milligrams (mg) spinosad.
    (b) Sponsor. See No. 058198 in Sec. 510.600 of this chapter.
    (c) Special considerations. Federal law restricts this drug to use 
by or on the order of a licensed veterinarian.
    (d) Conditions of use--(1) Dogs--(i) Amount. Administer tablets once 
a month at a recommended minimum dosage of 13.5 mg per pound (30 mg per 
kilogram) of body weight.
    (ii) Indications for use. To kill fleas and for the prevention and 
treatment of flea infestations (Ctenocephalides felis) for 1 month on 
dogs and puppies 14 weeks of age and older and 3.3 pounds of body weight 
or greater.
    (2) Cats--(i) Amount. Administer tablets once a month at a minimum 
dosage of 22.5 mg per pound (50 mg per kilogram) of body weight.
    (ii) Indications for use. To kill fleas and for the prevention and 
treatment of flea infestations (C. felis) for 1 month on cats and 
kittens 14 weeks of age and older and 2 pounds of body weight or 
greater.

[77 FR 60623, Oct. 4, 2012, as amended at 81 FR 48702, July 26, 2016]



Sec. 520.2134  Spinosad and milbemycin.

    (a) Specifications. Each chewable tablet contains 140 milligrams 
(mg) spinosad and 2.3 mg milbemycin oxime, 270 mg spinosad and 4.5 mg 
milbemycin oxime, 560 mg spinosad and 9.3 mg milbemycin oxime, 810 mg 
spinosad and 13.5 mg milbemycin oxime, or 1,620 mg spinosad and 27 mg 
milbemycin oxime.
    (b) Sponsor. See No. 058198 in Sec. 510.600 of this chapter.
    (c) Conditions of use in dogs--(1) Amount. Administer once a month 
at a minimum dosage of 13.5 mg/pound (lb) (30 mg/kilogram (kg)) of body 
weight spinosad and 0.2 mg/lb (0.5 mg/kg) of body weight milbemycin 
oxime.
    (2) Indications for use. To kill fleas; for the prevention and 
treatment of flea infestations (Ctenocephalides felis); for the 
prevention of heartworm disease (Dirofilaria immitis); and for the 
treatment and control of adult hookworm (Ancylostoma caninum), adult 
roundworm (Toxocara canis and Toxascaris leonina), and adult whipworm 
(Trichuris vulpis) infections in dogs and puppies 8 weeks of age or 
older and 5 lbs of body weight or greater.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[76 FR 12563, Mar. 8, 2011, as amended at 81 FR 48702, July 26, 2016]



Sec. 520.2138  Spironolactone and benazepril.

    (a) Specifications. Each chewable tablet contains 20 milligrams (mg) 
spironolactone and 2.5 mg benazepril hydrochloride, 40 mg spironolactone 
and 5 mg benazepril hydrochloride, or 80 mg spironolactone and 10 mg 
benazepril hydrochloride.
    (b) Sponsor. See No. 013744 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in dogs--(1) Amount. Administer orally once 
daily, with food, at a dose of 0.9 mg per pound (lb) (2 mg per kilogram 
(kg)) spironolactone and 0.11 mg/lb (0.25 mg/

[[Page 242]]

kg) benazepril hydrochloride, according to dog body weight using a 
suitable combination of whole and/or half tablets.
    (2) Indications for use. With concurrent therapy (e.g., furosemide, 
etc.) for the management of clinical signs of mild, moderate, or severe 
congestive heart failure in dogs due to atrioventricular valvular 
insufficiency (AVVI).
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[86 FR 14819, Mar. 19, 2021]



Sec. 520.2150  Stanozolol.

    (a) Specifications. Each tablet or chewable tablet contains 2 
milligrams stanozolol.
    (b) Sponsor. No. 054771 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in dogs and cats--(1) Amount--(i) Dogs: 
Administered orally to small breeds, \1/2\ to 1 tablet twice daily for 
several weeks; to large breeds, 1 to 2 tablets twice daily for several 
weeks. The tablets may be crushed and administered in feed.
    (ii) Cats: Administered orally \1/2\ to 1 tablet twice daily for 
several weeks.
    (2) Indications for use. As an anabolic steroid treatment.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[79 FR 28828, May 20, 2014]



Sec. 520.2158  Streptomycin.

    (a) Specifications. Each milliliter of solution contains 250 
milligrams (25 percent) streptomycin sulfate.
    (b) Sponsor. See No. 016592 in Sec. 510.600(c) of this chapter.
    (c) Related tolerances. See Sec. 556.610 of this chapter.
    (d) Conditions of use. Use in drinking water as follows:
    (1) Calves--(i) Amount. 10 to 15 milligrams per pound (mg/pound) of 
body weight (1.0 to 1.5 grams per gallon) for up to 5 days.
    (ii) Indications for use. For the treatment of bacterial enteritis 
caused by Escherichia coli and Salmonella spp. susceptible to 
streptomycin.
    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.
    (2) Swine--(i) Amount. 10 to 15 mg/pound of body weight (1.0 to 1.5 
grams per gallon) for up to 4 days.
    (ii) Indications for use. For the treatment of bacterial enteritis 
caused by Escherichia coli and Salmonella spp. susceptible to 
streptomycin.
    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.
    (3) Chickens--(i) Amount. 10 to 15 mg/pound of body weight (0.6 to 
0.9 grams per gallon) for up to 5 days.
    (ii) Indications for use. For the treatment of nonspecific 
infectious enteritis caused by organisms susceptible to streptomycin.
    (iii) Limitations. Withdraw 4 days before slaughter. Do not 
administer to chickens producing eggs for human consumption. Federal law 
restricts this drug to use by or on the order of a licensed 
veterinarian.

[57 FR 37327, Aug. 18, 1992, as amended at 58 FR 47211, Sept. 8, 1993; 
63 FR 51821, Sept. 29, 1998. Redesignated and amended at 79 FR 28828, 
May 20, 2014; 79 FR 74020, Dec. 15, 2014; 80 FR 18776, Apr. 8, 2015; 80 
FR 61296, Oct. 13, 2015]



Sec. 520.2170  Sulfabromomethazine.

    (a) Specifications. Each bolus contains 15 grams of 
sulfabromomethazine sodium.
    (b) Sponsor. See No. 000010 in Sec. 510.600(c) of this chapter.
    (c) Related tolerance. See Sec. 556.620 of this chapter.
    (d) Conditions of use in cattle--(1) Amount. Administer 90 
milligrams per pound body weight orally. Repeat in 48 hours if necessary
    (2) Indications for use. Treatment of necrotic pododermatitis (foot 
rot) and calf diphtheria caused by Fusobacterium necrophorum; 
colibacillosis (scours) caused by Escherichia coli; bacterial pneumonia 
and bovine respiratory disease complex (shipping fever complex) 
associated with Pasteurella spp.; acute metritis and acute mastitis 
caused by Streptococcus spp.
    (3) Limitations. Milk taken from animals within 96 hours (8 
milkings) of latest treatment must not be used for

[[Page 243]]

food. Do not administer within 18 days of slaughter.

[47 FR 30243, July 13, 1982, as amended at 62 FR 63270, Nov. 28, 1997; 
79 FR 28829, May 20, 2014; 84 FR 39183, Aug. 9, 2019]



Sec. 520.2184  Sulfachloropyrazine.

    (a) Specifications. Each gram of powder contains 476 milligrams of 
sodium sulfachloropyrazine monohydrate.
    (b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
    (c) Related tolerance. See Sec. 556.625 of this chapter.
    (d) Conditions of use in chickens. It is used in the drinking water 
of broilers, breeder flocks, and replacement chickens as follows:
    (1) Amount. Administer in drinking water as 0.03 percent solution 
for 3 days.
    (2) Indications for use. For the treatment of coccidiosis.
    (3) Limitations. Withdraw 4 days prior to slaughter. Do not use in 
chickens producing eggs for human consumption. Federal law restricts 
this drug to use by or on the order of a licensed veterinarian.

[79 FR 28829, May 20, 2014, as amended at 81 FR 94990, Dec. 27, 2016]




Sec. 520.2200  Sulfachlorpyridazine.

    (a) Specifications. (1) Sodium sulfachlorpyridazine powder.
    (2) Each bolus contains 2 grams sulfachlorpyridazine.
    (3) Each tablet contains 250 milligrams (mg) sulfachlorpyridazine.
    (b) Sponsor. See No. 016592 in Sec. 510.600(c) of this chapter.
    (c) Related tolerances. See Sec. 556.630 of this chapter.
    (d) Conditions of use. It is used as follows:
    (1) Calves--(i) Amount. Administer 30 to 45 mg sulfachlorpyridazine 
powder per pound (/lb) of body weight per day in milk or milk replacer, 
or in a bolus, in divided doses twice daily for 1 to 5 days.
    (ii) Indications for use. For the treatment of diarrhea caused or 
complicated by Escherichia coli (colibacillosis).
    (iii) Limitations. Treated ruminating calves must not be slaughtered 
for food during treatment or for 7 days after the last treatment. A 
withdrawal period has not been established for this product in 
preruminating calves. Do not use in calves to be processed for veal. 
Federal law restricts this drug to use by or on the order of a licensed 
veterinarian.
    (2) Swine--(i) Amount. Administer 20 to 35 mg/lb body weight per 
day, in divided doses twice daily for 1 to 5 days:
    (A) In drinking water or
    (B) For individual treatment, in an oral suspension containing 50 mg 
per milliliter.
    (ii) Indications for use. For the treatment of diarrhea caused or 
complicated by E. coli (colibacillosis).
    (iii) Limitations. Treated swine must not be slaughtered for food 
during treatment or for 4 days after the last treatment. Federal law 
restricts this drug to use by or on the order of a licensed 
veterinarian.
    (3) Dogs--(i) Amount. Administer tablets orally at 500 mg per 10 to 
15 lb of body weight daily, in two or three divided doses.
    (ii) Indications for use. As an aid in the treatment of infectious 
tracheobronchitis and infections caused by E. coli, and in the treatment 
of infections caused by other Gram-positive and Gram-negative organisms 
that are susceptible to sulfonamide therapy.
    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

[75 FR 10166, Mar. 5, 2010, as amended at 79 FR 28829, May 20, 2014; 81 
FR 17607, Mar. 30, 2016; 81 FR 94990, Dec. 27, 2016]



Sec. 520.2215  Sulfadiazine/pyrimethamine suspension.

    (a) Specifications. Each milliliter (mL) of suspension contains 250 
milligrams (mg) sulfadiazine (as the sodium salt) and 12.5 mg 
pyrimethamine.
    (b) Sponsor. See No. 055246 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in horses--(1) Amount. Administer orally 20 mg 
sulfadiazine per kilogram (kg) body weight and 1 mg/kg pyrimethamine 
daily.
    (2) Indications for use. For the treatment of equine protozoal 
myeloencephalitis (EPM) caused by Sarcocystis neurona.

[[Page 244]]

    (3) Limitations. Do not use in horses intended for human 
consumption. Federal law restricts this drug to use by or on the order 
of a licensed veterinarian.

[69 FR 70054, Dec. 2, 2004, as amended at 73 FR 53686, Sept. 17, 2008; 
75 FR 69586, Nov. 15, 2010]



Sec. 520.2218  Sulfamerazine, sulfamethazine, and sulfaquinoxaline powder.

    (a) Specifications. Each 195-gram (g) packet of powder contains 78 g 
sulfamerazine, 78 g sulfamethazine, and 39 g sulfaquinoxaline.
    (b) Sponsor. See No. 016592 in Sec. 510.600(c) of this chapter.
    (c) Related tolerances. See Sec. Sec. 556.660, 556.670, and 556.685 
of this chapter.
    (d) Conditions of use--(1) Chickens--(i) Amounts and indications for 
use. (A) As an aid in the control of coccidiosis caused by Eimeria 
tenella and E. necatrix susceptible to sulfamerazine, sulfamethazine, 
and sulfaquinoxaline: Provide medicated water (0.04 percent solution) 
for 2 to 3 days, then plain water for 3 days, then medicated water 
(0.025 percent solution) for 2 days. If bloody droppings appear, repeat 
at 0.025 percent level for 2 more days. Do not change litter.
    (B) As an aid in the control of acute fowl cholera caused by 
Pasteurella multocida susceptible to sulfamerazine, sulfamethazine, and 
sulfaquinoxaline: Provide medicated water (0.04 percent solution) for 2 
to 3 days. If disease recurs, repeat treatment.
    (ii) Limitations. Do not treat chickens within 14 days of slaughter 
for food. Do not medicate chickens producing eggs for human consumption. 
Federal law restricts this drug to use by or on the order of a licensed 
veterinarian.
    (2) Turkeys--(i) Amounts and indications for use. (A) As an aid in 
the control of coccidiosis caused by Eimeria meleagrimitis and E. 
adenoeides susceptible to sulfamerazine, sulfamethazine, and 
sulfaquinoxaline: Provide medicated water (0.025 percent solution) for 2 
days, then plain water for 3 days, then medicated water (0.025 percent 
solution) for 2 days, then plain water for 3 days, then medicated water 
(0.025 percent solution) for 2 days. Repeat if necessary. Do not change 
litter.
    (B) As an aid in the control of acute fowl cholera caused by 
Pasteurella multocida susceptible to sulfamerazine, sulfamethazine, and 
sulfaquinoxaline: Provide medicated water (0.04 percent solution) for 2 
to 3 days. If disease recurs, repeat treatment.
    (ii) Limitations. Do not treat turkeys within 14 days of slaughter 
for food. Do not medicate turkeys producing eggs for human consumption. 
Federal law restricts this drug to use by or on the order of a licensed 
veterinarian.

[71 FR 13001, Mar. 14, 2006, as amended at 79 FR 28829, May 20, 2014; 80 
FR 34278, June 16, 2015; 81 FR 22523, Apr. 18, 2016; 81 FR 94990, Dec. 
27, 2016; 85 FR 18119, Apr. 1, 2020]



Sec. 520.2220  Sulfadimethoxine oral dosage forms.



Sec. 520.2220a  Sulfadimethoxine oral solution and soluble powder.

    (a) Specifications. (1) Each ounce of solution contains 3.75 grams 
(12.5 percent) sulfadimethoxine.
    (2) Each 107 grams of powder contains the equivalent of 94.6 grams 
sulfadimethoxine as sulfadimethoxine sodium.
    (b) Sponsors. See sponsor numbers in Sec. 510.600(c) of this 
chapter:
    (1) Nos. 016592, 054771, 054925, and 069043 for use of the product 
described in paragraph (a)(1) of this section.
    (2) Nos. 016592, 054771, 054925, 058829, 061133, and 066104 for use 
of the product described in paragraph (a)(2) of this section.
    (c) Related tolerances. See Sec. 556.640 of this chapter.
    (d) Conditions of use--(1) Broiler and replacement chickens--(i) 
Amount. Administer 1.875 grams per gallon (0.05 percent) of drinking 
water for 6 consecutive days.
    (ii) Indications for use. For treatment of outbreaks of coccidiosis, 
fowl cholera, and infectious coryza.
    (iii) Limitations. Withdraw 5 days before slaughter. Federal law 
restricts this drug to use by or on the order of a licensed 
veterinarian.
    (2) Turkeys--(i) Amount. Administer 0.938 grams per gallon (0.025 
percent) of drinking water for 6 consecutive days.
    (ii) Indications for use. Growing turkeys: For treatment of disease 
outbreaks of coccidiosis and fowl cholera.

[[Page 245]]

    (iii) Limitations. Withdraw 5 days before slaughter. Federal law 
restricts this drug to use by or on the order of a licensed 
veterinarian.
    (3) Cattle--(i) Amount. 1.18 to 2.36 grams per gallon (0.031 to 
0.062 percent) of drinking water. As a drench, administer 2.5 grams per 
100 pounds of body weight for first day, then 1.25 grams per 100 pounds 
of body weight per day for the next 4 consecutive days. If no 
improvement within 2 to 3 days, reevaluate diagnosis. Do not treat 
beyond 5 days.
    (ii) Indications for use. Dairy calves, dairy heifers, and beef 
cattle: For the treatment of shipping fever complex and bacterial 
pneumonia associated with Pasteurella spp. sensitive to 
sulfadimethoxine; and calf diphtheria and foot rot associated with 
Fusobacterium necrophorum (Sphaerophorus necrophorus) sensitive to 
sulfadimethoxine.
    (iii) Limitations. Withdraw 7 days before slaughter. A withdrawal 
period has not been established for this product in preruminating 
calves. Do not use in calves to be processed for veal. Federal law 
restricts this drug to use by or on the order of a licensed 
veterinarian. Federal law prohibits the extralabel use of this product 
in lactating dairy cattle.

[79 FR 28829, May 20, 2014, as amended at 81 FR 22523, Apr. 18, 2016; 81 
FR 94990, Dec. 27, 2016; 83 FR 48946, Sept. 28, 2018; 84 FR 8973, Mar. 
13, 2019]



Sec. 520.2220b  Sulfadimethoxine suspension.

    (a) Specifications. Each milliliter of suspension contains 50 
milligrams (mg) sulfadimethoxine.
    (b) Sponsors. See Nos. 000061 and 054771 in Sec. 510.600(c) of this 
chapter.
    (c) Conditions of use in dogs and cats--(1) Amount. Administer 
orally 25 mg per pound of body weight, followed by 12.5 mg per pound of 
body weight daily.
    (2) Indications for use. For the treatment of sulfonamide 
susceptible bacterial infections in dogs and cats and enteritis 
associated with coccidiosis in dogs.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[79 FR 28829, May 20, 2014]



Sec. 520.2220c  Sulfadimethoxine tablet.

    (a) Specifications. Each tablet contains 125, 250, or 500 milligrams 
(mg) sulfadimethoxine.
    (b) Sponsors. See Nos. 000061 and 054771 in Sec. 510.600(c) of this 
chapter.
    (c) [Reserved]
    (d) Conditions of use in dogs and cats--(1) Amount. Administer 25 
milligrams (mg) per pound of body weight on the first day followed by 
12.5 milligrams (mg) per pound of body weight per day until the animal 
is free of symptoms for 48 hours.
    (2) Indications for use. Treatment of sulfadimethoxine-susceptible 
bacterial infections.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[79 FR 28829, May 20, 2014]



Sec. 520.2220d  Sulfadimethoxine bolus.

    (a) Specifications. Each bolus contains 2.5, 5, or 15 grams 
sulfadimethoxine.
    (b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
    (c) Related tolerances. See Sec. 556.640 of this chapter.
    (d) Conditions of use in cattle--(1) Amount. Administer 2.5 grams 
per 100 pounds body weight for 1 day followed by 1.25 grams per 100 
pounds body weight per day; treat for 4 to 5 days.
    (2) Indications for use. For the treatment of shipping fever complex 
and bacterial pneumonia associated with Pasteurella spp. sensitive to 
sulfadimethoxine; and calf diphtheria and foot rot associated with 
Fusobacterium necrophorum sensitive to sulfadimethoxine.
    (3) Limitations. Do not administer within 7 days of slaughter; milk 
that has been taken from animals during treatment and 60 hours (5 
milkings) after the latest treatment must not be used for food. A 
withdrawal period has not been established for this product in 
preruminating calves. Do not use in calves to be processed for veal.

[79 FR 28829, May 20, 2014]



Sec. 520.2220e  Sulfadimethoxine extended-release bolus.

    (a) Specifications. Each extended-release bolus contains 12.5 grams 
sulfadimethoxine.

[[Page 246]]

    (b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
    (c) Related tolerances. See Sec. 556.640 of this chapter.
    (d) Conditions of use in beef cattle and non-lactating dairy 
cattle--(1) Amount. Administer one 12.5-gram-sustained-release bolus for 
the nearest 200 pounds of body weight, i.e., 62.5 milligrams per pound 
of body weight. Do not repeat treatment for 7 days.
    (2) Indications for use. For the treatment of shipping fever complex 
and bacterial pneumonia associated with Pasteurella spp. sensitive to 
sulfadimethoxine; and calf diphtheria and foot rot associated with 
Fusobacterium necrophorum sensitive to sulfadimethoxine.
    (3) Limitations. Do not use in female dairy cattle 20 months of age 
or older. Do not administer within 12 days of slaughter. Federal law 
restricts this drug to use by or on the order of a licensed 
veterinarian.

[79 FR 28830, May 20, 2014]



Sec. 520.2220f  Sulfadimethoxine and ormetoprim tablet.

    (a) Specifications. Each tablet contains 120 milligrams (mg) (100 mg 
sulfadimethoxine and 20 mg ormetoprim), 240 mg (200 mg sulfadimethoxine 
and 40 mg ormetoprim), 600 mg (500 mg sulfadimethoxine and 100 mg 
ormetoprim), or 1200 mg (1000 mg sulfadimethoxine and 200 mg 
ormetoprim).
    (b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in dogs--(1) Amount. On the first day of 
treatment, administer 25 mg per pound (55 mg per kilogram) of body 
weight. Then follow with a daily dosage of 12.5 mg per pound (27.5 mg 
per kilogram) of body weight. Do not exceed a total of 21 consecutive 
days.
    (2) Indications of use. Treatment of skin and soft tissue infections 
(wounds and abscesses) in dogs caused by strains of Staphylococcus 
aureus and Escherichia coli and urinary tract infections caused by E. 
coli, Staphylococcus spp., and Proteus mirabilus susceptible to 
ormetoprim-potentiated sulfadimethoxine.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[79 FR 28830, May 20, 2014]



Sec. 520.2240  Sulfaethoxypyridazine.



Sec. 520.2240a  Sulfaethoxypyridazine solution.

    (a) Specifications. Each milliliter of solution contains 62.5 
milligrams (mg) sodium sulfaethoxypyridazine.
    (b) Sponsor. See No. 054771 Sec. 510.600(c) of this chapter.
    (c) Related tolerances. See Sec. 556.650 of this chapter.
    (d) Conditions of use--(1) Swine--(i) Amount. Administer 3.8 grams 
per gallon for first day followed by 1.9 grams per gallon for not less 
than 3 days nor more than 9 days. Use as the sole source of sulfonamide.
    (ii) Indications for use. For treatment of bacterial scours 
pneumonia enteritis, bronchitis, septicemia accompanying Salmonella 
choleraesuis infection.
    (iii) Limitations. Do not treat within 10 days of slaughter. Federal 
law restricts this drug to use by or on the order of a licensed 
veterinarian.
    (2) Cattle--(i) Amount. For use at 2.5 grams per gallon. Administer 
at the rate of 1 gallon per 100 pounds of body weight per day for 4 
days. Use as the sole source of sulfonamide.
    (ii) Indications for use. For treatment of respiratory infections 
(pneumonia, shipping fever), foot rot, calf scours; and as adjunctive 
therapy in septicemia accompanying mastitis and metritis.
    (iii) Limitations. Do not treat within 16 days of slaughter. Milk 
that has been taken from animals during treatment and for 72 hours (6 
milkings) after latest treatment must not be used for food. Federal law 
restricts this drug to use by or on the order of a licensed 
veterinarian.

[79 FR 28830, May 20, 2014]



Sec. 520.2240b  Sulfaethoxypyridazine tablets.

    (a) Specifications. (1) Each tablet contains 2.5 or 15 grams 
sulfaethoxypyridazine.
    (2) Each extended-release tablet contains 5 grams 
sulfaethoxypyridazine.

[[Page 247]]

    (b) Sponsor. See No. 054771 Sec. 510.600(c) of this chapter.
    (c) Related tolerances. See Sec. 556.650 of this chapter.
    (d) Conditions of use in cattle--(1) 2.5- or 15-gram tablets--(i) 
Amount. Administer 25 milligrams per pound of body weight per day for 4 
days. Use as the sole source of sulfonamide.
    (ii) Indications for use. For treatment of respiratory infections 
(pneumonia, shipping fever), foot rot, calf scours; as adjunctive 
therapy in septicemia accompanying mastitis and metritis.
    (iii) Limitations. Do not treat within 16 days of slaughter. Milk 
that has been taken from animals during treatment and for 72 hours (6 
milkings) after latest treatment must not be used for food. Federal law 
restricts this drug to use by or on the order of a licensed 
veterinarian.
    (2) 15-gram extended-release tablets--(i) Amount. Administer 100 
milligrams per pound of body weight. Use as the sole source of 
sulfonamide.
    (ii) Indications for use. For treatment of foot rot and respiratory 
infections (shipping fever and pneumonia) caused by sulfonamide-
susceptible pathogens (E. coli, Streptococci, Staphylococci, 
Sphaerophorus necrophorus and Gram-negative rods including Pasteurella); 
and for use prophylactically during periods of stress for reducing 
losses due to sulfonamide sensitive disease conditions.
    (iii) Limitations. Do not treat within 16 days of slaughter. Not for 
use in lactating dairy cows. Federal law restricts this drug to use by 
or on the order of a licensed veterinarian.

[79 FR 28830, May 20, 2014]



Sec. 520.2260  Sulfamethazine oral dosage forms.



Sec. 520.2260a  Sulfamethazine oblet, tablet, and bolus.

    (a)(1) Sponsor. See No. 016592 in Sec. 510.600(c) of this chapter 
for use of 2.5-, 5-, and 15-gram sulfamethazine oblet in beef cattle, 
nonlactating dairy cattle, and horses. See No. 061690 in Sec. 
510.600(c) of this chapter for use of 5-, 15-, and 25-gram tablet in 
beef and nonlactating dairy cattle.
    (2) Related tolerance in edible products. See Sec. 556.670 of this 
chapter.
    (3) Conditions of use--(i) Amount. Administer as a single dose 100 
milligrams of sulfamethazine per pound of body weight the first day and 
50 milligrams per pound of body weight on each following day.
    (ii) Indications for use. For treatment of diseases caused by 
organisms susceptible to sulfamethazine.
    (A) Beef cattle and nonlactating dairy cattle. Treatment of 
bacterial pneumonia and bovine respiratory disease complex (shipping 
fever complex) (Pasteurella spp.), colibacillosis (bacterial scours) 
(Escherichia coli), necrotic pododermatitis (foot rot) (Fusobacterium 
necrophorum), calf diphtheria (Fusobacterium necrophorum), acute 
mastitis (Streptococcus spp.), acute metritis (Streptococcus spp.), 
coccidiosis (Eimeria bovis and Eimeria zurnii).
    (B) Horses. Treatment of bacterial pneumonia (secondary infections 
associated with Pasteurella spp.), strangles (Streptococcus equi), and 
bacterial enteritis (Escherichia coli).
    (iii) Limitations. Administer daily until animal's temperature and 
appearance are normal. If symptoms persist after using for 2 or 3 days 
consult a veterinarian. Fluid intake must be adequate. Treatment should 
continue 24 to 48 hours beyond the remission of disease symptoms, but 
not to exceed 5 consecutive days. Follow dosages carefully. Do not treat 
cattle within 10 days of slaughter. Do not use in female dairy cattle 20 
months of age or older. Use of sulfamethazine in this class of cattle 
may cause milk residues. A withdrawal period has not been established in 
preruminating calves. Do not use in calves to be processed for veal. Do 
not use in horses intended for human consumption.
    (b)(1) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter 
for use of 5-gram sulfamethazine bolus.
    (2) Related tolerances in edible products. See Sec. 556.670 of this 
chapter.
    (3) Conditions of use--(i) Amount. Administer 10 grams (2 boluses) 
of sulfamethazine per 100 pounds of body weight the first day, then 5 
grams (1 bolus) of sulfamethazine per 100 pounds of body weight daily 
for up to 4 additional consecutive days.

[[Page 248]]

    (ii) Indications for use. Ruminating beef and dairy calves. For 
treatment of the following diseases caused by organisms susceptible to 
sulfamethazine: bacterial scours (colibacilloosis) caused by E. coli; 
necrotic pododermatitis (foot rot) and calf diphtheria caused by F. 
necrophorum; bacterial pneumonia associated with Pasteurella spp.; and 
coccidiosis caused by E. bovis and E. zurnii.
    (iii) Limitations. Do not administer for more than 5 consecutive 
days. Do not treat calves within 11 days of slaughter. Do not use in 
calves to be slaughtered under 1 month of age or in calves being fed an 
all milk diet. Do not use in female dairy cattle 20 months of age or 
older; such use may cause drug residues in milk. Administer with 
adequate supervision. Follows recomended dosages carefully. Fluid intake 
must be adequate. If symptoms persist after 2 or 3 days, consult a 
veterinarian.

[54 FR 15751, Apr. 19, 1989; 54 FR 19283, May 4, 1989, as amended at 56 
FR 50653, Oct. 8, 1991; 59 FR 22754, May 3, 1994; 61 FR 4875, Feb. 9, 
1996; 64 FR 66383, Nov. 26, 1999; 67 FR 78355, Dec. 24, 2002; 75 FR 
10166, Mar. 5, 2010; 76 FR 17337, Mar. 29, 2011; 79 FR 28830, May 20, 
2014; 81 FR 17607, Mar. 30, 2016]



Sec. 520.2260b  Sulfamethazine sustained-release boluses.

    (a) Related tolerances. See Sec. 556.670 of this chapter.
    (b) 22.5-gram bolus--(1) Sponsor. See No. 058198 in Sec. 510.600(c) 
of this chapter for use of a 22.5-gram sulfamethazine prolonged-release 
bolus.
    (2) Conditions of use--(i) Amount. Depending on the duration of 
therapeutic levels desired, administer boluses as a single dose as 
follows: 3\1/2\ days--1 bolus (22.5 grams) per 200 pounds of body 
weight; 5 days--1 bolus per 100 pounds of body weight.
    (ii) Indications for use. Beef and nonlactating cattle for sustained 
treatment of shipping fever pneumonia caused or complicated by 
Pasteurella multocida; as an aid in the treatment of foot rot, mastitis, 
pneumonia, metritis, bacterial enteritis, calf diphtheria, and 
septicemia when caused or complicated by bacteria susceptible to 
sulfamethazine.
    (iii) Limitations. Cattle that are acutely ill should be treated 
parenterally with a suitable antibacterial product to obtain immediate 
therapeutic blood levels; do not slaughter animals for food within 16 
days of treatment; do not use in lactating dairy cattle; Federal law 
restricts this drug to use by or on the order of a licensed 
veterinarian.
    (c)(1) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter 
for use of a 27-gram sulfamethazine sustained-release bolus.
    (2) Conditions of use--(i) Amount. 27 grams (1 bolus) for each 150 
pounds of body weight as a single dose.
    (ii) Indications for use. For nonlactating cattle for the treatment 
of infections caused by organisms sensitive to sulfamethazine such as 
hemorrhagic septicemia (shipping fever complex), bacterial pneumonia, 
foot rot, and calf diphtheria and as an aid in the control of bacterial 
diseases usually associated with shipping and handling of cattle.
    (iii) Limitations. If no response within 2 to 3 days, reevaluate 
therapy; do not crush tablets; treated animals must not be slaughtered 
for food within 28 days after the latest treatment; Federal law 
restricts this drug to use by or on the order of a licensed 
veterinarian.
    (d)(1) Sponsor. See No. 061133 in Sec. 510.600(c) of this chapter 
for use of a 32.1-gram sustained-release bolus.
    (2) Conditions of use--(i) Amount. 32.1 grams (1 bolus) per 200 
pounds of body weight.
    (ii) Indications for use. For beef and nonlactating dairy cattle for 
the treatment of diseases caused by sulfamethazine-sensitive organisms 
as follows: bacterial pneumonia and bovine respiratory disease complex 
(shipping fever complex) caused by Pasteurella spp., colibacillosis 
(bacterial scours) caused by E. coli, necrotic pododermatitis (foot rot) 
and calf diphtheria caused by Fusobacterium necrophorum, and acute 
mastitis and acute metritis caused by Streptococcus spp.)
    (iii) Limitations. After 72 hours, all animals should be reexamined 
for persistence of observable disease signs. If signs are present, 
consult a veterinarian. It is strongly recommended that a second dose be 
given to provide for an additional 72 hours of therapy, particularly in 
more severe cases. The

[[Page 249]]

dosage schedule should be used at each 72-hour interval. Animals should 
not receive more than 2 doses because of the possibility of incurring 
residue violations. This drug, like all sulfonamides, may cause toxic 
reactions and irreparable injury unless administered with adequate and 
continuous supervision; follow dosages carefully. Fluid intake must be 
adequate at all times throughout the 3-day therapy, Do not use in female 
dairy cattle 20 months of age or older. Use of sulfamethazine in this 
class of cattle may cause milk residues. Do not treat animals within 12 
days of slaughter.
    (e) 22.5-gram bolus--(1) Sponsor. See No. 058198 in Sec. 510.600(c) 
of this chapter for use of a 22.5-gram sulfamethazine sustained release 
bolus.
    (2) Conditions of use--(i) Amount. Administer 1 bolus (22.5 grams) 
per 200 pounds of body weight, as a single dose.
    (ii) Indications for use. Beef and nonlactating dairy cattle for the 
prolonged treatment of the following diseases when caused by one or more 
of the listed pathogenic organisms sensitive to sulfamethazine: bovine 
respiratory disease complex (shipping fever complex) (Pasteurella spp.), 
bacterial pneumonia (Pasteurella spp.), necrotic pododermatitis (foot 
rot) (Fusobacterium necrophorum), colibacillosis (bacterial scours) 
(Escherichia coli), calf diphtheria (Fusobacterium necrophorum), acute 
mastitis (Streptococcus spp.) and acute metritis (Streptococcus spp.).
    (iii) Limitations. Cattle that are acutely ill should be treated by 
injection with a suitable antibacterial product to obtain immediate 
therapeutic blood levels; do not slaughter animals for food within 16 
days of treatment; do not use in lactating dairy cattle; if treated 
animals do not respond within 2 to 3 days, consult a veterinarian.
    (f)(1) Sponsor. See No. 061133 in Sec. 510.600(c) of this chapter 
for use of an 8.02-gram sulfamethazine sustained-release bolus.
    (2) Conditions of use--(i) Amount. Administer 2 boluses (8.02 grams 
per bolus) per 100 pounds of body weight, as a single dose.
    (ii) Indications for use. Administer orally to ruminating calves for 
the prolonged treatment of the following diseases when caused by one or 
more of the listed pathogenic organisms sensitive to sulfamethazine: 
bacterial pneumonia (Pasteurella spp.), colibacillosis (bacterial 
scours) (E. coli), and calf diptheria (Fusobacterium necrophorum).
    (iii) Limitations. For use in ruminating replacement calves only; 72 
hours after dosing all animals should be reexamined for persistence of 
disease signs; if signs are present, consult a veterinarian; do not 
slaughter animals for food for at least 12 days after the last dose; 
this product has not been shown to be effective for nonruminating 
calves; exceeding two consecutive doses may cause violative tissue 
residue to remain beyond the withdrawal time; do not use in calves under 
1 month of age or calves being fed an all milk diet.
    (g)(1) Sponsor. See No. 016592 in Sec. 510.600(c) of this chapter 
for use of a 30-gram sulfamethazine sustained-release bolus.
    (2) Conditions of use--(i) Amount. Administer at the rate of 1 bolus 
(30 grams per bolus) per 200 pounds of body weight, as a single dose.
    (ii) Indications for use. Administer orally to beef cattle and 
nonlactating dairy cattle for the treatment of the following diseases 
when caused by one or more of the listed pathogenic organisms sensitive 
to sulfamethazine: bovine respiratory disease complex (shipping fever 
complex) associated with Pasteurella spp.; bacterial pneumonia 
associated with Pasteurell spp.; necrotic pododermatitis (foot rot) and 
calf diphtheria caused by Fusobacterium necrophorum; colibacillosis 
(bacterial scours) caused by Escherichia coli; coccidiosis caused by 
Eimeria bovis and E. zurnii; acute mastitis and metritis caused by 
Streptococcus spp.
    (iii) Limitations. For use in beef cattle and nonlactating dairy 
cattle only; if symptoms persist for 2 or 3 days after use, consult a 
veterinarian; do not slaughter animals for food for at least 8 days 
after the last dose; do not use in lactating dairy cattle; do not 
administer more than two consecutive doses.
    (h)(1) Sponsor. See No. 000010 in Sec. 510.600(c) of this chapter 
for use of an 8.25-gram sulfamethazine sustained-release bolus.

[[Page 250]]

    (2) Conditions of use--(i) Amount. Administer at the rate of 1 bolus 
(8.25 grams per bolus) per 50 pounds of body weight, as a single dose. 
If signs of disease are significantly reduced, it is recommended that a 
second dose be given to provide an additional 72 hours of therapy.
    (ii) Indications for use. Administer orally to ruminating beef and 
dairy calves for treatment of the following diseases when caused by one 
or more of the listed pathogenic organisms susceptible to 
sulfamethazine: bacterial pneumonia associated with Pasteurella spp.; 
colibacillosis (bacterial scours) caused by Escherichia coli; 
coccidiosis caused by Eimeria bovis and E. zurnii; and calf diphtheria 
caused by Fusobacterium necrophorum.
    (iii) Limitations. Do not use in calves to be slaughtered under 1 
month of age or calves being fed an all milk diet. Do not use in female 
dairy cattle 20 months of age or older. If symptoms persist after 3 
days, consult a veterinarian. Do not administer more than 2 consecutive 
doses. Do not slaughter animals for food for at least 8 days after the 
last dose. Do not crush bolus.

[46 FR 36132, July 14, 1981, as amended at 48 FR 18803, Apr. 26, 1983; 
48 FR 32760, July 19, 1983; 49 FR 29057, July 18, 1984; 50 FR 49372, 
Dec. 2, 1985; 51 FR 30212, Aug. 25, 1986; 53 FR 40727, Oct. 18, 1988; 54 
FR 14341, Apr. 11, 1989; 55 FR 8462, Mar. 8, 1990; 56 FR 50653, Oct. 8, 
1991; 59 FR 22754, May 3, 1994; 61 FR 4875, Feb. 9, 1996; 62 FR 35076, 
June 30, 1997; 66 FR 14073, Mar. 9, 2001; 68 FR 4915, Jan. 31, 2003; 70 
FR 8290, Feb. 18, 2005; 78 FR 17596, Mar. 22, 2013; 79 FR 28830, May 20, 
2014; 81 FR 22523, Apr. 18, 2016; 84 FR 8973, Mar. 13, 2019; 85 FR 
18119, Apr. 1, 2020; 86 FR 14819, Mar. 19, 2021]



Sec. 520.2260c  Sulfamethazine sustained-release tablets.

    (a) Specifications. Each extended-release tablet contains 8 grams 
sulfamethazine.
    (b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
    (c) Related tolerances. See Sec. 556.670 of this chapter.
    (d) Conditions of use--(1) Amount. 8 grams (1 tablet) per 45 pounds 
of body weight as a single dose.
    (2) Indications for use. In calves for sustained treatment of 
pneumonia caused by Pasteurella spp., colibacillosis (bacterial scours) 
caused by Escherichia coli; and calf diptheria caused by Fusobacterium 
necrophorum.
    (3) Limitations. Treated animals must not be slaughtered for food 
within 18 days after the latest treatment. Federal law restricts this 
drug to use by or on the order of a licensed veterinarian.

[48 FR 26763, June 10, 1983, as amended at 56 FR 50653, Oct. 8, 1991; 59 
FR 22754, May 3, 1994; 61 FR 4875, Feb. 9, 1996; 79 FR 28830, May 20, 
2014]



Sec. 520.2261  Sulfamethazine sodium oral dosage forms.



Sec. 520.2261a  Sulfamethazine solution.

    (a) Specifications. Each milliliter of solution contains 125 
milligrams (12.5 percent) sulfamethazine sodium.
    (b) Sponsors. See No. 016592 in Sec. 510.600(c) of this chapter.
    (c) Related tolerances. See Sec. 556.670 of this chapter.
    (d) Conditions of use--(1) Amount. Administer in drinking water to 
provide: Cattle and swine 112.5 milligrams of sulfamethazine sodium per 
pound of body weight per day on the first day and 56.25 milligrams per 
pound of body weight on subsequent days; Chickens, 61 to 89 milligrams 
of sulfamethazine sodium per pound of body weight per day, and turkeys 
53 to 130 milligrams of sulfamethazine sodium per pound of body weight 
per day, depending upon the dosage, age, and class of chickens or 
turkeys, ambient temperature, and other factors.
    (2) Indications for use. For treatment and control of diseases 
caused by organisms sensitive to sulfamethazine.
    (i) Beef and nonlactating dairy cattle. Treatment of bacterial 
pneumonia and bovine respiratory disease complex (shipping fever 
complex) (Pasteurella spp.), colibacillosis (bacterial scours) 
(Escherichia coli), necrotic pododermatitis (foot rot) (Fusobacterium 
necrophorum), calf diphtheria (Fusobacterium necrophorum), acute 
mastitis (Streptococcus spp.), and acute metritis (Streptococcus spp.).
    (ii) Swine. Treatment of porcine colibacillosis (bacterial scours) 
(Escherichia coli), and bacterial pneumonia (Pasteurella spp.).
    (iii) Chickens and turkeys. In chickens for control of infectious 
coryza

[[Page 251]]

(Avibacterium paragallinarum), coccidiosis (Eimeria tenella, Eimeria 
necatrix), acute fowl cholera (Pasteurella multocida), and pullorum 
disease (Salmonella Pullorum). In turkeys for control of coccidiosis 
(Eimeria meleagrimitis, Eimeria adenoeides). Medicate as follows: 
Infectious coryza in chickens, medicate for 2 consecutive days; acute 
fowl cholera and pullorum disease, in chickens, medicate for 6 
consecutive days; coccidiosis, in chickens and turkeys, medicate as in 
paragraph (c) of this section, then reduce amount of medication to one-
half for 4 additional days.
    (3) Limitations. Add the required dose to that amount of water that 
will be consumed in 1 day. Consumption should be carefully checked. Have 
only medicated water available during treatment. Withdraw medication 
from cattle, chickens, and turkeys 10 days prior to slaughter for food. 
Withdraw medication from swine 15 days before slaughter for food. Do not 
medicate chickens or turkeys producing eggs for human consumption. 
Treatment of all diseases should be instituted early. Treatment should 
continue 24 to 48 hours beyond the remission of disease symptoms, but 
not to exceed a total of 5 consecutive days in cattle or swine. 
Medicated cattle, swine, chickens, and turkeys must actually consume 
enough medicated water which provides the recommended dosages. Do not 
use in female dairy cattle 20 months of age or older. Use of 
sulfamethazine in this class of cattle may cause milk residues. A 
withdrawal period has not been established in preruminating calves. Do 
not use in calves to be processed for veal. Federal law restricts this 
drug to use by or on the order of a licensed veterinarian.

[47 FR 25322, June 11, 1982, as amended at 47 FR 25735, June 15, 1982; 
67 FR 78355, Dec. 24, 2002; 70 FR 32489, June 3, 2005; 74 FR 36112, July 
22, 2009; 75 FR 10166, Mar. 5, 2010; 76 FR 17337, Mar. 29, 2011; 79 FR 
28831, May 20, 2014; 81 FR 17607, Mar. 30, 2016; 81 FR 36789, June 8, 
2016; 81 FR 94990, Dec. 27, 2016]



Sec. 520.2261b  Sulfamethazine powder.

    (a) Specifications. A soluble powder composed of 100 percent 
sulfamethazine sodium.
    (b) Sponsors. See Nos. 016592 and 061133 in Sec. 510.600(c) of this 
chapter.
    (c) Related tolerances. See Sec. 556.670 of this chapter.
    (d) Conditions of use--(1) Chickens--(i) Amount. Administer in 
drinking water to provide 58 to 85 milligrams (mg) per pound (/lb) of 
body weight per day.
    (ii) Indications for use. For control of infectious coryza 
(Avibacterium paragallinarum), coccidiosis (Eimeria tenella, E. 
necatrix), acute fowl cholera (Pasteurella multocida), and pullorum 
disease (Salmonella Pullorum).
    (iii) Limitations. Add the required dose to that amount of water 
that will be consumed in 1 day. Consumption should be carefully checked. 
Have only medicated water available during treatment. Withdraw 
medication 10 days prior to slaughter for food. Do not medicate chickens 
producing eggs for human consumption. Treatment of all diseases should 
be instituted early. Treatment should continue 24 to 48 hours beyond the 
remission of disease symptoms. Medicated chickens must actually consume 
enough medicated water which provides the recommended dosages. Federal 
law restricts this drug to use by or on the order of a licensed 
veterinarian.
    (2) Turkeys--(i) Amount. Administer in drinking water to provide 50 
to 124 mg/lb of body weight per day
    (ii) Indications for use. For control of coccidiosis (E. 
meleagrimitis, E. adenoeides).
    (iii) Limitations. Add the required dose to that amount of water 
that will be consumed in 1 day. Consumption should be carefully checked. 
Have only medicated water available during treatment. Withdraw 
medication 10 days prior to slaughter for food. Do not medicate turkeys 
producing eggs for human consumption. Treatment of all diseases should 
be instituted early. Treatment should continue 24 to 48 hours beyond the 
remission of disease symptoms. Medicated turkeys must actually consume 
enough medicated water which provides the recommended dosages. Federal 
law restricts this drug to use by or on the order of a licensed 
veterinarian.
    (3) Swine--(i) Amount. Administer in drinking water, or as a drench, 
to provide 108 mg/lb of body weight on the

[[Page 252]]

first day and 54 mg/lb of body weight per day on the second, third, and 
fourth days of administration.
    (ii) Indications for use. For treatment of porcine colibacillosis 
(bacterial scours) (E. coli), and bacterial pneumonia (Pasteurella 
spp.).
    (iii) Limitations. Add the required dose to that amount of water 
that will be consumed in 1 day. Consumption should be carefully checked. 
Have only medicated water available during treatment. Withdraw 
medication 15 days prior to slaughter for food. Treatment of all 
diseases should be instituted early. Treatment should continue 24 to 48 
hours beyond the remission of disease symptoms, but not to exceed a 
total of 5 consecutive days. Medicated swine must actually consume 
enough medicated water which provides the recommended dosages. Federal 
law restricts this drug to use by or on the order of a licensed 
veterinarian.
    (4) Cattle--(i) Amount. Administer in drinking water, or as a 
drench, to provide 108 mg/lb of body weight on the first day and 54 mg/
lb of body weight per day on the second, third, and fourth days of 
administration.
    (ii) Indications for use in beef and nonlactating dairy cattle. 
Treatment of bacterial pneumonia and bovine respiratory disease complex 
(shipping fever complex) (Pasteurella spp.), colibacillosis (bacterial 
scours) (E. coli), necrotic pododermatitis (foot rot) (Fusobacterium 
necrophorum), calf diphtheria (F. necrophorum), acute mastitis 
(Streptococcus spp.), and acute metritis (Streptococcus spp.)
    (iii) Limitations. Add the required dose to that amount of water 
that will be consumed in 1 day. Consumption should be carefully checked. 
Have only medicated water available during treatment. Withdraw 
medication 10 days prior to slaughter for food. Treatment of all 
diseases should be instituted early. Treatment should continue 24 to 48 
hours beyond the remission of disease symptoms, but not to exceed a 
total of 5 consecutive days. Medicated cattle must actually consume 
enough medicated water which provides the recommended dosages. Do not 
use in female dairy cattle 20 months of age or older. Use of 
sulfamethazine in this class of cattle may cause milk residues. Do not 
use in calves under one (1) month of age or calves being fed an all-milk 
diet. Use in these classes of calves may cause violative residues to 
remain beyond the withdrawal time. Federal law restricts this drug to 
use by or on the order of a licensed veterinarian.

[71 FR 70303, Dec. 4, 2006, as amended at 75 FR 10166, Mar. 5, 2010; 79 
FR 28831, May 20, 2014; 80 FR 61296, Oct. 13, 2015; 81 FR 17607, Mar. 
30, 2016; 81 FR 94990, Dec. 27, 2016; 84 FR 8973, Mar. 13, 2019]



Sec. 520.2280  Sulfamethizole and methenamine.

    (a) Specifications. Each tablet contains 250 milligrams of 
sulfamethizole and 250 milligrams of methenamine mandelate.
    (b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in dogs and cats--(1) Amount. Administer 
orally 1 tablet per 20 pounds of body weight 3 times per day until 
clinical signs are alleviated. To reduce the possibility of relapse, 
continue therapy for a week to 10 days.
    (2) Indications for use. For treatment of urinary tract infections 
such as cystitis, nephritis, prostatitis, urethritis, and 
pyelonephritis. As an aid in the management of complications resulting 
from surgical manipulations of the urinary tract such as removal of 
calculi from the bladder, in ureterostomies, and in instrumentation of 
the urethra and bladder.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[40 FR 13838, Mar. 27, 1975, as amended at 50 FR 13561, Apr. 5, 1985; 79 
FR 28831, May 20, 2014]



Sec. 520.2325  Sulfaquinoxaline oral dosage forms.



Sec. 520.2325a  Sulfaquinoxaline powder and solution.

    (a) Sponsor. See Sec. 510.600(c) of this chapter for identification 
of the sponsors.
    (1) To No. 016592 for use of a 25-percent sulfaquinoxaline soluble 
powder

[[Page 253]]

and a 20-percent sulfaquinoxaline sodium solution as provided for in 
paragraph (c) of this section.
    (2) To Nos. 016592 and 054771 for use of a 31.92-percent 
sulfaquinoxaline solution (sodium and potassium salts) as provided for 
in paragraphs (c)(1), (c)(2), (c)(3), (c)(4)(i), and (c)(4)(ii) of this 
section.
    (3) No. 054771 for use of a 28.62-percent sulfaquinoxaline sodium 
solution as provided in paragraphs (c)(1), (c)(2), and (c)(3) of this 
section.
    (b) Related tolerances. See Sec. 556.685 of this chapter.
    (c) Conditions of use. It is used in drinking water as follows:
    (1) Chickens. (i) As an aid in the control of outbreaks of 
coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. 
maxima, and E. brunetti.
    (ii) Administer at the 0.04 percent level for 2 or 3 days, skip 3 
days then administer at the 0.025 percent level for 2 more days. If 
bloody droppings appear, repeat treatment at the 0.025 percent level for 
2 more days. Do not change litter unless absolutely necessary. Do not 
give flushing mashes.
    (2) Turkeys. (i) As an aid in the control of outbreaks of 
coccidiosis caused by Eimeria meleagrimitis and E. adenoeides.
    (ii) Administer at the 0.025 percent level for 2 days, skip 3 days, 
give for 2 days, skip 3 days and give for 2 more days. Repeat if 
necessary. Do not change litter unless absolutely necessary. Do not give 
flushing mashes.
    (3) Chickens and turkeys. (i) As an aid in the control of acute fowl 
cholera caused by Pasteurella multocida susceptible to sulfaquinoxaline 
and fowl typhoid caused by Salmonella gallinarum susceptible to 
sulfaquinoxaline.
    (ii) Administer at the 0.04 percent level for 2 or 3 days. Move 
birds to clean ground. If disease recurs, repeat treatment. If cholera 
has become established as the respiratory or chronic form, use feed 
medicated with sulfaquinoxaline. Poultry which have survived typhoid 
outbreaks should not be kept for laying house replacements or breeders 
unless tests show they are not carriers.
    (4) Cattle and calves. (i) For the control and treatment of 
outbreaks of coccidiosis caused by Eimeria bovis or E. zurnii.
    (ii) Administer at the 0.015-percent level for 3 to 5 days in 
drinking water medicated with sulfaquinoxaline solution.
    (iii) In lieu of treatment as provided in paragraph (e)(4)(ii) of 
this section, administer 1 teaspoon of 25-percent sulfaquinoxaline 
soluble powder per day for each 125 pounds of body weight for 3 to 5 
days in drinking water.
    (d) Limitations. May cause toxic reactions unless the drug is evenly 
mixed in water at dosages indicated and used according to directions. 
For control of outbreaks of disease, medication should be initiated as 
soon as the diagnosis is determined. Medicated chickens, turkeys, 
cattle, and calves must actually consume enough medicated water which 
provides a recommended dosage of approximately 10 to 45 milligrams per 
pound per day in chickens, 3.5 to 55 milligrams per pound per day in 
turkeys, and approximately 6 milligrams per pound per day in cattle and 
calves depending on the age, class of animal, ambient temperature, and 
other factors. A withdrawal period has not been established for 
sulfaquinoxaline in preruminating calves. Do not use in calves to be 
processed for veal. Not for use in lactating dairy cattle. Do not give 
to chickens, turkeys or cattle within 10 days of slaughter for food. Do 
not medicate chickens or turkeys producing eggs for human consumption. 
Make fresh drinking water daily. Federal law restricts this drug to use 
by or on the order of a licensed veterinarian.

[48 FR 3964, Jan. 28, 1983, as amended at 48 FR 26762, June 10, 1983; 55 
FR 29843, July 23, 1990; 59 FR 28769, June 3, 1994; 59 FR 33197, June 
28, 1994; 61 FR 24443, May 15, 1996; 61 FR 63711, Dec. 2, 1996; 62 FR 
37712, July 15, 1997; 65 FR 10705, Feb. 29, 2000; 69 FR 41427, July 9, 
2004; 69 FR 60547, Oct. 12, 2004; 74 FR 36112, July 22, 2009; 78 FR 
17596, Mar. 22, 2013; 79 FR 28831, May 20, 2014; 81 FR 22523, Apr. 18, 
2016; 81 FR 36789, June 8, 2016; 81 FR 59134, Aug. 29, 2016; 81 FR 
94990, Dec. 27, 2016]



Sec. 520.2325b  Sulfaquinoxaline drench.

    (a) Specifications. A soluble powder containing 25 percent 
sulfaquinoxaline.
    (b) Sponsor. See No. 016592 in Sec. 510.600(c) of this chapter.

[[Page 254]]

    (c) Related tolerances. See Sec. 556.685 of this chapter.
    (d) Conditions of use in cattle--(1) Amount. Administer 1 teaspoon 
of 25 percent sulfaquinoxaline soluble powder for each 125 pounds of 
body weight for 3 to 5 days as a drench.
    (2) Indications for use. For the control and treatment of outbreaks 
of coccidiosis in cattle and calves caused by Eimeria bovis or E. 
zuernii.
    (3) Limitations. Not for use in lactating dairy cattle. A withdrawal 
period has not been established for this product in preruminating 
calves. Do not use in calves to be processed for veal. Federal law 
restricts this drug to use by or on the order of a licensed 
veterinarian.

[79 FR 28831, May 20, 2014, as amended at 82 FR 12169, Mar. 1, 2017; 84 
FR 32992, July 11, 2019; 84 FR 53310, Oct. 7, 2019]



Sec. 520.2330  Sulfisoxazole tablets.

    (a) Specifications. Each tablet contains 260 milligrams (4 grains) 
of sulfisoxazole.
    (b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use--(1) Amount. Administer one tablet orally per 
4 pounds of body weight.
    (2) Indications for use. Use in dogs and cats as an aid in treatment 
of bacterial pneumonia and bacterial enteritis when caused by organisms 
sensitive to sulfisoxazole.
    (3) Limitations. Repeat dosage at 24-hour intervals until 2 to 3 
days after disappearance of clinical symptoms. (Administration of one-
half daily dosage at 12-hour intervals or one-third daily dosage at 8-
hour intervals will provide a more constant blood level.) Provide 
adequate supply of drinking water. If symptoms persist after using this 
preparation for 2 or 3 days, consult a veterinarian.

[43 FR 60895, Dec. 29, 1978, as amended at 79 FR 28831, May 20, 2014]



Sec. 520.2335  Telmisartan.

    (a) Specifications. Each milliliter of solution contains 10 
milligrams (mg) telmisartan.
    (b) Sponsor. See No. 000010 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use--(1) Amount. Administer 1.5 mg/kilogram (kg) 
(0.68 mg/pound (lb)) orally twice daily for 14 days, followed by 2 mg/kg 
(0.91 mg/lb) orally once daily.
    (2) Indications for use. For the control of systemic hypertension in 
cats.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[83 FR 64740, Dec. 18, 2018]



Sec. 520.2340  Tepoxalin.

    (a) Specifications. Each tablet contains 30, 50, 100, or 200 
milligrams (mg) tepoxalin.
    (b) Sponsor. See No. 000061 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in dogs--(1) Amount. 10 mg per kilogram (/kg) 
daily; or 20 mg/kg on the initial day of treatment, followed by 10 mg/kg 
daily.
    (2) Indications for use. For the control of pain and inflammation 
associated with osteoarthritis.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[68 FR 34795, June 11, 2003]



Sec. 520.2345  Tetracycline.



Sec. 520.2345a  Tetracycline capsules.

    (a) Specifications. Each capsule contains 50, 100, 125, 250, or 500 
milligrams (mg) tetracycline hydrochloride.
    (b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in dogs--(1) Amount. 25 mg per pound of body 
weight per day in divided doses every 6 hours.
    (2) Indications for use. For treatment of infections caused by 
organisms sensitive to tetracycline hydrochloride, such as bacterial 
gastroenteritis due to E. coli and urinary tract infections due to 
Staphylococcus spp. and E. coli.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[70 FR 50182, Aug. 26, 2005, as amended at 73 FR 18442, Apr. 4, 2008; 79 
FR 28831, May 20, 2014]



Sec. 520.2345b  Tetracycline tablets.

    (a) Specifications. Each tablet contains 100, 250, or 500 milligrams 
of tetracycline (as the hydrochloride).

[[Page 255]]

    (b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use. Dogs--(1) Amount. 25 milligrams per pound of 
body weight per day in divided doses every 6 hours.
    (2) Indications for use. Treatment of infections caused by organisms 
sensitive to tetracycline hydrochloride, such as bacterial 
gastroenteritis due to E. coli and urinary tract infections due to 
Staphylococcus spp. and E. coli.
    (3) Limitations. Administer orally; continue treatment until 
symptoms of the disease have subsided and temperature is normal for 48 
hours; not for use in animals raised for food production; Federal law 
restricts this drug to use by or on the order of a licensed 
veterinarian.

[57 FR 37327, Aug. 18, 1992, as amended at 79 FR 28831, May 20, 2014]



Sec. 520.2345c  Tetracycline boluses.

    (a) Specifications. Each bolus contains 500 milligrams of 
tetracycline (as the hydrochloride).
    (b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
    (c) Related tolerances. See Sec. 556.720 of this chapter.
    (d) Conditions of use. Calves--(1) Amount. 10 milligrams per pound 
of body weight per day in divided doses.
    (i) Indications for use. Control and treatment of bacterial 
enteritis (scours) caused by E. coli and bacterial pneumonia caused by 
Pasteurella spp., Hemophilus spp., and Klebsiella spp.
    (ii) Limitations. Administer orally for 3 to 5 days; do not 
slaughter animals for food within 14 days of treatment; use as sole 
source of tetracycline.
    (2) Amount. 10 milligrams per pound of body weight per day in two 
divided doses.
    (i) Indications for use. Treatment of bacterial pneumonia caused by 
organisms susceptible to tetracycline, bacterial enteritis caused by E. 
coli, and salmonella organisms susceptible to tetracycline.
    (ii) Limitations. Administer orally for not more than 5 days; do not 
slaughter animals for food within 12 days of treatment; use as sole 
source of tetracycline.

[57 FR 37328, Aug. 18, 1992, as amended at 67 FR 78355, Dec. 24, 2002; 
79 FR 28831, May 20, 2014; 81 FR 67151, Sept. 30, 2016]



Sec. 520.2345d  Tetracycline powder.

    (a) Specifications. Each pound of powder contains 25, 102.4, or 324 
grams tetracycline hydrochloride.
    (b) Sponsors. See sponsors listed in Sec. 510.600(c) of this 
chapter for conditions of use as in paragraph (d) of this section:
    (1) No. 054771: 25 grams per pound as in paragraphs (d)(3) and 
(d)(4) of this section.
    (2) No. 066104: 25, 102.4, and 324 grams per pound as in paragraph 
(d) of this section.
    (3) Nos. 016592 and 054771: 25, 102.4, and 324 grams per pound as in 
paragraph (d) of this section.
    (4) Nos. 016592, 054925, 061133, and 076475: 324 grams per pound as 
in paragraph (d) of this section.
    (5) No. 016592: 25 grams per pound as in paragraphs (d)(1) and 
(d)(2) of this section.
    (c) Related tolerances. See Sec. 556.720 of this chapter.
    (d) Conditions of use. It is administered in drinking water as 
follows:
    (1) Calves--(i) Amount. 10 milligrams per pound of body weight per 
day in divided doses.
    (ii) Indications for use. Control and treatment of bacterial 
enteritis (scours) caused by Escherichia coli and bacterial pneumonia 
(shipping fever complex) associated with Pasteurella spp., 
Actinobacillus pleuropneumoniae (Haemophilus spp.), and Klebsiella spp., 
susceptible to tetracycline.
    (iii) Limitations. Administer for 3 to 5 days; do not slaughter 
animals for food within 4 days of treatment for No. 066104 and within 5 
days of treatment for Nos. 016592, 054771, 054925, 057561, and 061133; 
prepare a fresh solution daily; use as the sole source of tetracycline. 
A withdrawal period has not been established for this product in 
preruminating calves. Do not use in calves to be processed for veal. 
Federal law restricts this drug to use by or on the order of a licensed 
veterinarian.

[[Page 256]]

    (2) Swine--(i) Amount. 10 milligrams per pound of body weight per 
day in divided doses.
    (ii) Indications for use. Control and treatment of bacterial 
enteritis (scours) caused by E. coli and bacterial pneumonia associated 
with Pasteurella spp., A. pleuropneumoniae (Haemophilus spp.), and 
Klebsiella spp., susceptible to tetracycline.
    (iii) Limitations. Administer for 3 to 5 days; do not slaughter 
animals for food within 7 days of treatment for No. 066104 and within 4 
days of treatment for Nos. 016592, 054771, 054925, 057561, and 061133; 
prepare a fresh solution daily; use as the sole source of tetracycline. 
Federal law restricts this drug to use by or on the order of a licensed 
veterinarian.
    (3) Chickens--(i) Amount. Chronic respiratory disease: 400 to 800 
milligrams per gallon. Infectious synovitis: 200 to 400 milligrams per 
gallon.
    (ii) Indications for use. Control of chronic respiratory disease 
(CRD or air-sac disease) caused by Mycoplasma gallisepticum and E. coli; 
control of infectious synovitis caused by M. synoviae susceptible to 
tetracycline.
    (iii) Limitations. Administer for 7 to 14 days; do not slaughter for 
food within 4 days of treatment; not for use in chickens producing eggs 
for human consumption; prepare a fresh solution daily; use as the sole 
source of tetracycline. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.
    (4) Turkeys--(i) Amount. For infectious synovitis: 400 milligrams 
per gallon. For complicating bacterial organisms associated with 
bluecomb (transmissible enteritis or coronaviral enteritis): 25 
milligrams per pound of body weight per day.
    (ii) Indications for use. Control of infectious synovitis caused by 
M. synoviae; control of bluecomb complicated by organisms sensitive to 
tetracycline.
    (iii) Limitations. Administer for 7 to 14 days; do not slaughter for 
food within 4 days of treatment; not for use in turkeys producing eggs 
for human consumption; prepare a fresh solution daily; use as the sole 
source of tetracycline. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

[59 FR 17693, Apr. 14, 1994, as amended at 59 FR 19133, Apr. 22, 1994; 
62 FR 5319, Feb. 5, 1997; 62 FR 35076, June 30, 1997; 62 FR 46668, Sept. 
4, 1997; 62 FR 55160, Oct. 23, 1997; 64 FR 37673, July 13, 1999; 67 FR 
78355, Dec. 24, 2002; 70 FR 16934, Apr. 4, 2005; 70 FR 67353, Nov. 7, 
2005; 71 FR 13542, Mar. 16, 2006; 75 FR 10166, Mar. 5, 2010; 75 FR 
12981, Mar. 18, 2010; 76 FR 17338, Mar. 29, 2011; 77 FR 20988, Apr. 9, 
2012; 78 FR 21060, Apr. 9, 2013; 79 FR 28831, May 20, 2014; 81 FR 17607, 
Mar. 30, 2016; 81 FR 22523, Apr. 18, 2016; 81 FR 94990, Dec. 27, 2016; 
83 FR 48946, Sept. 28, 2018; 84 FR 8973, Mar. 13, 2019]



Sec. 520.2345e  Tetracycline solution.

    (a) Specifications. Each milliliter contains the equivalent of 
either 25 or 100 milligrams of tetracycline hydrochloride.
    (b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use--(1) Dogs--(i) Amount. 25 milligrams per pound 
of body weight per day in divided doses every 6 hours.
    (ii) Indications for use. Treatment of infections caused by 
organisms sensitive to tetracycline hydrochloride, such as bacterial 
gastroenteritis due to Escherichia coli and urinary tract infections due 
to Staphylococcus spp. and E. coli.
    (iii) Limitations. Administer orally; continue treatment until 
symptoms have subsided and the temperature is normal for 48 hours; not 
for use in animals which are raised for food production; Federal law 
restricts this drug to use by or on the order of a licensed 
veterinarian.
    (2) Dogs and cats--(i) Amount. 25 milligrams per pound of body 
weight per day in divided doses every 6 hours.
    (ii) Indications for use. Treatment of infections caused by 
organisms susceptible to tetracycline hydrochloride, such as bacterial 
gastroenteritis due to E. coli and urinary tract infections due to 
Staphylococcus spp. and E. coli.
    (iii) Limitations. Administer orally; continue treatment until the 
temperature has been normal for 48 hours; not for use in food-producing 
animals; Federal law restricts this drug to use by or on the order of a 
licensed veterinarian.

[57 FR 37329, Aug. 18, 1992, as amended at 79 FR 28831, May 20, 2014]

[[Page 257]]



Sec. 520.2345f  Tetracycline phosphate complex and sodium novobiocin
capsules.

    (a) Specifications. Each capsule contains the equivalent of 60 
milligrams of tetracycline hydrochloride and 60 milligrams of 
novobiocin.
    (b) Sponsor. No. 054771 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in dogs--(1) Amount. 10 milligrams of each 
antibiotic per pound of body weight (1 capsule for each 6 pounds) every 
12 hours.
    (2) Indications for use. Treatment of acute or chronic canine 
respiratory infections such as tonsillitis, bronchitis, and 
tracheobronchitis when caused by pathogens susceptible to tetracycline 
and/or novobiocin, such as Staphylococcus spp. and Escherichia coli.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[57 FR 37329, Aug. 18, 1992, as amended at 79 FR 28831, May 20, 2014]



Sec. 520.2345g  Tetracycline hydrochloride and sodium novobiocin tablets.

    (a) Specifications. Each tablet contains the equivalent of 60 
milligrams of tetracycline hydrochloride and 60 milligrams of 
novobiocin, or 180 milligrams of tetracycline hydrochloride and 180 
milligrams of novobiocin.
    (b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in dogs--(1) Amount. 10 milligrams of each 
antibiotic per pound of body weight (one single-strength tablet for each 
6 pounds or one triple-strength tablet for each 18 pounds).
    (2) Indications for use. Treatment of acute or chronic canine 
respiratory infections such as tonsillitis, bronchitis, and 
tracheobronchitis when caused by pathogens susceptible to tetracycline 
and/or novobiocin, such as Staphylococcus spp. and Escherichia coli.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[57 FR 37329, Aug. 18, 1992, as amended at 79 FR 28831, May 20, 2014]



Sec. 520.2345h  Tetracycline hydrochloride, sodium novobiocin, 
and prednisolone tablets.

    (a) Specifications. Each tablet contains the equivalent of 60 
milligrams of tetracycline hydrochloride, 60 milligrams of novobiocin, 
and 1.5 milligrams of prednisolone or 180 milligrams of tetracycline 
hydrochloride, 180 milligrams of novobiocin, and 4.5 milligrams of 
prednisolone.
    (b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in dogs--(1) Amount. 10 milligrams of each 
antibiotic and 0.25 milligram of prednisolone per pound of body weight 
(one single-strength tablet for each 6 pounds or one triple-strength 
tablet for each 18 pounds) every 12 hours for 48 hours. Treatment is to 
be continued with novobiocin and tetracycline alone at the same dose 
schedule for an additional 3 days or longer as needed.
    (2) Indications for use. Treatment of acute and chronic canine 
respiratory infections such as tonsillitis, bronchitis, and 
tracheobronchitis when caused by pathogens susceptible to tetracycline 
and/or novobiocin, such as Staphylococcus spp. and Escherichia coli, 
when it is necessary to initially reduce the severity of associated 
clinical signs.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[57 FR 37329, Aug. 18, 1992, as amended at 79 FR 28832, May 20, 2014]



Sec. 520.2362  Thenium closylate.

    (a) Specifications. Each tablet contains thenium closylate 
equivalent to 500 milligrams thenium base.
    (a) Specifications. Thenium closylate tablets contain thenium 
closylate equivalent to 500 milligrams thenium as base in each tablet.
    (b) Sponsor. See No. 000061 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in dogs--(1) Amount. Dogs weighing over 10 
pounds: Administer 1 tablet as a single dose. Dogs weighing 5 to 10 
pounds: Administered one-half tablet twice during a single day. Repeat 
treatment after 2 or 3 weeks.

[[Page 258]]

    (2) Indications for use. For treatment of canine ancylostomiasis by 
the removal from the intestines of the adult forms of the species 
Ancylostoma caninum and Uncinaria stenocephala (hookworms).
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[40 FR 13838, Mar. 27, 1975, as amended at 41 FR 53477, Dec. 7, 1976; 46 
FR 48642, Oct. 2, 1981; 61 FR 8873, Mar. 6, 1996; 62 FR 61625, Nov. 19, 
1997; 79 FR 28832, May 20, 2014]



Sec. 520.2380  Thiabendazole oral dosage forms.



Sec. 520.2380a  Thiabendazole top dressing and mineral protein block.

    (a) Specifications. Conforms to N.F. XII.
    (b) Sponsors. See sponsors in Sec. 510.600(c) of this chapter for 
use as in paragraph (d) of this section.
    (1) [Reserved]
    (2) No. 000010 for use as in paragraph (d)(1)(ii) of this section.
    (3) No. 012286 for use as in paragraph (d)(2) of this section.
    (c) Related tolerances. See Sec. 556.730 of this chapter.
    (d) Conditions of use. It is used as follows:
    (1) Horses. (i) [Reserved]
    (ii) Route of administration. In feed.
    (a) Amount. 2 grams per 100 pounds of body weight.
    (1) Indications for use. For control of large and small strongyles, 
Strongyloides, and pinworms of the genera Strongylus, Cyathostomum, 
Cylicobrachytus and related genera, Craterostomum, Oesophagodontus, 
Poteriostomum, Oxyuris, and Strongyloides.
    (2) Limitations. Administer in a single dosage mixed with the normal 
grain ration given at one feeding. Warning: Not for use in horses 
intended for food.
    (b) Amount. 4 grams per 100 pounds of body weight.
    (1) Indications for use. For control of ascarids of the genus 
Parascaris.
    (2) Limitations. Administer in a single dosage mixed with the normal 
grain ration given at one feeding. Warning: Not for use in horses 
intended for food.
    (2) Cattle--(i) Route of administration. In feed block.
    (ii) Amount. 3.3 percent block consumed at the recommended level of 
0.11 pound per 100 pounds of body weight per day.
    (iii) Indications for use. For control of infections of 
gastrointestinal roundworms (Trichostrongylus, Haemonchus, Ostertagia 
and Cooperia).
    (iv) Limitations. Administer to cattle on pasture or range 
accustomed to mineral protein block feeding for 3 days. Milk taken from 
animals during treatment and within 96 hours (8 milkings) after the 
latest treatment must not be used for food. Do not treat cattle within 3 
days of slaughter. For a satisfactory diagnosis, a microscopic fecal 
examination should be performed by a veterinarian or diagnostic 
laboratory prior to worming. Animals maintained under conditions of 
constant worm exposure may require re-treatment within 2 to 3 weeks. 
Animals that are severely parasitized, sick, or off feed should be 
isolated and a veterinarian consulted for advice concerning treatment.

[40 FR 13838, Mar. 27, 1975, as amended at 41 FR 9149, Mar. 3, 1976; 62 
FR 63271, Nov. 28, 1997; 70 FR 32489, June 3, 2005; 73 FR 35340, June 
23, 2008; 79 FR 28832, May 20, 2014; 83 FR 48946, Sept. 28, 2018; 84 FR 
39183, Aug. 9, 2019]



Sec. 520.2380b  Thiabendazole drench or paste.

    (a) Specifications. Conforms to N.F. XII.
    (b) Sponsor. See No. 000010 in Sec. 510.600(c) of this chapter.
    (c) Related tolerances. See Sec. 556.730 of this chapter.
    (d) Conditions of use. It is used as follows:
    (1) Horses. As a single liquid oral dose, administered as a drench 
or by stomach tube; or as an oral paste.
    (i) Amount. 2 grams per 100 pounds of body weight.
    (a) Indications for use. For the control of infections of large 
strongyles (Strongylus vulgaris, Strongylus endentatus), small 
strongyles (Cyathastomum, Cylicobrachytus and related genera, 
Craterostomum, Oesophagodontus, Poteriostomum), pinworms (Oxyuris), and 
threadworms (Strongyloides).
    (b) Limitations. Not for use in horses to be slaughtered for food 
purposes.

[[Page 259]]

When administered by stomach tube, for use only by or on the order of a 
licensed veterinarian. When for use as a liquid oral drench or an oral 
paste, consult your veterinarian for assistance in the diagnosis, 
treatment, and control of parasitism.
    (ii) Amount. 4 grams per 100 pounds of body weight.
    (a) Indications for use. For control of infections of ascardis 
(Parascaris).
    (b) Limitations. Not for use in horses to be slaughtered for food 
purposes. When administered by stomach tube, use only by or on the order 
of a licensed veterinarian. When for use as a liquid oral drench or an 
oral paste, consult your veterinarian for assistance in the diagnosis, 
treatment, and control of parasitism.
    (2) Pigs. As an oral paste.
    (i) Amount. 200 milligrams for each 5 to 7 pounds of body weight per 
dose.
    (ii) Indications for use. For control of infections with 
Strongyloides ransomi. These infections are commonly found in 
Southeastern United States.
    (iii) Limitations. Administer to baby pigs (1 to 8 weeks of age). 
Treatment may be repeated in 5 to 7 days if necessary. Before treatment, 
obtain an accurate diagnosis from a veterinarian or diagnostic 
laboratory. Do not treat within 30 days of slaughter.
    (3) Cattle. Orally as a drench and in paste form using a dosing gun 
designed for the product.
    (i) Amount. 3 grams per 100 pounds of body weight.
    (a) Indications for use. Control of infections of gastrointestinal 
roundworms (Trichostrongylus spp., Haemonchus spp., Nematodirus spp., 
Ostertagia spp., and Oesophagostomum radiatum).
    (b) Limitations. For most effective results, severely parasitized 
animals or those constantly exposed to helminth infection should be re-
treated every 2 to 3 weeks. Milk taken from treated animals within 96 
hours (8 milkings) after the latest treatment must not be used for food. 
Do not treat cattle within 3 days of slaughter. For a satisfactory 
diagnosis, a microscopic fecal examination should be performed prior to 
worming.
    (ii) Amount. 5 grams per 100 pounds of body weight.
    (a) Indications for use. Control of infections of Cooperia spp. or 
severe infections of other species in paragraph (e)(3)(i)(a) of this 
section.
    (b) Limitations. For most effective results, severely parasitized 
animals or those constantly exposed to helminth infection should be re-
treated every 2 to 3 weeks. Milk taken from treated animals within 96 
hours (8 milkings) after the latest treatment must not be used for food. 
Do not treat cattle within 3 days of slaughter. For a satisfactory 
diagnosis, a microscopic fecal examination should be performed prior to 
worming.
    (4) Sheep and goats. Orally, as a drench.
    (i) Amount. 2 grams per 100 pounds of body weight.
    (ii) Indications for use. Control of infections of gastrointestinal 
roundworms in sheep and goats. (Trichostrongylus spp., Haemonchus spp., 
Ostertagia spp., Cooperia spp., Nematodirus spp., Bunostomum spp., 
Strongyloides spp., Chabertia spp., and Oesophagostomum spp.); also 
active from 3 hours to 3 days following treatment against ova and larvae 
passed by sheep (good activity against Trichostrongylus colubriformis 
and axei, Ostertagia spp., Bunostomum spp., Nematodirus spp., and 
Strongyloides spp.; less effective against Haemonchus contortus and 
Oesophagostomum spp.).
    (iii) Limitations. As a single oral dose; do not treat animals 
within 30 days of slaughter; milk taken from treated animals within 96 
hours (8 milkings) after the latest treatment must not be used for food; 
in severe infections in sheep, treatment should be repeated in 2 to 3 
weeks.
    (5) Goats. Orally, as a drench.
    (i) Amount. 3 grams per 100 pounds of body weight.
    (ii) Indications for use. Control of severe infections of 
gastrointestinal roundworms (Trichostrongylus spp., Haemonchus spp., 
Ostertagia spp., Cooperia spp., Nematodirus spp., Bunostomum spp., 
Strongyloides spp., Chabertia spp., and Oesophagostomum spp.).
    (iii) Limitations. As a single oral dose; do not treat animals 
within 30 days of slaughter; milk taken from treated animals within 96 
hours (8 milkings)

[[Page 260]]

after the latest treatment must not be used for food; treatment should 
be repeated in 2 to 3 weeks.

[40 FR 13838, Mar. 27, 1975, as amended at 41 FR 9149, Mar. 3, 1976; 41 
FR 47424, Oct. 29, 1976; 62 FR 63271, Nov. 28, 1997; 79 FR 28832, May 
20, 2014; 84 FR 39183, Aug. 9, 2019]



Sec. 520.2380c  Thiabendazole bolus.

    (a) Specifications. Conforms to N.F. XII.
    (b) Sponsor. See No. 000010 in Sec. 510.600(c) of this chapter.
    (c) Related tolerances. See Sec. 556.730 of this chapter.
    (d) Conditions of use. It is used as follows:
    (1) Cattle. In a bolus.
    (i) Amount. 3 grams per 100 pounds of body weight.
    (a) Indications for use. Control of infections of gastrointestinal 
roundworms (general Trichostrongylus spp., Haemonchus spp., Nematodirus 
spp., Ostertagia spp., and Oesophagostomum radiatum).
    (b) Limitations. As a single oral dose; may repeat once in 2 to 3 
weeks; do not treat animals within 3 days of slaughter; milk taken from 
treated animals within 96 hours (8 milkings) after the latest treatment 
must not be used for food.
    (ii) Amount. 5 grams per 100 pounds of body weight.
    (a) Indications for use. Control of severe infections of 
gastrointestinal roundworms (genera Trichostrongylus spp., Haemonchus 
spp., Nematodirus spp., Ostertagia spp., and Oesophagostomum radiatum). 
Control of infections with Cooperia spp.
    (b) Limitations. As a single oral dose; as a drench or bolus; may 
repeat once in 2 to 3 weeks; do not treat animals within 3 days of 
slaughter; milk taken from treated animals within 96 hours (8 milkings) 
after the latest treatment must not be used for food.
    (2) Sheep and goats. In a bolus.
    (i) Amount. 2 grams per 100 pounds of body weight.
    (ii) Indications for use. Control of infections of gastrointestinal 
roundworms in sheep and goats (general Trichostrongylus spp., Haemonchus 
spp., Ostertagia spp., Cooperia spp., Nematodirus spp., Bunostomum spp., 
Strongyloides spp., Chabertia spp., and Oesophagostomum spp.); also 
active from 3 hours to 3 days following treatment against ova and larvae 
passed by sheep (good activity against T. colubriformis and axei, 
Ostertagia spp., Bunostomum spp., Nematodirus spp., and Strongyloides 
spp.; less effective against Haemonchus contortus and Oesophagostomum 
spp.).
    (iii) Limitations. As a single oral dose; do not treat animals 
within 30 days of slaughter; milk taken from treated animals within 96 
hours (8 milkings) after the latest treatment must not be used for food; 
in severe infections in sheep, treatment should be repeated in 2 to 3 
weeks.
    (3) Goats. In a bolus.
    (i) Amount. 3 grams per 100 pounds of body weight.
    (ii) Indications for use. Control of severe infections of 
gastrointestinal roundworms (genera Trichostrongylus spp., Haemonchus 
spp., Ostertagia spp., Cooperia spp., Nematodirus spp., Bunostomum spp., 
Strongyloides spp., Chabertia spp., and Oesophagostomum spp.).
    (iii) Limitations. As a single oral dose; do not treat animals 
within 30 days of slaughter; milk taken from treated animals within 96 
hours (8 milkings) after the latest treatment must not be used for food; 
treatment should be repeated in 2 to 3 weeks.

[40 FR 13838, Mar. 27, 1975, as amended at 41 FR 9149, Mar. 3, 1976; 62 
FR 63271, Nov. 28, 1997; 79 FR 28832, May 20, 2014; 84 FR 39183, Aug. 9, 
2019]



Sec. 520.2380d  Thiabendazole and piperazine citrate.

    (a) Specifications. Each fluid ounce of suspension contains 2 grams 
of thiabendazole and 2.5 grams of piperazine (from piperazine citrate).
    (b) Sponsor. See No. 000010 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in horses--(1) Amount. Administer 1 ounce of 
suspension per 100 pounds of body weight by stomach tube or as a drench.
    (2) Indications for use. For the control of large strongyles, small 
strongyles, pinworms, Strongyloides and ascarids (including members of 
the genera Strongylus spp., Cyathostomum spp., Cylicobrachytus spp. and 
related genera Craterostomum spp., Oesophagodontus

[[Page 261]]

spp., Poteriostomum spp., Oxyuris spp., Strongyloides spp., and 
Parascaris spp.).
    (3) Limitations. Do not use in horses intended for human 
consumption. Federal law restricts this drug to use by or on the order 
of a licensed veterinarian.

[40 FR 13838, Mar. 27, 1975, as amended at 62 FR 63271, Nov. 28, 1997; 
79 FR 28832, May 20, 2014; 84 FR 39183, Aug. 9, 2019]



Sec. 520.2380e  Thiabendazole and piperazine phosphate.

    (a) Specifications. Each ounce of water dispersible powder contains 
6.67 grams of thiabendazole and 8.33 grams of piperazine (as piperazine 
phosphate).
    (b) Sponsor. See No. 000010 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in horses--(1) Amount. 2 grams of 
thiabendazole and 2.5 grams of piperazine (0.3 ounce of powder) per 100 
pounds of body weight. Use a single oral dose. Administer as a drench or 
by stomach tube suspended in 1 pint of warm water; by dose syringe 
suspended in \1/2\ ounce of water for each 100 pounds of body weight; or 
sprinkled over a small amount of daily feed.
    (2) Indications for use. Treatment of infections of large strongyles 
(genus Strongylus), small strongyles (genera Cyathostomum, 
Cylicobrachytus, and related genera Craterostomum, Oesophagodontus, 
Poteriostomum), pinworms (Oxyuris), threadworms (Strongyloides), and 
ascarids (Parascaris) in horses.
    (3) Limitations. Do not use in horses intended for human 
consumption. If the label bears directions for administration by stomach 
tube or drench, it shall also bear the statement ``Caution: Federal law 
restricts this drug to use by or on the order of a licensed 
veterinarian.''; if not labeled for use by stomach tube or drench, the 
label shall bear the statement, ``Consult your veterinarian for 
assistance in the diagnosis, treatment, and control of parasitism.''

[46 FR 18963, Mar. 27, 1981, as amended at 46 FR 52330, Oct. 27, 1981; 
62 FR 63271, Nov. 28, 1997; 79 FR 28832, May 20, 2014. Redesignated and 
amended at 84 FR 39183, Aug. 9, 2019]



Sec. 520.2380f  Thiabendazole and triclorfon.

    (a) Specifications. The drug contains 5 grams of thiabendazole with 
4.5 grams of trichlorfon, or 20 grams of thiabendazole with 18 grams of 
trichlorfon.
    (b) Sponsor. See No. 017135 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in horses--(1) Amount. Administer 2 grams of 
thiabendazole with 1.8 grams of trichlorfon per 100 pounds of body 
weight sprinkled on the animals' usual daily ration of feed, or may be 
mixed in 5 to 10 fluid ounces of water and administered by stomach tube 
or drench.
    (2) Indications for use. For the treatment and control of bots 
(Gasterophilus spp.), large strongyles (Strongylus spp.), small 
strongyles (genera Cyathostomum, Cylicobrachytus, Craterostomum, 
Oesophagodontus, Poteriostomum), pinworms (Oxyuris spp., Strongyloides 
spp.), and ascarids (Parascaris spp.).
    (3) Limitations. Do not use in horses intended for human 
consumption. Federal law restricts this drug to use by or on the order 
of a licensed veterinarian.

[40 FR 23071, May 28, 1975, as amended at 48 FR 48229, Oct. 18, 1983; 79 
FR 28832, May 20, 2014. Redesignated at 84 FR 39183, Aug. 9, 2019]



Sec. 520.2455  Tiamulin.

    (a) Specifications. (1) Each gram of soluble powder contains 450 
milligrams (mg) tiamulin hydrogen fumarate.
    (2) Each milliliter (mL) of solution contains 125 mg (12.5 percent) 
tiamulin hydrogen fumarate.
    (3) Each mL of solution contains 123 mg (12.3 percent) tiamulin 
hydrogen fumarate.
    (b) Sponsors. See sponsor numbers in Sec. 510.600(c) of this 
chapter for use as in paragraph (d) of this section.
    (1) No. 058198 for products described in paragraphs (a)(1) and (3) 
of this section.
    (2) No. 066104 for the product described in paragraph (a)(1) of this 
section.
    (3) No. 054771 for the product described in paragraph (a)(3) of this 
section.
    (4) Nos. 016592 and 061133 for product described in paragraph (a)(2) 
of this section.
    (c) Related tolerances. See Sec. 556.732 of this chapter.

[[Page 262]]

    (d) Conditions of use in swine--(1) Amounts and indications for use. 
Administer in drinking water for 5 consecutive days:
    (i) 3.5 mg per (/) lb of body weight daily for treatment of swine 
dysentery associated with Brachyspira hyodysenteriae susceptible to 
tiamulin.
    (ii) 10.5 mg/lb of body weight daily for treatment of swine 
pneumonia due to Actinobacillus pleuropneumoniae susceptible to 
tiamulin.
    (2) Limitations. Use as only source of drinking water. Prepare fresh 
medicated water daily. Withdraw medication 3 days before slaughter 
following treatment at 3.5 mg/lb and 7 days before slaughter following 
treatment at 10.5 mg/lb of body weight. Swine being treated with 
tiamulin should not have access to feeds containing polyether ionophores 
(e.g., lasalocid, monensin, narasin, salinomycin, or semduramycin) as 
adverse reactions may occur. The effects of tiamulin on swine 
reproductive performance, pregnancy, and lactation have not been 
determined.

[70 FR 75017, Dec. 19, 2005, as amended at 74 FR 7180, Feb. 13, 2009; 75 
FR 54492, Sept. 8, 2010; 77 FR 56770, Sept. 14, 2012; 78 FR 17596, Mar. 
22, 2013; 80 FR 13229, Mar. 13, 2015; 85 FR 18119, Apr. 1, 2020; 86 FR 
13184, Mar. 8, 2021; 86 FR 14819, Mar. 19, 2021]



Sec. 520.2471  Tilmicosin.

    (a) Specifications. Each milliliter of concentrate solution contains 
250 milligrams (mg) tilmicosin as tilmicosin phosphate.
    (b) Sponsor. See No. 058198 in Sec. 510.600(c) of this chapter.
    (c) Tolerances. See Sec. 556.735 of this chapter.
    (d) Conditions of use in swine--(1) Amount. Administer in drinking 
water at a concentration of 200 mg per liter for 5 consecutive days.
    (2) Indications for use. (i) For the control of swine respiratory 
disease associated with Pasteurella multocida and Haemophilus parasuis 
in groups of swine in buildings where a respiratory disease outbreak is 
diagnosed.
    (ii) For the control of swine respiratory disease associated with 
Mycoplasma hyopneumoniae in the presence of Porcine Reproductive and 
Respiratory Syndrome Virus (PRRSV) in groups of swine in buildings where 
a respiratory disease outbreak is diagnosed.
    (3) Limitations. Swine intended for human consumption must not be 
slaughtered within 7 days of the last treatment with this product. 
Federal law restricts this drug to use by or on the order of a licensed 
veterinarian.

[79 FR 18158, Apr. 1, 2014, as amended at 81 FR 17608, Mar. 30, 2016; 81 
FR 48702, July 26, 2016]



Sec. 520.2473  Tioxidazole oral dosage forms.



Sec. 520.2473a  Tioxidazole granules.

    (a) Specifications. Each gram of granules contains 200 milligrams of 
tioxidazole.
    (b) Sponsor. See No. 000061 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use--(1) Horses--(i) Amount. 5 milligrams per 
pound of body weight as a single dose.
    (ii) Indications for use. Removal of mature large strongyles 
(Strongylus edentatus, S. equinus, and S. vulgaris), mature ascarids 
(Parascaris equorum), mature and immature (4th larval stage) pinworms 
(Oxyuris equi), and mature small strongyles (Triodontophorus spp.).
    (iii) Limitations. For administration with feed: Sprinkle required 
amount of granules on a small amount of the usual grain ration and mix. 
Prepare for each horse individually. Withholding of feed or water not 
necessary. Not for use in horses intended for food. The reproductive 
safety of tioxidazole in breeding animals has not been determined. 
Consult your veterinarian for assistance in the diagnosis, treatment, 
and control of parasitism. It is recommended that this drug be 
administered with caution to sick or debilitated horses.
    (2) [Reserved]

[50 FR 52772, Dec. 26, 1985; 51 FR 2693, Jan. 21, 1986, as amended at 52 
FR 7832, Mar. 13, 1987]



Sec. 520.2473b  Tioxidazole paste.

    (a) Specifications. Each plastic syringe contains 6.25 grams of 
tioxidazole.
    (b) Sponsor. See No. 000061 in Sec. 510.600(c) of this chapter.

[[Page 263]]

    (c) Conditions of use--(1) Horses--(i) Amount. 5 milligrams of 
tioxidazole per pound of body weight as a single dose.
    (ii) Indications for use. Removal of mature large strongyles 
(Strongylus edentatus, S. equinus, and S. vulgaris), mature ascarids 
(Parascaris equorum), mature and immature (4th larval stage) pinworms 
(Oxyuris equi), and mature small strongyles (Triodontophorus spp.).
    (iii) Limitations. Administer orally by inserting the nozzle of the 
syringe through the space between front and back teeth and deposit the 
required dose on the base of the tongue. Before dosing, make sure the 
horse's mouth contains no feed. Not for use in horses intended for food. 
The reproductive safety of tioxidazole in breeding animals has not been 
determined. Consult your veterinarian for assistance in the diagnosis, 
treatment, and control of parasitism. It is recommended that this drug 
be administered with caution to sick or debilitated horses.
    (2) [Reserved]

[52 FR 43059, Nov. 9, 1987]



Sec. 520.2475  Toceranib.

    (a) Specifications. Each tablet contains 10, 15, or 50 milligrams 
(mg) toceranib as toceranib phosphate.
    (b) Sponsor. See No. 054771 in Sec. 510.600 of this chapter.
    (c) Conditions of use--(1) Dogs--(i) Amount. Administer an initial 
dose of 3.25 mg per kilogram (1.48 mg per pound) body weight, orally 
every other day.
    (ii) Indications for use. For the treatment of Patnaik grade II or 
III, recurrent, cutaneous mast cell tumors with or without regional 
lymph node involvement.
    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.
    (2) [Reserved]

[74 FR 28875, June 18, 2009, as amended at 79 FR 28832, May 20, 2014]



Sec. 520.2483  Triamcinolone.

    (a) Specifications. (1) Each tablet contains 0.5 milligram (mg) or 
1.5 mg triamcinolone acetonide.
    (2) Each 15 grams of powder contains 10 mg triamcinolone acetonide.
    (b) Sponsor. See No. 000010 in Sec. 510.600(c) of this chapter.
    (c) Special considerations. See Sec. 510.410 of this chapter.
    (d) Conditions of use--(1) Dogs and cats. Use tablets described in 
paragraph (a)(1) of this section as follows:
    (i) Amount. Administer 0.05 mg per pound (/lb) of body weight daily 
by mouth; up to 0.1 mg per pound (/lb) of body weight daily, if response 
to the smaller dose is inadequate. Therapy may be initiated with a 
single injection of triamcinolone acetonide suspension as in Sec. 
522.2483 of this chapter, in which case triamcinolone acetonide tablets 
should be administered beginning 5 to 7 days after the injection.
    (ii) Indications for use. As an anti-inflammatory agent.
    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.
    (2) Horses. Use oral powder described in paragraph (a)(2) of this 
section as follows:
    (i) Amount. Administer 0.005 to 0.01 mg/lb of body weight twice 
daily, sprinkled (top-dressed) on a small portion of feed. Therapy may 
be initiated with a single injection of triamcinolone acetonide 
suspension as in Sec. 522.2483 of this chapter, in which case 
triamcinolone acetonide oral powder should be administered beginning 3 
or 4 days after the injection.
    (ii) Indications for use. As an anti-inflammatory agent.
    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian. Do not use in horses intended for 
human consumption.

[75 FR 10166, Mar. 5, 2010]



Sec. 520.2520  Trichlorfon oral dosage forms.



Sec. 520.2520a  Trichlorfon and atropine.

    (a) Specifications. (1) For trichlorfon: O,O-Dimethyl 2,2,2-
trichloro-1-hydroxyethyl phosphonate.
    (2) For atropine: Atropine N.F.
    (b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in mice--(1) Amount. Administer 1.67 grams of 
trichlorfon and 7.7 milligrams of atropine per liter continuously for 7 
to 14

[[Page 264]]

days as the sole source of drinking water.
    (2) Indications for use. For the treatment of Syphacia obvelata 
(pinworm) in laboratory mice.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[79 FR 28832, May 20, 2014]



Sec. 520.2520b  Trichlorfon boluses.

    (a) Specifications. Each bolus contains either 7.3, 10.9, 14.6, or 
18.2 g of trichlorfon.
    (b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in horses--(1) Amount. 18.2 milligrams per 
pound of body weight, except for strongyles use 36.4 milligrams per 
pound of body weight.
    (2) Indications for use. For horses for removal of bots 
(Gastrophilus nasalis, Gastrophilus intestinalis), large strongyles 
(Strongylus vulgaris), small strongyles, large roundworms (ascarids, 
Parascaris equorum), and pinworms (Oxyuris equi).
    (3) Limitations. Do not use in horses intended for human 
consumption. Federal law restricts this drug to use by or on the order 
of a licensed veterinarian.

[45 FR 48127, July 18, 1980. Redesignated and amended at 79 FR 28833, 
May 20, 2014]



Sec. 520.2520c  Trichlorfon granules.

    (a) Specifications. Each package contains either 18.2 or 36.4 g of 
trichlorfon.
    (b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in horses--(1) Amount. 18.2 milligrams per 
pound of body weight.
    (2) Indications for use. For horses for removal of bots 
(Gastrophilus nasalis, Gastrophilus intestinalis), large roundworms 
(ascarids, Parascaris equorum), and pinworms (Oxyuris equi).
    (3) Limitations. Do not use in horses intended for human 
consumption. Federal law restricts this drug to use by or on the order 
of a licensed veterinarian.

[45 FR 48128, July 18, 1980. Redesignated and amended at 79 FR 28833, 
May 20, 2014]



Sec. 520.2520d  Trichlorfon, phenothiazine, and piperazine.

    (a) Specifications. Each 54.10 grams (1.91 ounces) of water 
dispersible powder contains 9.10 grams of trichlorfon, 6.25 grams of 
phenothiazine, and the equivalent of 20.0 grams of piperazine base (as 
piperazine dihydrochloride).
    (b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in horses--(1) Amount. 18.2 milligrams (mg) of 
trichlorfon, 12.5 mg of phenothiazine, and 40 mg of piperazine base per 
pound of body weight.
    (2) Indications for use. For removal of bots (Gastrophilus nasalis, 
Gastrophilus intestinalis), large strongyles (Strongylus vulgaris), 
small strongyles, large roundworms (ascarids, Parascaris equorum), and 
pinworms (Oxyuris equi).
    (3) Limitations. Do not use in horses intended for human 
consumption. Federal law restricts this drug to use by or on the order 
of a licensed veterinarian.

[48 FR 2757, Jan. 21, 1983. Redesignated and amended at 79 FR 28833, May 
20, 2014; 85 FR 4208, Jan. 24, 2020]

    Editorial Note: At 79 FR 28833, May 20, 2014, Sec. 520.2520d was 
amended in part by redesignating paragraph (e) as (c). This action could 
not be performed because paragraph (e) did not exist.



Sec. 520.2582  Triflupromazine.

    (a) Specifications. Each tablet contains 10 or 25 milligrams (mg) 
triflupromazine hydrochloride.
    (b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in dogs and cats--(1) Amount. Administer 
orally 1 to 2 mg per pound of body weight daily, followed by 1 mg daily.
    (2) Indications for use. For relief of anxiety, to help control 
psychomotor over-activity, and to increase the tolerance of animals to 
pain and pruritus. For use in various clinical procedures which require 
the aid of a tranquilizer, antiemetic, or preanesthetic.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[79 FR 28833, May 20, 2014]

[[Page 265]]



Sec. 520.2598  Trilostane.

    (a) Specifications. Each capsule contains 5, 10, 30, 60, or 120 
milligrams (mg) trilostane.
    (b) Sponsor. See No. 043264 in Sec. 510.600 of this chapter.
    (c) Conditions of use in dogs--(1) Amount. The starting dose is 1.0 
to 3.0 milligrams per pound (2.2 to 6.7 milligrams per kilogram) once a 
day.
    (2) Indications for use. For treatment of pituitary-dependent 
hyperadrenocorticism. For treatment of hyperadrenocorticism due to 
adrenocortical tumor.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[74 FR 21767, May 11, 2009, as amended at 74 FR 30464, June 26, 2009; 80 
FR 53460, Sept. 4, 2015]



Sec. 520.2604  Trimeprazine and prednisolone tablets.

    (a) Specifications. Each tablet contains 5 milligrams (mg) 
trimeprazine tartrate and 2 mg prednisolone.
    (b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in dogs--(1) Amount. Administer orally an 
initial dosage: for dogs weighing up to 10 pounds, \1/2\ tablet twice 
daily; for dogs weighing 11 to 20 pounds, 1 tablet twice daily; for dogs 
weighing 21 to 40 pounds, 2 tablets twice daily; and for dogs weighing 
over 40 pounds, 3 tablets twice daily. After 4 days, reduce dosage to 
one-half the initial dose or to an amount sufficient to maintain 
remission of symptoms.
    (2) Indications for use. For the relief of itching regardless of 
cause; and for reduction of inflammation commonly associated with most 
skin disorders of dogs such as eczema, caused by internal disorders, 
otitis, and dermatitis, allergic, parasitic, pustular and nonspecific. 
As adjunctive therapy in various cough conditions including treatment of 
``kennel cough'' or tracheobronchitis, bronchitis including allergic 
bronchitis, in tonsillitis, acute upper respiratory infections and 
coughs of nonspecific origin.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[79 FR 28833, May 20, 2014]



Sec. 520.2605  Trimeprazine and prednisolone capsules.

    (a) Specifications. Each capsule contains:
    (1) 3.75 milligrams (mg) trimeprazine in sustained released form (as 
trimeprazine tartrate) and 1 mg prednisolone (Capsule No. 1); or
    (2) 7.5 mg trimeprazine in sustained release form (as trimeprazine 
tartrate) and 2 mg prednisolone (Capsule No. 2).
    (b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in dogs--(1) Amount. Administer orally once 
daily an initial dosage:
    (i) For dogs weighing up to 10 pounds: one Capsule No. 1;
    (ii) For dogs weighing 11 to 20 pounds, one Capsule No. 2 or two 
Capsule No. 1;
    (iii) For dogs weighing 21 to 40 pounds, two Capsule No. 2 or four 
Capsule No. 1; and
    (iv) For dogs weighing over 40 pounds, three Capsule No. 2 or six 
Capsule No. 1. After 4 days, the dosage is reduced to approximately \1/
2\ the initial dosage or to an amount just sufficient to maintain 
remission of symptoms.
    (2) Indications for use. For the relief of itching regardless of 
cause; and for reduction of inflammation commonly associated with most 
skin disorders of dogs such as eczema, caused by internal disorders, 
otitis, and dermatitis, allergic, parasitic, pustular and nonspecific. 
As adjunctive therapy in various cough conditions including treatment of 
``kennel cough'' or tracheobronchitis, bronchitis including allergic 
bronchitis, in tonsillitis, acute upper respiratory infections and 
coughs of nonspecific origin.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[79 FR 28833, May 20, 2014]



Sec. 520.2610  Trimethoprim and sulfadiazine tablets.

    (a) Specifications. Each tablet contains 30 milligrams (mg) (5 mg

[[Page 266]]

trimethoprim and 25 mg sulfadiazine), 120 mg (20 mg trimethoprim and 100 
mg sulfadiazine), 480 mg (80 mg trimethoprim and 400 mg sulfadiazine) or 
960 mg (160 mg trimethoprim and 800 mg sulfadiazine).
    (b) Sponsors. See Nos. 000061 and 054771 in Sec. 510.600(c) of this 
chapter.
    (c) Conditions of use in dogs--(1) Amount. Administer orally at 30 
mg per kilogram of body weight (14 milligrams per pound) once daily. 
Alternatively, especially in severe infections, the initial dose may be 
followed by one-half the recommended daily dose every 12 hours. 
Administer for 2 to 3 days after symptoms have subsided. Do not treat 
for more than 14 consecutive days.
    (2) Indications for use. The drug is used in dogs where systemic 
antibacterial action against sensitive organisms is required, either 
alone or as an adjunct to surgery or debridement with associated 
infection. The drug is indicated where control of bacterial infection is 
required during the treatment of acute urinary tract infections, acute 
bacterial complications of distemper, acute respiratory tract 
infections, acute alimentary tract infections, wound infections, and 
abscesses.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[79 FR 28833, May 20, 2014]



Sec. 520.2611  Trimethoprim and sulfadiazine paste.

    (a) Specifications. Each gram (g) of paste contains 67 milligrams 
(mg) trimethoprim and 333 mg sulfadiazine.
    (b) Sponsors. See sponsors in Sec. 510.600(c) of this chapter:
    (1) No. 054771 for product administered as in paragraph (c)(1)(i) of 
this section.
    (2) No. 000061 for product administered as in paragraph (c)(1)(ii) 
of this section.
    (c) Conditions of use in horses--(1) Amount. Administer orally as a 
single daily dose for 5 to 7 days:
    (i) 5 g of paste (335 mg trimethoprim and 1,665 mg sulfadiazine) per 
150 pounds (68 kilograms) of body weight per day.
    (ii) 3.75 g of paste (250 mg trimethoprim and 1,250 mg sulfadiazine) 
per 110 pounds (50 kilograms) of body weight per day.
    (2) Indications for use. For use where systemic antibacterial action 
against sensitive organisms is required during treatment of acute 
strangles, respiratory infections, acute urogenital infections, and 
wound infections and abscesses.
    (3) Limitations. Not for use in horses intended for human 
consumption. Federal law restricts this drug to use by or on the order 
of a licensed veterinarian.

[71 FR 30802, May 31, 2006, as amended at 79 FR 28834, May 20, 2014]



Sec. 520.2612  Trimethoprim and sulfadiazine suspension.

    (a) Specifications. Each milliliter (mL) of suspension contains:
    (1) 10 milligrams (mg) trimethoprim and 50 mg sulfadiazine; or
    (2) 400 mg combined active ingredients (67 mg trimethoprim and 333 
mg sulfadiazine).
    (b) Sponsors. See sponsor numbers in Sec. 510.600 of this chapter:
    (1) No. 000061 for use of product described in paragraph (a)(1) for 
use as in paragraph (c)(1) of this section.
    (2) No. 051072 for use of product described in paragraph (a)(2) for 
use as in paragraph (c)(2) of this section.
    (c) Conditions of use--(1) Dogs--(i) Amount. Administer 1 mL (10 mg 
trimethoprim and 50 mg sulfadiazine) per 5 pounds (lb) of body weight 
once daily, or one-half the recommended daily dose every 12 hours, for 
up to 14 consecutive days.
    (ii) Indications for use. The drug is used in dogs where systemic 
antibacterial action against sensitive organisms is required, either 
alone or as an adjunct to surgery or debridement with associated 
infection. The drug is indicated where control of bacterial infection is 
required during the treatment of acute urinary tract infections, acute 
bacterial complications of distemper, acute respiratory tract 
infections, acute alimentary tract infections, wound infections, and 
abscesses.
    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.
    (2) Horses--(i) Amount. Administer orally at a dosage of 24 mg 
combined active ingredients per kilogram body

[[Page 267]]

weight (10.9 mg/lb) twice daily for 10 days. Administered by volume at 
2.7 mL per 45.4 kilograms of body weight (2.7 mL/100 lb).
    (ii) Indications for use. For the treatment of lower respiratory 
tract infections in horses caused by susceptible strains of 
Streptococcus equi subsp. zooepidemicus.
    (iii) Limitations. Do not use in horses intended for human 
consumption. Federal law restricts this drug to use by or on the order 
of a licensed veterinarian.

[78 FR 63872, Oct. 25, 2013, as amended at 85 FR 4208, Jan. 24, 2020]



Sec. 520.2613  Trimethoprim and sulfadiazine powder.

    (a) Specifications. Each gram of powder contains 67 milligrams (mg) 
trimethoprim and 333 mg sulfadiazine.
    (b) Sponsors. See Nos. 054771 and 059051 in Sec. 510.600(c) of this 
chapter.
    (c) Conditions of use in horses--(1) Amount. Administer orally 3.75 
grams of powder per 110 pounds (50 kilograms) of body weight in a small 
amount of feed, as a single daily dose, for 5 to 7 days.
    (2) Indications for use. For control of bacterial infections of 
horses during treatment of acute strangles, respiratory tract 
infections, acute urogenital infections, wound infections, and 
abscesses.
    (3) Limitations. Do not use in horses intended for human 
consumption. Federal law restricts this drug to use by or on the order 
of a licensed veterinarian.

[58 FR 36135, July 6, 1993, as amended at 64 FR 68289, Dec. 7, 1999; 79 
FR 28834, May 20, 2014; 79 FR 64116, Oct. 28, 2014]



Sec. 520.2640  Tylosin.

    (a) Specifications. Each container of soluble powder contains 
tylosin tartrate equivalent to either 100 or 256 grams tylosin base.
    (b) Sponsors. (1) Nos. 016592 and 058198 for use as in paragraph (e) 
of this section.
    (2) No. 061133 for use as in paragraphs (e)(1)(i)(A), (e)(1)(ii), 
(e)(2), (e)(3), and (e)(4) of this section.
    (c) Related tolerances. See Sec. 556.746 of this chapter.
    (d) Special considerations. Federal law restricts this drug to use 
by or on the order of a licensed veterinarian.
    (e) Conditions of use--(1) Chickens--(i) Amounts and indications for 
use. (A) Administer 2 grams per gallon (528 parts per million (ppm)) for 
1 to 5 days as an aid in the treatment of chronic respiratory disease 
(CRD) associated with Mycoplasma gallisepticum in broiler and 
replacement chickens. For the control of CRD associated with M. 
gallisepticum at time of vaccination or other stress in chickens. For 
the control of CRD associated with Mycoplasma synoviae in broiler 
chickens. Treated chickens should consume enough medicated drinking 
water to provide 50 milligrams (mg) tylosin per pound of body weight per 
day.
    (B) Administer 851 to 1,419 mg/gallon (225 to 375 ppm) for 5 days 
for the control of mortality caused by necrotic enteritis associated 
with Clostridium perfringens in broiler chickens.
    (ii) Limitations. Do not use in layers producing eggs for human 
consumption. Do not administer within 24 hours of slaughter.
    (2) Turkeys--(i) Amount. 2 grams per gallon for 2 to 5 days as the 
sole source of drinking water. Treated turkeys should consume enough 
medicated drinking water to provide 60 mg tylosin per pound of body 
weight per day.
    (ii) Indications for use. For the reduction in severity of effects 
of infectious sinusitis associated with Mycoplasma gallisepticum.
    (iii) Limitations. Do not use in layers producing eggs for human 
consumption. Do not administer within 5 days of slaughter.
    (3) Swine--(i) Amount. 250 mg per gallon as the only source of 
drinking water for 3 to 10 days, depending on the severity of the 
condition being treated.
    (ii) Indications for use. (A) For the treatment and control of swine 
dysentery associated with Brachyspira hyodysenteriae when followed 
immediately by tylosin phosphate medicated feed; and for the control of 
porcine proliferative enteropathies (PPE, ileitis) associated with 
Lawsonia intracellularis when followed immediately by tylosin phosphate 
medicated feed.
    (B) For the treatment and control of swine dysentery associated with 
Brachyspira hyodysenteriae.

[[Page 268]]

    (iii) Limitations. Do not administer within 48 hours of slaughter. 
As indicated in paragraph (d)(3)(ii)(A) of this section, follow with 
tylosin phosphate medicated feed as in Sec. 558.625(f)(1)(vi)(c) of 
this chapter.
    (4) Honey bees--(i) Amount. Mix 200 milligrams tylosin in 20 grams 
confectioners'/powdered sugar. Use immediately. Apply (dust) this 
mixture over the top bars of the brood chamber once weekly for 3 weeks.
    (ii) Indications for use. For the control of American foulbrood 
(Paenibacillus larvae).
    (iii) Limitations. The drug should be fed early in the spring or 
fall and consumed by the bees before the main honey flow begins, to 
avoid contamination of production honey. Complete treatments at least 4 
weeks before main honey flow.

[40 FR 13838, Mar. 27, 1975, as amended at 50 FR 49841, Dec. 5, 1985; 59 
FR 14365, Mar. 28, 1994; 62 FR 39443, July 23, 1997; 68 FR 24879, May 9, 
2003; 70 FR 69439, Nov. 16, 2005; 73 FR 76946, Dec. 18, 2008; 75 FR 
76259, Dec. 8, 2010; 76 FR 59024, Sept. 23, 2011; 77 FR 29217, May 17, 
2012; 79 FR 37620, July 2, 2014; 79 FR 53136, Sept. 8, 2014; 79 FR 
64116, Oct. 28, 2014; 80 FR 34278, June 16, 2015; 83 FR 14587, Apr. 5, 
2018; 84 FR 8973, Mar. 13, 2019; 84 FR 32992, July 11, 2019]



Sec. 520.2645  Tylvalosin.

    (a) Specifications. Granules containing 62.5 percent tylvalosin (w/
w) as tylvalosin tartrate.
    (b) Sponsor. See No. 066916 in Sec. 510.600(c) of this chapter.
    (c) Related tolerances. See Sec. 556.748 of this chapter.
    (d) Conditions of use in swine--(1) Amount. Administer 50 parts per 
million (ppm) tylvalosin continuously in drinking water for 5 
consecutive days.
    (2) Indications for use. For control of porcine proliferative 
enteropathy (PPE) associated with Lawsonia intracellularis infection in 
groups of swine in buildings experiencing an outbreak of PPE; and for 
control of swine respiratory disease (SRD) associated with Bordetella 
bronchiseptica, Haemophilus parasuis, Pasteurella multocida, and 
Streptococcus suis in groups of swine in buildings experiencing an 
outbreak of SRD.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[77 FR 55415, Sept. 10, 2012, as amended at 83 FR 13635, Mar. 30, 2018]



PART 522_IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
--Table of Contents



Sec.
522.23 Acepromazine.
522.52 Alfaxalone.
522.56 Amikacin.
522.62 Aminopentamide.
522.82 Aminopropazine.
522.88 Amoxicillin.
522.90 Ampicillin injectable dosage forms.
522.90a Ampicillin trihydrate suspension.
522.90b Ampicillin trihydrate powder for injection.
522.90c Ampicillin sodium.
522.144 Arsenamide.
522.147 Atipamezole.
522.150 Azaperone.
522.161 Betamethasone.
522.163 Betamethasone dipropionate and betamethasone sodium phosphate 
          aqueous suspension.
522.167 Betamethasone sodium phosphate and betamethasone acetate.
522.204 Boldenone.
522.224 Bupivacaine.
522.230 Buprenorphine.
522.234 Butamisole.
522.246 Butorphanol.
522.275 N-Butylscopolammonium.
522.304 Carprofen.
522.311 Cefovecin.
522.313 Ceftiofur injectable dosage forms.
522.313a Ceftiofur crystalline free acid.
522.313b Ceftiofur hydrochloride.
522.313c Ceftiofur sodium.
522.380 Chloral hydrate, pentobarbital, and magnesium sulfate.
522.390 Chloramphenicol.
522.454 Clodronate.
522.460 Cloprostenol.
522.468 Colistimethate sodium powder for injection.
522.480 Corticotropin.
522.522 Danofloxacin.
522.533 Deslorelin.
522.535 Desoxycorticosterone.
522.536 Detomidine.
522.540 Dexamethasone solution.
522.542 Dexamethasone suspension.
522.558 Dexmedetomidine.
522.563 Diatrizoate.
522.650 Dihydrostreptomycin sulfate injection.
522.690 Dinoprost.
522.723 Diprenorphine.
522.728 Dipyrone.
522.770 Doramectin.

[[Page 269]]

522.775 Doxapram.
522.784 Doxylamine.
522.800 Droperidol and fentanyl.
522.810 Embutramide, chloroquine, and lidocaine solution.
522.812 Enrofloxacin.
522.814 Eprinomectin.
522.820 Erythromycin.
522.840 Estradiol.
522.842 Estradiol benzoate and testosterone propionate.
522.850 Estradiol valerate and norgestomet in combination.
522.863 Ethylisobutrazine.
522.870 Etodolac.
522.883 Etorphine.
522.914 Fenprostalene.
522.930 Firocoxib.
522.955 Florfenicol.
522.956 Florfenicol and flunixin.
522.960 Flumethasone injectable dosage forms.
522.960a Flumethasone suspension.
522.960b Flumethasone acetate solution.
522.960c Flumethasone solution.
522.970 Flunixin.
522.995 Fluprostenol.
522.1002 Follicle stimulating hormone.
522.1010 Furosemide.
522.1014 Gamithromycin.
522.1020 Gelatin.
522.1044 Gentamicin.
522.1055 Gleptoferron.
522.1066 Glycopyrrolate.
522.1077 Gonadorelin.
522.1079 Serum gonadotropin and chorionic gonadotropin.
522.1081 Chorionic gonadotropin for injection; chorionic gonadotropin 
          suspension.
522.1083 Gonadotropin releasing factor analog-diphtheria toxoid 
          conjugate.
522.1085 Guaifenesin powder for injection.
522.1086 Guaifenesin solution.
522.1125 Hemoglobin glutamer-200 (bovine).
522.1145 Hyaluronate.
522.1150 Hydrochlorothiazide.
522.1155 Imidocarb powder for injection.
522.1156 Imidocarb solution.
522.1160 Insulin.
522.1182 Iron injection.
522.1185 Isoflupredone.
522.1192 Ivermectin.
522.1193 Ivermectin and clorsulon.
522.1204 Kanamycin.
522.1222 Ketamine.
522.1223 Ketamine, promazine, and aminopentamide.
522.1225 Ketoprofen.
522.1242 Levamisole.
522.1260 Lincomycin.
522.1289 Lufenuron.
522.1290 Luprostiol.
522.1315 Maropitant.
522.1335 Medetomidine.
522.1350 Melatonin implant.
522.1362 Melarsomine powder for injection.
522.1367 Meloxicam.
522.1372 Mepivacaine.
522.1380 Methocarbamol.
522.1410 Methylprednisolone.
522.1450 Moxidectin solution.
522.1451 Moxidectin microspheres for injection.
522.1452 Nalorphine.
522.1465 Naltrexone.
522.1468 Naproxen for injection.
522.1484 Neomycin.
522.1503 Neostigmine.
522.1610 Oleate sodium.
522.1660 Oxytetracycline injectable dosage forms.
522.1660a Oxytetracycline solution, 200 milligrams/milliliter.
522.1660b Oxytetracycline solution, 300 milligrams/milliliter.
522.1662 Oxytetracycline hydrochloride implantation or injectable dosage 
          forms.
522.1662a Oxytetracycline hydrochloride injection.
522.1662b Oxytetracycline hydrochloride with lidocaine injection.
522.1662 Oxytetracycline and flunixin.
522.1680 Oxytocin.
522.1684 Pegbovigrastim.
522.1696 Penicillin G procaine injectable dosage forms.
522.1696a Penicillin G benzathine and penicillin G procaine suspension.
522.1696b Penicillin G procaine aqueous suspension.
522.1696c Penicillin G procaine in oil.
522.1697 Pentobarbital and phenytoin.
522.1698 Pentazocine.
522.1704 Pentobarbital.
522.1720 Phenylbutazone.
522.1820 Pituitary luteinizing hormone powder for injection.
522.1850 Polysulfated glycosaminoglycan.
522.1862 Pralidoxime powder for injection.
522.1870 Praziquantel.
522.1881 Prednisolone acetate.
522.1883 Prednisolone sodium phosphate.
522.1884 Prednisolone sodium succinate.
522.1885 Prednisolone tertiary butylacetate.
522.1890 Prednisone suspension.
522.1920 Prochlorperazine and isopropamide.
522.1940 Progesterone and estradiol benzoate.
522.1962 Promazine.
522.2002 Propiopromazine.
522.2005 Propofol.
522.2012 Prostalene.
522.2063 Pyrilamine.
522.2075 Robenacoxib.
522.2076 Romifidine.
522.2092 Secobarbital and dibucaine.
522.2100 Selenium and vitamin E.
522.2112 Sometribove zinc suspension.
522.2120 Spectinomycin hydrochloride.
522.2121 Spectinomycin sulfate.
522.2150 Stanozolol.
522.2200 Sulfachlorpyridazine.
522.2220 Sulfadimethoxine.
522.2240 Sulfaethoxypyridazine.

[[Page 270]]

522.2260 Sulfamethazine.
522.2340 Sulfomyxin.
522.2404 Thialbarbitone sodium for injection.
522.2424 Thiamylal.
522.2444 Thiopental injectable dosage forms.
522.2444a Thiopental powder for injection.
522.2444b Thiopental and pentobarbital powder for injection.
522.2450 Tigilanol.
522.2460 Tildipirosin.
522.2470 Tiletamine and zolazepam for injection.
522.2471 Tilmicosin.
522.2473 Tiludronate.
522.2474 Tolazoline.
522.2476 Trenbolone acetate.
522.2477 Trenbolone acetate and estradiol.
522.2478 Trenbolone acetate and estradiol benzoate.
522.2483 Triamcinolone.
522.2582 Triflupromazine.
522.2610 Trimethoprim and sulfadiazine.
522.2615 Tripelennamine.
522.2630 Tulathromycin.
522.2640 Tylosin.
522.2662 Xylazine.
522.2670 Yohimbine.
522.2680 Zeranol.
522.2690 Zinc gluconate.

    Authority: 21 U.S.C. 360b.

    Source: 40 FR 13858, Mar. 27, 1975, unless otherwise noted.



Sec. 522.23  Acepromazine.

    (a) Specifications. Each milliliter of solution contains 10 
milligrams (mg) acepromazine maleate.
    (b) Sponsors. See Nos. 000010 and 058198 in Sec. 510.600(c) of this 
chapter.
    (c) Conditions of use in dogs, cats, and horses--(1) Amount. Dogs: 
0.25 to 0.5 mg per pound (/lb) of body weight; Cats: 0.5 to 1.0 mg/lb of 
body weight; Horses: 2.0 to 4.0 mg per 100 lbs of body weight.
    (2) Indications for use. For use as a tranquilizer and as a 
preanesthetic agent.
    (3) Limitations. Do not use in horses intended for human 
consumption. Federal law restricts this drug to use by or on the order 
of a licensed veterinarian.

[75 FR 10167, Mar. 5, 2010; 78 FR 17597, Mar. 22, 2013; 79 FR 16182, 
Mar. 25, 2014; 86 FR 14819, Mar. 19, 2021]



Sec. 522.52  Alfaxalone.

    (a) Specifications. Each milliliter contains 10 milligrams (mg) 
alfaxalone.
    (b) Sponsor. See No. 049480 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in cats and dogs--(1) Amount--(i) Cats--(A) 
Induction of general anesthesia. Administer by intravenous injection 
over approximately 60 seconds or until clinical signs show the onset of 
anesthesia, 2.2 to 9.7 mg/kilogram (kg) for cats that did not receive a 
preanesthetic or 1.0 to 10.8 mg/kg for cats that received a 
preanesthetic.
    (B) Maintenance of general anesthesia following induction. 
Administer an intravenous bolus containing 1.1 to 1.3 mg/kg to provide 
an additional 7 to 8 minutes of anesthesia in preanesthetized cats; a 
dose containing 1.4 to 1.5 mg/kg provides an additional 3 to 5 minutes 
anesthesia in unpreanesthetized cats.
    (ii) Dogs--(A) Induction of general anesthesia. Administer by 
intravenous injection over approximately 60 seconds or until clinical 
signs show the onset of anesthesia, 1.5 to 4.5 mg/kg for dogs that did 
not receive a preanesthetic or 0.2 to 3.5 mg/kg for dogs that received a 
preanesthetic.
    (B) Maintenance of general anesthesia following induction. 
Administer an intravenous bolus containing 1.2 to 1.4 mg/kg to provide 
an additional 6 to 8 minutes of anesthesia in preanesthetized dogs; a 
dose of 1.5 to 2.2 mg/kg provides an additional 6 to 8 minutes of 
anesthesia in unpreanesthetized dogs.
    (2) Indications for use. For the induction and maintenance of 
anesthesia and for induction of anesthesia followed by maintenance with 
an inhalant anesthetic, in dogs and cats.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian. Alfaxalone is a Class IV controlled 
substance.

[77 FR 64717, Oct. 23, 2012, as amended at 79 FR 64116, Oct. 28, 2014]



Sec. 522.56  Amikacin.

    (a) Specifications. Each milliliter of solution contains 50 
milligrams (mg) of amikacin as amikacin sulfate.
    (b) Sponsor. See No. 069043 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in dogs--(1) Amount. 5 mg/pound (lb) of body 
weight twice daily by intramuscular or subcutaneous injection.

[[Page 271]]

    (2) Indications for use. For treatment of genitourinary tract 
infections (cystitis) caused by susceptible strains of Escherichia coli 
and Proteus spp. and skin and soft tissue infections caused by 
susceptible strains of Pseudomonas spp. and E. coli.
    (3) Limitations. Do not use in horses intended for human 
consumption. Federal law restricts this drug to use by or on the order 
of a licensed veterinarian.

[76 FR 17338, Mar. 29, 2011, as amended at 78 FR 17597, Mar. 22, 2013; 
79 FR 16183, Mar. 25, 2014; 81 FR 17608, Mar. 30, 2016]



Sec. 522.62  Aminopentamide.

    (a) Specifications. Each milliliter of solution contains 0.5 
milligram (mg) aminopentamide hydrogen sulfate.
    (b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in dogs and cats--(1) Amount. Administer by 
subcutaneous or intramuscular injection every 8 to 12 hours as follows: 
For animals weighing up to 10 pounds (lbs): 0.1 mg; For animals weighing 
11 to 20 lbs: 0.2 mg; For animals weighing 21 to 50 lbs: 0.3 mg; For 
animals weighing 51 to 100 lbs: 0.4 mg; For animals weighing over 100 
lbs: 0.5 mg. Dosage may be gradually increased up to a maximum of five 
times the suggested dosage. Following parenteral use, dosage may be 
continued by oral administration of tablets.
    (2) Indications for use. For the treatment of vomiting and/or 
diarrhea, nausea, acute abdominal visceral spasm, pylorospasm, or 
hypertrophic gastritis.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[79 FR 16183, Mar. 25, 2014]



Sec. 522.82  Aminopropazine.

    (a) Specifications. Each milliliter of solution contains 
aminopropazine fumarate equivalent to 25 milligrams (mg) aminopropazine 
base.
    (b) Sponsor. See No. 000061 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use--(1) Dogs and cats--(i) Amount. 1 to 2 mg per 
pound of body weight, repeated every 12 hours as indicated, by 
intramuscular or intravenous injection.
    (ii) Indications for use. For reducing excessive smooth muscle 
contractions, such as occur in urethral spasms associated with 
urolithiasis.
    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.
    (2) Horses--(i) Amount. Administer 0.25 mg per pound of body weight, 
repeated every 12 hours as indicated, by intramuscular or intravenous 
injection.
    (ii) Indications for use. For reducing excessive smooth muscle 
contractions, such as occur in colic spasms.
    (iii) Limitations. Do not use in horses intended for human 
consumption. Federal law restricts this drug to use by or on the order 
of a licensed veterinarian.

[79 FR 16183, Mar. 25, 2014]



Sec. 522.88  Amoxicillin.

    (a) Specifications. (1) Each vial contains 3 grams (g) of 
amoxicillin trihydrate. Each milliliter of constituted suspension 
contains 100 or 250 milligrams (mg) amoxicillin trihydrate for use as in 
paragraph (d)(1) of this section.
    (2) Each vial contains 25 g of amoxicillin trihydrate. Each 
milliliter of constituted suspension contains 250 mg amoxicillin 
trihydrate for use as in paragraph (d)(2) of this section.
    (b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
    (c) Related tolerance. See Sec. 556.38 of this chapter.
    (d) Conditions of use--(1) Dogs and cats--(i) Amount. Administer 5 
mg per pound of body weight daily for up to 5 days by intramuscular or 
subcutaneous injection.
    (ii) Indications for use--(A) Dogs. For treatment of infections 
caused by susceptible strains of organisms as follows: Respiratory 
infections (tonsillitis, tracheobronchitis) due to Staphylococcus 
aureus, Streptococcus spp., Escherichia coli, and Proteus mirabilis; 
genitourinary infections (cystitis) due to S. aureus, Streptococcus 
spp., E. coli, and P. mirabilis; gastrointestinal infections (bacterial 
gastroenteritis) due to S. aureus, Streptococcus spp., E. coli, and P. 
mirabilis; bacterial dermatitis due to S. aureus, Streptococcus spp., 
and P. mirabilis; soft tissue infections (abscesses, lacerations, and 
wounds), due to S. aureus, Streptococcus spp., E. coli, and P. 
mirabilis.

[[Page 272]]

    (B) Cats. For treatment of infections caused by susceptible strains 
of organisms as follows: Upper respiratory infections due to S. aureus, 
Staphylococcus spp., Streptococcus spp., Haemophilus spp., E. coli, 
Pasteurella spp., and P. mirabilis; genitourinary infections (cystitis) 
due to S. aureus, Streptococcus spp., E. coli, P. mirabilis, and 
Corynebacterium spp.; gastrointestinal infections due to E. coli, 
Proteus spp., Staphylococcus spp., and Streptococcus spp.; skin and soft 
tissue infections (abscesses, lacerations, and wounds) due to S. aureus, 
Staphylococcus spp., Streptococcus spp., E. coli, and Pasteurella 
multocida.
    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.
    (2) Cattle--(i) Amount. Administer 3 to 5 mg per pound of body 
weight daily for up to 5 days by intramuscular or subcutaneous 
injection.
    (ii) Indications for use. For treatment of diseases due to 
amoxicillin-susceptible organisms as follows: Respiratory tract 
infections (shipping fever, pneumonia) due to P. multocida, P. 
hemolytica, Haemophilus spp., Staphylococcus spp., and Streptococcus 
spp. and acute necrotic pododermatitis (foot rot) due to Fusobacterium 
necrophorum.
    (iii) Limitations. Treated animals must not be slaughtered for food 
during treatment and for 25 days after the last treatment. Milk from 
treated cows must not be used for human consumption during treatment or 
for 96 hours (8 milkings) after last treatment. Federal law restricts 
this drug to use by or on the order of a licensed veterinarian.

[79 FR 16183, Mar. 25, 2014]



Sec. 522.90  Ampicillin injectable dosage forms.

[79 FR 16183, Mar. 25, 2014]



Sec. 522.90a  Ampicillin trihydrate suspension.

    (a) Specifications. (1) Each milliliter contains ampicillin 
trihydrate equivalent to 200 milligrams (mg) of ampicillin.
    (2) Each milliliter contains ampicillin trihydrate equivalent to 150 
mg of ampicillin.
    (b) Sponsors. See sponsor numbers in Sec. 510.600(c) of this 
chapter.
    (1) No. 054771 for use of product described in paragraph (a)(1) as 
in paragraphs (d)(1), (d)(2), (d)(3)(i)(A), (d)(3)(ii)(A), (d)(3)(iii), 
and (d)(4) of this section.
    (2) No. 054771 for use of product described in paragraph (a)(2) as 
in paragraphs (d)(3)(i)(B), (d)(3)(ii)(B), and (d)(3)(iii) of this 
section.
    (c) Related tolerances. See Sec. 556.40 of this chapter.
    (d) Conditions of use--(1) Cattle--(i) Amount. For enteritis: 3 mg 
per pound of body weight, intramuscularly, once or twice daily, for up 
to 3 days. For pneumonia: 3 mg per pound of body weight, 
intramuscularly, twice daily, for up to 3 days.
    (ii) Indications for use. For treatment of bacterial enteritis in 
calves caused by Escherichia coli and bacterial pneumonia caused by 
Pasteurella spp. susceptible to ampicillin.
    (iii) Limitations. Treated animals must not be slaughtered for food 
use during treatment or for 9 days after the last treatment. Federal law 
restricts this drug to use by or on the order of a licensed 
veterinarian.
    (2) Swine--(i) Amount. 3 mg per pound of body weight by 
intramuscular injection, once or twice daily, for up to 3 days.
    (ii) Indications for use. Treatment of bacterial enteritis 
(colibacillosis) caused by E. coli and bacterial pneumonia caused by 
Pasteurella spp. susceptible to ampicillin.
    (iii) Limitations. Treated animals must not be slaughtered for food 
use during treatment or for 15 days after the last treatment. Federal 
law restricts this drug to use by or on the order of a licensed 
veterinarian.
    (3) Dogs--(i) Amount. (A) 3 to 6 mg per pound of body weight by 
intramuscular injection, once or twice daily. Usual treatment is 3 to 5 
days.
    (B) 3 to 5 mg of ampicillin per pound of body weight, once a day for 
up to 4 days.
    (ii) Indications for use. (A) Treatment of respiratory tract 
infections due to E. coli, Pseudomonas spp., Proteus spp., 
Staphylococcus spp., and Streptococcus spp.; tonsillitis due to E. coli, 
Pseudomonas spp., Streptococcus spp.,

[[Page 273]]

and Staphylococcus spp.; generalized infections (septicemia) associated 
with abscesses, lacerations, and wounds due to Staphylococcus spp. and 
Streptococcus spp.
    (B) Treatment of bacterial infections of the upper respiratory tract 
(tonsillitis) due to Streptococcus spp., Staphylococcus spp., E. coli, 
Proteus spp., and Pasteurella spp., and soft tissue infections 
(abscesses, lacerations, and wounds) due to Staphylococcus spp., 
Streptococcus spp., and E. coli, when caused by susceptible organisms.
    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.
    (4) Cats--(i) Amount. 5 to 10 mg per pound of body weight by 
intramuscular or subcutaneous injection, once or twice daily. Usual 
treatment is 3 to 5 days.
    (ii) Indications for use. Treatment of generalized infections 
(septicemia) associated with abscesses, lacerations, and wounds due to 
Staphylococcus spp., Streptococcus spp., and Pasteurella spp.
    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

[79 FR 16183, Mar. 25, 2014]



Sec. 522.90b  Ampicillin trihydrate powder for injection.

    (a) Specifications. Each milliliter of aqueous suspension 
constituted from ampicillin trihydrate powder contains 200, 250, or 400 
milligrams (mg) ampicillin equivalents.
    (b) Sponsors. See Nos. 000010 and 042791 in Sec. 510.600(c) of this 
chapter.
    (c) Related tolerances. See Sec. 556.40 of this chapter.
    (d) Conditions of use--(1) Dogs and cats--(i) Amount. 3 mg/pound 
(lb) of body weight twice daily by subcutaneous or intramuscular 
injection.
    (ii) Indications for use. For treatment of strains of organisms 
susceptible to ampicillin and associated with respiratory tract 
infections, urinary tract infections, gastrointestinal infections, skin 
infections, soft tissue infections, and postsurgical infections.
    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.
    (2) Cattle--(i) Amount. 2 to 5 mg/lb of body weight once daily by 
intramuscular injection.
    (ii) Indications for use. For treatment of respiratory tract 
infections caused by organisms susceptible to ampicillin, bacterial 
pneumonia (shipping fever, calf pneumonia, and bovine pneumonia) caused 
by Aerobacter spp., Klebsiella spp., Staphylococcus spp., Streptococcus 
spp., Pasteurella multocida, and Escherichia coli.
    (iii) Limitations. Do not treat cattle for more than 7 days. Milk 
from treated cows must not be used for food during treatment and for 48 
hours (4 milkings) after the last treatment. Cattle must not be 
slaughtered for food during treatment and for 144 hours (6 days) after 
the last treatment. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[57 FR 37331, Aug. 18, 1992; 57 FR 42623, Sept. 15, 1992; 58 FR 18304, 
Apr. 8, 1993; 63 FR 41420, Aug. 4, 1998; 75 FR 10167, Mar. 5, 2010; 76 
FR 17338, Mar. 29, 2011; 76 FR 53051, Aug. 25, 2011; 82 FR 21690, May 
10, 2017; 85 FR 4208, Jan. 24, 2020]



Sec. 522.90c  Ampicillin sodium.

    (a) Specifications. Each milliliter of aqueous solution constituted 
from ampicillin sodium powder contains 300 milligrams (mg) ampicillin 
equivalents.
    (b) Sponsors. See Nos. 010515 and 054771 in Sec. 510.600(c) of this 
chapter.
    (c) Conditions of use in horses--(1) Amount: 3 mg per pound of body 
weight twice daily by intravenous or intramuscular injection.
    (2) Indications for use. For the treatment of respiratory tract 
infections (pneumonia and strangles) due to Staphylococcus spp., 
Streptococcus spp. (including S. equi), Escherichia coli, and Proteus 
mirabilis, and skin and soft tissue infections (abscesses and wounds) 
due to Staphylococcus spp., Streptococcus spp., E. coli, and P. 
mirabilis, when caused by susceptible organisms.
    (3) Limitations. Do not use in horses intended for human 
consumption. Federal law restricts this drug to use by or on the order 
of a licensed veterinarian.

[72 FR 45158, Aug. 13, 2007, as amended at 79 FR 16184, Mar. 25, 2014]

[[Page 274]]



Sec. 522.144  Arsenamide.

    (a) Specifications. Each milliliter of solution contains 10.0 
milligrams arsenamide sodium.
    (b) Sponsor. See No. 000010 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in dogs--(1) Amount. Administer 0.1 milliliter 
(mL) per pound of body weight (1.0 mL for every 10 pounds) by 
intravenous injection twice a day for 2 days.
    (2) Indications for use. For the treatment and prevention of canine 
heartworm disease caused by Dirofilaria immitis.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[79 FR 16184, Mar. 25, 2014, as amended at 84 FR 39183, Aug. 9, 2019]



Sec. 522.147  Atipamezole.

    (a) Specifications. Each milliliter of solution contains 5.0 
milligrams atipamezole hydrochloride.
    (b) Sponsor. See Nos. 015914 and 052483 in Sec. 510.600(c) of this 
chapter.
    (c) Conditions of use in dogs--(1) Amount. Inject intramuscularly 
the same volume as that of dexmedetomidine or medetomidine used.
    (2) Indications for use. For reversal of the sedative and analgesic 
effects of dexmedetomidine hydrochloride or medetomidine hydrochloride.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[61 FR 48830, Sept. 17, 1996, as amended at 64 FR 71640, Dec. 22, 1999; 
72 FR 264, Jan. 4, 2007; 84 FR 8973, Mar. 13, 2019]



Sec. 522.150  Azaperone.

    (a) Specifications. Each milliliter of solution contains 40 
milligrams (mg) azaperone.
    (b) Sponsor. See No. 058198 in Sec. 510.600(c) of this chapter.
    (c) Related tolerances. See Sec. 556.68 of this chapter.
    (d) Conditions of use--(1) Indications for use. For control of 
aggressiveness when mixing or regrouping weanling or feeder pigs 
weighing up to 80 pounds.
    (2) Dosage. 2.2 mg per kilogram (1 mg per pound) by deep 
intramuscular injection.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[74 FR 65689, Dec. 11, 2009, as amended at 77 FR 46613, Aug. 6, 2012; 81 
FR 48702, July 26, 2016; 84 FR 32992, July 11, 2019]



Sec. 522.161  Betamethasone.

    (a) Specifications. Each milliliter of suspension contains:
    (1) Betamethasone acetate equivalent to 10.8 milligrams (mg) 
betamethasone and betamethasone disodium phosphate equivalent to 3 mg of 
betamethasone.
    (2) Betamethasone dipropionate equivalent to 5 mg betamethasone and 
betamethasone sodium phosphate equivalent to 2 mg of betamethasone.
    (b) Sponsor. See sponsor numbers in Sec. 510.600(c) of this 
chapter:
    (1) No. 000061 for product described in paragraph (a)(1) of this 
section for use as in paragraphs (c)(1), (c)(2)(i), (c)(2)(ii)(A), and 
(c)(2)(iii) of this section.
    (2) No. 000061 for product described in paragraph (a)(2) of this 
section for use as in paragraphs (c)(1), (c)(2)(i), (c)(2)(ii)(B), and 
(c)(2)(iii) of this section.
    (c) Conditions of use--(1) Dogs--(i) Amount. Administer by 
intramuscular injection 0.25 to 0.5 milliliter (mL) per 20 pounds of 
body weight, depending on the severity of the condition. Frequency of 
dosage depends on recurrence of pruritic symptoms. Dosage may be 
repeated every 3 weeks or when symptoms recur, not to exceed a total of 
four injections.
    (ii) Indications for use. As an aid in the control of pruritus 
associated with dermatoses.
    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.
    (2) Horses--(i) Amount. Administer 2.5 to 5 mL by intra-articular 
injection.
    (ii) Indications for use. (A) For the treatment of various 
inflammatory joint conditions; for example, acute and traumatic lameness 
involving the carpel and fetlock joints.
    (B) As an aid in the control of inflammation associated with various 
arthropathies.

[[Page 275]]

    (iii) Limitations. Do not use in horses intended for human 
consumption. Federal law restricts this drug to use by or on the order 
of a licensed veterinarian.

[79 FR 16184, Mar. 25, 2014]



Sec. 522.163  Betamethasone dipropionate and betamethasone sodium
phosphate aqueous suspension.

    (a) Specifications. Betamethasone dipropionate and betamethasone 
sodium phosphate aqueous suspension is a sterile aqueous suspension. 
Each milliliter of the suspension contains the equivalent of 5 
milligrams of betamethasone as betamethasone dipropionate and 2 
milligrams of betamethasone as betamethasone sodium phosphate.
    (b) Sponsor. See No. 000061 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use--(1) Dogs. (i) It is used as an aid in the 
control of pruritus associated with dermatoses.
    (ii) It is administered by intramuscular injection at a dosage of 
0.25 to 0.5 milliliter per 20 pounds of body weight, depending on the 
severity of the condition. Frequency of dosage depends on recurrence of 
pruritic symptoms. Dosage may be repeated every 3 weeks or when symptoms 
recur, not to exceed a total of 4 injections.
    (2) Horses. (i) It is used as an aid in the control of inflammation 
associated with various arthropathies.
    (ii) It is administered aseptically by intraarticular injection at a 
dosage of 2.5 to 5 milliliters per joint, depending on the severity of 
the condition and the joint size. Dosage may be repeated upon recurrence 
of clinical signs. Injection into the joint cavity should be preceded by 
withdrawal of synovial fluid.
    (iii) Not for use in horses intended for food.
    (3) Clinical and experimental data. It has been demonstrated that 
corticosteroids administered orally or parenterally to animals may 
induce the first stage of parturition when administered during the last 
trimester of pregnancy and may precipitate premature parturition 
followed by dystocia, fetal death, retained placenta, and metritis.
    (4) Restrictions. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

[40 FR 13858, Mar. 27, 1975, as amended at 41 FR 27316, July 2, 1976; 52 
FR 7832, Mar. 13, 1987]



Sec. 522.167  Betamethasone sodium phosphate and betamethasone
acetate.

    (a) Specifications. Each milliliter (mL) of suspension contains 6 
milligrams (mg) betamethasone (3.15 mg betamethasone sodium phosphate 
and 2.85 mg betamethasone acetate).
    (b) Sponsor. See No. 010797 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in horses--(1) Amount. Administer 1.5 mL (9 mg 
total betamethasone) per joint by intra-articular injection. May be 
administered concurrently in up to two joints per horse.
    (2) Indications for use. For the control of pain and inflammation 
associated with osteoarthritis in horses.
    (3) Limitations. Do not use in horses intended for human 
consumption. Federal law restricts this drug to use by or on the order 
of a licensed veterinarian.

[80 FR 18776, Apr. 8, 2015]



Sec. 522.204  Boldenone.

    (a) Specifications. Each milliliter of solution contains 25 or 50 
milligrams (mg) boldenone undecylenate.
    (b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in horses--(1) Amount. 0.5 mg per pound body 
weight by intramuscular injection. Treatment may be repeated at 3-week 
intervals.
    (2) Indications for use. As an aid for treating debilitated horses 
when an improvement in weight, hair coat, or general physical condition 
is desired.
    (3) Limitations. Do not administer to horses intended for human 
consumption. Federal law restricts this drug to use by or on the order 
of a licensed veterinarian.

[70 FR 70998, Nov. 25, 2005, as amended at 79 FR 16184, Mar. 25, 2014]



Sec. 522.224  Bupivacaine.

    (a) Specifications. Each milliliter (mL) of liposomal suspension 
contains 13.3 milligrams (mg) bupivacaine.

[[Page 276]]

    (b) Sponsor. See No. 058198 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use--(1) Dogs--(i) Amount. Administer 5.3 mg/kg 
(0.4 mL/kg) by infiltration injection into the tissue layers at the time 
of incisional closure.
    (ii) Indications for use. For single-dose infiltration into the 
surgical site to provide local postoperative analgesia for cranial 
cruciate ligament surgery.
    (2) Cats--(i) Amount. Administer 5.3 mg/kg per forelimb (0.4 mL/kg 
per forelimb), for a total dose of 10.6 mg/kg/cat, as a 4-point nerve 
block prior to onychectomy.
    (ii) Indications for use. For use as a peripheral nerve block to 
provide regional postoperative analgesia following onychectomy.

[81 FR 67151, Sept. 30, 2016, as amended at 84 FR 8973, Mar. 13, 2019; 
85 FR 4208, Jan. 24, 2020]



Sec. 522.230  Buprenorphine.

    (a) Specifications. Each milliliter of solution contains 1.8 
milligrams (mg) buprenorphine.
    (b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in cats--(1) Amount. Administer 0.24 mg per 
kilogram (0.11 mg per pound) by subcutaneous injection once daily, for 
up to 3 days. Administer the first dose approximately 1 hour prior to 
surgery.
    (2) Indications for use. For the control of postoperative pain 
associated with surgical procedures in cats.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[79 FR 53136, Sept. 8, 2014, as amended at 80 FR 18776, Apr. 8, 2015]



Sec. 522.234  Butamisole.

    (a) Specifications. Each milliliter of solution contains 11 
milligrams (mg) butamisole hydrochloride.
    (b) Sponsors. See Nos. 054771 and 058198 in Sec. 510.600(c) of this 
chapter.
    (c) Conditions of use in dogs--(1) Amount. Administer 0.1 mg per 
pound of body weight by subcutaneous injection. In problem cases, 
retreatment for whipworms may be necessary in approximately 3 months. 
For hookworms, a second injection should be given 21 days after the 
initial treatment.
    (2) Indications for use. For the treatment of infections with 
whipworms (Trichuris vulpis), and the hookworm (Ancylostoma caninum).
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[79 FR 16184, Mar. 25, 2014, as amended at 86 FR 14819, Mar. 19, 2021]



Sec. 522.246  Butorphanol.

    (a) Specifications. Each milliliter of solution contains butorphanol 
(as butorphanol tartrate) in the following amounts:
    (1) 0.5 milligrams (mg);
    (2) 2 mg; or
    (3) 10 mg
    (b) Sponsors. See sponsors in Sec. 510.600(c) of this chapter as 
follows:
    (1) No. 054771 for use of the product described in paragraph (a)(1) 
as in paragraph (d)(1) of this section; for use of the product described 
in paragraph (a)(2) as in paragraph (d)(2) of this section; and for use 
of the product described in paragraph (a)(3) as in paragraph (d)(3) of 
this section.
    (2) No. 058198 for use of the product described in paragraph (a)(2) 
of this section as in paragraph (d)(2) of this section.
    (3) Nos. 000061, 058198, and 059399 for use of the product described 
in paragraph (a)(3) of this section as in paragraph (d)(3) of this 
section.
    (c) Special considerations. Federal law restricts this drug to use 
by or on the order of a licensed veterinarian.
    (d) Conditions of use--(1) Dogs--(i) Amount. Administer 0.025 mg per 
pound of body weight by subcutaneous injection at intervals of 6 to 12 
hours, as required. If necessary, increase dose to a maximum of 0.05 mg 
per pound of body weight. Treatment should not normally be required for 
longer than 7 days.
    (ii) Indications for use. For the relief of chronic nonproductive 
cough associated with tracheo-bronchitis, tracheitis, tonsillitis, 
laryngitis, and pharyngitis associated with inflammatory conditions of 
the upper respiratory tract.

[[Page 277]]

    (2) Cats--(i) Amount. Administer 0.2 mg per pound of body weight by 
subcutaneous injection. Dose may be repeated up to 4 times per day. Do 
not treat for more than 2 days.
    (ii) Indications for use. For the relief of pain in cats caused by 
major or minor trauma, or pain associated with surgical procedures.
    (3) Horses--(i) Amount. Administer 0.05 mg per pound of body weight 
by intravenous injection. Dose may be repeated within 3 to 4 hours. 
Treatment should not exceed 48 hours.
    (ii) Indications for use. For the relief of pain associated with 
colic and postpartum pain in adult horses and yearlings.
    (iii) Limitations. Do not use in horses intended for human 
consumption.

[72 FR 27957, May 18, 2007, as amended at 73 FR 31358, June 2, 2008; 74 
FR 61516, Nov. 25, 2009; 75 FR 22524, Apr. 29, 2010; 77 FR 60302, Oct. 
3, 2012; 78 FR 17597, Mar. 22, 2013; 79 FR 16184, Mar. 25, 2014; 79 FR 
74020, Dec. 15, 2014; 80 FR 13229, Mar. 13, 2015; 86 FR 14819, Mar. 19, 
2021]



Sec. 522.275  N-Butylscopolammonium.

    (a) Specifications. Each milliliter of solution contains 20 
milligrams (mg) N-butylscopolammonium bromide.
    (b) Sponsor. See No. 000010 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in horses--(1) Amount. 0.3 mg per kilogram of 
body weight (0.14 mg per pound) slowly intravenously.
    (2) Indications for use. For the control of abdominal pain (colic) 
associated with spasmodic colic, flatulent colic, and simple impactions.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[69 FR 35512, June 25, 2004]



Sec. 522.304  Carprofen.

    (a) Specifications. Each milliliter of solution contains 50 
milligrams (mg) carprofen.
    (b) Sponsors. See Nos. 016729, 026637, 054771, and 055529 in Sec. 
510.600(c) of this chapter.
    (c) [Reserved]
    (d) Conditions of use in dogs--(1) Amount. 2 mg/lb (4.4 mg/kg) body 
weight once daily or 1 mg/lb (2.2 mg/kg) twice daily, by subcutaneous 
injection. For the control of postoperative pain, administer 
approximately 2 hours before the procedure.
    (2) Conditions of use. For the relief of pain and inflammation 
associated with osteoarthritis and for the control of postoperative pain 
associated with soft tissue and orthopedic surgeries.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[68 FR 26205, May 15, 2003, as amended at 68 FR 34796, June 11, 2003; 68 
FR 49351, Aug. 18, 2003. Redesignated at 73 FR 29685, May 22, 2008, as 
amended at 79 FR 74020, Dec. 15, 2014; 82 FR 43484, Sept. 18, 2017]



Sec. 522.311  Cefovecin.

    (a) Specifications. Each milliliter of constituted solution contains 
80 milligrams (mg) cefovecin as the sodium salt.
    (b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
    (c) Special considerations. Federal law restricts this drug to use 
by or on the order of a licensed veterinarian.
    (d) Conditions of use--(1) Dogs--(i) Amount. Administer 3.6 mg/pound 
(lb) (8 mg/kilograms (kg)) body weight as a single subcutaneous 
injection. A second subcutaneous injection of 3.6 mg/lb (8 mg/kg) may be 
administered if response to therapy is not complete.
    (ii) Indications for use. For the treatment of skin infections 
(secondary superficial pyoderma, abscesses, and wounds) in dogs caused 
by susceptible strains of Staphylococcus intermedius and Streptococcus 
canis (Group G).
    (2) Cats--(i) Amount. Administer 3.6 mg/lb (8 mg/kg) body weight as 
a single, one-time subcutaneous injection.
    (ii) Indications for use. For the treatment of skin infections 
(wounds and abscesses) in cats caused by susceptible strains of 
Pasteurella multocida.

[73 FR 29685, May 22, 2008, as amended at 79 FR 16185, Mar. 25, 2014]



Sec. 522.313  Ceftiofur injectable dosage forms.



Sec. 522.313a  Ceftiofur crystalline free acid.

    (a) Specifications. The product is a suspension of ceftiofur 
crystalline free acid.

[[Page 278]]

    (1) Each milliliter (mL) contains 100 milligrams (mg) ceftiofur 
equivalents.
    (2) Each mL contains 200 mg ceftiofur equivalents.
    (b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
    (c) Related tolerances. See Sec. 556.113 of this chapter.
    (d) Conditions of use--(1) Swine. The formulation described in 
paragraph (a)(1) of this section is used as follows:
    (i) Amount. 5.0 mg CE per kilogram (kg) of body weight by 
intramuscular injection in the postauricular region of the neck.
    (ii) Indications for use. For the treatment of swine respiratory 
disease (SRD) associated with Actinobacillus pleuropneumoniae, 
Pasteurella multocida, Haemophilus parasuis, and Streptococcus suis. For 
the control of SRD associated with A. pleuropneumoniae, P. multocida, H. 
parasuis, and S. suis in groups of pigs where SRD has been diagnosed.
    (iii) Limitations. Following label use as a single treatment, a 14-
day pre-slaughter withdrawal period is required. Federal law restricts 
this drug to use by or on the order of a licensed veterinarian. Federal 
law prohibits extra-label use of this drug in swine for disease 
prevention purposes; at unapproved doses, frequencies, durations, or 
routes of administration; and in unapproved, major food-producing 
species/production classes.
    (2) Cattle. The formulation described in paragraph (a)(2) of this 
section is used as follows:
    (i) Amount. For subcutaneous (SC) injection in the posterior aspect 
of the ear where it attaches to the head (base of the ear) in lactating 
dairy cattle. For SC injection in the middle third of the posterior 
aspect of the ear or in the base of the ear in beef and non-lactating 
dairy cattle.
    (A) Single-dose regimen: 6.6 mg ceftiofur equivalents per kg of body 
weight as a single injection.
    (B) Two-dose regimen: 6.6 mg ceftiofur equivalents per kg of body 
weight given as two injections in the base of the ear approximately 72 
hours apart.
    (ii) Indications for use. (A) Single-dose regimen: For the treatment 
of bovine respiratory disease (BRD, shipping fever, pneumonia) 
associated with Mannheimia haemolytica, Pasteurella multocida, and 
Histophilus somni in beef, non-lactating dairy, and lactating dairy 
cattle. For the control of respiratory disease in beef and non-lactating 
dairy cattle which are at high risk of developing BRD associated with M. 
haemolytica, P. multocida, and H. somni. For the treatment of bovine 
foot rot (interdigital necrobacillosis) associated with Fusobacterium 
necrophorum and Porphyromonas levii in beef, non-lactating dairy, and 
lactating dairy cattle.
    (B) Two-dose regimen: For the treatment of acute metritis (0-to 10-
days postpartum) associated with bacterial organisms susceptible to 
ceftiofur in lactating dairy cattle.
    (iii) Limitations. Following label use as either a single-dose or 2-
dose regimen, a 13-day pre-slaughter withdrawal period is required after 
the last treatment. A withdrawal period has not been established in 
preruminating calves. Do not use in calves to be processed for veal. 
Federal law restricts this drug to use by or on the order of a licensed 
veterinarian. Federal law prohibits extra-label use of this drug in 
cattle for disease prevention purposes; at unapproved doses, 
frequencies, durations, or routes of administration; and in unapproved, 
major food-producing species/production classes.
    (3) Horses. The formulation described in paragraph (a)(2) of this 
section is used as follows:
    (i) Amount. Two intramuscular injections, 4 days apart, at a dose of 
3.0 mg/lb (6.6 mg/kg) body weight.
    (ii) Indications for use. For the treatment of lower respiratory 
tract infections in horses caused by susceptible strains of 
Streptococcus equi ssp. zooepidemicus.
    (iii) Limitations. Do not use in horses intended for human 
consumption. Federal law restricts this drug to use by or on the order 
of a licensed veterinarian.

[68 FR 60296, Oct. 22, 2003, as amended at 69 FR 43892, July 23, 2004. 
Redesignated and amended at 71 FR 39546, July 13, 2006; 73 FR 58872, 
Oct. 8, 2008; 75 FR 4692, Jan. 29, 2010; 75 FR 62468, Oct. 12, 2010; 77 
FR 26162, May 3, 2012; 79 FR 16185, Mar. 25, 2014; 79 FR 37620, July 2, 
2014]

[[Page 279]]



Sec. 522.313b  Ceftiofur hydrochloride.

    (a) Specifications. Each milliliter of suspension contains:
    (1) Ceftiofur hydrochloride equivalent to 50 milligrams (mg) of 
ceftiofur equivalents in the inactive vehicles phospholipan 90H, 
sorbitan monooleate, and cottonseed oil;
    (2) Ceftiofur hydrochloride equivalent to 50 mg ceftiofur 
equivalents in the inactive vehicles polyoxyethylene sorbitan monooleate 
(polysorbate 80) in a caprylic/capric triglyceride suspension; or
    (3) Ceftiofur hydrochloride equivalent to 50 mg ceftiofur 
equivalents in the inactive vehicles aluminum monostearate, sorbitan 
monooleate, and medium chain triglycerides.
    (b) Sponsors. See sponsors in Sec. 510.600(c) of this chapter as 
follows:
    (1) No. 054771 for products described in paragraphs (a)(1) and (2) 
of this section; and
    (2) No. 055529 for the product described in paragraph (a)(3) of this 
section.
    (c) Related tolerances. See Sec. 556.113 of this chapter.
    (d) Special considerations. Federal law restricts this drug to use 
by or on the order of a licensed veterinarian. Federal law prohibits 
extra-label use of this drug in cattle and swine for disease prevention 
purposes; at unapproved doses, frequencies, durations, or routes of 
administration; and in unapproved major food-producing species/
production classes.
    (e) Conditions of use--(1) Swine--(i) Amount. 3 to 5 mg per kilogram 
(/kg) of body weight by intramuscular injection. Treatment should be 
repeated at 24-hour intervals for a total of 3 consecutive days.
    (ii) Indications for use. For treatment and control of swine 
bacterial respiratory disease (swine bacterial pneumonia) associated 
with Actinobacillus pleuropneumoniae, Pasteurella multocida, Salmonella 
Choleraesuis, and Streptococcus suis.
    (iii) Limitations. For products described in paragraphs (a)(1) and 
(3) of this section: Treated swine must not be slaughtered for 4 days 
following the last treatment. For products described in paragraph (a)(2) 
of this section: Treated swine must not be slaughtered for 6 days 
following the last treatment when injection site volumes are greater 
than 5 mL up to the maximum injection site volume of 15 mL. Treated 
swine must not be slaughtered for 4 days when injection site volumes are 
less than or equal to 5 mL.
    (2) Cattle--(i) Amount. Administer by subcutaneous or intramuscular 
injection as follows:
    (A) For bovine respiratory disease and acute bovine interdigital 
necrobacillosis: 1.1 to 2.2 mg/kg of body weight at 24-hour intervals 
for 3 to 5 consecutive days.
    (B) For bovine respiratory disease: 2.2 mg/kg of body weight 
administered twice at a 48 hour interval.
    (C) For acute metritis: 2.2 mg/kg of body weight at 24-hour 
intervals for 5 consecutive days.
    (ii) Indications for use. For treatment of bovine respiratory 
disease (BRD, shipping fever, pneumonia) associated with Mannheimia 
haemolytica, P. multocida, and Histophilus somni; acute bovine 
interdigital necrobacillosis (foot rot, pododermatitis) associated with 
Fusobacterium necrophorum and Bacteroides melaninogenicus; and acute 
metritis (0 to 14 days post-partum) associated with bacteria susceptible 
to ceftiofur.
    (iii) Limitations. (A) For products described in paragraphs (a)(2) 
and (3) of this section: Treated cattle must not be slaughtered for 3 
days following the last treatment. For products described in paragraph 
(a)(2) of this section: Treated cattle must not be slaughtered for 4 
days following the last treatment.
    (B) A withdrawal period has not been established in preruminating 
calves. Do not use in calves to be processed for veal.

[61 FR 29479, June 11, 1996, as amended at 63 FR 53578, Oct. 6, 1998; 67 
FR 45901, July 11, 2002; 69 FR 47362, Aug. 5, 2004. Redesignated and 
amended at 71 FR 39544, July 13, 2006; 73 FR 45612, Aug. 6, 2008; 76 FR 
17338, Mar. 29, 2011; 78 FR 66264, Nov. 5, 2013; 84 FR 39183, Aug. 9, 
2019; 84 FR 53311, Oct. 7, 2019]



Sec. 522.313c  Ceftiofur sodium.

    (a) Specifications. Each milliliter of aqueous solution constituted 
from ceftiofur sodium powder contains 50 milligrams (mg) ceftiofur 
equivalents.

[[Page 280]]

    (b) Sponsors. See Nos. 054771 and 068330 in Sec. 510.600(c) of this 
chapter.
    (c) Related tolerances. See Sec. 556.113 of this chapter.
    (d) Special considerations. Federal law restricts this drug to use 
by or on the order of a licensed veterinarian. Federal law prohibits 
extra-label use of this drug in cattle, swine, chickens, and turkeys for 
disease prevention purposes; at unapproved doses, frequencies, 
durations, or routes of administration; and in unapproved major food-
producing species/production classes.
    (e) Conditions of use--(1) Swine--(i) Amount. 3 to 5 mg per kilogram 
(/kg) body weight by intramuscular injection for 3 consecutive days.
    (ii) Indications for use. For treatment and control of swine 
bacterial respiratory disease (swine bacterial pneumonia) associated 
with Actinobacillus pleuropneumoniae, Pasteurella multocida, Salmonella 
choleraesuis, and Streptococcus suis.
    (iii) Limitations. Treated pigs must not be slaughtered for 4 days 
following the last treatment.
    (2) Cattle--(i) Amount. 0.5 to 1.0 mg/lb body weight by 
intramuscular or subcutaneous injection for 3 days. Additional 
treatments may be given on days 4 and 5 for animals which do not show 
satisfactory response.
    (ii) Indications for use. For treatment of bovine respiratory 
disease (shipping fever, pneumonia) associated with Mannheimia 
haemolytica, Pasteurella multocida, and Histophilus somni. Also, for the 
treatment of acute bovine interdigital necrobacillosis (foot rot, 
pododermatitis) associated with Fusobacterium necrophorum and 
Bacteroides melaninogenicus.
    (iii) Limitations. Treated cattle must not be slaughtered for 4 days 
following the last treatment.
    (3) Sheep--(i) Amount. 0.5 to 1.0 mg/lb body weight by intramuscular 
injection for 3 days. Additional treatments may be given on days 4 and 5 
for animals which do not show satisfactory response.
    (ii) Indications for use. For treatment of sheep respiratory disease 
(sheep pneumonia) associated with Mannheimia haemolytica and Pasteurella 
multocida.
    (4) Goats--(i) Amount. 0.5 to 1.0 mg/lb body weight by intramuscular 
injection for 3 days. Additional treatments may be given on days 4 and 5 
for animals which do not show satisfactory response.
    (ii) Indications for use. For treatment of caprine respiratory 
disease (goat pneumonia) associated with Mannheimia haemolytica and 
Pasteurella multocida.
    (5) Chickens--(i) Amount. 0.08 to 0.20 mg as a single subcutaneous 
injection in the neck.
    (ii) Indications for use. For control of early mortality associated 
with Escherichia coli organisms susceptible to ceftiofur in day-old 
chicks.
    (6) Turkeys--(i) Amount. 0.17 to 0.5 mg as a single subcutaneous 
injection in the neck.
    (ii) Indications for use. For control of early mortality associated 
with E. coli organisms susceptible to ceftiofur in day-old poults.
    (7) Horses--(i) Amount. 2.2 to 4.4 mg/kg (1.0 to 2.0 mg/lb) body 
weight by intramuscular injection. Treatment should be repeated every 24 
hours, continued for 48 hours after clinical signs have disappeared, and 
should not exceed 10 days. A maximum of 10 mL should be administered per 
injection site.
    (ii) Indications for use. For treatment of respiratory infections in 
horses associated with Streptococcus zooepidemicus.
    (iii) Limitations. Do not use in horses intended for human 
consumption.
    (8) Dogs--(i) Amount. 1.0 mg/lb (2.2 mg/kg) body weight by 
subcutaneous injection. Treatment should be repeated at 24-hour 
intervals for 5 to 14 days.
    (ii) Indications for use. For treatment of canine urinary tract 
infections associated with E. coli and Proteus mirabilis.

[53 FR 5369, Feb. 24, 1988, as amended at 55 FR 13768, Apr. 12, 1990; 56 
FR 12119, Mar. 22, 1991; 57 FR 41862, Sept. 14, 1992; 59 FR 41666, Aug. 
15, 1994; 59 FR 54518, Nov. 1, 1994; 60 FR 51719, Oct. 3, 1995; 61 FR 
35130, July 5, 1996; 61 FR 66583, Dec. 18, 1996; 66 FR 21283, Apr. 30, 
2001; 66 FR 32540, June 15, 2001; 69 FR 47362, Aug. 5, 2004. 
Redesignated and amended at 71 FR 39544, July 13, 2006; 74 FR 34236, 
July 15, 2009; 77 FR 29218, May 17, 2012; 79 FR 16185, Mar. 25, 2014; 79 
FR 21127, Apr. 15, 2014; 82 FR 12169, Mar. 1, 2017]

[[Page 281]]



Sec. 522.380  Chloral hydrate, pentobarbital, and magnesium sulfate.

    (a) Specifications. Each milliliter of solution contains 42.5 
milligrams (mg) of chloral hydrate, 8.86 mg of pentobarbital, and 21.2 
mg of magnesium sulfate.
    (b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use--(1) Amount. For general anesthesia: 
Administer 20 to 50 milliliters per 100 pounds of body weight by 
intravenous injection until the desired effect is produced. Cattle 
usually require a lower dosage on the basis of body weight. As a 
sedative-relaxant: Administer at a level of one-fourth to one-half of 
the anesthetic dosage level.
    (2) Indications for use. For general anesthesia and as a sedative-
relaxant in cattle and horses.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[79 FR 16185, Mar. 25, 2014]



Sec. 522.390  Chloramphenicol.

    (a) Specifications. Each milliliter of solution contains 100 
milligrams of chloramphenicol.
    (b) Sponsor. See Nos. 054771 and 069043 in Sec. 510.600(c) of this 
chapter.
    (c) Conditions of use. Dogs--(1) Amount. 5 to 15 milligrams per 
pound of body weight, intramuscularly or intravenously, every 6 hours. 
In severe infections, use 4 to 6 hour treatment intervals the first day. 
If no response is obtained in 3 to 5 days, discontinue use and 
reevaluate diagnosis.
    (2) Indications for use. Treatment of infections of the respiratory 
tract, the urinary tract, and enteritis and tonsillitis caused by 
organisms susceptible to chloramphenicol.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian. Federal law prohibits the extralabel 
use of this drug in food-producing animals.

[57 FR 37331, Aug. 18, 1992, as amended at 65 FR 45877, July 26, 2000; 
78 FR 17597, Mar. 22, 2013; 79 FR 16185, Mar. 25, 2014; 81 FR 17608, 
Mar. 30, 2016]



Sec. 522.454  Clodronate.

    (a) Specifications. Each milliliter of solution contains 60 
milligrams (mg) clodronate disodium.
    (b) Sponsor. See No. 043264 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in horses--(1) Amount. Administer 1.8 mg per 
kilogram of body weight by intramuscular injection up to a maximum dose 
of 900 mg per horse.
    (2) Indications for use. For the control of clinical signs 
associated with navicular syndrome.
    (3) Limitations. Do not use in horses intended for human 
consumption. Federal law restricts this drug to use by or on the order 
of a licensed veterinarian.

[79 FR 37620, July 2, 2014]



Sec. 522.460  Cloprostenol.

    (a) Specifications. Each milliliter of solution contains 
cloprostenol sodium equivalent to:
    (1) 125 micrograms ([micro]g) of cloprostenol; or
    (2) 250 [micro]g of cloprostenol.
    (b) Sponsors. See sponsors in Sec. 510.600(c) of this chapter.
    (1) No. 000061 for use of product described in paragraph (a)(1) of 
this section as in paragraphs (c)(1)(i) and (c)(2) of this section.
    (2) Nos. 000061 and 068504 for use of product described in paragraph 
(a)(2) as in paragraphs (c)(1)(ii), (c)(1)(iii), and (c)(2) of this 
section.
    (3) No. 000061 for use of product described in paragraph (a)(2) as 
in paragraphs (c)(1)(iv) and (c)(2) of this section.
    (c) Conditions of use in cattle--(1) Amount and indications for use. 
(i) Administer 375 [micro]g by intramuscular injection to induce 
abortion in pregnant feedlot heifers from 1 week after mating until 4\1/
2\ months of gestation.
    (ii) Administer 500 [micro]g by intramuscular injection for abortion 
of unwanted pregnancies from mismatings from 1 week after mating until 5 
months after conception; for unobserved (non-detected) estrus; for 
treatment of mummified fetus, luteal cysts, and pyometra or chronic 
endometritis in beef cows, lactating dairy cows, and replacement beef 
and dairy heifers.

[[Page 282]]

    (iii) Administer 500 [micro]g by intramuscular injection as a single 
injection regimen or double injection regimen with a second injection 11 
days after the first, for estrus synchronization in beef cows, lactating 
dairy cows, and replacement beef and dairy heifers.
    (iv) For use with gonadorelin acetate to synchronize estrous cycles 
to allow for fixed time artificial insemination (FTAI) in lactating 
dairy cows: Administer to each cow 86 [micro]g gonadorelin by 
intramuscular injection, followed 6 to 8 days later by 500 [micro]g 
cloprostenol by intramuscular injection, followed 30 to 72 hours later 
by 86 [micro]g gonadorelin by intramuscular injection.
    (2) Limitations. Gonadorelin acetate for use in paragraph (c)(1)(iv) 
of this section as provided by No. 000061 in Sec. 510.600(c) of this 
chapter.

[79 FR 16185, Mar. 25, 2014, as amended at 85 FR 4208, Jan. 24, 2020]



Sec. 522.468  Colistimethate sodium powder for injection.

    (a) Specifications. Each vial contains colistimethate sodium 
equivalent to 10 grams colistin activity and mannitol to be 
reconstituted with 62.5 milliliters sterile saline or sterile water for 
injection. The resulting solution contains colistimethate sodium 
equivalent to 133 milligrams per milliliter colistin activity.
    (b) Sponsor. See 054771 in Sec. 510.600(c) of this chapter.
    (c) Related tolerances. See Sec. 556.167 of this chapter.
    (d) Conditions of use. (1) 1- to 3-day-old chickens.
    (i) Dosage. 0.2 milligram colistin activity per chicken.
    (ii) Indications for use. Control of early mortality associated with 
Escherichia coli organisms susceptible to colistin.
    (iii) Limitations. For subcutaneous injection in the neck of 1- to 
3-day-old chickens. Not for use in laying hens producing eggs for human 
consumption. Do not use in turkeys. Federal law restricts this drug to 
use by or on the order of a licensed veterinarian.
    (2) [Reserved]

[63 FR 13123, Mar. 18, 1998, as amended at 79 FR 16185, Mar. 25, 2014; 
84 FR 32992, July 11, 2019]



Sec. 522.480  Corticotropin.

    (a) Specifications. Each milliliter of aqueous solution contains 40 
or 80 U.S.P. (I.U.) units of repository corticotropin.
    (b) Sponsor. See sponsors in Sec. 510.600(c) of this chapter.
    (1) No. 061133 for use as in paragraphs (c)(1) and (2) of this 
section.
    (2) No. 043264 for use as in paragraph (c)(2) and (3) of this 
section.
    (c) Conditions of use--(1) Dogs--(i) Amount. Administer one unit per 
pound of body weight by intramuscular injection.
    (ii) Indications for use. As a diagnostic aid to test for adrenal 
dysfunction.
    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.
    (2) Dogs and cats--(i) Amount. Administer one unit per pound of body 
weight by intramuscular or subcutaneous injection, to be repeated as 
indicated.
    (ii) Indications for use. For stimulation of the adrenal cortex 
where there is a general deficiency of corticotropin (ACTH).
    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.
    (3) Cattle--(i) Amount. Administer 200 to 600 units by intramuscular 
or subcutaneous injection as an initial dose, followed by a dose daily 
or every other day of 200 to 300 units.
    (ii) Indications for use. As a therapeutic agent for primary bovine 
ketosis; and for stimulation of the adrenal cortex where there is a 
general deficiency of ACTH.
    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

[79 FR 16185, Mar. 25, 2014, as amended at 84 FR 8973, Mar. 13, 2019; 85 
FR 45308, July 28, 2020]



Sec. 522.522  Danofloxacin.

    (a) Specifications. Each milliliter of solution contains 180 
milligrams (mg) danofloxacin as the mesylate salt.
    (b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
    (c) Related tolerances. See Sec. 556.169 of this chapter.
    (d) Conditions of use in cattle--(1) Amount and indications for use. 
Administer by subcutaneous injection either:

[[Page 283]]

    (i) 6 mg per kilogram (/kg) of body weight, repeated in 48 hours, 
for the treatment of bovine respiratory disease (BRD) associated with 
Mannheimia haemolytica and Pasteurella multocida; or
    (ii) 8 mg/kg of body weight as a single dose for the treatment of 
BRD associated with M. haemolytica and P. multocida and for the control 
of BRD in beef cattle at high risk of developing BRD associated with M. 
haemolytica and P. multocida.
    (2) Limitations. Animals intended for human consumption should not 
be slaughtered within 4 days from the last treatment. Do not use in 
cattle intended for dairy production. A withdrawal period has not been 
established for this product in pre-ruminating calves. Do not use in 
calves to be processed for veal. Federal law restricts this drug to use 
by or on the order of a licensed veterinarian. Federal law prohibits the 
extra-label use of this drug in food-producing animals.

[67 FR 78972, Dec. 27, 2002, as amended at 77 FR 4227, Jan. 27, 2012; 79 
FR 16185, Mar. 25, 2014; 79 FR 53136, Sept. 8, 2014]



Sec. 522.533  Deslorelin.

    (a) Specifications. (1) Each implant contains 2.1 milligrams (mg) 
deslorelin acetate.
    (2) Each milliliter (mL) of suspension contains 1.8 mg deslorelin 
acetate.
    (b) Sponsors. See sponsor numbers in Sec. 510.600(c) of this 
chapter as follows:
    (1) No. 051311 for use of product described in paragraph (a)(1) as 
in paragraph (c)(1) of this section.
    (2) No. 051330 for use of product described in paragraph (a)(2) as 
in paragraph (c)(2) of this section.
    (c) Conditions of use--(1) Horses and ponies--(i) Amount. One 
implant per mare subcutaneously in the neck.
    (ii) Indications for use. For inducing ovulation within 48 hours in 
estrous mares with an ovarian follicle greater than 30 mL in diameter.
    (iii) Limitations. Do not use in horses or ponies intended for human 
consumption. Federal law restricts this drug to use by or on the order 
of a licensed veterinarian.
    (2) Horses--(i) Amount. Administer 1.8 mg (1 mL) by intramuscular 
injection in the neck.
    (ii) Indications for use. For inducing ovulation within 48 hours in 
cyclic estrous mares with an ovarian follicle between 30 and 40 mL in 
diameter.
    (iii) Limitations. Do not use in horses intended for human 
consumption. Federal law restricts this drug to use by or on the order 
of a licensed veterinarian.

[75 FR 81456, Dec. 28, 2010, as amended at 79 FR 18158, Apr. 1, 2014]



Sec. 522.535  Desoxycorticosterone.

    (a) Specifications. Each milliliter of suspension contains 25 
milligrams (mg) of desoxycorticosterone pivalate.
    (b) Sponsors. See sponsor numbers in Sec. 510.600(c) of this 
chapter.
    (1) No. 043264 for use as in paragraphs (c)(1)(i), (c)(2)(i), and 
(c)(3) of this section.
    (2) No. 058198 for use as in paragraphs (c)(1)(ii), (c)(2)(ii), and 
(c)(3) of this section.
    (c) Conditions of use--(1) Amount. (i) Administer an initial dose of 
2.2 mg/kilogram (1 mg/lb) of body weight by subcutaneous injection. 
Subsequent dosages should be individualized according to label 
instructions based on patient response to therapy.
    (ii) Dosage requirements are variable and must be individualized on 
the basis of the response of the patient to therapy. Initial dose of 1 
milligram per pound (0.45 kilogram) of body weight every 25 days, 
intramuscularly. Usual dose is 0.75 to 1.0 milligram per pound of body 
weight every 21 to 30 days.
    (2) Indications for use--(i) For use as replacement therapy for 
mineralocorticoid deficiency in dogs with primary hypoadrenocorticism 
(Addison's Disease).
    (ii) For use as replacement therapy for the mineralocorticoid 
deficit in dogs with primary adrenocortical insufficiency.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[81 FR 22524, Apr. 18, 2016]



Sec. 522.536  Detomidine.

    (a) Specification. Each milliliter of solution contains 10 
milligrams of detomidine hydrochloride.
    (b) Sponsor. See Nos. 015914 and 052483 in Sec. 510.600(c) of this 
chapter.

[[Page 284]]

    (c) Conditions of use in horses--(1) Amount. For sedation, 
analgesia, or sedation and analgesia: 20 or 40 micrograms per kilogram 
(0.2 or 0.4 milliliter per 100 kilogram or 220 pounds) by body weight, 
depending on depth and duration required. For sedation, administer by 
intraveneous (IV) or intramuscular (IM) injection; for analgesia, 
administer by IV injection; for both sedation and analgesia, administer 
by IV injection.
    (2) Indication for use. As a sedative and analgesic to facilitate 
minor surgical and diagnostic procedures in mature horses and yearlings.
    (3) Limitations. Do not use in horses intended for human 
consumption. Federal law restricts this drug to use by or on the order 
of a licensed veterinarian.

[79 FR 16186, Mar. 25, 2014, as amended at 86 FR 13184, Mar. 8, 2021]



Sec. 522.540  Dexamethasone solution.

    (a)(1) Specifications. Each milliliter of solution contains 2 
milligrams (mg) dexamethasone.
    (2) Sponsors. See sponsors in Sec. 510.600(c) of this chapter:
    (i) Nos. 000061, 016592, and 061133 for use as in paragraph (a)(3) 
of this section.
    (ii) Sponsors. See Nos. 054925 and 058005 for use as in paragraphs 
(a)(3)(i)(C), (a)(3)(i)(D), (a)(3)(ii)(A), and (a)(3)(iii) of this 
section.
    (3) Conditions of use--(i) Amount. The drug is administered 
intravenously or intramuscularly and dosage may be repeated if 
necessary, as follows:
    (A) Dogs. 0.25 to 1 mg.
    (B) Cats. 0.125 to 0.5 mg.
    (C) Horses. 2.5 to 5 mg.
    (D) Cattle. 5 to 20 mg, depending on the severity of the condition.
    (ii) Indications for use. The drug is indicated:
    (A) For the treatment of primary bovine ketosis and as an anti-
inflammatory agent in cattle and horses;
    (B) As an anti-inflammatory agent in dogs and cats.
    (iii) Limitations. Do not use in horses intended for human 
consumption. Federal law restricts this drug to use by or on the order 
of a licensed veterinarian.
    (b)(1) Specifications. Each milliliter of solution contains 2.0 mg 
of dexamethasone or 4.0 mg of dexamethasone sodium phosphate (equivalent 
to 3.0 mg dexamethasone).
    (2) Sponsor. See No. 061133 in Sec. 510.600(c) of this chapter.
    (3) Conditions of use--(i) Amount. Administer 0.25 to 1 mg by 
intravenous injection, repeated for 3 to 5 days or until a response is 
noted.
    (ii) Indications for use. For use in dogs for the treatment of 
inflammatory conditions, as supportive therapy in canine posterior 
paresis, as supportive therapy before or after surgery to enhance 
recovery of poor surgical risks, and as supportive therapy in 
nonspecific dermatosis.
    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.
    (c)(1) Specifications. Each milliliter of solution contains 2.0 mg 
of dexamethasone or 4.0 mg of dexamethasone sodium phosphate (equivalent 
to 3.0 mg of dexamethasone).
    (2) Sponsor. See No. 061133 in Sec. 510.600(c) of this chapter.
    (3) Conditions of use--(i) Amount. Administer 2.5 to 5.0 mg by 
intravenous injection.
    (ii) Indications for use. For use in horses as a rapid adrenal 
glucocorticoid and/or anti-inflammatory agent.
    (iii) Limitations. Do not use in horses intended for human 
consumption. Federal law restricts this drug to use by or on the order 
of a licensed veterinarian.
    (d)(1) Specifications. Each milliliter of solution contains 2.0 mg 
of dexamethasone or 4.0 mg of dexamethasone sodium phosphate (equivalent 
to 3.0 mg of dexamethasone).
    (2) Sponsors. See the following numbers in Sec. 510.600(c) of this 
chapter:
    (i) Nos. 016592 and 051031 for intravenous or intramuscular use of 
2.0 milligrams dexamethasone injection.
    (ii) No. 054771 for intravenous use of 2.0 milligrams dexamethasone 
injection.
    (3) Conditions of use--(i) Amount. Administer by intravenous or 
intramuscular injection as follows:
    (A) Dogs: 0.25 to 1 mg.
    (B) Cats: 0.125 to 0.5 mg.
    (C) Horses: 2.5 to 5 mg.
    (ii) Indications for use. For use in dogs, cats, and horses as an 
anti-inflammatory agent.

[[Page 285]]

    (iii) Limitations. Do not use in horses intended for human 
consumption. Federal law restricts this drug to use by or on the order 
of a licensed veterinarian.
    (e)(1) Specifications. Each milliliter of solution contains 4.0 mg 
of dexamethasone sodium phosphate (equivalent to 3.0 mg dexamethasone).
    (2) Sponsor. See No. 069043 in Sec. 510.600(c) of this chapter.
    (3) Conditions of use--(i) Amount. Administer by intravenous 
injection as follows:
    (A) Dogs: 0.25 to 1 mg; may be repeated for 3 to 5 days.
    (B) Horses: 2.5 to 5 mg.
    (ii) Indications for use. For use in dogs and horses for 
glucocorticoid and anti-inflammatory effect.
    (iii) Limitations. Do not use in horses intended for human 
consumption. Federal law restricts this drug to use by or on the order 
of a licensed veterinarian.

[41 FR 28265, July 9, 1976]

    Editorial Note: For Federal Register citations affecting Sec. 
522.540, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and at www.govinfo.gov.



Sec. 522.542  Dexamethasone suspension.

    (a) Specifications. Each milliliter of suspension contains 1 
milligram (mg) of dexamethasone-21-isonicotinate.
    (b) Sponsor. No. 000010 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use--(1) Amount. Administer by intramuscular 
injection as follows: Dogs: 0.25 to 1 mg; cats: 0.125 to 0.5 mg; horses: 
5 to 20 mg. Dosage may be repeated.
    (2) Indications for use. For the treatment of various inflammatory 
conditions associated with the musculoskeletal system in dogs, cats, and 
horses.
    (3) Limitations. Do not use in horses intended for human 
consumption. Federal law restricts this drug to use by or on the order 
of a licensed veterinarian.

[79 FR 16186, Mar. 25, 2014]



Sec. 522.558  Dexmedetomidine.

    (a) Specifications. Each milliliter of solution contains:
    (1) 0.1 milligrams (mg) dexmedetomidine hydrochloride; or
    (2) 0.5 mg dexmedetomidine hydrochloride.
    (b) Sponsors. See sponsors in in Sec. 510.600(c) of this chapter 
for use as in paragraph (c) of this section:
    (1) No. 026637 for use of product described in paragraph (a)(2) of 
this section;
    (2) No. 052483 for use of products described in paragraph (a) of 
this section.
    (c) Conditions of use--(1) Dogs--(i) Indications for use and amount. 
(A) For use as a sedative and analgesic to facilitate clinical 
examinations, clinical procedures, minor surgical procedures, and minor 
dental procedures, administer 375 micrograms ([micro]g) per square meter 
(/m\2\) of body surface area by intravenous injection or 500 [micro]g/
m\2\ of body surface area by intramuscular injection.
    (B) For use as a preanesthetic to general anesthesia, administer 125 
[micro]g/m\2\ of body surface area or 375 [micro]g/m\2\ of body surface 
area by intramuscular injection.
    (ii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.
    (2) Cats--(i) Amount. 40 [micro]g/killogram by intramuscular 
injection.
    (ii) Indications for use. For use as a sedative and analgesic to 
facilitate clinical examinations, clinical procedures, minor surgical 
procedures, and minor dental procedures; and as a preanesthetic to 
general anesthesia.
    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

[72 FR 263, Jan. 4, 2007, as amended at 72 FR 19797, Apr. 20, 2007; 72 
FR 51365, Sept. 7, 2007; 75 FR 60308, Sept. 30, 2010; 78 FR 25183, Apr. 
30, 2013; 78 FR 33699, June 5, 2013; 80 FR 13229, Mar. 13, 2015]



Sec. 522.563  Diatrizoate.

    (a) Specifications. Each milliliter of solution contains 34.3 
percent diatrizoate meglumine and 35 percent diatrizoate sodium, or 66 
percent diatrizoate meglumine and 10 percent diatrizoate sodium.
    (b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in dogs and cats--(1) Amount. For excretion 
urography, administer 0.5 to 1.0 milliliter (mL) per pound of body 
weight to a maximum of

[[Page 286]]

30 mL intravenously. For cystography, remove urine, administer 5 to 25 
mL directly into the bladder via catheter. For urethrography, administer 
1.0 to 5 mL via catheter into the urethra to provide desired contrasts 
delineation. For angiocardiography (including aortography) rapidly 
inject 5 to 10 mL directly into the heart via catheter or 
intraventricular puncture. For cerebral angiography, rapid injection of 
3 to 10 mL via carotid artery. For peripheral arteriography and/or 
venography and selective coronary arteriography, rapidly inject 3 to 10 
mL intravascularly into the vascular bed to be delineated. For 
lymphography, slowly inject 1.0 to 10 mL directly into the lymph vessel 
to be delineated. For arthrography, slowly inject 1.0 to 5 mL directly 
into the joint to be delineated. For discography, slowly inject 0.5 to 
1.0 mL directly into the disc to be delineated. For sialography, slowly 
inject 0.5 to 1.0 mL into the duct to be delineated. For delineation of 
fistulous tracts, slowly inject quantity necessary to fill the tract. 
For delineation of peritoneal hernias, inject 0.5 to 1.0 mL per pound of 
body weight directly into the peritoneal cavity.
    (2) Indications for use. For visualization in excretion urography, 
including renal angiography, uretography, cystography, and 
urethrography; aortography; angiocardiography, peripheral arteriography, 
and venography; selective coronary arteriography; cerebral angiography; 
lymphography; arthrography; discography; and sialography; and as an aid 
in delineating peritoneal hernias and fistulous tracts.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[79 FR 16186, Mar. 25, 2014]



Sec. 522.650  Dihydrostreptomycin sulfate injection.

    (a) Specifications. Each milliliter contains dihydrostreptomycin 
sulfate equivalent to 500 milligrams of dihydrostreptomycin.
    (b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
    (c) Related tolerance. See Sec. 556.200 of this chapter.
    (d) Conditions of use--(1) Amount. Administer 5 milligrams per pound 
of body weight by deep intramuscular injection every 12 hours, for 3 to 
5 days or until the urine is free of leptospira for at least 72 hours as 
measured by darkfield microscopic examination.
    (2) Indications for use. Treatment of leptospirosis in dogs and 
horses due to Leptospira canicola, L. icterohemorrhagiae, and L. pomona; 
in cattle due to L. pomona; and in swine due to L. pomona; and L. 
grippotyphosa.
    (3) Limitations. Discontinue use 30 days before slaughter for food. 
Not for use in animals producing milk because use of the drug will 
contaminate the milk. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

[57 FR 37331, Aug. 18, 1992; 57 FR 42623, Sept. 15, 1992; 79 FR 16187, 
Mar. 25, 2014; 85 FR 18119, Apr. 1, 2020]



Sec. 522.690  Dinoprost.

    (a) Specifications. Each milliliter (mL) of solution contains 
dinoprost tromethamine equivalent to 5 milligrams (mg) or 12.5 mg 
dinoprost.
    (b) Sponsors. See sponsors in Sec. 510.600(c) of this chapter.
    (1) No. 054771 for use of the 12.5 mg/mL product as in paragraph 
(d)(1) of this section.
    (2) No. 054771 for use of the 5 mg/mL product as in paragraphs 
(d)(1), (2), and (3) of this section.
    (3) No. 061133 for use of the 5 mg/mL product as in paragraphs 
(d)(2), (3), and (4) of this section.
    (c) Special considerations. Federal law restricts this drug to use 
by or on the order of a licensed veterinarian.
    (d) Conditions of use--(1) Cattle. Administer product described in 
paragraph (b)(1) of this section as follows:
    (i) Amount. 25 mg as a single intramuscular or subcutaneous 
injection.
    (ii) Indications for use. As a luteolytic agent; effective only in 
those cattle having a corpus luteum, i.e., those which ovulated at least 
5 days prior to treatment.
    (A) For estrus synchronization in beef cows, beef heifers and 
replacement dairy heifers.

[[Page 287]]

    (B) For unobserved (silent) estrus in lactating dairy cows with a 
corpus luteum.
    (C) For treatment of pyometra (chronic endometritis) in cattle.
    (D) For abortion in beef cows, beef heifers and replacement dairy 
heifers.
    (E) For use with gonadorelin injection as in Sec. 522.1077 of this 
chapter to synchronize estrous cycles to allow fixed-time artificial 
insemination (FTAI) in lactating dairy cows.
    (F) For use with progesterone intravaginal inserts as in Sec. 
529.1940 of this chapter for synchronization of estrus in lactating 
dairy cows.
    (G) For use with progesterone intravaginal inserts as in Sec. 
529.1940 of this chapter for synchronization of estrus in suckled beef 
cows and replacement beef and dairy heifers, advancement of first 
postpartum estrus in suckled beef cows, and advancement of first 
pubertal estrus in beef heifers.
    (2) Horses--(i) Amount. 1 mg per 100 pounds of body weight as a 
single intramuscular injection.
    (ii) Indications for use. For its luteolytic effect to control 
timing of estrus in estrus cycling mares and in clinically anestrous 
mares that have a corpus luteum.
    (iii) Limitations. Do not use in horses intended for human 
consumption.
    (3) Swine--(i) Amount. 10 mg as a single intramuscular injection.
    (ii) Indications for use. For parturition induction in swine when 
injected within 3 days of normal predicted farrowing.
    (4) Cattle. Administer product described in paragraph (b)(2) of this 
section as follows:
    (i) Beef cattle and nonlactating dairy heifers--(A) Amount. 25 mg as 
an intramuscular injection either once or twice at a 10- to 12-day 
interval.
    (B) Indications. For its luteolytic effect to control timing of 
estrus and ovulation in estrous cycling cattle that have a corpus 
luteum.
    (ii) Beef cattle and nonlactating dairy heifers--(A) Amount. 25 mg 
as a single intramuscular injection.
    (B) Indications. For treatment of pyometra (chronic endometritis).
    (iii) Nonlactating cattle--(A) Amount. 25 mg as a single 
intramuscular injection during the first 100 days of gestation.
    (B) Indications. For its abortifacient effect in nonlactating 
cattle.
    (iv) Lactating dairy cattle--(A) Amount. 25 mg as a single 
intramuscular injection.
    (B) Indications. For treatment of unobserved (silent) estrus in 
lactating dairy cattle that have a corpus luteum.
    (v) Dinoprost injection as provided by No. 054771 in Sec. 
510.600(c) of this chapter may also be used concurrently with 
gonadorelin hydrochloride injection as in Sec. 522.1077 and with 
progesterone intravaginal inserts as in Sec. 529.1940 of this chapter.

[67 FR 41824, June 20, 2002, as amended at 79 FR 16187, Mar. 25, 2014; 
79 FR 44278, July 31, 2014; 79 FR 64116, Oct. 28, 2014; 80 FR 61296, 
Oct. 13, 2015; 80 FR 76386, Dec. 9, 2015; 81 FR 36789, June 8, 2016; 84 
FR 8973, Mar. 13, 2019]



Sec. 522.723  Diprenorphine.

    (a) Specifications. Each milliliter of solution contains 2 
milligrams of diprenorphine hydrochloride.
    (b) Sponsors. See No. 053923 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use--(1) Amount. It is administered 
intramuscularly or intravenously at a suitable dosage level depending 
upon the species.
    (2) Indications for use. The drug is used for reversing the effects 
of etorphine hydrochloride injection, veterinary, the use of which is 
provided for in Sec. 522.883, in wild and exotic animals.
    (3) Limitations. For use in wild or exotic animals only. Do not use 
in domestic food-producing animals. Do not use 30 days before, or 
during, the hunting season in free-ranging wild animals that might be 
used for food. Federal law restricts this drug to use by or on the order 
of a licensed veterinarian. Distribution is restricted to veterinarians 
engaged in zoo and exotic animal practice, wildlife management programs, 
and researchers.

[79 FR 16187, Mar. 25, 2014]



Sec. 522.728  Dipyrone.

    (a) Specifications. Each milliliter of solution contains 500 
milligrams (mg) dipyrone.
    (b) Sponsor. See No. 086078 in Sec. 510.600(c) of this chapter.

[[Page 288]]

    (c) Conditions of use in horses--(1) Amount. Administer 30 mg per 
kilogram of body weight (13.6 mg per pound) by intravenous injection, 
once or twice daily at a 12-hour interval for up to 3 days.
    (2) Indications for use. For control of pyrexia in horses.
    (3) Limitations. Do not use in horses intended for human 
consumption. Do not use in any food-producing animals, including 
lactating dairy animals. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

[85 FR 18119, Apr. 1, 2020]



Sec. 522.770  Doramectin.

    (a) Specifications. Each milliliter of solution contains 10 
milligrams of doramectin.
    (b) Sponsor. See No. 054771 in Sec. 510.600 (c) of this chapter.
    (c) Related tolerances. See Sec. 556.222 of this chapter.
    (d) Conditions of use--(1) Cattle--(i) Amount. 200 micrograms per 
kilogram (10 milligrams per 110 pounds).
    (ii) Indications for use. For treatment and control of 
gastrointestinal roundworms, lungworms, eyeworms, grubs, sucking lice, 
and mange mites. To control infections and to protect from reinfection 
with Cooperia oncophora and Haemonchus placei for 14 days, Ostertagia 
ostertagi for 21 days, and C. punctata, Oesophagostomum radiatum, and 
Dictyocaulus viviparus for 28 days after treatment.
    (iii) Limitations. Administer as a single subcutaneous or 
intramuscular injection. Do not slaughter cattle within 35 days of 
treatment. Not for use in female dairy cattle 20 months of age or older. 
Do not use in calves to be processed for veal.
    (2) Swine--(i) Amount. 300 micrograms per kilogram (10 milligrams 
per 75 pounds).
    (ii) Indications for use. For treatment and control of 
gastrointestinal roundworms, lungworms, kidney worms, sucking lice, and 
mange mites.
    (iii) Limitations. Administer as a single intramuscular injection. 
Do not slaughter swine within 24 days of treatment. Consult your 
veterinarian for assistance in the diagnosis, treatment, and control of 
parasitism.

[61 FR 53321, Oct. 11, 1996, as amended at 62 FR 44410, Aug. 21, 1997; 
62 FR 62242, Nov. 21, 1997; 63 FR 68183, Dec. 10, 1998; 64 FR 13509, 
Mar. 19, 1999; 79 FR 16187, Mar. 25, 2014; 84 FR 32992, July 11, 2019]



Sec. 522.775  Doxapram.

    (a) Specifications. Each milliliter of solution contains 20 
milligrams (mg) doxapram hydrochloride.
    (b) Sponsor. See No. 000010 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use--(1) Amount. For intravenous use in dogs and 
cats at a dose of 2\1/2\ to 5 mg per pound (/lb) body weight in 
barbiturate anesthesia, 0.5 mg/lb in inhalation anesthesia; for 
intravenous use in horses at 0.25 mg/lb body weight in barbiturate 
anesthesia, 0.2 mg/lb in inhalation anesthesia, 0.25 mg/lb with chloral 
hydrate with or without magnesium sulfate; for subcutaneous, sublingual, 
or umbilical vein administration in neonate puppies at a dose rate of 1 
to 5 mg; for subcutaneous or sublingual use in neonate kittens at 1 to 2 
mg. Dosage may be repeated in 15 to 20 minutes if necessary.
    (2) Indications for use. Administer to dogs, cats, and horses to 
stimulate respiration during and after general anesthesia; or to speed 
awakening and return of reflexes after anesthesia. Administer to neonate 
dogs and cats to initiate respiration following dystocia or caesarean 
section; or to stimulate respiration following dystocia or caesarean 
section.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[72 FR 261, Jan. 4, 2007, as amended at 75 FR 10167, Mar. 5, 2010; 77 FR 
60302, Oct. 3, 2012]



Sec. 522.784  Doxylamine.

    (a) Specifications. Each milliliter contains 11.36 milligrams (mg) 
of doxylamine succinate.
    (b) Sponsor. See No. 000061 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use--(1) Amount--(i) Horses: Administer 25 mg per 
hundred pounds of body weight by intramuscular, subcutaneous, or slow 
intravenous injection.
    (ii) Dogs and cats: Administer 0.5 to 1 mg per pound of body weight 
by

[[Page 289]]

intramuscular or subcutaneous injection. Doses may be repeated at 8 to 
12 hours, if necessary, to produce desired effect.
    (2) Indications for use. For use in conditions in which 
antihistaminic therapy may be expected to alleviate some signs of 
disease in horses, dogs, and cats.
    (3) Limitations. Do not use in horses intended for human 
consumption. Federal law restricts this drug to use by or on the order 
of a licensed veterinarian.

[79 FR 16187, Mar. 25, 2014]



Sec. 522.800  Droperidol and fentanyl.

    (a) Specifications. Each milliliter of solution contains 20 
milligrams (mg) of droperidol and 0.4 mg of fentanyl citrate.
    (b) Sponsor. See No. 000061 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use--(1) Amount. (i) For analgesia and 
tranquilization, administer as follows:
    (A) 1 milliliter (mL) per 15 to 20 pounds (lbs) of body weight by 
intramuscular injection in conjunction with atropine sulfate 
administered at the rate of 0.02 mg per pound of body weight; or
    (B) 1 mL per 25 to 60 lbs of body weight by intravenous injection in 
conjunction with atropine sulfate administered at the rate of 0.02 mg 
per pound of body weight.
    (ii) For general anesthesia, administer as follows:
    (A) Administer 1 mL per 40 lbs of body weight by intramuscular 
injection in conjunction with atropine sulfate administered at the rate 
of 0.02 mg per pound of body weight and followed in 10 minutes by an 
intravenous administration of sodium pentobarbital at the rate of 3 mg 
per pound of body weight; or
    (B) Administer 1 mL per 25 to 60 lbs of body weight by intravenous 
injection in conjunction with atropine sulfate administered at the rate 
of 0.02 mg per pound of body weight and followed within 15 seconds by an 
intravenous administration of sodium pentobarbital at the rate of 3 mg 
per pound of body weight.
    (2) Indications for use. As an analgesic and tranquilizer and for 
general anesthesia.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[79 FR 16187, Mar. 25, 2014]



Sec. 522.810  Embutramide, chloroquine, and lidocaine solution.

    (a) Specifications. Each milliliter (mL) of solution contains 135 
milligrams (mg) embutramide; 45 mg chloroquine phosphate, U.S.P.; and 
1.9 mg lidocaine, U.S.P.
    (b) Sponsor. See No. 069043 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in dogs--(1) Amount. One mL per 5 pounds of 
body weight.
    (2) Indications for use. For euthanasia.
    (3) Limitations. Not for use in animals intended for food. Federal 
law restricts this drug to use by or on the order of a licensed 
veterinarian.

[70 FR 36337, June 23, 2005, as amended at 78 FR 17597, Mar. 22, 2013; 
81 FR 17608, Mar. 30, 2016]



Sec. 522.812  Enrofloxacin.

    (a) Specifications. Each milliliter (mL) of solution contains:
    (1) 22.7 milligrams (mg) enrofloxacin or
    (2) 100 mg enrofloxacin.
    (b) Sponsors. See sponsor numbers in Sec. 510.600(c) of this 
chapter:
    (1) Nos. 017033, 055529, and 058198 for use of product described in 
paragraph (a)(1) of this section as in paragraph (e)(1) of this section; 
and
    (2) Nos. 055529, 058198, and 061133 for use of product described in 
paragraph (a)(2) of this section as in paragraphs (e)(2) and (3) of this 
section.
    (c) Related tolerance. See Sec. 556.226 of this chapter.
    (d) Special considerations. Federal law restricts this drug to use 
by or on the order of a licensed veterinarian. Federal law prohibits the 
extra-label use of this drug in food-producing animals.
    (e) Conditions of use--(1) Dogs. Use the product described in 
paragraph (a)(1) of this section as follows:
    (i) Amount. 2.5 mg per kilogram (/kg) of body weight (1.13 mg per 
pound) as a single, intramuscular, initial dose followed by use of 
tablets twice daily for 2 to 3 days beyond cessation of clinical signs 
to a maximum of 10 days.

[[Page 290]]

    (ii) Indications for use. For the management of diseases associated 
with bacteria susceptible to enrofloxacin.
    (2) Cattle. Use the product described in paragraph (a)(2) of this 
section as follows:
    (i) Amount--(A) Single-dose therapy: For treatment of bovine 
respiratory disease (BRD), administer 7.5 to 12.5 mg/kg of body weight 
(3.4 to 5.7 mL per 100 pounds (/100 lb)) once by subcutaneous injection. 
For control of BRD, administer 7.5 mg/kg of body weight (3.4 mL/100 lb) 
once by subcutaneous injection.
    (B) Multiple-day therapy: For treatment of BRD, administer 2.5 to 
5.0 mg/kg of body weight (1.1 to 2.3 mL/100 lb) by subcutaneous 
injection. Treatment should be repeated at 24-hour intervals for 3 days. 
Additional treatments may be given on days 4 and 5 to animals that have 
shown clinical improvement but not total recovery.
    (ii) Indications for use--(A) Single-dose therapy: For the treatment 
of BRD associated with Mannheimia haemolytica, Pasteurella multocida, 
Histophilus somni, and Mycoplasma bovis in beef and non-lactating dairy 
cattle; for the control of BRD in beef and non-lactating dairy cattle at 
high risk of developing BRD associated with M. haemolytica, P. 
multocida, H. somni and M. bovis.
    (B) Multiple-day therapy: For the treatment of bovine respiratory 
disease (BRD) associated with Mannheimia haemolytica, Pasteurella 
multocida, and Histophilus somni in beef and non-lactating dairy cattle.
    (iii) Limitations. Animals intended for human consumption must not 
be slaughtered within 28 days from the last treatment. This product is 
not approved for female dairy cattle 20 months of age or older, 
including dry dairy cows. Use in these cattle may cause drug residues in 
milk and/or in calves born to these cows. A withdrawal period has not 
been established for this product in preruminating calves. Do not use in 
calves to be processed for veal.
    (3) Swine. Use the product described in paragraph (a)(2) of this 
section as follows:
    (i) Amounts and indications for use. (A) Administer 7.5 mg/kg of 
body weight once, by intramuscular or subcutaneous injection behind the 
ear, for the treatment and control of swine respiratory disease (SRD) 
associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, 
Haemophilus parasuis, Streptococcus suis, Bordetella bronchiseptica, and 
Mycoplasma hyopneumoniae.
    (B) Administer 7.5 mg/kg of body weight once, by intramuscular or 
subcutaneous injection behind the ear, for the control of colibacillosis 
in groups or pens of weaned pigs where colibacillosis associated with 
Escherichia coli has been diagnosed.
    (ii) Limitations. Animals intended for human consumption must not be 
slaughtered within 5 days of receiving a single-injection dose.

[72 FR 10597, Mar. 9, 2007, as amended at 73 FR 17890, Apr. 2, 2008; 73 
FR 21819, Apr. 23, 2008; 76 FR 22611, Apr. 22, 2011; 77 FR 55415, Sept. 
10, 2012; 77 FR 76863, Dec. 31, 2012; 78 FR 19987, Apr. 3, 2013; 79 FR 
37620, July 2, 2014; 80 FR 13229, Mar. 13, 2015; 80 FR 18776, Apr. 8, 
2015; 80 FR 61296, Oct. 13, 2015; 84 FR 8973, Mar. 13, 2019; 84 FR 
53311, Oct. 7, 2019; 86 FR 14819, Mar. 19, 2021]



Sec. 522.814  Eprinomectin.

    (a) Specifications. Each milliliter of solution contains 50 
milligrams (mg) eprinomectin.
    (b) Sponsor. See No. 000010 in Sec. 510.600(c) of this chapter.
    (c) Related tolerances. See Sec. Sec. 500.1410 and 556.227 of this 
chapter.
    (d) Conditions of use in cattle on pasture--(1) Amount. Administer 1 
mg/kilogram of body weight by subcutaneous injection.
    (2) Indications for use. For the treatment and control of the 
following internal and external parasites: Gastrointestinal roundworms 
(adults and fourth-stage larvae) Bunostomum phlebotomum, Cooperia 
oncophora, C. punctata, C. surnabada, Trichostrongylus axei, Ostertagia 
ostertagi (including inhibited stage); (adults) Haemonchus placei, 
Oesophagostomum radiatum, O. lyrata, T. colubriformis; lungworms 
(adults) Dictyocaulus viviparus; cattle grubs Hypoderma bovis; mites 
Sarcoptes scabiei var. bovis. Prevents reinfection with C. oncophora, C. 
punctata, and T. axei for 100 days following treatment; H. placei, O. 
radiatum, O. lyrata, and O. ostertagi for 120 days following treatment; 
and B. phlebotomum and D.

[[Page 291]]

viviparus for 150 days following treatment.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian. Animals intended for human consumption 
must not be slaughtered within 48 days of the last treatment. This drug 
product is not approved for use in female dairy cattle 20 months of age 
or older, including dry dairy cows. Use in these cattle may cause drug 
residues in milk and/or in calves born to these cows. A withdrawal 
period has not been established for pre-ruminating calves. Do not use in 
calves to be processed for veal.

[76 FR 72618, Nov. 25, 2011, as amended at 79 FR 37620, July 2, 2014; 84 
FR 39184, Aug. 9, 2019]



Sec. 522.820  Erythromycin.

    (a) Specifications--(1) Each milliliter (mL) of solution contains 
100 milligrams (mg) erythromycin base.
    (2) Each mL of solution contains 200 mg erythromycin base.
    (b) Sponsor. See No. 061133 in Sec. 510.600(c) of this chapter.
    (c) Related tolerances. See Sec. 556.230 of this chapter.
    (d) Conditions of use--(1) Dog. Administer product described in 
paragraph (a)(1) of this section as follows:
    (i) Amount. 3 to 5 mg per pound (/lb) body weight, intramuscularly, 
two to three times daily, for up to 5 days.
    (ii) Indications for use. For the treatment of bacterial pneumonia, 
upper respiratory infections (tonsillitis, bronchitis, tracheitis, 
pharyngitis, pleurisy), endometritis and metritis, and bacterial wound 
infections caused by Staphylococcus spp., Streptococcus spp., and 
Corynebacterium spp., sensitive to erythromycin.
    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.
    (2) Cats. Administer product described in paragraph (a)(1) of this 
section as follows:
    (i) Amount. 3 to 5 mg/lb body weight, intramuscularly, two to three 
times daily, for up to 5 days.
    (ii) Indications for use. For the treatment of bacterial pneumonia, 
upper respiratory infections (rhinitis, bronchitis), secondary 
infections associated with panleukopenia, and bacterial wound infections 
caused by Staphylococcus spp. and Streptococcus spp., susceptible to 
erythromycin.
    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.
    (3) Cattle. Administer products described in paragraph (a) of this 
section as follows:
    (i) Amount. 4 mg/lb body weight by deep intramuscular injection once 
daily for up to 5 days.
    (ii) Indications for use. For the treatment of bovine respiratory 
disease (shipping fever complex and bacterial pneumonia) associated with 
Pasteurella multocida susceptible to erythromycin.
    (iii) Limitations. Do not use in female dairy cattle over 20 months 
of age. Do not slaughter treated animals within 6 days of last 
treatment. A withdrawal period has not been established for this product 
in pre-ruminating calves. Do not use in calves to be processed for veal. 
To avoid excess trim, do not slaughter within 21 days of last injection.

[72 FR 69142, Dec. 7, 2007, as amended at 79 FR 16187, Mar. 25, 2014; 84 
FR 8973, Mar. 13, 2019]



Sec. 522.840  Estradiol.

    (a) Specifications. Each silicone rubber implant contains 25.7 or 
43.9 milligrams (mg) estradiol and is coated with not less than 0.5 mg 
oxytetracycline powder.
    (b) Sponsor. See No. 058198 in Sec. 510.600(c) of this chapter.
    (c) Related tolerances. See Sec. 556.240 of this chapter.
    (d) Conditions of use. For implantation in steers and heifers as 
follows:
    (1) Amount. Insert one 25.7-mg implant every 200 days; insert one 
43.9-mg implant every 400 days.
    (2) Indications for use. For increased rate of weight gain in 
suckling and pastured growing steers; for improved feed efficiency and 
increased rate of weight gain in confined steers and heifers. No 
additional effectiveness may be expected from reimplanting in less than 
200 days for the 25.7-mg implant or 400 days for the 43.9-mg implant.
    (3) Limitations. For subcutaneous ear implantation in steers and 
heifers only. Safety and effectiveness have not been

[[Page 292]]

established in veal calves. A withdrawal period has not been established 
for this product in preruminating calves. Do not use in calves to be 
processed for veal.

[69 FR 67818, Nov. 22, 2004, as amended at 77 FR 31723, May 30, 2012; 81 
FR 48702, July 26, 2016]



Sec. 522.842  Estradiol benzoate and testosterone propionate.

    (a) Sponsors. See sponsors in Sec. 510.600(c) of this chapter for 
use as in paragraph (c) of this section.
    (1) No. 054771 for use as in paragraph (c)(1)(i), (c)(2), and (c)(3) 
of this section.
    (2) No. 058198 for use as in paragraph (c) of this section.
    (b) Related tolerances. See Sec. Sec. 556.240 and 556.710 of this 
chapter.
    (c) Conditions of use. For implantation in heifers as follows:
    (1) Amount. (i) 20 milligrams (mg) estradiol benzoate and 200 mg 
testosterone propionate (one implant consisting of 8 pellets, each 
pellet containing 2.5 mg estradiol benzoate and 25 mg testosterone 
propionate) per implant dose.
    (ii) 20 mg estradiol benzoate and 200 mg testosterone propionate 
(one implant consisting of 9 pellets, each of 8 pellets containing 2.5 
mg estradiol benzoate and 25 mg testosterone propionate, and 1 pellet 
containing 29 mg tylosin tartrate) per implant dose.
    (2) Indications for use. For increased rate of weight gain and 
improved feed efficiency.
    (3) Limitations. For heifers weighing 400 pounds or more; for 
subcutaneous ear implantation, one dose per animal; not for use in dairy 
or beef replacement heifers. Safety and effectiveness have not been 
established in veal calves. A withdrawal period has not been established 
for this product in preruminating calves. Do not use in calves to be 
processed for veal.

[69 FR 68252, Nov. 24, 2004, as amended at 77 FR 31723, May 30, 2012; 79 
FR 16187, Mar. 25, 2014; 81 FR 48702, July 26, 2016]



Sec. 522.850  Estradiol valerate and norgestomet in combination.

    (a) Specifications. The product is a two-component drug consisting 
of the following:
    (1) An implant containing 6.0 milligrams of norgestomet.
    (2) An injectable solution (sesame oil) containing 3.0 milligrams of 
norgestomet and 5.0 milligrams of estradiol valerate per 2 milliliters.
    (b) Sponsor. See 000010 in Sec. 510.600(c) of this chapter.
    (c) Related tolerances. See Sec. 556.240 of this chapter.
    (d) Conditions of use--(1) Amount. One implant and 2 milliliters of 
injection at time of implantation.
    (2) Indications for use. For synchronization of estrus/ovulation in 
cycling beef cattle and non-lactating dairy heifers.
    (3) Limitations. Insert implant subcutaneously in the ear only; then 
immediately inject solution intramuscularly only. Counting the day of 
implantation as day 1, remove the implant on day 10. Collect all 
implants as they are removed and burn them. While animals are restrained 
for artificial insemination, avoid other treatments such as 
vaccinations, dipping, pour-on grub and louse prevention, spraying, etc. 
When inseminating without estrus detection, the entire treated group 
should be started at 48 hours after the last implant has been removed 
and should be completed within 6 hours. Where estrus detection is 
preferred, insemination should be approximately 12 hours after first 
detection of estrus. Those that do not conceive can be re-bred when they 
return to estrus approximately 17 to 25 days after implant removal. Do 
not use in cows producing milk for human consumption.

[47 FR 55477, Dec. 10, 1982, as amended at 48 FR 49656, Oct. 27, 1983; 
51 FR 33592, Sept. 22, 1986; 54 FR 1165, Jan. 12, 1989; 84 FR 39184, 
Aug. 9, 2019; 84 FR 32992, July 11, 2019]



Sec. 522.863  Ethylisobutrazine.

    (a) Specifications. Each milliliter of solution contains 50 
milligrams (mg) of ethylisobutrazine hydrochloride.
    (b) Sponsor. See No. 000061 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in dogs--(1) Amount. Administer 2 to 5 mg per 
pound of body weight by intramuscular injection for profound 
tranquilization. Administer 1 to 2 mg per pound of body

[[Page 293]]

weight by intravenous injection to effect.
    (2) Indications for use. For use as a tranquilizer.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[79 FR 16187, Mar. 25, 2014]



Sec. 522.870  Etodolac.

    (a) Specifications. Each milliliter contains 100 milligrams (mg) 
etodolac.
    (b) Sponsor. See No. 000010 in Sec. 510.600 of this chapter.
    (c) Conditions of use in dogs--(1) Amount. Administer 4.5 to 6.8 mg/
pound (10 to 15 mg/kilogram) body weight as a single, dorsoscapular 
subcutaneous injection. If needed, the daily dose of etodolac tablets as 
in Sec. 520.870 of this chapter may be given 24 hours after the 
injection.
    (2) Indications for use. For the control of pain and inflammation 
associated with osteoarthritis.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[72 FR 51365, Sept. 7, 2007, as amended at 75 FR 10167, Mar. 5, 2010]



Sec. 522.883  Etorphine.

    (a) Specifications. Each milliliter of solution contains 1 milligram 
of etorphine hydrochloride.
    (b) Sponsor. See No. 053923 in Sec. 510.600(c) of this chapter.
    (c) Special considerations. Distribution is restricted to 
veterinarians engaged in zoo and exotic animal practice, wildlife 
management programs, and researchers.
    (d) Conditions of use--(1) Amount. Administered intramuscularly by 
hand syringe or syringe dart at a suitable dosage level depending upon 
the species.
    (2) Indications for use. For the immobilization of wild and exotic 
animals.
    (3) Limitations. Do not use in domestic food-producing animals. Do 
not use 30 days before, or during, the hunting season in free-ranging 
wild animals that might be used for food. Federal law restricts this 
drug to use by or on the order of a licensed veterinarian.

[79 FR 16188, Mar. 25, 2014]



Sec. 522.914  Fenprostalene.

    (a) Specifications. (1) Each milliliter of solution contains 0.5 
milligram (mg) fenprostalene.
    (2) Each milliliter of solution contains 0.25 mg fenprostalene.
    (b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter for 
use of product described in paragraph (a)(1) as in paragraph (e)(1) of 
this section; and for use of product described in paragraph (a)(2) as in 
paragraph (e)(2) of this section.
    (c) Related tolerances. See Sec. 556.277 of this chapter.
    (d) Special considerations. Labeling shall bear the following 
statements: Women of childbearing age, asthmatics, and persons with 
bronchial and other respiratory problems should exercise extreme caution 
when handling this product. It is readily absorbed through the skin and 
may cause abortion and/or bronchiospasms. Accidental spillage on the 
skin should be washed off immediately with soap and water.
    (e) Conditions of use--(1) Cattle--(i) Indications for use and 
amount. (A) For feedlot heifers to induce abortion when pregnant 150 
days or less, administer 1 mg (2 milliliter (mL)) subcutaneously.
    (B) For beef or nonlactating dairy cattle for estrus 
synchronization, administer a single or two 1-mg (2-mL) doses 
subcutaneously, 11 to 13 days apart.
    (ii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.
    (2) Swine--(i) Amount. Administer a single injection of 0.25 mg (1 
mL) subcutaneously.
    (ii) Indications for use. For the induction of parturition in sows 
and gilts pregnant at least 112 days.
    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

[79 FR 16188, Mar. 25, 2014]



Sec. 522.930  Firocoxib.

    (a) Specifications. Each milliliter of solution contains 20 
milligrams (mg) firocoxib.
    (b) Sponsors. See No. 000010 in Sec. 510.600(c) of this chapter.

[[Page 294]]

    (c) Conditions of use in horses--(1) Amount. Administer 0.04 mg/
pound (lb) (0.09 mg/kilogram (kg)) of body weight (BW) intravenously, 
once daily, for up to 5 days. If further treatment is needed, firocoxib 
oral paste can be administered at a dosage of 0.045 mg/lb (0.1 mg/kg) of 
BW for up to an additional 9 days of treatment.
    (2) Indications for use. For the control of pain and inflammation 
associated with osteoarthritis.
    (3) Limitations. Do not use in horses intended for human 
consumption. Federal law restricts this drug to use by or on the order 
of a licensed veterinarian.

[75 FR 59611, Sept. 28, 2010, as amended at 84 FR 39184, Aug. 9, 2019]



Sec. 522.955  Florfenicol.

    (a) Specifications. Each milliliter of solution contains:
    (1) 300 milligrams (mg) florfenicol in the inactive vehicles 2-
pyrrolidone and triacetin.
    (2) 300 mg florfenicol in the inactive vehicles n-methyl-2-
pyrrolidone, propylene glycol, and polyethylene glycol.
    (3) 300 mg florfenicol in the inactive vehicles 2-pyrrolidone and 
glycerol formal.
    (b) Sponsors. See sponsor numbers in Sec. 510.600(c) of this 
chapter:
    (1) No. 000061 for use of product described in paragraph (a)(1) as 
in paragraph (d)(1)(i); and
    (2) Nos. 000061 and 058198 for use of product described in paragraph 
(a)(2) of this section as in paragraph (d)(1)(ii) of this section.
    (3) No. 055529 for use of product described in paragraph (a)(3) as 
in paragraph (d)(1)(ii).
    (c) Related tolerances. See Sec. Sec. 500.1410 and 556.283 of this 
chapter.
    (d) Conditions of use--(1) Beef and non-lactating dairy cattle. (i) 
300 mg per milliliter (mL) florfenicol in the inactive vehicles 2-
pyrrolidone and triacetin:
    (A) Amount. 40 mg/kilogram (kg) body weight as a single subcutaneous 
injection.
    (B) Indications for use. For treatment of bovine respiratory disease 
(BRD) associated with Mannheimia haemolytica, Pasteurella multocida, 
Histophilus somni, and Mycoplasma bovis in beef and non-lactating dairy 
cattle.
    (C) Limitations. Animals intended for human consumption must not be 
slaughtered within 44 days of treatment. Do not use in female dairy 
cattle 20 months of age or older. Use of florfenicol in this class of 
cattle may cause milk residues. A withdrawal period has not been 
established in pre-ruminating calves. Do not use in calves to be 
processed for veal. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.
    (ii) 300 mg/mL florfenicol in the inactive vehicles n-methyl-2- 
pyrrolidone, propylene glycol, and polyethylene glycol, or in 2-
pyrrolidone and glycerol formal:
    (A)(1) Amount. 20 mg/kg of body weight as an intramuscular 
injection. A second dose should be administered 48 hours later. 
Alternatively, 40 mg/kg of body weight as a single subcutaneous 
injection may be used.
    (2) Indications for use. For treatment of BRD associated with 
Mannheimia (Pasteurella) haemolytica, P. multocida, and Haemophilus 
somnus. For treatment of bovine interdigital phlegmon (foot rot, acute 
interdigital necrobacillosis, infectious pododermatitis) associated with 
Fusobacterium necrophorum and Bacteroides melaninogenicus.
    (B)(1) Amount. 40 mg/kg of body weight as a single subcutaneous 
injection.
    (2) Indications for use. For control of respiratory disease in 
cattle at high risk of developing BRD associated with Mannheimia 
(Pasteurella) haemolytica, P. multocida, and Haemophilus somnus.
    (C) Limitations. Animals intended for human consumption must not be 
slaughtered within 28 days of the last intramuscular treatment. Animals 
intended for human consumption must not be slaughtered within 33 days of 
subcutaneous treatment. This product is not approved for use in female 
dairy cattle 20 months of age or older, including dry dairy cows. Use in 
these cattle may cause drug residues in milk and/or in calves born to 
these cows. A withdrawal period has not been established in pre-
ruminating calves. Do not use in calves to be processed for veal. 
Federal law restricts this drug to use by or on the order of a licensed 
veterinarian.

[[Page 295]]

    (2) [Reserved]

[73 FR 21041, Apr. 18, 2008, as amended at 74 FR 66574, Dec. 16, 2009; 
79 FR 18158, Apr. 1, 2014; 79 FR 53136, Sept. 8, 2014; 80 FR 61296, Oct. 
13, 2015; 80 FR 76386, Dec. 9, 2015; 86 FR 14819, Mar. 19, 2021]



Sec. 522.956  Florfenicol and flunixin.

    (a) Specifications. Each milliliter (mL) of solution contains 300 
milligrams (mg) florfenicol and 16.5 mg flunixin (27.37 mg flunixin 
meglumine).
    (b) Sponsor. See No. 000061 in Sec. 510.600(c) of this chapter for 
use as in paragraph (d) of this section.
    (c) Tolerances. See Sec. Sec. 556.283 and 556.286 of this chapter.
    (d) Conditions for use in cattle--(1) Amount. 40 mg florfenicol/kg 
body weight (BW) and 2.2 mg flunixin/kg BW (equivalent to 2 mL/15 kg BW 
or 6 mL/100 lbs) once, by subcutaneous injection.
    (2) Indications for use. For treatment of bovine respiratory disease 
(BRD) associated with Mannheimia haemolytica, Pasteurella multocida, 
Histophilus somni, and Mycoplasma bovis, and control of BRD-associated 
pyrexia in beef and non-lactating dairy cattle.
    (3) Limitations. Animals intended for human consumption must not be 
slaughtered within 38 days of treatment. This drug product is not 
approved for use in female dairy cattle 20 months of age or older, 
including dry dairy cows. Use in these cattle may cause drug residues in 
milk and/or in calves born to these cows. A withdrawal period has not 
been established in preruminating calves. Do not use in calves to be 
processed for veal. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[75 FR 1275, Jan. 11, 2010, as amended at 75 FR 54018, Sept. 3, 2010; 79 
FR 18158, Apr. 1, 2014]



Sec. 522.960  Flumethasone injectable dosage forms.



Sec. 522.960a  Flumethasone suspension.

    (a) Specifications. Each milliliter of suspension contains 2 
milligrams (mg) of flumethasone.
    (b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in horses--(1) Amount. Administer 6 to 10 mg 
by intra-articular injection. Dosage is limited to a single injection 
per week in any one synovial structure.
    (2) Indications for use. For use in the various disease states 
involving synovial structures (joints) of horses where excessive 
synovial fluid of inflammatory origin is present and where permanent 
structural changes do not exist. Such conditions include arthritis, 
carpitis, and osselets.
    (3) Limitations. Do not use in horses intended for human 
consumption. Federal law restricts this drug to use by or on the order 
of a licensed veterinarian.

[79 FR 16188, Mar. 25, 2014]



Sec. 522.960b  Flumethasone acetate solution.

    (a) Specifications. Each milliliter of solution contains 2 
milligrams (mg) of flumethasone acetate.
    (b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in dogs--(1) Amount. Administer by 
intramuscular injection as follows: Dogs weighing up to 10 pounds (lbs): 
2 mg; dogs weighing 10 to 25 lbs: 4 mg; dogs weighing over 25 lbs: 8 mg. 
Dosage should be adjusted according to the weight of the animal, the 
severity of the symptoms, and the response noted. Dosage by injection 
should not exceed 3 days of therapy. With chronic conditions 
intramuscular therapy may be followed by oral administration of 
flumethasone tablets at a daily dose of from 0.0625 to 0.25 mg per 
animal.
    (2) Indications for use. For use in certain acute and chronic canine 
dermatoses of varying etiology to help control the pruritus, irritation, 
and inflammation associated with these conditions.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[79 FR 16188, Mar. 25, 2014]



Sec. 522.960c  Flumethasone solution.

    (a) Specifications. Each milliliter of solution contains 0.5 
milligrams (mg) of flumethasone.
    (b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use. It is used as follows:

[[Page 296]]

    (1) Horses--(i) Amount. Administer 1.25 to 2.5 milligrams (mg) daily 
by intravenous, intramuscular, or intra-articular injection.
    (ii) Indications for use. For use in the treatment of 
musculoskeletal conditions due to inflammation, where permanent 
structural changes do not exist, e.g., bursitis, carpitis, osselets, and 
myositis; and allergic states, e.g., hives, urticaria, and insect bites.
    (iii) Limitations. Do not use in horses intended for human 
consumption. Federal law restricts this drug to use by or on the order 
of a licensed veterinarian.
    (2) Dogs--(i) Amount. Administer 0.0625 to 0.25 mg daily by 
intravenous, intramuscular, or subcutaneous injection; 0.125 to 1.0 mg 
daily by intra-lesional injection, depending on the size and location of 
the lesion; or 0.166 to 1.0 mg daily by intra-articular injection, 
depending on the severity of the condition and the size of the involved 
joint.
    (ii) Indications for use. For use in the treatment of 
musculoskeletal conditions due to inflammation of muscles or joints and 
accessory structures where permanent structural changes do not exist, 
e.g., arthritis, osteoarthritis, disc syndrome, and myositis (in septic 
arthritis, appropriate antibacterial therapy should be concurrently 
administered); certain acute and chronic dermatoses of varying etiology 
to help control associated pruritus, irritation, and inflammation; 
otitis externa in conjunction with topical medication; allergic states, 
e.g., hives, urticaria, and insect bites; and shock and shock-like 
states by intravenous administration.
    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.
    (3) Cats--(i) Amount. Administer 0.03125 to 0.125 mg daily by 
intravenous, intramuscular, or subcutaneous injection.
    (ii) Indications for use. For use in the treatment of certain acute 
and chronic dermatoses of varying etiology to help control associated 
pruritus, irritation, and inflammation.
    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

[79 FR 16188, Mar. 25, 2014]



Sec. 522.970  Flunixin.

    (a) Specifications. Each milliliter of solution contains flunixin 
meglumine equivalent to 50 milligrams (mg) flunixin.
    (b) Sponsors. See sponsors in Sec. 510.600(c) of this chapter for 
use as in paragraph (e) of this section.
    (1) See Nos. 000061, 016592, 055529, 058198, and 061133 for use as 
in paragraph (e) of this section.
    (2) See No. 054771 for use as in paragraph (e)(1) of this section.
    (c) Related tolerances. See Sec. 556.286 of this chapter.
    (d) Special considerations. Federal law restricts this drug to use 
by or on the order of a licensed veterinarian.
    (e) Conditions of use--(1) Horses--(i) Amount. 0.5 mg per pound (/
lb) of body weight per day, intravenously or intramuscularly, for up to 
5 days.
    (ii) Indications for use. For alleviation of inflammation and pain 
associated with musculoskeletal disorders, and alleviation of visceral 
pain associated with colic.
    (iii) Limitations. Do not use in horses intended for human 
consumption.
    (2) Cattle--(i) Amounts and indications for use--(A) Administer 1.1 
to 2.2 mg/kilogram (kg) (0.5 to 1.0 mg/lb) of body weight per day 
intravenously, as a single dose or divided into two doses administered 
at 12-hour intervals, for up to 3 days for control of pyrexia associated 
with bovine respiratory disease and endotoxemia or for control of 
inflammation in endotoxemia.
    (B) Administer 2.2 mg/kg (1.0 mg/lb) of body weight once 
intravenously for control of pyrexia associated with acute bovine 
mastitis.
    (ii) Limitations. Approved only for intravenous administration in 
cattle. Intramuscular administration has resulted in violative residues 
in the edible tissues of cattle sent to slaughter. Cattle must not be 
slaughtered for human consumption within 4 days of last treatment. Milk 
that has been taken during treatment and for 36 hours after the last 
treatment must not be used for food. Do not use in dry dairy cows. A 
withdrawal period has not been established for use in preruminating 
calves. Do not use in calves to be processed for veal.
    (B) [Reserved]

[[Page 297]]

    (3) Swine--(i) Amount. Administer 2.2 mg/kg (1.0 mg/lb) of body 
weight as a single intramuscular injection.
    (ii) Indications for use. For the control of pyrexia associated with 
swine respiratory disease.
    (iii) Limitations. Swine must not be slaughtered for human 
consumption within 12 days of last treatment.

[42 FR 39103, Aug. 2, 1977, as amended at 52 FR 7832, Mar. 13, 1987; 60 
FR 54942, Oct. 27, 1995; 62 FR 22888, Apr. 28, 1997; 63 FR 38749, July 
20, 1998; 67 FR 9400, Mar. 1, 2002; 68 FR 70701, Dec. 19, 2003; 69 FR 
53618, Sept. 2, 2004; 69 FR 60308, Oct. 8, 2004; 70 FR 48868, Aug. 22, 
2005; 70 FR 70998, Nov. 25, 2005; 71 FR 15564, Mar. 29, 2006; 71 FR 
16222, Mar. 31, 2006; 73 FR 2809, Jan. 16, 2008; 73 FR 28037, May 15, 
2008; 74 FR 6994, Feb. 12, 2009; 74 FR 34236, July 15, 2009; 75 FR 
13225, Mar. 19, 2010; 75 FR 76260, Dec. 8, 2010; 79 FR 16189, Mar. 25, 
2014; 82 FR 43484, Sept. 18, 2017; 83 FR 48946, Sept. 28, 2018; 84 FR 
8973, Mar. 13, 2019; 86 FR 14819, Mar. 19, 2021]



Sec. 522.995  Fluprostenol.

    (a) Specifications. Each milliliter of solution contains 
fluprostenol sodium equivalent to 50 micrograms ([micro]g) of 
fluprostenol.
    (b) Sponsor. See No. 058198 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in horses--(1) Amount. Administer 0.55 
[micro]g fluprostenol per kilogram of body weight by intramuscular 
injection.
    (2) Indications for use. For use in mares for its luteolytic effect 
to control the timing of estrus in estrous cycling and in clinically 
anestrous mares that have a corpus luteum.
    (3) Limitations. Do not use in horses intended for human 
consumption. Federal law restricts this drug to use by or on the order 
of a licensed veterinarian.

[79 FR 16189, Mar. 25, 2014, as amended at 86 FR 14820, Mar. 19, 2021]



Sec. 522.1002  Follicle stimulating hormone.

    (a)(1) Specifications. Each package contains 2 vials. One vial 
contains dry, powdered, porcine pituitary gland equivalent to 75 units 
(NIH-FSH-S1) of follicle stimulating hormone. The other vial contains 10 
milliliters of aqueous diluent.
    (2) Sponsor. See No. 052923 in Sec. 510.600(c) of this chapter.
    (3) Conditions of use--(i) Dosage. 12.5 units of follicle 
stimulating hormone twice a day for 3 days (a total of 75 units). To 
effect regression of the corpus luteum, prostaglandin should be given 
with the 5th dose.
    (ii) Indications for use. For induction of superovulation in cows 
for procedures requiring the production of multiple ova at a single 
estrus.
    (iii) Limitations. For intramuscular use in cows that are not 
pregnant and have a normal corpus luteum. Federal law restricts this 
drug to use by or on the order of a licensed veterinarian.
    (b)(1) Specifications--(i) Single pack. Each package contains 2 
vials. One vial contains 700 international units (IU) porcine-pituitary-
derived follicle stimulating hormone (FSH) equivalent to 400 milligrams 
NIH-FSH-P1, as a dry powder. The other vial contains 20 milliliters (mL) 
of bacteriostatic sodium chloride injection. When constituted, each 
milliliter of solution contains 35 IU FSH.
    (ii) Dual pack. Each package contains 2 vials. Each vial contains 
700 international units (IU) porcine-pituitary-derived FSH equivalent to 
400 milligrams NIH-FSH-P1, as a dry powder. Constitute with 20 mL 
bacteriostatic sodium chloride injection, using strict aseptic 
technique. When constituted, each milliliter of solution contains 35 IU 
FSH.
    (2) Sponsor. See No. 017030 in Sec. 510.600(c) of this chapter.
    (3) Conditions of use--(i) Dosage. Administer 2.5 mL (87.5 IU) 
intramuscularly, twice daily at 12-hour intervals, for 4 consecutive 
days. In conjunction with the 6th dose, administer an approved 
prostaglandin product for cattle (cloprostenol sodium or dinoprost 
tromethamine), using the labeled dosage and administration instructions 
to cause luteolysis and induce estrus. See Sec. 522.460 for use of 
cloprostenol sodium or Sec. 522.690 for use of dinoprost tromethamine.
    (ii) Indications for use. For the induction of superovulation in 
beef and dairy heifers and cows.

[[Page 298]]

    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

[58 FR 47377, Sept. 9, 1993, as amended at 62 FR 62242, Nov. 21, 1997; 
76 FR 2808, Jan. 18, 2011; 79 FR 53136, Sept. 8, 2014; 79 FR 74020, Dec. 
15, 2014; 82 FR 21690, May 10, 2017; 82 FR 43484, Sept. 18, 2017]



Sec. 522.1010  Furosemide.

    (a) Specifications. (1) Each milliliter (mL) of solution contains 50 
milligrams (mg) furosemide monoethanolamine.
    (2) Each mL of solution contains 50 mg furosemide diethanolamine.
    (b) Sponsors. See sponsors in Sec. 510.600(c) of this chapter for 
use of products described in paragraph (a) of this section for use as in 
paragraph (d) of this section.
    (1) No. 000010 as described in paragraph (a)(1) of this section for 
use as in paragraphs (d)(1) and (d)(2)(ii) of this section.
    (2) No. 061133 as described in paragraph (a)(2) of this section for 
use as in paragraph (d)(2)(ii) of this section.
    (3) No. 058198 as described in paragraph (a)(2) of this section for 
use as in paragraphs (d)(1), (d)(2)(i), and (d)(3) of this section.
    (4) No. 000061 as described in paragraph (a)(2) for use as in 
paragraphs (d)(1), (d)(2)(iii), and (d)(3) of this section.
    (c) Special considerations. Federal law restricts this drug to use 
by or on the order of a licensed veterinarian.
    (d) Conditions of use--(1) Dogs and cats--(i) Amount. 1.25 to 2.5 mg 
per pound (/lb) body weight once or twice daily, intramuscularly or 
intravenously.
    (ii) Indications for use. For the treatment of edema (pulmonary 
congestion, ascites) associated with cardiac insufficiency and acute 
noninflammatory tissue edema.
    (2) Horses--(i) Amount. 250 to 500 mg per animal once or twice 
daily, intramuscularly or intravenously.
    (A) Indications for use. For the treatment of edema (pulmonary 
congestion, ascites) associated with cardiac insufficiency, and acute 
noninflammatory tissue edema.
    (B) Limitations. Do not use in horses intended for human 
consumption.
    (ii) Amount. 0.5 mg/lb body weight once or twice daily, 
intramuscularly or intravenously.
    (A) Indications for use. For treatment of acute noninflammatory 
tissue edema.
    (B) Limitations. Do not use in horses intended for human 
consumption.
    (iii) Amount. 250 to 500 mg/animal once or twice daily, 
intramuscularly or intravenously.
    (A) Indications for use. For the treatment of edema (pulmonary 
congestion, ascites) associated with cardiac insufficiency, and acute 
noninflammatory tissue edema.
    (B) Limitations. Do not use in horses intended for human 
consumption.
    (3) Cattle--(i) Amount. 500 mg/animal once daily, intramuscularly or 
intravenously; or 250 mg/animal twice daily at 12-hour intervals, 
intramuscularly or intravenously.
    (ii) Indications for use. For the treatment of physiological 
parturient edema of the mammary gland and associated structures.
    (iii) Limitations. Treatment not to exceed 48 hours post-
parturition. Milk taken during treatment and for 48 hours (four 
milkings) after the last treatment must not be used for food. Cattle 
must not be slaughtered for food within 48 hours following last 
treatment.

[66 FR 47961, Sept. 17, 2001, as amended at 67 FR 18086, Apr. 15, 2002; 
68 FR 59881, Oct. 20, 2003; 69 FR 17585, Apr. 5, 2004; 71 FR 39548, July 
13, 2006; 74 FR 61516, Nov. 25, 2009; 76 FR 17338, Mar. 29, 2011; 78 FR 
17597, Mar. 22, 2013; 79 FR 16189, Mar. 25, 2014; 84 FR 8973, Mar. 13, 
2019; 86 FR 14820, Mar. 19, 2021]



Sec. 522.1014  Gamithromycin.

    (a) Specifications. Each milliliter (mL) of solution contains 150 
milligrams (mg) gamithromycin.
    (b) Sponsor. See No. 000010 in Sec. 510.600(c) of this chapter.
    (c) Related tolerances. See Sec. 556.292 of this chapter.
    (d) Conditions of use--(1) Cattle--(i) Amount. Administer 6 mg/
kilogram of body weight (2 mL per 110 pounds) one time by subcutaneous 
injection in the neck.
    (ii) Indications for use. For the treatment of bovine respiratory 
disease (BRD) associated with Mannheimia

[[Page 299]]

haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma 
bovis in beef and non-lactating dairy cattle; and for the control of 
respiratory disease in beef and non-lactating dairy cattle at high risk 
of developing BRD associated with M. haemolytica and P. multocida.
    (iii) Limitations. Cattle intended for human consumption must not be 
slaughtered within 35 days from the last treatment. Do not use in female 
dairy cattle 20 months of age or older. A withdrawal period has not been 
established for this product in preruminating calves. Do not use in 
calves to be processed for veal. Federal law restricts this drug to use 
by or on the order of a licensed veterinarian.
    (2) [Reserved]

[76 FR 57906, Sept. 19, 2011, as amended at 77 FR 26162, May 3, 2012; 84 
FR 39184, Aug. 9, 2019]



Sec. 522.1020  Gelatin.

    (a) Specifications. Each 100 milliliters contains 8 grams of gelatin 
in a 0.85 percent sodium chloride solution.
    (b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use--(1) Amount. The exact dosage to be 
administered must be determined after evaluating the animal's condition 
and will vary according to the size of the animal and the degree of 
shock. A suggested dosage range for small animals such as dogs is 4 to 8 
cubic centimeters per pound body weight. The suggested dosage range for 
large animals such as sheep, calves, cows, or horses is 2 to 4 cubic 
centimeters per pound of body weight.
    (2) Indications for use. For use to restore circulatory volume and 
maintain blood pressure in animals being treated for shock.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[79 FR 16189, Mar. 25, 2014]



Sec. 522.1044  Gentamicin.

    (a) Specifications. Each milliliter of solution contains gentamicin 
sulfate equivalent to 5, 50, or 100 milligrams (mg) gentamicin.
    (b) Sponsors. See sponsors in Sec. 510.600(c) of this chapter for 
use as in paragraph (d) of this section.
    (1) No. 000061 for use of 5 mg per milliliter (/mL) solution in 
swine as in paragraph (d)(4), 50 mg/mL solution in dogs and cats as in 
paragraph (d)(1), 50 mg/mL and 100 mg/mL solution in chickens and 
turkeys as in paragraphs (d)(2) and (d)(3) of this section.
    (2) No. 058005 for use of 5 mg/mL solution in swine as in paragraph 
(d)(4) of this section.
    (3) No. 069043 for use of 50 mg/mL solution in dogs as in paragraph 
(d)(5) of this section.
    (4) Nos. 016592 and 061133 for use of 100 mg/mL solution in turkeys 
as in paragraph (d)(2) and in chickens as in paragraph (d)(3) of this 
section.
    (c) Related tolerances. See Sec. 556.300 of this chapter.
    (d) Conditions of use--(1) Dogs and cats--(i) Amount. Two milligrams 
of gentamicin per pound of body weight, twice daily on the first day, 
once daily thereafter, using a 50 milligram-per-milliliter solution.
    (ii) Indications for use--(a) Dogs. For the treatment of infections 
of urinary tract (cystitis, nephritis), respiratory tract (tonsillitis, 
pneumonia, tracheobronchitis), skin and soft tissue (pyodermatitis, 
wounds, lacerations, peritonitis).
    (b) Cats. For the treatment of infections of urinary tract 
(cystitis, nephritis), respiratory tract (pneumonitis, pneumonia, upper 
respiratory tract infections), skin and soft tissue (wounds, 
lacerations, peritonitis), and as supportive therapy for secondary 
bacterial infections associated with panleucopenia.
    (iii) Limitations. Administer intramuscularly or subcutaneously. If 
response is not noted after 7 days, the antibiotic sensitivity of the 
infecting organism should be retested. Federal law restricts this drug 
to use by or on the order of a licensed veterinarian.
    (2) Turkeys--(i) Amount. One milligram of gentamicin per 0.2 
milliliter dose, using the 50- or 100-milligrams-per-milliliter product 
diluted with sterile saline to a concentration of 5 milligrams-per-
milliliter.
    (ii) Indications for use. As an aid in the prevention of early 
mortality due

[[Page 300]]

to Arizona paracolon infections susceptible to gentamicin.
    (iii) Limitations. For 1- to 3-day old turkey poults. Administer 
subcutaneously in the neck. Injected poults must not be slaughtered for 
food for at least 9 weeks after treatment.
    (3) Chickens--(i) Amount. 0.2 milligram of gentamicin per 0.2 
milliliter dose, using the 50- or 100-milligrams-per-milliliter product 
diluted with sterile saline to a concentration of 1.0 milligram-per-
milliliter.
    (ii) Indications for use. In day-old chickens, for prevention of 
early mortality caused by Escherichia coli. Salmonella typhimurium, and 
Pseudomonas aeruginosa that are susceptible to gentamicin.
    (iii) Limitations. For use in day-old chickens only. Administer 
aseptically, injecting the diluted product subcutaneously in the neck. 
Do not slaughter treated animals for food for at least 5 weeks after 
treatment.
    (4) Swine--(i) Amount. 5 milligrams of gentamicin as a single 
intramuscular dose using 5 milligram-per-milliliter solution.
    (ii) Indications for use. In piglets up to 3 days old for treatment 
of porcine colibacillosis caused by strains of E. coli sensitive to 
gentamicin.
    (iii) Limitations. For single intramuscular dose in pigs up to 3 
days of age only. Do not slaughter treated animals for food for at least 
40 days following treatment.
    (5) Dogs--(i) Amount. 2 milligrams of gentamicin per pound of body 
weight, twice daily on the first day, then once daily.
    (ii) Indications for use. For use in the treatment of urinary tract 
infections (cystitis) caused by Proteus mirabilis, Escherichia coli, and 
Staphylococcus aureus.
    (iii) Limitations. Administer intramuscularly or subcutaneously. If 
no improvement is seen after 3 days, treatment should be discontinued 
and the diagnosis reevaluated. Treatment not to exceed 7 days. Federal 
law restricts this drug to use by or on the order of a licensed 
veterinarian.

[43 FR 1942, Jan. 13, 1978, as amended at 48 FR 791, Jan. 7, 1983; 51 FR 
15606, Apr. 25, 1986; 52 FR 7832, Mar. 13, 1987; 53 FR 40727, Oct. 18, 
1988; 60 FR 29985, June 7, 1995; 61 FR 24441, May 15, 1996; 62 FR 45157, 
Aug. 26, 1997; 63 FR 59714, Nov. 5, 1998; 63 FR 68182, Dec. 10, 1998; 65 
FR 45877, July 26, 2000; 71 FR 76901, Dec. 22, 2006; 78 FR 17597, Mar. 
22, 2013; 78 FR 21060, Apr. 9, 2013; 79 FR 21127, Apr. 15, 2014; 81 FR 
22524, Apr. 18, 2016; 83 FR 48946, Sept. 28, 2018; 84 FR 8973, Mar. 13, 
2019]



Sec. 522.1055  Gleptoferron.

    (a) Specifications. Each milliliter (mL) contains the equivalent of 
200 milligrams of elemental iron as gleptoferron, a complex of ferric 
hydroxide and dextran glucoheptonic acid.
    (b) Sponsors. See No. 013744 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in swine--(1) Indications for use and amounts. 
(i) Prevention of anemia due to iron deficiency: Administer 1 mL (200 mg 
iron) per pig by intramuscular injection on or before 3 days of age.
    (ii) Treatment of anemia due to iron deficiency: Administer 1 mL 
(200 mg iron) per pig by intramuscular injection as soon as signs of 
deficiency appear.
    (2) [Reserved]

[81 FR 59134, Aug. 29, 2016, as amended at 82 FR 11508, Feb. 24, 2017; 
82 FR 21690, May 10, 2017]



Sec. 522.1066  Glycopyrrolate.

    (a) Specifications. Each milliliter of solution contains 0.2 
milligram glycopyrrolate.
    (b) Sponsors. See Nos. 054771 and 069043 in Sec. 510.600(c) of this 
chapter.
    (c) Conditions of use in dogs and cats--(1) Amount. 5 micrograms per 
pound of body weight (0.25 milliliter per 10 pounds of body weight) by 
intravenous, intramuscular, or subcutaneous injection in dogs or by 
intramuscular injection in cats.
    (2) Indications for use. As a preanesthetic agent.

[[Page 301]]

    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[71 FR 64451, Nov. 2, 2006, as amended at 78 FR 17597, Mar. 22, 2013; 79 
FR 16189, Mar. 25, 2014; 81 FR 17608, Mar. 30, 2016]



Sec. 522.1077  Gonadorelin.

    (a) Specifications. Each milliliter (mL) of solution contains:
    (1) 43 micrograms ([micro]g) of gonadorelin as gonadorelin acetate;
    (2) 100 [micro]g of gonadorelin as gonadorelin acetate;
    (3) 50 [micro]g of gonadorelin as gonadorelin diacetate tetrahydrate 
(equivalent to 43 [micro]g gonadorelin); or
    (4) 50 [micro]g of gonadorelin as gonadorelin hydrochloride.
    (b) Sponsors. See sponsor numbers in Sec. 510.600(c) of this 
chapter.
    (1) No. 000061 for use of the 43-[micro]g/mL product described in 
paragraph (a)(1) as in paragraphs (e)(1)(i) and (iii) of this section.
    (2) No. 068504 for use of the 100-[micro]g/mL product described in 
paragraph (a)(2) as in paragraph (e)(1)(iv) of this section.
    (3) Nos. 000010 and 061133 for use of the 50-[micro]g/mL product 
described in paragraph (a)(3) of this section as in paragraphs (e)(1)(i) 
and (v) of this section.
    (4) No. 054771 for use of the 50-[micro]g/mL product described in 
paragraph (a)(4) as in paragraphs (e)(1)(ii) and (vi) of this section.
    (c) Related tolerances. See Sec. 556.304 of this chapter.
    (d) Special considerations. (1) Concurrent luteolytic drug use is 
approved as follows:
    (i) Cloprostenol injection for use as in paragraph (e)(1)(iii) of 
this section as provided by No. 000061 in Sec. 510.600(c) of this 
chapter.
    (ii) Cloprostenol injection for use as in paragraph (e)(1)(iv) of 
this section as provided by No. 068504 in Sec. 510.600(c) of this 
chapter.
    (iii) Cloprostenol injection for use as in paragraph (e)(1)(v) of 
this section as provided by Nos. 000010 in Sec. 510.600(c) of this 
chapter.
    (iv) Dinoprost injection for use as in paragraphs (e)(1)(vi) of this 
section as provided by No. 054771 in Sec. 510.600(c) of this chapter.
    (2) Federal law restricts this drug to use by or on the order of a 
licensed veterinarian.
    (e) Conditions of use in cattle--(1) Indications for use and 
amounts. (i) For the treatment of ovarian follicular cysts in dairy 
cattle: Administer 86 [micro]g gonadorelin (No. 000061) or 100 [micro]g 
gonadorelin diacetate tetrahydrate (Nos. 000010 and 061133) by 
intramuscular or intravenous injection.
    (ii) For the treatment of ovarian follicular cysts in cattle: 
Administer 100 [micro]g gonadorelin hydrochloride by intramuscular 
injection.
    (iii) For use with cloprostenol sodium to synchronize estrous cycles 
to allow for fixed-time artificial insemination (FTAI) in beef cows and 
lactating dairy cows: Administer to each cow 86 [micro]g gonadorelin by 
intramuscular injection, followed 6 to 8 days later by 500 [micro]g 
cloprostenol by intramuscular injection, followed 30 to 72 hours later 
by 86 [micro]g gonadorelin by intramuscular injection.
    (iv) For use with cloprostenol sodium to synchronize estrous cycles 
to allow for fixed-time artificial insemination (FTAI) in lactating 
dairy cows and beef cows: Administer to each cow 100 [micro]g 
gonadorelin by intramuscular injection, followed 6 to 8 days later by 
500 [micro]g cloprostenol by intramuscular injection, followed 30 to 72 
hours later by 100 [micro]g gonadorelin by intramuscular injection.
    (v) For use with cloprostenol sodium to synchronize estrous cycles 
to allow for fixed-time artificial insemination (FTAI) in lactating 
dairy cows and beef cows: Administer to each cow 100 [micro]g 
gonadorelin diacetate tetrahydrate by intramuscular injection, followed 
6 to 8 days later by 500 [micro]g cloprostenol by intramuscular 
injection, followed 30 to 72 hours later by 100 [micro]g gonadorelin 
diacetate tetrahydrate by intramuscular injection.
    (vi) For use with dinoprost injection to synchronize estrous cycles 
to allow fixed-time artificial insemination (FTAI) in lactating dairy 
cows: Administer to each cow 100 to 200 [micro]g gonadorelin by 
intramuscular injection, followed 6 to 8 days later by 25 mg dinoprost 
by intramuscular injection, followed 30 to 72 hours later by 100 to

[[Page 302]]

200 [micro]g gonadorelin by intramuscular injection.
    (2) [Reserved]

[83 FR 64740, Dec. 18, 2018, as amended at 84 FR 8973, Mar. 13, 2019; 84 
FR 39184, Aug. 9, 2019; 84 FR 32992, July 11, 2019; 86 FR 13184, Mar. 8, 
2021; 86 FR 14820, Mar. 19, 2021]



Sec. 522.1079  Serum gonadotropin and chorionic gonadotropin.

    (a) Specifications. Each dose consists of 400 international units 
(I.U.) serum gonadotropin and 200 I.U. chorionic gonadotropin as a 
freeze-dried powder to be reconstituted with 5 milliliters of sterile 
aqueous diluent.
    (b) Sponsor. See No. 000061 in Sec. 510.600(c) of this chapter.
    (c) Related tolerances. See Sec. 556.304 of this chapter.
    (d) Conditions of use in swine--(1) Amount. 400 I.U. serum 
gonadotropin with 200 I.U. chorionic gonadotropin per 5 milliliters dose 
per animal.
    (2) Indications for use--(i) Gilts. For induction of fertile estrus 
(heat) in healthy prepuberal (noncycling) gilts.
    (ii) Sows. For induction of estrus in healthy weaned sows 
experiencing delayed return to estrus.
    (3) Limitations. For subcutaneous use only.
    (i) Gilts. For use only in gilts over 5\1/2\ months of age and 
weighing at least 85 kilograms (187 pounds).
    (ii) Sows. Delayed return to estrus is most prevalent after the 
first litter. The effectiveness has not been established after later 
litters. Delayed return to estrus often occurs during periods of adverse 
environmental conditions, and sows mated under such conditions may 
farrow smaller than normal litters.

[55 FR 1405, Jan. 16, 1990, as amended at 58 FR 52222, Oct. 7, 1993; 74 
FR 61516, Nov. 25, 2009; 84 FR 32992, July 11, 2019]



Sec. 522.1081  Chorionic gonadotropin.

    (a) Specifications. Each vial contains 5,000, 10,000 or 20,000 USP 
units of lyophilized powder for constitution with accompanying diluent 
to a 10-milliliter solution.
    (b) Sponsors. See sponsors in Sec. 510.600(c) of this chapter for 
use as in paragraph (d) of this section.
    (1) No. 054771 for use as in paragraphs (d)(1)(i)(A), (d)(1)(i)(B) 
and (d)(1)(i)(C) of this section.
    (2) [Reserved]
    (3) No. 000061 for use as in paragraphs (d)(1)(i)(A) and (d)(2) of 
this section.
    (c) Related tolerances. See Sec. 556.304 of this chapter.
    (d) Conditions of use--(1) Cattle--(i) Amount. As a single dose. 
Dosage may be repeated in 14 days if the animal's behavior or 
examination of the ovaries per rectum indicates retreatment.
    (A) 10,000 USP units by intramuscular injection.
    (B) 500 to 2,500 USP units by intrafollicular injection.
    (C) 2,500 to 5,000 USP units by intravenous injection.
    (ii) Indications for use. For parenteral use in cows for treatment 
of nymphomania (frequent or constant heat) due to cystic ovaries.
    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.
    (2) Finfish--(i) Amount. 50 to 510 IU per pound of body weight for 
males, 67 to 1,816 IU per pound of body weight for females, by 
intramuscular injection. Up to three doses may be administered.
    (ii) Indications for use. An aid in improving spawning function in 
male and female brood finfish.
    (iii) Limitations. In fish intended for human consumption, the total 
dose administered per fish (all injections combined) should not exceed 
25,000 IU chorionic gonadotropin. Federal law restricts this drug to use 
by or on the order of a licensed veterinarian.

[74 FR 61516, Nov. 25, 2009, as amended at 76 FR 17778, Mar. 31, 2011; 
77 FR 55414, Sept. 10, 2012; 79 FR 16189, Mar. 25, 2014; 83 FR 13635, 
Mar. 30, 2018]



Sec. 522.1083  Gonadotropin releasing factor analog-diphtheria 
toxoid conjugate.

    (a) Specifications. Each milliliter (mL) of solution contains 0.2 
milligrams (mg) gonadotropin releasing factor analog-diphtheria toxoid 
conjugate.
    (b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in swine--(1) Amount. Each intact male pig or 
gilt should receive two 2-mL (0.4 mg) doses by subcutaneous injection. 
Administer

[[Page 303]]

the first dose no earlier than 9 weeks of age. Administer the second 
dose at least 4 weeks after the first dose.
    (2) Indications for use--(i) Intact male pigs intended for 
slaughter: For the temporary immunological castration (suppression of 
testicular function) and reduction of boar taint.
    (ii) Gilts intended for slaughter: For the temporary suppression of 
estrus.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian. For reduction of boar taint, intact 
male pigs should be slaughtered no earlier than 3 weeks and no later 
than 10 weeks after the second dose.

[76 FR 27889, May 13, 2011, as amended at 77 FR 4227, Jan. 27, 2012; 79 
FR 16189, Mar. 25, 2014; 85 FR 45308, July 28, 2020]



Sec. 522.1085  Guaifenesin powder for injection.

    (a) Specifications. The product is a sterile powder containing 
guaifenesin. A solution is prepared by dissolving the drug in sterile 
water for injection to make a solution containing 50 milligrams of 
guaifenesin per milliliter of solution.
    (b) Sponsors. See Nos. 037990 and 054771 in Sec. 510.600(c) of this 
chapter.
    (c) Conditions of use in horses--(1) Amount. Administer 1 milliliter 
of prepared solution per pound of body weight by rapid intravenous 
infusion.
    (2) Indications for use. For use as a muscle relaxant.
    (3) Limitations. Do not use in horses intended for human 
consumption. Federal law restricts this drug to use by or on the order 
of a licensed veterinarian.

[79 FR 16189, Mar. 25, 2014]



Sec. 522.1086  Guaifenesin solution.

    (a) Specifications. Each milliliter of solution contains 50 
milligrams (mg) of guaifenesin and 50 mg of dextrose.
    (b) Sponsors. See Nos. 037990 and 058198 in Sec. 510.600(c) of this 
chapter.
    (c) Conditions of use in horses--(1) Amount. Administer 1 milliliter 
per pound of body weight by rapid intravenous infusion.
    (2) Indications for use. For use as a skeletal muscle relaxant.
    (3) Limitations. Do not use in horses intended for human 
consumption. Federal law restricts this drug to use by or on the order 
of a licensed veterinarian.

[79 FR 16189, Mar. 25, 2014, as amended at 86 FR 14820, Mar. 19, 2021]



Sec. 522.1125  Hemoglobin glutamer-200 (bovine).

    (a) Specifications. Each 125 milliliter bag contains 13 grams per 
deciliter of polymerized hemoglobin of bovine origin in modified 
Lactated Ringer's Solution. It is a sterile, clear, dark purple 
solution.
    (b) Sponsor. See No. 063075 in Sec. 510.600(c) of this chapter.
    (c) [Reserved]
    (d) Conditions of use--(1) Amount. One-time dose of 10 to 30 
milliliters per kilogram of body weight administered intravenously at a 
rate of up to 10 milliliters per kilogram per hour.
    (2) Indications for use. For the treatment of anemia in dogs by 
increasing systemic oxygen content (plasma hemoglobin concentration) and 
improving the clinical signs associated with anemia, regardless of the 
cause of anemia (hemolysis, blood loss, or ineffective erythropoiesis).
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[63 FR 11598, Mar. 10, 1998, as amended at 65 FR 20732, Apr. 18, 2000; 
79 FR 16189, Mar. 25, 2014]



Sec. 522.1145  Hyaluronate.

    (a)(1) Specifications. Each milliliter of sterile aqueous solution 
contains 10 milligrams of hyaluronate sodium.
    (2) Sponsor. See 054771 in Sec. 510.600(c).
    (3) Conditions of use--(i) Amount. Small and medium-size joints 
(carpal, fetlock): 20 mg; larger joint (hock): 40 mg. Treatment may be 
repeated at weekly intervals for a total of three treatments.
    (ii) Indications for use. Treatment of joint dysfunction in horses 
due to noninfectious synovitis associated with equine osteoarthritis.
    (iii) Limitations. Do not use in horses intended for human 
consumption. Federal law restricts this drug to use by or on the order 
of a licensed veterinarian.
    (b)(1) Specifications. Each milliliter of sterile aqueous solution 
contains 5 milligrams of hyaluronate sodium.

[[Page 304]]

    (2) Sponsor. See 054771 in Sec. 510.600(c) of this chapter.
    (3) Conditions of use--(i) Amount. Small and medium-size joints 
(carpal, fetlock): 10 mg; larger joint (hock): 20 mg. Treatment may be 
repeated at weekly intervals for a total of four treatments.
    (ii) Indications for use. Treatment of joint dysfunction in horses 
due to noninfectious synovitis associated with equine osteoarthritis.
    (iii) Limitations. Do not use in horses intended for human 
consumption. Federal law restricts this drug to use by or on the order 
of a licensed veterinarian.
    (c)(1) Specifications. Each milliliter of sterile aqueous solution 
contains 10 milligrams of hyaluronate sodium.
    (2) Sponsor. See No. 000010 in Sec. 510.600(c) of this chapter.
    (3) Conditions of use--(i) Amount. Small and medium-size joints 
(carpal, fetlock): 20 mg. Treatment may be repeated after 1 or more 
weeks but not to exceed 2 injections per week for a total of 4 weeks.
    (ii) Indications for use. For the intra-articular treatment of 
carpal or fetlock joint dysfunction in horses due to acute or chronic, 
non-infectious synovitis associated with equine osteoarthritis.
    (iii) Limitations. Do not use in horses intended for human 
consumption. Federal law restricts this drug to use by or on the order 
of a licensed veterinarian.
    (d)(1) Specifications. Each milliliter of sterile aqueous solution 
contains 10 milligrams of hyaluronate sodium.
    (2) Sponsor. See 000061 in Sec. 510.600(c) of this chapter.
    (3) Conditions of use--(i) Amount. 50 milligrams in carpal and 
fetlock joints.
    (ii) Indications for use. For treatment of equine carpal and fetlock 
joint dysfunction caused by traumatic and/or degenerative joint disease 
of mild to moderate severity.
    (iii) Limitations. Do not use in horses intended for human 
consumption. Federal law restricts this drug to use by or on the order 
of a licensed veterinarian.
    (e)(1) Specifications. Each milliliter of solution contains:
    (i) 10 milligrams (mg) hyaluronate sodium; or
    (ii) 10 mg hyaluronate sodium with benzyl alcohol as a preservative.
    (2) Sponsors. See sponsors in Sec. 510.600(c) of this chapter:
    (i) No. 000010 for use of products described in paragraph (e)(1) as 
in paragraph (e)(3) of this section.
    (ii) No. 017030 for use of product described in paragraph (e)(1)(i) 
as in paragraph (e)(3) of this section.
    (3) Conditions of use--(i) Amount. 20 mg of the product described in 
paragraph (e)(1)(i) of this section by intra-articular injection into 
the carpus or fetlock; or 40 mg of the product described in paragraph 
(e)(1)(i) or (e)(1)(ii) of this section by slow intravenous injection 
into the jugular vein. Treatment may be repeated at weekly intervals for 
a total of three treatments.
    (ii) Indications for use. For treatment of carpal or fetlock joint 
dysfunction due to noninfectious synovitis associated with equine 
osteoarthritis.
    (iii) Limitations. Do not use in horses intended for human 
consumption. Federal law restricts this drug to use by or on the order 
of a licensed veterinarian.
    (f)(1) Specifications. Each milliliter of sterile aqueous solution 
contains 11 milligrams of hyaluronate sodium.
    (2) Sponsor. See 060865 in Sec. 510.600(c).
    (3) Conditions of use--(i) Amount. Small and medium-size joints 
(carpal, fetlock): 22 mg; larger joint (hock): 44 mg. Treatment may be 
repeated at weekly intervals for a total of three treatments.
    (ii) Indications for use. Treatment of joint dysfunction in horses 
due to noninfectious synovitis associated with equine osteoarthritis.
    (iii) Limitations. Do not use in horses intended for human 
consumption. Federal law restricts this drug to use by or on the order 
of a licensed veterinarian.

[49 FR 45124, Nov. 15, 1984, as amended at 51 FR 11438, Apr. 3, 1986; 51 
FR 25032, July 10, 1986; 53 FR 19773, May 31, 1988; 53 FR 22297, June 
15, 1988; 56 FR 50814, Oct. 9, 1991; 57 FR 2837, Jan. 24, 1992; 59 FR 
33198, June 28, 1994; 61 FR 59003, Nov. 20, 1996; 63 FR 59216, Nov. 3, 
1998; 71 FR 1689, Jan. 11, 2006; 71 FR 39204, July 12, 2006; 75 FR 1274, 
Jan. 11, 2010; 75 FR 10167, Mar. 5, 2010; 78 FR 73698, Dec. 9, 2013; 79 
FR 16189, Mar. 25, 2014; 79 FR 74020, Dec. 15, 2014; 80 FR 34279, June 
16, 2015; 84 FR 39184, Aug. 9, 2019]

[[Page 305]]



Sec. 522.1150  Hydrochlorothiazide.

    (a) Specifications. Each milliliter of solution contains 25 
milligrams of hydrochlorothiazide.
    (b) Sponsor. See No. 000010 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use--(1) Amount. 5 to 10 milliliters (125 to 250 
milligrams) intravenously or intramuscularly once or twice a day. After 
onset of diuresis, treatment may be continued with an orally 
administered maintenance dose.
    (2) Indications for use. For use in cattle as an aid in the 
treatment of postparturient udder edema.
    (3) Limitations. Milk taken from dairy animals during treatment and 
for 72 hours (6 milkings) after the latest treatment must not be used 
for food. Federal law restricts this drug to use by or on the order of a 
licensed veterinarian.

[43 FR 59058, Dec. 19, 1978, as amended at 62 FR 63271, Nov. 28, 1997; 
79 FR 16190, Mar. 25, 2014; 84 FR 39184, Aug. 9, 2019]



Sec. 522.1155  Imidocarb powder for injection.

    (a) Specifications. The product is a sterile powder containing 
imidocarb dipropionate. Each milliliter of constituted solution contains 
100 milligrams (mg) of imidocarb base.
    (b) Sponsor. See No. 000061 in Sec. 510.600(c) of this chapter.
    (c) Special considerations. Imidocarb dipropionate is sold only 
under permit issued by the Director of the National Program Planning 
Staff, Veterinary Services, Animal and Plant Health Inspection Service, 
U.S. Department of Agriculture, to licensed or full-time State, Federal, 
or military veterinarians.
    (d) Conditions of use in horses and zebras--(1) Amount. For Babesia 
caballi infections, administer 2 mg of imidocarb base per kilogram of 
body weight by intramuscular injection in the neck region, repeating 
dosage once after 24 hours. For Babesia equi infections, administer 4 mg 
of imidocarb base per kilogram of body weight by intramuscular injection 
in the neck region, repeating dosage four times at 72-hour intervals.
    (2) Indications for use. For the treatment of babesiosis 
(piroplasmosis) caused by Babesia caballi and Babesia equi.
    (3) Limitations. Do not use in horses intended for human 
consumption. Federal law restricts this drug to use by or on the order 
of a licensed veterinarian.

[79 FR 16190, Mar. 25, 2014]



Sec. 522.1156  Imidocarb solution.

    (a) Specifications. Each milliliter of solution contains 120 
milligrams (mg) of imidocarb dipropionate.
    (b) Sponsor. See No. 000061 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in dogs--(1) Amount. Administer 6.6 mg per 
kilogram (3 mg per pound) of body weight by intramuscular injection. 
Repeat the dose after 2 weeks for a total of two treatments.
    (2) Indications for use. For the treatment of clinical signs of 
babesiosis and/or demonstrated Babesia organisms in the blood.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[79 FR 16190, Mar. 25, 2014]



Sec. 522.1160  Insulin.

    (a) Specifications. (1) Each milliliter (mL) of porcine insulin zinc 
suspension contains 40 international units (IU) of insulin.
    (2) Each mL of protamine zinc recombinant human insulin suspension 
contains 40 IU of insulin.
    (b) Sponsors. See sponsors in Sec. 510.600 of this chapter for use 
as in paragraph (c) of this section.
    (1) No. 000061 for use of product described in paragraph (a)(1) as 
in paragraphs (c)(1)(i)(A), (c)(1)(ii), (c)(1)(iii), (c)(2)(i)(A), 
(c)(2)(ii), and (c)(2)(iii) of this section.
    (2) No. 000010 for use of product described in paragraph (a)(2) as 
in paragraphs (c)(1)(i)(B), (c)(1)(ii), (c)(1)(iii), (c)(2)(i)(B), 
(c)(2)(ii), and (c)(2)(iii) of this section.
    (c) Conditions of use--(1) Dogs--(i) Amount--(A) Porcine zinc 
insulin zinc. Administer an initial once-daily dose of 0.5 IU per 
kilogram of body weight by subcutaneous injection concurrently with or 
right after a meal. Adjust this once-daily dose at appropriate

[[Page 306]]

intervals based on clinical signs, urinalysis results, and glucose curve 
values until adequate glycemic control has been attained. Twice-daily 
therapy should be initiated if the duration of insulin action is 
determined to be inadequate. If twice-daily treatment is initiated, the 
two doses should be 25 percent less than the once daily dose required to 
attain an acceptable nadir.
    (B) Protamine zinc recombinant human insulin. Administer a starting 
dose of 0.2 to 0.5 IU/pound of body weight (0.5 to 1.0 IU/kg) once 
daily. When transitioning from another insulin product, this form of 
insulin should be started once daily, regardless of the frequency of 
prior insulin use. The dose should be given concurrently with or right 
after a meal. Reevaluate the dog at appropriate intervals and adjust the 
dose based on both clinical signs and laboratory test results until 
adequate glycemic control has been attained. Twice-daily therapy should 
be initiated if the duration of insulin action is determined to be 
inadequate. If twice-daily treatment is initiated, the two doses should 
be 25 percent less than the once daily dose required to attain an 
acceptable nadir.
    (ii) Indications for use. For the reduction of hyperglycemia and 
hyperglycemia-associated clinical signs in dogs with diabetes mellitus.
    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.
    (2) Cats--(i) Amount--(A) Porcine insulin zinc. Administer an 
initial dose of 1 to 2 IU by subcutaneous injection. Injections should 
be given twice daily at approximately 12-hour intervals. For cats fed 
twice daily, the injections should be concurrent with or right after a 
meal. For cats fed ad libitum, no change in feeding is needed. Adjust 
the dose at appropriate intervals based on clinical signs, urinalysis 
results, and glucose curve values until adequate glycemic control has 
been attained.
    (B) Protamine zinc recombinant human insulin. Administer an initial 
dose of 0.1 to 0.3 IU/pound of body weight (0.2 to 0.7 IU/kilogram) 
every 12 hours. The dose should be given concurrently with or right 
after a meal. Re-evaluate the cat at appropriate intervals and adjust 
the dose based on both clinical signs and glucose nadirs until adequate 
glycemic control has been attained.
    (ii) Indications for use. For the reduction of hyperglycemia and 
hyperglycemia-associated clinical signs in cats with diabetes mellitus.
    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

[69 FR 25827, May 10, 2004, as amended at 73 FR 21042, Apr. 18, 2008; 74 
FR 61517, Nov. 25, 2009; 74 FR 66048, Dec. 14, 2009; 84 FR 39184, Aug. 
9, 2019]



Sec. 522.1182  Iron injection.

    (a) Specifications. See Sec. 510.440 of this chapter. Each 
milliliter (mL) of solution contains the equivalent of:
    (1) 100 milligrams (mg) of elemental iron derived from:
    (i) Ferric hydroxide;
    (ii) Ferric oxide; or
    (iii) Elemental iron.
    (2) 200 mg of elemental iron derived from ferric hydroxide.
    (b) Sponsors and conditions of use. It is used in young piglets by 
sponsors in Sec. 510.600(c) of this chapter as follows:
    (1) Nos. 016592 and 042552 for use of product described in paragraph 
(a)(1)(i) of this section as follows:
    (i) For prevention of iron deficiency anemia, inject 100 mg (1 mL) 
by intramuscular injection at 2 to 4 days of age.
    (ii) For treatment of iron deficiency anemia, inject 100 mg (1 mL) 
by intramuscular injection. Dosage may be repeated in approximately 10 
days.
    (2) No. 054771 for use of product described in paragraph (a)(1)(i) 
of this section as follows:
    (i) For the prevention of anemia due to iron deficiency, administer 
an initial intramuscular injection of 100 mg at 2 to 4 days of age. 
Dosage may be repeated in 14 to 21 days.
    (ii) For the treatment of anemia due to iron deficiency, administer 
an intramuscular injection of 200 mg.
    (3) Nos. 000061 and 013744 for use of product described in paragraph 
(a)(1)(i) of this section as follows:
    (i) For the prevention of iron deficiency anemia, administer 
intramuscularly an amount of drug containing 100 to 150 mg of elemental 
iron to animals from 1 to 3 days of age.

[[Page 307]]

    (ii) For the treatment of iron deficiency anemia, administer 
intramuscularly an amount of drug containing 100 to 200 mg of elemental 
iron per animal. Dosage may be repeated in 10 days to 2 weeks.
    (4) No. 054771 for use of product described in paragraph (a)(1)(ii) 
of this section as follows:
    (i) For prevention of iron deficiency anemia, administer 1 mL by 
intramuscular injection at 2 to 5 days of age. Dosage may be repeated at 
2 weeks of age.
    (ii) For treatment of iron deficiency anemia, administer 1 to 2 mL 
by intramuscular injection at 5 to 28 days of age.
    (5) No. 054771 for use of product described in paragraph (a)(1)(iii) 
of this section as follows:
    (i) For prevention of anemia due to iron deficiency, administer 100 
mg by intramuscular or subcutaneous injection at 2 to 4 days of age.
    (ii) For treatment of anemia due to iron deficiency, administer 100 
mg by intramuscular or subcutaneous injection up to 4 weeks of age.
    (6) Nos. 016592 and 058005 for use of product described in paragraph 
(a)(1)(iii) of this section as follows:
    (i) For prevention of anemia due to iron deficiency, administer 100 
mg by intramuscular injection at 2 to 4 days of age.
    (ii) For treatment of anemia due to iron deficiency, administer 100 
mg by intramuscular injection. Treatment may be repeated in 10 days.
    (7) Nos. 016592 and 042552 for use of product described in paragraph 
(a)(2) of this section as follows:
    (i) For prevention of anemia due to iron deficiency, intramuscularly 
inject 200 mg of elemental iron (1 mL) at 1 to 3 days of age.
    (ii) For treatment of anemia due to iron deficiency, intramuscularly 
inject 200 mg of elemental iron at the first sign of anemia.

[73 FR 12635, Mar. 10, 2008, as amended at 73 FR 14385, Mar. 18, 2008; 
78 FR 17597, Mar. 22, 2013; 78 FR 44433, July 24, 2013; 79 FR 16190, 
Mar. 25, 2014; 81 FR 22524, Apr. 18, 2016; 81 FR 59134, Aug. 29, 2016; 
82 FR 11508, Feb. 24, 2017; 83 FR 48946, Sept. 28, 2018; 86 FR 14820, 
Mar. 19, 2021]



Sec. 522.1185  Isoflupredone.

    (a) Specifications. Each milliliter of suspension contains 2 
milligrams (mg) of isoflupredone acetate.
    (b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use--(1) Cattle--(i) Amount. Administer 10 to 20 
mg by intramuscular injection.
    (ii) Indications for use. For use in the treatment of bovine 
ketosis. For alleviation of pain associated with generalized and acute 
localized arthritic conditions; for treating acute hypersensitivity 
reactions; and as an aid in correcting circulatory defects associated 
with severe toxicity and shock.
    (iii) Limitations. Animals intended for human consumption should not 
be slaughtered within 7 days of last treatment. A withdrawal period has 
not been established for this product in preruminating calves. Do not 
use in calves to be processed for veal. Federal law restricts this drug 
to use by or on the order of a licensed veterinarian.
    (2) Horses and swine--(i) Amount--(A) Horses. Administer 5 to 20 mg 
by intramuscular injection for systemic effect or by intrasynovial 
injection into a joint cavity, tendon sheath, or bursa for local effect.
    (B) Swine. The usual dose for a 300-pound animal is 5 mg by 
intramuscular injection.
    (ii) Indications for use. For alleviation of pain associated with 
generalized and acute localized arthritic conditions; for treating acute 
hypersensitivity reactions; and as an aid in correcting circulatory 
defects associated with severe toxicity and shock.
    (iii) Limitations. Animals intended for human consumption should not 
be slaughtered within 7 days of last treatment. Federal law restricts 
this drug to use by or on the order of a licensed veterinarian.

[79 FR 16190, Mar. 25, 2014]



Sec. 522.1192  Ivermectin.

    (a) Specifications. (1) Each milliliter (mL) of solution contains 20 
milligrams (mg) ivermectin.
    (2) Each mL of solution contains 10 mg ivermectin.
    (3) Each mL of solution contains 2.7 mg ivermectin.

[[Page 308]]

    (b) Sponsors. See sponsors in Sec. 510.600(c) of this chapter for 
use as in paragraph (e) of this section.
    (1) No. 000010 for use of the product described in paragraph (a)(1) 
of this section as in paragraph (e)(1) of this section; the product 
described in paragraph (a)(2) of this section as in paragraphs (e)(2), 
(e)(3), (e)(4), and (e)(5) of this section; and the product described in 
paragraph (a)(3) of this section as in paragraphs (e)(3) and (e)(6) of 
this section.
    (2) Nos. 016592, 055529, 058005, and 061133 for use of the product 
described in paragraph (a)(2) of this section as in paragraphs (e)(2), 
(e)(3), (e)(4), and (e)(5) of this section.
    (c) Related tolerances. See Sec. 556.344 of this chapter.
    (d) Special considerations. (1) See Sec. 500.25 of this chapter.
    (2) Labeling shall bear the following precaution: ``This product 
should not be used in other animal species as severe adverse reactions, 
including fatalities in dogs, may result.''
    (e) Conditions of use--(1) Horses--(i) Amount. 200 micrograms per 
kilogram ([micro]g/kg) of body weight by intramuscular injection.
    (ii) Indications for use. For the treatment and control of large 
strongyles (adult) (Strongylus vulgaris, S. edentatus, Triodontophorus 
spp.), small strongyles (adult and fourth stage larvae) (Cyathostomum 
spp., Cylicocyclus spp., Cylicostephanus spp.), pinworms (adult and 
fourth-stage larvae) (Oxyuris equi), large roundworms (adult) 
(Parascaris equorum), hairworms (adult) (Trichostrongylus axei), large 
mouth stomach worms (adult) (Habronema muscae), neck threadworms 
(microfilariae) (Onchocerca spp.), and stomach bots (Gastrophilus spp.).
    (iii) Limitations. Not for use in horses intended for human 
consumption. Federal law restricts this drug to use by or on the order 
of a licensed veterinarian.
    (2) Cattle--(i) Amount. 200 [micro]g/kg of body weight by 
subcutaneous injection.
    (ii) Indications for use. For the treatment and control of 
gastrointestinal nematodes (adults and fourth-stage larvae) (Haemonchus 
placei, Ostertagia ostertagi (including inhibited larvae), O. lyrata, 
Trichostrongylus axei, T. colubriformis, Cooperia oncophora, C. 
punctata, C. pectinata, Oesophagostomum radiatum, Nematodirus 
helvetianus (adults only), N. spathiger (adults only), Bunostomum 
phlebotomum); lungworms (adults and fourth-stage larvae) (Dictyocaulus 
viviparus); grubs (parasitic stages) (Hypoderma bovis, H. lineatum); 
sucking lice (Linognathus vituli, Haematopinus eurysternus, Solenopotes 
capillatus); mites (scabies) (Psoroptes ovis (syn. P. communis var. 
bovis), Sarcoptes scabiei var. bovis). For control of infections and to 
protect from reinfection with D. viviparus and O. radiatum for 28 days 
after treatment; O. ostertagi, T. axei, and C. punctata for 21 days 
after treatment; H. placei and C. oncophora for 14 days after treatment.
    (iii) Limitations. Do not treat cattle within 35 days of slaughter. 
Because a withdrawal time in milk has not been established, do not use 
in female dairy cattle of breeding age. A withdrawal period has not been 
established for this product in pre-ruminating calves. Do not use in 
calves to be processed for veal.
    (3) Swine--(i) Amount. 300 [micro]g/kg of body weight by 
subcutaneous injection.
    (ii) Indications for use. For the treatment and control of 
gastrointestinal roundworms (adults and fourth-stage larvae) (large 
roundworm, Ascaris suum; red stomach worm, Hyostrongylus rubidus; 
nodular worm, Oesophagostomum spp.; threadworm, Strongyloides ransomi 
(adults only)); somatic roundworm larvae (threadworm, S. ransomi 
(somatic larvae)); lungworms (Metastrongylus spp. (adults only)); lice 
(H. suis); and mites (S. scabiei var. suis).
    (iii) Limitations. Do not treat swine within 18 days of slaughter.
    (4) American bison--(i) Amount. 200 [micro]g/kg of body weight by 
subcutaneous injection.
    (ii) Indications for use. For the treatment and control of grubs (H. 
bovis).
    (iii) Limitations. Do not slaughter within 56 days of last 
treatment.
    (5) Reindeer--(i) Amount. 200 [micro]g/kg of body weight by 
subcutaneous injection.
    (ii) Indications for use. For the treatment and control of warbles 
(Oedemagena tarandi).
    (iii) Limitations. Do not treat reindeer within 56 days of 
slaughter.

[[Page 309]]

    (6) Ranch-raised foxes--(i) Amount. 200 [micro]g/kg of body weight 
by subcutaneous injection. Repeat in 3 weeks.
    (ii) Indications for use. For treatment and control of ear mites 
(Otodectes cynotis).

[72 FR 27735, May 17, 2007, as amended at 72 FR 62771, Nov. 7, 2007; 74 
FR 9049, Mar. 2, 2009; 75 FR 26647, May 12, 2010; 76 FR 57906, Sept. 19, 
2011; 78 FR 17597, Mar. 22, 2013; 81 FR 59134, Aug. 29, 2016; 84 FR 
8974, Mar. 13, 2019; 84 FR 32992, July 11, 2019; 84 FR 39184, Aug. 9, 
2019]



Sec. 522.1193  Ivermectin and clorsulon.

    (a) Specifications. Each milliliter (mL) of solution contains 10 
milligrams (mg) (1 percent) ivermectin and 100 mg (10 percent) 
clorsulon.
    (b) Sponsors. See Nos. 000010, 055529, 058005, and 061133 in Sec. 
510.600(c) of this chapter.
    (c) Related tolerances. See Sec. Sec. 556.163 and 556.344 of this 
chapter.
    (d) Special considerations. See Sec. 500.25 of this chapter.
    (e) Conditions of use in cattle--(1) Amount. Administer 1 mL (10 mg 
ivermectin and 100 mg clorsulon) per 50 kilograms (110 pounds) by 
subcutaneous injection.
    (2) Indications for use. For the treatment and control of 
gastrointestinal nematodes (adults and fourth-stage larvae) (Haemonchus 
placei, Ostertagia ostertagi (including inhibited larvae), O. lyrata, 
Trichostrongylus axei, T. colubriformis, Cooperia oncophora, C. 
punctata, C. pectinata, Oesophagostomum radiatum, Nematodirus 
helvetianus (adults only), N. spathiger (adults only), Bunostomum 
phlebotomum; lungworms (adults and fourth-stage larvae) (Dictyocaulus 
viviparus); liver flukes (adults only) (Fasciola hepatica); grubs 
(parasitic stages) (Hypoderma bovis, H. lineatum); lice (Linognathus 
vituli, Haematopinus eurysternus, Solenopotes capillatus); mites 
(Psoroptes ovis (syn. P. communis var. bovis), Sarcoptes scabiei var. 
bovis); and for control of infections of D. viviparus and O. radiatum 
for 28 days afer treatment; O. ostertagi, T. axei, and C. punctata for 
21 days after treatment; and H. placei and C. oncophora for 14 days 
after treatment.
    (3) Limitations. (i) Nos. 000010, 055529, and 061133: Do not treat 
cattle within 21 days of slaughter. No. 058005: Do not treat cattle 
within 49 days of slaughter.
    (ii) Because a withdrawal time in milk has not been established, do 
not use in female dairy cattle of breeding age. A withdrawal period has 
not been established for this product in preruminating calves. Do not 
use in calves to be processed for veal.

[55 FR 38984, Sept. 24, 1990, as amended at 62 FR 14302, Mar. 26, 1997; 
62 FR 63271, Nov. 28, 1997; 64 FR 26671, May 17, 1999; 69 FR 31735, June 
7, 2004; 72 FR 27734, May 17, 2007; 77 FR 64717, Oct. 23, 2012; 79 FR 
64116, Oct. 28, 2014; 84 FR 39184, Aug. 9, 2019; 86 FR 14820, Mar. 19, 
2021]

    Editorial Note: At 81 FR 22524, Apr. 18, 2016, Sec. 522.1193 was 
amended; however, the amendment could not be incorporated due to 
inaccurate amendatory instruction.



Sec. 522.1204  Kanamycin.

    (a) Specifications. Each milliliter of solution contains 50 or 200 
milligrams (mg) of kanamycin as kanamycin sulfate.
    (b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in dogs and cats--(1) Amount. Administer by 
subcutaneous or intramuscular injection 5 mg per pound of body weight 
per day in equally divided doses at 12-hour intervals.
    (2) Indications for use. For the treatment of bacterial infections 
due to kanamycin sensitive organisms in dogs and cats.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[79 FR 16190, Mar. 25, 2014]



Sec. 522.1222  Ketamine.

    (a) Specifications. Each milliliter contains ketamine hydrochloride 
equivalent to 100 milligrams (mg) ketamine base activity.
    (b) Sponsors. See Nos. 017033, 054771, 058198, 059399, 063286, and 
069043 in Sec. 510.600(c) of this chapter.
    (c) Special considerations. Federal law restricts this drug to use 
by or on the order of a licensed veterinarian.
    (d) Conditions of use--(1) Cats--(i) Amount. 5 to 15 mg/pound body 
weight intramuscularly, depending on the effect desired.

[[Page 310]]

    (ii) Indications for use. For restraint or as the sole anesthetic 
agent in diagnostic or minor, brief surgical procedures that do not 
require skeletal muscle relaxation.
    (2) Subhuman primates--(i) Amount. 3 to 15 mg/kilogram body weight 
intramuscularly, depending upon the species, general condition, and age 
of the subject.
    (ii) Indications for use. For restraint.

[67 FR 17283, Apr. 10, 2002, as amended at 73 FR 8192, Feb. 13, 2008. 
Redesignated at 79 FR 16191, Mar. 25, 2014, as amended at 80 FR 13229, 
Mar. 13, 2015; 83 FR 48946, Sept. 28, 2018; 86 FR 14820, Mar. 19, 2021]



Sec. 522.1223  Ketamine, promazine, and aminopentamide.

    (a) Specifications. Each milliliter of solution contains ketamine 
hydrochloride equivalent to 100 milligrams (mg) ketamine base activity, 
7.5 (mg) of promazine hydrochloride, and 0.0625 mg of aminopentamide 
hydrogen sulfate.
    (b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in cats--(1) Amount. Administer by 
intramuscular injection 15 to 20 mg ketamine base per pound of body 
weight, depending on the effect desired.
    (2) Indications for use. It is used in cats as the sole anesthetic 
agent for ovariohysterectomy and general surgery.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[79 FR 16191, Mar. 25, 2014]



Sec. 522.1225  Ketoprofen.

    (a) Specifications. Each milliliter of solution contains 100 
milligrams (mg) of ketoprofen.
    (b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in horses--(1) Amount. Administer by 
intravenous injection 1.0 mg per pound of body weight once daily for up 
to 5 days.
    (2) Indications for use. For alleviation of inflammation and pain 
associated with musculoskeletal disorders in horses.
    (3) Limitations. Do not use in horses intended for human 
consumption. Federal law restricts this drug to use by or on the order 
of a licensed veterinarian.

[79 FR 16191, Mar. 25, 2014]



Sec. 522.1242  Levamisole.

    (a) Specifications. Each milliliter of solution contains levamisole 
phosphate equivalent to 136.5 or 182 milligrams of levamisole 
hydrochloride (13.65 or 18.2 percent).
    (b) Sponsor. See Nos. 000061 and 016592 in Sec. 510.600 of this 
chapter for use of 13.65 percent injection, and see No. 054771 for use 
of 13.65 and 18.2 percent injection.
    (c) Related tolerances. See Sec. 556.350 of this chapter.
    (d) Conditions of use--(1) Amount. 2 milliliters per 100 pounds of 
body weight, subcutaneously in the neck.
    (2) Indications for use. (i) The 13.65 percent injection is used as 
an anthelmintic in cattle for treatment of the following parasites: 
stomach worms (Haemonchus, Trichostrongylus, Ostertagia), intestinal 
worms (Trichostrongylus, Cooperia, Nematodirus, Bunostomum, 
Oesophagostomum, Chabertia), and lungworms (Dictyocaulus).
    (ii) The 18.2 percent injection is used as an anthelmintic in cattle 
for treatment of the following parasites: stomach worms (Haemonchus, 
Trichostrongylus, Ostertagia), intestinal worms (Trichostrongylus, 
Cooperia, Nematodirus, Bunostomum, Oesophagostomum) and lungworms 
(Dictyocaulus).
    (3) Limitations. Do not administer more than 10 milliliters per 
site. Cattle that are severely parasitized or maintained under 
conditions of constant helminth exposure may require re-treatment within 
2 to 4 weeks after first treatment. Consult your veterinarian for 
assistance in the diagnosis, treatment, and control of parasitism. 
Consult your veterinarian before using in severely debilitated animals 
or animals under severe stress. Do not administer to cattle within 7 
days of

[[Page 311]]

slaughter. Do not administer to dairy animals of breeding age.

[43 FR 20489, May 12, 1978, as amended at 43 FR 29289, July 7, 1978; 43 
FR 60895, Dec. 29, 1978; 47 FR 10807, Mar. 12, 1982; 62 FR 61625, Nov. 
19, 1997; 65 FR 61090, Oct. 16, 2000; 67 FR 63055, Oct. 10, 2002. 
Redesignated and amended at 79 FR 16191, Mar. 25, 2014; 83 FR 48946, 
Sept. 28, 2018; 84 FR 32992, July 11, 2019]



Sec. 522.1260  Lincomycin.

    (a) Specifications. Each milliliter of solution contains lincomycin 
hydrochloride monohydrate equivalent to:
    (1) 25, 50, 100, or 300 milligrams (mg) lincomycin.
    (2) 25, 100, or 300 mg lincomycin.
    (3) 300 mg lincomycin.
    (4) 100 or 300 mg lincomycin.
    (b) Sponsors. See sponsors in Sec. 510.600(c) of this chapter for 
uses as in paragraph (e) of this section.
    (1) No. 054771 for use of concentrations in paragraph (a)(1) of this 
section as in paragraph (e) of this section.
    (2) Nos. 016592 and 058005 for use of concentrations in paragraph 
(a)(2) of this section as in paragraph (e)(2) of this section.
    (3) No. 054771 for use of concentration in paragraph (a)(3) of this 
section as in paragraph (e)(2) of this section.
    (4) No. 061133 for use of concentrations in paragraph (a)(4) of this 
section as in paragraph (e)(2) of this section.
    (c) Special considerations. When common labeling for use of the drug 
in dogs, cats, and swine is included with the drug, all such uses are 
subject to the labeling requirements of Sec. 201.105 of this chapter.
    (d) Related tolerances. See Sec. 556.360 of this chapter.
    (e) Conditions of use. It is used for animals as follows:
    (1) Dogs and cats--(i) Amount. 5 mg per pound (/lb) of body weight 
twice daily or 10 mg/lb body weight once daily by intramuscular 
injection; 5 to 10 mg/lb body weight one or two times daily by slow 
intravenous injection.
    (ii) Indications for use. Infections caused by Gram-positive 
organisms, particularly streptococci and staphylococci.
    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.
    (2) Swine--(i) Amount. 5 mg/lb body weight once daily by 
intramuscular injection for 3 to 7 days.
    (ii) Indications for use. Treatment of infectious arthritis and 
mycoplasma pneumonia.
    (iii) Limitations. Do not treat within 48 hours of slaughter.

[40 FR 13858, Mar. 27, 1975, as amended at 50 FR 31351, Aug. 2, 1985; 67 
FR 34388, May 14, 2002; 68 FR 51705, Aug. 28, 2003; 69 FR 11507, Mar. 
11, 2004; 69 FR 47361, Aug. 5, 2004; 71 FR 51996, Sept. 1, 2006; 78 FR 
17597, Mar. 22, 2013; 79 FR 16191, Mar. 25, 2014; 81 FR 59134, Aug. 29, 
2016; 84 FR 8974, Mar. 13, 2019]



Sec. 522.1289  Lufenuron.

    (a) Specifications. Each milliliter of suspension contains 100 
milligrams (mg) of lufenuron.
    (b) Sponsor. See No. 058198 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in cats--(1) Amount. 10 mg per kilogram (4.5 
mg per pound) of body weight every 6 months, by subcutaneous injection.
    (2) Indications for use. For control of flea populations in cats 6 
weeks of age and older.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[79 FR 16191, Mar. 25, 2014, as amended at 80 FR 61297, Oct. 13, 2015]



Sec. 522.1290  Luprostiol.

    (a) Specifications. Each milliliter of solution contains 7.5 
milligrams (mg) luprostiol.
    (b) Sponsor. See No. 051311 in Sec. 510.600(c) of this chapter.
    (c) Special considerations. Labeling shall bear the following 
statements: Warning: Women of childbearing age, asthmatics, and persons 
with bronchial and other respiratory problems should exercise extreme 
caution when handling this product. In the early stages, women may be 
unaware of their pregnancies. Luprostiol is readily absorbed through the 
skin and can cause abortion and/or bronchiospasms. Direct contact with 
the skin should therefore be avoided. Accidental spillage on the skin 
should be washed off immediately with soap and water.
    (d) Conditions of use in horses--(1) Amount. 7.5 mg by intramuscular 
injection.

[[Page 312]]

    (2) Indications for use. For estrus control and termination of 
pregnancy in mares.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian. Do not use in horses intended for 
human consumption.

[55 FR 1185, Jan. 12, 1990, as amended at 56 FR 50653, Oct. 8, 1991; 60 
FR 55659, Nov. 2, 1995; 61 FR 66582, Dec. 18, 1996; 74 FR 25146, May 27, 
2009]



Sec. 522.1315  Maropitant.

    (a) Specifications. Each milliliter of solution contains 10 
milligrams (mg) maropitant as maropitant citrate.
    (b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use--(1) Dogs--(i) Amount. Administer 1.0 mg per 
kilogram (mg/kg) of body weight by subcutaneous or intravenous injection 
once daily for up to 5 consecutive days.
    (ii) Indications for use. For the prevention and treatment of acute 
vomiting.
    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.
    (2) Cats--(i) Amount. Administer 1.0 mg/kg of body weight by 
subcutaneous or intravenous injection once daily for up to 5 consecutive 
days.
    (ii) Indications for use. For the treatment of vomiting.
    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

[72 FR 9243, Mar. 1, 2007, as amended at 77 FR 39391, July 3, 2012; 79 
FR 16191, Mar. 25, 2014; 81 FR 22524, Apr. 18, 2016]



Sec. 522.1335  Medetomidine.

    (a) Specifications. Each milliliter of solution contains 1.0 
milligrams of medetomidine hydrochloride.
    (b) Sponsor. See Nos. 015914 and 052483 in Sec. 510.600(c) of this 
chapter.
    (c) Conditions of use--(1) Amount. 750 micrograms intravenously (IV) 
or 1,000 micrograms intramuscularly per square meter of body surface. 
The IV route is more efficacious for dental care.
    (2) Indications for use. As a sedative and analgesic in dogs over 12 
weeks of age to facilitate clinical examinations, clinical procedures, 
minor surgical procedures not requiring muscle relaxation, and minor 
dental procedures not requiring intubation. The intravenous route of 
administration is more efficacious for dental care.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[61 FR 21075, May 9, 1996, as amended at 79 FR 16191, Mar. 25, 2014; 82 
FR 58556, Dec. 13, 2017]



Sec. 522.1350  Melatonin implant.

    (a) Specifications. The drug is a silicone rubber elastomer implant 
containing 2.7 milligrams of melatonin.
    (b) Sponsor. See No. 053923 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use--(1) Amount. One implant per mink.
    (2) Indications for use. For use in healthy male and female kit and 
adult female mink (Mustela vison) to accelerate the fur priming cycle.
    (3) Limitations. For subcutaneous implantation in mink only. Do not 
implant potential breeding stock. Do not use in food-producing animals.

[59 FR 37422, July 22, 1994]



Sec. 522.1362  Melarsomine powder for injection.

    (a) Specifications. The drug consists of a vial of lyophilized 
powder containing 50 milligrams of melarsomine dihydrochloride which is 
reconstituted with the provided 2 milliliters of sterile water for 
injection.
    (b) Sponsor. See Nos. 000010 and 086073 in Sec. 510.600(c) of this 
chapter.
    (c) Conditions of use--(1) Amount. Administer only by deep 
intramuscular injection in the lumbar muscles (L3-
L5).
    (2) Indications. Treatment of stabilized, class 1, 2, and 3 
heartworm disease (asymptomatic to mild, moderate, and severe, 
respectively) caused by immature (4 month-old, stage L5) to 
mature adult infections of Dirofilaria immitis in dogs.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[60 FR 49340, Sept. 25, 1995, as amended at 79 FR 16191, Mar. 25, 2014; 
82 FR 21690, May 10, 2017; 84 FR 39184, Aug. 9, 2019]

[[Page 313]]



Sec. 522.1367  Meloxicam.

    (a) Specifications. Each milliliter of solution contains 5.0 
milligrams (mg) meloxicam.
    (b) Sponsors. See Nos. 000010, 016729, 026637, and 055529 in Sec. 
510.600(c) of this chapter.
    (c) Conditions of use--(1) Dogs--(i) Amount. Administer 0.09 mg per 
pound (mg/lb) body weight (0.2 mg per kilogram (mg/kg)) by intravenous 
or subcutaneous injection on the first day of treatment. For treatment 
after day 1, administer meloxicam suspension orally at 0.045 mg/lb (0.1 
mg/kg) body weight once daily as in Sec. 520.1367(c) of this chapter.
    (ii) Indications for use. For the control of pain and inflammation 
associated with osteoarthritis.
    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.
    (2) Cats--(i) Amount. Administer 0.14 mg/lb (0.3 mg/kg) body weight 
as a single, one-time subcutaneous injection.
    (ii) Indications for use. For the control of postoperative pain and 
inflammation associated with orthopedic surgery, ovariohysterectomy, and 
castration when administered prior to surgery.
    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

[68 FR 68724, Dec. 10, 2003, as amended at 69 FR 69523, Nov. 30, 2004; 
78 FR 5715, Jan. 28, 2013; 79 FR 74020, Dec. 15, 2014; 85 FR 18119, Apr. 
1, 2020]



Sec. 522.1372  Mepivacaine.

    (a) Specifications. Each milliliter (mL) of solution contains 20 
milligrams mepivacaine hydrochloride.
    (b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in horses--(1) Amount. For nerve block, 3 to 5 
mL; for epidural anesthesia, 5 to 20 mL; for intra-articular anesthesia, 
10 to 15 mL; for infiltration, as required; for anesthesia of the 
laryngeal mucosa prior to ventriculectomy, by topical spray, 25 to 40 
mL, by infiltration, 20 to 50 mL.
    (2) Indications for use. For use as a local anesthetic for 
infiltration, nerve block, intra-articular and epidural anesthesia, and 
topical and/or infiltration anesthesia of the laryngeal mucosa prior to 
ventriculectomy.
    (3) Limitations. Not for use in horses intended for human 
consumption. Federal law restricts this drug to use by or on the order 
of a licensed veterinarian.

[71 FR 39547, July 13, 2006, as amended at 79 FR 16191, Mar. 25, 2014]



Sec. 522.1380  Methocarbamol.

    (a) Specifications. Each milliliter of solution contains 100 
milligrams (mg) of methocarbamol.
    (b) Sponsor. See No. 051031 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use--(1) Amount--(i) Dogs and cats. Administer by 
intravenous injection 20 mg per pound of body weight for moderate 
conditions or 25 to 100 mg per pound of body weight for severe 
conditions (tetanus and strychnine poisoning). The total cumulative dose 
should not to exceed 150 mg per pound of body weight.
    (ii) Horses. Administer by intravenous injection 2 to 10 mg per 
pound of body weight for moderate conditions or 10 to 25 mg per pound of 
body weight for severe conditions (tetanus). Additional amounts may be 
needed to relieve residual effects and to prevent recurrence of 
symptoms.
    (2) Indications for use. As an adjunct for treating acute 
inflammatory and traumatic conditions of the skeletal muscles and to 
reduce muscular spasms.
    (3) Limitations. Do not use in horses intended for human 
consumption. Federal law restricts this drug to use by or on the order 
of a licensed veterinarian.

[79 FR 16191, Mar. 25, 2014, as amended at 82 FR 11508, Feb. 24, 2017]



Sec. 522.1410  Methylprednisolone.

    (a) Specifications. Each milliliter of suspension contains 20 or 40 
milligrams (mg) of methylprednisolone acetate.
    (b) Sponsors. See Nos. 054771 and 069043 in Sec. 510.600(c) of this 
chapter.
    (c) [Reserved]
    (d) Conditions of use--(1) Dogs--(i) Amount. Administer 2 to 40 mg 
(up to 120 mg in extremely large breeds or dogs with severe involvement) 
by intramuscular injection or up to 20 mg by intrasynovial injection.

[[Page 314]]

    (ii) Indications for use. For treatment of inflammation and related 
disorders; treatment of allergic and dermatologic disorders; and as 
supportive therapy to antibacterial treatment of severe infections.
    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.
    (2) Cats--(i) Amount. Administer 10 to 20 mg by intramuscular 
injection.
    (ii) Indications for use. For treatment of inflammation and related 
disorders; treatment of allergic and dermatologic disorders; and as 
supportive therapy to antibacterial treatment of severe infections.
    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.
    (3) Horses--(i) Amount. Administer 200 mg by intramuscular injection 
or 40 to 240 mg by intrasynovial injection.
    (ii) Indications for use. For treatment of inflammation and related 
disorders.
    (iii) Limitations. Do not use in horses intended for human 
consumption. Federal law restricts this drug to use by or on the order 
of a licensed veterinarian.

[43 FR 59058, Dec. 19, 1978, as amended at 51 FR 741, Jan. 8, 1986; 53 
FR 40728, Oct. 18, 1988; 62 FR 35076, June 30, 1997; 76 FR 53051, Aug. 
25, 2011; 78 FR 21060, Apr. 9, 2013; 79 FR 16191, Mar. 25, 2014; 83 FR 
48946, Sept. 28, 2018]



Sec. 522.1450  Moxidectin solution.

    (a) Specifications. Each milliliter of solution contains 10 
milligrams (mg) moxidectin.
    (b) Sponsor. See No. 058198 in Sec. 510.600(c) of this chapter.
    (c) Related tolerances. See Sec. 556.426 of this chapter.
    (d) Special considerations. See Sec. 500.25 of this chapter.
    (e) Conditions of use in beef and nonlactating dairy cattle--(1) 
Amount. Administer 0.2 mg/kg of body weight (0.2 mg/2.2 pound) as a 
single, subcutaneous injection.
    (2) Indications for use. For treatment and control of 
gastrointestinal roundworms: Ostertagia ostertagi (adults, fourth-stage 
larvae, and inhibited larvae), Haemonchus placei (adults), 
Trichostrongylus axei (adults and fourth-stage larvae), Trichostrongylus 
colubriformis (adults and fourth-stage larvae), Cooperia oncophora 
(adults), Cooperia pectinata (adults), Cooperia punctata (adults and 
fourth-stage larvae), Cooperia spatulata (adults), Cooperia surnabada 
(adults and fourth-stage larvae), Nematodirus helvetianus (adults), 
Oesophagostomum radiatum (adults and fourth-stage larvae), Trichuris 
spp. (adults); lungworms: Dictyocaulus viviparus (adults and fourth-
stage larvae); grubs: Hypoderma bovis and Hypoderma lineatum; mites: 
Psoroptes ovis (Psoroptes communis var. bovis); lice: Linognathus vituli 
and Solenopotes capillatus; for protection of cattle from reinfection 
with D. viviparus and O. radiatum for 42 days after treatment, with H. 
placei for 35 days after treatment, and with O. ostertagi and T. axei 
for 14 days after treatment.
    (3) Limitations. Do not slaughter cattle within 21 days of 
treatment. Because a withholding time for milk has not been established, 
do not use in female dairy cattle 20 months of age and older. A 
withdrawal period has not been established for pre-ruminating calves. Do 
not use in calves to be processed for veal.

[70 FR 36337, June 23, 2005, as amended at 71 FR 7414, Feb. 13, 2006; 76 
FR 48714, Aug. 9, 2011; 82 FR 21690, May 10, 2017; 86 FR 14820, Mar. 19, 
2021]



Sec. 522.1451  Moxidectin microspheres for injection.

    (a) Specifications. The drug product consists of two separate vials. 
One vial contains 10 percent moxidectin microspheres and the second vial 
contains a vehicle for constitution of the moxidectin microspheres.
    (1) Each milliliter (mL) of constituted suspension contains 3.4 
milligrams (mg) moxidectin.
    (2) Each mL of constituted suspension contains 10 mg moxidectin.
    (b) Sponsor. See No. 54771 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in dogs--(1) Amount. (i) Using the suspension 
described in paragraph (a)(1) of this section, administer 0.05 mL of the 
constituted suspension per kilogram (kg) of body weight (0.023 mL per 
pound (lb)) as a single subcutaneous injection to provide 0.17 mg/kg 
body weight (0.0773 mg/lb).

[[Page 315]]

    (ii) Using the suspension described in paragraph (a)(2) of this 
section, administer 0.05 mL of the constituted suspension/kg of body 
weight (0.023 mL/lb) as a single subcutaneous injection to provide 0.5 
mg/kg body weight (0.23 mg/lb).
    (2) Indications for use--(i) Suspension described in paragraph 
(a)(1) of this section. For prevention of heartworm disease caused by 
Dirofilaria immitis in dogs 6 months of age and older; and for treatment 
of existing larval and adult hookworm (Ancylostoma caninum and Uncinaria 
stenocephala) infections.
    (ii) Suspension described in paragraph (a)(2) of this section. For 
prevention of heartworm disease caused by Dirofilaria immitis for 12 
months in dogs 12 months of age and older; and for treatment of existing 
larval and adult hookworm (Ancylostoma caninum and Uncinaria 
stenocephala) infections.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[85 FR 4208, Jan. 24, 2020]



Sec. 522.1452  Nalorphine.

    (a) Specifications. Each milliliter of solution contains 5 
milligrams of nalorphine hydrochloride.
    (b) Sponsor. See No. 000010 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in dogs--(1) Amount. One milligram per 5 
pounds; intravenously, intramuscularly, or subcutaneously.
    (2) Indications for use. Respiratory and circulatory depression in 
dogs resulting from overdosage of, or unusual sensitivity to, morphine 
and certain other narcotics. Not for depression due to any other cause.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[44 FR 6707, Feb. 2, 1979, as amended at 47 FR 36418, Aug. 20, 1982; 62 
FR 63271, Nov. 28, 1997; 79 FR 16191, Mar. 25, 2014; 84 FR 39184, Aug. 
9, 2019]



Sec. 522.1465  Naltrexone.

    (a) Specifications. Each milliliter of solution contains 50 
milligrams of naltrexone hydrochloride.
    (b) Sponsor. See 053923 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in elk and moose--(1) Amount. 100 milligrams 
of naltrexone hydrochloride for each milligram of carfentanil citrate 
administered. One-quarter of the dose should be administered 
intravenously and three-quarters of the dose should be administered 
subcutaneously.
    (2) Indications for use. As an antagonist to carfentanil citrate 
immobilization in free-ranging or confined elk and moose (Cervidae).
    (3) Limitations. Do not use in domestic food-producing animals. Do 
not use in free-ranging animals for 45 days before or during hunting 
season. Federal law restricts this drug to use by or on the order of a 
licensed veterinarian.

[62 FR 5320, Feb. 5, 1997, as amended at 79 FR 16191, Mar. 25, 2014]



Sec. 522.1468  Naproxen for injection.

    (a) Specifications. The drug is a lyophilized powder which is 
reconstituted with sterile water for injection to form a 10 percent 
sterile aqueous solution (100 milligrams per milliliter).
    (b) Sponsor. See 054771 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in horses--(1) Dosage. Five milligrams per 
kilogram of body weight intravenously followed by maintenance oral 
therapy of 10 milligrams per kilogram of body weight twice daily for up 
to 14 consecutive days.
    (2) Indications for use. For the relief of inflammation and 
associated pain and lameness exhibited with arthritis, as well as 
myositis and other soft tissue diseases of the musculoskeletal system of 
the horse.
    (3) Limitations. Not for use in horses intended for food. Federal 
law restricts this drug to use by or on the order of a licensed 
veterinarian.

[46 FR 26763, May 15, 1981. Redesignated and amended at 51 FR 24525, 
July 7, 1986; 61 FR 5507, Feb. 13, 1996; 79 FR 16192, Mar. 25, 2014]



Sec. 522.1484  Neomycin.

    (a) Specifications. Each milliliter of solution contains 50 
milligrams (mg) of neomycin sulfate (equivalent to 35 mg of neomycin 
base).
    (b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in dogs and cats--(1) Amount. Administer 5 mg 
per pound of body weight daily by intramuscular or intravenous 
injection, divided into

[[Page 316]]

portions administered every 6 to 8 hours for 3 to 5 days.
    (2) Indications for use. For the treatment of acute and chronic 
bacterial infections due to organisms susceptible to neomycin.
    (3) Limitations. Not for parenteral use in food-producing animals 
because of prolonged residues in edible tissues. Federal law restricts 
this drug to use by or on the order of a licensed veterinarian.

[79 FR 16192, Mar. 25, 2014]



Sec. 522.1503  Neostigmine.

    (a) Specifications. Each milliliter of solution contains 2 
milligrams (mg) neostigmine methylsulfate.
    (b) Sponsor. See No. 000061 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use--(1) Amount. Administer to cattle and horses 
at a dosage level of 1 mg per (/) 100 pounds (lbs) of body weight 
subcutaneously. Administer to sheep at a dosage level of 1 to 1\1/2\ mg/
100 lbs body weight subcutaneously. Administer to swine at a dosage 
level of 2 to 3 mg/100 lbs body weight intramuscularly. These doses may 
be repeated as indicated.
    (2) Indications for use. For treating rumen atony; initiating 
peristalsis which causes evacuation of the bowel; emptying the urinary 
bladder; and stimulating skeletal muscle contractions.
    (3) Limitations. Not for use in animals producing milk, since this 
use will result in contamination of the milk. Federal law restricts this 
drug to use by or on the order of a licensed veterinarian.

[40 FR 13858, Mar. 27, 1975, as amended at 62 FR 61625, Nov. 19, 1997; 
79 FR 16192, Mar. 25, 2014]



Sec. 522.1610  Oleate sodium.

    (a) Specifications. Each milliliter of solution contains 50 
milligrams (mg) of sodium oleate.
    (b) Sponsor. See No. 037990 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in horses--(1) Amount. Administer by 
parenteral injection depending on the area of response desired. An 
injection of 1 milliliter (mL) will produce a response of approximately 
15 square centimeters. Do not inject more than 2 mL per injection site. 
Regardless of the number of injection sites, the total volume used 
should not exceed 10 mL.
    (2) Indications for use. It is used in horses to stimulate 
infiltration of cellular blood components that subsequently 
differentiate into fibrous and/or fibrocartilagenous tissue.
    (3) Limitations. Do not use in horses intended for human 
consumption. Federal law restricts this drug to use by or on the order 
of a licensed veterinarian.

[41 FR 27034, July 1, 1976, as amended at 50 FR 40966, Oct. 8, 1985; 79 
FR 16192, Mar. 25, 2014]



Sec. 522.1660  Oxytetracycline injectable dosage forms.



Sec. 522.1660a  Oxytetracycline solution, 200 milligrams/milliliter.

    (a) Specifications. Each milliliter of sterile solution contains 200 
milligrams of oxytetracycline base.
    (b) Sponsors. See Nos. 000010, 016592, 048164, 054771, 055529, and 
061133 in Sec. 510.600(c) of this chapter.
    (c) Related tolerances. See Sec. 556.500 of this chapter.
    (d) Special considerations. When labeled for the treatment of 
anaplasmosis or anthrax, labeling shall also bear the following: 
``Federal law restricts this drug to use by or on the order of a 
licensed veterinarian.''
    (e) Conditions of use--(1) Beef cattle, dairy cattle, and calves 
including prerumenative (veal) calves--(i) Amounts and indications for 
use. (A) 3 to 5 mg per pound of body weight (mg/lb BW) per day (/day) 
intramuscularly, subcutaneously, or intravenously for treatment of 
pneumonia and shipping fever complex associated with Pasteurella spp. 
and Haemophilus spp., foot-rot and diphtheria caused by Fusobacterium 
necrophorum, bacterial enteritis (scours) caused by Escherichia coli, 
wooden tongue caused by Actinobacillus lignieresii, leptospirosis caused 
by Leptospira pomona, wound infections and acute metritis caused by 
Staphylococcus spp. and Streptococcus spp., and anthrax caused by 
Bacillus anthracis.
    (B) 5 mg/lb BW/day intramuscularly or intravenously for treatment of 
anaplasmosis caused by Anaplasma

[[Page 317]]

marginale, severe foot-rot, and advanced cases of other indicated 
diseases.
    (C) 9 mg/lb BW intramuscularly or subcutaneously as single dosage 
where retreatment of calves and yearlings for bacterial pneumonia is 
impractical, for treatment of infectious bovine keratoconjunctivitis 
(pinkeye) caused by Moraxella bovis, or where retreatment for 
anaplasmosis is impractical.
    (ii) Limitations. Exceeding the highest recommended level of drug 
per pound of bodyweight per day, administering more than the recommended 
number of treatments, and/or exceeding 10 mL intramuscularly or 
subcutaneously per injection site in adult beef and dairy cattle may 
result in antibiotic residues beyond the withdrawal time. Rapid 
intravenous administration in cattle may result in animal collapse. 
Oxytetracycline should be administered intravenously slowly over a 
period of at least 5 minutes. Discontinue treatment at least 28 days 
prior to slaughter. Milk taken from animals during treatment and for 96 
hours after the last treatment must not be used for food.
    (2) Swine--(i) Amounts and indications for use. (A) Sows: 3 mg/lb BW 
intramuscularly once, approximately 8 hours before farrowing or 
immediately after completion of farrowing, as an aid in control of 
infectious enteritis (baby pig scours, colibacillosis) in suckling pigs 
caused by E. coli.
    (B) 3 to 5 mg/lb BW/day intramuscularly for treatment of bacterial 
enteritis (scours, colibacillosis) caused by E. coli, pneumonia caused 
by Pasteurella multocida, and leptospirosis caused by Leptospira pomona.
    (C) 9 mg/lb BW as a single dosage where retreatment for pneumonia is 
impractical.
    (ii) Limitations. Administer intramuscularly. Do not inject more 
than 5 mL per site in adult swine. Discontinue treatment at least 28 
days prior to slaughter.

[45 FR 16479, Mar. 14, 1980. Redesignated and amended at 69 FR 31879, 
June 8, 2004]

    Editorial Note: For Federal Register citations affecting Sec. 
522.1660a, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and at www.govinfo.gov.



Sec. 522.1660b  Oxytetracycline solution, 300 milligrams/milliliter.

    (a) Specifications. Each milliliter (mL) of solution contains 300 
milligrams (mg) oxytetracycline base.
    (b) Sponsor. See No. 055529 in Sec. 510.600(c) of this chapter.
    (c) Related tolerances. See Sec. 556.500 of this chapter.
    (d) Special considerations. When labeled for use as in paragraph 
(e)(1)(i)(D) or (e)(1)(i)(E) of this section, labeling shall also bear 
the following: ``Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.''.
    (e) Conditions of use--(1) Beef cattle, nonlactating dairy cattle, 
and calves including preruminating (veal) calves--(i) Amounts and 
indications for use. (A) 3 to 5 mg per pound of bodyweight (mg/lb BW) 
per day (/day) intramuscularly, subcutaneously, or intravenously for 
treatment of pneumonia and shipping fever complex associated with 
Pasteurella spp. and Histophilus spp., foot-rot and diphtheria caused by 
Fusobacterium necrophorum, bacterial enteritis (scours) caused by 
Escherichia coli, wooden tongue caused by Actinobacillus lignieresii, 
leptospirosis caused by Leptospira pomona, wound infections and acute 
metritis caused by Staphylococcus spp. and Streptococcus spp.
    (B) 5 mg/lb BW/day intramuscularly, subcutaneously, or intravenously 
for treatment of severe foot-rot, and advanced cases of other indicated 
diseases.
    (C) 9 mg/lb BW intramuscularly or subcutaneously as single dosage 
where retreatment of calves and yearlings for bacterial pneumonia is 
impractical or for treatment of infectious bovine keratoconjunctivitis 
(pinkeye) caused by Moraxella bovis.
    (D) 9 to 13.6 mg/lb BW intramuscularly or subcutaneously as single 
dosage where retreatment of calves and yearlings for bacterial pneumonia 
is impractical or for treatment of infectious bovine 
keratoconjunctivitis (pinkeye) caused by Moraxella bovis.
    (E) 13.6 mg/lb BW intramuscularly or subcutaneously as a single 
dosage for control of respiratory disease in cattle

[[Page 318]]

at high risk of developing BRD associated with Mannheimia (Pasteurella) 
haemolytica.
    (ii) Limitations. Treatment should be continued 24 to 48 hours 
following remission of disease signs, however, not to exceed a total of 
four consecutive days. Do not inject more than 10 mL per site in adult 
cattle, reducing the volume according to age and body size to 1 to 2 mL 
in small calves. Exceeding the highest recommended level of drug/lb BW/
day, administering more than the recommended number of treatments, and/
or exceeding 10 mL intramuscularly or subcutaneously per injection site 
may result in antibiotic residues beyond the withdrawal time. Rapid 
intravenous administration may result in animal collapse. 
Oxytetracycline should be administered intravenously slowly over a 
period of at least 5 minutes. Discontinue treatment at least 28 days 
prior to slaughter. Not for use in lactating dairy animals.
    (2) Swine--(i) Amounts and indications for use. (A) Sows: 3 mg/lb BW 
intramuscularly once, approximately 8 hours before farrowing or 
immediately after completion of farrowing, as an aid in control of 
infectious enteritis (baby pig scours, colibacillosis) in suckling pigs 
caused by E. coli.
    (B) 3 to 5 mg/lb BW/day intramuscularly for treatment of bacterial 
enteritis (scours, colibacillosis) caused by E. coli, pneumonia caused 
by Pasteurella multocida, and leptospirosis caused by Leptospira pomona.
    (C) 9 mg/lb BW as a single dosage where retreatment for pneumonia is 
impractical.
    (ii) Limitations. Administer intramuscularly. Treatment should be 
continued 24 to 48 hours beyond remission of disease signs, however, not 
to exceed a total of 4 consecutive days. Exceeding the highest 
recommended level of drug/lb BW/day, administering more than the 
recommended number of treatments, and/or exceeding 5 mL intramuscularly 
per injection site may result in antibiotic residues beyond the 
withdrawal time. Discontinue treatment at least 28 days prior to 
slaughter.

[68 FR 54805, Sept. 19, 2003. Redesignated and amended at 69 FR 31879, 
June 8, 2004; 73 FR 14926, Mar. 20, 2008]



Sec. 522.1662  Oxytetracycline hydrochloride implantation
or injectable dosage forms.



Sec. 522.1662a  Oxytetracycline hydrochloride injection.

    (a) For related tolerances see Sec. 556.500 of this chapter.
    (b)(1) Specifications. The drug contains 50 milligrams of 
oxytetracycline hydrochloride in each milliliter of sterile solution.
    (2) Sponsor. See No. 069043 in Sec. 510.600(c) of this chapter.
    (3) Conditions of use. (i) The drug is intended for use in beef 
cattle, beef calves, nonlactating dairy cattle, and dairy calves for 
treatment of disease conditions caused by one or more of the following 
oxytetracycline sensitive pathogens listed as follows: pneumonia and 
shipping fever complex (Pasteurella spp.; Hemophilis spp.; Klebsiella 
spp. ), bacterial enteritis (scours) (E. coli), foot-rot (Spherophorus 
necrophorus), diphtheria (Spherophorus necrophorus), wooden tongue 
(Actinobacillus lignieresi), leptospirosis (Leptospira pomona), and 
wound infections; acute metritis; traumatic injury (caused by a variety 
of bacterial organisms (such as streptococcal and staphylococcal 
organisms).)
    (ii) It is administered by intramuscular injection of 3 to 5 
milligrams of oxytetracycline hydrochloride per pound of body weight per 
day. Leptospirosis, severe foot-rot and severe forms of the indicated 
diseases should be treated with 5 milligrams per pound of body weight 
per day. Treatment should be continued for 24 to 48 hours following 
remission of disease symptoms; however, not to exceed a total of 4 
consecutive days. Only 2 milliliters of the drug should be injected per 
site in case of calves weighing 100 pounds or less and not more than 10 
milliliters should be injected per site in adult cattle.
    (iii) Discontinue treatment with the drug at least 20 days prior to 
slaughter of the animal. When administered to animals within 30 days of 
slaughter, muscle discoloration may necessitate trimming of injection 
site and surrounding tissues.

[[Page 319]]

    (iv) For use only in beef cattle, beef calves, nonlactating dairy 
cattle, and dairy calves.
    (c)(1) Specifications. Each milliliter of sterile solution contains 
50 or 100 milligrams of oxytetracycline (as oxytetracycline 
hydrochloride).
    (2) Sponsor. See 069043 in Sec. 510.600(c) of this chapter.
    (3) Conditions of use--(i) Beef cattle and nonlactating dairy 
cattle--(A) Amount. Three to 5 milligrams of oxytetracycline per pound 
of body weight per day; 5 milligrams per pound of body weight per day 
for the treatment of anaplasmosis, severe foot-rot, and severe cases of 
other indicated diseases.
    (B) Indications for use. Treatment of diseases due to 
oxytetracycline-susceptible organisms as follows: Pneumonia and shipping 
fever complex associated with Pasteurella spp., Haemophilus spp., and 
Klebsiella spp., foot-rot and diphtheria caused by Spherophorus 
necrophorus, bacterial enteritis (scours) caused by Escherichia coli, 
wooden tongue caused by Actinobacillus lignieresi, leptospirosis caused 
by Leptospira pomona, and wound infections and acute metritis caused by 
Staphylococcus spp. and Streptococcus spp. If labeled for use by or on 
the order of a licensed veterinarian, it may be used for the treatment 
of anaplasmosis caused by Anaplasma marginale.
    (C) Limitations. For 50-milligram-per-milliliter solution, 
administer intramuscularly or intravenously; for 100-milligram-per-
milliliter solution, administer intramuscularly only. Treatment of all 
diseases should be instituted early and continue for 24 to 48 hours 
beyond remission of disease symptoms, but not to exceed a total of 4 
consecutive days. Consult your veterinarian if no improvement is noted 
within 48 hours. Do not inject more than 10 milliliters per site in 
adult cattle, reducing the volume according to age and body size to 0.5 
to 2 milliliters in small calves. Exceeding the highest recommended dose 
of 5 milligrams per pound of body weight, administering at recommended 
levels for more than 4 consecutive days, and/or exceeding 10 milliliters 
intramuscularly per injection site may result in antibiotic residues 
beyond the withdrawal time. Discontinue treatment at least 18 days prior 
to slaughter. Not for use in lactating dairy cattle.
    (ii) Swine--(A) Amount. Three to 5 milligrams of oxytetracycline per 
pound of body weight per day. Sows: 3 milligrams of oxytetracycline per 
pound of body weight, approximately 8 hours before farrowing or 
immediately after completion of farrowing.
    (B) Indications for use. For treatment of bacterial enteritis 
(scours, colibacillosis) caused by Escherichia coli, pneumonia caused by 
Pasteurella multocida, and leptospirosis caused by Leptospira pomona. 
Sows: as an aid in control of infectious enteritis (baby pig scours, 
colibacillosis) in suckling pigs caused by Escherichia coli.
    (C) Limitations. Administer intramuscularly. Do not inject more than 
5 milliliters per site. Do not use for more than 4 consecutive days. 
Discontinue treatment at least 26 days before slaughter.
    (d)(1) Specifications. The drug contains 50 or 100 milligrams of 
oxytetracycline hydrochloride in each milliliter of sterile solution.
    (2) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
    (3) Conditions of use. (i) The drug is intended for use in the 
treatment of disease due to oxytetracycline-susceptible organisms in 
beef cattle and non-lactating dairy cattle. It is indicated in the 
treatment of pneumonia and shipping fever complex associated with 
Pasteurella spp., Haemophilus spp., Klebsiella spp., foot-rot and 
diphtheria caused by Spherophorus necrophorus, bacterial enteritis 
(scours) caused by Escherichia coli, wooden tongue caused by 
Actinobacillus lignieresi, acute metritis, and wound infections caused 
by staphylococcal and streptococcal organisms.
    (ii) It is administered to cattle at a dosage level of 3 to 5 
milligrams per pound of body weight per day. It may be administered 
intramuscularly or intravenously from a 50 milligram per milliliter 
solution. It is administered intravenously from a 100 milligram per 
milliliter solution. Severe foot-rot and the severe forms of the 
indicated diseases should be treated with 5 milligrams per pound of body 
weight. Treatment should be continued 24 to 48

[[Page 320]]

hours following remission of disease symptoms, however, not to exceed a 
total of 4 consecutive days. If no improvement is noted within 24 hours, 
consult a veterinarian. When injecting the drug intramuscularly, do not 
inject more than 10 milliliters per site in adult cattle. Reduce the 
amount injected at each site according to the size of the animal. For 
very small calves do not use more than 2 milliliters per injection site.
    (iii) Not for use in lactating dairy cattle. Discontinue treatment 
at least 19 days prior to slaughter. When administered intramuscularly 
within 30 days of slaughter, muscle discoloration may necessitate 
trimming of the injection site and surrounding tissues.
    (e)(1) Specifications. The drug contains 50 milligrams of 
oxytetracycline hydrochloride in each milliliter of sterile solution.
    (2) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
    (3) Conditions of use. (i) In beef cattle and nonlactating dairy 
cattle as follows:
    (A) It is used for the treatment of pneumonia and shipping fever 
complex associated with Pasteurella spp. and Haemophilus spp.; foot-rot 
and diphtheria caused by Spherophorus necrophorus; bacterial enteritis 
(scours) caused by Escherichia coli; wooden tongue caused by 
Actinobacillus lignieresi; leptospirosis caused by Leptospira pomona; 
wound infections and acute metritis caused by staphylococcal and 
streptococcal organisms.
    (B) Administer by intravenous or intramuscular injection at 3 to 5 
milligrams of oxytetracycline per pound of body weight per day. In the 
treatment of severe foot-rot and severe forms of the indicated diseases, 
a dosage level of 5 milligrams per pound of body weight per day is 
recommended.
    (C) If the labeling of the drug bears the statement ``Federal law 
restricts this drug to use by or on the order of a licensed 
veterinarian,'' it may include additional directions for use in beef 
cattle and nonlactating dairy cattle for the treatment of anaplasmosis 
caused by Anaplasma marginale, and anthrax caused by Bacillus anthracis 
in which case the drug is given at 3 to 5 milligrams of oxytetracycline 
per pound of body weight per day for anthrax, and at 5 milligrams per 
pound of body weight per day for anaplasmosis.
    (ii) In swine as follows:
    (A) It is used for the treatment of bacterial enteritis (scours, 
colibacillosis) caused by Escherichia coli; pneumonia caused by 
Pasteurella multocida; and leptospirosis caused by Leptospira pomona. 
Administered to sows as an aid in the control of infectious enteritis 
(baby pig scours, colibacillosis) in suckling pigs caused by Escherichia 
coli.
    (B) Administer by intramuscular injection at 3 to 5 milligrams of 
oxytetracycline per pound of body weight per day to swine. Administered 
to sows at 3 milligrams of oxytetracycline per pound of body weight 
approximately 8 hours before farrowing or immediately after farrowing.
    (iii) In poultry (broilers, turkeys, and breeding chickens) as 
follows:
    (A) It is used for the treatment of air sacculitis (air-sac disease, 
chronic respiratory disease) caused by Mycoplasma gallisepticum and 
Escherichia coli; fowl cholera caused by Pasteurella multocida; 
infectious sinusitis caused by Mycoplasma gallisepticum; and infectious 
synovitis caused by Mycoplasma synoviae.
    (B) Administered subcutaneously to chickens 1 day to 2 weeks of age 
at 6.25 milligrams of oxytetracycline per bird per day diluted with 1 
part of the drug to 3 parts of sterile water; to chickens 2 to 4 weeks 
of age using the same diluted product at 12.5 milligrams of 
oxytetracycline per bird; to chickens 4 to 8 weeks of age without 
dilution at 25 milligrams of oxytetracycline per bird; to chickens 8 
weeks of age (broilers and light pullets) at 50 milligrams of 
oxytetracycline per bird; to adult chickens at 100 milligrams of 
oxytetracycline per bird.
    (C) Administered subcutaneously to turkeys 1 day to 2 weeks of age 
and 2 to 4 weeks of age at the same dosage as chickens; to turkeys 4 to 
6 weeks of age at 50 milligrams of oxytetracycline as the undiluted 
product per bird; to turkeys 6 to 9 weeks of age at 100 milligrams of 
oxytetracycline per bird; to turkeys 9 to 12 weeks of age at 150 
milligrams of oxytetracycline per bird; to turkeys 12 weeks of age and 
older at 200 milligrams of oxytetracycline per bird.

[[Page 321]]

In light turkey breeds, no more than 25 milligrams per pound of body 
weight is administered. For the treatment of infectious sinusitis in 
turkeys, \1/4\ to \1/2\ milliliter of the drug is injected directly into 
each swollen sinus depending upon the age of the bird and the severity 
of the condition. At the time that the sinuses are treated, the drug 
should also be administered subcutaneously to the birds according to the 
dosage schedule given in this paragraph (e)(3)(iii)(C). If refilling of 
the sinuses occurs, the treatment may be repeated in 5 to 7 days.
    (iv) Treatment of all diseases should be instituted early. Treatment 
should continue for 24 to 48 hours beyond the remission of disease 
symptoms, but not exceed a total of 4 consecutive days. If no 
improvement is noted within 24 to 48 hours, diagnosis and therapy should 
be reevaluated.
    (v) When injecting intramuscularly in adult livestock, do not inject 
more than 10 milliliters at any one site. The volume administered per 
injection site should be reduced according to age and body size so that 
1 or 2 milliliters are injected in smaller animals such as small calves 
and young pigs. Intravenous administration is recommended in cattle when 
daily dosage exceeds 50 milliliters.
    (vi) Treatment must be discontinued at least 5 days prior to 
slaughter for chickens and turkeys and at least 22 days prior to 
slaughter for cattle and swine. When administered intramuscularly to 
animals within 30 days of slaughter, muscle discoloration may 
necessitate trimming of the injection site(s) and surrounding tissues 
during the dressing procedure.
    (vii) Not for use in lactating dairy animals. Do not administer to 
laying hens unless the eggs are used for hatching only.
    (f)(1) Specifications. Each milliliter of solution contains 100 
milligrams of oxytetracycline hydrochloride.
    (2) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
    (3) Conditions of use--(i) Beef cattle and nonlactating dairy 
cattle--(A) Amount. 3 to 5 milligrams of oxytetracycline per pound of 
body weight per day; 5 milligrams per pound of body weight per day for 
treatment of anaplasmosis, severe foot-rot, and severe cases of other 
indicated diseases.
    (B) Indications for use. Treatment of diseases due to 
oxytetracycline-susceptible organisms as follows: Pneumonia and shipping 
fever complex associated with Pasteurella spp. and Haemophilus spp., 
foot-rot and diphtheria caused by Fusobacterium necrophorum, bacterial 
enteritis (scours) caused by Escherichia coli, wooden tongue caused by 
Actinobacillus lignieresii, leptospirosis caused by Leptospira pomona, 
and wound infections and acute metritis caused by Staphylococcus spp. 
and Streptococcus spp. If labeled for use by or on the order of a 
licensed veterinarian, it may be used for the treatment of anaplasmosis 
caused by Anaplasma marginale and anthrax caused by Bacillus anthracis.
    (C) Limitations. Administer intramuscularly. Treatment of all 
diseases should be instituted early and continue for 24 to 48 hours 
beyond remission of disease symptoms, but not to exceed a total of 4 
consecutive days. Consult your veterinarian if no improvement is noted 
within 48 hours. Do not inject more than 10 milliliters per site in 
adult cattle, reducing the volume according to age and body size to 1 to 
2 milliliters in small calves. Exceeding the highest recommended dose of 
5 milligrams per pound of body weight per day, administering more than 
the recommended number of treatments, and/or exceeding 10 milliliters 
intramuscularly or subcutaneously per injection site in adult beef and 
dairy cattle may result in antibiotic residues beyond the withdrawal 
period. Discontinue treatment at least 15 days prior to slaughter. Not 
for use in lactating dairy cattle.
    (ii) Swine--(A) Amount. 3 to 5 milligrams of oxytetracycline per 
pound of body weight per day. Sows: 3 milligrams of oxytetracycline per 
pound of body weight, administered once, approximately 8 hours before 
farrowing or immediately after completion of farrowing.
    (B) Indications for use. For treatment of bacterial enteritis 
(scours, colibacillosis) caused by Escherichia coli, pneumonia caused by 
Pasteurella multocida, and leptospirosis caused by Leptospira pomona. 
Sows: as an aid in

[[Page 322]]

control of infections enteritis (baby pig scours, colibacillosis) in 
suckling pigs caused by Escherichia coli.
    (C) Limitations. Administer intramuscularly. Do not inject more than 
5 milliliters per site in adult swine, reducing the volume according to 
age and body size to 1 to 2 milliliters in young pigs. Discontinue 
treatment at least 22 days prior to slaughter.
    (g)(1) Specifications. Each milliliter of sterile solution contains 
100 milligrams of oxytetracycline as oxytetracycline hydrochloride.
    (2) Sponsor. See No. 069043 in Sec. 510.600(c) of this chapter.
    (3) Conditions of use. The drug is used for the treatment of 
diseases due to oxytetracycline-susceptible organisms as follows:
    (i) Beef cattle, beef calves, nonlactating dairy cattle, and dairy 
calves--(A) Amount. 3 to 5 milligrams of oxytetracycline per pound of 
body weight per day.
    (B) Indications for use. For the treatment of pneumonia and shipping 
fever complex associated with Pasteurella spp., Haemophilus spp., or 
Klebsiella spp.
    (C) Limitations. Administer by intramuscular, intravenous, or 
subcutaneous injection. In severe forms of the indicated diseases, 
administer 5 milligrams of oxytetracycline per pound of body weight per 
day. Continue treatment 24 to 48 hours following remission of disease 
symptoms, not to exceed a total of 4 consecutive days. If no improvement 
is noted within 48 hours, consult a veterinarian. Do not inject more 
than 10 milliliters per injection site intramuscularly in adult cattle; 
no more than 1 milliliter per site in calves weighing 100 pounds or 
less. Do not slaughter cattle for 13 days after intramuscular or 
intravenous treatment, or 2 days after subcutaneous treatment. Exceeding 
the highest recommended dosage or duration of treatment (not more than 4 
consecutive days) may result in residues beyond the withdrawal period. A 
withdrawal period has not been established for use of this product in 
preruminating calves. Do not use in calves to be processed for veal.
    (ii) Swine--(A) Amount. 3 to 5 milligrams of oxytetracycline per 
pound of body weight per day. Sows: Administer once 3 milligrams of 
oxytetracycline per pound of body weight, approximately 8 hours before 
farrowing or immediately after completion of farrowing.
    (B) Indications for use. For treatment of bacterial enteritis 
(scours, colibacillosis) caused by Escherichia coli, pneumonia caused by 
Pasteurella multocida, and leptospirosis caused by Leptospira pomona. 
Sows: As an aid in control of infectious enteritis (baby pig scours, 
colibacillosis) in suckling pigs caused by Escherichia coli.
    (C) Limitations. Administer intramuscularly. If no improvement is 
noted within 24 hours, consult a veterinarian. Do not inject more than 5 
milliliters per site. Discontinue treatment at least 20 days prior to 
slaughter.
    (h)(1) Specifications. Each milliliter of sterile solution contains 
50 or 100 milligrams of oxytetracycline hydrochloride.
    (2) Sponsors. See No. 069043 in Sec. 510.600(c) of this chapter for 
use of 50 and 100 milligrams per milliliter solution; and Nos. 016592 
and 055529 in Sec. 510.600(c) for use of 100 milligrams per milliliter 
solution.
    (3) Conditions of use--(i) Amount. The drug is used in beef cattle, 
beef calves, nonlactating dairy cattle, and dairy calves as follows: 3 
to 5 milligrams of oxytetracycline hydrochloride per pound of body 
weight per day; 5 milligrams per pound of body weight per day for 
treatment of severe forms of the indicated diseases.
    (ii) Indications for use. The drug is used for treatment of 
bacterial pneumonia and shipping fever complex associated with 
Pasteurella spp.; foot-rot and calf diphtheria caused by Fusobacterium 
necrophorum bacterial enterities (scours) caused by Escherichia coli; 
wooden tongue caused by Actinobacillus lignieresi; wound infections, 
acute metrities, and traumatic injury caused by staphylococcal and 
streptococcal organisms.
    (iii) Limitations. Administer 50-milligram-per-milliliter solution 
intramuscularly; administer 100-milligram-per-milliliter solution 
intravenously. Continue treatment 24 to 48 hours following remission of 
disease symptoms, not to exceed a total of 4 consecutive days. If no 
improvement is

[[Page 323]]

noted within 24 to 48 hours, consult a veterinarian for diagnosis and 
therapy. When injecting the drug intramuscularly, do no inject more than 
10 milliliters per site in adult cattle. Reduce the volume administered 
per injection site according to age and body size. In calves weighing 
100 pounds or less, do no inject more than 2 milliliters intramuscularly 
per site. Discontinue treatment at least 22 days before slaughter. Not 
for use in lactating dairy animals. A withdrawal period has not been 
established for this product in preruminating calves. Do not use in 
calves to be processed for veal.
    (i)(1) Specifications. Each milliliter of sterile solution contains 
50 milligrams of oxytetracycline hydrochloride.
    (2) Sponsor. See No. 016592 in Sec. 510.600(c) of this chapter.
    (3) Conditions of use--(i) Amount. The drug is used in beef cattle, 
beef calves, nonlactating dairy cattle, and dairy calves as follows: 
Administer 3 to 5 milligrams of the oxytetracycline hydrochloride 
intramuscularly per pound of body weight per day.
    (ii) Indications for use. The drug is used for treatment of 
bacterial pneumonia and shipping fever complex associated with 
Pasteurella spp.; foot-rot and diptheria caused by Spherophorus 
necrophorus; bacterial enteritis (scours) caused by Escherichia coli; 
wooden tongue caused by Actinobacillus lignieresi; wound infections and 
acute metritis caused by staphylococcal and streptococcal organisms 
susceptible to oxytetracycline.
    (iii) Limitations. In severe forms of the indicated diseases, 
administer the equivalent of 5 milligrams of oxytetracycline 
hydrochloride per pound of body weight per day. Continue treatment 24 to 
48 hours following remission of disease symptoms, not to exceed a total 
of 4 consecutive days. If no improvement is noted within 24 to 48 hours, 
consult a veterinarian for diagnosis and therapy. In adult livestock, do 
not inject more than 10 milliliters at any one site. Reduce the volume 
administered per injection site according to age and body size. In 
calves weighing 100 pounds or less inject only 2 milliliters per site. 
Discontinue treatment at least 18 days before slaughter. Not for use in 
lactating dairy cattle.
    (j)(1) Specifications. Each milliliter of sterile solution contains 
either 50 or 100 milligrams of oxytetracycline hydrochloride.
    (2) Sponsor. See No. 061133 in Sec. 510.600(c) of this chapter.
    (3) Conditions of use in beef cattle and nonlactating dairy cattle--
(i) Amount. 3 to 5 milligrams per pound of body weight daily, 5 
milligrams per pound for anaplasmosis, severe foot rot, and severe forms 
of other diseases.
    (ii) Indications for use. Treatment of diseases due to 
oxytetracycline-susceptible organisms as follows: pneumonia and shipping 
fever complex associated with Pasteurella spp. and Haemophilus spp.; 
foot rot and diphtheria caused by Fusobacterium necrophorum; bacterial 
enteritis (scours) caused by Escherichia coli; wooden tongue caused by 
Actinobacillus lignieresii; leptospirosis caused by Leptospira pomona; 
acute metritis and wound infections caused by staphylococcal and 
streptococcal organisms; if labeled for use by or on the order of a 
licensed veterinarian, it may be used for treatment of anaplasmosis 
caused by Anaplasma marginale and anthrax caused by Bacillus anthracis.
    (iii) Limitations. Administer by intravenous injection. Treatment 
should be continued 24 to 48 hours following remission of disease 
symptoms, but not to exceed a total of 4 consecutive days. If no 
improvement occurs within 24 to 48 hours, reevaluate diagnosis and 
therapy. Discontinue use at least 19 days prior to slaughter. Not for 
use in lactating dairy cattle.

[40 FR 13858, Mar. 27, 1975]

    Editorial Note: For Federal Register citations affecting Sec. 
522.1662a, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and at www.govinfo.gov.



Sec. 522.1662b  Oxytetracycline hydrochloride with lidocaine 
injection.

    (a) Specifications. The drug contains 50 or 100 milligrams of 
oxytetracycline hydrochloride and 2 percent lidocaine in each milliliter 
of sterile aqueous solution.
    (b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.

[[Page 324]]

    (c) Conditions of use. (1) The drug is indicated for use in the 
treatment of diseases of dogs caused by pathogens sensitive to 
oxytetracycline hydrochloride including treatment for the following 
conditions in dogs caused by susceptible microorganisms: Bacterial 
infections of the urinary tract caused by Hemolytic staphylococcus, 
Streptococcus spp., Bacterial pulmonary infections caused by Brucella 
bronchiseptica, Streptococcus pyogenes, Staphylococcus aureus, secondary 
bacterial infections caused by Micrococcus pyogenes var. albus, Brucella 
bronchiseptica, Streptococcus spp.
    (2) The drug is administered intramuscularly at a recommended daily 
dosage to dogs at 5 milligrams per pound of body weight administered in 
divided doses at 6 to 12 hour intervals. Therapy should be continued for 
at least 24 hours after all symptoms have subsided.
    (3) Federal law restricts this drug to use by or on the order of a 
licensed veterinarian.

[40 FR 13858, Mar. 27, 1975, as amended at 48 FR 30615, July 5, 1983; 79 
FR 16192, Mar. 25, 2014]



Sec. 522.1664  Oxytetracycline and flunixin.

    (a) Specifications. Each milliliter (mL) of solution contains 300 
milligrams (mg) oxytetracycline base as amphoteric oxytetracycline and 
20 mg flunixin base as flunixin meglumine.
    (b) Sponsor. See No. 055529 in Sec. 510.600(c) of this chapter.
    (c) Related tolerances. See Sec. Sec. 556.286 and 556.500 of this 
chapter.
    (d) Conditions of use cattle--(1) Amount. Administer once as an 
intramuscular or subcutaneous injection of 1 mL per 22 pounds (lb) body 
weight (BW) (13.6 mg oxytetracycline and 0.9 mg flunixin per lb BW) 
where retreatment of calves and yearlings for bacterial pneumonia is 
impractical due to husbandry conditions, such as cattle on range, or 
where their repeated restraint is inadvisable.
    (2) Indications for use. For the treatment of bacterial pneumonia 
associated with Pasteurella spp. and for the control of associated 
pyrexia in beef and nonlactating dairy cattle.
    (3) Limitations. Discontinue treatment at least 21 days prior to 
slaughter of cattle. This drug product is not approved for use in female 
dairy cattle 20 months of age or older, including dry dairy cows. Use in 
these cattle may cause drug residues in milk and/or in calves born to 
these cows. A withdrawal period has not been established in 
preruminating calves. Do not use in calves to be processed for veal. 
Federal law restricts this drug to use by or on the order of a licensed 
veterinarian.

[76 FR 3489, Jan. 20, 2011, as amended at 79 FR 16192, Mar. 25, 2014]



Sec. 522.1680  Oxytocin.

    (a) Specifications. Each milliliter (mL) of solution contains 20 USP 
units oxytocin.
    (b) Sponsors. See Nos. 054771 and 061133 in Sec. 510.600(c) of this 
chapter.
    (c) Conditions of use--(1) Amount--(i) Obstetrical. Administer drug 
intravenously, intramuscularly, or subcutaneously under aseptic 
conditions as indicated. The following dosages are recommended and may 
be repeated as conditions require:

------------------------------------------------------------------------
                                          mL             U.S.P. units
------------------------------------------------------------------------
Cats............................  0.25 to 0.5.......  5 to 10.
Dogs............................  0.25 to 1.5.......  5 to 30.
Ewes, Sows......................  1.5 to 2.5........  30 to 50.
Cows, Horses....................  5.0...............  100.
------------------------------------------------------------------------

    (ii) Milk letdown. Intravenous administration is desirable. The 
following dosage is recommended and may be repeated as conditions 
require:

------------------------------------------------------------------------
                                          mL             U.S.P. units
------------------------------------------------------------------------
Cows............................  0.5 to 1.0........  10 to 20.
Sows............................  0.25 to 1.0.......  5 to 20.
------------------------------------------------------------------------

    (2) Indications for use. Oxytocin may be used as a uterine 
contractor to precipitate and accelerate normal parturition and 
postpartum evacuation of uterine debris. In surgery it may be used 
postoperatively following cesarean section to facilitate involution and 
resistance to the large inflow of blood. It will contract smooth muscle 
cells of the mammary gland for milk letdown if the udder is in proper 
physiological state.

[[Page 325]]

    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[44 FR 63097, Nov. 2, 1979; 45 FR 1019, Jan. 4, 1980]

    Editorial Note: For Federal Register citations affecting Sec. 
522.1680, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and at www.govinfo.gov.



Sec. 522.1684  Pegbovigrastim.

    (a) Specifications. Each pre-filled, single-dose syringe contains 15 
milligrams of pegbovigrastim.
    (b) Sponsor. See No. 058198 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in cattle--(1) Amount. Administer the first 
dose (syringe) by subcutaneous injection 7 days prior to the cow's or 
heifer's anticipated calving date. If necessary, the first dose may be 
administered within a range of 4 to 10 days prior to the anticipated 
calving date to accommodate management schedules. Administer the second 
dose (syringe) by subcutaneous injection within 24 hours after calving.
    (2) Indications for use. For the reduction in the incidence of 
clinical mastitis in the first 30 days of lactation in periparturient 
dairy cows and periparturient replacement dairy heifers.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[81 FR 36789, June 8, 2016, as amended at 81 FR 48702, July 26, 2016]



Sec. 522.1696  Penicillin G procaine injectable dosage forms.



Sec. 522.1696a  Penicillin G benzathine and penicillin G procaine
suspension.

    (a) Specifications. Each milliliter of aqueous suspension contains 
penicillin G benzathine and penicillin G procaine, each equivalent to 
150,000 units of penicillin G.
    (b) Sponsors. See sponsors in Sec. 510.600(c) of this chapter for 
the conditions of use in paragraph (d) of this section as follows:
    (1) Nos. 054771 and 061133 for use as in paragraph (d)(1) of this 
section.
    (2) Nos. 016592 and 061133 for use as in paragraphs (d)(2)(i), 
(d)(2)(ii)(A), and (d)(2)(iii) of this section.
    (3) No. 054771 for use as in paragraphs (d)(2)(i), (d)(2)(ii)(B), 
and (d)(2)(iii) of this section.
    (c) Related tolerances. See Sec. 556.510 of this chapter.
    (d) Conditions of use--(1) Horses, dogs, and beef cattle--(i) 
Amount--(A) Beef cattle. 2 milliliters per 150 pounds of body weight 
intramuscularly or subcutaneously. Repeat dosage in 48 hours.
    (B) Horses. 2 milliliters per 150 pounds of body weight 
intramuscularly. Repeat dosage in 48 hours.
    (C) Dogs. 1 milliliter per 10 to 25 pounds of body weight 
intramuscularly or subcutaneously. Repeat dosage in 48 hours.
    (ii) Indications for use. Treatment of bacterial infections 
susceptible to penicillin G.
    (iii) Limitations. Not for use in beef cattle within 30 days of 
slaughter. Do not use in horses intended for human consumption. Federal 
law restricts this drug to use by or on the order of a licensed 
veterinarian.
    (2) Beef cattle--(i) Amount. 2 milliliters per 150 pounds of body 
weight subcutaneously. Repeat dosage in 48 hours.
    (ii) Indications for use. (A) Treatment of bacterial pneumonia 
(Streptococcus spp., Actinomyces pyogenes, Staphylococcus aureus); upper 
respiratory infections such as rhinitis or pharyngitis (A. pyogenes); 
blackleg (Clostridium chauvoei).
    (B) As in paragraph (d)(2)(ii)(A) of this section; and prophylaxis 
of bovine shipping fever in 300- to 500-pound beef calves.
    (iii) Limitations. Not for use within 30 days of slaughter. For Nos. 
000859 and 016592: A withdrawal period has not been established for this 
product in pre-ruminating calves. Do not use in calves to be processed 
for veal.

[66 FR 711, Jan. 4, 2001, as amended at 68 FR 34534, June 10, 2003; 70 
FR 21947, Apr. 28, 2005; 70 FR 50182, Aug. 26, 2005; 73 FR 16754, Mar. 
31, 2008; 75 FR 54017, Sept. 3, 2010; 77 FR 4897, Feb. 1, 2012; 78 FR 
17597, Mar. 22, 2013; 79 FR 16192, Mar. 25, 2014; 81 FR 22524, Apr. 18, 
2016; 84 FR 8974, Mar. 13, 2019; 85 FR 18120, Apr. 1, 2020; 86 FR 14820, 
Mar. 19, 2021]

[[Page 326]]



Sec. 522.1696b  Penicillin G procaine aqueous suspension.

    (a) Specifications. Each milliliter contains penicillin G procaine 
equivalent to 300,000 units of penicillin G.
    (b) Sponsors. See sponsor numbers in Sec. 510.600(c) of this 
chapter as follows:
    (1) Nos. 016592 and 054771 for use as in paragraph (d) of this 
section.
    (2) No. 061133 for use as in paragraph (d)(2) of this section.
    (c) Related tolerances. See Sec. 556.510 of this chapter.
    (d) Conditions of use--(1) Dogs and cats--(i) Amount. 10,000 units 
per pound body weight daily by intramuscular injection at 24-hour 
intervals. Continue treatment at least 48 hours after symptoms 
disappear.
    (ii) Indications for use. Treatment of infections caused by 
penicillin-sensitive organisms.
    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.
    (2) Cattle, sheep, swine, and horses--(i) Amount. 3,000 units per 
pound body weight (1 milliliter per 100 pounds body weight) daily by 
intramuscular injection.
    (ii) Indications for use. Treatment of cattle and sheep for 
bacterial pneumonia (shipping fever) caused by Pasteurella multocida; 
swine for erysipelas caused by Erysipelothrix rhusiopathiae; and horses 
for strangles caused by Streptococcus equi.
    (iii) Limitations. Not for use in horses intended for food. Milk 
that has been taken during treatment and for 48 hours after the last 
treatment must not be used for food.
    (A) For Nos. 054771 and 061133: Do not exceed 7 days of treatment in 
nonlactating dairy and beef cattle, sheep, and swine, or 5 days in 
lactating cattle. Discontinue treatment for the following number of days 
before slaughter: Nonruminating cattle (calves)--7; all other cattle--4; 
sheep--8; and swine--6.
    (B) For No. 016592: Continue treatment at least 1 day after symptoms 
disappear (usually 2 or 3 days).

[66 FR 712, Jan. 4, 2001, as amended at 68 FR 34534, June 10, 2003; 68 
FR 42589, July 18, 2003; 69 FR 17586, Apr. 5, 2004; 70 FR 16935, Apr. 4, 
2005; 73 FR 14177, Mar. 17, 2008; 75 FR 54017, Sept. 3, 2010; 78 FR 
17597, Mar. 22, 2013; 79 FR 16192, Mar. 25, 2014; 81 FR 22524, Apr. 18, 
2016; 84 FR 8974, Mar. 13, 2019; 85 FR 18120, Apr. 1, 2020]



Sec. 522.1696c  Penicillin G procaine in oil.

    (a) Specifications. Each milliliter contains penicillin G procaine 
equivalent to 300,000 units of penicillin G.
    (b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use--(1) Amount. Dogs and cats--10,000 units per 
pound of body weight once daily. Horses--3,000 units per pound of body 
weight once daily.
    (2) Indications for use. Treatment of infections of dogs, cats, and 
horses caused by penicillin-susceptible organisms such as Streptococci, 
Staphylococci, and Corynebacteria.
    (3) Limitations. Not for use in food-producing animals. Federal law 
restricts this drug to use by or on the order of a licensed 
veterinarian.

[57 FR 37333, Aug. 18, 1992, as amended at 79 FR 16193, Mar. 25, 2014]



Sec. 522.1697  Pentobarbital and phenytoin.

    (a) Specifications. Each milliliter (mL) of solution contains 390 
milligrams (mg) pentobarbital sodium and 50 mg phenytoin sodium.
    (b) Sponsors. See Nos. 000061, 051311, 054925, and 059399 in Sec. 
510.600(c) of this chapter.
    (c) Special considerations. Product labeling shall bear the 
following warning statements: ``ENVIRONMENTAL HAZARD: This product is 
toxic to wildlife. Birds and mammals feeding on treated animals may be 
killed. Euthanized animals must be properly disposed of by deep burial, 
incineration, or other method in compliance with State and local laws, 
to prevent consumption of carcass material by scavenging wildlife.''
    (d) Conditions of use in dogs--(1) Amount. Administer 1 mL per 10 
pounds

[[Page 327]]

of body weight as a single, bolus intravenous or intracardiac injection.
    (2) Indications for use. For humane, painless, and rapid euthanasia.
    (3) Limitations. Do not use in animals intended for food. Federal 
law restricts this drug to use by or on the order of a licensed 
veterinarian.

[85 FR 18120, Apr. 1, 2020, as amended at 85 FR 45308, July 28, 2020]



Sec. 522.1698  Pentazocine.

    (a) Specifications. Each milliliter of solution contains pentazocine 
lactate equivalent to 30 milligrams (mg) of pentazocine base.
    (b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use--(1) Horses--(i) Amount. Administer 0.15 mg 
pentazocine base per pound of body weight daily by intravenous or 
intramuscular injection. In cases of severe pain, a second dose is 
recommended by intramuscular injection 10 to 15 minutes after the 
initial dose at the same level.
    (ii) Indications for use. For symptomatic relief of pain due to 
colic.
    (iii) Limitations. Do not use in horses intended for human 
consumption. Federal law restricts this drug to use by or on the order 
of a licensed veterinarian.
    (2) Dogs--(i) Amount. Administer 0.75 to 1.50 mg of pentazocine base 
per pound of body weight by intramuscular injection.
    (ii) Indications for use. For amelioration of pain accompanying 
postoperative recovery, fracture, trauma, and spinal disorders.
    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

[42 FR 31450, June 21, 1977, as amended at 42 FR 36995, July 19, 1977; 
47 FR 5409, Feb. 5, 1982; 55 FR 23076, June 6, 1990; 79 FR 16193, Mar. 
25, 2014]



Sec. 522.1704  Pentobarbital.

    (a) Specifications. Each milliliter of solution contains 64.8 
milligrams (mg) of sodium pentobarbital.
    (b) Sponsor. See No. 000061 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use--(1) Amount. The drug is administered 
intravenously ``to effect''. For general surgical anesthesia, the usual 
dose is 11 to 13 mg per pound of body weight. For sedation, the usual 
dose is approximately 2 mg per pound of body weight. For relieving 
convulsive seizures caused by strychnine in dogs, the injection should 
be administered intravenously ``to effect''. The drug may be 
administered intraperitoneally. When given intraperitoneally, it is 
administered at the same dosage level as for intravenous administration.
    (2) Indications for use. The drug is indicated for use as a general 
anesthetic in dogs and cats. Although it may be used as a general 
surgical anesthetic for horses, it is usually given at a lower dose to 
cause sedation and hypnosis and may be supplemented with a local 
anesthetic. It may also be used in dogs for the symptomatic treatment of 
strychnine poisoning.
    (3) Limitations. Do not use in horses intended for human 
consumption. Federal law restricts this drug to use by or on the order 
of a licensed veterinarian.

[79 FR 16193, Mar. 25, 2014]



Sec. 522.1720  Phenylbutazone.

    (a) Specifications. (1) Each milliliter of solution contains 100 
milligrams (mg) of phenylbutazone.
    (2) Each milliliter of solution contains 200 mg of phenylbutazone.
    (b) Sponsors. See sponsor numbers in Sec. 510.600(c) of this 
chapter for use as in paragraph (c) of this section:
    (1) No. 054771 for use of product described in paragraph (a)(1) as 
in paragraph (c) of this section.
    (2) Nos. 000061, 054771, 058198, and 061133 for use of product 
described in paragraph (a)(2) of this section as in paragraph (c) of 
this section.
    (3) Nos. 058005 and 069043 for use of product described in paragraph 
(a)(2) as in paragraph (c)(2) of this section.
    (c) Conditions of use--(1) Dogs--(i) Amount. Administer by 
intravenous injection 10 mg per pound of body weight daily in three 
divided doses, not to exceed 800 mg daily regardless of weight. Limit 
intravenous administration to 2 successive days. Oral medication may 
follow.
    (ii) Indications for use. It is used for the relief of inflammatory 
conditions associated with the musculoskeletal system.

[[Page 328]]

    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.
    (2) Horses--(i) Amount. Administer by intravenous injection 1 to 2 
grams (g) per 1,000 pounds of body weight daily in three divided doses, 
not to exceed 4 g daily. Limit intravenous administration to not more 
than 5 successive days.
    (ii) Indications for use. For the relief of inflammatory conditions 
associated with the musculoskeletal system.
    (iii) Limitations. Do not use in horses intended for human 
consumption. Federal law restricts this drug to use by or on the order 
of a licensed veterinarian.

[79 FR 16193, Mar. 25, 2014, as amended at 83 FR 48946, Sept. 28, 2018; 
84 FR 8974, Mar. 13, 2019; 86 FR 14820, Mar. 19, 2021]



Sec. 522.1820  Pituitary luteinizing hormone powder for injection.

    (a) Specifications. The drug is a lyophilized pituitary extract. 
Each 6-milliliter vial contains an amount equivalent to 25 milligrams of 
standard pituitary luteinizing hormone and is reconstituted for use by 
addition of 5 milliliters of 0.9 percent aqueous sodium chloride 
solution.
    (b) Sponsor. No. 000061 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use--(1) Amount. Cattle and horses: 25 milligrams; 
swine: 5 milligrams; sheep: 2.5 milligrams; and dogs: 1.0 milligram. 
Preferably given by intravenous injection, it may be administered 
subcutaneously. Treatment may be repeated in 1 to 4 weeks, or as 
indicated.
    (2) Indications for use. As an aid in the treatment of breeding 
disorders related to pituitary hypofunction in cattle, horses, swine, 
sheep, and dogs.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[40 FR 13858, Mar. 27, 1975, as amended at 52 FR 7832, Mar. 13, 1987; 79 
FR 16193, Mar. 25, 2014]



Sec. 522.1850  Polysulfated glycosaminoglycan.

    (a) Specifications. (1) Each 1-milliliter (mL) ampule of solution 
contains 250 milligrams (mg) polysulfated glycosaminoglycan.
    (2) Each mL of solution packaged in 5-mL ampules or 20-, 30-, or 50-
mL vials contains 100 mg polysulfated glycosaminoglycan.
    (b) Sponsor. See No. 010797 in Sec. 510.600(c) of this chapter.
    (c) Special considerations. Federal law restricts this drug to use 
by or on the order of a licensed veterinarian.
    (d) Conditions of use--(1) Horses--(i) Indications for use. For the 
treatment of noninfectious degenerative and/or traumatic joint 
dysfunction and associated lameness of the carpal and hock joints in 
horses.
    (ii) Amount--(A) Intra-articular use (carpal): 250 mg once a week 
for 5 weeks.
    (B) Intramuscular use (carpal and hock): 500 mg every 4 days for 28 
days.
    (iii) Limitations. Do not use in horses intended for human 
consumption.
    (2) Dogs--(i) Indications for use. For control of signs associated 
with noninfectious degenerative and/or traumatic arthritis of canine 
synovial joints.
    (ii) Amount. 2 mg per pound of body weight by intramuscular 
injection twice weekly for up to 4 weeks (maximum of 8 injections).

[72 FR 56896, Oct. 5, 2007, as amended at 74 FR 67816, Dec. 21, 2009]



Sec. 522.1862  Pralidoxime powder for injection.

    (a) Specifications. Each vial contains 1 gram (g) of pralidoxime 
chloride powder for mixing with 20 cubic centimeters of sterile water 
for injection. Each milliliter of constituted solution contains 50 
milligrams (mg) pralidoxime chloride.
    (b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use--(1) Amount. Administer as soon as possible 
after exposure to the poison. Before administration of the sterile 
pralidoxime chloride, atropine is administered intravenously at a dosage 
rate of 0.05 mg per pound of body weight, followed by administration of 
an additional 0.15 mg of atropine per pound of body weight administered 
intramuscularly. Then the appropriate dosage of sterile pralidoxime 
chloride is administered slowly intravenously. The dosage rate for 
sterile

[[Page 329]]

pralidoxime chloride when administered to horses is 2 g per horse. When 
administered to dogs and cats, it is 25 mg per pound of body weight. For 
small dogs and cats, sterile pralidoxime chloride may be administered 
either intraperitoneally or intramuscularly. A mild degree of 
atropinization should be maintained for at least 48 hours. Following 
severe poisoning, a second dose of sterile pralidoxime chloride may be 
given after 1 hour if muscle weakness has not been relieved.
    (2) Indications for use. It is used in horses, dogs, and cats as an 
antidote in the treatment of poisoning due to those pesticides and 
chemicals of the organophosphate class which have anticholinesterase 
activity in horses, dogs, and cats.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[79 FR 16193, Mar. 25, 2014]



Sec. 522.1870  Praziquantel.

    (a) Specifications. Each milliliter (mL) of solution contains 56.8 
milligrams of praziquantel.
    (b) Sponsors. See Nos. 058198 and 061133 in Sec. 510.600(c) of this 
chapter.
    (c) Conditions of use--(1) Dogs--(i) Amount. Administer by 
subcutaneous or intramuscular injection for dogs and puppies 5 pounds 
(lb) and under, 0.3 mL; for 6 to 10 lb, 0.5 mL; for 11 to 25 lb, 1.0 mL; 
if over 25 lb, 0.2 mL/5 lb body weight to a maximum of 3 mL.
    (ii) Indications for use. For removal of canine cestodes Dipylidium 
caninum, Taenia pisiformis, and Echinococcus granulosus, and removal and 
control of canine cestode Echinococcus multilocularis.
    (iii) Limitations. Federal law restricts the drug to use by or on 
the order of a licensed veterinarian.
    (2) Cats--(i) Amount. Administer by subcutaneous or intramuscular 
injection for cats and kittens under 5 lb, 0.2 mL; 5 to 10 lb, 0.4 mL; 
11 lb and over, 0.6 mL maximum.
    (ii) Indications for use. For removal of feline cestodes Dipylidium 
caninum and Taenia taeniaeformis.
    (iii) Limitations. Federal law restricts the drug to use by or on 
the order of a licensed veterinarian.

[46 FR 10464, Feb. 3, 1981, as amended at 47 FR 6617, Feb. 16, 1982; 58 
FR 42853, Aug. 12, 1993; 67 FR 79853, Dec. 31, 2002; 78 FR 17868, Mar. 
25, 2013; 81 FR 67151, Sept. 30, 2016; 84 FR 8974, Mar. 13, 2019; 86 FR 
14820, Mar. 19, 2021]



Sec. 522.1881  Prednisolone acetate.

    (a) Specifications. Each milliliter of suspension contains 25 
milligrams (mg) of prednisolone acetate.
    (b) Sponsor. See No. 000061 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use--(1) Amount. The drug is administered to 
horses intra-articularly at a dosage level of 50 to 100 mg. The dose may 
be repeated when necessary. The drug is administered to dogs and cats 
intramuscularly at a dosage level of 10 to 50 mg. The dosage may be 
repeated when necessary. If the condition is of a chronic nature, an 
oral corticosteroid may be given as a maintenance dosage. The drug may 
be given intra-articularly to dogs and cats at a dosage level of 5 to 25 
mg. The dose may be repeated when necessary after 7 days for two or 
three doses.
    (2) Indications for use. The drug is indicated in the treatment of 
dogs, cats, and horses for conditions requiring an anti-inflammatory 
agent. The drug is indicated for the treatment of acute musculoskeletal 
inflammations such as bursitis, carpitis, and spondylitis. The drug is 
indicated as supportive therapy in nonspecific dermatosis such as summer 
eczema and atopy. The drug may be used as supportive therapy pre- and 
postoperatively and for various stress conditions when corticosteroids 
are required while the animal is being treated for a specific condition.
    (3) Limitations. Do not use in horses intended for human 
consumption. Federal law restricts this drug to use by or on the order 
of a licensed veterinarian.

[79 FR 16194, Mar. 25, 2014]



Sec. 522.1883  Prednisolone sodium phosphate.

    (a) Specifications. Each milliliter of solution contains 20 
milligrams (mg) prednisolone sodium phosphate (equivalent to 14.88 mg of 
prednisolone).
    (b) Sponsor. See No. 061133 in Sec. 510.600(c) of this chapter.

[[Page 330]]

    (c) Conditions of use in dogs--(1) Amount. Administer intravenously 
in a dosage of 2\1/2\ to 5 mg per pound of body weight, initially for 
shock and shock-like states, followed by equal maintenance doses at 1-, 
3-, 6-, or 10-hour intervals as determined by the condition of the 
animal.
    (2) Indications for use. Administer when a rapid adrenal 
glucocorticoid and/or anti-inflammatory effect is necessary.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[68 FR 59881, Oct. 20, 2003, as amended at 84 FR 8974, Mar. 13, 2019]



Sec. 522.1884  Prednisolone sodium succinate.

    (a) Specifications. Each milliliter of prednisolone sodium succinate 
injection contains: Prednisolone sodium succinate equivalent in activity 
to 10, 20, or 50 milligrams (mg) of prednisolone.
    (b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter for 
products containing 10, 20, and 50 mg equivalent prednisolone activity 
per milliliter for use in horses, dogs, and cats as provided in 
paragraphs (c)(1)(i), (ii), and (iii) of this section.
    (c) Conditions of use--(1) Amount and indications for use--(i) 
Horses. Administer 50 to 100 mg as an initial dose by intravenous 
injection over a period of one-half to 1 minute, or by intramuscular 
injection, and may be repeated in inflammatory, allergic, or other 
stress conditions at intervals of 12, 24, or 48 hours, depending upon 
the size of the animal, the severity of the condition and the response 
to treatment.
    (ii) Dogs. Administer by intravenous injection at a range of 2.5 to 
5 mg per pound of body weight as an initial dose followed by maintenance 
doses at 1, 3, 6, or 10 hour intervals, as determined by the condition 
of the animal, for treatment of shock.
    (iii) Dogs and cats. Administer by intramuscular injection for 
treatment of inflammatory, allergic, and less severe stress conditions, 
where immediate effect is not required, at 1 to 5 mg ranging upward to 
30 to 50 mg in large breeds of dogs. Dosage may be repeated in 12 to 24 
hours and continued for 3 to 5 days if necessary. If permanent 
corticosteroid effect is required, oral therapy with prednisolone 
tablets may be substituted.
    (2) Limitations. Do not use in horses intended for human 
consumption. Federal law restricts this drug to use by or on the order 
of a licensed veterinarian.

[79 FR 16194, Mar. 25, 2014]



Sec. 522.1885  Prednisolone tertiary butylacetate.

    (a) Specifications. Each milliliter of suspension contains 20 
milligrams (mg) of prednisolone tertiary butylacetate.
    (b) Sponsor. See No. 000010 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use--(1) Amount--(i) Horses: Administer by 
intramuscular injection 100 to 300 mg or by intrasynovial injection at a 
dosage level of 50 to 100 mg. Retreatment of horses in 24 to 48 hours 
may be necessary, depending on the general condition of the animal and 
the severity and duration of the disease.
    (ii) Dogs and cats: Administer by intramuscular injection 1 mg per 5 
pounds of body weight or intrasynovially at a dosage level of 10 to 20 
mg.
    (2) Indications for use. It is used as an anti-inflammatory agent in 
horses, dogs, and cats.
    (3) Limitations. Do not use in horses intended for human 
consumption. Federal law restricts this drug to use by or on the order 
of a licensed veterinarian.

[79 FR 16194, Mar. 25, 2014, as amended at 84 FR 39184, Aug. 9, 2019]



Sec. 522.1890  Prednisone suspension.

    (a) Specifications. Each milliliter of suspension contains 10 to 40 
milligrams (mg) of prednisone.
    (b) Sponsor. See No. 000061 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use--(1) Amount--(i) Horses. Administer 100 to 400 
mg by intramuscular injection, repeating if necessary.
    (ii) Dogs and cats. Administer 0.25 to 1.0 mg per pound of body 
weight by intramuscular injection for 3 to 5 days or until a response is 
noted. Treatment may be continued with an orally administered dose.

[[Page 331]]

    (2) Indications for use. It is used for conditions requiring an 
anti-inflammatory agent.
    (3) Limitations. Do not use in horses intended for human 
consumption. Federal law restricts this drug to use by or on the order 
of a licensed veterinarian.

[79 FR 16194, Mar. 25, 2014]



Sec. 522.1920  Prochlorperazine and isopropamide.

    (a) Specifications. Each milliliter of solution contains 
prochlorperazine edisylate equivalent to 4 milligrams (mg) 
prochlorperazine and isopropamide iodide equivalent to 0.28 mg of 
isopropamide.
    (b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use--(1) Amount. (i) Dosage is administered by 
subcutaneous injection twice daily as follows:

------------------------------------------------------------------------
                                                             Dosage in
               Weight of animal in pounds                   milliliters
------------------------------------------------------------------------
Up to 4.................................................            0.25
5 to 14.................................................           0.5-1
15 to 30................................................             2-3
30 to 45................................................             3-4
45 to 60................................................             4-5
Over 60.................................................               6
------------------------------------------------------------------------

    (ii) Following the last injection, administer prochlorperazine and 
isopropamide sustained release capsules as indicated.
    (2) Indications for use. For use in dogs and cats in which 
gastrointestinal disturbances are associated with emotional stress.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[79 FR 16194, Mar. 25, 2014]



Sec. 522.1940  Progesterone and estradiol benzoate.

    (a) Sponsors. See sponsors in Sec. 510.600(c) of this chapter for 
use as in paragraph (c) of this section:
    (1) No. 054771 for use as in paragraphs (c)(1)(i)(A), (c)(1)(ii), 
(c)(1)(iii), (c)(2)(i)(A), (c)(2)(ii), (c)(2)(iii), and (c)(3) of this 
section.
    (2) No. 058198 for use as in paragraphs (c)(1) and (c)(2) of this 
section.
    (b) Related tolerances. See Sec. Sec. 556.240 and 556.540 of this 
chapter.
    (c) Conditions of use in cattle. It is used for implantation as 
follows:
    (1) Suckling beef calves--(i) Amount. (A) 100 milligrams (mg) 
progesterone and 10 mg estradiol benzoate (one implant consisting of 4 
pellets, each pellet containing 25 mg progesterone and 2.5 mg estradiol 
benzoate) per implant dose.
    (B) 100 mg progesterone and 10 mg estradiol benzoate (one implant 
consisting of 5 pellets, each of 4 pellets containing 25 mg progesterone 
and 2.5 mg estradiol benzoate, and 1 pellet containing 29 mg tylosin 
tartrate) per implant dose.
    (ii) Indications for use. For increased rate of weight gain.
    (iii) Limitations. For use in suckling beef calves (at least 45 days 
of age) up to 400 pounds (lb) of body weight. For subcutaneous ear 
implantation, one dose per animal. Do not use in bull calves intended 
for reproduction. Safety and effectiveness have not been established in 
veal calves. A withdrawal period has not been established for this 
product in preruminating calves. Do not use in calves to be processed 
for veal.
    (2) Steers--(i) Amount. (A) 200 mg progesterone and 20 mg estradiol 
benzoate (one implant consisting of 8 pellets, each pellet containing 25 
mg progesterone and 2.5 mg estradiol benzoate) per implant dose.
    (B) 200 mg progesterone and 20 mg estradiol benzoate (one implant 
consisting of 9 pellets, each of 8 pellets containing 25 mg progesterone 
and 2.5 mg estradiol benzoate, and 1 pellet containing 29 mg tylosin 
tartrate) per implant dose.
    (ii) Indications for use. For increased rate of weight gain and 
improved feed efficiency.
    (iii) Limitations. For animals weighing 400 lb or more; for 
subcutaneous ear implantation, one dose per animal. Safety and 
effectiveness have not been established in veal calves. A withdrawal 
period has not been established for this product in preruminating 
calves. Do not use in calves to be processed for veal.
    (3) Steers fed in confinement for slaughter--(i) Amount. Reimplant 
200 mg progesterone and 20 mg estradiol benzoate on approximately day 70 
following an initial implant of 100 mg progesterone and 10 mg estradiol 
benzoate or 200 mg

[[Page 332]]

progesterone and 20 mg estradiol benzoate.
    (ii) Indications for use. For additional improvement in rate of 
weight gain.
    (iii) Limitations. For subcutaneous ear implantation. Safety and 
effectiveness have not been established in veal calves. A withdrawal 
period has not been established for this product in preruminating 
calves. Do not use in calves to be processed for veal.

[69 FR 70055, Dec. 2, 2004, as amended at 77 FR 31723, May 30, 2012; 79 
FR 16194, Mar. 25, 2014; 81 FR 48702, July 26, 2016]



Sec. 522.1962  Promazine.

    (a) Specifications. Each milliliter of solution contains 50 
milligrams (mg) promazine hydrochloride.
    (b) Sponsors. See sponsors in Sec. 510.600(c) of this chapter for 
use as in paragraph (c) of this section:
    (1) No. 054771 for use as in paragraphs (c)(1)(i)(A), (c)(1)(ii)(A), 
(c)(1)(iii), and (c)(2) of this section.
    (2) No. 061133 for use as in paragraphs (c)(1)(i)(B), (c)(1)(ii)(B), 
and (c)(1)(iii) of this section.
    (c) Conditions of use--(1) Horses--(i) Amount. (A) 0.2 to 0.5 
milligrams per pounds (mg/lb) body weight intramuscularly or 
intravenously every 4 to 6 hours.
    (B) 0.2 to 0.5 mg/lb body weight intravenously as required.
    (ii) Indications for use. (A) For use as a tranquilizer, 
preanesthetic, or for minor operative procedures in conjunction with 
local anesthesia; and as adjunctive therapy for tetanus.
    (B) For use as a tranquilizer and preanesthetic.
    (iii) Limitations. Do not use in horses intended for human 
consumption. Federal law restricts this drug to use by or on the order 
of a licensed veterinarian.
    (2) Dogs and cats--(i) Amount. 1 to 2 mg/lb body weight 
intramuscularly or intravenously every 4 to 6 hours.
    (ii) Indications for use. For use as a tranquilizer, preanesthetic, 
for minor operative procedures in conjunction with local anesthesia, as 
adjunctive therapy for tetanus, and as an antiemetic prior to worming; 
or to prevent motion sickness in dogs.
    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

[46 FR 18962, Mar. 27, 1981, as amended at 68 FR 59881, Oct. 20, 2003; 
70 FR 50183, Aug. 26, 2005; 79 FR 16194, Mar. 25, 2014; 84 FR 8974, Mar. 
13, 2019]



Sec. 522.2002  Propiopromazine.

    (a) Specifications. Each milliliter of solution contains 5 or 10 
milligrams (mg) propiopromazine hydrochloride.
    (b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in dogs and cats--(1) Amounts and indications 
for use. Administer 0.05 to 0.5 mg per pound of body weight by 
intravenous or intramuscular injection for tranquilization. Administer 
0.25 mg per pound of body weight by intravenous injection as a 
preanesthetic.
    (2) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[79 FR 16195, Mar. 25, 2014]



Sec. 522.2005  Propofol.

    (a) Specifications. Each milliliter of emulsion contains 10 
milligrams (mg) propofol.
    (b) Sponsors. See sponsor numbers in Sec. 510.600(c) of this 
chapter.
    (1) No. 086064 for use as in paragraphs (c)(1), (c)(2)(i), and 
(c)(3) of this section.
    (2) No. 054771 for use as in paragraph (c) of this section.
    (c) Conditions of use in dogs and cats--(1) Amount. Administer by 
intravenous injection according to label directions. The use of 
preanesthetic medication reduces propofol dose requirements.
    (2) Indications for use. (i) As a single injection to provide 
general anesthesia for short procedures; for induction and maintenance 
of general anesthesia using incremental doses to effect; for induction 
of general anesthesia where maintenance is provided by inhalant 
anesthetics.
    (ii) For the induction and maintenance of anesthesia and for 
induction of anesthesia followed by maintenance with an inhalant 
anesthetic.

[[Page 333]]

    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[75 FR 20269, Apr. 19, 2010, as amended at 75 FR 38700, July 6, 2010; 78 
FR 17868, Mar. 25, 2013; 79 FR 16195, Mar. 25, 2014; 80 FR 18776, Apr. 
8, 2015; 81 FR 36789, June 8, 2016]



Sec. 522.2012  Prostalene.

    (a) Specifications. Each milliliter of solution contains 1 milligram 
of prostalene.
    (b) Sponsor. No. 054771 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in horses--(1) Amount. Administer 5 micrograms 
per kilogram of body weight as a single subcutaneous injection.
    (2) Indications for use. For the control of estrus in mares.
    (3) Limitations. Do not use in horses intended for human 
consumption. Federal law restricts this drug to use by or on the order 
of a licensed veterinarian.

[79 FR 16195, Mar. 25, 2014]



Sec. 522.2063  Pyrilamine.

    (a) Specifications. Each milliliter of solution contains 20 
milligrams (mg) of pyrilamine maleate.
    (b) Sponsors. See sponsor numbers in Sec. 510.600(c) of this 
chapter for uses in paragraph (c) of this section.
    (1) No. 000061 for use as in paragraph (c)(1)(i), (2), and (3) of 
this section.
    (2) No. 061133 for use as in paragraph (c)(1)(ii), (2), and (3) of 
this section.
    (c) Conditions of use--(1) Amount. (i) Horses, 40 to 60 mg per 100 
pounds (lbs) body weight; foals, 20 mg/100 lbs body weight. Administer 
by intramuscular, subcutaneous, or intravenous injection. Dosage may be 
repeated every 6 to 12 hours whenever necessary.
    (ii) Horses, 40 to 60 mg/100 lbs body weight; foals, 20 mg/100 lbs 
body weight. Administer by slow intravenous injection. Dosage may be 
repeated every 6 to 12 hours if necessary.
    (2) Indications for use. It is intended for treating horses in 
conditions in which antihistaminic therapy may be expected to lead to 
alleviation of some signs of disease.
    (3) Limitations. Do not use in horses intended for human 
consumption. Federal law restricts this drug to use by or on the order 
of a licensed veterinarian.

[79 FR 16195, Mar. 25, 2014, as amended at 84 FR 8974, Mar. 13, 2019]



Sec. 522.2075  Robenacoxib.

    (a) Specifications. Each milliliter of solution contains 20 
milligrams (mg) robenacoxib.
    (b) Sponsor. See No. 058198 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use--(1) Dogs--(i) Amount. Administer 0.91 mg per 
pound (2 mg/kilogram (kg)) by subcutaneous injection, once daily, for a 
maximum of 3 days. After the initial subcutaneous dose, subsequent doses 
can be given by subcutaneous injection or as the oral tablet in dogs 
weighing at least 5.5 pounds (2.5 kg) and at least 4 months of age, for 
a maximum of 3 total doses over 3 days, not to exceed 1 dose per day. 
See Sec. 520.2075(c)(1) of this chapter.
    (ii) Indications for use. For the control of postoperative pain and 
inflammation associated with soft tissue surgery in dogs at least 4 
months of age for a maximum of 3 days.
    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.
    (2) Cats--(i) Amount. Administer 0.91 mg per pound (2 mg/kg) by 
subcutaneous injection, once daily, for a maximum of 3 days.
    (ii) Indications for use. For the control of postoperative pain and 
inflammation associated with orthopedic surgery, ovariohysterectomy, and 
castration in cats at least 4 months of age for a maximum of 3 days.
    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

[80 FR 61297, Oct. 13, 2015, as amended at 82 FR 12170, Mar. 1, 2017]



Sec. 522.2076  Romifidine.

    (a) Specifications. Each milliliter of solution contains 10 
milligrams (mg) romifidine hydrochloride.
    (b) Sponsor. See No. 000010 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in horses--(1) Amount. 40 to 120 micrograms 
per kilogram of body weight (mcg/kg BW) intravenously for sedation and 
analgesia;

[[Page 334]]

100 mcg/kg BW intravenously as a preanesthetic.
    (2) Indications for use. For use as a sedative and analgesic to 
facilitate handling, clinical examinations, clinical procedures, and 
minor surgical procedures in adult horses; and for use as a 
preanesthetic prior to the induction of general anesthesia in adult 
horses.
    (3) Limitations. Do not use in horses intended for human 
consumption. Federal law restricts this drug to use by or on the order 
of a licensed veterinarian.

[69 FR 47363, Aug. 5, 2004, as amended at 79 FR 16195, Mar. 25, 2014]



Sec. 522.2092  Secobarbital and dibucaine.

    (a) Specifications. Each milliliter (mL) of solution contains 400 
milligram (mg) secobarbital sodium and 25 mg dibucaine hydrochloride.
    (b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
    (c) Special considerations. Product labeling shall bear the 
following warning statements: ``ENVIRONMENTAL HAZARD: This product is 
toxic to wildlife. Birds and mammals feeding on treated animals may be 
killed. Euthanized animals must be properly disposed of by deep burial, 
incineration, or other method in compliance with State and local laws, 
to prevent consumption of carcass material by scavenging wildlife.''
    (d) Conditions of use in dogs--(1) Amount. Administer 1 mL per 10 
pounds of body weight as a single, bolus intravenous injection.
    (2) Indications for use. For humane, painless, and rapid euthanasia.
    (3) Limitations. Do not use in animals intended for food. Federal 
law restricts this drug to use by or on the order of a licensed 
veterinarian.

[85 FR 18120, Apr. 1, 2020]



Sec. 522.2100  Selenium and vitamin E.

    (a)(1) Specifications. Each milliliter of emulsion contains 5.48 
milligrams (mg) sodium selenite (equivalent to 2.5 mg selenium) and 50 
mg of vitamin E (68 I.U.) (as d-alpha tocopheryl acetate).
    (2) Sponsor. See No. 000061 in Sec. 510.600(c) of this chapter.
    (3) Conditions of use in horses--(i) Amount. Administer 1 milliliter 
(mL) per (/) 100 pounds (lbs) of body weight by intravenous injection or 
by deep intramuscular injection in divided doses in two or more sites in 
the gluteal or cervical muscles. Administration may be repeated at 5 to 
10 day intervals.
    (ii) Indications for use. For the prevention and treatment of 
selenium-tocopherol deficiency syndrome in horses.
    (iii) Limitations. Do not use in horses intended for human 
consumption. Federal law restricts this drug to use by or on the order 
of a licensed veterinarian.
    (b)(1) Specifications. Each milliliter contains 2.19 mg of sodium 
selenite (equivalent to 1 mg of selenium), 50 mg of vitamin E (68 I.U.) 
(as d-alpha tocopheryl acetate).
    (2) Sponsor. See No. 000061 in Sec. 510.600(c) of this chapter.
    (3) Conditions of use in dogs--(i) Amount. Administer by 
subcutaneous or intramuscular injection in divided doses in two or more 
sites at 1 mL/20 lbs of body weight with a minimum dosage of \1/4\ mL 
and a maximum dosage of 5 mL. The dose is repeated at 3-day intervals 
until a satisfactory therapeutic response is observed. A maintenance 
regimen is then initiated which consists of 1 mL per 40 lbs of body 
weight with a minimum dosage of \1/4\ mL which is repeated every 3 days 
or 7 days, or longer, as required to maintain continued improvement or 
an asymptomatic condition; or the drug may be used in capsule form for 
oral maintenance therapy.
    (ii) Indications for use. As an aid in alleviating and controlling 
inflammation, pain, and lameness associated with certain arthropathies 
in dogs.
    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.
    (c)(1) Specifications. Each milliliter contains 2.19 milligrams of 
selenite sodium (equivalent to 1 milligram selenium), 50 milligrams 
vitamin E (68 U.S.P. units).
    (2) Sponsor. See No. 000061 in Sec. 510.600(c) of this chapter.
    (3) Conditions of use--(i) Dosage. Calves: 2.5 to 3.75 milliliters 
per 100 pounds of body weight. Lambs 2 weeks of age or older: 1 
milliliter per 40 pounds, minimum 1 milliliter. Ewes: 2.5

[[Page 335]]

milliliters per 100 pounds. Sows: 1 milliliter per 40 pounds. Weanling 
pigs: 1 milliliter per 40 pounds, minimum 1 milliliter.
    (ii) Indications for use. Calves, lambs, and ewes: prevention and 
treatment of white muscle disease (selenium-tocopherol deficiency 
syndrome). Sows and weanling pigs: an aid in the prevention and 
treatment of selenium-tocopherol deficiency.
    (iii) Limitations. For subcutaneous or intramuscular use. Not for 
use in newborn pigs. Do not use in pregnant ewes. Calves: Discontinue 
use 30 days before treated calves are slaughtered for human consumption. 
Lambs, ewes, sows, or pigs: Discontinue use 14 days before treated 
lambs, ewes, sows, or pigs are slaughtered for human consumption. 
Federal law restricts this drug to use by or on the order of a licensed 
veterinarian.
    (d)(1) Specifications. Each milliliter contains 10.95 milligrams 
selenite sodium (equivalent to 5 milligrams selenium), 50 milligrams 
vitamin E (68 U.S.P. units).
    (2) Sponsors. See Nos. 000061 and 054771 in Sec. 510.600(c) of this 
chapter.
    (3) Conditions of use--(i) Dosage. Breeding beef cows: 1 milliliter 
per 200 pounds of body weight during the middle third of gestation, and 
30 days before calving. Weanling calves: 1 milliliter per 200 pounds of 
body weight.
    (ii) Indications for use. Weanling calves and breeding beef cows: 
For the prevention and treatment of selenium-tocopherol deficiency 
syndrome.
    (iii) Limitations. For subcutaneous or intramuscular use. 
Discontinue use 30 days before treated cattle are slaughtered for human 
consumption. Federal law restricts this drug to use by or on the order 
of a licensed veterinarian.
    (e)(1) Specifications. Each milliliter contains 0.55 milligram 
selenite sodium (equivalent to 0.25 milligram selenium), 50 milligrams 
(68 U.S.P. units) vitamin E.
    (2) Sponsor. See No. 000061 in Sec. 510.600(c) of this chapter.
    (3) Conditions of use--(i) Dosage. Newborn lambs: 1 milliliter. 
Lambs 2 weeks of age or older: 4 milliliters. Baby pigs: 1 milliliter 
(or treat the sow during the last week of pregnancy).
    (ii) Indications for use. Lambs: for prevention and treatment of 
white muscle disease (selenium-tocopherol deficiency syndrome). Baby 
pigs: an aid in the prevention and treatment of selenium-tocopherol 
deficiency.
    (iii) Limitations. For subcutaneous or intramuscular use only. 
Discontinue use 14 days before treated animals are slaughtered for human 
consumption. Federal law restricts this drug to use by or on the order 
of a licensed veterinarian.

[40 FR 13858, Mar. 27, 1975, as amended at 52 FR 7832, Mar. 13, 1987; 57 
FR 21209, May 19, 1992; 58 FR 57556, Oct. 26, 1993; 60 FR 57833, Nov. 
22, 1995; 64 FR 27916, May 24, 1999; 79 FR 16195, Mar. 25, 2014]



Sec. 522.2112  Sometribove zinc suspension.

    (a) Specifications. Each single-dose syringe contains 500 milligrams 
(mg) sometribove zinc in a prolonged-release suspension.
    (b) Sponsor. See No. 086106 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use--(1) Amount. Inject 500 mg every 14 days 
starting during the 9th or 10th week (57 to 70 days) after calving and 
continue until the end of lactation.
    (2) Indications for use. To increase production of marketable milk 
in healthy lactating dairy cows.
    (3) Limitations. Use in lactating dairy cows only. Safety to 
replacement bulls born to treated dairy cows has not been established. 
Inject subcutaneously. Avoid injections within 2 weeks of expected 
slaughter to minimize injection site blemishes on carcass. There is no 
milk discard or preslaughter withdrawal period. Use may reduce pregnancy 
rates and increase days open. Treated cows are at an increased risk for 
mastitis and higher milk somatic cell counts. Use care to differentiate 
increased body temperature due to use of this product from an increased 
body temperature that may occur due to illness. Cows treated with this 
product may have more enlarged hocks and disorders of the foot region. 
Use may reduce hemoglobin and hematocrit values during treatment. Human 
warning:

[[Page 336]]

Avoid prolonged or repeated contact with eyes and skin.

[58 FR 59947, Nov. 12, 1993, as amended at 67 FR 18085, Apr. 15, 2002; 
68 FR 62006, Oct. 31, 2003; 74 FR 53164, Oct. 16, 2009; 81 FR 48702, 
July 26, 2016; 85 FR 4208, Jan. 24, 2020]



Sec. 522.2120  Spectinomycin hydrochloride.

    (a) Specifications. Each milliliter of solution contains 100 
milligrams (mg) spectinomycin hydrochloride (as spectinomycin 
dihydrochloride pentahydrate).
    (b) Sponsors. See sponsors in Sec. 510.600(c) of this chapter:
    (1) Nos. 016592 and 054771 for use as in paragraph (d)(1) of this 
section; and
    (2) No. 058198 for use as in paragraph (d)(2) of this section.
    (c) Related tolerances. See Sec. 556.600 of this chapter.
    (d) Conditions of use. It is administered as follows:
    (1) Turkeys (1- to 3-day-old poults) and chickens (newly hatched 
chicks)--(i) Amounts and indications for use. (A) Administer 5 mg per 
poult subcutaneously as an aid in the control of chronic respiratory 
disease (CRD) associated with Escherichia coli in 1- to 3-day-old turkey 
poults.
    (B) Administer 10 mg per poult as a single subcutaneous injection in 
the nape of the neck as an aid in the control of airsacculitis 
associated with Mycoplasma meleagridis sensitive to spectinomycin in 1- 
to 3-day-old turkey poults.
    (C) Administer 2.5 to 5 mg per chick as an aid in the control of 
mortality and to lessen severity of infections caused by M. synoviae, 
Salmonella typhimurium, S. infantis, and E. coli.
    (ii) Limitations. For use only in 1- to 3-day-old turkey poults and 
newly hatched chicks.
    (2) Dogs--(i) Amount. Administer 2.5 to 5.0 mg per pound of body 
weight by intramuscular injection twice daily. Treatment may be 
continued for 4 days.
    (ii) Indications for use. For treatment of infections caused by 
gram-negative and gram-positive organisms susceptible to spectinomycin.
    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

[86 FR 14820, Mar. 19, 2021]



Sec. 522.2121  Spectinomycin sulfate.

    (a) Specifications. Each milliliter of solution contains 
spectinomycin sulfate tetrahydrate equivalent to 100 milligrams (mg) 
spectinomycin.
    (b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
    (c) Related tolerances. See Sec. 556.600 of this chapter.
    (d) Conditions of use in cattle--(1) Amount. 10 to 15 mg per 
kilogram of body weight at 24-hour intervals for 3 to 5 consecutive 
days.
    (2) Indications for use. For the treatment of bovine respiratory 
disease (pneumonia) associated with Mannheimia haemolytica, Pasteurella 
multocida, and Histophilus somni.
    (3) Limitations. Do not slaughter within 11 days of last treatment. 
Do not use in female dairy cattle 20 months of age or older. Use in this 
class of cattle may cause residues in milk. A withdrawal period has not 
been established for this product in preruminating calves. Do not use in 
calves to be processed for veal. Federal law restricts this drug to use 
by or on the order of a licensed veterinarian.

[72 FR 31178, June 6, 2007, as amended at 79 FR 16195, Mar. 25, 2014]



Sec. 522.2150  Stanozolol.

    (a) Specifications. Each milliliter of suspension contains 50 
milligrams (mg) of stanozolol.
    (b) Sponsor. No. 054771 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use--(1) Amount--(i) Dogs and cats. For cats and 
small breeds of dogs: 25 mg. For larger dogs: 50 mg. Administer by deep 
intramuscular injection in the thigh at weekly intervals, for several 
weeks.
    (ii) Horses. Administer 25 mg per 100 pounds of body weight by deep 
intramuscular injection in the gluteal region at weekly intervals, for 
not more than 4 weeks.
    (2) Indications for use. For use as an anabolic steroid treatment.

[[Page 337]]

    (3) Limitations. Do not use in horses intended for human 
consumption. Federal law restricts this drug to use by or on the order 
of a licensed veterinarian.

[79 FR 16195, Mar. 25, 2014]



Sec. 522.2200  Sulfachlorpyridazine.

    (a) Specifications. Each milliliter of solution contains sodium 
sulfachlorpyridazine equivalent to 200 milligrams (mg) 
sulfachlorpyridazine.
    (b) Sponsor. See No. 000010 in Sec. 510.600(c) of this chapter.
    (c) Related tolerances. See Sec. 556.630 of this chapter.
    (d) Conditions of use in calves. It is used as follows:
    (1) Amount. Administer 30 to 45 mg per pound (/lb) of body weight in 
divided doses by twice daily injection for 1 to 5 days.
    (2) Indications for use. For the treatment of diarrhea caused or 
complicated by Escherichia coli (colibacillosis).
    (3) Limitations. Treated calves must not be slaughtered for food 
during treatment or for 5 days after the last treatment. A withdrawal 
period has not been established for this product in preruminating 
calves. Do not use in calves to be processed for veal.

[75 FR 10167, Mar. 5, 2010]



Sec. 522.2220  Sulfadimethoxine.

    (a) Specifications. Each milliliter of solution contains:
    (1) 100 milligrams (mg) of sulfadimethoxine sodium.
    (2) 400 mg of sulfadimethoxine sodium.
    (b) Sponsors. See sponsor numbers in Sec. 510.600(c) of this 
chapter for use as in paragraph (d) of this section.
    (1) No. 069043 for use of the product described in paragraph (a)(1) 
as in paragraph (d)(1) of this section.
    (2) No. 054771 for use of the product described in paragraph (a)(2) 
as in paragraphs (d)(2), (3), and (4) of this section.
    (3) Nos. 016592 and 061133 for use of the product described in 
paragraph (a)(2) as in paragraph (d)(4) of this section.
    (c) Related tolerances. See Sec. 556.640 of this chapter.
    (d) Conditions of use--(1) Dogs--(i) Amount. Administer by 
subcutaneous, intramuscular, or intravenous injection at an initial dose 
of 25 mg per pound of body weight followed by 12.5 mg per pound of body 
weight every 24 hours thereafter. Continue treatment until the animal is 
free from symptoms for 48 hours.
    (ii) Indications for use. For use in the treatment of 
sulfadimethoxine-susceptible bacterial infections in dogs.
    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.
    (2) Dogs and cats--(i) Amount. Administer by intravenous or 
subcutaneous injection at an initial dose of 55 mg per kilogram of body 
weight followed by 27.5 mg per kilogram of body weight every 24 hours.
    (ii) Indications for use. For the treatment of respiratory, 
genitourinary tract, enteric, and soft tissue infections when caused by 
Streptococci, Staphylococci, Escherichia, Salmonella, Klebsiella, 
Proteus, or Shigella organisms sensitive to sulfadimethoxine, and in the 
treatment of canine bacterial enteritis associated with coccidiosis and 
canine Salmonellosis.
    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.
    (3) Horses--(i) Amount. Administer by intravenous injection at an 
initial dose of 55 mg per kilogram of body weight followed by 27.5 mg 
per kilogram of body weight every 24 hours until the patient is 
asymptomatic for 48 hours.
    (ii) Indications for use. For the treatment of respiratory disease 
caused by Streptococcus equi (strangles).
    (iii) Limitations. Do not use in horses intended for human 
consumption. Federal law restricts this drug to use by or on the order 
of a licensed veterinarian.
    (4) Cattle--(i) Amount. Administer an initial dose of 25 mg per 
pound of body weight by intravenous injection followed by 12.5 mg per 
pound of body weight every 24 hours until the animal is asymptomatic for 
48 hours.
    (ii) Indications for use. For the treatment of bovine respiratory 
disease complex (shipping fever complex) and bacterial pneumonia 
associated with Pasteurella spp. sensitive to sulfadimethoxine; necrotic 
pododermatitis (foot rot) and calf diphtheria caused by Fusobacterium

[[Page 338]]

necrophorum sensitive to sulfadimethoxine.
    (iii) Limitations. Milk taken from animals during treatment and for 
60 hours (5 milkings) after the latest treatment must not be used for 
food. Do not administer within 5 days of slaughter. A withdrawal period 
has not been established for this product in preruminating calves. Do 
not use in calves to be processed for veal.

[79 FR 16196, Mar. 25, 2014, as amended at 81 FR 22524, Apr. 18, 2016; 
83 FR 48946, Sept. 28, 2018; 84 FR 8974, Mar. 13, 2019]



Sec. 522.2240  Sulfaethoxypyridazine.

    (a) Specifications. The drug is an aqueous solution of 
sulfaethoxypyridazine.
    (b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
    (c) Related tolerances. See Sec. 556.650 of this chapter.
    (d) Conditions of use in cattle--(1) Amount. Administer 2.5 grams 
per 100 pounds of body weight per day by intravenous injection for not 
more than 4 days; or first treatment may be followed by 3 days of 
treatment with sulfaethoxypyridazine in drinking water or tablets in 
accordance with Sec. Sec. 520.2240a(e) and 520.2240b(e) of this 
chapter.
    (2) Indications for use. For treatment of respiratory infection 
(pneumonia, shipping fever), foot rot, calf scours; as adjunctive 
therapy in septicemia accompanying mastitis and metritis.
    (3) Limitations. Do not treat within 16 days of slaughter. Milk that 
has been taken from animals during treatment and for 72 hours (6 
milkings) after the latest treatment must not be used for food. Federal 
law restricts this drug to use by or on the order of a licensed 
veterinarian.

[79 FR 16196, Mar. 25, 2014]



Sec. 522.2260  Sulfamethazine.

    (a) Specifications. Each milliliter (mL) of solution contains 250 
milligrams (mg) sulfamethazine sodium.
    (b) Sponsor. See No. 016592 in Sec. 510.600(c) of this chapter.
    (c) Related tolerances. See Sec. 556.670 of this chapter.
    (d) Conditions of use in cattle--(1) Amount. Initially administer 20 
mL for each 50 pounds (lb) of body weight (100 mg/lb) by intravenous 
injection, followed by 20 mL per 100 lb of body weight (50 mg/lb) by 
intravenous injection, daily thereafter. Treatment should not exceed a 
total of 5 consecutive days.
    (2) Indications for use. For cattle for treatment of bacterial 
pneumonia and bovine respiratory disease complex (shipping fever 
complex) (Pasteurella spp.), colibacillosis (bacterial scours) 
(Escherichia coli), necrotic pododermatitis (foot rot) (Fusobacterium 
necrophorum), calf diphtheria (Fusobacterium necrophorum), acute 
mastitis and acute metritis (Streptococcus spp.) when caused by one or 
more pathogenic organisms sensitive to sulfamethazine.
    (3) Limitations. Withdraw medication from cattle 10 days prior to 
slaughter. Do not use in female dairy cattle 20 months of age or older. 
Federal law restricts this drug to use by or on the order of a licensed 
veterinarian.

[46 FR 62055, Dec. 22, 1981, as amended at 67 FR 78355, Dec. 24, 2002; 
75 FR 10167, Mar. 5, 2010; 76 FR 53051, Aug. 25, 2011; 81 FR 17608, Mar. 
30, 2016]



Sec. 522.2340  Sulfomyxin.

    (a) Specifications. Sulfomyxin for injection is sterile. It is 
derived from the antibiotic substance produced by the growth of Bacillus 
polymyxa or is the same substance produced by any other means.
    (b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
    (c) Special considerations. The quantities of antibiotic in 
paragraph (e) of this section refer to the activity of the appropriate 
standard.
    (d) Related tolerances. See Sec. 556.700 of this chapter.
    (e) Conditions of use. (1) It is used or intended for use in 
chickens and turkeys as an aid in the treatment of disease caused or 
complicated by E. coli, such as colibacillosis and complicated chronic 
respiratory disease.
    (2) It is administered by subcutaneous injection as follows:

------------------------------------------------------------------------
                                                    Antibiotic activity
                                                 -----------------------
              Age of birds in days                 Chickens     Turkeys
                                                    (units)     (units)
------------------------------------------------------------------------
1 to 14.........................................      12,500      12,500
15 to 28........................................      25,000      25,000

[[Page 339]]

 
29 to 63........................................      50,000      50,000
Over 63.........................................      50,000     100,000
------------------------------------------------------------------------

    (3) A second injection may be given 3 days later if symptoms 
persist.
    (4) Not for use in laying hens; do not treat chickens within 5 days 
of slaughter; do not treat turkeys within 7 days of slaughter.

[40 FR 13858, Mar. 27, 1975, as amended at 79 FR 16196, Mar. 25, 2014]



Sec. 522.2404  Thialbarbitone sodium for injection.

    (a) Specifications. Thialbarbitone sodium for injection when 
reconstituted with sterile distilled water provides 94 milligrams of 
thialbarbitone sodium per milliliter of solution.
    (b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use. (1) The drug is administered as a general 
anesthetic in surgical procedures on dogs, cats, swine, sheep, cattle, 
and horses. The drug is used for procedures of relatively short 
duration. However, the period of anesthesia can be lengthened by slower 
initial injection and supplemental administration during surgery.
    (2) It is administered intravenously. The drug is injected slowly to 
dogs, cats, cattle, sheep, and swine. For horses, it is recommended that 
a pre-anesthetic sedation be administered to the horse 30 minutes before 
the drug is administered. The drug is then injected rapidly and 
completely. The drug is used at the following dosage levels:

------------------------------------------------------------------------
                                                               Dosage in
               Species                  Weight of animal in   milligrams
                                              pounds           per pound
------------------------------------------------------------------------
Dog.................................  Over 50...............        14.1
 Do.................................  30-50.................        18.8
 Do.................................  10-30.................        23.5
 Do.................................  Under 10..............        28.2
Cat.................................  ......................   31.3-37.6
Horse...............................  ......................     6.3-7.8
Cattle and swine....................  ......................     6.7-9.4
Calves and sheep....................  ......................    9.4-11.8
------------------------------------------------------------------------

    (3) Federal law restricts this drug to use by or on the order of a 
licensed veterinarian.

[40 FR 13858, Mar. 27, 1975, as amended at 79 FR 16196, Mar. 25, 2014]



Sec. 522.2424  Thiamylal.

    (a) Specifications. The drug is a sterile powder. It is 
reconstituted with sterile distilled water, water for injection, or 
sodium chloride injection, to a desired concentration of 0.5 to 4 
percent sodium thiamylal.
    (b) Sponsors. See Nos. 054771 and 069043 in Sec. 510.600(c) of this 
chapter.
    (c) Conditions of use--(1) Amount. Administer by intravenous 
injection to effect. The average single dose is:
    (i) Dogs and cats: 8 milligrams (mg) per pound of body weight (when 
used with a preanesthetic, generally one-half the normal dose).
    (ii) Swine: 40 mg per 5 pounds (lbs) of body weight.
    (iii) Horses: Light anesthesia, 1 gram per 500 lbs to 1,100 lbs of 
body weight; deep anethesia, 1 gram per 300 lbs of body weight (40 mg/12 
lbs of body weight).
    (iv) Cattle: Short duration, 20 mg/5 lbs of body weight; longer 
duration, 40 mg/7 lbs of body weight.
    (2) Indications for use. It is used as an ultra-short-acting 
anesthetic in dogs, cats, swine, horses, and cattle.
    (3) Limitations. Do not use in horses intended for human 
consumption. Federal law restricts this drug to use by or on the order 
of a licensed veterinarian.

[79 FR 16196, Mar. 25, 2014, as amended at 83 FR 48946, Sept. 28, 2018]



Sec. 522.2444  Thiopental injectable dosage forms.



Sec. 522.2444a  Thiopental powder for injection.

    (a) Specifications. The drug contains sodium thiopental powder for 
constitution with sterile water for injection.
    (b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in dogs and cats--(1) Amount. Administer by 
intravenous injection as follows:
    (i) 6 to 9 milligrams (mg) per pound of body weight for brief 
anesthesia (6 to 10 minutes).
    (ii) 10 to 12 mg per pound of body weight for anesthesia of 15 to 25 
minutes duration.
    (2) Indications for use. It is used as an anesthetic for intravenous 
administration to dogs and cats during short to moderately long surgical 
and other

[[Page 340]]

procedures. It is also used to induce anesthesia in dogs and cats which 
then have surgical anesthesia maintained by use of a volatile 
anesthetic.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[79 FR 16196, Mar. 25, 2014]



Sec. 522.2444b  Thiopental and pentobarbital powder for injection.

    (a) Specifications. Each gram of powder contains 750 milligrams (mg) 
of sodium thiopental and 250 mg of sodium pentobarbital powder for 
dilution with sterile water for injection.
    (b) Sponsor. See No. 061133 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use--(1) Amount. For total anesthesia, it is given 
at approximately 10 to 12 mg per pound of body weight over a period of 
3.5 to 5 minutes. When preanesthetic medication is used, wait at least 
an hour before administering thiopental and sodium pentobarbital for 
injection, and the dosage necessary for anesthesia is reduced. Usually 
\1/2\ to \2/3\ the normal amount is adequate.
    (2) Indications for use. It is used as an anesthetic for intravenous 
administration to dogs and cats during short to moderately long surgical 
procedures.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[79 FR 16197, Mar. 25, 2014, as amended at 84 FR 8974, Mar. 13, 2019]



Sec. 522.2450  Tigilanol.

    (a) Specifications. Each milliliter (mL) of solution contains 1 
milligram tigilanol tiglate.
    (b) Sponsor. See No. 086132 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in dogs--(1) Amount. Administer as an 
intratumoral injection at a dose of 0.5 mL per cubic centimeter of tumor 
volume.
    (2) Indications for use. For the treatment of non-metastatic 
cutaneous mast cell tumors and non-metastatic subcutaneous mast cell 
tumors located at or distal to the elbow or the hock in dogs.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[86 FR 17064, Apr. 1, 2021]



Sec. 522.2460  Tildipirosin.

    (a) Specifications. Each milliliter of solution contains:
    (1) 180 milligrams (mg) tildipirosin.
    (2) [Reserved]
    (b) Sponsor. See No. 000061 in Sec. 510.600(c) of this chapter.
    (c) Related tolerances. See Sec. 556.733 of this chapter.
    (d) Conditions of use--(1) Cattle--(i) Amount. Administer 4 mg/kg of 
bodyweight one time by subcutaneous injection in the neck.
    (ii) Indications for use. For the treatment of bovine respiratory 
disease (BRD) associated with Mannheimia haemolytica, Pasteurella 
multocida, and Histophilus somni in beef and non-lactating dairy cattle; 
and for the control of respiratory disease in beef and non-lactating 
dairy cattle at high risk of developing BRD associated with M. 
haemolytica, P. multocida, and H. somni.
    (iii) Limitations. Cattle intended for human consumption must not be 
slaughtered within 21 days from the last treatment. Do not use in female 
dairy cattle 20 months of age or older. A withdrawal period has not been 
established for this product in preruminating calves. Do not use in 
calves to be processed for veal. Federal law restricts this drug to use 
by or on the order of a licensed veterinarian.
    (2) [Reserved]

[77 FR 39391, July 3, 2012]



Sec. 522.2470  Tiletamine and zolazepam for injection.

    (a) Specifications. The drug is a sterile powder. Each milliliter of 
constituted solution contains tiletamine hydrochloride equivalent to 50 
milligrams (mg) of tiletamine base and zolazepam hydrochloride 
equivalent to 50 mg of zolazepam base.
    (b) Sponsors. See sponsors in Sec. 510.600(c) of this chapter:
    (1) Nos. 026637 and 054771 for use as in paragraph (c) of this 
section.
    (2) No. 051311 for use as in paragraphs (c)(1)(i)(A), (c)(1)(ii)(A), 
(c)(1)(iii), and (c)(2) of this section.

[[Page 341]]

    (c) Conditions of use--(1) Dogs--(i) Amount. Expressed as milligrams 
of the drug combination:
    (A) An initial intramuscular dosage of 3 to 4.5 milligrams per pound 
(mg/lb) of body weight for diagnostic purposes; 4.5 to 6 mg/lb of body 
weight for minor procedures of short duration such as repair of 
lacerations and wounds, castrations, and other procedures requiring mild 
to moderate analgesia. Supplemental doses when required should be less 
than the initial dose and the total dose given should not exceed 12 mg/
lb of body weight. The maximum total safe dose is 13.6 mg/lb of body 
weight.
    (B) Administer intravenously at 1 to 2 mg/lb (2.2 to 4.4 mg/kg) body 
weight to effect for induction of anesthesia followed by maintenance 
with an inhalant anesthetic.
    (ii) Indications for use. (A) Intramuscular administration in dogs 
for restraint and minor procedures of short duration (30 minutes 
average) requiring mild to moderate analgesia.
    (B) Intravenous administration in dogs for induction of anesthesia 
followed by maintenance with an inhalant anesthetic.
    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.
    (2) Cats--(i) Amount. An initial intramuscular dosage of 4.4 to 5.4 
mg/lb of body weight is recommended for such procedures as dentistry, 
treatment of abscesses, foreign body removal, and related types of 
surgery; 4.8 to 5.7 mg/lb of body weight for minor procedures requiring 
mild to moderate analgesia, such as repair of lacerations, castrations, 
and other procedures of short duration. Initial dosages of 6.5 to 7.2 
mg/lb of body weight are recommended for ovariohysterectomy and 
onychectomy. When supplemental doses are required, such individual 
supplemental doses should be given in increments that are less than the 
initial dose and the total dose given (initial dose plus supplemental 
doses) should not exceed the maximum allowable safe dose of 32.7 mg/lb 
of body weight.
    (ii) Indications for use. For restraint or for anesthesia combined 
with muscle relaxation.
    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

[79 FR 16197, Mar. 25, 2014, as amended at 83 FR 14587, Apr. 5, 2018; 86 
FR 17064, Apr. 1, 2021]



Sec. 522.2471  Tilmicosin.

    (a) Specifications. Each milliliter of solution contains 300 
milligrams (mg) tilmicosin base as tilmicosin phosphate.
    (b) Sponsor. See No. 058198 in Sec. 510.600(c) of this chapter.
    (c) Related tolerances. See Sec. 556.735 of this chapter.
    (d) Special considerations. (1) Not for human use. Use of this 
antibiotic in humans may prove fatal. Do not use in automatically 
powered syringes.
    (2) Federal law restricts this drug to use by or on the order of a 
licensed veterinarian.
    (e) Conditions of use--(1) Cattle--(i) Amount. 10 to 20 milligrams 
per kilograms (mg/kg) of body weight as a single subcutaneous injection.
    (ii) Indications for use. For the treatment of bovine respiratory 
disease (BRD) associated with Mannheimia haemolytica, Pasteurella 
multocida, and Histophilus somni. For the control of respiratory disease 
in cattle at high risk of developing BRD associated with M. haemolytica.
    (iii) Limitations. Do not use in female dairy cattle 20 months of 
age or older. Use of this antibiotic in this class of cattle may cause 
milk residues. Do not slaughter within 42 days of last treatment.
    (2) Sheep--(i) Amount. 10 mg/kg body weight as a single subcutaneous 
injection.
    (ii) Indications for use. For the treatment of ovine respiratory 
disease (ORD) associated with Mannheimia (P.) haemolytica.
    (iii) Limitations. Do not slaughter within 28 days of last 
treatment.

[67 FR 72367, Dec. 5, 2002, as amended at 75 FR 9334, Mar. 2, 2010; 81 
FR 48703, July 26, 2016]



Sec. 522.2473  Tiludronate.

    (a) Specifications. Each vial of powder contains 500 milligrams (mg) 
tiludronate disodium. Each milliliter

[[Page 342]]

of constituted solution contains 20 mg tiludronate disodium.
    (b) Sponsor. See No. 061133 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in horses--(1) Amount. Administer a single 
dose of 1 mg per kilogram (0.45 mg/pound) of body weight by intravenous 
infusion.
    (2) Indication for use. For the control of clinical signs associated 
with navicular syndrome.
    (3) Limitations. Do not use in horses intended for human 
consumption. Federal law restricts this drug to use by or on the order 
of a licensed veterinarian.

[79 FR 18159, Apr. 1, 2014, as amended at 82 FR 21691, May 10, 2017; 84 
FR 8974, Mar. 13, 2019]



Sec. 522.2474  Tolazoline.

    (a) Specifications. Each milliliter of solution contains tolazoline 
hydrochloride equivalent to 100 milligrams (mg) of base activity.
    (b) Sponsor. See No. 059399 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in horses--(1) Amount. Administer slowly by 
intravenous injection 4 mg per kilogram of body weight or 1.8 mg per 
pound (4 milliliters (mL) per 100 kilograms or 4 mL per 220 pounds).
    (2) Indications for use. For use in horses when it is desirable to 
reverse the effects of sedation and analgesia caused by xylazine.
    (3) Limitations. Do not use in horses intended for human 
consumption. Federal law restricts this drug to use by or on the order 
of a licensed veterinarian.

[79 FR 16197, Mar. 25, 2014, as amended at 79 FR 74020, Dec. 15, 2014; 
80 FR 13230, Mar. 13, 2015]



Sec. 522.2476  Trenbolone acetate.

    (a) Sponsors. See sponsors in Sec. 510.600(c) of this chapter for 
use as in paragraph (d) of this section.
    (1) No. 058198 for use as in paragraph (c) of this section.
    (2) No. 000061 for use as in paragraphs (c)(1)(i)(A), (c)(1)(ii), 
(c)(1)(iii), (c)(2)(i)(A), (c)(2)(ii), and (c)(2)(iii) of this section.
    (b) Related tolerances. See Sec. 556.739 of this chapter.
    (c) Conditions of use--(1) Steers fed in confinement for slaughter--
(i) Amount. Use 126 days prior to slaughter; should be reimplanted once 
after 63 days.
    (A) 140 milligrams (mg) trenbolone acetate (one implant consisting 
of 7 pellets, each pellet containing 20 mg trenbolone acetate) per 
implant dose.
    (B) 140 mg trenbolone acetate (one implant consisting of 8 pellets, 
each of 7 pellets containing 20 milligrams trenbolone acetate, and 1 
pellet containing 29 mg tylosin tartrate) per implant dose.
    (ii) Indications for use. For improved feed efficiency.
    (iii) Limitations. Implant subcutaneously in ear only. Do not use in 
animals intended for subsequent breeding or in dairy animals. Safety and 
effectiveness have not been established in veal calves. A withdrawal 
period has not been established for this product in preruminating 
calves. Do not use in calves to be processed for veal.
    (2) Heifers fed in confinement for slaughter--(i) Amount. Use last 
63 days prior to slaughter.
    (A) 200 mg trenbolone acetate (one implant consisting of 10 pellets, 
each pellet containing 20 mg trenbolone acetate) per implant dose.
    (B) 200 mg of trenbolone acetate (one implant consisting of 11 
pellets, each of 10 pellets containing 20 mg of trenbolone acetate, and 
1 pellet containing 29 mg of tylosin tartrate) per implant dose.
    (ii) Indications for use. For increased rate of weight gain and 
improved feed efficiency.
    (iii) Limitations. Implant subcutaneously in ear only. Do not use in 
animals intended for subsequent breeding or in dairy animals. Safety and 
effectiveness have not been established in veal calves. A withdrawal 
period has not been established for this product in preruminating 
calves. Do not use in calves to be processed for veal.

[66 FR 47961, Sept. 17, 2001, as amended at 69 FR 70056, Dec. 2, 2004; 
74 FR 61517, Nov. 25, 2009; 81 FR 48703, July 26, 2016]



Sec. 522.2477  Trenbolone acetate and estradiol.

    (a) [Reserved]

[[Page 343]]

    (b) Sponsors. See sponsors in Sec. 510.600(c) of this chapter for 
uses as in paragraph (d) of this section.
    (1) No. 058198 for use as in paragraphs (d)(1)(i)(A), (d)(1)(i)(B), 
(d)(1)(i)(C), (d)(1)(i)(D), (d)(1)(i)(E), (d)(1)(i)(F), (d)(1)(ii), 
(d)(1)(iii), (d)(2), and (d)(3) of this section.
    (2) No. 000061 for use as in paragraphs (d)(1)(i)(A), (d)(1)(i)(C), 
(d)(1)(i)(D), (d)(1)(i)(G), (d)(1)(ii), (d)(1)(iii), (d)(2)(i)(A), 
(d)(2)(i)(C), (d)(2)(i)(D), (d)(2)(ii), (d)(2)(iii), (d)(3)(i)(A), 
(d)(3)(ii), (d)(3)(iii), (d)(4), and (d)(5) of this section.
    (3) No. 054771 for use as in paragraphs (d)(1)(i)(A), (d)(1)(i)(D), 
(d)(1)(ii), (d)(1)(iii), (d)(3)(i)(A), (d)(3)(ii), and (d)(3)(iii) of 
this section.
    (c) Related tolerances. See Sec. Sec. 556.240 and 556.739 of this 
chapter.
    (d) Conditions of use--(1) Steers fed in confinement for slaughter--
(i) Amount. (A) 120 milligrams (mg) trenbolone acetate and 24 mg 
estradiol (one implant consisting of 6 pellets, each pellet containing 
20 mg trenbolone acetate and 4 mg estradiol) per implant dose.
    (B) 120 mg trenbolone acetate and 24 mg estradiol (one implant 
consisting of 7 pellets, each of 6 pellets containing 20 mg trenbolone 
acetate and 4 mg estradiol, and 1 pellet containing 29 mg tylosin 
tartrate) per implant dose.
    (C) 200 mg trenbolone acetate and 20 mg estradiol (one implant 
consisting of 10 pellets, each pellet containing 20 mg trenbolone 
acetate and 2 mg estradiol) per implant dose.
    (D) 80 mg trenbolone acetate and 16 mg estradiol (one implant 
consisting of 4 pellets, each pellet containing 20 mg trenbolone acetate 
and 4 mg estradiol) per implant dose.
    (E) 200 mg trenbolone acetate and 20 mg estradiol (one implant 
consisting of 11 pellets, each of 10 pellets containing 20 mg trenbolone 
acetate and 2 mg estradiol, and 1 pellet containing 29 mg tylosin 
tartrate) per implant dose.
    (F) 80 mg trenbolone acetate and 16 mg estradiol (one implant 
consisting of 5 pellets, each of 4 pellets containing 20 mg trenbolone 
acetate and 4 mg estradiol, and 1 pellet containing 29 mg tylosin 
tartrate) per implant dose.
    (G) 200 milligram (mg) trenbolone acetate and 40 mg estradiol (one 
implant consisting of 10 pellets, each pellet containing 20 mg 
trenbolone acetate and 4 mg estradiol) per implant dose.
    (ii) Indications for use. For increased rate of weight gain and 
improved feed efficiency.
    (iii) Limitations. Administer implant subcutaneously in the ear 
only. Do not use in animals intended for subsequent breeding or in dairy 
animals. Safety and effectiveness have not been established in veal 
calves. A withdrawal period has not been established for this product in 
preruminating calves. Do not use in calves to be processed for veal.
    (2) Heifers fed in confinement for slaughter--(i) Amount. (A) 140 mg 
trenbolone acetate and 14 mg estradiol (one implant consisting of 7 
pellets, each pellet containing 20 mg trenbolone acetate and 2 mg 
estradiol) per implant dose for use as in paragraph (d)(2)(ii)(A) of 
this section.
    (B) 140 mg trenbolone acetate and 14 mg estradiol (one implant 
consisting of 8 pellets, each of 7 pellets containing 20 mg trenbolone 
acetate and 2 mg estradiol, and 1 pellet containing 29 mg tylosin 
tartrate) per implant dose for use as in paragraphs (d)(2)(ii)(A) of 
this section.
    (C) 80 mg trenbolone acetate and 8 mg estradiol (one implant 
consisting of 4 pellets, each pellet containing 20 mg trenbolone acetate 
and 2 mg estradiol) per implant dose for use as in paragraph 
(d)(2)(ii)(B) of this section.
    (D) 200 mg trenbolone acetate and 20 mg estradiol (one implant 
consisting of 10 pellets, each pellet containing 20 mg trenbolone 
acetate and 2 mg estradiol) per implant dose for use as in paragraph 
(d)(2)(ii)(A) of this section.
    (E) 80 mg trenbolone acetate and 8 mg estradiol (one implant 
consisting of 5 pellets, each of 4 pellets containing 20 mg trenbolone 
acetate and 2 mg

estradiol, and 1 pellet containing 29 mg tylosin tartrate) per implant 
dose for use as in paragraph (d)(2)(ii)(B) of this section.
    (F) 200 mg trenbolone acetate and 20 mg estradiol (one implant 
consisting of 11 pellets, each of 10 pellets containing 20 mg trenbolone 
acetate and 2 mg estradiol, and 1 pellet containing 29 mg tylosin 
tartrate) per implant dose.

[[Page 344]]

    (ii) Indications for use. (A) For increased rate of weight gain and 
improved feed efficiency.
    (B) For increased rate of weight gain.
    (iii) Limitations. Administer implant subcutaneously in the ear 
only. Do not use in animals intended for subsequent breeding or in dairy 
animals. Safety and effectiveness have not been established in veal 
calves. A withdrawal period has not been established for this product in 
preruminating calves. Do not use in calves to be processed for veal.
    (3) Pasture cattle (slaughter, stocker, and feeder steers and 
heifers)--(i) Amount. (A) 40 mg trenbolone acetate and 8 mg estradiol 
(one implant consisting of 2 pellets, each pellet containing 20 mg 
trenbolone acetate and 4 mg estradiol) per implant dose.
    (B) 40 mg trenbolone acetate and 8 mg estradiol (one implant 
consisting of 3 pellets, each of 2 pellets containing 20 mg trenbolone 
acetate and 4 mg estradiol, and 1 pellet containing 29 mg tylosin 
tartrate) per implant dose.
    (ii) Indications for use. For increased rate of weight gain.
    (iii) Limitations. Administer implant subcutaneously in the ear 
only. Do not use in animals intended for subsequent breeding or in dairy 
animals. Safety and effectiveness have not been established in veal 
calves. A withdrawal period has not been established for this product in 
preruminating calves. Do not use in calves to be processed for veal.
    (4) Beef steers and heifers fed in confinement for slaughter--(i) 
Amount. Each extended- and delayed-release implant contains 200 mg 
trenbolone acetate and 20 mg estradiol (one implant consisting of 10 
pellets, each pellet containing 20 mg trenbolone acetate and 2 mg 
estradiol) per implant dose.
    (ii) Indications for use. For increased rate of weight gain and 
improved feed efficiency during 70 to 200 days after implantation.
    (iii) Limitations. Administer implant subcutaneously in the ear 
only. Do not use in lactating dairy cows or in animals intended for 
subsequent breeding. Use in these cattle may cause drug residues in milk 
and/or in calves born to these cows. Do not use in calves to be 
processed for veal. A withdrawal period has not been established for 
this product in pre-ruminating calves. Effectiveness and animal safety 
in veal calves have not been established. Not approved for repeated 
implantation (reimplantation) with this or any other cattle ear implant 
during the production phase(s) identified on labeling (beef steers and 
heifers fed in confinement for slaughter) unless otherwise indicated on 
labeling because safety and effectiveness have not been evaluated.
    (5) Beef heifers fed in confinement for slaughter--(i) Amount. Each 
extended-release implant contains 200 mg trenbolone acetate and 20 mg 
estradiol (one implant consisting of 6 coated and 4 uncoated pellets, 
each pellet containing 20 mg trenbolone acetate and 2 mg estradiol).
    (ii) Indications for use. For increased rate of weight gain and 
improved feed efficiency for up to 200 days after implantation.
    (iii) Limitations. Administer implant subcutaneously in the ear 
only. Do not use in lactating dairy cows or in animals intended for 
subsequent breeding. Use in these cattle may cause drug residues in milk 
and/or in calves born to these cows. Do not use in calves to be 
processed for veal. A withdrawal period has not been established for 
this product in pre-ruminating calves. Effectiveness and animal safety 
in veal calves have not been established. Not approved for repeated 
implantation (reimplantation) with this or any other cattle ear implant 
during the production phase(s) identified on labeling (beef heifers fed 
in confinement for slaughter) unless otherwise indicated on labeling 
because safety and effectiveness have not been evaluated.

[60 FR 4376, Jan. 23, 1995]

    Editorial Note: For Federal Register citations affecting Sec. 
522.2477, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and at www.govinfo.gov.



Sec. 522.2478  Trenbolone acetate and estradiol benzoate.

    (a) Specifications. (1) Each implant consists of:
    (i) 8 pellets, each pellet containing 25 milligrams (mg) trenbolone 
acetate and 3.5 mg estradiol benzoate.

[[Page 345]]

    (ii) 4 pellets, each pellet containing 25 mg trenbolone acetate and 
3.5 mg estradiol benzoate.
    (2) Each extended release implant consists of:
    (i) 8 pellets with a porous polymer film coating, each pellet 
containing 25 mg trenbolone acetate and 3.5 mg estradiol benzoate.
    (ii) 6 pellets with a porous polymer film coating, each pellet 
containing 25 mg trenbolone acetate and 3.5 mg estradiol benzoate.
    (b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
    (c) Related tolerances. See Sec. Sec. 556.240 and 556.739 of this 
chapter.
    (d) Conditions of use--(1) Steers fed in confinement for slaughter. 
(i) For an implant as described in paragraph (a)(1)(i) of this section:
    (A) Amount. 200 mg trenbolone acetate and 28 mg estradiol benzoate.
    (B) Indications for use. For increased rate of weight gain and 
improved feed efficiency.
    (C) Limitations. Implant subcutaneously in ear only. Safety and 
effectiveness have not been established in veal calves. A withdrawal 
period has not been established for this product in preruminating 
calves. Do not use in calves to be processed for veal.
    (ii) For an implant as described in paragraph (a)(1)(ii) of this 
section:
    (A) Amount. 100 mg trenbolone acetate and 14 mg estradiol benzoate.
    (B) Indications for use. For increased rate of weight gain.
    (C) Limitations. Implant subcutaneously in ear only. Safety and 
effectiveness have not been established in veal calves. A withdrawal 
period has not been established for this product in preruminating 
calves. Do not use in calves to be processed for veal.
    (iii) For an implant as described in paragraph (a)(2)(i) of this 
section:
    (A) Amount. 200 mg trenbolone acetate and 28 mg estradiol benzoate 
in an extended release implant.
    (B) Indications for use. For increased rate of weight gain and 
improved feed efficiency for up to 200 days.
    (C) Limitations. Implant subcutaneously in ear only. Safety and 
effectiveness have not been established in veal calves. A withdrawal 
period has not been established for this product in preruminating 
calves. Do not use in calves to be processed for veal.
    (2) Heifers fed in confinement for slaughter. (i) For an implant as 
described in paragraph (a)(1)(i) of this section:
    (A) Amount. 200 mg trenbolone acetate and 28 mg estradiol benzoate.
    (B) Indications for use. For increased rate of weight gain.
    (C) Limitations. Implant subcutaneously in ear only. Not for use in 
dairy or beef replacement heifers. Safety and effectiveness have not 
been established in veal calves. A withdrawal period has not been 
established for this product in preruminating calves. Do not use in 
calves to be processed for veal.
    (ii) For an implant as described in paragraph (a)(1)(ii) of this 
section:
    (A) Amount. 100 mg trenbolone acetate and 14 mg estradiol benzoate.
    (B) Indications for use. For increased rate of weight gain and 
improved feed efficiency.
    (C) Limitations. Implant subcutaneously in ear only. Not for use in 
dairy or beef replacement heifers. Safety and effectiveness have not 
been established in veal calves. A withdrawal period has not been 
established for this product in preruminating calves. Do not use in 
calves to be processed for veal.
    (iii) For an implant as described in paragraph (a)(2)(i) of this 
section:
    (A) Amount. 200 mg trenbolone acetate and 28 mg estradiol benzoate 
in an extended release implant.
    (B) Indications for use. For increased rate of weight gain and 
improved feed efficiency for up to 200 days.
    (C) Limitations. Implant subcutaneously in ear only. Not for use in 
dairy or beef replacement heifers. Safety and effectiveness have not 
been established in veal calves. A withdrawal period has not been 
established for this product in preruminating calves. Do not use in 
calves to be processed for veal.
    (3) Pasture steers and heifers (slaughter, stocker, and feeder). (i) 
For an implant as described in paragraph (a)(2)(ii) of this section:
    (A) Amount. 150 mg trenbolone acetate and 21 mg estradiol benzoate 
in an extended release implant.

[[Page 346]]

    (B) Indications for use. For increased rate of weight gain for up to 
200 days.
    (C) Limitations. Implant subcutaneously in ear only. Not for use in 
dairy or beef replacement heifers. Safety and effectiveness have not 
been established in veal calves. A withdrawal period has not been 
established for this product in preruminating calves. Do not use in 
calves to be processed for veal.
    (ii) [Reserved]

[67 FR 78972, Dec. 27, 2002, as amended at 69 FR 67818, Nov. 22, 2004; 
79 FR 16197, Mar. 25, 2014; 79 FR 64116, Oct. 28, 2014]



Sec. 522.2483  Triamcinolone.

    (a) Specifications. Each milliliter of suspension contains 2 or 6 
milligrams (mg) triamcinolone acetonide.
    (b) Sponsors. See Nos. 000010 and 069043 in Sec. 510.600(c) of this 
chapter.
    (c) Conditions of use--(1) Dogs and cats--(i) Amount--(A) 
Intramuscular or subcutaneous. For inflammatory, arthritic, or allergic 
disorders, administer 0.05 to 0.1 mg per pound (/lb) of body weight as a 
single injection. For dermatologic disorders, administer 0.1 mg per 
pound (/lb) of body weight as a single injection. If symptoms recur, the 
dose may be repeated, or oral corticosteroid therapy may be instituted.
    (B) Intralesional. Administer 1.2 to 1.8 mg, divided in several 
injections around the lesion, spaced 0.5 to 2.5 centimeters apart, 
depending on lesion size. At any one site, the dose injected should not 
exceed 0.6 mg. and should be well into the cutis to prevent rupture of 
the epidermis. When treating animals with multiple lesions, do not 
exceed a total dose of 6 mg.
    (C) Intra-articular and intrasynovial. Administer 1 to 3 mg as a 
single injection, depending on the size of the joint and severity of 
symptoms. After 3 or 4 days, repeat dosage if indicated. If initial 
results are inadequate or too transient, dosage may be increased, not to 
exceed 3 mg.
    (ii) Indications for use. For the treatment of inflammation and 
related disorders, and the management and treatment of acute arthritis 
and allergic and dermatologic disorders.
    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.
    (2) Horses--(i) Amount--(A) Intramuscular or subcutaneous. 
Administer 0.01 to 0.02 mg/lb of body weight as a single injection. 
Usual dose is 12 to 20 mg.
    (B) Intra-articular and intrasynovial. Administer 6 to 18 mg as a 
single injection, depending on the size of the joint and severity of 
symptoms. After 3 or 4 days, repeat dosage if indicated. If initial 
results are inadequate or too transient, dosage may be increased, not to 
exceed 18 mg.
    (ii) Indications for use. For the treatment of inflammation and 
related disorders.
    (iii) Limitations. Do not use in horses intended for human 
consumption. Federal law restricts this drug to use by or on the order 
of a licensed veterinarian.

[75 FR 10167, Mar. 5, 2010, as amended at 78 FR 21060, Apr. 9, 2013; 80 
FR 34279, June 16, 2015; 83 FR 48946, Sept. 28, 2018]



Sec. 522.2582  Triflupromazine.

    (a) Specifications. Each milliliter of solution contains 20 
milligrams (mg) of triflupromazine hydrochloride.
    (b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use--(1) Amount--(i) Dogs. Administer by 
intravenous injection at a dosage of 0.5 to 1 mg per pound of body 
weight daily, or by intramuscular injection at a dosage of 1 to 2 mg per 
pound of body weight daily.
    (ii) Cats. Administer by intramuscular injection at a dosage of 2 to 
4 mg per pound of body weight daily.
    (iii) Horses. Administer by intravenous or intramuscular injection 
at a dosage of 10 to 15 mg per 100 pounds of body weight daily to a 
maximum dose of 100 mg.
    (2) Indications for use. For use in dogs, cats, and horses to 
relieve anxiety and to help control psychomotor overactivity as well as 
to increase the tolerance of animals to pain and pruritus. The drug is 
indicated in various office and clinical procedures which require the 
aid of a tranquilizer, antiemetic, or preanesthetic.

[[Page 347]]

    (3) Limitations. Do not use in horses intended for human 
consumption. Federal law restricts this drug to use by or on the order 
of a licensed veterinarian.

[79 FR 16197, Mar. 25, 2014]



Sec. 522.2610  Trimethoprim and sulfadiazine.

    (a) Specifications. Each milliliter (mL) contains:
    (1) 40 milligrams (mg) trimethoprim suspended in a solution 
containing 200 mg sulfadiazine; or
    (2) 80 mg trimethoprim suspended in a solution containing 400 mg 
sulfadiazine (as the sodium salt).
    (b) Sponsors. See Nos. 000061 and 054771 in Sec. 510.600(c) of this 
chapter.
    (c) Conditions of use--(1) Dogs--(i) Amount. 1 mL of the product 
described in paragraph (a)(1) of this section (40 mg trimethoprim and 
200 mg sulfadiazine) per 20 pounds (9 kilograms) of body weight per day 
by subcutaneous injection.
    (ii) Indications for use. For the treatment of acute urinary tract 
infections, acute bacterial complications of distemper, acute 
respiratory tract infections, acute alimentary tract infections, and 
acute septicemia due to Streptococcus zooepidemicus.
    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.
    (2) Horses--(i) Amount. 2 mL of the product described in paragraph 
(a)(2) of this section (160 mg trimethoprim and 800 mg sulfadiazine) per 
100 pounds (45 kilograms) of body weight per day by intravenous 
injection as single, daily dose for 5 to 7 days. The daily dose may also 
be halved and given morning and evening.
    (ii) Indications for use. For use where systemic antibacterial 
action against sensitive organisms is required during treatment of acute 
strangles, respiratory tract infections, acute urogenital infections, 
and wound infections and abscesses.
    (iii) Limitations. Do not use in horses intended for human 
consumption. Federal law restricts this drug to use by or on the order 
of a licensed veterinarian.

[71 FR 30803, May 31, 2006, as amended at 79 FR 16197, Mar. 25, 2014]



Sec. 522.2615  Tripelennamine.

    (a) Specifications. Each milliliter of solution contains 20 
milligrams (mg) of tripelennamine hydrochloride.
    (b) Sponsors. See Nos. 016592 and 051031 in Sec. 510.600(c) of this 
chapter.
    (c) Related tolerances. See Sec. 556.741 of this chapter.
    (d) Conditions of use--(1) Dogs and cats--(i) Amount. Administer 0.5 
mg per pound of body weight by intramuscular injection.
    (ii) Indications for use. For use in treating conditions in which 
antihistaminic therapy may be expected to lead to alleviation of some 
signs of disease.
    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.
    (2) Horses--(i) Amount. Administer 0.5 mg per pound of body weight 
by intramuscular injection.
    (ii) Indications for use. For use in treating conditions in which 
antihistaminic therapy may be expected to lead to alleviation of some 
signs of disease.
    (iii) Limitations. Do not use in horses intended for human 
consumption. Federal law restricts this drug to use by or on the order 
of a licensed veterinarian.
    (3) Cattle--(i) Amount. Administer 0.5 mg per pound of body weight 
by intravenous or intramuscular injection.
    (ii) Indications for use. For use in treating conditions in which 
antihistaminic therapy may be expected to lead to alleviation of some 
signs of disease.
    (iii) Limitations. Treated cattle must not be slaughtered for food 
during treatment and for 4 days following the last treatment. Milk that 
has been taken during treatment and for 24 hours (two milkings) after 
the last treatment must not be used for food. A withdrawal period has 
not been established for this product in preruminating calves. Do not 
use in calves to be processed for veal. Federal law restricts this drug 
to use by or on the order of a licensed veterinarian.

[51 FR 44450, Dec. 10, 1986, as amended at 61 FR 29480, June 11, 1996; 
62 FR 4164, Jan. 29, 1997; 78 FR 17597, Mar. 22, 2013; 79 FR 16198, Mar. 
25, 2014; 81 FR 22524, Apr. 18, 2016; 82 FR 11508, Feb. 24, 2017]

[[Page 348]]



Sec. 522.2630  Tulathromycin.

    (a) Specifications. Each milliliter of solution contains:
    (1) 100 milligrams (mg) tulathromycin
    (2) 25 mg tulathromycin
    (b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter for 
use as in paragraph (d) of this section:
    (1) Product described as in paragraph (a)(1) of this section for use 
as in paragraphs (d)(1)(i), (d)(1)(ii), (d)(1)(iii)(A), and (d)(2) of 
this section.
    (2) Product described as in paragraph (a)(2) of this section for use 
as in paragraphs (d)(1)(i), (d)(1)(ii)(B), (d)(1)(iii)(B), and (d)(2) of 
this section.
    (c) Related tolerances. See Sec. 556.745 of this chapter.
    (d) Conditions of use--(1) Cattle--(i) Amount. 2.5 mg per kilogram 
(/kg) body weight as a single subcutaneous injection in the neck.
    (ii) Indications for use--(A) Beef and non-lactating dairy cattle. 
For the treatment of bovine respiratory disease (BRD) associated with 
Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and 
Mycoplasma bovis. For the control of respiratory disease in cattle at 
high risk of developing BRD associated with M. haemolytica, P. 
multocida, H. somni, and M. bovis. For the treatment of infectious 
bovine keratoconjunctivitis (IBK) associated with Moraxella bovis. For 
the treatment of bovine foot rot (interdigital necrobacillosis) 
associated with Fusobacterium necrophorum and Porphyromonas levii.
    (B) Suckling calves, dairy calves, and veal calves. For the 
treatment of bovine respiratory disease (BRD) associated with Mannheimia 
haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma 
bovis.
    (iii) Limitations. (A) Cattle intended for human consumption must 
not be slaughtered within 18 days from the last treatment. This drug is 
not approved for use in female dairy cattle 20 months of age or older, 
including dry dairy cows. Use in these cattle may cause drug residues in 
milk and/or in calves born to these cows. Federal law restricts this 
drug to use by or on the order of a licensed veterinarian.
    (B) Calves intended for human consumption must not be slaughtered 
within 22 days from the last treatment. Not for use in ruminating 
cattle. Federal law restricts this drug to use by or on the order of a 
licensed veterinarian.
    (2) Swine--(i) Amount. 2.5 mg/kg body weight as a single 
intramuscular injection in the neck.
    (ii) Indications for use. For the treatment of swine respiratory 
disease (SRD) associated with Actinobacillus pleuropneumoniae, P. 
multocida, Bordetella bronchiseptica, Haemophilus parasuis, and 
Mycoplasma hyopneumoniae; and for the control of SRD associated with A. 
pleuropneumoniae, P. multocida, and M. hyopneumoniae in groups of pigs 
where SRD has been diagnosed.
    (iii) Limitations. Swine intended for human consumption must not be 
slaughtered within 5 days from the last treatment. Federal law restricts 
this drug to use by or on the order of a licensed veterinarian.

[70 FR 39918, July 12, 2005, as amended at 71 FR 57416, Sept. 29, 2006; 
72 FR 54540, Sept. 26, 2007; 73 FR 6018, Feb. 1, 2008; 73 FR 58872, Oct. 
8, 2008; 74 FR 53165, Oct. 16, 2009; 78 FR 63872, Oct. 25, 2013; 79 FR 
74020, Dec. 15, 2014; 80 FR 13230, Mar. 13, 2015; 81 FR 67151, Sept. 30, 
2016]



Sec. 522.2640  Tylosin.

    (a) Specifications. Each milliliter (mL) of solution contains 50 or 
200 milligrams (mg) of tylosin activity (as tylosin base).
    (b) Sponsors. See sponsors in Sec. 510.600(c) of this chapter as 
follows:
    (1) No. 000986 for use of 50- or 200-mg/mL solutions as in paragraph 
(e) of this section.
    (2) Nos. 000010 and 061133 for use of a 200-mg/mL solution as in 
paragraphs (e)(1) and (2) of this section.
    (c) Related tolerances. See Sec. 556.746 of this chapter.
    (d) Special considerations. Labeling must bear the warning 
statements: ``Do not administer to horses or other equines. Injection of 
tylosin in equines has been fatal.''
    (e) Conditions of use--(1) Beef cattle and nonlactating dairy 
cattle--(i) Amount. Administer 8 mg per pound (mg/lb) of body weight by 
intramuscular injection once daily for not more than 5 consecutive days. 
Continue treatment 24 hours after symptoms disappear.

[[Page 349]]

    (ii) Indications for use. Treatment of bovine respiratory complex 
(shipping fever, pneumonia) usually associated with Pasteurella 
multocida and Arcanobacterium pyogenes; foot rot (necrotic 
pododermatitis) and calf diphtheria caused by Fusobacterium necrophorum 
and metritis caused by A. pyogenes.
    (iii) Limitations. Do not inject more than 10 mL per site. Use a 50-
mg/mL solution for calves weighing less than 200 pounds. Cattle intended 
for human consumption must not be slaughtered within 21 days of the last 
use of this drug product. This drug product is not approved for use in 
female dairy cattle 20 months of age or older, including dry dairy cows. 
Use in these cattle may cause drug residues in milk and/or in calves 
born to these cows. This product is not approved for use in calves 
intended to be processed for veal. A withdrawal period has not been 
established in preruminating calves.
    (2) Swine--(i) Amount. Administer 4 mg/lb of body weight by 
intramuscular injection twice daily for not more than 3 consecutive 
days. Continue treatment 24 hours after symptoms disappear. If tylosin 
medicated drinking water is used as a followup treatment for swine 
dysentery, the animal should thereafter receive feed containing 40 to 
100 grams of tylosin per ton for 2 weeks to assure depletion of tissue 
residues.
    (ii) Indications for use. Treatment of swine arthritis caused by 
Mycoplasma hyosynoviae; swine pneumonia caused by Pasteurella spp.; 
swine erysipelas caused by Erysipelothrix rhusiopathiae; swine dysentery 
associated with Treponema hyodysenteriae when followed by appropriate 
medication in the drinking water and/or feed.
    (iii) Limitations. Do not inject more than 5 mL per site. Adverse 
reactions, including shock and death may result from overdosage in baby 
pigs. It is recommended that tylosin 50-mg/mL injection be used in pigs 
weighing less than 25 lbs. Swine intended for human consumption must not 
be slaughtered within 14 days of the last use of this drug product.
    (3) Dogs and cats--(i) Amount. Administer 3 to 5 mg/lb of body 
weight by intramuscular injection at 12- to 24-hour intervals.
    (ii) Indications for use--(A) Dogs. Treatment of upper respiratory 
infections such as bronchitis, tracheobronchitis, tracheitis, 
laryngitis, tonsillitis, and pneumonia caused by Staphylococci spp., 
hemolytic Streptococci spp., and Pasteurella multocida.
    (B) Cats. Treatment of upper respiratory infections when caused by 
Staphylococci spp. and hemolytic Streptococci spp. and for feline 
pneumonitis when caused by tylosin-susceptible organisms.
    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

[81 FR 67151, Sept. 30, 2016, as amended at 84 FR 8974, Mar. 13, 2019; 
84 FR 32992, July 11, 2019]



Sec. 522.2662  Xylazine.

    (a) Specifications. Each milliliter (mL) of solution contains 
xylazine hydrochloride equivalent to:
    (1) 20 milligrams (mg) xylazine.
    (2) 100 mg xylazine.
    (3) 300 mg xylazine.
    (b) Sponsors. See sponsors in Sec. 510.600(c) of this chapter for 
uses as in paragraph (d) of this section.
    (1) No. 069043 for use of product described in paragraph (a)(2) of 
this section as in paragraph (d)(2) of this section.
    (2) Nos. 000010 and 061133 for use of product described in paragraph 
(a)(2) of this section as in paragraphs (d)(2), (d)(3)(i), 
(d)(3)(ii)(A), and (d)(3)(iii) of this section.
    (3) Nos. 058198 and 061651 for use of product described in paragraph 
(a)(1) of this section as in paragraph (d)(1) of this section; and 
product described in paragraph (a)(2) of this section as in paragraphs 
(d)(2), (d)(3)(i), (d)(3)(ii)(A), and (d)(3)(iii) of this section.
    (4) No. 059399 for use of product described in paragraph (a)(1) of 
this section as in paragraph (d)(1) of this section; product described 
in paragraph (a)(2) of this section as in paragraphs (d)(2), (d)(3)(i), 
(d)(3)(ii)(A), and (d)(3)(iii) of this section; and product described in 
paragraph (a)(3) of this section as in paragraphs (d)(3)(i), 
(d)(3)(ii)(B), and (d)(3)(iii) of this section.

[[Page 350]]

    (c) Special considerations. Federal law restricts this drug to use 
by or on the order of a licensed veterinarian.
    (d) Conditions of use--(1) Dogs and cats--(i) Amount. 0.5 mg/pound 
(lb) intravenously or 1.0 mg/lb subcutaneously.
    (ii) Indications for use. To produce sedation, as an analgesic, and 
as a preanesthetic to local or general anesthesia.
    (2) Horses--(i) Amount. 0.5 mg/lb intravenously or 1.0 mg/lb 
intramuscularly.
    (ii) Indications for use. To produce sedation, as an analgesic, and 
as a preanesthetic to local or general anesthesia.
    (iii) Limitations. Do not use in horses intended for human 
consumption.
    (3) Elk and deer--(i) Amount. Administer intramuscularly, by hand 
syringe, or by syringe dart, in the heavy muscles of the croup or 
shoulder as follows:
    (A) Elk (Cervus canadensis): 0.25 to 0.5 mg/lb.
    (B) Mule deer (Odocoileus hemionus), sika deer (Cervus nippon), and 
white-tailed deer (Odocoileus virginianus): 1 to 2 mg/lb.
    (C) Fallow deer (Dama dama): 2 to 4 mg/lb.
    (ii) Indications for use. (A) To produce sedation, as an analgesic, 
and as a preanesthetic to local anesthesia.
    (B) To produce sedation, accompanied by a shorter period of 
analgesia. May be used to calm and facilitate handling of fractious 
animals for diagnostic procedures, for minor surgical procedures, for 
therapeutic medication for sedation and relief of pain following injury 
or surgery, and as a preanesthetic to local anesthetic. At the 
recommended dosages, can be used in conjunction with local anesthetics, 
such as procaine or lidocaine.
    (iii) Limitations. Do not use in domestic food-producing animals. Do 
not use in Cervidae less than 15 days before or during the hunting 
season.

[68 FR 26206, May 15, 2003, as amended at 75 FR 10167, Mar. 5, 2010, 78 
FR 21060, Apr. 9, 2013; 79 FR 16198, Mar. 25, 2014; 79 FR 21127, Apr. 
15, 2014; 79 FR 74020, Dec. 15, 2014; 80 FR 13230, Mar. 13, 2015; 83 FR 
48946, Sept. 28, 2018; 84 FR 8974, Mar. 13, 2019; 86 FR 14820, Mar. 19, 
2021]



Sec. 522.2670  Yohimbine.

    (a) Specifications. Each milliliter (mL) of solution contains 2 or 5 
milligrams (mg) of yohimbine (as hydrochloride).
    (b) Sponsors. See sponsors in Sec. 510.600(c) of this chapter for 
use as in paragraph (c) of this section.
    (1) No. 059399 for use of in 2 mg/mL solution as in paragraph (c)(1) 
of this section.
    (2) No. 053923 for use of in 5 mg/mL solution as in paragraph (c)(2) 
of this section.
    (c) Conditions of use--(1) Dogs--(i) Amount. Administer 0.05 mg per 
pound (0.11 mg per kilogram) of body weight by intravenous injection.
    (ii) Indications for use. To reverse the effects of xylazine in 
dogs.
    (iii) Limitations. Not for use in food-producing animals. Federal 
law restricts this drug to use by or on the order of a licensed 
veterinarian.
    (2) Deer and elk--(i) Amount. Administer 0.2 to 0.3 mg per kilogram 
of body weight by intravenous injection.
    (ii) Indications for use. A s an antagonist to xylazine sedation in 
free ranging or confined members of the family Cervidae (deer and elk).
    (iii) Limitations. Do not use in domestic food-producing animals. Do 
not use for 30 days before or during hunting season. Federal law 
restricts this drug to use by or on the order of a licensed 
veterinarian.

[79 FR 74020, Dec. 15, 2014, as amended at 80 FR 13230, Mar. 13, 2015]



Sec. 522.2680  Zeranol.

    (a) Specifications. Each pellet contains 12, 18, or 20 milligrams 
(mg) zeranol.
    (b) Sponsor. See 000061 in Sec. 510.600(c) of this chapter.
    (c) Related tolerances. See Sec. 556.760 of this chapter.
    (d) Conditions of use--(1) Beef cattle--(i) Amount. 36 mg zeranol 
(one implant consisting of 3 pellets, each pellet containing 12 mg 
zeranol) per implant dose.
    (ii) Indications for use. (A) For increased rate of weight gain and 
improved feed conversion in weaned beef calves, growing beef cattle, 
feedlot steers, and feedlot heifers.

[[Page 351]]

    (B) For increased rate of weight gain in suckling calves.
    (iii) Limitations. Implant subcutaneously in ear only. Do not use in 
bulls intended for reproduction or in dairy animals. Do not use before 1 
month of age or after weaning in heifers intended for reproduction. 
Safety and effectiveness have not been established in veal calves. A 
withdrawal period has not been established for this product in 
preruminating calves. Do not use in calves to be processed for veal.
    (2) Feedlot lambs--(i) Amount. 12 mg zeranol (one implant consisting 
of 1 pellet containing 12 mg zeranol) per implant dose.
    (ii) Indications for use. For increased rate of weight gain and 
improved feed conversion.
    (iii) Limitations. Implant subcutaneously in ear only. Do not use in 
breeding animals. Do not implant animals within 40 days of slaughter. 
Safety and effectiveness have not been established in veal calves. A 
withdrawal period has not been established for this product in 
preruminating calves. Do not use in calves to be processed for veal.
    (3) Steers fed in confinement for slaughter--(i) Amount. 72 mg 
zeranol (one implant consisting of 6 pellets, each pellet containing 12 
mg zeranol) per implant dose.
    (ii) Indications for use. For increased rate of weight gain and 
improved feed efficiency.
    (iii) Limitations. Implant subcutaneously in ear only. Safety and 
effectiveness have not been established in veal calves. A withdrawal 
period has not been established for this product in preruminating 
calves. Do not use in calves to be processed for veal.
    (4) Pasture cattle (slaughter, stocker, feeder steers, and 
heifers)--(i) Amount. 138 mg zeranol (one implant consisting of 7 
pellets, each of 6 pellets containing 20 mg zeranol and a seventh pellet 
containing 18 mg zeranol) per implant dose.
    (ii) Indications for use. For increased rate of weight gain.
    (iii) Limitations. Implant subcutaneously in ear only. Safety and 
effectiveness have not been established in veal calves. A withdrawal 
period has not been established for this product in preruminating 
calves. Do not use in calves to be processed for veal.

[59 FR 19639, Apr. 25, 1994; 60 FR 26360, May 17, 1995, as amended at 62 
FR 61625, Nov. 19, 1997; 64 FR 46840, Aug. 27, 1999; 67 FR 6867, Feb. 
14, 2002; 70 FR 6764, Feb. 9, 2005]



Sec. 522.2690  Zinc gluconate.

    (a) Specifications. Each milliliter of solution contains 13.1 
milligrams zinc as zinc gluconate neutralized to pH 7.0 with L-arginine.
    (b) Sponsor. See No. 076175 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in dogs--(1) Amount. The volume injected into 
each testicle is based on testicular width as determined by measuring 
each testicle at its widest point using a metric scale (millimeter) 
caliper.
    (2) Indications for use. Intratesticular injection for chemical 
sterilization of 3- to 10-month-old male dogs.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[68 FR 26995, May 19, 2003, as amended at 76 FR 79064, Dec. 21, 2011]



PART 524_OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS--
Table of Contents



Sec.
524.86 Amitraz.
524.154 Bacitracin, neomycin, and polymyxin B ophthalmic ointment.
524.155 Bacitracin, neomycin, polymyxin B, and hydrocortisone ophthalmic 
          ointment.
524.390 Chloramphenicol ophthalmic ointment.
524.402 Chlorhexidine.
524.450 Clotrimazole.
524.463 Copper naphthenate.
524.575 Cyclosporine ophthalmic ointment.
524.590 Diclofenac.
524.660 Dimethyl sulfoxide.
524.770 Doramectin.
524.775 Emodepside and praziquantel.
524.802 Enrofloxacin and silver sulfadiazine otic emulsion.
524.814 Eprinomectin.
524.815 Eprinomectin and praziquantel.
524.900 Famphur.
524.920 Fenthion.
524.955 Florfenicol, terbinafine, and betamethasone acetate otic gel.
524.957 Florfenicol, terbinafine, and mometasone otic solution.

[[Page 352]]

524.960 Flumethasone, neomycin, and polymyxin B ophthalmic solution.
524.970 Flunixin.

               Fluocinolone Topical and Otic Dosage Forms

524.981 [Reserved]
524.981a Fluocinolone cream.
524.981b Fluocinolone solution.
524.981c Fluocinolone and neomycin cream.
524.981d Fluocinolone and dimethyl sulfoxide solution.
524.981e Fluocinolone and dimethyl sulfoxide otic solution.
524.998 Fluralaner.
524.1001 Furalaner and moxidectin.
524.1005 Furazolidone powder.
524.1044 Gentamicin sophthalmic and topical dosage forms.
524.1044a Gentamicin ophthalmic solution.
524.1044b Gentamicin and betamethasone otic solution.
524.1044c Gentamicin ophthalmic ointment.
524.1044d Gentamicin and betamethasone ointment.
524.1044e Gentamicin spray.
524.1044f Gentamicinand betamethasone spray.
524.1044g Gentamicin, betamethasone, and clotrimazole ointment.
524.1044h Gentamicin, mometasone, and clotrimazole otic suspension.
524.1044i Gentamicin and betamethasone ophthalmic solution.
524.1132 Hydrocortisone, miconazole, and gentamicin otic suspension.
524.1140 Imidacloprid and ivermectin.
524.1146 Imidacloprid and moxidectin.
524.1193 Ivermectin topical solution.
524.1195 Ivermectin otic suspension.
524.1200 Kanamycin ophthalmic and topical dosage forms.
524.1200a Kanamycin ophthalmic ointment.
524.1200b Kanamycin ophthalmic solution.
524.1204 Kanamycin, amphomycin, and hydrocortisone ointment.
524.1240 Levamisole.
524.1376 2-Mercaptobenzothiazole solution.
524.1443 Miconazole.
524.1445 Miconazole, polymixin B, and prednisolone suspension.
524.1446 Milbemycin otic solution.
524.1448 Mirtazapine transdermal ointment.
524.1450 Moxidectin.
524.1465 Mupirocin.
524.1484 Neomycin ophthalmic and topical dosage forms.
524.1484b Neomycin, isoflupredone, and tetracaine powder.
524.1484c Neomycin, isoflupredone, and tetracaine ointment.
524.1484d Neomycin, hydrocortisone, and tetracaine otic ointment.
524.1484e Neomycin and polymyxin B ophthalmic solution.
524.1484f Neomycin, prednisolone, and tetracaine otic suspension.
524.1484g Neomycin, thiabendazole, and dexamethasone solution.
524.1484h Neomycin, penicillin, polymyxin B, and hydrocortisone 
          suspension.
524.1484i Neomycin and hydrocortisone ointment.
524.1484j Neomycin and prednisolone ophthalmic ointment.
524.1484k Neomycin and prednisolone suspension.
524.1580 Nitrofurazone topical dosage forms.
524.1580a Nitrofurazone ointment.
524.1580b Nitrofurazone soluble powder.
524.1580c Nitrofurazone and butacaine ointment.
524.1600 Nystatin ophthalmic and topical dosage forms.
524.1600a Nystatin, neomycin, thiostrepton, and triamcinolone ointment.
524.1600b Nystatin, neomycin, thiostrepton, and triamcinolone ophthalmic 
          ointment
524.1610 Orbifloxacin, mometasone furoate monohydrate, and posaconazole 
          suspension.
524.1662 Oxytetracycline ophthalmic and topical dosage forms.
524.1662a Oxytetracycline and hydrocortisone spray.
524.1662b Oxytetracycline and polymyxin B ophthalmic ointment.
524.1742 Phosmet emulsifiable liquid.
524.1982 Proparacaine ophthalmic solution.
524.2080 Ropinirole.
524.2098 Selamectin.
524.2099 Selamectin and sarolaner.
524.2101 Selenium disulfide suspension.
524.2350 Tolnaftate cream.
524.2482 Triamcinolone spray.
524.2483 Triamcinolone cream.
524.2620 Liquid crystalline trypsin, Peru balsam, castor oil.

    Authority: 21 U.S.C. 360b.

    Source: 40 FR 13873, Mar. 27, 1975, unless otherwise noted.



Sec. 524.86  Amitraz.

    (a) Specifications. Amitraz liquid contains 19.9 percent amitraz in 
an organic solvent.
    (b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use--(1) Indications for use. For dogs for the 
treatment of generalized demodicosis (Demodex canis).
    (2) Amount. One 10.6 milliliter bottle per 2 gallons of warm water 
(250 parts per million) for each treatment, for a total of 3 to 6 
treatments, 14 days apart.

[[Page 353]]

    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[47 FR 18589, Apr. 30, 1982, as amended at 79 FR 10967, Feb. 27, 2014]



Sec. 524.154  Bacitracin, neomycin, and polymyxin B ophthalmic ointment.

    (a) Specifications. Each gram of ointment contains:
    (1) 500 units bacitracin, 3.5 milligrams (mg) neomycin sulfate 
(equivalent to 3.5 mg neomycin base), and 10,000 units polymyxin B 
sulfate; or
    (2) 400 units bacitracin zinc, 5 mg neomycin sulfate (equivalent to 
3.5 mg neomycin base), and 10,000 units polymyxin B sulfate.
    (b) Sponsors. See sponsor numbers in Sec. 510.600(c) of this 
chapter as follows:
    (1) No. 054771 for use of product described in paragraph (a)(1) as 
in paragraph (c) of this section.
    (2) Nos. 000061, 043264, and 059399 for use of product described in 
paragraph (a)(2) as in paragraph (c) of this section.
    (c) Conditions of use in dogs and cats--(1) Amount. Apply a thin 
film over the cornea 3 or 4 times daily.
    (2) Indications for use. Treatment of superficial bacterial 
infections of the eyelid and conjunctiva of dogs and cats when due to 
susceptible organisms.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[57 FR 37333, Aug. 18, 1992, as amended at 61 FR 8873, Mar. 6, 1996; 62 
FR 61625, Nov. 19, 1997; 77 FR 64717, Oct. 23, 2012; 79 FR 10967, Feb. 
27, 2014; 80 FR 61297, Oct. 13, 2015]



Sec. 524.155  Bacitracin, neomycin, polymyxin B, and hydrocortisone 
ophthalmic ointment.

    (a) Specifications. Each gram of ointment contains 400 units of 
bacitracin zinc, 5 milligrams (mg) of neomycin sulfate (equivalent to 
3.5 mg of neomycin sulfate), 10,000 units of polymyxin B sulfate, and10 
mg of hydrocortisone.
    (b) Sponsors. See Nos. 000061 and 043264 in Sec. 510.600(c) of this 
chapter.
    (c) Conditions of use in dogs and cats--(1) Amount. Apply a thin 
film over the cornea three or four times daily.
    (2) Indications for use. For treating acute or chronic 
conjunctivitis caused by susceptible organisms.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[57 FR 37333, Aug. 18, 1992, as amended at 61 FR 8873, Mar. 6, 1996; 62 
FR 61626, Nov. 19, 1997; 77 FR 64717, Oct. 23, 2012; 79 FR 10967, Feb. 
27, 2014]



Sec. 524.390  Chloramphenicol ophthalmic ointment.

    (a) Specifications. Each gram contains 10 milligrams 
chloramphenicol.
    (b) Sponsors. See Nos. 043264 and 054771 in Sec. 510.600(c) of this 
chapter.
    (c) Conditions of use in dogs and cats--(1) Amount. Apply every 3 
hours around the clock for 48 hours, after which night instillations may 
be omitted.
    (2) Indications for use. For treatment of bacterial conjunctivitis 
caused by pathogens susceptible to chloramphenicol.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian. Federal law prohibits the use of this 
drug in food-producing animals.

[77 FR 4897, Feb. 1, 2012, as amended at 77 FR 64717, Oct. 23, 2012; 79 
FR 10967, Feb. 27, 2014]



Sec. 524.402  Chlorhexidine.

    (a) Specifications. Each gram of ointment contains 10 milligrams 
chlorhexidine acetate.
    (b) Sponsors. See Nos. 054771 and 058829 in Sec. 510.600(c) of this 
chapter.
    (c) Conditions of use in dogs, cats, and horses--(1) Indications for 
use. For use as a topical antiseptic ointment for surface wounds.
    (2) Limitations. Do not use in horses intended for human 
consumption.

[72 FR 265, Jan. 4, 2007, as amended at 79 FR 10967, Feb. 27, 2014]



Sec. 524.450  Clotrimazole.

    (a) Specifications. Each gram of cream contains 10 milligrams of 
clotrimazole.
    (b) Sponsor. See No. 058198 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use--(1) Amount. Apply \1/4\-inch ribbon of cream 
per square inch of lesion once daily for 2 to 4 weeks.
    (2) Indications of use. For the treatment of fungal infections of 
dogs and cats caused by Microsporum canis and Trichophyton 
mentagrophytes.

[[Page 354]]

    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[40 FR 48128, July 18, 1980, as amended at 79 FR 10967, Feb. 27, 2014; 
86 FR 14820, Mar. 19, 2021]



Sec. 524.463  Copper naphthenate.

    (a) Amount. The drug is a 37.5 percent solution of copper 
naphthenate.
    (b) Sponsors. See Nos. 017135, 054771, and 058829 in Sec. 
510.600(c) of this chapter.
    (c) Conditions of use in horses--(1) Amount. Apply daily to affected 
hooves until fully healed.
    (2) Indications for use. As an aid in treating horses and ponies for 
thrush caused by organisms susceptible to copper naphthenate.
    (3) Limitations. Use on horses and ponies only. Avoid contact around 
eyes. Do not contaminate feed. Do not use in horses intended for human 
consumption.

[47 FR 4250, Jan. 29, 1982, as amended at 68 FR 55825, Sept. 29, 2003; 
71 FR 38074, July 5, 2006; 79 FR 10967, Feb. 27, 2014]



Sec. 524.575  Cyclosporine ophthalmic ointment.

    (a) Specifications. Each gram of ointment contains 2 milligrams of 
cyclosporine.
    (b) Sponsor. See No. 000061 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use--(1) Amount. Apply a \1/4\-inch strip of 
ointment directly on the cornea or into the conjunctival sac of the 
affected eye(s) every 12 hours.
    (2) Indications for use. For management of chronic 
keratoconjunctivitis sicca (KCS) and chronic superficial keratitis (CSK) 
in dogs.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[60 FR 48651, Sept. 20, 1995, as amended at 62 FR 48940, Sept. 18, 1997; 
79 FR 10967, Feb. 27, 2014]



Sec. 524.590  Diclofenac.

    (a) Specifications. Each gram of cream contains 10 milligrams 
diclofenac sodium.
    (b) Sponsor. See No. 000010 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in horses--(1) Amount. Apply a 5-inch 
(5) ribbon of cream twice daily over the affected joint for 
up to 10 days and rub thoroughly into the hair covering the joint until 
it disappears.
    (2) Indications for use in horses. For the control of pain and 
inflammation associated with osteoarthritis in tarsal, carpal, 
metacarpophalangeal, metatarsophalangeal, and proximal interphalangeal 
(hock, knee, fetlock and pastern) joints.
    (3) Limitations. Do not use in horses intended for human 
consumption. Federal law restricts this drug to use by or on the order 
of a licensed veterinarian.

[69 FR 40767, July 7, 2004, as amended at 74 FR 26782, June 4, 2009; 74 
FR 47436, Sept. 16, 2009]



Sec. 524.660  Dimethyl sulfoxide.

    (a) Specifications. (1) Each milliliter (mL) of solution contains 90 
percent dimethyl sulfoxide and 10 percent water.
    (2) Each milliliter (mL) of gel product contains 90 percent dimethyl 
sulfoxide.
    (b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in horses and dogs--(1) Amount--(i) Horses. 
Apply topically two to three times daily in an amount not to exceed 100 
mL per day. Total duration of therapy should not exceed 30 days.
    (ii) Dogs. Apply topically three to four times daily in an amount 
not to exceed 20 mL per day. Total duration of therapy should not exceed 
14 days.
    (2) Indications for use. To reduce acute swelling due to trauma.
    (3) Limitations. Do not use in horses intended for human 
consumption. Federal law restricts this drug to use by or on the order 
of a licensed veterinarian.

[79 FR 10967, Feb. 27, 2014]



Sec. 524.770  Doramectin.

    (a) Specifications. Each milliliter (mL) of solution contains 5 
milligrams (mg) doramectin.
    (b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
    (c) Related tolerances. See Sec. 556.222 of this chapter.
    (d) Special considerations. See Sec. 500.25 of this chapter.

[[Page 355]]

    (e) Conditions of use in cattle--(1) Amount. Administer topically as 
a single dose 0.5 mg (1 mL) per kilogram (1 mL per 22 pounds) body 
weight.
    (2) Indications for use. For treatment and control of 
gastrointestinal roundworms: Ostertagia ostertagi (adults and fourth-
stage larvae), Ostertagia ostertagi (inhibited fourth-stage larvae), 
Ostertagia lyrata (adults), Haemonchus placei (adults and fourth-stage 
larvae), Trichostrongylus axei (adults and fourth-stage larvae), 
Trichostrongylus colubriformis (adults and fourth-stage larvae), 
Cooperia oncophora (adults and fourth-stage larvae), Cooperia punctata 
(adults and fourth-stage larvae), Cooperia pectinata (adults), Cooperia 
surnabada (adults), Bunostomum phlebotomum (adults), Oesophagostomum 
radiatum (adults and fourth-stage larvae), Trichuris spp. (adults); 
lungworms: Dictyocaulus viviparus (adults and fourth-stage larvae); 
eyeworms: Thelazia gulosa (adults), Thelazia skrjabini (adults); grubs: 
Hypoderma bovis and Hypoderma lineatum; sucking lice: Linognathus 
vituli, Haematopinus eurysternus, and Solenopotes capillatus; biting 
lice: Bovicola (Damalinia) bovis; mange mites: Chorioptes bovis and 
Sarcoptes scabiei; horn flies: Haematobia irritans; and to control 
infections and to protect from reinfection with Cooperia oncophora, 
Dictyocaulus viviparus, Ostertagia ostertagi, and Oesophagostomum 
radiatum for 28 days; and with Cooperia punctata and Haemonchus placei 
for 35 days after treatment; and to control infestations and to protect 
from reinfestation with Linognathus vituli for 42 days and with Bovicola 
(Damalinia) bovis for 77 days after treatment.
    (3) Limitations. Do not slaughter cattle within 45 days of latest 
treatment. This product is not approved for use in female dairy cattle 
20 months of age or older, including dry dairy cows. Use in these cattle 
may cause drug residues in milk and/or in calves born to these cows. A 
withdrawal period has not been established for this product in 
preruminating calves. Do not use in calves to be processed for veal.

[69 FR 48392, Aug. 10, 2004, as amended at 70 FR 43046, July 26, 2005; 
79 FR 10967, Feb. 27, 2014; 84 FR 32993, July 11, 2019]



Sec. 524.775  Emodepside and praziquantel.

    (a) Specifications. Each milliliter of solution contains 21.4 
milligrams (mg) emodepside and 85.7 mg praziquantel.
    (b) Sponsor. See No. 058198 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in cats--(1) Amount. The recommended minimum 
dose is 1.36 mg/pound (lb) (3 mg/kilogram (kg)) emodepside and 5.45 mg/
lb (12 mg/kg) praziquantel applied as a single topical dose.
    (2) Indications for use. For the treatment and control of hookworm 
infections caused by Ancylostoma tubaeforme (adults, immature adults, 
and fourth stage larvae), roundworm infections caused by Toxocara cati 
(adults and fourth stage larvae), and tapeworm infections caused by 
Dipylidium caninum (adults) and Taenia taeniaeformis (adults).
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[72 FR 42291, Aug. 2, 2007, as amended at 86 FR 14820, Mar. 19, 2021]



Sec. 524.802  Enrofloxacin and silver sulfadiazine otic emulsion.

    (a) Specifications. Each milliliter contains 5 milligrams (mg) 
enrofloxacin and 10 mg silver sulfadiazine.
    (b) Sponsor. See No. 058198 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use--Dogs--(1) Amount. 5 to 10 drops for dogs 
weighing 35 pounds (lb) or less and 10 to 15 drops for dogs weighing 
more than 35 lb; applied twice daily for up to 14 days.
    (2) Indications for use. For the treatment of otitis externa in 
dogs.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian. Federal law prohibits the extralabel 
use of this drug in food-producing animals.

[65 FR 66620, Nov. 7, 2000, as amended at 79 FR 10967, Feb. 27, 2014; 86 
FR 14821, Mar. 19, 2021]



Sec. 524.814  Eprinomectin.

    (a) Specifications. Each milliliter (mL) contains 5 milligrams (mg) 
of eprinomectin.
    (b) Sponsors. See Nos. 000010 and 055529 in Sec. 510.600(c) of this 
chapter.

[[Page 356]]

    (c) Related tolerances. See Sec. 556.227 of this chapter.
    (d) Special considerations. See Sec. 500.25 of this chapter.
    (e) Conditions of use in cattle--(1) Amount. Apply 5 mg (1 mL) per 
10 kilograms (kg) of body weight (500 micrograms/kg) applied topically 
along backbone from withers to tailhead.
    (2) Indications for use. For treatment and control of 
gastrointestinal roundworms (Haemonchus placei (adult and L4), 
Ostertagia ostertagi (adult and L4, including inhibited L4), 
Trichostrongylus axei (adult and L4), T. colubriformis (adult and L4), 
T. longispicularis (adult), Cooperia oncophora (adult and L4), C. 
punctata (adult and L4), C. surnabada (adult and L4), Nematodirus 
helvetianus (adult and L4), Bunostomum phlebotomum (adult and L4), 
Oesophagostomum radiatum (adult and L4), Strongyloides papillosus 
(adults), Trichuris spp. (adults)); lungworms (Dictyocaulus viviparus, 
adult and L4); cattle grubs (all parasitic stages Hypoderma lineatum, H. 
bovis); lice (Damalinia bovis, Linognathus vituli, Haematopinus 
eurysternus, Solenopotes capillatus); mange mites (Chorioptes bovis, 
Sarcoptes scabiei); and horn flies (Haematobia irritans). Controls and 
protects from reinfection of D. viviparus for 21 days after treatment 
and H. irritans for 7 days after treatment.
    (3) Limitations. A withdrawal period has not been established for 
preruminating calves. Do not use in calves to be processed for veal.

[76 FR 72619, Nov. 25, 2011, as amended at 83 FR 48946, Sept. 28, 2018; 
84 FR 39184, Aug. 9, 2019]



Sec. 524.815  Eprinomectin and praziquantel.

    (a) Specifications. Each milliliter (mL) of solution contains 4 
milligrams (mg) eprinomectin and 83 mg praziquantel.
    (b) Sponsor. See No. 000010 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in cats--(1) Amount. Using the 0.3 mL and 0.9 
mL unit applicators, administer a minimum dose of 0.23 mg eprinomectin 
per pound body weight and 4.55 mg praziquantel per pound body weight by 
topical application on the dorsal midline between the base of the skull 
and the shoulder blades.
    (2) Indications for use. For the prevention of heartworm disease 
caused by Dirofilaria immitis, and for the treatment and control of 
roundworms (adult and fourth stage larval Toxocara cati), hookworms 
(adult and fourth stage larval Ancylostoma tubaeforme; adult Ancylostoma 
braziliense), and tapeworms (adult Dipylidium caninum and Echinococcus 
multilocularis), in cats and kittens 7 weeks of age and older and 1.8 
lbs or greater.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[83 FR 48946, Sept. 28, 2018, as amended at 84 FR 39184, Aug. 9, 2019]



Sec. 524.900  Famphur.

    (a) Specifications. The drug is in liquid form containing 13.2 
percent famphur.
    (b) Sponsor. See No. 000061 in Sec. 510.600(c) of this chapter.
    (c) Special considerations. Do not use on animals simultaneously or 
within a few days before or after treatment with or exposure to 
cholinesterase-inhibiting drugs, pesticides, or chemicals.
    (d) Related tolerances. See Sec. 556.273 of this chapter.
    (e) Conditions of use--(1) Amount. Apply 1 ounce per 200 pounds body 
weight, not to exceed a total dosage of 4 ounces, from the shoulder to 
the tail head as a single treatment. Apply as soon as possible after 
heel fly activity ceases.
    (2) Indications for use in beef and nonlactating dairy cattle. For 
control of cattle grubs and to reduce cattle lice infestations.
    (3) Limitations. Do not slaughter within 35 days after treatment. Do 
not use on lactating dairy cows or dry dairy cows within 21 days of 
freshening, calves less than 3 months old, animals stressed from 
castration, overexcitement or dehorning, sick or convalescent animals. 
Animals may become dehydrated and under stress following shipment. Do 
not treat until they are in good condition. Brahman and Brahman 
crossbreeds are less tolerant of cholinesterase-inhibiting insecticides

[[Page 357]]

than other breeds. Do not treat Brahman bulls. Swine should be 
eliminated from area where runoff occurs.

[40 FR 13873, Mar. 27, 1975, as amended at 49 FR 34352, Aug. 30, 1984; 
57 FR 7652, Mar. 4, 1992; 59 FR 28769, June 3, 1994; 62 FR 55161, Oct. 
23, 1997; 62 FR 61626, Nov. 19, 1997; 69 FR 41427, July 9, 2004; 79 FR 
10968, Feb. 27, 2014; 83 FR 48946, Sept. 28, 2018]



Sec. 524.920  Fenthion.

    (a) Specifications. (1) The drug is a liquid containing:
    (i) 3 percent of fenthion; or
    (ii) 20 percent fenthion.
    (2) The drug is a solution containing either 5.6 or 13.8 percent 
fenthion. Each concentration is available in 2 volumes which are 
contained in single-dose applicators.
    (b) Sponsor. See sponsors in Sec. 510.600(c) of this chapter:
    (1) No. 058198 for use of product described in paragraph (a)(1)(i) 
of this section as in paragraph (d)(1) of this section.
    (2) No. 058198 for use of product described in paragraph (a)(1)(ii) 
of this section as in paragraph (d)(2) of this section.
    (3) No. 058198 for use of products described in paragraph (a)(2) of 
this section as in paragraph (d)(3) of this section.
    (c) Related tolerances. See Sec. 556.280 of this chapter.
    (d) Conditions of use--(1) Beef cattle and nonlactating dairy 
cattle--(i) Amount. It is used at the rate of one-half fluid ounce per 
100 pounds of body weight applied topically on the backline of the 
animal. Only one application per season should be made for grub control 
and this will also provide initial control of lice. A second application 
for lice control may be made if animals become reinfested, but no sooner 
than 35 days after the first treatment. Proper timing of treatment is 
important for grub control; cattle should be treated as soon as possible 
after heel-fly activity ceases.
    (ii) Indications for use. For the control of grubs and lice in beef 
and nonlactating cattle.
    (iii) Limitations. Do not use on animals simultaneously or within a 
few days before or after treatment with or exposure to cholinesterase-
inhibiting drugs, pesticides, or chemicals. Cattle should not be 
slaughtered within 35 days following a single treatment. If a second 
application is made for lice control, cattle should not be slaughtered 
within 45 days of the second treatment. The drug must not be used within 
28 days of freshening of dairy cattle. If freshening should occur within 
28 days after treatment, do not use milk as human food for the balance 
of the 28-day interval. Do not treat lactating dairy cattle; calves less 
than 3 months old; or sick, convalescent, or stressed livestock. Do not 
treat cattle for 10 days before or after shipping, weaning, or dehorning 
or after exposure to contagious infectious diseases.
    (2) Beef cattle and dairy cattle not of breeding age--(i) Amount. It 
is administered as a single, topical application placed on the backline 
of animals as follows: For animals weighing 150 to 300 pounds, apply 4 
milliliters (mL); for animals weighing 301 to 600 pounds, apply 8 mL; 
for animals weighing 601 to 900 pounds, apply 12 mL; for animals 
weighing 901 to 1,200 pounds, apply 16 mL; and for animal weighing over 
1,200 pounds, apply 20 mL. For most effective results, cattle should be 
treated as soon as possible after heel-fly activity ceases. A second 
application is required for animals heavily infested with lice or for 
those which become reinfested. A second application should be made no 
sooner than 35 days after the first treatment.
    (ii) Indications for use. For control of cattle grubs and as an aid 
in controlling lice on beef cattle and on dairy cattle not of breeding 
age.
    (iii) Limitations. Do not use on animals simultaneously or within a 
few days before or after treatment with or exposure to cholinesterase-
inhibiting drugs, pesticides, or chemicals. Host-parasite reactions such 
as bloat, salivation, staggering and paralysis may sometimes occur when 
cattle are treated while the common cattle grub (Hypoderma lineatum) is 
in the gullet, or while the northern cattle grub (H. bovis) is in the 
area of the spinal cord. Cattle should be treated before these stages of 
grub development. Consult your veterinarian, extension livestock 
specialist, or extension entomologist regarding the timing of treatment. 
If it

[[Page 358]]

is impossible to determine the area from which the cattle came and/or 
exact stage of the grubs, it is recommended that the cattle receive only 
a maintenance ration of low-energy feed during the treatment period. 
This lessens the likelihood of severe bloat which may occur in cattle on 
full feed when the common grub is killed while in the gullet. Do not 
treat dairy cattle of breeding age; calves less than 3 months old; sick, 
convalescent, or severely stressed livestock. Do not treat cattle for 10 
days before or after shipping, weaning, dehorning, or after exposure to 
contagious or infectious diseases. Do not slaughter within 45 days of 
treatment.
    (3) Dogs--(i) Amount. Four to 8 milligrams per kilogram of body 
weight. Apply the contents of the proper size, single-dose tube directly 
to one spot on the dog's skin.
    (ii) Indications for use. For flea control on dogs only.
    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

[79 FR 10968, Feb. 27, 2014, as amended at 84 FR 32993, July 11, 2019; 
86 FR 14821, Mar. 19, 2021]



Sec. 524.955  Florfenicol, terbinafine, and betamethasone acetate
otic gel.

    (a) Specifications. Each milliliter of gel contains 10 milligrams 
(mg) florfenicol, 10 mg terbinafine, and 1 mg betamethasone acetate.
    (b) Sponsor. See No. 043264 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in dogs--(1) Amount. Administer one dose (1 
tube) per affected ear(s) and repeat administration in 7 days.
    (2) Indications for use. For the treatment of otitis externa in dogs 
associated with susceptible strains of bacteria (Staphylococcus 
pseudintermedius) and yeast (Malassezia pachydermatis).
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[80 FR 13230, Mar. 13, 2015, as amended at 86 FR 14821, Mar. 19, 2021]



Sec. 524.957  Florfenicol, terbinafine, and mometasone otic solution.

    (a) Specifications. Each single-dose, prefilled dropperette contains 
1 milliliter (mL) of a solution containing 16.6 milligrams (mg) 
florfenicol, 14.8 mg terbinafine (equivalent to 16.6 mg terbinafine 
hydrochloride), and 2.2 mg mometasone furoate.
    (b) Sponsor. See No. 058198 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in dogs--(1) Amount. Administer one 
dropperette (1 mL) per affected ear(s).
    (2) Indications for use. For the treatment of otitis externa in dogs 
associated with susceptible strains of yeast (Malassezia pachydermatis) 
and bacteria (Staphylococcus pseudintermedius).
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[80 FR 76387, Dec. 9, 2015, as amended at 83 FR 64740, Dec. 18, 2018; 86 
FR 14821, Mar. 19, 2021]



Sec. 524.960  Flumethasone, neomycin, and polymyxin B ophthalmic
solution.

    (a) Specifications. Each milliliter of ophthalmic preparation 
contains 0.10 milligram flumethasone, 5.0 milligrams neomycin sulfate 
(3.5 milligrams neomycin base), and 10,000 units of polymyxin B sulfate, 
with or without hydroxypropyl methylcellulose.
    (b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use--(1) Amount--(i) Preparation containing 
hydroxypropyl methylcellulose. Dogs: 1 to 2 drops per eye, every 6 
hours.
    (ii) Preparation without hydroxyproply methylcellulose. Dogs and 
cats: 2 to 3 drops per eye, every 4 hours.
    (2) Indications for use. Treatment of the inflammation, edema, and 
secondary bacterial infections associated with topical ophthalmological 
conditions of the eye such as corneal injuries, incipient pannus, 
superficial keratitis, conjunctivitis, acute nongranulomatous anterior 
uveitis, kerato- conjunctivitis, and blepharitis.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[44 FR 16012, Mar. 16, 1979, as amended at 61 FR 5507, Feb. 13, 1996; 79 
FR 10968, Feb. 27, 2013]

[[Page 359]]



Sec. 524.970  Flunixin.

    (a) Specifications. Each milliliter of solution contains 50 
milligrams (mg) flunixin (equivalent to 83 mg flunixin meglumine).
    (b) Sponsor. See No. 000061 in Sec. 510.600(c) of this chapter.
    (c) Related tolerances. See Sec. 556.286 of this chapter.
    (d) Conditions of use--(1) Amount. Apply only once at a dose of 3.3 
mg flunixin per kg body weight (1.5 mg/lb; 3 mL per 100 lbs) topically 
in a narrow strip along the dorsal midline from the withers to the 
tailhead.
    (2) Indications for use. For the control of pyrexia associated with 
bovine respiratory disease and the control of pain associated with foot 
rot in steers, beef heifers, beef cows, beef bulls intended for 
slaughter, and replacement dairy heifers under 20 months of age.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian. Cattle must not be slaughtered for 
human consumption within 8 days of the last treatment. Not for use in 
female dairy cattle 20 months of age or older, including dry dairy cows; 
use in these cattle may cause drug residues in milk and/or in calves 
born to these cows or heifers. Not for use in suckling beef calves, 
dairy calves, and veal calves. A withdrawal period has not been 
established for this product in pre-ruminating calves.

[83 FR 13635, Mar. 30, 2018]

               Fluocinolone Topical and Otic Dosage Forms



Sec. 524.981  [Reserved]



Sec. 524.981a  Fluocinolone cream.

    (a) Specifications. The drug contains 0.025 percent fluocinolone 
acetonide.
    (b) Sponsor. See No. 099207 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in dogs--(1) Amount. A small amount is applied 
to the affected area two or three times daily.
    (2) Indications for use. For the relief of pruritis and inflammation 
associated with certain superficial acute and chronic dermatoses. It is 
used in the treatment of allergic and acute moist dermatitis and for the 
relief of superficial inflammation caused by chemical burns and physical 
abrasions.
    (3) Federal law restricts this drug to use by or on the order of a 
licensed veterinarian.

[40 FR 13873, Mar. 27, 1975, as amended at 62 FR 40932, July 31, 1997; 
79 FR 10968, Feb. 27, 2014]



Sec. 524.981b  Fluocinolone solution.

    (a) Specifications. The drug contains 0.01 percent fluocinolone 
acetonide.
    (b) Sponsor. See No. 099207 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in dogs--(1) Amount. A small amount of 
solution is applied to the affected area two or three times daily.
    (2) Indications for use--(i) Dogs. For the relief of pruritis and 
inflammation associated with otitis externa and certain superficial 
acute and chronic dermatoses.
    (ii) Cats. For the relief of pruritis and inflammation associated 
with acute otitis externa and certain superficial acute and chronic 
dermatoses.
    (3) Federal law restricts this drug to use by or on the order of a 
licensed veterinarian.

[40 FR 13873, Mar. 27, 1975, as amended at 62 FR 40932, July 31, 1997; 
79 FR 10969, Feb. 27, 2014]



Sec. 524.981c  Fluocinolone and neomycin cream.

    (a) Specifications. The drug contains 0.025 percent fluocinolone 
acetonide and 0.5 percent neomycin sulfate (0.35 percent neomycin base).
    (b) Sponsor. See No. 099207 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in dogs--(1) Amount. A small amount is applied 
to the affected area two or three times daily.
    (2) Indications for use--(i) Dogs. For the relief of pruritis and 
inflammation associated with superficial acute and chronic dermatoses. 
It is used in the treatment of allergic and acute moist dermatitis and 
nonspecific dermatoses.
    (ii) Dogs and cats. Used in the treatment of wound infections.

[[Page 360]]

    (3) Federal law restricts this drug to use by or on the order of a 
licensed veterinarian.

[40 FR 13873, Mar. 27, 1975, as amended at 62 FR 40932, July 31, 1997; 
79 FR 10969, Feb. 27, 2014]



Sec. 524.981d  Fluocinolone and dimethyl sulfoxide solution.

    (a) Specifications. Each milliliter of solution contains 0.01 
percent fluocinolone acetonide and 20 percent dimethyl sulfoxide.
    (b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in dogs--(1) Amount. Instill 1 to 2 
milliliters into each anal sac following expression of anal sac 
contents.
    (2) Indications for use. For the relief of impaction commonly 
present in apparently normal anal sacs, for the reversal of inflammatory 
changes associated with abnormal anal sacs, and to counteract the 
offensive odor of anal sac secretions.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[79 FR 10969, Feb. 27, 2014]



Sec. 524.981e  Fluocinolone and dimethyl sulfoxide otic solution.

    (a) Specifications. Each milliliter of solution contains 0.01 
percent fluocinolone acetonide and 60 percent dimethyl sulfoxide.
    (b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in dogs--(1) Amount. Instill 4 to 6 drops (0.2 
milliliter) twice daily into the ear canal for a maximum period of 14 
days. The total dosage used should not exceed 17 milliliters.
    (2) Indications for use. For the relief of pruritis and inflammation 
associated with acute and chronic otitis.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[79 FR 10969, Feb. 27, 2014]



Sec. 524.998  Fluralaner.

    (a) Specifications. Each milliliter of solution contains 280 
milligrams (mg) fluralaner.
    (b) Sponsor. See No. 000061 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use--(1) Dogs--(i) Amount. Administer topically as 
a single dose every 12 weeks according to the label dosage schedule to 
provide a minimum dose of 11.4 mg/lb (25 mg/kg) body weight. May be 
administered every 8 weeks in case of potential exposure to Amblyomma 
americanum ticks.
    (ii) Indications for use. Kills adult fleas; for the treatment and 
prevention of flea infestations (Ctenocephalides felis) and the 
treatment and control of tick infestations (Ixodes scapularis (black-
legged tick), Dermacentor variabilis (American dog tick), and 
Rhipicephalus sanguineus (brown dog tick)) for 12 weeks in dogs and 
puppies 6 months of age and older, and weighing 4.4 lb or greater; for 
the treatment and control of A. americanum (lone star tick) infestations 
for 8 weeks in dogs and puppies 6 months of age and older, and weighing 
4.4 lb or greater.
    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.
    (2) Cats--(i) Amount. Administer topically as a single dose every 12 
weeks according to the label dosage schedule to provide a minimum dose 
of 18.2 mg/lb (40 mg/kg) body weight. May be administered every 8 weeks 
in case of potential exposure to D. variabilis ticks.
    (ii) Indications for use. Kills adult fleas; for the treatment and 
prevention of flea infestations (C. felis) and the treatment and control 
of I. scapularis (black-legged tick) infestations for 12 weeks in cats 
and kittens 6 months of age and older, and weighing 2.6 lb or greater; 
for the treatment and control of D. variabilis (American dog tick) 
infestations for 8 weeks in cats and kittens 6 months of age and older, 
and weighing 2.6 lb or greater.
    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

[81 FR 67152, Sept. 30, 2016, as amended at 82 FR 43485, Sept. 18, 2017]



Sec. 524.1001  Furalaner and moxidectin.

    (a) Specifications. Each milliliter of solution contains 280 
milligram (mg) furalaner and 14 mg moxidectin. Each individually 
packaged tube contains either 112.5 mg furalaner and 5.6 mg

[[Page 361]]

moxidectin; 250 mg furalaner and 12.5 mg moxidectin; or 500 mg furalaner 
and 25 mg moxidectin.
    (b) Sponsor. See No. 000061 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use--(1) Amount. Administer topically as a single 
dose every 2 months to provide a minimum dose of 18.2 mg/lb (40 mg/kg) 
fluralaner and 0.9 mg/lb (2 mg/kg) moxidectin.
    (2) Indications for use. For the prevention of heartworm disease 
caused by Dirofilaria immitis and for the treatment of infections with 
intestinal roundworm (Toxocara cati, 4th stage larvae, immature adults, 
and adults) and hookworm (Ancylostoma tubaeforme, 4th stage larvae, 
immature adults, and adults); kills adult fleas and is indicated for the 
treatment and prevention of flea infestations (Ctenocephalides felis) 
and the treatment and control of tick infestations (Ixodes scapularis 
(black-legged tick) and Dermacentor variabilis (American dog tick)) for 
2 months in cats and kittens 6 months of age and older and weighing 2.6 
lb or greater.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[85 FR 18120, Apr. 1, 2020]



Sec. 524.1005  Furazolidone powder.

    (a) Specifications. The product contains either 4 or 10 percent 
furazolidone in inert dispersing agent and propellant.
    (b) Sponsors. (1) See No. 051031 in Sec. 510.600(c) of this chapter 
for use as in paragraphs (c)(1), (c)(2)(i), (c)(2)(ii), and (c)(3) of 
this section.
    (2) See No. 017135 for use of the 4 percent product as in paragraph 
(c)(2)(iv) of this section.
    (c) Conditions of use--(1) Amount. Hold container about 6 to 12 
inches from the eye or affected area and apply only enough powder to 
impart a light yellow color.
    (2) Indications of use--(i) Dogs. For treatment or prevention of 
bacterial infection of superficial wounds, abrasions, lacerations, and 
pyogenic dermatitis.
    (ii) Horses. For treatment or prevention of bacterial infection of 
superficial wounds, abrasions, lacerations, and following firing (heat 
or electrocautery).
    (iii) [Reserved]
    (iv) Horses and ponies. For treatment or prevention of bacterial 
infection of superficial wounds, abrasions, and lacerations caused by 
Staphylococcus aureus, Streptococcus spp. and Proteus spp. sensitive to 
furazolidone.
    (3) Limitations. For topical application in horses, ponies, and 
dogs: Clean affected area thoroughly, apply drug once or twice daily, 
and repeat treatment as required. Use only as recommended by a 
veterinarian in treatment of puncture wounds, wounds requiring surgical 
debridement or suturing, those of a chronic nature involving proud 
flesh, generalized and chronic infections of the skin, and those skin 
conditions associated with intense itching. If redness, irritation, or 
swelling persists or increases, discontinue use and consult a 
veterinarian. Do not use in horses intended for human consumption.

[45 FR 49543, July 25, 1980, as amended at 50 FR 30153, July 24, 1985; 
56 FR 50653, Oct. 8, 1991; 57 FR 31314, July 15, 1992; 60 FR 55659, Nov. 
2, 1995; 65 FR 41588, July 6, 2000; 79 FR 10969, Feb. 27, 2014; 82 FR 
11508, Feb. 24, 2017]



Sec. 524.1044  Gentamicin ophthalmic and topical dosage forms.



Sec. 524.1044a  Gentamicin ophthalmic solution.

    (a) Specifications. Each milliliter of solution contains gentamicin 
sulfate equivalent to 3 milligrams of gentamicin.
    (b) Sponsors. See Nos. 000061 and 059399 in Sec. 510.600(c) of this 
chapter.
    (c) Conditions of use in dogs and cats--(1) Amount. Administer 1 or 
2 drops into the conjunctival sac 2 to 4 times a day.
    (2) Indications for use. For the topical treatment of infections of 
the conjunctiva caused by susceptible bacteria.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[80 FR 18776, Apr. 8, 2015]



Sec. 524.1044b  Gentamicin and betamethasone otic solution.

    (a) Specifications. Each milliliter of solution contains gentamicin 
sulfate equivalent to 3 milligrams (mg) gentamicin base and 
betamethasone

[[Page 362]]

valerate equivalent to 1 mg betamethasone alcohol.
    (b) Sponsors. See Nos. 000061 and 054925 in Sec. 510.600(c) of this 
chapter.
    (c) Conditions of use--(1) Amounts and indications for use. (i) For 
the treatment of acute and chronic otitis externa caused by bacteria 
sensitive to gentamicin in dogs, instill three to eight drops of 
solution into the ear canal twice daily for 7 to 14 days.
    (ii) For the treatment of infected superficial lesions caused by 
bacteria sensitive to gentamicin in dogs and cats, apply a sufficient 
amount of the drug to cover the treatment area twice daily for 7 to 14 
days.
    (2) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[71 FR 13542, Mar. 16, 2006]



Sec. 524.1044c  Gentamicin ophthalmic ointment.

    (a) Specifications. Each gram of ointment contains gentamicin 
sulfate equivalent to 3 milligrams of gentamicin.
    (b) Sponsors. See Nos. 000061 and 026637 in Sec. 510.600(c) of this 
chapter.
    (c) Conditions of use in dogs and cats--(1) Amount. Apply 
approximately a 1/2-inch strip to the affected eye 2 to 4 times a day.
    (2) Indications for use. For treatment of conjunctivitis caused by 
susceptible bacteria.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[69 FR 47363, Aug. 5, 2004, as amended at 77 FR 64717, Oct. 23, 2012; 85 
FR 4208, Jan. 24, 2020]



Sec. 524.1044d  Gentamicin and betamethasone ointment.

    (a) Specifications. Each gram of ointment contains gentamicin 
sulfate equivalent to 3 milligrams of gentamicin base and betamethasone 
valerate equivalent to 1 milligram of betamethasone.
    (b) Sponsor. See No. 000061 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in dogs--(1) Amount--(i) Otitis externa. 
Instill 3 to 8 drops into the ear canal twice daily for 7 days.
    (ii) Infected superficial lesions. Apply to cover the treatment area 
twice daily for 7 to 14 days.
    (2) Indications for use. For the treatment of acute and chronic 
otitis externa and infected superficial lesions caused by bacteria 
sensitive to gentamicin.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[47 FR 26378, June 18, 1982, as amended at 52 FR 7832, Mar. 13, 1987; 79 
FR 10969, Feb. 27, 2014]



Sec. 524.1044e  Gentamicin spray.

    (a) Specification. Each milliliter of sterile aqueous solution 
contains gentamicin sulfate equivalent to 1.07 milligrams of gentamicin.
    (b) Sponsor. See No. 000061 in Sec. 510.600(c) of this chapter.
    (c) Related tolerances. See Sec. 556.300 of this chapter.
    (d) Conditions of use in cattle--(1) Amount. Hold the sprayer 
upright 3 to 6 inches from the affected eye, with the opening directed 
towards the eye, and pump once. Treat once daily for up to 3 days.
    (2) Indications for use. For the treatment of pinkeye in cattle 
(infectious bovine keratoconjunctivitis) caused by Moraxella bovis.
    (3) Limitations. Conditions other than bacterial infections of the 
bovine eye and infectious keratoconjunctivitis caused by Moraxella bovis 
may produce similar signs. If conditions persists or increases, 
discontinue use and consult a veterinarian.

[48 FR 41157, Sept. 14, 1983, as amended 52 FR 7833, Mar. 13, 1987; 79 
FR 10969, Feb. 27, 2014; 84 FR 32993, July 11, 2019]



Sec. 524.1044f  Gentamicin and betamethasone spray.

    (a) Specifications. Each milliliter of spray contains gentamicin 
sulfate equivalent to 0.57 milligram (mg) gentamicin base and 
betamethasone valerate equivalent to 0.284 mg betamethasone.
    (b) Sponsors. See Nos. 000061, 054925, 058005, and 058829 in Sec. 
510.600(c) of this chapter.
    (c) Conditions of use in dogs--(1) Amount. Hold bottle upright 3 to 
6 inches from the lesion and depress the

[[Page 363]]

sprayer head twice. Administer two spray actuations two to four times 
daily for 7 days.
    (2) Indications for use. For the treatment of infected superficial 
lesions caused by bacteria susceptible to gentamicin.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[71 FR 13542, Mar. 16, 2006, as amended at 72 FR 5929, Feb. 8, 2007; 74 
FR 22822, May 15, 2009; 77 FR 3598, Jan. 25, 2012; 85 FR 4208, Jan. 24, 
2020]



Sec. 524.1044g  Gentamicin, betamethasone, and clotrimazole ointment.

    (a) Specifications. Each gram (g) of ointment contains gentamicin 
sulfate equivalent to 3 milligrams (mg) gentamicin base, betamethasone 
valerate equivalent to 1 mg betamethasone, and 10 mg clotrimazole.
    (b) Sponsors. See sponsors in Sec. 510.600(c) of this chapter for 
uses as in paragraph (c) of this section.
    (1) No. 000061 for use of 7.5- or 15-gram (g) tubes, 12.5-, 30-, or 
215-g bottles.
    (2) No. 054925 for use of 7.5- or 15-g tubes; 10-, 15-, 25-, or 215-
g bottles.
    (3) No. 069043 for use of 10-, 20-, 40-, or 215-g bottles.
    (4) No. 025463 for use of 7.5- or 15-g tubes, or 215-g bottles.
    (c) Conditions of use in dogs--(1) Amount. Instill ointment twice 
daily into the ear canal for 7 consecutive days.
    (i) From 7.5- or 15-g tubes; 10-, 12.5-, 15-, 25-, or 30-g bottles: 
4 drops for dogs weighing less than 30 pounds (lb) or 8 drops for dogs 
weighing 30 lb or more.
    (ii) From 20-, 40-, or 215-g bottles: 2 drops for dogs weighing less 
than 30 lb or 4 drops for dogs weighing 30 lb or more.
    (ii) From 20- or 215-g bottles: 2 drops for dogs weighing less than 
30 lb or 4 drops for dogs weighing 30 lb or more.
    (2) Indications for use. For the treatment of acute and chronic 
canine otitis externa associated with yeast (Malassezia pachydermatis, 
formerly Pityrosporum canis) and/or bacteria susceptible to gentamicin.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[58 FR 38973, July 21, 1993, as amended at 63 FR 31932, June 11, 1998; 
68 FR 42970, July 21, 2003; 70 FR 8291, Feb. 18, 2005; 71 FR 13542, Mar. 
16, 2006; 71 FR 16481, Apr. 3, 2006; 71 FR 38261, July 6, 2006; 71 FR 
56867, Sept. 28, 2006; 78 FR 17597, Mar. 22, 2013; 79 FR 10969, Feb. 27, 
2014; 81 FR 17608, Mar. 30, 2016]



Sec. 524.1044h  Gentamicin, mometasone, and clotrimazole otic 
suspension.

    (a) Specifications. Each gram of suspension contains gentamicin 
sulfate, United States Pharmacopeia (USP) equivalent to 3 milligram (mg) 
gentamicin base, mometasone furoate monohydrate or mometasone furoate 
anhydrous, USP, equivalent to 1 mg mometasone, and 10 mg clotrimazole, 
USP.
    (b) Sponsors. See Nos. 000061 and 054925 in Sec. 510.600(c) of this 
chapter.
    (c) Conditions of use in dogs--(1) Amount. For dogs weighing less 
than 30 pounds (lb), instill 4 drops from the 7.5-, 15-, or 30-gram (g) 
bottle into the ear canal (2 drops from the 215-g bottle) or, for dogs 
weighing 30 lb or more, instill 8 drops from the 7.5-, 15-, or 30-g 
bottle into the ear canal (4 drops from the 215-g bottle), once or twice 
daily for 7 days.
    (2) Indications for use. For the treatment of otitis externa caused 
by susceptible strains of yeast (Malassezia pachydermatis) and bacteria 
(Pseudomonas spp. [including P. aeruginosa], coagulase-positive 
staphylococci, Enterococcus faecalis, Proteus mirabilis, and beta-
hemolytic streptococci).
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[66 FR 712, Jan. 4, 2001, as amended at 68 FR 15370, Mar. 31, 2003; 70 
FR 36338, June 23, 2005; 79 FR 10969, Feb. 27, 2014; 81 FR 59134, Aug. 
29, 2016]



Sec. 524.1044i  Gentamicin and betamethasone ophthalmic solution.

    (a) Specifications. Each milliliter (mL) of solution contains 
gentamicin sulfate equivalent to 3 milligrams (mg) of gentamicin base 
and 1 mg betamethasone acetate equivalent to 0.89 mg betamethasone 
alcohol.

[[Page 364]]

    (b) Sponsor. See No. 000061 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in dogs--(1) Amount. Instill one or two drops 
of solution in the conjunctival sac three or four times a day.
    (2) Indications for use. For treatment of external eye infections 
and inflammation.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[75 FR 54492, Sept. 8, 2010, as amended at 80 FR 13230, Mar. 13, 2015]



Sec. 524.1132  Hydrocortisone, miconazole, and gentamicin otic
suspension.

    (a) Specifications. Each milliliter (mL) of suspension contains 1.11 
milligrams (mg) hydrocortisone aceponate, 17.4 mg miconazole nitrate, 
and 1.5 mg gentamicin (as gentamicin sulfate).
    (b) Sponsor. See No.051311 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in dogs--(1) Amount. Instill 1.0 mL in the 
affected ear once daily for 5 days.
    (2) Indications for use. For the treatment of otitis externa in dogs 
associated with susceptible strains of yeast (Malassezia pachydermatis) 
and bacteria (Staphylococcus pseudintermedius).
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[76 FR 78150, Dec. 16, 2011, as amended at 83 FR 13635, Mar. 30, 2018]



Sec. 524.1140  Imidacloprid and ivermectin.

    (a) Specifications. The product is available in unit applicator 
tubes containing 0.4, 1.0, 2.5, or 4.0 milliliters (mL). Each mL of 
solution contains 100 milligrams (mg) imidacloprid and 800 micrograms 
([micro]g) ivermectin.
    (b) Sponsor. See No. 058198 in Sec. 510.600(c) of this chapter.
    (c) Conditions of Use in Dogs--(1) Amount. The recommended minimum 
dosage is 4.5 mg/pound (lb) (10 mg/kilogram (kg)) of imidacloprid and 
36.4 [micro]g/lb (80 [micro]g/kg) of ivermectin, topically once a month.
    (2) Indications for Use. For the prevention of heartworm disease 
caused by Dirofilaria immitis; kills adult fleas and is indicated for 
the treatment of flea infestations (Ctenocephalides felis).
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[67 FR 78685, Dec. 26, 2002, as amended at 86 FR 14821, Mar. 19, 2021]



Sec. 524.1146  Imidacloprid and moxidectin.

    (a) Specifications. Each milliliter of solution contains:
    (1) 100 milligrams (mg) imidacloprid and 25 mg moxidectin; or
    (2) 100 mg imidacloprid and 10 mg moxidectin.
    (b) Sponsors. See sponsor numbers in Sec. 510.600(c) of this 
chapter as follows:
    (1) Nos. 017030 and 058198 for use of product described in paragraph 
(a)(1) of this section as in paragraph (d)(1) of this section.
    (2) Nos. 017030 and 058198 for use of product described in paragraph 
(a)(2) of this section as in paragraph (d)(2) of this section.
    (3) No. 058198 for use of product described in paragraph (a)(2) of 
this section as in paragraph (d)(3) of this section.
    (c) Special considerations. Federal law restricts this drug to use 
by or on the order of a licensed veterinarian.
    (d) Conditions of use--(1) Dogs--(i) Amount. Topically apply 4.5 mg/
lb body weight (10 mg/kg) imidacloprid and 1.1 mg/lb (2.5 mg/kg) 
moxidectin, once a month.
    (ii) Indications for use. (A) For the prevention of heartworm 
disease caused by Dirofilaria immitis; and the treatment and control of 
intestinal roundworms (Toxocara canis and Toxascaris leonina), hookworms 
(Ancylostoma caninum and Uncinaria stenocephala), and whipworms 
(Trichuris vulpis); kills adult fleas and treats flea infestations 
(Ctenocephalides felis).
    (B) For treatment of Dirofilaria immitis circulating microfilariae 
in heartworm-positive dogs and the treatment and control of sarcoptic 
mange caused by Sarcoptes scabiei var. canis.
    (2) Cats--(i) Amount. Topically apply 4.5 mg/lb body weight (10 mg/
kg) imidacloprid and 0.45 mg/lb (1.0 mg/kg) moxidectin, once a month.
    (ii) Indications for use. For the prevention of heartworm disease 
caused by Dirofilaria immitis; for the treatment and control of ear mite 
(Otodectes

[[Page 365]]

cynotis) infestations, intestinal roundworms (Toxocara cati), and 
hookworms (Ancylostoma tubaeforme); kills adult fleas and treats flea 
infestations (Ctenocephalides felis).
    (3) Ferrets--(i) Amount. Topically apply 9.0 mg/lb body weight (20 
mg/kg) imidacloprid and 0.9 mg/lb (2 mg/kg) moxidectin, once a month.
    (ii) Indications for use. For the prevention of heartworm disease 
caused by Dirofilaria immitis; kills adult fleas (Ctenocephalides felis) 
and is indicated for the treatment of flea infestations on ferrets.

[72 FR 10597, Mar. 9, 2007, as amended at 78 FR 73698, Dec. 9, 2013; 85 
FR 18120, Apr. 1, 2020; 86 FR 13185, Mar. 8, 2021; 86 FR 14821, Mar. 19, 
2021]



Sec. 524.1193  Ivermectin topical solution.

    (a) Specifications. Each milliliter (mL) of solution contains 5 
milligrams of ivermectin.
    (b) Sponsors. See sponsors in Sec. 510.600(c) of this chapter for 
use as in paragraph (e) of this section.
    (1) Nos. 000010, 055529, 058829, 061133 for use as in paragraphs 
(e)(1), (e)(2)(i), (e)(2)(iii), and (e)(3) of this section.
    (2) Nos. 016592 and 054925, for use as in paragraphs (e)(1), 
(e)(2)(i), (e)(2)(ii), and (e)(3) of this section.
    (c) Related tolerances. See Sec. 556.344 of this chapter.
    (d) Special considerations. See Sec. 500.25 of this chapter.
    (e) Conditions of use in cattle--(1) Amount. One mL per 22 pounds 
(0.5 milligram per kilogram) of body weight applied topically to the 
back of the animal.
    (2) Indications for use. (i) It is used for the treatment and 
control of: Gastrointestinal roundworms (adults and fourth-stage larvae) 
Ostertagia ostertagi (including inhibited stage), Haemonchus placei, 
Trichostrongylus axei, T. colubriformis, Cooperia oncophora, C. 
punctata, C. surnabada, Oesophagostomum radiatum; (adults) Strongyloides 
papillosus, Trichuris spp.; lungworms (adults and fourth-stage larvae) 
Dictyocaulus viviparus; cattle grubs (parasitic stages) Hypoderma bovis, 
H. lineatum; mites Sarcoptes scabiei var. bovis; lice Linognathus 
vituli, Haematopinus eurysternus, Damalinia bovis, Solenoptes 
capillatus; and horn flies Haematobia irritans.
    (ii) It controls infections and prevents reinfection with O. 
ostertagi, O. radiatum, H. placei, T. axei, C. punctata, and C. 
oncophora for 14 days after treatment.
    (iii) It controls infections and prevents reinfection with O. 
radiatum and D. viviparus for 28 days after treatment, C. punctata and 
T. axei for 21 days after treatment, O. ostertagi, H. placei, C. 
oncophora, and C. surnabada for 14 days after treatment, and D. bovis 
for 56 days after treatment.
    (3) Limitations. Do not treat cattle within 48 days of slaughter. 
Because a withdrawal time in milk has not been established, do not use 
in female dairy cattle of breeding age. A withdrawal period has not been 
established for this product on preruminating calves. Do not use on 
calves to be processed for veal.

[55 FR 50551, Dec. 7, 1990, as amended at 62 FR 38908, July 21, 1997; 62 
FR 63271, Nov. 28, 1997; 63 FR 44385, Aug. 19, 1998; 66 FR 13236, Mar. 
5, 2001; 66 FR 63165, Dec. 5, 2001; 68 FR 3817, Jan. 27, 2003; 68 FR 
4713, Jan. 30, 2003; 69 FR 501, Jan. 6, 2004; 69 FR 62181, Oct. 25, 
2004; 71 FR 13542, Mar. 16, 2006; 72 FR 6464, Feb. 12, 2007; 74 FR 
36112, July 22, 2009; 75 FR 26648, May 12, 2010; 76 FR 81807, Dec. 29, 
2011; 78 FR 17597, Mar. 22, 2013; 78 FR 63872, Oct. 25, 2013; 81 FR 
25328, Apr. 28, 2016; 83 FR 13635, Mar. 30, 2018; 84 FR 8974, Mar. 13, 
2019; 84 FR 39184, Aug. 9, 2019; 86 FR 13185, Mar. 8, 2021]



Sec. 524.1195  Ivermectin otic suspension.

    (a) Specifications. Each tube contains 0.5 milliliter (mL) of a 0.01 
percent suspension of ivermectin.
    (b) Sponsor. See No. 000010 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use--(1) Amount. Administer the contents of one 
0.5-mL tube topically into each external ear canal.
    (2) Indications for use. For the treatment of adult ear mite 
(Otodectes cynotis) infestations in cats and kittens 4 weeks of age and 
older. Effectiveness against eggs and immature stages has not been 
proven.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[66 FR 7578, Jan. 24, 2001, as amended at 74 FR 26782, June 4, 2009]

[[Page 366]]



Sec. 524.1200  Kanamycin ophthalmic and topical dosage forms.



Sec. 524.1200a  Kanamycin ophthalmic ointment.

    (a) Specifications. Each gram of ointment contains 3.5 milligrams 
kanamycin activity as kanamycin sulfate.
    (b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in dogs--(1) Amount. Apply a thin film to the 
affected eye three or four times daily or more frequently if deemed 
advisable. Treatment should be continued for at least 48 hours after the 
eye appears normal.
    (2) Indications for use. For the treatment of various eye infections 
(conjunctivitis, blepharitis, dacryocystitis, keratitis, and corneal 
ulcerations) due to bacteria sensitive to kanamycin. For prophylaxis in 
traumatic conditions, removal of foreign bodies, and intraocular 
surgery.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[79 FR 10969, Feb. 27, 2014]



Sec. 524.1200b  Kanamycin ophthalmic solution.

    (a) Specifications. Each milliliter of solution contains 10 
milligrams kanamycin activity as kanamycin sulfate.
    (b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in dogs--(1) Amount. Instill a few drops into 
the affected eye every 3 hours or more frequently if deemed advisable. 
Administer as frequently as possible for the first 48 hours, after which 
the frequency of applications may be decreased. Treatment should be 
continued for at least 48 hours after the eye appears normal.
    (2) Indications for use. For the treatment of various eye infections 
(conjunctivitis, blepharitis, dacryocystitis, keratitis, and corneal 
ulcerations) due to bacteria sensitive to kanamycin. For prophylaxis in 
traumatic conditions, removal of foreign bodies, and intraocular 
surgery.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[79 FR 10970, Feb. 27, 2014]



Sec. 524.1204  Kanamycin, amphomycin, and hydrocortisone ointment.

    (a) Specifications. Each gram of ointment contains 5 milligrams 
kanamycin activity as kanamycin sulfate, 5 milligrams of amphomycin 
activity as the calcium salt, and 10 milligrams of hydrocortisone 
acetate.
    (b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in dogs--(1) Amount. Apply to the affected 
areas of the skin at least twice daily. In severe or widespread lesions 
it may be desirable to apply the ointment more than twice daily. After 
some improvement is observed, treatment can usually be reduced to once 
daily.
    (2) Indications for use. For the treatment of acute otitis externa, 
furunculosis, folliculitis, pruritus, anal gland infections, erythema, 
decubital ulcers, superficial wounds, and superficial abscesses 
associated with bacterial infections caused by organisms susceptible to 
one or both antibiotics.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[79 FR 10970, Feb. 27, 2014]



Sec. 524.1240  Levamisole.

    (a) Specifications. The drug contains 200 milligrams of levamisole 
per milliliter of diethylene glycol monobutyl ether (DGME) solution.
    (b) Sponsors. See Nos. 000061 and 054771 in Sec. 510.600(c) of this 
chapter.
    (c) Related tolerances. See Sec. 556.350 of this chapter.
    (d) Conditions of use. Cattle--(1) Amount. 2.5 milliliters per 110 
pounds (10 milligrams of levamisole per kilogram) of body weight as a 
single dose topically to the back of the animal.
    (2) Indications for use. Anthelmintic effective against stomach 
worms (Haemonchus, Trichostrongylus, Ostertagia), intestinal worms 
(Trichostrongylus, Cooperia, Nematodirus, Bunostomum, Oesophagostomum, 
Chabertia), and lungworms (Dictyocaulus).

[[Page 367]]

    (3) Limitations. Conditions of constant helminth exposure may 
require retreatment within 2 to 4 weeks after the first treatment. 
Cattle must not be slaughtered within 9 days following last treatment. 
Do not administer to dairy animals of breeding age. Do not treat animals 
before dipping or prior to exposure to heavy rain. Consult your 
veterinarian for assistance in the diagnosis, treatment, and control of 
parasitism, and before using in severely debilitated animals.

[52 FR 10887, Apr. 6, 1987, as amended at 53 FR 7504, Mar. 9, 1988; 62 
FR 61626, Nov. 19, 1997; 67 FR 78355, Dec. 24, 2002; 79 FR 10970, Feb. 
27, 2014]



Sec. 524.1376  2-Mercaptobenzothiazole solution.

    (a) Specifications. The drug contains 1.3 percent 2-
mercaptobenzothiazole in a suitable solvent.
    (b) Sponsor. See 017135 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use--(1) Amount. Apply twice daily to affected 
area.
    (2) Indications for use. For dogs as an aid in the treatment of hot 
spots (moist dermatitis) and as first aid for scrapes and abrasions.
    (3) Limitations. Clip hair from affected area before applying. If no 
improvement is seen within 1 week, consult a veterinarian.

[48 FR 15618, Apr. 12, 1983, as amended at 65 FR 50913, Aug. 22, 2000; 
68 FR 33381, June 4, 2003]



Sec. 524.1443  Miconazole.

    (a) Specifications. (1) Each gram of cream contains miconazole 
nitrate equivalent to 20 milligrams miconazole base.
    (2) Each gram of lotion or spray contains miconazole nitrate 
equivalent to 1 percent miconazole base.
    (b) Sponsors. See Sec. 510.600(c) of this chapter for use as in 
paragraph (c) of this section:
    (1) No. 000061 for use of cream, lotion, and spray;
    (2) Nos. 054925 and 058829 for use of lotion and spray.
    (c) Conditions of use in dogs and cats--(1) Amount. Apply once daily 
by rubbing into or spraying a light covering on the infected site and 
the immediate surrounding vicinity. Continue treatment for 2 to 4 weeks 
until infection is completely eradicated as determined by appropriate 
laboratory examination.
    (2) Indications for use. For topical treatment of infections caused 
by Microsporum canis, Microsporum gypseum, and Trichophyton 
mentagrophytes.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[71 FR 13542, Mar. 16, 2006]



Sec. 524.1445  Miconazole, polymixin B, and prednisolone suspension.

    (a) Specifications. Each milliliter of suspension contains 23 
milligrams (mg) miconazole nitrate, 0.5293 mg polymixin B sulfate, and 5 
mg prednisolone acetate.
    (b) Sponsor. See No. 058198 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in dogs--(1) Amount. Instill five drops in the 
ear canal twice daily for 7 consecutive days.
    (2) Indications for use. For the treatment of canine otitis externa 
associated with susceptible strains of yeast (Malassezia pachydermatis) 
and bacteria (Staphylococcus pseudintermedius).
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[ 75 FR 4693, Jan. 29, 2010, as amended at 77 FR 46613, Aug. 6, 2012; 81 
FR 48703, July 26, 2016]



Sec. 524.1446  Milbemycin otic solution.

    (a) Specifications. Each tube contains 0.25 milliliter of a 0.1 
percent solution of milbemycin oxime.
    (b) Sponsor. See No. 058198 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use--(1) Amount. One tube administered topically 
into each external ear canal.
    (2) Indications for use. For the treatment of ear mite (Otodectes 
cynotis) infestations in cats and kittens 4 weeks of age and older. 
Effectiveness is maintained throughout the life cycle of the ear mite.

[[Page 368]]

    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[65 FR 13905, Mar. 15, 2000, as amended at 66 FR 13849, Mar. 8, 2001]



Sec. 524.1448  Mirtazapine transdermal ointment.

    (a) Specifications. Each gram of ointment contains 20 milligrams 
(mg) mirtazapine.
    (b) Sponsor. See No. 043264 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use--(1) Amount. Administer topically by applying 
a 1.5 inch ribbon of ointment (approximately 2 mg) on the inner pinna of 
the cat's ear once daily for 14 days. Alternate the daily application of 
ointment between the left and right inner pinna of the ears.
    (2) Indications for use. For the management of weight loss in cats.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[83 FR 64740, Dec. 18, 2018, as amended at 85 FR 45308, July 28, 2020]



Sec. 524.1450  Moxidectin.

    (a) Specifications. Each milliliter of solution contains:
    (1) 5 milligrams (mg) moxidectin (0.5 percent solution).
    (2) 25 mg moxidectin (2.5 percent solution).
    (b) Sponsors. See sponsor numbers in Sec. 510.600 of this chapter:
    (1) No. 058198 for use of product described in paragraph (a)(1) of 
this section as in paragraph (d)(1) of this section; and
    (2) No. 058198 for use of product described in paragraph (a)(2) of 
this section as in paragraph (d)(2) of this section.
    (c) Related tolerances. See Sec. 556.426 of this chapter.
    (d) Conditions of use--(1) Cattle--(i) Amount. Administer topically 
0.5 mg per kilogram (kg) of body weight.
    (ii) Indications for use. Beef and dairy cattle: For treatment and 
control of internal and external parasites: gastrointestinal roundworms 
(Ostertagia ostertagi (adult and L4, including inhibited larvae), 
Haemonchus placei (adult and L4), Trichostrongylus axei (adult and L4), 
T. colubriformis (adult and L4), Cooperia oncophora (adult and L4), C. 
pectinata (adult), C. punctata (adult and L4), C. spatulata (adult), C. 
surnabada (adult and L4), Bunostomum phlebotomum (adult), 
Oesophagostomum radiatum (adult and L4), Nematodirus helvetianus (adult 
and L4)); lungworms (Dictyocaulus viviparus (adult and L4)); cattle 
grubs (Hypoderma bovis, H. lineatum); mites (Chorioptes bovis, Psoroptes 
ovis (P. communis var. bovis)); lice (Linognathus vituli, Haematopinus 
eurysternus, Solenopotes capillatus, Bovicola (Damalinia) bovis); and 
horn flies (Haematobia irritans). To control infections and to protect 
from reinfection with H. placei for 14 days after treatment, O. radiatum 
and O. ostertagi for 28 days after treatment, and D. viviparus for 42 
days after treatment.
    (iii) Limitations. A withdrawal period has not been established for 
this product on preruminating calves. Do not use on calves to be 
processed for veal. See Sec. 500.25 of this chapter.
    (2) Dogs--(i) Amount. Administer topically a minimum of 1.1 mg per 
pound (lb) (2.5 mg/kg) of body weight, once monthly using the 
appropriate preloaded applicator tube.
    (ii) Indications for use. For the prevention of heartworm disease 
caused by Dirofilaria immitis, as well as the treatment and control of 
intestinal hookworm (Ancylostoma caninum (adult, immature adult, and L4 
larvae) and Uncinaria stenocephala (adult, immature adult, and L4 
larvae)), roundworm (Toxocara canis (adult and L4 larvae) and Toxascaris 
leonina (adult)), and whipworm (Trichuris vulpis (adult)) infections in 
dogs and puppies that are at least 7 weeks of age and that weigh at 
least 3 lbs.
    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

[63 FR 14036, Mar. 24, 1998, as amended at 65 FR 36617, June 9, 2000; 66 
FR 46370, Sept. 5, 2001. Redesignated at 76 FR 48715, Aug. 9, 2011, as 
amended at 80 FR 53460, Sept. 4, 2015; 82 FR 21691, May 10, 2017; 86 FR 
14821, Mar. 19, 2021]



Sec. 524.1465  Mupirocin.

    (a) Specifications. Each gram of ointment contains 20 milligrams 
mupirocin.

[[Page 369]]

    (b) Sponsors. See Nos. 025463, 051672, and 054771 in Sec. 
510.600(c) of this chapter.
    (c) Conditions of use in dogs--(1) Amount. Apply twice daily. 
Treatment should not exceed 30 days.
    (2) Indications for use. For the topical treatment of bacterial 
infections of the skin, including superficial pyoderma, caused by 
susceptible strains of Staphylococcus aureus and S. intermedius.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[72 FR 18119, Apr. 11, 2007, as amended at 75 FR 79296, Dec. 20, 2010; 
78 FR 52854, Aug. 27, 2013; 79 FR 10970, Feb. 27, 2014; 82 FR 11508, 
Feb. 24, 2017]



Sec. 524.1484  Neomycin ophthalmic and topical dosage forms.



Sec. 524.1484b  Neomycin, isoflupredone, and tetracaine powder.

    (a) Specifications. Each 15-gram insufflator bottle contains 5 
milligrams (mg) neomycin sulfate (equivalent to 3.5 mg neomycin base), 1 
mg isoflupredone acetate, and 5 mg tetracaine hydrochloride in a powder 
base.
    (b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in horses, dogs, and cats--(1) Amount. Apply 
to affected areas as a dusting powder.
    (2) Indications for use. For the treatment or as adjunctive therapy 
of certain ear and skin conditions caused by or associated with 
neomycin-susceptible organisms and/or allergy; as a superficial dressing 
applied to minor cuts, wounds, lacerations, abrasions, and for 
postsurgical application where reduction of pain and inflammatory 
response is deemed desirable; as a dusting powder following amputation 
of tails, claws, and dewclaws and following ear trimming, castrating, 
and such surgical procedures as ovariohysterectomies. For the treatment 
of acute otitis externa, acute moist dermatitis, and interdigital 
dermatitis in dogs.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[40 FR 13873, Mar. 27, 1975, as amended at 43 FR 18172, Apr. 28, 1978; 
79 FR 10970, Feb. 27, 2014; 85 FR 45308, July 28, 2020]



Sec. 524.1484c  Neomycin, isoflupredone, and tetracaine ointment.

    (a) Specifications. The drug contains 5 milligrams of neomycin 
sulfate (equivalent to 3.5 milligrams of neomycin base), 1 milligram of 
isoflupredone acetate, and 5 milligrams of tetracaine hydrochloride in 
each gram of ointment.
    (b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in dogs--(1) Amount. In treatment of otitis 
externa and other inflammatory conditions of the external ear canal, a 
quantity of ointment sufficient to fill the external ear canal; may be 
applied one to three times daily. When used on the skin or mucous 
membranes, the affected area should be cleansed, and a small amount of 
the ointment applied and spread or rubbed in gently. The involved area 
may be treated one to three times a day and these daily applications 
continued in accordance with the clinical response.
    (2) Indications for use. For the treatment of acute otitis externa 
in dogs and to a lesser degree, chronic otitis externa in dogs. It also 
is effective in treating anal gland infections and moist dermatitis in 
the dog and is a useful dressing for minor cuts, lacerations, abrasions, 
and post-surgical therapy in the horse, cat, and dog. It may also be 
used following amputation of dewclaws, tails and claws, following ear 
trimming and castrating operations.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[40 FR 13873, Mar. 27, 1975, as amended at 43 FR 18172, Apr. 28, 1978; 
79 FR 10970, Feb. 27, 2014]



Sec. 524.1484d  Neomycin, hydrocortisone, and tetracaine otic ointment.

    (a) Specifications. The product contains 5 milligrams of neomycin 
sulfate, equivalent to 3.5 milligrams of neomycin base, 5 milligrams of 
hydrocortisone acetate, and 5 milligrams of tetracaine hydrochloride in 
each gram of ointment.
    (b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in dogs and cats--(1) Amount. Instill a 
quantity of ointment sufficient to fill the external ear

[[Page 370]]

canal; may be applied one to three times daily.
    (2) Indications for use. For the treatment of ear canker and other 
inflammatory conditions of the external ear canal, acute otitis externa 
and, to a lesser degree, chronic otitis externa.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[40 FR 13873, Mar. 27, 1975, as amended at 49 FR 21922, May 24, 1984; 79 
FR 10970, Feb. 27, 2014]



Sec. 524.1484e  Neomycin and polymyxin B ophthalmic solution.

    (a) Specifications. Each milliliter of the ophthalmic preparation 
contains 5.0 milligrams neomycin sulfate (3.5 milligrams neomycin base), 
and 10,000 Units of polymyxin B sulfate.
    (b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in dogs--(1) Amount. Instill 1 to 2 drops per 
eye every 6 hours.
    (2) Indications for use. For the treatment of bacterial infections 
associated with topical ophthalmological conditions such as corneal 
injuries, superficial keratitis, conjunctivitis, keratoconjunctivitis, 
and blepharitis.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[40 FR 13873, Mar. 27, 1975, as amended at 61 FR 5507, Feb. 13, 1996; 79 
FR 10970, Feb. 27, 2014]



Sec. 524.1484f  Neomycin, prednisolone, and tetracaine otic suspension.

    (a) Specifications. The product contains 5 milligrams of neomycin 
sulfate equivalent to 3.5 milligrams of neomycin base, 2.5 milligrams of 
prednisolone acetate, and 5 milligrams of tetracaine hydrochloride in 
each milliliter of sterile suspension.
    (b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in dogs and cats--(1) Amount. Instill 2 to 6 
drops in the external ear canal 2 or 3 times daily.
    (2) Indications for use. For the treatment of acute otitis externa 
and, to a lesser degree, chronic otitis externa; as treatment or 
adjunctive therapy of certain ear conditions caused by or associated 
with neomycin-susceptible organisms and/or allergy.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[40 FR 13873, Mar. 27, 1975, as amended at 79 FR 10971, Feb. 27, 2014]



Sec. 524.1484g  Neomycin, thiabendazole, and dexamethasone solution.

    (a) Specifications. Each milliliter of solution contains 40 
milligrams (mg) thiabendazole, 3.2 mg neomycin (from neomycin sulfate), 
and 1 mg dexamethasone.
    (b) Sponsors. See Nos. 000010 and 026637 in Sec. 510.600(c) of this 
chapter.
    (c) Conditions of use in dogs and cats--(1) Amount. In treating 
dermatoses affecting areas other than the ear, the surface of the 
lesions should be well moistened (2 to 4 drops per square inch) twice 
daily. In treating otitis externa, instill 5 to 15 drops in the ear 
twice daily. Treat for up to 7 days.
    (2) Indications for use. As an aid in the treatment of bacterial, 
mycotic, and inflammatory dermatoses and otitis externa.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[40 FR 13873, Mar. 27, 1975, as amended at 62 FR 63271, Nov. 28, 1997; 
79 FR 10971, Feb. 27, 2014; 80 FR 61297, Oct. 13, 2015; 84 FR 39184, 
Aug. 9, 2019]



Sec. 524.1484h  Neomycin, penicillin, polymyxin B, and hydrocortisone
suspension.

    (a) Specifications. Each milliliter of suspension contains 25 
milligrams of neomycin sulfate equivalent to 17.5 milligrams of 
neomycin, 10,000 international units of penicillin G procaine, 5,000 
international units of polymyxin B sulfate, 2 milligrams of 
hydrocortisone acetate, and 1.25 milligrams of hydrocortisone sodium 
succinate.
    (b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in dogs--(1) Amount. Rub a small amount into 
the affected area 1 to 3 times a day. After definite improvement, apply 
once daily or every other day.
    (2) Indications for use. For the treatment of summer eczema, atopic 
dermatitis, interdigital eczema, and otitis

[[Page 371]]

externa caused by bacteria susceptible to neomycin, penicillin, and 
polymyxin B.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.
    (d) Conditions of use--dogs--(1) Amount. Rub a small amount into the 
involved area 1 to 3 times a day. After definite improvement, it may be 
applied once a day or every other day.
    (2) Indications for use. Treatment of summer eczema, atopic 
dermatitis, interdigital eczema, and otitis externa caused by bacteria 
susceptible to neomycin, penicillin, and polymyxin B.
    (3) Limitations. For use in dogs only. Shake drug thoroughly and 
clean lesion before using. If redness, irritation, or swelling persists 
or increases, discontinue use and reevaluate diagnosis. Federal law 
restricts this drug to use by or on the order of a licensed 
veterinarian.

[59 FR 5105, Feb. 3, 1994, as amended at 79 FR 10971, Feb. 27, 2014]



Sec. 524.1484i  Neomycin and hydrocortisone ointment.

    (a) Specifications. The drug contains 5 milligrams of neomycin 
sulfate, equivalent to 3.5 milligrams of neomycin base, and 5 milligrams 
of hydrocortisone acetate in each gram of ointment.\1\
    (b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in dogs and cats--(1) Amount. Apply 3 or 4 
times daily into the conjunctival sac. With improvement, frequency may 
be reduced to 2 or 3 times daily. For treatment of ear canker and other 
inflammatory conditions of the external ear canal, fill external ear 
canal 1 to 3 times daily.
    (2) Indications for use. For the treatment of infections, allergic 
and traumatic keratitis, conjunctivitis, acute otitis externa and, to a 
lesser degree, chronic otitis externa.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[43 FR 40456, Sept. 12, 1978, as amended at 79 FR 10971, Feb. 27, 2014]



Sec. 524.1484j  Neomycin and prednisolone ophthalmic ointment.

    (a) Specifications. Each gram of ointment contains prednisolone 
sodium phosphate equivalent to 2.5 milligrams prednisolone 21-phosphate 
and 5 milligrams neomycin sulfate equivalent to 3.5 milligrams neomycin 
base.
    (b) Sponsor. See No. 000010 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in dogs and cats--(1) Amount. A small quantity 
of the ointment should be expressed into the conjunctival sac 4 times a 
day (at intervals of 1 to 8 hours) for a few days until there is a 
favorable response, then the frequency of application may be reduced to 
twice daily as long as the condition remains under control. Treatment 
may require from a few days to several weeks.
    (2) Indications for use. For use in superficial ocular inflammations 
or infections limited to the conjunctiva or the anterior segment of the 
eye, such as those associated with allergic reactions or gross 
irritants.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[79 FR 10971, Feb. 27, 2014, as amended at 84 FR 39184, Aug. 9, 2019]



Sec. 524.1484k  Neomycin and prednisolone suspension.

    (a) Specifications. Each milliliter of suspension contains 2.5 
milligrams of prednisolone acetate and 5 milligrams of neomycin sulfate 
equivalent to 3.5 milligrams of neomycin base.
    (b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in dogs and cats--(1) Amount. For beginning 
treatment of acute ocular inflammations place 1 or 2 drops in the 
conjunctival sac 3 to 6 times during a 24 hour period. When improvement 
occurs, reduce the dosage to 1 drop 2 to 4 times daily. For otitis 
externa, place 2 to 6 drops in the external ear canal 2 or 3 times 
daily.
    (2) Indications for use. For the treatment of treating infectious, 
allergic and traumatic keratitis and conjunctivitis, acute otitis 
externa, and chronic otitis externa.

[[Page 372]]

    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[79 FR 10971, Feb. 27, 2014]



Sec. 524.1580  Nitrofurazone topical dosage forms.



Sec. 524.1580a  Nitrofurazone ointment.

    (a) Specifications. The drug contains 0.2 percent nitrofurazone in a 
water-soluble base.
    (b) Sponsors. See sponsors in Sec. 510.600(c) of this chapter.
    (1) See Nos. 054925, 058005, 059051, 061133, and 069043 for use on 
dogs, cats, or horses.
    (2) See No. 017135 for use on dogs and horses.
    (3) See Nos. 017153 and 058829 for use on horses.
    (c) [Reserved]
    (d) Conditions of use--(1) Amount. Apply directly on the lesion with 
a spatula or first place on a piece of gauze. The preparation should 
remain on the lesion for at least 24 hours. Use of a bandage is 
optional.
    (2) Indications for use. For prevention or treatment of surface 
bacterial infections of wounds, burns, and cutaneous ulcers of dogs, 
cats, or horses.
    (3) Limitations. For use only on dogs, cats, and horses. Do not use 
on horses intended for human consumption. Federal law prohibits the use 
of this product in food-producing animals. In case of deep or puncture 
wounds or serious burns, use only as recommended by veterinarian. If 
redness, irritation, or swelling persists or increases, discontinue use; 
consult veterinarian.

[46 FR 43402, June 27, 1980. Redesignated at 79 FR 10971, Feb. 27, 2014]

    Editorial Note: For Federal Register citations affecting Sec. 
524.1580a, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and at www.govinfo.gov.



Sec. 524.1580b  Nitrofurazone soluble powder.

    (a) Specifications. The drug contains 0.2 percent nitrofurazone in a 
water-soluble base.
    (b) Sponsor. See Nos. 059051 and 069043 in Sec. 510.600(c) of this 
chapter.
    (c) Conditions of use--(1) Amount. Apply several times daily to the 
lesion or affected area from the plastic squeeze bottle.
    (2) Indications for use. For prevention or treatment of surface 
bacterial infections of wounds, burns, skin ulcers, and abscesses after 
incision.
    (3) Limitations. In case of deep or puncture wounds or serious 
burns, use only as recommended by veterinarian. If redness, irritation, 
or swelling persists or increases, discontinue use; consult 
veterinarian. For use only on dogs, cats, and horses (not for food use).

[45 FR 43402, June 27, 1980, as amended at 47 FR 43368, Oct. 1, 1982; 48 
FR 28984, June 24, 1983; 53 FR 40728, Oct. 18, 1988; 54 FR 30542, July 
21, 1989; 56 FR 50653, Oct. 8, 1991; 59 FR 33197, June 28, 1994; 60 FR 
55659, Nov. 2, 1995; 62 FR 35077, June 30, 1997; 76 FR 17778, Mar. 31, 
2011; 78 FR 21060, Apr. 9, 2013. Redesignated at 79 FR 10971, Feb. 27, 
2014, as amended at 79 FR 64117, Oct. 28, 2014; 83 FR 48947, Sept. 28, 
2018]



Sec. 524.1580c  Nitrofurazone and butacaine ointment.

    (a) Specifications. The drug contains 0.2 percent nitrofurazone and 
0.5 percent butacaine sulfate in a water-soluble base.
    (b) Sponsor. See No. 054925 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use--(1) Indications for use. For prevention or 
treatment of surface bacterial infections of ears, wounds, burns, and 
cutaneous ulcers of dogs, cats, and horses.
    (2) Limitations. Apply directly on the lesion with a spatula or 
first place on a piece of gauze. Use of a bandage is optional. The 
preparation should remain on the lesion for at least 24 hours. The 
dressing may be changed several times daily or left on the lesion for a 
longer period. For use only on dogs, cats, and horses (not for food 
use). In case of deep or puncture wounds or serious burns, use only as 
recommended by a veterinarian. If redness, irritation, or swelling 
persists or increases, discontinue use; consult veterinarian.

[49 FR 9417, Mar. 13, 1984, as amended at 71 FR 13542, Mar. 16, 2006. 
Redesignated at 79 FR 10971, Feb. 27, 2014; 79 FR 10971, Feb. 27, 2014]

[[Page 373]]



Sec. 524.1600  Nystatin ophthalmic and topical dosage forms.



Sec. 524.1600a  Nystatin, neomycin, thiostrepton, and triamcinolone
ointment.

    (a) Specifications. Each milliliter of petrolatum base or each gram 
of vanishing cream base ointment contains: 100,000 units of nystatin; 
neomycin sulfate equivalent to 2.5 milligrams of neomycin base; 2,500 
units of thiostrepton; and 1.0 milligram of triamcinolone acetonide.
    (b) Sponsors. For petrolatum base ointments see Nos. 000856, 025463, 
054771, and 054925 in Sec. 510.600(c) of this chapter. For vanishing 
cream base ointments see Nos. 025463, 054771, and 054925.
    (c) Conditions of use--(1) Amount. (i) For topical dermatological 
use: Clean affected areas and remove any encrusted discharge or exudate, 
and apply sparingly either ointment in a thin film.
    (ii) For otic use: Clean ear canal of impacted cerumen, remove any 
foreign bodies such as grass awns and ticks, and instill three to five 
drops of petrolatum base ointment. Preliminary use of a local anesthetic 
may be advisable.
    (iii) For infected anal glands and cystic areas: Drain gland or cyst 
and fill with petrolatum base ointment.
    (2) Indications for use. (i) Topically: Use either ointment in dogs 
and cats for anti-inflammatory, antipruritic, antifungal, and 
antibacterial treatment of superficial bacterial infections, and for 
dermatologic disorders characterized by inflammation and dry or 
exudative dermatitis, particularly associated with bacterial or candidal 
(Candida albicans) infections.
    (ii) Otitis, cysts, and anal gland infections: Use petrolatum base 
ointment in dogs and cats for the treatment of acute and chronic otitis 
and interdigital cysts, and in dogs for anal gland infections.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[40 FR 13873, Mar. 27, 1975, as amended at 43 FR 29770, July 11, 1978; 
50 FR 41490, Oct. 11, 1985; 53 FR 39257, Oct. 6, 1988; 54 FR 5431, Feb. 
3, 1989; 54 FR 48090, Nov. 21, 1989; 56 FR 50653, Oct. 8, 1991; 60 FR 
55660, Nov. 2, 1995; 61 FR 63712, Dec. 2, 1996; 64 FR 42831, Aug. 6, 
1999; 67 FR 67521, Nov. 6, 2002; 68 FR 55201, Sept. 23, 2003; 70 FR 
50183, Aug. 26, 2005; 71 FR 13542, Mar. 16, 2006; 79 FR 10972, Feb. 27, 
2014]



Sec. 524.1600b  Nystatin, neomycin, thiostrepton, and triamcinolone
ophthalmic ointment.

    (a) Specifications. Each cubic centimeter of ointment contains: 
100,000 units of nystatin, neomycin sulfate equivalent to 2.5 milligrams 
of neomycin base, 2,500 units of thiostrepton, and 1.0 milligram of 
triamcinolone acetonide.
    (b) Sponsor. See No. 053501 in Sec. 510.600(c) of this chapter.
    (c) Related tolerances. See Sec. Sec. 556.430 and 556.470 of this 
chapter.
    (d) Conditions of use--(1) Dogs and cats--(i) Amount. Apply 1 drop 
of ointment to the affected eye(s) 2 or 3 times daily. Treatment may be 
continued for up to 2 weeks if necessary.
    (ii) Indications for use. For use as an anti-inflammatory, 
antipruritic, antifungal (Candida albicans), and antibacterial ointment 
for local therapy in keratitis and conjunctivitis.
    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.
    (2) Cattle--(i) Amount. Apply small line of ointment to the affected 
eye(s) once daily. Treatment may be continued for up to 2 weeks if 
necessary.
    (ii) Indications for use. For infectious kerato-conjunctivitis 
(pinkeye).
    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

[40 FR 13873, Mar. 27, 1975, as amended at 50 FR 41490, Oct. 11, 1985; 
79 FR 10972, Feb. 27, 2014; 84 FR 32993, July 11, 2019]



Sec. 524.1610  Orbifloxacin, mometasone furoate monohydrate, 
and posaconazole suspension.

    (a) Specifications. Each gram of suspension contains 10 milligrams 
(mg) orbifloxacin, mometasone furoate monohydrate equivalent to 1 mg

[[Page 374]]

mometasone furoate, and 1 mg posaconazole.
    (b) Sponsor. See No. 000061 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in dogs--(1) Amount. For dogs weighing less 
than 30 lbs. instill 4 drops once daily into the ear canal. For dogs 
weighing 30 lbs. or more, instill 8 drops into the ear canal. Therapy 
should continue for 7 consecutive days.
    (2) Indications for use. For the treatment of otitis externa 
associated with susceptible strains of yeast (Malassezia pachydermatis) 
and bacteria (coagulase-positive staphylococci, Pseudomonas aeruginosa, 
and Enterococcus faecalis).
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[75 FR 16346, Apr. 1, 2010]



Sec. 524.1662  Oxytetracycline ophthalmic and topical dosage forms.



Sec. 524.1662a  Oxytetracycline and hydrocortisone spray.

    (a) Specifications. Each 3-ounce unit of oxytetracycline 
hydrochloride and hydrocortisone spray contains 300 milligrams of 
oxytetracycline hydrochloride and 100 milligrams of hydrocortisone with 
an inert freon propellant such that a 1-second spray treatment will 
deliver approximately 2.5 milligrams of oxytetracycline hydrochloride 
and 0.8 milligram of hydrocortisone.
    (b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in dogs and cats--(1) Amount. A small quantity 
should be sprayed on the affected surface by holding the container about 
6 inches from the area to be treated and pressing the nozzle for 1 or 2 
seconds. Only sufficient spray to coat the skin thinly is necessary. The 
application of small amounts at frequent intervals will give best 
results. Before treating animals with long or matted hair, it may be 
necessary to clip the affected area or spread the hairs to allow the 
medication to contact the skin surface. Relief may be noted following 
the first or second treatment; however, treatment should not be 
discontinued too soon after the initial favorable response has been 
obtained.
    (2) Indications for use. For the relief of discomfort and continued 
treatment of many allergic, infectious, and traumatic skin conditions; 
for the prevention of bacterial infections in superficial wounds, cuts, 
and abrasions, treatment of allergic dermatoses, including urticaria, 
eczemas, insect bites, and cutaneous drug reactions, infections 
associated with minor burns and wounds, and nonspecific pruritus.
    (3) Limitations. Keep away from eyes or other mucous membranes; 
avoid inhaling; use with adequate ventilation; in case of deep or 
puncture wounds or serious burns, consult a veterinarian.

[40 FR 13873, Mar. 27, 1975, as amended at 79 FR 10972, Feb. 27, 2014]



Sec. 524.1662b  Oxytetracycline and polymyxin B ophthalmic 
ointment.

    (a) Specifications. Each gram of the ointment contains 
oxytetracycline hydrochloride equivalent to 5 milligrams of 
oxytetracycline and 10,000 units of polymyxin B sulfate.
    (b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in dogs and cats--(1) Amount. Administer 
topically to the eye two to four times daily.
    (2) Indications for use. For the prophylaxis and local treatment of 
superficial ocular infections due to oxytetracycline- and polymyxin-
sensitive organisms including ocular infections due to streptococci, 
rickettsiae, E. coli, and A. aerogenes (such as conjunctivitis, 
keratitis, pinkeye, corneal ulcer, and blepharitis in dogs, cats, 
cattle, sheep, and horses); ocular infections due to secondary bacterial 
complications associated with distemper in dogs; and ocular infections 
due to bacterial inflammatory conditions which may occur secondary to 
other infectious diseases in dogs, cats, cattle, sheep, and horses.
    (3) Limitations. Allergic reactions may occasionally occur. 
Treatment should be discontinued if reactions are severe. If new 
infections due to nonsensitive bacteria or fungi appear during therapy, 
appropriate measures should be taken.

[40 FR 13873, Mar. 27, 1975, as amended at 79 FR 10972, Feb. 27, 2014]

[[Page 375]]



Sec. 524.1742  Phosmet emulsifiable liquid.

    (a) Specifications. The emulsifiable liquid contains 11.6 percent N-
(mercaptomethyl) phthalimide S-(O,O- dimethyl phosphorodithioate).
    (b) Sponsor. See No. 000061 in Sec. 510.600(c) of this chapter.
    (c) Related tolerances. See 40 CFR 180.261.
    (d) Conditions of use--(1) Methods of application. Methods of 
application to control the following conditions on beef cattle:

                       Table 1 to Paragraph (d)(1)
------------------------------------------------------------------------
                                              Dilution rate (gal. drug:
         To control/method of use                  gal. of water)
------------------------------------------------------------------------
Grubs:
  Dip.....................................  1:60
  Pour-on.................................  1:2
  Spray...................................  1:49
Lice:
  Dip.....................................  1:60
  Pour-on.................................  1:2 or 1:5
  Spray...................................  1:49 or 1:100
Hornflies:
  Dip.....................................  1:60
  Spray...................................  1:49 or 1:100
Cattle Ticks:
  Dip.....................................  1:60 or 1:240
  Spray...................................  1:49
Southern cattle ticks:
  Dip.....................................  1:60 or 1:240
  Spray...................................  1:49
Scabies mites:............................
  Dip.....................................  1:60
Lone Star Ticks:
  Dip.....................................  1:60
  Spray...................................  1:49 or 1:100
------------------------------------------------------------------------

    (i) Dip vat procedure. (A) Prior to charging vat, empty old contents 
and thoroughly clean the vat. Dip vats should be calibrated to maintain 
an accurate dilution. Add water, then drug to the vat according to the 
dilution rate indicated in the table. Add super phosphate at a rate of 
100 pounds per 1,000 gallons of vat solution. Super phosphate is added 
to control the pH of the solution and ensure vat stability. Super 
phosphate is usually available at most fertilizer dealers as 0-45-0 or 
0-46-0. Stir the dip thoroughly, preferably with a compressed air 
device; however, any form of thorough mixing is adequate. Re-stir vat 
contents prior to each use. During the dipping operation, each time the 
dip's volume is reduced by \1/8\ to \1/4\ of its initial volume, 
replenish with water and add the drug at a rate of 1 gallon for each 50 
or 200 gallons water added--depending on dilution rate 1:60 or 1:240. 
Also add super phosphate as necessary to maintain pH between 4.5 and 
6.5. Stir well and resume dipping. Repeat replenishment process as 
necessary. For evaportion, add additional water accordingly. For added 
water due to rainfall, merely replenish dip with the product according 
to directions. If overflow occurs, either analyze for drug concentration 
and adjust accordingly or dispose of vat contents and recharge. Check pH 
after each addition of water or super phosphate to assure proper pH 
controls.
    (B) Dip maintenance. (1) With use of dip vat tester, dipping may 
continue as long as the drug concentration is maintained between 0.15 
and 0.25 percent, and the dip is not too foul for satisfactory use as 
indicated by foul odor or excessive darkening (i.e., color changes from 
beige to very dark brown).
    (2) Without use of dip vat tester, vat should be emptied, cleaned, 
and recharged each time one of the following occurs: When the dip has 
been charged for 120 days; when the dip becomes too foul for 
satisfactory use, within the 120-day limit; if the number of animals 
dipped equals twice the number of gallons of the initial dip volume, 
within the 120-day limit.
    (ii) Spray method. To prepare the spray, mix drug with water 
according to table and stir thoroughly. Apply the fresh mixture as a 
high-pressure spray, taking care to wet the skin, not just the hair. 
Apply to the point of ``runoff,'' about 1 gallon of diluted spray per 
adult animal. Lesser amounts will permit runoff for younger animals.
    (iii) Pour-on method. Dilute the drug with water according to table 
by slowly adding water to the product while stirring. Apply 1 ounce of 
the diluted mixture per 100 pounds of body weight (to a maximum of 8 
ounces per head) down the center line of the back.
    (2) Timing of applications for cattle grub control. For optimum 
cattle grub control, it is important to treat as soon as possible after 
the heel fly season, before the grub larvae reach the gullet or spinal 
canal, as the rapid kill of large numbers of larvae in these tissues may 
cause toxic side effects, such as bloat, salivation, staggering, and 
paralysis.

[[Page 376]]

    (3) Treatment regimens. (i) Control of scabies mites requires two 
treatments, 10 to 14 days apart.
    (ii) Control of Lone Star Ticks and hornflies requires two 
treatments, 7 days apart.
    (4) Warnings. The drug is a cholinesterase inhibitor. Do not use 
this drug on animals simultaneously or within a few days before or after 
treatment with or exposure to cholinesterase-inhibiting drugs, 
pesticides, or chemicals. Do not apply within 21 days of slaughter. For 
use on beef cattle only. Do not treat sick, convalescent, or stressed 
cattle, or calves less than 3 months old except in Federal or State 
eradication programs where immediate treatment of all animals in an 
infested herd is mandatory. Be sure free access to drinking water is 
available to cattle prior to dipping. Do not dip excessively thirsty 
animals. Do not dip animals when overheated. Repeat treatment as 
necessary but not more often than every 7 to 10 days. Treatment for 
lice, ticks, hornflies, and scabies mites may be made any time of the 
year except when cattle grub larvae are in the gullet or spinal canal. 
Treatment for lice, ticks, and scabies mites may be made any time 7 to 
10 days following treatment for grubs. Do not treat grubs when the grub 
larvae are in the gullet or spinal canal. Do not get in eyes, on skin, 
or on clothing. Do not breathe spray mist. Wear rubber gloves, goggles, 
and protective clothing. In case of skin contact, wash immediately with 
soap and water; for eyes, flush with water. Wash all contaminated 
clothing with soap and hot water before re-use.

[40 FR 13873, Mar. 27, 1975, as amended at 46 FR 27914, May 22, 1981; 48 
FR 39607, Sept. 1, 1983; 54 FR 51021, Dec. 12, 1989; 61 FR 8873, Mar. 6, 
1996; 62 FR 61626, Nov. 19, 1997; 63 FR 5255, Feb. 2, 1998; 85 FR 18120, 
Apr. 1, 2020]



Sec. 524.1982  Proparacaine ophthalmic solution.

    (a) Specifications. The drug is an aqueous solution containing 0.5 
percent proparacaine hydrochloride, 2.45 percent glycerin as a 
stabilizer, and 0.2 percent chlorobutanol (choral derivative) and 
1:10,000 benzalkonium chloride as preservatives.
    (b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in dogs and cats--(1) Amount. It is 
administered as follows:
    (i) For removal of sutures: Instill one to two drops 2 or 3 minutes 
before removal of stitches.
    (ii) For removal of foreign bodies from eye, ear, and nose: For 
ophthalmic use, instill three to five drops in the eye prior to 
examination; for otic use, instill five to ten drops in the ear; for 
nasal use, instill five to ten drops in each nostril every 3 minutes for 
three doses.
    (iii) For tonometry: Instill one to two drops immediately before 
measurement.
    (iv) As an aid in treatment of otitis: Instill two drops into the 
ear every 5 minutes for three doses.
    (v) For minor surgery: Instill one or more drops as required.
    (vi) For catheterization: Instill two to three drops with a blunt 
20-gauge needle immediately before inserting catheter.
    (2) Indications for use. For use as a topical ophthalmic anesthetic. 
It is used as an anesthetic in cauterization of corneal ulcers, removal 
of foreign bodies and sutures from the cornea, and measurement of 
intraocular pressure (tonometry) when glaucoma is suspected; as an aid 
in the removal of foreign bodies from the nose and ear canal; as an 
accessory in the examination and treatment of painful otitis, in minor 
surgery, and prior to catheterization.
    (3) Limitations. Keep away from eyes or other mucous membranes; 
avoid inhaling; use with adequate ventilation; in case of deep or 
puncture wounds or serious burns, consult a veterinarian.
    (d) Conditions of use. (1) The drug is indicated for use as a 
topical ophthalmic anesthetic in animals. It is used as an anesthetic in 
cauterization of corneal ulcers, removal of foreign bodies and sutures 
from the cornea, and measurement of intraocular pressure (tonometry) 
when glaucoma is suspected. Local applications may also be used as an 
aid in the removal of foreign bodies from the nose and ear canal, as an 
accessory in the examination and treatment of painful otitis, in minor 
surgery, and prior to catheterization.

[[Page 377]]

    (2) It is administered as follows:
    (i) For removal of sutures: Instill one to two drops 2 or 3 minutes 
before removal of stitches.
    (ii) For removal of foreign bodies from eye, ear, and nose: For 
ophthalmic use, instill three to five drops in the eye prior to 
examination; for otic use, instill five to 10 drops in the ear; for 
nasal use, instill five to 10 drops in each nostril every 3 minutes for 
three doses.
    (iii) For tonometry: Instill one to two drops immediately before 
measurement.
    (iv) As an aid in treatment of otitis: Instill two drops into the 
ear every 5 minutes for three doses.
    (v) For minor surgery: Instill one or more drops as required.
    (vi) For catheterization: Instill two to three drops with a blunt 
20-gauge needle immediately before inserting catheter.
    (3) For use only by or on the order of a licensed veterinarian.

[40 FR 13873, Mar. 27, 1975, as amended at 50 FR 41490, Oct. 11, 1985; 
79 FR 10972, Feb. 27, 2014]



Sec. 524.2080  Ropinirole.

    (a) Specifications. Each milliliter of solution contains 30 
milligrams (mg) ropinirole (equivalent to 34.2 mg ropinirole 
hydrochloride).
    (b) Sponsor. See No. 052483 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use--(1) Amount. Using the table provided in 
labeling, administer the number of eye drops topically, corresponding to 
body weight, that results in a target dose of 3.75 mg per square meter 
(mg/m\2\) (dose band 2.7 to 5.4 mg/m\2\). If the dog does not vomit 
within 20 minutes of the first dose, then a second dose may be 
administered.
    (2) Indications for use. For the induction of vomiting in dogs.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[86 FR 13185, Mar. 8, 2021]



Sec. 524.2098  Selamectin.

    (a) Specifications. Each milliliter contains 60 or 120 milligrams 
(mg) of selamectin.
    (b) Sponsors. See Nos. 054771, 055529, 061133, and 061651 in Sec. 
510.600(c) of this chapter.
    (c) Conditions of use--(1) Amount. Administer topically 2.7 mg of 
selamectin per pound (6 mg per kilogram) of body weight.
    (2) Indications for use. Kills adult fleas and prevents flea eggs 
from hatching for 1 month, and it is indicated for the prevention and 
control of flea infestations (Ctenocephalides felis), prevention of 
heartworm disease caused by Dirofilaria immitis, and treatment and 
control of ear mite (Otodectes cynotis) infestations in dogs and cats. 
Treatment and control of sarcoptic mange (Sarcoptes scabiei) and control 
of tick (Dermacentor variabilis) infestations in dogs. Treatment and 
control of intestinal hookworm (Ancylostoma tubaeforme) and roundworm 
(Toxocara cati) infections in cats. For dogs 6 weeks of age and older, 
and cats 8 weeks of age and older.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[64 FR 37401, July 12, 1999, as amended at 64 FR 48707, Sept. 8, 1999; 
65 FR 45282, July 21, 2000; 74 FR 19878, Apr. 30, 2009; 79 FR 10972, 
Feb. 27, 2014; 85 FR 18120, Apr. 1, 2020; 85 FR 45308, July 28, 2020; 86 
FR 13185, Mar. 8, 2021; 86 FR 17064, Apr. 1, 2021]



Sec. 524.2099  Selamectin and sarolaner.

    (a) Specifications. Each milliliter (mL) of solution contains 60 
milligrams (mg) selamectin and 10 mg sarolaner. The drug is provided in 
single dose tubes containing 0.25, 0.5, or 1 mL of solution.
    (b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in cats--(1) Amount. Administer 2.7 mg 
selamectin per pound (/lb) (6 mg per kilogram (/kg)) of body weight and 
0.45 mg/lb sarolaner (1 mg/kg) by emptying the contents of the tube on 
the back of the animal at the base of the neck in front of the shoulder 
blades.
    (2) Indications for use. For the prevention of heartworm disease 
caused by Dirofilaria immitis. Kills adult fleas (Ctenocephalides felis) 
and is indicated for the treatment and prevention of flea infestations; 
the treatment and control of tick infestations with Ixodes

[[Page 378]]

scapularis (black-legged or deer tick), Amblyomma maculatum (Gulf Coast 
tick), and Dermacentor variabilis (American dog tick); the treatment and 
control of ear mite (Otodectes cynotis) infestations; and the treatment 
and control of roundworm (Toxocara cati) and intestinal hookworm 
(Ancylostoma tubaeforme) infections in cats and kittens 8 weeks of age 
and older, and weighing 2.8 pounds or greater.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[84 FR 12494, Apr. 2, 2019]



Sec. 524.2101  Selenium disulfide suspension.

    (a) Specifications. The product contains 0.9-percent weight in 
weight (w/w) selenium disulfide (1-percent weight in volume (w/v)).
    (b) Sponsors. See Nos. 000010, 000061, and 017135 in Sec. 
510.600(c) of this chapter.
    (c) Conditions of use on dogs--(1) Indications for use. For use as a 
cleansing shampoo and as an agent for removing skin debris associated 
with dry eczema, seborrhea, and nonspecific dermatoses.
    (2) Amount. One to 2 ounces per application.
    (3) Limitations. Use carefully around scrotum and eyes, covering 
scrotum with petrolatum. Allow the shampoo to remain for 5 to 15 minutes 
before thorough rinsing. Repeat treatment once or twice a week. If 
conditions persist or if rash or irritation develops, discontinue use 
and consult a veterinarian.

[47 FR 53351, Nov. 26, 1982, as amended at 48 FR 32762, July 19, 1983; 
54 FR 36962, Sept. 6, 1989; 56 FR 9623, Mar. 7, 1991; 58 FR 41025, Aug. 
2, 1993; 63 FR 26981, May 15, 1998; 70 FR 50183, Aug. 26, 2005; 84 FR 
39184, Aug. 9, 2019]



Sec. 524.2350  Tolnaftate cream.

    (a) Specifications. The drug contains 1 percent tolnaftate in an 
anhydrous cream base.
    (b) Sponsor. See No. 000061 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use--(1) Amount. Apply a small amount of the cream 
to the affected areas once or twice a day for 2 to 4 weeks.
    (2) Indications for use. For the treatment of ringworm lesions due 
to Microsporum canis and Microsporum gypseum.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[79 FR 10972, Feb. 27, 2014]



Sec. 524.2482  Triamcinolone spray.

    (a) Specifications. Each milliliter of solution contains 0.15 
milligrams triamcinolone acetonide.
    (b) Sponsor. See No. 051311 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in dogs--(1) Amount. Apply sufficient pump 
sprays to uniformly and thoroughly wet the affected areas while avoiding 
run off of excess product. Administer twice daily for 7 days, then once 
daily for 7 days, then every other day for an additional 14 days (28 
days total).
    (2) Indications for use. For the control of pruritus associated with 
allergic dermatitis.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[68 FR 4916, Jan. 31, 2003, as amended at 78 FR 17868, Mar. 25, 2013]



Sec. 524.2483  Triamcinolone cream.

    (a) Specifications. The vanishing cream contains 0.1 percent 
triamcinolone acetonide.
    (b) Sponsor. See Nos. 000010 and 054925 in Sec. 510.600(c) of this 
chapter.
    (c) Conditions of use in dogs--(1) Amount. Rub into affected areas 
two to four times daily for 4 to 10 days.
    (2) Indications for use. For topical treatment of allergic 
dermatitis and summer eczema.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[71 FR 13542, Mar. 16, 2006, as amended at 73 FR 79318, Dec. 29, 2008. 
Redesignated and amended at 75 FR 10168, Mar. 5, 2010; 77 FR 60302, Oct. 
3, 2012]



Sec. 524.2620  Liquid crystalline trypsin, Peru balsam, castor oil.

    (a) Specifications. (1) Each gram of liquid or aerosol contains 0.12 
milligram of crystalline trypsin, 87.0 milligrams of Peru balsam, and 
788.0 milligrams of castor oil.
    (2) Each gram of liquid or aerosol contains 0.1 milligram of 
crystalline

[[Page 379]]

trypsin, 72.5 milligrams of Peru balsam, and 800 milligrams of castor 
oil.
    (b) Sponsors. See sponsor numbers in Sec. 510.600(c) of this 
chapter for use as in paragraph (c) in this section:
    (1) No. 051079 for use of product described in paragraph (a)(1).
    (2) No. 017135 for use of product described in paragraph (a)(2).
    (c) Conditions of use--(1) Amount. Apply directly to the wound site.
    (2) Indications for use. As an aid in the treatment of external 
wounds and assists healing by facilitating the removal of necrotic 
tissue, exudate, and organic debris.

[79 FR 10973, Feb. 27, 2014]



PART 526_INTRAMAMMARY DOSAGE FORM NEW ANIMAL DRUGS--Table of Contents



Sec.
526.88 Amoxicillin.
526.313 Ceftiofur.
526.363 Cephapirin benzathine.
526.365 Cephapirin sodium.
526.464 Cloxacillin benzathine.
526.465 Cloxacillin sodium.
526.820 Erythromycin.
526.1130 Hetacillin.
526.1590 Novobiocin.
526.1696 Penicillin G procaine.
526.1697 Penicillin G procaine and dihydrostreptomycin.
526.1698 Penicillin G procaine and novobiocin.
526.1810 Pirlimycin.

    Authority: 21 U.S.C. 360b.



Sec. 526.88  Amoxicillin.

    (a) Specifications. Each single-dose, 10-milliliter syringe contains 
amoxicillin trihydrate equivalent to 62.5 milligrams (mg) amoxicillin.
    (b) Sponsor. See No. 000061 in Sec. 510.600(c) of this chapter.
    (c) Related tolerances. See Sec. 556.38 of this chapter.
    (d) Conditions of use in lactating cows--(1) Amount. Infuse the 
contents of one syringe (equivalent to 62.5 mg amoxicillin) into each 
infected quarter every 12 hours for a maximum of 3 doses.
    (2) Indications for use. For the treatment of subclinical infectious 
bovine mastitis due to Streptococcus agalactiae and Straphylococcus 
aureus (penicillin sensitive).
    (3) Limitations. Milk taken from animals during treatment and for 60 
hours (5 milkings) after the last treatment must not be used for food. 
Treated animals must not be slaughtered for food purposes within 12 days 
after the last treatment. Federal law restricts this drug to use by or 
on the order of a licensed veterinarian.

[57 FR 37334, Aug. 18, 1992, as amended at 60 FR 55660, Nov. 2, 1995; 68 
FR 44878, July 31, 2003; 86 FR 13185, Mar. 8, 2021]



Sec. 526.313  Ceftiofur.

    (a) Specifications. Each single-dose, 10-milliliter syringe 
contains:
    (1) 125 milligrams (mg) ceftiofur equivalents as the hydrochloride 
salt; or
    (2) 500 mg ceftiofur equivalents as the hydrochloride salt.
    (b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
    (c) Related tolerances. See Sec. 556.113 of this chapter.
    (d) Conditions of use for syringe described in paragraph (a)(1) of 
this section in lactating cows--(1) Amount. Infuse the contents of one 
syringe (125 mg ceftiofur equivalents) into each affected quarter. 
Repeat treatment in 24 hours. Once daily treatment may be repeated for 
up to 8 consecutive days.
    (2) Indications for use. For the treatment of clinical mastitis 
associated with coagulase-negative staphylococci, Streptococcus 
dysgalactiae, and Escherichia coli; and the treatment of diagnosed 
subclinical mastitis associated with coagulase-negative staphylococci 
and S. dysgalactiae.
    (3) Limitations. Milk taken from cows during treatment (a maximum of 
8 daily infusions) and for 72 hours after the last treatment must not be 
used for human consumption. Following label use for up to 8 consecutive 
days, a 2-day preslaughter withdrawal period is required. Federal law 
restricts this drug to use by or on the order of a licensed 
veterinarian.
    (4) Special considerations. Federal law prohibits extralabel use of 
this drug in lactating dairy cattle for disease prevention purposes; at 
unapproved doses; frequencies, durations, or routes of administration; 
and in unapproved major food-producing species/production classes.

[[Page 380]]

    (e) Conditions of use for syringe described in paragraph (a)(2) of 
this section in dry cows--(1) Amount. Infuse the contents of one syringe 
(500 mg ceftiofur equivalents) into each affected quarter at the time of 
dry off.
    (2) Indications for use. For the treatment of subclinical mastitis 
in dairy cattle at the time of dry off associated with Staphylococcus 
aureus, Streptococcus dysgalactiae, and Streptococcus uberis.
    (3) Limitations. Milk taken from cows completing a 30-day dry-off 
period may be used for food with no milk discard due to ceftiofur 
residues. Following intramammary infusion, a 16-day preslaughter 
withdrawal period is required for treated cows. No preslaughter 
withdrawal period is required for neonatal calves from treated cows 
regardless of colostrum consumption. Federal law restricts this drug to 
use by or on the order of a licensed veterinarian.
    (4) Special considerations. Federal law prohibits extralabel use of 
this drug in dry dairy cattle for disease prevention purposes; at 
unapproved doses; frequencies, durations, or routes of administration; 
and in unapproved major food-producing species/production classes.

[70 FR 9516, Feb. 28, 2005, as amended at 70 FR 20048, Apr. 18, 2005. 
Redesignated and amended at 71 FR 39545, July 13, 2006; 79 FR 10973, 
Feb. 27, 2013; 79 FR 18159, Apr. 1, 2014; 80 FR 34279, June 16, 2015; 86 
FR 13185, Mar. 8, 2021]



Sec. 526.363  Cephapirin benzathine.

    (a) Specifications. Each single-dose, 10-milliliter syringe contains 
300 milligrams cephapirin activity (as cephapirin benzathine).
    (b) Sponsor. See No. 000010 in Sec. 510.600(c) of this chapter.
    (c) Related tolerances. See Sec. 556.115 of this chapter.
    (d) Conditions of use in dry cows--(1) Amount. Infuse the contents 
of one syringe (300 mg cephapirin activity) into each quarter following 
last milking, but no later than 30 days before calving.
    (2) Indications for use. For the treatment of mastitis caused by 
susceptible strains of Streptococcus agalactiae and Staphylococcus 
aureus, including penicillin-resistant strains.
    (3) Limitations. For use in dry cows only. Milk from treated cows 
must not be used for food during the first 72 hours after calving. 
Animals infused with this product must not be slaughtered for food until 
42 days after the latest infusion.

[43 FR 37174, Aug. 22, 1978, as amended at 53 FR 27851, July 25, 1988; 
73 FR 12262, Mar. 7, 2008; 75 FR 10168, Mar. 5, 2010; 76 FR 17338, Mar. 
29, 2011; 86 FR 13186, Mar. 8, 2021]



Sec. 526.365  Cephapirin sodium.

    (a) Specifications. Each single-dose, 10-milliliter syringe contains 
200 milligrams (mg) cephapirin sodium activity.
    (b) Sponsor. See No. 000010 in Sec. 510.600(c) of this chapter.
    (c) Related tolerances. See Sec. 556.115 of this chapter.
    (d) Conditions of use in lactating cows--(1) Amount. Infuse the 
contents of one syringe (200 mg cephapirin activity) into each infected 
quarter immediately after the quarter has been completely milked out. Do 
not milk out for 12 hours. Repeat once only in 12 hours.
    (2) Indications for use. For the treatment of mastitis in lactating 
cows caused by susceptible strains of Streptococcus agalactiae and 
Staphylococcus aureus including strains resistant to penicillin.
    (3) Limitations. If improvement is not noted within 48 hours after 
treatment, consult your veterinarian. Milk that has been taken from 
animals during treatment and for 96 hours after the last treatment must 
not be used for food. Treated animals must not be slaughtered for food 
until 4 days after the last treatment.

[40 FR 57455, Dec. 10, 1975, as amended at 53 FR 27852, July 25, 1988. 
Redesignated at 63 FR 8349, Feb. 19, 1998; 65 FR 20733, Apr. 18, 2000; 
73 FR 3181, Jan. 17, 2008; 75 FR 10168, Mar. 5, 2010; 86 FR 13186, Mar. 
8, 2021]



Sec. 526.464  Cloxacillin benzathine.

    (a) Specifications. Each single-dose, 7.5- or 10-milliliter syringe 
contains cloxacillin benzathine equivalent to 500 milligrams (mg) 
cloxacillin.
    (b) Sponsor. See No. 000010 in Sec. 510.600(c) of this chapter.
    (c) Related tolerances. See Sec. 556.165 of this chapter.

[[Page 381]]

    (d) Conditions of use in dry cows--(1) Amount. Infuse the contents 
of one syringe (equivalent to 500 mg cloxacillin) into each quarter 
immediately after last milking, but no later than 30 days before 
calving.
    (2) Indications for use. For the treatment of mastitis caused by 
Staphylococcus aureus and Streptococcus agalactiae including penicillin 
resistant strains in dairy cows during the dry period.
    (3) Limitations. Animals infused with this product must not be 
slaughtered for food until 30 days after the latest infusion. Federal 
law restricts this drug to use by or on the order of a licensed 
veterinarian.

[86 FR 13186, Mar. 8, 2021]



Sec. 526.465  Cloxacillin sodium.

    (a) Specifications. Each single-dose, 10-milliliter syringe contains 
cloxacillin sodium equivalent to 200 milligrams (mg) cloxacillin.
    (b) Sponsor. See No. 000061 in Sec. 510.600(c) of this chapter.
    (c) Related tolerances. See Sec. 556.165 of this chapter.
    (d) Conditions of use in lactating cows--(1) Amount. Infuse the 
contents of one syringe (equivalent to 200 mg cloxacillin) into each 
infected quarter. Treatment should be repeated at 12-hour intervals for 
a total of 3 doses.
    (2) Indications for use. For the treatment of mastitis in lactating 
cows due to Streptococcus agalactiae and Staphylococcus aureus, 
nonpenicillinase-producing strains.
    (3) Limitations. Milk taken from treated animals within 48 hours (4 
milkings) after the latest treatment should not be used for food. 
Treated animals should not be slaughtered for food within 10 days after 
the latest treatment. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

[57 FR 37335, Aug. 18, 1992, as amended at 60 FR 55660, Nov. 2, 1995; 68 
FR 44878, July 31, 2003. Redesignated at 85 FR 18120, Apr. 1, 2020. 
Redesignated and amended at 86 FR 13186, Mar. 8, 2021]



Sec. 526.820  Erythromycin.

    (a) Specifications. (1) Each single-dose, 6-milliliter (mL) syringe 
contains 300 milligrams (mg) erythromycin (as the base).
    (2) Each single-dose, 12-mL syringe contains 600 mg erythromycin (as 
the base).
    (b) Sponsors. See Nos. 054771 and 061133 in Sec. 510.600(c) of this 
chapter.
    (c) Related tolerances. See Sec. 556.230 of this chapter.
    (d) Conditions of use for syringe described in paragraph (a)(1) of 
this section in lactating cows--(1) Amount. Infuse the contents of one 
6-mL syringe (300 mg erythromycin base) into each infected quarter. 
Repeat infusion at 12-hour intervals for a maximum of 3 infusions.
    (2) Indications for use. For the treatment of mastitis due to 
Staphylococcus aureus, Streptococcus agalactiae, Streptococcus 
dysgalactiae, and Streptococcus uberis in lactating cows.
    (3) Limitations. Milk taken from animals during treatment and for 36 
hours (3 milkings) after the latest treatment must not be used for food.
    (e) Conditions of use for syringe described in paragraph (a)(2) of 
this section in dry cows--(1) Amount. Infuse the contents of one 12-mL 
syringe (600 mg erythromycin base) into each infected quarter at the 
time of drying off.
    (2) Indications for use. For the treatment of mastitis due to 
Staphylococcus aureus, Streptococcus agalactiae, Streptococcus 
dysgalactiae, and Streptococcus uberis in dry cows.
    (3) Limitations. For use in dry cows only.

[86 FR 13186, Mar. 8, 2021]



Sec. 526.1130  Hetacillin.

    (a) Specifications. Each single-dose, 10-milliliter syringe contains 
hetacillin potassium equivalent of 62.5 milligrams (mg) ampicillin.
    (b) Sponsor. See No. 000010 in Sec. 510.600(c) of this chapter.
    (c) Related tolerances. See Sec. 556.316 of this chapter.
    (d) Conditions of use in lactating cows--(1) Amount. Infuse the 
contents of one syringe (equivalent to 62.5 mg ampicillin) into each 
infected quarter. Repeat at 24-hour intervals for a maximum of 3 
treatments.
    (2) Indications for use. For the treatment of acute, chronic, or 
subclinical mastitis in lactating cows caused by susceptible strains of 
Streptococcus

[[Page 382]]

agalactiae, Streptococcus dysgalactiae, Staphylococcus aureus, and 
Escherichia coli.
    (3) Limitations. Milk that has been taken from animals during 
treatment and for 72 hours (6 milkings) after the latest treatment must 
not be used for food. Treated animals must not be slaughtered for food 
until 10 days after the latest treatment. Federal law restricts this 
drug to use by or on the order of a licensed veterinarian.

[57 FR 37335, Aug. 18, 1992, as amended at 75 FR 10168, Mar. 5, 2010; 84 
FR 53311, Oct. 7, 2019; 86 FR 13186, Mar. 8, 2021]



Sec. 526.1590  Novobiocin.

    (a) Specifications. Each single-dose, 10-milliliter syringe 
contains:
    (1) 150 milligrams (mg) of novobiocin equivalents as sodium 
novobiocin, or
    (2) 400 mg of novobiocin equivalents as sodium novobiocin.
    (b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
    (c) Related tolerances. See Sec. 556.460 of this chapter.
    (d) Conditions of use for syringe described in paragraph (a)(1) of 
this section in lactating cows--(1) Amount. Infuse the contents of one 
syringe (equivalent to 150 mg novobiocin) into each infected quarter 
after milking. Repeat treatment once after 24 hours. Do not milk for at 
least 6 hours after treatment.
    (2) Indications for use. For the treatment of mastitis caused by 
susceptible strains of Staphylococcus aureus in lactating cows.
    (3) Limitations. Milk taken from treated animals within 72 hours (6 
milkings) after latest treatment should not be used for food. Do not 
slaughter treated animals for food for 15 days following latest 
treatment. Federal law restricts this drug to use by or on the order of 
a licensed veterinarian.
    (e) Conditions of use for syringe described in paragraph (a)(2) of 
this section in dry cows--(1) Amount. Infuse the contents of one syringe 
(equivalent to 400 mg novobiocin) into each quarter at the time of 
drying off.
    (2) Indications for use. For the treatment of mastitis caused by 
susceptible strains of Staphylococcus aureus and Streptococcus 
agalactiae in dry cows.
    (3) Limitations. For udder installation for the treatment of 
mastitis in dry cows only. Infuse each quarter at the time of drying 
off, but not less than 30 days prior to calving. Do not slaughter 
treated animals for food for 30 days following udder infusion.

[86 FR 13187, Mar. 8, 2021]



Sec. 526.1696  Penicillin G procaine.

    (a) Specifications. Each single-dose, 10-milliliter syringe contains 
penicillin G procaine equivalent to 100,000 units of penicillin G.
    (b) Sponsors. See Nos. 010515 and 061133 in Sec. 510.600(c) of this 
chapter.
    (c) Related tolerances. See Sec. 556.510 of this chapter.
    (d) Conditions of use in lactating cows--(1) Amount. Infuse the 
contents of one 10-milliliter syringe (equivalent to 100,000 units 
penicillin G) into each infected quarter. Treatment may be repeated at 
12-hour intervals for not more than 3 doses, as indicated by clinical 
response.
    (2) Indications for use. For the treatment of mastitis caused by 
Streptococcus agalactiae, S. dysgalactiae, and S. uberus in lactating 
cows.
    (3) Limitations. For intramammary infusion in lactating cows only. 
Discard all milk for 60 hours (5 milkings) after the latest treatment. 
Animals intended for human consumption must not be slaughtered within 3 
days of latest treatment.
    (e) Conditions of use in dry cows--(1) Amount. Infuse the contents 
of one 10-milliliter syringe (equivalent to 100,000 units penicillin G) 
into each infected quarter at time of drying-off.
    (2) Indications for use. For the treatment of mastitis caused by 
Streptococcus agalactiae in dry cows.
    (3) Limitations. For intramammary infusion in dry cows only. Animals 
intended for human consumption must not be slaughtered within 14 days of 
last treatment. Discard all milk for 72 hours (6 milkings) following 
calving, or later as indicated by the marketable quality of the milk.

[86 FR 13187, Mar. 8, 2021]



Sec. 526.1697  Penicillin G procaine and dihydrostreptomycin.

    (a) Specifications. Each single-use, 10-milliliter syringe contains 
a suspension of:

[[Page 383]]

    (1) Penicillin G procaine equivalent to 200,000 units penicillin G 
and dihydrostreptomycin sulfate equivalent to 300 milligrams 
dihydrostreptomycin; or
    (2) Penicillin G procaine equivalent to 1 million units penicillin G 
and dihydrostreptomycin sulfate equivalent to 1 gram 
dihydrostreptomycin.
    (b) Sponsor. See No. 042791 in Sec. 510.600(c) of this chapter.
    (c) Related tolerances. See Sec. Sec. 556.200 and 556.510 of this 
chapter.
    (d) Conditions of use for syringe described in paragraph (a)(1) of 
this section in dry cows--(1) Amount. Infuse the contents of one syringe 
(equivalent to 200,000 units penicillin G and 300 milligrams 
dihydrostreptomycin) into each quarter at the last milking prior to 
drying off.
    (2) Indications for use. For the treatment of subclinical mastitis 
in dairy cows at the time of drying off, specifically against infections 
caused by Staphylococcus aureus and Streptococcus agalactiae.
    (3) Limitations. For use in dry cows only. Not to be used within 6 
weeks of calving. Milk taken from cows within 24 hours (2 milkings) 
after calving must not be used for food. Animals infused with this drug 
must not be slaughtered for food within 60 days of treatment or within 
24 hours after calving.
    (e) Conditions of use for syringe described in paragraph (a)(2) of 
this section in dry cows--(1) Amount. Infuse the contents of one syringe 
(equivalent to 1 million units penicillin G and 1 gram 
dihydrostreptomycin) into each quarter at the last milking prior to 
drying off.
    (2) Indications for use. To reduce the frequency of existing 
infection and to prevent new infections with Staphylococcus aureus in 
dry cows.
    (3) Limitations. Not for use in lactating cows. Not to be used 
within 6 weeks of calving. Milk taken from cows within 96 hours (8 
milkings) after calving must not be used for food. Animals infused with 
this drug must not be slaughtered for food within 60 days from the time 
of infusion or within 96 hours after calving. Federal law restricts this 
drug to use by or on the order of a licensed veterinarian.

[57 FR 37336, Aug. 18, 1992, as amended at 78 FR 21060, Apr. 9, 2013; 83 
FR 14587, Apr. 5, 2018. Redesignated and amended at 86 FR 13187, Mar. 8, 
2021]



Sec. 526.1698  Penicillin G procaine and novobiocin.

    (a) Specifications. Each single-use, 10-milliliter syringe contains 
a suspension of:
    (1) Penicillin G procaine equivalent to 100,000 units penicillin G 
and 150 milligrams (mg) novobiocin as novobiocin sodium; or
    (2) Penicillin G procaine equivalent to 200,000 units penicillin G 
and 400 mg novobiocin as novobiocin sodium.
    (b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
    (c) Related tolerances. See Sec. Sec. 556.460 and 556.510 of this 
chapter.
    (d) Conditions of use for syringe described in paragraph (a)(1) of 
this section in lactating cows--(1) Amount. Infuse the contents of one 
syringe (equivalent to 100,000 units penicillin G and 150 mg novobiocin) 
into each infected quarter after milking. Repeat once after 24 hours.
    (2) Indications for use. For the treatment of mastitis caused by 
susceptible strains of Staphylococcus aureus, Streptococcus agalactiae, 
Streptococcus dysgalactiae, and Streptococcus uberis in lactating cows.
    (3) Limitations. For udder instillation in lactating cows only. Do 
not milk for at least 6 hours after treatment; thereafter, milk at 
regular intervals. Milk taken from treated animals within 72 hours (6 
milkings) after the latest treatment must not be used for food. Treated 
animals must not be slaughtered for food for 15 days following the 
latest treatment. If redness, swelling, or abnormal milk persists, 
discontinue use and consult a veterinarian.
    (e) Conditions of use for syringe described in paragraph (a)(2) of 
this section in lactating cows--(1) Amount. Infuse the contents of one 
syringe (equivalent to 200,000 units penicillin G and 400 mg novobiocin) 
into each quarter at dry off.
    (2) Indications for use. For the treatment of subclinical mastitis 
caused by susceptible strains of Staphylococcus

[[Page 384]]

aureus and Streptococcus agalactiae in dry cows.
    (3) Limitations. For udder instillation in dry cows only. Do not use 
less than 30 days prior to calving. Milk from treated cows must not be 
used for food during the first 72 hours after calving. Treated animals 
must not be slaughtered for food for 30 days following udder infusion.

[57 FR 37336, Aug. 18, 1992; 57 FR 42623, Sept. 15, 1992; 79 FR 10973, 
Feb. 27, 2014; 84 FR 32993, July 11, 2019. Redesignated and amended at 
86 FR 13187, Mar. 8, 2021]



Sec. 526.1810  Pirlimycin.

    (a) Specifications. Each single-dose, 10-milliliter syringe contains 
50 milligrams (mg) of pirlimycin (as pirlimycin hydrochloride).
    (b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
    (c) Related tolerances. See Sec. 556.515 of this chapter.
    (d) Conditions of use in lactating cows--(1) Amount. Infuse the 
contents of one syringe (50 mg pirlimycin) into each infected quarter. 
Daily treatment may be repeated at 24-hour intervals for up to 8 
consecutive days.
    (2) Indications for use. For the treatment of clinical and 
subclinical mastitis in lactating dairy cattle associated with 
Staphylococcus species such as Staphylococcus aureus and Streptococcus 
species such as Streptococcus agalactiae, Streptococcus dysgalactiae, 
and Streptococcus uberis.
    (3) Limitations. Milk taken from animals during treatment and for 36 
hours following the last treatment must not be used for food regardless 
of treatment duration. Following infusion twice at a 24-hour interval, 
treated animals must not be slaughtered for 9 days. Following any 
extended duration of therapy (infusion longer than twice at a 24-hour 
interval, up to 8 consecutive days), animals must not be slaughtered for 
21 days. Federal law restricts this drug to use by or on the order of a 
licensed veterinarian.

[58 FR 58486, Nov. 2, 1993, as amended at 65 FR 61091, Oct. 16, 2000; 73 
FR 811, Jan. 4, 2008; 79 FR 10973, Feb. 27, 2014; 86 FR 13188, Mar. 8, 
2021]



PART 528_NEW ANIMAL DRUGS IN GENETICALLY ENGINEERED ANIMALS
--Table of Contents



Sec.
528.1070 Bc6 recombinant deoxyribonucleic acid construct.
528.1080 Bc2371 recombinant deoxyribonucleic acid construct.
528.1092 opAFP-GHc2 recombinant deoxyribonucleic acid construct.
528.2001 pPL657 recombinant deoxyribonucleic acid construct.
528.2010 Human lysosomal acid lipase recombinant deoxyribonucleic acid 
          construct.

    Authority: 21 U.S.C. 360b.

    Source: 74 FR 6823, Feb. 11, 2009, unless otherwise noted.



Sec. 528.1070  Bc6 recombinant deoxyribonucleic acid construct.

    (a) Specifications and indications for use. Five copies of a human 
Bc6 recombinant deoxyribonucleic acid (rDNA) construct located at the 
GTC 155-92 site in a specific hemizygous diploid line of dairy breeds of 
domestic goats (Capra aegagrus hircus) directing the expression of the 
human gene for antithrombin (which is intended for the treatment of 
humans) in the mammary gland of goats derived from lineage progenitor 
155-92.
    (b) Sponsor. See No. 086047 in Sec. 510.600 of this chapter.
    (c) Limitations. Food or feed from GTC-155-92 goats is not permitted 
in the food or feed supply.

[74 FR 6823, Feb. 11, 2009, as amended at 80 FR 34279, June 16, 2015]



Sec. 528.1080  Bc2371 recombinant deoxyribonucleic acid construct.

    (a) Specifications and intended use. A single copy of Bc2371, a 
human Factor VII recombinant deoxyribonucleic acid (rDNA) gene 
construct, located on chromosome 3p1.1-2 in a diploid line (R69) of 
hemizygous and homozygous New Zealand white rabbits (Oryctolagus 
cuniculus).
    (b) Sponsor. See No. 086047 in Sec. 510.600 of this chapter.
    (c) Conditions of use--(1) Intended use. The construct directs gene 
expression of recombinant human Factor VII (hFVII) in the mammary gland 
such that recombinant hFVII zymogen is

[[Page 385]]

present in the rabbit milk, enabling purification and activation of 
recombinant hFVIIa intended for the treatment of hemophilia A or B in 
humans with inhibitors to Factors VIII and IX.
    (2) Limitations. Food or feed from R69 rabbits is not permitted in 
the food or feed supply.

[84 FR 12494, Apr. 2, 2019]



Sec. 528.1092  opAFP-GHc2 recombinant deoxyribonucleic acid construct.

    (a) Specifications. A single copy of the [alpha]-form of the opAFP-
GHc2 recombinant deoxyribonucleic acid (rDNA) construct at the [alpha]-
locus in the EO-1 [alpha] lineage of triploid, hemizygous, all-female 
Atlantic salmon (Salmo salar).
    (b) Sponsor. See No. 086053 in Sec. 510.600 of this chapter.
    (c) Indications for use. Significantly more of these Atlantic salmon 
grow to at least 100 grams within 2,700 Celsius degree-days than their 
comparators.
    (d) Limitations. These Atlantic salmon are produced as eyed-eggs and 
grown-out only in physically-contained, freshwater culture facilities 
specified in an FDA-approved application.

[80 FR 73104, Nov. 24, 2015]



Sec. 528.2001  pPL657 recombinant deoxyribonucleic acid construct.

    (a) Specifications. pPL657 in the glycoprotein galactosyltransferase 
alpha-1,3 (GGTA1) gene in domestic pigs.
    (b) Sponsor. See No. 086134 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use--(1) Intended use. pPL657 rDNA construct in 
the glycoprotein galactosyltransferase alpha-1,3 gene (GGTA1) in the 
lineage of domestic pigs (Sus scrofa domesticus) hemizygous and 
homozygous for the intentional genomic alteration resulting in 
undetectable endogenous galactose alpha-1,3-galactose sugar residues on 
biological derivatives of domestic pigs homozygous for the intentional 
genomic alteration lineage that are intended to be used as sources of 
food or human therapeutics including excipients, devices, drugs, or 
biological products.
    (2) Limitations. Pigs of this lineage (possessing the intentional 
genomic alteration (pPL657 rDNA construct)) should not be treated with 
aminoglycoside drugs and must only be housed in physically contained 
facilities specified in the approved application.

[86 FR 17064, Apr. 1, 2021]



Sec. 528.2010  Human lysosomal acid lipase recombinant 
deoxyribonucleic acid construct.

    (a) Specifications. A single copy of a human lysosomal acid lipase 
(hLAL) recombinant deoxyribonucleic acid (rDNA) gene construct located 
at the SYN LAL-C site in chromosome 6 in a specific, diploid line (SBC 
LAL-C) of hemizygous and homozygous domestic chickens (Gallus gallus), 
derived from the lineage progenitor XLL 109.
    (b) Sponsor. See No. 069334 in Sec. 510.600 of this chapter.
    (c) Conditions of use--(1) Intended use. The gene construct directs 
the expression of that encoding gene such that recombinant, human 
lysosomal acid lipase (rhLAL) protein intended for the treatment of 
human disease is present in SBC LAL-C chicken egg whites.
    (2) Limitations. Food or feed from XLL 109 chickens is not permitted 
in the food or feed supply.

[81 FR 17608, Mar. 30, 2016]



PART 529_CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS--
Table of Contents



Sec.
529.40 Albuterol.
529.56 Amikacin.
529.382 Chloramine-T.
529.400 Chlorhexidine tablets and suspension.
529.443 Ciclesonide.
529.536 Detomidine.
529.539 Dexmedetomidine.
529.778 Doxycycline.
529.1030 Formalin.
529.1044 Gentamicin in certain other dosage forms.
529.1044a Gentamicin solution for infusion.
529.1044b Gentamicin solution for dipping eggs.
529.1115 Halothane.
529.1150 Hydrogen peroxide.
529.1186 Isoflurane.
529.1350 Meloxicam.
529.1660 Oxytetracycline.
529.1940 Progesterone intravaginal inserts.
529.2110 Sevoflurane.
529.2464 Ticarcillin.

[[Page 386]]

529.2503 Tricaine methanesulfonate.
529.2620 Triptorelin.

    Authority: 21 U.S.C. 360b.

    Source: 40 FR 13881, Mar. 27, 1975, unless otherwise noted.



Sec. 529.40  Albuterol.

    (a) Specifications. A net weight of 6.7 grams of formulated 
albuterol sulfate is supplied in a pressurized aluminum canister within 
an actuator system equipped with a detachable nasal delivery bulb.
    (b) Approvals. See No. 000010 in Sec. 510.600(c) of this chapter 
for uses as in paragraph (d) of this section.
    (c) Conditions of use--(1) Amount. Each valve actuation (puff) of 
the device delivers 120 micrograms (mcg) of albuterol sulfate. One dose 
is three (3) puffs, totaling 360 mcg.
    (2) Indications for use. For the immediate relief of bronchospasm 
and bronchoconstriction associated with reversible airway obstruction in 
horses.
    (3) Not for use in horses intended for food. Federal law restricts 
this drug to use by or on the order of a licensed veterinarian.

[67 FR 7072, Feb. 15, 2002, as amended at 79 FR 10973, Feb. 27 , 2014]



Sec. 529.56  Amikacin.

    (a) Specifications. Each milliliter (mL) of solution contains 250 
milligrams of amikacin as amikacin sulfate.
    (b) Sponsors. See Nos. 054771 and 058198 in Sec. 510.600(c) of this 
chapter.
    (c) Conditions of use in horses--(1) Amount. Administer 2 grams (8 
mL) diluted with 200 mL of sterile physiological saline by intrauterine 
infusion daily for 3 consecutive days.
    (2) Indications for use. For treating genital tract infections 
(endometritis, metritis, and pyometra) in mares caused by susceptible 
organisms including Escherichia coli, Pseudomonas spp., and Klebsiella 
spp.
    (3) Limitations. Do not use in horses intended for human 
consumption. Federal law restricts this drug to use by or on the order 
of a licensed veterinarian.

[76 FR 17339, Mar. 29, 2011, as amended at 78 FR 17597, Mar. 22, 2013; 
79 FR 10973, Feb. 27, 2014; 86 FR 14821, Mar. 19, 2021]



Sec. 529.382  Chloramine-T.

    (a) Specifications. Chloramine-T trihydrate powder for solution.
    (b) Sponsor. See No. 086009 in Sec. 510.600(c) of this chapter.
    (c) Related tolerances. See Sec. 556.118 of this chapter.
    (d) Conditions of use--(1) Freshwater-reared salmonids--(i) Amount. 
12 to 20 milligrams per liter (mg/L) water in a continuous flow water 
supply or as a static bath once per day for 60 minutes on consecutive or 
alternative days for three treatments.
    (ii) Indications for use. For the control of mortality in 
freshwater-reared salmonids due to bacterial gill disease associated 
with Flavobacterium spp.
    (2) Walleye--(i) Amount. 10 to 20 mg/L water in a continuous flow 
water supply or as a static bath once per day for 60 minutes on 
consecutive or alternative days for three treatments.
    (ii) Indications for use. For the control of mortality in walleye 
due to external columnaris disease associated with Flavobacterium 
columnare.
    (3) Freshwater-reared warmwater finfish--(i) Amount. 20 mg/L water 
in a continuous flow water supply or as a static bath once per day for 
60 minutes on consecutive or alternative days for three treatments.
    (ii) Indications for use. For the control of mortality in 
freshwater-reared warmwater finfish due to external columnaris disease 
associated with F. columnare.

[79 FR 37621, July 2, 2014]



Sec. 529.400  Chlorhexidine tablets and suspension.

    (a) Specification. Each tablet and each 28-milliliter syringe of 
suspension contain 1 gram of chlorhexidine dihydrochloride.
    (b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
    (c) Related tolerances. See Sec. 556.120 of this chapter.
    (d) Conditions of use--(1) Amount. Place 1 or 2 tablets deep in each 
uterine horn; or infuse a solution of 1 tablet disolved in an 
appropriate amount of clean boiled water; or infuse one syringe of 
suspension into the uterus.
    (2) Indications for use. For prevention or treatment of metritis and 
vaginitis

[[Page 387]]

in cows and mares when caused by pathogens sensitive to chlorhexidine 
dihydrochloride.
    (3) Limitations. Prior to administration, remove any unattached 
placental membranes, any excess uterine fluid or debris, and carefully 
clean external genitalia. Use a clean, sterile inseminating pipette for 
administrating solutions and suspensions. Treatment may be repeated in 
48 to 72 hours.

[43 FR 10705, Feb. 23, 1979, as amended at 79 FR 10973, Feb. 27, 2014; 
81 FR 67152, Sept. 30, 2016; 84 FR 32993, July 11, 2019]

    Editorial Note: At 79 FR 10973, Feb. 27, 2014, Sec. 529.400 was 
amended by revising the section heading, however, the section heading 
was not provided, therefore, the amendment could not be incorporated 
because of an inaccurate amendatory instruction.



Sec. 529.443  Ciclesonide.

    (a) Specifications. A non-pressurized metered dose inhaler and drug 
cartridge combination containing a solution of 30 milligrams/milliliter 
of the prodrug ciclesonide. Each actuation releases 343 micrograms (mcg) 
of ciclesonide.
    (b) Sponsor. See No. 000010 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use--(1) Amount. Administer an initial dose of 8 
actuations (2,744 mcg ciclesonide) twice daily for 5 days, followed by 
12 actuations (4,116 mcg ciclesonide) once daily for 5 days.
    (2) Indications for use. For the management of clinical signs 
associated with severe equine asthma.
    (3) Limitations. Do not use in horses intended for human 
consumption. Federal law restricts this drug to use by or on the order 
of a licensed veterinarian.

[86 FR 13188, Mar. 8, 2021]



Sec. 529.536  Detomidine.

    (a) Specifications. Each milliliter of gel contains 7.6 milligrams 
(mg) of detomidine hydrochloride.
    (b) Sponsor. See No. 052483 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in horses--(1) Amount. Administer 0.018 mg per 
pound (mg/lb) (0.040 mg/kilogram (kg) sublingually.
    (2) Indications for use. For sedation and restraint.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian. Do not use in horses intended for 
human consumption.

[75 FR 21163, Apr. 23, 2010, as amended at 76 FR 16533, Mar. 24, 2011]



Sec. 529.539  Dexmedetomidine.

    (a) Specifications. Each milliliter of gel contains 0.09 milligrams 
(mg) dexmedetomidine (equivalent to 0.1 mg dexmedetomidine 
hydrochloride).
    (b) Sponsor. See No. 052483 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use--(1) Amount. Administer onto the oral mucosa 
between the dog's cheek and gum at a dose of 125 micrograms per square 
meter.
    (2) Indications for use. For the treatment of noise aversion in 
dogs.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[81 FR 17608, Mar. 30, 2016]



Sec. 529.778  Doxycycline.

    (a) Specifications. Doxycycline hyclate solution contains 8.5 
percent doxycycline activity. A syringe of N-methyl-2-pyrrolidone and 
poly (DL-lactide) mixed with a syringe of doxycycline produces 0.5 
milliliter of solution.
    (b) Sponsor. See 054771 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in dogs--(1) Amount. Apply subgingivally to 
periodontal pocket(s) of affected teeth.
    (2) Indications for use. For treatment and control of periodontal 
disease.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[79 FR 10973, Feb. 27, 2014]



Sec. 529.1030  Formalin.

    (a) Specifications. Formalin is an aqueous solution containing 
approximately 37 percent by weight of formaldehyde gas, U.S.P.
    (b) Sponsors. See sponsors in Sec. 510.600(c) of this chapter for 
uses as in paragraph (d) of this section.
    (1) No. 050378 for use as in paragraph (d) of this section.
    (2) Nos. 049968 and 067188 for use as in paragraphs (d)(1)(i), (ii), 
and (iii), (d)(2)(i), (ii), and (iii), and (d)(3) of this section.

[[Page 388]]

    (c) [Reserved]
    (d) Conditions of use. It is added to environmental water as 
follows:
    (1) Indications for use--(i) Penaeid shrimp. For control of external 
protozoan parasites Bodo spp., Epistylis spp., and Zoothamnium spp.
    (ii) All finfish. For control of external protozoa Ichthyophthirius 
spp., Chilodonella spp., Ichthyobodo spp., Ambiphrya spp., Epistylis 
spp., and Trichodina spp., and the monogeneans Cleidodiscus spp., 
Gyrodactylus spp., and Dactylogyrus spp.
    (iii) All finfish eggs: For control of fungi of the family 
Saprolegniaceae.
    (iv) Freshwater-reared finfish. For the control of mortality due to 
saprolegniasis associated with fungi in the family Saprolegniaceae.
    (2) Amount. The drug concentrations required are as follows:
    (i) For control of external protozoan parasites on shrimp:

------------------------------------------------------------------------
                                  Concentration of formalin (microliters
                                                per liter)
                                 ---------------------------------------
             Shrimp               Tanks and raceways
                                    (up to 4 hours       Earthen ponds
                                        daily)        (single treatment)
------------------------------------------------------------------------
Penaeid Shrimp..................  50 to 100 \1\.....  25 \2\
------------------------------------------------------------------------
\1\ Treat for up to 4 hours daily. Treatment may be repeated daily until
  parasite control is achieved. Use the lower concentration when tanks
  or raceways are heavily loaded with phytoplankton or shrimp, to avoid
  oxygen depletion due to the biological oxygen demand created by decay
  of dead phytoplankton. Alternatively, a higher concentration might be
  used if dissolved oxygen is strictly monitored.
\2\ Single treatment. Treatment may be repeated in 5 to 10 days if
  needed.

    (ii) For control of external parasites on finfish:

------------------------------------------------------------------------
                         Administer in tanks and
                           raceways for up to 1    Administer in earthen
    Aquatic species       hour (microliter/liter  ponds single treatment
                           or part per million      ([micro]L/L or ppm)
                           ([micro]L/L or ppm))
------------------------------------------------------------------------
Salmon and trout:
Above 50 [deg]F          Up to 170                15 to 25 \1 2\
Below 50 [deg]F          Up to 250                15 to 25 \1 2\
All other finfish        Up to 250                15 to 25 \1 2\
------------------------------------------------------------------------
\1\ Use the lower concentration when ponds, tanks, or raceways are
  heavily loaded with phytoplankton or fish to avoid oxygen depletion
  due to the biological oxygen demand by decay of dead phytoplankton.
  Alternatively, a higher concentration may be used if dissolved oxygen
  is strictly monitored.
\2\ Although the indicated concentrations are considered safe for cold
  and warm water finfish, a small number of each lot or pond to be
  treated should always be used to check for any unusual sensitivity to
  formalin before proceeding.

    (iii) For control of fungi of the family Saprolegniaceae on finfish 
eggs: Eggs of all finfish except Acipenseriformes, 1,000 to 2,000 
[micro]L/L (ppm) for 15 minutes; eggs of Acipenseriformes, up to 1,500 
[micro]L/L (ppm) for 15 minutes. A preliminary bioassay should be 
conducted on a small subsample of fish eggs to determine sensitivity 
before treating an entire group. This is necessary for all species 
because egg sensitivity can vary with species or strain and the unique 
conditions at each facility.
    (iv) For the control of mortality in freshwater-reared finfish due 
to saprolegniasis associated with fungi in the family Saprolegniaceae: 
In tanks and raceways, administer 150 [micro]L/L (ppm) for 60 minutes 
per day on alternate days for three treatments.
    (3) Limitations. Fish tanks and raceways may be treated daily until 
parasite control is achieved. Pond treatment may be repeated in 5 to 10 
days if needed. However, pond treatments for Ichthyophthirius spp. 
should be made at 2-day intervals until control is achieved. Egg tanks 
may be treated as often as necessary to prevent growth of fungi. Do not 
use formalin which has been subjected to temperatures below 40 [deg]F, 
or allowed to freeze. Treatments in tanks and raceways should never 
exceed 1 hour for fish or 4 hours for penaeid shrimp (even if they show 
no sign of distress), nor should it exceed 15 minutes for fish eggs. Do 
not apply formalin to ponds with water warmer than 27 [deg]C (80 
[deg]F), when a heavy bloom of phytoplankton is present, or when the 
concentration of dissolved oxygen is less than 5 milligrams per liter.

[51 FR 11441, Apr. 3, 1986, as amended at 58 FR 59169, Nov. 8, 1993; 59 
FR 60076, Nov. 22, 1994; 63 FR 38304, July 16, 1998; 68 FR 5563; Feb. 4, 
2003; 72 FR 45158, Aug. 13, 2007; 76 FR 17339, Mar. 29, 2011; 79 FR 
2786, Jan. 16, 2014; 82 FR 58556, Dec. 13, 2017; 84 FR 53311, Oct. 7, 
2019]



Sec. 529.1044  Gentamicin in certain other dosage forms.



Sec. 529.1044a  Gentamicin solution for infusion.

    (a) Specifications. Each milliliter of solution contains 50 or 100 
milligrams gentamicin sulfate.
    (b) Sponsors. See Nos. 000061, 016592, 054628, 054771, 058005, 
058198, and 061133 in Sec. 510.600(c) of this chapter.

[[Page 389]]

    (c) Conditions of use in horses--(1) Amount. Infuse 2 to 2.5 grams 
per day for 3 to 5 days during estrus.
    (2) Indications for use. For control of bacterial infections of the 
uterus (metritis) and as an aid in improving conception in mares with 
uterine infections caused by bacteria sensitive to gentamicin.
    (3) Limitations. Do not use in horses intended for human 
consumption. Federal law restricts this drug to use by or on the order 
of a licensed veterinarian.

[71 FR 51727, Aug. 31, 2006, as amended at 78 FR 17597, Mar. 22, 2013; 
78 FR 21060, Apr. 9, 2013; 79 FR 10973, Feb. 27, 2014; 83 FR 48947, 
Sept. 28, 2018; 84 FR 8974, Mar. 13, 2019; 86 FR 14821, Mar. 19, 2021]



Sec. 529.1044b  Gentamicin solution for dipping eggs.

    (a) Specifications. Each milliliter of solution contains gentamicin 
sulfate equivalent to 50 milligrams of gentamicin base.
    (b) Sponsors. See Nos. 000061 and 054925 in Sec. 510.600(c) of this 
chapter.
    (c) Conditions of use in turkeys--(1) Amount. The drug is added to 
clean water to provide a dip solution with a gentamicin concentration of 
250 to 1,000 parts per million. A concentration of 500 parts per million 
is recommended. Clean eggs should be held submerged in the gentamicin 
solution under a vacuum of about 27.5 to 38 centimeters of mercury for 5 
minutes followed by additional soaking in gentamicin solution for 
approximately 10 minutes at atmospheric pressure. Eggs can also be 
treated by warming them for 3 to 6 hours at approximately 100 [deg]F 
then immediately submerging them in gentamicin solution maintained at 
about 40 [deg]F, keeping the eggs submerged for 10 to 15 minutes.
    (2) Indications for use. As an aid in the reduction or elimination 
of the following microorganisms from turkey-hatching eggs: Arizona 
hinshawii (paracolon), Salmonella Saintpaul, and Mycoplasma meleagridis.
    (3) Limitations. For use in the dipping treatment of turkey-hatching 
eggs only. Eggs which have been dipped in the drug shall not be used for 
food.

[40 FR 13881, Mar. 27, 1975, as amended at 52 FR 7833, Mar. 13, 1987; 62 
FR 22889, Apr. 28, 1997; 71 FR 13543, Mar. 16, 2006; 79 FR 10973, Feb. 
27, 2014]



Sec. 529.1115  Halothane.

    (a) Specifications. The drug is a colorless, odorless, nonflammable, 
nonexplosive, heavy liquid containing 0.01 percent thymol as a 
preservative.
    (b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use--(1) Amount. Two to 5 percent of inhaled 
atmosphere for induction of anesthesia; 0.5 to 2 percent for maintenance 
of anesthesia.
    (2) Indications for use. For nonfood animals for the induction and 
maintenance of anesthesia.
    (3) Limitations. Not for use in animals intended for food. Federal 
law restricts this drug to use by or on the order of a licensed 
veterinarian.

[46 FR 27915, May 22, 1981, as amended at 62 FR 29014, May 29, 1997; 79 
FR 10973, Feb. 27, 2014; 85 FR 4208, Jan. 24, 2020]



Sec. 529.1150  Hydrogen peroxide.

    (a) Specifications. Each milliliter of solution contains 396.1 
milligrams (mg) hydrogen peroxide (a 35% w/w solution).
    (b) Sponsor. See No. 050378 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use--(1) Indications and amount. (i) Freshwater-
reared finfish eggs for the control of mortality in due to 
saprolegniasis associated with fungi in the family Saprolegniaceae:
    (A) For all coldwater and coolwater species of freshwater-reared 
finfish eggs: 500 to 1,000 mg per liter (/L) of culture water for 15 
minutes in a continuous flow system once per day on consecutive or 
alternate days until hatch, or
    (B) For all freshwater-reared warmwater finfish eggs: 750 to 1,000 
mg/L for 15 minutes in a continuous flow system once per day on 
consecutive or alternate days until hatch.
    (ii) Freshwater-reared finfish for the control of mortality due to 
saprolegniasis associated with the fungi in the family Saprolegniaceae: 
For freshwater-reared coldwater finfish

[[Page 390]]

including salmonids (all life stages), freshwater-reared coolwater 
finfish fingerlings and adults, and freshwater-reared warmwater finfish 
fingerlings and adults: 75 mg/L for 60 minutes in continuous flow water 
supply or as a static bath once per day on alternate days for three 
treatments.
    (iii) Freshwater-reared salmonids for the control of mortality due 
to bacterial gill disease associated with Flavobacterium branchiophilum: 
100 mg/L for 30 minutes, or 50 to 100 mg/L for 60 minutes, in a 
continuous flow water supply or as a static bath once per day on 
alternate days for three treatments.
    (iv) Freshwater-reared salmonids for the treatment and control of 
Gyrodactylus spp: 100 mg/L for 30 minutes, or 50 to 100 mg/L for 60 
minutes, in a continuous flow water supply or as a static bath once per 
day on alternate days for three treatments.
    (v) Freshwater-reared coolwater and warmwater finfish fingerlings 
and adults for the control of mortality due to external columnaris 
disease associated with Flavobacterium columnare: 50 to 75 mg/L for 60 
minutes in continuous flow water supply or as a static bath once per day 
on alternate days for three treatments.
    (vi) Freshwater-reared coolwater finfish fry and warmwater finfish 
fry for the control of mortality due to external columnaris disease 
associated with Flavobacterium columnare: 50 mg/L for 60 minutes in 
continuous flow water supply or as a static bath once per day on 
alternate days for three treatments.
    (2) Limitations. (i) Initial bioassay on a small number is 
recommended before treating the entire group.
    (ii) Eggs: Some strains of rainbow trout eggs are sensitive to 
hydrogen peroxide treatment at a time during incubation concurrent with 
blastopore formation through closure, about 70 to 140 Daily Temperature 
Units, [deg]C. Consider withholding treatment or using an alternate 
therapeutant during that sensitive time to reduce egg mortalities due to 
drug toxicity.
    (iii) Finfish: Because finfish sensitivity to 35% PEROX-AID[supreg] 
increases with increasing water temperature, consider administering 
initial treatments at the lower end of the treatment regimen or reducing 
water temperature before treatment. Do not use this product to treat 
northern pike (Esox lucius) or paddlefish (Polyodon spathula) of any 
age. Do not use this product to treat pallid sturgeon fry. Use with 
caution on walleye (Sander vitreus) and ornamental finfish.
    (iv) Preharvest withdrawal time: Zero days.

[72 FR 5330, Feb. 6, 2007, as amended at 78 FR 73698, Dec. 9, 2013; 85 
FR 4208, Jan. 24, 2020]



Sec. 529.1186  Isoflurane.

    (a) Specifications. The drug is a clear, colorless, stable liquid.
    (b) Sponsors. See Nos. 012164, 054771, 065085, and 066794 in Sec. 
510.600(c) of this chapter.
    (c) Conditions of use. Administer by inhalation:
    (1) Amount--(i) Horses: For induction of surgical anesthesia: 3 to 5 
percent isoflurane (with oxygen) for 5 to 10 minutes. For maintenance of 
surgical anesthesia: 1.5 to 1.8 percent isoflurane (with oxygen).
    (ii) Dogs: For induction of surgical anesthesia: 2 to 2.5 percent 
isoflurane (with oxygen) for 5 to 10 minutes. For maintenance of 
surgical anesthesia: 1.5 to 1.8 percent isoflurane (with oxygen).
    (2) Indications for use. For induction and maintenance of general 
anesthesia in horses and dogs.
    (3) Limitations. Do not use in horses intended for human 
consumption. Federal law restricts this drug to use by or on the order 
of a licensed veterinarian.

[51 FR 594, Jan. 7, 1986, as amended at 54 FR 23472, June 1, 1989; 58 FR 
17346, Apr. 2, 1993; 59 FR 44315, Aug. 29, 1994; 60 FR 40456, Aug. 9, 
1995; 63 FR 8122, Feb. 18, 1998; 63 FR 24106, May 1, 1998; 66 FR 17510, 
Apr. 2, 2001; 71 FR 43967, Aug. 3, 2006; 74 FR 68530, Dec. 28, 2009; 76 
FR 16533, Mar. 24, 2011; 78 FR 14669, Mar. 7, 2013; 78 FR 17868, Mar. 
25, 2013; 80 FR 18776, Apr. 8, 2015; 82 FR 12170, Mar. 1, 2017]



Sec. 529.1350  Meloxicam.

    (a) Specifications. Each milliliter of solution contains 5 
milligrams (mg) meloxicam.
    (b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in dogs--(1) Amount. Administer 0.1 mg per 
kilogram of body weight once daily using the metered dose pump.

[[Page 391]]

    (2) Indications for use. For the control of pain and inflammation 
associated with osteoarthritis in dogs.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[77 FR 76863, Dec. 31, 2012, as amended at 80 FR 18776, Apr. 8, 2015]



Sec. 529.1660  Oxytetracycline.

    (a) Specifications. (1) Each gram of powder contains 366 milligrams 
(mg) oxytetracycline hydrochloride.
    (2) Each gram of powder contains 753 mg oxytetracycline 
hydrochloride.
    (b) Sponsors. See sponsors in Sec. 510.600(c) of this chapter for 
use of products described in paragraph (a) of this section as in 
paragraph (d) of this section.
    (1) Nos. 054771 and 061133 for use of product in paragraph (a)(1) of 
this section.
    (2) Nos. 054771, 061133, and 069254 for use of product described in 
paragraph (a)(2) of this section.
    (c) Related tolerances. See Sec. 556.500 of this chapter.
    (d) Conditions of use in finfish--(1) Amount. Immerse fish in a 
solution containing 200 to 700 mg oxytetracycline hydrochloride 
(buffered) per liter of water for 2 to 6 hours.
    (2) Indications for use. For skeletal marking of finfish fry and 
fingerlings.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[69 FR 6557, Feb. 11, 2004, as amended at 69 FR 61999, Oct. 22, 2004; 70 
FR 41140, July 18, 2005; 72 FR 26289, May 9, 2007; 76 FR 17026, Mar. 28, 
2011; 79 FR 10973, Feb. 27, 2014; 81 FR 22524, Apr. 18, 2016; 81 FR 
94991, Dec. 27, 2016; 84 FR 8974, Mar. 13, 2019]



Sec. 529.1940  Progesterone intravaginal inserts.

    (a) Specifications. Each insert contains:
    (1) 1.38 grams (g) progesterone in molded silicone over a nylon 
spine.
    (2) 0.3 g progesterone in molded silicone over a flexible nylon 
spine.
    (b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter for 
use of the product described in paragraph (a)(1) of this section as in 
paragraph (e)(1) of this section; and the product described in paragraph 
(a)(2) of this section as in paragraph (e)(2) of this section.
    (c) Related tolerances. See Sec. 556.540 of this chapter.
    (d) Special considerations. Product labeling shall bear the 
following warning: ``Avoid contact with skin by wearing protective 
gloves when handling inserts. Store removed inserts in a sealable 
container until they can be disposed of in accordance with applicable 
local, state, and Federal regulations.''
    (e) Conditions of use--(1) Cows--(i) Amount. Administer one 
intravaginal insert per animal for 7 days. When used for indications 
listed in paragraph (e)(1)(ii)(A) of this section, administer 25 mg 
dinoprost as a single intramuscular injection 1 day prior to insert 
removal (Day 6). When used for indications listed in paragraph 
(e)(1)(ii)(B) of this section, administer 25 mg dinoprost as a single 
intramuscular injection on the day of insert removal (Day 7).
    (ii) Indications for use. (A) For synchronization of estrus in 
suckled beef cows and replacement beef and dairy heifers; for 
advancement of first postpartum estrus in suckled beef cows; and for 
advancement of first pubertal estrus in replacement beef heifers.
    (B) For synchronization of estrus in lactating dairy cows.
    (C) For synchronization of the return to estrus in lactating dairy 
cows inseminated at the immediately preceding estrus.
    (D) For induction of estrous cycles in anestrous lactating dairy 
cows.
    (iii) Limitations. Do not use in beef or dairy heifers of 
insufficient size or age for breeding or in animals with abnormal, 
immature, or infected genital tracts. Do not use in beef cows that are 
fewer than 20 days postpartum. Do not use an insert more than once. To 
prevent the potential transmission of venereal and bloodborne diseases, 
the inserts should be disposed after a single use. Administration of 
vaginal inserts for periods greater than 7 days may result in reduced 
fertility. Dinoprost injection for use in paragraphs (e)(1)(ii)(A) and 
(e)(1)(ii)(B) of this section as in Sec. 522.690 of this chapter, 
provided by No. 054771 in Sec. 510.600(c) of this chapter.

[[Page 392]]

    (2) Ewes--(i) Amount. Administer one intravaginal insert per animal 
for 5 days.
    (ii) Indications for use. For induction of estrus in ewes (sheep) 
during seasonal anestrus.
    (iii) Limitations. Do not use in animals with abnormal, immature, or 
infected genital tracts; or in ewes that have never lambed. Do not use 
an insert more than once. To prevent the potential transmission of 
venereal and bloodborne diseases, the inserts should be disposed after a 
single use.

[74 FR 59074, Nov. 17, 2009, as amended at 75 FR 63085, Oct. 14, 2010; 
79 FR 10965, 10974, Feb. 27, 2014; 79 FR 44278, July 31, 2014]



Sec. 529.2110  Sevoflurane.

    (a) Specifications. Sevoflurane liquid.
    (b) Sponsors. See Nos. 012164, 054771, and 066794 in Sec. 
510.600(c) of this chapter.
    (c) Conditions of use--(1) Amount. For induction of surgical 
anesthesia: up to 7 percent sevoflurane. For maintenance of surgical 
anesthesia: 3.7 to 4 percent sevoflurane with oxygen in the absence of 
premedication and 3.3 to 3.6 percent in the presence of premedication.
    (2) Indications for use. For induction and maintenance of general 
anesthesia in dogs.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[64 FR 71640, Dec. 22, 1999, as amended at 73 FR 25508, May 7, 2008; 74 
FR 10484, Mar. 11, 2009, 75 FR 1021, Jan. 8, 2010; 76 FR 16533, Mar. 24, 
2011; 78 FR 17868, Mar. 25, 2013; 80 FR 18776, Apr. 8, 2015. 
Redesignated at 86 FR 13188, Mar. 8, 2021]



Sec. 529.2464  Ticarcillin.

    (a) Specifications. Each vial contains ticarcillin disodium powder 
equivalent to 6 grams of ticarcillin for reconstitution with 25 
milliliters of sterile water for injection or sterile physiological 
saline.
    (b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in horses--(1) Amount. Administer 6 grams 
daily by intrauterine infusion for 3 consecutive days during estrus.
    (2) Indications for use. For the treatment of endometritis caused by 
beta-hemolytic streptococci.
    (3) Limitations. Do not use in horses intended for human 
consumption. Federal law restricts this drug to use by or on the order 
of a licensed veterinarian.

[79 FR 10974, Feb. 27, 2014]



Sec. 529.2503  Tricaine methanesulfonate.

    (a) Specifications. The drug is ethyl-m-amino-benzoate 
methanesulfonate.
    (b) Sponsor. See Nos. 050378 and 051212 in Sec. 510.600(c) of this 
chapter.
    (c) Conditions of use--(1) Amount. It is used as follows:
    (i) Fish. The drug is added to ambient water at a concentration of 
from 15 to 330 milligrams per liter depending upon the degree of 
anesthetization or sedation desired, the species and size of the fish, 
and the temperature and softness of the water. Preliminary tests of 
solutions must be made with small numbers of fish to determine the 
desired rates of sedation or anesthesia and the appropriate exposure 
times for the specific lots of fish under prevailing conditions.
    (ii) Amphibians and other aquatic coldblooded animals. The drug is 
added to ambient water in concentrations of from 1:1000 to 1:20,000 
depending upon species and stage of development.
    (2) Indications for use. For the temporary immobilization of fish, 
amphibians, and other aquatic coldblooded animals (poikilotherms) as an 
aid in handling during manual spawning (fish stripping), weighing, 
measuring, marking, surgical operations, transport, photography, and 
research.
    (3) Limitations. Do not use within 21 days of harvesting fish for 
food. Use in fish intended for food should be restricted to Ictaluridae, 
Salmonidae, Esocidae, and Percidae, and water temperature exceeding 10 
[deg]C (50 [deg]F). In other fish and in coldblooded animals, the drug 
should be limited to hatchery or laboratory use.

[79 FR 10974, Feb. 27, 2014]



Sec. 529.2620  Triptorelin.

    (a) Specifications. Each milliliter of gel contains 100 micrograms 
(mcg) triptorelin as triptorelin acetate.
    (b) Sponsor. See No. 051233 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in swine--(1) Amount. Administer 200 mcg

[[Page 393]]

intravaginally approximately 96 hours after weaning.
    (2) Indications for use. For the synchronization of time of 
insemination in weaned sows to facilitate a single fixed-time artificial 
insemination.
    (3) Limitations. Not approved for use in gilts. Safety and 
effectiveness have not been evaluated in these animals. Should not be 
used in sows with obvious reproductive tract abnormalities.

[77 FR 64717, Oct. 23, 2012]



PART 530_EXTRALABEL DRUG USE IN ANIMALS--Table of Contents



                      Subpart A_General Provisions

Sec.
530.1 Scope.
530.2 Purpose.
530.3 Definitions.
530.4 Advertising and promotion.
530.5 Veterinary records.

 Subpart B_Rules and Provisions for Extralabel Uses of Drugs in Animals

530.10 Provision permitting extralabel use of animal drugs.
530.11 Limitations.
530.12 Labeling.
530.13 Extralabel use from compounding of approved new animal and 
          approved human drugs.

 Subpart C_Specific Provisions Relating to Extralabel Use of Animal and 
                  Human Drugs in Food-Producing Animals

530.20 Conditions for permitted extralabel animal and human drug use in 
          food-producing animals.
530.21 Prohibitions for food-producing animals.
530.22 Safe levels and analytical methods for food-producing animals.
530.23 Procedure for setting and announcing safe levels.
530.24 Procedure for announcing analytical methods for drug residue 
          quantification.
530.25 Orders prohibiting extralabel uses for drugs in food-producing 
          animals.

   Subpart D_Extralabel Use of Human and Animal Drugs in Animals Not 
                     Intended for Human Consumption

530.30 Extralabel drug use in nonfood animals.

 Subpart E_Safe Levels for Extralabel Use of Drugs in Animals and Drugs 
                Prohibited From Extralabel Use in Animals

530.40 Safe levels and availability of analytical methods.
530.41 Drugs prohibited for extralabel use in animals.

    Authority: 15 U.S.C. 1453, 1454, 1455; 21 U.S.C. 321, 331, 351, 352, 
353, 355, 357, 360b, 371, 379e.

    Source: 61 FR 57743, Nov. 7, 1996, unless otherwise noted.



                      Subpart A_General Provisions



Sec. 530.1  Scope.

    This part applies to the extralabel use in an animal of any approved 
new animal drug or approved new human drug by or on the lawful order of 
a licensed veterinarian within the context of a valid veterinary-client-
patient relationship.



Sec. 530.2  Purpose.

    The purpose of this part is to establish conditions for extralabel 
use or intended extralabel use in animals by or on the lawful order of 
licensed veterinarians of Food and Drug Administration approved new 
animal drugs and approved new human drugs. Such use is limited to 
treatment modalities when the health of an animal is threatened or 
suffering or death may result from failure to treat. This section 
implements the Animal Medicinal Drug Use Clarification Act of 1994 (the 
AMDUCA) (Pub. L. 103-396).



Sec. 530.3  Definitions.

    (a) Extralabel use means actual use or intended use of a drug in an 
animal in a manner that is not in accordance with the approved labeling. 
This includes, but is not limited to, use in species not listed in the 
labeling, use for indications (disease or other conditions) not listed 
in the labeling, use at

[[Page 394]]

dosage levels, frequencies, or routes of administration other than those 
stated in the labeling, and deviation from the labeled withdrawal time 
based on these different uses.
    (b) FDA means the U.S. Food and Drug Administration.
    (c) The phrase a reasonable probability that a drug's use may 
present a risk to the public health means that FDA has reason to believe 
that use of a drug may be likely to cause a potential adverse event.
    (d) The phrase use of a drug may present a risk to the public health 
means that FDA has information that indicates that use of a drug may 
cause an adverse event.
    (e) The phrase use of a drug presents a risk to the public health 
means that FDA has evidence that demonstrates that the use of a drug has 
caused or likely will cause an adverse event.
    (f) A residue means any compound present in edible tissues that 
results from the use of a drug, and includes the drug, its metabolites, 
and any other substance formed in or on food because of the drug's use.
    (g) A safe level is a conservative estimate of a drug residue level 
in edible animal tissue derived from food safety data or other 
scientific information. Concentrations of residues in tissue below the 
safe level will not raise human food safety concerns. A safe level is 
not a safe concentration or a tolerance and does not indicate that an 
approval exists for the drug in that species or category of animal from 
which the food is derived.
    (h) Veterinarian means a person licensed by a State or Territory to 
practice veterinary medicine.
    (i) A valid veterinarian-client-patient relationship is one in 
which:
    (1) A veterinarian has assumed the responsibility for making medical 
judgments regarding the health of (an) animal(s) and the need for 
medical treatment, and the client (the owner of the animal or animals or 
other caretaker) has agreed to follow the instructions of the 
veterinarian;
    (2) There is sufficient knowledge of the animal(s) by the 
veterinarian to initiate at least a general or preliminary diagnosis of 
the medical condition of the animal(s); and
    (3) The practicing veterinarian is readily available for followup in 
case of adverse reactions or failure of the regimen of therapy. Such a 
relationship can exist only when the veterinarian has recently seen and 
is personally acquainted with the keeping and care of the animal(s) by 
virtue of examination of the animal(s), and/or by medically appropriate 
and timely visits to the premises where the animal(s) are kept.



Sec. 530.4  Advertising and promotion.

    Nothing in this part shall be construed as permitting the 
advertising or promotion of extralabel uses in animals of approved new 
animal drugs or approved human drugs.



Sec. 530.5  Veterinary records.

    (a) As a condition of extralabel use permitted under this part, to 
permit FDA to ascertain any extralabel use or intended extralabel use of 
drugs that the agency has determined may present a risk to the public 
health, veterinarians shall maintain the following records of extralabel 
uses. Such records shall be legible, documented in an accurate and 
timely manner, and be readily accessible to permit prompt retrieval of 
information. Such records shall be adequate to substantiate the 
identification of the animals and shall be maintained either as 
individual records or, in food animal practices, on a group, herd, 
flock, or per-client basis. Records shall be adequate to provide the 
following information:
    (1) The established name of the drug and its active ingredient, or 
if formulated from more than one ingredient, the established name of 
each ingredient;
    (2) The condition treated;
    (3) The species of the treated animal(s);
    (4) The dosage administered;
    (5) The duration of treatment;
    (6) The numbers of animals treated; and
    (7) The specified withdrawal, withholding, or discard time(s), if 
applicable, for meat, milk, eggs, or any food which might be derived 
from any food animals treated.

[[Page 395]]

    (b) A veterinarian shall keep all required records for 2 years or as 
otherwise required by Federal or State law, whichever is greater.
    (c) Any person who is in charge, control, or custody of such records 
shall, upon request of a person designated by FDA, permit such person 
designated by FDA to, at all reasonable times, have access to, permit 
copying, and verify such records.



 Subpart B_Rules and Provisions for Extralabel Uses of Drugs in Animals



Sec. 530.10  Provision permitting extralabel use of animal drugs.

    An approved new animal drug or human drug intended to be used for an 
extralabel purpose in an animal is not unsafe under section 512 of the 
act and is exempt from the labeling requirements of section 502(f) of 
the act if such use is:
    (a) By or on the lawful written or oral order of a licensed 
veterinarian within the context of a valid veterinarian-client-patient 
relationship; and
    (b) In compliance with this part.



Sec. 530.11  Limitations.

    In addition to uses which do not comply with the provision set forth 
in Sec. 530.10, the following specific extralabel uses are not 
permitted and result in the drug being deemed unsafe within the meaning 
of section 512 of the act:
    (a) Extralabel use in an animal of an approved new animal drug or 
human drug by a lay person (except when under the supervision of a 
licensed veterinarian);
    (b) Extralabel use of an approved new animal drug or human drug in 
or on an animal feed;
    (c) Extralabel use resulting in any residue which may present a risk 
to the public health; and
    (d) Extralabel use resulting in any residue above an established 
safe level, safe concentration or tolerance.



Sec. 530.12  Labeling.

    Any human or animal drug prescribed and dispensed for extralabel use 
by a veterinarian or dispensed by a pharmacist on the order of a 
veterinarian shall bear or be accompanied by labeling information 
adequate to assure the safe and proper use of the product. Such 
information shall include the following:
    (a) The name and address of the prescribing veterinarian. If the 
drug is dispensed by a pharmacy on the order of a veterinarian, the 
labeling shall include the name of the prescribing veterinarian and the 
name and address of the dispensing pharmacy, and may include the address 
of the prescribing veterinarian;
    (b) The established name of the drug or, if formulated from more 
than one active ingredient, the established name of each ingredient;
    (c) Any directions for use specified by the veterinarian, including 
the class/species or identification of the animal or herd, flock, pen, 
lot, or other group of animals being treated, in which the drug is 
intended to be used; the dosage, frequency, and route of administration; 
and the duration of therapy;
    (d) Any cautionary statements; and
    (e) The veterinarian's specified withdrawal, withholding, or discard 
time for meat, milk, eggs, or any other food which might be derived from 
the treated animal or animals.



Sec. 530.13  Extralabel use from compounding of approved new animal
and approved human drugs.

    (a) This part applies to compounding of a product from approved 
animal or human drugs by a veterinarian or a pharmacist on the order of 
a veterinarian within the practice of veterinary medicine. Nothing in 
this part shall be construed as permitting compounding from bulk drugs.
    (b) Extralabel use from compounding of approved new animal or human 
drugs is permitted if:
    (1) All relevant portions of this part have been complied with;
    (2) There is no approved new animal or approved new human drug that, 
when used as labeled or in conformity with criteria established in this 
part, will, in the available dosage form and concentration, 
appropriately treat the condition diagnosed. Compounding from a human 
drug for use in food-producing animals will not be permitted if

[[Page 396]]

an approved animal drug can be used for the compounding;
    (3) The compounding is performed by a licensed pharmacist or 
veterinarian within the scope of a professional practice;
    (4) Adequate procedures and processes are followed that ensure the 
safety and effectiveness of the compounded product;
    (5) The scale of the compounding operation is commensurate with the 
established need for compounded products (e.g., similar to that of 
comparable practices); and
    (6) All relevant State laws relating to the compounding of drugs for 
use in animals are followed.
    (c) Guidance on the subject of compounding may be found in guidance 
documents issued by FDA.



 Subpart C_Specific Provisions Relating to Extralabel Use of Animal and 
                  Human Drugs in Food-Producing Animals



Sec. 530.20  Conditions for permitted extralabel animal and human drug
use in food-producing animals.

    (a) The following conditions must be met for a permitted extralabel 
use in food-producing animals of approved new animal and human drugs:
    (1) There is no approved new animal drug that is labeled for such 
use and that contains the same active ingredient which is in the 
required dosage form and concentration, except where a veterinarian 
finds, within the context of a valid veterinarian-client-patient 
relationship, that the approved new animal drug is clinically 
ineffective for its intended use.
    (2) Prior to prescribing or dispensing an approved new animal or 
human drug for an extralabel use in food animals, the veterinarian must:
    (i) Make a careful diagnosis and evaluation of the conditions for 
which the drug is to be used;
    (ii) Establish a substantially extended withdrawal period prior to 
marketing of milk, meat, eggs, or other edible products supported by 
appropriate scientific information, if applicable;
    (iii) Institute procedures to assure that the identity of the 
treated animal or animals is carefully maintained; and
    (iv) Take appropriate measures to assure that assigned timeframes 
for withdrawal are met and no illegal drug residues occur in any food-
producing animal subjected to extralabel treatment.
    (b) The following additional conditions must be met for a permitted 
extralabel use of in food-producing animals an approved human drug, or 
of an animal drug approved only for use in animals not intended for 
human consumption:
    (1) Such use must be accomplished in accordance with an appropriate 
medical rationale; and
    (2) If scientific information on the human food safety aspect of the 
use of the drug in food-producing animals is not available, the 
veterinarian must take appropriate measures to assure that the animal 
and its food products will not enter the human food supply.
    (c) Extralabel use of an approved human drug in a food-producing 
animal is not permitted under this part if an animal drug approved for 
use in food-producing animals can be used in an extralabel manner for 
the particular use.



Sec. 530.21  Prohibitions for food-producing animals.

    (a) FDA may prohibit the extralabel use of an approved new animal or 
human drug or class of drugs in food-producing animals if FDA determines 
that:
    (1) An acceptable analytical method needs to be established and such 
method has not been established or cannot be established; or
    (2) The extralabel use of the drug or class of drugs presents a risk 
to the public health.
    (b) A prohibition may be a general ban on the extralabel use of the 
drug or class of drugs or may be limited to a specific species, 
indication, dosage form, route of administration, or combination of 
factors.



Sec. 530.22  Safe levels and analytical methods for food-producing
animals.

    (a) FDA may establish a safe level for extralabel use of an approved 
human drug or an approved new animal drug when the agency finds that 
there is a reasonable probability that an

[[Page 397]]

extralabel use may present a risk to the public health. FDA may:
    (1) Establish a finite safe level based on residue and metabolism 
information from available sources;
    (2) Establish a safe level based on the lowest level that can be 
measured by a practical analytical method; or
    (3) Establish a safe level based on other appropriate scientific, 
technical, or regulatory criteria.
    (b) FDA may require the development of an acceptable analytical 
method for the quantification of residues above any safe level 
established under this part. If FDA requires the development of such an 
acceptable analytical method, the agency will publish notice of that 
requirement in the Federal Register.
    (c) The extralabel use of an animal drug or human drug that results 
in residues exceeding a safe level established under this part is an 
unsafe use of such drug.
    (d) If the agency establishes a safe level for a particular species 
or category of animals and a tolerance or safe concentration is later 
established through an approval for that particular species or category 
of animals, for that species or category of animals, the safe level is 
superseded by the tolerance or safe concentration for that species or 
category of animals.



Sec. 530.23  Procedure for setting and announcing safe levels.

    (a) FDA may issue an order establishing a safe level for a residue 
of an extralabel use of an approved human drug or an approved animal 
drug. The agency will publish in the Federal Register a notice of the 
order. The notice will include:
    (1) A statement setting forth the agency's finding that there is a 
reasonable probability that extralabel use in animals of the human drug 
or animal drug may present a risk to the public health;
    (2) A statement of the basis for that finding; and
    (3) A request for public comments.
    (b) A current listing of those drugs for which a safe level for 
extralabel drug use in food-producing animals has been established, the 
specific safe levels, and the availability, if any, of a specific 
analytical method or methods for drug residue detection will be codified 
in Sec. 530.40.



Sec. 530.24  Procedure for announcing analytical methods for drug 
residue quantification.

    (a) FDA may issue an order announcing a specific analytical method 
or methods for the quantification of extralabel use drug residues above 
the safe levels established under Sec. 530.22 for extralabel use of an 
approved human drug or an approved animal drug. The agency will publish 
in the Federal Register a notice of the order, including the name of the 
specific analytical method or methods and the drug or drugs for which 
the method is applicable.
    (b) Copies of analytical methods for the quantification of 
extralabel use drug residues above the safe levels established under 
Sec. 530.22 will be available upon request from the Communications and 
Education Branch (HFV-12), Division of Program Communication and 
Administrative Management, Center for Veterinary Medicine, 7500 Standish 
Pl., Rockville, MD 20855. When an analytical method for the detection of 
extralabel use drug residues above the safe levels established under 
Sec. 530.22 is developed, and that method is acceptable to the agency, 
FDA will incorporate that method by reference.



Sec. 530.25  Orders prohibiting extralabel uses for drugs in 
food-producing animals.

    (a) FDA may issue an order prohibiting extralabel use of an approved 
new animal or human drug in food-producing animals if the agency finds, 
after providing an opportunity for public comment, that:
    (1) An acceptable analytical method required under Sec. 530.22 has 
not been developed, submitted, and found to be acceptable by FDA or that 
such method cannot be established; or
    (2) The extralabel use in animals presents a risk to the public 
health.
    (b) After making a determination that the analytical method required 
under Sec. 530.22 has not been developed and submitted, or that such 
method cannot be established, or that an

[[Page 398]]

extralabel use in animals of a particular human drug or animal drug 
presents a risk to the public health, FDA will publish in the Federal 
Register, with a 90-day delayed effective date, an order of prohibition 
for an extralabel use of a drug in food-producing animals. Such order 
shall state that an acceptable analytical method required under Sec. 
530.22 has not been developed, submitted, and found to be acceptable by 
FDA; that such method cannot be established; or that the extralabel use 
in animals presents a risk to the public health; and shall:
    (1) Specify the nature and extent of the order of prohibition and 
the reasons for the prohibition;
    (2) Request public comments; and
    (3) Provide a period of not less than 60 days for comments.
    (c) The order of prohibition will become effective 90 days after 
date of publication of the order unless FDA publishes a notice in the 
Federal Register prior to that date, that revokes the order of 
prohibition, modifies it, or extends the period of public comment.
    (d) The agency may publish an order of prohibition with a shorter 
comment period and/or delayed effective date than specified in paragraph 
(b) of this section in exceptional circumstances (e.g., where there is 
immediate risk to the public health), provided that the order of 
prohibition states that the comment period and/or effective date have 
been abbreviated because there are exceptional circumstances, and the 
order of prohibition sets forth the agency's rationale for taking such 
action.
    (e) If FDA publishes a notice in the Federal Register modifying an 
order of prohibition, the agency will specify in the modified order of 
prohibition the nature and extent of the modified prohibition, the 
reasons for it, and the agency's response to any comments on the 
original order of prohibition.
    (f) A current listing of drugs prohibited for extralabel use in 
animals will be codified in Sec. 530.41.
    (g) After the submission of appropriate information (i.e., adequate 
data, an acceptable method, approval of a new animal drug application 
for the prohibited extralabel use, or information demonstrating that the 
prohibition was based on incorrect data), FDA may, by publication of an 
appropriate notice in the Federal Register, remove a drug from the list 
of human and animal drugs prohibited for extralabel use in animals, or 
may modify a prohibition.
    (h) FDA may prohibit extralabel use of a drug in food-producing 
animals without establishing a safe level.



   Subpart D_Extralabel Use of Human and Animal Drugs in Animals Not 
                     Intended for Human Consumption



Sec. 530.30  Extralabel drug use in nonfood animals.

    (a) Because extralabel use of animal and human drugs in nonfood-
producing animals does not ordinarily pose a threat to the public 
health, extralabel use of animal and human drugs is permitted in 
nonfood-producing animal practice except when the public health is 
threatened. In addition, the provisions of Sec. 530.20(a)(1) will apply 
to the use of an approved animal drug.
    (b) If FDA determines that an extralabel drug use in animals not 
intended for human consumption presents a risk to the public health, the 
agency may publish in the Federal Register a notice prohibiting such use 
following the procedures in Sec. 530.25. The prohibited extralabel drug 
use will be codified in Sec. 530.41.



 Subpart E_Safe Levels for Extralabel Use of Drugs in Animals and Drugs 
                Prohibited From Extralabel Use in Animals



Sec. 530.40  Safe levels and availability of analytical methods.

    (a) In accordance with Sec. 530.22, the following safe levels for 
extralabel use of an approved animal drug or human drug have been 
established: [Reserved]
    (b) In accordance with Sec. 530.22, the following analytical 
methods have been accepted by FDA: [Reserved]



Sec. 530.41  Drugs prohibited for extralabel use in animals.

    (a) The following drugs, families of drugs, and substances are 
prohibited

[[Page 399]]

for extralabel animal and human drug uses in food-producing animals.
    (1) Chloramphenicol;
    (2) Clenbuterol;
    (3) Diethylstilbestrol (DES);
    (4) Dimetridazole;
    (5) Ipronidazole;
    (6) Other nitroimidazoles;
    (7) Furazolidone.
    (8) Nitrofurazone.
    (9) Sulfonamide drugs in lactating dairy cattle (except approved use 
of sulfadimethoxine, sulfabromomethazine, and sulfaethoxypyridazine);
    (10) Fluoroquinolones; and
    (11) Glycopeptides.
    (12) Phenylbutazone in female dairy cattle 20 months of age or 
older.
    (13) Cephalosporins (not including cephapirin) in cattle, swine, 
chickens, or turkeys:
    (i) For disease prevention purposes;
    (ii) At unapproved doses, frequencies, durations, or routes of 
administration; or
    (iii) If the drug is not approved for that species and production 
class.
    (b) The following drugs, families of drugs, and substances are 
prohibited for extralabel animal and human drug uses in nonfood-
producing animals: [Reserved]
    (c) [Reserved]
    (d) The following drugs, or classes of drugs, that are approved for 
treating or preventing influenza A, are prohibited from extralabel use 
in chickens, turkeys, and ducks:
    (1) Adamantanes.
    (2) Neuraminidase inhibitors.

[62 FR 27947, May 22, 1997, as amended at 67 FR 5471, Feb. 6, 2002; 68 
FR 9530, Feb. 28, 2003; 68 FR 14134, Mar. 24, 2003; 71 FR 14377, Mar. 
22, 2006; 77 FR 745, Jan. 6, 2012]



PART 556_TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD
--Table of Contents



                      Subpart A_General Provisions

Sec.
556.1 Scope.
556.3 Definitions.
556.5 General considerations.

Subpart B_Specific Tolerances for Residues of Approved and Conditionally 
                        Approved New Animal Drugs

556.34 Albendazole.
556.36 Altrenogest.
556.38 Amoxicillin.
556.40 Ampicillin.
556.50 Amprolium.
556.52 Apramycin.
556.60 Avilamycin.
556.68 Azaperone.
556.70 Bacitracin.
556.75 Bambermycins.
556.100 Carbadox.
556.110 Carbomycin.
556.113 Ceftiofur.
556.115 Cephapirin.
556.118 Chloramine-T.
556.120 Chlorhexidine.
556.150 Chlortetracycline.
556.160 Clopidol.
556.163 Clorsulon.
556.165 Cloxacillin.
556.167 Colistimethate.
556.168 Coumaphos.
556.169 Danofloxacin.
556.170 Decoquinate.
556.180 Dichlorvos.
556.185 Diclazuril.
556.200 Dihydrostreptomycin.
556.222 Doramectin.
556.224 Efrotomycin.
556.226 Enrofloxacin.
556.227 Eprinomectin.
556.230 Erythromycin.
556.240 Estradiol and related esters.
556.260 Ethopabate.
556.273 Famphur.
556.275 Fenbendazole.
556.277 Fenprostalene.
556.280 Fenthion.
556.283 Florfenicol.
556.286 Flunixin.
556.292 Gamithromycin.
556.300 Gentamicin.
556.304 Gonadotropin.
556.308 Halofuginone.
556.310 Haloxon.
556.316 Hetacillin.
556.330 Hygromycin B.
556.344 Ivermectin.
556.346 Laidlomycin.
556.347 Lasalocid.
556.350 Levamisole.
556.360 Lincomycin.
556.370 Lubabegron.
556.375 Maduramicin.
556.380 Melengestrol.
556.410 Metoserpate.
556.420 Monensin.
556.425 Morantel.
556.426 Moxidectin.
556.428 Narasin.
556.430 Neomycin.

[[Page 400]]

556.445 Nicarbazin.
556.460 Novobiocin.
556.470 Nystatin.
556.490 Ormetoprim.
556.495 Oxfendazole.
556.500 Oxytetracycline.
556.510 Penicillin.
556.515 Pirlimycin.
556.517 Poloxalene.
556.540 Progesterone.
556.560 Pyrantel.
556.570 Ractopamine.
556.580 Robenidine.
556.592 Salinomycin.
556.597 Semduramicin.
556.600 Spectinomycin.
556.610 Streptomycin.
556.620 Sulfabromomethazine.
556.625 Sulfachloropyrazine.
556.630 Sulfachlorpyridazine.
556.640 Sulfadimethoxine.
556.650 Sulfaethoxypyridazine.
556.660 Sulfamerazine.
556.670 Sulfamethazine.
556.685 Sulfaquinoxaline.
556.700 Sulfomyxin.
556.710 Testosterone.
556.720 Tetracycline.
556.730 Thiabendazole.
556.732 Tiamulin.
556.733 Tildipirosin.
556.735 Tilmicosin.
556.739 Trenbolone.
556.741 Tripelennamine.
556.745 Tulathromycin.
556.746 Tylosin.
556.748 Tylvalosin.
556.750 Virginiamycin.
556.760 Zeranol.
556.765 Zilpaterol.
556.770 Zoalene.

    Authority: 21 U.S.C. 342, 360b, 371.

    Source: 84 FR 32993, July 11, 2019, unless otherwise noted.



                      Subpart A_General Provisions



Sec. 556.1  Scope.

    (a) The Federal Food, Drug, and Cosmetic Act requires an applicant 
seeking approval or conditional approval of a new animal drug to submit 
a proposed tolerance as part of its new animal drug application when 
such a tolerance is needed to assure that the proposed use of the new 
animal drug will be safe (see sections 512(b)(1)(H) and 571(a)(2)(A) of 
the Federal Food, Drug, and Cosmetic Act). FDA assigns tolerances for 
animal drugs used in food-producing animals as part of the application 
approval process. Tolerances for approved and conditionally approved new 
animal drugs are codified in subpart B of this part.
    (b) Compounds that have been found to be carcinogenic are regulated 
under subpart E of part 500 of this chapter.



Sec. 556.3  Definitions.

    As used in this part:
    Acceptable daily intake (ADI) means the daily intake which, during 
up to an entire life of a human, appears to be without adverse effects 
or harm to the health of the consumer. The ADI most often will be set on 
the basis of the drug's toxicological, microbiological, or 
pharmacological properties. It is usually expressed in micrograms or 
milligrams of the chemical per kilogram of body weight per day.
    Acute reference dose (ARfD) means an estimate of the amount of 
residues expressed on a body weight basis that can be ingested in a 
period of 24 hours or less without adverse effects or harm to the health 
of the human consumer.
    Edible tissues means muscle, liver, kidney, fat, skin with fat in 
natural proportions, whole eggs, whole milk, and honey.
    Marker residue means the residue whose concentration is in a known 
relationship to the concentration of total residue in an edible tissue.
    mg/kg means milligrams per kilogram.
    Not required, in reference to tolerances in this part, means that at 
the time of approval:
    (1) No withdrawal period was necessary for residues of the drug to 
deplete to or below the concentrations considered to be safe, or an 
adequate withdrawal period was inherent in the proposed drug use, and 
there was a rapid depletion of residues, so there was no concern about 
residues resulting from misuse or overdosing; or
    (2) No withdrawal period was necessary because the drug was poorly 
absorbed or metabolized rapidly so as to make selection of an analyte 
impractical or impossible.
    ppb means parts per billion (equivalent to nanograms per gram (ng/g) 
or [micro]g/kg).
    ppm means parts per million (equivalent to micrograms per gram 
([micro]g/g) or mg/kg).

[[Page 401]]

    ppt means parts per trillion (equivalent to picograms per gram (pg/
g) or nanograms per kilogram (ng/kg)).
    Residue means any compound present in edible tissues that results 
from the use of a drug, and includes the drug, its metabolites, and any 
other substance formed in or on food because of the drug's use.
    Target tissue means the edible tissue selected to monitor for 
residues in the target animals.
    Tolerance means the maximum concentration of a marker residue, or 
other residue indicated for monitoring, that can legally remain in a 
specific edible tissue of a treated animal.
    Total residue means the aggregate of all compounds that results from 
the use of an animal drug, including the drug, its metabolites, and any 
other substances formed in or on food because of such drug use.
    [micro]g/kg means microgram per kilogram.
    Zero, in reference to tolerances in this part, means any residues 
detected in the edible tissue renders it unsafe.



Sec. 556.5  General considerations.

    (a) The tolerances listed in subpart B of this part pertain only to 
the species and production classes of the animal for which the drug use 
has been approved or conditionally approved. Approved and conditionally 
approved conditions of use in parts 516, 520, 522, 524, 526, 529, and 
558 of this chapter, including the species and production classes of 
animals, are referenced in each tolerance section in subpart B of this 
part.
    (b) All tolerances refer to the concentrations of a marker residue, 
or other residue indicated for monitoring, permitted in uncooked 
tissues.
    (c) After a tolerance is listed, the finding that the concentration 
of the marker residue in the target tissue from a tested animal is at or 
below the tolerance indicates that all edible tissues (excluding milk 
and eggs unless otherwise indicated) from that tested animal are safe 
for human consumption. If a listed tolerance is not expressly linked to 
a target tissue, then the tolerance is specific only for the named 
edible tissue and inferences cannot be made about the safety of the 
other edible tissues from the tested animal.
    (d) FDA requires that a drug sponsor submit a practicable method as 
part of their new animal drug application. FDA uses the practicable 
method to determine the quantity of the drug residues that can safely 
remain in edible tissues (i.e., the tolerance), the withdrawal period, 
and any other use restrictions necessary to ensure that the proposed use 
of the drug will be safe.



Subpart B_Specific Tolerances for Residues of Approved and Conditionally 
                        Approved New Animal Drugs



Sec. 556.34  Albendazole.

    (a) Acceptable daily intake (ADI). The ADI for total residue of 
albendazole is 5 [micro]g/kg of body weight per day.
    (b) Tolerances. The tolerances for albendazole 2-aminosulfone 
(marker residue) are:
    (1) Cattle. (i) Liver (target tissue): 0.2 ppm.
    (ii) Muscle: 0.05 ppm.
    (2) Sheep. (i) Liver (target tissue): 0.25 ppm.
    (ii) Muscle: 0.05 ppm.
    (3) Goat. (i) Liver (target tissue): 0.25 ppm.
    (ii) [Reserved]
    (c) Related conditions of use. See Sec. Sec. 520.38a and 520.38b of 
this chapter.



Sec. 556.36  Altrenogest.

    (a) Acceptable daily intake (ADI). The ADI for total residue of 
altrenogest is 0.04 [micro]g/kg of body weight per day.
    (b) Tolerances. The tolerances for altrenogest (marker residue) are:
    (1) Swine. (i) Liver (target tissue): 4 ppb.
    (ii) Muscle: 1 ppb.
    (2) [Reserved]
    (c) Related conditions of use. See Sec. 520.48 of this chapter.



Sec. 556.38  Amoxicillin.

    (a) [Reserved]
    (b) Tolerances. The tolerance for amoxicillin is:
    (1) Cattle. Edible tissues: 0.01 ppm.
    (2) [Reserved]

[[Page 402]]

    (c) Related conditions of use. See Sec. Sec. 520.88d, 520.88e, 
522.88, and 526.88 of this chapter.

[84 FR 32993, July 11, 2019, as amended at 86 FR 13188, Mar. 8, 2021]



Sec. 556.40  Ampicillin.

    (a) [Reserved]
    (b) Tolerances. The tolerances for ampicillin are:
    (1) Cattle. Edible tissues: 0.01 ppm.
    (2) Swine. Edible tissues: 0.01 ppm.
    (c) Related conditions of use. See Sec. Sec. 520.90c, 522.90a, and 
522.90b of this chapter.

[84 FR 32993, July 11, 2019, as amended at 85 FR 18120, Apr. 1, 2020]



Sec. 556.50  Amprolium.

    (a) [Reserved]
    (b) Tolerances. The tolerances for amprolium are:
    (1) Cattle. (i) Liver, kidney, and muscle: 0.5 ppm.
    (ii) Fat: 2.0 ppm.
    (2) Chickens and turkeys. (i) Liver and kidney: 1 ppm.
    (ii) Muscle: 0.5 ppm.
    (iii) Eggs:
    (A) Egg yolks: 8 ppm.
    (B) Whole eggs: 4 ppm.
    (3) Pheasants. (i) Liver: 1 ppm.
    (ii) Muscle: 0.5 ppm.
    (c) Related conditions of use. See Sec. Sec. 520.100, 558.55, and 
558.58 of this chapter.



Sec. 556.52  Apramycin.

    (a) Acceptable daily intake (ADI). The ADI for total residue of 
apramycin is 25 [micro]g/kg of body weight per day.
    (b) Tolerances. The tolerance for apramycin (marker residue) is:
    (1) Swine. Kidney (target tissue): 0.1 ppm.
    (2) [Reserved]
    (c) Related conditions of use. See Sec. Sec. 520.110 and 558.59 of 
this chapter.



Sec. 556.60  Avilamycin.

    (a) Acceptable daily intake (ADI). The ADI for total residue of 
avilamycin is 1.1 mg/kg of body weight per day.
    (b) Tolerances. The tolerances for avilamycin are:
    (1) Chickens. Edible tissues (excluding eggs): Not required.
    (2) Swine. Edible tissues: Not required.
    (c) Related conditions of use. See Sec. 558.68 of this chapter.



Sec. 556.68  Azaperone.

    (a) Acceptable daily intake (ADI). The ADI for total residue of 
azaperone is 0.63 [micro]g/kg of body weight per day.
    (b) Tolerances. The tolerance for azaperone is:
    (1) Swine. Edible tissues: Not required.
    (2) [Reserved]
    (c) Related conditions of use. See Sec. 522.150 of this chapter.



Sec. 556.70  Bacitracin.

    (a) Acceptable daily intake (ADI). The ADI for total residue of 
bacitracin is 0.05 mg/kg of body weight per day.
    (b) Tolerances. The tolerances for bacitracin are:
    (1) Cattle. Edible tissues: 0.5 ppm.
    (2) Chickens, turkeys, pheasants, quail. Edible tissues: 0.5 ppm.
    (3) Swine. Edible tissues: 0.5 ppm.
    (c) Related conditions of use. See Sec. Sec. 520.154a, 520.154c, 
558.76, and 558.78 of this chapter.



Sec. 556.75  Bambermycins.

    (a) [Reserved]
    (b) Tolerances. The tolerances for bambermycins are:
    (1) Cattle. Edible tissues (excluding milk): Not required.
    (2) Chickens and turkeys. Edible tissues (excluding eggs): Not 
required.
    (3) Swine. Edible tissues: Not required.
    (c) Related conditions of use. See Sec. 558.95 of this chapter.



Sec. 556.100  Carbadox.

    (a) [Reserved]
    (b) Tolerances. The tolerance for quinoxaline-2-carboxylic acid 
(marker residue) is:
    (1) Swine. Liver (target tissue): 30 ppb.
    (2) [Reserved]
    (c) Related conditions of use. See Sec. 558.115 of this chapter.



Sec. 556.110  Carbomycin.

    (a) [Reserved]
    (b) Tolerances. The tolerance for carbomycin is:

[[Page 403]]

    (1) Chickens. Edible tissues (excluding eggs): Zero.
    (2) [Reserved]
    (c) Related conditions of use. See Sec. 520.1660a of this chapter.



Sec. 556.113  Ceftiofur.

    (a) Acceptable daily intake and acute reference dose--(1) Acceptable 
daily intake (ADI). The ADI for total residue of ceftiofur is 30 
[micro]g/kg of body weight per day.
    (2) Acute reference dose (ARfD). The ARfD for total residue of 
ceftiofur is 0.830 mg/kg of body weight.
    (b) Tolerances. The tolerances for desfuroylceftiofur (marker 
residue) are:
    (1) Cattle. (i) Kidney (target tissue): 0.4 ppm.
    (ii) Liver: 2 ppm.
    (iii) Muscle: 1 ppm.
    (iv) Milk: 0.1 ppm.
    (2) Chickens and turkeys. Edible tissues (excluding eggs): Not 
required.
    (3) Goats. (i) Kidney (target tissue): 8 ppm.
    (ii) Liver: 2 ppm.
    (iii) Muscle: 1 ppm.
    (iv) Milk: 0.1 ppm.
    (4) Sheep. Edible tissues (excluding milk): Not required.
    (5) Swine. (i) Kidney (target tissue): 0.25 ppm.
    (ii) Liver: 3 ppm.
    (iii) Muscle: 2 ppm.
    (c) Related conditions of use. See Sec. Sec. 522.313a, 522.313b, 
522.313c, and 526.313 of this chapter.



Sec. 556.115  Cephapirin.

    (a) [Reserved]
    (b) Tolerances. The tolerances for cephapirin are:
    (1) Cattle. (i) Edible tissues (excluding milk): 0.1 ppm.
    (ii) Milk: 0.02 ppm.
    (2) [Reserved]
    (c) Related conditions of use. See Sec. Sec. 526.363 and 526.365 of 
this chapter.



Sec. 556.118  Chloramine-T.

    (a) Acceptable daily intake (ADI). The ADI for total residue of 
chloramine-T is 5 [micro]g/kg of body weight per day.
    (b) Tolerances. The tolerance for para-toluenesulfonamide (marker 
residue) is:
    (1) Fish. Muscle/skin (target tissue): 0.9 ppm.
    (2) [Reserved]
    (c) Related conditions of use. See Sec. 529.382 of this chapter.



Sec. 556.120  Chlorhexidine.

    (a) [Reserved]
    (b) Tolerances. The tolerance for chlorhexidine is:
    (1) Cattle. Edible tissues (excluding milk): Zero.
    (2) [Reserved]
    (c) Related conditions of use. See Sec. 529.400 of this chapter.



Sec. 556.150  Chlortetracycline.

    (a) Acceptable daily intake (ADI). The ADI for total residue of 
tetracyclines including chlortetracycline, oxytetracycline, and 
tetracycline is 25 [micro]g/kg of body weight per day.
    (b) Tolerances. The tolerances for the sum of tetracycline residues 
are:
    (1) Cattle. (i) Liver: 6 ppm.
    (ii) Kidney and fat: 12 ppm.
    (iii) Muscle: 2 ppm.
    (2) Chickens, turkeys, and ducks. (i) Liver: 6 ppm.
    (ii) Kidney and fat: 12 ppm.
    (iii) Muscle: 2 ppm.
    (iv) Eggs: 0.4 ppm for chlortetracycline only.
    (3) Sheep. (i) Liver: 6 ppm.
    (ii) Kidney and fat: 12 ppm.
    (iii) Muscle: 2 ppm.
    (4) Swine. (i) Liver: 6 ppm.
    (ii) Kidney and fat: 12 ppm.
    (iii) Muscle: 2 ppm.
    (c) Related conditions of use. See Sec. Sec. 520.441, 520.443, 
520.445, 558.128, and 558.140 of this chapter.



Sec. 556.160  Clopidol.

    (a) [Reserved]
    (b) Tolerances. The tolerances for clopidol are:
    (1) Chickens and turkeys. (i) Liver and kidney: 15 ppm.
    (ii) Muscle: 5 ppm.
    (2) [Reserved]
    (c) Related conditions of use. See Sec. 558.175 of this chapter.



Sec. 556.163  Clorsulon.

    (a) Acceptable daily intake (ADI). The ADI for total residue of 
clorsulon is 8 [micro]g/kg of body weight per day.

[[Page 404]]

    (b) Tolerances. The tolerances for clorsulon (marker residue) are:
    (1) Cattle. (i) Kidney (target tissue): 1.0 ppm.
    (ii) Muscle: 0.1 ppm.
    (2) [Reserved]
    (c) Related conditions of use. See Sec. Sec. 520.462 and 522.1193 
of this chapter.



Sec. 556.165  Cloxacillin.

    (a) [Reserved]
    (b) Tolerances. The tolerance for cloxacillin is:
    (1) Cattle. Edible tissues: 0.01 ppm.
    (2) [Reserved]
    (c) Related conditions of use. See Sec. Sec. 526.464 and 526.465 of 
this chapter.

[84 FR 32993, July 11, 2019, as amended at 85 FR 18121, Apr. 1, 2020; 86 
FR 13188, Mar. 8, 2021]



Sec. 556.167  Colistimethate.

    (a) [Reserved]
    (b) Tolerances. The tolerance for colistimethate is:
    (1) Chickens. Edible tissues (excluding eggs): Not required.
    (2) [Reserved]
    (c) Related conditions of use. See Sec. 522.468 of this chapter.



Sec. 556.168  Coumaphos.

    (a) [Reserved]
    (b) Tolerances. The tolerances for coumaphos (measured as coumaphos 
and its oxygen analog, O,O-diethyl O-3- chloro-4-methyl-2-oxo-2 H-1- 
benzopyran-7-yl phosphate) are:
    (1) Chickens. (i) Edible tissues (excluding eggs): 1 ppm.
    (ii) Eggs: 0.1 ppm.
    (2) [Reserved]
    (c) Related conditions of use. See Sec. 558.185 of this chapter.

[86 FR 14821, Mar. 19, 2021]



Sec. 556.169  Danofloxacin.

    (a) Acceptable daily intake (ADI). The ADI for total residue of 
danofloxacin is 2.4 [micro]g/kg of body weight per day.
    (b) Tolerances. The tolerances for danofloxacin (marker residue) 
are:
    (1) Cattle. (i) Liver (target tissue): 0.2 ppm.
    (ii) Muscle: 0.2 ppm.
    (2) [Reserved]
    (c) Related conditions of use. See Sec. 522.522 of this chapter.



Sec. 556.170  Decoquinate.

    (a) Acceptable daily intake (ADI). The ADI for total residue of 
decoquinate is 75 [micro]g/kg of body weight per day.
    (b) Tolerances. The tolerances for decoquinate are:
    (1) Cattle. (i) Muscle: 1 ppm.
    (ii) Other edible tissues (excluding milk): 2 ppm.
    (2) Chickens. (i) Muscle: 1 ppm.
    (ii) Other edible tissues (excluding eggs): 2 ppm.
    (3) Goats. (i) Muscle: 1 ppm.
    (ii) Other edible tissues (excluding milk): 2 ppm.
    (c) Related conditions of use. See Sec. Sec. 520.534 and 558.195 of 
this chapter.

[84 FR 32993, July 11, 2019, as amended at 86 FR 13188, Mar. 8, 2021]



Sec. 556.180  Dichlorvos.

    (a) [Reserved]
    (b) Tolerances. The tolerance for dichlorvos is:
    (1) Swine. Edible tissues: 0.1 ppm.
    (2) [Reserved]
    (c) Related conditions of use. See Sec. Sec. 520.596 and 558.198 of 
this chapter.

[84 FR 32993, July 11, 2019, as amended at 86 FR 13188, Mar. 8, 2021]



Sec. 556.185  Diclazuril.

    (a) Acceptable daily intake (ADI). The ADI for total residue of 
diclazuril is 25 [micro]g/kg of body weight per day.
    (b) Tolerances. The tolerances for diclazuril are:
    (1) Chickens and turkeys. (i) Liver: 3 ppm.
    (ii) Muscle: 0.5 ppm.
    (iii) Skin/fat: 1 ppm.
    (2) [Reserved]
    (c) Related conditions of use. See Sec. 558.205 of this chapter.

[84 FR 32993, July 11, 2019, as amended at 86 FR 13188, Mar. 8, 2021]



Sec. 556.200  Dihydrostreptomycin.

    (a) [Reserved]
    (b) Tolerances. The tolerances for dihydrostreptomycin are:
    (1) Cattle. (i) Kidney: 2.0 ppm.
    (ii) Other edible tissues (excluding milk): 0.5 ppm.
    (iii) Milk: 0.125 ppm.
    (2) Swine. (i) Kidney: 2.0 ppm.
    (ii) Other edible tissues: 0.5 ppm.

[[Page 405]]

    (c) Related conditions of use. See Sec. Sec. 522.650, 526.1696b, 
and 526.1696c of this chapter.



Sec. 556.222  Doramectin.

    (a) Acceptable daily intake (ADI). The ADI for total residue of 
doramectin is 0.75 [micro]g/kg of body weight per day.
    (b) Tolerances. The tolerances for doramectin (marker residue) are:
    (1) Cattle. (i) Liver (target tissue): 100 ppb.
    (ii) Muscle: 30 ppb.
    (2) Swine. Liver (target tissue): 160 ppb.
    (c) Related conditions of use. See Sec. Sec. 522.770 and 524.770 of 
this chapter.



Sec. 556.224  Efrotomycin.

    (a) Acceptable daily intake (ADI). The ADI for total residue of 
efrotomycin is 10 [micro]g/kg of body weight per day.
    (b) Tolerances. The tolerance for efrotomycin is:
    (1) Swine. Edible tissues: Not required.
    (2) [Reserved]
    (c) Related conditions of use. See Sec. 558.235 of this chapter.



Sec. 556.226  Enrofloxacin.

    (a) Acceptable daily intake (ADI). The ADI for total residue of 
enrofloxacin is 3 [micro]g/kg of body weight per day.
    (b) Tolerances. The tolerances for enrofloxacin are:
    (1) Cattle. Liver (target tissue): 0.1 ppm desethylene ciprofloxacin 
(marker residue).
    (2) Swine. Liver (target tissue): 0.5 ppm enrofloxacin (marker 
residue).
    (c) Related conditions of use. See Sec. Sec. 516.812 and 522.812 of 
this chapter.

[84 FR 32993, July 11, 2019, as amended at 86 FR 13188, Mar. 8, 2021]



Sec. 556.227  Eprinomectin.

    (a) Acceptable daily intake (ADI). The ADI for total residue of 
eprinomectin is 10 [micro]g/kg of body weight per day.
    (b) Tolerances. The tolerances for eprinomectin B1a 
(marker residue) are:
    (1) Cattle. (i) Liver (target tissue): 1.5 ppm.
    (ii) Muscle: 100 ppb.
    (iii) Milk: 12 ppb.
    (2) [Reserved]
    (c) Related conditions of use. See Sec. Sec. 522.814 and 524.814 of 
this chapter.



Sec. 556.230  Erythromycin.

    (a) [Reserved]
    (b) Tolerances. The tolerances for erythromycin are:
    (1) Cattle. (i) Edible tissues (excluding milk): 0.1 ppm.
    (ii) Milk: Zero.
    (2) Chickens and turkeys. (i) Edible tissues (excluding eggs): 0.125 
ppm.
    (ii) Eggs: 0.025 ppm.
    (c) Related conditions of use. See Sec. Sec. 520.823, 522.820, 
526.820, and 558.248 of this chapter.

[84 FR 32993, July 11, 2019, as amended at 85 FR 18121, Apr. 1, 2020]



Sec. 556.240  Estradiol and related esters.

    (a) [Reserved]
    (b) Residues. Residues of estradiol are not permitted in excess of 
the following increments above the concentrations of estradiol naturally 
present in untreated animals:
    (1) Cattle. (i) Muscle: 120 ppt.
    (ii) Fat: 480 ppt.
    (iii) Kidney: 360 ppt.
    (iv) Liver: 240 ppt.
    (2) [Reserved]
    (c) Related conditions of use. See Sec. Sec. 522.840, 522.842, 
522.850, 522.1940, 522.2477, and 522.2478 of this chapter.



Sec. 556.260  Ethopabate.

    (a) [Reserved]
    (b) Tolerances. The tolerances for ethopabate, measured as 
metaphenetidine, are:
    (1) Chickens. (i) Liver: 1.5 ppm.
    (ii) Kidney: 1.5 ppm.
    (iii) Muscle: 0.5 ppm.
    (2) [Reserved]
    (c) Related conditions of use. See Sec. 558.58 of this chapter.



Sec. 556.273  Famphur.

    (a) [Reserved]
    (b) Tolerances. The tolerance for famphur including its oxygen 
analog is:
    (1) Cattle. Edible tissues (excluding milk): 0.1 ppm.
    (2) [Reserved]
    (c) Related conditions of use. See Sec. Sec. 520.1242g, 524.900, 
and 558.254 of this chapter.

[[Page 406]]



Sec. 556.275  Fenbendazole.

    (a) Acceptable daily intake (ADI). The ADI for total residue of 
fenbendazole is 40 [micro]g/kg of body weight per day.
    (b) Tolerances. The tolerances for fenbendazole are:
    (1) Cattle. (i) Liver (target tissue): 0.8 ppm fenbendazole (marker 
residue).
    (ii) Muscle: 0.4 ppm fenbendazole.
    (iii) Milk: 0.6 ppm fenbendazole sulfoxide.
    (2) Chickens. (i) Liver (target tissue): 5.2 ppm fenbendazole 
sulfone (marker residue).
    (ii) Eggs: 1.8 ppm fenbendazole sulfone (marker residue).
    (3) Goats. (i) Liver (target tissue): 0.8 ppm fenbendazole (marker 
residue).
    (ii) Muscle: 0.4 ppm fenbendazole.
    (4) Swine. (i) Liver (target tissue): 3.2 ppm fenbendazole (marker 
residue).
    (ii) Muscle: 2 ppm fenbendazole.
    (5) Turkeys. (i) Liver (target tissue): 6 ppm fenbendazole sulfone 
(marker residue).
    (ii) Muscle: 2 ppm fenbendazole sulfone.
    (c) Related conditions of use. See Sec. Sec. 520.905a, 520.905c, 
520.905d, 520.905e, and 558.258 of this chapter.



Sec. 556.277  Fenprostalene.

    (a) Acceptable daily intake (ADI). The ADI for total residue of 
fenprostalene is 0.08 [micro]g/kg of body weight per day.
    (b) Tolerances. The tolerances for fenprostalene are:
    (1) Cattle. Edible tissues (excluding milk): Not required.
    (2) Swine. Edible tissues: Not required.
    (c) Related conditions of use. See Sec. 522.914 of this chapter.



Sec. 556.280  Fenthion.

    (a) [Reserved]
    (b) Tolerances. The tolerance for fenthion is:
    (1) Cattle. Edible tissues (excluding milk): 0.1 ppm.
    (2) [Reserved]
    (c) Related conditions of use. See Sec. 524.920 of this chapter.



Sec. 556.283  Florfenicol.

    (a) Acceptable daily intake (ADI). The ADI for total residue of 
florfenicol is 10 [micro]g/kg of body weight per day.
    (b) Tolerances. The tolerances for florfenicol amine (marker 
residue) are:
    (1) Cattle. (i) Liver (target tissue): 3.7 ppm.
    (ii) Muscle: 0.3 ppm.
    (2) Swine. (i) Liver (target tissue): 2.5 ppm.
    (ii) Muscle: 0.2 ppm.
    (3) Catfish. Muscle (target tissue): 1 ppm.
    (4) Freshwater-reared warmwater finfish (other than catfish) and 
salmonids. Muscle/skin (target tissue): 1 ppm.
    (c) Related conditions of use. See Sec. Sec. 520.955, 522.955, 
522.956, and 558.261 of this chapter.



Sec. 556.286  Flunixin.

    (a) Acceptable daily intake (ADI). The ADI for total residue of 
flunixin is 0.72 [micro]g/kg of body weight per day.
    (b) Tolerances. The tolerances for flunixin are:
    (1) Cattle. (i) Liver (target tissue): 125 ppb flunixin free acid 
(marker residue).
    (ii) Muscle: 25 ppb flunixin free acid.
    (iii) Milk: 2 ppb 5-hydroxy flunixin (marker residue).
    (2) Swine. (i) Liver (target tissue): 30 ppb flunixin free acid 
(marker residue).
    (ii) Muscle: 25 ppb flunixin free acid.
    (c) Related conditions of use. See Sec. Sec. 522.956, 522.970, 
522.1664, and 524.970 of this chapter.



Sec. 556.292  Gamithromycin.

    (a) Acceptable daily intake (ADI). The ADI for total residue of 
gamithromycin is 10 [micro]g/kg of body weight per day.
    (b) Tolerances. The tolerances for gamithromycin (marker residue) 
are:
    (1) Cattle. (i) Liver (target tissue): 500 ppb.
    (ii) Muscle: 150 ppb.
    (2) [Reserved]
    (c) Related conditions of use. See Sec. 522.1014 of this chapter.



Sec. 556.300  Gentamicin.

    (a) Acceptable daily intake (ADI). The ADI for total residue of 
gentamicin is 60 [micro]g/kg of body weight per day.
    (b) Tolerances. The tolerances for gentamicin are:
    (1) Chickens and turkeys. Edible tissues (excluding eggs): 0.1 ppm.
    (2) Swine. (i) Liver: 0.3 ppm.

[[Page 407]]

    (ii) Kidney (target tissue): 0.4 ppm gentamicin (marker residue).
    (iii) Fat: 0.4 ppm.
    (iv) Muscle: 0.1 ppm.
    (c) Related conditions of use. See Sec. Sec. 520.1044a, 520.1044b, 
520.1044c, 522.1044, 524.1044e, and 529.1044b of this chapter.

[84 FR 32993, July 11, 2019, as amended at 86 FR 13188, Mar. 8, 2021]



Sec. 556.304  Gonadotropin.

    (a) Acceptable daily intake (ADI). The ADI for residues of total 
gonadotropins (human chorionic gonadotropin and pregnant mare serum 
gonadotropin) is 42.25 International Units per kilogram of body weight 
per day.
    (b) Tolerances. The tolerances for gonadotropin are:
    (1) Cattle. Edible tissues (excluding milk): Not required.
    (2) Fish. Edible tissues: Not required.
    (3) Swine. Edible tissues: Not required.
    (c) Related conditions of use. See Sec. Sec. 522.1079 and 522.1081 
of this chapter.

[84 FR 32993, July 11, 2019, as amended at 85 FR 18121, Apr. 1, 2020]



Sec. 556.308  Halofuginone.

    (a) Acceptable daily intake (ADI). The ADI for total residue of 
halofuginone hydrobromide is 0.7 [micro]g/kg of body weight per day.
    (b) Tolerances. The tolerances for halofuginone (marker residue) 
are:
    (1) Chickens. Liver (target tissue): 0.16 ppm.
    (2) Turkeys. Liver (target tissue): 0.13 ppm.
    (c) Related conditions of use. See Sec. 558.265 of this chapter.



Sec. 556.310  Haloxon.

    (a) [Reserved]
    (b) Tolerances. The tolerance for haloxon is:
    (1) Cattle. Edible tissues (excluding milk): 0.1 ppm.
    (2) [Reserved]
    (c) Related conditions of use. See Sec. Sec. 520.1120a and 
520.1120b of this chapter.



Sec. 556.316  Hetacillin.

    (a) [Reserved]
    (b) Tolerances. The tolerances for ampicillin (marker residue for 
hetacillin) are:
    (1) Cattle. Edible tissues: 0.01 ppm.
    (2) [Reserved]
    (c) Related conditions of use. See Sec. 526.1130 of this chapter.

[84 FR 53311, Oct. 7, 2019]



Sec. 556.330  Hygromycin B.

    (a) [Reserved]
    (b) Tolerances. The tolerances for hygromycin B are:
    (1) Chickens. Edible tissues: Zero.
    (2) Swine. Edible tissues: Zero.
    (c) Related conditions of use. See Sec. 558.274 of this chapter.



Sec. 556.344  Ivermectin.

    (a) Acceptable daily intake (ADI). The ADI for total residue of 
ivermectin is 5 [micro]g/kg of body weight per day.
    (b) Tolerances. The tolerances for 22,23-dihydroavermectin 
B1a (marker residue) are:
    (1) American bison. Liver (target tissue): 15 ppb.
    (2) Cattle. (i) Liver (target tissue): 1.6 ppm.
    (ii) Muscle: 650 ppb.
    (3) Reindeer. Liver (target tissue): 15 ppb.
    (4) Sheep. Liver (target tissue): 30 ppb.
    (5) Swine. (i) Liver (target tissue): 20 ppb.
    (ii) Muscle: 20 ppb.
    (c) Related conditions of use. See Sec. Sec. 520.1192, 520.1195, 
520.1197, 522.1192, 522.1193, 524.1193, and 558.300 of this chapter.

[84 FR 32993, July 11, 2019, as amended at 85 FR 18121, Apr. 1, 2020]



Sec. 556.346  Laidlomycin.

    (a) Acceptable daily intake (ADI). The ADI for total residue of 
laidlomycin is 7.5 [micro]g/kg of body weight per day.
    (b) Tolerances. The tolerance for laidlomycin (marker residue) is:
    (1) Cattle. Liver (target tissue): 0.2 ppm.
    (2) [Reserved]
    (c) Related conditions of use. See Sec. 558.305 of this chapter.



Sec. 556.347  Lasalocid.

    (a) Acceptable daily intake (ADI). The ADI for total residue of 
lasalocid is 10 [micro]g/kg of body weight per day.

[[Page 408]]

    (b) Tolerances. The tolerances for lasalocid (marker residue) are:
    (1) Cattle. Liver (target tissue): 0.7 ppm.
    (2) Chickens. (i) Skin with adhering fat (target tissue): 1.2 ppm.
    (ii) Liver: 0.4 ppm.
    (3) Rabbits. Liver (target tissue): 0.7 ppm.
    (4) Sheep. Liver (target tissue): 1.0 ppm.
    (5) Turkeys. (i) Liver (target tissue): 0.4 ppm.
    (ii) Skin with adhering fat: 0.4 ppm.
    (c) Related conditions of use. See Sec. 558.311 of this chapter.



Sec. 556.350  Levamisole.

    (a) [Reserved]
    (b) Tolerances. The tolerances for levamisole are:
    (1) Cattle. Edible tissues (excluding milk): 0.1 ppm.
    (2) Sheep. Edible tissues (excluding milk): 0.1 ppm.
    (3) Swine. Edible tissues: 0.1 ppm.
    (c) Related conditions of use. See Sec. Sec. 520.1242a, 520.1242b, 
520.1242d, 520.1242e, 520.1242f, 520.1242g, 522.1242, and 524.1240 of 
this chapter.



Sec. 556.360  Lincomycin.

    (a) Acceptable daily intake (ADI). The ADI for total residue of 
lincomycin is 25 [micro]g/kg of body weight per day.
    (b) Tolerances. The tolerances for lincomycin are:
    (1) Chickens. Edible tissues (excluding eggs): Not required.
    (2) Swine. (i) Liver: 0.6 ppm.
    (ii) Muscle: 0.1 ppm.
    (3) Honey. 750 ppb.
    (c) Related conditions of use. See Sec. Sec. 520.1263b, 522.1260, 
and 558.325 of this chapter.

[84 FR 32993, July 11, 2019, as amended at 85 FR 18121, Apr. 1, 2020]

    Editorial Note: At 86 FR 13188, Mar. 8, 2021, in Sec. 556.360, 
paragraph (c) was amended; however, the amendment could not be 
incorporated due to inaccurate amendatory instruction.



Sec. 556.370  Lubabegron.

    (a) Acceptable daily intake (ADI). The ADI for total residues of 
lubabegron is 3 micrograms per kilogram of body weight per day.
    (b) Tolerances. The tolerance for lubabegron (marker residue) is:
    (1) Cattle. Liver (target tissue): 10 ppb.
    (2) [Reserved]
    (c) Related conditions of use. See Sec. 558.330 of this chapter.

[84 FR 12494, Apr. 2, 2019]



Sec. 556.375  Maduramicin.

    (a) [Reserved]
    (b) Tolerances. The tolerance for maduramicin (marker residue) is:
    (1) Chickens. Fat (target tissue): 0.38 ppm.
    (2) [Reserved]
    (c) Related conditions of use. See Sec. 558.340 of this chapter.



Sec. 556.380  Melengestrol.

    (a) [Reserved]
    (b) Tolerances. The tolerance for melengestrol is:
    (1) Cattle. Fat: 25 ppb.
    (2) [Reserved]
    (c) Related conditions of use. See Sec. 558.342 of this chapter.



Sec. 556.410  Metoserpate.

    (a) [Reserved]
    (b) Tolerances. The tolerance for metoserpate is:
    (1) Chickens. Edible tissues (excluding eggs): 0.02 ppm.
    (2) [Reserved]
    (c) Related conditions of use. See Sec. 520.1422 of this chapter.



Sec. 556.420  Monensin.

    (a) Acceptable daily intake (ADI). The ADI for total residue of 
monensin is 12.5 [micro]g/kg of body weight per day.
    (b) Tolerances. The tolerances for monensin are:
    (1) Cattle. (i) Liver: 0.10 ppm.
    (ii) Muscle, kidney, and fat: 0.05 ppm.
    (iii) Milk: Not required.
    (2) Chickens and turkeys. Edible tissues (excluding eggs): Not 
required.
    (3) Goats. Edible tissues (excluding milk): 0.05 ppm.
    (4) Quail. Edible tissues (excluding eggs): Not required.
    (c) Related conditions of use. See Sec. 558.355 of this chapter.

[[Page 409]]



Sec. 556.425  Morantel.

    (a) Acceptable daily intake (ADI). The ADI for total residue of 
morantel tartrate is 10 [micro]g/kg of body weight per day.
    (b) Tolerances. The tolerances for N-methyl-1,3-propanediamine 
(marker residue) are:
    (1) Cattle. (i) Liver (target tissue): 0.7 ppm.
    (ii) Milk: Not required.
    (2) Goats. (i) Liver (target tissue): 0.7 ppm.
    (ii) Milk: Not required.
    (c) Related conditions of use. See Sec. Sec. 520.1450a, 520.1450b, 
520.1450c, and 558.360 of this chapter.



Sec. 556.426  Moxidectin.

    (a) Acceptable daily intake (ADI). The ADI for total residue of 
moxidectin is 4 [micro]g/kg of body weight per day.
    (b) Tolerances. The tolerances for moxidectin (marker residue) are:
    (1) Cattle. (i) Fat (target tissue): 900 ppb.
    (ii) Liver: 200 ppb.
    (iii) Muscle: 50 ppb.
    (iv) Milk: 40 ppb.
    (2) Sheep. (i) Fat (target tissue): 900 ppb.
    (ii) Liver: 200 ppb.
    (iii) Muscle: 50 ppb.
    (c) Related conditions of use. See Sec. Sec. 520.1454, 522.1450, 
and 524.1450 of this chapter.



Sec. 556.428  Narasin.

    (a) Acceptable daily intake (ADI). The ADI for total residue of 
narasin is 5 [micro]g/kg of body weight per day.
    (b) Tolerances. The tolerance for narasin (marker residue) is:
    (1) Chickens. Abdominal fat (target tissue): 480 ppb.
    (2) [Reserved]
    (c) Related conditions of use. See Sec. Sec. 558.363 and 558.364 of 
this chapter.



Sec. 556.430  Neomycin.

    (a) Acceptable daily intake (ADI). The ADI for total residue of 
neomycin is 6 [micro]g/kg of body weight per day.
    (b) Tolerances. The tolerances for neomycin are:
    (1) Cattle. (i) Kidney (target tissue): 7.2 ppm.
    (ii) Liver: 3.6 ppm.
    (iii) Muscle: 1.2 ppm.
    (iv) Fat: 7.2 ppm.
    (v) Milk: 0.15 ppm.
    (2) Sheep and goats. (i) Kidney (target tissue): 7.2 ppm.
    (ii) Liver: 3.6 ppm.
    (iii) Muscle: 1.2 ppm.
    (iv) Fat: 7.2 ppm.
    (v) Milk: 0.15 ppm.
    (3) Swine. (i) Kidney (target tissue): 7.2 ppm.
    (ii) Liver: 3.6 ppm.
    (iii) Muscle: 1.2 ppm.
    (iv) Fat: 7.2 ppm.
    (4) Turkeys. (i) Skin with adhering fat: 7.2 ppm.
    (ii) Liver: 3.6 ppm.
    (iii) Muscle: 1.2 ppm.
    (c) Related conditions of use. See Sec. Sec. 520.1484, 524.1600b, 
558.365, and 558.455 of this chapter.



Sec. 556.445  Nicarbazin.

    (a) Acceptable daily intake (ADI). The ADI for total residues of 
nicarbazin (4,4[min]-dinitrocarbanilide and 2-hydroxy-4,6-
dimethylpyrimidine) is 200 [micro]g/kg of body weight per day.
    (b) Tolerances. The tolerance for 4,4[min]-dinitrocarbanilide 
(marker residue) is:
    (1) Chickens. Liver (target tissue): 52 ppm.
    (2) [Reserved]
    (c) Related conditions of use. See Sec. Sec. 558.364 and 558.366 of 
this chapter.



Sec. 556.460  Novobiocin.

    (a) [Reserved]
    (b) Tolerances. The tolerances for novobiocin are:
    (1) Cattle. (i) Edible tissues (excluding milk): 1 ppm.
    (ii) Milk: 0.1 ppm.
    (2) Chickens, turkeys, and ducks. Edible tissues (excluding eggs): 1 
ppm.
    (c) Related conditions of use. See Sec. Sec. 526.1590, 526.1696d, 
and 558.415 of this chapter.



Sec. 556.470  Nystatin.

    (a) [Reserved]
    (b) Tolerances. The tolerances for nystatin are:
    (1) Cattle. Edible tissues (excluding milk): Zero.
    (2) Chickens and turkeys. Edible tissues: Zero.
    (c) Related conditions of use. See Sec. Sec. 524.1600b and 558.430 
of this chapter.

[[Page 410]]



Sec. 556.490  Ormetoprim.

    (a) [Reserved]
    (b) Tolerances. The tolerances for ormetoprim are:
    (1) Chickens, turkeys, ducks, and chukar partridges. Edible tissues 
(excluding eggs): 0.1 ppm.
    (2) Salmonids and catfish. Edible tissues: 0.1 ppm.
    (c) Related conditions of use. See Sec. 558.575 of this chapter.



Sec. 556.495  Oxfendazole.

    (a) Acceptable daily intake (ADI). The ADI for total residue of 
oxfendazole is 7 [micro]g/kg of body weight per day.
    (b) Tolerances. The tolerance for fenbendazole (marker residue) is:
    (1) Cattle. Liver (target tissue): 0.8 ppm.
    (2) [Reserved]
    (c) Related conditions of use. See Sec. Sec. 520.1629 and 520.1630 
of this chapter.



Sec. 556.500  Oxytetracycline.

    (a) Acceptable daily intake (ADI). The ADI for total tetracycline 
residues (chlortetracycline, oxytetracycline, and tetracycline) is 25 
[micro]g/kg of body weight per day.
    (b) Tolerances. The tolerances for the sum of tetracycline residues 
are:
    (1) Cattle. (i) Muscle: 2 ppm.
    (ii) Liver: 6 ppm.
    (iii) Fat and kidney: 12 ppm.
    (iv) Milk: 0.3 ppm.
    (2) Chickens and turkeys. (i) Muscle: 2 ppm.
    (ii) Liver: 6 ppm.
    (iii) Fat and kidney: 12 ppm.
    (3) Finfish. Muscle (with adhering skin when edible): 2 ppm.
    (4) Lobster. Muscle: 2 ppm.
    (5) Swine and sheep. (i) Muscle: 2 ppm.
    (ii) Liver: 6 ppm.
    (iii) Fat and kidney: 12 ppm.
    (6) Honey. 750 ppb.
    (c) Related conditions of use. See Sec. Sec. 520.1660a, 520.1660c, 
520.1660d, 522.1660a, 522.1660b, 522.1662a, 522.1664, 529.1660, 558.450, 
and 558.455 of this chapter.

[84 FR 32993, July 11, 2019, as amended at 85 FR 18121, Apr. 1, 2020]



Sec. 556.510  Penicillin.

    (a) [Reserved]
    (b) Tolerances. The tolerances for penicillin are:
    (1) Cattle. (i) Edible tissues (excluding milk): 0.05 ppm.
    (ii) Milk: Zero.
    (2) Chickens. Edible tissues: Zero.
    (3) Pheasants and quail. Edible tissues: Zero.
    (4) Sheep and swine. Edible tissues: Zero.
    (5) Turkeys. Edible tissues (excluding eggs): 0.01 ppm.
    (c) Related conditions of use. See Sec. Sec. 520.1696a, 522.1696a, 
522.1696b, 526.1696, 526.1697, and 526.1698 of this chapter.

[84 FR 32993, July 11, 2019, as amended at 85 FR 18121, Apr. 1, 2020; 86 
FR 13188, Mar. 8, 2021]



Sec. 556.515  Pirlimycin.

    (a) Acceptable daily intake (ADI). The ADI for total residue of 
pirlimycin is 0.01 mg/kg of body weight per day.
    (b) Tolerances. The tolerances for pirlimycin (marker residue) are:
    (1) Cattle. (i) Liver (target tissue): 0.5 ppm.
    (ii) Muscle: 0.3 ppm.
    (iii) Milk: 0.4 ppm.
    (2) [Reserved]
    (c) Related conditions of use. See Sec. 526.1810 of this chapter.



Sec. 556.517  Poloxalene.

    (a) [Reserved]
    (b) Tolerances. The tolerance for poloxalene is:
    (1) Cattle. Edible tissues (excluding milk): Not required.
    (2) [Reserved]
    (c) Related conditions of use. See Sec. Sec. 520.1840 and 558.464 
of this chapter.

[84 FR 32993, July 11, 2019, as amended at 86 FR 14821, Mar. 19, 2021]



Sec. 556.540  Progesterone.

    (a) [Reserved]
    (b) Residues. Residues of progesterone are not permitted in excess 
of the following increments above the concentrations of progesterone 
naturally present in untreated animals:
    (1) Cattle and sheep. (i) Muscle: 5 ppb.
    (ii) Liver: 15 ppb.
    (iii) Kidney: 30 ppb.
    (iv) Fat: 30 ppb.
    (2) [Reserved]
    (c) Related conditions of use. See Sec. Sec. 522.1940 and 529.1940 
of this chapter.

[[Page 411]]



Sec. 556.560  Pyrantel.

    (a) [Reserved]
    (b) Tolerances. The tolerances for pyrantel are:
    (1) Swine. (i) Liver and kidney: 10 ppm.
    (ii) Muscle: 1 ppm.
    (2) [Reserved]
    (c) Related conditions of use. See Sec. Sec. 520.2045 and 558.485 
of this chapter.



Sec. 556.570  Ractopamine.

    (a) Acceptable daily intake (ADI). The ADI for total residue of 
ractopamine hydrochloride is 1.25 [micro]g/kg of body weight per day.
    (b) Tolerances. The tolerances for ractopamine (marker residue) are:
    (1) Cattle. (i) Liver (target tissue): 0.09 ppm.
    (ii) Muscle: 0.03 ppm.
    (2) Swine. (i) Liver (target tissue): 0.15 ppm.
    (ii) Muscle: 0.05 ppm.
    (3) Turkeys. (i) Liver (target tissue): 0.45 ppm.
    (ii) Muscle: 0.1 ppm.
    (c) Related conditions of use. See Sec. 558.500 of this chapter.



Sec. 556.580  Robenidine.

    (a) [Reserved]
    (b) Tolerances. The tolerances for robenidine are:
    (1) Chickens. (i) Skin and fat: 0.2 ppm.
    (ii) Other edible tissues (excluding eggs): 0.1 ppm.
    (2) [Reserved]
    (c) Related conditions of use. See Sec. 558.515 of this chapter.



Sec. 556.592  Salinomycin.

    (a) Acceptable daily intake (ADI). The ADI for total residue of 
salinomycin is 5 [micro]g/kg of body weight per day.
    (b) Tolerances. The tolerances for salinomycin are:
    (1) Chickens. Edible tissues (excluding eggs): Not required.
    (2) Quail. Edible tissues (excluding eggs): Not required.
    (c) Related conditions of use. See Sec. 558.550 of this chapter.



Sec. 556.597  Semduramicin.

    (a) Acceptable daily intake (ADI). The ADI for total residue of 
semduramicin is 3 [micro]g/kg of body weight per day.
    (b) Tolerances. The tolerances for semduramicin are:
    (1) Chickens. (i) Liver: 400 ppb.
    (ii) Muscle: 130 ppb.
    (2) [Reserved]
    (c) Related conditions of use. See Sec. 558.555 of this chapter.



Sec. 556.600  Spectinomycin.

    (a) Acceptable daily intake (ADI). The ADI for total residue of 
spectinomycin is 25 [micro]g/kg of body weight per day.
    (b) Tolerances. The tolerances for spectinomycin are:
    (1) Cattle. (i) Kidney (target tissue): 4 ppm spectinomycin (marker 
residue).
    (ii) Muscle: 0.25 ppm.
    (2) Chickens and turkeys. Edible tissues (excluding eggs): 0.1 ppm.
    (3) Swine. Edible tissues: Not required.
    (c) Related conditions of use. See Sec. Sec. 520.1265, 520.2123b, 
520.2123c, 522.2120, and 522.2121 of this chapter.



Sec. 556.610  Streptomycin.

    (a) [Reserved]
    (b) Tolerances. The tolerances for streptomycin are:
    (1) Cattle and swine. (i) Kidney: 2.0 ppm.
    (ii) Other edible tissues (excluding milk): 0.5 ppm.
    (2) Chickens. (i) Kidney: 2.0 ppm.
    (ii) Other edible tissues (excluding eggs): 0.5 ppm.
    (c) Related conditions of use. See Sec. 520.2158 of this chapter.



Sec. 556.620  Sulfabromomethazine.

    (a) [Reserved]
    (b) Tolerances. The tolerances for sulfabromomethazine are:
    (1) Cattle. (i) Edible tissues (excluding milk): 0.1 ppm.
    (ii) Milk: 0.01 ppm.
    (2) [Reserved]
    (c) Related conditions of use. See Sec. 520.2170 of this chapter.



Sec. 556.625  Sulfachloropyrazine.

    (a) [Reserved]
    (b) Tolerances. The tolerance for sulfachloropyrazine is:
    (1) Chickens. Edible tissues (excluding eggs): Zero.
    (2) [Reserved]
    (c) Related conditions of use. See Sec. 520.2184 of this chapter.

[[Page 412]]



Sec. 556.630  Sulfachlorpyridazine.

    (a) [Reserved]
    (b) Tolerances. The tolerances for sulfachlorpyridazine are:
    (1) Cattle and swine. Edible tissues (excluding milk): 0.1 ppm.
    (2) [Reserved]
    (c) Related conditions of use. See Sec. Sec. 520.2200 and 522.2200 
of this chapter.



Sec. 556.640  Sulfadimethoxine.

    (a) [Reserved]
    (b) Tolerances. The tolerances for sulfadimethoxine are:
    (1) Catfish and salmonids. Edible tissues: 0.1 ppm.
    (2) Cattle. (i) Edible tissues (excluding milk): 0.1 ppm.
    (ii) Milk: 0.01 ppm.
    (3) Chickens, turkeys, ducks, and chukar partridges. Edible tissues 
(excluding eggs): 0.1 ppm.
    (c) Related conditions of use. See Sec. Sec. 520.2220a, 520.2220d, 
520.2220e, 522.2220, and 558.575 of this chapter.



Sec. 556.650  Sulfaethoxypyridazine.

    (a) [Reserved]
    (b) Tolerances. The tolerances for sulfaethoxypyridazine are:
    (1) Cattle. (i) Edible tissues (excluding milk): 0.1 ppm.
    (ii) Milk: Zero.
    (2) Swine. Edible tissues: Zero.
    (c) Related conditions of use. See Sec. Sec. 520.2240a, 520.2240b, 
and 522.2240 of this chapter.



Sec. 556.660  Sulfamerazine.

    (a) [Reserved]
    (b) Tolerances. The tolerance for sulfamerazine is:
    (1) Trout. Edible tissues: Zero.
    (2) [Reserved]
    (c) Related conditions of use. See Sec. Sec. 520.2218 and 558.582 
of this chapter.

[84 FR 32993, July 11, 2019, as amended at 85 FR 18121, Apr. 1, 2020]



Sec. 556.670  Sulfamethazine.

    (a) [Reserved]
    (b) Tolerances. The tolerances for sulfamethazine are:
    (1) Cattle. Edible tissues (excluding milk): 0.1 ppm.
    (2) Chickens and turkeys. Edible tissues (excluding eggs): 0.1 ppm.
    (3) Swine. Edible tissues: 0.1 ppm.
    (c) Related conditions of use. See Sec. Sec. 520.445, 520.2218, 
520.2260a, 520.2260b, 520.2260c, 520.2261a, 520.2261b, 522.2260, 
558.140, and 558.630 of this chapter.

[84 FR 32993, July 11, 2019, as amended at 85 FR 18121, Apr. 1, 2020; 86 
FR 13188, Mar. 8, 2021]



Sec. 556.685  Sulfaquinoxaline.

    (a) [Reserved]
    (b) Tolerances. The tolerances for sulfaquinoxaline are:
    (1) Cattle. Edible tissues (excluding milk): 0.1 ppm.
    (2) Chickens and turkeys. Edible tissues (excluding eggs): 0.1 ppm.
    (c) Related conditions of use. See Sec. Sec. 520.2218, 520.2325a, 
520.2325b, and 558.586 of this chapter.

[84 FR 32993, July 11, 2019, as amended at 85 FR 18121, Apr. 1, 2020]



Sec. 556.700  Sulfomyxin.

    (a) [Reserved]
    (b) Tolerances. The tolerances for sulfomyxin are:
    (1) Chickens and turkeys. Edible tissues (excluding eggs): Zero.
    (2) [Reserved]
    (c) Related conditions of use. See Sec. 522.2340 of this chapter.



Sec. 556.710  Testosterone.

    (a) [Reserved]
    (b) Residues. Residues of testosterone are not permitted in excess 
of the following increments above the concentrations of testosterone 
naturally present in untreated animals:
    (1) Cattle. (i) Fat: 2.6 ppb.
    (ii) Kidney: 1.9 ppb.
    (iii) Liver: 1.3 ppb.
    (iv) Muscle: 0.64 ppb.
    (2) [Reserved]
    (c) Related conditions of use. See Sec. 522.842 of this chapter.



Sec. 556.720  Tetracycline.

    (a) Acceptable daily intake (ADI). The ADI for total tetracycline 
residues (chlortetracycline, oxytetracycline, and tetracycline) is 25 
[micro]g/kg of body weight per day.
    (b) Tolerances. The tolerances for the sum of tetracycline residues 
are:
    (1) Cattle and sheep. (i) Kidney and fat: 12 ppm.
    (ii) Liver: 6 ppm.

[[Page 413]]

    (iii) Muscle: 2 ppm.
    (2) Chickens and turkeys. (i) Kidney and fat: 12 ppm.
    (ii) Liver: 6 ppm.
    (iii) Muscle: 2 ppm.
    (3) Swine. (i) Kidney and fat: 12 ppm.
    (ii) Liver: 6 ppm.
    (iii) Muscle: 2 ppm.
    (c) Related conditions of use. See Sec. Sec. 520.2345c and 
520.2345d of this chapter.



Sec. 556.730  Thiabendazole.

    (a) [Reserved]
    (b) Tolerances. The tolerances for thiabendazole are:
    (1) Cattle. (i) Edible tissues (excluding milk): 0.1 ppm.
    (ii) Milk: 0.05 ppm.
    (2) Swine. Edible tissues: 0.1 ppm.
    (3) Sheep and goats. (i) Edible tissues (excluding milk): 0.1 ppm.
    (ii) Milk: 0.05 ppm.
    (4) Pheasants. Edible tissues (excluding eggs): 0.1 ppm.
    (c) Related conditions of use. See Sec. Sec. 520.2380a, 520.2380b, 
520.2380c, and 558.600 of this chapter.



Sec. 556.732  Tiamulin.

    (a) Acceptable daily intake (ADI). The ADI for total residue of 
tiamulin is 25 [micro]g/kg of body weight per day.
    (b) Tolerances. The tolerance for 8-alpha-hydroxymutilin (marker 
residue) is:
    (1) Swine. Liver (target tissue): 0.6 ppm.
    (2) [Reserved]
    (c) Related conditions of use. See Sec. Sec. 520.2455 and 558.612 
of this chapter.



Sec. 556.733  Tildipirosin.

    (a) Acceptable daily intake (ADI). The ADI for total residue of 
tildipirosin is 50 [micro]g/kg of body weight per day.
    (b) Tolerances. The tolerance for tildipirosin (the marker residue) 
is:
    (1) Cattle. (i) Liver (the target tissue): 10 ppm.
    (ii) [Reserved]
    (2) [Reserved]
    (c) Related conditions of use. See Sec. 522.2460 of this chapter.

[84 FR 32993, July 11, 2019, as amended at 85 FR 18121, Apr. 1, 2020]



Sec. 556.735  Tilmicosin.

    (a) Acceptable daily intake (ADI). The ADI for total residue of 
tilmicosin is 25 [micro]g/kg of body weight per day.
    (b) Tolerances. The tolerances for tilmicosin (marker residue) are:
    (1) Cattle. (i) Liver (target tissue): 1.2 ppm.
    (ii) Muscle: 0.1 ppm.
    (2) Sheep. (i) Liver (target tissue): 1.2 ppm.
    (ii) Muscle: 0.1 ppm.
    (3) Swine. (i) Liver (target tissue): 7.5 ppm.
    (ii) Muscle: 0.1 ppm.
    (c) Related conditions of use. See Sec. Sec. 520.2471, 522.2471, 
and 558.618 of this chapter.



Sec. 556.739  Trenbolone.

    (a) Acceptable daily intake (ADI). The ADI for total residue of 
trenbolone is 0.4 [micro]g/kg of body weight per day.
    (b) Tolerances. The tolerance for trenbolone is:
    (1) Cattle. Edible tissues (excluding milk): Not required.
    (2) [Reserved]
    (c) Related conditions of use. See Sec. Sec. 522.2476, 522.2477, 
and 522.2478 of this chapter.



Sec. 556.741  Tripelennamine.

    (a) [Reserved]
    (b) Tolerances. The tolerances for tripelennamine are:
    (1) Cattle. (i) Edible tissues (excluding milk): 200 ppb.
    (ii) Milk: 20 ppb.
    (2) [Reserved]
    (c) Related conditions of use. See Sec. 522.2615 of this chapter.



Sec. 556.745  Tulathromycin.

    (a) Acceptable daily intake (ADI). The ADI for total residue of 
tulathromycin is 15 [micro]g/kg of body weight per day.
    (b) Tolerances. The tolerances for CP-60,300 (marker residue) are:
    (1) Cattle. Liver (target tissue): 5.5 ppm.
    (2) Swine. Kidney (target tissue): 15 ppm.
    (c) Related conditions of use. See Sec. 522.2630 of this chapter.



Sec. 556.746  Tylosin.

    (a) [Reserved]

[[Page 414]]

    (b) Tolerances. The tolerances for tylosin are:
    (1) Cattle. (i) Liver, kidney, fat, and muscle: 0.2 ppm.
    (ii) Milk: 0.05 ppm.
    (2) Chickens and turkeys. (i) Liver, kidney, fat, and muscle: 0.2 
ppm.
    (ii) Eggs: 0.2 ppm.
    (3) Swine. Liver, kidney, fat, and muscle: 0.2 ppm.
    (4) Honey. 500 ppb.
    (c) Related conditions of use. See Sec. Sec. 520.2640, 522.2640, 
558.625, and 558.630 of this chapter.

[84 FR 32993, July 11, 2019, as amended at 85 FR 18121, Apr. 1, 2020]



Sec. 556.748  Tylvalosin.

    (a) Acceptable daily intake (ADI). The ADI for total residues of 
tylvalosin is 47.7 [micro]g/kg of body weight per day.
    (b) Tolerances. A tolerance for tylvalosin in edible tissues of 
swine is not required.
    (c) Related conditions of use. See Sec. Sec. 520.2645 and 558.633 
of this chapter.



Sec. 556.750  Virginiamycin.

    (a) Acceptable daily intake (ADI). The ADI for total residue of 
virginiamycin is 250 [micro]g/kg of body weight per day.
    (b) Tolerances. The tolerances for virginiamycin are:
    (1) Cattle. Edible tissues (excluding milk): Not required.
    (2) Chickens. Edible tissues (excluding eggs): Not required.
    (3) Swine. (i) Kidney, skin, and fat: 0.4 ppm.
    (ii) Liver: 0.3 ppm.
    (iii) Muscle: 0.1 ppm.
    (c) Related conditions of use. See Sec. 558.635 of this chapter.

[84 FR 32993, July 11, 2019, as amended at 85 FR 18121, Apr. 1, 2020]



Sec. 556.760  Zeranol.

    (a) Acceptable daily intake (ADI). The ADI for total residue of 
zeranol is 1.25 [micro]g/kg of body weight per day.
    (b) Tolerances. The tolerances for zeranol are:
    (1) Cattle. Edible tissues (excluding milk): Not required.
    (2) Sheep. Edible tissues (excluding milk): 20 ppb.
    (c) Related conditions of use. See Sec. 522.2680 of this chapter.



Sec. 556.765  Zilpaterol.

    (a) Acceptable daily intake (ADI). The ADI for total residue of 
zilpaterol is 0.083 [micro]g/kg of body weight per day.
    (b) Tolerances. The tolerance for zilpaterol freebase (marker 
residue) is:
    (1) Cattle. (i) Liver (target tissue): 12 ppb.
    (ii) Muscle: 10 ppb.
    (2) [Reserved]
    (c) Related conditions of use. See Sec. 558.665 of this chapter.

[84 FR 32993, July 11, 2019, as amended at 85 FR 18121, Apr. 1, 2020]



Sec. 556.770  Zoalene.

    (a) [Reserved]
    (b) Tolerances. The tolerances for zoalene and its metabolite 3-
amino-5-nitro-o-toluamide are:
    (1) Chickens. (i) Liver and kidney: 6 ppm.
    (ii) Muscle: 3 ppm.
    (iii) Fat: 2 ppm.
    (2) Turkeys. Liver and muscle: 3 ppm.
    (c) Related conditions of use. See Sec. 558.680 of this chapter.



PART 558_NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS--Table of Contents



                      Subpart A_General Provisions

Sec.
558.3 Definitions and general considerations applicable to this part.
558.4 Requirement of a medicated feed mill license.
558.5 Requirements for liquid medicated feed.
558.6 Veterinary feed directive drugs.

       Subpart B_Specific New Animal Drugs For Use in Animal Feeds

558.55 Amprolium.
558.58 Amprolium and ethopabate.
558.59 Apramycin.
558.68 Avilamycin.
558.76 Bacitracin methylenedisalicylate.
558.78 Bacitracin zinc.
558.95 Bambermycins.
558.115 Carbadox.
558.128 Chlortetracycline.
558.140 Chlortetracycline and sulfamethazine.
558.175 Clopidol.
558.185 Coumaphos.
558.195 Decoquinate.
558.198 Dichlorvos.
558.205 Diclazuril.
558.235 Efrotomycin.

[[Page 415]]

558.248 Erythromycin.
558.254 Famphur.
558.258 Fenbendazole.
558.261 Florfenicol.
558.265 Halofuginone hydrobromide.
558.274 Hygromycin B.
558.295 Iodinated casein.
558.300 Ivermectin.
558.305 Laidlomycin.
558.311 Lasalocid.
558.325 Lincomycin.
558.330 Lubabegron.
558.340 Maduramicin.
558.342 Melengestrol.
558.348 Mibolerone.
558.355 Monensin.
558.360 Morantel.
558.363 Narasin.
558.364 Narasin and nicarbazin.
558.365 Neomycin sulfate.
558.366 Nicarbazin.
558.415 Novobiocin.
558.430 Nystatin.
558.450 Oxytetracycline.
558.455 Oxytetracycline and neomycin.
558.464 Poloxalene.
558.470 Polyoxyethylene.
558.485 Pyrantel.
558.500 Ractopamine.
558.515 Robenidine.
558.550 Salinomycin.
558.555 Semduramicin.
558.575 Sulfadimethoxine and ormetoprim.
558.582 Sulfamerazine.
558.586 Sulfaquinoxaline.
558.600 Thiabendazole.
558.612 Tiamulin.
558.618 Tilmicosin.
558.625 Tylosin.
558.630 Tylosin and sulfamethazine.
558.633 Tylvalosin.
558.635 Virginiamycin.
558.665 Zilpaterol.
558.680 Zoalene.

    Authority: 21 U.S.C. 354, 360b, 360ccc, 360ccc-1, 371.

    Source: 40 FR 13959, Mar. 27, 1975, unless otherwise noted.



                      Subpart A_General Provisions



Sec. 558.3  Definitions and general considerations applicable to this
part.

    (a) Regulations in this part provide for approved uses of drugs and 
combinations of drugs in animal feeds. Approved combinations of such 
drugs are specifically identified or incorporated by cross-reference. 
Unless specifically provided for by the regulations, a combination of 
two or more drugs is not approved.
    (b) The following definitions apply to terms used in this part:
    (1) New animal drugs approved for use in animal feed are placed in 
two categories as follows:
    (i) Category I--These drugs require no withdrawal period at the 
lowest use level in each major species for which they are approved or 
are approved for use only in minor species.
    (ii) Category II--These drugs require a withdrawal period at the 
lowest use level for at least one major species for which they are 
approved, or are regulated on a ``no-residue'' basis or with a zero 
tolerance because of carcinogenic concern regardless of whether a 
withdrawal period is required in any species.
    (2) A ``Type A medicated article'' is intended solely for use in the 
manufacture of another Type A medicated article or a Type B or Type C 
medicated feed. It consists of a new animal drug(s), with or without 
carrier (e.g., calcium carbonate, rice hull, corn, gluten) with or 
without inactive ingredients. The manufacture of a Type A medicated 
article requires an application approved under Sec. 514.105 of this 
chapter or an index listing granted under Sec. 516.151 of this chapter.
    (3) A ``Type B medicated feed'' is intended solely for the 
manufacture of other medicated feeds (Type B or Type C). It contains a 
substantial quantity of nutrients including vitamins and/or minerals 
and/or other nutritional ingredients in an amount not less than 25 
percent of the weight. It is manufactured by diluting a Type A medicated 
article or another Type B medicated feed. The maximum concentration of 
animal drug(s) in a Type B medicated feed is 200 times the highest 
continuous use level for Category I drugs and 100 times the highest 
continuous use level for Category II drugs. The term ``highest 
continuous use level'' means the highest dosage at which the drug is 
approved for continuous use (14 days or more), or, if the drug is not 
approved for continuous use, it means the highest level used for disease 
prevention or control. If the drug is approved for multiple species at 
different use levels, the highest approved level of use would govern 
under this definition. The manufacture of a Type B medicated feed from a 
Category II, Type A medicated article requires a medicated feed mill

[[Page 416]]

license application approved under Sec. 515.20 of this chapter.
    (4) A ``Type C medicated feed'' is intended as the complete feed for 
the animal or may be fed ``top dressed'' (added on top of usual ration) 
on or offered ``free-choice'' (e.g., supplement) in conjunction with 
other animal feed. It contains a substantial quantity of nutrients 
including vitamins, minerals, and/or other nutritional ingredients. It 
is manufactured by diluting a Type A medicated article or a Type B 
medicated feed. A Type C medicated feed may be further diluted to 
produce another Type C medicated feed. The manufacture of a Type C 
medicated feed from a Category II, Type A medicated article requires a 
medicated feed mill license application approved under Sec. 515.20 of 
this chapter.
    (5) A Type B or Type C medicated feed manufactured from a drug 
component (bulk or ``drum-run'' (dried crude fermentation product)) 
requires an application approved under Sec. 514.105 of this chapter or 
an index listing granted under Sec. 516.151 of this chapter.
    (6) A ``veterinary feed directive (VFD) drug'' is a drug intended 
for use in or on animal feed which is limited by an approved application 
filed pursuant to section 512(b) of the Federal Food, Drug, and Cosmetic 
Act, a conditionally approved application filed pursuant to section 571 
of the Federal Food, Drug, and Cosmetic Act, or an index listing under 
section 572 of the Federal Food, Drug, and Cosmetic Act to use under the 
professional supervision of a licensed veterinarian. Use of animal feed 
bearing or containing a VFD drug must be authorized by a lawful 
veterinary feed directive.
    (7) A ``veterinary feed directive'' is a written (nonverbal) 
statement issued by a licensed veterinarian in the course of the 
veterinarian's professional practice that orders the use of a VFD drug 
or combination VFD drug in or on an animal feed. This written statement 
authorizes the client (the owner of the animal or animals or other 
caretaker) to obtain and use animal feed bearing or containing a VFD 
drug or combination VFD drug to treat the client's animals only in 
accordance with the conditions for use approved, conditionally approved, 
or indexed by the Food and Drug Administration.
    (8) A ``medicated feed'' means a Type B medicated feed as defined in 
paragraph (b)(3) of this section or a Type C medicated feed as defined 
in paragraph (b)(4) of this section.
    (9) For the purposes of this part, a ``distributor'' means any 
person who distributes a medicated feed containing a VFD drug to another 
person. Such other person may be another distributor or the client-
recipient of a VFD.
    (10) An ``animal production facility'' is a location where animals 
are raised for any purpose, but does not include the specific location 
where medicated feed is made.
    (11) An ``acknowledgment letter'' is a written (nonverbal) 
communication provided to a distributor (consignor) from another 
distributor (consignee). An acknowledgment letter must be provided 
either in hardcopy or through electronic media and must affirm:
    (i) That the distributor will not ship such VFD feed to an animal 
production facility that does not have a VFD,
    (ii) That the distributor will not ship such VFD feed to another 
distributor without receiving a similar written acknowledgment letter, 
and
    (iii) That the distributor has complied with the distributor 
notification requirements of Sec. 558.6(c)(5).
    (12) A ``combination veterinary feed directive (VFD) drug'' is a 
combination new animal drug (as defined in Sec. 514.4(c)(1)(i) of this 
chapter) intended for use in or on animal feed which is limited by an 
approved application filed under section 512(b) of the Federal Food, 
Drug, and Cosmetic Act, a conditionally approved application filed under 
section 571 of the Federal Food, Drug, and Cosmetic Act, or an index 
listing under section 572 of the Federal Food, Drug, and Cosmetic Act to 
use under the professional supervision of a licensed veterinarian, and 
at least one of the new animal drugs in the combination is a VFD drug. 
Use of animal feed bearing or containing a combination VFD drug must be 
authorized by a lawful VFD.
    (13) ``Major species'' means cattle, horses, swine, chickens, 
turkeys, dogs, and cats.

[[Page 417]]

    (14) ``Minor species'' means animals, other than humans, that are 
not major species.

[51 FR 7392, Mar. 3, 1986, as amended at 52 FR 2682, Jan. 26, 1987; 54 
FR 51386, Dec. 15, 1989; 56 FR 19268, Apr. 26, 1991; 64 FR 63206, Nov. 
19, 1999; 65 FR 76929, Dec. 8, 2000; 72 FR 69130, Dec. 6, 2007; 80 FR 
31733, June 3, 2015; 81 FR 57800, Aug. 24, 2016]



Sec. 558.4  Requirement of a medicated feed mill license.

    (a) A feed manufacturing facility must possess a medicated feed mill 
license in order to manufacture a Type B or Type C medicated feed from a 
Category II, Type A medicated article.
    (b) The manufacture of the following types of feed are exempt from 
the required license, unless otherwise specified:
    (1) Type B or Type C medicated feed using Category I, Type A 
medicated articles or Category I, Type B or Type C medicated feeds; and
    (2) Type B or Type C medicated feed using Category II, Type B or 
Type C medicated feeds.
    (c) The use of Type B and Type C medicated feeds shall also conform 
to the conditions of use provided for in subpart B of this part.
    (d) This paragraph identifies each drug by category, the maximum 
level of drug in Type B medicated feeds, and the assay limits for the 
drug in Type A medicated articles and Type B and Type C medicated feeds, 
as follows:

                                                   Category I
----------------------------------------------------------------------------------------------------------------
                                            Assay
                                            limits                                 Assay limits percent \1\ Type
                  Drug                   percent \1\     Type B maximum (200x)                B/C \2\
                                            Type A
----------------------------------------------------------------------------------------------------------------
Amprolium with Ethopabate..............       94-114  22.75 g/lb (5.0%).........  80-120.
Avilamycin.............................       90-110  7.3 g/lb (1.6%)...........  80-110.
Bacitracin methylenedisalicylate.......       85-115  25.0 g/lb (5.5%)..........  70-130.
Bacitracin zinc........................       84-115  5.0 g/lb (1.1%)...........  70-130.
Bambermycins...........................       90-110  800 g/ton (0.09%).........  80-120/70-130.
Chlortetracycline......................       85-115  40.0 g/lb (8.8%)..........  80-115/70-130.
Coumaphos..............................       95-115  6.0 g/lb (1.3%)...........  80-120.
Decoquinate............................       90-105  2.72 g/lb (0.6%)..........  80-120.
Dichlorvos.............................      100-115  33.0 g/lb (7.3%)..........  90-120/80-130.
Diclazuril.............................       90-110  182 g/t (0.02%)...........  85-115/70-120.
Efrotomycin............................       94-113  1.45 g/lb (0.32%).........  80-120.
Iodinated casein.......................       85-115  20.0 g/lb (4.4%)..........  75-125.
Laidlomycin propionate potassium.......       90-110  1 g/lb (0.22%)............  90-115/85-115.
Lasalocid..............................       95-115  40.0 g/lb (8.8%)..........  Type B (cattle and sheep): 80-
                                                                                   120; Type C (all): 75-125.
Lincomycin.............................       90-115  20.0 g/lb (4.4%)..........  80-130.
Lubabegron.............................       87-107  908 g/ton.................  85-115/80-120.
Melengestrol acetate...................       90-110  10.0 g/ton (0.0011%)......  70-120.
Monensin...............................       85-115  40.0 g/lb (8.8%)..........  Chickens, turkeys, and quail:
                                                                                   75-125; Cattle: 5-10 g/ton 80-
                                                                                   120; Cattle: 10-30 g/ton 85-
                                                                                   115; Goats: 20 g/ton 85-115;
                                                                                   Liq. feed: 80-120.
Narasin................................       90-110  9.0 g/lb (1.98%)..........  85-115/75-125.
Nicarbazin (granular)..................       90-110  9.0 g/lb (1.98%)..........  85-115/75-125.
 Narasin...............................       90-110  9.0 g/lb (1.98%)..........  85-115/75-125.
Nystatin...............................       85-125  5.0 g/lb (1.1%)...........  75-125.
Oxytetracycline........................       90-120  20.0 g/lb (4.4%)..........  75-125/65-135.
Poloxalene.............................       90-110  54.48 g/lb (12.0%)........  Liq. feed: 85-115.
Ractopamine............................       85-105  2.46 g/lb (0.54%).........  80-110/75-125.
Salinomycin............................       90-110  6.0 g/lb (1.3%)...........  80-120.
Semduramicin (as semduramicin sodium)..       90-110  2.27 g/lb (0.50%).........  80-110
Semduramicin (as semduramicin sodium          90-110  2.27 g/lb (0.50%).........  80-120
 biomass).
Tylosin................................       80-120  10.0 g/lb (2.2%)..........  75-125.
Tylvalosin.............................       90-110  3.86 g/lb.................  85-115.
Virginiamycin..........................       85-115  10.0 g/lb (2.2%)..........  70-130.
Zoalene................................       92-104  11.35 g/lb (2.5%).........  85-115.
----------------------------------------------------------------------------------------------------------------
\1\ Percent of labeled amount.
\2\ Values given represent ranges for either Type B or Type C medicated feeds. For those drugs that have two
  range limits, the first set is for a Type B medicated feed and the second set is for a Type C medicated feed.
  These values (ranges) have been assigned in order to provide for the possibility of dilution of a Type B
  medicated feed with lower assay limits to make Type C medicated feed.


[[Page 418]]


                                                   Category II
----------------------------------------------------------------------------------------------------------------
                                            Assay
                                            limits                                 Assay limits percent \1\ Type
                  Drug                   percent \1\     Type B maximum (100x)                B/C \2\
                                            Type A
----------------------------------------------------------------------------------------------------------------
Amprolium..............................       94-114  11.35 g/lb (2.5%).........  80-120.
Apramycin..............................       88-112  7.5 g/lb (1.65%)..........  80-120.
Carbadox...............................       90-110  2.5 g/lb (0.55%)..........  75-125.
Clopidol...............................       94-106  11.4 g/lb (2.5%)..........  90-115/80-120.
Erythromycin...........................       85-115  4.625 g/lb (1.02%)........  75-125.
Famphur................................      100-110  5.5 g/lb (1.21%)..........  90-115/80-120.
Fenbendazole...........................       93-113  8.87 g/lb (1.96%).........  75-125.
Florfenicol............................       90-110  9.1 g/lb (2.0%)...........  Swine feed: 85-115
                                                                                  Catfish feed: 80-110.
                                                                                  Salmonid feed: 80-110.
Halofuginone hydrobromide..............       90-115  272.0 g/ton (.03%)........  75-125.
Hygromycin B...........................       90-110  1,200 g/ton (0.13%).......  75-125.
Ivermectin.............................       95-105  1,180 g/ton (0.13%).......  80-110.
Maduramicin ammonium...................       90-110  545 g/ton (.06%)..........  80-120.
Morantel tartrate......................       90-110  66.0 g/lb (14.52%)........  85-115.
Neomycin...............................       80-120  20 g/lb (4.4%)............  70-125.
Oxytetracycline........................       80-120  20 g/lb (4.4%)............  65-135.
  Neomycin sulfate.....................       80-120  100 g/lb (22.0%)..........  70-125.
Nicarbazin (granular)..................       90-110  5.675 g/lb (1.25%)........  85-115/75-125.
Nicarbazin (powder)....................       96-104  9.08 g/lb (2.00%).........  85-115/75-125.
Novobiocin.............................       85-115  17.5 g/lb (3.85%).........  80-120.
Pyrantel tartrate......................       90-110  36 g/lb (7.9%)............  75-125.
Robenidine.............................       95-115  1.5 g/lb (0.33%)..........  80-120.
Sulfadimethoxine.......................       90-110  Poultry: 5.675 g/lb.......  80-115/75-125.
                                                      Fish: 85.1 g/lb...........
  Ormetoprim...........................       90-110  Poultry: 3.405 g/lb.......  80-115.
                                                      Fish: 17.0 g/lb...........
Sulfamerazine..........................       85-115  18.6 g/lb (4.0%)..........  85-115.
Sulfamethazine.........................       85-115  10.0 g/lb (2.2%)..........  80-120.
  Chlortetracycline....................       85-115  10.0 g/lb (2.2%)..........  85-125/70-130.
Sulfamethazine.........................       85-115  10.0 g/lb (2.2%)..........  80-120.
  Tylosin..............................       80-120  10.0 g/lb (2.2%)..........  75-125.
Sulfaquinoxaline.......................       98-106  11.2 g/lb (2.5%)..........  85-115.
Thiabendazole..........................       94-106  45.4 g/lb (10.0%).........  7% 85-115; <7% 90-
                                                                                   110.
Tiamulin hydrogen fumarate.............       90-115  10 g/lb...................  90-115/70-130.
Tilmicosin.............................       90-110  37.9 g/lb (8.35%).........  Swine Type B/C feed: 85-115.
                                                                                  Cattle Type B feed: 85-115.
                                                                                  Cattle Type C feed: 80-110.
Zilpaterol.............................       90-110  680 g/t (0.075%)..........  80-110/75-115.
----------------------------------------------------------------------------------------------------------------
\1\ Percent of labeled amount.
\2\ Values given represent ranges for either Type B or Type C medicated feeds. For those drugs that have two
  range limit, the first set is for a Type B medicated feed and the second set is for a Type C medicated feed.
  These values (ranges) have been assigned in order to provide for the possibility of dilution of a Type B
  medicated feed with lower assay limits to make a Type C medicated feed.

    (e) When drugs from both categories are in combination, the Category 
II requirements will apply to the combination drug product.

[51 FR 7392, Mar. 3, 1986]

    Editorial Note: For Federal Register citations affecting Sec. 
558.4, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and at www.govinfo.gov.



Sec. 558.5  Requirements for liquid medicated feed.

    (a) What types of liquid medicated feeds are covered by this 
section? This section covers the following types of liquid medicated 
feed:
    (1) Type B feed that is intended for further manufacture of other 
medicated feeds (Sec. 558.3(b)(3)) or:
    (2) Type C feed that is intended for the following:
    (i) Further manufacture of another Type C feed, or
    (ii) Top-dressing (adding on top of the usual ration) (Sec. 
558.3(b)(4)).
    (b) How is liquid free-choice medicated feed regulated? Liquid free-
choice medicated feed is covered by this section and by Sec. 510.455.
    (c) What is required for new animal drugs intended for use in liquid 
feed? Any new animal drug intended for use in liquid feed must be 
approved for such use under section 512 of the Federal

[[Page 419]]

Food, Drug, and Cosmetic Act (the act) or index listed under section 572 
of the act. Such approvals under section 512 of the act must be:
    (1) An original NADA,
    (2) A supplemental NADA, or
    (3) An abbreviated NADA.
    (d) What are the approval requirements under section 512 of the act 
for new animal drugs intended for use in liquid feed? An approval under 
section 512 of the act for a new animal drug intended for use in liquid 
feed must contain the following information:
    (1) Data, or a reference to data in a master file (MF), that shows 
the relevant ranges of conditions under which the drug will be 
chemically stable in liquid feed under field use conditions; and
    (2) Data, or a reference to data in an MF, that shows that the drug 
is physically stable in liquid feed under field conditions; or
    (3) Feed labeling with recirculation or agitation directions as 
follows:
    (i) For liquid feeds stored in recirculating tank systems: 
Recirculate immediately prior to use for not less than 10 minutes, 
moving not less than 1 percent of the tank contents per minute from the 
bottom of the tank to the top. Recirculate daily as described even when 
not used.
    (ii) For liquid feeds stored in mechanical, air, or other agitation-
type tank systems: Agitate immediately prior to use for not less than 10 
minutes, creating a turbulence at the bottom of the tank that is visible 
at the top. Agitate daily as described even when not used.
    (e) How are chemical and physical stability data to be submitted? 
The data must be submitted as follows:
    (1) Directly in the NADA,
    (2) By a sponsor, or
    (3) To an MF that a sponsor may then reference in its NADA with 
written consent of the MF holder.
    (f) What will be stated in the published approval for a new animal 
drug intended for use in liquid feed? The approval of a new animal drug 
intended for use in liquid feed as published in this subchapter will 
include the following requirements:
    (1) The formula and/or specifications of the liquid medicated feed, 
where the owner of this information requests such publication; and/or
    (2) A statement that the approval has been granted for a proprietary 
formula and/or specifications.
    (g) When is a medicated feed mill license required for the 
manufacture of a liquid medicated feed? An approved medicated feed mill 
license is required for the manufacture of the following types of feeds:
    (1) All liquid medicated feeds that contain a Category II drug, and
    (2) Liquid medicated feeds that contain a Category I drug and use a 
proprietary formula and/or specifications.
    (h) What measures are in place to prevent certain drugs, approved 
for use in animal feed or drinking water but not in liquid medicated 
feed, from being diverted to use in liquid feeds? Any product containing 
any form of bacitracin, oxytetracycline, or chlortetracycline, intended 
for oral administration via animal feed and/or drinking water, and not 
approved for use in a liquid medicated feed must include in its labeling 
the following statement: ``FOR USE IN ___ ONLY. NOT FOR USE IN LIQUID 
MEDICATED FEEDS.'' The blank may be filled in with the words: ``DRY 
FEEDS'', ``DRINKING WATER'', or ``DRY FEEDS AND DRINKING WATER''.
    (i) Can the labeling provisions of paragraph (h) of this section be 
waived, and how can I apply for a waiver? (1) The labeling provisions of 
paragraph (h) of this section may be waived if there is evidence to 
indicate that it is unlikely a new animal drug would be used in the 
manufacture of a liquid medicated feed.
    (2) To obtain a waiver, you must submit a letter requesting a waiver 
to the Office of New Animal Drug Evaluation (HFV-100), Center for 
Veterinary Medicine, Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855.
    (3) The letter must include a copy of the product label; a 
description of the formulation; and information to establish that the 
physical, chemical, or other properties of the new animal drug are such 
that diversion to use in liquid medicated feed is unlikely.
    (j) What else do I need to know about the labeling provisions of 
paragraph (h) of this section? The labeling provisions of

[[Page 420]]

paragraph (h) of this section may be implemented without prior approval 
as provided for in Sec. 514.8(c)(3) of this chapter.

[69 FR 30197, May 27, 2004, as amended at 71 FR 74785, Dec. 13, 2006; 72 
FR 69131, Dec. 6, 2007]



Sec. 558.6  Veterinary feed directive drugs.

    (a) General requirements related to veterinary feed directive (VFD) 
drugs. (1) Animal feed bearing or containing a VFD drug or a combination 
VFD drug (a VFD feed or combination VFD feed) may be fed to animals only 
by or upon a lawful VFD issued by a licensed veterinarian.
    (2) A VFD feed or combination VFD feed must not be fed to animals 
after the expiration date on the VFD.
    (3) Use and labeling of a VFD drug or a combination VFD drug in feed 
is limited to the approved, conditionally approved, or indexed 
conditions of use. Use of feed containing this veterinary feed directive 
(VFD) drug in a manner other than as directed on the labeling 
(extralabel use) is not permitted.
    (4) All involved parties (the veterinarian, the distributor, and the 
client) must retain a copy of the VFD for 2 years. The veterinarian must 
retain the original VFD in its original form (electronic or hardcopy). 
The distributor and client copies may be kept as an electronic copy or 
hardcopy.
    (5) All involved parties must make the VFD and any other records 
specified in this section available for inspection and copying by FDA 
upon request.
    (6) All labeling and advertising for VFD drugs, combination VFD 
drugs, and feeds containing VFD drugs or combination VFD drugs must 
prominently and conspicuously display the following cautionary 
statement: ``Caution: Federal law restricts medicated feed containing 
this veterinary feed directive (VFD) drug to use by or on the order of a 
licensed veterinarian.''
    (b) Responsibilities of the veterinarian issuing the VFD. (1) In 
order for a VFD to be lawful, the veterinarian issuing the VFD must:
    (i) Be licensed to practice veterinary medicine; and
    (ii) Be operating in the course of the veterinarian's professional 
practice and in compliance with all applicable veterinary licensing and 
practice requirements, including issuing the VFD in the context of a 
veterinarian-client-patient relationship (VCPR) as defined by the State. 
If applicable VCPR requirements as defined by such State do not include 
the key elements of a valid VCPR as defined in Sec. 530.3(i) of this 
chapter, the veterinarian must issue the VFD in the context of a valid 
VCPR as defined in Sec. 530.3(i) of this chapter.
    (2) The veterinarian must only issue a VFD that is in compliance 
with the conditions for use approved, conditionally approved, or indexed 
for the VFD drug or combination VFD drug.
    (3) The veterinarian must ensure that the following information is 
fully and accurately included on the VFD:
    (i) The veterinarian's name, address, and telephone number;
    (ii) The client's name, business or home address, and telephone 
number;
    (iii) The premises at which the animals specified in the VFD are 
located;
    (iv) The date of VFD issuance;
    (v) The expiration date of the VFD. This date must not extend beyond 
the expiration date specified in the approval, conditional approval, or 
index listing, if such date is specified. In cases where the expiration 
date is not specified in the approval, conditional approval, or index 
listing, the expiration date of the VFD must not exceed 6 months after 
the date of issuance;
    (vi) The name of the VFD drug(s);
    (vii) The species and production class of animals to be fed the VFD 
feed;
    (viii) The approximate number of animals to be fed the VFD feed by 
the expiration date of the VFD. The approximate number of animals is the 
potential number of animals of the species and production class 
identified on the VFD that will be fed the VFD feed or combination VFD 
feed at the specified premises by the expiration date of the VFD;
    (ix) The indication for which the VFD is issued;
    (x) The level of VFD drug in the VFD feed and duration of use;
    (xi) The withdrawal time, special instructions, and cautionary 
statements necessary for use of the drug in conformance with the 
approval;

[[Page 421]]

    (xii) The number of reorders (refills) authorized, if permitted by 
the drug approval, conditional approval, or index listing. In cases 
where reorders (refills) are not specified on the labeling for an 
approved, conditionally approved, or index listed VFD drug, reorders 
(refills) are not permitted;
    (xiii) The statement: ``Use of feed containing this veterinary feed 
directive (VFD) drug in a manner other than as directed on the labeling 
(extralabel use) is not permitted.'';
    (xiv) An affirmation of intent for combination VFD drugs as 
described in paragraph (6) of this section; and
    (xv) The veterinarian's electronic or written signature.
    (4) The veterinarian may, at his or her discretion, enter the 
following information on the VFD to more specifically identify the 
animals authorized to be treated/fed the VFD feed:
    (i) A more specific description of the location of animals (e.g., by 
site, pen, barn, stall, tank, or other descriptor that the veterinarian 
deems appropriate);
    (ii) The approximate age range of the animals;
    (iii) The approximate weight range of the animals; and
    (iv) Any other information the veterinarian deems appropriate to 
identify the animals specified in the VFD.
    (5) For VFDs intended to authorize the use of an approved, 
conditionally approved, or indexed combination VFD drug that includes 
more than one VFD drug, the veterinarian must include the drug-specific 
information required in paragraphs (b)(3)(vi), (ix), (x), and (xi) of 
this section for each VFD drug in the combination.
    (6) The veterinarian may restrict VFD authorization to only include 
the VFD drug(s) cited on the VFD or may expand such authorization to 
allow the use of the cited VFD drug(s) along with one or more over-the-
counter (OTC) animal drugs in an approved, conditionally approved, or 
indexed combination VFD drug. The veterinarian must affirm his or her 
intent regarding combination VFD drugs by including one of the following 
statements on the VFD:
    (i) ``This VFD only authorizes the use of the VFD drug(s) cited in 
this order and is not intended to authorize the use of such drug(s) in 
combination with any other animal drugs.''
    (ii) ``This VFD authorizes the use of the VFD drug(s) cited in this 
order in the following FDA-approved, conditionally approved, or indexed 
combination(s) in medicated feed that contains the VFD drug(s) as a 
component.'' [List specific approved, conditionally approved, or indexed 
combination medicated feeds following this statement.]
    (iii) ``This VFD authorizes the use of the VFD drug(s) cited in this 
order in any FDA-approved, conditionally approved, or indexed 
combination(s) in medicated feed that contains the VFD drug(s) as a 
component.''
    (7) The veterinarian must issue a written (nonverbal) VFD.
    (8) The veterinarian must send a copy of the VFD to the distributor 
via hardcopy, facsimile (fax), or electronically. If in hardcopy, the 
veterinarian must send the copy of the VFD to the distributor either 
directly or through the client.
    (9) The veterinarian must provide a copy of the VFD to the client.
    (c) Responsibilities of any person who distributes an animal feed 
containing a VFD drug or a combination VFD drug. (1) The distributor is 
permitted to fill a VFD only if the VFD contains all the information 
required in paragraph (b)(3) of this section.
    (2) The distributor is permitted to distribute an animal feed 
containing a VFD drug or combination VFD drug only if it complies with 
the terms of the VFD and is manufactured and labeled in conformity with 
the approved, conditionally approved, or indexed conditions of use for 
such drug.
    (3) The distributor must keep records of the receipt and 
distribution of all medicated animal feed containing a VFD drug for 2 
years.
    (4) In addition to other applicable recordkeeping requirements found 
in this section, if the distributor manufactures the animal feed bearing 
or containing the VFD drug, the distributor must also keep VFD feed 
manufacturing records for 1 year in accordance with part 225 of this 
chapter. Such records must be made available for inspection and copying 
by FDA upon request.

[[Page 422]]

    (5) A distributor of animal feed containing a VFD drug must notify 
FDA prior to the first time it distributes animal feed containing a VFD 
drug. The notification is required one time per distributor and must 
include the following information:
    (i) The distributor's complete name and business address;
    (ii) The distributor's signature or the signature of the 
distributor's authorized agent; and
    (iii) The date the notification was signed.
    (6) A distributor must also notify FDA within 30 days of any change 
in ownership, business name, or business address.
    (7) The notifications cited in paragraphs (c)(5) and (6) of this 
section must be submitted to the Food and Drug Administration, Center 
for Veterinary Medicine, Division of Animal Feeds (HFV-220), 12225 
Wilkins Ave., Rockville, MD 20852, Fax: 240-453-6882, or email (via 
attachment): [email protected].
    (8) A distributor is permitted to distribute a VFD feed to another 
distributor only if the originating distributor (consignor) first 
obtains a written (nonverbal) acknowledgment letter, as defined in Sec. 
558.3(b)(11), from the receiving distributor (consignee) before the feed 
is shipped. Consignor distributors must retain a copy of each consignee 
distributor's acknowledgment letter for 2 years.

[80 FR 31733, June 3, 2015; 80 FR 35841, June 23, 2015, as amended at 85 
FR 50784, Aug. 18, 2020]



       Subpart B_Specific New Animal Drugs for Use in Animal Feeds



Sec. 558.55  Amprolium.

    (a) Specifications. Type A medicated article containing 25 percent 
amprolium.
    (b) Sponsor. No. 016592 in Sec. 510.600(c) of this chapter.
    (c) Related tolerances. See Sec. 556.50 of this chapter.
    (d) Special considerations. Do not use in Type B or Type C medicated 
feeds containing bentonite.
    (e) Conditions of use--(1) Cattle. It is used as follows:

----------------------------------------------------------------------------------------------------------------
      Amprolium in grams per ton              Indications for use                Limitations            Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 113.5 to 11, 350; to provide 5      Calves: As an aid in the        Top-dress on or mix in the        016592
 milligrams per kilogram of body         prevention of coccidiosis       daily ration. Feed for 21
 weight per day.                         caused by Eimeria bovis and     days when experience
                                         E. zuernii.                     indicates that coccidiosis
                                                                         is likely to be a hazard, as
                                                                         the sole source of
                                                                         amprolium. Withdraw 24 hours
                                                                         before slaughter. A
                                                                         withdrawal period has not
                                                                         been established for this
                                                                         product in preruminating
                                                                         calves. Do not use in calves
                                                                         to be processed for veal.
(ii) 113.5 to 11, 350; to provide 10    Calves: As an aid in the        Top-dress on or mix in the        016592
 milligrams per kilogram of body         treatment of coccidiosis        daily ration. Feed for 5
 weight per day.                         caused by Eimeria bovis and     days as the sole source of
                                         E. zuernii.                     amprolium. Withdraw 24 hours
                                                                         before slaughter. A
                                                                         withdrawal period has not
                                                                         been established for this
                                                                         product in preruminating
                                                                         calves. Do not use in calves
                                                                         to be processed for veal.
----------------------------------------------------------------------------------------------------------------

    (2) Chickens. It is used as follows:

----------------------------------------------------------------------------------------------------------------
                                     Combination in grams
    Amprolium in grams per ton             per ton          Indications for use       Limitations       Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 36.3 to 113.5.................  .....................  Replacement           Feed continuously        016592
                                                            chickens: For         until onset of
                                                            development of        production as
                                                            active immunity to    follows:
                                                            coccidiosis.
----------------------------------------------------------------------------------------------------------------


[[Page 423]]


----------------------------------------------------------------------------------------------------------------
                                                Up to 5 weeks of age  From 5 to 8 weeks of   Over 8 weeks of age
                                               ----------------------          age         ---------------------
              Growing conditions                                     ----------------------
                                                 Amprolium in grams    Amprolium in grams    Amprolium in grams
                                                       per ton               per ton               per ton
----------------------------------------------------------------------------------------------------------------
Severe exposure to coccidiosis................                 113.5            72.6-113.5            36.3-113.5
                                                           (0.0125%)      (0.008%-0.0125%)      (0.004%-0.0125%)
Moderate exposure to coccidiosis..............            72.6-113.5            54.5-113.5            36.3-113.5
                                                    (0.008%-0.0125%)      (0.006%-0.0125%)      (0.004%-0.0125%)
Slight exposure to coccidiosis................            36.3-113.5            36.3-113.5            36.3-113.5
                                                    (0.004%-0.0125%)      (0.004%-0.0125%)      (0.004%-0.0125%)
----------------------------------------------------------------------------------------------------------------


----------------------------------------------------------------------------------------------------------------
                                     Combination in grams
    Amprolium in grams per ton             per ton          Indications for use       Limitations       Sponsor
----------------------------------------------------------------------------------------------------------------
(ii) 36.3 to 113.5................  Bacitracin             Replacement           Feed according to        054771
                                     methylenedisalicylat   chickens: For         subtable in item
                                     e 4 to 50.             development of        (i). Bacitracin
                                                            active immunity to    methylenedisalicyla
                                                            coccidiosis; and      te as provided by
                                                            for increased rate    No. 054771 in Sec.
                                                            of weight gain and     510.600(c) of this
                                                            improved feed         chapter.
                                                            efficiency.
(iii) 72.6 to 113.5...............  .....................  Broiler chickens:     Feed continuously as     016592
                                                            For prevention of     the sole ration; as
                                                            coccidiosis caused    sole source of
                                                            by Eimeria tenella    amprolium.
                                                            only.
(iv) 72.6 to 113.5................  Bambermycins 1 to 2..  Broiler chickens:     Feed continuously as     016592
                                                            For prevention of     the sole ration; as
                                                            coccidiosis caused    sole source of
                                                            by Eimeria tenella    amprolium.
                                                            only; and for         Bambermycins as
                                                            increased rate of     provided by No.
                                                            weight gain and       016592 in Sec.
                                                            improved feed         510.600(c) of this
                                                            efficiency.           chapter.
(v) 113.5.........................  .....................  1. Laying chickens:   Feed continuously as     016592
                                                            For prevention of     the sole ration; as
                                                            coccidiosis.          the sole source of
                                                                                  amprolium.
                                                           2. Laying chickens:   Feed for 2 weeks....
                                                            For treatment of
                                                            coccidiosis in
                                                            moderate outbreaks.
(vi) 113.5 to 227.................  .....................  1. Replacement        Feed continuously        016592
                                                            chickens: For         from day-old until
                                                            prevention of         onset of
                                                            coccidiosis where     production; as the
                                                            immunity to           sole source of
                                                            coccidiosis is not    amprolium.
                                                            desired.
                                                           2. Broiler chickens:  Feed continuously as
                                                            For prevention of     the sole ration; as
                                                            coccidiosis where     sole source of
                                                            immunity to           amprolium.
                                                            coccidiosis is not
                                                            desired.
(vii) 113.5 to 227................  Bambermycins 1 to 2..  Broiler chickens:     Feed continuously as     016592
                                                            For prevention of     the sole ration; as
                                                            coccidiosis where     sole source of
                                                            immunity to           amprolium.
                                                            coccidiosis is not    Bambermycins as
                                                            desired; and for      provided by No.
                                                            increased rate of     016592 in Sec.
                                                            weight gain and       510.600(c) of this
                                                            improved feed         chapter.
                                                            efficiency.
(viii) 227........................  .....................  Laying chickens: For  Feed for 2 weeks....     016592
                                                            treatment of
                                                            coccidiosis in
                                                            severe outbreaks..
----------------------------------------------------------------------------------------------------------------

    (3) Turkeys. It is used as follows:

----------------------------------------------------------------------------------------------------------------
                                     Combination in grams
    Amprolium in grams per ton             per ton          Indications for use       Limitations       Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 113.5.........................  Bambermycins 1 to 4..  Growing turkeys: For  Feed continuously as     016592
                                                            prevention of         the sole source of
                                                            coccidiosis; and      amprolium;
                                                            for increased rate    bambermycins as
                                                            of weight gain and    provided by No.
                                                            improved feed         016592 in Sec.
                                                            efficiency.           510.600(c) of this
                                                                                  chapter.
(ii) 113.5 to 227.................  .....................  Turkeys: For          Feed continuously as     016592
                                                            prevention of         the sole ration; as
                                                            coccidiosis.          sole source of
                                                                                  amprolium.
----------------------------------------------------------------------------------------------------------------

    (4) Pheasants. It is used as follows:

[[Page 424]]



----------------------------------------------------------------------------------------------------------------
                                     Combination in grams
    Amprolium in grams per ton             per ton          Indications for use       Limitations       Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 159...........................  .....................  Growing pheasants:    Feed continuously as     016592
                                                            For the prevention    sole ration. Use as
                                                            of coccidiosis        sole source of
                                                            caused by Eimeria     amprolium.
                                                            colchici, E.
                                                            duodenalis, and E.
                                                            phasiani.
(ii) [Reserved]
----------------------------------------------------------------------------------------------------------------

    (5) Permitted combinations. Amprolium may also be used in 
combination with:
    (i) Virginiamycin as in Sec. 558.635.
    (ii) [Reserved]

[41 FR 10985, Mar. 15, 1976]

    Editorial Note: For Federal Register citations affecting Sec. 
558.55, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and at www.govinfo.gov.



Sec. 558.58  Amprolium and ethopabate.

    (a) Specifications. Type A medicated articles containing:
    (1) 25 percent amprolium and 8 percent ethopabate or 5 percent 
amprolium and 1.6 percent ethopabate;
    (2) 25 percent amprolium and 0.8 percent ethopabate or 5 percent 
amprolium and 0.16 percent ethopabate.
    (b) Sponsor. See No. 016592 in Sec. 510.600(c) of this chapter.
    (c) Related tolerances. See Sec. Sec. 556.50 and 556.260 of this 
chapter.
    (d) Special considerations. Do not use in Type B or Type C medicated 
feeds containing bentonite.
    (e) Conditions of use. It is used in chicken feed as follows:

----------------------------------------------------------------------------------------------------------------
 Amprolium and ethopabate in grams   Combination in grams
              per ton                      per ton          Indications for use       Limitations       Sponsor
----------------------------------------------------------------------------------------------------------------
(1) Amprolium 113.5 and ethopabate  .....................  Broiler chickens: As  Feed continuously as     016592
 3.6.                                                       an aid in the         sole ration; as
                                                            prevention of         sole source of
                                                            coccidiosis.          amprolium. Not for
                                                                                  laying chickens.
(2) Amprolium 113.5 and ethopabate  .....................  Broiler chickens and  Feed continuously as     016592
 36.3.                                                      replacement           sole ration; as
                                                            chickens: where       sole source of
                                                            immunity to           amprolium. Not for
                                                            coccidiosis is not    chickens over 16
                                                            desired: As an aid    weeks of age.
                                                            in the prevention
                                                            of coccidiosis
                                                            where severe
                                                            exposure to
                                                            coccidiosis from
                                                            Eimeria acervulina,
                                                            E. maxima, and E.
                                                            brunetti is likely
                                                            to occur.
(3) Amprolium 113.5 and ethopabate  Bacitracin 4 to 50...  1. Broiler chickens   Feed as the sole         016592
 36.3.                                                      and replacement       ration from the
                                                            chickens: where       time chickens are
                                                            immunity to           placed on litter
                                                            coccidiosis is not    until past the time
                                                            desired; to aid in    when coccidiosis is
                                                            prevention of         ordinarily a
                                                            coccidiosis where     hazard. Not for
                                                            severe exposure to    chickens over 16
                                                            coccidiosis from      weeks of age; do
                                                            Eimeria acervulina,   not feed to laying
                                                            E. maxima, and E.     chickens; as sole
                                                            brunetti is likely    source of
                                                            to occur; for         amprolium; not for
                                                            increased rate of     use as a treatment
                                                            weight gain in        for outbreaks of
                                                            broiler chickens      coccidiosis.
                                                            raised in floor       Bacitracin as
                                                            pens.                 bacitracin
                                                                                  methylenedisalicyla
                                                                                  te as provided by
                                                                                  No. 054771 in Sec.
                                                                                   510.600(c) of this
                                                                                  chapter.
(4) Amprolium 113.5 and ethopabate  Bacitracin 4 to 50...  2. Broiler chickens:  Feed as the sole         054771
 36.3.                                                      As an aid in          ration from the
                                                            prevention of         time chickens are
                                                            coccidiosis where     placed on litter
                                                            severe exposure to    until market
                                                            coccidiosis from      weight. Not for
                                                            Eimeria acervulina,   chickens over 16
                                                            E. maxima, and E.     weeks of age; do
                                                            brunetti is likely    not feed to laying
                                                            to occur; for         chickens; as sole
                                                            improved feed         source of
                                                            efficiency.           amprolium; not for
                                                                                  use as a treatment
                                                                                  for coccidiosis.
                                                                                  Bacitracin zinc as
                                                                                  provided by No.
                                                                                  054771 in Sec.
                                                                                  510.600(c) of this
                                                                                  chapter.

[[Page 425]]

 
(5) Amprolium 113.5 and ethopabate  Bambermycins 1 to 3..  Broiler chickens: As  Feed continuously as     016592
 36.6.                                                      an aid in the         the sole ration; as
                                                            prevention of         sole source of
                                                            coccidiosis where     amprolium.
                                                            severe exposure to   Bambermycins as
                                                            coccidiosis from      provided by No.
                                                            Eimeria acervulina,   016592 in Sec.
                                                            E. maxima, and E.     510.600(c) of this
                                                            brunetti is likely    chapter.
                                                            to occur; for
                                                            increased rate of
                                                            weight gain,
                                                            improved feed
                                                            efficiency.
(6) Amprolium 227 and ethopabate    .....................  For broiler chickens  Not for laying           016592
 3.6.                                                       and replacement       chickens.
                                                            chickens where
                                                            immunity to
                                                            coccidiosis is not
                                                            desired; prevention
                                                            of coccidiosis.
----------------------------------------------------------------------------------------------------------------

    (f) Amprolium and ethopabate may also be used in combination with:
    (1)-(2) [Reserved]
    (3) Chlortetracycline as in Sec. 558.128.

[41 FR 10990, Mar. 15, 1976]

    Editorial Note: For Federal Register citations affecting Sec. 
558.58, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and at www.govinfo.gov.



Sec. 558.59  Apramycin.

    (a) Specifications. Type A articles containing 75 grams apramycin 
(as apramycin sulfate) per pound.
    (b) Sponsor. See No. 058198 in Sec. 510.600(c) of this chapter.
    (c) Related tolerances. See Sec. 556.52 of this chapter.
    (d) Conditions of use in swine--

----------------------------------------------------------------------------------------------------------------
                                   Combination in
       Apramycin grams/ton            grams/ton       Indications for use           Limitations         Sponsor
----------------------------------------------------------------------------------------------------------------
(1) 150..........................  ..............  For control of porcine    Feed as the sole ration      058198
                                                    colibacillosis            for 14 consecutive
                                                    (weanling pig scours)     days. Withdraw 28 days
                                                    caused by susceptible     before slaughter.
                                                    strains of Escherichia
                                                    coli.
(2) [Reserved]...................
----------------------------------------------------------------------------------------------------------------


[81 FR 94995, Dec. 27, 2016]



Sec. 558.68  Avilamycin.

    (a) Specifications. Each pound of Type A medicated article contains 
45.4 or 90.7 grams of avilamycin.
    (b) Sponsor. See No. 058198 in Sec. 510.600(c) of this chapter.
    (c) Related tolerances. See Sec. 556.60 of this chapter.
    (d) Special considerations. (1) Federal law restricts medicated feed 
containing this veterinary feed directive (VFD) drug to use by or on the 
order of a licensed veterinarian. See Sec. 558.6 for additional 
requirements.
    (2) The expiration date of VFDs for avilamycin medicated feeds must 
not exceed 90 days from the date of issuance. VFDs for avilamycin shall 
not be refilled.
    (e) Conditions of use. Administer in feed as follows:
    (1) Chickens--

----------------------------------------------------------------------------------------------------------------
                                    Combination in
      Avilamycin in grams/ton          grams/ton     Indications for use        Limitations           Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 13.6 to 40.9..................  ..............  Broiler chickens: For  Feed as the sole               058198
                                                     the prevention of      ration for 21
                                                     mortality caused by    consecutive days. To
                                                     necrotic enteritis     assure responsible
                                                     associated with        antimicrobial drug
                                                     Clostridium            use in broiler
                                                     perfringens in         chickens, treatment
                                                     broiler chickens.      administration must
                                                                            begin on or before
                                                                            18 days of age.

[[Page 426]]

 
(ii) 13.6 to 40.9.................    Monensin, 90  Broiler chickens: For  Feed as the sole               058198
                                            to 110   the prevention of      ration for 21
                                                     mortality caused by    consecutive days. To
                                                     necrotic enteritis     assure responsible
                                                     associated with        antimicrobial drug
                                                     Clostridium            use in broiler
                                                     perfringens; and as    chickens, treatment
                                                     an aid in the          administration must
                                                     prevention of          begin on or before
                                                     coccidiosis caused     18 days of age. See
                                                     by Eimeria necatrix,   Sec. 558.355(d) of
                                                     E. tenella, E.         this chapter.
                                                     acervulina, E.         Monensin as provided
                                                     brunetti, E. mivati,   by No. 058198 in
                                                     and E. maxima..        Sec. 510.600(c) of
                                                                            this chapter..
(iii) 13.6 to 40.9................  Narasin, 54 to  Broiler chickens: For  Feed as the sole               058198
                                                90   the prevention of      ration for 21
                                                     mortality caused by    consecutive days to
                                                     necrotic enteritis     chickens that are at
                                                     associated with        risk of developing,
                                                     Clostridium            but not yet showing
                                                     perfringens; and for   clinical signs of,
                                                     the prevention of      necrotic enteritis
                                                     coccidiosis caused     associated with
                                                     by Eimeria necatrix,   Clostridium
                                                     E. tenella, E.         perfringens. To
                                                     acervulina, E.         assure responsible
                                                     brunetti, E. mivati,   antimicrobial drug
                                                     and E. maxima..        use in broiler
                                                                            chickens, treatment
                                                                            administration must
                                                                            begin on or before
                                                                            18 days of age. Do
                                                                            not allow adult
                                                                            turkeys, horses, or
                                                                            other equines access
                                                                            to narasin
                                                                            formulations.
                                                                            Ingestion of narasin
                                                                            by these species has
                                                                            been fatal. Narasin
                                                                            as provided by No.
                                                                            058198 in Sec.
                                                                            510.600(c) of this
                                                                            chapter..
(iv) 13.6 to 40.9.................  Narasin, 27 to  Broiler chickens: For  Feed as the sole               058198
                                           45 plus   the prevention of      ration for 21
                                    nicarbazin, 27   mortality caused by    consecutive days to
                                             to 45   necrotic enteritis     chickens that are at
                                                     associated with        risk of developing,
                                                     Clostridium            but not yet showing
                                                     perfringens; and for   clinical signs of,
                                                     the prevention of      necrotic enteritis
                                                     coccidiosis caused     associated with
                                                     by Eimeria necatrix,   Clostridium
                                                     E. tenella, E.         perfringens.
                                                     acervulina, E.         Avilamycin has not
                                                     brunetti, E. mivati,   been demonstrated to
                                                     and E. maxima.         be effective in
                                                                            broiler chickens
                                                                            showing clinical
                                                                            signs of necrotic
                                                                            enteritis prior to
                                                                            the start of
                                                                            medication. To
                                                                            assure responsible
                                                                            antimicrobial drug
                                                                            use in broiler
                                                                            chickens, treatment
                                                                            administration must
                                                                            begin on or before
                                                                            18 days of age. The
                                                                            safety of avilamycin
                                                                            has not been
                                                                            established in
                                                                            chickens intended
                                                                            for breeding
                                                                            purposes. Do not
                                                                            allow adult turkeys,
                                                                            horses, or other
                                                                            equines access to
                                                                            narasin
                                                                            formulations.
                                                                            Ingestion of narasin
                                                                            by these species has
                                                                            been fatal. Do not
                                                                            feed to chickens
                                                                            producing eggs for
                                                                            human consumption.
                                                                            Narasin and
                                                                            nicarbazin as
                                                                            provided by No.
                                                                            058198 in Sec.
                                                                            510.600(c) of this
                                                                            chapter.

[[Page 427]]

 
(v) 13.6 to 40.9..................     Salinomycin  Broiler chickens: For  Feed as the sole               058198
                                     sodium, 40 to   the prevention of      ration for 21
                                                60   mortality caused by    consecutive days.
                                                     necrotic enteritis     Feed to chickens
                                                     associated with        that are at risk of
                                                     Clostridium            developing, but not
                                                     perfringens; and for   yet showing clinical
                                                     the prevention of      signs of, necrotic
                                                     coccidiosis caused     enteritis associated
                                                     by Eimeria tenella,    with Clostridium
                                                     E. necatrix, E.        perfringens. Not
                                                     acervulina, E.         approved for use
                                                     maxima, E. brunetti,   with pellet binders.
                                                     and E. mivati..        To assure
                                                                            responsible
                                                                            antimicrobial drug
                                                                            use in broiler
                                                                            chickens, treatment
                                                                            administration must
                                                                            begin on or before
                                                                            18 days of age. The
                                                                            safety of avilamycin
                                                                            has not been
                                                                            established in
                                                                            chickens intended
                                                                            for breeding
                                                                            purposes. Avilamycin
                                                                            has not been
                                                                            demonstrated to be
                                                                            effective in broiler
                                                                            chickens showing
                                                                            clinical signs of
                                                                            necrotic enteritis
                                                                            prior to the start
                                                                            of medication. Do
                                                                            not feed to laying
                                                                            hens producing eggs
                                                                            for human
                                                                            consumption. May be
                                                                            fatal if fed to
                                                                            adult turkeys or to
                                                                            horses. Salinomycin
                                                                            as provided by No.
                                                                            016592 in Sec.
                                                                            510.600(c) of this
                                                                            chapter..
----------------------------------------------------------------------------------------------------------------

    (2) Swine--

----------------------------------------------------------------------------------------------------------------
                                     Combinationin
      Avilamycin in grams/ton          grams/ton     Indications for use        Limitations           Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 73............................  ..............  Weaned pigs less than  Feed as the sole               058198
                                                     14 weeks of age: For   ration for 21
                                                     the reduction in       consecutive days. To
                                                     incidence and          assure responsible
                                                     overall severity of    antimicrobial drug
                                                     diarrhea in the        use in pigs, do not
                                                     presence of            administer to pigs
                                                     pathogenic             14 weeks of age or
                                                     Escherichia coli in    older.
                                                     groups of weaned
                                                     pigs.
(ii) [Reserved]...................
----------------------------------------------------------------------------------------------------------------


[80 FR 61297, Oct. 13, 2015, as amended at 80 FR 76387, Dec. 9, 2015; 81 
FR 17609, Mar. 30, 2016; 81 FR 48703, July 26, 2016; 81 FR 59134, Aug. 
29, 2016; 81 FR 67152, Sept. 30, 2016; 82 FR 11509, Feb. 24, 2017; 83 FR 
14587, Apr. 5, 2018; 83 FR 64741, Dec. 18, 2018; 84 FR 8974, Mar. 13, 
2019; 84 FR 33001, July 11, 2019; 85 FR 4209, Jan. 24, 2020; 85 FR 
45308, July 28, 2020; 86 FR 13188, Mar. 8, 2021; 86 FR 14821, Mar. 19, 
2021]



Sec. 558.76  Bacitracin methylenedisalicylate.

    (a) Specifications. (1) Type A medicated articles containing 10, 25, 
30, 40, 50, 60, or 75 grams bacitracin methylenedisalicylate per pound.
    (2) Type A medicated article containing 50 grams bacitracin 
methylenedisalicylate per pound.
    (b) Sponsors. See sponsors in Sec. 510.600(c) of this chapter as 
follows:
    (1) No. 054771 for use of products in paragraph (a)(1) of this 
section as in paragraph (d) of this section.
    (2) No. 069254 for use of product in paragraph (a)(2) of this 
section as in paragraph (d) of this section.
    (c) Related tolerances. See Sec. 556.70 of this chapter.
    (d) Conditions of use. (1) It is used as follows:

[[Page 428]]



----------------------------------------------------------------------------------------------------------------
          Bacitracin            Combination in grams
 methylenedisalicylate amount      per ton (g/ton)       Indications for use         Limitations        Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 4 to 50 g/ton............  ......................  Chickens, turkeys, and  ......................     054771
                                                        pheasants: For
                                                        increased rate of
                                                        weight gain and
                                                        improved feed
                                                        efficiency.
(ii) 4 to 50 g/ton...........  ......................  Broiler and             ......................     069254
                                                        replacement chickens,
                                                        growing turkeys, and
                                                        growing pheasants:
                                                        For increased rate of
                                                        weight gain and
                                                        improved feed
                                                        efficiency.
(iii) 5 to 20 g/ton..........  ......................  Quail not over 5 weeks  ......................     054771
                                                        of age: For increased
                                                        rate of weight gain
                                                        and improved feed
                                                        efficiency.
(iv) 5 to 20 g/ton...........  ......................  Growing quail: For      For use in quail not       069254
                                                        increased rate of       over 5 weeks of age.
                                                        weight gain and
                                                        improved feed
                                                        efficiency.
(v) 10 to 25 g/ton...........  ......................  Chickens: For           For first 7 months of      054771
                                                        increased egg           production.
                                                        production and
                                                        improved feed
                                                        efficiency for egg
                                                        production.
(vi) 10 to 30 g/ton..........  ......................  Swine: For increased    For growing and            054771
                                                        rate of weight gain     finishing swine.
                                                        and improved feed
                                                        efficiency.
(vii) 50 g/ton...............  ......................  Broiler chickens: As    Feed continuously as       054771
                                                        an aid in the           sole ration.
                                                        prevention of
                                                        necrotic enteritis
                                                        caused or complicated
                                                        by Clostridium spp.
                                                        or other organisms
                                                        susceptible to
                                                        bacitracin.
                                                        Replacement chickens:
                                                        As an aid in the
                                                        prevention of
                                                        necrotic enteritis
                                                        caused or complicated
                                                        by Clostridium spp.
                                                        or other organisms
                                                        susceptible to
                                                        bacitracin.
(viii) 100 to 200 g/ton......  ......................  Broiler chickens: As    Feed continuously as       054771
                                                        an aid in the control   sole ration. Start at
                                                        of necrotic enteritis   first clinical signs
                                                        caused or complicated   of disease, vary
                                                        by Clostridium spp.     dosage based on
                                                        or other organisms      severity of
                                                        susceptible to          infection, administer
                                                        bacitracin.             continuously for 5 to
                                                        Replacement chickens:   7 days or as long as
                                                        As an aid in the        clinical signs
                                                        control of necrotic     persist, then reduce
                                                        enteritis caused or     medication to
                                                        complicated by          prevention level (50
                                                        Clostridium spp. or     g/ton).
                                                        other organisms
                                                        susceptible to
                                                        bacitracin.
(ix) 200 g/ton...............  ......................  Turkeys: As an aid in   Feed continuously as       054771
                                                        the control of          the sole ration.
                                                        transmissible
                                                        enteritis in growing
                                                        turkeys complicated
                                                        by organisms
                                                        susceptible to
                                                        bacitracin
                                                        methylenedisalicylate
                                                        . Quail: For the
                                                        prevention of
                                                        ulcerative enteritis
                                                        in growing quail due
                                                        to Clostridium
                                                        colinum susceptible
                                                        to bacitracin
                                                        methylenedisalicylate.
(x) 250 g/ton................  ......................  1. Growing/finishing    As the sole ration.        054771
                                                        swine: For control of   Not for use in swine
                                                        swine dysentery         weighing more than
                                                        Treponema               250 pounds. Diagnosis
                                                        hyodysenteriae on       should be confirmed
                                                        premises with history   by a veterinarian a
                                                        of swine dysentery      when results are not
                                                        but where signs of      satisfactory.
                                                        the disease have not
                                                        yet occurred; or
                                                        following an approved
                                                        treatment of the
                                                        disease condition.
                                                       2. Pregnant sows: For   As the sole ration.
                                                        control of              Feed to sows from 14
                                                        clostridial enteritis   days before through
                                                        caused by C.            21 days after
                                                        perfringens in          farrowing on premises
                                                        suckling piglets.       with a history of
                                                                                clostridial scours.
                                                                                Diagnosis should be
                                                                                confirmed by
                                                                                veterinarian when
                                                                                results are not
                                                                                satisfactory.

[[Page 429]]

 
(xi) To provide 70 mg per      ......................  Feedlot beef cattle:    Administer                 054771
 head per day.                                          For reduction in the    continuously
                                                        number of liver         throughout the
                                                        condemnations due to    feeding period.
                                                        abscesses.
(xii) To provide 70 mg per     ......................  Beef steers and         Administer                 069254
 head per day.                                          heifers fed in          continuously
                                                        confinement for         throughout the
                                                        slaughter: For          feeding period.
                                                        reduction in the
                                                        number of liver
                                                        condemnations due to
                                                        abscesses.
(xiii) To provide 250 mg per   ......................  Feedlot beef cattle:    Administer                 054771
 head per day.                                          For reduction in the    continuously for 5
                                                        number of liver         days then discontinue
                                                        condemnations due to    for subsequent 25
                                                        abscesses.              days, repeat the
                                                                                pattern during the
                                                                                feeding period.
(xiv) To provide 250 mg per    ......................  Beef steers and         Administer                 069254
 head per day.                                          heifers fed in          continuously for 5
                                                        confinement for         days then discontinue
                                                        slaughter: For          for subsequent 25
                                                        reduction in the        days, repeat the
                                                        number of liver         pattern during the
                                                        condemnations due to    feeding period.
                                                        abscesses.
----------------------------------------------------------------------------------------------------------------

    (2) Bacitracin methylenedisalicylate may also be used in combination 
with:
    (i) Amprolium as in Sec. 558.55.
    (ii) Amprolium and ethopabate as in Sec. 558.58.
    (iii) Chlortetracycline as in Sec. 558.128.
    (iv) Clopidol as in Sec. 558.175.
    (v) Decoquinate as in Sec. 558.195.
    (vi) Diclazuril as in Sec. 558.198.
    (vii) Fenbendazole as in Sec. 558.258.
    (viii) Halofuginone as in Sec. 558.265.
    (ix) Ivermectin as in Sec. 558.300.
    (x) Lasalocid as in Sec. 558.311.
    (xi) Monensin as in Sec. 558.355.
    (xii) Narasin as in Sec. 558.363.
    (xiii) Narasin and nicarbazin as in Sec. 558.364.
    (xiv) Nicarbazin as in Sec. 558.366.
    (xv) Robenidine as in Sec. 558.515.
    (xvi) Salinomycin as in Sec. 558.550.
    (xvii) Semduramicin as in Sec. 558.555.
    (xviii) Zoalene as in Sec. 558.680.

[41 FR 10993, Mar. 15, 1976]

    Editorial Notes 1. For Federal Register citations affecting Sec. 
558.76, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and at www.govinfo.gov.

    2. At 80 FR 78970, Dec. 18, 2015, Sec. 558.76 was amended by 
removing and reserving paragraph (d)(3)(xiii); however, the amendment 
could not be incorporated because the paragraph did not exist.



Sec. 558.78  Bacitracin zinc.

    (a) Specifications. Type A medicated articles containing bacitracin 
zinc equivalent to 10, 25, 40, or 50 grams per pound bacitracin.
    (b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
    (c) Related tolerances. See Sec. 556.70 of this chapter.
    (d) Conditions of use. (1) It is used as follows:

----------------------------------------------------------------------------------------------------------------
Bacitracin zinc in grams per   Combinations in grams
             ton                      per ton            Indications for use         Limitations        Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 4 to 50.................  .......................  Chickens: for           Growing chickens......     054771
                                                        increased rate of
                                                        weight gain and
                                                        improved feed
                                                        efficiency.
(ii) 4 to 50................  .......................  Turkeys and pheasants:  Growing turkeys and        054771
                                                        for increased rate of   pheasants.
                                                        weight gain and
                                                        improved feed
                                                        efficiency.
(iii) 5 to 20...............  .......................  Quail; for increased    Growing quail; feed as     054771
                                                        rate of weight gain     the Type C feed to
                                                        and improved feed       starting quail
                                                        efficiency.             through 5 weeks of
                                                                                age.
(iv) 10 to 25...............  .......................  Laying chickens;        ......................     054771
                                                        improved feed
                                                        efficiency and
                                                        increased egg
                                                        production.
(v) 10 to 50................  .......................  Swine; increased rate   Growing and finishing      054771
                                                        of weight gain and      swine.
                                                        improved feed
                                                        efficiency.
(vi) 20.....................  .......................  Growing-finishing       In Type C feed........     054771
                                                        swine; increased rate
                                                        of weight gain.

[[Page 430]]

 
(vii) 20 to 40..............  .......................  Growing-finishing       ......do..............     054771
                                                        swine; improved feed
                                                        efficiency.
----------------------------------------------------------------------------------------------------------------

    (2) It is used in feed for growing cattle at 35 to 70 milligrams per 
head per day as follows:
    (i) To aid in stimulating growth and improving feed efficiency.
    (ii) For increased rate of weight gain and improved feed efficiency; 
see sponsor 054771.
    (3) Bacitracin zinc may also be used in combination with:
    (i) Amprolium and ethopabate as in Sec. 558.58.
    (ii) Clopidol as in Sec. 558.175.
    (iii) Decoquinate as in Sec. 558.195.
    (iv) Lasalocid as in Sec. 558.311.
    (v) Monensin as in Sec. 558.355.
    (vi) Naracin as in Sec. 558.363.
    (vii) Nicarbazin as in Sec. 558.366.
    (viii) Robenidine as in Sec. 558.515.
    (ix) Salinomycin as in Sec. 558.550.

[41 FR 10994, Mar. 15, 1976]

    Editorial Note: For Federal Register citations affecting Sec. 
558.78, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and at www.govinfo.gov.



Sec. 558.95  Bambermycins.

    (a) Specifications. Type A medicated articles containing 2, 4, or 10 
grams bambermycins per pound.
    (b) Sponsors. See sponsors in Sec. 510.600(c) of this chapter as 
follows:
    (1) No. 016592: 2, 4, and 10 grams per pound for use as in 
paragraphs (e)(1) through (4) of this section.
    (2) No. 012286: 2 grams for use as in paragraph (e)(2) of this 
section and 0.4 and 2 grams per pound for use as in paragraph (e)(3) of 
this section.
    (c) Related tolerances. See Sec. 556.75 of this chapter.
    (d) Special considerations. (1) Bambermycins liquid Type B feeds may 
be manufactured from dry bambermycins Type A articles. The liquid Type B 
feeds must have a pH of 3.8 to 7.5, moisture content of 30 to 45 
percent.
    (2) The expiration date for the liquid Type B feed is 8 weeks after 
date of manufacture. The expiration date for the dry Type C feed made 
from the liquid Type B feed is 1 week after date of manufacture.
    (e) Conditions of use--(1) Chickens. Use in medicated feed as 
follows:

----------------------------------------------------------------------------------------------------------------
    Bambermycins in grams/ton      Indications for use        Limitations                    Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 1 to 2......................  Broiler chickens: For  Feed continuously as   016592.
                                   increased rate of      the sole ration.
                                   weight gain and
                                   improved feed
                                   efficiency.
(ii) [Reserved].................
----------------------------------------------------------------------------------------------------------------

    (2) Turkeys. Use in medicated feed as follows:

----------------------------------------------------------------------------------------------------------------
    Bambermycins in grams/ton      Indications for use        Limitations                    Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 1 to 2......................  Growing turkeys: For   Feed continuously as   012286, 016592.
                                   improved feed          the sole ration.
                                   efficiency.
(ii) 2..........................  Growing turkeys: For   Feed continuously as   012286, 016592.
                                   increased rate of      the sole ration.
                                   weight gain and
                                   improved feed
                                   efficiency.
----------------------------------------------------------------------------------------------------------------

    (3) Swine. Use in medicated feed as follows:

[[Page 431]]



----------------------------------------------------------------------------------------------------------------
    Bambermycins in grams/ton      Indications for use        Limitations                    Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 2...........................  Growing-finishing      Feed continuously as   012286, 016592.
                                   swine: For increased   the sole ration.
                                   rate of weight gain
                                   and improved feed
                                   efficiency.
(ii) 2 to 4.....................  Growing-finishing      Feed continuously as   012286, 016592.
                                   swine: For increased   the sole ration.
                                   rate of weight.
----------------------------------------------------------------------------------------------------------------

    (4) Cattle.

----------------------------------------------------------------------------------------------------------------
    Bambermycins in grams/ton      Indications for use        Limitations                    Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 1 to 4......................  Cattle fed in          Feed continuously at   016592.
                                   confinement for        a rate of 10 to 20
                                   slaughter: For         milligrams per head
                                   increased rate of      per day.
                                   weight gain and
                                   improved feed
                                   efficiency.
(ii) 2 to 80....................  Pasture cattle         Feed continuously on   016592.
                                   (slaughter, stocker,   a hand-fed basis at
                                   and feeder cattle,     a rate of 10 to 40
                                   and dairy and beef     milligrams per head
                                   replacement            per day in 1 to 10
                                   heifers): For          pounds of
                                   increased rate of      supplemental Type C
                                   weight gain.           medicated feed.
----------------------------------------------------------------------------------------------------------------

    (iii) Used as a free-choice Type C medicated loose-mineral feed for 
pasture cattle (slaughter, stocker, and feeder cattle; and beef 
replacement heifers) as follows:
    (a) Specifications.

------------------------------------------------------------------------
                                  International Feed
           Ingredient                     No.               Percent
------------------------------------------------------------------------
Deflorinated phosphate (20.5%     6-01-080..........  42.50
 calcium, 18.5% phosphorus).
Sodium chloride (salt)..........  6-04-152..........  20.10
Calcium carbonate (38% calcium).  6-01-069..........  15.24
Corn distillers dried grains w/   5-28-236..........  9.57
 solubles.
Magnesium oxide.................  6-02-756..........  5.15
Vitamin and trace mineral premix  ..................  3.72
 *.
Mineral oil.....................  ..................  1.00
Yeast (primary dehydrated yeast)  7-05-533..........  0.75
Bambermycins Type A article (10   ..................  0.60
 g/lb).
Iron oxide......................  6-02-431..........  0.50
Magnesium sulfate (67%).........  6-02-758..........  0.32
Selenium premix (270 mg/lb) *...  ..................  0.21
Copper sulfate..................  6-01-720..........  0.18
Potassium sulfate (0.33%).......  6-06-098..........  0.16
------------------------------------------------------------------------
*Content of vitamin/trace mineral premix may be varied. However, they
  should be comparable to those used for other free-choice feeds.
  Formulation modifications require FDA approval prior to marketing.
  Selenium must comply with 21 CFR 573.920. Ethylenediamine
  dihydroiodide (EDDI) should comply with FDA Compliance Policy Guides
  Sec. 651.100 (CPG 7125.18).

    (b) Amount per ton. 120 grams.
    (c)Indications for use. For increased rate of weight gain.
    (d) Limitations. For free-choice feeding to pasture cattle 
(slaughter, stocker, and feeder cattle; and beef replacement heifers). 
Feed a nonmedicated commercial mineral product for 6 weeks to stabilize 
consumption between 2.66 and 10.66 ounces per head per day. Feed 
continuously to provide 10 to 40 milligrams bambermycins per head per 
day. Daily bambermycins intakes in excess of 20 mg/head/day have not 
been shown to be more effective than 20 mg/head/day.
    (iv) Use free-choice Type C medicated feeds for pasture cattle 
(slaughter, stocker, and feeder cattle; and beef replacement heifers) as 
follows:
    (a) Amount. Feed continuously to provide 10 to 40 milligrams of 
bambermycins per head per day.
    (b) Indications for use. For increased rate of weight gain.
    (c) Limitations. Each use in a free-choice Type C medicated feed 
must be the subject of an approved new animal drug application (NADA) or 
supplemental NADA as required by 21 CFR 510.455. Daily bambermycins 
intakes in excess of 20 mg/head/day have not been

[[Page 432]]

shown to be more effective than 20 mg/head/day.
    (v) Used as a free-choice Type C medicated loose mineral feed for 
pasture cattle (slaughter, stocker, and feeder cattle; and dairy and 
beef replacement heifers) as follows:
    (A) Specifications.

------------------------------------------------------------------------
                                  International Feed
           Ingredient                     No.               Percent
------------------------------------------------------------------------
Deflorinated phosphate (20.5%     6-01-080..........  42.50
 calcium, 18.5% phosphorus).
Sodium chloride (salt)..........  6-04-152..........  20.10
Calcium carbonate (38% calcium).  6-01-069..........  15.45
Corn distillers dried grains w/   5-28-236..........  9.57
 solubles.
Magnesium oxide.................  6-02-756..........  5.15
Vitamin and trace mineral premix  ..................  3.72
 *.
Mineral oil.....................  ..................  1.00
Yeast (primary dehydrated yeast)  7-05-533..........  0.75
Bambermycins Type A article (10   ..................  0.60
 g/lb).
Iron oxide......................  6-02-431..........  0.50
Magnesium sulfate (67%).........  6-02-758..........  0.32
Copper sulfate..................  6-01-720..........  0.18
Potassium sulfate (0.33%).......  6-06-098..........  0.16
------------------------------------------------------------------------
* Content of vitamin/trace mineral premix may be varied. However, they
  should be comparable to those used for other free-choice feeds.
  Formulation modifications require FDA approval prior to marketing.
  Ethylenediamine dihydroiodide (EDDI) should comply with FDA Compliance
  Policy Guides Sec. 651.100 (CPG 7125.18).

    (B) Amount per ton. 120 grams.
    (C) Indications for use. For increased rate of weight gain.
    (D) Limitations. For free-choice feeding to pasture cattle 
(slaughter, stocker, and feeder cattle; and dairy and beef replacement 
heifers). Feed a non-medicated commercial mineral product for 6 weeks to 
stabilize consumption between 2.66 and 10.66 ounces per head per day. 
Feed continuously to provide 10 to 40 milligrams bambermycins per head 
per day. Daily bambermycins intakes in excess of 20 mg/head/day have not 
been shown to be more effective than 20 mg/head/day.
    (5) Combinations. Bambermycins may also be used in combination with:
    (i) Amprolium as in Sec. 558.55.
    (ii) Amprolium and ethopabate as in Sec. 558.58.
    (iii) Clopidol as in Sec. 558.175.
    (iv) Diclazuril as in Sec. 558.198.
    (v) Halofuginone as in Sec. 558.265.
    (vi) Lasalocid as in Sec. 558.311.
    (vii) Monensin as in Sec. 558.355.
    (viii) Narasin as in Sec. 558.363.
    (ix) Narasin and nicarbazin as in Sec. 558.364.
    (x) Nicarbazin as in Sec. 558.366.
    (xi) Salinomycin as in Sec. 558.550.
    (xii) Zoalene as in Sec. 558.680.

[40 FR 13959, Mar. 27, 1975]

    Editorial Note: For Federal Register citations affecting Sec. 
558.95, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and at www.govinfo.gov.



Sec. 558.115  Carbadox.

    (a) Approvals. Type A medicated articles: 2.2. percent (10 grams per 
pound) to 066104 in Sec. 510.600(c) of this chapter.
    (b) Related tolerances. See Sec. 556.100 of this chapter.
    (c) Special considerations. Do not use in Type B or Type C medicated 
feeds containing bentonite.
    (d) Conditions of use. It is used for swine as follows:
    (1) Amount per ton. 10-25 grams (0.0011-0.00275 percent).
    (i) Indications for use. For increase in rate of weight gain and 
improvement of feed efficiency.
    (ii) Limitations. Not for use in pregnant swine or swine intended 
for breeding purposes. Do not feed to swine within 42 days of slaughter.
    (2) Amount per ton. 50 grams (0.0055 percent).
    (i) Indications for use. For control of swine dysentery (vibrionic 
dysentery, bloody scours, or hemorrhagic dysentery); control of 
bacterial swine enteritis (salmonellosis or necrotic enteritis caused by 
Salmonella choleraesuis); increased rate of weight gain and improved 
feed efficiency.
    (ii) Limitations. Not for use in pregnant swine or swine intended 
for breeding purposes. Do not feed to swine within 42 days of slaughter.
    (3) Amount per ton. Carbadox 50 grams (0.0055 percent) plus pyrantel 
tartrate, 96 grams (0.0106 percent).

[[Page 433]]

    (i) Indications for use. For control of swine dysentery (vibrionic 
dysentery, bloody scours, or hemorrhagic dysentery); control of 
bacterial swine enteritis (salmonellosis or necrotic enteritis caused by 
Salmonella choleraesuis); aid in the prevention of migration and 
establishment of large roundworm (Ascaris suum) infections; aid in the 
prevention of establishment of nodular worm (Oesophagostomum) 
infections.
    (ii) Limitations. Do not feed to swine over 75 pounds; do not feed 
within 10 weeks of slaughter; consult a veterinarian before feeding to 
severely debilitated animals; feed continuously as sole ration. Do not 
use in complete feeds containing less than 15 percent crude protein.
    (4) Carbadox may also be used in combination with oxytetracycline as 
in Sec. 558.450.

[40 FR 13959, Mar. 27, 1975, as amended at 40 FR 45164, Oct. 1, 1975; 40 
FR 57798, Dec. 12, 1975; 42 FR 761, Jan. 4, 1977; 51 FR 7396, Mar. 3, 
1986; 63 FR 59216, Nov. 3, 1998; 66 FR 47963, Sept. 17, 2001; 69 FR 
51173, Aug. 18, 2004; 82 FR 21691, May 10, 2017]



Sec. 558.128  Chlortetracycline.

    (a) Specifications. Type A medicated articles containing either 
chlortetracycline calcium complex equivalent to chlortetracycline 
hydrochloride, or for products intended for use in milk replacer, 
chlortetracycline hydrochloride.
    (b) Sponsors. See sponsors in Sec. 510.600(c) of this chapter as 
follows:
    (1) No. 054771: 50, 70, 80, 90, or 100 grams per pound (g/lb) Type A 
medicated article.
    (2) No. 066104: 10, 20, 30, 50, 70, or 100 g/lb of Type A medicated 
article.
    (3) No. 069254: 50, 90, or 100 g/lb of Type A medicated article.
    (c) Related tolerances. See Sec. 556.150 of this chapter.
    (d) Special considerations. (1) Federal law restricts medicated feed 
containing this veterinary feed directive (VFD) drug to use by or on the 
order of a licensed veterinarian. See Sec. 558.6 for additional 
requirements.
    (2) The expiration date of VFDs for chlortetracycline medicated 
feeds must not exceed 6 months from the date of issuance. VFDs for 
chlortetracycline shall not be refilled.
    (3) In milk replacers or starter feed; include on labeling the 
warning: ``A withdrawal period has not been established for this product 
in preruminating calves. Do not use in calves to be processed for 
veal.''
    (4) Manufacture for use in free-choice feeds as in paragraph 
(e)(4)(iii) of this section must conform to Sec. 510.455 of this 
chapter.
    (5) When manufactured for use as in paragraph (e)(5)(iii) of this 
section, include on labeling the warning: ``Psittacosis, avian 
chlamydiosis, or ornithosis is a reportable communicable disease, 
transmissible between wild and domestic birds, other animals, and man. 
Contact appropriate public health and regulatory officials.''
    (e) Conditions of use--(1) Chickens. It is used as follows:

----------------------------------------------------------------------------------------------------------------
                               Combination in grams/
  Chlortetracycline amount              ton              Indications for use         Limitations        Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 100 to 200 g/ton........  .......................  Chickens: For control   Feed continuously for      054771
                                                        of infectious           7 to 14 days. For No.     066104
                                                        synovitis caused by     066104: Do not feed       069254
                                                        Mycoplasma synoviae     to chickens producing
                                                        susceptible to          eggs for human
                                                        chlortetracycline.      consumption.
(ii) 100 to 200 g/ton.......  Clopidol, 113.5........  Broiler and             Feed continuously as       016592
                                                        replacement chickens:   the sole ration from
                                                        As an aid in the        the time chicks are
                                                        prevention of           placed in floor pens
                                                        coccidiosis caused by   for 7 to 14 days. Do
                                                        Eimeria tenella, E.     not feed to chickens
                                                        necatrix, E.            over 16 weeks of age.
                                                        acervulina, E.          Do not feed to
                                                        maxima, E. mivati,      chickens producing
                                                        and E. brunetti; and    eggs for human
                                                        for control of          consumption.
                                                        infectious synovitis    Chlortetracycline as
                                                        caused by M. synoviae   provided by No.
                                                        susceptible to          054771; clopidol as
                                                        chlortetracycline.      provided by No.
                                                                                016592 in Sec.
                                                                                510.600(c) of this
                                                                                chapter.

[[Page 434]]

 
(iii) 100 to 200 g/ton......  Decoquinate, 27.2......  Chickens: For           Feed continuously for      054771
                                                        prevention of           7 to 14 days.
                                                        coccidiosis caused by   Bentonite should not
                                                        Eimeria tenella, E.     be used in
                                                        necatrix, E. mivati,    decoquinate feeds. Do
                                                        E. acervulina, E.       not feed to chickens
                                                        maxima, and E.          producing eggs for
                                                        brunetti; and for       human consumption.
                                                        control of infectious  Chlortetracycline and
                                                        synovitis caused by     decoquinate as
                                                        M, synoviae             provided by No.
                                                        susceptible to          054771 in Sec.
                                                        chlortetracycline.      510.600(c) of this
                                                                                chapter.
(iv) 100 g/ton..............  Robenidine, 30.........  Broiler and fryer       Feed continuously as       054771
                                                        chickens: As an aid     sole ration. Do not
                                                        in the prevention of    use this product in
                                                        coccidiosis caused by   feeds conta.
                                                        E. mivati, E.          Chlortetracycline and
                                                        brunetti, E. tenella,   robenidine as
                                                        E. acervulina, E.       provided by No.
                                                        maxima, and E.          054771 in Sec.
                                                        necatrix; as an aid     510.600(c) of this
                                                        in the control of       chapter.
                                                        chronic respiratory
                                                        disease (CRD) caused
                                                        by Mycoplasma
                                                        gallisepticum
                                                        susceptible to
                                                        chlortetracycline;
                                                        and as an aid in the
                                                        control of infectious
                                                        synovitis caused by
                                                        M. synoviae
                                                        susceptible to
                                                        chlortetracycline.
(v) 200 to 400 g/ton........  .......................  Chickens: For the       Feed continuously for      054771
                                                        control of chronic      7 to 14 days. For No.     066104
                                                        respiratory disease     066104: Do not feed       069254
                                                        (CRD) and air sac       to chickens producing
                                                        infection caused by     eggs for human
                                                        M. gallisepticum and    consumption.
                                                        Escherichia coli
                                                        susceptible to
                                                        chlortetracycline.
(vi) 200 g/ton..............  Amprolium, 227 and       For chickens where      Use in low calcium         054771
                               ethopabate, 3.6.         immunity to             feed containing 0.8%
                                                        coccidiosis is not      dietary calcium and
                                                        desired: For            1.5% sodium sulfate;
                                                        prevention of           feed continuously as
                                                        coccidiosis; and for    sole ration for 7 to
                                                        treatment of chronic    14 days; do not feed
                                                        respiratory disease     to chickens producing
                                                        (CRD) caused by M.      eggs for human
                                                        gallisepticum           consumption.
                                                        susceptible to          Chlortetracycline as
                                                        chlortetracycline.      provided by No.
                                                                                054771; amprolium and
                                                                                ethopabate as
                                                                                provided by No.
                                                                                016592 in Sec.
                                                                                510.600(c) of this
                                                                                chapter.
(vii) 200 g/ton.............  Decoquinate, 27.2......  Broilers: As an aid in  Feed continuously as       054771
                                                        the prevention of       the sole ration for
                                                        coccidiosis caused by   no more than 8 weeks.
                                                        Eimeria tenella, E.     Use in low calcium
                                                        necatrix, E.            feed containing 0.8%
                                                        acervulina, E.          dietary calcium.
                                                        mivati, E. maxima,      Bentonite should not
                                                        and E. brunetti; and    be used in
                                                        for the treatment of    decoquinate feeds. Do
                                                        chronic respiratory     not feed to chickens
                                                        disease (air sac        producing eggs for
                                                        infection) and the      human consumption.
                                                        prevention of          Chlortetracycline and
                                                        synovitis.              decoquinate as
                                                                                provided by No.
                                                                                054771 in Sec.
                                                                                510.600(c) of this
                                                                                chapter.
(viii) 200 g/ton............  Robenidine 30..........  Broiler and fryer       Feed continuously as       054771
                                                        chickens: As an aid     sole ration. Do not
                                                        in the prevention of    use this product in
                                                        coccidiosis caused by   feeds containing
                                                        E. mivati, E.           bentonite. Do not
                                                        brunetti, E. tenella,   feed to chickens
                                                        E. acervulina, E.       producing eggs for
                                                        maxima, and E.          human consumption.
                                                        necatrix; as an aid     Withdraw 5 days prior
                                                        in the control of       to slaughter.
                                                        chronic respiratory    Chlortetracycline and
                                                        disease (CRD) caused    robenidine as
                                                        by M. gallisepticum     provided by No.
                                                        susceptible to          054771 in Sec.
                                                        chlortetracycline;      510.600(c) of this
                                                        and as an aid in the    chapter.
                                                        control of infectious
                                                        synovitis caused by
                                                        M. synoviae
                                                        susceptible to
                                                        chlortetracycline.

[[Page 435]]

 
(ix) 500 g/ton..............  .......................  Chickens: For the       1. Feed for 5 days. To     054771
                                                        reduction of            sponsor No. 054771        069254
                                                        mortality due to E.     under NADA 048-761
                                                        coli infections         and No. 069254 under
                                                        susceptible to          ANADA 200-510: zero
                                                        chlortetracycline.      withdrawal time.
                                                                               2. Feed for 5 days;        054771
                                                                                withdraw 24 hours         066104
                                                                                prior to slaughter.       069254
                                                                                Do not feed to
                                                                                chickens producing
                                                                                eggs for human
                                                                                consumption.
(x) 500 g/ton...............  Monensin, 90 to 110....  Chickens: As an aid in  Feed for 5 days as the     054771
                                                        the reduction of        sole ration. Do not       069254
                                                        mortality due to E.     feed to laying
                                                        coli infections         chickens. Not to be
                                                        susceptible to          fed continuously for
                                                        chlortetracycline;      more than 5 days. Do
                                                        and as an aid in the    not feed to chickens
                                                        prevention of           over 16 weeks of age.
                                                        coccidiosis caused by   Withdraw 24 hours
                                                        Eimeria tenella, E.     before slaughter. See
                                                        necatrix, E.            Sec. 558.355(d) of
                                                        acervulina, E.          this chapter.
                                                        maxima, E. brunetti,    Chlortetracycline as
                                                        and E. mivati.          provided by No.
                                                                                054771; monensin as
                                                                                provided by No.
                                                                                058198 in Sec.
                                                                                510.600(c) of this
                                                                                chapter.
(xi) 500 g/ton..............  Robenidine, 30.........  Broiler and fryer       Feed continuously as       054771
                                                        chickens: As an aid     sole ration for up to
                                                        in the prevention of    5 days. Do not use
                                                        coccidiosis caused by   this product in feeds
                                                        Eimeria mivati, E.      containing bentonite.
                                                        brunetti, E. tenella,   Do not feed to
                                                        E. acervulina, E.       chickens producing
                                                        maxima, and E.          eggs for human
                                                        necatrix; as an aid     consumption. Withdraw
                                                        in the reduction of     5 days prior to
                                                        mortality due to E.     slaughter.
                                                        coli susceptible to    Chlortetracycline and
                                                        chlortetracycline.      robenidine as
                                                                                provided by No.
                                                                                054771 in Sec.
                                                                                510.600(c) of this
                                                                                chapter.
(xii) 500 g/ton.............  Salinomycin, 40 to 60..  Broiler chickens: As    For use in low calcium     016592
                                                        an aid in the           feeds containing 0.8%     054771
                                                        prevention of           calcium. Not approved     069254
                                                        coccidiosis caused by   for use with pellet
                                                        Eimeria tenella, E.     binders. Not to be
                                                        necatrix, E.            fed continuously for
                                                        acervulina, E.          more than 5 days. Do
                                                        maxima, E. brunetti,    not feed to laying
                                                        and E. mivati; and as   chickens producing
                                                        an aid in the           eggs for human
                                                        reduction of            consumption. Withdraw
                                                        mortality due to E.     24 hours before
                                                        coli susceptible to     slaughter. May be
                                                        chlortetracycline.      fatal if accidentally
                                                                                fed to adult turkeys
                                                                                or horses.
                                                                                Chlortetracycline as
                                                                                provided by Nos.
                                                                                054771 or 069254;
                                                                                salinomycin as
                                                                                provided by Nos.
                                                                                054771 or 016592 in
                                                                                Sec. 510.600(c) of
                                                                                this chapter.
----------------------------------------------------------------------------------------------------------------

    (2) Turkeys. It is used as follows:

----------------------------------------------------------------------------------------------------------------
                               Combination in grams/
  Chlortetracycline amount              ton              Indications for use         Limitations        Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 200 g/ton...............  .......................  Turkeys: For control    Feed continuously for      054771
                                                        of infectious           7 to 14 days. Do not      066104
                                                        synovitis caused by     feed to turkeys           069254
                                                        M. synoviae             producing eggs for
                                                        susceptible to          human consumption.
                                                        chlortetracycline.
(ii) 400 g/ton..............  .......................  1. Turkeys: For         Feed continuously for      054771
                                                        control of              7 to 14 days. Do not      066104
                                                        hexamitiasis caused     feed to turkeys           069254
                                                        by Hexamita             producing eggs for
                                                        meleagridis             human consumption.
                                                        susceptible to
                                                        chlortetracycline.
                              .......................  2. Turkey poults not    ......................     054771
                                                        over 4 weeks of age:                              066104
                                                        For reduction of                                  069254
                                                        mortality due to
                                                        paratyphoid caused by
                                                        Salmonella
                                                        typhimurium
                                                        susceptible to
                                                        chlortetracycline.

[[Page 436]]

 
(iii) 25 mg/lb of body        .......................  Turkeys: For control    Feed continuously for      054771
 weight.                                                of complicating         7 to 14 days. Do not      066104
                                                        bacterial organisms     feed to turkeys           069254
                                                        associated with         producing eggs for
                                                        bluecomb                human consumption.
                                                        (transmissible
                                                        enteritis;
                                                        coronaviral
                                                        enteritis)
                                                        susceptible to
                                                        chlortetracycline.
----------------------------------------------------------------------------------------------------------------

    (3) Swine. It is used as follows:

----------------------------------------------------------------------------------------------------------------
                               Combination in grams/
  Chlortetracycline amount              ton              Indications for use         Limitations        Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 50 to 100 g/ton.........  .......................  Swine: For reducing     ......................     054771
                                                        the incidence of                                  066104
                                                        cervical                                          069254
                                                        lymphadenitis (jowl
                                                        abscesses) caused by
                                                        Group E Streptococci
                                                        susceptible to
                                                        chlortetracycline.
(ii) 400 g/ton..............  .......................  Breeding swine: For     Feed continuously for      054771
                                                        the control of          not more than 14 days.    066104
                                                        leptospirosis                                     069254
                                                        (reducing the
                                                        incidence of abortion
                                                        and shedding of
                                                        leptospirae) caused
                                                        by Leptospira pomona
                                                        susceptible to
                                                        chlortetracycline.
(iii) 10 mg/lb of body        .......................  Swine: For treatment    Feed approximately 400     054771
 weight.                                                of bacterial            g/ton, varying with       066104
                                                        enteritis caused by     body weight and feed      069254
                                                        Escherichia coli and    consumption to
                                                        S. choleraesuis and     provide 10 mg/lb per
                                                        bacterial pneumonia     day. Feed for not
                                                        caused by Pasteurella   more than 14 days.
                                                        multocida susceptible   Withdraw 5 d prior to
                                                        to chlortetracycline;   slaughter for sponsor
                                                        for the control of      No. 069254 in Sec.
                                                        porcine proliferative   510.600(c) of this
                                                        enteropathies           chapter.
                                                        (ileitis) caused by
                                                        Lawsonia
                                                        intracellularis
                                                        susceptible to
                                                        chlortetracycline.
(iv) 10 mg/lb of body weight  Bacitracin               Swine: For treatment    Feed approximately 400     054771
                               methylenedisalicylate,   of bacterial            g/ton, varying with
                               10 to 30.                enteritis caused by     body weight and feed
                                                        E. coli and S.          consumption to
                                                        choleraesuis and        provide 10 mg/lb per
                                                        bacterial pneumonia     day. Feed for not
                                                        caused by P.            more than 14 days.
                                                        multocida susceptible   Chlortetracycline and
                                                        to chlortetracycline;   bacitracin
                                                        for the control of      methylenedisalicylate
                                                        porcine proliferative   as provided by No.
                                                        enteropathies           054771 in Sec.
                                                        (ileitis) caused by     510.600(c) of this
                                                        Lawsonia                chapter.
                                                        intracellularis
                                                        susceptible to
                                                        chlortetracycline;
                                                        and for increased
                                                        rate of weight gain
                                                        and improved feed
                                                        efficiency.
(v) 10 mg/lb of body weight.  Bacitracin               Swine: For treatment    Feed chlortetracycline     054771
                               methylenedisalicylate,   of bacterial            at approximately 400      069254
                               10 to 30.                enteritis caused by     g/ton of feed,
                                                        E. coli and S.          varying with body
                                                        choleraesuis and        weight and food
                                                        bacterial pneumonia     consumption, to
                                                        caused by P.            provide 10 mg/lb of
                                                        multocida susceptible   body weight. Feed for
                                                        to chlortetracycline;   not more than 14
                                                        and for increased       days. Withdraw 5 d
                                                        rate of weight gain     prior to slaughter
                                                        and improved feed       for sponsor No.
                                                        efficiency.             069254. Bacitracin
                                                                                methylenedisalicylate
                                                                                provided by No.
                                                                                054771;
                                                                                chlortetracycline
                                                                                provided by Nos.
                                                                                054771 and 069254 in
                                                                                Sec. 510.600(c) of
                                                                                this chapter.

[[Page 437]]

 
(vi) 10 mg/lb of body weight  Tiamulin hydrogen        For control of swine    Feed chlortetracycline     058198
                               fumarate, 35.            dysentery associated    at approximately 400      069254
                                                        with Brachyspira        g/ton of feed,
                                                        (formerly Serpulina     varying with body
                                                        or Treponema)           weight and food
                                                        hyodysenteriae          consumption, to
                                                        susceptible to          provide 10 mg/lb of
                                                        tiamulin and for        body weight. Feed
                                                        treatment of swine      continuously as the
                                                        bacterial enteritis     sole ration for 14
                                                        caused by E. coli and   days. Withdraw
                                                        Salmonella              medicated feed 2 days
                                                        choleraesuis            before slaughter.
                                                        sensitive to            Tiamulin as provided
                                                        chlortetracycline and   by Nos. 058198 or
                                                        treatment of            069254 in Sec.
                                                        bacterial pneumonia     510.600(c) of this
                                                        caused by P.            chapter.
                                                        multocida sensitive
                                                        to chlortetracycline.
----------------------------------------------------------------------------------------------------------------

    (4) Cattle. It is used as follows:

----------------------------------------------------------------------------------------------------------------
                                    Combination in grams/
     Chlortetracycline amount                ton            Indications for use       Limitations       Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 0.5 mg/lb of body weight daily  .....................  Beef cattle (over     Withdraw 48 hours        054771
                                                            700 lb): For          prior to slaughter.     066104
                                                            control of active     To sponsor Nos.         069254
                                                            infection of          054771 and 069254:
                                                            anaplasmosis caused   Zero withdrawal
                                                            by Anaplasma          time.
                                                            marginale
                                                            susceptible to
                                                            chlortetracycline.
(ii) 25 to 1,100 to provide 0.5 mg/ Lasalocid, 30 to 600.  Pasture cattle        Feed continuously on     054771
 lb of body weight daily.                                   (slaughter,           a hand-fed basis        069254
                                                            stocker, feeder       0.5 mg
                                                            cattle, beef          chlortetracycline
                                                            replacement           per lb. body weight
                                                            heifers) over 700     per day and not
                                                            pounds: For control   less than 60 mg or
                                                            of active infection   more than 300 mg
                                                            of anaplasmosis       lasalocid per head
                                                            caused by A.          daily in at least 1
                                                            marginale             pound of feed.
                                                            susceptible to        Daily lasalocid
                                                            chlortetracycline;    intakes in excess
                                                            and for increased     of 200 mg/head/day
                                                            rate of weight gain.  in pasture cattle
                                                                                  have not been shown
                                                                                  to be more
                                                                                  effective than 200
                                                                                  mg lasalocid/head/
                                                                                  day. Do not allow
                                                                                  horses or other
                                                                                  equines access to
                                                                                  feeds containing
                                                                                  lasalocid. No
                                                                                  withdrawal period
                                                                                  is required. A
                                                                                  withdrawal period
                                                                                  has not been
                                                                                  established for
                                                                                  this product in pre-
                                                                                  ruminating calves.
                                                                                  Do not use in
                                                                                  calves to be
                                                                                  processed for veal.
                                                                                  See Sec.
                                                                                  558.311(d) of this
                                                                                  chapter. Lasalocid
                                                                                  as provided by No.
                                                                                  054771 in Sec.
                                                                                  510.600(c) of this
                                                                                  chapter.
(iii) 0.5 to 2.0 mg/lb of body      .....................  Beef cattle and       In free-choice           054771
 weight daily.                                              nonlactating dairy    cattle feeds such       069254
                                                            cattle: As an aid     as feed blocks or
                                                            in the control of     salt-mineral mixes
                                                            active infection of   manufactured from
                                                            anaplasmosis caused   approved Type A
                                                            by A. marginale       articles. See
                                                            susceptible to        paragraph (d)(4) of
                                                            chlortetracycline.    this section.
(iv) 10 mg/lb of body weight daily  .....................  1. Calves, beef and   Feed approximately       054771
                                                            nonlactating dairy    400 g/ton, varying      066104
                                                            cattle: For           with body weight        069254
                                                            treatment of          and feed
                                                            bacterial enteritis   consumption to
                                                            caused by             provide 10 mg/lb
                                                            Escherichia coli      per day. Treat for
                                                            and bacterial         not more than 5
                                                            pneumonia caused by   days. In feed
                                                            Pasteurella           including milk
                                                            multocida organisms   replacers withdraw
                                                            susceptible to        10 days prior to
                                                            chlortetracycline.    slaughter. To
                                                                                  sponsor Nos. 054771
                                                                                  and 069254: zero
                                                                                  withdrawal time.
                                                                                  See paragraph
                                                                                  (d)(3) of this
                                                                                  section.

[[Page 438]]

 
                                                           2. Calves (up to 250  See paragraph (d)(3)     054771
                                                            lb): For the          of this section.        066104
                                                            treatment of                                  069254
                                                            bacterial enteritis
                                                            caused by E. coli
                                                            susceptible to
                                                            chlortetracycline.
(v) 10 mg/lb of body weight daily.  Laidlomycin, 5.......  Cattle fed in         Feed continuously at     054771
                                                            confinement for       a rate of 30 to 75
                                                            slaughter: For        mg laidlomycin
                                                            treatment of          propionate
                                                            bacterial enteritis   potassium per head
                                                            caused by E. coli     per day for not
                                                            and bacterial         more than 5 days. A
                                                            pneumonia caused by   withdrawal period
                                                            P. multocida          has not been
                                                            organisms             established for
                                                            susceptible to        this product in pre-
                                                            chlortetracycline;    ruminating calves.
                                                            and for increased     Do not use in
                                                            rate of weight and    calves to be
                                                            improved feed         processed for veal.
                                                            efficiency.           See Sec.
                                                                                  558.305(d) of this
                                                                                  chapter.
                                                                                  Laidlomycin as
                                                                                  provided by No.
                                                                                  054771 in Sec.
                                                                                  510.600(c) of this
                                                                                  chapter.
(vi) 10 mg/lb of body weight daily  Laidlomycin, 5 to 10.  Cattle fed in         Feed continuously at     054771
                                                            confinement for       a rate of 30 to 75
                                                            slaughter: For        mg laidlomycin
                                                            treatment of          propionate
                                                            bacterial enteritis   potassium per head
                                                            caused by E. coli     per day for not
                                                            and bacterial         more than 5 days. A
                                                            pneumonia caused by   withdrawal period
                                                            P. multocida          has not been
                                                            organisms             established for
                                                            susceptible to        this product in pre-
                                                            chlortetracycline;    ruminating calves.
                                                            and for improved      Do not use in
                                                            feed efficiency.      calves to be
                                                                                  processed for veal.
                                                                                  See Sec.
                                                                                  558.305(d) of this
                                                                                  chapter.
                                                                                  Laidlomycin as
                                                                                  provided by No.
                                                                                  054771 in Sec.
                                                                                  510.600(c) of this
                                                                                  chapter.
(vii) 500 to 2,000 to provide 10    Lasalocid, 10 to 30..  Cattle fed in         Feed continuously in     054771
 mg/lb of body weight daily.                                confinement for       complete feed for       069254
                                                            slaughter: For        not more than 5
                                                            treatment of          days to provide 10
                                                            bacterial enteritis   mg
                                                            caused by E. coli     chlortetracycline
                                                            and bacterial         per lb. body weight
                                                            pneumonia caused by   per day and not
                                                            P. multocida          less than 100 mg or
                                                            organisms             more than 360 mg
                                                            susceptible to        lasalocid per head
                                                            chlortetracycline;    per day. Do not
                                                            and for improved      allow horses or
                                                            feed efficiency.      other equines
                                                                                  access to feeds
                                                                                  containing
                                                                                  lasalocid. No
                                                                                  withdrawal period
                                                                                  is required. A
                                                                                  withdrawal period
                                                                                  has not been
                                                                                  established for
                                                                                  this product in pre-
                                                                                  ruminating calves.
                                                                                  Do not use in
                                                                                  calves to be
                                                                                  processed for veal.
                                                                                  See Sec.
                                                                                  558.311(d) of this
                                                                                  chapter. Lasalocid
                                                                                  as provided by No.
                                                                                  054771 in Sec.
                                                                                  510.600(c) of this
                                                                                  chapter.

[[Page 439]]

 
(viii) 500 to 1,200 to provide 10   Lasalocid, 25 to 30..  Cattle fed in         Feed continuously in     054771
 mg/lb of body weight daily.                                confinement for       complete feed for       069254
                                                            slaughter: For        not more than 5
                                                            treatment of          days to provide 10
                                                            bacterial enteritis   mg
                                                            caused by E. coli     chlortetracycline
                                                            and bacterial         per lb. body weight
                                                            pneumonia caused by   per day and not
                                                            P. multocida          less than 250 mg or
                                                            organisms             more than 360 mg
                                                            susceptible to        lasalocid per head
                                                            chlortetracycline;    per day. Do not
                                                            and for increased     allow horses or
                                                            rate of weight gain   other equines
                                                            and improved feed     access to feeds
                                                            efficiency.           containing
                                                                                  lasalocid. No
                                                                                  withdrawal period
                                                                                  is required. A
                                                                                  withdrawal period
                                                                                  has not been
                                                                                  established for
                                                                                  this product in pre-
                                                                                  ruminating calves.
                                                                                  Do not use in
                                                                                  calves to be
                                                                                  processed for veal.
                                                                                  See Sec.
                                                                                  558.311(d) of this
                                                                                  chapter. Lasalocid
                                                                                  as provided by No.
                                                                                  054771 in Sec.
                                                                                  510.600(c) of this
                                                                                  chapter.
(ix) 500 to 4,000 to provide 10 mg/ Lasalocid, 30 to 600.  Pasture cattle        Feed continuously on     054771
 lb of body weight daily.                                   (slaughter,           a hand-fed basis        069254
                                                            stocker, feeder       for not more than 5
                                                            cattle, dairy and     days to provide 10
                                                            beef replacement      mg
                                                            heifers): For         chlortetracycline
                                                            treatment of          per lb. body weight
                                                            bacterial enteritis   per day and not
                                                            caused by E. coli     less than 60 mg or
                                                            and bacterial         more than 300 mg
                                                            pneumonia caused by   lasalocid per head
                                                            P. multocida          per day in at least
                                                            organisms             1 pound of feed.
                                                            susceptible to        Daily lasalocid
                                                            chlortetracycline;    intakes in excess
                                                            and for increased     of 200 mg/head/day
                                                            rate of weight gain.  in pasture cattle
                                                                                  have not been shown
                                                                                  to be more
                                                                                  effective than 200
                                                                                  mg lasalocid/head/
                                                                                  day. Do not allow
                                                                                  horses or other
                                                                                  equines access to
                                                                                  feeds containing
                                                                                  lasalocid. No
                                                                                  withdrawal period
                                                                                  is required. A
                                                                                  withdrawal period
                                                                                  has not been
                                                                                  established for
                                                                                  this product in pre-
                                                                                  ruminating calves.
                                                                                  Do not use in
                                                                                  calves to be
                                                                                  processed for veal.
                                                                                  See Sec.
                                                                                  558.311(d) of this
                                                                                  chapter. Lasalocid
                                                                                  as provided by No.
                                                                                  054771 in Sec.
                                                                                  510.600(c) of this
                                                                                  chapter.
(x) 500 to 4,000 g/ton............  .....................  Calves, beef and      Feed continuously        054771
                                                            nonlactating dairy    for not more than 5     069254
                                                            cattle: For the       days to provide 10
                                                            treatment of          mg/lb body weight
                                                            bacterial enteritis   per day. To sponsor
                                                            caused by E. coli     No. 054771 under
                                                            and bacterial         NADA 046-699: 24-
                                                            pneumonia caused by   hour withdrawal
                                                            P. multocida          period. To sponsor
                                                            susceptible to        No. 054771 under
                                                            chlortetracycline.    NADA 048-761 and
                                                                                  No. 069254 under
                                                                                  ANADA 200-510: Zero
                                                                                  withdrawal period.

[[Page 440]]

 
(xi) 500 to 4,000.................  Decoquinate, 12.9 to   Calves, beef and non- Feed at a rate of 1g     054771
                                     90.8.                  lactating dairy       chlortetracycline       069254
                                                            cattle: For the       per 100 lb body
                                                            treatment of          weight/day and 22.7
                                                            bacterial enteritis   mg decoquinate per
                                                            caused by E. coli     100 lb of body
                                                            and bacterial         weight/day for not
                                                            pneumonia caused by   more than 5 days.
                                                            P. multocida          When it is fully
                                                            organisms             consumed, resume
                                                            susceptible to        feeding 22.7 mg
                                                            chlortetracycline;    decoquinate per 100
                                                            and for the           lb of body weight/
                                                            prevention of         day for a total of
                                                            coccidiosis caused    28 days to prevent
                                                            by Eimeria bovis      coccidiosis. A
                                                            and E. zuernii.       withdrawal period
                                                                                  has not been
                                                                                  established for
                                                                                  this product in pre-
                                                                                  ruminating calves.
                                                                                  Do not use in
                                                                                  calves to be
                                                                                  processed for veal.
                                                                                  Do not feed to
                                                                                  animals producing
                                                                                  milk for food.
                                                                                  Decoquinate as
                                                                                  provided by No.
                                                                                  054771 in Sec.
                                                                                  510.600(c) of this
                                                                                  chapter.
(xii) 4,000 to 20,000 g/ton.......  .....................  Calves, beef and      As a top dress,          054771
                                                            nonlactating dairy    varying with body       069254
                                                            cattle: For the       weight and feed
                                                            treatment of          consumption, to
                                                            bacterial enteritis   provide 10 mg/lb
                                                            caused by E. coli     per day. Treat for
                                                            and bacterial         not more than 5
                                                            pneumonia caused by   days. See paragraph
                                                            P. multocida          (d)(3) of this
                                                            organisms             section.
                                                            susceptible to
                                                            chlortetracycline.
(xiii) 4,000 to 20,000 g/ton......  Decoquinate, 90.8 to   Calves, beef and non- Administer as a top      054771
                                     535.7.                 lactating dairy       dress supplement or
                                                            cattle: For the       mix into the daily
                                                            treatment of          ration to provide
                                                            bacterial enteritis   22.7 mg decoquinate
                                                            caused by E. coli     per 100 lb of body
                                                            and bacterial         weight per day and
                                                            pneumonia caused by   1 g
                                                            P. multocida          chlortetracycline
                                                            organisms             per 100 lb body
                                                            susceptible to        weight/day for not
                                                            chlortetracycline;    more than 5 days.
                                                            and for the           When it is fully
                                                            prevention of         consumed, resume
                                                            coccidiosis caused    feeding 22.7 mg
                                                            by E. bovis and E.    decoquinate per 100
                                                            zuernii.              lb of body weight/
                                                                                  day for a total of
                                                                                  28 days to prevent
                                                                                  coccidiosis. A
                                                                                  withdrawal period
                                                                                  has not been
                                                                                  established for
                                                                                  this product in pre-
                                                                                  ruminating calves.
                                                                                  Do not use in
                                                                                  calves to be
                                                                                  processed for veal.
                                                                                  Do not feed to
                                                                                  animals producing
                                                                                  milk for food.
                                                                                  Decoquinate as
                                                                                  provided by No.
                                                                                  054771 in Sec.
                                                                                  510.600(c) of this
                                                                                  chapter.
(xiv) 70 mg/head/day..............  .....................  Growing cattle (over  See paragraph (d)(3)     054771
                                                            400 lb): For          of this section.        066104
                                                            reduction of                                  069254
                                                            incidence of liver
                                                            abscesses.
(xv) 350 mg/head/day..............                         1. Beef cattle: For   Withdrawal periods:      054771
                                                            control of            To sponsor No.          066104
                                                            bacterial pneumonia   054771 under NADAs      069254
                                                            associated with       046-699 and 049-
                                                            shipping fever        287, No. 066104
                                                            complex caused by     under NADA 092-286,
                                                            Pasteurella spp.      and No. 069254
                                                            susceptible to        under NADA 048-480:
                                                            chlortetracycline.    Withdraw 48 hours
                                                                                  prior to slaughter.
                                                                                  To sponsor No.
                                                                                  069254 under NADA
                                                                                  138-935 and ANADA
                                                                                  200-510: Zero
                                                                                  withdrawal period.

[[Page 441]]

 
                                                           2. Beef cattle        Withdrawal periods:      054771
                                                            (under 700 lb): For   To sponsor No.          066104
                                                            control of active     054771 under NADAs      069254
                                                            infection of          046-699 and 049-
                                                            anaplasmosis caused   287, No. 066104
                                                            by A. marginale       under NADA 092-286,
                                                            susceptible to        and No. 069254
                                                            chlortetracycline.    under NADA 048-480:
                                                                                  Withdraw 48 hours
                                                                                  prior to slaughter.
                                                                                  To sponsor No.
                                                                                  054771 under NADA
                                                                                  048-761 and No.
                                                                                  069254 under NADA
                                                                                  138-935 and ANADA
                                                                                  200-510: Zero
                                                                                  withdrawal period.
(xvi) 20 to 350 g/ton.............  .....................  Beef cattle and       Feed to provide          054771
                                                            replacement dairy     chlortetracycline       069254
                                                            heifers: For          at the rate of 350
                                                            control of            mg per head per
                                                            bacterial pneumonia   day. This drug is
                                                            associated with       not approved for
                                                            shipping fever        use in female dairy
                                                            complex caused by     cattle 20 months of
                                                            Pasteurella spp.      age or older,
                                                            susceptible to        including dry dairy
                                                            chlortetracycline..   cows. Use in these
                                                                                  cattle may cause
                                                                                  drug residues in
                                                                                  milk and/or in
                                                                                  calves born to
                                                                                  these cows. A
                                                                                  withdrawal period
                                                                                  has not been
                                                                                  established for
                                                                                  this product in pre-
                                                                                  ruminating calves.
                                                                                  Do not use in
                                                                                  calves to be
                                                                                  processed for veal.
                                                                                  To sponsor No.
                                                                                  054771 under NADA
                                                                                  048-761 and No.
                                                                                  069254 under ANADA
                                                                                  200-510: zero
                                                                                  withdrawal period..
(xvii) 350 mg/head/day............  Laidlomycin, 5.......  Cattle fed in         Feed continuously at     054771
                                                            confinement for       a rate of 30 to 75
                                                            slaughter: For        mg laidlomycin
                                                            control of            propionate
                                                            bacterial pneumonia   potassium per head
                                                            associated with       per day. A
                                                            shipping fever        withdrawal period
                                                            complex caused by     has not been
                                                            Pasteurella spp.      established for
                                                            susceptible to        this product in pre-
                                                            chlortetracycline;    ruminating calves.
                                                            and for increased     Do not use in
                                                            rate of weight and    calves to be
                                                            improved feed         processed for veal.
                                                            efficiency.           See Sec.
                                                                                  558.305(d) of this
                                                                                  chapter.
                                                                                  Laidlomycin as
                                                                                  provided by No.
                                                                                  054771 in Sec.
                                                                                  510.600(c) of this
                                                                                  chapter.
(xviii) 350 mg/head/day...........  Laidlomycin, 5 to 10.  Cattle fed in         Feed continuously at     054771
                                                            confinement for       a rate of 30 to 75
                                                            slaughter: For        mg laidlomycin
                                                            control of            propionate
                                                            bacterial pneumonia   potassium per head
                                                            associated with       per day. A
                                                            shipping fever        withdrawal period
                                                            complex caused by     has not been
                                                            Pasteurella spp.      established for
                                                            susceptible to        this product in pre-
                                                            chlortetracycline;    ruminating calves.
                                                            and for improved      Do not use in
                                                            feed efficiency.      calves to be
                                                                                  processed for veal.
                                                                                  See Sec.
                                                                                  558.305(d) of this
                                                                                  chapter.
                                                                                  Laidlomycin as
                                                                                  provided by No.
                                                                                  054771 in Sec.
                                                                                  510.600(c) of this
                                                                                  chapter.

[[Page 442]]

 
(xix) 25 to 42.2 g/ton to provide   Lasalocid, 25 to 30..  Cattle under 700      Feed continuously in     054771
 350 mg/head/day.                                           pounds fed in         complete feed at a      069254
                                                            confinement for       rate of 350 mg
                                                            slaughter: For        chlortetracycline
                                                            control of active     and not less than
                                                            infection of          250 mg nor more
                                                            anaplasmosis caused   than 360 mg
                                                            by A. marginale       lasalocid per head
                                                            susceptible to        daily. Do not allow
                                                            chlortetracycline;    horses or other
                                                            and for increased     equines access to
                                                            rate of weight gain   feeds containing
                                                            and improved feed     lasalocid. No
                                                            efficiency.           withdrawal period
                                                                                  is required. A
                                                                                  withdrawal period
                                                                                  has not been
                                                                                  established for
                                                                                  this product in pre-
                                                                                  ruminating calves.
                                                                                  Do not use in
                                                                                  calves to be
                                                                                  processed for veal.
                                                                                  See Sec.
                                                                                  558.311(d) of this
                                                                                  chapter. Lasalocid
                                                                                  as provided by No.
                                                                                  054771 in Sec.
                                                                                  510.600(c) of this
                                                                                  chapter.
(xx) 25 to 42.2 g/ton to provide    Lasalocid, 25 to 30..  Cattle fed in         Feed continuously in     054771
 350 mg/head/day.                                           confinement for       complete feed at a      069254
                                                            slaughter: For        rate of 350 mg
                                                            control of            chlortetracycline
                                                            bacterial pneumonia   and not less than
                                                            associated with       250 mg nor more
                                                            shipping fever        than 360 mg
                                                            complex caused by     lasalocid per head
                                                            P. multocida          daily. Do not allow
                                                            organisms             horses or other
                                                            susceptible to        equines access to
                                                            chlortetracycline;    feeds containing
                                                            and for increased     lasalocid. No
                                                            rate of weight gain   withdrawal period
                                                            and improved feed     is required. A
                                                            efficiency.           withdrawal period
                                                                                  has not been
                                                                                  established for
                                                                                  this product in pre-
                                                                                  ruminating calves.
                                                                                  Do not use in
                                                                                  calves to be
                                                                                  processed for veal.
                                                                                  See Sec.
                                                                                  558.311(d) of this
                                                                                  chapter. Lasalocid
                                                                                  as provided by No.
                                                                                  054771 in Sec.
                                                                                  510.600(c) of this
                                                                                  chapter.
(xxi) 25 to 100 g/ton to provide    Lasalocid, 10 to 30..  Cattle under 700      Feed continuously in     054771
 350 mg/head/day.                                           pounds fed in         complete feed at a      069254
                                                            confinement for       rate of 350 mg
                                                            slaughter: For        chlortetracycline
                                                            control of active     and not less than
                                                            infection of          100 mg nor more
                                                            anaplasmosis caused   than 360 mg
                                                            by A. marginale       lasalocid per head
                                                            susceptible to        daily. Do not allow
                                                            chlortetracycline;    horses or other
                                                            and for improved      equines access to
                                                            feed efficiency.      feeds containing
                                                                                  lasalocid. No
                                                                                  withdrawal period
                                                                                  is required. A
                                                                                  withdrawal period
                                                                                  has not been
                                                                                  established for
                                                                                  this product in pre-
                                                                                  ruminating calves.
                                                                                  Do not use in
                                                                                  calves to be
                                                                                  processed for veal.
                                                                                  See Sec.
                                                                                  558.311(d) of this
                                                                                  chapter. Lasalocid
                                                                                  as provided by No.
                                                                                  054771 in Sec.
                                                                                  510.600(c) of this
                                                                                  chapter.

[[Page 443]]

 
(xxii) 25 to 100 g/ton to provide   Lasalocid, 10 to 30..  Cattle fed in         Feed continuously in     054771
 350 mg/head/day.                                           confinement for       complete feed at a      069254
                                                            slaughter: For        rate of 350 mg
                                                            control of            chlortetracycline
                                                            bacterial pneumonia   and not less than
                                                            associated with       100 mg nor more
                                                            shipping fever        than 360 mg
                                                            complex caused by     lasalocid per head
                                                            P. multocida          daily. Do not allow
                                                            organisms             horses or other
                                                            susceptible to        equines access to
                                                            chlortetracycline;    feeds containing
                                                            and for improved      lasalocid. No
                                                            feed efficiency.      withdrawal period
                                                                                  is required. A
                                                                                  withdrawal period
                                                                                  has not been
                                                                                  established for
                                                                                  this product in pre-
                                                                                  ruminating calves.
                                                                                  Do not use in
                                                                                  calves to be
                                                                                  processed for veal.
                                                                                  See Sec.
                                                                                  558.311(d) of this
                                                                                  chapter. Lasalocid
                                                                                  as provided by No.
                                                                                  054771 in Sec.
                                                                                  510.600(c) of this
                                                                                  chapter.
(xxiii) 25 to 700 to provide 350    Lasalocid, 30 to 600.  Pasture cattle        Feed continuously on     054771
 mg/head/day.                                               (slaughter,           a hand-fed basis at     069254
                                                            stocker, feeder       a rate of 350 mg
                                                            cattle, dairy and     chlortetracycline
                                                            beef replacement      and not less than
                                                            heifers): For         60 mg nor more than
                                                            control of            300 mg lasalocid
                                                            bacterial pneumonia   per head per day in
                                                            associated with       at least 1 pound of
                                                            shipping fever        feed. Daily
                                                            complex caused by     lasalocid intakes
                                                            P. multocida          in excess of 200 mg/
                                                            organisms             head/day in pasture
                                                            susceptible to        cattle have not
                                                            chlortetracycline;    been shown to be
                                                            and for increased     more effective than
                                                            rate of weight gain.  200 mg lasalocid/
                                                                                  head/day. Do not
                                                                                  allow horses or
                                                                                  other equines
                                                                                  access to feeds
                                                                                  containing
                                                                                  lasalocid. No
                                                                                  withdrawal period
                                                                                  is required. A
                                                                                  withdrawal period
                                                                                  has not been
                                                                                  established for
                                                                                  this product in pre-
                                                                                  ruminating calves.
                                                                                  Do not use in
                                                                                  calves to be
                                                                                  processed for veal.
                                                                                  See Sec.
                                                                                  558.311(d) of this
                                                                                  chapter. Lasalocid
                                                                                  as provided by No.
                                                                                  054771 in Sec.
                                                                                  510.600(c) of this
                                                                                  chapter.
(xxiv) 25 to 700 to provide 350 mg/ Lasalocid, 30 to 600.  Pasture cattle        Feed continuously on     054771
 head/day.                                                  (slaughter,           a hand-fed basis at     069254
                                                            stocker, feeder       a rate of 350 mg
                                                            cattle, beef          chlortetracycline
                                                            replacement           and not less than
                                                            heifers) under 700    60 mg nor more than
                                                            pounds: For control   300 mg lasalocid
                                                            of active infection   per head per day in
                                                            of anaplasmosis       at least 1 pound of
                                                            caused by A.          feed. Daily
                                                            marginale             lasalocid intakes
                                                            susceptible to        in excess of 200 mg/
                                                            chlortetracycline;    head/day in pasture
                                                            and for increased     cattle have not
                                                            rate of weight gain.  been shown to be
                                                                                  more effective than
                                                                                  200 mg lasalocid/
                                                                                  head/day. Do not
                                                                                  allow horses or
                                                                                  other equines
                                                                                  access to feeds
                                                                                  containing
                                                                                  lasalocid. No
                                                                                  withdrawal period
                                                                                  is required. A
                                                                                  withdrawal period
                                                                                  has not been
                                                                                  established for
                                                                                  this product in pre-
                                                                                  ruminating calves.
                                                                                  Do not use in
                                                                                  calves to be
                                                                                  processed for veal.
                                                                                  See Sec.
                                                                                  558.311(d) of this
                                                                                  chapter. Lasalocid
                                                                                  as provided by No.
                                                                                  054771 in Sec.
                                                                                  510.600(c) of this
                                                                                  chapter.

[[Page 444]]

 
(xxv) 25 to 2,800 to provide 350    Lasalocid, 30 to       Beef cattle weighing  Hand feed                054771
 mg/head/day.                        181.8.                 under 700 pounds:     continuously at a       069254
                                                            For control of        rate of 350 mg
                                                            active infection of   chlortetracycline
                                                            anaplasmosis caused   and 1 mg lasalocid
                                                            by Anaplasma          per 2.2 lb. body
                                                            marginale             weight daily to
                                                            susceptible to        cattle with a
                                                            chlortetracycline;    maximum of 360 mg
                                                            and for the control   of lasalocid per
                                                            of coccidiosis        head per day. Do
                                                            caused by Eimeria     not allow horses or
                                                            bovis and E.          other equines
                                                            zuernii.              access to feeds
                                                                                  containing
                                                                                  lasalocid. No
                                                                                  withdrawal period
                                                                                  is required. A
                                                                                  withdrawal period
                                                                                  has not been
                                                                                  established for
                                                                                  this product in pre-
                                                                                  ruminating calves.
                                                                                  Do not use in
                                                                                  calves to be
                                                                                  processed for veal.
                                                                                  See Sec.
                                                                                  558.311(d) of this
                                                                                  chapter.
                                                                                  Chlortetracycline
                                                                                  and lasalocid as
                                                                                  provided by No.
                                                                                  054771 in Sec.
                                                                                  510.600(c) of this
                                                                                  chapter.
(xxvi) 25 to 2,800 to provide 350   Lasalocid, 30 to       Beef cattle weighing  Hand feed                054771
 mg/head/day.                        181.8.                 up to 800 pounds:     continuously at a       069254
                                                            For control of        rate of 350 mg
                                                            bacterial pneumonia   chlortetracycline
                                                            associated with       and 1 mg lasalocid
                                                            shipping fever        per 2.2 lb. body
                                                            complex caused by     weight daily to
                                                            Pasteurella spp.      cattle with a
                                                            susceptible to        maximum of 360 mg
                                                            chlortetracycline;    of lasalocid per
                                                            and for the control   head per day. Do
                                                            of coccidiosis        not allow horses or
                                                            caused by E. bovis    other equines
                                                            and E. zuernii.       access to feeds
                                                                                  containing
                                                                                  lasalocid. No
                                                                                  withdrawal period
                                                                                  is required. A
                                                                                  withdrawal period
                                                                                  has not been
                                                                                  established for
                                                                                  this product in pre-
                                                                                  ruminating calves.
                                                                                  Do not use in
                                                                                  calves to be
                                                                                  processed for veal.
                                                                                  See Sec.
                                                                                  558.311(d) of this
                                                                                  chapter. Lasalocid
                                                                                  as provided by No.
                                                                                  054771 in Sec.
                                                                                  510.600(c) of this
                                                                                  chapter.
(xxvii) 500 to 4,000 to provide 10  Lasalocid, 30 to       Cattle weighing up    Hand feed                054771
 mg/head/day.                        181.8.                 to 800 pounds: For    continuously for        069254
                                                            the treatment of      not more than 5
                                                            bacterial enteritis   days at a rate of
                                                            caused by E. coli     10 mg
                                                            and bacterial         chlortetracycline
                                                            pneumonia caused by   and 1 mg lasalocid
                                                            P. multocida          per 2.2 lb. body
                                                            susceptible to        weight daily to
                                                            chlortetracycline;    cattle with a
                                                            and for the control   maximum of 360 mg
                                                            of coccidiosis        of lasalocid per
                                                            caused by Eimeria     head per day. Do
                                                            bovis and E.          not allow horses or
                                                            zuernii.              other equines
                                                                                  access to feeds
                                                                                  containing
                                                                                  lasalocid. No
                                                                                  withdrawal period
                                                                                  is required. A
                                                                                  withdrawal period
                                                                                  has not been
                                                                                  established for
                                                                                  this product in pre-
                                                                                  ruminating calves.
                                                                                  Do not use in
                                                                                  calves to be
                                                                                  processed for veal.
                                                                                  See Sec.
                                                                                  558.311(d) of this
                                                                                  chapter. Lasalocid
                                                                                  as provided by No.
                                                                                  054771 in Sec.
                                                                                  510.600(c) of this
                                                                                  chapter.
----------------------------------------------------------------------------------------------------------------

    (5) Minor species. It is used as follows:

[[Page 445]]



----------------------------------------------------------------------------------------------------------------
     Chlortetracycline amount            Indications for use                Limitations               Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 80 mg/head/day................  Breeding sheep; reducing the   .............................          054771
                                     incidence of (vibrionic)                                             066104
                                     abortion caused by                                                   069254
                                     Campylobacter fetus
                                     infection susceptible to
                                     chlortetracycline.
(ii) 200 to 400 g/ton.............  Ducks: For the control and     Feed in complete ration to      054771 069254
                                     treatment of fowl cholera      provide from 8 to 28 mg/lb
                                     caused by Pasteurella          of body weight per day,
                                     multocida susceptible to       depending upon age and
                                     chlortetracycline.             severity of disease, for not
                                                                    more than 21 days. Do not
                                                                    feed to ducks producing eggs
                                                                    for human consumption.
(iii) 10 mg/g of finished feed      Psittacine birds (cockatoos,   Feed continuously for 45        054771 069254
 daily.                              macaws, and parrots)           days. Each bird should
                                     suspected or known to be       consume daily an amount of
                                     infected with psittacosis      medicated feed equal to one
                                     caused by Chlamydia psittaci   fifth of its body weight.
                                     sensitive to                   See paragraph (d)(5) of this
                                     chlortetracycline.             section.
----------------------------------------------------------------------------------------------------------------

    (6) It is used as a free-choice, loose mineral Type C feed as 
follows:
    (i) Specifications.

------------------------------------------------------------------------
                                                         International
            Ingredient                   Percent            feed No.
------------------------------------------------------------------------
Dicalcium Phosphate...............              46.20           6-26-335
Sodium Chloride (Salt)............              15.00           6-04-152
Magnesium Oxide...................              10.67           6-02-756
Cottonseed Meal...................              10.00           5-01-625
Trace Mineral/Vitamin Premix \1\..               3.80
Calcium Carbonate.................               3.50           6-01-069
Dried Cane Molasses...............               3.00           4-04-695
Potassium Chloride................               2.00           6-03-755
Mineral Oil.......................               2.00           8-03-123
Iron Oxide........................               0.50           6-02-431
Chlortetracycline Type A medicated               3.33
 article (90 gram/lb).............
------------------------------------------------------------------------
\1\ Content of vitamin and trace mineral premixes may be varied.
  However, they should be comparable to those used for other free-choice
  feeds. Formulation modifications require FDA approval prior to
  marketing. Selenium must comply with 21 CFR 573.920. Ethylenediamine
  dihydroiodide (EDDI) should comply with FDA Compliance Policy Guides
  Sec. 651.100 (CPG 7125.18).

    (ii) Amount. 6,000 grams per ton.
    (iii) Indications for use. Beef and nonlactating dairy cattle: As an 
aid in the control of active infection of anaplasmosis caused by 
Anaplasma marginale susceptible to chlortetracycline.
    (iv) Limitations. Feed continuously on a free-choice basis at a rate 
of 0.5 to 2.0 mg chlortetracycline per pound of body weight per day.
    (v) Sponsors. See Nos. 054771 and 069254 in Sec. 510.600(c) of this 
chapter.

[81 FR 94995, Dec. 27, 2016, as amended at 82 FR 21691, May 10, 2017; 82 
FR 43485, Sept. 18, 2017; 83 FR 13636, Mar. 30, 2018; 83 FR 14588, Apr. 
5, 2018; 83 FR 48947, Sept. 28, 2018; 83 FR 64741, Dec. 18, 2018; 84 FR 
8975, Mar. 13, 2019; 84 FR 39185, Aug. 9, 2019; 86 FR 13189, Mar. 8, 
2021; 86 FR 14822, Mar. 19, 2021; 86 FR 17064, Apr. 1, 2021]



Sec. 558.140  Chlortetracycline and sulfamethazine.

    (a) Specifications. Type A medicated articles containing:
    (1) 35 grams (g) per pound (/lb) each, chlortetracycline and 
sulfamethazine.
    (2) 40 g/lb each, chlortetracycline and sulfamethazine.
    (b) Sponsors. See sponsors in Sec. 510.600(c) of this chapter as 
follows:
    (1) No. 054771 for use of product described in paragraph (a)(1) as 
in paragraph (e)(1) of this section.
    (2) No. 069254 for use of product described in paragraph (a)(1) as 
in paragraph (e)(1)(i) of this section.
    (3) Nos. 054771 and 069254 for use of product described in paragraph 
(a)(2) as in paragraph (e)(2) of this section.
    (c) Related tolerances. See Sec. Sec. 556.150 and 556.670 of this 
chapter.
    (d) Special considerations. (1) Federal law restricts medicated feed 
containing this veterinary feed directive (VFD) drug to use by or on the 
order of a licensed veterinarian. See Sec. 558.6 for additional 
requirements.
    (2) The expiration date of VFDs for chlortetracycline and 
sulfamethazine medicated feeds must not exceed 6 months from the date of 
issuance. VFDs for chlortetracycline and sulfamethazine shall not be 
refilled.

[[Page 446]]

    (e) Conditions of use--(1) Cattle--

----------------------------------------------------------------------------------------------------------------
 Chlortetracycline
and sulfamethazine   Combination in       Indications for use                Limitations               Sponsors
    amount each         grams/ton
----------------------------------------------------------------------------------------------------------------
(i) To provide 350  ................  Beef cattle: As an aid in   Feed for 28 days. Withdraw 7 days       054771
 milligrams per                        the maintenance of weight   prior to slaughter. A withdrawal       069254
 head per day.                         gains in the presence of    period has not been established
                                       respiratory disease such    for this product in pre-
                                       as shipping fever.          ruminating calves. Do not use in
                                                                   calves to be processed for veal.
(ii) 35 to 105 g/   Lasalocid, 10 to  Beef steers and heifers     Feed continuously for 28 days to        054771
 ton, each.          30.               fed in confinement for      provide 350 mg
                                       slaughter: As an aid in     chlortetracycline, 350 mg
                                       the maintenance of weight   sulfamethazine, and 100 to 300
                                       gains in the presence of    mg lasalocid per head per day.
                                       respiratory disease such    Do not allow horses or other
                                       as shipping fever, and      equines access to Type C feeds
                                       for improved feed           containing lasalocid as
                                       efficiency.                 ingestion may be fatal. Safety
                                                                   of lasalocid for use in
                                                                   unapproved species has not been
                                                                   established. Withdraw 7 days
                                                                   prior to slaughter. A withdrawal
                                                                   period has not been established
                                                                   for this product in pre-
                                                                   ruminating calves. Do not use in
                                                                   calves to be processed for veal.
                                                                   Lasalocid as provided by No.
                                                                   054771 in Sec. 510.600(c) of
                                                                   this chapter.
(iii) 35 to 42.2 g/ Lasalocid, 25 to  Beef steers and heifers     Feed continuously for 28 days to        054771
 ton, each.          30.               fed in confinement for      provide 350 mg
                                       slaughter: As an aid in     chlortetracycline, 350 mg
                                       the maintenance of weight   sulfamethazine, and 250 to 300
                                       gains in the presence of    mg lasalocid per head per day.
                                       respiratory disease such    Do not allow horses or other
                                       as shipping fever, and      equines access to Type C feeds
                                       for improved feed           containing lasalocid as
                                       efficiency and increased    ingestion may be fatal. Safety
                                       rate of weight gain.        of lasalocid for use in
                                                                   unapproved species has not been
                                                                   established. Withdraw 7 days
                                                                   prior to slaughter. A withdrawal
                                                                   period has not been established
                                                                   for this product in pre-
                                                                   ruminating calves. Do not use in
                                                                   calves to be processed for veal.
                                                                   Lasalocid as provided by No.
                                                                   054771 in Sec. 510.600(c) of
                                                                   this chapter.

[[Page 447]]

 
(iv) 35 to 700 g/   Lasalocid, 30 to  Beef cattle up to 800 lb:   Hand feed continuously for 28           054771
 ton, each.          181.8.            As an aid in the            days to provide 350 mg
                                       maintenance of weight       chlortetracycline, 350 mg
                                       gains in the presence of    sulfamethazine, and 1 mg
                                       respiratory disease such    lasalocid per 2.2 lb body weight
                                       as shipping fever, and      per day up to a maximum of 360
                                       for control of              mg lasalocid per head per day.
                                       coccidiosis caused by       Do not allow horses or other
                                       Eimeria bovis and E.        equines access to Type C feeds
                                       zuernii.                    containing lasalocid as
                                                                   ingestion may be fatal. Safety
                                                                   of lasalocid for use in
                                                                   unapproved species has not been
                                                                   established. Withdraw 7 days
                                                                   prior to slaughter. A withdrawal
                                                                   period has not been established
                                                                   for this product in pre-
                                                                   ruminating calves. Do not use in
                                                                   calves to be processed for veal.
                                                                   Lasalocid as provided by No.
                                                                   054771 in Sec. 510.600(c) of
                                                                   this chapter.
----------------------------------------------------------------------------------------------------------------

    (2) Swine--

----------------------------------------------------------------------------------------------------------------
   Chlortetracycline and sulfamethazine
                  amount                       Indications for use              Limitations            Sponsors
----------------------------------------------------------------------------------------------------------------
(i) 100 g/ton of feed each,                Swine: For reduction of the  Feed as the sole ration.          054771
 chlortetracycline and sulfamethazine.      incidence of cervical        Withdraw 15 days prior to        069254
                                            abscesses; treatment of      slaughter.
                                            bacterial swine enteritis
                                            (salmonellosis or necrotic
                                            enteritis caused by
                                            Salmonella choleraesuis
                                            and vibrionic dysentery);
                                            prevention of these
                                            diseases during times of
                                            stress; and maintenance of
                                            weight gains in the
                                            presence of atrophic
                                            rhinitis.
(ii) [Reserved]
----------------------------------------------------------------------------------------------------------------


[79 FR 37622, July 2, 2014, as amended at 80 FR 13231, Mar. 13, 2015; 81 
FR 63054, Sept. 14, 2016; 81 FR 95004, Dec. 27, 2016; 82 FR 21691, May 
10, 2017; 84 FR 12495, Apr. 2, 2019; 86 FR 13189, Mar. 8, 2021; 86 FR 
14822, Mar. 19, 2021]



Sec. 558.175  Clopidol.

    (a) Specifications. Type A medicated article containing 25 percent 
clopidol.
    (b) Sponsor. See No. 016592 in Sec. 510.600(c) of this chapter.
    (c) Related tolerances. See Sec. 556.160 of this chapter.
    (d) Conditions of use--(1) Chickens--

[[Page 448]]



----------------------------------------------------------------------------------------------------------------
                                      Combination in
    Clopidol in  grams per ton        grams per ton       Indications for use       Limitations        Sponsors
----------------------------------------------------------------------------------------------------------------
(i) 113.5........................  ...................  Broiler chickens and    Do not feed to            016592
                                                         re-placement chickens   chickens over 16
                                                         intended for use as     weeks of age.
                                                         caged layers: As an
                                                         aid in the prevention
                                                         of coccidiosis caused
                                                         by Eimeria tenella,
                                                         E. necatrix, E.
                                                         acervulina, E.
                                                         maxima, E. brunetti,
                                                         and E. mivati..
(ii) 113.5.......................  Bacitracin           Broiler chickens: As    Feed continuously         016592
                                    methylenedisalicyl   an aid in the           as the sole ration
                                    ate, 4 to 50.        prevention of           from the time
                                                         coccidiosis caused by   chicks are placed
                                                         Eimeria tenella, E.     in floor pens
                                                         necatrix, E.            until slaughter.
                                                         acervulina, E.          Do not feed to
                                                         maxima, E. brunetti,    chickens over 16
                                                         and E. mivati, and      weeks of age;
                                                         for increased rate of   bacitracin
                                                         weight gain..           methylenedisalicyl
                                                                                 ate as provided by
                                                                                 No. 054771 in Sec.
                                                                                   510.600(c) of
                                                                                 this chapter.
(iii) 113.5......................  Bacitracin zinc, 5   Broiler chickens: As    Feed continuously         054771
                                    to 25.               an aid in the           as sole ration;          016592
                                                         prevention of           bacitracin zinc as
                                                         coccidiosis caused by   provided by No.
                                                         Eimeria tenella, E.     054771 in Sec.
                                                         necatrix, E.            510.600(c) of this
                                                         acervulina, E.          chapter.
                                                         maxima, E. brunetti,
                                                         and E. mivati, and
                                                         for increased rate of
                                                         weight gain and
                                                         improved feed
                                                         efficiency..
(iv) 113.5.......................  Bambermycins, 1 to   Broiler chickens: As    Feed continuously         016592
                                    2.                   an aid in prevention    as the sole
                                                         of coccidiosis caused   ration. Do not
                                                         by Eimeria tenella,     feed to chickens
                                                         E. necatrix, E.         over 16 weeks of
                                                         acervulina, E.          age.
                                                         maxima, E. brunetti,
                                                         and E. mivati; and
                                                         for increased rate of
                                                         weight gain and
                                                         improved feed
                                                         efficiency..
(v) 227..........................  ...................  Broiler and             Feed continuously         016592
                                                         replacement chickens    as the sole
                                                         intended for use as     ration; feed up to
                                                         caged layers: As an     16 weeks of age if
                                                         aid in the prevention   intended for use
                                                         of coccidiosis caused   as caged layers;
                                                         by Eimeria tenella,     withdraw 5 days
                                                         E. necatrix, E.         before slaughter
                                                         acervulina, E.          if given at the
                                                         maxima, E. brunetti,    level of 0.025
                                                         and E. mivati..         percent in feed or
                                                                                 reduce level to
                                                                                 0.0125 percent 5
                                                                                 days before
                                                                                 slaughter.
(vi) 227.........................  Bambermycins, 1 to   Broiler chickens: As    Feed continuously         016592
                                    2.                   an aid in prevention    as sole ration
                                                         of coccidiosis caused   until 5 days
                                                         by Eimeria tenella,     before slaughter.
                                                         E. necatrix, E.         Withdraw 5 days
                                                         acervulina, E.          before slaughter
                                                         maxima, E. brunetti,    or feed 113.5 g/
                                                         and E. mivati; and      ton clopidol and 1
                                                         for increased rate of   to 2 g/ton
                                                         weight gain and         bambermycins
                                                         improved feed           during those 5
                                                         efficiency..            days before
                                                                                 slaughter. Do not
                                                                                 feed to chickens
                                                                                 over 16 weeks of
                                                                                 age.
----------------------------------------------------------------------------------------------------------------

    (2) Turkeys--

----------------------------------------------------------------------------------------------------------------
                                      Combination in
    Clopidol in  grams per ton        grams per ton       Indications for use       Limitations        Sponsors
----------------------------------------------------------------------------------------------------------------
(i) 113.5 or 227.................  ...................  Turkeys: As an aid in   For turkeys grown         016592
                                                         the prevention of       for meat purposes
                                                         leucocytozoonosis       only; feed
                                                         caused by               continuously as
                                                         Leucocytozoon smithi..  the sole ration at
                                                                                 0.0125 or 0.025
                                                                                 percent clopidol
                                                                                 depending on
                                                                                 management
                                                                                 practices, degree
                                                                                 of exposure, and
                                                                                 amount of feed
                                                                                 eaten; withdraw 5
                                                                                 days before
                                                                                 slaughter.
(ii) [Reserved]
----------------------------------------------------------------------------------------------------------------

    (3) Combinations. Clopidol may also be used in combination with:
    (i) Chlortetracycline as in Sec. 558.128.

[[Page 449]]

    (ii) Lincomycin as in Sec. 558.325.

[68 FR 17882, Apr. 14, 2003, as amended at 72 FR 60551, Oct. 25, 2007; 
74 FR 61028, Nov. 23, 2009; 79 FR 10965, 10982, Feb. 27, 2014; 79 FR 
13545, Mar. 11, 2014; 81 FR 17609, Mar. 30, 2016; 81 FR 95004, Dec. 27, 
2016; 84 FR 12495, Apr. 2, 2019; 86 FR 14822, Mar. 19, 2021]



Sec. 558.185  Coumaphos.

    (a) Specifications. Type A medicated articles containing 1.12, 2.0, 
11.2, or 50 percent coumaphos.
    (b) Sponsor. See No. 058198 in Sec. 510.600(c) of this chapter.
    (c) Related tolerances. See Sec. 556.168 of this chapter.
    (d) Special considerations. (1) Labeling shall bear the following 
warning: The active ingredient coumaphos is a cholinesterase inhibitor. 
Do not use this product on animals simultaneously or within a few days 
before or after treatment with, or exposure to, cholinesterase-
inhibiting drugs, pesticides, or chemicals.
    (2) See Sec. 500.25 of this chapter.
    (e) Conditions of use in laying chickens.

----------------------------------------------------------------------------------------------------------------
        Coumaphos in grams per ton             Indications for use              Limitations            Sponsor
----------------------------------------------------------------------------------------------------------------
(1) 27.2 (0.003 percent).................  Laying chickens: For         Feed continuously as the          058198
                                            control of capillary worm    sole ration for 14 days.
                                            (Capillaria obsignata) and   If reinfection occurs,
                                            as an aid in control of      treatment may be repeated,
                                            common round worm            but not sooner than 3
                                            (Ascaridia galli) and        weeks after the end of the
                                            cecal worm (Heterakis        previous treatment. Do not
                                            gallinae).                   feed to chickens within 10
                                                                         days of vaccination or
                                                                         other conditions of
                                                                         stress..
(2) 36.3 (0.004 percent).................  Replacement pullets: For     Feed continuously as the          058198
                                            control of capillary worm    sole ration for from 10 to
                                            (Capillaria obsignata) and   14 days. Do not feed to
                                            as an aid in control of      chickens under 8 weeks of
                                            common round worm            age or within 10 days of
                                            (Ascaridia galli) and        vaccination or other
                                            cecal worm (Heterakis        conditions of stress. If
                                            gallinae).                   birds are maintained on
                                                                         contaminated litter or
                                                                         exposed to infected birds,
                                                                         a second 10- to 14-day
                                                                         treatment is recommended,
                                                                         but not sooner than 3
                                                                         weeks after the end of the
                                                                         previous treatment. If
                                                                         reinfection occurs after
                                                                         production begins, repeat
                                                                         treatment as recommended
                                                                         for laying flocks..
----------------------------------------------------------------------------------------------------------------


[86 FR 14822, Mar. 19, 2021]



Sec. 558.195  Decoquinate.

    (a) Specifications. Type A medicated article containing 6 percent 
decoquinate.
    (b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
    (c) Related tolerances. See Sec. 556.170 of this chapter.
    (d) Special considerations. (1) Bentonite should not be used in 
decoquinate feeds.
    (2) Type A medicated articles may be used to manufacture dry or 
liquid Type B cattle (including veal calf), sheep, and goat feeds as in 
paragraphs (e)(2) and (e)(3) of this section.
    (3) Type C cattle feeds may be manufactured from decoquinate liquid 
Type B feeds having a pH between 5.0 to 6.5 and containing a suspending 
agent to maintain a viscosity of not less than 500 centipoises.
    (e) Conditions of use. It is used as follows:
    (1) Chickens--

----------------------------------------------------------------------------------------------------------------
                                      Combination in
    Decoquinate in  grams/ton           grams/ton         Indications for use       Limitations        Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 27.2.........................                       Broiler chickens: For   Do not feed to            054771
                                                         prevention of           laying hens
                                                         coccidiosis caused by   producing eggs for
                                                         Eimeria tenella, E.     human consumption.
                                                         necatrix, E. mivati,
                                                         E. acervulina, E.
                                                         maxima, and E.
                                                         brunetti.

[[Page 450]]

 
(ii) 27.2........................  Bacitracin           Broiler chickens: For   Feed continuously         054771
                                    methylenedisalicyl   prevention of           as sole ration; do
                                    ate, 4 to 50.        coccidiosis caused by   not feed to laying
                                                         Eimeria tenella, E.     chickens.
                                                         necatrix, E. mivati,    Bacitracin
                                                         E. acervulina, E.       methylenedisalicyl
                                                         maxima, and E.          ate as provided by
                                                         brunetti; and for       No. 054771 in Sec.
                                                         increased rate of         510.600(c) of
                                                         weight gain and         this chapter.
                                                         improved feed
                                                         efficiency.
(iii) 27.2.......................  Bacitracin zinc, 10  Broiler chickens: For   Feed continuously         054771
                                    to 50.               prevention of           as sole ration; do
                                                         coccidiosis caused by   not feed to laying
                                                         Eimeria tenella, E.     chickens.
                                                         necatrix, E. mivati,    Bacitracin zinc as
                                                         E. acervulina, E.       provided by No.
                                                         maxima, and E.          054771 in Sec.
                                                         brunetti.               510.600(c) of this
                                                                                 chapter.
----------------------------------------------------------------------------------------------------------------

    (2) Cattle--

----------------------------------------------------------------------------------------------------------------
                                      Combination in
    Decoquinate in  grams/ton           grams/ton         Indications for use       Limitations        Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 12.9 to 90.8.................                       Cattle (including       Feed Type C feed or       054771
                                                         ruminating and          milk replacer to
                                                         nonruminating calves    provide 22.7
                                                         and veal calves): For   milligrams (mg)
                                                         prevention of           per 100 pounds
                                                         coccidiosis caused by   (lb) of body
                                                         Eimeria bovis and E.    weight (0.5 mg/kg)
                                                         zuernii.                per day. Feed at
                                                                                 least 28 days
                                                                                 during periods of
                                                                                 exposure to
                                                                                 coccidiosis or
                                                                                 when it is likely
                                                                                 to be a hazard. Do
                                                                                 not feed to cows
                                                                                 producing milk for
                                                                                 human consumption.
                                                                                 See paragraph
                                                                                 (d)(3) of this
                                                                                 section.
(ii) 12.9 to 90.8................  Monensin, 5 to 30..  Cattle fed in           Feed continuously        016592,
                                                         confinement for         as the sole ration       054771
                                                         slaughter: For          to provide 22.7 mg
                                                         prevention of           of decoquinate per
                                                         coccidiosis caused by   100 lb of body
                                                         Eimeria bovis and E.    weight per day and
                                                         zuernii; and for        50 to 360 mg of
                                                         improved feed           monensin per head
                                                         efficiency.             per day. Feed at
                                                                                 least 28 days
                                                                                 during period of
                                                                                 exposure to
                                                                                 coccidiosis or
                                                                                 when it is likely
                                                                                 to be a hazard. Do
                                                                                 not feed to
                                                                                 animals producing
                                                                                 milk for food. Do
                                                                                 not feed to
                                                                                 lactating dairy
                                                                                 cattle. Also see
                                                                                 paragraph (d)(1)
                                                                                 of this section
                                                                                 and Sec.
                                                                                 558.355(d)(9)(i).
                                                                                 Monensin as
                                                                                 provided by No.
                                                                                 016592 or 058198
                                                                                 in Sec.
                                                                                 510.600(c) of this
                                                                                 chapter.
(iii) 90.9 to 535.7..............                       Cattle (including       Feed Type C               054771
                                                         ruminating and          medicated feed
                                                         nonruminating calves    supplements as a
                                                         and veal calves): For   top dress or mix
                                                         prevention of           into the daily
                                                         coccidiosis caused by   ration to provide
                                                         Eimeria bovis and E.    22.7 mg per 100 lb
                                                         zuernii.                of body weight
                                                                                 (0.5 mg/kg) per
                                                                                 day. Feed at least
                                                                                 28 days during
                                                                                 periods of
                                                                                 exposure to
                                                                                 coccidiosis or
                                                                                 when it is likely
                                                                                 to be a hazard. Do
                                                                                 not feed to cows
                                                                                 producing milk for
                                                                                 food. See
                                                                                 paragraph (d)(3)
                                                                                 of this section.
----------------------------------------------------------------------------------------------------------------

    (3) Minor species--

[[Page 451]]



----------------------------------------------------------------------------------------------------------------
                                      Combination in
     Decoquinate in grams/ton           grams/ton         Indications for use       Limitations        Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 12.9 to 90.8.................  ...................  1. Young sheep: For     Feed Type C feed or       054771
                                                         the prevention of       milk replacer at a
                                                         coccidiosis caused by   rate to provide
                                                         Eimeria ovinoidalis,    22.7 mg per 100 lb
                                                         E. crandallis, E.       of body weight
                                                         parva, and E.           (0.5 mg per kg)
                                                         bakuensis.              per day; feed for
                                                                                 at least 28 days
                                                                                 during periods of
                                                                                 exposure to
                                                                                 coccidiosis or
                                                                                 when it is likely
                                                                                 to be a hazard. Do
                                                                                 not feed to sheep
                                                                                 producing milk for
                                                                                 human consumption.
                                   ...................  2. Young goats: For     Feed Type C feed or
                                                         the prevention of       milk replacer at a
                                                         coccidiosis caused by   rate to provide
                                                         Eimeria christenseni    22.7 mg per 100 lb
                                                         and E.                  of body weight
                                                         ninakohlyakimovae.      (0.5 mg per kg)
                                                                                 per day; feed for
                                                                                 at least 28 days
                                                                                 during periods of
                                                                                 exposure to
                                                                                 coccidiosis or
                                                                                 when it is likely
                                                                                 to be a hazard. Do
                                                                                 not feed to goats
                                                                                 producing milk for
                                                                                 human consumption.
(ii) 90.9 to 535.7...............  ...................  1. Young sheep: For     Feed Type C               054771
                                                         the prevention of       medicated feed
                                                         coccidiosis caused by   supplements as a
                                                         Eimeria ovinoidalis,    top dress or mix
                                                         E. crandallis, E.       into the daily
                                                         parva, and E.           ration to provide
                                                         bakuensis.              22.7 mg per 100 lb
                                                                                 of body weight
                                                                                 (0.5 mg per kg)
                                                                                 per day; feed for
                                                                                 at least 28 days
                                                                                 during periods of
                                                                                 exposure to
                                                                                 coccidiosis or
                                                                                 when it is likely
                                                                                 to be a hazard. Do
                                                                                 not feed to sheep
                                                                                 producing milk for
                                                                                 human consumption.
                                   ...................  2. Young goats: For     Feed Type C          ...........
                                                         the prevention of       medicated feed
                                                         coccidiosis caused by   supplements as a
                                                         Eimeria christenseni    top dress or mix
                                                         and E.                  into the daily
                                                         ninakohlyakimovae.      ration to provide
                                                                                 22.7 mg per 100 lb
                                                                                 of body weight
                                                                                 (0.5 mg per kg)
                                                                                 per day; feed for
                                                                                 at least 28 days
                                                                                 during periods of
                                                                                 exposure to
                                                                                 coccidiosis or
                                                                                 when it is likely
                                                                                 to be a hazard. Do
                                                                                 not feed to goats
                                                                                 producing milk for
                                                                                 human consumption.
----------------------------------------------------------------------------------------------------------------

    (4) Decoquinate may also be used in combination with:
    (i)-(ii) [Reserved]
    (iii) Chlortetracycline as in Sec. 558.128.
    (iv) Lincomycin as in Sec. 558.325.

[67 FR 72370, Dec. 5, 2002; 68 FR 15372, Mar. 31, 2003; 69 FR 26499, May 
13, 2004; 69 FR 52816, Aug. 30, 2004; 69 FR 62407, Oct. 26, 2004; 69 FR 
67264, Nov. 17, 2004; 70 FR 2567, Jan. 14, 2005; 78 FR 25183, Apr. 30, 
2013; 79 FR 10982, Feb. 27, 2014; 79 FR 13545, Mar. 11, 2014; 79 FR 
17860, Mar. 31, 2014; 80 FR 13231, Mar. 13, 2015; 81 FR 17609, Mar. 30, 
2016; 81 FR 22525, Apr. 18, 2016; 81 FR 67152, Sept. 30, 2016; 81 FR 
95004, Dec. 27, 2016; 83 FR 48947, Sept. 28, 2018; 84 FR 12496, Apr. 2, 
2019; 85 FR 18121, Apr. 1, 2020; 86 FR 14822, Mar. 19, 2021]



Sec. 558.198  Dichlorvos.

    (a) Specifications. Each pound of Type A medicated article 
containing 3.1 or 9.6 percent dichlorvos.
    (b) Sponsor. See No. 054628 in Sec. 510.600(c) of this chapter.
    (c) Related tolerances. See Sec. 556.180 of this chapter.
    (d) Special considerations. (1) Dichlorvos is to be included in meal 
or mash or mixed with feed in crumble form only after the crumble feed 
has been manufactured. Do not mix in feeds to be pelleted nor with 
pelleted feed. Do not soak the feed or administer as wet mash. Feed must 
be dry when administered. Do not use in animals other than swine. Do not 
allow fowl access to feed containing this

[[Page 452]]

preparation or to feces from treated animals.
    (2) Dichlorvos is a cholinesterase inhibitor. Do not use this 
product in animals simultaneously or within a few days before or after 
treatment with or exposure to cholinesterase-inhibiting drugs, 
pesticides, or chemicals. If human or animal poisoning should occur, 
immediately consult a physician or a veterinarian. Atropine is 
antidotal.
    (3) Labeling for Type A articles and Type B feeds must include a 
statement that containers or materials used in packaging such Type A 
articles and Type B feeds are not to be reused and all such packaging 
materials must be destroyed after the product has been used.
    (e) Conditions of use. It is used in swine feed as follows:

----------------------------------------------------------------------------------------------------------------
                                      Combination in
      Dichlorvos  grams/ton             grams/ton         Indications for use       Limitations        Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 348..........................                       Swine up to 70 pounds   Feed as sole ration       054628
                                                         body weight: For the    for 2 consecutive
                                                         removal and control     days. For swine
                                                         of mature, immature,    from 70 pounds to
                                                         and/or fourth-stage     market weight,
                                                         larvae of the           feed as sole
                                                         whipworm (Trichuris     ration at the rate
                                                         suis), nodular worm     of 8.4 pounds of
                                                         (Oesophagostomum        feed per head
                                                         sp.), large roundworm   until the
                                                         (Ascaris suum) and      medicated feed has
                                                         the thick stomach       been consumed. For
                                                         worm (Ascarops          boars, open or
                                                         strongylina) of the     bred gilts, and
                                                         gastrointestinal        sows, feed as sole
                                                         tract..                 ration at the rate
                                                                                 of 4.2 pounds per
                                                                                 head per day for 2
                                                                                 consecutive days..
(ii) 479.........................                       Boars, open or bred     Feed as sole ration       054628
                                                         gilts, and sows: For    at the rate of 6
                                                         the removal and         pounds per head
                                                         control of mature,      for one feeding..
                                                         immature, and/or
                                                         fourth-stage larvae
                                                         of the whipworm
                                                         (Trichuris suis),
                                                         nodular worm
                                                         (Oesophagostomum
                                                         sp.), large roundworm
                                                         (Ascaris suum) and
                                                         the thick stomach
                                                         worm (Ascarops
                                                         strongylina) of the
                                                         gastrointestinal
                                                         tract..
(iii) 334 to 500.................                       Pregnant swine: An aid  Mix into a                054628
                                                         in improving litter     gestation feed to
                                                         production efficiency   provide 1,000
                                                         by increasing pigs      milligrams per
                                                         born alive, birth       head daily during
                                                         weights, survival to    last 30 days of
                                                         market, and rate of     gestation..
                                                         weight gain.
                                                         Treatment also
                                                         removes and controls
                                                         mature, immature and/
                                                         or fourth stage
                                                         larvae of whipworm
                                                         (Trichuris suis),
                                                         nodular worm
                                                         (Oesophagostomum
                                                         spp.) large roundworm
                                                         (Ascaris suum), and
                                                         the thick stomach
                                                         worm (Ascarops
                                                         strongylina)
                                                         occurring in the
                                                         gastrointestinal
                                                         tract of the sow or
                                                         gilt..
----------------------------------------------------------------------------------------------------------------


[84 FR 12497, Apr. 2, 2019]



Sec. 558.205  Diclazuril.

    (a) Specifications. Type A medicated article containing 0.2 percent 
diclazuril.
    (b) Sponsor. See No. 058198 in Sec. 510.600(c) of this chapter.
    (c) Related tolerances. See Sec. 556.185 of this chapter.
    (d) Conditions of use--(1) Chickens. For chickens it is used as 
follows:

[[Page 453]]



----------------------------------------------------------------------------------------------------------------
                                      Combination in
      Diclazuril  grams/ton             grams/ton         Indications for use       Limitations        Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 0.91.........................                       Broiler chickens: For   Feed continuously.        058198
                                                         the prevention of       Not for use in
                                                         coccidiosis caused by   hens producing
                                                         Eimeria tenella, E.     eggs for human
                                                         necatrix, E.            food. Because
                                                         acervulina, E.          diclazuril is
                                                         brunetti, E. mitis      effective against
                                                         (mivati), and E.        E. maxima later in
                                                         maxima.                 its life cycle,
                                                                                 subclinical
                                                                                 intestinal lesions
                                                                                 may be present for
                                                                                 a short time after
                                                                                 infection.
                                                                                 Diclazuril was
                                                                                 shown in studies
                                                                                 to reduce lesion
                                                                                 scores and improve
                                                                                 performance and
                                                                                 health of birds
                                                                                 challenged with E.
                                                                                 maxima.
(ii) 0.91........................  Bacitracin           Broiler chickens: For   Feed continuously.        058198
                                    methylenedisalicyl   the prevention of       Not for use in
                                    ate, 4 to 50.        coccidiosis caused by   hens producing
                                                         Eimeria tenella, E.     eggs for human
                                                         necatrix, E.            food. Because
                                                         acervulina, E.          diclazuril is
                                                         brunetti, E. mitis      effective against
                                                         (mivati), and E.        E. maxima later in
                                                         maxima, and for         its life cycle,
                                                         increased rate of       subclinical
                                                         weight gain and         intestinal lesions
                                                         improved feed           may be present for
                                                         efficiency.             a short time after
                                                                                 infection.
                                                                                 Diclazuril was
                                                                                 shown in studies
                                                                                 to reduce lesion
                                                                                 scores and improve
                                                                                 performance and
                                                                                 health of birds
                                                                                 challenged with E.
                                                                                 maxima. Bacitracin
                                                                                 methylenedisalicyl
                                                                                 ate as provided by
                                                                                 No. 054771 in Sec.
                                                                                   510.600(c) of
                                                                                 this chapter.
(iii) 0.91.......................  Bambermycins, 1 to   Broiler chickens: For   Feed continuously.        058198
                                    2.                   the prevention of       Not for use in
                                                         coccidiosis caused by   hens producing
                                                         Eimeria tenella, E.     eggs for human
                                                         necatrix, E.            food. Because
                                                         acervulina, E.          diclazuril is
                                                         brunetti, E. mitis      effective against
                                                         (mivati), and E.        E. maxima later in
                                                         maxima, and for         its life cycle,
                                                         increased rate of       subclinical
                                                         weight gain and         intestinal lesions
                                                         improved feed           may be present for
                                                         efficiency.             a short time after
                                                                                 infection.
                                                                                 Diclazuril was
                                                                                 shown in studies
                                                                                 to reduce lesion
                                                                                 scores and improve
                                                                                 performance and
                                                                                 health of birds
                                                                                 challenged with E.
                                                                                 maxima.
                                                                                 Bambermycins as
                                                                                 provided by No.
                                                                                 016592 in Sec.
                                                                                 510.600(c) of this
                                                                                 chapter.
----------------------------------------------------------------------------------------------------------------

    (2) Turkeys. For turkeys it is used as follows:

----------------------------------------------------------------------------------------------------------------
                                      Combination in
      Diclazuril  grams/ton             grams/ton         Indications for use       Limitations        Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 0.91.........................                       Growing turkeys: For    Feed continuously         058198
                                                         the prevention of       as the sole
                                                         coccidiosis caused by   ration. Do not
                                                         Eimeria adenoeides,     feed to breeding
                                                         E. gallopavonis and     turkeys. Not for
                                                         E. meleagrimitis..      use in hens
                                                                                 producing eggs for
                                                                                 human consumption..
(ii) 0.91........................  Bacitracin           Growing turkeys: For    Feed continuously         058198
                                    methylenedisalicyl   the prevention of       as the sole
                                    ate, 4 to 50.        coccidiosis caused by   ration. Do not
                                                         Eimeria adenoeides,     feed to breeding
                                                         E. gallopavonis and     turkeys. Not for
                                                         E. meleagrimitis, and   use in hens
                                                         for increased rate of   producing eggs for
                                                         weight gain and         human consumption.
                                                         improved feed           Bacitracin
                                                         efficiency.             methylenedisalicyl
                                                                                 ate as provided by
                                                                                 No. 054771 in Sec.
                                                                                   510.600(c) of
                                                                                 this chapter.

[[Page 454]]

 
(iii) 0.91.......................  Bambermycins, 1 to   Growing turkeys: For    Feed continuously         058198
                                    2.                   the prevention of       as the sole
                                                         coccidiosis caused by   ration. Do not
                                                         Eimeria adenoeides,     feed to breeding
                                                         E. gallopavonis and     turkeys. Not for
                                                         E. meleagrimitis, and   use in hens
                                                         for improved feed       producing eggs for
                                                         efficiency.             human consumption.
                                                                                 Bambermycins as
                                                                                 provided by No.
                                                                                 016592 in Sec.
                                                                                 510.600(c) of this
                                                                                 chapter.
(iv) 0.91........................  Bambermycins, 2....  Growing turkeys: For    Feed continuously         058198
                                                         the prevention of       as the sole
                                                         coccidiosis caused by   ration. Do not
                                                         Eimeria adenoeides,     feed to breeding
                                                         E. gallopavonis and     turkeys. Not for
                                                         E. meleagrimitis, and   use in hens
                                                         for increased rate of   producing eggs for
                                                         weight gain and         human consumption.
                                                         improved feed           Bambermycins as
                                                         efficiency.             provided by No.
                                                                                 016592 in Sec.
                                                                                 510.600(c) of this
                                                                                 chapter.
----------------------------------------------------------------------------------------------------------------

    (3) Diclazuril may also be used in combination with virginiamycin as 
in Sec. 558.635.

[64 FR 35923, July 2, 1999, as amended at 65 FR 50134, Aug. 17, 2000; 66 
FR 47962, 47963, Sept. 17, 2001; 66 FR 62917, Dec. 4, 2001; 67 FR 34830, 
May 16, 2002; 67 FR 47257, July 18, 2002; 67 FR 48549, July 25, 2002; 69 
FR 9947, Mar. 3, 2004; 72 FR 60552, Oct. 25, 2007; 79 FR 10982, Feb. 27, 
2014; 79 FR 13545, Mar. 11, 2014; 81 FR 17609, Mar. 30, 2016; 81 FR 
95004, Dec. 27, 2016. Redesignated and amended at 84 FR 12497, 12498, 
Apr. 2, 2019]



Sec. 558.235  Efrotomycin.

    (a) Specifications. Type A medicated articles containing 14.5 grams 
efrotomycin per pound.
    (b) Sponsor. See No. 000010 in Sec. 510.600(c) of this chapter.
    (c) Related tolerances. See Sec. 556.224 of this chapter.
    (d) Conditions of use in swine--

----------------------------------------------------------------------------------------------------------------
     Efrotomycin  in grams/ton             Indications for use                  Limitations             Sponsor
----------------------------------------------------------------------------------------------------------------
(1) 3.6............................  Swine: For improved feed         Feed continuously as sole           000010
                                      efficiency.                      ration. Not to be used in
                                                                       swine weighing more than 250
                                                                       pounds.
(2) 3.6 to 14.5....................  Swine: For increased rate of     Feed continuously as sole           000010
                                      weight gain.                     ration. Not to be used in
                                                                       swine weighing more than 250
                                                                       pounds.
----------------------------------------------------------------------------------------------------------------


[57 FR 38442, Aug. 25, 1992, as amended at 62 FR 63271, Nov. 28, 1997; 
84 FR 33001, July 11, 2019; 84 FR 39185, Aug. 9, 2019; 85 FR 45309, July 
28, 2020]



Sec. 558.248  Erythromycin.

    (a) Specifications. Type A medicated articles containing 92.5 grams 
per pound erythromycin (as the thiocyanate salt).
    (b) Sponsor. See No. 061133 in Sec. 510.600(c) of this chapter.
    (c) Related tolerances. See Sec. 556.230 of this chapter.
    (d) Special considerations. (1) Federal law restricts medicated feed 
containing this veterinary feed directive (VFD) drug to use by or on the 
order of a licensed veterinarian. See Sec. 558.6 for additional 
requirements.
    (2) The expiration date of VFDs for erythromycin medicated feeds 
must not exceed 6 months from the date of issuance. VFDs for 
erythromycin shall not be refilled.
    (e) Conditions of use--(1) Chickens--

[[Page 455]]



----------------------------------------------------------------------------------------------------------------
                                     Combination in
    Erythromycin in grams/ton          grams/ton        Indications for use       Limitations         Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 92.5........................  ...................  Chickens: As an aid    Feed for 2 days             061623
                                                        in the prevention of   before stress and
                                                        chronic respiratory    3 to 6 days after
                                                        disease during         stress. Withdraw
                                                        periods of stress.     24 hours before
                                                                               slaughter.
(ii) 92.5.......................  ...................  Chickens: As an aid    Feed for 7 to 14            061623
                                                        in the prevention of   days. Withdraw 24
                                                        infectious coryza.     hours before
                                                                               slaughter.
(iii) 185.......................  ...................  Chickens: As an aid    Feed for 5 to 8             061623
                                                        in the prevention      days. Withdraw 48
                                                        and reduction of       hours before
                                                        lesions and in         slaughter. Do not
                                                        lowering severity of   use in birds
                                                        chronic respiratory    producing eggs
                                                        disease (CRD).         for food.
----------------------------------------------------------------------------------------------------------------

    (2) Turkeys--

----------------------------------------------------------------------------------------------------------------
   Erythromycin thiocyanate in       Combination in
            grams/ton                  grams/ton        Indications for use       Limitations         Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 92.5........................  ...................  Turkeys: As an aid in  Feed for 2 days             061623
                                                        the prevention of      before stress and
                                                        chronic respiratory    3 to 6 days after
                                                        disease during         stress.
                                                        periods of stress.
(ii) 185........................  ...................  Turkeys: As an aid in  Feed for 5 to 8             061623
                                                        the prevention and     days. Do not use
                                                        reduction of lesions   in birds
                                                        and in lowering        producing eggs
                                                        severity of chronic    for food.
                                                        respiratory disease
                                                        (CRD).
----------------------------------------------------------------------------------------------------------------


[41 FR 10999, Mar. 15, 1976, as amended at 45 FR 56799, Aug. 26, 1980; 
49 FR 31281, Aug. 6, 1984; 51 FR 7397, Mar. 3, 1986; 52 FR 2684, Jan. 
26, 1987; 54 FR 12189, Mar. 24, 1989; 66 FR 14074, Mar. 9, 2001; 68 FR 
4915, Jan. 31, 2003; 79 FR 10982, Feb. 27, 2014; 81 FR 36790, June 8, 
2016; 81 FR 95004, Dec. 27, 2016; 84 FR 8975, Mar. 13, 2019]



Sec. 558.254  Famphur.

    (a) Specifications. Type A medicated articles containing 13.2 or 
33.3 percent famphur.
    (b) Sponsor. See No. 000061 in Sec. 510.600(c) of this chapter.
    (c) Related tolerances. See Sec. 556.273 of this chapter.
    (d) Special considerations. Famphur is a cholinesterase inhibitor. 
Do not use this product in animals simultaneously or within a few days 
before or after treatment with or exposure to cholinesterase-inhibiting 
drugs, pesticides, or chemicals.
    (e) Conditions of use. It is used in cattle feed as follows:

                                     Table 2--Size Proxies for SRCs in 2016
----------------------------------------------------------------------------------------------------------------
        Famphur in grams/ton               Indications for use               Limitations              Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 1.1 milligrams per pound (mg/lb)  Beef cattle and nonlactating  Feed for 30 days. Withdraw            000061
 body weight per day.                  dairy cows: For control of    from dry dairy cows and
                                       grubs and as an aid in        heifers 21 days prior to
                                       control of sucking lice.      freshening. Withdraw 4 days
                                                                     prior to slaughter.
(ii) 2.3 mg/lb body weight per day..  Beef cattle and nonlactating  Feed for 10 days. Withdraw            000061
                                       dairy cows: For control of    from dry dairy cows and
                                       grubs.                        heifers 21 days prior to
                                                                     freshening. Withdraw 4 days
                                                                     prior to slaughter.
----------------------------------------------------------------------------------------------------------------


[84 FR 39185, Aug. 9, 2019]



Sec. 558.258  Fenbendazole.

    (a) Specifications. Type A medicated articles: 4 percent (18.1 grams 
per pound (g/lb)), 8 percent (36.2 g/lb), and 20 percent (90.7 g/lb) 
fenbendazole.
    (b) Sponsor. See No. 000061 in Sec. 510.600(c) of this chapter.
    (c) Related tolerances. See Sec. 556.275 of this chapter.
    (d) Special considerations. See Sec. 500.25 of this chapter.
    (e) Conditions of use--(1) Turkeys.

[[Page 456]]



----------------------------------------------------------------------------------------------------------------
 Amount fenbendazole in grams per  Combination in grams
               ton                        per ton          Indications for use        Limitations       Sponsor
----------------------------------------------------------------------------------------------------------------
14.5 (16 parts per million)......  ....................  Growing turkeys: For     Feed continuously       000061
                                                          the removal and          as the sole ration
                                                          control of               for 6 days. For
                                                          gastrointestinal         growing turkeys
                                                          worms: roundworms,       only.
                                                          adult and larvae
                                                          (Ascaridia
                                                          dissimilis); cecal
                                                          worms, adult and
                                                          larvae (Heterakis
                                                          gallinarum), an
                                                          important vector of
                                                          Histomonas meleagridis
                                                          (Blackhead).
----------------------------------------------------------------------------------------------------------------

    (2) Swine.

----------------------------------------------------------------------------------------------------------------
                                      Combination in
  Fenbendazole in  grams per ton      grams per ton       Indications for use       Limitations        Sponsors
----------------------------------------------------------------------------------------------------------------
(i) 10 to 300 (to provide 9                             For the removal and     Feed as the sole          000061
 milligrams per kilogram (mg/kg)                         control of adult        ration.
 of body weight) given over a 3-                         stage lungworms
 to 12-day period.                                       (Metastrongylus apri
                                                         and M.
                                                         pudendotectus); adult
                                                         and larvae (L3, 4
                                                         stages--liver, lung,
                                                         intestinal forms)
                                                         large roundworms
                                                         (Ascaris suum); adult
                                                         stage nodular worms
                                                         (Oesophagostomum
                                                         dentatum, O.
                                                         quadrispinulatum);
                                                         adult stage small
                                                         stomach worms
                                                         (Hyostrongylus
                                                         rubidus); adult and
                                                         larvae (L2, 3, 4
                                                         stages--intestinal
                                                         mucosal forms)
                                                         whipworms (Trichuris
                                                         suis); adult and
                                                         larvae kidney worms
                                                         (Stephanurus
                                                         dentatus).
(ii) 10 to 300 (to provide 9 mg/   Bacitracin           Growing/finishing       Feed as the sole          054771
 kg of body weight).                methylenedisalicyl   swine: For the          ration. Under
                                    ate, 10 to 30.       removal and control     conditions of
                                                         of adult stage          continued exposure
                                                         lungworms               to parasites,
                                                         (Metastrongylus apri    retreatment may be
                                                         and M.                  needed after 4 to
                                                         pudendotectus); adult   6 weeks.
                                                         and larvae (L3, 4       Bacitracin
                                                         stages--liver, lung,    methylenedisalicyl
                                                         intestinal forms)       ate as provided by
                                                         large roundworms        No. 054771 in Sec.
                                                         (Ascaris suum); adult     510.600(c) of
                                                         stage nodular worms     this chapter.
                                                         (Oesophagostomum
                                                         dentatum, O.
                                                         quadrispinulatum);
                                                         adult stage small
                                                         stomach worms
                                                         (Hyostrongylus
                                                         rubidus); adult and
                                                         larvae (L2, 3, 4
                                                         stages--intestinal
                                                         mucosal forms)
                                                         whipworms (Trichuris
                                                         suis); adult and
                                                         larvae kidney worms
                                                         (Stephanurus
                                                         dentatus); and for
                                                         increased rate of
                                                         weight gain and
                                                         improved feed
                                                         efficiency.

[[Page 457]]

 
(iii) 10 to 300 (to provide 9 mg/  Bacitracin           1. Growing/finishing    1. Growing/               054771
 kg of body weight).                methylenedisalicyl   swine: For the          finishing swine:
                                    ate, 250.            removal and control     Feed as sole
                                                         of adult stage          ration. Not for
                                                         lungworms               use in growing and
                                                         (Metastrongylus apri    finishing swine
                                                         and M.                  that weigh more
                                                         pudendotectus); adult   than 250 lbs.
                                                         and larvae (L3, 4       Diagnosis of swine
                                                         stages--liver, lung,    dysentery should
                                                         intestinal forms)       be confirmed by a
                                                         large roundworms        veterinarian when
                                                         (Ascaris suum); adult   results are not
                                                         stage nodular worms     satisfactory.
                                                         (Oesophagostomum        Under conditions
                                                         dentatum, O.            of continued
                                                         quadrispinulatum);      exposure to
                                                         adult stage small       parasites,
                                                         stomach worms           retreatment may be
                                                         (Hyostrongylus          needed after 4 to
                                                         rubidus); adult and     6 weeks.
                                                         larvae (L2, 3, 4        Bacitracin
                                                         stages--intestinal      methylenedisalicyl
                                                         mucosal forms)          ate as provided by
                                                         whipworms (Trichuris    No. 054771 in Sec.
                                                         suis); adult and          510.600(c) of
                                                         larvae kidney worms     this chapter.
                                                         (Stephanurus
                                                         dentatus); and for
                                                         control of swine
                                                         dysentery associated
                                                         with Treponema
                                                         hyodysenteriae on
                                                         premises with a
                                                         history of swine
                                                         dysentery, but where
                                                         signs of disease have
                                                         not yet occurred; or
                                                         following an approved
                                                         treatment of the
                                                         disease condition.
                                                        2. Pregnant sows: For   2. Pregnant sows:
                                                         the removal and         Feed as sole
                                                         control of adult        ration. Diagnosis
                                                         stage lungworms         of clostridial
                                                         (Metastrongylus apri    enteritis should
                                                         and M.                  be confirmed by a
                                                         pudendotectus); adult   veterinarian when
                                                         and larvae (L3, 4       results are not
                                                         stages--liver, lung,    satisfactory.
                                                         intestinal forms)       Under conditions
                                                         large roundworms        of continued
                                                         (Ascaris suum); adult   exposure to
                                                         stage nodular worms     parasites,
                                                         (Oesophagostomum        retreatment may be
                                                         dentatum, O.            needed after 4 to
                                                         quadrispinulatum);      6 weeks.
                                                         adult stage small       Bacitracin
                                                         stomach worms           methylenedisalicyl
                                                         (Hyostrongylus          ate as provided by
                                                         rubidus); adult and     No. 054771 in Sec.
                                                         larvae (L2, 3, 4          510.600(c) of
                                                         stages--intestinal      this chapter.
                                                         mucosal forms)
                                                         whipworms (Trichuris
                                                         suis); adult and
                                                         larvae kidney worms
                                                         (Stephanurus
                                                         dentatus); for
                                                         control of
                                                         clostridial enteritis
                                                         in suckling pigs
                                                         caused by Clostridium
                                                         perfringens.
----------------------------------------------------------------------------------------------------------------

    (3) Cattle.

[[Page 458]]



------------------------------------------------------------------------
     Amount      Indications for
  fenbendazole         use            Limitations           Sponsor
------------------------------------------------------------------------
(i) 5 mg/kg      Dairy and beef   Feed as the sole    000061
 body weight      cattle: For      ration or as a
 (2.27 mg/lb)     the removal      top dress for one
                  and control      day. Retreatment
                  of: Lungworms    may be needed
                  (Dictyocaulus    after 4 to 6
                  viviparus);      weeks. Cattle
                  Stomach worms:   must not be
                  barberpole       slaughtered
                  worms            within 13 days
                  (Haemonchus      following last
                  contortus),      treatment. For
                  brown stomach    dairy cattle the
                  worms            milk discard time
                  (Ostertagia      is zero hours. A
                  ostertagi),      withdrawal period
                  small stomach    has not been
                  worms            established for
                  (Trichostrongy   this product in
                  lus axei);       pre-ruminating
                  Intestinal       calves. Do not
                  worms:           use in calves to
                  hookworms        be processed for
                  (Bunostomum      veal..
                  phlebotomum),
                  thread-necked
                  intestinal
                  worms
                  (Nematodirus
                  helvetianus),
                  small
                  intestinal
                  worms
                  (Cooperia
                  oncophora and
                  C. punctata);
                  Bankrupt worms
                  (Trichostrongy
                  lus
                  colubriformis)
                  ; and Nodular
                  worms
                  (Oesophagostom
                  um radiatum).
(ii) [Reserved]
------------------------------------------------------------------------

    (iii) Free-choice feeds--(A) Amount. 5 mg/kg body weight (2.27 mg/
lb), including the following formulations:

----------------------------------------------------------------------------------------------------------------
              Ingredient\1\                             Percent                     International Feed No.
----------------------------------------------------------------------------------------------------------------
(1) Free-choice, dry Type C feed:         ..................................  ..................................
 Salt (sodium chloride)                                                59.00                            6-04-152
 Monosodium phosphate                                                  31.16                            6-04-288
 Dried cane molasses                                                    3.12                            4-04-695
 Zinc sulfate                                                           0.76                            6-05-556
 Copper sulfate                                                         0.45                            6-01-720
 Fenbendazole 20% Type A article                                        5.51                                 n/a
(2) Free-choice, dry Type C feed:         ..................................  ..................................
 Salt (sodium chloride)                                                35.93                            6-04-152
 Dicalcium phosphate (18.5% P)                                         32.44                            6-00-080
 Calcium carbonate (38% Ca)                                            15.93                            6-01-069
 Magnesium oxide (56% Mg)                                              10.14                            6-02-756
 Zinc sulfate                                                           1.47                            6-05-556
 Mineral oil                                                            1.00                            8-03-123
 Dried cane molasses (46% sugars)                                       0.98                            4-04-695
 Potassium iodide                                                       0.01                            6-03-759
 Fenbendazole 20% Type A article                                        2.10                                 n/a
(3) Free-choice, liquid Type C feed:
 Cane molasses\2\                                                     80.902                            4-13-251
 Water                                                                  9.36                                 n/a
 Urea solution, 55%                                                     7.05                            5-05-707
 Phosphoric acid 75% (feed grade)                                       2.00                            6-03-707
 Xantham gum                                                            0.20                            8-15-818
 Trace minerals                                                         0.20                                 n/a
 Vitamin premix                                                         0.01                                 n/a
 Fenbendazole 20% Type A article                                       0.278                                 n/a
----------------------------------------------------------------------------------------------------------------
\1\The content of any added vitamin and trace mineral may be varied; however, they should be comparable to those
  used by the manufacturer for other free-choice cattle feeds. Formulation modifications require FDA approval
  prior to marketing. Selenium is not approved for the free-choice formulations described in paragraph
  (e)(3)(iii) of this section. Free-choice cattle feeds containing selenium must comply with published
  regulations (see 21 CFR 573.920).
\2\The percentage of cane molasses and water in the formulation may be adjusted as needed in order to bring the
  brix value of the molasses to the industry standard of 79.5 brix.


[[Page 459]]

    (B) Indications for use. As in paragraph (e)(3)(i) of this section.
    (C) Limitations. Feed a total of 5 mg of fenbendazole per kg (2.27 
mg/lb) of body weight to cattle over a 3- to 6-day period. Retreatment 
may be needed after 4 to 6 weeks. Cattle must not be slaughtered within 
13 days following last treatment. For dairy cattle the milk discard time 
is zero hours. A withdrawal period has not been established for this 
product in pre-ruminating calves. Do not use in calves to be processed 
for veal.
    (4) Horses.

----------------------------------------------------------------------------------------------------------------
 Amount fenbendazole in grams per ton         Indications for use                Limitations            Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 4,540.............................  5 mg/kg body weight (2.27 mg/   Feed at the rate of 0. 1lb of     000061
                                         lb) for the control of large    feed per 100 lb of body
                                         strongyles (Strongylus          weight to provide 2.27 mg
                                         edentatus, S. equinus, S.       fenbendazole/lb of body
                                         vulgaris, Triodontophorus       weight in a 1-day treatment
                                         spp.), small strongyles         or 0.2 lb of feed per 100 lb
                                         (Cyathostomum spp.,             of body weight to provide
                                         Cylicocyclus spp.,              4.54 mg fenbendazole/lb of
                                         Cylicostephanus spp.), and      body weight in a 1-day
                                         pinworms (Oxyuris equi); 10     treatment. All horses must
                                         mg/kg body weight (4.54 mg/     be eating normally to ensure
                                         lb) for the control of          that each animal consumes an
                                         ascarids (Parascaris            adequate amount of the
                                         equorum)..                      medicated feed. Regular
                                                                         deworming at intervals of 6
                                                                         to 8 weeks may be required
                                                                         due to the possibility of
                                                                         reinfection. Do not use in
                                                                         horses intended for human
                                                                         consumption..
(ii) [Reserved].......................  ..............................  .............................  .........
----------------------------------------------------------------------------------------------------------------

    (5) Zoo and wildlife animals.

----------------------------------------------------------------------------------------------------------------
          Species/Class             Amount fenbendazole    Indications for use        Limitations       Sponsor
----------------------------------------------------------------------------------------------------------------
(i) Feral swine (Sus scrofa).....  3 mg/kg/day for 3     For the removal and      Use as complete         000061
                                    days..                control of kidney worm   feed. Prior
                                                          (Stephanurus             withdrawal of feed
                                                          dentatus), roundworm     or water is not
                                                          (Ascaris suum),          necessary.
                                                          nodular worm             Retreatment may be
                                                          (Oesophagostomum         required in 6
                                                          dentatum).               weeks. Do not use
                                                                                   14 days before or
                                                                                   during the hunting
                                                                                   season.
(ii) Ruminants (subfamily          2.5 mg/kg/day for 3   For the removal and      Use as complete         000061
 Antilopinae, Hippotraginae,        days..                control of small         feed. Prior
 Caprinae).                                               stomach worm             withdrawal of feed
                                                          (Trichostrongylus        or water is not
                                                          spp.), thread necked     necessary.
                                                          intestinal worm          Retreatment may be
                                                          (Nematodirus spp.),      required in 6
                                                          barberpole worm          weeks. Do not use
                                                          (Haemonchus spp.),       14 days before or
                                                          whipworm (Trichuris      during the hunting
                                                          spp.).                   season.
(iii) Rocky mountain bighorn       10 mg/kg/day for 3    For the removal and      Use as complete         000061
 sheep (Ovis c. canadensis).        days..                control of               feed. Prior
                                                          Protostrongylus spp.     withdrawal of feed
                                                                                   or water is not
                                                                                   necessary.
                                                                                   Retreatment may be
                                                                                   required in 6
                                                                                   weeks. Do not use
                                                                                   14 days before or
                                                                                   during the hunting
                                                                                   season.
----------------------------------------------------------------------------------------------------------------

    (6) Fenbendazole may also be used in combination with:
    (i) [Reserved]
    (ii) Lincomycin as in Sec. 558.325.

[66 FR 58935, Nov. 26, 2001, as amended at 68 FR 34534, June 10, 2003; 
72 FR 66046, Nov. 27, 2007; 73 FR 58873, Oct. 8, 2008; 74 FR 61517, Nov. 
25, 2009; 79 FR 13545, Mar. 11, 2014; 81 FR 17609, Mar. 30, 2016; 81 FR 
95005, Dec. 27, 2016; 84 FR 12499, Apr. 2, 2019; 86 FR 14822, Mar. 19, 
2021]



Sec. 558.261  Florfenicol.

    (a) Specifications. Type A medicated articles containing florfenicol 
in the following concentrations:
    (1) 40 grams per kilogram for use as in paragraph (e)(1) of this 
section.
    (2) 500 grams per kilogram for use as in paragraph (e)(2) of this 
section.
    (b) Sponsor. See No. 000061 in Sec. 510.600(c) of this chapter.

[[Page 460]]

    (c) Related tolerances. See Sec. 556.283 of this chapter.
    (d) Special considerations. (1) Federal law restricts medicated feed 
containing this veterinary feed directive (VFD) drug to use by or on the 
order of a licensed veterinarian. See Sec. 558.6 for additional 
requirements.
    (2) The expiration date of VFDs for florfenicol medicated feeds:
    (i) For swine must not exceed 90 days from the date of issuance.
    (ii) For fish must not exceed 6 months from the date of issuance.
    (3) VFDs for florfenicol shall not be refilled.
    (4) Type A medicated articles and medicated feeds intended for use 
in fish shall bear the following: ``Not for use in animals intended for 
breeding purposes. The effects of florfenicol on reproductive 
performance have not been determined. Toxicity studies in dogs, rats, 
and mice have associated the use of florfenicol with testicular 
degeneration and atrophy.''
    (e) Conditions of use--(1) Swine--

------------------------------------------------------------------------
 Florfenicol in grams/ton of
            feed               Indications for use       Limitations
------------------------------------------------------------------------
182.........................  For the control of    Feed continuously as
                               swine respiratory     a sole ration for 5
                               disease (SRD)         consecutive days.
                               associated with       The safety of
                               Actinobacillus        florfenicol on
                               pleuropneumoniae,     swine reproductive
                               Pasteurella           performance,
                               multocida,            pregnancy, and
                               Streptococcus suis,   lactation have not
                               and Bordetella        been determined.
                               bronchiseptica in     Feeds containing
                               groups of swine in    florfenicol must be
                               buildings             withdrawn 13 days
                               experiencing an       prior to slaughter.
                               outbreak of SRD..
------------------------------------------------------------------------

    (2) Fish--

------------------------------------------------------------------------
 Florfenicol in grams/ton of
            feed               Indications for use       Limitations
------------------------------------------------------------------------
(i) 182 to 2,724............  Catfish: For the      Feed as a sole
                               control of            ration for 10
                               mortality due to      consecutive days to
                               enteric septicemia    deliver 10 to 15
                               of catfish            milligrams (mg)
                               associated with       florfenicol per
                               Edwardsiella          kilogram (kg) of
                               ictaluri.             fish. Feed
                                                     containing
                                                     florfenicol shall
                                                     not be fed for more
                                                     than 10 days.
                                                     Following
                                                     administration,
                                                     fish should be
                                                     reevaluated by a
                                                     licensed
                                                     veterinarian before
                                                     initiating a
                                                     further course of
                                                     therapy. A dose-
                                                     related decrease in
                                                     hematopoietic/
                                                     lymphopoietic
                                                     tissue may occur.
                                                     The time required
                                                     for hematopoietic/
                                                     lymphopoietic
                                                     tissues to
                                                     regenerate was not
                                                     evaluated. The
                                                     effects of
                                                     florfenicol on
                                                     reproductive
                                                     performance have
                                                     not been
                                                     determined. Feeds
                                                     containing
                                                     florfenicol must be
                                                     withdrawn 15 days
                                                     prior to slaughter.
------------------------------------------------------------------------
(ii) 182 to 2,724...........  Freshwater-reared     Feed as a sole
                               salmonids: For the    ration for 10
                               control of            consecutive days to
                               mortality due to      deliver 10 to 15 mg
                               coldwater disease     florfenicol per kg
                               associated with       of fish. Feed
                               Flavobacterium        containing
                               psychrophilum and     florfenicol shall
                               furunculosis          not be fed for more
                               associated with       than 10 days.
                               Aeromonas             Following
                               salmonicida.          administration,
                                                     fish should be
                                                     reevaluated by a
                                                     licensed
                                                     veterinarian before
                                                     initiating a
                                                     further course of
                                                     therapy. The
                                                     effects of
                                                     florfenicol on
                                                     reproductive
                                                     performance have
                                                     not been
                                                     determined. Feeds
                                                     containing
                                                     florfenicol must be
                                                     withdrawn 15 days
                                                     prior to slaughter.
------------------------------------------------------------------------

[[Page 461]]

 
(iii) 182 to 2,724..........  Freshwater-reared     Feed as a sole
                               finfish: For the      ration for 10
                               control of            consecutive days to
                               mortality due to      deliver 10 to 15 mg
                               columnaris disease    florfenicol per kg
                               associated with       of fish for
                               Flavobacterium        freshwater-reared
                               columnare.            warmwater finfish
                                                     and other
                                                     freshwater-reared
                                                     finfish. Feed
                                                     containing
                                                     florfenicol shall
                                                     not be fed for more
                                                     than 10 days.
                                                     Following
                                                     administration,
                                                     fish should be
                                                     reevaluated by a
                                                     licensed
                                                     veterinarian before
                                                     initiating a
                                                     further course of
                                                     therapy. For
                                                     catfish, a dose-
                                                     related decrease in
                                                     hematopoietic/
                                                     lymphopoietic
                                                     tissue may occur.
                                                     The time required
                                                     for hematopoietic/
                                                     lymphopoietic
                                                     tissues to
                                                     regenerate was not
                                                     evaluated. The
                                                     effects of
                                                     florfenicol on
                                                     reproductive
                                                     performance have
                                                     not been
                                                     determined. Feeds
                                                     containing
                                                     florfenicol must be
                                                     withdrawn 15 days
                                                     prior to slaughter.
------------------------------------------------------------------------
(iv) 273 to 2,724...........  Freshwater-reared     Feed as a sole
                               warmwater finfish:    ration for 10
                               For the control of    consecutive days to
                               mortality due to      deliver 15 mg
                               streptococcal         florfenicol per kg
                               septicemia            of fish. Feed
                               associated with       containing
                               Streptococcus iniae.  florfenicol shall
                                                     not be fed for more
                                                     than 10 days.
                                                     Following
                                                     administration,
                                                     fish should be
                                                     reevaluated by a
                                                     licensed
                                                     veterinarian before
                                                     initiating a
                                                     further course of
                                                     therapy. For
                                                     catfish, a dose-
                                                     related decrease in
                                                     hematopoietic/
                                                     lymphopoietic
                                                     tissue may occur.
                                                     The time required
                                                     for hematopoietic/
                                                     lymphopoietic
                                                     tissues to
                                                     regenerate was not
                                                     evaluated. The
                                                     effects of
                                                     florfenicol on
                                                     reproductive
                                                     performance have
                                                     not been
                                                     determined. Feeds
                                                     containing
                                                     florfenicol must be
                                                     withdrawn 15 days
                                                     prior to slaughter.
------------------------------------------------------------------------


[70 FR 70047, Nov. 21, 2005, as amended at 71 FR 70304, Dec. 4, 2006; 72 
FR 19798, Apr. 20, 2007; 72 FR 65885, Nov. 26, 2007; 77 FR 32012, May 
31, 2012; 79 FR 18159, Apr. 1, 2014; 80 FR 76387, Dec. 9, 2015; 81 FR 
17609, Mar. 30, 2016; 81 FR 67152, Sept. 30, 2016; 86 FR 14822, Mar. 19, 
2021]



Sec. 558.265  Halofuginone.

    (a) Specifications. Type A medicated articles containing 6 grams of 
halofuginone hydrobromide per kilogram.
    (b) Sponsor. See No. 016592 in Sec. 510.600(c) of this chapter.
    (c) Related tolerances. See Sec. 556.308 of this chapter.
    (d) Conditions of use. It is used in feed as follows:
    (1) Chickens--

----------------------------------------------------------------------------------------------------------------
                                   Combination in grams/
    Halofuginone in grams/ton               ton            Indications for use        Limitations       Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 2.72.........................  ....................  Broiler chickens: For    Feed continuously       016592
                                                          the prevention of        as sole ration. Do
                                                          coccidiosis caused by    not feed to
                                                          Eimeria tenella, E.      layers. Withdraw 4
                                                          necatrix, E.             days before
                                                          acervulina, E.           slaughter.
                                                          brunetti, E. mivati,
                                                          and E. maxima.
(ii) 2.72........................  Bacitracin            Broiler chickens: For    Feed continuously       016592
                                    methylenedisalicyla   the prevention of        as sole ration. Do
                                    te, 10 to 50.         coccidiosis caused by    not feed to
                                                          Eimeria tenella, E.      layers. Withdraw 5
                                                          necatrix, E.             days before
                                                          acervulina, E.           slaughter.
                                                          brunetti, E. mivati,
                                                          and E. maxima; for
                                                          improved feed
                                                          efficiency.
(iii) 2.72.......................  Bambermycins, 1 to 2  Broiler chickens: For    Feed continuously       016592
                                                          the prevention of        as sole ration. Do
                                                          coccidiosis caused by    not feed to
                                                          Eimeria tenella, E.      layers. Withdraw 5
                                                          necatrix, E,             days before
                                                          acervulina, E.           slaughter.
                                                          brunetti, E. mivati,
                                                          and E. maxima; for
                                                          increased rate of
                                                          weight gain and
                                                          improved feed
                                                          efficiency.

[[Page 462]]

 
(iv) 2.72........................  ....................  Replacement broiler      Feed continuously       016592
                                                          breeder chickens and     as sole ration to
                                                          replacement cage         replacement cage
                                                          laying chickens: For     laying chickens
                                                          the prevention of        until 20 weeks of
                                                          coccidiosis caused by    age. Feed
                                                          Eimeria tenella, E.      continuously as
                                                          necatrix, E.             sole ration to
                                                          acervulina, E. maxima,   replacement
                                                          E. mivati/E. mitis,      broiler breeder
                                                          and E. brunetti.         chickens until 16
                                                                                   weeks of age. Do
                                                                                   not feed to laying
                                                                                   chickens or water
                                                                                   fowl. Withdraw 4
                                                                                   days before
                                                                                   slaughter.
----------------------------------------------------------------------------------------------------------------

    (2) Turkeys--

----------------------------------------------------------------------------------------------------------------
                                   Combination in grams/
    Halofuginone in grams/ton               ton            Indications for use        Limitations       Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 1.36 to 2.72.................  ....................  Growing turkeys: For     Feed continuously       016592
                                                          the prevention of        as sole ration.
                                                          coccidiosis caused by    Withdraw 7 days
                                                          Eimeria adenoeides, E.   before slaughter.
                                                          meleagrimitis, and E.    Do not feed to
                                                          gallopavonis.            layers or water
                                                                                   fowl.
(ii) 1.36 to 2.72................  Bacitracin            Growing turkeys: For     Feed continuously       016592
                                    methylenedisalicyla   the prevention of        as sole ration.
                                    te, 10 to 50.         coccidiosis caused by    Withdraw 7 days
                                                          Eimeria adenoeides, E.   before slaughter.
                                                          meleagrimitis, and E.    Do not feed to
                                                          gallopavonis, and for    laying chickens or
                                                          increased rate of        water fowl.
                                                          weight gain.
(iii) 1.36 to 2.72...............  Bambermycins, 2.....  Growing turkeys: For     Feed continuously       016592
                                                          the prevention of        as sole ration.
                                                          coccidiosis caused by    Withdraw 7 days
                                                          Eimeria adenoeides, E.   before slaughter.
                                                          meleagrimitis, and E.    Do not feed to
                                                          gallopavonis, and for    laying chickens or
                                                          increased rate of        waterfowl.
                                                          weight gain.
----------------------------------------------------------------------------------------------------------------

    (3) Halofuginone may also be used in combination with:
    (i) Lincomycin as in Sec. 558.325.
    (ii) [Reserved]

[50 FR 33719, Aug. 21, 1985, as amended at 50 FR 42518, Oct. 21, 1985; 
51 FR 7397, Mar. 3, 1986; 51 FR 11439, Apr. 3, 1986; 51 FR 14989, Apr. 
22, 1986; 51 FR 23737, July 1, 1986; 53 FR 1018, Jan. 15, 1988; 53 FR 
11065, Apr. 5, 1988; 54 FR 11519, Mar. 21, 1989; 54 FR 28052, July 5, 
1989; 59 FR 51498, Oct. 12, 1994; 61 FR 21076, May 9, 1996; 61 FR 24694, 
May 16, 1996; 64 FR 42597, Aug. 5, 1999; 65 FR 45712, July 25, 2000; 66 
FR 47962, Sept. 17, 2001; 71 FR 27956, May 15, 2006; 79 FR 10982, Feb. 
27, 2014; 84 FR 8975, Mar. 13, 2019]



Sec. 558.274  Hygromycin B.

    (a) Specifications. Type A medicated articles containing 2.4 or 8 
grams hygromycin B per pound (g/lb).
    (b) Sponsor. See No. 058198 in Sec. 510.600(c) of this chapter for 
as follows:
    (c) Related tolerances. See Sec. 556.330 of this chapter.
    (d) Special considerations. (1) Federal law restricts medicated feed 
containing this veterinary feed directive (VFD) drug to use by or on the 
order of a licensed veterinarian. See Sec. 558.6 for additional 
requirements.
    (2) The expiration date of VFDs for hygromycin B medicated feeds 
must not exceed 6 months from the date of issuance. VFDs for hygromycin 
B shall not be refilled.
    (e) Conditions of use. It is used in feed as follows:
    (1) Chickens--

----------------------------------------------------------------------------------------------------------------
                               Combination in grams/
   Hygromycin B grams/ton               ton              Indications for use         Limitations        Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 8 to 12.................  .......................  Chickens: For control   Use in complete feed.      058198
                                                        of infections of        Withdraw 3 days
                                                        large roundworms        before slaughter.
                                                        (Ascaris galli),
                                                        cecal worms
                                                        (Heterakis gallinae),
                                                        and capillary worms
                                                        (Capillaria
                                                        obsignata).
(ii) [Reserved]
----------------------------------------------------------------------------------------------------------------


[[Page 463]]

    (2) Swine--

----------------------------------------------------------------------------------------------------------------
                               Combination in grams/
   Hygromycin B grams/ton               ton              Indications for use         Limitations        Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 12......................  .......................  Swine: For control of   In market hogs, use in     058198
                                                        infections of large     complete feed for 8
                                                        roundworms (A. suis),   weeks during the
                                                        nodular worms (O.       growing period.
                                                        dentatum), and          Withdraw 15 days
                                                        whipworms (Trichuris    before slaughter.
                                                        suis).
(ii) [Reserved]
----------------------------------------------------------------------------------------------------------------


[81 FR 95005, Dec. 27, 2016]



Sec. 558.295  Iodinated casein.

    (a) Specifications. Type A medicated article containing iodinated 
casein.
    (b) Sponsor. See No. 017762 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use--(1) Ducks--

----------------------------------------------------------------------------------------------------------------
        Amount in grams/ton                Indications for use                  Limitations             Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 100 to 200.....................  Growing ducks: For increased     ..............................      017762
                                      rate of weight gain.
(ii) [Reserved]
----------------------------------------------------------------------------------------------------------------

    (2) Dairy cows--

----------------------------------------------------------------------------------------------------------------
       Amount in grams/pound               Indications for use                  Limitations             Sponsor
----------------------------------------------------------------------------------------------------------------
(1) 0.5 to 1.5 per 100 lb of body    Dairy cows: For increased milk   This drug is effective for          017762
 weight.                              production.                      limited periods of time, and
                                                                       the effectiveness is limited
                                                                       to the declining phase of
                                                                       lactation. Administration
                                                                       must be accompanied with
                                                                       increased feed intake.
                                                                       Administration may increase
                                                                       heat sensitivity of the
                                                                       animal.
(2) [Reserved]
----------------------------------------------------------------------------------------------------------------


[85 FR 45309, July 28, 2020, as amended at 86 FR 14823, Mar. 19, 2021]



Sec. 558.300  Ivermectin.

    (a) Specifications. Type A medicated article containing 2.72 grams 
ivermectin per pound (g/lb).
    (b) Sponsor. See No. 000010 in Sec. 510.600(c) of this chapter.
    (c) Related tolerances. See Sec. 556.344 of this chapter.
    (d) Special considerations. See Sec. 500.25 of this chapter.
    (e) Conditions of use in swine. It is used in feed as follows:

[[Page 464]]



----------------------------------------------------------------------------------------------------------------
                                   Combination in grams/
     Ivermectin in  grams/ton               ton            Indications for use        Limitations       Sponsor
----------------------------------------------------------------------------------------------------------------
(1) 1.8..........................                        Weaned, growing-         Feed as the only        000010
                                                          finishing swine: For     feed for 7
                                                          treatment and control    consecutive days
                                                          of gastrointestinal      to provide 0.1
                                                          roundworms (Ascaris      milligrams per
                                                          suum, adults and         kilograms (mg/kg)
                                                          fourth-stage larvae;     of body weight per
                                                          Ascarops strongylina,    day. Withdraw 5
                                                          adults; Hyostrongylus    days before
                                                          rubidus, adults and      slaughter.
                                                          fourth-stage larvae;
                                                          Oesophagostomum spp.,
                                                          adults and fourth-
                                                          stage larvae);
                                                          kidneyworms
                                                          (Stephanurus dentatus,
                                                          adults and fourth-
                                                          stage larvae);
                                                          lungworms
                                                          (Metastrongylus spp.,
                                                          adults); threadworms
                                                          (Strongyloides
                                                          ransomi, adults and
                                                          somatic larvae); lice
                                                          (Haematopinus suis);
                                                          and mange mites
                                                          (Sarcoptes scabiei
                                                          var. suis).
(2) 1.8..........................  Bacitracin            Weaned, growing-         Feed as the only        000010
                                    methylenedisalicyla   finishing swine: For     feed for 7
                                    te, 10 to 30.         treatment and control    consecutive days
                                                          of gastrointestinal      to provide 0.1 mg/
                                                          roundworms (Ascaris      kg of body weight
                                                          suum, adults and         per day. Withdraw
                                                          fourth-stage larvae;     5 days before
                                                          Ascarops strongylina,    slaughter.
                                                          adults; Hyostrongylus
                                                          rubidus, adults and
                                                          fourth-stage larvae;
                                                          Oesophagostomum spp.,
                                                          adults and fourth-
                                                          stage larvae);
                                                          kidneyworms
                                                          (Stephanurus dentatus,
                                                          adults and fourth-
                                                          stage larvae);
                                                          lungworms
                                                          (Metastrongylus spp.,
                                                          adults); threadworms
                                                          (Strongyloides
                                                          ransomi, adults and
                                                          somatic larvae); lice
                                                          (Haematopinus suis);
                                                          and mange mites
                                                          (Sarcoptes scabieivar.
                                                          suis); and for
                                                          increased rate of
                                                          weight gain and
                                                          improved feed
                                                          efficiency.
(3) 1.8..........................  Bacitracin            Weaned, growing-         Feed as the only        000010
                                    methylenedisalicyla   finishing swine: For     feed for 7
                                    te, 250.              treatment and control    consecutive days
                                                          of gastrointestinal      to provide 0.1 mg/
                                                          roundworms (Ascaris      kg of body weight
                                                          suum, adults and         per day. Withdraw
                                                          fourth-stage larvae;     5 days before
                                                          Ascarops strongylina,    slaughter.
                                                          adults; Hyostrongylus
                                                          rubidus, adults and
                                                          fourth-stage larvae;
                                                          Oesophagostomum spp.,
                                                          adults and fourth-
                                                          stage larvae);
                                                          kidneyworms
                                                          (Stephanurus dentatus,
                                                          adults and fourth-
                                                          stage larvae);
                                                          lungworms
                                                          (Metastrongylus spp.,
                                                          adults); threadworms
                                                          (Strongyloides
                                                          ransomi, adults and
                                                          somatic larvae); lice
                                                          (Haematopinus suis);
                                                          and mange mites
                                                          (Sarcoptes scabiei
                                                          var. suis); and for
                                                          control of swine
                                                          dysentery associated
                                                          with Treponema
                                                          hyodysenteriae on
                                                          premises with a
                                                          history of swine
                                                          dysentery, but where
                                                          symptoms have not yet
                                                          occurred, or following
                                                          an approved treatment
                                                          of disease condition.

[[Page 465]]

 
(4) 1.8 to 11.8..................                        Adult and breeding       Feed as the only        000010
                                                          swine: For treatment     feed for 7
                                                          and control of           consecutive days
                                                          gastrointestinal         to provide 0.1 mg/
                                                          roundworms (Ascaris      kg of body weight
                                                          suum, adults and         per day. Withdraw
                                                          fourth-stage larvae;     5 days before
                                                          Ascarops strongylina,    slaughter.
                                                          adults; Hyostrongylus
                                                          rubidus, adults and
                                                          fourth-stage larvae;
                                                          Oesophagostomum spp.,
                                                          adults and fourth-
                                                          stage larvae);
                                                          kidneyworms
                                                          (Stephanurus dentatus,
                                                          adults and fourth-
                                                          stage larvae);
                                                          lungworms
                                                          (Metastrongylus spp.,
                                                          adults); threadworms
                                                          (Strongyloides
                                                          ransomi, adults and
                                                          somatic larvae, and
                                                          prevention of
                                                          transmission of
                                                          infective larvae to
                                                          piglets, via the
                                                          colostrum or milk,
                                                          when fed during
                                                          gestation); lice
                                                          (Haematopinus suis);
                                                          and mange mites
                                                          (Sarcoptes scabiei
                                                          var. suis).
(5) 1.8 to 11.8..................  Bacitracin            Pregnant sows: For       Feed as the only        000010
                                    methylenedisalicyla   treatment and control    feed for 7
                                    te, 250.              of gastrointestinal      consecutive days
                                                          roundworms (Ascaris      to provide 0.1 mg/
                                                          suum, adults and         kg of body weight
                                                          fourth-stage larvae;     per day. Withdraw
                                                          Ascarops strongylina,    5 days before
                                                          adults; Hyostrongylus    slaughter. Feed
                                                          rubidus, adults and      bacitracin
                                                          fourth-stage larvae;     methylenedisalicyl
                                                          Oesophagostomum spp.,    ate Type C
                                                          adults and fourth-       medicated feed to
                                                          stage larvae);           sows from 14 days
                                                          kidneyworms              before through 21
                                                          (Stephanurus dentatus,   days after
                                                          adults and fourth-       farrowing on
                                                          stage larvae);           premises with a
                                                          lungworms                history of
                                                          (Metastrongylus spp.,    clostridial scours.
                                                          adults); threadworms
                                                          (Strongyloides
                                                          ransomi, adults and
                                                          somatic larvae, and
                                                          prevention of
                                                          transmission of
                                                          infective larvae to
                                                          piglets, via the
                                                          colostrum or milk,
                                                          when fed during
                                                          gestation); lice
                                                          (Haematopinus suis);
                                                          and mange mites
                                                          (Sarcoptes scabiei
                                                          var. suis); and for
                                                          control of clostridial
                                                          enteritis caused by
                                                          Clostridium
                                                          perfringens in
                                                          suckling piglets.
(6) 18.2 to 120..................                        Adult and breeding       Top dress on daily      000010
                                                          swine: For treatment     ration for
                                                          and control of           individual
                                                          gastrointestinal         treatment for 7
                                                          roundworms (Ascaris      consecutive days
                                                          suum, adults and         to provide 0.1 mg/
                                                          fourth-stage larvae;     kg of body weight
                                                          Ascarops strongylina,    per day. Withdraw
                                                          adults; Hyostrongylus    5 days before
                                                          rubidus, adults and      slaughter.
                                                          fourth-stage larvae;
                                                          Oesophagostomum spp.,
                                                          adults and fourth-
                                                          stage larvae);
                                                          kidneyworms
                                                          (Stephanurus dentatus,
                                                          adults and fourth-
                                                          stage larvae);
                                                          lungworms
                                                          (Metastrongylus spp.,
                                                          adults); threadworms
                                                          (Strongyloides
                                                          ransomi, adults and
                                                          somatic larvae, and
                                                          prevention of
                                                          transmission of
                                                          infective larvae to
                                                          piglets, via the
                                                          colostrum or milk,
                                                          when fed during
                                                          gestation); lice
                                                          (Haematopinus suis);
                                                          and mange mites
                                                          (Sarcoptes scabiei
                                                          var. suis).
----------------------------------------------------------------------------------------------------------------


[72 FR 37437, July 10, 2007, as amended at 81 FR 17609, Mar. 30, 2016; 
81 FR 95005, Dec. 27, 2016; 84 FR 12499, Apr. 2, 2019; 84 FR 39185, Aug. 
9, 2019]



Sec. 558.305  Laidlomycin.

    (a) Specifications. Type A medicated articles containing 50 grams 
laidlomycin propionate potassium per pound.
    (b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.

[[Page 466]]

    (c) Tolerances. See Sec. 556.346 of this chapter.
    (d) Special considerations. (1) Laidlomycin liquid Type B feeds may 
be manufactured from dry laidlomycin Type A articles. The liquid Type B 
feeds must have a pH of 6.0 to 8.0, dry matter of 62 to 75 percent, and 
bear appropriate mixing directions as follows:
    (i) For liquid feeds stored in recirculating tank systems: 
Recirculate immediately prior to use for no less than 10 minutes, moving 
not less than 1 percent of the tank contents per minute from the bottom 
of the tank to the top. Recirculate daily as described even when not 
used.
    (ii) For liquid feeds stored in mechanical, air, or other agitation 
type tank systems: Agitate immediately prior to use for not less than 10 
minutes, creating a turbulence at the bottom of the tank that is visible 
at the top. Agitate daily as described even when not used.
    (2) The expiration date for the liquid Type B feed is 21 days after 
date of manufacture. The expiration date for the dry Type C feed made 
from the liquid Type B feed is 7 days after date of manufacture.
    (3) Labeling for all Type B feeds (liquid and dry) and Type C feeds 
containing laidlomycin shall bear the following statements:
    (i) Do not allow horses or other equines access to feeds containing 
laidlomycin propionate potassium.
    (ii) The safety of laidlomycin propionate potassium in unapproved 
species has not been established.
    (iii) Not for use in animals intended for breeding.
    (e) Conditions of use. It is used in cattle being fed in confinement 
for slaughter as follows:

----------------------------------------------------------------------------------------------------------------
                                   Combination in grams
   Laidlomycin in grams per ton           per ton          Indications for use        Limitations       Sponsor
----------------------------------------------------------------------------------------------------------------
(1) 5............................  ....................  For improved feed        Feed continuously       054771
                                                          efficiency and           in a Type C feed
                                                          increased rate of        at a rate of 30 to
                                                          weight gain..            75 mg/head/day..
(2) 5 to 10......................  ....................  For improved feed        Feed continuously       054771
                                                          efficiency..             in a Type C feed
                                                                                   at a rate of 30 to
                                                                                   150 milligrams/
                                                                                   head/day..
----------------------------------------------------------------------------------------------------------------

    (f) Laidlomycin may also be used in combination with 
chlortetracycline as in Sec. 558.128.

[59 FR 18297, Apr. 18, 1994, as amended at 60 FR 53509, Oct. 16, 1995; 
62 FR 9929, Mar. 5, 1997; 63 FR 27845, May 21, 1998; 66 FR 46706, Sept. 
7, 2001; 68 FR 13839, Mar. 21, 2003; 68 FR 42590, July 18, 2003; 69 FR 
30198, May 27, 2004; 79 FR 13545, Mar. 11, 2014; 81 FR 95005, Dec. 27, 
2016; 86 FR 14823, Mar. 19, 2021]



Sec. 558.311  Lasalocid.

    (a) Specifications. Each pound of Type A medicated article contains 
68 grams (15 percent), 90.7 grams (20 percent), or 150 grams (33.1 
percent) lasalocid as lasalocid sodium activity. A minimum of 90 percent 
of lasalocid activity is derived from lasalocid A.
    (b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
    (c) Related tolerance. See Sec. 556.347 of this chapter.
    (d) Special considerations. (1) Type C cattle and sheep feeds may be 
manufactured from lasalocid liquid Type B feeds which have a pH of 4.0 
to 8.0 and bear appropriate mixing directions as follows:
    (i) For liquid feeds stored in recirculating tank systems: 
Recirculate immediately prior to use for no less than 10 minutes, moving 
not less than 1 percent of the tank contents per minute from the bottom 
of the tank to the top. Recirculate daily as described even when not 
used.
    (ii) For liquid feeds stored in mechanical, air, or other agitation-
type tank systems: Agitate immediately prior to use for not less than 10 
minutes, creating a turbulence at the bottom of the tank that is visible 
at the top. Agitate daily as described even when not used.
    (2) A physically stable lasalocid liquid feed will not be subject to 
the requirements for mixing directions prescribed in paragraph (d)(1) of 
this section provided it has a pH of 4.0 to 8.0 and contains a 
suspending agent(s) sufficient to maintain a viscosity of not

[[Page 467]]

less than 300 centipoises per second for 3 months.
    (3) If a manufacturer is unable to meet the requirements of 
paragraph (d)(1) or (d)(2) of this section, the manufacturer may secure 
approval of a positionally stable liquid feed by:
    (i) Either filing a new animal drug application for the product or 
establishing a master file containing data to support the stability of 
its product;
    (ii) Authorizing the agency to reference and rely upon the data in 
the master file to support approval of a supplemental new animal drug 
application to establish physical stability; and
    (iii) Requesting the sponsor of an approved new animal drug 
application to file a supplement to provide for use of its lasalocid 
Type A article in the manufacture of the liquid feed specified in the 
appropriate master file. If the data demonstrate the stability of the 
liquid feed described in the master file, the supplemental new animal 
drug application will be approved. The approval will provide a basis for 
the individual liquid feed manufacturer to manufacture under a medicated 
feed license the liquid mediated feed described in the master file. A 
manufacturer who seeks to market a physically unstable lasalocid liquid 
feed with mixing directions different from the standard directions 
established in paragraph (d)(1) of this section may also follow this 
procedure.
    (4) If adequate information is submitted to show that a particular 
liquid feed containing lasalocid is stable outside the pH of 4.0 to 8.0, 
the pH restriction described in paragraphs (d)(1) and (d)(2) of this 
section may be waived.
    (5) Required label statements:
    (i) For liquid Type B feed (cattle and sheep): Mix thoroughly with 
grain and/or roughage prior to feeding. Feeding undiluted, mixing 
errors, or inadequate mixing (recirculation or agitation) may result in 
an excess lasalocid concentration which could be fatal to cattle and 
sheep. Do not allow horses or other equines access to Type A articles or 
Type B feeds containing lasalocid as ingestion may be fatal. Safety of 
lasalocid for use in unapproved species has not been established.
    (ii) For Type A articles or Type B feeds (cattle and sheep): Feeding 
undiluted or mixing errors may result in an excess lasalocid 
concentration which could be fatal to cattle and sheep. Do not allow 
horses or other equines access to Type A articles or Type B feeds 
containing lasalocid as ingestion may be fatal. Safety of lasalocid for 
use in unapproved species has not been established.
    (iii) For Type A articles, Type B or Type C feeds (cattle): A 
withdrawal period has not been established for this product in 
preruminating calves. Do not use in calves to be processed for veal.
    (6) Lasalocid Type A medicated articles containing lasalocid dried 
fermentation residue are for use in cattle and sheep feed only.
    (7) Each use in a free-choice Type C cattle feed as in paragraphs 
(e)(3)(vi) through (e)(3)(viii) of this section must be the subject of 
an approved NADA or supplemental NADA as provided in Sec. 510.455 of 
this chapter.
    (e) Conditions of use. It is used as follows:
    (1) The conditions of use for chickens are:

----------------------------------------------------------------------------------------------------------------
                                      Combination in
      Lasalocid in grams/ton            grams/ton         Indications for use       Limitations        Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 68 to 113....................  ...................  Broiler or fryer        Feed continuously         054771
                                                         chickens: For           as the sole
                                                         prevention of           ration..
                                                         coccidiosis caused by
                                                         Eimeria tenella, E.
                                                         necatrix, E.
                                                         acervulina, E.
                                                         brunetti, E. mivati,
                                                         and E. maxima..
(ii) 68..........................  Bacitracin           Broiler chickens: For   Feed continuously         054771
                                    methylenedisalicyl   prevention of           as the sole
                                    ate, 10 to 50.       coccidiosis caused by   ration. Bacitracin
                                                         Eimeria tenella, E.     methylenedisalicyl
                                                         necatrix, E.            ate provided by
                                                         acervulina, E.          No. 054771 in Sec.
                                                         brunetti, E. mivati,      510.600(c) of
                                                         and E. maxima; and      this chapter..
                                                         for increased rate of
                                                         weight gain and
                                                         improved feed
                                                         efficiency..

[[Page 468]]

 
(iii) 68 to 113..................  Bacitracin           Broiler chickens: For   Feed continuously         054771
                                    methylenedisalicyl   prevention of           as the sole
                                    ate, 4 to 50.        coccidiosis caused by   ration. Bacitracin
                                                         Eimeria tenella, E.     methylenedisalicyl
                                                         necatrix, E.            ate provided by
                                                         acervulina, E.          No. 054771 in Sec.
                                                         brunetti, E. mivati,      510.600(c) of
                                                         and E. maxima; and      this chapter..
                                                         for improved feed
                                                         efficiency..
(iv) 68 to 113...................  Bacitracin zinc, 4   Broiler chickens. For   Feed continuously         054771
                                    to 50.               prevention of           as the sole
                                                         coccidiosis caused by   ration. Bacitracin
                                                         Eimeria tenella, E.     zinc provided by
                                                         necatrix, E.            No. 054771 in Sec.
                                                         acervulina, E.            510.600(c) of
                                                         brunetti, E. mivati,    this chapter..
                                                         and E. maxima; and
                                                         for increased rate of
                                                         weight gain and
                                                         improved feed
                                                         efficiency..
(v) 68 to 113....................  Bambermycins, 1 to   Broiler chickens: For   Feed continuously         016592
                                    2.                   prevention of           as sole ration.
                                                         coccidiosis caused by   Bambermycins
                                                         Eimeria tenella, E.     provided by No.
                                                         necatrix, E.            016592 in Sec.
                                                         acervulina, E.          510.600(c) of this
                                                         brunetti, E. mivati,    chapter..
                                                         and E. maxima; and
                                                         for increased rate of
                                                         weight gain and
                                                         improved feed
                                                         efficiency..
----------------------------------------------------------------------------------------------------------------

    (2) The conditions of use for turkeys are:

----------------------------------------------------------------------------------------------------------------
                                      Combination in
      Lasalocid in grams/ton            grams/ton         Indications for use       Limitations        Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 68 to 113....................  ...................  Growing turkeys; For    Feed continuously         054771
                                                         prevention of           as sole ration..
                                                         coccidiosis caused by
                                                         Eimeria
                                                         meleagrimitis, E.
                                                         gallopavonis, and E.
                                                         adenoeides..
(ii) 68 to 113...................  Bacitracin           Growing turkeys: For    Feed continuously         054771
                                    methylenedisalicyl   prevention of           as the sole
                                    ate, 4 to 50.        coccidiosis caused by   ration. Bacitracin
                                                         E. meleagrimitis, E.    methylenedisalicyl
                                                         gallopavonis, and E.    ate as provided by
                                                         adenoeides; and for     No. 054771 in Sec.
                                                         increased rate of         510.600(c) in
                                                         weight gain and         this chapter..
                                                         improved feed
                                                         efficiency..
(iii) 68 to 113..................  Bacitracin zinc, 4   Growing turkeys: For    Feed continuously         054771
                                    to 50.               prevention of           as the sole
                                                         coccidiosis caused by   ration. Bacitracin
                                                         E. meleagrimitis, E.    zinc as provided
                                                         gallopavonis, and E.    by No. 054771 in
                                                         adenoeides; and for     Sec. 510.600(c)
                                                         increased rate of       in this chapter..
                                                         weight gain and
                                                         improved feed
                                                         efficiency..
----------------------------------------------------------------------------------------------------------------

    (3) The conditions of use for cattle are--

----------------------------------------------------------------------------------------------------------------
            Lasalocid amount                 Indications for use               Limitations             Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 10 to 30 grams/ton of feed.........  Cattle fed in confinement   Feed continuously in complete        054771
                                          for slaughter: For          feed to provide not less than
                                          improved feed efficiency..  100 milligrams (mg) nor more
                                                                      than 360 mg of lasalocid
                                                                      sodium activity per head per
                                                                      day..
(ii) 25 to 30 grams/ton of feed........  Cattle fed in confinement   Feed continuously in complete        054771
                                          for slaughter: For          feed to provide not less than
                                          improved feed efficiency    250 mg nor more than 360 mg
                                          and increased rate of       of lasalocid sodium activity
                                          weight gain..               per head per day..
(iii) Not less than 60 mg or more than   Pasture cattle (slaughter,  Feed continuously at a rate of       054771
 300 mg of lasalocid per head per day.    stocker, feeder cattle,     not less than 60 mg or more
                                          and dairy and beef          than 300 mg of lasalocid per
                                          replacement heifers): For   head per day when on pasture.
                                          increased rate of weight    The drug must be contained in
                                          gain..                      at least 1 pound of feed.
                                                                      Daily intakes of lasalocid in
                                                                      excess of 200 mg/head/day
                                                                      have not been shown to be
                                                                      more effective than 200 mg/
                                                                      head/day..

[[Page 469]]

 
(iv) 1 mg lasalocid per 2.2 pounds (lb)  Cattle up to 800 lb: For    Hand feed continuously at a          054771
 body weight per day.                     control of coccidiosis      rate of 1 mg of lasalocid per
                                          caused by Eimeria bovis     2.2 lb body weight per day to
                                          and E. zuernii..            provide not more than 360 mg
                                                                      of lasalocid per head per
                                                                      day..
(v) 1 mg lasalocid per 2.2 lb body       Replacement calves: For     In milk replacer powder, hand        054771
 weight per day.                          control of coccidiosis      feed at a rate of 1 mg of
                                          caused by E. bovis and E.   lasalocid per 2.2 lb body
                                          zuernii..                   weight per day. A withdrawal
                                                                      period has not been
                                                                      established for lasalocid in
                                                                      pre-ruminating calves. Do not
                                                                      use in calves to be processed
                                                                      for veal..
(vi) 1,440 grams/ton...................  Pasture cattle (slaughter,  As a free-choice Type C              012286
                                          stocker, feeder cattle,     medicated loose mineral, feed
                                          and dairy and beef          continuously at a rate of not
                                          replacement heifers): For   less than 60 mg nor more than
                                          increased rate of weight    200 mg of lasalocid per head
                                          gain..                      per day..
(vii) 1,440 grams/ton..................  Pasture cattle (slaughter,  As a free-choice Type C              017800
                                          stocker, feeder cattle,     medicated mineral block, feed
                                          and dairy and beef          continuously at a rate of not
                                          replacement heifers): For   less than 60 mg nor more than
                                          increased rate of weight    200 mg of lasalocid per head
                                          gain..                      per day..
(viii) 300 grams/ton...................  Pasture cattle (slaughter,  As a free-choice Type C              067949
                                          stocker, feeder cattle,     medicated protein block, feed
                                          and dairy and beef          continuously at a rate of not
                                          replacement heifers): for   less than 60 mg nor more than
                                          increased rate of weight    200 mg of lasalocid per head
                                          gain..                      per day..
----------------------------------------------------------------------------------------------------------------

    (4) The conditions of use for minor species are:

----------------------------------------------------------------------------------------------------------------
         Lasalocid in grams/ton              Indications for use               Limitations             Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 20 to 30...........................  Sheep maintained in         Feed continuously in complete        054771
                                          confinement: For            feed to provide not less than
                                          prevention of coccidiosis   15 milligrams (mg) nor more
                                          caused by Eimeria ovina,    than 70 mg of lasalocid
                                          E. crandallis, E.           sodium activity per head per
                                          ovinoidalis (E.             day depending on body weight..
                                          ninakohlyakimovae), E.
                                          parva, and E. intricata..
(ii) 113...............................  Chukar partridges: For      Feed continuously as sole            054771
                                          prevention of coccidiosis   ration up to 8 weeks of age..
                                          caused by E. legionensis..
(iii) 113..............................  Rabbits: For prevention of  Feed continuously as sole            054771
                                          coccidiosis caused by E.    ration up to 6 1/2 weeks of
                                          stiedae..                   age.
----------------------------------------------------------------------------------------------------------------

    (5) It is used as a free-choice mineral Type C feed as follows:
    (i) Specifications.

------------------------------------------------------------------------
            Ingredient               Percent    International feed No.
------------------------------------------------------------------------
Defluorinated phosphate (20.5% Ca,     35.9   6-01-080
 18.5% P).
Sodium chloride (salt)............     20.0   6-04-152
Calcium carbonate (38% Ca)........     18.0   6-01-069
Cottonseed meal...................     10.0   5-01-621
Potassium chloride................      3.0   6-03-755
Selenium premix (0.02 percent           3.0   ..........................
 Se)\1\.
Dried cane molasses (46% sugars)..      2.5   4-04-695
Magnesium sulfate.................      1.7   6-02-758
Vitamin premix\1\.................      1.4   ..........................
Magnesium oxide (58% Mg)..........      1.2   6-02-756
Potassium sulfate.................      1.2   6-06-098
Trace mineral premix\1\...........      1.04  ..........................
Lasalocid Type A medicated article      1.06  ..........................
 (68 g/lb)\2\.
------------------------------------------------------------------------
\1\ Content of the vitamin and trace mineral premixes may be varied;
  however, they should be comparable to those used by the firm for other
  free-choice feeds. Formulation modifications require FDA approval
  prior to marketing. Selenium must comply with 21 CFR 573.920.
  Ethylenediamine dihydroiodide (EDDI) should comply with FDA Compliance
  Policy Guides Sec. 651.100 (CPG 7125.18).
\2\ To provide 1,440 g lasalocid per ton, use 21.2 lbs (1.06%) of a
  lasalocid Type A medicated article containing 68 g/lb. If using a
  lasalocid Type A medicated article containing 90.7 g/lb, use 15.88 lbs
  per ton (0.794%), adding molasses.


[[Page 470]]

    (ii) Amount. 1,440 grams per ton.
    (iii) Indications for use. Pasture cattle (slaughter, stocker, 
feeder cattle, and dairy and beef replacement heifers): for increased 
rate of weight gain. Intakes of lasalocid in excess of 200 mg/head/day 
have not been shown to be more effective than 200 mg/head/day.
    (iv) Limitations. For pasture cattle (slaughter, stocker, feeder 
cattle, and dairy and beef replacement heifers); feed continuously on a 
free-choice basis at a rate of 60 to 300 milligrams lasalocid per head 
per day.
    (v) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
    (6) It is used as a ruminant free-choice liquid Type C feed as 
follows:
    (i) Specifications.

------------------------------------------------------------------------
            Ingredient               Percent     International feed No.
------------------------------------------------------------------------
Cane molasses....................      55.167  4-13-241
Condensed molasses fermentation        24.0    .........................
 solubles.
50% Urea Solution (23% N)........      12.0    .........................
Ammonium polyphosphate solution..       1.0    6-08-42
Phosphoric acid (54%)............       3.0    6-03-707
Xanthan gum......................       0.05   8-15-818
Water............................       4.0    .........................
Trace mineral premix\1\..........       0.5    .........................
Vitamin premix\1\................       0.2    .........................
Lasalocid liquid Type A medicated       0.083  .........................
 article (90.7 g/lb)\2\.
------------------------------------------------------------------------
\1\ Content of the vitamin and trace mineral premixes may be varied;
  however, they should be comparable to those used by the firm for other
  free-choice feeds. Formulation modifications require FDA approval
  prior to marketing. Selenium must comply with 21 CFR 573.920.
  Ethylenediamine dihydroiodide (EDDI) should comply with FDA Compliance
  Policy Guides Sec. 651.100 (CPG 7125.18).
\2\ To provide 150 gm lasalocid per ton, use 1.652 lb (0.083%) of a
  lasalocid liquid Type A medicated article containing 90.7 g/lb. If
  using a dry lasalocid Type A medicated article containing 68 g/lb,
  use, use 2.206 lbs per ton (0.111%), replacing molasses. If using a
  dry lasalocid Type A medicated article containing 90.7 g/lb, use 1.652
  lbs per ton (0.083%), adding molasses.

    (ii) Amount. 150 grams per ton.
    (iii) Indications for use. Pasture cattle (slaughter, stocker, 
feeder cattle, and dairy and beef replacement heifers): for increased 
rate of weight gain. Intakes of lasalocid in excess of 200 mg/head/day 
have not been shown to be more effective than 200 mg/head/day.
    (iv) Limitations. For pasture cattle (slaughter, stocker, feeder 
cattle, and dairy and beef replacement heifers). Feed continuously on a 
free-choice basis at a rate of 60 to 300 milligrams lasalocid per head 
per day.
    (v) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
    (7) It is used as a free-choice, loose mineral Type C feed as 
follows:
    (i) Specifications.

------------------------------------------------------------------------
            Ingredient               Percent    International feed No.
------------------------------------------------------------------------
Monocalcium phosphate (21% P).....    57.70   6-01-082
Salt..............................    17.55   6-04-152
Distillers dried grains w/             5.40   5-28-236
 solubles.
Dried cane molasses (46% Sugars)..     5.20   4-04-695
Potassium chloride................     4.90   6-03-755
Trace mineral/vitamin premix\1\...     3.35   ..........................
Calcium carbonate (38% Ca)........     2.95   6-01-069
Mineral oil.......................     1.05   8-03-123
Magnesium oxide (58% Mg)..........     1.00   6-02-756
Iron oxide (52% Fe)...............     0.10   6-02-431
Lasalocid Type A medicated article     0.80   ..........................
 (68 g/lb)\2\.
------------------------------------------------------------------------
\1\ Content of the vitamin and trace mineral premixes may be varied;
  however, they should be comparable to those used by the firm for other
  free-choice feeds. Formulation modifications require FDA approval
  prior to marketing. Selenium must comply with 21 CFR 573.920.
  Ethylenediamine dihydroiodide (EDDI) should comply with FDA Compliance
  Policy Guides Sec. 651.100 (CPG 7125.18).
\2\ To provide 1,088 g lasalocid per ton, use 16 lbs (0.80%) of a
  lasalocid Type A medicated article containing 68 g/lb. If using a
  lasalocid Type A medicated article containing 90.7 g/lb, use 12 lbs
  per ton (0.6%), adding molasses.

    (ii) Amount. 1,088 grams per ton.
    (iii) Indications for use. Pasture cattle (slaughter, stocker, 
feeder cattle, and dairy and beef replacement heifers): For increased 
rate of weight gain. Intakes of lasalocid in excess of 200 mg/head/day 
have not been shown to be more effective than 200 mg/head/day.

[[Page 471]]

    (iv) Limitations. Feed continuously on a free-choice basis at a rate 
of 60 to 300 mg lasalocid per head per day.
    (v) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
    (8) Lasalocid may also be used in combination with:
    (i) Chlortetracycline as in Sec. 558.128.
    (ii) Chlortetracycline and sulfa methazine as in Sec. 558.140.
    (iii) Lincomycin as in Sec. 558.325.
    (iv) Melengestrol as in Sec. 558.342.
    (v) Oxytetracycline as in Sec. 558.450.
    (vi) Tylosin alone or in combination with melengestrol acetate as in 
Sec. 558.625.
    (vii) Virginiamycin as in Sec. 558.635.

[41 FR 44382, Oct. 8, 1976]

    Editorial Notes: 1. For Federal Register citations affecting Sec. 
558.311, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and at www.govinfo.gov.

    2. At 79 FR 13545, Mar. 11, 2014, Sec. 558.311 was amended; 
however, the amendment could not be incorporated because of the 
inaccurate amendatory instruction.



Sec. 558.325  Lincomycin.

    (a) Specifications. Type A medicated articles containing 20 or 50 
grams of lincomycin (as lincomycin hydrochloride) per pound.
    (b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
    (c) Related tolerances. See Sec. 556.360 of this chapter.
    (d) Special considerations. (1) Federal law restricts medicated feed 
containing this veterinary feed directive (VFD) drug to use by or on the 
order of a licensed veterinarian. See Sec. 558.6 for additional 
requirements.
    (2) The expiration date of VFDs for lincomycin medicated feeds must 
not exceed 6 months from the date of issuance. VFDs for lincomycin shall 
not be refilled.
    (3) Labeling of Type A medicated articles and Type B and Type C 
medicated feeds containing lincomycin shall bear the following:
    (i) ``CAUTION: Do not allow rabbits, hamsters, guinea pigs, horses, 
or ruminants access to feeds containing lincomycin. Ingestion by these 
species may result in severe gastrointestinal effects.''
    (ii) [Reserved]
    (4) Labeling of medicated feeds containing lincomycin intended for 
use in swine shall bear the following:
    (i) ``CAUTION: Occasionally, swine fed lincomycin may within the 
first 2 days after the onset of treatment develop diarrhea and/or 
swelling of the anus. On rare occasions, some pigs may show reddening of 
the skin and irritable behavior. These conditions have been self-
correcting within 5 to 8 days without discontinuing the lincomycin 
treatment.''
    (ii) ``CAUTION: The effects of lincomycin on swine reproductive 
performance, pregnancy, and lactation have not been determined.''
    (e) Conditions of use--(1) Chickens--

----------------------------------------------------------------------------------------------------------------
                                     Combination in
      Lincomycin grams/ton             grams/ton        Indications for use      Limitations         Sponsors
----------------------------------------------------------------------------------------------------------------
(i) 2...........................  ...................  Broilers: For the     Feed as the sole             054771
                                                        control of necrotic   ration. Not for
                                                        enteritis caused or   use in layers,
                                                        complicated by        breeders, or
                                                        Clostridium spp. or   turkeys.
                                                        other organisms
                                                        susceptible to
                                                        lincomycin.
(ii) [Reserved]
(iii) 2.........................  Clopidol, 113.5....  Broiler chickens:     Feed as the sole             054771
                                                        For the control of    ration to broiler
                                                        necrotic enteritis    chickens. Do not
                                                        caused or             feed to chickens
                                                        complicated by        over 16 weeks of
                                                        Clostridium spp. or   age. Not for use
                                                        other organisms       in laying hens,
                                                        susceptible to        breeding chickens,
                                                        lincomycin, and as    or turkeys. Do not
                                                        an aid in the         allow rabbits,
                                                        prevention of cecal   hamsters, guinea
                                                        and intestinal        pigs, horses, or
                                                        coccidiosis caused    ruminants access
                                                        by Eimeria tenella,   to feeds
                                                        E. necatrix, E.       containing
                                                        acervulina, E.        lincomycin.
                                                        maxima, E.            Ingestion by these
                                                        brunetti, and E.      species may result
                                                        mivati.               in severe
                                                                              gastrointestinal
                                                                              effects. Clopidol
                                                                              as provided by No.
                                                                              016592 in Sec.
                                                                              510.600 of this
                                                                              chapter.

[[Page 472]]

 
(iv) 2..........................  Decoquinate, 27.2..  Broiler chickens:     Feed as the sole             054771
                                                        For the control of    ration. Do not use
                                                        necrotic enteritis    in feeds
                                                        caused or             containing
                                                        complicated by        bentonite. Not for
                                                        Clostridium spp. or   use in laying
                                                        other organisms       hens, breeding
                                                        susceptible to        chickens, or
                                                        lincomycin; and for   turkeys. Do not
                                                        the prevention of     allow rabbits,
                                                        coccidiosis caused    hamsters, guinea
                                                        by Eimeria tenella,   pigs, horses, or
                                                        E. necatrix, E.       ruminants access
                                                        acervulina, E.        to feeds
                                                        brunetti, E.          containing
                                                        mivati, and E.        lincomycin.
                                                        maxima.               Ingestion by these
                                                                              species may result
                                                                              in severe
                                                                              gastrointestinal
                                                                              effects.
                                                                              Decoquinate as
                                                                              provided by No.
                                                                              054771 in Sec.
                                                                              510.600 of this
                                                                              chapter.
(v) 2...........................  Halofuginone 2.72..  Broiler chickens:     Feed continuously            016592
                                                        For the control of    as sole ration.
                                                        necrotic enteritis    Withdraw 4 days
                                                        caused or             before slaughter.
                                                        complicated by        Do not feed to
                                                        Clostridium spp. or   laying chickens or
                                                        other organisms       waterfowl.
                                                        susceptible to        Halofuginone
                                                        lincomycin; and the   hydrobromide as
                                                        prevention of         provided by No.
                                                        coccidiosis caused    016592 in Sec.
                                                        by Eimeria tenella,   510.600 of this
                                                        E. necatrix, E.       chapter.
                                                        acervulina, E.
                                                        brunetti, E.
                                                        mivati, and E.
                                                        maxima.
(vi) 2..........................  Lasalocid, 68 to     Broiler chickens:     Feed as the sole             054771
                                   113.                 For the control of    ration. Type C
                                                        necrotic enteritis    feed must be used
                                                        caused or             within 4 weeks of
                                                        complicated by        manufacture. Not
                                                        Clostridium spp. or   for use in laying
                                                        other organisms       hens, breeding
                                                        susceptible to        chickens, or
                                                        lincomycin, and for   turkeys. Do not
                                                        the prevention of     allow rabbits,
                                                        coccidiosis caused    hamsters, guinea
                                                        by Eimeria tenella,   pigs, horses, or
                                                        E. necatrix, E.       ruminants access
                                                        acervulina, E.        to feeds
                                                        brunetti, E.          containing
                                                        mivati, and E         lincomycin.
                                                        maxima.               Ingestion by these
                                                                              species may result
                                                                              in severe
                                                                              gastrointestinal
                                                                              effects. Lasalocid
                                                                              as provided by No.
                                                                              054771 in Sec.
                                                                              510.600 of this
                                                                              chapter.
(vii) 2.........................  Monensin, 90 to 110  Broiler chickens:     Feed as the sole             054771
                                                        For the control of    ration. Must be
                                                        necrotic enteritis    thoroughly mixed
                                                        caused or             in feeds before
                                                        complicated by        use. Do not feed
                                                        Clostridium spp. or   undiluted. Not for
                                                        other organisms       use in laying
                                                        susceptible to        hens, breeding
                                                        lincomycin, and as    chickens, or
                                                        an aid the            turkeys. Do not
                                                        prevention of         allow horses, or
                                                        coccidiosis caused    other equines,
                                                        by Eimeria            mature turkeys, or
                                                        necatrix, E.          guinea fowl access
                                                        tenella, E.           to feed containing
                                                        acervulina, E.        monensin.
                                                        brunetti, E.          Ingestion of
                                                        mivati, and E.        monensin by horses
                                                        maxima.               and guinea fowl
                                                                              has been fatal. Do
                                                                              not allow rabbits,
                                                                              hamsters, guinea
                                                                              pigs, horses, or
                                                                              ruminants access
                                                                              to feeds
                                                                              containing
                                                                              lincomycin.
                                                                              Ingestion by these
                                                                              species may result
                                                                              in severe
                                                                              gastrointestinal
                                                                              effects. Monensin
                                                                              as provided by No.
                                                                              058198 in Sec.
                                                                              510.600 of this
                                                                              chapter.

[[Page 473]]

 
(viii) 2........................  Robenidine           Broiler chickens:     Feed as the sole             054771
                                   hydrochloride, 30.   For the control of    ration. Do not use
                                                        necrotic enteritis    in feeds
                                                        caused or             containing
                                                        complicated by        bentonite. Do not
                                                        Clostridium spp. or   feed to laying
                                                        other organisms       hens producing
                                                        susceptible to        eggs for human
                                                        lincomycin, and as    consumption. Not
                                                        an aid in the         for use in laying
                                                        prevention of         hens, breeding
                                                        coccidiosis caused    chickens, or
                                                        by Eimeria mivati,    turkeys. Do not
                                                        E. brunetti, E.       allow rabbits,
                                                        tenella, E.           hamsters, guinea
                                                        acervulina, E.        pigs, horses, or
                                                        maxima, and E.        ruminants access
                                                        necatrix.             to feeds
                                                                              containing
                                                                              lincomycin.
                                                                              Ingestion by these
                                                                              species may result
                                                                              in severe
                                                                              gastrointestinal
                                                                              effects. Withdraw
                                                                              5 days prior to
                                                                              slaughter. Type C
                                                                              feed containing
                                                                              robenidine
                                                                              hydrochloride must
                                                                              be fed within 50
                                                                              days from the date
                                                                              of manufacture.
                                                                              Robenidine
                                                                              hydrochloride as
                                                                              provided by No.
                                                                              054771 in Sec.
                                                                              510.600 of this
                                                                              chapter.
(ix) 2..........................  Salinomycin, 40 to   Broiler chickens:     Feed as the sole              05477
                                   60.                  For the control of    ration to broiler
                                                        necrotic enteritis    chickens. Do not
                                                        caused or             feed to laying
                                                        complicated by        hens producing
                                                        Clostridium spp. or   eggs for human
                                                        other organisms       consumption. Not
                                                        susceptible to        approved for use
                                                        lincomycin, and for   with pellet
                                                        the prevention of     binders. May be
                                                        coccidiosis caused    fatal if
                                                        by Eimeria tenella,   accidentally fed
                                                        E. necatrix, E.       to adult turkeys
                                                        acervulina, E         or horses. Not for
                                                        maxima, E.            use in laying
                                                        brunetti, and E.      hens, breeding
                                                        mivati.               chickens, or
                                                                              turkeys. Do not
                                                                              allow rabbits,
                                                                              hamsters, guinea
                                                                              pigs, horses, or
                                                                              ruminants access
                                                                              to feeds
                                                                              containing
                                                                              lincomycin.
                                                                              Ingestion by these
                                                                              species may result
                                                                              in severe
                                                                              gastrointestinal
                                                                              effects.
                                                                              Salinomycin as
                                                                              provided by No.
                                                                              054771 in Sec.
                                                                              510.600 of this
                                                                              chapter.
(x) 2...........................  Zoalene, 113.5.....  Broiler chickens:     Feed as the sole             054771
                                                        For the control of    ration from the
                                                        necrotic enteritis    time chicks are
                                                        caused or             placed in floor
                                                        complicated by        pens until
                                                        Clostridium spp. or   slaughtered for
                                                        other organisms       meat. Not for use
                                                        susceptible to        in laying hens,
                                                        lincomycin; and for   breeding chickens,
                                                        the prevention and    or turkeys. Do not
                                                        control of            allow rabbits,
                                                        coccidiosis.          hamsters, guinea
                                                                              pigs, horses, or
                                                                              ruminants access
                                                                              to feeds
                                                                              containing
                                                                              lincomycin.
                                                                              Ingestion by these
                                                                              species may result
                                                                              in severe
                                                                              gastrointestinal
                                                                              effects. Zoalene
                                                                              as provided by No.
                                                                              054771 in Sec.
                                                                              510.600 of this
                                                                              chapter.
----------------------------------------------------------------------------------------------------------------

    (2) Swine--

----------------------------------------------------------------------------------------------------------------
                                     Combination in
      Lincomycin grams/ton             grams/ton        Indications for use      Limitations         Sponsors
----------------------------------------------------------------------------------------------------------------
(i) 40..........................  ...................  For control of swine  Feed as sole                 054771
                                                        dysentery and the     ration. For use in
                                                        control of porcine    swine on premises
                                                        proliferative         with a history of
                                                        enteropathies         swine dysentery
                                                        (ileitis) caused by   but where symptoms
                                                        Lawsonia              have not yet
                                                        intracellularis.      occurred, or
                                                                              following use of
                                                                              lincomycin at 100
                                                                              grams (g)/ton for
                                                                              the treatment of
                                                                              swine dysentery
                                                                              and the control of
                                                                              porcine
                                                                              proliferative
                                                                              enteropathies
                                                                              (ileitis).

[[Page 474]]

 
(ii) 40.........................  Fenbendazole, 10 to  For control of swine  Feed as sole ration          000061
                                   80.                  dysentery in          to provide a total
                                                        animals on premises   dose of 9 mg
                                                        with a history of     fenbendazole/kg of
                                                        swine dysentery,      body weight within
                                                        but where symptoms    3 to 12 days. Do
                                                        have not yet          not feed to swine
                                                        occurred; and for     that weigh more
                                                        the removal of:       than 250 pounds.
                                                        Adult stage           Lincomycin as
                                                        lungworms             provided by No.
                                                        (Metastrongylus       054771;
                                                        apri and M.           fenbendazole as
                                                        pudendotectus);       provided by No.
                                                        adult and larvae      000061 in Sec.
                                                        (L3, 4 stages--       510.600(c) of this
                                                        liver, lung,          chapter.
                                                        intestinal forms)
                                                        large roundworms
                                                        (Ascaris suum);
                                                        adult stage nodular
                                                        worms
                                                        (Oesophagostomum
                                                        dentatum, O.
                                                        quadrispinulatum);
                                                        adult stage small
                                                        stomach worms
                                                        (Hyostrongylus
                                                        rubidus); adult and
                                                        larvae (L2, 3, 4
                                                        stages--intestinal
                                                        mucosal forms)
                                                        whipworms
                                                        (Trichuris suis);
                                                        adult and larvae
                                                        kidney worms
                                                        (Stephanurus
                                                        dentatus).
(iii) 40........................  Pyrantel, 96.......  For control of swine  Feed as the sole             066104
                                                        dysentery on          ration. Not to be
                                                        premises with a       fed to swine that
                                                        history of swine      weigh more than
                                                        dysentery, but        250 pounds.
                                                        where symptoms have   Withdraw 6 days
                                                        not yet occurred;     prior to
                                                        as an aid in the      slaughter.
                                                        prevention of         Lincomycin as
                                                        migration and         provided by No.
                                                        establishment of      054771; pyrantel
                                                        large roundworm       as provided by No.
                                                        (Ascaris suum)        066104 in Sec.
                                                        infections; and as    510.600(c) of this
                                                        an aid in the         chapter.
                                                        prevention of
                                                        establishment of
                                                        nodular worm
                                                        (Oesophagostomum
                                                        spp.) infections.
(iv) 40.........................  Pyrantel, 96.......  For the treatment     Feed for 3 days as           066104
                                                        and/or control of     the sole ration.
                                                        swine dysentery;      Not to be fed to
                                                        for removal and       swine that weigh
                                                        control of large      more than 250
                                                        roundworm (Ascaris    pounds. Withdraw
                                                        suum) infections.     24 hours prior to
                                                                              slaughter.
                                                                              Lincomycin as
                                                                              provided by No.
                                                                              054771; pyrantel
                                                                              as provided by No.
                                                                              066104 in Sec.
                                                                              510.600(c) of this
                                                                              chapter.
(v) 40 or 100...................  Pyrantel, 96.......  For the treatment     For treatment of             066104
                                                        and/or control of     swine dysentery,
                                                        swine dysentery; as   feed 100 grams of
                                                        an aid in the         lincomycin and 96
                                                        prevention of         grams of pyrantel
                                                        migration and         tartrate per ton
                                                        establishment of      of complete feed
                                                        large roundworm       for 3 weeks or
                                                        (Ascaris suum)        until clinical
                                                        infections; and as    signs of the
                                                        an aid in the         disease disappear,
                                                        prevention of         following with 40
                                                        establishment of      grams of
                                                        nodular worm          lincomycin and 96
                                                        (Oesophagostomum      grams of pyrantel
                                                        spp.) infections.     tartrate per ton
                                                                              of complete feed
                                                                              as the sole
                                                                              ration. Not to be
                                                                              fed to swine that
                                                                              weigh more than
                                                                              250 pounds.
                                                                              Withdraw 6 days
                                                                              prior to
                                                                              slaughter.
                                                                              Lincomycin as
                                                                              provided by No.
                                                                              054771; pyrantel
                                                                              as provided by No.
                                                                              066104 in Sec.
                                                                              510.600(c) of this
                                                                              chapter.
(vi) 40.........................  Pyrantel, 800......  For the treatment     Feed as a single             066104
                                                        and/or control of     therapeutic
                                                        swine dysentery;      treatment at a
                                                        for removal and       rate of 1 lb of
                                                        control of large      feed per 40 lb of
                                                        roundworm (Ascaris    body weight for
                                                        suum) and nodular     animals up to 200
                                                        worm                  lb and 5 lb of
                                                        (Oesophagostomum      feed per head for
                                                        spp.) infections.     animals over 200
                                                                              lb. Not to be fed
                                                                              to swine that
                                                                              weigh more than
                                                                              250 pounds.
                                                                              Withdraw 24 hours
                                                                              prior to
                                                                              slaughter. See
                                                                              paragraph (d) of
                                                                              this section.
                                                                              Lincomycin as
                                                                              provided by No.
                                                                              054771; pyrantel
                                                                              as provided by No.
                                                                              066104 in Sec.
                                                                              510.600(c) of this
                                                                              chapter.

[[Page 475]]

 
(vii) 100.......................  ...................  For treatment of      Feed as the sole             054771
                                                        swine dysentery and   ration for 3 weeks
                                                        the control of        or until clinical
                                                        porcine               signs of the
                                                        proliferative         disease disappear.
                                                        enteropathies
                                                        (ileitis) caused by
                                                        Lawsonia
                                                        intracellularis.
(viii) 100......................  Fenbendazole, 10 to  For the treatment of  Feed as sole ration          000061
                                   80.                  swine dysentery;      to provide a total
                                                        and for the removal   dose of 9 mg
                                                        of: Adult stage       fenbendazole/kg of
                                                        lungworms             body weight within
                                                        (Metastrongylus       3 to 12 days. Do
                                                        apri and M.           not feed to swine
                                                        pudendotectus);       that weigh more
                                                        adult and larvae      than 250 pounds.
                                                        (L3, 4 stages--       Do not use within
                                                        liver, lung,          6 days of
                                                        intestinal forms)     slaughter.
                                                        large roundworms      Lincomycin as
                                                        (Ascaris suum);       provided by No.
                                                        adult stage nodular   054771;
                                                        worms                 fenbendazole as
                                                        (Oesophagostomum      provided by No.
                                                        dentatum, O.          000061 in Sec.
                                                        quadrispinulatum);    510.600(c) of this
                                                        adult stage small     chapter.
                                                        stomach worms
                                                        (Hyostrongylus
                                                        rubidus); adult and
                                                        larvae (L2, 3, 4
                                                        stages--intestinal
                                                        mucosal forms)
                                                        whipworms
                                                        (Trichuris suis);
                                                        adult and larvae
                                                        kidney worms
                                                        (Stephanurus
                                                        dentatus).
(ix) 100........................  Pyrantel, 96.......  For the treatment of  Feed as the sole             066104
                                                        swine dysentery; as   ration for 3 weeks
                                                        an aid in the         or until clinical
                                                        prevention of         signs of the
                                                        migration and         disease disappear.
                                                        establishment of      Not to be fed to
                                                        large roundworm       swine that weigh
                                                        (Ascaris suum)        more than 250
                                                        infections; and as    pounds. Withdraw 6
                                                        an aid in the         days prior to
                                                        prevention of         slaughter.
                                                        establishment of      Lincomycin as
                                                        nodular worm          provided by No.
                                                        (Oesophagostomum      054771; pyrantel
                                                        spp.) infections.     as provided by No.
                                                                              066104 in Sec.
                                                                              510.600(c) of this
                                                                              chapter.
(x) 100.........................  Pyrantel, 96.......  For the treatment     Feed for 3 days as           066104
                                                        and/or control of     the sole ration.
                                                        swine dysentery;      Not to be fed to
                                                        for removal and       swine that weigh
                                                        control of large      more than 250
                                                        roundworm (Ascaris    pounds. Withdraw
                                                        suum) infections.     24 hours prior to
                                                                              slaughter.
                                                                              Lincomycin as
                                                                              provided by No.
                                                                              054771; pyrantel
                                                                              as provided by No.
                                                                              066104 in Sec.
                                                                              510.600(c) of this
                                                                              chapter.
(xi) 100........................  Pyrantel, 800......  For the treatment     Feed as a single             066104
                                                        and/or control of     therapeutic
                                                        swine dysentery;      treatment. Not to
                                                        for removal and       be fed to swine
                                                        control of large      that weigh more
                                                        roundworm (Ascaris    than 250 pounds.
                                                        suum) and nodular     Withdraw 24 hours
                                                        worm                  prior to
                                                        (Oesophagostomum      slaughter.
                                                        spp.) infections.     Lincomycin as
                                                                              provided by No.
                                                                              054771; pyrantel
                                                                              as provided by No.
                                                                              066104 in Sec.
                                                                              510.600(c) of this
                                                                              chapter.
(xii) 100 to 200................  ...................  For reduction in the  Feed as sole ration          054771
                                                        severity of the       for 21 days.
                                                        effects of
                                                        respiratory disease
                                                        associated with
                                                        Mycoplasma
                                                        hyopneumoniae.

[[Page 476]]

 
(xiii) 200......................  Fenbendazole, 10 to  For reduction in the  Feed as sole ration          000061
                                   80.                  severity of swine     to provide a total
                                                        mycoplasmal           dose of 9 mg
                                                        pneumonia caused by   fenbendazole/kg of
                                                        Mycoplasma            body weight within
                                                        hyopneumoniae; and    3 to 12 days. Do
                                                        for the removal of:   not feed to swine
                                                        Adult stage           that weigh more
                                                        lungworms             than 250 pounds.
                                                        (Metastrongylus       Do not use within
                                                        apri and M.           6 days of
                                                        pudendotectus);       slaughter.
                                                        adult and larvae      Lincomycin as
                                                        (L3, 4 stages--       provided by No.
                                                        liver, lung,          054771;
                                                        intestinal forms)     fenbendazole as
                                                        large roundworms      provided by No.
                                                        (Ascaris suum);       000061 in Sec.
                                                        adult stage nodular   510.600(c) of this
                                                        worms                 chapter.
                                                        (Oesophagostomum
                                                        dentatum, O.
                                                        quadrispinulatum);
                                                        adult stage small
                                                        stomach worms
                                                        (Hyostrongylus
                                                        rubidus); adult and
                                                        larvae (L2, 3, 4
                                                        stages--intestinal
                                                        mucosal forms)
                                                        whipworms
                                                        (Trichuris suis);
                                                        adult and larvae
                                                        kidney worms
                                                        (Stephanurus
                                                        dentatus).
(xiv) 200.......................  Pyrantel, 96.......  For reduction in the  Feed as the sole             054771
                                                        severity of swine     ration for 21
                                                        mycoplasmal           days. Not for use
                                                        pneumonia caused by   in swine that
                                                        Mycoplasma            weigh more than
                                                        hyopneumoniae; and    250 pounds.
                                                        as an aid in the      Withdraw 6 days
                                                        prevention of         before slaughter.
                                                        migration and         Lincomycin as
                                                        establishment of      provided by No.
                                                        large roundworm       054771; pyrantel
                                                        (Ascaris suum)        as provided by No.
                                                        infections; aid in    066104 in Sec.
                                                        the prevention of     510.600(c) of this
                                                        establishment of      chapter.
                                                        nodular worm
                                                        (Oesophagostomum
                                                        spp.) infections.
----------------------------------------------------------------------------------------------------------------


[81 FR 95005, Dec. 27, 2016, as amended at 82 FR 12170, Mar. 1, 2017; 82 
FR 21691, May 10, 2017; 83 FR 13637, Mar. 30, 2018; 83 FR 14588, Apr. 5, 
2018; 83 FR 48947, Sept. 28, 2018; 83 FR 64741, Dec. 18, 2018; 84 FR 
8976, Mar. 13, 2019; 84 FR 12501, Apr. 2, 2019; 84 FR 39185, Aug. 9, 
2019; 86 FR 14824, Mar. 19, 2021]



Sec. 558.330  Lubabegron.

    (a) Specifications. Each pound of Type A medicated article contains 
4.54 grams (10 grams per kilogram) of lubabegron as lubabegron fumarate.
    (b) Sponsor. See No. 058198 in Sec. 510.600(c) of this chapter.
    (c) Related tolerances. See Sec. 556.370 of this chapter.
    (d) Conditions of use. (1) It is used in cattle feed as follows:

----------------------------------------------------------------------------------------------------------------
                                      Combination in
 Lubabegron fumarate in grams/ton       grams/ton        Indications for use        Limitations        Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 1.25 to 4.54.................  ...................  Beef steers and        Feed continuously as       058198
                                                         heifers fed in         the sole ration to
                                                         confinement for        provide 13 to 90 mg
                                                         slaughter: For         lubabegron/head/day
                                                         reduction of ammonia   during the last 14
                                                         gas emissions per      to 91 days on feed.
                                                         pound of live weight   A decrease in dry
                                                         and hot carcass        matter intake may
                                                         weight during the      be noticed in some
                                                         last 14 to 91 days     animals receiving
                                                         on feed.               lubabegron. Not
                                                                                approved for use in
                                                                                breeding animals
                                                                                because safety and
                                                                                effectiveness have
                                                                                not been evaluated
                                                                                in these animals.
                                                                                Do not allow horses
                                                                                or other equines
                                                                                access to feed
                                                                                containing
                                                                                lubabegron.

[[Page 477]]

 
(ii) 1.25 to 4.54................  Monensin, 5 to 40..  Beef steers and        Feed continuously as       058198
                                                         heifers fed in         the sole ration to
                                                         confinement for        provide 13 to 90 mg
                                                         slaughter: For         lubabegron/head/day
                                                         reduction of ammonia   and 50 to 480 mg
                                                         gas emissions per      monensin/head/day
                                                         pound of live weight   during the last 14
                                                         and hot carcass        to 91 days on feed.
                                                         weight and for         No additional
                                                         improved feed          improvement in feed
                                                         efficiency during      efficiency has been
                                                         the last 14 to 91      shown from feeding
                                                         days on feed.          monensin at levels
                                                                                greater than 30 g/
                                                                                ton (360 mg
                                                                                monensin/head/day.
                                                                                A decrease in dry
                                                                                matter intake may
                                                                                be noticed in some
                                                                                animals receiving
                                                                                lubabegron.
                                                                                Lubabegron has not
                                                                                been approved for
                                                                                use in breeding
                                                                                animals because
                                                                                safety and
                                                                                effectiveness have
                                                                                not been evaluated
                                                                                in these animals.
                                                                                Do not allow horses
                                                                                or other equines
                                                                                access to feed
                                                                                containing
                                                                                lubabegron and
                                                                                monensin. Ingestion
                                                                                of monensin by
                                                                                horses has been
                                                                                fatal. Monensin
                                                                                medicated cattle
                                                                                and goat feeds are
                                                                                safe for use in
                                                                                cattle and goats
                                                                                only. Consumption
                                                                                by unapproved
                                                                                species may result
                                                                                in toxic reactions.
                                                                                Feeding undiluted
                                                                                or mixing errors
                                                                                resulting in high
                                                                                concentrations of
                                                                                monensin has been
                                                                                fatal to cattle and
                                                                                could be fatal to
                                                                                goats. Must be
                                                                                thoroughly mixed in
                                                                                feeds before use.
                                                                                Do not exceed the
                                                                                levels of monensin
                                                                                recommended in the
                                                                                feeding directions,
                                                                                as reduced average
                                                                                daily gains may
                                                                                result. If feed
                                                                                refusals containing
                                                                                monensin are fed to
                                                                                other groups of
                                                                                cattle, the
                                                                                concentration of
                                                                                monensin in the
                                                                                refusals and amount
                                                                                of refusals fed
                                                                                should be taken
                                                                                into consideration
                                                                                to prevent monensin
                                                                                overdosing. A
                                                                                withdrawal period
                                                                                has not been
                                                                                established for
                                                                                this product for
                                                                                preruminating
                                                                                calves. Do not use
                                                                                in calves to be
                                                                                processed for veal.

[[Page 478]]

 
(iii) 1.25 to 4.54...............  Monensin, 10 to 40.  Beef steers and        Feed continuously as       058198
                                                         heifers fed in         the sole ration to
                                                         confinement for        provide 13 to 90 mg
                                                         slaughter: For         lubabegron/head/day
                                                         reduction of ammonia   and 0.14 to 0.42 mg
                                                         gas emissions per      monensin/lb body
                                                         pound of live weight   weight per day,
                                                         and hot carcass        depending upon
                                                         weight; and for        severity of
                                                         prevention and         coccidiosis
                                                         control of             challenge, during
                                                         coccidiosis due to     the last 14 to 91
                                                         Eimeria bovis and E.   days on feed. A
                                                         zuernii during the     decrease in dry
                                                         last 14 to 91 days     matter intake may
                                                         on feed.               be noticed in some
                                                                                animals receiving
                                                                                lubabegron.
                                                                                Lubabegron has not
                                                                                been approved for
                                                                                use in breeding
                                                                                animals because
                                                                                safety and
                                                                                effectiveness have
                                                                                not been evaluated
                                                                                in these animals.
                                                                                Do not allow horses
                                                                                or other equines
                                                                                access to feed
                                                                                containing
                                                                                lubabegron and
                                                                                monensin. Ingestion
                                                                                of monensin by
                                                                                horses has been
                                                                                fatal. Monensin
                                                                                medicated cattle
                                                                                and goat feeds are
                                                                                safe for use in
                                                                                cattle and goats
                                                                                only. Consumption
                                                                                by unapproved
                                                                                species may result
                                                                                in toxic reactions.
                                                                                Feeding undiluted
                                                                                or mixing errors
                                                                                resulting in high
                                                                                concentrations of
                                                                                monensin has been
                                                                                fatal to cattle and
                                                                                could be fatal to
                                                                                goats. Must be
                                                                                thoroughly mixed in
                                                                                feeds before use.
                                                                                Do not exceed the
                                                                                levels of monensin
                                                                                recommended in the
                                                                                feeding directions,
                                                                                as reduced average
                                                                                daily gains may
                                                                                result. If feed
                                                                                refusals containing
                                                                                monensin are fed to
                                                                                other groups of
                                                                                cattle, the
                                                                                concentration of
                                                                                monensin in the
                                                                                refusals and amount
                                                                                of refusals fed
                                                                                should be taken
                                                                                into consideration
                                                                                to prevent monensin
                                                                                overdosing. A
                                                                                withdrawal period
                                                                                has not been
                                                                                established for
                                                                                this product for
                                                                                preruminating
                                                                                calves. Do not use
                                                                                in calves to be
                                                                                processed for veal.
----------------------------------------------------------------------------------------------------------------

    (2) Lubabegron may also be used in combination with:
    (i) Tylosin as in Sec. 558.625.
    (ii) [Reserved]

[84 FR 12501, Apr. 2, 2019, as amended at 84 FR 53311, Oct. 7, 2019]



Sec. 558.340  Maduramicin.

    (a) Specifications. Type A medicated articles containing 4.54 grams 
maduramicin per pound.
    (b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
    (c) Tolerances. See Sec. 556.375 of this chapter.
    (d) Conditions of use in chickens--

[[Page 479]]



----------------------------------------------------------------------------------------------------------------
        Amount in grams/ton                Indications for use                  Limitations             Sponsor
----------------------------------------------------------------------------------------------------------------
(1) 4.54 to 5.45...................  Broiler chickens: For            Feed continuously as sole           054771
                                      prevention of coccidiosis        ration. For broiler chickens
                                      caused by Eimeria acervulina,    only. Do not feed to laying
                                      E. tenella, E. brunetti, E.      hens. Withdraw 5 days before
                                      maxima, E. necatrix, and E.      slaughter.
                                      mivati.
(2) [Reserved]
----------------------------------------------------------------------------------------------------------------


[85 FR 45310, July 28, 2020]



Sec. 558.342  Melengestrol.

    (a) Specifications. (1) Dry Type A medicated articles containing 100 
or 200 milligrams (mg) melengestrol acetate per pound.
    (2) Liquid Type A medicated article containing 500 mg melengestrol 
acetate per pound.
    (b) Sponsor. See sponsors in Sec. 510.600(c) of this chapter for 
use as in paragraph (e) of this section.
    (c) Related tolerances. See Sec. 556.380 of this chapter.
    (d) Special considerations. (1) Type B or C medicated feeds may be 
manufactured from melengestrol acetate liquid Type A articles or Type B 
or C medicated feeds which have a pH of 4.0 to 8.0 and bear appropriate 
mixing directions as follows:
    (i) For liquid feeds stored in recirculating tank systems: 
Recirculate immediately prior to use for no less than 10 minutes, moving 
not less than 1 percent of the tank contents per minute from the bottom 
of the tank to the top. Recirculate daily as described even when not 
used.
    (ii) For liquid feeds stored in mechanical, air, or other agitation 
type tank systems: Agitate immediately prior to use for not less than 10 
minutes, creating a turbulence at the bottom of the tank that is visible 
at the top. Agitate daily as described even when not used.
    (2) A physically stable melengestrol acetate liquid Type B or C feed 
will not be subject to the requirements for mixing directions prescribed 
in paragraph (d)(1) of this section provided it has a pH of 4.0 to 8.0 
and contains a suspending agent(s) sufficient to maintain a viscosity of 
not less than 300 centipoises per second for 3 months.
    (3) Liquid or dry combination Type B or C medicated feeds containing 
melengestrol acetate and lasalocid must be labeled in accordance with 
Sec. 558.311(d).
    (4) Liquid or dry combination Type B or C medicated feeds containing 
melengestrol acetate and monensin must be labeled in accordance with 
Sec. 558.355(d).
    (5) Liquid combination Type B or C medicated feeds containing 
melengestrol acetate and tylosin must be manufactured in accordance with 
Sec. 558.625(d).
    (6) Liquid melengestrol acetate may not be mixed with 
oxytetracycline in a common liquid feed supplement.
    (e) Conditions of use--(1) Cattle.

----------------------------------------------------------------------------------------------------------------
Melengestrol  acetate in  mg/head/    Combination  in
               day                       grams/ton         Indications for use        Limitations       Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 0.25 to 0.5..................  ....................  Heifers fed in           Administer 0.5 to       016592
                                                          confinement for          2.0 pounds (lb)/       054771
                                                          slaughter: For           head/day of            058198
                                                          increased rate of        medicated feed
                                                          weight gain, improved    containing 0.125
                                                          feed efficiency, and     to 1.0 mg
                                                          suppression of estrus    melengestrol
                                                          (heat)..                 acetate/lb to
                                                                                   provide 0.25 to
                                                                                   0.5 mg
                                                                                   melengestrol
                                                                                   acetate/head/day..
(ii) 0.5.........................  ....................  Heifers intended for     Administer 0.5 to      054771,
                                                          breeding: For            2.0 lb/head/day of     058198
                                                          suppression of estrus    Type C feed
                                                          (heat)..                 containing 0.25 to
                                                                                   1.0 mg
                                                                                   melengestrol
                                                                                   acetate/lb to
                                                                                   provide 0.5 mg
                                                                                   melengestrol
                                                                                   acetate/head/day.
                                                                                   Do not exceed 24
                                                                                   days of feeding..

[[Page 480]]

 
(iii) 0.25 to 0.5................  Lasalocid, 10 to 30.  Heifers fed in           Add at the rate of     054771,
                                                          confinement for          0.5 to 2.0 lb/head/    058198
                                                          slaughter: For           day a medicated
                                                          increased rate of        feed (liquid or
                                                          weight gain, improved    dry) containing
                                                          feed efficiency, and     0.125 to 1.0 mg
                                                          suppression of estrus    melengestrol
                                                          (heat); and for          acetate/lb to a
                                                          control of coccidiosis   feed containing 10
                                                          caused by Eimeria        to 30 g of
                                                          bovis and Eimeria        lasalocid per ton
                                                          zuernii.                 to provide 0.25 to
                                                                                   0.5 mg
                                                                                   melengestrol
                                                                                   acetate and 100 to
                                                                                   360 milligrams of
                                                                                   lasalocid per head/
                                                                                   day. See Sec.
                                                                                   558.311(d) of this
                                                                                   chapter. Lasalocid
                                                                                   as provided by No.
                                                                                   054771 in Sec.
                                                                                   510.600(c) of this
                                                                                   chapter.
(iv) 0.25 to 0.5.................  Monensin, 10 to 40..  Heifers fed in           Add at the rate of     016592,
                                                          confinement for          0.5 to 2 lb/head/     054771,
                                                          slaughter: For           day a medicated        058198
                                                          increased rate of        feed (liquid or
                                                          weight gain, improved    dry) containing
                                                          feed efficiency, and     0.125 to 1 mg
                                                          suppression of estrus    melengestrol
                                                          (heat); and for the      acetate/lb to a
                                                          prevention and control   feed containing 10
                                                          of coccidiosis due to    to 40 g of
                                                          Eimeria bovis and E.     monensin per ton
                                                          zuernii.                 to provide 0.25 to
                                                                                   0.5 mg
                                                                                   melengestrol
                                                                                   acetate/head/day
                                                                                   and 0.14 to 0.42
                                                                                   mg monensin/lb
                                                                                   body weight,
                                                                                   depending on
                                                                                   severity of
                                                                                   coccidiosis
                                                                                   challenge, up to
                                                                                   480 mg monensin/
                                                                                   head/day. See Sec.
                                                                                     558.355(d).
                                                                                   Monensin as
                                                                                   provided by No.
                                                                                   016592 or 058198
                                                                                   in Sec.
                                                                                   510.600(c) of this
                                                                                   chapter.
----------------------------------------------------------------------------------------------------------------

    (2) Melengestrol may also be used in combination with:
    (i) Oxytetracycline as in Sec. 558.450.
    (ii) Ractopamine as in Sec. 558.500.
    (iii) Tylosin as in Sec. 558.625.
    (iv) Zilpaterol as in Sec. 558.665.

[42 FR 28535, June 3, 1977]

    Editorial Note: For Federal Register citations affecting Sec. 
558.342, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and at www.govinfo.gov.



Sec. 558.348  Mibolerone.

    (a) Specifications. Each 6.5 ounce can contains 30 or 60 micrograms 
([micro]g) of mibolerone.
    (b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use in dogs--(1) Amount. 30 [micro]g for animals 
weighing up to 25 pounds; 60 [micro]g for animals weighing 26 to 50 
pounds; 120 [micro]g for animals weighing 51 to 100 pounds; 180 [micro]g 
for animals weighing over 100 pounds, or German Shepherds or German 
Shepherd mix weighing 30 to 80 pounds. Administer daily at least 30 days 
before expected initiation of heat and continue as long as desired, but 
for not more than 12 months.
    (2) Indications for use. For the prevention of estrus (heat) in 
adult female dogs not intended primarily for breeding purposes.
    (3) Limitations. Mibolerone should not be used in bitches before 
first estrous period or in purebred Bedlington terriers. It is not 
intended for animals being used primarily for breeding purposes. Use 
orally in adult female dogs only. Federal law restricts this drug to use 
by or on the order of a licensed veterinarian.

[85 FR 45310, July 28, 2020]



Sec. 558.355  Monensin.

    (a) Specifications. Type A medicated articles containing 45, 60, 
90.7, or 110 grams monensin, USP, per pound.
    (b) Sponsors. See sponsors in Sec. 510.600(c) of this chapter as 
follows:
    (1) No. 058198 for use as in paragraph (f) of this section.
    (2) No. 016592 for use of a Type A medicated article containing 90.7 
grams monensin, USP, per pound as in

[[Page 481]]

paragraphs (f)(3), (f)(4)(vi), and (f)(6) of this section.
    (c) Related tolerances. See Sec. 556.420 of this chapter.
    (d) Special considerations. (1) Type C chicken feed containing 
monensin as the mycelial cake shall bear an expiration date of 90 days 
after its date of manufacture.
    (2)-(3) [Reserved]
    (4) Liquid Type B feeds shall bear an expiration date of 8 weeks 
after its date of manufacture.
    (5) All Type A medicated articles containing monensin shall bear the 
following warning statement: When mixing and handling monensin Type A 
medicated articles, use protective clothing, impervious gloves, and a 
dust mask. Operators should wash thoroughly with soap and water after 
handling. If accidental eye contact occurs, immediately rinse thoroughly 
with water.
    (6) All formulations containing monensin shall bear the following 
caution statement: Do not allow horses or other equines access to feed 
containing monensin. Ingestion of monensin by horses has been fatal.
    (7) Type A medicated articles containing monensin intended for use 
in cattle and goats shall bear, in addition to the caution statement in 
paragraph (d)(6) of this section, the following statements:
    (i) Monensin medicated cattle and goat feeds are safe for use in 
cattle and goats only. Consumption by unapproved species may result in 
toxic reactions.
    (ii) Feeding undiluted or mixing errors resulting in high 
concentrations of monensin has been fatal to cattle and could be fatal 
to goats.
    (iii) Must be thoroughly mixed in feeds before use.
    (iv) Do not feed undiluted.
    (v) Do not exceed the levels of monensin recommended in the feeding 
directions, as reduced average daily gains may result.
    (vi) Do not feed to lactating goats.
    (vii) If feed refusals containing monensin are fed to other groups 
of cattle, the concentration of monensin in the refusals and amount of 
refusals fed should be taken into consideration to prevent monensin 
overdosing (see paragraphs (d)(10)(i) and (d)(10)(ii) of this section).
    (viii) A withdrawal period has not been established for this product 
in pre-ruminating calves. Do not use in calves to be processed for veal.
    (ix) You may notice the following: Reduced voluntary feed intake in 
dairy cows fed monensin. This reduction increases with higher doses of 
monensin fed. Rule out monensin as the cause of reduced feed intake 
before attributing to other causes such as illness, feed management, or 
the environment. Reduced milk fat percentage in dairy cows fed monensin. 
This reduction increases with higher doses of monensin fed. Increased 
incidence of cystic ovaries and metritis in dairy cows fed monensin. 
Reduced conception rates, increased services per animal, and extended 
days open and corresponding calving intervals in dairy cows fed 
monensin. Have a comprehensive and ongoing nutritional, reproductive, 
and herd health program in place when feeding monensin to dairy cows.
    (x) Inadequate mixing (recirculation or agitation) of monensin 
liquid Type B or Type C medicated feeds has resulted in increased 
monensin concentration which has been fatal to cattle and could be fatal 
to goats.
    (8) Type A medicated articles containing monensin intended for use 
in chickens, turkeys, and quail shall bear the following statements:
    (i) Do not allow horses, other equines, mature turkeys, or guinea 
fowl access to feed containing monensin. Ingestion of monensin by horses 
and guinea fowl has been fatal.
    (ii) Must be thoroughly mixed in feeds before use.
    (iii) Do not feed undiluted.
    (iv) Do not feed to laying chickens.
    (v) Do not feed to chickens over 16 weeks of age.
    (vi) For replacement chickens intended for use as cage layers only.
    (vii) Some strains of turkey coccidia may be monensin tolerant or 
resistant. Monensin may interfere with development of immunity to turkey 
coccidiosis.
    (viii) In the absence of coccidiosis in broiler chickens the use of 
monensin with no withdrawal period may limit

[[Page 482]]

feed intake resulting in reduced weight gain.
    (9) Type B feeds containing monensin shall bear the statements 
specified in the following paragraphs of this section when intended for 
use in:
    (i) Cattle (as described in paragraphs (f)(3)(i) through (iii), 
(vi), and (vii) and (f)(4)(i) through (vi) of this section). See 
paragraphs (d)(6) and (d)(7)(i) through (v), (vii), and (viii) of this 
section.
    (ii) Dairy cows (as described in paragraphs (f)(3)(iv) and (v) of 
this section). See paragraphs (d)(6) and (d)(7)(i) through (iv), (vii), 
(viii), and (ix) of this section.
    (iii) Goats: See paragraphs (d)(6) and (d)(7)(i) through (d)(7)(vi) 
of this section.
    (iv) Chickens: See paragraphs (d)(8)(i) through (d)(8)(vi), and 
(d)(8)(viii) of this section.
    (v) Turkeys: See paragraphs (d)(8)(i), (d)(8)(ii), (d)(8)(iii), and 
(d)(8)(vii) of this section.
    (vi) Quail: See paragraphs (d)(8)(i), (d)(8)(ii), and (d)(8)(iii) of 
this section.
    (10) Type C feeds containing monensin shall bear the statements 
specified in the following paragraphs of this section when intended for 
use in:
    (i) Cattle (as described in paragraphs (f)(3)(i) through (iii), 
(vi), and (vii) and (f)(4)(i) through (vi) of this section). See 
paragraphs (d)(6) and (d)(7)(i), (v), (vii), and (viii) of this section. 
Paragraph (d)(7)(vii) of this section does not apply to free-choice Type 
C medicated feeds as defined in Sec. 510.455 of this chapter.
    (ii) Dairy cows (as described in paragraphs (f)(3)(iv) and (v) of 
this section). See paragraphs (d)(6) and (d)(7)(i), (vii), (viii), and 
(ix) of this section. Paragraph (d)(7)(vii) of this section does not 
apply to free-choice Type C medicated feeds as defined in Sec. 510.455 
of this chapter.
    (iii) Goats: See paragraphs (d)(6), (d)(7)(i), (d)(7)(v), and 
(d)(7)(vi) of this section.
    (iv) Chickens: See paragraphs (d)(8)(i), (d)(8)(iv), (d)(8)(v), 
(d)(8)(vi), and (d)(8)(viii) of this section.
    (v) Turkeys: See paragraphs (d)(8)(i) and (d)(8)(vii) of this 
section.
    (vi) Quail: See paragraph (d)(8)(i) of this section.
    (11) Type B and Type C liquid feeds requiring recirculation or 
agitation that contain monensin and are intended for use in cattle 
(including dairy cows) and goats shall bear the caution statement 
specified in paragraph (d)(7)(x) of this section.
    (12) Mixing directions for liquid feeds requiring recirculation or 
agitation:
    (i) For liquid feeds stored in recirculating tank systems: 
Recirculate immediately prior to use for not less than 10 minutes, 
moving not less than 1 percent of the tank contents per minute from the 
bottom of the tank to the top. Recirculate daily as described even when 
not used.
    (ii) For liquid feeds stored in mechanical, air, or other agitation-
type tank systems: Agitate immediately prior to use for not less than 10 
minutes, creating a turbulence at the bottom of the tank that is visible 
at the top. Agitate daily as described even when not used.
    (e) [Reserved]
    (f) Conditions of use. It is used as follows:
    (1) Chickens--

----------------------------------------------------------------------------------------------------------------
                                  Combination in
     Monensin in grams/ton          grams/ton        Indications for use        Limitations           Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 90 to 110.................  .................  Broiler chickens: As    Feed continuously as           058198
                                                    an aid in the           the sole ration. In
                                                    prevention of           the absence of
                                                    coccidiosis caused by   coccidiosis, the use
                                                    E. necatrix, E.         of monensin with no
                                                    tenella, E.             withdrawal period
                                                    acervulina, E.          may limit feed
                                                    brunetti, E. mivati,    intake resulting in
                                                    and E. maxima.          reduced weight gain.
                                                                            Do not feed to
                                                                            laying chickens.
(ii) 90 to 110................  .................  Replacement chickens    Feed continuously as           058198
                                                    intended for use as     the sole ration. Do
                                                    cage layers: As an      not feed to chickens
                                                    aid in the prevention   over 16 weeks of
                                                    of coccidiosis caused   age. Do not feed to
                                                    by E. necatrix, E.      laying chickens.
                                                    tenella, E.
                                                    acervulina, E.
                                                    brunetti, E. mivati,
                                                    and E. maxima.

[[Page 483]]

 
(iii) 90 to 110...............  Bacitracin         Broiler chickens: As    Feed continuously as           054771
                                 methylenedisalic   an aid in the           sole ration. In the
                                 ylate, 4 to 50.    prevention of           absence of
                                                    coccidiosis caused by   coccidiosis, the use
                                                    E. necatrix, E.         of monensin with no
                                                    tenella, E.             withdrawal period
                                                    acervulina, E.          may limit feed
                                                    brunetti, E. mivati,    intake resulting in
                                                    and E. maxima, and      reduced weight gain.
                                                    for improved feed       Do not feed to
                                                    efficiency.             laying chickens.
                                                                            Bacitracin
                                                                            methylenedisalicylat
                                                                            e provided by No.
                                                                            054771 in Sec.
                                                                            510.600(c) of this
                                                                            chapter.
(iv) 90 to 110................  Bacitracin         Replacement chickens    Feed continuously as           054771
                                 methylenedisalic   intended for use as     sole ration. Do not
                                 ylate, 4 to 50.    cage layers: As an      feed to chickens
                                                    aid in the prevention   over 16 weeks of
                                                    of coccidiosis caused   age. Do not feed to
                                                    by E. necatrix, E.      laying chickens.
                                                    tenella, E.             Monensin sodium
                                                    acervulina, E.          provided by No.
                                                    brunetti, E. mivati,    058198, bacitracin
                                                    and E. maxima, and      methylenedisalicylat
                                                    for increased rate of   e provided by No.
                                                    weight gain and         054771 in Sec.
                                                    improved feed           510.600(c) of this
                                                    efficiency.             chapter.
(v) 90 to 110.................  Bacitracin         Broiler chickens: As    Feed continuously as           058198
                                 methylenedisalic   an aid in the           sole ration. In the
                                 ylate, 5 to 25.    prevention of           absence of
                                                    coccidiosis caused by   coccidiosis, the use
                                                    E. necatrix, E.         of monensin with no
                                                    tenella, E.             withdrawal period
                                                    acervulina, E.          may limit feed
                                                    brunetti, E. mivati,    intake resulting in
                                                    and E. maxima, and      reduced weight gain.
                                                    for increased rate of   Do not feed to
                                                    weight gain and         laying chickens.
                                                    improved feed           Bacitracin
                                                    efficiency.             methylenedisalicylat
                                                                            e provided by No.
                                                                            054771 in Sec.
                                                                            510.600(c) of this
                                                                            chapter.
(vi) 90 to 110................  Bacitracin         Broiler and             Feed continuously as           054771
                                 methylenedisalic   replacement chickens    sole ration. Do not
                                 ylate, 50.         intended for use as     feed to chickens
                                                    cage layers: As an      over 16 weeks of
                                                    aid in the prevention   age. Do not feed to
                                                    of coccidiosis caused   laying chickens.
                                                    by E. necatrix, E.      Monensin sodium
                                                    tenella, E.             provided by No.
                                                    acervulina, E.          058198, bacitracin
                                                    brunetti, E. mivati,    methylenedisalicylat
                                                    and E. maxima, and      e provided by No.
                                                    for improved feed       054771 in Sec.
                                                    efficiency, and as an   510.600(c) of this
                                                    aid in the prevention   chapter.
                                                    of necrotic enteritis
                                                    caused or complicated
                                                    by Clostridium spp.
                                                    or other organisms
                                                    susceptible to
                                                    bacitracin.
(vii) 90 to 110...............  Bacitracin zinc,   Broiler chickens: As    Feed continuously as           054771
                                 4 to 50.           an aid in the           sole ration. In the
                                                    prevention of           absence of
                                                    coccidiosis caused by   coccidiosis, the use
                                                    E. necatrix, E.         of monensin with no
                                                    tenella, E.             withdrawal period
                                                    acervulina, E.          may limit feed
                                                    brunetti, E. mivati,    intake resulting in
                                                    and E. maxima, and      reduced weight gain.
                                                    for increased rate of   Do not feed to
                                                    weight gain and         laying chickens.
                                                    improved feed           Bacitracin zinc
                                                    efficiency.             provided by No.
                                                                            054771 in Sec.
                                                                            510.600(c) of this
                                                                            chapter.
(viii) 90 to 110..............  Bacitracin zinc,   Broiler chickens: As    Feed continuously as           058198
                                 10.                an aid in the           sole ration. In the
                                                    prevention of           absence of
                                                    coccidiosis caused by   coccidiosis, the use
                                                    E. necatrix, E.         of monensin with no
                                                    tenella, E.             withdrawal period
                                                    acervulina, E.          may limit feed
                                                    brunetti, E. mivati,    intake resulting in
                                                    and E. maxima, and      reduced weight gain.
                                                    for increased rate of   Do not feed to
                                                    weight gain and         laying chickens.
                                                    improved feed           Bacitracin zinc
                                                    efficiency.             provided by No.
                                                                            054771 in Sec.
                                                                            510.600(c) of this
                                                                            chapter.
(ix) 90 to 110................  Bacitracin zinc,   Broiler chickens: As    Feed continuously as           058198
                                 10 to 30.          an aid in the           sole ration. In the
                                                    prevention of           absence of
                                                    coccidiosis caused by   coccidiosis, the use
                                                    E. necatrix, E.         of monensin with no
                                                    tenella, E.             withdrawal period
                                                    acervulina, E.          may limit feed
                                                    brunetti, E. mivati,    intake resulting in
                                                    and E. maxima, and      reduced weight gain.
                                                    for improved feed       Do not feed to
                                                    efficiency.             laying chickens.
                                                                            Bacitracin zinc
                                                                            provided by No.
                                                                            054771 in Sec.
                                                                            510.600(c) of this
                                                                            chapter.
(x) 90 to 110.................  Bambermycins, 1    Broiler chickens: As    Feed continuously as   016592, 058198
                                 to 2.              an aid in the           sole ration. Do not
                                                    prevention of           feed to laying
                                                    coccidiosis caused by   chickens.
                                                    E. necatrix, E.         Bambermycins
                                                    tenella, E.             provided by No.
                                                    acervulina, E.          016592 in Sec.
                                                    brunetti, E. mivati,    510.600(c) of this
                                                    and E. maxima, and      chapter.
                                                    for increased rate of
                                                    weight gain and
                                                    improved feed
                                                    efficiency.
----------------------------------------------------------------------------------------------------------------


[[Page 484]]

    (2) Turkeys--

----------------------------------------------------------------------------------------------------------------
                                  Combination in
     Monensin in grams/ton          grams/ton        Indications for use        Limitations           Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 54 to 90..................  .................  Growing turkeys: For    For growing turkeys            058198
                                                    the prevention of       only. Feed
                                                    coccidiosis caused by   continuously as sole
                                                    E. adenoeides, E.       ration. Some strains
                                                    meleagrimitis, and E.   of turkey coccidia
                                                    gallopavonis.           may be monensin
                                                                            tolerant or
                                                                            resistant. Monensin
                                                                            may interfere with
                                                                            development of
                                                                            immunity to turkey
                                                                            coccidiosis. Do not
                                                                            allow horses, other
                                                                            equines, mature
                                                                            turkeys, or guinea
                                                                            fowl access to feed
                                                                            containing monensin.
                                                                            Ingestion of
                                                                            monensin by horses
                                                                            and guinea fowl has
                                                                            been fatal.
(ii) 54 to 90.................  Bacitracin         Growing turkeys: For    For growing turkeys            058198
                                 methylenedisalic   the prevention of       only. Feed
                                 ylate, 4 to 50.    coccidiosis caused by   continuously as sole
                                                    E. adenoeides, E.       ration. Some strains
                                                    meleagrimitis, and E.   of turkey coccidia
                                                    gallopavonis, and for   may be monensin
                                                    increased rate of       tolerant or
                                                    weight gain and         resistant. Monensin
                                                    improved feed           may interfere with
                                                    efficiency.             development of
                                                                            immunity to turkey
                                                                            coccidiosis. Do not
                                                                            allow horses, other
                                                                            equines, mature
                                                                            turkeys, or guinea
                                                                            fowl access to feed
                                                                            containing monensin.
                                                                            Ingestion of
                                                                            monensin by horses
                                                                            and guinea fowl has
                                                                            been fatal.
                                                                            Bacitracin
                                                                            methylenedisalicylat
                                                                            e as provided by No.
                                                                            054771 in Sec.
                                                                            510.600(c) of this
                                                                            chapter.
(iii) 54 to 90................  Bacitracin         Growing turkeys: For    For growing turkeys            058198
                                 methylenedisalic   the prevention of       only. Feed
                                 ylate, 200.        coccidiosis caused by   continuously as sole
                                                    E. adenoeides, E.       ration. Some strains
                                                    meleagrimitis, and E.   of turkey coccidia
                                                    gallopavonis, and as    may be monensin
                                                    an aid in the control   tolerant or
                                                    of transmissible        resistant. Monensin
                                                    enteritis complicated   may interfere with
                                                    by organisms            development of
                                                    susceptible to          immunity to turkey
                                                    bacitracin              coccidiosis. Do not
                                                    methylenedisalicylate.  allow horses, other
                                                                            equines, mature
                                                                            turkeys, or guinea
                                                                            fowl access to feed
                                                                            containing monensin.
                                                                            Ingestion of
                                                                            monensin by horses
                                                                            and guinea fowl has
                                                                            been fatal.
                                                                            Bacitracin
                                                                            methylenedisalicylat
                                                                            e as provided by No.
                                                                            054771 in Sec.
                                                                            510.600(c) of this
                                                                            chapter.
(iv) 54 to 90.................  Bambermycins, 1    Growing turkeys: For    For growing turkeys            058198
                                 to 2.              the prevention of       only. Feed
                                                    coccidiosis in          continuously as sole
                                                    turkeys caused by E.    ration. Some strains
                                                    adenoeides, E.          of turkey coccidia
                                                    meleagrimitis, and E.   may be monensin
                                                    gallopavonis, and for   tolerant or
                                                    improved feed           resistant. Monensin
                                                    efficiency.             may interfere with
                                                                            development of
                                                                            immunity to turkey
                                                                            coccidiosis.
                                                                            Bambermycins as
                                                                            provided by No.
                                                                            016592 in Sec.
                                                                            510.600(c) of this
                                                                            chapter.
(v) 54 to 90..................  Bambermycins, 2..  Growing turkeys: For    For growing turkeys            058198
                                                    the prevention of       only. Feed
                                                    coccidiosis caused by   continuously as sole
                                                    E. adenoeides, E.       ration. Some strains
                                                    meleagrimitis, and E.   of turkey coccidia
                                                    gallopavonis, and for   may be monensin
                                                    increased rate of       tolerant or
                                                    weight gain and         resistant. Monensin
                                                    improved feed           may interfere with
                                                    efficiency.             development of
                                                                            immunity to turkey
                                                                            coccidiosis.
                                                                            Bambermycins as
                                                                            provided by No.
                                                                            016592 in Sec.
                                                                            510.600(c) of this
                                                                            chapter.
----------------------------------------------------------------------------------------------------------------

    (3) Cattle--

[[Page 485]]



----------------------------------------------------------------------------------------------------------------
        Monensin in grams/ton              Indications for use               Limitations              Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 5 to 40.........................  Cattle fed in confinement     Feed continuously in                  058198
                                       for slaughter: For improved   complete feed at a rate of
                                       feed efficiency.              50 to 480 milligrams of
                                                                     monensin per head per day.
                                                                     No additional improvement
                                                                     in feed efficiency has been
                                                                     shown from feeding monensin
                                                                     at levels greater than 30
                                                                     grams per ton (360
                                                                     milligrams per head per
                                                                     day).
(ii) 10 to 40.......................  Cattle fed in confinement     Feed at a rate of 0.14 to             058198
                                       for slaughter: For            0.42 milligram per pound of
                                       prevention and control of     body weight per day,
                                       coccidiosis due to E. bovis   depending upon the severity
                                       and E. zuernii.               of challenge, up to maximum
                                                                     of 480 milligrams per head
                                                                     per day.
(iii) 10 to 200.....................  Calves excluding veal         Feed at a rate of 0.14 to             058198
                                       calves: For prevention and    1.0 milligram monensin per
                                       control of coccidiosis due    pound of body weight per
                                       to E. bovis and E. zuernii.   day, depending upon the
                                                                     severity of challenge, up
                                                                     to maximum of 200
                                                                     milligrams per head per day.
(iv) 11 to 22.......................  Dairy cows: For increased     Feed continuously to dry and          058198
                                       milk production efficiency    lactating dairy cows in a
                                       (production of marketable     total mixed ration
                                       solids-corrected milk per     (``complete feed''). See
                                       unit of feed intake).         special labeling
                                                                     considerations in paragraph
                                                                     (d) of this section.
(v) 11 to 400.......................  Dairy cows: For increased     Feed continuously to dry and          058198
                                       milk production efficiency    lactating dairy cows in a
                                       (production of marketable     component feeding system
                                       solids-corrected milk per     (including top dress). The
                                       unit of feed intake).         Type C medicated feed must
                                                                     be fed in a minimum of 1 lb
                                                                     of feed to provide 185 to
                                                                     660 mg/head/day monensin to
                                                                     lactating cows or 115 to
                                                                     410 mg/head/day monensin to
                                                                     dry cows. See special
                                                                     labeling considerations in
                                                                     paragraph (d) of this
                                                                     section.
(vi) 15 to 400......................  Growing cattle on pasture or  For increased rate of weight          058198
                                       in dry lot (stocker and       gain, feed at a rate of 50
                                       feeder cattle and dairy and   to 200 milligrams monensin
                                       beef replacement heifers):    per head per day in not
                                       For increased rate of         less than 1 pound of feed
                                       weight gain, and for          or, after the 5th day, feed
                                       prevention and control of     at a rate of 400 milligrams
                                       coccidiosis due to E. bovis   per head per day every
                                       and E. zuernii.               other day in not less than
                                                                     2 pounds of feed. For
                                                                     prevention and control of
                                                                     coccidiosis, feed at a rate
                                                                     of 0.14 to 0.42 milligram
                                                                     per pound of body weight
                                                                     per day, depending on
                                                                     severity of challenge, up
                                                                     to 200 milligrams per head
                                                                     per day. During first 5
                                                                     days of feeding, cattle
                                                                     should receive no more than
                                                                     100 milligrams per day in
                                                                     not less than 1 pound of
                                                                     feed.
(vii) 25 to 400.....................  For improved feed             Feed to mature reproducing            058198
                                       efficiency, and for           beef cows. Feed as
                                       prevention and control of     supplemental feed, either
                                       coccidiosis due to E. bovis   hand-fed in a minimum of 1
                                       and E. zuernii.               pound of feed or mixed in a
                                                                     total ration. For improved
                                                                     feed efficiency, feed
                                                                     continuously at a rate of
                                                                     50 to 200 milligrams
                                                                     monensin per head per day.
                                                                     For prevention and control
                                                                     of coccidiosis, feed at a
                                                                     rate of 0.14 to 0.42
                                                                     milligram per pound of body
                                                                     weight per day, depending
                                                                     upon severity of challenge,
                                                                     up to a maximum of 200
                                                                     milligrams per head per
                                                                     day. During first 5 days of
                                                                     feeding, cattle should
                                                                     receive no more than 100
                                                                     milligrams per head per day.
----------------------------------------------------------------------------------------------------------------

    (4) Free-choice cattle feeds--

[[Page 486]]



----------------------------------------------------------------------------------------------------------------
           Monensin amount                 Indications for use               Limitations              Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 150 milligrams per pound of       Pasture cattle (slaughter,    Provide 50 to 200 milligrams          058198
 protein-mineral block (0.033%).       stocker, feeder, and dairy    of monensin (0.34 to 1.33
                                       and beef replacement          pounds of block) per head
                                       heifers): For increased       per day, at least 1 block
                                       rate of weight gain, and      per 10 to 12 head of
                                       for prevention and control    cattle. Roughage must be
                                       of coccidiosis caused by E.   available at all times. Do
                                       bovis and E. zuernii in       not allow animals access to
                                       pasture cattle which may      other protein blocks, salt
                                       require supplemental feed.    or mineral, while being fed
                                                                     this product. The
                                                                     effectiveness of this block
                                                                     in cull cows and bulls has
                                                                     not been established. See
                                                                     paragraph (d)(10)(i) of
                                                                     this section.
(ii) 175 milligrams per pound of      Pasture cattle (slaughter,    Provide 40 to 200 milligrams          017800
 protein-mineral block (0.038%).       stocker, and feeder): For     of monensin (0.25 to 1.13
                                       increased rate of weight      pounds or 4 to 18 ounces of
                                       gain.                         block) per head per day, at
                                                                     least 1 block per 4 head of
                                                                     cattle. Do not allow cattle
                                                                     access to salt or mineral
                                                                     while being fed this
                                                                     product. Ingestion by
                                                                     cattle of monensin at
                                                                     levels of 600 milligrams
                                                                     per head per day and higher
                                                                     has been fatal. The
                                                                     effectiveness of this block
                                                                     in cull cows and bulls has
                                                                     not been established. See
                                                                     paragraph (d)(10)(i) of
                                                                     this section.
(iii) 400 milligrams per pound of     Pasture cattle (slaughter,    Provide 80 to 200 milligrams          067949
 protein-mineral block (0.088%).       stocker, feeder, and dairy    of monensin (0.2 to 0.5
                                       and beef replacement          pounds of block) per head
                                       heifers): For increased       per day, at least 1 block
                                       rate of weight gain.          per 5 head of cattle. Feed
                                                                     blocks continuously. Do not
                                                                     feed salt or minerals
                                                                     containing salt. The
                                                                     effectiveness of this block
                                                                     in cull cows and bulls has
                                                                     not been established. See
                                                                     paragraph (d)(10)(i) of
                                                                     this section.
(iv) 400 mg per pound of block        Pasture cattle (slaughter,    Provide 50 to 200 mg of               086113
 (0.088%).                             stocker, feeder, and dairy    monensin (2 to 8 ounces of
                                       and beef replacement          block) per head per day, at
                                       heifers): For increased       least 1 block per 5 head of
                                       rate of weight gain.          cattle. Feed blocks
                                                                     continuously. Do not feed
                                                                     salt or mineral supplements
                                                                     in addition to the blocks.
                                                                     Ingestion by cattle of
                                                                     monensin at levels of 600
                                                                     mg per head per day and
                                                                     higher has been fatal. The
                                                                     effectiveness of this block
                                                                     in cull cows and bulls has
                                                                     not been established. See
                                                                     paragraph (d)(10)(i) of
                                                                     this section.
(v) In free-choice Type C medicated   Growing cattle on pasture or  During the first 5 days of            058198
 feeds to provide 50 to 200 mg per     in dry lot (stocker and       feeding, cattle should
 head per day.                         feeder cattle and dairy and   receive no more than 100
                                       beef replacement heifers):    milligrams per day. Do not
                                       For increased rate of         feed additional salt or
                                       weight gain; for prevention   minerals. Do not mix with
                                       and control of coccidiosis    grain or other feeds.
                                       due to E. bovis and E.        Monensin is toxic to cattle
                                       zuernii.                      when consumed at higher
                                                                     than approved levels.
                                                                     Stressed and/or feed- and/
                                                                     or water-deprived cattle
                                                                     should be adapted to the
                                                                     pasture and to unmedicated
                                                                     supplement before using the
                                                                     monensin medicated
                                                                     supplement. The product's
                                                                     effectiveness in cull cows
                                                                     and bulls has not been
                                                                     established. See paragraph
                                                                     (d) of this section for
                                                                     other required label
                                                                     warnings.
(vi) 1,620 grams per ton of mineral   Growing cattle on pasture or  Feed at a rate of 50 to 200           058198
 granules as specified in paragraph.   in dry lot (stocker and       milligrams per head per
(f)(4)(vi)(A) of this section.......   feeder cattle and dairy and   day. During the first 5
                                       beef replacement heifers):    days of feeding, cattle
                                       For increased rate of         should receive no more than
                                       weight gain, and for          100 milligrams per day. Do
                                       prevention and control of     not feed additional salt or
                                       coccidiosis due to E. bovis   minerals. Do not mix with
                                       and E. zuernii.               grain or other feeds.
                                                                     Monensin is toxic to cattle
                                                                     when consumed at higher
                                                                     than approved levels.
                                                                     Stressed and/or feed- and/
                                                                     or water-deprived cattle
                                                                     should be adapted to the
                                                                     pasture and to unmedicated
                                                                     mineral supplement before
                                                                     using the monensin mineral
                                                                     supplement. The product's
                                                                     effectiveness in cull cows
                                                                     and bulls has not been
                                                                     established.
----------------------------------------------------------------------------------------------------------------


[[Page 487]]

    (A) Specifications. Use as free-choice Type C medicated feed 
formulated as mineral granules as follows:

------------------------------------------------------------------------
                                                           International
               Ingredient                     Percent        feed No.
------------------------------------------------------------------------
Monocalcium phosphate (21% phosphorus,             29.49        6-01-082
 15% calcium)...........................
Sodium chloride (salt)..................           24.37        6-04-152
Dried cane molasses.....................            20.0        4-04-695
Ground limestone (33% calcium) or                  13.75        6-02-632
 calcium carbonate (38% calcium)........
Cane molasses...........................             3.0        4-04-696
Processed grain by-products (as approved             5.0
 by AAFCO)..............................
Vitamin/trace mineral premix \1\........             2.5
Monensin Type A article, 90.7 grams per             0.89
 pound..................................
Antidusting oil.........................             1.0
------------------------------------------------------------------------
\1\ Content of vitamin and trace mineral premixes may be varied.
  However, they should be comparable to those used for other free-choice
  feeds. Formulation modifications require FDA approval prior to
  marketing. Selenium must comply with 21 CFR 573.920. Ethylenediamine
  dihydroiodide (EDDI) should comply with FDA Compliance Policy Guides
  Sec. 651.100 (CPG 7125.18).

    (B) [Reserved]
    (5) Bobwhite quail--

----------------------------------------------------------------------------------------------------------------
        Monensin in grams/ton              Indications for use               Limitations              Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 73..............................  Growing bobwhite quail: For   Feed continuously in                  058198
                                       the prevention of             complete feed at a rate of
                                       coccidiosis caused by         50 to 480 milligrams of
                                       Eimeria dispersa and E.       monensin per head per day.
                                       lettyae.                      No additional improvement
                                                                     in feed efficiency has been
                                                                     shown from feeding monensin
                                                                     at levels greater than 30
                                                                     grams per ton (360
                                                                     milligrams per head per
                                                                     day).
(ii) [Reserved].....................  ............................  ............................  ..............
----------------------------------------------------------------------------------------------------------------

    (6) Goats--

----------------------------------------------------------------------------------------------------------------
        Monensin in grams/ton              Indications for use               Limitations              Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 20..............................  For the prevention of         Feed only to goats being fed          058198
                                       coccidiosis caused by         in confinement. Do not feed
                                       Eimeria crandallis, E.        to lactating goats. See
                                       christenseni, and E.          paragraph (d)(11) of this
                                       ninakohlyakimovae.            section for provisions for
                                                                     monensin liquid Type C goat
                                                                     feeds.
(ii) [Reserved].....................  ............................  ............................  ..............
----------------------------------------------------------------------------------------------------------------

    (7) Monensin may also be used in combination with:
    (i) Avilamycin as in Sec. 558.68.
    (ii) Chlortetracycline as in Sec. 558.128.
    (iii) Decoquinate as in Sec. 558.195.
    (iv) Lubabegron as in Sec. 558.330.
    (v) Lincomycin as in Sec. 558.325.
    (vi) Melengestrol acetate as in Sec. 558.342.
    (vii) Oxytetracycline as in Sec. 558.450.
    (viii) Ractopamine alone or in combination as in Sec. 558.500.
    (ix) Tilmicosin as in Sec. 558.618.
    (x) Tylosin as in Sec. 558.625.
    (xi) Virginiamycin as in Sec. 558.635.
    (xii) Zilpaterol alone or in combination as in Sec. 558.665.

[40 FR 13959, Mar. 27, 1975]

    Editorial Note: For Federal Register citations affecting Sec. 
558.355, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and at www.govinfo.gov.



Sec. 558.360  Morantel.

    (a) Specifications. Each pound of Type A medicated article contains 
88 grams morantel tartrate.
    (b) Sponsor. See No. 066104 in Sec. 510.600(c) of this chapter.

[[Page 488]]

    (c) Related tolerances. See Sec. 556.425 of this chapter.
    (d) Special considerations. (1) Do not use in Type B or Type C 
medicated feeds containing bentonite.
    (2) Consult your veterinarian before using in severely debilitated 
animals and for assistance in the diagnosis, treatment, and control of 
parasitism.
    (e) Conditions of use. It is used in feed as follows:

----------------------------------------------------------------------------------------------------------------
   Morantel tartrate in grams/ton          Indications for use               Limitations              Sponsor
----------------------------------------------------------------------------------------------------------------
(1) 0.44 to 4.4 grams of morantel     Cattle: For removal and       Feed as a single therapeutic          066104
 tartrate per pound of feed.           control of mature             treatment at 0.44 gram of
                                       gastrointestinal nematode     morantel tartrate per 100
                                       infections of cattle          pounds of body weight.
                                       including stomach worms       Fresh water should be
                                       (Haemonchus spp.,             available at all times.
                                       Ostertagia spp.,              When medicated feed is
                                       Trichostrongylus spp.),       consumed, resume normal
                                       worms of the small            feeding. Conditions of
                                       intestine (Cooperia spp.,     constant worm exposure may
                                       Trichostrongylus spp.,        require retreatment in 2 to
                                       Nematodirus spp.), and        4 weeks. Do not treat
                                       worms of the large            cattle within 14 days of
                                       intestine (Oesophagostomum    slaughter.
                                       radiatum).
(2) 0.44 to 4.4 grams of morantel     Goats: For removal and        Feed as a single therapeutic          066104
 tartrate per pound of feed.           control of mature             treatment at 0.44 gram of
                                       gastrointestinal nematode     morantel tartrate per 100
                                       infections of goats           pounds of body weight.
                                       including Haemonchus          Fresh water should be
                                       contortus, Ostertagia         available at all times.
                                       (Teladorsagia)                When medicated feed is
                                       circumcincta, and             consumed, resume normal
                                       Trichostrongylus axei.        feeding. Conditions of
                                                                     constant worm exposure may
                                                                     require retreatment in 2 to
                                                                     4 weeks. Do not treat goats
                                                                     within 30 days of slaughter.
----------------------------------------------------------------------------------------------------------------


[84 FR 39185, Aug. 9, 2019]



Sec. 558.363  Narasin.

    (a) Specifications. Type A medicated articles containing 36, 45, 54, 
72, or 90 grams narasin per pound.
    (b) Sponsor. See No. 058198 in Sec. 510.600(c) of this chapter.
    (c) Tolerances. See Sec. 556.428 of this chapter.
    (d) Special considerations. An expiration date of 2 months (8 weeks) 
is required for narasin Type C medicated swine feeds.
    (e) Conditions of use. It is used as follows:
    (1) Chickens--

----------------------------------------------------------------------------------------------------------------
                                   Combination in grams/
        Narasin  grams/ton                  ton            Indications for use        Limitations       Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 54 to 90.....................  ....................  Broiler chickens: For    For broiler             058198
                                                          prevention of            chickens only.
                                                          coccidiosis caused by    Feed continuously
                                                          Eimeria necatrix, E.     as sole ration. Do
                                                          tenella, E.              not allow adult
                                                          acervulina, E.           turkeys, horses,
                                                          brunetti, E. mivati,     or other equines
                                                          and E. maxima.           access to narasin
                                                                                   formulations.
                                                                                   Ingestion of
                                                                                   narasin by these
                                                                                   species has been
                                                                                   fatal.
(ii) 54 to 72....................  Bacitracin            Broiler chickens: For    For broiler             054771
                                    methylenedisalicyla   prevention of            chickens only.
                                    te, 10 to 50.         coccidiosis caused by    Feed continuously
                                                          Eimeria necatrix, E.     as sole ration. Do
                                                          tenella, E.              not feed to laying
                                                          acervulina, E.           hens. Do not allow
                                                          brunetti, E. mivati,     adult turkeys,
                                                          and E. maxima, and for   horses, or other
                                                          increased rate of        equines access to
                                                          weight gain and          narasin
                                                          improved feed            formulations.
                                                          efficiency.              Ingestion of
                                                                                   narasin by these
                                                                                   species has been
                                                                                   fatal. Bacitracin
                                                                                   methylenedisalicyl
                                                                                   ate as provided by
                                                                                   No. 054771 in Sec.
                                                                                     510.600(c) of
                                                                                   this chapter.

[[Page 489]]

 
(iii) 54 to 72...................  Bacitracin zinc, 4    Broiler chickens: For    For broiler             054771
                                    to 50.                prevention of            chickens only.
                                                          coccidiosis caused by    Feed continuously
                                                          Eimeria necatrix, E.     as sole ration. Do
                                                          tenella, E.              not allow adult
                                                          acervulina, E.           turkeys, horses,
                                                          brunetti, E. mivati,     or other equines
                                                          and E. maxima, and for   access to narasin
                                                          increased rate of        formulations.
                                                          weight gain and          Ingestion of
                                                          improved feed            narasin by these
                                                          efficiency.              species has been
                                                                                   fatal. Bacitracin
                                                                                   zinc as provided
                                                                                   by No. 054771 in
                                                                                   Sec. 510.600(c)
                                                                                   of this chapter.
(iv) 54 to 72....................  Bambermycins, 1 to 2  Broiler chickens: For    For broiler             016592
                                                          prevention of            chickens only.
                                                          coccidiosis caused by    Feed continuously
                                                          Eimeria necatrix, E.     as sole ration. Do
                                                          tenella, E.              not allow adult
                                                          acervulina, E.           turkeys, horses,
                                                          brunetti, E. mivati,     or other equines
                                                          and E. maxima, and for   access to narasin
                                                          increased rate of        formulations.
                                                          weight gain and          Ingestion of
                                                          improved feed            narasin by these
                                                          efficiency.              species has been
                                                                                   fatal.
                                                                                   Bambermycins as
                                                                                   provided by No.
                                                                                   016592 in Sec.
                                                                                   510.600(c) of this
                                                                                   chapter.
----------------------------------------------------------------------------------------------------------------

    (2) Swine--

----------------------------------------------------------------------------------------------------------------
                                   Combination in grams/
        Narasin  grams/ton                  ton            Indications for use        Limitations       Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 13.6 to 27.2.................  ....................  Growing-finishing        Feed continuously       058198
                                                          swine: For increased     for at least 4
                                                          rate of weight gain      weeks to swine
                                                          when fed for at least    during the growing-
                                                          4 weeks.                 finishing period
                                                                                   as the sole
                                                                                   ration. No
                                                                                   increased benefit
                                                                                   in rate of weight
                                                                                   gain has been
                                                                                   shown when narasin
                                                                                   concentrations in
                                                                                   the diet are
                                                                                   greater than 13.6
                                                                                   g/ton.
                                                                                   Effectiveness has
                                                                                   not been
                                                                                   demonstrated when
                                                                                   fed for durations
                                                                                   less than 4 weeks.
                                                                                   Do not allow adult
                                                                                   turkeys, horses,
                                                                                   or other equines
                                                                                   access to narasin
                                                                                   formulations.
                                                                                   Ingestion of
                                                                                   narasin by these
                                                                                   species has been
                                                                                   fatal. Not
                                                                                   approved for use
                                                                                   in breeding
                                                                                   animals because
                                                                                   safety and
                                                                                   effectiveness have
                                                                                   not been evaluated
                                                                                   in these animals.
                                                                                   Swine being fed
                                                                                   with narasin
                                                                                   should not have
                                                                                   access to feeds
                                                                                   containing
                                                                                   pleuromutilins
                                                                                   (e.g., tiamulin)
                                                                                   as adverse
                                                                                   reactions may
                                                                                   occur. If signs of
                                                                                   toxicity occur,
                                                                                   discontinue use.

[[Page 490]]

 
(ii) 18.1 to 27.2................  ....................  Growing-finishing        Feed continuously       058198
                                                          swine: For increased     for at least 4
                                                          rate of weight gain      weeks to swine
                                                          and improved feed        during the growing-
                                                          efficiency when fed      finishing period
                                                          for at least 4 weeks.    as the sole
                                                                                   ration. No
                                                                                   increased benefit
                                                                                   in rate of weight
                                                                                   gain has been
                                                                                   shown when narasin
                                                                                   concentrations in
                                                                                   the diet are
                                                                                   greater than 13.6
                                                                                   g/ton.
                                                                                   Effectiveness has
                                                                                   not been
                                                                                   demonstrated when
                                                                                   fed for durations
                                                                                   less than 4 weeks.
                                                                                   Do not allow adult
                                                                                   turkeys, horses,
                                                                                   or other equines
                                                                                   access to narasin
                                                                                   formulations.
                                                                                   Ingestion of
                                                                                   narasin by these
                                                                                   species has been
                                                                                   fatal. Not
                                                                                   approved for use
                                                                                   in breeding
                                                                                   animals because
                                                                                   safety and
                                                                                   effectiveness have
                                                                                   not been evaluated
                                                                                   in these animals.
                                                                                   Swine being fed
                                                                                   with narasin
                                                                                   should not have
                                                                                   access to feeds
                                                                                   containing
                                                                                   pleuromutilins
                                                                                   (e.g., tiamulin)
                                                                                   as adverse
                                                                                   reactions may
                                                                                   occur. If signs of
                                                                                   toxicity occur,
                                                                                   discontinue use.
----------------------------------------------------------------------------------------------------------------

    (3) Narasin single-ingredient Type A medicated articles may also be 
used in combination with:
    (i) Avilamycin as in Sec. 558.68.
    (ii) [Reserved]

[83 FR 64741, Dec. 18, 2018, as amended at 86 FR 14825, Mar. 19, 2021]



Sec. 558.364  Narasin and nicarbazin.

    (a) Specifications. A fixed-ratio, combination drug Type A medicated 
article containing 36 grams narasin and 36 grams nicarbazin per pound.
    (b) Sponsor. See No. 058198 in Sec. 510.600(c) of this chapter.
    (c) Tolerances. See Sec. Sec. 556.428 and 556.445 of this chapter.
    (d) Conditions of use. It is used as follows:
    (1) Chickens--

----------------------------------------------------------------------------------------------------------------
 Narasin and  nicarbazin  grams/   Combination in grams/
               ton                          ton            Indications for use        Limitations       Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 27 to 45 of each drug........  ....................  Broiler chickens: For    Feed continuously       058198
                                                          prevention of            as the sole
                                                          coccidiosis caused by    ration. Do not
                                                          Eimeria tenella, E.      feed to laying
                                                          necatrix, E.             hens. Do not allow
                                                          acervulina, E. maxima,   adult turkeys,
                                                          E. brunetti, and E.      horses, or other
                                                          mivati.                  equines access to
                                                                                   formulations
                                                                                   containing
                                                                                   narasin. Ingestion
                                                                                   of narasin by
                                                                                   these species has
                                                                                   been fatal. The
                                                                                   two drugs can be
                                                                                   combined only at a
                                                                                   1:1 ratio for the
                                                                                   27 to 45 grams per
                                                                                   ton range. Only
                                                                                   granular
                                                                                   nicarbazin as
                                                                                   provided by No.
                                                                                   058198 in Sec.
                                                                                   510.600(c) of this
                                                                                   chapter may be
                                                                                   used in the
                                                                                   combination.

[[Page 491]]

 
(ii) 27 to 45 of each drug.......  Bacitracin            Broiler chickens: For    Feed continuously       058198
                                    methylenedisalicyla   the prevention of        as sole ration. Do     069254
                                    te, 4 to 50.          coccidiosis caused by    not feed to laying
                                                          Eimeria necatrix, E.     hens. Do not allow
                                                          tenella, E.              turkeys, horses,
                                                          acervulina, E.           or other equines
                                                          brunetti, E. mivati,     access to
                                                          and E. maxima, and for   formulations
                                                          increased rate of        containing
                                                          weight gain and          narasin. Ingestion
                                                          improved feed            of narasin by
                                                          efficiency.              these species has
                                                                                   been fatal. For
                                                                                   No. 054771:
                                                                                   Withdraw 5 days
                                                                                   before slaughter.
                                                                                   For No. 069254:
                                                                                   Zero withdrawal
                                                                                   period. Bacitracin
                                                                                   methylenedisalicyl
                                                                                   ate as provided by
                                                                                   Nos. 054771 and
                                                                                   069254 in Sec.
                                                                                   510.600(c) of this
                                                                                   chapter.
(iii) 27 to 45 of each drug......  Bacitracin            Broiler chickens: For    Feed continuously       054771
                                    methylenedisalicyla   prevention of            as sole ration.
                                    te, 50.               coccidiosis caused by    Withdraw 5 days
                                                          Eimeria tenella, E.      before slaughter.
                                                          necatrix, E.             Do not feed to
                                                          acervulina, E. maxima,   laying hens. Do
                                                          E. brunetti, and E.      not allow turkeys,
                                                          mivati, and as an aid    horses, or other
                                                          in the prevention of     equines access to
                                                          necrotic enteritis       formulations
                                                          caused or complicated    containing
                                                          by Clostridium spp. or   narasin. Ingestion
                                                          other organisms          of narasin by
                                                          susceptible to           these species has
                                                          bacitracin.              been fatal.
                                                                                   Bacitracin
                                                                                   methylenedisalicyl
                                                                                   ate as provided by
                                                                                   No. 054771 in Sec.
                                                                                     510.600(c) of
                                                                                   this chapter.
(iv) 27 to 45 of each drug.......  Bacitracin            Broiler chickens: For    To control necrotic     054771
                                    methylenedisalicyla   prevention of            enteritis, start
                                    te, 100 to 200.       coccidiosis caused by    medication at
                                                          Eimeria tenella, E.      first clinical
                                                          necatrix, E.             signs of disease;
                                                          acervulina, E. maxima,   vary dosage based
                                                          E. brunetti, and E.      on the severity of
                                                          mivati, and as an aid    infection;
                                                          in the control of        administer
                                                          necrotic enteritis       continuously for 5
                                                          caused or complicated    to 7 days or as
                                                          by Clostridium spp. or   long as clinical
                                                          other organisms          signs persist,
                                                          susceptible to           then reduce
                                                          bacitracin.              bacitracin to
                                                                                   prevention level
                                                                                   (50 g/ton). Do not
                                                                                   feed to laying
                                                                                   hens. Withdraw 5
                                                                                   days before
                                                                                   slaughter. Do not
                                                                                   allow turkeys,
                                                                                   horses, or other
                                                                                   equines access to
                                                                                   formulations
                                                                                   containing
                                                                                   narasin. Ingestion
                                                                                   of narasin by
                                                                                   these species has
                                                                                   been fatal.
                                                                                   Bacitracin
                                                                                   methylenedisalicyl
                                                                                   ate as provided by
                                                                                   No. 054771 in Sec.
                                                                                     510.600(c) of
                                                                                   this chapter.
(v) 27 to 45 of each drug........  Bambermycins, 1 to 2  Broiler chickens: As an  Feed continuously       058198
                                                          aid in preventing        as sole ration
                                                          outbreaks of cecal       from time chicks
                                                          (Eimeria tenella) and    are placed on
                                                          intestinal (E.           litter until past
                                                          acervulina, E. maxima,   the time when
                                                          E. necatrix, and E.      coccidiosis is
                                                          brunetti) coccidiosis,   ordinarily a
                                                          and for increased rate   hazard. Do not use
                                                          of weight gain and       as a treatment for
                                                          improved feed            coccidiosis. Do
                                                          efficiency.              not feed to laying
                                                                                   hens. Withdraw 5
                                                                                   days before
                                                                                   slaughter. Do not
                                                                                   allow turkeys,
                                                                                   horses, or other
                                                                                   equines access to
                                                                                   formulations
                                                                                   containing
                                                                                   narasin. Ingestion
                                                                                   of narasin by
                                                                                   these species has
                                                                                   been fatal.
                                                                                   Bambermycins as
                                                                                   provided by No.
                                                                                   016592 in Sec.
                                                                                   510.600(c) of this
                                                                                   chapter.
----------------------------------------------------------------------------------------------------------------

    (2) Narasin and nicarbazin fixed-ratio, combination drug Type A 
medicated articles may also be used in combination with:
    (i) Avilamycin as in Sec. 558.68.

[[Page 492]]

    (ii) [Reserved]

[83 FR 64742, Dec. 18, 2018, as amended at 84 FR 8981, Mar. 13, 2019; 86 
FR 14825, Mar. 19, 2021]



Sec. 558.365  Neomycin sulfate.

    (a) Specifications. Type A medicated article containing 325 grams 
neomycin sulfate per pound.
    (b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
    (c) Related tolerances. See Sec. 556.430 of this chapter.
    (d) Special considerations. (1) Federal law restricts medicated feed 
containing this veterinary feed directive (VFD) drug to use by or on the 
order of a licensed veterinarian. See Sec. 558.6 for additional 
requirements.
    (2) The expiration date of VFDs for neomycin medicated feeds must 
not exceed 6 months from the date of issuance. VFDs for neomycin shall 
not be refilled.
    (e) Conditions of use. Neomycin sulfate is used as follows:

----------------------------------------------------------------------------------------------------------------
         Neomycin Sulfate               Combination        Indications for Use        Limitations       Sponsor
----------------------------------------------------------------------------------------------------------------
(1) 250 to 2,250 grams per ton (g/ ....................  Cattle, swine, sheep,    To provide 10           054771
 t) of dry type C feed..                                  and goats. For           milligrams (mg) of
                                                          treatment and control    neomycin sulfate
                                                          of colibacillosis        per pound of body
                                                          (bacterial enteritis)    weight per day for
                                                          caused by Escherichia    a maximum of 14
                                                          coli susceptible to      days. The
                                                          neomycin..               concentration of
                                                                                   neomycin sulfate
                                                                                   required in
                                                                                   medicated feed
                                                                                   must be adjusted
                                                                                   to compensate for
                                                                                   variation in age
                                                                                   and weight of
                                                                                   animal, the nature
                                                                                   and severity of
                                                                                   disease signs, and
                                                                                   environmental
                                                                                   temperature and
                                                                                   humidity, each of
                                                                                   which affects feed
                                                                                   consumption. If
                                                                                   symptoms persist
                                                                                   after using for 2
                                                                                   or 3 days, consult
                                                                                   a veterinarian.
                                                                                   Treatment should
                                                                                   continue 24 to 48
                                                                                   hours beyond
                                                                                   remission of
                                                                                   disease symptoms.
                                                                                   Discontinue
                                                                                   treatment prior to
                                                                                   slaughter as
                                                                                   follows: Cattle 1
                                                                                   day, swine 3 days,
                                                                                   sheep 2 days, and
                                                                                   goats 3 days. A
                                                                                   withdrawal period
                                                                                   has not been
                                                                                   established for
                                                                                   use in
                                                                                   preruminating
                                                                                   calves. Do not use
                                                                                   in calves to be
                                                                                   processed for
                                                                                   veal. A milk
                                                                                   discard time has
                                                                                   not been
                                                                                   established for
                                                                                   use in lactating
                                                                                   dairy cattle or
                                                                                   lactating dairy
                                                                                   goats. Do not use
                                                                                   in female dairy
                                                                                   cattle 20 months
                                                                                   of age or older or
                                                                                   female dairy goats
                                                                                   12 months of age
                                                                                   or older. For use
                                                                                   in dry feeds only.
                                                                                   Not for use in
                                                                                   liquid feed
                                                                                   supplements..

[[Page 493]]

 
(2) 400 to 2,000 g/t of type C     ....................  Do.....................  To provide 10 mg of     054771
 milk replacer..                                                                   neomycin sulfate
                                                                                   per pound of body
                                                                                   weight per day for
                                                                                   a maximum of 14
                                                                                   days. Amount
                                                                                   consumed will vary
                                                                                   depending on
                                                                                   animal's
                                                                                   consumption and
                                                                                   weight. If
                                                                                   symptoms persist
                                                                                   after using for 2
                                                                                   or 3 days, consult
                                                                                   a veterinarian.
                                                                                   Treatment should
                                                                                   continue 24 to 48
                                                                                   hours beyond
                                                                                   remission of
                                                                                   disease symptoms.
                                                                                   Discontinue
                                                                                   treatment prior to
                                                                                   slaughter as
                                                                                   follows: Cattle 1
                                                                                   day, swine 3 days,
                                                                                   sheep 2 days, and
                                                                                   goats 3 days. A
                                                                                   withdrawal period
                                                                                   has not been
                                                                                   established for
                                                                                   use in
                                                                                   preruminating
                                                                                   calves. Do not use
                                                                                   in calves to be
                                                                                   processed for
                                                                                   veal. A milk
                                                                                   discard time has
                                                                                   not been
                                                                                   established for
                                                                                   use in lactating
                                                                                   dairy cattle or
                                                                                   lactating dairy
                                                                                   goats. Do not use
                                                                                   in female dairy
                                                                                   cattle 20 months
                                                                                   of age or older or
                                                                                   female dairy goats
                                                                                   12 months of age
                                                                                   or older. For use
                                                                                   in milk replacers
                                                                                   only..
----------------------------------------------------------------------------------------------------------------


[64 FR 70576, Dec. 17, 1999, as amended at 65 FR 45881, July 26, 2000; 
79 FR 13545, Mar. 11, 2014; 81 FR 95009, Dec. 27, 2016. Redesignated at 
83 FR 64742, Dec. 18, 2018]



Sec. 558.366  Nicarbazin.

    (a) Specifications. Type A medicated articles containing 25 percent 
nicarbazin.
    (b) Sponsors. See Nos. 058198, 060728, and 066104 in Sec. 
510.600(c) of this chapter.
    (c) Related tolerances. See Sec. 556.445 of this chapter.
    (d) Conditions of use. It is used as follows:
    (1) Chickens--

----------------------------------------------------------------------------------------------------------------
  Nicarbazin in  grams per    Combination  in grams
            ton                      per ton           Indications for use           Limitations         Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 90.8 to 181.6..........  ......................  Broiler chickens: As    Feed continuously as sole    066104
                                                      an aid in preventing    ration from time chicks
                                                      outbreaks of cecal      are placed on litter
                                                      (Eimeria tenella) and   until past the time when
                                                      intestinal (E.          coccidiosis is ordinarily
                                                      acervulina, E.          a hazard. Do not use as a
                                                      maxima, E. necatrix,    treatment for outbreaks
                                                      and E. brunetti)        of coccidiosis. Do not
                                                      coccidiosis.            use in flushing mashes.
                                                                              Do not feed to laying
                                                                              hens. Withdraw 4 days
                                                                              before slaughter for use
                                                                              levels at or below 113.5
                                                                              g/ton. Withdraw 5 days
                                                                              before slaughter for use
                                                                              levels above 113.5 g/ton.

[[Page 494]]

 
(ii) 90.8 to 181.6.........  Bacitracin              Broiler chickens: As    Feed continuously as sole    054771
                              methylenedisalicylate   an aid in preventing    ration from time chicks
                              , 4 to 50.              outbreaks of cecal      are placed on litter
                                                      (Eimeria tenella) and   until past the time when
                                                      intestinal (E.          coccidiosis is ordinarily
                                                      acervulina, E.          a hazard. Do not use as a
                                                      maxima, E. necatrix,    treatment for outbreaks
                                                      and E. brunetti)        of coccidiosis. Do not
                                                      coccidiosis, and for    use in flushing mashes.
                                                      increased rate of       Do not feed to laying
                                                      weight gain and         hens. Withdraw 4 days
                                                      improved feed           before slaughter for use
                                                      efficiency.             levels at or below 113.5
                                                                              g/ton. Withdraw 5 days
                                                                              before slaughter for use
                                                                              levels above 113.5 g/ton.
                                                                              Nicarbazin as provided by
                                                                              No. 066104; bacitracin
                                                                              methylenedisalicylate as
                                                                              provided by No. 054771 in
                                                                              Sec. 510.600(c) of this
                                                                              chapter.
(iii) 90.8 to 181.6........  Bacitracin              Broiler chickens; As    Feed continuously as sole    066104
                              methylenedisalicylate   an aid in preventing    ration from time chicks
                              , 30.                   outbreaks of cecal      are placed on litter
                                                      (Eimeria tenella) and   until past the time when
                                                      intestinal (E.          coccidiosis is ordinarily
                                                      acervulina, E.          a hazard. Do not use as a
                                                      maxima, E. necatrix,    treatment for
                                                      and E. brunetti)        coccidiosis. Do not use
                                                      coccidiosis, and for    in flushing mashes. Do
                                                      increased rate of       not feed to laying hens.
                                                      weight gain and         Withdraw 4 days before
                                                      improved feed           slaughter for use levels
                                                      efficiency.             at or below 113.5 g/ton.
                                                                              Withdraw 5 days before
                                                                              slaughter for use levels
                                                                              above 113.5 g/ton.
                                                                              Nicarbazin as provided by
                                                                              No. 066104; bacitracin
                                                                              methylenedisalicylate as
                                                                              provided by No. 054771 in
                                                                              Sec. 510.600(c) of this
                                                                              chapter.
(iv) 90.8 to 181.6.........  Bacitracin              Broiler chickens: As    Feed continuously as sole    054771
                              methylenedisalicylate   an aid in preventing    ration from time chicks
                              50.                     outbreaks of cecal      are placed on litter
                                                      (Eimeria tenella) and   until past the time when
                                                      intestinal (E.          coccidiosis is ordinarily
                                                      acervulina, E.          a hazard. Do not use as a
                                                      maxima, E. necatrix,    treatment for outbreaks
                                                      and E. brunetti)        of coccidiosis. Do not
                                                      coccidiosis, and as     use in flushing mashes.
                                                      an aid in the           Do not feed to laying
                                                      prevention of           hens. Withdraw 4 days
                                                      necrotic enteritis      before slaughter for use
                                                      caused or complicated   levels at or below 113.5
                                                      by Clostridium spp.     g/ton. Withdraw 5 days
                                                      or other organisms      before slaughter for use
                                                      susceptible to          levels above 113.5 g/ton.
                                                      bacitracin.             Nicarbazin as provided by
                                                                              No. 066104; bacitracin
                                                                              methylenedisalicylate as
                                                                              provided by No. 054771 in
                                                                              Sec. 510.600(c) of this
                                                                              chapter.

[[Page 495]]

 
(v) 113.5..................  ......................  Chickens: As an aid in  Feed continuously as sole    058198
                                                      preventing outbreaks    ration from time chicks     060728
                                                      of cecal (Eimeria       are placed on litter
                                                      tenella) and            until past the time when
                                                      intestinal (E.          coccidiosis is ordinarily
                                                      acervulina, E.          a hazard. Do not use as a
                                                      maxima, E. necatrix,    treatment for
                                                      and E. brunetti)        coccidiosis. Do not use
                                                      coccidiosis.            in flushing mashes. Do
                                                                              not feed to laying hens.
                                                                              Withdraw 4 days before
                                                                              slaughter.
(vi) 113.5.................  Bacitracin              Broiler chickens; aid   Feed continuously as sole    060728
                              methylenedisalicylate   in preventing           ration from time chicks
                              , 30.                   outbreaks of cecal      are placed on litter
                                                      (Eimeria tenella) and   until past the time when
                                                      intestinal (E.          coccidiosis is ordinarily
                                                      acervulina, E.          a hazard. Do not use as a
                                                      maxima, E. necatrix,    treatment for
                                                      and E. brunetti)        coccidiosis. Do not use
                                                      coccidiosis, and for    in flushing mashes. Do
                                                      increased rate of       not feed to laying hens.
                                                      weight gain and         Withdraw 4 days before
                                                      improved feed           slaughter. Nicarbazin as
                                                      efficiency.             provided by No. 066104;
                                                                              bacitracin
                                                                              methylenedisalicylate as
                                                                              provided by No. 054771 in
                                                                              Sec. 510.600(c) of this
                                                                              chapter.
(vii) 113.5................  Bacitracin zinc, 4 to   Broiler chickens; aid   For broiler chickens only.   054771
                              50.                     in preventing           Feed continuously as sole   066104
                                                      outbreaks of cecal      ration from time chicks
                                                      (Eimeria tenella) and   are placed on litter
                                                      intestinal (E.          until past the time when
                                                      acervulina, E.          coccidiosis is ordinarily
                                                      maxima, E. necatrix,    a hazard. Do not use in
                                                      and E. brunetti)        flushing mashes. Do not
                                                      coccidiosis, and for    feed to laying hens.
                                                      increased rate of       Withdraw 4 days before
                                                      weight gain and         slaughter. Nicarbazin as
                                                      improved feed           provided by No. 066104,
                                                      efficiency.             bacitracin zinc as
                                                                              provided by No. 054771 in
                                                                              Sec. 510.600(c) of this
                                                                              chapter.
(viii) 113.5...............  Bambermycins, 1 to 2..  Broiler chickens: As    Feed continuously as sole    016592
                                                      an aid in preventing    ration from time chicks
                                                      outbreaks of cecal      are placed on litter
                                                      (Eimeria tenella) and   until past the time when
                                                      intestinal (E.          coccidiosis is ordinarily
                                                      acervulina, E.          a hazard; do not use as a
                                                      maxima, E. necatrix,    treatment for
                                                      and E. brunetti)        coccidiosis. Do not use
                                                      coccidiosis, and for    in flushing mashes. Do
                                                      increased rate of       not feed to laying hens.
                                                      weight gain and         Withdraw 4 days before
                                                      improved feed           slaughter. Nicarbazin as
                                                      efficiency.             provided by No. 066104;
                                                                              bambermycins as provided
                                                                              by No. 016592 in Sec.
                                                                              510.600(c) of this
                                                                              chapter.
----------------------------------------------------------------------------------------------------------------

    (2) [Reserved]

[83 FR 64743, Dec. 18, 2018, as amended at 86 FR 14825, Mar. 19, 2021]



Sec. 558.415  Novobiocin.

    (a) Specifications. Type A medicated article containing 25 grams of 
novobiocin activity per pound.
    (b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.

[[Page 496]]

    (c) Related tolerances. See Sec. 556.460 of this chapter.
    (d) Conditions of use. It is used in animal feeds as follows:
    (1) Chickens--

----------------------------------------------------------------------------------------------------------------
    Novobiocin amount              Indications for use                      Limitations                Sponsor
----------------------------------------------------------------------------------------------------------------
(i) To provide 6 to 7      Chickens: As an aid in the           Administer feed which contains not        054771
 milligrams per pound (mg/  treatment of breast blisters         less than 200 grams of novobiocin
 lb) of body weight per     associated with staphylococcal       activity per ton of feed as the
 day.                       infections susceptible to            sole ration for 5 to 7 days. Not
                            novobiocin.                          for laying chickens. Withdraw 4
                                                                 days before slaughter.
(ii) To provide 10 to 14   Chickens: For the treatment of       Administer feed which contains not        054771
 mg/lb of body weight per   staphylococcal synovitis and         less than 350 grams of novobiocin
 day.                       generalized staphylococcal           activity per ton of feed as the
                            infections susceptible to            sole ration for 5 to 7 days. Not
                            novobiocin.                          for laying chickens. Withdraw 4
                                                                 days before slaughter.
----------------------------------------------------------------------------------------------------------------

    (2) Turkeys--

----------------------------------------------------------------------------------------------------------------
    Novobiocin amount              Indications for use                      Limitations                Sponsor
----------------------------------------------------------------------------------------------------------------
(i) To provide 4 to 5 mg/  Turkeys: As an aid in the treatment  Administer feed which contains not        054771
 lb of body weight per      of breast blisters associated with   less than 200 grams of novobiocin
 day.                       staphylococcal infections            activity per ton of feed as the
                            susceptible to novobiocin.           sole ration for 5 to 7 days. Not
                                                                 for laying turkeys. Withdraw 4
                                                                 days before slaughter.
(ii) To provide 5 to 8 mg/ Turkeys: As an aid in the control    Administer feed which contains not        054771
 lb of body weight per      of recurring outbreaks of fowl       less than 200 grams of novobiocin
 day.                       cholera caused by strains of         activity per ton of feed as the
                            Pasteurella multocida susceptible    sole ration for 5 to 7 days. Not
                            to novobiocin following initial      for laying turkeys. Withdraw 4
                            treatment with 7 to 8 mg/lb of       days before slaughter.
                            body weight per day.
(iii) To provide 7 to 8    Turkeys: For the treatment of        Administer feed which contains not        054771
 mg/lb of body weight per   staphylococcal synovitis and         less than 350 grams of novobiocin
 day.                       generalized staphylococcal           activity per ton of feed as the
                            infections susceptible to            sole ration for 5 to 7 days. Not
                            novobiocin; and treatment of acute   for laying turkeys. Withdraw 4
                            outbreaks of fowl cholera caused     days before slaughter.
                            by strains of Pasteurella
                            multocida susceptible to
                            novobiocin.
----------------------------------------------------------------------------------------------------------------

    (3) Minor species--

----------------------------------------------------------------------------------------------------------------
    Novobiocin amount              Indications for use                      Limitations                Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 350 grams per ton.     Ducks: For the control of            Administer as the sole ration for 5       054771
                            infectious serositis and fowl        to 7 days. Continue medication for
                            cholera in ducks caused by           14 days if necessary. Repeat if
                            Pasteurella anatipestifer and P.     reinfection occurs. Discontinue
                            multocida, susceptible to            use at least 3 days before
                            novobiocin.                          slaughter. Not for use in laying
                                                                 ducks.
(ii) To provide 20 mg/lb   Mink: For the treatment of           Administer feed which contains not        054771
 of body weight per day.    generalized infections, abscesses,   less than 200 grams of novobiocin
                            or urinary infections caused by      activity per ton of feed as the
                            staphylococcal or other novobiocin   sole ration for 7 days.
                            sensitive organisms.
----------------------------------------------------------------------------------------------------------------


[40 FR 13959, Mar. 27, 1975, as amended at 45 FR 42263, June 24, 1980; 
51 FR 7399, Mar. 3, 1986; 52 FR 36402, Sept. 29, 1987; 79 FR 13545, Mar. 
11, 2014; 84 FR 12501, Apr. 2, 2019]



Sec. 558.430  Nystatin.

    (a) Specifications. Type A medicated article containing 20 grams of 
nystatin activity per pound.
    (b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
    (c) Related tolerances. See Sec. 556.470 of this chapter.
    (d) Conditions of use--

[[Page 497]]



----------------------------------------------------------------------------------------------------------------
        Amount in grams/ton                Indications for use                  Limitations             Sponsor
----------------------------------------------------------------------------------------------------------------
(1) 50.............................  Growing and laying chickens and  ..............................      054771
                                      growing turkeys: As an aid in
                                      the control of crop mycosis
                                      and mycotic diarrhea (Candida
                                      albicans).
(2) 100............................  Growing and laying chickens and  To be fed for 7 to 10 days....      054771
                                      growing turkeys: For the
                                      treatment of crop mycosis and
                                      mycotic diarrhea (Candida
                                      albicans).
----------------------------------------------------------------------------------------------------------------


[41 FR 11002, Mar. 15, 1976, as amended at 51 FR 7399, Mar. 3, 1986; 52 
FR 2686, Jan. 26, 1987; 53 FR 40729, Oct. 18, 1988; 55 FR 8461, Mar. 8, 
1990; 57 FR 8578, Mar. 11, 1992; 79 FR 13545, Mar. 11, 2014; 85 FR 
45310, July 28, 2020]



Sec. 558.450  Oxytetracycline.

    (a) Specifications. Each pound of Type A medicated article contains:
    (1) Oxytetracycline (from oxytetracycline quaternary salt) 
equivalent to 50 or 100 grams oxytetracycline hydrochloride; or 
oxytetracycline (from oxytetracycline dihydrate base) equivalent to 10, 
30, 50, 100, or 200 grams oxytetracycline hydrochloride.
    (2) Oxytetracycline (from oxytetracycline dihydrate base) equivalent 
to 50, 100, or 200 grams oxytetracycline hydrochloride; or 100 grams 
oxytetracycline hydrochloride.
    (b) Sponsors. See sponsors in Sec. 510.600(c) of this chapter as 
follows:
    (1) No. 066104: Type A medicated articles as in paragraph (a)(1) of 
this section.
    (2) No. 069254: Type A medicated articles as in paragraph (a)(2) of 
this section.
    (c) Related tolerances. See Sec. 556.500 of this chapter.
    (d) Special considerations. (1) Federal law restricts medicated feed 
containing this veterinary feed directive (VFD) drug to use by or on the 
order of a licensed veterinarian. See Sec. 558.6 for additional 
requirements.
    (2) The expiration date of VFDs for oxytetracycline medicated feeds 
must not exceed 6 months from the date of issuance. VFDs for 
oxytetracycline shall not be refilled.
    (3) In accordance with Sec. 558.5, labeling shall bear the 
statement: ``For use in dry animal feed only. Not for use in liquid feed 
supplements.''
    (e) Conditions of use--(1) Chickens--

----------------------------------------------------------------------------------------------------------------
                                     Combination in
     Oxytetracycline amount            grams/ton        Indications for use      Limitations          Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 100 to 200 g/ton............  ...................  Chickens: For         Feed continuously            066104
                                                        control of            for 7 to 14 days.           069254
                                                        infectious            Do not feed to
                                                        synovitis caused by   chickens producing
                                                        Mycoplasma synoviae   eggs for human
                                                        and control of fowl   consumption. Do
                                                        cholera caused by     not use in feed
                                                        Pasteurella           containing less
                                                        multocida             than 0.55% dietary
                                                        susceptible to        calcium. Use in
                                                        oxytetracycline.      such low calcium
                                                                              feeds may result
                                                                              in violative
                                                                              residues. Zero-day
                                                                              withdrawal period.
(ii) 200 g/ton..................  Monensin, 90 to 110  Broiler chickens: As  Feed continuously            066104
                                                        an aid in the         as the sole
                                                        prevention of         ration. Do not
                                                        coccidiosis caused    feed to laying
                                                        by Eimeria            chickens. Do not
                                                        necatrix, E.          feed to chickens
                                                        tenella, E.           over 16 weeks of
                                                        acervulina, E.        age. Do not use in
                                                        brunetti, E.          feed containing
                                                        mivati, and E.        less than 0.55%
                                                        maxima; and for the   dietary calcium.
                                                        control of            Use in such low
                                                        complicated chronic   calcium feeds may
                                                        respiratory disease   result in
                                                        (CRD or air sac       violative
                                                        infection) caused     residues. Withdraw
                                                        by Mycoplasma         72 hours before
                                                        gallisepticum and     slaughter. See
                                                        Escherichia coli.     Sec. 558.355(d)
                                                                              of this chapter
                                                                              Oxytetracycline as
                                                                              provided by No.
                                                                              066104; monensin
                                                                              as provided by No.
                                                                              058198 in Sec.
                                                                              510.600(c) of this
                                                                              chapter.

[[Page 498]]

 
(iii) 400 g/ton.................  ...................  Chickens: For         Feed continuously            066104
                                                        control of chronic    for 7 to 14 days.           069254
                                                        respiratory disease   Do not feed to
                                                        (CRD) and air sac     chickens producing
                                                        infection caused by   eggs for human
                                                        Mycoplasma            consumption. Do
                                                        gallisepticum and     not use in feed
                                                        Escherichia coli      containing less
                                                        susceptible to        than 0.55% dietary
                                                        oxytetracycline.      calcium. Use in
                                                                              such low calcium
                                                                              feeds may result
                                                                              in violative
                                                                              residues. Zero-day
                                                                              withdrawal period.
(iv) 400 g/ton..................  Robenidine, 30.....  Broiler chickens: As  Feed continuously            066104
                                                        an aid in the         for 7 to 14 days.
                                                        prevention of         Do not feed to
                                                        coccidiosis caused    chickens producing
                                                        by Eimeria            eggs for human
                                                        necatrix, E.          consumption. Do
                                                        tenella, E.           not use in feed
                                                        acervulina, E.        containing less
                                                        brunetti, E.          than 0.55% dietary
                                                        mivati, and E.        calcium. Use in
                                                        maxima; and for the   such low calcium
                                                        control of chronic    feeds may result
                                                        respiratory disease   in violative
                                                        (CRD) and air sac     residues. Withdraw
                                                        infection caused by   5 days before
                                                        Mycoplasma            slaughter.
                                                        gallisepticum and     Oxytetracycline as
                                                        Escherichia coli      provided by No.
                                                        susceptible to        066104; robenidine
                                                        oxytetracycline.      as provided by No.
                                                                              054771 in Sec.
                                                                              510.600(c) of this
                                                                              chapter.
(v) 500 g/ton...................  ...................  Chickens: For         Feed continuously            066104
                                                        reduction of          for 5 days. Do not          069254
                                                        mortality due to      feed to chickens
                                                        air sacculitis (air   producing eggs for
                                                        sac infection)        human consumption.
                                                        caused by E. coli     Do not use in feed
                                                        susceptible to        containing less
                                                        oxytetracycline.      than 0.55% dietary
                                                                              calcium. Use in
                                                                              such low calcium
                                                                              feeds may result
                                                                              in violative
                                                                              residues. Withdraw
                                                                              24 hours before
                                                                              slaughter.
(vi) 500 g/ton..................  Monensin, 90 to 100  Broiler chickens: As  Feed for 5 days as           066104
                                                        an aid in the         the sole ration.
                                                        prevention of         Treat at first
                                                        coccidiosis caused    clinical signs of
                                                        by Eimeria            the disease. Do
                                                        necatrix, E.          not feed to laying
                                                        tenella, E.           chickens. Do not
                                                        acervulina, E.        feed to chickens
                                                        brunetti, E.          over 16 weeks of
                                                        mivati, and E.        age. Do not use in
                                                        maxima; and as an     feed containing
                                                        aid in the            less than 0.55%
                                                        reduction of          dietary calcium.
                                                        mortality due to      Use in such low
                                                        air-sacculitis (air   calcium feeds may
                                                        sac infection)        result in
                                                        caused by             violative
                                                        Escherichia coli      residues. Withdraw
                                                        sensitive to          72 hours before
                                                        oxytetracycline.      slaughter. See
                                                                              Sec. 558.355(d)
                                                                              of this chapter.
                                                                              Oxytetracycline as
                                                                              provided by No.
                                                                              066104; monensin
                                                                              as provided by No.
                                                                              058198 in Sec.
                                                                              510.600(c) of this
                                                                              chapter.
(vii) 500 g/ton.................  Salinomycin, 40 to   Chickens: For the     Feed for 5 days as           066104
                                   60.                  prevention of         the sole ration.            016592
                                                        coccidiosis caused    Treat at first
                                                        by Eimeria            clinical signs of
                                                        necatrix, E.          the disease. Do
                                                        tenella, E.           not feed to laying
                                                        acervulina, E.        chickens. Do not
                                                        brunetti, E.          use in feed
                                                        mivati, and E.        containing less
                                                        maxima; and as an     than 0.55% dietary
                                                        aid in the            calcium. Use in
                                                        reduction of          such low calcium
                                                        mortality due to      feeds may result
                                                        air-sacculitis (air   in violative
                                                        sac infection)        residues. Withdraw
                                                        caused by E. coli     24 hours before
                                                        sensitive to          slaughter.
                                                        oxytetracycline.      Oxytetracycline as
                                                                              provided by No.
                                                                              066104;
                                                                              salinomycin as
                                                                              provided by No.
                                                                              016592 in Sec.
                                                                              510.600(c) of this
                                                                              chapter.
----------------------------------------------------------------------------------------------------------------

    (2) Turkeys--

[[Page 499]]



----------------------------------------------------------------------------------------------------------------
         Oxytetracycline amount              Indications for use              Limitations             Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 100 g/ton..........................  Turkeys: For control of      Feed continuously for 7 to          066104
                                          hexamitiasis caused by       14 days. Do not feed to            069254
                                          Hexamita meleagridis         turkeys producing eggs
                                          susceptible to               for human consumption.
                                          oxytetracycline.             Zero-day withdrawal
                                                                       period.
(ii) 200 g/ton.........................  Turkeys: For control of      Feed continuously for 7 to          066104
                                          infectious synovitis         14 days. Do not feed to            069254
                                          caused by M. synoviae        turkeys producing eggs
                                          susceptible to               for human consumption.
                                          oxytetracycline.             For No. 066104, withdraw
                                                                       5 days before slaughter.
                                                                       For No. 069254, zero-day
                                                                       withdrawal period.
(iii) 25 mg/lb of body weight daily....  Turkeys: For control of      Feed continuously for 7 to          066104
                                          complicating bacterial       14 days. Do not feed to            069254
                                          organisms associated with    turkeys producing eggs
                                          bluecomb (transmissible      for human consumption.
                                          enteritis; coronaviral       For No. 066104, withdraw
                                          enteritis) susceptible to    5 days before slaughter.
                                          oxytetracycline.             For No. 069254, zero-day
                                                                       withdrawal period.
----------------------------------------------------------------------------------------------------------------

    (3) Swine--

----------------------------------------------------------------------------------------------------------------
                                     Combination in
     Oxytetracycline amount            grams/ton        Indications for use      Limitations          Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 10 mg/lb of body weight       ...................  1. Swine: For         Feed continuously            066104
 daily.                                                 treatment of          for 7 to 14 days.           069254
                                                        bacterial enteritis
                                                        caused by
                                                        Escherichia coli
                                                        and Salmonella
                                                        choleraesuis
                                                        susceptible to
                                                        oxytetracycline and
                                                        treatment of
                                                        bacterial pneumonia
                                                        caused by
                                                        Pasteurella
                                                        multocida
                                                        susceptible to
                                                        oxytetracycline.
                                                       2. Breeding swine:    Feed continuously            066104
                                                        For control and       for 14 days.                069254
                                                        treatment of
                                                        leptospirosis
                                                        (reducing the
                                                        incidence of
                                                        abortion and
                                                        shedding of
                                                        leptospirae) caused
                                                        by Leptospira
                                                        pomona susceptible
                                                        to oxytetracycline.
(ii) 10 mg/lb of body weight      Carbadox, 10 to 25.  Swine: For treatment  Feed continuously            066104
 daily.                                                 of bacterial          as the sole ration
                                                        enteritis caused by   for 7 to 14 days.
                                                        E. coli and           Not for use in
                                                        Salmonella            pregnant swine or
                                                        choleraesuis          swine intended for
                                                        susceptible to        breeding purposes.
                                                        oxytetracycline and   Do not mix in
                                                        treatment of          feeds containing
                                                        bacterial pneumonia   bentonite. Do not
                                                        caused by             feed to swine
                                                        Pasteurella           within 42 days of
                                                        multocida             slaughter.
                                                        susceptible to        Oxytetracycline
                                                        oxytetracycline;      and carbadox as
                                                        and for increased     provided by No.
                                                        rate of weight gain   066104 in Sec.
                                                        and improved feed     510.600(c) of this
                                                        efficiency.           chapter.
----------------------------------------------------------------------------------------------------------------

    (4) Cattle--

----------------------------------------------------------------------------------------------------------------
                                     Combination in
     Oxytetracycline amount            grams/ton        Indications for use      Limitations          Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 10 mg/lb of body weight       ...................  1. Calves and beef    Feed continuously            066104
 daily.                                                 and nonlactating      for 7 to 14 days.           069254
                                                        dairy cattle: For     For No. 069254,
                                                        treatment of          withdraw 5 days
                                                        bacterial enteritis   before slaughter.
                                                        caused by             For No. 066104,
                                                        Escherichia coli      zero-day
                                                        and bacterial         withdrawal period.
                                                        pneumonia (shipping
                                                        fever complex)
                                                        caused by
                                                        Pasteurella
                                                        multocida
                                                        susceptible to
                                                        oxytetracycline.

[[Page 500]]

 
                                                       2. Calves: For        Feed continuously            066104
                                                        treatment of          for 7 to 14 days            069254
                                                        bacterial enteritis   in milk replacer
                                                        caused by E. coli     or starter feed.
                                                        susceptible to        This product is
                                                        oxytetracycline.      not approved for
                                                                              use in female
                                                                              dairy cattle 20
                                                                              months of age or
                                                                              older, including
                                                                              dry dairy cows.
                                                                              Use in these
                                                                              cattle may cause
                                                                              drug residues in
                                                                              milk and/or in
                                                                              calves born to
                                                                              these cows. For
                                                                              No. 069254,
                                                                              withdraw 5 days
                                                                              before slaughter.
                                                                              For No. 066104,
                                                                              zero-day
                                                                              withdrawal period.
(ii) 75 mg/head/day.............  ...................  Growing cattle (over  Feed continuously..          066104
                                                        400 lb): For                                      069254
                                                        reduction of
                                                        incidence of liver
                                                        abscesses.
(iii) 75 mg/head/day............  Lasalocid 25 to 30.  Heifers fed in        Feed continuously            054771
                                                        confinement for       to provide 250 to
                                                        slaughter (over 400   360 mg lasalocid
                                                        lb): For reduction    and 75 mg of
                                                        of incidence of       oxytetracycline
                                                        liver abscesses;      per head per day.
                                                        and for increased     Lasalocid as
                                                        rate of weight gain   provided by No.
                                                        and improved feed     054771 in Sec.
                                                        efficiency.           510.600(c) of this
                                                                              chapter.
(iv) 75 mg/head/day.............  Melengestrol         Heifers fed in        Feed continuously            054771
                                   acetate, 0.25 to     confinement for       to provide 0.25 to
                                   2.0.                 slaughter (over 400   0.5 mg of
                                                        lb): For reduction    melengestrol
                                                        of incidence of       acetate and 75 mg
                                                        liver abscesses;      of oxytetracycline
                                                        and for increased     per head per day.
                                                        rate of weight        Melengestrol as
                                                        gain, improved feed   provided by No.
                                                        efficiency, and       054771 in Sec.
                                                        suppression of        510.600(c) of this
                                                        estrus (heat).        chapter.
(v) 0.5 to 2.0 g/head/day.......  ...................  Cattle: For           Feed 3 to 5 days             066104
                                                        prevention and        before and after            069254
                                                        treatment of the      arrival in
                                                        early stages of       feedlots.
                                                        shipping fever
                                                        complex.
----------------------------------------------------------------------------------------------------------------

    (5) Minor species--

----------------------------------------------------------------------------------------------------------------
         Oxytetracycline amount              Indications for use              Limitations             Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 10 mg/lb of body weight daily......  Sheep: For treatment of      Feed continuously for 7 to          066104
                                          bacterial enteritis caused   14 days; withdraw 5 days           069254
                                          by E. coli and bacterial     before slaughter.
                                          pneumonia caused by P.
                                          multocida susceptible to
                                          oxytetracycline.
(ii) 200 mg/colony.....................  Honey bees: For control of   Remove at least 6 weeks             066104
                                          American foulbrood caused    prior to main honey flow.          069254
                                          by Paenibacillus larvae
                                          and European foulbrood
                                          caused by Streptococcus
                                          pluton susceptible to
                                          oxytetracycline.
(iii) 2.5 to 3.75 g/100 lb of fish/day.  1. Salmonids: For control    Administer in mixed ration          066104
                                          of ulcer disease caused by   for 10 days; do not
                                          Haemophilus piscium,         liberate fish or
                                          furunculosis caused by       slaughter fish for food
                                          Aeromonas salmonicida,       for 21 days following the
                                          bacterial hemorrhagic        last administration of
                                          septicemia caused by A.      medicated feed.
                                          hydrophila, and
                                          pseudomonas disease.
                                         2. Catfish: For control of   Administer in mixed ration          066104
                                          bacterial hemorrhagic        for 10 days; do not
                                          septicemia caused by A.      liberate fish or
                                          hydrophila and pseudomonas   slaughter fish for food
                                          disease.                     for 21 days following the
                                                                       last administration of
                                                                       medicated feed; do not
                                                                       administer when water
                                                                       temperature is below 16.7
                                                                       [deg]C (62 [deg]F).
(iv) 3.75 g/100 lb of fish/day.........  1. Freshwater-reared         Administer in mixed ration          066104
                                          salmonids: For control of    for 10 days. Do not
                                          mortality due to coldwater   liberate fish or
                                          disease associated with      slaughter fish for food
                                          Flavobacterium               for 21 days following the
                                          psychrophilum..              last administration of
                                                                       medicated feed.
                                         2. Freshwater-reared         Administer in mixed ration          066104
                                          Oncorhynchus mykiss: For     for 10 days. Do not
                                          control of mortality due     liberate fish or
                                          to columnaris disease        slaughter fish for food
                                          associated with              for 21 days following the
                                          Flavobacterium columnare..   last administration of
                                                                       medicated feed.
                                         3. Freshwater-reared         Feed for 10 days.                   066104
                                          salmonids weighing up to     Immediate release is
                                          55 grams: For marking the    permitted following last
                                          skeletal tissue..            feeding of medicated feed.

[[Page 501]]

 
(v) 11.35 g/100 lb of fish/day.........  Pacific salmon not over 30   Administer medicated feed           066104
                                          grams body weight: For       as the sole ration for 4
                                          marking of skeletal tissue.  consecutive days. Do not
                                                                       liberate for at least 7
                                                                       days following last
                                                                       feeding of medicated feed.
(vi) 1 g/lb of medicated feed..........  Lobsters: For control of     Administer as sole ration           066104
                                          gaffkemia caused by          for 5 consecutive days;
                                          Aerococcus viridans.         withdraw medicated feed
                                                                       30 days before harvesting
                                                                       lobsters.
----------------------------------------------------------------------------------------------------------------


[81 FR 95009, Dec. 27, 2016, as amended at 82 FR 11512, Feb. 24, 2017; 
83 FR 48948, Sept. 28, 2018; 84 FR 12502, Apr. 2, 2019; 86 FR 14825, 
Mar. 19, 2021]



Sec. 558.455  Oxytetracycline and neomycin.

    (a) Specifications. Type A medicated articles containing 
oxytetracycline equivalent to 50 grams per pound (g/lb) oxytetracycline 
hydrochloride and 50 g/lb neomycin sulfate or oxytetracycline equivalent 
to 100 g/lb oxytetracycline hydrochloride and 100 g/lb neomycin sulfate.
    (b) Sponsors. See Nos. 066104 and 069254 in Sec. 510.600(c) of this 
chapter.
    (c) Related tolerances. See Sec. Sec. 556.430 and 556.500 of this 
chapter.
    (d) Special considerations. (1) Federal law restricts medicated feed 
containing this veterinary feed directive (VFD) drug to use by or on the 
order of a licensed veterinarian. See Sec. 558.6 for additional 
requirements.
    (2) The expiration date of VFDs for oxytetracycline and neomycin 
medicated feeds must not exceed 6 months from the date of issuance. VFDs 
for oxytetracycline and neomycin shall not be refilled.
    (3) Cattle feeds shall bear the following warning statement: ``Use 
of more than one product containing neomycin or failure to follow 
withdrawal times may result in illegal drug residues.''
    (e) Indications for use--(1) Chickens. It is used in feed as 
follows:

----------------------------------------------------------------------------------------------------------------
   Oxytetracycline and neomycin sulfate
     amount in grams per ton of feed            Indications for use               Limitations           Sponsors
----------------------------------------------------------------------------------------------------------------
(i) [Reserved]...........................
----------------------------------------------------------------------------------------------------------------
(ii) 100 to 200..........................  Chickens: For control of      Feed continuously for 7 to       066104
                                            infectious synovitis caused   14 d; do not feed to            069254
                                            by Mycoplasma synoviae;       chickens producing eggs for
                                            control of fowl cholera       human consumption; in low
                                            caused by Pasteurella         calcium feed, withdraw 3 d
                                            multocida susceptible to      before slaughter..
                                            oxytetracycline..
----------------------------------------------------------------------------------------------------------------
(iii) 400................................  Chickens: For control of      Feed continuously for 7 to       066104
                                            chronic respiratory disease   14 d; do not feed to            069254
                                            (CRD) and air sac infection   chickens producing eggs for
                                            caused by M. gallisepticum    human consumption; in low
                                            and Escherichia coli          calcium feeds, withdraw 3 d
                                            susceptible to                before slaughter..
                                            oxytetracycline..
----------------------------------------------------------------------------------------------------------------
(iv) 500.................................  Chickens: For reduction of    Feed continuously for 5 d;       066104
                                            mortality due to air          do not feed to chickens         069254
                                            sacculitis (air-sac-          producing eggs for human
                                            infection) caused by E.       consumption; withdraw 24
                                            coli susceptible to           hours before slaughter; in
                                            oxytetracycline..             low calcium feeds withdraw
                                                                          3 d before slaughter..
----------------------------------------------------------------------------------------------------------------

    (2) Turkeys. It is used in feed as follows:

----------------------------------------------------------------------------------------------------------------
   Oxytetracycline and neomycin sulfate
                  amount                        Indications for use               Limitations           Sponsors
----------------------------------------------------------------------------------------------------------------
(i) [Reserved]...........................
----------------------------------------------------------------------------------------------------------------
(ii) 100 g/ton of feed...................  Turkeys: For control of       Feed continuously for 7 to       066104
                                            hexamitiasis caused by        14 d; do not feed to            069254
                                            Hexamita meleagridis          turkeys producing eggs for
                                            susceptible to                human consumption..
                                            oxytetracycline..
----------------------------------------------------------------------------------------------------------------
(iii) 200 g/ton of feed..................  Turkeys: For control of       Feed continuously for 7 to       066104
                                            infectious synovitis caused   14 d; withdraw 5 d before       069254
                                            by M. synoviae susceptible    slaughter; do not feed to
                                            to oxytetracycline..          turkeys producing eggs for
                                                                          human consumption..
----------------------------------------------------------------------------------------------------------------

[[Page 502]]

 
(iv) To provide 25 milligrams per pound    Turkeys: For control of       Feed continuously for 7 to       066104
 (mg/lb) of body weight daily..             complicating bacterial        14 d; withdraw 5 d before       069254
                                            organisms associated with     slaughter; do not feed to
                                            bluecomb (transmissible       turkeys producing eggs for
                                            enteritis; coronaviral        human consumption..
                                            enteritis) susceptible to
                                            oxytetracycline..
----------------------------------------------------------------------------------------------------------------

    (3) Swine. It is used in feed as follows:

----------------------------------------------------------------------------------------------------------------
   Oxytetracycline and neomycin sulfate
                  amount                        Indications for use               Limitations           Sponsors
----------------------------------------------------------------------------------------------------------------
(i) [Reserved]...........................
----------------------------------------------------------------------------------------------------------------
(ii) To provide 10 mg/lb of body weight    1. Swine: For treatment of    Feed continuously for 7 to       066104
 daily..                                    bacterial enteritis caused    14 d; withdraw 5 d before       069254
                                            by E. coli and Salmonella     slaughter..
                                            choleraesuis and treatment
                                            of bacterial pneumonia
                                            caused by P. multocida
                                            susceptible to
                                            oxytetracycline; treatment
                                            and control of
                                            colibacillosis (bacterial
                                            enteritis) caused by E.
                                            coli susceptible to
                                            neomycin..
                                           2. Breeding swine: For        Feed continuously for not        066104
                                            control and treatment of      more than 14 d; withdraw 5      069254
                                            leptospirosis (reducing the   d before slaughter..
                                            incidence of abortion and
                                            shedding of leptospirae)
                                            caused by Leptospira pomona
                                            susceptible to
                                            oxytetracycline..
----------------------------------------------------------------------------------------------------------------

    (4) Cattle and sheep. It is used in feed as follows:

----------------------------------------------------------------------------------------------------------------
   Oxytetracycline and neomycin sulfate
                  amount                        Indications for use               Limitations           Sponsors
----------------------------------------------------------------------------------------------------------------
(i)-(ii) [Reserved]......................
----------------------------------------------------------------------------------------------------------------
(iii) To provide 10 mg/lb of body weight   1. Calves and beef and        Feed continuously for 7 to       066104
 daily..                                    nonlactating dairy cattle:    14 d; in feed or milk           069254
                                            For treatment of bacterial    replacers. If symptoms
                                            enteritis caused by E. coli   persist after using for 2
                                            and bacterial pneumonia       or 3 days, consult a
                                            (shipping fever complex)      veterinarian. Treatment
                                            caused by P. multocida        should continue 24 to 48
                                            susceptible to                hours beyond remission of
                                            oxytetracycline; treatment    disease symptoms. A
                                            and control of                withdrawal period has not
                                            colibacillosis (bacterial     been established for use in
                                            enteritis) caused by E.       preruminating calves. Do
                                            coli susceptible to           not use in calves to be
                                            neomycin..                    processed for veal. A milk
                                                                          discard time has not been
                                                                          established for use in
                                                                          lactating dairy cattle. Do
                                                                          not use in female dairy
                                                                          cattle 20 months of age or
                                                                          older. Withdraw 5 d before
                                                                          slaughter..
                                           2. Calves (up to 250 lb):     Feed continuously for 7 to       066104
                                            For treatment of bacterial    14 d; in milk replacers or      069254
                                            enteritis caused by E. coli   starter feed. If symptoms
                                            susceptible to                persist after using for 2
                                            oxytetracycline; treatment    or 3 days, consult a
                                            and control of                veterinarian. Treatment
                                            colibacillosis (bacterial     should continue 24 to 48
                                            enteritis) caused by E.       hours beyond remission of
                                            coli susceptible to           disease symptoms. A
                                            neomycin..                    withdrawal period has not
                                                                          been established for use in
                                                                          preruminating calves. Do
                                                                          not use in calves to be
                                                                          processed for veal. A milk
                                                                          discard time has not been
                                                                          established for use in
                                                                          lactating dairy cattle. Do
                                                                          not use in female dairy
                                                                          cattle 20 months of age or
                                                                          older. Withdraw 5 d before
                                                                          slaughter..
                                           3. Sheep: For treatment of    Feed continuously for 7 to       066104
                                            bacterial enteritis caused    14 d. If symptoms persist       069254
                                            by E. coli and bacterial      after using for 2 or 3
                                            pneumonia caused by P.        days, consult a
                                            multocida susceptible to      veterinarian. Treatment
                                            oxytetracycline; treatment    should continue 24 to 48
                                            and control of                hours beyond remission of
                                            colibacillosis (bacterial     disease symptoms. Withdraw
                                            enteritis) caused by E.       5 d before slaughter..
                                            coli susceptible to
                                            neomycin..
----------------------------------------------------------------------------------------------------------------
(iv) [Reserved]..........................
----------------------------------------------------------------------------------------------------------------

[[Page 503]]

 
(v) To provide 75 mg/head/day............  Growing cattle (over 400      Feed continuously...........     066104
                                            lb): For reduction of liver                                   069254
                                            condemnation due to liver
                                            abscesses..
----------------------------------------------------------------------------------------------------------------
(vi) To provide 0.5 to 2.0 g/head/ day...  Cattle: For prevention and    Feed 3 to 5 d before and         066104
                                            treatment of the early        after arrival in feedlots.      069254
                                            stages of shipping fever      A withdrawal period has not
                                            complex..                     been established for use in
                                                                          preruminating calves. Do
                                                                          not use in calves to be
                                                                          processed for veal. A milk
                                                                          discard time has not been
                                                                          established for use in
                                                                          lactating dairy cattle. Do
                                                                          not use in female dairy
                                                                          cattle 20 months of age or
                                                                          older..
----------------------------------------------------------------------------------------------------------------


[71 FR 16225, Mar. 31, 2006, as amended at 74 FR 40724, Aug. 13, 2009; 
80 FR 13232, Mar. 13, 2015; 81 FR 95012, Dec. 27, 2016]



Sec. 558.464  Poloxalene.

    (a) Specifications. Dry Type A medicated articles containing 53 
percent poloxalene or liquid Type A medicated articles containing 99.5 
percent poloxalene.
    (b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
    (c) Related tolerances. See Sec. 556.517 of this chapter.
    (d) Conditions of use. (1) For prevention of legume (alfalfa, 
clover) and wheat pasture bloat in cattle.
    (2) Poloxalene dry Type A article and liquid Type A article must be 
thoroughly blended and evenly distributed in feed prior to use. This may 
be accomplished by adding the Type A article to a small quantity of 
feed, mixing thoroughly, then adding this mixture to the remaining feed 
and again mixing thoroughly. Dosage is 1 gram of poloxalene per 100 
pounds of body weight daily and continued during exposure to bloat 
producing conditions. If bloating conditions are severe, the dose is 
doubled. Treatment should be started 2 to 3 days before exposure to 
bloat-producing conditions. Repeat dosage if animals are exposed to 
bloat-producing conditions more than 12 hours after the last treatment. 
Do not exceed the higher dosage levels in any 24-hour period.

[40 FR 39857, Aug. 29, 1975, as amended at 51 FR 7399, Mar. 3, 1986; 52 
FR 2686, Jan. 26, 1987; 56 FR 50654, Oct. 8, 1991; 60 FR 55660, Nov. 2, 
1995; 79 FR 13545, Mar. 11, 2014; 84 FR 33001, July 11, 2019]



Sec. 558.470  Polyoxyethylene.

    (a) Specifications. Each molasses-based block contains 2.2 percent 
polyoxyethylene (23) lauryl ether.
    (b) Sponsor. See No. 067949 in Sec. 510.600(c) of this chapter.
    (c) [Reserved]
    (d) Conditions of use--(1) Amount. 2 grams of polyoxyethylene (23) 
lauryl ether per 100 kilograms of body weight per day (1 pound of block 
per 500 kilogram (1,100 pound) animal per day). Initially, provide one 
block per five head of cattle. Start treatment 10 to 14 days before 
exposure to bloat-producing pastures.
    (2) Indications for use. For reduction of the incidence of bloat 
(alfalfa and clover) in pastured cattle.
    (3) Limitations. Administer free-choice to beef cattle and 
nonlactating dairy cattle only. Do not allow cattle access to other 
sources of salt while being fed this product. Do not feed this product 
to animals without adequate forage/roughage consumption.

[86 FR 14826, Mar. 19, 2021]



Sec. 558.485  Pyrantel.

    (a) Specifications. Type A medicated articles containing 48 or 80 
grams per pound pyrantel tartrate.
    (b) Sponsors. See sponsors in Sec. 510.600(c) of this chapter for 
use as follows:
    (1) No. 066104: 48 and 80 grams per pound for use as in paragraph 
(e)(1) of this section.
    (2) Nos. 017135 and 054771: 48 grams per pound for use as in 
paragraph (e)(2) of this section.

[[Page 504]]

    (c) Related tolerances. See Sec. 556.560 of this chapter.
    (d) Special considerations. (1) See Sec. 500.25 of this chapter. 
Consult a veterinarian before using in severely debilitated animals.
    (2) Do not mix in Type B or Type C medicated feeds containing 
bentonite.
    (e) Conditions of use--(1) Swine--

----------------------------------------------------------------------------------------------------------------
         Pyrantel  grams/ton              Indications for use                 Limitations              Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 96..............................  Swine: As an aid in the      Feed continuously as the sole          066104
                                       prevention of migration      ration in a Type C feed.
                                       and establishment of large   Withdraw 24 hours prior to
                                       roundworm (Ascaris suum)     slaughter.
                                       infections; aid in the
                                       prevention of
                                       establishment of nodular
                                       worm (Oesophagostomum)
                                       infections.
(ii) 96.............................  Swine: For the removal and   Feed for 3 days as the sole            066104
                                       control of large roundworm   ration in a Type C feed.
                                       (Ascaris suum) infections.   Withdraw 24 hours prior to
                                                                    slaughter.
(iii) 800...........................  Swine: For the removal and   Feed as the sole ration for a          066104
                                       control of large roundworm   single therapeutic treatment in
                                       (Ascaris suum) and nodular   Type C feed at a rate of 1 lb
                                       worm (Oesophagostomum)       of feed per 40 lb of body
                                       infections.                  weight for animals up to 200
                                                                    lb, and 5 lb of feed per head
                                                                    for animals 200 lb or over.
                                                                    Withdraw 24 hours prior to
                                                                    slaughter.
----------------------------------------------------------------------------------------------------------------

    (2) Horses--

----------------------------------------------------------------------------------------------------------------
         Pyrantel  grams/ton              Indications for use                 Limitations              Sponsor
----------------------------------------------------------------------------------------------------------------
To provide 1.2 mg/lb body weight....  Prevention of Strongylus     Feed continuously. Administer          017135
                                       vulgaris larval              either as a top-dress (not to         054771
                                       infections; control of       exceed 20,000 g/ton) or mixed
                                       adult large strongyles (S.   in the horse's daily grain
                                       vulgaris, and S.             ration (not to exceed 1,200 g/
                                       edentatus), adult and 4th    ton) during the time that the
                                       stage larvae small           animal is at risk of exposure
                                       strongyles (Cyathostomum     to internal parasites. Do not
                                       spp., Cylicocyclus spp.,     use in horses intended for
                                       Cylicostephanus spp.,        human consumption. Consult your
                                       Cylicodontophorus spp.,      veterinarian before using in
                                       Poteriostomum spp., and      severely debilitated animals
                                       Triodontophorus spp.),       and for assistance in the
                                       adult and 4th stage larvae   diagnosis, treatment, and
                                       pinworms (Oxyuris equi),     control of parasitism.
                                       and adult and 4th stage
                                       larvae ascarids
                                       (Parascaris equorum).
----------------------------------------------------------------------------------------------------------------

    (3) Pyrantel may also be used in combination with:
    (i) Carbadox as in Sec. 558.115.
    (ii) Lincomycin as in Sec. 558.325.
    (iii) Tylosin as in Sec. 558.625.

[83 FR 48948, Sept. 28, 2018, as amended at 83 FR 64744, Dec. 18, 2018; 
86 FR 14826, Mar. 19, 2021]



Sec. 558.500  Ractopamine.

    (a) Specifications. Type A medicated articles containing 9 or 45.4 
grams of ractopamine hydrochloride per pound.
    (b) Sponsor. See Nos. 054771 and 058198 in Sec. 510.600(c) of this 
chapter.
    (c) Related tolerances. See Sec. 556.570 of this chapter.

[[Page 505]]

    (d) Special considerations. (1) Labeling of Type B and Type C feeds 
shall bear the following: ``Not for animals intended for breeding.''
    (2) Labeling of Type B and Type C swine feeds shall bear the 
following:
    (i) ``No increased benefit has been shown when ractopamine 
concentrations in the diet are greater than 4.5 g/ton.''
    (ii) ``Ractopamine may increase the number of injured and/or 
fatigued pigs during marketing.''
    (3) Labeling of Type B and Type C tom turkey feeds shall bear the 
following: ``No increased benefit has been shown when ractopamine 
concentrations in the diet are greater than 4.6 g/ton.''
    (4) Tylosin in combinations as tylosin phosphate.
    (5) Ractopamine liquid Type B cattle feeds may be manufactured from 
dry ractopamine Type A articles. The liquid Type B feeds must be 
maintained at a pH of 4.5 to 7.5 or, if in combination with monensin 
and/or tylosin, at a pH of 4.5 to 6.0. Mixing directions for liquid Type 
B feeds requiring recirculation or agitation: Recirculate immediately 
prior to use for not less than 10 minutes, moving not less than 1 
percent of the tank contents per minute from the bottom of the tank to 
the top. Recirculate daily as described even when not used.
    (e) Conditions of use--(1) Swine--

----------------------------------------------------------------------------------------------------------------
                                   Combination in grams/
     Ractopamine in grams/ton               ton            Indications for use        Limitations       Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 4.5 to 9.0...................  ....................  For increased rate of    Feed continuously      058198,
                                                          weight gain, improved    as sole ration.        054771
                                                          feed efficiency, and
                                                          increased carcass
                                                          leanness in finishing
                                                          swine, weighing not
                                                          less than 150 lbs, fed
                                                          a complete ration
                                                          containing at least
                                                          16% crude protein for
                                                          the last 45 to 90 lbs
                                                          of gain prior to
                                                          slaughter.
(ii) [Reserved]..................
----------------------------------------------------------------------------------------------------------------

    (2) Cattle.

----------------------------------------------------------------------------------------------------------------
                                     Combination in
    Ractopamine in  grams/ton          grams/ton        Indications for use       Limitations         Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 8.2 to 24.6.................  ...................  Cattle fed in          Feed continuously           016592
                                                        confinement for        as sole ration
                                                        slaughter: For         during the last
                                                        increased rate of      28 to 42 days on
                                                        weight gain and        feed.
                                                        improved feed
                                                        efficiency during
                                                        the last 28 to 42
                                                        days on feed.
(ii) 8.2 to 24.6................  Monensin 10 to 40    Cattle fed in          Feed continuously           016592
                                   to provide 0.14 to   confinement for        as sole ration             054771
                                   0.42 mg monensin/    slaughter: For         during the last            058198
                                   lb of body weight,   increased rate of      28 to 42 days on
                                   depending on         weight gain and        feed. See
                                   severity of          improved feed          paragraph Sec.
                                   coccidiosis          efficiency during      558.355(d).
                                   challenge, up to     the last 28 to 42      Ractopamine as
                                   480 mg/head/day..    days on feed, and      provided by No.
                                                        for prevention and     058198 or 054771;
                                                        control of             monensin as
                                                        coccidiosis due to     provided by No.
                                                        Eimeria bovis and E.   016592 or 058198
                                                        zuernii.               in Sec.
                                                                               510.600(c) of
                                                                               this chapter.
(iii) 9.8 to 24.6...............  ...................  Cattle fed in          Feed continuously           016592
                                                        confinement for        as sole ration             054771
                                                        slaughter: For         during the last            058198
                                                        increased rate of      28 to 42 days on
                                                        weight gain,           feed.
                                                        improved feed
                                                        efficiency, and
                                                        increased carcass
                                                        leanness during the
                                                        last 28 to 42 days
                                                        on feed.

[[Page 506]]

 
(iv) 9.8 to 24.6................  Monensin 10 to 40    Cattle fed in          Feed continuously           016592
                                   to provide 0.14 to   confinement for        as sole ration             054771
                                   0.42 mg monensin/    slaughter: For         during the last            058198
                                   lb of body weight,   increased rate of      28 to 42 days on
                                   depending on         weight gain,           feed. Not for
                                   severity of          improved feed          animals intended
                                   coccidiosis          efficiency, and        for breeding. See
                                   challenge, up to     increased carcass      paragraph Sec.
                                   480 mg/head/day.     leanness during the    558.355(d).
                                                        last 28 to 42 days     Ractopamine as
                                                        on feed, and for       provided by No.
                                                        prevention and         058198 or 054771;
                                                        control of             monensin as
                                                        coccidiosis due to     provided by No.
                                                        Eimeria bovis and E.   016592 or 058198
                                                        zuernii.               in Sec.
                                                                               510.600(c) of
                                                                               this chapter.
(v) 9.8 to 24.6.................  Monensin 10 to 40    Heifers fed in         Feed continuously           016592
                                   to provide 0.14 to   confinement for        as sole ration             054771
                                   0.42 mg monensin/    slaughter: For         during the last            058198
                                   lb of body weight,   increased rate of      28 to 42 days on
                                   depending on         weight gain,           feed. Not for
                                   severity of          improved feed          animals intended
                                   coccidiosis          efficiency, and        for breeding. See
                                   challenge, up to     increased carcass      Sec. Sec.
                                   480 mg/head/day,     leanness during the    558.342(d) and
                                   plus melengestrol    last 28 to 42 days     558.355(d).
                                   acetate to provide   on feed, and for       Melengestrol
                                   0.25 to 0.5 mg/      prevention and         acetate as
                                   head/day.            control of             provided by No.
                                                        coccidiosis due to     058198 or 054771;
                                                        Eimeria bovis and E.   monensin as
                                                        zuernii, and for       provided by No.
                                                        suppression of         016592 or 058198
                                                        estrus (heat).         in Sec.
                                                                               510.600(c) of
                                                                               this chapter.
(vi) Not to exceed 800; to        ...................  Cattle fed in          Top dress in a              016592
 provide 70 to 400 mg/head/day.                         confinement for        minimum of 1 lb            054771
                                                        slaughter: For         of medicated feed.         058198
                                                        increased rate of
                                                        weight gain and
                                                        improved feed
                                                        efficiency during
                                                        the last 28 to 42
                                                        days on feed.
(vii) Not to exceed 800; to       Monensin 10 to 40    Cattle fed in          Top dress                   016592
 provide 70 to 400 mg/head/day.    to provide 0.14 to   confinement for        ractopamine in a           054771
                                   0.42 mg monensin/    slaughter: For         minimum of 1 lb            058198
                                   lb of body weight,   increased rate of      of medicated feed
                                   depending on         weight gain and        during the last
                                   severity of          improved feed          28 to 42 days on
                                   coccidiosis          efficiency during      feed. Not for
                                   challenge, up to     the last 28 to 42      animals intended
                                   480 mg/head/day.     days on feed, and      for breeding. See
                                                        for prevention and     Sec.
                                                        control of             558.355(d).
                                                        coccidiosis due to     Ractopamine as
                                                        Eimeria bovis and E.   provided by No.
                                                        zuernii.               058198 or 054771;
                                                                               monensin as
                                                                               provided by No.
                                                                               016592 or 058198
                                                                               in Sec.
                                                                               510.600(c) of
                                                                               this chapter.
----------------------------------------------------------------------------------------------------------------

    (3) Turkeys--

----------------------------------------------------------------------------------------------------------------
                                   Combination in grams/
     Ractopamine in grams/ton               ton            Indications for use        Limitations       Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 4.6 to 11.8 (5 to 13 ppm)....  ....................  Finishing hen turkeys:   Feed continuously       058198
                                                          For increased rate of    as sole ration
                                                          weight gain and          during the last 7
                                                          improved feed            to 14 days prior
                                                          efficiency when fed      to slaughter..
                                                          for the last 7 to 14
                                                          days prior to
                                                          slaughter..
(ii) 4.6 to 11.8 (5 to 13 ppm)...  ....................  Finishing tom turkeys:   Feed continuously       058198
                                                          For increased rate of    as sole ration
                                                          weight gain and          during the last 14
                                                          improved feed            days prior to
                                                          efficiency when fed      slaughter. Feeding
                                                          for the last 14 days     ractopamine to tom
                                                          prior to slaughter..     turkeys during
                                                                                   periods of
                                                                                   excessive heat can
                                                                                   result in
                                                                                   increased
                                                                                   mortality..
(iii) 4.6 to 11.8 (5 to 13 ppm)..  Monensin 54 to 90...  Finishing hen turkeys:   Feed continuously       058198
                                                          As in paragraph          as sole ration
                                                          (e)(3)(i) of this        during the last 7
                                                          section; and for the     to 14 days prior
                                                          prevention of            to slaughter. See
                                                          coccidiosis in growing   Sec. 558.355(d)..
                                                          turkeys caused by
                                                          Eimeria adenoeides, E.
                                                          meleagrimitis and E.
                                                          gallopavonis..

[[Page 507]]

 
(iv) 4.6 to 11.8 (5 to 13 ppm)...  Monensin 54 to 90...  Finishing tom turkeys:   Feed continuously       058198
                                                          As in paragraph          as sole ration
                                                          (e)(3)(ii) of this       during the last 14
                                                          section; and for the     days prior to
                                                          prevention of            slaughter. Feeding
                                                          coccidiosis in growing   ractopamine to tom
                                                          turkeys caused by        turkeys during
                                                          Eimeria adenoeides, E.   periods of
                                                          meleagrimitis and E.     excessive heat can
                                                          gallopavonis..           result in
                                                                                   increased
                                                                                   mortality. See
                                                                                   Sec. 558.355(d)..
----------------------------------------------------------------------------------------------------------------

    (4) Ractopamine may also be used in combination with tylosin in as 
in Sec. 558.625.

[67 FR 71820, Dec. 3, 2002, as amended at 68 FR 54659, Sept. 18, 2003; 
69 FR 12068, Mar. 15, 2004; 69 FR 51174, Aug. 18, 2004; 71 FR 31074, 
June 1, 2006; 71 FR 67301, Nov. 21, 2006; 72 FR 10358, Mar. 8, 2007; 72 
FR 41619, July 31, 2007; 72 FR 56897, Oct. 5, 2007; 72 FR 62571, Nov. 6, 
2007; 72 FR 65667, Nov. 23, 2007; 72 FR 70777, Dec. 13, 2007; 73 FR 
72715, Dec. 1, 2008; 73 FR 75323, Dec. 11, 2008; 74 FR 66914, Dec. 17, 
2009; 75 FR 1276, Jan. 11, 2010; 75 FR 5888, Feb. 5, 2010; 75 FR 20917, 
Apr. 22, 2010; 75 FR 54018, Sept. 3, 2010; 77 FR 31724, May 30, 2012; 78 
FR 63872, Oct. 25, 2013; 79 FR 13546, Mar. 11, 2014; 79 FR 37621, July 
2, 2014; 79 FR 44278, July 31, 2014; 79 FR 53136, Sept. 8, 2014; 80 FR 
61298, Oct. 13, 2015; 81 FR 48703, July 26, 2016; 81 FR 95013, Dec. 27, 
2016; 85 FR 18122, Apr. 1, 2020; 85 FR 45311, July 28, 2020; 86 FR 
13190, Mar. 8, 2021; 86 FR 14826, Mar. 19, 2021]



Sec. 558.515  Robenidine.

    (a) Specifications. Type A medicated articles containing 30 grams 
per pound.
    (b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
    (c) Related tolerances. See Sec. 556.580 of this chapter.
    (d) Special considerations. Type C feed containing robenidine 
hydrochloride must be fed within 50 days from the date of manufacture. 
Do not use in Type B or Type C medicated feeds containing bentonite.
    (e) Conditions of use. It is used in feed for chickens as follows:

----------------------------------------------------------------------------------------------------------------
Robenidine hydrochloride in grams/ Combination in grams/
               ton                          ton            Indications for use        Limitations       Sponsor
----------------------------------------------------------------------------------------------------------------
30 (0.0033 pct)..................  ....................  Broiler chickens: As an  Feed continuously       054771
                                                          aid in the prevention    as sole ration. Do
                                                          of coccidiosis caused    not feed to
                                                          by E. mivati, E.         chickens producing
                                                          brunetti, E. tenella,    eggs for food.
                                                          E. acervulina, E.        Withdraw 5 days
                                                          maxima, and E.           prior to
                                                          necatrix..               slaughter..
                                   Bacitracin (as        For broiler and fryer    Feed continuously       054771
                                    bacitracin            chickens: As an aid in   as sole ration. Do
                                    methylenedisalicyla   the prevention of        not feed to laying
                                    te) 4 to 30.          coccidiosis caused by    chickens. Withdraw
                                                          E. mivati, E.            5 days prior to
                                                          brunetti, E. tenella,    slaughter..
                                                          E. acervulina, E.
                                                          maxima, and E.
                                                          necatrix. For
                                                          increased rate of
                                                          weight gain..
                                   Bacitracin (as        For broiler and fryer    Feed continuously       054771
                                    bacitracin            chickens: As an aid in   as sole ration. Do
                                    methylenedisalicyla   the prevention of        not feed to laying
                                    te) 27 to 50.         coccidiosis caused by    chickens. Withdraw
                                                          E. mivati, E.            5 days prior to
                                                          brunetti, E. tenella,    slaughter..
                                                          E. acervulina, E.
                                                          maxima, and E.
                                                          necatrix. For improved
                                                          feed efficiency..
                                   Bacitracin (as        For broiler and fryer    Feed continuously       054771
                                    bacitracin            chickens: As an aid in   as sole ration. Do
                                    methylenedisalicyla   the prevention of        not feed to laying
                                    te) 50.               necrotic enteritis       hens. Withdraw 5
                                                          caused or complicated    days before
                                                          by Clostridium spp. or   slaughter..
                                                          other organisms
                                                          susceptible to
                                                          bacitracin..

[[Page 508]]

 
                                   Bacitracin (as        For broiler and fryer    To control a            054771
                                    bacitracin            chickens: As an aid in   necrotic enteritis
                                    methylenedisalicyla   the control of           outbreak, start
                                    te) 100 to 200.       necrotic enteritis       medication at
                                                          caused or complicated    first clinical
                                                          by Clostridium spp. or   signs of disease;
                                                          other organisms          administer
                                                          susceptible to           continuously for 5
                                                          bacitracin..             to 7 days or as
                                                                                   long as clinical
                                                                                   signs persist,
                                                                                   then reduce
                                                                                   bacitracin
                                                                                   methylenedisalicyl
                                                                                   ate to prevention
                                                                                   level (50 g/ton).
                                                                                   Do not feed to
                                                                                   laying hens.
                                                                                   Withdraw 5 days
                                                                                   before slaughter..
                                   Bacitracin (as        For broiler and fryer    Feed continuously       054771
                                    bacitracin zinc) 4    chickens: As an aid in   as sole ration. Do     054771
                                    to 30.                the prevention of        not feed to laying
                                                          coccidiosis caused by    chickens. Withdraw
                                                          E. mivati, E.            5 days prior to
                                                          brunetti, E. tenella,    slaughter..
                                                          E. acervulina, E.
                                                          maxima, and E.
                                                          necatrix. For
                                                          increased rate of
                                                          weight gain..
                                   Bacitracin (as        For broiler and fryer    Feed continuously       054771
                                    bacitracin zinc) 27   chickens: As an aid in   as sole ration. Do     054771
                                    to 50.                the prevention of        not feed to laying
                                                          coccidiosis caused by    chickens. Withdraw
                                                          E. mivati, E.            5 days prior to
                                                          brunetti, E. tenella,    slaughter..
                                                          E. acervulina, E.
                                                          maxima, and E.
                                                          necatrix. For improved
                                                          feed efficiency..
----------------------------------------------------------------------------------------------------------------

    (f) Robenidine may also be used in combination with:
    (1) Chlortetracycline as in Sec. 558.128.
    (2) Lincomycin as in Sec. 558.325.
    (3) Oxytetracycline as in Sec. 558.450.

[40 FR 13959, Mar. 27, 1975]

    Editorial Note: For Federal Register citations affecting Sec. 
558.515, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and at www.govinfo.gov.



Sec. 558.550  Salinomycin.

    (a) Specifications. Type A medicated articles containing:
    (1) 30 grams of salinomycin sodium activity per pound; or
    (2) 60 grams of salinomycin sodium activity per pound.
    (b) Sponsors. See sponsors in Sec. 510.600(c) of this chapter as 
follows:
    (1) No. 016592 for product described in paragraph (a)(1) of this 
section.
    (2) Nos. 016592 and 069254 for product described in paragraph (a)(2) 
of this section.
    (c) Related tolerances. See Sec. 556.592 of this chapter.
    (d) Special considerations. Not approved for use with pellet 
binders.
    (e) Conditions of use. It is used as follows:
    (1) Chickens--

----------------------------------------------------------------------------------------------------------------
                                   Combination in grams/
     Salinomycin in grams/ton               ton            Indications for use        Limitations       Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 40 to 60.....................  ....................  Broiler, roaster, and    Feed continuously       016592
                                                          replacement (breeder     as sole ration. Do     069254
                                                          and layer) chickens:     not feed to birds
                                                          For the prevention of    producing eggs for
                                                          coccidiosis caused by    human consumption.
                                                          Eimeria tenella, E.      May be fatal if
                                                          necatrix, E.             accidentally fed
                                                          acervulina, E. maxima,   to adult turkeys
                                                          E. brunetti, and E.      or horses.
                                                          mivati.
(ii) 40 to 60....................  Bacitracin            Broiler, roaster, and    Feed continuously       016592
                                    methylenedisalicyla   replacement (breeder     as sole ration. Do     054771
                                    te, 4 to 50.          and layer) chickens:     not feed to laying
                                                          For the prevention of    chickens. May be
                                                          coccidiosis caused by    fatal if fed to
                                                          Eimeria tenella, E.      adult turkeys or
                                                          necatrix, E.             horses.
                                                          acervulina, E. maxima,   Salinomycin as
                                                          E. brunetti, and E.      provided by No.
                                                          mivati, and for          016592; bacitracin
                                                          increased rate of        methylenedisalicyl
                                                          weight gain and          ate as provided by
                                                          improved feed            No. 054771 in Sec.
                                                          efficiency.                510.600(c) of
                                                                                   this chapter.

[[Page 509]]

 
(iii) 40 to 60...................  Bacitracin            Broiler chickens: For    Feed continuously       054771
                                    methylenedisalicyla   the prevention of        as sole ration. Do
                                    te, 50.               coccidiosis caused by    not feed to laying
                                                          Eimeria tenella, E.      chickens. May be
                                                          necatrix, E.             fatal if fed to
                                                          acervulina, E. maxima,   adult turkeys or
                                                          E. brunetti, and E.      to horses.
                                                          mivati, and as an aid    Salinomycin as
                                                          in the prevention of     provided by No.
                                                          necrotic enteritis       016592; bacitracin
                                                          caused or complicated    methylenedisalicyl
                                                          by Clostridium spp. or   ate as provided by
                                                          other organisms          No. 054771 in Sec.
                                                          susceptible to             510.600(c) in
                                                          bacitracin.              this chapter.
(iv) 40 to 60....................  Bacitracin            Broiler chickens: For    Feed continuously       054771
                                    methylenedisalicyla   the prevention of        as sole ration. To
                                    te, 100 to 200.       coccidiosis caused by    control necrotic
                                                          Eimeria tenella, E.      enteritis, start
                                                          necatrix, E.             medication at
                                                          acervulina, E. maxima,   first clinical
                                                          E. brunetti, and E.      signs of disease;
                                                          mivati, and as an aid    vary dosage based
                                                          in the control of        on the severity of
                                                          necrotic enteritis       infection;
                                                          caused or complicated    administer
                                                          by Clostridium spp. or   continuously for 5
                                                          other organisms          to 7 days or as
                                                          susceptible to           long as clinical
                                                          bacitracin.              signs persist,
                                                                                   then reduce
                                                                                   bacitracin to
                                                                                   prevention level
                                                                                   (50 grams per
                                                                                   ton). Do not feed
                                                                                   to laying
                                                                                   chickens. May be
                                                                                   fatal if fed to
                                                                                   adult turkeys or
                                                                                   to horses.
                                                                                   Salinomycin as
                                                                                   provided by No.
                                                                                   016592; bacitracin
                                                                                   methylenedisalicyl
                                                                                   ate as provided by
                                                                                   No. 054771 in Sec.
                                                                                     510.600(c) in
                                                                                   this chapter.
(v) 40 to 60.....................  Bacitracin zinc, 10   Broiler chickens: For    Feed continuously       016592
                                    to 50.                the prevention of        as sole ration.        054771
                                                          coccidiosis caused by    Not approved for
                                                          Eimeria tenella, E.      use with pellet
                                                          necatrix, E.             binders. Do not
                                                          acervulina, E. maxima,   feed to layers.
                                                          E. brunetti, and E.      May be fatal if
                                                          mivati, and for          accidentally fed
                                                          increased rate of        to adult turkeys
                                                          weight gain.             or horses.
                                                                                   Bacitracin zinc as
                                                                                   provided by No.
                                                                                   054771 in Sec.
                                                                                   510.600(c) of this
                                                                                   chapter.
(vi) 40 to 60....................  Bambermycins, 1 to 3  Broiler chickens: For    Feed continuously       016592
                                                          the prevention of        as sole ration. Do
                                                          coccidiosis caused by    not feed to laying
                                                          Eimeria tenella, E.      chickens. Not
                                                          necatrix, E.             approved for use
                                                          acervulina, E. maxima,   with pellet
                                                          E. brunetti, and E.      binders. May be
                                                          mivati, and for          fatal if
                                                          improved feed            accidentally fed
                                                          efficiency.              to adult turkeys
                                                                                   or horses.
                                                                                   Salinomycin and
                                                                                   bambermycins as
                                                                                   provided by No.
                                                                                   016592 in Sec.
                                                                                   510.600(c) in this
                                                                                   chapter.
----------------------------------------------------------------------------------------------------------------

    (2) Game birds--

----------------------------------------------------------------------------------------------------------------
                                   Combination in grams
     Salinomycin in grams/ton             per ton          Indications for use        Limitations       Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 50...........................  ....................  Quail: For the           Feed continuously       016592
                                                          prevention of            as sole ration. Do     069254
                                                          coccidiosis caused by    not feed to birds
                                                          Eimeria. dispersa and    producing eggs for
                                                          E. lettyae.              human consumption.
                                                                                   May be fatal if
                                                                                   accidentally fed
                                                                                   to adult turkeys
                                                                                   or horses.
(ii) [Reserved]..................  ....................  .......................  ...................  .........
----------------------------------------------------------------------------------------------------------------

    (3) Combinations. Salinomycin may also be used in combination with:
    (i) Avilamycin as in Sec. 558.68.
    (ii) Chlortetracycline as in Sec. 558.128.
    (iii) Lincomycin as in Sec. 558.325.
    (iv) Oxytetracycline as in Sec. 558.450.
    (v) Virginiamycin as in Sec. 558.635.

[48 FR 30616, July 5, 1983]

    Editorial Note: For Federal Register citations affecting Sec. 
558.550, see the List of CFR Sections Affected, which appears in the

[[Page 510]]

Finding Aids section of the printed volume and at www.govinfo.gov.



Sec. 558.555  Semduramicin.

    (a) Specifications. Type A medicated article containing:
    (1) 22.7 grams (g) per pound (lb) (50 g/kilogram (kg)) semduramicin 
(as semduramicin sodium).
    (2) 22.7 g/lb (50 g/kg) semduramicin (as semduramicin sodium 
biomass).
    (b) Sponsor. See No. 066104 in Sec. 510.600(c) of this chapter for 
use of product described in paragraph (a)(1) of this section as in 
paragraph (d) of this section; for use of product described in paragraph 
(a)(2) of this section as in paragraph (e) of this section.
    (c) Related tolerances. See Sec. 556.597 of this chapter.
    (d) Conditions of use in chickens. It is used in chicken feed as 
follows:

------------------------------------------------------------------------
 Semduramicin    Combinations
 in grams per    in grams per   Indications    Limitations     Sponsor
      ton            ton          for use
------------------------------------------------------------------------
(1) 22.7 (25    .............  Broiler       Do not feed to       066104
 ppm)                           chickens:     laying hens.
                                For the
                                prevention
                                of
                                coccidiosis
                                caused by
                                Eimeria
                                acervulina,
                                E.
                                brunetti,
                                E. maxima,
                                E. mivati/
                                E. mitis,
                                E.
                                necatrix,
                                and E.
                                tenella.
------------------------------------------------------------------------
(2) 22.7        Bacitracin     Broiler       Feed                 066104
                 methylenedis   chickens:     continuously
                 alicylate 10   As in         as sole
                 to 50          paragraph     ration. Do
                                (d)(1) of     not feed to
                                this          laying hens.
                                section;      Bacitracin
                                for           methylenedisa
                                improved      licylate as
                                feed          provided by
                                efficiency.   No. 054771 in
                                              Sec.
                                              510.600(c) of
                                              this chapter.
------------------------------------------------------------------------
------------------------------------------------------------------------

    (e) Conditions of use in chickens. It is used in chicken feed as 
follows:

------------------------------------------------------------------------
 Semduramicin    Combination
 in grams per    in grams per   Indications    Limitations     Sponsor
      ton            ton          for use
------------------------------------------------------------------------
(1) 22.7 (25    .............  Broiler       Do not feed to       066104
 ppm)                           chickens:     laying hens.
                                For the
                                prevention
                                of
                                coccidiosis
                                caused by
                                Eimeria
                                tenella, E.
                                acervulina,
                                E. maxima,
                                E.
                                brunetti,
                                E.
                                necatrix,
                                and E.
                                mitis.
(2) [Reserved]
------------------------------------------------------------------------

    (f) Semduramycin may also be used in combination with virginiamycin 
as in Sec. 558.635.

[59 FR 17477, Apr. 13, 1994, as amended at 60 FR 57928, Nov. 24, 1995; 
61 FR 29481, June 11, 1996; 61 FR 43451, Aug. 23, 1996; 61 FR 66584, 
Dec. 18, 1996; 62 FR 66985, Dec. 23, 1997; 64 FR 48296, Sept. 3, 1999; 
66 FR 47964, Sept. 17, 2001; 69 FR 13221, Mar. 22, 2004; 70 FR 41961, 
July 21, 2005; 73 FR 812, Jan. 4, 2008; 74 FR 41631, Aug. 18, 2009; 79 
FR 10983, Feb. 27, 2014; 79 FR 13546, Mar. 11, 2014; 81 FR 17609, Mar. 
30, 2016; 81 FR 95013, Dec. 27, 2016; 86 FR 14826, Mar. 19, 2021]



Sec. 558.575  Sulfadimethoxine and ormetoprim.

    (a) Specifications. Type A medicated articles containing either:
    (1) 25 percent sulfadimethoxine and 15 percent ormetoprim; or
    (2) 25 percent sulfadimethoxine and 5 percent ormetoprim.
    (b) Sponsors. See sponsors in Sec. 510.600(c) of this chapter as 
follows:
    (1) No. 054771 for use of the product described in paragraph (a)(1) 
as in paragraphs (e)(1), (e)(2)(i), and (e)(3)(i) through (iii) of this 
section.
    (2) No. 015331 for use of the product described in paragraph (a)(2) 
as in paragraphs (e)(3)(iv) and (v) of this section.
    (c) Related tolerances. See Sec. Sec. 556.490 and 556.640 of this 
chapter.
    (d) Special considerations. (1) Federal law restricts medicated feed 
containing this veterinary feed directive (VFD) drug to use by or on the 
order of a licensed veterinarian. See Sec. 558.6 for additional 
requirements.
    (2) The expiration date of VFDs for sulfadimethoxine and ormetoprim

[[Page 511]]

medicated feeds must not exceed 6 months from the date of issuance. VFDs 
for sulfadimethoxine and ormetoprim shall not be refilled.
    (e) Conditions of use. It is used in animal feeds as follows:
    (1) Chickens--

----------------------------------------------------------------------------------------------------------------
  Sulfadimethoxine  and
  ormetoprim  grams/ton            Indications for use                      Limitations                Sponsors
----------------------------------------------------------------------------------------------------------------
(i) Sulfadimethoxine,      Broiler chickens: As an aid in the   Feed as sole ration. Withdraw 5           054771
 113.5; ormetoprim, 68.1.   prevention of coccidiosis caused     days before slaughter.
                            by all Eimeria species known to be
                            pathogenic to chickens, namely, E.
                            tenella, E. necatrix, E.
                            acervulina, E. brunetti, E.
                            mivati, and E. maxima, and
                            bacterial infections due to
                            Heterakis gallinarum (infectious
                            coryza), Escherichia coli
                            (colibacillosis) and Pasteurella
                            multocida (fowl cholera).
(ii) Sulfadimethoxine,     Replacement chickens: As an aid in   Feed as sole ration. Do not feed to       054771
 113.5; ormetoprim, 68.1.   the prevention of coccidiosis        chickens over 16 weeks (112 days)
                            caused by all Eimeria species        of age. Withdraw 5 days before
                            known to be pathogenic to            slaughter.
                            chickens, namely, E. tenella, E.
                            necatrix, E. acervulina, E.
                            brunetti, E. mivati, and E.
                            maxima, and bacterial infections
                            due to Heterakis gallinarum
                            (infectious coryza), Escherichia
                            coli (colibacillosis) and
                            Pasteurella multocida (fowl
                            cholera).
----------------------------------------------------------------------------------------------------------------

    (2) Turkeys--

----------------------------------------------------------------------------------------------------------------
  Sulfadimethoxine  and
  ormetoprim  grams/ton            Indications for use                      Limitations                Sponsors
----------------------------------------------------------------------------------------------------------------
(i) Sulfadimethoxine,      Turkeys: As an aid in the            Do not feed to turkeys producing          054771
 56.75; ormetoprim,         prevention of coccidiosis caused     eggs for food. Withdraw 5 days
 34.05.                     by all Eimeria species known to be   before slaughter.
                            pathogenic to turkeys, namely, E.
                            adenoeides, E. gallopavonis, and
                            E. meleagrimitis and bacterial
                            infection due to Pasteurella
                            multocida (fowl cholera).
(ii) [Reserved]
----------------------------------------------------------------------------------------------------------------

    (3) Minor species--

----------------------------------------------------------------------------------------------------------------
  Sulfadimethoxine  and
    ormetoprim amount              Indications for use                      Limitations                Sponsors
----------------------------------------------------------------------------------------------------------------
(i) Sulfadimethoxine,      Ducks, including breeding ducks: As  Feed as sole ration for 7 days.           054771
 227; ormetoprim, 136.2     an aid in the control of bacterial   Medication should be started at
 grams/ton of feed.         infections due to Pasteurella        the first signs of infection. Do
                            multocida (fowl cholera).            not feed to ducks producing eggs
                                                                 for food. Withdraw 5 days before
                                                                 slaughter.
(ii) Sulfadimethoxine,     Ducks: As an aid in the control of   Feed as a sole ration for 7 days.
 454; ormetoprim, 272.4     bacterial infections due to          Medication should be started at
 grams/ton of feed.         Escherichia coli, Riemerella         the first signs of infection. Not
                            anatipestifer, and severe            for breeding ducks. Do not feed to
                            challenge of Pasteurella multocida   ducks producing eggs for food.
                            (fowl cholera).                      Withdraw 5 days before slaughter.
(iii) Sulfadimethoxine,    Chukar partridges: For prevention    Feed continuously to young birds up       054771
 113.5; ormetoprim, 68.1    of coccidiosis caused by Eimeria     to 8 weeks of age as sole ration.
 grams/ton of feed.         kofoidi and E. legionensis.
(iv) 50 milligrams (mg)    Salmonids: For the control of        Administer for 5 consecutive days.        015331
 of active ingredients      furunculosis in salmonids (trout     Withdraw 42 days before release as
 per kilogram of body       and salmon) caused by Aeromonas      stocker fish or slaughter.
 weight per day.            salmonicida strains susceptible to
                            sulfadimethoxine and ormetoprim
                            combination.

[[Page 512]]

 
(v) 50 mg of active        Catfish: For control of enteric      Administer for 5 consecutive days.        015331
 ingredients per kilogram   septicemia of catfish caused by      Withdraw 3 days before slaughter
 of body weight per day.    Edwardsiella ictaluri strains        or release as stocker fish.
                            susceptible to sulfadimethoxine
                            and ormetoprim combination.
----------------------------------------------------------------------------------------------------------------


[40 FR 13959, Mar. 27, 1975, as amended at 42 FR 13550, Mar. 11, 1977; 
49 FR 33442, Aug. 23, 1984; 49 FR 46371, Nov. 26, 1984; 51 FR 7400, Mar. 
3, 1986; 51 FR 18884, May 23, 1986; 52 FR 2686, Jan. 26, 1987; 54 FR 
1686, Jan. 17, 1989; 63 FR 27846, May 21, 1998; 64 FR 26672, May 17, 
1999; 64 FR 43910, Aug. 12, 1999; 66 FR 46707, Sept. 7, 2001; 70 FR 
52292, Sept. 2, 2005; 79 FR 10983, Feb. 27, 2014; 79 FR 13546, Mar. 11, 
2014; 81 FR 95013, Dec. 27, 2016; 83 FR 13637, Mar. 30, 2018; 84 FR 
12502, Apr. 2, 2019; 86 FR 14827, Mar. 19, 2021]



Sec. 558.582  Sulfamerazine.

    (a) Specifications. Type A medicated articles containing 99 percent 
sulfamerazine.
    (b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
    (c) Related tolerances. See Sec. 556.660 of this chapter.
    (d) Special considerations. (1) Federal law restricts medicated feed 
containing this veterinary feed directive (VFD) drug to use by or on the 
order of a licensed veterinarian. See Sec. 558.6 for additional 
requirements.
    (2) The expiration date of VFDs for sulfamerazine medicated feeds 
must not exceed 6 months from the date of issuance. VFDs for 
sulfamerazine shall not be refilled.
    (e) Conditions of use. It is used in fish feed for as follows:

----------------------------------------------------------------------------------------------------------------
                                     Combination in
     Sulfamerazine grams/ton           grams/ton        Indications for use      Limitations          Sponsor
----------------------------------------------------------------------------------------------------------------
(1) To deliver 10 grams of        ...................  Rainbow trout, brook  Formulate to                 054771
 sulfamerazine per 100 pounds of                        trout, and brown      deliver 10 grams
 fish per day.                                          trout: For control    of sulfamerazine
                                                        of furunculosis.      per 100 pounds of
                                                                              fish per day.
                                                                              Treat for not more
                                                                              than 14 days. Do
                                                                              not treat within 3
                                                                              weeks of marketing
                                                                              or stocking in
                                                                              stream open to
                                                                              fishing.
(2) [Reserved]..................
----------------------------------------------------------------------------------------------------------------


[81 FR 95013, Dec. 27, 2016]



Sec. 558.586  Sulfaquinoxaline.

    (a) Specifications. Type A medicated articles containing 40 percent 
sulfaquinoxaline.
    (b) Sponsor. See No. 016592 in Sec. 510.600(c) of this chapter.
    (c) Related tolerances. See Sec. 556.685 of this chapter.
    (d) Special considerations. (1) Federal law restricts medicated feed 
containing this veterinary feed directive (VFD) drug to use by or on the 
order of a licensed veterinarian. See Sec. 558.6 for additional 
requirements.
    (2) The expiration date of VFDs for sulfaquinoxaline medicated feeds 
must not exceed 6 months from the date of issuance. VFDs for 
sulfaquinoxaline shall not be refilled.
    (e) Conditions of use--(1) Chickens--

[[Page 513]]



----------------------------------------------------------------------------------------------------------------
                                     Combination in
  Sulfaquinoxaline in grams/ton        grams/ton        Indications for use      Limitations          Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 0.015 percent...............  ...................  As an aid in          Feed continuously            016592
                                                        preventing            from the time
                                                        outbreaks of          birds are placed
                                                        coccidiosis caused    on litter and
                                                        by Eimeria tenella,   continue past the
                                                        E. necatrix, E.       age when
                                                        acervulina, E.        coccidiosis is
                                                        maxima, and E.        ordinarily a
                                                        brunetti under        hazard. If death
                                                        average conditions    losses exceed 0.5
                                                        of exposure.          percent in a 2-day
                                                                              period, obtain a
                                                                              laboratory
                                                                              diagnosis. If
                                                                              coccidiosis is the
                                                                              cause, use the
                                                                              sulfaquinoxaline
                                                                              levels recommended
                                                                              for control of
                                                                              outbreaks,
                                                                              returning to the
                                                                              original dosage
                                                                              schedule after the
                                                                              outbreak has
                                                                              subsided. Losses
                                                                              may result from
                                                                              intercurrent
                                                                              disease, other
                                                                              conditions
                                                                              affecting drug
                                                                              intake, or variant
                                                                              strains of
                                                                              coccidia species
                                                                              which can
                                                                              contribute to the
                                                                              virulence of
                                                                              coccidiosis under
                                                                              field conditions.
                                                                              Do not treat
                                                                              chickens within 10
                                                                              days of slaughter.
                                                                              Do not medicate
                                                                              chickens producing
                                                                              eggs for human
                                                                              consumption.
(ii) 0.0175 percent.............  ...................  As an aid in          Feed continuously            016592
                                                        preventing            from the time
                                                        outbreaks of          birds are placed
                                                        coccidiosis caused    on litter and
                                                        by Eimeria tenella,   continue past the
                                                        E. necatrix, E.       age when
                                                        acervulina, E.        coccidiosis is
                                                        maxima, and E.        ordinarily a
                                                        brunetti where        hazard. If death
                                                        excessive exposure    losses exceed 0.5
                                                        to coccidia is        percent in a 2-day
                                                        increased due to      period, obtain a
                                                        overcrowding or       laboratory
                                                        other management      diagnosis. If
                                                        factors.              coccidiosis is the
                                                                              cause, use the
                                                                              sulfaquinoxaline
                                                                              levels recommended
                                                                              for control of
                                                                              outbreaks,
                                                                              returning to the
                                                                              original dosage
                                                                              schedule after the
                                                                              outbreak has
                                                                              subsided. Losses
                                                                              may result from
                                                                              intercurrent
                                                                              disease, other
                                                                              conditions
                                                                              affecting drug
                                                                              intake, or variant
                                                                              strains of
                                                                              coccidia species
                                                                              which can
                                                                              contribute to the
                                                                              virulence of
                                                                              coccidiosis under
                                                                              field conditions.
                                                                              Do not treat
                                                                              chickens within 10
                                                                              days of slaughter.
                                                                              Do not medicate
                                                                              chickens producing
                                                                              eggs for human
                                                                              consumption.
(iii) 0.1 to 0.05 percent.......  ...................  As an aid in          Feed at 0.1 percent          016592
                                                        controlling           level for first 48
                                                        outbreaks of          to 72 hours. Skip
                                                        coccidiosis caused    3 days; 0.05
                                                        by Eimeria tenella,   percent for 2
                                                        E. necatrix, E.       days, skip 3 days;
                                                        acervulina, E.        0.05 percent for 2
                                                        maxima, and E.        days. If bloody
                                                        brunetti.             droppings recur,
                                                                              give 0.05 percent
                                                                              for another 2
                                                                              days. Do not treat
                                                                              chickens within 10
                                                                              days of slaughter.
                                                                              Do not medicate
                                                                              chickens producing
                                                                              eggs for human
                                                                              consumption.
(iv) 0.05 or 0.1 percent........  ...................  As an aid in the      Feed 0.1 percent             016592
                                                        control of acute      for 48 to 72
                                                        fowl cholera caused   hours. Mortality
                                                        by Pasteurella        should be brought
                                                        multocida             under control.
                                                        susceptible to        After medication,
                                                        sulfaquinoxaline      move birds to
                                                        and fowl typhoid      clean ground or to
                                                        caused by             a clean house. If
                                                        Salmonella            disease recurs,
                                                        gallinarum            use 0.05 percent
                                                        susceptible to        in feed again for
                                                        sulfaquinoxaline.     2 days. Do not
                                                                              treat chickens or
                                                                              turkeys within 10
                                                                              days of slaughter
                                                                              for food. Do not
                                                                              medicate chickens
                                                                              or turkeys
                                                                              producing eggs for
                                                                              human consumption.
----------------------------------------------------------------------------------------------------------------


[[Page 514]]

    (2) Turkeys--

----------------------------------------------------------------------------------------------------------------
                                     Combination in
  Sulfaquinoxaline in grams/ton        grams/ton        Indications for use      Limitations          Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 0.0175 percent..............  ...................  As an aid in          Feed continuously            016592
                                                        preventing            during time birds
                                                        outbreaks of          are closely
                                                        coccidiosis caused    confined. May be
                                                        by Eimeria            continued for a
                                                        meleagrimitis and     week to 10 days
                                                        E. adenoeides.        after flock is
                                                                              transferred to
                                                                              range to reduce
                                                                              danger of an
                                                                              outbreak following
                                                                              moving of the
                                                                              flock. Do not
                                                                              treat turkeys
                                                                              within 10 days of
                                                                              slaughter. Do not
                                                                              medicate turkeys
                                                                              producing eggs for
                                                                              human consumption.
(ii) 0.05 percent...............  ...................  As an aid in          Feed for 2 days.             016592
                                                        controlling           Follow with 3 days
                                                        outbreaks of          on regular feed
                                                        coccidiosis caused    and 2 more days on
                                                        by Eimeria            0.05 percent
                                                        meleagrimitis and     sulfaquinoxaline
                                                        E. adenoeides.        feed. Again follow
                                                                              with 3 days on
                                                                              regular feed and 2
                                                                              more days on 0.05
                                                                              percent
                                                                              sulfaquinoxaline
                                                                              feed. Continue
                                                                              this schedule if
                                                                              necessary until
                                                                              all signs of the
                                                                              outbreaks have
                                                                              subsided. Do not
                                                                              treat turkeys
                                                                              within 10 days of
                                                                              slaughter. Do not
                                                                              medicate turkeys
                                                                              producing eggs for
                                                                              human consumption.
(iii) 0.05 or 0.1 percent.......  ...................  As an aid in the      Feed 0.1 percent             016592
                                                        control of acute      for 48 to 72
                                                        fowl cholera caused   hours. Mortality
                                                        by Pasteurella        should be brought
                                                        multocida             under control.
                                                        susceptible to        After medication,
                                                        sulfaquinoxaline      move birds to
                                                        and fowl typhoid      clean ground or to
                                                        caused by             a clean house. If
                                                        Salmonella            disease recurs,
                                                        gallinarum            use 0.05 percent
                                                        susceptible to        in feed again for
                                                        sulfaquinoxaline.     2 days. Do not
                                                                              treat chickens or
                                                                              turkeys within 10
                                                                              days of slaughter
                                                                              for food. Do not
                                                                              medicate chickens
                                                                              or turkeys
                                                                              producing eggs for
                                                                              human consumption.
----------------------------------------------------------------------------------------------------------------

    (3) Rabbits--

----------------------------------------------------------------------------------------------------------------
                                     Combination in
  Sulfaquinoxaline in grams/ton        grams/ton        Indications for use      Limitations          Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 0.025 percent...............  ...................  As an aid in          Treatment to be              016592
                                                        preventing            started after
                                                        coccidiosis caused    weaning. Feed
                                                        by Eimeria stiedae.   continuously for
                                                                              30 days or feed
                                                                              medicated feed for
                                                                              2 days out of
                                                                              every week until
                                                                              marketing. Do not
                                                                              treat within 10
                                                                              days of slaughter.
(ii) 0.1 percent................  ...................  As an aid in          Feed for 2 weeks.            016592
                                                        controlling           Do not treat
                                                        outbreaks of          within 10 days of
                                                        coccidiosis caused    slaughter.
                                                        by Eimeria stiedae.
----------------------------------------------------------------------------------------------------------------


[81 FR 95013, Dec. 27, 2016]



Sec. 558.600  Thiabendazole.

    (a) Specifications. Dry Type A medicated articles containing 22, 
44.1, 66.1, or 88.2 percent thiabendazole.
    (b) Sponsor. See No. 000010 in Sec. 510.600(c) of this chapter.
    (c) Related tolerances. See Sec. 556.730 of this chapter.
    (d) Special considerations. (1) The 66.1 percent Type A medicated 
article is solely for the manufacture of cane molasses liquid Type B 
feed, which is mixed in dry feeds.

[[Page 515]]

    (2) The 88.2 percent Type A medicated article is used solely for the 
manufacture of an aqueous slurry for adding to a Type C dry cattle feed.
    (3) Do not use in Type B or Type C medicated feed containing 
bentonite.
    (e) Conditions of use. It is used in feed for animals as follows:
    (1) Swine--

----------------------------------------------------------------------------------------------------------------
     Thiabendazole in grams/ton            Indications for use               Limitations              Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 45.4 to 908 (0.005 to 0.1         Swine: As an aid in the       Administer continuously in            000010
 percent).                             prevention of infections of   feed containing 0.05 to 0.1
                                       large roundworms (genus       percent thiabendazole per
                                       Ascaris).                     ton for 2 weeks followed by
                                                                     feed containing 0.005 to
                                                                     0.02 percent thiabendazole
                                                                     per ton for 8 to 14 weeks.
                                                                     Do not treat animals within
                                                                     30 days of slaughter.
(ii) [Reserved]
----------------------------------------------------------------------------------------------------------------

    (2) Cattle--

----------------------------------------------------------------------------------------------------------------
        Thiabendazole amount               Indications for use               Limitations              Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 3 grams per 100 lb. body weight.  For control of infections of  Use 3 grams per 100 lb. body          000010
                                       gastrointestinal roundworms   weight at a single dose;
                                       (Trichostrongylus spp.,       may repeat once in 2 to 3
                                       Haemonchus spp., Ostertagia   weeks. Do not treat animals
                                       spp., Nematodirus spp.,       within 3 days of slaughter.
                                       Oesophagostomum radiatum).    Milk taken from treated
                                                                     animals within 96 hours (8
                                                                     milkings) after the latest
                                                                     treatment must not be used
                                                                     for food.
(ii) 5 grams per 100 lb. body weight  For control of severe         Use 5 grams per 100 lb. body          000010
                                       infections of                 weight at a single dose or
                                       gastrointestinal roundworms   divided into 3 equal doses,
                                       (Trichostrongylus spp.,       administered 1 dose each
                                       Haemonchus spp., Ostertagia   day, on succeeding days.
                                       spp., Nematodirus spp.,       May repeat once in 2 to 3
                                       Oesophagostomum radiatum);    weeks. Do not treat animals
                                       control of infections of      within 3 days of slaughter.
                                       Cooperia spp.                 Milk taken from treated
                                                                     animals within 96 hours (8
                                                                     milkings) after the latest
                                                                     treatment must not be used
                                                                     for food.
----------------------------------------------------------------------------------------------------------------

    (3) Minor species--

----------------------------------------------------------------------------------------------------------------
        Thiabendazole amount               Indications for use               Limitations              Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 2 grams per 100 lb. body weight.  Sheep and goats: For control  Use 2 grams per 100 lb. body          050604
                                       of infections of              weight at a single dose. Do
                                       gastrointestinal roundworms   not treat animals within 30
                                       (Trichostrongylus spp.,       days of slaughter. Milk
                                       Haemonchus spp., Ostertagia   taken from treated animals
                                       spp., Cooperia spp.;          within 96 hours (8
                                       Nematodirus spp.,             milkings) after the latest
                                       Bunostomum spp.,              treatment must not be used
                                       Strongyloides spp.,           for food.
                                       Chabertia spp., and
                                       Oesophagostomum spp.); also
                                       active against ova and
                                       larvae passed by sheep from
                                       3 hours to 3 days after the
                                       feed is consumed (good
                                       activity against ova and
                                       larvae of T. colubriformis
                                       and axei, Ostertagia spp.,
                                       Nematodirus spp.,
                                       Strongyloides spp.; less
                                       effective against those of
                                       Haemonchus contortus and
                                       Oesophagostomum spp.).
(ii) 3 grams per 100 lb. body weight  Goats: For control of severe  Use 3 grams per 100 lb. body          050604
                                       infections of                 weight at a single dose. Do
                                       gastrointestinal roundworms   not treat animals within 30
                                       (Trichostrongylus spp.,       days of slaughter. Milk
                                       Haemonchus spp., Ostertagia   taken from treated animals
                                       spp., Cooperia spp.,          within 96 hours (8
                                       Nematodirus spp.,             milkings) after the latest
                                       Bunostomum spp.,              treatment must not be used
                                       Strongyloides spp.,           for food.
                                       Chabertia spp., and
                                       Oesophagostomum spp.).

[[Page 516]]

 
(iii) 454 grams per ton of feed.....  Pheasants: For the treatment  Feed continuously for 2               050604
                                       of gapeworms (Syngamus        weeks (14 days). Do not use
                                       trachea).                     treated pheasants for food
                                                                     for 21 days after last day
                                                                     of treatment. Fertility,
                                                                     hatchability, and other
                                                                     reproductive data are not
                                                                     available on use in
                                                                     breeding animals.
----------------------------------------------------------------------------------------------------------------


[84 FR 39186, Aug. 9, 2019, as amended at 86 FR 14827, Mar. 19, 2021]



Sec. 558.612  Tiamulin.

    (a) Specifications. Type A article containing 363.2 grams of 
tiamulin hydrogen fumarate per pound.
    (b) Sponsor. See No. 058198 in Sec. 510.600(c) of this chapter.
    (c) Related tolerances. See Sec. 556.732 of this chapter.
    (d) Special considerations. (1) Swine being treated with tiamulin 
should not have access to feeds containing polyether ionophores (e.g., 
lasalocid, monensin, narasin, salinomycin, or semduramycin) as adverse 
reactions may occur. If signs of toxicity occur, discontinue use.
    (2) The effects of tiamulin on swine reproductive performance, 
pregnancy, and lactation have not been determined.
    (3) Use as sole source of tiamulin.
    (e) Conditions of use--(1) Swine. It is used as follows:

----------------------------------------------------------------------------------------------------------------
  Tiamulin hydrogen fumarate in    Combination in grams
          grams per ton                   per ton          Indications for use        Limitations       Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 35...........................  ....................  1. For control of swine  Feed continuously       058198
                                                          dysentery associated     as sole ration on
                                                          with Brachyspira         premises with a
                                                          (formerly Serpulina or   history of swine
                                                          Treponema)               dysentery but
                                                          hyodysenteriae           where signs of
                                                          susceptible to           disease have not
                                                          tiamulin.                yet occurred or
                                                                                   following approved
                                                                                   treatment of
                                                                                   disease. Withdraw
                                                                                   2 days before
                                                                                   slaughter.
                                                         2. For control of        Feed continuously       058198
                                                          porcine proliferative    as the sole ration
                                                          enteropathies            for not less than
                                                          (ileitis) associated     10 days. Withdraw
                                                          with Lawsonia            2 days before
                                                          intracellularis.         slaughter.
(ii) 200.........................  ....................  For treatment of swine   Feed continuously       058198
                                                          dysentery associated     as the sole feed
                                                          with Brachyspira         for 14 consecutive
                                                          (formerly Serpulina or   days. Withdraw
                                                          Treponema)               feed 7 days before
                                                          hyodysenteriae           slaughter.
                                                          susceptible to
                                                          tiamulin.
----------------------------------------------------------------------------------------------------------------

    (2) Tiamulin may also be used in combination with chlortetracycline 
as in Sec. 558.128.

[67 FR 7268, Feb. 19, 2002, as amended at 69 FR 62407, Oct. 26, 2004; 70 
FR 75018, Dec. 19, 2005; 74 FR 6, Jan. 2, 2009; 77 FR 24139, Apr. 23, 
2012; 79 FR 13546, Mar. 11, 2014. Redesignated and amended at 80 FR 
13232, Mar. 13, 2015; 81 FR 95015, Dec. 27, 2016; 86 FR 14827, Mar. 19, 
2021]



Sec. 558.618  Tilmicosin.

    (a) Specifications. Type A medicated article containing 90.7 grams 
(g) per pound tilmicosin as tilmicosin phosphate (200 g per kilogram).
    (b) Sponsor. See Nos. 016592 and 058198 in Sec. 510.600(c) of this 
chapter.
    (c) Related tolerances. See Sec. 556.735 of this chapter.
    (d) Special considerations--(1) Federal law restricts medicated feed 
containing this veterinary feed directive (VFD) drug to use by or on the 
order of a licensed veterinarian. See Sec. 558.6 for additional 
requirements.
    (2) VFDs for tilmicosin phosphate shall not be refilled.
    (3) Labeling of tilmicosin Type B or Type C medicated feeds must 
bear the following warnings:

[[Page 517]]

    (i) Do not allow horses or other equines access to feeds containing 
tilmicosin.
    (ii) [Reserved]
    (4) Special considerations for use of tilmicosin medicated swine 
feeds include the following:
    (i) The expiration date of VFDs for tilmicosin must not exceed 90 
days from the time of issuance.
    (ii) Labeling of tilmicosin Type B or Type C medicated feeds for 
swine must bear the following warning: ``Do not use in any feeds 
containing bentonite. Bentonite in feeds may affect the efficacy of 
tilmicosin.''
    (iii) Feed containing tilmicosin shall not be fed to pigs for more 
than 21 days during each phase of production without ceasing 
administration for reevaluation of antimicrobial use by a licensed 
veterinarian before reinitiating a further course of therapy with an 
appropriate antimicrobial.
    (5) Special consideration for use of tilmicosin medicated cattle 
feeds include the following:
    (i) The expiration date of VFDs for cattle must not exceed 45 days 
from the time of issuance.
    (ii) Labeling of tilmicosin Type B or Type C medicated feeds for 
cattle must bear the following warning: ``Do not use in any feeds 
containing bentonite, cottonseed meal, or cottonseed hulls. Bentonite, 
cottonseed meal, or cottonseed hulls in feeds may affect the efficacy of 
tilmicosin.''
    (iii) To assure both food safety and responsible use in cattle, 
administration of feed containing tilmicosin to cattle experiencing an 
outbreak of BRD must be initiated during the first 45 days of the 
production period, shall not exceed a single 14-consecutive-day 
treatment, should not occur concurrent with or following administration 
of an injectable macrolide, and should not occur within 3 days following 
administration of a nonmacrolide injectable BRD therapy. Tilmicosin 
medicated feed treatment has not been evaluated in cattle with severe 
clinical disease. Cattle with severe clinical illness should be 
evaluated for individual treatment with an alternative non-macrolide 
therapy.
    (e) Conditions of use. It is used in feed as follows:
    (1) Swine--

----------------------------------------------------------------------------------------------------------------
  Tilmicosin phosphate in
         grams/ton            Combination in grams/ton    Indications for use        Limitations        Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 181 to 363.............  ..........................  Swine: For the         Feed continuously as     058198,
                                                          control of swine       the sole ration for      016592
                                                          respiratory disease    21-day period,
                                                          associated with        beginning
                                                          Actinobacillus         approximately 7 days
                                                          pleuropneumoniae and   before an
                                                          Pasteurella            anticipated disease
                                                          multocida.             outbreak. The safety
                                                                                 of tilmicosin has
                                                                                 not been established
                                                                                 in male swine
                                                                                 intended for
                                                                                 breeding purposes.
                                                                                 Swine intended for
                                                                                 human consumption
                                                                                 must not be
                                                                                 slaughtered within 7
                                                                                 days of the last
                                                                                 treatment with this
                                                                                 drug product.
(ii) [Reserved]............  ..........................  .....................  .....................  .........
----------------------------------------------------------------------------------------------------------------

    (2) Cattle--

[[Page 518]]



----------------------------------------------------------------------------------------------------------------
  Tilmicosin phosphate in
         grams/ton           Combination in grams/ton    Indications for use         Limitations        Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 568 to 757............  ..........................  Beef and nonlactating  Feed continuously for     058198,
                                                         dairy cattle: For      14 days to provide        016592
                                                         the control of         12.5 mg tilmicosin/kg
                                                         bovine respiratory     of bodyweight/day.
                                                         disease (BRD)          The safety of
                                                         associated with        tilmicosin has not
                                                         Mannheimia             been established in
                                                         haemolytica,           cattle intended for
                                                         Pasteurella            breeding purposes.
                                                         multocida, and         This drug product is
                                                         Histophilus somni in   not approved for use
                                                         groups of beef and     in female dairy
                                                         nonlactating dairy     cattle 20 months of
                                                         cattle, where active   age or older. Use in
                                                         BRD has been           these cattle may
                                                         diagnosed in at        cause drug residues
                                                         least 10 percent of    in milk. This drug
                                                         the animals in the     product is not
                                                         group.                 approved for use in
                                                                                calves intended to be
                                                                                processed for veal. A
                                                                                withdrawal period has
                                                                                not been established
                                                                                in preruminating
                                                                                calves. Cattle
                                                                                intended for human
                                                                                consumption must not
                                                                                be slaughtered within
                                                                                28 days of the last
                                                                                treatment with this
                                                                                drug product.
(ii) 568 to 757...........  Monensin, 5 to 40.........  Cattle fed in          Feed continuously for      016592
                                                         confinement for        14 days to provide        058198
                                                         slaughter: For         12.5 mg tilmicosin/kg
                                                         improved feed          of bodyweight/day.
                                                         efficiency; and for    The safety of
                                                         the control of         tilmicosin has not
                                                         bovine respiratory     been established in
                                                         disease (BRD)          cattle intended for
                                                         associated with        breeding purposes.
                                                         Mannheimia             This drug product is
                                                         haemolytica,           not approved for use
                                                         Pasteurella            in female dairy
                                                         multocida, and         cattle 20 months of
                                                         Histophilus somni in   age or older. Use in
                                                         groups of cattle fed   these cattle may
                                                         in confinement for     cause drug residues
                                                         slaughter, where       in milk. This drug
                                                         active BRD has been    product is not
                                                         diagnosed in at        approved for use in
                                                         least 10 percent of    calves intended to be
                                                         the animals in the     processed for veal. A
                                                         group.                 withdrawal period has
                                                                                not been established
                                                                                in pre-ruminating
                                                                                calves. Cattle
                                                                                intended for human
                                                                                consumption must not
                                                                                be slaughtered within
                                                                                28 days of the last
                                                                                treatment with this
                                                                                drug product. See
                                                                                Sec. 558.355(d).
                                                                                Tilmicosin as
                                                                                provided by No.
                                                                                016592 or 058198;
                                                                                monensin as provided
                                                                                by No. 016592 or
                                                                                058198 in Sec.
                                                                                510.600(c) of this
                                                                                chapter.
(iii) 568 to 757..........  Monensin, 10 to 40........  Cattle fed in          Feed continuously for      016592
                                                         confinement for        14 days to provide        058198
                                                         slaughter: For         12.5 mg tilmicosin/kg
                                                         prevention and         of bodyweight/day.
                                                         control of             The safety of
                                                         coccidiosis due to     tilmicosin has not
                                                         Eimeria bovis and E.   been established in
                                                         zuernii; and for the   cattle intended for
                                                         control of BRD         breeding purposes.
                                                         associated with        This drug product is
                                                         Mannheimia             not approved for use
                                                         haemolytica,           in female dairy
                                                         Pasteurella            cattle 20 months of
                                                         multocida, and         age or older. Use in
                                                         Histophilus somni in   these cattle may
                                                         groups of cattle fed   cause drug residues
                                                         in confinement for     in milk. This drug
                                                         slaughter, where       product is not
                                                         active BRD has been    approved for use in
                                                         diagnosed in at        calves intended to be
                                                         least 10 percent of    processed for veal. A
                                                         the animals in the     withdrawal period has
                                                         group.                 not been established
                                                                                in pre-ruminating
                                                                                calves. Cattle
                                                                                intended for human
                                                                                consumption must not
                                                                                be slaughtered within
                                                                                28 days of the last
                                                                                treatment with this
                                                                                drug product. See
                                                                                Sec. 558.355(d).
                                                                                Tilmicosin as
                                                                                provided by No.
                                                                                016592 or 058198;
                                                                                monensin as provided
                                                                                by No. 016592 or
                                                                                058198 in Sec.
                                                                                510.600(c) of this
                                                                                chapter.
----------------------------------------------------------------------------------------------------------------


[[Page 519]]


[61 FR 68148, Dec. 27, 1996; 62 FR 15391, Apr. 1, 1997, as amended at 64 
FR 13679, Mar. 22, 1999; 65 FR 76930, Dec. 8, 2000; 67 FR 21997, May 2, 
2002; 69 FR 78306, Dec. 30, 2004; 76 FR 76894, Dec. 9, 2011; 77 FR 
60623, Oct. 4, 2012; 78 FR 19987, Apr. 3, 2013; 80 FR 61298, Oct. 13, 
2015; 80 FR 76387, Dec. 9, 2015; 81 FR 48703, July 26, 2016; 81 FR 
59135, Aug. 29, 2016; 81 FR 67153, Sept. 30, 2016; 85 FR 18123, Apr. 1, 
2020; 86 FR 14827, Mar. 19, 2021]



Sec. 558.625  Tylosin.

    (a) Specifications. Type A medicated articles containing tylosin 
phosphate.
    (b) Sponsors. See sponsor numbers in Sec. 510.600(c) of this 
chapter.
    (1) No. 016592: Type A medicated articles containing 40 or 100 grams 
per pound (g/lb).
    (2) No. 054771: Type A medicated article containing 40 g/lb.
    (3) No. 058198: Type A medicated articles containing 10, 40, or 100 
g/lb.
    (4) No. 066104: Type A medicated articles containing 20 or 40 g/lb.
    (c) Related tolerances. See Sec. 556.746 of this chapter.
    (d) Special considerations. (1) Federal law restricts medicated feed 
containing this veterinary feed directive (VFD) drug to use by or on the 
order of a licensed veterinarian. See Sec. 558.6 for additional 
requirements.
    (2) The expiration date of VFDs for tylosin medicated feeds must not 
exceed 6 months from the date of issuance. VFDs for tylosin shall not be 
refilled.
    (3) Type C medicated feeds for cattle may be manufactured from 
tylosin liquid Type B medicated feeds which have a pH between 4.5 and 
6.0 and which bear appropriate mixing directions as follows:
    (i) For liquid feeds stored in recirculating tank systems: 
Recirculate immediately prior to use for not less than 10 minutes, 
moving not less than 1 percent of the tank contents per minute from the 
bottom of the tank to the top. Recirculate daily as described even when 
not used.
    (ii) For liquid feeds stored in mechanical, air, or other agitation-
type tank systems: Agitate immediately prior to use for not less than 10 
minutes, creating a turbulence at the bottom of the tank that is visible 
at the top. Agitate daily as described even when not used.
    (4) Tylosin liquid Type B medicated feeds must bear an expiration 
date of 31 days after the date of manufacture.
    (5) Do not use tylosin liquid Type B medicated feeds in any liquid 
feed containing sodium metabisulfite or in any finished feed 
(supplement, concentrate, or complete feed) containing in excess of 2 
percent bentonite.
    (e) Conditions of use--(1) Swine--

----------------------------------------------------------------------------------------------------------------
                                     Combination in
        Tylosin grams/ton              grams/ton        Indications for use      Limitations         Sponsors
----------------------------------------------------------------------------------------------------------------
(i) 40 or 100...................  ...................  For control of swine  Feed as the sole             016592
                                                        dysentery             ration 100 g of             054771
                                                        associated with       tylosin per ton of          058198
                                                        Brachyspira           complete feed for           066104
                                                        hyodysenteriae.       at least 3 weeks.
                                                                              Follow with 40
                                                                              grams per ton of
                                                                              complete feed
                                                                              until market
                                                                              weight.
(ii) 40 or 100..................  Pyrantel, 96.......  For control of swine  Feed as the sole             066104
                                                        dysentery             ration 100 g of
                                                        associated with       tylosin per ton of
                                                        Brachyspira           complete feed for
                                                        hyodysenteriae; and   at least 3 weeks.
                                                        as an aid in the      Follow with 40
                                                        prevention of         grams per ton of
                                                        migration and         complete feed
                                                        establishment of      until market
                                                        large roundworm       weight. Tylosin
                                                        (Ascaris suum)        phosphate and
                                                        infections; aid in    pyrantel as
                                                        the prevention of     provided by No.
                                                        establishment of      066104 in Sec.
                                                        nodular worm          510.600(c) of this
                                                        (Oesophagostomum      chapter.
                                                        spp.) infections.
(iii) 40 or 100.................  ...................  For control of        Feed as the sole             016592
                                                        porcine               ration 100 g of             054771
                                                        proliferative         tylosin per ton of          058198
                                                        enteropathies         complete feed for           066104
                                                        (ileitis)             at least 3 weeks.
                                                        associated with       Follow with 40
                                                        Lawsonia              grams per ton of
                                                        intracellularis.      complete feed
                                                                              until market
                                                                              weight.

[[Page 520]]

 
(iv) 40 or 100..................  Pyrantel, 96.......  For control of        Feed as the sole             066104
                                                        porcine               ration 100 g of
                                                        proliferative         tylosin per ton of
                                                        enteropathies         complete feed for
                                                        (ileitis)             at least 3 weeks.
                                                        associated with       Follow with 40
                                                        Lawsonia              grams per ton of
                                                        intracellularis;      complete feed
                                                        and as an aid in      until market
                                                        the prevention of     weight. Tylosin
                                                        migration and         phosphate and
                                                        establishment of      pyrantel as
                                                        large roundworm       provided by No.
                                                        (Ascaris suum)        066104 in Sec.
                                                        infections; aid in    510.600(c) of this
                                                        the prevention of     chapter.
                                                        establishment of
                                                        nodular worm
                                                        (Oesophagostomum
                                                        spp.) infections.
(v) 40 or 100...................  Ractopamine, 4.5 to  Finishing swine: For  Feed continuously            016592
                                   9.0.                 the control of        as the sole ration          054771
                                                        swine dysentery       to finishing swine          058198
                                                        associated with       weighing not less
                                                        Brachyspira           than 150 lbs for
                                                        hyodysenteriae; for   the last 45 to 90
                                                        control of porcine    lbs (group
                                                        proliferative         average) of weight
                                                        enteropathies         gain prior to
                                                        (ileitis)             slaughter. Include
                                                        associated with       100 g/ton of
                                                        Lawsonia              tylosin for at
                                                        intracellularis;      least 3 weeks,
                                                        and for increased     followed by 40 g/
                                                        rate of weight        ton until market
                                                        gain, improved feed   weight. Tylosin
                                                        efficiency, and       phosphate as
                                                        increased carcass     provided by Nos.
                                                        leanness in           058198 and 016592;
                                                        finishing swine       ractopamine as
                                                        weighing not less     provided by Nos.
                                                        than 150 lbs, fed a   058198 and 054771
                                                        complete ration       in Sec.
                                                        containing at least   510.600(c) of this
                                                        16% crude protein     chapter.
                                                        for the last 45 to
                                                        90 lbs of gain
                                                        prior to slaughter.
(vi) 40 to 100..................  ...................  For the treatment     Administer as                016592
                                                        and control of        tylosin phosphate           054771
                                                        swine dysentery       in feed                     058198
                                                        associated with       continuously as             066104
                                                        Brachyspira           the sole ration
                                                        hyodysenteriae        for 2 to 6 weeks,
                                                        immediately after     immediately after
                                                        medicating with       treatment with
                                                        tylosin in drinking   tylosin tartrate
                                                        water.                in drinking water
                                                                              for 3 to 10 days
                                                                              as in Sec.
                                                                              520.2640(d)(3) of
                                                                              this chapter.
(vii) 40 or 100.................  Pyrantel, 96.......  For the treatment     Administer as                066104
                                                        and control of        tylosin phosphate
                                                        swine dysentery       in feed
                                                        associated with       continuously as
                                                        Brachyspira           the sole ration
                                                        hyodysenteriae        for 2 to 6 weeks,
                                                        immediately after     immediately after
                                                        medicating with       treatment with
                                                        tylosin in drinking   tylosin tartrate
                                                        water; and as an      in drinking water
                                                        aid in the            for 3 to 10 days
                                                        prevention of         as in Sec.
                                                        migration and         520.2640(d)(3) of
                                                        establishment of      this chapter.
                                                        large roundworm       Tylosin phosphate
                                                        (Ascaris suum)        and pyrantel as
                                                        infections; aid in    provided by No.
                                                        the prevention of     066104 in Sec.
                                                        establishment of      510.600(c) of this
                                                        nodular worm          chapter.
                                                        (Oesophagostomum
                                                        spp.) infections.
(viii) 40 to 100................  ...................  For the control of    Administer as                016592
                                                        porcine               tylosin phosphate           054771
                                                        proliferative         in feed                     058198
                                                        enteropathies (PPE,   continuously as             066104
                                                        ileitis) associated   the sole ration
                                                        with Lawsonia         for 2 to 6 weeks,
                                                        intracellularis       immediately after
                                                        immediately after     treatment with
                                                        medicating with       tylosin tartrate
                                                        tylosin in drinking   in drinking water
                                                        water.                for 3 to 10 days
                                                                              as in Sec.
                                                                              520.2640(d)(3) of
                                                                              this chapter.
(ix) 40 or 100..................  Pyrantel, 96.......  For the control of    Administer as                066104
                                                        porcine               tylosin phosphate
                                                        proliferative         in feed
                                                        enteropathies (PPE,   continuously as
                                                        ileitis) associated   the sole ration
                                                        with Lawsonia         for 2 to 6 weeks,
                                                        intracellularis       immediately after
                                                        immediately after     treatment with
                                                        medicating with       tylosin tartrate
                                                        tylosin in drinking   in drinking water
                                                        water; and as an      for 3 to 10 days
                                                        aid in the            as in Sec.
                                                        prevention of         520.2640(d)(3) of
                                                        migration and         this chapter.
                                                        establishment of      Tylosin phosphate
                                                        large roundworm       and pyrantel as
                                                        (Ascaris suum)        provided by No.
                                                        infections; aid in    066104 in Sec.
                                                        the prevention of     510.600(c) of this
                                                        establishment of      chapter.
                                                        nodular worm
                                                        (Oesophagostomum
                                                        spp.) infections.

[[Page 521]]

 
(x) 40 to 100...................  Ractopamine, 4.5 to  Finishing swine: For  Feed continuously            016592
                                   9.0.                 the treatment and     as the sole ration          054771
                                                        control of swine      to finishing swine          058198
                                                        dysentery             weighing not less
                                                        associated with       than 150 lbs for
                                                        Brachyspira           the last 45 to 90
                                                        hyodysenteriae, for   lbs (group
                                                        control of porcine    average) of weight
                                                        proliferative         gain prior to
                                                        enteropathies (PPE,   slaughter. Include
                                                        ileitis) associated   40 to 100 grams of
                                                        with Lawsonia         tylosin phosphate
                                                        intracellularis;      per ton of
                                                        and for increased     complete feed for
                                                        rate of weight        2 to 6 weeks,
                                                        gain, improved feed   immediately after
                                                        efficiency, and       treatment with
                                                        increased carcass     tylosin tartrate
                                                        leanness in           in drinking water
                                                        finishing swine       for 3 to 10 days
                                                        weighing not less     as in Sec.
                                                        than 150 lbs, fed a   520.2640(d)(3) of
                                                        complete ration       this chapter.
                                                        containing at least   Tylosin phosphate
                                                        16% crude protein     as provided by
                                                        for the last 45 to    Nos. 058198 and
                                                        90 lbs of gain        016592;
                                                        prior to slaughter.   ractopamine as
                                                                              provided by Nos.
                                                                              058198 and 054771
                                                                              in Sec.
                                                                              510.600(c) of this
                                                                              chapter.
(xi) 100........................  ...................  For reduction in      Feed continuously            016592
                                                        severity of effects   as the sole ration.         054771
                                                        of atrophic                                       058198
                                                        rhinitis.                                         066104
(xii) 100.......................  Pyrantel, 96.......  For reduction in      Feed continuously            066104
                                                        severity of effects   as the sole
                                                        of atrophic           ration. Tylosin
                                                        rhinitis; aid as an   phosphate and
                                                        aid in the            pyrantel as
                                                        prevention of         provided by No.
                                                        migration and         066104 in Sec.
                                                        establishment of      510.600(c) of this
                                                        large roundworm       chapter. Tylosin
                                                        (Ascaris suum)        phosphate and
                                                        infections; aid in    pyrantel as
                                                        the prevention of     provided by No.
                                                        establishment of      066104 in Sec.
                                                        nodular worm          510.600(c) of this
                                                        (Oesophagostomum      chapter.
                                                        spp.) infections.
(xiii) 100......................  Ractopamine, 4.5 to  For the control of    Feed continuously            016592
                                   9.0.                 porcine               as the sole ration          054771
                                                        proliferative         to finishing swine          058198
                                                        enteropathies (PPE,   weighing not less
                                                        ileitis) associated   than 150 lbs for
                                                        with Lawsonia         the last 45 to 90
                                                        intracellularis;      lbs (group
                                                        and for increased     average) of weight
                                                        rate of weight        gain prior to
                                                        gain, improved feed   slaughter. Include
                                                        efficiency, and       100 g/ton of
                                                        increased carcass     tylosin for 3
                                                        leanness in           weeks. Tylosin
                                                        finishing swine       phosphate as
                                                        weighing not less     provided by Nos.
                                                        than 150 lbs, fed a   058198 and 016592;
                                                        complete ration       ractopamine as
                                                        containing at least   provided by Nos.
                                                        16% crude protein     058198 and 054771
                                                        for the last 45 to    in Sec.
                                                        90 lbs of gain        510.600(c) of this
                                                        prior to slaughter.   chapter.
----------------------------------------------------------------------------------------------------------------

    (2) Cattle--

----------------------------------------------------------------------------------------------------------------
                                     Combination in
        Tylosin grams/ton              grams/ton        Indications for use      Limitations         Sponsors
----------------------------------------------------------------------------------------------------------------
(i) 8 to 10.....................  ...................  Beef cattle: For      Feed continuously            016592
                                                        reduction of          as the sole ration          054771
                                                        incidence of liver    to provide 60 to            058198
                                                        abscesses caused by   90 mg/head/day              066104
                                                        Fusobacterium         tylosin.
                                                        necrophorum and
                                                        Arcanobacterium
                                                        (Actinomyces)
                                                        pyogenes.

[[Page 522]]

 
(ii) 8 to 10....................  Lasalocid, 100 to    Heifers fed in        Feed continuously            016592
                                   1440; plus           confinement for       as sole ration.             054771
                                   melengestrol, 0.25   slaughter: For        Feed to heifers at          058198
                                   to 2.0.              reduction of          the rate of 0.5 to
                                                        incidence of liver    2.0 pound(s) per
                                                        abscesses caused by   head per day
                                                        Fusobacterium         (specify one
                                                        necrophorum and       level) to provide
                                                        Arcanobacterium       0.25 to 0.5 mg
                                                        pyogenes; and for     melengestrol
                                                        increased rate of     acetate per head
                                                        weight gain,          per day (specify
                                                        improved feed         one level), 100 to
                                                        efficiency, and       360 mg lasalocid
                                                        suppression of        per head per day
                                                        estrus (heat).        (specify one
                                                                              level), and 90 mg
                                                                              tylosin per head
                                                                              per day. This Type
                                                                              C product may be
                                                                              top dressed onto
                                                                              or mixed into a
                                                                              complete feed
                                                                              prior to feeding.
                                                                              Tylosin as
                                                                              provided by Nos.
                                                                              016592 and 058198;
                                                                              lasalocid as
                                                                              provided by No.
                                                                              054771;
                                                                              melengestrol as
                                                                              provided by Nos.
                                                                              054771 and 058198
                                                                              in Sec.
                                                                              510.600(c) of this
                                                                              chapter. See Sec.
                                                                              Sec. 558.311(d)
                                                                              and 558.342(d) in
                                                                              this chapter.
(iii) 8 to 10...................  Melengestrol, 0.25   Heifers fed in        Feed continuously            016592
                                   to 2.0.              confinement for       as sole ration.             054771
                                                        slaughter: For        Each pound                  058198
                                                        reduction of          contains 0.125 to
                                                        incidence of liver    1.0 mg
                                                        abscesses caused by   melengestrol
                                                        Fusobacterium         acetate and 45 to
                                                        necrophorum and       180 mg of tylosin.
                                                        Arcanobacterium       Feed to heifers at
                                                        pyogenes; and for     a rate of 0.5 to
                                                        increased rate of     2.0 pounds per
                                                        weight gain,          head per day to
                                                        improved feed         provide 0.25 to
                                                        efficiency, and       0.5 mg
                                                        suppression of        melengestrol
                                                        estrus (heat).        acetate and 60 to
                                                                              90 mg tylosin per
                                                                              head per day.
                                                                              Prior to feeding,
                                                                              this Type C
                                                                              product must be
                                                                              top-dressed onto a
                                                                              complete feed or
                                                                              mixed into the
                                                                              amount of complete
                                                                              feed consumed by
                                                                              an animal per day.
                                                                              Tylosin provided
                                                                              by Nos. 016592 and
                                                                              058198;
                                                                              melengestrol
                                                                              provided by Nos.
                                                                              054771 and 058198
                                                                              in Sec.
                                                                              510.600(c) of this
                                                                              chapter. See Sec.
                                                                               558.342(d) in
                                                                              this chapter.
(iv) 8 to 10....................  Monensin, 5 to 40..  Cattle fed in         Feed continuously            016592
                                                        confinement for       as sole ration to           058198
                                                        slaughter: For        provide 50 to 480
                                                        reduction of          monensin mg/head/
                                                        incidence of liver    day and 60 to 90
                                                        abscesses caused by   mg/head/day
                                                        Fusobacterium         tylosin. A
                                                        necrophorum and       withdrawal time
                                                        Arcanobacterium       has not been
                                                        (Actinomyces)         established for
                                                        pyogenes; and for     pre-ruminating
                                                        improved feed         calves. Do not use
                                                        efficiency.           in calves to be
                                                                              processed for
                                                                              veal. Tylosin
                                                                              provided by Nos.
                                                                              016592 or 058198;
                                                                              monensin as
                                                                              provided by Nos.
                                                                              016592 or 058198
                                                                              in Sec.
                                                                              510.600(c) of this
                                                                              chapter. See Sec.
                                                                               558.355(d) in
                                                                              this chapter.

[[Page 523]]

 
(v) 8 to 10.....................  Monensin, 10 to 40.  Cattle fed in         Feed continuously            016592
                                                        confinement for       as sole ration to           058198
                                                        slaughter: For        provide 0.14 to
                                                        reduction of          0.42 mg monensin/
                                                        incidence of liver    lb body weight per
                                                        abscesses caused by   day, depending on
                                                        Fusobacterium         the severity of
                                                        necrophorum and       the coccidiosis
                                                        Arcanobacterium       challenge, up to
                                                        (Actinomyces)         480 mg/head/day
                                                        pyogenes; and for     and 60 to 90 mg/
                                                        prevention of         head/day tylosin.
                                                        coccidiosis caused    A withdrawal time
                                                        by Eimeria bovis      has not been
                                                        and E zuernii.        established for
                                                                              pre-ruminating
                                                                              calves. Do not use
                                                                              in calves to be
                                                                              processed for
                                                                              veal. Tylosin
                                                                              provided by Nos.
                                                                              016592 or 058198;
                                                                              monensin as
                                                                              provided by Nos.
                                                                              016592 or 058198
                                                                              in Sec.
                                                                              510.600(c) of this
                                                                              chapter. See Sec.
                                                                               558.355(d) in
                                                                              this chapter.
(vi) 8 to 10....................  Monensin, 5 to 30    Cattle fed in         Feed continuously            016592
                                   plus decoquinate,    confinement for       as the sole ration          054771
                                   13.6 to 22.7.        slaughter: For        to provide 22.7 mg
                                                        reduction of          of decoquinate per
                                                        incidence of liver    100 lb body weight
                                                        abscesses caused by   per day, 50 to 360
                                                        Fusobacterium         mg of monensin/
                                                        necrophorum and       head/day, and 60
                                                        Arcanobacterium       to 90 mg of
                                                        pyogenes; for the     tylosin/head/day.
                                                        prevention of         Feed at least 28
                                                        coccidiosis caused    days during period
                                                        by Eimeria bovis      of exposure to
                                                        and E. zuernii; and   coccidiosis or
                                                        for improved feed     when it is likely
                                                        efficiency.           to be a hazard. Do
                                                                              not feed to
                                                                              animals producing
                                                                              milk for food. Do
                                                                              not feed to
                                                                              lactating dairy
                                                                              cattle. A
                                                                              withdrawal time
                                                                              has not been
                                                                              established for
                                                                              pre-ruminating
                                                                              calves. Do not use
                                                                              in calves to be
                                                                              processed for
                                                                              veal. Tylosin as
                                                                              provided by No.
                                                                              016592 or 058198;
                                                                              monensin as
                                                                              provided by No.
                                                                              016592 or 058198;
                                                                              decoquinate as
                                                                              provided by No.
                                                                              058198 in Sec.
                                                                              510.600(c) of this
                                                                              chapter. See Sec.
                                                                              Sec. 558.311(d)
                                                                              and 558.355(d).

[[Page 524]]

 
(vii) 8 to 10...................  Monensin, 5 to 40    Beef steers and       Feed continuously            058198
                                   plus lubabegron      heifers fed in        as sole ration to
                                   fumarate, 1.25 to    confinement for       provide 13 to 90
                                   4.54.                slaughter: For        mg lubabegron/head/
                                                        reduction of          day, 50 to 480 mg
                                                        ammonia gas           monensin/head/day,
                                                        emissions per pound   and 60 to 90 mg
                                                        of live weight and    tylosin/head/day
                                                        hot carcass weight;   during the last 14
                                                        for reduction of      to 91 days on
                                                        incidence of liver    feed. No
                                                        abscesses             additional
                                                        associated with       improvement in
                                                        Fusobacterium         feed efficiency
                                                        necrophorum and       has been shown
                                                        Arcanobacterium       from feeding
                                                        pyogenes, and for     monensin at levels
                                                        improved feed         greater than 30 g/
                                                        efficiency during     ton (360 mg
                                                        the last 14 to 91     monensin/head/day.
                                                        days on feed.         A decrease in dry
                                                                              matter intake may
                                                                              be noticed in some
                                                                              animals receiving
                                                                              lubabegron.
                                                                              Lubabegron has not
                                                                              been approved for
                                                                              use in breeding
                                                                              animals because
                                                                              safety and
                                                                              effectiveness have
                                                                              not been evaluated
                                                                              in these animals.
                                                                              Do not allow
                                                                              horses or other
                                                                              equines access to
                                                                              feed containing
                                                                              lubabegron and
                                                                              monensin.
                                                                              Ingestion of
                                                                              monensin by horses
                                                                              has been fatal.
                                                                              Monensin medicated
                                                                              cattle and goat
                                                                              feeds are safe for
                                                                              use in cattle and
                                                                              goats only.
                                                                              Consumption by
                                                                              unapproved species
                                                                              may result in
                                                                              toxic reactions.
                                                                              Feeding undiluted
                                                                              or mixing errors
                                                                              resulting in high
                                                                              concentrations of
                                                                              monensin has been
                                                                              fatal to cattle
                                                                              and could be fatal
                                                                              to goats. Must be
                                                                              thoroughly mixed
                                                                              in feeds before
                                                                              use. Do not exceed
                                                                              the levels of
                                                                              monensin
                                                                              recommended in the
                                                                              feeding
                                                                              directions, as
                                                                              reduced average
                                                                              daily gains may
                                                                              result. If feed
                                                                              refusals
                                                                              containing
                                                                              monensin are fed
                                                                              to other groups of
                                                                              cattle, the
                                                                              concentration of
                                                                              monensin in the
                                                                              refusals and
                                                                              amount of refusals
                                                                              fed should be
                                                                              taken into
                                                                              consideration to
                                                                              prevent monensin
                                                                              overdosing. A
                                                                              withdrawal period
                                                                              has not been
                                                                              established for
                                                                              this product for
                                                                              preruminating
                                                                              calves. Do not use
                                                                              in calves to be
                                                                              processed for veal.

[[Page 525]]

 
(viii) 8 to 10..................  Monensin, 10 to 40   Beef steers and       Feed continuously            058198
                                   plus lubabegron      heifers fed in        as sole ration to
                                   fumarate, 1.25 to    confinement for       provide 13 to 90
                                   4.54.                slaughter: For        mg lubabegron/head/
                                                        reduction of          day, 0.14 to 0.42
                                                        ammonia gas           mg monensin/lb
                                                        emissions per pound   body weight per
                                                        of live weight and    day, depending
                                                        hot carcass weight,   upon severity of
                                                        for reduction of      coccidiosis
                                                        incidence of liver    challenge, up to
                                                        abscesses             480 mg/head/day,
                                                        associated with       and 60 to 90 mg
                                                        Fusobacterium         tylosin/head/day
                                                        necrophorum and       during the last 14
                                                        Arcanobacterium       to 91 days on
                                                        pyogenes, and for     feed. A decrease
                                                        prevention and        in dry matter
                                                        control of            intake may be
                                                        coccidiosis due to    noticed in some
                                                        Eimeria bovis and     animals receiving
                                                        E. zuernii during     lubabegron.
                                                        the last 14 to 91     Lubabegron has not
                                                        days on feed.         been approved for
                                                                              use in breeding
                                                                              animals because
                                                                              safety and
                                                                              effectiveness have
                                                                              not been evaluated
                                                                              in these animals.
                                                                              Do not allow
                                                                              horses or other
                                                                              equines access to
                                                                              feed containing
                                                                              lubabegron and
                                                                              monensin.
                                                                              Ingestion of
                                                                              monensin by horses
                                                                              has been fatal.
                                                                              Monensin medicated
                                                                              cattle and goat
                                                                              feeds are safe for
                                                                              use in cattle and
                                                                              goats only.
                                                                              Consumption by
                                                                              unapproved species
                                                                              may result in
                                                                              toxic reactions.
                                                                              Feeding undiluted
                                                                              or mixing errors
                                                                              resulting in high
                                                                              concentrations of
                                                                              monensin has been
                                                                              fatal to cattle
                                                                              and could be fatal
                                                                              to goats. Must be
                                                                              thoroughly mixed
                                                                              in feeds before
                                                                              use. Do not exceed
                                                                              the levels of
                                                                              monensin
                                                                              recommended in the
                                                                              feeding
                                                                              directions, as
                                                                              reduced average
                                                                              daily gains may
                                                                              result. If feed
                                                                              refusals
                                                                              containing
                                                                              monensin are fed
                                                                              to other groups of
                                                                              cattle, the
                                                                              concentration of
                                                                              monensin in the
                                                                              refusals and
                                                                              amount of refusals
                                                                              fed should be
                                                                              taken into
                                                                              consideration to
                                                                              prevent monensin
                                                                              overdosing. A
                                                                              withdrawal period
                                                                              has not been
                                                                              established for
                                                                              this product for
                                                                              preruminating
                                                                              calves. Do not use
                                                                              in calves to be
                                                                              processed for veal.

[[Page 526]]

 
(ix) 8 to 10....................  Monensin, 10 to 40   Heifers fed in        Feed continuously            016592
                                   plus melengestrol,   confinement for       as sole ration to           054771
                                   0.25 to 2.0.         slaughter: For        heifers at a rate           058198
                                                        reduction of          of 0.5 to 2 pounds
                                                        incidence of liver    per head per day
                                                        abscesses caused by   to provide 0.25 to
                                                        Fusobacterium         0.5 mg/head/day
                                                        necrophorum and       melengestrol
                                                        Arcanobacterium       acetate and 0.14
                                                        (Actinomyces)         to 0.42 mg
                                                        pyogenes; for         monensin/lb body
                                                        prevention and        weight per day,
                                                        control of            depending on the
                                                        coccidiosis caused    severity of the
                                                        by Eimeria bovis      coccidiosis
                                                        and E. zuernii; and   challenge, up to
                                                        for increased rate    480 mg/head/day
                                                        of weight gain,       and 60 to 90 mg/
                                                        improved feed         head/day tylosin.
                                                        efficiency, and       The melengestrol
                                                        suppression of        acetate portion of
                                                        estrus (heat).        this Type C
                                                                              medicated feed
                                                                              must be mixed into
                                                                              the complete feed
                                                                              containing 10 to
                                                                              40 g/ton monensin
                                                                              and 8 to 10 g/ton
                                                                              tylosin at feeding
                                                                              into the amount of
                                                                              complete feed
                                                                              consumed by an
                                                                              animal per day. A
                                                                              withdrawal time
                                                                              has not been
                                                                              established for
                                                                              pre-ruminating
                                                                              calves. Do not use
                                                                              in calves to be
                                                                              processed for
                                                                              veal. Tylosin
                                                                              provided by No.
                                                                              016592 or 058198;
                                                                              monensin as
                                                                              provided by No.
                                                                              016592 or 058198;
                                                                              melengestrol
                                                                              provided by No.
                                                                              054771 or 058198
                                                                              in Sec.
                                                                              510.600(c) of this
                                                                              chapter. See Sec.
                                                                              Sec. 558.342(d)
                                                                              and 558.355(d).
(x) 8 to 10.....................  Monensin, 10 to 40   Cattle fed in         Feed continuously            016592
                                   plus ractopamine,    confinement for       as sole ration to           054771
                                   8.2 to 24.6.         slaughter: For        provide 70 to 430           058198
                                                        reduction of          mg/head/day
                                                        incidence of liver    ractopamine and
                                                        abscesses caused by   0.14 to 0.42 mg
                                                        Fusobacterium         monensin/lb body
                                                        necrophorum and       weight per day,
                                                        Arcanobacterium       depending on the
                                                        pyogenes; for         severity of the
                                                        prevention and        coccidiosis
                                                        control of            challenge, up to
                                                        coccidiosis caused    480 mg/head/day
                                                        by Eimeria bovis      and 60 to 90 mg/
                                                        and E zuernii; and    head/day tylosin
                                                        for increased rate    for the last 28 to
                                                        of weight gain and    42 days on feed. A
                                                        improved feed         withdrawal time
                                                        efficiency in         has not been
                                                        cattle fed in         established for
                                                        confinement for       pre-ruminating
                                                        slaughter for the     calves. Do not use
                                                        last 28 to 42 days    in calves to be
                                                        on feed.              processed for
                                                                              veal. Tylosin
                                                                              provided by Nos.
                                                                              016592 or 058198;
                                                                              monensin as
                                                                              provided by Nos.
                                                                              016592 or 058198;
                                                                              ractopamine
                                                                              provided by Nos.
                                                                              054771 or 058198
                                                                              in Sec.
                                                                              510.600(c) of this
                                                                              chapter. See Sec.
                                                                              Sec. 558.355(d)
                                                                              and 558.500(d) in
                                                                              this chapter.

[[Page 527]]

 
(xi) 8 to 10....................  Monensin, 10 to 40   Cattle fed in         Feed a minimum of            016592
                                   plus ractopamine,    confinement for       1.0 lb/head/day             054771
                                   not to exceed 800.   slaughter: For        ractopamine Type C          058198
                                                        reduction of          top dress feed
                                                        incidence of liver    continuously to
                                                        abscesses caused by   cattle fed in
                                                        Fusobacterium         confinement for
                                                        necrophorum and       slaughter, to
                                                        Arcanobacterium       provide 70 to 400
                                                        pyogenes; for         mg/head/day
                                                        prevention and        ractopamine for
                                                        control of            the last 28 to 42
                                                        coccidiosis caused    days on feed. Feed
                                                        by Eimeria bovis      on top of a ration
                                                        and E zuernii; and    containing 10 to
                                                        for increased rate    40 g/ton monensin
                                                        of weight gain and    and 8 to 10 g/ton
                                                        improved feed         tylosin phosphate,
                                                        efficiency in         to provide 0.14 to
                                                        cattle fed in         0.42 mg monensin/
                                                        confinement for       lb body weight/
                                                        slaughter for the     day, depending on
                                                        last 28 to 42 days    the severity of
                                                        on feed.              the coccidiosis
                                                                              challenge, up to
                                                                              480 mg/head/day
                                                                              and 60 to 90 mg/
                                                                              head/day tylosin.
                                                                              A withdrawal time
                                                                              has not been
                                                                              established for
                                                                              pre-ruminating
                                                                              calves. Do not use
                                                                              in calves to be
                                                                              processed for
                                                                              veal. Tylosin
                                                                              provided by Nos.
                                                                              016592 or 058198;
                                                                              monensin as
                                                                              provided by Nos.
                                                                              016592 or 058198;
                                                                              ractopamine
                                                                              provided by Nos.
                                                                              054771 or 058198
                                                                              in Sec.
                                                                              510.600(c) of this
                                                                              chapter. See Sec.
                                                                              Sec. 558.355(d)
                                                                              and 558.500(d) in
                                                                              this chapter.
(xii) 8 to 10...................  Monensin 10 to 40    Cattle fed in         Feed continuously            016592
                                   plus ractopamine     confinement for       as sole ration to           054771
                                   9.8 to 24.6.         slaughter: For        provide 90 to 430           058198
                                                        reduction of          mg/head/day
                                                        incidence of liver    ractopamine and
                                                        abscesses caused by   0.14 to 0.42 mg
                                                        Fusobacterium         monensin/lb body
                                                        necrophorum and       weight per day,
                                                        Arcanobacterium       depending on the
                                                        pyogenes; for         severity of the
                                                        prevention and        coccidiosis
                                                        control of            challenge, up to
                                                        coccidiosis caused    480 mg/head/day
                                                        by Eimeria bovis      and 60 to 90 mg/
                                                        and E zuernii; and    head/day tylosin
                                                        for increased rate    for the last 28 to
                                                        of weight gain,       42 days on feed. A
                                                        improved feed         withdrawal time
                                                        efficiency, and       has not been
                                                        increased carcass     established for
                                                        leanness in cattle    pre-ruminating
                                                        fed in confinement    calves. Do not use
                                                        for slaughter for     in calves to be
                                                        the last 28 to 42     processed for
                                                        days on feed.         veal. Tylosin
                                                                              provided by Nos.
                                                                              016592 or 058198;
                                                                              monensin as
                                                                              provided by Nos.
                                                                              016592 or 058198;
                                                                              ractopamine as
                                                                              provided by Nos.
                                                                              054771 or 058198
                                                                              in Sec.
                                                                              510.600(c) of this
                                                                              chapter. See Sec.
                                                                              Sec. 558.355(d)
                                                                              and 558.500(d) in
                                                                              this chapter.

[[Page 528]]

 
(xiii) 8 to 10..................  Monensin, 10 to 40   Heifers fed in        Feed continuously            016592
                                   plus ractopamine,    confinement for       as sole ration to           054771
                                   9.8 to 24.6 plus     slaughter: For        provide 90 to 430           058198
                                   melengestrol,        reduction of          mg/head/day
                                   0.125 to 1 mg/lb.    incidence of liver    ractopamine and
                                                        abscesses caused by   0.14 to 0.42 mg
                                                        Fusobacterium         monensin/lb body
                                                        necrophorum and       weight per day,
                                                        Arcanobacterium       depending on the
                                                        (Actinomyces)         severity of the
                                                        pyogenes; for         coccidiosis
                                                        prevention and        challenge, up to
                                                        control of            480 mg/head/day
                                                        coccidiosis caused    and 60 to 90 mg/
                                                        by Eimeria bovis      head/day tylosin
                                                        and E zuernii; for    for the last 28 to
                                                        increased rate of     42 days on feed.
                                                        weight gain,          Feed melengestrol
                                                        improved feed         as a top dress or
                                                        efficiency, and       mixed with a
                                                        increased carcass     complete ration at
                                                        leanness; and         the rate of 0.5 to
                                                        suppression of        2.0 pound/head/day
                                                        estrus (heat).        (specify one
                                                                              level) to provide
                                                                              0.25 to 0.5 mg
                                                                              melengestrol
                                                                              acetate/head/day
                                                                              (specify one
                                                                              level). A
                                                                              withdrawal time
                                                                              has not been
                                                                              established for
                                                                              pre-ruminating
                                                                              calves. Do not use
                                                                              in calves to be
                                                                              processed for
                                                                              veal. Tylosin
                                                                              provided by Nos.
                                                                              016592 or 058198;
                                                                              monensin as
                                                                              provided by Nos.
                                                                              016592 or 058198;
                                                                              ractopamine as
                                                                              provided by Nos.
                                                                              054771 or 058198
                                                                              in Sec.
                                                                              510.600(c) of this
                                                                              chapter. See Sec.
                                                                              Sec. 558.342(d),
                                                                              558.355(d), and
                                                                              558.500(d) in this
                                                                              chapter.
(xiv) 8 to 10...................  Monensin, 10 to 40   Cattle fed in         Feed continuously            000061
                                   plus zilpaterol,     confinement for       as the sole ration          016592
                                   6.8.                 slaughter: For        to cattle during
                                                        reduction of          the last 20 to 40
                                                        incidence of liver    days on feed to
                                                        abscesses caused by   provide 60 to 90
                                                        Fusobacterium         mg/head/day
                                                        necrophorum and       zilpaterol, 0.14
                                                        Arcanobacterium       to 0.42 mg/lb body
                                                        pyogenes; for         weight/day
                                                        prevention and        monensin,
                                                        control of            depending on the
                                                        coccidiosis caused    severity of the
                                                        by Eimeria bovis      coccidiosis
                                                        and E zuernii; and    challenge, up to
                                                        for increased rate    480 mg/head/day
                                                        of weight gain,       monensin, and 60
                                                        improved feed         to 90 mg/head/day
                                                        efficiency, and       tylosin. Do not
                                                        increased carcass     use in veal
                                                        leanness in cattle    calves. Withdrawal
                                                        fed in confinement    period 3 days.
                                                        for slaughter for     Tylosin provided
                                                        the last 20 to 40     by Nos. 016592 or
                                                        days on feed.         058198; monensin
                                                                              as provided by No.
                                                                              058198; zilpaterol
                                                                              as provided by No.
                                                                              000061 in Sec.
                                                                              510.600(c) of this
                                                                              chapter. See Sec.
                                                                              Sec. 558.355(d)
                                                                              and 558.665(d) in
                                                                              this chapter.
(xv) 8 to 10....................  Monensin, 10 to 40   Cattle fed in         Feed this component          000061
                                   plus zilpaterol,     confinement for       feed continuously           016592
                                   6.8 to 24.           slaughter: For        to cattle during
                                                        reduction of          the last 20 to 40
                                                        incidence of liver    days on feed to
                                                        abscesses caused by   provide 60 mg/head/
                                                        Fusobacterium         day zilpaterol,
                                                        necrophorum and       0.14 to 0.42 mg/lb
                                                        Arcanobacterium       body weight/day
                                                        pyogenes; for         monensin,
                                                        prevention and        depending on the
                                                        control of            severity of the
                                                        coccidiosis caused    coccidiosis
                                                        by Eimeria bovis      challenge, up to
                                                        and E zuernii; and    480 mg/head/day
                                                        for increased rate    monensin, and 60
                                                        of weight gain,       to 90 mg/head/day
                                                        improved feed         tylosin. Do not
                                                        efficiency, and       use in veal
                                                        increased carcass     calves. Withdrawal
                                                        leanness in cattle    period 3 days.
                                                        fed in confinement    Tylosin provided
                                                        for slaughter for     by Nos. 016592 or
                                                        the last 20 to 40     058198; monensin
                                                        days on feed.         as provided by No.
                                                                              058198; zilpaterol
                                                                              as provided by No.
                                                                              000061 in Sec.
                                                                              510.600(c) of this
                                                                              chapter. See Sec.
                                                                              Sec. 558.355(d)
                                                                              and 558.665(d) in
                                                                              this chapter.

[[Page 529]]

 
(xvi) 8 to 10...................  Monensin, 10 to 40   Heifers fed in        Feed continuously            000061
                                   plus zilpaterol,     confinement for       as the sole ration          016592
                                   6.8 plus             slaughter: For        to cattle during            058198
                                   melengestrol,        reduction of          the last 20 to 40
                                   0.125 to 1 mg/lb.    incidence of liver    days on feed to
                                                        abscesses caused by   provide 60 to 90
                                                        Fusobacterium         mg/head/day
                                                        necrophorum and       zilpaterol, 0.14
                                                        Arcanobacterium       to 0.42 mg/lb body
                                                        (Actinomyces)         weight/day
                                                        pyogenes; for         monensin,
                                                        prevention and        depending on the
                                                        control of            severity of the
                                                        coccidiosis caused    coccidiosis
                                                        by Eimeria bovis      challenge, up to
                                                        and E zuernii; and    480 mg/head/day
                                                        for increased rate    monensin, and 60
                                                        of weight gain,       to 90 mg/head/day
                                                        improved feed         tylosin. Feed
                                                        efficiency, and       melengestrol as a
                                                        increased carcass     top dress or mixed
                                                        leanness in cattle    with a complete
                                                        fed in confinement    ration at the rate
                                                        for slaughter for     of 0.5 to 2.0
                                                        the last 20 to 40     pound/head/day
                                                        days on feed; and     (specify one
                                                        for suppression of    level) to provide
                                                        estrus (heat).        0.25 to 0.5 mg
                                                                              melengestrol
                                                                              acetate/head/day
                                                                              (specify one
                                                                              level). Do not use
                                                                              in veal calves.
                                                                              Withdrawal period
                                                                              3 days. Tylosin as
                                                                              provided by Nos.
                                                                              016592 or 058198;
                                                                              monensin as
                                                                              provided by No.
                                                                              058198; zilpaterol
                                                                              as provided by No.
                                                                              000061;
                                                                              melengestrol
                                                                              provided by Nos.
                                                                              054771 or 058198
                                                                              in Sec.
                                                                              510.600(c) of this
                                                                              chapter. See Sec.
                                                                              Sec. 558.342(d),
                                                                              558.355(d) and
                                                                              558.665(d) in this
                                                                              chapter.
(xvii) 8 to 10..................  Monensin, 10 to 40   Heifers fed in        Feed this component          000061
                                   plus zilpaterol,     confinement for       feed continuously           016592
                                   6.8 to 24 plus       slaughter: For        to cattle during            058198
                                   melengestrol,        reduction of          the last 20 to 40
                                   0.125 to 1 mg/lb.    incidence of liver    days on feed to
                                                        abscesses caused by   provide 60 mg/head/
                                                        Fusobacterium         day zilpaterol,
                                                        necrophorum and       0.14 to 0.42 mg/lb
                                                        Arcanobacterium       body weight/day
                                                        (Actinomyces)         monensin,
                                                        pyogenes; for         depending on the
                                                        prevention and        severity of the
                                                        control of            coccidiosis
                                                        coccidiosis caused    challenge, up to
                                                        by Eimeria bovis      480 mg/head/day
                                                        and E zuernii; and    monensin, and 60
                                                        for increased rate    to 90 mg/head/day
                                                        of weight gain,       tylosin. Feed
                                                        improved feed         melengestrol as a
                                                        efficiency, and       top dress or mixed
                                                        increased carcass     with a complete
                                                        leanness in cattle    ration at the rate
                                                        fed in confinement    of 0.5 to 2.0
                                                        for slaughter for     pound/head/day
                                                        the last 20 to 40     (specify one
                                                        days on feed; and     level) to provide
                                                        for suppression of    0.25 to 0.5 mg
                                                        estrus (heat).        melengestrol
                                                                              acetate/head/day
                                                                              (specify one
                                                                              level). Do not use
                                                                              in veal calves.
                                                                              Withdrawal period
                                                                              3 days. Tylosin as
                                                                              provided by Nos.
                                                                              016592 or 058198;
                                                                              monensin as
                                                                              provided by No.
                                                                              058198; zilpaterol
                                                                              as provided by No.
                                                                              000061;
                                                                              melengestrol
                                                                              provided by Nos.
                                                                              054771 or 058198
                                                                              in Sec.
                                                                              510.600(c) of this
                                                                              chapter. See Sec.
                                                                              Sec. 558.342(d),
                                                                              558.355(d) and
                                                                              558.665(d) in this
                                                                              chapter.
----------------------------------------------------------------------------------------------------------------


[40 FR 13959, Mar. 27, 1975]

    Editorial Note: For Federal Register citations affecting Sec. 
558.625, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and at www.govinfo.gov.



Sec. 558.630  Tylosin and sulfamethazine.

    (a) Specifications. Type A medicated articles containing equal 
amounts of tylosin phosphate and sulfamethazine, available in 
concentrations of 5, 10, 20, or 40 grams each, per pound.

[[Page 530]]

    (b) Sponsors. See sponsor numbers in Sec. 510.600(c) of this 
chapter.
    (1) No. 058198 for use as in paragraph (e)(1) of this section.
    (2) No. 054771: 10 or 40 grams per pound each for use as in 
paragraph (e)(2) of this section.
    (c) Related tolerances. See Sec. Sec. 556.670 and 556.746 of this 
chapter.
    (d) Special considerations. (1) Federal law restricts medicated feed 
containing this veterinary feed directive (VFD) drug to use by or on the 
order of a licensed veterinarian. See Sec. 558.6 for additional 
requirements.
    (2) The expiration date of VFDs for tylosin and sulfamethazine 
medicated feeds must not exceed 6 months from the date of issuance. VFDs 
for tylosin and sulfamethazine shall not be refilled.
    (3) Labeling shall bear the statement: ``Do not use in medicated 
feeds containing in excess of 2% bentonite.''
    (e) Conditions of use. It is used in feed for swine as follows:

----------------------------------------------------------------------------------------------------------------
      Tylosin phosphate and          Combination in
   sulfamethazine in grams/ton         grams/ton        Indications for use      Limitations         Sponsors
----------------------------------------------------------------------------------------------------------------
(1) 100 each....................  ...................  For reduction in the  Withdraw 15 days             058198
                                                        severity of effects   before swine are
                                                        of atrophic           slaughtered.
                                                        rhinitis; lowering
                                                        the incidence and
                                                        severity of
                                                        Bordetella
                                                        bronchiseptica
                                                        rhinitis;
                                                        prevention of swine
                                                        dysentery
                                                        associated with
                                                        Brachyspira
                                                        hyodysenteriae;
                                                        control of swine
                                                        pneumonias caused
                                                        by bacterial
                                                        pathogens
                                                        (Pasteurella
                                                        multocida and/or
                                                        Arcanobacterium
                                                        pyogenes); reducing
                                                        the incidence of
                                                        cervical
                                                        lymphadenitis (jowl
                                                        abscesses) caused
                                                        by Group E
                                                        Streptococci. Only
                                                        the sulfamethazine
                                                        portion of this
                                                        combination is
                                                        active in
                                                        controlling jowl
                                                        abscesses.
(2) 100 each....................  ...................  For reduction in the  Withdraw 15 days             054771
                                                        severity of effects   before swine are
                                                        of atrophic           slaughtered.
                                                        rhinitis; lowering
                                                        the incidence and
                                                        severity of
                                                        Bordetella
                                                        bronchiseptica
                                                        rhinitis;
                                                        prevention of swine
                                                        dysentery
                                                        associated with
                                                        Brachyspira
                                                        hyodysenteriae; and
                                                        control of swine
                                                        pneumonias caused
                                                        by bacterial
                                                        pathogens
                                                        (Pasteurella
                                                        multocida and/or
                                                        Arcanobacterium
                                                        pyogenes).
----------------------------------------------------------------------------------------------------------------


[81 FR 95021, Dec. 27, 2016, as amended at 84 FR 33002, July 11, 2019]



Sec. 558.633  Tylvalosin.

    (a) Specifications. Type A medicated articles containing 77.12 grams 
tylvalosin per pound as tylvalosin tartrate.
    (b) Sponsor. See No. 066916 in Sec. 510.600(c) of this chapter.
    (c) Related tolerances. See Sec. 556.748 of this chapter.
    (d) Special considerations. (1) Federal law restricts medicated feed 
containing

this veterinary feed directive (VFD) drug to use by or on the order of a 
licensed veterinarian. See Sec. 558.6 for additional requirements.
    (2) VFDs for tylvalosin shall not be refilled.
    (3) An expiration date of 1 week is required for tylvalosin Type C 
medicated swine feeds in pelleted or crumbled form.
    (e) Conditions of use.

[[Page 531]]



----------------------------------------------------------------------------------------------------------------
 Tylvalosin in  grams/ton          Indications for use                      Limitations                Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 38.6                   Swine: For the control of porcine    Feed continuously as the sole             066916
                            proliferative enteropathy (PPE)      ration for 14 consecutive days.
                            associated with Lawsonia
                            intracellularis infection in
                            groups of swine in buildings
                            experiencing an outbreak of PPE.
(ii) [Reserved]
----------------------------------------------------------------------------------------------------------------


[81 FR 36790, June 8, 2016, as amended at 81 FR 67153, Sept. 30, 2016; 
84 FR 12504, Apr. 2, 2019]



Sec. 558.635  Virginiamycin.

    (a) Specifications. Type A medicated articles containing 10, 20, 50, 
or 227 grams virginiamycin per pound.
    (b) Sponsors. See No. 066104 in Sec. 510.600(c) of this chapter.
    (c) Related tolerances. See Sec. 556.750 of this chapter.
    (d) Special considerations. (1) Federal law restricts medicated feed 
containing this veterinary feed directive (VFD) drug to use by or on the 
order of a licensed veterinarian. See Sec. 558.6 for additional 
requirements.
    (2) The expiration date of VFDs for virginiamycin medicated feeds 
must not exceed 6 months from the date of issuance. VFDs for 
virginiamycin shall not be refilled.
    (3) Not for use in breeding swine over 120 pounds.
    (4) Dilute Type A article with at least 10 pounds of a feed 
ingredient prior to final mixing in 1 ton of Type C feed.
    (e) Conditions of use--(1) Chickens--

----------------------------------------------------------------------------------------------------------------
                                     Combination in
     Virginiamycin grams/ton           grams/ton        Indications for use      Limitations         Sponsors
----------------------------------------------------------------------------------------------------------------
(i) 20..........................  ...................  Broiler chickens:     Not for use in               066104
                                                        For prevention of     layers.
                                                        necrotic enteritis
                                                        caused by
                                                        Clostridium
                                                        perfringens
                                                        susceptible to
                                                        virginiamycin.
(ii) 20.........................  Amprolium 72.6 to    Broiler chickens:     For field                    066104
                                   113.5.               For prevention of     conditions where
                                                        necrotic enteritis    only E. tenella is
                                                        caused by             the major problem,
                                                        Clostridium           feed continuously
                                                        perfringens           as the sole
                                                        susceptible to        ration. Use as the
                                                        virginiamycin; and    sole source of
                                                        for the prevention    amprolium. Do not
                                                        of coccidiosis        use in feeds
                                                        caused by Eimeria     containing
                                                        tenella.              bentonite. Not for
                                                                              use in laying
                                                                              chickens.
                                                                              Amprolium as
                                                                              provided by No.
                                                                              016592 in Sec.
                                                                              510.600(c) of this
                                                                              chapter.
(iii) 20........................  Amprolium 113.5 to   Broiler chickens:     For most field               066104
                                   227.                 For prevention of     conditions as they
                                                        necrotic enteritis    exist under modern
                                                        caused by             management
                                                        Clostridium           practices, feed
                                                        perfringens           113.5 g/ton
                                                        susceptible to        amprolium
                                                        virginiamycin; and    continuously.
                                                        for the prevention    Where severe
                                                        of coccidiosis        coccidiosis
                                                        where immunity to     conditions exist,
                                                        coccidiosis is not    feed 227 g/ton.
                                                        desired.              Use as the sole
                                                                              source of
                                                                              amprolium. Do not
                                                                              use in feeds
                                                                              containing
                                                                              bentonite. Not for
                                                                              use in laying
                                                                              chickens.
                                                                              Amprolium as
                                                                              provided by No.
                                                                              016592 in Sec.
                                                                              510.600(c) of this
                                                                              chapter.

[[Page 532]]

 
(iv) 20.........................  Diclazuril 0.91....  Broiler chickens:     Feed continuously            058198
                                                        For prevention of     as the sole
                                                        necrotic enteritis    ration. Do not use
                                                        caused by             in hens producing
                                                        Clostridium           eggs for human
                                                        perfringens           food. Diclazuril
                                                        susceptible to        as provided by No.
                                                        virginiamycin; and    058198 in Sec.
                                                        for the prevention    510.600(c) of this
                                                        of coccidiosis        chapter.
                                                        caused by Eimeria
                                                        tenella, E.
                                                        necatrix, E.
                                                        acervulina, E.
                                                        brunetti, E. mitis
                                                        (mivati), and E.
                                                        maxima. Because
                                                        diclazuril is
                                                        effective against
                                                        E. maxima late in
                                                        its life cycle,
                                                        subclinical
                                                        intestinal lesions
                                                        may be present for
                                                        a short time after
                                                        infection.
                                                        Diclazuril was
                                                        shown in studies to
                                                        reduce lesions
                                                        scores and improve
                                                        performance and
                                                        health of birds
                                                        challenged with E.
                                                        maxima.
(v) 20..........................  Lasalocid 68 to 113  Broiler chickens:     Feed continuously            066104
                                                        For prevention of     as the sole
                                                        necrotic enteritis    ration. Do not
                                                        caused by             feed to laying
                                                        Clostridium           chickens. For
                                                        perfringens           broiler or fryer
                                                        susceptible to        chickens only.
                                                        virginiamycin; and    Lasalocid as
                                                        for the prevention    provided by No.
                                                        of coccidiosis        054771 in Sec.
                                                        caused by Eimeria     510.600(c) of this
                                                        tenella, E.           chapter.
                                                        necatrix, E.
                                                        acervulina, E.
                                                        brunetti, E.
                                                        mivati, and E.
                                                        maxima.
(vi) 20.........................  Monensin 90 to 110.  Broiler chickens:     Feed continuously            066104
                                                        For prevention of     as the sole
                                                        necrotic enteritis    ration. Do not
                                                        caused by             feed to laying
                                                        Clostridium           chickens. See Sec.
                                                        perfringens             558.355(d) in
                                                        susceptible to        this chapter.
                                                        virginiamycin; and    Monensin as
                                                        as an aid in the      provided by No.
                                                        prevention of         058198 in Sec.
                                                        coccidiosis caused    510.600(c) of this
                                                        by Eimeria            chapter.
                                                        necatrix, E.
                                                        tenella, E.
                                                        acervulina, E.
                                                        brunetti, E.
                                                        maxima, and E.
                                                        mivati.
(vii) 20........................  Salinomycin 40 to    Broiler chickens:     Feed continuously
                                   60.                  For prevention of     as the sole
                                                        necrotic enteritis    ration. Do not
                                                        caused by             feed to chickens
                                                        Clostridium           over 16 weeks of
                                                        perfringens           age. Do not feed
                                                        susceptible to        to laying
                                                        virginiamycin; and    chickens. Not
                                                        for the prevention    approved for use
                                                        of coccidiosis        with pellet
                                                        caused by Eimeria     binders. May be
                                                        tenella, E.           fatal if
                                                        necatrix, E.          accidentally fed
                                                        acervulina, E.        to adult turkeys
                                                        maxima, E.            or horses.
                                                        brunetti, and E.      Salinomycin as
                                                        mivati.               provided by No.
                                                                              016592 in Sec.
                                                                              510.600(c) of this
                                                                              chapter.
(viii) 20.......................  Semduramicin 22.7..  Broiler chickens:     Feed continuously            066104
                                                        For prevention of     as the sole
                                                        necrotic enteritis    ration. Do not
                                                        caused by             feed to laying
                                                        Clostridium           hens. Semduramicin
                                                        perfringens           as provided by No.
                                                        susceptible to        066104 in Sec.
                                                        virginiamycin; and    510.600(c) of this
                                                        for the prevention    chapter.
                                                        of coccidiosis
                                                        caused by Eimeria
                                                        acervulina, E.
                                                        brunetti, E.
                                                        maxima, E mivati/
                                                        mitis, E. necatrix,
                                                        and E. tenella.
(ix) 20.........................  Semduramicin         Broiler chickens:     Feed continuously            066104
                                   (biomass) 22.7.      For prevention of     as the sole
                                                        necrotic enteritis    ration. Withdraw 1
                                                        caused by             day before
                                                        Clostridium           slaughter. Do not
                                                        perfringens           feed to laying
                                                        susceptible to        hens. Semduramicin
                                                        virginiamycin; and    as provided by No.
                                                        for the prevention    066104 in Sec.
                                                        of coccidiosis        510.600(c) of this
                                                        caused by Eimeria     chapter.
                                                        acervulina, E.
                                                        brunetti, E.
                                                        maxima, E mivati/
                                                        mitis, E. necatrix,
                                                        and E. tenella.
----------------------------------------------------------------------------------------------------------------

    (2) Swine--

[[Page 533]]



----------------------------------------------------------------------------------------------------------------
                                     Combination in
     Virginiamycin grams/ton           grams/ton        Indications for use      Limitations          Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 25..........................  ...................  Growing-finishing     ...................          066104
                                                        swine: As an aid in
                                                        control of
                                                        dysentery in swine
                                                        up to 120 pounds in
                                                        animals or on
                                                        premises with a
                                                        history of swine
                                                        dysentery but where
                                                        symptoms have not
                                                        yet occurred.
(ii) 50 or 100..................  ...................  Growing-finishing     Feed 100 grams per           066104
                                                        swine: For            ton for 2 weeks,
                                                        treatment and         50 grams per ton
                                                        control of swine      thereafter.
                                                        dysentery in swine
                                                        up to 120 pounds.
(iii) 100.......................  ...................  Growing-finishing     Feed for 2 weeks...          066104
                                                        swine: For
                                                        treatment of swine
                                                        dysentery in
                                                        nonbreeding swine
                                                        over 120 pounds.
----------------------------------------------------------------------------------------------------------------

    (3) Cattle--

----------------------------------------------------------------------------------------------------------------
                                     Combination in
     Virginiamycin grams/ton           grams/ton        Indications for use      Limitations          Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 13.5 to 16.0................  ...................  Cattle fed in         Feed continuously            066104
                                                        confinement for       as the sole ration
                                                        slaughter: For        to provide 85 to
                                                        reduction of          240 milligrams per
                                                        incidence of liver    head per day. Not
                                                        abscesses.            for use in animals
                                                                              intended for
                                                                              breeding.
(ii) [Reserved]
----------------------------------------------------------------------------------------------------------------


[81 FR 95022, Dec. 27, 2016, as amended at 82 FR 11512, Feb. 24, 2017; 
82 FR 21692, May 10, 2017; 85 FR 18125, Apr. 1, 2020]



Sec. 558.665  Zilpaterol.

    (a) Specifications. Type A medicated articles containing 21.77 grams 
(g) zilpaterol hydrochloride per pound.
    (b) Approvals. See No. 000061 in Sec. 510.600(c) of this chapter.
    (c) Tolerances. See Sec. 556.765 of this chapter.
    (d) Special considerations. (1) Labeling shall bear the following 
caution statements: ``Zilpaterol hydrochloride is not for use in animals 
intended for breeding. Do not allow horses or other equines access to 
feed containing zilpaterol. Do not use in veal calves.''
    (2) Labeling of Type A medicated articles and Type B medicated feeds 
used to manufacture complete Type C medicated feeds shall bear the 
caution statement in paragraph (d)(3) of this section.
    (3) Labeling of complete Type C medicated feeds shall bear the 
following caution statements: ``Not to be fed to cattle in excess of 90 
mg zilpaterol/head/day in complete feed. If pen consumption of complete 
feed exceeds 26.5 lb/head/day (90 percent dry matter basis), zilpaterol 
should not be fed in complete feed.''
    (4) Type B Liquid Feeds can be manufactured containing 68 to 680 g 
zilpaterol hydrochloride/ton. The liquid Type B feeds must be maintained 
at a pH of 3.8 to 7.5. For liquid feeds stored in recirculating tank 
systems: Recirculate immediately prior to use for not less than 10 
minutes, moving not less than 1 percent of the tank contents per minute 
from the bottom of the tank to the top. Recirculate daily as described 
even when not used. For liquid feeds stored in mechanical, air or other 
agitation-type tank systems: Agitate immediately prior to use for not 
less than 10 minutes, creating a turbulence at the bottom of the tank 
that is visible at the top. Agitate daily as described even when not 
used.
    (e) Conditions of use in cattle. It is administered in feed as 
follows:

[[Page 534]]



----------------------------------------------------------------------------------------------------------------
Zilpaterol hydrochloride in grams/  Combination in grams/
                ton                          ton            Indications for use       Limitations       Sponsor
----------------------------------------------------------------------------------------------------------------
(1) 6.8...........................  .....................  Cattle fed in         Feed continuously as     000061
                                                            confinement for       the sole ration
                                                            slaughter: For        during the last 20
                                                            increased rate of     to 40 days on feed
                                                            weight gain,          to provide 60 to 90
                                                            improved feed         mg zilpaterol
                                                            efficiency, and       hydrochloride per
                                                            increased carcass     head per day.
                                                            leanness in cattle    Withdrawal period:
                                                            fed in confinement    3 days. See
                                                            for slaughter         paragraph (d) of
                                                            during the last 20    this section.
                                                            to 40 days on feed.
(2) 6.8...........................  Monensin 10 to 40....  Cattle fed in         Feed continuously as     000061
                                                            confinement for       the sole ration         058198
                                                            slaughter: For        during the last 20
                                                            increased rate of     to 40 days on feed
                                                            weight gain,          to provide 60 to 90
                                                            improved feed         mg zilpaterol
                                                            efficiency, and       hydrochloride per
                                                            increased carcass     head per day and
                                                            leanness in cattle    0.14 to 0.42 mg
                                                            fed in confinement    monensin per pound
                                                            for slaughter         of body weight per
                                                            during the last 20    day depending on
                                                            to 40 days on feed;   the severity of the
                                                            for prevention and    coccidiosis
                                                            control of            challenge, up to
                                                            coccidiosis due to    480 mg/head/day
                                                            Eimeria bovis and     monensin.
                                                            E. zuernii.           Withdrawal period:
                                                                                  3 days. See
                                                                                  paragraph (d) of
                                                                                  this section. See
                                                                                  paragraph Sec.
                                                                                  558.355(d) of this
                                                                                  chapter Monensin as
                                                                                  provided by No.
                                                                                  058198 in Sec.
                                                                                  510.600(c) of this
                                                                                  chapter.
(3) 6.8...........................  Melengestrol acetate   Heifers fed in        Feed continuously as     000061
                                     to provide 0.25 to     confinement for       the sole ration         058198
                                     0.5 mg/head/day.       slaughter: For        during the last 20
                                                            increased rate of     to 40 days on feed
                                                            weight gain,          to provide 60 to 90
                                                            improved feed         mg zilpaterol
                                                            efficiency, and       hydrochloride per
                                                            increased carcass     head per day.
                                                            leanness in cattle    Withdrawal period:
                                                            fed in confinement    3 days. See
                                                            for slaughter         paragraph (d) of
                                                            during the last 20    this section.
                                                            to 40 days on feed;  Melengestrol acetate
                                                            and for suppression   as provided by Nos.
                                                            of estrus (heat).     058198 or 054771 in
                                                                                  Sec. 510.600(c)
                                                                                  of this chapter.
(4) 6.8...........................  Monensin 10 to 40      Heifers fed in        Feed continuously as     000061
                                     plus melengestrol      confinement for       the sole ration         058198
                                     acetate to provide     slaughter: For        during the last 20
                                     0.25 to 0.5 mg/head/   increased rate of     to 40 days on feed
                                     day.                   weight gain,          to provide 60 to 90
                                                            improved feed         mg zilpaterol
                                                            efficiency, and       hydrochloride per
                                                            increased carcass     head per day and
                                                            leanness in cattle    0.14 to 0.42 mg
                                                            fed in confinement    monensin per pound
                                                            for slaughter         of body weight per
                                                            during the last 20    day depending on
                                                            to 40 days on feed;   the severity of the
                                                            for prevention and    coccidiosis
                                                            control of            challenge, up to
                                                            coccidiosis due to    480 mg/head/day
                                                            Eimeria bovis and     monensin.
                                                            E. zuernii; and for   Withdrawal period:
                                                            suppression of        3 days. See
                                                            estrus (heat).        paragraph (d) of
                                                                                  this section. See
                                                                                  paragraphs Sec.
                                                                                  Sec. 558.342(d)
                                                                                  and 558.355(d) of
                                                                                  this chapter.
                                                                                 Monensin as provided
                                                                                  by No. 058198;
                                                                                  melengestrol
                                                                                  acetate as provided
                                                                                  by Nos. 058198 or
                                                                                  054771 in Sec.
                                                                                  510.600(c) of this
                                                                                  chapter.
(5)-(6) [Reserved]................
(7) 6.8 to 24.....................  .....................  Cattle fed in         Feed continuously        000061
                                                            confinement for       during the last 20
                                                            slaughter: For        to 40 days on feed
                                                            increased rate of     to provide 60 mg
                                                            weight gain,          zilpaterol
                                                            improved feed         hydrochloride per
                                                            efficiency, and       head per day.
                                                            increased carcass     Withdrawal period:
                                                            leanness in cattle    3 days. See
                                                            fed in confinement    paragraph (d) of
                                                            for slaughter         this section.
                                                            during the last 20
                                                            to 40 days on feed.

[[Page 535]]

 
(8) 6.8 to 24.....................  Monensin 10 to 40....  Cattle fed in         Feed continuously        000061
                                                            confinement for       during the last 20
                                                            slaughter: For        to 40 days on feed
                                                            increased rate of     to provide 60 mg
                                                            weight gain,          zilpaterol
                                                            improved feed         hydrochloride per
                                                            efficiency, and       head per day and
                                                            increased carcass     0.14 to 0.42 mg
                                                            leanness in cattle    monensin per pound
                                                            fed in confinement    of body weight per
                                                            for slaughter         day depending on
                                                            during the last 20    the severity of the
                                                            to 40 days on feed;   coccidiosis
                                                            and for prevention    challenge, up to
                                                            and control of        480 mg/head/day
                                                            coccidiosis due to    monensin.
                                                            Eimeria bovis and     Withdrawal period:
                                                            E. zuernii.           3 days. See
                                                                                  paragraph (d) of
                                                                                  this section. See
                                                                                  paragraph Sec.
                                                                                  558.355(d) of this
                                                                                  chapter.
                                                                                 Monensin as provided
                                                                                  by No. 058198 in
                                                                                  Sec. 510.600(c)
                                                                                  of this chapter.
(9) 6.8 to 24.....................  Melengestrol acetate   Heifers fed in        Feed continuously        000061
                                     to provide 0.25 to     confinement for       during the last 20
                                     0.5 mg/head/day.       slaughter: For        to 40 days on feed
                                                            increased rate of     to provide 60 mg
                                                            weight gain,          zilpaterol
                                                            improved feed         hydrochloride per
                                                            efficiency, and       head per day.
                                                            increased carcass     Withdrawal period:
                                                            leanness in cattle    3 days. See
                                                            fed in confinement    paragraph (d) of
                                                            for slaughter         this section. See
                                                            during the last 20    paragraph Sec.
                                                            to 40 days on feed;   558.342(d) of this
                                                            and for suppression   part.
                                                            of estrus (heat).    Melengestrol acetate
                                                                                  as provided by No.
                                                                                  054771 in Sec.
                                                                                  510.600(c) of this
                                                                                  chapter.
(10) 6.8 to 24....................  Monensin 10 to 40,     Heifers fed in        Feed continuously        000061
                                     plus melengestrol      confinement for       during the last 20
                                     acetate to provide     slaughter: For        to 40 days on feed
                                     0.25 to 0.5 mg/head/   increased rate of     to provide 60 mg
                                     day.                   weight gain,          zilpaterol
                                                            improved feed         hydrochloride per
                                                            efficiency, and       head per day and
                                                            increased carcass     0.14 to 0.42 mg
                                                            leanness in cattle    monensin per pound
                                                            fed in confinement    of body weight per
                                                            for slaughter         day depending on
                                                            during the last 20    the severity of the
                                                            to 40 days on feed;   coccidiosis
                                                            for prevention and    challenge, up to
                                                            control of            480 mg/head/day
                                                            coccidiosis due to    monensin.
                                                            Eimeria bovis and     Withdrawal period:
                                                            E. zuernii; and for   3 days. See
                                                            suppression of        paragraph (d) of
                                                            estrus (heat).        this section. See
                                                                                  paragraphs Sec.
                                                                                  Sec. 558.342(d)
                                                                                  and 558.355(d) of
                                                                                  this chapter.
                                                                                 Monensin as provided
                                                                                  by No. 058198;
                                                                                  melengestrol
                                                                                  acetate as provided
                                                                                  by No. 054771 in
                                                                                  Sec. 510.600(c)
                                                                                  of this chapter.
----------------------------------------------------------------------------------------------------------------

    (f) Zilpaterol may also be used in combination with tylosin as in 
Sec. 558.625.

[71 FR 53006, Sept. 8, 2006, as amended at 72 FR 9245, Mar. 1, 2007; 72 
FR 6019, Feb. 1, 2008; 73 FR 14385, Mar. 18, 2008; 73 FR 16755, Mar. 31, 
2008; 73 FR 18959, Apr. 8, 2008; 73 FR 19432, Apr. 10, 2008; 74 FR 
61517, Nov. 25, 2009; 75 FR 11451, Mar. 11, 2010; 77 FR 31724, May 30, 
2012; 78 FR 42008, July 15, 2013; 78 FR 52852, Aug. 27, 2013; 80 FR 
13232, Mar. 13, 2015; 80 FR 53460, Sept. 4, 2015; 81 FR 48703, July 26, 
2016; 81 FR 95025, Dec. 27, 2016]



Sec. 558.680  Zoalene.

    (a) Specifications. Type A medicated article containing 25 percent 
zoalene.
    (b) Sponsors. See Nos. 054771 and 058198 in Sec. 510.600(c) of this 
chapter.
    (c) Related tolerances. See Sec. 556.770 of this chapter.
    (d) Conditions of use--(1) Chickens--

----------------------------------------------------------------------------------------------------------------
                                     Combination in grams
       Zoalene in grams/ton                per ton          Indications for use       Limitations       Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 36.3 to 113.5.................  .....................  Replacement           Feed continuously as     054771
                                                            chickens: For         sole ration. Grower     058198
                                                            development of        ration not to be
                                                            active immunity to    fed to birds over
                                                            coccidiosis.          14 weeks of age.
                                                                                  Starter ration not
                                                                                  to be fed to laying
                                                                                  birds.
----------------------------------------------------------------------------------------------------------------


[[Page 536]]


----------------------------------------------------------------------------------------------------------------
                                                                  Starter ration Grams   Grower ration Grams per
                      Growing conditions                                per ton                    ton
----------------------------------------------------------------------------------------------------------------
Severe exposure...............................................          113.5 (0.0125%)               75.4-113.5
                                                                                               (0.0083%-0.0125%)
Light to moderate exposure....................................               75.4-113.5                36.3-75.4
                                                                      (0.0083%-0.0125%)         (0.004%-0.0083%)
----------------------------------------------------------------------------------------------------------------


----------------------------------------------------------------------------------------------------------------
                                     Combination in grams
       Zoalene in grams/ton                per ton          Indications for use       Limitations       Sponsor
----------------------------------------------------------------------------------------------------------------
(ii) 36.3-113.5...................  Bacitracin             Replacement           Feed continuously as     054771
                                     methylenedisalicylat   chickens: For         sole ration as in
                                     e 4 to 50.             development of        subtable in item
                                                            active immunity to    (i). Grower ration
                                                            coccidiosis; and      not to be fed to
                                                            for increased rate    birds over 14 weeks
                                                            of weight gain and    of age. Bacitracin
                                                            improved feed         methylenedisalicyla
                                                            efficiency.           te as provided by
                                                                                  No. 054771 in Sec.
                                                                                   510.600(c) of this
                                                                                  chapter.
(iii) 36.3-113.5..................  Bacitracin             Replacement           Feed continuously as     054771
                                     methylenedisalicylat   chickens: For         sole ration as in
                                     e 50.                  development of        subtable in item
                                                            active immunity to    (i). Grower ration
                                                            coccidiosis; and as   not to be fed to
                                                            an aid in the         birds over 14 weeks
                                                            prevention of         of age. Bacitracin
                                                            necrotic enteritis    methylenedisalicyla
                                                            caused or             te as provided by
                                                            complicated by        No. 054771 in Sec.
                                                            Clostridium spp. or    510.600(c) of this
                                                            other organisms       chapter.
                                                            susceptible to
                                                            bacitracin.
(iv) 36.3-113.5...................  Bacitracin             Replacement           Feed continuously as     054771
                                     methylenedisalicylat   chickens: For         sole ration as in
                                     e 100 to 200.          development of        subtable in item
                                                            active immunity to    (i). To control
                                                            coccidiosis; and as   necrotic enteritis,
                                                            an aid in the         start medication at
                                                            control of necrotic   first clinical
                                                            enteritis caused or   signs of disease;
                                                            complicated by        vary bacitracin
                                                            Clostridium spp. or   dosage based on the
                                                            other organisms       severity of
                                                            susceptible to        infection;
                                                            bacitracin.           administer
                                                                                  continuously for 5
                                                                                  to 7 days or as
                                                                                  long as clinical
                                                                                  signs persist, then
                                                                                  reduce bacitracin
                                                                                  to prevention level
                                                                                  (50 g/ton).
                                                                                  Bacitracin
                                                                                  methylenedisalicyla
                                                                                  te as provided by
                                                                                  No. 054771 in Sec.
                                                                                   510.600(c) of this
                                                                                  chapter.
(v) 113.5.........................  .....................  Broiler chickens:     Feed continuously as     054771
                                                            For prevention and    sole ration. Not to     058198
                                                            control of            be fed to laying
                                                            coccidiosis.          birds.
(vi) 113.5........................  Bacitracin             Broiler chickens: As  Feed continuously as     054771
                                     methylenedisalicylat   an aid in the         sole ration.
                                     e 4 to 50.             prevention and        Bacitracin
                                                            control of            methylenedisalicyla
                                                            coccidiosis; and      te as provided by
                                                            for increased rate    No. 054771 in Sec.
                                                            of weight gain and     510.600(c) of this
                                                            improved feed         chapter.
                                                            efficiency.
(vii) 113.5.......................  Bacitracin             Broiler chickens:     Feed continuously as     054771
                                     methylenedisalicylat   For prevention and    sole ration.
                                     e 50.                  control of            Bacitracin
                                                            coccidiosis; and as   methylenedisalicyla
                                                            an aid in the         te as provided by
                                                            prevention of         No. 054771 in Sec.
                                                            necrotic enteritis     510.600(c) of this
                                                            caused or             chapter.
                                                            complicated by
                                                            Clostridium spp. or
                                                            other organisms
                                                            susceptible to
                                                            bacitracin.
(viii) 113.5......................  Bacitracin             Broiler chickens:     Feed continuously as     054771
                                     methylenedisalicylat   For prevention and    sole ration. To
                                     e 100 to 200.          control of            control necrotic
                                                            coccidiosis; and as   enteritis, start
                                                            an aid in the         medication at first
                                                            control of necrotic   clinical signs of
                                                            enteritis caused or   disease; vary
                                                            complicated by        bacitracin dosage
                                                            Clostridium spp. or   based on the
                                                            other organisms       severity of
                                                            susceptible to        infection;
                                                            bacitracin.           administer
                                                                                  continuously for 5
                                                                                  to 7 days or as
                                                                                  long as clinical
                                                                                  signs persist, then
                                                                                  reduce bacitracin
                                                                                  to prevention level
                                                                                  (50 g/ton).
                                                                                 Bacitracin
                                                                                  methylenedisalicyla
                                                                                  te as provided by
                                                                                  No. 054771 in Sec.
                                                                                   510.600(c) of this
                                                                                  chapter.
(ix) 113.5........................  Bambermycins 1.......  Broiler chickens: As  Feed continuously as     016592
                                                            an aid in the         sole ration. Do not
                                                            prevention and        feed to chickens
                                                            control of            over 14 weeks of
                                                            coccidiosis; and      age. Bambermycins
                                                            for increased rate    as provided by No.
                                                            of weight gain and    016592 in Sec.
                                                            improved feed         510.600(c) of this
                                                            efficiency.           chapter.
----------------------------------------------------------------------------------------------------------------


[[Page 537]]

    (2) Turkeys--

----------------------------------------------------------------------------------------------------------------
                                     Combination in grams
       Zoalene in grams/ton                per ton          Indications for use       Limitations       Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 113.5 to 170.3................  .....................  Growing turkeys: For  Feed continuously as     054771
                                                            prevention and        sole ration. For        058198
                                                            control of            turkeys grown for
                                                            coccidiosis.          meat purposes only.
                                                                                  Not to be fed to
                                                                                  laying birds.
(ii) 113.5 to 170.3...............  Bacitracin             Growing turkeys: For  Feed continuously as     054771
                                     methylenedisalicylat   prevention and        sole ration until
                                     e 4 to 50.             control of            14 to 16 weeks of
                                                            coccidiosis; and      age. For turkeys
                                                            for increased rate    grown for meat
                                                            of weight gain and    purposes only. Do
                                                            improved feed         not feed to laying
                                                            efficiency.           birds.
----------------------------------------------------------------------------------------------------------------

    (3) Zoalene may also be used in combination with:
    (i)-(ii) [Reserved]
    (iii) Lincomycin as in Sec. 558.325.

[41 FR 11005, Mar. 15, 1976, as amended at 42 FR 18618, Apr. 8, 1977; 42 
FR 20817, Apr. 22, 1977; 42 FR 36995, July 19, 1977; 51 FR 7401, Mar. 3, 
1986; 52 FR 2686, Jan. 26, 1987; 55 FR 8461, Mar. 8, 1990; 57 FR 8403, 
Mar. 10, 1992; 57 FR 8578, Mar. 11, 1992; 61 FR 35957, July 9, 1996; 63 
FR 38750, July 20, 1998; 67 FR 6868, Feb. 14, 2002; 71 FR 16223, Mar. 
31, 2006; 71 FR 27958, May 15, 2006; 76 FR 17027, Mar. 28, 2011; 79 FR 
10983, Feb. 27, 2014; 79 FR 13546, Mar. 11, 2014; 81 FR 17610, Mar. 30, 
2016; 81 FR 95025, Dec. 27, 2016; 82 FR 21693, May 10, 2017; 86 FR 
14827, Mar. 19, 2021]

                           PART 564 [RESERVED]



PART 570_FOOD ADDITIVES--Table of Contents



                      Subpart A_General Provisions

Sec.
570.3 Definitions.
570.6 Opinion letters on food additive status.
570.13 Indirect food additives resulting from packaging materials prior 
          sanctioned for animal feed and pet food.
570.14 Indirect food additives resulting from packaging materials for 
          animal feed and pet food.
570.15 Adoption of regulation on initiative of Commissioner.
570.17 Exemption for investigational use and procedure for obtaining 
          authorization to market edible products from experimental 
          animals.
570.18 Tolerances for related food additives.
570.19 Pesticide chemicals in processed foods.

                     Subpart B_Food Additive Safety

570.20 General principles for evaluating the safety of food additives.
570.30 Eligibility for classification as generally recognized as safe 
          (GRAS).
570.35 Affirmation of generally recognized as safe (GRAS) status.
570.38 Determination of food additive status.

Subparts C-D [Reserved]

          Subpart E_Generally Recognized as Safe (GRAS) Notice

570.203 Definitions.
570.205 Opportunity to submit a GRAS notice.
570.210 How to send your GRAS notice to FDA.
570.215 Incorporation into a GRAS notice.
570.220 General requirements applicable to a GRAS notice.
570.225 Part 1 of a GRAS notice: Signed statements and certification.
570.230 Part 2 of a GRAS notice: Identity, method of manufacture, 
          specifications, and physical or technical effect.
570.235 Part 3 of a GRAS notice: Target animal and human exposures.
570.240 Part 4 of a GRAS notice: Self-limiting levels of use.
570.245 Part 5 of a GRAS notice: Experience based on common use in food 
          before 1958.
570.250 Part 6 of a GRAS notice: Narrative.
570.255 Part 7 of a GRAS notice: List of supporting data and information 
          in your GRAS notice.
570.260 Steps you may take before FDA responds to your GRAS notice.
570.265 What FDA will do with a GRAS notice.
570.275 Public disclosure of a GRAS notice.
570.280 Submission of a supplement.

    Authority: 21 U.S.C. 321, 341, 342, 346a, 348, 371.

    Source: 41 FR 38644, Sept. 10, 1976, unless otherwise noted.



                      Subpart A_General Provisions



Sec. 570.3  Definitions.

    (a) Secretary means the Secretary of Health and Human Services.

[[Page 538]]

    (b) Department means the Department of Health and Human Services.
    (c) Commissioner means the Commissioner of Food and Drugs.
    (d) As used in this part, the term act means the Federal Food, Drug, 
and Cosmetic Act approved June 25, 1936 (52 Stat. 1040 et seq., as 
amended; 21 U.S.C. 301-392).
    (e) Food additives includes all substances not exempted by section 
201(s) of the act, the intended use of which results or may reasonably 
be expected to result, directly or indirectly, either in their becoming 
a component of food or otherwise affecting the characteristics of food. 
A material used in the production of containers and packages is subject 
to the definition if it may reasonably be expected to become a 
component, or to affect the characteristics, directly or indirectly, of 
food packed in the container. Affecting the characteristics of food does 
not include such physical effects, as protecting contents of packages, 
preserving shape, and preventing moisture loss. If there is no migration 
of a packaging component from the package to the food, it does not 
become a component of the food and thus is not a food additive. A 
substance that does not become a component of food, but that is used, 
for example, in preparing an ingredient of the food to give a different 
flavor, texture, or other characteristic in the food, may be a food 
additive.
    (f) Common use in food means a substantial history of consumption of 
a substance by a significant number of animals of the species to which 
the substance is intended to be fed (and, for food-producing animals fed 
with such substance, also means a substantial history of consumption by 
humans consuming human foods derived from those food-producing animals), 
prior to January 1, 1958.
    (g) The word substance in the definition of the term food additive 
includes a food or feed or a component of a food or feed consisting of 
one or more ingredients.
    (h) Scientific procedures include the application of scientific data 
(including, as appropriate, data from human, animal, analytical, or 
other scientific studies), information, and methods, whether published 
or unpublished, as well as the application of scientific principles, 
appropriate to establish the safety of a substance under the conditions 
of its intended use.
    (i) Safe or safety means that there is a reasonable certainty in the 
minds of competent scientists that the substance is not harmful under 
the conditions of its intended use. It is impossible in the present 
state of scientific knowledge to establish with complete certainty the 
absolute harmlessness of the use of any substance. Safety may be 
determined by scientific procedures or by general recognition of safety. 
In determining safety, the following factors shall be considered:
    (1) The probable consumption of the substance and of any substance 
formed in or on food because of its use;
    (2) The cumulative effect of the substance in the diet, taking into 
account any chemically or pharmacologically related substance or 
substances in such diet;
    (3) Safety factors which, in the opinion of experts qualified by 
scientific training and experience to evaluate the safety of food and 
food ingredients, are generally recognized as appropriate.
    (j) The term nonperishable processed food means any processed food 
not subject to rapid decay or deterioration that would render it unfit 
for consumption. Not included are hermetically sealed foods and other 
processed foods requiring refrigeration.
    (k) General recognition of safety shall be in accordance with Sec. 
570.30.
    (l) Prior sanction means an explicit approval granted with respect 
to use of a substance in food prior to September 6, 1958, by the Food 
Drug and Administration or the United States Department of Agriculture 
pursuant to the Federal Food, Drug, and Cosmetic Act, the Poultry 
Products Inspection Act, or the Meat Inspection Act.
    (m) Food includes human food, substances migrating to food from 
food-contact articles, pet food, and animal feed.
    (n) Food-producing animal means an animal used to produce human 
food.

[41 FR 38644, Sept. 10, 1976, as amended at 42 FR 55206, Oct. 14, 1977; 
81 FR 55051, Aug. 17, 2016]

[[Page 539]]



Sec. 570.6  Opinion letters on food additive status.

    (a) Over the years the Food and Drug Administration has given 
informal written opinions to inquirers as to the safety of articles 
intended for use as components of, or in contact with, food. Prior to 
the enactment of the Food Additives Amendment of 1958 (Pub. L. 85-929, 
Sept. 6, 1958), these opinions were given pursuant to section 402(a)(1) 
of the Federal Food, Drug, and Cosmetic Act, which reads in part: ``A 
food shall be deemed to be adulterated if it bears or contains any 
poisonous or deleterious substance which may render it injurious to 
health''.
    (b) Since enactment of the Food Additives Amendment, the Food and 
Drug Administration has advised such inquirers that an article:
    (1) Is a food additive within the meaning of section 201(s) of the 
act; or
    (2) Is generally recognized as safe (GRAS); or
    (3) Has prior sanction or approval under that amendment; or
    (4) Is not a food additive under the conditions of intended use.
    (c) In the interest of the public health, such articles which have 
been considered in the past by the Food and Drug Administration to be 
safe under the provisions of section 402(a)(1), or to be generally 
recognized as safe for their intended use, or to have prior sanction or 
approval, or not to be food additives under the conditions of intended 
use, must be reexamined in the light of current scientific information 
and current principles for evaluating the safety of food additives if 
their use is to be continued.
    (d) Because of the time span involved, copies of many of the letters 
in which the Food and Drug Administration has expressed an informal 
opinion concerning the status of such articles may no longer be in the 
file of the Food and Drug Administration. In the absence of information 
concerning the names and uses made of all the articles referred to in 
such letters, their safety of use cannot be reexamined. For this reason 
all food additive status opinions of the kind described in paragraph (c) 
of this section given by the Food and Drug Administration are hereby 
revoked.
    (e) The prior opinions of the kind described in paragraph (c) of 
this section will be replaced by qualified and current opinions if the 
recipient of each such letter forwards a copy of each to the Department 
of Health and Human Services, Food and Drug Administration, Center for 
Veterinary Medicine, Office of Surveillance and Compliance (HFV-200), 
7500 Standish Pl., Rockville, MD 20855, along with a copy of his letter 
of inquiry, on or before July 23, 1970.
    (f) This section does not apply to food additive status opinion 
letters pertaining to articles that were considered by the Food and Drug 
Administration to be food additives nor to articles included in 
regulations in this Subchapter E if the articles are used in accordance 
with the requirements of such regulations.

[41 FR 38644, Sept. 10, 1976, as amended at 54 FR 18281, Apr. 28, 1989; 
57 FR 6476, Feb. 25, 1992]



Sec. 570.13  Indirect food additives resulting from packaging
materials prior sanctioned for animal feed and pet food.

    Regulations providing for the use of food packaging materials as 
prior sanctioned in part 181 of this chapter are incorporated in 
Subchapter E as applicable to packaging materials used for animal feed 
and pet food.

[42 FR 14091, Mar. 15, 1977]



Sec. 570.14  Indirect food additives resulting from packaging 
materials for animal feed and pet food.

    Regulations providing for the use of food packaging materials in 
parts 174 through 179 of this chapter are incorporated in Subchapter E 
as applicable to packaging materials used for animal feed and pet food.

[42 FR 14091, Mar. 15, 1977]



Sec. 570.15  Adoption of regulation on initiative of Commissioner.

    (a) The Commissioner upon his own initiative may propose the 
issuance of a regulation prescribing, with respect to any particular use 
of a food additive,

[[Page 540]]

the conditions under which such additive may be safely used. Notice of 
such proposal shall be published in the Federal Register and shall state 
the reasons for the proposal.
    (b) Action upon a proposal made by the Commissioner shall proceed as 
provided in part 10 of this chapter.

[41 FR 38644, Sept. 10, 1976, as amended at 42 FR 4717, Jan. 25, 1977; 
42 FR 15675, Mar. 22, 1977]



Sec. 570.17  Exemption for investigational use and procedure for
obtaining authorization to market edible products from experimental
animals.

    A food additive or food containing a food additive intended for 
investigational use by qualified experts shall be exempt from the 
requirements of section 409 of the act under the following conditions:
    (a) If intended for investigational use in vitro or in laboratory 
research animals, it bears a label which states prominently, in addition 
to the other information required by the act, the warning:

    Caution. Contains a new food additive for investigational use only 
in laboratory research animals or for tests in vitro. Not for use in 
humans.

    (b) If intended for use in animals other than laboratory research 
animals and if the edible products of the animals are to be marketed as 
food, permission for the marketing of the edible products as food has 
been requested by the sponsor, and authorization has been granted by the 
Food and Drug Administration in accordance with Sec. 511.1 of this 
chapter or by the Department of Agriculture in accordance with 9 CFR 
309.17, and it bears a label which states prominently, in addition to 
the other information required by the act, the warning:

    Caution. Contains a new food additive for use only in 
investigational animals. Not for use in humans.
    Edible products of investigational animals are not to be used for 
food unless authorization has been granted by the U.S. Food and Drug 
Administration or by the U.S. Department of Agriculture.

    (c) If intended for nonclinical laboratory studies in food-producing 
animals, the study is conducted in compliance with the regulations set 
forth in part 58 of this chapter.

[41 FR 38644, Sept. 10, 1976, as amended at 43 FR 60023, Dec. 22, 1978]



Sec. 570.18  Tolerances for related food additives.

    (a) Food additives that cause similar or related pharmacological 
effects will be regarded as a class, and in the absence of evidence to 
the contrary, as having additive toxic effects and will be considered as 
related food additives.
    (b) Tolerances established for such related food additives may limit 
the amount of a common component that may be present, or may limit the 
amount of biological activity (such as cholinesterase inhibition) that 
may be present or may limit the total amount of related food additives 
that may be present.
    (c) Where food additives from two or more chemicals in the same 
class are present in or on a food, the tolerance for the total of such 
additives shall be the same as that for the additive having the lowest 
numerical tolerance in this class, unless there are available methods 
that permit quantitative determination of the amount of each food 
additive present or unless it is shown that a higher tolerance is 
reasonably required for the combined additives to accomplish the 
physical or technical effect for which such combined additives are 
intended and that the higher tolerance will be safe.
    (d) Where residues from two or more additives in the same class are 
present in or on a food and there are available methods that permit 
quantitative determination of each residue, the quantity of combined 
residues that are within the tolerance may be determined as follows:
    (1) Determine the quantity of each residue present.
    (2) Divide the quantity of each residue by the tolerance that would 
apply if it occurred alone, and multiply by 100 to determine the 
percentage of the permitted amount of residue present.
    (3) Add the percentages so obtained for all residues present.
    (4) The sum of the percentages shall not exceed 100 percent.

[[Page 541]]



Sec. 570.19  Pesticide chemicals in processed foods.

    When pesticide chemical residues occur in processed foods due to the 
use of raw agricultural commodities that bore or contained a pesticide 
chemical in conformity with an exemption granted or a tolerance 
prescribed under section 408 of the act, the processed food will not be 
regarded as adulterated so long as good manufacturing practice has been 
followed in removing any residue from the raw agricultural commodity in 
the processing (such as by peeling or washing) and so long as the 
concentration of the residue in the processed food when ready to eat is 
not greater than the tolerance prescribed for the raw agricultural 
commodity. But when the concentration of residue in the processed food 
when ready to eat is higher than the tolerance prescribed for the raw 
agricultural commodity, the processed food is adulterated unless the 
higher concentration is permitted by a tolerance obtained under section 
409 of the act. For example, if fruit bearing a residue of 7 parts per 
million of DDT permitted on the raw agricultural commodity is dried and 
a residue in excess of 7 parts per million of DDT results on the dried 
fruit, the dehydrated fruit is adulterated unless the higher tolerance 
for DDT is authorized by the regulations in this part. Food that is 
itself ready to eat, and which contains a higher residue than allowed 
for the raw agricultural commodity, may not be legalized by blending or 
mixing with other foods to reduce the residue in the mixed food below 
the tolerance prescribed for the raw agricultural commodity.



                     Subpart B_Food Additive Safety



Sec. 570.20  General principles for evaluating the safety of food
additives.

    (a) In reaching a decision on any petition filed under section 409 
of the act, the Commissioner will give full consideration to the 
specific biological properties of the compound and the adequacy of the 
methods employed to demonstrate safety for the proposed use, and the 
Commissioner will be guided by the principles and procedures for 
establishing the safety of food additives stated in current publications 
of the National Academy of Sciences-National Research Council. A 
petition will not be denied, however, by reason of the petitioner's 
having followed procedures other than those outlined in the publications 
of the National Academy of Sciences-National Research Council if, from 
available evidence, the Commissioner finds that the procedures used give 
results as reliable as, or more reliable than, those reasonably to be 
expected from the use of the outlined procedures. In reaching a 
decision, the Commissioner will give due weight to the anticipated 
levels and patterns of consumption of the additive specified or 
reasonably inferable. For the purposes of this section, the principles 
for evaluating safety of additives set forth in the above-mentioned 
publications will apply to any substance that may properly be classified 
as a food additive as defined in section 201(s) of the act.
    (b) Upon written request describing the proposed use of an additive 
and the proposed experiments to determine its safety, the Commissioner 
will advise a person who wishes to establish the safety of a food 
additive whether he believes the experiments planned will yield data 
adequate for an evaluation of the safety of the additive.



Sec. 570.30  Eligibility for classification as generally recognized
as safe (GRAS).

    (a) General recognition of safety may be based only on the views of 
experts qualified by scientific training and experience to evaluate the 
safety of substances directly or indirectly added to food. The basis of 
such views may be either (1) scientific procedures or (2) in the case of 
a substance used in food prior to January 1, 1958, through experience 
based on common use in food. General recognition of safety requires 
common knowledge throughout the scientific community knowledgeable about 
the safety of substances directly or indirectly added to food that there 
is reasonable certainty that the substance is not harmful to either the 
target animal or to humans consuming human food derived from food-
producing animals under the conditions of its intended use (see Sec. 
570.3(i)).

[[Page 542]]

    (b) General recognition of safety based upon scientific procedures 
shall require the same quantity and quality of scientific evidence as is 
required to obtain approval of a food additive. General recognition of 
safety through scientific procedures shall address safety for both the 
target animal and for humans consuming human food derived from food-
producing animals and shall be based upon the application of generally 
available and accepted scientific data, information, or methods, which 
ordinarily are published, as well as the application of scientific 
principles, and may be corroborated by the application of unpublished 
scientific data, information, or methods.
    (c)(1) General recognition of safety through experience based on 
common use in food prior to January 1, 1958, shall address safety for 
both the target animal and for humans consuming human food derived from 
food-producing animals and may be achieved without the quantity or 
quality of scientific procedures required for approval of a food 
additive. General recognition of safety through experience based on 
common use in food prior to January 1, 1958, shall be based solely on 
food use of the substance in the same animal species prior to January 1, 
1958, and shall ordinarily be based upon generally available data and 
information. An ingredient not in common use in food prior to January 1, 
1958, may achieve general recognition of safety only through scientific 
procedures.
    (2) A substance used in food prior to January 1, 1958, may be 
generally recognized as safe through experience based on its common use 
in food when that use occurred exclusively or primarily outside of the 
United States if the information about the experience establishes that 
the substance is safe under the conditions of its intended use within 
the meaning of section 201(u) of the Federal Food, Drug, and Cosmetic 
Act (see also Sec. 570.3(i)) for both the target animal and for humans 
consuming human food derived from food-producing animals. Common use in 
food prior to January 1, 1958, that occurred outside of the United 
States shall be documented by published or other information and shall 
be corroborated by information from a second, independent source that 
confirms the history and circumstances of use of the substance. The 
information used to document and to corroborate the history and 
circumstances of use of the substance must be generally available; that 
is, it must be widely available in the country in which the history of 
use has occurred and readily available to interested qualified experts 
in the United States. A person who concludes that a use of a substance 
is GRAS through experience based on its common use in food outside of 
the United States should notify FDA of that view in accordance with 
subpart E of this part.
    (d) The food ingredients listed as GRAS in part 582 of this chapter 
or affirmed as GRAS in part 584 of this chapter do not include all 
substances that are generally recognized as safe for their intended use 
in food. Because of the large number of substances the intended use of 
which results or may reasonably be expected to result, directly or 
indirectly, in their becoming a component or otherwise affecting the 
characteristics of food, it is impracticable to list all such substances 
that are GRAS. A food ingredient of natural biological origin that has 
been widely consumed for its nutrient properties in the United States 
prior to January 1, 1958, without known detrimental effects, which is 
subject only to conventional processing as practiced prior to January 1, 
1958, and for which no known safety hazard exists, will ordinarily be 
regarded as GRAS without specific inclusion in part 582 or part 584 of 
this chapter.
    (e) A food ingredient that is not GRAS or subject to a prior 
sanction requires a food additive regulation promulgated under section 
409 of the act before it may be directly or indirectly added to food.
    (f) A food ingredient that is listed as GRAS in part 582 of this 
chapter shall be regarded as GRAS only if, in addition to all the 
requirements in the applicable regulation, it also meets all of the 
following requirements:
    (1) It complies with any applicable specifications, or in the 
absence of such specifications, shall be of a purity suitable for its 
intended use.

[[Page 543]]

    (2) It performs an appropriate function in the food or food-contact 
article in which it is used.
    (3) It is used at a level no higher than necessary to achieve its 
intended purpose in that food or, if used as a component of a food-
contact article, at a level no higher than necessary to achieve its 
intended purpose in that article.
    (g) New information may at any time require reconsideration of the 
GRAS status of a food ingredient. Any change in status shall be 
accomplished pursuant to Sec. 570.38.
    (h) If a substance is affirmed as GRAS pursuant to Sec. 570.35 and 
listed in a regulation with no limitation other than good manufacturing 
practice, it shall be regarded as GRAS if its conditions of use are not 
significantly different from those reported in the regulation as the 
basis on which the GRAS status of the substance was affirmed. If the 
conditions of use are significantly different, such use of the substance 
may not be GRAS. In such case a manufacturer may not rely on the 
regulation as authorizing the use but must independently establish that 
the use is GRAS or must use the substance in accordance with a food 
additive regulation.
    (i) If an ingredient is affirmed as GRAS pursuant to Sec. 570.35 
and listed in a regulation with specific limitation(s), it may be used 
in food only within such limitation(s) (including the category of 
food(s), the functional use(s) of the ingredient, and the level(s) of 
use). Any use of such an ingredient not in full compliance with each 
such established limitation shall require a food additive regulation.
    (j) Pursuant to Sec. 570.35, a food ingredient may be affirmed as 
GRAS and listed in a regulation for a specific use(s) without a general 
evaluation of use of the ingredient. In addition to the use(s) specified 
in the regulation, other uses of such an ingredient may also be GRAS. 
Any affirmation of GRAS status for a specific use(s), without a general 
evaluation of use of the ingredient, is subject to reconsideration upon 
such evaluation.

[42 FR 55206, Oct. 14, 1977, as amended at 81 FR 55052, Aug. 17, 2016]



Sec. 570.35  Affirmation of generally recognized as safe (GRAS)
status.

    (a) The Commissioner, on his own initiative, may affirm that a 
substance that directly or indirectly becomes a component of food is 
GRAS under the conditions of its intended use.
    (b)(1) If the Commissioner proposes on his own initiative that a 
substance is entitled to affirmation as GRAS under the conditions of its 
intended use, he will place all of the data and information on which he 
relies on public file in the office of the Division of Dockets 
Management and will publish in the Federal Register a notice giving the 
name of the substance, its proposed uses, and any limitations proposed 
for purposes other than safety.
    (2) The Federal Register notice will allow a period of 60 days 
during which any interested person may review the data and information 
and/or file comments with the Division of Dockets Management. Copies of 
all comments received shall be made available for examination in the 
Division of Dockets Management's office.
    (3) The Commissioner will evaluate all comments received. If he 
concludes that there is convincing evidence that the substance is GRAS 
under the conditions of its intended use as described in Sec. 570.30, 
he will publish a notice in the Federal Register listing the GRAS 
conditions of use in this subchapter E.
    (4) If, after evaluation of the comments, the Commissioner concludes 
that there is a lack of convincing evidence that the substance is GRAS 
under the conditions of its intended use and that it should be 
considered a food additive subject to section 409 of the Federal Food, 
Drug, and Cosmetic Act, he shall publish a notice thereof in the Federal 
Register in accordance with Sec. 570.38.

[41 FR 38644, Sept. 10, 1976, as amended at 42 FR 4717, Jan. 25, 1977; 
42 FR 15675, Mar. 22, 1977; 42 FR 55207, Oct. 10, 1977; 50 FR 7517, Feb. 
22, 1985; 50 FR 16668, Apr. 26, 1985; 54 FR 18281, Apr. 28, 1989; 62 FR 
40600, July 29, 1997; 81 FR 55052, Aug. 17, 2016]



Sec. 570.38  Determination of food additive status.

    (a) The Commissioner may, in accordance with Sec. 570.35(b)(4), 
publish a

[[Page 544]]

notice in the Federal Register determining that a substance is not GRAS 
under the conditions of its intended use and is a food additive subject 
to section 409 of the Federal Food, Drug, and Cosmetic Act.
    (b)(1) The Commissioner, on his own initiative or on the petition of 
any interested person, pursuant to part 10 of this chapter, may issue a 
notice in the Federal Register proposing to determine that a substance 
is not GRAS and is a food additive subject to section 409 of the act. 
Any petition shall include all relevant data and information of the type 
described in Sec. 571.130(b) of this chapter. The Commissioner will 
place all of the data and information on which he relies on public file 
in the Division of Dockets Management and will include in the Federal 
Register notice the name of the substance, its known uses, and a summary 
of the basis for the determination.
    (2) The Federal Register notice will allow a period of 60 days 
during which any interested person may review the data and information 
and/or file comments with the Division of Dockets Management. Copies of 
all comments shall be made available for examination in the Division of 
Dockets Management.
    (3) The Commissioner will evaluate all comments received. If he 
concludes that there is a lack of convincing evidence that the substance 
is GRAS or is otherwise exempt from the definition of a food additive in 
section 201(s) of the act, he will publish a notice thereof in the 
Federal Register. If he concludes that there is convincing evidence that 
the substance is GRAS, he will publish an order in the Federal Register 
listing the substance in this subchapter E as GRAS.
    (c) A Federal Register notice determining that a substance is a food 
additive shall provide for the use of the additive in food or food-
contact surfaces as follows:
    (1) It may promulgate a food additive regulation governing use of 
the additive.
    (2) It may promulgate an interim food additive regulation governing 
use of the additive.
    (3) It may require discontinuation of the use of the additive.
    (4) It may adopt any combination of the above three approaches for 
different uses or levels of use of the additive.
    (d) If the Commissioner of Food and Drugs is aware of any prior 
sanction for use of the substance, he will concurrently propose a 
separate regulation covering such use of the ingredient under this 
subchapter E. If the Commissioner is unaware of any such applicable 
prior sanction, the proposed regulation will so state and will require 
any person who intends to assert or rely on such sanction to submit 
proof of its existence. Any regulation promulgated pursuant to this 
section constitutes a determination that excluded uses would result in 
adulteration of the food in violation of section 402 of the act, and the 
failure of any person to come forward with proof of such an applicable 
prior sanction in response to the proposal will constitute a waiver of 
the right to assert or rely on such sanction at any later time. The 
notice will also constitute a proposal to establish a regulation under 
this subchapter E., incorporating the same provisions, in the event that 
such a regulation is determined to be appropriate as a result of 
submission of proof of such an applicable prior sanction in response to 
the proposal.

[41 FR 38644, Sept. 10, 1976, as amended at 42 FR 4717, Jan. 25, 1977; 
42 FR 15675, Mar. 22, 1977; 42 FR 55207, Oct. 14, 1977; 54 FR 18281, 
Apr. 28, 1989; 81 FR 55052, Aug. 17, 2016]

Subparts C-D [Reserved]



          Subpart E_Generally Recognized as Safe (GRAS) Notice

    Source: 81 FR 55052, Aug. 17, 2016, unless otherwise noted.



Sec. 570.203  Definitions.

    The definitions and interpretations of terms in Sec. 570.3 apply to 
such terms when used in this subpart. The following definitions also 
apply:
    Amendment means any data and information that you submit regarding a 
filed GRAS notice before we respond to your notice by letter in 
accordance with Sec. 570.265(b)(1) or cease to evaluate

[[Page 545]]

your notice in accordance with Sec. 570.265(b)(3).
    GRAS means generally recognized as safe.
    GRAS notice means a submission that informs us of your view that a 
substance is not subject to the premarket approval requirements of the 
Federal Food, Drug, and Cosmetic Act based on your conclusion that the 
substance is GRAS under the conditions of its intended use in accordance 
with Sec. 570.30.
    Notified substance means the substance that is the subject of your 
GRAS notice.
    Notifier means the person (e.g., an individual, partnership, 
corporation, association, or other legal entity) who is responsible for 
the GRAS notice, even if another person (such as an attorney, agent, or 
qualified expert) prepares or submits the notice or provides an opinion 
about the basis for a conclusion of GRAS status.
    Qualified expert means an individual who is qualified by scientific 
training and experience to evaluate the safety of substances under the 
conditions of their intended use in animal food.
    Supplement means any data and information that you submit regarding 
a filed GRAS notice after we respond to your notice by letter in 
accordance with Sec. 570.265(b)(1) or cease to evaluate your notice in 
accordance with Sec. 570.265(b)(3).
    We, our, and us refer to the United States Food and Drug 
Administration (FDA).
    You and your refer to a notifier.



Sec. 570.205  Opportunity to submit a GRAS notice.

    Any person may notify FDA of a view that a substance is not subject 
to the premarket approval requirements of section 409 of the Federal 
Food, Drug, and Cosmetic Act based on that person's conclusion that the 
substance is GRAS under the conditions of its intended use.



Sec. 570.210  How to send your GRAS notice to FDA.

    (a) Send your GRAS notice to the Division of Animal Feeds (HFV-220), 
Center for Veterinary Medicine, Food and Drug Administration, 7519 
Standish Pl., Rockville, MD 20855.
    (b) When you submit your GRAS notice, you may do so either in an 
electronic format that is accessible for our evaluation or on paper. If 
you send your GRAS notice on paper, a single paper copy is sufficient.



Sec. 570.215  Incorporation into a GRAS notice.

    You may incorporate into your GRAS notice either specifically 
identified data and information that you previously submitted to the 
Center for Veterinary Medicine (CVM), or specifically identified 
publicly available data and information submitted by another party, when 
such data and information remain in CVM's records, such as data and 
information contained in a previous GRAS notice or a food additive 
petition.



Sec. 570.220  General requirements applicable to a GRAS notice.

    (a) A GRAS notice has seven parts as required by Sec. Sec. 570.225 
through 570.255. You must submit the data and information specified in 
each of these parts on separate pages or sets of pages.
    (b) You must include each of the seven parts in your GRAS notice. If 
you do not include a part, you must include with your GRAS notice an 
explanation of why that part does not apply to your GRAS notice.



Sec. 570.225  Part 1 of a GRAS notice: Signed statements and 
certification.

    (a) Part 1 of your GRAS notice must be dated and signed by a 
responsible official of your organization, or by your attorney or agent.
    (b) Except as required by paragraph (c)(8) of this section, you must 
not include any information that is trade secret or confidential 
commercial information in Part 1 of your GRAS notice.
    (c) In Part 1 of your GRAS notice, you must:
    (1) Inform us that you are submitting a GRAS notice in accordance 
with this subpart;
    (2) Provide the name and address of your organization;
    (3) Provide the name of the notified substance, using an 
appropriately descriptive term;

[[Page 546]]

    (4) Describe the intended conditions of use of the notified 
substance, including stating whether the substance will be added to food 
(including drinking water) for animals in which the substance will be 
used; identifying the foods to which it will be added, the levels of use 
in such foods, and the animal species for which these foods are intended 
(including, when appropriate, a description of a subpopulation expected 
to consume the notified substance); and the purposes for which the 
substance will be used;
    (5) Inform us of the statutory basis for your conclusion of GRAS 
status (i.e., through scientific procedures in accordance with Sec. 
570.30(a) and (b) or through experience based on common use in animal 
food in accordance with Sec. 570.30(a) and (c));
    (6) State your view that the notified substance is not subject to 
the premarket approval requirements of the Federal Food, Drug, and 
Cosmetic Act based on your conclusion that the notified substance is 
GRAS under the conditions of its intended use;
    (7) State that, if we ask to see the data and information that are 
the basis for your conclusion of GRAS status, either during or after our 
evaluation of your notice, you will:
    (i) Agree to make the data and information available to us; and
    (ii) Agree to both of the following procedures for making the data 
and information available to us:
    (A) Upon our request, you will allow us to review and copy the data 
and information during customary business hours at the address you 
specify for where these data and information will be available to us; 
and
    (B) Upon our request, you will provide us with a complete copy of 
the data and information either in an electronic format that is 
accessible for our evaluation or on paper;
    (8) State your view as to whether any of the data and information in 
Parts 2 through 7 of your GRAS notice are exempt from disclosure under 
the Freedom of Information Act, 5 U.S.C. 552 (e.g., as trade secret or 
as commercial or financial information that is privileged or 
confidential);
    (9) Certify that, to the best of your knowledge, the GRAS notice is 
a complete, representative, and balanced submission that includes 
unfavorable information, as well as favorable information, known to you 
and pertinent to the evaluation of the safety and GRAS status of the use 
of the substance; and
    (10) State both the name and the position or title of the person who 
signs the GRAS notice.



Sec. 570.230  Part 2 of a GRAS notice: Identity, method of 
manufacture, specifications, and physical or technical effect.

    In Part 2 of your GRAS notice, you must include:
    (a) Scientific data and information that identifies the notified 
substance.
    (1) Examples of appropriate data and information include the 
chemical name, applicable registry numbers (such as a Chemical Abstracts 
Service (CAS) registry number or an Enzyme Commission (EC) number), 
empirical formula, structural formula, quantitative composition, and 
characteristic properties.
    (2) When the source of a notified substance is a biological 
material, you must include data and information sufficient to identify:
    (i) The taxonomic source (e.g., genus, species), including as 
applicable data and information at the sub-species level (e.g., variety, 
strain);
    (ii) The part of any plant or animal used as the source; and
    (iii) Any known toxicants that could be in the source;
    (b) A description of the method of manufacture of the notified 
substance in sufficient detail to evaluate the safety of the notified 
substance as manufactured;
    (c) Specifications for material that is of appropriate grade for use 
in animal food; and
    (d) When necessary to demonstrate safety, relevant data and 
information bearing on the physical or other technical effect the 
notified substance is intended to produce, including the quantity of the 
notified substance required to produce such effect.



Sec. 570.235  Part 3 of a GRAS notice: Target animal and human 
exposures.

    In part 3 of your GRAS notice, you must provide data and information 
about exposure to the target animal

[[Page 547]]

and to humans consuming human food derived from food-producing animals, 
regardless of whether your conclusion of GRAS status is through 
scientific procedures or through experience based on common use in food, 
as follows:
    (a) For exposure to the target animal, you must provide:
    (1) The amount of the notified substance that different target 
animal species are likely to consume in the animal food (including 
drinking water) as part of the animal's total diet, including the 
intended use and all other sources in the total diet; and
    (2) When applicable, the amount of any other substance that is 
expected to be formed in or on food because of the use of the notified 
substance (e.g., hydrolytic products or reaction products);
    (3) When applicable, the amount of any other substance that is 
present with the notified substance either naturally or due to its 
manufacture (e.g., contaminants or by-products);
    (4) The data and information you rely on to establish the amount of 
the notified substance and the amounts of any other substance in 
accordance with paragraphs (a)(1) through (a)(3) of this section that 
different target animal species are likely to consume in the animal food 
(including drinking water) as part of the animal's total diet; and
    (b) When the intended use is in food for food-producing animals, you 
must provide:
    (1) The potential quantities of any residues that humans may be 
exposed to in edible animal tissues, including:
    (i) Residues of the notified substance;
    (ii) Residues of any other substance that is expected to be formed 
in or on the animal food because of the use of the notified substance; 
and
    (iii) Residues from any other substance that is present with the 
notified substance whether naturally, due to its manufacture (e.g., 
contaminants or by-products), or produced as a metabolite in edible 
animal tissues when the notified substance is consumed by a food-
producing animal; and
    (2) The data and information you rely on to establish, in accordance 
with paragraph (b)(1) of this section, the potential quantities of any 
residues that humans may be exposed to in edible animal tissues.



Sec. 570.240  Part 4 of a GRAS notice: Self-limiting levels of use.

    In circumstances where the amount of the notified substance that can 
be added to animal food is limited because animal food containing levels 
of the notified substance above a particular level would become 
unpalatable or technologically impractical, in Part 4 of your GRAS 
notice you must include data and information on such self-limiting 
levels of use.



Sec. 570.245  Part 5 of a GRAS notice: Experience based on common 
use in food before 1958.

    If the statutory basis for your conclusion of GRAS status is through 
experience based on common use in animal food, in Part 5 of your GRAS 
notice you must include evidence of a substantial history of consumption 
of the notified substance for food use by a significant number of 
animals of the species to which the substance is intended to be fed 
prior to January 1, 1958, and evidence of a substantial history of 
consumption by humans consuming human foods derived from food-producing 
animals prior to January 1, 1958.



Sec. 570.250  Part 6 of a GRAS notice: Narrative.

    In Part 6 of your GRAS notice, you must include a narrative that 
provides the basis for your conclusion of GRAS status, in which:
    (a)(1) You must explain why the data and information in your notice 
provide a basis for your view that the notified substance is safe under 
the conditions of its intended use for both the target animal and for 
humans consuming human food derived from food-producing animals. In your 
explanation, you must address the safety of the notified substance, 
considering all animal food (including drinking water) as part of the 
animal's total diet, taking into account any chemically or 
pharmacologically related substances in such diet. In your explanation, 
you must also address the safety of the notified substance in regard to 
human exposure, considering all dietary sources

[[Page 548]]

and taking into account any chemically or pharmacologically related 
substances;
    (2) In your explanation, you must identify what specific data and 
information that you discuss in accordance with paragraph (a)(1) of this 
section are generally available, and what specific data and information 
that you discuss in accordance with paragraph (a)(1) of this section are 
not generally available, by providing citations to the list of data and 
information that you include in Part 7 of your GRAS notice in accordance 
with Sec. 570.255;
    (b) You must explain how the generally available data and 
information that you rely on to establish safety in accordance with 
paragraph (a) of this section provide a basis for your conclusion that 
the notified substance is generally recognized, among qualified experts, 
to be safe under the conditions of its intended use for both the target 
animal and for humans consuming human food derived from food-producing 
animals;
    (c) You must either:
    (1) Identify, discuss, and place in context, data and information 
that are, or may appear to be, inconsistent with your conclusion of GRAS 
status, regardless of whether those data and information are generally 
available; or
    (2) State that you have reviewed the available data and information 
and are not aware of any data and information that are, or may appear to 
be, inconsistent with your conclusion of GRAS status;
    (d) If you view any of the data and information in your notice as 
exempt from disclosure under the Freedom of Information Act, you must 
identify the specific data and information; and
    (e) For non-public, safety-related data and information considered 
in reaching a conclusion of GRAS status, you must explain how there 
could be a basis for a conclusion of GRAS status if qualified experts do 
not have access to such data and information.



Sec. 570.255  Part 7 of a GRAS notice: List of supporting data and 
information in your GRAS notice.

    (a) In part 7 of your GRAS notice, you must include a list of all of 
the data and information that you discuss in Part 6 of your GRAS notice 
to provide a basis for your view that the notified substance is safe 
under the conditions of its intended use as described in accordance with 
Sec. 570.250(a)(1).
    (b) You must specify which data and information that you list in 
accordance with paragraph (a) of this section are generally available, 
and which data and information are not generally available.



Sec. 570.260  Steps you may take before FDA responds to your GRAS
notice.

    (a) You may submit a timely amendment to your filed GRAS notice, to 
update your GRAS notice or in response to a question from us, before we 
respond to your notice by letter in accordance with Sec. 570.265(b)(1) 
or cease to evaluate your notice in accordance with Sec. 570.265(b)(3).
    (b) At any time before we respond to your notice by letter in 
accordance with Sec. 570.265(b)(1), you may request in writing that we 
cease to evaluate your GRAS notice. Your request does not preclude you 
from submitting a future GRAS notice in accordance with this subpart 
with respect to the notified substance.



Sec. 570.265  What FDA will do with a GRAS notice.

    (a)(1) We will conduct an initial evaluation of your submission to 
determine whether to file it as a GRAS notice for evaluation of your 
view that the notified substance is GRAS under the conditions of its 
intended use.
    (2) If we file your submission as a GRAS notice, we will send you a 
letter that informs you of the date of filing.
    (3) If we do not file your submission as a GRAS notice, we will send 
you a letter that informs you of that fact and provide our reasons for 
not filing the submission as a GRAS notice.
    (4) We will consider any timely amendment that you submit to a filed 
GRAS notice, to update your GRAS notice or in response to a question 
from us, before we respond to you by letter in accordance with paragraph 
(b)(1) of this section, if we deem that doing so is feasible within the 
timeframes established in paragraph (b) of this section. If we deem that 
considering your amendment is not feasible within the

[[Page 549]]

timeframes established in paragraph (b) of this section or if we have 
granted your request to cease to evaluate your notice, we will inform 
you that we are not considering your amendment.
    (b)(1) Within 180 days of filing, we will respond to you by letter 
based on our evaluation of your notice. We may extend the 180 day 
timeframe by 90 days on an as needed basis.
    (2) If we extend the timeframe, we will inform you in writing of the 
extension as soon as practicable but no later than within 180 days of 
filing.
    (3) If you ask us to cease to evaluate your GRAS notice in 
accordance with Sec. 570.260(b), we will send you a letter informing 
you of our decision regarding your request.
    (c) If circumstances warrant, we will send you a subsequent letter 
about the notice.



Sec. 570.275  Public disclosure of a GRAS notice.

    (a) The data and information in a GRAS notice (including data and 
information submitted in any amendment or supplement to your GRAS 
notice, or incorporated into your GRAS notice) are:
    (1) Considered a mandatory, rather than voluntary, submission for 
purposes of their status under the Freedom of Information Act and our 
public information requirements in part 20 of this chapter; and
    (2) Available for public disclosure in accordance with part 20 of 
this chapter as of the date that we receive your GRAS notice.
    (b) We will make the following readily accessible to the public:
    (1) A list of filed GRAS notices, including the information 
described in Sec. 570.225(c)(2) through (c)(5);
    (2) The text of any letter that we issue under Sec. 570.265(b)(1) 
or (c); and
    (3) The text of any letter that we issue under Sec. 570.265(b)(3) 
if we grant your request that we cease to evaluate your notice.
    (c) We will disclose all remaining data and information that are not 
exempt from public disclosure in accordance with part 20 of this 
chapter.



Sec. 570.280  Submission of a supplement.

    If circumstances warrant, you may submit a supplement to a filed 
GRAS notice after we respond to your notice by letter in accordance with 
Sec. 570.265(b)(1) or cease to evaluate your notice in accordance with 
Sec. 570.265(b)(3).



PART 571_FOOD ADDITIVE PETITIONS--Table of Contents



                      Subpart A_General Provisions

Sec.
571.1 Petitions.
571.6 Amendment of petition.
571.7 Withdrawal of petition without prejudice.

            Subpart B_Administrative Actions on Applications

571.100 Regulation based on petition.
571.102 Effective date of regulation.
571.110 Procedure for objections and hearings.
571.115 Application of the cancer clause of section 409 of the act.
571.130 Procedure for amending and repealing tolerances or exemptions 
          from tolerances.

    Authority: 21 U.S.C. 321, 342, 348, 371; 42 U.S.C. 241.

    Source: 41 FR 38647, Sept. 10, 1976, unless otherwise noted.



                      Subpart A_General Provisions



Sec. 571.1  Petitions.

    (a) Petitions to be filed with the Commissioner under the provisions 
of section 409(b) of the act shall be submitted in triplicate. If any 
part of the material submitted is in a foreign language, it shall be 
accompanied by an accurate and complete English translation. The 
petition shall state petitioner's post office address to which published 
notices or orders issued or objections filed pursuant to section 409 of 
the act may be sent.
    (b) Pertinent information may be incorporated in, and will be 
considered as part of, a petition on the basis of specific reference to 
such information submitted to and retained in the files of the Food and 
Drug Administration. However, any reference to unpublished information 
furnished by a person other than the applicant will not be

[[Page 550]]

considered unless use of such information is authorized in a written 
statement signed by the person who submitted it. Any reference to 
published information offered in support of a food-additive petition 
should be accompanied by reprints or photostatic copies of such 
references.
    (c) Petitions shall include the following data and be submitted in 
the following form:

                                                                  (Date)
Name of petitioner______________________________________________________
Post office address_____________________________________________________
Date____________________________________________________________________
Name of food additive and proposed use__________________________________

Food and Drug Administration
Center for Veterinary Medicine,
Director, Division of Animal Feeds (HFV-220), 7500 Standish Pl., 
          Rockville, MD 20855.

    Dear Sirs: The undersigned, ____

submits this petition pursuant to section 409(b)(1) of the Federal Food, 
Drug, and

Cosmetic Act with respect to____________________________________________

(Name of the food additive and proposed use)
    Attached hereto, in triplicate, and constituting a part of this 
petition, are the following:
    A. The name and all pertinent information concerning the food 
additive, including chemical identity and composition of the food 
additive, its physical, chemical, and biological properties, and 
specifications prescribing the minimum content of the desired 
component(s) and identifying and limiting the reaction byproducts and 
other impurities. Where such information is not available, a statement 
as to the reasons why it is not should be submitted.
    When the chemical identity and composition of the food additive is 
not known, the petition shall contain information in sufficient detail 
to permit evaluation regarding the method of manufacture and the 
analytical controls used during the various stages of manufacturing, 
processing, or packing of the food additive which are relied upon to 
establish that it is a substance of reproducible composition. 
Alternative methods and controls and variations in methods and controls 
within reasonable limits that do not affect the characteristics of the 
substance or the reliability of the controls may be specified.
    If the food additive is a mixture of chemicals, the petition shall 
supply a list of all substances used in the synthesis, extraction, or 
other method of preparation, regardless of whether they undergo chemical 
change in the process. Each substance should be identified by its common 
English name and complete chemical name, using structural formulas when 
necessary for specific identification. If any proprietary preparation is 
used as a component, the proprietary name should be followed by a 
complete quantitative statement of composition. Reasonable alternatives 
for any listed substance may be specified.
    If the petitioner does not himself perform all the manufacturing, 
processing, and packing operations for a food additive, the petition 
shall identify each person who will perform a part of such operations 
and designate the part.
    The petition shall include stability data, and, if the data indicate 
that it is needed to ensure the identity, strength, quality, or purity 
of the additive, the expiration date that will be employed.
    B. The amount of the food additive proposed for use and the purposes 
for which it is proposed, together with all directions, recommendations, 
and suggestions regarding the proposed use, as well as specimens of the 
labeling proposed for the food additive and any labeling that will be 
required by applicable provisions of the Federal Food, Drug, and 
Cosmetic Act on the finished food by reason of the use of the food 
additive. If the additive results or may reasonably be expected to 
result from the use of packaging material, the petitioner shall show how 
this may occur and what residues may reasonably be anticipated.
    (Typewritten or other draft-labeling copy will be accepted for 
consideration of the petition, provided a statement is made that final 
printed labeling identical in content to the draft copy will be 
submitted as soon as available and prior to the marketing of the food 
additive.
    If the food additive is one for which a tolerance limitation is 
required to assure its safety, the level of use proposed should be no 
higher than the amount reasonably required to accomplish the intended 
physical or other technical effect, even though the safety data may 
support a higher tolerance.)
    C. Data establishing that the food additive will have the intended 
physical or other technical effect or that it may reasonably be expected 
to become a component, or to affect the characteristics, directly or 
indirectly, of food and the amount necessary to accomplish this. These 
data should include information in sufficient detail to permit 
evaluation with control data.
    D. A description of practicable methods to determine the amount of 
the food additive in the raw, processed, and/or finished food and of any 
substance formed in or on such food because of its use. The test 
proposed shall be one that can be used for food-control purposes and 
that can be applied with consistent results by any properly equipped and 
trained laboratory personnel.

[[Page 551]]

    E. Full reports of investigations made with respect to the safety of 
the food additive.
    (A petition may be regarded as incomplete unless it includes full 
reports of adequate tests reasonably applicable to show whether or not 
the food additive will be safe for its intended use. The reports 
ordinarily should include detailed data derived from appropriate animal 
and other biological experiments in which the methods used and the 
results obtained are clearly set forth. The petition shall not omit 
without explanation any reports of investigations that would bias an 
evaluation of the safety of the food additive.)
    F. Proposed tolerances for the food additive, if tolerances are 
required in order to ensure its safety. A petitioner may include a 
proposed regulation.
    G. If submitting petition to modify an existing regulation issued 
pursuant to section 409(c)(1)(A) of the act, full information on each 
proposed change that is to be made in the original regulation must be 
submitted. The petition may omit statements made in the original 
petition concerning which no change is proposed. A supplemental petition 
must be submitted for any change beyond the variations provided for in 
the original petition and the regulation issued on the basis of the 
original petition.
    H. The petitioner is required to submit either a claim for 
categorical exclusion under Sec. 25.30 or Sec. 25.32 of this chapter 
or an environmental assessment under Sec. 25.40 of this chapter.
Yours very truly,
     Petitioner ____
     By ____
                                                    (Indicate authority)

    (d) The petitioner will be notified of the date on which his 
petition is filed, and an incomplete petition, or one that has not been 
submitted in triplicate, will usually be retained but not filed as a 
petition under section 409 of the act. The petitioner will be notified 
in what respects his petition is incomplete.
    (e) The petition must be signed by the petitioner or by his attorney 
or agent, or (if a corporation) by an authorized official.
    (f) The data specified under the several lettered headings should be 
submitted on separate sheets or sets of sheets, suitably identified. If 
such data have already been submitted with an earlier application, the 
present petition may incorporate it by specific reference to the 
earlier. If part of the data have been submitted by the manufacturer of 
the food additive as a master file, the petitioner may refer to the 
master file if and to the extent he obtains the manufacturer's written 
permission to do so. The manufacturer may authorize specific reference 
to the data without disclosure to the petitioner. Nothing herein shall 
prevent reference to published data.
    (g) A petition shall be retained but shall not be filed if any of 
the data prescribed by section 409(b) of the act are lacking or are not 
set forth so as to be readily understood.
    (h)(1) The following data and information in a food additive 
petition are available for public disclosure, unless extraordinary 
circumstances are shown, after the notice of filing of the petition is 
published in the Federal Register or, if the petition is not promptly 
filed because of deficiencies in it, after the petitioner is informed 
that it will not be filed because of the deficiencies involved:
    (i) All safety and functionality data and information submitted with 
or incorporated by reference in the petition.
    (ii) A protocol for a test or study, unless it is shown to fall 
within the exemption established for trade secrets and confidential 
commercial information in Sec. 20.61 of this chapter.
    (iii) Adverse reaction reports, product experience reports, consumer 
complaints, and other similar data and information, after deletion of:
    (a) Names and any information that would identify the person using 
the product.
    (b) Names and any information that would identify any third party 
involved with the report, such as a physician or hospital or other 
institution.
    (iv) A list of all ingredients contained in a food additive, whether 
or not it is in descending order of predominance. A particular 
ingredient or group of ingredients shall be deleted from any such list 
prior to public disclosure if it is shown to fall within the exemption 
established in Sec. 20.61 of this chapter, and a notation shall be made 
that any such ingredient list is incomplete.
    (v) An assay method or other analytical method, unless it serves no 
regulatory or compliance purpose and is shown to fall within the 
exemption established in Sec. 20.61 of this chapter.
    (2) The following data and information in a food additive petition 
are not available for public disclosure unless

[[Page 552]]

they have been previously disclosed to the public as defined in Sec. 
20.81 of this chapter or they relate to a product or ingredient that has 
been abandoned and they no longer represent a trade secret or 
confidential commercial or financial information as defined in Sec. 
20.61 of this chapter:
    (i) Manufacturing methods or processes, including quality control 
procedures.
    (ii) Production, sales, distribution, and similar data and 
information, except that any compilation of such data and information 
aggregated and prepared in a way that does not reveal data or 
information which is not available for public disclosure under this 
provision is available for public disclosure.
    (iii) Quantitative or semiquantitative formulas.
    (3) All correspondence and written summaries of oral discussions 
relating to a food additive petition are available for public disclosure 
in accordance with the provisions of part 20 of this chapter when the 
food additive regulation is published in the Federal Register.
    (4) For purposes of this regulation, safety and functionality data 
include all studies and tests of a food additive on animals and humans 
and all studies and tests on a food additive for identity, stability, 
purity, potency, performance, and usefulness.
    (i)(1) Within 15 days after receipt, the Commissioner will notify 
the petitioner of acceptance or nonacceptance of a petition, and if not 
accepted the reasons therefor. If accepted, the date of the notification 
letter sent to petitioner becomes the date of filing for the purposes of 
section 409(b)(5) of the act. If the petitioner desires, he may 
supplement a deficient petition after being notified regarding 
deficiencies. If the supplementary material or explanation of the 
petition is deemed acceptable, petitioner shall be notified. The date of 
such notification becomes the date of filing. If the petitioner does not 
wish to supplement or explain the petition and requests in writing that 
it be filed as submitted, the petition shall be filed and the petitioner 
so notified. The date of such notification becomes the date of filing.
    (2) The Commissioner will publish in the Federal Register within 30 
days from the date of filing of such petition, a notice of the filing, 
the name of the petitioner, and a brief description of the proposal in 
general terms. In the case of a food additive which becomes a component 
of food by migration from packaging material, the notice shall include 
the name of the migratory substance, and where it is different from that 
of one of the original components, the name of the parent component, the 
maximum quantity of the migratory substance that is proposed for use in 
food, and the physical or other technical effect which the migratory 
substance or its parent component is intended to have in the packaging 
material. A copy of the notice will be mailed to the petitioner when the 
original is forwarded to the Federal Register for publication.
    (j) The Commissioner may request a full description of the methods 
used in, and the facilities and controls used for, the production of the 
food additive, or a sample of the food additive, articles used as 
components thereof, or of the food in which the additive is proposed to 
be used, at any time while a petition is under consideration. The 
Commissioner shall specify in the request for a sample of the food 
additive, or articles used as components thereof, or of the food in or 
on which the additive is proposed to be used, a quantity deemed adequate 
to permit tests of analytical methods to determine quantities of the 
food additive present in foods for which it is intended to be used or 
adequate for any study or investigation reasonably required with respect 
to the safety of the food additive or the physical or technical effect 
it produces. The date used for computing the 90-day limit for the 
purposes of section 409(c)(2) of the act shall be moved forward 1 day 
for each day after the mailing date of the request taken by the 
petitioner to submit the sample. If the information or sample is 
requested a reasonable time in advance of the 180 days, but is not 
submitted within such 180 days after filing of the petition, the 
petition will be considered withdrawn without prejudice.
    (k) If nonclinical laboratory studies are involved, petitions filed 
with the

[[Page 553]]

Commissioner under section 409(b) of the act shall include, with respect 
to each study, either a statement that the study was conducted in 
compliance with the requirements set forth in part 58 of this chapter, 
or, if the study was not conducted in compliance with such regulations, 
a brief statement of the reason for the noncompliance.

[41 FR 38647, Sept. 10, 1976, as amended at 42 FR 15675, Mar. 22, 1977; 
50 FR 7518, Feb. 22, 1985; 50 FR 16668, Apr. 26, 1985; 52 FR 8583, Mar. 
19, 1987; 57 FR 6476, Feb. 25, 1992; 62 FR 40600, July 29, 1997]



Sec. 571.6  Amendment of petition.

    After a petition has been filed, the petitioner may submit 
additional information or data in support thereof. In such cases, if the 
Commissioner determines that the additional information or data amounts 
to a substantive amendment, the petition as amended will be given a new 
filing date, and the time limitation will begin to run anew. If 
nonclinical laboratory studies are involved, additional information and 
data submitted in support of filed petitions shall include, with respect 
to each such study, either a statement that the study was conducted in 
compliance with the requirements set forth in part 58 of this chapter, 
or, if the study was not conducted in compliance with such regulations, 
a brief statement of the reason or the noncompliance.

[41 FR 38647, Sept. 10, 1976, as amended at 50 FR 7518, Feb. 22, 1985; 
50 FR 16668, Apr. 26, 1985]



Sec. 571.7  Withdrawal of petition without prejudice.

    (a) In some cases the Commissioner will notify the petitioner that 
the petition, while technically complete, is inadequate to justify the 
establishment of a regulation or the regulation requested by petitioner. 
This may be due to the fact that the data are not sufficiently clear or 
complete. In such cases, the petitioner may withdraw the petition 
pending its clarification or the obtaining of additional data. This 
withdrawal will be without prejudice to a future filing. Upon refiling, 
the time limitation will begin to run anew from the date of refiling.
    (b) At any time before the order provided for in Sec. 571.100(a) 
has been forwarded to the Federal Register for publication, the 
petitioner may withdraw the petition without prejudice to a future 
filing. Upon refiling the time limitation will begin to run anew.



            Subpart B_Administrative Actions on Applications



Sec. 571.100  Regulation based on petition.

    (a) The Commissioner will forward for publication in the Federal 
Register, within 90 days after filing of the petition (or within 180 
days if the time is extended as provided for in section 409(c)(2) of the 
act), a regulation prescribing the conditions under which the food 
additive may be safely used (including, but not limited to, 
specifications as to the particular food or classes of food in or on 
which such additive may be used, the maximum quantity that may be used 
or permitted to remain in or on such food, the manner in which such 
additive may be added to or used in or on such food, and any directions 
or other labeling or packaging requirements for such additive deemed 
necessary by him to assure the safety of such use), and prior to the 
forwarding of the order to the Federal Register for publication shall 
notify the petitioner of such order and the reasons for such action; or 
by order deny the petition, and shall notify the petitioner of such 
order and of the reasons for such action.
    (b) If the Commissioner determines that additional time is needed to 
study and investigate the petition, he shall by written notice to the 
petitioner extend the 90-day period for not more than 180 days after the 
filing of the petition.



Sec. 571.102  Effective date of regulation.

    A regulation published in accordance with Sec. 571.100(a) shall 
become effective upon publication in the Federal Register.



Sec. 571.110  Procedure for objections and hearings.

    Objections and hearings relating to food additive regulations under 
section

[[Page 554]]

409(c), (d), or (h) of the act shall be governed by part 12 of this 
chapter.

[42 FR 4717, Jan. 25, 1977, as amended at 42 FR 15676, Mar. 22, 1977]



Sec. 571.115  Application of the cancer clause of section 409 of the act.

    Food additives intended for use as an ingredient in food for animals 
that are raised for food production and that have the potential to 
contaminate human food with residues whose consumption could present a 
risk of cancer to people must satisfy the requirements of subpart E of 
part 500 of this chapter.

[52 FR 49588, Dec. 31, 1987]



Sec. 571.130  Procedure for amending and repealing tolerances 
or exemptions from tolerances.

    (a) The Commissioner, on his own initiative or on the petition of 
any interested person, pursuant to part 10 of this chapter, may propose 
the issuance of a regulation amending or repealing a regulation 
pertaining to a food additive or granting or repealing an exception for 
such additive.
    (b) Any such petition shall include an assertion of facts, supported 
by data, showing that new information exists with respect to the food 
additive or that new uses have been developed or old uses abandoned, 
that new data are available as to toxicity of the chemical, or that 
experience with the existing regulation or exemption may justify its 
amendment or repeal. New data shall be furnished in the form specified 
in Sec. 571.1 for submitting petitions.

[42 FR 4717, Jan. 25, 1977; 42 FR 15676, Mar. 22, 1977]



PART 573_FOOD ADDITIVES PERMITTED IN FEED AND DRINKING
WATER OF ANIMALS--Table of Contents



Subpart A [Reserved]

                     Subpart B_Food Additive Listing

Sec.
573.120 Acrylamide-acrylic acid resin.
573.130 Aminoglycoside 3'-phospho- transferase II.
573.140 Ammoniated cottonseed meal.
573.160 Ammoniated rice hulls.
573.170 Ammonium formate.
573.180 Anhydrous ammonia.
573.200 Condensed animal protein hydrolysate.
573.210 Benzoic acid.
573.220 Feed-grade biuret.
573.225 1,3-Butylene glycol.
573.240 Calcium periodate.
573.260 Calcium silicate.
573.280 Feed-grade calcium stearate and sodium stearate.
573.300 Choline xanthate.
573.304 Chromium propionate.
573.310 Crambe meal, heat toasted.
573.320 Diammonium phosphate.
573.340 Diatomaceous earth.
573.360 Disodium EDTA.
573.380 Ethoxyquin in animal feeds.
573.400 Ethoxyquin in certain dehydrated forage crops.
573.420 Ethyl cellulose.
573.440 Ethylene dichloride.
573.450 Fermented ammoniated condensed whey.
573.460 Formaldehyde.
573.480 Formic acid.
573.490 Gamma-linolenic acid safflower meal.
573.492 Gamma-linolenic acid safflower oil.
573.496 Guanidinoacetic acid.
573.500 Condensed, extracted glutamic acid fermentation product.
573.520 Hemicellulose extract.
573.530 Hydrogenated corn syrup.
573.540 Hydrolyzed leather meal.
573.550 25-hydroxyvitamin D3.
573.560 Iron ammonium citrate.
573.580 Iron-choline citrate complex.
573.600 Lignin sulfonates.
573.615 Marine microalgae.
573.620 Menadione dimethylpyrimidinol bisulfite.
573.625 Menadione nicotinamide bisulfite.
573.637 Methyl esters of conjugated linoleic acid (cis-9, trans-11 and 
          trans-10, cis-12-octadecadienoic acids).
573.640 Methyl esters of higher fatty acids.
573.660 Methyl glucoside-coconut oil ester.
573.680 Mineral oil.
573.685 Natamycin.
573.696 Feed grade sodium formate.
573.700 Sodium nitrite.
573.720 Petrolatum.
573.740 Odorless light petroleum hydrocarbons.
573.750 Pichia pastoris dried yeast.
573.760 Poloxalene.
573.780 Polyethylene.
573.800 Polyethylene glycol (400) mono- and dioleate.
573.820 Polyoxyethylene glycol (400) mono- and dioleates.
573.840 Polysorbate 60.
573.860 Polysorbate 80.
573.870 Poly(2-vinylpyridine-co-styrene).
573.880 Normal propyl alcohol.
573.900 Pyrophyllite.
573.914 Salts of volatile fatty acids.

[[Page 555]]

573.920 Selenium.
573.940 Silicon dioxide.
573.960 Sorbitan monostearate.
573.980 Taurine.
573.1000 Verxite.
573.1010 Xanthan gum.
573.1020 Yellow prussiate of soda.

    Authority: 21 U.S.C. 321, 342, 348.

    Source: 41 FR 38652, Sept. 10, 1976, unless otherwise noted.

Subpart A [Reserved]



                     Subpart B_Food Additive Listing



Sec. 573.120  Acrylamide-acrylic acid resin.

    Acrylamide-acrylic acid resin (hydrolized polyacrylamide), only for 
the purposes of this section as described below, may be safely used in 
accordance with the following prescribed conditions:
    (a) The additive is produced by polymerization of acrylamide with 
partial hydrolysis, or by copolymerization of acrylamide and acrylic 
acid with the greater part of the polymer being composed of acrylamide 
units.
    (b) The additive meets the following specifications:
    (1) A minimum molecular weight of 3 million.
    (2) Viscosity range: 3,000 to 6,000 centipoises at 77 [deg]F in a 1 
percent aqueous solution as determined by LVF Brookfield Viscometer or 
equivalent using a number 6 spindle at 20 r.p.m.
    (3) Residual acrylamide: Not more than 0.05 percent.
    (c) It is used as a thickener and suspending agent in nonmedicated 
aqueous suspensions intended for addition to animal feeds.

[41 FR 38652, Sept. 10, 1976, as amended at 45 FR 38058, June 6, 1980]



Sec. 573.130  Aminoglycoside 3'-phospho- transferase II.

    The food additive aminoglycoside 3'-phosphotransferase II may be 
safely used in the development of genetically modified cotton, oilseed 
rape, and tomatoes in accordance with the following prescribed 
conditions:
    (a) The food additive is the enzyme aminoglycoside 3'-
phosphotransferase II (CAS Reg. No. 58943-39-8) which catalyzes the 
phosphorylation of certain aminoglycoside antibiotics, including 
kanamycin, neomycin, and gentamicin.
    (b) Aminoglycoside 3'-phosphotransferase II is encoded by the kan\r\ 
gene originally isolated from transposon Tn5 of the bacterium 
Escherichia coli.
    (c) The level of the additive does not exceed the amount reasonably 
required for selection of plant cells carrying the kan\r\ gene along 
with the genetic material of interest.

[59 FR 26711, May 23, 1994]



Sec. 573.140  Ammoniated cottonseed meal.

    The food additive ammoniated cottonseed meal may be safely used in 
accordance with the following conditions:
    (a) The food additive is the product obtained by the treatment of 
cottonseed meal with anhydrous ammonia until a pressure of 50 pounds per 
square inch gauge is reached.
    (b) It is used or intended for use in the feed of ruminants as a 
source of protein and/or as a source of nonprotein nitrogen in an amount 
not to exceed 20 percent of the total ration.
    (c) To assure safe use, the label and labeling of the additive and 
of any feed additive supplement, concentrate, or premix prepared 
therefrom shall bear, in addition to the other information required by 
the act, the following:
    (1) The name of the additive.
    (2) The maximum percentage of equivalent crude protein from the 
nonprotein nitrogen.
    (3) Directions for use to provide not more than 20 percent of the 
additive in the total ration.
    (4) A statement:
    (i) That not more than one-third of the total protein in the feed 
should come from nonprotein nitrogen sources.
    (ii) That the additive is not to be given to debilitated or starved 
animals.
    (iii) ``Warning--This feed should be used only in accordance with 
directions furnished on the label.''

[41 FR 38652, Sept. 10, 1976, as amended at 42 FR 52397, Sept. 30, 1977]



Sec. 573.160  Ammoniated rice hulls.

    The food additive ammoniated rice hulls may be safely used in 
accordance

[[Page 556]]

with the following prescribed conditions:
    (a) The food additive is the product obtained by the treatment of 
ground rice hulls with monocalcium phosphate and anhydrous ammonia at a 
temperature of 350 [deg]F and a pressure of 175 pounds per square inch.
    (b) It is used or intended for use in the feed of beef cattle as a 
source of crude fiber and as the sole source of nonprotein nitrogen in 
an amount not to exceed 20 percent of the total ration.
    (c) To assure safe use of the additive, the label and labeling of 
the additive and of any feed additive supplement, feed additive 
concentrate, or feed additive premix prepared therefrom, shall contain, 
in addition to other information required by the act, the following:
    (1) The name of the additive.
    (2) The maximum percentage of equivalent crude protein from the 
nonprotein nitrogen.
    (3) Directions for use to provide not more than 20 percent of the 
additive in the total ration, and a prominent statement: ``Warning--This 
feed should be used only in accordance with the directions furnished on 
the label.''



Sec. 573.170  Ammonium formate.

    The food additive, ammonium formate, may be safely used in the 
manufacture of complete swine feeds in accordance with the following 
prescribed conditions:
    (a) The additive is manufactured by the reaction of 99.5 percent 
ammonia gas and 99 percent formic acid in a continuous loop reactor to 
produce a solution made up of 37 percent ammonium salt of formic acid 
and 62 percent formic acid.
    (b) The additive is used or intended for use as a feed acidifying 
agent, to lower the pH, in complete swine feeds at levels not to exceed 
1.2 percent of the complete feed.
    (c) To ensure safe use of the additive, formic acid and formate 
salts from all added sources cannot exceed 1.2 percent of complete feed 
when multiple sources of formic acid and its salts are used in 
combination.
    (d) To assure safe use of the additive, in addition to the other 
information required by the Federal Food, Drug, and Cosmetic Act (the 
act), the label and labeling shall contain:
    (1) The name of the additive.
    (2) Adequate directions for use including a statement that ammonium 
formate must be uniformly applied and thoroughly mixed into complete 
swine feeds and that the complete swine feeds so treated shall be 
labeled as containing ammonium formate.
    (3) Cautions for use including this statement: Caution: Follow label 
directions. Formic acid and formate salts from all added sources cannot 
exceed 1.2 percent of complete feed when multiple sources of formic acid 
and its salts are used in combination.
    (e) To ensure safe use of the additive, in addition to the other 
information required by the Federal Food, Drug, and Cosmetic Act and 
paragraph (d) of this section, the label and labeling shall contain:
    (1) Appropriate warnings and safety precautions concerning ammonium 
formate (37 percent ammonium salt of formic acid and 62 percent formic 
acid).
    (2) Statements identifying ammonium formate in formic acid (37 
percent ammonium salt of formic acid and 62 percent formic acid) as a 
corrosive and possible severe irritant.
    (3) Information about emergency aid in case of accidental exposure 
as follows:
    (i) Statements reflecting requirements of applicable sections of the 
Superfund Amendments and Reauthorization Act (SARA), and the 
Occupational Safety and Health Administration's (OSHA) human safety 
guidance regulations.
    (ii) Contact address and telephone number for reporting adverse 
reactions or to request a copy of the Material Safety Data Sheet (MSDS).

[75 FR 41725, July 19, 2010, as amended at 78 FR 42692, July 17, 2013; 
82 FR 52209, Nov. 13, 2017]



Sec. 573.180  Anhydrous ammonia.

    (a) The food additive anhydrous ammonia is applied directly to corn 
plant material and thoroughly blended prior to ensiling. It is used or 
intended for use as a source of nonprotein nitrogen in cattle feed in 
accordance with paragraphs (a)(1), (2), or (3) as follows:

[[Page 557]]

    (1)(i) The food additive anhydrous ammonia is applied as a component 
of an aqueous premix containing 16 to 17 percent ammonia, with molasses, 
minerals, and not less than 83 percent crude protein. The premix is a 
source of nonprotein nitrogen and minerals.
    (ii) In addition to the requirements of paragraph (b) of this 
section, the labeling shall bear an expiration date of not more than 10 
weeks after date of manufacture; a statement that additional protein 
should not be fed to lactating dairy cows producing less than 32 pounds 
of milk per day nor beef cattle consuming less than 1 percent of body 
weight daily in shelled corn; and a warning not to use additional trace 
mineral supplementation with treated silage.
    (2)(i) The food additive anhydrous ammonia is applied directly to 
corn plant material for use in dairy or beef cattle rations.
    (ii) The anhydrous ammonia is applied at a rate not to exceed the 
equivalent of 0.35 percent of the corn plant material.
    (iii) It is applied to corn plant material containing 30 to 35 
percent dry matter.
    (iv) It is applied so that 75 to 85 percent of the additive is 
liquid at ambient pressure.
    (3)(i) The food additive anhydrous ammonia is applied after being 
diluted to a 15 to 30 percent aqueous ammonia solution (by weight).
    (ii) The anhydrous ammonia solution is applied at a rate not to 
exceed anhydrous ammonia equivalent to 0.3 percent of the corn plant 
material.
    (iii) It is applied to corn plant material containing 28 to 38 
percent dry matter.
    (iv) The silage treated with aqueous ammonia is to be fed to dairy 
cattle only.
    (b) Its labeling shall bear, in addition to the other requirements 
of the act, the name of the additive, the concentration of ammonia, the 
maximum percentage of equivalent crude protein from nonprotein nitrogen, 
and directions for use consistent with this section.

[44 FR 40284, July 10, 1979]



Sec. 573.200  Condensed animal protein hydrolysate.

    (a) Identity. The condensed animal protein hydrolysate is produced 
from the meat byproducts scraped from cured (salted) hides taken from 
cattle slaughtered for food consumption. The meat byproduct is 
hydrolyzed with heat and phosphoric acid.
    (b) Specifications. The additive shall conform to the following 
percent-by-weight specifications:

Moisture, not less than 45 percent nor more than 50 percent.
Protein, not less than 24 percent.
Salt (NaCl), not more than 15 percent.
Phosphorus, not less than 2.25 percent.

    (c) Uses. It is used or intended for use as a source of animal 
protein, phosphorus, and salt (NaCl) as follows:
    (1) In poultry and swine feed in an amount not to exceed 5 percent 
by weight of the feed.
    (2) In feed concentrates for cattle in an amount not to exceed 10 
percent by weight of the concentrate.
    (d) Labeling. The label and labeling shall bear, in addition to the 
other information required by the act:
    (1) The name of the additive, condensed animal protein hydrolysate.
    (2) Adequate directions for use including maximum quantities 
permitted for each species and a guaranteed analysis of the additive.



Sec. 573.210  Benzoic acid.

    The food additive, benzoic acid, may be safely used in the 
manufacture of complete swine feeds in accordance with the following 
prescribed conditions:
    (a) The additive is used or intended for use as a feed acidifying 
agent, to lower the pH, in complete swine feeds at levels not to exceed 
0.5 percent of the complete feed.
    (b) The additive consists of not less than 99.5 percent benzoic acid 
(CAS 65-85-0) by weight with the sum of 2-methylbiphenyl, 3-
methylbiphenyl, 4-methylbiphenyl, benzyl benzoate, and isomers of 
dimethylbiphenyl not to exceed 0.01 percent by weight.
    (c) To assure safe use of the additive, in addition to the other 
information required by the Federal Food, Drug, and Cosmetic Act and 
paragraph (b) of this

[[Page 558]]

section, the label and labeling shall contain:
    (1) The name of the additive.
    (2) Adequate directions for use including a statement that benzoic 
acid must be uniformly applied and thoroughly mixed into complete swine 
feeds and that the complete swine feeds so treated shall be labeled as 
containing benzoic acid.
    (3) Appropriate warnings and safety precautions concerning benzoic 
acid.
    (4) A warning statement identifying benzoic acid as a possible 
irritant.
    (5) Information about emergency aid in case of accidental exposure.
    (6) Contact address and telephone number for reporting adverse 
reactions or to request a copy of the Material Safety Data Sheet (MSDS).

[79 FR 14176, Mar. 13, 2014]



Sec. 573.220  Feed-grade biuret.

    The food additive feed grade biuret may be safely used in ruminant 
feed in accordance with the following prescribed conditions:
    (a) The food additive is the product resulting from the controlled 
pyrolysis of urea conforming to the following specifications:

------------------------------------------------------------------------
                                                      Percent
------------------------------------------------------------------------
Biuret...................................  55 minimum.
Urea.....................................  15 maximum.
Cyanuric acid and triuret................  30 maximum.
Mineral oil..............................  0.5 maximum.
Total nitrogen (equivalent to 218.75 pct   35 minimum.
 crude protein).
------------------------------------------------------------------------

    (b) It is used in ruminant feeds as a source of nonprotein nitrogen.
    (c) To assure safe use of the additive:
    (1) The label and labeling of the additive and that of any feed 
additive supplement, feed additive concentrate, feed additive premix, or 
complete feed prepared therefrom shall contain, in addition to other 
information required by the act, the following:
    (i) The name of the additive.
    (ii) The maximum percentage of equivalent crude protein from 
nonprotein nitrogen.
    (2) The label shall recommend that the diet be balanced to provide 
adequate nutrients when equivalent crude protein from all forms of 
nonprotein nitrogen exceed one-third of the total crude protein in the 
total daily ration.

[41 FR 38652, Sept. 10, 1976, as amended at 68 FR 27904, May 22, 2003]



Sec. 573.225  1,3-Butylene glycol.

    The food additive 1,3-butylene glycol (1,3-butanediol) may be safely 
used in accordance with the following prescribed conditions:
    (a) It complies with the specifications in Sec. 173.220(a) of this 
chapter.
    (b) It is intended for use in swine feed as a source of energy.
    (c) It is to be thoroughly mixed into feed at levels not to exceed 9 
percent of the dry matter of the total ration.
    (d) 1,3-Butylene glycol should be mixed in feed with equipment 
adapted for the addition of liquids, and the feed should be mixed not 
less than 5 minutes after its addition.

[53 FR 40061, Oct. 13, 1988]



Sec. 573.240  Calcium periodate.

    The food additive calcium periodate may be safely used in accordance 
with the following prescribed conditions:
    (a) The additive is produced by reacting calcium iodate with calcium 
hydroxide or calcium oxide to form a substance consisting of not less 
than 60 percent by weight of penta calcium orthoperiodate containing 28 
to 31 percent by weight of iodine.
    (b) It is used or intended for use in salt for livestock as a source 
of iodine.



Sec. 573.260  Calcium silicate.

    Calcium silicate, including synthetic calcium silicate, may be 
safely used as an anticaking agent in animal feed, provided that the 
amount of calcium silicate does not exceed 2 percent.



Sec. 573.280  Feed-grade calcium stearate and sodium stearate.

    Feed-grade calcium stearate and sodium stearate may be safely used 
in an animal feed in accordance with the following prescribed 
conditions:
    (a) Feed-grade calcium stearate and sodium stearate are the calcium 
or sodium salts of a fatty acid mixture that is predominately stearic 
acid. Associated fatty acids, including palmitic acid and minor amounts 
of lauric, myristic, pentadecanoic, margaric,

[[Page 559]]

arachidic, and other fatty acids may be contained in the mixture, but 
such associated fatty acids in aggregate do not exceed 35 percent by 
weight of the mixture. The fatty acids may be derived from feed-grade 
fats or oils.
    (b) The additives meet the following specifications:
    (1) Unsaponifiable matter does not exceed 2 percent.
    (2) They are free of chick-edema factor.
    (c) The additives are manufactured so that in aqueous solution they 
are exposed for 1 hour or longer to temperature in excess of 180 [deg]F.
    (d) They are used as anticaking agents in animal feeds in accordance 
with current good manufacturing practices.

[63 FR 8573, Feb. 20, 1998]



Sec. 573.300  Choline xanthate.

    Choline xanthate may be safely used as a component of animal feed as 
an added source of choline to supplement the diets of poultry, 
ruminants, and swine in accordance with good feeding practice.



Sec. 573.304  Chromium Propionate.

    The food additive chromium propionate may be safely used in animal 
feed as a source of supplemental chromium in accordance with the 
following prescribed conditions:
    (a) The additive is manufactured by the reaction of a chromium salt 
with propionic acid, at an appropriate stoichiometric ratio, to produce 
triaqua-(mu3-oxo) hexakis (mu2-propionato-
O,O[min]) trichromium propionate with the empirical formula, 
[Cr3(O)(CH3CH2CO2)6
(H2O)3]CH3CH2CO2.
    (b) The additive is added to feed as follows:
    (1) In complete feed for broiler chickens at a level not to exceed 
0.2 milligrams (mg) of chromium from chromium propionate per kilogram 
feed.
    (2) In feed for horses at a level not to exceed an intake of 4 mg of 
chromium from chromium propionate per horse per day.
    (c) The additive meets the following specifications:
    (1) Total chromium content, 8 to 10 percent.
    (2) Hexavalent chromium content, less than 2 parts per million 
(ppm).
    (3) Arsenic, less than 1 ppm.
    (4) Cadmium, less than 1 ppm.
    (5) Lead, less than 0.5 ppm.
    (6) Mercury, less than 0.5 ppm.
    (7) Viscosity, not more than 2,000 centipoise.
    (d) The additive shall be incorporated into feed as follows:
    (1) It shall be incorporated into each ton of feed by adding no less 
than one pound of a premix containing no more than 181.4 milligrams of 
added chromium from chromium propionate per pound.
    (2) The premix manufacturer shall follow good manufacturing 
practices in the production of chromium propionate premixes. Inventory, 
production, and distribution records must provide a complete and 
accurate history of product production.
    (3) Chromium from all sources of supplemental chromium cannot 
exceed:
    (i) A level of 0.2 ppm in complete feed for broiler chickens.
    (ii) An intake of 4 mg per horse per day.
    (e) To assure safe use of the additive in addition to the other 
information required by the Federal Food, Drug, and Cosmetic Act:
    (1) The label and labeling of the additive, any feed premix, and 
feed shall contain the name of the additive.
    (2) The label and labeling of the additive and any feed premix shall 
also contain:
    (i) A guarantee for added chromium content.
    (ii) Adequate directions for use and cautions for use including 
these statements: ``Caution: Follow label directions'' and consistent 
with the directions for use, the following:
    (A) For feed for broiler chickens, ``Chromium from all sources of 
supplemental chromium cannot exceed 0.2 parts per million of the 
complete feed for broiler chickens.''
    (B) For feed for horses, ``Chromium from all sources of supplemental 
chromium cannot exceed 4 milligrams per horse per day.''

[81 FR 35611, June 3, 2016, as amended at 85 FR 14566, Mar. 13, 2020; 85 
FR 48650, Aug. 12, 2020]

[[Page 560]]



Sec. 573.310  Crambe meal, heat toasted.

    (a) The additive is the seed meal of Crambe abyssinica obtained 
after the removal of oil from the seed and hull. The oil may be removed 
by pre-press solvent extraction or by solvent extraction alone. The 
resulting seed meal is heat toasted.
    (b) The additive conforms to the following percent-by-weight 
specifications: moisture, not more than 11 percent; oil, not more than 4 
percent; crude protein, not less than 24 percent; crude fiber, not more 
than 26 percent; glucosinolate calculated as epi-progoitrin, not more 
than 4 percent; goitrin, not more than 0.1 percent; nitrile calculated 
as 1-cyano-2-hydroxy-3-butene, not more than 1.4 percent. At least 50 
percent of the nitrogen shall be soluble in 0.5 M sodium chloride. 
Myrosinase enzyme activity shall be absent.
    (c) The additive is used or intended for use in the feed of feedlot 
cattle as a source of protein in an amount not to exceed 4.2 percent of 
the total ration.

[46 FR 30082, June 5, 1981]



Sec. 573.320  Diammonium phosphate.

    The food additive diammonium phosphate may be safely used in 
ruminant feed in accordance with the following prescribed conditions:
    (a) The food additive is the product resulting from the 
neutralization of feeding-phosphoric-acid or defluorinated wet-process 
phosphoric acid with anhydrous ammonia. It contains not less than 106.25 
percent equivalent crude protein (nitrogen x 6.25) and 20 percent 
phosphorus. It contains not more than the following:

1 part fluorine to 100 parts phosphorus.
75 parts per million or arsenic (as As).
30 parts per million of heavy metals, as lead (Pb).

    (b) It is used in ruminant feeds as a source of phosphorus and 
nitrogen in an amount that supplies not more than 2 percent of 
equivalent crude protein in the total daily ration.
    (c) To assure safe use of the additive, the label and labeling of 
the additive and that of any feed additive supplement, feed additive 
concentrate, feed additive premix, or complete feed prepared therefrom 
shall contain, in addition to other information required by the act, the 
following:
    (1) The name of the additive.
    (2) The maximum percentage of equivalent crude protein from the 
nonprotein nitrogen.
    (3) If the feed additive premix, feed additive concentrate, or feed 
additive supplement contains more than 2 percent equivalent crude 
protein from diammonium phosphate, adequate directions for use and a 
prominent statement, ``Warning--This feed should be used only in 
accordance with directions furnished on the label.''



Sec. 573.340  Diatomaceous earth.

    (a) Identity. The additive consists of siliceous skeletal material 
derived from various species of diatoms.
    (b) Specifications. The additive shall conform to the following 
specifications:

Lead, not more than 15 parts per million.
Arsenic (as As), not more than 20 parts per million
Fluorine, not more than 600 parts per million.

    (c) Uses. It is used or intended for use as an inert carrier or 
anticaking agent in animal feeds in an amount not to exceed 2 percent by 
weight of the total ration.



Sec. 573.360  Disodium EDTA.

    The food additive disodium EDTA (disodium ethylenediaminetetraace- 
tate) may be safely used in animal feeds, in accordance with the 
following prescribed conditions:
    (a) The food additive contains a minimum of 99 percent disodium 
ethylenediaminetetraacetate dihydrate 
(C10H14O8N2Na2 
[middot] 2H2O).
    (b) It is used to solubilize trace minerals in aqueous solutions, 
which are then added to animal feeds.
    (c) It is used or intended for use in an amount not to exceed 240 
parts per million of the additive in finished feed.
    (d) To assure safe use of the additive the label and labeling shall 
bear:
    (1) The name of the additive; and
    (2) Adequate mixing directions to ensure that the chelated trace-
mineral mix is uniformly blended throughout the feed.

[[Page 561]]



Sec. 573.380  Ethoxyquin in animal feeds.

    Ethoxyquin (1,2-dihydro-6-ethoxy-2,2,4-trimethylquinoline) may be 
safely used in animal feeds, when incorporated therein in accordance 
with the following prescribed conditions.
    (a) It is intended for use only: (1) As a chemical preservative for 
retarding oxidation of carotene, xanthophylls, and vitamins A and E in 
animal feed and fish food and, (2) as an aid in preventing the 
development of organic peroxides in canned pet food.
    (b) The maximum quantity of the additive permitted to be used and to 
remain in or on the treated article shall not exceed 150 parts per 
million.
    (c) To assure safe use of the additive, the label and labeling of 
the food additive container and that of any intermediate premixes 
prepared therefrom shall contain, in addition to other information 
required by the act:
    (1) The name of the additive, ethoxyquin.
    (2) A statement of the concentration or strength contained therein.
    (3) Adequate use directions to provide for a finished article with 
the proper concentration of the additive as provided in paragraph (b) of 
this section, whether or not intermediate premixes are to be used.
    (d) The label of any animal feed containing the additive shall, in 
addition to the other information required by the act, bear the 
statement ``Ethoxyquin, a preservative'' or ``Ethoxyquin added to retard 
the oxidative destruction of carotene, xanthophylls, and vitamins A and 
E.''



Sec. 573.400  Ethoxyquin in certain dehydrated forage crops.

    Ethoxyquin (1,2-dihydro-6-ethoxy-2,2,4-trimethylquinoline) may be 
safely used in the dehydrated forage crops listed in paragraph (a) of 
this section when incorporated therein in accordance with the conditions 
prescribed in this section:
    (a) It may be added to dehydrated forage prepared from:

Alfalfa...................................  Medicago sativa.
Barley....................................  Hordeum vulgare.
Clovers:
  Alsike clover...........................  Trifolium hybridum.
  Crimson clover..........................  Trifolium incarnatum.
  Red clover..............................  Trifolium pratense.
  White clover (including Ladino).........  Trifolium repens.
  White sweetclover.......................  Melilotus alba.
  Yellow sweetclover......................  Melilotus officinalis.
Coastal Bermudagrass......................  Cynodon dactylon.
Corn......................................  Zea mays.
Fescue....................................  Festuca sp.
Oats......................................  Avena sativa.
Orchardgrass..............................  Dactylis glomerata.
Reed canarygrass..........................  Pharlaris arundinacea.
Ryegrass (annual and perennial)...........  Elymus sp. and Lolium
                                             perenne.
Sorghums..................................  Sorghum vulgare vars,
                                             feterita, shallu, kaoliang,
                                             broomcorn.
Sudan grass...............................  Sorghum vulgare sudanense.
Wheat.....................................  Triticum aestivum.
 


or any mixture of such forage crops, for use only as an animal feed.
    (b) Such additive is used only as a chemical preservative for the 
purpose of retarding oxidative destruction of naturally occurring 
carotenes and vitamin E in the forage crops.
    (c) It is added to the dehydrated forage crops in an oil mixture 
containing only suitable animal or suitable vegetable oil, prior to 
grinding and mixing.
    (d) The maximum quantity of the additive permitted to be used and to 
remain in or on the dehydrated forage crop shall not exceed 150 parts 
per million.
    (e) To assure the safe use of the additive, the label of the market 
package shall contain, in addition to other information required by the 
act:
    (1) The name of the additive as specified in this section.
    (2) Directions for the incorporation of the additive in the forage 
crops, as specified in paragraph (c) of this section, with the directive 
that only suitable animal or suitable vegetable oils are to be used in 
the oil mix.
    (f) The label of any dehydrated forage crops treated with the 
additive or the label of an animal-feed supplement containing such 
treated forage crops, shall, in addition to other information required 
by the act, bear the following statements:
    (1) ``Ethoxyquin, a preservative,'' or ``Ethoxyquin added to retard 
the oxidative destruction of carotene and vitamin E.''
    (2) The statement ``For use in animal feed only.''

[[Page 562]]



Sec. 573.420  Ethyl cellulose.

    The food additive ethyl cellulose may be safely used in animal feed 
in accordance with the following prescribed conditions:
    (a) The food additive is a cellulose ether containing ethoxy 
(OC2H5) groups attached by an ether linkage and 
containing on an anhydrous basis not more than 2.6 ethoxy groups per 
anhydroglucose unit.
    (b) It is used or intended for use as a binder or filler in dry 
vitamin preparations to be incorporated into animal feed.



Sec. 573.440  Ethylene dichloride.

    The food additive ethylene dichloride may be safely used in the 
manufacture of animal feeds in accordance with the following prescribed 
conditions:
    (a) It is used as a solvent in the extraction processing of animal 
byproducts for use in animal feeds.
    (b) The maximum quantity of the additive permitted to remain in or 
on the extracted byproducts shall not exceed 300 parts per million.
    (c) The extracted animal byproduct is added as a source of protein 
to a total ration at levels consistent with good feeding practices, but 
in no event at levels exceeding 13 percent of the total ration.



Sec. 573.450  Fermented ammoniated condensed whey.

    (a) Identity. The product is produced by the Lactobacillus 
bulgaricus fermentation of whey with the addition of ammonia.
    (b) Specifications. The product contains 35 to 55 percent crude 
protein and not more than 42 percent equivalent crude protein from 
nonprotein nitrogen sources.
    (c) Uses. The product is used as a source of protein and nonprotein 
nitrogen for cattle.
    (d) Limitations. (1) Store in a closed vented tank equipped for 
agitation. Agitate 5 minutes before using. Do not store at temperature 
above 110 [deg]F (43 [deg]C).
    (2) The maximum level of use of fermented ammoniated condensed whey 
and equivalent crude protein from all other added forms of nonprotein 
nitrogen shall not exceed 30 percent of the dietary crude protein.
    (3) The additive may be used as follows:
    (i) Mixed with grain, roughage, or grain and roughage prior to 
feeding.
    (ii) As a component of free-choice liquid feeds, used to supplement 
the diets of cattle fed other sources of nutrients, fermented ammoniated 
condensed whey shall not exceed 80 percent of the free-choice liquid 
feed.
    (e) Labeling. The label shall bear, in addition to other information 
required by the act:
    (1) The name of the additive.
    (2) The maximum percentage of equivalent crude protein from 
nonprotein nitrogen.
    (3) Adequate directions for use in accordance with the provisions in 
paragraph (d) of this section.

[43 FR 33708, July 1, 1978, as amended at 46 FR 49115, Oct. 6, 1981]



Sec. 573.460  Formaldehyde.

    The food additive formaldehyde may be safely used in the manufacture 
of animal feeds in accordance with the following conditions:
    (a) The additive is used, or intended for use, to improve the 
handling characteristics of fat by producing a dry, free-flowing 
product, as follows:
    (1) For animal fat in combination with certain oilseed meals, as a 
component of dry, nonpelletted feeds for beef and nonlactating dairy 
cattle.
    (i) An aqueous blend of soybean and sunflower meals in a ratio of 
3:1, respectively, is mixed with animal fat such that the oilseed meals 
and animal fat are in a ratio of 3:2. The feed ingredients are those 
defined by the ``Official Publication'' of the Association of American 
Feed Control Officials, Inc., 2003 ed., pp. 303, 308, and 309, which is 
incorporated by reference. The Director of the Office of the Federal 
Register approves this incorporation by reference in accordance with 5 
U.S.C. 552(a) and 1 CFR part 51. You may obtain copies from the 
Assistant Secretary-Treasurer, Association of American Feed Control 
Officials Inc., P.O. Box 478, Oxford, IN 47971, or you may examine a 
copy at the Division of Dockets Management, Food and Drug 
Administration, 5630 Fishers Lane, rm.

[[Page 563]]

1061, Rockville, MD 20852, or at the National Archives and Records 
Administration (NARA). For information on the availability of this 
material at NARA, call 202-741-6030, or go to: http://www.archives.gov/
federal_ register/code_of_federal _regulations/ibr_locations.html.
    (ii) Formaldehyde (37 percent solution) is added to the mixture at a 
level of 4 percent of the dry matter weight of the oilseed meals and 
animal fat. This mixture, upon drying, contains not more than 1 percent 
formaldehyde and not more than 12 percent moisture.
    (iii) To assure the safe use of the additive, in addition to the 
other information required by the Federal Food, Drug, and Cosmetic Act 
(the act), the label and labeling of the dried mixture shall bear:
    (A) The name of the additive.
    (B) Adequate directions for use providing that the feed as consumed 
does not contain more than 25 percent of the mixture.
    (2) For soybean and canola seeds and/or meals to which there may be 
added vegetable oil as a component of dry, nonpelleted feeds for beef 
and dairy cattle, including lactating dairy cattle.
    (i) An aqueous blend of oilseed and/or meals, with or without added 
vegetable oil, in a ratio such that, on a dry matter basis, the final 
protein level will be 25 to 35 percent and the fat content will be 20 to 
45 percent. The feed ingredients are those defined by the ``Official 
Publication'' of the Association of American Feed Control Officials, 
Inc., 2003 ed., pp. 301, 307, 308, and 309, which is incorporated by 
reference. The Director of the Office of the Federal Register approves 
this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 
CFR part 51. You may obtain copies from the Assistant Secretary-
Treasurer, Association of American Feed Control Officials Inc., P.O. Box 
478, Oxford, IN 47971, or you may examine a copy at the Division of 
Dockets Management, Food and Drug Administration, 5630 Fishers lane, rm. 
1061, Rockville, MD 20852, or at the National Archives and Records 
Administration (NARA). For information on the availability of this 
material at NARA, call 202-741-6030, or go to: http://www.archives.gov/
federal_ register/code_of_ federal_regulations/ibr_locations.html.
    (ii) Formaldehyde (37 percent solution) is added to the mixture at a 
level of 2.7 percent of the dry matter weight basis of the oilseeds and/
or meals and the vegetable oil. This mixture, upon drying, contains not 
more than 0.5 percent formaldehyde and not more than 12 percent 
moisture.
    (iii) To assure the safe use of the additive, in addition to the 
other information required by the act, the label and labeling of the 
dried mixture shall bear:
    (A) The name of the additive.
    (B) The statement, ``This supplement is not to exceed 12.5% of the 
total ration. Dietary calcium and magnesium levels should be considered 
when supplementing the diet with fat.''
    (C) The minimum and maximum levels of crude fat must be guaranteed 
and must be between -5 percent and +5 percent of the analyzed fat 
content for each batch.
    (b)(1) The food additive is formaldehyde (CAS No. 50-00-0; 37 
percent aqueous solution). It is used at a rate of 5.4 pounds (2.5 
kilograms) per ton of animal feed or feed ingredient. It is an 
antimicrobial agent used to maintain complete animal feeds or feed 
ingredients Salmonella negative for up to 21 days.
    (2) To assure safe use of the additive, in addition to the other 
information required by the Act, the label and labeling shall contain:
    (i) The name of the additive.
    (ii) A statement that formaldehyde solution which has been stored 
below 40 [deg]F or allowed to freeze should not be applied to complete 
animal feeds or feed ingredients.
    (iii) Adequate directions for use including a statement that 
formaldehyde should be uniformly sprayed on and thoroughly mixed into 
the complete animal feeds or feed ingredients and that the complete 
animal feeds or feed ingredients so treated shall be labeled as 
containing formaldehyde. The label must prominently display the 
statement: ``Treated with formaldehyde to maintain feed Salmonella 
negative. Use within 21 days.''
    (iv) The labeling for feed or feed ingredients to which formaldehyde 
has

[[Page 564]]

been added under the provisions of paragraph (b)(1) of this section is 
required to carry the following statement: ``Treated with formaldehyde 
to maintain feed Salmonella negative. Use within 21 days.''
    (3) To assure safe use of the additive, in addition to the other 
information required by the Act, the label and labeling shall contain:
    (i) Appropriate warnings and safety precautions concerning 
formaldehyde.
    (ii) Statements identifying formaldehyde as a poison with potentials 
for adverse respiratory effects.
    (iii) Information about emergency aid in case of accidental 
inhalation.
    (iv) Statements reflecting requirements of applicable sections of 
the Superfund Amendments and Reauthorization Act (SARA), and the 
Occupational Safety and Health Administration's (OSHA) human safety 
guidance regulations.
    (v) Contact address and phone number for reporting adverse reactions 
or to request a copy of the Materials Safety Data Sheet (MSDS).

[41 FR 38652, Sept. 10, 1976, as amended at 54 FR 18281, Apr. 28, 1989; 
61 FR 15704, Apr. 9, 1996; 63 FR 53580, Oct. 6, 1998; 68 FR 65633, Nov. 
21, 2003]



Sec. 573.480  Formic acid.

    The food additive, formic acid, may be safely used in accordance 
with the following conditions:
    (a) The additive is used as a preservative in hay crop silage in an 
amount not to exceed 2.25 percent of the silage on a dry weight basis or 
0.45 percent when direct cut, as follows:
    (1) The top foot of silage stored should not contain formic acid and
    (2) Silage should not be fed to livestock within 4 weeks of 
treatment.
    (b) The additive is used or intended for use as a feed acidifying 
agent, to lower the pH, in complete feed for swine and poultry at levels 
not to exceed 1.2 percent of the complete feed.
    (1) The additive consists of not less than 85 percent formic acid 
(CAS 64-18-6).
    (2) The additive meets the following specifications:
    (i) Free methyl alcohol not to exceed 1,000 parts per million (ppm);
    (ii) Methyl formate not to exceed 1,000 ppm; and
    (iii) Moisture not to exceed 15 percent.
    (3) To ensure safe use of the additive, formic acid and formate 
salts from all added sources cannot exceed 1.2 percent of complete feed 
when multiple sources of formic acid and its salts are used in 
combination.
    (4) To assure safe use of the additive, in addition to the other 
information required by the Federal Food, Drug and Cosmetic Act, the 
label and labeling shall contain:
    (i) The name of the additive.
    (ii) Adequate directions for use including a statement that formic 
acid must be uniformly applied and thoroughly mixed into complete feeds 
and that the complete feeds so treated shall be labeled as containing 
formic acid.
    (iii) Cautions for use including this statement: Caution: Follow 
label directions. Formic acid and formate salts from all added sources 
cannot exceed 1.2 percent of complete feed when multiple sources of 
formic acid and its salts are used in combination.
    (5) To ensure safe use of the additive, in addition to the other 
information required by the Federal Food, Drug, and Cosmetic Act and 
paragraph (b)(4) of this section, the label and labeling shall contain:
    (i) Appropriate warnings and safety precautions concerning formic 
acid (85 percent formic acid).
    (ii) Statements identifying formic acid (85 percent formic acid) as 
a corrosive and possible severe irritant.
    (iii) Information about emergency aid in case of accidental 
exposure.
    (A) Statements reflecting requirements of applicable sections of the 
Superfund Amendments and Reauthorization Act (SARA), and the 
Occupational Safety and Health Administration's (OSHA) human safety 
guidance regulations.
    (B) Contact address and telephone number for reporting adverse 
reactions or to request a copy of the Safety Data Sheet (SDS).

[76 FR 7106, Feb. 9, 2011, as amended at 82 FR 52209, Nov. 13, 2017; 83 
FR 20, Jan. 2, 2018; 83 FR 66618, Dec. 27, 2018]

[[Page 565]]



Sec. 573.490  Gamma-linolenic acid safflower meal.

    The food additive consists of the meal obtained after the removal of 
most of the oil from whole seeds or partially dehulled seeds or both 
obtained from a Carthamus tinctorius L. safflower Centennial variety 
genetically engineered to express the delta-6-desaturase gene from 
Saprolegnia diclina Humphrey. The 453 amino acid, delta-6-desaturase 
enzyme converts the fatty acid linoleic acid to gamma-linolenic acid 
during seed development. The resulting additive may be safely used in 
cattle and poultry feeds in accordance with the following prescribed 
conditions:
    (a) The additive shall contain not less than 20 percent crude 
protein, not more than 40 percent crude fiber, not more than 10 percent 
moisture, and not more than 2 percent crude fat.
    (b) The crude fat in the additive meets the following 
specifications:
    (1) Gamma-linolenic acid content not to exceed 55 percent.
    (2) Total content of stearidonic acid and cis, cis-6, 9-
octadecadienoic acid not to exceed a total of 0.5 percent.
    (3) Total content of palmitic, stearic, oleic, linoleic, and other 
associated fatty acids to exceed a total of 40 percent.
    (c) The additive is used or intended for use in cattle and poultry 
feeds as a source of protein in accordance with good manufacturing and 
feeding practices.
    (d) To assure safe use of the additive, in addition to the other 
information required by the Food, Drug, and Cosmetic Act, the label and 
labeling of the additive, any feed premix, or complete feed shall bear 
the following:
    (1) The name of the additive or the common name, safflower meal.
    (2) Adequate directions for use in cattle and poultry feeds.
    (e) The additive may be identified by the common or usual name, 
safflower meal.

[80 FR 35569, June 22, 2015]



Sec. 573.492  Gamma-linolenic acid safflower oil.

    The food additive, gamma-linolenic acid safflower oil, may be safely 
used in animal food as a source of gamma-linolenic acid and other omega-
6 fatty acids in accordance with the following conditions:
    (a) The additive is the oil obtained from whole seeds and/or 
partially dehulled seeds of a Carthamus tinctorius L. safflower 
Centennial variety genetically engineered to express the delta-6-
desaturase gene from Saprolegnia diclina Humphrey. The 453 amino acid, 
delta-6-desaturase enzyme converts the fatty acid linoleic acid to 
gamma-linolenic acid (all-cis-6,9,12-octadecatrienoic acid) during seed 
development.
    (1) The additive obtained from the seeds of the genetically 
engineered safflower Centennial variety may be blended with oil obtained 
from seeds of non-engineered oleic acid safflower varieties in order to 
meet the specifications required for the additive or the blend in 
paragraph (a)(2) of this section.
    (2) The additive or a safflower oil blend containing the additive 
for use in animal food meets the following specifications:
    (i) Crude fat content of the additive or the safflower oil blend is 
not less than 99.5 percent.
    (ii) Gamma-linolenic acid content is between 350 and 450 milligrams 
(mg) gamma-linolenic acid per gram of the additive or the safflower oil 
blend.
    (iii) Total content of stearidonic acid and cis, cis-6,9-
octadecadienoic acid in the additive or the safflower oil blend must not 
exceed a total of 0.3 percent.
    (b) Addition of the additive, or the safflower oil blend, to 
complete dry adult maintenance dog food must meet the following:
    (1) Addition of the additive or the safflower oil blend cannot 
provide more than 36 mg gamma-linolenic acid per kilogram body weight of 
the dog per day in more than 86 mg of the additive or the safflower oil 
blend. This maximum addition rate of the additive, or the safflower oil 
blend, is 0.3 percent of a complete dry adult maintenance dog food 
containing 3,600 kilocalories of metabolizable energy per kilogram of 
food as-fed.
    (2) Adjustments must be made for differing concentrations of gamma-
linolenic acid and for dog food formulas of different caloric density 
and/or that

[[Page 566]]

are fed to specific weights, breeds, or dogs of different activity 
levels to meet the requirements of this paragraph.
    (c) Addition of the additive, or the safflower oil blend, to 
complete dry adult maintenance cat food must meet the following:
    (1) Addition of the additive or the safflower oil blend cannot 
provide more than 33 mg gamma-linolenic acid per kilogram body weight of 
the cat per day in more than 79 mg of the additive or the safflower oil 
blend. This maximum addition rate of the additive, or the safflower oil 
blend, is 0.5 percent of a complete dry adult maintenance cat food 
containing 4,000 kilocalories of metabolizable energy per kilogram of 
food as-fed.
    (2) Adjustments must be made for differing concentrations of gamma-
linolenic acid and for cat food formulas of different caloric density 
and/or that are fed to specific weights, breeds, or cats of different 
activity levels to meet the requirements of this paragraph.
    (d) To assure safe use of the additive, in addition to other 
information required by the Federal Food, Drug, and Cosmetic Act, the 
label and labeling of the additive shall bear the following:
    (1) The name of the additive, gamma-linolenic acid safflower oil, or 
GLA safflower oil;
    (2) A guarantee for the minimum content of gamma-linolenic acid; and
    (3) Adequate directions for use such that the finished animal food 
complies with the provisions of paragraphs (b) and (c) of this section.

[84 FR 6675, Feb. 28, 2019]



Sec. 573.496  Guanidinoacetic acid.

    The food additive, guanidinoacetic acid, may be safely used in 
broiler chicken and turkey feeds in accordance with the following 
prescribed conditions:
    (a) The additive is manufactured by reacting glycine with cyanamide 
in an aqueous solution.
    (b) The additive is used or intended for use to spare arginine and 
as a precursor of creatine in broiler chicken and turkey feeds at levels 
not to exceed 0.12 percent of the complete feed.
    (c) The additive consists of not less than 97 percent 
guanidinoacetic acid [N-(aminoiminomethyl)-glycine] (CAS 352-97-6) by 
weight.
    (d) The additive meets the following specifications:
    (1) Dicyandiamide not to exceed 0.5 percent;
    (2) Cyanamide not to exceed 0.01 percent;
    (3) Melamine not to exceed 15 parts per million (ppm);
    (4) Sum of ammeline, ammelide, and cyanuric acid not to exceed 35 
ppm; and
    (5) Water not to exceed 1 percent.
    (e) To assure safe use of the additive in addition to the other 
information required by the Federal Food, Drug, and Cosmetic Act:
    (1) The label and labeling of the additive, any feed premix, and 
complete feed shall contain the name of the additive.
    (2) The label and labeling of the additive and any feed premix shall 
also contain:
    (i) A statement to indicate that the maximum use level of 
guanidinoacetic acid must not exceed 0.12 percent of the complete feed 
for broiler chickens and turkeys; and
    (ii) Adequate directions for use.

[81 FR 86269, Nov. 30, 2016]



Sec. 573.500  Condensed, extracted glutamic acid fermentation product.

    Condensed, extracted glutamic acid fermentation product may be 
safely used in animal feed under the following conditions:
    (a) The additive is a concentrated mixture of the liquor remaining 
from the extraction of glutamic acid, combined with the cells of 
Corynebacterium lilium used to produce the glutamic acid.
    (b) It is used or intended for use as follows:
    (1) In poultry feed as a source of protein in an amount not to 
exceed 5 percent of the total ration.
    (2) In cattle feed as a source of protein in an amount not to exceed 
10 percent of the feed.
    (c) In order to assure safe use, the label and labeling of the 
additive shall bear, in addition to the other information required by 
the Act, the following:
    (1) The name of the additive.

[[Page 567]]

    (2) A statement of the concentration of the additive contained in 
any mixture.
    (3) Adequate directions for use.



Sec. 573.520  Hemicellulose extract.

    Hemicellulose extract may be safely used in animal feed when 
incorporated therein in accordance with the following conditions:
    (a) The additive is produced from the aqueous extract obtained by 
the treatment of wood with water at elevated temperatures (325 degrees-
535 degrees F) and pressure (80 to 900 pounds per square inch) and 
contains primarily pentose and hexose sugars.
    (b) The additive may be used in a liquid or dry state with the 
liquid product containing not less than 55 percent carbohydrate and the 
dry product containing not less than 84 percent carbohydrate.
    (c) The additive is used as a source of metabolizable energy in 
animal feed in accordance with good manufacturing and feeding practices.

[41 FR 38652, Sept. 10, 1976, as amended at 43 FR 11181, Mar. 17, 1978]



Sec. 573.530  Hydrogenated corn syrup.

    (a) Identity. The product is produced by hydrogenation of corn syrup 
over a nickel catalyst.
    (b) Specifications. The product contains 70 percent hydrogenated 
corn syrup and a maximum of 0.5 percent reducing sugars.
    (c) Uses. The product is used as a humectant and plasticizer in 
preparation of soft-moist dog and cat foods.
    (d) Limitations. The product is preferably stored in a closed, 
stainless steel or aluminum container. The level of use of the product 
shall not exceed 15 percent of the total weight of the pet food 
formulation.
    (e) Labeling. The labeling shall bear, in addition to other 
information required by the Act:
    (1) The name of the additive.
    (2) Adequate directions for use in accordance with the provisions in 
paragraph (d) of this section.

[45 FR 22920, Apr. 4, 1980]



Sec. 573.540  Hydrolyzed leather meal.

    (a) Identity. Hydrolyzed leather meal is produced from leather 
scraps that are treated with steam for not less than 33 minutes at a 
pressure of not less than 125 pounds per square inch.
    (b) Specifications. The additive shall conform to the following 
percent-by-weight specifications:

Moisture, not less than 5 percent nor more than 10 percent.
Crude protein, not less than 60 percent.
Crude fat, not less than 5 percent.
Crude fiber, not more than 6 percent.
Chromium, not more than 2.75 percent.

    (c) Use. It is used or intended for use as a source of protein in 
swine feeds in an amount not to exceed 1.0 percent by weight of the 
finished feed.
    (d) Labeling. The labels and labeling shall bear, in addition to the 
other information required by the Act:
    (1) The name of the additive, hydrolyzed leather meal.
    (2) Adequate directions to provide finished feeds complying with 
paragraph (c) of this section.



Sec. 573.550  25-hydroxyvitamin D3.

    The food additive, 25-hydroxyvitamin D3, may be safely 
used in accordance with the following prescribed conditions:
    (a) The additive is used or intended for use as a source of vitamin 
D3 activity in animal feed or drinking water in accordance 
with good manufacturing and feeding practices as follows:
    (1) In feed or drinking water of layer and breeder chickens not to 
exceed 69 parts per billion (ppb) in feed or 34.5 ppb in drinking water.
    (2) In feed or drinking water of turkeys not to exceed:
    (i) 92 ppb in feed; or
    (ii) In drinking water, 25 ppb for turkeys up to 3 weeks of age, 36 
ppb for turkeys from 4 to 11 weeks of age, or 45 ppb for turkeys over 11 
weeks of age.
    (b) The additive consists of not less than 94 percent 25-
hydroxyvitamin D3 (9,10-secocholesta-5,7,10(19)-triene-
3[beta], 25-diol).
    (c) The additive meets the following specifications:
    (1) Not more than 1 percent of any individual sterol.
    (2) Not more than 5 percent water.

[[Page 568]]

    (3) Not more than 20 parts per million (ppm) lead.
    (4) Not more than 20 ppm aluminum.
    (5) Not more than 1.0 percent solvents and non-detectable levels of 
2[min], 4[min], 5[min], 7[min] tetraiodofluorescin.
    (6) Not more than 1 ppb 1, 25-dihydroxycholecalciferol.
    (d) To assure safe use of the additive, in addition to the other 
information required by the Federal Food, Drug, and Cosmetic Act, the 
label and labeling shall contain:
    (1) The name of the additive.
    (2) A statement to indicate the maximum use level of 25-
hydroxyvitamin D3 must not exceed 69 ppb in feed or 34.5 ppb 
in drinking water for layer and breeder chickens.
    (3) A statement to indicate for turkeys the maximum use level of 25-
hydroxyvitamin D3 must not exceed 92 ppb in feed; or in 
drinking water, 25 ppb for turkeys up to 3 weeks of age, 36 ppb for 
turkeys from 4 to 11 weeks of age, or 45 ppb for turkeys over 11 weeks 
of age.
    (4) Adequate use directions to ensure that 25-hydroxyvitamin 
D3 (and all premixes) is uniformly blended throughout the 
feed or drinking water.
    (5) An expiration date on all premix labeling.
    (6) A statement on all premix labeling (feed and drinking water 
forms) that 25-hydroxyvitamin D3 cannot be used 
simultaneously in both feed and water.

[83 FR 49486, Oct. 2, 2018]



Sec. 573.560  Iron ammonium citrate.

    Iron ammonium citrate may be safely used in animal feed in 
accordance with the following prescribed conditions:
    (a) The additive is the chemical green ferric ammonium citrate.
    (b) The additive is used or intended for use as an anticaking agent 
in salt for animal consumption so that the level of iron ammonium 
citrate does not exceed 25 parts per million (0.0025 percent) in the 
finished salt.
    (c) To assure safe use of the additive the label or labeling of the 
additive shall bear, in addition to the other information required by 
the Act:
    (1) The name of the additive.
    (2) Adequate directions to provide a final product that complies 
with the limitations prescribed in paragraph (b) of this section.



Sec. 573.580  Iron-choline citrate complex.

    Iron-choline citrate complex made by reacting approximately 
equimolecular quantities of ferric hydroxide, choline, and citric acid 
may be safely used as a source of iron in animal feed.



Sec. 573.600  Lignin sulfonates.

    Lignin sulfonates may be safely used in animal feeds in accordance 
with the following prescribed conditions:
    (a) For the purpose of this section, the food additive is either 
one, or a combination of, the ammonium, calcium, magnesium, or sodium 
salts of the extract of spent sulfite liquor derived from the sulfite 
digestion of wood or of abaca (Musa textilis) or of sisal (Agave 
sisalana) in either a liquid form (moisture not to exceed 50 percent by 
weight) or dry form (moisture not to exceed 6 percent by weight).
    (b) It is used or intended for use in an amount calculated on a dry 
weight basis, as follows:
    (1) As a pelleting aid in the liquid or dry form in an amount not to 
exceed 4 percent of the finished pellets.
    (2) As a binding aid in the liquid form in the flaking of feed 
grains in an amount not to exceed 4 percent of the flaked grain.
    (3) As a surfactant in molasses used in feeds, as liquid lignin 
sulfonate, in an amount not to exceed 11 percent of the molasses.
    (4) As a source of metabolizable energy, in the liquid or dry form, 
in an amount not to exceed 4 percent of the finished feed.



Sec. 573.615  Marine microalgae.

    The food additive, marine microalgae, may be safely used as a source 
of docosahexaenoic acid (DHA) and other omega-3 fatty acids in 
accordance with the following prescribed conditions:
    (a) The additive is dried whole cells of nonviable, nontoxigenic, 
nonpathogenic Schizochytrium sp. algae grown as a pure culture.
    (b) The additive is used in complete, dry adult maintenance food for 
dogs in

[[Page 569]]

accordance with good manufacturing and feeding practices not to exceed 
16.5 pounds per ton (7.5 kilograms (kg) per 1000 kg) of complete, dry, 
adult maintenance dog food.
    (c) The additive consists of not less than 17.0 percent 
(4Z,7Z,10Z,13Z,16Z,19Z)-docosa-4,7,10,13,16,19-hexaenoic acid 
(docosahexaenoic acid or DHA).
    (d) The additive meets the following specifications:
    (1) Not less than 40 percent crude fat;
    (2) Not more than 12 percent ash;
    (3) Not more than 8 percent unsaponifiable matter;
    (4) Not more than 5 percent insoluble impurities;
    (5) Not more than 5 percent free fatty acids; and
    (6) Not more than 6 percent water.
    (e) To ensure the safe use of the additive, in addition to other 
information required by the Federal Food, Drug, and Cosmetic Act:
    (1) The label and labeling of the additive, any feed premix, and 
complete feed, shall contain the name of the additive, marine 
microalgae.
    (2) The label and labeling of the additive and any feed premix shall 
also contain:
    (i) A statement to indicate that the maximum use level of the 
additive shall not exceed 16.5 pounds per ton (7.5 kg per 1000 kg) of 
complete, dry, adult maintenance dog food.
    (ii) Adequate directions for use.

[83 FR 19935, May 7, 2018]



Sec. 573.620  Menadione dimethylpyrimidinol bisulfite.

    The food additive, menadione dimethylpyrimidinol bisulfite, may be 
safely used in accordance with the following conditions:
    (a) The additive is the 2-hydroxy-4,6-dimethylpyrimidinol salt of 
menadione 
(C17H18O6N2
S).
    (b) The additive is used or intended for use as a nutritional 
supplement for the prevention of vitamin K deficiency as follows:
    (1) In chicken and turkey feed at a level not to exceed 2 grams per 
ton of complete feed.
    (2) In the feed of growing and finishing swine at a level not to 
exceed 10 grams per ton of feed.
    (c) To assure safe use, the label and labeling of the additive shall 
bear adequate directions for use.



Sec. 573.625  Menadione nicotinamide bisulfite.

    The food additive may be safely used as follows:
    (a) The additive is 1,2,3,4-tetrahydro-2-methyl-1,4-dioxo-2-
naphthalene sulfonic acid with 3-pyridine carboxylic acid amine (CAS No. 
73581-79-0).
    (b) The additive is used or intended for use as a nutritional 
supplement for both the prevention of vitamin K deficiency and as a 
source of supplemental niacin as follows:
    (1) In chicken and turkey feeds at a level not to exceed 2 grams per 
ton of complete feed.
    (2) In growing and finishing swine feeds at a level not to exceed 10 
grams per ton of complete feed.
    (c) To assure safe use, the label and labeling of the additive shall 
bear adequate directions for use.

[64 FR 46840, Aug. 27, 1999]



Sec. 573.637  Methyl esters of conjugated linoleic acid (cis-9, 
trans-11 and trans-10, cis-12-octadecadienoic acids).

    The food additive, methyl esters of conjugated linoleic acid (cis-9, 
trans-11 and trans-10, cis-12 octadecadienoic acids), may be safely used 
in swine feed in accordance with the prescribed conditions:
    (a) The food additive is manufactured by the reaction of refined 
sunflower oil with methanol to produce fatty acid methyl esters, which 
then undergo conjugation to yield methyl esters of octadecadienoic acid. 
The additive consists of not less than 28 percent methyl ester of cis-9, 
trans-11-octadecadienoic acid, and not less than 28 percent methyl ester 
of trans-10, cis-12-octadecadienoic acid with the sum of the other 
methyl esters of octadecadienoic acid not to exceed 4 percent. The 
additive shall contain not less than 35 percent of other fatty acid 
esters composed of oleic acid, palmitic acid, stearic acid, linoleic 
acid, and other associated acid esters.
    (b) The additive is used or intended for use in the feed of growing 
and finishing swine as a source of fatty acids

[[Page 570]]

at levels not to exceed 0.6% in the finished feed.
    (c) The additive meets the following specifications:
    (1) Free methyl alcohol not to exceed 0.015%.
    (2) Insoluble impurities not to exceed 0.1%.
    (3) Moisture not to exceed 0.5%.
    (4) Unsaponifiable matter not to exceed 1.0%.
    (d) To assure safe use of the additive, in addition to the other 
information required by the act:
    (1) The label and labeling of the additive and any feed premix shall 
bear the following:
    (i) The name of the additive.
    (ii) A statement to indicate that methyl esters of conjugated 
linoleic acid (cis-9, trans-11 and trans-10, cis-12 octadecadienoic 
acids) must not be added to vitamin or mineral premixes.
    (2) The label and labeling of the additive, any feed premix, or 
complete feed prepared therefrom shall bear adequate directions for use.

[73 FR 64198, Oct. 29, 2008]



Sec. 573.640  Methyl esters of higher fatty acids.

    The food additive methyl esters of higher fatty acids may be safely 
used in animal feeds in accordance with the following prescribed 
conditions:
    (a) The food additive is manufactured by reaction of methyl alcohol 
with feed-grade fats or oils and consists of not less than 70 percent 
methyl esters of the following straight-chain monocarboxylic acids: 
Docosahexanoic acid, eicosapentanoic acid, linoleic acid, myristic acid, 
oleic acid, palmitic acid, palmitoleic acid, and stearic acid, and 
lesser amounts of the associated acid esters.
    (b) The food additive meets the following specifications:
    (1) Free methyl alcohol not to exceed 150 parts per million.
    (2) Unsaponifiable matter not to exceed 2 percent.
    (3) It is free of chick-edema factor or other factors toxic to 
chicks, as evidenced during the bioassay method for determining the 
chick-edema factor as prescribed in paragraph (b)(4)(ii) of this 
section.
    (4) For the purposes of this section:
    (i) Unsaponifiable matter shall be determined by the method 
described in Section 28.081, ``Unsaponifiable Residue (20)--Official 
Final Action'' of the ``Official Methods of Analysis of the Association 
of Official Analytical Chemists,'' 13th Ed., 1980, p. 451, which is 
incorporated by reference. Copies are available from the AOAC 
INTERNATIONAL, 481 North Frederick Ave., suite 500, Gaithersburg, MD 
20877, or available for inspection at the National Archives and Records 
Administration (NARA). For information on the availability of this 
material at NARA, call 202-741-6030, or go to: http://www.archives.gov/
federal_ register/code_of_ federal_regulations/ibr_locations.html.
    (ii) The chick-edema factor bioassay method described under ``26. 
Oils, Fats, and Waxes'' in the Journal of the Association of Official 
Agricultural Chemists, Vol. 44, Page 146 (1961), or the method described 
under ``Chick-Edema Factor--Bioassay Method (34)--Official Final 
Action'' in Sec. Sec. 28.113-28.117, ``Official Methods of Analysis of 
the Association of Official Analytical Chemists,'' 12th Ed., 1975, pp. 
509-511, which is incorporated by reference, shall be employed. (Copies 
of the methods are available from the AOAC INTERNATIONAL, 481 North 
Frederick Ave., suite 500, Gaithersburg, MD 20877, or available for 
inspectionat the National Archives and Records Administration (NARA). 
For information on the availability of this material at NARA, call 202-
741-6030, or go to: http://www.archives.gov/federal_ register/code_of_ 
federal_regulations/ibr_locations.html. ) The presence of chick-edema 
factor shall be determined by a comparison between the mean log of the 
pericardial fluid volumes of a test group and of a concurrent negative 
control group. The significance of the difference in pericardial fluid 
volumes between the test group and the negative control group is 
determined by calculating a ``t'' value according to the formula:
[GRAPHIC] [TIFF OMITTED] TR01JA93.412

where:


[[Page 571]]


xt and xc are the means of the logs of the pericardial fluid volumes of 
          the test and control groups, respectively;
nt and nc are the number of chicks in the respective groups;
st\2\ and sc\2\ are the variances of the test and control groups, 
          respectively.
The variances are calculated as follows:
[GRAPHIC] [TIFF OMITTED] TR01JA93.413

where:

[Sigma]x is the sum of the logs of the pericardial fluid volumes;
[Sigma]x\2\ is the sum of the squares of the logs of the pericardial 
          fluid volumes for either the test t or control c group data.


The test sample is judged to contain chick-edema factor if the 
calculated ``t'' exceeds +1.3 and the mean log of the pericardial fluid 
volume obtained from the negative control group multiplied by 100 is 
less than 1.1461.
    (iii) ``Other factors toxic to chicks'' referred to in paragraph 
(b)(3) of this section shall be determined during the course of the 
bioassay test described in paragraph (b)(4)(ii) of this section, on the 
basis of chick deaths or other abnormalities not attributable to chick-
edema factor or to the experimental conditions of the test.
    (c) It is used or intended for use as a supplementary source of fat 
for animal feed.
    (d) To assure safe use of the additive, in addition to the other 
information required by the act:
    (1) The label and labeling of the additive, and any feed additive 
supplement, feed additive concentrate, feed additive premix, or complete 
feed prepared therefrom shall bear:
    (i) The name of the additive.
    (ii) The designation ``feed grade'' in juxtaposition with the name 
and equally as prominent.
    (2) The label or labeling of the additive and any feed additive 
supplement, feed additive concentrate, feed additive premix, or complete 
feed prepared therefrom shall bear adequate directions for use.

[41 FR 38652, Sept. 10, 1976, as amended at 47 FR 9397, Mar. 5, 1982; 54 
FR 18281, Apr. 28, 1989; 70 FR 40880, July 15, 2005; 70 FR 67651, Nov. 
8, 2005]



Sec. 573.660  Methyl glucoside-coconut oil ester.

    Methyl glucoside-coconut oil ester may be safely used in accordance 
with the following conditions:
    (a) The additive meets the specifications prescribed in Sec. 
172.816 of this chapter.
    (b) It is used as a surfactant in molasses intended for use in 
animal feed at a level not to exceed 320 parts per million.



Sec. 573.680  Mineral oil.

    Mineral oil may be safely used in animal feed, subject to the 
provisions of this section.
    (a) Mineral oil, for the purpose of this section, is that complying 
with the definition and specifications contained in Sec. 172.878 (a) 
and (b) or in Sec. 178.3620(b)(1) (i) and (ii) of this chapter.
    (b) It is used in animal feeds for the following purposes:
    (1) To reduce dustiness of feeds or mineral supplements.
    (2) To serve as a lubricant in the preparation of pellets, cubes, or 
blocks and to improve resistance to moisture of such pellets, cubes, or 
blocks.
    (3) To prevent the segregation of trace minerals in mineralized 
salt.
    (4) To serve as a diluent carrier in the manufacture of feed grade 
biuret in accordance with good manufacturing practice.
    (5) For the removal of water from substances intended as ingredients 
of animal feed.
    (c) The quantity of mineral oil used in animal feed shall not exceed 
3.0 percent in mineral supplements, nor shall it exceed 0.06 percent of 
the total ration when present in feed or feed concentrates.

[41 FR 38652, Sept. 10, 1976, as amended at 47 FR 41106, Sept. 17, 1982]



Sec. 573.685  Natamycin.

    The food additive natamycin (CAS No. 7681-93-8) may be safely used 
in broiler chicken feeds in accordance with the following 
specifications:
    (a) The additive is a stereoisomer of 22-[(3-amino-3,6,dideoxy-
[beta]-D-mannopyranosyl)oxy]-1,3,26-trihydroxy-12-methyl-10-oxo-6,11,28-
trioxatricyclo[22.3.1.0\5\, \7\] octacosa-

[[Page 572]]

8,14,16,18,20-pentaene-25-carboxylic acid with the empirical formula 
C33H47NO13.
    (b) The additive shall conform to U.S.P. specifications.
    (c) The additive (as part of a premix composed of calcium carbonate, 
natamycin, and lactose) is used for retarding the growth of Aspergillus 
parasiticus in broiler chicken feeds for up to 14 days after the 
addition of natamycin.
    (d) Each pound (454 grams (g)) of the premix shall contain 434 (g) 
of calcium carbonate, 10 g of natamycin activity, and 10 g of lactose. 
The premix shall be mixed into broiler chicken feed at the rate of 1 
pound (0.454 kilograms (kg)) per ton (908 kg) of feed to provide 
natamycin at a level of 11 parts per million (ppm). The premix shall be 
thoroughly mixed into the dry components of the broiler chicken feed 
before adding the liquid components. Broiler feeds to which the 
natamycin premix is added shall be used within 4 weeks of addition of 
the premix.
    (e) To assure the safe use of the additive, the label or labeling of 
the additive shall bear, in addition to other information required by 
the Federal Food, Drug, and Cosmetic Act, the following:
    (1) The name and CAS number of the additive, and its purpose.
    (2) A listing of ingredients consisting of calcium carbonate, the 
additive, and lactose and their proportions in the premix as prescribed 
under paragraph (d) of this section.
    (3) Adequate directions for use to ensure a broiler chicken feed 
that is in compliance with the limitations prescribed in paragraph (d) 
of this section.
    (4) An appropriate cautionary statement: ``Caution: Store in a 
tightly-closed, light-resistant container in a cool, dry place.''
    (5) An expiration date of 1 year from the date of manufacture.
    (6) A contact address and telephone number for reporting adverse 
reactions experienced by users, or to request a copy of the Material 
Safety Data Sheet for natamycin.

[69 FR 19321, Apr. 13, 2004]



Sec. 573.696  Feed grade sodium formate.

    The food additive, feed grade sodium formate, may be safely used in 
the manufacture of complete swine and poultry feeds in accordance with 
the following prescribed conditions:
    (a) The additive is manufactured by the reaction of 99 percent 
formic acid and 50 percent sodium hydroxide in water to produce a 
solution made up of at least 20.5 percent sodium salt of formic acid and 
not more than 61 percent formic acid.
    (b) The additive is used or intended for use as a feed acidifying 
agent, to lower the pH, in complete swine and poultry feeds at levels 
not to exceed 1.2 percent of the complete feed.
    (c) To assure safe use of the additive, formic acid and formate 
salts from all added sources cannot exceed 1.2 percent of complete feed 
when multiple sources of formic acid and its salts are used in 
combination.
    (d) To assure safe use of the additive, in addition to the other 
information required by the Federal Food, Drug, and Cosmetic Act, the 
label and labeling shall contain:
    (1) The name of the additive.
    (2) Adequate directions for use, including a statement that feed 
grade sodium formate must be uniformly applied and thoroughly mixed into 
complete feeds and that the complete feeds so treated shall be labeled 
as containing feed grade sodium formate.
    (3) Cautions for use including this statement: Caution: Follow label 
directions. Formic acid and formate salts from all added sources cannot 
exceed 1.2 percent of complete feed when multiple sources of formic acid 
and its salts are used in combination.
    (e) To assure safe use of the additive, in addition to the other 
information required by the act and paragraph (d) of this section, the 
label and labeling shall contain:
    (1) Appropriate warnings and safety precautions concerning feed 
grade sodium formate.
    (2) Statements identifying feed grade sodium formate as a corrosive 
and possible severe irritant.
    (3) Information about emergency aid in case of accidental exposure 
as follows:
    (i) Statements reflecting requirements of applicable sections of the

[[Page 573]]

Superfund Amendments and Reauthorization Act (SARA), and the 
Occupational Safety and Health Administration (OSHA) human safety 
guidance regulations.
    (ii) Contact address and telephone number for reporting adverse 
reactions or to request a copy of the Material Safety Data Sheet (MSDS).

[81 FR 67154, Sept. 30, 2016, as amended at 81 FR 95027, Dec. 27, 2016]



Sec. 573.700  Sodium nitrite.

    Sodium nitrite may be safely used in canned pet food containing meat 
and fish in accordance with the following prescribed conditions:
    (a) It is used or intended for use alone as a preservative and color 
fixative in canned pet food containing fish, meat, and fish and meat 
byproducts so that the level of sodium nitrite does not exceed 20 parts 
per million.
    (b) To assure safe use of the additive, in addition to the other 
information required by the act:
    (1) The label of the additive shall bear:
    (i) The name of the additive.
    (ii) A statement of the concentration of the additive in any 
mixture.
    (2) The label or labeling shall bear adequate directions to provide 
a final product that complies with the limitations prescribed in 
paragraph (a) of this section.



Sec. 573.720  Petrolatum.

    Petrolatum may be safely used in or on animal feed, subject to the 
following prescribed conditions:
    (a) Petrolatum complies with the specifications set forth in the 
U.S. Pharmacopeia XVI for white petrolatum or in The National Formulary 
XII for yellow petrolatum.
    (b) Petrolatum meets the following ultraviolet absorbance limits 
when subjected to the analytical procedure described in Sec. 172.886(b) 
of this chapter.

    Ultraviolet absorbance per centimeter path length:

------------------------------------------------------------------------
                        Millimicrons                            Maximum
------------------------------------------------------------------------
280 to 289..................................................        0.25
290 to 299..................................................         .20
300 to 359..................................................         .14
360 to 400..................................................         .04
------------------------------------------------------------------------

    (c) It is used in animal feed for the following purposes:
    (1) To reduce dustiness of feeds or mineral supplements.
    (2) To serve as a lubricant in the preparation of pellets, cubes, or 
blocks, and to improve resistance to moisture of such pellets, cubes, or 
blocks.
    (d) The quantity of petrolatum present in animal feeds from the uses 
specified in paragraph (c) of this section shall not exceed 3 percent in 
mineral supplements nor shall it exceed 0.06 percent of the total ration 
when present in feed or feed concentrates.
    (e) When used in combination with technical white mineral oil for 
the uses described in paragraph (c) of this section, the total quantity 
of combined petrolatum and technical white mineral oil shall not exceed 
the limits prescribed in paragraph (d) of this section.
    (f) Petrolatum may contain any antioxidant permitted in food by 
regulations issued in accordance with section 409 of the act, in an 
amount not greater than that required to produce its intended effect.



Sec. 573.740  Odorless light petroleum hydrocarbons.

    Odorless light petroleum hydrocarbons complying with Sec. 
172.884(a) and (b) of this chapter may be safely used in an amount not 
in excess of that required as a component of insecticide formulations 
used in compliance with regulations issued in this part.



Sec. 573.750  Pichia pastoris dried yeast.

    (a) Identity. The food additive Pichia pastoris dried yeast may be 
used in feed formulations of broiler chickens as a source of protein not 
to exceed 10 percent by weight of the total formulation.
    (b) Specifications. The additive shall conform to the following 
percent-by-weight specifications:
    (1) Crude protein, not less than 60 percent.
    (2) Crude fat, not less than 2 percent.
    (3) Crude fiber, not more than 2 percent.
    (4) Ash, not more than 13 percent.
    (5) Moisture, not more than 6 percent.

[[Page 574]]

    (c) Use. To ensure safe use, the labeling of the additive and any 
feed additive supplement, concentrate, or premix prepared therefrom 
shall bear, in addition to other required information, the name of the 
additive, directions for use to provide not more than 10 percent by 
weight of the total ration, and the statement ``Caution: Not to be used 
in layers or other poultry intended for breeding.''

[58 FR 59170, Nov. 8, 1993]



Sec. 573.760  Poloxalene.

    The food additive poloxalene may be safely used in accordance with 
the following prescribed conditions:
    (a) The additive consists of polyoxy-propylene-polyoxyethylene 
glycol non-ionic block polymer meeting the following specifications:
    (1) Molecular weight range: 2,850-3,150.
    (2) Hydroxyl number: 35.7-39.4.
    (3) Cloud point (10 percent solution): 42 [deg]C-46 [deg]C.
    (4) Structural formula:
    [GRAPHIC] [TIFF OMITTED] TR01JA93.414
    
    (b) In feed as a surfactant for the flaking of feed grains when 
added to liquid grain conditioner in an amount not to exceed 1.0 percent 
of the conditioner. The conditioner is added to the feed at a rate of 1 
quart per ton of feed.
    (c) The label and labeling shall bear, in addition to the other 
information required by the Act:
    (1) The name of the additive.
    (2) Adequate directions and warnings for use.



Sec. 573.780  Polyethylene.

    (a) Identity. Polyethylene consists of basic polymers manufactured 
by the catalytic polymerization of ethylene.
    (b) Specifications. (1) For the purposes of this section, 
polyethylene shall meet the specifications in item 2.1 of Sec. 
177.1520(c) of this chapter.
    (2) The polyethylene is designed in a pellet form in a configuration 
presenting maximum angular surface having the following dimensions in 
centimeters:

0.9 0.1 x 0.8 0.1 x 1.2 
          0.1

    (c) Use. It is used as a replacement for roughage in feedlot rations 
for finishing slaughter cattle.
    (d) Labeling. The labels and labeling shall bear in addition to the 
other information required by the Act:
    (1) The name of the additive ``polyethylene roughage replacement.''
    (2) Adequate directions for use which shall provide for the 
administration of one-half pound of polyethylene pellets per head per 
day for 6 successive days. All natural roughage should be removed for a 
minimum of 12 hours prior to administration of polyethylene roughage 
replacement. Roughage replacement must be adequately mixed in the ration 
for uniform distribution.

[41 FR 38652, Sept. 10, 1976, as amended at 54 FR 18282, Apr. 28, 1989]



Sec. 573.800  Polyethylene glycol (400) mono- and dioleate.

    (a) The food additive polyethylene glycol (400) mono- and dioleate 
meets the following specifications: Saponification number, 80-88; acid 
number, 5.0 maximum; and average molecular weight range, 640-680.
    (b) It is used as a processing aid in the production of animal feeds 
when present as a result of its addition to molasses in an amount not to 
exceed 250 parts per million of the molasses.



Sec. 573.820  Polyoxyethylene glycol (400) mono- and dioleates.

    The food additive polyoxyethylene glycol (400) mono- and dioleates 
may be safely used as an emulsifier in calf-milk replacer formulations.



Sec. 573.840  Polysorbate 60.

    The food additive polysorbate 60 (polyoxyethylene (20) sorbitan 
monostearate) may be safely used in animal feeds in accordance with the 
following prescribed conditions:
    (a) It is used alone or in combination with sorbitan monostearate as 
an emulsifier in mineral premixes and dietary supplements for animal 
feeds.
    (b) It is used as an emulsifier in milk-replacer formulations for 
calves.

[[Page 575]]



Sec. 573.860  Polysorbate 80.

    The food additive polysorbate 80 (polyoxyethylene (20) sorbitan 
monooleate) may be safely used as an emulsifier in milk-replacer 
formulations for calves.



Sec. 573.870  Poly(2-vinylpyridine-co-styrene).

    The food additive poly(2-vinylpyridine-co-styrene) may be safely 
used as nutrient protectant in feed for beef cattle and dairy cattle and 
replacement dairy heifers when used in accordance with the following 
conditions:
    (a) The additive meets the following specifications:

------------------------------------------------------------------------
            Component/property                       Limitation
------------------------------------------------------------------------
Inherent viscosity........................  1.0-1.6 deciliter per
                                             gram.\1\
Styrene moiety............................  40 percent maximum.
2-Vinylpyridine moiety....................  90 percent maximum.
Residual styrene..........................  200 parts per billion
                                             maximum.
Residual 2-vinylstyrene...................  200 parts per billion
                                             maximum.
Heavy metals such as lead.................  10 parts per million
                                             maximum.
Arsenic...................................  3 parts per million maximum.
------------------------------------------------------------------------
\1\ Inherent viscosity of a 0.25 percent (weight/volume) solution in
  dimethylformamide.

    (b) The additive is used in the manufacture of rumen-stable, 
abomasum-dispersible nutrient(s) for beef cattle and dairy cattle and 
replacement dairy heifers such that the maximum use of the additive from 
all sources does not exceed 5.1 grams per head per day. The additive may 
be used to protect the following nutrients:
    (1) Methionine. The resulting product must contain a maximum of 10 
percent poly(2-vinylpyridine-co-styrene) by weight and a minimum of 55 
percent methionine by weight. The coated methionine must be established 
through in vitro tests to be at least 90 percent rumen-stable, of which 
at least 90 percent is subsequently dispersible under abomasal 
conditions.
    (2) Methionine and lysine. The resulting product must contain a 
maximum of 10 percent poly(2-vinylpyridine-co-styrene) by weight and a 
minimum of a combined total of 55 percent methionine and lysine by 
weight. The coated methionine and lysine must be established through in 
vitro tests to be at least 90 percent rumen-stable, of which at least 90 
percent is subsequently dispersible under abomasal conditions.
    (c) Label and labeling. To ensure safe use of the additive, the 
label and labeling of the additive and of any feed additive supplement, 
feed additive concentrate, feed additive premix, or liquid feed 
supplement prepared therefrom, shall bear, in addition to the other 
information required by the Federal Food, Drug, and Cosmetic Act, the 
following:
    (1) The name of the additive.
    (2) A statement of the concentration of poly(2-vinylpyridine-co-
styrene) in any product or mixture.
    (3) Adequate directions for the use of the rumen-stable, abomasum-
dispersible nutrient(s) products.
    (4) The following statement: ``Warning: Maximum use of poly(2-
vinylpyridine-co-styrene) from all sources is not to exceed 5.1 grams 
per head per day.''

[57 FR 7875, Mar. 5, 1992, as amended at 57 FR 24187, June 8, 1992; 61 
FR 11547, Mar. 21, 1996; 70 FR 13100, Mar. 18, 2005]



Sec. 573.880  Normal propyl alcohol.

    Normal propyl alcohol may be safely used in feeds and feed 
supplements for cattle as a source of metabolizable energy. It is 
incorporated in the feed or feed supplement in an amount which provides 
not more than 54.5 grams of the additive per head per day.



Sec. 573.900  Pyrophyllite.

    Pyrophyllite (aluminum silicate monohydrate) may be safely used as 
the sole anticaking aid, blending agent, pelleting aid, or carrier in 
animal feed when incorporated therein in an amount not to exceed 2 
percent in complete animal feed.



Sec. 573.914  Salts of volatile fatty acids.

    (a) Identity. The food additive is a blend containing the ammonium 
or calcium salt of isobutyric acid and the ammonium or calcium salts of 
a mixture of 5-carbon acids--isovaleric, 2-methylbutyric, and n-valeric.
    (b) Specifications. The additive contains ammonium or calcium salts 
of volatile fatty acids and shall conform to the following 
specifications:
    (1) Ammonium salts:

[[Page 576]]



------------------------------------------------------------------------
                Components                             Amount
------------------------------------------------------------------------
Ammonium salts of mixed 5-carbon acids (as  48 to 54 percent.
 identified in paragraph (a) of this
 section).
Ammonium salt of isobutyric acid..........  22 to 26 percent.
Water.....................................  28 percent maximum.
Ammonia...................................  0.3 percent maximum.
Arsenic...................................  3 parts per million maximum.
Heavy metals such as lead.................  10 parts per million
                                             maximum.
------------------------------------------------------------------------

    (2) Calcium salts:

------------------------------------------------------------------------
                Components                             Amount
------------------------------------------------------------------------
Calcium salts of mixed 5-carbon acids (as   58 to 72 percent.
 identified in paragraph (a) of this
 section).
Calcium salt of isobutyric acid...........  26 to 34 percent.
Calcium hydroxide.........................  3 percent maximum.
Water.....................................  14 percent maximum.
Arsenic...................................  3 parts per million maximum.
Heavy metals such as lead.................  10 parts per million
                                             maximum.
------------------------------------------------------------------------

    (c) Use. The additive is used or intended for use as a source of 
energy in dairy cattle feed.
    (d) Labeling. The label and labeling of the additive in any feed, 
feed supplement, feed concentrate, feed premix, or liquid feed 
supplement prepared therefrom shall bear, in addition to other 
information required by the act, the following:
    (1) The name of the additive.
    (2) Adequate directions for use, including statements expressing 
maximum use levels. For ammonium salts of volatile fatty acids, the 
statements: ``Not to exceed 160 grams per head per day thoroughly mixed 
in dairy cattle feed as a source of energy.'' For calcium salts of 
volatile fatty acids, the statement: ``Not to exceed 135 grams per head 
per day thoroughly mixed in dairy cattle feed as a source of energy.''

[49 FR 45125, Nov. 15, 1984; 50 FR 8606, Mar. 4, 1985, as amended at 70 
FR 13100, Mar. 18, 2005]



Sec. 573.920  Selenium.

    (a) Public Law 103-354 enacted October 13, 1994 (the 1994 Act), 
states that FDA shall not implement or enforce the final rule issued on 
September 13, 1993 (58 FR 47962), in which FDA stayed the 1987 
amendments and any modification of such rule issued after enactment of 
the 1994 Act; unless the Commissioner of Food and Drugs makes a 
determination that:
    (1) Selenium additives are not essential at levels authorized in the 
absence of such final rule, to maintain animal nutrition and protect 
animal health;
    (2) selenium at such levels is not safe to the animals consuming the 
additive;
    (3) selenium at such levels is not safe to individuals consuming 
edible portions of animals that receive the additive;
    (4) selenium at such levels does not achieve its intended effect of 
promoting normal growth and reproduction of livestock and poultry; and
    (5) the manufacture and use of selenium at such levels cannot 
reasonably be controlled by adherence to current good manufacturing 
practice requirements.
    (6) Paragraphs (b) through (g) of this section provide the currently 
acceptable levels of selenium supplementation.
    (b) The food additive selenium is a nutrient administered in animal 
feed as sodium selenite or sodium selenate as provided in paragraph (c) 
of this section, as a controlled-release sodium selenite bolus as 
provided in paragraph (f) of this section, as selenium yeast as provided 
in paragraph (g) of this section, or as selenomethionine hydroxy 
analogue as provided in paragraph (h) of this section.
    (c) Selenium, as sodium selenite or sodium selenate, is added to 
feed as follows:
    (1) In complete feed for chickens, swine, turkeys, sheep, cattle, 
and ducks at a level not to exceed 0.3 part per million.
    (2) In feed supplements for limit feeding as follows:
    (i) Sheep: At a level not to exceed an intake of 0.7 milligram per 
head per day.
    (ii) Beef cattle: At a level not to exceed an intake of 3 milligrams 
per head per day.
    (3) In salt-mineral mixtures for free-choice feeding as follows:
    (i) Sheep: Up to 90 parts per million in a mixture for free-choice 
feeding at a rate not to exceed an intake of 0.7 milligram per head per 
day.
    (ii) Beef cattle: Up to 120 parts per million in a mixture for free-
choice

[[Page 577]]

feeding at a rate not to exceed an intake of 3 milligrams per head per 
day.
    (4) The additive, as sodium selenite or sodium selenate, shall be 
incorporated into feed as follows:
    (i) It shall be incorporated into each ton of complete feed by 
adding no less than 1 pound of a premix containing no more than 272.4 
milligrams of added selenium per pound.
    (ii) It shall be incorporated into each ton of salt-mineral mixture 
for sheep or beef cattle from a premix containing no more than 4.5 grams 
of added selenium per pound.
    (5) Usage of the additive must conform to the requirements of 
paragraphs (d) and (e) of this section.
    (d) The premix manufacturer shall follow good manufacturing 
practices in the production of selenium premixes. Inventory, production, 
and distribution records must provide a complete and accurate history of 
product production. Production controls must assure products to be what 
they are purported and labeled. Production controls shall include 
analysis sufficient to adequately monitor quality.
    (e) The label or labeling of any selenium premix shall bear adequate 
directions and cautions for use including this statement: ``Caution: 
Follow label directions. The addition to feed of higher levels of this 
premix containing selenium is not permitted.''
    (f) The additive is orally administered to beef and dairy cattle as 
an osmotically controlled, constant release bolus containing sodium 
selenite. Each bolus contains 360 milligrams of selenium as sodium 
selenite, and delivers 3 milligrams of selenium per day for 120 days. To 
ensure safe use of the additive:
    (1) The osmotically controlled, constant release bolus is for use 
only in beef and dairy cattle more than 3 months of age or over 200 
pounds body weight.
    (2) Only one bolus containing 360 milligrams of selenium as sodium 
selenite is administered orally to each animal in 120 days.
    (3) The labeling shall bear the following: ``This bolus delivers the 
maximum daily allowable amount of selenium and shall be the sole source 
of supplementation. Do not use in areas containing excess selenium. Do 
not rebolus within 4 months.''
    (g) Selenium yeast is a dried, non-viable yeast (Saccharomyces 
cerevisiae) cultivated in a fed-batch fermentation which provides 
incremental amounts of cane molasses and selenium salts in a manner 
which minimizes the detrimental effects of selenium salts on the growth 
rate of the yeast and allows for optimal incorporation of inorganic 
selenium into cellular organic material. Residual inorganic selenium is 
eliminated in a rigorous washing process and must not exceed 2 percent 
of the total selenium content in the final selenium yeast product.
    (1) Selenium, as selenium yeast, is added to feed as follows:
    (i) In complete feed for chickens, turkeys, swine, beef cattle, and 
dairy cattle at a level not to exceed 0.3 part per million.
    (ii) In feed supplements for limit feeding for beef cattle at a 
level not to exceed an intake of 3 milligrams per head per day.
    (iii) In salt-mineral mixtures for free-choice feeding for beef 
cattle up to 120 parts per million in a mixture for free-choice feeding 
at a rate not to exceed an intake of 3 milligrams per head per day.
    (2) Guaranteed organic selenium content from selenium yeast must be 
declared on the selenium yeast product label.
    (3) The additive, as selenium yeast, shall be incorporated into feed 
as follows:
    (i) It shall be incorporated into each ton of complete feed by 
adding no less than 1 pound of a premix containing no more than 272.4 
milligrams of added selenium per pound.
    (ii) It shall be incorporated into each ton of salt-mineral mixture 
for beef cattle from a premix containing no more than 4.5 grams of added 
selenium per pound.
    (4) Usage of this additive must conform to the requirements of 
paragraphs (d) and (e) of this section.
    (h) Selenomethionine hydroxy analogue [R,S-2-hydroxy-4-
methylselenobutanoic acid (CAS 873660-49-2)] is manufactured by the 
reaction of elemental selenium with methyllithium to form a methylseleno

[[Page 578]]

salt, which is then reacted with R,S-2-hydroxybutyrolactone to form a 
salt of 2-hydroxy-4-methylselenobutanoic acid. After acidification and 
purification, the additive consists of not less than 39.5 percent total 
selenium by weight with a selenomethionine hydroxy analogue content of 
not less than 98 percent of total selenium. The total organic selenium 
content of the additive is not less than 99 percent of total selenium.
    (1) The selenomethionine hydroxy analogue meets the following 
specifications:
    (i) Arsenic, not more than 2 parts per million (ppm);
    (ii) Cadmium, not more than 1 ppm;
    (iii) Lead, not more than 1 ppm; and
    (iv) Mercury, not more than 1 ppm.
    (2) Selenium, as selenomethionine hydroxy analogue, is added to 
complete feed for chickens, turkeys, and swine at a level not to exceed 
0.3 ppm.
    (3) To ensure safe use of the additive, in addition to the other 
information required by the Federal Food, Drug, and Cosmetic Act, the 
label and labeling of selenomethionine hydroxy analogue in its packaged 
form shall contain:
    (i) The name, selenomethionine hydroxy analogue;
    (ii) Minimum and maximum guarantees for a total selenium content of 
not less than 2.08 percent (weight/weight) and not more than 2.24 
percent;
    (iii) Minimum guarantee for selenomethionine hydroxy analogue 
content of not less than 5.2 percent;
    (iv) The following statement, ``Storage Conditions: Selenomethionine 
hydroxy analogue must be stored in a closed package at temperatures not 
higher than 20 [deg]C (68 [deg]F).''; and
    (v) An expiration date not to exceed 1 year from the date of 
manufacture.
    (4) The additive, as selenomethionine hydroxy analogue, shall be 
incorporated into each ton of complete feed by adding no less than 1 
pound of a premix containing no more than 272.4 milligrams of added 
selenium per pound.
    (5) Usage of this additive must conform to the requirements of 
paragraphs (d) and (e) of this section.

[52 FR 10888, Apr. 6, 1987; 52 FR 21001, June 4, 1987, as amended at 54 
FR 14215, Apr. 10, 1989; 54 FR 15874, Apr. 19, 1989; 60 FR 53703, Oct. 
17, 1995; 65 FR 35824, June 6, 2000; 65 FR 53167, Sept. 1, 2000; 67 FR 
46851, July 17, 2002; 68 FR 52340, Sept. 3, 2003; 72 FR 39561, July 19, 
2007; 84 FR 7993, Mar. 6, 2019]

    Effective Date Note: At 58 FR 47973, Sept. 13, 1993, the amendments 
to Sec. 573.920 that were published at 52 FR 10887, Apr. 6, 1987; 52 FR 
21001, June 4, 1987; and 54 FR 14214, Apr. 10, 1989 were stayed until 
further notice. At 59 FR 45973, Sept. 6, 1994, the stay was confirmed.



Sec. 573.940  Silicon dioxide.

    The food additive silicon dioxide may be safely used in animal feed 
in accordance with the following conditions:
    (a) The food additive is manufactured by vapor phase hydrolysis or 
by other means whereby the particle size is such as to accomplish the 
intended effect.
    (b) It is used or intended for use as an anticaking agent, 
antifoaming agent, carrier, and/or grinding aid in animal feed, 
including ingredients, intermediate premixes, premixes, supplements, 
concentrates, and complete feed.
    (c) To ensure safe use of the additive, silicon dioxide is to be 
used in an amount not to exceed that reasonably required to accomplish 
its intended effect, and silicon dioxide from all sources cannot exceed 
2 percent by weight of the complete feed.
    (d) To ensure safe use of the additive, the label and labeling of 
the additive and ingredients, intermediate premixes, premixes, 
supplements, concentrates, and complete feed containing the additive 
shall meet the requirements of the Federal Food, Drug, and Cosmetic Act, 
including part 501 of this chapter.
    (e) To ensure safe use of the additive, in addition to the other 
information required by the Federal Food, Drug, and Cosmetic Act, the 
label and labeling of the additive and ingredients, intermediate 
premixes, premixes, supplements, and concentrates containing the 
additive shall have:
    (1) A statement of the concentration of the additive.

[[Page 579]]

    (2) A statement that silicon dioxide from all sources cannot exceed 
2 percent by weight of the complete feed.

[41 FR 38652, Sept. 10, 1976, as amended at 83 FR 8930, Mar. 2, 2018; 84 
FR 7993, Mar. 6, 2019; 85 FR 33539, June 2, 2020]



Sec. 573.960  Sorbitan monostearate.

    The food additive sorbitan monostearate may be safely used alone or 
in combination with polysorbate 60 as an emulsifier in mineral premixes 
and dietary supplements for animal feeds.



Sec. 573.980  Taurine.

    The food additive taurine (2-amino-ethanesulfonic acid) may be 
safely used in feed in accordance with the following prescribed 
conditions:
    (a) It is used as a nutritional supplement in the feed of growing 
chickens.
    (b) It is added to complete feeds so that the total taurine content 
does not exceed 0.054 percent of the feed.
    (c) To assure safe use of the additive, the label and labeling shall 
bear in addition to the other information required by the Act:
    (1) The name of the additive.
    (2) The quantity of the additive contained therein.
    (3) Adequate directions for use.



Sec. 573.1000  Verxite.

    The food additive verxite may be safely used in animal feed in 
accordance with the following prescribed conditions:
    (a) The additive is a magnesium-aluminum-iron silicate conforming to 
one of the following:
    (1)(i) Verxite granules: The additive contains a minimum of 98 
percent of hydrobiotite; it is thermally expanded and has a bulk density 
of from 5 to 9 pounds per cubic foot.
    (ii) It is used or intended for use:
    (a) In poultry feed at a level not to exceed 5 percent of the weight 
of the finished feed as a nonnutritive bulking agent for restricting 
calorie intake in pullet replacement feeds.
    (b) As an anticaking or blending agent, pelleting aid, or 
nonnutritive carrier for the incorporation of nutrients in poultry, 
swine, dog, or ruminant feeds, in an amount not to exceed that necessary 
to accomplish its intended effect and in no case to exceed 1.5 percent 
of the dog feed or 5 percent of the final feed for other animals.
    (2)(i) Verxite flakes: The additive contains a minimum of 98 percent 
of hydrobiotite; it has a bulk density of from 20 to 30 pounds per cubic 
foot.
    (ii) It is used or intended for use as an anticaking or blending 
agent in ruminant feeds in an amount not to exceed that necessary to 
accomplish its intended effect and in no case to exceed 1 percent by 
weight of the final feed for ruminants.
    (3)(i) Verxite grits: The additive contains a minimum of 80 percent 
of hydrobiotite; it has a bulk density of from 40 to 50 pounds per cubic 
foot.
    (ii) It is used or intended for use as a partial roughage 
replacement in ruminant feeds in an amount not to exceed that necessary 
to accomplish its intended effect and in no case to exceed 1 percent by 
weight of the final feed.
    (b) To assure safe use of the additive, the label of any feed 
additive supplement, feed additive concentrate, feed additive premix, or 
complete feed prepared therefrom shall bear, in addition to the other 
information required by the Act, the name of the additive (verxite 
granules, verxite flakes, or verxite grits), adequate directions for 
use, and, when the additive is present in excess of 1 percent, a 
statement of the quantity of the additive contained therein and the term 
``nonnutritive'' in juxtaposition therewith.



Sec. 573.1010  Xanthan gum.

    The food additive xanthan gum may be safely used in animal feed as 
follows:
    (a) The food additive is xanthan gum as defined in Sec. 172.695 of 
this chapter and meets all of the specifications thereof.
    (b) It is used or intended for use as a stabilizer, emulsifier, 
thickener, suspending agent, or bodying agent in animal feed as follows:
    (1) In calf milk replacers at a maximum use level of 0.1 percent, as 
fed.
    (2) In liquid feed supplements for ruminant animals at a maximum use 
level of 0.25 percent (5 pounds per ton).
    (c) To assure safe use of the additive:
    (1) The label of its container shall bear, in addition to other 
information

[[Page 580]]

required by the act, the name of the additive.
    (2) The label or labeling of the additive container shall bear 
adequate directions for use.

[49 FR 44630, Nov. 8, 1984]



Sec. 573.1020  Yellow prussiate of soda.

    Yellow prussiate of soda (sodium ferrocyanide decahydrate: 
Na4Fe(Cn)6[deg]-10H2O) may be safely 
used as an anticaking agent in salt for animal consumption at a level 
not to exceed 13 parts per million. The additive contains a minimum of 
99.0 percent by weight of sodium ferrocyanide decahydrate.

[41 FR 38657, Sept. 10, 1976; 41 FR 48100, Nov. 2, 1976]



PART 579_IRRADIATION IN THE PRODUCTION, PROCESSING, AND HANDLING
OF ANIMAL FEED AND PET FOOD--Table of Contents



                      Subpart A_General Provisions

Sec.
579.12 Incorporation of regulations in part 179.

                Subpart B_Radiation and Radiation Sources

579.22 Ionizing radiation for treatment of animal diets.
579.40 Ionizing radiation for the treatment of poultry feed and poultry 
          feed ingredients.

    Authority: 21 U.S.C. 321, 342, 343, 348, 371.



                      Subpart A_General Provisions



Sec. 579.12  Incorporation of regulations in part 179.

    Regulations providing for irradiation in the production, processing, 
and handling of food in part 179 of this chapter are incorporated in 
subchapter E as applicable to use in the production, processing, 
handling, and labeling of animal feed and pet food, except where 
specifically provided for in this part. Any facility that treats animal 
feed and pet food with ionizing radiation must comply with the 
requirements of part 507 of this chapter and other applicable 
regulations.

[51 FR 5993, Feb. 19, 1986, as amended at 80 FR 56356, Sept. 17, 2015]



                Subpart B_Radiation and Radiation Sources



Sec. 579.22  Ionizing radiation for treatment of animal diets.

    Ionizing radiation for treatment of complete diets for animals may 
be safely used under the following conditions:
    (a) Energy sources. Ionizing radiation is limited to:
    (1) Gamma rays for sealed units of the radionuclides cobalt-60 or 
cesium-137.
    (2) Electrons generated from machine sources at energy levels not to 
exceed 10 million electron volts.
    (b) Uses. (1) The ionizing radiation is used or intended for use in 
single treatment as follows:

------------------------------------------------------------------------
      Food for irradiation            Limitations             Use
------------------------------------------------------------------------
Bagged complete diets, packaged   Absorbed dose: Not  Microbial
 feeds, feed ingredients, bulk     to exceed 50        disinfection,
 feeds, animal treats and chews.   kiloGrays. Feeds    control or
                                   and feed            elimination
                                   ingredients
                                   treated by
                                   irradiation
                                   should be
                                   formulated to
                                   account for
                                   nutritional loss.
------------------------------------------------------------------------

    (2) If an irradiated feed ingredient is less than 5 percent of the 
final product, the final product can be irradiated without being 
considered to be re-irradiated.

[51 FR 5993, Feb. 19, 1986; 51 FR 8315, Mar. 11, 1986, as amended at 58 
FR 18148, Apr. 8, 1993; 66 FR 18540, Apr. 10, 2001]



Sec. 579.40  Ionizing radiation for the treatment of poultry feed
and poultry feed ingredients.

    Ionizing radiation for the treatment of complete poultry diets and 
poultry feed ingredients may be safely used as follows:
    (a) Energy sources. Ionizing radiation is limited to:
    (1) Gamma rays from sealed units of cobalt-60 or cesium-137;

[[Page 581]]

    (2) Electrons generated from machine sources at energy levels not to 
exceed 10 million electron volts (MeV);
    (3) X-rays generated from machine sources at energies not to exceed 
5 MeV, except as permitted by Sec. 179.26(a)(4) of this chapter; or
    (4) X-rays generated from machine sources using tantalum or gold as 
the target material and using energies not to exceed 7.5 MeV.
    (b) Limitation. The ionizing radiation is used for feed or feed 
ingredients that do not contain drugs.
    (c) Use. Ionizing radiation is used as a single treatment for 
rendering complete poultry diets or poultry feed ingredients salmonella 
negative as follows:
    (1) Minimum dose 2.0 kiloGrays (kGy) (0.2 megarad (Mrad)); maximum 
dose 25 kGy (2.5 megarads Mrad). The absorbed dose of irradiation is to 
be based on initial concentration of salmonella using the relationship 
that 1.0 kGy (0.1 Mrad) reduces salmonella concentration by one log 
cycle (one decimal reduction).
    (2) Feeds treated by irradiation should be formulated to account for 
nutritional loss.
    (3) If an irradiated feed ingredient is less than 5 percent of the 
final product, the final product can be irradiated without being 
considered to be reirradiated.

[60 FR 50099, Sept. 28, 1995, as amended at 78 FR 27304, May 10, 2013; 
78 FR 34565, June 10, 2013]



PART 582_SUBSTANCES GENERALLY RECOGNIZED AS SAFE--Table of Contents



                      Subpart A_General Provisions

Sec.
582.1 Substances that are generally recognized as safe.
582.10 Spices and other natural seasonings and flavorings.
582.20 Essential oils, oleoresins (solvent-free), and natural 
          extractives (including distillates).
582.30 Natural substances used in conjunction with spices and other 
          natural seasonings and flavorings.
582.40 Natural extractives (solvent-free) used in conjunction with 
          spices, seasonings, and flavorings.
582.50 Certain other spices, seasonings, essential oils, oleoresins, and 
          natural extracts.
582.60 Synthetic flavoring substances and adjuvants.
582.80 Trace minerals added to animal feeds.
582.99 Adjuvants for pesticide chemicals.

                Subpart B_General Purpose Food Additives

582.1005 Acetic acid.
582.1009 Adipic acid.
582.1033 Citric acid.
582.1057 Hydrochloric acid.
582.1061 Lactic acid.
582.1069 Malic acid.
582.1073 Phosphoric acid.
582.1077 Potassium acid tartrate.
582.1087 Sodium acid pyrophosphate.
582.1091 Succinic acid.
582.1095 Sulfuric acid.
582.1099 Tartaric acid.
582.1125 Aluminum sulfate.
582.1127 Aluminum ammonium sulfate.
582.1129 Aluminum potassium sulfate.
582.1131 Aluminum sodium sulfate.
582.1135 Ammonium bicarbonate.
582.1137 Ammonium carbonate.
582.1139 Ammonium hydroxide.
582.1141 Ammonium phosphate.
582.1143 Ammonium sulfate.
582.1155 Bentonite.
582.1165 Butane.
582.1191 Calcium carbonate.
582.1193 Calcium chloride.
582.1195 Calcium citrate.
582.1199 Calcium gluconate.
582.1205 Calcium hydroxide.
582.1207 Calcium lactate.
582.1210 Calcium oxide.
582.1217 Calcium phosphate.
582.1235 Caramel.
582.1240 Carbon dioxide.
582.1275 Dextrans.
582.1320 Glycerin.
582.1324 Glyceryl monostearate.
582.1355 Helium.
582.1366 Hydrogen peroxide.
582.1400 Lecithin.
582.1425 Magnesium carbonate.
582.1428 Magnesium hydroxide.
582.1431 Magnesium oxide.
582.1480 Methylcellulose.
582.1500 Monoammonium glutamate.
582.1516 Monopotassium glutamate.
582.1540 Nitrogen.
582.1585 Papain.
582.1613 Potassium bicarbonate.
582.1619 Potassium carbonate.
582.1625 Potassium citrate.
582.1631 Potassium hydroxide.
582.1643 Potassium sulfate.
582.1655 Propane.
582.1666 Propylene glycol.
582.1685 Rennet.
582.1711 Silica aerogel.
582.1721 Sodium acetate.
582.1736 Sodium bicarbonate.
582.1742 Sodium carbonate.

[[Page 582]]

582.1745 Sodium carboxymethylcellulose.
582.1748 Sodium caseinate.
582.1751 Sodium citrate.
582.1763 Sodium hydroxide.
582.1775 Sodium pectinate.
582.1778 Sodium phosphate.
582.1781 Sodium aluminum phosphate.
582.1792 Sodium sesquicarbonate.
582.1804 Sodium potassium tartrate.
582.1810 Sodium tripolyphosphate.
582.1901 Triacetin.
582.1973 Beeswax.
582.1975 Bleached beeswax.
582.1978 Carnauba wax.

                       Subpart C_Anticaking Agents

582.2122 Aluminum calcium silicate.
582.2227 Calcium silicate.
582.2437 Magnesium silicate.
582.2727 Sodium aluminosilicate.
582.2729 Hydrated sodium calcium aluminosilicate.
582.2906 Tricalcium silicate.

                    Subpart D_Chemical Preservatives

582.3013 Ascorbic acid.
582.3021 Benzoic acid.
582.3041 Erythorbic acid.
582.3081 Propionic acid.
582.3089 Sorbic acid.
582.3109 Thiodipropionic acid.
582.3149 Ascorbyl palmitate.
582.3169 Butylated hydroxyanisole.
582.3173 Butylated hydroxytoluene.
582.3189 Calcium ascorbate.
582.3221 Calcium propionate.
582.3225 Calcium sorbate.
582.3280 Dilauryl thiodipropionate.
582.3336 Gum guaiac.
582.3490 Methylparaben.
582.3616 Potassium bisulfite.
582.3637 Potassium metabisulfite.
582.3640 Potassium sorbate.
582.3660 Propyl gallate.
582.3670 Propylparaben.
582.3731 Sodium ascorbate.
582.3733 Sodium benzoate.
582.3739 Sodium bisulfite.
582.3766 Sodium metabisulfite.
582.3784 Sodium propionate.
582.3795 Sodium sorbate.
582.3798 Sodium sulfite.
582.3845 Stannous chloride.
582.3862 Sulfur dioxide.
582.3890 Tocopherols.

                      Subpart E_Emulsifying Agents

582.4101 Diacetyl tartaric acid esters of mono- and diglycerides of 
          edible fats or oils, or edible fat-forming fatty acids.
582.4505 Mono- and diglycerides of edible fats or oils, or edible fat-
          forming acids.
582.4521 Monosodium phosphate derivatives of mono- and diglycerides of 
          edible fats or oils, or edible fat-forming fatty acids.
582.4666 Propylene glycol.

             Subpart F_Nutrients and/or Dietary Supplements

582.5013 Ascorbic acid.
582.5017 Aspartic acid.
582.5049 Aminoacetic acid.
582.5065 Linoleic acid.
582.5118 Alanine.
582.5145 Arginine.
582.5159 Biotin.
582.5191 Calcium carbonate.
582.5195 Calcium citrate.
582.5201 Calcium glycerophosphate.
582.5210 Calcium oxide.
582.5212 Calcium pantothenate.
582.5217 Calcium phosphate.
582.5223 Calcium pyrophosphate.
582.5230 Calcium sulfate.
582.5245 Carotene.
582.5250 Choline bitartrate.
582.5252 Choline chloride.
582.5260 Copper gluconate.
582.5271 Cysteine.
582.5273 Cystine.
582.5301 Ferric phosphate.
582.5304 Ferric pyrophosphate.
582.5306 Ferric sodium pyrophosphate.
582.5308 Ferrous gluconate.
582.5311 Ferrous lactate.
582.5315 Ferrous sulfate.
582.5361 Histidine.
582.5370 Inositol.
582.5375 Iron reduced.
582.5381 Isoleucine.
582.5406 Leucine.
582.5411 Lysine.
582.5431 Magnesium oxide.
582.5434 Magnesium phosphate.
582.5443 Magnesium sulfate.
582.5446 Manganese chloride.
582.5449 Manganese citrate.
582.5452 Manganese gluconate.
582.5455 Manganese glycerophosphate.
582.5458 Manganese hypophosphite.
582.5461 Manganese sulfate.
582.5464 Manganous oxide.
582.5470 Mannitol.
582.5475 Methionine.
582.5477 Methionine hydroxy analog and its calcium salts.
582.5530 Niacin.
582.5535 Niacinamide.
582.5580 D-Pantothenyl alcohol.
582.5590 Phenylalanine.
582.5622 Potassium chloride.
582.5628 Potassium glycerophosphate.
582.5634 Potassium iodide.
582.5650 Proline.
582.5676 Pyridoxine hydrochloride.
582.5695 Riboflavin.
582.5697 Riboflavin-5-phosphate.
582.5701 Serine.
582.5772 Sodium pantothenate.
582.5778 Sodium phosphate.
582.5835 Sorbitol.

[[Page 583]]

582.5875 Thiamine hydrochloride.
582.5878 Thiamine mononitrate.
582.5881 Threonine.
582.5890 Tocopherols.
582.5892 a-Tocopherol acetate.
582.5915 Tryptophane.
582.5920 Tyrosine.
582.5925 Valine.
582.5930 Vitamin A.
582.5933 Vitamin A acetate.
582.5936 Vitamin A palmitate.
582.5945 Vitamin B12.
582.5950 Vitamin D2.
582.5953 Vitamin D3.
582.5985 Zinc chloride.
582.5988 Zinc gluconate.
582.5991 Zinc oxide.
582.5994 Zinc stearate.
582.5997 Zinc sulfate.

                         Subpart G_Sequestrants

582.6033 Citric acid.
582.6085 Sodium acid phosphate.
582.6099 Tartaric acid.
582.6185 Calcium acetate.
582.6193 Calcium chloride.
582.6195 Calcium citrate.
582.6197 Calcium diacetate.
582.6199 Calcium gluconate.
582.6203 Calcium hexametaphosphate.
582.6215 Monobasic calcium phosphate.
582.6219 Calcium phytate.
582.6285 Dipotassium phosphate.
582.6290 Disodium phosphate.
582.6386 Isopropyl citrate.
582.6511 Monoisopropyl citrate.
582.6625 Potassium citrate.
582.6751 Sodium citrate.
582.6754 Sodium diacetate.
582.6757 Sodium gluconate.
582.6760 Sodium hexametaphosphate.
582.6769 Sodium metaphosphate.
582.6778 Sodium phosphate.
582.6787 Sodium pyrophosphate.
582.6789 Tetra sodium pyrophosphate.
582.6801 Sodium tartrate.
582.6804 Sodium potassium tartrate.
582.6807 Sodium thiosulfate.
582.6810 Sodium tripolyphosphate.
582.6851 Stearyl citrate.

                          Subpart H_Stabilizers

582.7115 Agar-agar.
582.7133 Ammonium alginate.
582.7187 Calcium alginate.
582.7255 Chondrus extract.
582.7330 Gum arabic.
582.7333 Gum ghatti.
582.7339 Guar gum.
582.7343 Locust bean gum.
582.7349 Sterculia gum.
582.7351 Gum tragacanth.
582.7610 Potassium alginate.
582.7724 Sodium alginate.

    Authority: 21 U.S.C. 321, 342, 348, 371.

    Source: 41 FR 38657, Sept. 10, 1976, unless otherwise noted.



                      Subpart A_General Provisions



Sec. 582.1  Substances that are generally recognized as safe.

    (a) It is impracticable to list all substances that are generally 
recognized as safe for their intended use. However, by way of 
illustration, the Commissioner regards such common food ingredients as 
salt, pepper, sugar, vinegar, baking powder, and monosodium glutamate as 
safe for their intended use. The lists in subparts B through H of this 
part include additional substances that, when used for the purposes 
indicated, in accordance with good manufacturing or feeding practice, 
are regarded by the Commissioner as generally recognized as safe for 
such uses.
    (b) For the purposes of this section, good manufacturing or feeding 
practice shall be defined to include the following restrictions:
    (1) The quantity of a substance added to animal food does not exceed 
the amount reasonably required to accomplish its intended physical, 
nutritional, or other technical effect in food; and
    (2) The quantity of a substance that becomes a component of animal 
food as a result of its use in the manufacturing, processing, or 
packaging of food, and which is not intended to accomplish any physical 
or other technical effect in the food itself, shall be reduced to the 
extent reasonably possible.
    (3) The substance is of appropriate grade and is prepared and 
handled as a food ingredient. Upon request the Commissioner will offer 
an opinion, based on specifications and intended use, as to whether or 
not a particular grade or lot of the substance is of suitable purity for 
use in food and would generally be regarded as safe for the purpose 
intended, by experts qualified to evaluate its safety.
    (c) The inclusion of substances in the list of nutrients does not 
constitute a finding on the part of the Department that the substance is 
useful as a supplement to the diet for animals.
    (d) Substances that are generally recognized as safe for their 
intended use

[[Page 584]]

within the meaning of section 409 of the Act are listed in subparts B 
through H of this part. When the status of a substance has been 
reevaluated and affirmed as GRAS or deleted from subparts B through H of 
this part, an appropriate explanation will be noted, e.g., ``affirmed as 
GRAS,'' ``food additive regulation,'' ``interim food additive 
regulation,'' or ``prohibited from use in food,'' with a reference to 
the appropriate new regulation. Such notation will apply only to the 
specific use covered by the review, e.g., direct animal food use and/or 
indirect animal food use and/or animal feed use and will not affect its 
status for other uses not specified in the referenced regulation, 
pending a specific review of such other uses.



Sec. 582.10  Spices and other natural seasonings and flavorings.

    Spices and other natural seasonings and flavorings that are 
generally recognized as safe for their intended use, within the meaning 
of section 409 of the act, are as follows:

------------------------------------------------------------------------
              Common name                 Botanical name of plant source
------------------------------------------------------------------------
Alfalfa herb and seed..................  Medicago sativa L.
Allspice...............................  Pimenta officinalis Lindl.
Ambrette seed..........................  Hibiscus abelmoschus L.
Angelica...............................  Angelica archangelica L. or
                                          other spp. of Angelica.
Angelica root..........................   Do.
Angelica seed..........................   Do.
Angostura (cusparia bark)..............  Galipea officinalis Hancock.
Anise..................................  Pimpinella anisum L.
Anise, star............................  Illicium verum Hook. f.
Balm (lemon balm)......................  Melissa officinalis L.
Basil, bush............................  Ocimum minimum L.
Basil, sweet...........................  Ocimum basilicum L.
Bay....................................  Laurus nobilis L.
Calendula..............................  Calendula officinalis L.
Camomile (chamomile), English or Roman.  Anthemis nobilis L.
Camomile (chamomile), German or          Matricaria chamomilla L.
 Hungarian.
Capers.................................  Capparis spinosa L.
Capsicum...............................  Capsicum frutescens L. or
                                          Capsicum annuum L.
Caraway................................  Carum carvi L.
Caraway, black (black cumin)...........  Nigella sativa L.
Cardamom (cardamon)....................  Elettaria cardamomum Maton.
Cassia, Chinese........................  Cinnamomum cassia Blume.
Cassia, Padang or Batavia..............  Cinnamomum burmanni Blume.
Cassia, Saigon.........................  Cinnamomum loureirii Nees.
Cayenne pepper.........................  Capsicum frutescens L. or
                                          Capsicum annuum L.
Celery seed............................  Apium graveolens L.
Chervil................................  Anthriscus cerefolium (L.)
                                          Hoffm.
Chives.................................  Allium schoenoprasum L.
Cinnamon, Ceylon.......................  Cinnamomum zeylanicum Nees.
Cinnamon, Chinese......................  Cinnamomum cassia Blume.
Cinnamon, Saigon.......................  Cinnamomum loureirii Nees.
Clary (clary sage).....................  Salvia sclarea L.
Clover.................................  Trifolium spp.
Cloves.................................  Eugenia caryophyllata Thunb.
Coriander..............................  Coriandrum sativum L.
Cumin (cummin).........................  Cuminum cyminum L.
Cumin, black (black caraway)...........  Nigella sativa L.
Dill...................................  Anethum graveolens L.
Elder flowers..........................  Sambucus canadensis L.
Fennel, common.........................  Foeniculum vulgare Mill.
Fennel, sweet (finocchio, Florence       Foeniculum vulgare Mill. var.
 fennel).                                 duice (DC.) Alex.
Fenugreek..............................  Trigonella foenum-graecum L.
Galanga (galangal).....................  Alpina officinarum Hance.
Garlic.................................  Allium sativum L.
Geranium...............................  Pelargonium spp.
Ginger.................................  Zingiber officinale Rosc.
Glycyrrhiza............................  Glycyrrhiza glabra L. and other
                                          spp. of Glycyrrhiza.
Grains of paradise.....................  Amomum melegueta Rosc.
Horehound (hoarhound)..................  Marrubium vulgare L.
Horseradish............................  Armoracia lapathifolia Gilib.
Hyssop.................................  Hyssopus officinalis L.
Lavender...............................  Lavandula officinalis Chaix.
Licorice...............................  Glycyrrhiza glabra L. and other
                                          spp. of Glycyrrhiza.
Linden flowers.........................  Tilia spp.
Mace...................................  Myristica fragrans Houtt.

[[Page 585]]

 
Marigold, pot..........................  Calendula officinalis L.
Marjoram, pot..........................  Majorana onites (L.) Benth.
Marjoram, sweet........................  Majorana hortensis Moench.
Mustard, black or brown................  Brassica nigra (L.) Koch.
Mustard, brown.........................  Brassica juncea (L.) Coss.
Mustard, white or yellow...............  Brassica hirta Moench.
Nutmeg.................................  Myristica fragrans Houtt.
Oregano (oreganum, Mexican oregano,      Lippia spp.
 Mexican sage, origan).
Paprika................................  Capsicum annuum L.
Parsley................................  Petroselinum crispum (Mill.)
                                          Mansf.
Pepper, black..........................  Piper nigrum L.
Pepper, cayenne........................  Capsicum frutescens L. or
                                          Capsicum annuum L.
Pepper, red............................   Do.
Pepper, white..........................  Piper nigrum L.
Peppermint.............................  Mentha piperita L.
Poppy seed.............................  Papaver somniferum L.
Pot marigold...........................  Calendula officinalis L.
Pot marjoram...........................  Majorana onites (L.) Benth.
Rosemary...............................  Rosmarinus officinalis L.
Rue....................................  Ruta graveolens L.
Saffron................................  Crocus sativus L.
Sage...................................  Salvia officinalis L.
Sage, Greek............................  Salvia triloba L.
Savory, summer.........................  Satureia hortensis L.
                                          (Satureja).
Savory, winter.........................  Satureia montana L. (Satureja).
Sesame.................................  Sesamum indicum L.
Spearmint..............................  Mentha spicata L.
Star anise.............................  Illicium verum Hook. f.
Tarragon...............................  Artemisia dracunculus L.
Thyme..................................  Thymus vulgaris L.
Thyme, wild or creeping................  Thymus serpyllum L.
Turmeric...............................  Curcuma longa L.
Vanilla................................  Vanilla planifolia Andr. or
                                          Vanilla tahitensis J. W.
                                          Moore.
Zedoary................................  Curcuma zedoaria Rosc.
------------------------------------------------------------------------



Sec. 582.20  Essential oils, oleoresins (solvent-free), and natural
extractives (including distillates).

    Essential oils, oleoresins (solvent-free), and natural extractives 
(including distillates) that are generally recognized as safe for their 
intended use, within the meaning of section 409 of the act, are as 
follows:

------------------------------------------------------------------------
              Common name                 Botanical name of plant source
------------------------------------------------------------------------
Alfalfa................................  Medicago sativa L.
Allspice...............................  Pimenta officinalis Lindl.
Almond, bitter (free from prussic acid)  Prunus amygdalus Batsch, Prunus
                                          armeniaca L. or Prunus persica
                                          (L.) Batsch.
Ambrette (seed)........................  Hibiscus moschatus Moench.
Angelica root..........................  Angelica archangelica L.
Angelica seed..........................   Do.
Angelica stem..........................   Do.
Angostura (cusparia bark)..............  Galipea officinalis Hancock.
Anise..................................  Pimpinella anisum L.
Asafetida..............................  Ferula assa-foetida L. and
                                          related spp. of Ferula.
Balm (lemon balm)......................  Melissa officinalis L.
Balsam of Peru.........................  Myroxylon pereirae Klotzsch.
Basil..................................  Ocimum basilicum L.
Bay leaves.............................  Laurus nobilis L.
Bay (myrcia oil).......................  Pimenta racemosa (Mill.) J. W.
                                          Moore.
Bergamot (bergamot orange).............  Citrus aurantium L. subsp.
                                          bergamia Wright et Arn.
Bitter almond (free from prussic acid).  Prunus amygdalus Batsch, Prunus
                                          armeniaca L., or Prunus
                                          persica (L.) Batsch.
Bois de rose...........................  Aniba rosaeodora Ducke.
Cacao..................................  Theobroma cacao L.
Camomile (chamomile) flowers, Hungarian  Matricaria chamomilla L.
Camomile (chamomile) flowers, Roman or   Anthemis nobilis L.
 English.
Cananga................................  Cananga odorata Hook. f. and
                                          Thoms.
Capsicum...............................  Capsicum frutescens L. and
                                          Capsicum annuum L.
Caraway................................  Carum carvi L.
Cardamom seed (cardamon)...............  Elettaria cardamomum Maton.

[[Page 586]]

 
Carob bean.............................  Ceratonia siliqua L.
Carrot.................................  Daucus carota L.
Cascarilla bark........................  Croton eluteria Benn.
Cassia bark, Chinese...................  Cinnamomum cassia Blume.
Cassia bark, Padang or Batavia.........  Cinnamomum burmanni Blume.
Cassia bark, Saigon....................  Cinnamomum loureirii Nees.
Celery seed............................  Apium graveolens L.
Cherry, wild, bark.....................  Prunus serotina Ehrh.
Chervil................................  Anthriscus cerefolium (L.)
                                          Hoffm.
Chicory................................  Cichorium intybus L.
Cinnamon bark, Ceylon..................  Cinnamomum zeylanicum Nees.
Cinnamon bark, Chinese.................  Cinnamomum cassia Blume.
Cinnamon bark, Saigon..................  Cinnamomum loureirii Nees.
Cinnamon leaf, Ceylon..................  Cinnamomum zeylanicum Nees.
Cinnamon leaf, Chinese.................  Cinnamomum cassia Blume.
Cinnamon leaf, Saigon..................  Cinnamomum loureirii Nees.
Citronella.............................  Cymbopogon nardus Rendle.
Citrus peels...........................  Citrus spp.
Clary (clary sage).....................  Salvia sclarea L.
Clove bud..............................  Eugenia caryophyllata Thunb.
Clove leaf.............................   Do.
Clove stem.............................   Do.
Clover.................................  Trifolium spp.
Coca (decocainized)....................  Erythroxylum coca Lam. and
                                          other spp. of Erythroxylum.
Coffee.................................  Coffea spp.
Cola nut...............................  Cola acuminata Schott and
                                          Endl., and other spp. of Cola.
Coriander..............................  Coriandrum sativum L.
Corn silk..............................  Zea mays L.
Cumin (cummin).........................  Cuminum cyminum L.
Curacao orange peel (orange, bitter      Citrus aurantium L.
 peel).
Cusparia bark..........................  Galipea officinalis Hancock.
Dandelion..............................  Taraxacum officinale Weber and
                                          T. laevigatum DC.
Dandelion root.........................   Do.
Dill...................................  Anethum graveolens L.
Dog grass (quackgrass, triticum).......  Agropyron repens (L.) Beauv.
Elder flowers..........................  Sambucus canadensis L. and S.
                                          nigra L.
Estragole (esdragol, esdragon,           Artemisia dracunculus L.
 tarragon).
Estragon (tarragon)....................   Do.
Fennel, sweet..........................  Foeniculum vulgare Mill.
Fenugreek..............................  Trigonella foenum-graecum L.
Galanga (galangal).....................  Alpinia officinarum Hance.
Garlic.................................  Allium sativum L.
Geranium...............................  Pelargonium spp.
Geranium, East Indian..................  Cymbopogon martini Stapf.
Geranium, rose.........................  Pelargonium graveolens L'Her.
Ginger.................................  Zingiber officinale Rosc.
Glycyrrhiza............................  Glycyrrhiza glabra L. and other
                                          spp. of Glycyrrhiza.
Glycyrrhizin, ammoniated...............   Do.
Grapefruit.............................  Citrus paradisi Macf.
Guava..................................  Psidium spp.
Hickory bark...........................  Carya spp.
Horehound (hoarhound)..................  Marrubium vulgare L.
Hops...................................  Humulus lupulus L.
Horsemint..............................  Monarda punctata L.
Hyssop.................................  Hyssopus officinalis L.
Immortelle.............................  Helichrysum augustifolium DC.
Jasmine................................  Jaminum officinale L. and other
                                          spp. of Jasminum.
Juniper (berries)......................  Juniperus communis L.
Kola nut...............................  Cola acuminata Schott and
                                          Endl., and other spp. of Cola.
Laurel berries.........................  Laurus nobilis L.
Laurel leaves..........................  Laurus spp.
Lavender...............................  Lavandula officinalis Chaix.
Lavender, spike........................  Lavandula latifolia Vill.
Lavandin...............................  Hybrids between Lavandula
                                          officinalis Chaix and
                                          Lavandula latifolin Vill.
Lemon..................................  Citrus limon (L.) Burm. f.
Lemon balm (see balm).
Lemon grass............................  Cymbopogon citratus DC. and
                                          Cymbopogon flexuosus Stapf.
Lemon peel.............................  Citrus limon (L.) Burm. f.
Licorice...............................  Glycyrrhiza glabra L. and other
                                          spp. of Glycyrrhiza.
Lime...................................  Citrus aurantifolia Swingle.
Linden flowers.........................  Tilia spp.
Locust bean............................  Ceratonia siliqua L.
Lupulin................................  Humulus lupulus L.

[[Page 587]]

 
Mace...................................  Myristica fragrans Houtt.
Malt (extract).........................  Hordeum vulgare L., or other
                                          grains.
Mandarin...............................  Citrus reticulata Blanco.
Marjoram, sweet........................  Majorana hortensis Moench.
Mate 1.................................  Ilex paraguariensis St. Hil.
Melissa (see balm).
Menthol................................  Mentha spp.
Menthyl acetate........................   Do.
Molasses (extract).....................  Saccharum officinarum L.
Mustard................................  Brassica spp.
Naringin...............................  Citrus paradisi Macf.
Neroli, bigarade.......................  Citrus aurantium L.
Nutmeg.................................  Myristica fragrans Houtt.
Onion..................................  Allium cepa L.
Orange, bitter, flowers................  Citrus aurantium L.
Orange, bitter, peel...................   Do.
Orange leaf............................  Citrus sinensis (L.) Osbeck.
Orange, sweet..........................   Do.
Orange, sweet, flowers.................   Do.
Orange, sweet, peel....................   Do.
Origanum...............................  Origanum spp.
Palmarosa..............................  Cymbopogon martini Stapf.
Paprika................................  Capsicum annuum L.
Parsley................................  Petroselinum crispum (Mill.)
                                          Mansf.
Pepper, black..........................  Piper nigrum L.
Pepper, white..........................  Piper nigrum L.
Peppermint.............................  Mentha piperita L.
Peruvian balsam........................  Myroxylon pereirae Klotzsch.
Petitgrain.............................  Citrus aurantium L.
Petitgrain lemon.......................  Citrus limon (L.) Burm. f.
Petitgrain mandarin or tangerine.......  Citrus reticulata Blanco.
Pimenta................................  Pimenta officinalis Lindl.
Pimenta leaf...........................  Primenta officinalis Lindl.
Pipsissewa leaves......................  Chimaphila umbellata Nutt.
Pomegranate............................  Punica granatum L.
Prickly ash bark.......................  Xanthoxylum (or Zanthoxylum)
                                          Americanum Mill. or
                                          Xanthoxylum clava-herculis L.
Rose absolute..........................  Rosa alba L., Rosa centifolia
                                          L., Rosa damascena Mill., Rosa
                                          gallica L., and vars. of these
                                          spp.
Rose (otto of roses, attar of roses)...   Do.
Rose buds..............................   Do.
Rose flowers...........................   Do.
Rose fruit (hips)......................   Do.
Rose geranium..........................  Pelargonium graveolens L'Her.
Rose leaves............................  Rosa spp.
Rosemary...............................  Rosmarinus officinalis L.
Rue....................................  Ruta graveolens L.
Saffron................................  Crocus sativus L.
Sage...................................  Salvia officinalis L.
Sage, Greek............................  Salvia triloba L.
Sage, Spanish..........................  Salvia lavandulaefolia Vahl.
St. John's bread.......................  Ceratonia siliqua L.
Savory, summer.........................  Satureia hortensis L.
Savory, winter.........................  Satureia montana L.
Schinus molle..........................  Schinus molle L.
Sloe berries (blackthorn berries)......  Prunus spinosa L.
Spearmint..............................  Mentha spicata L.
Spike lavender.........................  Lavandula latifolia Vill.
Tamarind...............................  Tamarindus indica L.
Tangerine..............................  Citrus reticulata Blanco.
Tannic acid............................  Nutgalls of Quercus infectoria
                                          Oliver and related spp. of
                                          Quercus. Also in many other
                                          plants.
Tarragon...............................  Artemisia dracunculus L.
Tea....................................  Thea sinensis L.
Thyme..................................  Thymus vulgaris L. and Thymus
                                          zygis var. gracilis Boiss.
Thyme, white...........................   Do.
Thyme, wild or creeping................  Thymus serpyllum L.
Triticum (see dog grass).
Tuberose...............................  Polianthes tuberosa L.
Turmeric...............................  Curcuma longa L.
Vanilla................................  Vanilla planifolia Andr. or
                                          Vanilla tahitensis J. W.
                                          Moore.
Violet flowers.........................  Viola odorata L.
Violet leaves..........................   Do.
Violet leaves absolute.................   Do.

[[Page 588]]

 
Wild cherry bark.......................  Prunus serotina Ehrh.
Ylang-ylang............................  Cananga odorata Hook. f. and
                                          Thoms.
Zedoary bark...........................  Curcuma zedoaria Rosc.
------------------------------------------------------------------------



Sec. 582.30  Natural substances used in conjunction with spices and 
other natural seasonings and flavorings.

    Natural substances used in conjunction with spices and other natural 
seasonings and flavorings that are generally recognized as safe for 
their intended use, within the meaning of section 409 of the act, are as 
follows:

------------------------------------------------------------------------
              Common name                 Botanical name of plant source
------------------------------------------------------------------------
Algae, brown (kelp)....................  Laminaria spp. and Nereocystis
                                          spp.
Algae, red.............................  Porphyra spp. and Rhodymenia
                                          palmata (L.) Grev.
Dulse..................................  Rhodymenia palmata (L.)
------------------------------------------------------------------------



Sec. 582.40  Natural extractives (solvent-free) used in conjunction 
with spices, seasonings, and flavorings.

    Natural extractives (solvent-free) used in conjunction with spices, 
seasonings, and flavorings that are generally recognized as safe for 
their intended use, within the meaning of section 409 of the act, are as 
follows:

------------------------------------------------------------------------
              Common name                 Botanical name of plant source
------------------------------------------------------------------------
Algae, brown...........................  Laminaria spp. and Nereocystis
                                          spp.
Algae, red.............................  Porphyra spp. and Rhodymenia
                                          palmata (L.) Grev.
Apricot kernel (persic oil)............  Prunus armeniaca L.
Dulse..................................  Rhodymenia palmata (L.) Grev.
Kelp (see algae, brown).
Peach kernel (persic oil)..............  Prunus persica Sieb. et Zucc.
Peanut stearine........................  Arachis hypogaea L.
Persic oil (see apricot kernel and
 peach kernel).
Quince seed............................  Cydonia oblonga Miller.
------------------------------------------------------------------------



Sec. 582.50  Certain other spices, seasonings, essential oils, 
oleoresins, and natural extracts.

    Certain other spices, seasonings, essential oils, oleoresins, and 
natural extracts that are generally recognized as safe for their 
intended use, within the meaning of section 409 of the act, are as 
follows:

------------------------------------------------------------------------
              Common name                           Derivation
------------------------------------------------------------------------
Ambergris..............................  Physeter macrocephalus L.
Castoreum..............................  Castor fiber L. and C.
                                          canadensis Kuhl.
Civet (zibeth, zibet, zibetum).........  Civet cats, Viverra civetta
                                          Schreber and Viverra zibetha
                                          Schreber.
Cognac oil, white and green............  Ethyl oenanthate, so-called.
Musk (Tonquin musk)....................  Musk deer, Moschus moschiferus
                                          L.
------------------------------------------------------------------------



Sec. 582.60  Synthetic flavoring substances and adjuvants.

    Synthetic flavoring substances and adjuvants that are generally 
recognized as safe for their intended use, within the meaning of section 
409 of the act, are as follows:

Acetaldehyde (ethanal).
Acetoin (acetyl methylcarbinol).
Aconitic acid (equisetic acid, citridic acid, achilleic acid).
Anethole (parapropenyl anisole).
Benzaldehyde (benzoic aldehyde).
N-Butyric acid (butanoic acid).
d- or l-Carvone (carvol).
Cinnamaldehyde (cinnamic aldehyde).
Citral (2,6-dimethyloctadien-2,6-al-8, geranial, neral).

[[Page 589]]

Decanal (N-decylaldhehyde, capraldehyde, capric aldehyde, 
caprinaldehyde, aldehyde C-10).
Diacetyl (2,3-butandeione). Ethyl acetate. Ethyl butyrate.
3-Methyl-3-phenyl glycidic acid ethyl ester (ethyl-methyl-phenyl-
glycidate, so-called strawberry aldehyde, C-16 aldehyde).
Ethyl vanillin.
Eugenol.
Geraniol (3,7-dimethyl-2,6 and 3,6-octadien-1-ol).
Geranyl acetate (geraniol acetate).
Glycerol (glyceryl) tributyrate (tributyrin, butyrin).
Limonene (d-, l-, and dl-).
Linalool (linalol, 3,7-dimethyl-1,6-octadien-3-ol).
Linalyl acetate (bergamol).
l-Malic acid.
Methyl anthranilate (methyl-2-aminobenzoate).
Piperonal (3,4-methylenedioxy-benzaldehyde, heliotropin).
Vanillin.



Sec. 582.80  Trace minerals added to animal feeds.

    These substances added to animal feeds as nutritional dietary 
supplements are generally recognized as safe when added at levels 
consistent with good feeding practice. \1\
---------------------------------------------------------------------------

    \1\ All substances listed may be in anhydrous or hydrated form.

------------------------------------------------------------------------
                Element                         Source compounds
------------------------------------------------------------------------
Cobalt................................  Cobalt acetate.
                                        Cobalt carbonate.
                                        Cobalt chloride.
                                        Cobalt oxide.
                                        Cobalt sulfate.
Copper................................  Copper carbonate.
                                        Copper chloride.
                                        Copper gluconate.
                                        Copper hydroxide.
                                        Copper orthophosphate.
                                        Copper oxide.
                                        Copper pyrophosphate.
                                        Copper sulfate.
Iodine................................  Calcium iodate.
                                        Calcium iodobehenate.
                                        Cuprous iodide.
                                        3,5-Diiodosalicylic acid.
                                        Ethylenediamine dihydroiodide.
                                        Potassium iodate.
                                        Potassium iodide.
                                        Sodium iodate.
                                        Sodium iodide.
                                        Thymol iodide.
Iron..................................  Iron ammonium citrate.
                                        Iron carbonate.
                                        Iron chloride.
                                        Iron gluconate.
                                        Iron oxide.
                                        Iron phosphate.
                                        Iron pyrophosphate.
                                        Iron sulfate.
                                        Reduced iron.
Manganese.............................  Manganese acetate.
                                        Manganese carbonate.
                                        Manganese citrate (soluble).
                                        Manganese chloride.
                                        Manganese gluconate.
                                        Manganese orthophosphate.
                                        Manganese phosphate (dibasic).
                                        Manganese sulfate.
                                        Manganous oxide.
Zinc..................................  Zinc acetate.
                                        Zinc carbonate.
                                        Zinc chloride.
                                        Zinc oxide.
                                        Zinc sulfate.
------------------------------------------------------------------------



Sec. 582.99  Adjuvants for pesticide chemicals.

    Adjuvants, identified and used in accordance with 40 CFR 180.910 and 
180.920, which are added to pesticide use dilutions by a grower or 
applicator prior to application to the raw agricultural commodity, are 
exempt from the requirement of tolerances under section 409 of the act.

[85 FR 72908, Nov. 16, 2020]



                Subpart B_General Purpose Food Additives



Sec. 582.1005  Acetic acid.

    (a) Product. Acetic acid.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.1009  Adipic acid.

    (a) Product. Adipic acid.
    (b) [Reserved]
    (c) Limitations, restrictions, or explanation. This substance is 
generally recognized as safe when used as a buffer and neutralizing 
agent in accordance with good manufacturing or feeding practice.



Sec. 582.1033  Citric acid.

    (a) Product. Citric acid.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.1057  Hydrochloric acid.

    (a) Product. Hydrochloric acid.
    (b) [Reserved]

[[Page 590]]

    (c) Limitations, restrictions, or explanation. This substance is 
generally recognized as safe when used as a buffer and neutralizing 
agent in accordance with good manufacturing or feeding practice.



Sec. 582.1061  Lactic acid.

    (a) Product. Lactic acid.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.1069  Malic acid.

    (a) Product. Malic acid.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.1073  Phosphoric acid.

    (a) Product. Phosphoric acid.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.1077  Potassium acid tartrate.

    (a) Product. Potassium acid tartrate.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.1087  Sodium acid pyrophosphate.

    (a) Product. Sodium acid pyrophosphate.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.1091  Succinic acid.

    (a) Product. Succinic acid.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.1095  Sulfuric acid.

    (a) Product. Sulfuric acid.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.1099  Tartaric acid.

    (a) Product. Tartaric acid.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.1125  Aluminum sulfate.

    (a) Product. Aluminum sulfate.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.1127  Aluminum ammonium sulfate.

    (a) Product. Aluminum ammonium sulfate.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.1129  Aluminum potassium sulfate.

    (a) Product. Aluminum potassium sulfate.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.1131  Aluminum sodium sulfate.

    (a) Product. Aluminum sodium sulfate.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.1135  Ammonium bicarbonate.

    (a) Product. Ammonium bicarbonate.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.1137  Ammonium carbonate.

    (a) Product. Ammonium carbonate.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.1139  Ammonium hydroxide.

    (a) Product. Ammonium hydroxide.
    (b) Conditions of use. This substance is generally recognized as 
safe when

[[Page 591]]

used in accordance with good manufacturing or feeding practice.



Sec. 582.1141  Ammonium phosphate.

    (a) Product. Ammonium phosphate (mono- and dibasic).
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.1143  Ammonium sulfate.

    (a) Product. Ammonium sulfate.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.1155  Bentonite.

    (a) Product. Bentonite.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.1165  Butane.

    (a) Product. Butane.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.1191  Calcium carbonate.

    (a) Product. Calcium carbonate.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.1193  Calcium chloride.

    (a) Product. Calcium chloride.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.1195  Calcium citrate.

    (a) Product. Calcium citrate.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.1199  Calcium gluconate.

    (a) Product. Calcium gluconate.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.1205  Calcium hydroxide.

    (a) Product. Calcium hydroxide.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.1207  Calcium lactate.

    (a) Product. Calcium lactate.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.1210  Calcium oxide.

    (a) Product. Calcium oxide.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.1217  Calcium phosphate.

    (a) Product. Calcium phosphate (mono-, di-, and tribasic).
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.1235  Caramel.

    (a) Product. Caramel.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.1240  Carbon dioxide.

    (a) Product. Carbon dioxide.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.1275  Dextrans.

    (a) Product. Dextrans of average molecular weight below 100,000.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.1320  Glycerin.

    (a) Product. Glycerin.
    (b) Conditions of use. This substance is generally recognized as 
safe when

[[Page 592]]

used in accordance with good manufacturing or feeding practice.



Sec. 582.1324  Glyceryl monostearate.

    (a) Product. Glyceryl monostearate.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.1355  Helium.

    (a) Product. Helium.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.1366  Hydrogen peroxide.

    (a) Product. Hydrogen peroxide.
    (b) [Reserved]
    (c) Limitations, restrictions, or explanation. This substance is 
generally recognized as safe when used as a bleaching agent in 
accordance with good manufacturing or feeding practice.



Sec. 582.1400  Lecithin.

    (a) Product. Lecithin.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.1425  Magnesium carbonate.

    (a) Product. Magnesium carbonate.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.1428  Magnesium hydroxide.

    (a) Product. Magnesium hydroxide.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.1431  Magnesium oxide.

    (a) Product. Magnesium oxide.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.1480  Methylcellulose.

    (a) Product. U.S.P. methylcellulose, except that the methoxy content 
shall not be less than 27.5 percent and not more than 31.5 percent on a 
dry-weight basis.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.1500  Monoammonium glutamate.

    (a) Product. Monoammonium glutamate.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.1516  Monopotassium glutamate.

    (a) Product. Monopotassium glutamate.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.1540  Nitrogen.

    (a) Product. Nitrogen.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.1585  Papain.

    (a) Product. Papain.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.1613  Potassium bicarbonate.

    (a) Product. Potassium bicarbonate.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.1619  Potassium carbonate.

    (a) Product. Potassium carbonate.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.1625  Potassium citrate.

    (a) Product. Potassium citrate.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.

[[Page 593]]



Sec. 582.1631  Potassium hydroxide.

    (a) Product. Potassium hydroxide.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.1643  Potassium sulfate.

    (a) Product. Potassium sulfate.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.1655  Propane.

    (a) Product. Propane.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.1666  Propylene glycol.

    (a) Product. Propylene glycol.
    (b) Conditions of use. This substance is generally recognized as 
safe (except in cat food) when used in accordance with good 
manufacturing or feeding practice.

[41 FR 38657, Sept. 10, 1976, as amended at 61 FR 19544, May 2, 1996]



Sec. 582.1685  Rennet.

    (a) Product. Rennet (rennin).
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.1711  Silica aerogel.

    (a) Product. Silica aerogel as a finely powdered microcellular 
silica foam having a minimum silica content of 89.5 percent.
    (b) [Reserved]
    (c) Limitations, restrictions, or explanation. This substance is 
generally recognized as safe when used as a component of antifoaming 
agents in accordance with good manufacturing or feeding practice.



Sec. 582.1721  Sodium acetate.

    (a) Product. Sodium acetate.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.1736  Sodium bicarbonate.

    (a) Product. Sodium bicarbonate.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.1742  Sodium carbonate.

    (a) Product. Sodium carbonate.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.1745  Sodium carboxymethylcellulose.

    (a) Product. Sodium carboxymethyl- cellulose is the sodium salt of 
carboxymethylcellulose not less than 99.5 percent on a dry-weight basis, 
with maximum substitution of 0.95 carboxymethyl groups per 
anhydroglucose unit, and with a minimum viscosity of 25 centipoises for 
2 percent by weight aqueous solution at 25 [deg]C.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.1748  Sodium caseinate.

    (a) Product. Sodium caseinate.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.1751  Sodium citrate.

    (a) Product. Sodium citrate.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.1763  Sodium hydroxide.

    (a) Product. Sodium hydroxide.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.1775  Sodium pectinate.

    (a) Product. Sodium pectinate.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.

[[Page 594]]



Sec. 582.1778  Sodium phosphate.

    (a) Product. Sodium phosphate (mono-, di-, and tribasic).
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.1781  Sodium aluminum phosphate.

    (a) Product. Sodium aluminum phosphate.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.1792  Sodium sesquicarbonate.

    (a) Product. Sodium sesquicarbonate.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.1804  Sodium potassium tartrate.

    (a) Product. Sodium potassium tartrate.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.1810  Sodium tripolyphosphate.

    (a) Product. Sodium tripolyphosphate.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.1901  Triacetin.

    (a) Product. Triacetin (glyceryl triacetate).
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.1973  Beeswax.

    (a) Product. Beeswax (yellow wax).
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.1975  Bleached beeswax.

    (a) Product. Bleached beeswax (white wax).
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.1978  Carnauba wax.

    (a) Product. Carnauba wax.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



                       Subpart C_Anticaking Agents



Sec. 582.2122  Aluminum calcium silicate.

    (a) Product. Aluminum calcium silicate.
    (b) Tolerance. 2 percent.
    (c) Limitations, restrictions, or explanation. This substance is 
generally recognized as safe when used in table salt in accordance with 
good manufacturing or feeding practice.



Sec. 582.2227  Calcium silicate.

    (a) Product. Calcium silicate.
    (b) Tolerance. 2 percent and 5 percent.
    (c) Limitations, restrictions, or explanation. This substance is 
generally recognized as safe when used at levels not exceeding 2 percent 
in table salt and 5 percent in baking powder in accordance with good 
manufacturing or feeding practice.



Sec. 582.2437  Magnesium silicate.

    (a) Product. Magnesium silicate.
    (b) Tolerance. 2 percent.
    (c) Limitations, restrictions, or explanation. This substance is 
generally recognized as safe when used in table salt in accordance with 
good manufacturing or feeding practice.



Sec. 582.2727  Sodium aluminosilicate.

    (a) Product. Sodium aluminosilicate (sodium silicoaluminate).
    (b) Tolerance. This substance is generally recognized as safe for 
use at a level not exceeding 2 percent in accordance with good 
manufacturing or feeding practice.



Sec. 582.2729  Hydrated sodium calcium aluminosilicate.

    (a) Product. Hydrated sodium calcium aluminosilicate (sodium calcium 
silicoaluminate).

[[Page 595]]

    (b) Tolerance. This substance is generally recognized as safe for 
use at a level not exceeding 2 percent in accordance with good 
manufacturing or feeding practice.



Sec. 582.2906  Tricalcium silicate.

    (a) Product. Tricalcium silicate.
    (b) Tolerance. 2 percent.
    (c) Limitations, restrictions, or explanation. This substance is 
generally recognized as safe when used in table salt in accordance with 
good manufacturing or feeding practice.



                    Subpart D_Chemical Preservatives



Sec. 582.3013  Ascorbic acid.

    (a) Product. Ascorbic acid.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.3021  Benzoic acid.

    (a) Product. Benzoic acid.
    (b) Tolerance. This substance is generally recognized as safe for 
use at a level not exceeding 0.1 percent in accordance with good 
manufacturing or feeding practice.



Sec. 582.3041  Erythorbic acid.

    (a) Product. Erythorbic acid.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.3081  Propionic acid.

    (a) Product. Propionic acid.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.3089  Sorbic acid.

    (a) Product. Sorbic acid.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.3109  Thiodipropionic acid.

    (a) Product. Thiodipropionic acid.
    (b) Tolerance. This substance is generally recognized as safe for 
use in food when the total content of antioxidants is not over 0.02 
percent of fat or oil content including essential (volatile) oil content 
of the food, provided the substance is used in accordance with good 
manufacturing or feeding practice.



Sec. 582.3149  Ascorbyl palmitate.

    (a) Product. Ascorbyl palmitate.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.3169  Butylated hydroxyanisole.

    (a) Product. Butylated hydroxyanisole.
    (b) Tolerance. This substance is generally recognized as safe for 
use in food when the total content of antioxidants is not over 0.02 
percent of fat or oil content, including essential (volatile) oil 
content of food provided the substance is used in accordance with good 
manufacturing or feeding practice.



Sec. 582.3173  Butylated hydroxytoluene.

    (a) Product. Butylated hydroxytol- uene.
    (b) Tolerance. This substance is generally recognized as safe for 
use in food when the total content of antioxidants is not over 0.02 
percent of fat or oil content, including essential (volatile) oil 
content of food provided the substance is used in accordance with good 
manufacturing or feeding practice.



Sec. 582.3189  Calcium ascorbate.

    (a) Product. Calcium ascorbate.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.3221  Calcium propionate.

    (a) Product. Calcium propionate.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.3225  Calcium sorbate.

    (a) Product. Calcium sorbate.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.

[[Page 596]]



Sec. 582.3280  Dilauryl thiodipropionate.

    (a) Product. Dilauryl thiodipropionate.
    (b) Tolerance. This substance is generally recognized as safe for 
use in food when the total content of antioxidants is not over 0.02 
percent of fat or oil content, including essential (volatile) oil 
content of the food, provided the substance is used in accordance with 
good manufacturing or feeding practice.



Sec. 582.3336  Gum guaiac.

    (a) Product. Gum guaiac.
    (b) Tolerance. 0.1 percent (equivalent antioxidant activity 0.01 
percent).
    (c) Limitations, restrictions, or explanation. This substance is 
generally recognized as safe when used in edible fats or oils in 
accordance with good manufacturing or feeding practice.



Sec. 582.3490  Methylparaben.

    (a) Product. Methylparaben (methyl p-hydroxybenzoate).
    (b) Tolerance. This substance is generally recognized as safe for 
use at a level not exceeding 0.1 percent in accordance with good 
manufacturing or feeding practice.



Sec. 582.3616  Potassium bisulfite.

    (a) Product. Potassium bisulfite.
    (b) [Reserved]
    (c) Limitations, restrictions, or explanation. This substance is 
generally recognized as safe when used in accordance with good 
manufacturing or feeding practice, except that it is not used in meats 
or in food recognized as source of vitamin B1.



Sec. 582.3637  Potassium metabisulfite.

    (a) Product. Potassium metabisulfite.
    (b) [Reserved]
    (c) Limitations, restrictions, or explanation. This substance is 
generally recognized as safe when used in accordance with good 
manufacturing or feeding practice, except that it is not used in meats 
or in food recognized as source of vitamin B1.



Sec. 582.3640  Potassium sorbate.

    (a) Product. Potassium sorbate.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.3660  Propyl gallate.

    (a) Product. Propyl gallate.
    (b) Tolerance. This substance is generally recognized as safe for 
use in food when the total content of antioxidants is not over 0.02 
percent of fat or oil content, including essential (volatile) oil 
content of the food, provided the substance is used in accordance with 
good manufacturing or feeding practice.



Sec. 582.3670  Propylparaben.

    (a) Product. Propylparaben (propyl p-hydroxybenzoate).
    (b) Tolerance. This substance is generally recognized as safe for 
use at a level not exceeding 0.1 percent in accordance with good 
manufacturing or feeding practice.



Sec. 582.3731  Sodium ascorbate.

    (a) Product. Sodium ascorbate.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.3733  Sodium benzoate.

    (a) Product. Sodium benzoate.
    (b) Tolerance. This substance is generally recognized as safe for 
use at a level not exceeding 0.1 percent in accordance with good 
manufacturing or feeding practice.



Sec. 582.3739  Sodium bisulfite.

    (a) Product. Sodium bisulfite.
    (b) [Reserved]
    (c) Limitations, restrictions, or explanation. This substance is 
generally recognized as safe when used in accordance with good 
manufacturing or feeding practice, except that it is not used in meats 
or in food recognized as source of vitamin B1.



Sec. 582.3766  Sodium metabisulfite.

    (a) Product. Sodium metabisulfite.
    (b) [Reserved]
    (c) Limitations, restrictions, or explanation. This substance is 
generally recognized as safe when used in accordance with good 
manufacturing or feeding practice, except that it is not used

[[Page 597]]

in meats or in food recognized as source of vitamin B1.



Sec. 582.3784  Sodium propionate.

    (a) Product. Sodium propionate.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.3795  Sodium sorbate.

    (a) Product. Sodium sorbate.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.3798  Sodium sulfite.

    (a) Product. Sodium sulfite.
    (b) [Reserved]
    (c) Limitations, restrictions, or explanation. This substance is 
generally recognized as safe when used in accordance with good 
manufacturing or feeding practice, except that it is not used in meats 
or in food recognized as source of vitamin B1.



Sec. 582.3845  Stannous chloride.

    (a) Product. Stannous chloride.
    (b) Tolerance. This substance is generally recognized as safe for 
use at a level not exceeding 0.0015 percent calculated as tin in 
accordance with good manufacturing or feeding practice.



Sec. 582.3862  Sulfur dioxide.

    (a) Product. Sulfur dioxide.
    (b) [Reserved]
    (c) Limitations, restrictions, or explanation. This substance is 
generally recognized as safe when used in accordance with good 
manufacturing or feeding practice, except that it is not used in meats 
or in food recognized as source of vitamin B1.



Sec. 582.3890  Tocopherols.

    (a) Product. Tocopherols.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



                      Subpart E_Emulsifying Agents



Sec. 582.4101  Diacetyl tartaric acid esters of mono- and diglycerides
of edible fats or oils, or edible fat-forming fatty acids.

    (a) Product. Diacetyl tartaric acid esters of mono- and diglycerides 
of edible fats or oils, or edible fat-forming fatty acids.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.4505  Mono- and diglycerides of edible fats or oils,
or edible fat-forming acids.

    (a) Product. Mono- and diglycerides of edible fats or oils, or 
edible fat-forming acids.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.4521  Monosodium phosphate derivatives of mono- and 
diglycerides of edible fats or oils, or edible fat-forming 
fatty acids.

    (a) Product. Monosodium phosphate derivatives of mono- and 
diglycerides of edible fats or oils, or edible fat-forming fatty acids.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.4666  Propylene glycol.

    (a) Product. Propylene glycol.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



           Subpart F_Nutrients and/or Dietary Supplements \1\



Sec. 582.5013  Ascorbic acid.

    (a) Product. Ascorbic acid.
---------------------------------------------------------------------------

    \1\ Amino acids listed in this subpart may be free hydrochloride 
salt, hydrated, or anhydrous form, where applicable.
---------------------------------------------------------------------------

    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.

[[Page 598]]



Sec. 582.5017  Aspartic acid.

    (a) Product. Aspartic acid (L- and DL-forms).
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.5049  Aminoacetic acid.

    (a) Product. Glycine (aminoacetic acid).
    (b) [Reserved]
    (c) Limitations, restrictions, or explanation. This substance is 
generally recognized as safe when used in animal feeds in accordance 
with good manufacturing or feeding practice.



Sec. 582.5065  Linoleic acid.

    (a) Product. Linoleic acid prepared from edible fats and oils and 
free from chick-edema factor.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.5118  Alanine.

    (a) Product. Alanine (L- and DL-forms).
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.5145  Arginine.

    (a) Product. Arginine (L- and DL-forms).
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.5159  Biotin.

    (a) Product. Biotin.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.5191  Calcium carbonate.

    (a) Product. Calcium carbonate.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.5195  Calcium citrate.

    (a) Product. Calcium citrate.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.5201  Calcium glycerophosphate.

    (a) Product. Calcium glycerophosphate.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.5210  Calcium oxide.

    (a) Product. Calcium oxide.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.5212  Calcium pantothenate.

    (a) Product. Calcium pantothenate.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.5217  Calcium phosphate.

    (a) Product. Calcium phosphate (mono-, di-, and tribasic).
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.5223  Calcium pyrophosphate.

    (a) Product. Calcium pyrophosphate.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.5230  Calcium sulfate.

    (a) Product. Calcium sulfate.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.5245  Carotene.

    (a) Product. Carotene.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.

[[Page 599]]



Sec. 582.5250  Choline bitartrate.

    (a) Product. Choline bitartrate.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.5252  Choline chloride.

    (a) Product. Choline chloride.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.5260  Copper gluconate.

    (a) Product. Copper gluconate.
    (b) Tolerance. This substance is generally recognized as safe for 
use at a level not exceeding 0.005 percent in accordance with good 
manufacturing or feeding practice.



Sec. 582.5271  Cysteine.

    (a) Product. Cysteine (L-forms).
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.5273  Cystine.

    (a) Product. Cystine (L- and DL-forms).
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.5301  Ferric phosphate.

    (a) Product. Ferric phosphate.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.5304  Ferric pyrophosphate.

    (a) Product. Ferric pyrophosphate.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.5306  Ferric sodium pyrophosphate.

    (a) Product. Ferric sodium pyrophosphate.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.5308  Ferrous gluconate.

    (a) Product. Ferrous gluconate.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.5311  Ferrous lactate.

    (a) Product. Ferrous lactate.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.5315  Ferrous sulfate.

    (a) Product. Ferrous sulfate.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.5361  Histidine.

    (a) Product. Histidine (L- and DL-forms).
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.5370  Inositol.

    (a) Product. Inositol.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.5375  Iron reduced.

    (a) Product. Iron reduced.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.5381  Isoleucine.

    (a) Product. Isoleucine (L- and DL-forms).
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.5406  Leucine.

    (a) Product. Leucine (L- and DL-forms).

[[Page 600]]

    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.5411  Lysine.

    (a) Product. Lysine (L- and DL-forms).
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.5431  Magnesium oxide.

    (a) Product. Magnesium oxide.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.5434  Magnesium phosphate.

    (a) Product. Magnesium phosphate (di- and tribasic).
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.5443  Magnesium sulfate.

    (a) Product. Magnesium sulfate.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.5446  Manganese chloride.

    (a) Product. Manganese chloride.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.5449  Manganese citrate.

    (a) Product. Manganese citrate.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.5452  Manganese gluconate.

    (a) Product. Manganese gluconate.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.5455  Manganese glycerophosphate.

    (a) Product. Manganese glycerophosphate.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.5458  Manganese hypophosphite.

    (a) Product. Manganese hypophosphite.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.5461  Manganese sulfate.

    (a) Product. Manganese sulfate.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.5464  Manganous oxide.

    (a) Product. Manganous oxide.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.5470  Mannitol.

    (a) Product. Mannitol.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.5475  Methionine.

    (a) Product. Methionine.
    (b) [Reserved]
    (c) Limitations, restrictions, or explanation. This substance is 
generally recognized as safe when used in animal feeds in accordance 
with good manufacturing or feeding practice.



Sec. 582.5477  Methionine hydroxy analog and its calcium salts.

    (a) Product. Methionine hydroxy analog and its calcium salts.
    (b) [Reserved]
    (c) Limitations, restrictions, or explanation. This substance is 
generally recognized as safe when used in animal feeds in accordance 
with good manufacturing or feeding practice.

[[Page 601]]



Sec. 582.5530  Niacin.

    (a) Product. Niacin.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.5535  Niacinamide.

    (a) Product. Niacinamide.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.5580  D-Pantothenyl alcohol.

    (a) Product. D-Pantothenyl alcohol.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.5590  Phenylalanine.

    (a) Product. Phenylalanine (L- and DL-forms).
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.5622  Potassium chloride.

    (a) Product. Potassium chloride.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.5628  Potassium glycerophosphate.

    (a) Product. Potassium glycerophosphate.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.5634  Potassium iodide.

    (a) Product. Potassium iodide.
    (b) Tolerance. 0.01 percent.
    (c) Limitations, restrictions, or explanation. This substance is 
generally recognized as safe when used in table salt as a source of 
dietary iodine in accordance with good manufacturing or feeding 
practice.



Sec. 582.5650  Proline.

    (a) Product. Proline (L- and DL-forms).
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.5676  Pyridoxine hydrochloride.

    (a) Product. Pyridoxine hydrochloride.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.5695  Riboflavin.

    (a) Product. Riboflavin.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.5697  Riboflavin-5-phosphate.

    (a) Product. Riboflavin-5-phosphate.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.5701  Serine.

    (a) Product. Serine (L- and DL-forms).
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.5772  Sodium pantothenate.

    (a) Product. Sodium pantothenate.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.5778  Sodium phosphate.

    (a) Product. Sodium phosphate (mono-, di-, and tribasic).
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.5835  Sorbitol.

    (a) Product. Sorbitol.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.5875  Thiamine hydrochloride.

    (a) Product. Thiamine hydrochloride.

[[Page 602]]

    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.5878  Thiamine mononitrate.

    (a) Product. Thiamine mononitrate.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.5881  Threonine.

    (a) Product. Threonine (L- and DL-forms).
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.5890  Tocopherols.

    (a) Product. Tocopherols.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.5892  a-Tocopherol acetate.

    (a) Product. a-Tocopherol acetate.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.5915  Tryptophane.

    (a) Product. Tryptophane (L- and DL-forms).
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.5920  Tyrosine.

    (a) Product. Tyrosine (L- and DL-forms).
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.5925  Valine.

    (a) Product. Valine (L- and DL-forms).
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.5930  Vitamin A.

    (a) Product. Vitamin A.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.5933  Vitamin A acetate.

    (a) Product. Vitamin A acetate.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.5936  Vitamin A palmitate.

    (a) Product. Vitamin A palmitate.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.5945  Vitamin B12.

    (a) Product. Vitamin B12.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.5950  Vitamin D2.

    (a) Product. Vitamin D2.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.5953  Vitamin D3.

    (a) Product. Vitamin D3.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.5985  Zinc chloride.

    (a) Product. Zinc chloride.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.5988  Zinc gluconate.

    (a) Product. Zinc gluconate.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.5991  Zinc oxide.

    (a) Product. Zinc oxide.

[[Page 603]]

    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.5994  Zinc stearate.

    (a) Product. Zinc stearate prepared from stearic acid free from 
chick-edema factor.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.5997  Zinc sulfate.

    (a) Product. Zinc sulfate.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



                       Subpart G_Sequestrants \2\



Sec. 582.6033  Citric acid.

    (a) Product. Citric acid.
---------------------------------------------------------------------------

    \2\ For the purpose of this subpart, no attempt has been made to 
designate those sequestrants that may also function as chemical 
preservatives.
---------------------------------------------------------------------------

    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.6085  Sodium acid phosphate.

    (a) Product. Sodium acid phosphate.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.6099  Tartaric acid.

    (a) Product. Tartaric acid.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.6185  Calcium acetate.

    (a) Product. Calcium acetate.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.6193  Calcium chloride.

    (a) Product. Calcium chloride.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.6195  Calcium citrate.

    (a) Product. Calcium citrate.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.6197  Calcium diacetate.

    (a) Product. Calcium diacetate.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.6199  Calcium gluconate.

    (a) Product. Calcium gluconate.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.6203  Calcium hexametaphosphate.

    (a) Product. Calcium hexametaphosphate.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.6215  Monobasic calcium phosphate.

    (a) Product. Monobasic calcium phosphate.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.6219  Calcium phytate.

    (a) Product. Calcium phytate.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.6285  Dipotassium phosphate.

    (a) Product. Dipotassium phosphate.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.

[[Page 604]]



Sec. 582.6290  Disodium phosphate.

    (a) Product. Disodium phosphate.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.6386  Isopropyl citrate.

    (a) Product. Isopropyl citrate.
    (b) Tolerance. This substance is generally recognized as safe for 
use at a level not exceeding 0.02 percent in accordance with good 
manufacturing or feeding practice.



Sec. 582.6511  Monoisopropyl citrate.

    (a) Product. Monoisopropyl citrate.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.6625  Potassium citrate.

    (a) Product. Potassium citrate.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.

[41 FR 38657, Sept. 10, 1976. Redesignated at 42 FR 14091, Mar. 15, 
1977]



Sec. 582.6751  Sodium citrate.

    (a) Product. Sodium citrate.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.

[41 FR 38657, Sept. 10, 1976. Redesignated at 42 FR 14091, Mar. 15, 
1977]



Sec. 582.6754  Sodium diacetate.

    (a) Product. Sodium diacetate.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.6757  Sodium gluconate.

    (a) Product. Sodium gluconate.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.6760  Sodium hexametaphosphate.

    (a) Product. Sodium hexametaphosphate.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.6769  Sodium metaphosphate.

    (a) Product. Sodium metaphosphate.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.6778  Sodium phosphate.

    (a) Product. Sodium phosphate (mono-, di-, and tribasic).
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.6787  Sodium pyrophosphate.

    (a) Product. Sodium pyrophosphate.
    (b) Condition of use. This substance is generally recognized as safe 
when used in accordance with good manufacturing or feeding practice.



Sec. 582.6789  Tetra sodium pyrophosphate.

    (a) Product. Tetra sodium pyrophosphate.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.6801  Sodium tartrate.

    (a) Product. Sodium tartrate.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.6804  Sodium potassium tartrate.

    (a) Product. Sodium potassium tartrate.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.6807  Sodium thiosulfate.

    (a) Product. Sodium thiosulfate.
    (b) Tolerance. 0.1 percent.
    (c) Limitations, restrictions, or explanation. This substance is 
generally recognized as safe when used in salt in accordance with good 
manufacturing or feeding practice.

[[Page 605]]



Sec. 582.6810  Sodium tripolyphosphate.

    (a) Product. Sodium tripolyphosphate.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.6851  Stearyl citrate.

    (a) Product. Stearyl citrate.
    (b) Tolerance. This substance is generally recognized as safe for 
use at a level not exceeding 0.15 percent in accordance with good 
manufacturing or feeding practice.



                          Subpart H_Stabilizers



Sec. 582.7115  Agar-agar.

    (a) Product. Agar-agar.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.7133  Ammonium alginate.

    (a) Product. Ammonium alginate.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.7187  Calcium alginate.

    (a) Product. Calcium alginate.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.7255  Chondrus extract.

    (a) Product. Chondrus extract (carrageenin).
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.7330  Gum arabic.

    (a) Product. Acacia (gum arabic).
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.7333  Gum ghatti.

    (a) Product. Gum ghatti.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.7339  Guar gum.

    (a) Product. Guar gum.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.7343  Locust bean gum.

    (a) Product. Locust (carob) bean gum.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.7349  Sterculia gum.

    (a) Product. Sterculia gum (karaya gum).
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.7351  Gum tragacanth.

    (a) Product. Tragacanth (gum tragacanth).
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.7610  Potassium alginate.

    (a) Product. Potassium alginate.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



Sec. 582.7724  Sodium alginate.

    (a) Product. Sodium alginate.
    (b) Conditions of use. This substance is generally recognized as 
safe when used in accordance with good manufacturing or feeding 
practice.



PART 584_FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE
IN FEED AND DRINKING WATER OF ANIMALS--Table of Contents



Subpart A [Reserved]

[[Page 606]]

        Subpart B_Listing of Specific Substances Affirmed as GRAS

Sec.
584.200 Ethyl alcohol containing ethyl acetate.
584.700 Hydrophobic silicas.
584.725 25-Hydroxyvitamin D3.

    Authority: 21 U.S.C. 321, 342, 348, 371.

Subpart A [Reserved]



        Subpart B_Listing of Specific Substances Affirmed as GRAS



Sec. 584.200  Ethyl alcohol containing ethyl acetate.

    The feed additive ethyl alcohol containing ethyl acetate meets the 
requirement of 27 CFR 21.62, being not less than 92.5 percent ethyl 
alcohol, each 100 gallons having had added the equivalent of 4.25 
gallons of 100 percent ethyl acetate. It is used in accordance with good 
feeding practices in ruminant feed supplements as a source of added 
energy.

[46 FR 52333, Oct. 27, 1981, as amended at 72 FR 41620, July 31, 2007]



Sec. 584.700  Hydrophobic silicas.

    (a) Product. Amorphous fumed hydrophobic silica or precipitated 
hydrophobic silica (CAS Reg. No. 68611-0944-099, silane, 
dichlorodimethyl-, reaction products with silica).
    (b) Conditions of use. An anticaking/free-flow agent in vitamin 
preparations for animal feed.
    (c) Limitations. Not to exceed 5 percent in the vitamin preparation. 
It shall be used in accordance with good manufacturing or feeding 
practices. It must be of purity suitable for intended use, and it must 
comply with the following specifications:
    (i) Amorphous fumed hydrophobic silica: Not less than 99.0 percent 
silicon dioxide after ignition. Not more than 3 ppm arsenic. Not more 
than 0.003 percent heavy metals (as lead). Not more than 10 ppm lead. 
Not more than 2.5 percent loss on drying. Not more than 2 percent loss 
on ignition after drying. Not more than 1 percent insoluble substances. 
Not more than 50 parts per million dichlorodimethylsilane.
    (ii) Precipated hydrophobic silica: Not less than 94.0 percent 
silicon dioxide after ignition. Not more than 3 ppm arsenic. Not more 
than 0.003 percent heavy metals (as lead). Not more than 10 ppm lead. 
Not more than 7 percent loss on drying. Not more than 8.5 percent loss 
on ignition after drying. Not more than 5 percent soluble ionizable 
salts (as sodium sulfate). Not more than 1 percent insoluble substances. 
Not more than 50 parts per million dichlorodimethylsilane.

[61 FR 43453, Aug. 23, 1996]



Sec. 584.725  25-Hydroxyvitamin D3.

    (a) Product. 25-Hydroxyvitamin D3 (9,10-secocholesta-
5,7,10(19)-triene-3[beta], 25-diol).
    (b) Conditions of use. This substance is generally recognized as 
safe as a source of vitamin D3 activity in feed or drinking 
water of broiler chickens when used in accordance with the limitations 
in paragraph (c) of this section.
    (c) Limitations. (1) Not to exceed 69 parts per billion (ppb) in 
feed or 34.5 ppb in drinking water. It shall be used in accordance with 
good manufacturing and feeding practices.
    (2) The product must comply with the following specifications:
    (i) Not less than 94.0 percent 25-hydroxyvitamin D3.
    (ii) Not more than 1 percent of any individual sterol.
    (iii) Not more than 5 percent water.
    (iv) Not more than 20 parts per million (ppm) lead.
    (v) Not more than 20 ppm aluminum.
    (vi) Not more than 1.0 percent solvents and non-detectable levels of 
2'. 4'. 5'. 7'-tetraiodofluorescin.
    (3) Product labeling shall bear the following:
    (i) A statement to indicate that the maximum use level of 25-
hydroxyvitamin D3 must not exceed 69 ppb in feed or 34.5 ppb 
in drinking water.
    (ii) Adequate use directions to ensure that 25-hydroxyvitamin 
D3 (and all premixes) is uniformly blended throughout the 
feed or drinking water.
    (iii) An expiration date on all premix labeling.
    (iv) A statement on all premix labeling (feed and drinking water 
forms) that 25-hydroxyvitamin D3 should not

[[Page 607]]

be used simultaneously in both feed and water.

[72 FR 12564, Mar. 16, 2007]



PART 589_SUBSTANCES PROHIBITED FROM USE IN ANIMAL FOOD OR FEED
--Table of Contents



                      Subpart A_General Provisions

Sec.
589.1 Substances prohibited from use in animal food or feed.

 Subpart B_Listing of Specific Substances Prohibited From Use in Animal 
                              Food or Feed

589.1000 Gentian violet.
589.1001 Propylene glycol in or on cat food.
589.2000 Animal proteins prohibited in ruminant feed.
589.2001 Cattle materials prohibited in animal food or feed to prevent 
          the transmission of bovine spongiform encephalopathy.

    Authority: 21 U.S.C. 321, 342, 343, 348, 371.



                      Subpart A_General Provisions



Sec. 589.1  Substances prohibited from use in animal food or feed.

    (a) The substances listed in this part have been prohibited from use 
in animal food or feed by the Food and Drug Administration because of a 
determination that they present a potential risk to the public health or 
have not been shown by adequate scientific data to be safe for use in 
such food or feed. Use of any of these substances in violation of this 
part causes the animal food or feed involved to be adulterated and in 
violation of the Act.
    (b) This part includes only a partial list of substances prohibited 
from use in animal food or feed; it is for easy reference purposes and 
is not a complete list of substances that may not lawfully be used in 
such animal food or feed. No substance may be used in animal food or 
feed unless it meets all applicable requirements of the Act.
    (c) The Food and Drug Administration either on its own initiative or 
on behalf of any interested person who has submitted a petition, may 
publish a proposal to establish, amend, or repeal a regulation under 
this part on the basis of new scientific evaluation or information. Any 
such petition shall include an adequate scientific basis to support the 
petition, shall be the form set forth in Sec. 571.1 of this chapter, 
and will be published in the Federal Register for comment if it contains 
reasonable ground.

[45 FR 28319, Apr. 29, 1980]



 Subpart B_Listing of Specific Substances Prohibited From Use in Animal 
                              Food or Feed



Sec. 589.1000  Gentian violet.

    The Food and Drug Administration has determined that gentian violet 
has not been shown by adequate scientific data to be safe for use in 
animal feed. Use of gentian violet in animal feed causes the feed to be 
adulterated and in violation of the Federal Food, Drug, and Cosmetic Act 
(the act), in the absence of a regulation providing for its safe use as 
a food additive under section 409 of the act, unless it is subject to an 
effective notice of claimed investigational exemption for a food 
additive under Sec. 570.17 of this chapter, or unless the substance is 
intended for use as a new animal drug and is subject to an approved 
application under section 512 of the act, or an index listing under 
section 572 of the act, or an effective notice of claimed 
investigational exemption for a new animal drug under part 511 of this 
chapter or Sec. 516.125 of this chapter.

[72 FR 69131, Dec. 6, 2007]



Sec. 589.1001  Propylene glycol in or on cat food.

    The Food and Drug Administration has determined that propylene 
glycol in or on cat food has not been shown by adequate scientific data 
to be safe for use. Use of propylene glycol in or on cat food causes the 
feed to be adulterated and in violation of the Federal Food, Drug, and 
Cosmetic Act (the act), in the absence of a regulation providing for its 
safe use as a food additive under section 409 of the act, unless it is 
subject to an effective notice of claimed investigational exemption for 
a food additive under Sec. 570.17 of this chapter, or unless the 
substance is intended for use as a new animal drug

[[Page 608]]

and is subject to an approved application under section 512 of the act 
or an effective notice of claimed investigational exemption for a new 
animal drug under part 511 of this chapter.

[61 FR 19544, May 2, 1996]



Sec. 589.2000  Animal proteins prohibited in ruminant feed.

    (a) Definitions--(1) Protein derived from mammalian tissues means 
any protein-containing portion of mammalian animals, excluding: Blood 
and blood products; gelatin; tallow containing no more than 0.15 percent 
insoluble impurities and tallow derivatives as specified in Sec. 
589.2001; inspected meat products which have been cooked and offered for 
human food and further heat processed for feed (such as plate waste and 
used cellulosic food casings); milk products (milk and milk proteins); 
and any product whose only mammalian protein consists entirely of 
porcine or equine protein.
    (2) Renderer means any firm or individual that processes slaughter 
byproducts, animals unfit for human consumption, or meat scraps. The 
term includes persons who collect such materials and subject them to 
minimal processing, or distribute them to firms other than renderers (as 
defined here) whose intended use for the products may include animal 
feed. The term includes renderers that also blend animal protein 
products.
    (3) Blender means any firm or individual which obtains processed 
animal protein from more than one source or from more than one species, 
and subsequently mixes (blends) or redistributes an animal protein 
product.
    (4) Feed manufacturer includes manufacturers of complete and 
intermediate feeds intended for animals, and includes on-farm in 
addition to off-farm feed manufacturing and mixing operations.
    (5) Nonmammalian protein includes proteins from nonmammalian 
animals.
    (6) Distributor includes persons who distribute or transport feeds 
or feed ingredients intended for animals.
    (7) Ruminant includes any member of the order of animals which has a 
stomach with four chambers (rumen, reticulum, omasum, and abomasum) 
through which feed passes in digestion. The order includes, but is not 
limited to, cattle, buffalo, sheep, goats, deer, elk, and antelopes.
    (b) Food additive status. The Food and Drug Administration has 
determined that protein derived from mammalian tissues for use in 
ruminant feed is a food additive subject to section 409 of the Federal 
Food, Drug, and Cosmetic Act (the act). The use or intended use in 
ruminant feed of any material that contains protein derived from 
mammalian tissues causes the feed to be adulterated and in violation of 
the act, unless it is the subject of an effective notice of claimed 
investigational exemption for a food additive under Sec. 570.17 of this 
chapter.
    (c) Requirements for renderers that are not included in paragraph 
(e) of this section. (1) Renderers that manufacture products that 
contain or may contain protein derived from mammalian tissues and that 
are intended for use in animal feed shall take the following measures to 
ensure that materials identified in paragraph (b) of this section are 
not used in the feed of ruminants:
    (i) Label the materials as follows: ``Do not feed to cattle or other 
ruminants''; and
    (ii) Maintain records sufficient to track the materials throughout 
their receipt, processing, and distribution, and make the copies 
available for inspection and copying by the Food and Drug 
Administration.
    (2) Renderers described in paragraph (c)(1) of this section will be 
exempted from the requirements of paragraphs (c)(1)(i) and (c)(1)(ii) of 
this section if they:
    (i) Use exclusively a manufacturing method that has been validated 
by the Food and Drug Administration to deactivate the agent that causes 
transmissible spongiform encephalopathy (TSE) and whose design has been 
made available to the public;
    (ii) Use routinely a test method that has been validated by the Food 
and Drug Administration to detect the presence of the agent that causes 
TSE's and whose design has been made available to the public. Renderers 
whose products test positive for agents that cause TSE's must comply 
with paragraphs (c)(1)(i) and (c)(1)(ii) of this

[[Page 609]]

section. Records of the test results shall be made available for 
inspection by the Food and Drug Administration; or
    (iii) Use exclusively a method for controlling the manufacturing 
process that minimizes the risk of the TSE agent entering the product 
and whose design has been made available to the public and validated by 
the Food and Drug Administration.
    (3) Renderers described in paragraph (c)(1) of this section will be 
exempted from the requirements of paragraph (c)(1)(ii) of this section 
if they use a permanent method, approved by FDA, to make a mark 
indicating that the product contains or may contain protein derived from 
mammalian tissue. If the marking is by the use of an agent that cannot 
be detected on visual inspection, the renderer must use an agent whose 
presence can be detected by a method that has been validated by the Food 
and Drug Administration and whose design has been made available to the 
public.
    (4) Renderers shall comply with all applicable requirements under 
Sec. 589.2001.
    (d) Requirements for protein blenders, feed manufacturers, and 
distributors that are not included in paragraph (e) of this section. (1) 
Protein blenders, feed manufacturers, and distributors that manufacture, 
blend, process, and distribute products that contain or may contain 
protein derived from mammalian tissues shall comply with paragraph 
(c)(1) of this section.
    (2) Protein blenders, feed manufacturers, and distributors, shall be 
exempt from paragraphs (d)(1) of this section if they:
    (i) Purchase animal products from renderers that certified 
compliance with paragraph (c)(2) of this section or purchase such 
materials from parties that certify that the materials were purchased 
from renderers that certified compliance with paragraph (c)(2) of this 
section; or
    (ii) Comply with the requirements of paragraph (c)(2) of this 
section where appropriate.
    (3) Protein blenders, feed manufacturers, and distributors, shall be 
exempt from paragraph (c)(1)(ii) of this section if they:
    (i) Purchase animal protein products that are marked in accordance 
with paragraph (c)(3) of this section or purchase such materials from 
renderers that certified compliance with paragraph (c)(3) of this 
section, or purchase such materials from parties that certify that the 
materials were purchased from renderers that certified compliance with 
paragraph (c)(3) of this section; or
    (ii) Comply with the requirements of paragraph (c)(3) of this 
section where appropriate.
    (4) Pet food products that are sold or are intended for sale at 
retail and feeds for nonruminant laboratory animals are exempt from the 
labeling requirements in paragraphs (c) and (d) of this section. 
However, if the pet food products or feeds for nonruminant laboratory 
animals are sold or are intended for sale as distressed or salvage 
items, then such products shall be labeled in accordance with paragraph 
(c) or (d) of this section, as appropriate.
    (5) Copies of certifications as described in paragraphs (d)(2) and 
(d)(3) of this section, shall be made available for inspection and 
copying by the Food and Drug Administration.
    (e) Requirements for persons that intend to separate mammalian and 
nonmammalian materials. (1) Renderers, protein blenders, feed 
manufacturers, distributors, and others that manufacture, process, blend 
and distribute both products that contain or may contain protein derived 
from mammalian tissues or feeds containing such products, and protein 
products from other animal tissues or feeds containing such products, 
and that intend to keep those products separate shall:
    (i) Comply with paragraphs (c)(1) or (d)(1) of this section as 
appropriate except that the labeling requirement shall apply only to 
products that contain or may contain protein derived from mammalian 
tissues or feeds containing such products;
    (ii) In the case of a renderer, obtain nonmammalian or pure porcine 
or pure equine materials only from single-species slaughter facilities;
    (iii) Provide for measures to avoid commingling or cross-
contamination;

[[Page 610]]

    (A) Maintain separate equipment or facilities for the manufacture, 
processing, or blending of such materials; or
    (B) Use clean-out procedures or other means adequate to prevent 
carry-over of products that contain or may contain protein derived from 
mammalian tissues into animal protein or feeds that may be used for 
ruminants; and
    (iv) Maintain written procedures specifying the clean-out procedures 
or other means, and specifying the procedures for separating products 
that contain or may contain protein derived from mammalian tissue from 
all other protein products from the time of receipt until the time of 
shipment.
    (2) Renderers, blenders, feed manufacturers, and distributors will 
be exempted from applicable requirements of paragraph (e)(1) of this 
section, if they meet the criteria for exemption under paragraphs (c)(2) 
or (c)(3) of this section, and (d)(2) or (d)(3) of this section.
    (3) Renderers shall comply with all applicable requirements under 
Sec. 589.2001.
    (f) Requirements for establishments and individuals that are 
responsible for feeding ruminant animals. Establishments and individuals 
that are responsible for feeding ruminant animals shall maintain copies 
of purchase invoices and labeling for all feeds containing animal 
protein products received, and make the copies available for inspection 
and copying by the Food and Drug Administration.
    (g) Adulteration and misbranding. (1) Animal protein products, and 
feeds containing such products, that are not in compliance with 
paragraphs (c) through (f) of this section, excluding labeling 
requirements, will be deemed adulterated under section 402(a)(2)(C) or 
402(a)(4) of the act.
    (2) Animal protein products, and feeds containing such products, 
that are not in compliance with the labeling requirements of paragraphs 
(c) through (f) of this section will be deemed misbranded under section 
403(a)(1) or 403(f) of the act.
    (h) Inspection; records retention. (1) Records that are to be made 
available for inspection and copying, as required by this section, shall 
be kept for a minimum of 1 year.
    (2) Written procedures required by this section shall be made 
available for inspection and copying by the Food and Drug 
Administration.

[62 FR 30976, June 5, 1997, as amended at 73 FR 22756, Apr. 25, 2008]

    Effective Date Note: At 62 FR 30976, June 5, 1997, Sec. 589.2000 
was added. Paragraph (e)(1)(iv) of this section contains information 
collection and recordkeeping requirements and will not become effective 
until approval has been given by the Office of Management and Budget.



Sec. 589.2001  Cattle materials prohibited in animal food or feed to
prevent the transmission of bovine spongiform encephalopathy.

    (a) Purpose. The purpose of this section is to prohibit the use of 
certain cattle origin materials in the food or feed of all animals to 
further reduce the risk of the spread of bovine spongiform 
encephalopathy (BSE) within the United States.
    (b) Definitions--(1) Cattle materials prohibited in animal feed 
include:
    (i) The entire carcass of BSE-positive cattle;
    (ii) The brains and spinal cords of cattle 30 months of age and 
older;
    (iii) The entire carcass of cattle not inspected and passed for 
human consumption as defined in paragraph (b)(2) of this section that 
are 30 months of age or older from which brains and spinal cords were 
not effectively removed or otherwise effectively excluded from animal 
feed;
    (iv) Mechanically separated beef as defined in paragraph (b)(3) of 
this section that is derived from materials specified in paragraphs 
(b)(1)(i), (b)(1)(ii), and (b)(1)(iii) of this section; and
    (v) Tallow as defined in paragraph (b)(5) of this section that is 
derived from materials specified in paragraphs (b)(1)(i), (b)(1)(ii), 
and (b)(1)(iii) of this section.
    (vi) Cattle materials prohibited in animal feed do not include:
    (A) Tallow derivatives as defined in paragraph (b)(6) of this 
section;
    (B) Tallow as defined in paragraph (b)(5) of this section that is 
derived from materials specified in paragraphs (b)(1)(ii) and 
(b)(1)(iii) of this section

[[Page 611]]

and that contains no more than 0.15 percent insoluble impurities. 
Insoluble impurities must be measured by the method entitled ``Insoluble 
Impurities'' (AOCS Method Ca 3a-46), American Oil Chemists' Society 
(AOCS), 5th Edition, 1997, incorporated by reference in accordance with 
5 U.S.C. 552(a) and 1 CFR part 51, or another method equivalent in 
accuracy, precision, and sensitivity to AOCS Official Method Ca 3a-46. 
You may obtain copies of the method from the AOCS (http://www.aocs.org), 
2211 W. Bradley Ave., Champaign, IL 61821. Copies may be examined at the 
Food and Drug Administration's Main Library, 10903 New Hampshire Ave., 
Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039, or at the 
National Archives and Records Administration (NARA). For information on 
the availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/federal_ register/code_of_federal_regulations/
ibr_locations.html.
    (C) Materials as defined in paragraphs (b)(1)(ii), (b)(1)(iii), 
(b)(1)(iv) (other than mechanically separated beef from the carcass of a 
BSE-positive cattle), and (b)(1)(v) of this section from cattle from a 
country that has been designated under paragraph (f) of this section.
    (2) Cattle not inspected and passed for human consumption means 
cattle that did not pass antemortem inspection by the appropriate 
regulatory authority. This term includes nonambulatory disabled cattle. 
Nonambulatory disabled cattle are cattle that cannot rise from a 
recumbent position or that cannot walk, including, but not limited to, 
those with broken appendages, severed tendons or ligaments, nerve 
paralysis, fractured vertebral column, or metabolic conditions.
    (3) Mechanically separated beef means a finely comminuted meat food 
product, resulting from the mechanical separation and removal of most of 
the bone from attached skeletal muscle of cattle carcasses and parts of 
carcasses.
    (4) Renderer means any firm or individual that processes slaughter 
byproducts, animals unfit for human consumption, or meat scraps. The 
term includes persons who collect such materials and subject them to 
minimal processing, or distribute them to firms other than renderers (as 
defined in this paragraph) whose intended use for the products may 
include animal feed, industrial use, or other uses. The term includes 
renderers that also blend animal protein products.
    (5) Tallow means the rendered fat of cattle obtained by pressing or 
by applying any other extraction process to tissues derived directly 
from discrete adipose tissue masses or to other carcass parts and 
tissues.
    (6) Tallow derivative means any product obtained through initial 
hydrolysis, saponification, or trans-esterification of tallow; chemical 
conversion of material obtained by hydrolysis, saponification, or trans-
esterification may be applied to obtain the desired product.
    (c) Requirements. (1) No animal feed or feed ingredient shall be 
manufactured from, processed with, or otherwise contain, cattle 
materials prohibited in animal feed as defined in paragraph (b)(1) of 
this section.
    (2) Renderers that receive, manufacture, process, blend, or 
distribute cattle materials prohibited in animal feed as defined in 
paragraph (b)(1) of this section, or products that contain or may 
contain cattle materials prohibited in animal feed, shall take the 
following measures to ensure that materials prohibited as defined in 
paragraph (b)(1) of this section are not introduced into animal feed:
    (i) Exclude from use in animal feed the entire carcass of cattle not 
inspected and passed for human consumption as defined in paragraph 
(b)(2) of this section if:
    (A) The brain and spinal cord are not effectively removed from such 
cattle or the brain and spinal cord from such cattle are not otherwise 
effectively excluded from animal feed; and
    (B) Such cattle are 30 months of age or older.
    (ii) If renderers remove brain and spinal cord from cattle not 
inspected and passed for human consumption, or separate such animals 
based on whether or not they are 30 months of age or older, renderers 
must maintain adequate written procedures specifying how these processes 
are carried out.

[[Page 612]]

    (iii) Once cattle materials prohibited in animal feed have been 
separated from other cattle materials, provide for measures to avoid 
cross-contamination;
    (A) Use separate equipment while handling cattle materials 
prohibited in animal feed; or
    (B) Use separate containers that adequately prevent contact with 
animal feed, animal feed ingredients, or equipment surfaces;
    (iv) Label the cattle materials prohibited in animal feed and 
products that contain or may contain cattle materials prohibited in 
animal feed in a conspicuous manner as follows: ``Do not feed to 
animals'';
    (v) Mark the cattle materials prohibited in animal feed and products 
that contain or may contain cattle materials prohibited in animal feed 
with an agent that can be readily detected on visual inspection; and
    (vi) Establish and maintain records sufficient to track cattle 
materials prohibited in animal feed to ensure such material is not 
introduced into animal feed, and make the records available for 
inspection and copying by the Food and Drug Administration.
    (3) Renderers that receive, manufacture, process, blend, or 
distribute any cattle materials shall take the following measures to 
ensure that materials prohibited as defined in paragraph (b)(1) of this 
section are not used in animal feed:
    (i) Establish and maintain records sufficient to demonstrate that 
material rendered for use in animal feed was not manufactured from, 
processed with, or does not otherwise contain, cattle materials 
prohibited in animal feed and make copies of all records available for 
inspection and copying by the Food and Drug Administration. With respect 
to cattle materials obtained from establishments which have segregated 
cattle materials prohibited in animal feed, such records must 
demonstrate that establishments supplying cattle materials to the 
renderers have adequate procedures in place to effectively exclude 
cattle materials prohibited in animal feed; and these records shall be 
considered sufficient to meet this requirement if they include either:
    (A) Certification or other documentation from the supplier that 
material supplied to the renderer does not include cattle materials 
prohibited in animal feed; such certification or documentation is 
acceptable, provided that it includes a description of the segregation 
procedures used, documentation that the supplier confirms that its 
segregation procedures are in place prior to supplying any cattle 
material to the renderer, and records of the renderer's periodic review 
of the suppliers' certification or other documentation; or
    (B) Documentation of another method acceptable to FDA, such as 
third-party certification, for verifying that suppliers have effectively 
excluded cattle materials prohibited in animal feed.
    (ii) Comply with all applicable requirements under Sec. 589.2000 
regarding animal proteins prohibited in ruminant feed.
    (d) Adulteration and misbranding. (1) Failure of a renderer to 
comply with the requirements in paragraphs (c)(2)(i) through 
(c)(2)(iii), (c)(2)(v) and (c)(2)(vi), or (c)(3)(i) of this section will 
render the animal feed or feed ingredients adulterated under section 
402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the act).
    (2) Animal feed or feed ingredients that are not in compliance with 
paragraph (c)(1) of this section are adulterated under section 
402(a)(2), 402(a)(3), or 402(a)(5) of the act.
    (3) Animal feed or feed ingredients that are not in compliance with 
the labeling requirements of paragraph (c)(2)(iv) of this section are 
misbranded under section 403(a)(1) or 403(f) of the act.
    (4) Failure of a renderer to comply with the requirements in 
paragraph (e) of this section will render the animal feed or feed 
ingredients adulterated under section 402(a)(4) of the act.
    (e) Inspection; records retention. Records required to be made 
available for inspection and copying by the Food and Drug 
Administration, as required by this section, shall be kept for a minimum 
of 1 year.
    (f) Process for designating countries. A country seeking designation 
must send a written request to the Director, Office of the Center 
Director, Center for Veterinary Medicine, at the address

[[Page 613]]

designated in Sec. 5.1100 of this chapter. The request shall include 
information about that country's BSE case history, risk factors, 
measures to prevent the introduction and transmission of BSE, and any 
other information relevant to determining whether the cattle materials 
from the requesting country do or do not meet the definitions set forth 
in paragraph (b)(1) of this section. FDA shall respond in writing to any 
such request and may impose conditions in granting any such request. Any 
grant by FDA of such a request under this paragraph will be subject to 
future review by FDA and may be revoked if FDA determines that the 
granted request is no longer appropriate.

[73 FR 22756, Apr. 25, 2008, as amended at 81 FR 5596, Feb. 3, 2016]

                        PARTS 590	599 [RESERVED]

[[Page 615]]



                              FINDING AIDS




  --------------------------------------------------------------------

  A list of CFR titles, subtitles, chapters, subchapters and parts and 
an alphabetical list of agencies publishing in the CFR are included in 
the CFR Index and Finding Aids volume to the Code of Federal Regulations 
which is published separately and revised annually.


  Table of CFR Titles and Chapters
  Alphabetical List of Agencies Appearing in the CFR
  List of CFR Sections Affected

[[Page 617]]



                    Table of CFR Titles and Chapters




                      (Revised as of April 1, 2021)

                      Title 1--General Provisions

         I  Administrative Committee of the Federal Register 
                (Parts 1--49)
        II  Office of the Federal Register (Parts 50--299)
       III  Administrative Conference of the United States (Parts 
                300--399)
        IV  Miscellaneous Agencies (Parts 400--599)
        VI  National Capital Planning Commission (Parts 600--699)

                    Title 2--Grants and Agreements

            Subtitle A--Office of Management and Budget Guidance 
                for Grants and Agreements
         I  Office of Management and Budget Governmentwide 
                Guidance for Grants and Agreements (Parts 2--199)
        II  Office of Management and Budget Guidance (Parts 200--
                299)
            Subtitle B--Federal Agency Regulations for Grants and 
                Agreements
       III  Department of Health and Human Services (Parts 300--
                399)
        IV  Department of Agriculture (Parts 400--499)
        VI  Department of State (Parts 600--699)
       VII  Agency for International Development (Parts 700--799)
      VIII  Department of Veterans Affairs (Parts 800--899)
        IX  Department of Energy (Parts 900--999)
         X  Department of the Treasury (Parts 1000--1099)
        XI  Department of Defense (Parts 1100--1199)
       XII  Department of Transportation (Parts 1200--1299)
      XIII  Department of Commerce (Parts 1300--1399)
       XIV  Department of the Interior (Parts 1400--1499)
        XV  Environmental Protection Agency (Parts 1500--1599)
     XVIII  National Aeronautics and Space Administration (Parts 
                1800--1899)
        XX  United States Nuclear Regulatory Commission (Parts 
                2000--2099)
      XXII  Corporation for National and Community Service (Parts 
                2200--2299)
     XXIII  Social Security Administration (Parts 2300--2399)
      XXIV  Department of Housing and Urban Development (Parts 
                2400--2499)
       XXV  National Science Foundation (Parts 2500--2599)
      XXVI  National Archives and Records Administration (Parts 
                2600--2699)

[[Page 618]]

     XXVII  Small Business Administration (Parts 2700--2799)
    XXVIII  Department of Justice (Parts 2800--2899)
      XXIX  Department of Labor (Parts 2900--2999)
       XXX  Department of Homeland Security (Parts 3000--3099)
      XXXI  Institute of Museum and Library Services (Parts 3100--
                3199)
     XXXII  National Endowment for the Arts (Parts 3200--3299)
    XXXIII  National Endowment for the Humanities (Parts 3300--
                3399)
     XXXIV  Department of Education (Parts 3400--3499)
      XXXV  Export-Import Bank of the United States (Parts 3500--
                3599)
     XXXVI  Office of National Drug Control Policy, Executive 
                Office of the President (Parts 3600--3699)
    XXXVII  Peace Corps (Parts 3700--3799)
     LVIII  Election Assistance Commission (Parts 5800--5899)
       LIX  Gulf Coast Ecosystem Restoration Council (Parts 5900--
                5999)

                        Title 3--The President

         I  Executive Office of the President (Parts 100--199)

                           Title 4--Accounts

         I  Government Accountability Office (Parts 1--199)

                   Title 5--Administrative Personnel

         I  Office of Personnel Management (Parts 1--1199)
        II  Merit Systems Protection Board (Parts 1200--1299)
       III  Office of Management and Budget (Parts 1300--1399)
        IV  Office of Personnel Management and Office of the 
                Director of National Intelligence (Parts 1400--
                1499)
         V  The International Organizations Employees Loyalty 
                Board (Parts 1500--1599)
        VI  Federal Retirement Thrift Investment Board (Parts 
                1600--1699)
      VIII  Office of Special Counsel (Parts 1800--1899)
        IX  Appalachian Regional Commission (Parts 1900--1999)
        XI  Armed Forces Retirement Home (Parts 2100--2199)
       XIV  Federal Labor Relations Authority, General Counsel of 
                the Federal Labor Relations Authority and Federal 
                Service Impasses Panel (Parts 2400--2499)
       XVI  Office of Government Ethics (Parts 2600--2699)
       XXI  Department of the Treasury (Parts 3100--3199)
      XXII  Federal Deposit Insurance Corporation (Parts 3200--
                3299)
     XXIII  Department of Energy (Parts 3300--3399)
      XXIV  Federal Energy Regulatory Commission (Parts 3400--
                3499)
       XXV  Department of the Interior (Parts 3500--3599)
      XXVI  Department of Defense (Parts 3600--3699)

[[Page 619]]

    XXVIII  Department of Justice (Parts 3800--3899)
      XXIX  Federal Communications Commission (Parts 3900--3999)
       XXX  Farm Credit System Insurance Corporation (Parts 4000--
                4099)
      XXXI  Farm Credit Administration (Parts 4100--4199)
    XXXIII  U.S. International Development Finance Corporation 
                (Parts 4300--4399)
     XXXIV  Securities and Exchange Commission (Parts 4400--4499)
      XXXV  Office of Personnel Management (Parts 4500--4599)
     XXXVI  Department of Homeland Security (Parts 4600--4699)
    XXXVII  Federal Election Commission (Parts 4700--4799)
        XL  Interstate Commerce Commission (Parts 5000--5099)
       XLI  Commodity Futures Trading Commission (Parts 5100--
                5199)
      XLII  Department of Labor (Parts 5200--5299)
     XLIII  National Science Foundation (Parts 5300--5399)
       XLV  Department of Health and Human Services (Parts 5500--
                5599)
      XLVI  Postal Rate Commission (Parts 5600--5699)
     XLVII  Federal Trade Commission (Parts 5700--5799)
    XLVIII  Nuclear Regulatory Commission (Parts 5800--5899)
      XLIX  Federal Labor Relations Authority (Parts 5900--5999)
         L  Department of Transportation (Parts 6000--6099)
       LII  Export-Import Bank of the United States (Parts 6200--
                6299)
      LIII  Department of Education (Parts 6300--6399)
       LIV  Environmental Protection Agency (Parts 6400--6499)
        LV  National Endowment for the Arts (Parts 6500--6599)
       LVI  National Endowment for the Humanities (Parts 6600--
                6699)
      LVII  General Services Administration (Parts 6700--6799)
     LVIII  Board of Governors of the Federal Reserve System 
                (Parts 6800--6899)
       LIX  National Aeronautics and Space Administration (Parts 
                6900--6999)
        LX  United States Postal Service (Parts 7000--7099)
       LXI  National Labor Relations Board (Parts 7100--7199)
      LXII  Equal Employment Opportunity Commission (Parts 7200--
                7299)
     LXIII  Inter-American Foundation (Parts 7300--7399)
      LXIV  Merit Systems Protection Board (Parts 7400--7499)
       LXV  Department of Housing and Urban Development (Parts 
                7500--7599)
      LXVI  National Archives and Records Administration (Parts 
                7600--7699)
     LXVII  Institute of Museum and Library Services (Parts 7700--
                7799)
    LXVIII  Commission on Civil Rights (Parts 7800--7899)
      LXIX  Tennessee Valley Authority (Parts 7900--7999)
       LXX  Court Services and Offender Supervision Agency for the 
                District of Columbia (Parts 8000--8099)
      LXXI  Consumer Product Safety Commission (Parts 8100--8199)
    LXXIII  Department of Agriculture (Parts 8300--8399)

[[Page 620]]

     LXXIV  Federal Mine Safety and Health Review Commission 
                (Parts 8400--8499)
     LXXVI  Federal Retirement Thrift Investment Board (Parts 
                8600--8699)
    LXXVII  Office of Management and Budget (Parts 8700--8799)
      LXXX  Federal Housing Finance Agency (Parts 9000--9099)
   LXXXIII  Special Inspector General for Afghanistan 
                Reconstruction (Parts 9300--9399)
    LXXXIV  Bureau of Consumer Financial Protection (Parts 9400--
                9499)
    LXXXVI  National Credit Union Administration (Parts 9600--
                9699)
     XCVII  Department of Homeland Security Human Resources 
                Management System (Department of Homeland 
                Security--Office of Personnel Management) (Parts 
                9700--9799)
    XCVIII  Council of the Inspectors General on Integrity and 
                Efficiency (Parts 9800--9899)
      XCIX  Military Compensation and Retirement Modernization 
                Commission (Parts 9900--9999)
         C  National Council on Disability (Parts 10000--10049)
        CI  National Mediation Board (Part 10101)

                      Title 6--Domestic Security

         I  Department of Homeland Security, Office of the 
                Secretary (Parts 1--199)
         X  Privacy and Civil Liberties Oversight Board (Parts 
                1000--1099)

                         Title 7--Agriculture

            Subtitle A--Office of the Secretary of Agriculture 
                (Parts 0--26)
            Subtitle B--Regulations of the Department of 
                Agriculture
         I  Agricultural Marketing Service (Standards, 
                Inspections, Marketing Practices), Department of 
                Agriculture (Parts 27--209)
        II  Food and Nutrition Service, Department of Agriculture 
                (Parts 210--299)
       III  Animal and Plant Health Inspection Service, Department 
                of Agriculture (Parts 300--399)
        IV  Federal Crop Insurance Corporation, Department of 
                Agriculture (Parts 400--499)
         V  Agricultural Research Service, Department of 
                Agriculture (Parts 500--599)
        VI  Natural Resources Conservation Service, Department of 
                Agriculture (Parts 600--699)
       VII  Farm Service Agency, Department of Agriculture (Parts 
                700--799)
      VIII  Agricultural Marketing Service (Federal Grain 
                Inspection Service, Fair Trade Practices Program), 
                Department of Agriculture (Parts 800--899)

[[Page 621]]

        IX  Agricultural Marketing Service (Marketing Agreements 
                and Orders; Fruits, Vegetables, Nuts), Department 
                of Agriculture (Parts 900--999)
         X  Agricultural Marketing Service (Marketing Agreements 
                and Orders; Milk), Department of Agriculture 
                (Parts 1000--1199)
        XI  Agricultural Marketing Service (Marketing Agreements 
                and Orders; Miscellaneous Commodities), Department 
                of Agriculture (Parts 1200--1299)
       XIV  Commodity Credit Corporation, Department of 
                Agriculture (Parts 1400--1499)
        XV  Foreign Agricultural Service, Department of 
                Agriculture (Parts 1500--1599)
       XVI  (Parts 1600--1699) [Reserved]
      XVII  Rural Utilities Service, Department of Agriculture 
                (Parts 1700--1799)
     XVIII  Rural Housing Service, Rural Business-Cooperative 
                Service, Rural Utilities Service, and Farm Service 
                Agency, Department of Agriculture (Parts 1800--
                2099)
        XX  (Parts 2200--2299) [Reserved]
       XXV  Office of Advocacy and Outreach, Department of 
                Agriculture (Parts 2500--2599)
      XXVI  Office of Inspector General, Department of Agriculture 
                (Parts 2600--2699)
     XXVII  Office of Information Resources Management, Department 
                of Agriculture (Parts 2700--2799)
    XXVIII  Office of Operations, Department of Agriculture (Parts 
                2800--2899)
      XXIX  Office of Energy Policy and New Uses, Department of 
                Agriculture (Parts 2900--2999)
       XXX  Office of the Chief Financial Officer, Department of 
                Agriculture (Parts 3000--3099)
      XXXI  Office of Environmental Quality, Department of 
                Agriculture (Parts 3100--3199)
     XXXII  Office of Procurement and Property Management, 
                Department of Agriculture (Parts 3200--3299)
    XXXIII  Office of Transportation, Department of Agriculture 
                (Parts 3300--3399)
     XXXIV  National Institute of Food and Agriculture (Parts 
                3400--3499)
      XXXV  Rural Housing Service, Department of Agriculture 
                (Parts 3500--3599)
     XXXVI  National Agricultural Statistics Service, Department 
                of Agriculture (Parts 3600--3699)
    XXXVII  Economic Research Service, Department of Agriculture 
                (Parts 3700--3799)
   XXXVIII  World Agricultural Outlook Board, Department of 
                Agriculture (Parts 3800--3899)
       XLI  [Reserved]
      XLII  Rural Business-Cooperative Service and Rural Utilities 
                Service, Department of Agriculture (Parts 4200--
                4299)

[[Page 622]]

         L  Rural Business-Cooperative Service, Rural Housing 
                Service, and Rural Utilities Service, Department 
                of Agriculture (Part 5001)

                    Title 8--Aliens and Nationality

         I  Department of Homeland Security (Parts 1--499)
         V  Executive Office for Immigration Review, Department of 
                Justice (Parts 1000--1399)

                 Title 9--Animals and Animal Products

         I  Animal and Plant Health Inspection Service, Department 
                of Agriculture (Parts 1--199)
        II  Agricultural Marketing Service (Fair Trade Practices 
                Program), Department of Agriculture (Parts 200--
                299)
       III  Food Safety and Inspection Service, Department of 
                Agriculture (Parts 300--599)

                           Title 10--Energy

         I  Nuclear Regulatory Commission (Parts 0--199)
        II  Department of Energy (Parts 200--699)
       III  Department of Energy (Parts 700--999)
         X  Department of Energy (General Provisions) (Parts 
                1000--1099)
      XIII  Nuclear Waste Technical Review Board (Parts 1300--
                1399)
      XVII  Defense Nuclear Facilities Safety Board (Parts 1700--
                1799)
     XVIII  Northeast Interstate Low-Level Radioactive Waste 
                Commission (Parts 1800--1899)

                      Title 11--Federal Elections

         I  Federal Election Commission (Parts 1--9099)
        II  Election Assistance Commission (Parts 9400--9499)

                      Title 12--Banks and Banking

         I  Comptroller of the Currency, Department of the 
                Treasury (Parts 1--199)
        II  Federal Reserve System (Parts 200--299)
       III  Federal Deposit Insurance Corporation (Parts 300--399)
        IV  Export-Import Bank of the United States (Parts 400--
                499)
         V  (Parts 500--599) [Reserved]
        VI  Farm Credit Administration (Parts 600--699)
       VII  National Credit Union Administration (Parts 700--799)
      VIII  Federal Financing Bank (Parts 800--899)
        IX  (Parts 900--999) [Reserved]
         X  Bureau of Consumer Financial Protection (Parts 1000--
                1099)

[[Page 623]]

        XI  Federal Financial Institutions Examination Council 
                (Parts 1100--1199)
       XII  Federal Housing Finance Agency (Parts 1200--1299)
      XIII  Financial Stability Oversight Council (Parts 1300--
                1399)
       XIV  Farm Credit System Insurance Corporation (Parts 1400--
                1499)
        XV  Department of the Treasury (Parts 1500--1599)
       XVI  Office of Financial Research, Department of the 
                Treasury (Parts 1600--1699)
      XVII  Office of Federal Housing Enterprise Oversight, 
                Department of Housing and Urban Development (Parts 
                1700--1799)
     XVIII  Community Development Financial Institutions Fund, 
                Department of the Treasury (Parts 1800--1899)

               Title 13--Business Credit and Assistance

         I  Small Business Administration (Parts 1--199)
       III  Economic Development Administration, Department of 
                Commerce (Parts 300--399)
        IV  Emergency Steel Guarantee Loan Board (Parts 400--499)
         V  Emergency Oil and Gas Guaranteed Loan Board (Parts 
                500--599)

                    Title 14--Aeronautics and Space

         I  Federal Aviation Administration, Department of 
                Transportation (Parts 1--199)
        II  Office of the Secretary, Department of Transportation 
                (Aviation Proceedings) (Parts 200--399)
       III  Commercial Space Transportation, Federal Aviation 
                Administration, Department of Transportation 
                (Parts 400--1199)
         V  National Aeronautics and Space Administration (Parts 
                1200--1299)
        VI  Air Transportation System Stabilization (Parts 1300--
                1399)

                 Title 15--Commerce and Foreign Trade

            Subtitle A--Office of the Secretary of Commerce (Parts 
                0--29)
            Subtitle B--Regulations Relating to Commerce and 
                Foreign Trade
         I  Bureau of the Census, Department of Commerce (Parts 
                30--199)
        II  National Institute of Standards and Technology, 
                Department of Commerce (Parts 200--299)
       III  International Trade Administration, Department of 
                Commerce (Parts 300--399)
        IV  Foreign-Trade Zones Board, Department of Commerce 
                (Parts 400--499)
       VII  Bureau of Industry and Security, Department of 
                Commerce (Parts 700--799)

[[Page 624]]

      VIII  Bureau of Economic Analysis, Department of Commerce 
                (Parts 800--899)
        IX  National Oceanic and Atmospheric Administration, 
                Department of Commerce (Parts 900--999)
        XI  National Technical Information Service, Department of 
                Commerce (Parts 1100--1199)
      XIII  East-West Foreign Trade Board (Parts 1300--1399)
       XIV  Minority Business Development Agency (Parts 1400--
                1499)
            Subtitle C--Regulations Relating to Foreign Trade 
                Agreements
        XX  Office of the United States Trade Representative 
                (Parts 2000--2099)
            Subtitle D--Regulations Relating to Telecommunications 
                and Information
     XXIII  National Telecommunications and Information 
                Administration, Department of Commerce (Parts 
                2300--2399) [Reserved]

                    Title 16--Commercial Practices

         I  Federal Trade Commission (Parts 0--999)
        II  Consumer Product Safety Commission (Parts 1000--1799)

             Title 17--Commodity and Securities Exchanges

         I  Commodity Futures Trading Commission (Parts 1--199)
        II  Securities and Exchange Commission (Parts 200--399)
        IV  Department of the Treasury (Parts 400--499)

          Title 18--Conservation of Power and Water Resources

         I  Federal Energy Regulatory Commission, Department of 
                Energy (Parts 1--399)
       III  Delaware River Basin Commission (Parts 400--499)
        VI  Water Resources Council (Parts 700--799)
      VIII  Susquehanna River Basin Commission (Parts 800--899)
      XIII  Tennessee Valley Authority (Parts 1300--1399)

                       Title 19--Customs Duties

         I  U.S. Customs and Border Protection, Department of 
                Homeland Security; Department of the Treasury 
                (Parts 0--199)
        II  United States International Trade Commission (Parts 
                200--299)
       III  International Trade Administration, Department of 
                Commerce (Parts 300--399)
        IV  U.S. Immigration and Customs Enforcement, Department 
                of Homeland Security (Parts 400--599) [Reserved]

[[Page 625]]

                     Title 20--Employees' Benefits

         I  Office of Workers' Compensation Programs, Department 
                of Labor (Parts 1--199)
        II  Railroad Retirement Board (Parts 200--399)
       III  Social Security Administration (Parts 400--499)
        IV  Employees' Compensation Appeals Board, Department of 
                Labor (Parts 500--599)
         V  Employment and Training Administration, Department of 
                Labor (Parts 600--699)
        VI  Office of Workers' Compensation Programs, Department 
                of Labor (Parts 700--799)
       VII  Benefits Review Board, Department of Labor (Parts 
                800--899)
      VIII  Joint Board for the Enrollment of Actuaries (Parts 
                900--999)
        IX  Office of the Assistant Secretary for Veterans' 
                Employment and Training Service, Department of 
                Labor (Parts 1000--1099)

                       Title 21--Food and Drugs

         I  Food and Drug Administration, Department of Health and 
                Human Services (Parts 1--1299)
        II  Drug Enforcement Administration, Department of Justice 
                (Parts 1300--1399)
       III  Office of National Drug Control Policy (Parts 1400--
                1499)

                      Title 22--Foreign Relations

         I  Department of State (Parts 1--199)
        II  Agency for International Development (Parts 200--299)
       III  Peace Corps (Parts 300--399)
        IV  International Joint Commission, United States and 
                Canada (Parts 400--499)
         V  United States Agency for Global Media (Parts 500--599)
       VII  U.S. International Development Finance Corporation 
                (Parts 700--799)
        IX  Foreign Service Grievance Board (Parts 900--999)
         X  Inter-American Foundation (Parts 1000--1099)
        XI  International Boundary and Water Commission, United 
                States and Mexico, United States Section (Parts 
                1100--1199)
       XII  United States International Development Cooperation 
                Agency (Parts 1200--1299)
      XIII  Millennium Challenge Corporation (Parts 1300--1399)
       XIV  Foreign Service Labor Relations Board; Federal Labor 
                Relations Authority; General Counsel of the 
                Federal Labor Relations Authority; and the Foreign 
                Service Impasse Disputes Panel (Parts 1400--1499)
        XV  African Development Foundation (Parts 1500--1599)
       XVI  Japan-United States Friendship Commission (Parts 
                1600--1699)
      XVII  United States Institute of Peace (Parts 1700--1799)

[[Page 626]]

                          Title 23--Highways

         I  Federal Highway Administration, Department of 
                Transportation (Parts 1--999)
        II  National Highway Traffic Safety Administration and 
                Federal Highway Administration, Department of 
                Transportation (Parts 1200--1299)
       III  National Highway Traffic Safety Administration, 
                Department of Transportation (Parts 1300--1399)

                Title 24--Housing and Urban Development

            Subtitle A--Office of the Secretary, Department of 
                Housing and Urban Development (Parts 0--99)
            Subtitle B--Regulations Relating to Housing and Urban 
                Development
         I  Office of Assistant Secretary for Equal Opportunity, 
                Department of Housing and Urban Development (Parts 
                100--199)
        II  Office of Assistant Secretary for Housing-Federal 
                Housing Commissioner, Department of Housing and 
                Urban Development (Parts 200--299)
       III  Government National Mortgage Association, Department 
                of Housing and Urban Development (Parts 300--399)
        IV  Office of Housing and Office of Multifamily Housing 
                Assistance Restructuring, Department of Housing 
                and Urban Development (Parts 400--499)
         V  Office of Assistant Secretary for Community Planning 
                and Development, Department of Housing and Urban 
                Development (Parts 500--599)
        VI  Office of Assistant Secretary for Community Planning 
                and Development, Department of Housing and Urban 
                Development (Parts 600--699) [Reserved]
       VII  Office of the Secretary, Department of Housing and 
                Urban Development (Housing Assistance Programs and 
                Public and Indian Housing Programs) (Parts 700--
                799)
      VIII  Office of the Assistant Secretary for Housing--Federal 
                Housing Commissioner, Department of Housing and 
                Urban Development (Section 8 Housing Assistance 
                Programs, Section 202 Direct Loan Program, Section 
                202 Supportive Housing for the Elderly Program and 
                Section 811 Supportive Housing for Persons With 
                Disabilities Program) (Parts 800--899)
        IX  Office of Assistant Secretary for Public and Indian 
                Housing, Department of Housing and Urban 
                Development (Parts 900--1699)
         X  Office of Assistant Secretary for Housing--Federal 
                Housing Commissioner, Department of Housing and 
                Urban Development (Interstate Land Sales 
                Registration Program) [Reserved]
       XII  Office of Inspector General, Department of Housing and 
                Urban Development (Parts 2000--2099)
        XV  Emergency Mortgage Insurance and Loan Programs, 
                Department of Housing and Urban Development (Parts 
                2700--2799) [Reserved]
        XX  Office of Assistant Secretary for Housing--Federal 
                Housing Commissioner, Department of Housing and 
                Urban Development (Parts 3200--3899)

[[Page 627]]

      XXIV  Board of Directors of the HOPE for Homeowners Program 
                (Parts 4000--4099) [Reserved]
       XXV  Neighborhood Reinvestment Corporation (Parts 4100--
                4199)

                           Title 25--Indians

         I  Bureau of Indian Affairs, Department of the Interior 
                (Parts 1--299)
        II  Indian Arts and Crafts Board, Department of the 
                Interior (Parts 300--399)
       III  National Indian Gaming Commission, Department of the 
                Interior (Parts 500--599)
        IV  Office of Navajo and Hopi Indian Relocation (Parts 
                700--899)
         V  Bureau of Indian Affairs, Department of the Interior, 
                and Indian Health Service, Department of Health 
                and Human Services (Part 900--999)
        VI  Office of the Assistant Secretary, Indian Affairs, 
                Department of the Interior (Parts 1000--1199)
       VII  Office of the Special Trustee for American Indians, 
                Department of the Interior (Parts 1200--1299)

                      Title 26--Internal Revenue

         I  Internal Revenue Service, Department of the Treasury 
                (Parts 1--End)

           Title 27--Alcohol, Tobacco Products and Firearms

         I  Alcohol and Tobacco Tax and Trade Bureau, Department 
                of the Treasury (Parts 1--399)
        II  Bureau of Alcohol, Tobacco, Firearms, and Explosives, 
                Department of Justice (Parts 400--799)

                   Title 28--Judicial Administration

         I  Department of Justice (Parts 0--299)
       III  Federal Prison Industries, Inc., Department of Justice 
                (Parts 300--399)
         V  Bureau of Prisons, Department of Justice (Parts 500--
                599)
        VI  Offices of Independent Counsel, Department of Justice 
                (Parts 600--699)
       VII  Office of Independent Counsel (Parts 700--799)
      VIII  Court Services and Offender Supervision Agency for the 
                District of Columbia (Parts 800--899)
        IX  National Crime Prevention and Privacy Compact Council 
                (Parts 900--999)
        XI  Department of Justice and Department of State (Parts 
                1100--1199)

[[Page 628]]

                            Title 29--Labor

            Subtitle A--Office of the Secretary of Labor (Parts 
                0--99)
            Subtitle B--Regulations Relating to Labor
         I  National Labor Relations Board (Parts 100--199)
        II  Office of Labor-Management Standards, Department of 
                Labor (Parts 200--299)
       III  National Railroad Adjustment Board (Parts 300--399)
        IV  Office of Labor-Management Standards, Department of 
                Labor (Parts 400--499)
         V  Wage and Hour Division, Department of Labor (Parts 
                500--899)
        IX  Construction Industry Collective Bargaining Commission 
                (Parts 900--999)
         X  National Mediation Board (Parts 1200--1299)
       XII  Federal Mediation and Conciliation Service (Parts 
                1400--1499)
       XIV  Equal Employment Opportunity Commission (Parts 1600--
                1699)
      XVII  Occupational Safety and Health Administration, 
                Department of Labor (Parts 1900--1999)
        XX  Occupational Safety and Health Review Commission 
                (Parts 2200--2499)
       XXV  Employee Benefits Security Administration, Department 
                of Labor (Parts 2500--2599)
     XXVII  Federal Mine Safety and Health Review Commission 
                (Parts 2700--2799)
        XL  Pension Benefit Guaranty Corporation (Parts 4000--
                4999)

                      Title 30--Mineral Resources

         I  Mine Safety and Health Administration, Department of 
                Labor (Parts 1--199)
        II  Bureau of Safety and Environmental Enforcement, 
                Department of the Interior (Parts 200--299)
        IV  Geological Survey, Department of the Interior (Parts 
                400--499)
         V  Bureau of Ocean Energy Management, Department of the 
                Interior (Parts 500--599)
       VII  Office of Surface Mining Reclamation and Enforcement, 
                Department of the Interior (Parts 700--999)
       XII  Office of Natural Resources Revenue, Department of the 
                Interior (Parts 1200--1299)

                 Title 31--Money and Finance: Treasury

            Subtitle A--Office of the Secretary of the Treasury 
                (Parts 0--50)
            Subtitle B--Regulations Relating to Money and Finance
         I  Monetary Offices, Department of the Treasury (Parts 
                51--199)
        II  Fiscal Service, Department of the Treasury (Parts 
                200--399)
        IV  Secret Service, Department of the Treasury (Parts 
                400--499)
         V  Office of Foreign Assets Control, Department of the 
                Treasury (Parts 500--599)

[[Page 629]]

        VI  Bureau of Engraving and Printing, Department of the 
                Treasury (Parts 600--699)
       VII  Federal Law Enforcement Training Center, Department of 
                the Treasury (Parts 700--799)
      VIII  Office of Investment Security, Department of the 
                Treasury (Parts 800--899)
        IX  Federal Claims Collection Standards (Department of the 
                Treasury--Department of Justice) (Parts 900--999)
         X  Financial Crimes Enforcement Network, Department of 
                the Treasury (Parts 1000--1099)

                      Title 32--National Defense

            Subtitle A--Department of Defense
         I  Office of the Secretary of Defense (Parts 1--399)
         V  Department of the Army (Parts 400--699)
        VI  Department of the Navy (Parts 700--799)
       VII  Department of the Air Force (Parts 800--1099)
            Subtitle B--Other Regulations Relating to National 
                Defense
       XII  Department of Defense, Defense Logistics Agency (Parts 
                1200--1299)
       XVI  Selective Service System (Parts 1600--1699)
      XVII  Office of the Director of National Intelligence (Parts 
                1700--1799)
     XVIII  National Counterintelligence Center (Parts 1800--1899)
       XIX  Central Intelligence Agency (Parts 1900--1999)
        XX  Information Security Oversight Office, National 
                Archives and Records Administration (Parts 2000--
                2099)
       XXI  National Security Council (Parts 2100--2199)
      XXIV  Office of Science and Technology Policy (Parts 2400--
                2499)
     XXVII  Office for Micronesian Status Negotiations (Parts 
                2700--2799)
    XXVIII  Office of the Vice President of the United States 
                (Parts 2800--2899)

               Title 33--Navigation and Navigable Waters

         I  Coast Guard, Department of Homeland Security (Parts 
                1--199)
        II  Corps of Engineers, Department of the Army, Department 
                of Defense (Parts 200--399)
        IV  Great Lakes St. Lawrence Seaway Development 
                Corporation, Department of Transportation (Parts 
                400--499)

                          Title 34--Education

            Subtitle A--Office of the Secretary, Department of 
                Education (Parts 1--99)
            Subtitle B--Regulations of the Offices of the 
                Department of Education

[[Page 630]]

         I  Office for Civil Rights, Department of Education 
                (Parts 100--199)
        II  Office of Elementary and Secondary Education, 
                Department of Education (Parts 200--299)
       III  Office of Special Education and Rehabilitative 
                Services, Department of Education (Parts 300--399)
        IV  Office of Career, Technical, and Adult Education, 
                Department of Education (Parts 400--499)
         V  Office of Bilingual Education and Minority Languages 
                Affairs, Department of Education (Parts 500--599) 
                [Reserved]
        VI  Office of Postsecondary Education, Department of 
                Education (Parts 600--699)
       VII  Office of Educational Research and Improvement, 
                Department of Education (Parts 700--799) 
                [Reserved]
            Subtitle C--Regulations Relating to Education
        XI  (Parts 1100--1199) [Reserved]
       XII  National Council on Disability (Parts 1200--1299)

                          Title 35 [Reserved]

             Title 36--Parks, Forests, and Public Property

         I  National Park Service, Department of the Interior 
                (Parts 1--199)
        II  Forest Service, Department of Agriculture (Parts 200--
                299)
       III  Corps of Engineers, Department of the Army (Parts 
                300--399)
        IV  American Battle Monuments Commission (Parts 400--499)
         V  Smithsonian Institution (Parts 500--599)
        VI  [Reserved]
       VII  Library of Congress (Parts 700--799)
      VIII  Advisory Council on Historic Preservation (Parts 800--
                899)
        IX  Pennsylvania Avenue Development Corporation (Parts 
                900--999)
         X  Presidio Trust (Parts 1000--1099)
        XI  Architectural and Transportation Barriers Compliance 
                Board (Parts 1100--1199)
       XII  National Archives and Records Administration (Parts 
                1200--1299)
        XV  Oklahoma City National Memorial Trust (Parts 1500--
                1599)
       XVI  Morris K. Udall Scholarship and Excellence in National 
                Environmental Policy Foundation (Parts 1600--1699)

             Title 37--Patents, Trademarks, and Copyrights

         I  United States Patent and Trademark Office, Department 
                of Commerce (Parts 1--199)
        II  U.S. Copyright Office, Library of Congress (Parts 
                200--299)
       III  Copyright Royalty Board, Library of Congress (Parts 
                300--399)
        IV  National Institute of Standards and Technology, 
                Department of Commerce (Parts 400--599)

[[Page 631]]

           Title 38--Pensions, Bonuses, and Veterans' Relief

         I  Department of Veterans Affairs (Parts 0--199)
        II  Armed Forces Retirement Home (Parts 200--299)

                       Title 39--Postal Service

         I  United States Postal Service (Parts 1--999)
       III  Postal Regulatory Commission (Parts 3000--3099)

                  Title 40--Protection of Environment

         I  Environmental Protection Agency (Parts 1--1099)
        IV  Environmental Protection Agency and Department of 
                Justice (Parts 1400--1499)
         V  Council on Environmental Quality (Parts 1500--1599)
        VI  Chemical Safety and Hazard Investigation Board (Parts 
                1600--1699)
       VII  Environmental Protection Agency and Department of 
                Defense; Uniform National Discharge Standards for 
                Vessels of the Armed Forces (Parts 1700--1799)
      VIII  Gulf Coast Ecosystem Restoration Council (Parts 1800--
                1899)
        IX  Federal Permitting Improvement Steering Council (Part 
                1900)

          Title 41--Public Contracts and Property Management

            Subtitle A--Federal Procurement Regulations System 
                [Note]
            Subtitle B--Other Provisions Relating to Public 
                Contracts
        50  Public Contracts, Department of Labor (Parts 50-1--50-
                999)
        51  Committee for Purchase From People Who Are Blind or 
                Severely Disabled (Parts 51-1--51-99)
        60  Office of Federal Contract Compliance Programs, Equal 
                Employment Opportunity, Department of Labor (Parts 
                60-1--60-999)
        61  Office of the Assistant Secretary for Veterans' 
                Employment and Training Service, Department of 
                Labor (Parts 61-1--61-999)
   62--100  [Reserved]
            Subtitle C--Federal Property Management Regulations 
                System
       101  Federal Property Management Regulations (Parts 101-1--
                101-99)
       102  Federal Management Regulation (Parts 102-1--102-299)
  103--104  (Parts 103-001--104-099) [Reserved]
       105  General Services Administration (Parts 105-1--105-999)
       109  Department of Energy Property Management Regulations 
                (Parts 109-1--109-99)
       114  Department of the Interior (Parts 114-1--114-99)
       115  Environmental Protection Agency (Parts 115-1--115-99)
       128  Department of Justice (Parts 128-1--128-99)
  129--200  [Reserved]

[[Page 632]]

            Subtitle D--Other Provisions Relating to Property 
                Management [Reserved]
            Subtitle E--Federal Information Resources Management 
                Regulations System [Reserved]
            Subtitle F--Federal Travel Regulation System
       300  General (Parts 300-1--300-99)
       301  Temporary Duty (TDY) Travel Allowances (Parts 301-1--
                301-99)
       302  Relocation Allowances (Parts 302-1--302-99)
       303  Payment of Expenses Connected with the Death of 
                Certain Employees (Part 303-1--303-99)
       304  Payment of Travel Expenses from a Non-Federal Source 
                (Parts 304-1--304-99)

                        Title 42--Public Health

         I  Public Health Service, Department of Health and Human 
                Services (Parts 1--199)
   II--III  [Reserved]
        IV  Centers for Medicare & Medicaid Services, Department 
                of Health and Human Services (Parts 400--699)
         V  Office of Inspector General-Health Care, Department of 
                Health and Human Services (Parts 1000--1099)

                   Title 43--Public Lands: Interior

            Subtitle A--Office of the Secretary of the Interior 
                (Parts 1--199)
            Subtitle B--Regulations Relating to Public Lands
         I  Bureau of Reclamation, Department of the Interior 
                (Parts 400--999)
        II  Bureau of Land Management, Department of the Interior 
                (Parts 1000--9999)
       III  Utah Reclamation Mitigation and Conservation 
                Commission (Parts 10000--10099)

             Title 44--Emergency Management and Assistance

         I  Federal Emergency Management Agency, Department of 
                Homeland Security (Parts 0--399)
        IV  Department of Commerce and Department of 
                Transportation (Parts 400--499)

                       Title 45--Public Welfare

            Subtitle A--Department of Health and Human Services 
                (Parts 1--199)
            Subtitle B--Regulations Relating to Public Welfare

[[Page 633]]

        II  Office of Family Assistance (Assistance Programs), 
                Administration for Children and Families, 
                Department of Health and Human Services (Parts 
                200--299)
       III  Office of Child Support Enforcement (Child Support 
                Enforcement Program), Administration for Children 
                and Families, Department of Health and Human 
                Services (Parts 300--399)
        IV  Office of Refugee Resettlement, Administration for 
                Children and Families, Department of Health and 
                Human Services (Parts 400--499)
         V  Foreign Claims Settlement Commission of the United 
                States, Department of Justice (Parts 500--599)
        VI  National Science Foundation (Parts 600--699)
       VII  Commission on Civil Rights (Parts 700--799)
      VIII  Office of Personnel Management (Parts 800--899)
        IX  Denali Commission (Parts 900--999)
         X  Office of Community Services, Administration for 
                Children and Families, Department of Health and 
                Human Services (Parts 1000--1099)
        XI  National Foundation on the Arts and the Humanities 
                (Parts 1100--1199)
       XII  Corporation for National and Community Service (Parts 
                1200--1299)
      XIII  Administration for Children and Families, Department 
                of Health and Human Services (Parts 1300--1399)
       XVI  Legal Services Corporation (Parts 1600--1699)
      XVII  National Commission on Libraries and Information 
                Science (Parts 1700--1799)
     XVIII  Harry S. Truman Scholarship Foundation (Parts 1800--
                1899)
       XXI  Commission of Fine Arts (Parts 2100--2199)
     XXIII  Arctic Research Commission (Parts 2300--2399)
      XXIV  James Madison Memorial Fellowship Foundation (Parts 
                2400--2499)
       XXV  Corporation for National and Community Service (Parts 
                2500--2599)

                          Title 46--Shipping

         I  Coast Guard, Department of Homeland Security (Parts 
                1--199)
        II  Maritime Administration, Department of Transportation 
                (Parts 200--399)
       III  Coast Guard (Great Lakes Pilotage), Department of 
                Homeland Security (Parts 400--499)
        IV  Federal Maritime Commission (Parts 500--599)

                      Title 47--Telecommunication

         I  Federal Communications Commission (Parts 0--199)
        II  Office of Science and Technology Policy and National 
                Security Council (Parts 200--299)

[[Page 634]]

       III  National Telecommunications and Information 
                Administration, Department of Commerce (Parts 
                300--399)
        IV  National Telecommunications and Information 
                Administration, Department of Commerce, and 
                National Highway Traffic Safety Administration, 
                Department of Transportation (Parts 400--499)
         V  The First Responder Network Authority (Parts 500--599)

           Title 48--Federal Acquisition Regulations System

         1  Federal Acquisition Regulation (Parts 1--99)
         2  Defense Acquisition Regulations System, Department of 
                Defense (Parts 200--299)
         3  Department of Health and Human Services (Parts 300--
                399)
         4  Department of Agriculture (Parts 400--499)
         5  General Services Administration (Parts 500--599)
         6  Department of State (Parts 600--699)
         7  Agency for International Development (Parts 700--799)
         8  Department of Veterans Affairs (Parts 800--899)
         9  Department of Energy (Parts 900--999)
        10  Department of the Treasury (Parts 1000--1099)
        12  Department of Transportation (Parts 1200--1299)
        13  Department of Commerce (Parts 1300--1399)
        14  Department of the Interior (Parts 1400--1499)
        15  Environmental Protection Agency (Parts 1500--1599)
        16  Office of Personnel Management Federal Employees 
                Health Benefits Acquisition Regulation (Parts 
                1600--1699)
        17  Office of Personnel Management (Parts 1700--1799)
        18  National Aeronautics and Space Administration (Parts 
                1800--1899)
        19  Broadcasting Board of Governors (Parts 1900--1999)
        20  Nuclear Regulatory Commission (Parts 2000--2099)
        21  Office of Personnel Management, Federal Employees 
                Group Life Insurance Federal Acquisition 
                Regulation (Parts 2100--2199)
        23  Social Security Administration (Parts 2300--2399)
        24  Department of Housing and Urban Development (Parts 
                2400--2499)
        25  National Science Foundation (Parts 2500--2599)
        28  Department of Justice (Parts 2800--2899)
        29  Department of Labor (Parts 2900--2999)
        30  Department of Homeland Security, Homeland Security 
                Acquisition Regulation (HSAR) (Parts 3000--3099)
        34  Department of Education Acquisition Regulation (Parts 
                3400--3499)
        51  Department of the Army Acquisition Regulations (Parts 
                5100--5199) [Reserved]
        52  Department of the Navy Acquisition Regulations (Parts 
                5200--5299)

[[Page 635]]

        53  Department of the Air Force Federal Acquisition 
                Regulation Supplement (Parts 5300--5399) 
                [Reserved]
        54  Defense Logistics Agency, Department of Defense (Parts 
                5400--5499)
        57  African Development Foundation (Parts 5700--5799)
        61  Civilian Board of Contract Appeals, General Services 
                Administration (Parts 6100--6199)
        99  Cost Accounting Standards Board, Office of Federal 
                Procurement Policy, Office of Management and 
                Budget (Parts 9900--9999)

                       Title 49--Transportation

            Subtitle A--Office of the Secretary of Transportation 
                (Parts 1--99)
            Subtitle B--Other Regulations Relating to 
                Transportation
         I  Pipeline and Hazardous Materials Safety 
                Administration, Department of Transportation 
                (Parts 100--199)
        II  Federal Railroad Administration, Department of 
                Transportation (Parts 200--299)
       III  Federal Motor Carrier Safety Administration, 
                Department of Transportation (Parts 300--399)
        IV  Coast Guard, Department of Homeland Security (Parts 
                400--499)
         V  National Highway Traffic Safety Administration, 
                Department of Transportation (Parts 500--599)
        VI  Federal Transit Administration, Department of 
                Transportation (Parts 600--699)
       VII  National Railroad Passenger Corporation (AMTRAK) 
                (Parts 700--799)
      VIII  National Transportation Safety Board (Parts 800--999)
         X  Surface Transportation Board (Parts 1000--1399)
        XI  Research and Innovative Technology Administration, 
                Department of Transportation (Parts 1400--1499) 
                [Reserved]
       XII  Transportation Security Administration, Department of 
                Homeland Security (Parts 1500--1699)

                   Title 50--Wildlife and Fisheries

         I  United States Fish and Wildlife Service, Department of 
                the Interior (Parts 1--199)
        II  National Marine Fisheries Service, National Oceanic 
                and Atmospheric Administration, Department of 
                Commerce (Parts 200--299)
       III  International Fishing and Related Activities (Parts 
                300--399)
        IV  Joint Regulations (United States Fish and Wildlife 
                Service, Department of the Interior and National 
                Marine Fisheries Service, National Oceanic and 
                Atmospheric Administration, Department of 
                Commerce); Endangered Species Committee 
                Regulations (Parts 400--499)
         V  Marine Mammal Commission (Parts 500--599)

[[Page 636]]

        VI  Fishery Conservation and Management, National Oceanic 
                and Atmospheric Administration, Department of 
                Commerce (Parts 600--699)

[[Page 637]]





           Alphabetical List of Agencies Appearing in the CFR




                      (Revised as of April 1, 2021)

                                                  CFR Title, Subtitle or 
                     Agency                               Chapter

Administrative Conference of the United States    1, III
Advisory Council on Historic Preservation         36, VIII
Advocacy and Outreach, Office of                  7, XXV
Afghanistan Reconstruction, Special Inspector     5, LXXXIII
     General for
African Development Foundation                    22, XV
  Federal Acquisition Regulation                  48, 57
Agency for International Development              2, VII; 22, II
  Federal Acquisition Regulation                  48, 7
Agricultural Marketing Service                    7, I, VIII, IX, X, XI; 9, 
                                                  II
Agricultural Research Service                     7, V
Agriculture, Department of                        2, IV; 5, LXXIII
  Advocacy and Outreach, Office of                7, XXV
  Agricultural Marketing Service                  7, I, VIII, IX, X, XI; 9, 
                                                  II
  Agricultural Research Service                   7, V
  Animal and Plant Health Inspection Service      7, III; 9, I
  Chief Financial Officer, Office of              7, XXX
  Commodity Credit Corporation                    7, XIV
  Economic Research Service                       7, XXXVII
  Energy Policy and New Uses, Office of           2, IX; 7, XXIX
  Environmental Quality, Office of                7, XXXI
  Farm Service Agency                             7, VII, XVIII
  Federal Acquisition Regulation                  48, 4
  Federal Crop Insurance Corporation              7, IV
  Food and Nutrition Service                      7, II
  Food Safety and Inspection Service              9, III
  Foreign Agricultural Service                    7, XV
  Forest Service                                  36, II
  Information Resources Management, Office of     7, XXVII
  Inspector General, Office of                    7, XXVI
  National Agricultural Library                   7, XLI
  National Agricultural Statistics Service        7, XXXVI
  National Institute of Food and Agriculture      7, XXXIV
  Natural Resources Conservation Service          7, VI
  Operations, Office of                           7, XXVIII
  Procurement and Property Management, Office of  7, XXXII
  Rural Business-Cooperative Service              7, XVIII, XLII
  Rural Development Administration                7, XLII
  Rural Housing Service                           7, XVIII, XXXV
  Rural Utilities Service                         7, XVII, XVIII, XLII
  Secretary of Agriculture, Office of             7, Subtitle A
  Transportation, Office of                       7, XXXIII
  World Agricultural Outlook Board                7, XXXVIII
Air Force, Department of                          32, VII
  Federal Acquisition Regulation Supplement       48, 53
Air Transportation Stabilization Board            14, VI
Alcohol and Tobacco Tax and Trade Bureau          27, I
Alcohol, Tobacco, Firearms, and Explosives,       27, II
     Bureau of
AMTRAK                                            49, VII
American Battle Monuments Commission              36, IV
American Indians, Office of the Special Trustee   25, VII
Animal and Plant Health Inspection Service        7, III; 9, I
Appalachian Regional Commission                   5, IX
Architectural and Transportation Barriers         36, XI
   Compliance Board
[[Page 638]]

Arctic Research Commission                        45, XXIII
Armed Forces Retirement Home                      5, XI; 38, II
Army, Department of                               32, V
  Engineers, Corps of                             33, II; 36, III
  Federal Acquisition Regulation                  48, 51
Benefits Review Board                             20, VII
Bilingual Education and Minority Languages        34, V
     Affairs, Office of
Blind or Severely Disabled, Committee for         41, 51
     Purchase from People Who Are
  Federal Acquisition Regulation                  48, 19
Career, Technical, and Adult Education, Office    34, IV
     of
Census Bureau                                     15, I
Centers for Medicare & Medicaid Services          42, IV
Central Intelligence Agency                       32, XIX
Chemical Safety and Hazard Investigation Board    40, VI
Chief Financial Officer, Office of                7, XXX
Child Support Enforcement, Office of              45, III
Children and Families, Administration for         45, II, III, IV, X, XIII
Civil Rights, Commission on                       5, LXVIII; 45, VII
Civil Rights, Office for                          34, I
Coast Guard                                       33, I; 46, I; 49, IV
Coast Guard (Great Lakes Pilotage)                46, III
Commerce, Department of                           2, XIII; 44, IV; 50, VI
  Census Bureau                                   15, I
  Economic Analysis, Bureau of                    15, VIII
  Economic Development Administration             13, III
  Emergency Management and Assistance             44, IV
  Federal Acquisition Regulation                  48, 13
  Foreign-Trade Zones Board                       15, IV
  Industry and Security, Bureau of                15, VII
  International Trade Administration              15, III; 19, III
  National Institute of Standards and Technology  15, II; 37, IV
  National Marine Fisheries Service               50, II, IV
  National Oceanic and Atmospheric                15, IX; 50, II, III, IV, 
       Administration                             VI
  National Technical Information Service          15, XI
  National Telecommunications and Information     15, XXIII; 47, III, IV
       Administration
  National Weather Service                        15, IX
  Patent and Trademark Office, United States      37, I
  Secretary of Commerce, Office of                15, Subtitle A
Commercial Space Transportation                   14, III
Commodity Credit Corporation                      7, XIV
Commodity Futures Trading Commission              5, XLI; 17, I
Community Planning and Development, Office of     24, V, VI
     Assistant Secretary for
Community Services, Office of                     45, X
Comptroller of the Currency                       12, I
Construction Industry Collective Bargaining       29, IX
     Commission
Consumer Financial Protection Bureau              5, LXXXIV; 12, X
Consumer Product Safety Commission                5, LXXI; 16, II
Copyright Royalty Board                           37, III
Corporation for National and Community Service    2, XXII; 45, XII, XXV
Cost Accounting Standards Board                   48, 99
Council on Environmental Quality                  40, V
Council of the Inspectors General on Integrity    5, XCVIII
     and Efficiency
Court Services and Offender Supervision Agency    5, LXX; 28, VIII
     for the District of Columbia
Customs and Border Protection                     19, I
Defense, Department of                            2, XI; 5, XXVI; 32, 
                                                  Subtitle A; 40, VII
  Advanced Research Projects Agency               32, I
  Air Force Department                            32, VII
  Army Department                                 32, V; 33, II; 36, III; 
                                                  48, 51
  Defense Acquisition Regulations System          48, 2
  Defense Intelligence Agency                     32, I
  Defense Logistics Agency                        32, I, XII; 48, 54

[[Page 639]]

  Engineers, Corps of                             33, II; 36, III
  National Imagery and Mapping Agency             32, I
  Navy, Department of                             32, VI; 48, 52
  Secretary of Defense, Office of                 2, XI; 32, I
Defense Contract Audit Agency                     32, I
Defense Intelligence Agency                       32, I
Defense Logistics Agency                          32, XII; 48, 54
Defense Nuclear Facilities Safety Board           10, XVII
Delaware River Basin Commission                   18, III
Denali Commission                                 45, IX
Disability, National Council on                   5, C; 34, XII
District of Columbia, Court Services and          5, LXX; 28, VIII
     Offender Supervision Agency for the
Drug Enforcement Administration                   21, II
East-West Foreign Trade Board                     15, XIII
Economic Analysis, Bureau of                      15, VIII
Economic Development Administration               13, III
Economic Research Service                         7, XXXVII
Education, Department of                          2, XXXIV; 5, LIII
  Bilingual Education and Minority Languages      34, V
       Affairs, Office of
  Career, Technical, and Adult Education, Office  34, IV
       of
  Civil Rights, Office for                        34, I
  Educational Research and Improvement, Office    34, VII
       of
  Elementary and Secondary Education, Office of   34, II
  Federal Acquisition Regulation                  48, 34
  Postsecondary Education, Office of              34, VI
  Secretary of Education, Office of               34, Subtitle A
  Special Education and Rehabilitative Services,  34, III
       Office of
Educational Research and Improvement, Office of   34, VII
Election Assistance Commission                    2, LVIII; 11, II
Elementary and Secondary Education, Office of     34, II
Emergency Oil and Gas Guaranteed Loan Board       13, V
Emergency Steel Guarantee Loan Board              13, IV
Employee Benefits Security Administration         29, XXV
Employees' Compensation Appeals Board             20, IV
Employees Loyalty Board                           5, V
Employment and Training Administration            20, V
Employment Policy, National Commission for        1, IV
Employment Standards Administration               20, VI
Endangered Species Committee                      50, IV
Energy, Department of                             2, IX; 5, XXIII; 10, II, 
                                                  III, X
  Federal Acquisition Regulation                  48, 9
  Federal Energy Regulatory Commission            5, XXIV; 18, I
  Property Management Regulations                 41, 109
Energy, Office of                                 7, XXIX
Engineers, Corps of                               33, II; 36, III
Engraving and Printing, Bureau of                 31, VI
Environmental Protection Agency                   2, XV; 5, LIV; 40, I, IV, 
                                                  VII
  Federal Acquisition Regulation                  48, 15
  Property Management Regulations                 41, 115
Environmental Quality, Office of                  7, XXXI
Equal Employment Opportunity Commission           5, LXII; 29, XIV
Equal Opportunity, Office of Assistant Secretary  24, I
     for
Executive Office of the President                 3, I
  Environmental Quality, Council on               40, V
  Management and Budget, Office of                2, Subtitle A; 5, III, 
                                                  LXXVII; 14, VI; 48, 99
  National Drug Control Policy, Office of         2, XXXVI; 21, III
  National Security Council                       32, XXI; 47, II
  Presidential Documents                          3
  Science and Technology Policy, Office of        32, XXIV; 47, II
  Trade Representative, Office of the United      15, XX
       States
Export-Import Bank of the United States           2, XXXV; 5, LII; 12, IV
Family Assistance, Office of                      45, II

[[Page 640]]

Farm Credit Administration                        5, XXXI; 12, VI
Farm Credit System Insurance Corporation          5, XXX; 12, XIV
Farm Service Agency                               7, VII, XVIII
Federal Acquisition Regulation                    48, 1
Federal Aviation Administration                   14, I
  Commercial Space Transportation                 14, III
Federal Claims Collection Standards               31, IX
Federal Communications Commission                 5, XXIX; 47, I
Federal Contract Compliance Programs, Office of   41, 60
Federal Crop Insurance Corporation                7, IV
Federal Deposit Insurance Corporation             5, XXII; 12, III
Federal Election Commission                       5, XXXVII; 11, I
Federal Emergency Management Agency               44, I
Federal Employees Group Life Insurance Federal    48, 21
     Acquisition Regulation
Federal Employees Health Benefits Acquisition     48, 16
     Regulation
Federal Energy Regulatory Commission              5, XXIV; 18, I
Federal Financial Institutions Examination        12, XI
     Council
Federal Financing Bank                            12, VIII
Federal Highway Administration                    23, I, II
Federal Home Loan Mortgage Corporation            1, IV
Federal Housing Enterprise Oversight Office       12, XVII
Federal Housing Finance Agency                    5, LXXX; 12, XII
Federal Labor Relations Authority                 5, XIV, XLIX; 22, XIV
Federal Law Enforcement Training Center           31, VII
Federal Management Regulation                     41, 102
Federal Maritime Commission                       46, IV
Federal Mediation and Conciliation Service        29, XII
Federal Mine Safety and Health Review Commission  5, LXXIV; 29, XXVII
Federal Motor Carrier Safety Administration       49, III
Federal Permitting Improvement Steering Council   40, IX
Federal Prison Industries, Inc.                   28, III
Federal Procurement Policy Office                 48, 99
Federal Property Management Regulations           41, 101
Federal Railroad Administration                   49, II
Federal Register, Administrative Committee of     1, I
Federal Register, Office of                       1, II
Federal Reserve System                            12, II
  Board of Governors                              5, LVIII
Federal Retirement Thrift Investment Board        5, VI, LXXVI
Federal Service Impasses Panel                    5, XIV
Federal Trade Commission                          5, XLVII; 16, I
Federal Transit Administration                    49, VI
Federal Travel Regulation System                  41, Subtitle F
Financial Crimes Enforcement Network              31, X
Financial Research Office                         12, XVI
Financial Stability Oversight Council             12, XIII
Fine Arts, Commission of                          45, XXI
Fiscal Service                                    31, II
Fish and Wildlife Service, United States          50, I, IV
Food and Drug Administration                      21, I
Food and Nutrition Service                        7, II
Food Safety and Inspection Service                9, III
Foreign Agricultural Service                      7, XV
Foreign Assets Control, Office of                 31, V
Foreign Claims Settlement Commission of the       45, V
     United States
Foreign Service Grievance Board                   22, IX
Foreign Service Impasse Disputes Panel            22, XIV
Foreign Service Labor Relations Board             22, XIV
Foreign-Trade Zones Board                         15, IV
Forest Service                                    36, II
General Services Administration                   5, LVII; 41, 105
  Contract Appeals, Board of                      48, 61
  Federal Acquisition Regulation                  48, 5
  Federal Management Regulation                   41, 102
  Federal Property Management Regulations         41, 101
  Federal Travel Regulation System                41, Subtitle F

[[Page 641]]

  General                                         41, 300
  Payment From a Non-Federal Source for Travel    41, 304
       Expenses
  Payment of Expenses Connected With the Death    41, 303
       of Certain Employees
  Relocation Allowances                           41, 302
  Temporary Duty (TDY) Travel Allowances          41, 301
Geological Survey                                 30, IV
Government Accountability Office                  4, I
Government Ethics, Office of                      5, XVI
Government National Mortgage Association          24, III
Grain Inspection, Packers and Stockyards          7, VIII; 9, II
     Administration
Gulf Coast Ecosystem Restoration Council          2, LIX; 40, VIII
Harry S. Truman Scholarship Foundation            45, XVIII
Health and Human Services, Department of          2, III; 5, XLV; 45, 
                                                  Subtitle A
  Centers for Medicare & Medicaid Services        42, IV
  Child Support Enforcement, Office of            45, III
  Children and Families, Administration for       45, II, III, IV, X, XIII
  Community Services, Office of                   45, X
  Family Assistance, Office of                    45, II
  Federal Acquisition Regulation                  48, 3
  Food and Drug Administration                    21, I
  Indian Health Service                           25, V
  Inspector General (Health Care), Office of      42, V
  Public Health Service                           42, I
  Refugee Resettlement, Office of                 45, IV
Homeland Security, Department of                  2, XXX; 5, XXXVI; 6, I; 8, 
                                                  I
  Coast Guard                                     33, I; 46, I; 49, IV
  Coast Guard (Great Lakes Pilotage)              46, III
  Customs and Border Protection                   19, I
  Federal Emergency Management Agency             44, I
  Human Resources Management and Labor Relations  5, XCVII
       Systems
  Immigration and Customs Enforcement Bureau      19, IV
  Transportation Security Administration          49, XII
HOPE for Homeowners Program, Board of Directors   24, XXIV
     of
Housing, Office of, and Multifamily Housing       24, IV
     Assistance Restructuring, Office of
Housing and Urban Development, Department of      2, XXIV; 5, LXV; 24, 
                                                  Subtitle B
  Community Planning and Development, Office of   24, V, VI
       Assistant Secretary for
  Equal Opportunity, Office of Assistant          24, I
       Secretary for
  Federal Acquisition Regulation                  48, 24
  Federal Housing Enterprise Oversight, Office    12, XVII
       of
  Government National Mortgage Association        24, III
  Housing--Federal Housing Commissioner, Office   24, II, VIII, X, XX
       of Assistant Secretary for
  Housing, Office of, and Multifamily Housing     24, IV
       Assistance Restructuring, Office of
  Inspector General, Office of                    24, XII
  Public and Indian Housing, Office of Assistant  24, IX
       Secretary for
  Secretary, Office of                            24, Subtitle A, VII
Housing--Federal Housing Commissioner, Office of  24, II, VIII, X, XX
     Assistant Secretary for
Housing, Office of, and Multifamily Housing       24, IV
     Assistance Restructuring, Office of
Immigration and Customs Enforcement Bureau        19, IV
Immigration Review, Executive Office for          8, V
Independent Counsel, Office of                    28, VII
Independent Counsel, Offices of                   28, VI
Indian Affairs, Bureau of                         25, I, V
Indian Affairs, Office of the Assistant           25, VI
     Secretary
Indian Arts and Crafts Board                      25, II
Indian Health Service                             25, V
Industry and Security, Bureau of                  15, VII

[[Page 642]]

Information Resources Management, Office of       7, XXVII
Information Security Oversight Office, National   32, XX
     Archives and Records Administration
Inspector General
  Agriculture Department                          7, XXVI
  Health and Human Services Department            42, V
  Housing and Urban Development Department        24, XII, XV
Institute of Peace, United States                 22, XVII
Inter-American Foundation                         5, LXIII; 22, X
Interior, Department of                           2, XIV
  American Indians, Office of the Special         25, VII
       Trustee
  Endangered Species Committee                    50, IV
  Federal Acquisition Regulation                  48, 14
  Federal Property Management Regulations System  41, 114
  Fish and Wildlife Service, United States        50, I, IV
  Geological Survey                               30, IV
  Indian Affairs, Bureau of                       25, I, V
  Indian Affairs, Office of the Assistant         25, VI
       Secretary
  Indian Arts and Crafts Board                    25, II
  Land Management, Bureau of                      43, II
  National Indian Gaming Commission               25, III
  National Park Service                           36, I
  Natural Resource Revenue, Office of             30, XII
  Ocean Energy Management, Bureau of              30, V
  Reclamation, Bureau of                          43, I
  Safety and Enforcement Bureau, Bureau of        30, II
  Secretary of the Interior, Office of            2, XIV; 43, Subtitle A
  Surface Mining Reclamation and Enforcement,     30, VII
       Office of
Internal Revenue Service                          26, I
International Boundary and Water Commission,      22, XI
     United States and Mexico, United States 
     Section
International Development, United States Agency   22, II
     for
  Federal Acquisition Regulation                  48, 7
International Development Cooperation Agency,     22, XII
     United States
International Development Finance Corporation,    5, XXXIII; 22, VII
     U.S.
International Joint Commission, United States     22, IV
     and Canada
International Organizations Employees Loyalty     5, V
     Board
International Trade Administration                15, III; 19, III
International Trade Commission, United States     19, II
Interstate Commerce Commission                    5, XL
Investment Security, Office of                    31, VIII
James Madison Memorial Fellowship Foundation      45, XXIV
Japan-United States Friendship Commission         22, XVI
Joint Board for the Enrollment of Actuaries       20, VIII
Justice, Department of                            2, XXVIII; 5, XXVIII; 28, 
                                                  I, XI; 40, IV
  Alcohol, Tobacco, Firearms, and Explosives,     27, II
       Bureau of
  Drug Enforcement Administration                 21, II
  Federal Acquisition Regulation                  48, 28
  Federal Claims Collection Standards             31, IX
  Federal Prison Industries, Inc.                 28, III
  Foreign Claims Settlement Commission of the     45, V
       United States
  Immigration Review, Executive Office for        8, V
  Independent Counsel, Offices of                 28, VI
  Prisons, Bureau of                              28, V
  Property Management Regulations                 41, 128
Labor, Department of                              2, XXIX; 5, XLII
  Benefits Review Board                           20, VII
  Employee Benefits Security Administration       29, XXV
  Employees' Compensation Appeals Board           20, IV
  Employment and Training Administration          20, V
  Federal Acquisition Regulation                  48, 29
  Federal Contract Compliance Programs, Office    41, 60
       of
  Federal Procurement Regulations System          41, 50
  Labor-Management Standards, Office of           29, II, IV

[[Page 643]]

  Mine Safety and Health Administration           30, I
  Occupational Safety and Health Administration   29, XVII
  Public Contracts                                41, 50
  Secretary of Labor, Office of                   29, Subtitle A
  Veterans' Employment and Training Service,      41, 61; 20, IX
       Office of the Assistant Secretary for
  Wage and Hour Division                          29, V
  Workers' Compensation Programs, Office of       20, I, VI
Labor-Management Standards, Office of             29, II, IV
Land Management, Bureau of                        43, II
Legal Services Corporation                        45, XVI
Libraries and Information Science, National       45, XVII
     Commission on
Library of Congress                               36, VII
  Copyright Royalty Board                         37, III
  U.S. Copyright Office                           37, II
Management and Budget, Office of                  5, III, LXXVII; 14, VI; 
                                                  48, 99
Marine Mammal Commission                          50, V
Maritime Administration                           46, II
Merit Systems Protection Board                    5, II, LXIV
Micronesian Status Negotiations, Office for       32, XXVII
Military Compensation and Retirement              5, XCIX
     Modernization Commission
Millennium Challenge Corporation                  22, XIII
Mine Safety and Health Administration             30, I
Minority Business Development Agency              15, XIV
Miscellaneous Agencies                            1, IV
Monetary Offices                                  31, I
Morris K. Udall Scholarship and Excellence in     36, XVI
     National Environmental Policy Foundation
Museum and Library Services, Institute of         2, XXXI
National Aeronautics and Space Administration     2, XVIII; 5, LIX; 14, V
  Federal Acquisition Regulation                  48, 18
National Agricultural Library                     7, XLI
National Agricultural Statistics Service          7, XXXVI
National and Community Service, Corporation for   2, XXII; 45, XII, XXV
National Archives and Records Administration      2, XXVI; 5, LXVI; 36, XII
  Information Security Oversight Office           32, XX
National Capital Planning Commission              1, IV, VI
National Counterintelligence Center               32, XVIII
National Credit Union Administration              5, LXXXVI; 12, VII
National Crime Prevention and Privacy Compact     28, IX
     Council
National Drug Control Policy, Office of           2, XXXVI; 21, III
National Endowment for the Arts                   2, XXXII
National Endowment for the Humanities             2, XXXIII
National Foundation on the Arts and the           45, XI
     Humanities
National Geospatial-Intelligence Agency           32, I
National Highway Traffic Safety Administration    23, II, III; 47, VI; 49, V
National Imagery and Mapping Agency               32, I
National Indian Gaming Commission                 25, III
National Institute of Food and Agriculture        7, XXXIV
National Institute of Standards and Technology    15, II; 37, IV
National Intelligence, Office of Director of      5, IV; 32, XVII
National Labor Relations Board                    5, LXI; 29, I
National Marine Fisheries Service                 50, II, IV
National Mediation Board                          5, CI; 29, X
National Oceanic and Atmospheric Administration   15, IX; 50, II, III, IV, 
                                                  VI
National Park Service                             36, I
National Railroad Adjustment Board                29, III
National Railroad Passenger Corporation (AMTRAK)  49, VII
National Science Foundation                       2, XXV; 5, XLIII; 45, VI
  Federal Acquisition Regulation                  48, 25
National Security Council                         32, XXI; 47, II
National Technical Information Service            15, XI
National Telecommunications and Information       15, XXIII; 47, III, IV, V
   Administration
[[Page 644]]

National Transportation Safety Board              49, VIII
Natural Resource Revenue, Office of               30, XII
Natural Resources Conservation Service            7, VI
Navajo and Hopi Indian Relocation, Office of      25, IV
Navy, Department of                               32, VI
  Federal Acquisition Regulation                  48, 52
Neighborhood Reinvestment Corporation             24, XXV
Northeast Interstate Low-Level Radioactive Waste  10, XVIII
     Commission
Nuclear Regulatory Commission                     2, XX; 5, XLVIII; 10, I
  Federal Acquisition Regulation                  48, 20
Occupational Safety and Health Administration     29, XVII
Occupational Safety and Health Review Commission  29, XX
Ocean Energy Management, Bureau of                30, V
Oklahoma City National Memorial Trust             36, XV
Operations Office                                 7, XXVIII
Patent and Trademark Office, United States        37, I
Payment From a Non-Federal Source for Travel      41, 304
     Expenses
Payment of Expenses Connected With the Death of   41, 303
     Certain Employees
Peace Corps                                       2, XXXVII; 22, III
Pennsylvania Avenue Development Corporation       36, IX
Pension Benefit Guaranty Corporation              29, XL
Personnel Management, Office of                   5, I, IV, XXXV; 45, VIII
  Federal Acquisition Regulation                  48, 17
  Federal Employees Group Life Insurance Federal  48, 21
       Acquisition Regulation
  Federal Employees Health Benefits Acquisition   48, 16
       Regulation
  Human Resources Management and Labor Relations  5, XCVII
       Systems, Department of Homeland Security
Pipeline and Hazardous Materials Safety           49, I
     Administration
Postal Regulatory Commission                      5, XLVI; 39, III
Postal Service, United States                     5, LX; 39, I
Postsecondary Education, Office of                34, VI
President's Commission on White House             1, IV
     Fellowships
Presidential Documents                            3
Presidio Trust                                    36, X
Prisons, Bureau of                                28, V
Privacy and Civil Liberties Oversight Board       6, X
Procurement and Property Management, Office of    7, XXXII
Public and Indian Housing, Office of Assistant    24, IX
     Secretary for
Public Contracts, Department of Labor             41, 50
Public Health Service                             42, I
Railroad Retirement Board                         20, II
Reclamation, Bureau of                            43, I
Refugee Resettlement, Office of                   45, IV
Relocation Allowances                             41, 302
Research and Innovative Technology                49, XI
     Administration
Rural Business-Cooperative Service                7, XVIII, XLII
Rural Development Administration                  7, XLII
Rural Housing Service                             7, XVIII, XXXV
Rural Utilities Service                           7, XVII, XVIII, XLII
Safety and Environmental Enforcement, Bureau of   30, II
Saint Lawrence Seaway Development Corporation     33, IV
Science and Technology Policy, Office of, and     32, XXIV; 47, II
     National Security Council
Secret Service                                    31, IV
Securities and Exchange Commission                5, XXXIV; 17, II
Selective Service System                          32, XVI
Small Business Administration                     2, XXVII; 13, I
Smithsonian Institution                           36, V
Social Security Administration                    2, XXIII; 20, III; 48, 23
Soldiers' and Airmen's Home, United States        5, XI
Special Counsel, Office of                        5, VIII
Special Education and Rehabilitative Services,    34, III
     Office of
State, Department of                              2, VI; 22, I; 28, XI
  Federal Acquisition Regulation                  48, 6

[[Page 645]]

Surface Mining Reclamation and Enforcement,       30, VII
     Office of
Surface Transportation Board                      49, X
Susquehanna River Basin Commission                18, VIII
Tennessee Valley Authority                        5, LXIX; 18, XIII
Trade Representative, United States, Office of    15, XX
Transportation, Department of                     2, XII; 5, L
  Commercial Space Transportation                 14, III
  Emergency Management and Assistance             44, IV
  Federal Acquisition Regulation                  48, 12
  Federal Aviation Administration                 14, I
  Federal Highway Administration                  23, I, II
  Federal Motor Carrier Safety Administration     49, III
  Federal Railroad Administration                 49, II
  Federal Transit Administration                  49, VI
  Maritime Administration                         46, II
  National Highway Traffic Safety Administration  23, II, III; 47, IV; 49, V
  Pipeline and Hazardous Materials Safety         49, I
       Administration
  Saint Lawrence Seaway Development Corporation   33, IV
  Secretary of Transportation, Office of          14, II; 49, Subtitle A
  Transportation Statistics Bureau                49, XI
Transportation, Office of                         7, XXXIII
Transportation Security Administration            49, XII
Transportation Statistics Bureau                  49, XI
Travel Allowances, Temporary Duty (TDY)           41, 301
Treasury, Department of the                       2, X; 5, XXI; 12, XV; 17, 
                                                  IV; 31, IX
  Alcohol and Tobacco Tax and Trade Bureau        27, I
  Community Development Financial Institutions    12, XVIII
       Fund
  Comptroller of the Currency                     12, I
  Customs and Border Protection                   19, I
  Engraving and Printing, Bureau of               31, VI
  Federal Acquisition Regulation                  48, 10
  Federal Claims Collection Standards             31, IX
  Federal Law Enforcement Training Center         31, VII
  Financial Crimes Enforcement Network            31, X
  Fiscal Service                                  31, II
  Foreign Assets Control, Office of               31, V
  Internal Revenue Service                        26, I
  Investment Security, Office of                  31, VIII
  Monetary Offices                                31, I
  Secret Service                                  31, IV
  Secretary of the Treasury, Office of            31, Subtitle A
Truman, Harry S. Scholarship Foundation           45, XVIII
United States Agency for Global Media             22, V
United States and Canada, International Joint     22, IV
     Commission
United States and Mexico, International Boundary  22, XI
     and Water Commission, United States Section
U.S. Copyright Office                             37, II
Utah Reclamation Mitigation and Conservation      43, III
     Commission
Veterans Affairs, Department of                   2, VIII; 38, I
  Federal Acquisition Regulation                  48, 8
Veterans' Employment and Training Service,        41, 61; 20, IX
     Office of the Assistant Secretary for
Vice President of the United States, Office of    32, XXVIII
Wage and Hour Division                            29, V
Water Resources Council                           18, VI
Workers' Compensation Programs, Office of         20, I, VII
World Agricultural Outlook Board                  7, XXXVIII

[[Page 647]]



List of CFR Sections Affected



All changes in this volume of the Code of Federal Regulations (CFR) that 
were made by documents published in the Federal Register since January 
1, 2016 are enumerated in the following list. Entries indicate the 
nature of the changes effected. Page numbers refer to Federal Register 
pages. The user should consult the entries for chapters, parts and 
subparts as well as sections for revisions.
For changes to this volume of the CFR prior to this listing, consult the 
annual edition of the monthly List of CFR Sections Affected (LSA). The 
LSA is available at www.govinfo.gov. For changes to this volume of the 
CFR prior to 2001, see the ``List of CFR Sections Affected, 1949-1963, 
1964-1972, 1973-1985, and 1986-2000'' published in 11 separate volumes. 
The ``List of CFR Sections Affected 1986-2000'' is available at 
www.govinfo.gov.

                                  2016

21 CFR
                                                                   81 FR
                                                                    Page
Chapter I
507 Nomenclature change............................................49897
    Policy statement........................................57784, 75693
507.3 Amended.......................................................3717
    Regulation at 80 FR 56337 eff. date confirmed in part..........64060
507.5 (e)(5) revised................................................3717
507.7 (b)(2)(i)(B) and (ii) revised.................................3717
507.19 (b)(2) revised...............................................3717
507.27 (b) revised..................................................3717
507.33 (c)(1) revised...............................................3717
507.36 (a)(2) introductory text, (3) introductory text, (5) and 
        (b)(5) revised..............................................3717
507.47 (b)(1)(i)(A) and (B)(1) revised..............................3718
507.50 (c)(1) revised...............................................3718
507.51 (a)(4)(iii) revised..........................................3718
507.65 (e) revised..................................................3718
507.69 (a)(1) revised...............................................3718
510.600 (c)(1) table and (2) table amended....3324, 17606, 36788, 48702, 
                                                            59133, 67151
514 Authority citation revised.....................................29141
    Technical correction...........................................89848
514.80 (b)(4) introductory text amended; (b)(4)(i) revised.........29141
514.87 Added.......................................................29141
514.111 (a)(12) added..............................................60221
514.200 Revised....................................................52997
515 Technical correction...........................................89848
515.10 (b)(8) amended..............................................60221
516.1318 Removed....................................................3324
520 Drug application approvals withdrawn...........................36790
520.88b (b)(1)(ii)(B) amended......................................17607
520.100 (b)(3) removed.............................................22523
    (b)(3) and (4) removed.........................................59133
520.110 (b) amended................................................48702
    (d)(3) amended.................................................94989
520.154b Heading revised; (a) amended..............................17607
520.284 Redesignated from 520.300..................................59133
520.284a Redesignated from 520.300a................................59133
520.284b Redesignated from 520.300b................................59133
520.284c Redesignated from 520.300c................................59133
520.292 Added......................................................59133
520.300 Redesignated as 520.284....................................59133
520.300a Redesignated as 520.284a..................................59133
520.300b Redesignated as 520.284b..................................59133
520.300c Redesignated as 520.284c..................................59133
520.441 (b)(2), (d)(1)(i)(A)(1), (2)(i)(A)(1), (4)(iii)(B), (C) 
        and (iv)(B) amended........................................17607

[[Page 648]]

    (b)(2) removed; (b)(3) and (4) redesignated as new (b)(2) and 
(3); (b)(1) and new (2) revised....................................22523
    (d)(1)(i)(A)(2), (2)(i)(A)(2), (4)(i)(A)(2), (B)(2), 
(ii)(A)(2), (B)(2), (iii)(C), (iv)(C), (5)(i)(A)(2), (ii)(A)(2), 
(iii)(C) and (iv)(C) amended.......................................94989
520.443 (b), (d)(1)(i), (2)(i) and (3)(i) amended..................17607
520.445 (b) amended................................................17607
    (d)(3) amended.................................................94989
520.446 (b)(1) amended.............................................17607
520.447 (b) amended................................................17607
520.823 (d)(2)(ii) amended.........................................17607
    (d)(1)(i), (iii), (2)(i), (iii), (3)(i) and (iii) revised......94989
520.905a (a) amended...............................................22523
520.928 (c) revised................................................67151
520.1010 (b)(3) amended............................................17607
520.1044a (d)(3) revised...........................................94989
520.1044b (b) Amended..............................................22523
520.1044c (d)(3) revised; (d)(4) removed...........................94989
520.1084 Added.....................................................36789
520.1193 (b)(2) amended............................................17607
520.1248 Added.....................................................22523
520.1263c (b) revised..............................................22523
    (b)(1), (d)(1)(iii), (2)(iii) and (3)(iii) amended.............94989
520.1265 (d)(3) added..............................................94989
520.1430 Heading revised...........................................36789
520.1484 (b)(2) and (3) amended....................................22523
    (e)(1)(iii) and (2)(iii) revised...............................94989
520.1660a Heading, (e)(1) and (3) revised..........................94989
520.1660d (b)(2) and (3) amended...................................22523
    (d)(1)(i)(A)(1), (3), (B)(1), (3), (ii)(A)(1), (3), (B)(1), 
(3), (C)(1), (3), (iii)(A), (C), (iv)(A), (iv)(C), (v)(A), (v)(C), 
(2)(i) and (iii) revised...........................................94989
520.1696b (b) amended.......................................22523, 36789
    (c) redesignated as (d); new (c) added; new (d)(3) revised.....94990
520.1705 (a) amended...............................................22523
520.1720a (b)(2) amended...........................................17607
520.1870 (b) revised...............................................17607
520.2041 (b) amended...............................................22523
520.2043 (b)(1) amended............................................17607
520.2044 (b)(2) amended............................................17607
520.2075 (a) and (c) revised.......................................59133
520.2086 Added.....................................................22523
520.2123b (d)(1)(i) removed; (d)(1)(ii) and (iii) redesignated as 
        new (d)(1)(i) and (ii); (d)(2) amended.....................94990
520.2123c (b) amended..............................................22523
520.2130 (b) amended...............................................48702
520.2134 (b) amended...............................................48702
520.2184 (d)(3) amended............................................94990
520.2200 (b) amended...............................................17607
    (d)(1)(iii) and (2)(iii) amended...............................94990
520.2218 (b) amended...............................................22523
    (d)(1)(ii) and (2)(ii) amended.................................94990
520.2220a (b)(1) amended...........................................22523
    Heading, (d)(1)(iii), (2)(iii) and (3)(iii) revised............94990
520.2260a (a)(1) amended...........................................17607
520.2260b (f)(1) amended...........................................22523
520.2261a (b) amended.......................................17607, 36789
    (d)(3) amended.................................................94990
520.2261b (b) amended..............................................17607
    (d)(1)(iii), (2)(iii), (3)(iii) and (4)(iii) amended...........94990
520.2325a (a)(1) and (3) amended...................................22523
    (a)(2) removed; (a)(3) and (4) redesignated as new (a)(2) and 
(3)................................................................36789
    (a)(3) amended.................................................59134
    (d) amended....................................................94990
520.2345c (d)(1)(iii) removed......................................67151
520.2345d (b)(5), (d)(1)(ii), (iii), (2)(ii) and (iii) amended.....17607
    (b)(2), (3), (d)(1)(iii) and (2)(iii) amended..................22523
    (d)(1)(iii), (2)(iii), (3)(iii) and (4)(iii) amended...........94990
520.2471 (d)(2) revised............................................17608
    (b) amended....................................................48702
520.2640 (b)(1) amended............................................48702
522.56 (b) amended.................................................17608
522.150 (b) amended................................................48702
522.224 Added......................................................67151
522.390 (b) amended................................................17608
522.535 Revised....................................................22524
522.540 (e)(2) amended.............................................17608
    (a)(2)(i) and (d)(2)(i) amended................................22524
522.690 (b)(3) amended.............................................36789
522.810 (b) amended................................................17608
522.840 (b) amended................................................48702
522.842 (a)(2) amended.............................................48702
522.1044 (b)(4) amended............................................22524
522.1055 Added.....................................................22524
    Revised........................................................59134
522.1066 (b) amended...............................................17608
522.1077 (b)(3) amended............................................36789
522.1182 (b)(6) amended; (b)(8) removed............................22524

[[Page 649]]

    (b) introductory text, (7) introductory text, (i) and (ii) 
amended............................................................59134
522.1192 (b)(2) amended............................................59134
522.1260 (b)(2) amended............................................59134
522.1315 (c)(1)(i) and (2)(i) amended..............................22524
522.1660a (b) amended..............................................22524
522.1662a (b)(3)(i)(b), (c)(3)(i), (d)(3)(i)(a), (e)(3)(i)(b), 
        (g)(3)(i)(b) and (k)(3)(ii) amended........................17608
    (h)(2) and (i)(2) amended......................................22524
522.1680 (b) amended...............................................36789
522.1684 Added.....................................................36789
    (b) amended....................................................48702
522.1696a (b)(2) amended...........................................22524
522.1696b (b)(1) amended...........................................22524
522.1870 (a), (c)(1)(i), (iii), (2)(i) and (iii) revised...........67151
522.1940 (a)(2) amended............................................48702
522.2005 (b)(1) amended............................................36789
522.2112 (b) amended...............................................48702
522.2120 (b) amended...............................................22524
522.2220 (b)(3) amended............................................22524
522.2260 (b) amended...............................................17608
522.2471 (b) amended...............................................48703
522.2476 (a)(1) amended............................................48703
522.2477 (b)(1) amended............................................48703
522.2615 (b) amended...............................................22524
522.2630 (d)(1)(iii)(A) revised....................................67151
522.2640 (b)(1) amended............................................48703
    Revised........................................................67151
524.916 (b) amended................................................48703
524.998 Added......................................................67152
524.1044g (b)(3) amended...........................................17608
    (b)(3) correctly amended.......................................18749
524.1044h (a) and (b) revised......................................59134
524.1193 (b)(2) amended............................................22524
    (b)(2) correctly amended.......................................25328
524.1445 (b) amended...............................................48703
524.1484k Heading revised..........................................22524
    Heading correctly revised......................................25328
528.2010 Added.....................................................17608
529.400 (a) footnote 1 removed.....................................67152
529.539 Added......................................................17608
529.1660 (b)(2) amended............................................22524
    (d)(3) added...................................................94991
556.70 (b) amended; (c) added......................................17608
556.275 (b)(2)(i) amended; (b)(3) and (4) redesignated as (b)(4) 
        and (5); new (b)(3) and (c) added..........................22524
556.283 (b)(3) and (4) revised.....................................17608
556.480 Removed....................................................94994
556.690 Removed....................................................17608
556.748 (c) revised................................................36789
556.765 (b)(1)(i) revised; (b)(1)(ii) and (c) added................17608
558 Drug application approvals withdrawn.............36790, 59135, 95025
558.3 (b)(1)(i) and (ii) revised; (b)(13) and (14) added...........57800
    Regulation at 81 FR 57800 eff. date confirmed..................85873
558.4 (c) amended; eff. 4-6-16.....................................11665
    (d) table amended.........................17608, 36790, 59134, 94995
558.15 Removed.....................................................11665
558.55 (d)(2)(ii) amended..........................................17609
558.58 (e)(4) amended..............................................17609
    (e)(6) amended.................................................67152
    (e)(2), (7), (8), (10) and (11) removed; (f) added.............94995
558.59 Revised..............................................67152, 94995
558.68 (e)(3) removed..............................................17609
    (b) amended....................................................48703
    (a) and (e) revised............................................59134
    (c) and (d) redesignated as (d) and (c); (e)(1)(i) and (2)(i) 
amended............................................................67152
558.76 (e)(2) removed; (e)(3) redesignated as new (e)(2) and 
        revised....................................................17609
    (e)(2)(iii) through (xvi) redesignated as (e)(2)(iv) through 
(xvii); new (e)(2)(iii) added......................................94995
558.128 (e)(7)(ii) amended.........................................17609
    (e)(7)(xi) amended.............................................67152
    Revised........................................................94995
558.140 (b)(2) amended.............................................63054
    (d) redesignated as (e); new (d) added.........................95004
558.145 (a)(2) removed.............................................63054
    Removed........................................................95004
558.175 (d)(2) amended.............................................17609
    (b) amended; (c) and (e) added; (d)(5) and (6) removed.........95004
558.195 (e)(1)(ii) amended.........................................17609
    (e)(1)(i) table, (2)(i) table, (3)(i)1 table, (ii)1 table, 
(i)2 table and (ii)2 table amended.................................22525
    (e)(1)(vi), (2)(iii) and (v) amended...........................67152
    (e)(1)(iv), (v), (vi), (2)(ii), (iv) and (vii) removed; (e)(4) 
added..............................................................95004
558.198 (d)(1)(ii) and (2)(ii) amended.............................17609
    (d)(1)(iv) and (v) removed; (d)(3) added.......................95004
558.248 (a) and (b) revised; (d)(1)(iii) removed...................36790

[[Page 650]]

    (d) redesignated as (e); new (d) added; (a) and new (e) 
revised............................................................95004
558.258 (e)(2)(vi) and (vii) amended...............................17609
    (e)(2)(ii) through (v) removed; (e)(6) added...................95005
558.261 (c)(2)(i) and (ii) redesignated as (c)(2)(ii) and (i); new 
        (c)(2)(ii) revised; (c)(4) added...........................17609
    (c) and (d) redesignated as (d) and (c)........................67152
558.265 (d)(1)(vi) and (2)(ii) amended.............................17609
    (d)(1)(iii), (iv) and (vii) removed; (d)(4) added..............95005
558.274 (a)(1), (c)(1)(i), (ii), (2)(i) and (ii) amended...........48703
    (c)(1)(ii) and (2)(ii) removed.................................59135
    Revised........................................................95005
558.295 (b) removed................................................67152
558.300 (e)(2), (3) and (9) amended................................17609
    (e)(4) through (7) removed; (f) added..........................95005
558.305 (e)(2), (3), (5) and (6) removed; (e)(4) redesignated as 
        new (e)(2); (f) added......................................95005
558.311 (e)(1)(iv), (x) and (xv) amended...........................17609
    (e)(1)(i), (vi), (vii) and (xv) amended; (e)(1)(iii), (v) and 
(xx) through (xxviii) removed; (e)(5)(i) redesignated as 
(e)(5)(ii); new (e)(5)(i) and (iii) added..........................95005
558.325 (d)(3) revised.............................................67152
    Revised........................................................95005
558.340 (c)(1)(i) and (ii) redesignated as (c)(2) and (3); new 
        (c)(2) revised.............................................22525
558.342 (b)(2), (e)(1)(i) through (iv), (ix) and (x) amended.......48703
    (e)(1)(iv), (ix), (x) and (xi) amended.........................67152
    (e)(1)(iii), (iv), (viii), (ix) and (xi) removed; (e)(2) 
revised............................................................95009
558.355 (f)(1)(iii)(b), (xxiv), (xxix) introductory text, (b), 
        (xxx) introductory text, (b), (2)(ii) introductory text, 
        (b), (iii) introductory text, (a), (b), (4)(ii) 
        introductory text, (b), (iii) introductory text, (b), (v) 
        introductory text and (b) amended..........................17609
    (f)(1)(xxiv) and (xxv) introductory text revised; (f)(1)(xxx), 
(4)(iv) and (v) removed............................................22525
    (b)(1), (2), (4) through (9), (11), (12), (14), 
(f)(1)(xiii)(b), (xxi)(b), (xxii)(b), (xxviii)(b), (xxix)(b), 
(xxxi)(b), (3)(i)(b)(2)(iii), (ii)(b), (xii)(b), (4)(ii)(b), 
(iii)(b) and (6)(i)(b)(2)(iii) amended.............................48703
    (f)(1)(xxviii) removed; (f)(8)(i) and (ii) revised.............59135
    (a) and (b) and (f)(8) revised; (f)(1)(viii), (ix), (xiii), 
(xiv), (xxi), (xxii), (xxxi), (2)(iv), (3)(ii) and (xii) removed 
                                                                   95009
558.363 (d)(1)(iv) introductory text, (B) and (3)(ii) amended......17609
    (a)(1), (3), (8), (d)(1)(ii)(B), (iii)(B), (iv)(B), (v)(B) and 
(vi)(B) amended....................................................48703
    (d)(1)(vi) removed.............................................59135
558.364 (d) redesignated as (e); (a) through (d) revised...........95009
558.366 (d) amended................................................17609
    (b) and (d) amended............................................48703
    (d) amended....................................................67153
    (d) table amended; (e) added...................................95009
558.435 Removed....................................................95009
558.450 (d)(5)(v) amended..........................................17609
    Revised........................................................95009
558.455 (d) revised; (e)(1)(i), (2)(i), (3)(i), (4)(i), (ii) and 
        (iv) removed; (e)(4)(v) amended............................95012
558.460 Removed....................................................95013
558.485 (e)(1)(v) through (xii) removed; (e)(3) added..............95013
558.500 (b), (e)(1)(i) through (iv), (2)(i) through (xiii) and 
        (3)(i) through (iv) amended................................48703
    (e)(1)(ii), (iii), (iv), (2)(iv), (ix), (x) and (xiii) 
removed; (e)(4) added..............................................95013
558.515 (d) amended................................................17609
    (d) table amended..............................................22525
    (d) table amended; (e) added...................................95013
558.550 (d)(1)(iii)(a), (c), (vi)(a), (c), (xx)(A), (C), (xxi)(A), 
        (C), (3)(ii) introductory text, (B), (iii) introductory 
        text, (B), (v) introductory text and (B) amended...........17609
    (b)(1), (d)(1)(xvi)(c), (xx)(C), (xxii)(B), (xxiii)(b), 
(3)(ii)(B), (iii)(B), (v)(B) and (4)(i)(b) amended; (b)(2) 
removed; (b)(3) redesignated as new (2)............................22525

[[Page 651]]

    (d)(1)(xxii)(B) amended........................................48703
    (d)(1)(xxii) removed...........................................59135
    (d)(1)(x), (xi), (xiii) and (xvi) removed; (d)(4) revised......95013
558.555 (d)(2) amended.............................................17609
    (d)(3), (4), (5), (e)(2), (3) and (4) removed; (f) added.......95013
558.575 Heading and (a) revised; (b), (c) and (d) redesignated as 
        (c), (d) and (e); new (b) and (d) added....................95013
558.582 Revised....................................................95013
558.586 (b) amended................................................22525
    Revised........................................................95013
558.612 (e)(1)(i) and (iii) removed; (e)(1)(ii) and (iv) 
        redesignated as new (e)(1)(i) and (ii); (e)(2) added.......95015
558.618 (b), (e)(1)(i) and (2)(i) through (iii) amended............48703
    (e)(2)(ii) and (iii) amended...................................59135
    (c) and (d) redesignated as (d) and (c)........................67153
558.625 (b)(3) removed; (b)(4) and (5) redesignated as new (b)(3) 
        and (4)....................................................36790
    (b)(1), (f)(2)(i), (iii) and (vii) revised; (f)(2)(viii) and 
(ix) removed.......................................................59135
    (b)(1) amended.................................................48703
    (d) removed; (c), (e) and (f) redesignated as (d), (c) and 
(e); (b), new (d) and new (e) revised..............................95015
558.630 (b)(1) amended.............................................48703
    (b)(1) revised.................................................59135
    Revised........................................................95021
558.633 Added......................................................36790
    (d)(1) revised.................................................67153
558.635 Revised....................................................95022
558.665 (e)(2) through (6), (8), (10), (11) and (12) amended.......48703
    (e)(5), (6), (11) and (12) removed; (f) added..................95025
558.680 (d)(1)(ii), (iii), (iv), (vi), (vii), (viii) and (2)(ii) 
        amended....................................................17609
    (d)(1)(x) removed; (e)(3) added................................95025
570.3 (f), (h) and (k) revised; (i) amended; (n) added.............55051
    Regulation at 81 FR 55051 eff. date corrected..................62004
570.30 (a) and (i) amended; (b), (c) and (d) revised...............55052
    Regulation at 81 FR 55052 eff. date corrected..................62004
570.35 (a), (b)(1), (3) and (4) revised; (c) removed...............55052
    Regulation at 81 FR 55052 eff. date corrected..................62004
570.38 (a) revised.................................................55052
    Regulation at 81 FR 55052 eff. date corrected..................62004
570.203--570.280 (Subpart E) Added.................................55052
    Regulation at 81 FR 55052 eff. date corrected..................62004
573.304 Added......................................................35611
    Regulation at 81 FR 35611 eff. date confirmed; comment period 
extended...........................................................41441
573.496 Added......................................................86269
573.696 Added......................................................67154
    Introductory text and (b) revised..............................95027
589.2001 (b)(1)(vi)(B) amended......................................5596

                                  2017

21 CFR
                                                                   82 FR
                                                                    Page
Chapter I
507 Policy statement...............................................51345
507.75 Revised.....................................................14147
510 Drug application approvals withdrawn...........................12170
510.600 (c)(1) table and (2) table amended...11508, 12168, 21690, 43484, 
                                                                   58555
511.1 Heading and (c)(6) revised; (c)(1) and (2) amended; 
        (c)(1)(i), (ii), (2)(i) and (ii) added.....................61446
516.2065 Added.....................................................12169
520.48 (b) amended.................................................21690
520.88g (b) amended................................................11508
    (c)(1)(ii) and (2)(ii) amended.................................43484
    Heading, (a), and (b) revised..................................58556
520.304 (b)(1) and (2) revised; (b)(3) removed.....................43484
520.370 (c)(2) amended.............................................12169
520.540c (b) amended...............................................11508
520.955 (b) revised................................................12169
520.980 (b) amended................................................21690
520.1189 Added.....................................................12169
520.1445 (c)(1)(ii) revised........................................58556
520.1454 (b) amended...............................................21690
520.2041 (b) amended...............................................12169
520.2086 (c)(2) revised............................................12169
520.2325b (b) amended..............................................12169
522 Drug application approvals withdrawn....................12170, 21694
522.90b (a) amended................................................21690
522.304 (b) revised................................................43484

[[Page 652]]

522.313c (b) amended...............................................12169
522.540 (d)(2)(i) amended..........................................11508
522.970 (b)(1) revised; (b)(3), (e)(2)(ii)(B) and (iii) removed; 
        (e)(2)(ii) amended.........................................43484
522.1002 (b) removed; (c) redesignated as new (b)..................21690
    (b)(1) revised.................................................43484
522.1055 (b) amended........................................11508, 21690
522.1182 (b)(3) amended............................................11508
522.1335 (b) amended...............................................58556
522.1362 (b) amended...............................................21690
522.1380 (b) amended...............................................11508
522.1450 (b) amended...............................................21690
522.1660a (e)(1)(ii) amended.......................................43484
522.1662a (e)(1) revised; (e)(3)(i)(c) amended.....................21690
522.2075 (c) revised...............................................12170
522.2470 (b), (c)(1)(i), (ii), and (2) revised.....................58556
522.2473 (b) amended...............................................21691
522.2477 (b)(2) revised; (d)(4) added..............................21691
    (b)(2) revised; (d)(1)(iii) through (4)(iii) amended; (d)(5) 
added..............................................................43484
522.2615 (b) amended...............................................11508
524 Drug application approvals withdrawn...........................11509
524.998 (c)(2) added...............................................43485
524.1005 (b)(1) amended............................................11508
524.1450 (b)(1) amended............................................21691
524.1465 (b) amended...............................................11508
524.1580a (d)(3) amended...........................................58556
529 Drug application approvals withdrawn...........................12170
529.1030 (d)(1)(ii), (2)(iii), and (3) revised; (d)(2)(i) table 
        and (ii) table amended.....................................58556
529.1186 (b) amended...............................................12170
558 Drug application approvals withdrawn...........................11509
558.4 (d) table amended.....................................21691, 43485
558.58 (f)(4) and (5) removed......................................58557
558.68 (e)(1)(ii) revised..........................................11509
558.76 (e)(1)(vii) removed.........................................21691
558.115 (d)(4) revised.............................................21691
558.128 (b)(1), (e)(1)(i), (v), (3)(v), (4)(iii) amended; 
        (e)(4)(xxiv) and (xxv) redesignated as (e)(4)(xxv) and 
        (xxvi); new (e)(4)(xxiv) added.............................21691
    (e)(4)(iii), (xi), (xii), (xiii), (5)(ii), (iii) and (6)(v) 
amended............................................................43485
558.140 (b)(1) amended.............................................21691
558.325 (e)(1)(ii) revised.........................................12170
    (e)(2)(vii) and (viii) redesignated as (xvi) and (xvii); new 
(e)(2)(vii) added..................................................21691
558.366 (e) revised................................................21692
    (e) removed....................................................58557
558.450 (e)(4)(iii) redesignated as (e)(4)(v); new (e)(4)(iii) and 
        (iv) added.................................................11512
558.485 (e)(1)(iv) removed.........................................21692
558.550 (d)(5) added...............................................21692
558.625 (d)(2) revised; (d)(4) and (5) added; (e)(2)(iv), (v), 
        (vi), (vii), (viii), (ix), (x), (xi), (xii), (xiii), (xiv) 
        and (xv) amended...........................................21692
    (e)(1)(vii), (ix), (2)(ii), (iii), (vi) through (xv) amended 
                                                                   43485
558.635 (a) and (e) revised; (d)(1) and (2) added..................11512
    (e)(1) revised.................................................21692
558.680 (e) removed; (d)(3) added..................................21693
573.170 (c) and (d) redesignated as (d) and (e); new (c) and new 
        (d)(3) added; new (e) introductory text revised............52209
573.480 (b)(3) and (4) redesignated as (b)(4) and (5); new (b)(3) 
        and (b)(4)(iii) added; new (b)(5) introductory text 
        revised....................................................52209
573.492 Added......................................................38596

                                  2018

21 CFR
                                                                   83 FR
                                                                    Page
Chapter I
507 Policy statement.................................................598
507 Notification............................................22193, 46878
510.600 (c)(1) table and (2) table amended....13634, 14586, 48943, 64739
510.600 (c)(1) table and (2) table amended; eff. 4-9-18............13635
514 Notification...................................................30534
520 Drug application approvals withdrawn...........................48950
520.48 (b) amended.................................................13635
520.88f (c)(2) amended.............................................64740
520.390a (b)(1)(i) amended.........................................48944
520.441 (b)(3) amended.............................................48944
520.443 (b) amended................................................48944
520.580 (b)(1) and (2) amended.....................................48944
520.596 Redesignated from 520.600; new 520.596 revised.............48944
520.598 Added......................................................48945
520.600 Redesignated as 520.596....................................48944
520.600 Added......................................................48945
520.602 Added......................................................48945

[[Page 653]]

520.622a (a)(6) amended............................................48945
520.622b (c)(2) amended............................................48945
520.622c (b)(6) amended............................................48945
520.763a (b) amended...............................................48945
520.763b (b) amended...............................................48945
520.763c (b) amended...............................................48945
520.816 (b) amended................................................64740
520.905d (a) and (b) revised.......................................48945
520.1044c (b)(2) amended...........................................48945
520.1084 (b) amended...............................................14587
520.1182 Removed...................................................48945
520.1199 (a) introductory text and (c)(2) amended..................14587
520.1242a (b)(3) amended...........................................48945
520.1263c (b)(1) and (2) amended...................................48945
520.1265 (b)(2) amended............................................48945
520.1286 Added.....................................................48945
520.1408 (b)(1) amended............................................48946
520.1447 (d)(1)(ii) amended........................................13635
520.1660d (b)(4) amended...........................................48946
520.1720a (b)(2) amended...........................................48946
520.1804 Removed...................................................48946
520.1840 (b)(2) and (d)(4) removed; (b)(3) and (4) redesignated as 
        new (b)(2) and new (3).....................................48946
520.1900 (b)(1) amended............................................48946
520.2220a (b)(1) and (2) amended...................................48946
520.2335 Added.....................................................64740
520.2345d (b)(4) amended...........................................48946
520.2380a (b)(1) and (d)(1)(i) removed.............................48946
520.2640 (b)(1) and (2) revised....................................14587
520.2645 (d)(1) and (2) revised....................................13635
522 Drug application approval withdrawn.....................13637, 48950
522.300 Removed; eff. 4-9-18.......................................13635
522.540 (b)(2) and (c)(2) revised; eff. 4-9-18.....................13635
522.970 (b)(1) amended.............................................48946
522.1044 (b)(3) amended............................................48946
522.1077 Revised...................................................64740
522.1081 (b)(1) amended; eff. 4-9-18...............................13635
522.1182 (b)(4) amended............................................48946
522.1222 (b) amended...............................................48946
522.1242 (b) amended...............................................48946
522.1410 (b) amended...............................................48946
522.1660a (b) amended..............................................48946
522.1662a (h)(3)(ii) amended.......................................13635
522.1662a (a)(2), (b)(2), (g)(2), and (h)(2) amended...............48946
522.1680 (b) amended...............................................13635
522.1720 (b)(3) amended............................................48946
522.2220 (b)(1) and (3) amended....................................48946
522.2424 (b) amended...............................................48946
522.2470 (b) and (c) revised.......................................14587
522.2483 (b) amended...............................................48946
522.2662 (b)(1) amended............................................48946
524 Drug application approvals withdrawn...........................48950
524.814 (b) revised................................................48946
524.815 Added......................................................48946
524.900 (b) amended................................................48946
524.957 (a) revised................................................64740
524.970 Added......................................................13635
524.1132 (a) revised...............................................13635
524.1193 (b)(2) amended............................................13635
524.1448 Added.....................................................64740
524.1580a (b)(1) amended...........................................48947
524.1580b (b) amended..............................................48947
526.1696b (b) amended..............................................14587
529.1044a (b) amended..............................................48947
556.275 (b)(3)(ii) added...........................................48947
556.286 (c) amended................................................13635
556.428 (c) added..................................................64741
556.440 Removed....................................................48947
556.445 Revised....................................................64741
558 Drug application approvals withdrawn...........................48950
558.4 (d) table amended.....................................13635, 48947
558.68 (e)(1)(iii) and (iv) added..................................14587
558.68 (e)(1)(ii) revised; (e)(1)(v) added.........................64741
558.76 (e)(1)(viii) removed; (e)(2)(xiii) through (xvii) 
        redesignated as (e)(2)(xiv) through (xviii); new 
        (e)(2)(xiii) added; new (e)(2)(xiv) revised................64741
558.78 (d)(3)(vii) added...........................................64741
558.95 (d)(5)(viii) revised; (d)(5)(ix), (x), and (xi) 
        redesignated as (d)(5)(x), (xi), and (xii); new (d)(5)(ix) 
        added......................................................64741
558.128 (e)(3) table and (4) table amended.........................13636
558.128 (e)(4)(ii), (vii), (viii), (ix), and (xviii) through 
        (xxvi) amended.............................................14588
558.128 (e)(4)(xi) and (xiii) amended..............................48947
558.128 (e)(3)(iv) amended.........................................64741
558.185 (b) revised; (e)(1) removed; (e)(2) and (3) redesignated 
        as new (e)(1) and (2)......................................48947
558.195 (e)(2)(v) removed..........................................48947
558.205 (a) revised; (b), (c), and (d) redesignated as (c), (d), 
        and (e); new (b) added.....................................48947
558.311 (b)(9) and (e)(1)(xix) amended.............................14588

[[Page 654]]

558.311 (e)(5) revised.............................................48947
558.325 (d)(2) revised.............................................13637
558.325 (e)(2)(xiv) revised........................................14588
558.325 (e)(1)(ii) redesignated as (e)(1)(v); (e)(1)(iv) and (vii) 
        through (x) added..........................................48947
558.325 (e)(1)(iv) amended.........................................64741
558.342 (e)(1) tables amended; (e)(1)(v) through (xi) removed; 
        (e)(2)(i), (ii), and (iii) redesignated as (e)(2)(ii), 
        (iii), and (iv); (e)(1)(iii), (iv), and new (e)(2)(i) 
        added......................................................48948
558.363 Revised....................................................64741
558.364 Redesignated as 558.365; new 558.364 added.................64742
558.365 Removed....................................................48948
558.365 Redesignated from 558.364..................................64742
558.366 Revised....................................................64743
558.450 (e)(5)(iv) amended.........................................48948
558.485 Revised....................................................48948
558.485 (e)(2) amended.............................................64744
558.575 (e)(2)(ii) amended.........................................13637
558.625 (e)(2)(ii) and (iii) revised...............................48949
573.480 (b) introductory text and (5)(iii)(B) revised.................20
573.480 (b) introductory text and (4)(ii) amended..................66618
573.550 Added......................................................49486
573.615 Added......................................................19935
573.940 (d) and (e) added...........................................8930

                                  2019

21 CFR
                                                                   84 FR
                                                                    Page
500.82 (b) amended.................................................32992
507 Notification...................................................29054
507.31 (c)(5) revised..............................................12491
507.130 (c)(2)(ii) revised.........................................12491
510.600 (c)(1) table and (2) table amended.....8971, 12493, 39182, 53310
520 Drug application approvals withdrawn............................8982
520.43 (c)(2) revised...............................................8972
520.43 (b) amended.................................................39182
520.48 (b) amended..................................................8972
520.100 (b)(1) and (2) amended......................................8972
520.284a (b) amended...............................................39182
520.284b (b) amended...............................................39182
520.284c (b) amended...............................................39182
520.304 (b)(1) amended.............................................12493
520.390a (b)(2)(i) amended..........................................8972
520.420 Revised....................................................39183
520.447 (b) amended.................................................8972
520.462 (c) redesignated as (d); new (c) added.....................32992
520.462 (b) amended................................................39183
520.522 (b) revised................................................12493
520.538 (b) amended................................................39183
520.540b (b)(2) amended.............................................8972
520.622a (a)(3) amended.............................................8972
520.804 (b) amended................................................39183
520.812 (a), (b)(1), and (2) revised; (b)(3) added..................8972
520.812 (a)(1)(i) amended..........................................53310
520.823 (b) amended.................................................8972
520.928 (b) amended................................................39183
520.930 (b) amended................................................39183
520.970 (b)(2) amended..............................................8972
520.1044c (b)(2) amended............................................8972
520.1100 (b)(2) amended.............................................8972
520.1150 Added.....................................................12494
520.1192 (b)(2) amended.............................................8972
520.1192 (b)(1) amended............................................39183
520.1193 (b)(1) amended............................................39183
520.1195 (b)(1) amended............................................39183
520.1196 (b) amended...............................................39183
520.1197 (b) amended...............................................39183
520.1198 (b)(1) and (3) amended....................................39183
520.1242a (b)(4) amended............................................8972
520.1263c (b)(2) amended............................................8972
520.1265 (b)(2) amended.............................................8972
520.1441 Revised...................................................12494
520.1484 (b)(2) amended.............................................8973
520.1615 (b) amended...............................................39183
520.1660d (b)(5), (7), (d)(1)(ii)(A)(3), (B)(3), (C)(3), and 
        (iii)(C) amended............................................8973
520.1696b (b) amended...............................................8973
520.1696c (b) amended..............................................39183
520.1696d (b) amended..............................................39183
520.1720a (b)(3) amended............................................8973
520.1720d (b) amended...............................................8973
520.1760 (a) and (c)(1) revised....................................39183
520.1840 (c) added.................................................32992
520.1855 (b) amended...............................................39183
520.2041 (b) amended................................................8973
520.2044 (b)(3) amended.............................................8973
520.2046 (b)(2) amended.............................................8973
520.2123a (b) amended...............................................8973
520.2123b (b) amended...............................................8973
520.2123c (b) amended...............................................8973
520.2170 (b) amended...............................................39183
520.2220a (b)(2) amended............................................8973
520.2260b (c)(1) and (e)(1) amended.................................8973
520.2261b (b) amended...............................................8973
520.2325b (c) redesignated as (d); new (c) added...................32992
520.2325b (d)(3) revised...........................................53310

[[Page 655]]

520.2345d (b)(4), (d)(1)(iii), and (2)(iii) amended.................8973
520.2380a (b)(2) amended...........................................39183
520.2380b (b) amended..............................................39183
520.2380c (b) amended..............................................39183
520.2380d (b) amended..............................................39183
520.2380e redesignated as 520.2380f; new section redesignated from 
        520.2380f; new (b) amended.................................39183
520.2380f redesignated as 520.2380e; new section redesignated from 
        520.2380e..................................................39183
520.2640 (b)(2) amended.............................................8973
520.2640 (c) revised...............................................32992
522.144 (b) amended................................................39183
522.147 (b) amended.................................................8973
522.150 (c) redesignated as (d); new (c) added.....................32992
522.224 (c) revised.................................................8973
522.313b (a), (b), and (e)(2)(iii) revised.........................39183
522.313b (a)(2) and (e)(1)(iii) revised............................53311
522.468 (c) added..................................................32992
522.480 (b)(1) amended..............................................8973
522.540 (a)(2)(i), (b)(2), and (c)(2) amended.......................8973
522.690 (b)(3) amended..............................................8973
522.770 (c) revised................................................32992
522.812 (b)(2) and (e)(3)(i)(B) removed; (b)(3) and (e)(3)(i)(C) 
        redesignated as new (b)(2) and new (e)(3)(i)(B); (b)(1), 
        (e)(3)(i)(A), and new (B) revised;..........................8973
522.812 (b)(1) and (2) revised.....................................53311
522.814 (b) amended................................................39184
522.820 (b) amended.................................................8973
522.850 (c) redesignated as (d); new (c) added.....................32992
522.850 (b) amended................................................39184
522.930 (b) amended................................................39184
522.970 (b)(1) amended..............................................8973
522.1010 (b)(2) amended.............................................8973
522.1014 (b) amended...............................................39184
522.1044 (b)(4) amended.............................................8973
522.1077 (b)(3) amended.............................................8973
522.1077 (c) and (d) redesignated as (d) and (e); new (c) added....32992
522.1077 (b)(4) amended............................................39184
522.1079 (c) redesignated as (d); new (c) added....................32992
522.1145 (e)(2)(i) amended.........................................39184
522.1150 (b) amended...............................................39184
522.1160 (b)(1) and (2) revised; (c)(1)(i) redesignated as 
        (c)(1)(i)(A); new (c)(1)(i)(A) heading and (B) added.......39184
522.1192 (b)(2) amended.............................................8974
522.1192 (c) added.................................................32992
522.1192 (b)(1) amended............................................39184
522.1193 (b) and (e)(3) revised....................................39184
522.1242 (c) redesignated as (d); new (c) added....................32992
522.1260 (b)(4) amended.............................................8974
522.1362 (b) amended...............................................39184
522.1452 (b) amended...............................................39184
522.1660a (b) amended...............................................8974
522.1662a (k)(2) amended............................................8974
522.1662a (h)(3)(iii) amended......................................12494
522.1662a (l) added................................................32992
522.1680 (b) amended................................................8974
522.1696a (b)(1), (2), (d)(1)(ii), (2), (ii), and (iii) amended.....8974
522.1696b (b)(2), (d)(2)(i)(A), and (iii)(A) amended................8974
522.1720 (b)(2) amended.............................................8974
522.1870 (b) amended................................................8974
522.1883 (b) amended................................................8974
522.1885 (b) amended...............................................39184
522.1962 (b)(2) amended.............................................8974
522.2063 (b)(2) amended.............................................8974
522.2120 (c) and (d) redesignated as (d) and (e); new (c) added....32992
522.2220 (b)(3) amended.............................................8974
522.2444b (b) amended...............................................8974
522.2473 (b) amended................................................8974
522.2477 (c) added.................................................32992
522.2640 (b)(2) amended.............................................8974
522.2640 (c) revised...............................................32992
522.2662 (b)(2) amended.............................................8974
524 Drug application approvals withdrawn...........................39187
524.770 (c) amended................................................32993
524.814 (b) amended................................................39184
524.815 (b) amended................................................39184
524.916 Removed....................................................39184
524.920 (c) revised................................................32993
524.1044e (c) redesignated as (d); new (c) added...................32993
524.1193 (b)(1) amended......................................8974, 39184
524.1484g (b) amended..............................................39184
524.1484j (b) amended..............................................39184
524.1580a (b)(1) amended............................................8974
524.1600b (c) redesignated as (d); new (c) added...................32993
524.2099 Added.....................................................12494
524.2101 (b) amended...............................................39184
526.820 (b) amended.................................................8974
526.820 (c) redesignated as (d); new (c) added.....................32993

[[Page 656]]

526.1130 Heading revised; (c) redesignated as (d); new (c) added 
                                                                   53311
526.1696a (c) amended...............................................8974
526.1696d (c) redesignated as (d); new (c) added...................32993
528.1080 Added.....................................................12494
529.400 (c) redesignated as (d); new (c) added.....................32993
529.1030 (b) revised; (d)(1)(iv) and (2)(iv) added.................53311
529.1044a (b) amended...............................................8974
529.1660 (b)(1) and (2) amended.....................................8974
556 Revised........................................................32993
556.316 Added......................................................53311
556.370 Added......................................................12494
556.445 (a) added; (b) revised......................................8974
558 Drug application approvals withdrawn...........................39187
558.4 (d) tables amended..............................8974, 12495, 53311
558.58 (e)(3) through (6) redesignated as (e)(2) through (5); 
        (e)(9) redesignated as new (e)(6)..........................39184
558.68 (e)(1)(i) amended............................................8975
558.68 (c) amended.................................................33001
558.76 (e)(1)(ix) through (xvi) redesignated as (e)(1)(vii) 
        through (xiv)..............................................39185
558.95 (c) added...................................................33001
558.128 (e)(4)(iv) amended..........................................8975
558.128 (b)(1) and (e)(4)(xv) revised; (e)(4)(xvi) through (xxvi) 
        redesignated as (e)(4)(xvii) through (xxvii); new 
        (e)(4)(xvi) added..........................................39185
558.140 (e)(1) and (2) revised.....................................12495
558.175 (d) revised................................................12495
558.185 (c) revised................................................33001
558.195 (e)(1), (2), and (3) revised...............................12496
558.198 Redesignated as 558.205; new section redesignated from 
        558.205 and revised........................................12497
558.205 Redesignated as 558.198; new section redesignated from 
        558.198....................................................12497
558.205 (b), (d)(1), and (2) revised...............................12498
558.235 (a) revised; (b) redesignated as (d); new (b) and (c) 
        added......................................................33001
558.235 (b) amended................................................39185
558.248 (b) amended.................................................8975
558.254 Revised....................................................39185
558.258 (e)(2) revised.............................................12499
558.265 (b) and (d) revised.........................................8975
558.300 (e) revised................................................12499
558.300 (b) and (e)(1) through (6) amended; (f) removed............39185
558.311 (e)(5)(ii) through (v) redesignated as (e)(5)(iii) through 
        (vi); new (e)(5)(ii) added..................................8976
558.325 (e)(1)(vi) added............................................8976
558.325 (e)(1)(iii) added..........................................12501
558.325 (e)(2)(iii), (x), and (xvi) removed; (e)(2)(iv) through 
        (ix), (xi) through (xv), and (xvii) redesignated as 
        (e)(2)(iii) through (viii), (ix) through (xiii), and (xiv)
                                                                   39185
558.330 Added......................................................12501
558.330 (d) revised................................................53311
558.355 (b) and (f) revised; (c) added..............................8976
558.355 (f)(6)(i) amended; (f)(7)(iv) through (xi) redesignated as 
        (f)(7)(v) through (xii); new (f)(7)(iv) added..............53312
558.360 Revised....................................................39185
558.364 (d)(1)(i) revised...........................................8981
558.415 (d) revised................................................12501
558.450 (e)(5)(iii), (iv), and (v) redesignated as (e)(v), (iii), 
        and (iv); new (e)(5)(iv) and new (v) revised...............12502
558.464 (a) revised; (b) redesignated as (d); new (b) and (c) 
        added......................................................33001
558.465 (a) revised; (b) redesignated as (d); new (b) and (c) 
        added......................................................33001
558.550 (b) and (d) revised; (c) and (e) added......................8981
558.575 (b) and (e) revised........................................12502
558.600 Revised.............................................12503, 39186
558.625 (b)(1) through (4) revised..................................8982
558.625 (c) amended................................................33002
558.625 (e)(2)(vii) through (xv) redesignated as (e)(2)(ix) 
        through (xvii); new (e)(2)(vii) and (viii) added...........53312
558.630 (c) amended................................................33002
558.633 (e) revised................................................12504
573.492 Revised.....................................................6675
573.920 (d) removed; (e) through (h) redesignated as new (d) 
        through (g); (b), (c) introductory text, and new (g)(4) 
        revised; (c)(4), (5), and new (h) added.....................7993
573.940 (d) table amended...........................................7993

[[Page 657]]

                                  2020

21 CFR
                                                                   85 FR
                                                                    Page
Chapter I
500.1410 (a) revised...............................................18117
501.105 (t) introductory text revised..............................72908
507 Notification...................................................17008
507.62 (a) revised.................................................16554
507.65 (h) revised.................................................16554
507.69 (a)(1) revised..............................................16554
507.73 (c)(2) revised..............................................16554
507.75 Revised.....................................................16555
507.85 (a) and (b)(1) revised......................................16555
510.600 (c)(1) table and (2) table amended............4207, 18118, 45307
514 Technical correction...........................................59427
514.80 Table, (b)(1), (2)(i), (ii), (3), (4)(iv)(A), (C), and (v) 
        amended; (d) and (g) revised...............................45512
520 Drug application approvals withdrawn..............4210, 18125, 45311
520.88c (c) amended................................................18118
520.90a Redesignated from 520.90b..................................18118
520.90b Redesignated as 520.90a; new section redesignated from 
        520.90c....................................................18118
520.90c Redesignated as 520.90b; new section redesignated from 
        520.90f; new (b) and new (d) revised.......................18118
520.90d Removed....................................................18118
520.90e Removed....................................................18118
520.90f Redesignated as 520.90c....................................18118
520.260 (b)(2) amended.............................................18119
520.292 (b) amended.................................................4207
520.304 (b)(1) amended..............................................4207
520.455 (b) amended................................................18119
520.903c Redesignated from 520.903d................................18119
520.903d Redesignated as 520.903c; new section redesignated from 
        520.903e...................................................18119
520.903e Redesignated as 520.903d..................................18119
520.1263b Redesignated from 520.1263c..............................18119
520.1263c Redesignated as 520.1263b................................18119
520.1286 (c)(2) amended.............................................4208
520.1286 Revised...................................................18119
520.1310 (b) amended...............................................45307
520.1660d (d)(2)(ii) revised.......................................18119
520.1696a Redesignated from 520.1696b..............................18119
520.1696b Redesignated as 520.1696a; new section redesignated from 
        520.1696c..................................................18119
520.1696c Redesignated as 520.1696b; new section redesignated from 
        520.1696d..................................................18119
520.1696d Redesignated as 520.1696c................................18119
520.1720a (b)(4) and (5) removed; (b)(6) redesignated as new 
        (b)(4).....................................................45307
520.1807 Removed....................................................4208
520.2090 Added.....................................................45307
520.2218 (c) amended...............................................18119
520.2260b (a) through (f) and (g) redesignated as (b) through (g) 
        and (a)....................................................18119
520.2455 (b)(4) added..............................................18119
520.2455 (b)(2) amended............................................45308
520.2520d Heading revised; (c) added................................4208
520.2612 (c)(2)(i) revised..........................................4208
522 Drug application approvals withdrawn.....................4210, 18125
522.90b (b) amended.................................................4208
522.224 (b) amended.................................................4208
522.460 (b)(3) and (c)(1)(iv) added; (c)(1)(ii), (iii), and (2) 
        revised.....................................................4208
522.480 (b)(2) amended.............................................45308
522.650 (b) revised................................................18119
522.728 Added......................................................18119
522.900 Removed....................................................18119
522.1083 (a) and (c) revised.......................................45308
522.1367 (c)(1)(i) amended.........................................18119
522.1451 Revised....................................................4208
522.1662a (a) through (e) redesignated as (b) through (f); 
        (c)(3)(i)(a), (b), and (c) redesignated as (c)(3)(i)(A), 
        (B), (C), (ii)(A), (B), and (C); (e)(3)(i)(a), (b), and 
        (c) redesignated as (e)(3)(i)(A), (B), and (C); 
        (e)(3)(ii)(a) and (b) redesignated as (e)(3)(ii)(A) and 
        (B); (e)(3)(iii)(a), (b), and (c) redesignated as 
        (e)(3)(iii)(A), (B), and (C); (f)(3)(i)(a), (b), (c), 
        (ii)(a), (b), and (c) redesignated as (f)(3)(i)(A), (B), 
        (C), (ii)(A), (B), and (C); (g)(3)(i)(a), (b), (c), 
        (ii)(a), (b), and (c) redesignated as (g)(3)(i)(A), (B), 
        (C), (ii)(A), (B), and (C); (k) and (l) redesignated as 
        (j) and (a); new (e)(3)(iii)C) amended.....................18119
522.1696a (b)(1), (2), and (d)(2)(iii) amended.....................18120

[[Page 658]]

522.1696b (b)(1) and (d)(2)(iii)(B) amended; (d)(2)(i)(A) and (B) 
        removed....................................................18120
522.1697 Added.....................................................18120
522.1697 (b) amended...............................................45308
522.2092 Added.....................................................18120
522.2112 (b) amended................................................4208
524.981--524.2630 Undesignated center heading added................18120
524.1001 Added.....................................................18120
524.1044c (b) amended...............................................4208
524.1044f (b) amended...............................................4208
524.1146 (a) and (b) revised.......................................18120
524.1448 (b) amended...............................................45308
524.1484b Heading and (a) revised..................................45308
524.1742 Heading revised; (c) and (d) redesignated as (d) and (c); 
        new (d)(1)(i)(a) and (b) redesignated as (d)(1)(i)(A) and 
        (B); (d)(1) introductory text table heading added..........18120
524.2098 (b) amended........................................18120, 45308
526 Drug application approvals withdrawn...........................18125
526.464b Removed; new section redesignated from 526.464c...........18120
526.464c Redesignated as 526.464b..................................18120
529 Drug application approvals withdrawn............................4210
529.1115 (b) amended................................................4208
529.1150 (c) revised................................................4208
556.40 (c) amended.................................................18120
556.165 (c) amended................................................18121
556.168 Removed....................................................18121
556.230 (b)(3) removed.............................................18121
556.304 (c) amended................................................18121
556.344 (a), (b)(2)(i), and (ii) amended...........................18121
556.360 (b)(3) added; (c) revised..................................18121
556.500 (b)(6) added...............................................18121
556.510 (c) amended................................................18121
556.513 Removed.....................................................4209
556.660 (c) amended................................................18121
556.670 (c) amended................................................18121
556.685 (c) amended................................................18121
556.733 (a) amended................................................18121
556.746 (b)(4) added...............................................18121
556.750 (b)(4) removed.............................................18121
556.765 (b)(1) revised.............................................18121
558.4 (d) table amended.............................................4209
558.6 (c)(7) revised...............................................50784
558.55 (d)(5) added................................................18121
558.68 (e)(1)(ii), (iii), and (v) revised...........................4209
558.68 (e)(1)(iv) revised..........................................45308
558.76 (e)(2)(vii), (viii), and (xi) revised.......................18121
558.185 Removed....................................................18121
558.195 (e)(2)(ii) revised.........................................18121
558.235 (d) revised................................................45309
558.295 Revised....................................................45309
558.340 Revised....................................................45310
558.342 (e)(1)(iv) revised.........................................18122
558.348 Revised....................................................45310
558.355 (b) and (f)(6)(i) revised...................................4210
558.355 (e) removed; (f)(4)(iv) revised............................18122
558.430 (d) revised................................................45310
558.465 Revised....................................................45310
558.500 (e)(2) revised.............................................18122
558.500 (e)(1)(iii) and (iv) removed...............................45311
558.618 (e)(2)(ii) and (iii) revised...............................18123
558.625 (e)(2)(iv), (v), and (x) through (xiii) amended.............4210
558.625 (e)(2)(vi) and (ix) revised................................18124
558.635 (e)(1)(iv) revised.........................................18125
573.304 (b), (c), (d)(3), and (e)(2)(ii) revised...................14566
573.304 (d)(1) and (e)(1) amended..................................48650
573.940 (b) through (e) revised....................................33539
582.99 Revised.....................................................72908

                                  2021

   (Regulations published from January 1, 2021, through April 1, 2021)

21 CFR
                                                                   86 FR
                                                                    Page
Chapter I
510 Drug application approvals withdrawn...........................10819
510.600 (c)(1) table and (2) table amended..................10819, 13183
510.600 (c)(1) table amended.......................................14817
516.812 Added......................................................13184
520 Drug application approvals withdrawn...........................10819
520.100 (a)(3) removed; (b)(2) and (d)(2) introductory text 
        revised; (b)(3) added......................................13184
520.260 Revised....................................................10819
520.304 (b) revised; (c) removed; (d) redesignated as new (c)......13184
520.304 (a)(3) and (b)(3) added; (b)(1) and (2) revised............14817
520.530 (b) revised................................................14818

[[Page 659]]

520.531 (b)(1) revised.............................................14818
520.580 (b)(1) amended.............................................10819
520.812 (a) and (b) revised........................................13184
520.812 (b)(1) revised.............................................14818
520.903a (b) revised...............................................14818
520.903b (b) revised...............................................14818
520.903c (b) revised...............................................14818
520.903d (b) revised...............................................14818
520.905a (e)(5)(ii) and (6)(ii) revised; (e)(5)(iii) removed.......14818
520.998 Revised....................................................14818
520.1156 (b) revised...............................................14818
520.1192 (b)(2) revised............................................14818
520.1195 (b)(1) revised............................................14818
520.1443 (b) amended...............................................13184
520.1447 (b) amended...............................................13184
520.1454 (b) revised...............................................14818
520.1510 (b)(2) amended............................................13184
520.1720a (b)(5) added.............................................14819
520.1860 (b) revised...............................................14819
520.1870 (b) revised...............................................14819
520.1871 (b)(1) revised............................................14819
520.1872 (b) revised...............................................14819
520.2043 (b)(2) revised............................................14819
520.2138 Added.....................................................14819
520.2260b (b) heading and (e) heading added; (b)(1) and (e)(1) 
        revised....................................................14819
520.2455 (b)(4) amended............................................13184
520.2455 (b)(1) and (2) revised....................................14819
522 Drug application approvals withdrawn...........................10819
522.23 (b) revised.................................................14819
522.84 Removed.....................................................10819
522.234 (b) revised................................................14819
522.246 (b)(2) and (3) revised.....................................14819
522.518 Removed....................................................10819
522.536 (b) amended................................................13184
522.812 (b)(1) and (2) revised.....................................14819
522.955 (b)(2) revised.............................................14819
522.970 (b)(1) revised.............................................14819
522.995 (b) revised................................................14820
522.1010 (b)(3) revised............................................14820
522.1077 (e)(1)(ii) and (2) removed; (e)(1)(iii) through (vii) 
        redesignated as (e)(1)(ii) through (vi); (a)(3), (b), (d), 
        (e)(1)(i), new (ii), and new (iii) revised.................13184
522.1077 (b)(3) revised; (b)(4) removed; (b)(5) redesignated as 
        new (b)(4).................................................14820
522.1086 (b) revised...............................................14820
522.1182 (b)(1) introductory text revised..........................14820
522.1193 (e)(3)(i) revised.........................................14820
522.1222 (b) revised...............................................14820
522.1450 (b) revised...............................................14820
522.1620 Removed...................................................10819
522.1696a (d)(2)(iii) revised......................................14820
522.1720 (b)(2) revised............................................14820
522.1870 (b) revised...............................................14820
522.1890 Heading revised...........................................14820
522.2120 Revised...................................................14820
522.2662 (b)(3) revised............................................14820
524.450 (b) revised................................................14820
524.775 (b) revised................................................14820
524.802 (b) revised................................................14821
524.920 (b)(1) through (3) revised.................................14821
524.955 (b) revised................................................14821
524.957 (b) revised................................................14821
524.1140 (b) revised...............................................14821
524.1146 (b)(2) revised; (b)(3) added..............................13185
524.1146 (b)(1) through (3) revised................................14821
524.1193 (b)(2) amended............................................13185
524.1450 (b)(1) and (2) revised....................................14821
524.2080 Added.....................................................13185
524.2098 (b) amended...............................................13185
526.88 Heading, (a), (d) heading, (1), and (3) revised.............13185
526.313 (a) and (d) revised; (e) added.............................13185
526.363 (a) and (d) revised........................................13186
526.365 (a) and (d)(1) revised.....................................13186
526.464 Revised....................................................13186
526.464a Removed...................................................13186
526.464b Redesignated as 526.465...................................13186
526.465 Redesignated from 526.464b; heading, (a), and (b) revised 
                                                                   13186
526.820 Revised....................................................13186
526.1130 (a), (d) heading, (1), and (2) revised....................13186
526.1590 Revised...................................................13187
526.1696 Revised...................................................13187
526.1696a Removed..................................................13187
526.1696b Redesignated as 526.1697.................................13187
526.1696c Removed..................................................13187
526.1696d Redesignated as 526.1698.................................13187
526.1697 Redesignated from 526.1696b; heading, (a) and (d) 
        revised; (e) added.........................................13187
526.1698 Redesignated from 526.1696d; heading, (a), and (d) 
        revised; (e) added.........................................13187
526.1810 (a) and (d) heading revised; (d)(1) amended...............13188

[[Page 660]]

529.56 (b) revised.................................................14821
529.443 Added......................................................13188
529.1044a (b) revised..............................................14821
529.2110 Redesignated from 529.2150................................13188
529.2150 Redesignated as 529.2110..................................13188
556.38 (c) amended.................................................13188
556.165 (c) amended................................................13188
556.168 Added......................................................14821
556.170 (c) amended................................................13188
556.180 (c) amended................................................13188
556.185 (c) amended................................................13188
556.226 (c) amended................................................13188
556.300 (c) amended................................................13188
556.360 (c) amended................................................13188
556.510 (c) amended................................................13188
556.517 (c) revised................................................14821
556.670 (c) amended................................................13188
558.55 (a) revised; (b) and (d) redesignated as (d) and (e); new 
        (b) added..................................................14821
558.58 (b) revised; (c) and (d) redesignated as (d) and (c)........14821
558.68 (e)(1)(ii), (iii), and (v) revised..........................13188
558.68 (a) revised.................................................14821
558.76 (b) revised; (c) removed; (d) and (e) redesignated as (c) 
        and (d)....................................................14821
558.78 (b) revised.................................................14822
558.95 (b) and (d) redesignated as (d) and (e); new (b) and new 
        (e)(5) heading added; (a) and new (e)(5)(iii) revised......14822
558.128 (e)(4)(xv) and (xvi) revised...............................13189
558.128 (b) introductory text revised..............................14822
558.140 (b)(2) redesignated as (b)(3); new (b)(2) added; (b)(1) 
        and (e)(1) revised.........................................13189
558.140 (b) introductory text revised..............................14822
558.175 (d)(3) revised; (e) removed................................14822
558.185 Added......................................................14822
558.195 (b) revised................................................14822
558.258 (b) revised................................................14822
558.261 (e)(2)(ii) revised.........................................14822
558.295 (a) revised................................................14823
558.305 (b) revised................................................14823
558.311 (e)(5)(ii) through (vi) redesignated as (e)(5)(iii) 
        through (vii); new (e)(5)(ii) added........................13190
558.311 (e)(2) through (5) redesignated as new (e)(5) through (8); 
        (e) heading, introductory text, and new (2) through (4) 
        added; (a), (b), (d)(7), and (e)(1) revised; new (e)(6)(i) 
        table amended..............................................14823
558.325 (b) and (e)(1)(ix) revised.................................14824
558.342 (b)(2) amended; (e)(1)(i) revised..........................13190
558.342 (b) revised................................................14825
558.355 (b) introductory text, (d)(9)(i), (ii), (10)(i), and (ii) 
        revised....................................................14825
558.363 (a) revised................................................14825
558.364 (d)(1)(ii) revised.........................................14825
558.366 (b) revised................................................14825
558.450 (e)(5)(iv) revised.........................................14825
558.465 Removed....................................................14826
558.470 Added......................................................14826
558.485 (b) introductory text revised..............................14826
558.500 (b) amended; (e)(2)(i), (iii), and (vi) revised............13190
558.500 (b) revised................................................14826
558.515 (a) revised; (b), (d), and (e) redesignated as (d), (e), 
        and (f); new (b) added.....................................14826
558.550 (a), (b), (e)(1)(i), and (2)(i) revised; (e)(3)(i) through 
        (iv) redesignated as (e)(3)(ii) through (v); (e)(3) 
        heading and (i) added......................................14826
558.555 (b) revised................................................14826
558.575 (b) introductory text revised..............................14827
558.600 (a) and (d) revised........................................14827
558.612 (b) revised................................................14827
558.618 (b) revised................................................14827
558.680 (b), (d)(1)(i), (v), and (2)(i) revised....................14827


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