[Title 21 CFR ]
[Code of Federal Regulations (annual edition) - April 1, 2003 Edition]
[From the U.S. Government Printing Office]



[[Page i]]

          

                    21


          Part 500 to 599

                         Revised as of April 1, 2003

Food and Drugs





          Containing a codification of documents of general 
          applicability and future effect
          As of April 1, 2003
          With Ancillaries
          Published by
          Office of the Federal Register
          National Archives and Records
          Administration

A Special Edition of the Federal Register



[[Page ii]]






                     U.S. GOVERNMENT PRINTING OFFICE
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[[Page iii]]




                            Table of Contents



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

  Title 21:
          Chapter I--Food and Drug Administration, Department 
          of Health and Human Services (Continued)                   3
  Finding Aids:
      Material Approved for Incorporation by Reference........     547
      Table of CFR Titles and Chapters........................     549
      Alphabetical List of Agencies Appearing in the CFR......     567
      List of CFR Sections Affected...........................     577



[[Page iv]]





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

                     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 
issues of the Federal Register. These two publications must be used 
together to determine the latest version of any given rule.
    To determine whether a Code volume has been amended since its 
revision date (in this case, April 1, 2003), consult the ``List of CFR 
Sections Affected (LSA),'' which is issued monthly, and the ``Cumulative 
List of Parts Affected,'' which appears in the Reader Aids section of 
the daily Federal Register. These two lists will identify the Federal 
Register page number of the latest amendment of any given rule.

EFFECTIVE AND EXPIRATION DATES

    Each volume of the Code contains amendments published in the Federal 
Register since the last revision of that volume of the Code. Source 
citations for the regulations are referred to by volume number and page 
number of the Federal Register and date of publication. Publication 
dates and effective dates are usually not the same and care must be 
exercised by the user in determining the actual effective date. In 
instances where the effective date is beyond the cut-off date for the 
Code a note has been inserted to reflect the future effective date. In 
those instances where a regulation published in the Federal Register 
states a date certain for expiration, an appropriate note will be 
inserted following the text.

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 
amendments to existing regulations in the CFR. These OMB numbers are 
placed as close as possible to the applicable recordkeeping or reporting 
requirements.

OBSOLETE PROVISIONS

    Provisions that become obsolete before the revision date stated on 
the cover of each volume are not carried. Code users may find the text 
of provisions in effect on a given date in the past by using the 
appropriate numerical list of sections affected. For the period before 
January 1, 2001, consult either the List of CFR Sections Affected, 1949-
1963, 1964-1972, 1973-1985, or 1986-2000, published in 11 separate 
volumes. For the period beginning January 1, 2001, a ``List of CFR 
Sections Affected'' is published at the end of each CFR volume.

INCORPORATION BY REFERENCE

    What is incorporation by reference? Incorporation by reference was 
established by statute and allows Federal agencies to meet the 
requirement to publish regulations in the Federal Register by referring 
to materials already published elsewhere. For an incorporation to be 
valid, the Director of the Federal Register must approve it. The legal 
effect of incorporation by reference is that the material is treated as 
if it were published in full in the Federal Register (5 U.S.C. 552(a)). 
This material, like any other properly issued regulation, has the force 
of law.
    What is a proper incorporation by reference? The Director of the 
Federal Register will approve an incorporation by reference only when 
the requirements of 1 CFR part 51 are met. Some of the elements on which 
approval is based are:
    (a) The incorporation will substantially reduce the volume of 
material published in the Federal Register.
    (b) The matter incorporated is in fact available to the extent 
necessary to afford fairness and uniformity in the administrative 
process.
    (c) The incorporating document is drafted and submitted for 
publication in accordance with 1 CFR part 51.
    Properly approved incorporations by reference in this volume are 
listed in the Finding Aids at the end of this volume.
    What if the material incorporated by reference cannot be found? If 
you have any problem locating or obtaining a copy of material listed in 
the Finding Aids of this volume as an approved incorporation by 
reference, please contact the agency that issued the regulation 
containing that incorporation. If, after contacting the agency, you find 
the material is not available, please notify the Director of the Federal 
Register, National Archives and Records Administration, Washington DC 
20408, or call (202) 741-6010.

CFR INDEXES AND TABULAR GUIDES

    A subject index to the Code of Federal Regulations is contained in a 
separate volume, revised annually as of January 1, entitled CFR Index 
and Finding Aids. This volume contains the Parallel Table of Statutory 
Authorities and Agency Rules (Table I). A list of CFR titles, chapters, 
and parts and an alphabetical list of agencies publishing in the CFR are 
also included in this volume.
    An index to the text of ``Title 3--The President'' is carried within 
that volume.
    The Federal Register Index is issued monthly in cumulative form. 
This index is based on a consolidation of the ``Contents'' entries in 
the daily Federal Register.
    A List of CFR Sections Affected (LSA) is published monthly, keyed to 
the revision dates of the 50 CFR titles.

[[Page vii]]


REPUBLICATION OF MATERIAL

    There are no restrictions on the republication of material appearing 
in the Code of Federal Regulations.

INQUIRIES

    For a legal interpretation or explanation of any regulation in this 
volume, contact the issuing agency. The issuing agency's name appears at 
the top of odd-numbered pages.
    For inquiries concerning CFR reference assistance, call 202-741-6000 
or write to the Director, Office of the Federal Register, National 
Archives and Records Administration, Washington, DC 20408 or e-mail 
[email protected].

SALES

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register. The NARA site also contains links to GPO Access.

                              Raymond A. Mosley,
                                    Director,
                          Office of the Federal Register.

April 1, 2003.



[[Page ix]]



                               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-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, 2003.

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

[[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

Cross References: Animal and Plant Health Inspection Service, Department 
  of Agriculture: See Animals and Animal Products, 9 CFR chapter I.

  Food Safety and Inspection Service, Meat and Poultry Inspection, 
Department of Agriculture: See Animals and Animal Products, 9 CFR 
chapter III.

  Federal Trade Commission: See Commercial Practices, 16 CFR chapter I.

  U.S. Customs Service, Department of the Treasury: See Customs Duties, 
19 CFR chapter I.

  Internal Revenue Service, Department of the Treasury: See Internal 
Revenue, 26 CFR chapter I.

  Bureau of Alcohol, Tobacco, and Firearms, Department of the Treasury: 
See Alcohol, Tobacco Products and Firearms, 27 CFR chapter I.

[[Page 3]]



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




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


  Editorial Note: For nomenclature changes to chapter I, see 59 FR 
14366, Mar. 28, 1994.

         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
509             Unavoidable contaminants in animal food and 
                    food-packaging material.................          33
510             New animal drugs............................          37
511             New animal drugs for investigational use....          52
514             New animal drug applications................          56
515             Medicated feed mill license.................          88
520             Oral dosage form new animal drugs...........          93
522             Implantation or injectable dosage form new 
                    animal drugs............................         214
524             Ophthalmic and topical dosage form new 
                    animal drugs............................         292
526             Intramammary dosage forms...................         319
529             Certain other dosage form new animal drugs..         325
530             Extralabel drug use in animals..............         331
556             Tolerances for residues of new animal drugs 
                    in food.................................         337
558             New animal drugs for use in animal feeds....         357
564

[Reserved]

570             Food additives..............................         485
571             Food additive petitions.....................         492
573             Food additives permitted in feed and 
                    drinking water of animals...............         497
579             Irradiation in the production, processing, 
                    and handling of animal feed and pet food         514
582             Substances generally recognized as safe.....         515
584             Food substances affirmed as generally 
                    recognized as safe in feed and drinking 
                    water of animals........................         540

[[Page 4]]

589             Substances prohibited from use in animal 
                    food or feed............................         540
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.
500.35 Animal feeds contaminated with Salmonella microorganisms.
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.

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

    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.

    The provisions of part 113 of this chapter shall apply to the 
manufacture, processing or packing of low-acid foods in hermetically 
sealed containers, and intended for use as food for animals.

[61 FR 37681, July 19, 1996]



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 
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.''

[[Page 6]]

    (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 
(d) and (e) of this chapter. For animal feeds bearing or containing 
anthelmintic drugs covered by approved applications, the labeling 
revisions required for compliance with this section may be placed into 
effect without the submission of supplemental applications as provided 
for in Sec.  514.9 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.



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 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 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]



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 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

[[Page 7]]

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.  500.35  Animal feeds contaminated with Salmonella microorganisms.

    (a) Investigations by the Food and Drug Administration, the Centers 
for Disease Control of the U.S. Public Health Service, the Animal Health 
Division of the Agricultural Research Service, U.S. Department of 
Agriculture, and by various State public health agencies have revealed 
that processed fish meal, poultry meal, meat meal, tankage, and other 
animal byproducts intended for use in animal feed may be contaminated 
with Salmonella bacteria, an organism pathogenic to man and animals. 
Contamination of these products may occur through inadequate heat 
treatment of the product during its processing or through 
recontamination of the heat-treated product during a time of improper 
storage or handling subsequent to processing.
    (b) Articles used in food for animals are included within the 
definition of

[[Page 8]]

food in section 201(f) of the Federal Food, Drug, and Cosmetic Act. 
Further, Salmonella contamination of such animal feeds having the 
potentiality for producing infection and disease in animals must be 
regarded as an adulterant within the meaning of section 402(a) of the 
act. Therefore, the Food and Drug Administration will regard as 
adulterated within the meaning of section 402(a) of the act shipments of 
the following when intended for animal feed and encountered in 
interstate commerce and found upon examination to be contaminated with 
Salmonella microorganisms: Bone meal, blood meal, crab meal, feather 
meal, fish meal, fish solubles, meat scraps, poultry meat meal, tankage, 
or other similar animal byproducts, or blended mixtures of these.

[40 FR 13802, Mar. 27, 1975, as amended at 54 FR 18279, Apr. 28, 1989]



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 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.

[[Page 9]]

    (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.
    (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-

[[Page 10]]

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 
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

[[Page 11]]

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 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

[[Page 12]]

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 under Sec.  5.10 of this 
chapter) that no residue of that compound will be found in the food 
produced from those animals 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 Dockets Management Branch (HFA-305), Food and Drug 
Administration, rm. 1-23, 12420 Parklawn Dr., Rockville, MD 20857. 
Requests for these guidance documents should be identified with Docket 
No. 83D-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]



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.

[[Page 13]]

    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 residue in a specific 
edible tissue corresponding to a maximum lifetime risk of cancer in the 
test animals of 1 in 1 million.
    So means the concentration of the 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. For the purpose of this 
subpart, FDA will also assume that this So will correspond to 
the concentration of residue of carcinogenic concern in the total human 
diet that represents no significant increase in the risk of cancer to 
people.
    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]



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 analyze the data from the bioassays using a 
statistical extrapolation procedure.
    (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.

[[Page 14]]

    (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]



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 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

[[Page 15]]

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.



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, 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.

[[Page 16]]



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 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,

[[Page 17]]

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.
    (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

[[Page 18]]

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.
    (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.

[[Page 19]]

    (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 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.

[[Page 20]]

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 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:

[[Page 21]]

    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 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.

[[Page 22]]



          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 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.

[[Page 23]]

    (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 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

[[Page 24]]

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. 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

[[Page 25]]

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.

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

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.

[[Page 26]]

    (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).
    (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

[[Page 27]]

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 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

[[Page 28]]

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 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:

[[Page 29]]

    (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, 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.

[[Page 30]]

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

    (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 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 
(except the requirement that food falling below the applicable standard 
of fill of container shall bear the general statement of substandard 
fill specified in

[[Page 31]]

Sec.  564.14(b) of this chapter), the mislabeled food product, including 
any food product that fails to bear the general statement of substandard 
fill specified in Sec.  564.14(b) of this chapter, 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]



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 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,

[[Page 32]]

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 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.

[[Page 33]]

    (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]



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

[[Page 34]]

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 Dockets Management 
Branch 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 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:

[[Page 35]]

    (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, 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

[[Page 36]]

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 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.

[[Page 37]]



     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.
    (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 
Dockets Management Branch, Food and Drug Administration, rm. 1-23, 12420 
Parklawn Dr., Rockville, MD 20857.

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

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

510.300 Records and reports concerning experience with new animal drugs 
          for which an approved application is in effect.

[[Page 38]]

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.
510.302 Reporting forms.
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 New animal drug requirements regarding free-choice 
          administration in feeds.

    Subpart F--Animal Use Exemptions From Certification and Labeling 
                              Requirements

510.515 Animal feeds bearing or containing new animal drugs subject to 
          the provisions of section 512(n) of the act.

              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 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

[[Page 39]]

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) The term sponsor means the person responsible for an 
investigation of a new animal drug, including responsibility for 
compliance with applicable provisions of the act and regulations. 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.

[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]



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.



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

[[Page 40]]

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 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

[[Page 41]]

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 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]

[[Page 42]]



                     Subpart D--Records and Reports



Sec.  510.300  Records and reports concerning experience with new animal drugs for which an approved application is in effect.

    (a) On receiving notification that an application submitted pursuant 
to Sec.  514.1 of this chapter for a new animal drug is approved, the 
applicant shall establish and maintain such records and make such 
reports as are specified in this section to facilitate a determination 
as to whether there may be grounds for suspending or withdrawing 
approval of the application or whether any applicable regulation should 
be amended or repealed. The applicant shall maintain adequately 
organized and indexed files containing full reports of information 
pertinent to the safety or effectiveness of the new animal drug that 
have not previously been submitted as part of his application for the 
drug and which are received or otherwise obtained by him from any 
source, as follows:
    (1) Unpublished reports of clinical or other animal experience, 
studies, investigations, and tests conducted by the applicant or 
reported to him by any person involving the new animal drug that is the 
subject of the application or any related drugs. An adequate summary and 
bibliography of reports in the scientific literature would ordinarily 
suffice. (The application must identify at the time of each report 
submission, each drug he considers related to the subject drug.)
    (2) Experience, investigations, studies, or tests involving the 
chemical or physical properties or any other properties of the new 
animal drug, such as its behavior or properties in relation to 
microorganisms, including both the effects of the drug on microorganisms 
and the effect of microorganisms on the drug.
    (3) For information required by this section, adequate 
identification of its source, when known, including the name and post 
office address of the person who furnishes such information.
    (4) Copies of all mailing pieces and other labeling, and, if it is a 
prescription new animal drug or a veterinary feed directive drug, all 
advertising other than that contained in the application used in 
promoting the drug, and copies of the currently used package labeling 
that gives full information for use of the drug whether or not such 
labeling is contained in the application.
    (5) Information concerning the quantity of the new animal drug 
distributed in a manner and form that facilitates estimates of the 
incidence of any adverse effects reported to be associated with the use 
of the drug. This does not require disclosure of financial, pricing, or 
sales data.
    (6) Information concerning any previously unreported changes from 
the conditions described in an application conforming to the conditions 
of Sec.  514.8(a)(5) of this chapter.
    (b) The applicant shall submit to the Food and Drug Administration 
copies of the records and reports described in paragraph (a) of this 
section, except routine assay and control records, appropriately 
identified with the new animal drug application(s) to which they relate, 
as follows:
    (1) Immediately upon receipt by the applicant, complete records or 
reports covering information of the following kinds:
    (i) Information concerning a mixup in the new animal drug or its 
labeling with another article.
    (ii) Information concerning any bacteriological or significant 
physical or other change or deterioration in the new animal 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.
    (2) As soon as possible, and in any event within 15 working days of 
its receipt by the applicant, complete records of reports concerning any 
information of the following kinds:
    (i) Information concerning any unexpected side effects, injury, 
toxicity, or sensitivity reaction or any unexpected incidence or 
severity thereof associated with clinical use, 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 
the Food and Drug Administration as

[[Page 43]]

types of information that may be submitted at other designated 
intervals. Unexpected as used in this subdivision refers to conditions 
or developments not previously submitted as part of the new animal drug 
application, or conditions and developments occurring at a rate higher 
than that shown by information previously submitted as part of the 
application.
    (ii) Information concerning any unusual failure of the new animal 
drug to exhibit its expected pharmacological activities.
    (3) When mailing pieces, any other labeling, and advertising are 
devised for promotion of the new animal drug, specimens shall be 
submitted at the time of initial dissemination of such labeling and at 
the time of initial publication of any advertisement for a prescription 
drug. Mailing pieces and labeling designed to contain samples of a drug 
shall be complete except for the omission of the drug.
    (4) All the kinds of information described in paragraph (a) of this 
section, other than that submitted under the provisions of paragraphs 
(b) (1), (2), and (3) of this section, shall be submitted as follows 
unless otherwise ordered in a written communication from the 
Commissioner:
    (i) At intervals within 6 months beginning with the date of approval 
of the new animal drug application during the first year following such 
date, and at yearly intervals thereafter.
    (ii) Whenever an applicant is required to submit reports under the 
provisions of paragraph (b)(4)(i) of this section with respect to more 
than one approved application for preparations containing the same new 
animal drug so that the same item(s) of information is (are) required to 
be reported for more than one application, he may elect to submit as a 
part of the report for one such application all the information common 
to such applications in lieu of reporting separately and repetitively on 
each. The applicant shall state when this is done and identify all the 
new animal drug applications for which the reports are submitted.
    (iii) The submitted copies of records and reports shall include all 
the required information that was received or otherwise obtained by the 
applicant during the designated intervals.
    (5) On written order of the Commissioner, within the time stated in 
such order or agreed to by the applicant and the Commissioner, any 
designated records or reports containing the kinds of information 
described in this section shall be submitted.
    (c) The applicant shall, upon request of any properly authorized 
officer or employee of the Department at reasonable times, permit such 
officers to have access to and copy and verify any records and reports 
established and maintained under the provisions of this section.
    (d) If the Food and Drug Administration finds 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 the provisions of this section, or 
that the applicant has refused to permit access to or copying of, or 
verification of such records or reports, the Commissioner shall give the 
applicant notice and opportunity for a hearing on the question of 
whether to withdraw the approval of the application, as provided in 
Sec.  514.200 of this chapter.
    (e) Upon written request of the applicant stating reasonable grounds 
therefor, the Commissioner will make available any information in 
possession of the Food and Drug Administration of the kinds the 
applicant is required to maintain under the provisions of this section, 
except information readily available to the applicant from other sources 
or information which the Commissioner concludes is confidential.
    (f) The applicant required to establish and maintain records and 
make reports required by this section includes any person whose name 
appears on the labeling of the drug as its manufacturer, packer, or 
distributor under an approval or who is engaged in the manufacturing, 
processing, packing, or labeling of the drug under an approval of the 
new animal drug application or any supplement to it; however, to avoid 
unnecessary duplication in the submission of reports, any such 
applicant's obligation to submit a report may be met by its submission 
on his behalf,

[[Page 44]]

designated as such, by another person responsible for reporting.

[40 FR 13807, Mar. 27, 1975, as amended at 65 FR 76928, Dec. 8, 2000]

    Effective Date Note: At 68 FR 15364, Mar. 31, 2003, Sec.  510.300 
was removed, effective June 30, 2003.



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) 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.
    (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 
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 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 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]



Sec.  510.302  Reporting forms.

    (a) The information described in Sec.  510.300, except that 
described in paragraphs (b) (1) and (2) of that section, shall be 
submitted appropriately identified with the new animal drug 
application(s) to which they relate in duplicate on Form FD-2301 
``Transmittal of Periodic Reports and Promotional Material for New 
Animal Drugs.''
    (b) All adverse experiences with new animal drugs as described in 
Sec.  510.300(b)(2) or Sec.  510.301(b) whether or not related to a 
required periodic report submitted on a Form FD-2301, shall be reported 
on Form FD-1932 ``Adverse Drug Reaction'' (except as provided in 
paragraph (c) of this section). Reports of adverse drug experiences may 
be submitted initially in the form of a written communication, but any 
such communication shall be followed promptly (but not necessarily 
within the prescribed 15 working days) by a completed Form FD-1932. A 
separate ``Adverse Drug Reaction'' form should be submitted for each 
patient where feasible.
    (c) In lieu of Form FD-1932 the holder of an approved new animal 
drug application may submit:
    (1) A computerized report if the information contained therein and 
the sequence in which it is presented are equivalent to that required by 
Form FD-1932 and the report is submitted in duplicate. Such reports will 
require initial approval by the Food and Drug Administration prior to 
use; and
    (2) Copies of reports of reactions appearing in the published 
scientific literature may be submitted.

[[Page 45]]

    (d) Forms FD-1932 and FD-2301, with instructions for their use, may 
be obtained from the Food and Drug Administration, Department of Health 
and Human Services, Center for Veterinary Medicine, 7500 Standish Pl., 
Rockville, MD 20855.

[40 FR 13807, Mar. 27, 1975, as amended at 41 FR 35844, Aug. 25, 1976; 
54 FR 18280, Apr. 28, 1989; 57 FR 6475, Feb. 25, 1992]

    Effective Date Note: At 68 FR 15365, Mar. 31, 2003, Sec.  510.302 
was removed, effective June 30, 2003.



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 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]



          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.



Sec.  510.455  New animal drug requirements regarding free-choice administration in feeds.

    (a) For the purpose of this section, free-choice administration of 
animal drugs in feeds involves feeds that are placed in feeding or 
grazing areas and are not intended to be consumed fully at a single 
feeding or to constitute the entire diet of the animal. Such methods of 
administering drugs include, but

[[Page 46]]

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 animal drugs. The manufacture of 
medicated free-choice feeds is subject to the current good manufacturing 
practice regulations for medicated feeds.
    (b) The Food and Drug Administration has concluded that there are 
questions about the safety and effectiveness of drugs when administered 
in free-choice feeds. Therefore, such methods of administration cause 
the drugs so administered to be new animal drugs, for which approved new 
animal drug applications (NADA's) are required. (See Sec.  510.3(i)). In 
addition, the exemption from the requirement of an approved medicated 
feed application provided in Sec.  558.4 of this chapter does not apply 
to any free-choice medicated feed.
    (c) An NADA or supplemental NADA for products for free-choice 
feeding submitted for approval under section 512(b) of the act shall 
provide for:
    (1) The manufacture of a finished product for the free-choice 
administration of a new animal drug. Such an approval will not provide a 
basis upon which an application can be approved under section 512(m) of 
the act; or
    (2) The manufacture of a Type A medicated article for use in the 
subsequent manufacture of a free-choice medicated feed. The approved 
NADA will provide a basis upon which an application can be approved 
under section 512(m) of the act. Data for a specific free-choice product 
may, if desired, be generated and submitted to the Food and Drug 
Administration by the manufacturer of the free-choice feed in the form 
of a master file which can be referenced in the NADA or supplemental 
NADA submitted by the new animal drug sponsor.
    (d) Approval of the NADA or supplemental NADA submitted under 
paragraph (c) of this section will be reflected in a regulation in part 
558 of this chapter published under section 512(i) of the act. The 
regulation will either state the formulation of the approved free-choice 
product or specify the specific free-choice administration products in 
which the drug is approved for use. If the approval is for a Type A 
medicated article, the regulation in part 558 of this chapter will 
indicate that each use of the Type A medicated article in a free-choice 
product must be the subject of an approved supplemental NADA.
    (e) An application submitted under section 512(m) of the act to 
provide for manufacture of a specific free-choice feed from an approved 
Type A medicated article will be approved if, in addition to the 
information required by the medicated feed application, it includes a 
reference to the exact formula of the product to be manufactured as 
follows:
    (1) The formula is the same as the one published in the new animal 
drug regulations; or
    (2) The data in a master file have been referenced in an NADA or 
supplemental NADA; and
    (3) Use of the Type A medicated article in the specific formulation 
has been approved on the basis that:
    (i) The formula is the same as the one for which acceptable data 
have been submitted in a master file by the medicated feed applicant; or
    (ii) The medicated feed applicant has written authority to reference 
a master file that has acceptable data for the formula in question.

[51 FR 19827, June 3, 1986, as amended at 67 FR 9586, Mar. 4, 2002]



    Subpart F--Animal Use Exemptions From Certification and Labeling 
                              Requirements



Sec.  510.515  Animal feeds bearing or containing new animal drugs subject to the provisions of section 512(n) of the act.

    Animal feeds that bear or contain penicillin, chlortetracycline, 
feed grade zinc bacitracin, and bacitracin methylene disalicylate, with 
or without added suitable nutritive ingredients are exempt from the 
certification requirements of section 512 of the act provided they are 
the subject of and in compliance with regulations for their use in this 
subchapter E, part 558 of this chapter, or any one of the paragraphs of 
this section:

[[Page 47]]

    (a) Where indicated in paragraph (b) of this section it is 
manufactured with or without one, but only one, of the following 
ingredients in a quantity, by weight of feed, as hereinafter indicated:
    (1) Arsanilic acid: Not less than 0.005 percent and not more than 
0.01 percent.
    (2) Sodium arsanilate: Not less than 0.005 percent and not more than 
0.01 percent.
    (3) 3-Nitro-4-hydroxyphenylarsonic acid: Not less than 0.0025 
percent and not more than 0.0075 percent except in chicken or turkey 
feed which shall contain not less than 0.0025 percent and not more than 
0.005 percent.
    (b) It is intended for use in any one of the following conditions 
set forth in this paragraph:
    (1) It is intended for use solely in the treatment of chronic 
respiratory disease (air-sac infection), infectious sinusitis, and blue 
comb (nonspecific infectious enteritis) in poultry and/or bacterial 
swine enteritis; its labeling bears adequate directions and warnings for 
such use; and it contains, per ton of feed, the equivalent of 100 grams 
of penicillin. When intended for uses specified in this paragraph, it 
may also contain, in the amount specified, one, but only one, of the 
ingredients prescribed by paragraph (a) of this section.
    (2) It is intended for use solely in the treatment of chronic 
respiratory disease (air-sac infection) and infectious sinusitis in 
poultry; its labeling bears adequate directions and warnings for such 
use; and it contains not less than 0.1 percent para-aminobenzoic acid or 
the sodium or potassium salt or para-aminobenzoic acid.
    (3)-(29) [Reserved]
    (c) It is intended for use as follows:

----------------------------------------------------------------------------------------------------------------
            Product                      Species                  Use levels             Indications for use
----------------------------------------------------------------------------------------------------------------
1. Nicarbazin.................  Chickens................  0.01 to 0.02 percent.....  For use in the prevention
                                ......do................  2.4 to 50 g/ton..........   of outbreaks of
                                                                                      coccidiosis in poultry
                                                                                      flocks; growth promotion
                                                                                      and feed efficiency.
2. Nicarbazin.................  ......do................  0.01 to 0.02 percent.....   Do.
  Bacitracin methylene          ......do................  4 to 50 g/ton............
   disalicylate.
3. Nicarbazin.................  ......do................  0.01 to 0.02 percent.....  For use as an aid in the
                                                                                      prevention of coccidiosis
                                                                                      in poultry flocks; growth
                                                                                      promotion and feed
                                                                                      efficiency; improving
                                                                                      pigmentation.
  Bacitracin methylene          ......do................  4 to 50 g/ton............
   disalicylate.
  3-Nitro-4-                    ......do................  0.0025 to 0.005 percent..
   hydroxyphenylarsonic acid.
4. Nicarbazin.................  ......do................  0.01 to 0.02 percent.....   Do.
  Procaine penicillin.........  ......do................  2.4 to 50 g/ton..........
  3-Nitro-4-                    ......do................  0.0025 to 0.005 percent..
   hydroxyphenylarsonic acid.
5. Chlortetracycline..........  Swine...................  10 to 50 g/ton...........  Enhancement of growth and
                                                                                      feed efficiency.
  Arsanilic acid..............  ......do................  0.005 to 0.01 percent....
----------------------------------------------------------------------------------------------------------------


[41 FR 8299, Feb. 25, 1976, as amended at 41 FR 11011, Mar. 15, 1976; 42 
FR 18614, Apr. 8, 1977; 47 FR 42102, Sept. 24, 1982; 47 FR 51563, Nov. 
16, 1982; 56 FR 41912, Aug. 23, 1991; 58 FR 30119, May 26, 1993; 61 FR 
35950, July 9, 1996]



              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

[[Page 48]]

labeler code is established pursuant to section 510 of the act.
    (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
                    Firm name and address                       labeler
                                                                 code
------------------------------------------------------------------------
Abbott Laboratories, North Chicago, IL 60064................      000074
ADM Alliance Nutrition, Inc., 1000 North 30th St., Quincy,        021930
 IL 62305-3115..............................................
ADM Animal Health & Nutrition Division, 1000 North 30th St.,      017519
 Box 1C, Quincy, IL 62305-3115..............................
Ag-Mark, Inc., P.O. Box 127, Teachey, NC 28464..............      024174
Agri Laboratories, Ltd., P.O. Box 3103, St. Joseph, MO 64503      057561
Agri-Tech, Inc., 4722 Broadway, Kansas City, MO 64112.......      017762
Akzo Nobel Surface Chemistry AB, Box 851, S-44485                 063765
 Stenungsund, Sweden........................................
Alaco, Inc., 1500 North Wilmot Rd., suite 290-C, Tucson, AZ       064146
 85712......................................................
Alpharma Inc., One Executive Drive, P.O. Box 1399, Fort Lee,      046573
 NJ 07024...................................................
Alstoe, Ltd., Animal Health, Granary Chambers, 37-39 Burton       062408
 St., Melton Mowbray, Leicestershire LE13 1AF, England......
Altana Inc., 60 Baylis Rd., Melville, NY 11747..............      025463
American Pharmaceuticals Partners, Inc., 2045 North Cornell       063323
 Ave., Melrose Park, IL 60160...............................
Anika Therapeutics Inc., 236 West Cummings Park, Woburn, MA       060865
 01801......................................................
Anthony Products Co., 5600 Peck Rd., Arcadia, CA 91006......      000864
Argent Laboratories, 8702 152d Ave. NE., Redmond, WA 98052..      051212
Ausa International, Inc., Rt. 8, P.O. Box 324-12, Tyler, TX       059521
 75703......................................................
Aventis Animal Nutrition, Inc., 3480 Preston Ridge Rd.,           011526
 suite 650, Alpharetta, GA 30005-8891.......................
Baxter Healthcare Corp., 95 Spring St., New Providence, NJ        010019
 07974......................................................
Bayer HealthCare LLC, Animal Health Division, P.O. Box 390,       000859
 Shawnee Mission, KS 66201..................................
Bertek Pharmaceuticals, Inc., 12720 Dairy Ashford, Sugar          062794
 Land, TX 77478.............................................
Biocraft Laboratories, Inc., 92 Route 46, Elmwood Park, NJ        000332
 07407......................................................
Bioniche Animal Health USA, Inc., 119 Rowe Rd., Athens, GA        064847
 30601......................................................
Bioproducts, Inc., 320 Springside Dr., Suite 300, Fairlawn,       051359
 OH 44333-2435..............................................
Biopure Corp., 11 Hurley St., Cambridge, MA 02141...........      063075
BioScience Division of Milk Specialties Co., 1902 Tennyson        032761
 Lane, Madison, WI 53704....................................
Boehringer Ingelheim Vetmedica, Inc., 2621 North Belt             000010
 Highway, St. Joseph, MO 64506-2002.........................
Chanelle Pharmaceuticals Manufacturing Ltd., Loughrea,            061651
 County Galway, Ireland.....................................
Chemdex, Inc., 12340 Santa Fe Dr., Lenexa, KS 66215.........      017287
Church & Dwight Co., Inc., 469 North Harrison St.,                010237
 Princeton, NJ 08543-5297...................................
Combe, Inc., 1101 Westchester Ave., White Plains, NY 10604..      011509
ConAgra Pet Products Co., 3902 Leavenworth St., Omaha, NE         021091
 68105......................................................
Contemporary Products, Inc., 3788 Elm Springs Rd.,                055462
 Springdale, AR 72764-6067..................................
Cooperative Research Farms, Box 69, Charlotteville, NY 12036      051267
Cross Vetpharm Group Ltd., Broomhill Rd., Tallaght, Dublin        061623
 24, Ireland................................................
Custom Feed Blenders Corp., 540 Hawkeye Ave., Fort Dodge, IA      046987
 50501......................................................
Custom Feed Services Corp., 2100 N. 13th St., Norfolk, NE         017473
 68701......................................................
Delmarva Laboratories, Inc., 1500 Huguenot Rd., suite 106,        059079
 Midlothian, VA 23113.......................................
ECO LLC, 8209 Hollister Ave., Las Vegas, NV 89131...........      066916
Elanco Animal Health, A Division of Eli Lilly & Co., Lilly        000986
 Corporate Center, Indianapolis, IN 46285...................
Endo Pharmaceuticals, Inc., 100 Painters Dr., Chadds Ford,        060951
 PA 19317...................................................
Eon Labs Manufacturing, Inc. 227-15 North Conduit Ave.,           000185
 Laurelton, NY 11413........................................
Evsco Pharmaceuticals, An Affiliate of IGI, Inc., Box 209,        017030
 Harding Hwy., Buena, NJ 08310..............................
Farmland Industries, Inc., Kansas City, MO 64116............      021676
Farnam Companies, Inc., 301 West Osborn, Phoenix, AZ 85013-       017135
 3928.......................................................
Feed Service Co., Inc., 303 Lundin Blvd., P.O. Box 698,           030841
 Mankato, MN 56001..........................................
John J. Ferrante, 11 Fairway Lane, Trumbull, CT 06611.......      058034
First Priority, Inc., 1585 Todd Farm Dr., Elgin, IL 60123...      058829
Fleming Laboratories, Inc., P.O. Box 34384, Charlotte, NC         015565
 28234......................................................
Fort Dodge Animal Health, A Division of American Cyanamid         053501
 Co., P.O. Box 1339, Fort Dodge, IA 50501...................
Fort Dodge Animal Health, Division of Wyeth, 500 Fifth St.        000856
 NW., Fort Dodge, IA 50501..................................
Furst-McNess Co., Freeport, IL 61032........................      010439
Gossett Nutrition, Inc., 1676 Cascade Dr., Marion, OH 43302.      050972
G. C. Hanford Manufacturing Co., P.O. Box 1017, Syracuse, NY      010515
 13201......................................................
Halocarbon Laboratories, Division of Halocarbon Products          012164
 Corp., 887 Kinderkamack Rd., P.O. Box 661, River Ridge, NJ
 07661......................................................
Happy Jack, Inc., Snow Hill, NC 28580.......................      023851
Hess & Clark, Inc., Seventh and Orange Sts., Ashland, OH          050749
 44805......................................................
IDEXX Pharmaceuticals, Inc., 4249-105 Piedmont Pkwy.,             065274
 Greensboro, NC 27410.......................................
I.M.S. Inc., 13619 Industrial Rd., Omaha, NE 68137..........      050639
IMPAX Laboratories, Inc., 30831 Huntwood Ave., Hayward, CA        000115
 94544......................................................
International Nutrition, Inc., 7706 `I' Plaza, Omaha, NE          043733
 68127......................................................
Intervet, Inc., P.O. Box 318, 405 State St., Millsboro, DE        057926
 19966......................................................
Ivy Laboratories, Div. of Ivy Animal Health, Inc., 8857 Bond      021641
 Street, Overland Park, KS 66214............................
J. C. Feed Mills, 1050 Sheffield, P.O. Box 224, Waterloo, IA      039741
 50704......................................................
Jorgensen Laboratories, Inc., 1450 North Van Buren Ave.,          045087
 Loveland, CO 80538.........................................

[[Page 49]]

 
K. C. Pharmacal, Inc., 8345 Melrose Dr., Lenexa, KS 66214...      038782
Kerber Milling Co., Box 152, 1817 E. Main St., Emmetsburg,        029341
 IA 50536...................................................
Lloyd, Inc., 604 W. Thomas Ave., Shenandoah, IA 51601.......      061690
Luitpold Pharmaceuticals, Inc., Animal Health Division,           010797
 Shirley, NY 11967..........................................
M & M Livestock Products Co., Eagle Grove, IA 50533.........      026282
Macleod Pharmaceuticals, Inc., 2600 Canton Ct., Fort              058711
 Collins, CO 80525..........................................
Marsam Pharmaceuticals, LLC, Bldg. 31, 24 Olney Ave., Cherry      000209
 Hill, NJ 08034.............................................
Medicis Dermatologics, Inc., 8125 North Hayden Rd.,               099207
 Scottsdale, AZ 85258.......................................
Med-Pharmex, Inc., 2727 Thompson Creek Rd., Pomona, CA 91767-     051259
 1861.......................................................
Merial Ltd., 3239 Satellite Blvd., Bldg. 500, Duluth, GA          050604
 30096-4640.................................................
Micro Beef Technologies LTD, P.O. Box 9262, Amarillo, TX          047126
 79105......................................................
Mid-Continent Agrimarketing, Inc., 8833 Quivira Rd.,              059620
 Overland Park, KS 66214....................................
Minrad, Inc., 836 Main St., 2d floor, Buffalo, NY 14202.....      060307
Monsanto Co., 800 North Lindbergh Blvd., St. Louis, MO 63167      059945
Natchez Animal Supply Co., 201 John R. Junkin Dr., Natchez,       049968
 MS 39120...................................................
Norbrook Laboratories, Ltd., Station Works, Newry BT35 6JP,       055529
 Northern Ireland...........................................
Norco Mills of Norfolk, Inc., P.O. Box 56, Norfolk, NE 68701      027190
North American Nutrition Companies, Inc., C.S. 5002, 6531         017790
 St., Rt. 503, Lewisburg, OH 45338..........................
Novartis Animal Health US, Inc., 3200 Northline Ave., suite       058198
 300, Greensboro, NC 27408..................................
Nutra-Blend Corp., P.O. Box 485, Neosho, MO 64850...........      050568
NutriBasics Co., North Highway 71, P.O. Box 1014, WIllmar,        053740
 MN 56201...................................................
Nylos Trading Co., Inc., P.O. Box 2, Route 202, Pomona, NY        027454
 10970......................................................
Orion Corp., Orionintie 1, 02200 Espoo, Finland.............      052483
Orphan Medical, Inc., 13911 Ridgedale Dr., Suite 475,             062161
 Minnetonka, MN 55305.......................................
OXIS International, Inc., 6040 N. Cutter Circle, Suite 317,       024991
 Portland, OR 97217-3935....................................
Peavey Co., 730 Second Ave. South, Minneapolis, MN 55402....      028459
Pegasus Laboratories, Inc., 8809 Ely Rd., Pensacola, FL           055246
 32514......................................................
Pennfield Oil Co., 14040 Industrial Rd., Omaha, NE 68144....      053389
Peptech Animal Health Pty, Ltd., 35-41 Waterloo Rd., North        064288
 Ryde, New South Wales 2113, Australia......................
Pfizer, Inc., 235 East 42d St., New York, NY 10017..........      000069
Pharmacia & Upjohn Co., 7000 Portage Rd., Kalamazoo, MI           000009
 49001-0199.................................................
Phibro Animal Health, 710 Rt. 46 East, suite 401, Fairfield,      066104
 NJ 07004...................................................
Phoenix Pharmaceutical, Inc., 4621 Easton Rd., P.O. Box 6457      057319
 Farleigh Station, St. Joseph, MO 64506-0457................
Phoenix Scientific, Inc., 3915 South 48th St. Terrace, St.        059130
 Joseph, MO 64503...........................................
Planalquimica Industrial Ltda., Rua das Magnolias nr. 2405,       060728
 Jardim das Bandeiras, CEP 13053-120, Campinas, Sao Paulo,
 Brazil.....................................................
Pliva d.d., Ulica grada Vukovara 49, 10000 Zagreb, Croatia..      011722
PM Resources, Inc., 13001 St. Charles Rock Rd., Bridgeton,        060594
 MO 63044...................................................
Purina Mills, Inc., P.O. Box 66812, St. Louis, MO 63166-6812      017800
Quali-Tech Products, Inc., 318 Lake Hazeltine Drive, Chaska,      016968
 MN 55318...................................................
Rhodia Limited, P.O. Box 46, St. Andrews Rd., Avonmouth,          059258
 Bristol BS11 9YF, England, UK..............................
RMS Laboratories, Inc., 1903 East First St., Vidalia, GA          067292
 30474......................................................
Roche Vitamins, Inc., 45 Waterview Blvd., Parsippany, NJ          063238
 07054-1298.................................................
RSR Laboratories, Inc., 501 Fifth St., Bristol, TN 37620....      058670
R. P. Scherer North America, P.O. Box 5600, Clearwater, FL        011014
 33518......................................................
Schering-Plough Animal Health Corp., 1095 Morris Ave.,            000061
 Union, NJ 07083............................................
G. D. Searle LLC, Pharmacia Corp., 4901 Searle Pkwy.,             000014
 Skokie, IL 60077...........................................
Seeco Inc., Box 1014, North Highway 71, Willmar, MN 56201...      011749
Sioux Biochemical, Inc., 204 Third St. NW., Sioux Center, IA      063112
 51250......................................................
South St. Paul Feeds, Inc., 500 Farwell Ave., South St.           001800
 Paul, MN 55075.............................................
Southern Micro-Blenders, Inc., 3801 North Hawthorne St.,          049685
 Chattanooga, TN 37406......................................
Springfield Milling Corp., Vigorena Feeds, Springfield, MN        035955
 56087......................................................
Squire Laboratories, Inc., 100 Mill St., Revere, MA 02151...      017153
Steris Laboratories, Inc., 620 North 51st Ave., Phoenix, AZ       000402
 85043-4705.................................................
Summit Hill Laboratories, P.O. Box 535, Navesink, NJ 07752..      037990
Sweetlix, LLC, 175 South Main St., suite 150, Salt Lake           036904
 City, UT 84111.............................................
Teva Pharmaceuticals USA, 650 Cathill Rd., Sellersville, PA       000093
 18960......................................................
Texas Vitamin Co., P.O. Box 18417, 10695 Aledo St., Dallas,       000842
 TX 57218...................................................
Triple ``F'', Inc., 10104 Douglas Ave., Des Moines, IA 50322      011490
United Vaccines, A Harlan Sprague Dawley, Inc., Co., P.O.         058639
 Box 4220, Madison, WI 53711................................
Vetem, S.p.A., Viale E. Bezzi 24, 20146 Milano, Italy.......      055882
Veterinary Laboratories, Inc., 12340 Santa Fe Dr., Lenexa,        000857
 KS 66215...................................................
Veterinary Research Associates, Inc., 2817 West Country Rd.       064408
 54G, Fort Collins, CO 80524................................
Veterinary Service, Inc., 416 North Jefferson St., P.O. Box       033008
 2467, Modesto, CA 95354....................................
Veterinary Specialties Inc., 387 North Valley Ct.,                062925
 Barrington, IL 60010.......................................
Vetoquinol N.-A., Inc., 2000 chemin Georges, Lavaltrie (PQ),      059320
 Canada, J0K 1H0............................................
Virbac AH, Inc., 3200 Meacham Blvd., Ft. Worth, TX 76137....      051311
Walco International, Inc., 15 West Putnam, Porterville, CA        049185
 93257
Waterloo Mills Co., 2050 Mitchell Ave., Waterloo, IA 50704..      017139

[[Page 50]]

 
Wayne Feed Division, Continental Grain Co., P.O. Box 459,         034936
 Libertyville, IL 60048.....................................
Webel Feeds, Inc., R.R. 3, Pittsfield, IL 62363.............      035098
Wellmark International, 1100 East Woodfield Rd., suite 500,       011536
 Schaumburg, IL 60173.......................................
Wendt Laboratories , Inc., 100 Nancy Dr., Belle Plaine, MN        015579
 56011......................................................
West Agro, Inc., 11100 N. Congress Ave., Kansas City, MO          033392
 64153......................................................
Western Chemical, Inc., 1269 Lattimore Rd., Ferndale, WA          050378
 98248......................................................
Wildlife Laboratories, Inc., 1401 Duff Dr., Suite 600, Fort       053923
 Collins, CO 80524..........................................
Wyeth Laboratories, Division American Home Products Corp.,        000008
 P.O. Box 8299, Philadelphia, PA 19101......................
Yoder Feed, Division of Yoder, Inc., Kalona, IA 52247.......      035369
Zema Corp., P.O. Box 12803, Research Triangle Park, Durham,       050906
 NC 27709...................................................
------------------------------------------------------------------------


                    (2) Numerical Listing of Sponsors
------------------------------------------------------------------------
         Drug labeler code                  Firm name and address
------------------------------------------------------------------------
000008.............................  Wyeth Laboratories, Division
                                      American Home Products Corp., P.O.
                                      Box 8299, Philadelphia, PA 19101.
000009.............................  Pharmacia & Upjohn Co., 7000
                                      Portage Rd., Kalamazoo, MI 49001-
                                      0199.
000010.............................  Boehringer Ingelheim Vetmedica,
                                      Inc., 2621 North Belt Highway, St.
                                      Joseph, MO 64506-2002.
000014.............................  G. D. Searle LLC, Pharmacia Corp.,
                                      4901 Searle Pkwy., Skokie, IL
                                      60077.
000061.............................  Schering-Plough Animal Health
                                      Corp., 1095 Morris Ave., Union, NJ
                                      07083.
000069.............................  Pfizer, Inc., 235 East 42d St., New
                                      York, NY 10017.
000074.............................  Abbott Laboratories, North Chicago,
                                      IL 60064.
000093.............................  Teva Pharmaceuticals USA, 650
                                      Cathill Rd., Sellersville, PA
                                      18960.
000115.............................  IMPAX Laboratories, Inc., 30831
                                      Huntwood Ave., Hayward, CA 94544.
000185.............................  Eon Labs Manufacturing, Inc., 227-
                                      15 North Conduit Ave., Laurelton,
                                      NY 11413.
000209.............................  Marsam Pharmaceuticals, LLC, Bldg.
                                      31, 24 Olney Ave., Cherry Hill, NJ
                                      08034.
000332.............................  Biocraft Laboratories, Inc., 92
                                      Route 46, Elmwood Park, NJ 07407.
000402.............................  Steris Laboratories, Inc., 620
                                      North 51st Ave., Phoenix, AZ 85043-
                                      4705.
000842.............................  Texas Vitamin Co., P.O. Box 18417,
                                      10695 Aledo St., Dallas, TX 57218.
000856.............................  Fort Dodge Animal Health, Division
                                      of Wyeth, 500 Fifth St. NW., Fort
                                      Dodge, IA 50501.
000857.............................  Veterinary Laboratories, Inc.,
                                      12340 Santa Fe Dr., Lenexa, KS
                                      66215.
000859.............................  Bayer HealthCare LLC, Animal Health
                                      Division, P.O. Box 390, Shawnee
                                      Mission, KS 66201
000864.............................  Anthony Products Co., 5600 Peck
                                      Rd., Arcadia, CA 91006.
000986.............................  Elanco Animal Health, A Division of
                                      Eli Lilly & Co., Lilly Corporate
                                      Center, Indianapolis, IN 46285.
001800.............................  South St. Paul Feeds, Inc., 500
                                      Farwell Ave., South St. Paul, MN
                                      55075.
010019.............................  Baxter Healthcare Corp., 95 Spring
                                      St., New Providence, NJ 07974.
010237.............................  Church & Dwight Co., Inc., 469
                                      North Harrison St., Princeton, NJ
                                      08543-5297.
010439.............................  Furst-McNess Co., Freeport, IL
                                      61032.
010515.............................  G. C. Hanford Manufacturing Co.,
                                      P.O. Box 1017, Syracuse, NY 13201.
010797.............................  Luitpold Pharmaceuticals, Inc.,
                                      Animal Health Division, Shirley,
                                      NY 11967.
011014.............................  R. P. Scherer North America, P.O.
                                      Box 5600, Clearwater, FL 33518.
011490.............................  Triple ``F'', Inc., 10104 Douglas
                                      Ave., Des Moines, IA 50322.
011509.............................  Combe, Inc., 1101 Westchester Ave.,
                                      White Plains, NY 10604.
011526.............................  Aventis Animal Nutrition, Inc.,
                                      3480 Preston Ridge Rd., suite 650,
                                      Alpharetta, GA 30005-8891.
011536.............................  Wellmark International, 1100 East
                                      Woodfield Rd., suite 500,
                                      Schaumburg, IL 60173.
011722.............................  Pliva d.d., Ulica grada Vukovara
                                      49, 10000 Zagreb, Croatia
011749.............................  Seeco Inc., Box 1014, North Highway
                                      71, Willmar, MN 56201.
012164.............................  Halocarbon Laboratories, Division
                                      of Halocarbon Products Corp., 887
                                      Kinderkamack Rd., P.O. Box 661,
                                      River Ridge, NJ 07661.
015565.............................  Fleming Laboratories, Inc., P.O.
                                      Box 34384, Charlotte, NC 28234.
015579.............................  Wendt Laboratories, Inc., 100 Nancy
                                      Dr., Belle Plaine, MN 56011.
016968.............................  Quali-Tech Products, Inc., 318 Lake
                                      Hazeltine Dr., Chaska, MN 55318.
017030.............................  Evsco Pharmaceuticals, An Affiliate
                                      of IGI, Inc., Box 209, Harding
                                      Hwy., Buena, NJ 08310.
017135.............................  Farnam Companies, Inc., 301 West
                                      Osborn, Phoenix, AZ 85013-3928.
017139.............................  Waterloo Mills Co., 2050 Mitchell
                                      Ave., Waterloo, IA 50704.
017153.............................  Squire Laboratories, Inc., 100 Mill
                                      St., Revere, MA 02151.
017287.............................  Chemdex, Inc., 12340 Santa Fe Dr.,
                                      Lenexa, KS 66215.
017473.............................  Custom Feed Services Corp., 2100 N.
                                      13th St., Norfolk, NE 68701.
017519.............................  ADM Animal Health & Nutrition
                                      Division, 1000 North 30th St., Box
                                      1C, Quincy, IL 62305-3115
017762.............................  Agri-Tech, Inc., 4722 Broadway,
                                      Kansas City, MO 64112.
017790.............................  North American Nutrition Companies,
                                      Inc., C.S. 5002, 6531 St., Rt.
                                      503, Lewisburg, OH 45338.
017800.............................  Purina Mills, Inc., P.O. Box 66812,
                                      St. Louis, MO 63166-6812.
021091.............................  ConAgra Pet Products Co., 3902
                                      Leavenworth St., Omaha, NE 68105.
021641.............................  Ivy Laboratories, Div. of Ivy
                                      Animal Health, Inc., 8857 Bond
                                      Street, Overland Park, KS 66214.
021676.............................  Farmland Industries, Inc., Kansas
                                      City, MO 64116.
021930.............................  ADM Alliance Nutrition, Inc., 1000
                                      North 30th St., Quincy, IL 62305-
                                      3115
023851.............................  Happy Jack, Inc., Snow Hill, NC
                                      28580.

[[Page 51]]

 
024174.............................  Ag-Mark, Inc., P.O. Box 127,
                                      Teachey, NC 28464.
024991.............................  OXIS International, Inc., 6040 N.
                                      Cutter Circle, Suite 317 Portland,
                                      OR 97217-3935.
025463.............................  Altana Inc., 60 Baylis Rd.,
                                      Melville, NY 11747.
026282.............................  M & M Livestock Products Co., Eagle
                                      Grove, IA 50533.
027190.............................  Norco Mills of Norfolk, Inc., P.O.
                                      Box 56, Norfolk, NE 68701.
027454.............................  Nylos Trading Co., Inc., P.O. Box
                                      2, Route 202, Pomona, NY 10970.
028459.............................  Peavey Co., 730 Second Ave. South,
                                      Minneapolis, MN 55402.
029341.............................  Kerber Milling Co., Box 152, 1817
                                      E. Main St., Emmetsburg, IA 50536.
030841.............................  Feed Service Co., Inc., 303 Lundin
                                      Blvd., P.O. Box 698, Mankato, MN
                                      56001.
032761.............................  BioScience Division of Milk
                                      Specialties Co., 1902 Tennyson
                                      Lane, Madison, WI 53704
033008.............................  Veterinary Service, Inc., 416 North
                                      Jefferson St., P.O. Box 2467,
                                      Modesto, CA 95354.
033392.............................  West Agro, Inc., 11100 N. Congress
                                      Ave., Kansas City, MO 64153.
034936.............................  Wayne Feed Division, Continental
                                      Grain Co., P.O. Box 459,
                                      Libertyville, IL 60048.
035098.............................  Webel Feeds, Inc., R.R. 3,
                                      Pittsfield, IL 62363.
035369.............................  Yoder Feed, Division of Yoder,
                                      Inc., Kalona, IA 52247.
035955.............................  Springfield Milling Corp., Vigorena
                                      Feeds, Springfield, MN 56087.
036904.............................  Sweetlix, LLC, 175 South Main St.,
                                      suite 150, Salt Lake City, UT
                                      84111.
037990.............................  Summit Hill Laboratories, P.O. Box
                                      535, Navesink, NJ 07752.
038782.............................  K. C. Pharmacal, Inc., 8345 Melrose
                                      Dr., Lenexa, KS 66214.
039741.............................  J. C. Feed Mills, 1050 Sheffield,
                                      P.O. Box 224, Waterloo, IA 50704.
043733.............................  International Nutrition, Inc., 7706
                                      `I' Plaza, Omaha, NE 68127
045087.............................  Jorgensen Laboratories, Inc., 1450
                                      North Van Buren Ave., Loveland, CO
                                      80538.
046573.............................  Alpharma Inc., One Executive Drive,
                                      P.O. Box 1399, Fort Lee, NJ 07024.
046987.............................  Custom Feed Blenders Corp., 540
                                      Hawkeye Ave., Fort Dodge, IA
                                      50501.
047126.............................  Micro Beef Technologies LTD, P.O.
                                      Box 9262, Amarillo, TX 79105.
049185.............................  Walco International, Inc., 15 West
                                      Putnam, Porterville, CA 93257.
049685.............................  Southern Micro-Blenders, Inc., 3801
                                      North Hawthorne St., Chattanooga,
                                      TN 37406.
049968.............................  Natchez Animal Supply Co., 201 John
                                      R. Junkin Dr., Natchez, MS 39120.
050378.............................  Western Chemical, Inc., 1269
                                      Lattimore Rd., Ferndale, WA 98248.
050568.............................  Nutra-Blend Corp., P.O. Box 485,
                                      Neosho, MO 64850.
050604.............................  Merial Ltd., 3239 Satellite Blvd.,
                                      Bldg. 500, Duluth, GA 30096-4640.
050639.............................  I.M.S. Inc., 13619 Industrial Rd.,
                                      Omaha, NE 68137.
050749.............................  Hess & Clark, Inc., Seventh and
                                      Orange Sts., Ashland, OH 44805.
050906.............................  Zema Corp., P.O. Box 12803,
                                      Research Triangle Park, Durham, NC
                                      27709.
050972.............................  Gossett Nutrition, Inc., 1676
                                      Cascade Dr., Marion, OH 43302.
051212.............................  Argent Laboratories, 8702 152d Ave.
                                      NE., Redmond, WA 98052.
051259.............................  Med-Pharmex, Inc., 2727 Thompson
                                      Creek Rd., Pomona, CA 91767-1861.
051267.............................  Cooperative Research Farms, Box 69,
                                      Charlotteville, NY 12036.
051311.............................  Virbac AH, Inc., 3200 Meacham
                                      Blvd., Ft. Worth, TX 76137.
051359.............................  Bioproducts, Inc., 320 Springside
                                      Dr., Suite 300, Fairlawn, OH
                                      44141.
052483.............................  Orion Corp., Orionintie 1, 02200
                                      Espoo, Finland.
053389.............................  Pennfield Oil Co., 14040 Industrial
                                      Rd., Omaha, NE 68144.
053501.............................  Fort Dodge Animal Health, A
                                      Division of American Cyanamid Co.,
                                      P.O. Box 1339, Fort Dodge, IA
                                      50501.
053740.............................  NutriBasics Co., North Highway 71,
                                      P.O. Box 1014, WIllmar, MN 56201.
053923.............................  Wildlife Laboratories, Inc., 1401
                                      Duff Dr., Suite 600, Fort Collins,
                                      CO 80524.
055246.............................  Pegasus Laboratories, Inc., 8809
                                      Ely Rd., Pensacola, FL 32514.
055462.............................  Contemporary Products, Inc., 3788
                                      Elm Springs Rd., Springdale, AR
                                      72764-6067.
055529.............................  Norbrook Laboratories, Ltd.,
                                      Station Works, Newry BT35 6JP,
                                      Northern Ireland.
055882.............................  Vetem, S.p.A., Viale E. Bezzi 24,
                                      20146 Milano, Italy.
057319.............................  Phoenix Pharmaceutical, Inc., 4621
                                      Easton Rd., P.O. Box 6457 Farleigh
                                      Station, St. Joseph, MO 64506-
                                      0457.
057561.............................  Agri Laboratories, Ltd., P.O. Box
                                      3103, St. Joseph, MO 64503.
057926.............................  Intervet, Inc., P.O. Box 318, 405
                                      State St., Millsboro, DE 19966.
058034.............................  John J. Ferrante, 11 Fairway Lane,
                                      Trumbull, CT 06611.
058198.............................  Novartis Animal Health US, Inc.,
                                      3200 Northline Ave., suite 300,
                                      Greensboro, NC 27408.
058639.............................  United Vaccines, A Harlan Sprague
                                      Dawley, Inc., Co., P.O. Box 4220,
                                      Madison, WI 53711.
058670.............................  RSR Laboratories, Inc., 501 Fifth
                                      St., Bristol, TN 37620.
058711.............................  Macleod Pharmaceuticals, Inc., 2600
                                      Canton Ct., Fort Collins, CO
                                      80525.
058829.............................  First Priority, Inc., 1585 Todd
                                      Farm Dr., Elgin, IL 60123.
059079.............................  Delmarva Laboratories, Inc., 1500
                                      Huguenot Rd., suite 106,
                                      Midlothian, VA 23113
059130.............................  Phoenix Scientific, Inc., 3915
                                      South 48th St. Terrace, St.
                                      Joseph, MO 64503
059258.............................  Rhodia Limited, P.O. Box 46, St.
                                      Andrews Rd., Avonmouth, Bristol
                                      BS11 9YF, England, UK.
059320.............................  Vetoquinol N.-A., Inc., 2000 chemin
                                      Georges, Lavaltrie (PQ), Canada,
                                      J0K 1H0
059945.............................  Monsanto Co., 800 North Lindbergh
                                      Blvd., St. Louis, MO 63167.
059521.............................  Ausa International, Inc., Rt. 8,
                                      P.O. Box 324-12, Tyler, TX 75703.
059620.............................  Mid-Continent Agrimarketing, Inc.,
                                      8833 Quivira Rd., Overland Park,
                                      KS 66214.Blvd., St. Louis, MO
                                      63167.

[[Page 52]]

 
060307.............................  Minrad, Inc., 836 Main St., 2d
                                      floor, Buffalo, NY 14202.
060594.............................  PM Resources, Inc., 13001 St.
                                      Charles Rock Rd., Bridgeton, MO
                                      63044.
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.
060951.............................  Endo Pharmaceuticals, Inc., 100
                                      Painters Dr., Chadds Ford, PA
                                      19317.
061623.............................  Cross Vetpharm Group Ltd.,
                                      Broomhill Rd., Tallaght, Dublin
                                      24, Ireland.
061651.............................  Chanelle Pharmaceuticals
                                      Manufacturing Ltd., Loughrea,
                                      County Galway, Ireland.
061690.............................  Lloyd, Inc., 604 W. Thomas Ave.,
                                      Shenandoah, IA 51601.
062161.............................  Orphan Medical, Inc., 13911
                                      Ridgedale Dr., Suite 475,
                                      Minnetonka, MN 55305.
062408.............................  Alstoe, Ltd., Animal Health,
                                      Granary Chambers, 37-39 Burton
                                      St., Melton Mowbray,
                                      Leicestershire LE13 1AF, England.
062794.............................  Bertek Pharmaceuticals, Inc., 12720
                                      Dairy Ashford, Sugar Land, TX
                                      77478
062925.............................  Veterinary Specialties Inc., 387
                                      North Valley Ct., Barrington, Il
                                      60010.
063075.............................  Biopure Corp., 11 Hurley St.,
                                      Cambridge, MA 02141.
063112.............................  Sioux Biochemical, Inc., 204 Third
                                      St. NW., Sioux Center, IA 51250.
063238.............................  Roche Vitamins, Inc., 45 Waterview
                                      Blvd., Parsippany, NJ 07054-1298.
063323.............................  American Pharmaceuticals Partners,
                                      Inc., 2045 North Cornell Ave.,
                                      Melrose Park, IL 60160.
063765.............................  Akzo Nobel Surface Chemistry AB,
                                      Box 851, S-44485 Stenungsund,
                                      Sweden.
064146.............................  Alaco, Inc., 1500 North Wilmot Rd.,
                                      suite 290-C, Tucson, AZ 85712.
064288.............................  Peptech Animal Health Pty, Ltd., 35-
                                      41 Waterloo Rd., North Ryde, New
                                      South Wales 2113, Australia.
064408.............................  Veterinary Research Associates,
                                      Inc., 2817 West Country Rd. 54G,
                                      Fort Collins, CO 80524
064847.............................  Bioniche Animal Health USA, Inc.,
                                      119 Rowe Rd., Athens, GA 30601
065274.............................  IDEXX Pharmaceuticals, Inc., 4249-
                                      105 Piedmont Pkwy., Greensboro, NC
                                      27410
066104.............................  Phibro Animal Health, 710 Rt. 46
                                      East, suite 401, Fairfield, NJ
                                      07004
066916.............................  ECO LLC, 8209 Hollister Ave., Las
                                      Vegas, NV 89131
067292.............................  RMS Laboratories, Inc., 1903 East
                                      First St., Vidalia, GA 30474
099207.............................  Medicis Dermatologics, Inc., 8125
                                      North Hayden Rd., Scottsdale, AZ
                                      85258
------------------------------------------------------------------------


[40 FR 13807, Mar. 27, 1975]

    Editorial Note: 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 on GPO Access.



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




    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 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,

[[Page 53]]

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 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 
the Food and Drug Administration 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.

[[Page 54]]

    (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 the Food and Drug Administration pursuant to part 16 of 
this chapter.
    (6) On written request of the Food and Drug Administration, 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 the Food and Drug Administration 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.

[[Page 55]]

    (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 the Food and Drug Administration 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) Withdrawal of eligibility to receive investigational-use new 
animal drugs. (1) Whenever the Food and Drug Administration has 
information indicating that an investigator has repeatedly or 
deliberately failed to comply with the conditions of these exempting 
regulations or has submitted false information either to the sponsor of 
the investigation or in any required report, the Center for Veterinary 
Medicine will furnish the investigator written notice of the matter 
complained of in general terms and offer him an opportunity to explain 
the matter in an informal conference and/or in writing. If an 
explanation is offered but not accepted by the Center for Veterinary 
Medicine, the investigator shall have an opportunity for a regulatory 
hearing before the Food and Drug Administration pursuant to part 16 of 
this chapter on the question of whether the investigator is entitled to 
receive investigational new animal drugs.
    (2) If, after evaluating all available information, including any 
explanation presented by the investigator, the Commissioner determines 
that the investigator has repeatedly or deliberately failed to comply 
with the conditions of the exempting regulations in this section or has 
repeatedly or deliberately submitted false information to the sponsor of 
an investigation, the Commissioner will notify the investigator and the 
sponsor of any investigation in which he has been named as a participant 
that the investigator is not entitled to receive investigational use new 
animal drugs with a statement of the basis for such determination.
    (3) Each ``Notice of Claimed Investigational Exemption for a New 
Animal Drug'' and each approved new animal drug application containing 
data reported by an investigator who has been determined to be 
ineligible to receive investigational-use new animal drugs will be 
examined to determine whether he has submitted unreliable data that are 
essential to the continuation of the investigation or essential to the 
approval of any new animal drug application.
    (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, he shall first notify the 
sponsor, who shall have an opportunity for a regulatory hearing before 
the Food and Drug Administration pursuant to part 16 of this chapter on 
whether the exemption should be terminated. If a danger to the public 
health exists, however, he shall terminate the exemption forthwith and 
notify the sponsor of the termination. In such event the sponsor shall 
have an opportunity for a regulatory hearing before the Food and Drug 
Administration pursuant to part 16 (see 42 FR 15675, March 22, 1977) of 
this chapter on the question of whether the exemption should be 
reinstated.
    (5) If the Commissioner determines, after the unreliable data 
submitted by the investigator are eliminated from consideration, that 
the data remaining are such that a new animal drug application would not 
have been approved, he will proceed to withdraw approval of the 
application in accordance with section 512(e) of the act.

[[Page 56]]

    (6) An investigator who has been determined to be ineligible may be 
reinstated as eligible to receive investigational-use new animal drugs 
when the Commissioner determines that he has presented adequate 
assurance that he will employ such new animal drugs solely in compliance 
with the exempting regulations in this section for investigational-use 
new animal drugs.
    (d) Termination of exemption. If the Commissioner finds that:
    (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 the Food and Drug 
Administration 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 the Food and Drug Administration.
    (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.

[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]



PART 514--NEW ANIMAL DRUG APPLICATIONS--Table of Contents




                      Subpart A--General Provisions

Sec.
514.1 Applications.
514.3 Definitions.
514.4 Substantial evidence.
514.6 Amended applications.
514.7 Withdrawal of applications without prejudice.
514.8 Supplemental new animal drug applications.
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.
514.100 Evaluation and comment on applications.
514.105 Approval of applications.
514.106 Approval of supplemental applications.
514.110 Reasons for refusing to file applications.

[[Page 57]]

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 Contents of notice of opportunity for a hearing.
514.201 Procedures for hearings.

Subparts D--E [Reserved]

                       Subpart F--Judicial Review

514.235 Judicial review.

    Authority: 21 U.S.C. 351, 352, 360b, 371, 379e, 381.

    Effective Date Note: At 68 FR 15365, Mar. 31, 2003, the authority 
for part 514 was revised, effective June 30, 2003. For the convenience 
of the user, the revised text is set forth as follows:

  

    Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 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 described in paragraph (b) of this section. 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.
    (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:
    (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.

[[Page 58]]

    (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:
    (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.

[[Page 59]]

    (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, 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

[[Page 60]]

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 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

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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 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

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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 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

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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 the format described under Sec.  
558.6(a)(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 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

[[Page 64]]

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.
    (d) Minor use applications. Applications for minor use new animal 
drugs:
    (1) Definitions. For the purpose of this section:
    (i) Minor use means the use of: (a) New animal drugs in minor animal 
species, or (b) new animal drugs in any animal species for the control 
of a disease that (1) occurs infrequently or (2) occurs in limited 
geographic areas.
    (ii) Minor species means animals other than cattle, horses, swine, 
chickens, turkeys, dogs, and cats.
    (2) Animal safety, effectiveness, human food safety, and 
environmental considerations. Guidance documents for the preparation and 
submission of data to satisfy the requirements of section 512 of the act 
regarding animal safety, effectiveness, human food safety, and 
environmental considerations for new animal drugs intended for a minor 
use (as defined in paragraph (d)(1)(i) of this section) are available 
from the Industry Information Staff (HFV-11), Center for Veterinary 
Medicine, Food and Drug Administration, 7500 Standish Pl., Rockville, MD 
20855.
    (i) Animal safety and effectiveness. Where the guidance documents do 
not specifically provide for a particular minor use, the Center for 
Veterinary Medicine, upon request, will advise interested persons on the 
effectiveness and animal safety data regarding the minor use that will 
be needed to satisfy the requirements of section 512 of the act. Where 
scientifically appropriate, the Center for Veterinary Medicine will 
allow the use of animal models and the extrapolation of data from a 
major species to a minor species to satisfy the requirements of the act.
    (ii) Human food safety and environmental considerations. These 
guidance documents do not specifically provide for a particular minor 
use. Therefore, the Center for Veterinary Medicine will, upon request, 
advise interested persons of the data that will be needed. Where 
scientifically appropriate, the Center for Veterinary Medicine will 
allow the extrapolation of data from a major species to a minor species 
to satisfy the requirements of the act.

[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 on GPO Access.



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,

[[Page 65]]

after appropriate adjustment for drug exposure.
    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.
    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]

    Effective Date Note: At 68 FR 15365, Mar. 31, 2003, Sec.  514.3 was 
added, effective June 30, 2003.



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 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

[[Page 66]]

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 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

[[Page 67]]

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.  514.6  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  Supplemental new animal drug applications.

    (a)(1) After a new animal drug application is approved, a 
supplemental new animal drug application may propose changes. A 
supplemental application may omit statements made in the approved 
application concerning which no change is proposed. Each supplemental 
application shall include up-to-date reports of any of the kinds of 
information required by Sec.  510.300(a) of this chapter that has not 
previously been submitted. A supplemental application shall be 
accompanied by 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.
    (2) A supplemental new animal drug application shall be submitted 
for any change beyond the variations provided for in the application, 
including changes in the scale of production such as from pilot-plant to 
production batch, that may alter the conditions of use, the labeling, 
safety, effectiveness, identity, strength, quality, or purity of the new 
animal drug, or the adequacy of the manufacturing methods, facilities, 
or controls to preserve them.

[[Page 68]]

    (3) 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:
    (i) 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
    (ii) Any other parts of the labeling are consistent with and not 
contrary to such approved or permitted labeling.
    (4) The supplemental application shall be submitted as follows. A 
communication proposing a change in a new animal drug application should 
provide for any one of the following kinds of changes:
    (i) Revision in labeling, such as updating information pertaining to 
effects, dosages, and side effects and contraindications, which includes 
information headed ``side effects,'' ``warnings,'' ``precautions,'' and 
``contraindications.''
    (ii) Addition of claim.
    (iii) Revision in manufacturing or control procedures; for example, 
changes in components, composition, method of manufacture, analytical 
control procedures, package or tablet size, etc.
    (iv) Change in manufacturing facilities.
    (v) Provision for outside firm to participate in the preparation, 
distribution, or packaging of a new animal drug (new distributor, 
packer, supplier, manufacturer, etc.); one firm per submission.

Any number of changes may be submitted at any one time; but if they fall 
into different categories as listed in paragraphs (a)(4) (i) through (v) 
of this section, the proposed changes should be covered by separate 
communications. Where, however, a change necessitates an overlap in 
categories, it should be submitted in a single communication. For 
example, a change in tablet potency would require other changes such as 
in components, composition, and labeling and should be submitted in a 
single communication.
    (5) The following kinds of changes may be placed into effect without 
the approval of a supplemental application, if such change is fully 
described in the next periodic report required under Sec.  510.300(b)(4) 
of this chapter or, when such a report is not required, in a written 
communication to the Food and Drug Administration within 60 days of the 
effective date of the change (this does not apply to a change proposed 
because of any mixup or any bacteriological or 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 its specifications):
    (i) A different container size for solid oral dosage forms where 
container and closure are of the same materials as those provided for in 
the approved application.
    (ii) Change in personnel not involving new facilities.
    (iii) Change in equipment that does not alter the method of 
manufacture of a new animal drug.
    (iv) Change from one commercial batch size to another without any 
change in manufacturing procedure.
    (v) Change to more stringent specification without altering the 
method described in the approved application.
    (vi) Inclusion of additional specifications and methods without 
deletion of those described in the approved application.
    (vii) Alteration of specifications or methods for inactive 
ingredients to bring them into compliance with new or revised 
specifications or methods in an official compendium.
    (viii) Initiation of a product identification coding system.
    (ix) Addition to labeling of a reasonable expiration date where none 
was previously used, with related conditions of drug storage when 
appropriate, except when evidence shows that a significant deterioration 
of the drug under marketing conditions has occurred which necessitates 
the immediate submission of a report under Sec.  510.300(b)(1) of this 
chapter. The report or written communication describing such change in 
labeling should include stability data justifying the expiration date 
and recommended conditions of storage.
    (x) Change from paper labels to direct printing on glass or other 
kinds of immediate containers without a change in text.

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    (6) Approval of a supplemental new animal drug application will not 
be required to provide for an additional distributor to distribute a 
drug which is the subject of an approved new animal drug application if 
the conditions described below are met prior to putting such a change 
into effect. An order may issue refusing approval if any condition is 
not met or if any of the reasons for refusing or withdrawing approval, 
as stated in section 512(d) and (e) of the act or Sec.  514.110 applies. 
For the purposes of maintaining records and making reports under the 
requirements of Sec.  510.300 of this chapter, a distributor provided 
for under this section shall be considered an applicant within the 
meaning of Sec.  510.300(b) of this chapter. Said conditions are:
    (i) A supplemental application is furnished to the Food and Drug 
Administration to provide for a designated distributor.
    (ii) There are no changes from the conditions of the approved 
application except for a different and suitable proprietary name of the 
new animal drug (if one is used) and the name and address of the 
distributor as used on the label and labeling. The name of the 
distributor shall be accompanied by an appropriate qualifying phrase 
such as ``manufactured for'' or ``distributed by.''
    (iii) A distributor's statement is furnished to the Food and Drug 
Administration identifying the category of his operations (for example, 
wholesaler, retailer) and stating: That he will distribute the new 
animal drug only under the labeling provided for in the new animal drug 
application; that any other labeling or advertising for the drug will 
prescribe, recommend, or suggest its use only under the conditions 
stated in the labeling provided for in the application; and, if the drug 
is a prescription article, that he is regularly and lawfully engaged in 
the distribution or dispensing of prescription drugs.
    (iv) Nine copies of the printed labels and other labeling to be used 
by the distributor are submitted, identified with the new animal drug 
application number.
    (b) When necessary for the safety or effectiveness of the drug, a 
supplemental new animal drug application shall specify a period of time 
within which the proposed change will be made.
    (c) If a material change is made in the components' composition, 
manufacturing methods, facilities, or controls, or in the labeling or 
advertising, from the representations in an approved application for a 
new animal drug (except changes conforming to the conditions set forth 
in paragraph (a)(5) and (6) and/or paragraphs (d), (e), (f), and (g) of 
this section), and the drug is marketed before a supplement is approved 
for such change, approval of the application may be suspended or 
withdrawn as provided in section 512(e) of the act.
    (d) Changes of the following kinds proposed in supplemental new 
animal drug applications should be placed into effect at the earliest 
possible time:
    (1) The addition to package labeling, promotional labeling, and 
prescription drug advertising of additional warning, contraindication, 
side effect, and precaution information.
    (2) The deletion from package labeling, promotional labeling, and 
drug advertising of false, misleading, or unsupported indications for 
use or claims for effectiveness.
    (3) Changes in the methods, facilities, or controls used for the 
manufacture, processing, packing, or holding of the new animal drug 
(other than utilization of establishments 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.
    (e) The Food and Drug Administration will take no action against a 
new animal drug or applicant solely because changes of the kinds 
described in paragraph (d) of this section are placed into effect by the 
applicant prior to his receipt of a written notice of approval of the 
supplemental new animal drug application if all the following conditions 
are met:
    (1) The supplemental new animal drug application providing a full 
explanation of the basis for the changes has been submitted, plainly 
marked on the mailing cover and on the supplement,

[[Page 70]]

``Special new animal drug application Supplement--changes being 
effected.''
    (2) The applicant specifically informs the Food and Drug 
Administration of the date on which such changes are being effected and 
submits to the Administration nine printed copies of any revised 
labeling to be placed in use, identified with the new animal drug 
application number.
    (3) All promotional labeling and all drug advertising are promptly 
revised consistent with the changes made in the labeling on or within 
the new animal drug package.
    (f) When a supplemental new animal drug application proposes changes 
only of the kinds described in paragraph (d) of this section, and the 
applicant informs the Food and Drug Administration that the changes are 
being put into effect, such notification will be regarded as an 
agreement by the applicant to an extension of the time for formal action 
on the application.
    (g) In addition to changes as permitted by paragraphs (d) and (e) of 
this section, an applicant may place into effect changes proposed in a 
supplement to a new animal drug application that became effective prior 
to October 10, 1962, upon written notification from the Food and Drug 
Administration that such action is permitted, without approval of the 
supplemental application, pending the completion of the review of the 
effectiveness of such drug by the National Academy of Sciences-National 
Research Council and a determination as to whether there are grounds for 
refusing approval under section 512(d) of the act or for invoking 
section 512(e) of the act. The Food and Drug Administration will take no 
action against a new animal drug or an applicant solely because changes 
that have been permitted in a written communication are placed into 
effect by the applicant prior to his receipt of a written notice of 
approval of the supplemental new animal drug application.
    (h) Except as provided in paragraphs (e) and (g) of this section, no 
provision of this section shall limit the authority of the Secretary or 
of the Commissioner to suspend or withdraw approval of a new animal drug 
application in accord with the provisions of section 512(e) of the act 
or to initiate any other regulatory proceedings with respect to a drug 
or applicant under provisions of the act.
    (i) Changes from the conditions of an approved new animal drug 
application in accord with the provisions of paragraphs (d), (e), and 
(g) of this section are permitted on the basis of a temporary deferral 
of final action on the supplemental application under the provisions of 
section 512 (c), (d), or (e) of the act.
    (j) When an applicant receives written notification from the Food 
and Drug Administration, under the provisions of paragraph (g) of this 
section, that he may place into effect changes proposed in a 
supplemental application without approval of the supplemental 
application, he may within 30 days submit a written request that the 
Food and Drug Administration process the supplemental application. In 
such case, the change shall not be put into effect until approved. 
Within 180 days of the receipt of such written request, the Food and 
Drug Administration will approve the supplemental application or furnish 
notice of an opportunity for a hearing under the provisions of section 
512 (d) or (e), or both, of the act on a proposal to refuse approval of 
the supplemental application or to withdraw approval of the application 
and supplements thereto.
    (k) A supplement to an application that became effective prior to 
October 10, 1962, may include a written statement to the effect that a 
temporary deferral of final action under the provisions of paragraph 
(d), (e), or (g) of this section is unacceptable to the applicant and 
that the applicant requests action as provided in section 512(c) of the 
act. Final action on such supplemental applications will be expedited in 
accord with applicable provisions of section 512 of the act and 
regulations in this subchapter E. In such cases, if the applicant places 
into effect any of the proposed changes prior to his receipt of a 
written notice of approval of the supplemental new animal drug 
application, such action may be regarded by the Food and Drug 
Administration as a basis for invoking the provisions of section 
512(e)(1)(D) of the act; that

[[Page 71]]

is, the applicant may be furnished notice of an opportunity for a 
hearing on a proposal to withdraw approval of the application on the 
ground that the application contains an untrue statement of a material 
fact related to the changes from the conditions approved in the 
application.
    (l) A supplemental application that contains nonclinical laboratory 
studies 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.

[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]

    Effective Date Note: At 68 FR 15365, Mar. 31, 2003, Sec.  514.8 was 
amended in paragraph (a)(1) by removing ``Sec.  510.300(a) of this 
chapter'' and by adding in its place ``Sec.  514.80''; in paragraph 
(a)(5) by removing ``Sec.  510.300(b)(4) of this chapter'' and by adding 
in its place ``Sec.  514.80(b)(4)''; in paragraph (a)(5)(ix) by removing 
``Sec.  510.300(b)(1) of this chapter'' and by adding in its place 
``Sec.  514.80 (b)(1)''; and by revising paragraph (a)(6), effective 
June 30, 2003. For the convenience of the user, the revised text is set 
forth as follows:

Sec.  514.8  Supplemental new animal drug applications.

    (a) * * *
    (6) Approval of a supplemental new animal drug application will not 
be required to provide for an additional distributor to distribute a 
drug which is the subject of an approved new animal drug application if 
the conditions described in Sec.  514.80(b)(5)(iii) are met before 
putting such a change into effect.

                                * * * * *



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.  510.300 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.
    (b) The existence of an NADA file will not be disclosed by the Food 
and Drug Administration before an approval has been published in the 
Federal Register, unless it has previously been publicly 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 an approval has been published in the Federal 
Register, no data or information contained in the file is available for 
public disclosure before such approval is published, 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, 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 an approval has been published in the Federal Register, 
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.

[[Page 72]]

    (b) Any inappropriate gratuitous comments unnecessary to an 
objective analysis of the data and information.
    (ii) For an NADA approved on or 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 approval is 
published in the Federal Register.
    (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.
    (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]

    Effective Date Note: At 68 FR 15365, Mar. 31, 2003, Sec.  514.11 was 
amended in paragraph (a) by removing ``510.300'' and adding in its place 
``514.80'', effective June 30, 2003.



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

[[Page 73]]

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.  510.300 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 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]

    Effective Date Note: At 68 FR 15365, Mar. 31, 2003, Sec.  514.15 was 
amended in paragraph (b) by removing ``Sec.  510.300'' and adding in its 
place ``Sec.  514.80'', effective June 30, 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.
------------------------------------------------------------------------

[[Page 74]]

 
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., forms to be submitted,
 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?
------------------------------------------------------------------------
                                          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?
------------------------------------------------------------------------

[[Page 75]]

 
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 forms do I need?                     514.80(d) Reporting forms.
What are Forms FDA 1932 and 2301?
How can I get them?
Can I use computer-generated
 equivalents?
------------------------------------------------------------------------
How long must I maintain Form FDA 1932    514.80(e) Records to be
 and records and reports of other          maintained.
 required information, i.e., how long do
 I need to maintain this information?
------------------------------------------------------------------------
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?
------------------------------------------------------------------------
How do I obtain Forms FDA 1932 and 2301?  514.80(g) Mailing addresses.
Where do I mail FDA's required forms,
 records, and reports?
------------------------------------------------------------------------
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 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)

[[Page 76]]

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.''
    (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 on Form FDA 1932, and its mailing cover must be plainly marked 
``15-Day NADA/ANADA Alert Report.''
    (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 on Form FDA 1932, 
and its mailing cover must be plainly marked ``15-Day NADA/ANADA Alert 
Report Followup.'' 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 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 
should submit the report on Form FDA 1932 within 15 working days of 
first receiving the information.
    (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 60 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. 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.
    (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

[[Page 77]]

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.
    (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 Sec.  
514.80(b)(1) and (b)(2) must be reported individually on Form FDA 1932.
    (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 separately from other 
experiences in the periodic drug experience report and clearly marked or 
highlighted.
    (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 previously submitted Form FDA 
1932, 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.
    (1) The distributor's labeling must be identical to that in the 
approved

[[Page 78]]

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) Reporting forms. Applicant must report adverse drug experiences 
and product/manufacturing defects on Form FDA 1932, ``Veterinary Adverse 
Drug Reaction, Lack of Effectiveness, Product Defect Report.'' Periodic 
drug experience reports and special drug experience reports must be 
accompanied by a completed Form FDA 2301 ``Transmittal of Periodic 
Reports and Promotional Material for New Animal Drugs,'' in accordance 
with directions provided on the forms. Computer-generated equivalents of 
Form FDA 1932 or Form FDA 2301, approved by FDA before use, may be used. 
Form FDA 1932 and Form FDA 2301 may be obtained on the Internet at 
http://www.fda.gov/cvm/forms/forms.html, by telephoning the 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. Completed 15-day alert reports, periodic drug 
experience reports, and special drug experience reports 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. Three-day alert reports must be submitted 
to the appropriate FDA district office or local FDA resident post. 
Addresses for district offices

[[Page 79]]

and resident posts may be obtained from the Internet at http://
www.fda.gov (click on ``Contact FDA,'' then ``FDA Field Offices'').
    (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]

    Effective Date Note: At 68 FR 15365, Mar. 31, 2003, Sec.  514.80 was 
added, effective June 30, 2003.



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:
    (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,

[[Page 80]]

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 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 drug not 
exempted by Sec.  514.8(a)(3)(i) and (a)(3)(ii).
    (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.

[[Page 81]]

    (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 listed in Sec.  
514.8(d).
    (xiv) Changes not requiring prior approval which are listed under 
Sec.  514.8(a)(5) when submitted as supplemental applications.
    (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]



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.
    (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

[[Page 82]]

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, l975, 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;
    (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

[[Page 83]]

    (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.
    (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]



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 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,

[[Page 84]]

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.
    (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.

[[Page 85]]



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 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

[[Page 86]]

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 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.

[[Page 87]]

    (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]



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  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 to refuse to approve an application or to 
withdraw the approval of an application will specify the grounds upon 
which he proposes to issue his order. On request of the applicant, the 
Commissioner will explain the reasons for his 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 he is required to file a written appearance electing 
whether:

[[Page 88]]

    (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, his 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, he is required to file a written appearance requesting the 
hearing within 30 days after the publication of the notice, giving the 
reason why the application should not be refused or should not be 
withdrawn, together with a well-organized and full-factual analysis of 
the clinical and other investigational data he 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 data in 
the application and from the reasons and a 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 withdrawal of 
approval of the application (for example, no adequate and well-
controlled clinical investigations to support the claims of 
effectiveness have been identified), the Commissioner will enter an 
order on this data, stating his 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 he 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 his appearance.

[40 FR 13825, Mar. 27, 1975, as amended at 43 FR 1941, Jan. 13, 1978]



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.

[[Page 89]]

              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 accordance with the 
applicable regulations published under section 512(i) 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 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 Sec. Sec.  207.20 and 207.21 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.



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.

[[Page 90]]

    (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 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) 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 preceed 
issuance of such notice of hearing.



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

[[Page 91]]

    (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 
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,

[[Page 92]]

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 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

[[Page 93]]

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 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS--Table of Contents




Sec.
520.23 Acepromazine maleate tablets.
520.44 Acetazolamide sodium soluble powder.
520.45 Albendazole oral dosage forms.
520.45a Albendazole suspension.
520.45b Albendazole paste.
520.48 Altrenogest solution.
520.62 Aminopentamide hydrogen sulphate tablets.
520.82 Aminopropazine fumarate oral dosage forms.
520.82a Aminopropazine fumarate tablets.
520.82b Aminopropazine fumarate, neomycin sulfate tablets.
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.
520.88f Amoxicillin trihydrate tablets.
520.88g Amoxicillin trihydrate and clavulanate potassium film-coated 
          tablets.
520.88h Amoxicillin trihydrate and clavulanate potassium for oral 
          suspension.
520.90 Ampicillin oral dosage forms.
520.90a Ampicillin capsules.
520.90b Ampicillin trihydrate tablets.
520.90c Ampicillin trihydrate capsules.
520.90d Ampicillin trihydrate for oral suspension.
520.90e Ampicillin trihydrate soluble powder.
520.90f Ampicillin trihydrate boluses.
520.100 Amprolium oral dosage forms.
520.100a Amprolium drinking water.
520.100b Amprolium drench.
520.100c Amprolium crumbles.
520.110 Apramycin sulfate soluble powder.
520.154 Bacitracin oral dosage forms.
520.154a Soluble bacitracin methylene disalicylate.
520.154b Soluble bacitracin methylene disalicylate and streptomycin 
          sulfate oral powder.
520.154c Bacitracin zinc soluble powder.
520.182 Bicyclohexylammonium fumagillin.
520.222 Bunamidine hydrochloride.
520.246 Butorphanol tartrate tablets.
520.260 n-Butyl chloride capsules.
520.300 Cambendazole oral dosage forms.
520.300a Cambendazole suspension.
520.300b Cambendazole pellets.
520.300c Cambendazole paste.
520.309 Carprofen.
520.310 Caramiphen ethanedisulfonate and ammonium chloride tablets.
520.312 Carnidazole tablets.
520.314 Cefadroxil tablets.
520.315 Cefadroxil powder for oral suspension.
520.390 Chloramphenicol oral dosage forms.
520.390a Chloramphenicol tablets.
520.390b Chloramphenicol capsules.
520.390c Chloramphenicol palmitate oral suspension.
520.420 Chlorothiazide tablets and boluses.
520.434 Chlorphenesin carbamate tablets.
520.445 Chlortetracycline oral dosage forms.
520.445a Chlortetracycline bisulfate/sulfamethazine bisulfate soluble 
          powder.
520.445b Chlortetracycline powder (chlortetracycline hydrochloride or 
          chlortetracycline bisulfate).
520.445c Chlortetracycline tablets and boluses.
520.446 Clindamycin capsules and tablets.
520.447 Clindamycin liquid.
520.452 Clenbuterol syrup.
520.455 Clomipramine hydrochloride tablets.
520.462 Clorsulon drench.
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.
520.550 Dextrose/glycine/electrolyte.
520.563 Diatrizoate meglumine and diatrizoate sodium oral solution.
520.580 Dichlorophene and toluene capsules.
520.581 Dichlorophene tablets.
520.600 Dichlorvos.
520.608 Dicloxacillin sodium monohydrate capsules.
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.
520.622d Diethylcarbamazine citrate capsules.
520.623 Diethylcarbamazine citrate, oxibendazole chewable tablets.
520.645 Difloxacin.
520.763 Dithiazanine iodide oral dosage forms.
520.763a Dithiazanine iodide tablets.

[[Page 94]]

520.763b Dithiazanine iodide powder.
520.763c Dithiazanine iodide and piperazine citrate suspension.
520.784 Doxylamine succinate tablets.
520.804 Enalapril tablets.
520.812 Enrofloxacin tablets.
520.813 Enrofloxacin oral solution.
520.816 Epsiprantel tablets.
520.823 Erythromycin phosphate.
520.863 Ethylisobutrazine hydrochloride tablets.
520.870 Etodolac.
520.903 Febantel oral dosage forms.
520.903a Febantel paste.
520.903b Febantel suspension.
520.903c [Reserved]
520.903d Febantel-praziquantel paste.
520.903e 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.
520.955 Florfenicol.
520.960 Flumethasone tablets.
520.970 Flunixin oral dosage forms.
520.970a Flunixin meglumine granules.
520.970b Flunixin meglumine paste.
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 soluble powder.
520.1100 Griseofulvin.
520.1120 Haloxon oral dosage forms.
520.1120a Haloxon drench.
520.1120b Haloxon boluses.
520.1130 Hetacillin oral dosage forms.
520.1130a Hetacillin potassium capsules.
520.1130b Hetacillin potassium oral suspension.
520.1130c Hetacillin potassium tablets.
520.1157 Iodinated casein tablets.
520.1158 Iodochlorhydroxyquin boluses.
520.1182 Iron dextran oral suspension.
520.1192 Ivermectin paste.
520.1193 Ivermectin tablets and chewables.
520.1195 Ivermectin liquid.
520.1196 Ivermectin and pyrantel pamoate chewable tablets.
520.1197 Ivermectin sustained-release bolus.
520.1204 Kanamycin sulfate, aminopentamide hydrogen sulfate, pectin, 
          bismuth subcarbonate, activated attapulgite suspension.
520.1205 Kanamycin sulfate, pectin, bismuth subcarbonate, activated 
          attapulgite tablets.
520.1242 Levamisole hydrochloride oral dosage forms.
520.1242a Levamisole hydrochloride drench and drinking water.
520.1242b Levamisole hydrochloride tablet or oblet (bolus).
520.1242c Levamisole hydrochloride and piperazine dihydrochloride.
520.1242d Levamisole resinate.
520.1242e Levamisole hydrochloride effervescent tablets.
520.1242f Levamisole hydrochloride gel.
520.1242g Levamisole resinate and famphur paste.
520.1263 Lincomycin hydrochloride monohydrate oral dosage forms.
520.1263a Lincomycin hydrochloride monohydrate tablets and sirup.
520.1263b Lincomycin hydrochloride monohydrate and spectinomycin sulfate 
          tetrahydrate soluble powder.
520.1263c Lincomycin hydrochloride soluble powder.
520.1284 Sodium liothyronine tablets.
520.1288 Lufenuron tablets.
520.1289 Lufenuron suspension.
520.1310 Marbofloxacin tablets.
520.1320 Mebendazole oral.
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 acetate tablets.
520.1380 Methocarbamol tablets.
520.1390 (S)-methoprene.
520.1408 Methylprednisolone tablets.
520.1409 Methylprednisolone, aspirin tablets.
520.1422 Metoserpate hydrochloride.
520.1430 Mibolerone.
520.1445 Milbemycin oxime tablets.
520.1446 Milbemcyin oxime/lufenuron tablets.
520.1448 Monensin oral dosage forms.
520.1448a Monensin blocks.
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.
520.1452 Moxidectin gel.
520.1468 Naproxen granules.
520.1484 Neomycin sulfate soluble powder.
520.1485 Neomycin sulfate oral solution.
520.1510 Nitenpyram.
520.1615 Omeprazole.
520.1616 Orbifloxacin tablets.
520.1628 Oxfendazole powder and pellets.
520.1629 Oxfendazole paste.
520.1630 Oxfendazole suspension.
520.1631 Oxfendazole and trichlorfon paste.
520.1638 Oxibendazole paste.
520.1640 Oxibendazole suspension.
520.1660 Oxytetracycline.
520.1660a Oxytetracycline and carbomycin in combination.

[[Page 95]]

520.1660b Oxytetracycline hydrochloride capsules.
520.1660c Oxytetracycline hydrochloride tablets/boluses.
520.1660d Oxytetracycline hydrochloride soluble powder.
520.1696 Penicillin oral dosage forms.
520.1696a Buffered penicillin powder, penicillin powder with buffered 
          aqueous diluent.
520.1696b Penicillin G potassium in drinking water.
520.1696c Penicillin V potassium for oral solution.
520.1696d Penicillin V potassium tablets.
520.1720 Phenylbutazone oral dosage forms.
520.1720a Phenylbutazone tablets and boluses.
520.1720b Phenylbutazone granules.
520.1720c Phenylbutazone paste.
520.1720d Phenylbutazone gel.
520.1802 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.
520.1804 Piperazine phosphate capsules.
520.1805 Piperazine phosphate with thenium closylate tablets.
520.1806 Piperazine monohydrochloride liquid.
520.1807 Piperazine.
520.1840 Poloxalene.
520.1846 Polyoxyethylene (23) lauryl ether blocks.
520.1855 Ponazuril.
520.1870 Praziquantel tablets.
520.1871 Praziquantel/pyrantel pamoate tablets.
520.1872 Praziquantel, pyrantel pamoate, and febantel tablets.
520.1880 Prednisolone tablets.
520.1900 Primidone tablets.
520.1920 Prochlorperazine, isopropamide sustained release capsules.
520.1921 Prochlorperazine, isopropamide, with neomycin sustained-release 
          capsules.
520.1962 Promazine hydrochloride.
520.2002 Propiopromazine hydrochloride.
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; pyrantel tartrate pellets.
520.2087 Roxarsone soluble powder.
520.2088 Roxarsone tablets.
520.2089 Roxarsone liquid.
520.2098 Selegiline hydrochloride tablets.
520.2100 Selenium, vitamin E capsules.
520.2122 Spectinomycin dihydrochloride oral solution.
520.2123 Spectinomycin dihydrochloride pentahydrate oral dosage forms.
520.2123a Spectinomycin dihydrochloride pentahydrate tablets.
520.2123b Spectinomycin dihydrochloride pentahydrate soluble powder.
520.2150 Stanozolol oral dosage forms.
520.2150a Stanozolol tablets.
520.2150b Stanozolol chewable tablets.
520.2158 Streptomycin/dihydrostreptomycin oral dosage forms.
520.2158a Streptomycin sulfate oral solution.
520.2158b Dihydrostreptomycin tablets.
520.2158c Dihydrostreptomycin oral suspension.
520.2160 Styrylpyridinium, diethylcarbamazine oral dosage forms.
520.2170 Sulfabromomethazine sodium boluses.
520.2184 Sodium sulfachloropyrazine monohydrate.
520.2200 Sulfachlorpyridazine oral dosage forms.
520.2200a Sulfachlorpyridazine bolus.
520.2200b Sulfachlorpyridazine medicated milk and drinking water.
520.2200c Sulfachlorpyridazine tablets.
520.2220 Sulfadimethoxine oral dosage forms.
520.2220a Sulfadimethoxine oral solution and soluble powder.
520.2220b Sulfadimethoxine tablets and boluses.
520.2220c Sulfadimethoxine oral suspension.
520.2220d Sulfadimethoxine-ormetoprim tablets.
520.2240 Sulfaethoxypyridazine.
520.2240a Sulfaethoxypyridazine drinking water.
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 sodium drinking water solution.
520.2261b Sulfamethazine sodium soluble powder.
520.2280 Sulfamethizole and methenamine mandelate tablets.
520.2320 Sulfanitran and aklomide in combination.
520.2325 Sulfaquinoxaline oral dosage forms.
520.2325a Sulfaquinoxaline drinking water.
520.2325b Sulfaquinoxaline drench.
520.2330 Sulfisoxazole tablets.
520.2345 Tetracycline oral dosage forms.
520.2345a Tetracycline hydrochloride capsules.
520.2345b Tetracycline tablets.
520.2345c Tetracycline boluses.

[[Page 96]]

520.2345d Tetracycline hydrochloride soluble powder.
520.2345e Tetracycline oral liquid.
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 tablets.
520.2380 Thiabendazole oral dosage forms.
520.2380a Thiabendazole top dressing and mineral protein feed block.
520.2380b Thiabendazole drench or oral paste.
520.2380c Thiabendazole bolus.
520.2380d Thiabendazole, piperazine citrate suspension.
520.2380e Thiabendazole with trichlorfon.
520.2380f Thiabendazole, piperazine phosphate powder.
520.2455 Tiamulin soluble powder.
520.2456 Tiamulin liquid concentrate.
520.2473 Tioxidazole oral dosage forms.
520.2473a Tioxidazole granules.
520.2473b Tioxidazole paste.
520.2481 Triamcinolone acetonide tablets.
520.2482 Triamcinolone acetonide oral powder.
520.2520 Trichlorfon oral dosage forms.
520.2520b Trichlorfon and atropine.
520.2520e Trichlorofon boluses.
520.2520f Trichlorofon granules.
520.2520g Trichlorfon, phenothiazine, and piperazine dihydrochloride 
          powder.
520.2582 Triflupromazine hydrochloride tablets.
520.2604 Trimeprazine tartrate and prednisolone tablets.
520.2605 Trimeprazine tartrate and prednisolone capsules.
520.2610 Trimethoprim and sulfadiazine tablets.
520.2611 Trimethoprim and sulfadiazine oral paste.
520.2612 Trimethoprim and sulfadiazine oral suspension.
520.2613 Trimethoprim and sulfadiazine powder.
520.2640 Tylosin.

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

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



Sec.  520.23  Acepromazine maleate tablets.

    (a) Sponsors. See drug labeler codes in Sec.  510.600(c) of this 
chapter for identification of sponsors as follows:
    (1) For No. 000856, use of 5-, 10-, or 25-milligram tablets as in 
paragraph (b) of this section.
    (2) For No. 000010, use of 10- or 25-milligram tablets as in 
paragraph (c) of this section.
    (b) Conditions of use. It is used in dogs and cats as follows:
    (1) Indications for use. It is used in dogs and cats as a 
tranquilizer.
    (2) Amount. Dogs: 0.25 to 1.0 milligram per pound of body weight; 
Cats: 0.5 to 1.0 milligram per pound of body weight.
    (3) Limitations. The drug is administered orally. Dosage may be 
repeated as required. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.
    (c) Conditions of use. It is used in dogs as follows:
    (1) Indications for use. It is used in dogs as an aid in 
tranquilization and as a preanesthetic agent.
    (2) Amount. Dogs: 0.25 to 1.0 milligram per pound of body weight.
    (3) Limitations. The drug is administered orally. Dosage may be 
repeated as required. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

[46 FR 44443, Sept. 4, 1981, as amended at 49 FR 49091, Dec. 18, 1984; 
52 FR 666, Jan. 8, 1987; 53 FR 40727, Oct. 18, 1988; 56 FR 37473, Aug. 
7, 1991; 62 FR 35075, June 30, 1997]



Sec.  520.44  Acetazolamide sodium soluble powder.

    (a) Specifications. The drug is in a powder form containing 
acetazolamide sodium, USP equivalent to 25 percent acetazolamide 
activity.
    (b) Sponsor. See No. 053501 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use. (1) It is used in dogs as an aid in the 
treatment of mild congestive heart failure and for rapid reduction of 
intraocular pressure.\1\
---------------------------------------------------------------------------

    \1\ These conditions are NAS/NRC reviewed and deemed effective. 
Applications for these uses need not include effectiveness data as 
specified by Sec.  514.111 of this chapter, but may require 
bioequivalency and safety information.
---------------------------------------------------------------------------

    (2) It is administered orally at a dosage level of 5 to 15 
milligrams per pound of body weight daily.\1\
    (3) For use only by or on the order of a licensed veterinarian.\1\

[40 FR 13838, Mar. 27, 1975, as amended at 67 FR 78355, Dec. 24, 2002]

[[Page 97]]



Sec.  520.45  Albendazole oral dosage forms.



Sec.  520.45a  Albendazole suspension.

    (a)(1) Specifications. The product contains 11.36 percent 
albendazole.
    (2) Sponsor. See No. 000069 in Sec.  510.600 of this chapter.
    (3) Related tolerances. See Sec.  556.34 of this chapter.
    (4) Conditions of use in cattle--(i) Amount. 4.54 milligrams per 
pound of body weight (10 milligrams per kilogram).
    (ii) 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 stage 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 phlebotomum), bankrupt worm 
(Trichostrongylus colubriformis), nodular worm (Oesophagostomum 
radiatum)); adult and 4th stage larvae of lungworms (Dictyocaulus 
viviparus).
    (iii) Limitations. Administer as a single oral dose using dosing gun 
or dosing syringe. 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.
    (b)(1) Specifications. The product contains 4.55 or 11.36 percent 
albendazole.
    (2) Sponsor. See No. 000069 in Sec.  510.600(c) of this chapter.
    (3) Related tolerances. See Sec.  556.34 of this chapter.
    (4) Conditions of use in sheep--(i) Amount. 7.5 milligrams per 
kilogram of body weight (3.4 milligrams per pound).
    (ii) Indications for use. For removal and control of the following 
internal parasites of sheep: Adult liver flukes (Fasciola hepatica, 
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. Administer as a single oral dose using dosing gun 
or dosing syringe. 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. Consult your veterinarian for assistance in the 
diagnosis, treatment, and control of parasitism.

[54 FR 25115, June 13, 1989, as amended at 56 FR 50653, Oct. 8, 1991; 59 
FR 65711, Dec. 21, 1994; 60 FR 55658, Nov. 2, 1995; 61 FR 4875, Feb. 9, 
1996; 64 FR 1504, Jan. 11, 1999]



Sec.  520.45b  Albendazole paste.

    (a) Specifications. The product contains 30 percent albendazole.
    (b) Sponsor. See No. 000069 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.

[[Page 98]]

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]



Sec.  520.48  Altrenogest solution.

    (a) Specifications. Each milliliter (mL) of solution contains 2.2 
milligrams (mg) altrenogest.
    (b) Sponsor. See No. 057926 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) Amount. 1.0 mL per 110 pounds body weight 
(0.044 mg per kilogram) daily for 15 consecutive days.
    (2) Indications for use. For suppression of estrus in mares.
    (3) Limitations. For oral use in horses only; avoid contact with the 
skin. Do not administer to horses intended for use as food.

[66 FR 47960, Sept. 17, 2001]



Sec.  520.62  Aminopentamide hydrogen sulphate tablets.

    (a) Chemical name. 4-(Dimethylamino)-2,2-diphenylvaleramide hydrogen 
sulfate.
    (b) Specifications. Each tablet contains 0.2 milligram of the drug.
    (c) Sponsor. See No. 000856 in Sec.  510.600(c) of this chapter.
    (d) Conditions of use. (1) It is intended for use in dogs and cats 
only for the treatment of vomiting and/or diarrhea, nausea, acute 
abdominal visceral spasm, pylorospasm, or hypertrophic gastritis.
    Note: Not for use in animals with glaucoma because of the occurrence 
of mydriasis.
    (2) Dosage is administered by oral tablet every 8 to 12 hours, as 
follows:

------------------------------------------------------------------------
                                                               Dosage in
                 Weight of animal in pounds                   milligrams
------------------------------------------------------------------------
Up to 10....................................................         0.1
11 to 20....................................................         0.2
21 to 50....................................................         0.3
51 to 100...................................................         0.4
Over 100....................................................         0.5
------------------------------------------------------------------------


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.
    (3) For use only by or on the order of a licensed veterinarian.

[40 FR 13838, Mar. 27, 1975, as amended at 53 FR 27851, July 25, 1988]



Sec.  520.82  Aminopropazine fumarate oral dosage forms.



Sec.  520.82a  Aminopropazine fumarate tablets.

    (a) Specifications. The drug is in tablet form. Each tablet contains 
aminopropazine fumarate equivalent to 25 milligrams of aminopropazine 
base.
    (b) Sponsor. See No. 000061 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use. (1) The drug is used in dogs and cats for 
reducing excessive smooth muscle contractions, such as occur in urethral 
spasms associated with urolithiasis.\1\
    (2) It is administered at a dosage level of 1 to 2 milligrams per 
pound of body weight. The dosage can be repeated every 12 hours, as 
indicated.\1\
    (3) Not for use in animals intended for food purposes.
    (4) For use only by or on the order of a licensed veterinarian.\1\

[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]



Sec.  520.82b  Aminopropazine fumarate, neomycin sulfate tablets.

    (a) Specifications. The drug is in tablet form. Each tablet contains 
both aminopropazine fumarate equivalent to 25 milligrams of 
aminopropazine base and neomycin sulfate equivalent to 50 milligrams of 
neomycin base.

[[Page 99]]

    (b) Sponsor. See No. 000061 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use. (1) The drug is used in dogs to control 
bacterial diarrhea caused by organisms susceptible to neomycin and to 
reduce smooth muscle contractions.\1\
---------------------------------------------------------------------------

    \1\ These conditions are NAS/NRC reviewed and deemed effective. 
Applications for these uses need not include effectiveness data as 
specified by Sec.  514.111 of this chapter, but may require 
bioequivalency and safety information.
---------------------------------------------------------------------------

    (2) It is administered at a dosage level of one to two tablets per 
10 pounds of body weight twice daily for 3 days.\1\
    (3) Federal law restricts this drug to use by or on the order of a 
licensed veterinarian.\1\

[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]



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 of amoxicillin.
    (b) Sponsor. See No. 000069 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use--(1) Dogs--(i) Amount. 5 milligrams per pound 
of body weight, twice a day.
    (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. Administer for 5 to 7 days or 48 hours after all 
symptoms have subsided. If no improvement is seen in 5 days, review 
diagnosis and change therapy. Federal law restricts this drug to use by 
or on the order of a licensed veterinarian.
    (2) Cats--(i) Amount. 50 milligrams (5 to 10 milligrams per pound of 
body weight) once a day.
    (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. Administer for 5 to 7 days or 48 hours after all 
symptoms have subsided. If no improvement is seen in 5 days, review 
diagnosis and change therapy. 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]



Sec.  520.88b  Amoxicillin trihydrate for oral suspension.

    (a) Specifications. When reconstituted, each milliliter contains 
amoxicillin trihydrate equivalent to 50 milligrams of amoxicillin.
    (b) Sponsor. See No. 000069 in Sec.  510.600(c) of this chapter.
    (1) Conditions of use--(i) Dogs--(A) Amount. 5 milligrams per pound 
of body weight twice daily.
    (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. Use for 5 to 7 days or 48 hours after all symptoms 
have subsided. Federal law restricts this drug to use by or on the order 
of a licensed veterinarian.
    (ii) Cats--(A) Amount. 50 milligrams (5 to 10 milligrams per pound) 
once daily.

[[Page 100]]

    (B) Indications for use. Treatment of infections caused by 
susceptible strains of organisms as follows: upper respiratory tract due 
to Staphylococcus spp., Streptococcus spp., Hemophilus 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. Use for 5 to 7 days or 48 hours after all symptoms 
have subsided. Federal law restricts this drug to use by or on the order 
of a licensed veterinarian.
    (2) [Reserved]
    (c) Sponsor. See Nos. 000093 and 000856 in Sec.  510.600(c) of this 
chapter.
    (1) Conditions of use. Dogs--(i) Amount. 5 milligrams per pound of 
body weight twice daily.
    (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. Use for 5 to 7 days. Continue for 48 hours after 
all symptoms have subsided. If no improvement is seen in 5 days, review 
diagnosis and change therapy. 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]



Sec.  520.88c  Amoxicillin trihydrate oral suspension.

    (a) Specifications. Each 0.8-milliliter dose contains amoxicillin 
trihydrate equivalent to 40 milligrams of amoxicillin.
    (b) Sponsor. See No. 000069 in Sec.  510.600(c) of this chapter.
    (c) Related tolerances. See Sec.  556.510 of this chapter.
    (d) Conditions of use. Swine--(1) Amount. 40 milligrams orally, 
twice a day using a dosing pump.
    (2) Indications for use. Treatment of baby pigs under 10 pounds for 
porcine colibacillosis caused by Escherichia coli susceptible to 
amoxicillin.
    (3) Limitations. Treat animals for 48 hours after all symptoms have 
subsided but not beyond 5 days. 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]



Sec.  520.88d  Amoxicillin trihydrate soluble powder.

    (a) Specifications. Each gram contains amoxicillin trihydrate 
equivalent to 115.4 milligrams of amoxicillin.
    (b) Sponsor. See No. 000069 in Sec.  510.600(c) of this chapter.
    (c) Related tolerances. See Sec.  556.38 of this chapter.
    (d) Conditions of use. Preruminating calves including veal calves--
(1) Amount. 400 milligrams per 100 pounds of body weight twice daily.
    (2) Indications for use. Treatment of bacterial enteritis when due 
to susceptible Escherichia coli in preruminating calves including veal 
calves.
    (3) Limitations. Administer by drench or by mixing in milk. 
Treatment should be continued for 48 hours after all symptoms have 
subsided but not to exceed 5 days. For use in preruminating calves 
including veal calves only, not for use in other animals which are 
raised for food production. 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]



Sec.  520.88e  Amoxicillin trihydrate boluses.

    (a) Specifications. Each bolus contains the equivalent of 400 
milligrams of amoxicillin.
    (b) Sponsor. See No. 000069 in Sec.  510.600(c) of this chapter.

[[Page 101]]

    (c) Related tolerances. See Sec.  556.38 of this chapter.
    (d) Conditions of use. Preruminating calves including veal calves--
(1) Amount. 400 milligrams per 100 pounds of body weight twice daily.
    (2) Indications for use. Treatment of bacterial enteritis when due 
to susceptible Escherichia coli in preruminating calves including veal 
calves.
    (3) Limitations. For oral use in preruminating calves including veal 
calves only, not for use in other animals which are raised for food 
production. Treatment should be continued for 48 hours after all 
symptoms have subsided but not to exceed 5 days. 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]



Sec.  520.88f  Amoxicillin trihydrate tablets.

    (a) Specifications. Each tablet contains amoxicillin trihydrate 
equivalent to 50, 100, 200, or 400 milligrams of amoxicillin.
    (b) Sponsor. See Nos. 000093 and 000856 in Sec.  510.600(c) of this 
chapter.
    (c) Conditions of use--(1) Dogs--(i) Amount. 5 milligrams per pound 
of body weight twice a day.
    (ii) Indications for use. 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, Streptococcus spp., E. coli, Proteus 
mirabilis, and Staphylococcus spp.
    (iii) Limitations. Use for 5 to 7 days or 48 hours after all 
symptoms have subsided. If no improvement is seen in 5 days, review 
diagnosis and change therapy. Federal law restricts this drug to use by 
or on the order of a licensed veterinarian.
    (2) [Reserved]

[57 FR 37320, Aug. 18, 1992, as amended at 62 FR 13302, Mar. 20, 1997; 
67 FR 67521, Nov. 6, 2002]



Sec.  520.88g  Amoxicillin trihydrate and clavulanate potassium film-coated tablets.

    (a) Specifications. Each tablet contains amoxicillin trihydrate and 
clavulanate potassium, equivalent to either 50 milligrams of amoxicillin 
and 12.5 milligrams clavulanic acid, or 100 milligrams of amoxicillin 
and 25 milligrams clavulanic acid, or 200 milligrams amoxicillin and 50 
milligrams clavulanic acid or 300 milligrams amoxicillin and 75 
milligrams clavulanic acid.
    (b) Sponsor. See No. 000069 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.
    (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, nonbeta-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. Wounds, abscesses, cellulitis, and superficial/
juvenile pyoderma: Treat for 5 to 7 days or for 48 hours after all signs 
have subsided. If no improvement is seen after 5 days of treatment, 
discontinue therapy and reevaluate diagnosis. Deep pyoderma may require 
treatment for 21 days; do not treat for more than 30 days. Not for use 
in dogs maintained for breeding. 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.
    (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, nonbeta-lactamase producing S. aureus, Staphylococcus spp., 
Streptococcus spp., E. coli, and Pasteurella spp.

[[Page 102]]

Also, treatment of urinary tract infections (cystitis) due to 
susceptible strains of E. coli.
    (iii) Limitations. Skin and soft tissue infections: abscesses, 
cellulitis/dermatitis should be treated for 5 to 7 days or for 48 hours 
after all signs have subsided. If no response is seen after 3 days of 
treatment, therapy should be discontinued and diagnosis reevaluated. 
Urinary tract infections may require treatment for 10 to 14 days or 
longer. The maximum duration of treatment should not exceed 30 days. 
Safety of use in pregnant or breeding animals has not been established. 
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]



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. 000069 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.
    (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. Administer for 5 to 7 days or 48 hours after all 
symptoms subsided. Deep pyoderma may require 21 days, not to exceed 30 
days. If no improvement is seen in 5 days, discontinue therapy and 
reevaluate the case. Not for use in dogs maintained for breeding. 
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 
of amoxicillin and 12.5 milligrams clavulanic acid) twice daily.
    (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. Administer 48 hours after all symptoms have 
subsided. If no improvement is seen after 3 days of treatment, 
discontinue therapy and reevaluate diagnosis. Maximum duration of 
treatment should not exceed 30 days. Not for use in cats maintained for 
breeding. 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]



Sec.  520.90  Ampicillin oral dosage forms.



Sec.  520.90a  Ampicillin capsules.

    (a) Specifications. Each capsule contains 125 milligrams or 250 
milligrams of ampicillin.
    (b) Sponsor. See No. 000008 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, e.g., one 125 mg capsule per 14 to 25 pounds, 
given 2 to 4 times daily; for animals weighing 6 to 14 pounds, one 
capsule twice daily.
    (ii) Indications for use. Treatment of urinary tract infections 
(cystitis) due to Proteus spp., hemolytic and nonhemolytic streptococci, 
beta hemolytic streptococci, and Escherichia coli. In upper respiratory 
tract infections tracheobronchitis (kennel cough), tonsillitis due to 
alpha and beta hemolytic streptococci, hemolytic positive staphylococci, 
E. coli, and Proteus spp. In infections associated with abscesses, 
lacerations, and wounds due to Staphylococcus spp. and Streptococcus 
spp.
    (iii) Limitations. Bacteriologic studies to determine the causative 
organisms

[[Page 103]]

and their susceptibility to ampicillin should be performed. Use of the 
drug is contraindicated in animals with a history of an allergic 
reaction to any of the penicillins. Ampicillin is contraindicated in 
infections caused by penicillinase-producing organisms. 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) Cats--(i) Amount. 125 milligrams twice daily; in more acute 
conditions three times daily.
    (ii) Indications for use. Treatment of respiratory tract infections 
(bacterial pneumonia) due to alpha and beta hemolytic streptococci, 
hemolytic positive staphylococci, E. coli, and Proteus spp. In 
infections associated with abscesses, lacerations, and wounds due to 
Staphylococcus spp. and Streptococcus spp.
    (iii) Limitations. Bacteriologic studies to determine the causative 
organisms and their susceptibility to ampicillin should be performed. 
Use of the drug is contraindicated in animals with a history of an 
allergic reaction to any of the penicillins. Ampicillin is 
contraindicated in infections caused by penicillinase-producing 
organisms. 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.

[57 FR 37321, Aug. 18, 1992]



Sec.  520.90b  Ampicillin trihydrate tablets.

    (a) Specifications. Each tablet contains ampicillin trihydrate 
equivalent to 50 or 100 milligrams of ampicillin.
    (b) Sponsor. See No. 000069 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use. 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. Not for use in animals which have shown 
hypersensitivity to penicillin or for infections caused by 
penicillinase-producing organisms. 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.

[57 FR 37321, Aug. 18, 1992, as amended at 60 FR 55659, Nov. 2, 1995]



Sec.  520.90c  Ampicillin trihydrate capsules.

    (a) Specifications. Each capsule contains ampicillin trihydrate 
equivalent to 125, 250, or 500 milligrams of ampicillin.
    (b) Sponsor. See No. 055529 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. The drug may be given as an emergency measure; 
however, in vitro sensitivity tests on samples collected prior to 
treatment should be made. Ampicillin is contraindicated for use in 
infections caused by penicillinase-producing organisms and for use in 
animals known to be allergic to any of the penicillins. 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.

[[Page 104]]

    (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. The drug may be given as an emergency measure; 
however, in vitro sensitivity tests on samples collected prior to 
treatment should be made. Ampicillin is contraindicated for use in 
infections caused by penicillinase-producing organisms and for use in 
animals known to be allergic to any of the penicillins. 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 37321, Aug. 18, 1992, as amended at 58 FR 61016, Nov. 19, 1993]



Sec.  520.90d  Ampicillin trihydrate for oral suspension.

    (a) Specifications. When reconstituted as directed, each milliliter 
contains ampicillin trihydrate equivalent to 25 milligrams of 
ampicillin.
    (b) Sponsor. See No. 055529 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 orally, 2 or 3 times daily, 1 to 2 hours prior to 
feeding. In severe or acute conditions, 10 milligrams per pound of body 
weight 3 times daily.
    (ii) Indications for use. Treatment of respiratory tract infections 
(tracheobronchitis and tonsillitis) due to Escherichia coli, Pseudomonas 
spp., Proteus spp., Staphylococcus spp., and Streptococcus spp., urinary 
tract infections (cystitis) due to E. coli, Staphylococcus spp., 
Streptococcus spp., and Proteus spp.; bacterial gastroenteritis due to 
E. coli; generalized infections (septicemia) associated with abscesses, 
lacerations, and wounds, due to Staphylococcus spp. and Streptococcus 
spp.; bacterial dermatitis due to Staphylococcus spp., Streptococcus 
spp., Proteus spp., and Pseudomonas spp.
    (iii) Limitations. Duration of treatment is usually 3 to 5 days. 
Continue treatment 48 hours after the animal's temperature has returned 
to normal and all other signs of infection have subsided. If no response 
is obtained within 3 to 5 days, reevaluate diagnosis and treatment. 
Appropriate laboratory tests should be conducted, including in vitro 
culturing and susceptibility tests on samples collected prior to 
treatment. 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 
orally, 2 or 3 times daily, 1 to 2 hours prior to feeding.
    (ii) Indications for use. Treatment of respiratory tract infections 
(bacterial pneumonia) due to Staphylococcus spp., Streptococcus spp., E. 
coli, and Proteus spp.; urinary tract infections (cystitis) due to E. 
coli, Staphylococcus spp., Streptococcus spp., Proteus spp., and 
Corynebacterium spp.; generalized infections (septicemia) associated 
with abscesses, lacerations, and wounds, due to Staphylococcus spp., 
Streptococcus spp., Bacillus spp., and Pasteurella spp.
    (iii) Limitations. Duration of treatment is usually 3 to 5 days. 
Continue treatment 48 hours after the animal's temperature has returned 
to normal and all other signs of infection have subsided. If no response 
is obtained within 3 to 5 days, reevaluate diagnosis and treatment. 
Appropriate laboratory tests should be conducted, including in vitro 
culturing and susceptibility tests on samples collected prior to 
treatment. 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]



Sec.  520.90e  Ampicillin trihydrate soluble powder.

    (a) Specifications. Each gram contains ampicillin trihydrate 
equivalent to 88.2 milligrams of ampicillin.
    (b) Sponsor. See No. 055529 in Sec.  510.600(c) of this chapter.
    (c) Related tolerances. See Sec.  556.40 of this chapter.
    (d) Conditions of use. Swine--(1) Amount. 5 milligrams of ampicillin 
per

[[Page 105]]

pound of body weight twice daily, orally by gavage or in drinking water 
for up to 5 days.
    (2) Indications for use. Oral treatment of porcine colibacillosis 
(Escherichia coli) and salmonellosis (Salmonella spp.) infections in 
swine up to 75 pounds of body weight, and bacterial pneumonia caused by 
Pasteurella multocida, Staphylococcus spp., Streptococcus spp., and 
Salmonella spp.
    (3) Limitations. For use in swine only. Not for use in other animals 
which are raised for food production. Treated swine must not be 
slaughtered for food during treatment and for 24 hours following 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]



Sec.  520.90f  Ampicillin trihydrate boluses.

    (a) Specifications. Each bolus contains ampicillin trihydrate 
equivalent to 400 milligrams of ampicillin.
    (b) Sponsor. See No. 055529 in Sec.  510.600(c) of this chapter for 
use as in paragraph (d)(1), 000069 for use as in paragraph (d)(2).
    (c) Related tolerances. See Sec.  556.40 of this chapter.
    (d) Conditions of use. Nonruminating calves--(1) Amount. 5 
milligrams per pound of body weight twice daily for up to 5 days.
    (i) Indications for use. Oral treatment of colibacillosis caused by 
Escherichia coli, bacterial enteritis caused by Salmonella spp., and 
bacterial pneumonia caused by Pasteurella spp.
    (ii) Limitations. Treated calves must not be slaughtered for food 
during treatment and for 15 days after the last treatment. Not for use 
in other animals raised for food production. Federal law restricts this 
drug to use by or on the order of a licensed veterinarian.
    (2) Amount. 5 milligrams per pound of body weight twice daily not to 
exceed 4 days.
    (i) Indications for use. Oral treatment of bacterial enteritis 
(colibacillosis) caused by E. coli.
    (ii) Limitations. Treated calves must not be slaughtered for food 
during treatment and for 7 days after the last treatment. Not for use in 
other animals raised for food production. 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]



Sec.  520.100  Amprolium oral dosage forms.



Sec.  520.100a  Amprolium drinking water.

    (a) Chemical name. 1-(4-Amino-2-n-propyl-5-pyrimidinylmethyl)-2-
picolinium chloride hydrochloride.
    (b) Sponsor. See No. 050604 in Sec.  510.600 (c) of this chapter.
    (c) Related tolerances. See Sec.  556.50 of this chapter.
    (d) Conditions of use. It is used in drinking water as follows:
    (1) Chickens and turkeys--(i) Amount. 20 percent soluble powder.
    (ii) Indications for use. Treatment of coccidiosis.
    (iii) Limitations. Administer at the 0.012 percent level in drinking 
water as soon as coccidiosis is diagnosed and continue for from 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; no other source of drinking water should be available to 
the birds during this time; as sole source of amprolium.
    (2) Calves--(i) Amount. 9.6 percent solution or 20 percent soluble 
powder.
    (a) Indications for use. As an aid in the treatment of coccidiosis 
caused by Eimeria bovis and E. zurnii.
    (b) Limitations. Add 16 fluid ounces of the 9.6 percent solution to 
each 100 gallons of drinking water; or 4 ounces of the soluble powder to 
each 50 gallons of drinking water; at the usual rate of water 
consumption, this will provide an intake of approximately 10 milligrams 
per kilogram (2.2 pounds) of body weight; offer this solution as the 
only source of water for 5 days; for a satisfactory diagnosis, a 
microscopic examination of the feces should be done by a veterinarian or 
diagnostic laboratory before treatment; when treating outbreaks, the 
drug should be administered promptly after diagnosis is determined; 
withdraw 24 hours before slaughter.
    (ii) Amount. 9.6 percent solution or 20 percent soluble powder.

[[Page 106]]

    (a) Indications for use. As an aid in the prevention of coccidiosis 
caused by Eimeria bovis and E. zurnii.
    (b) Limitations. Add 8 fluid ounces of the 9.6 percent solution or 4 
ounces of the 20 percent soluble powder to each 100 gallons of drinking 
water; at the usual rate of water consumption, this will provide an 
intake of approximately 5 milligrams per kilogram (2.2 pounds) of body 
weight; offer this solution as the only source of water for 21 days 
during periods of exposure or when experience indicates that coccidiosis 
is likely to be a hazard; withdraw 24 hours before slaughter.

[40 FR 13838, Mar. 27, 1975, as amended at 62 FR 63270, Nov. 28, 1997]



Sec.  520.100b  Amprolium drench.

    (a) Chemical name. 1-(4-Amino-2-n-propyl - 5 - pyrimidinylmethyl) - 
2 - picolinium chloride hydrochloride.
    (b) Sponsor. See No. 050604 in Sec.  510.600(c) of this chapter.
    (c) Related tolerances. See Sec.  556.50 of this chapter.
    (d) Conditions of use. It is used for calves as follows:
    (1) Amount. 9.6 percent solution or 20 percent soluble powder.
    (i) Indications for use. As an aid in the treatment of coccidiosis 
caused by Eimeria bovis and E. zurnii.
    (ii) Limitations. Add 3 fluid ounces of the 9.6 percent solution to 
1 pint of water or 3 ounces of the 20 percent soluble powder to each 
quart of water and with a dose syringe administer 1 fluid ounce of this 
solution for each 100 pounds of body weight; this will provide a dose of 
approximately 10 milligrams per kilogram (2.2 pounds) of body weight; 
administer daily for 5 days; for a satisfactory diagnosis, a microscopic 
examination of the feces should be done by a veterinarian or diagnostic 
laboratory before treatment; when treating outbreaks, the drug should be 
administered promptly after diagnosis is determined; withdraw 24 hours 
before slaughter.
    (2) Amount. 9.6 percent solution or 20 percent soluble powder.
    (i) Indications for use. As an aid in the prevention of coccidiosis 
caused by Eimeria bovis and E. zurnii.
    (ii) Limitations. Add 1\1/2\ fluid ounces of the 9.6 percent 
solution to 1 pint of water or 1\1/2\ ounces of the 20 percent soluble 
powder to each quart of water and with a dose syringe administer 1 fluid 
ounce of this solution for each 100 pounds of body weight; this will 
provide a dose of approximately 5 milligrams per kilogram (2.2 pounds) 
of body weight; administer daily for 21 days during periods of exposure 
or when experience indicates that coccidiosis is likely to be a hazard; 
withdraw 24 hours before slaughter.

[40 FR 13838, Mar. 27, 1975, as amended at 62 FR 63270, Nov. 28, 1997]



Sec.  520.100c  Amprolium crumbles.

    (a) Specifications. Amprolium crumbles contain 1.25 percent 
amprolium.
    (b) Sponsor. See No. 050604 in Sec.  510.600(c) of this chapter.
    (c) Related tolerances. See Sec.  556.50 of this chapter.
    (d) Conditions of use. It is top-dressed on or thoroughly mixed in 
the daily feed ration of calves as follows:
    (1) Amount. 1.6 ounces of crumbles per 250 pounds of body weight per 
day (5 milligrams per kilogram of body weight).
    (i) Indications for use. As an aid in the prevention of coccidiosis 
caused by Eimeria bovis and E. zurnii.
    (ii) Limitations. Administer for 21 consecutive days during periods 
of exposure or when experience indicates that coccidiosis is likely to 
be a hazard. Withdraw 24 hours before slaughter. Use as sole source of 
amprolium.
    (2) Amount. 3.2 ounces of crumbles per 250 pounds of body weight per 
day (10 milligrams per kilogram of body weight).
    (i) Indications for use. As an aid in the treatment of coccidiosis 
caused by Eimeria bovis and E. zurnii.
    (ii) Limitations. Administer for 5 consecutive days. For 
satisfactory diagnosis, a microscopic fecal examination should be done 
by a veterinarian or diagnostic laboratory before treatment. When 
treating outbreaks, the drug should be administered promptly after 
diagnosis is determined. Withdraw 24 hours before slaughter. Use as sole 
source of amprolium.

[42 FR 41855, Aug. 19, 1977, as amended at 62 FR 63270, Nov. 28, 1997]

[[Page 107]]



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. 000986 in Sec.  510.600(c) of this chapter.
    (c) Related tolerances. See Sec.  556.52 of this chapter.
    (d) Conditions of use. (1) In swine for control of porcine 
colibacillosis (weanling pig scours) caused by strains of E. coli 
sensitive to apramycin.
    (2) It is administered for 7 days in drinking water at the rate of 
12.5 milligrams of apramycin per kilogram (5.7 milligrams per pound) of 
body weight per day. Swine will normally consume 1 gallon per day of 
medicated water containing 375 milligrams of apramycin for each 66 
pounds of body weight. Water consumption should be monitored to 
determine that the required amount of apramycin is being consumed. The 
drug concentration should be adjusted according to water consumption 
which varies depending on ambient temperature, humidity, and other 
factors.
    (3) Prepare fresh medicated water daily.
    (4) Do not slaughter treated swine for 28 days following treatment

[47 FR 15771, Apr. 13, 1982, as amended at 49 FR 19642, May 9, 1984; 53 
FR 37753, Sept. 28, 1988]



Sec.  520.154  Bacitracin oral dosage forms.



Sec.  520.154a  Soluble bacitracin methylene disalicylate.

    (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. 046573 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 per gallon in drinking water.
    (ii) Indications for use. Aid in the control of transmissible 
enteritis complicated by organisms susceptible to bacitracin methylene 
disalicylate.
    (iii) Limitations. Prepare a fresh solution daily.
    (2) Broiler and replacement chickens--(i) Amount. 100 milligrams per 
gallon in drinking water.
    (A) Indications for use. Aid in the prevention of necrotic enteritis 
caused by Clostridium perfringens susceptible to bacitracin methylene 
disalicylate.
    (B) Limitations. Prepare a fresh solution daily.
    (ii) Amount. 200 to 400 milligrams per gallon in drinking water.
    (A) Indications for use. Aid in the control of necrotic enteritis 
caused by C. perfringens susceptible to bacitracin methylene 
disalicylate.
    (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 Treponema 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 milligrams per gallon in drinking 
water.
    (ii) Indications for use. For prevention of ulcerative enteritis due 
to Clostridium colinum susceptible to bacitracin methylene disalicylate.
    (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]



Sec.  520.154b  Soluble bacitracin methylene disalicylate and streptomycin sulfate oral powder.

    (a) Specifications. Each gram contains 200 units of soluble 
bacitracin methylene disalicylate, streptomycin sulfate equivalent to 20 
milligrams of streptomycin, and 850 milligrams of carob flour.

[[Page 108]]

    (b) Sponsor. See No. 062925 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use. Dogs--(1) Amount. 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. 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. If no improvement is noted in 2 to 3 days, 
diagnosis should be reevaluated. 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 61 FR 66581, Dec. 18, 1996]



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. 053501 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]



Sec.  520.182  Bicyclohexylammonium fumagillin.

    (a) Specifications. The drug is a sol- uble powder containing 
bicyclohexylammonium fumagillin and appropriate phosphate buffers.
    (b) Sponsor. See No. 059620 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use. (1) The drug is used for the prevention of 
nosema in honey bees.\1\
---------------------------------------------------------------------------

    \1\ These conditions are NAS/NRC reviewed and deemed effective. 
Applications for these uses need not include effectiveness data as 
specified by Sec.  514.111 of this chapter, but may require 
bioequivalency and safety information.
---------------------------------------------------------------------------

    (2) It is administered usually in a 2:1 sugar sirup containing a 
concentration of from 75 to 100 milligrams of fumagillin activity per 
gallon of sugar sirup.\1\
    (3) Colonies used for package production should be fed medicated 
sirup as a principal food supply for a month prior to stocking nuclei or 
shaking packages for market.\1\
    (4) The medicated sirup should not be fed immediately before or 
during the honey flow.

[40 FR 13838, Mar. 27, 1975, as amended at 42 FR 65151, Dec. 30, 1977; 
56 FR 43699, Sept. 4, 1991; 58 FR 5608, Jan. 22, 1993]



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

[[Page 109]]

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 tartrate tablets.

    (a) Specifications. Each tablet contains 1, 5, or 10 milligrams of 
butorphanol base activity as butorphanol tartrate.
    (b) Sponsor. See No. 000856 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use. The drug is used for the treatment of dogs as 
follows:
    (1) Amount. 0.25 milligram of butorphanol base activity per pound of 
body weight.
    (2) 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.
    (3) Limitations. For oral use in dogs only. Repeat at intervals of 6 
to 12 hours as required. If necessary, increase dose to a maximum of 0.5 
milligram per pound of body weight. Treatment should not normally be 
required for longer than 7 days. Federal law restricts this drug to use 
by or on the order of a licensed veterinarian.

[47 FR l4702, Apr. 6, 1982, as amended at 53 FR 27851, July 25, 1988]



Sec.  520.260  n-Butyl chloride capsules.

    (a)(1) Specifications. n-Butyl chloride capsules, veterinary contain 
272 milligrams or 816 milligrams of n-butyl chloride in each capsule.
    (2) Sponsor. See No. 021091 in Sec.  510.600(c) of this chapter.
    (3) Conditions of use. (i) It is used for the removal of ascarids 
(Toxocara canis and Toxascaris leonina) and hookworms (Ancylostoma 
caninum, Ancylostoma braziliense, and Uncinaria stenocephala) from dogs 
and of the ascarid (Toxocara cati) and hookworm (Ancylostoma tubaeforme) 
from cats.
    (ii)(a) Animals should not be fed for 18 to 24 hours before being 
given the drug. Puppies and kittens should be wormed at 6 weeks of age. 
However, if heavily infested, they may be wormed at 4 or 5 weeks of age. 
Administration of the drug should be followed in \1/2\ to 1 hour with a 
teaspoonful to a tablespoonful of milk of magnesia or 1 or 2 milk of 
magnesia tablets. Normal rations may be resumed 4 to 8 hours after 
treatment. Puppies and kittens should be given a repeat treatment in a 
week or 10 days. After that they should be treated every 2 months (or as 
symptoms reappear) until a year old. When the puppy or kitten is a year 
old, one treatment every 3 to 6 months is sufficient.
    (b) For dogs or cats that have been wormed regularly, treatment 
every 3 to 6 months will be sufficient. If a dog or cat has not been 
wormed previously and has the symptoms of large roundworms a dose should 
be given and repeated in 10 days. Removal of hookworms may require 3 or 
4 doses at 10-day intervals.
    (c) Puppies, dogs, cats, or kittens weighing 1 to 3 pounds should be 
given 2 capsules per dose which contain 272 milligrams of n-butyl 
chloride each. Such animals weighing 4 to 5 pounds should be given 3 
such capsules. Animals weighing 6 to 7 pounds should be given 4 such 
capsules and animals weighing 8 to 9 pounds should be given 5 such 
capsules. Animals weighing 10 to 20 pounds should be given 3 capsules 
which contain 816 milligrams of n-butyl chloride each, animals weighing 
20 to 40 pounds should be given 4 such capsules and animals weighing 
over 40 pounds should be given 5 such capsules with the maximum dosage 
being 5 capsules, each of which contains 816 milligrams of n-butyl 
chloride.
    (iii) A veterinarian should be consulted before using in severely 
debilitated dogs or cats and also prior to repeated use in cases which 
present signs of persistent parasitism.

[[Page 110]]

    (b)(1) Specifications. n-Butyl chloride capsules contain 221, 442, 
884, or 1,768 milligrams or 4.42 grams of n-butyl chloride in each 
capsule. \1\
---------------------------------------------------------------------------

    \1\ These conditions are NAS/NRC reviewed and deemed effective. 
Applications for these uses need not include effectiveness data as 
specified by Sec.  514.111 of this chapter.
---------------------------------------------------------------------------

    (2) Sponsors. See No. 023851 in Sec.  510.600(c) of this chapter for 
221, 442, 884, or 1,768 milligram or 4.42 gram capsules; No. 000115 or 
038782 for 884 or 1,768 milligram or 4.42 gram capsules; and No. 000069 
for 221 milligram capsules.
    (3) Conditions of use. (i) It is used for the removal of ascarids 
(Toxocara canis and Toxascaris leonina) and hookworms (Ancylostoma 
caninum, Ancylostoma braziliense, and Uncinaria stenocephala) from dogs. 
\1\
    (ii)(a) 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. \1\
    (b) The drug is administered orally to dogs. Capsules containing 221 
milligrams of n-butyl chloride are administered to dogs weighing under 5 
pounds at a dosage level of 1 capsule per 1\1/4\ pound of body weight. 
Capsules containing 442 milligrams of n-butyl chloride are administered 
to dogs weighing under 5 pounds at a dosage level of 1 capsule per 2\1/
2\ pounds body weight. Capsules containing 884 milligrams of n-butyl 
chloride are administered to dogs as follows: Weighing under 5 pounds, 1 
capsule; weighing 5 to 10 pounds, 2 capsules; weighing 10 to 20 pounds, 
3 capsules; weighing 20 to 40 pounds, 4 capsules; over 40 pounds, 5 
capsules. Capsules containing 1,768 milligrams of n-butyl chloride are 
administered at a dosage level of 1 capsule per dog weighing 5 to 10 
pounds. Capsules containing 4.42 grams of n-butyl chloride are 
administered at a dosage level of 1 capsule per dog weighing 40 pounds 
or over. \1\
    (iii) A veterinarian should be consulted before using in severely 
debilitated dogs. \1\
    (c)(1) Specifications. n-Butyl chloride capsules, veterinary contain 
884 or 1,768 milligrams or 4.42 grams of n-butyl chloride in each 
capsule.
    (2) Sponsor. See No. 000115 in Sec.  510.600(c) of this chapter.
    (3) Conditions of use. (i) It is used for the removal of ascarids 
(Toxocara canis and Toxascaris leonina) and hookworms (Ancyclostoma 
caninum, Ancyclostoma braziliense, and Uncinaria stenocephala) from 
dogs.
    (ii)(a) 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 rations may be resumed 4 to 8 hours 
after treatment.
    (b) The drug is administered orally to dogs. Capsules containing 884 
milligrams of n-butyl chloride are administered to dogs as follows: 
weighing under 5 pounds, 1 capsule; weighing 5-10 pounds, 2 capsules; 
weighing 10-20 pounds, 3 capsules; weighing 20-40 pounds, 4 capsules; 
over 40 pounds, 5 capsules. Capsules containing 1,768 milligrams of n-
butyl chloride are administered at a dosage level of 1 capsule per dogs 
to dogs weighing 5-10 pounds and 2 capsules per dog to dogs weighing 20-
40 pounds. Capsules containing 4.42 grams of n-butyl chloride are 
administered at dosage level of 1 capsule per dog to dogs weighing 40 
pounds or over.
    (iii) A veterinarian should be consulted before using in severely 
debilitated dogs.

[40 FR 13838, Mar. 27, 1975, as amended at 40 FR 39858, Aug. 29, 1975; 
44 FR 10059, Feb. 16, 1979; 54 FR 38515, Sept. 19, 1989; 55 FR 24556, 
June 18, 1990; 64 FR 15684, Apr. 1, 1999]



Sec.  520.300  Cambendazole oral dosage forms.



Sec.  520.300a  Cambendazole suspension.

    (a) Specifications. Each fluid ounce contains 0.9 gram of 
cambendazole.
    (b) Sponsor. No. 050604 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use. (1) It is used in horses 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).

[[Page 111]]

    (2) It is administered 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).
    (3) 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.
    (4) Not for use in horses intended for food.
    (5) Caution: Do not administer to pregnant mares during first 3 
months of pregnancy.
    (6) 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]



Sec.  520.300b  Cambendazole pellets.

    (a) Specifications. The drug is in feed pellets containing 5.3 
percent cambendazole.
    (b) Sponsor. No. 050604 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use. (1) It is used in horses 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).
    (2) 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.
    (3) 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.
    (4) Not for use in horses intended for food.
    (5) Caution: Do not administer to pregnant mares during first 3 
months of pregnancy.
    (6) 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]



Sec.  520.300c  Cambendazole paste.

    (a) Specifications. The drug is a paste containing 45 percent 
cambendazole.
    (b) Sponsor. No. 050604 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use. (1) It is used in horses 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).
    (2) 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.
    (3) 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.
    (4) Not for use in horses intended for food.
    (5) Caution: Do not administer to pregnant mares during first 3 
months of pregnancy.
    (6) 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]



Sec.  520.309  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.
    (b) Sponsor. See No. 000069 in Sec.  510.600(c) of this chapter.
    (c) [Reserved]
    (d) 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.

[[Page 112]]

    (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 surgery.
    (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]



Sec.  520.310  Caramiphen ethanedisulfonate and ammonium chloride tablets.

    (a) Specifications. Each tablet contains 10 milligrams of 
5stcaramiphen ethanedisulfonate and 80 milligrams of ammonium 
chloride.\1\
---------------------------------------------------------------------------

    \1\ These conditions are NAS/NRC reviewed and deemed effective. 
Applications for these uses need not include effectiveness data as 
specified by Sec.  514.111 of this chapter, but may require 
bioequivalency and safety information.
---------------------------------------------------------------------------

    (b) Sponsor. See No. 000856 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.\1\
    (2) Indications for use. For relief of cough.\1\

[43 FR 55385, Nov. 28, 1978]



Sec.  520.312  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]



Sec.  520.314  Cefadroxil tablets.

    (a) Specifications. 50-, 100-, and 200-milligram tablets for dogs 
and cats; 1 gram tablet for dogs.
    (b) Sponsor. See No. 000856 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use. (1) For use in dogs as follows:
    (i) Indications for use. 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 
Staphylococcus aureus.
    (ii) Amount. Ten milligrams per pound of body weight twice daily.
    (iii) Limitations. The drug is administered orally. For skin and 
soft tissue infections, treatment should be continued for a minimum of 3 
days. For genitourinary tract infections, treatment should be continued 
for a minimum of 7 days. Continue treatment at least 48 hours after the 
dog has become afebrile or asymptomatic. If no response is seen after 3 
days of treatment, therapy should be discontinued and the case 
reevaluated. Do not treat for more than 30 days. Safety for use in 
pregnant bitches and stud dogs has not been determined. Federal law 
restricts this drug to use by or on the order of a licensed 
veterinarian.
    (2) For use in cats as follows:
    (i) Indications for use. For the treatment of skin and soft tissue 
infections including abscesses, wound infections, cellulitis, and 
dermatitis caused by susceptible strains of Pasteurella multocida, 
Staphylococcus aureus, Staphylococcus epidermidis, and Streptococcus 
spp.
    (ii) Amount. Ten milligrams per pound of body weight once daily.
    (iii) Limitations. The drug is administered orally. Continue 
treatment at least 48 hours after the cat has become afebrile or 
asymptomatic. If no response is seen after 3 days of treatment, therapy 
should be discontinued and the case reevaluated. Do not treat for more 
than 21 days. Safety for use in pregnant cats and breeding male cats has 
not been determined. Federal law

[[Page 113]]

restricts this drug to use by or on the order of a licensed 
veterinarian.

[47 FR 41105, Sept. 17, 1982, as amended at 49 FR 43052, Oct. 26, 1984; 
51 FR 4165, Feb. 3, 1986; 52 FR 11989, Apr. 14, 1987; 53 FR 27851, July 
25, 1988]



Sec.  520.315  Cefadroxil powder for oral suspension.

    (a) Specifications. Cefadroxil powder is reconstituted to form a 50 
milligram-per-milliliter aqueous suspension.
    (b) Sponsor. See No. 000856 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use. (1) For use in dogs as follows:
    (i) Indications for use. For treating genitourinary tract infections 
(cystitis) caused by susceptible strains of Escherichia coli, Proteus 
mirabilis, and Staphylococcus aureus; and skin and soft tissue 
infections including cellulitis, pyoderma, dermatitis, wound infections, 
and abscesses caused by susceptible strains of Staphylococcus aureus.
    (ii) Amount. 10 milligrams per pound of body weight, twice daily.
    (2) For use in cats as follows:
    (i) Indications for use. For treating skin and soft tissue 
infections including abscesses, wound infections, cellulitis, and 
dermatitis caused by susceptible strains of Pasteurella multocida, 
Staphylococcus aureus, Staphylococcus epidermidis, and Streptococcus 
spp.
    (ii) Amount. 10 milligrams per pound of body weight, once daily.
    (3) Limitations. Discard unused portion of reconstituted product 
after 14 days. Treatment should continue for 48 hours after animal is 
afebrile or asymptomatic. If no response after 3 days, discontinue 
treatment and reevaluate therapy. Not for use in animals raised for food 
production. Safe use in pregnant or breeding animals has not been 
established. Federal law restricts this drug to use by or on the order 
of a licensed veterinarian.

[53 FR 27344, July 20, 1988]



Sec.  520.390  Chloramphenicol oral dosage forms.



Sec.  520.390a  Chloramphenicol tablets.

    (a)(1) Specifications. Each tablet contains 100, 250, or 500 
milligrams, 1 or 2.5 grams of chloramphenicol.
    (2) Sponsor. In Sec.  510.600(c) of this chapter: No. 000010 for 
100-, 250-, and 500-milligram and 1-gram tablets; No. 000856 for 100-, 
250-. and 500-milligram tablets; No. 017030 for 100-milligram tablets; 
No. 000010 for 100-, 250-, and 500-milligram and 1- and 2.5-gram 
tablets; No. 000069 for 250-milligram tablets.
    (3) Conditions of use. Dogs--(i) Amount. 25 milligrams per pound of 
body weight every 6 hours.
    (ii) Indications for use. Oral treatment of bacterial pulmonary 
infections, bacterial infections of the urinary tract, bacterial 
enteritis, and bacterial infections associated with canine distemper 
caused by susceptible organisms.
    (iii) Limitations. Laboratory tests should be conducted, including 
in vitro culturing and susceptibility tests on samples collected prior 
to treatment. If no response to chloramphenicol therapy is obtained in 3 
to 5 days, discontinue its use and review diagnosis. Not for animals 
which are raised for food production. Chloramphenicol products 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. 
Because of potential antagonism, chloramphenicol should not be 
administered simultaneously with penicillin or streptomycin. Federal law 
restricts this drug to use by or on the order of a licensed 
veterinarian.
    (b)(1) Specifications. Each tablet contains 50, 100, 250, or 500 
milligrams, or 1 gram of chloramphenicol.
    (2) Sponsor. See No. 061623 in Sec.  510.600(c) of this chapter.
    (3) Conditions of use. Dogs--(i) Amount. 25 milligrams per pound of 
body weight every 6 hours.
    (ii) Indications for use. Oral treatment of bacterial 
gastroenteritis associated

[[Page 114]]

with bacterial diarrhea, bacterial pulmonary infections, and bacterial 
infections of the urinary tract caused by susceptible organisms.
    (iii) Limitations. Laboratory tests should be conducted, including 
in vitro culturing and susceptibility tests on samples collected prior 
to treatment. If no response is obtained in 3 to 5 days, discontinue use 
and reevaluate diagnosis. Not for animals that are raised for food 
production. Chloramphenicol products should not be administered in 
conjunction with or 2 hours prior to the induction of general anesthesia 
with pentobarbital because of prolonged recovery. Chloramphenicol should 
not be administered to dogs maintained for breeding purposes. Because of 
potential antagonism, chloramphenicol should not be administered 
simultaneously with penicillin or streptomycin. Federal law restricts 
this drug to use by or on the order of a licensed veterinarian.

[57 FR 37323, Aug. 18, 1992, as amended at 62 FR 35076, June 30, 1997; 
66 FR 14073, Mar. 9, 2001; 68 FR 4914, Jan. 31, 2003]



Sec.  520.390b  Chloramphenicol capsules.

    (a) Specifications. Each capsule contains 50, 100, 250, or 500 
milligrams of chloramphenicol.
    (b) Sponsor. (1) For chloramphenicol capsules containing 50, 100, 
250, or 500 milligrams of chloramphenicol see Nos. 000069, 000185, and 
027454 in Sec.  510.600(c) of this chapter.
    (2) For chloramphenicol capsules containing 100 or 250 milligrams of 
chloramphenicol see No. 058034 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.
    (2) Indications for use. Oral 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. Laboratory tests should be conducted including in 
vitro culturing and susceptibility tests on samples collected prior to 
treatment. This product 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, as amended at 63 FR 5255, Feb. 2, 1998]



Sec.  520.390c  Chloramphenicol palmitate oral suspension.

    (a) Specifications. Each milliliter contains chloramphenicol 
palmitate equivalent to 30 milligrams of chloramphenicol.
    (b) Sponsor. See No. 000856 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]



Sec.  520.420  Chlorothiazide tablets and boluses.

    (a)(1) Specifications. Each tablet contains 0.25 gram of 
chlorothiazide.
    (2) Sponsor. See No. 050604 in Sec.  510.600(c) of this chapter.
    (3) Conditions of use--(i) Amount. Usual dosage is 5 to 10 
milligrams per pound of body weight two or three times daily. \1\
---------------------------------------------------------------------------

    \1\ These conditions are NAS/NRC reviewed and deemed effective. 
Applications for these uses need not include effectiveness data as 
specified by Sec.  514.111 of this chapter, but may require 
bioequivalency and safety information.
---------------------------------------------------------------------------

    (ii) Indications for use. For use in dogs for treatment of 
congestive heart failure and renal edema. \1\
    (iii) Limitations. (a) Dosage must be adjusted to meet the changing 
needs of

[[Page 115]]

the individual animal. In mild and responsive cases, it is suggested 
that a dose of 5 milligrams per pound of body weight be administered two 
or three times daily. In moderately edematous and moderately responsive 
animals, a dose of 7.5 to 10 milligrams per pound of body weight may be 
administered three times daily. Severe conditions may require higher 
doses. Certain animals may respond adequately to intermittent therapy; 
in these cases, the drug may be administered either every other day or 
for 3 to 5 days each week.
    (b) Animals should be regularly and carefully observed for early 
signs of fluid and electrolyte imbalance. Take appropriate 
countermeasures if this should occur. In some dogs, hypochloremic 
alkalosis may occur (that is, excretion of chloride in relation to 
sodium is excessive; the plasma bicarbonate level increases and 
alkalosis results). Federal law restricts this drug to use by or on the 
order of a licensed veterinarian. \1\
    (b)(1) Specifications. Each bolus contains 2 grams of 
chlorothiazide.
    (2) Sponsor. See No. 000006 in Sec.  510.600(c) of this chapter.
    (3) Conditions of use--(i) Amount. 2 grams once or twice daily for 3 
or 4 days. \1\
    (ii) Indications for use. For use in cattle as an aid in reduction 
of postparturient udder edema. \1\
    (iii) Limitations. Animals should be regularly and carefully 
observed for early signs of fluid and electrolyte imbalance. Take 
appropriate countermeasures if this should occur. 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. \1\

[43 FR 39085, Sept. 1, 1978, as amended at 62 FR 63270, Nov. 28, 1997]



Sec.  520.434  Chlorphenesin carbamate tablets.

    (a) Specifications. Each tablet contains 400 milligrams of 
chlorphenesin carbamate.
    (b) Sponsor. See No. 000009 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 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. Not recommended for pregnant animals or those with 
a known hepatic dysfunction. Periodic liver function studies are 
recommended for animals on prolonged treatment. If no response is 
evident within 5 days of the beginning of treatment, the diagnosis 
should be redetermined and appropriate therapy instituted. Not 
recommended for use with general anesthetics other than the 
barbiturates. Federal law restricts this drug to use by or on the order 
of a licensed veterinarian.

[44 FR 16009, Mar. 16, 1979]



Sec.  520.445  Chlortetracycline oral dosage forms.



Sec.  520.445a  Chlortetracycline bisulfate/sulfamethazine bisulfate soluble powder.

    (a) Specifications. Each pound contains chlortetracycline bisulfate 
equivalent to 102.4 grams of chlortetracycline hydrochloride with 
sulfamethazine bisulfate equivalent to 102.4 grams of sulfamethazine.
    (b) Sponsor. See No. 053501 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. Swine--Used in drinking water as follows:
    (1) Amount. 250 milligrams of chlortetracycline with 250 milligrams 
of sulfamethazine per gallon.
    (2) Indications for use. Prevention and treatment of bacterial 
enteritis; aid in the reduction of the incidence of cervical abscesses; 
aid in the maintenance of weight gains in the presence of bacterial 
enteritis and atrophic rhinitis.

[[Page 116]]

    (3) Limitations. Not to be used for more than 28 consecutive days; 
withdraw 15 days before slaughter; as sole source of chlortetracycline 
and sulfonamide.

[57 FR 37323, Aug. 18, 1992, as amended at 67 FR 78355, Dec. 24, 2002]



Sec.  520.445b  Chlortetracycline powder (chlortetracycline hydrochloride or chlortetracycline bisulfate).

    (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 No. 053389 in Sec.  510.600(c) of this chapter for 
conditions of use as in paragraph (d) of this section; No. 053501 for 
conditions of use as in paragraph (d)(4) of this section; No. 000010 for 
conditions of use as in paragraphs (d)(4)(i)(A) and (B) and (d)(4)(ii) 
through (iv) of this section; Nos. 017519 and 059130 for conditions of 
use as in paragraphs (d)(4)(i)(A) and (B) and (d)(4)(ii) and (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 
(Hemophilus spp.), and Klebsiella spp.
    (2) Limitations. Prepare a fresh solution twice daily; as sole 
source of chlortetracycline; administer for not more than 5 days.
    (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 (Hemophilus 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.
    (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.
    (B) Amount. 400 to 800 milligrams per gallon.
    (1) Indications for use. Control of chronic respiratory disease and 
air-sac 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.
    (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.

[[Page 117]]

    (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.
    (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.
    (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 (Hemophilus spp.), and Klebsiella spp.
    (C) Limitations. Prepare fresh solution daily; as sole source of 
chlortetracycline; do not use for more than 5 days; for 000010 and 
017519 do not slaughter animals for food within 5 days of treatment; for 
053501 do not slaughter animals for food within 24 hours of treatment.
    (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 (Hemophilus 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.

[57 FR 37324, Aug. 18, 1992; 57 FR 42623, Sept. 15, 1992; 58 FR 61015, 
Nov. 19, 1993; 59 FR 39439, Aug. 3, 1994; 60 FR 26827, May 19, 1995; 60 
FR 47052, Sept. 11, 1995; 62 FR 27691, May 21, 1997; 62 FR 35076, June 
30, 1997; 62 FR 60656, Nov. 12, 1997; 64 FR 37673, July 13, 1999; 65 FR 
10706, Feb. 29, 2000; 66 FR 35898, July 10, 2001; 67 FR 78355, Dec. 24, 
2002]



Sec.  520.445c  Chlortetracycline tablets and boluses.

    (a) Specifications. Each tablet/bolus contains 25, 250, or 500 
milligrams of chlortetracycline hydrochloride.
    (b) Sponsors. See No. 000010 in Sec.  510.600(c) of this chapter for 
the 250-milligram chlortetracycline hydrochloride bolus; see No. 053501 
for the 25-milligram tablet and the 500 milligram bolus.
    (c) Related tolerances. See Sec.  556.150 of this chapter.
    (d) National Academy of Sciences/National Research Council NAS/NRC) 
status. The conditions of use specified in this section were NAS/NRC 
reviewed and found effective. Applications for these uses need not 
include effectiveness data as specified in Sec.  514.111 of this chapter 
but may require bioequivalency and safety information.
    (e) Conditions of use. 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 Hemophilus 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., Hemophilus spp., and 
Klebsiella spp., susceptible to chlortetracycline.

[[Page 118]]

    (ii) Limitations. Administer tablet 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; 
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., Hemophilus 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]



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 capsule contains the equivalent of 25, 75, or 150 mg 
clindamycin as the hydrochloride salt.
    (3) Each tablet 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) No. 000009 for use of capsules described in paragraph (a)(1) of 
this section as in paragraphs (d)(1)(i) and (d)(2)(i) of this section.
    (2) No. 059130 for use of capsules described in paragraph (a)(2) of 
this section as in paragraphs (d)(1)(ii) and (d)(2)(ii) of this section.
    (3) No. 059079 for use of tablets described in paragraph (a)(3) of 
this section as in paragraphs (d)(1)(ii) and (d)(2)(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 in dogs--(1) Amount--(i) Wounds, abscesses, 
and dental infections: 2.5 to 15 mg per pound (/lb) of body weight every 
12 hours for a maximum of 28 days. Osteomyelitis: 5.0 to 15 mg/lb of 
body weight every 12 hours for a minimum of 28 days.
    (ii) Wounds, abscesses, and dental infections: 2.5 mg/lb of body 
weight every 12 hours for a maximum of 28 days. Osteomyelitis: 5.0 mg/lb 
of body weight every 12 hours for a minimum of 28 days.
    (2) Indications for use--(i) 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.
    (ii) For the treatment of soft tissue infections (wounds and 
abscesses), dental infections, and osteomyelitis caused by susceptible 
strains of S. aureus, soft tissue infections (deep wounds and 
abscesses), dental infections, and osteomyelitis caused by or associated 
with susceptible strains of B. fragilis, P. melaninogenicus, F. 
necrophorum, and C. perfringens.

[67 FR 54954, Aug. 27, 2002]



Sec.  520.447  Clindamycin liquid.

    (a) Specifications. Each milliliter of solution contains the 
equivalent of 25 milligrams (mg) clindamycin as the hydrochloride salt.
    (b) Sponsors. See sponsors in Sec.  510.600(c) of this chapter as 
follows:
    (1) No. 000009 for use as in paragraphs (d)(1)(i)(A), (d)(1)(ii)(A), 
(d)(2)(i)(A), and (d)(2)(ii)(A) of this section.
    (2) Nos. 059079 and 059130 for use as in paragraphs (d)(1)(i)(B), 
(d)(1)(ii)(B), (d)(2)(i)(B), and (d)(2)(ii)(B) of this section.

[[Page 119]]

    (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--(A) Wounds, abscesses, 
and dental infections: 2.5 to 15 mg per pound (/lb) of body weight every 
12 hours for a maximum of 28 days. Osteomyelitis: 5.0 to 15 mg/lb of 
body weight every 12 hours for a minimum of 28 days.
    (B) Wounds, abscesses, and dental infections: 2.5 mg per pound (/lb) 
of body weight every 12 hours for a maximum of 28 days. Osteomyelitis: 
5.0 mg/lb of body weight every 12 hours for a minimum of 28 days.
    (ii) Indications for use--(A) 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.
    (B) For the treatment of soft tissue infections (wounds and 
abscesses), dental infections, and osteomyelitis caused by susceptible 
strains of S. aureus and for soft tissue infections (deep wounds and 
abscesses), dental infections, and osteomyelitis caused by or associated 
with susceptible strains of B. fragilis, P. melaninogenicus, F. 
necrophorum, and C. perfringens.
    (2) Cats--(i) Amount--(A) 5.0 to 15.0 mg/lb of body weight every 24 
hours for a maximum of 14 days.
    (B) 5.0 to 10.0 mg/lb of body weight every 24 hours for a maximum of 
14 days.
    (ii) Indications for use--(A) For the treatment of skin infections 
(wounds and abscesses) due to susceptible strains of S. 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.
    (B) Aerobic bacteria: Treatment of soft tissue infections (wounds 
and abscesses) and dental infections caused by or associated with 
susceptible strains of S. aureus, S. intermedius, and Streptococcus spp. 
Anaerobic bacteria: Treatment of soft tissue infections (deep wounds and 
abscesses) and dental infections caused by or associated with 
susceptible strains of C. perfringens and B. fragilis.

[67 FR 54954, Aug. 27, 2002, as amended at 67 FR 78684, Dec. 26, 2002]



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

[[Page 120]]

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]



Sec.  520.455   Clomipramine hydrochloride tablets.

    (a) Specifications. Each tablet contains 20, 40, or 80 milligrams of 
clomipramine hydrochloride.
    (b) Sponsor. See No. 058198 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]



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. 050604 in Sec.  510.600(c) of this chapter.
    (c) 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]



Sec.  520.530  Cythioate oral liquid.

    (a) Specifications. Each milliliter contains 15 milligrams of 
cythioate.
    (b) Sponsor. See Nos. 000859 and 053501 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. For oral use in dogs only. Do not use in greyhounds 
or in animals that are pregnant, sick, under stress, or recovering from 
surgery. 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]



Sec.  520.531  Cythioate tablets.

    (a) [Reserved]
    (b) Sponsors. See No. 000859 in Sec.  510.600(c) of this chapter for 
use of 30- and 90-milligram (mg) tablets and see No. 053501 in Sec.  
510.600(c) of this chapter for use of 30-mg tablet.
    (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. 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. For oral use in dogs only. Do not use in greyhounds 
or in animals that are pregnant, sick, under stress, or recovering from 
surgery. 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]

[[Page 121]]



Sec.  520.534  Decoquinate.

    (a) Specifications. The drug is a powder containing 0.8 percent 
decoquinate.
    (b) Sponsor. See No. 046573 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]



Sec.  520.538  Deracoxib.

    (a) Specifications. Each chewable tablet contains 25 or 100 
milligrams (mg) deracoxib.
    (b) Sponsor. See No. 058198 in Sec.  510.600(c) of this chapter.
    (c) [Reserved]
    (d) Conditions of use in dogs--(1) Amount. 3 to 4 mg per kilogram 
(kg) (1.4 to 1.8 mg per pound) of body weight once daily for 7 days, 
given orally.
    (2) Indications for use. For the control of postoperative pain and 
inflammation associated with orthopedic surgery in dogs weighing 4 or 
more pounds (1.8 kg).
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[67 FR 68760, Nov. 13, 2002]



Sec.  520.540  Dexamethasone oral dosage forms.





Sec.  520.540a  Dexamethasone powder.

    (a) Specifications. Dexamethasone powder is packaged in packets 
containing 10 milligrams of dexamethasone.
    (b) Sponsor. See No. 000061 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use. (1) Dexamethasone powder is indicated in 
cases where cattle and horses require additional steroid therapy 
following its parenteral administration. The drug is used as supportive 
therapy 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.
    (2) The drug is administered at a dosage level of 5 to 10 milligrams 
per animal the first day then 5 milligrams per day as required by drench 
or by sprinkling on a small amount of feed.
    (3) Clinical and experimental data have 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) Federal law restricts this drug to use by or on the order of a 
licensed veterinarian.

[40 FR 13838, Mar. 27, 1975; 41 FR 9149, Mar. 3, 1976; 52 FR 7832, Mar. 
13, 1987]



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. (i) Dexamethasone bolus is indicated in cases 
where cattle and horses require additional steroid therapy following its 
parenteral administration. The drug may be used as supportive therapy 
for management of inflammatory conditions such as acute arthritic 
lamenesses, and for various stress conditions where corticosteroids are 
required while the animal is being treated for a specific condition.
    (ii) Administered orally, 5 to 10 milligrams for the first day, then 
5 milligrams per day as required.
    (iii) Do not use in viral infections during the viremic stage. With 
bacterial infections, appropriate antibacterial therapy should be used.
    (iv) Do not use in animals with chronic nephritis and 
hypercorticalism (cushingoid syndrome), except for emergency therapy.

[[Page 122]]

    (v) Clinical and experimental data have demonstrated that 
corticosteroids administered orally or by injection 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.
    (vi) Federal law restricts this drug to use by or on the order of a 
licensed veterinarian.
    (b)(1) Specifications. Each tablet contains 0.25 milligram of 
dexamethasone.\1\
    (2) Sponsors. See Nos. 000061 and 061623 in Sec.  510.600(c) of this 
chapter.
    (3) Conditions of use--(i) Amount. Dogs: Administer orally at 0.25 
to 1.25 milligrams per day for up to 7 days. Cats: 0.125 to 0.5 
milligram per day for up to 7 days.\1\
    (ii) Indications for use. In treatment of dogs and cats as an anti-
inflammatory agent.\1\
---------------------------------------------------------------------------

    \1\ These conditions are NAS/NRC reviewed and deemed effective. 
Applications for these uses need not include effectiveness data as 
specified by Sec.  514.111 of this chapter.
---------------------------------------------------------------------------

    (iii) Limitations. (a) Clinical and experimental data have 
demonstrated that corticosteriods administered orally or by injection to 
animals may induce the first stage of parturition when administered 
during the last trimester of pregnancy; and they may precipitate 
premature parturition followed by dystocia, fetal death, retained 
placenta, and metritis.
    (b) Do not use in viral infections. Anti-inflammatory action of 
corticosteroids may mask signs of infections. Do not use in animals with 
tuberculosis, chronic nephritis, cushingoid syndrome, or peptic ulcers, 
except for emergency therapy.\1\
    (c) Federal law restricts this drug to use by or on the order of a 
licensed veterinarian.\1\

[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]



Sec.  520.540c  Dexamethasone chewable tablets.

    (a) Specifications. Each half-scored tablet contains 0.25 milligram 
of dexamethasone.\1\
    (b) Sponsor. See No. 000069 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use--(1) Amount. 0.25 to 1.25 milligrams per 
day.\1\
    (2) Indications for use. Supportive therapy in nonspecific 
dermatosis and inflammatory conditions in dogs.\1\
    (3) Limitations. (i) Administer by free-choice feeding or crumble 
over food. Administer 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.
    (ii) Clinical and experimental data have demonstrated that 
corticosteriods administered orally or parenterally to animals may 
induce the first stage of parturition when administered during the last 
trimester of pregnancy; and they may precipitate premature parturition 
followed by dystocia, fetal death, retained placenta, and metritis.
    (iii) Do not use in viral infections. Anti-inflammatory action of 
corticosteriods may mask signs of infection. Do not use in animals with 
tuberculosis, chronic nephritis, cushingoid syndrome, or peptic ulcers, 
except for emergency therapy.\1\
    (iv) 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]



Sec.  520.550  Dextrose/glycine/electrolyte.

    (a) Specifications. The product is distributed in packets each of 
which contains the following ingredients: sodium chloride 8.82 grams, 
potassium phosphate 4.20 grams, citric acid anhydrous 0.5 gram, 
potassium citrate 0.12 gram, aminoacetic acid (glycine) 6.36 grams, and 
dextrose 44.0 grams.
    (b) Sponsor. See No. 000069 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use. (1) Dextrose/glycine/electrolyte is indicated 
for use in the control of dehydration associated with diarrhea (scours) 
in calves. It is used as an early treatment at the first

[[Page 123]]

signs of scouring. It may also be used as followup treatment following 
intravenous fluid therapy.
    (2) Dissolve each packet in two 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 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.
    (3) The product should not be used in animals with severe 
dehydration (down, comatose, or in a state of shock). Such animals need 
intravenous therapy. Oral therapy in these cases is too slow. Animals 
which cannot drink after initial intravenous therapy may need to be 
dosed with a stomach tube or esophageal tube. Adequate colostrum intake 
during the first 12 hours is essential for healthy, vigorous calves. 
Antibacterial therapy is often indicated in bacterial scours due to E. 
coli and/or Salmonella. The product does not contain antibacterial 
agents. A veterinarian should be consulted in severely scouring calves 
or cases requiring antibacterial therapy. 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.

[48 FR 38606, Aug. 25, 1983, as amended at 56 FR 50653, Oct. 8, 1991; 60 
FR 55659, Nov. 2, 1995]



Sec.  520.563  Diatrizoate meglumine and diatrizoate sodium oral solution.

    (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. 053501 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use. (1) It is indicated for radiography of the 
gastrointestinal tract in dogs and cats.
    (2) It is administered orally at a dosage level of 0.5 to 1.0 
milliliter per pound of body weight by gavage or stomach tube. It is 
administered rectally at a dosage level of 0.5 to 1.0 milliliter per 
pound of body weight diluted with 1 part of the drug to 5 parts of 
water.
    (3) 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]



Sec.  520.580  Dichlorophene and toluene capsules.

    (a) Specifications. Each soft gelatin capsule contains 50 milligrams 
of dichlorophene and 60 milligrams of toluene or multiples thereof.
    (b) Sponsor. (1) For single dose only, see 000010, 000061, 000115, 
000842, 010237, 017135, 023851, 049968, 050906, and 058670 in Sec.  
510.600(c) of this chapter.
    (2) For single and multiple dose, see 000010, 000061, and 038782 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--(1) Amount. (i) Single dose of 100 milligrams 
of dicholorophene and 120 milligrams of toluene per pound of body 
weight.
    (ii) Divided dose of 100 milligrams of dichlorophene and 120 
milligrams of toluene per 5 pounds of body weight (20 and 24 milligrams 
per pound) daily for 6 days.
    (2) Indications for use. It is used 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]

[[Page 124]]


    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 on GPO Access.



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.  520.600  Dichlorvos.

    (a) Chemical name. 2,2-Dichlorvinyl dimethyl phosphate.
    (b) [Reserved]
    (c) Sponsor. See No. 000010 in Sec.  510.600(c) of this chapter.
    (d) Related tolerances. See Sec.  556.180 of this chapter.
    (e) Conditions of use in swine. (1) It is recommended 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.
    (2) The preparation should be added to the indicated amount of feed 
as set forth in paragraph (e)(2) of this section and administered 
shortly after mixing, as follows:

------------------------------------------------------------------------
                                                  Pounds of
                                     Pounds of   mixed feed    Number of
                                    feed to be      to be     pigs to be
Weight of [chyph] animal [chyph]in  mixed with  administered    treated
              pounds                 each 0.08   to each pig   per 0.08
                                     ounce of    as a single   ounce of
                                    dichlorvos    treatment   dichlorvos
------------------------------------------------------------------------
20-30.............................           4         0.33           12
31-40.............................           5         0.56            9
41-60.............................           6         1.00            6
61-80.............................           5         1.00            5
81-100............................           4         1.00            4
Adult Gilts, Sows, and Boars......          16         4.00            4
------------------------------------------------------------------------

    (3) 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.
    (f) Conditions of use in dogs. (1) 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.
    (2) The drug is in capsule form for direct administration and in 
pellet form for administration in about one-third of the regular canned 
dog food ration or in ground meat. Dogs may be treated with any 
combination of capsules and/or pellets so that the animal receives a 
single dose equaling 12 to 15 milligrams of the active ingredient per 
pound of body weight. One-half of the single recommended dosage may be 
given, and the other half may be administered 8 to 24 hours later. This 
split dosage schedule should be used in animals which are very old, 
heavily parasitized, anemic, or otherwise debilitated. The drug should 
not be used in dogs weighing less than 2 pounds.

[[Page 125]]

    (3) In some dogs, efficacy against Trichurias vulpis (whipworm) may 
be erratic. Dogs that do not develop a negative stool for Trichuris 
vulpis ova 10 to 14 days following initial treatment should be re-
treated. If a negative stool is not obtained in 10 to 14 days following 
re-treatment, alternate means of therapy should be considered.
    (4) Do not use in dogs infected with Dirofilaria immitis.
    (5) Do not use with other anthelmintics, taeniacides, antifilarial 
agents, muscle relaxants, or tranquilizers.
    (6) The drug is a cholinesterase inhibitor. Not for use 
simultaneously or within a few days before or after treatment with or 
exposure to cholinesterase-inhibiting drugs, pesticides, or chemicals.
    (7) Federal law restricts this drug to use by or on the order of a 
licensed veterinarian.
    (g) Conditions of use in horses when administered in grain. (1) It 
is recommended 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).
    (2) For a satisfactory diagnosis, a microscopic fecal examination 
should be performed by a veterinarian or a diagnostic laboratory prior 
to worming.
    (3) It is administered in the grain portion of the ration at a 
dosage of 14.2 milligrams to 18.5 milligrams per pound of body weight as 
a single dose. It may be 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 utilized.
    (4) 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.
    (5) 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.
    (h) Conditions of use in horses when administered orally by syringe. 
(1) It is recommended 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.
    (2) The product is in the form of a gel which is administered 
directly from a syringe onto the horse's tongue. The product is 
administered at a dosage level of 20 milligrams of dichlorvos per 
kilogram of body weight for the removal of bots and ascarids. The same 
dosage level is repeated 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.
    (3) 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. Do not administer in 
conjunction with or within 1 week of administration of muscle-relaxant 
drugs, phenothiazine derived tranquilizers, or central nervous system 
depressants.

[[Page 126]]

    (4) Do not use in horses which are severly debilitated or suffering 
from diarrhea or severe constipation, infectious disease, toxemia, or 
colic. Do not administer to horses affected with chronic alveolar 
emphysema (heaves) or other respiratory conditions.
    (5) Do not use in horses intended for food purposes.
    (6) Federal law restricts this drug to use by or on the order of a 
licensed veterinarian.
    (i) Conditions of use in dogs, cats, puppies, and kittens. (1) Each 
tablet contains 2, 5, 10, or 20 milligrams of dichlorvos.
    (2) It is administered orally at 5 milligrams of dichlorvos per 
pound of body weight.
    (3) Dogs and puppies: Removal and control of intestinal roundworms 
(Toxocara canis and Toxascaris leonina) and hookworms (Ancylostoma 
caninum and Uncinaria stenocephala).
    (4) Cats and kittens: Removal and control of intestinal roundworms 
(Toxocara cati and Toxascaris leonina) and hookworms (Ancylostoma 
tubaeforme and Uncinaria stenocephala).
    (5) Dichlorvos is a cholinesterase inhibitor. Do not use 
simultaneously with or within a few days before or after treatment with 
or exposure to cholinesterase-inhibiting drugs, pesticides, or 
chemicals.
    (6) Do not use in animals under 10 days of age or 1 pound of body 
weight.
    (7) Do not administer to animals showing signs of constipation, 
mechanical blockage of the intestinal tract, impaired liver function, or 
recently exposed to or showing signs of infectious disease.
    (8) Do not use in dogs or puppies infected with Dirofilaria immitis.
    (9) 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 48 FR 40704, Sept. 9, 1983; 
51 FR 28546, Aug. 8, 1986; 62 FR 35076, June 30, 1997; 64 FR 18571, Apr. 
15, 1999]



Sec.  520.608  Dicloxacillin sodium monohydrate capsules.

    (a) Specifications. Each capsule contains dicloxacillin sodium 
monohydrate equivalent to 50, 100, 200, or 500 milligrams of 
dicloxacillin.
    (b) Sponsor. See No. 000856 in Sec.  510.600 (c) of this chapter.
    (c) Conditions of use. Dogs--(1) Amount. 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. Treatment of pyoderma (pyogenic dermatitis) 
due to penicillinase-producing staphylococci sensitive to the drug.
    (3) Limitations. For the treatment of dogs only. Continue treatment 
for 24 to 48 hours after the animal has become afebrile or asymptomatic, 
Administer 1 to 2 hours before feeding to ensure maximum absorption. 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.

[57 FR 37325, Aug. 18, 1992]



Sec.  520.620  Diethylcarbamazine oral dosage forms.



Sec.  520.622  Diethylcarbamazine citrate oral dosage forms.



Sec.  520.622a  Diethylcarbamazine citrate tablets.

    (a) Sponsors. (1) See 015579 in Sec.  510.600(c) of this chapter for 
use of 50, 200, and 400 milligram tablets for prevention of heartworm 
disease in dogs and as an aid in the treatment of ascarid infections in 
dogs and cats.
    (2) See 053501 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 061623 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) See 017030 in Sec.  510.600(c) of this chapter for use of 50, 
100, 200, 300, and 400 milligram tablets for prevention of heartworm 
disease in dogs and as an aid in the treatment of ascarid infections in 
dogs and cats.

[[Page 127]]

    (5) See 000081 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. 000010 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. Administer orally either pulverized and given in 
feed or water or directly by mouth. For the treatment of ascarid 
infections, repeat in 10 to 20 days to remove immature worms that may 
enter the intestine from the lungs after the first dose. Do not treat 
dogs with established heartworm infections until they have been 
converted to a negative status by the use of adulticidal and 
microfilaricidal drugs. Inadvertent administration to heartworm-infected 
dogs may cause adverse reactions because of pulmonary occlusion. 
Overdosage may cause emesis. For prevention of heartworm disease in 
heartworm-endemic areas, administration of the drug should start at the 
beginning of mosquito activity and be continued daily throughout the 
mosquito season and for approximately a month thereafter. 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]



Sec.  520.622b  Diethylcarbamazine citrate syrup.

    (a)(1) Specifications. Each milliliter of syrup contains 60 
milligrams of diethylcarbamazine citrate.
    (2) Sponsor. See No. 053501 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)(1) Specifications. Each milliliter of syrup contains 60 
milligrams of diethylcarbamazine citrate.
    (2) Sponsors. (i) See No. 017030 for use as in paragraphs 
(b)(3)(ii)(a) and (b)(3)(ii)(c) of this section.

[[Page 128]]

    (ii) See No. 017030 for use as in paragraphs (b)(3)(ii) (a) and (c) 
of this section.
    (3) Conditions of use--(i) Amount. 3 milligrams per pound of body 
weight per day for prevention of heartworm disease and as an aid in 
control of large roundworms; 25 to 50 milligrams per pound of body 
weight as an aid in treatment of ascarid infections.
    (ii) Indications for use. (a) For prevention of heartworm disease 
(Dirofilaria immitis) in dogs.
    (b) As an aid in control of large roundworms (T. canis) in dogs.
    (c) As an aid in treatment of ascarid infections in dogs (T. canis) 
and cats (T. canis and T. leonina).
    (iii) Limitations. The drug may be placed on the daily ration or 
given directly by mouth. For treatment of ascarid infections, a repeat 
dose should be given in 10 to 20 days to remove immature worms which may 
enter the intestine from the lungs after the first dose. Older dogs 
should be proven negative for presence of Dirofilaria immitis infections 
before administering the drug. Dogs with established heartworm 
infections should not receive the drug until they have been converted to 
a negative status by the use of adulticidal and microfilaricidal drugs. 
Inadvertent administration to heartworm-infected dogs may cause adverse 
reactions due to pulmonary occlusion. Overdosage may cause emesis. For 
prevention of heartworm disease in heartworm-endemic areas, 
administration of the drug should start 1 month before the mosquito 
season and be continued daily throughout the mosquito season and for 2 
months thereafter. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.
    (c)(1) Specifications. Each milliliter of syrup contains 60 
milligrams of diethylcarbamazine citrate.
    (2) Sponsor. See No. 000010 in Sec.  510.600(c) of this chapter.
    (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]



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) For 015579, use of 30 or 120 milligram tablets as in paragraph 
(c)(2)(i) of this section.
    (2) For 000069, 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 000010, use of 30, 60, 120, or 180 milligram tablets as in 
paragraph (c)(2)(i) of this section.
    (7) [Reserved]
    (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

[[Page 129]]

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. Tablets are administered orally or pulverized and 
given in the feed. For treatment of ascarid infections, a repeat dose 
should be given in 10 to 20 days to remove immature worms which may 
enter the intestine from the lungs after the first dose. Dogs with 
established heartworm infections should not receive the drug until they 
have been converted to a negative status by the use of adulticidal and 
microfilaricidal drugs. Inadvertent administration to heartworm-infected 
dogs may cause adverse reactions due to pulmonary occlusion. Overdosage 
may cause emesis. For prevention of heartworm disease in heartworm-
endemic areas, administration of the drug should start at the beginning 
of mosquito activity and be continued daily throughout the mosquito 
season and for approximately a month thereafter. 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 on GPO Access.



Sec.  520.622d  Diethylcarbamazine citrate capsules.

    (a)(1) Specifications. Each capsule contains either 12.5, 50, 200, 
or 400 milligrams of diethylcarbamazine citrate.
    (2) Sponsor. See 011014 in Sec.  510.600(c) of this chapter.
    (3) Conditions of use--(i) Amount/indications for use. 3 milligrams 
per pound of body weight daily for prevention of heartworm disease 
(Dirofilaria immitis) in dogs; 25 to 50 milligrams per pound of body 
weight in a single dose as an aid in the treatment of ascarid infections 
in dogs (Toxocara canis and Toxascaris leonina).
    (ii) Limitations. Administer orally directly or added to the daily 
ration. For ascarid infections, repeat treatment in 10 to 20 days to 
remove immature worms that may enter the intestine from the lungs after 
the first dose. Do not treat dogs with established heartworm infections 
until they have been converted to a negative status by the use of 
adulticidal and microfilaricidal drugs. Inadvertent administration to 
heartworm-infected dogs may cause adverse reactions due to pulmonary 
occlusion or shock. Overdosage may cause emesis. For prevention of 
heartworm disease in heartworm-endemic areas, administration of the drug 
should begin 1 month before and continue 2 months after the mosquito 
season. Dogs receiving prophylactic therapy should be examined every 6 
months for the presence of microfilariae. Federal law restricts this 
drug to use by or on the order of a licensed veterinarian.
    (b)(1) Specifications. Each capsule contains either 12.5, 50, 200, 
or 400 milligrams of diethylcarbamazine citrate.
    (2) Sponsor. See 023851 in Sec.  510.600(c) of this chapter.
    (3) Conditions of use--(i) Amount/indications for use. 3 milligrams 
per pound of body weight daily for prevention of heartworm disease 
(Dirofilaria immitis) in dogs.
    (ii) Limitations. Capsules may be administered to the dog directly 
or added to the daily ration. For oral administration only. Do not treat 
dogs with established heartworm infections until they have been 
converted to a negative status by the use of adulticidal and 
microfilaricidal drugs. Inadvertent administration to heartworm infected 
dogs may cause adverse reactions due to pulmonary occlusion or shock. 
For prevention of heartworm disease in heartworm-endemic areas, 
administration of the drug should begin 1 month before and continue 2 
months after the mosquito season. Dogs receiving prophylactic therapy 
should be examined every 6 months for the presence of microfilariae. 
Federal law restricts

[[Page 130]]

this drug to use by or on the order of a licensed veterinarian.

[47 FR 26377, June 18, 1982, as amended at 48 FR 46979, Oct. 17, 1983; 
49 FR 5099, Feb. 10, 1984]



Sec.  520.623  Diethylcarbamazine citrate, 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 000069 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 immature stages of intestinal 
Toxocara canis (ascarid infection).
    (3) Limitations. Orally administer daily during heartworm season. 
For free-choice feeding or broken and placed on or mixed with feed. Do 
not use in dogs that may harbor adult heartworms. 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]



Sec.  520.645  Difloxacin.

    (a) Specifications. Each tablet contains 11.4, 45.4, or 136 
milligrams (mg) of difloxacin hydrochloride.
    (b) Sponsor. See No. 000856 in Sec.  510.600(c) of this chapter.
    (c) [Reserved]
    (d) Conditions of use--(1) Dogs--(i) Amount. 5 to 10 mg per kilogram 
(2.3 to 4.6 mg/pound) of body weight.
    (ii) Indications for use. For management of diseases in dogs 
associated with bacteria susceptible to difloxacin.
    (iii) Limitations. Use once a day for 2 to 3 days beyond cessation 
of clinical signs of disease up to a maximum of 30 days. 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]



Sec.  520.763  Dithiazanine iodide oral dosage forms.



Sec.  520.763a  Dithiazanine iodide tablets.

    (a) Chemical name. 3-Ethyl-2-[5-(3-ethyl - 2 - 
benzothiazolinylidene) - 1,3 - pentadienyl]-benzothiazolium iodide.
    (b) Specifications. Dithiazanine iodide tablets contain 10 
milligrams, 50 milligrams, 100 milligrams, or 200 milligrams of 
dithiazanine iodide in each tablet.
    (c) Sponsor. See No. 000010 in Sec.  510.600(c) of this chapter.
    (d) Conditions of use. (1) The tablets are administered orally to 
dogs immediately after feeding using the following dosage schedule for 
various parasite infestations:

------------------------------------------------------------------------
                                             Milligrams
                                              per pound     Length of
                                               of body   treatment--days
                                               weight
------------------------------------------------------------------------
Large roundworms (Toxocara canis,                    10            3-5
 Toxascaris leonina).......................
Hookworms (Ancylostoma caninum, Uncinaria            10              7
 stenocephala).............................
Whipworms (Trichuris vulpis)...............          10
Strongyloides (Strongyloides canis,                  10          10-12
 Strongyloides stercoralis)................
Heartworm microfilariae (Dirofilaria                3-5           7-10
 immitus)..................................
------------------------------------------------------------------------
Note: Treatment with dithiazanine iodide for heartworm microfilariae
  should follow 6 weeks after therapy for adult worms.

    (2) The drug is contraindicated in animals sensitive to dithiazanine 
iodide and should be used cautiously, if at all, in dogs with reduced 
renal function.
    (3) Federal law restricts this drug to use by or on the order of a 
licensed veterinarian.
    (e) Use for treating dogs for large roundworms, hookworms, 
whipworms, and strongyloides as provided for in

[[Page 131]]

this section has been NAS/NRC reviewed and deemed effective. 
Applications for these uses need not include effectiveness data as 
specified by Sec.  514.111 of this chapter, but may require 
bioequivalency and safety information.

[40 FR 13838, Mar. 27, 1975, as amended at 47 FR 51564, Nov. 16, 1982; 
48 FR 32342, July 15, 1983; 53 FR 40727, Oct. 18, 1988; 62 FR 35076, 
June 30, 1997]



Sec.  520.763b  Dithiazanine iodide powder.

    (a) Chemical name. 3-Ethyl-2-[5-(3-ethyl-2-benzothiazolinylidene)-
1,3-pentadienyl]-benzothiazoliumiodide.
    (b) Specifications. Dithiazanine iodide powder contains 200 
milligrams of dithiazanine iodide per level standard tablespoon.
    (c) Sponsor. See No. 000010 in Sec.  510.600(c) of this chapter.
    (d) Conditions of use. (1) Dithiazanine iodide powder is 
administered to dogs by mixing the proper dosage in the dog's food, 
using the following dosage schedule for various parasite infestations:

------------------------------------------------------------------------
                                             Milligrams
                                              per pound     Length of
                                               of body   treatment--days
                                               weight
------------------------------------------------------------------------
Large roundworms (Toxocara canis,                    10            3-5
 Toxascaris leonina).......................
Hookworms (Ancylostoma caninum, Uncinaria            10              7
 stenocephala).............................
Whipworms (Trichuris vulpis)...............          10              7
Strongyloides (Strongyloides canis,                  10          10-12
 Strongyloides stercoralis)................
Heartworm microfilariae (Dirofilaria                3-5           7-10
 immitus)..................................
------------------------------------------------------------------------
Note: Treatment with dithiazanine iodide for heartworm microfilariae
  should follow 6 weeks after therapy for adult worms.

    (2) The drug is contraindicated in animals sensitive to dithiazanine 
iodide and should be used cautiously, if at all, in dogs with reduced 
renal function.
    (3) Federal law restricts this drug to use by or on the order of a 
licensed veterinarian.
    (e) Use for treating dogs for large roundworms, hookworms, 
whipworms, and strongyloides as provided for in this section has been 
NAS/NRC reviewed and deemed effective. Applications for these uses need 
not include effectiveness data as specified by Sec.  514.111 of this 
chapter, but may require bioequivalency and safety information.

[40 FR 13838, Mar. 27, 1975, as amended at 47 FR 51564, Nov. 16, 1982; 
48 FR 32342, July 15, 1983; 53 FR 40727, Oct. 18, 1988; 62 FR 35076, 
June 30, 1997]



Sec.  520.763c  Dithiazanine iodide and piperazine citrate suspension.

    (a) Specifications. Each milliliter of the drug contains 69 
milligrams of dithiazanine iodide and 83 milligrams of piperazine base 
(as piperazine citrate).
    (b) Sponsor. See 000010 in Sec.  510.600(c) of this chapter.
    (c) NAS/NRC status. The conditions of use are NAS/NRC reviewed and 
found effective. Applications for these uses need not include 
effectiveness data as specified by Sec.  514.111 of this chapter, but 
may require bioequivalency and safety information.
    (d) Conditions of use--(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]



Sec.  520.784  Doxylamine succinate tablets.

    (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.

[[Page 132]]

    (c) Conditions of use. (1) The drug is used in conditions in which 
antihistaminic therapy may be expected to alleviate some signs of 
disease in horses, dogs, and cats. \1\
---------------------------------------------------------------------------

    \1\ These conditions are NAS/NRC reviewed and deemed effective. 
Applications for these uses need not include effectiveness data as 
specified by Sec.  514.111 of this chapter.
---------------------------------------------------------------------------

    (2) It is administered orally to horses at a dosage level of 1 to 2 
milligrams per pound of body weight per day divided into 3 or 4 equal 
doses. It is administered orally to dogs and cats at a dosage level of 2 
to 3 milligrams per pound of body weight per day divided into 3 or 4 
equal doses. \1\
    (3) Not for use in horses intended for food. \1\
    (4) Federal law restricts this drug to use by or on the order of a 
licensed veterinarian. \1\

[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]



Sec.  520.804  Enalapril tablets.

    (a) Specifications. Each tablet contains either 1.0, 2.5, 5.0, 10.0, 
or 20.0 milligrams of enalapril maleate.
    (b) Sponsor. See 050604 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use--(1) Dogs--(i) Amount. 0.5 to 1.0 milligram of 
enalapril maleate per kilogram of body weight per day.
    (ii) Indications for use. Treatment of mild, moderate, and severe 
(modified New York Heart Association Class II, III, IV) heart failure in 
dogs.
    (iii) Limitations. Use 0.5 milligram per kilogram once daily. In the 
absence of adequate clinical response within a 2-week period, use may be 
increased to twice daily (a total of 1.0 milligram per kilogram). 
Enalapril maleate is administered as conjunctive therapy with furosemide 
and digoxin in the treatment of dilated cardiomyopathy and furosemide 
with or without digoxin in the treatment of chronic valvular disease. 
The safety of enalapril for use in breeding dogs has not been 
established. Use in pregnant bitches is not recommended. Federal law 
restricts this drug to use by or on the order of a licensed 
veterinarian.
    (2) [Reserved]

[59 FR 17694, Apr. 14, 1994, as amended at 62 FR 63270, Nov. 28, 1997]



Sec.  520.812  Enrofloxacin tablets.

    (a) Specifications. Each tablet contains either 22.7, 68.0, or 136.0 
milligrams of enrofloxacin.
    (b) Sponsor. See No. 000859 in Sec.  510.600(c) of this chapter.
    (c) [Reserved]
    (d) Conditions of use--(1) Amount. 5 to 20 milligrams per kilogram 
(2.27 to 9.07 milligrams per pound) of body weight.
    (2) Indications for use. Dogs and cats for management of diseases 
associated with bacteria susceptible to enrofloxacin.
    (3) Limitations. Administer orally as a single dose or divided into 
2 equal doses at 12 hour intervals, daily. Administer for at least 2 to 
3 days beyond cessation of clinical symptoms, for a maximum of 30 days. 
Safety in breeding or pregnant cats has not been established. Federal 
law restricts this drug to use by or on the order of a licensed 
veterinarian.

[54 FR 3444, Jan. 24, 1989, as amended at 55 FR 43327, Oct. 29, 1990; 62 
FR 38906, July 21, 1997; 64 FR 48295, Sept. 3, 1999]



Sec.  520.813  Enrofloxacin oral solution.

    (a) Specifications. Each milliliter of concentrate solution contains 
32.3 milligrams of enrofloxacin.
    (b) Sponsor. See No. 000859 in Sec.  510.600(c) of this chapter.
    (c) Related tolerances. See Sec.  556.228 of this chapter.
    (d) Conditions of use. It is used in drinking water as follows:
    (1) Chickens and turkeys--(i) Amount. 25 to 50 parts per million of 
enrofloxacin in drinking water.
    (ii) Indications. Chickens: Control of mortality associated with 
Escherichia coli susceptible to enrofloxacin. Turkeys: Control of 
mortality associated with E. coli and Pasteurella multocida (fowl 
cholera) susceptible to enrofloxacin.
    (iii) Limitations. Do not use in laying hens producing eggs for 
human consumption. Administer medicated water continuously as sole 
source of drinking water for 3 to 7 days. Prepare fresh stock solution 
daily. Effects on the reproductive function of turkeys have

[[Page 133]]

not been determined. Treated animals must not be slaughtered for food 
within 2 days of the last treatment. Individuals with a history of 
hypersensitivity to quinolones should avoid exposure to this product. 
Federal law restricts this drug to use by or on the order of a licensed 
veterinarian.
    (2) [Reserved]

[61 FR 56893, Nov. 5, 1996]



Sec.  520.816  Epsiprantel tablets.

    (a) Specifications. Each tablet contains either 12.5, 25, 50, or 100 
milligrams of epsiprantel.
    (b) Sponsor. See No. 000069 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. For oral use only as a single dose. Do not use in 
animals less than 7 weeks of age. Safety of use in pregnant or breeding 
animals has not been established. 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]



Sec.  520.823  Erythromycin phosphate.

    (a) Specifications. Erythromycin phosphate is the phosphate salt of 
the antibiotic substance produced by the growth of Streptomyces 
erythreus or the same antibiotic substance produced by any other means. 
One gram of erythromycin phosphate is equivalent to 0.89 gram of 
erythromycin master standard.
    (b) Sponsor. See No. 061623 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. 0.500 gram per 
gallon.
    (ii) Indications for use. As an aid in the control of chronic 
respiratory disease due to Mycoplasma gallisepticum susceptible to 
erythromycin.
    (iii) Limitations. Administer for 5 days; do not use in replacement 
pullets over 16 weeks of age; do not use in chickens producing eggs for 
human consumption; to assure effectiveness, treated birds must consume 
enough medicated water to provide a therapeutic dosage; solutions older 
than 3 days should not be used; withdraw 1 day before slaughter.
    (2) Replacement chickens and chicken breeders--(i) Amount. 0.500 
gram per gallon.
    (ii) Indications for use. As an aid in the control of infectious 
coryza due to Hemophilus gallinarum susceptible to erythromycin.
    (iii) Limitations. Administer for 7 days; do not use in replacement 
pullets over 16 weeks of age; do not use in chickens producing eggs for 
human consumption; to assure effectiveness, treated birds must consume 
enough medicated water to provide a therapeutic dosage; solutions older 
than 3 days should not be used; withdraw 1 day before slaughter.
    (3) Growing turkeys--(i) Amount. 0.500 gram per gallon.
    (ii) Indications for use. As an aid in the control of blue comb 
(nonspecific infectious enteritis) caused by organisms susceptible to 
erythromycin.
    (iii) Limitations. Administer for 7 days; do not use in turkeys 
producing eggs for human consumption; to assure effectiveness, treated 
birds must consume enough medicated water to provide a therapeutic 
dosage; solutions older than 3 days should not be used; withdraw 1 day 
before slaughter.

[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]



Sec.  520.863  Ethylisobutrazine hydrochloride tablets.

    (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.

[[Page 134]]

    (c) Conditions of use. (1) It is administered orally to dogs as a 
tranquilizer.\1\
---------------------------------------------------------------------------

    \1\ These conditions are NAS/NRC reviewed and deemed effective. 
Applications for these uses need not include effectiveness data as 
specified by Sec.  514.111 of this chapter, but may require 
bioequivalency and safety information.
---------------------------------------------------------------------------

    (2) It is administered once daily at a dosage level of 2 to 5 
milligrams of ethylisobutrazine hydrochloride per pound of body 
weight.\1\
    (3) It is not to be used in conjunction with organophosphates and/or 
procaine hydrochloride because phenothiazine may potentiate the toxicity 
of organophosphates and the activity of procaine hydrochloride.\1\
    (4) Federal law restricts this drug to use by or on the order of a 
licensed veterinarian.\1\

[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]



Sec.  520.870  Etodolac.

    (a) Specifications. Each tablet contains 150 or 300 milligrams (mg) 
of etodolac.
    (b) Sponsor. See 053501 in Sec.  510.600(c) of this chapter.
    (c) [Reserved]
    (d) Conditions of use--(1) Dogs--(i) Amount. 10 to 15 mg per 
kilogram (4.5 to 6.8 mg/pound) of body weight per day.
    (ii) Indications for use. For the management of pain and 
inflammation associated with osteoarthritis in dogs.
    (iii) Limitations. Use once-a-day. Federal law restricts this drug 
to use by or on the order of a licensed veterinarian.
    (2) [Reserved]

[63 FR 51300, Sept. 25, 1998]



Sec.  520.903  Febantel oral dosage forms.



Sec.  520.903a  Febantel paste.

    (a) Chemical name. Dimethyl [[2-[(methoxyacetyl)amino]-4-(phenyl-
thio)phenyl] carbonimidoyl]bis [carbamate].
    (b) Specifications. The drug is a paste containing 45.5 percent 
febantel.
    (c) Sponsor. See No. 000859 in Sec.  510.600(c) of this chapter.
    (d) Conditions of use--(1) Amount. Six milligrams per kilogram (2.73 
milligrams per pound) of body weight in horses.
    (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 the various small strongyles in horses, foals, and 
ponies.
    (3) Limitations. (i) The paste may be administered on the base of 
the tongue or well mixed into a portion of the normal grain ration.
    (ii) [Reserved]
    (iii) 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.
    (iv) Not for use in horses intended for food.
    (v) Consult your veterinarian for assistance in the diagnosis, 
treatment, and control of parasitism.

[43 FR 8797, Mar. 3, 1978; 43 FR 12311, Mar. 24, 1978, as amended at 43 
FR 60882, Dec. 29, 1978. Redesignated at 45 FR 8587, Feb. 8, 1980]



Sec.  520.903b  Febantel suspension.

    (a) Specifications. The suspension contains 9.3 percent (2.75 grams 
per ounce) febantel.
    (b) Sponsor. See 000859 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use--(1) Amount. 3 milliliters per 100 pounds body 
weight or 1 fluid ounce per 1000 pounds (6 milligrams per kilogram body 
weight).
    (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 the various small strongyles in horses, breeding 
stallions and mares, pregnant mares, foals, and ponies.
    (3) Limitations. 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. Not for 
use in horses intended for food. Federal law restricts this drug to use 
by or on the order of a licensed veterinarian.

[[Page 135]]

    (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]



Sec.  520.903c  [Reserved]



Sec.  520.903d  Febantel-praziquantel paste.

    (a) Specifications. Each gram of paste contains 34 milligrams of 
febantel and 3.4 milligrams of praziquantel.
    (b) Sponsor. See No. 000859 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. Do not use in pregnant animals. Federal law 
restricts this drug to use by or on the order of a licensed 
veterinarian.
    (4) Special considerations. Consider alternative therapy or use with 
caution in animals with pre-existing liver or kidney dysfunction.

[50 FR 19167, May 7, 1985, as amended at 53 FR 48533, Dec. 1, 1988; 56 
FR 50813, Oct. 9, 1991]



Sec.  520.903e  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 000859 in Sec.  510.600(c)(2) 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.
    (ii) For removal of hookworms (Ancylostoma tubaeforme) and ascarids 
(Toxocara cati) in cats and kittens.
    (3) Limitations. Do not use in pregnant animals. Consider 
alternative therapy or use with caution in animals with preexisting 
liver or kidney dysfunction. Administer to puppies and kittens on a full 
stomach. Federal law restricts this drug to use by or on the order of a 
licensed veterinarian.

[56 FR 50655, Oct. 8, 1991]



Sec.  520.905  Fenbendazole oral dosage forms.



Sec.  520.905a  Fenbendazole suspension.

    (a) Specifications. The drug is a suspension containing 10 percent 
(100 milligrams per milliliter) fenbendazole.
    (b) Sponsor. See No. 057926 in Sec.  510.600(c) of this chapter.
    (c) Related tolerances. See Sec.  556.275 of this chapter.
    (d) Conditions of use--(1) Horses--(i) Amount. 5 milligrams per 
kilogram (2.3 milligrams per pound) for the control of large strongyles, 
small strongyles, and pinworms; 10 milligrams per kilogram for the 
control of ascarids.

[[Page 136]]

    (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 orally by dose syringe or suitable 
plastic syringe. Do not use in horses intended for food. Consult a 
veterinarian for assistance in the diagnosis, treatment, and control of 
parasitism.
    (2) Cattle including dairy cows of breeding age--(i) Amount. 
Administer orally 5 milligrams per kilogram of body weight (2.3 
milligrams per pound).
    (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. Retreatment may be needed after 4 to 6 weeks. 
Cattle must not be slaughtered within 8 days following last treatment. 
Consult a veterinarian for assistance in the diagnosis, treatment, and 
control of parasitism.
    (3) Beef cattle--(i) Amount. Administer orally 10 milligrams per 
kilogram of body weight.
    (ii) For the removal and control of stomach worm (4th-stage 
inhibited larvae/type II ostertagiasis), Ostertagia ostertagi, and 
tapeworm, Moniezia benedeni.
    (iii) Limitations. Retreatment may be needed after 4 to 6 weeks. 
Cattle must not be slaughtered within 8 days following last treatment. 
Federal law restricts this drug to use by or on the order of a licensed 
veterinarian.
    (4) Goats--(i) Amount. Administer orally 5 milligrams per kilogram 
of body weight (2.3 milligrams per pound).
    (ii) Indications for use. For the removal and control of stomach and 
intestinal worms Haemonchus contortus and Ostertagia circumcincta.
    (iii) Limitations. Retreatment may be needed after 4 to 6 weeks. 
Goats must not be slaughtered for food within 6 days following last 
treatment. Do not use in lactating goats. Federal law restricts this 
drug to use by or on the order of a licensed veterinarian.
    (e) Special considerations. Fenbendazole suspension 10 percent and 
approved forms of trichlorfon, when used concomitantly for treating the 
indications provided in paragraph (d) 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.

[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]



Sec.  520.905b  Fenbendazole granules.

    (a) Specifications. Each gram of granules contains 222 milligrams 
(mg) fenbendazole.
    (b) Sponsor. See No. 057926 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.

[[Page 137]]

    (ii) Indications for use. For the removal 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. 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]



Sec.  520.905c  Fenbendazole paste.

    (a) Specifications. The product is an aqueous paste containing 10 
percent fenbendazole.
    (b) Sponsor. See No. 057926 in Sec.  510.600(c) of this chapter.
    (c) Related tolerances. See Sec.  556.275 of this chapter.
    (d) Conditions of use--(1) Horses--(i)(a) Amount. 2.3 milligrams per 
pound of body weight (one 2.5-gram fenbendazole syringe for a 1,100-
pound horse). For foals and weanlings (less than 18 months of age), 4.6 
milligrams per pound of body weight (one 2.5-gram fenbendazole syringe 
for each 550 pounds of body weight).
    (b) Indications for use. For control of large strongyles (Strongylus 
edentatus, S. equinus, S. vulgaris), small strongyles, pinworms (Oxyuris 
equi), and ascarids (Parascaris equorum) in horses.
    (c) Limitations. Retreatment at intervals of 6 to 8 weeks may be 
required. Do not use in horses intended for food. Consult your 
veterinarian for assistance in the diagnosis, treatment, and control of 
parasitism.
    (ii)(a) Amount. 4.6 milligrams per pound of body weight (one 2.5-
gram fenbendazole syringe for a 550-pound horse) daily for 5 days.
    (b) Indications for use. For control of arteritis caused by the 
fourth stage larvae of Strongylus vulgaris.
    (c) Limitations. Treatment should be initiated in the spring and 
repeated in 6 months. Do not use in horses intended for food. Consult 
your veterinarian for assistance in the diagnosis, treatment, and 
control of fourth stage larvae of S. vulgaris.
    (iii)(a) Amount. 4.6 milligrams per pound of body weight (10 
milligrams per kilogram) daily for 5 consecutive days.
    (b) Indications for use. For treatment of encysted mucosal 
cyathostome (small strongyle) larvae including early third stage 
(hypobiotic), late third stage, and fourth stage larvae in horses.
    (c) Limitations. (Consult your veterinarian for assistance in the 
diagnosis, treatment, and control of encysted mucosal cyathostomes). Do 
not use in horses intended for food.
    (2) Beef and dairy cattle--(i) Amount. Administer orally 5 
milligrams per kilogram of body weight (2.3 milligrams per pound).
    (ii) Indications for use. For the removal and control of lungworm 
(Dictyocaulus viviparus), barberpole

[[Page 138]]

worm (Haemonchus contortus), brown stomach worm (Ostertagia ostertagi), 
small stomach worm (Trichostrongylus axei), hookworm (Bunostomum 
phlebotomum), thread-necked intestinal worm (Nematodirus helvetianus), 
small intestinal worms (Cooperia punctata and C. oncophora), bankrupt 
worm (Trichostrongylus colubriformis), and nodular worm (Oesophagostomum 
radiatum).
    (iii) Limitations. Re-treatment may be needed after 4 to 6 weeks. 
Cattle must not be slaughtered within 8 days following last treatment. 
Consult a veterinarian for assistance in the diagnosis, treatment, and 
control of parasitism.
    (e) Special considerations. Fenbendazole paste 10 percent may be 
used concomitantly with approved forms of trichlorfon for the 
indications provided in paragraph (d)(1)(i) of this section and for 
treating infections of stomach bots as provided in Sec.  520.2520.

[46 FR 32018, June 19, 1981, as amended at 47 FR 15327, Apr. 9, 1982; 49 
FR 8433, Mar. 7, 1984; 50 FR 26358, June 26, 1985; 61 FR 29478, June 11, 
1996; 63 FR 31624, June 10, 1998; 66 FR 47960, Sept. 17, 2001]



Sec.  520.905d  Fenbendazole powder.

    (a) Specifications. (1) Each 2-ounce packet contains 2.27 grams (4 
percent) of fenbendazole plus other inert ingredients.
    (2) Each 4-ounce packet contains 1.7 grams (1.5 percent) of 
fenbendazole plus other inert ingredients.
    (b) Sponsors. (1) See No. 057926 in Sec.  510.600(c) of this chapter 
for use of the 4-percent product.
    (2) See No. 017800 in Sec.  510.600(c) of this chapter for use of 
the 1.5-percent product.
    (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]



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.
    (b) Sponsor. See 057926 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

[[Page 139]]

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]



Sec.  520.955  Florfenicol.

    (a) Specifications. Each milliliter (mL) contains 23 milligrams (mg) 
florfenicol.
    (b) Sponsor. See No. 000061 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 
Type 2.
    (3) Limitations. Do not slaughter within 16 days of last treatment. 
Federal law restricts this drug to use by or on the order of a licensed 
veterinarian.

[67 FR 78357, Dec. 24, 2002]



Sec.  520.960  Flumethasone tablets.

    (a) Specifications. Each tablet contains 0.0625 milligram of 
flumethasone.
    (b) Sponsor. See No. 000856 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. Do not use in viral infections. Anti-inflammatory 
action of corticosteroids may mask signs of infection. Do not use in 
animals with tuberculosis, chronic nephritis, cushingoid syndrome, or 
where peptic ulcers occur, except for emergency therapy. Clinical and 
experimental data have demonstrated that corticosteroids administered 
orally or parenterally to animals may induce the first stage of 
parturition when administered during last trimester of pregnancy and may 
precipitate premature parturition followed by dystocia, fetal death, 
retained placenta, and metritis. 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]



Sec.  520.970  Flunixin oral dosage forms.



Sec.  520.970a  Flunixin meglumine granules.

    (a) Specifications. Each 10-gram packet contains flunixin meglumine 
equivalent to 250 milligrams of flunixin.
    (b) Sponsor. No. 000061 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use--(1) Amount. 0.5 milligram of flunixin per 
pound of body weight (one packet per 500 pounds) per day.
    (2) Indications for use. For alleviation of inflammation and pain 
associated with musculoskeletal disorders in the horse.
    (3) Limitations. Administer daily dose for up to 5 days by 
sprinkling on small amount of feed. The effect of this drug on pregnancy 
has not been determined. Not for use in horses intended for food. 
Federal law restricts this drug to use by or on the order of a licensed 
veterinarian.

[44 FR 36381, June 22, 1979. Redesignated at 50 FR 38114, Sept. 20, 
1985, and amended at 52 FR 7832, Mar. 13, 1987]



Sec.  520.970b  Flunixin meglumine paste.

    (a) Specifications. Each 30-gram syringe contains flunixin meglumine 
equivalent to 1,500 milligrams of flunixin.
    (b) Sponsor. No. 000061 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use. Horses--(1) Amount. 0.5 milligram of flunixin 
per pound of body weight daily.

[[Page 140]]

    (2) Indications for use. For alleviation of inflammation and pain 
associated with musculoskeletal disorders.
    (3) Limitations. For oral use only. Treatment should not exceed 5 
consecutive days. The effect of this drug on pregnancy has not been 
determined. Not for use in horses intended for food. Federal law 
restricts this drug to use by or on the order of a licensed 
veterinarian.

[50 FR 38114, Sept. 20, 1985, as amended at 52 FR 7832, Mar. 13, 1987]



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. 000093 for tablets in paragraph (a)(1) of this section for 
conditions of use in paragraphs (d)(2)(i) and (d)(2)(ii)(B) of this 
section.
    (3) No. 057926 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).
    (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]



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 051259 in Sec.  510.600(c) of this 
chapter.
    (c) Related tolerances. See Sec.  556.300 of this chapter.
    (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. For use in swine drinking water only. Do not store 
or offer medicated drinking water in

[[Page 141]]

rusty containers since the drug is quickly destroyed in such containers. 
Medicated drinking water should be prepared daily and be the sole source 
of drinking water for 3 consecutive days. Treatment may be repeated if 
dysentery recurs. Do not slaughter treated swine for food for at least 3 
days following treatment.

[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]



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 059130 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]



Sec.  520.1044c  Gentamicin sulfate soluble powder.

    (a) Specifications. Each gram of gentamicin sulfate soluble powder 
contains gentamicin sulfate equivalent to 16.7, 66.7, or 333.3 
milligrams of gentamicin.
    (b) Sponsor. See Nos. 000061 and 057561 in Sec.  510.600(c) of this 
chapter.
    (c) Related tolerances. See Sec.  556.300 of this chapter.
    (d) Conditions of use--(1) Amount. Colibacillosis: gentamicin 
sulfate equivalent to 25 milligrams of gentamicin per gallon of drinking 
water for 3 consecutive days, to provide 0.5 milligram per pound of body 
weight per day; swine dysentery: gentamicin sulfate equivalent to 50 
milligrams of gentamicin per gallon of drinking water for 3 consecutive 
days, to provide 1 milligram per pound of body weight per 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. For use in swine drinking water only. Do not store 
or offer medicated drinking water in rusty containers since the drug is 
quickly destroyed in such containers. Medicated drinking water should be 
prepared daily and be the sole source of drinking water for 3 
consecutive days. Treatment may be repeated if dysentery recurs. Do not 
slaughter treated swine for food for at least 10 days following 
treatment.

[49 FR 29778, July 24, 1984, as amended at 52 FR 7832, Mar. 13, 1987; 52 
FR 48675, Dec. 24, 1987; 62 FR 29013, May 29, 1997]



Sec.  520.1100  Griseofulvin.

    (a) Chemical name. 7-Chloro-2',4,6-trimethoxy-6'-methylspiro 
[benzofuran-2(3H), 1'-[2]-cyclohexene]-3,4'-dione.
    (b) Specifications. Complies with U.S.P. for griseofulvin microsize.
    (c) Sponsor. See No. 000061 in Sec.  510.600(c) of this chapter.
    (d) Conditions of use. (1) As a soluble powder for horses, it is 
administered as a drench or as a top dressing on feed. It is used for 
equine ringworm infection caused by Trichophyton equinum or Microsporum 
gypseum. Administer for not less than 10 days a daily dose as follows: 
Adults, 2.5 grams; yearlings, 1.25 to 2.5 grams; and foals, 1.25 grams. 
Not for use in horses intended for food. For use only by or on the order 
of a licensed veterinarian.
    (2)(i) Boluses containing 2.5 grams of griseofulvin are used in 
horses for treating ringworm infection caused by Trichophyton equinum. 
It is administered to adult horses at a level of one bolus per day, to 
yearlings at one-half to one bolus per day, and to foals at one-half 
bolus per day. All three dosage levels should be administered for a 
period of not less than 10 days. In responsive cases, treatment should 
be continued until all infected areas are proven

[[Page 142]]

negative by appropriate culture. Not for use in horses intended for 
food.
    (ii) Federal law restricts this drug to use by or on the order of a 
licensed veterinarian.
    (3) Dogs and cats: (i) Amount. 125- and 500-milligram tablets 
administered orally as follows:
    (a) Daily (single or divided) dose:

------------------------------------------------------------------------
                                                               Dosage
                   Body weight (pounds)                     (milligrams)
------------------------------------------------------------------------
Up to 6...................................................         62.5
6 to 18...................................................          125
18 to 36..................................................          250
36 to 48..................................................          375
48 to 75..................................................          500
------------------------------------------------------------------------

    (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 floccosum, Microsporum gypseum, M. canis, M. audouini.
    (iii) Limitations. For satisfactory diagnosis, a microscopic tissue 
examination or culture is recommended prior to treatment. Treatment 
should be continued for 3 to 4 weeks in skin and hair infections, and up 
to 4 months for infections involving nails or claws. Clipping of hair, 
nails, and claws to help remove any remaining viable fungi is indicated. 
Safety for use of griseofulvin for pregnant animals has not been 
established. 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 42948, Sept. 29, 1976; 
43 FR 28458, June 30, 1978; 52 FR 7832, Mar. 13, 1987; 54 FR 30205, July 
19, 1989]



Sec.  520.1120  Haloxon oral dosage forms.



Sec.  520.1120a  Haloxon drench.

    (a) Chemical name. 3-Choloro-7-hydoxy-4-methylcoumarin bis (2-
chloroethyl) phosphate.
    (b) Specifications. Haloxon assay of not less than 96 percent by 
infrared spectrum at 8.62 microns.
    (c) Sponsor. See No. 000061 in Sec.  510.600(c) of this chapter.
    (d) 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.
    (e) Related tolerances. See Sec.  556.310 of this chapter.
    (f) Conditions of use. It is used as a drench as follows:
    (1) Cattle --(i) Amount. 141.5 grams per packet.
    (ii) Indications for use. Control of gastrointestinal roundworms of 
the genera Haemonchus, Ostertagia, Trichostrongylus, and Cooperia.
    (iii) Limitations. (a) Dissolve each packet in 32 fluid ounces of 
water and administer as follows:

------------------------------------------------------------------------
                                                                 Dose
                  Weight of animal (pounds)                     (fluid
                                                                ounces)
------------------------------------------------------------------------
Up to 100...................................................       \1/2\
100 to 150..................................................       \3/4\
150 to 200..................................................           1
200 to 300..................................................      1\1/2\
300 to 450..................................................           2
450 to 700..................................................           3
700 to 1,000................................................           4
1,000 to 1,200..............................................           5
Over 1,200..................................................           6
------------------------------------------------------------------------

    (b) Do not treat within 1 week of slaughter; do not treat dairy 
animals of breeding age; animals should be retreated in 3 to 4 weeks.

[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]



Sec.  520.1120b  Haloxon boluses.

    (a) Chemical name. 3-Chloro-7-hydroxy-4-methylcoumarin bis (2-
chloroethyl) phosphate.
    (b) Specifications. Each bolus contains 10.1 grams of haloxon.
    (c) Sponsor. See No. 000061 in Sec.  510.600(c) of this chapter.
    (d) Related tolerances. See Sec.  556.310 of this chapter.
    (e) Conditions of use. (1) Haloxon bolus is an anthelmintic used in 
cattle for the control of gastrointestinal roundworms of the genera 
Haemonchus,

[[Page 143]]

Ostertagia, Trichostrongylus and Cooperia.
    (2) It is administered by giving one bolus per approximately 500 
pounds body weight (35 to 50 milligrams per kilogram of body weight).
    (3) For most effective results, re-treat animals in 3 to 4 weeks. If 
reinfection is likely to occur, additional re-treatments may be 
necessary.
    (4) Do not use any drug, pesticide or other chemical having 
cholinesterase inhibiting activity either simultaneously or within a few 
days before or after treatment with haloxon.
    (5) Do not treat animals within one week of slaughter.
    (6) Do not treat dairy animals of breeding age or older.

[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]



Sec.  520.1130  Hetacillin oral dosage forms.



Sec.  520.1130a  Hetacillin potassium capsules.

    (a) Specifications. Each capsule contains hetacillin potassium 
equivalent to 50, 100, or 200 milligrams of ampicillin.
    (b) Sponsor. See No. 000856 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use. (1) Dogs--(i) Amount. 5 milligrams per pound 
of body weight, twice daily. In severe infections, up to three times 
daily, or up to 10 milligrams per pound of body weight twice daily. For 
stubborn urinary tract infections, up to 20 milligrams per pound of body 
weight twice daily.
    (ii) Indications for use. Treatment against strains of organisms 
sensitive to hetacillin potassium and associated with respiratory tract 
infections, urinary tract infections, gastrointestinal infections, skin 
infections, soft tissue infections, and postsurgical infections.
    (iii) Limitations. For use in dogs and cats only. Continue treatment 
for 48 to 72 hours after the animal has become afebrile or asymptomatic. 
Administer 1 to 2 hours prior to feeding to ensure maximum absorption. 
In stubborn infections, therapy may be required for several weeks. Not 
for use in animals raised for food production. Federal law restricts 
this drug to use only by or on the order of a licensed veterinarian.
    (2) Cats--(i) Amount. Administer 50 milligrams twice daily.
    (ii) Indications for use. Treatment against strains of organisms 
sensitive to hetacillin potassium and associated with respiratory tract 
infections, urinary tract infections, gastrointestinal infections, skin 
infections, soft tissue infections, and postsurgical infections.
    (3) Limitations. For use in dogs and cats only. Continue treatment 
for 48 to 72 hours after the animal has become afebrile or asymptomatic. 
Administer in a fasting state to ensure maximum absorption. In stubborn 
infections, therapy may be required for several weeks. Not for use in 
animals raised for food production. Federal law restricts this drug to 
use only by or on the order of a licensed veterinarian.

[57 FR 37325, Aug. 18, 1992]



Sec.  520.1130b  Hetacillin potassium oral suspension.

    (a) Specifications. Each milliliter contains hetacillin potassium 
equivalent to 50 milligrams of ampicillin.
    (b) Sponsor. See No. 000856 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use--(1) Dogs--(i) Amount. 5 milligrams per pound 
of body weight twice daily. In severe infections, up to three times 
daily, or up to 10 milligrams per pound of body weight twice daily. For 
stubborn urinary tract infections, up to 20 milligrams per pound of body 
weight twice daily.
    (ii) Indications for use. Treatment against strains of organisms 
susceptible to hetacillin potassium and associated with respiratory 
tract infections, urinary tract infections, gastrointestinal infections, 
skin infections, soft-tissue infections, and postsurgical infections.
    (iii) Limitations. For use in dogs only. Not for use in animals 
raised for food production. Continue treatment 48 to 72 hours after the 
animal has become afebrile or asymptomatic. Administer 1 to 2 hours 
prior to feeding to ensure maximum absorption. In stubborn infections, 
therapy may be required for several weeks. Federal law restricts this 
drug to use by or on the order of a licensed veterinarian.

[[Page 144]]

    (2) Cats--(i) Amount. 50 milligrams twice daily.
    (ii) Indications for use. Treatment against strains of organisms 
susceptible to hetacillin potassium and associated with respiratory 
tract infections, urinary tract infections, gastrointestinal infections, 
skin infections, soft-tissue infections, and postsurgical infections.
    (iii) Limitations. For use in cats only. Not for use in animals 
raised for food production. Continue treatment 48 to 72 hours after the 
animal has become afebrile or asymptomatic. Administer 1 to 2 hours 
prior to feeding to ensure maximum absorption. In stubborn infections, 
therapy may be required for several weeks. Federal law restricts this 
drug to use by or on the order of a licensed veterinarian.

[57 FR 37326, Aug. 18, 1992]



Sec.  520.1130c  Hetacillin potassium tablets.

    (a) Specifications. Each tablet contains hetacillin potassium 
equivalent to 50, 100, or 200 milligrams of ampicillin.
    (b) Sponsor. See No. 000856 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use--(1) Dogs--(i) Amount. 5 milligrams per pound 
of body weight twice daily. In severe infections, up to three times 
daily, or up to 10 milligrams per pound of body weight twice daily. For 
stubborn urinary tract infections, up to 20 milligrams per pound of body 
weight twice daily.
    (ii) Indications for use. Oral treatment against strains of 
organisms sensitive to hetacillin potassium and associated with 
respiratory tract infections, urinary tract infections, gastrointestinal 
infections, skin infections, soft tissue infections, and postsurgical 
infections.
    (iii) Limitations. For use in dogs and cats only. Continue treatment 
for 48 to 72 hours after the animal has become afebrile or asymptomatic. 
Administer 1 to 2 hours prior to feeding to ensure maximum absorption. 
In stubborn infections, therapy may be required for several weeks. 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) Cats--(i) Amount. 50 milligrams twice daily.
    (ii) Indications for use. Treatment against strains of organisms 
sensitive to hetacillin potassium and associated with respiratory tract 
infections, urinary tract infections, gastrointestinal infections, skin 
infections, soft tissue infections, and postsurgical infections.
    (iii) Limitations. For use in dogs and cats only. Continue treatment 
for 48 to 72 hours after the animal has become afebrile or asymptomatic. 
Administer 1 to 2 hours prior to feeding to ensure maximum absorption. 
In stubborn infections, therapy may be required for several weeks. 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.

[57 FR 37326, Aug. 18, 1992]



Sec.  520.1157  Iodinated casein tablets.

    (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. If no response is observed in 30 to 45 days, the 
drug should be withdrawn and the diagnosis reconsidered. Do not use in 
the presence of cardiac disease, ischemia, adrenal insufficiency, or 
nephrosis. Federal law restricts this drug to use by or on the order of 
a licensed veterinarian.

[49 FR 22469, May 30, 1984]



Sec.  520.1158  Iodochlorhydroxyquin boluses.

    (a) Specifications. Each bolus contains 10 grams of 
iodochlorhydroxyquin.
    (b) Sponsor. See No. 053501 in Sec.  510.600(c) of this chapter.

[[Page 145]]

    (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. For horses only; not to be administered to food-
producing animals. Do not administer to horses intended for use as food. 
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]



Sec.  520.1182  Iron dextran oral suspension.

    (a) Specifications. Each 1.8 milliliter contains 100 milligrams of 
elemental iron as ferric hydroxide in complex with a low molecular 
weight dextran and 0.2 percent phenol as a preservative.
    (b) Sponsor. See 017800 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use--(1) Amount. 100 milligrams of elemental iron 
to each pig.
    (2) Indications for use. Prevention of iron deficiency anemia in 
baby pigs.
    (3) Limitations. Treat each pig within 24 hours of farrowing. 
Administer 1.8 milliliters orally by automatic dose dispenser.

[45 FR 75199, Nov. 14, 1980]



Sec.  520.1192  Ivermectin paste.

    (a) Specifications. Each milligram of paste contains 0.0187 
milligram (1.87 percent) or 0.00153 milligram (0.153 percent) of 
ivermectin.
    (b) Sponsors. See sponsor numbers in Sec.  510.600(c) of this 
chapter, as follows:
    (1) No. 050604 for use of a 1.87 percent paste as in paragraph 
(d)(1) of this section and a 0.153 percent paste as in paragraph (d)(2) 
of this section.
    (2) Nos. 051311 and 059130 for use of a 1.87 percent paste as in 
paragraph (d)(1) of this section.
    (c) Related tolerances. See Sec.  556.344 of this chapter.
    (d) Conditions of use--(1) Horses--(i) Amount. 200 micrograms per 
kilogram (91 micrograms per pound) of body weight.
    (ii) Indications for use. It is used in horses for the treatment and 
control of large strongyles (adult) (Strongylus equinus), (adult and 
arterial larval stages) (Strongylus vulgaris), (adult and migrating 
tissue stages) (Strongylus edentatus), (adult) (Triodontophorus spp.); 
small strongyles, including those resistant to some benzimidazole class 
compounds (adult and fourth stage larvae) (Cyathostomum spp., 
Cylicocyclus spp., Cylicodontophorus spp., Cylicostephanus spp.); 
pinworms (adult and fourth stage larvae) (Oxyuris equi); ascarids 
(third- and fourth-stage larvae and adults) (Parascaris equorum); 
hairworms (adult) (Trichostrongylus axei); large mouth stomach worms 
(adult) (Habronema muscae); stomach bots (oral and gastric stages) 
(Gastrophilus 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; and dermatitis caused by neck threadworm 
microfilariae (Onchocerca spp.).
    (iii) Limitations. For oral use only. Do not use in horses intended 
for food purposes. Consult your veterinarian for assistance in the 
diagnosis, treatment, and control of parasitism.
    (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

[[Page 146]]

age. Consult your veterinarian for assistance in the diagnosis, 
treatment, and control of parasitism.

[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]



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. 050604 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) No. 051311 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.
    (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]



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. 050604, 051259, 058829, and 059130 for use of product 
described in paragraph (a)(1) of this section as in paragraph (e)(1) of 
this section.
    (2) Nos. 050604 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 the treatment and control of 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.).

[[Page 147]]

    (iii) Limitations. Do not use in horses intended for food purposes. 
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]



Sec.  520.1196  Ivermectin and pyrantel pamoate chewable tablets.

    (a) Specifications. Each chewable tablet contains either 68 
micrograms ([mu]g) of ivermectin and 57 milligrams (mg) of pyrantel (as 
pamoate salt), or 136 [mu]g and 114 mg, or 272 [mu]g and 227 mg, 
respectively.
    (b) Sponsors. See Nos. 050604 and 051311 in Sec.  510.600(c) of this 
chapter.
    (c) Conditions of use--(1) Dogs--(i) Amount. A minimum of 6 [mu]g of 
ivermectin and 5 mg of pyrantel (as pamoate salt) per kilogram (2.72 
[mu]g and 2.27 mg per pound) of body weight.
    (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 adult 
ascarids Toxocara canis and Toxascaris leonina, and adult hookworms 
Ancylostoma caninum, A. braziliense, and Uncinaria stenocephala.
    (iii) Limitations. Use monthly. Recommended for dogs 6 weeks of age 
and older. 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]



Sec.  520.1197  Ivermectin sustained-release bolus.

    (a) Specifications. Each sustained-release bolus contains 1.72 grams 
of ivermectin.
    (b) Sponsor. See No. 050604 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]

[[Page 148]]



Sec.  520.1204  Kanamycin sulfate, aminopentamide hydrogen sulfate, pectin, bismuth subcarbonate, activated attapulgite suspension.

    (a) Specifications. Each five milliliters of suspension of the drug 
contains: 100 milligrams of kanamycin as the sulfate, 0.033 milligram of 
aminopentamide hydrogen sulfate, 25 milligrams of pectin, 250 milligrams 
of bismuth subcarbonate, and 500 milligrams of activated attapulgite.
    (b) Sponsor. See No. 000856 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use. (1) It is administered orally to dogs for the 
symptomatic relief of acute bacterial diarrhea caused by kanamycin-
susceptible organisms.
    (2) The drug is recommended for use at the rate of one teaspoonful 
(5 milliliters) of suspension per 20 pounds of body weight every 8 
hours. Animals weighing under 10 pounds should be given one-half the 
above amount every 8 hours. The initial dose should be twice the amount 
of a single dose. Maximum dosage should not exceed three times the 
recommended dose.
    (3) For use only 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]



Sec.  520.1205  Kanamycin sulfate, pectin, bismuth subcarbonate, activated attapulgite tablets.

    (a) Specifications. Each tablet contains 100 milligrams of kanamycin 
(as the sulfate), 25 milligrams of pectin, 250 milligrams of bismuth 
subcarbonate, and 500 milligrams of activated attapulgite.
    (b) Sponsor. See No. 000856 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use--(1) Amount. One tablet per 44 kilograms (20 
pounds) of body weight every 8 hours. Maximum dose 3 tablets every 8 
hours. For animals under 22 kilograms (10 pounds) \1/2\ tablet every 8 
hours. The 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 associated diarrhea in dogs.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[56 FR 8710, Mar. 1, 1991]



Sec.  520.1242  Levamisole hydrochloride oral dosage forms.



Sec.  520.1242a  Levamisole hydrochloride drench and drinking water.

    (a) Specifications. Each package contains either 9.075, 11.7, 18.15, 
46.8, or 544.5 grams of levamisole hydrochloride.
    (b) Sponsors. Approval for sponsors in 21 CFR 510.600(c) for use as 
in paragraph (d) of this section as follows:
    (1) See No. 053501 for use of 46.8 gram package as in paragraph 
(d)(1) of this section, for 11.7 and 46.8 gram packages as in paragraph 
(d)(2) of this section, and for 9.075 and 18.15 gram packages as in 
paragraph (d)(3) of this section.
    (2) See 000061 for use of 46.8 and 544.5 gram packages as in 
paragraph (d)(1) of this section, for 11.7, 46.8, and 544.5 gram 
packages as in paragraph (d)(2) of this section, and for 18.15 gram 
package as in paragraph (d)(3) of this section.
    (3) See 057561 for use of 46.8 and 544.5 gram packages as in 
paragraphs (d)(1) and (d)(2) of this section.
    (4) See No. 059130 for use of 18.15-gram packages as in paragraph 
(d)(3) of this section.
    (c) Related tolerances. See Sec.  556.350 of this chapter.
    (d) Conditions of use. It is used as an anthelmintic at 0.365 gram 
per 100 pounds of body weight as follows:
    (1) Cattle--(i)  Amount. As a single oral dose drench using 46.8 or 
544.5 gram packet.
    (ii) Indications for use. Anthelmintic effective against the 
following nematode infections: Stomach worms (Haemonchus, 
Trichostrongylus, Ostertagia), intestinal worms (Trichostrongylus, 
Cooperia, Nematodirus, Bunostomum, Oesophagotomum), and lungworms 
(Dictyocaulus).
    (iii) Limitations. Conditions of constant helminth exposure may 
require retreatment within 2 to 4 weeks after the first treatment. Do 
not slaughter for food within 48 hours of treatment.

[[Page 149]]

Not for use in dairy animals of breeding age. Consult your veterinarian 
before using in severely debilitated animals. Consult your veterinarian 
for assistance in the diagnosis, treatment, and control of parasitism. 
Prepare solutions for use as follows:
    (a) Dissolve contents of 46.8 gram package in water to provide 1 
quart (32 fluid ounces) of drench solution and administer as a drench at 
1/4 ounce per 100 pounds of body weight as a single oral dose.
    (b) Dissolve contents of 46.8 gram package in water to provide 8.75 
fluid ounces of concentrate solution and administer as a drench at 2 
milliliters per 100 pounds of body weight as a single oral dose by 
syringe.
    (c) Dissolve contents of 544.5 gram package in 3 liters of water and 
administer as a drench at 2 milliliters per 100 pounds of body weight as 
a single oral dose.
    (2) Sheep--(i)  Amount. As a single oral dose drench using 11.7, 
46.8, or 544.5 gram packet.
    (a) 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).
    (b) Limitations. Dissolve in 1 gallon (128 fluid ounces) of water 
and administer as a single drench at 1 ounce (0.365 gram) per 100 pounds 
of body weight; 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 veterinarian 
before using in severely debilitated animals.
    (ii) Amount. 11.7 grams per packet.
    (a) Indications for use. See paragraph (f)(2)(i)(a) of this section.
    (b) Limitations. Dissolve in 1 quart (32 fluid ounces) of water and 
administer as a single drench at 1 ounce (0.365 gram) per 100 pounds of 
body weight or dissolve 1 packet in 10.9 fluid ounces of water and 
administer as a single drench at 1 cubic centimeter (0.036 gram) per 10 
pounds of body weight; 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 
veterinarian before using in severely debilitated animals.
    (iii) Limitations. Conditions of constant helminth exposure may 
require retreatment within 2 to 4 weeks after the first treatment. Do 
not slaughter for food within 72 hours of treatment. Consult your 
veterinarian before using in severely debilitated animals. Consult your 
veterinarian for assistance in the diagnosis, treatment, and control of 
parasitism. Prepare solutions for use as follows:
    (a) Dissolve contents of 11.7 gram package in 1 quart (32 ounces) of 
water and administer as a drench at 1 ounce per 100 pounds of body 
weight, or dissolve in 10.9 fluid ounces of water and administer as a 
drench at 1 milliliter per 10 pounds of body weight as a single oral 
dose.
    (b) Dissolve contents of 46.8 gram package in 128 fluid ounces (1 
gallon) of water and administer as a drench at 1 ounce per 100 pounds of 
body weight as a single oral dose.
    (c) Dissolve contents of 544.5 gram package in 3 liters of water and 
administer as a drench at 2 milliliters per 100 pounds of body weight as 
a single oral dose.
    (3) Swine--(i) Amount. 9.075 or 18.15 grams per bottle.
    (ii) Indications for use. Anthelmintic 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. Dissolve in water to provide 9.075 grams per 250 
milliliters or 18.15 grams per 500 milliliters. Add 10 milliliters (2 
teaspoons) of this concentrate solution to each gallon of drinking 
water. Allow 1 gallon of medicated drinking water for each 100 pounds of 
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 exposure to worms 
may require retreatment within 4 to 5 weeks after the first treatment.

[[Page 150]]

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.

[40 FR 13838, Mar. 27, 1975, as amended at 43 FR 11176, Mar. 17, 1978; 
44 FR 59508, Oct. 16, 1979; 44 FR 72586, Dec. 14, 1979; 46 FR 25085, May 
5, 1981; 52 FR 20598, June 2, 1987; 54 FR 18280, Apr. 28, 1989; 62 FR 
61625, Nov. 19, 1997; 63 FR 59713, Nov. 5, 1998; 67 FR 63055, Oct. 10, 
2002; 68 FR 4916, Jan. 31, 2003]



Sec.  520.1242b  Levamisole hydrochloride tablet or oblet (bolus).

    (a) Chemical name. (-)-2,3,5,6-Tetrahydro-6-phenylimidazo [2,1-b] 
thiazole monohydrochloride.
    (b) Specifications. Assay of not less than 98 percent by nonaqueous 
titration with 0.1 N potassium isopropoxide; 1 isomer minimum 95 percent 
pure by optical rotation.
    (c) Sponsor. See Nos. 000061 and 053501 in Sec.  510.600(c) of this 
chapter.
    (d) Required labeling. Consult your veterinarian for assistance in 
the diagnosis, treatment, and control of parasitism.
    (e) Related tolerances. See Sec.  556.350 of this chapter.
    (f) Conditions of use. (1) It is used in an oblet for cattle as 
follows:
    (i) Amount. 2.19 grams per oblet.
    (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. Administer as a single dose as follows: 250 to 
450 pounds, \1/2\ oblet; 450 to 750 pounds, 1 oblet; and 750 to 1,050 
pounds, 1\1/2\ oblets; 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) It is used in a tablet for sheep as follows:
    (i) Amount. 0.184 gram per tablet.
    (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. Administer one tablet for each 50 pounds of body 
weight; 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.

[40 FR 13838, Mar. 27, 1975, as amended at 44 FR 59507, Oct. 16, 1979; 
62 FR 61625, Nov. 19, 1997; 67 FR 63055, Oct. 10, 2002]



Sec.  520.1242c  Levamisole hydrochloride and piperazine dihydrochloride.

    (a) Specifications. (1) The drug is an aqueous solution which 
contains in each fluid ounce 0.36 gram of levamisole hydrochloride and 
piperazine dihydrochloride equivalent to 3.98 grams of piperazine base.
    (2) The drug is a soluble powder which when reconstituted 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. 053501 in Sec.  510.600(c) of this chapter.
    (c) [Reserved]
    (d) Conditions of use. It is used as a drench for horses as follows:
    (1) Indications for use. An anthelmintic effective against 
infections of large strongyles (Strongylus vulgaris, S. edentatus), 
small strongyles (Cylicocercus spp., Cylicocylclus spp., 
Cylicodontophorus spp., Cylicostephanus spp., Cylicotetrapedon spp.), 
ascarids (Parascaris equorum), and pinworms (Oxyuris equii).
    (2) Limitations. 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

[[Page 151]]

6- to 8-week intervals. Do not treat animals intended for food. Federal 
law restricts this drug to use by or on the order of a licensed 
veterinarian.

[40 FR 32831, Aug. 5, 1975, as amended at 41 FR 48731, Nov. 5, 1976; 43 
FR 11176 Mar. 17, 1978; 67 FR 63055, Oct. 10, 2002]



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 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. 053501 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]



Sec.  520.1242f  Levamisole hydrochloride gel.

    (a) Specifications. The drug is a gel containing 11.5 percent 
levamisole hydrochloride.
    (b) Sponsor. See No. 053501 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

[[Page 152]]

(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 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]



Sec.  520.1242g  Levamisole resinate and famphur paste.

    (a) Chemical name of famphur. O, O-Dimethyl O-[p-(dimethylsulfamoyl) 
phenyl] phosphorothioate.
    (b) Specifications. The drug is a paste containing 11.6 percent 
levamisole resinate (50 percent potency) and 23.6 percent famphur.
    (c) Sponsor. See 000061 in Sec.  510.600(c) of this chapter.
    (d) 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.
    (e) Related tolerances. See Sec.  556.350 of this chapter for 
levamisole and Sec.  556.273 of this chapter for famphur.
    (f) 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]



Sec.  520.1263  Lincomycin hydrochloride monohydrate oral dosage forms.



Sec.  520.1263a  Lincomycin hydrochloride monohydrate tablets and sirup.

    (a) Specifications. The sirup contains lincomycin hydrochloride 
equivalent to either 25 milligrams or 50 milligrams of lincomycin.
    (b) Sponsor. See No. 000009 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use. (1) The drug is indicated in infections 
caused by gram-positive organisms which are sensitive to its action, 
particularly streptococci and staphylococci.
    (2) It is administered orally to dogs and cats at a dosage level of 
10 mgs per pound of body weight every 12 hours, or 7 mgs per pound of 
body weight every 8 hours. Treatment may be continued for

[[Page 153]]

periods as long as 12 days if clinical judgment indicates.
    (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 44 FR 7130, Feb. 6, 1979; 64 
FR 403, Jan. 5, 1999]



Sec.  520.1263b  Lincomycin hydrochloride monohydrate and spectinomycin sulfate tetrahydrate soluble powder.

    (a) Specifications. The spectinomycin sulfate tetrahydrate used in 
manufacturing the drug is the antibiotic substance produced by the 
growth of Streptomyces spectabilis or the same antibiotic substance 
produced by any other means. The quantity of total antibiotic activity 
cited in this section refers to the equivalent weight of the base 
activity of the drugs. Lincomycin hydrochloride monohydrate and 
spectinomycin sulfate tetrahydrate are present in the drug in the ratio 
of 1 to 2 on the basis of equivalency of lincomycin base to equivalency 
of spectinomycin base.
    (b) Sponsor. See No. 000009 in Sec.  510.600(c) of this chapter.
    (c) Related tolerances. See Sec. Sec.  556.600 and 556.360 of this 
chapter.
    (d) Conditions of use. (1) It is administered in the drinking water 
of chickens up to 7 days of age as an aid in the control of 
airsacculitis caused by either Mycoplasma synoviae or Mycoplasma 
gallisepticum susceptible to lincomycin-spectinomycin and complicated 
chronic respiratory disease (air sac infection) caused by Escherichia 
coli and M. gallisepticum susceptible to lincomycin-spectinomycin.
    (2) For aid in the control of these conditions it is administered in 
the drinking water at a level of 2 grams of antibiotic activity per 
gallon of water as the sole source of water for the first 5 to 7 days of 
life.

[40 FR 13838, Mar. 27, 1975, as amended at 41 FR 1891, Jan. 13, 1976; 64 
FR 403, Jan. 5, 1999]



Sec.  520.1263c  Lincomycin hydrochloride soluble powder.

    (a) Specifications. Each gram of soluble powder contains lincomycin 
hydrochloride equivalent to 0.4 grams of lincomycin.
    (b) Sponsors. See Nos. 000009, 046573, 051259, and 059130 in Sec.  
510.600(c) of this chapter for use as in paragraph (d) 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. 051259: Do not slaughter swine for 6 days 
following last treatment.
    (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.

[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]



Sec.  520.1284  Sodium liothyronine tablets.

    (a) Specifications. Sodium liothyronine tablets consist of tablets 
intended for oral administration which contain liothyronine at 60 or 120 
micrograms per tablet, as the sodium salt.
    (b) Sponsor. See No. 000069 in Sec.  510.600(c) of this chapter.

[[Page 154]]

    (c) Conditions of use. (1) It is indicated in cases of 
hypothyroidism in dogs.
    (2) It is administered orally to dogs at levels up to 12.8 
micrograms per kilogram 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[mu]g per 
kilogram of body weight) should be considered for initiating therapy and 
then titrated downward for optimum maintenance effect. Twice daily 
administration is recommended.
    (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 56 FR 50653, Oct. 8, 1991; 60 
FR 55659, Nov. 2, 1995]



Sec.  520.1288  Lufenuron tablets.

    (a) Specifications--(1) Dogs. Each tablet contains either 45, 90, 
204.9, or 409.8 milligrams (mg) of lufenuron.
    (2) Cats. Each tablet contains either 90, 135, 204.9 or 270 mg of 
lufenuron.
    (b) Sponsor. See No. 058198 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use in dogs--(1) Amount. Minimum of 10 mg of 
lufenuron per kilogram (4.5 mg per pound (lb)) of body weight.
    (2) Indications for use. For use in dogs and puppies, 6 weeks of age 
and older, for the prevention and control of flea populations. Lufenuron 
controls flea populations by preventing the development of flea eggs and 
does not kill adult fleas. Concurrent use of insecticides may be 
necessary for adequate control of adult fleas.
    (3) Limitations. Administer tablet(s) after or in conjunction with a 
full meal to ensure adequate absorption. Administer tablet(s) once a 
month. All dogs and cats in a household should be treated to achieve 
maximum efficacy.
    (d) Conditions of use in cats--(1) Amount. Minimum of 30 mg of 
lufenuron per kilogram (13.6 mg/lb) of body weight.
    (2) Indications for use. For use in cats and kittens, 6 weeks of age 
and older, for the control of flea populations. Lufenuron controls flea 
populations by preventing the development of flea eggs and does not kill 
adult fleas. Concurrent use of insecticides may be necessary for 
adequate control of adult fleas.
    (3) Limitations. Administer tablet(s) after or in conjunction with a 
full meal to ensure adequate absorption. Administer tablet(s) once a 
month. All dogs and cats in a household should be treated to achieve 
maximum efficacy.

[63 FR 52968, Oct. 2, 1998]



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 tablets.

    (a) Specifications. Each tablet contains 25, 50, 100, or 200 
milligrams (mg) marbofloxacin.
    (b) Sponsor. See No. 000069 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

[[Page 155]]

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]



Sec.  520.1320  Mebendazole oral.

    (a) Chemical name. Methyl 5-benzoyl-benzimindazole-2-carbamate.
    (b) Specifications. As oral powder: Each gram contains either 40 or 
166.7 milligrams of mebendazole. As oral paste: Each gram contains 200 
milligrams of mebendazole. As oral suspension: Each milliliter contains 
33.3 milligrams of mebendazole.
    (c) Sponsor. See No. 000061 in Sec.  510.600(c) of this chapter.
    (d) 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.
    (ii) Indications for use. It is used in horses 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--(a) Oral powder. The drug is given by sprinkling 
directly on the grain portion of the ration or dissolving in 2 to 4 
pints of water and administering by stomach tube. The drug is compatible 
with carbon disulfide, which can be used concurrently for both control 
(Gastrophilus spp.). Routine cautions regarding the use of carbon 
disulfide must be observed. Do not administer to horses intended for use 
as food. Federal law restricts this drug to use by or on the order of a 
licensed veterinarian.
    (b) Oral paste. The drug is given by dosing gun (syringe), inserting 
the tip of the gun at the interdental space in the horse's mouth and 
depositing the paste on the animal's tongue. The hand is placed under 
the animal's jaw, and the head is raised to assure that the paste is 
deposited on the roof of the mouth. Not for use in horses intended for 
food. Consult your veterinarian for assistance in the diagnosis, 
treatment, and control of parasitism.
    (c) Oral suspension. The drug is administered by stomach tube. Not 
for horses intended for food use. Federal law restricts this drug to use 
by or on the order of a licensed veterinarian.
    (2) Dogs--(i) Amount. One hundred milligrams of mebendazole per 10 
pounds of body weight, once daily for 3 days, as an oral powder.
    (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. Administer as an oral powder by mixing with a 
small quantity of food, preferably before the regular meal. Federal law 
restricts this drug to use by or on the order of a licensed 
veterinarian.

[42 FR 61255, Dec. 2, 1977, as amended at 43 FR 35686, Aug. 11, 1978; 45 
FR 3574, Jan. 18, 1980; 46 FR 47218, Sept. 25, 1981; 46 FR 53658, Oct. 
30, 1981; 62 FR 61625, Nov. 19, 1997]



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. 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. Administer orally as an individual dose by stomach 
tube or throughly mixed in the ground grain portion of the ration to be 
consumed in one feeding. Discard treated feed not consumed. 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. Trichlorofon is a cholinesterase inhibitor. Do not 
administer simultaneously or within a few

[[Page 156]]

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 horses 
intended for food use. 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]



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--(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]



Sec.  520.1330  Meclofenamic acid granules.

    (a) Chemical name. N-(2,6-Dichlorom-tolyl) anthranilic acid.
    (b) Specifications. The drug is in granular form containing 5 
percent meclofenamic acid.
    (c) Sponsor. See No. 000856 in Sec.  510.600(c) of this chapter.
    (d) Conditions of use. (1) The drug is used in horses for the 
treatment of acute or chronic inflammatory diseases involving the 
musculoskeletal system.
    (2) It is administered orally at a dosage of 1 milligram per pound 
of body weight (1 gram per 1,000 pounds) once daily for 5 to 7 days by 
addition to the daily grain ration.
    (3) Treatment beyond the initial 5- to 7-day period may be 
indicated. A maintenance dosage level should be individualized for each 
animal.
    (4) This drug should not be administered to horses with active 
gastrointestinal, hepatic, or renal disease.
    (5) Not for use in horses intended for food.
    (6) Federal law restricts this drug to use by or on the order of a 
licensed veterinarian.

[41 FR 5632, Feb. 9, 1976, as amended at 53 FR 23390, June 22, 1988]



Sec.  520.1331  Meclofenamic acid tablets.

    (a) Specifications. Each tablet contains either 10 or 20 milligrams 
of meclofenamic acid.
    (b) Sponsor. See No. 000856 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. For oral use only. Should not be administered to 
animals with congestive heart failure or active gastrointestinal, 
hepatic, or renal disease. 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]



Sec.  520.1341  Megestrol acetate tablets.

    (a) Specifications. Each tablet contains 5 or 20 milligrams of 
megestrol acetate.
    (b) Sponsor. No. 000061 in Sec.  510.600(c) of this chapter.

[[Page 157]]

    (c) Conditions of use. (1) The drug is used in female dogs for the 
postponement of estrus and the alleviation of false pregnancy.
    (2) It is administered 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.
    (3) Full dosage regimen must be completed to produce the desired 
effect.
    (4) Examination of vaginal smears is recommended to confirm 
detection of proestrus.
    (5) Do not administer for more than two consecutive treatments.
    (6) Once therapy is started, the animal should be confined for 3 to 
8 days or until cessation of bleeding, since dogs in proestrus accept a 
male.
    (7) Do not use prior to or during first estrus cycle.
    (8) Do not use in pregnant animals.
    (9) Do not use in the presence of a disease of the reproductive 
system or with mammary tumors.
    (10) Should estrus occur within 30 days after cessation of 
treatment, mating should be prevented.
    (11) 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]



Sec.  520.1380  Methocarbamol tablets.

    (a) Chemical name. 3-(O-Methoxyphenoxy)-1,2-propanediol 1-carbamate.
    (b) Specifications. Each tablet contains 500 milligrams of 
methocarbamol.
    (c) Sponsor. See No. 000856 in Sec.  510.600(c) of this chapter.
    (d) Conditions of use. (1) The drug is administered to dogs and cats 
as an adjunct to therapy for acute inflammatory and traumatic conditions 
of the skeletal muscles in order to reduce muscular spasms.
    (2) Dosage is based upon severity of symptoms and response noted. 
The usual initial dose in 60 milligrams per pound of body weight in two 
or three equally divided doses followed by 30 to 60 milligrams per pound 
of body weight each following day, usually not to exceed 14 to 21 days.
    (3) For use only by or on the order of a licensed veterinarian.

[40 FR 13838, Mar. 27, 1975, as amended at 67 FR 67521, Nov. 6, 2002]



Sec.  520.1390  (S)-methoprene.

    (a) Specifications. Each capsule contains 154, 308, or 462 
milligrams (mg) of (S)-methoprene.
    (b) Sponsor. See No. 011536 in Sec.  510.600(c) of this chapter.
    (c) [Reserved]
    (d) Conditions of use--(1) Amount. Capsules are given orally, once 
per week at the recommended minimum dosage of 10 mg of (S)-methoprene 
per pound of body weight (22 mg/kilograms).
    (2) Indications for use. For oral use in dogs, 9 weeks of age and 
older and 4 pounds body weight or greater, for the prevention and 
control of flea populations. (S)-methoprene prevents and controls flea 
populations by preventing the development of flea eggs but does not kill 
adult fleas. Concurrent use of insecticides may be necessary for 
adequate control of adult fleas.

[65 FR 20730, Apr. 18, 2000]



Sec.  520.1408  Methylprednisolone tablets.

    (a) Specifications. Each table contains 1, 2, or 4 milligrams of 
methylprednisolone.
    (b) Sponsor. See No. 000009 in Sec.  510.600(c) of this chapter for 
use of 1- and 4-milligram tablets; see No. 000010 for use of 1- and 2-
milligram tablets.
    (c) NAS/NRC status. The conditions of use have been NAS/NRC reviewed 
and found effective. NADA's for approval of drugs for these conditions 
of use need not include effectiveness data specified by Sec.  514.111 of 
this chapter, but may require bioequivalency and safety information.
    (d) Special consideration. (1) Clinical and experimental data have 
demonstrated that corticosteroids administered orally or parenterally to 
animals

[[Page 158]]

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.
    (2) Systemic therapy with methylprednisolone is contraindicated in 
animals with arrested tuberculosis, peptic ulcer, acute psychoses, or 
cushingoid syndrome. The presence of active tuberculosis, diabetes, 
osteoporosis, chronic psychotic reactions, predisposition to 
thrombophlebitis, hypertension, congestive heart failure, or renal 
insufficiency necessitates carefully controlled use of corticosteroids. 
Some of these conditions occur only rarely in dogs and cats but should 
be kept in mind.
    (3) Anti-inflammatory action of corticosteroids may mask signs of 
infection.
    (e) Conditions of use--(1) Amount. Dogs and cats: 5 to 15 pounds, 2 
milligrams; 15 to 40 pounds, 2 to 4 milligrams; 40 to 80 pounds, 4 to 8 
milligrams.
    (2) Indications for use. For use in dogs and cats as an anti-
inflammatory agent.
    (3) Limitations. 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. Hazardous for human use. Federal 
law restricts this drug to use by or on the order of a licensed 
veterinarian.

[47 FR 52697, Nov. 23, 1982, as amended at 49 FR 20810, May 17, 1984; 50 
FR 32844, Aug. 15, 1985; 53 FR 40727, Oct. 18, 1988; 62 FR 35076, June 
30, 1997]



Sec.  520.1409  Methylprednisolone, aspirin tablets.

    (a) Specifications. Each tablet contains 0.5 milligram of 
methylprednisolone and 300 milligrams of aspirin.
    (b) Sponsor. See No. 000009 in Sec.  510.600(c) of this chapter.
    (c) NAS/NRC status. The conditions of use have been NAS/NRC reviewed 
and found effective. New animal drug applications for approval of drugs 
for these conditions of use need not include effectiveness data 
specified by Sec.  514.111 of this chapter, but may require 
bioequivalency and safety information.
    (d) Special considerations. (1) Clinical and experimental data have 
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.
    (2) Systemic therapy with methylprednisolone is contraindicated in 
animals with tuberculosis, chronic nephritis, peptic ulcer, or 
Cushingoid syndrome. The presence of diabetes mellitus, osteoporosis, 
predisposition to thrombophlebitis, hypertension, congestive heart 
failure, or renal insufficiency necessitates carefully controlled use of 
corticosteroids.
    (3) Anti-inflammatory action of corticosteroids may mask signs of 
infection.
    (e) Conditions of use--(1) Amount. Dogs 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.
    (2) Indications for use. As an anti-inflammatory and analgesic agent 
in dogs.
    (3) Limitations. 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. Do not 
administer to cats. Do not overdose. Federal law restricts this drug to 
use by or on the order of a licensed veterinarian.

[48 FR 21566, May 13, 1983]



Sec.  520.1422  Metoserpate hydrochloride.

    (a) Chemical name. Methyl-o-methyl-18-epireserpate hydrochloride.
    (b) Sponsor. See No. 000003 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.

[[Page 159]]

    (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 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.



Sec.  520.1430  Mibolerone.

    (a) Specifications. Each milliliter contains 100 micrograms of 
mibolerone.
    (b) Sponsor. See No. 000009 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use--(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.
    (2) Indications for use. For the prevention of estrus (heat) in 
adult female dogs not intended primarily for breeding purposes.
    (3) Limitations. 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. Mibolerone 
should not be used in bitches before the first estrous period. 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.

[43 FR 15625, Apr. 14, 1978]



Sec.  520.1445  Milbemycin oxime tablets.

    (a) Specifications--(1) Dogs. Each tablet contains 2.3, 5.75, 11.5, 
or 23.0 milligrams of milbemycin oxime.
    (2) Cats. Each tablet contains 5.75, 11.5, or 23.0 milligrams of 
milbemycin oxime.
    (b) Sponsor. See 058198 in Sec.  510.600(c) of this chapter.
    (c) [Reserved]
    (d) Conditions of use--(1) Dogs and puppies--(i) Amount. For 
hookworm, roundworm, and whipworm, use 0.23 milligram per pound of body 
weight (0.5 milligram per kilogram). For heartworm, use 0.05 milligram 
per pound of body weight (0.1 milligram per kilogram).
    (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 in puppies 4 weeks of 
age or greater and 2 pounds of body weight or greater.
    (iii) Limitations. Do not use in puppies less than 4 weeks of age 
and less than 2 pounds of body weight. Administer once a month. First 
dose given within 1 month after first exposure to mosquitoes and 
continue regular use until at least 1 month after end of mosquito 
season. Federal law restricts this drug to use by or on the order of a 
licensed veterinarian.
    (2) Cats and kittens--(i) Amount. 0.91 milligram per pound of body 
weight (2.0 milligrams per kilogram).
    (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. Do not use in kittens less than 6 weeks of age or 
1.5 pounds body weight. Administer once a month. Federal law restricts 
this drug to use

[[Page 160]]

by or on the order of a licensed veterinarian.

[55 FR 25301, June 21, 1990, as amended at 55 FR 49888, Dec. 3, 1990; 58 
FR 5608, Jan. 22, 1993; 60 FR 50097, Sept. 28, 1995; 61 FR 43654, Aug. 
26, 1996; 63 FR 29352, May 29, 1998; 63 FR 41189, Aug. 3, 1998]



Sec.  520.1446   Milbemcyin oxime/lufenuron tablets.

    (a) Specifications. Tablets containing: 2.3 milligrams milbemycin 
oxime/46 milligrams lufenuron, 5.75 milligrams/115 milligrams, 11.5 
milligrams/230 milligrams, and 23 milligrams/460 milligrams.
    (b) Sponsor. See No. 058198 in Sec.  510.600(c) of this chapter.
    (c) [Reserved]
    (d) Conditions of use--(1) Dogs--(i) Amount. 0.5 milligrams of 
milbemycin and 10 milligrams of lufenuron per kilogram of body weight.
    (ii) Indications for use. For use in dogs and puppies for the 
prevention of heartworm disease caused by Dirofilaria immitis, for 
prevention and control of flea populations, control of adult Ancylostoma 
caninum (hookworm), and removal and control of adult Toxocara canis, 
Toxascaris leonina (roundworm), and Trichuris vulpis (whipworm) 
infections. Lufenuron controls flea populations by preventing the 
development of flea eggs and does not kill adult fleas. Concurrent use 
of insecticides may be necessary for adequate control of adult fleas.
    (iii) Limitations. Administer tablets once a month, preferably on 
the same date each time. All dogs in a household should be treated to 
achieve maximum efficacy. Do not use in dogs less than 4 weeks of age 
and less than 2 pounds body weight. 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]



Sec.  520.1448  Monensin oral dosage forms.

    Monensin, as the base or the sodium salt, contains a minimum of 90 
percent monensin activity derived from monensin A and a minimum of 95 
percent derived from monensin A plus B. Using thin layer chromatography, 
the Rf value must be comparable to a reference standard (the 
Rf value is the distance the spots travel from the starting 
line divided by the distance the solvent front travels from the starting 
line). The loss on drying is not more than 10 percent when dried in 
vacuum at 60 [deg]C for 2 hours.

[55 FR 3586, Feb. 2, 1990]



Sec.  520.1448a  Monensin blocks.

    (a)(1) Specifications. Each pound of protein-mineral block contains 
400 milligrams of monensin (0.088 percent) as monensin sodium.
    (2) Sponsor. See 036904 in Sec.  510.600(c) of this chapter.
    (3) Related tolerances. See Sec.  556.420 of this chapter.
    (4) Conditions of use--(i) Amount. 80 to 200 milligrams of monensin 
(0.2 to 0.5 pound of block) per head per day.
    (ii) Indications for use. Increased rate of weight gain.
    (iii) Limitations. Block to be fed free choice to pasture cattle 
(slaughter, stocker, feeder, and dairy and beef replacement heifers). 
Provide at least 1 block per 5 head of cattle. Feed blocks continuously. 
Do not feed salt or minerals containing salt. Do not allow horses or 
other equines access to formulations containing monensin (ingestion of 
monensin by equines has been fatal). The effectiveness of this block in 
cull cows and bulls has not been established.
    (b) [Reserved]
    (c)(1) Specifications. Each pound of protein block contains 175 
milligrams of monensin (0.038 percent) as monensin sodium.
    (2) Sponsor. See 021676 in Sec.  510.600(c) of this chapter.
    (3) Related tolerances. See Sec.  556.420 of this chapter.
    (4) Conditions of use--(i) Amount. 40 to 200 milligrams of monensin 
(0.25 to 1.13 pounds or 4 to 18 ounces of block) per head per day.
    (ii) Indications for use. Increased rate of weight gain.
    (iii) Limitations. Blocks to be fed free choice to pasture cattle 
(slaughter, stocker, and feeder). Provide 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

[[Page 161]]

has been fatal. Do not allow horses or other equines access to 
formulations containing monensin (ingestion of monensin by equines has 
been fatal). Block's effectiveness in cull cows and bulls has not been 
established.
    (d)(1) Specifications. Each pound of block contains 400 milligrams 
of monensin (0.088 percent) as monensin sodium.
    (2) Sponsor. See 051267 in Sec.  510.600(c) of this chapter.
    (3) Related tolerances. See Sec.  556.420 of this chapter.
    (4) Conditions of use--(i) Amount. 50 to 200 milligrams of monensin 
(2 to 8 ounces of block) per head per day.
    (ii) Indications for use. Pasture cattle: Increased rate of weight 
gain.
    (iii) Limitations. Blocks to be fed free choice to pasture cattle 
(slaughter, stocker, feeder, and dairy and beef replacement heifers). 
Provide at least one block per five head of cattle. Feed blocks 
continously. Do not feed salt or mineral supplements in addition to the 
blocks. Ingestion by cattle of monensin at levels of 600 milligrams per 
head per day and higher has been fatal. Do not allow horses or other 
equines access to formulations containing monensin (ingestion of 
monensin by equines has been fatal). The effectiveness of this block in 
cull cows and bulls has not been established.

[46 FR 19466, Mar. 31, 1981]

    Editorial Note: For Federal Register citations affecting Sec.  
520.1448a, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and on GPO Access.



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. 000069 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 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]



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. 000069 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

[[Page 162]]

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]



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 000069 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]



Sec.  520.1451  Moxidectin.

    (a) Specifications. Each tablet contains 30, 68, or 136 micrograms 
of moxidectin.
    (b) Sponsor. See No. 000856 in Sec.  510.600(c) of this chapter.
    (c) [Reserved]
    (d) 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. Use once-a-month in dogs at 8 weeks of age or 
older. Federal law restricts this drug to use by or on the order of a 
licensed veterinarian.

[62 FR 37713, July 15, 1997]



Sec.  520.1452  Moxidectin gel.

    (a) Specifications. The gel contains 2 percent moxidectin (20 
milligrams per milliliter).
    (b) Sponsor. See No. 000856 in Sec.  510.600(c) of this chapter.
    (c) [Reserved]
    (d) Conditions of use--(1) Amount. 0.4 milligram moxidectin per 
kilogram (2.2 pounds) of body weight.
    (2) Indications for use. Horses and ponies for treatment and control 
of large strongyles (Strongylus vulgaris (adults and L4/L5 arterial 
stages), S. edentatus (adult and tissue stages), Triodontophorus 
brevicauda (adults), T. serratus (adults)); small strongyles 
(Cyathostomum spp. (adults), Cylicocyclus spp. (adults), Cylicostephanus 
spp. (adults), Gyalocephalus capitatus (adults), 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.

[[Page 163]]

    (3) Limitations. Not for use in horses and ponies intended for food.

[62 FR 42902, Aug. 11, 1997, as amended at 64 FR 66105, Nov. 24, 1999]



Sec.  520.1468  Naproxen granules.

    (a) Specifications. Naproxen granules contain 50 percent naproxen.
    (b) Sponsor. No. 000856 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use--(1) Horses. The drug is used 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.
    (2)(i) For oral maintenance therapy following initial intravenous 
dosage, administer 10 milligrams naproxen per kilogram of animal body 
weight twice daily as top dressing in the animal's feed for up to 14 
consecutive days. The initial intravenous dosage is 5 milligrams per 
kilogram of body weight.
    (ii) For oral dosage only, administer 10 milligrams naproxen per 
kilogram of animal body weight twice daily as a top dressing in the 
animal's feed for up to 14 consecutive days.
    (3) Not for use in horses intended for food.
    (4) Federal law restricts this drug to use by or on the order of a 
licensed veterinarian.

[41 FR 14188, Apr. 2, 1976, as amended at 51 FR 24525, July 7, 1986; 61 
FR 5506, Feb. 13, 1996]



Sec.  520.1484  Neomycin sulfate soluble powder.

    (a) Specifications. Each ounce of powder contains 20.3 grams of 
neomycin sulfate (equivalent to 14.2 grams of neomycin base).
    (b) Sponsors. See sponsors in Sec.  510.600(c) of this chapter for 
use as in paragraph (d) of this section.
    (1) Nos. 000069 and 051259 for use as in paragraph (d)(1) of this 
section.
    (2) Nos. 000009, 046573, and 061623 for use as in paragraphs (d)(1) 
and (d)(2) of this section.
    (c) Related tolerances. See Sec.  556.430 of this chapter.
    (d) Conditions of use--(1) Cattle (excluding veal calves), swine, 
sheep, and goats.
    (i) Amount. 10 milligrams of neomycin sulfate per pound of body 
weight per day (22 milligrams per kilogram) 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 in cattle (excluding veal calves), 
swine, sheep, and goats.
    (iii) Limitations. Add to drinking water or milk; not for use in 
liquid supplements. Prepare a fresh solution daily. If symptoms persist 
after using this preparation for 2 or 3 days, consult a veterinarian. 
Treatment should continue 24 to 48 hours beyond remission of disease 
symptoms, but not to exceed a total of 14 consecutive days. Discontinue 
treatment prior to slaughter as follows: Cattle (not for use in veal 
calves), 1 day; sheep, 2 days; swine and goats, 3 days.
    (2) Turkeys--(i) Amount. 10 milligrams of neomycin sulfate per pound 
of body weight per day (22 milligrams per kilogram) for 5 days.
    (ii) Indications for use. For the control of mortality associated 
with E. coli organisms susceptible to neomycin sulfate in growing 
turkeys.
    (iii) Limitations. Add to drinking water; not for use in liquid 
supplements. Prepare a fresh solution daily. If symptoms persist after 
using this preparation for 2 or 3 days, consult a veterinarian. 
Treatment should continue 24 to 48 hours beyond remission of disease 
symptoms, but not to exceed a total of 5 consecutive days.

[64 FR 31497, June 11, 1999, as amended at 66 FR 14073, Mar. 9, 2001; 67 
FR 72366, Dec. 5, 2002; 67 FR 78971, Dec. 27, 2002; 68 FR 4914, Jan. 31, 
2003]



Sec.  520.1485  Neomycin sulfate oral solution.

    (a) Specifications. Each milliliter contains 200 milligrams of 
neomycin sulfate (equivalent to 140 milligrams of neomycin base).
    (b) Sponsors. See Nos. 000009, 051259, and 059130 in Sec.  
510.600(c) of this chapter.
    (c) Related tolerances. See Sec.  556.430 of this chapter.
    (d) Conditions of use--(1) Amount. 10 milligrams of neomycin sulfate 
per

[[Page 164]]

pound of body weight per day in divided doses for a maximum of 14 days.
    (2) Indications for use. For the treatment and control of 
colibacillosis (bacterial enteritis) caused by Escherichia coli 
susceptible to neomycin in cattle (excluding veal calves), swine, sheep, 
and goats.
    (3) Limitations. Administer undiluted or in drinking water. Prepare 
a fresh solution daily. If symptoms persist after using this preparation 
for 2 or 3 days, consult a veterinarian. Treatment should continue 24 to 
48 hours beyond remission of disease symptoms, but not to exceed a total 
of 14 consecutive days. Discontinue treatment prior to slaughter as 
follows: 1 day for cattle, 2 days for sheep, and 3 days for swine and 
goats.

[58 FR 38972, July 21, 1993, as amended at 60 FR 3079, Jan. 13, 1995; 61 
FR 31398, June 20, 1996; 62 FR 60657, Nov. 12, 1997; 63 FR 45944, Aug. 
28, 1998; 65 FR 45877, July 26, 2000; 65 FR 53581, Sept. 5, 2000]



Sec.  520.1510  Nitenpyram.

    (a) Specifications. Each tablet contains 11.4 or 57 milligrams of 
nitenpyram.
    (b) Sponsor. See No. 058198 in Sec.  510.600(c) of this chapter.
    (c) [Reserved]
    (d) Conditions of use--Dogs and cats--(1) Amount. One tablet given 
orally, as needed.
    (2) Indications for use. For the treatment of flea infestations on 
dogs, puppies, cats, and kittens 4 weeks of age and older and 2 pounds 
of body weight or greater.

[65 FR 70662, Nov. 27, 2000]



Sec.  520.1615  Omeprazole.

    (a) Specifications. Each gram of oral paste contains 0.37 gram of 
omeprazole.
    (b) Sponsor. See No. 050604 in Sec.  510.600(c) of this chapter.
    (c) [Reserved]
    (d) Conditions of use--(1) Amount. For treatment of gastric ulcers, 
1.8 milligrams of omeprazole per pound of body weight (4 milligrams per 
kilogram) once daily for 4 weeks. For prevention of recurrence of 
gastric ulcers, 0.9 milligram of omeprazole per pound of body weight (2 
milligrams per kilogram) once daily for at least an additional 4 weeks.
    (2) Indications for use. For treatment and prevention of recurrence 
of gastric ulcers in horses and foals 4 weeks of age and older.
    (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.

[64 FR 18573, Apr. 15, 1999]



Sec.  520.1616  Orbifloxacin tablets.

    (a) Specifications. Each tablet contains 5.7, 22.7, or 68 milligrams 
of orbifloxacin.
    (b) Sponsor. See No. 000061 in Sec.  510.600(c) of this chapter.
    (c) [Reserved]
    (d) Conditions of use--(1) Dogs and cats--(i) Amount. 2.5 to 7.5 
milligrams per kilogram body weight.
    (ii) Indications for use. For management of diseases associated with 
bacteria susceptible to orbifloxacin.
    (iii) Limitations. Administer orally once daily for 2 to 3 days 
beyond cessation of clinical signs for up to a maximum of 30 days. If no 
improvement is seen within 5 days, diagnosis should be reevaluated and a 
different course of therapy considered. Orbifloxacin is contraindicated 
in immature dogs and cats during the rapid growth phase. Orbifloxacin 
and other quinolones have been shown to cause arthropathy in immature 
animals of most species. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.
    (2) [Reserved]

[62 FR 29012, May 29, 1997, as amended at 62 FR 61627, Nov. 19, 1997]



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. 000856 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

[[Page 165]]

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 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]



Sec.  520.1629  Oxfendazole paste.

    (a)(1) Specifications. Each gram of paste contains 0.375 gram 
oxfendazole (37.5 percent).
    (2) Sponsor. See No. 000856 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. 000856 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]



Sec.  520.1630  Oxfendazole suspension.

    (a) Specifications. Each milliliter contains 90.6 or 225.0 
milligrams oxfendazole (9.06 or 22.5 percent).
    (b) Sponsor. See 000856 in Sec.  510.600(c) of this chapter.
    (c) Related tolerances. See Sec.  556.495 of this chapter.
    (d) Conditions of use--(1) Horses (9.06 percent suspension only).
    (i) Amount. 10 milligrams per kilogram (2.2 pounds) of body weight.
    (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.

[[Page 166]]

    (iii) Limitations. Administer 9.06 percent suspension by stomach 
tube or dose syringe. 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. Do not use in horses intended for food. If 
administered by stomach tube: Federal law restricts this drug to use by 
or on the order of a licensed veterinarian. If administered by dose 
syringe only: Consult your veterinarian for assistance in the diagnosis, 
treatment, and control of parasitism.
    (2) Cattle. (9.06 or 22.5 percent suspension). (i) Amount. 4.5 
milligrams per kilogram of body weight (2.05 milligrams per pound).
    (ii) Indications for use. For the removal and control of: 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. Administer 9.06 percent 
suspension orally only with a dose syringe, and 22.5 percent suspension 
either orally with a dose syringe or intraruminally with a rumen 
injector. Treatment may be repeated in 4 to 6 weeks. Cattle must not be 
slaughtered until 7 days after treatment. Do not use in lactating dairy 
cattle. For use of 9.06 percent suspension orally: Consult a 
veterinarian for assistance in the diagnosis, treatment, and control of 
parasitism. For use of 22.5 percent suspension orally or intraruminally: 
Federal law restricts this drug to use by or on the order of a licensed 
veterinarian.

[55 FR 46943, Nov. 8, 1990, as amended at 56 FR 8710, Mar. 1, 1991; 61 
FR 5506, Feb. 13, 1996]



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 000856 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]



Sec.  520.1638  Oxibendazole paste.

    (a) Specifications. The paste contains 22.7 percent oxibendazole.
    (b) Sponsor. See 000069 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use in horses--(1) Amount. For uses other than for 
threadworms (Strongyloides westeri), 10 milligrams of oxibendazole per 
kilogram of body weight; for threadworms (Strongyloides westeri), 15 
milligrams per kilogram.
    (2) Indications for use. For removal and control of large strongyles 
(Strongylus edentatus, S. equinus, S.

[[Page 167]]

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. Administer orally by syringe. Horses maintained on 
premises where reinfection is likely to occur should be re-treated in 6 
to 8 weeks. Not for use in horses intended for food. Consult a 
veterinarian for assistance in the diagnosis, treatment, and control of 
parasitism.

[46 FR 50948, Oct. 16, 1981, as amended at 47 FR 36418, Aug. 20, 1982; 
56 FR 50653, Oct. 8, 1991; 60 FR 55659, Nov. 2, 1995]



Sec.  520.1640  Oxibendazole suspension.

    (a) Specifications. The suspension contains 10 percent oxibendazole.
    (b) Sponsor. See 000069 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use in horses--(1) Amount. For use other than 
threadworms (Strongyloides westeri), 10 milligrams of oxibendazole per 
kilogram of body weight; for threadworms, 15 milligrams per kilogram of 
body weight.
    (2) Indications for use. For removal and control of large strongyles 
(Strongylus edentatus, S. equinus, S. vulgaris); small strongyles 
(species of the 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. Administer 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. Prepare individual doses to ensure that each animal receives the 
correct amount. Horses maintained on premises where reinfection is 
likely to occur should be re-treated in 6 to 8 weeks. Not for use in 
horses intended for food. Federal law restricts this drug to use by or 
on the order of a licensed veterinarian.

[45 FR 78119, Nov. 28, 1980, as amended at 47 FR 39812, Sept. 10, 1982; 
56 FR 50653, Oct. 8, 1991; 60 FR 55659, Nov. 2, 1995]



Sec.  520.1660  Oxytetracycline.



Sec.  520.1660a  Oxytetracycline and carbomycin in combination.

    (a) Specifications. (1) Oxytetracycline: The antibiotic substance 
produced by growth of Streptomyces rimosus or the 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. 000069 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. 1.0 gram of oxytetracycline and 1.0 gram carbomycin per 
gallon.
    (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. Administer for not more than 5 days; not for use in 
chickens producing eggs for human consumption; withdraw 24 hours before 
slaughter.



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. 000069 in Sec.  510.600(c) of this chapter.

[[Page 168]]

    (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.\1\
---------------------------------------------------------------------------

    \1\ These conditions are NAS/NRC reviewed and deemed effective. 
Applications for these uses need not include effectiveness data as 
specified by Sec.  514.111 of this chapter, but may require 
bioequivalency and safety information.
---------------------------------------------------------------------------

    (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.\1\
    (3) Federal law restricts this drug to use by or on the order of a 
licensed veterinarian.\1\



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 000069 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.
    (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 000069: Discontinue treatment 7 days prior 
to slaughter. Not for use in lactating dairy cattle.

[46 FR 32440, June 23, 1981, as amended at 50 FR 1045, Jan. 9, 1985; 63 
FR 70334, Dec. 21, 1998]



Sec.  520.1660d  Oxytetracycline hydrochloride soluble 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; 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).

[[Page 169]]

    (6) Each 1.32 grams of powder contains 1 gram of OTC HCl (packet: 
4.78 oz.; pail: 5 lb).
    (7) Each 18.1 grams of powder contains 1 gram of OTC HCl (packet: 
6.4 oz.; pails: 2 and 5 lb), each 272.2 grams (9.6 oz) of powder 
contains 204.8 grams of OTC HCl, each 907.2 grams (2 lb) of powder 
contains 686 grams of OTC HCl, each 2.26 kilograms (5 lb) of powder 
contains 1,715 grams of OTC HCl.
    (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; pails: 3.09 and 5 lb).
    (b) Sponsor. See sponsor numbers in Sec.  510.600(c) of this chapter 
as follows:
    (1) No. 000069 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. 046573 for use of OTC HCl concentration in paragraph (a)(4) 
of this section in chickens, turkeys, and swine.
    (3) No. 000010 for use of OTC HCl concentration in paragraph (a)(5) 
of this section in turkeys and chickens.
    (4) No. 057561 for use of OTC HCl concentration in paragraph (a)(6) 
of this section in chickens, turkeys, and swine.
    (5) No. 059130 for use of OTC HCl concentration in paragraph (a)(7) 
of this section in chickens, turkeys, swine, cattle, and sheep.
    (6) No. 053389 for use of OTC HCl concentrations in paragraph (a)(8) 
of this section in chickens, turkeys, swine, cattle, and sheep.
    (7) No. 061623 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 per gallon. 200 to 400 milligrams.
    (2) Indications for use. Control of infectious synovitis caused by 
Mycoplasma synoviae susceptible to oxytetracycline.
    (3) Limitations. Prepare a fresh solution daily. Administer 7 to 14 
days. Not to be used for more than 14 consecutive days. Use as sole 
source of drinking water. Do not use in birds producing eggs for human 
consumption.
    (B)(1) Amount per gallon. 400 to 800 milligrams.
    (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) Limitations. Prepare a fresh solution daily. Administer 7 to 14 
days. Not to be used for more than 14 consecutive days. Use as sole 
source of drinking water. Do not use in birds producing eggs for human 
consumption.
    (ii) Turkeys--(A)(1) Amount per gallon. 200 to 400 milligrams.
    (2) Indications for use. Control of hexamitiasis caused by Hexamita 
meleagridis susceptible to oxytetracycline.
    (3) Limitations. Prepare a fresh solution daily. Administer 7 to 14 
days. Not to be used for more than 14 consecutive days. Use as sole 
source of drinking water. Do not use in birds producing eggs for human 
consumption. Withdraw 5 days prior to slaughter those products sponsored 
by Nos. 000069, and 059130 in Sec.  510.600(c) of this chapter. Withdraw 
4 days prior to slaughter those products sponsored by No. 000010. Zero-
day withdrawal for those products sponsored by Nos. 046573, 053389, 
057561, and 061133.
    (B)(1) Amount per gallon. 400 milligrams.
    (2) Indications for use. Control of infectious synovitis caused by 
Mycoplasma synoviae susceptible to oxytetracycline.
    (3) Limitations. Prepare a fresh solution daily. Administer 7 to 14 
days. Not to be used for more than 14 consecutive days. Use as sole 
source of drinking water. Do not use in birds producing eggs for human 
consumption. Withdraw 5 days prior to slaughter those products sponsored 
by Nos. 000069, and 059130 in Sec.  510.600(c) of this chapter. Withdraw 
4 days prior to slaughter those products sponsored by No. 000010.

[[Page 170]]

Zero-day withdrawal for those products sponsored by Nos. 046573, 053389, 
057561, and 061133.
    (C)(1) Amount. 25 milligrams per pound of body weight.
    (2) Indications for use. Growing turkeys. Control of complicating 
bacterial organisms associated with bluecomb (transmissible enteritis, 
coronaviral enteritis) susceptible to oxytetracycline.
    (3) Limitations. Prepare a fresh solution daily. Administer 7 to 14 
days. Not to be used for more than 14 consecutive days. Use as sole 
source of drinking water. Do not use in birds producing eggs for human 
consumption. Withdraw 5 days prior to slaughter those products sponsored 
by Nos. 000069, and 059130 in Sec.  510.600(c) of this chapter. Withdraw 
4 days prior to salughter those products sponsored by No. 000010. Zero-
day withdrawal for those products sponsored by Nos. 046573, 053389, 
057561, and 061133.
    (iii) Swine--(A) Amount. 10 milligrams per pound of body weight 
daily.
    (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) Limitations. Prepare a fresh solution daily. Use as sole source 
of OTC. Administer up to 14 days; do not use for more than 14 
consecutive days; withdraw 5 days prior to slaughter those products 
sponsored by No. 059130 and zero days those products sponsored by No. 
000069. Administer up to 5 days; do not use for more than 5 consecutive 
days; withdraw zero days prior to slaughter those products sponsored by 
Nos. 046573, 053389, 057561, and 061133.
    (iv) Calves, beef cattle, and nonlactating dairy cattle--(A) Amount. 
10 milligrams per pound of body weight daily.
    (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) Limitations. Prepare a fresh solution daily. Administer up to 14 
days. Do not use for more than 14 consecutive days. Use as sole source 
of oxytetracycline. Do not administer this product with milk or milk 
replacers. Administer 1 hour before or 2 hours after feeding milk or 
milk replacers. Withdraw 5 days prior to slaughter. A withdrawal period 
has not been established for this product in preruminating calves. Do 
not use in calves to be processed for veal. A milk discard period has 
not been established for this product in lactating dairy cattle. Do not 
use in female dairy cattle 20 months of age or older.
    (v) Sheep--(A) Amount. 10 milligrams per pound of body weight daily.
    (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) Limitations. Prepare a fresh solution daily. Administer up to 14 
days. Do not use for more than 14 consecutive days. Use as sole source 
of oxytetracycline. Withdraw 5 days prior to slaughter.
    (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.
    (ii) Indications for use. Control and treatment of American and 
European foul brood caused by Bacillus larvae susceptible to 
oxytetracycline.
    (iii) Limitations. The drug is administered in 3 applications of 
sugar syrup or 3 dustings at 4- to 5-day intervals. 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.

[50 FR 32694, Aug. 14, 1985]

    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 on GPO Access.

[[Page 171]]



Sec.  520.1696  Penicillin oral dosage forms.



Sec.  520.1696a  Buffered penicillin powder, penicillin powder with buffered aqueous diluent.

    (a) Specifications. When reconstituted, each milliliter contains 
penicillin G procaine equivalent to 20,000, 25,000, 40,000, 50,000, 
80,000, or 100,000 units of penicillin G.
    (b) Sponsor. [Reserved]
    (c) Related tolerances. See Sec.  556.510 of this chapter.
    (d) Conditions of use. Chickens--It is used in drinking water as 
follows:
    (1) Amount. 100,000 units per gallon.
    (i) Indications for use. Treatment of chronic respiratory disease 
(air-sac infection) and bluecomb (nonspecific infectious enteritis).
    (ii) Limitations. As penicillin G procaine; not for use in laying 
chickens; prepare fresh solution daily; withdraw 1 day before slaughter; 
as sole source of penicillin.
    (2) Amount. 50,000 to 100,000 units per gallon.
    (i) Indications for use. Prevention of chronic respiratory disease 
(air-sac infection) and bluecomb (nonspecific infectious enteritis).
    (ii) Limitations. As penicillin G procaine; not for use in laying 
chickens; prepare fresh solution daily; withdraw 1 day before slaughter; 
as sole source of penicillin.

[57 FR 37326, Aug. 18, 1992]



Sec.  520.1696b  Penicillin G potassium in drinking water.

    (a) Specifications. When reconstituted, each milliliter contains 
penicillin G potassium equivalent to 20,000, 25,000, 40,000, 50,000, 
80,000, or 100,000 units of penicillin G.
    (b) Sponsors. See Nos. 046573, 053501, and 061623 in Sec.  
510.600(c) of this chapter.
    (c) Conditions of use. 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. Prepare concentrated stock solution for use with 
medication proportioners fresh every 24 hours. Prepare recommended use 
levels for gravity flow watering system fresh every 12 hours. For best 
results, treatment should be started at the first sign of infection. 
Discontinue treatment at least 1 day prior to slaughter. Not for use in 
turkeys producing eggs for human consumption.

[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]



Sec.  520.1696c  Penicillin V potassium for oral solution.

    (a) Specifications. When reconstituted, each milliliter contains 25 
milligrams (40,000 units) of penicillin V.
    (b) Sponsor. See No. 050604 in Sec.  510.600(c) of this chapter.
    (c) National Academy of Sciences/National Research Council (NAS/NRC) 
status. The conditions of use were NAS/NRC reviewed and found effective. 
Applications for these uses need not include effectiveness data as 
specified by Sec.  514.111 of this chapter, but may require 
bioequivalency and safety information.
    (d) Conditions of use. 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. Administer orally 1 to 2 hours prior to feeding for 
maximum absorption. 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]



Sec.  520.1696d  Penicillin V potassium 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. 017144, 050604, and 053501 in Sec.  
510.600(c) of this chapter.
    (c) National Academy of Sciences/National Research Council (NAS/NRC) 
status. These conditions of use were NAS/NRC reviewed and found 
effective. Applications for these uses need not include effectiveness 
data as specified by

[[Page 172]]

Sec.  514.111 of this chapter, but may require bioequivalency and safety 
information.
    (d) Conditions of use. 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. Administer orally 1 to 2 hours prior to feeding for 
maximum absorption. 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]



Sec.  520.1720  Phenylbutazone oral dosage forms.



Sec.  520.1720a  Phenylbutazone tablets and boluses.

    (a) Specifications. Each tablet contains 100, 200, or 400 
milligrams, or 1 gram of phenylbutazone. Each bolus contains 2 or 4 
grams of phenylbutazone.
    (b) Sponsor. See sponsor numbers in Sec.  510.600(c) of this 
chapter, as follows:
    (1) No. 000061 for use of 100- or 400-milligram or 1-gram tablets, 
or 2- or 4-gram boluses, in dogs and horses.
    (2) Nos. 000010 and 059130 for use of 100- or 200- milligrams or 1-
gram tablets in dogs and horses.
    (3) Nos. 000856, 000864, 058829 and 061623 for use of 100-milligram 
or 1-gram tablets in dogs and horses.
    (4) No. 055246 for use of 100-milligram tablets in dogs.
    (c) Conditions of use--(1) Dogs--(i) Amount. Twenty milligrams per 
pound of body weight daily.\1\
    (ii) Indications for use. The drug is used for the relief of 
inflammatory conditions associated with a musculoskeletal system.\1\
    (iii) Limitations. Administer in three divided doses daily. Do not 
exceed a total daily dose of 800 milligrams regardless of body weight. 
Administer at a relatively high dosage level for the first 48 hours and 
then reduce gradually to a maintenance dosage level with the lowest 
dosage maintained at a level capable of producing the desired clinical 
response. Federal law restricts this drug to use by or on the order of a 
licensed veterinarian.\1\
    (2) Horses--(i) Amount. One to two grams per 500 pounds weight 
daily.\1\
    (ii) Indications for use. This drug is used for the relief of 
inflammatory conditions associated with the musculoskeletal system.\1\
    (iii) Limitations. Do not exceed a daily dosage of 4 grams per day. 
Administer at a relatively high dosage level for the first 48 hours and 
then reduce gradually to a maintenance dosage level with the lowest 
dosage maintained at the level capable of producing the desired clinical 
response. Not for use in animals intended for food purposes. Federal law 
restricts this drug to use by or on the order of a licensed 
veterinarian.\1\
---------------------------------------------------------------------------

    \1\ See footnote 1 to Sec.  520.1660b.

[42 FR 44227, Sept. 2, 1977, as amended at 45 FR 10333, Feb. 15, 1980; 
45 FR 14023, Mar. 4, 1980; 46 FR 48642, Oct. 2, 1981; 47 FR 30968, July 
16, 1982; 50 FR 49372, Dec. 2, 1985; 52 FR 36023, Sept. 25, 1987; 54 FR 
22885, May 30, 1989; 55 FR 8462, Mar. 8, 1990; 59 FR 53585, Oct. 25, 
1994; 61 FR 8873, Mar. 6, 1996; 62 FR 61625, Nov. 19, 1997; 63 FR 36178, 
July 2, 1998; 66 FR 14073, Mar. 9, 2001; 66 FR 14316, Mar. 12, 2001; 66 
FR 15349, Mar. 19, 2001; 67 FR 67521, Nov. 6, 2002; 68 FR 4914, Jan. 31, 
2003]



Sec.  520.1720b  Phenylbutazone granules.

    (a) Specifications. The drug is in granular form. It is packaged to 
contain either 8 grams of phenylbutazone per package or 1 gram of 
phenylbutazone per package.
    (b) Sponsor. See 000061 in Sec.  510.600(c) for 8-gram package, see 
059320 for 1-gram package.
    (c) NAS/NRC status. The conditions of use have been NAS/NRC reviewed 
and found effective. NADA's for approval of drugs for these conditions 
of use need not include effectiveness data specified by Sec.  514.111 of 
this chapter, but may require bioequivalency and safety information.
    (d) Conditions of use--(1) Horses--(i) Amount. 1 to 2 grams per 500 
pounds of body weight, not to exceed 4 grams, daily, as required.
    (ii) Indications. For the treatment of inflammatory conditions 
associated with the musculoskeletal system.

[[Page 173]]

    (iii) Limitations. Administer orally by adding to a portion of the 
usual grain ration. Use a relatively high dose for the first 48 hours, 
then gradually reduce to a maintenance level at the lowest level capable 
of producing the desired clinical response. Treated animals should not 
be slaughtered for food use. Federal law restricts this drug to use by 
or on the order of a licensed veterinarian.

[46 FR 18960, Mar. 27, 1981, as amended at 46 FR 48642, Oct. 2, 1981; 57 
FR 2836, Jan. 24, 1992; 61 FR 8873, Mar. 6, 1996; 62 FR 61625, Nov. 19, 
1997; 65 FR 20731, Apr. 18, 2000]



Sec.  520.1720c  Phenylbutazone paste.

    (a) Specifications. The paste contains 20 percent phenylbutazone.
    (b) Sponsor. See 000061 and 010797 in Sec.  510.600(c) of this 
chapter.
    (c) NAS/NRC status. The conditions of use are NAS/NRC reviewed and 
found effective. Applications for these uses need not include 
effectiveness data as specified in Sec.  514.111 of this chapter, but 
may require bioequivalency and safety information.
    (d) 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. Use a relatively high dose for the first 48 hours, 
then gradually reduce to a maintenance level of the lowest level capable 
of producing the desired clinical response. Not for use in horses 
intended for food. 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]



Sec.  520.1720d  Phenylbutazone gel.

    (a) Specifications. Each 30 grams of gel contains 4 grams of 
phenylbutazone.
    (b) Sponsor. See No. 061623 in Sec.  510.600(c) of this chapter.
    (c) NAS/NRC status. The conditions of use are NAS/NRC reviewed and 
found effective. Applications for these uses need not include 
effectiveness data as specified in Sec.  514.111 of this chapter, but 
may require bioequivalency and safety information.
    (d) 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. Use a relatively high dose for the first 48 hours, 
then gradually reduce to a maintenance level at the lowest level capable 
of producing the desired clinical response. Not for use in horses 
intended for food. 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]



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 000009 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use. Horses and ponies--(1) Amount. One fluid 
ounce per 100 pounds of body weight.\1\
---------------------------------------------------------------------------

    \1\ These conditions are NAS/NRC reviewed and found effective. 
Applications for these uses need not include effectiveness data as 
specified by Sec.  514.111 of this chapter, but may require 
bioequivalency and safety information.
---------------------------------------------------------------------------

    (2) Indications for use. For removing ascarids (large roundworms, 
Parascaris equorum), bots (Gastrophilus spp.), small strongyles, large 
strongyles (Strongyles spp.), and pinworms (Oxyuris equi).\1\
    (3) Limitations. Administer by stomach tube or dose syringe after 
withholding feed overnight or for 8 to 10 hours. Provide water as usual. 
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

[[Page 174]]

disease. As with most anthelmintics, drastic cathartics and 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. Federal law restricts this drug to use by or on the order of a 
licensed veterinarian.\1\

[45 FR 52781, Aug. 8, 1980]



Sec.  520.1802b  Piperazine-carbon disulfide complex boluses.

    (a) Specifications. Each bolus contains 20 grams of piperazine-
carbon disulfide complex.
    (b) Sponsor. See 000009 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use: 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.\1\
    (2) Indications for use. For removing ascarids (large roundworms, 
Parascaris equorum), large strongyles (Strongylus spp.) bots 
(Gastrophilus spp.), small strongyles, and pinworms (Oxyuris equi).\1\
    (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.\1\

[45 FR 52782, Aug. 8, 1980]



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 000009 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use: Horses and ponies--(1) Amount. One fluid 
ounce per 100 pounds of body weight.
    (2) Indications for use. For removing ascarids (large roundworms, 
Parascaris equorum), bots (Gastrophilus spp.), small strongyles, and 
large strongyles (Strongylus spp.).
    (3) Limitations. See Sec.  520.1802a(c)(3).

[45 FR 52782, Aug. 8, 1980]



Sec.  520.1803  Piperazine citrate capsules.

    (a) Specifications. Piperazine citrate capsules contain piperazine 
citrate equivalent to 140 milligrams of piperazine base in each capsule.
    (b) Sponsor. See No. 021091 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use. (1) It is used in dogs and cats for the 
removal of large roundworms (Toxocara canis and Toxascaris leonina).
    (2) 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.
    (3) Severely debilitated animals should not be wormed except on the 
advice of a veterinarian.

[40 FR 13838, Mar. 27, 1975, as amended at 54 FR 38515, Sept. 19, 1989]



Sec.  520.1804  Piperazine phosphate capsules.

    (a) Specifications. Each capsule contains 120, 300, or 600 
milligrams of piperazine phosphate monohydrate.

[[Page 175]]

    (b) Sponsor. See No. 050906 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use--(1) Amount. 60 milligrams of piperazine 
phosphate monohydrate per pound of body weight.\1\
---------------------------------------------------------------------------

    \1\ These conditions are NAS/NRC reviewed and deemed effective. 
Applications for these uses need not include effectiveness data as 
specified by Sec.  514.111 of this chapter, but may require 
bioequivalency and safety information.
---------------------------------------------------------------------------

    (2) Indications for use--(i) Dogs. It is used for the removal of 
large roundworms (ascarids) Toxocara canis and Toxascaris leonina. \1\
    (ii) Cats. It is used for the removal of large roundworms (ascarids) 
Toxocara mystax and Toxacaris leonina. \1\
    (3) Limitations. Administer in animal's food or milk. For animals up 
to 1 year of age administer every 2 or 3 months; for animals over 1 year 
old, administer periodically as necessary. Consult your veterinarian for 
assistance in the diagnosis, treatment, and control of parasitism.\1\

[43 FR 6941, Feb. 17, 1978; 43 FR 9804, Mar. 10, 1978, as amended at 46 
FR 20158, Apr. 3, 1981]



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. Do not use this product to treat dogs weighing less 
than 2 pounds, unweaned pups, or pups under 5 weeks of age. Maximum 
efficacy against hookworms necessitates two doses in 1 day of treatment. 
The interval between the doses should be not less than 4 hours or more 
than 24 hours. Administer the first dose in the morning before feeding. 
Do not permit dog to chew tablet. Feed the dog between doses. Do not 
feed milk or other fatty foods during treatment. Retreatment may be 
needed in 7 to 28 days as determined by laboratory fecal examinations or 
in animals kept in known contaminated quarters. 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]



Sec.  520.1806  Piperazine monohydrochloride liquid.

    (a) Specifications. The product contains 4.77 percent piperazine 
monohydrochloride, equivalent to 3.35 percent piperazine base.
    (b) Sponsor. See Nos. 017135 and 063765 in Sec.  510.600(c) of this 
chapter.
    (c) Conditions of use--(1) Indications for use. For dogs for the 
removal of roundworms (Toxocara canis and Toxascaris leonina).
    (2) Dosage. Administer 20 to 30 milligrams of piperazine base per 
pound of 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 unweaned pups or animals 
less than three weeks of age. Consult your veterinarian for assistance 
in the diagnosis, treatment, and control of parasitism.

[47 FR 20758, May 14, 1982, as amended at 57 FR 48163, Oct. 22, 1992; 58 
FR 44611, Aug. 24, 1993; 59 FR 28769, June 3, 1994; 63 FR 8348, Feb. 19, 
1998]



Sec.  520.1807  Piperazine.

    (a) Specifications. A soluble powder or liquid containing piperazine 
dihydrochloride or dipiperazine sulfate,

[[Page 176]]

equivalent to 17, 34, or 230 grams of piperazine per pound or 100 
milliliters.
    (b) Sponsor. See 015565 in Sec.  510.600(c) of this chapter.
    (c) Related tolerances. See Sec.  556.513 of this chapter.
    (d) Conditions of use-- (1) Chickens--(i) Amount. 50 milligrams per 
bird under 6 weeks, 100 milligrams per bird over 6 weeks.
    (ii) Indications for use. For removal of large roundworm (Ascaridia 
spp.).
    (iii) Limitations. For use in drinking water or feed. Use as sole 
source of drinking water. Prepare fresh solution daily. Use as 1-day 
single treatment. Withdraw 14 days prior to slaughter. Do not use for 
chickens producing eggs for human consumption. Consult your veterinarian 
for assistance in the diagnosis, treatment, and control of parasitism.
    (2) Turkeys--(i) Amount. 100 milligrams per bird up to 12 weeks and 
200 milligrams per bird over 12 weeks.
    (ii) Indications for use. For removal of large roundworm (Ascaridia 
spp.).
    (iii) Limitations. For use in drinking water or feed. Use as sole 
source of drinking water. Prepare fresh solution daily. Use as 1-day 
single treatment. Withdraw 14 days prior to slaughter. Consult your 
veterinarian for assistance in the diagnosis, treatment, and control of 
parasitism.
    (3) Swine--(i) Amount. 50 milligrams per pound of body weight.
    (ii) Indications for use. For removal of large roundworm (Ascaris 
suum) and nodular worms (Oesophagostomum spp.).
    (iii) Limitations. For use in drinking water or feed. Use as sole 
source of drinking water. Prepare fresh solution daily. Use as 1-day 
single treatment. Withdraw 21 days prior to slaughter. Consult your 
veterinarian for assistance in the diagnosis, treatment, and control of 
parasitism.

[64 FR 23018, Apr. 29, 1999]



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. 000069 for use as in paragraphs (d)(1) and (d)(3) of this 
section.
    (2) No. 017800 for use as in paragraph (d)(4) of this section.
    (3) No. 036904 for use as in paragraph (d)(2) of this section.
    (4) No. 066104 for use as in paragraph (d)(3) of this section.
    (c) [Reserved]
    (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.
    (4) For control of legume (alfalfa, clover) and wheat pasture bloat 
in cattle. Administer in molasses block containing 6.6 percent 
poloxalene, at the rate of 0.8 ounce of block (1.5 grams of poloxalene) 
per 100 pounds of body weight per day. Provide access to blocks at least 
7 days before exposure to bloat-producing conditions.

[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]



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. 050112 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use--(1) Amount. 2 grams of polyoxyethylene (23) 
lauryl

[[Page 177]]

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]



Sec.  520.1855  Ponazuril.

    (a) Specifications. Each gram of paste contains 150 milligrams (mg) 
ponazuril.
    (b) Sponsor. See No. 000859 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use in horses--(1) Amount. 5 mg per kilogram body 
weight, daily for 28 days.
    (2) Indications for use. For the treatment of equine protozoal 
myeloencephalitis caused by Sarcocystis neurona.
    (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.

[66 FR 43774, Aug. 21, 2001]



Sec.  520.1870  Praziquantel tablets.

    (a) Specifications. Each dog tablet contains 34 milligrams (mg) of 
praziquantel; each cat tablet contains 11.5 or 23 mg of praziquantel.
    (b) Sponsor. See No. 000859 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use--(1) Dogs--(i) Indications for use. For 
removal of canine cestodes Dipylidium caninum and Taenia pisiformis. If 
labeled for use by or on the order of a licensed veterinarian, for 
removal of the canine cestode Echinococcus granulosus, and for removal 
and control of the canine cestode Echinococcus multilocularis.
    (ii) Dosage. Dogs 5 pounds and under, \1/2\ tablet (17 mg); 6 to 10 
pounds, 1 tablet (34 mg); 11 to 15 pounds, 1\1/2\ tablets (51 mg); 16 to 
30 pounds, 2 tablets (68 mg); 31 to 45 pounds, 3 tablets (102 mg); 46 to 
60 pounds, 4 tablets (136 mg); over 60 pounds, 5 tablets maximum (170 
mg).
    (iii) Limitations. Administer directly by mouth or crumbled and in 
feed. Not intended for use in puppies less than 4 weeks of age. For 
over-the-counter (OTC) use: Consult your veterinarian before 
administering tablets to weak or debilitated animals, and for assistance 
in the diagnosis, treatment, and control of parasitism. For prescription 
use: 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]



Sec.  520.1871  Praziquantel/pyrantel pamoate tablets.

    (a) Specifications. Each cat tablet contains 18.2 milligrams (mg) 
praziquantel with 72.6 mg pyrantel (as pyrantel pamoate).
    (b) Sponsor. See 000859 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use--(1) Cats--(i) Dosage. 1.5 to 1.9 pounds, 1/4 
tablet; 2 to 3 pounds, 1/2 tablet; 4 to 8 pounds, 1 tablet; 9 to 12 
pounds, 1 1/2 tablets; 13 to 16 pounds, 2 tablets.
    (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 1 month of age 
or weighing less than 1.5 pounds. May be given directly by mouth or in a 
small amount of food. Do not withhold food

[[Page 178]]

prior to or after treatment. If reinfection occurs, treatment may be 
repeated. Consult your veterinarian before giving to sick or pregnant 
animals. Consult your veterinarian for assistance in the diagnosis, 
treatment, and control of parasitism.
    (2) [Reserved]

[58 FR 58652, Nov. 3, 1993]



Sec.  520.1872  Praziquantel, pyrantel pamoate, and febantel tablets.

    (a) Specifications. Each 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.
    (b) Sponsor. See 000859 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.   Tablet no.
                                                     1            2
------------------------------------------------------------------------
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
27.7 to 33.6.................  61 to 74.......  ...........        2 1/2
34.0 to 40.9.................  75 to 90.......  ...........            3
41.3 to 47.2.................  91 to 104......  ...........        3 1/2
47.7 to 54.5.................  105 to 120.....  ...........            4
------------------------------------------------------------------------

    (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]



Sec.  520.1880  Prednisolone tablets.

    (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) Special considerations. (1) Clinical and experimental data have 
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 parturition 
followed by dystocia, fetal death, retained placenta, and metritis.
    (2) Do not use in viral infections. Systemic therapy with 
prednisolone is contraindicated in animals with peptic ulcer, corneal 
ulcer, and Cushingoid syndrome. The presence of diabetes, osteoporosis, 
predisposition to thrombophlebitis, hypertension, congestive heart 
failure, renal insufficiency, and active tuberculosis necessitates 
carefully controlled use. Some of the above conditions occur only rarely 
in dogs but should be kept in mind.
    (3) Anti-inflammatory action of corticosteroids may mask signs of 
infection.
    (d) Conditions of use--(1) Amount. Dogs: 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 in dogs as an anti-inflammatory 
agent.
    (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]



Sec.  520.1900  Primidone tablets.

    (a) Specifications. Each tablet contains 50 or 250 milligrams of 
primidone.

[[Page 179]]

    (b) Sponsor. See No. 000010 in Sec.  510.600(c) of this chapter for 
use of 250 milligram tablets; see No. 000856 in Sec.  510.600(c) of this 
chapter 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.\1\
---------------------------------------------------------------------------

    \1\ These conditions are NAS/NRC reviewed and deemed effective. 
Applications for these uses need not include effectiveness data as 
specified by Sec.  514.111 of this chapter, but may require 
bioequivalency and safety information.
---------------------------------------------------------------------------

    (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.\1\
    (3) Limitations. The tablets may be administered whole or crushed 
and mixed with the food. When convulsions are frequent, the dosage 
should be divided and administered at intervals. Reduction in dosage 
should be made gradually and never be abruptly discontinued. Do not use 
in feline species, as primidone appears to have a specific neurotoxicity 
in cats. Federal law restricts this drug to use by or on the order of a 
licensed veterinarian.\1\

[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]



Sec.  520.1920  Prochlorperazine, isopropamide sustained release capsules.

    (a) Specifications. Prochlorperazine, isopropamide sustained release 
capsules contain 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. 000069 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use. (1) The drug is used for the treatment of 
dogs in which gastrointestinal disturbances are associated with 
emotional stress.
    (2)(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.
    (3) For use only by or on the order of a licensed veterinarian.

[40 FR 13838, Mar. 27, 1975, as amended at 56 FR 50653, Oct. 8, 1991; 60 
FR 55659, Nov. 2, 1995]



Sec.  520.1921  Prochlorperazine, isopropamide, with neomycin sustained-release capsules.

    (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. 000069 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use--(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 treatment of dogs in which infectious 
bacterial gastroenteritis is associated with emotional stress.
    (3) Limitations. Do not continue medication longer than 5 days. 
Overdosage or prolonged administration may

[[Page 180]]

produce nephrotoxicity as manifested by albuminuria, presence of 
granular casts and depressed urinary output. If it is desirable to 
administer a vasoconstrictor, norepinephrine is the drug of choice. 
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]



Sec.  520.1962  Promazine hydrochloride.

    (a)(1) Chemical name. 10-[3-(Dimethylamino)propyl]phenothiazine 
monohydrochloride.
    (2) Specifications. Conforms to N.F. XII.
    (3) Sponsor. See No. 000856 in Sec.  510.600(c) of this chapter.
    (4) [Reserved]
    (5) Conditions of use. (i) The drug is used for quieting excitable, 
unruly, or intractable horses. It is administered at a dosage level of 
0.45 to 0.9 milligrams of promazine hydrochloride per pound of body 
weight mixed with an amount of feed that will be readily consumed.
    (ii) Do not use in horses intended for food.
    (iii) Federal law restricts this drug to use by or on the order of a 
licensed veterinarian.
    (b) [Reserved]

[40 FR 13838, Mar. 27, 1975, as amended at 43 FR 55386, Nov. 28, 1978; 
59 FR 5705, Feb. 8, 1994]



Sec.  520.2002  Propiopromazine hydrochloride.

    (a) Chemical name. 1-Propanone, 1-[10-[3-(dimethylamino) propyl] 
phenothiazine-2-yl]-, monohydrochloride.
    (b) Specifications. The drug is administered in a chewable tablet 
containing 10 to 20 milligrams of propiopromazine hydrochloride.
    (c) Sponsor. See No. 000856 in Sec.  510.600(c) of this chapter.
    (d) Conditions of use. (1) The drug is intended for oral 
administration to dogs as a tranquilizer. It is used 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.
    (2) It is administered at the rate of 0.5 to 2 milligrams of 
propiopromazine hydrochloride per pound of body weight once or twice 
daily depending upon the degree of tranquilization desired.
    Note: Not for use with organophosphates and/or procaine 
hydrochloride, as phenothiazine may potentiate the toxicity of 
organophosphates and the activity of procaine hydrochloride. Overdosage 
may produce significant depression.
    (3) For use only by or on the order of a licensed veterinarian.

[40 FR 13838, Mar. 27, 1975, as amended at 46 FR 60570, Dec. 11, 1981; 
61 FR 5506, Feb. 13, 1996]



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]



Sec.  520.2042  Pyrantel pamoate tablets.

    (a) Specifications. Each tablet contains pyrantel pamoate equivalent 
to

[[Page 181]]

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 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. 000069 and 059130 for use of the product described in 
paragraph (a)(1) as in paragraph (d)(1) of this section.
    (2) Nos. 000069, 010237, and 059130 for use of the products 
described in paragraph (a)(2) 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 infections 
from the following mature parasites: Large strongyles (Strongylus 
vulgaris, S. edentatus, S. equinus), small strongyles, pinworms 
(Oxyuris), and large roundworms (Parascaris).
    (iii) Limitations. Not for use in horses and ponies to be 
slaughtered for food purposes. 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 Toxascarias 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]

[[Page 182]]



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).
    (b) Sponsors. See sponsors in Sec.  510.600(c) of this chapter.
    (1) No. 000069 for use of product described in paragraph (a)(1) of 
this section.
    (2) No. 059130 for use of product described in paragraph (a)(2) of 
this section.
    (c) Conditions of use. It is used in horses and ponies as follows:
    (1) Amount. Equivalent of 3 milligrams pyrantel base per pound of 
body weight.
    (2) Indications for use. 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).
    (3) Limitations. Administer as single dose by depositing paste on 
dorsum of the tongue using the dose syringe. Not for use in horses 
intended for food. It is recommended that severely debilitated animals 
not be treated with this preparation. Consult your veterinarian for 
assistance in the diagnosis, treatment, and control of parasitism.

[47 FR 47377, Oct. 26, 1982; 48 FR 3367, Jan. 25, 1983, as amended at 68 
FR 13627, Mar. 20, 2003]



Sec.  520.2045  Pyrantel tartrate powder; pyrantel tartrate pellets.

    (a) Specifications. (1) Pyrantel tartrate powder horse wormer 
contains 11.3 percent and swine wormer 10.6 percent pyrantel tartrate.
    (2) Pyrantel tartrate pellets colt and horse wormer contains 1.25 
percent pyrantel tartrate.
    (b) Sponsor. (1) See No. 000069 in Sec.  510.600(c) of this chapter 
for conditions of use provided for in paragraphs (d) (1) and (2) of this 
section.
    (2) See No. 060594 in Sec.  510.600(c) of this chapter, for 
conditions of use provided for in paragraph (d)(3) of this section.
    (c) Related tolerances. See Sec.  556.560 of this chapter.
    (d) Conditions of use. It is used in: (1) Horses and ponies:
    (i) For the removal and control of infections from the following 
mature parasites: Large strongyles (Strongylus vulgaris, Strongylus 
edentatus, Strongylus equinus), small strongyles (Trichonema spp., 
Triodontophorus), pinworms (Oxyuris), and large roundworms (Parascaris).
    (ii) It is administered as a single dose at 0.57 gram of pyrantel 
tartrate per 100 pounds of body weight mixed with the usual grain 
ration.
    (iii) It is recommended that severely debilitated animals not be 
treated with this drug. Do not administer by stomach tube or dose 
syringe. The drug should be used immediately after the package is 
opened.
    (iv) Warning: Not for use in horses and ponies to be slaughtered for 
food purposes.
    (2) Swine:
    (i) For the removal and control of large roundworms (Ascaris suum) 
and nodular worm (Oesophagostomum) infections.
    (ii) It is added to feed at 0.4 gram pyrantel tartrate per pound of 
nonpelleted 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.
    (iii) Fast pigs over night for optimum results. Water should be made 
available to animals during fasting and treatment periods. Consult 
veterinarian before using in severely debilitated animals. The drug 
should be used immediately after the package is opened.
    (iv) Warning: Do not treat within 24 hours of slaughter.
    (3) Horses and colts:
    (i) For the removal and control of infections from the following 
mature parasites: Large strongyles (Strongylus vulgaris, Strongylus 
edentatus, Strongylus equinus), small strongyles (Trichonema spp., 
Triodontophorus), pinworms (Oxyuris), and large roundworms (Parascaris).
    (ii) It is administered as a single dose at 12.5 milligrams of 
pyrantel tartrate per 2.2 pounds of body weight mixed with the usual 
grain ration.

[[Page 183]]

    (iii) It is recommended that severely debilitated animals not be 
treated with this drug.
    (iv) Warning: Do not use in horses or colts intended for food.

[40 FR 13838, Mar. 27, 1975, as amended at 59 FR 28769, June 3, 1994]



Sec.  520.2087  Roxarsone soluble powder.

    (a) Specifications. Each ounce (avoirdupois) of soluble powder 
contains 21.7 grams of roxarsone (monosodium 3-nitro-4-
hydroxyphenylarsonate).
    (b) Sponsor. See No. 046573 in Sec.  510.600(c) of this chapter.
    (c) Related tolerances. See Sec.  556.60 of this chapter.
    (d) NAS/NRC status. These conditions of use are NAS/NRC reviewed and 
found effective. NADA's for these uses need not include effectiveness 
data as specified by Sec.  514.111 of this chapter, but may require 
bioequivalency and safety information.
    (e) Conditions of use--(1) Growing chickens and growing turkeys--(i) 
Amount. 0.002 percent roxarsone in drinking water (one packet per each 
250 gallons of drinking water).
    (ii) Indications for use. For increased rate of weight gain, 
improved feed efficiency, and improved pigmentation.
    (iii) Limitations. Administer continuously throughout growing 
period. Withdraw 5 days before slaughter. Use as sole source of organic 
arsenic.
    (2) Swine--(i) Amount. 0.01 percent roxarsone in drinking water (one 
packet per each 50 gallons of drinking water); or 30 milliliters of a 
1.55 percent roxarsone solution (one packet per 3 pints of water) per 50 
pounds of body weight as a drench.
    (ii) Indications for use. As an aid in the treatment of swine 
dysentery (hemorrhagic enteritis or bloody scours).
    (iii) Limitations. Administer drinking water continuously for not 
more than 6 days. Administer drench once daily for 1 or 2 days. If no 
improvement is observed, consult a veterinarian. Treatment may be 
repeated after 5 days. Withdraw 5 days before slaughter. Use as sole 
source of organic arsenic.

[46 FR 41039, Aug. 14, 1981, as amended at 55 FR 8460, Mar. 8, 1990; 57 
FR 8577, Mar. 11, 1992]



Sec.  520.2088  Roxarsone tablets.

    (a)(1) Specifications. Each tablet contains 36 milligrams of 
roxarsone (3-nitro-4-hydroxyphenylarsonic acid).
    (2) Sponsor. See No. 046573 in Sec.  510.600(c) of this chapter.
    (3) Related tolerances. See Sec.  556.60 of this chapter.
    (4) NAS/NRC status. The weight gain, feed efficiency, and 
pigmentation claims are NAS/NRC reviewed and found effective. NADA's for 
these uses need not include effectiveness data as specified by Sec.  
514.111 of this chapter, but may require bioequivalency and safety 
information.
    (5) Conditions of use--(i) Growing chickens and growing turkeys--(a) 
Amount. Dissolve 2 tablets in each gallon of drinking water (0.002 
percent roxarsone).
    (b) Indications for use. For increased rate of weight gain, improved 
feed efficiency, and improved pigmentation.
    (c) Limitations. Administer continuously throughout growing period. 
Withdraw 5 days before slaughter. Use as sole source of organic arsenic.
    (ii) Growing chickens--(a) Amount. Dissolve 8 tablets in each gallon 
of drinking water (0.008 percent roxarsone).
    (b) Indications for use. As an aid in the prevention of coccidiosis 
due to Eimeria tenella.
    (c) Limitations. Administer for not more than 10 consecutive days. 
Treatment may be repeated after 5 days off medication. Withdraw 5 days 
before slaughter. Use as sole source of organic arsenic.
    (b)(1) Specifications. Each tablet contains 400 milligrams of 
roxarsone (3-nitro-4-hydroxyphenylarsonic acid).
    (2) Sponsor. See No. 046573 in Sec.  510.600(c) of this chapter.
    (3) Related tolerances. See Sec.  556.60 of this chapter.
    (4) NAS/NRC status. These conditions are NAS/NRC reviewed and found 
effective. NADA's for these uses need not include effectiveness data as 
specified by Sec.  514.111 of this chapter, but may require 
bioequivalency and safety information.
    (5) Conditions of use--(i) Swine--(a) Amount. 1 tablet (400 
milligrams) per gallon of drinking water for no more than 6 days, or 1 
tablet (400 milligrams)

[[Page 184]]

per 2 fluid ounces of warm water per 50 pounds of body weight as a 
drench once daily for 1 to 2 days.
    (b) Indications for use. As an aid in the treatment of swine 
dysentery (hemorrhagic enteritis or bloody scours).
    (c) Limitations. Treatment may be repeated after 5 days off 
medication. If no improvement is observed, consult a veterinarian. 
Treated animals must consume enough medicated water to provide a 
therapeutic dose. Withdraw 5 days before slaughter. Use as sole source 
of organic arsenic.
    (ii) [Reserved]
    (c)(1) Specifications. Each tablet contains 72 milligrams of 
roxarsone (3-nitro-4-hydroxyphenylarsonic acid).
    (2) Sponsor. See No. 046573 in Sec.  510.600(c) of this chapter.
    (3) Related tolerances. See Sec.  556.60 of this chapter.
    (4) Conditions of use in growing chickens and growing turkeys--(i) 
Amount. 1 tablet in each gallon of drinking water (0.002 percent 
roxarsone).
    (ii) Indications for use. For improved rate of weight gain, improved 
feed efficiency, and improved pigmentation.
    (iii) Limitations. Administer continuously throughout growing 
period. Do not administer to chickens producing eggs for human 
consumption. Withdraw 5 days before slaughter. Use as sole source of 
organic arsenic. Overdosage or the lack of water intake may result in 
weakness or paralysis of legs.

[46 FR 41040, Aug. 14, 1981, as amended at 46 FR 42448, Aug. 21, 1981; 
47 FR 15238, Apr. 9, 1982; 55 FR 8460, Mar. 8, 1990; 57 FR 8577, Mar. 
11, 1992; 58 FR 65664, Dec. 16, 1993; 65 FR 10705, Feb. 29, 2000]



Sec.  520.2089  Roxarsone liquid.

    (a) Specifications. Each teaspoon (5 milliliters) of solution 
contains 72 milligrams of roxarsone (3-nitro-4-hydroxyphenylarsonic 
acid).
    (b) Sponsor. See No. 046573 in Sec.  510.600(c) of this chapter.
    (c) Related tolerances. See Sec.  556.60 of this chapter.
    (d) Conditions of use in growing chickens and growing turkeys--(1) 
Amount. 1 teaspoon (5 milliliters) to each gallon of drinking water 
(0.002 percent roxarsone).
    (2) Indications for use. For improved rate of weight gain, improved 
feed efficiency, and improved pigmentation.
    (3) Limitations. Administer continuously throughout growing period. 
Do not administer to chickens producing eggs for human consumption. 
Withdraw 5 days before slaughter. Use as sole source of organic arsenic. 
Overdosage or the lack of water intake may result in weakness or 
paralysis of legs.

[58 FR 65665, Dec. 16, 1993, as amended at 65 FR 10705, Feb. 29, 2000]



Sec.  520.2098  Selegiline hydrochloride tablets.

    (a) Specifications. Each tablet contains either 2, 5, 10, 15, or 30 
milligrams of selegiline hydrochloride.
    (b) Sponsor. See No. 000069 in Sec.  510.600(c) of this chapter.
    (c) [Reserved]
    (d) Conditions of use--Dogs--(1) Dosage. 1 milligram per kilogram 
(0.45 milligram per pound) of body weight.
    (i) Indications for use. For control of clinical signs associated 
with uncomplicated pituitary-dependent hyperadrenocorticism in dogs.
    (ii) Limitations. Administer orally once daily. If no improvement in 
clinical signs or physical examination findings after 2 months of 
therapy, increase dose to a maximum of 2 milligrams per kilogram once 
daily. Federal law restricts this drug to use by or on the order of a 
licensed veterinarian.
    (2) Dosage. 0.5 to 1.0 milligram per kilogram of body weight once 
daily.
    (i) Indications for use. For the control of clinical signs 
associated with canine cognitive dysfunction syndrome.
    (ii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

[62 FR 34632, June 27, 1997; 62 FR 55159, Oct. 23, 1997, as amended at 
63 FR 29551, June 1, 1998; 64 FR 2122, Jan. 13, 1999]



Sec.  520.2100  Selenium, vitamin E capsules.

    (a) Specifications. The capsules contain 2.19 milligrams of sodium 
selenite (equivalent to 1 milligram of selenium) and 56.2 milligrams of 
vitamin E (68 I.U.) (as d-alpha tocopheryl acid succinate) or 0.548 
milligram of sodium selenite (equivalent to .25 milligram of selenium 
and 14 milligrams of vitamin E

[[Page 185]]

(17 I.U.) (as d-alpha tocopheryl acid succinate.)
    (b) Sponsor. See No. 000061 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use. (1) The drug is intended for use as an aid in 
alleviating and controlling inflammation, pain, and lameness associated 
with certain arthropathies in dogs.
    (2) The capsules are administered orally with the larger capsules 
administered at a dosage level of 1 capsule per 20 pounds of body weight 
to a maximum of 5 capsules with the dosage repeated at 3 day intervals 
until a satisfactory therapeutic response is observed. A maintenance 
dosage is then administered consisting of 1 capsule per 40 pounds of 
body weight, with a minimum of 1 capsule per 40 pounds of body weight, 
with a minimum of 1 capsule, given every 3 days, or 7 days, or longer, 
as required to maintain improvement or an asymptomatic condition. For 
dogs under 20 pounds of body weight, the small capsules are administered 
orally at a dosage level of 1 per 5 pounds of body weight with a minimum 
of 1 capsule which dosage is repeated at 3 day intervals until a 
satisfactory response is observed then a maintenance regimen is 
initiated with 1 capsule per 10 pounds of body weight, minimum of 1 
capsule, every 3 days, or 7 days, or longer as required to maintain 
continued improvement or an asymptomatic condition.
    (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 52 FR 7832, Mar. 13, 1987; 52 
FR 9756, Mar. 26, 1987]



Sec.  520.2122  Spectinomycin dihydrochloride oral solution.

    (a) Specifications. The spectinomycin dihydrochloride pentahydrate 
used in manufacturing the drug is the antibiotic substance produced by 
growth of Streptomyces flavopersicus (var. Abbott) or the same 
antibiotic substance produced by any other means. The drug is packaged 
as an aqueous solution containing 50 milligrams of spectinomycin 
activity per milliliter.
    (b) Sponsors. (1) See No. 059130 in Sec.  510.600(c) of this 
chapter.
    (2) See No. 000856 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use. (1) It is used for the treatment and control 
of infectious bacterial enteritis (white scours) associated with E. coli 
in pigs under 4 weeks of age.
    (2) It is administered orally at the rate of 50 milligrams per 10 
pounds body weight twice daily for 3 to 5 days.
    (3) Do not administer to pigs over 15 pounds body weight or over 4 
weeks of age. Do not administer within 21 days of slaughter.

[40 FR 13838, Mar. 27, 1975, as amended at 45 FR 56798, Aug. 26, 1980; 
46 FR 60570, Dec. 11, 1981; 61 FR 5506, Feb. 13, 1996; 65 FR 45877, July 
26, 2000]



Sec.  520.2123  Spectinomycin dihydrochloride pentahydrate oral dosage forms.



Sec.  520.2123a  Spectinomycin dihydrochloride pentahydrate tablets.

    (a) Specifications. The spectinomycin dihydrochloride pentahydrate 
used in manufacturing the drug is the antibiotic substance produced by 
growth of Streptomyces flavopersicus (var. Abbott) or the same 
antibiotic substance produced by any other means.
    (b) Sponsor. See No. 061623 in Sec.  510.600(c) of this chapter.
    (c) Special considerations. The quantities of spectinomycin cited in 
this section refer to the equivalent weight of base activity for the 
drug.
    (d) Conditions of use. (1) The tablets are administered orally to 
dogs in the treatment of infectious diarrhea and gastroenteritis caused 
by organisms susceptible to spectinomycin.
    (2) The drug is administered orally to provide 10 milligrams per 
pound of body weight twice daily. The tablets may be placed in the 
animal's mouth or crushed and administered in milk or in the feed. 
Dosage may be continued for 4 consecutive days. Should no improvement be 
observed, discontinue drug and redetermine diagnosis.
    (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 47 FR 14149, Apr. 2, 1982; 66 
FR 14073, Mar. 9, 2001; 68 FR 4915, Jan. 31, 2003]

[[Page 186]]



Sec.  520.2123b  Spectinomycin dihydrochloride pentahydrate soluble powder.

    (a) Specifications. The spectinomycin dihydrochloride pentahydrate 
used in manufacturing the drug is the antibiotic substance produced by 
growth of Streptomyces flavopersicus (var. Abbott) or the same 
antibiotic substance produced by any other means.
    (b) Sponsor. See No. 061623 in Sec.  510.600(c) of this chapter.
    (c) Special considerations. The quantities of spectinomycin cited in 
this section refer to the equivalent weight of base activity for the 
drug.
    (d) Related tolerances. See Sec.  556.600 of this chapter.
    (e) Conditions of use. (1) It is administered in the drinking water 
of growing chickens at 2 grams of spectinomycin 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 It is administered as an aid in the 
prevention or control of losses due to CRD associated with M. 
gallisepticum (PPLO). Do not administer to laying chickens. Do not 
administer within 5 days of slaughter.
    (2) It is administered in the drinking water of floor-raised broiler 
chickens at 0.5 gram of spectinomycin 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. It is administered for increased rate of 
weight gain and improved feed efficiency. Do not administer to laying 
chickens. Do not administer within 5 days of slaughter.
    (3) It is administered in drinking water of broiler chickens at 1 
gram of spectinomycin per gallon of water as the only source of drinking 
water for the first 3 to 5 days of life as an aid in controlling 
infectious synovitis due to Mycoplasma synoviae. Do not administer to 
laying chickens. Do not administer within 5 days of slaughter.

[40 FR 13838, Mar. 27, 1975, as amended at 45 FR 56798, Aug. 26, 1980; 
66 FR 14073, Mar. 9, 2001; 68 FR 4915, Jan. 31, 2003]



Sec.  520.2150  Stanozolol oral dosage forms.



Sec.  520.2150a  Stanozolol tablets.

    (a) Specifications. Each tablet contains 2 milligrams of stanozolol.
    (b) Sponsor. No. 000009 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use. (1) Used as an anabolic steroid treatment in 
dogs and cats.
    (2) Administered orally to cats and small breeds of dogs, \1/2\ to 1 
tablet twice daily for several weeks; to large breeds of dogs, 1 to 2 
tablets twice daily for several weeks. The tablets may be crushed and 
administered in feed.
    (3) Federal law restricts this drug to use by or on the order of a 
licensed veterinarian.

[40 FR 46101, Oct. 6, 1975, as amended at 42 FR 36995, July 19, 1977. 
Redesignated at 50 FR 38114, Sept. 20, 1985, and amended at 55 FR 23076, 
June 6, 1990]



Sec.  520.2150b  Stanozolol chewable tablets.

    (a) Specifications. Each chewable tablet contains 2 milligrams of 
stanozolol.
    (b) Sponsor. No. 000009 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use. (1) Used as an anabolic steroid treatment in 
dogs.
    (2) Administered orally to small breeds of dogs, \1/2\ to 1 tablet 
twice daily for several weeks; to large breeds of dogs, 1 to 2 tablets 
twice daily for several weeks.
    (3) Federal law restricts this drug to use by or on the order of a 
licensed veterinarian.

[50 FR 38114, Sept. 20, 1985, as amended at 55 FR 23076, June 6, 1990]



Sec.  520.2158  Streptomycin/dihydrostreptomycin oral dosage forms.



Sec.  520.2158a  Streptomycin sulfate oral solution.

    (a) Specifications. Solution containing 25 percent streptomycin 
sulfate.
    (b) Sponsor. See Nos. 033008 and 055462 in Sec.  510.600(c) of this 
chapter.
    (c) Related tolerances. See Sec.  556.610 of this chapter.

[[Page 187]]

    (d) Conditions of use. Use in drinking water as follows:
    (1) Calves and swine--(i) Amount. 10 to 15 milligrams per pound (mg/
pound) of body weight (1.0 to 1.5 grams per gallon).
    (ii) Indications for use. Treatment of bacterial enteritis caused by 
Escherichia coli and Salmonella spp. susceptible to streptomycin.
    (iii) Limitations. Calves: Do not administer for more than 5 days. 
Swine: Do not administer for more than 4 days. Prepare fresh solution 
daily. Calves: Withdraw 2 days before slaughter. As sole source of 
streptomycin. Warning: Certain strains of bacteria may develop a 
tolerance for streptomycin. Consult a veterinarian or animal pathologist 
for diagnosis.
    (2) Chickens--(i) Amount. 10 to 15 mg/pound of body weight (0.6 to 
0.9 grams per gallon).
    (ii) Indications for use. Treatment of nonspecific infectious 
enteritis caused by organisms susceptible to streptomycin.
    (iii) Limitations. Chickens: Do not administer for more than 5 days. 
Withdraw 4 days before slaughter. Do not administer to chickens 
producing eggs for human consumption. Prepare fresh solution daily. As 
sole source of streptomycin. Warning: Certain strains of bacteria may 
develop a tolerance for streptomycin. Consult a veterinarian or animal 
pathologist for diagnosis.

[57 FR 37327, Aug. 18, 1992, as amended at 58 FR 47211, Sept. 8, 1993; 
63 FR 51821, Sept. 29, 1998]



Sec.  520.2158b  Dihydrostreptomycin tablets.

    (a) Specifications. Each tablet contains 37.5 milligrams 
dihydrostreptomycin (as the sulfate) with 375 milligrams chlorhexidine 
dihydrochloride.
    (b) Sponsor. See No. 000856 in Sec.  510.600(c) of this chapter.
    (c) Related tolerances. See Sec. Sec.  556.120 and 556.200 of this 
chapter.
    (d) Conditions of use. Calves--(1) Amount. 150 milligrams of 
dihydrostreptomycin and 1.5 grams of chlorhexidine dihydrochloride per 
100 pounds of body weight per day.
    (2) Indications for use. Treatment of bacterial scours in calves.
    (3) Limitations. Administer orally once a day for 5 days; withdraw 3 
days before slaughter.

[57 FR 37327, Aug. 18, 1992; 57 FR 42623, Sept. 15, 1992]



Sec.  520.2158c  Dihydrostreptomycin oral suspension.

    (a) Specifications. Each milliliter contains 1.25 milligrams 
dihydrostreptomycin (as the sulfate) with 12.5 milligrams chlorhexidine 
dihydrochloride.
    (b) Sponsor. See No. 000856 in Sec.  510.600(c) of this chapter.
    (c) Related tolerances. See Sec. Sec.  556.120 and 556.200 of this 
chapter.
    (d) Conditions of use. Calves--(1) Amount. 150 milligrams of 
dihydrostreptomycin and 1.5 grams of chlorhexidine dihydrochloride per 
100 pounds of body weight per day.
    (2) Indications for use. Treatment of bacterial scours in calves.
    (3) Limitations. Administer orally once a day for 5 days; withdraw 3 
days before slaughter.

[57 FR 37327, Aug. 18, 1992]



Sec.  520.2160  Styrylpyridinium, diethylcarbamazine oral dosage forms.



Sec.  520.2170  Sulfabromomethazine sodium boluses.

    (a) Specifications. Each bolus contains 15 grams of 
sulfabromomethazine sodium.
    (b) Related tolerance. See Sec.  556.620 of this chapter.
    (c) Sponsor. See No. 050604 in Sec.  510.600(c) of this chapter.
    (d) NAS/NRC status. These conditions of use are NAS/NRC reviewed and 
found effective. NADA's for these uses need not include effectiveness 
data as specified by Sec.  514.111 of this chapter, but may require 
bioequivalency and safety information.
    (e) Conditions of use. Cattle--(1) Amount. 90 milligrams per pound 
body weight.
    (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

[[Page 188]]

metritis and acute mastitis caused by Streptococcus spp.
    (3) Limitations. Administer orally; repeat in 48 hours if necessary; 
milk taken from animals within 96 hours (8 milkings) of latest treatment 
must not be used for food; do not administer within 18 days of 
slaughter; discontinue use if hematuria, crystalluria or severe 
depression are noticed; if signs persist after 2 or 3 days consult a 
veterinarian.

[47 FR 30243, July 13, 1982, as amended at 62 FR 63270, Nov. 28, 1997]



Sec.  520.2184  Sodium sulfachloropyrazine monohydrate.

    (a) Chemical name. 2-Sulfamido-6-chloroxyrazine, sodium.
    (b) Sponsor. See Nos. 053501 in Sec.  510.600(c) of this chapter.
    (c) Related tolerances. See Sec.  556.625 of this chapter.
    (d) Conditions of use. It is used in the drinking water of broilers, 
breeder flocks, and replacement chickens as follows:
    (1) Amount. 0.03 percent.
    (2) Indications for use. Treatment of coccidiosis.
    (3) Limitations. Administer in drinking water for 3 days as sole 
source of drinking water and sulfonamide medication; withdraw 4 days 
prior to slaughter; not to be administered to chickens producing eggs 
for human consumption.

[40 FR 13838, Mar. 27, 1975, as amended at 50 FR 41489, Oct. 11, 1985; 
54 FR 12188, Mar. 24, 1989; 55 FR 8460, Mar. 8, 1990; 64 FR 15684, Apr. 
1, 1999; 67 FR 78355, Dec. 24, 2002]



Sec.  520.2200  Sulfachlorpyridazine oral dosage forms.



Sec.  520.2200a  Sulfachlorpyridazine bolus.

    (a) Chemical name. N'-6-(Chloro-3-pyridazinyl) sulfanilamide.
    (b) Specifications. Melting point range: 190 [deg]C to 191 [deg]C.
    (c) Sponsor. See No. 053501 in Sec.  510.600(c) of this chapter.
    (d) Related tolerances. See Sec.  556.630 of this chapter.
    (e) Conditions of use. It is used in calves as follows:
    (1) Amount. 30 to 45 milligrams per pound body weight per day.
    (2) Indications for use. Treatment of diarrhea caused or complicated 
by E. coli (colibacillosis).
    (3) Limitations. Administer in a bolus containing 2 grams of 
sulfachlorpyridazine for 1 to 5 days in divided doses twice daily; 
treated calves must not be slaughtered for food during treatment or for 
7 days after the last treatment.

[40 FR 13838, Mar. 27, 1975, as amended at 50 FR 41489, Oct. 11, 1985]



Sec.  520.2200b  Sulfachlorpyridazine medicated milk and drinking water.

    (a) Chemical name. N'-(6-Chloro-3-pyridazinyl) sulfanilamide.
    (b) Specifications. Melting point range: 190 [deg]C to 191 [deg]C.
    (c) Sponsor. See No. 053501 in Sec.  510.600(c) of this chapter.
    (d) Related tolerances. See Sec.  556.630 of this chapter.
    (e) Conditions of use. It is used as follows:
    (1) Calves--(i) Amount. 30 to 45 milligrams per pound body weight 
per day.
    (ii) Indications for use. Treatment of diarrhea caused or 
complicated by E. coli (colibacillosis).
    (iii) Limitations. Administer as the sodium salt of 
sulfachlorpyridazine in milk or milk-replacer formulations for 1 to 5 
days in divided doses twice daily; treated calves must not be 
slaughtered for food during treatment or for 7 days after the last 
treatment.
    (2) Swine--(i) Amount. 20 to 35 milligrams per pound body weight per 
day.
    (a) Indications for use. Treatment of diarrhea caused or complicated 
by E. coli (colibacillosis).
    (b) Limitations. Administer as the sodium salt of 
sulfachlorpyridazine in drinking water for 1 to 5 days; for individual 
treatment, administer orally in divided doses twice daily; treated swine 
must not be slaughtered for food during treatment or for 4 days after 
the last treatment.
    (ii) Amount. 20 to 35 milligrams per pound body weight per day.
    (a) Indications for use. Treatment of diarrhea caused or complicated 
by E. coli (colibacillosis).
    (b) Limitations. Administer individually in an oral suspension 
containing 50 milligrams of sulfachlorpyridazine per milliliter in 
divided doses twice

[[Page 189]]

daily for 1 to 5 days; treated swine must not be slaughtered for food 
during treatment or for 4 days after the last treatment.

[40 FR 13838, Mar. 27, 1975, as amended at 50 FR 41489, Oct. 11, 1985]



Sec.  520.2200c  Sulfachlorpyridazine tablets.

    (a) Specifications. Sulfachlorpyridazine tablets contain 250 
milligrams of sulfachlorpyridazine per tablet.
    (b) Sponsor. See No. 053501 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use. (1) The drug is used in dogs as a broad 
spectrum antibacterial agent to aid in the treatment of infectious 
tracheobronchitis and infections caused by E. coli. It can also be used 
in the treatment of infections caused by other gram-positive and gram-
negative organisms that are susceptible to sulfonamide therapy.
    (2) It is administered orally at a dosage level of 500 milligrams 
per 10 to 15 pounds of body weight daily, in two or three divided doses.
    (3) The administration of the drug should be discontinued if a 
response is not noted within 7 to 10 days.
    (4) Federal law restricts this drug to use by or on the order of a 
licensed veterinarian.

[43 FR 36622, Aug. 18, 1978, as amended at 50 FR 41489, Oct. 11, 1985]



Sec.  520.2220  Sulfadimethoxine oral dosage forms.



Sec.  520.2220a  Sulfadimethoxine oral solution and soluble powder.

    (a) Approvals. (1) For oral solution containing 12.5 percent (3.75 
grams per ounce) sulfadimethoxine, see Nos. 000010, 000069, 051259, 
057561, and 059130 in Sec.  510.600(c).
    (2) For soluble powder, each package containing the equivalent of 
94.6 grams of sulfadimethoxine (as the sodium salt), see Nos. 000069, 
051259, 057561, and 059130 in Sec.  510.600(c).
    (b) Special considerations. Chickens and turkeys that have survived 
fowl cholera outbreaks should not be kept for replacements or breeders.
    (c) Related tolerances. See Sec.  556.640 of this chapter.
    (d) Conditions of use. The oral solution is administered as a cattle 
drench or diluted as directed to prepare drinking water. The powder is 
used to prepare a drench or drinking water. The concentrations and uses 
of the various solutions are as follows:
    (1) Broiler and replacement chickens only. (i) Amount. 1.875 (0.05 
percent) grams per gallon.
    (ii) Indications for use. Treatment of disease outbreaks of 
coccidiosis, fowl cholera, and infectious coryza.
    (iii) Limitations. Administer for 6 consecutive days; do not 
administer to chickens over 16 weeks of age; as sole source of drinking 
water and sulfonamide medication; as sulfadimethoxine solution or 
sulfadimethoxine soluble sodium salt; withdraw 5 days before slaughter.
    (2) Meat-producing turkeys only--(i) Amount. 0.938 (0.025 percent) 
grams per gallon.
    (ii) Indications for use. Treatment of disease outbreaks of 
coccidiosis and fowl cholera.
    (iii) Limitations. Administer for 6 consecutive days; do not 
administer to turkeys over 24 weeks of age; as sole source of drinking 
water and sulfonamide medication; as sulfadimethoxine solution or 
sulfadimethoxine soluble sodium salt; withdraw 5 days before slaughter.
    (3) Dairy calves, dairy heifers, and beef cattle only--(i) Amount. 
1.18 to 2.36 (0.031 to 0.062 percent) grams per gallon.
    (ii) Indications for use. Treatment of shipping fever complex, 
bacterial pneumonia, calf diphtheria, and foot rot.
    (iii) 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; in drinking water or drench; available as a 
sulfadimethoxine soluble powder or a 12.5 percent sulfadimethoxine 
sodium solution (3.75 grams sulfadimethoxine per fluid ounce); if no 
improvement within 2 to 3 days, reevaluate diagnosis; do not treat

[[Page 190]]

beyond 5 days; withdraw 7 days before slaughter.

[40 FR 13838, Mar. 27, 1975, as amended at 58 FR 6092, Jan. 26, 1993; 59 
FR 56000, Nov. 10, 1994; 61 FR 4875, Feb. 9, 1996; 62 FR 8371, Feb. 25, 
1997; 62 FR 23357, Apr. 30, 1997; 62 FR 35076, June 30, 1997; 62 FR 
40932, July 31, 1997; 63 FR 59714, Nov. 5, 1998; 64 FR 18572, Apr. 15, 
1999]



Sec.  520.2220b  Sulfadimethoxine tablets and boluses.

    (a) Sponsors. Approval to firms identified in Sec.  510.600(c) of 
this chapter as follows:
    (1) To 000069, approval for use as in paragraphs (d)(1), (d)(2), and 
(d)(3) of this section.
    (2) To 000061, approval for use as in paragraph (d)(2).
    (b) Related tolerances. See Sec.  556.640 of this chapter.
    (c) [Reserved]
    (d) It is used as follows:
    (1) Cattle--(i) Amount. 1.25 to 2.5 grams per 100 pounds body 
weight.
    (ii) Indications for use. Treatment of foot rot, bacterial 
pneumonia, shipping fever, and calf diphtheria.
    (iii) Limitations. 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 from 4 to 5 days; 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.
    (2) Dogs and cats. (i) Amount. 12.5 to 25 milligrams per pound of 
body weight.
    (ii) Indications for use. Treatment of sulfadimethoxine-susceptible 
bacterial infections.
    (iii) Limitations. Administer 25 milligrams per pound of body weight 
on the first day followed by 12.5 milligrams per pound of body weight 
per day until the animal is free of symptoms for 48 hours. Federal law 
restricts this drug to use by or on the order of a licensed 
veterinarian.
    (3) Beef cattle and nonlactating dairy cattle--(i) Amount. 12.5-
gram-sustained-release bolus.
    (ii) Indications for use. Treatment of shipping fever complex and 
bacterial pneumonia associated with organisms such as Pasteurella spp. 
sensitive to sulfadimethoxine; calf diphtheria and foot rot associated 
with Sphaerophorus necrophorus sensitive to sulfadimethoxine.
    (iii) Limitations. Administer one 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. Do not use in lactating dairy cattle. Do 
not administer within 12 days of slaughter. During treatment make 
certain that animals maintain adequate water intake. 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 40 FR 43488, Sept. 22, 1975; 
49 FR 36830, Sept. 20, 1984; 59 FR 56000, Nov. 10, 1994; 61 FR 4875, 
Feb. 9, 1996; 62 FR 61625, Nov. 19, 1997; 64 FR 15684, Apr. 1, 1999]



Sec.  520.2220c  Sulfadimethoxine oral suspension.

    (a) Chemical name. N'-(2,6-Dimethoxy-4-pyrimidinyl) sulfanilamide.
    (b) Specifications. Each milliliter of the drug contains 50 
milligrams of sulfadimethoxine.
    (c) Sponsor. See Nos. 000061 and 000069 in Sec.  510.600(c) of this 
chapter.
    (1) It is intended for use in the treatment of sulfonamide 
susceptible bacterial infections in dogs and cats and enteritis 
associated with coccidiosis in dogs.
    (2) On the first day of treatment administer an oral dose of 25 
milligrams per pound of body weight, then follow with a daily dosage of 
12.5 milligrams per pound of body weight. Length of treatment will 
depend upon clinical response. Continue treatment until patient is 
asymptomatic for 48 hours. Maintain adequate water intake during the 
treatment period.
    (3) For use only by or on the order of a licensed veterinarian.

[40 FR 13838, Mar. 27, 1975, as amended at 59 FR 56000, Nov. 10, 1994; 
61 FR 4875, Feb. 9, 1996; 62 FR 61625, Nov. 19, 1997]



Sec.  520.2220d  Sulfadimethoxine-ormetoprim tablets.

    (a) Specifications. Each tablet contains 120 milligrams (100 
milligrams of sulfadimethoxine and 20 milligrams of ormetoprim), 240 
milligrams (200 milligrams of sulfadimethoxine and 40 milligrams of 
ormetoprim), 600 milligrams (500 milligrams of sulfadimethoxine and 100 
milligrams of ormetoprim), or

[[Page 191]]

1200 milligrams (1,000 milligrams of sulfadimethoxine and 200 milligrams 
of ormetoprim).
    (b) Sponsor. See No. 000069 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use--(1) Amount. On the first day of treatment, 
administer 25 milligrams per pound (55 milligrams per kilogram) of body 
weight. Then follow with a daily dosage of 12.5 milligrams per pound 
(27.5 milligrams per kilogram) of body weight.
    (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 
Escherichia coli, Staphlococcus spp., and Proteus mirabilus susceptible 
to ormetoprim-potentiated sulfadimethoxine.
    (3) Limitations. Continue treatment until patient is asymptomatic 
for 48 hours, but do not exceed a total of 21 consecutive days. Maintain 
adequate water intake during the treatment period. Safety in breeding 
animals has not been established. Federal law restricts this drug to use 
by or on the order of a licensed veterinarian.

[54 FR 48593, Nov. 24, 1989, as amended at 59 FR 56000, Nov. 10, 1994; 
61 FR 4875, Feb. 9, 1996; 61 FR 46719, Sept. 5, 1996]



Sec.  520.2240  Sulfaethoxypyridazine.



Sec.  520.2240a  Sulfaethoxypyridazine drinking water.

    (a) Chemical name. N'-(6-Ethoxy-3-pyridazinyl) sulfanilamide.
    (b) Specifications. Melting point range of 180 [deg]C. to 186 
[deg]C.
    (c) Sponsor. See No. 053501 in Sec.  510.600(c) of this chapter.
    (d) Related tolerances. See Sec.  556.650 of this chapter.
    (e) Conditions of use. It is used as follows:
    (1) Swine--(i) Amount. 1.9 to 3.8 grams per gallon (0.05 percent to 
0.1 percent).
    (ii) Indications for use. Treatment of bacterial scours pneumonia 
enteritis, bronchitis, septicemia accompanying Salmonella cholerasuis 
infection.
    (iii) Limitations. 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 as sodium sulfaethoxypyridazine; do not treat within 10 days of 
slaughter; as sole source of sulfonamide; for use by or on the order of 
a licensed veterinarian.
    (2) Cattle--(i) Amount. 2.5 grams per gallon (0.066 percent).
    (ii) Indications for use. Treatment of respiratory infections 
(pneumonia, shipping fever), foot rot, calf scours; as adjunctive 
therapy in septicemia accompanying mastitis and metritis.
    (iii) Limitations. Administer at the rate of 1 gallon per 100 pounds 
of body weight per day for 4 days; as sodium sulfaethoxypyridazine; do 
not treat within 16 days of slaughter; as sole source of sulfonamide; 
for use by or on the order of a licensed veterinarian; milk that has 
been taken from animals during treatment and for 72 hours (6 milkings) 
after latest treatment must not be used for food.

[40 FR 13838, Mar. 27, 1975, as amended at 67 FR 78355, Dec. 24, 2002]



Sec.  520.2240b  Sulfaethoxypyridazine tablets.

    (a) Chemical name. N'-(6-Ethoxy-3-pyridazinyl) sulfanilamide.
    (b) Specifications. Melting point range of 180 [deg]C to 186 [deg]C.
    (c) Sponsor. See No. 053501 in Sec.  510.600(c) of this chapter.
    (d) Related tolerances. See Sec.  556.650 of this chapter.
    (e) Conditions of use. It is used for cattle as follows:
    (1) Amount. 2.5 or 15 grams per tablet.
    (i) Indications for use. Treatment of respiratory infections 
(pneumonia, shipping fever), foot rot, calf scours; as adjunctive 
therapy in septicemia accompanying mastitis and metritis.
    (ii) Limitations. Administer 25 milligrams per pound of animal 
weight per day for 4 days; do not treat within 16 days of slaughter; as 
sole source of sulfonamide; 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; for use only by or on the order of a licensed 
veterinarian.
    (2) Amount. 15-gram controlled release tablets.
    (i) Indications for use. Treatment of foot rot and respiratory 
infections (shipping fever and pneumonia) caused by sulfonamide-
susceptible pathogens (E. coli, streptococci, staphylococci,

[[Page 192]]

Sphaerophorus necrophorus and Gram-negative rods including Pasteurella); 
for use prophylactically in cattle during periods of stress for reducing 
losses due to sulfonamide sensitive disease conditions.
    (ii) Limitations. Administer 100 milligrams per pound of body 
weight; do not treat within 16 days of slaughter; as sole source of 
sulfonamide; not for use in lactating dairy cows; 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 67 FR 78355, Dec. 24, 2002]



Sec.  520.2260  Sulfamethazine oral dosage forms.



Sec.  520.2260a  Sulfamethazine oblet, tablet, and bolus.

    (a)(1) Sponsor. See No. 053501 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. Not for use 
in lactating dairy animals. Do not treat cattle within 10 days of 
slaughter. Not to be used in horses intended for food.
    (b)(1) Sponsor. See No. 053501 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.
    (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]



Sec.  520.2260b  Sulfamethazine sustained-release boluses.

    (a)(1) Sponsor. See No. 000859 in Sec.  510.600(c) of this chapter 
for use of a

[[Page 193]]

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.
    (b)(1) Sponsor. See No. 053501 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.
    (c)(1) Sponsor. See No. 061623 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.\1\
---------------------------------------------------------------------------

    \1\ These conditions are NAS/NRC reviewed and found effective. 
Applications for these uses need not inlcude effectiveness data as 
specified by Sec.  514.111 of this chapter, but may require 
bioequivalency and safety information.
---------------------------------------------------------------------------

    (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.)\1\
    (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 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 lactating dairy cattle. Do not treat animals 
within 12 days of slaughter.
    (d)(1) Sponsor. See 000859 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

[[Page 194]]

(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 diary cattle; if treated 
animals do not respond within 2 to 3 days, consult a veterinarian.
    (e)(1) Sponsor. See No. 061623 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.
    (f)(1) Sponsor. See No. 000010 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.
    (g) Related tolerances. See Sec.  556.670 of this chapter.
    (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.
    (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

[[Page 195]]

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]



Sec.  520.2260c  Sulfamethazine sustained-release tablets.

    (a) Sponsor. See No. 053501 in Sec.  510.600(c) of this chapter for 
use of an 8-gram sulfamethazine sustained-release tablet.
    (b) 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. If there is no response within 2 to 3 days, 
reevaluate therapy. Do not crush tablets. 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]



Sec.  520.2261  Sulfamethazine sodium oral dosage forms.



Sec.  520.2261a  Sulfamethazine sodium drinking water solution.

    (a) Sponsors. See Nos. 017800 and 053501 in Sec.  510.600(c) of this 
chapter for use of a 12.5-percent sulfamethazine sodium solution.
    (b) Related tolerances in edible products. See Sec.  556.670 of this 
chapter.
    (c) 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 (Haemophilus gallinarum), 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. Not 
for use in lactating dairy cattle. 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

[[Page 196]]

turkeys must actually consume enough medicated water which provides the 
recommended dosages.
    (d) NAS/NRC status. The conditions of use specified in this section 
have been reviewed by NAS/NRC and are found effective. Applications for 
these uses need not include effectiveness data as specified by Sec.  
514.111 of this chapter, but may require bioequivalency and safety 
information.

[47 FR 25322, June 11, 1982, as amended at 47 FR 25735, June 15, 1982; 
67 FR 78355, Dec. 24, 2002]



Sec.  520.2261b  Sulfamethazine sodium soluble powder.

    (a) Sponsor. See No. 053501 in Sec.  510.600(c) of this chapter for 
use of a soluble powder composed of 100 percent sulfamethazine sodium.
    (b) Related tolerances in edible products. See Sec.  556.670 of this 
chapter.
    (c) Conditions of use--(1) Amount. Administer in drinking water to 
provide: Chickens 58 to 85 milligrams of sulfamethazine sodium per pound 
of body weight per day; turkeys 50 to 124 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. Administer to cattle and swine in drinking water, or as a 
drench, to provide 108 milligrams of sulfamethazine sodium per pound of 
body weight on the first day and 54 milligrams of sulfamethazine sodium 
per pound of body weight per day on the second, third, and fourth days 
of administration.
    (2) Indications for use. For treatment and control of disease 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 (Haemophilus gallinarum), 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 for 2 days, then reduce drug concentration 
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 prior to slaughter for food. Not 
for use in lactating dairy animals. 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.
    (d) NAS/NRC status. The conditions of use specified in this section 
have been reviewed by NAS/NRC and are found effective. Applications for 
these uses need not include effectiveness data as specified by Sec.  
514.111 of this chapter, but may require bioequivalency and safety 
information.

[47 FR 25322, June 11, 1982, as amended at 67 FR 78355, Dec. 24, 2002]



Sec.  520.2280  Sulfamethizole and methenamine mandelate tablets.

    (a) Specifications. Each tablet contains 250 milligrams of 
sulfamethizole and 250 milligrams of methenamine mandelate.
    (b) Sponsor. See No. 000856 in Sec.  510.600(c) of this chapter.

[[Page 197]]

    (c) Conditions of use. (1) The drug is indicated for the treatment 
of urinary tract infections in dogs and cats such as cystitis, 
nephritis, prostatitis, urethritis, and pyelonephritis. It is also used 
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.
    (2) It is administered at a dosage level of one tablet for each 20 
pounds of body weight given three times per day. The drug should be 
given until all signs are alleviated. To reduce the possibility of a 
relapse, it is suggested that therapy be continued for a further period 
of a week to 10 days.
    (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 50 FR 13561, Apr. 5, 1985]



Sec.  520.2320  Sulfanitran and aklomide in combination.

    (a) Chemical names. (1) Sulfanitran: Acetyl-(p-nitrophenyl)-
sulfanilamide.
    (2) Aklomide: 2-Chloro-4-nitrobenzamide.
    (b) Specifications. (1) Sulfanitran conforms to the following 
specifications:
    (i) Melting point range: 260 [deg]C. to 261 [deg]C.
    (ii) Assay (by sodium nitrite titration): 97 to 100.5 percent.
    (iii) Moisture (Method No. 6.123, ``Toluene Distillation Method--
Official Final Action'' in ``Official Methods of Analysis of the 
Association of Official Analytical Chemists,'' 13th Ed., 1980, p. 83. 
Copies are available from the Association of Official Analytical 
Chemists, 2200 Wilson Blvd., Suite 400, Arlington, VA 22201-3301, or 
available for inspection at the Office of the Federal Register, 800 
North Capitol Street, NW., suite 700, Washington, DC 20001): Not more 
than 2.0 percent.
    (iv) Molecular weight: 335.34.
    (v) Soluble in 0.1N sodium hydroxide, reprecipitating unchanged on 
acidification.
    (2) Aklomide conforms to the following specifications:
    (i) Minimum melting point: 170 [deg]C.
    (ii) Moisture content: Not to exceed 1.0 percent.
    (iii) Purity: Not less than 98 percent on an anhydrous basis.
    (c) Sponsor. See No. 053501 in Sec.  510.600(c) of this chapter.
    (d) Related tolerances. See Sec. Sec.  556.30 and 556.680 of this 
chapter.
    (e) Conditions of use. It is used in the drinking water of chickens 
as follows:
    (1) Amount. 374-747 milligrams of sulfanitran with 477-954 
milligrams of aklomide.
    (2) Indications for use. As an aid in the treatment of coccidiosis 
caused by E. tenella, E. necatrix, and E. acervulina.
    (3) Limitations. Administer for 2 days at 747 milligrams of 
sulfanitran per gallon and 954 milligrams of aklomide per gallon, 
followed by 5 days at 374 milligrams of sulfanitran per gallon and 477 
milligrams of aklomide per gallon; do not treat birds over 6 weeks of 
age; do not administer within 5 days of slaughter; not for laying 
chickens.

[40 FR 13838, Mar. 27, 1975, as amended at 47 FR 9396, Mar. 5, 1982; 54 
FR 18280, Apr. 28, 1989; 55 FR 8460, Mar. 8, 1990]



Sec.  520.2325  Sulfaquinoxaline oral dosage forms.



Sec.  520.2325a  Sulfaquinoxaline drinking water.

    (a) Sponsor. See Sec.  510.600(c) of this chapter for identification 
of the sponsors.
    (1) To No. 050749 for use of a 25-percent sulfaquinoxaline soluble 
powder and a 20-percent sulfaquinoxaline sodium solution as provided for 
in paragraph (c) of this section.
    (2) To No. 060594 for use of 3.44- and 12.85-percent 
sulfaquinoxaline sodium solutions as provided for in paragraphs (c)(1), 
(c)(2), (c)(3), (c)(4)(i), and (c)(4)(ii) of this section.
    (3) To No. 046573 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.
    (4) No. 053501 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.

[[Page 198]]

    (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. Consult a veterinarian or poultry pathologist for 
diagnosis. 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.

[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]



Sec.  520.2325b  Sulfaquinoxaline drench.

    (a)-(b) [Reserved]
    (c) Sponsor. See No. 050749 in Sec.  510.600(c) of this chapter.
    (d) NAS/NRC status. The conditions of use specified in this section 
have been reviewed by NAS/NRC and are found effective. Applications for 
these uses need not include effectiveness data as specified by Sec.  
514.111 of this chapter, but may require bioequivalency information. 
Applications must be accompanied by a written commitment to undertake 
the human safety studies required by FDA.
    (e) Conditions of uses. As a 25-percent sulfaquinoxaline soluble 
powder.
    (1) For the control and treatment of outbreaks of coccidiosis in 
cattle and calves caused by Eimeria bovis or E. zurnii.
    (2) Give one teaspoon of 25 percent sulfaquinoxaline soluble powder 
for each 125 pounds of body weight for 3 to 5 days as a drench.
    (f) Limitations. For control of outbreaks of disease, medication 
should be

[[Page 199]]

initiated as soon as the diagnosis is determined. Consult a veterinarian 
for diagnosis. Do not give to cattle within 10 days of slaughter for 
food. Not for use in lactating dairy cattle.

[48 FR 3964, Jan. 28, 1983, as amended at 55 FR 29843, July 23, 1990; 59 
FR 33197, June 28, 1994]



Sec.  520.2330  Sulfisoxazole tablets.

    (a) Specifications. Each tablet contains 260 milligrams (4 grains) 
of sulfisoxazole.
    (b) Sponsor. See No. 000856 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use--(1) Amount. Administer one tablet orally per 
4 pounds of body weight. \1\
---------------------------------------------------------------------------

    \1\ These conditions are NAS/NRC reviewed and deemed effective. 
Applications for these uses need not include effectiveness data as 
specified by Sec.  514.111 of this chapter, but may require 
bioequivalency and safety information.
---------------------------------------------------------------------------

    (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. \1\
    (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. \1\

[43 FR 60895, Dec. 29, 1978]



Sec.  520.2345  Tetracycline oral dosage forms.



Sec.  520.2345a  Tetracycline hydrochloride capsules.

    (a) Specifications. Each capsule contains 50, 100, 125, 250, or 500 
milligrams of tetracycline hydrochloride.
    (b) Sponsor. See Sec.  510.600(c) of this chapter for identification 
of the sponsors:
    (1) To No. 000009: 250 milligrams per capsule.
    (2) To No. 000069: 125, 250, and 500 milligrams per capsule.
    (3) To No. 000115: 50, 100, 250, and 500 milligrams per capsule.
    (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 the 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 59 FR 59365, Nov. 17, 1994; 
63 FR 5255, Feb. 2, 1998]



Sec.  520.2345b  Tetracycline tablets.

    (a) Specifications. Each tablet contains 100, 250, or 500 milligrams 
of tetracycline (as the hydrochloride).
    (b) Sponsor. For 100, 250, or 500 milligrams per tablet, see No. 
000069 in Sec.  510.600(c) of this chapter. For 250 milligrams per 
tablet, see No. 000009 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]



Sec.  520.2345c  Tetracycline boluses.

    (a) Specifications. Each bolus contains 500 milligrams of 
tetracycline (as the hydrochloride).

[[Page 200]]

    (b) Sponsors. See No. 053501 in Sec.  510.600(c) of this chapter for 
use as in paragraph (d)(1) of this section. See No. 000009 in Sec.  
510.600(c) of this chapter for use as in paragraph (d)(2) of this 
section.
    (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.
    (iii) National Academy of Sciences/National Research Council (NAS/
NRC) status. The conditions of use specified in paragraph (d)(1)(i) of 
this section were NAS/NRC reviewed and found effective. Applications for 
these uses need not include effectiveness data as specified in Sec.  
514.111 of this chapter, but may require bioequivalency and safety 
information.
    (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]



Sec.  520.2345d  Tetracycline hydrochloride soluble powder.

    (a) Sponsors. The following sponsors listed in Sec.  510.600(c) of 
this chapter hold approvals for the drug concentrations (i.e., grams of 
tetracycline hydrochloride per pound) and conditions of use indicated:
    (1) 000010, 046573, 051259, 057561, and 059130 102.4 and 324 grams 
per pound as in paragraph (d) of this section.
    (2) 000069, 25 grams per pound as in paragraphs (d)(3) and (d)(4) of 
this section.
    (3) 053501, 102.4 and 324 grams per pound as in paragraphs (d)(1) 
and (d)(2) of this section.
    (4) 046573, 102.4 and 324 grams per pound as in paragraph (d)(3) of 
this section.
    (b) Related tolerances. See Sec.  556.720 of this chapter.
    (c) [Reserved]
    (d) Conditions of use in drinking water--(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 (Hemophilus 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 sponsor 053501 and 
within 5 days of treatment for sponsors 046573 and 000010; prepare a 
fresh solution daily; use as the sole source of tetracycline.
    (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 (Hemophilus 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 sponsor 053501 and 
within 4 days of treatment for sponsors 046573 and 000010; prepare a 
fresh solution daily; use as the sole source of tetracycline.
    (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.

[[Page 201]]

    (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.
    (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.

[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]



Sec.  520.2345e  Tetracycline oral liquid.

    (a) Specifications. Each milliliter contains the equivalent of 
either 25 or 100 milligrams of tetracycline hydrochloride.
    (b) Sponsor. See No. 000069, in Sec.  510.600(c) of this chapter for 
use of 25 or 100 milligrams per milliliter liquid in dogs as in 
paragraph (c)(1) of this section; see No. 000009 in Sec.  510.600(c) of 
this chapter for use of 100 milligrams per milliliter liquid in dogs and 
cats as in paragraph (c)(2).
    (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.
    (iv) National Academy of Sciences/National Research Council (NAS/
NRC) status. These conditions were NAS/NRC reviewed and found effective. 
Applications for these uses need not include effectiveness data as 
specified by Sec.  514.111 of this chapter, but may require 
bioequivalency and safety information.
    (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]



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. 000009 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use. 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. Continue treatment for at least 48 hours after the 
temperature has returned to normal and all evidence of infection has 
disappeared. As with all antibiotics, appropriate in vitro culturing and 
susceptibility tests of samples taken before treatment

[[Page 202]]

should be conducted. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[57 FR 37329, Aug. 18, 1992]



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. No. 000009 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use. 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. Continue treatment for at least 48 hours after the 
temperature has returned to normal and all evidence of infection has 
disappeared. As with all antibiotics, appropriate in vitro culturing and 
susceptibility tests of samples taken before treatment should be 
conducted. Federal law restricts this drug to use by or on the order of 
a licensed veterinarian.

[57 FR 37329, Aug. 18, 1992]



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. 000009 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use. 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. As with all antibiotics, appropriate in vitro 
culturing and susceptibility tests of samples taken before treatment 
should be conducted. Administer for 48 hours only. Continue treatment if 
needed with tetracycline/novobiocin alone. The product is 
contraindicated in animals with tuberculosis, hyperadrenocorticalism, or 
peptic ulcers. Clinical and experimental data have 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. 
Federal law restricts this drug to use by or on the order of a licensed 
veterinarian.

[57 FR 37329, Aug. 18, 1992]



Sec.  520.2362  Thenium closylate tablets.

    (a) Chemical name. (N,N-Dimethyl-N-2-phenoxyethyl-N-2'-thenylammo-
nium)-p-chlorobenzene-sulfonate.
    (b) Specifications. Thenium closylate tablets contain thenium 
closylate equivalent to 500 milligrams thenium as base in each tablet.
    (c) Sponsor. See No. 000061 in Sec.  510.600(c) of this chapter.
    (d) Conditions of use. (1) The tablets are administered orally to 
dogs as a single day treatment of canine ancylostomiasis by the removal 
from the intestines of the adult forms of the species Ancylostoma 
caninum and Uncinaria stenocephala (hookworms). Dogs weighing 10 pounds 
and over are administered 1 tablet as a single dose. Dogs

[[Page 203]]

weighing 5 to 10 pounds are administered one-half tablet twice during a 
single day. All dosages are given for 1 day only. The treatment should 
be repeated after 2 or 3 weeks.
    (2) Suckling puppies or recently weaned puppies weighing less than 5 
pounds should not be treated with the drug. Animals that are severely 
infected, exhibiting evidence of intestinal hemorrhage, debilitation, 
and anemia, should be given supportive treatment.
    (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 41 FR 53477, Dec. 7, 1976; 46 
FR 48642, Oct. 2, 1981; 61 FR 8873, Mar. 6, 1996; 62 FR 61625, Nov. 19, 
1997]



Sec.  520.2380  Thiabendazole oral dosage forms.



Sec.  520.2380a  Thiabendazole top dressing and mineral protein feed block.

    (a) Chemical name. 2-(4-Thiazolyl)-benzimidazole.
    (b) Specifications. Conforms to N.F. XII.
    (c) Sponsor. (1) See No. 017800 in Sec.  510.600(c) of this chapter 
for the sponsor of the usage provided by paragraph (e)(1)(ii) of this 
section.
    (2) See No. 050604 in Sec.  510.600(c) of this chapter for the 
sponsor of the usages provided for by paragraph (e)(1)(ii) of this 
section.
    (3) See No. 021930 in Sec.  510.600(c) of this chapter for the 
sponsor of the usage provided for by paragraph (e)(2) of this section.
    (d) Related tolerances. See Sec.  556.730 of this chapter.
    (e) Conditions of use. It is used as follows:
    (1) Horses--(i) Route of administration. In feed, as a top dressing.
    (a) Amount. 2 grams per 100 pounds of body weight.
    (b) Indications for use. For control of large strongyles, small 
strongyles, pinworms, and threadworms (including members of the genera 
Strongylus, Cyathostomum, Cylicobrachytus, and related genera, 
Craterostomum, Oesophagodontus, Poteriostomum, Oxyuris, and 
Strongyloides).
    (c) Limitations. Add to the usual feed of horses mixed into that 
amount of the feed normally consumed at one feeding. Warning: Not for 
use in horses intended for food.
    (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]

[[Page 204]]



Sec.  520.2380b  Thiabendazole drench or oral paste.

    (a) Chemical name. 2-(4-Thiazolyl) benzimidazole.
    (b) Specifications. Conforms to N.F. XII.
    (c) Sponsor. See No. 050604 in Sec.  510.600(c) of this chapter for 
the sponsor of the usages provided for by paragraph (e) of this section.
    (d) Related tolerances. See Sec.  556.730 of this chapter.
    (e) 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. 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

[[Page 205]]

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) 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]



Sec.  520.2380c  Thiabendazole bolus.

    (a) Chemical name. 2-(4-Thiazolyl) benzimidazole.
    (b) Specifications. Conforms to N.F. XII.
    (c) Sponsor. See No. 050604 in Sec.  510.600(c) of this chapter.
    (d) Related tolerances. See Sec.  556.730 of this chapter.
    (e) 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.,

[[Page 206]]

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]



Sec.  520.2380d  Thiabendazole, piperazine citrate suspension.

    (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. 050604 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use. (1) It is administered to horses by stomach 
tube or as a drench at the rate of 1 fluid ounce of suspension per 100 
pounds of body weight 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 spp., Poteriostomum 
spp., Oxyuris spp., Strongyloides spp., and Parascaris spp.).
    (2) Do not use in horses intended to be used for food purposes.
    (3) For 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]



Sec.  520.2380e  Thiabendazole with trichlorfon.

    (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. (1) Used 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.) in horses.
    (2) 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.
    (3) Do not re-treat more than once every 30 days, preferably every 6 
to 8 weeks.
    (4) Do not treat animals if sick or debilitated; less than 4 months 
of age; or mares in last month of pregnancy.
    (5) Do not administer intravenous anesthetics, especially muscle 
relaxants, within 2 weeks of use.
    (6) Not for animals intended for food use.
    (7) Do not use within a few days before or after treatment with or 
exposure to cholinesterase-inhibiting drugs, pesticides, or chemicals.
    (8) If the label bears directions for administration of the drug 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.

[40 FR 23071, May 28, 1975, as amended at 48 FR 48229, Oct. 18, 1983]



Sec.  520.2380f  Thiabendazole, piperazine phosphate powder.

    (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. 050604 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use--(1) Amount. 2 grams of thiabendazole and 2.5 
grams of piperazine (0.3 ounce of powder) per 100 pounds of body weight.
    (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. 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. Not for animals

[[Page 207]]

intended for food use. 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 diagonosis, 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]



Sec.  520.2455  Tiamulin soluble powder.

    (a) Specifications. A water-soluble powder containing 45 percent 
tiamulin used to make a medicated drinking water containing 227 or 677 
milligrams of tiamulin per gallon.
    (b) Sponsor. See No. 000010 in Sec.  510.600(c) of this chapter.
    (c) Related tolerances. See Sec.  556.738 of this chapter.
    (d) Conditions of use in swine--(1) Amount. 3.5 milligrams of 
tiamulin per pound of body weight for 5 days.
    (i) Indications for use. For treatment of swine dysentery associated 
with Treponema hyodysenteriae susceptible to tiamulin.
    (ii) Limitations. Use for 5 consecutive days. Withdraw 3 days before 
slaughter. Prepare fresh water daily. Not for use in swine over 250 
pounds body weight. Use as only source of drinking water.
    (2) Amount. 10.5 milligrams of tiamulin per pound of body weight for 
5 days.
    (i) Indications for use. For treatment of swine pneumonia due to 
Actinobacillus pleuropneumoniae susceptible to tiamulin.
    (ii) Limitations. Use for 5 consecutive days. Withdraw 7 days before 
slaughter. Prepare fresh water daily. Not for use in swine over 250 
pounds body weight. Use as only source of drinking water. Do not allow 
consumption of feeds containing polyether ionophores (e.g., monensin, 
lasalocid, narasin or salinomycin) as adverse reactions may occur.

[52 FR 15718, Apr. 30, 1987, as amended at 58 FR 14313, Mar. 17, 1993; 
62 FR 35076, June 30, 1997]



Sec.  520.2456  Tiamulin liquid concentrate.

    (a) Specifications. A liquid concentrate containing 12.3 percent 
tiamulin used to make a medicated drinking water containing 227 
milligrams or 681 milligrams of tiamulin per gallon.
    (b) Sponsor. See 000010 in Sec.  510.600(c) of this chapter.
    (c) Related tolerances. See Sec.  556.738 of this chapter.
    (d) Conditions of use in swine-- (1) Amount. Dysentery: 3.5 
milligrams of tiamulin per pound of body weight daily. Pneumonia: 10.5 
milligrams of tiamulin per pound of body weight daily.
    (2) Indications for use. For treatment of swine dysentery associated 
with Treponema hyodysenteriae and swine pneumonia due to Actinobacillus 
pleuropneumoniae susceptible to tiamulin.
    (3) Limitations. Use for 5 consecutive days. When a dose is 3.5 
milligrams per pound of body weight daily, withdraw medication 3 days 
before slaughter. When a dose is 10.5 milligrams per pound of body 
weight daily, withdraw 7 days before slaughter. Prepare fresh medicated 
water daily. Not for use in swine over 250 pounds body weight. Use as 
only source of drinking water. Do not allow consumption of feeds 
containing polyether ionophores (e.g., monensin, lasalocid, narasin, or 
salinomycin) as adverse reactions may occur.

[58 FR 14313, Mar. 17, 1993, as amended at 62 FR 35076, June 30, 1997]



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

[[Page 208]]

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.
    (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.  520.2481  Triamcinolone acetonide tablets.

    (a) Specifications. Each tablet contains either 0.5 milligram or 1.5 
milligrams of the drug.
    (b) Sponsor. See Nos. 000010 and 053501 in Sec.  510.600(c) of this 
chapter.
    (c) NAS/NRC status. The conditions of use specified in this section 
are NAS/NRC reviewed and found effective. Applications for these uses 
need not include effectiveness data as specified by Sec.  514.111 of 
this chapter, but may require bioequivalency and safety information.
    (d) Conditions of use. (1) The drug is indicated for use in dogs and 
cats for its anti-inflammatory activity.
    (2) An initial daily dosage of 0.05 milligram per pound of body 
weight is usually sufficient to control symptoms, although up to 0.1 
milligram per pound of body weight may be given daily if response to the 
smaller dose is inadequate. As soon as feasible, and in any case within 
2 weeks, dosage should be reduced gradually to maintenance levels of 
0.0125 to 0.025 milligram per pound of body weight per day. Therapy 
should be discontinued by a gradual reduction in dosage after the 
condition has been controlled for several days. Therapy may be initiated 
with a single dose of sterile triamcinolone acetonide suspension 
veterinary in which case the tablet dosage should be administered 
beginning 5 to 7 days after the injection or when symptoms reappear.
    (3) The labeling shall comply with the requirements of Sec.  510.410 
of this chapter.
    (4) 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 51 FR 26002, July 18, 1986; 
53 FR 40727, Oct. 18, 1988; 62 FR 35076, June 30, 1997]



Sec.  520.2482  Triamcinolone acetonide oral powder.

    (a) Specifications. Each 15 grams of triamcinolone acetonide oral 
powder contains 10 milligrams of triamcinolone acetonide.
    (b) Sponsor. See No. 053501 in Sec.  510.600(c) of this chapter.
    (c) NAS/NRC status. The conditions of use specified in this section 
are NAS/

[[Page 209]]

NRC reviewed and found effective. Applications for these uses need not 
include effectiveness data as specified by Sec.  514.111 of this 
chapter, but may require bioequivalency and safety information.
    (d) Conditions of use. (1) The drug is used as an anti-inflammatory 
agent for horses.
    (2) It is administered at a dosage of 0.005 to 0.01 milligram 
triamcinolone acetonide per pound of body weight twice daily, sprinkled 
(top-dressed) on a small portion of feed. Treatment may be initiated 
with a single dose of sterile triamcinolone acetonide suspension USP 
followed after 3 or 4 days with the use of triamcinolone acetonide oral 
powder.
    (3) The labeling shall comply with the requirements of Sec.  510.410 
of this chapter.
    (4) Not for use in horses intended for food.
    (5) Federal law restricts this drug to use by or on the order of a 
licensed veterinarian.

[41 FR 24884, June 21, 1976, as amended at 50 FR 41489, Oct. 11, 1985; 
51 FR 26002, July 18, 1986]



Sec.  520.2520  Trichlorfon oral dosage forms.



Sec.  520.2520b  Trichlorfon and atropine.

    (a) Chemical name. (1) For trichlorfon: O,O-Dimethyl 2,2,2-
trichloro-1-hydroxyethyl phosphonate.
    (2) For atropine: Atropine N.F.
    (b) Sponsor. See No. 000856 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use. (1) The drug is used for the treatment of 
Syphacia obvelata (pinworm) in laboratory mice.
    (2) It is administered in distilled water as sole source of drinking 
water continuously for 7 to 14 days at 1.67 grams of trichlorfon and 7.7 
milligrams of atropine per liter.
    (3) Prepare fresh solution every 3 days. Do not use simultaneously 
with other drugs, insecticides, pesticides, or chemicals having 
cholinesterase activity, nor within 7 days before or after treatment 
with any other cholinesterase inhibitor.
    (4) Restricted to use by or on the order of a licensed veterinarian.



Sec.  520.2520e  Trichlorfon boluses.

    (a) Specifications. Each bolus contains either 7.3, 10.9, 14.6, or 
18.2 g of trichlorfon.
    (b) Sponsor. See 000856 in Sec.  510.600(c) of this chapter.
    (c) Special considerations. Trichlorfon is a cholinesterase 
inhibitor. Do not use this product on animals simultaneously with, or 
within 2 weeks, before or after treatment with or exposure to, 
neuromuscular depolarizing agents (i.e., succinylcholine) or to 
cholinesterase-inhibiting drugs, pesticides, or chemicals.
    (d) NAS/NRC status. Use of this drug has been NAS/NRC reviewed and 
found effective. Applications for these uses need not include 
effectiveness data as specified by Sec.  514.111 of this chapter.
    (e) Conditions of use--(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 fast horses before or after treatment. 
Treatment of mares in late pregnancy is not recommended. Surgery or any 
severe stress should be avoided for at least 2 weeks before or after 
treatment. Do not administer to sick, toxic, or debilitated horses. Not 
to be used in horses intended for use as food. Federal law restricts 
this drug to use by or on the order of a licensed veterinarian.

[45 FR 48127, July 18, 1980]



Sec.  520.2520f  Trichlorfon granules.

    (a) Specifications. Each package contains either 18.2 or 36.4 g of 
trichlorfon.
    (b) Sponsor. See 000856 in Sec.  510.600(c) of this chapter.
    (c) Special considerations. Trichlorfon is a cholinesterase 
inhibitor. Do not use this product on animals simultaneously with, or 
within 2 weeks before or after treatment with or exposure to 
neuromuscular depolarizing agents (i.e., succinylcholine) or to 
cholinesterase-inhibiting drugs, pesticides, or chemicals.

[[Page 210]]

    (d) NAS/NRC status. Use of this drug has been NAS/NRC reviewed and 
found effective. Applications for these uses need not include 
effectiveness data as specified by Sec.  514.111 of this chapter.
    (e) Conditions of use--(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 fast horses before or after treatment. 
Treatment of mares in late pregnancy is not recommended. Surgery or any 
severe stress should be avoided for at least 2 weeks before or after 
treatment. Do not administer to sick, toxic, or debilitated horses. Not 
to be used in horses intended for use as food. Federal law restricts 
this drug to use by or on the order of a licensed veterinarian.

[45 FR 48128, July 18, 1980]



Sec.  520.2520g  Trichlorfon, phenothiazine, and piperazine dihydrochloride powder.

    (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. 000856 in Sec.  510.600(c) of this chapter.
    (c) Special considerations. Labeling shall bear the following 
statements: The drug is a cholinesterase inhibitor. Do not use this 
product in horses simultaneously with, or within 2 weeks before or after 
treatment with, or exposure to, neuromuscular depolarizing agents (e.g., 
succinylcholine) or to cholinesterase-inhibiting drugs, pesticides, or 
chemicals.
    (d) Conditions of use--(1) Amount. 18.2 milligrams of trichlorfon, 
12.5 milligrams of phenothiazine, and 40.0 milligrams of piperazine base 
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. Mix powder and vial contents together in warm water 
to form suspension. Administer by stomach tube. Do not fast horses 
before or after treatment. Treatment of mares in late pregnancy is not 
recommended. Surgery or any severe stress should be avoided for at least 
2 weeks before or after treatment. Do not administer to sick, toxic, or 
debilitated horses. Not to be used in horses intended for use as food. 
Federal law restricts this drug to use by or on the order of a licensed 
veterinarian.

[48 FR 2757, Jan. 21, 1983]



Sec.  520.2582  Triflupromazine hydrochloride tablets.

    (a) Specifications. Each tablet contains either 10 milligrams or 25 
milligrams of triflupromazine hydrochloride.
    (b) Sponsor. See No. 053501 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use. (1) The drug is used in dogs and cats 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.\1\
    (2) The drug is administered orally to dogs and cats at a dosage 
level of 1 to 2 milligrams per pound of body weight daily; an initial 
dosage at the 2-milligrams level is suggested followed by daily doses at 
the 1-milligram level. Frequently, the drug may be withdrawn after 4 to 
5 days, with drug effect continuing after withdrawal.\1\
    (3) Do not use in conjunction with organophosphates and/or procaine 
hydrochloride, because phenothiazines may potentiate the toxicity of 
organophosphates and the activity of procaine hydrochloride.\1\
    (4) Federal law restricts this drug to use by or on the order of a 
licensed veterinarian.\1\

[40 FR 13838, Mar. 27, 1975, as amended at 50 FR 41489, Oct. 11, 1985]

[[Page 211]]



Sec.  520.2604  Trimeprazine tartrate and prednisolone tablets.

    (a) Specifications. Each tablet contains: trimeprazine tartrate, 5 
milligrams; and prednisolone, 2 milligrams.
    (b) Sponsor. See No. 000069 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use. (1) The drug is administered orally to dogs 
for the relief of itching regardless of cause; 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. It is also used in dogs 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. The product may also be administered to 
dogs suffering from acute or chronic bacterial infections, provided the 
infection is controlled by appropriate antibiotic or chemotherapeutic 
agents.\1\
    (2) The drug is administered orally at an initial dosage level of 
\1/2\ tablet twice daily to dogs weighing up to 10 pounds, one tablet 
twice daily to dogs weighing 11 to 20 pounds, two tablets twice daily to 
dogs weighing 21 to 40 pounds, and three tablets twice daily to dogs 
weighing over 40 pounds. 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. Dosages in individual cases may vary 
and should be adjusted until proper response is obtained.\1\
    (3) Do not use the drug in cases of viral infections involving 
corneal ulceration or dendritic ulceration of the cornea.\1\
    (4) Clinical and experimental data have 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.\1\
    (5) Federal law restricts this drug to use by or on the order of a 
licensed veterinarian.\1\
---------------------------------------------------------------------------

    \1\ These conditions are NAS/NRC reviewed and deemed effective. 
Applications for these uses need not include effectiveness data as 
specified by Sec.  514.111 of this chapter, but may require 
bioequivalency and safety information.

[40 FR 13838, Mar. 27, 1975, as amended at 56 FR 50653, Oct. 8, 1991; 60 
FR 55659, Nov. 2, 1995]



Sec.  520.2605  Trimeprazine tartrate and prednisolone capsules.

    (a) Specifications. Each capsule contains 3.75 milligrams of 
trimeprazine in sustained released form (as the tartrate) and 1 
milligram of prednisolone (capsule no. 1) or 7.5 milligrams of 
trimeprazine in sustained release form (as the tartrate) and 2 
milligrams of prednisolone (capsule no. 2).
    (b) Sponsor. See 000069 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use--(1) Amount. Administer either capsule orally 
once daily to dogs as follows:

------------------------------------------------------------------------
                                                     Number of capsules
                                                          per dose
              Animal weight (pounds)               ---------------------
                                                     Capsule    Capsule
                                                      No. 1      No. 2
------------------------------------------------------------------------
Up to 10..........................................          1  .........
11 to 20..........................................          2          1
21 to 40..........................................          4          2
Over 40...........................................          6          3
------------------------------------------------------------------------

    (2) Indications for use. For the relief of itching regardless of 
cause, 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). It is 
also used in dogs as adjunctive therapy in various cough conditions 
including treatment of ``kennel cough'' or tracheobronchitis, bronchitis 
including allergic bronchitis, tonsillitis, acute upper respiratory 
infections, and coughs of nonspecific origin. The product may also be 
administered to dogs suffering from acute or chronic bacterial 
infections, provided the infection is controlled by appropriate 
antibiotic or chemotherapeutic agents.
    (3) Limitations. After 4 days, reduce dosage to one-half the initial 
dose or to

[[Page 212]]

an amount sufficient to maintain remission of symptoms. Dosages in 
individual cases may vary and should be adjusted until proper response 
is obtained. Do not use the drug in cases of viral infections involving 
corneal ulceration or dendritic ulceration of the cornea. Clinical and 
experimental data have 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. Federal law restricts this drug to use 
by or on the order of a licensed veterinarian.

[48 FR 19367, Apr. 29, 1983, as amended at 56 FR 50653, Oct. 8, 1991; 60 
FR 55659, Nov. 2, 1995]



Sec.  520.2610  Trimethoprim and sulfadiazine tablets.

    (a) Specifications. Each tablet contains 30 milligrams (5 milligrams 
of trimethoprim and 25 milligrams of sulfadiazine), 120 milligrams (20 
milligrams of trimethoprim and 100 milligrams of sulfadiazine), 480 
milligrams (80 milligrams of trimethoprim and 400 milligrams of 
sulfadiazine) or 960 milligrams (160 milligrams of trimethoprim and 800 
milligrams of sulfadiazine).
    (b) Sponsor. See Nos. 000061 and 000856 in Sec.  510.600(c) of this 
chapter.
    (c) Conditions of use. (1) 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.
    (2) The drug is given orally at 30 milligrams per kilogram of body 
weight per day (14 milligrams per pound per day), or as follows:

------------------------------------------------------------------------
                                                               Number of
                 Animal body weight (pounds)                    tablets
------------------------------------------------------------------------
                              30 mg tablets
 
------------------------------------------------------------------------
2.2.........................................................           1
4.4.........................................................           2
6.6.........................................................           3
8.8.........................................................           4
-------------------------------------------------------------
                             120 mg tablets
 
------------------------------------------------------------------------
Up to 9.....................................................           1
10 to 19....................................................           2
20 to 29....................................................           3
30 to 40....................................................           4
 
-------------------------------------------------------------
                             480 mg tablets
 
------------------------------------------------------------------------
30 to 40....................................................           1
40 to 60....................................................      1\1/2\
60 to 80....................................................           2
80 to 110...................................................           3
Over 110....................................................           4
------------------------------------------------------------------------

    (3) The drug is given once daily. Alternatively, especially in 
severe infections, the initial dose may be followed by one-half the 
recommended daily dose every 12 hours. If no improvement is seen in 3 
days, discontinue therapy and reevaluate diagnosis.
    (4) Administer for 2 to 3 days after symptoms have subsided. Do not 
treat for more than 14 consecutive days.
    (5) During long term treatment, periodic platelet counts and white 
and red blood cell counts are recommended.
    (6) The drug should not be used in patients showing marked liver 
parenchymal damage or blood dyscrasia, nor in those with a history of 
sulfonamide sensitivity.
    (7) Federal law restricts this drug to use by or on the order of a 
licensed veterinarian.

[41 FR 3853, Jan. 27, 1976, as amended at 44 FR 32214, June 5, 1979; 46 
FR 23231, Apr. 24, 1981; 47 FR 36814, Aug. 24, 1982; 50 FR 9800, Mar. 
12, 1985; 50 FR 11852, Mar. 26, 1985; 61 FR 5506, Feb. 13, 1996; 61 FR 
8873, Mar. 6, 1996; 62 FR 61625, Nov. 19, 1997]



Sec.  520.2611  Trimethoprim and sulfadiazine oral paste.

    (a) Specifications. Each gram of oral paste contains 400 milligrams 
(67 milligrams of trimethoprim and 333 milligrams of sulfadiazine).
    (b) Sponsor. See No. 000856 in Sec.  510.600(c) of this chapter for 
product to be dosed at 5 grams per 150 pounds of body weight per day. 
See No. 000061 in Sec.  510.600(c) of this chapter for product to be 
dosed at 3.75 grams per 110 pounds of body weight per day.

[[Page 213]]

    (c) Conditions of use--(1) Dosage. (i) 5 grams (335 milligrams of 
trimethoprim and 1,665 milligrams of sulfadiazine) per 150 pounds (68 
kilograms) of body weight per day. (ii) 3.75 grams (250 milligrams of 
trimethoprim and 1,250 milligrams of sulfadiazine) per 110 pounds (50 
kilograms) of body weight per day.
    (2) Indications for use. For horses where systemic anti-bacterial 
action against sensitive organisms is required during treatment of acute 
strangles, respiratory infections, acute urogenital infections, and 
wound infections and abscesses.
    (3) Limitations. Administer orally, once a day, as a single dose for 
5 to 7 days; daily dose may also be halved and given morning and 
evening; for acute infection therapy continue treatment 2 to 3 days 
after clinical signs have subsided; if no improvement of acute 
infections is seen in 3 to 5 days, reevaluate diagnosis; a complete 
blood count should be done periodically for prolonged use; not for use 
in horses intended for food; Federal law restricts this drug to use by 
or on the order of a licensed veterinarian.

[48 FR 34469, July 29, 1983, as amended at 49 FR 26714, June 29, 1984; 
53 FR 11063, Apr. 5, 1988; 61 FR 5506, Feb. 13, 1996; 61 FR 8873, Mar. 
6, 1996; 62 FR 61625, Nov. 19, 1997]



Sec.  520.2612  Trimethoprim and sulfadiazine oral suspension.

    (a) Specifications. Each milliliter of oral suspension contains 60 
milligrams of drug (10 milligrams of trimethoprim and 50 milligrams of 
sulfadiazine).
    (b) Sponsor. See No. 000061 in Sec.  510.600 of this chapter.
    (c) Conditions of use. Dogs--(1) Dosage. 1 milliliter (10 milligrams 
of trimethoprim and 50 milligrams of sulfadiazine) per 5 pounds of body 
weight.
    (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. For oral use only. Administer the recommended dose 
once daily or one-half the recommended daily dose every 12 hours. 
Administer for 2 to 3 days after symptoms have subsided. If no 
improvement is seen in 3 days, discontinue therapy and reevaluate 
diagnosis. Do not treat for more than 14 consecutive days. During long-
term treatment, a complete blood count is recommended. The drug should 
not be used in patients showing marked liver parenchymal damage or blood 
dyscrasia, nor in those with a history of sulfonamide sensitivity. 
Federal law restricts this drug to use by or on the order of a licensed 
veterinarian.

[50 FR 19168, May 7, 1985, as amended at 61 FR 8873, Mar. 6, 1996; 62 FR 
61625, Nov. 19, 1997]



Sec.  520.2613  Trimethoprim and sulfadiazine powder.

    (a) Specifications. Each gram of powder contains 67 milligrams of 
trimethoprim and 333 milligrams of sulfadiazine.
    (b) Sponsor. See No. 000009 and 058711 in Sec.  510.600(c) of this 
chapter.
    (c) Conditions of use: Horses--(1) Dosage. 3.75 grams of powder per 
110 pounds (50 kilograms) of body weight per day.
    (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. Administer orally in a small amount of feed, as a 
single daily dose, for 5 to 7 days. Continue therapy for 2 to 3 days 
after clinical signs have subsided. If no improvement is seen in 3 to 5 
days, reevaluate diagnosis. A complete blood count should be done 
periodically with prolonged use. Not for use in horses intended for 
food. Federal law restricts this drug to use by or on the order of a 
licensed veterinarian.

[58 FR 36135, July 6, 1993, as amended by 64 FR 68289, Dec. 7, 1999]



Sec.  520.2640  Tylosin.

    (a) Specifications. Tylosin is the antibiotic substance produced by 
growth of Streptromyces fradiae or the same antibiotic substance 
produced by any other means. Tylosin, present as the tartrate

[[Page 214]]

salt, conforms to the appropriate antibiotic standard. Tylosin contains 
at least 95 percent tylosin as a combination of tylosin A, tylosin B, 
tylosin C, and tylosin D of which at least 80 percent is tylosin A as 
determined by a method entitled ``Determination of Factor Content in 
Tylosin by High Performance Liquid Chromatography,'' which is 
incorporated by reference. Copies are available from the Dockets 
Management Branch (HFA-305), Food and Drug Administration, rm. 1-23, 
12420 Parklawn Dr., Rockville, MD 20857, or available for inspection at 
the Office of the Federal Register, 800 North Capitol Street, NW., suite 
700, Washington, DC 20001.
    (b) Sponsor. See No. 000986 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.  556.740 of this chapter.
    (e) Conditions of use. It is used in drinking water of animals as 
follows:
    (1) Chickens--(i) Amount. 2 grams per gallon.
    (ii) Indications for use. Aid in the treatment of chronic 
respiratory disease (CRD) caused by Mycoplasma gallisepticum sensitive 
to tylosin in broiler and replacement chickens. For the control of 
chronic respiratory disease (CRD) caused by Mycoplasma gallisepticum 
sensitive to tylosin at time of vaccination or other stress in chickens. 
For the control of chronic respiratory disease (CRD) caused by 
Mycoplasma synoviae sensitive to tylosin in broiler chickens.
    (iii) Limitations. Do not use in layers producing eggs for human 
consumption; administer from 1 to 5 days as sole source of drinking 
water; treated chickens should consume enough medicated drinking water 
to provide 50 milligrams of tylosin per pound of body weight per day; 
prepare a fresh solution every 3 days; do not administer within 24 hours 
of slaughter .
    (2) Turkeys--(i) Amount. 2 grams per gallon.
    (ii) Indications for use. Maintaining weight gains and feed 
efficiency in the presence of infectious sinusitis caused by Mycoplasma 
gallisepticum sensitive to tylosin.
    (iii) Limitations. Do not use in layers producing eggs for human 
consumption; administer from 2 to 5 days as sole source of drinking 
water; treated turkeys should consume enough medicated drinking water to 
provide 60 milligrams of tylosin per pound of body weight per day; 
prepare a fresh solution every 3 days; when sinus swelling is present, 
inject the sinus with tylosin injectable simultaneously with the 
drinking water treatment; do not administer within 5 days of slaughter.
    (3) Swine--(i) Amount. 0.25 gram per gallon.
    (ii) Indications for use. For the control and treatment of swine 
dysentery (bloody scours) caused by pathogens sensitive to tylosin.
    (iii) Limitations. As only source of drinking water for 3 to 10 
days, depending on the severity of the condition being treated: mix 
fresh solution daily; medication must be withheld from animals 48 hours 
prior to slaughter.

[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]



PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS--Table of Contents




Sec.
522.23 Acepromazine maleate injection.
522.44 Sterile sodium acetazolamide.
522.46 Alfaprostol.
522.56 Amikacin sulfate injection.
522.62 Aminopentamide hydrogen sulfate injection.
522.82 Aminopropazine fumarate sterile solution injection.
522.84 Beta-aminopropionitrile fumarate.
522.88 Sterile amoxicillin trihydrate for suspension.
522.90 Ampicillin implantation and injectible dosage forms.
522.90a Ampicillin trihydrate sterile suspension.
522.90b Ampicillin trihydrate for sterile suspension.
522.90c Ampicillin sodium for aqueous injection.
522.144 Arsenamide sodium aqueous injection.
522.147 Atipamezole hydrochloride.
522.150 Azaperone injection.
522.161 Betamethasone acetate and betamethasone disodium phosphate 
          aqueous suspension.

[[Page 215]]

522.163 Betamethasone dipropionate and betamethasone sodium phosphate 
          aqueous suspension.
522.204 Boldenone undecylenate injection.
522.234 Butamisole hydrochloride.
522.246 Butorphanol tartrate injection.
522.311 Carfentanil citrate injection.
522.313 Ceftiofur sodium powder for injection.
522.314 Ceftiofur hydrochloride.
522.380 Chloral hydrate, pentobarbital, and magnesium sulfate sterile 
          aqueous solution.
522.390 Chloramphenicol injection.
522.460 Cloprostenol sodium.
522.468 Colistimethate sodium powder for injection.
522.480 Repository corticotropin injection.
522.518 Cupric glycinate injection.
522.522 Danofloxacin.
522.533 Deslorelin acetate.
522.535 Desoxycorticosterone pivalate.
522.536 Detomidine hydrochloride injection.
522.540 Dexamethasone injection.
522.542 Dexamethasone-21-isonicotinate suspension.
522.563 Diatrizoate meglumine and diatrizoate sodium injection.
522.575 Diazepam injection.
522.650 Dihydrostreptomycin sulfate injection.
522.690 Dinoprost solution.
522.723 Diprenorphine hydrochloride injection.
522.770 Doramectin.
522.775 Doxapram hydrochloride injection.
522.778 Doxycycline hyclate.
522.784 Doxylamine succinate injection.
522.800 Droperidol and fentanyl citrate injection.
522.812 Enrofloxacin solution.
522.820 Erythromycin injection.
522.840 Estradiol.
522.842 Estradiol benzoate and testosterone propionate in combination.
522.850 Estradiol valerate and norgestomet in combination.
522.863 Ethylisobutrazine hydrochloride injection.
522.883 Etorphine hydrochloride injection.
522.900 Euthanasia solution.
522.914 Fenprostalene solution.
522.940 Colloidal ferric oxide injection.
522.955 Florfenicol.
522.960 Flumethasone implantation or injectable dosage forms.
522.960a Flumethasone suspension.
522.960b Flumethasone acetate injection.
522.960c Flumethasone solution.
522.970 Flunixin meglumine solution.
522.995 Fluprostenol sodium injection.
522.1002 Follicle stimulating hormone.
522.1004 Fomepizole.
522.1010 Furosemide.
522.1020 Gelatin solution.
522.1044 Gentamicin sulfate injection.
522.1055 Gleptoferron injection.
522.1066 Glycopyrrolate injection.
522.1077 Gonadorelin injectable.
522.1078 Gonadorelin diacetate tetrahydrate.
522.1079 Serum gonadotropin and chorionic gonadotropin.
522.1081 Chorionic gonadotropin for injection; chorionic gonadotropin 
          suspension.
522.1085 Guaifenesin sterile powder.
522.1086 Guaifenesin injection.
522.1125 Hemoglobin glutamer-200 (bovine).
522.1145 Hyaluronate sodium injection.
522.1150 Hydrochlorothiazide injection.
522.1155 Imidocarb dipropionate sterile powder.
522.1156 Imidocarb dipropionate solution.
522.1182 Iron dextran complex injection.
522.1183 Iron hydrogenated dextran injection.
522.1192 Ivermectin injection.
522.1193 Ivermectin and clorsulon injection.
522.1204 Kanamycin sulfate injection.
522.1222 Ketamine hydrochloride injectable dosage forms.
522.1222a Ketamine.
522.1222b Ketamine hydrochloride with promazine hydrochloride and 
          aminopentamide hydrogen sulfate injection.
522.1225 Ketoprofen solution.
522.1228 [Reserved]
522.1244 Levamisole phosphate injection.
522.1260 Lincomycin.
522.1289 Lufenuron suspension.
522.1290 Luprostiol sterile solution.
522.1335 Medetomidine hydrochloride injection.
522.1350 Melatonin implant.
522.1362 Melarsomine dihydrochloride for injection.
522.1372 Mepivacaine hydrochloride injection.
522.1380 Methocarbamol injection.
522.1410 Sterile methylprednisolone acetate suspension.
522.1451 Moxidectin.
522.1452 Nalorphine hydrochloride injection.
522.1462 Naloxone hydrochloride injection.
522.1465 Naltrexone hydrochloride injection.
522.1468 Naproxen for injection.
522.1484 Neomycin sulfate sterile solution.
522.1503 Neostigmine methylsulfate injection.
522.1610 Oleate sodium solution.
522.1620 Orgotein for injection.
522.1642 Oxymorphone hydrochloride injection.
522.1660 Oxytetracycline injection.
522.1662 Oxytetracycline hydrochloride implantation or injectable dosage 
          forms.
522.1662a Oxytetracycline hydrochloride injection.
522.1662b Oxytetracycline hydrochloride with lidocaine injection.
522.1680 Oxytocin injection.
522.1696 Penicillin G procaine implantation and injectable dosage forms.

[[Page 216]]

522.1696a Penicillin G benzathine and penicillin G procaine sterile 
          suspension.
522.1696b Penicillin G procaine aqueous suspension.
522.1696c Penicillin G procaine in oil.
522.1698 Pentazocine lactate injection.
522.1704 Sodium pentobarbital injection.
522.1720 Phenylbutazone injection.
522.1820 Pituitary luteinizing hormone for injection.
522.1850 Polysulfated glycosaminoglycan.
522.1862 Sterile pralidoxime chloride.
522.1870 Praziquantel injectable solution.
522.1881 Sterile prednisolone acetate aqueous suspension.
522.1883 Prednisolone sodium phosphate injection, sterile.
522.1884 Prednisolone sodium succinate injection.
522.1885 Prednisolone tertiary butylacetate suspension.
522.1890 Sterile prednisone suspension.
522.1920 Prochlorperazine, isopropamide for injection.
522.1940 Progesterone and estradiol benzoate in combination.
522.1962 Promazine hydrochloride injection.
522.2002 Propiopromazine hydrochloride injection.
522.2005 Propofol injection.
522.2012 Prostalene solution.
522.2063 Pyrilamine maleate injection.
522.2100 Selenium, vitamin E injection.
522.2112 Sometribove zinc suspension.
522.2120 Spectinomycin dihydrochloride injection.
522.2121 Spectinomycin sulfate solution.
522.2150 Stanozolol sterile suspension.
522.2200 Sulfachlorpyridazine.
522.2220 Sulfadimethoxine injection.
522.2240 Sulfaethoxypyridazine.
522.2260 Sulfamethazine injectable solution.
522.2340 Sulfomyxin.
522.2404 Thialbarbitone sodium for injection.
522.2424 Sodium thiamylal for injection.
522.2444 Sodium thiopental implantation or injectable dosage forms.
522.2444a Sodium thiopental for injection.
522.2444b Sodium thiopental, sodium pentobarbital for injection.
522.2470 Tiletamine hydrochloride and zolazepam hydrochloride for 
          injection.
522.2471 Tilmicosin.
522.2474 Tolazoline hydrochloride injection.
522.2476 Trenbolone acetate.
522.2477 Trenbolone acetate and estradiol.
522.2478 Trenbolone acetate and estradiol benzoate.
522.2483 Sterile triamcinolone acetonide suspension.
522.2582 Triflupromazine hydrochloride injection.
522.2610 Trimethoprim and sulfadiazine sterile suspension.
522.2615 Tripelennamine hydrochloride injection.
522.2640 Tylosin injectable dosage forms.
522.2640a Tylosin injection.
522.2662 Xylazine hydrochloride injection.
522.2670 Yohimbine injectable.
522.2680 Zeranol.

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

    Source: 40 FR 13858, Mar. 27, 1975, unless otherwise noted.



Sec.  522.23  Acepromazine maleate injection.

    (a) Specifications. Each milliliter of sterile aqueous solution 
contains 10 milligrams of acepromazine maleate.
    (b) Conditions of use. See No. 000856 in Sec.  510.600(c) of this 
chapter for use in dogs, cats, and horses as follows:
    (1) Indications for use. It is used in dogs, cats, and horses as a 
tranquilizer.
    (2) Amount. Dogs: 0.25 to 0.5 milligram per pound of body weight; 
Cats: 0.5 to 1.0 milligram per pound of body weight; Horses: 2.0 to 4.0 
milligrams per 100 pounds of body weight.
    (c) Conditions of use. See No. 000010 in Sec.  510.600(c) of this 
chapter for use in dogs as follows:
    (1) Indications for use. It is used in dogs as an aid in 
tranquilization and as a preanesthetic agent.
    (2) Amount. Dogs: 0.25 to 0.5 milligram per pound of body weight.
    (3) Limitations. The drug is administered intravenously, 
intramuscularly or subcutaneously with the dosage individualized 
depending upon the degree of tranquilization required. Federal law 
restricts this drug to use by or on the order of a licensed 
veterinarian.

[46 FR 43831, Sept. 1, 1981, as amended at 53 FR 40727, Oct. 18, 1988; 
62 FR 35076, June 30, 1997]



Sec.  522.44  Sterile sodium acetazolamide.

    (a) Specifications. Sterile sodium acetazolamide contains 
acetazolamide sodium complying with United States Pharmacopeia as a 
sterile powder with directions for reconstituting the product with 
sterile distilled water to furnish a product having a concentration of 
100 milligrams acetazolamide activity per milliliter.
    (b) Sponsor. See No. 010042 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use. (1) It is used as an aid in the treatment of 
dogs with mild congestive heart failure and for

[[Page 217]]

rapid reduction of intraocular pressure.\1\
---------------------------------------------------------------------------

    \1\ These conditions are NAS/NRC reviewed and deemed effective. 
Applications for these uses need not include effectiveness data as 
specified by Sec.  514.111 of this chapter, but may require 
bioequivalency and safety information.
---------------------------------------------------------------------------

    (2) It is administered intramuscularly or intraperitoneally to dogs 
at a level of 5 to 15 milligrams per pound of body weight daily 
preferably administered in two or more divided doses.\1\
    (3) For use only by or on the order of a licensed veterinarian.\1\



Sec.  522.46  Alfaprostol.

    (a) Specifications. Each milliliter of sterile solution contains 1 
milligram of alfaprostol.
    (b) Sponsor. No. 055882 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use. It is used in horses as follows:
    (1) Amount. For average mature mares, 6.0 micrograms per kilogram of 
body weight.
    (2) Indications for use. To cause luteolysis in mares with active 
corpora lutea.
    (3) Limitations. For intramuscular or subcutaneous use as a single 
injection. Not for horses intended for food. Alfaprostol is readily 
absorbed through the skin and can cause abortion and/or bronchial 
spasms. Women of childbearing age, asthmatics, and persons with 
bronchial and other respiratory problems should exercise extreme caution 
when handling this product. Federal law restricts this drug to use by or 
on the order of a licensed veterinarian.

[48 FR 43300, Sept. 23, 1983, as amended at 53 FR 40057, Oct. 13, 1988]



Sec.  522.56  Amikacin sulfate injection.

    (a) Specifications. Each milliliter of sterile aqueous solution 
contains 50 milligrams of amikacin (as the sulfate).
    (b) Sponsor. See Nos. 000856 and 059130 in Sec.  510.600(c) of this 
chapter.
    (c) Conditions of use--(1) Amount. 5 milligrams per pound of body 
weight twice daily.
    (2) Indications for use. The drug is used in dogs 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. The drug is administered intramuscularly or 
subcutaneously. Treat dogs with skin and soft tissue infections for a 
minimum of 7 days and those with genitourinary infections for 7 to 21 
days or until culture is negative and asymptomatic. If no response is 
observed after 3 days of treatment, therapy should be discontinued and 
the case reevaluated. Maximum duration of therapy should not exceed 30 
days. Systemic aminoglycoside therapy is contraindicated in dogs with 
seriously impaired renal function. Not for use in breeding dogs as 
reproductive studies have not been conducted. Use with extreme caution 
in dogs in which hearing acuity is required for functioning. Federal law 
restricts this drug to use by or on the order of a licensed 
veterinarian.

[52 FR 11816, Apr. 13, 1987; 52 FR 15412, Apr. 28, 1987, as amended at 
53 FR 27851, July 25, 1988; 62 FR 23357, Apr. 30, 1997]



Sec.  522.62  Aminopentamide hydrogen sulfate injection.

    (a) Chemical name. 4-(Dimethylamino)-2,2-diphenylvaleramide hydrogen 
sulfate.
    (b) Specifications. It is sterile and each milliliter of aqueous 
solution contains 0.5 milligram of the drug.
    (c) Sponsor. See No. 000856 in Sec.  510.600(c) of this chapter.
    (d) Conditions of use. (1) It is intended for use in dogs and cats 
only for the treatment of vomiting and/or diarrhea, nausea, acute 
abdominal visceral spasm, pylorospasm, or hypertrophic gastritis.
    Note: Not for use in animals with glaucoma because of the occurrence 
of mydriasis.
    (2) Dosage is administered by subcutaneous or intramuscular 
injection every 8 to 12 hours, as follows:

------------------------------------------------------------------------
                                                               Dosage in
                 Weight of animal in pounds                   milligrams
------------------------------------------------------------------------
Up to 10....................................................         0.1
11 to 20....................................................         0.2
21 to 50....................................................         0.3
51 to 100...................................................         0.4
Over 100....................................................         0.5
------------------------------------------------------------------------


[[Page 218]]


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.
    (3) For use only by or on the order of a licensed veterinarian.

[40 FR 13858, Mar. 27, 1975, as amended at 53 FR 27851, July 25, 1988



Sec.  522.82  Aminopropazine fumarate sterile solution injection.

    (a) Specifications. Each milliliter of aminopropazine fumarate 
sterile aqueous solution, veterinary, contains aminopropazine fumarate 
equivalent to 25 milligrams of aminopropazine base.
    (b) Sponsor. See No. 000061 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use. (1) The drug is used for reducing excessive 
smooth muscle contractions, such as occur in urethral spasms associated 
with urolithiasis in cats and dogs and in colic spasms in horses.\1\
---------------------------------------------------------------------------

    \1\ These conditions are NAS/NRC reviewed and deemed effective. 
Applications for these uses need not include effectiveness data as 
specified by Sec.  514.111 of this chapter, but may require 
bioequivalency and safety information.
---------------------------------------------------------------------------

    (2) It is administered intramuscularly or intravenously to dogs and 
cats at a level of 1 to 2 milligrams per pound of body weight. It is 
administered intramuscularly or intravenously to horses at a level of 
0.25 milligrams per pound of body weight. Dosage can be repeated every 
12 hours, as indicated.\1\
    (3) Not for use in animals intended for food purposes.\1\
    (4) For use only by or on the order of a licensed veterinarian.\1\

[40 FR 13858, Mar. 27, 1975, as amended at 46 FR 48642, Oct. 2, 1981; 61 
FR 8873, Mar. 6, 1996; 62 FR 61625, Nov. 19, 1997]



Sec.  522.84  Beta-aminopropionitrile fumarate.

    (a) Specifications. Each vial contains 7.0 milligrams of beta-
aminopropionitrile fumarate sterile lyophilized powder which is 
reconstituted for injection with 10 milliliters of sterile physiologic 
saline, USP.
    (b) Sponsor. See No. 064146 in Sec.  510.600(c) of this chapter.
    (c) [Reserved]
    (d) Conditions of use--(1) Horses--(i) Amount. 7 milligrams (10 
milliliters) intralesionally every other day for 5 treatments beginning 
about 30 days after initial injury.
    (ii) Indications for use. For treatment of tendinitis of the 
superficial digital flexor tendon (SDFT) in the adult horse where there 
is sonographic evidence of fiber tearing.
    (iii) Limitations. Single dose container for intralesional 
injection. Do not use in horses with dermal irritation or open skin 
lesions in the injection area. Do not administer intraarticularly, into 
the tendon sheath, or in the presence of concurrent limb fractures. Do 
not use in breeding animals since the effects on fertility, pregnancy, 
or fetal health have not been determined. Not for use in horses intended 
for food. Federal law restricts this drug to use by or on the order of a 
licensed veterinarian.
    (2) [Reserved]

[63 FR 44382, Aug. 19, 1998]



Sec.  522.88  Sterile amoxicillin trihydrate for suspension.

    (a)(1) Specifications. Each vial contains 3 grams of amoxicillin as 
the trihydrate. The powder is reconstituted with sterile water for 
injection USP to a concentration of 100 or 250 milligrams per milliliter 
for use as in paragraph (d) of this section.
    (2) Each vial contains 25 grams of amoxicillin as the trihydrate. 
The powder is reconstituted with sterile water for injection USP to a 
concentration of 250 milligrams per milliliter for use as in paragraph 
(e).
    (b) Sponsor. See 000069 in Sec.  510.600(c) of this chapter.
    (c) Related tolerance. See Sec.  556.38 of this chapter.
    (d) Conditions of use in dogs and cats--(1) Amount. 5 milligrams per 
pound of body weight daily.
    (2) Indications for use--(i) Dogs. 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.

[[Page 219]]

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.
    (ii) Cats. Treatment of infections caused by susceptible strains of 
organisms as follows: Upper respiratory infections due to S. aureus, 
Staphylococcus spp., Streptococcus spp., Hemophilus 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.
    (3) Limitations. For use in dogs and cats only. Administer once 
daily for up to 5 days by intramuscular or subcutaneous injection. 
Continue treatment for 48 hours after the animal has become afebrile or 
asymptomatic. If no improvement is seen within 5 days, review the 
diagnosis and change therapy. As with all antibiotics, appropriate in 
vitro culturing susceptibility testing of samples taken before treatment 
should be conducted. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.
    (e) Condition of use. Cattle--(1) Amount. 3 to 5 milligrams per 
pound of body weight once a day according to the animal being treated, 
the severity of infection, and the animal's response.
    (2) Indications for use.-- Treatment of diseases due to amoxicillin-
susceptible organisms as follows: Respiratory tract infections (shipping 
fever, pneumonia) due to P. multocida, P. hemolytica, Hemophilus spp., 
Staphylococcus spp., and Streptococcus spp. and acute necrotic 
pododermatitis (foot rot) due to Fusobacterium necrophorum.
    (3) Limitations. Administer once daily for up to 5 days by 
intramuscular or subcutaneous injection. Continue treatment for 48 to 72 
hours after the animal has become afebrile or asymptomatic. Do not 
continue treatment beyond 5 days. Treated animals must not be 
slaughtered for food during treatment and for 25 days after the last 
treatment. As with all antibiotics, appropriate in vitro culturing and 
susceptibility testing of samples taken before treatment should be 
conducted. Milk from treated cows must not be used for human consumption 
during treatment or for 96 hours (8 milkings) after last treatment. 
Maximum volume per injection should not exceed 30 milliliters. Federal 
law restricts this drug to use by or on the order of a licensed 
veterinarian.

[57 FR 37330, Aug. 18, 1992; 60 FR 55659, Nov. 2, 1995]



Sec.  522.90  Ampicillin implantation and injectible dosage forms.



Sec.  522.90a  Ampicillin trihydrate sterile suspension.

    (a) Specifications. Each milliliter contains ampicillin trihydrate 
equivalent to 200 milligrams of ampicillin.
    (1) Sponsor. See No. 053501 in Sec.  510.600(c) of this chapter.
    (2) Related tolerances. See Sec.  556.40 of this chapter.
    (3) Conditions of use--(i) Calves.
    (A) Amount. For enteritis: 3 milligrams per pound of body weight, 
intramuscularly, once or twice daily, for up to 3 days. For pneumonia: 3 
milligrams per pound of body weight, intramuscularly, twice daily, for 
up to 3 days.
    (B) Indications for use. Treatment of bacterial enteritis caused by 
Escherichia coli and bacterial pneumonia caused by Pasteurella spp. 
susceptible to ampicillin.
    (C) Limitations. Not for use in other animals raised for food 
production. 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.
    (ii) Dogs. (A) Amount. 3 to 6 milligrams per pound of body weight 
intramuscularly, once or twice daily.
    (B) Indications for use. Treatment of respiratory tract infections 
due to E. coli, Pseudomonas spp., Proteus spp., Staphylococcus spp., and 
Streptococcus

[[Page 220]]

spp.; tonsillitis due to E. coli, Pseudomonas spp., Streptococcus spp., 
and Staphylococcus spp.; generalized infections (septicemia) associated 
with abscesses, lacerations, and wounds due to Staphylococcus spp. and 
Streptococcus spp.
    (C) Limitations. Continue treatment at least 48 hours after the 
animal's temperature has returned to normal and other signs of infection 
have subsided. Usual treatment is 3 to 5 days. Federal law restricts 
this drug to use by or on the order of a licensed veterinarian.
    (iii) Cats. (A) Amount. 5 to 10 milligrams per pound of body weight 
intramuscularily or subcutaneously, once or twice daily.
    (B) Indications for use. Treatment of generalized infections 
(septicemia) associated with abscesses, lacerations, and wounds due to 
Staphylococcus spp., Streptococcus spp., and Pasteurella spp.
    (C) Limitations. Continue treatment at least 48 hours after the 
animal's temperature has returned to normal and other signs of infection 
have subsided. Usual treatment is 3 to 5 days. Federal law restricts 
this drug to use by or on the order of a licensed veterinarian.
    (iv) Swine. (A) Amount. 3 milligrams per pound of body weight, 
intramuscularily, once or twice daily, for up to 3 days.
    (B) Indications for use. Treatment of bacterial enteritis 
(colibacillosis) caused by E. coli and bacterial pneumonia caused by 
Pasteurella spp. susceptible to ampicillin.
    (C) 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.
    (b) Specifications. Each milliliter contains ampicillin trihydrate 
equivalent to 150 milligrams of ampicillin.
    (1) Sponsor. See No. 000069 in Sec.  510.600(c) of this chapter.
    (2) Related tolerances. See Sec.  556.40 of this chapter.
    (3) Conditions of use. Dogs--(i) Amount. 3 to 5 milligrams of 
ampicillin per pound of body weight, once a day for up to 4 days.
    (ii) Indications for use. 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. Administer intramuscularly. If continued 
treatment is indicated, oral dosage is recommended. As with all 
antibiotics, appropriate in vitro culturing and susceptibility tests of 
samples taken before treatment are recommended. Federal law restricts 
this drug to use by or on the order of a licensed veterinarian.

[57 FR 37330, Aug. 18, 1992, as amended at 60 FR 55659, Nov. 2, 1995]



Sec.  522.90b  Ampicillin trihydrate for sterile suspension.

    (a) Specifications. When reconstituted, each milliliter contains 
ampicillin trihydrate equivalent to 50, 100, or 250 milligrams of 
ampicillin.
    (b) Sponsor. (1) See 000856 in Sec.  510.600(c) of this chapter for 
use of 50, 100, and 250 milligrams per milliliter ampicillin suspension.
    (2) See 010515 in Sec.  510.600(c) of this chapter for use of 100 
and 250 milligrams per milliliter ampicillin suspension.
    (c) Related tolerances. See Sec.  556.40 of this chapter.
    (d) Conditions of use. (1) Dogs--(i) Amount. 3 milligrams per pound 
of body weight twice daily.
    (ii) Indications for use. Treatment against 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. Administer by subcutaneous or intramuscular 
injection. Treatment should be continued for 48 to 72 hours after the 
animal has become afebrile or asymptomatic. Federal law restricts this 
drug to use by or on the order of a licensed veterinarian.
    (2) Cats--(i) Amount. 3 milligrams per pound of body weight twice 
daily.

[[Page 221]]

    (ii) Indications for use. Treatment against 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. Administer by subcutaneous or intramuscular 
injection. Treatment should be continued for 48 to 72 hours after the 
animal has become afebrile or asymptomatic. Federal law restricts this 
drug to use by or on the order of a licensed veterinarian.
    (3) Cattle--(i) Amount. 2 to 5 milligrams per pound of body weight 
once daily by intramuscular injection.
    (ii) Indications for use. 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]



Sec.  522.90c  Ampicillin sodium for aqueous injection.

    (a) Specifications. When reconstituted, each milliliter contains 
ampicillin sodium equivalent to 300 milligrams of ampicillin.
    (b) Sponsor. See No. 000069 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use. Horses--(1) Amount: 3 milligrams per pound of 
body weight twice daily.
    (2) Indications for use. Treatment of respiratory tract infections 
(pneumonia and strangles) due to Staphylococcus spp., 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. Administer either intravenously or intramuscularly. 
Treatment should be continued 48 hours after all symptoms have subsided. 
If no response is seen in 4 to 5 days, reevaluate diagnosis. Not for use 
in horses or other animals which are raised for food production. Federal 
law restricts this drug to use by or on the order of a licensed 
veterinarian.

[57 FR 37331, Aug. 18, 1992, as amended at 60 FR 55659, Nov. 2, 1995]



Sec.  522.144  Arsenamide sodium aqueous injection.

    (a) Chemical name. [[(p-Carbamoylphenyl) arsylene]dithio diacetic 
acid, sodium salt.
    (b) Specifications. The drug is a sterile aqueous solution and each 
milliliter contains 10.0 milligrams of arsenamide sodium.
    (c) Sponsor. See No. 050604 in Sec.  510.600(c) of this chapter.
    (d) Conditions of use. (1) For the treatment and prevention of 
canine heartworm disease caused by Dirofilaria immitis.
    (2) It is administered intravenously at 0.1 milliliter per pound of 
body weight (1.0 milliliter for every 10 pounds) twice a day for 2 days. 
For dogs in poor condition, particularly those with evidence of reduced 
liver function, a more conservative dosage schedule of 0.1 milliliter 
per pound of body weight daily for 15 days is recommended.
    (3) Restricted to use only by or on the order of a licensed 
veterinarian.

[40 FR 13858, Mar. 27, 1975, as amended at 43 FR 27785, June 27, 1978; 
45 FR 56798, Aug. 26, 1980; 55 FR 26683, June 29, 1990]



Sec.  522.147  Atipamezole hydrochloride.

    (a) Specifications. Each milliliter of sterile injectable solution 
contains 5.0 milligrams of atipamezole hydrochloride.
    (b) Sponsor. See No. 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 medetomidine used.

[[Page 222]]

    (2) Indications for use. To reverse clinical effects of the sedative 
and analgesic agent medetomidine hydrochloride.
    (3) Limitations. For intramuscular use only. Not recommended for use 
in pregnant or lactating animals, or animals intended for breeding. 
Atipamezole has not been evaluated in breeding animals. 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]



Sec.  522.150  Azaperone injection.

    (a) Specifications. Each milliliter of sterile aqueous solution 
contains 40 milligrams of azaperone.
    (b) Sponsor. See No. 000061 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use--(1) Indications for use. Control of 
aggressiveness when mixing or regrouping weanling or feeder pigs 
weighing up to 80 pounds.
    (2) Dosage. 2.2 milligrams per kilogram (1 milligram per pound).
    (3) Limitations. Inject by deep intramuscular injection. Federal law 
restricts this drug to use by or on the order of a licensed 
veterinarian.

[48 FR 48229, Oct. 18, 1983, as amended at 62 FR 61625, Nov. 19, 1997]



Sec.  522.161  Betamethasone acetate and betamethasone disodium phosphate aqueous suspension.

    (a) Chemical names. Betamethasone acetate: 9-[alpha]-Fluoro-16-
[beta]-methylprednisolone - 21 - acetate 
(C24H31FO6). Betamethasone disodium 
phosphate: 9-[alpha]-Fluoro-16-[beta]-methylprednisolone-21-disodium 
phosphate (C22H28FNa2O8P).
    (b) Specifications. The drug is a sterile aqueous suspension and 
each cubic centimeter contains: 12 milligrams of betamethasone acetate 
(equivalent to 10.8 milligrams of betamethasone), 3.9 milligrams of 
betamethasone disodium phosphate (equivalent to 3 milligrams of 
betamethasone), 2 milligrams of dibasic sodium phosphate, 5 milligrams 
of sodium chloride, 0.1 milligram of disodium EDTA, 0.5 milligram of 
polysorbate 80, 9 milligrams of benzyl alcohol, 5 milligrams of sodium 
carboxymethylcellulose, 1.8 milligrams of methylparaben, 0.2 milligram 
of propylparaben, hydrochloric acid and/or sodium hydroxide to adjust 
pH, and water for injection q.s.
    (c) Sponsor. See No. 000061 in Sec.  510.600(c) of this chapter.
    (d) Conditions of use. It is used or intended for use by intra-
articular injection of horses for the treatment of various inflammatory 
joint conditions; for example, acute and traumatic lameness involving 
the carpel and fetlock joints. Administer from 2.5 to 5 cubic 
centimeters per dose. Dose may be repeated when necessary depending upon 
the duration of relief obtained. Not for use in horses intended for 
food. For use only by or on the order of a licensed veterinarian.

[40 FR13858, Mar. 27, 1975, as amended at 52 FR 7832, Mar. 13, 1987]



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.

[[Page 223]]

    (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.  522.204  Boldenone undecylenate injection.

    (a) Specifications. Each milliliter contains 25 or 50 milligrams of 
boldenone undecylenate in a sesame oil base.
    (b) Sponsor. See No. 053501 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use. (1) It is intended for use as an aid in 
treating debilitated horses following disease or overwork and 
overexertion when an improvement in weight, hair coat, or general 
physical condition is desired. The drug is given only as adjunctive 
therapy to other specific and supportive therapy for diseases, surgical 
cases, and traumatic injuries. Optimal results can be expected only when 
good management and feeding practices are followed.
    (2) It is administered intramuscularly at a dosage level of 0.5 
milligram per pound of body weight. Treatment may be repeated at 3-week 
intervals.
    (3) For use in horses only. Do not administer to horses intended for 
use as food. The effectiveness of the drug in stallions and pregnant 
mares has not been established, nor has the drug been shown not to be 
teratogenic in pregnant mares; therefore, this drug should not be used 
in stallions and pregnant mares.
    (4) 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 50 FR 41489, Oct. 11, 1985]



Sec.  522.234  Butamisole hydrochloride.

    (a) Specifications. The drug contains 11 milligrams of butamisole 
per milliliter in a solution consisting of 70 percent propylene glycol, 
4 percent benzyl alcohol and distilled water.
    (b) Sponsor. See Nos. 000859 and 053501 in Sec.  510.600(c) of this 
chapter.
    (c) Conditions of use. (1) The drug is administered by subcutaneous 
injection to dogs for the treatment of infections with whipworms 
(Trichuris vulpis), and the hookworm (Ancylostoma caninum).
    (2) The drug is administered subcutaneously at the rate of 0.1 
milliliter per pound of body weight. 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.
    (3) Federal law restricts this drug to use by or on the order of a 
licensed veterinarian.

[43 FR 15625, Apr. 14, 1978. Redesignated at 43 FR 60883, Dec. 29, 1978, 
and amended at 45 FR 29789, May 6, 1980; 51 FR 19329, May 29, 1986; 67 
FR 63055, Oct. 10, 2002]



Sec.  522.246  Butorphanol tartrate injection.

    (a) Specifications. Each milliliter of aqueous solution contains 
either 0.5, 2 or 10 milligrams of butorphanol (as butorphanol tartrate).
    (b) Sponsors. Approval to firms identified in Sec.  510.600(c) of 
this chapter for use as indicated:
    (1) See No. 057926 for use as in paragraph (c)(2) of this section.
    (2) See No. 000856 for use as in paragraphs (c)(1), (c)(2), and 
(c)(3) of this section.
    (c) Conditions of use--(1) Dogs--(i) Amount. 0.025 milligram of 
butorphanol base activity per pound of body weight (equivalent to 0.5 
milliliter per 10 pounds), using 0.5 milligram per milliliter solution.
    (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 224]]

    (iii) Limitations. For subcutaneous injection in dogs only. Repeat 
at intervals of 6 to 12 hours as required. If necessary, increase dose 
to maximum of 0.05 milligram per pound of body weight. Treatment should 
not normally be required for longer than 7 days. Federal law restricts 
this drug to use by or on the order of a licensed veterinarian.
    (2) Horses--(i) Amount. 0.05 milligram of butorphanol base activity 
per pound of body weight (0.1 milligram/kilogram) using 10 milligrams 
per milliliter solution.
    (ii) Indications for use. For the relief of pain associated with 
colic and postpartum pain in adult horses and yearlings.
    (iii) Limitations. For intravenous use in horses only. Dose may be 
repeated within 3 to 4 hours. Treatment should not exceed 48 hours. Not 
for use in horses intended for food. Federal law restricts this drug to 
use by or on the order of a licensed veterinarian.
    (3) Cats--(i) Amount. 0.2 milligram of butorphanol base activity per 
pound of body weight (0.4 milligram/kilogram), using 2 milligrams per 
milliliter solution.
    (ii) Indications for use. For the relief of pain in cats caused by 
major or minor trauma, or pain associated with surgical procedures.
    (iii) Limitations. For subcutaneous injection in cats only. Dose may 
be repeated up to 4 times per day. Do not treat for more than 2 days. 
Safety for use in pregnant female cats, breeding male cats or kittens 
less than 4 months of age has not been determined. Federal law restricts 
this drug to use by or on the order of a licensed veterinarian.

[45 FR 29276, May 2, 1980, as amended at 50 FR 24508, June 11, 1985; 53 
FR 27851, July 25, 1988; 59 FR 41665, Aug. 15, 1994; 63 FR 66432, Dec. 
2, 1998]



Sec.  522.311  Carfentanil citrate injection.

    (a) Specifications. Each milliliter of sterile aqueous solution 
contains 3 milligrams of carfentanil citrate.
    (b) Sponsor. See No. 053923 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use--(1) Amount. 5 to 20 micrograms per kilogram 
(.005 to .020 milligram per kilogram) of body weight.
    (2) Indications for use. For immobilizing free ranging and confined 
members of the family Cervidae (deer, elk, and moose).
    (3) Limitations. Inject into large muscle of neck, shoulder, back, 
or hindquarter. Avoid intrathoracic, intra-abdominal, or subcutaneous 
injection. To reverse effect, use 7 milligrams of diprenorphine for each 
milligram of carefentanil citrate, given intravenously or one-half 
intravenously and one-half intramuscularly or subcutaneously. Do not use 
in domestic animals intended for food. Do not use 30 days before or 
during hunting season. Do not use in animals that display clinical signs 
of severe cardiovascular or respiratory disease. Available data are 
inadequate to recommend use in pregnant animals. Avoid use during 
breeding season. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian. The licensed veterinarian shall be a 
veterinarian engaged in zoo and exotic animal practice, wildlife 
management programs, or research.

[53 FR 40057, Oct. 13, 1988]



Sec.  522.313  Ceftiofur sodium powder for injection.

    (a) Specifications. Ceftiofur sodium sterile powder for injection is 
reconstituted to form an aqueous solution containing the equivalent of 
50 milligrams ceftiofur per milliliter.
    (b) Sponsor. See 000009 in Sec.  510.600 of this chapter.
    (c) Related tolerances. See Sec.  556.113 of this chapter.
    (d) Conditions of use--(1) Cattle--(i) Amount. 0.5 to 1.0 milligram 
of ceftiofur per pound of body weight intramuscularly or subcutaneously.
    (ii) Indications for use. Treatment of bovine respiratory disease 
(shipping fever, pneumonia) associated with Pasteurella hemolytica, P. 
multocida, and Haemophilus somnus in beef and dairy cattle. Also, for 
the treatment of acute bovine interdigitial necrobacillosis (foot rot, 
pododermatitis) associated with Fusobacterium necrophorum and 
Bacteroides melaninogenicus.
    (iii) Limitations. Treatment should be repeated once every 24 hours 
for 3 days.

[[Page 225]]

Treat for an additional 2 days if animals do not show a satisfactory 
response. Do not use in animals previously found to be hypersensitive to 
the drug. Use of doses in excess of those indicated may result in 
illegal residues in tissues. Federal law restricts this drug to use by 
or on the order of a licensed veterinarian.
    (2) Swine--(i) Amount. 3 to 5 milligrams per kilogram (1.36 to 2.27 
milligrams per pound) of body weight.
    (ii) Indications for use. For treatment and control of swine 
bacterial respiratory disease (swine bacterial pneumonia) associated 
with Actinobacillus (Haemophilus) pleuropneumoniae, Pasteurella 
multocida, Salmonella choleraesuis, and Streptococcus suis Type 2.
    (iii) Limitations. For intramuscular use only. Treatment should be 
repeated at 24 hour intervals for a total of 3 consecutive days. Do not 
use in animals previously found to be hypersensitive to the drug. Use of 
dosages in excess of those indicated or route of administration other 
than that recommended may result in illegal residues in tissues. Safety 
of ceftiofur has not been determined in breeding swine. Federal law 
restricts this drug to use by or on the order of a licensed 
veterinarian.
    (3) Day-old chickens--(i) Amount. 0.08 to 0.20 milligram per chick.
    (ii) Indications for use. For control of early mortality associated 
with Escherichia coli organisms susceptible to ceftiofur.
    (iii) Limitations. For subcutaneous use in the neck of day-old 
chicks only. As a single dose only. Federal law restricts this drug to 
use by or on the order of a licensed veterinarian.
    (4) Day-old turkey poults--(i) Amount. 0.17 to 0.5 milligram per 
poult.
    (ii) Indications for use. For control of early mortality associated 
with E. coli organisms susceptible to ceftiofur.
    (iii) Limitations. For subcutaneous use in the neck of day-old 
poults only. As a single dose only. Federal law restricts this drug to 
use by or on the order of a licensed veterinarian.
    (5) Horses--(i) Amount. 2.2 to 4.4 milligrams per kilogram (1.0 to 
2.0 milligrams per pound) of body weight.
    (ii) Indications for use. For treatment of respiratory infections in 
horses associated with Streptococcus zooepidemicus.
    (iii) Limitations. For intramuscular use only. 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 
milliliters should be administered per injection site. Not for use in 
horses intended for food. Do not use in animals previously found to be 
hypersensitive to the drug. Federal law restricts this drug to use by or 
on the order of a licensed veterinarian.
    (6) Dogs--(i) Amount. 1.0 milligrams per pound (2.2 milligrams per 
kilogram) of body weight.
    (ii) Indications for use. Treatment of canine urinary tract 
infections associated with Escherichia coli and Proteus mirabilis.
    (iii) Limitations. For subcutaneous use only. Treatment should be 
repeated at 24-hour intervals, continued for 48 hours after clinical 
signs have disappeared, for 5 to 14 days. Do not use in animals found to 
be hypersensitive to the drug. Federal law restricts this drug to use by 
or on the order of a licensed veterinarian.
    (7) Sheep--(i) Amount. 0.5 to 1.0 milligram per pound (1.1 to 2.2 
milligrams per kilogram) of body weight.
    (ii) Indications for use. For treatment of sheep respiratory disease 
(pneumonia) associated with Pasteurella haemolytica and/or P. multocida.
    (iii) Limitations. For intramuscular use only. Treatment should be 
repeated at 24 hour intervals for a total of 3 consecutive days. 
Additional treatments may be given on days 4 and 5 for animals which do 
not show satisfactory response. Use of dosages in excess of those 
indicated or by unapproved routes of administration may result in 
illegal residues in tissues. Federal law restricts this drug to use by 
or on the order of a licensed veterinarian.
    (8) Goats--(i) Amount. 0.5 to 1.0 milligram per pound of body weight 
by intramuscular injection at 24-hour intervals for a total of 3 
consecutive days. Additional treatments may be given on days 4 and 5 for 
animals that do not show satisfactory response.
    (ii) Indications for use. For treatment of caprine respiratory 
disease (goat

[[Page 226]]

pneumonia) associated with Pasteurella haemolytica and P. multocida.
    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

[53 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]



Sec.  522.314  Ceftiofur hydrochloride.

    (a) Specifications. Each milliliter of suspension contains ceftiofur 
hydrochloride equivalent to 50 milligrams (mg) of ceftiofur.
    (b) Sponsor. See No. 000009 in Sec.  510.600(c) of this chapter.
    (c) Related tolerances. See Sec.  556.113 of this chapter.
    (d) 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 (Haemophilus) pleuropneumoniae, Pastureurella 
multocida, Salmonella choleraesuis, and Streptococcus suis Type 2.
    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.
    (2) Cattle--(i) Dosage. 1.1 to 2.2 mg/kg of body weight by 
intramuscular or subcutaneous injection, at 24-hour intervals for 3 to 5 
consecutive days. For bovine respiratory disease, 2.2 mg/kg of body 
weight may be administered twice at a 48-hour interval. For acute 
metritis, administer 2.2 mg/kg of body weight daily for 5 consecutive 
days.
    (ii) Indications for use. For treatment of bovine respiratory 
disease (BRD, shipping fever, pneumonia) associated with Mannheimia spp. 
(Pasteurella haemolytica), P. multocida, and Haemophilus somnus; 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. Do not slaughter treated cattle for 48 hours (2 
days) after 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.

[61 FR 29479, June 11, 1996, as amended at 63 FR 53578, Oct. 6, 1998; 67 
FR 45901, July 11, 2002]



Sec.  522.380  Chloral hydrate, pentobarbital, and magnesium sulfate sterile aqueous solution.

    (a) [Reserved]
    (b)(1) Specifications. Chloral hydrate, pentobarbital, and magnesium 
sulfate sterile aqueous solution contains 42.5 milligrams of chloral 
hydrate, 8.86 milligrams of pentobarbital, and 21.2 milligrams of 
magnesium sulfate in each milliliter of sterile aqueous solution 
containing water, 33.8 percent propylene glycol, and 14.25 percent ethyl 
alcohol.
    (2) Sponsor. See No. 000856 in Sec.  510.600(c) of this chapter.
    (3) Conditions of use. (i) It is used for general anesthesia and as 
a sedative-relaxant in cattle and horses.
    (ii) For intravenous use only. The drug is administered at a dosage 
level of 20 to 50 milliliters per 100 pounds of body weight for general 
anesthesia until the desired effect is produced. Cattle usually require 
a lower dosage on the basis of body weight. When used as a sedative-
relaxant, it is administered at a level of one-fourth to one-half of the 
anesthetic dosage level.
    (iii) 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 45 FR 16482, Mar. 14, 1980]



Sec.  522.390  Chloramphenicol injection.

    (a) Specifications. Each milliliter contains 100 milligrams of 
chloramphenicol.
    (b) Sponsor. See Nos. 000069 and 059130 in Sec.  510.600(c) of this 
chapter.
    (c) Conditions of use. Dogs--(1) Amount. 5 to 15 milligrams per 
pound of

[[Page 227]]

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. 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 37331, Aug. 18, 1992, as amended at 65 FR 45877, July 26, 2000]



Sec.  522.460  Cloprostenol sodium.

    (a)(1) Specifications. Each milliliter of the aqueous solution 
contains 263 micrograms of cloprostenol sodium (equivalent to 250 
micrograms of cloprostenol) in a sodium citrate, anhydrous citric acid 
and sodium chloride buffer containing 0.1 percent w/v chlorocresol B.P. 
as a bactericide.
    (2) Sponsor. See No. 000061 in Sec.  510.600(c) of this chapter.
    (3) Conditions of use. For intramuscular use in beef and dairy 
cattle to induce luteolysis.
    (i) Amount. 2 milliliters (equivalent to 500 micrograms of 
cloprostenol).
    (ii) Indications. (a) For scheduling estrus and ovulation to control 
the time at which cycling cows or heifers can be bred.
    (1) Single cloprostenol injection. Treat only animals with a mature 
corpus luteum. Estrus should occur in 2 to 5 days, and cattle should be 
inseminated at the usual time relative to the detection of estrus. If 
estrus is not observed, treated animals may be inseminated either once 
at 72 hours post injection or twice at 72 and 96 hours post injection.
    (2) Double cloprostenol injection. Give cattle a second injection 11 
days after the first injection. Estrus should occur 2 to 5 days after 
the second injection, and cattle should be inseminated at the usual time 
relative to the detection of estrus. If estrus is not observed, treated 
animals may be inseminated either once at about 72 hours post injection 
or twice at 72 and 96 hours following the second injection.
    (b) Single cloprostenol injection for terminating unwanted 
pregnancies from mismatings from 1 week after mating until 5 months 
after conception, or for treating unobserved (nondetected) estrus, 
mummified fetus, and luteal cysts.
    (c) Single cloprostenol injection for the treatment of pyometra.
    (iii) Do not administer to pregnant animals where the calf is not to 
be aborted.
    (iv) Women of childbearing age, asthmatics, and persons with 
bronchial and other respiratory problems should exercise extreme caution 
when handling this product. Cloprostenol 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.
    (v) 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 131.5 micrograms of cloprostenol sodium (equivalent to 125 
micrograms of cloprostenol).
    (2) Sponsor. See No. 000061 in Sec.  510.600(c) of this chapter.
    (3) Special considerations. Labeling shall bear the statements 
prescribed in paragraphs (a)(3) (iii) and (iv) of this section.
    (4) Conditions of use--(i) Amount. 3 milliliters (equivalent to 375 
micrograms of cloprostenol) intramuscularly per animal as a single dose.
    (ii) Indications for use. To induce abortion in pregnant feedlot 
heifers from 1 week after mating until 4\1/2\ months of gestation.
    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

[47 FR 4678, Feb. 2, 1982, as amended at 48 FR 15619, Apr. 12, 1983; 49 
FR 5100, Feb. 10, 1984; 49 FR 29957, July 25, 1984; 65 FR 6892, Feb. 11, 
2000]



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

[[Page 228]]

sterile saline or sterile water for injection. The resulting solution 
contains colistimethate sodium equivalent to 133 milligrams per 
milliliter colistin activity.
    (b) Sponsor. See 046573 in Sec.  510.600(c) of this chapter.
    (c) [Reserved]
    (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]



Sec.  522.480  Repository corticotropin injection.

    (a)(1) Specifications. The drug conforms to repository corticotropin 
injection U.S.P. It contains 40 or 80 U.S.C. (I.U.) units per cubic 
centimeter.
    (2) Sponsor. See No. 037990 in Sec.  510.600(c) of this chapter.
    (3) Special considerations. The drug should be refrigerated. With 
prolonged use supplement daily diet with potassium chloride at one gram 
for small animals and from 5 to 10 grams for large animals.
    (4) Conditions of use. (i) It is used as an intramuscular or 
subcutaneous injection in cattle and small animals for stimulation of 
the adrenal cortex where there is a general deficiency of corticotropin 
(ACTH). It is also a therapeutic agent for primary bovine ketosis.
    (ii) It is administered to cattle initially at 200 to 600 units 
followed by a dose daily or every other day of 200 to 300 units and to 
small animals at one unit per pound of body weight to be repeated as 
indicated.
    (iii) For use only by or on the order of a licensed veterinarian.
    (b)(1) Specifications. The drug conforms to respository 
corticotropin injection U.S.P. It contains 40 or 80 U.S.P. units per 
milliliter.
    (2) Sponsor. See No. 000864 in Sec.  510.600(c) of this chapter.
    (3) Conditions of use. (i) For intramuscular injection in dogs as a 
diagnostic aid to test for adrenal dysfunction. For intramuscular or 
subcutaneous injection in dogs and cats for stimulation of the adrenal 
cortex where there is a general deficiency of ACTH.
    (ii) For diagnostic use: Administer at one unit per pound of body 
weight intramuscularly. For therapeutic use: Administer at one unit per 
pound of body weight intramuscularly or subcutaneously, initially, to be 
repeated as indicated.
    (iii) Federal law restricts this drug to use by or on the order of a 
licensed veterinarian.
    (c) National Academy of Sciences/National Reserach Council (NAS/NRC) 
status. The therapeutic indication for use has been reviewed by NAS/NRC 
and found to be effective. Applications for this use need not include 
effectiveness data as specified in Sec.  514.111 of this chapter, but 
may require bioequivalency and safety information.

[40 FR 13858, Mar. 27, 1985, as amended at 50 FR 40966, Oct. 8, 1985; 53 
FR 45760, Nov. 14, 1988]



Sec.  522.518  Cupric glycinate injection.

    (a) Specifications. Each milliliter (mL) of sterile aqueous 
suspension contains 200 milligrams of cupric glycinate (equivalent to 60 
milligrams of copper).
    (b) Sponsor. See No. 049185 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use--(1) Amount. 200 milligrams (1 mL) for calves 
300 pounds and under; 400 milligrams (2 mL) for calves over 300 pounds 
and adult cattle.
    (2) Indications for use. For beef calves and beef cattle for the 
prevention of copper deficiency, or when labeled for veterinary 
prescription use, for the prevention and/or treatment of copper 
deficiency alone or in association with molybdenum toxicity.
    (3) Limitations. For subcutaneous use only; repeat dose in 3 months 
in young

[[Page 229]]

calves, in 6 months in cattle; discontinue use 30 days before treated 
animals are slaughtered for food use; Federal law restricts this drug to 
use by or on the order of a licensed veterinarian.

[46 FR 20159, Apr. 3, 1981, as amended at 52 FR 7832, Mar. 13, 1987; 62 
FR 28630, May 27, 1997]



Sec.  522.522  Danofloxacin.

    (a) Specifications. Each milliliter of solution contains 180 
milligrams (mg) danofloxacin as the mesylate salt.
    (b) Sponsor. See No. 000069 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. 6 mg per kilogram of 
body weight by subcutaneous injection. Treatment should be repeated 
approximately 48 hours following the first injection.
    (2) Indications for use. For the treatment of bovine respiratory 
disease (BRD) associated with Mannheimia (Pasteurella) haemolytica and 
Pasteurella multocida.
    (3) 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]



Sec.  522.533  Deslorelin acetate.

    (a) Specifications. Each implant contains 2.1 milligrams deslorelin 
acetate.
    (b) Sponsor. See 064288 in Sec.  510.600(c) of this chapter.
    (c) [Reserved]
    (d) Conditions of use--(1) Horses and ponies--(i) Amount. One 
implant per mare.
    (ii) Indications for use. For inducing ovulation within 48 hours in 
estrous mares with an ovarian follicle greater than 30 millimiters in 
diameter. Follicular size should be determined by rectal palpation and/
or ultrasonography prior to treatment.
    (iii) Limitations. Administer subcutaneously in the neck. Not for 
use in horses or ponies intended for food. Federal law restricts this 
drug to use by or on the order of a licensed veterinarian.
    (2) [Reserved]

[63 FR 44383, Aug. 19, 1998]



Sec.  522.535  Desoxycorticosterone pivalate.

    (a) Specifications. Each milliliter of sterile aqueous suspension 
contains 25 milligrams of desoxycorticosterone pivalate.
    (b) Sponsor. See No. 058198 in Sec.  510.600(c) of this chapter.
    (c) [Reserved]
    (d) Conditions of use--(1) Dogs--(i) Amount. 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.
    (ii) Indications for use. For use as replacement therapy for the 
mineralocorticoid deficit in dogs with primary adrenocortical 
insufficiency.
    (iii) Limitations. For intramuscular use only. Do not use in 
pregnant dogs, dogs suffering from congestive heart disease, severe 
renal disease, or edema. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.
    (2) [Reserved]

[63 FR 13122, Mar. 18, 1998]



Sec.  522.536  Detomidine hydrochloride injection.

    (a) Specification. Each milliliter of sterile aqueous solution 
contains 10 milligrams of detomidine hydrochloride.
    (b) Sponsor. See 052483 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use--(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.

[[Page 230]]

    (2) Indication for use. As a sedative and analgesic to facilitate 
minor surgical and diagnostic procedures in mature horses and yearlings.
    (3) Limitations. For sedation administer intraveneously (IV) or 
intramuscularly (IM); for analgesia by IV; for both sedation and 
analgesia by IV. Do not use in horses with pre-existing atrioventricular 
or sinoauricular block, with severe coronary insufficiency, 
cerebrovascular disease, respiratory disease, or chronic renal failure. 
Do not use in breeding animals. Not for use in horses intended for food. 
Federal law restricts this drug to use by or on the order of a licensed 
veterinarian.

[54 FR 50365, Dec. 6, 1989; 54 FR 51551, Dec. 15, 1989]



Sec.  522.540  Dexamethasone injection.

    (a)(1) Specifications. The drug is a sterile aqueous solution. Each 
milliliter contains 2 mg of dexamethasone.
    (2) Sponsor. See Nos. 000061 and 059130 in Sec.  510.600(c) of this 
chapter.
    (3) Conditions of use. (i) The drug is indicated for the treatment 
of primary bovine ketosis and as an anti-inflammatory agent in dogs, 
cats, cattle, and horses.\1\
    (ii) The drug is administered intravenously or intramuscularly and 
dosage may be repeated if necessary, as follows: \1\
    (a) Canine--0.25 to 1 mg.
    (b) Feline--0.125 to 0.5 mg.
    (c) Equine--2.5 to 5 mg.
    (d) Bovine--5 to 20 mg depending on the severity of the condition.
    (iii) Clinical and experimental data have 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.
    (iv) Federal law restricts this drug to use by or on the order of a 
licensed veterinarian.
    (b)(1) Specifications. The drug is a sterile aqueous solution. Each 
milliliter contains either 2.0 milligrams of dexamethasone or 4.0 
milligrams of dexamethasone sodium phosphate (equivalent to 3.0 
milligrams dexamethasone).
    (2) Sponsor. See number in Sec.  510.600(c) of this chapter as 
follows:
    (i) No. 000864 for use of 2.0 milligrams dexamethasone or 4.0 
milligrams dexamethasone sodium phosphate injections.
    (ii) No. 000402 for use of 2.0 milligrams dexamethasone or 4.0 
milligrams dexamethasone sodium phosphate injections.
    (3) Conditions of use. (i) The drug is used 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. \1\
---------------------------------------------------------------------------

    \1\ These conditions are NAS/NRC-reviewed and deemed effective. 
Applications for these uses need not include effectiveness data as 
specified by Sec.  514.111 of this chapter, but may require 
bioequivalency and safety information.
---------------------------------------------------------------------------

    (ii) The drug is administered intravenously at 0.25 to 1 milligram 
initially. The dose may be repeated for 3 to 5 days or until a response 
is noted. If continued treatment is required, oral therapy may be 
substituted. When therapy is withdrawn after prolonged use, the daily 
dose should be reduced gradually over several days. \1\
    (iii) Clinical and experimental data have 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.
    (iv) Federal law restricts this drug to use by or on the order of a 
licensed veterinarian.
    (c)(1) Specifications. The drug is a sterile aqueous solution. Each 
milliliter contains 2.0 milligrams of dexamethasone or 4.0 milligrams of 
dexamethasone sodium phosphate (equivalent to 3.0 milligrams of 
dexamethasone).
    (2) Sponsor. See Nos. 000402 and 000864 in Sec.  510.600(c) of this 
chapter.
    (3) Conditions of use. (i) The drug is used as a rapid adrenal 
glucocorticoid

[[Page 231]]

and/or anti-inflammatory agent in horses. \1\
    (ii) The drug is administered intravenously at a dosage of 2.5 to 
5.0 milligrams. If permanent corticosteroid effect is required, oral 
therapy may be substituted. When therapy is withdrawn after prolonged 
use, the daily dose should be reduced gradually over several days. \1\
    (iii) Clinical and experimental data have 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.
    (iv) Not for use in horses intended for food.
    (v) Federal law restricts this drug to use by or on the order of a 
licensed veterinarian.
    (d)(1) Specifications. The drug is a sterile aqueous solution. Each 
milliliter contains 2.0 milligrams of dexamethasone or 4.0 milligrams of 
dexamethasone sodium phosphate (equivalent to 3.0 milligrams of 
dexamethasone).
    (2) Sponsors. See the following numbers in Sec.  510.600(c) of this 
chapter:
    (i) Nos. 000069 and 059130 for intravenous or intramuscular use of 
2.0 milligrams dexamethasone injection.
    (ii) No. 000069 for intravenous use of 2.0 milligrams dexamethasone 
injection.
    (3) Conditions of use. (i) The drug is used as an anti-inflammatory 
agent in dogs, cats, and horses.
    (ii) It is administered intravenously or intramuscularly as follows: 
dogs--0.25 to 1 milligram; cats--0.125 to 0.5 milligram; horses--2.5 to 
5 milligrams.
    (iii) Clinical and experimental data have demonstrated that 
corticosteroids administered orally or by injection 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.
    (iv) Not for use in horses intended for food.
    (v) Federal law restricts this drug to use by or on the order of a 
licensed veterinarian.
    (e)(1) Specifications. The drug is a sterile aqueous solution. Each 
milliliter contains 4.0 milligrams of dexamethasone sodium phosphate 
(equivalent to 3 milligrams of dexamethasone).
    (2) Sponsor. See No. 059130 in Sec.  510.600(c) of this chapter.
    (3) Conditions of use. (i) The drug is given for glucocorticoid and 
anti-inflammatory effect in dogs and horses.
    (ii) Administer intravenously as follows: Dogs--0.25 to 1 milligram 
initially; may be repeated for 3 to 5 days or until response is noted. 
Horses--2.5 to 5 milligrams. If permanent glucocorticoid effect is 
required, oral therapy may be substituted. When therapy is to be 
withdrawn after prolonged use, the daily dose should be reduced 
gradually over several days.
    (iii) Clinical and experimental data have demonstrated that 
corticosteroids administered orally or by injection 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.
    (iv) Do not use in viral infections. Anti-inflammatory action of 
corticosteroids may mask signs of infections. Except when used for 
emergency therapy, the product is contraindicated in animals with 
tuberculosis, chronic nephritis, cushingoid syndrome, or peptic ulcers.
    (v) Not for use in horses intended for food.
    (vi) 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 on GPO Access.



Sec.  522.542  Dexamethasone-21-isonicotinate suspension.

    (a) Specifications. Each milliliter of sterile suspension contains 1 
milligram of dexamethasone-21-isonicotinate.

[[Page 232]]

    (b) Sponsor. No. 000010 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use. (1) The drug is used in the treatment of 
various inflammatory conditions associated with the musculoskeletal 
system in dogs, cats, and horses.
    (2) It is recommended for intramuscular administration as follows: 
Dogs--0.25 to 1 milligram; cats--0.125 to 0.5 milligram; horses--5 to 20 
milligrams. Dosage may be repeated.
    (3) Clinical and experimental data have demonstrated that 
corticosteriods 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 
following by dystocia, fetal death, retained placenta, and metritis.
    (4) Not for use in horses intended for food.
    (5) Federal law restricts this drug to use by or on the order of a 
licensed veterinarian.

[42 FR 37543, July 22, 1977, as amended at 47 FR 14703, Apr. 6, 1982]



Sec.  522.563  Diatrizoate meglumine and diatrizoate sodium injection.

    (a) Specifications. Diatrizoate meglumine and diatrizoate sodium 
injection contains 34.3 percent diatrizoate meglumine and 35 percent 
diatrizoate sodium, or 66 percent diatrizoate meglumine and 10 percent 
diatrizoate sodium, in sterile aqueous solution.
    (b) Sponsor. See No. 053501 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use. (1) It is indicated for use in dogs and cats 
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. It is also useful as an aid 
in delineating peritoneal hernias and fistulous tracts.
    (2) For excretion urography administer 0.5 to 1.0 milliliter per 
pound of body weight to a maximum of 30 milliliters intravenously. For 
cystography remove urine, administer 5 to 25 milliliters directly into 
the bladder via catheter. For urethrography administer 1.0 to 5 
milliliters via catheter into the urethra to provide desired contrasts 
delineation. For angiocardiography (including aortography) rapidly 
inject 5 to 10 milliliters directly into the heart via catheter or 
intraventricular puncture. For cerebral angiography rapid injection of 3 
to 10 milliliters via carotid artery. For peripheral arteriography and/
or venography and selective coronary arteriography rapidly inject 3 to 
10 milliliters intravascularly into the vascular bed to be delineated. 
For lymphography slowly inject 1.0 to 10 milliliters directly into the 
lymph vessel to be delineated. For arthrography slowly inject 1.0 to 5 
milliliters directly into the joint to be delineated. For discography 
slowly inject 0.5 to 1.0 milliliter directly into the disc to be 
delineated. For sialography slowly inject 0.5 to 1.0 milliliter 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 milliliter per pound of body weight directly 
into the peritoneal cavity.
    (3) 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]



Sec.  522.575  Diazepam injection.

    (a) Specification. Each milliliter of sterile solution contains 5 
milligrams of diazepam.
    (b) Sponsor. See 063238 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use. Dogs--(1) Indications for use. As a 
preanesthetic agent to reduce the amount of barbiturate required for 
short duration anesthesia.
    (2) Dosage. Intravenously, 0.2 milligram per kilogram of body weight 
3-5 minutes before anesthesia is to be induced using a short acting 
barbiturate.
    (3) Limitations. Not for use in dogs with known sensitivity to 
benzodiazepines. Safety in animals intended for breeding and pregnant 
animals has not been established. Federal

[[Page 233]]

law restricts this drug to use by or on the order of a licensed 
veterinarian.

[58 FR 500, Jan. 6, 1993, as amended at 66 FR 46705, Sept. 7, 2001]



Sec.  522.650  Dihydrostreptomycin sulfate injection.

    (a) Specifications. Each milliliter contains dihydrostreptomycin 
sulfate equivalent to 500 milligrams of dihydrostreptomycin.
    (b) Sponsor. See Nos. 000069 and 055529 in Sec.  510.600(c) of this 
chapter.
    (c) National Academy of Sciences/National Research Council (NAS/NRC) 
status. The conditions of use were NAS/NRC reviewed and found effective. 
Applications for these uses need not include effectiveness data as 
specified by Sec.  514.111 of this chapter but may require 
bioequivalency and safety information.
    (d) Conditions of use--(1) Amount. 5 milligrams per pound of body 
weight every 12 hours.
    (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. Administer by deep intramuscular injection only. 
Treatment should be continued for 3 to 5 days or until the urine is free 
of leptospira for at least 72 hours as measured by darkfield microscopic 
examination. Treatment with subtherapeutic dosages, excessive duration 
of therapy, or inappropriate use of this antibiotic may lead to the 
emergence of streptomycin or dihydrostreptomycin resistant organisms. 
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]



Sec.  522.690  Dinoprost solution.

    (a) Specifications. Each milliliter (mL) of solution contains 
dinoprost tromethamine equivalent to 5 milligrams (mg) dinoprost.
    (b) Sponsors. See Nos. 000009 and 059130 in Sec.  510.600(c) of this 
chapter.
    (c) Special considerations. (1) Federal law restricts this drug to 
use by or on the order of a licensed veterinarian.
    (2) Women of child-bearing age, asthmatics, and persons with 
bronchial and other respiratory problems should exercise extreme caution 
when handling this product. Dinoprost tromethamine is readily absorbed 
through the skin and can cause abortion and bronchiospasms. Accidental 
spillage on the skin should be washed off immediately with soap and 
water.
    (d) Conditions of use--(1) Horses--(i) Amount. 1 mg per 100 pounds 
of body weight as a single intramuscular injection.
    (ii) Indications. 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. Not for use in horses intended for food.
    (2) Cattle--(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 solution as provided by No. 000009 in Sec.  510.600(c) 
of this chapter may be used concurrently with progesterone intravaginal 
inserts as in Sec.  529.1940 of this chapter.
    (3) Swine--(i) Amount. 10 mg as a single intramuscular injection.

[[Page 234]]

    (ii) Indications. For parturition induction in swine when injected 
within 3 days of normal predicted farrowing.

[67 FR 41824, June 20, 2002]



Sec.  522.723  Diprenorphine hydrochloride injection.

    (a) Chemical name. N-(Cyclopropyl-methyl)-6,7,8,14-tetrahydro-7-
alpha-(1-hydroxy - 1 - methylethyl) - 6,14 - endoethanonororipavine 
hydrochloride.
    (b) Specifications. Each milliliter of diprenorphine hydrochloride 
injection, veterinary, contains 2 mg of diprenorphine hydrochloride in 
sterile aqueous solution.
    (c) Sponsors. See No. 053923 in Sec.  510.600(c) of this chapter.
    (d) Conditions of use. (1) 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.
    (2) It is administered intramuscularly or intravenously at a 
suitable dosage level depending upon the species.
    (3) 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.
    (4) 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.

[40 FR 13858, Mar. 27, 1975, as amended at 48 FR 16241, Apr. 15, 1983; 
60 FR 39847, Aug. 4, 1995; 64 FR 15684, Apr. 1, 1999]



Sec.  522.770  Doramectin.

    (a) Specifications. Each milliliter of sterile aqueous solution 
contains 10 milligrams of doramectin.
    (b) Sponsor. See No. 000069 in Sec.  510.600 (c) of this chapter.
    (c) Related tolerances. See Sec.  556.225 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]



Sec.  522.775  Doxapram hydrochloride injection.

    (a) Specifications. The drug is a sterile aqueous solution 
containing 20 milligrams doxapram hydrochloride per milliliter.
    (b) Sponsor. See No. 000856 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use. (1) Administer to dogs, cats, and horses to 
stimulate respiration during and after general anesthesia; to speed 
awakening and return of reflexes after anesthesia. Administer to neonate 
dogs and cats to initiate respiration following dystocia or caesarean 
section; to stimulate respiration following dystocia or caesarean 
section.
    (2) For intravenous use in dogs and cats at a dose of 2\1/2\ to 5 
milligrams of doxapram hydrochloride per pound of body weight in 
barbiturate anesthesia, 0.5 mg per lb. in gas anesthesia; for 
intravenous use in horses at 0.25 mg per lb. of body weight in 
barbiturate anesthesia, 0.2 mg per lb. in inhalation anesthesia, 0.25 mg 
per lb. with chloral

[[Page 235]]

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

[40 FR 17838, Apr. 23, 1975, as amended at 67 FR 67521, Nov. 6, 2002]



Sec.  522.778  Doxycycline hyclate.

    (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 000009 in Sec.  510.600(c) of this chapter.
    (c) [Reserved]
    (d) Conditions of use--(1) Dogs--(i) Amount. Apply subgingivally to 
periodontal pocket(s) of affected teeth.
    (ii) Indications for use. For treatment and control of periodontal 
disease.
    (iii) Limitations. Do not use in dogs less than 1-year old. Use of 
tetracyclines during tooth development has been associated with 
permanent discoloration of teeth. Do not use in pregnant bitches. Use in 
breeding dogs has not been evaluated. Federal law restricts this drug to 
use by or on the order of a licensed veterinarian.

[63 FR 8349, Feb. 19, 1998, as amended at 65 FR 45878, July 26, 2000]



Sec.  522.784  Doxylamine succinate injection.

    (a) Specifications. Each milliliter of the drug contains 11.36 mg of 
doxylamine succinate.
    (b) Sponsor. See No. 000061 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use. (1) The drug is used in conditions in which 
antihistaminic therapy may be expected to alleviate some signs of 
disease in horses, dogs, and cats. \1\
---------------------------------------------------------------------------

    \1\ These conditions are NAS/NRC reviewed and deemed effective. 
Applications for these uses need not include effectiveness data as 
specified by Sec.  514.111 of this chapter.
---------------------------------------------------------------------------

    (2) It is administered to horses at a dosage level of 25 mg per 
hundred pounds of body weight. It is administered to dogs and cats at a 
dosage level of 0.5 to 1 mg per pound of body weight. Doses may be 
repeated at 8 to 12 hours, if necessary, to produce desired effect. 
Intravenous route is not recommended for dogs and cats and should be 
injected slowly in horses. Intramuscular and subcutaneous administration 
should be by divided injection sites. \1\
    (3) Not for use in horses intended for food. \1\
    (4) Federal law restricts this drug to use by or on the order of a 
licensed veterinarian. \1\

[40 FR 13858, 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 61625, Nov. 
19, 1997]



Sec.  522.800  Droperidol and fentanyl citrate injection.

    (a) Specifications. Droperidol and fentanyl citrate injection is a 
sterile solution containing 20 milligrams of droperidol and 0.4 
milligram of fentanyl citrate per cubic centimeter.
    (b) Sponsor. See No. 000061 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use. (1) It is used in dogs as an analgesic and 
tranquilizer and for general anesthesia.
    (2) It is administered as follows:
    (i) For analgesia and tranquilization administer according to 
response desired, as follows:
    (a) Intramuscularly at the rate of 1 cubic centimeter per 15 to 20 
pounds of body weight in conjunction with atropine sulfate administered 
at the rate of 0.02 milligram per pound of body weight, or
    (b) Intravenously at the rate of 1 cubic centimeter per 25 to 60 
pounds of body weight in conjunction with atropine sulfate administered 
at the rate of 0.02 milligram per pound of body weight.
    (ii) For general anesthesia administer according to response 
desired, as follows:
    (a) Intramuscularly at the rate of 1 cubic centimeter per 40 pounds 
of body weight in conjunction with atropine sulfate administered at the 
rate of 0.02 milligram per pound of body weight

[[Page 236]]

and followed in 10 minutes by an intravenous administration of sodium 
pentobarbital at the rate of 3 milligrams per pound of body weight, or
    (b) Intravenously at the rate of 1 cubic centimeter per 25 to 60 
pounds of body weight in conjunction with atropine sulfate administered 
at the rate of 0.02 milligram per pound of body weight and followed 
within 15 seconds by an intravenous administration of sodium 
pentobarbital at the rate of 3 milligrams per pound of body weight.
    (3) For use only by or on the order of a licensed veterinarian.

[40 FR 13858, Mar. 27, 1975, as amended at 64 FR 15684, Apr. 1, 1999]



Sec.  522.812  Enrofloxacin solution.

    (a) Specifications. Each milliliter of sterile solution contains 
either 22.7 milligrams of enrofloxacin when intended for use in dogs or 
100 milligrams of enrofloxacin when intended for use in cattle.
    (b) Sponsor. See No. 000859 in Sec.  510.600(c) of this chapter.
    (c) Related tolerance. See Sec.  556.228 of this chapter.
    (d) Conditions of use--(1) Dogs--(i) Amount. 2.5 milligrams per 
kilogram (1.13 milligrams per pound) of body weight as an initial dose 
only.
    (ii) Indications for use. Dogs for management of diseases associated 
with bacteria susceptible to enrofloxacin.
    (iii) Limitations. 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. Federal law restricts this drug 
to use by or on the order of a licensed veterinarian.
    (2) Cattle--(i) Amount. Single-dose therapy: 7.5 to 12.5 milligrams 
enrofloxacin per kilogram of body weight (3.4 to 5.7 milliliters per 100 
pounds). Multiple-day therapy: 2.5 to 5.0 milligrams per kilogram of 
body weight (1.1 to 2.3 milliliters per 100 pounds) administered once 
daily for 3 to 5 days.
    (ii) Indications for use. For the treatment of bovine respiratory 
disease (BRD) associated with Pasteurella haemolytica, P. multocida, and 
Haemophilus somnus.
    (iii) Limitations. For subcutaneous use in cattle only. Do not 
inject more than 20 milliliters at each site. Do not slaughter within 28 
days of 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. The effect of enrofloxacin on bovine reproductive performance, 
pregnancy, and lactation have not been determined. 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.

[55 FR 26683, June 29, 1990, as amended at 62 FR 38907, July 21, 1997; 
63 FR 49003, Sept. 14, 1998]



Sec.  522.820  Erythromycin injection.

    (a) Sponsor. See 061623 in Sec.  510.600(c) of this chapter.
    (b) NAS/NRC status. The conditions of use have been reviewed by NAS/
NRC and found effective.
    (c) Dogs and cats--(1) Specifications. Each milliliter of 
polyethylene glycol vehicle contains 100 milligrams of erythromycin base 
with 2 percent butyl aminobenzoate.
    (2) Conditions of use--(i) Amount. 3 to 5 milligrams per pound of 
body weight, intramuscularly, two to three times daily, for up to 5 
days.
    (ii) Indications for use--(A) Dogs. 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.
    (B) Cats. 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. Administer by deep intramuscular injection into 
the heavy muscles of the neck and limbs. Do not administer intravenously 
or intraperitoneally. Avoid subscutaneous use. Do not administer from 
moist or

[[Page 237]]

wet syringe. As with all antibiotics, appropriate in vitro culturing and 
susceptibility testing of samples taken before treatment should be 
conducted. Do not administer in conjunction with penicillin. As with all 
antibiotics, excessive continuous use may result in an overgrowth of 
nonsusceptible organisms. Federal law restricts this drug to use by or 
on the order of a licensed veterinarian.
    (d) Cattle.--(1) Specifications. Each milliliter of nonaqueous, 
buffered, alcohol base sterile solution contains 200 milligrams of 
erythromycin base.
    (2) Related tolerances. See Sec.  556.230 of this chapter.
    (3) Conditions of use--(i) Amount. 4 milligrams of erythromycin base 
per pound of body weight 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. For intramuscular use only. Do not use in female 
dairy cattle over 20 months of age. Do not slaughter treated animals 
within 6 days of last treatment. To avoid excess trim, do not slaughter 
within 21 days of last injection.

[58 FR 43795, Aug. 18, 1993, as amended at 66 FR 14073, Mar. 9, 2001; 68 
FR 4915, Jan. 31, 2003]



Sec.  522.840  Estradiol.

    (a) Specifications. Each silicone rubber implant contains 25.7 or 
43.9 milligrams of estradiol.
    (b) Sponsor. See No. 021641 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use. It is used for implantation in steers and 
heifers as follows:
    (1) Amount. Insert one 25.7-milligram implant every 200 days; insert 
one 43.9-milligram 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.
    (3) Limitations. For subcutaneous ear implantation in steers and 
heifers only. A second implant may be used if desired. No additional 
effectiveness may be expected from reimplanting in less than 200 days 
for the 25.7-milligram implant or 400 days for the 43.9 milligram 
implant. Increased sexual activity (bulling, riding, and excitability) 
has been reported in implanted animals.

[51 FR 22276, June 19, 1986, as amended at 57 FR 41861, Sept. 14, 1992; 
66 FR 56035, Nov. 6, 2001]



Sec.  522.842  Estradiol benzoate and testosterone propionate in combination.

    (a) [Reserved]
    (b) Sponsors. See 000856 in Sec.  510.600(c) of this chapter for use 
as in paragraph (d)(1)(i), (d)(2), and (d)(3) of this section. See 
021641 in Sec.  510.600(c) of this chapter for use as in paragraph (d) 
of this section.
    (c) Related tolerances. See Sec. Sec.  556.240 and 556.710 of this 
chapter.
    (d) Conditions of use--Heifers. For implantation as follows:
    (1) Amount. (i) 20 milligrams of estradiol benzoate and 200 
milligrams of testosterone propionate per dose.
    (ii) 20 milligrams estradiol benzoate and 200 milligrams 
testosterone propionate in eight pellets with 29 milligrams tylosin 
tartrate as a local antibacterial in one pellet, per implant dose.
    (2) Indications for use. Growth promotion 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.

[40 FR 13858, Mar. 27, 1975, as amended at 49 FR 29778, July 24, 1984; 
61 FR 5506, Feb. 13, 1996; 64 FR 48294, Sept. 3, 1999]



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 050604 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use--(1) Amount. One implant and 2 milliliters of 
injection at time of implantation.

[[Page 238]]

    (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]



Sec.  522.863  Ethylisobutrazine hydrochloride injection.

    (a) Specifications. The drug is a sterile aqueous solution. Each 
milliliter contains 50 milligrams of ethylisobutrazine hydrochloride.
    (b) Sponsor. See No. 000061 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use. (1) It is used in dogs as a tranquilizer.\1\
    (2) It is administered intramuscularly at a dosage level of 2 to 5 
milligrams of ethylisobutrazine hydrochloride per pound of body weight 
for profound tranquilization. It is administered intravenously at a 
dosage level of 1 to 2 milligrams of ethylisobutrazine hydrochloride per 
pound of body weight to effect.\1\
---------------------------------------------------------------------------

    \1\ These conditions are NAS/NRC reviewed and deemed effective. 
Applications for these uses need not include effectiveness data as 
specified by Sec.  514.111 of this chapter, but may require 
bioequivalency and safety information.
---------------------------------------------------------------------------

    (3) It is not to be used in conjunction with organophosphates and/or 
procaine hydrochloride because phenothiazines may potentiate the 
toxicity of organophosphates and the activity of procaine 
hydrochloride.\1\
    (4) Federal law restricts this drug to use by or on the order of a 
licensed veterinarian.\1\

[40 FR 13858, Mar. 27, 1975, as amended at 46 FR 48642, Oct. 2, 1981; 61 
FR 8873, Mar. 6, 1996; 62 FR 61625, Nov. 19, 1997]



Sec.  522.883  Etorphine hydrochloride injection.

    (a) Chemical name. 6,7,8,14 - tetrahydro - alpha - methyl - alpha - 
propyl - 6,14 - endo-ethenooripavine-alpha-methanol hydrochloride.
    (b) Specifications. Each milliliter of etorphine hydrochloride 
injection, veterinary, contains 1 mg of etorphine hydrochloride in 
sterile aqueous solution.
    (c) Sponsors. See No. 053923 in Sec.  510.600(c) of this chapter.
    (d) Conditions of use. (1) The drug is used for the immobilization 
of wild and exotic animals.
    (2) It is administered intramuscularly by hand syringe or syringe 
dart at a suitable dosage level depending upon the species.
    (3) Do not use the drug unless diprenorphine hydrochloride 
injection, veterinary, as provided for in Sec.  522.723, is available 
for use in reversing the effects of etorphine hydrochloride injection, 
veterinary.
    (4) 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.
    (5) 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.

[40 FR 13858, Mar. 27, 1975, as amended at 48 FR 16241, Apr. 15, 1983; 
61 FR 260, Jan. 4, 1996]



Sec.  522.900  Euthanasia solution.

    (a) [Reserved]
    (b)(1) Specifications. Each milliliter of nonsterile solution 
contains 390 milligrams of pentobarbital sodium and 50 milligrams of 
phenytoin sodium.

[[Page 239]]

    (2) Sponsor. Nos. 000061 and 059079 in Sec.  510.600(c) of this 
chapter.
    (3) Conditions of use--(i) Indications for use. For the humane, 
painless, and rapid euthanasia of dogs.
    (ii) Amount. One milliliter (390 milligrams of pentobarbital sodium 
and 50 milligrams of phenytoin sodium) for each 10 pounds of body 
weight.
    (iii) Limitations. For intravenous injection or intracardiac 
injection when intravenous use is impractical. Do not use for 
therapeutic purposes. Do not use in animals intended for food. Federal 
law restricts this drug to use by or on the order of a licensed 
veterinarian.
    (c)(1) Specifications. Each milliliter of nonsterile, aqueous 
solution contains 400 milligrams of secobarbital sodium and 25 
milligrams of dibucaine hydrochloride.
    (2) Sponsor. See 000033 in Sec.  510.600(c) of this chapter.
    (3) Conditions of use--(i) Indications for use. To induce rapid, 
humane, painless euthanasia of dogs.
    (ii) Amount. For dogs, 1 milliliter for each 10 pounds of body 
weight.
    (iii) Limitations. For intravenous injection. Do not use for 
therapeutic purposes. Do not use in animals intended for food. Federal 
law restricts this drug to use by or on the order of a licensed 
veterinarian.

[46 FR 23232, Apr. 24, 1981, as amended at 47 FR 15327, Apr. 9, 1982; 48 
FR 16241, Apr. 15, 1983; 52 FR 7832, Mar. 13, 1987; 56 FR 9623, Mar. 7, 
1991; 59 FR 14367, Mar. 28, 1994]



Sec.  522.914  Fenprostalene solution.

    (a) Specifications--(1) Cattle. Each milliliter of sterile solution 
contains 0.5 milligram of fenprostalene.
    (2) Swine. Each milliliter of sterile solution contains 0.25 
milligram of fenprostalene.
    (b) Sponsor. See 000856 in Sec.  510.600(c) of this chapter.
    (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) Amount. 1 milligram (2 
milliliters) subcutaneously per animal.
    (ii) Indications for use. For feedlot heifers to induce abortion 
when pregnant 150 days or less. For beef or nonlactating dairy cattle 
for estrus synchronization.
    (iii) Limitations. Subcutaneous use in cattle only. Feedlot heifers 
to induce abortion, single dose. Beef or nonlactating dairy cattle for 
estrus synchronization, a single dose or two doses 11 to 13 days apart. 
Do not use in pregnant animals unless abortion is desired. Federal law 
restricts this drug to use by or on the order of a licensed 
veterinarian.
    (2) Swine--(i) Amount. 0.25 milligram (1 milliliter) subcutaneously 
once per animal.
    (ii) Indications for use. For sows and gilts pregnant at least 112 
days for the induction of parturition.
    (iii) Limitations. Subcutaneous use in swine only. Federal law 
restricts this drug to use by or on the order of a licensed 
veterinarian.

[48 FR 7164, Feb. 18, 1983, as amended at 49 FR 26715, June 29, 1984; 54 
FR 400, Jan. 6, 1989; 61 FR 5506, Feb. 13, 1996]



Sec.  522.940  Colloidal ferric oxide injection.

    (a) Specifications. Each milliliter of the drug contains colloidal 
ferric oxide equivalent to 100 milligrams of iron stabilized with a low-
viscosity dextrin and contains 0.5 percent phenol as a preservative.
    (b) NAS/NRC status. Use of this drug has been NAS/NRC reviewed and 
found effective. Applications for these uses need not include 
effectiveness data as specified by Sec.  514.111 of this chapter, but 
may require bioequivalency and safety information.
    (c)(1) Sponsor. See Nos. 017800 and 053501 in Sec.  510.600(c) of 
this chapter.
    (2) Conditions of use. It is used in baby pigs as follows:
    (i) For the prevention of anemia due to iron deficiency, administer 
an initial intramuscular injection of 1 milliliter of the drug to each 
animal at any

[[Page 240]]

time between 2 to 5 days of age. Dosage may be repeated at 2 weeks of 
age.
    (ii) For the treatment of anemia due to iron deficiency, administer 
an intramuscular injection of from 1 to 2 milliliters of the drug to 
each animal at any time between 5 to 28 days of age.

[40 FR 13858, Mar. 27, 1975, as amended at 49 FR 38938, Oct. 2, 1984; 50 
FR 23298, June 3, 1985; 50 FR 25216, June 18, 1985; 51 FR 14989, Apr. 
22, 1986; 51 FR 18314, May 19, 1986; 67 FR 78355, Dec. 24, 2002]



Sec.  522.955  Florfenicol.

    (a) Specifications. Each milliliter of solution contains 300 
milligrams (mg) of florfenicol.
    (b) Sponsor. See 000061 in Sec.  510.600(c) of this chapter.
    (c) Related tolerance. See Sec.  556.283 of this chapter.
    (d) Conditions of use--(1) Cattle--(i) Amount. 20 mg per kilogram (/
kg) of body weight as an intramuscular injection. A second dose should 
be administered 48 hours later.
    (A) Indications for use. For treatment of bovine respiratory disease 
(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 andBacteroides 
melaninogenicus.
    (B) [Reserved]
    (ii) Amount. 40 mg/kg body weight as a single subcutaneous 
injection.
    (A) Indications for use. As in paragraph (d)(1)(i)(A) of this 
section; for control of respiratory disease in cattle at high risk of 
developing BRD associated with M. (Pasteurella) haemolytica, P. 
multocida, and H. somnus.
    (B) [Reserved]
    (iii) Limitations. Do not slaughter within 28 days of last 
intramuscular treatment or within 38 days of subcutaneous treatment. Do 
not use in female dairy cattle 20 months of age or older. Use 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.
    (2) [Reserved]

[61 FR 42383, Aug. 15, 1996, as amended at 63 FR 26981, May 15, 1998; 63 
FR 41191, Aug. 3, 1998; 64 FR 5596, Feb. 4, 1999; 64 FR 9435, Feb. 26, 
1999; 67 FR 6866, Feb. 14, 2002]



Sec.  522.960  Flumethasone implantation or injectable dosage forms.



Sec.  522.960a  Flumethasone suspension.

    (a) Chemical name. 6[alpha],9[alpha]-Difluoro-11[beta],17,21 - 
trihydroxy - 16[alpha] - methylpregna - 1,4 - diene - 3,20 - dione.
    (b) Specifications. Flumethasone suspension is sterile and each 
milliliter of the drug contains: 2 milligrams of flumethasone, 20 
milligrams of propylene glycol, 9 milligrams of benzyl alcohol (as 
preservative), 8 milligrams of sodium chloride, 0.02 milligram of 
polysorbate-80, 0.1 milligram of citric acid, and water for injection 
q.s.
    (c) Sponsor. See No. 000856 in Sec.  510.600(c) of this chapter.
    (d) Conditions of use. (1) It is recommended 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.
    (2) The drug is administered intraarticularly at a dosage level of 6 
to 10 milligrams per injection. The dosage level is dependent upon the 
size of the involved synovial structure and the degree of severity of 
the condition under treatment. The dosage is limited to a single 
injection per week in any one synovial structure.
    (3) Clinical and experimental data have demonstrated that 
corticosteroids administered orally and parenterally to animals during 
the last trimester of pregnancy may induce the first stage of 
parturition and may precipitate premature parturition followed by 
dystocia, fetal death, retained placenta, and metritis. The drug is not 
to be used in horses intended for slaughter for food purposes.
    (4) For use only by or on the order of a licensed veterinarian.

[40 FR 13858, Mar. 27, 1975. Redesignated at 44 FR 16011, Mar. 16, 1979, 
as amended at 61 FR 5506, Feb. 13, 1996]

[[Page 241]]



Sec.  522.960b  Flumethasone acetate injection.

    (a) Chemical name. 6-alpha,9-alpha-difluoro - 16 - alpha - 
methylprednisolone 21-acetate.
    (b) Specifications. Flumethasone injection is sterile and contains 
per cubic centimeter: 2 milligrams of flumethasone acetate; 20 
milligrams of propylene glycol; 9 milligrams of benzyl alcohol (as 
preservative); 8 milligrams of sodium chloride; 1 milligram of 
polysorbate 80; 0.1 milligram of citric acid; water for injection q.s.
    (c) Sponsor. See No. 000856 in Sec.  510.600(c) of this chapter.
    (d) Conditions of use. (1) It is recommended in certain acute and 
chronic canine dermatoses of varying etiology to help control the 
pruritus, irritation, and inflammation associated with these conditions.
    (2) The drug is administered intramuscularly at the following 
recommended daily dosage:

------------------------------------------------------------------------
                                                               Dosage in
                 Weight of animal in pounds                   milligrams
------------------------------------------------------------------------
Up to 10....................................................         1.0
10 to 25....................................................         2.0
25 and over.................................................         4.0
------------------------------------------------------------------------


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 milligram 
per animal.
    (3) For use only by or on the order of a licensed veterinarian.

[40 FR 13858, Mar. 27, 1975. Redesignated at 44 FR 16011, Mar. 16, 1979, 
as amended at 61 FR 5507, Feb. 13, 1996]



Sec.  522.960c  Flumethasone solution.

    (a) Specifications. Each milliliter of sterile aqueous solution 
contains 0.5 milligram flumethasone.
    (b) Sponsor. See No. 000856 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use. It is used as follows:
    (1) Horses--(i) Amount. 1.25 to 2.5 milligrams daily, intravenously, 
intramuscularly, or intra-articularly.
    (ii) Indications for use. It is used for 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--(a) Clinical and experimental data have 
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.
    (b) When a long-term therapy is used, the dose should be 
individually adjusted to the minimum maintenance dose. A protein-rich 
diet is useful in dogs and cats on long-term therapy to counteract 
nitrogen loss if it should occur. A small amount of potassium chloride 
daily in the diet will counteract excessive potassium loss if this is 
present.
    (c) It has been demonstrated that corticosteroids, especially at 
high dose levels, may result in delayed wound and fracture healing.
    (d) Flumethasone may be administered to animals with bacterial 
diseases provided appropriate antibacterial therapy is administered 
simultaneously.
    (e) The drug is not to be used in horses intended for slaughter for 
food purposes.
    (f) Federal law restricts this drug to use by or on the order of a 
licensed veterinarian.
    (2) Dogs--(i) Amount. 0.0625 to 0.25 milligram daily, intravenously, 
intramuscularly, or subcutaneously; 0.125 to 1.0 milligram daily, 
intralesionally, depending on the size and location of the lesion; 0.166 
to 1.0 milligram daily, intra-articularly, depending on the severity of 
the condition and the size of the involved joint.
    (ii) Indications for use. It is used for the treatment of 
musculoskeletal conditions due to inflamation 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

[[Page 242]]

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. See paragraph (c)(1)(iii) of this section.
    (3) Cats--(i) Amount. 0.03125 to 0.125 milligram daily 
intravenously, intramuscularly, or subcutaneously.
    (ii) Indications for use. It is used for the treatment of certain 
acute and chronic dermatoses of varying etiology to help control 
associated pruritus, irritation, and inflammation.
    (iii) Limitations. See paragraph (c)(1)(iii) of this section.

[44 FR 16011, Mar. 16, 1978, as amended at 61 FR 5507, Feb. 13, 1996]



Sec.  522.970  Flunixin meglumine solution.

    (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 and 059130 for use as in paragraph (e) of this 
section.
    (2) See Nos. 000856 and 057561 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. Not for use in horses intended for food.
    (2) Beef cattle and nonlactating dairy cattle-- (i) Amount. 1.1 to 
2.2 mg/kilogram (0.5 to 1.0 mg/lb) of body weight per day, as a single 
dose or divided into 2 doses administered at 12-hour intervals, 
intravenously, for up to 3 days.
    (ii) Indications for use. For control of pyrexia associated with 
bovine respiratory disease and endotoxemia. Also indicated for control 
of inflammation in endotoxemia.
    (iii) Limitations. Do not slaughter for food use within 4 days of 
last treatment. Not for use in lactating or 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.

[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]



Sec.  522.995  Fluprostenol sodium injection.

    (a) Specifications. Each milliliter of sterile aqueous solution 
contains fluprostenol sodium equivalent to 50 micrograms of 
fluprostenol.
    (b) Sponsor. See 000859 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use--(1) Amount. 0.55 microgram fluprostenol per 
kilogram of body weight.
    (2) Indications for use. The drug is used 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. Administer by intramuscular injection only. 
Warning: Not for use in horses intended for food. For veterinary use 
only. Federal law restricts this drug to use by or on the order of a 
licensed veterinarian. 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. Fluprostenol 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.

[44 FR 52191, Sept. 7, 1979, as amended at 47 FR 22092, May 21, 1982]

[[Page 243]]



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 059521 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. The drug is a lyophilized pituitary extract 
material. Each 10-milliliter vial contains an amount equivalent to 50 
milligrams of standard porcine follicle stimulating hormone and is 
reconstituted for use by addition of 10 milliliters of 0.9 percent 
aqueous sodium chloride solution.
    (2) Sponsor. See 063112 in Sec.  510.600(c) of this chapter.
    (3) Conditions of use. (i) Dosage. Cattle and horses, 10-50 
milligrams; sheep and swine, 5-25 milligrams; dogs, 5-15 milligrams.
    (ii) Indications for use. The drug is used as a supplemental source 
of follicle stimulating hormone where there is a general deficiency in 
cattle, horses, sheep, swine, and dogs.
    (iii) Limitations. Administer intramuscularly, subcutaneously, or 
intravenously. 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]



Sec.  522.1004  Fomepizole.

    (a) Specifications. Two vials, one containing 1.5 grams fomepizole 
(1.5 milliliter of 1.0 gram fomepizole per milliliter sterile aqueous 
solution), and one vial containing 30 milliliters of 0.9 percent sodium 
chloride injection USP (as a diluent).
    (b) Sponsor. See 062161 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use in dogs--(1) Amount. 20 milligrams per 
kilogram initially, 15 milligrams per kilogram at 12 and 24 hours, and 5 
milligrams per kilogram at 36 hours.
    (2) Indications for use. As an antidote for ethylene glycol 
(antifreeze) poisoning in dogs who have ingested or are suspected of 
having ingested ethylene glycol.
    (3) Limitations. Administer intravenously. For use by or on the 
order of a licensed veterinarian.

[61 FR 68147, Dec. 27, 1996]



Sec.  522.1010  Furosemide.

    (a) Specifications. Each milliliter of solution contains 50 
milligrams (mg) of furosemide diethanolamine.
    (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 as in paragraphs (d)(1) and (d)(2)(ii) of 
this section.
    (2) No. 000864 for use as in paragraph (d)(2)(ii) of this section.
    (3) Nos. 057926 and 059130 for use as in paragraphs (d)(1), 
(d)(2)(i), 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 food.
    (ii) Amount. 0.5 mg/lb body weight once or twice daily, 
intramuscularly or intravenously.

[[Page 244]]

    (A) Indications for use. For treatment of acute noninflammatory 
tissue edema.
    (B) Limitations. Do not use in horses intended for food.
    (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]



Sec.  522.1020  Gelatin solution.

    (a) Specifications. It is sterile and each 100 cubic centimeters 
contains 8 grams of gelatin in an 0.85 percent sodium chloride solution.
    (b) Sponsor. See No. 000856 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use. (1) It is used to restore circulatory volume 
and maintain blood pressure in animals being treated for shock.
    (2) 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. It 
is administered intravenously at a rate of 10 cubic centimeters per 
minute in small animals and 20 to 30 cubic centimeters per minute in 
large animals. The solution is administered aseptically and must be 
between 50 to 70 [deg]F. when injected.
    (3) A few animals will exhibit signs of allergic reaction. This 
solution can cause transient reversible nephrosis. This product is not 
intended to replace whole blood in cases of anemia and should not be 
used in the presence of renal dysfunction. Unused portions remaining in 
bottles should be discarded.
    (4) For use only by or on the order of a licensed veterinarian.



Sec.  522.1044  Gentamicin sulfate injection.

    (a) Specifications. Each milliliter of sterile aqueous solution 
contains gentamicin sulfate equivalent to either 5, 50, or 100 
milligrams of gentamicin.
    (b) Sponsors. (1) See No. 000061 in Sec.  510.600(c) of this chapter 
for use of: 5-milligrams-per-milliliter solution in swine as in 
paragraph (d)(4) of this section, 50-milligrams-per-milliliter solution 
in dogs and cats as in paragraph (d)(1) of this section, 50- and 100-
milligrams-per-milliliter solution in chickens and turkeys as in 
paragraphs (d)(2) and (d)(3) of this section.
    (2) [Reserved]
    (3) See No. 000010 for use of 50 milligrams-per-milliliter solution 
in dogs as in paragraph (d)(5) of this section.
    (4) See No. 059130 for use of 100 milligram-per-milliliter solution 
in turkeys as in paragraph (d)(2) of this section 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

[[Page 245]]

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 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]



Sec.  522.1055  Gleptoferron injection.

    (a) Specifications. Each milliliter contains the equivalent of 200 
milligrams of elemental iron as gleptoferron (complex of ferric 
hydroxide and dextran glucoheptonic acid), and 0.5 percent phenol as a 
preservative.
    (b) Sponsor. See 062408 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use. It is used in baby pigs as follows:
    (1) For prevention of iron deficiency anemia, administer 200 
milligrams of elemental iron intramuscularly on or before 3 days of age.
    (2) For treatment of iron deficiency anemia, administer 200 
milligrams of elemental iron intramuscularly.

[45 FR 61288, Sept. 16, 1980, as amended at 61 FR 18672, Apr. 29, 1996]



Sec.  522.1066  Glycopyrrolate injection.

    (a) Specifications. Each milliliter of aqueous solution contains 0.2 
milligram of glycopyrrolate.
    (b) Sponsor. See No. 000856 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use. (1) It is indicated as a preanesthetic agent 
in dogs and cats.
    (2) It is administered intravenously, intramuscularly, or 
subcutaneously in dogs and intramuscularly in cats at a dosage level of 
5 micrograms per pound of body weight (0.25 milliliter per 10 pounds of 
body weight).
    (3) Federal law restricts this drug to use by or on the order of a 
licensed veterinarian.

[48 FR 21567, May 13, 1983, as amended at 67 FR 67521, Nov. 6, 2002]

[[Page 246]]



Sec.  522.1077  Gonadorelin injectable.

    (a) Specifications. Each milliliter sterile aqueous solution 
contains 50 micrograms of gonadorelin (as hydrochloride).
    (b) Sponsor. See No. 000856 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use in cattle--(1) Amount. 100 micrograms per cow 
intramuscularly.
    (2) Indications for use. For the treatment of cystic ovaries 
(ovarian follicular cysts) in cattle to reduce the time to first estrus.
    (3) Limitations. For intramuscular use only. Federal law restricts 
this drug to use by or on the order of a licensed veterinarian.

[54 FR 50235, Dec. 5, 1989]



Sec.  522.1078  Gonadorelin diacetate tetrahydrate.

    (a) Specifications. Each milliliter of solution contains 50 
micrograms ([micro]g) of gonadorelin diacetate tetrahydrate.
    (b) Sponsors. See Nos. 050604, 057926, and 059130 in Sec.  
510.600(c) of this chapter.
    (c) Conditions of use in cattle. It is used as follows:
    (1) Amount. 100 [micro]g per cow as a single intramuscular or 
intravenous injection.
    (2) Indications for use. For the treatment of ovarian cysts in dairy 
cattle.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[67 FR 68759, Nov. 13, 2002]



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. 057926 in Sec.  510.600(c) of this chapter.
    (c) 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]



Sec.  522.1081  Chorionic gonadotropin for injection; chorionic gonadotropin suspension.

    (a)(1) Specifications. Chorionic gonadotropin for injection is 
supplied in vials containing 5,000, 10,000 or 20,000 U.S.P. units of 
lyophilized powder for reconstitution with the accompanying sterile 
diluent to a 10 milliliter solution.
    (2) Sponsor. See sponsor numbers in Sec.  510.600(c) of this 
chapter, as follows:
    (i) Nos. 000402 and 053501 for use of 10,000 U.S.P. units 
intramuscularly, 2,500 to 5,000 U.S.P. units intravenously, and 500 to 
2,500 U.S.P. units intrafollicularly in cattle.
    (ii) Nos. 058639 and 063323 for use of 10,000 U.S.P. units 
intramuscularly and 500 to 2,500 U.S.P. units intrafollicularly in 
cattle.
    (iii) No. 057926 for use of 10,000 U.S.P. units intramuscularly in 
cattle and finfish.
    (3) Related tolerances. See Sec.  556.304 of this chapter.
    (4) Conditions of use in cattle--(i) Amount. 10,000 USP units as a 
single, deep intramuscular injection; 500 to 2,500 USP units for 
intrafollicular injection; 2,500 to 5,000 USP units intravenously.
    (b) 500 to 2,500 U.S.P. units for intrafollicular injection.
    (c) 2,500 to 5,000 U.S.P. units intravenously.

[[Page 247]]

    (ii) Indications for use. For parenteral use in cows for treatment 
of nymphomania (frequent or constant heat) due to cystic ovaries.
    (iii) Limitations. Dosage may be repeated in 14 days if the animal's 
behavior or rectal examination of the ovaries indicates the necessity 
for retreatment. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.
    (5) Conditions of use in finfish--(i) Amount. 50 to 510 I.U. per 
pound of body weight for males, 67 to 1816 I.U. per pound of body weight 
for females, by intramuscular injection.
    (ii) Indications for use. An aid in improving spawning function in 
male and female brood finfish.
    (iii) Limitations. May administer up to three doses. The total dose 
administered per fish (all injections combined) should not exceed 25,000 
I.U. chorionic gonadotropin (25 milliliters) in fish intended for human 
consumption. Federal law restricts this drug to use by or on the order 
of a licensed veterinarian.
    (b) [Reserved]

[42 FR 58167, Nov. 8, 1977, as amended at 45 FR 81038, Dec. 9, 1980; 50 
FR 41489, Oct. 11, 1985; 50 FR 45603, Nov. 1, 1985; 52 FR 25212, July 6, 
1987; 56 FR 67175, Dec. 30, 1991; 56 FR 14642, Apr. 11, 1991; 63 FR 
51822, Sept. 29, 1998; 64 FR 48544, Sept. 7, 1999; 66 FR 22117, May 3, 
2001]



Sec.  522.1085  Guaifenesin sterile powder.

    (a) Specifications. It is a sterile powder containing guaifenesin.
    (b) Sponsor. See Nos. 000856 and 037990 in Sec.  510.600(c) of this 
chapter.
    (c) Conditions of use. (1) It is indicated for intravenous use as a 
muscle relaxant in horses.
    (2) 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. It is administered by rapid intravenous 
infusion at a fixed dosage of 1 milliliter of prepared solution per 
pound of body weight.
    (3) Not to be used in horses intended for food.
    (4) Federal law restricts this drug to use by or on the order of a 
licensed veterinarian.

[49 FR 48039, Dec. 10, 1984, as amended at 60 FR 27223, May 23, 1995; 67 
FR 67521, Nov. 6, 2002]



Sec.  522.1086  Guaifenesin injection.

    (a) Specifications. Each milliliter of sterile aqueous solution 
contains 50 milligrams of guaifenesin and 50 milligrams of dextrose.
    (b) Sponsor. See Nos. 037990 and 059130 in Sec.  510.600(c) of this 
chapter.
    (c) [Reserved]
    (d) Conditions of use. (1) The drug is used intravenously in horses 
as a skeletal muscle relaxant.
    (2) Administer rapidly at a dosage of 1 milliliter per pound of body 
weight.
    (3) No to be used in horses intended for food.
    (4) Federal law restricts this drug to use by or on the order of a 
licensed veterinarian.

[60 FR 27223, May 23, 1995, as amended at 63 FR 29352, May 29, 1998]



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. For intravenous use only. Overdosage or an 
excessive rate

[[Page 248]]

of administration (greater than 10 milliliters per kilogram per hour) 
may result in circulatory overload. 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]



Sec.  522.1145  Hyaluronate sodium injection.

    (a)(1) Specifications. Each milliliter of sterile aqueous solution 
contains 10 milligrams of hyaluronate sodium.
    (2) Sponsor. See 000009 in Sec.  510.600(c).
    (3) Conditions of use--(i) Amount. Small and medium-size joints 
(carpal, fetlock)--20 milligrams; larger joint (hock)--40 milligrams.
    (ii) Indications for use. Treatment of joint dysfunction in horses 
due to noninfectious synovitis associated with equine osteoarthritis.
    (iii) Limitations. For intra-articular injection in horses only. 
Treatment may be repeated at weekly intervals for a total of three 
treatments. Not for use in horses intended for food. 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.
    (2) Sponsor. See 053501 in Sec.  510.600(c) of this chapter.
    (3) Conditions of use--(i) Amount. Small and medium-size joints 
(carpal, fetlock)--10 milligrams; larger joint (hock)--20 milligrams.
    (ii) Indications for use. Treatment of joint dysfunction in horses 
due to noninfectious synovitis associated with equine osteoarthritis.
    (iii) Limitations. For intraarticular injection in horses only. 
Treatment may be repeated at weekly intervals for a total of four 
treatments. Not for use in horses intended for food. 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 000856 in Sec.  510.600(c) of this chapter.
    (3) Conditions of use--(i) Amount. Small and medium-size joints 
(carpal, fetlock)--20 milligrams.
    (ii) Indications for use. Treatment of carpal or fetlock joint 
dysfunction in horses due to acute or chronic noninfectious synovitis 
associated with equine osteoarthritis.
    (iii) Limitations. For intraarticular injection in horses only. 
Treatment may be repeated after 1 or more weeks but not to exceed 2 
injections per week for a total of 4 weeks. Not for use in horses 
intended for food. 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. For intraarticular injection in horses only. Not 
for use in horses intended for food. Not intended for use in breeding 
animals. Federal law restricts this drug to use by or on the order of a 
licensed veterinarian.
    (e)(1) Specifications. Each milliliter of sterile aqueous solution 
contains 10 milligrams of hyaluronate sodium.
    (2) Sponsor. See 000859 in Sec.  510.600(c)(2) of this chapter.
    (3) Conditions of use--(i) Amount. Intraarticular: 20 milligrams in 
the carpus or fetlock. Intravenous: 40 milligrams slowly into the 
jugular vein.
    (ii) Indications for use. Treatment of carpal or fetlock joint 
dysfunction in horses due to noninfectious synovitis associated with 
equine osteoarthritis.
    (iii) Limitations. For intraarticular or intravenous use in horses 
only. Treatment may be repeated at weekly intervals for a total of three 
treatments. Not for use in horses intended for food. The safety of use 
of this drug in breeding animals has not been determined. 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,

[[Page 249]]

fetlock)--22 milligrams; larger joint (hock)--44 milligrams.
    (ii) Indications for use. Treatment of joint dysfunction in horses 
due to noninfectious synovitis associated with equine osteoarthritis.
    (iii) Limitations. For intra-articular injection in horses only. 
Treatment may be repeated at weekly intervals for a total of three 
treatments. Not for use in horses intended for food. 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]



Sec.  522.1150  Hydrochlorothiazide injection.

    (a) Specifications. Each milliliter contains 25 milligrams of 
hydrochlorothiazide.
    (b) Sponsor. See No. 050604 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.\1\
---------------------------------------------------------------------------

    \1\ These conditions are NAS/NRC reviewed and deemed effective. 
Applications for these uses need not include effectiveness data as 
specified by Sec.  514.111 of this chapter, but may require 
bioequivalency and safety information.
---------------------------------------------------------------------------

    (3) Limitations. Animals should be regularly and carefully observed 
for early signs of fluid and electrolyte imbalance. Take appropriate 
countermeasures if this should occur. 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.\1\

[43 FR 59058, Dec. 19, 1978, as amended at 62 FR 63271, Nov. 28, 1997]



Sec.  522.1155  Imidocarb dipropionate sterile powder.

    (a) Specifications. Imidocarb dipropionate powder is reconstituted 
with sterile water. Each milliliter of solution contains 100 milligrams 
of imidocarb base.
    (b) Sponsor. No. 000061 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use. The drug is used in horses and zebras as 
follows:
    (1) Amount. For Babesia caballi infections, use intramuscularly 2 
milligrams of imidocarb base per kilogram of body weight, repeating 
dosage once after 24 hours. For Babesia equi infections, use 4 
milligrams of imidocarb base per kilogram of body weight, 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. Administer intramuscularly in the neck region. Do 
not inject intravenously. Do not use for other equidae or for animals of 
other species. Do not use in horses less than 1 year old. Do not use for 
animals in near-term pregnancies. Imidocarb dipropionate is a 
cholinesterase inhibitor. Do not use this product simultaneously with or 
a few days before or after treatment with or exposure to cholinesterase-
inhibiting drugs, pesticides, or chemicals. Do not use in horses 
intended for food. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian. Imidocarb dipropionate is sold only 
under permit issued by the Director of the National Program Planning 
Staff, Veterinary Services, APHIS, USDA, to licensed or full-time State, 
Federal, or military veterinarians.

[43 FR 40455, Sept. 12, 1978, as amended at 46 FR 48642, Oct. 2, 1981; 
61 FR 8873, Mar. 6, 1996; 62 FR 61625, Nov. 19, 1997]



Sec.  522.1156  Imidocarb dipropionate solution.

    (a) Specifications. Each milliliter of injectable solution contains 
120 milligrams of imidocarb.
    (b) Sponsor. See No. 000061 in Sec.  510.600(c) of this chapter.
    (c) [Reserved]

[[Page 250]]

    (d) Conditions of use--(1) Dogs--(i) Amount. 6.6 milligrams 
imidocarb per kilogram (3 milligrams per pound) of body weight.
    (ii) Indications for use. Treatment of clinical signs of babesiosis 
and/or demonstrated Babesia organisms in the blood.
    (iii) Limitations. Use subcutaneously or intramuscularly. Not for 
intravenous use. Repeat the dose after 2 weeks for a total of two 
treatments. Imidocarb is a cholinesterase inhibitor. Do not use 
simultaneously with or a few days before or after treatment with or 
exposure to cholinesterase-inhibiting drugs, pesticides, or chemicals. 
Federal law restricts this drug to use by or on the order of a licensed 
veterinarian.
    (2) [Reserved]

[62 FR 66984, Dec. 23, 1997]



Sec.  522.1182  Iron dextran complex injection.

    (a)(1) Specifications. Each milliliter of sterile solution contains 
ferric hydroxide dextran complex equivalent to 100 milligrams of 
elemental iron. It contains 0.5 percent phenol as a preservative.
    (2) [Reserved]
    (3)(i) Sponsor. See No. 000856 in Sec.  510.600(c) of this chapter.
    (ii) Conditions of use. It is used in baby pigs as follows:
    (a) For the prevention of anemia due to iron deficiency, administer 
an initial intramuscular injection of 100 milligrams of elemental iron 
to each animal at 2 to 4 days of age. Dosage may be repeated in 14 to 21 
days.
    (b) For the treatment of anemia due to iron deficiency, administer 
and intramuscular injection of 200 milligrams of elemental iron.
    (4)(i) Sponsor. See Nos. 000061 and 062408 in Sec.  510.600(c) of 
this chapter.
    (ii) Conditions of use. It is used in baby pigs as follows:
    (a) For the prevention of iron deficiency anemia, administer 
intramuscularly an amount of drug containing 100 to 150 milligrams of 
elemental iron to animals from 1 to 3 days of age.
    (b) For the treatment of iron deficiency anemia, administer 
intramuscularly an amount of drug containing 100 to 200 milligrams of 
elemental iron per animal. Dosage may be repeated in 10 days to 2 weeks.
    (b)(1) Specifications. Each milliliter of sterile solution contains 
ferric hydroxide in complex with dextran equivalent to 200 milligrams of 
elemental iron. It contains 0.5 percent phenol as a preservative.
    (2)(i) Sponsor. See Nos. 000010 and 059130 in Sec.  510.600(c) of 
this chapter.
    (ii) Conditions of use. It is used in baby pigs as follows:
    (a) For prevention of baby pig anemia due to iron deficiency, 
intramuscularly inject 200 milligrams of elemental iron (1 milliliter) 
at 1 to 3 days of age.
    (b) For treatment of baby pig anemia due to iron deficiency, 
intramuscularly inject 200 milligrams of elemental iron at the first 
sign of anemia.

[49 FR 38938, Oct. 2, 1984, as amended 52 FR 7832, Mar. 13, 1987; 53 FR 
40727, Oct. 18, 1988; 54 FR 41442, Oct. 10, 1989; 61 FR 18672, Apr. 29, 
1996; 62 FR 35076, June 30, 1997; 63 FR 53578, Oct. 6, 1998]



Sec.  522.1183  Iron hydrogenated dextran injection.

    (a) Specifications. Each milliliter contains 100 milligrams of 
elemental iron stabilized with a low molecular weight hydrogenated 
dextran and 0.5 percent phenol as a preservative.
    (b)-(c) [Reserved]
    (d)(1) Sponsor. See No. 000003 in Sec.  510.600(c) of this chapter.
    (2) Conditions of use. It is used in baby pigs as follows:
    (i) For the prevention of anemia due to iron deficiency, administer 
by intramuscular or subcutaneous injection of 100 milligrams of 
elemental iron to each animal at 2 to 4 days of age.
    (ii) For the treatment of anemia due to iron deficiency, administer 
by intramuscular or subcutaneous injection of 100 milligrams of 
elemental iron in baby pigs up to 4 weeks of age.
    (e)(1) Sponsors. See Nos. 000010, 017287, and 059130 in Sec.  
510.600(c) of this chapter.
    (2) Conditions of use. It is used in baby pigs as follows:
    (i) For the prevention of iron deficiency anemia, administer 
intramuscularly 100 milligrams at 2 to 4 days of age.
    (ii) For the treatment of iron deficiency anemia, administer

[[Page 251]]

intramuscularly 100 milligrams. Treatment may be repeated in 10 days.

[42 FR 53955, Oct. 4, 1977, as amended at 46 FR 39128, July 31, 1981; 50 
FR 23298, June 3, 1985; 52 FR 18691, May 19, 1987; 52 FR 36023, Sept. 
25, 1987; 53 FR 40728 and 40729, Oct. 18, 1988; 55 FR 8462, Mar. 8, 
1990; 55 FR 33670, Aug. 17, 1990; 62 FR 35076, June 30, 1997; 63 FR 
44384, Aug. 19, 1998; 65 FR 45877, July 26, 2000; 66 FR 22117, May 3, 
2001]



Sec.  522.1192  Ivermectin injection.

    (a) Specifications--(1) Horses. Each milliliter of sterile aqueous 
solution contains 20 milligrams of ivermectin (2 percent).
    (2) Cattle, reindeer, swine, and American bison. Each milliliter of 
sterile aqueous solution contains 10 milligrams of ivermectin (1 
percent).
    (3) Piglets 70 pounds or less and ranch-raised foxes. Each 
milliliter of sterile aqueous solution contains 2.7 milligrams of 
ivermectin (0.27 percent).
    (b) Sponsors. See No. 050604 in Sec.  510.600(c) of this chapter for 
use as in paragraph (d) of this section. See No. 059130 in Sec.  
510.600(c) of this chapter for use as in paragraphs (d)(2), (d)(3), 
(d)(4), and (d)(6) of this section.
    (c) Related tolerances. See Sec.  556.344 of this chapter.
    (d) Conditions of use--(1) Horses--(i) Amount. 20 milligrams per 100 
kilograms (220 pounds) of body weight.
    (ii) Indications for use. It is used in horses for the treatment and 
control of large strongyles (adult) (Strongylus vulgaris, Strongylus 
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. For intramuscular use only. Do not use 
intravenously. Not for use in horses intended for food. Effects of this 
drug on pregnant mares have not been determined. Federal law restricts 
this drug to use by or on the order of a licensed veterinarian.
    (2) Cattle--(i) Amount. 10 milligrams per 50 kilograms (110 pounds) 
body weight (200 micrograms per kilogram).
    (ii) Indications for use. It is used in cattle 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 (first, second, and third instars) (Hypoderma bovis, 
H. lineatum); lice (Linognathus vituli, Haematopinus eurysternus, 
Solenopotes capillatus); mites (Psoroptes ovis (syn. P. communis var. 
bovis), Sarcoptes scabiei var. bovis). It is also used to control 
infections of D. viviparus for 28 days after treatment, and O. ostertagi 
for 21 days after treatment, and H. placei, T. axei, C. punctata, C. 
oncophora, and Oesophagostomum radiatum for 14 days after treatment.
    (iii) Limitations. For subcutaneous use only. Not for intramuscular 
use. 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. Do not use in other animal species because 
severe adverse reactions, including fatalities in dogs, may result. 
Consult your veterinarian for assistance in the diagnosis, treatment, 
and control of parasitism.
    (3) Reindeer--(i) Amount. 10 milligrams per 50 kilograms (110 
pounds) body weight.
    (ii) Indications for use. It is used in reindeer for treatment and 
control of warbles (Oedemagena tarandi).
    (iii) Limitations. For subcutaneous use only. Not for intramuscular 
use. Do not treat reindeer within 56 days of slaughter. Federal law 
restricts this drug to use by or on the order of a licensed 
veterinarian.
    (4) Swine--(i) Amount. 300 micrograms per kilogram (2.2 pounds).
    (ii) Indications for use. It is used in swine for treatment and 
control of gastrointestinal roundworms (adults and fourth-stage larvae) 
(large roundworm,

[[Page 252]]

Ascaris suum; red stomach worm, Hyostrongylus rubidus; nodular worm, 
Oesophagostomum spp.; threadworm, Strongyloides ransomi (adults only)); 
somatic roundworm larvae (threadworm, Strongyloides ransomi (somatic 
larvae)); lungworms (Metastrongylus spp. (adults only)); lice 
(Haematopinus suis); and mites (Sarcoptes scabiei var. suis).
    (iii) Limitations. For subcutaneous injection in the neck of swine 
only. Do not treat swine within 18 days of slaughter. Do not use in 
other animal species as severe adverse reactions, including fatalities 
in dogs, may result. Consult your veterinarian for assistance in the 
diagnosis, treatment, and control of parasitism.
    (5) Ranch-raised foxes--(i) Amount. 200 micrograms per kilogram body 
weight. Repeat in 3 weeks.
    (ii) Indications for use. For treatment and control of ear mites 
(Otodectes cynotis).
    (iii) Limitations. For subcutaneous use only. Consult your 
veterinarian for assistance in the diagnosis, treatment, and control of 
parasitism.
    (6) American bison--(i) Amount. 200 micrograms per kilogram (10 
milligrams per 110 pounds) of body weight.
    (ii) Indications for use. It is used in American bison for the 
treatment and control of grubs (Hypoderma bovis).
    (iii) Limitations. For subcutaneous use. Do not slaughter within 56 
days of last treatment. Consult your veterinarian for assistance in the 
diagnosis, treatment, and control of parasitism.

[49 FR 5344, Feb. 13, 1984, as amended at 50 FR 30268, July 25, 1985; 51 
FR 25686, July 16, 1986; 51 FR 27021, July 29, 1986; 51 FR 29463, Aug. 
18, 1986; 53 FR 11064, Apr. 5, 1988; 56 FR 14020, Apr. 5, 1991; 60 FR 
45041, Aug. 30, 1995; 62 FR 14634, Mar. 27, 1997; 62 FR 63271, Nov. 28, 
1997; 63 FR 7702, Feb. 17, 1998; 64 FR 26671, May 17, 1999; 66 FR 13236, 
Mar. 5, 2001]



Sec.  522.1193  Ivermectin and clorsulon injection.

    (a) Specifications. Each milliliter of sterile aqueous solution 
contains 10 milligrams (1 percent) of ivermectin and 100 milligrams (10 
percent) of clorsulon.
    (b) Sponsor. See 050604 in Sec.  510.600(c) of this chapter.
    (c) Related tolerances. See Sec. Sec.  556.163 and 556.344 of this 
chapter.
    (d) Conditions of use--(1) Amount. 1 milliliter (10 milligrams of 
ivermectin and 100 milligrams of clorsulon) per 50 kilograms (110 
pounds).
    (2) Indications for use. It is used in cattle 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). It is also used to control infections of D. viviparus for 28 
days afer treatment, O. ostertagi for 21 days after treatment, and H. 
placei, T. axei, C. punctata, C. oncophora, and O. radiatum for 14 days 
after treatment.
    (3) Limitations. For subcutaneous use only. Not for intravenous or 
intramuscular use. Do not treat cattle within 49 days of slaughter. 
Because a withdrawal time in milk has not been established, do not use 
in female dairy cattle of breeding age. Do not use in other animal 
species because severe adverse reactions, including fatalities in dogs, 
may result. Consult your veterinarian for assistance in the diagnosis, 
treatment, and control of parasitism.

[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]



Sec.  522.1204  Kanamycin sulfate injection.

    (a) Specifications. Each milliliter of kanamycin sulfate injection 
veterinary contains either 50 or 200 milligrams of kanamycin.
    (b) Sponsor. See No. 000856 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use. (1) It is used in the treatment of bacterial 
infections due to kanamycin sensitive organisms in dogs and cats.
    (2) It is administered subcutaneously or intramuscularly at 5 
milligrams per

[[Page 253]]

pound of body weight per day in equally divided doses at 12-hour 
intervals.
    (3) Its label shall bear an appropriate expiration date.
    (4) Restricted to use by or on the order of a licensed veterinarian.

[40 FR 13858, Mar. 27, 1975, as amended at 53 FR 27851, July 25, 1988; 
64 FR 403, Jan. 5, 1999]



Sec.  522.1222  Ketamine hydrochloride injectable dosage forms.



Sec.  522.1222a  Ketamine.

    (a) Specifications. Each milliliter contains ketamine hydrochloride 
equivalent to 100 milligrams (mg) ketamine base activity.
    (b) Sponsors. See Nos. 000010, 000074, 000856, 059130, 061690, 
064408, and 064847 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.
    (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]



Sec.  522.1222b  Ketamine hydrochloride with promazine hydrochloride and aminopentamide hydrogen sulfate injection.

    (a) Chemical name. Ketamine hydrochloride, (+/-),-2-(o-
chlorophenyl)-2-(methylamino) cyclohexanone hydrochloride, with 
promazine hydrochloride, 10-[3-(dimethylamino) propyl] phenothiazine 
monohydrochloride, and aminopentamide hydrogen sulfate.
    (b) Specifications. The drug is a sterile aqueous solution and each 
milliliter contains: Ketamine hydrochloride equivalent to 100 milligrams 
ketamine base activity, 7.5 milligrams of promazine hydrochloride, and 
0.0625 milligram of aminopentamide hydrogen sulfate, with 1:10,000 
benzethonium chloride.
    (c) Sponsor. See Code No. 000856 in Sec.  510.600(c) of this 
chapter.
    (d) Special considerations. Store in a cool place. Protect from 
light. Do not use if precipitate appears.
    (e) Conditions of use. (1) It is used in cats as the sole anesthetic 
agent for ovariohysterectomy and general surgery.
    (2) It is administered intramuscularly at a recommended dose from 15 
to 20 milligrams ketamine base per pound of body weight, depending on 
the effect desired.
    (3) Federal law restricts this drug to use by or on the order of a 
licensed veterinarian.

[40 FR 59342, Dec. 23, 1975, as amended at 42 FR 3838, Jan. 21, 1977; 53 
FR 27851, July 25, 1988]



Sec.  522.1225  Ketoprofen solution.

    (a) Specifications. Each milliliter of sterile aqueous solution 
contains 100 milligrams of ketoprofen.
    (b) Sponsor. See 000856 in 21 CFR 510.600(c) of this chapter.
    (c) Conditions of use in horses--(1) Amount. 1.0 milligram 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. For intravenous use only. Do not use in breeding 
animals. Effects on fertility, pregnancy, or fetal health have not been 
determined. Not for use in horses intended for food. Federal law 
restricts this drug to use by or on the order of a licensed 
veterinarian.

[55 FR 40653, Oct. 4, 1990]



Sec.  522.1228  [Reserved]



Sec.  522.1244  Levamisole phosphate injection.

    (a) Specifications. Each milliliter of sterile aqueous 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 057561 in Sec.  510.600 of this 
chapter for use of 13.65 percent injection, and see No. 053501 for use 
of 13.65 and 18.2 percent injection.

[[Page 254]]

    (c) 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 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]



Sec.  522.1260  Lincomycin.

    (a) Specifications. Each milliliter of solution contains lincomycin 
hydrochloride monohydrate equivalent to 25, 50, 100, or 300 milligrams 
(mg) of lincomycin.
    (b) Sponsors. See sponsors in Sec.  510.600(c) of this chapter for 
uses as in paragraph (e) of this section.
    (1) No. 000009 for uses as in paragraph (e) of this section.
    (2) No. 046573 for use 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]



Sec.  522.1289  Lufenuron suspension.

    (a) Specifications. Each milliliter of sterile aqueous suspension 
contains 10 milligrams of lufenuron.
    (b) Sponsor. See No. 058198 in Sec.  510.600(c) of this chapter.
    (c) [Reserved]
    (d) Conditions of use--(1) Cats--(i) Amount. 10 milligrams per 
kilogram (4.5 milligrams per pound) of body weight every 6 months, 
subcutaneously.
    (ii) Indications for use. For use in cats 6 weeks of age and older, 
for control of flea populations. Lufenuron controls flea populations by 
preventing the development of flea eggs and does not kill adult fleas. 
Concurrent use of insecticides may be necessary for adequate control of 
adult fleas.
    (iii) Limitations. For subcutaneous use in cats only. The safety of 
this product in reproducing animals has not been established. Do not use 
in dogs. Federal law restricts this drug to use by or on the order of a 
licensed veterinarian.

[[Page 255]]

    (2) [Reserved]

[63 FR 29552, June 1, 1998]



Sec.  522.1290  Luprostiol sterile solution.

    (a) Specifications. Each milliliter of sterile solution contains 7.5 
milligrams of luprostiol.
    (b) Sponsor. See No. 057926 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--(1) Amount. 7.5 milligrams per mare.
    (2) Indications for use. The drug is used in mares for estrus 
control and termination of pregnancy.
    (3) Limitations. Administer by intramuscular injection only. Not for 
use in horses intended for food. Federal law restricts this drug to use 
by or on the order of a licensed veterinarian.

[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]



Sec.  522.1335  Medetomidine hydrochloride injection.

    (a) Specifications. Each milliliter of sterile aqueous solution 
contains 1.0 milligram of medetomidine hydrochloride.
    (b) Sponsor. See 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. Do not use in dogs with cardiac disease, 
respiratory disorders, liver or kidney diseases, dogs in shock, dogs 
which are severly debilitated, or dogs which are stressed due to extreme 
heat, cold, or fatigue. Allow agitated dogs to rest quietly before 
administration. Do not repeat dosing in dogs not responding 
satisfactorily to treatment. Do not use in breeding or pregnant animals. 
Federal law restricts this drug to use by or on the order of a licensed 
veterinarian.

[61 FR 21075, May 9, 1996]



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 dihydrochloride 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 No. 050604 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use--(1) Amount. For asymptomatic to moderate 
(class 1 to class 2) heartworm disease: 2.5 milligrams per kilogram of 
body weight (1.1 milligram per pound) twice, 24 hours apart. The series 
can be repeated in 4 months depending on the response to the first 
treatment and the condition, age, and use of the dog. For severe (class 
3) heartworm disease: Single injection of 2.5 milligrams per kilogram 
followed, approximately 1 month later,

[[Page 256]]

by 2.5 milligrams per kilogram administered twice, 24 hours apart.
    (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. Administer only by deep intramuscular injection in 
the lumbar muscles (L3-L5). Use a 23 gauge 1 inch 
needle for dogs less than or equal to 10 kilograms (22 pounds) and a 22 
gauge 1 1/2 inch needle for dogs greater than 10 kilograms (22 pounds). 
Use alternate sides with each administration. The drug is 
contraindicated in dogs with class 4 (very severe) heartworm disease 
(Caval Sydrome). Not for use in breeding animals and lactating or 
pregnant bitches. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[60 FR 49340, Sept. 25, 1995]



Sec.  522.1372  Mepivacaine hydrochloride injection.

    (a) Specifications. Each milliliter of sterile aqueous solution 
contains 20 milligrams of mepivacaine hydrochloride.
    (b) Sponsor. See No. 000009 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use. (1) It is intended for use in horses 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.
    (2) It is administered as follows: for nerve block, 3 to 15 
milliliters; for epidural anesthesia, 5 to 20 milliliters; for intra-
articular anesthesia, 10 to 15 milliliters; for infiltration, as 
required; for anesthesia of the laryngeal mucosa prior to 
ventriculectomy, by topical spray, 25 to 40 milliliters, by 
infiltration, 20 to 50 milliliters.
    (3) Not for use in horses intended for food.
    (4) Federal law restricts this drug to use by or on the order of a 
licensed veterinarian.

[42 FR 5349, Jan. 28, 1977, as amended at 42 FR 36995, July 19, 1977; 55 
FR 23076, June 6, 1990]



Sec.  522.1380  Methocarbamol injection.

    (a) Specifications. The product is a sterile, pyrogen-free solution, 
each milliliter containing 100 milligrams of methocarbamol, 0.5 
milliliter of polyethylene glycol 300, and water for injection q.s. Its 
pH is 3.5 to 6.0.
    (b) Sponsor. See No. 000856 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use--(1) Amount--(i) Dogs and cats. 20 milligrams 
per pound of body weight for moderate conditions, 25 to 100 milligrams 
per pound of body weight for severe conditions (tetanus and strychnine 
poisoning), total cumulative dose not to exceed 150 milligrams per pound 
of body weight.
    (ii) Horses. 2 to 10 milligrams per pound of body weight for 
moderate conditions, 10 to 25 milligrams 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. For intravenous use only. For dogs, administer 
rapidly half the estimated dose, pause until the animal starts to relax, 
then continue administration to effect. For horses, administer rapidly 
to effect. Not for horses intended for food use. Federal law restricts 
this drug to use by or on the order of a licensed veterinarian.

[45 FR 79758, Dec. 2, 1980, as amended at 46 FR 18964, Mar. 27, 1981; 67 
FR 67521, Nov. 6, 2002]



Sec.  522.1410  Sterile methylprednisolone acetate suspension.

    (a) Specifications. Each milliliter of aqueous suspension contains 
20 or 40 milligrams of methylprednisolone acetate.\1\
---------------------------------------------------------------------------

    \1\ These conditions are NAS/NRC reviewed and deemed effective. 
Applications for these uses need not include effectiveness data as 
specified by Sec.  514.111 of this chapter, but may require 
bioequivalency and safety information.
---------------------------------------------------------------------------

    (b) Sponsors. See Nos. 000009 and 000010 in Sec.  510.600(c) of this 
chapter.

[[Page 257]]

    (c) Special considerations. (1) Clinical and experimental data have 
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.
    (2) Systemic therapy with methylprednisolone acetate, as with other 
corticoids, is contraindicated in animals with arrested tuberculosis, 
peptic ulcer, and Cushing's syndrome. The presence of active 
tuberculosis, diabetes mellitus, osteoporosis, renal insufficiency, 
predisposition to thrombophlebitis, hypertension, or congestive heart 
failure necessitates carefully controlled use of corticosteroids. 
Intrasynovial, intratendinous, or other injections of corticosteroids 
for local effect are contraindicated in the presence of acute infectious 
conditions. Exacerbation of pain, further loss of joint motion, with 
fever and malaise following injection may indicate that the condition 
has become septic. Appropriate antibacterial therapy should be 
instituted immediately.
    (d) Conditions of use--(1) Amount--(i) Intramuscular. Dosage may be 
repeated when necessary, as follows: dogs--2 to 40 milligrams (up to 120 
milligrams in extremely large breeds or dogs with severe involvement); 
cats--10 to 20 milligrams; horses--200 milligrams. \1\
    (ii) Intrasynovial. Dosage may be repeated when necessary, as 
follows: horses--40 to 240 milligrams; dogs--up to 20 milligrams.\1\
    (2) Indications for use. Treatment of inflammation and related 
disorders in dogs, cats, and horses; \1\ treatment of allergic and 
dermatologic disorders in dogs and cats; and as supportive therapy to 
antibacterial treatment of severe infections in dogs and cats.
    (3) Limitations. Not for use in horses intended for food. Not for 
human use. 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]



Sec.  522.1451  Moxidectin.

    (a) Specifications. The drug product consists of two separate vials. 
One contains 10 percent moxidectin microspheres, and the other contains 
a vehicle for constitution of the moxidectin microspheres. Each 
milliliter of constituted, sustained-release suspension contains 3.4 
milligrams (mg) of moxidectin.
    (b) Sponsor. See No. 000856 in Sec.  510.600(c) of this chapter.
    (c) [Reserved]
    (d) Conditions of use; dogs--(1) Amount. 0.17 mg per kilogram body 
weight (0.0773 mg per pound) as a single subcutaneous injection.
    (2) Indications for use. For prevention of heartworm disease caused 
by Dirofilaria immitis; 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.

[66 FR 35756, July 9, 2001, as amended at 67 FR 57944, Sept. 13, 2002]



Sec.  522.1452  Nalorphine hydrochloride injection.

    (a) Specifications. Each milliliter of aqueous solution contains 5 
milligrams of nalorphine hydrochloride.
    (b) Sponsor. See No. 050604 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use--(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. Successive doses of the drug gradually lose their 
analeptic effect and eventually induce respiratory depression equal to 
that of opiates. Therefore, do not exceed therapeutic dosage. Do not mix 
drug with meperidine solutions because the buffer will cause 
precipitation. 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]

[[Page 258]]



Sec.  522.1462  Naloxone hydrochloride injection.

    (a) Specifications. Naloxone hydrochloride injection is an aqueous 
sterile solution containing 0.4 milligram of naloxone hydrochloride per 
milliliter.
    (b) Sponsor. See No. 060951 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use. (1) It is used as a narcotic antagonist in 
dogs.
    (2) It is administered by intravenous, intramuscular, or 
subcutaneous injection at an initial dose of 0.04 milligram per kilogram 
of body weight. When given intravenously, the dosage may be repeated at 
2- to 3-minute intervals as necessary. Onset of action by intramuscular 
or subcutaneous injection is slightly longer than it is by intravenous 
injection, and repeated dosages must be administered accordingly.
    (3) For use only by or on the order of a licensed veterinarian.

[40 FR 13858, Mar. 27, 1975, as amended at 47 FR 20757, May 14, 1982; 54 
FR 32632, Aug. 9, 1989; 63 FR 7701, Feb. 17, 1998]



Sec.  522.1465  Naltrexone hydrochloride injection.

    (a) Specifications. Each milliliter of sterile aqueous 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. Available data are inadequate to recommend use in 
pregnant animals. Avoid using during breeding season. 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]



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 000856 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]



Sec.  522.1484  Neomycin sulfate sterile solution.

    (a) Specifications. Each milliliter of sterile aqueous solution 
contains 50 milligrams of neomycin sulfate (equivalent to 35 milligrams 
of neomycin base).\1\
---------------------------------------------------------------------------

    \1\ These claims are NAS/NRC reviewed and deemed effective. 
Applications for these uses need not include effectiveness data as 
specified by Sec.  514.111 of this chapter.
---------------------------------------------------------------------------

    (b) Sponsor. See No. 000009 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use--(1) Amount. 5 milligrams per pound of body 
weight daily divided into portions administered every 6 to 8 hours for 3 
to 5 days.\1\
    (2) Indications for use. Administer to dogs and cats for the 
treatment of acute and chronic bacterial infections due to organisms 
susceptible to neomycin.\1\
    (3) Limitations. For intramuscular or intravenous use only. Neomycin 
is not for use parenterally in food-producing animals because of 
prolonged residues in edible tissues. Labeling shall bear an appropriate 
expiration date. For use by

[[Page 259]]

or on the order of a licensed veterinarian.\1\

[43 FR 48996, Oct. 20, 1978, as amended at 64 FR 403, Jan. 5, 1999]



Sec.  522.1503  Neostigmine methylsulfate injection.

    (a) Specifications. Neostigmine methylsulfate injection contains two 
milligrams of neostigmine methylsulfate in each milliliter of sterile 
aqueous solution.
    (b) Sponsor. See No. 000061 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use. (1) The drug is intended for use for treating 
rumen atony; initiating peristalsis which causes evacuation of the 
bowel; emptying the urinary bladder; and stimulating skeletal muscle 
contractions. It is a curare antagonist.
    (2) It is administered to cattle and horses at a dosage level of 1 
milligram per 100 pounds of body weight subcutaneously. It is 
administered to sheep at a dosage level of 1 to 1\1/2\ milligrams per 
100 pounds body weight subcutaneously. It is administered to swine at a 
dosage level of 2 to 3 milligrams per 100 pounds body weight 
intramuscularly. These doses may be repeated as indicated.
    (3) The drug is contraindicated in mechanical, intestinal or urinary 
obstruction, late pregnancy, and in animals treated with other 
cholinesterase inhibitors.
    (4) Not for use in animals producing milk, since this use will 
result in contamination of the milk.
    (5) 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]



Sec.  522.1610  Oleate sodium solution.

    (a) Specifications. Each milliliter of sterile aqueous solution 
contains 50 milligrams of sodium oleate.
    (b) Sponsor. See No. 037990 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use--(1) It is used in horses to stimulate 
infiltration of cellular blood components that subsequently 
differentiate into fibrous and/or fibrocartilagenous tissue.
    (2) The drug is administered by parenteral injection dependent upon 
the area of response desired. An injection of 1 milliliter will produce 
a response of approximately 15 square centimeters. Do not inject more 
than 2 milliliters per injection site. Regardless of the number of 
injection sites, the total volume used should not exceed 10 milliliters.
    (3) Not for use in horses intended for food.
    (4) 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]



Sec.  522.1620  Orgotein for injection.

    (a) Specifications. Orgotein for injection is packaged in a vial 
containing 5 milligrams of orgotein and 10 milligrams of sucrose as 
lyophilized sterile nonpyrogenic powder with directions for dissolving 
the contents of the vial in 2 milliliters of diluent which is sodium 
chloride injection, U.S.P.
    (b) Sponsor. See No. 024991 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use--(1) Horses. (i) It is used in the treatment 
of soft tissue inflammation associated with the musculoskeletal system.
    (ii) It is administered by deep intramuscular injection at a dosage 
level of 5 milligrams every other day for 2 weeks and twice weekly for 2 
to 3 more weeks. Severe cases, both acute and chronic, may benefit more 
from daily therapy initially. Dosage may be continued beyond 5 weeks if 
satisfactory improvement has not been achieved.
    (iii) Not for use in horses intended for food.
    (2) Dogs. (i) It is used for the relief of inflammation associated 
with ankylosing spondylitis, spondylosis, and disc disease. When severe 
nerve damage is present, response will occur much more slowly, if at 
all.
    (ii) It is administered by subcutaneous injection at a dosage level 
of 5 milligrams every day for 6 days, and thereafter, every other day 
for 8 days. In less severe conditions, shorter courses of therapy may be 
indicated.

[[Page 260]]

    (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 41 FR 32583, Aug. 4, 1976]



Sec.  522.1642  Oxymorphone hydrochloride injection.

    (a) Specifications. The drug contains 1 or 1.5 milligrams of 
oxymorphone hydrochloride per milliliter of aqueous solution containing 
0.8 percent sodium chloride.
    (b) Sponsor. See No. 060951 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use. (1) The drug is a narcotic analgesic, 
preanesthetic, anesthetic, and substitute anesthetic adjuvant for 
intramuscular, subcutaneous or intravenous administration to cats and 
dogs as follows:

------------------------------------------------------------------------
                                                                Dosage
           Animal                  Body weight (pounds)      (milligram)
------------------------------------------------------------------------
Dogs........................  2 to 5.......................         0.75
                              5 to 15......................     0.75-1.5
                              15 to 30.....................      1.5-2.5
                              30 to 60.....................      2.5-4.0
                              Over 60......................          4.0
Cats........................  Small........................     0.4-0.75
                              Large........................     0.75-1.5
------------------------------------------------------------------------

    (2) Do not mix with a barbiturate in the same syringe to preclude 
precipitation.
    (3) It tends to depress respiration. Naloxone hydrochloride and 
other narcotic antagonists are used to counter over-dosing.
    (4) 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 63 FR 7701, Feb. 17, 1998]



Sec.  522.1660  Oxytetracycline injection.

    (a) Specifications. Each milliliter of sterile solution contains 200 
milligrams of oxytetracycline base.
    (b) Sponsors. See 000010, 000069, 011722, 053389, 059130, and 061623 
in Sec.  510.600(c) of this chapter.
    (c) Related tolerances. See Sec.  556.500 of this chapter.
    (d) Conditions of use--(1) Beef cattle, dairy cattle, and calves 
including preruminating (veal) calves.--(i) 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 advanced cases of other indicated diseases; 9 milligrams per pound 
of body weight as a single dosage where retreatment for anaplasmosis is 
impractical; 9 milligrams per pound of body weight as single dosage 
where retreatment of calves and yearlings for bacterial pneumonia is 
impractical; 9 milligrams per pound of body weight as a single dosage 
for treatment of infectious bovine keratoconjunctivitis.
    (ii) Indications for use. Treatment of diseases due to 
oxytetracycline-susceptible organisms as follows: Pneumonia and shipping 
fever complex associated with Pasteurella spp. and Haemophilis 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 infectious bovine keratoconjunctivitis (pinkeye) 
caused by Moraxella bovis. If labeled for use by or on the order of a 
licensed veterinarian, it may also be used for treatment of anaplasmosis 
caused by Anaplasma marginale and anthrax caused by Bacillus anthracis.
    (iii) Limitations. Administer intramuscularly or intravenously at 
the 3 to 5 milligrams level, intramuscularly at the 9 milligrams level. 
Sponsors 000010, 011722, 053389, 055529, and 059130 may also administer 
subcutaneously at the 3 to 5 milligrams and 9 milligrams levels. 
Treatment of all diseases should be instituted early and continued 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, 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

[[Page 261]]

withdrawal time. Discontinue treatment at least 28 days prior to 
slaughter. For sponsor 061623: Not for use in lactating dairy cattle. 
For sponsors 000010, 000069, 011722, 053389, 055529, and 059130: Milk 
taken from animals during treatment and for 96 hours after the last 
treatment must not be used for food; use subcutaneously with a maximum 
of 10 milliliters per injection site in adult cattle as well as 
intramuscularly and intravenously.
    (2) Swine--(i) Amount. 3 to 5 milligrams of oxytetracycline per 
pound of body weight per day; 9 milligrams per pound of body weight as a 
single dosage where re-treatment for pneumonia is impractical. Sows: 
Administer once 3 milligrams of oxytetracycline per pound of body 
weight, approximately 8 hours before farrowing or immediately after 
completion of farrowing.
    (ii) Indications for use. 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.
    (iii) Limitations. Administer intramuscularly. Do not inject more 
than 5 milliliters per site in adult swine. Discontinue treatment at 
least 28 days prior to slaughter.

[45 FR 16479, Mar. 14, 1980, as amended at 46 FR 20160, Apr. 3, 1981; 46 
FR 27913, May 22, 1981; 52 FR 19502, May 26, 1987; 60 FR 14218, Mar. 16, 
1995; 60 FR 29755, June 6, 1995; 61 FR 31028, June 19, 1996; 61 FR 
36291, July 10, 1996; 62 FR 13825, Mar. 24, 1997; 62 FR 27692, May 21, 
1997; 63 FR 52158, Sept. 30, 1998; 64 FR 23187, Apr. 30, 1999; 64 FR 
26670, May 17, 1999; 64 FR 42831, Aug. 6, 1999; 66 FR 13235, Mar. 5, 
2001; 67 FR 12471, Mar. 19, 2002; 67 FR 47451, July 19, 2002; 67 FR 
72366, 72367, Dec. 5, 2002; 67 FR 78357, Dec. 24, 2002; 68 FR 8153, Feb. 
20, 2003]



Sec.  522.1662  Oxytetracycline hydrochloride implantation or injectable dosage forms.



Sec.  522.1662a  Oxytetracycline hydrochloride injection.

    (a)(1) Specifications. The drug contains 50 milligrams of 
oxytetracycline hydrochloride in each milliliter of sterile solution.
    (2) Sponsor. See No. 000010 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.
    (iv) For use only in beef cattle, beef calves, nonlactating dairy 
cattle, and dairy calves.
    (b)(1) Specifications. Each milliliter of sterile solution contains 
50 or 100 milligrams of oxytetracycline (as oxytetracycline 
hydrochloride).
    (2) Sponsor. See 000010 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

[[Page 262]]

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., Hemophilus 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.
    (c)(1) Specifications. The drug contains 50 or 100 milligrams of 
oxytetracycline hydrochloride in each milliliter of sterile solution.
    (2) Sponsor. See No. 000069 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., Hemophilus 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 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

[[Page 263]]

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.
    (d)(1) Specifications. The drug contains 50 milligrams of 
oxytetracycline hydrochloride in each milliliter of sterile solution.
    (2) Sponsor. See No. 000069 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 Hemophilus 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. 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

[[Page 264]]

to the dosage schedule given in paragraph (d)(3)(iii)(c) of this 
section. 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.
    (e)(1) Specifications. Each milliliter of sterile solution contains 
100 milligrams of oxytetracycline hydrochloride.
    (2) Sponsor. See No. 000069 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 Hemophilus 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, 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 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 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.
    (f) [Reserved]

[[Page 265]]

    (g)(1) Specifications. Each milliliter of sterile solution contains 
100 milligrams of oxytetracycline as oxytetracycline hydrochloride.
    (2) Sponsor. See No. 000010 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., Hemophilus 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 000010 in Sec.  510.600(c) of this chapter for use 
of 50 and 100 milligrams/milliliter solution, and see No. 059130 in 
Sec.  510.600(c) for use of 100 milligrams/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 Spherophorus 
necrophorus; 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 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

[[Page 266]]

before slaughter. Not for use in lactating dairy animals.
    (i)(1) Specifications. Each milliliter of sterile solution contains 
50 milligrams of oxytetracycline hydrochloride.
    (2) Sponsor. See No. 059130 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) [Reserved]
    (k)(1) Specifications. Each milliliter of sterile solution contains 
either 50 or 100 milligrams of oxytetracycline hydrochloride.
    (2) Sponsor. See No. 000864 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 Hemophilus 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 on GPO Access.



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. 000069 in Sec.  510.600(c) of this chapter.
    (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.

[[Page 267]]

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]



Sec.  522.1680  Oxytocin injection.

    (a) Specifications. Each milliliter of oxytocin injection contains 
20 U.S.P. units of oxytocin.
    (b) Sponsors. See Nos. 000010, 000856, 000864, 059130, 058639, and 
059130 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use\1\--(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:
---------------------------------------------------------------------------

    \1\ These conditions are NAS/NRC reviewed and deemed effective. 
Applications for these uses need not include effectiveness data as 
specified by Sec.  514.111 of this chapter, but may require bio-
equivalency and safety information.

------------------------------------------------------------------------
                                          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.
    (3) Limitations. Do not use in dystocia due to abnormal presentation 
of fetus until correction is accomplished. For prepartum usage, full 
relaxation of the cervix should be accomplished either naturally or by 
administration of estrogen prior to oxytocin therapy. 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, as amended at 52 
FR 18691, May 19, 1987; 52 FR 25212, July 6, 1987; 52 FR 36023, Sept. 
25, 1987; 53 FR 32610, Aug. 26, 1988; 53 FR 40728, Oct. 18, 1988; 54 FR 
41442, Oct. 10, 1989; 55 FR 8462, Mar. 8, 1990; 56 FR 14642, Apr. 11, 
1991, 56 FR 16002, Apr. 19, 1991; 59 FR 31139, June 17, 1994; 62 FR 
35076, June 30, 1997; 62 FR 38906, July 21, 1997; 65 FR 45877, July 26, 
2000; 66 FR 22117, May 3, 2001]



Sec.  522.1696  Penicillin G procaine implantation and injectable dosage forms.



Sec.  522.1696a  Penicillin G benzathine and penicillin G procaine sterile 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. 000008, 000856, 000864, 010515, and 049185 for use as in 
paragraph (d)(1) of this section.
    (2) Nos. 000856 and 049185 for use as in paragraphs (d)(2)(i), 
(d)(2)(ii)(A), and (d)(2)(iii) of this section.
    (3) Nos. 000864, 010515, and 059130 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.

[[Page 268]]

    (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) Conditions of use. Treatment of bacterial infections 
susceptible to penicillin G.
    (iii) Limitations. In beef cattle, treatment should be limited to 
two doses. Not for use in beef cattle within 30 days of slaughter. Do 
not use in horses intended for food purposes. 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) Conditions of use. (A) Treatment of bacterial pneumonia 
(Streptococcus spp., Corynebacterium pyogenes, Staphylococcus aureus); 
upper respiratory infections such as rhinitis or pharyngitis 
(Cpyogenes); 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. Limit treatment to two doses. Not for use within 
30 days of slaughter.

[66 FR 711, Jan. 4, 2001]



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. 010515, 053501, and 059130 for use as in paragraph (d) of 
this section.
    (2) Nos. 000864 and 055529 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.
    (A) For Nos. 000864, 010515, 053501, and 059130: Continue treatment 
at least 48 hours after symptoms disappear.
    (B) For No. 055529: Continue treatment at least 1 day after symptoms 
disappear (usually 2 or 3 days).
    (ii) Indications for use. Treatment of cattle and sheep for 
bacterial pneumonia (shipping fever) caused by Pasteurella multocida; 
swine for erysipelas caused by Erysipelothrix insidiosa; and horses for 
strangles caused by Streptococcus equi.
    (iii) Limitations. Not for use in horses intended for food.
    (A) For Nos. 000864, 010515, 053501, and 059130: Do not exceed 7 
days of treatment in nonlactating dairy and beef cattle, sheep, and 
swine, or 5 days in lactating cattle. Milk that has been taken during 
treatment and for 48 hours after the last treatment must not be used for 
food. 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. 055529: Treatment should not exceed 4 consecutive days. 
Milk that has been taken during treatment and for 72 hours after the 
last treatment must not be used for food. Discontinue treatment for the 
following number of days before slaughter: Cattle--10, sheep--9, and 
swine--7.

[66 FR 712, Jan. 4, 2001]



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. 053501 in Sec.  510.600(c) of this chapter.
    (c) National Academy of Sciences/National Research Council (NAS/NRC) 
status. The conditions of use were NAS/NRC reviewed and found effective. 
Applications for these uses need not include effectiveness data as 
specified by

[[Page 269]]

Sec.  514.111 of this chapter, but may require bioequivalency and safety 
information.
    (d) 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]



Sec.  522.1698  Pentazocine lactate injection.

    (a) Specifications. Each milliliter of sterile aqueous solution 
contains pentazocine lactate equivalent to 30 milligrams of pentazocine 
base.
    (b) Sponsor. See No. 000009 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use--(1) Horses--(i) Amount. 0.15 milligram of 
pentazocine base per pound of body weight per day.
    (ii) Indications for use. For symptomatic relief of pain due to 
colic.
    (iii) Limitations. Administer intravenously or intramuscularly. 
Intravenous injections are given slowly in the jugular vein. In cases of 
severe pain, a second dose is recommended intramuscularly 10 to 15 
minutes after the initial dose at the same level. Not for use in horses 
intended for food. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.
    (2) Dogs--(i) Amount. 0.75 to 1.50 milligrams of pentazocine base 
per pound of body weight.
    (ii) Indications for use. For amelioration of pain accompanying 
postoperative recovery, fracture, trauma, and spinal disorders.
    (iii) Limitations. Administer intramuscularly only. 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]



Sec.  522.1704  Sodium pentobarbital injection.

    (a)(1) Specifications. Sodium pentobarbital injection is sterile and 
contains in each milliliter 64.8 milligrams of sodium pentobarbital.
    (2) Sponsor. See No. 000061 in Sec.  510.600(c) of this chapter.
    (3) Conditions of use. (i) 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.
    (ii) The drug is administered intravenously ``to effect''. For 
general surgical anesthesia, the usual dose is 11 to 13 milligrams per 
pound of body weight. For sedation, the usual dose is approximately 2 
milligrams per pound of body weight. For relieving convulsive seizures 
in dogs, when caused by strychnine, the injection should be administered 
intravenously ``to effect''. The drug may be given intraperitoneally if 
desired. However, the results of such injections are less uniform. When 
given intraperitoneally, it is administered at the same dosage level as 
for intravenous administration. The dose must be reduced for animals 
showing under-nourishment, toxemia, shock and similar conditions.
    (iii) Federal law restricts this drug to use by or on the order of a 
licensed veterinarian.
    (b) [Reserved]

[40 FR 13858, Mar. 27, 1975, as amended at 45 FR 83483, Dec. 19, 1980; 
52 FR 25212, July 6, 1987; 62 FR 61625, Nov. 19, 1997; 66 FR 23588, May 
9, 2001]



Sec.  522.1720  Phenylbutazone injection.

    (a) Specifications. The drug contains 100 or 200 milligrams of 
phenylbutazone in each milliliter of sterile aqueous solution.
    (b) Sponsors. (1) Approval for use of the 200 milligrams per 
milliliter drug in dogs and horses: See sponsor Nos. 000061, 000856, 
058829, and 059130 in Sec.  510.600(c) of this chapter.
    (2) Approval for use of the 200 milligrams per milliliter drug for 
use in

[[Page 270]]

horses: See sponsor Nos. 000010 and 000864 in Sec.  510.600(c) of this 
chapter.
    (3) Approval for use of the 100 milligrams per milliliter drug in 
dogs and horses: See sponsor No. 000856 in Sec.  510.600(c) of this 
chapter.
    (4) Approval for use of the 200 milligrams per milliliter drug in 
dogs: See sponsor No. 000864 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use for dogs. (1) It is used for the relief of 
inflammatory conditions associated with the musculoskeletal system.
    (2) It is administered intravenously at a dosage level of 10 
milligrams per pound of body weight daily in 3 divided doses, not to 
exceed 800 milligrams daily regardless of weight. Limit intravenous 
administration to 2 successive days. Oral medication may follow.
    (3) Federal law restricts this drug to use by or on the order of a 
licensed veterinarian.
    (d) Conditions of use for horses. (1) It is used for the relief of 
inflammatory conditions associated with the musculoskeletal system.
    (2) It is administered intravenously at a dosage level of 1 to 2 
grams per 1,000 pounds of body weight daily in 3 divided doses, not to 
exceed 4 grams daily. Limit intravenous administration to not more than 
5 successive days.
    (3) Not for use in animals intended for food.
    (4) Federal law restricts this drug to use by or on the order of a 
licensed veterinarian.

[40 FR 13858, Mar. 27, 1975]

    Editorial Note: For Federal Register citations affecting Sec.  
522.1720, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and on GPO Access.



Sec.  522.1820  Pituitary luteinizing hormone 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) The drug is an aid in the treatment of 
breeding disorders related to pituitary hypofunction in cattle, horses, 
swine, sheep, and dogs.
    (2) Preferably given by intravenous injection, it may be 
administered subcutaneously; dosage is as follows: Cattle and horses, 25 
mg; swine, 5 mg; sheep, 2.5 mg, and dogs, 1.0 mg. Treatment may be 
repeated in 1 to 4 weeks, or as indicated.
    (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 52 FR 7832, Mar. 13, 1987]



Sec.  522.1850  Polysulfated glycosaminoglycan.

    (a) Specifications. Each 1-milliliter ampule of sterile aqueous 
solution contains 250 milligrams of polysulfated glycosaminoglycan; each 
5-milliliter ampule or vial contains 500 milligrams.
    (b) Sponsor. See No. 010797 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use--horses. (1) Indications for use. Polysulfated 
glycosaminoglycan is for the treatment of noninfectious degenerative 
and/or traumatic joint dysfunction and associated lameness of the carpal 
and hock joints in horses.-
    (2) Amount--(i) Intra-articular use (carpal): 250 milligrams once a 
week for 5 weeks. The joint area must be shaved, cleaned, and sterilized 
as in a surgical procedure prior to injection. If the joint reacts with 
excessive inflammation, after intra-articular treatment, cease therapy.
    (ii) Intramuscular use (carpal and hock): 500 milligrams every 4 
days for 28 days. Injection site must be thoroughly cleansed prior to 
injection.
    (3) Limitations. Not for use in horses intended for food. Safe use 
in breeding animals has not been established. Federal law restricts this 
drug to use by or on the order of a licensed veterinarian.
    (d) Conditions of use--dogs--(1) Indications for use. For control of 
signs associated with noninfectious degenerative and/or traumatic 
arthritis of canine synovial joints.
    (2) Dosage. 2 milligrams per pound of body weight by intramuscular 
injection.

[[Page 271]]

    (3) Limitations. Administer intramuscularly twice weekly for up to 4 
weeks (maximum of 8 injections). Do not exceed recommended dose or 
regimen. Do not mix with other drugs or solvents. Federal law restricts 
this drug to use by or on the order of a licensed veterinarian.

[54 FR 53053, Dec. 27, 1989, as amended at 61 FR 54333, Oct. 18, 1996; 
62 FR 45158, Aug. 26, 1997]



Sec.  522.1862  Sterile pralidoxime chloride.

    (a) Chemical name. 2-Formyl-1-methylpyridinium chloride oxime.
    (b) Specifications. Sterile pralidoxime chloride is packaged in 
vials. Each vial contains 1 gram of sterile pralidoxime chloride powder 
and includes directions for mixing this gram with 20 cubic centimeters 
of sterile water for injection prior to use.
    (c) Sponsor. See No. 000856 in Sec.  510.600(c) of this chapter.
    (d) Conditions of use. (1) 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.
    (2) It is administered 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 
milligram per pound of body weight, followed by administration of an 
additional 0.15 milligram 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 pralidoxime chloride when administered to horses is 2 
grams per horse. When administered to dogs and cats, it is 25 milligrams 
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.
    (3) For use only by or on the order of a licensed veterinarian.

[40 FR 13858, Mar. 27, 1975, as amended at 49 FR 32061, Aug. 10, 1984]



Sec.  522.1870  Praziquantel injectable solution.

    (a) Specification. Each milliliter contains 56.8 milligrams of 
praziquantel.
    (b) Sponsors. See 000859 and 059130 in Sec.  510.600(c) of this 
chapter.
    (c) Conditions of use--(1) Dogs--(i) Amount. For dogs 5 pounds and 
under, 0.3 milliliter (17.0 milligrams); for 6 to 10 pounds, 0.5 
milliliter (28.4 milligrams); for 11 to 25 pounds, 1.0 milliliter (56.8 
milligrams); if over 25 Pounds, 0.2 milliliter (11.4 milligrams) per 5 
pounds body weight to a maximum of 3 milliliters (170.4 milligrams).
    (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. For subcutaneous or intramuscular use; not 
intended for use in puppies less than 4 weeks of age; Federal law 
restricts the drug to use by or on the order of a licensed veterinarian.
    (2) Cats--(i) Amount. For cats under 5 pounds, 0.2 milliliter (11.4 
milligrams); 5 to 10 pounds, 0.4 milliliter (22.7 milligrams); 11 pounds 
and over, 0.6 milliliter (34.1 milligrams) maximum.
    (ii) Indications for use. For removal of feline cestodes Dipylidium 
caninum and Taenia taeniaeformis.
    (iii) Limitations. For subcutaneous or intramuscular injection only. 
Not intended for use in kittens less than 6 weeks of age. Federal law 
restricts this 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]



Sec.  522.1881  Sterile prednisolone acetate aqueous suspension.

    (a) Specifications. Each milliliter of sterile aqueous suspension 
contains 25 milligrams of prednisolone acetate.
    (b) Sponsor. See No. 000061 in Sec.  510.600(c) of this chapter.
    (c) NAS/NRC status. The conditions of use are NAS/NRC reviewed and 
found

[[Page 272]]

effective. Applications for these uses need not include effectiveness 
data as specified in Sec.  514.111 of this chapter but may require 
bioequivalency and safety information.
    (d) Conditions of use. (1) 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 
post-operatively and for various stress conditions when corticosteroids 
are required while the animal is being treated for a specific condition.
    (2) The drug is administered to horses intra-articularly at a dosage 
level of 50 to 100 milligrams. The dose may be repeated when necessary. 
If no response is noted after 3 or 4 days, the possibility must be 
considered that the condition is unresponsive to prednisolone therapy. 
The drug is administered to dogs and cats intramuscularly at a dosage 
level of 10 to 50 milligrams. 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 milligrams. The dose may 
be repeated when necessary after 7 days for two or three doses.
    (3) The labeling shall comply with the requirements of Sec.  510.410 
of this chapter for corticosteroids.
    (4) Not for use in horses intended for food.
    (5) Federal law restricts this drug to use by or on the order of a 
licensed veterinarian.

[52 FR 23032, June 17, 1987]



Sec.  522.1883  Prednisolone sodium phosphate injection, sterile.

    (a)(1) Specifications. Each milliliter contains 20 milligrams of 
prednisolone sodium phosphate (equivalent to 14.88 milligrams of 
prednisolone) in sterile aqueous solution.
    (2) Sponsor. See No. 000864 in Sec.  510.600(c) of this chapter.
    (3) Conditions of use--(i) It is used in treatment of dogs when a 
rapid adrenal glucocorticoid and/or anti-inflammatory effect is 
necessary. \1\
    (ii) It is administered intravenously in a dosage of 2\1/2\ to 5 
milligrams of prednisolone sodium phosphate 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. If permanent use is required, oral therapy (tablets) may 
be substituted. If therapy is to be withdrawn after prolonged use, 
reduce daily dose gradually over a number of days.
    (iii) Do not use in viral infections. Except in emergency therapy, 
do not use with tuberculosis, chronic nephritis, Cushing's disease, or 
peptic ulcers. With infections, use appropriate antibacterial therapy 
with, and for at least 3 days after, discontinuance of use and 
disappearance of all signs of infection. \1\
    (iv) Clinical and experimental data have 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.
    (v) Federal law restricts this drug to use by or on the order of a 
licensed veterinarian. \1\
    (b) [Reserved]

[43 FR 29769, July 11, 1978, as amended at 49 FR 23834, June 8, 1984]



Sec.  522.1884  Prednisolone sodium succinate injection.

    (a) Chemical name. 11 beta, 17, 21-Trihydroxypregna-1, 4-diene-3, 
20-dione 21-succinate sodium salt.
    (b) Specifications. Each milliliter of prednisolone sodium succinate 
injection contains: Prednisolone sodium succinate equivalent in activity 
to 10, 20, or 50 milligrams of prednisolone.
    (c) Sponsor. See No. 000009 in Sec.  510.600(c) of this chapter for 
products containing 10, 20, and 50 milligrams equivalent prednisolone 
activity per milliliter for use in horses, dogs, and cats as provided in 
paragraphs (d)(1), (2) (i), (ii), and (iii) of this section.

[[Page 273]]

    (d) Conditions of use. (1) The drug is intended for the treatment of 
horses, dogs, and cats.\1\
---------------------------------------------------------------------------

    \1\ These conditions are NAS/NRC reviewed and found effective. 
Applications for these uses need not include effectiveness data as 
specified by Sec.  514.111 of this chapter, but may require 
bioequivalency and safety information.
---------------------------------------------------------------------------

    (2)(i) The dosage for horses is 50 to 100 milligrams as an initial 
dose given intravenously over a period of one-half to 1 minute, or 
intramuscularly, 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. \1\
    (ii) In dogs, the drug is administered intravenously at a range of 
2.5 to 5 milligrams 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) In dogs and cats, the drug may be given intramuscularly for 
treatment of inflammatory, allergic and less severe stress conditions, 
where immediate effect is not required, at 1 to 5 milligrams ranging 
upward to 30 to 50 milligrams 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.
    (3) Federal law restricts this drug to use by or on the order of a 
licensed veterinarian. \1\

[40 FR 13858, Mar. 27, 1975, as amended at 46 FR 13215, Feb. 20, 1981; 
46 FR 33513, June 30, 1981; 52 FR 25212, July 6, 1987; 66 FR 23588, May 
9, 2001]



Sec.  522.1885  Prednisolone tertiary butylacetate suspension.

    (a) Specifications. Prednisolone tertiary butylacetate (Pregna-1,4-
diene-3, 20-dione-11B, 17[alpha] 21-triol 21-(3,3, dimethyl butyrate) 
suspension contains 20 milligrams of prednisolone tertiary butylacetate 
per milliliter. It is sterile.
    (b) Sponsor. See No. 050604 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use. (1) It is used as an anti-inflammatory agent 
in horses, dogs, and cats.\1\
    (2) It is administered to horses intramuscularly at a dosage level 
of 100 to 300 milligrams and intrasynovially at a dosage level of 50 to 
100 milligrams. It is administered intramuscularly to dogs and cats at a 
dosage level of 1 milligram per 5 pounds of body weight and 
intrasynovially at a dosage level of 10 to 20 milligrams. Intramuscular 
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.\1\
    (3) Clinical and experimental data have demonstrated that 
corticosteroids administered orally or parenterally to animals may 
induce the first stage of parturition when administered late in 
pregnancy and may precipitate premature parturition followed by 
dystocia, fetal death, retained placenta, and metritis.\1\
    (4) Federal law restricts this drug to use by or on the order of a 
licensed veterinarian.\1\

[40 FR 13858, Mar. 27, 1975, as amended at 62 FR 63271, Nov. 28, 1997]



Sec.  522.1890  Sterile prednisone suspension.

    (a) [Reserved]
    (b)(1) Specifications. Each milliliter of sterile aqueous suspension 
contains 10 to 40 milligrams of prednisone.
    (2) Sponsor. See 000061 in Sec.  510.600(c) of this chapter.
    (3) Conditions of use--(i) Amount. Administer intramuscularly as 
follows:
    (a) Horses. 100 to 400 milligrams, repeating if necessary. If no 
response is observed after 3 to 4 days of therapy, reevaluate 
diagnosis.\1\
    (b) Dogs and cats. 0.25 to 1.0 milligram per pound of body weight 
for 3 to 5 days or until a response is noted. Treatment may be continued 
with an orally administered dose.\1\
    (ii) Indications for use. It is used for conditions requiring an 
anti-inflammatory agent.\1\
    (iii) Limitations.\1\ Do not use in viral infections. Except in 
emergency therapy, do not use in animals with tuberculosis, chronic 
nephritis, or

[[Page 274]]

Cushings's disease. With infections, use appropriate antibacterial 
therapy with and for at least 3 days after discontinuance of use and 
disappearance of all signs of infection. Clinical and experimental data 
have 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. Not for use in horses intended for food. Federal 
law restricts this drug to use by or on the order of a licensed 
veterinarian.
---------------------------------------------------------------------------

    \1\ These conditions are NAS/NRC reviewed and deemed effective. 
Applications for these uses need not include effectiveness data as 
specified by Sec.  514.111 of this chapter, but may require 
bioequivalency and safety information.

[45 FR 13446, Feb. 29, 1980, as amended at 50 FR 6160, Feb. 14, 1985; 52 
FR 7832, Mar. 13, 1987]



Sec.  522.1920  Prochlorperazine, isopropamide for injection.

    (a) Specifications. Prochlorperazine, isopropamide for injection, 
veterinary, contains in each milliliter, 6 milligrams of 
prochlorperazine edisylate (equivalent to 4 milligrams 
prochlorperazine), and 0.38 milligrams of isopropamide iodide 
(equivalent to 0.28 milligrams of isopropamide) in buffered aqueous 
solution.
    (b) Sponsor. See No. 000069 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use. (1) The drug is used in dogs and cats in 
which gastrointestinal disturbances are associated with emotional 
stress.
    (2) 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
------------------------------------------------------------------------


Following the last injection, administer prochlorperazine and 
isopropamide sustained release capsules as indicated.
    (3) For use only by or on the order of a licensed veterinarian.

[40 FR 13858, Mar. 27, 1975, as amended at 56 FR 50653, Oct. 8, 1991; 60 
FR 55659, Nov. 2, 1995]



Sec.  522.1940  Progesterone and estradiol benzoate in combination.

    (a) [Reserved]
    (b) Sponsors. See 000856 in Sec.  510.600(c) of this chapter for use 
as in paragraphs (d)(1)(i)(A), (d)(1)(ii), (d)(1)(iii), (d)(2)(i)(A), 
(d)(2)(ii), (d)(2)(iii), and (d)(3) of this section. See 021641 in Sec.  
510.600(c) of this chapter for use as in paragraphs (d)(1) and (d)(2)(i) 
through (d)(2)(iii)(A) of this section.
    (c) Related tolerances. See Sec. Sec.  556.240 and 556.540 of this 
chapter.
    (d) Conditions of use. It is used for implantation in animals as 
follows:
    (1) Suckling beef calves--(i) Amount. (A) 100 milligrams of 
progesterone and 10 milligrams of estradiol benzoate in four pellets per 
implant dose.
    (B) 100 milligrams of progesterone and 10 milligrams of estradiol 
benzoate in four pellets with 29 milligrams of tylosin tartrate as a 
local antibacterial in one pellet per implant dose.
    (ii) Indications for use. Increased rate of weight gain.
    (iii) Limitations. For use in suckling beef calves (at least 45 days 
of age) up to 400 pounds of body weight. For subcutaneous ear 
implantation, one dose per animal. Do not use in bull calves intended 
for reproduction.
    (2) Steers--(i) Amount. (A) 200 milligrams of progesterone and 20 
milligrams estradiol benzoate in eight pellets per implant dose.
    (B) 200 milligrams progesterone and 20 milligrams estradiol benzoate 
in eight pellets with 29 milligrams tylosin tartrate as a local 
antibacterial in one pellet per implant dose.
    (ii) Indications for use. For increased rate of weight gain and 
improved feed efficiency.
    (iii) Limitations. (A) For animals weighing 400 pounds or more; for 
subcutaneous ear implantation, one dose per animal.
    (B) For additional improvement in rate of weight gain in steers fed 
in confinement for slaughter, reimplant at approximately day 70.

[[Page 275]]

    (3) Steers fed in confinement for slaughter--(i) Amount. Reimplant 
200 milligrams of progesterone and 20 milligrams of estradiol benzoate 
on approximately day 70 following an initial implant of 100 milligrams 
of progesterone and 10 milligrams of estradiol benzoate or 200 
milligrams of progesterone and 20 milligrams of estradiol benzoate.
    (ii) Indications for use. For additional improvement in rate of 
weight gain.
    (iii) Limitations. For subcutaneous ear implantation.

[40 FR 13858, Mar. 27, 1975, as amended at 48 FR 48659, Oct. 20, 1983; 
49 FR 13873, Apr. 9, 1984; 51 FR 21746, June 16, 1986; 52 FR 45312, Nov. 
27, 1987; 53 FR 7406, Feb. 21, 1989; 55 FR 13769, Apr. 12, 1990; 59 FR 
49808, Sept. 30, 1994; 61 FR 5507, Feb. 13, 1996; 62 FR 8372, Feb. 25, 
1997; 63 FR 45945, Aug. 28, 1998; 64 FR 48294, Sept. 3, 1999]



Sec.  522.1962  Promazine hydrochloride injection.

    (a) Specifications. Each milliliter of sterile aqueous solution 
contains 50 milligrams of promazine hydrochloride.
    (b) Sponsor. In Sec.  510.600(c) of this chapter, see No. 000008 for 
conditions of use as in paragraph (c)(1)(i) of this section; see No. 
000856 for conditions of use as in paragraph (c)(1)(ii) of this section; 
see No. 000864 for conditions of use as in paragraph (c)(1)(iii) of this 
section.
    (c) Conditions of use. (1)(i) To horses either intramuscularly or 
intravenously at a dosage of 0.2 to 0.5 milligram per pound of body 
weight, and to dogs and cats 1 to 3 milligrams per pound of body weight, 
every 4 to 6 hours as a tranquilizer or preanesthetic.\1\
---------------------------------------------------------------------------

    \1\ These conditions are NAS/NRC reviewed and found effective. 
Applications for these uses need not include effectiveness data as 
specified by Sec.  514.111 of this chapter, but may require 
bioequivalency and safety information.
---------------------------------------------------------------------------

    (ii) To horses either intramuscularly or intravenously at a dosage 
of 0.2 to 0.5 milligram per pound of body weight, and to dogs and cats 
at 1 to 2 milligrams per pound of body weight, every 4 to 6 hours as a 
tranquilizer, preanesthetic, for minor operative procedures in 
conjunction with local anesthesia, as adjunctive therapy for tetanus, 
and as an antiemetic in dogs and cats prior to worming, or to prevent 
motion sickness in dogs.\1\
    (iii) To horses intravenously at a dosage of 0.2 to 0.5 milligram 
per pound of body weight, as a tranquilizer and preanesthetic, as 
required.\1\
    (2) Not for use in conjunction with organophosphates because their 
toxicity may be potentiated, nor with procaine hydrochloride as its 
activity may be increased.\1\
    (3) Not for use in horses intended for food.\1\
    (4) Federal law restricts this drug to use by or on the order of a 
licensed veterinarian.\1\

[46 FR 18962, Mar. 27, 1981]



Sec.  522.2002  Propiopromazine hydrochloride injection.

    (a) Chemical name. 1-Propanone, 1-[10-[3-(dimethylamino) propyl] 
phenothiazine-2-yl]-, monohydrochloride.
    (b) Specifications. Propiopromazine hydrochloride injection contains 
5 or 10 milligrams of the drug in each milliliter of sterile aqueous 
solution.
    (c) Sponsor. See No. 000856 in Sec.  510.600(c) of this chapter.
    (d) Conditions of use. (1) It is administered either intravenously 
or intramuscularly to dogs and cats for tranquilization at a dosage 
level of 0.05-0.5 milligram per pound of body weight and is also 
administered intravenously to dogs and cats as a preanesthetic at a 
dosage level of 0.25 milligram per pound of body weight.
    (2) It is not to be used in conjunction with organophosphates and/or 
procaine hydrochloride since phenothiazines may potentiate the toxicity 
of organophosphates and the activity of procaine hydrochloride.
    (3) For use only by or on the order of a licensed veterinarian.

[40 FR 13858, Mar. 27, 1975, as amended at 46 FR 60570, Dec. 11, 1981; 
61 FR 5507, Feb. 13, 1996]



Sec.  522.2005  Propofol injection.

    (a) Specifications. The drug is a sterile, nonpyrogenic, oil-in-
water emulsion containing 10 milligrams of propofol per milliliter.
    (b) Sponsor. See No. 000061 in Sec.  510.600(c) of this chapter for 
use as in

[[Page 276]]

paragraphs (c)(1) and (c)(2) of this section. See No. 000074 in Sec.  
510.600(c) of this chapter for use as in paragraph (c)(1) of this 
section.
    (c) Conditions of use--(1) Dogs. (i) The drug is indicated for use 
as an anesthetic as follows: As a single injection to provide general 
anesthesia for procedures lasting up to 5 minutes; 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) The drug is administered by intravenous injection as follows: 
For induction of general anesthesia without the use of preanesthetics 
the dosage is 5.5 to 7.0 milligrams per kilogram (2.5 to 3.2 milligrams 
per pound); for the maintenance of general anesthesia without the use of 
preanesthetics the dosage is 1.1 to 3.3 milligrams per kilogram (0.5 to 
1.5 milligrams per pound). The use of preanesthetic medication reduces 
propofol dose requirements.
    (iii) Adequate data concerning safe use of propofol in pregnant and 
breeding dogs have not been obtained. Doses may need adjustment for 
geriatric or debilitated patients. Federal law restricts this drug to 
use by or on the order of a licensed veterinarian.
    (2) Cats. (i) The drug is indicated for use as an anesthetic as 
follows: As a single injection to provide general anesthesia for short 
procedures, for induction and maintenance of general anesthesia using 
incremental doses to effect, and for induction of general anesthesia 
where maintenance is provided by inhalant anesthetics.
    (ii) The drug is administered by intravenous injection as follows: 
For induction of general anesthesia without the use of preanesthetics 
the dosage is 8.0 to 13.2 milligrams per kilogram (3.6 to 6.0 milligrams 
per pound). For the maintenance of general anesthesia without the use of 
preanesthetics the dosage is 1.1 to 4.4 milligrams per kilogram (0.5 to 
2.0 milligrams per pound). The use of preanesthetic medication reduces 
propofol dose requirements.
    (iii) Adequate data concerning safe use of propofol in pregnant and 
breeding cats have not been obtained. Doses may need adjustment for 
geriatric or debilitated patients. Federal law restricts this drug to 
use by or on the order of a licensed veterinarian.

[61 FR 66582, Dec. 18, 1996, as amended at 62 FR 61625, Nov. 19, 1997; 
63 FR 24420, May 4, 1998; 64 FR 13510, Mar. 19, 1999]



Sec.  522.2012  Prostalene solution.

    (a) Specifications. Each milliliter of sterile solution contains 1 
milligram of prostalene.
    (b) Sponsor. No. 000856 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use--Horses. (1) It is used in mares for the 
control of estrus.
    (2) It is administered at a dose of 5 micrograms per kilogram of 
body weight as a single subcutaneous injection.
    (3) Not for use in horses intended for food.
    (4) Federal law restricts this drug to use by or on the order of a 
licensed veterinarian.

[41 FR 26854, June 30, 1976, as amended at 61 FR 5507, Feb. 13, 1996]



Sec.  522.2063  Pyrilamine maleate injection.

    (a) Specifications. The drug is a sterile aqueous solution with each 
milliliter containing 20 milligrams of pyrilamine maleate.
    (b) Sponsors. See No. 000061 in Sec.  510.600(c) of this chapter for 
uses in paragraph (c)(2)(i) of this section; see No. 000864 in Sec.  
510.600(c) of this chapter for uses in paragraph (c)(2)(ii) of this 
section.
    (c) Conditions of use. (1) It is intended for treating horses in 
conditions in which antihistaminic therapy may be expected to lead to 
alleviation of some signs of disease.\1\
---------------------------------------------------------------------------

    \1\ These conditions are NAS/NRC reviewed and found effective. 
Applications for these uses need not include effectiveness data as 
specified by Sec.  514.111 of this chapter, but may require 
bioequivalency and safety information.
---------------------------------------------------------------------------

    (2)(i) It is administered intramuscularly, subcutaneously, or 
intravenously. Local injection at the site of insect bites may be 
indicated in severe cases. Intravenous injections must be given slowly 
to avoid symptoms of overdosage. Dosage may be repeated every 6 to 12 
hours whenever necessary. Horses, 40 to 60 milligrams

[[Page 277]]

per 100 pounds body weight; foals, 20 milligrams per 100 pounds body 
weight.\1\
    (ii) It is administered intravenously. Intravenous injections must 
be given slowly to avoid symptoms of overdosage. Dosage may be repeated 
every 6 to 12 hours if necessary. Horses, 40 to 60 milligrams per 100 
pounds body weight; foals, 20 milligrams per 100 pounds body weight.\1\
    (3) Do not use in horses intended for food purposes.\1\
    (4) Federal law restricts this drug to use by or on the order of a 
licensed veterinarian.\1\

[40 FR 13858, Mar. 27, 1975; 41 FR 9150, Mar. 3, 1976, as amended at 42 
FR 13549, Mar. 11, 1977; 42 FR 61256, Dec. 2, 1977; 51 FR 41477, Nov. 
17, 1986; 52 FR 7832, Mar. 13, 1987; 54 FR 1164, Jan. 12, 1989]



Sec.  522.2100  Selenium, vitamin E injection.

    (a)(1) Specifications. The drug is an emulsion containing in each 
milliliter, 5.48 milligrams sodium selenite (equivalent to 2.5 
milligrams selenium), 50 milligrams 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. (i) The drug is intended for use for the 
prevention and treatment of selenium-tocopherol deficiency syndrome in 
horses.
    (ii) The drug is administered by intravenous or deep intramuscular 
injection in divided doses in 2 or more sites in the gluteal or cervical 
muscles at a dosage level of 1 milliliter per 100 pounds of body weight 
and may be repeated at 5 to 10 day intervals.
    (iii) Do not use in horses intended for food.
    (iv) Federal law restricts this drug to use by or on the order of a 
licensed veterinarian.
    (b)(1) Specifications. The drug contains in each milliliter 2.19 
milligrams of sodium selenite (equivalent to 1 milligram of selenium), 
50 milligrams 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. (i) The drug is intended for use as an aid in 
alleviating and controlling inflammation, pain and lameness associated 
with certain arthropathies in dogs.
    (ii) The drug is administered subcutaneously or intramuscularly in 
divided doses in 2 or more sites at a dosage level of 1 milliliter per 
20 pounds of body weight with a minimum dosage of \1/4\ milliliter and a 
maximum dosage of 5 milliliters. The dosage is repeated at 3 day 
intervals until a satisfactory therapeutic response is observed. A 
maintenance regimen is then initiated which consists of 1 milliliter per 
40 pounds of body weight with a minimum dosage of \1/4\ milliliter 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.
    (iii) 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 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.

[[Page 278]]

    (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) Sponsor. See Nos. 000061 and 000856 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]



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. 059945 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use--(1) Amount. Inject 500 mg every 14 days 
beginning during the 9th or 10th week (57 to 70 days) after calving and 
continue until the end of lactation.
    (2) Indications for use. For use in healthy lactating dairy cows to 
increase the production of marketable milk.
    (3) Limitations. For use in lactating dairy cows only. Safety to 
replacement bulls born to treated dairy cows has not been established. 
Administer subcutaneously. To minimize injection site blemishes on 
carcass at time of slaughter, avoid injections within 2 weeks of 
expected slaughter. No milk discard or preslaughter withdrawal period is 
required. Use may result in reduced pregnancy rates and, in first calf 
heifers, an increase in days open. The incidence of retained placenta 
may be higher. Treated cows are at an increased risk for clinical 
mastitis and subclinical mastitis. In some herds, use has been 
associated with increases in somatic cell counts in milk. Care should be 
taken to differentiate increased body temperature due to use of this 
product from an increased body temperature that may occur due to 
illness. Use may result in an increase in digestive disorders such as 
indigestion, bloat, and diarrhea. There may be an increase in the number 
of cows experiencing periods of ``off-feed'' (reduced feed intake) 
during treatment. Cows treated with this product may have increased 
numbers of enlarged hocks and lesions of the knee (carpal region), and 
second lactation or older cows may have more disorders of the foot 
region. Use has been associated with reductions in hemoglobin and 
hematocrit values during treatment. Human warning: Avoid prolonged or 
repeated contact with eyes and skin.

[58 FR 59947, Nov. 12, 1993, as amended at 67 FR 18085, Apr. 15, 2002]



Sec.  522.2120  Spectinomycin dihydrochloride injection.

    (a) Specifications. The spectinomycin dihydrochloride pentahydrate 
used in manufacturing the drug is the antibiotic substance produced by 
the growth of Streptomyces flavopersicus

[[Page 279]]

(var. Abbott) or the same antibiotic substance produced by any other 
means. Each milliliter of the drug contains the following amount of 
spectinomycin activity from spectinomycin dihydrochloride pentahydrate:
    (1) 5 milligrams when used as provided in paragraph (d)(1) of this 
section.
    (2) [Reserved]
    (3) 100 milligrams when used as provided in paragraphs (d) (2), (3), 
and (4) of this section.
    (b) Sponsor. In Sec.  510.600 of this chapter, see No. 059130 for 
conditions of use as in paragraph (d) of this section, and see No. 
000009 for conditions of use as in paragraph (d)(2) and (d)(4) of this 
section.
    (c) Special considerations. The quantity of spectinomycin referred 
to in this section refers to the equivalent weight of base activity for 
the drug.
    (d) Conditions of use. It is administered as spectinomycin 
dihydrochloride pentahydrate as follows:
    (1) Subcutaneously in the treatment of 1-to-3-day-old turkey poults 
at the rate of 1 to 2 milligrams per poult as an aid in the prevention 
of mortality associated with Arizona group infection.
    (2) Subcutaneously in the treatment of 1-to-3-day old:
    (i) Turkey poults at the rate of 5 milligrams per poult as an aid in 
the control of chronic respiratory disease (CRD) associated with E. 
coli.
    (ii) Baby chicks at the rate of 2.5 to 5 milligrams per chick as an 
aid in the control of mortality and to lessen severity of infections 
caused by M. synoviae, S. typhimurium, S. infantis, and E. coli.
    (3) Intramuscularly in the treatment of dogs:
    (i) At a dosage level of 2.5 milligrams to 5.0 milligrams per pound 
of body weight twice daily. Treatment may be continued for 4 days. For 
treatment of infections caused by gram-negative and gram-positive 
organisms susceptible to spectinomycin.
    (ii) Federal law restricts this drug to use by or on the order of a 
licensed veterinarian.
    (4) Administer single injection of 0.1 milliliter (10 milligrams) 
subcutaneously in nape of neck of 1- to 3-day-old turkey poults as an 
aid in control of airsacculitis associated with M. meleagridis sensitive 
to spectinomycin.

[40 FR 13858, Mar. 27, 1975, as amended at 43 FR 9273, Mar. 7, 1978; 46 
FR 18964, Mar. 27, 1981; 47 FR 14149, Apr. 2, 1982; 61 FR 5507, Feb. 13, 
1996; 61 FR 31028, June 19, 1996; 65 FR 45877, July 26, 2000; 66 FR 
22118, May 3, 2001]



Sec.  522.2121  Spectinomycin sulfate solution.

    (a) Specifications. Each milliliter of sterile aqueous solution 
contains spectinomycin sulfate tetrahydrate equivalent to 100 milligrams 
of spectinomycin.
    (b) Sponsor. See 000009 in Sec.  510.600(c) of this chapter.
    (c) Related tolerances. See Sec.  556.600 of this chapter.
    (d) Conditions of use--(1) Cattle--(i) Dose. 10 to 15 milligrams per 
kilogram of body weight, at 24-hour intervals for 3 to 5 consecutive 
days.
    (ii) Indications for use. For the treatment of bovine respiratory 
disease (pneumonia) associated with Pasteurella haemolytica, P. 
multocida, and Haemophilus somnus.
    (iii) Limitations. For subcutaneous injection in the neck. Do not 
inject more than 50 milliliters at each site. 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 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.
    (2) [Reserved]

[63 FR 24107, May 1, 1998]



Sec.  522.2150  Stanozolol sterile suspension.

    (a) Specifications. Each milliliter of sterile suspension contains 
50 milligrams of stanozolol.
    (b) Sponsor. No. 000009 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use. (1) Used as an anabolic steroid treatment in 
dogs, cats, and horses.
    (2) Administered to dogs and cats by deep intramuscular injection in 
the thigh at weekly intervals, for several

[[Page 280]]

weeks. For cats and small breeds of dogs, 25 milligrams. For larger 
dogs, 50 milligrams.
    (3) Administered to horses by deep intramuscular injection in the 
gluteal region at weekly intervals, for not more than 4 weeks; 25 
milligrams per 100 pounds of body weight.
    (4) Not for use in horses intended for food.
    (5) Federal law restricts this drug to use by or on the order of a 
licensed veterinarian.

[40 FR 46101, Oct. 6, 1975, as amended at 42 FR 36995, July 19, 1977; 55 
FR 23076, June 6, 1990]



Sec.  522.2200  Sulfachlorpyridazine.

    (a) Chemical name. N\1\-(6-Chloro-3-pyridazinyl) sulfanilamide.
    (b) Specifications. Melting point range 190 [deg]C to 191 [deg]C.
    (c) Sponsor. See No. 053501 in Sec.  510.600(c) of this chapter.
    (d) Related tolerances. See Sec.  556.630 of this chapter.
    (e) Conditions of use. It is used for injection into calves as 
follows:
    (1) Amount. 30 to 45 milligrams per pound of body weight per day.
    (2) Indications for use. Treatment of diarrhea caused or complicated 
by E. coli (colibacillosis).
    (3) Limitations. Administer as the sodium salt of 
sulfachlorpyridazine intravenously in aqueous solution for 1 to 5 days 
in divided doses twice daily; treated calves must not be slaughtered for 
food during treatment or for 5 days after the last treatment.

[40 FR 13858, Mar. 27, 1975, as amended at 50 FR 41489, Oct. 11, 1985]



Sec.  522.2220  Sulfadimethoxine injection.

    (a)(1) Specifications. Sulfadimethoxine injection containing 400 
milligrams per milliliter.
    (2) Sponsor. (i) See No. 000069 in Sec.  510.600(c) of this chapter 
for conditions of use as in paragraphs (a)(3)(i) through (a)(3)(iii) of 
this section.
    (ii) See No. 057561 for conditions of use as in paragraph (a)(3) of 
this section.
    (iii) See No. 059130 for use as in paragraph (a)(3)(iii) of this 
section.
    (3) Conditions of use. (i) It is used or intended for use in dogs 
and cats as follows:
    (a) 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.
    (b) It is administered by intravenous or subcutaneous injection at 
an initial dose of 55 milligrams per kilogram of body weight followed by 
27.5 milligrams per kilogram of body weight every 24 hours.
    (c) Federal law restricts this drug to use by or on the order of a 
licensed veterinarian.
    (ii) It is used or intended for use in horses as follows:
    (a) For the treatment of respiratory disease caused by Streptococcus 
equi (strangles).
    (b) It is administered by intravenous injection at an initial dose 
of 55 milligrams per kilogram of body weight followed by 27.5 milligrams 
per kilogram of body weight every 24 hours until the patient is 
asymptomatic for 48 hours.
    (c) Not for use in horses intended for food.
    (d) Federal law restricts this drug to use by or on the order of a 
licensed veterinarian.
    (iii) It is used or intended for use in cattle as follows:
    (a) For the treatment of shipping fever complex, bacterial 
pneumonia, calf diphtheria, and foot-rot.
    (b) It is administered by intravenous injection at an initial dose 
of 25 milligrams per pound of body weight followed by 12.5 milligrams 
per pound of body weight every 24 hours until the animal is asymptomatic 
for 48 hours.
    (c) 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.
    (d) Tissue damage may result from perivascular infiltration.
    (b) [Reserved]
    (c)(1) Specifications. Sulfadimethoxine containing 100 milligrams 
per milliliter.
    (2) Sponsor. See No. 000010 in Sec.  510.600(c) of this chapter.

[[Page 281]]

    (3) Conditions of use. (i) It is used or intended for use in the 
treatment of sulfadimethoxine-susceptible bacterial infections in dogs.
    (ii) It is administered by subcutaneous, intramuscular, or 
intravenous injection at an initial dose of 25 milligrams per pound of 
body weight followed by 12.5 milligrams per pound of body weight every 
24 hours thereafter. Continue treatment until the animal is free from 
symptoms for 48 hours.
    (iii) For use by or on the order of a licensed veterinarian.
    (d) Related tolerances. See Sec.  556.640 of this chapter.

[40 FR 13858, Mar. 27, 1975, as amended at 40 FR 34112, Aug. 14, 1975; 
40 FR 42007, Sept. 10, 1975; 50 FR 254, Jan. 3, 1985; 53 FR 40728, Oct. 
18, 1988; 54 FR 30205, July 19, 1989; 58 FR 38972, July 21, 1993; 59 FR 
56000, Nov. 10, 1994; 61 FR 4875, Feb. 9, 1996; 62 FR 23128, Apr. 29, 
1997; 62 FR 35076, June 30, 1997]



Sec.  522.2240  Sulfaethoxypyridazine.

    (a) Chemical name. N\1\-(6-Ethoxy-3-pyridazinyl) sulfanilamide.
    (b) Specifications. Melting point range of 180 [deg]C to 186 [deg]C.
    (c) Sponsor. See No. 053501 in Sec.  510.600(c) of this chapter.
    (d) Related tolerances. See Sec.  556.650 of this chapter.
    (e) Conditions of use. It is used for injection into cattle as 
follows:
    (1) Amount. 2.5 grams per 100 pounds of body weight per day.
    (2) Indications for use. Treatment of respiratory infection 
(pneumonia, shipping fever), foot rot, calf scours; as adjunctive 
therapy in septicemia accompanying mastitis and metritis.
    (3) Limitations. Administer intravenously for not more than 4 days; 
or first treatment may be followed by 3 days of treatment with 
sulfaethoxypyridazine in drinking water, feed, or tablet in accordance 
with Sec.  558.579(e) or Sec. Sec.  520.2240a(e) and 520.2240b(e) of 
this chapter; as sodium sulfaethoxypyridazine; do not treat within 16 
days of slaughter; as sole source of sulfonamide; 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; for use by or on the 
order of a licensed veterinarian.

[40 FR 13858, Mar. 27, 1975, as amended at 41 FR 11011, Mar. 15, 1976; 
67 FR 78355, Dec. 24, 2002]



Sec.  522.2260  Sulfamethazine injectable solution.

    (a) Specifications. Each milliliter of sterile aqueous solution 
contains 250 milligrams of sulfamethazine sodium.
    (b) Sponsor. See No. 053501 in Sec.  510.600(c) of this chapter.
    (c) Related tolerances. See Sec.  556.670 of this chapter.
    (d) NAS/NRC status. The conditions of use are NAS/NRC reviewed and 
found effective. Applications for these uses need not include 
effectiveness data as specified by Sec.  514.111 of this chapter, but 
may require bioequivalency and safety information.
    (e) Conditions of use--(1) Amount. 20 milliliters for each 50 pounds 
of body weight (100 milligrams per pound) initially, 20 milliliters per 
100 pounds of body weight (50 milligrams per pound) daily thereafter for 
cattle.
    (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. For intravenous use only. Not for use in lactating 
dairy animals. Withdraw medication from cattle 10 days prior to 
slaughter for food. If symptoms persist for 2 or 3 days, consult a 
veterinarian. Adequate water intake is important for animals treated 
with sulfonamides. Treatment should continue 24 to 48 hours beyond the 
remission of disease symptoms, but not to exceed a total of 5 
consecutive days.

[46 FR 62055, Dec. 22, 1981, as amended at 67 FR 78355, Dec. 24, 2002]



Sec.  522.2340  Sulfomyxin.

    (a) Specifications. Sulfomyxin for injection is sterile. It is 
derived from the antibiotic substance produced by the

[[Page 282]]

growth of Bacillus polymyxa or is the same substance produced by any 
other means.
    (b) Sponsor. See No. 000069 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
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.



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. 000856 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.



Sec.  522.2424  Sodium thiamylal for injection.

    (a) Specifications. The drug is a sterile dry powder. It is 
reconstituted aseptically 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 code Nos. 000010 and 000856 in Sec.  510.500(c) of 
this chapter.
    (c) Conditions of use. (1) It is used as an ultra-short-acting 
anesthetic in dogs, cats, swine, horses, and cattle.
    (2) When diluted aseptically to the desired concentration and 
administered intravenously to effect, the average single dose is:
    (i) Dogs and cats: 8 milligrams per pound of body weight (when used 
with a preanesthetic, generally one-half the normal dose).
    (ii) Swine: 40 milligrams per 5 pounds of body weight.
    (iii) Horses: Light anesthesia, 1 gram per 500 pounds to 1,100 
pounds of body weight; deep anethesia, 1 gram per 300 pounds of body 
weight (40 milligrams per 12 pounds of body weight).
    (iv) Cattle: Short duration, 20 milligrams per 5 pounds of body 
weight; longer duration, 40 milligrams per 7 pounds of body weight.
    (3) Federal law restricts this drug to use by or on the order of a 
licensed veterinarian.
    (4) NAS/NRC status: The conditions of use specified in this 
paragraph are NAS/NRC reviewed and found effective. Applications for 
these uses need not include effectiveness data as specified in

[[Page 283]]

Sec.  514.111 of this chapter, but may require bioequivalency and safety 
information.

[40 FR 25812, June 19, 1975, as amended at 49 FR 8434, Mar. 7, 1984; 53 
FR 23390, June 22, 1988; 53 FR 40728, Oct. 18, 1988; 62 FR 35076, June 
30, 1997]



Sec.  522.2444  Sodium thiopental implantation or injectable dosage forms.



Sec.  522.2444a  Sodium thiopental for injection.

    (a) Specifications. The drug contains sodium thiopental sterile 
powder for dilution with sterile water for injection.
    (b) Sponsor. See No. 000856 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use. (1) It is used as an anesthetic for 
intravenous administration to dogs and cats during short to moderately 
long surgical and other procedures. It is also used to induce anesthesia 
in dogs and cats which then have surgical anesthesia maintained by use 
of a volatile anesthetic.
    (2) It is administered as follows:
    (i) For brief anesthesia (6 to 10 minutes) a dosage of 6 to 9 
milligrams per pound of body weight is suggested.
    (ii) To obtain anesthesia of 15 to 25 minutes duration the suggested 
dosage is 10 to 12 milligrams per pound of body weight.
    (iii) Use of a preanesthetic tranquilizer or morphine will decrease 
the dosage of sodium thiopental required, provide for smoother induction 
and smoother recovery, and sometimes prolong the recovery period. If 
morphine is used as a preanesthetic agent the dose of the barbiturate 
can be reduced as much as 40 to 50 percent. When a tranquilizer is 
administered the barbiturate dosage can be reduced 10 to 25 percent.
    (3) Federal law restricts this drug to use by or on the order of a 
licensed veterinarian.



Sec.  522.2444b  Sodium thiopental, sodium pentobarbital for injection.

    (a) Specifications. Each gram of the drug contains 750 milligrams of 
sodium thiopental and 250 milligrams of sodium pentobarbital sterile 
powder for dilution with sterile water for injection.
    (b) Sponsor. See No. 061623 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use. (1) It is used as an anesthetic for 
intravenous administration to dogs and cats during short to moderately 
long surgical procedures.
    (2) It is administered as follows:
    (i) For total anesthesia, it is given at approximately 10 to 12 
milligrams per pound of body weight over a period of 3.5 to 5 minutes.
    (ii) When preanesthetic medication is used, it is important to 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.
    (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 47 FR 14149, Apr. 2, 1982; 66 
FR 14073, Mar. 9, 2001; 68 FR 4915, Jan. 31, 2003]



Sec.  522.2470  Tiletamine hydrochloride and zolazepam hydrochloride for injection.

    (a) Specifications. Tiletamine hydrochloride and zolazepam 
hydrochloride for injection when reconstituted with sterile distilled 
water provides tiletamine hydrochloride and zolazepam hydrochloride 
equivalent to 50 milligrams of tiletamine base and 50 milligrams of 
zolazepam base per milliliter of solution.
    (b) Sponsor. See No. 000856 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use--(1) Indications for use. It is used for 
restraint or for anesthesia combined with muscle relaxation in cats and 
in dogs for restraint and minor procedures of short duration (30 
minutes) requiring mild to moderate analgesia.
    (2) Amount. Expressed as milligrams of the drug combination:
    (i) In healthy dogs: An initial intramuscular dosage of 3 to 4.5 
milligrams per pound of body weight for diagnostic purposes; 4.5 to 6 
milligrams per pound 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

[[Page 284]]

total dose given should not exceed 12 milligrams per pound of body 
weight. The maximum total safe dose is 13.6 milligrams per pound of body 
weight.
    (ii) In healthy cats: An initial intramuscular dosage of 4.4 to 5.4 
milligrams per pound 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 milligrams per pound 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 milligrams per pound 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 milligrams per pound of body weight.
    (3) Limitations. Discard unused reconstituted solution after 48 
hours. Not for use in dogs and cats with pancreatic disease, or with 
severe cardiac or pulmonary dysfunction. Not for use in pregnant 
animals. Not for use in cats suffering with renal insufficiency. The 
dosage should be reduced in geriatric dogs and cats. Federal law 
restricts this drug to use by or on the order of a licensed 
veterinarian.

[47 FR 15328, Apr. 9, 1982, as amended at 51 FR 24142, July 2, 1986; 67 
FR 67521, Nov. 6, 2002]



Sec.  522.2471  Tilmicosin.

    (a) Specifications. Each milliliter of solution contains 300 
milligrams (mg) tilmicosin base as tilmicosin phosphate.
    (b) Sponsor. See No. 000986 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 mg per kilogram 
(kg) body weight as a single subcutaneous injection.
    (ii) Indications for use. For the treatment of bovine respiratory 
disease (BRD) associated with Mannheimia (Pasteurella) haemolytica. For 
the control of respiratory disease in cattle at high risk of developing 
BRD associated with Mannheimia (P.) 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 28 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]



Sec.  522.2474   Tolazoline hydrochloride injection.

    (a) Specifications. Each milliliter of sterile aqueous solution 
contains tolazoline hydrochloride equivalent to 100 milligrams of base 
activity.
    (b) Sponsor. See No. 061690 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use. It is used as follows:
    (1) Horses--(i) Amount. Administer slowly by intravenous injection 4 
milligrams per kilogram of body weight or 1.8 milligrams per pound (4 
milliliters per 100 kilograms or 4 milliliters per 220 pounds).
    (ii) Indications for use. For use in horses when it is desirable to 
reverse the effects of sedation and analgesia caused by xylazine.
    (iii) Limitations. The safety of TolazineTM has not been 
established in pregnant mares, lactating mares, horses intended for 
breeding, foals, or horses with metabolically unstable conditions. The 
safety of TolazineTM has not been evaluated for reversing 
xylazine used as a preanesthetic to a general anesthetic. This drug is 
for use in horses only and not for use in food-

[[Page 285]]

producing animals. Users with cardiovascular disease (for example, 
hypertension or ischemic heart disease) should take special precautions 
to avoid accidental exposure to this product.

Accidental spillage on the skin should be washed off immediately with 
soap and water. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.
    (2) [Reserved]

[61 FR 25785, May 23, 1996]



Sec.  522.2476  Trenbolone acetate.

    (a) [Reserved]
    (b) Sponsors. See sponsors in Sec.  510.600(c) of this chapter for 
use as in paragraph (d) of this section.
    (1) No. 021641 for use as in paragraphs (d)(1) and (d)(2) of this 
section.
    (2) No. 057926 for use as in paragraphs (d)(1)(i)(A), (d)(1)(ii), 
(d)(1)(iii), (d)(2)(i)(A), (d)(2)(ii), and (d)(2)(iii) of this section.
    (c) Related tolerances. See Sec.  556.739 of this chapter.
    (d) 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.
    (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.

[66 FR 47961, Sept. 17, 2001]



Sec.  522.2477  Trenbolone acetate and estradiol.

    (a) [Reserved]
    (b) Sponsors. See sponsors in Sec.  510.600(c) of this chapter for 
uses as in paragraph (d) of this section.
    (1) No. 021641 for use as in paragraphs (d)(1)(i)(A), (d)(1)(i)(B), 
(d)(1)(ii), (d)(1)(iii), (d)(2)(i)(A), (d)(2)(ii)(A), (d)(2)(iii), and 
(d)(3) of this section.
    (2) No. 057926 for use as in paragraphs (d)(1)(i)(A), (d)(1)(i)(C), 
(d)(1)(i)(D), (d)(1)(ii), (d)(1)(iii), (d)(2), (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.
    (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.
    (D) 80 mg trenbolone acetate and 16 mg estradiol (one implant 
consisting of 4 pellets), or 120 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.

[[Page 286]]

    (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 paragraphs (d)(2)(ii)(A) and 
(d)(2)(ii)(B) of this section.
    (B) 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.
    (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 for use as in paragraph 
(d)(2)(ii)(A) of this section.
    (ii) Indications for use. (A) For increased rate of weight gain and 
improved feed efficiency.
    (B) For increased rate of weight gain.
    (iii) Limitations. Implant subcutaneously in ear only. Do not use in 
animals intended for subsequent breeding or in dairy animals.
    (3) Pasture cattle (slaughter, stocker, 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. Implant subcutaneously in ear only. Not for use 
in animals intended for subsequent breeding or in dairy animals.

[60 FR 4376, Jan. 23, 1995, as amended at 61 FR 29480, June 11, 1996; 61 
FR 41499, Aug. 9, 1996; 62 FR 28629, May 27, 1997; 64 FR 42597, Aug. 5, 
1999; 64 FR 48294, Sept. 3, 1999; 65 FR 10706, Feb. 29, 2000; 65 FR 
26748, May 9, 2000; 65 FR 45879, July 26, 2000; 65 FR 70663, Nov. 27, 
2000; 66 FR 47961, Sept. 17, 2001; 67 FR 5724, Feb. 7, 2002; 67 FR 
78358, Dec. 24, 2002]



Sec.  522.2478  Trenbolone acetate and estradiol benzoate.

    (a) Specifications. Each implant dose consists of:
    (1) 8 pellets, each pellet containing 25 milligrams (mg) trenbolone 
acetate and 3.5 mg estradiol benzoate.
    (2) 4 pellets, each pellet containing 25 mg trenbolone acetate and 
3.5 mg estradiol benzoate.
    (b) Sponsor. See No. 000856 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) 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.
    (ii) For an implant as described in paragraph (a)(2) 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.
    (2) Heifers fed in confinement for slaughter--(i) Amount. 200 mg 
trenbolone acetate and 28 mg estradiol benzoate (as described in 
paragraph (a)(1) of this section).
    (ii) Indications for use. For increased rate of weight gain.
    (iii) Limitations. Implant subcutaneously in ear only. Not for dairy 
or beef replacement heifers.

[67 FR 78972, Dec. 27, 2002]

[[Page 287]]



Sec.  522.2483  Sterile triamcinolone acetonide suspension.

    (a) Specifications. Each milliliter of suspension contains 2 or 6 
milligrams triamcinolone acetonide.
    (b) Sponsor. See 000010 and 053501 in Sec.  510.600(c) of this 
chapter.
    (c) Conditions of use--(1) Amount--(i) Dogs and cats--(a) 
Intramuscular or subcutaneous. Single injection of 0.05 to 0.1 milligram 
(mg.) per pound of body weight in inflammatory, arthritic, or allergic 
disorders. Single injection of 0.1 mg. per pound of body weight in 
dermatologic disorders. If symptoms recur, the dose may be repeated, or 
oral corticosteroid therapy may be instituted. \1\
    (b) Intralesional. 1.2 to 1.8 mg., divided in several injections, 
spaced around the lesion at 0.5 to 2.5 centimeters apart depending on 
the 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. Single injection of 1 to 3 
mg. dose, dependent on size of 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) Horses--(a) Intramuscular or subcutaneous. Single injection of 
0.01 to 0.02 mg. per pound of body weight. Usual dose, 12 to 20 mg.
    (b) Intra-articular and intrasynovial. Single injection of 6 to 18 
mg. dose, dependent on size of 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.
    (2) Indications for use. Treatment of inflamation and related 
disorders in dogs, cats, and horses; \1\ and management and treatment of 
acute arthritis and allergic and dermatologic disorders in dogs and 
cats.
---------------------------------------------------------------------------

    \1\ These conditions are NAS/NRC reviewed and are deemed effective. 
Applications for these uses need not include the effectiveness data 
specified by Sec.  514.111 of this chapter, but may require 
bioequivalency and safety information.
---------------------------------------------------------------------------

    (3) Limitations. (i) Do not use in viral infections. With bacterial 
infections, appropriate antibacterial therapy should be used.
    (ii) Do not use in animals with tuberculosis, chronic nephritis, or 
cushingoid syndrome, except for emergency therapy.
    (iii) Not for use in horses intended for food.
    (iv) Clinical and experimental data have 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.
    (v) Do not use in the treatment of laminitis.
    (vi) Intra-articular injection in equine leg injuries may produce 
osseous metaplasia.
    (vii) Federal law restricts this drug to use by or on the order of a 
licensed veterinarian.

[43 FR 4976, Feb. 7, 1978, as amended at 50 FR 41490, Oct. 11, 1985; 52 
FR 1903, Jan. 16, 1987; 53 FR 40728, Oct. 18, 1988; 62 FR 35077, June 
30, 1997]

[[Page 288]]



Sec.  522.2582  Triflupromazine hydrochloride injection.

    (a) Specifications. Triflupromazine hydrochloride injection contains 
20 milligrams of triflupromazine hydrochloride in each milliliter of 
sterile aqueous solution.
    (b) Sponsor. See No. 053501 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use. (1) The drug is used 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.\1\
    (2) The drug is administered to dogs either intravenously at a 
dosage level of 0.5 to 1 milligram per pound of body weight daily, or 
intramuscularly at a dosage level of 1 to 2 milligrams per pound of body 
weight daily. It is administered to cats intramuscularly at a dosage 
level of 2 to 4 milligrams per pound of body weight daily. It is 
administered to horses intravenously or intramuscularly at a dosage 
level of 10 to 15 milligrams per 100 pounds of body weight daily to a 
maximum dose of 100 milligrams. \1\
---------------------------------------------------------------------------

    \1\ These conditions are NAS/NRC reviewed and are deemed effective. 
Applications for these uses need not include the effectiveness data 
specified by Sec.  514.111 of this chapter, but may require 
bioequivalency and safety information.
---------------------------------------------------------------------------

    (3) Not for use in horses intended for food. \1\
    (4) Do not use in conjunction with organophosphates and/or procaine 
hydrochloride, because phenothiazines may potentitate the toxicity of 
organophosphates and the activity of procaine hydrochloride. \1\
    (5) Federal law restricts this drug to use by or on the order of a 
licensed veterinarian.\1\

[40 FR 13858, Mar. 27, 1975, as amended at 50 FR 41490, Oct. 11, 1985]



Sec.  522.2610  Trimethoprim and sulfadiazine sterile suspension.

    (a)(1) Specifications. Each milliliter of sterile aqueous suspension 
contains 240 milligrams (40 milligrams of trimethoprim and 200 
milligrams of sulfadiazine).
    (2) Sponsor. See 000061 and 000856 in Sec.  510.600(c) of this 
chapter.
    (3) Conditions of use--(i) Dosage. One milliliter (40 milligrams of 
trimethoprim and 200 milligrams of sulfadiazine) per 20 pounds (9 
kilograms) of body weight per day.
    (ii) Indications. For dogs for 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. For subcutaneous use in dogs only; administer 
once every 24 hours, or for severe infections, after an initial dose, 
administer half the normal daily dose every 12 hours; continue therapy 2 
to 3 days after clinical signs of infection have subsided; if no 
improvement is seen in 3 to 5 days, reevaluate diagnosis; injection may 
be used alone or in conjunction with oral dosing; not recommended for 
use for more than 14 days; a complete blood count should be done for 
prolonged use; Federal law restricts this drug to use by or on the order 
of a licensed veterinarian.
    (b)(1) Specifications. Each milliliter of sterile aqueous suspension 
contains 480 milligrams (80 milligrams of trimethoprim and 400 
milligrams of sulfadiazine (as the sodium salt)).
    (2) Sponsor. See 000856 and 011716 in Sec.  510.600(c) of this 
chapter.
    (3) Conditions of use--(i) Dosage. Two milliliters (160 milligrams 
of trimethoprim and 800 milligrams of sulfadiazine) per 100 pounds (45 
kilograms) of body weight per day.
    (ii) Indications. For horses where systemic anti-bacterial action 
against sensitive organisms is required during treatment of acute 
strangles, respiratory tract infections, acute urogenital infections, 
and wound infections and abscesses.
    (iii) Limitations. For intravenous use; administer as single, daily 
dose for 5 to 7 days; daily dose may also be halved and given morning 
and evening; continue acute infection therapy 2 to 3 days after clinical 
signs have subsided; if no improvement of acute infections

[[Page 289]]

is seen in 3 to 5 days, reevaluate diagnosis; a complete blood count 
should be done periodically for prolonged use; not for use in horses 
intended for food; Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[48 FR 241, Jan. 4, 1983, as amended at 48 FR 23180, May 24, 1983; 48 FR 
42809, Sept. 20, 1983; 61 FR 5507, Feb. 13, 1996; 61 FR 8873, Mar. 6, 
1996; 62 FR 61625, Nov. 19, 1997]



Sec.  522.2615  Tripelennamine hydrochloride injection.

    (a) Specifications. Each milliliter of aqueous solution contains 20 
milligrams of tripelennamine hydrochloride.
    (b) Sponsor. See Nos. 053501 and 059130 in Sec.  510.600(c) of this 
chapter.
    (c) Related tolerances. See Sec.  556.741 of this chapter.
    (d) Conditions of use--(1) Amount--(i) Dogs, cats, and horses. For 
intramuscular use only at a dose of 0.5 milligram per pound of body 
weight.
    (ii) Cattle. Administer intravenously or intramuscularly at a dose 
of 0.5 milligram per pound of body weight.
    (2) Indications for use. For use in treating 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 food purposes. 
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]



Sec.  522.2640  Tylosin injectable dosage forms.



Sec.  522.2640a  Tylosin injection.

    (a) Specifications. Each milliliter of sterile solution of 50 
percent propylene glycol with 4 percent benzyl alcohol contains 50 to 
200 milligrams of tylosin activity (as tylosin base). Tylosin conforms 
to the appropriate antibiotic standard. Tylosin contains at least 95 
percent tylosin as a combination of tylosin A, tylosin B, tylosin C, and 
tylosin D of which at least 80 percent is tylosin A as determined by a 
method entitled ``Determination of Factor Content in Tylosin by High 
Performance Liquid Chromatography,'' which is incorporated by reference. 
Copies are available from the Dockets Management Branch (HFA-305), Food 
and Drug Administration, rm. 1-23, 12420 Parklawn Dr., Rockville, MD 
20857, or available for inspection at the Office of the Federal 
Register, 800 North Capitol Street, NW., suite 700, Washington, DC 
20001.
    (b) Sponsors. (1) See No. 000986 in Sec.  510.600(c) of this chapter 
for use in paragraphs (e)(1), (2), and (3) of this section.
    (2) See No. 000010 in Sec.  510.600(c) of this chapter for use as in 
paragraphs (e)(1) and (2) of this section.
    (c) NAS/NRC status. These conditions of use are NAS/NRC reviewed and 
found effective. NADA's for these uses need not include effectiveness 
data as specified by Sec.  514.111 of this chapter but may require 
bioequivalency and safety information.
    (d) Related tolerances. See Sec.  556.740 of this chapter.
    (e) Conditions of use--(1) Beef cattle and nonlactating dairy 
cattle--(i) Amount. 8 milligrams per pound of body weight once daily.
    (ii) Indications for use. Treatment of bovine respiratory complex 
(shipping fever, pneumonia) usually associated with Pasteurella 
multocida and Corynebacterium pyogenes; foot rot (necrotic 
pododermatitis) and calf diphtheria caused by Fusobacterium necrophorum 
and metritis caused by Corynebacterium pyogenes.
    (iii) Limitations. Administer intramuscularly for not more than 5 
consecutive days. Continue treatment 24 hours after symptoms disappear. 
Do not inject more than 10 milliliters per site. Do not use in lactating 
dairy cattle. Use a 50-milligram-per-milliliter solution for calves 
weighing less than 200 pounds. Do not administer within 21 days of 
slaughter.

[[Page 290]]

    (2) Swine--(i) Amount. 4 milligrams per pound of body weight twice 
daily.
    (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. Administer intramuscularly for not more than 3 
consecutive days. Continue treatment 24 hours after symptoms disappear. 
Do not inject more than 5 milliliters per site. Do not administer within 
14 days of slaughter. If tylosin medicated drinking water is used as 
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.
    (3) Dogs and cats--(i) Amount. 3 to 5 milligrams per pound of body 
weight 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. For intramuscular use only. If there is no 
response to therapy in 5 days, diagnosis and treatment should be 
reassessed. Use a 50-milligram-per-milliliter solution only. Dogs and 
cats receiving a dose of less than 50 milligrams (1 milliliter) should 
be dosed with a tuberculin syringe. Federal law restricts this drug to 
use by or on the order of a licensed veterinarian.

[46 FR 48643, Oct. 2, 1981, as amended at 47 FR 9398, Mar. 5, 1982; 50 
FR 49841, Dec. 5, 1985; 50 FR 50292, Dec. 10, 1985; 53 FR 40728, Oct. 
18, 1988; 59 FR 14365, Mar. 28, 1994; 62 FR 35077, June 30, 1997]



Sec.  522.2662  Xylazine hydrochloride injection.

    (a) Specifications. Xylazine hydrochloride injection is a sterile 
aqueous solution containing xylazine hydrochloride equivalent to 100 
milligrams of xylazine in each milliliter of solution when intended for 
use in horses, wild deer, and elk, and 20 milligrams of xylazine per 
milliliter of solution when intended for use in dogs and cats.
    (b) Sponsor. See 000856 in Sec.  510.600(c) of this chapter for use 
in horses, wild deer, and elk. See 000859 and 061651 in Sec.  510.600(c) 
of this chapter for use in horses, wild deer, elk, dogs, and cats. See 
061690 in Sec.  510.600(c) of this chapter for use in horses, wild deer, 
elk, dogs, and cats. See 000010 in Sec.  510.600(c) of this chapter for 
use in horses only.
    (c) Conditions of use. (1) The drug is used in horses, wild deer, 
elk, dogs, and cats to produce sedation, as an analgesic, and a 
preanesthetic to local anesthesia. It may also be used in horses, dogs, 
and cats as a preanesthetic to general anesthesia.
    (2) It is administered as follows:
    (i) To horses from a solution containing 100 milligrams of xylazine 
per milliliter, intravenously at 0.5 milligram per pound of body weight, 
or intramuscularly at 1.0 milligram per pound of body weight.
    (ii) To dogs and cats from a solution containing 20 milligrams of 
xylazine per milliliter; intravenously at 0.5 milligram per pound of 
body weight or intramuscularly or subcutaneously at 1.0 milligram per 
pound of body weight. In dogs over 50 pounds, a dosage of 0.5 mg. per 
pound administered intramuscularly may provide sufficient sedation and/
or analgesia for most procedures.
    (iii) To wild deer and elk from a solution containing 100 milligrams 
of xylazine (as xylazine hydrochloride) per milliliter, intramuscularly, 
by hand syringe or syringe dart, in the heavy muscles of the croup or 
shoulder as follows:
    (a) Fallow deer, 2 to 4 milligrams per pound.
    (b) Mule deer, sika deer, and whitedeer, 1 to 2 milligrams per 
pound.
    (c) Elk, 0.25 to 0.5 milligram per pound.

[[Page 291]]

    (3) Not to be administered to food-producing animals.
    (4) 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 24884, June 21, 1976; 
41 FR 28265, July 9, 1976; 53 FR 4848, Feb. 18, 1988; 53 FR 23608, June 
23, 1988; 53 FR 40728, Oct. 18, 1988; 55 FR 18724, May 4, 1990; 55 FR 
32616, Aug. 10, 1990; 59 FR 14367, Mar. 28, 1994; 60 FR 33110, June 27, 
1995; 60 FR 35122 and 35123, July 6, 1995; 61 FR 46548, Sept. 4, 1996; 
62 FR 35077, June 30, 1997]



Sec.  522.2670  Yohimbine injectable.

    (a) Specifications. Each milliliter of sterile aqueous solution 
contains either 2 or 5 milligrams of yohimbine (as hydrochloride).
    (b) Sponsor. See 061690 in Sec.  510.600(c) of this chapter for use 
of 2 milligrams per milliliter solution in dogs.
    (1) Amount. 0.05 milligram per pound (0.11 milligram per kilogram) 
of body weight.
    (2) Indications for use. To reverse the effects of xylazine in dogs.
    (3) Limitations. For intravenous use in dogs only. Not for use in 
food-producing animals. Safety of use in pregnant dogs or in dogs 
intended for breeding has not been established. Federal law restricts 
this drug to use by or on the order of a licensed veterinarian.
    (c) Sponsor. See 053923 in Sec.  510.600(c) of this chapter for use 
of 5 milligrams per milliliter solution in deer and elk.
    (1) Amount. 0.2 to 0.3 milligram per kilogram of body weight.
    (2) Indications for use. As an antagonist to xylazine sedation in 
free ranging or confined members of the family Cervidae (deer and elk).
    (3) Limitations. For intravenous use only. 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.

[58 FR 8543, Feb. 16, 1993, as amended at 60 FR 57832, Nov. 22, 1995]



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.
    (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.
    (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.
    (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.
    (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.

[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]

[[Page 292]]



PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS--Table of Contents




Sec.
524.86 Amitraz liquid.
524.154 Bacitracin or bacitracin zinc-neomycin sulfate-polymyxin B 
          sulfate ophthalmic ointment.
524.155 Bacitracin zinc-polymyxin B sulfate-neomycin sulfate-
          hydrocortisone or hydrocortisone acetate ophthalmic ointment.
524.390 Chloramphenicol ophthalmic and topical dosage forms.
524.390a Chloramphenicol ophthalmic ointment.
524.390b Chloramphenicol ophthalmic solution.
524.390d Chloramphenicol-prednisolone ophthalmic ointment.
524.402 Chlorhexidine ointment.
524.450 Clotrimazole cream.
524.463 Copper naphthenate solution.
524.520 Cuprimyxin cream.
524.575 Cyclosporine ophthalmic ointment.
524.660 Dimethyl sulfoxide ophthalmic and topical dosage forms.
524.660a Dimethyl sulfoxide solution.
524.660b Dimethyl sulfoxide gel.
524.770 Doramectin.
524.802 Enrofloxacin, silver sulfadiazine emulsion.
524.814 Eprinomectin.
524.900 Famphur.
524.920 Fenthion.
524.960 Flumethasone, neomycin sulfate, and polymyxin B sulfate 
          ophthalmic solutions.
524.981 Fluocinolone acetonide ophthalmic and topical dosage forms.
524.981a Fluocinolone acetonide cream.
524.981b Fluocinolone acetonide solution.
524.981c Fluocinolone acetonide, neomycin sulfate cream.
524.981d Fluocinolone acetonide, dimethyl sulfoxide solution.
524.981e Fluocinolone acetonide, dimethyl sulfoxide otic solution.
524.1005 Furazolidone aerosol powder.
524.1044 Gentamicin sulfate ophthalmic and topical dosage forms.
524.1044a Gentamicin ophthalmic solution.
524.1044b Gentamicin sulfate, betamethasone valerate otic solution.
524.1044c Gentamicin ophthalmic ointment.
524.1044d Gentamicin sulfate, betamethasone valerate ointment.
524.1044e Gentamicin sulfate spray.
524.1044f Gentamicin sulfate, betamethasone valerate topical spray.
524.1044g Gentamicin sulfate, betamethasone valerate, clotrimazole 
          ointment.
524.1044h Gentamicin sulfate, mometasone furoate, clotrimazole otic 
          suspension.
524.1140 Imidacloprid and ivermectin.
524.1193 Ivermectin pour-on.
524.1195 Ivermectin otic suspension.
524.1200 Kanamycin ophthalmic and topical dosage forms.
524.1200a Kanamycin ophthalmic ointment.
524.1200b Kanamycin ophthalmic aqueous solution.
524.1204 Kanamycin sulfate, calcium amphomycin, and hydrocortisone 
          acetate.
524.1240 Levamisole.
524.1376 2-Mercaptobenzothiazole solution.
524.1443 Miconazole nitrate cream; miconazole nitrate lotion; miconazole 
          nitrate spray.
524.1446 Milbemycin oxime solution.
524.1451 Moxidectin.
524.1465 Mupirocin ointment.
524.1484 Neomycin sulfate ophthalmic and topical dosage forms.
524.1484a Neomycin sulfate ophthalmic ointment.
524.1484b Neomycin sulfate, isoflupredone acetate, tetracaine 
          hydrochloride, and myristyl-gamma-picolinium chloride, topical 
          powder.
524.1484c Neomycin sulfate, isoflupredone acetate, tetracaine 
          hydrochloride ointment.
524.1484d Neomycin sulfate, hydrocortisone acetate, tetracaine 
          hydrochloride ear ointment.
524.1484e Neomycin sulfate and polymyxin B sulfate ophthalmic solution.
524.1484f Neomycin sulfate, prednisolone acetate, tetracaine 
          hydrochloride eardrops.
524.1484g Neomycin sulfate-thiabendazole-dexamethasone solution.
524.1484h Neomycin, penicillin, polymyxin, hydrocortisone suspension.
524.1484i Neomycin sulfate, hydrocortisone acetate, sterile ointment.
524.1484j [Reserved]
524.1484k Neomycin sulfate, prednisolone, tetracaine, and squalane 
          topical-otic suspension.
524.1580 Nitrofurazone ophthalmic and topical dosage forms.
524.1580a [Reserved]
524.1580b Nitrofurazone ointment.
524.1580c Nitrofurazone soluble powder.
524.1580d [Reserved]
524.1580e Nitrofurazone ointment with butacaine sulfate.
524.1600 Nystatin ophthalmic and topical dosage forms.
524.1600a Nystatin, neomycin, thiostrepton, and triamcinolone acetonide 
          ointment.
524.1600b Nystatin, neomycin, thiostrepton, and triamcinolone acetonide 
          ophthalmic ointment.
524.1662 Oxytetracycline hydrochloride ophthalmic and topical dosage 
          forms.
524.1662a Oxytetracycline hydrochloride and hydrocortisone spray.

[[Page 293]]

524.1662b Oxytetracycline hydrochloride, polymyxin B sulfate ophthalmic 
          ointment.
524.1742 N-(Mercaptomethyl) phthalimide S-(O,O-dimethyl 
          phosphorodithioate) emulsifiable liquid.
524.1880 Prednisolone-neomycin sulfate ophthalmic ointment.
524.1881 Prednisolone acetate ophthalmic and topical dosage forms.
524.1881a [Reserved]
524.1881b Prednisolone acetate-neomycin sulfate sterile suspension.
524.1883 Prednisolone sodium phosphate-neomycin sulfate ophthalmic 
          ointment.
524.1982 Proparacaine hydrochloride ophthalmic solution.
524.2098 Selamectin.
524.2101 Selenium disulfide suspension.
524.2350 Tolnaftate cream.
524.2481 Triamcinolone acetonide cream.
524.2482 Triamcinolone spray.
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 liquid.

    (a) Specifications. Amitraz liquid contains 19.9 percent amitraz in 
an organic solvent.
    (b) Sponsor. See No. 000009 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.
    (3) Limitations. Continue treatment until no viable mites are found 
in skin scrapings at 2 successive treatments, or until 6 treatments have 
been applied. Do not use for treatment of localized demodicosis or 
scabies. Federal law restricts this drug to use by or on the order of a 
licensed veterinarian.

[47 FR 18589, Apr. 30, 1982]



Sec.  524.154  Bacitracin or bacitracin zinc-neomycin sulfate-polymyxin B sulfate ophthalmic ointment.

    (a) Sponsor. To firms identified in Sec.  510.600(c) of this chapter 
as follows:
    (1) To 000009; each gram contains 500 units of bacitracin, 3.5 
milligrams of neomycin, and 10,000 units of polymyxin B.
    (2) To 000061 and 025463; each gram contains 400 units of bacitracin 
zinc, 3.5 milligrams of neomycin, and 10,000 units of polymyxin B 
sulfate.
    (b) Conditions of use. 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. Laboratory tests should be conducted including in 
vitro culturing and susceptibility tests on samples collected prior to 
treatment. 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]



Sec.  524.155  Bacitracin zinc-polymyxin B sulfate-neomycin sulfate-hydrocortisone or hydrocortisone acetate ophthalmic ointment.

    (a) Sponsor. To firms identified in Sec.  510.600(c) of this chapter 
as follows:
    (1) To 000061; each gram of ointment contains 400 units of 
bacitracin zinc, 10,000 units of polymyxin B sulfate, 5 milligrams of 
neomycin sulfate (equivalent to 3.5 milligrams of neomycin base), and 10 
milligrams of hydrocortisone.
    (2) To 025463; each gram of ointment contains 400 units of 
bacitracin zinc, 10,000 units of polymyxin B sulfate, 5 milligrams of 
neomycin sulfate (equivalent to 3.5 milligrams of neomycin base), and 10 
milligrams of hydrocortisone acetate.
    (b) Conditions of use. 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. All topical ophthalmic preparations containing 
corticosteroids with or without an antimicrobial agent are 
contraindicated in the initial treatment of corneal ulcers. They should 
not be used until the infection is under control and corneal 
regeneration is well underway. Federal law restricts

[[Page 294]]

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]



Sec.  524.390  Chloramphenicol ophthalmic and topical dosage forms.



Sec.  524.390a  Chloramphenicol ophthalmic ointment.

    (a) Specifications. Each gram contains 10 milligrams chloramphenicol 
in a petrolatum base.
    (b) Sponsor. See Nos. 000856 and 025463 in Sec.  510.600(c) of this 
chapter for use as in paragraph (c)(1)(i) of this section. See No. 
017030 for use as in paragraph (c)(1)(ii) of this section.
    (c) Conditions of use. Dogs and cats. (1) Amount. Apply as follows:
    (i) Every 3 hours around the clock for 48 hours after which night 
instillations may be omitted.
    (ii) Four to six times daily to affected eye for the first 72 hours 
depending upon the severity of the condition. A small amount of ointment 
should be placed in the lower conjunctival sac.
    (2) Indications for use. Treatment of bacterial conjunctivitis 
caused by pathogens susceptible to chloramphenicol.
    (3) Limitations. Continue treatment for 48 hours (2 days) after eye 
appears normal. Therapy for cats should not exceed 7 days. Prolonged use 
in cats may produce blood dyscrasias. If improvement is not noted in a 
few days a change of therapy should be considered. When infection may be 
cause of disease, especially in purulent or catarrhal conjunctivitis, 
attempts should be made to determine through susceptibility testing, 
which antibiotics will be effective prior to applying ophthalmic 
preparations. This chloramphenicol product must not be used in animals 
producing meat, eggs, or milk. 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 37333, Aug. 18, 1992]



Sec.  524.390b  Chloramphenicol ophthalmic solution.

    (a) Specifications. Each milliliter contains 5 milligrams of 
chloramphenicol.
    (b) Sponsor. See No. 017030 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use. Dogs and Cats. (1) Amount. Apply one or two 
drops, 4 to 6 times a day for the first 72 hours, depending upon the 
severity of the condition. Intervals between applications may be 
increased after the first 2 days.
    (2) Indications for use. Treatment of bacterial conjunctivitis 
caused by organisms susceptible to chloramphenicol. Therapy should be 
continued for 48 hours after the eye appears normal.
    (3) Limitations. Therapy for cats should not exceed 7 days. As with 
other antibiotics, prolonged use may result in overgrowth of 
nonsusceptible organisms. If superinfection occurs, or if clinical 
improvement is not noted within a reasonable period, discontinue use, 
and institute appropriate therapy. Prolonged use in cats may produce 
blood dyscrasias. Chloramphenicol products 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 37333, Aug. 18, 1992]



Sec.  524.390d  Chloramphenicol-prednisolone ophthalmic ointment.

    (a) Specifications. Each gram contains 10 milligrams of 
chloramphenicol and 2.5 milligrams of prednisolone acetate.
    (b) Sponsor. See No. 017030 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use. Dogs and cats. (1) Amount. Apply 4 to 6 times 
daily to the affected eye for the first 72 hours depending upon the 
severity of the condition. Continue treatment for 48 hours after the eye 
appears normal.
    (2) Indications for use. Treatment of bacterial conjunctivitis and 
ocular inflammation caused by organisms susceptible to chloramphenicol.
    (3) Limitations. Therapy for cats should not exceed 7 days, 
prolonged use in cats may produce blood dyscrasia. As with other 
antibiotics, prolonged

[[Page 295]]

use may result in overgrowth of nonsusceptible organisms. If 
superinfection occurs or if clinical improvement is not noted within a 
reasonable period, discontinue use and institute appropriate therapy. 
All topical ophthalmic preparations containing corticosteroids, with or 
without an antimicrobial agent, are contraindicated in the initial 
treatment of corneal ulcers. They should not be used until the infection 
is under control and corneal regeneration is well underway. 
Chloramphenicol products 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 37334, Aug. 18, 1992]



Sec.  524.402  Chlorhexidine ointment.

    (a) Specifications. The product contains 1-percent chlorhexidine 
acetate in an ointment base.
    (b) Sponsor. See Nos. 000856 and 058829 in Sec.  510.600(c) of this 
chapter.
    (c) Conditions of use--(1) Indications for use. Use as a topical 
antiseptic ointment for surface wounds on dogs, cats, and horses.
    (2) Limitations. Not for use in horses intended for food.

[67 FR 8860, Feb. 27, 2002]



Sec.  524.450  Clotrimazole cream.

    (a) Specifications. Each gram of cream contains 10 milligrams of 
clotrimazole.
    (b) Sponsor. See 000859 in Sec.  510.600(c).
    (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.
    (3) Limitations. Wash hands thoroughly after use to avoid spread of 
infection. Federal law restricts this drug to use by or on the order of 
a licensed veterinarian.

[40 FR 48128, July 18, 1980]



Sec.  524.463  Copper naphthenate solution.

    (a) Specifications. The drug contains 37.5 percent copper 
naphthenate in a suitable solvent.
    (b) Sponsor. See Nos. 000856 and 017135 in Sec.  510.600(c) of this 
chapter.
    (c) Conditions of use--Horses and ponies--(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. Remove debris and 
necrotic material before applying. Avoid contact around eyes. Do not use 
on animals that are raised for food production. Do not contaminate feed. 
Do not allow runoff of excess drug into hair because contact with the 
drug may cause some hair loss.

[47 FR 4250, Jan. 29, 1982]



Sec.  524.520  Cuprimyxin cream.

    (a) Specifications. The drug contains 0.5 percent cuprimyxin (6-
methoxy-1-phenazinol 5, 10-dioxide, cupric complex) in an aqueous cream 
base.
    (b) Sponsor. See No. 063238 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use. (1) Cuprimyxin is a broad spectrum 
antibacterial and antifungal cream for the topical treatment of 
superficial infections in horses, dogs, and cats caused by bacteria, 
dermatophytes (Trichophyton spp., Microsporum spp.) and yeast (Candida 
albicans) affecting skin, hair, and external mucosae.
    (2) The cream is applied twice daily to affected areas by rubbing 
into lesions. Treatment should be continued for a few days after 
clinical recovery to avoid possible relapses.
    (3) After application to cutaneous areas, a change in color from 
dark green to pink is due to the liberation of free myxin from its 
copper complex.
    (4) If no response is seen within seven days, diagnosis and therapy 
should be reevaluated. If any adverse local reaction is observed after 
topical application, discontinue treatment.

[[Page 296]]

    (5) 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 45 FR 56799, Aug. 26, 1980; 
66 FR 46706, Sept. 7, 2001]



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 to 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. Place ointment directly on cornea or into the 
conjunctival sac. Safety of use in puppies, pregnant or breeding animals 
has not been determined. 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]



Sec.  524.660  Dimethyl sulfoxide ophthalmic and topical dosage forms.



Sec.  524.660a  Dimethyl sulfoxide solution.

    (a) Specifications. Dimethyl sulfoxide contains 90 percent of 
dimethyl sulfoxide and 10 percent of water.
    (b) Sponsor. See No. 000856 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use. (1) It is used or intended for use as a 
topical application to reduce acute swelling due to trauma:
    (i) In horses administered 2 or 3 times daily in an amount not to 
exceed 100 milliliters per day. Total duration of therapy should not 
exceed 30 days.
    (ii) In dogs administered 3 or 4 times daily in an amount not to 
exceed 20 milliliters per day. Total duration of therapy should not 
exceed 14 days.
    (2) Not for use in horses and dogs intended for breeding purposes 
nor in horses slaughtered for food. Other topical medications should 
only be used when the dimethyl sulfoxide treated area is thoroughly dry. 
Do not administer by any other route.
    (3) For 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]



Sec.  524.660b  Dimethyl sulfoxide gel.

    (a) Specifications. Dimethyl sulfoxide gel, veterinary contains 90 
percent dimethyl sulfoxide in an aqueous gel.
    (b) Sponsor. See No. 000856 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use--(1) Indications for use. For use on horses 
and dogs as a topical application to reduce acute swelling due to 
trauma.
    (2) Amount--(i) Horses. Administer 2 or 3 times daily in an amount 
not to exceed 100 grams per day. Total duration of therapy should not 
exceed 30 days.
    (ii) Dogs. Administer 3 or 4 times daily in an amount not to exceed 
20 grams per day. Total duration of therapy should not exceed 14 days.
    (3) Limitations. Do not use in horses and dogs intended for breeding 
purposes or in horses slaughtered for food. Restricted to topical use on 
horses and dogs only. Due to rapid penetrating ability of dimethyl 
sulfoxide, rubber gloves should be worn when applying the drug. No other 
medications should be present on the skin prior to application of the 
drug. 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 48 FR 56205, Dec. 20, 1983; 
61 FR 5507, Feb. 13, 1996]



Sec.  524.770  Doramectin.

    (a) Specifications. Each milliliter of solution contains 5 
milligrams of doramectin.
    (b) Sponsor. See 000069 in Sec.  510.600(c) of this chapter.
    (c) Related tolerances. See Sec.  556.225 of this chapter.
    (d) Conditions of use--Cattle--(1) Amount. 5 milligrams per 10 
kilograms (5 milligrams per 22 pounds).
    (2) Indications for use. For treatment and control of 
gastrointestinal roundworms, lungworms, eyeworms, grubs, biting and 
sucking lice, horn flies, and mange mites. To control infections and to 
protect from reinfection with Cooperia oncophora and Dictyocaulus 
viviparus for 21 days,

[[Page 297]]

Ostertagia ostertagi, C. punctata, and Oesophagostomum radiatum for 28 
days, and Haemonchus placei for 35 days after treatment.
    (3) Limitations. Administer as a single dose. Do not slaughter 
cattle within 45 days of latest treatment. Not for use in female dairy 
cattle 20 months of age or older. Do not use in calves to be processed 
for veal. Consult your veterinarian for assistance in the diagnosis, 
treatment, and control of parasitism.

[62 FR 65753, Dec. 16, 1997, as amended at 63 FR 68183, Dec. 10, 1998; 
64 FR 49082, Sept. 10, 1999]



Sec.  524.802  Enrofloxacin, silver sulfadiazine emulsion.

    (a) Specifications. Each milliliter contains 5 milligrams (mg) 
enrofloxacin and 10 mg silver sulfadiazine.
    (b) Sponsor. See No. 000859 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 extra-label 
use of this drug in food-producing animals.

[65 FR 66620, Nov. 7, 2000]



Sec.  524.814  Eprinomectin.

    (a) Specifications. Each milliliter contains 5 milligrams of 
eprinomectin.
    (b) Sponsor. See No. 000006 in Sec.  510.600(c) of this chapter.
    (c) Related tolerances. See Sec.  556.227 of this chapter.
    (d) Conditions of use--(1) Amount. One milliliter (5 milligrams) per 
10 kilograms of body weight (500 micrograms per kilogram).
    (2) Indications for use. The drug is used in beef and dairy cattle 
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. vivaparus for 21 
days after treatment and H. irritans for 7 days after treatment.
    (3) Limitations. Apply topically along backbone from withers to 
tailhead. Consult your veterinarian for assistance in the diagnosis, 
treatment, and control of parasitism.

[62 FR 33997, June 24, 1997, as amended at 63 FR 59715, Nov. 5, 1998]



Sec.  524.900  Famphur.

    (a) Chemical name. O,O- Dimethyl O-[p-(dimethylsulfamoyl)phenyl] 
phosphorothioate.
    (b) Specifications. The drug is in liquid form containing 13.2 
percent famphur.
    (c) Sponsor. See Nos. 000061 and 060594 in Sec.  510.600(c) of this 
chapter.
    (d) 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.
    (e) Related tolerances. See Sec.  556.273 of this chapter.
    (f) Conditions of use. (1) The drug is used as a pour-on formulation 
for the control of cattle grubs and to reduce cattle lice infestations.
    (2) It is used at the rate of 1 ounce per 200 pounds body weight, 
not to exceed a total dosage of 4 ounces, applied from the shoulder to 
the tail head as a single treatment. It is applied as soon as possible 
after heel fly activity ceases. 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, over-excitement 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

[[Page 298]]

and Brahman crossbreeds are less tolerant of cholinesterase-inhibiting 
insecticides than other breeds. Do not treat Brahman bulls.
    (3) Do not slaughter within 35 days after treatment. Swine should be 
eliminated from area where run-off 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]



Sec.  524.920  Fenthion.

    (a) Chemical name. O,O-Dimethyl O-[4-(methylthio)-m- tolyl] 
phosphorothioate.
    (b) Specifications. (1) The drug is in a liquid form containing 3 
percent of fenthion.
    (2) Sponsor. See No. 000859 in Sec.  510.600(c) of this chapter.
    (3) 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.
    (4) Related tolerances. See 40 CFR 180.214.
    (5) Conditions of use. (i) The drug is used as a pour-on formulation 
for the control of grubs and lice in beef and nonlactating cattle.
    (ii) It is used at the rate of one-half fluid ounce per 100 pounds 
of body weight placed 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. 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.
    (c) Specifications. (1) The drug is in a liquid form containing 20 
percent fenthion.
    (2) Sponsor. See No. 000859 in Sec.  510.600(c) of this chapter.
    (3) 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.
    (4) Related tolerances. See 40 CFR 180.214.
    (5) Conditions of use. (i) The drug is used for control of cattle 
grubs and as an aid in controlling lice on beef cattle and on dairy 
cattle not of breeding age.
    (ii) It is applied as a single application placed on the backline of 
animals as follows:

------------------------------------------------------------------------
                                                               Dosage
                     Weight of animal                      (milliliters)
------------------------------------------------------------------------
150 to 300 lb............................................             4
301 to 600 lb............................................             8
601 to 900 lb............................................            12
901 to 1,200 lb..........................................            16
Over 1,200 lb............................................            20
------------------------------------------------------------------------


For most effective results, cattle should be treated as soon as possible 
after heel-fly activity ceases. 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 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. A second 
application is required for animals heavily infested with lice or for 
those which become reinfested. A second application should

[[Page 299]]

be made no sooner than 35 days after the first treatment.
    (iii) Do not treat dairy cattle of breeding age; calves less than 3 
months old; sick, convalescent, or severely stressed livestock.
    (iv) Do not treat cattle for 10 days before or after shipping, 
weaning, dehorning, or after exposure to contagious or infectious 
diseases.
    (v) Do not slaughter within 45 days of treatment.
    (d) Specifications. (1) 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.
    (2) Sponsor. See No. 000859 in Sec.  510.600(c) of this chapter.
    (3) Special considerations. Fenthion is a cholinesterase inhibitor. 
Do not use this product on dogs simultaneously with or within 14 days 
before or after treatment with or exposure to cholinesterase-inhibiting 
drugs, pesticides, or chemicals. Do not use with flea or tick collars.
    (4) Conditions of use--(i) Amount. Four to 8 milligrams per kilogram 
of body weight.
    (ii) Indications for use. For flea control on dogs only.
    (iii) Limitations. Apply the contents of the proper size, single-
dose tube directly to one spot on the dog's skin. Frequency of repeat 
treatments depends upon rate of flea reinfestations. Do not use more 
often than once every 2 weeks. Treatment at 2-week intervals is not to 
exceed 6 months. Do not use on puppies under 10 weeks of age. Do not use 
on sick, stressed, or convalescing dogs. Safe use in breeding males has 
not been established. 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 41 FR 16656, Apr. 21, 1976; 
42 FR 58741, Nov. 11, 1977; 45 FR 62425, Sept. 19, 1980; 50 FR 19169, 
May 7, 1985]



Sec.  524.960  Flumethasone, neomycin sulfate, and polymyxin B sulfate ophthalmic solutions.

    (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. 000856 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. (i) In treating ophthalmological conditions 
associated with bacterial infections, the drug is contraindicated in 
those cases in which microorganisms are not susceptible to the 
antibiotics incorporated in the drug.
    (ii) The drug is contraindicated in infectious tuberculous lesions 
of the eye, early acute stages of viral diseases of the cornea and 
conjunctiva, herpes simplex lesions of the eye, and fungal infections of 
the conjunctiva and eyelids.
    (iii) The usual precautions and contraindications for 
corticosteroids and adrenocorticoids are applicable with this drug. 
Corticosteroids may inhibit essential inflammatory responses intrinsic 
to the fundamental healing mechanism. Adrenocorticoid compounds have 
been reported to cause an increase in intraocular pressure. Intraocular 
pressure should be checked frequently. Ocular reexaminations should be 
made at frequent intervals during long-term therapy.
    (iv) 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]

[[Page 300]]



Sec.  524.981  Fluocinolone acetonide ophthalmic and topical dosage forms.



Sec.  524.981a  Fluocinolone acetonide 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. (1) The drug is indicated for the relief of 
pruritus and inflammation associated with certain superficial acute and 
chronic dermatoses in dogs. It is used in the treatment of allergic and 
acute moist dermatitis and for the relief of superficial inflammation 
caused by chemical and physical abrasions and burns.
    (2) A small amount is applied to the affected area two or three 
times daily.
    (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]



Sec.  524.981b  Fluocinolone acetonide solution.

    (a) Specifications. The drug contains 0.01 percent fluocinolone 
acetonide in propylene glycol with citric acid.
    (b) Sponsor. See No. 099207 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use. (1) The drug is indicated for the relief of 
pruritus and inflammation associated with otitis externa and certain 
superficial acute and chronic dermatoses in the dog. It is also 
indicated for the relief of pruritus and inflammation associated with 
acute otitis externa and certain superficial acute and chronic 
dermatoses in the cat.
    (2) A small amount of solution is applied to the affected area 2 or 
3 times daily.
    (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]



Sec.  524.981c  Fluocinolone acetonide, neomycin sulfate 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. (1) The drug is used in the relief of 
pruritus and inflammation associated with superficial acute and chronic 
dermatoses in dogs. It is used in the treatment of such conditions as 
allergic and acute moist dermatoses and nonspecific dermatoses in dogs. 
It is used in the treatment of wound infections in dogs and cats.
    (2) A small amount is applied to the infected area two or three 
times daily.
    (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]



Sec.  524.981d  Fluocinolone acetonide, dimethyl sulfoxide solution.

    (a) Specifications. Each milliliter of solution contains 0.01 
percent fluocinolone acetonide and 20 percent dimethyl sulfoxide with 
propylene glycol and citric acid.
    (b) Sponsor. See No. 000856 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use. (1) The drug is used in dogs 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.
    (2) It is administered by instillation of 1 to 2 milliliters into 
each anal sac following expression of anal sac contents. It may be 
necessary to repeat treatment at 60-day intervals to maintain an odor-
free state. The total dosage used should not exceed 2 milliliters per 
anal sac per treatment.
    (3) For use only by or on the order of a licensed veterinarian.

[40 FR 13873, Mar. 27, 1975, as amended at 61 FR 5507, Feb. 13, 1996]



Sec.  524.981e  Fluocinolone acetonide, dimethyl sulfoxide otic solution.

    (a) Specifications. Each milliliter of solution contains 0.01 
percent of fluocinolone acetonide in 60 percent dimethyl sulfoxide with 
propylene glycol and citric acid.
    (b) Sponsor. See No. 000033 in Sec.  510.600(c) of this chapter.

[[Page 301]]

    (c) Conditions of use. (1) The drug is used in dogs for the relief 
of pruritis and inflammation associated with acute and chronic otitis.
    (2) It is administered at 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. The ear canal should be cleansed 
by some appropriate method prior to instillation of the solution and the 
ear should be massaged gently following instillation.
    (3) There should be careful initial evaluation and followup of 
infected ears. Incomplete response or exacerbation of corticosteroid-
responsive lesions may be due to the presence of an infection which 
requires identification or antibiotic sensitivity testing, and the use 
of the appropriate antimicrobial agent. As with any corticosteroid, 
animals with a generalized infection should not be treated with this 
product without proper supportive antimicrobial therapy. Preparations 
with dimethyl sulfoxide should not be used in pregnant animals. For use 
by or on the order of a licensed veterinarian.



Sec.  524.1005  Furazolidone aerosol powder.

    (a) Specifications. The product contains either 4 or 10 percent 
furazolidone in inert dispersing agent and propellant.
    (b) Sponsors. (1) See No. 053501 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. Not for use in horses intended for food.

[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]



Sec.  524.1044  Gentamicin sulfate ophthalmic and topical dosage forms.



Sec.  524.1044a  Gentamicin ophthalmic solution.

    (a) Specifications. Each milliliter of sterile aqueous solution 
contains gentamicin sulfate equivalent to 3 milligrams of gentamicin.
    (b) Sponsor. See No. 000061 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use. (1) The drug is used in dogs and cats for the 
topical treatment of infections of the conjunctiva caused by susceptible 
bacteria.
    (2) Administer 1 or 2 drops into the conjunctival sac 2 to 4 times a 
day.
    (3) Federal law restricts this drug to use by or on the order of a 
licensed veterinarian.

[41 FR 14189, Apr. 2, 1976, as amended at 52 FR 7832, Mar. 13, 1987]



Sec.  524.1044b  Gentamicin sulfate, betamethasone valerate otic solution.

    (a) Specifications. Each cubic centimeter of solution contains 
gentamicin sulfate equivalent to 3 milligrams of gentamicin base and 
betamethasone

[[Page 302]]

valerate equivalent to 1 milligram of betamethasone alcohol.
    (b) Sponsor. See Nos. 000061 and 051259 in Sec.  510.600(c) of this 
chapter.
    (c) Conditions of use. (1) The drug is used or indicated for use in 
dogs in the treatment of acute and chronic otitis externa caused by 
bacteria sensitive to gentamicin; the drug is also used or indicated for 
use in dogs and cats in the treatment of superficial infected lesions 
caused by bacteria sensitive to gentamicin.
    (2)(i) For the treatment of acute and chronic canine otitis externa 
caused by bacteria sensitive to gentamicin, the drug is administered by 
instillation of 3 to 8 drops of solution into the ear canal twice daily 
for 7 to 14 days. Duration of treatment will depend upon the severity of 
the condition and the response obtained. The duration of treatment and/
or frequency of the dosage may be reduced but care should be taken not 
to discontinue therapy prematurely. The external ear and ear canal 
should be properly cleaned and dried before treatment. Remove foreign 
material, debris, crusted exudates, etc., with suitable nonirritating 
solutions. Excessive hair should be clipped from the treatment area of 
the external ear.
    (ii) For the treatment of canine and feline superficial infected 
lesions caused by bacteria sensitive to gentamicin, the lesion and 
adjacent area should be properly cleaned before treatment. Excessive 
hair should be removed. A sufficient amount of the drug should be 
applied to cover the treatment area. The drug should be administered 
twice daily for 7 to 14 days.
    (3) If hypersensitivity to any of the components occurs treatment 
with this product should be discontinued and appropriate therapy 
instituted. Concomitant use with other drugs known to induce ototoxicity 
is not recommended. This preparation should not be used in conditions 
where corticosteroids are contraindicated. Do not administer parenteral 
corticosteroids during treatment with this drug. The antibiotic 
sensitivity of the pathogenic organism should be determined prior to use 
of this preparation.
    (4) For use by or on the order of a licensed veterinarian.

[40 FR 13873, Mar. 27, 1975. Redesignated at 41 FR 14189, Apr. 2, 1976, 
and amended at 52 FR 7832, Mar. 13, 1987; 61 FR 48624, Sept. 16, 1996]



Sec.  524.1044c  Gentamicin ophthalmic ointment.

    (a) Specifications. Each gram of sterile ointment contains 
gentamicin sulfate equivalent to 3 milligrams of gentamicin.
    (b) Sponsor. See No. 000061 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use. (1) The drug is used on dogs and cats for 
topical treatment of conjunctivitis caused by susceptible bacteria.
    (2) Apply approximately a \1/2\-inch strip to the affected eye 2 to 
4 times a day.
    (3) Federal law restricts this drug to use by or on the order of a 
licensed veterinarian.

[41 FR 14188, Apr. 2, 1976, as amended at 52 FR 7832, Mar. 13, 1987]



Sec.  524.1044d  Gentamicin sulfate, betamethasone valerate 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. (1) The drug is used or indicated for use in 
dogs in the treatment of acute and chronic canine otitis externa and 
canine infected superficial lesions caused by bacteria sensitive to 
gentamicin.
    (2)(i) For the treatment of acute and chronic canine otitis externa 
the drug is administered by instillation of 3 to 8 drops into the ear 
canal twice daily for 7 days. The external ear and ear canal should be 
properly cleaned and dried before treatment. Remove foreign material, 
debris, crusted exudates, etc., with suitable nonirritating solutions. 
Excessive hair should be clipped from the treatment area of the external 
ear.
    (ii) For the treatment of canine infected superficial lesions, the 
lesion and adjacent area should be properly cleaned before treatment. 
Excessive hair should be removed. A sufficient

[[Page 303]]

amount of the drug should be applied to cover the treatment area. The 
drug should be administered twice daily for 7 to 14 days.
    (3) If hypersensitivity to any of the components occurs, treatment 
should be discontinued and appropriate therapy instituted. Concomitant 
use of drugs known to induce ototoxicity should be avoided. Observe 
patients for signs of adrenocorticoid overdosage. The antibiotic 
susceptibility of the pathogenic organism should be determined prior to 
use of this preparation. Administration of recommended doses beyond 7 
days may result in delayed wound healing. Animals treated longer than 7 
days should be monitored closely.
    (4) For 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]



Sec.  524.1044e  Gentamicin sulfate 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) Conditions of use. (1) The drug is indicated for the treatment 
of pink eye in cattle (infectious bovine keratoconjunctivitis) caused by 
Moraxella bovis.
    (2) One actuation of the sprayer delivers 0.7 milliliter containing 
0.75 milligram gentamicin. The sprayer should be held upright 3 to 6 
inches from the affected eye, with the opening directed towards the eye, 
and pumped once. It is advisable to treat once a day for up to 3 days.
    (3) 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 veterinarian.

[48 FR 41157, Sept. 14, 1983, as amended 52 FR 7833, Mar. 13, 1987]



Sec.  524.1044f  Gentamicin sulfate, betamethasone valerate topical spray.

    (a) Specifications. Each milliliter of spray contains gentamicin 
sulfate equivalent to 0.57 milligram of gentamicin base and 
betamethasone valerate equivalent to 0.284 milligram of betamethasone.
    (b) Sponsor. See Nos. 000061 and 051259 in Sec.  510.600(c) of this 
chapter.
    (c) Conditions of use. (1) The drug is used in dogs in the treatment 
of infected superficial lesions caused by bacteria sensitive to 
gentamicin.
    (2) For the treatment of infected superficial lesions, the lesion 
and adjacent area should be properly cleaned before treatment. Excessive 
hair should be removed. Hold bottle upright 3 to 6 inches from the 
lesion and depress the sprayer head twice. One actuation of the sprayer 
delivers 0.7 milliliter of the spray. The drug should be administered 
with two spray actuations 2 to 4 times daily for 7 days.
    (3) If hypersensitivity to any of the components occurs, treatment 
should be discontinued and appropriate therapy instituted. The 
antibiotic susceptibility of the pathogenic organism should be 
determined prior to use of this preparation. Administration of 
recommended doses beyond 7 days may result in delayed wound healing. 
Animals treated longer than 7 days should be monitored closely.
    (4) Federal law restricts this drug to use by or on the order of a 
licensed veterinarian.

[50 FR 740, Jan. 7, 1985, as amended at 52 FR 7833, Mar. 13, 1987; 62 FR 
10220, Mar. 6, 1997]



Sec.  524.1044g  Gentamicin sulfate, betamethasone valerate, 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) Sponsor. See 000061 and 051259 in Sec.  510.600(c) of this 
chapter.
    (c) Conditions of use. (1) The drug is used for the treatment of 
canine otitis externa associated with yeast (Malassezia pachydermatis, 
formerly Pityrosporum canis) and/or bacteria susceptible to gentamicin.
    (2) For 7.5 or 15 g tube, instill 4 drops of ointment twice daily 
into the ear canal of dogs weighing less than 30

[[Page 304]]

pounds, instill 8 drops twice daily for dogs weighing 30 pounds or more. 
For 215 g bottle, instill 2 drops of ointment twice daily into the ear 
canal of dogs weighing less than 30 pounds, instill 4 drops twice daily 
for dogs weighing 30 pounds or more. Therapy should continue for 7 
consecutive days.
    (3) The external ear should be cleaned and dried before treatment. 
Remove foreign material, debris, crusted exudates, etc., with suitable 
solutions. Excessive hair should be clipped from the treatment area. If 
hypersensitivity occurs, treatment should be discontinued and alternate 
therapy instituted.
    (4) Corticosteroids administered to dogs, rabbits, and rodents 
during pregnancy have resulted in cleft palate in offspring. Other 
congenital anomalies including deformed forelegs, phocomelia, and 
anasarca have been reported in offspring of dogs which received 
corticosteroids during pregnancy. Clinical and experimental data have 
demonstrated that corticosteroids administered orally or parenterally 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.
    (5) 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]



Sec.  524.1044h  Gentamicin sulfate, mometasone furoate, clotrimazole otic suspension.

    (a) Specifications. Each gram contains gentamicin sulfate, United 
States Pharmacopeia (USP) equivalent to 3 milligram (mg) gentamicin 
base, mometasone furoate monohydrate equivalent to 1 mg mometasone, and 
10 mg clotrimazole, USP.
    (b) Sponsor. See No. 000061 in Sec.  510.6(c) of this chapter.
    (c) Conditions of use--Dogs--(1) Amount. For dogs weighing less than 
30 pounds (lb), instill 4 drops from the 5- and 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 5- and 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).

[66 FR 712, Jan. 4, 2001, as amended at 68 FR 15370, Mar. 31, 2003]



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 
([mu]g) ivermectin.
    (b) Sponsor. See No. 000859 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 [mu]g/lb (80 [mu]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]



Sec.  524.1193  Ivermectin pour-on.

    (a) Specifications. Each milliliter (mL) of solution contains 5 
milligrams of ivermectin.
    (b) Sponsors. See Nos. 050604, 051259, 051311, 058829, 059130, and 
066916 in Sec.  510.600(c) of this chapter for use as in paragraph (e) 
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) Amount. One mL per 22 pounds of body 
weight.
    (2) Indications for use in cattle. It is used topically for the 
treatment and control of: Gastrointestinal roundworms (adults and 
fourth-stage

[[Page 305]]

larvae) Ostertagia ostertagi (including inhibited stage), Haemonchus 
placei, Trichostrongylus axei, T. colubriformis, Cooperia spp., 
Oesophagostomum radiatum; (adults) O. venulosum, Strongyloides 
papillosus, Trichuris spp.; lungworms (adults and fourth-stage larvae) 
Dictyocaulus viviparus; cattle grubs (parasitic stages) Hypoderma bovis, 
H. lineatum; mites Chorioptes bovis, Sarcoptes scabei var. bovis; lice 
Linognathus vituli, Haematopinus eurysternus, Damalinia bovis, 
Solenoptes capillatus; horn flies Haematobia irritans. It is also used 
to control infections of gastrointestinal roundworms O. ostertagi, O. 
radiatum, H. placei, T. axei, Cooperia punctata, and C. oncophora for 14 
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.

[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]



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. 065274 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]



Sec.  524.1200  Kanamycin ophthalmic and topical dosage forms.



Sec.  524.1200a  Kanamycin ophthalmic ointment.

    (a) Specifications. The drug, which is in a suitable and harmless 
ointment base, contains 3.5 milligrams of kanamycin activity (as the 
sulfate) per gram of ointment.
    (b) Sponsor. See No. 000856 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use. It is indicated for use in dogs in various 
eye infections due to kanamycin sensitive bacteria. It is used treating 
conditions such as conjunctivitis, blepharitis, dacryocystitis, 
keratitis, and corneal ulcerations and as a prophylactic in traumatic 
conditions, removal of foreign bodies, and intraocular surgery. 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. For use only by or on the 
order of a licensed veterinarian.

[40 FR 13858, Mar. 27, 1975, as amended at 53 FR 27851, July 25, 1988; 
64 FR 404, Jan. 5, 1999]



Sec.  524.1200b  Kanamycin ophthalmic aqueous solution.

    (a) Specifications. The drug, which is in an aqueous solution 
including suitable and harmless preservatives and buffer substances, 
contains 10 milligrams of kanamycin activity (as the sulfate) per 
milliliter of solution.
    (b) Sponsor. See No. 000856 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use. It is indicated for use in dogs in various 
eye infections due to kanamycin sensitive bacteria. It is used in 
treating conditions such as conjunctivities, blepharitis, 
dacryocystitis, keratitis, and corneal ulcerations and as a prophylactic 
in traumatic conditions, removal of foreign bodies, and intraocular 
surgery. 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

[[Page 306]]

hours, after which the frequency of applications may be decreased. 
Treatment should be continued for at least 48 hours after the eye 
appears normal. For use only by or on the order of a licensed 
veterinarian.

[40 FR 13858, Mar. 27, 1975, as amended at 53 FR 27851, July 25, 1988; 
64 FR 404, Jan. 5, 1999]



Sec.  524.1204  Kanamycin sulfate, calcium amphomycin, and hydrocortisone acetate.

    (a) Specifications. (1) Calcium amphomycin is the calcium salt of 
amphomycin. It conforms to the following specifications:
    (i) Its potency is not less than 863 micrograms of amphomycin per 
milligram;
    (ii) Its moisture content is not more than 10 percent; and
    (iii) Its pH in a 2-percent aqueous suspension is 6.0 to 7.5.
    (2) The drug is in a water-miscible ointment or cream base and each 
gram of ointment or cream contains: 5.0 milligrams of kanamycin activity 
as the sulfate, 5.0 milligrams of amphomycin activity as the calcium 
salt, and 10.0 milligrams of hydrocortisone acetate.
    (b) Sponsor. See No. 000856 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use. (1) It is indicated for use in dogs in the 
following conditions associated with bacterial infections caused by 
organisms susceptible to one or both antibiotics: Acute otitis externa, 
furunculosis, folliculitis, pruritus, anal gland infections, erythema, 
decubital ulcer, superficial wounds, and superficial abscesses.
    (2) The ointment should be applied 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. 
Before application, hair in the affected area should be closely clipped 
and the area should be thoroughly cleansed of crusts, scales, dirt, or 
other detritus. When treating infections of the anal gland, the drug 
should be introduced into the orifice of the gland and not through any 
fistulous tract. If no response is evident in 7 days, diagnosis and 
therapy should be reevaluated.
    (3) For use only by or on the order of a licensed veterinarian.

[40 FR 13858, Mar. 27, 1975, as amended at 53 FR 12512, Apr. 15, 1988; 
53 FR 27851, July 25, 1988; 64 FR 404, Jan. 5, 1999]



Sec.  524.1240  Levamisole.

    (a) Specifications. The drug contains 200 milligrams of levamisole 
per milliliter of diethylene glycol monobutyl ether (DGME) solution.
    (b) Sponsor. See 000061 and 053501 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).
    (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]



Sec.  524.1376  2-Mercaptobenzothiazole solution.

    (a) Specifications. The drug contains 1.3 percent 2-
mercaptobenzothiazole in a suitable solvent.
    (b) Sponsor. See 011509 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.

[[Page 307]]

    (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]



Sec.  524.1443  Miconazole nitrate cream; miconazole nitrate lotion; miconazole nitrate spray.

    (a) Specifications. (1) The cream contains 23 milligrams of 
miconazole nitrate (equivalent to 20 milligrams of miconazole base) per 
gram.
    (2) The lotion contains 1.15 percent of miconazole nitrate 
(equivalent to 1 percent miconazole base).
    (3) The spray product consists of a dispensing container, sprayer 
pump assembly, and lotion which contains 1.15 percent of miconazole 
nitrate (equivalent to 1-percent miconazole base).
    (b) Sponsor. See No. 000061 in Sec.  510.600(c) of this chapter for 
use of cream, lotion, and spray; see No. 051259 in Sec.  510.600(c) of 
this chapter for use of lotion and spray.
    (c) Conditions of use. (1) Miconazole nitrate is an antifungal agent 
for topical treatment of infections in dogs and cats caused by 
Microsporum canis, Microsporum gypseum, and Trichophyton mentagrophytes.
    (2) 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.
    (3) Accurate diagnosis of infecting organism is essential. Identify 
by microscopic examination of a mounting of infected tissue in potassium 
hydroxide solution or by culture on an appropriate medium.
    (4) If no improvement is observed in 2 weeks, reevaluate diagnosis 
and therapy.
    (5) Avoid contact with eyes since irritation may result.
    (6) 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 53 FR 26242, July 12, 1988; 
62 FR 55161, Oct. 23, 1997; 62 FR 61626, Nov. 19, 1997]



Sec.  524.1446  Milbemycin oxime 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.
    (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.  524.1451   Moxidectin.

    (a) Specifications. Each milliliter contains 5 milligrams of 
moxidectin (0.5 percent solution).
    (b) Sponsor. See No. 000856 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-(1) Amount. 0.5 milligrams moxidectin per 
kilogram (2.2 pounds) of body weight.
    (2) 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

[[Page 308]]

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.
    (3) Limitations. A withdrawal period has not been established for 
this product on preruminating calves. Do not use on calves to be 
processed for veal.

[63 FR 14036, Mar. 24, 1998, as amended at 65 FR 36617, June 9, 2000; 66 
FR 46370, Sept. 5, 2001]



Sec.  524.1465  Mupirocin ointment.

    (a) Specifications. Each gram contains 20 milligrams of mupirocin.
    (b) Sponsor. See No. 000069 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use--(1) Dogs:
    (i) Indications for use. Topical treatment of bacterial infections 
of the skin, including superficial pyoderma, caused by susceptible 
strains of Staphylococcus aureus and Staphylococcus intermedius.
    (ii) Limitations. Apply twice daily. Treatment should not exceed 30 
days. Because of potential hazard of nephrotoxicity due to polyethylene 
glycol content, care should be exercised in treating deep lesions. 
Safety of use in pregnant or breeding animals has not been determined. 
Not for ophthalmic use. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.
    (2) [Reserved]

[53 FR 39085, Oct. 5, 1988, as amended at 56 FR 50653, Oct. 8, 1991; 60 
FR 55659, Nov. 2, 1995]



Sec.  524.1484  Neomycin sulfate ophthalmic and topical dosage forms.



Sec.  524.1484a  Neomycin sulfate ophthalmic ointment.

    (a) Specifications. Each gram of the ointment contains 5 milligrams 
of neomycin sulfate equivalent in activity to 3.5 milligrams of neomycin 
base.
    (b) Sponsor. See No. 017030 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use. (1) The drug is intended for use in dogs and 
cats for the treatment of superficial ocular bacterial infections 
limited to the conjunctival or the anterior segment of the eye.
    (2) The drug is applied four times each day.
    (3) The drug is applied by inserting the tip of the tube beneath the 
lower lid and by expressing a small quantity of ointment into the 
conjunctival sac. The tip of the tube should not come in contact with 
the eye surface.
    (4) Severe infections should be supplemented by systemic therapy.
    (5) Prolonged administration of the drug may permit overgrowth of 
organisms that are not susceptible to neomycin. If new infections due to 
bacteria or fungi appear during therapy, appropriate measures should be 
taken.
    (6) 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 44 FR 49666, Aug. 24, 1979]



Sec.  524.1484b  Neomycin sulfate, isoflupredone acetate, tetracaine hydrochloride, and myristyl-gamma-picolinium chloride, topical powder.

    (a) Specifications. The product contains 5 milligrams of neomycin 
sulfate, equivalent to 3.5 milligrams of neomycin base, 1 milligram of 
isoflupredone acetate, 5 milligrams of tetracaine hydrochloride and .2 
milligram of myristyl-gamma-picolinium chloride in each gram of the 
product in a special adherent powder base.
    (b) Sponsor. See No. 000009 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use. (1) It is used in horses, dogs, and cats in 
the treatment or adjunctive therapy of certain ear and skin conditions 
when such conditions are caused by or associated with neomycin-
susceptible organisms and/or allergy. In addition the product is 
indicated as superficial dressing applied to minor cuts, wounds, 
lacerations, abrasions, and for postsurgical application where reduction 
of pain and inflammatory response is deemed desirable. The product may 
be used as a dusting powder following amputation of tails, claws, and 
dew-claws and following ear trimming, castrating, and such surgical 
procedures as ovariohysterectomies. The product may also be used in the 
treatment of acute otitis externa in dogs, acute moist dermatitis and 
interdigital dermatitis in dogs.

[[Page 309]]

    (2) 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]



Sec.  524.1484c  Neomycin sulfate, isoflupredone acetate, tetracaine hydrochloride 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. 000009 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use. (1) It is used in treating such conditions as 
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.
    (2) 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.
    (3) Tetracaine and neomycin have the potential to sensitize. Care 
should be taken to observe animals being treated for evidence of 
hypersensitivity or allergy to the drug. If such signs are noted, 
therapy with the drug should be stopped. Treatment should be limited to 
the period when local anesthesia is essential to control self-inflicted 
trauma.
    (4) 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]



Sec.  524.1484d  Neomycin sulfate, hydrocortisone acetate, tetracaine hydrochloride ear 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. 000009 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use. (1) It is indicated for treating acute otitis 
externa and, to a lesser degree, chronic otitis externa in dogs and 
cats. In treatment of ear canker 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.\1\
    (2) Tetracaine and neomycin have the potential to sensitize. Care 
should be taken to observe animals being treated for evidence of 
hypersensitivity or allergy to the product. If such signs are noted, 
therapy with the product should be stopped. Incomplete response or 
exacerbation of corticosteroid responsive lesions may be due to the 
presence of nonsusceptible organisms or to prolonged use of antibiotic-
containing preparations resulting in overgrowth of nonsusceptible 
organisms, particularly Monilia.\1\
---------------------------------------------------------------------------

    \1\ These conditions are NAS/NRC reviewed and deemed effective. 
Applications for these uses need not include effectiveness data as 
specified by Sec.  514.111 of this chapter, but may require 
bioequivalency and safety information.
---------------------------------------------------------------------------

    (3) Federal law restricts this drug to use by or on the order of a 
licensed veterinarian.\1\

[40 FR 13873, Mar. 27, 1975, as amended at 49 FR 21922, May 24, 1984]



Sec.  524.1484e  Neomycin sulfate and polymyxin B sulfate 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. 000856 in Sec.  510.600(c) of this chapter.

[[Page 310]]

    (c) Conditions of use. (1) The drug is recommended for the treatment 
of bacterial infections associated with topical ophthalmological 
conditions such as corneal injuries, superficial keratitis, 
conjunctivitis, keratocon- junctivities, and blepharitis in the dog.
    (2) The recommended dosage is 1 to 2 drops per eye every 6 hours.
    (3) In treating ophthalmological conditions associated with 
bacterial infections the drug is contraindicated in those cases in which 
microorganisms are nonsusceptible to the antibiotics incorporated in the 
drug.
    (4) 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]



Sec.  524.1484f  Neomycin sulfate, prednisolone acetate, tetracaine hydrochloride eardrops.

    (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. 000009 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use. (1) It is useful in treating such conditions 
as acute otitis externa and, to a lesser degree, chronic otitis externa 
in dogs and cats. It is indicated as treatment or adjunctive therapy of 
certain ear conditions in dogs and cats caused by or associated with 
neomycin-susceptible organisms and/or allergy. In otitis externa, 2 to 6 
drops may be placed in the external ear canal two or three times 
daily.\1\
    (2) Incomplete response or exacerbation of corticosteroid responsive 
lesions may be due to the presence of nonsusceptible organisms or to 
prolonged use of antibiotic-containing preparations resulting in 
overgrowth of nonsusceptible organisms, particularly Monilia. Thus, if 
improvement is not noted within 2 or 3 days, or if redness, irritation, 
or swelling persists or increases, the diagnosis should be redetermined 
and appropriate therapeutic measures initiated. Tetracaine and neomycin 
have the potential to sensitize. Care should be taken to observe animals 
being treated for evidence of hypersensitivity or allergy. If such signs 
are noted, therapy should be stopped.\1\
    (3) Federal law restricts this drug to use by or on the order of a 
licensed veterinarian.\1\
---------------------------------------------------------------------------

    \1\ These conditions are NAS/NRC reviewed and deemed effective. 
Applications for these uses need not include effectiveness data as 
specified by Sec.  514.111 of this chapter, but may require 
bioequivalency and safety information.
---------------------------------------------------------------------------



Sec.  524.1484g  Neomycin sulfate-thiabendazole-dexamethasone solution.

    (a) Specifications. Each cubic centimeter of neomycin sulfate-
thiabendazole-dexamethasone solution contains: 40 milligrams of 
thiabendazole, 3.2 milligrams of neomycin (from neomycin sulfate), and 1 
milligram of dexamethasone.
    (b) Sponsor. See No. 050604 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use. (1) The drug is recommended for use as an aid 
in the treatment of bacterial, mycotic, and inflammatory dermatoses and 
otitis externa in dogs and cats.
    (2) In treating dermatoses affecting areas other than the ear, the 
surface of the lesions should be well moistened (two to four drops per 
square inch) twice daily. In treating otitis externa, five to 15 drops 
of the drug should be instilled in the ear twice daily. The drug is 
limited to 7 days maximum duration of administration.
    (3) For use only by or on order of a licensed veterinarian.

[40 FR 13873, Mar. 27, 1975, as amended at 62 FR 63271, Nov. 28, 1997]



Sec.  524.1484h  Neomycin, penicillin, polymyxin, 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 000009 in Sec.  510.600(c) of this chapter.

[[Page 311]]

    (c) Special considerations. The labeling shall state: This 
medication contains penicillin. Allergic reactions in humans are known 
to occur from topical exposure to penicillin.
    (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]



Sec.  524.1484i  Neomycin sulfate, hydrocortisone acetate, sterile 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. No. 000009 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use. (1) Amount. Apply three or four times daily 
into the conjunctival sac. With improvement, frequency may be reduced to 
two or three times daily. For treatment of ear canker and other 
inflammatory conditions of the external ear canal, fill external ear 
canal one to three times daily.\1\
    (2) Indications for use. For treating infections, allergic, and 
traumatic keratitis, conjunctivitis, acute otitis externa and, to a 
lesser degree, chronic otitis externa in dogs and cats.\1\
    (3) Limitations. All topical ophthalmic preparations containing 
corticosteroids, with or without an antimicrobial agent, are 
contraindicated in the initial treatment of corneal ulcers. They should 
not be used until infection is under control and corneal regeneration is 
well underway. Incomplete response or exacerbation of corticosteroid 
responsive lesions may be due to the presence of nonsusceptible 
organisms or to prolonged use on antibiotic-containing preparations 
resulting in overgrowth of nonsusceptible organisms, particularly 
Monilia. Federal law restricts this drug to use by or on the order of a 
licensed veterinarian.\1\

[43 FR 40456, Sept. 12, l978]



Sec.  524.1484j   [Reserved]



Sec.  524.1484k  Neomycin sulfate, prednisolone, tetracaine, and squalane topical-otic suspension.

    (a) Specifications. Each milliliter of suspension contains 5 
milligrams neomycin sulfate (equivalent to 3.5 milligrams neomycin 
base), 2 milligrams prednisolone, 5 milligrams tetracaine, and 0.25 
milliliter squalane.
    (b) Sponsor. See 017030 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use--(1) Amount. 2 to 3 applications daily or as 
needed.
    (2) Indications for use. Indicated for use in dogs and cats for 
treating acute otitis externa and as adjunctive therapy in management of 
chronic otitis externa. The product may also be used for treating moist 
dermatitis in dogs.
    (3) Limitations. Tetracaine and neomycin have the potential to 
sensitize. If signs of irritation or sensitivity develop, discontinue 
use. Prolonged use of this product may result in overgrowth of 
nonsusceptible organisms. If new infections due to bacteria or fungi 
appear during therapy, appropriate measures should be taken. Federal law 
restricts this drug to use by or on the order of a licensed 
veterinarian.

[48 FR 5265, Feb. 4, 1983; 48 FR 8055, Feb. 25, 1983]



Sec.  524.1580  Nitrofurazone ophthalmic and topical dosage forms.



Sec.  524.1580a  [Reserved]



Sec.  524.1580b  Nitrofurazone ointment.

    (a) Specifications. The drug contains 0.2 percent nitrofurazone in a 
water-soluble base.
    (b) Sponsor. For use on dogs, cats, or horses, see Nos. 000010, 
000857, 000864, 000069, 050749, 023851, 051259, and 061623 in Sec.  
510.600(c) of this chapter. For use on dogs and horses, see No. 017135 
in Sec.  510.600(c) of this chapter. For use on

[[Page 312]]

horses, see No. 017153 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 wounds, burns, and 
cutaneous ulcers of dogs, cats, or horses. \1\
    (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 veterinarian. If redness, irritation, or swelling 
persists or increases, discontinue use; consult veterinarian. \1\

[46 FR 43402, June 27, 1980, as amended at 49 FR 6476, Feb. 22, 1984; 50 
FR 49373, Dec. 2, 1985; 52 FR 18691, May 19, 1987; 53 FR 32610, Aug. 26, 
1988; 53 FR 40728, Oct. 18, 1988; 54 FR 29544, July 13, 1989; 54 FR 
37097, Sept. 7, 1989; 55 FR 8462, Mar. 8, 1990; 55 FR 20455, May 17, 
1990; 56 FR 37473, Aug. 7, 1991; 56 FR 50653, Oct. 8, 1991; 59 FR 33197, 
June 28, 1994; 60 FR 55659, Nov. 2, 1995; 62 FR 35077, June 30, 1997; 66 
FR 14074, Mar. 9, 2001; 68 FR 4915, Jan. 31, 2003]



Sec.  524.1580c  Nitrofurazone soluble powder.

    (a) Specifications. The drug contains 0.2 percent nitrofurazone in a 
water-soluble base.
    (b) Sponsor. See Nos. 000010, 000069, and 050749 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. \1\
    (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). 
\1\

[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]



Sec.  524.1580d  [Reserved]



Sec.  524.1580e  Nitrofurazone ointment with butacaine sulfate.

    (a) Specifications. The drug contains 0.2 percent nitrofurazone and 
0.5 percent butacaine sulfate in a water-soluble base.
    (b) Sponsor. See No. 051259 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.\1\
---------------------------------------------------------------------------

    \1\ These conditions are NAS/NRC reviewed and deemed effective. 
Applications for these uses need not include effectiveness data as 
specified by Sec.  514.111 of this chapter, but may require 
bioequivalency and safety information.
---------------------------------------------------------------------------

    (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.\1\

[49 FR 9417, Mar. 13, 1984]



Sec.  524.1600  Nystatin ophthalmic and topical dosage forms.



Sec.  524.1600a  Nystatin, neomycin, thiostrepton, and triamcinolone acetonide ointment.

    (a) Specifications. Each milliliter of petrolatum base or each gram 
of vanishing cream base ointment contains:

[[Page 313]]

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 000069, 000332, 
000856, 025463, 051259, and 053501 in Sec.  510.600(c) of this chapter. 
For vanishing cream base ointments see 051259 and 053501.
    (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. For mild inflammations, use once daily to once a 
week. For severe conditions, apply initially two to three times daily, 
decreasing frequency as improvement occurs. Not intended for treatment 
of deep abscesses or deep-seated infections. Not for ophthalmic use. 
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]



Sec.  524.1600b  Nystatin, neomycin, thiostrepton, and triamcinolone acetonide 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) Conditions of use. (1) The drug is recommended for ophthalmic 
use as an anti-inflammatory, antipruritic, antifungal (Candida 
albicans), and antibacterial ointment for local therapy in keratitis and 
conjunctivitis in cats and dogs and for infectious kerato-conjunctivitis 
(pink eye) in cattle.
    (2) It is to be administered as follows:
    (i) For conjunctivitis and keratitis: Apply one drop of ointment to 
the affected eye(s) two or three times daily. Treatment may be continued 
for up to 2 weeks if necessary.
    (ii) For bovine infectious kerato-conjunctivitis: Apply small line 
of ointment to the affected eye(s) once daily. Treatment may be 
continued for up to 2 weeks if necessary.
    (iii) Frequency of administration is dependent on the severity of 
the condition. For mild inflammations, applications may range from once 
daily to once a week; for severe conditions the drug may be applied as 
often as two to three times daily. Frequency of treatment may be 
decreased as improvement occurs.
    (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]



Sec.  524.1662  Oxytetracycline hydrochloride ophthalmic and topical dosage forms.



Sec.  524.1662a  Oxytetracycline hydrochloride 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

[[Page 314]]

milligrams of oxytetracycline hydrochloride and 0.8 milligram of 
hydrocortisone.
    (b) Sponsor. See No. 000069 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use. (1) The drug is indicated for relief of 
discomfort and continued treatment of many allergic, infectious, and 
traumatic skin conditions. The indications include 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 in dogs and cats.
    (2) 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.
    (3) 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.



Sec.  524.1662b  Oxytetracycline hydrochloride, polymyxin B sulfate 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. 000069 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use. (1) The drug is used for the prophylaxis and 
local treatment of superficial ocular infections due to oxytetracycline- 
and polymyxin-sensitive organisms. These infections include the 
following: 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.
    (2) It is administered topically to the eye two to four times daily.
    (3) 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.



Sec.  524.1742  N-(Mercaptomethyl) phthalimide S-(O,O-dimethyl phosphorodithioate) 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) Conditions of use--(1) Methods of application. Methods of 
application to control the following conditions on beef cattle:

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

[[Page 315]]

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.
    (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

[[Page 316]]

water. Wash all contaminated clothing with soap and hot water before re-
use.
    (d) Related tolerances. See 40 CFR 180.261.

[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]



Sec.  524.1880  Prednisolone-neomycin sulfate ophthalmic ointment.

    (a) Specifications. Prednisolone-neomycin sulfate ophthalmic 
ointment contains 2 milligrams prednisolone and 5 milligrams neomycin 
sulfate (equivalent to 3.5 milligrams neomycin base) in each gram of 
ointment.
    (b) Sponsor. See No. 017030 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use. The drug is recommended for use in 
superficial ocular inflammations or infections limited to the 
conjunctiva or the anterior segment of the eye of cats and dogs, such as 
those associated with allergic reactions or gross irritants. A small 
quantity of the ointment should be expressed into the conjunctival sac 
four times a day for 7 days. After 7 days, if clinical improvement is 
not noted, reevaluation of the diagnosis should be considered. All 
topical ophthalmic preparations containing corticosteroids with or 
without an antimicrobial agent are contraindicated in the initial 
treatment of corneal ulcers. They should not be used until the infection 
is under control and corneal regeneration is well underway. For use only 
by or on the order of a licensed veterinarian.



Sec.  524.1881  Prednisolone acetate ophthalmic and topical dosage forms.



Sec.  524.1881a   [Reserved]



Sec.  524.1881b  Prednisolone acetate-neomycin sulfate sterile suspension.

    (a) Specifications. Prednisolone acetate-neomycin sulfate sterile 
suspension contains 2.5 milligrams of prednisolone acetate and 5 
milligrams of neomycin sulfate (equivalent to 3.5 milligrams of neomycin 
base) in each milliliter of sterile suspension.
    (b) Sponsor. See No. 000009 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use. (1) The drug is indicated for treating 
infectious, allergic and traumatic keratitis and conjunctivitis, acute 
otitis externa, and chronic otitis externa in dogs and cats.
    (2) For beginning treatment of acute ocular inflammations 1 or 2 
drops may be placed in the conjunctival sac 3 to 6 times during a 24 
hour period. When improvement occurs, the dosage may be reduced to 1 
drop 2 to 4 times daily. In otitis externa, 2 to 6 drops may be placed 
in the external ear canal 2 or 3 times daily.
    (3) All topical ophthalmic preparations containing corticosteroids 
with or without an anti-microbial agent are contraindicated in the 
initial treatment of corneal ulcers. They should not be used until 
infection is under control and corneal regeneration is well underway.
    (4) Federal law restricts this drug to use by or on the order of a 
licensed veterinarian.



Sec.  524.1883  Prednisolone sodium phosphate-neomycin sulfate ophthalmic ointment.

    (a) Specifications. Prednisolone sodium phosphate-neomycin sulfate 
ophthalmic 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) in each gram of 
ointment.
    (b) Sponsor. See No. 050604 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use. (1) The drug is recommended for use in 
superficial ocular inflammations or infections limited to the 
conjunctiva or the anterior segment of the eye of cats and dogs, such as 
those associated with allergic reactions or gross irritants.\1\
---------------------------------------------------------------------------

    \1\ These conditions are NAS/NRC reviewed and deemed effective. 
Applications for these uses need not include effectiveness data as 
specified by Sec.  514.111 of this chapter, but may require 
bioequivalency and safety information.
---------------------------------------------------------------------------

    (2) 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

[[Page 317]]

require from a few days to several weeks.\1\
    (3) All topical ophthalmic preparations containing corticosteroids 
with or without an antimicrobial agent are contraindicated in the 
initial treatment of corneal ulcers. They should not be used until the 
infection is under control and corneal regeneration is well underway.\1\
    (4) For use only by or on the order of a licensed veterinarian.\1\

[40 FR 13873, Mar. 27, 1975, as amended at 62 FR 63271, Nov. 28, 1997]



Sec.  524.1982  Proparacaine hydrochloride 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. 053501 in Sec.  510.600(c) of this chapter.
    (c) Special considerations. The longterm toxicity of proparacaine is 
unknown. Prolonged use may possibly delay wound healing.
    (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.
    (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]



Sec.  524.2098  Selamectin.

    (a) Specifications. Each milliliter contains 60 or 120 milligrams of 
selamectin.
    (b) Sponsor. See 000069 in Sec.  510.600(c) of this chapter.
    (c) [Reserved]
    (d) Conditions of use--(1) Amount. 2.7 milligrams of selamectin, 
topically, per pound (6 milligrams 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 and 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.

[64 FR 37401, July 12, 1999, as amended at 64 FR 48707, Sept. 8, 1999; 
65 FR 45282, July 21, 2000]



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)).

[[Page 318]]

    (b) NAS/NRC status. These conditions are NAS/NRC reviewed and found 
effective. NADA's for similar products for these conditions of use need 
not include effectiveness data as specified by Sec.  514.111 of this 
chapter, but may require bioequivalency and safety information.
    (c) Sponsors. See 000061, 017135, 023851, and 050604 in Sec.  
510.600(c) of this chapter.
    (1) Indications for use. For use on dogs 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]



Sec.  524.2350  Tolnaftate cream.

    (a) Specifications. The drug contains 1 percent tolnaftate (2-
naphthyl-N-methyl-N-(3-tolyl) thionocarbamate) in an anhydrous cream 
base.
    (b) Sponsor. See No. 000061 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use. (1) The drug is indicated for treatment of 
ringworm lesions due to Microsporum canis and Microsporum gypseum in 
dogs and cats.
    (2) A small amount of the cream is applied to the affected areas 
once or twice a day for 2 to 4 weeks. The areas to be treated are first 
cleared of exudate and the hair clipped if the areas are not already 
denuded. The cream is massaged into each lesion and immediate 
surrounding area until the cream is no longer visible.
    (3) If no response is seen after 2 weeks of treatment with the drug 
the diagnosis should be reviewed.
    (4) Federal law restricts this drug to use by or on the order of a 
licensed veterinarian.

[43 FR 29289, July 7, 1978, as amended at 52 FR 7833, Mar. 13, 1987]



Sec.  524.2481  Triamcinolone acetonide cream.

    (a) Specifications. Triamcinolone acetonide cream contains 0.1 
percent triamcinolone acetonide in an aqueous vanishing cream base.
    (b) Sponsor. See No. 051259 and 053501 in Sec.  510.600(c) of this 
chapter.
    (c) Conditions of use. (1) The drug is recommended for use on dogs 
as an anti-inflammatory, antipruritic, and antiallergic agent for 
topical treatment of allergic dermatitis and summer eczema.
    (2) The drug is applied by rubbing into affected areas two to four 
times daily for 4 to 10 days.
    (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; 
65 FR 16817, Mar. 30, 2000]



Sec.  524.2482  Triamcinolone spray.

    (a) Specifications. Each milliliter of solution contains 0.15 
milligrams triamcinolone acetonide.
    (b) Sponsor. See No. 067292 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]



Sec.  524.2620  Liquid crystalline trypsin, Peru balsam, castor oil.

    (a)(1) Specifications. The drug is a liquid for direct application 
or an aerosol preparation formulated so that each gram delivered to the 
wound site contains 0.12 milligram of crystalline trypsin, 87.0 
milligrams of Peru balsam, and 788.0 milligrams of castor oil.
    (2) Sponsor. See No. 062794 in Sec.  510.600(c) of this chapter.
    (b)(1) Specifications. The drug is a liquid for direct application 
or an aerosol

[[Page 319]]

preparation formulated so that each gram delivered to the wound site 
contains 0.1 milligram of crystalline trypsin, 72.5 milligrams of Peru 
balsam, and 800 milligrams of castor oil.
    (2) Sponsor. See No. 017135 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use. The drug is used as an aid in the treatment 
of external wounds and assists healing by facilitating the removal of 
necrotic tissue, exudate and organic debris.

[40 FR 13873, Mar. 27, 1975, as amended at 41 FR 56307, Dec. 28, 1976; 
50 FR 9800, Mar. 12, 1985; 54 FR 25565, June 16, 1989; 56 FR 37474, Aug. 
7, 1991; 66 FR 46369, Sept. 5, 2001]



PART 526--INTRAMAMMARY DOSAGE FORMS--Table of Contents




Sec.
526.88 Amoxicillin trihydrate for intramammary infusion.
526.363 Cephapirin benzathine.
526.365 Cephapirin sodium for intramammary infusion.
526.464 Cloxacillin intramammary dosage forms.
526.464a Cloxacillin benzathine for intramammary infusion.
526.464b Cloxacillin benzathine for intramammary infusion, sterile.
526.464c Cloxacillin sodium for intramammary infusion, sterile.
526.464d Cloxacillin sodium for intramammary infusion.
526.820 Erythromycin.
526.1130 Hetacillin potassium for intramammary infusion.
526.1590 Novobiocin oil suspension.
526.1696 Penicillin intramammary dosage forms.
526.1696a Penicillin G procaine in oil.
526.1696b Penicillin G procaine-dihydrostreptomycin in soybean oil for 
          intramammary infusion (dry cows).
526.1696c Penicillin G procaine-dihydrostreptomycin sulfate for 
          intramammary infusion (dry cows).
526.1696d Penicillin G procaine-novobiocin for intramammary infusion.
526.1810 Pirlimycin hydrochloride.

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



Sec.  526.88  Amoxicillin trihydrate for intramammary infusion.

    (a) Specifications. Each single dose syringe contains amoxicillin 
trihydrate equivalent to 62.5 milligrams of amoxicillin.
    (b) Sponsor. See No. 000069 in Sec.  510.600(c) of this chapter.
    (c) Related tolerances. See Sec.  556.38 of this chapter.
    (d) Conditions of use--Lactating cows--(1) Amount. One syringe 
(equivalent to 62.5 milligrams amoxicillin) per quarter.
    (2) Indications for use. For the treatment of subclinical infectious 
bovine mastitis due to Streptococcus agalactiae and Straphylococcus 
aureus (penicillin sensitive).
    (3) Limitations. Administer after milking. Clean and disinfect the 
teat. Use one syringe per infected quarter every 12 hours for a maximum 
of 3 doses. Do not use milk taken from treated animals for food purposes 
within 60 hours (5 milkings) after last treatment. Do not slaughter 
treated animals 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]



Sec.  526.363  Cephapirin benzathine.

    (a) Specifications. Each 10 milliliter disposable syringe contains 
300 milligrams of cephapirin activity (as cephapirin benzathine) in a 
peanut-oil gel.
    (b) Sponsor. See No. 000856 in Sec.  510.600(c) of this chapter.
    (c) Related tolerances. See Sec.  556.115 of this chapter.
    (d) Conditions of use--(1) Amount. Infuse contents of one syringe 
into each infected quarter.
    (2) Indications for use. Use in dry cows for treatment of mastitis 
caused by susceptible strains of Streptococcus agalactiae and 
Staphylococcus aureus.
    (3) Limitations. Infuse each infected quarter following last milking 
or early in the dry period, but no later than 30 days before calving. 
Milk from treated cows must not be use 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. For use in 
dry cows only.

[43 FR 37174, Aug. 22, 1978, as amended at 53 FR 27851, July 25, 1988]

[[Page 320]]



Sec.  526.365  Cephapirin sodium for intramammary infusion.

    (a) Specifications. Each 10-milliliter dose contains 200 milligrams 
of cephapirin sodium activity in a peanut-oil gel.
    (b) Sponsor. See No. 000856 in Sec.  510.600(c) of this chapter.
    (c) Related tolerances. See Sec.  556.115 of this chapter.
    (d) Conditions of use. (1) The drug is used for the treatment of 
lactating cows having bovine mastitis caused by susceptible strains of 
Streptococcus agalactiae and Staphylococcus aureus.
    (2) Administer one dose 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. If improvement is not noted within 
48 hours after treatment, consult your veterinarian.
    (3) 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]



Sec.  526.464  Cloxacillin intramammary dosage forms.



Sec.  526.464a  Cloxacillin benzathine for intramammary infusion.

    (a) Specifications. Each dose contains cloxacillin benzathine 
equivalent to 500 milligrams of cloxacillin.
    (b) Related tolerances. See Sec.  556.165 of this chapter.
    (c) Sponsor. See No. 000856 in Sec.  510.600(c) of this chapter for 
use in dairy cows.
    (1) Amount. Administer aseptically into each infected quarter 
immediately after last milking or early in dry period.
    (2) Indications for use. Treatment of mastitis caused by 
Staphylococcus aureus and Streptococus agalactiae including penicillin 
resistant strains in dairy cows during the dry period.
    (3) Limitations. For use in dry cows only. Not to be used within 30 
days of calving. Animals infused with this product must not be 
slaughtered for food use for 30 days after the latest infusion. Federal 
law restricts this drug to use by or on the order of a licensed 
veterinarian.
    (d) Sponsor. See No. 000069 in Sec.  510.600(c) of this chapter for 
use in dairy cows.
    (1) Amount. Administer one dose in each quarter immediately after 
last milking.
    (2) Indications for use. Treatment and prophylaxis of bovine 
mastitis in nonlactating cows due to S. agalactiae and S. aureus.
    (3) Limitations. For use in dry cows only. Not to be used within 4 
weeks (28 days) of calving. Animals infused with this product must not 
be slaughtered for food use for 4 weeks (28 days) after the latest 
infusion. Federal law restricts this drug to use by or on the order of a 
licensed veterinarian.

[57 FR 37334, Aug. 18, 1992; 57 FR 42623, Sept. 15, 1992, as amended at 
60 FR 55660, Nov. 2, 1995]



Sec.  526.464b  Cloxacillin benzathine for intramammary infusion, sterile.

    (a) Specifications. Each 6 milliliter dose contains cloxacillin 
benzathine equivalent to 500 milligrams of cloxacillin.
    (b) Related tolerances. See Sec.  556.165 of this chapter.
    (c) Sponsor. See No. 055529 in Sec.  510.600(c) of this chapter.
    (1) Amount. 6 milliliters per infected quarter aseptically 
immediately after last milking at the time of drying-off of the cow.
    (2) Indications for use. Treatment of mastitis caused by 
Staphylococcus aureus and Streptococus agalactiae in dairy cows at the 
time of drying-off of the cow.
    (3) Limitations. For use in dry cows only. Not to be used within 30 
days of calving. Milk taken from treated cows prior to 72 hours (6 
milkings) after calving must not be used for human food. Animals infused 
with this product must not be slaughtered for food from the time of 
infusion until 72 hours after calving. Federal law restricts this drug 
to use by or on the order of a licensed veterinarian.
    (d) Sponsor. See No. 000069 in Sec.  510.600(c) of this chapter.

[[Page 321]]

    (1) Amount. One dose per infected quarter immediately after last 
milking.
    (2) Indications for use. Treatment and prophylaxis of bovine 
mastitis in nonlactating cows due to Streptococcus agalactiae and 
Staphylococcus aureus.
    (3) Limitations. For use in dry cows only. Not to be used within 4 
weeks (28 days) of calving. Animals infused with this product must not 
be slaughtered for food use for 4 weeks (28 days) after the latest 
infusion. Federal law restricts this drug to use by or on the order of a 
licensed veterinarian.

[57 FR 37334, Aug. 18, 1992; 57 FR 42623, Sept. 15, 1992, as amended at 
58 FR 61016, Nov. 19, 1993; 60 FR 55660, Nov. 2, 1995]



Sec.  526.464c  Cloxacillin sodium for intramammary infusion, sterile.

    (a) Specifications. Each milliliter contains cloxacillin sodium 
equivalent to 20.0 milligrams of cloxacillin.
    (b) Sponsor. See No. 000069 in Sec.  510.600(c) of this chapter.
    (c) Related tolerances. See Sec.  556.165 of this chapter.
    (d) Conditions of use. Lactating cows--(1) Amount. 10 milliliters 
(one dose of 200 milligrams) per infected quarter.
    (2) Indications for use. Treatment of mastitis in lactating cows due 
to Streptococcus agalactiae and Staphylococcus aureus, nonpenicillinase-
producing strains.
    (3) Limitations. Administer after milking, cleaning, and 
disinfecting, and as early as possible after detection. Treatment should 
be repeated at 12-hour intervals for a total of three doses. Milk taken 
from treated animals within 48 hours (four 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]



Sec.  526.464d  Cloxacillin sodium for intramammary infusion.

    (a) Specifications. Each milliliter contains cloxacillin sodium 
equivalent 20.0 milligrams of cloxacillin.
    (b) Sponsor. See No. 000069 in Sec.  510.600(c) of this chapter.
    (c) Related tolerances. See Sec.  556.165 of this chapter.
    (d) Conditions for use. Lactating cows--(1) Amount. 10 milliliters 
(one dose of 200 milligrams) per infected quarter.
    (2) Indications for use. Treatment of mastitis in lactating cows due 
to Streptococcus agalactiae and Staphylococcus aureus, nonpenicillinase-
producing strains.
    (3) Limitations. Administer after milking, cleaning, and 
disinfecting, and as early as possible after detection. Treatment should 
be repeated at 12-hour intervals for a total of three doses. 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]



Sec.  526.820  Erythromycin.

    (a) Specifications. (1) Each 6-milliliter, single-dose, disposable 
syringe contains 300 milligrams of erythromycin (as the base), 0.45 
milligram of butylated hydroxyanisole, and 0.45 milligram of butylated 
hydroxytoluene.
    (2) Each 12-milliliter, single-dose, disposable syringe contains 600 
milligrams of erythromycin (as the base), 0.90 milligram of butylated 
hydroxyanisole, and 0.90 milligram of butylated hydroxytoluene.
    (3) The vehicle is triglyceride of saturated fatty acids from 
coconut oil.
    (4) The drug may or may not be sterile.
    (b) Sponsor. See No. 061623 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use--(1) Amount. (i) Lactating cows: After 
milking, cleaning, and disinfecting, infuse contents of a single 6-
milliliter syringe into each infected quarter; repeat procedure at 12-
hour intervals for a maximum of 3 consecutive infusions.
    (ii) Dry cows: After milking, cleaning, and disinfecting, infuse 
contents of a single 12-milliliter syringe into each infected quarter at 
the time of drying off.
    (2) Indications for use. Treatment of mastitis due to Staphylococcus 
aureus,

[[Page 322]]

Streptococcus agalactiae, Streptococcus dysgalactiae, and Streptococcus 
uberis in lactating or dry 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.

[47 FR 15772, Apr. 13, 1982, as amended at 66 FR 14074, Mar. 9, 2001; 68 
FR 4915, Jan. 31, 2003]



Sec.  526.1130  Hetacillin potassium for intramammary infusion.

    (a) Specifications. Each 10 milliliter syringe contains hetacillin 
potassium equivalent of 62.5 milligrams of ampicillin.
    (b) Sponsor. See No. 000856 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use. Lactating cows--(1) Amount. 10 milliliters of 
hetacillin potassium equivalent to 62.5 milligrams ampicillin into each 
infected quarter. Repeat at 24-hour intervals until a maximum of three 
treatments has been given.
    (2) Indications for use. Treating acute, chronic, or subclinical 
bovine mastitis in lactating cows caused by susceptible strains of 
Streptococcus agalactiae, Streptococcus dysgalactiae, Staphylococcus 
aureus, and Escherichia coli.
    (3) Limitations. If definite improvement is not noted within 48 
hours after treatment, the causal organism should be further 
investigated. 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]



Sec.  526.1590  Novobiocin oil suspension.

    (a)(1) Specifications. Each 10 milliliters of oil suspension 
contains the equivalent of 400 milligrams of novobiocin (present as 
sodium novobiocin).
    (2) Sponsor. See No. 000009 in Sec.  510.600(c) of this chapter.
    (3) Related tolerances. See Sec.  556.460 of this chapter.
    (4) Conditions of use--(i) Amount. Ten milliliters (equivalent to 
400 milligrams of novobiocin) infused in each quarter.
    (ii) Indications for use. It is used in dry cows for the treatment 
of mastitis caused by susceptible strains of Staphylococcus aureus and 
Streptococcus agalactiae.
    (iii) Limitations. 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 use for 30 days following udder infusion. For udder 
installation for the treatment of mastitis in dry cows only.
    (b)(1) Specifications. Each 10 milliliters of oil suspension 
contains the equivalent of 150 milligrams of novobiocin (present as 
sodium novobiocin).
    (2) Sponsor. See No. 000009 in Sec.  510.600(c) of this chapter.
    (3) Related tolerances. See Sec.  556.460 of this chapter.
    (4) Conditions of use--(i) Amount. Infuse 10 milliliters (equivalent 
to 150 milligrams of novobiocin) in each quarter after milking. Repeat 
treatment once after 24 hours.
    (ii) Indications for use. Use in lactating cows for treatment of 
mastitis caused by susceptible strains of Staphylococcus aureus.
    (iii) Limitations. Do not milk for at least 6 hours after treatment; 
afterwards, milk at regular intervals. Milk taken from treated animals 
within 72 hours (6 milkings) after latest treatment must not be used for 
food. Do not slaughter treated animals for food for 15 days following 
latest treatment. If redness, swelling, or abnormal milk persists or 
increases after treatment, discontinue use and consult a veterinarian. 
For udder instillation in lactating cattle only. Federal law restricts 
this drug to use by or on the order of a licensed veterinarian.

[43 FR 10554, Mar. 14, 1978]



Sec.  526.1696  Penicillin intramammary dosage forms.



Sec.  526.1696a  Penicillin G procaine in oil.

    (a) Specifications. Each milliliter contains penicillin G procaine 
equivalent to 100,000 units of penicillin G in peanut, sesame, or 
soybean oils.

[[Page 323]]

    (b) Related tolerances. See Sec.  556.510 of this chapter.
    (c) Sponsor. See No. 010515 in Sec.  510.600(c) of this chapter.
    (1) National Academy of Sciences/National Research Council (NAS/NRC) 
status. The conditions specified in paragraph (c)(2)(i)(B) of this 
section were NAS/NRC reviewed and found effective. Applications for 
these uses need not include effectiveness data as specified by Sec.  
514.111 of this chapter, but may require bioequivalency and safety 
information.
    (2) Conditions of use. Treating bovine mastitis caused by 
Streptococcus agalactiae, S. dygalactiae, and S. uberus in lactating 
cows as follows:
    (i) Three-dose regimen. Administer by intramammary infusion in each 
infected quarter as follows:
    (A) 6-milliliter dose (peanut oil). Treatment may be repeated at 12-
hour intervals. Milk that has been taken from animals during treatment 
and for 84 hours (7 milkings) after the latest treatment must not be 
used for food. Animals must not be slaughtered for food during treatment 
or within 4 days after the latest treatment.
    (B) 10-milliliter dose (sesame oil). Treatment may be repeated at 
12-hour intervals. Milk that has been taken from animals during 
treatment and for 60 hours (5 milkings) after the latest treatment must 
not be used for food. Animals must not be slaughtered for food during 
treatment or within 3 days after the latest treatment.
    (ii) Two-dose regimen. 10-milliliter dose (peanut oil). Administer 
by intramammary infusion in each infected quarter. Treatment may be 
repeated at intervals of 12 hours. Milk taken from animals during 
treatment and for 60 hours (5 milkings) after the latest treatment must 
not be used for food. Animals must not be slaughtered for food during 
treatment or within 4 days after latest treatment.
    (d) Sponsor. See No. 050604 in Sec.  510.600(c) of this chapter.
    (1) 10-milliliter dose (peanut oil). Administer by intramammary 
infusion in each infected quarter. Treatment may be repeated at 12-hour 
intervals for not more than three doses, as indicated by clinical 
response.
    (2) Indications for use. Treating bovine mastitis caused by 
Streptococcus agalactiae, S. dysgalactiae, and S. uberus in lactating 
cows as follows:
    (3) Limitations. Milk that has been taken from animals during 
treatment and for 60 hours after the latest treatment must not be used 
for food. Animals must not be slaughtered for food during treatment or 
within 3 days after the latest treatment.
    (e) Sponsor. See No. 010515 (sesame oil) and No. 050604 (peanut oil) 
in Sec.  510.600(c) of this chapter.
    (1) NAS/NRC status. The conditions of use were NAS/NRC reviewed and 
found effective. Applications for these uses need not include 
effectiveness data as specified by Sec.  514.111 of this chapter, but 
may require bioequivalency and safety information.
    (2) Single-dose regimen. One 10-milliliter dose (sesame oil or 
peanut oil) in each infected quarter at time of drying-off.
    (3) Indications of use. Treating bovine mastitis caused by 
Streptococcus agalactiae in dry cows.
    (4) Limitations. Discard all milk for 72 hours (6 milkings) 
following calving, or later as indicated by the marketable quality of 
the milk. Animals must not be slaughtered for food within 14 days 
postinfusion.

[57 FR 37335, Aug. 18, 1992, as amended at 58 FR 500, Jan. 6, 1993]



Sec.  526.1696b  Penicillin G procaine-dihydrostreptomycin in soybean oil for intramammary infusion (dry cows).

    (a) Specifications. Each 10 milliliters of suspension contains 
penicillin G procaine equivalent to 200,000 units of penicillin G and 
dihydrostreptomycin sulfate equivalent to 300 milligrams of 
dihydrostreptomycin.
    (b) Sponsor. See No. 000010 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. Dairy cows--(1) Amount. One syringe into each 
quarter at the last milking prior to drying off.
    (2) Indications for use. Intramammary treatment of subclinical 
mastitis in dairy cows at the time of drying off, specifically against 
infections caused by Staphylococcus aureus and Streptococcus agalactiae.

[[Page 324]]

    (3) Limitations. Not to be used within 6 weeks of calving. For use 
in dry cows only. 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 nor within 
24 hours after calving.

[57 FR 37336, Aug. 18, 1992]



Sec.  526.1696c  Penicillin G procaine-dihydrostreptomycin sulfate for intramammary infusion (dry cows).

    (a) Specifications. Each 10 milliliters of suspension contains 
penicillin G procaine equivalent to 1 million units of penicillin G and 
dihydrostreptomycin sulfate equivalent to 1 gram of dihydrostreptomycin.
    (b) Sponsor. See No. 033392 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. Dairy cows--(1) Amount. One syringe per 
quarter at the last milking prior to drying off.
    (2) Indications for use. Intramammary use to reduce the frequency of 
existing infection and to prevent new infections with Staphylococcus 
aureus in dry cows.
    (3) Limitations. Not to be used within 6 weeks of freshening. Not 
for use in lactating cows. Milk taken from animals within 96 hours (8 
milkings) after calving must not be used for feed. Animals infused with 
this drug must not be slaughtered for food within 60 days from the time 
of infusion nor 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; 57 FR 42623, Sept. 15, 1992]



Sec.  526.1696d  Penicillin G procaine-novobiocin for intramammary infusion.

    (a) Specifications. For lactating cattle: each 10-milliliter dose 
contains 100,000 units of penicillin G procaine and 150 milligrams of 
novobiocin as novobiocin sodium. For dry cows: 200,000 units of 
penicillin G procaine and 400 milligrams of novobiocin as novobiocin 
sodium.
    (b) Sponsor. See No. 000009 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use--(1) Lactating cows--(i) Amount. 10 
milliliters in each infected quarter after milking. Repeat once after 24 
hours.
    (ii) Indications for use. Treating lactating cows for mastitis 
caused by susceptible strains of Staphylococcus aureus, Streptococcus 
agalactiae, Streptococcus dysgalactiae, and Streptococcus uberis.
    (iii) Limitations. For udder instillation in lactating cattle 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.
    (2) Dry cows--(i) Amount. 10 milliliters in each quarter at time of 
drying off.
    (ii) Indications for use. Treatment of subclinical mastitis caused 
by susceptible strains of Staphylococcus aureus and Streptococcus 
agalactiae.
    (iii) 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]



Sec.  526.1810  Pirlimycin hydrochloride.

    (a) Specifications. Each 10-milliliter syringe contains 50 
milligrams of pirlimycin (as pirlimycin hydrochloride).
    (b) Sponsor. See 000009 in Sec.  510.600(c) of this chapter.
    (c) Related tolerances. See Sec.  556.515 of this chapter.
    (d) Conditions of use. (1) Dose. 50 milligrams in each infected 
quarter, repeated once after 24 hours.
    (2) Indications for use. For lactating dairy cattle for the 
treatment of clinical and subclinical mastitis caused by Staphylococcus 
species, such as Staphylococcus aureus; and Streptococcus species, such 
as Streptococcus agalactiae, Streptococcus dysgalactiae, and 
Streptococcus uberis.

[[Page 325]]

    (3) Limitations. Milk taken from animals during treatment and for 36 
hours following the last treatment must not be used for food. Treated 
animals must not be slaughtered for food use for 9 days following the 
last treatment. 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]



PART 529--CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS--Table of Contents




Sec.
529.40 Albuterol.
529.50 Amikacin sulfate intrauterine solution.
529.400 Chlorhexidine tablets and suspension.
529.469 Competitive exclusion culture.
529.1003 Flurogestone acetate-impregnated vaginal sponge.
529.1030 Formalin.
529.1044 Gentamicin sulfate in certain other dosage forms.
529.1044a Gentamicin sulfate intrauterine solution.
529.1044b Gentamicin sulfate solution.
529.1115 Halothane.
529.1186 Isoflurane.
529.1526 Nifurpirinol capsules.
529.1940 Progesterone intravaginal inserts.
529.2090 Salicylic acid.
529.2150 Sevoflurane.
529.2464 Ticarcillin powder.
529.2503 Tricaine methanesulfonate.

    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) Special considerations. Federal law restricts this drug to use 
by or on the order of a licensed veterinarian.
    (d) 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) Limitations. Not for use in horses intended for food.

[67 FR 7072, Feb. 15, 2002]



Sec.  529.50  Amikacin sulfate intrauterine solution.

    (a) Specifications. Each milliliter of sterile aqueous solution 
contains 250 milligrams of amikacin (as the sulfate).
    (b) Sponsor. See No. 000856 and 059130 in Sec.  510.600(c) of this 
chapter.
    (c) Conditions of use--(1) Amount. Two grams (8 milliliters) diluted 
with 200 milliliters of sterile physiological saline per day for 3 
consecutive days.
    (2) Indications for use. For treating genital tract infections 
(endometritis, metritis, and pyometra) in mares when caused by 
susceptible organisms including E. coli, Pseudomonas spp., and 
Klebsiella spp.
    (3) Limitations. For intrauterine infusion in the horse only. Not 
for use in horses intended for food. Federal law restricts this drug to 
use by or on the order of a licensed veterinarian.

[48 FR 9640, Mar. 8, 1983, as amended at 53 FR 27852, July 25, 1988; 62 
FR 15110, Mar. 31, 1997; 62 FR 23358, Apr. 30, 1997]



Sec.  529.400  Chlorhexidine tablets and suspension.

    (a) Specification. Each tablet and each 28-milliliter syringe of 
suspension contain 1 gram of chlorhexidine dihydrochloride.\1\
---------------------------------------------------------------------------

    \1\ These conditions are NAS/NRC reviewed and deemed effective. 
Applications for these uses need not include effectiveness data as 
specified by Sec.  514.111 of this chapter, but may require 
bioequivalency and safety information.
---------------------------------------------------------------------------

    (b) Sponsor. See No. 000856 in Sec.  510.600(c) of this chapter.
    (c) 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.\1\
    (2) Indications for use. For prevention or treatment of metritis and 
vaginitis in cows and mares when caused by

[[Page 326]]

pathogens sensitive to chlorhexidine dihydrochloride.\1\
    (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.\1\

[43 FR 10705, Feb. 23, 1979]



Sec.  529.469  Competitive exclusion culture.

    (a) Specifications. Each packet of lyophilized culture contains 
either 2,000 or 5,000 doses in frozen pellets to be reconstituted for 
use.
    (1) For 2,000-dose packet, add contents of one 2,000-dose packet of 
reconstitution powder to 490 milliliters of deionized water. Mix. Add 
contents of one 2,000-dose packet of lyophilized culture. Mix 
thoroughly.
    (2) For 5,000-dose packet, add contents of one 5,000-dose packet of 
reconstitution powder to 1,250 milliliters of deionized water. Mix. Add 
contents of one 5,000-dose packet of lyophilized culture. Mix 
thoroughly. Allow to stand for 45 minutes before use. Use within 5 hours 
of reconstitution.
    (b) Sponsor. See No. 032761 in Sec.  510.600(c) of this chapter.
    (c) [Reserved]
    (d) Conditions of use. Chickens--(1) Amount. Apply 25 milliliters of 
reconstituted culture as a topical spray on each tray of 100 chicks 
(0.25 milliliter per chick).
    (2) Indications for use. For early establishment of intestinal 
microflora in chickens to reduce Salmonella colonization.
    (3) Limitations. Administer as soon as possible after hatch, 
preferably at less than 1 day of age. Expose chicks to light for at 
least 5 minutes after spray treatment to encourage preening for oral 
uptake of the organisms. Provide access to feed and water as soon as 
possible after treatment. Do not administer antibiotics to treated 
chickens.

[63 FR 25164, May 7, 1998]



Sec.  529.1003  Flurogestone acetate-impregnated vaginal sponge.

    (a) Specifications. Each vaginal sponge contains 20 milligrams of 
flurogestone acetate.
    (b) Sponsor. See No. 000014 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use--(1) Indications for use. For synchronizing 
estrus/ovulation in cycling adult ewes during their normal breeding 
season.
    (2) Limitations. Using applicator provided, insert sponge into ewe's 
vagina 13 days before desired start of breeding. For intravaginal use in 
sheep only. Do not use in young ewes that have not had lambs. Use 
plastic or rubber gloves when handling large numbers of sponges to 
minimize exposure to drug. Do not leave sponge in the vagina for more 
than 21 days. Ewes must not be slaughtered for food within 30 days of 
sponge removal.

[49 FR 45420, Nov. 16, 1984]



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) Nos. 049968 and 050378 for use as in paragraphs (d)(1)(iii), 
(d)(1)(iv), (d)(1)(v), (d)(2)(iii), (d)(2)(iv), (d)(2)(v), and (d)(3).
    (2) No. 051212 for use as in paragraphs (d)(1)(i), (d)(1)(ii), 
(d)(2)(i), (d)(2)(ii), and (d)(3).
    (c) [Reserved]
    (d) Conditions of use. It is added to environmental water as 
follows:
    (1) Indications for use. (i) Select finfish. For control of external 
protozoa Ichthyophthirius spp., Chilodonella spp., Costia spp., 
Scyphidia spp., Epistylis spp., and Trichodina spp., and monogenetic 
trematodes Cleidodiscus spp., Gyrodactylus spp., and Dactylogyrus spp., 
on salmon, trout, catfish, largemouth bass, and bluegill.
    (ii) Select finfish eggs. For control of fungi of the family 
Saprolegniaceae on salmon, trout, and esocid eggs.

[[Page 327]]

    (iii) Penaeid shrimp. For control of external protozoan parasites 
Bodo spp., Epistylis spp., and Zoothamnium spp.
    (iv) All finfish. For control of external protozoa Ichthyophthirius 
spp., Chilodonella spp., Costia spp., Scyphidia spp., Epistylis spp., 
and Trichodina spp., and monogenetic trematodes Cleidodiscus spp., 
Gyrodactylus spp., and Dactylogyrus spp.
    (v) All finfish eggs: For control of fungi of the family 
Saprolegniaceae.
    (2) Amount. The drug concentrations required are as follows:
    (i) For control of external parasites on select finfish:

------------------------------------------------------------------------
                                          Concentration of formalin
                                           (microliters per liter)
                                   -------------------------------------
               Fish                  Tanks and raceways
                                      (for up to 1 hour    Earthen ponds
                                           daily)         (indefinitely)
------------------------------------------------------------------------
Salmon and trout:
    Above 50 [deg]F...............  Up to 170...........          15-25
    Below 50 [deg]F...............  Up to 250...........          15-25
    Catfish, largemouth bass, and   Up to 250...........      \1\ 15-25
     bluegill.
------------------------------------------------------------------------
\1\ Use the lower concentrations when pond is heavily loaded with fish
  or phytoplankton.

    (ii) For control of fungi of the Saprolegniaceae on salmon, trout, 
and esocid eggs: Apply in constant flow water supply of incubating 
facilities for 15 minutes. Concentration of formalin used is 1,000 to 
2,000 microliters per liter.
    (iii) For control of external protozoan parasites on shrimp:

------------------------------------------------------------------------
                                         Concentration of formalin
                                          (microliters per liter)
                                 ---------------------------------------
              Shrimp                   Tanks and
                                   raceways (up to 4     Earthen ponds
                                     hours daily)     (single treatment)
------------------------------------------------------------------------
Penaeid Shrimp..................   50 to 1001.......  252
------------------------------------------------------------------------
\1\Treat for up to 4 hours daily. Treatment may be repeated daily until
  parasite control is achieved. Use the lower concentration when the
  tanks and raceways are heavily loaded.
\2\Single treatment. Treatment may be repeated in 5 to 10 days if
  needed.

    (iv) For control of external parasites on all finfish:

------------------------------------------------------------------------
                          Administer in tanks
                        and raceways for up to    Administer in earthen
                             1 [chyph]hour                ponds
    Aquatic species      (microliter/liter or      [chyph]indefinitely
                           part per million         ([mu]L/L or ppm)
                           ([mu]L/L or ppm))
------------------------------------------------------------------------
Salmon and trout:       ......................  ........................
 Above 50 [deg]F        Up to 170               15 to 251, 2
Below 50 [deg]F         Up to 250               15 to 251, 2
All other finfish       Up to 250               15 to 251, 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.

    (v) For control of fungi of the family Saprolegniaceae on all 
finfish eggs: Eggs of all finfish except Acipenseriformes, 1,000 to 
2,000 [mu]L/L (ppm) for 15 minutes; eggs of Acipenseriformes, up to 
1,500 [mu]L/L (ppm) for 15 minutes.
    (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 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. Do not treat ponds containing striped bass. 
Treatments in tanks should never exceed 1 hour even if fish show no 
signs of stress. 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]



Sec.  529.1044  Gentamicin sulfate in certain other dosage forms.



Sec.  529.1044a  Gentamicin sulfate intrauterine solution.

    (a) Specifications. Each milliliter of the drug contains 50 or 100 
milligrams of gentamicin (as the sulfate) in sterile aqueous solution.
    (b) Sponsor. See Nos. 000010, 000061, 000856, 000864, 057561, and 
059130 in Sec.  510.600(c) of this chapter.

[[Page 328]]

    (c) Conditions of use. (1) The drug is indicated for use for control 
of bacterial infections of the uterus in horses (metritis) and as an aid 
in improving conception in mares with uterine infections caused by 
bacteria sensitive to gentamicin.
    (2) It is administered at a dosage level of 2 to 2.5 grams per day 
for 3 to 5 days during estrus, each dose being diluted with 200 to 500 
milliliters of sterile physiological saline before aseptic infusion into 
the uterus.
    (3) Federal law restricts this drug to use by or on the order of a 
licensed veterinarian.
    (4) Not for use in horses intended for food.

[40 FR 13881, Mar. 27, 1975, as amended at 40 FR 48676, Oct. 17, 1975; 
48 FR 31386, July 8, 1983; 52 FR 7833, Mar. 13, 1987; 58 FR 14314, Mar. 
17, 1993; 59 FR 31140, June 17, 1994; 60 FR 45042, Aug. 30, 1995; 60 FR 
48894, Sept. 21, 1995; 61 FR 17830, Apr. 23, 1996; 62 FR 611, Jan. 6, 
1997; 62 FR 35077, June 30, 1997; 63 FR 6644, Feb. 10, 1998]



Sec.  529.1044b  Gentamicin sulfate solution.

    (a) Specifications. Each milliliter of solution contains gentamicin 
sulfate equivalent to 50 milligrams of gentamicin base.
    (b) Sponsor. See Nos. 000061 and 051259 in Sec.  510.600(c) of this 
chapter.
    (c) Conditions of use. (1) The drug is recommended as an aid in the 
reduction or elimination of the following microorganisms from turkey-
hatching eggs: Arizona hinshawii (paracolon), Salmonella st. paul, and 
Mycoplasma meleagridis.
    (2) 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.
    (3) 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]



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 000856 and 012164 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.\1\
---------------------------------------------------------------------------

    \1\ These conditions have been reviewed by FDA and found effective. 
NADA's for similar products for these conditions of use need not include 
effectiveness data as specified by Sec.  514.111 of this chapter, but 
may require bioequivalency and safety information.
---------------------------------------------------------------------------

    (2) Indications for use. For nonfood animals for the induction and 
maintenance of anesthesia.\1\
    (3) Limitations. Administered by inhalation. May be administered 
with either oxygen or a mixture of oxygen and nitrous oxide. Place drug 
vaporizer between the gas supply and breathing bag to prevent 
overdosage. Not recommended for obstetrical anesthesia except when 
uterine relaxation is required. Do not use in pregnant animals; 
information on possible adverse effects on fetal development is not 
available. Operating rooms should have adequate ventilation to prevent 
accumulation of anesthetic gases. Not for use in animals intended for 
food. Federal law restricts this drug to use by or on the order of a 
licensed veterinarian.\1\

[46 FR 27915, May 22, 1981, as amended at 62 FR 29014, May 29, 1997]



Sec.  529.1186  Isoflurane.

    (a) Specifications. The drug is a clear, colorless, stable liquid 
containing no additives or chemical stabilizers. It is nonflammable and 
nonexplosive.
    (b) Sponsors. See Nos. 000074, 000209, 010019, 012164, 059258, and 
060307 in Sec.  510.600(c) of this chapter.

[[Page 329]]

    (c) Conditions of use--(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. Administer by inhalation; not for use in horses or 
dogs sensitive to halogenated agents; increasing depth of anesthesia may 
increase hypotension and respiratory depression; use less than usual 
amounts of nondepolarizing relaxants; use with vaporizers producing 
predictable percentage concentrations; not for use in horses intended 
for food; 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]



Sec.  529.1526  Nifurpirinol capsules.

    (a) Specifications. Each capsule contains 3.8 or 7.6 milligrams of 
nifurpirinol.
    (b) Sponsor. See No. 000074 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use. (1) The drug is used in treating aquarium 
fish for the control of columnaris disease caused by Chondrococcus 
columnaris susceptible to nifurpirinol.
    (2) Use one 3.8 milligram nifurpirinol capsule for each 10 gallons 
of aquarium water. Empty the contents of the capsule directly into the 
water and stir briefly. Treat for at least 1 hour. If activated charcoal 
or carbon filtration is being used, disconnect during treatment, but 
maintain adequate aeration. Resume water filtration after 1 hour 
treatment. Usually a single treatment is sufficient. For aquariums with 
charcoal filters, nifurpirinol can be used once each 24 hours up to 3 
consecutive days, discontinuing filtration during treatment. If aquarium 
does not have charcoal filter, do not retreat within 5 days.
    (3) Do not use in salt water aquariums.
    (4) Do not use while egg bearers or live bearers are reproducing.

[40 FR 60052, Dec. 31, 1975, as amended at 47 FR 20758, May 14, 1982; 56 
FR 43699, Sept. 4, 1991]



Sec.  529.1940  Progesterone intravaginal inserts.

    (a) Specifications. Each insert contains 1.38 grams of progesterone 
in molded silicone over a nylon spine.
    (b) Sponsor. See No. 000009 in Sec.  510.600(c) of this chapter.
    (c) Related tolerances. See Sec.  556.540(a) of this chapter.
    (d) Special considerations. (1) Wear latex gloves when handling 
inserts. Store removed inserts in a plastic bag or other sealable 
container until they can be disposed in accordance with applicable 
local, State, and Federal regulations.
    (2) This product is approved with the concurrent use of dinoprost 
solution on day 6 of the 7-day administration period. See Sec.  
522.690(c) of this chapter.
    (e) Conditions of use--(1) Amount. Administer one intravaginal 
insert per animal for 7 days. Administer 25 milligrams (mg) dinoprost (5 
milliliters (mL) of 5 mg/mL solution as in Sec.  522.690(a) of this 
chapter) 1 day prior to insert removal.
    (2) Indications for use. 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.
    (3) Limitations. Do not use in animals with abnormal, immature, or 
infected genital tracts; or in beef cows that are fewer than 20 days 
postpartum; or in beef or dairy heifers of insufficient size or age for 
breeding; or in lactating dairy cows. 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 solution as

[[Page 330]]

provided by No. 000009 in Sec.  510.600(c) of this chapter.

[67 FR 41824, June 20, 2002, as amended at 67 FR 51080, Aug. 7, 2002]



Sec.  529.2090  Salicylic acid.

    (a) Specifications. (1) Each dose contains 0.55 grain of salicylic 
acid in a gum arabic and dextrin vehicle.
    (2) Each dose is incorporated upon a device (teat dilator) suitable 
for insertion into and subsequent removal from the teat canal.
    (b) Sponsor. See No. 045087 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use. (1) The drug is used for the removal of scar 
tissue in the teat canal of milk-producing cows.
    (2) The labeling bears directions to the user to:
    (i) Treat lactating cows initially by inserting dosage and removal 
of the device;
    (ii) Insert second dose and permit device to remain in canal until 
the next milking; and
    (iii) Insert one dose following each milking for not more than 2 
days.
    (3) Milk that has been drawn from animals within 48 hours of such 
treatment may not be used for food.

[41 FR 10984, Mar. 15, 1976, as amended at 43 FR 29290, July 7, 1978; 55 
FR 29842, July 23, 1990; 55 FR 31481, Aug. 2, 1990; 62 FR 8372, Feb. 25, 
1997]



Sec.  529.2150  Sevoflurane.

    (a) Specifications. The drug is a clear, colorless, stable liquid 
containing no additives or chemical stabilizers.
    (b) Sponsor. See No. 000074 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use--(1) Amount. For induction of surgical 
anesthesia: 5 to 7 percent sevoflurane with oxygen. 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]



Sec.  529.2464  Ticarcillin powder.

    (a) Specifications. Each vial contains ticarcillin disodium 
equivalent to 6 grams of ticarcillin to be reconstituted with 25 
milliliters of sterile water for injection or sterile physiological 
saline.
    (b) Sponsor. See No. 000069 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use--(1) Amount. 6 grams per day, intrauterine, 
for 3 consecutive days during estrus.
    (2) Indications for use. Horses. Intrauterine treatment of 
endometritis caused by beta-hemolytic streptococci.
    (3) Limitations. For intrauterine use in horses only. Infuse 
aseptically. Not for use in horses raised for food production. 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 60 FR 55660, Nov. 2, 1995]



Sec.  529.2503  Tricaine methanesulfonate.

    (a) Chemical name. 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) It is used 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.
    (2) It is used as follows:
    (i) For 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) For 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.

[[Page 331]]

    (iii) 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 should exceed 10 [deg]C. 
(50 [deg]F.). In other fish and in cold-blooded animals, the drug should 
be limited to hatchery or laboratory use.

[40 FR 13881, Mar. 27, 1975, as amended at 49 FR 5748, Feb. 15, 1984; 51 
FR 11439, Apr. 3, 1986; 63 FR 7702, Feb. 17, 1998]



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 332]]

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 333]]

    (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 334]]

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 335]]

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 336]]

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 337]]

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.
    (b) The following drugs, families of drugs, and substances are 
prohibited for extralabel animal and human drug uses in nonfood-
producing animals: [Reserved]

[62 FR 27947, May 22, 1997, as amended at 67 FR 5471, Feb. 6, 2002]

    Effective Date Notes: 1. At 68 FR 9530, Feb. 28, 2003, Sec.  530.41 
was amended by adding paragraph (a)(12), effective May 29, 2003. For the 
convenience of the user, the added text is set forth as follows:

Sec.  530.41  Drugs prohibited for extralabel use in animals.

    (a) * * *
    (12) Phenylbutazone.

                                * * * * *

    2. At 68 FR 14134, Mar. 24, 2003, Sec.  530.41 was corrected on page 
9530, in the first column, in paragraph (a)(12), ``Phenylbutazone.'' was 
corrected to read ``Phenylbutazone in female dairy cattle 20 months of 
age or older.'', effective May 29, 2003.



PART 556--TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD--Table of Contents




                      Subpart A--General Provisions

Sec.
556.1 General considerations; tolerances for residues of new animal 
          drugs in food.

     Subpart B--Specific Tolerances for Residues of New Animal Drugs

556.20 2-Acetylamino-5-nitrothiazole.
556.30 Aklomide.
556.34 Albendazole.
556.38 Amoxicillin.
556.40 Ampicillin.
556.50 Amprolium.
556.52 Apramycin.
556.60 Arsenic.
556.70 Bacitracin.
556.90 Buquinolate.
556.100 Carbadox.
556.110 Carbomycin.
556.113 Ceftiofur.
556.115 Cephapirin.
556.120 Chlorhexidine.
556.140 Chlorobutanol.
556.150 Chlortetracycline.
556.160 Clopidol.
556.163 Clorsulon.
556.165 Cloxacillin.
556.167 Colistimethate.
556.169 Danofloxacin.
556.170 Decoquinate.
556.180 Dichlorvos.
556.185 Diclazuril.
556.200 Dihydrostreptomycin.
556.220 3,5-Dinitrobenzamide.
556.225 Doramectin.
556.227 Eprinomectin.
556.228 Enrofloxacin.
556.230 Erythromycin.
556.240 Estradiol and related esters.
556.260 Ethopabate.
556.270 Ethylenediamine.
556.273 Famphur.
556.275 Fenbendazole.
556.277 Fenprostalene.
556.283 Florfenicol.
556.286 Flunixin meglumine.
556.290 Furazolidone.
556.300 Gentamicin sulfate.
556.304 Gonadotropin.
556.308 Halofuginone hydrobromide.
556.310 Haloxon.
556.320 Hydrocortisone.
556.330 Hygromycin B.
556.344 Ivermectin.
556.347 Lasalocid.
556.350 Levamisole hydrochloride.
556.360 Lincomycin.
556.375 Maduramicin ammonium.
556.380 Melengestrol acetate.
556.390 Methylparaben.
556.400 Methylprednisolone.
556.410 Metoserpate hydrochloride.
556.420 Monensin.
556.425 Morantel tartrate.
556.426 Moxidectin.
556.428 Narasin.
556.430 Neomycin.
556.440 Nequinate.
556.445 Nicarbazin.
556.460 Novobiocin.
556.470 Nystatin.
556.480 Oleandomycin.
556.490 Ormetoprim.
556.495 Oxfendazole.
556.500 Oxytetracycline.
556.510 Penicillin.
556.513 Piperazine.
556.515 Pirlimycin.
556.520 Prednisolone.

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556.530 Prednisone.
556.540 Progesterone.
556.550 Propylparaben.
556.560 Pyrantel tartrate.
556.570 Ractopamine.
556.580 Robenidine hydrochloride.
556.590 Salicylic acid.
556.592 Salinomycin.
556.597 Semduramicin.
556.600 Spectinomycin.
556.610 Streptomycin.
556.620 Sulfabromomethazine sodium.
556.625 Sodium sulfachloropyrazine monohydrate.
556.630 Sulfachlorpyridazine.
556.640 Sulfadimethoxine.
556.650 Sulfaethoxypyridazine.
556.660 Sulfamerazine.
556.670 Sulfamethazine.
556.680 Sulfanitran.
556.685 Sulfaquinoxaline.
556.690 Sulfathiazole.
556.700 Sulfomyxin.
556.710 Testosterone propionate.
556.720 Tetracycline.
556.730 Thiabendazole.
556.735 Tilmicosin.
556.738 Tiamulin.
556.739 Trenbolone.
556.740 Tylosin.
556.741 Tripelennamine.
556.750 Virginiamycin.
556.760 Zeranol.
556.770 Zoalene.

    Authority: 21 U.S.C. 342, 360b, 371.

    Source: 40 FR 13942, Mar. 27, 1975, unless otherwise noted.



                      Subpart A--General Provisions



Sec.  556.1  General considerations; tolerances for residues of new animal drugs in food.

    (a) Tolerances established in this part are based upon residues of 
drugs in edible products of food-producing animals treated with such 
drugs. Consideration of an appropriate tolerance for a drug shall result 
in a conclusion either that:
    (1) Finite residues will be present in the edible products--in which 
case a finite tolerance is required; or
    (2) It is not possible to determine whether finite residues will be 
incurred but there is reasonable expectation that they may be present--
in which case a tolerance for negligible residue is required; or
    (3) The drug induces cancer when ingested by man or animal or, after 
tests which are appropriate for the evaluation of the safety of such 
drug, has been shown to induce cancer in man or animal; however, such 
drug will not adversely affect the animals for which it is intended, and 
no residue of such drug will be found by prescribed methods of analysis 
in any edible portion of such animals after slaughter or in any food 
yielded by or derived from the living animal--in which case the accepted 
method of analysis shall be published or cited, if previously published 
and available elsewhere, in this part; or
    (4) It may or may not be possible to determine whether finite 
residues will be incurred but there is no reasonable expectation that 
they may be present--in which case the establishment of a tolerance is 
not required; or
    (5) The drug is such that it may be metabolized and/or assimilated 
in such form that any possible residue would be indistinguishable from 
normal tissue constituents--in which case the establishment of a 
tolerance is not required.
    (b) No tolerance established pursuant to paragraph (a)(1) of this 
section will be set at any level higher than that reflected by the 
permitted use of the drug.
    (c) Any tolerance required pursuant to this section will, in 
addition to the toxicological considerations, be conditioned on the 
availability of a practicable analytical method to determine the 
quantity of residue. Such method must be sensitive to and reliable at 
the established tolerance level or, in certain instances, may be 
sensitive at a higher level where such level is also deemed satisfactory 
and safe in light of the toxicity of the drug residue and of the 
unlikelihood of such residue's exceeding the tolerance.



     Subpart B--Specific Tolerances for Residues of New Animal Drugs



Sec.  556.20  2-Acetylamino-5-nitrothiazole.

    A tolerance of 0.1 part per million is established for negligible 
residues of 2-acetylamino-5-nitrothiazole in the edible tissues of 
turkeys.



Sec.  556.30  Aklomide.

    Tolerances are established for combined residues of aklomide (2-
chloro-4-nitrobenzamide) and its metabolite (4-

[[Page 339]]

amino-2-chlorobenzamide) in uncooked edible tissues of chickens as 
follows:
    (a) 4.5 parts per million in liver and muscle.
    (b) 3 parts per million in skin with fat.



Sec.  556.34   Albendazole.

    (a) Acceptable daily intake (ADI). The ADI for total residues of 
albendazole is 5 micrograms per kilogram of body weight per day.
    (b) Tolerances--(1) Cattle. A tolerance is established for 
albendazole 2-aminosulfone (marker residue) in liver (target tissue) of 
0.2 part per million and in muscle of 0.05 part per million.
    (2) Sheep. A tolerance is established for albendazole 2-aminosulfone 
(marker residue) in liver (target tissue) of 0.25 part per million and 
in muscle of 0.05 part per million.

[64 FR 1504, Jan. 11, 1999]



Sec.  556.38  Amoxicillin.

    A tolerance of 0.01 part per million is established for negligible 
residues of amoxicillin in milk and in the uncooked edible tissues of 
cattle.

[49 FR 45422, Nov. 16, 1984]



Sec.  556.40  Ampicillin.

    A tolerance of 0.01 p/m is established for negligible residues of 
ampicillin in the uncooked edible tissues of swine and cattle and in 
milk.



Sec.  556.50  Amprolium.

    Tolerances are established as follows for residues of amprolium (1-
(4-amino-2-n- propyl-5-pyrimidinylmethyl)-2-picolinium chloride 
hydrochloride):
    (a) In the edible tissues and in eggs of chickens and turkeys:
    (1) 1 part per million in uncooked liver and kidney.
    (2) 0.5 part per million in uncooked muscle tissue.
    (3) In eggs:
    (i) 8 parts per million in egg yolks.
    (ii) 4 parts per million in whole eggs.
    (b) In the edible tissues of calves:
    (1) 2.0 parts per million in uncooked fat.
    (2) 0.5 part per million in uncooked muscle tissue, liver, and 
kidney.
    (c) In the edible tissues of pheasants:
    (1) 1 part per million in uncooked liver.
    (2) 0.5 part per million in uncooked muscle.

[40 FR 13942, Mar. 27, 1975, as amended at 50 FR 18472, May 1, 1985]



Sec.  556.52  Apramycin.

    A tolerance of 0.1 part per million is established for parent 
apramycin (marker residue) in kidney (target tissue) of swine. The 
acceptable daily intake (ADI) for total residues of apramycin is 25 
micrograms per kilogram of body weight per day.

[62 FR 40933, July 31, 1997]



Sec.  556.60  Arsenic.

    Tolerances for total residues of combined arsenic (calculated as As) 
in food are established as follows:
    (a) In edible tissues and in eggs of chickens and turkeys:
    (1) 0.5 part per million in uncooked muscle tissue.
    (2) 2 parts per million in uncooked edible by-products.
    (3) 0.5 part per million in eggs.
    (b) In edible tissues of swine:
    (1) 2 parts per million in uncooked liver and kidney.
    (2) 0.5 part per million in uncooked muscle tissue and by-products 
other than liver and kidney.



Sec.  556.70  Bacitracin.

    (a) Acceptable daily intake (ADI). The ADI for total residues of 
bacitracin is 0.05 milligram per kilogram of body weight per day.
    (b) Tolerances. The tolerance for residues of bacitracin from zinc 
bacitracin or bacitracin methylene disalicylate in uncooked edible 
tissues of cattle, swine, chickens, turkeys, pheasants, and quail, and 
in milk and eggs is 0.5 part per million.

[65 FR 70791, Nov. 28, 2000]



Sec.  556.90  Buquinolate.

    Tolerances are established for residues of buquinolate as follows:
    (a) In edible tissues of chickens:
    (1) 0.4 part per million in uncooked liver, kidney, and skin with 
fat.
    (2) 0.1 part per million in uncooked muscle.
    (b) In eggs:

[[Page 340]]

    (1) 0.5 part per million in uncooked yolk.
    (2) 0.2 part per million in uncooked whole eggs.



Sec.  556.100  Carbadox.

    A tolerance of 30 parts per billion is established for residues of 
quinoxaline-2-carboxylic acid (marker residue) in liver (target tissue) 
of swine.

[63 FR 13337, Mar. 19, 1998]



Sec.  556.110  Carbomycin.

    A tolerance of zero is established for residues of carbomycin in the 
uncooked edible tissues of chickens.



Sec.  556.113   Ceftiofur.

    (a) Acceptable daily intake (ADI). The ADI for total residues of 
ceftiofur is 30 micrograms per kilogram of body weight per day.
    (b) Tolerances--(1) Swine, poultry, and sheep. A tolerance for 
residues of ceftiofur in edible tissue is not required.
    (2) Cattle. Tolerances are established for residues of 
desfuroylceftiofur (marker residue) in edible cattle tissues at 8 parts 
per million in kidney (target tissue), 2 parts per million in the liver, 
1 part per million in muscle, and 100 parts per billion in milk.

[63 FR 53579, Oct. 6, 1998]



Sec.  556.115  Cephapirin.

    A tolerance of 0.02 parts per million (ppm) is established for 
residues of cephapirin in the milk and 0.1 ppm in the uncooked edible 
tissues of dairy cattle.

[40 FR 57454, Dec. 10, 1975]



Sec.  556.120  Chlorhexidine.

    A tolerance of zero is established for residues of chlorhexidine in 
the uncooked edible tissues of calves.



Sec.  556.140  Chlorobutanol.

    A tolerance of zero is established for residues of chlorobutanol in 
milk from dairy animals.



Sec.  556.150  Chlortetracycline.

    (a) Acceptable daily intake (ADI). The ADI for total residues of 
tetracyclines including chlortetracycline, oxytetracycline, and 
tetracycline is 25 micrograms per kilogram of body weight per day.
    (b) Tolerances. (1) Tolerances are established for the sum of 
tetracycline residues in tissues of beef cattle, nonlactating dairy 
cows, calves, swine, sheep, chickens, turkeys, and ducks, of 2 parts per 
million (ppm) in muscle, 6 ppm in liver, and 12 ppm in fat and kidney.
    (2) A tolerance is established for residues of chlortetracycline in 
eggs of 0.4 ppm.

[63 FR 52158, Sept. 30, 1998, as amended at 63 FR 57246, Oct. 27, 1998]



Sec.  556.160  Clopidol.

    Tolerances for residues of clopidol (3,5-dichloro-2,6-dimethyl-4-
pyridinol) in food are established as follows:
    (a) In cereal grains, vegetables, and fruits: 0.2 part per million.
    (b) In chickens and turkeys:
    (1) 15 parts per million in uncooked liver and kidney.
    (2) 5 parts per million in uncooked muscle.
    (c) In cattle, sheep, and goats:
    (1) 3 parts per million in uncooked kidney.
    (2) 1.5 parts per million in uncooked liver.
    (3) 0.2 part per million in uncooked muscle.
    (d) In swine: 0.2 part per million in uncooked edible tissues.
    (e) In milk: 0.02 part per million (negligible residue).



Sec.  556.163  Clorsulon.

    (a) Acceptable daily intake (ADI). The ADI for total residues of 
clorsulon is 8 micrograms per kilogram of body weight per day.
    (b) Tolerances--(1) Cattle--(i) Kidney (the target tissue). The 
tolerance for parent clorsulon (the marker residue) is 1.0 part per 
million.
    (ii) Muscle. The tolerance for parent clorsulon (the marker residue) 
is 0.1 part per million.
    (2) [Reserved]

[66 FR 35544, July 6, 2001]



Sec.  556.165  Cloxacillin.

    A tolerance of 0.01 part per million is established for negligible 
residues of

[[Page 341]]

cloxacillin in the uncooked edible tissues of cattle and in milk.

[40 FR 28792, July 9, 1975]



Sec.  556.167  Colistimethate.

    A tolerance for residues of colistimethate in the edible tissues of 
chickens is not required.

[63 FR 13123, Mar. 18, 1998]



Sec.  556.169  Danofloxacin.

    (a) Acceptable daily intake (ADI). The ADI for total residues of 
danofloxacin is 2.4 micrograms per kilogram of body weight per day.
    (b) Tolerances--(1) Cattle--(i) Liver (the target tissue). The 
tolerance for parent danofloxacin (the marker residue) is 0.2 part per 
million (ppm).
    (ii) Muscle. The tolerance for parent danofloxacin (the marker 
residue) is 0.2 ppm.
    (2) [Reserved]

[67 FR 78973, Dec. 27, 2002]



Sec.  556.170  Decoquinate.

    (a) Acceptable daily intake (ADI). The ADI for total residues of 
decoquinate is 75 micrograms per kilogram of body weight per day.
    (b) Tolerances. Tolerances are established for residues of 
decoquinate in the uncooked, edible tissues of chickens, cattle, and 
goats as follows:
    (1) 1 part per million (ppm) in skeletal muscle.
    (2) 2 ppm in other tissues.

[64 FR 10103, Mar. 2, 1999]



Sec.  556.180  Dichlorvos.

    A tolerance of 0.1 part per million is established for negligible 
residues of dichlorvos (2,2-dichlorovinyl dimethyl phosphate) in the 
edible tissues of swine.



Sec.  556.185  Diclazuril.

    (a) Acceptable daily intake (ADI). The ADI for total residues of 
diclazuril is 25 micrograms per kilogram of body weight per day.
    (b) Tolerances--(1) Chickens--(i) Liver. The tolerance for parent 
diclazuril (the marker residue) is 3 parts per million (ppm).
    (ii) Muscle. The tolerance for parent diclazuril (the marker 
residue) is 0.5 ppm.
    (iii) Skin/fat. The tolerance for parent diclazuril (the marker 
residue) is 1 ppm.
    (2) Turkeys--(i) Liver. The tolerance for parent diclazuril (the 
marker residue) is 3 ppm.
    (ii) Muscle. The tolerance for parent diclazuril (the marker 
residue) is 0.5 ppm.
    (iii) Skin/fat. The tolerance for parent diclazuril (the marker 
residue) is 1 ppm.

[64 FR 35923, July 2, 1999. Redesignated and amended at 66 FR 62917, 
Dec. 4, 2001]



Sec.  556.200  Dihydrostreptomycin.

    Tolerances are established for residues of dihydrostreptomycin in 
uncooked, edible tissues of cattle and swine of 2.0 parts per million 
(ppm) in kidney and 0.5 ppm in other tissues, and 0.125 ppm in milk.

[59 FR 41977, Aug. 16, 1994]



Sec.  556.220  3,5-Dinitrobenzamide.

    No residues of 3,5-dinitrobenzamide may be found in the uncooked 
edible tissues of chickens as determined by the following method of 
analysis:

    I. Method of analysis--3,5-dinitrobenzamide. A method for 3,5-
dinitrobenzamide (3,5-DNBA) in chicken tissues is described with a 
cleanup step that removes most of the interfering materials, thus 
allowing uncompensated measurements to be read. The 3,5-DNBA is 
extracted from the sample with acetone and chloroform and prepared for 
chromatography by removing the aqueous phase in a separatory funnel and 
the solvents in a flash evaporator. The extract residue is 
chromatographed on alumina to remove several lipid components and 
residues of other drugs. The benzamide eluate is passed through a column 
of Dowex-50 resin, or equivalent, to remove arylamines; for example, 3-
amino-5-nitrobenzamide. The 3,5-DNBA fraction is reduced, after removal 
of alcohol, with TiCl3 in basic solution to an arylamine, 
presumably 3,5-diaminobenzamide. The reduced fraction is placed on 
another Dowex-50 column, most of the interfering substances are removed 
with washings of alcohol and water, and the arylamine residue is eluted 
with 4N HCl. Colorimetric measurement is made in a 100-millimeter cell 
at 530 millimicrons after reacting the residue with Bratton-Marshall 
reagents.
    II. Reagents. A. Acetone.

[[Page 342]]

    B. Acetyl-(p- nitrophenyl)-sulfanilamide (APNPS) standard--melting 
point range 264 [deg]C.-267 [deg]C. Weigh and transfer 10 milligrams of 
APNPS to a 100-milliliter flask, dissolve and dilute to volume with 
acetone.
    C. Alumina--activated F-20, 80-200 mesh, Aluminum Co. of America, or 
equivalent substance.
    D. Ammonium sulfamate.
    E. Ammonium sulfamate solution 1.25 grams of ammonium sulfamate per 
100 milliliters of water. Refrigerate when not in use. Prepare fresh 
weekly.
    F. Cation-exchange resin--Dowex 50W-X8, 200-400 mesh, Baker Analyzed 
Reagent, or equivalent, prepared as follows:
    1. Place 500 grams of resin into a 3-liter beaker.
    2. Add 2,000 milligrams of 6N HCl.
    3. Heat and stir while on a bath at 80 [deg]C. for 6 hours. 
Discontinue heating and continue stirring overnight.
    4. Filter the resin on a Buchner funnel (24 cm.) fitted with Whatman 
No. 1 paper.
    5. Wash the resin bed with four 500-milliliter portions of 6N HCl.
    6. Wash the resin bed with 500-milliliter portions of deionized 
water until the effluent has a pH of 5 or higher.
    7. Wash the resin bed with three 400-milliliter portions of 
specially denatured alcohol 3A. Drain thoroughly.
    8. Make a slurry of resin in 1,250 milliliters of specially 
denatured alcohol 3A.
    G. Chloroform.
    H. Coupling reagent--0.25 gram of N-1-naphthyl-ethylenediamine 
dihydrochloride per 100 milliliters of water. Refrigerate when not in 
use. Prepare fresh weekly.
    I. 3,5-Dinitrobenzamide (3,5-DNBA standard). Add to boiling 
specially denatured alcohol 3A until a saturated solution is obtained 
and treat with activated carbon, filtered and crystallize by cooling to 
room temperature. The 3,5-DNBA therefrom is treated a second time with 
activated carbon and then recrystallized three more times from specially 
denatured alcohol 3A. The third crystallization is washed with diethyl 
ether and dried in a vacuum desiccator, melting point range 185 [deg]C.-
186 [deg]C.
    J. Ethyl alcohol--absolute, A.C.S.
    K. Eluting reagent A. The formula and volume required in procedure 
step V-D is dependent on the adsorptive strength of the Al2 
O3. For each lot Al2 O3, make the 
following test:
    1. Prepare a column (see procedure step V-D for determining formula 
and volume to eluting reagent A).
    2. Transfer 1 milliliter of APNPS standard (100 micrograms per 
milliliter) in 75 milliliters of chloroform to the column.
    3. Wash the column with 100 milliliters of chloroform and discard 
the eluate.
    4. Pass through 100 milliliters of solution consisting of specially 
denatured alcohol 3A and ethyl alcohol 1:1 (volume to volume). Collect 
one 50-milliliter and five 10-milliliter portions; these make up the 
first, second, third, fourth, fifth, and sixth portions of eluate.
    5. Place in beakers under a stream of air on a water bath (90 
[deg]C.) until the solvents are evaporated.
    6. Add 10 milliliters of 4N HCl to each, cover with watch glasses 
and heat (90 [deg]C.) for 30 minutes; cool to room temperature.
    7. Add the Bratton-Marshall reagents.
    8. All fractions show a slight color. Note the portion containing 
the first significant increase in pink color.
    a. If the color increases in the second, third, or fourth portions 
of eluate, the formula in procedure step V-D is suitable and, depending 
on the portion, 45, 55, or 65 milliliters, respectively, should be used 
in procedure step V-D4. Thereby, the APNPS is retained on the column and 
the benzamides are eluted.
    b. If the color increases in the first portion, the eluting strength 
of the reagent is too strong. Return the test, substituting 1:4 (volume 
to volume) in procedure step V-D4. If 1:4 (volume to volume) is too 
strong, rerun with ethyl alcohol in procedure step V-D. If none of these 
are suitable, another lot of Al2 O3 should be 
used.
    c. If the color increases in the fifth or sixth portion, the eluting 
strength of the reagent is too weak. Rerun the test, substituting in 
procedure step V-D4, respectively, 4:1 (volume to volume), specially 
denatured alcohol 3A: methyl alcohol, 4:1 (volume to volume), until a 
suitable formula is found. If none of these are suitable, another lot of 
Al2 O3 should be used.
    L. Hydrochloric acid, 4N. Add two volumes of water to one volume of 
HCl.
    M. Diatomaceous earth--Hyflo Super Cel, Johns-Manville Co., or 
equivalent substance.
    N. N-1-Naphthylethylenediamine dihydrochloride.
    O. Sodium hydroxide solution, 10N. Dissolve 100 grams of sodium 
hydroxide in water and dilute to 25 milliliters.
    P. Sodium nitrite solution--0.25 grams of sodium nitrite per 100 
milliliters of water. Refrigerate when not in use. Prepare fresh weekly.
    Q. Specially denatured alcohol, formula 3A-100 parts of 190-proof 
ethyl alcohol plus 5 parts of commercial methyl alcohol.
    R. Titanium(ous) chloride-20 percent solution.
    III. Special apparatus. A. Absorption cells--Beckman No. 75195 
matched set of two cylindrical silica cells with 100 millimeter optical 
length, or equivalent cells.
    B. Autotransformer--type 500B, or equivalent. To regulate speed of 
mixer.
    C. Centrifuge.
    D. Centrifuge tubes--50-milliliter size with glass stopper.

[[Page 343]]

    E. Chromatography tubes--Corning No. 38460, 20 millimeters A 400 
millimeters and having a tapered 29/42 joint with coarse, fritted disc, 
or equivalent tubes.
    F. Evaporator--vacuum, rotary, thin film.
    G. Ion-exchange column--as described by Thiegs et al. in 
``Determination of 3-amino-5-nitro-o-toluamide (ANOT) in chicken 
tissues'' published in ``Journal of Agricultural and Food Chemistry,'' 
volume 9, pages 201-204 (1961).
    H. Glycerol manostat. For regulating pressure on columns: To 
Al2 O3 columns, 15-inch head pressure; to ion-
exchange columns, 30-inch head pressure.
    I. Motor speed control. For regulating speed on 1-quart blender.
    J. Volumetric flasks--50 milliliter size, actinic ware.
    K. Mixer--Vortex Jr. Model K-500-1, Scientific Industries, Inc., or 
equivalent mixer.
    L. One-quart blender.
    M. Water bath (45 [deg]C.-50[deg] C.).
    N. Water bath (90 [deg]C.).
    IV. Standard curve. A. 1. Weigh 100 milligrams of 3,5-DNBA and 
transfer to a 1-liter volumetric flask with acetone.
    2. Dissolve and dilute with acetone to volume.
    3. Dilute 1 milliliter to 100 milliliters.
    4. Add 5.0 milliliters of water to each of six centrifuge tubes.
    5. Add standard to each of the tubes to contain one of the following 
amounts: 0.0, 1.0, 2.0, 3.0, 5.0, and 10.0 micrograms of 3,5-DNBA.
    B. Prepare each tube for colorimetric measurement as follows:
    1. Place the tube in a hot water bath (90 [deg]C.) until 5.0 
milliliters remain. Cool to room temperature.
    2. While mixing on Vortex mixer, or equivalent, regulated with an 
autotransformer, add 2 drops of TiCl3 and 4 drops of 10N 
NaOH. Continue mixing until chalky-white in appearance.
    3. Add 2 milliliters of HCl, mix, and allow to stand for 5 minutes.
    4. Transfer to 50-milliliter volumetric flask and dilute with 4N HCl 
to 40-45 milliliters.
    5. Cool to 0 [deg]C.-5 [deg]C. by placing in a freezer or ice bath.
    6. Perform the Bratton-Marshall reaction in subdued light as 
follows:
    a. Add 1 milliliter of sodium nitrite reagent, mix, and allow to 
stand for 1 minute.
    b. Add 1 milliliter of ammonium sufamate reagent, mix, and allow to 
stand for 1 minute.
    c. Add 1 milliliter of coupling reagent, mix, and allow to stand for 
10 minutes.
    d. Dilute to volume with 4N HCl.
    C. Perform colorimetric measurement at 530 millimicrons as follows:
    1. Fill two matched 100-millimeter cells with 4N HCl and place into 
spectrophotometer.
    2. Adjust dark current.
    3. Adjust to zero absorbance.
    4. Replace acid in cell of sample side of compartment with standard 
to be measured.
    5. The standard curve should be run five different times. Plot 
equivalent concentration in tissue versus mean absorbance at each 
concentration. If computer is available, a better procedure is to 
calculate the equation of the standard curve by means of least squares.
    V. Procedure. A. Extraction. 1. Mince 350 grams of tissue in a 1-
quart blending jar for 3 minutes. Use samples obtained from either 
freshly killed or quickly frozen birds. The latter should be analyzed as 
soon as thawed. For fibrous meats (for example, muscle, skin) put 
through a meat grinder before mincing.
    2. Weight 100 +/-0.5 grams of each replicate sample in a 150-
milliliter beaker. Analyze each sample in triplicate and average the 
results. Reproducibility of +/-10 percent between such analyses has been 
obtained.
    3. Transfer the sample to a 1-quart blender jar. For kidney and 
liver tissues, make a slurry with acetone in the weighing beaker. 
Transfer with several rinses of acetone.
    4. Blend the sample for 5 minutes with 250 milliliters of acetone 
and a 100-milliliter beakerful of diatomaceous earth.
    5. Filter through a Buchner funnel containing a wetted Whatman No. 5 
filter paper (12.5 cm.) into a 1-liter suction flask.
    6. Rinse the blender jar into the funnel with three 25-milliliter 
portions of acetone.
    7. Transfer the pulp and paper from the funnel to the aforementioned 
blender jar.
    8. Add 250 milliliters of chloroform.
    9. Blend for 3 minutes.
    10. Filter through the aforementioned apparatus of procedure step V-
A5. For rapid filtration of skin and blood samples, prepare funnel by 
adding diatomaceous earth and tamping evenly over paper to a thickness 
of 3 to 5 millimeters.
    11. Rinse the blender jar into the funnel with three 25-milliliter 
rinses of chloroform.
    B. Phasic separation. 1. Pour the combined filtrates into a 1-liter 
separatory funnel.
    2. Rinse the suction flask twice with 25 milliliters of chloroform.
    3. Mix the funnel contents by gently rocking and swirling for 30 
seconds.
    4. Let stand 10 minutes to allow phases to separate.
    a. The upper (aqueous) phase (30 to 50 milliliters) is not always 
emulsion-free. Losses from emulsions have not been significant.
    b. If an upper (aqueous) phase does not appear, add an additional 
100 milliliters of chloroform and 10 milliliters of water and repeat 
procedure step V-B3.
    5. Withdraw the lower phase into a 1-liter round-bottom flask, and 
discard upper phase. Withdraw nearly all of the lower phase, let stand 
for 2 to 3 minutes, then withdraw the remainder.

[[Page 344]]

    C. Evaporation. Attach the flask on a thin-film rotary evaporator 
connected to a vacuum supply, and place in a water bath maintained at 45 
[deg]C.-50 [deg]C. until an oily residue remains. Do not overheat the 
sample or allow to go to dryness.
    D. Adsorption chromatography. 1. Prepare a chromatography column 
using a column with calibrated etchings to indicate appropriate 
adsorbent and solvent levels as follows:
    a. Fill tube to a depth of 60 millimeters with 
Al2O3.
    b. Tap walls gently with hands.
    c. Add anhydrous sodium sulfate to an additional depth of 25 
millimeters.
    d. Wet and wash column with 50 milliliters of chloroform.
    i. During chromatography, make each addition to the tube when the 
liquid level has reached the top of the sodium sulfate layer.
    ii. Increase the percolation rates by applying a slight air pressure 
to the top of the column.
    2. Transfer the residue from procedure step V-C to the column with 
four 15-milliliter rinses of chloroform. Then rinse the walls of the 
tube and sodium sulfate layer with three 5-milliliter portions of 
chloroform. Percolation rate: 15 to 25 milliliters per minute. No color 
from sample should be seen in sodium sulfate layer after final rinse.
    3. Wash column with 100 milliliters of chloroform. Discard eluate.
    4. Add 75 milliliters of eluting reagent A and collect eluate A in a 
250-milliliter beaker for cation-exchange chromatography.
    a. Refer to ``Eluting reagent A'' under ``Reagents'' (II-K) for 
determining formula and volume.
    b. Percolation rate: 8 to 12 milliliters per minute.
    E. Cation-exchange chromatography--No. 1. 1. Prepare an ion-exchange 
column as follows:
    a. Add a uniform slurry of resin to the column to obtain a 4 to 5 
centimeter bed depth after settling.
    i. Obtain a uniform slurry using a magnetic stirrer. To add the 
required amount of resin, calibrate the slurry and transfer it with a 
10-milliliter pipette to deliver a reproducible volume.
    ii. Increase the flow rate to 2 to 4 milliliters per minute by 
applying air pressure to the column. A glycerol manostat adjusted to 30 
inches and attached between an air supply and column provides adequate 
pressure.
    b. Wash the resin with 10 milliliters of eluting reagent A. Discard 
eluate.
    2. Pass eluate A from procedure step V-D4 through the column. 
Collect in a 250-milliliter beaker.
    3. Pass 50 milliliters of specially denatured alcohol 3A through the 
column. Combine with the eluate of procedure step V-E2.
    F. Reduction. 1. Place the eluate A fraction from procedure step V-
E3 on a hot water bath (90 [deg]C.) and evaporate with a stream of air 
until 5 to 10 milliliters remain. Do not overheat the sample or allow 
the sample to go to dryness.
    2. Transfer to centrifuge tube and rinse beaker three times with 3 
milliliters of specially denatured alcohol 3A.
    3. Evaporate on a hot water bath (90 [deg]C.) under a stream of air 
until alcohol has evaporated. Do not overheat the sample or allow the 
sample to go to dryness.
    4. Remove the tube from the water bath and immediately add 5.0 
milliliters of water.
    5. While mixing, add 2 drops of titanium chloride and 4 drops of 10N 
sodium hydroxide. Continue mixing until greyish color disappears.
    a. Mix on Vortex Jr. mixer, or equivalent, regulated with 
autotransformer.
    b. Precipitate of insoluble tissue substances and white titanium 
salts is present after reduction is complete.
    6. Dilute to 50 milliliters with specially denatured alcohol 3A and 
mix.
    7. Centrifuge for 5 minutes at 2,000 r.p.m.
    G. Cation-exchange chromatography--No. 2. 1. Prepare resin column by 
procedure step V-E.
    2. Pass the centrifugate of procedure step V-F7 through column. Use 
three rinses of specially denatured alcohol 3A, each 5 milliliters, to 
aid in transferring of sample.
    3. Pass 50 milliliters of specially denatured alcohol 3A through the 
column.
    4. Pass 50 milliliters of deionized water through the column.
    5. Elute arylamine residue from the resin with 40 to 43 milliliters 
of 4N HCl into a 50-milliliter volumetric flask (actinic ware) for 3,5-
DNBA analysis. Avoid direct sunlight. The arylamine has been found to be 
photosensitive.
    H. Color development and measurement. 1. Cool to 0 [deg]C.-5 [deg]C. 
by placing in a freezer or ice bath.
    2. Perform the Bratton-Marshall reaction in subdued light as 
follows:
    a. Add 1 milliliter of sodium nitrite reagent, mix, and allow to 
stand for 1 minute.
    b. Add 1 milliliter of ammonium sulfamate reagent, mix, and allow to 
stand for 1 minute.
    c. Add 1 milliliter of coupling reagent, mix, and allow to stand for 
10 minutes.
    d. Dilute to volume with 4N HCl.
    3. Perform colorimetric measurement at 530 millimicrons as follows:
    a. Fill two matched 100-millimeter cells with 4N HCl and place into 
instrument.
    b. Adjust dark current.
    c. Adjust to zero absorbance.
    d. Replace acid in cell of sample side of compartment with sample to 
be measured.
    e. Record absorbance observed.

[[Page 345]]

    I. Calculations. Determine parts per billion (observed) from the 
standard curve.



Sec.  556.225  Doramectin.

    (a) Acceptable daily intake (ADI). The ADI for total residues of 
doramectin is 0.75 microgram per kilogram of body weight per day.
    (b) Tolerances--(1) Cattle. A tolerance of 100 parts per billion is 
established for parent doramectin (marker residue) in liver (target 
tissue) and of 30 parts per billion for parent doramectin in muscle.
    (2) Swine. A tolerance is established for parent doramectin (marker 
residue) in liver (target tissue) of 160 parts per billion.

[63 FR 68184, Dec. 10, 1998]



Sec.  556.227  Eprinomectin.

    (a) Acceptable daily intake (ADI). The ADI for total residues of 
eprinomectin is 10 micrograms per kilogram of body weight per day.
    (b) Tolerances--(1) Cattle. Tolerances are established for residues 
of eprinomectin B1a (marker residue) in milk of 12 parts per billion, in 
liver (target tissue) of 4.8 parts per million, and in muscle of 100 
parts per billion.
    (2) [Reserved]

[63 FR 59715, Nov. 5, 1998]



Sec.  556.228  Enrofloxacin.

    The acceptable daily intake for enrofloxacin is 3 micrograms per 
kilogram of body weight per day.
    (a) Chickens and turkeys. A tolerance of 0.3 part per million is 
established for residues of enrofloxacin (marker residue) in muscle 
(target tissue) of chickens and turkeys.
    (b) Cattle. A tolerance of 0.1 part per million for desethylene 
ciprofloxacin (marker residue) has been established in liver (target 
tissue) of cattle.

[61 FR 56893, Nov. 5, 1996, as amended at 63 FR 49003, Sept. 14, 1998]



Sec.  556.230  Erythromycin.

    Tolerances for residues of erythromycin in food are established as 
follows:
    (a) 0.1 part per million in uncooked edible tissues of beef cattle 
and swine.
    (b) Zero in milk.
    (c) 0.025 part per million in uncooked eggs.
    (d) 0.125 part per million (negligible residue) in uncooked edible 
tissues of chickens and turkeys.

[40 FR 13942, Mar. 27, 1975, as amended at 58 FR 43795, Aug. 18, 1993]



Sec.  556.240  Estradiol and related esters.

    No residues of estradiol, resulting from the use of estradiol or any 
of the related esters, are permitted in excess of the following 
increments above the concentrations of estradiol naturally present in 
untreated animals:
    (a) In uncooked edible tissues of heifers, steers, and calves:
    (1) 120 parts per trillion for muscle.
    (2) 480 parts per trillion for fat.
    (3) 360 parts per trillion for kidney.
    (4) 240 parts per trillion for liver.
    (b) In uncooked edible tissues of lambs:
    (1) 120 parts per trillion for muscle.
    (2) 600 parts per trillion for fat, kidney, and liver.

[49 FR 13873, Apr. 9, 1984, as amended at 56 FR 67175, Dec. 30, 1991]



Sec.  556.260  Ethopabate.

    Tolerance for residues of ethopabate converted to metaphenetidine 
are established in the edible tissues of chickens as follows:
    (a) 1.5 parts per million in uncooked liver and kidney.
    (b) 0.5 part per million in uncooked muscle.



Sec.  556.270  Ethylenediamine.

    A tolerance of zero is established for residues of ethylenediamine 
in milk.



Sec.  556.273  Famphur.

    Tolerances are established for residues of famphur including its 
oxygen analog in or on meat, fat, or meat byproducts of cattle at 0.1 
part per million.

[62 FR 55161, Oct. 23, 1997]



Sec.  556.275  Fenbendazole.

    (a) Acceptable daily intake (ADI). The ADI for total residues of 
fenbendazole is 40 micrograms per kilogram of body weight per day.

[[Page 346]]

    (b) Tolerances--(1) Cattle--(i) Liver (the target tissue). The 
tolerance for parent fenbendazole (the marker residue) is 0.8 part per 
million (ppm).
    (ii) Muscle. The tolerance for parent fenbendazole (the marker 
residue) is 0.4 ppm.
    (iii) Milk. The tolerance for fenbendazole sulfoxide metabolite (the 
marker residue in cattle milk) is 0.6 ppm.
    (2) Swine--(i) Liver (the target tissue). The tolerance for parent 
fenbendazole (the marker residue) is 6 ppm.
    (ii) Muscle. The tolerance for parent fenbendazole (the marker 
residue) is 2 ppm.
    (3) Turkeys--(i) Liver (the target tissue). The tolerance for 
fenbendazole sulfone (the marker residue) is 6 ppm.
    (ii) Muscle. The tolerance for fenbendazole sulfone (the marker 
residue) is 2 ppm.
    (4) Goats--(i) Liver (the target tissue). The tolerance for parent 
fenbendazole (the marker residue) is 0.8 ppm.
    (ii) Muscle. The tolerance for parent fenbendazole (the marker 
residue) is 0.4 ppm.

[65 FR 20733, Apr. 18, 2000, as amended at 65 FR 41588, July 6, 2000; 65 
FR 50914, Aug. 22, 2000]



Sec.  556.277  Fenprostalene.

    A tolerance for marker residue of fenprostalene in cattle is not 
needed. The safe concentrations for the total residues of fenprostalene 
in the uncooked edible tissues of cattle are 10 parts per billion in 
muscle, 20 parts per billion in liver, 30 parts per billion in kidney, 
40 parts per billion in fat, and 100 parts per billion in the injection 
site. As used in this section ``tolerance'' refers to a concentration of 
a marker residue in the target tissue selected to monitor for total 
residues of the drug in the target animal, and ``safe concentrations'' 
refer to the concentrations of total residues considered safe in edible 
tissues.

[49 FR 26716, June 29, 1984]



Sec.  556.283  Florfenicol.

    (a) Acceptable daily intake (ADI). The ADI for total residues of 
florfenicol is 10 micrograms per kilogram of body weight per day.
    (b) Tolerances--(1) Cattle--(i) Liver (the target tissue). The 
tolerance for florfenicol amine (the marker residue) is 3.7 parts per 
million (ppm).
    (ii) Muscle. The tolerance for florfenicol amine (the marker 
residue) is 0.3 ppm.
    (2) Swine--(i) Liver (the target tissue). The tolerance for parent 
florfenicol (the marker residue) is 2.5 ppm.
    (ii) Muscle. The tolerance for parent florfenicol (the marker 
residue) is 0.2 ppm.

[63 FR 41191, Aug. 3, 1998, as amended at 67 FR 78357, Dec. 24, 2002]



Sec.  556.286  Flunixin meglumine.

    (a) Acceptable daily intake (ADI). The ADI for total residues of 
flunixin is 0.72 micrograms per kilogram of body weight per day.
    (b) Tolerances. For residues of parent flunixin free acid of 0.125 
part per million (ppm) in cattle liver (target tissue) and 0.025 ppm in 
cattle muscle are established.

[63 FR 38750, July 20, 1998]



Sec.  556.290  Furazolidone.

    A tolerance of zero is established for residues of furazolidone in 
the uncooked edible tissues of swine.



Sec.  556.300  Gentamicin sulfate.

    (a) A tolerance of 0.1 part per million is established for 
negligible residues of gentamicin sulfate in the uncooked edible tissues 
of chickens and turkeys.
    (b) Tolerances are established for total residues of gentamicin in 
edible tissues of swine as follows: 0.1 part per million in muscle, 0.3 
part per million in liver, and 0.4 part per million in fat and kidney. A 
microbiological determinative procedure and an HPLC confirmatory 
procedure for gentamicin have been developed to assay gentamicin in 
kidney at 0.4 ppm. Since residues of gentamicin as the parent compound 
and total residues are equal, the marker (parent drug) residue 
concentration of 0.4 ppm in kidney corresponds to 0.4 ppm of total 
residue.

[48 FR 791, Jan. 7, 1983, as amended at 61 FR 24441, May 15, 1996]

[[Page 347]]



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 I.U. per kilogram of body weight per day.
    (b) Tolerances. A tolerance for residues of gonadotropin in uncooked 
edible tissues of cattle or of fish is not required.

[64 FR 48545, Sept. 7, 1999]



Sec.  556.308  Halofuginone hydrobromide.

    The marker residue selected to monitor for total residues of 
halofuginone hydrobromide in broilers and turkeys is parent halofuginone 
hydrobromide and the target tissue selected is liver. A tolerance is 
established in broilers of 0.16 part per million and in turkeys of 0.13 
part per million for parent halofuginone hydrobromide in liver. These 
marker residue concentrations in liver correspond to total residue 
concentrations of 0.3 part per million in liver. The safe concentrations 
for total residues of halofuginone hydrobromide in the uncooked edible 
tissues of broilers and turkeys are 0.1 part per million in muscle, 0.3 
part per million in liver, and 0.2 part per million in skin with 
adhering fat. As used in this section, ``tolerance'' refers to a 
concentration of a marker residue in the target tissue selected to 
monitor for total residues of the drug in the target animal, and ``safe 
concentrations'' refers to the concentrations of total residues 
considered safe in edible tissues.

[54 FR 28052, July 5, 1989, as amended at 56 FR 8711, Mar. 1, 1991; 57 
FR 21209, May 19, 1992]



Sec.  556.310  Haloxon.

    A tolerance of 0.1 part per million is established for negligible 
residues of haloxon (3-chloro-7-hydroxy-4-methyl-coumarin bis(2-
chloroethyl) phosphate) in the edible tissues of cattle.

[40 FR 13942, Mar. 27, 1975, as amended at 45 FR 10333, Feb. 15, 1980]



Sec.  556.320  Hydrocortisone.

    A tolerance is established for negligible residues of hydrocortisone 
(as hydrocortisone sodium succinate or hydrocortisone acetate) in milk 
at 10 parts per billion.



Sec.  556.330  Hygromycin B.

    A tolerance of zero is established for residues of hygromycin B in 
or on eggs and the uncooked edible tissues of swine and poultry.



Sec.  556.344  Ivermectin.

    (a) Acceptable daily intake (ADI). The ADI for total residues of 
ivermectin is 1 microgram per kilogram of body weight per day.
    (b) Tolerances--(1) Liver. A tolerance is established for 22,23-
dihydroavermectin B1a (marker residue) in liver (target 
tissue) as follows:
    (i) Cattle. 100 parts per billion.
    (ii) Swine. 20 parts per billion.
    (iii) Sheep. 30 parts per billion.
    (iv) Reindeer. 15 parts per billion.
    (v) American bison. 15 parts per billion.
    (2) Muscle. Muscle residues are not indicative of the safety of 
other edible tissues. A tolerance is established for 22,23-
dihydroavermectin B1a (marker residue) in muscle as follows:
    (i) Swine. 20 parts per billion.
    (ii) Cattle. 10 parts per billion.

[63 FR 54352, Oct. 9, 1998, as amended at 64 FR 26671, May 17, 1999]



Sec.  556.347  Lasalocid.

    (a) Acceptable daily intake (ADI). The ADI for total residues of 
lasalocid is 10 micrograms per kilogram of body weight per day.
    (b) Tolerances--(1) Cattle. The tolerance for parent lasalocid (the 
marker residue) in liver (the target tissue) is 0.7 part per million 
(ppm).
    (2) Chickens--(i) Skin with adhering fat (the target tissue). The 
tolerance for parent lasalocid (the marker residue) is 1.2 ppm.
    (ii) Liver. The tolerance for parent lasalocid (the marker residue) 
is 0.4 ppm.
    (3) Turkeys--(i) Liver (the target tissue). The tolerance for parent 
lasalocid (the marker residue) is 0.4 ppm.
    (ii) Skin with adhering fat. The tolerance for parent lasalocid (the 
marker residue) is 0.4 ppm.

[[Page 348]]

    (4) Rabbits. The tolerance for parent lasalocid (the marker residue) 
in liver (the target tissue) is 0.7 ppm.
    (5) Sheep. The tolerance for parent lasalocid (the marker residue) 
in liver (the target tissue) is 1.0 ppm.

[66 FR 19854, Apr. 18, 2001]



Sec.  556.350  Levamisole hydrochloride.

    A tolerance of 0.1 part per million is established for negligible 
residues of levamisole hydrochloride in the edible tissues of cattle, 
sheep, and swine.



Sec.  556.360  Lincomycin.

    (a) Acceptable daily intake (ADI). The ADI for total residues of 
lincomycin is 25 micrograms per kilogram of body weight per day.
    (b) Chickens. A tolerance for residues of lincomycin in chickens is 
not required.
    (c) Swine. Tolerances for lincomycin of 0.6 part per million in 
liver and 0.1 part per million in muscle are established.

[64 FR 13342, Mar. 18, 1999]



Sec.  556.375  Maduramicin ammonium.

    A tolerance is established for residues of maduramicin ammonium in 
chickens as follows:
    (a) A tolerance for maduramicin ammonium (marker residue) in 
chickens is 0.38 parts per million in fat (target tissue). A tolerance 
refers to the concentration of marker residues in the target tissue used 
to monitor for total drug residues in the target animals.
    (b) The safe concentrations for total maduramicin ammonium residues 
in uncooked edible chicken tissues are: 0.24 parts per million in 
muscle; 0.72 parts per million in liver; 0.48 parts per million in skin; 
and 0.48 parts per million in fat. A safe concentration refers to the 
total residue concentration considered safe in edible tissues.

[54 FR 5229, Feb. 2, 1989]



Sec.  556.380  Melengestrol acetate.

    A tolerance of 25 parts per billion is established for residues of 
the parent compound, melengestrol acetate, in fat of cattle.

[59 FR 41241, Aug. 11, 1994]



Sec.  556.390  Methylparaben.

    A tolerance of zero is established for residues of methylparaben in 
milk from dairy animals.



Sec.  556.400  Methylprednisolone.

    A tolerance is established for negligible residues of 
methylprednisolone in milk at 10 parts per billion.



Sec.  556.410  Metoserpate hydrochloride.

    A tolerance of 0.02 part per million is established for negligible 
residues of metoserpate hydrochloride (methyl-o- methyl-18-epireserpate 
hydrochloride) in uncooked edible tissues of chickens.



Sec.  556.420  Monensin.

    (a) Acceptable daily intake (ADI). The ADI for total residues of 
monensin is 12.5 micrograms per kilogram of body weight per day.
    (b) Tolerances--(1) Cattle and goats. A tolerance of 0.05 part per 
million is established for negligible residues of monensin in edible 
tissues of cattle and goats.
    (2) Chickens, turkeys, and quail. A tolerance for residues of 
monensin in chickens, turkeys, and quail is not needed.

[64 FR 5159, Feb. 3, 1999]



Sec.  556.425  Morantel tartrate.

    A tolerance of 0.7 part per million is established for N-methyl-1,3-
propanediamine (MAPA, marker residue) in the liver (target tissue) of 
cattle and goats. A tolerance for residues of morantel tartrate in milk 
is not required.

[59 FR 17922, Apr. 15, 1994]



Sec.  556.426  Moxidectin.

    (a) Acceptable daily intake (ADI). The ADI for total residues of 
moxidectin is 4 micrograms per kilogram of body weight per day.
    (b) Tolerances--(1) Cattle--(i) Liver (the target tissue). The 
tolerance for parent moxidectin (the marker residue) is 200 parts per 
billion (ppb).
    (ii) Muscle. The tolerance for parent moxidectin (the marker 
residue) is 50 ppb.

[[Page 349]]

    (iii) Milk. The tolerance for parent moxidectin (the marker residue 
in cattle milk) is 40 ppb.
    (2) [Reserved]

[65 FR 36617, June 9, 2000, as amended at 65 FR 76930, Dec. 8, 2000]



Sec.  556.428  Narasin.

    (a) Acceptable daily intake (ADI). The ADI for total residues of 
narasin is 5 micrograms per kilogram of body weight per day.
    (b) Tolerances--(1) Chickens (abdominal fat). The tolerance for 
parent narasin (the marker residue) is 480 parts per billion.
    (2) [Reserved]

[66 FR 23589, May 9, 2001]



Sec.  556.430  Neomycin.

    (a) Acceptable daily intake (ADI). The ADI for total residues of 
neomycin is 6 micrograms per kilogram of body weight per day.
    (b) Tolerances. Tolerances are established for residues of parent 
neomycin in uncooked edible tissues as follows:
    (1) Cattle, swine, sheep, and goats. 7.2 parts per million (ppm) in 
kidney (target tissue) and fat, 3.6 ppm in liver, and 1.2 ppm in muscle.
    (2) Turkeys. 7.2 ppm in skin with adhearing fat, 3.6 ppm in liver, 
and 1.2 ppm in muscle.
    (3) Milk. A tolerance is established for residues of parent neomycin 
of 0.15 ppm.

[64 FR 31498, June 11, 1999]



Sec.  556.440  Nequinate.

    A tolerance of 0.1 part per million is established for negligible 
residues of nequinate in the uncooked edible tissues of chickens.



Sec.  556.445  Nicarbazin.

    A tolerance of 4 parts per million is established for residues of 
nicarbazin in uncooked chicken muscle, liver, skin, and kidney.

[42 FR 56729, Oct. 28, 1977]



Sec.  556.460  Novobiocin.

    Tolerances for residues of novobiocin are established at 0.1 part 
per million in milk from dairy animals and 1 part per million in the 
uncooked edible tissues of cattle, chickens, turkeys, and ducks.

[47 FR 18590, Apr. 30, 1982]



Sec.  556.470  Nystatin.

    A tolerance of zero is established for residues of nystatin in or on 
eggs and the uncooked edible tissues of swine and poultry.



Sec.  556.480  Oleandomycin.

    Tolerances are established for negligible residues of oleandomycin 
in uncooked edible tissues of chickens, turkeys, and swine at 0.15 part 
per million.



Sec.  556.490  Ormetoprim.

    (a) [Reserved]
    (b) Tolerances. A tolerance of 0.1 part per million (ppm) is 
established for negligible residues of ormetoprim in uncooked edible 
tissues of chickens, turkeys, ducks, salmonids, catfish, and chukar 
partridges.

[64 FR 26672, May 17, 1999]



Sec.  556.495  Oxfendazole.

    Cattle: A tolerance is established for total oxfendazole residues in 
edible cattle tissues based on a marker residue concentration of 0.8 
part per million (ppm) fenbendazole in the target liver tissue. A 
fenbendazole concentration of 0.8 ppm in liver corresponds to a total 
safe concentration of oxfendazole residues of 1.7 ppm in liver. The safe 
concentrations of total oxfendazole residues in other uncooked edible 
cattle tissues are: muscle, 0.84 ppm; kidney, 2.5 ppm; and fat, 3.3 ppm. 
A tolerance refers to the concentration of marker residue in the target 
tissue selected to monitor for total drug residue in the target animal. 
A safe concentration is the total residue considered safe in edible 
tissue.

[55 FR 46943, Nov. 8, 1990]



Sec.  556.500  Oxytetracycline.

    (a) Acceptable daily intake (ADI). The ADI for total tetracycline 
residues (chlortetracycline, oxytetracycline, and tetracycline) is 25 
micrograms per kilogram of body weight per day.
    (b) Beef cattle, dairy cattle, calves, swine, sheep, chickens, 
turkeys, catfish,

[[Page 350]]

lobster, and salmonids. Tolerances are established for the sum of 
residues of the tetracyclines including chlortetracycline, 
oxytetracycline, and tetracycline, in tissues and milk as follows:
    (1) 2 parts per million (ppm) in muscle.
    (2) 6 ppm in liver.
    (3) 12 ppm in fat and kidney.
    (4) 0.3 ppm in milk.

[63 FR 57246, Oct. 27, 1998, as amended at 66 FR 46370, Sept. 5, 2001]



Sec.  556.510  Penicillin.

    Tolerances are established for residues of penicillin and the salts 
of penicillin in food as follows:
    (a) 0.05 part per million (negligible residue) in the uncooked 
edible tissues of cattle.
    (b) Zero in the uncooked edible tissues of chickens, pheasants, 
quail, swine, and sheep; in eggs; and in milk or in any processed food 
in which such milk has been used.
    (c) 0.01 part per million in the uncooked edible tissues of turkeys.

[40 FR 13942, Mar. 27, 1975, as amended at 43 FR 32749, July 28, 1978]



Sec.  556.513  Piperazine.

    A tolerance of 0.1 part per million piperazine base is established 
for edible tissues of poultry and swine.

[64 FR 23019, Apr. 29, 1999]



Sec.  556.515  Pirlimycin.

    (a) Acceptable daily intake (ADI). The ADI for total residues of 
pirlimycin is 0.01 milligrams per kilogram of body weight per day.
    (b) Tolerances--(1) Cattle--(i) Liver (the target tissue). The 
tolerance for parent pirlimycin (the marker residue) is 0.5 part per 
million (ppm).
    (ii) Muscle. The tolerance for parent pirlimycin (the marker 
residue) is 0.3 ppm.
    (iii) Milk. The tolerance for parent pirlimycin (the marker residue 
in cattle milk) is 0.4 ppm.
    (2) [Reserved]

[65 FR 61091, Oct. 16, 2000]



Sec.  556.520  Prednisolone.

    A tolerance of zero is established for residues of prednisolone in 
milk from dairy animals.



Sec.  556.530  Prednisone.

    A tolerance of zero is established for residues of prednisone in 
milk from dairy animals.



Sec.  556.540  Progesterone.

    No residues of progesterone are permitted in excess of the following 
increments above the concentrations of progesterone naturally present in 
untreated animals:
    (a) In uncooked edible tissues of steers and calves:
    (1) 3 parts per billion for muscle.
    (2) 12 parts per billion for fat.
    (3) 9 parts per billion for kidney.
    (4) 6 parts per billion for liver.
    (b) In uncooked edible tissues of lambs:
    (1) 3 parts per billion for muscle.
    (2) 15 parts per billion for fat, kidney, and liver.

[49 FR 13873, Apr. 9, 1984]



Sec.  556.550  Propylparaben.

    A tolerance of zero is established for residues of propylparaben in 
milk from dairy animals.



Sec.  556.560  Pyrantel tartrate.

    Tolerances are established for residues of pyrantel tartrate in 
edible tissues of swine as follows:
    (a) 10 parts per million in liver and kidney.
    (b) 1 part per million in muscle.



Sec.  556.570  Ractopamine.

    (a) Acceptable daily intake (ADI). The ADI for total residues of 
ractopamine is 1.25 micrograms ractopamine hydrochloride per kilogram of 
body weight per day.
    (b) Tolerances. Swine--Tolerances are established for residues of 
ractopamine hydrochloride parent (marker residue) in edible swine 
tissues of 0.05 part per million (ppm) in muscle, and 0.15 ppm in liver 
(target tissue). Residues of ractopamine in swine muscle are not

[[Page 351]]

indicative of the safety of residues in other edible tissue.

[65 FR 4112, Jan. 26, 2000]



Sec.  556.580  Robenidine hydrochloride.

    Tolerances are established for residues of robenidine hydrochloride 
in edible tissues of chickens as follows:
    (a) 0.2 part per million in skin and fat.
    (b) 0.1 part per million (negligible residue) in edible tissues 
other than skin and fat.



Sec.  556.590  Salicylic acid.

    A tolerance of zero is established for residues of salicylic acid in 
milk from dairy animals.



Sec.  556.592  Salinomycin.

    (a) Acceptable daily intake (ADI). The ADI for total residues of 
salinomycin is 0.005 milligram per kilogram of body weight per day.
    (b) [Reserved]

[65 FR 70791, Nov. 28, 2000]



Sec.  556.597  Semduramicin.

    (a) Acceptable daily intake (ADI). The ADI for total residues of 
semduramicin is 180 micrograms per kilogram of body weight per day.
    (b) Tolerances--(1) Broiler chickens. Tolerances are established for 
residues of parent semduramicin in uncooked edible tissues of 400 parts 
per billion (ppb) in liver and 130 ppb in muscle.
    (2) [Reserved]

[64 FR 48296, Sept. 3, 1999]



Sec.  556.600  Spectinomycin.

    (a) Acceptible daily intake (ADI). The ADI for total residues of 
spectinomycin is 25 micrograms per kilogram of body weight per day.
    (b) Chickens and turkeys. A tolerance of 0.1 part per million (ppm) 
for negligible residues of spectinomycin in uncooked edible tissues of 
chickens and turkeys is established.
    (c) Cattle. A tolerance of 4 ppm for parent spectinomycin (marker 
residue) in kidney (target tissue) is established. A tolerance of 0.25 
ppm for parent spectinomycin in cattle muscle is established.

[63 FR 24107, May 1, 1998; 63 FR 38304, July 16, 1998]



Sec.  556.610  Streptomycin.

    Tolerances are established for residues of streptomycin in uncooked, 
edible tissues of chickens, swine, and calves of 2.0 parts per million 
(ppm) in kidney and 0.5 ppm in other tissues.

[58 FR 47211, Sept. 8, 1993]



Sec.  556.620  Sulfabromomethazine sodium.

    Tolerances for residues of sulfabromomethazine sodium in food are 
established as follows:
    (a) In the uncooked edible tissues of cattle at 0.1 part per million 
(negligible residue).
    (b) In milk at 0.01 part per million (negligible residue).

[47 FR 30244, July 13, 1982]



Sec.  556.625  Sodium sulfachloropyrazine monohydrate.

    A tolerance of zero is established for residues of sodium 
sulfachloropyrazine monohydrate in the uncooked edible tissues of 
chickens.



Sec.  556.630  Sulfachlorpyridazine.

    A tolerance of 0.1 part per million is established for negligible 
residues of sulfachlorpyridazine in uncooked edible tissues of calves 
and swine.



Sec.  556.640  Sulfadimethoxine.

    (a) [Reserved]
    (b) Tolerances. (1) A tolerance of 0.1 part per million (ppm) is 
established for negligible residues of sulfadimethoxine in uncooked 
edible tissues of chickens, turkeys, cattle, ducks, salmonids, catfish, 
and chukar partridges.
    (2) A tolerance of 0.01 ppm is established for negligible residues 
of sulfadimethoxine in milk.

[64 FR 26672, May 17, 1999]



Sec.  556.650  Sulfaethoxypyridazine.

    Tolerances for residues of sulfaethoxypyridazine in food are 
established as follows:

[[Page 352]]

    (a) Zero in the uncooked edible tissues of swine and in milk.
    (b) 0.1 part per million (negligible residue) in uncooked edible 
tissues of cattle.



Sec.  556.660  Sulfamerazine.

    A tolerance of zero is established for residues of sulfamerazine 
(N\1\-[4-methyl-2-pyrimidinyl]sulfanilamide) in the uncooked edible 
tissues of trout.



Sec.  556.670  Sulfamethazine.

    A tolerance of 0.1 part per million is established for negligible 
residues of sulfamethazine in the uncooked edible tissues of chickens, 
turkeys, cattle, and swine.

[47 FR 25323, June 11, 1982]



Sec.  556.680  Sulfanitran.

    A tolerance of zero is established for residues of sulfanitran 
(acetyl(p- nitro-phenyl) sulfanilamide) and its metabolites in the 
uncooked edible tissues of chickens.



Sec.  556.685  Sulfaquinoxaline.

    A tolerance of 0.1 part per million is established for negligible 
residues of sulfaquinoxaline in the uncooked edible tissues of chickens, 
turkeys, calves, and cattle.

[61 FR 24443, May 15, 1996]



Sec.  556.690  Sulfathiazole.

    A tolerance of 0.1 part per million is established for negligible 
residues of sulfathiazole in the uncooked edible tissues of swine.



Sec.  556.700  Sulfomyxin.

    A tolerance of zero is established for residues of sulfomyxin (N-
sulfomethyl-polymyxin B sodium salt) in uncooked edible tissues from 
chickens and turkeys.



Sec.  556.710  Testosterone propionate.

    No residues of testosterone, resulting from the use of testosterone 
propionate, are permitted in excess of the following increments above 
the concentrations of testosterone naturally present in untreated 
animals:
    (a) In uncooked edible tissues of heifers:
    (1) 0.64 part per billion in muscle.
    (2) 2.6 parts per billion in fat.
    (3) 1.9 parts per billion in kidney.
    (4) 1.3 parts per billion in liver.
    (b) [Reserved]

[52 FR 27683, July 23, 1987]



Sec.  556.720  Tetracycline.

    (a) Acceptable daily intake (ADI). The ADI for total tetracycline 
residues (chlortetracycline, oxytetracycline, and tetracycline) is 25 
micrograms per kilogram of body weight per day.
    (b) Tolerances. Tolerances are established for the sum of 
tetracycline residues in tissues of calves, swine, sheep, chickens, and 
turkeys, of 2 parts per million (ppm) in muscle, 6 ppm in liver, and 12 
ppm in fat and kidney.

[63 FR 57246, Oct. 27, 1998]



Sec.  556.730  Thiabendazole.

    Tolerances are established at 0.1 part per million for negligible 
residues of thiabendazole in uncooked edible tissues of cattle, goats, 
sheep, pheasants, and swine, and at 0.05 part per million for negligible 
residues in milk.

[40 FR 13942, Mar. 27, 1975, as amended at 49 FR 29958, July 25, 1984]



Sec.  556.735  Tilmicosin.

    (a) Acceptable daily intake (ADI). The ADI for total residues of 
tilmicosin is 25 micrograms per kilogram of body weight per day.
    (b) Tolerances--(1) Cattle--(i) Liver (the target tissue). The 
tolerance for parent tilmicosin (the marker residue) is 1.2 parts per 
million (ppm).
    (ii) Muscle. The tolerance for parent tilmicosin (the marker 
residue) is 0.1 ppm.
    (2) Swine--(i) Liver (the target tissue). The tolerance for parent 
tilmicosin (the marker residue) is 7.5 ppm.
    (ii) Muscle. The tolerance for parent tilmicosin (the marker 
residue) is 0.1 ppm.
    (3) Sheep--(i) Liver (the target tissue). The tolerance for parent 
tilmicosin (the marker residue) is 1.2 ppm.
    (ii) Muscle. The tolerance for parent tilmicosin (the marker 
residue) is 0.1 ppm.

[64 FR 13679, Mar. 22, 1999, as amended at 67 FR 72368, Dec. 5, 2002]

[[Page 353]]



Sec.  556.738  Tiamulin.

    A tolerance of 0.6 part per million is established for 8-alpha-
hydroxymutilin (marker compound) in liver (target tissue) of swine.

[62 FR 12086, Mar. 14, 1997]



Sec.  556.739  Trenbolone.

    (a) Acceptable daily intake (ADI). The ADI for total residues of 
trenbolone is 0.4 microgram per kilogram of body weight per day.
    (b) Tolerances. A tolerance for total trenbolone residues in 
uncooked edible tissues of cattle is not needed.

[64 FR 18574, Apr. 15, 1999]



Sec.  556.740  Tylosin.

    Tolerances are established for residues of tylosin in edible 
products of animals as follows:
    (a) In chickens and turkeys: 0.2 part per million (negligible 
residue) in uncooked fat, muscle, liver, and kidney.
    (b) In cattle: 0.2 part per million (negligible residue) in uncooked 
fat, muscle, liver, and kidney.
    (c) In swine: 0.2 part per million (negligible residue) in uncooked 
fat, muscle, liver, and kidney.
    (d) In milk: 0.05 part per million (negligible residue).
    (e) In eggs: 0.2 part per million (negligible residue).



Sec.  556.741  Tripelennamine.

    A tolerance of 200 parts per billion (ppb) is established for 
residues of tripelennamine in uncooked edible tissues of cattle and 20 
ppb in milk.

[62 FR 4164, Jan. 29, 1997]



Sec.  556.750  Virginiamycin.

    (a) Acceptable daily intake (ADI). The ADI for total residues of 
virginiamycin is 250 micrograms per kilogram of body weight per day.
    (b) Tolerances--(1) Swine. Tolerances are established for residues 
of virginiamycin in uncooked edible tissues of 0.4 part per million 
(ppm) in kidney, skin, and fat, 0.3 ppm in liver, and 0.1 ppm in muscle.
    (2) Broiler chickens and cattle. A tolerance for residues of 
virginiamycin is not required.

[64 FR 48296, Sept. 3, 1999]



Sec.  556.760  Zeranol.

    (a) Acceptable daily intake (ADI). The ADI for total residues of 
zeranol is 0.00125 milligrams per kilogram of body weight per day.
    (b) Tolerances--(1) Cattle. Tolerances for residues of zeranol in 
edible tissues are not needed.
    (2) Sheep. No residues of zeranol may be found in the uncooked 
edible tissues of sheep as determined by the following method of 
analysis:

                     I. Method of Analysis--Zeranol

    A gas chromatographic method for the determination of the drug in 
frozen beef tissues is described. Tissue is frozen and stored in a deep 
freezer until ready for examination. A weighed portion of wet tissue 
(with exception of fat) is homogenized and lyophilized to dry solid. The 
drug is recovered from dry tissue by an extraction with methanol in a 
Soxhlet extractor. The methanol extract is digested in the presence of 
hydrochloric acid to hydrolyze conjugates should any be present. 
Elimination of impurities is brought about by liquid partition transfer 
successively to chloroform to 1N sodium hydroxide, to carbon 
tetrachloride, to 1N sodium hydroxide, to ethyl ether, and, finally, to 
a dry residue. The residue is reacted with a silane mixture to create a 
volatile derivative which is quantitated by peak area measurements from 
a flame ionization detector. The drug can be detected at a level of 20 
parts per billion with negligible interference from tissues or reagents.

                              II. Reagents

    A. Carbon tetrachloride, N.F., Fisher Scientific C-186, or 
equivalent.
    B. Chloroform, N.F., Fisher Scientific C-296, or equivalent.
    C. Chromatograph gases, flow rates adjusted to maximize sensitivity 
for specific chromatograph.
    1. Carrier gas, conventional tank helium.
    2. Flame makeup gas.
    a. Oxygen, conventional tank oxygen.
    b. Hydrogen, Linde high purity, or equivalent.
    D. Column packing, 3 percent GE SE-52 (Applied Science Laboratories) 
on P.E. Celite 60-80 mesh (Johns Manville Product No. 154-0048), or 
equivalent.
    E. Ether, anhydrous, Fisher Scientific E-138, or equivalent.

[[Page 354]]

    F. Hexamethyldisilazane, Dow-Corning, Peninsular, or equivalent.
    G. Hydrochloric acid, analytical reagent grade.
    H. Methanol, certified A.C.S., spectranalyzed, Fisher Scientific A-
408, or equivalent.
    I. Phosphoric acid, analytical reagent grade.
    J. Pyridine, anhydrous, A.C.S. reagent grade.
    K. Silating reagent mixture: Pipet 8 milliliters each of pyridine 
and hexamethyldisilazane and 4 milliliters of trimethylchlorosilane into 
a clean glass vial with a polyethylene cap and mix thoroughly. Let stand 
overnight and decant supernatant liquid into a vial. Cap and store at 
room temperature for daily use. If kept dry, the reagent is stable for 
more than a month. Blanks are scanned by gas chromatography on each new 
bottle of J, F, and N material used in the silating reagent mixture for 
possible peak interference in the region of zeranol derivative.
    L. Sodium chloride, analytical reagent grade.
    M. Sodium hydroxide, analytical reagent grade.
    N. Trimethylchlorosilane, Dow-Corning, Peninsular, or equivalent.
    O. Water, distilled in glass.
    P. Zeranol, primary standard.
    Q. Solutions.
    1. 2N Hydrochloric acid in water.
    2. 3N Phosphoric acid in water.
    3. 2 percent w/v solium chloride in water.
    4. 1N Sodium hydroxide in water.

                             III. Apparatus

    A. Extraction assemblies, Soxhlet, improved, standard taper 
grindings, Pyrex brand glass, 1,000 milliliters capacity, Sargent 
Catalog S-31265D, or equivalent.
    B. Flasks, freeze drying, widemouth, 1,000 milliliters capacity, 24/
40 standard taper grindings, Pyrex brand glass, Sargent Catalog S-28875-
20-F, or equivalent.
    C. Flasks, homogenizing, 250 milliliters, Sargent Catalog S-61716, 
or equivalent.
    D. Funnels, separatory, Squibb stopper, with Teflon stopcock plug, 
Pyrex brand glass, 250- and 500-milliliter capacities, Sargent Catalog 
S-35815-20-F or G, or equivalent.
    E. Gas chromatograph, F and M Model 5750 with flame ionization 
detector, or equivalent.
    F. Gas chromatography column: Stainless steel tubing, 6 feet by \3/
16\ inch packed with 3 percent by weight GE SE-52 (Applied Science 
Laboratories) deposited on P.E. Celite 60-80 mesh (product No. 154-
0048), or equivalent. Condition the column by baking for 40-80 hours at 
325 [deg]C. with a helium flow, but detached from the detector input. 
Injections of 1-2 microliters of a 50/50 mixture of hexamethyldisilazane 
and trimethylchlorosilane will help remove active sites in the column.
    1. Prepare a TMS derivative of a 1,000-microgram zeranol standard as 
described in the procedure section. Inject 1-microliter quantities to 
determine whether the column is responding to the conditioning. After 
the column shows a response at the 1,000-microgram level, proceed to 
smaller quantities to optimize conditions.
    2. The column and chromatograph must be conditioned to achieve a 
minimum sensitivity response so that a peak 5 millimeters in height 
results from an injection of 5 microliter of standard preparation 
containing 1 microgram of zeranol in the derivative preparation. This 
criterion must be met before tissue assay is attempted.
    3. The column is brought to 250 [deg]C. after conditioning and held 
at that temperature for at least 12 hours before making a run.
    G. Heating mantle, electric, Glas-Col. Sargent Catalog S-40866H, or 
equivalent.
    H. Hot plate, with gradient rheostat heat control.
    I. Meat grinder, manually operated or equivalent.
    J. Steam bath.
    K. Syringe, Hamilton Micro Syringe Model 701, 10-microliter 
capacity, or equivalent.
    L. Torsion balance, 0.1 gram sensitivity, 500 grams capacity.
    M. Vials, 1-dram glass with plastic tops, Owens-Illinois, Opticlear, 
or equivalent.
    N. Virtis freeze drier, Sargent Catalog S-28881-80, or equivalent.
    O. Virtis homogenizing mill, macro, Virtis No. 45, Sargent Catalog 
S-61700, or equivalent.

                         IV. Standard Solutions

    A. Stock solution A: Accurately weigh 0.1000 gram of zeranol, 
primary standard, into a 250-milliliter beaker. Dissolve the standard in 
80 milliliters of methanol and accurately dilute to 100 milliliters in a 
volumetric flask with methanol. By preparation, the solution contains 
1,000 micrograms per milliliter.
    B. Stock solution B: Dilute 10.0 milliliters of stock solution A to 
100 milliliters with methanol to provide a standard containing 100 
micrograms of the drug per milliliter.
    C. Stock solution C: Dilute 5.0 milliliters of stock solution B to 
100 milliliters with methanol to provide a standard of 5 micrograms per 
milliliter.
    D. Stock solution D: Dilute 2.0 milliliters of stock solution B to 
100 milliliters with methanol to provide a standard of 2 micrograms per 
milliliter. Transfer 1.0 milliliter of stock solution D to a 1-dram 
glass vial, evaporate to a dry residue in a vacuum desiccator at reduced 
pressure. The residue contains 2 micrograms of zeranol to be used

[[Page 355]]

as a calibration standard in operation of the gas chromatograph.

                              V. Procedure

    A. Preparation of glassware: Glassware should be washed in detergent 
or chromic acid solution to remove contaminants and rinsed in water to 
remove traces of cleaning agent. Rinse with methanol before using.
    B. Preparation of sample.
    1. Collect muscle, liver, kidney, and tripe from a freshly 
sacrificed animal under the cleanest conditions possible.
    2. Grind the fresh tissue in a meat grinder, divide into 100-gram 
portions, and wrap in aluminum foil. Store wrapped tissue in a deep 
freeze. Fat should be wrapped in foil and stored in deep freeze.
    C. Extraction procedure for muscle, liver, kidney, and tripe.
    1. Weight 100 grams of partially thawed tissue into a 250-milliliter 
homogenizing flask, add 60 milliliters of water, and attach to a Virtis 
``45'' Tissue Mill, or equivalent.
    2. Mix the materials at 45,000 r.p.m. for 5 minutes to obtain a thin 
homogenate.
    3. Transfer the homogenate to a 1-liter, widemouth, freeze drying 
flask using 10-20 milliliters of water for a rinse.
    4. Place the flask on its side in a nearly horizontal position in a 
slurry of dry ice and acetone. Rotate the flask on its side as the 
homogenate cools to set down a uniform frozen solid layer on the wall of 
the flask.
    5. Mount the flask on a Virtis freeze drier, or equivalent, and 
lyophilize to dry solids. This operation usually requires 20-24 hours. 
Stopping place.
    6. Transfer the solid cake to a clean sheet of paper and crumble by 
hand to a size convenient for transfer to an extraction thimble.
    7. Transfer the solids to a single thickness 60x180 milliliter 
Soxhlet extraction thimble and compact the solids sufficiently to 
guarantee complete immersion during solid extraction.
    8. Transfer 600 milliliters of methanol to a 1-liter pot of a 
Soxhlet extraction assembly and place the thimble in the extractor. 
Mount a large glass funnel in the neck of the extractor with the stem 
extending into the thimble. Rinse the 1-liter freeze drying flask with 
three 50-milliliter portions of fresh methanol and transfer the rinses 
through the funnel into the thimble. Mount the condenser in the 
extractor and extract the solids for 15 hours. The extractor should be 
heated with the electric heating mantle so that a fill-empty cycle 
requires 18-24 minutes.
    9. Drain the methanol from the thimble. Composite the methanol from 
the extractor and pot in an 800-milliliter beaker.
    10. Rinse the pot with 10 milliliters of methanol and add to the 
methanol composite. Transfer 50 milliliters of 2N HCl down the pot side 
wall, and add to methanol composite. Concentrate to 125 milliliters by 
boiling on a hot plate.
    D. Extraction procedure for fat.
    1. Cut fat into \1/4\-inch cubes. The lyophilization of fat is 
unnecessary since it is essentially water free.
    2. Transfer 100 grams of the prepared fat to a 60x180-millimeter 
extraction thimble and extract with 750 milliliters of methanol for 15 
hours in the Soxhlet extractor. The extractor should be heated with the 
electric heating mantle so that a fill-empty cycle requires 18-24 
minutes.
    3. Drain the methanol from the thimble. Composite the methanol from 
the extractor and pot into an 800-milliliter beaker.
    4. Rinse the pot with 10 milliliters of methanol and add to the 
methanol composite. Transfer 50 milliliters of 2N HCl down the pot side 
wall, and add to methanol composite. Concentrate to 125 milliliters by 
boiling on a hot plate.
    E. Solvent partition.
    1. Transfer the methanol concentrate to a 500-milliliter separatory 
funnel, identified by number as 1, with 70 milliliters of chloroform 
rinse and mix.
    2. Add 300 milliliters of water and without shaking allow liquid 
phases to separate.
    3. Withdraw the chloroform layer into a separatory funnel, 
identified by number as 2, containing 100 milliliters of 2 percent 
aqueous sodium chloride.
    4. Gently mix the contents of funnel 2 horizontally end to end 30 
times and allow phases to separate. Usually about 20 minutes are 
required to obtain maximum chloroform separation.
    5. Withdraw the chloroform layer into a beaker.
    6. Extract with shaking the contents of funnels 1 and 2 successively 
with three more 50-milliliter portions of chloroform.
    7. Composite the chloroform extracts and concentrate to 125 
milliliters by evaporation on a steam bath and cool to room temperature.
    8. Transfer the chloroform composite to a 250-milliliter separatory 
funnel, fitted with a Teflon stopcock, using 10 milliliters of 
chloroform as a rinse.
    9. Extract the chloroform with three separate 20-milliliter portions 
of 1N sodium hydroxide solution retaining the emulsion in the sodium 
hydroxide phase. Agitation of sodium hydroxide with the chloroform 
extract for the first time is accompanied by the appearance of emulsion.
    10. Perform an extraction by gently inverting the closed funnel and 
returning the funnel to an upright position.
    11. Repeat phase mixing 30 times per extraction.

[[Page 356]]

    12. Allow phases to separate for 10 minutes. The time delay allows 
for gradual dissipation of the emulsion to improve phase separation. The 
zeranol transfers from the chloroform to the upper sodium hydroxide 
phase in this operation.
    13. Composite the sodium hydroxide extracts.
    14. Wash the sodium hydroxide extract with three 50-milliliter 
portions of chloroform using the technique as in step 9 and the same 10-
minute interval for phase separation. Washing the chloroform removes the 
emulsion and unwanted impurities from the sodium hydroxide phase.
    15. Discard the chloroform washes. Transfer the sodium hydroxide 
extracts to a 250-milliliter beaker. Rinse each separatory funnel with 
two 5-milliliter portions of water and add to the sodium hydroxide 
extract. Wash each funnel twice with tap water and twice with distilled 
water before next use.
    16. Neutralize the washed sodium hydroxide extract to pH 8.0 by 
dropwise addition of 3N phosphoric acid using a pH meter for pH 
detection.
    17. Transfer the pH 8.0 water extract to a 250-milliliter separatory 
funnel using 10 to 20 milliliters of water for a rinse.
    18. Extract the solution with three separate 50-milliliter portions 
of carbon tetrachloride. The zeranol transfers to the lower carbon 
tetrachloride phase. Use the same 30-count phase-mixing technique as in 
step 9 and allow the mixture to stand 5 minutes for phase separation.
    19. Composite the carbon tetrachloride extracts.
    20. Extract the carbon tetrachloride composite with two 20-
milliliter portions of 1N sodium hydroxide. Zeranol transfers from 
carbon tetrachloride to the upper sodium hydroxide phase. After phase 
mixing, allow the mixture to stand 5 minutes for phase separation.
    21. Composite the sodium hydroxide extracts.
    22. Wash the extract with two 50-milliliter portions of carbon 
tetrachloride. Allow the mixture to stand 5 minutes for phase 
separation. Discard the carbon tetrachloride washes.
    23. Transfer the sodium hydroxide extract into a 250-milliliter 
beaker. Rinse the separatory funnel with two 5-milliliter portions of 
water and add to the sodium hydroxide extract. Wash each funnel twice 
with tap water and twice with distilled water before next use. Adjust 
the sodium hydroxide extract to a pH of 9.5 by dropwise addition of 3N 
phosphoric acid and transfer to a 250-milliliter separatory funnel using 
10-20 milliliters of water for a rinse.
    24. Extract the pH 9.5 water solution with three separate 30-
milliliter portions of anhydrous ethyl ether. Allow the mixture to stand 
5 minutes for phase separation. The zeranol transfers to the upper ether 
phase.
    25. Composite the ether extracts in a 125-milliliter Erlenmeyer 
flask.
    26. Reduce the volume of ether to about 1-2 milliliters by 
evaporation on a hot plate with low heat while removing vapor from top 
of flask by vacuum aspiration.
    27. Transfer ether residue to a 1-dram glass vial. Rinse down flask 
side wall with 1-2 milliliters of fresh ether and transfer to the glass 
vial.
    28. Continue evaporation of ether to 0.1 milliliter.
    29. Place vial in a vacuum desiccator and evaporate residue at line 
vacuum and room temperature overnight to dryness.
    30. Close vial with a plastic cap and submit ether residue for 
preparation of TMS derivative and gas chromatographic assay. Stopping 
place.
    F. Gas liquid chromatography.
    1. Start the gas chromatography and maintain the following 
operational conditions:
    Carrier gas pressure: 50 p.s.i. at tank.
    Carrier gas flow rate: Sufficient to give zeranol derivative peak a 
retention time of 4-8 minutes.
    Electrometer range: 10\2\ or 10\1\.
    Detector temperature: 325 [deg]C.
    Injection port temperature: 325 [deg]C.
    Column temperature: 250[deg]-280 [deg]C., operate isothermally.
    Recorder sensitivity: 1 millivolt.
    Recorder chart speed: 1 inch per minute.
    Sample size: 1 microliter to 5 microliters as necessary to give 
desired peak area for quantitative measurement.
    Septums: Replace each evening and allow to condition overnight at 
operational temperature.
    Flame assembly: Remove silica ash from the flame assembly each week. 
The flame assembly is removed; the anode, flame jet, and chimney are 
cleaned with a nylon bristle brush. Water and acetone are drawn through 
the jet capillary to remove any foreign material.
    2. Add 0.2 milliliter of silating reagent to the sample or to the 
zeranol standard.
    3. Stopper the vial and shake vigorously.
    4. Warm the vial at 40[deg]-50 [deg]C. for a few minutes, then roll 
the vial on a horizontal plane to insure that all of the interior 
surfaces of the vial have been in contact with the reagent.
    5. Let vial stand for 4 hours or overnight in a warm area (40 
[deg]C.) to allow reaction to reach completion.
    6. Place vial in a small padded centrifuge tube and centrifuge to 
settle the precipitate and insure that all the liquid is at the bottom 
of the vial.
    7. Inject 1.0-5.0 microliters of clear solution into the 
chromatograph. At the beginning of the day's run, make 3-5 injections of

[[Page 357]]

a standard to condition the column for that day before taking 
quantitative data.
    8. Run known mixtures at the beginning, middle, and end of the day's 
run over the concentration range of samples to be analyzed to compensate 
for day-to-day sensitivity fluctuations and drift. If four or less 
samples are to be run, calibrating at the beginning and end of the run 
is sufficient.

                            VI. Calculations

    Area values are obtained on known mixtures and samples by 
multiplying the net peak height by the peak width at half height or by 
counting squares. Area values obtained on knowns are plotted versus 
zeranol concentration. Calibration plots indicate a near linear function 
in the 0-10 microgram range. Area values obtained on samples are 
converted directly to microgram quantities using the curve. Control 
tests demonstrated a 70 percent recovery of zeranol from spiked wet beef 
liver and muscle necessitating a correction factor.
[GRAPHIC] [TIFF OMITTED] TR01JA93.411

Where:
0.7=Correction factor for 70 percent recovery.
W=Grams of tissue examined.

                           VII. Recovery Study

    A. Fortification of reagent blank.
    1. For those using this method for the first time either for 
recovery study or tissue assay, a solvent blank and solvent fortified 
with zeranol should be processed through the entire procedure. This 
preliminary operation will establish whether or not the procedure is 
free from contamination arising from solvents and glassware and 
demonstrate the level of recovery of the standard zeranol. Level of 
recovery should be in the same range as the samples.
    2. Transfer 600 milliliters of methanol to a 1-liter beaker. Add 50 
milliliters of 2N HCl to the methanol and concentrate to 125 milliliters 
by boiling on a hot plate.
    3. Transfer 600 milliliters of methanol to a 1-liter beaker. Add 50 
milliliters of 2N HCl to the methanol and concentrate to 125 milliliters 
by boiling on a hot plate. Spike the concentrate with 1.0 milliliter of 
stock solution D.
    4. Assay both samples as described in the procedure beginning 
extraction step V-E1.
    B. Fortification of samples.
    1. Transfer 100-gram portions of partially thawed tissues into 250-
milliliter homogenizing flasks and set half of them aside to serve as 
tissue blanks.
    2. Add to the remaining samples 1 milliliter of stock solution D to 
serve as fortified samples to which 20 parts per billion zearalanol have 
been added.
    3. Assay both fortified and unfortified tissue as described in the 
procedure section beginning with V-C1.

[40 FR 13942, Mar. 27, 1975, as amended at 54 FR 31950, Aug. 3, 1989; 67 
FR 6867, Feb. 14, 2002]



Sec.  556.770  Zoalene.

    Tolerances are established for residues of zoalene (3,5-dinitro-o- 
toluamide) and its metabolite 3-amino-5-nitro-o-toluamide in food as 
follows:
    (a) In edible tissues of chickens:
    (1) 6 parts per million in uncooked liver and kidney.
    (2) 3 parts per million in uncooked muscle tissue.
    (3) 2 parts per million in uncooked fat.
    (b) In edible tissues of turkeys: 3 parts per million in uncooked 
muscle tissue and liver.



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 New animal drug requirements for liquid Type B feeds.
558.6 Veterinary feed directive drugs.
558.15 Antibiotic, nitrofuran, and sulfonamide drugs in the feed of 
          animals.

      Subpart B--Specific New Animal Drugs For Use in Animal Feeds

558.35 Aklomide.
558.55 Amprolium.
558.58 Amprolium and ethopabate.
558.59 Apramycin.
558.60 Arsanilate sodium.
558.62 Arsanilic acid.
558.76 Bacitracin methylene disalicylate.
558.78 Bacitracin zinc.
558.95 Bambermycins.
558.105 [Reserved]
558.115 Carbadox.
558.120 Carbarsone (not U.S.P.).
558.128 Chlortetracycline.
558.140 Chlortetracycline and sulfamethazine.
558.145 Chlortetracycline, procaine penicillin, and sulfamethazine.
558.155 Chlortetracycline, sulfathiazole, penicillin.
558.175 Clopidol.

[[Page 358]]

558.185 Coumaphos.
558.195 Decoquinate.
558.198 Diclazuril.
558.205 Dichlorvos.
558.235 Efrotomycin.
558.248 Erythromycin thiocyanate.
558.254 Famphur.
558.258 Fenbendazole.
558.265 Halofuginone hydrobromide.
558.274 Hygromycin B.
558.295 Iodinated casein.
558.300 Ivermectin.
558.305 Laidlomycin.
558.311 Lasalocid.
558.315 Levamisole hydrochloride (equivalent).
558.325 Lincomycin.
558.340 Maduramicin ammonium.
558.342 Melengestrol.
558.348 Mibolerone.
558.355 Monensin.
558.360 Morantel tartrate.
558.363 Narasin.
558.364 Neomycin sulfate.
558.365 Nequinate.
558.366 Nicarbazin.
558.369 Nitarsone.
558.376 Nitromide and sulfanitran.
558.415 Novobiocin.
558.430 Nystatin.
558.435 Oleandomycin.
558.450 Oxytetracycline.
558.460 Penicillin.
558.464 Poloxalene.
558.465 Poloxalene free-choice liquid Type C feed.
558.485 Pyrantel tartrate.
558.500 Ractopamine.
558.515 Robenidine hydrochloride.
558.530 Roxarsone.
558.550 Salinomycin.
558.555 Semduramicin.
558.575 Sulfadimethoxine, ormetoprim.
558.579 Sulfaethoxypyridazine.
558.582 Sulfamerazine.
558.586 Sulfaquinoxoline.
558.600 Tiamulin.
558.615 Thiabendazole.
558.618 Tilmicosin.
558.625 Tylosin.
558.630 Tylosin and sulfamethazine.
558.635 Virginiamycin.
558.680 Zoalene.

    Authority: 21 U.S.C. 360b, 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 species for which they are approved.
    (ii) Category II--These drugs require a withdrawal period at the 
lowest use level for at least one species for which they are approved, 
or are regulated on a ``no-residue'' basis or with a zero tolerance 
because of a carcinogenic concern regardless of whether a withdrawal 
period is required, or are a veterinary feed directive drug.
    (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.
    (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,

[[Page 359]]

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 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.
    (6) A ``veterinary feed directive (VFD) drug'' is a new animal drug 
approved under section 512(b) of the Federal Food, Drug, and Cosmetic 
Act (the act) for use in or on animal feed. Use of a VFD drug must be 
under the professional supervision of a licensed veterinarian.
    (7) A ``veterinary feed directive'' is a written statement issued by 
a licensed veterinarian in the course of the veterinarian's professional 
practice that orders the use of a veterinary feed directive (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 the VFD drug in or on an animal feed to treat the client's animals 
only in accordance with the directions for use approved by the Food and 
Drug Administration (FDA). A veterinarian may issue a VFD only if a 
valid veterinarian-client-patient relationship exists, as defined in 
Sec.  530.3(i) of this chapter.
    (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 
distributor or to the client-recipient of the 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 communication 
provided to a distributor by a consignee who is not the ultimate user of 
medicated feed containing a VFD drug. An acknowledgment letter affirms 
that the consignee will not ship such medicated animal feed to an animal 
production facility that does not have a VFD, and will not ship such 
feed to another distributor without receiving a similar written 
acknowledgment letter.

[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]



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 and in 
Sec. Sec.  510.515 and 558.15 of this chapter.
    (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

[[Page 360]]

medicated articles and Type B and Type C medicated feeds, as follows:

                                                   Category I
----------------------------------------------------------------------------------------------------------------
                                      Assay limits
                Drug                   percent \1\      Type B maximum (200x)      Assay limits percent \1\ type
                                         type A                                               B/C \2\
----------------------------------------------------------------------------------------------------------------
Aklomide............................        90-110  22.75 g/lb (5.0%)...........  85-120.
Amprolium with Ethopabate...........        94-114  22.75 g/lb (5.0%)...........  80-120.
Bacitracin methylene disalicylate...        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.
Buquinolate.........................        90-110  9.8 g/lb (2.2%).............  80-120.
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.
Erythromycin (thiocyanate salt).....        85-115  9.25 g/lb (2.04%)...........  <20g/ton 70-115/150-50:20g/ton 75-125.
Iodinated casein....................        85-115  20.0 g/lb (4.4%)............  75-125.
Laidlomycin propionate                      90-110  1 g/lb (0.22%)..............  90-115/85-115.
 [chyph]potassium.
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.
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  7.2 g/lb (1.6%).............  85-115/75-125.
Nequinate...........................        95-112  1.83 g/lb (0.4%)............  80-120.
Niclosamide.........................        85-120  225g/lb (49.5%).............  80-120.
Nystatin............................        85-125  5.0 g/lb (1.1%).............  75-125.
Oleandomycin........................        85-120  1.125 g/lb (0.25%)..........   <11.25 g/ton 70-130; 11.25 g/ton 75-125.
Oxytetracycline.....................        90-120  20.0 g/lb (4.4%)............  75-125/65-135.
Penicillin..........................        80-120  10.0 g/lb (2.2%)............  65-135.
Poloxalene..........................        90-110  54.48 g/lb (12.0%)..........  Liq. feed: 85-115.
Ractopamine.........................        85-105  1.8 g/lb (0.4%).............  80-110/75-125.
Salinomycin.........................        95-115  6.0 g/lb (1.3%).............  80-120.
Semduramicin........................        90-110  2.25 g/lb (0.50%)...........  80-110.
Tiamulin............................   113.4 g/lb,  3.5 g/lb (0.8%).............  90-115.
                                           100-108
                                       5 and 10 g/  ............................  70-130.
                                        1b, 90-115
Tylosin.............................        80-120  10.0 g/lb (2.2%)............  75-125.
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.


                                                   Category II
----------------------------------------------------------------------------------------------------------------
                                      Assay limits
                Drug                   percent \1\      Type B maximum (100x)      Assay limits percent \1\ Type
                                         Type A                                               B/C \2\
----------------------------------------------------------------------------------------------------------------
Amprolium...........................        94-114  11.35 g/lb (2.5%)...........  80-120.
Apramycin...........................        88-112  7.5 g/lb (1.65%)............  80-120.
Arsanilate sodium...................        90-110  4.5 g/lb (1.0%).............  85-115/75-125.
Arsanilic acid......................        90-110  4.5 g/lb (1.0%).............  85-115/75-125.
Carbadox............................        90-110  2.5 g/lb (0.55%)............  75-125.
Carbarsone..........................        93-102  17.0 g/lb (3.74%)...........  85-115.
Clopidol............................        94-106  11.4 g/lb (2.5%)............  90-115/80-120.
Famphur.............................       100-110  5.5 g/lb (1.21%)............  90-115/80-120.

[[Page 361]]

 
Fenbendazole........................        93-113  8.87 g/lb (1.96%)...........  75-125
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.
Levamisole..........................        85-120  113.5 g/lb (25%)............  85-125.
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  7.0 g/lb (1.54%)............  70-125.
  Oxytetracycline...................        80-120  10.0 g/lb (2.2%)............  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
  Narasin...........................        90-110  5.675 g/lb (1.25%)..........  85-115/75-125
Nicarbazin (powder).................        98-106  5.675 g/lb (1.25%)..........  85-115/80-120
Nitarsone...........................        90-110  8.5 g/lb (1.87%)............  85-120.
Nitromide...........................        90-110  11.35 g/lb (2.5%)...........  80-120.
  Sulfanitran.......................        85-115  13.6 g/lb (3.0%)............  75-125.
Nitromide...........................        90-110  11.35 g/lb (2.5%)...........  85-115.
  Sulfanitran.......................        85-115  5.65 g/lb (1.24%)...........  75-125.
  Roxarsone.........................        90-110  2.275 g/lb (0.5%)...........  85-120.
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.
Ronnel..............................        85-115  27.2 g/lb (6.0%)............  80-120.
Roxarsone...........................        90-110  2.275 g/lb (0.5%)...........  85-120.
Roxarsone...........................        90-110  2.275 g/lb (0.5%)...........  85-120.
  Aklomide..........................        90-110  11.35 g/lb (2.5%)...........  85-120.
Roxarsone...........................        90-110  2.275 g/lb (0.5%)...........  85-120.
  Clopidol..........................        94-106  11.35 g/lb (2.5%)...........  80-120.
  Bacitracin methylene disalicylate.        85-115  5.0 g/lb (1.1%).............  70-130.
Roxarsone...........................        90-110  2.275 g/lb (0.5%)...........  85-120.
  Monensin..........................        90-110  5.5 g/lb (1.2%).............  75-125.
Sulfadimethoxine....................        90-110  5.675 g/lb (1.25%)..........  85-115/75-125.
  Ormetoprim (5/3)..................        90-110  3.405 g/lb (0.75%)..........  85-115.
Sulfadimethoxine....................        90-110  85.1 g/lb (18.75%)..........  85-115/75-125.
  Ormetoprim (5/1)..................        90-110  17.0 g/lb (3.75%)...........  85-115.
Sulfaethoxypyridazine...............        95-105  50.0 g/lb (11.0%)...........  85-115.
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.
  Penicillin........................        85-115  5.0 g/lb (1.1%).............  85-125/70-130.
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.
Sulfanitran.........................        85-115  13.6 g/lb (3.0%)............  75-125.
  Aklomide..........................        90-110  11.2 g/lb (2.5%)............  85-120.
Sulfanitran.........................        85-115  13.6 g/lb (3.0%)............  75-125.
  Aklomide..........................        90-110  11.2 g/lb (2.5%)............  85-120.
  Roxarsone.........................        90-110  2.715 g/lb (0.60%)..........  85-120.
Sulfanitran.........................        85-115  13.6 g/lb (3.0%)............  75-125.
  Aklomide..........................        90-110  11.2 g/lb (2.5%)............  85-120.
  Roxarsone.........................        90-110  2.27 g/lb (0.5%)............  85-120.
Sulfaquinoxaline....................        98-106  11.2 g/lb (2.5%)............  85-115.
Sulfathiazole.......................        85-115  10.0 g/lb (2.2%)............  80-120.
  Chlortetracycline.................        85-125  10.0g/lb (2.2%).............  70-130.
  Penicillin........................        80-120  5.0 g/lb (1.1%).............  70-130.
Thiabendazole.......................        94-106  45.4 g/lb (10.0%)...........  7% 85-115; <7% 90-
                                                                                   110.
Tilmicosin..........................        90-110  18.2 g/lb (4.0%)............  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 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.


[[Page 362]]

    (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 on GPO Access.



Sec.  558.5  New animal drug requirements for liquid Type B feeds.

    (a) Information available to the Commissioner of Food and Drugs 
shows that certain drugs are unstable when added to some liquid Type B 
medicated feeds. The demonstrated instability of these drugs gives rise 
to the question of the stability of other drugs when added to liquid 
Type B medicated feeds, except where specific approval has been granted 
for such use. Therefore, the labeling of a drug to provide for its use 
in a liquid Type B medicated feed causes the drug to be a new animal 
drug for such use for which an approved new animal drug application is 
required pursuant to section 512(b) of the Federal Food, Drug, and 
Cosmetic Act.
    (b) The addition of a drug to a liquid Type B medicated feed causes 
such Type B feed to become an animal feed bearing or containing a new 
animal drug for which an approved application is required pursuant to 
section 512(m) of the act.
    (c) Each drug product, intended for oral administration to animals, 
which contains any of the drugs listed in paragraph (d) of this section 
and which bears labeling for its use in animal feed and/or drinking 
water shall also include in such labeling the following statement: ``FOR 
USE IN ------ ONLY. NOT FOR USE IN LIQUID TYPE B MEDICATED FEEDS,'' the 
blank being filled in with the words ``DRY FEEDS,'' ``DRINKING WATER,'' 
``DRY FEEDS AND DRINKING WATER'' as applicable, unless:
    (1) Such drug product is the subject of an approved new animal drug 
application providing for its use in liquid Type B medicated feeds, or;
    (2) The labeling provisions of this paragraph have been waived on 
the basis of approval of a petition which includes a copy of the product 
label; a description of the formulation; and information which 
establishes that the physical, chemical, or other properties of the 
particular drug product are such that it cannot reasonably be expected 
to be diverted for use in liquid Type B medicated feeds. Such petitions 
shall be submitted to the Food and Drug Administration, Center for 
Veterinary Medicine, 7500 Standish Pl., Rockville, MD 20855.
    (d) The labeling provisions of paragraph (c) of this section apply 
to all forms of bacitracin, oxytetracycline, and chlortetracycline.
    (e) For any drug which is the subject of an approved new animal drug 
application, the labeling provisions of paragraph (c) of this section 
may be implemented without prior approval as provided for in Sec.  
514.8(d) and (e) of this chapter.

[40 FR 13959, Mar. 27, 1975, as amended at 52 FR 2684, Jan. 26, 1987; 57 
FR 6475, Feb. 25, 1992]



Sec.  558.6  Veterinary feed directive drugs.

    (a) What conditions must I meet if I am a veterinarian issuing a 
veterinary feed directive (VFD)?
    (1) You must be appropriately licensed.
    (2) You must issue a VFD only within the confines of a valid 
veterinarian-client-patient relationship (see definition at Sec.  
530.3(i) of this chapter).
    (3) You must complete the VFD in writing and sign it or it will be 
invalid.
    (4) You must include all of the following information in the VFD or 
it will be invalid:
    (i) You and your client's name, address and telephone and, if the 
VFD is faxed, facsimile number.
    (ii) Identification and number of animals to be treated/fed the 
medicated feed, including identification of the species of animals, and 
the location of the animals.
    (iii) Date of treatment, and, if different, date of prescribing the 
VFD drug.
    (iv) Approved indications for use.
    (v) Name of the animal drug.
    (vi) Level of animal drug in the feed, and the amount of feed 
required to

[[Page 363]]

treat the animals in paragraph (a)(4)(ii) of this section.
    (vii) Feeding instructions with the withdrawal time.
    (viii) Any special instructions and cautionary statements necessary 
for use of the drug in conformance with the approval.
    (ix) Expiration date of the VFD.
    (x) Number of refills (reorders) if necessary and permitted by the 
approval.
    (xi) Your license number and the name of the State issuing the 
license.
    (xii) The statement: ``Extra-label use, (i.e., use of this VFD feed 
in a manner other than as provided for in the VFD drug approval) is 
strictly prohibited.''
    (xiii) Any other information required by the VFD drug approval 
regulation.
    (5) You must produce the VFD in triplicate.
    (6) You must issue a VFD only for the approved conditions and 
indications for use of the VFD drug.
    (b) What must I do with the VFD if I am a veterinarian?
    (1) You must give the original VFD to the feed distributor (directly 
or through the client).
    (2) You must keep one copy of the VFD.
    (3) You must give the client a copy of the VFD.
    (4) You may send a VFD to the client or distributor by facsimile or 
other electronic means provided you assure that the distributor receives 
the original signed VFD within 5 working days of receipt of the 
facsimile or other electronic order.
    (5) You may not transmit a VFD by telephone.
    (c) What are the VFD recordkeeping requirements?
    (1) The VFD feed distributor must keep the VFD original for 2 years 
from the date of issuance. The veterinarian and the client must keep 
their copies for the same period of time.
    (2) All involved parties must make the VFD available for inspection 
and copying by FDA.
    (3) All involved parties (the VFD feed distributor, the 
veterinarian, and the client) must keep VFD's transmitted by facsimile 
or other electronic means for a period of 2 years from date of issuance.
    (4) All involved parties must have a copy of the VFD before 
distribution of a VFD feed to the ultimate user.
    (d) What are the notification requirements if I am a distributor of 
animal feed containing a VFD drug?
    (1) You must notify FDA only once, by letter, that you intend to 
distribute animal feed containing a VFD drug.
    (i) The notification letter must include the complete name and 
address of each business site from which distribution will occur.
    (ii) A responsible person from your firm must sign and date the 
notification letter.
    (iii) You must submit the notification letter to the Center for 
Veterinary Medicine, Division of Animal Feeds (HFV-220), 7500 Standish 
Pl., Rockville, MD 20855, prior to beginning your first distribution.
    (iv) You must notify the Center for Veterinary Medicine at the above 
address within 30 days of any change in name or business address.
    (2) If you are a distributor who ships an animal feed containing a 
VFD drug to another consignee-distributor in the absence of a valid VFD, 
you must obtain an ``acknowledgment letter,'' as defined in Sec.  
558.3(b)(11), from the consignee-distributor. The letter must include a 
statement affirming that the consignee-distributor has complied with 
``distributor notification'' requirements of paragraph (d)(1) of this 
section.
    (e) What are the additional recordkeeping requirements if I am a 
distributor?
    (1) You must keep records of receipt and distribution of all 
medicated animal feed containing a VFD drug.
    (2) You must keep these records for 2 years from date of receipt and 
distribution.
    (3) You must make records available for inspection and copying by 
FDA.
    (f) What cautionary statements are required for VFD drugs and animal 
feeds containing VFD drugs? All labeling and advertising must 
prominently and conspicuously display the following cautionary 
statement: ``Caution: Federal law limits this drug to use under the 
professional supervision of a licensed veterinarian. Animal feed bearing 
or containing this veterinary

[[Page 364]]

feed directive drug shall be fed to animals only by or upon a lawful 
veterinary feed directive issued by a licensed veterinarian in the 
course of the veterinarian's professional practice.''

[65 FR 76929, Dec. 8, 2000]



Sec.  558.15  Antibiotic, nitrofuran, and sulfonamide drugs in the feed of animals.

    (a) The Commissioner of Food and Drugs will propose to revoke 
currently approved subtherapeutic (increased rate of gain, disease 
prevention. etc.) uses in animal feed of antibiotic and sulfonamide 
drugs whether granted by approval of new animal drug applications, 
master files and/or antibiotic or food additive regulations, by no later 
than April 20, 1975, or the nitrofuran drugs by no later than September 
5, 1975, unless data are submitted which resolve conclusively the issues 
concerning their safety to man and animals and their effectiveness under 
specific criteria established by the Food and Drug Administration based 
on the guidelines included in the report of the FDA task force on the 
use of antibiotics in animal feeds. All persons or firms previously 
marketing identical, related, or similar products except the nitrofuran 
drugs not the subject of an approved new animal drug application must 
submit a new animal drug application by July 19, 1973, or by December 4, 
1973, in the case of nitrofuran drugs, if marketing is to continue 
during the interim. New animal drug entities with antibacterial activity 
not previously marketed, now pending approval or submitted for approval 
prior to, on, or following the effective date of this publication, shall 
satisfy such criteria prior to approval.
    (b) Any person interested in developing data which will support 
retaining approval for such uses of such antibiotic, nitrofuran, and 
sulfonamide drugs pursuant to section 512(l) of the Federal Food, Drug, 
and Cosmetic Act shall submit to the Commissioner the following:
    (1) By July 19, 1973, records and reports of completed, ongoing, or 
planned studies, including protocols, on the tetracyclines, 
streptomycin, dihydrostreptomycin, penicillin, and the sulfonamides; for 
all other antibiotics by October 17, 1973; and for the nitrofuran drugs 
by March 4, 1974. The Food and Drug Administration encourages sponsors 
to consult with the Center for Veterinary Medicine on protocol design 
and plans for future studies.
    (2) By April 20, 1974, data from completed studies on the 
tetracyclines, streptomycin, dihydrostreptomycin, the sulfonamides, and 
penicillin assessing the effect of the subtherapeutic use of the drug in 
feed on the salmonella reservoir in the target animal as compared to 
that in nonmedicated controls. Failure to complete the salmonella 
studies for any of these drugs by that time will be grounds for 
proceeding to immediately withdraw approval.
    (3) By April 20, 1975, data satisfying all other specified criteria 
for safety and effectiveness, including the effect on the salmonella 
reservoir for any antibiotic or sulfonamide drugs and by September 5, 
1975, for the nitrofuran drugs, approved for subtherapeutic use in 
animal feeds. Drug efficacy data shall be submitted for any feed-use 
combination product containing such drug and any feed-use single 
ingredient antibiotic, nitrofuran, or sulfonamide not reviewed by the 
National Academy of Sciences--National Research Council, Drug Efficacy 
Study covering drugs marketed between 1938 and 1962.
    (4) Progress reports on studies underway every January 1 and July 1 
until completion.
    (c) Failure on the part of any sponsor to comply with any of the 
provisions of paragraph (b) of this section for any of the antibacterial 
drugs included in paragraph (b)(1) of this section, or interim results 
indicating a health hazard, will be considered as grounds for 
immediately proceeding to withdraw approval of that drug for use in 
animal feeds under section 512(l) of the act in the case of failure to 
submit required records and reports and under section 512(e) where new 
information shows that such drug is not shown to be safe.
    (d) Criteria based upon the guidelines laid down by the task force 
may be obtained from the Food and Drug Administration, Center for 
Veterinary Medicine, 7500 Standish Pl., Rockville, MD 20855.

[[Page 365]]

    (e) Reports as specified in this section shall be submitted to: Food 
and Drug Administration, Center for Veterinary Medicine, Office of New 
Animal Drug Evaluation (HFV-100), 7500 Standish Pl., Rockville, MD 
20855.
    (f) Following the completion of the requirements of paragraphs (a) 
and (b) of this section and the studies provided for therein:
    (1) Those antibiotic, nitrofuran, and sulfonamide drugs which fail 
to meet the prescribed criteria for subtherapeutic uses but which are 
found to be effective for the therapeutic purposes will be permitted in 
feed only for high-level, short-term therapeutic use and only by or on 
the order of a licensed veterinarian.
    (2) Animal feeds containing antibacterial drugs permitted to remain 
in use for subtherapeutic purposes shall be labeled to include a 
statement of the quantity of such drugs.
    (g) The submission of applications and data required by paragraphs 
(a) and (b) of this section is not required for the continued 
manufacture of any Type A medicated article which is produced solely 
from a Type A article that is in compliance with the requirements of 
this section: Provided, That the Type A medicated article contains no 
drug ingredient whose use in or on animal feed requires an approved 
application pursuant to section 512(m) of the act and/or where the Type 
A article is approved by regulation in this part.
    (1) The following antibacterial Type A articles manufactured by the 
designated sponsors are eligible for interim marketing based on their 
compliance with the requirements of this section:

----------------------------------------------------------------------------------------------------------------
                                                                                                Indications for
          Drug sponsor              Type A article          Species            Use levels             use
----------------------------------------------------------------------------------------------------------------
Pitman-Moore, Inc..............  Bacitracin zinc....  Chickens, turkeys,   Sec. 558.78.......  Sec. 558.78.
                                                       swine, pheasants,
                                                       quail, and cattle.
A. L. Laboratories, Inc........  ......do...........  Chickens, turkeys,   ......do..........   Do.
                                                       pheasants, and
                                                       quail.
A.L. Laboratories, Inc.,         Bacitracin           Chicken turkeys,     Sec. 558.76.......  Sec. 558.76.
 Fermenta Animal Health Co..      methylene            swine, and cattle.
                                  disalicylate.
Elanco Products Co.............  Hygromycin B.......  Chickens and swine.  Sec. 558.274......  Sec. 558.274.
 Do............................  Tylosin............  Chickens, swine,     Sec. 558.625......  Sec. 558.625.
                                                       and beef cattle.
Sanofi Animal Health, Inc......  Erythromycin.......  Chickens, turkeys,   Sec. 558.248......  Sec. 558.248.
                                                       and swine.
The Upjohn Co..................  Lincomycin.........  Chickens...........  Sec. 558.325......  Sec. 558.325.
Pfizer, Inc....................  Oleandomycin.......  Chickens, turkeys,   Sec. 558.435......  Sec. 558.435.
                                                       and swine.
Hoechst-Roussel Agri-Vet, Inc..  Bambermycins.......  Chickens...........  Sec. 558.95.......  Sec. 558.95.
Elanco Products Co.............  Tylosin and          Swine..............  Sec. 558.630......  Sec. 558.630.
                                  sulfamethazine.
American Cyanamid Co., Fermenta  Chlortetracycline..  Chickens, turkeys,   Sec. 558.128......  Sec. 558.128.
 Animal Health Co., Feed                               swine, and cattle.
 Specialties Co., Inc., Pfizer,
 Inc., PennField Oil Co., and
 VPO, Inc..
Merck Sharp & Dohme Research     Procaine Penicillin  Chickens, turkeys,   Sec. 558.460......  Sec. 558.460.
 Labs., and Solvay Veterinary,                         swine, pheasants,
 Inc.                                                  and quail.
Pfizer, Inc., PennField Oil Co.  Oxytetracycline....  Sec. 558.450.......  Sec. 558.450......  Sec. 558.450.
American Cyanamid Co...........  Chlortetracycline    Cattle.............  Sec. 558.128......  Sec. 558.128.
                                  and sulfamethazine.
Sanofi Animal Health, Inc......  Erythromycin.......  Cattle.............  37 mg per head per  Sec. 558.248.
                                                                            day.
Hoffman-La Roche, Inc..........  Sulfadimethoxine     Chickens and         Sec. 558.575......  Sec. 558.575.
                                  and ormetoprim.      turkeys..
Pfizer, Inc....................  Oxytetracycline and  Chickens, turkeys,   As provided in      As provided in
                                  neomycin.            swine, and calves.   paragraph (g)(2)    paragraph (g)(2)
                                                                            of this section.    of this section.
American Cyanamid Co. and        Chlortetracycline,   Swine..............  ......do..........   Do.
 Pfizer, Inc.                     sulfamethazine,
                                  and penicillin.

[[Page 366]]

 
Boehringer Ingelheim Vetmedica,  Chlortetracycline,   ......do...........  ......do..........   Do.
 Inc..                            sulfathiazole, and
                                  penicillin.
----------------------------------------------------------------------------------------------------------------

    (2) The following is a list of drug combinations permitted when 
prepared from antibacterial Type A articles listed in paragraph (g)(1) 
of this section. Drug combinations listed in subpart B of this part name 
their sponsors and are incorporated herein by reference since they are 
safe and effective by contemporary standards, or such sponsors have been 
notified of any additional safety or efficacy data required on an 
individual basis:

----------------------------------------------------------------------------------------------------------------
                                                                                                Indications for
          Drug sponsor              Type A article          Species            Use levels             use
----------------------------------------------------------------------------------------------------------------
Boehringer Ingelheim Vetmedica,  Chlortetracycline    Swine..............  10 to 50 g/ton and  Enhancement of
 Inc..                            and arsanilic acid.                       0.005 to 0.01       growth and feed
                                                                            percent.            efficiency.
American Cyanamid Co...........  Chlortetracycline    Cattle.............  Sec. 558.128......  Sec. 558.128.
                                  and sulfamethazine.
Pfizer, Inc., PennField Oil      Oxytetracycline and  Chickens...........  50 g/ton and 35 to  Prevention of
 Co., and VPO, Inc.               neomycin base.                            140 g/ton.          diseases from
                                                                                                oxytetracycline
                                                                                                susceptible
                                                                                                organisms during
                                                                                                periods of
                                                                                                stress. As an
                                                                                                aid in the
                                                                                                prevention of
                                                                                                bacterial
                                                                                                enteritis and in
                                                                                                the control of
                                                                                                neomycin-
                                                                                                sensitive
                                                                                                organisms
                                                                                                associated with
                                                                                                bluecomb (mud
                                                                                                fever or
                                                                                                nonspecific
                                                                                                enteritis).
 Do............................  ......do...........  Chickens (first 2    50 to 100 g/ton     Prevention of
                                                       weeks).              and 35 to 140 g/    early chick
                                                                            ton.                mortality due to
                                                                                                oxytetracycline-
                                                                                                susceptible
                                                                                                organisms. As an
                                                                                                aid in the
                                                                                                prevention of
                                                                                                bacterial
                                                                                                enteritis and in
                                                                                                the control of
                                                                                                neomycin-
                                                                                                sensitive
                                                                                                organisms
                                                                                                associated with
                                                                                                bluecomb (mud
                                                                                                fever or
                                                                                                nonspecific
                                                                                                enteritis).
 Do............................  ......do...........  Chickens...........  ......do..........  To extend period
                                                                                                of high egg
                                                                                                production, to
                                                                                                improve feed
                                                                                                efficiency, to
                                                                                                improve egg
                                                                                                production and
                                                                                                feed efficiency
                                                                                                in presence of
                                                                                                disease and at
                                                                                                time of stress.
                                                                                                As an aid in
                                                                                                maintaining and
                                                                                                improving
                                                                                                hatchability
                                                                                                where birds are
                                                                                                suffering stress
                                                                                                from moving,
                                                                                                vaccinations,
                                                                                                culling, extreme
                                                                                                temperature
                                                                                                changes, and
                                                                                                worming; to
                                                                                                improve
                                                                                                livability of
                                                                                                progeny when
                                                                                                losses are due
                                                                                                to
                                                                                                oxytetracycline-
                                                                                                susceptible
                                                                                                organisms, to
                                                                                                improve egg
                                                                                                shell quality,
                                                                                                prevention of
                                                                                                bluecomb (mud
                                                                                                fever or
                                                                                                nonspecific
                                                                                                enteritis). As
                                                                                                an aid in the
                                                                                                prevention of
                                                                                                bacterial
                                                                                                enteritis and in
                                                                                                the control of
                                                                                                nermycon-
                                                                                                sensitive
                                                                                                organisms
                                                                                                associated with
                                                                                                bluecomb (mud
                                                                                                fever or
                                                                                                nonspecific
                                                                                                enteritis).

[[Page 367]]

 
 Do............................  ......do...........  ......do...........  100 to 200 g/ton    Prevention of
                                                                            and 35 to 140 g/    complicated
                                                                            ton.                chronic
                                                                                                respiratory
                                                                                                disease (air-sac
                                                                                                infection) and
                                                                                                control of
                                                                                                complicated
                                                                                                chronic
                                                                                                respiratory
                                                                                                disease by
                                                                                                lowering
                                                                                                mortality and
                                                                                                severity during
                                                                                                outbreaks. As an
                                                                                                aid in the
                                                                                                prevention of
                                                                                                bacterial
                                                                                                enteritis and in
                                                                                                the control of
                                                                                                neomycin-
                                                                                                sensitive
                                                                                                organisms
                                                                                                associated with
                                                                                                bluecomb (mud
                                                                                                fever or
                                                                                                nonspecific
                                                                                                enteritis).
 Do............................  ......do...........  Turkeys............  50 g/ton and 35 to  As an aid in the
                                                                            140 g/ton.          prevention of
                                                                                                disease from
                                                                                                oxytetracycline
                                                                                                susceptible
                                                                                                organisms during
                                                                                                periods of
                                                                                                stress. As an
                                                                                                aid in the
                                                                                                prevention of
                                                                                                bacterial
                                                                                                enteritis and in
                                                                                                the control of
                                                                                                neomycin-
                                                                                                sensitive
                                                                                                organisms
                                                                                                associated with
                                                                                                bluecomb (mud
                                                                                                fever or
                                                                                                nonspecific
                                                                                                enteritis).
 Do............................  ......do...........  ......do...........  50 to 100 g/ton     To extend periord
                                                                            and 35 to 140 g/    of high egg
                                                                            ton.                production, to
                                                                                                improve egg
                                                                                                production, to
                                                                                                improve feed
                                                                                                efficiency, to
                                                                                                improve
                                                                                                fertility, to
                                                                                                improve egg
                                                                                                production and
                                                                                                feed efficiency
                                                                                                in presence of
                                                                                                disease and time
                                                                                                of stress; as an
                                                                                                aid in
                                                                                                maintaining and
                                                                                                improving
                                                                                                hatchability
                                                                                                where birds are
                                                                                                suffering from
                                                                                                stress,
                                                                                                exposure,
                                                                                                moving,
                                                                                                vaccination,
                                                                                                culling, extreme
                                                                                                losses due to
                                                                                                oxytetracycline-
                                                                                                susceptible
                                                                                                organisms, and
                                                                                                to improve egg
                                                                                                shell quality
                                                                                                prevention of
                                                                                                hexamitiasis. As
                                                                                                an aid in the
                                                                                                prevention of
                                                                                                bacterial
                                                                                                enteritis and in
                                                                                                the control of
                                                                                                neomycin-
                                                                                                sensitive
                                                                                                organisms
                                                                                                associated with
                                                                                                bluecomb (mud
                                                                                                fever or
                                                                                                nonspecific
                                                                                                enteritis).
 Do............................  ......do...........  Turkeys (first 4     ......do..........  As an aid in the
                                                       weeks).                                  prevention of
                                                                                                early poult
                                                                                                mortality due to
                                                                                                oxytetracycline-
                                                                                                susceptible
                                                                                                organisms. As an
                                                                                                aid in the
                                                                                                prevention of
                                                                                                bacterial
                                                                                                enteritis and in
                                                                                                the control of
                                                                                                neomycin-
                                                                                                sensitive
                                                                                                organisms
                                                                                                associated with
                                                                                                bluecomb (mud
                                                                                                fever or
                                                                                                nonspecific
                                                                                                enteritis).
 Do............................  ......do...........  ......do...........  100 to 150 g/ton    As an aid in
                                                                            and 35 to 105 g/    reducing
                                                                            ton.                mortality in
                                                                                                birds which have
                                                                                                suffered an
                                                                                                attack of air-
                                                                                                sacculitis (it
                                                                                                is recommended,
                                                                                                wherever
                                                                                                possible, to
                                                                                                feed from time
                                                                                                of attack to
                                                                                                marketing).
 Do............................  ......do...........  Turkeys............  ......do..........  As an aid in the
                                                                                                prevention of
                                                                                                bacterial
                                                                                                enteritis and in
                                                                                                the control of
                                                                                                neomycin-
                                                                                                sensitive
                                                                                                organisms
                                                                                                associated with
                                                                                                bluecomb (mud
                                                                                                fever or
                                                                                                nonspecific
                                                                                                enteritis).

[[Page 368]]

 
 Do............................  ......do...........  ......do...........  100 to 200 g/ton    Control of
                                                                            and 35 to 140 g/    bluecomb (mud
                                                                            ton.                fever or
                                                                                                nonspecific
                                                                                                enteritis),
                                                                                                infectious
                                                                                                sinusitis and
                                                                                                hexamitiasis,
                                                                                                prevention of
                                                                                                infectious
                                                                                                synovitis. As an
                                                                                                aid in the
                                                                                                prevention of
                                                                                                bacterial
                                                                                                enteritis and in
                                                                                                the control of
                                                                                                neomycin-
                                                                                                sensitive
                                                                                                organisms
                                                                                                associated with
                                                                                                bluecomb (mud
                                                                                                fever or
                                                                                                nonspecific
                                                                                                enteritis).
 Do............................  ......do...........  ......do...........  200 g/ton and 70    Control of
                                                                            to 140 g/ton.       infectious
                                                                                                synovitis. For
                                                                                                the treatment of
                                                                                                bacterial
                                                                                                enteritis and
                                                                                                bluecomb (mud
                                                                                                fever or
                                                                                                nonspecific
                                                                                                enteritis).
 Do............................  ......do...........  Swine..............  50 g/ton and 35 to  As an aid in the
                                                                            140 g/ton.          prevention of
                                                                                                bacterial
                                                                                                enteritis
                                                                                                (scours), baby
                                                                                                pig diarrhea (in
                                                                                                baby pigs only),
                                                                                                vibrionic
                                                                                                dysentery,
                                                                                                bloody
                                                                                                dysentery, and
                                                                                                salmonellosis
                                                                                                (necro or
                                                                                                necrotic
                                                                                                enteritis).
 Do............................  ......do...........  ......do...........  50 to 150 g/ton     As an aid in the
                                                                            and 70 to 140 g/    maintenance of
                                                                            ton.                weight gains and
                                                                                                feed consumption
                                                                                                in the presence
                                                                                                of atrophic
                                                                                                rhinitis. As an
                                                                                                aid in the
                                                                                                treatment of
                                                                                                bacterial
                                                                                                enteritis.
 Do............................  ......do...........  Calves.............  50 g/ton and 35 to  As an aid in the
                                                                            140 g/ton.          prevention of
                                                                                                bacterial
                                                                                                enteritis
                                                                                                (scours).
 Do............................  ......do...........  ......do...........  100 g/ton and 70    As an aid in the
                                                                            to 140 g/ton.       treatment of
                                                                                                bacterial
                                                                                                enteritis
                                                                                                (scours).
 Do............................  ......do...........  ......do...........  8 to 100 mg/gal     As an aid in the
                                                                            and 100 to 200 mg/  prevention of
                                                                            gal reconstituted   bacterial
                                                                            milk replacer.      diarrhea
                                                                                                (scours).
 Do............................  ......do...........  ......do...........  40 to 200 mg/gal    As an aid in the
                                                                            and 200 to 400 mg/  treatment of
                                                                            gal reconstituted   bacterial
                                                                            milk replacer.      diarrhea
                                                                                                (scours).
The Upjohn Co..................  Lincomycin,          Chickens...........  Secs. 558.58 and    Secs. 558.58 and
                                  amprolium, and                            558.325.            558.325.
                                  ethopabate.
 Do............................  Lincomycin and       ......do...........  Secs. 558.325 and   Secs. 558.325 and
                                  zoalene.                                  558.680.            558.680.
 Do............................  Lincomycin,          ......do...........  Secs. 558.58,       Secs. 558.58,
                                  amprolium,                                558.325, and        558.325, and
                                  ethopabate, and                           558.530.            558.530.
                                  roxarsone.
 Do............................  Lincomycin,          ......do...........  Secs. 558.325,      Secs. 558.325,
                                  monensin, and                             558.355, and        558.355, and
                                  roxarsone.                                558.530.            558.530.
 Do............................  Nicarbazin and       Chickens...........  0.01 to 0.02         Do.
                                  procaine                                  percent and 2.4
                                  penicillin.                               to 50 g/ton.
 Do............................  Nicarbazin and       .....do............  0.01 to 0.02         Do.
                                  bacitracin                                percent and 4 to
                                  methylene                                 50 g/ton.
                                  disalicylate.
 Do............................  Nicarbazin,          .....do............  0.01 to 0.02         Do.
                                  bacitracin                                percent, 4 to 50
                                  methylene                                 g/ton, and 0.0025
                                  disalicylate, and                         to 0.005 percent.
                                  roxarsone.
 Do............................  Nicarbazin,          .....do............  0.01 to 0.02         Do.
                                  procaine                                  percent, 2.4 to
                                  penicillin, and                           50 g/ton, and
                                  roxarsone.                                0.0025 to 0.025
                                                                            percent.

[[Page 369]]

 
 Do............................  Amprolium and        Chickens and         0.0125 to 0.025     Secs. 558.55 and
                                  bacitracin           turkeys.             percent and 4 to    558.76.
                                  methylene                                 50 g/ton.
                                  disalicylate.
 Do............................  Amprolium,           Chickens...........  0.0125 to 0.025     Secs. 558.58 and
                                  ethopabate, and                           percent, 0.0004     558.76.
                                  bacitracin                                percent, and 4 to
                                  methylene                                 50 g/ton.
                                  disalicylate.
 Do............................  Amprolium,           .....do............  0.0125 to 0.025     Secs. 558.58,
                                  ethopabate,                               percent, 0.0004     558.76, and
                                  bacitracin                                percent, 4 to 50    558.530.
                                  methylene                                 g/ton, and 0.0025
                                  disalicylate, and                         to 0.005 percent.
                                  roxarsone.
 Do............................  Amprolium and        Chickens and         0.004 to 0.025      Secs. 558.55 and
                                  procaine             turkeys.             percent and 2.4     558.460.
                                  penicillin.                               to 50 g/ton.
 Do............................  Amprolium, procaine  Chickens...........  0.004 to 0.025      Secs. 558.55,
                                  penicillin, and                           percent, 2.4 to     558.460, and
                                  roxarsone.                                50 g/ton, and       558.530.
                                                                            0.0025 to 0.005
                                                                            percent.
 Do............................  Amprolium,           ......do...........  0.0125 to 0.025     Secs. 558.58 and
                                  ethopabate,                               percent, 0.0004     558.460.
                                  procaine                                  percent, 2.4 to
                                  penicillin, and                           50 g/ton, and 4.6
                                  erythromycin.                             to 18.5 g/ton.
 Do............................  Amprolium and        ......do...........  0.0125 to 0.025     Sec. 558.55.
                                  erythromycin.                             percent and 4.6
                                                                            to 18.5 g/ton.
 Do............................  Amprolium and        ......do...........  0.0125 to 0.025     Sec. 558.58.
                                  ethopabate.                               percent and
                                                                            0.0004 percent.
 Do............................  Amprolium,           ......do...........  0.0125 to 0.025     Sec. 558.55.
                                  arsanilic acid,                           percent, 0.01
                                  and erythromycin.                         percent, and 4.6
                                                                            to 18.5 g/ton.
 Do............................  Amprolium,           ......do...........  0.0125 to 0.025     Sec. 558.58.
                                  arsanilic acid,                           percent, 0.01
                                  and ethopabate.                           percent, and
                                                                            0.0004 percent.
 Do............................  Amprolium,           ......do...........  0.0125 percent,      Do.
                                  ethopabate, and                           0.004 percent,
                                  bacitracin                                and 4 to 50 g/ton.
                                  methylene
                                  disalicylate.
 Do............................  Amprolium,           ......do...........  0.0125 percent,      Do.
                                  ethopabate,                               0.004 percent, 5
                                  bacitracin                                to 35 g/ton, and
                                  methylene                                 0.00375 percent.
                                  disalicylate, and
                                  roxarsone.
Pitman-Moore, Inc..............  Bacitracin zinc,     ......do...........  4 to 50 g/ton,      Prevention of
                                  amprolium, and                            0.0125 to 0.025     coccidiosis.
                                  ethopabate.                               percent, and        Growth promotion
                                                                            0.0004 percent.     and feed
                                                                                                efficiency.
                                                                                                Sec.558.78.
 Do............................  Bacitracin zinc,     ......do...........  4 to 50 g/ton,      Prevention of
                                  amprolium,                                0.0125 to 0.025     coccidiosis.
                                  ethopabate, and                           percent, 0.0004     Growth promotion
                                  roxarsone.                                percent, and        and feed
                                                                            0.0025 to 0.005     efficiency.
                                                                            percent.            Improving
                                                                                                pigmentation.
                                                                                                Sec. 558.78.
 Do............................  Bacitracin zinc and  Swine..............  10 to 50 g/ton and  Increased rate of
                                  arsanilic acid.                           0.005 to 0.01       weight gain and
                                                                            percent.            improved feed
                                                                                                efficiency.
Merck Sharp & Dohme Research     Amprolium,           Chickens...........  0.125 to 0.025      Secs. 558.58,
 Labs.                            ethopabate,                               percent, 0.0004     558.460 and
                                  procaine                                  percent, 2.4 to     558.530.
                                  penicillin, and                           50 g/ton, and
                                  roxarsone.                                0.0025 to 0.005
                                                                            percent.

[[Page 370]]

 
A. L. Laboratories, Inc........  Zoalene and          Chickens...........  0.0125 percent and  Sec. 558.680.
                                  bacitracin                                4 to 50 g/ton.
                                  methylene
                                  disalicylate.
 Do............................  Zoalene, roxarsone,  ......do...........  0.0125 percent,      Do.
                                  and bacitracin                            0.005 percent,
                                  methylene                                 and 4 to 50 g/ton.
                                  disalicylate.
 Do............................  Zoalene and          ......do...........  0.0125 percent and   Do.
                                  bacitracin zinc.                          4 to 50 g/ton.
 Do............................  Zoalene, roxarsone,  ......do...........  0.0125 percent,      Do.
                                  and bacitracin                            0.0025 to 0.005
                                  zinc.                                     percent, and 4 to
                                                                            50 g/ton.
 Do............................  Zoalene and          ......do...........  0.0125 percent and   Do.
                                  penicillin.                               2.4 to 50 g/ton.
 Do............................  Zoalene, roxarsone,  ......do...........  0.0125 percent,      Do.
                                  and penicillin.                           0.0025 to 0.005
                                                                            percent, and 2.4
                                                                            to 50 g/ton.
 Do............................  Zoalene, arsanilic   ......do...........  0.0125 percent,      Do.
                                  acid, and                                 0.01 percent, and
                                  bacitracin                                4 to 50 g/ton.
                                  methylene
                                  disalicylate or
                                  bacitracin zinc.
 Do............................  Zoalene, arsanilic   ......do...........  0.0125 percent,      Do.
                                  acid, and                                 0.01 percent, and
                                  penicillin.                               2.4 to 50 g/ton.
 Do............................  Zoalene, and         ......do...........  0.004 to 0.0125      Do.
                                  bacitracin                                percent and 4 to
                                  methylene                                 50 g/ton.
                                  disalicylate.
 Do............................  Zoalene, roxarsone,  ......do...........  0.004 to 0.0125      Do.
                                  and bacitracin                            percent, 0.0025
                                  methylene                                 to 0.005 percent,
                                  disalicylate.                             and 4 to 50 g/ton.
Whitmoyer Labs, Inc............  Carbarsone and       Turkeys............  Sec. 558.120......  Sec. 558.120.
                                  bacitracin.
Elanco Products Co.............  Hygromycin B and     Chickens...........  8 to 12 g/ton and   Sec. 558.274.
                                  tylosin.                                  4 to 50 g/ton.
 Do............................  ......do...........  Swine..............  12 g/ton and 10 to   Do.
                                                                            100 g/ton.
A. L. Laboratories, Inc........  Nitarsone and        Turkeys............  0.01875 percent, 4  As an aid in the
                                  bacitracin zinc.                          to 50 g/ton.        prevention of
                                                                                                blackhead. To
                                                                                                increase rate of
                                                                                                weight gain and
                                                                                                improve feed
                                                                                                efficiency.
----------------------------------------------------------------------------------------------------------------


[51 FR 8811, Mar. 14, 1986; 51 FR 11014, Apr. 1, 1986, as amended at 51 
FR 28547, Aug. 8, 1986; 53 FR 20843, June 7, 1988; 54 FR 37098, Sept. 7, 
1989; 54 FR 51386, Dec. 15, 1989; 55 FR 8460, 8462, Mar. 8, 1990; 56 FR 
41912, Aug. 23, 1991; 56 FR 64702, Dec. 12, 1991; 57 FR 6476, Feb. 25, 
1992; 57 FR 8577, Mar. 11, 1992; 57 FR 14639, Apr. 22, 1992; 58 FR 
17515, Apr. 5, 1993; 58 FR 30119, May 26, 1993; 61 FR 51589, Oct. 3, 
1996; 64 FR 992, Jan. 7, 1999; 64 FR 37673, July 13, 1999]



      Subpart B--Specific New Animal Drugs for Use in Animal Feeds



Sec.  558.35  Aklomide.

    (a) Approvals. Type A medicated articles: to 053501 in Sec.  
510.600(c) of this chapter, as follows:
    (1) 50 percent aklomide.
    (2) 20 percent sulfanitran and 25 percent aklomide.
    (3) 25 percent aklomide, 20 percent sulfanitran, and 5 percent 
roxarsone.
    (4) 50 percent aklomide and 10 percent roxarsone.
    (b) Related tolerances. See Sec.  556.30 of this chapter.
    (c) Conditions of use. It is used in feed for chickens as follows:
    (1) Amount per ton. Aklomide, 227 grams (0.025 percent).

[[Page 371]]

    (i) Indications for use. As an aid in the prevention of coccidiosis 
caused by E. tenella and E. necatrix.
    (ii) Limitations. Not to be fed to birds laying eggs for human 
consumption.
    (2) Amount per ton. Aklomide, 227 grams (0.025 percent) combined 
with sulfanitran, 181.6 grams (0.02 percent).
    (i) Indications for use. As an aid in the prevention of coccidiosis 
caused by E. tenella, E. necatrix, and E. acervulina.
    (ii) Limitations. Not to be fed to laying chickens; withdraw 5 days 
before slaughter.
    (3) Amount per ton. Aklomide, 227 grams (0.025 percent) combined 
with sulfanitran, 181.6 grams (0.02 percent) + roxarsone, 22.7-45.4 
grams (0.0025-0.005 percent).
    (i) Indications for use. As an aid in the prevention of coccidiosis 
caused by E. tenella, E. necatrix, and E. acervulina; growth promition 
and feed efficiency; improving pigmentation.
    (ii) Limitations. Not to be fed to laying chickens; withdraw 5 days 
before slaughter; as sole source of organic arsenic; chickens should 
have access to drinking water at all times.
    (4) Amount per ton. Aklomide, 227 grams (0.025 percent) combined 
with roxarsone, 22.7-45.4 grams (0.0025-0.005 percent).
    (i) Indications for use. As an aid in the prevention of coccidiosis 
caused by E. tenella, and E. necatrix; growth promotion and feed 
efficiency; improving pigmentation.
    (ii) Limitations. Not to be fed to birds laying eggs for human 
consumption; withdraw 5 days before slaughter; as sole source of organic 
arsenic; chickens should have access to drinking water at all times.

[40 FR 13959, Mar. 27, 1975, as amended at 41 FR 8312, Feb. 25, 1976; 51 
FR 7395, Mar. 3, 1986; 55 FR 8460, Mar. 8, 1990]



Sec.  558.55  Amprolium.

    (a) Approvals. Type A medicated articles: 25 percent to 050604 in 
Sec.  510.600(c) of this chapter for use as in paragraph (d) of this 
section.
    (b) Special considerations. Do not use in Type B or Type C medicated 
feeds containing bentonite.
    (c) Related tolerances. See Sec.  556.50 of this chapter.
    (d) Conditions of use--(1) Calves. It is top-dressed on or 
thoroughly mixed in the daily feed ration as follows:
    (i) Amount. 227 milligrams per 100 pounds (5 milligrams per 
kilogram) body weight per day.
    (a) Indications for use. As an aid in the prevention of coccidiosis 
caused by Eimeria bovis and E. zurnii.
    (b) Limitations. Administer from a Type B feed containing from 0.05 
to 1.25 percent amprolium with the usual amount of feed consumed in 1 
day; feed for 21 days during periods of exposure or when experience 
indicates that coccidiosis is likely to be a hazard; withdraw 24 hours 
before slaughter; as sole source of amprolium.
    (ii) Amount. 454 milligrams per 100 pounds (10 milligrams per 
kilogram) body weight per day.
    (a) Indications for use. As an aid in the treatment of coccidiosis 
caused by Eimeria bovis and E. zurnii.
    (b) Limitations. Administer from a Type B feed containing from 0.05 
to 1.25 percent amprolium with the usual amount of feed consumed in 1 
day; feed for 5 days; for a satisfactory diagnosis, a microscopic 
examination of the feces should be done by a veterinarian or diagnostic 
laboratory before treatment; when treating outbreaks, the drug should be 
administered promptly after diagnosis is determined; withdraw 24 hours 
before slaughter; as sole source of amprolium.
    (2) Chickens and turkeys. It is used as follows:

----------------------------------------------------------------------------------------------------------------
                               Combination in grams per
 Amprolium in grams per ton              ton                Indications for use       Limitations       Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 36.3 to 113.5 (0.004%    ...........................  Replacement chickens;     Feed as follows--
 to 0.0125%).                                              development of active
                                                           immunity to
                                                           coccidiosis.
----------------------------------------------------------------------------------------------------------------


[[Page 372]]


 
                                                              Up to 5 weeks of    From 5 to 8    Over 8 weeks of
                                        Growing conditions           age          weeks of age         age
----------------------------------------------------------------------------------------------------------------
                                                                     Amprolium        Amprolium        Amprolium
                                                                 grams per ton    grams per ton    grams per ton
 
                                      Severe exposure to       113.5 (0.0125%)       72.6-113.5       36.3-113.5
                                       coccidiosis.                                    (0.008%-         (0.004%-
                                                                                       0.0125%)         0.0125%)
                                      Moderate exposure to          72.6-113.5       54.5-113.5       36.3-113.5
                                       coccidiosis.                   (0.008%-         (0.006%-         (0.004%-
                                                                      0.0125%)         0.0125%)         0.0125%)
                                      Slight exposure to            36.3-113.5       36.3-113.5       36.3-113.5
                                       coccidiosis.                   (0.004%-         (0.004%-         (0.004%-
                                                                      0.0125%)         0.0125%)         0.0125%)
                                     -------------------------


----------------------------------------------------------------------------------------------------------------
                                Combination in grams
 Amprolium in grams per ton           per ton            Indications for use         Limitations        Sponsor
----------------------------------------------------------------------------------------------------------------
                              Arsanilate sodium 90     Replacement chickens;   Withdraw 5 d before
                               (0.01%).                 development of active   slaughter; as sole
                                                        immunity to             source of organic
                                                        coccidiosis; growth     arsenic; feed
                                                        promotion and feed      according to subtable
                                                        efficiency; improving   in item (i).
                                                        pigmentation.
 
 
                              Arsanilic acid 90        Replacement chickens;   Withdraw 5 d before
                               (0.01%).                 development of active   slaughter; as sole
                                                        immunity to             source of organic
                                                        coccidiosis; growth     arsenic; feed
                                                        promotion and feed      according to subtable
                                                        efficiency; improving   in item (i).
                                                        pigmentation.
 
 
                              Arsanilic acid 90        Replacement chickens;   Withdraw 5 d before
                               (0.01%) plus             development of active   slaughter; as sole
                               erythromycin 4.6 to      immunity to             source of organic
                               18.5.                    coccidiosis; growth     arsenic. Feed
                                                        promotion and feed      according to subtable
                                                        efficiency; improving   in item (i).
                                                        pigmentation.
                              Arsanilic acid 90        1. Replacement          Feed for 2 d before
                               (0.01%) plus             chickens; development   stress and 3 to 6 d
                               erythromycin 92.5.       of active immunity to   after stress;
                                                        coccidiosis; growth     withdraw 5 d before
                                                        promotion and feed      slaughter; as sole
                                                        efficiency; improving   source of organic
                                                        pigmentation; as an     arsenic. Feed
                                                        aid in the prevention   according to subtable
                                                        of chronic              in item (i).
                                                        respiratory disease
                                                        during periods of
                                                        stress.
                                                       2. Replacement          Feed for 7 to 14 d;
                                                        chickens; development   withdraw 5 d before
                                                        of active immunity to   slaughter; as sole
                                                        coccidiosis; growth     source of organic
                                                        promotion and feed      arsenic. Feed
                                                        efficiency; improving   according to subtable
                                                        pigmentation; as an     in item (i).
                                                        aid in the prevention
                                                        of infectious coryza.
(i) 36.3 to 113.5 (0.004% to  Arsanilic acid 90        Replacement chickens;   Feed for 5 to 8 d; do   .........
 0.0125%).                     (0.01%) plus             development of active   not use in birds
                               erythromycin 185.        immunity to             producing eggs for
                                                        coccidiosis; growth     food purposes;
                                                        promotion and feed      withdraw 5 d before
                                                        efficiency; improving   slaughter; as sole
                                                        pigmentation; as an     source of organic
                                                        aid in the prevention   arsenic. Feed
                                                        and reduction of        according to subtable
                                                        lesions and in          in item (i).
                                                        lowering severity of
                                                        chronic respiratory
                                                        disease.
                              Bacitracin 100 to 200..  Replacement chickens;   As bacitracin           .........
                                                        development of active   methylene
                                                        immunity to             disalicylate or
                                                        coccidiosis;            bacitracin zinc. Feed
                                                        treatment of chronic    according to subtable
                                                        respiratory disease     in item (i).
                                                        (air-sac infection)
                                                        and blue comb
                                                        (nonspecific
                                                        infectious enteritis).
                              Bacitracin methylene     Replacement chickens;   Feed according to          046573
                               disalicylate 4 to 50..   development of active   subtable in item (i);
                                                        immunity to             bacitracin methylene
                                                        coccidiosis,            disalicylate as
                                                        increased rate of       provided by 046573 in
                                                        weight gain, and        Sec.   510.600(c) of
                                                        improved feed           this chapter..
                                                        efficiency..

[[Page 373]]

 
                              Bacitracin methylene     Replacement chickens;   Feed according to          046573
                               disalicylate 50 plus     development of active   subtable in entry
                               roxarsone 22.7 to        immunity to             (i); bacitracin
                               45.4..                   coccidiosis; as an      methylene
                                                        aid in the control of   disalicylate and
                                                        necrotic enteritis      roxarsone as provided
                                                        caused or complicated   by 046573 in Sec.
                                                        by Clostridium spp.     510.600(c) of this
                                                        or other organisms      chapter..
                                                        susceptible to
                                                        bacitracin; increased
                                                        rate of weight gain,
                                                        improved feed
                                                        efficiency, and
                                                        improved
                                                        pigmentation..
                              Chlortetracycline 100    Chickens; development   Do not feed to          .........
                               to 200.                  of active immunity to   chickens producing
                                                        coccidiosis; control    eggs for human
                                                        of infectious           consumption. Feed for
                                                        synovitis caused by     7 to 14 d.
                                                        Mycoplasma synoviae
                                                        susceptible to
                                                        chlortetracycline.
                              Chlortetracycline 200    Chickens; development   Do not feed to          .........
                               to 400.                  of active immunity to   chickens producing
                                                        coccidiosis; control    eggs for human
                                                        of chronic              consumption. Feed for
                                                        respiratory disease     7 to 14 d.
                                                        (CRD) and air sac
                                                        infection caused by
                                                        M. gallisepticum and
                                                        E. coli susceptible
                                                        to chlortetracycline.
                              Erythromycin 4.6 to      Replacement chickens;   As erythromycin         .........
                               18.5.                    development of active   thiocyanate. Feed
                                                        immunity to             according to subtable
                                                        coccidiosis; growth     in item (i).
                                                        promotion and feed
                                                        efficiency.
                              Erythromycin 92.5......  1. Replacement          Feed for 7 to 14 d;     .........
                                                        chickens; development   withdraw 24 h before
                                                        of active immunity to   slaughter. Feed
                                                        coccidiosis; as an      according to subtable
                                                        aid in the prevention   in item (i).
                                                        of infectious coryza.
                                                       2. Replacement          Feed for 2 d before     .........
                                                        chickens; development   stress and 3 to 6 d
                                                        of active immunity to   after stress;
                                                        coccidiosis; as an      withdraw 24 h before
                                                        aid in the prevention   slaughter. Feed
                                                        of chronic              according to subtable
                                                        respiratory disease     in item (i).
                                                        during periods of
                                                        stress.
                              Erythromycin 185.......  Replacement chickens;   Feed for 5 to 8 d; do   .........
                                                        development of active   not use in birds
                                                        immunity to             producing eggs for
                                                        coccidiosis; as an      food purposes;
                                                        aid in the prevention   withdraw 48 h before
                                                        and reduction of        slaughter. Feed
                                                        lesions and in          according to subtable
                                                        lowering severity of    in item (i).
                                                        chronic respiratory
                                                        disease.
                              Hygromycin B 8 to 12...  Replacement chickens;   Feed according to       .........
                                                        development of active   subtable in item (i).
                                                        immunity to
                                                        coccidiosis; control
                                                        of infestation of
                                                        large round worms
                                                        (Ascaris galli),
                                                        cecal worms
                                                        (Heterakis gallinae),
                                                        and capillary worms
                                                        (Capillaria
                                                        obsignata).
                              Penicillin 2.4 to 50...  Replacement chickens;   As procaine             .........
                                                        development of active   penicillin. Feed
                                                        immunity to             according to subtable
                                                        coccidiosis; growth     in item (i).
                                                        promotion and feed
                                                        efficiency.
                              Roxarsone 22.7 to 45.4   Replacement chickens;   Withdraw 5 d before     .........
                               (0.0025% to 0.005%).     development of active   slaughter; as sole
                                                        immunity to             source of organic
                                                        coccidiosis; growth     arsenic. Feed
                                                        promotion, and feed     according to subtable
                                                        efficiency; improving   in item (i).
                                                        pigmentation.
(ii) 72.6 to 113.5 (0.008%    .......................  Broiler chickens;       Withdraw 5 d before     .........
 to 0.0125%).                                           prevention of           slaughter; as sole
                                                        coccidiosis caused by   source of organic
                                                        Eimeria tenella only.   arsenic. Feed
                                                                                according to subtable
                                                                                in item (i).
                              Arsanilate sodium 90     Broiler chickens;       Withdraw 5 d before     .........
                               (0.01%).                 prevention of           slaughter; as sole
                                                        coccidiosis caused by   source of organic
                                                        E. tenella only;        arsenic.
                                                        growth promotion and
                                                        feed efficiency;
                                                        improving
                                                        pigmentation.

[[Page 374]]

 
                              Arsanilic acid 90        ......do..............  ......do..............  .........
                               (0.01%).
                              Bacitracin 100 to 200..  Broiler chickens;       As bacitracin           .........
                                                        prevention of           methylene
                                                        coccidiosis caused by   disalicylate, or zinc
                                                        E. tenella only;        bacitracin.
                                                        treatment of chronic
                                                        respiratory disease
                                                        (air-sac infection)
                                                        and blue comb
                                                        (nonspecific
                                                        infectious enteritis).
                              Chlortetracycline 100    Chickens; prevention    Do not feed to          .........
                               to 200.                  of coccidiosis caused   chickens producing
                                                        by E. tenella only;     eggs for human
                                                        control of infectious   consumption. Feed for
                                                        synovitis caused by     7 to 14 d.
                                                        M. synoviae
                                                        susceptible to
                                                        chlortetracycline.
                              Chlortetracycline 200    Chickens; prevention    Do not feed to          .........
                               to 400.                  of coccidiosis caused   chickens producing
                                                        by E. tenella only;     eggs for human
                                                        control of chronic      consumption. Feed for
                                                        respiratory disease     7 to 14 d.
                                                        (CRD) and air sac
                                                        infection caused by
                                                        M. gallisepticum and
                                                        E. coli susceptible
                                                        to chlortetracycline.
                              Hygromycin B 8 to 12...  Broiler chickens;       Feed according to       .........
                                                        prevention of           subtable in item (i).
                                                        coccidiosis caused by
                                                        Eimeria tenella only;
                                                        control of
                                                        infestation of large
                                                        round worms
                                                        (Heterakis gallinae),
                                                        and capillary worms
                                                        (Capillaria
                                                        obsignata).
                              Penicillin 2.4 to 50...  Broiler chickens;       As procaine penicillin  .........
                                                        prevention of
                                                        coccidiosis caused by
                                                        E. tenella only;
                                                        growth promotion and
                                                        feed efficiency.
                              Roxarsone 22.7 to 45.4   Broiler chickens;       Withdraw 5 d before     .........
                               (0.0025% to 0.005%).     prevention of           slaughter; as sole
                                                        coccidiosis caused by   source of organic
                                                        E. tenella only;        arsenic.
                                                        growth promotion and
                                                        feed efficiency;
                                                        improving
                                                        pigmentation.
(iii) 113.5 (0.0125%).......  .......................  1. Laying chickens;     ......................  .........
                                                        prevention of
                                                        coccidiosis.
                                                       2. Laying chickens;     For moderate outbreaks  .........
                                                        treatment of            of coccidiosis;
                                                        coccidiosis.            administer for 2
                                                                                weeks.
                              Bambermycins 1 to 3      Broiler chickens; as    Feed continuously as    .........
                               plus roxarsone 22.8 to   an aid in the           the sole ration; as
                               34.1 (0.0025% to         prevention of           sole source of
                               0.00375%).               coccidiosis; for        amprolium and organic
                                                        increased rate of       arsenic; roxarsone as
                                                        weight gain, improved   provided by No.
                                                        feed efficiency, and    053501 in Sec.
                                                        improved pigmentation.  510.600(c) of this
                                                                                chapter, bambermycins
                                                                                by No. 057926;
                                                                                withdraw 5 d before
                                                                                slaughter.
                              Bambermycins 1 to 4....  Growing turkeys;        Feed continuously as       057926
                                                        prevention of           the sole source of
                                                        coccidiosis;            amprolium;
                                                        increased rate of       bambermycins as
                                                        weight gain and         provided by No.
                                                        improved feed           057926 in Sec.
                                                        efficiency.             510.600(c) of this
                                                                                chapter.
(iv) 113.5 to 227 (0.0125%    .......................  1. Broiler chickens     ......................  .........
 to 0.025%).                                            and replacement
                                                        chickens where
                                                        immunity to
                                                        coccidiosis is not
                                                        desired; prevention
                                                        of coccidiosis.
                                                       2. Turkeys; prevention  ......................  .........
                                                        of coccidiosis.
                              Arsanilate sodium 90     1. Broiler chickens     Withdraw 5 d before     .........
                               (0.01%).                 and replacement         slaughter; as sole
                                                        chickens where          source of organic
                                                        immunity to             arsenic.
                                                        coccidiosis is not
                                                        desired; prevention
                                                        of coccidiosis;
                                                        growth promotion and
                                                        feed efficiency;
                                                        improving
                                                        pigmentation.

[[Page 375]]

 
                                                       2. Turkeys; prevention  ......do..............  .........
                                                        of coccidiosis;
                                                        growth promotion and
                                                        feed efficiency;
                                                        improving
                                                        pigmentation.
                              Arsanilic acid 90        1. Broiler chickens     ......do..............  .........
                               (0.01%).                 and replacement
                                                        chickens where
                                                        immunity to
                                                        coccidiosis is not
                                                        desired; prevention
                                                        of coccidiosis;
                                                        growth promotion and
                                                        feed efficiency;
                                                        improving
                                                        pigmentation.
                                                       2. Turkeys; prevention  ......do..............  .........
                                                        of coccidiosis;
                                                        growth promotion and
                                                        feed efficiency;
                                                        improving
                                                        pigmentation.
                              Arsanilic acid 90        1. Broiler chickens     Feed for 2 d before     .........
                               (0.01%) plus             and replacement         stress and 3 to 6 d
                               erythromycin 92.5.       chickens where          after stress;
                                                        immunity to             withdraw 5 d before
                                                        coccidiosis is not      slaughter; as sole
                                                        desired; prevention     source of organic
                                                        of coccidiosis;         arsenic.
                                                        growth promotion and
                                                        feed efficiency;
                                                        improving
                                                        pigmentation; as an
                                                        aid in the prevention
                                                        of chronic
                                                        respiratory disease
                                                        during periods of
                                                        stress.
                                                       2. Broiler chickens     Feed for 7 to 14 d;     .........
                                                        and replacement         withdraw 5 d before
                                                        chickens where          slaughter; as sole
                                                        immunity to             source of organic
                                                        coccidiosis is not      arsenic.
                                                        desired; prevention
                                                        of coccidiosis;
                                                        growth promotion and
                                                        feed efficiency;
                                                        improving
                                                        pigmentation; as an
                                                        aid in the prevention
                                                        of infectious coryza.
                              Arsanilic acid 90        Broiler chickens and    Feed for 5 to 8 d; do   .........
                               (0.01%) plus             replacement chickens    not use in birds
                               erythromycin 185.        where immunity to       producing eggs for
                                                        coccidiosis is not      food purposes;
                                                        desired; prevention     withdraw 5 d before
                                                        of coccidiosis;         slaughter; as sole
                                                        growth promotion and    source of organic
                                                        feed efficiency;        arsenic.
                                                        improving
                                                        pigmentation; as an
                                                        aid in the prevention
                                                        and reduction of
                                                        lesions and in
                                                        lowering severity of
                                                        chronic respiratory
                                                        disease.
                              Arsanilic acid 90        Broiler chickens and    Withdraw 5 d before     .........
                               (0.01%) plus             replacement chickens    slaughter; as sole
                               erythromycin 4.6 to      where immunity to       source of organic
                               18.5.                    coccidiosis is not      arsenic.
                                                        desired; prevention
                                                        of coccidiosis;
                                                        growth promotion and
                                                        feed efficiency;
                                                        improved pigmentation.
                              Bacitracin 4 to 50.....  1. Broiler chickens     As bacitracin                 \1\
                                                        and replacement         methylene                 012769
                                                        chickens where          disalicylate or
                                                        immunity to             bacitracin zinc.
                                                        coccidiosis is not
                                                        desired; prevention
                                                        of coccidiosis;
                                                        growth promotion and
                                                        feed efficiency.
                                                       2. Turkeys; prevention  ......do..............  .........
                                                        of coccidiosis;
                                                        growth promotion and
                                                        feed efficiency.
                              Bacitracin 100 to 200..  1. Broiler chickens     ......do..............  .........
                                                        and replacement
                                                        chickens where
                                                        immunity to
                                                        coccidiosis is not
                                                        desired; prevention
                                                        of coccidiosis;
                                                        treatment of chronic
                                                        respiratory disease
                                                        (air-sac infection),
                                                        blue comb
                                                        (nonspecific
                                                        infectious enteritis).

[[Page 376]]

 
                                                       2. Broiler chickens     As bacitracin zinc....  .........
                                                        and replacement
                                                        chickens where
                                                        immunity to
                                                        coccidiosis is not
                                                        desired; prevention
                                                        of coccidiosis;
                                                        treatment of chronic
                                                        ry disease (air-sac
                                                        infection), blue comb
                                                        (nonspecific
                                                        infectious enteritis).
                              Bacitracin 100 to 500..  Turkeys; prevention of  As bacitracin zinc....  .........
                                                        coccidiosis;
                                                        treatment of
                                                        infectious sinusitis,
                                                        blue comb (mud fever).
                              Bacitracin plus          ......do..............  Feed contains 50% to    .........
                               penicillin 100 to 500                            75% of bacitracin but
                               (of combination).                                not more than 125 g
                                                                                penicillin; as
                                                                                procaine penicillin;
                                                                                as bacitracin zinc.
                              Carbarsone 227 to 340.5  Turkeys; aid in         Feed continuously 2        000006
                                                        prevention of           weeks before
                                                        coccidiosis (Eimeria    coccidiosis and
                                                        adenoeides, E.          blackhead are
                                                        meleagrimitis, and E.   expected and continue
                                                        gallopavonis) and       as long as prevention
                                                        blackhead.              is needed; withdraw 5
                                                                                days before
                                                                                slaughter; use as
                                                                                sole source of
                                                                                amprolium and organic
                                                                                arsenic; do not use
                                                                                as a treatment for
                                                                                outbreaks of
                                                                                coccidiosis;
                                                                                carbarsone by 046573
                                                                                in Sec.   510.600(c)
                                                                                of this chapter.
                              Chlortetracycline 100    Chickens where          Do not feed to          .........
                               to 200.                  immunity to             chickens producing
                                                        coccidiosis is not      eggs for human
                                                        desired; prevention     consumption. Feed for
                                                        of coccidiosis;         7 to 14 d.
                                                        control of infectious
                                                        synovitis caused by
                                                        M. synoviae
                                                        susceptible to
                                                        chlortetracycline.
                              Chlortetracycline 200    Chickens where          Do not feed to          .........
                               to 400.                  immunity to             chickens producing
                                                        coccidiosis is not      eggs for human
                                                        desired; control of     consumption. Feed for
                                                        chronic respiratory     7 to 14 d.
                                                        disease (CRD) and air
                                                        sac infection caused
                                                        by M. gallisepticum
                                                        and E. coli
                                                        susceptible to
                                                        chlortetracycline.
                              Erythromycin 4.6 to      Broiler chickens and    As erythromycin         .........
                               18.5.                    replacement chickens    thiocyanate.
                                                        where immunity to
                                                        coccidiosis is not
                                                        desired; prevention
                                                        of coccidiosis;
                                                        growth promotion and
                                                        feed efficiency.
                              Erythromycin 92.5......  1. Broiler chickens     Feed for 2 d before     .........
                                                        and replacement         stress and 3 to 6 d
                                                        chickens where          after stress;
                                                        immunity to             withdraw 24 h before
                                                        coccidiosis is not      slaughter.
                                                        desired; prevention
                                                        of coccidiosis; as an
                                                        aid in the prevention
                                                        of chronic
                                                        respiratory disease
                                                        during periods of
                                                        stress.
                                                       2. Broiler chickens     Feed for 7 to 14 d;     .........
                                                        and replacement         withdraw 24 h before
                                                        chickens where          slaughter.
                                                        immunity to
                                                        coccidiosis is not
                                                        desired; prevention
                                                        of coccidiosis; as an
                                                        aid in the prevention
                                                        of infectious coryza.
                              Erythromycin 185.......  Broiler chickens and    Feed for 5 to 8 d, do   .........
                                                        replacement chickens    not use in birds
                                                        where immunity to       producing eggs for
                                                        coccidiosis is not      food purposes;
                                                        desired; prevention     withdraw 48 h before
                                                        of coccidiosis; as an   slaughter.
                                                        aid in the prevention
                                                        and reduction of
                                                        lesions and in
                                                        lowering severity of
                                                        chronic respiratory
                                                        disease.

[[Page 377]]

 
                              Hygromycin B 8 to 12...  Broiler chickens and    Feed according to       .........
                                                        replacement chickens    subtable in item (i).
                                                        where immunity to
                                                        coccidiosis is not
                                                        desired; prevention
                                                        of coccidiosis;
                                                        control of
                                                        infestation of large
                                                        round worms
                                                        (Heterakis gallinae)
                                                        and capillary worms
                                                        (Capillaria
                                                        obsignata).
                              Penicillin 2.4 to 50...  1. Broiler chickens     As procaine penicillin  .........
                                                        and replacement
                                                        chickens where
                                                        immunity to
                                                        coccidiosis is not
                                                        desired; prevention
                                                        of coccidiosis;
                                                        growth promotion and
                                                        feed efficiency.
                                                       2. Turkeys; prevention  ......do..............  .........
                                                        of coccidiosis;
                                                        growth promotion and
                                                        feed efficiency.
                              Roxarsone 22.7 to 45.4   1. Broiler chickens     Withdraw 5 d before     .........
                               (0.0025% to 0.005%).     and replacement         slaughter; as sole
                                                        chickens where          source of organic
                                                        immunity to             arsenic.
                                                        coccidiosis is not
                                                        desired; prevention
                                                        of coccidiosis;
                                                        growth promotion and
                                                        feed efficiency;
                                                        improving
                                                        pigmentation.
                                                       2. Turkeys; prevention  ......do..............  .........
                                                        of coccidiosis;
                                                        growth promotion and
                                                        feed efficiency;
                                                        improving
                                                        pigmentation.
(v) 227 (0.025%)............  .......................  Laying chickens;        For severe outbreaks    .........
                                                        treatment of            of coccidiosis;
                                                        coccidiosis.            administer for 2
                                                                                weeks.
----------------------------------------------------------------------------------------------------------------

    (3) Pheasants. It is used as follows:
    (i) Amount. 0.0175 percent (159 grams per ton).
    (ii) Indications for use. For the prevention of coccidiosis in 
growing pheasants caused by Eimeria colchici, E. duodenalis, and E. 
phasiani.
    (iii) Limitations. Feed continuously as sole ration. Use as sole 
source of amprolium. Fertility, hatchability, and other reproductive 
data are not available on amprolium in breeding pheasants. Do not use in 
feeds containing bentonite.

[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 on GPO Access.



Sec.  558.58  Amprolium and ethopabate.

    (a) Approvals. Type A medicated articles: (1) 25 percent amprolium 
and 0.8 percent ethopabate; 25 percent amprolium and 8 percent 
ethopabate; 5 percent amprolium and 0.16 percent ethopabate; 5 percent 
amprolium and 1.6 percent ethopabate; to 000006.
    (2) 0.15 percent amprolium and 0.004 percent ethopabate and 0.05 
gram per pound bacitracin (as bacitracin methylene disalicylate) to 
047019 in Sec.  510.600(c) of this chapter.
    (b) Special considerations. Do not use in Type B or Type C medicated 
feeds containing bentonite.
    (c) Related tolerances. See Sec. Sec.  556.50 and 556.260 of this 
chapter.
    (d) Conditions of use. (1) It is used for chickens as follows:

----------------------------------------------------------------------------------------------------------------
 Amprolium and ethopabate in    Combination in grams
        grams per ton                 per ton            Indications for use         Limitations        Sponsor
----------------------------------------------------------------------------------------------------------------
(i) Amprolium 113.5 (0.0125   .......................  Broiler chickens as an  Not for laying hens;    .........
 pct) and ethopabate 3.6                                aid in the prevention   as sole source of
 (0.0004 pct).                                          of coccidiosis.         amprolium.

[[Page 378]]

 
(ii) Amprolium 113.5          Bambermycins 2 to 3      Broiler chickens; as    Feed continuously as    .........
 (0.0125%) and ethopabate      plus roxarsone 22.8 to   an aid in the           the sole ration; as
 3.6 (0.0004%).                34.1 (0.0025% to         prevention of           sole source of
                               0.00375%).               coccidiosis; for        amprolium and organic
                                                        increased rate of       arsenic; amprolium
                                                        weight gain, improved   and ethopabate as
                                                        feed efficiency, and    provided by No.
                                                        pigmentation.           050604 in Sec.
                                                                                510.600(c) of this
                                                                                chapter, roxarsone by
                                                                                No. 046573,
                                                                                bambermycins by No.
                                                                                057926; withdraw 5 d
                                                                                before slaughter.
                              Lincomycin 2 to 4......  Broiler chickens; for   Not for laying          .........
                                                        increase in rate of     chickens; as
                                                        weight gain; improved   lincomycin
                                                        feed efficiency; as     hydrochloride
                                                        an aid in the           monohydrate; as sole
                                                        prevention of           source of amprolium.
                                                        coccidiosis.
                              Lincomycin 2 to 4 plus   Broiler chickens; for   Not for laying          .........
                               roxarsone 45.4           increase in rate of     chickens; as
                               (0.005%).                weight gain; improved   lincomycin
                                                        feed efficiency and     hydrochloride
                                                        pigmentation; as an     monohydrate; withdraw
                                                        aid in the prevention   5 d before slaughter;
                                                        of coccidiosis.         as sole source of
                                                                                amprolium and organic
                                                                                arsenic.
                              Roxarsone 45.4 (0.005    Broiler chickens; to    Do not feed to laying   .........
                               pct).                    aid in prevention of    chickens; withdraw 5
                                                        coccidiosis where       d before slaughter;
                                                        severe exposure to      as sole source of
                                                        coccidiosis from        amprolium; do not use
                                                        Eimeria acervulina,     as a treatment for
                                                        E. maxima, and E.       outbreaks of
                                                        brunetti is likely to   coccidiosis; feed as
                                                        occur; for increased    sole ration from time
                                                        rate of weight gain     chickens are placed
                                                        in broiler chickens     on litter until the
                                                        raised in floor pens.   past the time when
                                                                                coccidiosis is
                                                                                ordinarily a hazard;
                                                                                roxarsone as provided
                                                                                by No. 046573 in Sec.
                                                                                  510.600(c) of this
                                                                                chapter; combinations
                                                                                as provided by No.
                                                                                050604.
(iii) Amprolium 113.5         .......................  Broiler chickens and    Not for chickens over   .........
 (0.0125%) and ethopabate                               replacement chickens    16 weeks of age.
 36.3 (0.004%).                                         where immunity to
                                                        coccidiosis is not
                                                        desired; as an aid in
                                                        the prevention of
                                                        coccidiosis where
                                                        severe exposure to
                                                        coccidiosis from
                                                        Eimeria acervulina,
                                                        E. maxima, and E.
                                                        brunetti is likely to
                                                        occur.
                              Arsanilic acid 90 (0.01  Broiler chickens and    Not for laying hens;       061133
                               pct) plus erythromycin   replacement chickens    withdraw 5 d before
                               4.6 to 18.5.             where immunity to       slaughter; as sole
                                                        coccidiosis is not      source of organic
                                                        desired; prevention     arsenic; as
                                                        of coccidiosis;         erythromycin
                                                        growth promotion and    thiocyanate.
                                                        feed efficiency;
                                                        improve pigmentation.
                              Bacitracin 4 to 50.....  1. Broiler chickens     Not for chickens over   .........
                                                        and replacement         16 weeks of age; do
                                                        chickens where          not feed to laying
                                                        immunity to             chickens; as sole
                                                        coccidiosis is not      source of amprolium;
                                                        desired; to aid in      not for use as a
                                                        prevention of           treatment for
                                                        coccidiosis where       outbreaks of
                                                        severe exposure to      coccidiosis; as
                                                        coccidiosis from        bacitracin methylene
                                                        Eimeria acervulina,     disalicylate as
                                                        E. maxima, and E.       provided by No.
                                                        brunetti is likely to   046573 or bacitracin
                                                        occur; for increased    zinc as provided by
                                                        rate of weight gain     No. 046573 in Sec.
                                                        in broiler chickens     510.600(c) of this
                                                        raised in floor pens.   chapter; feed as the
                                                                                sole ration from the
                                                                                time chickens are
                                                                                placed on litter
                                                                                until past the time
                                                                                when coccidiosis is
                                                                                ordinarily a hazard;
                                                                                combination as
                                                                                provided by No.
                                                                                050604 in Sec.
                                                                                510.600(c) of this
                                                                                chapter.

[[Page 379]]

 
                              .......................  2. Broiler chickens;    Not for chickens over      046573
                                                        as an aid in            16 weeks of age; do
                                                        prevention of           not feed to laying
                                                        coccidiosis where       chickens; as sole
                                                        severe exposure to      source of amprolium;
                                                        coccidiosis from        not for use as a
                                                        Eimeria acervulina,     treatment for
                                                        E. maxima, and E.       coccidiosis;
                                                        brunetti is likely to   bacitracin zinc as
                                                        occur; improved feed    provided by No.
                                                        efficiency.             046573 in Sec.
                                                                                510.600(c) of this
                                                                                chapter; feed as the
                                                                                sole ration from the
                                                                                time chickens are
                                                                                placed on litter
                                                                                until market weight;
                                                                                combination as
                                                                                provided by No.
                                                                                046573..
                              Bacitracin 5 to 35 plus  Broiler chickens; for   Do not feed to laying   .........
                               roxarsone 34             increased rate of       chickens; withdraw 5
                               (0.00375%).              weight gain and as an   d before slaughter;
                                                        aid in the prevention   as sole source of
                                                        of coccidiosis where    amprolium and organic
                                                        severe exposure to      arsenic; do not use
                                                        coccidiosis from        as a treatment for
                                                        Eimeria acervulina,     outbreaks of
                                                        E. maxima, and E.       coccidiosis; feed as
                                                        brunetti is likely to   the sole ration from
                                                        occur in broiler        time chickens are
                                                        chickens raised in      placed on litter
                                                        floor pens.             until past the time
                                                                                when coccidiosis is
                                                                                ordinarily a hazard;
                                                                                amprolium and
                                                                                ethopabate as
                                                                                provided by No.
                                                                                050604 in Sec.
                                                                                510.600(c) of this
                                                                                chapter; bacitracin
                                                                                methylene
                                                                                disalicylate as
                                                                                provided by No.
                                                                                046573 or bacitracin
                                                                                zinc as provided by
                                                                                No. 046573 in Sec.
                                                                                510.600(c) of this
                                                                                chapter; roxarsone as
                                                                                provided by No.
                                                                                046573 in Sec.
                                                                                510.600(c) of this
                                                                                chapter; combination
                                                                                as provided by No.
                                                                                050604 in Sec.
                                                                                510.600(c) of this
                                                                                chapter.
                              Bacitracin 20 to 35      Broiler chickens; for   Do not feed to laying   .........
                               plus roxarsone 34        increased rate of       chickens; withdraw 5
                               (0.00375%).              weight gain, improved   d before slaughter;
                                                        feed efficiency, and    as sole source of
                                                        as an aid in the        amprolium and organic
                                                        prevention of           arsenic; do not use
                                                        coccidiosis where       as a treatment for
                                                        severe exposure to      outbreaks of
                                                        coccidiosis from        coccidiosis; feed as
                                                        Eimeria acervulina,     the sole ration from
                                                        E. maxima, and E.       time chickens are
                                                        brunetti is likely to   placed on litter
                                                        occur in broiler        until past the time
                                                        chickens raised in      when coccidiosis is
                                                        floor pens.             ordinarily a hazard;
                                                                                amprolium and
                                                                                ethopabate as
                                                                                provided by No.
                                                                                050604 in Sec.
                                                                                510.600(c) of this
                                                                                chapter; bacitracin
                                                                                methylene
                                                                                disalicylate as
                                                                                provided by No.
                                                                                046573 in Sec.
                                                                                510.600(c) of this
                                                                                chapter; roxarsone as
                                                                                provided by No.
                                                                                046573 in Sec.
                                                                                510.600(c) of this
                                                                                chapter; combination
                                                                                as provided by No.
                                                                                050604 in Sec.
                                                                                510.600(c) of this
                                                                                chapter.

[[Page 380]]

 
                              Bacitracin 10 to 50      Broiler chickens; as    Do not feed to laying      046573
                               plus roxarsone 15.4 to   an aid in prevention    chickens; withdraw 5
                               45.4 (0.0017% to         of coccidiosis where    d before slaughter;
                               0.005%).                 severe exposure to      as sole source of
                                                        coccidiosis from        amprolium and organic
                                                        Eimeria acervulina,     arsenic; do not use
                                                        E. maxima, and E.       as a treatment for
                                                        brunetti is likely to   outbreaks of
                                                        occur; improved feed    coccidiosis; feed as
                                                        efficiency.             the sole ration from
                                                                                time chicks are
                                                                                placed on litter
                                                                                until past the time
                                                                                when coccidiosis is
                                                                                ordinarily a hazard;
                                                                                amprolium and
                                                                                ethopabate as
                                                                                provided by No.
                                                                                050604 in Sec.
                                                                                510.600(c) of this
                                                                                chapter; bacitracin
                                                                                zinc as provided by
                                                                                No. 046573 roxarsone
                                                                                as provided by No.
                                                                                046573 combination as
                                                                                provided by No.
                                                                                046573.
                              Bacitracin 10 plus       Broiler chickens; as    ......do..............     063238
                               roxarsone 30 to 45.4     an aid in prevention
                               (0.0033% to 0.005%).     of coccidiosis where
                                                        severe exposure to
                                                        coccidiosis from E.
                                                        acervulina, E.
                                                        maxima, and E.
                                                        brunetti is likely to
                                                        occur; improved feed
                                                        efficiency and
                                                        improved pigmentation.
                              Bambermycins 1 to 3....  Broiler chickens; as    Feed continuously as    .........
                                                        an aid in the           the sole ration; as
                                                        prevention of           sole source of
                                                        coccidiosis where       amprolium; amprolium,
                                                        severe exposure to      ethopabate as
                                                        coccidiosis from        provided by No.
                                                        Eimeria acervulina,     050604 in Sec.
                                                        E. maxima, and E.       510.600(c) of this
                                                        brunetti is likely to   chapter, bambermycins
                                                        occur; for increased    as provided by No.
                                                        rate of weight gain,    057926 in Sec.
                                                        and improved feed       510.600(c) of this
                                                        efficiency.             chapter.
                              Bambermycins 1 to 3      Broiler chickens; as    Feed continuously as    .........
                               plus roxarsone 22.8 to   an aid in the           the sole ration; as
                               34.1 (0.0025% to         prevention of           sole source of
                               0.00375%).               coccidiosis where       amprolium and organic
                                                        severe exposure to      arsenic; amprolium
                                                        coccidiosis from        and ethopabate as
                                                        Eimeria acervulina,     provided by No.
                                                        E. maxima, and E.       050604 in Sec.
                                                        brunetti is likely to   510.600(c) of this
                                                        occur; for increased    chapter, roxarsone by
                                                        rate of weight gain;    No. 046573
                                                        improved feed           bambermycins by No.
                                                        efficiency, and         057926. Withdraw 5
                                                        improved pigmentation.  days before slaughter.
                              Erythromycin 4.6 to      Broiler chickens and    Not for laying hens;    .........
                               18.5.                    replacement chickens    withdraw 24 hours
                                                        where immunity to       before slaughter;
                                                        coccidiosis is not      erythromycin
                                                        desired; prevention     thiocyanate.
                                                        of coccidiosis;
                                                        growth promotion and
                                                        feed efficiency.
                              Virginiamycin, 15......  Broiler chickens, as    Feed continuously as       000069
                                                        an aid in the           sole ration, do not
                                                        prevention of           feed to laying hens,
                                                        coccidiosis where       not for chickens over
                                                        severe exposure to      16 weeks of age, as
                                                        Eimeria acervulina,     sole source of
                                                        E. brunetti, and E.     amprolium, amprolium
                                                        maxima is likely to     and ethopabate as
                                                        occur, for increased    provided by 050604 in
                                                        rate of weight gain     Sec.   510.600(c),
                                                        and improved feed       virginiamycin as
                                                        efficiency.             provided by 066104.
                              Virginiamycin, 5 to 15.  Broiler chickens, as    ......do..............  .........
                                                        an aid in the
                                                        prevention of
                                                        coccidiosis where
                                                        severe exposure to
                                                        Eimeria acervulina,
                                                        E. brunetti, and E.
                                                        maxima is likely to
                                                        occur, for increased
                                                        rate of weight gain.
(iv) Amprolium 113.5 to 227   .......................  For broiler chickens    Not for laying hens...  .........
 (0.0125% to 0.025%) and                                and replacement
 ethopabate 3.6 (0.0004%).                              chickens where
                                                        immunity to
                                                        coccidiosis is not
                                                        desired; prevention
                                                        of coccidiosis.

[[Page 381]]

 
                              Arsanilic acid 90        Broiler chickens and    As sole source of       .........
                               (0.01%).                 replacement chickens    organic arsenic;
                                                        where immunity to       withdraw 5 d before
                                                        coccidiosis is not      slaughter; not for
                                                        desired; prevention     laying hens.
                                                        of coccidiosis;
                                                        growth promotion and
                                                        feed efficiency;
                                                        improving
                                                        pigmentation.
                              Arsanilic acid 90        1. For broiler          Feed for 2 d before     .........
                               (0.01%) plus             chickens and            stress and 3 to 6 d
                               erythromycin 92.5.       replacement chickens    after stress;
                                                        where immunity to       withdraw 5 d before
                                                        coccidiosis is not      slaughter; as sole
                                                        desired; prevention     source of organic
                                                        of coccidiosis; as an   arsenic; not for
                                                        aid in the prevention   laying hens.
                                                        of chronic
                                                        respiratory disease
                                                        during periods of
                                                        stress; growth
                                                        promotion and feed
                                                        efficiency; improving
                                                        pigmentation.
                                                       2. For broiler          Feed for 7 to 14 d;     .........
                                                        chickens and            withdraw 5 d before
                                                        replacement chickens    slaughter; as sole
                                                        where immunity to       source of organic
                                                        coccidiosis is not      arsenic; not for
                                                        desired; prevention     laying hens.
                                                        of coccidiosis; as an
                                                        aid in the prevention
                                                        of infectious coryza;
                                                        growth promotion and
                                                        feed efficiency;
                                                        improving
                                                        pigmentation.
                              Arsanilic acid 90        For broiler chickens    Feed for 5 to 8 d; do   .........
                               (0.01%) plus             and replacement         not use in birds
                               erythromycin 185.        chickens where          producing eggs for
                                                        immunity to             food purposes;
                                                        coccidiosis is not      withdraw 5 d before
                                                        desired; prevention     slaughter; as sole
                                                        of coccidiosis; as an   source of organic
                                                        aid in the prevention   arsenic.
                                                        and reduction of
                                                        lesions and in
                                                        lowering severity of
                                                        chronic respiratory
                                                        disease; growth
                                                        promotion and feed
                                                        efficiency; improving
                                                        pigmentation.
                              Bacitracin 4 to 50.....  For broiler chickens    As bacitracin           .........
                                                        and replacement         methylene
                                                        chickens where          disalicylate; not for
                                                        immunity to             laying hens.
                                                        coccidiosis is not
                                                        desired; prevention
                                                        of coccidiosis;
                                                        growth promotion and
                                                        feed efficiency.
                              Bacitracin 100 to 200..  1. Broiler chickens     ......do..............  .........
                                                        and replacement
                                                        chickens where
                                                        immunity to
                                                        coccidiosis is not
                                                        desired; prevention
                                                        of coccidiosis;
                                                        treatment of chronic
                                                        respiratory disease
                                                        (air-sac infection)
                                                        and blue comb
                                                        (nonspecific
                                                        infectious enteritis).
                                                       2. For broiler          As zinc bacitracin,     .........
                                                        chickens and            not for laying hens.
                                                        replacement chickens
                                                        where immunity to
                                                        coccidiosis is not
                                                        desired; prevention
                                                        of coccidiosis;
                                                        treatment of chronic
                                                        respiratory disease
                                                        (air-sac infection),
                                                        blue comb
                                                        (nonspecific
                                                        infectious enteritis).
                              Bacitracin 4 to 50 plus  Broiler chickens and    As bacitracin           .........
                               roxarsone 22.7 to 45.4   replacement chickens    methylene
                               (0.0025% to 0.005%).     where immunity to       disalicylate; not for
                                                        coccidiosis is not      laying hens; as sole
                                                        desired; prevention     source of organic
                                                        of coccidiosis;         arsenic; withdraw 5 d
                                                        growth promotion and    before slaughter.
                                                        feed efficiency;
                                                        improving
                                                        pigmentation.
                              Chlortetracycline 100    For chickens where      Do not feed to          .........
                               to 200.                  immunity to             chickens producing
                                                        coccidiosis is not      eggs for human
                                                        desired; prevention     consumption. Feed for
                                                        of coccidiosis;         7 to 14 d.
                                                        control of infectious
                                                        synovitis caused by
                                                        Mycoplasma synoviae
                                                        susceptible to
                                                        chlortetracycline.

[[Page 382]]

 
                              Chlortetracycline 200    For chickens where      In low calcium feed     .........
                               to 400.                  immunity to             containing 0.8%
                                                        coccidiosis is not      dietary calcium and
                                                        desired; prevention     1.5% sodium sulfate;
                                                        of coccidiosis;         feed continuously as
                                                        control of chronic      sole ration for 7 to
                                                        respiratory disease     14 d; do not feed to
                                                        (CRD) and air sac       chickens producing
                                                        infection caused by     eggs for human
                                                        M. gallisepticum and    consumption.
                                                        E. coli susceptible
                                                        to chlortetracycline.
                              Erythromycin 92.5......  1. For broiler          Feed for 2 d before     .........
                                                        chickens and for        stress and 3 to 6 d
                                                        replacement chickens    after stress;
                                                        where immunity to       withdraw 24 h before
                                                        coccidiosis is not      slaughter; not for
                                                        desired; prevention     laying hens.
                                                        of coccidiosis; as an
                                                        aid in the prevention
                                                        of chronic
                                                        respiratory disease
                                                        during periods of
                                                        stress.
                                                       2. For broiler          Feed for 7 to 14 d;     .........
                                                        chickens and            withdraw 24 h before
                                                        replacement chickens    slaughter; not for
                                                        where immunity to       laying hens.
                                                        coccidiosis is not
                                                        desired; prevention
                                                        of coccidiosis; as an
                                                        aid in the prevention
                                                        of infectious coryza.
                              Erythromycin 185.......  For broiler chickens    Feed for 5 to 8 d; do   .........
                                                        and replacement         not use in birds
                                                        chickens where          producing eggs for
                                                        immunity to             food purposes;
                                                        coccidiosis is not      withdraw 48 h before
                                                        desired; prevention     slaughter.
                                                        of coccidiosis; as an
                                                        aid in the prevention
                                                        and reduction of
                                                        lesions and in
                                                        lowering severity of
                                                        chronic respiratory
                                                        disease.
                              Penicillin 2.4 to 50...  For broiler chickens    Not for laying hens;    .........
                                                        and replacement         as procaine
                                                        chickens where          penicillin.
                                                        immunity to
                                                        coccidiosis is not
                                                        desired; prevention
                                                        of coccidiosis;
                                                        growth promotion and
                                                        feed efficiency;
                                                        improving
                                                        pigmentation.
                              Roxarsone 22.7 to 45.4   Broiler chickens and    As sole source of       .........
                               (0.0025% to 0.005%).     replacement chickens    organic arsenic;
                                                        where immunity to       withdraw 5 d before
                                                        coccidiosis is not      slaughter; not for
                                                        desired; prevention     laying hens.
                                                        of coccidiosis;
                                                        growth promotion and
                                                        feed efficiency;
                                                        improving
                                                        pigmentation.
----------------------------------------------------------------------------------------------------------------

    (2) [Reserved]

[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 on GPO Access.



Sec.  558.59  Apramycin.

    (a) Approvals. Type A articles to sponsors identified in Sec.  
510.600(c) of this chapter as follows:
    (1) 000986 for 75 grams apramycin (as apramycin sulfate) per pound 
for use as in paragraph (d)(1) of this section.
    (2) [Reserved]
    (b) [Reserved]
    (c) Related tolerances. See Sec.  556.52 of this chapter.
    (d) Conditions of use--(1) Swine--(i) Amount. 150 grams per ton.
    (ii) Indications for use. For control of porcine colibacillosis 
(weanling pig scours) caused by susceptible strains of Escherichia coli.
    (iii) Limitations. Use for 14 days. Withdraw 28 days before 
slaughter.
    (2) [Reserved]

[51 FR 9190, Mar. 18, 1986]



Sec.  558.60  Arsanilate sodium.

    (a) Appprovals. Type A medicated articles: 20, 50, or 100 percent to 
015565 in Sec.  510.600(c) of this chapter.
    (b) Related tolerances. See Sec.  556.60 of this chapter.
    (c) Conditions of use. (1) It is used for chickens and turkeys as 
follows:

[[Page 383]]

    (i) Grams per ton. 90 (0.01 percent).
    (ii) Indications for use. For growth promotion and feed efficiency; 
improving pigmentation.
    (iii) Limitations. Withdraw 5 days before slaughter; as sole source 
of organic arsenic.
    (2) Arsanilate sodium may be used in accordance with the provisions 
of this section in the combinations provided as follows:
    (i) Amprolium in accordance with Sec.  558.55.
    (ii) Zoalene in accordance with Sec.  558.680.

[41 FR 10992, Mar. 15, 1976, as amended at 51 FR 7395, Mar. 3, 1986; 51 
FR 33897, Sept. 24, 1986]



Sec.  558.62  Arsanilic acid.

    (a) Approvals. Type A medicated articles to sponsors in Sec.  
510.600(c) of this chapter as follows:
    (1) To 015565: 20, 50, and 100 percent for use as in the table in 
paragraph (c)(1), entry (ii), item 1; entry (ii), item 2; entry (iv); 
entry (vi); and entry (vii) of this section.
    (2) To 015565: 20 percent for use as in paragraph (c)(1), entry (i); 
entry (ii), item 3 of this section.
    (3) To 061133: 90 grams per pound arsanilic acid and 4.6 grams per 
pound erythromycin equivalents as erythromycin thiocyanate for use as in 
paragraph (c)(1), entry (iii); 90 grams per pound arsanilic acid and 
9.25 grams per pound erythromycin equivalents as erythromycin 
thiocyanate for use as in paragraph (c)(1), entry (v).
    (b) Related tolerances. See Sec.  556.60 of this chapter.
    (c) Conditions of use. (1) It is used as follows:

----------------------------------------------------------------------------------------------------------------
 Arsanilic acid in grams per    Combination in grams
             ton                      per ton            Indications for use         Limitations        Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 45 to 90................  .......................  1. Growing chickens:    Withdraw 5 days before     015565
                                                        For growth promotion    slaughter; as sole
                                                        and feed efficiency;    source of organic
                                                        improving               arsenic.
                                                        pigmentation.
                              .......................  2. Growing turkeys:     .......do.............     015565
                                                        For growth promotion
                                                        and feed efficiency;
                                                        improving
                                                        pigmentation.
                              .......................  3. Growing swine: For   .......do.............     015565
                                                        increased rate of
                                                        weight gain and
                                                        improved feed
                                                        efficiency.
(ii) 90.....................  .......................  Swine: As an aid in     .......do.............     015565
                                                        control of swine
                                                        dysentery
                                                        (hemorrhagic
                                                        enteritis, bloody
                                                        dysentery).
(iii).......................  Erythromycin 4.6.......  Chickens; growth        As erythromycin            012487
                                                        promotion and feed      thiocyanate; withdraw
                                                        efficiency; improving   5 days before
                                                        pigmentation..          slaughter; as sole
                                                                                source of organic
                                                                                arsenic..
(iv)........................  Erythromycin 4.6 to      Chickens; growth        As erythromycin             15565
                               18.5.                    promotion and feed      thiocyanate; withdraw
                                                        efficiency; improving   5 days before
                                                        pigmentation.           slaughter; as sole
                                                                                source of organic
                                                                                arsenic.
(v).........................  Erythromycin 9.25......  Chickens; growth        As erythromycin            012487
                                                        promotion and feed      thiocyanate; withdraw
                                                        efficiency; improving   5 days before
                                                        pigmentation..          slaughter; as sole
                                                                                source of organic
                                                                                arsenic..
(vi)........................  Erythromycin 92.5......  1. Chickens; as an aid  As erythromycin            015565
                                                        in the prevention of    thiocyanate; feed for
                                                        chronic respiratory     2 days before stress
                                                        disease during          and 3 to 6 days after
                                                        periods of stress;      stress; withdraw 5
                                                        growth promotion and    days before
                                                        feed efficiency;        slaughter; as sole
                                                        improving               source of organic
                                                        pigmentation.           arsenic.
                                                       2. Chickens; as an aid  As erythromycin            015565
                                                        in the prevention of    thiocyanate; feed for
                                                        infectious coryza;      7 to 14 days;
                                                        growth promotion and    withdraw 5 days
                                                        feed efficiency;        before slaughter; as
                                                        improving               sole source of
                                                        pigmentation.           organic arsenic.
(vii).......................  Erythromycin 185.......  Chickens; as an aid in  As erythromycin             15565
                                                        the prevention and      thiocyanate; feed for
                                                        reduction of lesions    5 to 8 days; do not
                                                        and in lowering         use in birds
                                                        severity of chronic     producing eggs for
                                                        respiratory disease;    food purposes;
                                                        growth promotion and    withdraw 5 days
                                                        feed efficiency;        before slaughter; as
                                                        improving               sole source of
                                                        pigmentation.           organic arsenic.
----------------------------------------------------------------------------------------------------------------


[[Page 384]]

    (2) Arsanilic acid may be used in accordance with the provisions of 
this section in the combinations provided as follows:
    (i) Amprolium in accordance with Sec.  558.55.
    (ii) Amprolium and ethopabate in accordance with Sec.  558.58.
    (iii) Bacitracin zinc in accordance with Sec.  558.78.
    (iv) Bacitracin and zoalene in accordance with Sec.  558.680.
    (v) Zoalene in accordance with Sec.  558.680.

[41 FR 10992, Mar. 15, 1976, as amended at 42 FR 18617, Apr. 8, 1977; 51 
FR 7395, Mar. 3, 1986; 51 FR 33897, Sept. 24, 1986; 54 FR 18281, Apr. 
28, 1989; 56 FR 19268, Apr. 26, 1991; 60 FR 39847, Aug. 4, 1995; 66 FR 
14074, Mar. 9, 2001; 66 FR 57873, Nov. 19, 2001]



Sec.  558.76  Bacitracin methylene disalicylate.

    (a) Approvals. Type A medicated articles: 10, 25, 30, 40, 50, 60, or 
75 grams per pound to 046573 in Sec.  510.600(c) of this chapter.
    (b) Special considerations. The quantities of antibiotics are 
expressed in terms of the equivalent amount of antibiotic standard.
    (c) Related tolerances. See Sec.  556.70 of this chapter.
    (d) Conditions of use. (1) It is used as follows:

----------------------------------------------------------------------------------------------------------------
    Bacitracin methylene
  disalicylate in grams per     Combination in grams     Indications for use         Limitations        Sponsor
             ton                      per ton
----------------------------------------------------------------------------------------------------------------
(i) 4 to 50.................  .......................  Chickens, turkeys, and  ......................     046573
                                                        pheasants; increased
                                                        rate of weight gain
                                                        and improved feed
                                                        efficiency \1\.
(ii) 5 to 20................  .......................  Quail not over 5 weeks  ......................     046573
                                                        of age; increased
                                                        rate of weight gain
                                                        and improved feed
                                                        efficiency \1\.
(iii) 10 to 25..............  .......................  Chickens; for           For first 7 months of      046573
                                                        increased egg           production.
                                                        production and
                                                        improved feed
                                                        efficiency for egg
                                                        production.
(iv) 10 to 30...............  .......................  Swine: for increased    For growing and            046573
                                                        rate of weight gain     finishing swine.
                                                        and improved feed
                                                        efficiency.
                              Chlortetracycline        Swine; for increased    Feed for not more than     046573
                               approximately 400,       rate of weight gain     14 days to provide 10
                               varying with body        and improved feed       milligrams of
                               weight and food          efficiency; for         chlortetracycline per
                               consumption to provide   treatment of            pound of body weight
                               10 milligrams per        bacterial enteritis     per day; as
                               pound of body weight     caused by Escherichia   chlortetracycline
                               per day.                 coli and Salmonella     provided by No.
                                                        choleraesuis and        046573 in Sec.
                                                        bacterial pneumonia     510.600(c) of this
                                                        caused by Pasteurella   chapter. Type C feed
                                                        multocida susceptible   may be prepared from
                                                        to chlortetracycline.   Type B feed
                                                                                containing 1 to 3
                                                                                grams per pound BMD
                                                                                with 400 grams per
                                                                                pound CTC, to 046573
                                                                                in Sec.   510.600(c).
                              .......................  Swine; for control of   Feed for not more than     046573
                                                        porcine proliferative   14 days;
                                                        enteropathies           chlortetracycline and
                                                        (ileitis) caused by     BMD[reg] as provided
                                                        Lawsonia                by 046573 in Sec.
                                                        intracellularis         510.600(c) of this
                                                        susceptible to          chapter.
                                                        chlortetracycline..
(v) [Reserved]
(vi) 50.....................  .......................  Broiler chickens; as    ......................     046573
                                                        an aid in the
                                                        prevention of
                                                        necrotic enteritis
                                                        caused or complicated
                                                        by Clostridium spp.
                                                        or other organisms
                                                        susceptible to
                                                        bacitracin.
                              .......................  Replacement chickens;   Feed continuously as       046573
                                                        as an aid in the        sole ration.
                                                        prevention of
                                                        necrotic enteritis
                                                        caused or complicated
                                                        by Clostridium spp.
                                                        or other organisms
                                                        susceptible to
                                                        bacitracin

[[Page 385]]

 
(vii)-(viii) [Reserved]
(ix) 100 to 200.............  .......................  Broiler chickens; as    ......................     046573
                                                        an aid in the control
                                                        of necrotic enteritis
                                                        caused or complicated
                                                        by Clostridium spp.
                                                        or other organisms
                                                        susceptible to
                                                        bacitracin.
                              .......................  Replacement chickens;    Feed continuously as      046573
                                                        as an aid in the        sole ration. Start at
                                                        control of necrotic     first clinical signs
                                                        enteritis caused or     of disease, vary
                                                        complicated by          dosage based on
                                                        Clostridium spp. or     severity of
                                                        other organisms         infection, administer
                                                        susceptible to          continuously for 5 to
                                                        bacitracin              7 days or as long as
                                                                                clinical signs
                                                                                persist, then reduce
                                                                                medication to
                                                                                prevention level (50
                                                                                g/t).
(x) 200.....................  .......................  Turkeys; as an aid in   ......................     046573
                                                        the control of
                                                        transmissible
                                                        enteritis in growing
                                                        turkeys complicated
                                                        by organisms
                                                        susceptible to
                                                        bacitracin methylene
                                                        disalicylate.
                              .......................  Quail; for the          From Type A medicated      046573
                                                        prevention of           articles containing
                                                        ulcerative enteritis    25, 40, or 50 grams
                                                        in growing quail due    of bacitracin
                                                        to Clostridium          methylene
                                                        colinum susceptible     disalicylate. Feed
                                                        to bacitracin           continuously as the
                                                        methylene               sole ration.
                                                        disalicylate
(xi) 250....................  .......................  1. Growing/Finishing    As the sole ration.        046573
                                                        Swine: For control of   Not for use in swine
                                                        swine dysentery         weighing more than
                                                        associated with         250 pounds. Diagnosis
                                                        Treponema               should be confirmed
                                                        hyodysenteriae on       by a veterinarian
                                                        premises with a         when results are not
                                                        history of swine        satisfactory.
                                                        dysentery but where
                                                        signs of 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 a
                                                                                veterinarian when
                                                                                results are not
                                                                                satisfactory.
----------------------------------------------------------------------------------------------------------------
\1\ These conditions are NAS/NRC reviewed and found effective. Applications for these uses may not require
  effectiveness data as specified by Sec.   514.111 of this chapter, but may require bioequivalency and safety
  information.

    (2) It is used as bacitracin methylene disalicylate in feed for 
animals as follows:
    (i) Amount. 70 milligrams per head per day.
    (a) Indications for use. Feedlot beef cattle; reduction in the 
number of liver condemnations due to abscesses.
    (b) Limitations. Administer continuously throughout the feeding 
period.
    (ii) Amount. 250 milligrams per head per day.
    (a) Indications for use. Feedlot beef cattle; reduction in the 
number of liver condemnations due to abscesses.
    (b) Limitations. Administer continuously for 5 days then discontinue 
for subsequent 25 days, repeat the pattern during the feeding period.
    (3) Bacitracin methylene disalicylate may also be used with:
    (i) Amprolium as in Sec.  558.55.
    (ii) Amprolium and ethopabate as in Sec.  558.58.
    (iii) Carbarsone (not USP) as in Sec.  558.120.
    (iv) Decoquinate alone and with roxarsone as in Sec.  558.195.
    (v) Diclazuril alone and with roxarsone as in Sec.  558.198.
    (vi) Fenbendazole as in Sec.  558.258.
    (vii) Halofuginone hydrobromide alone and with roxarsone as in Sec.  
558.265.
    (viii) Hygromycin B as in Sec.  588.274.
    (ix) Ivermectin as in Sec.  558.300.

[[Page 386]]

    (x) Lasalocid sodium alone and with roxarsone as in Sec.  558.311.
    (xi) Monensin alone and with roxarsone as in Sec.  588.355.
    (xii) Narasin alone and with roxarsone as in Sec.  558.363.
    (xiii) Nicarbazin alone and with narasin or narasin and roxarsone as 
in Sec.  558.366.
    (xiv) Nitarsone as in Sec.  558.369.
    (xv) Robenidine alone and with roxarsone as in Sec.  558.515.
    (xvi) Salinomycin alone and with roxarsone as in Sec.  558.550.
    (xvii) Semduramicin alone and with roxarsone as in Sec.  558.555.
    (xviii) Zoalene alone and with arsanilic acid as in Sec.  558.680.

[41 FR 10993, Mar. 15, 1976]

    Editorial Note: 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 on GPO Access.



Sec.  558.78  Bacitracin zinc.

    (a) Approvals. To sponsors listed in Sec.  510.600(c) of this 
chapter for use as in paragraph (d) of this section as follows:
    (1) No. 046573: 10, 25, 40, and 50 grams per pound as in paragraph 
(d) of this section.
    (2) No. 053389: 5 and 50 grams per pound for chickens as in 
paragraph (d)(1)(i) of this section.
    (b) Special considerations. The quantities of antibiotics are 
expressed in terms of the equivalent amount of antibiotic standard.
    (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, turkeys, and  Growing chickens,          046573
                                                        pheasants; for          turkeys, and
                                                        increased rate of       pheasants.
                                                        weight gain and
                                                        improved feed
                                                        efficiency.
(ii) 5 to 20................  .......................  Quail; for increased    Growing quail; feed as     046573
                                                        rate of weight gain     the Type C feed to
                                                        and improved feed       starting quail
                                                        efficiency.             through 5 weeks of
                                                                                age.
(iii) 10 to 25..............  .......................  Laying chickens;        ......................     046573
                                                        improved feed
                                                        efficiency and
                                                        increased egg
                                                        production.
(iv) 10 to 50...............  .......................  Swine; increased rate   Growing and finishing      046573
                                                        of weight gain and      swine.
                                                        improved feed
                                                        efficiency.
(v) 20......................  .......................  Growing-finishing       In Type C feed........     046573
                                                        swine; increased rate
                                                        of weight gain.
(vi) 20 to 40...............  .......................  Growing-finishing       ......do..............     046573
                                                        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 046573.
    (3) It may be used as approved in combination with:
    (i) Amprolium alone and with roxarsone as in Sec.  558.55.
    (ii) Amprolium and ethopabate alone and with roxarsone as in Sec.  
558.58.
    (iii) Carbarsone as in Sec.  558.120.
    (iv) Clopidol alone and with roxarsone as in Sec.  558.175.
    (v) Decoquinate alone and with roxarsone as in Sec.  558.195.
    (vi) Hygromycin B alone and with penicillin as in Sec.  558.274.
    (vii) Lasalocid sodium alone or with roxarsone as in Sec.  558.311.
    (viii) Monensin alone and with roxarsone as in Sec.  558.355.
    (ix) Naracin as in Sec.  558.363.
    (x) Robenidine as in Sec.  558.515.
    (xi) Salinomycin alone and with roxarsone as in Sec.  558.550.
    (xii) Zoalene alone and with arsanilic acid or roxarsone as in Sec.  
558.680.

[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

[[Page 387]]

Finding Aids section of the printed volume and on GPO Access.



Sec.  558.95  Bambermycins.

    (a) Approvals. To sponsors identified by drug labeler codes in Sec.  
510.600(c) of this chapter for use of bambermycins Type A medicated 
articles as bambermycins activity per pound in paragraph (d) of this 
section as follows:
    (1) To 057926: 2, 4, and 10 grams for use as in paragraphs (d)(1), 
(d)(2), (d)(3), and (d)(4) of this section.
    (2) To 057926: 0.4 gram for use as in paragraph (d)(2) of this 
section.
    (3) To 011490: 0.4 and 2 grams for use as in paragraph (d)(2) of 
this section.
    (4) To 016968, 017519, and 017790: 0.4 and 2 grams for use as in 
paragraph (d)(2) and 2 grams for use as in paragraph (d)(3) of this 
section.
    (5) To 057926: 10 grams to make 40 to 800 grams per ton Type B feed 
for use as in paragraph (d)(4) of this section.
    (b) 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.
    (c) [Reserved]
    (d) Conditions of use--(1) Broiler chickens. It is used as follows:
    (i) Amount per ton. 1 to 2 grams.
    (a) Indications for use. For increased rate of weight gain and 
improved feed efficiency.
    (b) Limitations. Feed continuously as the sole ration.
    (ii) Amount per ton. Bambermycins, 1 to 3 grams plus amprolium, 
113.5 grams (.0125 percent) plus ethopabate, 36.3 grams (.004 percent).
    (a) Indications for use. As an aid in the prevention of coccidiosis 
where severe exposure to coccidiosis from E. acervulina, E. maxima, and 
E. brunetti is likely to occur. For increased rate of weight gain and 
improved feed efficiency.
    (b) Limitations. Feed continuously as the sole ration; as sole 
source of amprolium; amprolium and ethopabate as provided by No. 050604 
in Sec.  510.600(c) of this chapter.
    (iii) Amount per ton. Bambermycins, 1 to 3 grams plus amprolium, 
113.5 grams (.0125 percent) plus ethopabate, 36.3 grams (.004 percent) 
plus roxarsone, 22.8 to 34.1 grams (.0025-.00375 percent).
    (a) Indications for use. As an aid in the prevention of coccidiosis 
where severe exposure to coccidiosis from E. acervulina, E. maxima, and 
E. brunetti is likely to occur. For increased rate of weight gain, 
improved feed efficiency, and improved pigmentation.
    (b) Limitations. Feed continuously as the sole ration; as sole 
source of amprolium and organic arsenic; amprolium and ethopabate as 
provided by No. 050604 in Sec.  510.600(c) of this chapter, roxarsone as 
provided by No. 046573 in Sec.  510.600(c) of this chapter. Withdraw 5 
days before slaughter.
    (iv) Amount per ton. Bambermycins, 1 to 3 grams plus amprolium, 
113.5 grams (.0125 percent) plus ethopabate, 3.63 grams (.004 percent) 
plus roxarsone, 22.8 to 34.1 grams (.0025-.00375 percent).
    (a) Indications for use. As an aid in the prevention of coccidiosis. 
For increased rate of weight gain, improved feed efficiency, and 
improved pigmentation.
    (b) Limitations. Feed continuously as the sole ration; as sole 
source of amprolium and organic arsenic; amprolium and ethopabate as 
provided by No. 050604 in Sec.  510.600(c) of this chapter, roxarsone as 
provided by No. 046573 in Sec.  510.600(c) of this chapter. Withdraw 5 
days before slaughter.
    (v) Amount per ton. Bambermycins, 1 to 3 grams plus amprolium, 113.5 
grams (.0125 percent) plus roxarsone, 22.8 to 34.1 grams (.0025-.00375 
percent).
    (a) Indications for use. As an aid in the prevention of coccidiosis. 
For increased rate of weight gain, improved feed efficiency, and 
improved pigmentation.
    (b) Limitations. Feed continuously as the sole ration; as sole 
source of amprolium and organic arsenic; amprolium as provided by No. 
050604 in Sec.  510.600(c) of this chapter, roxarsone as provided by No. 
046573 in Sec.  510.600(c) of this chapter. Withdraw 5 days before 
slaughter.

[[Page 388]]

    (vi) Amount per ton. Bambermycins, 1 to 2 grams plus monensin, 90 to 
110 grams.
    (a) Indications for use. For increased rate of weight gain and 
improved feed efficiency; as an aid in the prevention of coccidiosis 
caused by E. necatrix, E. tenella, E. acervulina, E. brunetti, E. 
mivati, and E. maxima.
    (b) Limitations. Do not feed to laying chickens; feed continuously 
as sole ration; as monensin sodium provided by No. 000986 in Sec.  
510.600(c) of this chapter; as bambermycins provided by No. 057926 in 
Sec.  510.600(c) of this chapter.
    (vii) Amount per ton. Bambermycins, 1 gram plus monensin, 90 to 110 
grams plus roxarsone, 22.7 to 45.4 grams (.0025 to .005 percent).
    (a) Indications for use. For increased rate of weight gain and 
improved feed efficiency; as an aid in the prevention of coccidiosis 
caused by E. necatrix, E tenella, E. acervulina, E. brunetti, E. mivati, 
and E. maxima.
    (b) Limitations. Do not feed to laying chickens; feed continuously 
as sole ration; use as sole source of organic arsenic; withdraw 5 days 
before slaughter; as monensin sodium provided by No. 000986 in Sec.  
510.600(c) of this chapter; as bambermycins provided by No. 057926 in 
Sec.  510.600(c) of this chapter; as roxarsone provided by No. 046573 in 
Sec.  510.600(c) of this chapter.
    (viii) Amount per ton. Bambermycins, 1 gram plus zoalene, 113.4 
grams (0.0125 percent).
    (a) Indications for use. As an aid in the prevention and control of 
coccidiosis; for increased rate of weight gain and improved feed 
efficiency.
    (b) Limitations. Do not feed to chickens over 14 weeks of age; feed 
continuously as sole ration; zoalene as provided by No. 025700 in Sec.  
510.600(c) of this chapter.
    (ix) Amount per ton. Bambermycins, 1 gram plus zoalene, 113.4 grams 
(0.0125 percent) plus roxarsone, 22.7 grams (0.0025 percent).
    (a) Indications for use. As an aid in the prevention and control of 
coccidiosis; for increased rate of weight gain and improved feed 
efficiency.
    (b) Limitations. Do not feed to chickens over 14 weeks of age; feed 
continuously as sole ration; feed as sole source of organic arsenic; 
withdraw 5 days before slaughter; zoalene as provided by No. 025700, 
roxarsone as provided by No. 046573 in Sec.  510.600(c) of this chapter.
    (x) [Reserved]
    (xi) Amount per ton. Bambermycins 1 to 2 grams, plus roxarsone 45.4 
grams, and salinomycin 40 to 60 grams.
    (a) Indications for use. For prevention of coccidiosis caused by 
Eimeria necatrix, E. acervulina, E. maxima, E. brunetti, E. tenella, and 
E. mivati, including some field strains of E. tenella that are more 
susceptible to roxarsone combined with salinomycin than salinomycin 
alone; and for improved feed efficiency.
    (b) Limitations. For broiler chickens only; do not feed to laying 
chickens; feed continuously as sole ration; as sole source or organic 
arsenic; withdraw 5 days before slaughter; not approved for use with 
pellet binders; may be fatal if accidentally fed to adult turkeys or 
horses; as roxarsone provided by No. 011526 or 046573 in Sec.  
510.600(c) of this chapter; as salinomycin sodium biomass provided by 
Nos. 046573 and 057926 in Sec.  510.600(c) of this chapter.
    (xii) Amount per ton. Bambermycins 1 to 3 grams, plus salinomycin 40 
to 60 grams.
    (a) Indications for use. For prevention of coccidiosis caused by 
Eimeria tenella, E. necatrix, E. acervulina, E. brunetti, E. mivati, and 
E. maxima; and improved feed efficiency.
    (b) Limitations. For broiler chickens only: Do not feed to laying 
chickens; feed continuously as sole ration; not approved for use with 
pellet binders; may be fatal if accidentally fed to adult turkeys or 
horses; as salinomycin sodium biomass provided by Nos. 046573 and 057926 
in Sec.  510.600(c) of this chapter.
    (xiii) Amount per ton. Bambermycins, 1 to 2 grams plus monensin, 90 
to 110 grams plus roxarsone, 22.7 to 45.4 grams (0.0025 to 0.005 
percent).
    (a) Indications for use. For increased rate of weight gain; as an 
aid in prevention of coccidiosis caused by E. necatrix, E. tenella, E. 
acervulina, E. brunetti, E. mivati, and E. maxima.
    (b) Limitations. See paragraph (b)(1)(vii)(b) of this section.
    (xiv) Amount per ton. Bambermycins 1 to 2 grams, plus lasalocid 68 
to 113 grams.

[[Page 389]]

    (a) Indications for use. For prevention of coccidiosis caused by E. 
tenella, E. necatrix, E. acervulina, E. brunetti, E. mivati, and E. 
maxima, and for increased rate of weight gain and improved feed 
efficiency in broiler chickens.
    (b) Limitations. For broiler chickens only. Feed continuously as 
sole ration. Lasalocid as provided by No. 046573 in Sec.  510.600(c) of 
this chapter.
    (2) Growing-finishing swine. It is used as follows:
    (i) Amount per ton. 2 grams.
    (a) Indications for use. For increased rate of weight gain and 
improved feed efficiency.
    (b) Limitations. Feed continuously as sole ration.
    (ii) Amount per ton. 2 to 4 grams.
    (a) Indications for use. For increased rate of weight gain.
    (b) Limitations. Feed continuously as sole ration.
    (3) Growing turkeys. It is used as follows:
    (i) Amount per ton. 1 to 2 grams.
    (a) Indications for use. For improved feed efficiency.
    (b) Limitations. Feed continuously as the sole ration.
    (ii) Amount per ton. 2 grams.
    (a) Indications for use. For increased rate of weight gain and 
improved feed efficiency.
    (b) Limitations. Feed continuously as sole ration.
    (iii) Amount per ton. Bambermycins, 1 to 4 grams plus amprolium, 
113.5 grams (.0125 percent).
    (a) Indications for use. For prevention of coccidiosis; for 
increased rate of weight gain and improved feed efficiency.
    (b) Limitations. Feed continously as the sole source of amprolium; 
amprolium as provided by No. 050604 in Sec.  510.600(c) of this chapter.
    (iv) Amount per ton. Bambermycins, 1 or 4 grams plus carbarsone, 227 
grams (0.025 percent).
    (a) Indications for use. For improved feed efficiency (1 gram per 
ton) or increased rate of weight gain (4 grams per ton); as an aid in 
the prevention of blackhead.
    (b) Limitations. Feed continuously 2 weeks before blackhead is 
expected and continue as long as prevention is needed; withdraw 5 days 
before slaughter; use as sole source of organic arsenic; carbarsone by 
046573 in Sec.  510.600(c) of this chapter.
    (4) Cattle--(i) Amount per ton. 1 to 4 grams.
    (a) Indications for use. For increased rate of weight gain and 
improved feed efficiency.
    (b) Limitations. Feed only to cattle being fed in confinement for 
slaughter. Feed continuously in a Type C medicated feed at a rate of 10 
to 20 milligrams of bambermycins per head per day. Liquid Type B feeds 
containing bambermycins may be used in the preparation of dry complete 
ration Type C feeds.
    (ii) Amount per ton. 2 to 40 grams.
    (a) Indications for use. For increased rate of weight gain.
    (b) Limitations. Feed continuously to pasture cattle (slaughter, 
stocker, and feeder cattle, and dairy and beef replacement heifers) at a 
rate of 10 to 20 milligrams of bambermycins per head per day in at least 
1 pound and not more than 10 pounds of Type C medicated feed.
    (iii) 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.

----------------------------------------------------------------------------------------------------------------
                          Ingredient                             International Feed No.          Percent
----------------------------------------------------------------------------------------------------------------
Deflorinated phosphate (20.5% calcium, 18.5% phosphorus)                       6-01-080                    42.50
Sodium chloride (salt)                                                         6-04-152                    20.10
Calcium carbonate (38% calcium)                                                6-01-069                    15.24
Corn distillers dried grains w/solubles                                        5-28-236                     9.57
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 g/lb)                                         .........                     0.60
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

[[Page 390]]

 
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). Feed a nonmedicated commercial mineral 
product for 6 weeks to stabilize consumption between 2.66 and 5.33 
ounces per head per day. Feed continuously to provide 10- to 20-
milligrams bambermycins per head per day. Each use of this free-choice 
Type C medicated feed must be the subject of an approved Form FDA 1900 
as required by 21 CFR 510.455.
    (iv) Use free-choice Type C medicated feeds for pasture cattle 
(slaughter, stocker, and feeder cattle, and dairy and beef replacement 
heifers) as follows:
    (a) Amount. Feed continuously to provide 10 to 20 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.
    (5) Bambermycins may be used in combination with:
    (i) Diclazuril as in Sec.  558.198.
    (ii) Halofuginone as in Sec.  558.265.
    (iii) Monensin as in Sec.  558.355.
    (iv) Narasin alone or with nicarbazin or roxarsone as in Sec.  
558.363.
    (v) Nicarbazin as in Sec.  558.366.

[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 on GPO Access.



Sec.  558.105  [Reserved]



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).
    (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

[[Page 391]]

feeds containing less than 15 percent crude protein.

[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]



Sec.  558.120  Carbarsone (not U.S.P.).

    (a) Approvals. Type A medicated articles: (1) 37.5 percent to 046573 
in Sec.  510.600(c) of this chapter.
    (2) 25 percent carbarsone and 5 grams per pound bacitracin (as 
bacitracin methylene disalicylate) to 046573 in Sec.  510.600(c) of this 
chapter.
    (b) Related tolerances. See Sec.  556.60 of this chapter.
    (c) [Reserved]
    (d) Conditions of use. (1) It is used for turkeys as follows:
    (i) Grams per ton. 227 to 340.5 (0.025 to 0.0375 percent).
    (a) Indications for use. As an aid in the prevention of blackhead.
    (b) Limitations. Feed continuously beginning 2 weeks before 
blackhead is expected and continue as long as prevention is needed; 
withdraw 5 days before slaughter; as sole source of organic arsenic.
    (ii) Grams per ton. 227 to 340.5 (0.025 to 0.0375 percent) 
carbarsone plus 10 grams per ton bacitracin from bacitracin methylene 
disalicylate.
    (a) Indications for use. As an aid in the prevention of blackhead; 
for increased rate of weight gain.
    (b) Limitations. Feed continuously beginning 2 weeks before 
blackhead is expected and continue as long as prevention is needed; 
withdraw 5 days before slaughter; as sole source of organic arsenic.
    (iii) Grams per ton. 227 to 340.5 (0.025 to 0.0375 percent) 
carbarsone plus 4 to 45 grams per ton bacitracin from bacitracin zinc.
    (a) Indications for use. As an aid in the prevention of blackhead, 
increased rate of weight gain, and improved feed efficiency.
    (b) Limitations. Feed continuously as sole ration. Withdraw 5 days 
before slaughter. As sole source of organic arsenic; as bacitracin zinc 
provided by No. 046573 in Sec.  510.600(c) of this chapter.
    (2) Carbarsone (not U.S.P.) may be used in accordance with the 
provisions of this section in the combinations provided as follows:
    (i) Zoalene in accordance with Sec.  558.680.
    (ii) Amprolium as in Sec.  558.55.
    (iii) Bambermycins as in Sec.  558.95.

[41 FR 10995, Mar. 15, 1976, as amended at 42 FR 18617, Apr. 8, 1977; 46 
FR 46797, Sept. 22, 1981; 48 FR 2758, Jan. 21, 1983; 51 FR 7396, Mar. 3, 
1986; 52 FR 2687, Jan. 26, 1987; 53 FR 20843, June 7, 1988; 57 FR 7652, 
Mar. 4, 1992; 61 FR 515, Jan. 8, 1996; 61 FR 18082, Apr. 24, 1996; 62 FR 
61011, Nov. 14, 1997; 63 FR 27845, May 21, 1998; 66 FR 46706, Sept. 7, 
2001]



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) Approvals. See sponsors in Sec.  510.600(c) of this chapter for 
use as in paragraph (e) of this section.
    (1) Nos. 046573, 053389, and 066104: 50 to 100 grams per pound (g/
lb) of Type A medicated article.
    (2) No. 017519: 50 g/lb of Type A medicated article.
    (c) Related tolerances. See Sec.  556.150 of this chapter.
    (d) Special considerations. (1) 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.''
    (2) 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.
    (3) When manufactured for use as in paragraph (e)(5)(iv) 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:

[[Page 392]]



----------------------------------------------------------------------------------------------------------------
Chlortetracycline amount           Indications for use                      Limitations               Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 10 to 50 g/ton        Chickens: For increased rate of        ................................  046573.
                           weight gain and improved feed         ................................  .............
                           efficiency.                           Do not feed to chickens           017519,
                                                                  producing eggs for human         046573,
                                                                  consumption.                     053389,
                                                                                                   066104.
----------------------------------------------------------------------------------------------------------------
(ii) 100 to 200 g/ton     Chickens: For control of infectious    1. Feed continuously for 7 to 14  046573.
                           synovitis caused by Mycoplasma         d.                               .............
                           synoviae susceptible to               ................................  017519,
                           chlortetracycline.                    2. Feed continuously for 7 to 14  046573,
                                                                  d; do not feed to chickens       053389,
                                                                  producing eggs for human         066104.
                                                                  consumption.
----------------------------------------------------------------------------------------------------------------
(iii) 200 to 400 g/ton    Chickens: For the control of chronic   1. Feed continuously for 7 to 14  046573.
                           respiratory disease (CRD) and air      d.                               .............
                           sac infection caused by M.            ................................  017519,
                           gallisepticum and Escherichia coli    2. Feed continuously for 7 to 14  046573,
                           susceptible to chlortetracycline.      d; do not feed to chickens       053389,
                                                                  producing eggs for human         066104.
                                                                  consumption.
----------------------------------------------------------------------------------------------------------------
(iv) 500 g/ton            Chickens: For the reduction of         1. Feed for 5 d.                  046573.
                           mortality due to E. coli infections   ................................  .............
                           susceptible to chlortetracycline.     2. Feed for 5 d; do not feed to   017519,
                                                                  chickens producing eggs for      046573,
                                                                  human consumption.               053389,
                                                                                                   066104.
----------------------------------------------------------------------------------------------------------------

    (2) Turkeys. It is used as follows:

----------------------------------------------------------------------------------------------------------------
Chlortetracycline amount           Indications for use                      Limitations               Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 10 to 50 g/ton        Growing turkeys: For increased rate    Do not feed to turkeys producing  017519,
                           of weight gain and improved feed       eggs for human consumption.      046573,
                           efficiency.                                                             053389,
                                                                                                   066104.
----------------------------------------------------------------------------------------------------------------
(ii) 200 g/ton            Turkeys: For control of infectious     Feed continuously for 7 to 14 d;  017519,
                           synovitis caused by M. synoviae        do not feed to turkeys           046573,
                           susceptible to chlortetracycline.      producing eggs for human         053389,
                                                                  consumption.                     066104.
----------------------------------------------------------------------------------------------------------------
(iii) 400 g/ton           1. Turkeys: For control of             Feed continuously for 7 to 14 d;  017519,
                           hexamitiasis caused by Hexamita        do not feed to turkeys           046573,
                           meleagrides susceptible to             producing eggs for human         053389,
                           chlortetracycline.                     consumption.                     066104.
                          .....................................  ................................  .............
                          2. Turkey poults not over 4 weeks of                                     017519,
                           age: For reduction of mortality due                                     046573,
                           to paratyphoid caused by Salmonella                                     053389,
                           typhimurium susceptible to                                              066104.
                           chlortetracycline.
----------------------------------------------------------------------------------------------------------------
(iv) 25 mg/lb of body     Turkeys: For control of complicating   Feed continuously for 7 to 14 d;  017519,
 weight                    bacterial organisms associated with    do not feed to turkeys           046573,
                           bluecomb (transmissible enteritis;     producing eggs for human         053389,
                           coronaviral enteritis) susceptible     consumption.                     066104.
                           to chlortetracycline.
----------------------------------------------------------------------------------------------------------------

    (3) Swine. It is used as follows:

----------------------------------------------------------------------------------------------------------------
Chlortetracycline amount           Indications for use                      Limitations               Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 10 to 50 g/ton        Growing swine: For increased rate of   ................................  017519,
                           weight gain and improved feed                                           046573,
                           efficiency.                                                             053389,
                                                                                                   066104.
----------------------------------------------------------------------------------------------------------------

[[Page 393]]

 
(ii) 50 to 100 g/ton      Swine: For reducing the incidence of   ................................  017519,
                           cervical lymphadenitis (jowl                                            046573,
                           abscesses) caused by Group E.                                           053389,
                           Streptococci susceptible to                                             066104.
                           chlortetracycline.
----------------------------------------------------------------------------------------------------------------
(iii) 400 g/ton           Breeding swine: For the control of     Feed continuously for not more    017519,
                           leptospirosis (reducing the            than 14 d.                       046573,
                           incidence of abortion and shedding                                      053389,
                           of leptospirae) caused by Leptospira                                    066104.
                           pomona susceptible to
                           chlortetracycline.
----------------------------------------------------------------------------------------------------------------
(iv) 10 mg/lb of body     1. Swine: For the treatment of         Feed approximately 400 g/t,       017519,
 weight                    bacterial enteritis caused by E.       varying with body weight and     046573,
                           coli and S. choleraesuis and           feed consumption to provide 10   053389,
                           bacterial pneumonia caused by          mg/lb per day. Feed for not      066104.
                           Pasteurella multocida susceptible to   more than 14 d; withdraw 5 d
                           chlortetracycline.                     prior to slaughter for sponsor
                                                                  017519.
                          .....................................  ................................  .............
                          2. Swine: For the control of porcine   Feed for not more than 14 d.      046573.
                           proliferative enteropathies
                           (ileitis) caused by Lawsonia
                           intracellularis susceptible to
                           chlortetracycline.
----------------------------------------------------------------------------------------------------------------

    (4) Cattle. It is used as follows:

----------------------------------------------------------------------------------------------------------------
Chlortetracycline amount           Indications for use                      Limitations               Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 0.1 mg/lb of body     Calves (up to 250 lb): For increased   See paragraph (d)(1) of this      017519,
 weight daily.             rate of weight gain and improved       section.                         046573,
                           feed efficiency.                                                        053389,
                                                                                                   066104.
----------------------------------------------------------------------------------------------------------------
(ii) 0.5 mg/lb of body    Beef cattle (over 700 lb); control of  Withdraw 48 h prior to            017519,
 weight daily.             active infection of anaplasmosis       slaughter. To sponsor No.        046573,
                           caused by Anaplasma marginale          046573: zero withdrawal time.    053389,
                           susceptible to chlortetracycline.      To sponsor No. 053389: 1 d       066104.
                                                                  withdrawal time.
----------------------------------------------------------------------------------------------------------------
(iii) 0.5 to 2.0 mg/lb    Beef cattle and nonlactating dairy     In free-choice cattle feeds such  046573.
 of body weight daily.     cattle: As an aid in the control of    as feed blocks or salt-mineral
                           active infection of anaplsmosis        mixes manufactured from
                           caused by A. marginale susceptible     approved Type A articles. See
                           to chlortetracycline.                  paragraph (d)(2) of this
                                                                  section.
----------------------------------------------------------------------------------------------------------------
(iv) 10 mg/lb of body     1. Calves, beef and nonlactating       Feed approximately 400 g/ton,     017519,
 weight daily.             dairy cattle; treatment of bacterial   varying with body weight and     046573,
                           enteritis caused by E. coli and        feed consumption to provide 10   053389,
                           bacterial pneumonia caused by P.       mg/lb per day. Treat for not     066104.
                           multocida organisms susceptible to     more than 5 d; in feed
                           chlortetracycline.                     including milk replacers;
                                                                  withdraw 10 d prior to
                                                                  slaughter. To sponsor No.
                                                                  053389: 1 d withdrawal time. To
                                                                  sponsor No. 046573: zero
                                                                  withdrawal time. See paragraph
                                                                  (d)(1) of this section.
                          .....................................  ................................  .............
                          2. Calves (up to 250 lb): For the      See paragraph (d)(1) of this      017519,
                           treatment of bacterial enteritis       section.                         046573,
                           caused by E. coli susceptible to                                        053389,
                           chlortetracycline.                                                      066104.
----------------------------------------------------------------------------------------------------------------
(v) 4,000 to 20,000 g/    Calves, beef and nonlactating dairy    As a top dress, varying with      046573.
 ton                       cattle; treatment of bacterial         body weight and feed
                           enteritis caused by E. coli and        consumption, to provide 10 mg/
                           bacterial pneumonia caused by P.       lb per day. Treat for not more
                           multocida organisms susceptible to     than 5 days. See paragraph
                           chlortetracycline.                     (d)(1) of this section.
----------------------------------------------------------------------------------------------------------------
(vi) 25 to 70 mg/head/    Calves (250 to 400 lb): For increased  See paragraph (d)(1) of this      017519,
 day                       rate of weight gain and improved       section.                         046573,
                           feed efficiency.                                                        053389,
                                                                                                   066104.
----------------------------------------------------------------------------------------------------------------

[[Page 394]]

 
(vii) 70 mg/head/day      Growing cattle (over 400 lb): For      See paragraph (d)(1) of this      017519,
                           increased rate of weight gain,         section.                         046573,
                           improved feed efficiency, and                                           053389,
                           reduction of liver condemnation due                                     066104.
                           to liver abscesses.
----------------------------------------------------------------------------------------------------------------
(viii) 350 mg/head/day    1. Beef cattle: For control of         Withdraw 48 h prior to            017519,
                           bacterial pneumonia associated with    slaughter. For sponsor 046573:    046573,
                           shipping fever complex caused by       zero withdrawal time. For         053389,
                           Pasteurellaspp. susceptible to         sponsor 053389: 1 d withdrawal    066104.
                           chlortetracycline.                     time.
                          .....................................  ................................  .............
                          2. Beef cattle (under 700 lb): For     Withdraw 48 h prior to            017519,
                           control of active infection of         slaughter. For sponsor 046573:   046573,
                           anaplasmosis caused by A. marginale    zero withdrawal time. For        053389,
                           susceptible to chlortetracycline.      sponsor 053389: 1 d withdrawal   066104.
                                                                  time.
----------------------------------------------------------------------------------------------------------------

    (5) Minor species. It is used as follows:

----------------------------------------------------------------------------------------------------------------
Chlortetracycline amount           Indications for use                      Limitations               Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 20 to 50 g/ton        Growing sheep; increased rate of       ................................  046573,
                           weight gain and improved feed                                           053389,
                           efficiency.                                                             066104.
----------------------------------------------------------------------------------------------------------------
(ii) 80 mg/head/day       Breeding sheep; reducing the           ................................  046573,
                           incidence of (vibrionic) abortion                                       053389,
                           caused by Campylobacter fetus                                           066104.
                           infection susceptible to
                           chlortetracycline.
----------------------------------------------------------------------------------------------------------------
(iii) 200 to 400 g/ton    Ducks: For the control and treatment   Feed in complete ration to        046573.
                           of fowl cholera caused by P.           provide from 8 to 28 mg/lb of
                           multocida susceptible to               body weight per day depending
                           chlortetracycline.                     upon age and severity of
                                                                  disease, for not more than 21
                                                                  d. Do not feed to ducks
                                                                  producing eggs for human
                                                                  consumption.
----------------------------------------------------------------------------------------------------------------
(iv) 10 mg/g of finished  Psittacine birds (cockatoos, macaws,   Feed continuously for 45 d; each  046573.
 feed daily.               and parrots) suspected or known to     bird should consume daily an
                           be infected with psittacosis caused    amount of medicated feed equal
                           by Chlamydia psittaci sensitive to     to one fifth of its body
                           chlortetracycline.                     weight.
                                                                 ................................
                                                                 See paragraph (d)(3) of this
                                                                  section.
----------------------------------------------------------------------------------------------------------------

    (6) Chlortetracycline. It may be used in accordance with this 
section in combinations as follows:
    (i) Amprolium in accordance with Sec.  558.55.
    (ii) Amprolium plus ethopabate in accordance with Sec.  558.58.
    (iii) Bacitracin methylene disalicylate in accordance with Sec.  
558.76.
    (iv) Clopidol in accordance with Sec.  558.175.
    (v) Decoquinate in accordance with Sec.  558.195.
    (vi) Hygromycin B in accordance with Sec.  558.274.
    (vii) Laidlomycin in accordance with Sec.  558.305.
    (viii) Monensin in accordance with Sec.  558.355.
    (ix) Robenidine hydrochloride in accordance with Sec.  558.515.
    (x) Roxarsone in accordance with Sec.  558.530.
    (xi) Salinomycin alone or with roxarsone in accordance with Sec.  
558.550.
    (xii) Tiamulin in accordance with Sec.  558.600.
    (xiii) Zoalene in accordance with Sec.  558.680.

[41 FR 10995, Mar. 15, 1976]

    Editorial Note: For Federal Register citations affecting Sec.  
558.128, see the List of Sections Affected, which appears in the Finding 
Aids section of the printed volume and on GPO Access.

[[Page 395]]



Sec.  558.140   Chlortetracycline and sulfamethazine.

    (a) Approvals. Type A medicated articles: 35 grams of 
chlortetracycline per pound with 7.7 percent (35 grams) of 
sulfamethazine to 046573 in Sec.  510.600(c) of this chapter.
    (b) Related tolerances. See Sec. Sec.  556.150 and 556.670 of this 
chapter.
    (c) It is used in feed for beef cattle as follows:
    (1) Amount per head per day. Chlortetracycline, 350 milligrams plus 
sulfamethazine, 350 milligrams.
    (2) Indications for use. Aid in the maintenance of weight gains in 
the presence of respiratory disease such as shipping fever.
    (3) Limitations. Feed for 28 days; withdraw 7 days prior to 
slaughter.

[61 FR 35954, July 9, 1996, as amended at 64 FR 15684, Apr. 1, 1999; 66 
FR 46706, Sept. 7, 2001]



Sec.  558.145  Chlortetracycline, procaine penicillin, and sulfamethazine.

    (a) Approvals. Type A medicated articles: (1) 20 grams of 
chlortetracycline per pound, 4.4 percent (20 grams) of sulfamethazine, 
and procaine penicillin equivalent in activity to 10 grams of penicillin 
per pound to 046573 in Sec.  510.600(c) of this chapter.
    (2) 40 grams of chlortetracycline per pound, 8.8 percent of 
sulfamethazine, and penicillin procaine equivalent in activity to 20 
grams of penicillin per pound to 046573 in Sec.  510.600(c) of this 
chapter.
    (b) Specifications. (1) The antibiotic substance refers to the 
antibiotic or feed-grade antibiotic.
    (2) The antibiotic activities are expressed in terms of the 
appropriate antibiotic standards.
    (3) Type C medicated feed contains in each ton, 100 grams of 
chlortetracycline, 50 grams of penicillin as procaine penicillin, and 
100 grams of sulfamethazine.
    (c) Related tolerances. See Sec. Sec.  556.150, 556.510, and 556.670 
of this chapter.
    (d) Conditions of use. (1) It is administered to swine in a Type C 
feed for reduction of the incidence of cervical abscesses; treatment of 
bacterial swine enteritis (salmonellosis or necrotic enteritis caused by 
Salmonella choleraesuis and vibrionic dysentery); prevention of these 
diseases during times of stress; maintenance of weight gains in the 
presence of atrophic rhinitis; growth promotion and increased feed 
efficiency in swine weighing up to 75 pounds.
    (2) Withdraw 15 days prior to slaughter.

[40 FR 13959, Mar. 27, 1975, as amended at 43 FR 19385, May 5, 1978; 47 
FR 39814, Sept. 10, 1982; 48 FR 30615, July 5, 1983; 51 FR 7396, Mar. 3, 
1986; 52 FR 2684, Jan. 26, 1987; 56 FR 14019, Apr. 5, 1991; 61 FR 18082, 
Apr. 24, 1996; 62 FR 14300, Mar. 26, 1997; 63 FR 27845, May 21, 1998; 66 
FR 46706, Sept. 7, 2001]



Sec.  558.155  Chlortetracycline, sulfathiazole, penicillin.

    (a) Approvals. Type A medicated articles: (1) 20 grams of 
chlortetracycline hydrochloride, 4.4 percent (20 grams) sulfathiazole, 
and procaine penicillin equivalent to 10 grams of penicillin per pound 
to No. 046573 in Sec.  510.600(c) of this chapter.
    (2) 40 grams of chlortetracycline hydrochloride, 8.8 percent (40 
grams) sulfathiazole and procaine penicillin equivalent in activity to 
20 grams of penicillin per pound to No. 046573 in Sec.  510.600(c) of 
this chapter.
    (b) Specifications. (1) The antibiotic substance refers to the 
antibiotic or feed-grade antibiotic.
    (2) The antibiotic activities are expressed in terms of the 
appropriate antibiotic standards.
    (c) Related tolerances. See Sec. Sec.  556.150, 556.510, and 556.690 
of this chapter.
    (d) Conditions of use. It is used for swine as follows:
    (1) Amount per ton. Chlortetracycline, 100 grams plus penicillin, 50 
grams plus sulfathiazole, 100 grams.
    (2) Indications for use. For reduction of incidence of cervical 
abscesses. Treatment of bacterial enteritis (salmonellosis or necrotic 
enteritis caused by Salmonella choleraesuis and vibrionic dysentery). 
Maintenance of weight gains in the presence of atrophic rhinitis. Swine 
10 pounds of body weight to 6 weeks post-weaning: Increased rate of 
weight gain and improved feed efficiency. Swine 6 to 16 weeks post-
weaning: Increased rate of weight gain.
    (3) Limitations. For swine raised in confinement (dry-lot) or on 
limited pasture. Feed as sole ration. Withdraw 7 days prior to 
slaughter.

[[Page 396]]



      Minimum Amount of Type C Feed Which the Animal Should Consume
------------------------------------------------------------------------
                                                                Minimum
                                                 Approximate    desired
                  Type of feed                   body weight  daily feed
                                                  in pounds    intake in
                                                                pounds
------------------------------------------------------------------------
Prestarter (up to 6 weeks postweaning).........           20           1
Starter (up to 6 weeks postweaning)............           50      1\1/2\
Grower (6-16 weeks postweaning)................           80           2
Finisher (6-16 weeks postweaning)..............          150           3
------------------------------------------------------------------------


[40 FR 13959, Mar. 27, 1975, as amended at 51 FR 7397, Mar. 3, 1986; 51 
FR 28547, Aug. 8, 1986; 52 FR 2684, Jan. 26, 1987; 61 FR 2415, Jan. 26, 
1996; 62 FR 35077, June 30, 1997; 62 FR 67725, Dec. 30, 1997; 63 FR 
11599, Mar. 10, 1998; 66 FR 46706, Sept. 7, 2001; 67 FR 21171, Apr. 30, 
2002]



Sec.  558.175  Clopidol.

    (a) Approvals. Type A medicated articles: (1) 25 percent to 011526 
in Sec.  510.600(c) of this chapter.
    (2) 25 percent of clopidol, 10 percent of roxarsone, and 4, 10. 15, 
or 25 grams of bacitracin methylene disalicylate per pound to 011526 in 
Sec.  510.600(c) of this chapter.
    (b) Related tolerances. See Sec.  556.160 of this chapter.
    (c) [Reserved]
    (d) Conditions of use. It is used as follows:
    (1) Broiler chickens--(i) Amount per ton. Clopidol 113.5 grams 
(0.0125 percent).
    (a) Indications for use. Aid in the prevention of coccidiosis caused 
by E. tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and 
E. mivati.
    (b) Limitations. Do not feed to chickens over 16 weeks of age.
    (ii) Amount per ton. Clopidol, 113.5 grams (0.0125 percent) plus 
roxarsone, 45.4 grams (0.005 percent).
    (a) Indications for use. Aid in the prevention of coccidiosis caused 
by E. tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and 
E. mivati; growth promotion and feed efficiency; improved pigmentation.
    (b) Limitations. Do not feed to chickens over 16 weeks of age; 
withdraw 5 days before slaughter; as sole source of organic arsenic.
    (iii) Amount per ton. Clopidol, 113.5 grams (0.0125 percent) plus 
roxarsone, 45.4 grams (0.005 percent) plus bacitracin, 4-25 grams.
    (a) Indications for use. Aid in the prevention of coccidiosis caused 
by E. tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and 
E. mivati; growth promotion and feed efficiency; improved pigmentation; 
increased rate of weight gain.
    (b) Limitations. Do not feed to chickens over 16 weeks of age; 
withdraw 5 days before slaughter; as sole source of organic arsenic; as 
bacitracin methylene disalicylate, provided by No. 046573 in Sec.  
510.600(c) of this chapter; or as zinc bacitracin provided by Nos. 
046573 and 063238 in Sec.  510.600(c) of this chapter.
    (iv) Amount per ton. Clopidol, 113.5 grams (0.0125%) plus zinc 
bacitracin, 5 to 25 grams.
    (a) Indications for use. For increased rate of weight gain and 
improved feed efficiency; aid in the prevention of coccidiosis caused by 
E. tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. 
mivati.
    (b) Limitations. Feed continuously as sole ration. Zinc bacitracin 
as provided by Nos. 046573 and 063238 of Sec.  510.600(c) of this 
chapter.
    (v) Amount per ton. Clopidol, 113.5 grams (0.0125 percent) plus 
bacitracin methylene disalicylate, 4 to 50 grams per ton.
    (a) Indications for use. For increased rate of weight gain; to aid 
in the prevention of coccidiosis caused by E. tenella, E. necatrix, E. 
acervulina, E. maxima, E. mivati, and E. brunetti.
    (b) Limitations. Feed continuously as the sole ration from the time 
chicks are placed in floor pens until slaughter. Do not feed to chickens 
over 16 weeks of age. Bacitracin methylene disalicylate as provided by 
No. 046573 in Sec.  510.600(c) of this chapter.
    (vi) Amount per ton. Clopidol, 113.5 grams (0.0125 percent) plus 
lincomycin, 2-4 grams.
    (a) Indications for use. Aid in the prevention of coccidiosis caused 
by E. tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and 
E. mivati; increase in rate of weight gain and improved feed efficiency.
    (b) Limitations. As lincomycin hydrochloride monohydrate; do not 
feed to chickens over 16 weeks of age.

[[Page 397]]

    (2) Broiler chickens and replacement chickens--(i) Amount per ton. 
Clopidol, 113.5 or 227 grams (0.0125 or 0.025 percent).
    (a) Indications for use. Aid in the prevention of coccidiosis caused 
by E. tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and 
E. mivati.
    (b) Limitations. Feed up to 16 weeks of age if intended for use as 
caged layers; feed continuously as the sole ration; withdraw 5 days 
before slaughter if given at the level of 0.025 percent in feed or 
reduce level to 0.0125 percent 5 days before slaughter.
    (ii) Amount per ton. Clopidol, 113.5 grams (0.0125 percent) plus 
chlortetracycline 100 to 200 grams.
    (a) Indications for use. Aid in the prevention of coccidiosis caused 
by E. tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and 
E. mivati; control of infectious synovitis caused by Mycoplasma synoviae 
susceptible to chlortetracycline.
    (b) Limitations. Feed continuously as sole ration from the time 
chicks are placed in floor pens for 7 to 14 days.
    (3) [Reserved]
    (4) Replacement chickens--(i) Amount per ton. Clopidol 113.5 grams 
(0.0125 percent).
    (a) Indications for use. Aid in the prevention of coccidiosis caused 
by E. tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and 
E. mivati.
    (b) Limitations. For replacement chickens intended for use as caged 
layers; do not feed to chickens over 16 weeks of age.
    (ii) Amount per ton. Clopidol 113.5 grams (0.0125 percent) plus 
roxarsone 45.4 grams (0.005 percent).
    (a) Indications for use. Aid in the prevention of coccidiosis caused 
by E. tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and 
E. mivati; growth promotion and feed efficiency; improving pigmentation.
    (b) Limitations. For replacement chickens intended for use as caged 
layers; do not feed to chickens over 16 weeks of age; withdraw 5 days 
before slaughter; as sole source of organic arsenic.
    (5) Turkeys--(i) Amount per ton. Clopidol 113.5 or 227 grams (0.0125 
or 0.025 percent).
    (ii) Indications for use. Aid in the prevention of leucocytozoonosis 
caused by Leucocytozoon smithi.
    (iii) Limitations. For turkeys grown for meat purposes only; to be 
administered continuously in feed at 0.0125 or 0.025 percent clopidol as 
the sole ration depending upon management practices, degree of exposure, 
and amount of feed eaten; withdraw medication 5 days before slaughter.

[40 FR 13959, Mar. 27, 1975, as amended at 40 FR 31935, July 30, 1975; 
40 FR 52723, Nov. 12, 1975; 41 FR 1062, Jan. 6, 1976; 41 FR 53002, Dec. 
3, 1976; 44 FR 20676, Apr. 6, 1979; 51 FR 7397, Mar. 3, 1986; 52 FR 
2684, Jan. 26, 1987; 53 FR 20843, June 7, 1988; 54 FR 6518, Feb. 13, 
1989; 61 FR 35954, July 9, 1996; 62 FR 61626, Nov. 19, 1997; 62 FR 
61912, Nov. 20, 1997; 62 FR 62243, Nov. 21, 1997; 63 FR 17948, Apr. 13, 
1998; 63 FR 27845, May 21, 1998]



Sec.  558.185  Coumaphos.

    (a) Approvals. Type A medicated articles:
    (1) [Reserved]
    (2) 1.12 and 11.2 percent to 017800 in Sec.  510.600(c) of this 
chapter for use as in paragraph (d)(1)(ii) of this section.
    (b) Special considerations. Adequate directions and warnings for use 
must be given and shall include a statement that coumaphos is a 
cholinesterase inhibitor and that animals being treated with coumaphos 
should not be exposed during or within a few days before or after 
treatment to any other cholinesterase-inhibiting drugs, insecticides, 
pesticides, or chemicals.
    (c) Related tolerances. See 40 CFR 180.189.
    (d) Conditions of use. It is used as follows:
    (1) Beef and dairy cattle--(i) Amount. Coumaphos 0.00012 lb. (0.054 
gram) per 100 lb. body weight per day.
    (a) Indications for use. As an aid in the reduction of fecal 
breeding flies through control of fly larvae.
    (b) Limitations. Feed for the duration of fly season in a Type C 
feed containing 0.0033 percent or in a feed Type B feed containing not 
over 0.0066 percent coumaphos; do not feed to animals less than 3 months 
old; not for use in pelleted feeds.
    (ii) Amount. Coumaphos, 0.0002 lb. (0.091 gram) per 100 lb. body 
weight per day.

[[Page 398]]

    (a) Indications for use. Control of gastrointestinal roundworms 
(Haemonchus spp., Ostertagia spp., Cooperia spp., Nematodirus spp., 
Trichostrongylus spp.).
    (b) Limitations. Feed 0.0002 lb. (0.091 gram) per 100 lb. body 
weight per day for 6 consecutive days in the normal grain ration to 
which the animals are accustomed but not in rations containing more than 
0.1 percent coumaphos; do not feed to animals less than 3 months old; do 
not feed to sick animals or animals under stress, such as those just 
shipped, dehorned, castrated, or weaned within the last 3 weeks; do not 
feed in conjunction with oral drenches or with feeds containing 
phenothiazine. Should conditions warrant, repeat treatment at 30-day 
intervals.
    (2) Laying chickens--(i) Amount. Coumaphos 27.2 grams per ton (0.003 
percent).
    (ii) Indications for use. For control of capillary worm (Capillaria 
obsignata) and as an aid in control of common round worm (Ascaridia 
galli) and cecal worm (Heterakis gallinae).
    (iii) Limitations. In Type C feed; administer continuously as the 
total feed ration for 14 days; when reinfection occurs, treatment may be 
repeated but not sooner than 3 weeks after the end of the previous 
treatment; do not feed to chickens within 10 days of vaccination or 
other conditions of stress; treatment of colored breeds of commercial 
layers should be avoided while in production since these breeds appear 
to be more sensitive to coumaphos than white breeds; as sole medication; 
medications in general should be avoided while birds are approaching 
peak production; such interruption of normal feeding practices may upset 
the flock and lower egg production; diagnosis by competent personnel is 
essential; flock condition and production records should be carefully 
evaluated prior to treatment.
    (3) Replacement pullets--(i) Amount. Coumaphos 36.3 grams per ton 
(0.004 percent).
    (ii) Indications for use. For control of capillary worm (Capillaria 
obsignata) and as an aid in control of common roundworm (Ascaridia 
galli) and cecal worm (Heterakis gallinae).
    (iii) Limitations. In Type C feed; administer before the onset of 
production; diagnosis by competent personnel is essential; administer 
continuously as total feed ration for from 10 to 14 days; do not feed to 
chickens under 8 weeks of age nor within 10 days of vaccination or other 
conditions of stress; if 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; as sole medication; if reinfection occurs after production 
begins, repeat treatment as recommended for laying flocks.

[40 FR 13959, Mar. 27, 1975, as amended at 42 FR 1463, Jan. 7, 1977; 51 
FR 7397, Mar. 3, 1986; 52 FR 2684, Jan. 26, 1987; 61 FR 34729, July 3, 
1996]



Sec.  558.195  Decoquinate.

    (a) Specifications. Type A medicated article containing 6 percent 
decoquinate.
    (b) Approvals. See No. 046573 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.

[[Page 399]]



------------------------------------------------------------------------
 Decoquinate   Combination  Indications
in grams/ton  in grams/ton    for use    Limitations        Sponsor
------------------------------------------------------------------------
(i) 27.2      ............  Broiler      Do not feed             046573
                             chickens:    to laying
                             For          chickens.
                             prevention
                             of
                             coccidiosi
                             s caused
                             by Eimeria
                             tenella,
                             E.
                             necatrix,
                             E.
                             mivati,E.
                             acervulina
                             , E.
                             maxima,
                             and E.
                             brunetti.
(ii) 27.2     Bacitracin    Broiler      Feed                    046573
               methylene     chickens:    continuous
               disalicylat   As in        ly as sole
               e 4 to 50     paragraph    ration; do
                             (e)(1)(i)    not feed
                             of this      to laying
                             section;     chickens.
                             and for      Bacitracin
                             increased    methylene
                             rate of      disalicyla
                             weight       te as
                             gain and     provided
                             improved     by No.
                             feed         046573 in
                             efficiency   Sec.
                             .            510.600(c)
                                          of this
                                          chapter.
(iii) 27.2    Bacitracin    Broiler      Feed                    046573
               zinc 10 to    chickens:    continuous
               50            As in        ly as sole
                             paragraph    ration; do
                             (e)(1)(ii)   not feed
                             of this      to laying
                             section.     chickens.
                                          Bacitracin
                                          zinc as
                                          provided
                                          by No.
                                          046573 in
                                          Sec.
                                          510.600(c)
                                          of this
                                          chapter.
(iv) 27.2     Bacitracin    Broiler      Do not feed             046573
               zinc 12 to    chickens:    to laying
               50 plus       As in        chickens;
               roxarsone     paragraph    withdraw 5
               11 to 45      (e)(1)(ii)   days
                             of this      before
                             section.     slaughter;
                                          as sole
                                          source of
                                          organic
                                          arsenic.
              ............  ...........  Bacitracin   ..................
                                          zinc and
                                          roxarsone
                                          as
                                          provided
                                          by No.
                                          046573 in
                                          Sec.
                                          510.600(c)
                                          of this
                                          chapter.
(v) 27.2      Bacitracin    Broiler      Feed                    046573
               methylene     chickens:    continuous
               disalicylat   As in        ly as sole
               e 50 and      paragraph    ration; do
               roxarsone     (e)(1)(ii)   not feed
               22.7 to       of this      to laying
               45.4          section;     chickens;
                             as an aid    withdraw 5
                             in the       days
                             prevention   before
                             of           slaughter.
                             necrotic     Not for
                             enteritis    use in
                             caused or    breeder
                             complicate   chickens.
                             d by         Use as
                             Clostridiu   sole
                             m spp. or    source of
                             other        organic
                             organisms    arsenic.
                             susceptibl   Poultry
                             e to         should
                             bacitracin   have
                             ; and for    access to
                             improved     drinking
                             pigmentati   water at
                             on.          all times.
                                          Drug
                                          overdosage
                                          or lack of
                                          drinking
                                          water may
                                          result in
                                          leg
                                          weakness
                                          or
                                          paralysis.
                                          Bacitracin
                                          methylene
                                          disalicyla
                                          te and
                                          roxarsone
                                          as
                                          provided
                                          by No.
                                          046573 in
                                          Sec.
                                          510.600(c)
                                          of this
                                          chapter.
(vi) 27.2     Chlortetracy  Chickens:    Feed                    046573
               cline 100     As in        continuous
               to 200        paragraph    ly for 7
                             (e)(1)(i)    to 14
                             of this      days; do
                             section;     not feed
                             control of   to
                             infectious   chickens
                             synovitis    producing
                             caused by    eggs for
                             Mycoplasma   human
                             synoviae     consumptio
                             susceptibl   n.
                             e to
                             chlortetra
                             cycline.
(vii) 27.2    Chlortetracy  Chickens:    As in                   046573
               cline 200     As in        paragraph
               to 400        paragraph    (e)(1)(vi)
                             (e)(1)(i)    of this
                             of this      section.
                             section;
                             and for
                             control of
                             chronic
                             respirator
                             y disease
                             (CRD) and
                             air sac
                             infection
                             caused by
                             M.
                             gallisepti
                             cum and
                             Escherichi
                             a coli
                             susceptibl
                             e to
                             chlortetra
                             cycline.
(viii) 27.2   Lincomycin 2  Broiler      Feed as                 000009
                             chickens:    sole                   046573
                             As in        ration; do
                             paragraph    not feed
                             (e)(1)(ii)   to laying
                             of this      chickens;
                             section.     lincomycin
                                          provided
                                          by No.
                                          000009 in
                                          Sec.
                                          510.600(c)
                                          of this
                                          chapter.
(ix) 27.2     Roxarsone     Broiler      Do not feed             046573
               45.4          chickens:    to laying
                             As in        chickens;
                             paragraph    withdraw 5
                             (e)(1)(ii)   days
                             of this      before
                             section;     slaughter;
                             and for      as sole
                             improving    source of
                             pigmentati   organic
                             on.          arsenic.
------------------------------------------------------------------------

    (2) Cattle.

[[Page 400]]



------------------------------------------------------------------------
 Decoquinate   Combination  Indications
in grams/ton  in grams/ton    for use    Limitations        Sponsor
------------------------------------------------------------------------
(i) 12.9 to   ............  Cattle       Feed Type C             046573
 90.8                        (including   feed or
                             ruminating   milk
                             and          replacer
                             nonruminat   at a rate
                             ing calves   to provide
                             and veal     22.7
                             calves):     milligrams
                             For          (mg) per
                             prevention   100 pounds
                             of           (lb) of
                             coccidiosi   body
                             s caused     weight
                             by Eimeria   (0.5 mg/
                             bovis and    kilogram
                             E.           (kg)) per
                             zuernii.     day. Feed
                                          at least
                                          28 days
                                          during
                                          periods of
                                          exposure
                                          to
                                          coccidiosi
                                          s or when
                                          it is
                                          likely to
                                          be a
                                          hazard. Do
                                          not feed
                                          to cows
                                          producing
                                          milk for
                                          food. May
                                          be
                                          prepared
                                          from dry
                                          or liquid
                                          Type B
                                          feed
                                          containing
                                          0.0125 to
                                          0.5
                                          percent
                                          decoquinat
                                          e. See
                                          paragraph
                                          (d)(3) of
                                          this
                                          section.
(ii) 90.9 to  ............  Cattle       Feed as a               046573
 535.7                       (including   top dress
                             ruminating   at a rate
                             and          to provide
                             nonruminat   22.7 mg
                             ing calves   per 100 lb
                             and veal     of body
                             calves):     weight
                             As in        (0.5 mg/
                             paragraph    kg) per
                             (e)(2)(i)    day. Feed
                             of this      at least
                             section.     28 days
                                          during
                                          periods of
                                          exposure
                                          to
                                          coccidiosi
                                          s or when
                                          it is
                                          likely to
                                          be a
                                          hazard. Do
                                          not feed
                                          to cows
                                          producing
                                          milk for
                                          food. May
                                          be
                                          prepared
                                          from dry
                                          or liquid
                                          Type B
                                          feed
                                          containing
                                          0.0125 to
                                          0.5
                                          percent
                                          decoquinat
                                          e. See
                                          paragraph
                                          (d)(3) of
                                          this
                                          section.
(iii) 13.6    Chlortetracy  Calves,      Feed Type C             046573
 to 27.2       cline         beef and     feed to
               approximate   nonlactati   provide
               ly 400        ng dairy     22.7 mg
               (varying      cattle: As   decoquinat
               with body     in           e and 1
               weight and    paragraph    gram (g)
               feed          (e)(2)(i)    chlortetra
               consumption   of this      cycline
               to provide    section;     per 100 lb
               10 mg/lb of   for          body
               body weight   treatment    weight
               per day)      of           (0.5 mg/
                             bacterial    kg) per
                             enteritis    day for
                             caused by    not more
                             E. coli;     than 5
                             and for      days. Type
                             treatment    C feed may
                             of           be
                             bacterial    prepared
                             pneumonia    from Type
                             caused by    B feed
                             Pasteurell   containing
                             a            535.8 to
                             multocida    5,440 g/
                             organisms    ton
                             susceptibl   decoquinat
                             e to         e and
                             chlortetra   6,700 to
                             cycline.     80,000 g/
                                          ton
                                          chlortetra
                                          cycline.
                                          When
                                          consumed,
                                          feed 22.7
                                          mg
                                          decoquinat
                                          e per 100
                                          lb body
                                          weight/day
                                          for a
                                          total of
                                          28 days to
                                          prevent
                                          coccidiosi
                                          s.
                                          Withdraw
                                          24 hours
                                          prior to
                                          slaughter
                                          when
                                          manufactur
                                          ed from
                                          CTC
                                          (chlortetr
                                          acycline)
                                          Type A
                                          medicated
                                          articles
                                          under NADA
                                          141-147.
                                          Zero
                                          withdrawal
                                          time when
                                          manufactur
                                          ed from
                                          AUREOMYCIN
                                          (chlortetr
                                          acycline)
                                          Type A
                                          medicated
                                          articles
                                          under NADA
                                          141-185.
                                          Do not
                                          feed to
                                          calves to
                                          be
                                          processed
                                          for veal.
                                          Do not
                                          feed to
                                          animals
                                          producing
                                          milk for
                                          food.

[[Page 401]]

 
(iv) 13.6 to  Monensin 5    Cattle fed   Feed only               046573
 27.2          to 30         in           to cattle
                             confinemen   fed in
                             t for        confinemen
                             slaughter:   t for
                             As in        slaughter.
                             paragraph    Feed
                             (e)(2)(i)    continuous
                             of this      ly as the
                             section;     sole
                             and for      ration to
                             improved     provide
                             feed         22.7 mg of
                             efficiency   decoquinat
                             .            e per 100
                                          lb body
                                          weight per
                                          day and 50
                                          to 360 mg
                                          of
                                          monensin
                                          per head
                                          per day.
                                          Feed at
                                          least 28
                                          days
                                          during
                                          period of
                                          exposure
                                          to
                                          coccidiosi
                                          s or when
                                          it is
                                          likely to
                                          be a
                                          hazard. Do
                                          not feed
                                          to animals
                                          producing
                                          milk for
                                          food. Also
                                          see
                                          paragraph
                                          (d)(1) of
                                          this
                                          section
                                          and Sec.
                                          558.355(d)
                                          (8).
                                          Monensin
                                          as
                                          provided
                                          by No.
                                          000986 in
                                          Sec.
                                          510.600(c)
                                          of this
                                          chapter.
(v) 13.6 to   Monensin 5    Cattle fed   Feed only               046573
 27.2          to 30 plus    in           to cattle
               tylosin 8     confinemen   fed in
               to 10         t for        confinemen
                             slaughter:   t for
                             As in        slaughter.
                             paragraph    Feed
                             (e)(2)(i)    continuous
                             of this      ly as the
                             section;     sole
                             for          ration to
                             improved     provide
                             feed         22.7 mg of
                             efficiency   decoquinat
                             ; and for    e per 100
                             reduction    lb body
                             of           weight per
                             incidence    day, 50 to
                             of liver     360 mg of
                             abscesses    monensin
                             caused by    per head
                             Fusobacter   per day,
                             ium          and 60 to
                             necrophoru   90 mg of
                             m and        tylosin
                             Actinomyce   per head
                             s            per day.
                             (Corynebac   Feed at
                             terium)      least 28
                             pyogenes.    days
                                          during
                                          period of
                                          exposure
                                          to
                                          coccidiosi
                                          s or when
                                          it is
                                          likely to
                                          be a
                                          hazard. Do
                                          not feed
                                          to animals
                                          producing
                                          milk for
                                          food. Also
                                          see
                                          paragraph
                                          (d)(1) of
                                          this
                                          section
                                          and Sec.
                                          558.355(d)
                                          (8).
                                          Monensin
                                          and
                                          tylosin as
                                          provided
                                          by No.
                                          000986 in
                                          Sec.
                                          510.600(c)
                                          of this
                                          chapter.
------------------------------------------------------------------------

    (3) Minor species.

------------------------------------------------------------------------
 Decoquinate   Combination  Indications
in grams/ton  in grams/ton    for use    Limitations        Sponsor
------------------------------------------------------------------------
(i) 12.9 to   ............  1. Young     Feed Type C             046573
 90.8                        sheep: For   feed or
                             the          milk
                             prevention   replacer
                             of           at a rate
                             coccidiosi   to provide
                             s caused     22.7 mg
                             by Eimeria   per 100 lb
                             ovinoidali   of body
                             s, E.        weight
                             crandallis   (0.5 mg
                             , E.         per kg)
                             parva, and   per day;
                             E.           feed for
                             bakuensis.   at least
                                          28 days
                                          during
                                          periods of
                                          exposure
                                          to
                                          coccidiosi
                                          s or when
                                          it is
                                          likely to
                                          be a
                                          hazard. Do
                                          not feed
                                          to sheep
                                          producing
                                          milk for
                                          food.
              ............  2. Young     Feed Type C  ..................
                             goats: For   feed or
                             the          milk
                             prevention   replacer
                             of           at a rate
                             coccidiosi   to provide
                             s caused     22.7 mg
                             by E.        per 100 lb
                             christense   of body
                             ni and E.    weight
                             ninakohlya   (0.5 mg
                             kimovae.     per kg)
                                          per day;
                                          feed for
                                          at least
                                          28 days
                                          during
                                          periods of
                                          exposure
                                          to
                                          coccidiosi
                                          s or when
                                          it is
                                          likely to
                                          be a
                                          hazard. Do
                                          not feed
                                          to goats
                                          producing
                                          milk for
                                          food.

[[Page 402]]

 
(ii) 90.9 to  ............  1. Young     Feed as a               046573
 535.7                       sheep: As    top dress
                             in item 1    at a rate
                             of           to provide
                             paragraph    22.7 mg
                             (e)(3)(i)    per 100 lb
                             of this      of body
                             section.     weight
                                          (0.5 mg
                                          per kg)
                                          per day;
                                          feed for
                                          at least
                                          28 days
                                          during
                                          periods of
                                          exposure
                                          to
                                          coccidiosi
                                          s or when
                                          it is
                                          likely to
                                          be a
                                          hazard. Do
                                          not feed
                                          to sheep
                                          producing
                                          milk for
                                          food.
              ............  2. Young     Feed as a    ..................
                             goats: As    top dress
                             in item 2    at a rate
                             of           to provide
                             paragraph    22.7 mg
                             (e)(3)(i)    per 100 lb
                             of this      of body
                             section.     weight
                                          (0.5 mg
                                          per kg)
                                          per day;
                                          feed for
                                          at least
                                          28 days
                                          during
                                          periods of
                                          exposure
                                          to
                                          coccidiosi
                                          s or when
                                          it is
                                          likely to
                                          be a
                                          hazard. Do
                                          not feed
                                          to goats
                                          producing
                                          milk for
                                          food.
------------------------------------------------------------------------


[67 FR 72370, Dec. 5, 2002; 68 FR 15372, Mar. 31, 2003]



Sec.  558.198  Diclazuril.

    (a) Specifications. Type A medicated article containing 0.2 percent 
diclazuril.
    (b) Approvals. See No. 000061 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:

----------------------------------------------------------------------------------------------------------------
       Diclazuril grams/ton         Combination grams/ton   Indications for use       Limitations       Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 0.91 (1 part per million        .....................  Broiler chickens:     Feed continuously.       000061
 (ppm)).                                                    For the prevention    Not for use in hens
                                                            of coccidiosis        producing eggs for
                                                            caused by Eimeria     human food..
                                                            tenella, E.
                                                            necatrix, E.
                                                            acervulina, E.
                                                            brunetti, E. mitis
                                                            (mivati), and E.
                                                            maxima. Because
                                                            diclazuril is
                                                            effective against
                                                            E. maxima later in
                                                            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 (1 ppm).................  Bacitracin methylene   Broiler chickens: As  As in item (i) of        000061
                                     disalicylate 4 to 50.  in item (i) of this   this table.
                                                            table; for            Bacitracin
                                                            increased rate of     methylene
                                                            weight gain and       disalicylate
                                                            improved feed         provided by 046573..
                                                            efficiency..
(iii) 0.91 (1 ppm)................  Bacitracin methylene   Broiler chickens: As  Feed continuously as     000061
                                     disalicylate 50 plus   in item (i) of this   the sole ration
                                     roxarsone 22.7 to      table; as an aid in   throughout growing
                                     45.4.                  the prevention of     period. Use as sole
                                                            necrotic enteritis    source of organic
                                                            caused or             arsenic; drug
                                                            complicated by        overdose or lack of
                                                            Clostridium spp. or   water may result in
                                                            other organisms       leg weakness. Not
                                                            susceptible to        for use in hens
                                                            bacitracin; for       producing eggs for
                                                            increased rate of     human consumption.
                                                            weight gain,          Withdraw 5 days
                                                            improved feed         before slaughter.
                                                            efficiency, and       Bacitracin
                                                            improved              methylene
                                                            pigmentation..        disalicylate and
                                                                                  roxarsone provided
                                                                                  by No. 046573 in
                                                                                  Sec.   510.600(c)
                                                                                  of this chapter..

[[Page 403]]

 
(iv) 0.91 (1 ppm).................  Bacitracin methylene   Broiler chickens: As  Feed continuously as     000061
                                     disalicylate 100 to    in item (i) of this   the sole ration
                                     200 plus roxarsone     table; as an aid in   throughout growing
                                     22.7 to 45.4.          the control of        period. Start at
                                                            necrotic enteritis    first clinical
                                                            caused or             signs of disease;
                                                            complicated by        vary dosage of
                                                            Clostridium spp. or   bacitracin based on
                                                            other organisms       severity of
                                                            susceptible to        infection;
                                                            bacitracin; for       administer
                                                            increased rate of     continuously for 5
                                                            weight gain,          to 7 days or as
                                                            improved feed         long as clinical
                                                            efficiency, and       signs persist, then
                                                            improved              reduce bacitracin
                                                            pigmentation..        to prevention level
                                                                                  (50 grams per ton
                                                                                  (g/ton). Use as
                                                                                  sole source of
                                                                                  organic arsenic;
                                                                                  drug overdose or
                                                                                  lack of water may
                                                                                  result in leg
                                                                                  weakness. Not for
                                                                                  use in hens
                                                                                  producing eggs for
                                                                                  human consumption.
                                                                                  Withdraw 5 days
                                                                                  before slaughter.
                                                                                  Bacitracin
                                                                                  methylene
                                                                                  disalicylate and
                                                                                  roxarsone provided
                                                                                  by No. 046573 in
                                                                                  Sec.   510.600(c)
                                                                                  of this chapter..
(v) 0.91 (1 ppm)..................  Bambermycins 1 to 2..  Broiler chickens: As  As in item (i) of        000061
                                                            in item (i) of this   this table.
                                                            table); for           Bambermycins
                                                            increased rate of     provided by 057926..
                                                            weight gain and
                                                            improved feed
                                                            efficiency..
(vi) 0.91 (1 ppm).................  Virginiamycin 5......  Broiler chickens: As  As in item (i) of        000061
                                                            in item (i) of this   this table;
                                                            table; for            Virginiamycin
                                                            increased rate of     provided by 066104..
                                                            weight gain and
                                                            improved feed
                                                            efficiency..
(vii) 0.91 (1 ppm)................  Virginiamycin 5 to 15  Broiler chickens: As  As in item (i) of        000061
                                                            in item (i) of this   this table.
                                                            table; for            Virginiamycin
                                                            increased rate of     provided by 066104..
                                                            weight gain..
----------------------------------------------------------------------------------------------------------------

    (2) Turkeys. For turkeys it is used as follows:

----------------------------------------------------------------------------------------------------------------
       Diclazuril grams/ton         Combination grams/ton   Indications for use       Limitations       Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 0.91 (1 ppm)..................  .....................  Growing turkeys: For  Feed continuously as     000061
                                                            the prevention of     the sole ration. Do
                                                            coccidiosis caused    not feed to
                                                            by E. adenoeides,     breeding turkeys.
                                                            E. gallopavonis and   Not for use in hens
                                                            E. meleagrimitis..    producing eggs for
                                                                                  human consumption..
(ii) 0.91 (1 ppm).................  Bacitracin methylene   Growing turkeys: As   As in paragraph          000061
                                     disalicylate 4 to      in paragraph          (d)(2)(i) of this
                                     50..                   (d)(2)(i) of this     section. Bacitracin
                                                            section; for          methylene
                                                            increased rate of     disalicylate
                                                            weight gain and       provided by No.
                                                            improved feed         046573 in Sec.
                                                            efficiency..          510.600(c) of this
                                                                                  chapter..
(iii) 0.91 (1 ppm)................  Bambermycins 1 to 2..  Growing turkeys: As   As in paragraph          000061
                                                            in paragraph          (d)(2)(i) of this
                                                            (d)(2)(i) of this     section.
                                                            section; for          Bambermycins
                                                            improved feed         provided by No.
                                                            efficiency..          057926 in Sec.
                                                                                  510.600(c) of this
                                                                                  chapter..
(iv) 0.91 (1 ppm).................  Bambermycins 2.......  Growing turkeys: As   As in paragraph          000061
                                                            in paragraph          (d)(2)(i) of this
                                                            (d)(2)(i) of this     section.
                                                            section; for          Bambermycins
                                                            increased rate of     provided by No.
                                                            weight gain and       057926 in Sec.
                                                            improved feed         510.600(c) of this
                                                            efficiency..          chapter..
----------------------------------------------------------------------------------------------------------------


[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]



Sec.  558.205  Dichlorvos.

    (a) Approvals. Type A medicated articles: 3.1 and 9.6 percent to 
000010 in Sec.  510.600(c) of this chapter.
    (b) Special considerations. (1) Dichlorvos is to be included in meal 
or

[[Page 404]]

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 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.
    (c) Related tolerances. See Sec.  556.180 of this chapter.
    (d) Conditions of use. It is used in feed for swine as follows:
    (1) Amount per ton. Dichlorvos, 348 grams (0.0384 percent).
    (i) Indications for use. For the removal and control of mature, 
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.
    (ii) Limitations. For swine up to 70 pounds body weight, feed as 
sole ration for 2 consecutive days. For swine from 70 pounds to market 
weight, feed as sole ration at the rate of 8.4 pounds of feed per head 
until the medicated feed has been consumed. For boars, open or bred 
gilts, and sows, feed as sole ration at the rate of 4.2 pounds per head 
per day for 2 consecutive days.
    (2) Amount per ton. Dichlorvos, 479 grams (0.0528 percent).
    (i) Indications for use. For the removal and control of mature, 
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.
    (ii) Limitations. For boars, open or bred gilts, and sows, feed as 
sole ration at the rate of 6 pounds per head for one feeding.
    (3) Amount per ton. Dichlorvos, 334-500 grams (0.0366-0.0550 
percent).
    (i) Indications for use. An aid in improving litter production 
efficiency by increasing pigs born alive, birth weights, survival to 
market, and rate of weight gain. Treatment also removes and controls 
mature, immature and/or fourth stage larvae of whipworm (Trichuris 
suis), nodular worm (Oesophagostomum supp.) large roundworm (Ascaris 
suum), and the thick stomach worm (Ascarops strongylina) occurring in 
the gastrointestinal tract of the sow or gilt.
    (ii) Limitations. For pregnant swine; mix into a gestation feed to 
provide 1,000 milligrams per head daily during last 30 days of 
gestation.

[40 FR 13959, Mar. 27, 1975, as amended at 40 FR 50258, Oct. 29, 1975; 
48 FR 46515, Oct. 13, 1983; 51 FR 7397, Mar. 3, 1986; 51 FR 28547, Aug. 
8, 1986; 52 FR 2684, Jan. 26, 1987; 62 FR 35077, June 30, 1997]



Sec.  558.235  Efrotomycin.

    (a) Approvals. Type A medicated article: 14.5 grams per pound to 
050604 in Sec.  510.600(c) of this chapter.
    (b) Conditions of use--(1) Swine. (i) Amount. 3.6 grams per ton.
    (A) Indications for use. For improved feed efficiency.
    (B) Limitations. Feed continuously as sole ration. Not to be used in 
swine weighing more than 250 pounds.
    (ii) Amount. 3.6 to 14.5 grams per ton.
    (A) Indications for use. For increased rate of weight gain.
    (B) Limitations. Feed continuously as sole ration. Not to be used in 
swine weighing more than 250 pounds.
    (2) [Reserved]

[57 FR 38442, Aug. 25, 1992, as amended at 62 FR 63271, Nov. 28, 1997]



Sec.  558.248  Erythromycin thiocyanate.

    (a) Approvals. Type A medicated articles: (1) 2.2 percent to 061623 
in

[[Page 405]]

Sec.  510.600(c) of this chapter for use as in paragraph (d) of this 
section.
    (2) 5 and 10 percent to 061623 for use in paragraphs (d)(1)(i) and 
(ii) of this section.
    (b) Special considerations. The levels of antibiotic are expressed 
in terms of erythromycin master standard. One gram of erythromycin 
thiocyanate is equivalent to 0.925 gram of erythromycin master standard.
    (c) Related tolerances. See Sec.  556.230 of this chapter.
    (d) Condition of use. (1) It is used as follows:

----------------------------------------------------------------------------------------------------------------
 Erythromycin thiocyanate in    Combination in grams
        grams per ton                 per ton            Indications for use         Limitations        Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 4.6 to 18.5.............  .......................  Chickens; growth        ......................          ,
                                                        promotion and feed                                061623
                                                        efficiency.
(ii) 9.25 to 18.5...........  .......................  Turkeys; growth         For turkeys not over            ,
                                                        promotion and feed      12 weeks of age.          061623
                                                        efficiency.
(iii) 9.25 to 64.75.........  .......................  Swine; increase in      Starter ration for         061623
                                                        weight gain, improved   animals up to 35 lb
                                                        feed efficiency in      body weight.
                                                        starter pigs (9.25 to
                                                        64.75) and grower-
                                                        finishing pigs (9.25).
(iv) 18.5...................  .......................  Laying chickens; aids   ......................     061623
                                                        in increasing egg
                                                        production.
(v) 92.5....................  .......................  1. Chickens; as an aid  Feed for 2 d before        061623
                                                        in the prevention of    stress and 3 to 6 d
                                                        chronic respiratory     after stress;
                                                        disease during          withdraw 24 h before
                                                        periods of stress.      slaughter.
                                                       2. Chickens; as an aid  Feed for 7 to 14 d;     .........
                                                        in the prevention of    withdraw 24 h before
                                                        infectious coryza.      slaughter.
                                                       3. Turkeys; as an aid   Feed for 2 d before     .........
                                                        in the prevention of    stress and 3 to 6 d
                                                        chronic respiratory     after stress.
                                                        disease during
                                                        periods of stress.
(vi) 185....................  .......................  1. Chickens; as an aid  Feed for 5 to 8 d; do      061623
                                                        in the prevention and   not use in birds
                                                        reduction of lesions    producing eggs for
                                                        and in lowering         food purposes;
                                                        severity of chronic     withdraw 48 h before
                                                        respiratory disease.    slaughter.
                                                       2. Turkeys; as an aid   Feed for 5 to 8 d; do      061623
                                                        in the prevention and   not use in birds
                                                        reduction of lesions    producing eggs for
                                                        and in lowering         food purposes.
                                                        severity of chronic
                                                        respiratory disease.
----------------------------------------------------------------------------------------------------------------

    (2) In feed for feedlot beef cattle at 37 milligrams per head per 
day as an aid in stimulating growth and improving feed efficiency.
    (3) Erythromycin thiocyanate may be used in accordance with the 
provisions of this section in the combinations provided as follows:
    (i) Amprolium in accordance with Sec.  558.55.
    (ii) Amprolium and ethopabate in accordance with Sec.  558.58.
    (iii) Arsanilic acid in accordance with Sec.  558.62.
    (iv) Zoalene in accordance with Sec.  558.680.

[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]



Sec.  558.254  Famphur.

    (a) Approvals. Type A medicated articles: 13.2 and 33.3 percent to 
000061 in Sec.  510.600(c) of this chapter.
    (b) 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.
    (c) Related tolerances. See Sec.  556.273 of this chapter.
    (d) Conditions of use. It is used in the feed for cattle as follows:
    (1) Amount. 1.1 milligrams per pound body weight per day.
    (i) Indications for use. For control of grubs and as an aid in 
control of sucking lice.
    (ii) Limitations. For beef cattle and nonlactating dairy cows; feed 
for 30

[[Page 406]]

days; withdraw from dry dairy cows and heifers 21 days prior to 
freshening; withdraw 4 days prior to slaughter.
    (2) Amount. 2.3 milligrams per pound body weight per day.
    (i) Indications for use. For control of grubs.
    (ii) Limitations. For beef cattle and nonlactating dairy cows; feed 
for 10 days; withdraw from dry dairy cows and heifers 21 days prior to 
freshening; withdraw 4 days prior to slaughter.

[41 FR 11000, Mar. 15, 1976, as amended at 51 FR 7397, Mar. 3, 1986; 57 
FR 7652, Mar. 4, 1992; 62 FR 55161, Oct. 23, 1997; 62 FR 61626, Nov. 19, 
1997]



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) Approvals. See No. 057926 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.

----------------------------------------------------------------------------------------------------------------
 Amount fenbendazole in grams     Combination in    Indications for
            per ton               grams per ton           use            Limitations             Sponsor
----------------------------------------------------------------------------------------------------------------
14.5 (16 parts per million)...  .................  Growing turkeys:   Feed                               057926
                                                    For the removal    continuously as
                                                    and control of     the sole ration
                                                    gastrointestinal   for 6 days. For
                                                    worms: round       growing turkeys
                                                    worms, adult and   only.
                                                    larvae
                                                    (Ascaridia
                                                    dissimilis);
                                                    cecal worms,
                                                    adult and larvae
                                                    (Heterakis
                                                    gallinarum), an
                                                    important vector
                                                    of Histomonas
                                                    meleagridis
                                                    (Blackhead).
----------------------------------------------------------------------------------------------------------------

    (2) Swine.

----------------------------------------------------------------------------------------------------------------
Amount fenbendazole in grams per    Combination in      Indications for
               ton                   grams per ton            use             Limitations           Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 10 to 300 (to provide 9       ..................  For the removal     Feed as sole        057926
 milligrams per kilogram (mg/kg)                       and control of:     ration.
 of body weight) given over a 3-                       Adult stage
 to 12-day period.                                     lungworms
                                                       (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 80 (to provide 9 mg/   Lincomycin 20.....  As in paragraph     Feed as sole        057926
 kg of body weight).                                   (e)(2)(i) of this   ration. Do not
                                                       section; for        feed to swine
                                                       increased rate of   that weigh more
                                                       gain in growing-    than 250 pounds
                                                       finishing swine.    (lbs); lincomycin
                                                                           as provided by
                                                                           000009 in Sec.
                                                                           510.600(c) of
                                                                           this chapter.
(iii) 10 to 80 (to provide 9 mg/  Lincomycin 40.....  As in paragraph     Feed as sole        057926
 kg of body weight).                                   (e)(2)(i) of this   ration. Do not
                                                       section; for        feed to swine
                                                       control of swine    that weigh more
                                                       dysentery in        than 250 lbs.;
                                                       animals on          lincomycin as
                                                       premises with a     provided by
                                                       history of swine    000009 in Sec.
                                                       dysentery, but      510.600(c) of
                                                       where symptoms      this chapter.
                                                       have not yet
                                                       occurred.
(iv) 10 to 80 (to provide 9 mg/   Lincomycin 100....  As in paragraph     Feed as sole        057926
 kg of body weight).                                   (e)(2)(i) of this   ration. Do not
                                                       section; for the    use within 6 days
                                                       treatment of        of slaughter. Do
                                                       swine dysentery.    not feed to swine
                                                                           that weigh more
                                                                           than 250 lbs.;
                                                                           lincomycin as
                                                                           provided by
                                                                           000009 in Sec.
                                                                           510.600(c) of
                                                                           this chapter.

[[Page 407]]

 
(v) 10 to 80 (to provide 9 mg/kg  Lincomycin 200....  As in paragraph     Feed as sole        057926
 of body weight).                                      (e)(2)(i) of this   ration. Do not
                                                       section; for        use within 6 days
                                                       reduction in the    of slaughter. Do
                                                       severity of swine   not feed to swine
                                                       mycoplasmal         that weigh more
                                                       pneumonia caused    than 250 pound
                                                       by Mycoplasma       (lb); lincomycin
                                                       hyopneumoniae.      as provided by
                                                                           000009 in Sec.
                                                                           510.600(c) of
                                                                           this chapter.
(vi) 10 to 300 (to provide 9 mg/  Bacitracin          Growing/finishing   Feed as sole        046573
 kg of body weight).               methylene           swine: As in        ration. Under
                                   disalicylate 10     paragraph           conditions of
                                   to 30.              (e)(2)(i) of this   continued
                                                       section; for        exposure to
                                                       increased rate of   parasites,
                                                       weight gain and     retreatment may
                                                       improved feed       be needed after 4
                                                       efficiency.         to 6 weeks.
                                                                           Bacitracin
                                                                           methylene
                                                                           disalicylate as
                                                                           provided by
                                                                           046573 in Sec.
                                                                           510.600(c) of
                                                                           this chapter.
(vii) 10 to 300 (to provide 9 mg/ Bacitracin          1. Growing/         1. Growing/         046573
 kg of body weight).               methylene           finishing swine:    finishing swine:
                                   disalicylate 250.   As in paragraph     Feed as sole
                                                       (e)(2)(i) of this   ration. Not for
                                                       section; for        use in growing
                                                       control of swine    and finishing
                                                       dysentery           swine that weigh
                                                       associated with     more than 250
                                                       Treponema           lbs. Diagnosis of
                                                       hyodysenteriae on   swine dysentery
                                                       premises with a     should be
                                                       history of swine    confirmed by a
                                                       dysentery, but      veterinarian when
                                                       where signs of      results are not
                                                       disease have not    satisfactory.
                                                       yet occurred; or    Under conditions
                                                       following an        of continued
                                                       approved            exposure to
                                                       treatment of the    parasites,
                                                       disease condition.  retreatment may
                                                                           be needed after 4
                                                                           to 6 weeks.
                                                                           Bacitracin
                                                                           methylene
                                                                           disalicylate as
                                                                           provided by
                                                                           046573 in Sec.
                                                                           510.600(c) of
                                                                           this chapter.
                                  ..................  2. Pregnant sows:   2. Pregnant sows:   ..................
                                                       As in paragraph     Feed as sole
                                                       (e)(2)(i) of this   ration. Diagnosis
                                                       section; for        of clostridial
                                                       control of          enteritis should
                                                       clostridial         be confirmed by a
                                                       enteritis in        veterinarian when
                                                       suckling pigs       results are not
                                                       caused by           satisfactory.
                                                       Clostridium         Under conditions
                                                       perfringens.        of continued
                                                                           exposure to
                                                                           parasites,
                                                                           retreatment may
                                                                           be needed after 4
                                                                           to 6 weeks.
                                                                           Bacitracin
                                                                           methylene
                                                                           disalicylate as
                                                                           provided by
                                                                           046573 in Sec.
                                                                           510.600(c) of
                                                                           this chapter.
----------------------------------------------------------------------------------------------------------------

    (3) Cattle--(i) Conditions of use are as follows:

[[Page 408]]



----------------------------------------------------------------------------------------------------------------
 Amount fenbendazole in grams per  Combination in grams
               ton                        per ton         Indications for use      Limitations         Sponsor
----------------------------------------------------------------------------------------------------------------
(A) 5 mg/kg body weight (2.27 mg/  ....................  For the removal and   Feed as sole ration       057926
 lb).                                                     control of            for one day. Do
                                                          lungworms             not use within 13
                                                          (Dictyocaulus         days of slaughter.
                                                          viviparus);
                                                          barberpole worms
                                                          (Haemonchus
                                                          contortus); brown
                                                          stomach worms
                                                          (Ostertagia
                                                          ostertagi); small
                                                          stomach worms
                                                          (Trichostrongylus
                                                          axei); hookworms
                                                          (Bunostomum
                                                          phlebotomum);
                                                          thread-necked
                                                          intestinal worms
                                                          (Nematodirus
                                                          helvetianus); small
                                                          intestinal worms
                                                          (Cooperia oncophora
                                                          and C. punctata),
                                                          bankrupt worms
                                                          (Trichostrongylus
                                                          colubriformis), and
                                                          nodular worms
                                                          (Oesophagostomum
                                                          radiatum).
(B) 5 mg/kg body weight (2.27 mg/  ....................  As in paragraph       Formulate as              057926
 lb) in a free-choice feed.                               (e)(3)(i)(A) of       specified in
                                                          this section.         paragraph
                                                                                (e)(3)(ii) of this
                                                                                section. 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. Do not
                                                                                slaughter within
                                                                                13 days following
                                                                                last treatment.
----------------------------------------------------------------------------------------------------------------

    (ii) Formulate for use as a free-choice cattle feed as in paragraph 
(e)(3)(i)(B) of this section as follows:

------------------------------------------------------------------------
                                               International
          Ingredient\1\             Percent       feed No.
------------------------------------------------------------
(A) Ingredient:.................  ...........  .............
 Copper sulfate.................         0.45      6-01-720
 Dried Cane Molasses............         3.12      4-04-695
 Monosodium phosphate...........        31.16      6-04-288
 Salt (sodium chloride).........        59.00      6-04-152
 Zinc sulfate...................         0.76      6-05-556
 Fenbendazole Type A article             5.51  .............
 (20%)..........................
(B) Ingredient:.................  ...........  .............
 Dicalcium phosphate............        32.31      6-00-080
 Limestone......................        17.13      6-02-632
 Magnesium oxide................         9.79      6-02-756
 Zinc sulfate...................         1.47      6-05-556
 Copper sulfate.................         0.29      6-01-720
 Potassium iodide...............       0.0098      6-03-759
 Dried Cane Molasses............         0.98      4-04-695
 Selenium.......................       0.0002  .............
 Salt...........................        35.93      6-04-152
 Fenbendazole Type A article             2.09  .............
 (20%)..........................
------------------------------------------------------------------------
\1\The content of any added vitamin and trace mineral 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. The amount of selenium must comply with published
  regulations.

    (4) Zoo and wildlife animals.

----------------------------------------------------------------------------------------------------------------
                                      Amount        Indications for
         Species/Class             fenbendazole           use            Limitations             Sponsor
----------------------------------------------------------------------------------------------------------------
(i) Feral swine (Sus scrofa)..  3 mg/kg/day for 3  For the removal    Use as complete                    057926
                                 days..             and control of     feed. Prior
                                                    kidney worm        withdrawal of
                                                    (Stephanurus       feed or water
                                                    dentatus),         is not
                                                    roundworm          necessary.
                                                    (Ascaris suum),    Retreatment may
                                                    nodular worm       be required in
                                                    (Oesophagostomum   6 weeks. Do not
                                                    dentatum).         use 14 days
                                                                       before or
                                                                       during the
                                                                       hunting season.

[[Page 409]]

 
(ii) Ruminants (subfamily       2.5 mg/kg/day for  For the removal    Use as complete                    057926
 Antilopinae, Hippotraginae,     3 days..           and control of     feed. Prior
 Caprinae).                                         small stomach      withdrawal of
                                                    worm               feed or water
                                                    (Trichostrongylu   is not
                                                    s spp.), thread    necessary.
                                                    necked             Retreatment may
                                                    intestinal worm    be required in
                                                    (Nematodirus       6 weeks. Do not
                                                    spp.),             use 14 days
                                                    barberpole worm    before or
                                                    (Haemonchus        during the
                                                    spp.), whipworm    hunting season.
                                                    (Trichuris spp.).
(iii) Rocky mountain bighorn    10 mg/kg/day for   For the removal    Use as complete                    057926
 sheep (Ovis c. canadensis).     3 days..           and control of     feed. Prior
                                                    Protostrongylus    withdrawal of
                                                    spp.               feed or water
                                                                       is not
                                                                       necessary.
                                                                       Retreatment may
                                                                       be required in
                                                                       6 weeks. Do not
                                                                       use 14 days
                                                                       before or
                                                                       during the
                                                                       hunting season.
----------------------------------------------------------------------------------------------------------------


[66 FR 58935, Nov. 26, 2001]



Sec.  558.265  Halofuginone hydrobromide.

    (a) Approvals. Type A medicated articles: 6 grams per kilogram (2.72 
grams per pound) to 057926 in Sec.  510.600(c) of this chapter.
    (b) Related tolerances. See Sec.  556.308 of this chapter.
    (c) Conditions of use. (1) It is used in feed for broiler chickens 
as follows:
    (i) Amount. 2.72 grams per ton.
    (A) Indications for use. For the prevention of coccidiosis caused by 
Eimeria tenella, E. necatrix, E. acervulina, E. brunetti, E. mivati, and 
E. maxima.
    (B) Limitations. Feed continuously as sole ration; withdraw 4 days 
before slaughter; do not feed to layers; avoid contact with skin, eyes, 
or clothing; keep out of lakes, ponds, or streams.
    (ii) Amount per ton. Halofuginone 2.72 grams (0.0003 percent) plus 
bambermycins 1 to 2 grams.
    (A) Indications for use. For the prevention of coccidiosis caused by 
Eimeria tenella, E. necatrix, E. acervulina, E. brunetti, E. mivati, and 
E. maxima; for increased rate of weight gain and improved feed 
efficiency.
    (B) Limitations. Feed continuously as sole ration; withdraw 5 days 
before slaughter; do not feed to layers.
    (iii) Amount per ton. Halofuginone 2.72 grams (0.0003 percent) plus 
virginiamycin 5 grams.
    (A) Indications for use. For the prevention of coccidiosis caused by 
Eimeria tenella, E. necatrix, E. acervulina, E. brunetti, E. mivati, and 
E. maxima; for increased rate of weight gain and improved feed 
efficiency.
    (B) Limitations. Feed continuously as sole ration; withdraw 6 days 
before slaughter; do not feed to layers.
    (iv) Amount per ton. Halofuginone 2.72 grams (0.0003 percent) plus 
virginiamycin 5 to 15 grams.
    (A) Indications for use. For the prevention of coccidiosis caused by 
Eimeria tenella, E. necatrix, E. acervulina, E. brunetti, E. mevati, and 
E. maxima; for increased rate of weight gain.
    (B) Limitations. Feed continuously as sole ration; withdraw 6 days 
before slaughter; do not feed to layers.
    (v) Amount per ton. Halofuginone hydrobromide 2.72 grams (0.0003 
percent) plus bacitracin methylene disalicylate 10 to 50 grams and 
roxarsone 22.7 to 45.4 grams.
    (A) Indications for use. For the prevention of coccidiosis caused by 
Eimeria tenella, E. necatrix, E. acervulina, E. brunetti, E. mivati, and 
E. maxima; for increased rate of weight gain; and for improved feed 
efficiency.
    (B) Limitations. Feed continuously as sole ration; withdraw 5 days 
before slaughter; use as sole source of organic arsenic; do not feed to 
layers; avoid contact with skin, eyes, or clothing; keep out of lakes, 
ponds, or streams.
    (vi) Amount per ton. Halofuginone 2.72 grams (0.0003 percent) plus 
bacitracin methylene disalicylate 10 to 50 grams.
    (A) Indications for use. For the prevention of coccidiosis caused by 
Eimeria tenella, E. necatrix, E. acervulina, E. brunetti, E. mevati, E. 
maxima and for improved feed efficiency.
    (B) Limitations. Feed continuously as sole ration; withdraw 5 days 
before slaughter; do not feed to layers; avoid

[[Page 410]]

contact with skin, eyes, or clothing; keep out of lakes, ponds, or 
streams.
    (vii) Amount per ton. Halofuginone 2.72 grams (0.0003 percent) plus 
lincomycin 2 to 4 grams.
    (A) Indications for use. For the prevention of coccidiosis caused by 
Eimeria tenella, E. necatrix, E. acervulina, E. brunetti, E. mivati, and 
E. maxima and for improved feed efficiency.
    (B) Limitations. Feed continuously as sole ration; withdraw 4 days 
before slaughter; do not feed to layers; avoid contact with skin, eyes, 
or clothing; keep out of lakes, ponds, or streams.
    (viii) Amount per ton. Halofuginone hydrobromide, 2.72 grams plus 
roxarsone, 22.7 to 45.4 grams.
    (A) Indications for use. For the prevention of coccidiosis caused by 
Eimeria tenella, E. necatrix, E. acervulina, E. brunetti, E. mivati, and 
E. maxima; for increased rate of weight gain, improved feed efficiency, 
and improved pigmentation.
    (B) Limitations. Feed continuously as sole ration to replacement 
cage laying chickens until 20 weeks of age. Feed continuously as sole 
ration to replacement broiler breeder chickens until 16 weeks of age. 
Use as the sole source of organic arsenic; drug overdose or lack of 
water intake may result in leg weakness or paralysis. Do not feed to 
laying chickens or waterfowl. Withdraw 5 days before slaughter.
    (2) It is used in feed for turkeys as follows:
    (i) Amount per ton. 1.36 to 2.72 grams.
    (A) Indications for use. For the prevention of coccidiosis in 
growing turkeys caused by Eimeria adenoeides, E. meleagrimitis, and E. 
gallopavonis.
    (B) Limitations. Feed continuously as sole ration; withdraw 7 days 
before slaughter; do not feed to layers or water fowl; avoid contact 
with skin, eyes, or clothing; keep out of lakes, ponds, or streams.
    (ii) Amount per ton. Halofuginone hydrobromide 1.36 to 2.72 grams 
plus bacitracin methylene disalicylate 10 to 50 grams.
    (A) Indications for use. For prevention of coccidiosis caused by 
Eimeria adenoeides, E. meleagrimitis., and E. gallopavonis, and for 
increased rate of weight gain in growing turkeys.
    (B) Limitations. Feed continuously as sole ration. Withdraw 7 days 
before slaughter. Do not feed to laying chickens or water fowl. Keep out 
of lakes, ponds, and streams. Halofuginone is toxic to fish and aquatic 
life. Halofuginone is an irritant to eyes and skin. Avoid contact with 
skin, eyes, or clothing.
    (iii) Amount per ton. 1.36 to 2.72 grams of halofuginone 
hydrobromide plus 2 grams of bambermycins.
    (A) Indications for use. For the prevention of coccidiosis caused by 
Eimeria adenoides, E. meleagrimitis, and E. gallopavonis, and for 
increased rate of weight gain in growing turkeys.
    (B) Limitations. Feed continuously as sole ration. Withdraw 7 days 
before slaughter. Do not feed to laying chickens or waterfowl. 
Halofuginone hydrobromide is toxic to fish and other aquatic life. Keep 
out of lakes, ponds, and streams. Halofuginone hydrobromide is an eye 
and skin irritant. Avoid contact with skin, eyes, and clothing.
    (3) It is used in feed for replacement cage laying chickens and 
replacement broiler breeder chickens as follows:
    (i) Amount per ton. 2.72 grams.
    (A) Indications for use. For the prevention of coccidiosis caused by 
Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. mivati/E. 
mitis, and E. brunetti.
    (B) Limitations. Feed continuously as sole ration to replacement 
cage laying chickens until 20 weeks of age. Feed continuously as sole 
ration to replacement broiler breeder chickens until 16 weeks of age. 
Withdraw 4 days before slaughter. Do not feed to laying chickens or 
water fowl. Halofuginone hydrobromide is toxic to fish and aquatic life. 
Keep out of lakes, ponds, and streams. Halofuginone hydrobromide is an 
irritant to eyes and skin. Avoid contact with skin, eyes, and clothing.
    (ii) Amount per ton. Halofuginone hydrobromide, 2.72 grams plus 
roxarsone, 22.7 to 45.4 grams.
    (A) Indications for use. For the prevention of coccidiosis caused by 
Eimeria tenella, E. necatrix, E. acervulina, E. brunetti, E. mivati, and 
E. maxima; for increased rate of weight gain, improved

[[Page 411]]

feed efficiency, and improved pigmentation.
    (B) Limitations. Feed continuously as sole ration to replacement 
cage laying chickens until 20 weeks of age. Feed continuously as sole 
ration to replacement broiler breeder chickens until 16 weeks of age. 
Use as the sole source of organic arsenic; drug overdose or lack of 
water intake may result in leg weakness or paralysis. Do not feed to 
laying chickens or waterfowl. Withdraw 5 days before slaughter.

[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]



Sec.  558.274  Hygromycin B.

    (a) Approvals. (1) Type A medicated articles: 2.4 and 8 grams per 
pound to 000986 in Sec.  510.600(c) of this chapter for use as in 
paragraph (c) of this section.
    (2) 2.4 grams per pound to 043733 in Sec.  510.600(c) of this 
chapter for use in swine feed as in paragraph (c)(1)(ii) of this 
section.
    (3) [Reserved]
    (4) 0.6 gram per pound to 017790, 043733, and 050639 in Sec.  
510.600(c) of this chapter for use in chickens as in paragraph (c)(1)(i) 
of this section and in swine as in paragraph (c)(1)(ii) of this section.
    (5)-(6) [Reserved]
    (7) 2.4 grams per pound to 017519 in Sec.  510.600(c) of this 
chapter for use in chickens as in paragraph (c)(1)(i) and in swine as in 
paragraph (c)(1)(ii) of this section.
    (8) 0.6 and 1.6 grams per pound granted to 046573 in Sec.  
510.600(c) of this chapter for use in chickens as in paragraph (c)(1)(i) 
and in swine as in paragraph (c)(1)(ii) of this section.
    (b) Related tolerances. See Sec.  556.330 of this chapter.
    (c) Conditions of use. (1) It may be used as follows:

----------------------------------------------------------------------------------------------------------------
  Hygromycin B in grams per     Combination in grams
             ton                      per ton            Indications for use         Limitations        Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 8 to 12.................  .......................  Chickens: control of    Withdraw 3 days before    000986,
                                                        infestation of large    slaughter.               017519,
                                                        roundworms (Ascaris                              017790,
                                                        galli), cecal worms                              043733,
                                                        (Heterakis gallinae),                            046573,
                                                        and capillary worms                               050639
                                                        (Capillaria
                                                        obsignata).
                              Bacitracin 100.........  Chickens; control of    As bacitracin           .........
                                                        infestation of large    methylene
                                                        roundworms (Ascaris     disalicylate or zinc
                                                        galli), cecal worms     bacitracin; withdraw
                                                        (Heterakis gallinae),   3 days before
                                                        and capillary worms     slaughter.
                                                        (Capillaria
                                                        obsignata); treatment
                                                        of chronic
                                                        respiratory disease
                                                        (airsac infection),
                                                        blue comb
                                                        (nonspecific
                                                        infectious enteritis).
                              Bacitracin plus          1. Chickens; control    Feed containing not     .........
                               penicillin (100 to 200   of infestation of       less than 25% of
                               of combination).         large roundworms        penicillin plus not
                                                        (Ascaris galli),        less than 50% of
                                                        cecal worms             bacitracin; as
                                                        (Heterakis gallinae),   procaine penicillin
                                                        and capillary worms     plus bacitracin
                                                        (Capillaria             methylene
                                                        obsignata); treatment   disalicylate;
                                                        of chronic              withdraw 3 days
                                                        respiratory disease     before slaughter.
                                                        (airsac infection),
                                                        blue comb
                                                        (nonspecific
                                                        infectious enteritis).
                                                       2. Chickens; control    Combination containing  .........
                                                        of infestation of       not less than 50% nor
                                                        large roundworms        more than 75% of
                                                        (Ascaris galli),        bacitracin, except
                                                        cecal worms             that it contains not
                                                        (Heterakis gallinae),   more than 125 g of
                                                        and capillary worms     penicillin; as
                                                        (Capillaria             procaine penicillin
                                                        obsignata); treatment   plus zinc bacitracin;
                                                        of chronic              withdraw 3 days
                                                        respiratory disease     before slaughter.
                                                        (airsac infection),
                                                        blue comb
                                                        (nonspecific
                                                        infectious enteritis).

[[Page 412]]

 
                                                       3. Chickens, control    Combination containing  .........
                                                        of infestation of       50% to 75%
                                                        large roundworms        bacitracin, but not
                                                        (Ascaris galli),        more than 125 g of
                                                        cecal worms             penicillin, as
                                                        (Heterakis gallinae),   procaine penicillin;
                                                        and capillary worms     withdraw 3 days
                                                        (Capillaria             before slaughter..
                                                        obsignata); treatment
                                                        of chronic
                                                        respiratory disease
                                                        (airsac infection),
                                                        blue comb
                                                        (nonspecific
                                                        infectious enteritis).
                              Chlortetracycline 100    Chickens; control of    Do not feed to          .........
                               to 200.                  infestation of large    chickens producing
                                                        roundworms (Ascaris     eggs for human
                                                        galli), cecal worms     consumption; feed for
                                                        (Heterakis gallinae),   7 to 14 days;
                                                        and capillary worms     withdraw 3 days
                                                        (Capillaria             before slaughter.
                                                        obsignata); control
                                                        of infectious
                                                        synovitis caused by
                                                        Mycoplasma synoviae
                                                        susceptible to
                                                        chlortetracycline.
                              Chlortetracycline 200    Chickens; control of    ......do..............  .........
                               to 400.                  infestation of large
                                                        roundworms (Ascaris
                                                        galli), cecal worms
                                                        (H. Gallinae), and
                                                        capillary worms
                                                        (Capillaria
                                                        obsignata); control
                                                        of chronic
                                                        respiratory disease
                                                        (CRD) and air sac
                                                        infection caused by
                                                        Mycoplasma
                                                        gallisepticum and
                                                        Escherichia coli
                                                        susceptible to
                                                        chlortetracycline.
                              Penicillin 100.........  Chickens; control of    As procaine             .........
                                                        infestation of large    penicillin; withdraw
                                                        roundworms (Ascaris     3 days before
                                                        galli), cecal worms     slaughter.
                                                        (Heterakis gallinae),
                                                        and capillary worms
                                                        (Capillaria
                                                        obsignata); treatment
                                                        of chronic
                                                        respiratory disease
                                                        (airsac infection),
                                                        blue comb
                                                        (nonspecific
                                                        infectious enteritis).
                              Tylosin 4 to 50........  Chickens: Control of    As tylosin phosphate;      000986
                                                        infestations of large   withdraw 3 days
                                                        roundworms (Ascaris     before slaughter.
                                                        galli), cecal worms
                                                        (Heterakis
                                                        gallinae,), and
                                                        capillary worms
                                                        (Capillaria
                                                        obsignata); growth
                                                        promotion and feed
                                                        efficiency.
(ii) 12.....................  .......................  Swine: control of       Withdraw 15 days          000986,
                                                        infestation of large    before slaughter.        017519,
                                                        roundworms (Ascaris                              017790,
                                                        suis), nodular worms                             043733,
                                                        (Oesophagostomum                                 046573,
                                                        dentatum), and                                    050639
                                                        whipworms (Trichuris
                                                        suis).
                              Chlortetracycline 400..  Swine; control of       Withdraw 15 d before    .........
                                                        infestation of large    slaughter..
                                                        roundworms (Ascaris
                                                        suis), nodular worms
                                                        (Oesophagostomum
                                                        dentatum) and
                                                        whipworms (Trichuris
                                                        suis); treatment of
                                                        bacterial enteritis
                                                        caused by E. coli and
                                                        Salmonella
                                                        choleraesuis and
                                                        bacterial pneumonia
                                                        caused by P.
                                                        multocida susceptible
                                                        to chlortetracycline..
                              Tylosin 10 to 100......  Swine: Control of       As tylosin phosphate;      000986
                                                        infestations of large   withdraw 15 days
                                                        roundworms (Ascaris     prior to slaughter;
                                                        suis), nodular worms    feed continuously as
                                                        (Oesophagostomum        follows:.
                                                        dentatum), and         Animal wt.(lbs.):.....
                                                        whipworms (Trichuris    Up to 40........20 to
                                                        suis); growth           100\1\.
                                                        promotion and feed      41 to 100........20
                                                        efficiency.             to 40\1\.
                                                                                101 to market
                                                                                wt........10 to 20\1\.
----------------------------------------------------------------------------------------------------------------
\1\ Amount of Tylosin (g/t).


[[Page 413]]

    (2) Hygromycin B may also be used in combination with:
    (i) Amprolium in accordance with Sec.  558.55.
    (ii) Zoalene in accordance with Sec.  558.680.

[41 FR 11000, Mar. 15, 1976]

    Editorial Note: For Federal Register citations affecting Sec.  
558.274, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and on GPO Access.



Sec.  558.295  Iodinated casein.

    (a) Approvals. See 017762 in Sec.  510.600(c) of this chapter.
    (b) NAS/NRC status. The use of this drug is NAS/NRC reviewed and 
found effective. Applications for these uses need not include efficacy 
data as required by Sec.  514.111 of this chapter but may require 
bioequivalency or safety data.
    (c) Conditions of use--(1) Ducks--(i) Amount per ton. 100 to 200 
grams.
    (ii) Indications for use. For increased rate of weight gain and 
improved feathering in growing ducks.
    (2) Dairy cows--(i) Amount per pound. \1/2\ to 1\1/2\ grams per 100 
lb of body weight.
    (ii) Indications for use. For increased milk production in dairy 
cows.
    (iii) Limitations. This drug is effective for 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.

[45 FR 41631, June 20, 1980]



Sec.  558.300  Ivermectin.

    (a) Approvals. (1) Type A medicated articles: 0.6 percent (2.72 
grams per pound; 6 grams per kilogram) to 050604 in Sec.  510.600(c) of 
this chapter, and
    (2) Type B medicated feeds for ivermectin alone or with lincomycin. 
See Sec.  558.4 of this chapter for maximum drug levels to 050604 in 
Sec.  510.600(c) of this chapter.
    (b) Related tolerances. See Sec.  556.344 of this chapter.
    (c) [Reserved]
    (d) Conditions of use. It is used in swine feed as follows:
    (1) Amount per ton. For weaned, growing-finishing swine, feed 1.8 
grams of ivermectin (to provide 0.1 milligram per kilogram of body 
weight per day). For adult and breeding swine, feed 1.8 to 11.8 grams of 
ivermectin (to provide 0.1 milligram per kilogram of body weight per 
day). For adult and breeding swine, may be top-dressed on daily ration 
for individual treatment at levels of 18.2 to 1180 grams (to provide 0.1 
milligram per kilogram of body weight per day).
    (i) Indications for use. For treatment and control of 
gastrointestinal roundworms (Ascaris suum, adults and fourth-stage 
larvae; Ascarops strongylina, 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).
    (ii) Limitations. For use in swine feed only. Feed as only feed for 
7 consecutive days. Withdraw 5 days before slaughter. Consult your 
veterinarian for assistance in the diagnosis, treatment, and control of 
parasitism.
    (2) Amount per ton. 1.8 grams of ivermectin (to provide 0.1 
milligram per kilogram of body weight per day) with 20 grams of 
lincomycin.
    (i) Indications for use. For treatment and control of 
gastrointestinal roundworms (Ascaris suum, adults and fourth-stage 
larvae; Ascarops strongylina, 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), lice (Haematopinus 
suis), and mange mites (Sarcoptes scabiei var. suis). For increased rate 
of weight gain.
    (ii) Limitations. For weaned, growing-finishing swine. Feed as only 
feed for 7

[[Page 414]]

consecutive days. Withdraw 5 days before slaughter. A separate feed 
containing 20 grams per ton lincomycin may be continued. Not to be fed 
to swine that weigh more than 250 pounds. 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. Consult your veterinarian for assistance in 
the diagnosis, treatment, and control of parasitism.
    (3) Amount per ton. 1.8 grams of ivermectin (to provide 0.1 
milligram per kilogram of body weight per day) with 40 grams of 
lincomycin.
    (i) Indications for use. For treatment and control of 
gastrointestinal roundworms (Ascaris suum, adults and fourth-stage 
larvae; Ascarops strongylina, 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), lice (Haematopinus 
suis), and mange mites (Sarcoptes scabiei var. suis). For control of 
swine dysentery. For use in swine on premises with a history of swine 
dysentery, but where symptoms have not yet occurred.
    (ii) Limitations. For weaned, growing-finishing swine. Feed as only 
feed for 7 consecutive days. Withdraw 5 days before slaughter. A 
separate feed containing 40 grams per ton lincomycin may be continued. 
Not to be fed to swine that weigh more than 250 pounds. 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. Consult your veterinarian for assistance in 
the diagnosis, treatment and control of parasitism.
    (4) Amount per ton. 1.8 grams of ivermectin (to provide 0.1 
milligram per kilogram of body weight per day) with 100 grams of 
lincomycin.
    (i) Indications for use. For treatment and control of 
gastrointestinal roundworms (Ascaris suum, adults and fourth-stage 
larvae; Ascarops strongylina, 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), lice (Haematopinus 
suis), and mange mites (Sarcoptes scabiei var. suis). Treatment of swine 
dysentery.
    (ii) Limitations. For weaned, growing-finishing swine. Feed as only 
feed for 7 consecutive days followed by a separate feed containing 100 
grams per ton lincomycin for an additional 14 days to complete the 
lincomycin treatment. Withdraw 6 days before slaughter. Not to be fed to 
swine that weigh more than 250 pounds. 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. Consult your veterinarian for assistance in the diagnosis, 
treatment, and control of parasitism.
    (5) Amount per ton. 1.8 grams of ivermectin (to provide 0.1 
milligram per kilogram of body weight per day) with 200 grams of 
lincomycin.
    (i) Indications for use. For treatment and control of 
gastrointestinal roundworms (Ascaris suum, adults and fourth-stage 
larvae; Ascarops strongylina, 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), lice (Haematopinus 
suis), and mange mites (Sarcoptes scabiei var. suis). For reduction in 
severity of swine mycoplasmal pneumonia caused by Mycoplasma 
hyopneumoniae.
    (ii) Limitations. For weaned, growing-finishing swine. Feed as only 
feed for 7 consecutive days followed by a separate feed containing 200 
grams per ton lincomycin for an additional 14 days to complete the 
lincomycin treatment. Withdraw 6 days before slaughter. Not to be fed to 
swine that weigh more than 250 pounds. 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. Consult your veterinarian for

[[Page 415]]

assistance in the diagnosis, treatment, and control of parasitism.
    (6) Amount per ton. For weaned, growing-finishing pigs, feed 1.8 
grams of ivermectin (to provide 0.1 milligram per kilogram of body 
weight per day), and 10 to 30 or 250 grams of bacitracin methylene 
disalicylate. For adult and breeding swine, feed 1.8 grams of ivermectin 
(to provide 0.1 milligram per kilogram of body weight per day), and 10 
to 30 or 250 grams of bacitracin methylene disalicylate.
    (i) Indications for use. For treatment and control of 
gastrointestinal roundworms (Ascaris suum, adults and fourth-stage 
larvae; Ascarops strongylina, 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). For increased rate of weight gain and 
improved feed efficiency in growing and finishing swine. For control of 
clostridial enteritis caused by Clostridium perfringens in suckling 
piglets. For control of swine dysentery associated with Treponema 
hypdysenteriae on premises with a history of swine dysentery but where 
signs of disease have not yet occurred, or following an approved 
treatment of disease condition.
    (ii) Limitations. For use in swine feed only. Feed as the only feed 
for 7 consecutive days. For weaned growing and finishing swine, feed 
bacitracin methylene disalicylate Type C medicated feed from weaning to 
market weight for increased rate of weight gain and improved feed 
efficiency. For pregnant sows, feed bacitracin methylene disalicylate to 
sows from 14 days before through 21 days after farrowing on premises 
with a history of clostridial scours. Withdraw ivermectin-containing 
feeds 5 days before slaughter.

[58 FR 58653, Nov. 3, 1993, as amended at 60 FR 39848, Aug. 4, 1995; 61 
FR 32652, June 25, 1996; 62 FR 63271, Nov. 28, 1997; 63 FR 54353, Oct. 
9, 1998; 64 FR 13342, Mar. 18, 1999]



Sec.  558.305  Laidlomycin.

    (a) Specifications. Type A medicated articles containing 50 grams 
laidlomycin propionate potassium per pound.
    (b) Approvals. See No. 046573 in Sec.  510.600(c) of this chapter.
    (c) 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 Type B 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 Type B 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.

[[Page 416]]

    (d) Conditions of use. It is used in cat- tle being fed in 
confinement for slaugh- ter as follows:

------------------------------------------------------------------------
 Laidlomycin   Combination
in grams per  in grams per    Indications   Limitations      Sponsor
     ton           ton          for use
------------------------------------------------------------------------
(1) 5         ............  For improved    Feed                 046573
                             feed            continuous
                             efficiency      ly in a
                             and increased   Type C
                             rate of         feed at a
                             weight gain.    rate of 30
                                             to 75 mg/
                                             head/day.
(2) 5         Chlortetracy  For improved    Feed                 046573
               cline10 mg/   feed            continuous
               lb body       efficiency      ly at a
               weight        and increased   rate of 30
                             rate of         to 75 mg
                             weight gain;    laidlomyci
                             and for         n
                             treatment of    propionate
                             bacterial       potassium
                             enteritis       per head
                             caused by       per day
                             Echerichia      for not
                             coli and        more than
                             bacterial       5 days. A
                             pneumonia       withdrawal
                             caused by       period has
                             Pasteurella     not been
                             multocida       establishe
                             organisms       d for this
                             susceptible     product in
                             to              pre-
                             chlortetracyc   ruminating
                             line.           calves. Do
                                             not use in
                                             calves to
                                             be
                                             processed
                                             for veal.
(3) 5         Chlortetracy  For improved    Feed                 046573
               cline 350     feed            continuous
               mg/head/day   efficiency      ly at a
                             and increased   rate of 30
                             rate of         to 75 mg
                             weight gain;    laidlomyci
                             and for         n
                             control of      propionate
                             bacterial       potassium
                             pneumonia       per head
                             associated      per day. A
                             with shipping   withdrawal
                             fever complex   period has
                             caused by       not been
                             Pasteurella     establishe
                             spp.            d for this
                             susceptible     product in
                             to              pre-
                             chlortetracyc   ruminating
                             line.           calves. Do
                                             not use in
                                             calves to
                                             be
                                             processed
                                             for veal.
(4) 5 to 10   ............  For improved    Feed                 046573
                             feed            continuous
                             efficiency.     ly in a
                                             Type C
                                             feed at a
                                             rate of 30
                                             to 150
                                             milligrams/
                                             head/day.
(5) 5 to 10   Chlortetracy  For improved    Feed                 046573
               cline 10 mg/  feed            continuous
               pound body    efficiency;     ly at a
               weight        and for         rate of 30
                             treatment of    to 150 mg
                             bacterial       laidlomyci
                             enteritis       n
                             caused by E.    propionate
                             coli and        potassium
                             bacterial       per head
                             pneumonia       per day
                             caused by P.    for not
                             multocida       more than
                             organisms       5 days. A
                             susceptible     withdrawal
                             to              period has
                             chlortetracyc   not been
                             line.           establishe
                                             d for this
                                             product in
                                             pre-
                                             ruminating
                                             calves. Do
                                             not use in
                                             calves to
                                             be
                                             processed
                                             for veal.
(6) 5 to 10   Chlortetracy  For improved    Feed                 046573
               cline 350     feed            continuous
               mg/head/day   efficiency;     ly at a
                             and for         rate of 30
                             control of      to 150 mg
                             bacterial       laidlomyci
                             pneumonia       n
                             associated      propionate
                             with shipping   potassium
                             fever complex   per head
                             caused by       per day. A
                             Pasteurella     withdrawal
                             spp.            period has
                             susceptible     not been
                             to              establishe
                             chlortetracyc   d for this
                             line.           product in
                                             pre-
                                             ruminating
                                             calves. Do
                                             not use in
                                             calves to
                                             be
                                             processed
                                             for veal.
------------------------------------------------------------------------

[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]



Sec. 558.311  Lasalocid.

    (a) Specifications. A minimum of 90 percent of lasalocid activity is 
derived from lasalocid A.
    (b) Approvals. Type A medicated articles approved for sponsors 
identified in Sec.  510.600(c) of this chapter for use as in paragraph 
(e) of this section as follows:
    (1) 3.0, 3.3, 3.8, 4.0, 4.3, 4.4, 5.0, 5.1, 5.5, 5.7, 6.0, 6.3, 6.7, 
7.2, 7.5, 8.0, 8.3, 10.0, 12.5, 15, 20, and 50 percent activity to No.

[[Page 417]]

046573 for use as in paragraphs (e)(1) (i), (ii), (iii), (iv), and (x) 
of this section.
    (2) 15 percent activity to No. 066104 as provided by No. 046573 for 
use as in paragraph (e)(1)(v) of this section.
    (3) 15, 20, 33.1, and 50 percent activity to No. 046573 for use in 
cattle feeds as in paragraphs (e)(1)(vi), (vii), (ix), (xi), (xii), and 
(xv) of this section, and for use in sheep as in paragraph (e)(1)(viii) 
of this section.
    (4) 15 percent activity to No. 046573 for use in Type C rabbit feeds 
as in paragraph (e)(1)(xvi) of this section and for use in ruminant 
free-choice Type C feeds as in paragraphs (e)(2) and (e)(3) of this 
section.
    (5) 15 percent activity to 021930 (Type A article provided by 
046573) for use in free-choice vitamin-mineral Type C cattle feeds as in 
paragraph (e)(1)(xi).
    (6) 20 percent activity as a liquid Type A article to No. 046573 for 
use in cattle feeds as in paragraphs (e)(1)(vi), (e)(1)(vii), 
(e)(1)(ix), (e)(1)(xi), (e)(1)(xii), and (e)(3) of this section, and for 
use in sheep feeds as in paragraph (e)(1)(viii) of this section.
    (7) 20 percent activity to No. 046573 for use as follows:
    (i) Chukar partridges as in paragraph (e)(1)(xiii).
    (ii) Turkeys as in paragraph (e)(1)(xiv).
    (iii) Rabbits as in paragraph (e)(1)(xvi).
    (8) 15 percent activity to No. 017800 for use as in paragraph 
(e)(1)(xviii) of this section.
    (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 Type B 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 Type B 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 positionally stable lasalocid liquid Type B 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. Form FDA 1900 must 
indicate the pH and centipoises per second for such lasalocid liquid 
Type B feed.
    (3) If a manufacturer is unable to meet the requirements of 
paragraph (d)(1) or (2) of this section, the manufacturer may secure 
approval of a positionally stable liquid Type B 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 positional 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 Type B feed specified in the appropriate master file. If the 
data demonstrate the stability of the liquid Type B feed described in 
the master file, the supplement new animal drug application will be 
approved. Approval of the supplement will not be published in the 
Federal Register because such approval will not affect or alter 
conditions or use of the product in the new animal drug application or 
the regulation. The approval will, however, provide a basis for the 
individual liquid feed manufacturer to submit, and for the agency to 
approve, a medicated feed application under section 512(m) of the act 
for liquid Type B feed. A manufacturer who seeks to market a 
positionally unstable lasalocid liquid Type B 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

[[Page 418]]

Type B feed containing lasalocid is stable outside the pH of 4.0 to 8.0, 
the pH restriction described in paragraphs (d)(1) and (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.
    (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 paragraph 
(e)(1)(xii) and (e)(1)(xviii) of this section must be the subject of an 
approved NADA or supplemental NADA as provided in Sec.  510.455 of this 
chapter.
    (e)(1) Conditions of use. It is used as follows:

----------------------------------------------------------------------------------------------------------------
Lasalocid sodium activity in    Combination in grams
        grams per ton                 per ton            Indications for use         Limitations        Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 68 (0.0075 pct) to 113    .......................  For the prevention of   For broiler or fryer       046573
 (0.0125 pct).                                          coccidiosis caused by   chickens only; feed
                                                        Eimeria tenella, E.     continuously as the
                                                        necatrix, E.            sole ration.
                                                        acervulina, E.
                                                        brunetti, E. mivati,
                                                        and E. maxima.
(ii) 68 (0.0075 pct) to 113   Roxarsone 45.4 (0.005    Broiler or fryer        For broiler or fryer       046573
 (0.0125 pct).                 pct).                    chickens; for the       chickens only; feed
                                                        prevention of           continuously as the
                                                        coccidiosis caused by   sole ration; as sole
                                                        Eimeria tenella, E.     source of organic
                                                        necatrix, E.            arsenic; withdraw 5 d
                                                        acervulina, E.          before slaughter;
                                                        brunetti, E. mivati,    roxarsone provided by
                                                        and E. maxima and as    Nos. 046573 and
                                                        an aid in the           011526 in Sec.
                                                        reduction of lesions    510.600(c) of this
                                                        due to E. tenella.      chapter.
                              Roxarsone 45.4 plus      For prevention of       For broiler chickens       046573
                               bambermycins 1           coccidiosis caused by   only; feed
                               (0.00011 pct).           Eimeria tenella, E.     continuously as sole
                                                        necatrix, E.            ration; withdraw 5
                                                        acervulina, E.          days before
                                                        brunetti, E. mivati,    slaughter; roxarsone
                                                        and E. maxima; as an    provided by Nos.
                                                        aid in the reduction    046573 and 011526 in
                                                        of lesions due to E.    Sec.   510.600(c) of
                                                        tenella; and for        this chapter,
                                                        increased rate of       bambermycins provided
                                                        weight gain.            by No. 012799.
                              Roxarsone 45.4 plus      For prevention of       For broiler chickens       046573
                               lincomycin 2.0.          coccidiosis caused by   only; feed
                                                        Eimeria tenella, E.     continuously as sole
                                                        necatrix, E.            ration; withdraw 5
                                                        acervulina, E.          days before
                                                        brunetti, E. mivati,    slaughter; roxarsone
                                                        and E. maxima; as an    provided by Nos.
                                                        aid in the reduction    046573 and 011526 in
                                                        of lesions due to E.    Sec.   510.600(c) of
                                                        tenella; and for        this chapter,
                                                        increased rate of       lincomycin provided
                                                        weight gain and         by No. 000009.
                                                        improved feed
                                                        efficiency.
                              Roxarsone 45.4 plus      For prevention of       For broiler or fryer       046573
                               bacitracin 10 to 25.     coccidiosis caused by   chickens only; feed
                                                        Eimeria tenella, E.     continuously as the
                                                        necatrix, E.            sole ration; withdraw
                                                        acervulina, E.          5 days before
                                                        brunetti, E. mivati,    slaughter; roxarsone
                                                        and E. maxima; as an    provided by Nos.
                                                        aid in the reduction    046573 and 011526 in
                                                        of lesions due to E.    Sec.   510.600(c) of
                                                        tenella; and for        this chapter,
                                                        increased rate of       bacitracin methylene
                                                        weight gain.            disalicylate provided
                                                                                by No. 046573 in Sec.
                                                                                  510.600(c) of this
                                                                                chapter.

[[Page 419]]

 
                              Roxarsone 45.4 plus      For prevention of       For broiler chickens       046573
                               bacitracin 10 or 30.     coccidiosis caused by   only; feed
                                                        E. tenella, E.          continuously as sole
                                                        necatrix, E.            ration; withdraw 5
                                                        acervulina, E.          days before
                                                        brunetti, E. mivati     slaughter; roxarsone
                                                        and E. maxima; as an    provided by Nos.
                                                        aid in the reduction    046573 and 011526 in
                                                        of lesions due to E.    Sec.   510.600(c) of
                                                        tenella; and for        this chapter,
                                                        increased rate of       bacitracin zinc
                                                        weight gain (10 grams   provided by No.
                                                        per ton) or improved    000004.
                                                        feed efficiency (30
                                                        grams per ton).
                              Roxarsone 45.5 plus      Prevention of           Feed continuously as       046573
                               bacitracin methylene     coccidiosis caused by   sole ration; as sole
                               disalicylate 50.         Eimeria necatrix, E.    source of organic
                                                        tenella, E.             arsenic; withdraw 5
                                                        acervulina, E.          days before slaughter.
                                                        brunetti; E. mivati,
                                                        and E. maxima;
                                                        reduction of lesions
                                                        due to E. tenella;
                                                        prevention of
                                                        necrotic enteritis
                                                        caused or complicated
                                                        by Clostridium spp.
                                                        or other susceptible
                                                        organisms.
(iii) 68 (0.0075 pct).......  Lincomycin 2 (0.00022    Broiler or fryer        For broiler and fryer      046573
                               pct).                    chickens; for the       chickens only; feed
                                                        prevention of           continuously as sole
                                                        coccidiosis caused by   ration; withdraw 5 d
                                                        Eimeria mivati, E.      before slaughter;
                                                        brunetti, E. tenella,   Type C feed must be
                                                        E. acervulina, E.       used within 4 weeks
                                                        maxima, and E.          of manufacture; as
                                                        necatrix; for           lincomycin
                                                        increased rate of       hydrochloride
                                                        weight gain and         monohydrate.
                                                        improved feed
                                                        efficiency.
(iv) 68 (0.0075 percent)....  Bacitracin 10 to 50....  For prevention of       For broiler or fryer       046573
                                                        coccidiosis caused by   chickens only; feed
                                                        Eimeria tenella, E.     continuously as the
                                                        necatrix, E.            sole ration;
                                                        acervulina, E.          bacitracin methylene
                                                        brunetti, E. mivati,    disalicylate provided
                                                        and E. maxima, and      by No. 046573 in Sec.
                                                        for increased rate of     510.600(c) of this
                                                        weight gain and         chapter.
                                                        improved feed
                                                        efficiency.
(v) 68 (0.0075 pct) to 113    Virginiamycin 20.......  For prevention of       For broiler and fryer      046573
 (0.0125 pct).                                          coccidiosis caused by   chickens only; feed
                                                        Eimeria tenella E.      continuously as sole
                                                        necatrix, E.            ration; do not feed
                                                        acervulina, E.          to laying chickens;
                                                        brunetti, E. mivati,    lasalocid sodium
                                                        and E. maxima, and      provided by No.
                                                        for increased rate of   046573 in Sec.
                                                        weight gain and         510.600(c) of this
                                                        improved feed           chapter.
                                                        efficiency.
(vi) 10 (0.0011 pct) to 30    .......................  Cattle; for improved    In Type C feeds; for       046573
 (0.0033 pct).                                          feed efficiency.        cattle fed in
                                                                                confinement for
                                                                                slaughter only; feed
                                                                                continuously in
                                                                                complete feed to
                                                                                provide not less than
                                                                                100 mg nor more than
                                                                                360 mg of lasalocid
                                                                                sodium activity per
                                                                                head per day.
                              Oxytetracycline 7.5....  Cattle: for improved    In Type C feeds, for       046573
                                                        feed efficiency and     beef cattle fed in
                                                        reduction of            confinement for
                                                        incidence and           slaughter; feed
                                                        severity of liver       continuously at 100
                                                        abscesses.              to 360 mg/head/day
                                                                                lasalocid and 75 mg/
                                                                                head/day
                                                                                oxytetracycline. As
                                                                                monoalkyl (C8-C18)
                                                                                trimethyl ammonium
                                                                                oxytetracycline.
(vii) 25 (0.0027 pct) to 30   .......................  Cattle; for improved    In Type C feeds; for       046573
 (0.0033 pct).                                          feed efficiency and     cattle fed in
                                                        increased rate of       confinement for
                                                        weight gain.            slaughter only; feed
                                                                                continuously in
                                                                                complete feed to
                                                                                provide not less than
                                                                                250 mg nor more than
                                                                                360 mg of lasalocid
                                                                                sodium activity per
                                                                                head per day.
                              Oxytetracycline 7.5....  Cattle: for improved    In Type C feeds, for       046573
                                                        feed efficiency,        beef cattle fed in
                                                        increased rate of       confinement for
                                                        weight gain, and        slaughter; feed
                                                        reduction of            continuously at 250
                                                        incidence and           to 360 mg/head/day
                                                        severity of liver       lasalocid and 75 mg/
                                                        abscesses.              head/day
                                                                                oxytetracycline. As
                                                                                monoalkyl (C8-C18)
                                                                                trimethyl ammonium
                                                                                oxytetracycline.

[[Page 420]]

 
(viii) 20 (0.0022 pct) to 30  .......................  Sheep; for the          In Type C feeds; for       046573
 (0.0033 pct).                                          prevention of           sheep maintained in
                                                        coccidiosis caused by   confinement; feed
                                                        Eimeria ovina, E.       continuously in
                                                        crandallis, E.          complete feed to
                                                        ovinoidalis (E.         provide not less than
                                                        ninakohlyakimovae),     15 mg nor more than
                                                        E. parva, and E.        70 mg of lasalocid
                                                        intricata.              sodium activity per
                                                                                head per day
                                                                                depending on body
                                                                                weight.
(ix)........................  .......................  Pasture cattle          Feed continuously at a     046573
                                                        (slaughter, stocker,    rate of not less than
                                                        feeder cattle, and      60 mg or more than
                                                        dairy and beef          300 mg of lasalocid
                                                        replacement heifers):   per head per day when
                                                        for increased rate of   on pasture; the drug
                                                        weight gain. Intakes    must be contained in
                                                        of lasalocid in         at least 1 pound of
                                                        excess of 200 mg/head/  feed..
                                                        day have not been
                                                        shown to be more
                                                        effective than 200 mg/
                                                        head/day..
(x) 68 (0.0075 pct) to 113    Bacitracin 4 to 50.....  Broiler chickens; for   For broiler chickens       046573
 (0.0125 pct).                                          prevention of           only; feed
                                                        coccidiosis caused by   continuously as the
                                                        Eimeria tenella, E.     sole ration;
                                                        necatrix, E.            bacitracin methylene
                                                        acervulina, E.          disalicylate provided
                                                        brunetti, E. mivati,    by No. 046573 in Sec.
                                                        and E. maxima; and        510.600(c) of this
                                                        for improved feed       chapter.
                                                        efficiency.
(xi) 68 (0.0075 pct) to 113   Bacitracin zinc 4 to     Broiler chickens. For   Feed continuously as       046573
 (0.0125 pct)..                50..                     prevention of           sole ration.
                                                        coccidiosis caused by   Bacitracin zinc and
                                                        Eimeria tenella, E.     lasalocid sodium as
                                                        necatrix, E.            provided by No.
                                                        acervulina, E.          046573 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..
(xii).......................  .......................  Pasture cattle          Feed continuously on a     046573
                                                        (slaughter, stocker,    free-choice basis at
                                                        feeder cattle, and      a rate of not less
                                                        dairy and beef          than 60 mg or more
                                                        replacement heifers):   than 300 mg of
                                                        For increased rate of   lasalocid per head
                                                        weight gain. Intakes    per day..
                                                        of lasalocid in
                                                        excess of 200 mg/head/
                                                        day have not been
                                                        shown to be more
                                                        effective than 200 mg/
                                                        head/day..
(xiii)......................  .......................  Cattle; for control of   For cattle; hand feed     046573
                                                        coccidiosis caused by   at a rate of 1 mg of
                                                        Eimeria bovis and       lasalocid per 2.2
                                                        Eimeria zuernii.        pounds body weight
                                                                                per day to cattle
                                                                                weighing up to 800
                                                                                pounds with a maximum
                                                                                of 360 mg of
                                                                                lasalocid per head
                                                                                per day.
(xiv) 113 (0.0125 pct)......  .......................  Chukar partridges; for  Feed continuously as       046573
                                                        prevention of           sole ration up to 8
                                                        coccidiosis caused by   weeks of age.
                                                        Eimeria legionensis.
(xv) 68 (0.0075 pct) to 113   .......................  Growing turkeys; for    Feed continuously as       046573
 (0.0125 pct).                                          prevention of           sole ration.
                                                        coccidiosis caused by
                                                        E. meleagrimitis, E.
                                                        gallopavonis, and E.
                                                        adenoeides..
                              Bacitracin 4 to 50.....  Growing turkeys; for    Feed continuously as       046573
                                                        prevention of           sole ration.
                                                        coccidiosis caused by
                                                        E. meleagrimitis, E.
                                                        gallopavonis, and E.
                                                        adenoeides; for
                                                        increased rate of
                                                        weight gain and
                                                        improved feed
                                                        efficiency..
                              Bacitracin methylene     Growing turkeys; for    Feed continuously as       046573
                               [chyph]disalicylate 4    [chyph]prevention of    sole ration.
                               to 50.                   coccidiosis caused by   Bacitracin methylene
                                                        E. meleagrimitis, E.    disalicylate as
                                                        gallopavonis, and E.    provided by No.
                                                        adenoeides; for         046573 in Sec.
                                                        increased rate of       510.600(c) of this
                                                        weight gain and         chapter..
                                                        improved feed
                                                        efficiency..
                              Virginiamycin 10 to 20.  Growing turkeys; for    Feed continuously as       046573
                                                        prevention of           sole ration. As
                                                        coccidiosis caused by   lasalocid sodium
                                                        E. meleagrimitis, E.    provided by 063238
                                                        gallopavonis, and E.    and virginiamycin
                                                        adenoeides, and for     provided by 066104..
                                                        increased rate of
                                                        weight gain and
                                                        improved feed
                                                        efficiency..

[[Page 421]]

 
(xvi).......................  .......................  Replacement calves;     In milk replacer           046573
                                                        for control of          powder; hand feed at
                                                        coccidiosis caused by   a rate of 1 mg of
                                                        E. bovis and E.         lasalocid per 2.2 lb
                                                        zuernii..               body weight per day;
                                                                                include on labeling
                                                                                warning: ``A
                                                                                withdrawal period has
                                                                                not been established
                                                                                for lasalocid in pre-
                                                                                ruminating calves. Do
                                                                                not use in calves to
                                                                                be processed for
                                                                                veal''.
(xvii) 113 (0.0125 pct).....  .......................  Rabbits; for            Feed continuously as       046573
                                                        prevention of           sole ration up to 6 1/
                                                        coccidiosis caused by   2 weeks of age.
                                                        Eimeria stiedae.
(xviii) 1440................  .......................  Pasture cattle          Feed continuously on a     021930
                                                        (slaughter, stocker,    free-choice basis at      017800
                                                        feeder cattle, and      a rate of not less
                                                        dairy and beef          than 60 mg nor more
                                                        replacement heifers):   than 200 mg of
                                                        For increased rate of   lasalocid per head
                                                        weight gain..           per day..
----------------------------------------------------------------------------------------------------------------

    (2) It is used as a free-choice mineral Type C feed as follows:
    (i) Specifications.

------------------------------------------------------------------------
                                                           International
                   Ingredient                     Percent     feed No.
------------------------------------------------------------------------
Defluorinated Phosphate (20.5 percent Calcium,     35.9       6-01-080
 18.5 percent Phosphorus).......................
Sodium Chloride (Salt)..........................   20.0       6-04-152
Calcium Carbonate (38 percent Calcium)..........   18.0       6-01-069
Cottonseed Meal.................................   10.0       5-01-621
Potassium Chloride..............................    3.0       6-03-755
Selenium Premix (0.02 percent Selenium) \1\.....    3.0    .............
Dried Cane Molasses.............................    2.5       4-04-695
Magnesium Sulfate...............................    1.7       6-02-758
Vitamin Premix \1\..............................    1.4    .............
Magnesium Oxide.................................    1.2       6-02-756
Potassium Sulfate...............................    1.2       6-06-098
Trace Mineral Premix \1\........................    1.04   .............
Bovatec Premix (68 grams per pound).............    1.06   .............
------------------------------------------------------------------------
\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. The amount of selenium and ethylenediamine
  dihydroiodide (EDDI) must comply with published regulations. For
  selenium (21 CFR 573.920): 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.

    (ii) Amount. 1,440 grams per ton (0.16 percent).
    (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; each use of this Type C free-choice feed must be the subject of 
an approved FD-1900 as provided in Sec.  510.455 of this chapter.
    (v) Sponsor. See No. 046573 in Sec.  510.600(c) of this chapter.
    (3) 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    N/A
 Solubles.
50% Urea Solution (23% N)........      12.0    N/A
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    N/A
Trace Mineral Mix 1..............       0.5    N/A
Vitamin Premix 1.................       0.2    N/A
Bovatec Liquid 20 (90.8 gm/lb) 2.       0.083  N/A
------------------------------------------------------------------------
\1\ Content of vitamin and trace mineral premixes may be varied.
  However, they should be comparable to those used for other free-choice
  liquid feeds. Formulation modifications require FDA approval prior to
  marketing. The amount of selenium and ethylenediamine dihydroiodide
  (EDDI) must comply with published regulations (for selenium see 21 CFR
  573.920; for EDDI see 51 FR 11483, April 3, 1986).
\2\ To provide 150 gm lasalocid per ton, use 1.652 lb (0.083%) of
  Bovatec Liquid 20 (90.8 gm/lb). If dry Bovatec-68 (68 gm/lb) is used,
  use 2.206 lbs per ton (0.111%), replacing molasses.


[[Page 422]]

    (ii) Amount. 150 grams per ton (.017 percent).
    (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. Each use of this free-choice liquid Type C feed must be the 
subject of an approved FD-1900 as in Sec.  510.455 of this chapter.
    (v) Sponsor. See No. 046573 in Sec.  510.600(c) of this chapter.
    (4) Additional combinations. Lasalocid may be used in accordance 
with the provisions of this section in combination as follows:
    (i) Melengestrol acetate alone or in combination with tylosin in 
accordance with Sec.  558.342.
    (ii) Bambermycins as in Sec.  558.95 of this chapter.

[41 FR 44382, Oct. 8, 1976]

    Editorial Note: 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 on GPO Access.



Sec.  558.315  Levamisole hydrochloride (equivalent).

    (a) Approvals. Type A medicated articles: 227 grams per pound to No. 
053501 in Sec.  510.600(c) of this chapter.
    (b) Related tolerances. See Sec.  556.350 of this chapter.
    (c) Conditions of use. It is used in Type C medicated feed as 
follows:
    (1) Cattle--(i) Amount per pound. 0.36-3.6 grams (0.08-0.8 percent).
    (ii) Indications for use. Treatment of the following 
gastrointestinal worms and lung worm infections; stomach worms 
(Haemonchus, Trichostrongylus, Ostertagia), intestinal worms 
(Trichostrongylus Cooperia, Nematodirus, Bunostomum, Oesophagostomum), 
and lungworms (Dictyocaulus).
    (iii) Limitations. Administer medicated feed mixed thoroughly in one 
half the usual amount of morning feed; the medicated feed mix should be 
consumed within 6 hours; when medicated feed is consumed resume normal 
feeding; medicated feed is to be fed at the rate of 0.36 gram of 
levamisole hydrochloride (equivalent) per 100 lb. of body weight; 
conditions of constant helminth exposure may require retreatment within 
2 to 4 weeks after the first treatment; do not slaughter for food within 
48 hours of treatment; consult veterinarian before using in severely 
debilitated animals; do not administer to dairy animals of breeding age; 
for use in pelleted or meal feeds only; the label shall bear the 
caution, ``Muzzle foam may be observed. However, this reaction will 
disappear within a few hours. If this condition persists, a veterinarian 
should be consulted. Follow recommended dosage carefully.''
    (2) Swine--(i) Amount per pound. 0.36 grams (0.08 percent).
    (ii) Indications for use. Treatment of the following nematode 
infections: large roundworms (Ascaris suum), nodular worms 
(Oesophagostomum spp.), lungworms (Metastrongylus spp.), intestinal 
threadworms (Strongyloides ransomi), swine kidney worms (Stephanurus 
dentatus).
    (iii) Limitations. It is recommended that regular feed be withheld 
overnight and worming feed administered the following morning; dilute 
supplement with nonmedicated feed as directed; feed the equivalent of 1 
lb. of 0.08 percent worming feed per 100 lbs. of body weight of pigs to 
be treated; may be fed as sole feed or thoroughly mixed with 1 to 2 
parts of regular feed prior to feeding; when medicated feed is consumed, 
resume normal feeding. Pigs maintained under conditions of constant worm 
exposure may require retreatment within 4 to 5 weeks after the first 
treatment due to reinfection; do not slaughter for food within 72 hours 
of treatment; the label shall bear the caution, ``Excessive salivation 
or muzzle foam may be observed. This reaction is occasionally seen and 
will disappear in a short time after medication. If pigs are infected 
with mature lungworms, coughing and vomiting may be observed soon after 
medicated feed is consumed. This reaction is due to the

[[Page 423]]

expulsion of worms from the lungs and will be over in several hours.''

[40 FR 13959, Mar. 27, 1975, as amended at 43 FR 11176, Mar. 17, 1978; 
43 FR 39351, Sept. 5, 1978; 43 FR 16013, Mar. 16, 1979; 51 FR 7398, Mar. 
3, 1986; 67 FR 63055, Oct. 10, 2002]



Sec.  558.325  Lincomycin.

    (a) Approvals. Type A articles and Type B feeds approved for 
sponsors in Sec.  510.600(c) of this chapter for specific uses as in 
paragraph (d) of this section as follows:
    (1) No. 000009 for 20 and 50 grams per pound.
    (2)-(4) [Reserved]
    (5) No. 043733 for 8 and 20 grams per pound.
    (6)-(12) [Reserved]
    (13) No. 017800 for 2.5 and 8 grams per pound.
    (14)-(15) [Reserved]
    (b) Related tolerances. See Sec.  556.360 of this chapter.
    (c) [Reserved]
    (d) Conditions of use--(1) Chickens. It is used in feed as follows:

------------------------------------------------------------------------
   Lincomycin      Indications for
   grams/ton             use              Limitations          Sponsor
------------------------------------------------------------------------
(i) 2            Broilers: For       As lincomycin               000009
                  control of          hydrochloride
                  necrotic            monohydrate.
                  enteritis caused
                  by Clostridium
                  spp. or other
                  susceptible
                  organisms.
------------------------------------------------------------------------
(ii) 2 to 4      Broilers: For       As lincomycin               000009
                  increased rate of   hydrochloride
                  weight gain and     monohydrate.
                  improved feed
                  efficiency.
------------------------------------------------------------------------

    (2) Swine. It is used in feed as follows:

------------------------------------------------------------------------
   Lincomycin      Indications for
   grams/ton             use              Limitations          Sponsor
------------------------------------------------------------------------
(i) 20           Growing-finishing   Feed as sole ration.        000009
                  swine: For          Not to be fed to
                  increased rate of   swine that weigh
                  weight gain.        more than 250 pounds
                                      (lb).
------------------------------------------------------------------------
(ii) 40          1. For control of   Feed as sole ration;        000009
                  swine dysentery.    for use in swine on        017800
                                      premises with a            043733
                                      history of swine
                                      dysentery but where
                                      symptoms have not
                                      yet occurred, or
                                      following use of
                                      lincomycin at 100
                                      grams (g)/ton for
                                      treatment of swine
                                      dysentery. Not to be
                                      fed to swine that
                                      weigh more than 250
                                      lb.
                 2. For control of   Feed as sole ration,        000009
                  porcine             or following use of
                  proliferative       lincomycin at 100 g/
                  enteropathies       ton for control of
                  (ileitis) caused    porcine
                  by Lawsonia         proliferative
                  intracellularis.    enteropathies
                                      (ileitis). Not to be
                                      fed to swine that
                                      weigh more than 250
                                      lb.
------------------------------------------------------------------------
(iii) 100        1. For treatment    Feed as sole ration         000009
                  of swine            for 3 weeks or until       017800
                  dysentery.          signs of disease           043733
                                      disappear. Not to be
                                      fed to swine that
                                      weigh more than 250
                                      lb.
                 2. For control of   Feed as sole ration         000009
                  porcine             for 3 weeks or until
                  proliferative       signs of disease
                  enteropathies       disappear. Not to be
                  (ileitis) caused    fed to swine that
                  by Lawsonia         weigh more than 250
                  intracellularis.    lb.
------------------------------------------------------------------------
(iv) 200         For reduction in    Feed as sole ration         000009
                  the severity of     for 3 weeks. Not to        017800
                  swine mycoplasmal   be fed to swine that
                  pneumonia caused    weigh more than 250
                  by Mycoplasma       lb.
                  hyopneumoniae.
------------------------------------------------------------------------

    (3) Lincomycin may also be used in combination with:
    (i) Amprolium and ethopabate or amprolium and ethopabate with 
roxarsone in accordance with Sec.  558.58.
    (ii) Clopidol in accordance with Sec.  558.175.
    (iii) Decoquinate in accordance with Sec.  558.195.
    (iv) Fenbendazole as provided in Sec.  558.258.
    (v) Halofuginone in accordance with Sec.  558.265.
    (vi) Ivermectin as in Sec.  558.300.

[[Page 424]]

    (vii) Lasalocid alone or with roxarsone in accordance with Sec.  
558.311.
    (viii) Monensin alone or with roxarsone in accordance with Sec.  
558.355.
    (ix) Nicarbazin alone or with narasin or roxarsone as in Sec.  
558.366.
    (x) Pyrantel as in Sec.  558.485.
    (xi) Robenidine in accordance with Sec.  558.515.
    (xii) Roxarsone in accordance with Sec.  558.530.
    (xiii) Salinomycin with or without roxarsone as in Sec.  558.550.
    (xiv) Zoalene in accordance with Sec.  558.680.

[40 FR 13959, Mar. 27, 1975]

    Editorial Note: For Federal Register citations affecting Sec.  
558.325, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and on GPO Access.



Sec.  558.340  Maduramicin ammonium.

    (a) Approvals. Type A medicated articles: 4.54 grams per pound to 
046573 in Sec.  510.600(c) of this chapter.
    (b) Tolerances. See Sec.  556.375 of this chapter.
    (c) Conditions of use. (1) Amount. 4.54 to 5.45 grams per ton (5 to 
6 parts per million) (1 to 1.2 pounds per ton).
    (i) Indications for use. For prevention of coccidiosis caused by 
Eimeria acervulina, E. tenella, E. brunetti, E. maxima, E. necatrix, and 
E. mivati.
    (ii) Limitations. For broiler chickens only. Feed continuously as 
sole ration. Do not feed to laying hens. Withdraw 5 days before 
slaughter.
    (2) [Reserved]

[54 FR 5229, Feb. 2, 1989, as amended at 54 FR 26732, June 26, 1989; 54 
FR 32635, Aug. 9, 1989; 54 FR 33885, Aug. 17, 1989; 55 FR 23, Jan. 2, 
1990; 55 FR 8460, Mar. 8, 1990; 55 FR 49616, Nov. 30, 1990; 59 FR 8134, 
Feb. 18, 1994; 61 FR 18082, Apr. 24, 1996; 63 FR 27845, May 21, 1998; 66 
FR 46706, Sept. 7, 2001]



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) Approvals. See No. 000009 in Sec.  510.600(c) of this chapter.
    (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 Type B or C 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 Type B or C 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 positionally stable melengestrol acetate liquid Type B or C 
feed will not be subject to the requirements for mixing directions 
prescribed in paragraphs (c)(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) Combination Type B or C medicated feeds containing lasalocid 
must be labeled in accordance with Sec.  558.311(d)(5) of this chapter.
    (4) Liquid combination Type B or C medicated feeds containing 
melengestrol acetate and lasalocid must be manufactured in accordance 
with Sec.  558.311(d) of this chapter.
    (5) Combination Type B or C medicated feeds containing monensin must 
be labeled in accordance with Sec.  558.355(d) of this chapter.
    (6) Liquid combination Type B or C medicated feeds containing 
melengestrol acetate and monensin must be manufactured in accordance 
with Sec.  558.355(f)(3)(i) of this chapter.
    (7) Liquid combination Type B or C medicated feeds containing 
melengestrol acetate and tylosin must be manufactured in accordance with 
Sec.  558.625(c) of this chapter.

[[Page 425]]

    (8) Liquid melengestrol acetate may not be mixed with 
oxytetracycline in a common liquid feed supplement.
    (e) Conditions of use--(1) Cattle.

------------------------------------------------------------------------
 Melengestrol   Combination
acetate in mg/  in mg/head/   Indications for     Limitations    Sponsor
   head/day         day             use
------------------------------------------------------------------------
(i) 0.25 to    ............  Heifers fed in    Administer 0.5    000009
 0.5                          confinement for   to 2.0 pounds
                              slaughter: For    (lb)/head/day
                              increased rate    of medicated
                              of weight gain,   feed containing
                              improved feed     0.125 to 1.0 mg
                              efficiency, and   melengestrol
                              suppression of    acetate/lb to
                              estrus (heat).    provide 0.25 to
                                                0.5 mg
                                                melengestrol
                                                acetate/head/
                                                day.
(ii) 0.5       ............  Heifers intended  Administer 0.5    000009
                              for breeding:     to 2.0 lb/head/
                              For suppression   day of Type C
                              of estrus         feed containing
                              (heat).           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.
(iii) 0.25 to  Lasalocid     Heifers fed in    Add at the rate   000009
 0.5            100 to 360    confinement for   of 0.5 to 2.0
                              slaughter: As     lb/head/day a
                              in paragraph      medicated feed
                              (e)(1)(i) of      (liquid or dry)
                              this section.     containing
                                                0.125 to 1.0 mg
                                                melengestrol
                                                acetate/lb to a
                                                feed containing
                                                10 to 30 grams
                                                (g) of
                                                lasalocid per
                                                ton; or add at
                                                the rate of 0.5
                                                to 2.0 lb/head/
                                                day a medicated
                                                feed (liquid or
                                                dry) containing
                                                0.125 to 1.0 mg
                                                melengestrol
                                                acetate plus 50
                                                to 720 mg
                                                lasalocid/lb to
                                                a ration of
                                                nonmedicated
                                                feed to provide
                                                0.25 to 0.5 mg
                                                melengestrol
                                                acetate and 100
                                                to 360 mg
                                                lasalocid/head/
                                                day.
                                               Lasalocid
                                                provided by No.
                                                046573 in Sec.
                                                 510.600(c) of
                                                this chapter.
(iv) 0.25 to   Lasalocid     Heifers fed in    To administer     000009
 0.5            100 to 360    confinement for   0.25 to 0.5 mg
                plus          slaughter: As     melengestrol
                tylosin 90    in paragraph      acetate plus
                              (e)(1)(i) of      100 to 360 mg
                              this section;     lasalocid plus
                              and for reduced   90 mg tylosin/
                              incidence of      head/day:
                              liver            1. Add 0.5 to
                              abscesses.        2.0 lb/head/day
                                                of a liquid or
                                                dry medicated
                                                feed containing
                                                0.125 to 1.0 mg
                                                melengestrol
                                                acetate/lb to a
                                                medicated feed
                                                containing 10
                                                to 30 g
                                                lasalocid and 8
                                                to 10 g tylosin
                                                per ton; or
                                               2. Add 0.5 to
                                                2.0 lb/head/day
                                                of a liquid or
                                                dry medicated
                                                feed containing
                                                0.125 to 1.0 mg
                                                melengestrol
                                                acetate plus 50
                                                to 720 mg
                                                lasalocid/lb to
                                                4.5 to 18 lb of
                                                a dry medicated
                                                feed containing
                                                10 to 40 g
                                                tylosin per
                                                ton; or
                                               3. Add 0.5 to
                                                2.0 lb/head/day
                                                of a dry
                                                pelleted
                                                medicated feed
                                                containing
                                                0.125 to 1.0 mg
                                                melengestrol
                                                acetate (from a
                                                dry Type A
                                                article), 50 to
                                                720 mg
                                                lasalocid, and
                                                45 to 180 mg
                                                tylosin/lb to a
                                                ration of
                                                nonmedicated
                                                feed.
                                               Lasalocid
                                                provided by No.
                                                046573 and
                                                tylosin as
                                                tylosin
                                                phosphate by
                                                No. 000986 in
                                                Sec.
                                                510.600(c) of
                                                this chapter.

[[Page 426]]

 
(v) 0.25 to    Monensin 50   Heifers fed in    ................  000009
 0.4            to 360        confinement for  Add at the rate
                              slaughter: As     of 0.5 to 2.0
                              in paragraph      lb/head/day a
                              (e)(1)(i) of      medicated feed
                              this section.     (liquid or dry)
                                                containing
                                                0.125 to 0.80
                                                mg melengestrol
                                                acetate/lb to a
                                                feed containing
                                                5 to 30 g
                                                monensin per
                                                ton; or add at
                                                the rate of 0.5
                                                to 2.0 lb/head/
                                                day a medicated
                                                feed (liquid or
                                                dry) containing
                                                0.125 to 0.80
                                                mg melengestrol
                                                acetate plus 25
                                                to 720 mg
                                                monensin/lb to
                                                a nonmedicated
                                                feed to provide
                                                0.25 to 0.40 mg
                                                melengestrol
                                                acetate and 50
                                                to 360 mg
                                                monensin/head/
                                                day.
                                               Monensin
                                                provided by No.
                                                000986 in Sec.
                                                 510.600(c) of
                                                this chapter.
 (vi) 0.25 to  Monensin 50   Heifers fed in    ................  000009
 0.4            to 360        confinement for  Add at the rate
                              slaughter: As     of 0.5 to 2.0
                              in item           lb/head/day a
                              paragraph         medicated feed
                              (e)(1)(i) of      (liquid or dry)
                              this section;     containing
                              and for the       0.125 to 0.80
                              prevention and    mg melengestrol
                              control of        acetate/lb to a
                              coccidiosis due   feed containing
                              to Eimeria        10 to 30 g
                              bovis and E.      monensin per
                              zuernii.          ton; or add at
                                                the rate of 0.5
                                                to 2.0 lb/head/
                                                day a medicated
                                                feed (liquid or
                                                dry) containing
                                                0.125 to 0.80
                                                mg melengestrol
                                                acetate plus 25
                                                to 720 mg
                                                monensin/lb to
                                                a nonmedicated
                                                feed to provide
                                                0.25 to 0.40 mg
                                                melengestrol
                                                acetate and
                                                0.14 to 0.42 mg
                                                monensin/lb
                                                body weight, up
                                                to 360 mg
                                                monensin/head/
                                                day.
                                               Monensin
                                                provided by No.
                                                000986 in Sec.
                                                 510.600(c) of
                                                this chapter.
(vii) 0.25 to  Monensin 50   Heifers fed in    To administer     000009
 0.5            to 360 plus   confinement for   0.25 to 0.50 mg
                tylosin 60    slaughter: As     melengestrol
                to 90         in paragraph      acetate to 50
                              (e)(1)(i) of      to 360 mg
                              this section;     monensin plus
                              for the           60 to 90 mg
                              prevention and    tylosin/head/
                              control of        day:
                              coccidiosis due  1. Add 0.5 to
                              to E. bovis and   2.0 lb/head/day
                              E. zuernii; and   of a liquid or
                              for reduced       dry medicated
                              incidence of      feed containing
                              liver abscesses   0.125 to 1.0 mg
                              caused by         melengestrol
                              Fusobacterium     acetate/lb to a
                              necrophorum and   medicated feed
                              Actinomyces       containing 5 to
                              (Corynebacteriu   30 g monensin
                              m) pyogenes.      and 8 to 10 g
                                                tylosin per
                                                ton; or
                                               2. Add 0.5 to
                                                2.0 lb/head/day
                                                of a liquid or
                                                dry medicated
                                                feed containing
                                                0.125 to 1.0 mg
                                                melengestrol
                                                acetate plus 25
                                                to 720 mg
                                                monensin per
                                                pound to 4.5 to
                                                18 lb of a dry
                                                medicated feed
                                                containing 10
                                                to 40 g tylosin
                                                per ton; or
                                               3. Add 0.5 to
                                                2.0 lb/head/day
                                                of a liquid or
                                                dry medicated
                                                feed containing
                                                0.125 to 1.0 mg
                                                melengestrol
                                                acetate (from a
                                                dry Type A
                                                article), 25 to
                                                600 mg
                                                monensin, and
                                                45 to 180 mg
                                                tylosin/lb to a
                                                ration of
                                                nonmedicated
                                                feed.
                                               Monensin and
                                                tylosin as
                                                tylosin
                                                phosphate
                                                provided by No.
                                                000986 in Sec.
                                                 510.600(c) of
                                                this chapter.

[[Page 427]]

 
(viii) 0.25    Oxytetracycl  Heifers fed in    Add at the rate   000009
 to 0.5         ine 75        confinement for   of 0.5 to 2.0
                              slaughter: As     lb/head/day a
                              in paragraph      medicated feed
                              (e)(1)(i) of      (liquid or dry)
                              this section;     containing
                              and for           0.125 to 1.0 mg
                              reduction of      melengestrol
                              liver             acetate/lb per
                              condemnation      pound to a feed
                              due to liver      containing 6 to
                              abscesses.        10 g
                                                oxytetracycline
                                                per ton; or add
                                                at the rate of
                                                0.5 to 2.0 lb/
                                                head/day a dry
                                                medicated feed
                                                containing
                                                0.125 to 1.0 mg
                                                melengestrol
                                                acetate plus
                                                37.5 to 150 mg
                                                oxytetracycline/
                                                lb to provide
                                                0.25 to 0.5 mg
                                                melengestrol
                                                acetate and 75
                                                mg
                                                oxytetracycline/
                                                head/day.
                                               Oxytetracycline
                                                as provided by
                                                No. 066104 in
                                                Sec.
                                                510.600(c) of
                                                this chapter.
(ix) 0.25 to   Tylosin 60    Heifers fed in    To administer     000009
 0.5            to 90         confinement for   0.25 to 0.5 mg
                              slaughter: As     melengestrol
                              in paragraph      acetate with 60
                              (e)(1)(i) of      to 90 mg
                              this section;     tylosin/head/
                              and for reduced   day:
                              incidence of     1. Add 0.5 to
                              liver abscesses   2.0 lb/head/day
                              caused by F.      of a liquid or
                              necrophorum and   dry medicated
                              Actinomyces       feed containing
                              (Corynebacteriu   0.125 to 1.0 mg
                              m) pyogenes.      melengestrol
                                                acetate/lb to a
                                                medicated feed
                                                containing 8 to
                                                10 g tylosin
                                                per ton; or
                                               2. Add 0.5 to
                                                2.0 lb/head/day
                                                of a liquid or
                                                dry medicated
                                                feed containing
                                                0.125 to 1.0 mg
                                                melengestrol
                                                acetate/lb to
                                                4.5 to 18
                                                pounds of a dry
                                                medicated feed
                                                containing 10
                                                to 40 g tylosin
                                                per ton; or
                                               3. Add 0.5 to
                                                2.0 lb/head/day
                                                of a liquid or
                                                dry medicated
                                                feed containing
                                                0.125 to 1.0 mg
                                                melengestrol
                                                acetate (from a
                                                dry Type A
                                                article) plus
                                                45 to 180 mg
                                                tylosin/lb to a
                                                ration of
                                                nonmedicated
                                                feed.
                                               Tylosin as
                                                tylosin
                                                phosphate
                                                provided by No.
                                                000986 in Sec.
                                                 510.600(c) of
                                                this chapter.
------------------------------------------------------------------------

    (2) [Reserved]

[42 FR 28535, June 3, 1977, as amended at 46 FR 18967, Mar. 27, 1981; 49 
FR 39842, Oct. 11, 1984; 50 FR 1843, Jan. 14, 1985; 50 FR 16228, Apr. 
25, 1985; 51 FR 7398, Mar. 3, 1986; 51 FR 36222, Oct. 9, 1986; 52 FR 
2685, Jan. 26, 1987; 52 FR 33804, Sept. 8, 1987; 53 FR 27959, July 26, 
1988; 55 FR 31828, Aug. 6, 1990; 57 FR 5053, Feb. 12, 1992; 59 FR 41241, 
Aug. 11, 1994; 60 FR 11028, Mar. 1, 1995; 62 FR 8373, Feb. 25, 1997; 62 
FR 14304, Mar. 26, 1997; 63 FR 27845, May 21, 1998; 63 FR 41191, Aug. 3, 
1998; 63 FR 66018, Dec. 1, 1998; 67 FR 47688, July 22, 2002]



Sec.  558.348  Mibolerone.

    (a) Approvals. To No. 000009 in Sec.  510.600(c) of this chapter for 
a canned dog food, each 6\1/2\ ounce can containing 30 or 60 micrograms 
of mibolerone.
    (b) Conditions of use--(1) Amount. 30 micrograms for animals 
weighing up 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, or German Shepherds or 
German Shepherd mix weighing 30 to 80 pounds.
    (2) Indications for use. For the prevention of estrus (heat) in 
adult female dogs not intended primarily for breeding purposes.
    (3) Limitations. Administer daily at least 30 days before expected 
initiation of heat and continue as long as desired, but for not more 
than 12 months. Mibolerone should not be used in bitches before first 
estrous period or in purebred Bedlington terriers. It is not

[[Page 428]]

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.

[47 FR 6617, Feb. 16, 1982]



Sec.  558.355  Monensin.

    (a) Specifications. Monensin, as the base or the sodium salt, 
contains a minimum of 90 percent monensin activity derived from monensin 
A and a minimum of 95 percent derived from monensin A plus B. Using thin 
layer chromatography, the Rf value must be comparable to a 
reference standard (the Rf value is the distance the spots 
travel from the starting line divided by the distance the solvent front 
travels from the starting line), or, using High Performance Liquid 
Chromatography, the factor distribution of monensin Factor A or B is 
calculated as the percentage of total biopotency of all peaks. The loss 
on drying is not more than 10 percent when dried in vacuum at 60 [deg]C 
for 2 hours.
    (b) Approvals. Approvals for Type A medicated articles containing 
the specified levels of monensin activity granted to firms identified by 
sponsor numbers in Sec.  510.600(c) of this chapter for the conditions 
of use indicated in paragraph (f) of this section are as follows:
    (1) To 000986: 36.3 (for export only), 44, 45, or 60 grams per 
pound, paragraphs (f) (1)(i) and (4) of this section.
    (2) To 000986: 110 grams per lb., paragraphs (f)(1) (i), (iii), 
(iv), (v), (ix), and (x).
    (3) To 000986: 44 grams per lb. with 18 grams per lb. of roxarsone, 
110 grams per lb. with 45 grams per lb. of roxarsone, paragraph 
(f)(1)(ii).
    (4) To 000986: 45 and 60 grams per pound, as monensin sodium, 
paragraph (f)(2) of this section.
    (5) To 066104: 45 and 60 grams per pound, as monensin sodium 
provided by No. 000986, paragraphs (f)(1)(xiii), (xx), and (xxi) of this 
section.
    (6) To 000986: 45 and 60 grams per pound, as monensin sodium, 
paragraph (f)(5) of this section.
    (7) To 000986: 20, 30, 45, 60, 80, and 90.7 grams per pound, as 
monensin sodium, paragraph (f)(3) of this section.
    (8) To 046573: 45 and 60 grams per pound, as monensin sodium 
provided by No. 000986, paragraph (f)(1)(xiv) of this section.
    (9) To 046573: 45 and 60 grams per pound, as monensin sodium 
provided by No. 000986, paragraphs (f)(1)(xv) and (xvi) of this section.
    (10) To 057926: 45 and 60 grams per pound, as monensin sodium, 
paragraph (f)(1)(xvii) of this section.
    (11) To 046573: 45 and 60 grams per pound, as monensin sodium 
provided by No. 000986, paragraphs (f)(1)(xiv), (xviii), (xix), (xxiii), 
(xxiv), (xxv), (xxvi), and (xxvii) of this section.
    (12) To 066104: 45 and 60 grams per pound, as monensin sodium 
provided by No. 000986, paragraph (f)(1)(xxii) of this section.
    (13) To 021930: 60 and 80 grams per pound, paragraph (f)(3)(v) of 
this section.
    (14) To 000986: 60, 80, and 90.7 grams per pound, as monensin 
sodium, paragraph (f)(6) of this section.
    (c) [Reserved]
    (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) Type C cattle feeds containing 30 grams or less monensin sodium 
per ton shall bear an expiration date of 30 days after its date of 
manufacture.
    (3) Type C goat feeds shall bear an expiration date of 30 days after 
date of manufacture.
    (4) [Reserved]
    (5) Liquid Type B feeds shall bear an expiration date of 8 weeks 
after its date of manufacture.
    (6) The labeling of 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) The labeling of all Type A articles and Type B feeds (liquid and 
dry) containing monensin intended for use in cattle shall bear, in 
addition to the caution statement in paragraph (d)(6) of this section, 
the following caution statements:
    (i) Monensin medicated cattle feed is safe for use in cattle only. 
Consumption by unapproved species may result in toxic reactions;

[[Page 429]]

    (ii) Feeding undiluted or mixing errors resulting in high 
concentrations of monensin has been fatal to cattle.
    (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 dairy cows.
    (8) The labeling of complete feeds containing monensin intended for 
use in cattle shall bear the caution statements specified in paragraphs 
(d) (6) and (7) (i) and (v) of this section.
    (9) The labeling of Type A articles containing monensin intended for 
use in chickens shall bear the caution statements specified in 
paragraphs (d) (6) and (7) (iii) and (iv) of this section.
    (10) The labeling of all Type A articles and Type B feeds (liquid 
and dry) containing monensin intended for use in goats shall bear, in 
addition to the caution statement in paragraph (d)(6) of this section, 
the following caution statements:
    (i) Monensin medicated goat feed is safe for use in goats only. 
Consumption by unapproved species may result in toxic reactions.
    (ii) Feeding undiluted or mixing errors resulting in high 
concentrations of monensin 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.
    (11) The labeling of complete feeds containing monensin intended for 
use in goats shall bear the caution statements specified in paragraphs 
(d)(6) and (d)(10) (i) and (v) of this section.
    (e) Related tolerances. See Sec.  556.420 of this chapter.
    (f) Conditions of use. It is used as follows:
    (1) Broiler chickens--(i) Amount per ton. Monensin, 90-110 grams.
    (a) Indications for use. As an aid in the prevention of coccidiosis 
caused by E. necatrix, E. tenella, E. acervulina, E. brunetti, E. 
mivati, and E. maxima.
    (b) Limitations. Do not feed to laying chickens; feed continuously 
as the sole ration; in the absence of coccidiosis, the use of monensin 
with no withdrawal period may limit feed intake resulting in reduced 
weight gain; as monensin or monensin sodium.
    (ii) Amount per ton. Monensin, 90-110 grams, plus roxarsone 45.4 
grams (0.005 percent).
    (a) Indications for use. Growth promotion and feed efficiency, 
improving pigmentation; as an aid in the prevention of coccidiosis 
caused by E. necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati 
and E. maxima.
    (b) Limitations. Do not feed to laying chickens; feed continuously 
as the sole ration; withdraw 5 days before slaughter; as sole source of 
organic arsenic; as monensin or monensin sodium.
    (iii) Amount per ton. Monensin, 90-110 grams plus bacitracin, 5-25 
grams.
    (a) Indications for use. For increased rate of weight gain and 
improved feed efficiency; as an aid in the prevention of coccidiosis 
caused by E. necatrix, E. tenella, E. acervulina, E. brunetti, E. 
mivati, and E. maxima.
    (b) Limitations. Do not feed to laying chickens; feed continuously 
as sole ration; in the absence of coccidiosis, the use of monensin with 
no withdrawal period may limit feed intake resulting in reduced weight 
gain; as bacitracin methylene disalicylate provided by No. 046573 in 
Sec.  510.600(c) of this chapter; as monensin sodium.
    (iv) Amount per ton. Monensin, 90-110 grams plus bacitracin, 10 
grams.
    (a) Indications for use. For increased rate of weight gain and 
improved feed efficiency; as an aid in the prevention of coccidiosis 
caused by E. necatrix, E. tenella, E. acervulina, E. brunetti, E. 
mivati, and E. maxima.
    (b) Limitations. Do not feed to laying chickens; feed continuously 
as sole ration; in the absence of coccidiosis, the use of monensin with 
no withdrawal period may limit feed intake resulting in reduced weight 
gain; as zinc bacitracin provided by No. 046573 in Sec.  510.600(c) of 
this chapter; as monensin sodium.
    (v) Amount per ton. Monensin, 90-110 grams plus bacitracin, 10-30 
grams.

[[Page 430]]

    (a) Indications for use. For improved feed efficiency; as an aid in 
the prevention of coccidiosis caused by E. necatrix, E. tenella, E. 
acervulina, E. brunetti, E. mivati, and E. maxima.
    (b) Limitations. Do not feed to laying chickens; feed continuously 
as sole ration; in the absence of coccidiosis, the use of monensin with 
no withdrawal period may limit feed intake resulting in reduced weight 
gain; as zinc bacitracin provided by No. 046573 in Sec.  510.600(c) of 
this chapter; as monensin sodium.
    (vi) Amount per ton. Monensin, 90 to 110 grams plus bambermycins, 1 
to 2 grams. See Sec.  558.95(b)(1)(vi).
    (vii) Amount per ton. Monensin, 90 to 110 grams plus bambermycins, 1 
gram plus roxarsone, 22.7 to 45.4 grams (.0025 to .005 percent). See 
Sec.  558.95(b)(1)(vii).
    (viii) Amount per ton. Monensin, 90 to 110 grams plus 
oxytetracycline, 200 grams.
    (a) Indications for use. As an aid in the prevention of coccidiosis 
caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. 
mivati, and E. maxima; and for the control of complicated chronic 
respiratory disease (CRD or air-sac infection) caused by Mycoplasma 
gallisepticum and Escherichia coli.
    (b) Limitations. In the absence of coccidiosis, the use of monensin 
with no withdrawal period may limit feed intake resulting in reduced 
weight gain; do not feed to laying chickens; feed continuously as sole 
ration; as monensin sodium.
    (ix) Amount per ton. Monensin, 90-110 grams plus lincomycin, 2 
grams.
    (a) Indications for use. For increase in rate of weight gain and 
improved feed efficiency; as an aid in the prevention of coccidiosis 
caused by E. necatrix, E. tenella, E. acervulina, E. brunetti, E. 
mivati, and E. maxima.
    (b) Limitations. Do not feed to laying chickens; to be fed as a sole 
ration; in the absence of coccidiosis, the use of monensin with no 
withdrawal period may limit feed intake resulting in reduced weight 
gain; as monensin sodium.
    (x) Amount per ton. Monensin, 90-110 grams plus lincomycin, 2 grams 
and roxarsone, 15-45 grams.
    (a) Indications for use. For increase in rate of weight gain; as an 
aid in the prevention of coccidiosis caused by E. necatrix, E. tenella, 
E. acervulina, E. brunetti, E. mivati, and E. maxima.
    (b) Limitations. Do not feed to laying chickens; feed continuously 
as the sole ration; withdraw 5 days before slaughter; as sole source of 
organic arsenic; as roxarsone provided by No. 046573, Sec.  510.600(c) 
of this chapter; as monensin sodium provided by No. 000986, Sec.  
510.600(c) of this chapter; as lincomycin provided by No. 000009, Sec.  
510.600(c) of this chapter; as a combination provided by No. 000009, 
Sec.  510.600(c) of this chapter.
    (xi) Amount per ton. Monensin, 90 to 110 grams, plus lincomycin, 2 
grams and roxarsone, 15 to 30 grams.
    (a) Indications for use. For increase in rate of weight gain, 
improved feed efficiency, improved pigmentation, and as an aid in the 
prevention of coccidiosis caused by E. necatrix, E. tenella, E. 
acervulina, E. brunetti, E. mivati and E. maxima.
    (b) Limitations. Do not feed to laying chickens; feed continuously 
as the sole ration; withdraw 5 days before slaughter; as sole source of 
organic arsenic; as roxarsone provided by No. 046573 in Sec.  510.600(c) 
of this chapter; as monensin sodium provided by No. 000986 in Sec.  
510.600(c) of this chapter; as lincomycin provided by No. 000009 in 
Sec.  510.600(c) of this chapter; as a combination provided by No. 
000009 in Sec.  510.600(c) of this chapter.
    (xii) Amount per ton. Monensin, 90 to 110 grams, plus bacitracin 
methylene disalicylate, 10 to 25 grams, and roxarsone, 11.3 to 45.4 
grams.
    (a) Indications for use. As an aid in the prevention of coccidiosis 
caused by E. necatrix, E. tenella, E. acervulina, E. brunetti, E. 
maxima, and E. mivati; for increased rate of weight gain and for 
improved feed efficiency.
    (b) Limitations. Do not feed to laying chickens; feed continuously 
as sole ration; withdraw 5 days before slaughter; as sole source of 
organic arsenic; as monensin sodium provided by No. 000986 in Sec.  
510.600 of this chapter; as bacitracin methylene disalicylate provided 
by No. 046573 in Sec.  510.600 of this chapter; as roxarsone provided by 
No.

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011526 or 046573 in Sec.  510.600 of this chapter.
    (xiii) Amount per ton. Monensin, 90 to 110 grams, plus 5 grams 
virginiamycin.
    (a) Indications for use. As an aid in the prevention of coccidiosis 
caused by E. necatrix, E. tenella, E. acervulina, E. brunetti, E. 
maxima, and E. mivati; for increased rate of weight gain and improved 
feed efficiency.
    (b) Limitations. Do not feed to laying chickens; feed continuously 
as sole ration; as monensin sodium provided by No. 000986 in Sec.  
510.600 of this chapter; virginiamycin provided by No. 066104 in Sec.  
510.600 of this chapter.
    (xiv) Amount per ton. Monensin, 90 to 110 grams, plus 500 grams 
chlortetracycline.
    (a) Indications for use. As an aid in the reduction of mortality due 
to Escherichia coli infections susceptible to such treatment. As an aid 
in the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, 
E. acervulina, E. brunetti, E. mivati, and E. maxima.
    (b) Limitations. Do not feed to laying chickens; feed for 5 days as 
the sole ration; withdraw 24 hours before slaughter; in the absence of 
coccidiosis, the use of monensin with no withdrawal period may limit 
feed intake resulting in reduced weight gain; not to be fed continuously 
for more than 5 days; as monensin sodium; as chlortetracycline 
hydrochloride provided by No. 046573 in Sec.  510.600(c) of this 
chapter.
    (xv) Amount per ton. Monensin, 90 to 110 grams, plus bacitracin 
zinc, 10 grams, and roxarsone, 15 grams (0.0017 percent).
    (a) Indications for use. For increase in rate of weight gain; for 
the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. 
acervulina, E. maxima, E. brunetti, and E. mivati.
    (b) Limitations. Do not feed to laying chickens; feed continuously 
as the sole ration; withdraw 5 days before slaughter; as sole source of 
organic arsenic; feed must be used within 4 weeks of manufacture; as 
monensin sodium; as bacitracin zinc provided by No. 046573 in Sec.  
510.600(c) of this chapter; as roxarsone provided by No. 046573 in Sec.  
510.600(c) of this chapter.
    (xvi) Amount per ton. Monensin, 90 to 110 grams, plus bacitracin 
zinc, 4 to 50 grams, and roxarsone, 15 to 45.4 grams (0.0017 percent to 
0.005 percent).
    (a) Indications for use. For improved feed efficiency; for improved 
pigmentation by enhancing carotenoid and xanthophyll utilization; for 
the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. 
acervulina, E. maxima, E. brunetti, and E. mivati.
    (b) Limitations. Do not feed to laying chickens; feed continuously 
as the sole ration; withdraw 5 days before slaughter; as sole source of 
organic arsenic; feed must be used within 4 weeks of manufacture; as 
monensin sodium; as bacitracin zinc provided by No. 046573 in Sec.  
510.600(c) of this chapter; as roxarsone provided by No. 046573 in Sec.  
510.600(c) of this chapter.
    (xvii) Amount per ton. Monensin, 90 to 110 grams plus bambermycins, 
1 to 2 grams plus roxarsone, 22.7 to 45.4 grams (0.0025 to 0.005 
percent). See Sec.  558.95(b)(1)(xiii) of this chapter.
    (xviii) Amount per ton. Monensin, 90 to 110 grams, plus bacitracin 
methylene disalicylate, 50 grams, and roxarsone, 22.7 to 34.0 grams 
(0.0025 percent to .00375 percent).
    (a) Indications for use. For increase in rate of weight gain and 
improved feed efficiency; as an aid in the prevention of coccidiosis 
caused by Eimeria necatrix, E. tenella, E. acervulina, E. maxima, E. 
brunetti, and E. mivati; as an aid in the prevention of necrotic 
enteritis caused or complicated by Clostridium spp or other organisms 
susceptible to bacitracin methylene disalicylate.
    (b) Limitations. Do not feed to laying chickens; feed continuously 
as the sole ration; withdraw 5 days before slaughter; as sole source of 
organic arsenic; as monensin sodium provided by No. 000986 in Sec.  
510.600(c) of this chapter; as bacitracin methylene disalicylate 
provided by No. 046573 in Sec.  510.600(c) of this chapter; as roxarsone 
provided by No. 046573 in Sec.  510.600(c) of this chapter.
    (xix) Amount per ton. Monensin, 90 to 110 grams, plus bacitracin 
methylene disalicylate, 50 grams, and roxarsone, 22.7 to 45.4 grams 
(0.0025 percent to .005 percent).
    (a) Indications for use. For increased rate of weight gain; as an 
aid in the prevention of necrotic enteritis caused or complicated by 
Clostridium spp or

[[Page 432]]

other organisms susceptible to bacitracin methylene disalicylate; as an 
aid in the prevention of coccidiosis caused by Eimeria necatrix, E. 
tenella, E. acervulina, E. maxima, E. brunetti, and E. mivati.
    (b) Limitations. Do not feed to laying chickens; feed continuously 
as the sole ration; withdraw 5 days before slaughter; as sole source of 
organic arsenic; as monensin sodium provided by No. 000986 in Sec.  
510.600(c) of this chapter; as bacitracin methylene disalicylate 
provided by No. 046573 in Sec.  510.600(c) of this chapter; as roxarsone 
provided by No. 046573 in Sec.  510.600(c) of this chapter.
    (xx) Amount per ton. Monensin, 90 to 110 grams, plus virginiamycin, 
5 to 15 grams, and roxarsone, 22.7 grams (0.0025 percent).
    (a) Indications for use. For incease in rate of weight gain; as an 
aid in the prevention of coccidiosis caused by Eimeria necatrix, E. 
tenella, E. acervulina, E. maxima, E. brunetti, and E. mivati.
    (b) Limitations. Do not feed to laying chickens; feed continuously 
as the sole ration; withdraw 5 days before slaughter; as sole source of 
organic arsenic; as monensin sodium provided by No. 000986 in Sec.  
510.600(c) of this chapter; as virginiamycin provided by No. 066104 in 
Sec.  510.600(c) of this chapter; roxarsone provided by Nos. 046753 and 
011526 in Sec.  510.600(c) of this chapter.
    (xxi) Amount per ton. Monensin, 90 to 110 grams, plus virginiamycin, 
5 to 15 grams.
    (a) Indications for use. For increase in rate of weight gain; as an 
aid in the prevention of coccidiosis caused by Eimeria necatrix, E. 
tenella, E. acervulina, E. maxima, E. brunetti, and E. mivati.
    (b) Limitations. Do not feed to laying chickens; feed continuously 
as sole ration; as monensin sodium provided by No. 000986 in Sec.  
510.600 of this chapter; virginiamycin provided by No. 066104 in Sec.  
510.600 of this chapter.
    (xxii) Amount per ton. Monensin, 90 to 110 grams plus 
oxytetracycline, 500 grams.
    (a) Indications for use. As an aid in the prevention of coccidiosis 
caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. 
Mivati, and E. maxima; as an aid in the reduction of mortality due to 
air-sacculities (air-sac infection) caused by Escherichia coli sensitive 
to oxytetracycline.
    (b) Limitations. Feed for 5 days as sole ration. Do not feed to 
laying chickens. Withdraw 24 hours before slaughter. As monensin sodium 
provided by No. 000986 in Sec.  510.600(c) of this chapter. As mono-
alkyl (C8-C18) trimethylammonium oxytetracycline 
provided by No. 066104 in Sec.  510.600(c) of this chapter.
    (xxiii) Amount per ton. Monensin, 90 to 110 grams, plus bacitracin 
zinc, 4 to 50 grams, and roxarsone, 22.7 to 45.4 grams (0.0025 percent 
to 0.005 percent).
    (a) Indications for use. For improved feed efficiency; as an aid in 
the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. 
acervulina, E. maxima, E. brunetti, and E. mivati.
    (b) Limitations. Do not feed to laying chickens; feed continuously 
as the sole ration; withdraw 5 days before slaughter; as sole source of 
organic arsenic; as monensin sodium provided by No. 000986 in Sec.  
510.600(c) of this chapter; as bacitracin zinc provided by No. 046573 in 
Sec.  510.600(c) of this chapter; as roxarsone provided by No. 046573 in 
Sec.  510.600(c) of this chapter.
    (xxiv) Amount per ton. Monensin, 90 to 110 grams, plus bacitracin 
methylene disalicylate, 4 to 50 grams.
    (xxv) Amount per ton. Monensin, 90 to 110 grams plus bacitracin, 4 
to 50 grams.
    (a) Indications for use. For increased rate of weight gain and 
improved feed efficiency; as an aid in the prevention of coccidiosis 
caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. 
mivati, and E. maxima.
    (b) Limitations. Do not feed to laying chickens; feed continuously 
as sole ration; in the absence of coccidiosis, the use of monensin with 
no withdrawal period may limit feed intake resulting in reduced weight 
gain; as bacitracin zinc provided by No. 046573 in Sec.  510.600(c) of 
this chapter, as monensin sodium.
    (xxvi) Amount per ton. Monensin 90 to 110 grams plus bacitracin 100 
to 200 grams and roxarsone 22.7 to 34.0 grams.
    (a) Indications for use. As an aid in the control of necrotic 
enteritis caused or complicated by Clostridium spp. or

[[Page 433]]

other organisms susceptible to bacitracin methylene disalicylate; as an 
aid in the prevention of coccidiosis caused by Eimeria tenella, E. 
necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati; for 
increased rate of weight gain and improved feed efficiency.
    (b) Limitations. For broiler chickens only. Feed continuously as 
sole ration. Use as sole source of organic arsenic. Withdraw 5 days 
before slaughter. Do not feed to laying hens. To control necrotic 
enteritis, start medication at first clinical signs of disease. The 
dosage range permitted provides for different levels based on the 
severity of infection. Use continuously for 5 to 7 days or as long as 
clinical signs persist, then reduce dosage to prevention level. Animals 
should have access to drinking water at all times. Drug overdosage or 
lack of water may result in leg weakness. As roxarsone and bacitracin 
methylene disalicylate provided by No. 046573 in Sec.  510.600(c) of 
this chapter.
    (xxvii) Amount per ton. Monensin 90 to 110 grams plus bacitracin 100 
to 200 grams and roxarsone 22.7 to 45.4 grams.
    (a) Indications for use. As an aid in the control of necrotic 
enteritis caused or complicated by Clostridium spp. or other organisms 
susceptible to bacitracin methylene disalicylate; as an aid in the 
prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. 
acervulina, E. maxima, E. brunetti, and E. mivati; for increased rate of 
weight gain.
    (b) Limitations. For broiler chickens only. Feed continuously as 
sole ration. Use as sole source of organic arsenic. Withdraw 5 days 
before slaughter. Do not feed to laying hens. To control necrotic 
enteritis, start medication at first clinical signs of disease. The 
dosage range permitted provides for different levels based on the 
severity of infection. Use continuously for 5 to 7 days or as long as 
clinical signs persist, then reduce dosage to prevention level. Animals 
should have access to drinking water at all times. Drug overdosage or 
lack of water may result in leg weakness. As roxarsone and bacitracin 
methylene disalicylate provided by No. 046573 in Sec.  510.600(c) of 
this chapter.
    (xxviii) Amount per ton. Monensin, 90 to 110 grams, plus tylosin 
phosphate, 4 to 50 grams.
    (a) Indications for use. As an aid in the prevention of coccidiosis 
caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. 
mivati, and E. maxima, for increased rate of weight gain, and improved 
feed efficiency.
    (b) Limitations. Feed continuously as sole ration. In the absence of 
coccidiosis, the use of monensin with no withdrawal period may limit 
feed intake resulting in reduced weight gain. Do not feed to laying 
chickens. As monensin sodium and tylosin phosphate provided by No. 
000986 in Sec.  510.600(c) of this chapter.
    (xxix) Amount per ton. Monensin, 90 to 110 grams; plus bacitracin 
methylene disalicylate, 50 grams.
    (a) Indications for use. As an aid in the prevention of coccidiosis 
caused by E. necatrix, E. tenella, E. acervulina, E. brunetti, E. 
mivati, and E. maxima; and as an aid in the prevention of necrotic 
enteritis caused or complicated by Clostridium spp. or other organisms 
susceptible to bacitracin.
    (b) Limitations. Feed continuously as sole ration. Do not feed to 
chickens over 16 weeks of age. Do not feed to laying chickens. As 
monensin sodium provided by 000986; bacitracin methylene disalicylate as 
provided by 046573 in Sec.  510.600(c) of this chapter.
    (xxx) Amount per ton. Monensin, 90 to 110 grams; plus bacitracin 
methylene disalicylate, 100 to 200 grams.
    (a) Indications for use. As an aid in the prevention of coccidiosis 
caused by E. necatrix, E. tenella, E. acervulina, E. brunetti, E. 
mivati, and E. maxima; and as an aid in the control of necrotic 
enteritis caused or complicated by Clostridium spp. or other organisms 
susceptible to bacitracin.
    (b) Limitations. Feed continuously as sole ration. Do not feed to 
chickens over 16 weeks of age. Do not feed to laying chickens. To 
control necrotic enteritis, start medication at first clinical signs of 
disease; vary dosage based on the severity of infection; administer 
continuously for 5 to 7 days or as long as clinical signs persist, then 
reduce bacitracin to prevention level (50 grams per ton). As monensin 
sodium provided by 000986; bacitracin methylene disalicylate as provided 
by 046573 in Sec.  510.600(c) of this chapter.

[[Page 434]]

    (2) Turkeys--(i) Amount per ton. Monensin, 54 to 90 grams.
    (a) Indications for use. For the prevention of coccidiosis in 
turkeys caused by E. adenoeides, E. meleagrimitis, and E. gallopavonis.
    (b) Limitations. For growing turkeys only; as monensin sodium; feed 
continuously as sole ration. 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. Some strains of 
turkey coccidia may be monensin tolerant or resistant. Monensin may 
interfere with development of immunity to turkey coccidiosis.
    (ii) Amount per ton. Monensin, 54 to 90 grams, and bacitracin 
methylene disalicylate, 4 to 50 grams.
    (a) Indications for use. For prevention of coccidiosis caused by 
Eimeria adenoeides, E. meleagrimitis, and E. gallopavonis, for increased 
rate of weight gain, and for improved feed efficiency.
    (b) Limitations. For growing turkeys only; as monensin sodium; feed 
continuously as sole ration. 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. Some strains of 
turkey coccidia may be monensin tolerant or resistant. Monensin may 
interfere with development of immunity to turkey coccidiosis. Bacitracin 
methylene disalicylate as provided by No. 046573 in Sec.  510.600(c) of 
this chapter.
    (iii) Amount per ton. Monensin, 54 to 90 grams, and bacitracin 
methylene disalicylate, 200 grams.
    (a) Indications for use. For the prevention of coccidiosis caused by 
Eimeria adenoides, E. meleagrimitis, and E. gallopavonis, and as an aid 
in the control of transmissible enteritis complicated by organisms 
susceptible to bacitracin methylene disalicylate.
    (b) Limitations. For growing turkeys only; as monensin sodium; feed 
continuously as sole ration. 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. Some strains of 
turkey coccidia may be monensin tolerant or resistant. Monensin may 
interfere with development of immunity to turkey coccidiosis. Bacitracin 
methylene disalicylate as provided by No. 046573 in Sec.  510.600(c) of 
this chapter.
    (iv) Amount per ton. Monensin, 54 to 90 grams, with virginiamycin, 
10 to 20 grams.
    (a) Indications for use. For the prevention of coccidiosis caused by 
Eimeria adenoeides, E. meleagrimitis, and E. gallopavonis, and for 
increased rate of weight gain and improved feed efficiency in growing 
turkeys.
    (b) Limitations. For growing turkeys only. Feed continuously as sole 
ration. Do not allow horses, other equines, mature turkeys, or guinea 
fowl access to feed containing monensin. Ingestion of monensin by 
horses, mature turkeys, and guinea fowl has been fatal. Some strains of 
turkey coccidia may be monensin tolerant or resistant. Monensin may 
interfere with development of immunity to turkey coccidiosis. 
Virginiamycin as provided by No. 066104 in Sec.  510.600(c) of this 
chapter.
    (v) Amount per ton. Monensin, 54 to 90 grams, plus bambermycins, 1 
to 2 grams.
    (a) Indications for use. For the prevention of coccidiosis in 
turkeys caused by E. adenoeides, E. meleagrimitis, and E. gallopavonis, 
and for improved feed efficiency in growing turkeys.
    (b) Limitations. For growing turkeys only. Feed continuously as sole 
ration. Some strains of turkey coccidia may be monensin tolerant or 
resistant. Monensin may interfere with development of immunity to turkey 
coccidiosis. Bambermycins as provided by No. 057926 in Sec.  510.600(c) 
of this chapter.
    (vi) Amount per ton. Monensin, 54 to 90 grams, plus bambermycins, 2 
grams.
    (a) Indications for use. For the prevention of coccidiosis in 
turkeys caused by E. adenoeides, E. meleagrimitis, and E. gallopavonis, 
and for increased rate of weight gain and improved feed efficiency in 
growing turkeys.
    (b) Limitations. For growing turkeys only. Feed continuously as sole 
ration. Some strains of turkey coccidia may be monensin tolerant or 
resistant.

[[Page 435]]

Monensin may interfere with development of immunity to turkey 
coccidiosis. Bambermycins as provided by No. 057926 in Sec.  510.600(c) 
of this chapter.
    (3) Cattle--(i) Amount per ton. Monensin, 5-30 grams.
    (a) Indications for use. Improved feed efficiency.
    (b) Limitations. (1) Feed only to cattle being fed in confinement 
for slaughter. Feed continuously in complete feed at a rate of 50 to 360 
milligrams of monensin per head per day; as monensin sodium. Complete 
feeds may be manufactured from monensin liquid Type B feeds. The liquid 
Type B feeds have a pH of 4.3 to 7.1 and their labels must bear 
appropriate mixing directions. Mixing directions for liquid Type B feeds 
stored in recirculating tank systems are: 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 directed in this paragraph, even when Type B feed 
is not used. Mixing directions for liquid Type B feeds stored in 
mechanical, air, or other agitation-type tank systems are: 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 directed in this paragraph, even when Type B feed is not used. 
The liquid Type B feed must bear directions to mix thoroughly with grain 
and/or roughage prior to feeding and must bear caution statements as 
follows: Inadequate mixing, (recirculation or agitation), of liquid Type 
B feeds has resulted in increased monensin concentration which has been 
fatal to cattle.
    (2) An approved positionally stable monensin liquid Type B feed will 
not be subject to the requirements for mixing directions and cautionary 
labeling prescribed in paragraph (f)(3)(i)(b)(1) of this section. A 
manufacturer may secure approval of a positionally stable liquid Type B 
feed by (i) either filing an NADA for the product or by 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 NADA to establish 
positional stability; and (iii) requesting No. 000986 in Sec.  
510.600(c) of this chapter to file a supplemental NADA to provide for 
the use of its monensin Type A article in the manufacture of the liquid 
Type B feed specified in the appropriate master file. If the data 
demonstrate the stability of the liquid Type B feed described in the 
master file, the agency will approve the supplemental NADA. Approval of 
the Type B feed need not be published in the Federal Register because 
approval will not affect or alter the content of the regulation. The 
approval will, however, provide a basis for the individual liquid feed 
manufacturer to submit, and for the agency to approve, a medicated feed 
application under section 512(m) of the act for the liquid Type B feed. 
A manufacturer who seeks to market a positionally unstable monensin 
liquid Type B feed with mixing directions different from the standard 
established in paragraph (f)(3)(i)(b)(1) of this section may also follow 
this procedure.
    (ii) Amount per ton. Monensin, 5 to 30 grams, plus tylosin, 8 to 10 
grams.
    (a) Indications for use. Improved feed efficiency; for reduction of 
incidence of liver abscesses caused by Fusobacterium necrophorum and 
Actinomyces (Corynebacterium) pyogenes.
    (b) Limitations. Feed only to cattle being fed in confinement for 
slaughter. Feed continuously as sole ration at the rate of 50 to 360 
milligrams of monensin and 60 to 90 milligrams of tylosin per head per 
day; as monensin sodium; as tylosin phosphate. Combination drug liquid 
Type B medicated feeds may be used to manufacture dry Type C medicated 
feeds and shall conform to mixing instructions as in Sec.  558.625 (c).
    (iii) Amount per ton. Monensin, 25 to 400 grams.
    (a) Indications for use. For increased rate of weight gain; for 
prevention and control of coccidiosis due to Eimeria bovis and E. 
zuernii.
    (b) Limitations. Feed to pasture cattle (slaughter, stocker, feeder, 
and dairy and beef replacement heifers). For increased rate of weight 
gain, feed at a rate of 50 to 200 milligrams monensin per head per day 
in not less than 1 pound of feed or, after the 5th day, feed

[[Page 436]]

at a rate of 400 milligrams per head per day every 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.
    (iv) [Reserved]
    (v) Amount. 150 milligrams per pound (0.033 percent).
    (a) Indications for use. For increased rate of weight gain and for 
prevention and control of coccidiosis caused by Eimeria bovis and E. 
zuernii.
    (b) Limitations. As protein-mineral blocks to be fed free choice to 
cattle (slaughter, stocker, feeder, and dairy and beef replacement 
heifers) on pasture which may require supplemental feed. Provide 50 to 
200 milligrams of monensin (0.34 to 1.33 pounds) per head per day, at 
least 1 block per 10 to 12 head of cattle. Roughage must be available at 
all times. Do not allow animals access to other protein blocks, salt or 
mineral, while being fed this product. Do not allow horses or other 
equines access to formulations containing monensin (ingestion of 
monensin by equines has been fatal). Block's effectiveness in cull cows 
and bulls has not been established. Approval must comply with Sec.  
510.455 of this chapter.
    (vi) Amount per ton. Monensin, 25 to 400 grams.
    (a) Indications for use. For improved feed efficiency; for 
prevention and control of coccidiosis due to E. bovis and E. zuernii.
    (b) Limitations. Feed to mature reproducing beef cows. Feed as 
supplemental feed, either hand-fed in a minimum of 1 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.
    (vii) Amount per ton. Monensin, 10 to 30 grams.
    (a) Indications for use. For improved feed efficiency; for 
prevention and control of coccidiosis due to E. bovis and E. zuernii.
    (b) Limitations. For feedlot cattle, feed continuously to provide 50 
to 360 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 the severity of challenge, up to 
maximum of 360 milligrams per head per day.
    (viii) Additional combinations. Monensin may be used for heifers 
being fed in confinement for slaughter with melengestrol acetate with or 
without tylosin as in Sec.  558.342.
    (ix) Amount. To 000986: To make liquid Type B medicated feed 
containing 400 grams per ton monensin sodium with 150 grams per ton 
tylosin phosphate used to make a dry Type C medicated feed containing 
21.4 to 26.8 grams per ton monensin plus 8 to 10 grams per ton tylosin.
    (a) Indications for use. Improved feed efficiency; for reduction of 
incidence of liver abscesses caused by Fusobacterium necrophorum and 
Actinomyces (Corynebacterium) pyogenes.
    (b) Limitations. Feed only to cattle being fed in confinement for 
slaughter. Feed continuously at the rate of 8.2 to 10.2 kilograms (18 to 
22.5 pounds) of Type C medicated feed per head per day to supply 240 
milligrams of monensin and 90 milligrams of tylosin per head per day; as 
monensin sodium; as tylosin phosphate. Do not allow horses or other 
equines access to feeds containing monensin. Ingestion of monensin by 
equines has been fatal. Safe use in unapproved species and breeding 
cattle has not been established. The liquid Type B medicated feed must 
bear an expiration date of 14 days after date of manufacture. The mixing 
directions for this liquid Type B medicated feed stored in recirculation 
or agitation tank systems are: Recirculate or agitate immediately prior 
to use for not less than 10 minutes, moving at least 1 percent of the 
tanks contents per minute from the bottom of the tank to the top. 
Recirculate or agitate as directed daily, even when

[[Page 437]]

the Type B medicated feed is not used. Inadequate mixing (recirculation 
or agitation) of liquid Type B medicated feeds may result in increased 
monensin concentrations which have been fatal to cattle. Both an 
approved NADA and an approved medicated feed application are required to 
make this liquid Type B medicated feed.
    (x) Amount per ton. Monensin, 1,620 grams as monensin sodium (810 
milligrams per pound).
    (a) Indications for use. For increased rate of weight gain; and for 
prevention and control of coccidiosis caused by Eimeria bovis and E. 
zuernii in pasture cattle (slaughter, stocker, feeder, and dairy and 
beef replacement heifers).
    (b) Specifications. Use as free-choice Type C medicated feed 
formulated as mineral granules as follows:

----------------------------------------------------------------------------------------------------------------
                           Ingredient                              Percent          International feed no.
----------------------------------------------------------------------------------------------------------------
Monocalcium phosphate (21% phosphorus, 15% calcium)                   29.49                            6-01-082
Sodium chloride (salt)                                                24.25                            6-04-152
Dried cane molasses                                                   20.0                             4-04-695
Ground limestone (33% calcium) or calcium carbonate (38%              13.75                            6-02-632
 calcium)
Cane molasses                                                          3.0                             4-04-696
Processed grain by-products (as approved by AAFCO)                     5.0
Vitamin/trace mineral premix\1\                                        2.5
Monensin Type A article, 80 grams per pound                            1.01
Antidusting oil                                                        1.0
----------------------------------------------------------------------------------------------------------------
\1\Content of the 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. The amount of
  selenium and ethylenediamine dihydroiodide (EDDI) must comply with the published requirements. (For selenium
  see 21 CFR 573.920; for EDDI see 51 FR 11483 (April 3, 1986).)

    (c) Limitations. For free-choice feeding to pasture cattle 
(slaughter, stocker, feeder, and dairy and beef replacement heifers) at 
a rate of 50 to 200 milligrams per head per day. During the first 5 days 
of feeding, cattle should receive no more than 100 milligrams per day. 
Do not feed additional salt or minerals. Do not mix with 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. Do not feed to lactating dairy 
cattle. The product's effectiveness in cull cows and bulls has not been 
established. Consumption by unapproved species may result in toxic 
reactions. A feed manufacturing facility must possess a medicated feed 
mill license issued under Sec.  515.20 of this chapter in order to 
manufacture this free-choice Type C feed.
    (xi) Amount per ton. Monensin, 10 to 200 grams.
    (a) Indications for use. For prevention and control of coccidiosis 
due to E. bovis and E. zuernii.
    (b) Limitations. For calves excluding veal calves. Feed at a rate of 
0.14 to 1.0 milligram monensin per pound of body weight per day, 
depending upon the severity of challenge, up to maximum of 200 
milligrams per head per day.
    (xii) Amount per ton. Monensin, 10 to 30 grams; plus tylosin, 8 to 
10 grams.
    (a) Indications for use. For improved feed efficiency, prevention 
and control of coccidiosis due to Eimeria bovis and E. zuernii, and 
reduction of incidence of liver abscesses caused by Fusobacterium 
necrophorum and Actinomyces (Corynebacterium) pyogenes.
    (b) Limitations. Feed only to cattle being fed in confinement for 
slaughter. Feed continuously to provide 50 to 360 milligrams monensin 
per head per day. For prevention and control of coccidiosis, feed at a 
rate of 0.14 to 0.42 milligram monensin per pound of body weight per 
day, depending upon the severity of challenge, up to maximum of 360 
milligrams per head per day; and 60 to 90 milligram of tylosin per head 
per day.
    (4) Replacement chickens intended for use as cage layers--(i) Amount 
per ton. Monensin, 90 to 110 grams.
    (i)(a) Indications for use. As an aid in the prevention of 
coccidiosis caused by E. necatrix, E. tenella, E. acervulina, E. 
brunetti, E. mivati, and E. maxima.

[[Page 438]]

    (ii) Amount per ton. Monensin, 90 to 110 grams; plus bacitracin 
methylene disalicylate, 4 to 50 grams.
    (a) Indications for use. As an aid in the prevention of coccidiosis 
caused by E. necatrix, E. tenella, E. acervulina, E. brunetti, E. 
mivati, and E. maxima; for increased rate of weight gain, and improved 
feed efficiency.
    (b) Limitations. Feed continuously as sole ration. Do not feed to 
chickens over 16 weeks of age. Do not feed to laying chickens. As 
monensin sodium provided by 000986; bacitracin methylene disalicylate as 
provided by 046573 in Sec.  510.600(c) of this chapter.
    (iii) Amount per ton. Monensin, 90 to 110 grams; plus bacitracin 
methylene disalicylate, 50 grams.
    (a) Indications for use. As an aid in the prevention of coccidiosis 
caused by E. necatrix, E. tenella, E. acervulina, E. brunetti, E. 
mivati, and E. maxima; and as an aid in the prevention of necrotic 
enteritis caused or complicated by Clostridium spp. or other organisms 
susceptible to bacitracin.
    (b) Limitations. Feed continuously as sole ration. Do not feed to 
chickens over 16 weeks of age. Do not feed to laying chickens. As 
monensin sodium provided by 000986; bacitracin methylene disalicylate as 
provided by 046573 in Sec.  510.600(c) of this chapter.
    (iv) Limitations. Do not feed to laying chickens; feed continuously 
as sole ration; as monensin sodium; do not feed to chickens over 16 
weeks of age.
    (v) Amount per ton. Monensin, 90 to 110 grams; plus bacitracin 
methylene disalicylate, 100 to 200 grams.
    (a) Indications for use. As an aid in the prevention of coccidiosis 
caused by E. necatrix, E. tenella, E. acervulina, E. brunetti, E. 
mivati, and E. maxima; and as an aid in the control of necrotic 
enteritis caused or complicated by Clostridium spp. or other organisms 
susceptible to bacitracin.
    (b) Limitations. Feed continuously as sole ration. Do not feed to 
chickens over 16 weeks of age. Do not feed to laying chickens. To 
control necrotic enteritis, start medication at first clinical signs of 
disease; vary dosage based on the severity of infection; administer 
continuously for 5 to 7 days or as long as clinical signs persist, then 
reduce bacitracin to prevention level (50 grams per ton). As monensin 
sodium provided by 000986; bacitracin methylene disalicylate as provided 
by 046573 in Sec.  510.600(c) of this chapter.
    (vi) Amount per ton. Monensin, 90 to 110 grams; bacitracin methylene 
disalicylate, 50 grams; plus roxarsone, 22.7 to 45.4 grams.
    (a) Indications for use. As an aid in the prevention of coccidiosis 
caused by E. necatrix, E. tenella, E. acervulina, E. brunetti, E. 
mivati, and E. maxima; as an aid in the prevention of necrotic enteritis 
caused or complicated by Clostridium spp. or other organisms susceptible 
to bacitracin; and for increased rate of weight gain, improved feed 
efficiency, and improved pigmentation.
    (b) Limitations. Feed continuously as sole ration. Do not feed to 
laying chickens. Use as sole source of organic arsenic. Do not feed to 
chickens over 16 weeks of age. Poultry should have access to drinking 
water at all times. Drug overdosage or lack of water may result in leg 
weakness or paralysis. Withdraw 5 days before slaughter. As monensin 
sodium provided by 000986; bacitracin methylene disalicylate and 
roxarsone as provided by 046573 in Sec.  510.600(c) of this chapter.
    (vii) Amount per ton. Monensin, 90 to 110 grams; bacitracin 
methylene disalicylate, 100 to 200 grams; plus roxarsone, 22.7 to 45.4 
grams.
    (a) Indications for use. As an aid in the prevention of coccidiosis 
caused by E. necatrix, E. tenella, E. acervulina, E. brunetti, E. 
mivati, and E. maxima; as an aid in the control of necrotic enteritis 
caused or complicated by Clostridium spp. or other organisms susceptible 
to bacitracin; and for increased rate of weight gain, improved feed 
efficiency, and improved pigmentation.
    (b) Limitations. Feed continuously as sole ration. To control 
necrotic enteritis, start medication at first clinical signs of disease; 
vary bacitracin dosage based on the severity of infection; administer 
continuously for 5 to 7 days or as long as clinical signs persist, then 
reduce bacitracin to prevention level (50 grams/ton). Do not feed to 
laying chickens. Use as sole source of organic arsenic. Do not feed to 
chickens over 16 weeks of age. Poultry should have access to drinking 
water at all times. Drug overdosage or lack of water may

[[Page 439]]

result in leg weakness or paralysis. Withdraw 5 days before slaughter. 
As monensin sodium provided by 000986; bacitracin methylene disalicylate 
and roxarsone as provided by 046573 in Sec.  510.600(c) of this chapter.
    (iv) Amount per ton. Monensin, 90 to 110 grams, plus roxarsone, 22.7 
to 45.4 grams.
    (a) Indications for use. As an aid in the prevention of coccidiosis 
caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. 
mivati, and E. maxima, and for increased rate of weight gain, improved 
feed efficiency, and improved pigmentation.
    (b) Limitations. Feed continuously as sole ration. Use as sole 
source of organic arsenic. Withdraw 5 days before slaughter. Do not feed 
to laying chickens. Do not feed to chickens over 16 weeks of age. 
Poultry should have access to drinking water at all times. Drug 
overdosage or lack of water may result in leg weakness or paralysis. As 
monensin sodium provided by 000986; roxarsone as provided by 046573 in 
Sec.  510.600(c) of this chapter.
    (5) Bobwhite quail--(i) Amount per ton. Monensin, 73 grams.
    (ii) Indications for use. For the prevention of coccidiosis in 
growing bobwhite quail caused by Eimeria dispersa and E. Lettyae.
    (iii) Limitations. Feed continuously as the sole ration; do not 
allow horses, other equines, mature turkeys, or guinea fowl access to 
feed containing monensin.
    (6) Goats--(i) Amount per ton. Monensin, 20 grams.
    (a) Indications for use. For the prevention of coccidiosis caused by 
Eimeria crandallis, E. christenseni, and E. ninakohlyakimovae.
    (b) Limitations. (1) Feed only to goats being fed in confinement. Do 
not feed to lactating goats. Feed continuously in Type C feed as 
monensin sodium. Type C feeds may be manufactured from monensin liquid 
Type B feeds. The liquid Type B feeds have a pH of 4.3 to 7.1 and their 
labels must bear appropriate mixing directions. Mixing directions for 
liquid Type B feeds stored in recirculating tank systems are: 
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 directed in this 
paragraph, even when Type B feed is not used. Mixing directions for 
liquid Type B feeds stored in mechanical, air, or other agitation-type 
tank systems are: 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 directed in this paragraph, even when Type 
B feed is not used. The liquid Type B feed must bear directions to mix 
thoroughly with grain and/or roughage prior to feeding and must bear 
caution statement as follows: Inadequate mixing (recirculation or 
agitation), of liquid Type B feeds has resulted in increased monensin 
concentration which could be fatal to goats.
    (2) An approved positionally stable monensin liquid Type B feed will 
not be subject to the requirements for mixing directions and cautionary 
labeling prescribed in paragraph (f)(6)(i)(b)(1) of this section. A 
manufacturer may secure approval of a positionally stable liquid Type B 
feed by (i) either filing an NADA for the product or by 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 NADA to establish 
positional stability; and (iii) requesting No. 000986 in Sec.  
510.600(c) of this chapter to file a supplemental NADA to provide for 
the use of its monensin Type A article in the manufacture of the liquid 
Type B feed specified in the appropriate master file. If the data 
demonstrate the stability of the liquid Type B feed described in the 
master file, the agency will approve the supplemental NADA. Approval of 
the Type B feed need not be published in the Federal Register because 
approval will not affect or alter the content of the regulation. The 
approval will, however, provide a basis for the individual liquid feed 
manufacturer to submit, and for the agency to approve, a medicated feed 
application under section 512(m) of the act for the liquid Type B feed. 
A manufacturer who seeks to market a positionally unstable monensin 
liquid Type B feed with mixing directions different from

[[Page 440]]

the standard established in paragraph (f)(6)(i)(b)(1) of this section 
may also follow this procedure.
    (ii) [Reserved]
    (7) Monensin may also be used in combination with:
    (i) Decoquinate alone or with tylosin as in Sec.  558.195.
    (ii) Melengestrol acetate alone or with tylosin as in Sec.  558.342.

[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 on GPO Access.



Sec.  558.360  Morantel tartrate.

    (a) Approvals. Type A medicated articles: 88 grams per pound to 
066104 in Sec.  510.600(c) of this chapter.
    (b) Related tolerances. See Sec.  556.425 of this chapter.
    (c) 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.
    (d) Conditions of use--(1) Amount. 0.44 to 4.4 grams of morantel 
tartrate per pound of feed.
    (2) Indications for use--(i) Cattle. 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).
    (ii) Goats. For removal and control of mature gastrointestinal 
nematode infections of goats including Haemonchus contortus, Ostertagia 
(Teladorsagia) circumcincta, and Trichostrongylus axei.
    (3) Limitations. Feed as a single therapeutic treatment at 0.44 gram 
of morantel tartrate per 100 pounds of body weight. Fresh water should 
be available at all times. When medicated feed is consumed, resume 
normal feeding. Conditions of constant worm exposure may require 
retreatment in 2 to 4 weeks. Do not treat cattle within 14 days of 
slaughter; do not treat goats within 30 days of slaughter.

[46 FR 50950, Oct. 16, 1981, as amended at 47 FR 53352, Nov. 26, 1982; 
51 FR 7399, Mar. 3, 1986; 51 FR 9005, Mar. 17, 1986; 52 FR 11642, Apr. 
10, 1987; 59 FR 17922, Apr. 15, 1994; 66 FR 47963, Sept. 17, 2001]



Sec.  558.363  Narasin.

    (a) Approvals. Type A medicated articles containing specified levels 
of narasin approved for sponsors identified in Sec.  510.600(c) of this 
chapter for use as in paragraph (d) of this section are as follows:
    (1) To 000986: 36, 45, 54, 72, and 90 grams per pound, paragraph 
(d)(1)(i) of this section.
    (2) To 000986: 36, 45, 54, 72, and 90 grams per pound, with 10, 20, 
50, and 80 percent roxarsone, paragraph (d)(1)(ii) of this section.
    (3) To 000986: 36 grams per pound, with 36 grams per pound 
nicarbazin, paragraph (d)(1)(iii) of this section.
    (4) To 057926: 36, 45, 54, 72, and 90 grams per pound, with 2 and 10 
grams per pound bambermycins, paragraph (d)(1)(iv) of this section.
    (5) To 057926: 45 grams per pound, with 4 and 10 grams per pound 
bambermycins, and 45.4, 90, and 227 grams per pound roxarsone, paragraph 
(d)(1)(vii) of this section.
    (6) To 046573: 45 grams per pound with 10, 25, 30, 40, 50, 60, or 75 
grams per pound bacitracin methylene disalicylate and 45.4, 90, or 227 
grams per pound roxarsone, paragraphs (d)(1)(viii) and (d)(1)(ix) of 
this section.
    (7) To 046573: 36, 45, 54, 72, or 90 grams per pound, with 10, 25, 
40, or 50 grams per pound bacitracin zinc, paragraph (d)(1)(x) of this 
section.
    (b) Tolerances. See Sec.  556.428 of this chapter.
    (c) [Reserved]
    (d) Conditions of use. It is used as follows:
    (1) Broiler chickens--(i) Amount per ton. Narasin, 54 to 72 grams.
    (A) Indications for use. For prevention of coccidiosis caused by 
Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and 
E. maxima.
    (B) Limitations. For broiler chickens only. Feed continuously as 
sole ration. Do not allow adult turkeys, horses, or

[[Page 441]]

other equines access to narasin formulations. Ingestion of narasin by 
these species has been fatal.
    (ii) Amount per ton. Narasin, 54 to 72 grams, plus roxarsone 45.4 
grams (0.005 percent).
    (A) Indications for use. For the prevention of coccidiosis in 
broiler chickens caused by Eimeria tenella, E. necatrix, E. acervulina, 
E. maxima, E. brunetti, and E. mivati including some field strains of E. 
tenella which are more susceptible to roxarsone combined with narasin 
than to narasin alone.
    (B) Limitations. For broiler chickens only; feed continuously as the 
sole ration; do not feed to laying chickens; may be fatal if 
accidentally fed to adult turkeys or to horses; withdraw 5 days before 
slaughter; as sole source of organic arsenic; not approved for use with 
pellet binders.
    (iii) Amount per ton. Narasin, 27 to 45 grams, plus nicarbazin, 27 
to 45 grams.
    (A) Indications for use. For the prevention of coccidiosis caused by 
Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and 
E. maxima.
    (B) Limitations. For broiler chickens only. Feed continuously as the 
sole ration. Do not feed to laying hens. Do not allow adult turkeys, 
horses, or other equines access to formulations containing narasin. 
Ingestion of narasin by these animals has been fatal. Withdraw 5 days 
before slaughter. The 2 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. 000986 in Sec.  510.600(c) of this chapter may be used in the 
combination.
    (iv) Amount per ton. Narasin, 54 to 72 grams, plus bambermycins, 1 
to 2 grams.
    (A) Indications for use. For prevention of coccidiosis caused by 
Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and 
E. maxima, and for increased rate of weight gain and improved feed 
efficiency.
    (B) Limitations. For broiler chickens only. Feed continuously as the 
sole ration. May be fatal if fed to adult turkeys, horses, or other 
equines.
    (v) Amount per ton. Narasin 54 to 72 grams, roxarsone 22.7 to 45.4 
grams, and bacitracin methylene disalicylate 10 to 50 grams.
    (A) Indications for use. For prevention of coccidiosis caused by 
Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and 
E. mivati, for increased rate of weight gain, and for improved feed 
efficiency.
    (B) Limitations. For broiler chickens only. Feed continuously as 
sole ration. Withdraw 5 days before slaughter. Do not feed to laying 
hens. Use as sole source of organic arsenic. Drug overdose or lack of 
water may result in leg weakness. 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 000986, roxarsone 
by 046573, bacitracin methylene disalicylate by 046573 in Sec.  
510.600(c) of this chapter.
    (vi) Amount per ton. Narasin 54 to 72 grams, and bacitracin 
methylene disalicylate 10 to 50 grams.
    (A) Indications for use. For the prevention of coccidiosis caused by 
Eimeria acervulina, E. brunetti, E. maxima, E. mivati, E. necatrix, and 
E. tenella, for increased rate of weight gain, and for improved feed 
efficiency.
    (B) Limitations. For broiler chickens only. Feed continuously as 
sole ration. Do not feed to laying hens. 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 000986, 
bacitracin methylene disalicylate by 046573 in Sec.  510.600(c) of this 
chapter.
    (vii) Amount per ton. Narasin 54 to 72 grams, bambermycins 1 to 2 
grams, and roxarsone 22.7 to 45.4 grams.
    (A) Indications for use. For prevention of coccidiosis caused by 
Eimeria tenella, E. necatrix, E. mivati, E. acervulina, E. maxima, and 
E. brunetti, and for increased rate of weight gain, improved feed 
efficiency, and improved pigmentation in broiler chickens.
    (B) Limitations. For broiler chickens only. Feed continuously as 
sole ration. Do not feed to laying hens. Do not allow adult turkeys or 
horses or other equines access to formulations containing narasin. 
Ingestion of narasin by these animals has been fatal. Use as sole source 
of organic arsenic. Poultry

[[Page 442]]

should have access to drinking water at all times. Drug overdosage or 
lack of water intake may result in leg weakness or paralysis. Withdraw 5 
days before slaughter. Narasin as provided by 000986 in Sec.  510.600(c) 
of this chapter, bambermycins by 057926, and roxarsone by 046573.
    (viii) Amount per ton. Narasin, 54 to 72 grams, and bacitracin 
methylene disalicylate, 50 grams, with roxarsone, 22.7 to 45.4 grams.
    (A) Indications for use. For prevention of coccidiosis caused by 
Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and 
E. maxima, as an aid in the prevention of necrotic enteritis caused or 
complicated by Clostridium spp. or other organisms susceptible to 
bacitracin, and for increased rate of weight gain, improved feed 
efficiency, and improved pigmentation.
    (B) Limitations. For broiler chickens only. Feed continuously as 
sole ration. Withdraw 5 days before slaughter. Do not feed to laying 
hens. Do not allow adult turkeys, horses, or other equines access to 
narasin formulations. Ingestion of narasin by these species has been 
fatal. Use as sole source of organic arsenic. Poultry should have access 
to drinking water at all times. Drug overdose or lack of water intake 
may result in leg weakness or paralysis. Narasin as provided by 000986, 
bacitracin methylene disalicylate and roxarsone by 046573 in Sec.  
510.600(c) of this chapter.
    (ix) Amount per ton. Narasin, 54 to 72 grams, and bacitracin 
methylene disalicylate, 100 to 200 grams, with roxarsone, 22.7 to 45.4 
grams.
    (A) Indications for use. For prevention of coccidiosis caused by 
Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and 
E. maxima, as an aid in the control of necrotic enteritis caused or 
complicated by Clostridium spp. or other organisms susceptible to 
bacitracin, and for increased rate of weight gain, improved feed 
efficiency, and improved pigmentation.
    (B) Limitations. For broiler chickens only. Feed continuously as 
sole ration. Withdraw 5 days before slaughter. Do not feed to laying 
hens. Do not allow adult turkeys, horses, or other equines access to 
narasin formulations. Ingestion of narasin by these species has been 
fatal. Use as sole source of organic arsenic. Poultry should have access 
to drinking water at all times. Drug overdose or lack of water intake 
may result in leg weakness or paralysis. Narasin as provided by 000986, 
bacitracin methylene disalicylate and roxarsone by 046573 in Sec.  
510.600(c) of this chapter.
    (x) Amount per ton. Narasin, 54 to 72 grams and bacitracin zinc, 4 
to 50 grams.
    (A) Indications for use. For the prevention of coccidiosis caused by 
Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and 
E. maxima, and for increased rate of weight gain and improved feed 
efficiency.
    (B) Limitations. For broiler chickens only. Feed continuously as 
sole ration. Do not allow adult turkeys, horses, or other equines access 
to formulations containing narasin. Ingestion of narasin by these 
species has been fatal. Narasin as provided by 000986, bacitracin zinc 
by 046573 in Sec.  510.600(c) of this chapter.
    (xi) Amount per ton. Narasin, 54 to 72 grams, plus tylosin, 4 to 50 
grams.
    (A) Indications for use. As an aid in the prevention of coccidiosis 
caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. 
mivati, and E. maxima, for increased rate of weight gain, and improved 
feed efficiency.
    (B) Limitations. For broiler chickens only. Feed continuously as 
sole ration. Do not allow adult turkeys, horses, or other equines access 
to formulations containing narasin. Ingestion of narasin by these 
species has been fatal. Narasin sodium and tylosin phosphate as provided 
by 000986 in Sec.  510.600(c) of this chapter.
    (xii) Amount per ton. Narasin, 27 to 45 grams; nicarbazin, 27 to 45 
grams; and bambermycins, 1 to 2 grams.
    (A) Indications for use. For the prevention of coccidiosis caused by 
Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and 
E. mivati, and for increased rate of weight gain and improved feed 
efficiency.
    (B) Limitations. Feed continuously as the sole ration. Do not allow 
adult turkeys, horses, or other equines access to formulations 
containing narasin. Ingestion of narasin by these animals has been 
fatal. Do not feed to laying hens.

[[Page 443]]

Withdraw 5 days before slaughter. Narasin and nicarbazin as provided by 
000986, bambermycins by 057926 in Sec.  510.600(c) of this chapter.
    (2) Narasin may also be used for broilers in combination with:
    (i) Nicarbazin with lincomycin as in Sec.  558.366.
    (ii) Nicarbazin and bacitracin methylene disalicylate as in Sec.  
558.366.
    (iii) Bacitracin methylene disalicylate, nicarbazin, and roxarsone 
as in Sec.  558.366.
    (iv) Nicarbazin and roxarsone as in Sec.  558.366.

[51 FR 29098, Aug. 14, 1986

    Editorial Note: For Federal Register citations affecting Sec.  
558.363, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and on GPO Access.



Sec.  558.364  Neomycin sulfate.

    (a) Approvals. Type A medicated article: 325 grams per pound to 
000009 in Sec.  510.600(c) of this chapter.
    (b) Related tolerances. See Sec.  556.430 of this chapter.
    (c) [Reserved]
    (d) Conditions of use. Neomycin sulfate is used as follows:

[[Page 444]]



 
----------------------------------------------------------------------------------------------------------------
   Neomycin Sulfate         Combination        Indications for Use        Limitations              Sponsor
----------------------------------------------------------------------------------------------------------------
(1) 250 to 2,250       .....................  Cattle, swine, sheep,  To provide 10          000009
 grams per ton (g/t)                           and goats. For         milligrams (mg) of
 of dry type C feed.                           treatment and          neomycin sulfate per
                                               control of             pound of body weight
                                               colibacillosis         per day for a
                                               (bacterial             maximum of 14 days.
                                               enteritis) caused by   The concentration of
                                               Escherichia coli       neomycin sulfate
                                               susceptible to         required in
                                               neomycin.              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 445]]

 
(2) 400 to 2,000 g/t   .....................  Do.                    To provide 10 mg of    000009
 of type C milk                                                       neomycin sulfate per
 replacer.                                                            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]



Sec.  558.365  Nequinate.

    (a) Approvals. Type A medicated articles: 4 percent to 017800 in 
Sec.  510.600(c) of this chapter.
    (b) Related tolerances. See Sec.  556.440 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 as follows:
    (1) Broiler or fryer chickens--(i) Amount per ton. Nequinate, 18.16 
grams.
    (ii) Indications for use. An aid in the prevention of coccidiosis 
caused by E. tenella, E. necatrix, E. acervulina, E. maxima, E. 
brunetti, and E. mivati.
    (iii) Limitations. Feed continuously as the sole ration.
    (2) Roaster chickens or replacement chickens for caged layers--(i) 
Amount per ton. Nequinate, 18.16 grams (0.002 percent).
    (ii) Indications for use. An aid in the prevention of coccidiosis 
caused by E. tenella, E. necatrix, E. acervulina, E. maxima, E. 
brunetti, and E. mivati.
    (iii) Limitations. Feed continuously as the sole ration; do not feed 
to chickens over 16 weeks of age.

[40 FR 13959, Mar. 27, 1975, as amended at 51 FR 7399, Mar. 3, 1986; 52 
FR 2685, Jan. 26, 1987; 66 FR 45167, Aug. 28, 2001]



Sec.  558.366  Nicarbazin.

    (a) Specifications. Type A medicated articles containing 25 percent 
nicarbazin.

[[Page 446]]

    (b) Approvals. See Nos. 000986, 060728, and 066104 in Sec.  
510.600(c) of this chapter for use as in paragraph (d) of this section.
    (c) Related tolerances. See Sec.  556.445 of this chapter.
    (d) Conditons of use. It is used in chicken feed as follows:

----------------------------------------------------------------------------------------------------------------
                                Combination in grams
 Nicarbazin in grams per ton          per ton            Indications for use         Limitations        Sponsor
----------------------------------------------------------------------------------------------------------------
27 to 45....................  Narasin 27 to 45.......  Broiler chickens;       Sec.                       000986
                                                        prevention of           558.363(d)(1)(iii).
                                                        coccidiosis caused by
                                                        Eimeria tenella, E.
                                                        necatrix, E.
                                                        acervulina, E.
                                                        maxima, E. brunetti,
                                                        E. mivati..
                              Narasin 27 to 45 and     Broiler chickens;       Feed continuously as       000986
                               bacitracin methylene     prevention of           sole ration. Withdraw
                               disalicylate 4 to 50.    coccidiosis caused by   5 days before
                                                        Eimeria tenella, E.     slaughter. Do not
                                                        necatrix, E.            allow turkeys,
                                                        acervulina, E.          horses, or other
                                                        maxima, E. brunetti,    equines access to
                                                        E. mivati; for          formulations
                                                        increased rate of       containing narasin.
                                                        weight gain and         Ingestion of narasin
                                                        improved feed           by these species has
                                                        efficiency.             been fatal. Do not
                                                                                feed to laying hens.
                                                                                Narasin and
                                                                                nicarbazin as
                                                                                provided by 000986,
                                                                                bacitracin methylene
                                                                                disalicylate by
                                                                                046573.
                              Narasin 27 to 45 and     Broiler chickens: For   Feed continuously as       046573
                               bacitracin methylene     prevention of           sole ration. Do not
                               disalicylate 50..        coccidiosis caused by   feed to laying hens.
                                                        Eimeria tenella, E.     Withdraw 5 days
                                                        necatrix, E.            before slaughter. Do
                                                        acervulina, E.          not allow turkeys,
                                                        maxima, E. brunetti,    horses or other
                                                        and E. mivati; as an    equines access to
                                                        aid in the prevention   formulations
                                                        of necrotic enteritis   containing narasin.
                                                        caused or complicated   Ingestion of narasin
                                                        by Clostridium spp.     by these species has
                                                        or other organisms      been fatal. Narasin
                                                        susceptible to          and nicarbazin as
                                                        bacitracin..            provided by No.
                                                                                000986, bacitracin
                                                                                methylene
                                                                                disalicylate by No.
                                                                                046573 in Sec.
                                                                                510.600(c) of this
                                                                                chapter..
                              Narasin 27 to 45 and     Broiler chickens: For   To control necrotic        046573
                               bacitracin methylene     prevention of           enteritis, start
                               disalicylate 100 to      coccidiosis caused by   medication at first
                               200..                    Eimeria tenella, E.     clinical signs of
                                                        necatrix, E.            disease; vary dosage
                                                        acervulina, E.          based on the severity
                                                        maxima, E. brunetti,    of infection;
                                                        and E. mivati; as an    administer
                                                        aid in the control of   continuously for 5 to
                                                        necrotic enteritis      7 days or as long as
                                                        caused or complicated   clinical signs
                                                        by Clostridium spp.     persist, then reduce
                                                        or other organisms      bacitracin to
                                                        susceptible to          prevention level (50
                                                        bacitracin..            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. Narasin
                                                                                and nicarbazin as
                                                                                provided by No.
                                                                                000986, bacitracin
                                                                                methylene
                                                                                disalicylate by No.
                                                                                046573 in Sec.
                                                                                510.600(c) of this
                                                                                chapter..
                              Narasin 27 to 45,        Broiler chickens;       Feed continuously as       046573
                               bacitracin methylene     prevention of           sole ration. Withdraw
                               disalicylate 50, and     coccidiosis caused by   5 days before
                               roxarsone 22.7 to        Eimeria tenella, E.     slaughter. Do not
                               45.4..                   necatrix, E.            allow turkeys, horses
                                                        acervulina, E.          or other equines
                                                        maxima, E. brunetti,    access to
                                                        and E. mivati, as an    formulations
                                                        aid in the prevention   containing narasin.
                                                        of necrotic enteritis   Ingestion of narasin
                                                        caused or complicated   by these species has
                                                        by Clostridium spp.     been fatal. Do not
                                                        or other organisms      feed to laying hens.
                                                        susceptible to          Use as sole source of
                                                        bacitracin, for         organic arsenic.
                                                        increased rate of       Narasin and
                                                        weight gain, improved   nicarbazin as
                                                        feed efficiency, and    provided by 000986,
                                                        improved                bacitracin methylene
                                                        pigmentation..          disalicylate and
                                                                                roxarsone by 046573..

[[Page 447]]

 
                              Narasin 27 to 45 and     Broiler chickens;       Feed continuously as       000986
                               Lincomycin 2 to 4.       prevention of           sole ration. Withdraw
                                                        coccidiosis caused by   5 days before
                                                        Eimeria tenella, E.     slaughter. Do not
                                                        necatrix, E.            allow turkeys,
                                                        acervulina, E.          horses, or other
                                                        maxima, E. brunetti,    equines access to
                                                        E. mivati; for          formulations
                                                        increased rate of       containing narasin.
                                                        weight gain and         Ingestion of narasin
                                                        improved feed           by these species has
                                                        efficiency.             been fatal. Do not
                                                                                feed to laying hens.
                                                                                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. Narasin and
                                                                                nicarbazin as
                                                                                provided by 000986,
                                                                                lincomycin by 000009.
                              Narasin 27 to 45 and     Broiler chickens; for   Feed continuously as       000986
                               roxarsone 22.7 to        prevention of           sole ration. Use as
                               45.4..                   coccidiosis caused by   sole source of
                                                        Eimeria tenella, E.     organic arsenic.
                                                        necatrix, E.            Withdraw 5 days
                                                        acervulina, E.          before slaughter. Do
                                                        maxima, E. brunetti,    not allow turkeys,
                                                        and E. mivati; for      horses or other
                                                        increased rate of       equines access to
                                                        weight gain, improved   formulations
                                                        feed efficiency, and    containing narasin.
                                                        improved                Ingestion of narasin
                                                        pigmentation..          by these species has
                                                                                been fatal. Do not
                                                                                feed to laying hens.
                                                                                Use as sole source of
                                                                                organic arsenic.
                                                                                Narasin and
                                                                                nicarbazin as
                                                                                provided by 000986,
                                                                                roxarsone by 046573..
113.5 (0.0125 pct)..........  .......................  Chickens; aid in        Feed continuously as       000986
                                                        preventing outbreaks    sole ration from time     060728
                                                        of cecal (Eimeria       chicks are placed on      066104
                                                        tenella) and            litter until past the
                                                        intestinal (E.          time when coccidiosis
                                                        acervulina, E.          is ordinarily a
                                                        maxima, E. necatrix,    hazard; do not use as
                                                        and E. brunetti)        a treatment for
                                                        coccidiosis.            coccidiosis; do not
                                                                                use in flushing
                                                                                mashes; do not feed
                                                                                to laying hens;
                                                                                withdraw 4 days
                                                                                before slaughter.
                              Bacitracin methylene     Broiler chickens; aid   ......do..............     060728
                               disalicylate 30.         in preventing                                     066104
                                                        outbreaks of cecal
                                                        (Eimeria tenella) and
                                                        intestinal (E.
                                                        acervulina, E.
                                                        maxima, E. necatrix,
                                                        and E. brunetti)
                                                        coccidiosis; for
                                                        increased rate of
                                                        weight gain and
                                                        improved feed
                                                        efficiency.
                              Bacitracin zinc 4 to     Broiler chickens; aid   For broiler chickens       066104
                               50..                     in preventing           only. Feed
                                                        outbreaks of cecal      continuously as sole
                                                        (Eimeria tenella) and   ration from time
                                                        intestinal (E.          chicks are placed on
                                                        acervulina, E.          litter until past the
                                                        maxima, E. necatrix,    time when coccidiosis
                                                        and E. brunetti)        is ordinarily a
                                                        coccidiosis, and for    hazard. Discontinue
                                                        increased rate of       medication 4 days
                                                        weight gain and         before marketing the
                                                        improved feed           birds for human
                                                        efficiency..            consumption to allow
                                                                                for elimination of
                                                                                the drug from edible
                                                                                tissue. Do not feed
                                                                                to laying hens in
                                                                                production.
                                                                                Nicarbazin as
                                                                                provided by 066104,
                                                                                bacitracin zinc by
                                                                                046573..

[[Page 448]]

 
                              Bambermycins 1 to 2....  Broiler chickens; aid   Feed continuously as       057926
                                                        in preventing           sole ration from time
                                                        outbreaks of cecal      chicks are placed on
                                                        (Eimeria tenella) and   litter until past the
                                                        intestinal (E.          time when coccidiosis
                                                        acervulina, E.          is ordinarily a
                                                        maxima, E. necatrix,    hazard; do not use as
                                                        and E. brunetti)        a treatment for
                                                        coccidiosis, for        coccidiosis; do not
                                                        increased rate of       use in flushing
                                                        weight gain and         mashes; do not feed
                                                        improved feed           to laying hens;
                                                        efficiency..            withdraw 4 days
                                                                                before slaughter.
                                                                                Nicarbazin as
                                                                                provided by 066104..
                              Lincomycin 2 (0.00044    Broiler chickens; aid   Feed continuously as       060728
                               pct).                    in preventing           sole ration from time     066104
                                                        outbreaks of secal      chicks are placed on
                                                        (Eimeria tenella) and   litter until past the
                                                        intestinal (E.          time when coccidiosis
                                                        acervulina, E.          is ordinarily a
                                                        maxima, E. necatrix,    hazard; do not use as
                                                        and E. brunetti)        a treatment for
                                                        coccidiosis; for        coccidiosis; do not
                                                        increased rate of       use in flushing
                                                        weight gain..           mashes; do not feed
                                                                                to laying hens;
                                                                                withdraw 4 days
                                                                                before slaughter..
                              Roxarsone 22.7           ......do..............  Feed continuously as       060728
                               (0.0025)..                                       sole ration from time     066104
                                                                                chicks are placed on
                                                                                litter until past the
                                                                                time when coccidiosis
                                                                                is ordinarily a
                                                                                hazard; as sole
                                                                                source of organic
                                                                                arsenic; do not use a
                                                                                treatment for
                                                                                coccidiosis; do not
                                                                                use in flushing
                                                                                mashes; do not feed
                                                                                to laying hens;
                                                                                withdraw 5 days
                                                                                before slaughter.
                              Roxarsone 22.7 (0.0025)  ......do..............  ......do..............     060728
                               plus lincomycin 2                                                          066104
                               (0.0004)..
----------------------------------------------------------------------------------------------------------------


[42 FR 56729, Oct. 28, 1977; 43 FR 1942, Jan. 13, 1978, as amended at 44 
FR 40887, July 13, 1979; 50 FR 13562, Apr. 5, 1985; 51 FR 7399, Mar. 3, 
1986; 54 FR 1928, Jan. 18, 1989; 60 FR 29483, June 5, 1995; 61 FR 1832, 
Jan. 24, 1996; 61 FR 14021, Mar. 29, 1996; 61 FR 14483, Apr. 2, 1996; 62 
FR 29011, May 29, 1997; 63 FR 13124, Mar. 18, 1998; 63 FR 57248, Oct. 
27, 1998; 64 FR 4966, Feb. 2, 1999; 64 FR 18574, Apr. 15, 1999; 64 FR 
20164, Apr. 26, 1999; 64 FR 49384, Sept. 13, 1999; 65 FR 11889, Mar. 7, 
2000; 66 FR 46706, Sept. 7, 2001; 66 FR 47962, Sept. 17, 2001; 66 FR 
63500, Dec. 7, 2001; 67 FR 30327, May 6, 2002]



Sec.  558.369  Nitarsone.

    (a) Approvals. Type A medicated articles: 50 percent to 046573 in 
Sec.  510.600(c) of this chapter.
    (b) Related tolerances. See Sec.  556.60 of this chapter.
    (c) [Reserved]
    (d) Conditions of use. It is used as follows:
    (1) Chickens and turkeys.--(i) Amount. Nitarsone, 0.01875 percent.
    (ii) Indications for use. As an aid in the prevention of blackhead.
    (iii) Limitations. Early medication is essential to prevent spread 
of disease. Adequate drinking water must be provided near feeder at all 
times. The drug is not effective in preventing blackhead in birds 
infected more than 4 or 5 days. Discontinue use 5 days before 
slaughtering animals for human consumption to allow elimination of the 
drug from edible tissues. The drug is dangerous for ducks, geese, and 
dogs. Overdosage or lack of water may result in leg weakness or 
paralysis. Use as sole source of arsenic.
    (2) Turkeys--(i) Amount. Nitarsone 0.01875 percent, plus bacitracin 
methylene disalicylate 4 to 50 grams per ton.
    (ii) Indications for use. As an aid in the prevention of blackhead, 
and for increased rate of weight gain and improved feed efficiency.
    (iii) Limitations. For growing turkeys. Feed continuously as sole 
ration. Early medication is essential to prevent spread of disease. 
Adequate drinking water must be provided near feeders at

[[Page 449]]

all times. Overdosage or lack of water may result in leg weakness or 
paralysis. The drug is not effective in preventing blackhead in birds 
infected more than 4 or 5 days. Discontinue use 5 days before 
slaughtering animals for human consumption to allow elimination of the 
drug from edible tissues. The drug is dangerous for ducks, geese, and 
dogs. Use as sole source of arsenic.

[46 FR 47535, Sept. 29, 1981, as amended at 47 FR 14152, Apr. 2, 1982; 
51 FR 7399, Mar. 3, 1986; 52 FR 2686, Jan. 26, 1987; 55 FR 8460, Mar. 8, 
1990; 57 FR 8578, Mar. 11, 1992; 63 FR 39028, July 21, 1998]



Sec.  558.376  Nitromide and sulfanitran.

    (a) Approvals. Type A medicated articles: 25 percent nitromide, 30 
percent sulfanitran, with or without 5 percent roxarsone to 053501 in 
Sec.  510.600(c) of this chapter.
    (b) Related tolerances. See Sec. Sec.  556.220 and 556.680 of this 
chapter.
    (c) Conditions of use. It is used for chickens as follows:
    (1) Amount. 227 grams per ton nitromide (0.025 percent) and 272 
grams per ton sulfanitran (0.03 percent).
    (i) Indications for use. As an aid in the prevention of coccidiosis 
caused by Eimeria tenella, E. necatrix, and E. acervulina.
    (ii) Limitations. Not to be fed to laying chickens; withdraw 5 days 
before slaughter; from Type A articles containing not more than 25 
percent nitromide and 30 percent sulfanitran.
    (2) Amount. 227 grams per ton nitromide (0.025 percent) and 272 
grams per ton sulfanitran (0.03 percent), plus 45.4 grams per ton 
roxarsone (0.005 percent).
    (i) Indications for use. Prevention of coccidiosis caused by Eimeria 
tenella, E. necatrix, and E. acervulina; growth promotion and feed 
efficiency; improving pigmentation.
    (ii) Limitations. Not to be fed to laying chickens; withdraw 5 days 
before slaughter; from Type A articles containing not more than 25 
percent nitromide, 30 per cent sulfanitan, and 5 percent roxarsone; as 
sole source of organic arsenic.

[41 FR 11002, Mar. 15, 1976, as amended at 51 FR 7399, Mar. 3, 1986; 52 
FR 2686, Jan. 26, 1987; 55 FR 8460, Mar. 8, 1990]



Sec.  558.415  Novobiocin.

    (a) Approvals. Type A medicated articles: 25 grams of activity per 
pound to 000009 in Sec.  510.600(c) of this chapter. Type B medicated 
feeds: 17.5 grams per pound to 000009 in Sec.  510.600(c) of this 
chapter.
    (b) Related tolerances. See Sec.  556.460 of this chapter.
    (c) Conditions of use. It is used in animal feeds as follows:
    (1) Chickens--(i) Amount. Novobiocin, 6-7 mgs. per lb. body weight 
per day.
    (a) Indications for use. Aid in the treatment of breast blisters 
associated with staphylococcal infections susceptible to novobiocin.
    (b) Limitations. Administer, as sole ration, feed which contains not 
less than 200 grams of novobiocin activity per ton of feed; not for 
laying chickens; feed 5 to 7 days; withdraw 4 days before slaughter.
    (ii) Amount. Novobiocin, 10-14 mgs. per lb. body weight per day.
    (a) Indications for use. Treatment of staphylococcal synovitis and 
generalized staphylococcal infections susceptible to novobiocin.
    (b) Limitations. Administer, as sole ration, feed which contains not 
less than 350 grams of novobiocin activity per ton of feed; not for 
laying chickens; feed 5 to 7 days; withdraw 4 days before slaughter.
    (2) Turkeys--(i) Amount. Novobiocin, 4-5 mgs. per lb. body weight 
per day.
    (a) Indications for use. Aid in the treatment of breast blisters 
associated with staphylococcal infections susceptible to novobiocin.
    (b) Limitations. Administer, as sole ration, feed which contains not 
less than 200 grams of novobiocin activity per ton of feed; not for 
laying turkeys; feed 5 to 7 days; withdraw 4 days before slaughter.
    (ii) Amount. Novobiocin, 5-8 mgs. per lb. body weight per day.
    (a) Indications for use. Aid in the control of recurring outbreaks 
of fowl cholera caused by strains of Pasteurella multocida susceptible 
to novobiocin following initial treatment with 7-8 mgs. per pound body 
weight per day.
    (b) Limitations. Administer, as sole ration, feed which contains not 
less than 200 grams of novobiocin activity per

[[Page 450]]

ton of feed; feed 5 to 7 days; not for laying turkeys; withdraw 4 days 
before slaughter.
    (iii) Amount. Novobiocin, 7-8 mgs. per lb. body weight per day.
    (a) Indications for use. Treatment of staphylococcal synovitis and 
generalized staphylococcal infection susceptible to novobiocin; 
treatment of acute outbreaks of fowl cholera caused by strains of 
Pasteurella multocida susceptible to novobiocin.
    (b) Limitations. Administer, as sole ration, feed which contains not 
less than 350 grams of novobiocin activity per ton of feed; feed 5 to 7 
days; not for laying turkeys; withdraw 4 days before slaughter.
    (3) Mink--(i) Amount. 20 mgs. per lb. body weight per day.
    (ii) Indications for use. For treatment of generalized infections, 
abscesses, or urinary infections caused by staphylococcal or other 
novobiocin sensitive organisms.
    (iii) Limitations. Administer, as sole ration, feed which contains 
not less than 200 grams of novobiocin activity per ton of feed; feed for 
7 days.
    (4) Ducks--(i) Amount. Novobiocin, 350 grams per ton.
    (ii) Indications for use. Control of infectious serositis and fowl 
cholera in ducks caused by Pasteurella anatipestifer and P. multocida, 
susceptible to novobiocin.
    (iii) Limitations. Administer, as sole ration, for 5 to 7 days, 
continue medication for 14 days if necessary, repeat if reinfection 
occurs; discontinue use at least 3 days before slaughter; not for use in 
laying ducks.

[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]



Sec.  558.430  Nystatin.

    (a) Approvals. Type A medicated articles: 20 grams of activity per 
pound to 046573 in Sec.  510.600(c) of this chapter.
    (b) Related tolerances. See Sec.  556.470 of this chapter.
    (c) Conditions of use. It is used for chickens and turkeys as 
follows:
    (1) Amount. 50 grams per ton.
    (i) Indications for use. Chickens and turkeys; aid in control of 
crop mycosis and mycotic diarrhea (Candida albicans).
    (ii) Limitations. Growing and laying chickens; growing turkeys.
    (2) Amount. 100 grams per ton.
    (i) Indications for use. Chickens and turkeys; treatment of crop 
mycosis and mycotic diarrhea (Candida albicans).
    (ii) Limitations. Growing and laying chickens; growing turkeys; to 
be fed for 7 to 10 days.

[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]



Sec.  558.435  Oleandomycin.

    (a) Approvals. Type A medicated articles: 5 grams of activity per 
pound to 066104 in Sec.  510.600(c) of this chapter.
    (b) Related tolerances. See Sec.  556.480 of this chapter.
    (c) Special considerations. Do not use bentonite in Type B or Type C 
medicated feeds containing oleandomycin. Oleandomycin refers to 
oleandomycin or feed-grade oleandomycin.
    (d) Conditions of use. It is used in animal feed as follows:
    (1) Chickens and turkeys--(i) Amount per ton. Oleandomycin, 1 to 2 
grams.
    (ii) Indications for use. For increased rate of weight gain and 
improved feed efficiency for broiler chickens and growing turkeys.
    (2) Swine--(i) Amount per ton. Oleandomycin, 5 to 11.25 grams.
    (ii) Indications for use. For increased rate of weight gain and 
improved feed efficiency in growing-finishing swine.

[40 FR 13959, Mar. 27, 1975, as amended at 44 FR 40283, July 10, 1979; 
51 FR 7399, Mar. 3, 1986; 52 FR 2686, Jan. 26, 1987; 66 FR 47963, Sept. 
17, 2001]



Sec.  558.450  Oxytetracycline.

    (a) Approvals. Type A medicated articles:
    (1) 10, 20, 30, 50, 100, and 200 grams per pound to 066104 in Sec.  
510.600(c) of this chapter.
    (2) 50 and 100 grams per pound to 053389 in Sec.  510.600(c) of this 
chapter.
    (b) Special considerations. (1) 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.''
    (2) The articles in paragraph (a)(1) of this section contain an 
amount of mono-alkyl (C8-C18)

[[Page 451]]

trimethylammonium oxytetracycline expressed in terms of an equivalent 
amount of oxytetracycline hydrochloride or an amount of oxytetracycline 
dihydrate base expressed in terms of an equivalent amount of 
oxytetracycline hydrochloride.
    (3) The articles in paragraph (a)(2) of this section contain an 
amount of mono-alkyl (C8-C18) trimethylammonium 
oxytetracycline expressed in terms of an equivalent amount of 
oxytetracycline hydrochloride.
    (c) Related tolerances. See Sec.  556.500 of this chapter.
    (d)(1) Conditions of use. It is used in feed as follows:

                                                     Table 1
----------------------------------------------------------------------------------------------------------------
 Oxytetracycline amount          Combination          Indications for use          Limitations         Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 10 to 20 grams per    ........................  Sheep; increased rate    ......................      066104,
 ton (g/ton)                                         of weight gain and                                   053389
                                                     improved feed
                                                     efficiency.
(ii) 10 to 50 g/ton       ........................  1. Chickens; increased   Do not feed to                  Do.
                                                     rate of weight gain      chickens producing
                                                     and improved feed        eggs for human
                                                     efficiency.              consumption.
                          ........................  2. Growing turkeys;      Do not feed to turkeys          Do.
                                                     increased rate of        producing eggs for
                                                     weight and improved      human consumption.
                                                     feed efficiency.
                          ........................  3. Swine; increased      ......................          Do.
                                                     rate of weight and
                                                     improved feed
                                                     efficiency.
(iii) 100 g/ton           ........................  Turkeys; control of      Feed continuously for           Do.
                                                     hexamitiasis caused by   7 to 14 days (d); do
                                                     Hexamita meleagridis     not feed to turkeys
                                                     susceptible to           producing eggs for
                                                     oxytetracycline.         human consumption.
(iv) 100 to 200 g/ton     ........................  Chickens; control of     Feed continuously for           Do.
                                                     infectious synovitis     7 to 14 d; do not
                                                     caused by Mycoplasma     feed to chickens
                                                     synoviae; control of     producing eggs for
                                                     fowl cholera caused by   human consumption; in
                                                     Pasteurella multocida    low calcium feed,
                                                     susceptible to           withdraw 3 d before
                                                     oxytetracycline.         slaughter.
(v) 200 g/ton             ........................  Turkeys; control of      Feed continuously for       066104,
                                                     infectious synovitis     7 to 14 d; withdraw 5       053389
                                                     caused by M. synoviae    d before slaughter;
                                                     susceptible to           do not feed to
                                                     oxytetracycline.         turkeys producing
                                                                              eggs for human
                                                                              consumption.
(vi) 400 g/ton            ........................  Chickens; control of     Feed continuously for           Do.
                                                     chronic respiratory      7 to 14 d; do not
                                                     disease (CRD) and air    feed to chickens
                                                     sac infection caused     producing eggs for
                                                     by M. gallisepticum      human consumption; in
                                                     and Escherichia coli     low calcium feeds,
                                                     susceptible to           withdraw 3 d before
                                                     oxytetracycline.         slaughter.
(vii) 500 g/ton           ........................  Chickens; reduction of   Feed continuously for       066104,
                                                     mortality due to air     5 d; do not feed to         053389
                                                     sacculitis (air-sac-     chickens producing
                                                     infection) caused by     eggs for human
                                                     E. coli susceptible to   consumption; withdraw
                                                     oxytetracycline.         24 hours before
                                                                              slaughter; in low
                                                                              calcium feeds
                                                                              withdraw 3 d before
                                                                              slaughter.
                          Salinomycin 40 to 60 g/   Chickens; reduction of   ......do..............      012799,
                           ton                       mortality due to air                                 066104
                                                     sacculitis (air-sac-
                                                     infection) caused by
                                                     E. coli susceptible to
                                                     oxytetracycline;
                                                     prevention of
                                                     coccidiosis caused by
                                                     E. necatrix, E.
                                                     tenella, E.
                                                     acervulina, E.
                                                     brunetti, E. mivati,
                                                     and E. maxima.

[[Page 452]]

 
(viii) 0.05 to 0.1        ........................  Calves (up to 250 lb);   Feed continuously; in       066104,
 milligram/pound (mg/lb)                             for increased rate of    milk replacers or           053389
 of body weight daily.                               weight gain and          starter feed.
                                                     improved feed
                                                     efficiency.
(ix) 10 mg/lb of body     ........................  1.Calves and beef and    Feed continuously for           Do.
 weight daily.                                       nonlactating dairy       7 to 14 d; in feed or
                                                     cattle; treatment of     milk replacers;
                                                     bacterial enteritis      withdraw 5 d before
                                                     caused by E. coli and    slaughter.
                                                     bacterial pneumonia
                                                     (shipping fever
                                                     complex) caused by P.
                                                     multocida susceptible
                                                     to oxytetracycline.
                          ........................  2. Calves (up to 250     Feed continuously for           Do.
                                                     lb); treatment of        7 to 14 d; in milk
                                                     bacterial enteritis      replacers or starter
                                                     caused by E. coli        feed; withdraw 5 d
                                                     susceptible to           before slaughter.
                                                     oxytetracycline.
                          ........................  3. Sheep; treatment of   Feed continuously for           Do.
                                                     bacterial enteritis      7 to 14 d; withdraw 5
                                                     caused by E. coli and    d before slaughter.
                                                     bacterial pneumonia
                                                     caused by P. multocida
                                                     susceptible to
                                                     oxytetracycline.
                          ........................  4. Swine; treatment of   Feed continuously for           Do.
                                                     bacterial enteritis      7 to 14 d; for No.
                                                     caused by E. coli and    053389, withdraw 5 d
                                                     Salmonella               before slaughter; for
                                                     choleraesuis             No. 066104, zero-day
                                                     susceptible to           withdrawal.
                                                     oxytetracycline and
                                                     treatment of bacterial
                                                     pneumonia caused by P.
                                                     multocida susceptible
                                                     to oxytetracycline.
                          ........................  5. Breeding swine;       Feed continuously for           Do.
                                                     control and treatment    not more than 14 d;
                                                     of leptospirosis         for No. 053389,
                                                     (reducing the            withdraw 5 d before
                                                     incidence of abortion    slaughter; for No.
                                                     and shedding of          066104, zero-day
                                                     leptospirae) caused by   withdrawal.
                                                     Leptospira pomona
                                                     susceptible to
                                                     oxytetracycline.
(x) 25 mg/lb of body      ........................  Turkeys; control of      Feed continuously for           Do.
 weight                                              complicating bacterial   7 to 14 d; withdraw 5
                                                     organisms associated     d before slaughter;
                                                     with bluecomb            do not feed to
                                                     (transmissible           turkeys producing
                                                     enteritis; coronaviral   eggs for human
                                                     enteritis) susceptible   consumption.
                                                     to oxytetracycline.
(xi) 25 mg/head/day       ........................  Calves (250 to 400 lb);  ......................          Do.
                                                     increased rate of
                                                     weight gain and
                                                     improved feed
                                                     efficiency.
(xii) 75 mg/head/day      ........................  Growing cattle (over     ......................          Do.
                                                     400 lb); increased
                                                     rate of weight gain;
                                                     improved feed
                                                     efficiency, and
                                                     reduction of liver
                                                     condemnation due to
                                                     liver abscesses.
(xiii) 0.5 to 2.0 g/head/ ........................  Cattle; prevention and   Feed 3 to 5 d before            Do.
 day                                                 treatment of the early   and after arrival in
                                                     stages of shipping       feedlots.
                                                     fever complex.

[[Page 453]]

 
(xiv) 200 mg/colony       ........................  Honey bees; control of   Remove at least 6               Do.
                                                     American foulbrood       weeks prior to main
                                                     caused by Bacillus       honey flow.
                                                     larvae and European
                                                     foulbrood caused by
                                                     Streptococcus pluton
                                                     susceptible to
                                                     oxytetracycline.
----------------------------------------------------------------------------------------------------------------

    (2) It is used in fish feed as follows:

                                                     Table 2
----------------------------------------------------------------------------------------------------------------
 Oxytetracycline amount         Combination          Indications for use          Limitations          Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 250 mg/kilogram of    .......................  Pacific salmon for       For salmon not over 30        066104
 fish/d (11.35 g/100 lb                             marking of skeletal      g body weight;
 of fish/d).                                        tissue.                  administer as sole
                                                                             ration for 4
                                                                             consecutive days in
                                                                             feed containing
                                                                             oxytetracycline
                                                                             hydrochloride or mono-
                                                                             alkyl (C8-C18)
                                                                             trimethyl ammonium
                                                                             oxytetracycline; fish
                                                                             not to be liberated
                                                                             for at least 7 d
                                                                             following the last
                                                                             administration of
                                                                             medicated feed.
(ii) 2.5 to 3.75 g/100    .......................  1. Salmonids; control    Administer as mono-           066104
 lb of fish/d.                                      of ulcer disease         alkyl (C8-C18)
                                                    caused by Hemophilus     trimethyl ammonium
                                                    piscium, furunculosis    oxytetracycline in
                                                    caused by Aeromonas      mixed ration for 10 d;
                                                    salmonicida, bacterial   do not liberate fish
                                                    hemorrhagic septicemia   or slaughter fish for
                                                    caused by A.             food for 21 d
                                                    liquefaciens, and        following the last
                                                    pseudomonas disease.     administration of
                                                                             medicated feed; do not
                                                                             administer when water
                                                                             temperature is below 9
                                                                             [deg]C (48.2 [deg]F).
                          .......................  2. Catfish; control of   Administer as mono-           066104
                                                    bacterial hemorrhagic    alkyl (C8-C18)
                                                    septicemia caused by     trimethyl ammonium
                                                    A. liquefaciens and      oxytetracycline in
                                                    pseudomonas disease.     mixed ration for 10 d;
                                                                             do not liberate fish
                                                                             or slaughter fish for
                                                                             food for 21 d
                                                                             following the last
                                                                             administration of
                                                                             medicated feed; do not
                                                                             administer when water
                                                                             temperature is below
                                                                             16.7 [deg]C (62
                                                                             [deg]F)
(iii) 1 g/lb of           .......................  Lobsters; control of     Administer as sole            066104
 medicated feed.                                    gaffkemia caused by      ration for 5
                                                    Aerococcus viridans.     consecutive days in
                                                                             feed containing
                                                                             monoalkyl (C8-C18)
                                                                             trimethyl ammonium
                                                                             oxytetracycline;
                                                                             withdraw medicated
                                                                             feed 30 d before
                                                                             harvesting lobsters.
----------------------------------------------------------------------------------------------------------------

    (3) Oxytetracycline may be used in accordance with the provisions of 
this section in the combinations provided as follows:
    (i) Robenidine hydrochloride in accordance with Sec.  558.515.
    (ii) Lasalocid as in Sec.  558.311.

[[Page 454]]

    (iii) Melengestrol acetate as in Sec.  558.342.

[61 FR 51590, Oct. 3, 1996, as amended at 63 FR 41192, Aug. 3, 1998; 66 
FR 32740, June 18, 2001; 66 FR 45167, Aug. 28, 2001; 66 FR 47963, Sept. 
17, 2001; 67 FR 51081, Aug. 7, 2002]



Sec.  558.460  Penicillin.

    (a) Specifications. As penicillin procaine G or feed grade 
penicillin procaine.
    (b) Sponsors. Type A medicated articles: To 066104, 100 and 227 
grams per pound. To 046573, 100 and 227 grams per pound.
    (c) Related tolerances. See Sec.  556.510 of this chapter.
    (d) Conditions of use. (1) It is used as follows:

----------------------------------------------------------------------------------------------------------------
                                Combination in grams
 Penicillin in grams per ton          per ton            Indications for use         Limitations        Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 2.4 to 50...............  .......................  Chickens, turkeys, and  Do not feed to poultry    000069,
                                                        pheasants; for          producing eggs for       046573.
                                                        increased rate of       human consumption..
                                                        weight gain and
                                                        improved feed
                                                        efficiency..
(ii) 5 to 20................  .......................  Quail; for increased    Quail; not over 5             Do.
                                                        rate of weight gain     weeks of age..
                                                        and improved feed
                                                        efficiency..
(iii) 10 to 50..............  .......................  Swine; for increased    ......................        Do.
                                                        rate of weight gain
                                                        and improved feed
                                                        efficiency..
----------------------------------------------------------------------------------------------------------------

    (2) Penicillin may be used in accordance with the provisions of this 
section in the combinations provided as follows:
    (i) Amprolium in accordance with Sec.  558.55.
    (ii) Amprolium plus ethopatbate in accordance with Sec.  558.58.
    (iii)-(v) [Reserved]
    (vi) Hygromycin B in accordance with Sec.  558.274.
    (vii) Roxarsone and zoalene in accordance with Sec.  558.680.
    (viii) Zoalene in accordance with Sec.  558.680.

[41 FR 11004, Mar. 15, 1976, as amended at 42 FR 18618, Apr. 8, 1977; 42 
FR 36995, July 19, 1977; 47 FR 42103, Sept. 24, 1982; 51 FR 7399, Mar. 
3, 1986; 52 FR 2686, Jan. 26, 1987; 58 FR 30120, May 26, 1993; 60 FR 
39847, Aug. 4, 1995; 63 FR 36179, July 2, 1998; 65 FR 45880, July 26, 
2000; 66 FR 47963, Sept. 17, 2001]



Sec.  558.464  Poloxalene.

    (a) Approvals. (1) Dry Type A medicated articles: 53 percent to 
000069 in Sec.  510.600(c) of this chapter.
    (2) Liquid Type A medicated articles: 99.5 percent to 000069 in 
Sec.  510.600(c) of this chapter.
    (b) 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



Sec.  558.465  Poloxalene free-choice liquid Type C feed.

    (a) Approvals. Type A medicated articles: 99.5 percent to 066104 in 
Sec.  510.600(c) of this chapter.
    (b) Conditions of use. (1) For control of legume (alfalfa, clover) 
and wheat pasture bloat in cattle, use 7.5 grams of poloxalene per pound 
of liquid Type C feed (1.65 percent weight/weight). Each animal must 
consume 0.2 pound of

[[Page 455]]

Type C feed per 100 pounds of body weight daily for adequate protection.
    (2) For control of legume (alfalfa, clover) bloat in cattle grazing 
of prebloom legumes, use 10.00 grams of poloxalene per pound of liquid 
Type C feed (2.2 percent weight/weight). Each animal must consume 0.15 
pound of Type C feed per 100 pounds of body weight daily for adequate 
protection. If consumption exceeds 0.2 pound of Type C feed per 100 
pounds of body weight daily, cattle should be changed to a Type C feed 
containing 7.5 grams of poloxalene per pound.
    (3) Poloxalene liquid Type A article must be thoroughly blended and 
evenly distributed into a liquid Type C feed and offered to cattle in a 
covered liquid Type C feed feeder with lick wheels. The formula for the 
liquid Type C feed, on a weight/weight basis, is as follows: Ammonium 
polyphosphate 2.66 percent, phosphoric acid (75 percent) 3.37 percent, 
sulfuric acid 1.00 percent, water 10.00 percent, and molasses sufficient 
to make 100.00 percent, vitamins A and D and/or trace minerals may be 
added. One free-turning lick wheel per 25 head of cattle must be 
provided.
    (4) The medicated liquid Type C feed must be introduced at least 2 
to 5 days before legume consumption to accustom the cattle to the 
medicated liquid Type C feed and to lick wheel feedings. If the 
medicated liquid wheel Type C feed feeding is interrupted, this 2- to 5-
day introductory feeding should be repeated.

[40 FR 13959, Mar. 27, 1975, as amended at 42 FR 21281, Apr. 26, 1977; 
51 FR 7399, Mar. 3, 1986; 52 FR 2686, Jan. 26, 1987; 56 FR 50654, Oct. 
8, 1991; 60 FR 55660, Nov. 2, 1995; 66 FR 47963, Sept. 17, 2001]



Sec.  558.485  Pyrantel tartrate.

    (a) Specifications. Type A medicated articles containing 9.6, 19.2, 
48, or 80 grams per pound pyrantel tartrate.
    (b) Approvals. See sponsors in Sec.  510.600(c) of this chapter for 
uses as in paragraph (e) of this section:
    (1) No. 066104: 9.6, 19.2, and 80 grams per pound for use as in 
paragraph (e)(1) of this section.
    (2) No. 001800: 9.6 grams per pound for use as in paragraphs 
(e)(1)(i) through (e)(1)(iii) of this section.
    (3) Nos. 010439, 011490, 011749, 016968, 017473, 017519, 017790, 
043733, 049685, 050568, 050639, and 051359: 9.6 and 19.2 grams per pound 
for use as in paragraphs (e)(1)(i) through (e)(1)(iii) of this section.
    (4) No. 021676: 19.2 grams per pound for use as in paragraphs 
(e)(1)(i) through (e)(1)(iii) of this section.
    (5) No. 017800: 19.2 and 48 grams per pound for use as in paragraphs 
(e)(1)(i) through (e)(1)(iii) of this section.
    (6) Nos. 034936 and 046987: 9.6 and 19.2 grams per pound for use as 
in paragraphs (e)(1)(i) and (e)(1)(ii) of this section.
    (7) Nos. 000069 and 017135: 48 grams per pound for use as in 
paragraph (e)(2) of this section.
    (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. It is used as follows:
    (1) Swine--(i) Amount per ton. 96 grams (0.0106 percent).
    (A) Indications for use. 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.
    (B) Limitations. Feed continuously as the sole ration in a Type C 
feed; withdraw 24 hours prior to slaughter.
    (ii) Amount per ton. 96 grams (0.0106 percent).
    (A) Indications for use. For the removal and control of large 
roundworm (Ascaris suum) infections.
    (B) Limitations. Feed for 3 days as the sole ration in a Type C 
feed; withdraw 24 hours prior to slaughter.
    (iii) Amount per ton. 800 grams (0.0881 percent).
    (A) Indications for use. For the removal and control of large 
roundworm (Ascaris suum) and nodular worm (Oesophagostomum) infections.
    (B) Limitations. As sole ration for a single therapeutic treatment 
in Type C feed; feed at the rate of 1 lb of feed per 40 lb of body 
weight for animals up to

[[Page 456]]

200 lb, and 5 lb of feed per head for animals 200 lb or over; withdraw 
24 hours prior to slaughter.
    (iv) Amount per ton. Pyrantel tartrate, 96 grams (0.0106 percent) 
and carbadox, 50 grams (0.0055 percent).
    (A) 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.
    (B) Limitations. Do not feed to swine weighing 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 Type C feeds containing less than 15 percent crude 
protein.
    (v) Amount per ton. Pyrantel tartrate, 96 grams (0.0106 percent) and 
tylosin, 40 to 100 grams, as tylosin phosphate.
    (A) Indications for use. For prevention of swine dysentery 
(vibrionic); aid in the prevention of migration and establishment of 
large roundworms (Ascaris suum) infections; aid in the prevention of 
establishment of nodular worm (Oesophagostomum spp.) infections.
    (B) Limitations. Use 100 grams tylosin per ton for at least 3 weeks 
followed by 40 grams tylosin per ton until market weight; withdraw 24 
hours before slaughter. Consult your veterinarian before feeding to 
severely debilitated animals and for assistance in the diagnosis, 
treatment, and control of parasitism.
    (vi) Amount per ton. Pyrantel tartrate, 96 grams (0.0106 percent) 
and tylosin 40 to 100 grams, as tylosin phosphate.
    (A) Indications for use. Treatment and control of swine dysentery 
(vibrionic); aid in the prevention of migration and establishment of 
large roundworm (Ascaris suum) infections; aid in the prevention of 
establishment of nodular worm (Oesophagostomum spp.) infections.
    (B) Limitations. Administer tylosin in feed as tylosin phosphate 
after treatment with tylosin in drinking water as tylosin base; 0.25 
grams per gallon in drinking water for 3 to 10 days, 40 to 100 grams 
tylosin per ton in feed for 2 to 6 weeks; withdraw 24 hours before 
slaughter. Consult your veterinarian before feeding to severely 
debilitated animals and for assistance in the diagnosis, treatment, and 
control of parasitism.
    (vii) Amount per ton. Pyrantel tartrate, 96 grams (0.0106 percent) 
and lincomycin, 40 grams, as lincomycin hydrochloride monohydrate.
    (A) Indications for use. For control of swine dysentery; aid in the 
prevention of migration and establishment of large roundworm (Ascaris 
suum) infections; aid in the prevention of establishment of nodular worm 
(Oesophagostomum spp.) infections.
    (B) Limitations. Feed as sole ration; for use in swine on premises 
with a history of swine dysentery but where symptoms have not yet 
occurred; not to be fed to swine that weigh more than 250 pounds; 
withdraw 6 days before slaughter. Consult your veterinarian before 
feeding to severely debilitated animals and for assistance in the 
diagnosis, treatment, and control of parasitism.
    (viii) Amount per ton. Pyrantel tartrate, 96 grams (0.0106 percent) 
and lincomycin, 100 grams, then 40 grams, as lincomycin hydrochloride 
monohydrate.
    (A) Indications for use. For treatment and control of swine 
dysentery; aid in the prevention of migration and establishment of large 
roundworm (Ascaris suum) infections; aid in the prevention of 
establishment of nodular worm (Oesophagostomum spp.) infections.
    (B) Limitations. Feed 100 grams per ton for 3 weeks or until signs 
of disease disappear, followed by 40 grams per ton; feed as sole ration; 
not to be fed to swine that weigh more than 250 pounds; withdraw 6 days 
before slaughter. Consult your veterinarian before feeding to severely 
debilitated animals and for assistance in the diagnosis, treatment, and 
control of parasitism.
    (ix) Amount per ton. Pyrantel tartrate, 96 grams (0.0106 percent) 
and lincomycin, 100 grams, as lincomycin hydrochloride monohydrate.

[[Page 457]]

    (A) Indications for use. For treatment of swine dysentery; aid in 
the prevention of migration and establishment of large roundworm 
(Ascaris suum) infections; aid in the prevention of establishment of 
nodular worm (Oesophagostomum spp.) infections.
    (B) Limitations. Feed 100 grams per ton 3 weeks or until signs of 
disease disappear, followed by 40 grams per ton; feed as sole ration; 
not to be fed to swine that weigh more than 250 pounds; withdraw 6 days 
before slaughter. Consult your veterinarian before feeding to severely 
debilitated animals and for assistance in the diagnosis, treatment, and 
control of parasitism.
    (x) Amount per ton. Pyrantel tartrate, 96 grams (0.0106 percent) and 
lincomycin, 100 or 40 grams.
    (A) Indications for use. For treatment and/or control of swine 
dysentery; for removal and control of large roundworm (Ascaris suum) 
infections.
    (B) Limitations. Administer in accordance with paragraph (c)(2)(i), 
(c)(2)(ii), or (c)(2)(iii) of Sec.  558.325 and paragraph (e)(1)(ii)(B) 
of this section.
    (xi) Amount per ton. Pyrantel tartrate, 800 grams (0.0881 percent) 
and lincomycin, 100 or 40 grams.
    (A) Indications for use. For treatment and/or control of swine 
dysentery; for removal and control of large roundworm (Ascaris suum) and 
nodular worm (Oesophagostomum spp.) infections.
    (B) Limitations. Administer in accordance with paragraph (c)(2)(i), 
(c)(2)(ii), or (c)(2)(iii) of Sec.  558.325 and paragraph (e)(1)(iii)(B) 
of this section.
    (xii) Amount per ton. Pyrantel tartrate, 96 grams (0.0106 percent) 
and lincomycin, 200 grams as lincomycin hydrochloride monohydrate.
    (A) Indications for use. For the reduction in severity of swine 
mycoplasma pneumonia caused by Mycoplasma hyopneumoniae; aid in the 
prevention of migration and establishment of large roundworms (Ascaris 
suum) infections; aid in the prevention of establishment of nodular worm 
(Oesophagostomum spp.) infections.
    (B) Limitations. Feed as sole ration for 21 days; not to be fed to 
swine that weigh more than 250 pounds; withdraw 6 days before slaughter; 
consult your veterinarian before feeding to severely debilitated animals 
and for assistance in the diagnosis, treatment, and control of 
parasitism.
    (C) Sponsor. See No. 000009 in Sec.  510.600(c) of this chapter.
    (2) Horses--(i) Amount. Feed continuously at the rate of 1.2 
milligrams per pound (2.64 milligrams per kilogram) of body weight.
    (A) Indications for use. Prevention of Strongylus vulgaris larval 
infections; control of adult large strongyles (S. vulgaris, and S. 
edentatus), adult and 4th stage larvae small strongyles (Cyathostomum 
spp., Cylicocyclus spp., Cylicostephanus spp., Cylicodontophorus spp., 
Poteriostomum spp., and Triodontophorus spp.), adult and 4th stage 
larvae pinworms (Oxyuris equi), and adult and 4th stage larvae ascarids 
(Parascaris equorum).
    (B) Limitations. Administer either as a top-dress (not to exceed 
20,000 grams per ton) or mixed in the horse's daily grain ration (not to 
exceed 1,200 grams per ton) during the time that the animal is at risk 
of exposure to internal parasites. Not for use in horses intended for 
food. Consult your veterinarian before using in severely debilitated 
animals and for assistance in the diagnosis, treatment, and control of 
parasitism.
    (ii) [Reserved]

[40 FR 13959, Mar. 27, 1975]

    Editorial Note: For Federal Register citations affecting Sec.  
558.485, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and on GPO Access.



Sec.  558.500  Ractopamine.

    (a) Specifications. Type A medicated articles containing 9 or 45 
grams of ractopamine hydrochloride per pound.
    (b) Approvals. See No. 000986 in Sec.  510.600(c) of this chapter.
    (c) Related tolerances. See Sec.  556.570 of this chapter.
    (d) Special considerations. (1) Labeling of Type B and Type C swine 
feeds shall bear the following:
    (i) ``Caution: Pigs fed PAYLEAN are at an increased risk for 
exhibiting the downer pig syndrome (also referred to as ``slows,'' 
``subs,'' or ``suspects''). Pig

[[Page 458]]

handling methods to reduce the incidence of downer pigs should be 
thoroughly evaluated prior to initiating use of PAYLEAN.''
    (ii) ``Not for use in breeding swine.''
    (2) Tylosin in combinations as tylosin phosphate.
    (e) Conditions of use. (1) Swine--

----------------------------------------------------------------------------------------------------------------
 Ractopamine in    Combination in
    grams/ton         grams/ton           Indications for use                  Limitations              Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 4.5           ................  For increased rate of weight     Feed continuously as sole            000986
                                     gain, improved feed              ration.
                                     efficiency, and increased
                                     carcass leanness in finishing
                                     swine fed a complete ration
                                     containing at least 16 percent
                                     crude protein from 150 lb (68
                                     kg) to 240 lb (109 kg) body
                                     weight.
(ii) 4.5          Tylosin 40        Finishing swine: As in           Feed continuously as sole            000986
                                     paragraph (e)(1)(i) of this      ration until market weight
                                     section; and for prevention of   following the use of tylosin
                                     swine dysentery (vibrionic).     at 100 grams per ton (g/t) for
                                                                      at least 3 weeks.
(iii) 4.5         Tylosin 100       1. Finishing swine: As in        Feed continuously as sole            000986
                                     paragraph (e)(1)(i) of this      ration for 21 days.                 000986
                                     section; and for prevention     Feed continuously as sole
                                     and/or control of porcine        ration for at least 3 weeks
                                     proliferative enteropathies      followed by tylosin at 40 g/t
                                     (ileitis) associated with        until market weight.
                                     Lawsonia intracellularis.
                                    2. Finishing swine: As in
                                     paragraph (e)(1)(i) of this
                                     section; and for prevention of
                                     swine dysentery (vibrionic).
(iv) 4.5 to 18    ................  For improved feed efficiency     Feed continuously as sole            000986
                                     and increased carcass leanness   ration.
                                     in finishing swine fed a
                                     complete ration containing at
                                     least 16 percent crude protein
                                     from 150 lb (68 kg) to 240 lb
                                     (109 kg) body weight.
(v) 4.5 to 18     Tylosin 40        Finishing swine: As in           Feed continuously as sole            000986
                                     paragraph (e)(1)(iv) of this     ration until market weight
                                     section; and for prevention of   following the use of tylosin
                                     swine dysentery (vibrionic).     at 100 g/t for at least 3
                                                                      weeks.
(vi) 4.5 to 18    Tylosin 100       1. Finishing swine: As in        Feed continuously as sole            000986
                                     paragraph (e)(1)(iv) of this     ration for 21 days.                 000986
                                     section; and for prevention     Feed continuously as sole
                                     and/or control of porcine        ration for at least 3 weeks
                                     proliferative enteropathies      followed by tylosin at 40 g/t
                                     (ileitis) associated with        until market weight.
                                     Lawsonia intracellularis.
                                    2. Finishing swine: As in
                                     paragraph (e)(1)(iv) of this
                                     section; and for prevention of
                                     swine dysentery (vibrionic).
----------------------------------------------------------------------------------------------------------------

    (2) [Reserved]

[67 FR 71820, Dec. 3, 2002]



Sec.  558.515  Robenidine hydrochloride.

    (a) Approvals. Type A medicated articles: 30 grams per pound to 
046573 in Sec.  510.600(c) of this chapter.
    (b) 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.
    (c) Related tolerances. See Sec.  556.580 of this chapter.
    (d) Conditions of use. It is used in feed for chickens as follows:

------------------------------------------------------------------------
   Robenidine
 hydrochloride    Combination   Indications for   Limitations    Sponsor
  in grams/ton   in  grams/ton        use
------------------------------------------------------------------------
30 (0.0033 pct)  .............  For broiler and  Feed           046573
                                 fryer            continuously
                                 chickens: As     as sole
                                 an aid in the    ration. Do
                                 prevention of    not feed to
                                 coccidiosis      layers.
                                 caused by E.     Withdraw 5
                                 mivati, E.       days prior
                                 brunetti, E.     to
                                 tenella, E.      slaughter.
                                 acervulina, E.
                                 maxima, and E.
                                 necatrix.

[[Page 459]]

 
                 Bacitracin     For broiler and  Feed           046573
                  (as            fryer            continuously
                  bacitracin     chickens: As     as sole
                  methylene      an aid in the    ration. Do
                  disalicylate   prevention of    not feed to
                  ) 4 to 30      coccidiosis      laying
                                 caused by E.     chickens.
                                 mivati, E.       Withdraw 5
                                 brunetti, E.     days prior
                                 tenella, E.      to
                                 acervulina, E.   slaughter.
                                 maxima, and E.
                                 necatrix. For
                                 increased rate
                                 of weight
                                 gain.
                 Bacitracin     For broiler and  Feed           046573
                  (as            fryer            continuously
                  bacitracin     chickens: As     as sole
                  methylene      an aid in the    ration. Do
                  disalicylate   prevention of    not feed to
                  ) 27 to 50     coccidiosis      laying
                                 caused by E.     chickens.
                                 mivati, E.       Withdraw 5
                                 brunetti, E.     days prior
                                 tenella, E.      to
                                 acervulina, E.   slaughter.
                                 maxima, and E.
                                 necatrix. For
                                 improved feed
                                 efficiency.
                 Bacitracin     For broiler and  Feed           046573
                  (as            fryer            continuously
                  bacitracin     chickens: As     as sole
                  methylene      an aid in the    ration. Do
                  disalicylate   prevention of    not feed to
                  ) 50           necrotic         laying hens.
                                 enteritis        Withdraw 5
                                 caused or        days before
                                 complicated by   slaughter.
                                 Clostridium
                                 spp. or other
                                 organisms
                                 susceptible to
                                 bacitracin.
                 Bacitracin     For broiler and  To control a   046573
                  (as            fryer            necrotic
                  bacitracin     chickens: As     enteritis
                  methylene      an aid in the    outbreak,
                  disalicylate   control of       start
                  ) 100 to 200   necrotic         medication
                                 enteritis        at first
                                 caused or        clinical
                                 complicated by   signs of
                                 Clostridium      disease;
                                 spp. or other    administer
                                 organisms        continuously
                                 susceptible to   for 5 to 7
                                 bacitracin.      days or as
                                                  long as
                                                  clinical
                                                  signs
                                                  persist,
                                                  then reduce
                                                  bacitracin
                                                  methylene
                                                  disalicylate
                                                  to
                                                  prevention
                                                  level (50 g/
                                                  ton). Do not
                                                  feed to
                                                  laying hens.
                                                  Withdraw 5
                                                  days before
                                                  slaughter.
                 Bacitracin     For broiler      Feed           046573
                  (as            chickens: As     continuously
                  bacitracin     an aid in the    as sole
                  methylene      prevention of    ration. Use
                  disalicylate   coccidiosis      as the sole
                  ) 50 and       caused by E.     source of
                  roxarsone      mivati, E.       organic
                  22.7 to 45.4   brunetti, E.     arsenic;
                                 tenella, E.      poultry
                                 acervulina, E.   should have
                                 maxima, and E.   access to
                                 necatrix. As     water at all
                                 an aid in the    times; drug
                                 prevention of    overdose or
                                 necrotic         lack of
                                 enteritis        water intake
                                 caused or        may result
                                 complicated by   in leg
                                 Clostridium      weakness or
                                 spp. or other    paralysis.
                                 organisms        Do not feed
                                 susceptible to   to laying
                                 bacitracin.      chickens.
                                 For increased    Withdraw 5
                                 rate of weight   days prior
                                 gain, improved   to
                                 feed             slaughter.
                                 efficiency,
                                 and improved
                                 pigmentation.

[[Page 460]]

 
                 Bacitracin     For broiler      To control     046573
                  (as            chickens: As     necrotic
                  bacitracin     an aid in the    enteritis,
                  methylene      prevention of    start
                  disalicylate   coccidiosis      medication
                  ) 100 to 200   caused by E.     at first
                  and            mivati, E.       clinical
                  roxarsone      brunetti, E.     signs of
                  22.7 to 45.4   tenella, E.      disease;
                                 acervulina, E.   vary
                                 maxima, and E.   bacitracin
                                 necatrix. As     dosage based
                                 an aid in the    on the
                                 control of       severity of
                                 necrotic         infection;
                                 enteritis        administer
                                 caused or        continuously
                                 complicated by   for 5 to 7
                                 Clostridium      days or as
                                 spp. or other    long as
                                 organisms        clinical
                                 susceptible to   signs
                                 bacitracin.      persist,
                                 For increased    then reduce
                                 rate of weight   bacitracin
                                 gain, improved   to
                                 feed             prevention
                                 efficiency,      level (50 g/
                                 and improved     ton). Use as
                                 pigmentation.    the sole
                                                  source of
                                                  organic
                                                  arsenic;
                                                  poultry
                                                  should have
                                                  access to
                                                  water at all
                                                  times; drug
                                                  overdose or
                                                  lack of
                                                  water intake
                                                  may result
                                                  in leg
                                                  weakness or
                                                  paralysis.
                                                  Do not feed
                                                  to laying
                                                  chickens.
                                                  Withdraw 5
                                                  days prior
                                                  to
                                                  slaughter.
                 Bacitracin     For broiler and  Feed           046573
                  (as            fryer            continuously  046573
                  bacitracin     chickens: As     as sole
                  zinc) 4 to     an aid in the    ration. Do
                  30             prevention of    not feed to
                                 coccidiosis      laying
                                 caused by E.     chickens.
                                 mivati, E.       Withdraw 5
                                 brunetti, E.     days prior
                                 tenella, E.      to
                                 acervulina, E.   slaughter.
                                 maxima, and E.
                                 necatrix. For
                                 increased rate
                                 of weight
                                 gain.
                 Bacitracin     For broiler and  Feed           046573
                  (as            fryer            continuously  046573
                  bacitracin     chickens: As     as sole
                  zinc) 27 to    an aid in the    ration. Do
                  50             prevention of    not feed to
                                 coccidiosis      laying
                                 caused by E.     chickens.
                                 mivati, E.       Withdraw 5
                                 brunetti, E.     days prior
                                 tenella, E.      to
                                 acervulina, E.   slaughter.
                                 maxima, and E.
                                 necatrix. For
                                 improved feed
                                 efficiency.
                 Chlortetracyc  For broiler and  Feed           ........
                  line 100 to    fryer            continuously
                  200            chickens: As     as sole
                                 an aid in the    ration up to
                                 prevention of    14 days. Do
                                 coccidiosis      not feed to
                                 caused by E.     chickens
                                 mivati, E.       producing
                                 brunetti, E.     eggs for
                                 tenella, E.      human
                                 acervulina, E.   consumption.
                                 maxima, and E.   Withdraw 5
                                 necatrix. For    days prior
                                 control of       to
                                 infectious       slaughter.
                                 synovitis
                                 caused by
                                 Mycoplasma
                                 synoviae
                                 susceptible to
                                 chlortetracycl
                                 ine.
                 Chlortetracyc  For broiler and  Feed           ........
                  line 200 to    fryer            continuously
                  400            chickens: As     as sole
                                 an aid in the    ration up to
                                 prevention of    14 days. Do
                                 coccidiosis      not feed to
                                 caused by E.     chickens
                                 mivati, E.       producing
                                 brunetti, E.     eggs for
                                 tenella, E.      human
                                 acervulina, E.   consumption.
                                 maxima, and E.   Withdraw 5
                                 necatrix. For    days prior
                                 control of       to
                                 chronic          slaughter.
                                 respiratory
                                 disease (CRD)
                                 and air sac
                                 infection
                                 caused by M.
                                 gallisepticum
                                 and E coli
                                 susceptible to
                                 chlortetracycl
                                 ine.
                 Chlortetracyc  For broiler and  Feed           046573
                  line 500       fryer            continuously
                                 chickens: As     as sole
                                 an aid in the    ration up to
                                 prevention of    5 days. Do
                                 coccidiosis      not feed to
                                 caused by E.     chickens
                                 mivati, E.       producing
                                 brunetti, E.     eggs for
                                 tenella, E.      human
                                 acervulina, E.   consumption.
                                 maxima, and E.   Withdraw 5
                                 necatrix. As     days prior
                                 an aid in the    to
                                 reduction of     slaughter.
                                 mortality due
                                 to E. coli
                                 susceptible to
                                 chlortetracycl
                                 ine.

[[Page 461]]

 
                 Lincomycin 2   For broiler and  Feed           000009
                                 fryer            continuously
                                 chickens: As     as the sole
                                 an aid in the    ration. Do
                                 prevention of    not feed to
                                 coccidiosis      laying hens.
                                 caused by E.     Withdraw 5
                                 mivati, E.       days before
                                 brunetti, E.     slaughter.
                                 tenella, E.
                                 acervulina, E.
                                 maxima, and E.
                                 necatrix. For
                                 increase in
                                 rate of weight
                                 gain and
                                 improved feed
                                 efficiency.
                 Oxytetracycli  For broiler      Feed           066104
                  ne 400         chickens: As     continuously
                                 an aid in the    for 7 to 14
                                 prevention of    days. Do not
                                 coccidiosis      feed to
                                 caused by E.     chickens
                                 mivati, E.       producing
                                 brunetti, E.     eggs for
                                 tenella, E.      human
                                 acervulina, E.   consumption.
                                 maxima, and E.   Withdraw 5
                                 necatrix. For    days before
                                 control of CRD   slaughter.
                                 and air sac
                                 infection
                                 caused by
                                 Mycoplasma
                                 gallisepticum
                                 and E. coli
                                 susceptible to
                                 oxytetracyclin
                                 e.
                 Roxarsone      For broiler and  Feed           046573
                  22.5 to 45.4   fryer            continuously
                  (0.005         chickens: As     as the sole
                  percent)       an aid in the    ration. Use
                                 prevention of    as sole
                                 coccidiosis      source of
                                 caused by E.     organic
                                 mivati, E.       arsenic. Do
                                 brunetti, E.     not feed to
                                 tenella, E.      layers.
                                 acervulina, E.   Withdraw 5
                                 maxima, and E.   days prior
                                 necatrix. For    to
                                 increased rate   slaughter.
                                 of weight
                                 gain.
------------------------------------------------------------------------


[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 on GPO Access.



Sec.  558.530  Roxarsone.

    (a) Approvals. Type A medicated articles: 10, 20, 50, and 80 percent 
to 046573 in Sec.  510.600(c) of this chapter for use as in paragraphs 
(d)(1) through (d)(4) of this section.
    (b) Related tolerances. See Sec.  556.60 of this chapter.
    (c) [Reserved]
    (d) Conditions of use--(1) Growing chickens and growing turkeys--(i) 
Grams per ton. Roxarsone 22.7 and 45.4 (0.0025 to 0.005 percent).
    (ii) Indications for use. For increased rate of weight gain, 
improved feed efficiency, and improved pigmentation.
    (iii) Limitations. Withdraw 5 days before slaughter; as sole source 
of organic arsenic; drug overdose or lack of water may result in leg 
weakness; feed continuously throughout growing period.
    (2) Growing chickens--(i) Grams per ton. Roxarsone, 22.7 to 45.4 
(0.0025 to 0.005 percent) plus chlortetracycline, 10 to 50.
    (A) Indications for use. For increased rate of weight gain, improved 
feed efficiency, and improved pigmentation.
    (B) Limitations. Do not feed to chickens producing eggs for human 
consumption; withdraw 5 days before slaughter; as sole source of organic 
arsenic; drug overdose or lack of water may result in leg weakness; feed 
continuously throughout growing period.
    (ii) Grams per ton. Roxarsone 22.7 to 45.4 (0.0025 to 0.005 percent) 
plus chlortetracycline, 100 to 200.
    (A) Indications for use. For increased rate of weight gain, improved 
feed efficiency, and improved pigmentation; control of infectious 
synovitis caused by Mycoplasma synoviae susceptible to 
chlortetracycline.
    (B) Limitations. See paragraph (d)(2)(i)(B) of this section except 
feed continuously for 7 to 14 days.
    (iii) Grams per ton. Roxarsone 22.7 to 45.4 (0.0025 to 0.005 
percent) plus chlortetracycline, 200 to 400.
    (A) Indications for use. For increased rate of weight gain, improved 
feed efficiency, and improved pigmentation; control of chronic 
respiratory disease (CRD) and air sac infection caused by M. 
gallisepticum and Escherichia coli susceptible to chlortetracycline.
    (B) Limitations. See paragraph (d)(2)(i)(B) of this section except 
feed continuously for 7 to 14 days.
    (iv) Grams per ton. Roxarsone 22.7 to 45.4 (0.0025 to 0.005 percent) 
plus chlortetracycline, 500.

[[Page 462]]

    (A) Indications for use. For increased rate of weight gain, improved 
feed efficiency, and improved pigmentation; reduction of mortality due 
to E. coli infections susceptible to chlortetracycline.
    (B) Limitations. See paragraph (d)(2)(i)(B) of this section except 
feed for 5 days.
    (3) Growing turkeys--(i) Grams per ton. Roxarsone 22.7 to 45.4 
(0.0025 to 0.005 percent) plus chlortetracycline, 10 to 50.
    (A) Indications for use. For increased rate of weight gain, improved 
feed efficiency, and improved pigmentation.
    (B) Limitations. Do not feed to turkeys producing eggs for human 
consumption; withdraw 5 days before slaughter; as sole source of organic 
arsenic; drug overdose or lack of water may result in leg weakness; feed 
continuously throughout growing season.
    (ii) Grams per ton. Roxarsone 22.7 to 45.4 (0.0025 to 0.005 percent) 
plus chlortetracycline 200.
    (A) Indications for use. For increased rate of weight gain, improved 
feed efficiency, and improved pigmentation; control of infectious 
synovitis caused by M. synoviae susceptible to chlortetracycline.
    (B) Limitations. See paragraph (d)(3)(i)(B) of this section except 
that the drug should only be fed continuously for 7 to 14 days.
    (iii) Grams per ton. Roxarsone 22.7 to 45.4 (0.0025 to 0.005 
percent) plus chlortetracycline, 400.
    (A) Indications for use. For increased rate of weight gain, improved 
feed efficiency, and improved pigmentation; control of hexamitiasis 
caused by Hexamita meleagrides susceptible to chlortetracycline. Turkey 
poults not over 4 weeks of age: Reduction of mortality due to 
paratyphoid caused by Salmonella typhimurium susceptible to 
chlortetracycline.
    (B) Limitations. See paragraph (d)(3)(i)(B) of this section except 
that the drug should only be fed continuously for 7 to 14 days.
    (iv) Amount. Roxarsone 22.7 to 45.4 grams per ton (0.0025 to 0.005 
percent) plus chlortetracycline, 25 milligrams per pound of body weight 
daily.
    (A) Indications for use. For increased rate of weight gain, improved 
feed efficiency, and improved pigmentation; control of complicating 
bacterial organisms associated with bluecomb (transmissible enteritis, 
coronaviral enteritis) susceptible to chlortetracycline.
    (B) Limitations. See paragraph (d)(3)(i)(B) of this section except 
that the drug should only be fed continuously for 7 to 14 days.
    (4) Growing-finishing swine--(i) Grams per ton. Roxarsone 22.7 to 
34.1 (0.0025 to 0.00375 percent).
    (A) Indications for use. For increased rate of weight gain and 
improved feed efficiency.
    (B) Limitations. Withdraw 5 days before slaughter; as sole source of 
organic arsenic; feed continuously throughout growing season.
    (ii) Grams per ton. Roxarsone 22.7 to 34.1 (0.0025 to 0.00375 
percent) plus chlortetracycline, 400 (to administer 10 milligrams per 
pound of body weight).
    (A) Indications for use. For increased rate of weight gain and 
improved feed efficiency; treatment of bacterial enteritis caused by E. 
coli and S. choleraesuis and bacterial pneumonia caused by P. multocida 
susceptible to chlortetracycline.
    (B) Limitations. Withdraw 5 days before slaughter; as sole source of 
organic arsenic; feed for not more than 14 days.
    (iii) Grams per ton. Roxarsone 181.5 (0.02 percent).
    (A) Indications for use. For the treatment of swine dysentery.
    (B) Limitations. Feed for not more than 6 consecutive days; if 
improvement is not observed, consult a veterinarian; withdraw 5 days 
before slaughter; as a sole source or organic arsenic; animals must 
consume enough medicated feed to provide a therapeutic dose.
    (iv) Grams per ton. Roxarsone, 181.5 (0.02 percent) plus 
chlortetracycline, 10 to 50.
    (A) Indications for use. For the treatment of swine dysentery; 
increased rate of weight gain and improved feed efficiency.
    (B) Limitations. See paragraph (d)(4)(iii)(B) of this section.
    (v) Grams per ton. Roxarsone, 181.5 (0.02 percent) plus 
chlortetracycline, 400.
    (A) Indications for use. For the treatment of swine dysentery; 
treatment of

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bacterial enteritis caused by E. coli and S. choleraesuis and bacterial 
pneumonia caused by P. multocida susceptible to chlortetracycline.
    (B) Limitations. See paragraph (d)(4)(iii)(B) of this section.
    (5) Permitted combinations. It may be used in accordance with this 
section in combination with:
    (i) Aklomide as in Sec.  558.35.
    (ii) Amprolium as in Sec.  558.55.
    (iii) Amprolium and ethopabate as in Sec.  558.58.
    (iv) Bacitracin methylene disalicylate as in Sec.  558.76.
    (v) Bacitracin zinc as in Sec.  558.78.
    (vi) Bambermycins and bambermycins plus certain anticoccidials as in 
Sec.  558.95.
    (vii) Chlortetracycline as in Sec.  558.128.
    (viii) Clopidol as in Sec.  558.175.
    (ix) Decoquinate alone or in combination as in Sec.  558.195.
    (x) Diclazuril alone or in combination as in Sec.  558.198.
    (xi) Halofuginone alone or in combination as in Sec.  558.265.
    (xii) Lasalocid alone or in combination as in Sec.  558.311.
    (xiii) Monensin alone or in combination as in Sec.  558.355.
    (xiv) Narasin alone or in combination as in Sec.  558.363.
    (xv) Nequinate as in Sec.  558.365.
    (xvi) Nicarbazin alone or in combination as in Sec.  558.366.
    (xvii) Nitromide and sulfanitran as in Sec.  558.376.
    (xviii) Penicillin and zoalene as in Sec.  558.680.
    (xix) Robenidine hydrochloride as in Sec.  558.515.
    (xx) Salinomycin alone or in combination as in Sec.  558.550.
    (xxi) Semduramicin alone or in combination as in Sec.  558.555.
    (xxii) Sulfadimethoxine, ormetoprim as in Sec.  558.575.
    (xxiii) Zoalene alone or in combination as in Sec.  558.680.

[46 FR 52331, Oct. 27, 1981]

    Editorial Note: For Federal Register citations affecting Sec.  
558.530, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and on GPO Access.



Sec.  558.550  Salinomycin.

    (a) Approvals. Type A medicated articles containing 30 or 60 grams 
of salinomycin activity per pound (as salinomycin sodium biomass) as 
follows:
    (1) To 046573 in Sec.  510.600(c) of this chapter for use as in 
paragraph (d) of this section.
    (2) To 057926 for use as in paragraphs (d)(1)(i), (d)(1)(iii) 
through (d)(1)(xvi), (d)(2)(i), and (d)(3)(i) of this section.
    (b)-(c) [Reserved]
    (d) Conditions of use. (1) Broilers: It is used as follows:
    (i)(a) Amount per ton. Salinomycin 40 to 60 grams.
    (b) Indications for use. For the prevention of coccidiosis caused by 
Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and 
E. mivati.
    (c) Limitations. Feed continuously as sole ration. Do not feed to 
layers. Not approved for use with pellet binders. May be fatal if 
accidentally fed to adult turkeys or horses.
    (ii)(a) Amount per ton. Salinomycin 40 to 60 grams and roxarsone 
45.4 grams.
    (b) Indications for use. For the prevention of coccidiosis caused by 
Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and 
E. mivati, including some field strains of E. tenella which are more 
susceptible to roxarsone combined with salinomycin than to salinomycin 
alone.
    (c) Limitations. Feed continuously as sole ration. Use as sole 
source of organic arsenic. Not approved for use with pellet binders. Do 
not feed to layers. May be fatal if accidentally fed to adult turkeys or 
horses. Withdraw 5 days before slaughter. Roxarsone as provided by No. 
011526 or 046573 in Sec.  510.600(c) of this chapter.
    (iii)(a) Amount per ton. Salinomycin 40 to 60 grams and bacitracin 
methylene disalicylate 4 to 30 grams.
    (b) Indications for use. For the prevention of coccidiosis caused by 
Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and 
E. mivati for incresed rate of weight gain and improved feed efficiency.
    (c) Limitation. Feed continuously as sole ration. Not approved for 
use with pellet binders. Do not feed to layers. May be fatal if 
accidentially fed to adult turkeys or horses. Bacitracin

[[Page 464]]

methylene disalicylate as provided by No. 046573 in Sec.  510.600(c) of 
this chapter.
    (iv)(a) Amount per ton. Salinomycin 40 to 60 grams with roxarsone 
45.4 grams and bacitracin methylene disalicylate 4 to 50 grams.
    (b) Indications for use. For the prevention of coccidiosis caused by 
Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and 
E. mivati, including some field strains of E. tenella which are more 
susceptible to roxarsone combined with salinomycin than to salinomycin 
alone; for increased rate of weight gain.
    (c) Limitations. Feed continuously as sole ration. Use as sole 
source of organic arsenic. Not approved for use with pellet binders. Do 
not feed to layers. May be fatal if accidentally fed to adult turkeys or 
horses. Withdraw 5 days before slaughter. Roxarsone and bacitracin as 
provided by No. 046573 in Sec.  510.600(c) of this chapter.
    (v)(a) Amount per ton. Salinomycin 40 to 60 grams per ton with 
roxarsone 22.7 to 45.4 grams per ton.
    (b) Indications for use. For the prevention of coccidiosis caused by 
Eimera tenella, E. necatrix, E. acervulina, E. brunetti, E. mivati, and 
E. maxima and for improved feed efficiency.
    (c) Limitations. Feed continuously as sole ration. Use as sole 
source of organic arsenic. Not approved for use with pellet binders. Do 
not feed to layers. May be fatal if accidently fed to adult turkeys or 
to horses. Withdraw 5 days before slaughter. Roxarsone as provided by 
No. 046573 in Sec.  510.600(c) of this chapter.
    (vi)(a) Amount per ton. Salinomycin 40 to 60 grams and bacitracin 
methylene disalicylate 4 to 50 grams.
    (b) Indications for use. For the prevention of coccidiosis caused by 
Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and 
E. mivati, and for improved feed efficiency.
    (c) Limitations. Feed continuously as sole ration. Not approved for 
use with pellet binders. Do not feed to layers. May be fatal if 
accidentally fed to adult turkeys or horses. Bacitracin MD as provided 
by No. 046573 in Sec.  510.600(c) of this chapter.
    (vii)(a) Amount per ton. Salinomycin 40 to 60 grams and bacitracin 
zinc 10 to 50 grams.
    (b) Indications for use. For the prevention of coccidiosis caused by 
Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and 
E. mivati, and for increased rate of weight gain.
    (c) Limitations. Feed continuously as sole ration. Not approved for 
use with pellet binders. Do not feed to layers. May be fatal if 
accidentally fed to adult turkeys or horses. Bacitracin zinc as provided 
by No. 046573 in Sec.  510.600(c) of this chapter.
    (viii)(a) Amount per ton. Salinomycin 40 to 60 grams with roxarsone 
45.4 grams and bacitracin zinc 4 to 50 grams.
    (b) Indications for use. For the prevention of coccidiosis caused by 
Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and 
E. mivati, including some field strains of E. tenella which are more 
susceptible to roxarsone combined with salinomycin than to salinomycin 
alone; for increased rate of weight gain and improved feed efficiency.
    (c) Limitations. See paragraph (d)(1)(iv)(c) of this section.
    (ix)(a) Amount per ton. Salinomycin 40 to 60 grams with roxarsone 
34.1 grams and bacitracin zinc 10 to 50 grams.
    (b) Indications for use. For the prevention of coccidiosis caused by 
Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and 
E. mivati, and for increased rate of weight gain and improved feed 
efficiency.
    (c) Limitations. Feed continuously as sole ration. Use as sole 
source of organic arsenic. Do not feed to layers. May be fatal if 
accidentally fed to adult turkeys or horses. Withdraw 5 days before 
slaughter. Roxarsone as provided by No. 046573 and bacitracin as 
provided by No. 046573 in Sec.  510.600(c) of this chapter.
    (x)(a) Amount per ton. Salinomycin 40 to 60 grams and virginiamycin 
5 grams.
    (b) Indications for use. For the prevention of coccidiosis caused by 
Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and 
E. mivati, and for increased rate of weight gain and improved feed 
efficiency.
    (c) Limitations. Feed continuously as sole ration. Not approved for 
use with pellet binders. Do not feed to layers or to chickens over 16 
weeks of age. May

[[Page 465]]

be fatal if accidentally fed to adult turkeys or horses. Virginiamycin 
as provided by No. 066104 in Sec.  510.600(c) of this chapter.
    (xi)(a) Amount per ton. Salinomycin 40 to 60 grams and virginiamycin 
5 to 15 grams.
    (b) Indications for use. For the prevention of coccidiosis caused by 
Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and 
E. mivati, and for increased rate of weight gain.
    (c) Limitations. See paragraph (d)(1)(x)(c) of this section.
    (xii) (a) Amount per ton. Salinomycin 40 to 60 grams, virginiamycin 
5 grams, and roxarsone 45.4 grams.
    (b) Indications for use. For prevention of coccidiosis caused by 
Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and 
E. mivati, including some field strains of E. tenella which are more 
susceptible to roxarsone combined with salinomycin than to salinomycin 
alone, and for improved feed efficiency.
    (c) Limitations. Feed continuously as sole ration. Withdraw 5 days 
prior to slaughter. Use as sole source of organic arsenic. Not approved 
for use with pellet binders. Do not feed to layers. May be fatal if 
accidentally fed to adult turkeys or horses. Virginiamycin as provided 
by No. 066104 in Sec.  510.600(c) of this chapter. Roxarsone as provided 
by No. 046573 in Sec.  510.600(c) of this chapter.
    (xiii)(a) Amount per ton. Salinomycin 40 to 60 grams and lincomycin 
2 to 4 grams.
    (b) Indications for use. For the prevention of coccidiosis caused by 
Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and 
E. mivati and for improved feed efficiency.
    (c) Limitations. Feed continuously as sole ration. Not approved for 
use with pellet binders. Do not feed to layers. Do not allow horses, 
adult turkeys, guinea pigs, rabbits, hamsters, or ruminants access to 
this feed. Ingestion by these species may result in severe 
gastrointestinal effects or may be fatal. Lincomycin hydrochloride 
monohydrate as provided by No. 000009 in Sec.  510.600(c) of this 
chapter.
    (xiv)(a) Amount per ton. Salinomycin 40 to 60 grams, roxarsone 45.4 
grams, and lincomycin 2 grams.
    (b) Indications for use. For the prevention of coccidiosis caused by 
Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and 
E. mivati, including some field strains of E. tenella that are more 
susceptible to roxarsone combined with salinomycin than to salinomycin 
alone, and for improved feed efficiency.
    (c) Limitations. Feed continuously as sole ration. Not approved for 
use with pellet binders. Drug overdose or lack of water may result in 
leg weakness. Do not feed to layers. Do not allow horses, adult turkeys, 
guinea pigs, rabbits, hamsters, or ruminants access to this feed. 
Ingestion by these species may result in severe gastrointestinal effects 
or may be fatal. Withdraw 5 days before slaughter. Lincomycin 
hydrochloride monohydrate as provided by No. 000009 in Sec.  510.600(c) 
of this chapter. Roxarsone as provided by No. 046573 in Sec.  510.600(c) 
of this chapter.
    (xv)(a) Amount per ton. Salinomycin 40 to 60 grams, 
chlortetracycline 500 grams, and roxarsone 45.4 grams.
    (b) Indications for use. For prevention of coccidiosis caused by 
Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and 
E. mivati, including some field strains of E. tenella which are more 
susceptible to roxarsone combined with salinomycin than to salinomycin 
alone, and as an aid in the reduction of mortality due to E. coli 
infections susceptible to such treatment.
    (c) Limitations. Do not feed to layers. In feeds containing 0.8 
percent dietary calcium, not to be fed for more than 5 days. Not 
approved for use with pellet binders. Withdraw 5 days before slaughter. 
May be fatal if accidentally fed to adult turkeys or to horses. 
Chlortetracycline as provided by Nos. 046573 and 046573; roxarsone as 
provided by No. 046573; and salinomycin as provided by Nos. 046573 and 
057926 in Sec.  510.600(c) of this chapter.
    (xvi)(a) Amount per ton. Salinomycin 40 to 60 grams and 
chlortetracycline 500 grams.
    (b) Indications for use. For the prevention of coccidiosis caused by 
Eimeria tenella, E., necatrix, E. acervulina, E. maxima, E. brunetti, 
and E. mivati, and as an aid in the reduction of mortality due to E. 
coli infections susceptible to such treatment.

[[Page 466]]

    (c) Limitations. Do not feed to layers. In feeds containing 0.8 
percent dietary calcium. Not to be fed for more than 5 days. Not 
approved for use with pellet binders. Withdraw 24 hours before 
slaughter. May be fatal if accidentally fed to adult turkeys or horses. 
Chlortetracycline as provided by Nos. 046573 and 046573; salinomycin as 
provided by Nos. 046573 and 057926 in Sec.  510.600(c) of this chapter.
    (xvii)(A) Amount per ton. Salinomycin 40 to 60 grams with roxarsone 
34.1 or 45.4 grams and bacitracin methylene disalicylate 4 to 50 grams.
    (B) Indications for use. For the prevention of coccidiosis caused by 
Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and 
E. mivati, including some field strains of E. tenella that are more 
susceptible to roxarsone combined with salinomycin than to salinomycin 
alone; for increased rate of weight gain. Use of 34.1 or 45.4 grams per 
ton roxarsone is indicated to meet the E. tenella challenge which varies 
with environmental and management conditions.
    (C) Limitations. Feed continuously as sole ration. Use as sole 
source of organic arsenic. Not approved for use with pellet binders. Do 
not feed to laying chickens. May be fatal if accidentally fed to adult 
turkeys or horses. Poultry should have access to drinking water at all 
times. Overdosage or lack of water may result in leg weakness or 
paralysis. Withdraw 5 days before slaughter. Salinomycin as provided by 
No. 046573 in Sec.  510.600(c) of this chapter. Roxarsone and bacitracin 
as provided by No. 046573 in Sec.  510.600(c) of this chapter.
    (xviii)(A) Amount per ton. Salinomycin, 40 to 60 grams; bacitracin 
methylene disalicylate, 50 grams; and roxarsone, 22.7 to 45.4 grams.
    (B) Indications for use. For the prevention of coccidiosis caused by 
E. tenella, E. necatrix, E. acervulina, E. brunetti, E. mivati, and E. 
maxima, as an aid in the prevention of necrotic enteritis caused or 
complicated by Clostridium spp. or other organisms susceptible to 
bacitracin, for increased rate of weight gain, improved feed efficiency, 
and improved pigmentation.
    (C) Limitations. Feed continuously as sole ration. Do not feed to 
laying chickens. Use as sole source of organic arsenic. Poultry should 
have access to drinking water at all times. Drug overdosage or lack of 
water intake may result in leg weakness or paralysis. May be fatal if 
fed to adult turkeys or to horses. Withdraw 5 days before slaughter. 
Salinomycin as provided by Nos. 046573; bacitracin methylene 
disalicylate and roxarsone as provided by No. 046573 in Sec.  510.600(c) 
of this chapter.
    (xix)(A) Amount per ton. Salinomycin, 40 to 60 grams; bacitracin 
methylene disalicylate, 100 to 200 grams; and roxarsone, 22.7 to 45.4 
grams.
    (B) Indications for use. For the prevention of coccidiosis caused by 
E. tenella, E. necatrix, E. acervulina, E. brunetti, E. mivati, and E. 
maxima, as an aid in the control of necrotic enteritis caused or 
complicated by Clostridium spp. or other organisms susceptible to 
bacitracin, for increased rate of weight gain, improved feed efficiency, 
and improved pigmentation.
    (C) Limitations. Feed continuously as sole ration. To control 
necrotic enteritis, start medication at first clinical signs of disease; 
vary dosage based on the severity of infection; administer continuously 
for 5 to 7 days or as long as clinical signs persist, then reduce 
bacitracin to prevention level (50 g/ton). Do not feed to laying 
chickens. Use as sole source of organic arsenic. Poultry should have 
access to drinking water at all times. Drug overdosage or lack of water 
intake may result in leg weakness or paralysis. May be fatal if fed to 
adult turkeys or to horses. Withdraw 5 days before slaughter. 
Salinomycin as provided by No. 046573; bacitracin methylene disalicylate 
and roxarsone as provided by No. 046573 in Sec.  510.600(c) of this 
chapter.
    (xx)(A) Amount per ton. Salinomycin, 40 to 60 grams; and bacitracin 
methylene disalicylate, 50 grams.
    (B) Indications for use. For the prevention of coccidiosis caused by 
Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and 
E. mivati, and as an aid in the prevention of necrotic enteritis caused 
or complicated by Clostridium spp. or other organisms susceptible to 
bacitracin.
    (C) Limitations. Feed continuously as sole ration. Do not feed to 
laying chickens. May be fatal if fed to adult

[[Page 467]]

turkeys or to horses. Salinomycin as provided by 046573; bacitracin 
methylene disalicylate as provided by 046573 in Sec.  510.600(c) in this 
chapter.
    (xxi)(A) Amount per ton. Salinomycin, 40 to 60 grams; and bacitracin 
methylene disalicylate, 100 to 200 grams.
    (B) Indications for use. For the prevention of coccidiosis caused by 
Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and 
E. mivati, and as an aid in the control of necrotic enteritis caused or 
complicated by Clostridium spp. or other organisms susceptible to 
bacitracin.
    (C) Limitations. Feed continuously as sole ration. To control 
necrotic enteritis, start medication at first clinical signs of disease; 
vary dosage based on the severity of infection; administer continuously 
for 5 to 7 days or as long as clinical 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 046573; bacitracin methylene disalicylate as provided by 
046573 in Sec.  510.600(c) in this chapter.
    (xxii) Amount per ton. Salinomycin, 40 to 60 grams; plus tylosin, 4 
to 50 grams.
    (A) Indications for use. As an aid in the prevention of coccidiosis 
caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. 
brunetti, and E. mivati, and for increased rate of weight gain and 
improved feed efficiency.
    (B) Limitations. For broiler chickens only. Feed continuously as 
sole ration. Do not feed to laying hens. Not approved for use with 
pellet binders. May be fatal if accidentally fed to adult turkeys or 
horses. Salinomycin as provided by 046573; tylosin phosphate as provided 
by 000986 in Sec.  510.600(c) of this chapter.
    (2) Quail--(i)(a) Amount per ton. Salinomycin 50 grams.
    (b) Indications for use. For the prevention of coccidiosis caused by 
E. dispersa and E. lettyae.
    (c) Limitations. Feed continuously as sole ration. Not approved for 
use with pellet binders. May be fatal if accidentally fed to adult 
turkeys or horses.
    (ii) [Reserved]
    (3) Roaster and replacement (breeder and layer) chickens: It is used 
as follows:
    (i)(A) Amount per ton. Salinomycin 40 to 60 grams.
    (B) Indications for use. For prevention of coccidiosis caused by 
Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and 
E. mivati.
    (C) Limitations. Feed continuously as sole ration. Do not feed to 
laying hens producing eggs for human consumption. Not approved for use 
with pellet binders. May be fatal if accidentally fed to horses or adult 
turkeys.
    (ii) Amount per ton. Salinomycin, 40 to 60 grams, and bacitracin 
methylene disalicylate, 4 to 50 grams.
    (A) Indications for use. For the prevention of coccidiosis caused by 
Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and 
E. mivati, and for increased rate of weight gain and improved feed 
efficiency.
    (B) Limitations. Feed continuously as sole ration. Discontinue use 
prior to sexual maturity. Do not feed to laying chickens. May be fatal 
if fed to adult turkeys or to horses. Salinomycin as provided by 046573; 
bacitracin methylene disalicylate as provided by 046573 in Sec.  
510.600(c) of this chapter.
    (iii) Amount per ton. Salinomycin, 40 to 60 grams, and bacitracin 
methylene disalicylate, 50 grams.
    (A) Indications for use. For the prevention of coccidiosis caused by 
Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and 
E. mivati, and as an aid in the prevention of necrotic enteritis caused 
or complicated by Clostridium spp. or other organisms susceptible to 
bacitracin.
    (B) Limitations. Feed continuously as sole ration. Discontinue use 
prior to sexual maturity. Do not feed to laying chickens. May be fatal 
if fed to adult turkeys or to horses. Salinomycin as provided by 046573; 
bacitracin methylene disalicylate as provided by 046573 in Sec.  
510.600(c) of this chapter.
    (iv)(A) Amount per ton. Salinomycin, 40 to 60 grams; bacitracin 
methylene disalicylate, 50 grams; and roxarsone, 22.7 to 45.4 grams.
    (B) Indications for use. For the prevention of coccidiosis caused by 
E. tenella, E. necatrix, E. acervulina, E. brunetti, E. mivati, and E. 
maxima, as an

[[Page 468]]

aid in the prevention of necrotic enteritis caused or complicated by 
Clostridium spp. or other organisms susceptible to bacitracin, for 
increased rate of weight gain, improved feed efficiency, and improved 
pigmentation.
    (C) Limitations. Feed continuously as sole ration. Discontinue use 
prior to sexual maturity. Do not feed to laying chickens. Use as sole 
source of organic arsenic. Poultry should have access to drinking water 
at all times. Drug overdosage or lack of water intake may result in leg 
weakness or paralysis. May be fatal if fed to adult turkeys or to 
horses. Withdraw 5 days before slaughter. Salinomycin as provided by No. 
046573; bacitracin methylene disalicylate and roxarsone as provided by 
No. 046573 in Sec.  510.600(c).
    (v) Amount per ton. Salinomycin, 40 to 60 grams, and bacitracin 
methylene disalicylate, 100 to 200 grams.
    (A) Indications for use. For the prevention of coccidiosis caused by 
Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and 
E. mivati, and as an aid in the control of necrotic enteritis caused or 
complicated by Clostridium spp. or other organisms susceptible to 
bacitracin.
    (B) Limitations. Feed continuously as sole ration. To control 
necrotic enteritis, start medication at first clinical signs of disease; 
vary dosage based on the severity of infection; administer continuously 
for 5 to 7 days or as long as clinical signs persist, then reduce 
bacitracin to prevention level (50 grams per ton). Discontinue use prior 
to sexual maturity. Do not feed to laying chickens. May be fatal if fed 
to adult turkeys or to horses. Salinomycin as provided by 046573; 
bacitracin methylene disalicylate as provided by 046573 in Sec.  
510.600(c) of this chapter.
    (vi)(A) Amount per ton. Salinomycin, 40 to 60 grams; bacitracin 
methylene disalicylate, 100 to 200 grams; and roxarsone, 22.7 to 45.4 
grams.
    (B) Indications for use. For the prevention of coccidiosis caused by 
E. tenella, E. necatrix, E. acervulina, E. brunetti, E. mivati, and E. 
maxima, as an aid in the control of necrotic enteritis caused or 
complicated by Clostridium spp. or other organisms susceptible to 
bacitracin, for increased rate of weight gain, improved feed efficiency, 
and improved pigmentation.
    (C) Limitations. Feed continuously as sole ration. To control 
necrotic enteritis, start medication at first clinical signs of disease; 
vary dosage based on the severity of infection; administer continuously 
for 5 to 7 days or as long as clinical signs persist, then reduce 
bacitracin to prevention level (50 g/ton). Discontinue use prior to 
sexual maturity. Do not feed to laying chickens. Use as sole source of 
organic arsenic. Poultry should have access to drinking water at all 
times. Drug overdosage or lack of water intake may result in leg 
weakness or paralysis. May be fatal if fed to adult turkeys or to 
horses. Withdraw 5 days before slaughter. Salinomycin as provided by No. 
046573; bacitracin methylene disalicylate and roxarsone as provided by 
No. 046573 in Sec.  510.600(c).
    (vii) Amount per ton. Salinomycin, 40 to 60 grams; and roxarsone, 
22.7 to 45.4 grams.
    (A) Indications for use. For the prevention of coccidiosis caused by 
Eimeria tenella,E. necatrix,E. acervulina,E. brunetti,E. mivati, andE. 
maxima, and for increased rate of weight gain, improved feed efficiency, 
and improved pigmentation.
    (B) Limitations. Feed continuously as sole ration. Discontinue use 
prior to sexual maturity. Do not feed to laying chickens. Use as sole 
source of organic arsenic. Poultry should have access to drinking water 
at all times. Drug overdosage or lack of water intake may result in leg 
weakness or paralysis. May be fatal if fed to adult turkeys or to 
horses. Withdraw 5 days before slaughter. Salinomycin as provided by No. 
046573 and roxarsone as provided by No. 046573 in Sec.  510.600(c) of 
this chapter.
    (4) Permitted combinations. Salinomycin may be used as in this 
section in combinations as follows:
    (i) Bambermycins and roxarsone as in Sec.  558.95.
    (ii) Bambermycins as in Sec.  558.95.
    (iii) Oxytetracycline as in Sec.  558.450.

[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 
Finding Aids section of the printed volume and on GPO Access.

[[Page 469]]



Sec.  558.555  Semduramicin.

    (a) Specifications. Type A medicated article containing 22.7 grams 
per pound (50 grams per kilogram) semduramicin sodium.
    (b) Approvals. See No. 066104 in Sec.  510.600(c) of this chapter 
for use as in paragraph (d) of this section.
    (c) Related tolerances. See Sec.  556.597 of this chapter.
    (d) Conditions of use in broiler chickens. (1)(i) Amount. 
Semduramicin: 25 parts per million.
    (ii) Indications for use. For the prevention of coccidiosis caused 
by Eimeria tenella, E. acervulina, E. maxima, E. brunetti, E. necatrix, 
and E. mivati/E. mitis.
    (iii) Limitations. Do not feed to laying hens.
    (2) Amount. Semduramicin 22.7 grams with bacitracin methylene 
disalicylate 10 to 50 grams and roxarsone 45.4 grams per ton.
    (i) Indications for use. For the prevention of coccidiosis caused by 
Eimeria acervulina, E. brunetti, E. maxima, E. mivati/E. mitis, E. 
necatrix, and E. tenella, including some field strains of E. tenella 
that are more susceptible to semduramicin combined with roxarsone than 
semduramicin alone, and for improved feed efficiency.
    (ii) Limitations. Feed continuously as sole ration. Use feed within 
2 weeks of production. Withdraw 5 days before slaughter. Do not feed to 
laying hens. Use as sole source of organic arsenic. Poultry should have 
access to drinking water at all times. Drug overdosage or lack of water 
intake may result in leg weakness or paralysis. Semduramicin as provided 
by 066104 in Sec.  510.600(c) of this chapter, bacitracin methylene 
disalicylate and roxarsone as provided by 046573.
    (3) Amount. Semduramicin 22.7 grams with bacitracin methylene 
disalicylate 10 to 50 grams per ton.
    (i) Indications for use. For the prevention of coccidiosis caused by 
Eimeria acervulina, E. brunetti, E. maxima, E. mivati/E. mitis, E. 
necatrix, and E. tenella, and for improved feed efficiency in broiler 
chickens.
    (ii) Limitations. Feed continuously as sole ration. Use feed within 
2 weeks of production. Do not feed to laying hens. Semduramicin as 
provided by 066104, bacitracin methylene disalicylate as provided by 
046573 in Sec.  510.600(c) of this chapter.
    (4) Amount. Semduramicin 22.7 grams with roxarsone 45.4 grams per 
ton.
    (i) Indications for use. For the prevention of coccidiosis caused by 
Eimeria acervulina, E. brunetti, E. maxima, E. mivati/E. mitis, E. 
necatrix, and E. tenella, including some field strains of E. tenella 
that are more susceptible to semduramicin combined with roxarsone than 
semduramicin alone.
    (ii) Limitations. Feed continuously as sole ration. Withdraw 5 days 
before slaughter. For broiler chickens only. Do not feed to laying hens. 
Use as sole source of organic arsenic. Roxarsone as provided by 046573, 
semduramicin as provided by 066104 in Sec.  510.600(c) of this chapter.
    (5) Amount. Semduramicin 22.7 grams with virginiamycin 20 grams per 
ton.
    (i) Indications for use. For the prevention of coccidiosis caused by 
Eimeria tenella, E. acervulina, E. maxima, E. brunetti, E. necatrix, and 
E. mivati/mitis, and for prevention of necrotic enteritis caused by 
Clostridium perfringens susceptible to virginiamycin.
    (ii) Limitations. For broiler chickens only. Feed continuously as 
sole ration. Do not feed to laying hens. Semduramicin and virginiamycin 
as provided by 066104 in Sec.  510.600(c) of this chapter.
    (6) Amount. Semduramicin 22.7 grams with virginiamycin 5 to 15 grams 
per ton.
    (i) Indications for use. For the prevention of coccidiosis caused by 
Eimeria tenella, E. acervulina, E. maxima, E. brunetti, E. necatrix, and 
E. mivati/mitis, and for increased rate of weight gain.
    (ii) Limitations. For broiler chickens only. Feed continuously as 
sole ration. Do not feed to laying hens. Semduramicin and virginiamycin 
as provided by 066104 in Sec.  510.600(c) of this chapter.
    (7) Amount. Semduramicin 22.7 grams with virginiamycin 5 grams per 
ton.
    (i) Indications for use. For the prevention of coccidiosis caused by 
Eimeria tenella, E. acervulina, E. maxima, E. brunetti, E. necatrix, and 
E. mivati/mitis, and for increased rate of weight gain and improved feed 
efficiency.

[[Page 470]]

    (ii) Limitations. For broiler chickens only. Feed continuously as 
sole ration. Do not feed to laying hens. Semduramicin and virginiamycin 
as provided by 066104 in Sec.  510.600(c) of this chapter.

[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]



Sec.  558.575  Sulfadimethoxine, ormetoprim.

    (a) Approvals. Type A medicated articles to sponsors as identified 
in Sec.  510.600(c) of this chapter for uses as in paragraph (d) of this 
section as follows:
    (1) 25 percent sufadimethoxine and 15 percent ormetoprim to 046573 
for use for poultry as in paragraphs (d)(1), (d)(2), (d)(3), (d)(4), and 
(d)(7) of this section.
    (2) 25 percent sulfadimethoxine and 5 percent ormetoprim to 046573 
for use for fish as in paragraphs (d)(5) and (d)(6) of this section.
    (b) Related tolerances. See Sec. Sec.  556.490 and 556.640 of this 
chapter.
    (c) [Reserved]
    (d) Conditions of use. It is used in feeds for animals as follows:
    (1) Broiler chickens--(i) Amount per ton. Sulfadimethoxine, 113.5 
grams (0.0125 percent) plus ormetoprim, 68.1 grams (0.0075 percent).
    (a) Indications for use. As an aid in the prevention of coccidiosis 
caused 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 H. gallinarum (infectious 
coryza), E. coli (colibacillosis) and P. multocida (fowl cholera).
    (b) Limitations. Feed as sole ration; withdraw 5 days before 
slaughter.
    (ii) Amount per ton. Sulfadimethoxine, 113.5 grams (0.0125 percent) 
plus ormetoprim, 68.1 grams (0.0075 percent) plus roxarsone, 22.7 grams 
(0.0025 percent).
    (a) Indications for use. As an aid in the prevention of coccidiosis 
caused 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 H. gallinarum (infectious 
coryza), E. coli, (colibacillosis); and P. multocida (fowl cholera); 
growth promotion and feed efficiency; improving pigmentation.
    (b) Limitations. Withdraw 5 days before slaughter; as sole source of 
organic arsenic.
    (2) Replacement chickens--(i) Amount per ton. Sulfadimethoxine, 
113.5 grams (0.0125 percent) plus ormetoprim, 68.1 grams (0.0075 
percent).
    (ii) Indications for use. As an aid in the prevention of coccidiosis 
caused 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 H. galmaxima, and bacterial 
infections due to H. gallinarum (infectious coryza), E. coli 
(colibacillosis) and P. multocida (fowl cholera).
    (iii) Limitations. Feed as a sole ration; do not feed to chickens 
over 16 weeks (112 days) of age; withdraw 5 days before slaughter.
    (3) Turkeys--(i) Amount per ton. Sulfadimethoxine, 56.75 grams 
(0.00625 percent) plus ormetoprim, 34.05 grams (0.00375 percent).
    (ii) Indications for use. As an aid in the prevention of coccidiosis 
caused by all Eimeria species known to be pathogenic to turkeys, namely, 
E. adenoeides, E. gallopavonis, and E. meleagrimitis and bacterial 
infection due to P. multocida (fowl cholera).
    (iii) Limitations. Do not feed to turkeys producing eggs for food; 
withdraw 5 days before slaughter.
    (4) Ducks--(i) Amount per ton. Sulfadimethoxine, 227 grams (0.025 
percent) plus ormetoprim, 136.2 grams (0.015 percent).
    (a) Indications for use. As an aid in the control of bacterial 
infections due to P. multocida (fowl cholera) in ducks, including 
breeding ducks.
    (b) Limitations. Feed as sole ration for 7 days; withdraw 5 days 
before slaughter; medication should be started at the first signs of 
infection; do not feed to ducks producing eggs for food.
    (ii) Amount per ton. Sulfadimethoxine, 454 grams (0.05 percent) plus 
ormetoprim, 272.4 grams (0.03 percent).
    (a) Indications for use. As an aid in the control of bacterial 
infections due

[[Page 471]]

to E. coli, Riemerella anatipestifer, and severe challenge of P. 
multocida (fowl cholera) in ducks.
    (b) Limitations. Feed as a sole ration for 7 days; withdraw 5 days 
before slaughter; medication should be started at the first signs of 
infection; not for breeding ducks; do not feed to ducks producing eggs 
for food.
    (5) Salmonids--(i) Amount. 50 milligrams of active ingredients per 
kilogram of body weight per day.
    (ii) Indications of use. For the control of furunculosis in 
salmonids (trout and salmon) caused by Aeromonas salmonicida strains 
susceptible to sulfadimethoxine and ormetoprim combination.
    (iii) Limitations. Administer for 5 consecutive days; withdraw 42 
days before release as stocker fish or slaughter.
    (6) Catfish--(i) Amount. 50 milligrams of active ingredients per 
kilogram of body weight per day.
    (ii) Indications for use. For control of enteric septicemia of 
catfish caused by Edwardsiella ictaluri strains susceptible to 
sulfadimethoxine and ormetoprim combination.
    (iii) Limitations. Administer for 5 consecutive days; withdraw 3 
days before slaughter or release as stocker fish.
    (7) Chukar partridges--(i) Amount per ton. Sulfadimethoxine 113.5 
grams (0.0125 percent) plus ormetoprim 68.1 grams (0.0075 percent).
    (ii) Indications for use. For prevention of coccidiosis caused by 
Eimeria kofoidi and E. legionensis.
    (iii) Limitations. Feed continuously to young birds up to 8 weeks of 
age as sole ration.

[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]



Sec.  558.579  Sulfaethoxypyridazine.

    (a) Approvals. Type A medicated articles: 5.5 percent for swine, and 
5.5 and 11 percent for cattle to 010042 in Sec.  510.600(c) of this 
chapter.
    (b) Related tolerances. See Sec.  556.650 of this chapter.
    (c) Conditions of use. It is used in animal feed as follows:
    (1) Swine--(i) Amount. 25 milligrams per pound body weight per day.
    (ii) Indications for use. For treatment of bacterial scours, 
pneumonia, enteritis, bronchitis, septicemia accompanying Salmonella 
choleraesuis infection.
    (iii) Limitations. Administer 1,000 grams per ton (0.11 percent) for 
not less than 4 days nor more than 10 days; do not treat within 10 days 
of slaughter; as sole source of sulfonamide; for use by or on the order 
of a licensed veterinarian.
    (2) Cattle--(i) Amount. 25 milligrams per pound body weight per day.
    (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. Administer as a top dressing or in mixed feed for 
4 days; do not treat within 16 days of slaughter; as sole source of 
sulfonamide; 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; for use by or on the order of a licensed veterinarian.

[41 FR 11005, Mar. 15, 1976, as amended at 51 FR 7400, Mar. 3, 1986; 52 
FR 2686, Jan. 26, 1987]



Sec.  558.582  Sulfamerazine.

    (a) Approvals. Type A medicated articles: 99 percent to 046573 in 
Sec.  510.600(c) of this chapter.
    (b) Related tolerances. See Sec.  556.660 of this chapter.
    (c) Conditions of use. It is used in fish feed for rainbow trout, 
brook trout, and brown trout as follows:
    (1) Amount. 10 grams of sulfamerazine per 100 pounds of fish per 
day.
    (2) Indications for use. Control of furunculosis.
    (3) Limitations. Treat for not more than 14 days; do not treat 
within 3 weeks of marketing or stocking in stream open to fishing.

[41 FR 11005, Mar. 15, 1976, as amended at 51 FR 7400, Mar. 3, 1986; 61 
FR 18082, Apr. 24, 1996; 63 FR 27846, May 21, 1998; 66 FR 46707, Sept. 
7, 2001]



Sec.  558.586  Sulfaquinoxoline.

    (a) Approvals. Type A medicated articles: 40 percent to 050749 in 
Sec.  510.600(c) of this chapter.

[[Page 472]]

    (b)-(c) [Reserved]
    (d) NAS/NRC status. The conditions of use specified in this section 
have been reviewed by NAS/NRC and are found effective. Applications for 
these uses need not include effectiveness data as specified by Sec.  
514.111 of this chapter, but may require bioequivalency information. 
Applications must be accompanied by a written commitment to undertake 
the human safety studies required by FDA.
    (e) Special considerations. (1) For control of outbreaks of disease, 
medication should be initiated as soon as the diagnosis is determined. 
Medicated chickens, turkeys, and rabbits must actually consume enough 
medicated feed which provides a recommended dose of approximately 3.5 to 
60 milligrams per pound per day in chickens, 2.5 to 100 milligrams per 
pound per day in turkeys, and 2.8 to 68 milligrams per pound per day in 
rabbits depending upon age and class of animal, ambient temperature, and 
other factors. Consult a veterinarian or poultry pathologist for 
diagnosis.
    (2) [Reserved]
    (f) Conditions of use. It is used as follows:
    (1) Chickens--(i) Amount. 0.015 percent.
    (a) Indications for use. As an aid in preventing outbreaks of 
coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. 
maxima, and E. brunetti under average conditions of exposure.
    (b) Limitations. Feed continuously from the time birds are placed on 
litter and continue past the age when coccidiosis is ordinarily a 
hazard. If death losses exceed 0.5 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) Amount. 0.0175 percent.
    (a) Indications for use. As an aid in preventing outbreaks of 
coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. 
maxima, and E. brunetti where excessive exposure to coccidia is 
increased due to overcrowding or other management factors.
    (b) Limitations. Feed continuously from the time birds are placed on 
litter and continue past the age when coccidiosis is ordinarily a 
hazard. If death losses exceed 0.5 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.
    (iii) Amount. 0.1 to 0.05 percent.
    (a) Indications for use. As an aid in controlling outbreaks of 
coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. 
maxima, and E. brunetti.
    (b) Limitations. Feed at 0.1 percent level for first 48 to 72 hours. 
Skip 3 days; 0.05 percent for 2 days, skip 3 days; 0.05 percent for 2 
days. If bloody 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.
    (2) Turkeys--(i) Amount. 0.0175 percent.
    (a) Indications for use. As an aid in preventing outbreaks of 
coccidiosis caused by Eimeria meleagrimitis and E. adenoeides.
    (b) Limitations. Feed 0.0175 percent continuously during time birds 
are closely confined. May be continued for week to 10 days 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) Amount. 0.05 percent.

[[Page 473]]

    (a) Indications for use. As an aid in controlling outbreaks of 
coccidiosis caused by Eimeria meleagrimitis, and E. adenoeides.
    (b) Limitations. Feed 0.05 percent for 2 days. Follow with 3 days on 
regular feed and 2 more days on 0.05 percent sulfaquinoxaline feed. 
Again follow with 3 days on regular feed and 2 more days on 0.05 percent 
sulfaquinoxaline feed. Continue this schedule if necessary till 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.
    (3) Chickens and turkeys--(i) Amount. 0.05 or 0.1 percent.
    (a) Indications for use. 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.
    (b) Limitations. Feed 0.1 percent for 48 to 72 hours. Mortality 
should be brought under control. After medication, move birds to clean 
ground or to a clean house. If disease recurs, use 0.05 percent in feed 
again for 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.
    (ii) [Reserved]
    (4) Rabbits--(i) Amount. 0.025 percent.
    (a) Indications for use. As an aid in preventing coccidiosis caused 
by Eimeria stiedae.
    (b) Limitations. Treatment to be started after weaning. Feed 
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) Amount. 0.1 percent.
    (a) Indications for use. As an aid in controlling outbreaks of 
coccidiosis caused by Eimeria stiedae.
    (b) Limitations. Feed for 2 weeks. Do not treat within 10 days of 
slaughter.

[48 FR 3965, Jan. 28, 1983, as amended at 51 FR 7400, Mar. 3, 1986; 52 
FR 2686, Jan. 26, 1987; 55 FR 29843, July 23, 1990; 59 FR 33197, June 
28, 1994]



Sec.  558.600  Tiamulin.

    (a) Specifications. Type A article containing 5, 10, or 113.4 grams 
of tiamulin (as tiamulin hydrogen fumarate) per pound.
    (b) Approvals. See No. 000010 in Sec.  510.600(c) of this chapter.
    (c) Related tolerances. See Sec.  556.738 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) Not for use in swine weighing over 250 pounds.
    (3) Use as sole source of tiamulin.
    (e) Conditions of use--(1) Swine. It is used as follows:

----------------------------------------------------------------------------------------------------------------
                                    Combination in      Indications for
    Tiamulin in grams per ton        grams per ton            use             Limitations           Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 10..........................  ..................  For increased rate  Feed continuously   000010
                                                       of weight gain      as the sole
                                                       and improved feed   ration.
                                                       efficiency.
(ii) 35.........................  ..................  1. For control of   Feed continuously   000010
                                                       swine dysentery     as sole ration on
                                                       associated with     premises with a
                                                       Brachyspira         history of swine
                                                       (formerly           dysentery but
                                                       Serpulina or        where signs of
                                                       Treponema)          disease have not
                                                       hyodysenteriae      yet occurred or
                                                       susceptible to      following
                                                       tiamulin.           approved
                                                                           treatment of
                                                                           disease. Withdraw
                                                                           2 days before
                                                                           slaughter.
                                  ..................  2. For control of   Feed continuously   000010
                                                       porcine             as the sole
                                                       proliferative       ration for not
                                                       enteropathies       less than 10
                                                       (ileitis)           days. Withdraw 2
                                                       associated with     days before
                                                       Lawsonia            slaughter.
                                                       intracellularis.

[[Page 474]]

 
(iii) 35........................  Chlortetracycline,  For treatment of    Feed continuously   000010
                                   approximately 400   swine bacterial     as sole ration
                                   (varying with       enteritis caused    for 14 days. Use
                                   body weight and     by Escherichia      as only source of
                                   feed consumption    coli and            chlortetracycline
                                   to provide 10       Salmonella          . Withdraw 2 days
                                   milligrams of       choleraesuis and    before slaughter.
                                   chlortetracycline   bacterial          As
                                   per pound of body   pneumonia caused    chlortetracycline
                                   weight daily).      by Pasteurella      calcium complex,
                                                       multocida           Type A medicated
                                                       susceptible to      articles
                                                       chlortetracycline   containing the
                                                       , and control of    equivalent of 50
                                                       swine dysentery     to 100 grams per
                                                       associated with     pound of
                                                       Brachyspira         chlortetracycline
                                                       (formerly           hydrochloride
                                                       Serpulina or        provided by
                                                       Treponema)          046573 and 053389
                                                       hyodysenteriae      in Sec.
                                                       susceptible to      510.600(c) of
                                                       tiamulin.           this chapter.
(iv) 200........................  ..................  For treatment of    Feed continuously   000010
                                                       swine dysentery     as the sole feed
                                                       associated with     for 14
                                                       Brachyspira         consecutive days.
                                                       (formerly           Withdraw feed 7
                                                       Serpulina or        days before
                                                       Treponema)          slaughter.
                                                       hyodysenteriae
                                                       susceptible to
                                                       tiamulin.
----------------------------------------------------------------------------------------------------------------

    (2) [Reserved]

[67 FR 7268, Feb. 19, 2002]



Sec.  558.615  Thiabendazole.

    (a) Approvals. Dry Type A medicated articles: 22, 44.1, 66.1, and 
88.2 percent to 050604 in Sec.  510.600(c) of this chapter. The 66.1 
percent Type A is solely for the manufacture of cane molasses liquid 
Type B feed which is mixed in dry feeds. The 88.2 percent Type A is used 
solely for the manufacture of an aqueous slurry for adding to a Type C 
dry cattle feed.
    (b) Special considerations. Do not use in Type B or Type C medicated 
feed containing bentonite.
    (c) Related tolerances. See Sec.  556.730 of this chapter.
    (d) Conditions of use. It is used in feed for animals as follows:
    (1) Cattle--(i) Amount. 3 grams per 100 lb. body weight.
    (a) Indications for use. Control of infections of gastrointestinal 
roundworms (Trichostrongylus spp., Haemonchus spp., Ostertagia spp., 
Nematodirus spp., Oesophagostomum radiatum).
    (b) Limitations. Use 3 grams per 100 lb. body weight at a single 
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 lb. body weight.
    (a) Indications for use. Control of severe infections of 
gastrointestinal roundworms (Trichostrongylus spp., Haemonchus spp., 
Ostertagia spp., Nematodirus spp., Oesophagostomum radiatum); control of 
infections of Cooperia spp.
    (b) Limitations. 5 grams per 100 lb. body weight at a single dose or 
divided into 3 equal doses, administered 1 dose each day, on succeeding 
days; 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) Goats--(i) Amount. 3 grams per 100 lb. 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. 3 grams per 100 lb. body weight at a single 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.
    (3) Sheep and goats--(i) Amount. 2 grams per 100 lb. body weight.
    (ii) Indications for use. Control of infections of gastrointestinal 
roundworms (Trichostrongylus spp., Haemonchus spp., Ostertagia spp.,

[[Page 475]]

Cooperia spp.; Nematodirus spp., Bunostomum spp., Strongyloides spp., 
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.).
    (iii) Limitations. Use 2 grams per 100 lb. body weight at a single 
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.
    (4) For swine--(i) Amount. 45.4-908 grams per ton (0.005-0.1 
percent).
    (ii) Indications for use. Aid in the prevention of infections of 
large roundworms (genus Ascaris).
    (iii) Limitations. Administer continuously feed containing 0.05-0.1 
percent thiabendazole per ton for 2 weeks followed by feed containing 
0.005-0.02 percent thiabendazole per ton for 8-14 weeks; do not treat 
animals within 30 days of slaughter.
    (5) Pheasants--(i) Amount. 454 grams per ton (0.05 percent) 
continuously for 2 weeks (14 days).
    (ii) Indications for use. For the treatment of gapeworms (Syngamus 
trachea) in pheasants.
    (iii) Limitations. Do not use 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.

[40 FR 13959, Mar. 27, 1975, as amended at 47 FR 49641, Nov. 2, 1982; 49 
FR 29958, July 25, 1984; 51 FR 7400, Mar. 3, 1986; 52 FR 2686, Jan. 26, 
1987; 62 FR 63271, Nov. 28, 1997]



Sec.  558.618  Tilmicosin.

    (a) Specifications. Type A medicated article containing 20 percent 
tilmicosin as tilmicosin phosphate (90.7 grams per pound).
    (b) Approvals. See No. 000986 in Sec.  510.600(c) of this chapter.
    (c) Special considerations. (1) Federal law limits this drug to use 
under the professional supervision of a licensed veterinarian. See Sec.  
558.6 of this chapter for additional requirements for the use of 
products regulated as veterinary feed directives (VFDs).
    (2) The expiration date of VFDs for tilmicosin must not exceed 90 
days from the time of issuance. VFDs for tilmicosin shall not be 
refilled.
    (3) Do not use in Type B or Type C medicated feeds containing 
bentonite.
    (d) Related tolerances. See Sec.  556.735 of this chapter.
    (e) Conditions of use. It is used in swine feed as follows:
    (1) Amount per ton. 181 grams to 363 grams tilmicosin.
    (2) Indications for use. For the control of swine respiratory 
disease associated with Actinobacillus pleuropneumoniae and Pasteurella 
multocida.
    (3) Limitations. Feed continuously as the sole ration for 21-day 
period, beginning approximately 7 days before an expected disease 
outbreak. 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. The safety of tilmicosin has not been 
established in pregnant swine or swine intended for breeding purposes. 
Do not allow horses or other equines access to feeds containing 
tilmicosin. Withdraw 7 days before slaughter.

[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]



Sec.  558.625  Tylosin.

    (a) Specifications. Tylosin is the antibiotic substance produced by 
growth of Streptomyces fradiae or the same antibiotic substance produced 
by any other means. Tylosin, present as the phosphate salt, conforms to 
the appropriate antibiotic standard. Tylosin contains at least 95 
percent tylosin as a combination of tylosin A, tylosin B, tylosin C, and 
tylosin D of which at least 80 percent is tylosin A as determined by a 
method entitled ``Determination of Factor Content in Tylosin by High 
Performance Liquid Chromatography,'' which is incorporated by reference. 
Copies are available from the Dockets Management Branch (HFA-305), Food

[[Page 476]]

and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 
20852, or available for inspection at the Office of the Federal 
Register, 800 North Capitol Street, NW., suite 700, Washington, DC 
20001.
    (b) Approvals. Type A medicated article levels of tylosin granted to 
firms as sponsor(s) and identified by drug listing numbers in Sec.  
510.600(c) of this chapter for the specific usage indicated in paragraph 
(f) of this section.
    (1) To 000986: 10, 40, 100 grams per pound, paragraphs (f)(1) (i) 
through (vi) of this section.
    (2) [Reserved]
    (3) To 043733: 20 and 40 grams per pound, paragraphs (f)(1)(i) 
through (vi) of this section.
    (4) [Reserved]
    (5) To 017800: 0.4, 0.8, 1, and 8 grams per pound, paragraph 
(f)(1)(vi)(a) of this section; 10 and 40 grams per pound, paragraphs 
(f)(1) (i) through (vi) of this section.
    (6)-(7) [Reserved]
    (8) To 035369: 4 and 10 grams per pound, paragraph (f)(1)(vi)(a) of 
this section; 10 grams per pound, paragraphs (f)(1) (i) through (vi) of 
this section.
    (9) [Reserved]
    (10) To 017519: 0.4, 0.8, and 1.6 grams per pound, paragraph 
(f)(1)(vi)(a) of this section; 20, 40, and 100 grams per pound, 
paragraphs (f)(1)(i) through (f)(1)(vi) of this section.
    (11) [Reserved]
    (12) To 021930: 2 grams per pound, paragraph (f)(1)(vi)(a) of this 
section; 5, 10, 20, and 40 grams per pound, paragraphs (f)(1) (i) 
through (vi) of this section.
    (13) [Reserved]
    (14) To 016968: 1, 2, 4, 8, and 10 grams per pound, paragraphs 
(f)(1) (i), (iii), (iv), and (vi) of this section; 20, 25, 40, and 100 
grams per pound, paragraphs (f)(1) (i) through (vi) of this section.
    (15)-(21) [Reserved]
    (22) To 026282: 10 grams per pound; paragraph (f)(1)(vi)(a) of this 
section.
    (23)-(24) [Reserved]
    (25) To 066104: 4, 8, and 10 grams per pound, paragraph 
(f)(1)(vi)(a) of this section; 20 and 40 grams per pound, paragraphs 
(f)(1) (i) through (vi) of this section.
    (26)-(30) [Reserved]
    (31) To 029341: 5 grams per pound; paragraph (f)(1)(vi)(a) of this 
section.
    (32) [Reserved]
    (33) To 034936: 0.8 and 2 grams per pound, paragraph (f)(1)(vi)(a) 
of this section; 4, 8, and 10 grams per pound, paragraphs (f)(1)(i), 
(iii), (iv), and (vi) of this section; 40 grams per pound, paragraphs 
(f)(1) (i) through (vi) of this section; 100 grams per pound, paragraphs 
(f)(1) (i), (ii), (iii), (iv), and (vi) of this section.
    (34) [Reserved]
    (35) To 039741: 2 and 10 grams per pound, paragraph (f)(1)(vi)(a) of 
this section.
    (36)-(37) [Reserved]
    (38) To 053740: 1 gram per pound, paragraph (f)(1)(vi)(a) of this 
section; 5, 10, 20, and 40 grams per pound, paragraphs (f)(1) (i) 
through (vi) of this section.
    (39) To 061623: 10 grams per pound, paragraph (f)(1)(vi)(a) of this 
section.
    (40) To 035955: 10 grams per pound, paragraph (f)(1)(vi)(a) of this 
section.
    (41) [Reserved]
    (42) To 010439: 0.4, 0.5, and 2 grams per pound, paragraph 
(f)(1)(vi) (a) of this section; 5, 10, 20, and 40 grams per pound, 
paragraph (f)(1)(i) through (vi) of this section.
    (43)-(44) [Reserved]
    (45) To 017139: 4 and 10 grams per pound, paragraph (f)(1)(vi)(a) of 
this section.
    (46)-(47) [Reserved]
    (48) To 017790: 5, 10, 20, and 40 grams per pound, paragraphs (f)(1) 
(i) through (vi) of this section.
    (49)-(51) [Reserved]
    (52) To 017519: 5, 10, 20, and 40 grams per pound, paragraphs (f)(1) 
(i) through (vi) of this section.
    (53) [Reserved]
    (54) To 046573: 5, 10, 20, and 40 grams per pound, paragraphs (f)(1) 
(i) through (vi) of this section.
    (55)-(56) [Reserved]
    (57) To 028459: 0.4 and 10 grams per pound; paragraph (f)(1)(vi)(a) 
of this section.
    (58)-(62) [Reserved]
    (63) To 046987: 5, 10, 20, and 40 grams per pound, paragraphs (f)(1) 
(i) through (vi) of this section.
    (64)-(65) [Reserved]
    (66) To 024174: 5, 10, 20, and 40 grams per pound, paragraphs (f)(1) 
(i) through (vi) of this section.

[[Page 477]]

    (67) To 027190: 2 grams per pound; paragraph (f)(1)(vi)(a) of this 
section.
    (68) To 017473: 10 and 40 grams per pound, paragraphs (f)(1) (i) 
through (vi) of this section.
    (69)-(76) [Reserved]
    (77) To 050639: 5, 10, 20, and 40 grams per pound, paragraphs (f)(1) 
(i) through (vi) of this section.
    (78) To 050972: 0.36, 0.4, 0.72, and 0.8 gram per pound, paragraph 
(f)(1)(vi)(a) of this section; 1 gram per pound, paragraphs (f)(1)(vi) 
(a), (b), and (d) of this section.
    (79) To 017519: 5, 10, 20, and 40 grams per pound, paragraphs (f)(1) 
(i) through (vi) of this section.
    (80) To 049685: 5, 10, 20, and 40 grams per pound, paragraphs (f)(1) 
(i) through (vi) of this section.
    (81)-(82) [Reserved]
    (83) To 046573: 5-, 10-, 20-, and 40-grams per pound, paragraphs 
(f)(1) (i) through (vi) of this section.
    (84) [Reserved]
    (85) To 047126: 10, 40, and 100 grams per pound, paragraphs (f)(1) 
(i) through (vi) of this section.
    (86)-(88) [Reserved]
    (89) To 053389: 5, 10, 20, and 40 grams per pound, paragraph (f)(1) 
(i) through (vi) of this section.
    (c) Special considerations. (1) 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 Type B feeds stored in recirculating tank systems: 
Recirculate immediately prior to use for no fewer 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 Type B feeds stored in mechanical, air, or other 
agitation-type tank systems: Agitate immediately prior to use for no 
fewer 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) Tylosin liquid Type B medicated feeds used to make Type C 
medicated feeds for cattle may be manufactured from tylosin Type A 
medicated articles according to the following mixing directions:
    (i) Presolubilize tylosin in 50 percent urea for approximately 1 
hour prior to adding any feed components or other active ingredients.
    (ii) Maintain a pH between 4.5 and 6.0.
    (3) Tylosin liquid Type B medicated feeds must bear an expiration 
date of 8 weeks after the date of manufacture.
    (d) [Reserved]
    (e) Related tolerances. See Sec.  556.740 of this chapter.
    (f) Conditions of use. (1) It is used in animal feeds as follows:
    (i) For beef cattle--(a) Amount per ton. 8-10 grams.
    (b) Indications for use. For reduction of incidence of liver 
abscesses caused by Fusobacterium necrophorum and Actinomyces 
(Corynebacterium) pyogenes.
    (c) Limitations. As tylosin phosphate; each animal must receive not 
more than 90 milligrams per day and not less than 60 milligrams per day; 
feed continuously as sole ration.
    (ii) Broiler chickens--(a) Amount per ton. Tylosin, 800-1000 grams.
    (b) Indications for use. To aid in the control of chronic 
respiratory disease caused by Mycoplasma gallisepticum.
    (c) Limitations. As tylosin phosphate; withdraw 5 days before 
slaughter; administer in feed to chickens 0 to 5 days of age, follow 
with second administration in feed for 24-48 hours at 3 to 5 weeks of 
age.
    (iii) Chickens--(a) Amount per ton. Tylosin, 4-50 grams.
    (1) Indications for use. For increased rate of weight gain and 
improved feed efficiency.
    (2) Limitations. As tylosin phosphate.
    (iv) Laying chickens--(a) Amount per ton. Tylosin, 20-50 grams.
    (b) Indications for use. For improved feed efficiency.
    (c) Limitations. As tylosin phosphate.
    (v) Replacement chickens--(a) Amount per ton. Tylosin, 1,000 grams.
    (b) Indications for use. To aid in the control of chronic 
respiratory disease caused by Mycoplasma gallisepticum.
    (c) Limitations. As tylosin phosphate; withdraw 5 days before 
slaughter; administer in feed to chickens 0 to 5 days

[[Page 478]]

of age, follow with second administration in feed for 24 to 48 hours at 
3 to 5 weeks of age.
    (vi) Swine--(a) Amount per ton. Tylosin, 10-100 grams.
    (1) Indications for use. For increased rate of weight gain and 
improved feed efficiency.
    (2) Limitations. As tylosin phosphate; continuous use as follows: 
Grams per ton: 20-100, prestarter or starter; 20-40, grower; 10-20, 
finisher.
    (b) Amount per ton. Tylosin, 40-100 grams.
    (1) Indications for use. Prevention of swine dysentery (vibrionic).
    (2) Limitations. Use 100 grams per ton for at least 3 weeks followed 
by 40 grams per ton until market weight; as tylosin phosphate.
    (c) Amount per ton. Tylosin, 40-100 grams.
    (1) Indications for use. Treatment and control of swine dysentery 
(vibrionic).
    (2) Limitations. Administer in feed as tylosin phosphate after 
treatment with tylosin in drinking water as tylosin base; 0.25 gram per 
gallon in drinking water for 3-10 days, 40-100 grams per ton in feed for 
2-6 weeks.
    (d) Amount per ton. Tylosin, 100 grams.
    (1) Indications for use. Maintaining weight gains and feed 
efficiency in presence of atrophic rhinitis.
    (2) Limitations. As tylosin phosphate.
    (vi) Pyrantel tartrate in accordance with Sec.  558.485.
    (e) Amount per ton. Tylosin 100 grams. (1) Indications for use. 
Prevention and/or control of procine proliferative enteropathies 
(ileitis) associated with Lawsonia intracellularis.
    (2) Limitations. As tylosin phosphate, administer for 21 days.
    (2) Tylosin may also be used in combination with:
    (i) Decoquinate and monensin as in Sec.  558.195.
    (ii) Hygromycin B as in Sec.  558.274.
    (iii) Melengestrol acetate alone or in combination with certain 
ionophores as in Sec.  558.342.
    (iv) Monensin as in Sec.  558.355.
    (v) Narasin as in Sec.  558.363.
    (vi) Pyrantel tartrate as in Sec.  558.485.
    (vii) Ractopamine hydrochloride as in Sec.  558.500.
    (viii) Salinomycin as in Sec.  558.550.

[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 on GPO Access.



Sec.  558.630  Tylosin and sulfamethazine.

    (a) [Reserved]
    (b) Approvals. Type A medicated article levels, a combination of 
equal amounts of tylosin and sulfamethazine, granted to firms as 
sponsor(s) and identified by drug listing numbers in Sec.  510.600(c) of 
this chapter for the conditions of use indicated in paragraph (f) of 
this section.
    (1) To 000986: 40 grams per pound each, paragraph (f)(2)(i).
    (2) To 000986: 10 grams per pound each, paragraph (f)(2)(i).
    (3) To 017519: 10 grams per pound each, paragraph (f)(2)(ii) of this 
section.
    (4) [Reserved]
    (5) To 017800: 40 grams per pound each, paragraph (f)(2)(ii) of this 
section.
    (6) To 017139: 4, 10, or 20 grams per pound each, paragraph 
(f)(2)(ii) of this section.
    (7) To 021930: 2 grams per pound each, paragraph (f)(2)(i) of this 
section; 5, 10, 20, or 40 grams per pound each, paragraph (f)(2)(ii) of 
this section.
    (8) To 017519: 5 or 10 grams per pound each, paragraph (f)(2)(ii) of 
this section.
    (9) [Reserved]
    (10) To 010439, 011749, 016968, 017473, 017519, 017790, 024174, 
030841, 034936, 035098, 043733, 046573, 046987, 050568, 050639, 051359, 
and 053389: 5, 10, 20, or 40 grams per pound each, paragraph (f)(2)(ii) 
of this section.
    (c)-(d) [Reserved]
    (e) Related tolerances. See Sec. Sec.  556.670 and 556.740 of this 
chapter.
    (f) Conditions of use. It is used in feed for swine as follows:
    (1) Amount per ton. Tylosin, 100 grams plus sulfamethazine, 100 
grams.
    (2) Indications for use. (i) Maintaining weight gains and feed 
efficiency in the presence of atrophic rhinitis; lowering the incidence 
and severity of Bordetella bronchiseptica rhinitis; prevention of swine 
dysentery (vibrionic); control of

[[Page 479]]

swine pneumonias caused by bacterial pathogens (P. multocida and/or C. 
pyogenes); for 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.
    (ii) Maintaining weight gains and feed efficiency in the presence of 
atrophic rhinitis; lowering the incidence and severity of Bordetella 
bronchiseptica rhinitis; prevention of swine dysentery (vibrionic); 
control of swine pneumonias caused by bacterial pathogens (Pasteurella 
multocida and/or Corynebacterium pyogenes).
    (3) Limitations. As tylosin phosphate; withdraw 15 days before 
slaughter.

[40 FR 13959, Mar. 27, 1975]

    Editorial Note: For Federal Register citations affecting Sec.  
558.630, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and on GPO Access.



Sec.  558.635  Virginiamycin.

    (a) Approvals. Type A medicated articles. (1) 1.1 percent activity 
(5 grams per pound), 2.2 percent activity (10 grams per pound), 4.4 
percent activity (20 grams per pound), 11 percent activity (50 grams per 
pound), and 50 percent activity (227 grams per pound) used as in 
paragraph (d) of this section; and 30 percent activity (136.2 grams per 
pound) for the manufacture of Type C medicated feed for cattle used as 
in paragraph (d)(3); to 066104 in Sec.  510.600(c) of this chapter.
    (2) 2.2 percent activity (10 grams per pound) to 046573, 016968, and 
017790 in Sec.  510.600(c) of this chapter for use as in paragraphs 
(d)(1)(iv) and (d)(1)(v) of this section.
    (b) Related tolerances. See Sec.  556.750 of this chapter.
    (c) Special considerations. (1) Not for use in breeding swine over 
120 pounds.
    (2) Dilute Type A article with at least 10 pounds of a feed 
ingredient prior to final mixing in 1 ton of Type C feed.
    (d) Conditions of use--(1) Swine. It is used as follows:
    (i) 100 grams per ton for 2 weeks, for treatment of swine dysentery 
in nonbreeding swine over 120 pounds.
    (ii) 100 grams per ton for 2 weeks, 50 grams per ton thereafter, for 
treatment and control of swine dysentery in swine up to 120 pounds.
    (iii) 25 grams per ton, as an aid in control of dysentery in swine 
up to 120 pounds. For use in animals or on premises with a history of 
swine dysentery but where symptoms have not yet occurred.
    (iv) 10 grams per ton from weaning up to 120 pounds for increased 
rate of weight gain and improved feed efficiency, followed by 5 grams 
per ton to market weight for increased rate of weight gain and improved 
feed efficiency. For continuous use from weaning to market weight.
    (v) 10 grams per ton from weaning up to 120 pounds for increased 
rate of weight gain and improved feed efficiency, followed by 5 to 10 
grams per ton to market weight for increased rate of weight gain. For 
continuous use from weaning to market weight.
    (2) Poultry. It is used as follows:
    (i) 5 to 15 grams per ton for increased rate of weight gain, for use 
in broiler chickens, not for use in layers.
    (ii) 5 grams per ton for increased rate of weight gain and improved 
feed efficiency in broiler chickens, not for use in layers.
    (iii) 20 grams per ton for prevention of necrotic enteritis caused 
by Clostridium perfringens susceptible to virginiamycin in broiler 
chickens; not for use in layers.
    (iv) 10 to 20 grams per ton for increased rate of weight gain and 
improved feed efficiency in growing turkeys.
    (3) Cattle. It is used as follows:
    (i) 16.0 to 22.5 grams per ton to provide 100 to 340 milligrams per 
head per day for increased rate of weight gain.
    (ii) 13.5 to 16.0 grams per ton to provide 85 to 240 milligrams per 
head per day for reduction of incidence of liver abscesses.
    (iii) 11.0 to 16.0 grams per ton to provide 70 to 240 milligrams per 
head per day for improved feed efficiency.
    (iv) Feed continuously as sole ration to cattle fed in confinement 
for slaughter. Not for use in animals intended for breeding.
    (4) Virginiamycin may be used in combination with:

[[Page 480]]

    (i) Amprolium and ethopabate as in Sec.  558.58.
    (ii) Diclazuril as in Sec.  558.198.
    (iii) Halofuginone as in Sec.  558.265.
    (iv) Lasalocid as in Sec.  558.311.
    (v) Monensin alone or with roxarsone as in Sec.  558.355.
    (vi) Salinomycin alone or with roxarsone as in Sec.  558.550.
    (vii) Semduramicin as in Sec.  558.555.

[40 FR 13959, Mar. 27, 1975]

    Editorial Note: For Federal Register citations affecting Sec.  
558.635, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and on GPO Access.



Sec.  558.680  Zoalene.

    (a) Specifications. Type A medicated article containing 25 percent 
zoalene.
    (b) Approvals. See No. 046573 in Sec.  510.600(c) of this chapter.
    (c) Related tolerances. See Sec.  556.770 of this chapter.
    (d) Conditions of use--(1) Chickens and turkeys:

------------------------------------------------------------------------
   Zoalene in     Combination in    Indications for
   grams/ton        grams/ton             use             Limitations
------------------------------------------------------------------------
(i) 36.3-113.5   ...............  Replacement         Grower ration not
 (0.004-                           chickens;           to be fed to
 0.0125%).                         development of      birds over 14
                                   active immunity     weeks of age; as
                                   to coccidiosis.     follows:
------------------------------------------------------------------------


 
                                                --------------------------
                                                 Growing conditions          Starter ration       Grower ration
                                                                              Grams per ton       Grams per ton
 
                                                --------------------------
                                                 Severe exposure            113.5 (0.0125%)          75.4-113.5
                                                                                              (0.0083%-0.0125%)
                                                 Light to moderate               75.4-113.5   36.3-75.4 (0.004%-
                                                  exposure                (0.0083%-0.0125%)            0.0083%)
                                                --------------------------
 


------------------------------------------------------------------------
   Zoalene in     Combination in    Indications for
   grams/ton        grams/ton             use             Limitations
------------------------------------------------------------------------
                 Arsanilate       Replacement         Grower ration not
                  sodium 90        chickens;           to be fed to
                  (0.01%).         development of      birds over 14
                                   active immunity     weeks of age;
                                   to coccidiosis;     withdraw 5 days
                                   growth promotion    (d) before
                                   and feed            slaughter; as
                                   efficiency;         sole source of
                                   improving           organic arsenic;
                                   pigmentation.       feed as in
                                                       subtable in item
                                                       (i).
                 Arsanilic acid   Replacement         Grower ration not
                  90 (0.01%).      chickens;           to be fed to
                                   development of      birds over 14
                                   active immunity     weeks of age;
                                   to coccidiosis;     withdraw 5 d
                                   growth promotion    before slaughter;
                                   and feed            as sole source of
                                   efficiency;         organic arsenic;
                                   improving           feed as in
                                   pigmentation.       subtable in item
                                                       (i).
                 Arsanilic acid   Replacement         As erythromycin
                  90 (0.01%)       chickens; growth    thiocyanate;
                  plus             promotion and       grower ration not
                  erythromycin     feed                to be fed to
                  4.6 to 18.5.     efficiency;develo   birds over 14
                                   pment of active     weeks of age;
                                   immunity to         withdraw 5 d
                                   coccidiosis;        before slaughter;
                                   improving           as sole source of
                                   pigmentation.       organic arsenic;
                                                       feed as in
                                                       subtable item
                                                       (i).
                 Arsanilic acid   1. Replacement      Feed for 2 d
                  90 (0.01%)       chickens; as an     before stress and
                  plus             aid in the          3 to 6 d after
                  erythromycin     prevention of       stress; as
                  92.5.            chronic             erythromycin
                                   respiratory         thiocyanate;
                                   disease during      grower ration not
                                   periods of          to be fed to
                                   stress;             birds over 14
                                   development of      weeks of age;
                                   active immunity     withdraw 5 d
                                   to coccidiosis;     before slaughter;
                                   growth promotion    as sole source of
                                   and feed            organic arsenic
                                   efficiency;         arsenic; feed as
                                   improving           in subtable in
                                   pigmentation.       item (i).
                 ...............  2. Replacement      Feed for 7 to 14
                                   chickens; as an     d; as
                                   aid in the          erythromycin
                                   prevention of       thiocyanate;
                                   infectious          grower ration not
                                   coryza;             to be fed to
                                   development of      birds over 14
                                   active immunity     weeks of age;
                                   to coccidiosis;     withdraw 5 d
                                   growth promotion    before slaughter;
                                   and                 as sole source of
                                   feedefficiency;     organic arsenic;
                                   improving           feed as in
                                   pigmentation.       subtable in item
                                                       (i).

[[Page 481]]

 
                 Arsanilic acid   Replacement         Feed for 5 to 8 d;
                  90 (0.01%)       chickens; as an     do not use in
                  plus             aid in the          birds producing
                  erythromycin     prevention and      eggs for food
                  185.             reduction of        purposes;
                                   lesions and in      withdraw 5 d
                                   lowering severity   before slaughter;
                                   of chronic          as erythromycin
                                   respiratory         thiocyanate; as
                                   disease; growth     sole source of
                                   promotion and       organic arsenic;
                                   feed efficiency;    feed as in
                                   improving           subtable in item
                                   pigmentation and    (i).
                                   development of
                                   active immunity
                                   to coccidiosis.
                 Arsanilic acid   Replacement         As procaine
                  90 (0.01%)       chickens; growth    penicillin;
                  plus             promotion and       grower ration not
                  penicillin 2.4   feed                to be fed to
                  to 50.           efficiency;develo   birds over 14
                                   pment of active     weeks of age;
                                   immunity to         withdraw 5 d
                                   coccidiosis;        before slaughter;
                                   improving           as sole source of
                                   pigmentation.       organic arsenic;
                                                       feed as in
                                                       subtable in item
                                                       (i).
                 Bacitracin       Replacement         Feed continuously
                  methylene        chickens;           as sole ration as
                  disalicylate     development of      in subtable in
                  50               active immunity     this item (i);
                                   to coccidiosis;     grower ration not
                                   as an aid in the    to be fed to
                                   prevention of       birds over 14
                                   necrotic            weeks of age.
                                   enteritis caused    Bacitracin
                                   or complicated by   methylene
                                   Clostridium spp.    disalicylate as
                                   or other            provided by
                                   organisms           046573 in Sec.
                                   susceptible to      510.600(c) of
                                   bacitracin.         this chapter.
                 Bacitracin       Replacement         Feed continuously
                  methylene        chickens;           as sole ration as
                  disalicylate     development of      in subtable in
                  100 to 200       active immunity     this item (i). To
                                   to coccidiosis;     control necrotic
                                   as an aid in the    enteritis, start
                                   control of          medication at
                                   necrotic            first clinical
                                   enteritis caused    signs of disease;
                                   or complicated by   vary bacitracin
                                   Clostridium spp.    dosage based on
                                   or other            the severity of
                                   organisms           infection;
                                   susceptible to      administer
                                   bacitracin.         continuously for
                                                       5 to 7 days or as
                                                       long as clinical
                                                       signs persist,
                                                       then reduce
                                                       bacitracin to
                                                       prevention level
                                                       (50 grams/ton).
                                                       Bacitracin
                                                       methylene
                                                       disalicylate as
                                                       provided by
                                                       046573 in Sec.
                                                       510.600(c) of
                                                       this chapter.
                 Bacitracin 100   Replacement         As bacitracin
                  to 500.          chickens;           zinc; grower
                                   treatment of        ration not to be
                                   chronic             fed to birds over
                                   respiratorydiseas   14 weeks of age;
                                   e (air-sac          feed as in
                                   infection); blue    subtable in item
                                   comb (nonspecific   (i).
                                   infectious
                                   enteritis);
                                   development of
                                   active immunity
                                   to coccidiosis.
 
                 Chlortetracycli  Replacement         Do not feed to
                  ne 100 to 200.   chickens;           chickens
                                   development of      producing eggs
                                   active immunity     for human
                                   to coccidiosis;     consumption;
                                   control of          grower ration not
                                   infectious          to be fed to
                                   synovitis caused    birds over 14
                                   by Mycoplasma       weeks of age;
                                   synoviae            feed as in
                                   susceptible to      subtable in item
                                   chlortetracycline   (i).
                                   .
                 Chlortetracycli  Replacement         Do not feed to
                  ne 200 to 400.   chickens;           chickens
                                   development of      producing eggs
                                   active immunity     for human
                                   to coccidiosis;     consumption;
                                   control of          grower ration not
                                   chronic             to be fed to
                                   respiratory         birds over 14
                                   disease (CRD) and   weeks of age;
                                   air sac infection   feed as in
                                   caused by M.        subtable in item
                                   gallisepticum and   (i).
                                   Escherichia coli
                                   susceptible to
                                   chlortetracycline
                                   .
                 Erythromycin     Replacement         As erythromycin
                  4.6 to 18.5.     chickens; growth    thiocyanate;
                                   promotion and       grower ration not
                                   feed efficiency;    to be fed to
                                   development of      birds over 14
                                   active immunity     weeks of age;
                                   to coccidiosis.     feed as in
                                                       subtable in item
                                                       (i).
                 Erythromycin     1. Replacement      Feed for 2 d
                  92.5.            chickens, as an     before stress and
                                   aid in the          3 to 6 after
                                   prevention of       stress; withdraw
                                   chronic             24 hours (h)
                                   respiratory         before slaughter;
                                   disease during      as erythromycin
                                   periods of          thiocyanate;
                                   stress;             grower ration not
                                   development of      to be fed to
                                   active immunity     birds over 14
                                   to coccidiosis.     weeks of age;
                                                       feed as in
                                                       subtable in item
                                                       (i).

[[Page 482]]

 
                 ...............  2. Replacement      Feed for 7 to 14
                                   chickens; as an     d; withdraw 24 h
                                   aid in the          before slaughter;
                                   prevention of       as erythromycin
                                   infectious          thiocyanate;
                                   coryza;             grower ration not
                                   development of      to be fed to
                                   active immunity     birds over 14
                                   to coccidiosis.     weeks of age;
                                                       feed as in
                                                       subtable in item
                                                       (i).
                 Erythromycin     Replacement         Feed for 5 to 8 d;
                  185.             chickens; as an     do not use in
                                   aid in the          birds producing
                                   prevention and      eggs for food
                                   reduction of        purposes;
                                   lesions and in      withdraw 48 h
                                   lowering severity   before slaughter;
                                   of chronic          grower ration not
                                   respiratory         to be fed to
                                   disease;            birds over 14
                                   development of      weeks of age;
                                   active immunity     feed as in
                                   to coccidiosis.     subtable in item
                                                       (i).
                 Hygromycin B 8   Replacement         Grower ration not
                  to 12.           chickens;           to be fed to
                                   development of      birds over 14
                                   active immunity     weeks of age;
                                   to coccidiosis;     feed as in
                                   control of          subtable in item
                                   infestation of      (i).
                                   large round worms
                                   (Ascaris galli)
                                   cecal worms
                                   (Heterakis
                                   gallinae) and
                                   capillary worms
                                   (Capillaria
                                   obsignate).
                 Penicillin 2.4   Replacement         As procaine
                  to 50.           chickens; growth    penicillin;
                                   promotion and       grower ration not
                                   feed efficiency;    to be fed to
                                   development of      birds over 14
                                   active immunity     weeks of age;
                                   to coccidiosis.     feed as in
                                                       subtable in item
                                                       (i).
                 Penicillin 2.4   Replacement         As procaine
                  to 50 plus       chickens; growth    penicillin;
                  roxarsone 22.7   promotion and       grower ration not
                  to 45.4          feed efficiency;    to be fed to
                  (0.0025% to      development of      birds over 14
                  0.005%).         active immunity     weeks of age;
                                   to coccidiosis;     withdraw 5 d
                                   improving           before slaughter;
                                   pigmentation.       as sole source of
                                                       organic arsenic;
                                                       feed as in
                                                       subtable in item
                                                       (i).
                 Roxarsone 22.7   Replacement         Grower ration not
                  to 45.5          chickens;           to be fed to
                  (0.0025% to      development of      birds over 14
                  0.005%).         active immunity     weeks of age;
                                   to coccidiosis;     withdraw 5 d
                                   growth promotion    before slaughter;
                                   and feed            as sole source of
                                   efficiency;         organic arsenic;
                                   improving           feed as in
                                   pigmentation.       subtable in item
                                                       (i).
(ii) 113.5       ...............  Broiler chickens;
 (0.0125%).                        prevention and
                                   control of
                                   coccidiosis.
                 Arsanilate       Broiler chickens;   Withdraw 5 d
                  sodium 90        prevention and      before slaughter;
                  (0.01%).         control of          as sole source of
                                   coccidiosis;        organic arsenic.
                                   growth promotion
                                   and feed
                                   efficiency;
                                   improving
                                   pigmentation.
                 Arsanilic acid   Broiler chickens;   Withdraw 5 d
                  90 (0.01%).      growth promotion    before slaughter;
                                   and feed            as sole source of
                                   efficiency;         organic arsenic.
                                   prevention and
                                   control of
                                   coccidiosis;
                                   improving
                                   pigmentation.
                 Arsanilic acid   Broiler chickens;   As erythromycin
                  90 (0.01%)       growth prevention   thiocyanate;
                  plus             and control of      withdraw 5 d
                  erythromycin     coccidiosis;        before slaughter;
                  4.6 to 18.5.     improving           as sole source of
                                   pigmentation.       organic arsenic.
                 Arsanilic acid   1. Broiler           Do.
                  90 (0.01%)       chickens; as an
                  plus             aid in the
                  erythromycin     prevention of
                  92.5.            chronic
                                   respiratory
                                   disease during
                                   periods of
                                   stress; growth
                                   promotion and
                                   feed efficiency;
                                   improving
                                   pigmentation;
                                   control of
                                   coccidiosis.
                 ...............  2. Broiler           Do.
                                   chickens;
                                   prevention and
                                   control of
                                   coccidiosis;
                                   growth promotion
                                   and feed
                                   efficiency;
                                   improving
                                   pigmentation; as
                                   an aid in the
                                   prevention of
                                   infectious
                                   coryza.
                 Arsanilic acid   Broiler chickens;   Feed for 5 to 8 d;
                  90 (0.01%)       as an aid in the    do not use in
                  plus             prevention and      birds producing
                  erythromycin     reduction of        eggs for food
                  185.             lesions and in      purposes; as
                                   lowering severity   erythromycin
                                   of chronic          thiocyanate;
                                   respiratory         withdraw 5 d
                                   disease;            before slaughter;
                                   prevention and      as sole source of
                                   control of          organic arsenic.
                                   coccidiosis;
                                   growth promotion
                                   and feed
                                   efficiency;
                                   improving
                                   pigmentation.

[[Page 483]]

 
                 Arsanilic acid   Broiler chickens;   As procaine
                  90 (0.01%)       growth promotion    penicillin;
                  plus             and feed            withdraw 5 d
                  penicillin 2.4   efficiency;         before slaughter;
                  to 50.           prevention and      as sole source of
                                   control of          organic arsenic.
                                   coccidiosis;
                                   improving
                                   pigmentation.
                 Arsanilic acid   Broiler chickens;   Withdraw 5 d
                  90 (0.01%)       prevention and      before slaughter;
                  plus             control of          as sole source of
                  bacitracin 4     coccidiosis;        organic arsenic;
                  to 50.           improving           as bacitracin
                                   pigmentation;       methylene
                                   growth promotion    disalicylate.
                                   and feed
                                   efficiency.
                 Bacitracin 4 to  Broiler chickens;   As bacitracin
                  50.              growth promotion    methylene
                                   and feed            disalicylate or
                                   efficiency;         zinc bacitracin.
                                   prevention and
                                   control of
                                   coccidiosis.
                 Bacitracin 4 to  Broiler chickens;   As bacitracin
                  50 plus          growth promotion    methylene
                  roxarsone 22.7   and feed            disalicylate or
                  to 45.4          efficiency;         zinc bacitracin;
                  (0.0025 to       prevention and      withdraw 5 d
                  0.005%).         control of          before slaughter;
                                   coccidiosis;        as sole source of
                                   improving           organic arsenic.
                                   pigmentation.
                 Bacitracin       Broiler chickens;   Feed continuously
                  methylene        prevention and      as sole ration.
                  disalicylate     control of          Bacitracin
                  50               coccidiosis; as     methylene
                                   an aid in the       disalicylate as
                                   prevention of       provided by
                                   necrotic            046573 in Sec.
                                   enteritis caused    510.600(c) of
                                   or complicated by   this chapter.
                                   Clostridium spp.
                                   or other
                                   organisms
                                   susceptible to
                                   bacitracin.
                 Bacitracin       Broiler chickens;   Feed continuously
                  methylene        prevention and      as sole ration.
                  disalicylate     control of          To control
                  100 to 200       coccidiosis; as     necrotic
                                   an aid in the       enteritis, start
                                   control of          medication at
                                   necrotic            first clinical
                                   enteritis caused    signs of disease;
                                   or complicated by   vary bacitracin
                                   Clostridium spp.    dosage based on
                                   or other            the severity of
                                   organisms           infection;
                                   susceptible to      administer
                                   bacitracin.         continuously for
                                                       5 to 7 days or as
                                                       long as clinical
                                                       signs persist,
                                                       then reduce
                                                       bacitracin to
                                                       prevention level
                                                       (50 grams/ton).
                                                       Bacitracin
                                                       methylene
                                                       disalicylate as
                                                       provided by
                                                       046573 in Sec.
                                                       510.600(c) of
                                                       this chapter.
                 Bacitracin 100   Broiler chickens;   As zinc bacitrain.
                  to 500.          treatment of
                                   chronic
                                   respiratory
                                   disease (air-sac
                                   infection); blue
                                   comb (nonspecific
                                   infectious
                                   enteritis);
                                   prevention and
                                   control of
                                   coccidiosis.
 
                 Chlortetracycli  Broiler chickens;   Do not feed to
                  ne 100 to 200    prevention and      chickens
                                   control of          producing eggs
                                   coccidiosis;        for human
                                   control of          consumption; feed
                                   infectious          continuously for
                                   synovitis caused    7 to 14 d.
                                   by M. synoviae
                                   susceptible to
                                   chlortetracycline
                                   .
                 Chlortetracycli  Broiler chickens;   Do not feed to
                  ne 200 to 400    prevention and      chickens
                                   control of          producing eggs
                                   coccidiosis;        for human
                                   control of          consumption; feed
                                   chronic             continuously for
                                   respiratory         7 to 14 d.
                                   disease (CRD) and
                                   air sac infection
                                   caused by M.
                                   gallisepticum and
                                   E. coli
                                   susceptible to
                                   chlortetracycline
                                   .
                 Erythromycin     Broiler chickens;   As erythromycin
                  4.6 to 18.5.     growth promotion    thiocyanate.
                                   and feed
                                   efficiency;
                                   prevention and
                                   control of
                                   coccidiosis.
                 Erythromycin     1. Broiler          Feed for 2 d
                  92.5.            chickens; as an     before stress and
                                   aid in the          3 to 6 d after
                                   prevention of       stress; withdraw
                                   chronic             24 h before
                                   respiratory         slaughter; as
                                   disease during      erythromycin
                                   period of stress;   thiocyanate.
                                   prevention and
                                   control of
                                   coccidiosis.
                 ...............  2. Broiler          Feed for 7 to 14
                                   chicken; as an      d; withdraw 24 h
                                   aid in the          before slaughter;
                                   prevention of       as erythromycin
                                   infectious          thiocyanate.
                                   coryza;
                                   prevention and
                                   control of
                                   coccidiosis.

[[Page 484]]

 
                 Erythromycin     Broiler chickens;   Feed for 5 to 8 d;
                  185.             as an aid in the    do not use in
                                   prevention and      birds producing
                                   reduction of        eggs for food
                                   lesions and in      purposes;
                                   lowering severity   withdraw 48 h
                                   of chronic          before slaughter;
                                   respiratory         as erythromycin
                                   disease;            thiocyanate.
                                   prevention and
                                   control of
                                   coccidiosis.
                 Hygromycin B 8   Broiler chickens;   ..................
                  to 12.           prevention and
                                   control of
                                   coccidiosis;
                                   control of
                                   infestation of
                                   large round worms
                                   (Ascaris galli)
                                   cecal worms
                                   (Heterakis
                                   gallinae) and
                                   capillary worms
                                   (Capillaria
                                   obsignate) .
                 Lincomycin 2.    Broiler chickens;   Do not feed to
                                   increase in rate    laying chickens;
                                   of weight gain;     to be fed as the
                                   improved feed       sole ration; as
                                   efficiency; as an   lincomycin
                                   aid in the          hydrochloride
                                   prevention and      monohydrate
                                   control of          provided by No.
                                   coccidiosis.        000009 in Sec.
                                                       510.600(c) of
                                                       this chapter.
                 Penicillin 2.4   Broiler chickens;   As procaine
                  to 50.           growth promotion    penicillin.
                                   and feed
                                   efficiency;
                                   prevention and
                                   control of
                                   coccidiosis.
                 Penicillin 2.4   Broiler chickens;   Withdraw 5 d
                  to 50 plus       prevention and      before slaughter;
                  roxarsone 22.7   control of          as sole source of
                  to 45.4          coccidiosis;        organic arsenic;
                  (0.0025 to       growth promotion    as procaine
                  0.005%).         and feed            penicillin.
                                   efficiency;
                                   improving
                                   pigmentation.
                 Roxarsone 22.7   Broiler chickens;   Withdraw 5 d
                  to 45.4          prevention and      before slaugher;
                  (0.0025 to       control of          as sole source of
                  0.005%).         coccidiosis;        organic arsenic.
                                   growth promotion
                                   and feed
                                   efficiency;
                                   improving
                                   pigmentation.
(iii) 113.5 to   ...............  Turkeys;            For turkeys grown
 170.3 (0.0125                     prevention and      for meat purposes
 to 0.01875%).                     control of          only.
                                   coccidiosis.
                 Arsanilate       Turkeys; growth     For turkeys grown
                  sodium 90        promotion and       for meat purposes
                  (0.01%).         feed efficiency;    only; withdraw 5
                                   improving           d before
                                   pigmentation.       slaughter; as
                                                       sole source of
                                                       organic arsenic.
                 Arsanilic acid    do.                 Do.
                  90(0.01%).
                 Bacitracin       Turkeys;            For turkeys grown
                  methylene        prevention and      for meat purposes
                  disalicylate 4-  control of          only, not to be
                  50.              coccidiosis, and    fed to laying
                                   increased rate of   birds, feed
                                   weight gain and     continuously as
                                   improved feed       sole ration until
                                   efficiency.         14 to 16 weeks of
                                                       age.
                 Carbarsone (not  Turkeys;            For turkeys grown
                  U.S.P.) 277 to   prevention and      for meat purposes
                  340.5 (0.025%    control of          only; feed
                  to 0.0375%).     coccidiosis; aid    continuously
                                   in the prevention   beginning 2 weeks
                                   of blackhead.       before blackhead
                                                       and coccidiosis
                                                       are expected and
                                                       continue as long
                                                       as prevention of
                                                       blackhead and
                                                       prevention and
                                                       control of
                                                       coccidiosis is
                                                       needed; withdraw
                                                       5 d before
                                                       slaughter; as
                                                       sole source of
                                                       organic arsenic.
                 Roxarsone 22.7   Turkeys; growth     Withdraw 5 d
                  to 45.4          promotion and       before slaughter;
                  (0.0025% to      feed efficiency;    as sole source of
                  0.005%).         improving           organic arsenic.
                                   pigmentation.
------------------------------------------------------------------------

    (2) Permitted combinations. It may be used in accordance with the 
provisions of this section in the combinations provided, as follows:
    (i) Bambermycins in accordance with Sec.  558.95.
    (ii) Roxarsone in accordance with Sec.  558.530.

[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]

[[Page 485]]



PART 564 [RESERVED]--Table of Contents






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.

    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.
    (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 in the United States.
    (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 those human, animal, analytical, 
and other scientific studies, whether published or unpublished, 
appropriate to establish the safety of a substance.
    (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 intended conditions of 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

[[Page 486]]

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 determined 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.

[41 FR 38644, Sept. 10, 1976, as amended at 42 FR 55206, Oct. 14, 1977]



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]

[[Page 487]]



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, 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

[[Page 488]]

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.



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

[[Page 489]]

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 about the substance throughout the scientific community 
knowledgeable about the safety of substances directly or indirectly 
added to food.
    (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 regulation for the 
ingredient. General recognition of safety through scientific procedures 
shall ordinarily be based upon published studies which may be 
corroborated by unpublished studies and other data and information.
    (c) General recognition of safety through experience based on common 
use in food prior to January 1, 1958, may be determined without the 
quantity or quality of scientific procedures required for approval of a 
food additive regulation. General recognition of safety through 
experience based on common use in food prior to January 1, 1958, 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.
    (d) The food ingredients listed as GRAS in part 582 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 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.
    (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 an 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

[[Page 490]]

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 and 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]



Sec.  570.35  Affirmation of generally recognized as safe (GRAS) status.

    (a) The Commissioner, either on his initiative or on the petition of 
an interested person, may affirm the GRAS status of substances that 
directly or indirectly become components of food.
    (b)(1) If the Commissioner proposes on his own initiative that a 
substance is entitled to affirmation as GRAS, he will place all of the 
data and information on which he relies on public file in the office of 
the Dockets Management Branch 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 Dockets Management Branch. Copies of all 
comments received shall be made available for examination in the Dockets 
Management Branch's office.
    (3) The Commissioner will evaluate all comments received. If he 
concludes that there is convincing evidence that the substance is GRAS 
as defined in Sec.  570.3(k), he will publish a notice in the Federal 
Register listing the substance in this subchapter E as GRAS.
    (4) If, after evaluation of the comments, the Commissioner concludes 
that there is a lack of convincing evidence that the substance is GRAS 
and that it should be considered a food additive subject to section 409 
of the act, he shall publish a notice thereof in the Federal Register in 
accordance with Sec.  570.38.
    (c)(1) Persons seeking the affirmation of GRAS status of substances 
as provided for in Sec.  570.30(e), except those subject to the NAS-NRC 
GRAS list survey (36 FR 20546), shall submit a petition for GRAS 
affirmation pursuant to part 10 of this chapter. Such petition shall 
contain information to establish that the GRAS criteria as set forth in 
Sec.  570.30(b) have been met, in the following form:
    (i) Description of the substance, including:
    (a) Common or usual name.
    (b) Chemical name.
    (c) Chemical Abstract Service (CAS) registry number.
    (d) Empirical formula.
    (e) Structural formula.
    (f) Specifications for food grade material, including arsenic and 
heavy metals. (Recommendation for any change in the Food Chemicals Codex 
monograph should be included where applicable.)
    (g) Quantitative compositions.
    (h) Manufacturing process (excluding any trade secrets).
    (ii) Use of the substance, including:
    (a) Date when use began.
    (b) Information and reports or other data on past uses in food.
    (c) Foods in which used, and levels of use in such foods, and for 
what purposes.
    (iii) Methods for detecting the substance in food, including:
    (a) References to qualitative and quantitative methods for 
determining the substance(s) in food, including the type of analytical 
procedures used.
    (b) Sensitivity and reproducibility of such method(s).
    (iv) Information to establish the safety and functionality of the 
substance in food. Published scientific literature,

[[Page 491]]

evidence that the substance is identical to a GRAS counterpart of 
natural biological origin, and other data may be submitted to support 
safety. Any adverse information or consumer complaints shall be 
included. Complete bibliographic references shall be provided where a 
copy of the article is not provided.
    (v) A statement signed by the person responsible for the petition 
that to the best of his knowledge it is a representative and balanced 
submission that includes unfavorable information, as well as favorable 
information, known to him pertinent to the evaluation of the safety and 
functionality of the substance.
    (vi) If nonclinical laboratory studies are involved, additional 
information and data submitted in support of filed petitions 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.
    (vii) [Reserved]
    (viii) A claim for categorical exclusion under Sec.  25.30 or 25.32 
of this chapter or an environmental assessment under Sec.  25.40 of this 
chapter.
    (2) Within 30 days after the date of filing the petition, the 
Commissioner will place the petition on public file in the Dockets 
Management Branch and will publish a notice of filing in the Federal 
Register giving the name of the petitioner and a brief description of 
the petition including the name of the substance, its proposed use, and 
any limitations proposed for reasons other than safety. A copy of the 
notice will be mailed to the petitioner at the time the original is sent 
to the Federal Register.
    (3) The notice of filing in the Federal Register will allow a period 
of 60 days during which any interested person may review the petition 
and/or file comments with the Dockets Management Branch. Copies of all 
comments received shall be made available for examination in the Dockets 
Management Branch.
    (4) The Commissioner will evaluate the petition and all available 
information including all comments received. If the petition and such 
information provide convincing evidence that the substance is GRAS as 
defined in Sec.  570.3, he will publish an order in the Federal Register 
listing the substance in this subchapter E as GRAS.
    (5) If, after evaluation of the petition and all available 
information, the Commissioner concludes that there is a lack of 
convincing evidence that the substance is GRAS and that it should be 
considered a food additive subject to section 409 of the act, he shall 
publish a notice thereof in the Federal Register in accordance with 
Sec.  570.38.
    (6) The notice of filing in the Federal Register will request 
submission of proof of any applicable prior sanction for use of the 
ingredient under conditions different from those proposed to be 
determined to be GRAS. The failure of any person to come forward with 
proof of such an applicable prior sanction in response to the notice of 
filing will constitute a waiver of the right to assert or rely on such 
sanction at any later time. The notice of filing 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 notice of filing.

[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]



Sec.  570.38  Determination of food additive status.

    (a) The Commissioner may, in accordance with Sec.  570.35 (b)(4) or 
(c)(5), publish a notice in the Federal Register determining that a 
substance is not GRAS and is a food additive subject to section 409 of 
the 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

[[Page 492]]

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 Dockets Management Branch 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 Dockets Management Branch. Copies of all 
comments shall be made available for examination in the Dockets 
Management Branch.
    (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]



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

[[Page 493]]

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 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.)

[[Page 494]]

    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.
    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

[[Page 495]]

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 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

[[Page 496]]

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 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

[[Page 497]]

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 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.
573.180 Anhydrous ammonia.
573.200 Condensed animal protein hydrolysate.
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.
573.310 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.
573.500 Condensed, extracted glutamic acid fermentation product.
573.520 Hemicellulose extract.
573.530 Hydrogenated corn syrup.
573.540 Hydrolyzed leather meal.
573.560 Iron ammonium citrate.
573.580 Iron-choline citrate complex.
573.600 Lignin sulfonates.
573.620 Menadione dimethylpyrimidinol bisulfite.
573.625 Menadione nicotinamide bisulfite.
573.640 Methyl esters of higher fatty acids.
573.660 Methyl glucoside-coconut oil ester.
573.680 Mineral oil.
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.

[[Page 498]]

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.
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 
kanr 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 kanr 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.

[[Page 499]]

    (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 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.  573.180  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:
    (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:


[[Page 500]]


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.  573.220  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.
    (iii) The statement ``Do not feed to animals producing milk for 
human consumption.''
    (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.



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, arachidic, and other fatty 
acids may be

[[Page 501]]

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.  573.310  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.


[[Page 502]]


    (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. 
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.



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.

[[Page 503]]

    (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.''



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)(1) The additive is used, or intended for use, to improve the 
handling

[[Page 504]]

characteristics of animal fat in combination with certain oilseed meals 
by producing therefrom a dry, free-flowing product as follows:
    (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., 1976 ed., pages 86, 103, and 109. \1\
---------------------------------------------------------------------------

    \1\ Copies of the current edition may be obtained from the 
Treasurer, Donald H. James, West Virginia Department of Agriculture, 
Capital Complex/Guthrie Center, Charleston, WV 25305.
---------------------------------------------------------------------------

    (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.
    (2) The dried mixture described in paragraph (a) of this section is 
used, or intended for use, as a component of dry, nonpelleted feeds for 
beef and nonlactating dairy cattle.
    (3) To assure safe use of the additive, in addition to the other 
information required by the Act, the label and labeling of the dried 
mixture described in paragraph (a) of this section shall bear:
    (i) The name of the additive.
    (ii) Adequate directions for use providing that feed as consumed is 
not to contain more than 25 percent of the mixture.
    (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 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]



Sec.  573.480  Formic acid.

    Formic acid may be safely 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. The top foot of silage stored 
should not contain formic acid and silage should not be fed to livestock 
within 4 weeks of treatment.

[[Page 505]]



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.
    (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.  573.560  Iron ammonium citrate.

    Iron ammonium citrate may be safely used in animal feed in 
accordance

[[Page 506]]

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.  573.620  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.  573.640  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

[[Page 507]]

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 Association of 
Official Analytical Chemists, 2200 Wilson Blvd., Suite 400, Arlington, 
VA 22201-3301, or available for inspection at the Office of the Federal 
Register, 800 North Capitol Street, NW., suite 700, Washington, DC 
20001.
    (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 Association of Official Analytical 
Chemists, 2200 Wilson Blvd., Suite 400, Arlington, VA 22201-3301, or 
available for inspection at the Office of the Federal Register, 800 
North Capitol Street, NW., suite 700, Washington, DC 20001.) 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:
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.

[[Page 508]]

    (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]



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.  573.700  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,

[[Page 509]]

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.
    (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:

[[Page 510]]

    (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.



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.
Arsenic...................................  3 parts per
                                             million.
------------------------------------------------------------------------
\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.

[[Page 511]]

    (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]



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:

------------------------------------------------------------------------
                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.
Heavy metals as lead......................  10 parts per
                                             million.
------------------------------------------------------------------------

    (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.
Heavy metals as lead......................  10 parts per
                                             million.
------------------------------------------------------------------------

    (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]



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

[[Page 512]]

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 or in a controlled-release 
sodium selenite bolus, as provided in paragraphs (f) and (g) of this 
section, or as selenium yeast, as provided in paragraph (h) of this 
section.
    (c) It 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 feeding at a rate not to exceed an intake of 3 milligrams per 
head per day.
    (d) The additive shall be incorporated into feed as follows:
    (1) 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.
    (2) 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.
    (e) 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.
    (f) 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.''
    (g) 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.''
    (h) The additive selenium yeast is added to complete feed for 
chickens, turkeys, and swine at a level not to exceed 0.3 part per 
million. Usage of this

[[Page 513]]

additive must conform to the requirements of paragraphs (d)(1), (e), and 
(f) 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]

    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 in feed components as an 
anticaking agent, and/or grinding aid, as follows:

------------------------------------------------------------------------
                                                             Limitations
                       Feed component                         (percent)
------------------------------------------------------------------------
BHT (butylated hydroxytoluene).............................            2
Methionine hydroxy analog and its calcium salts............            1
Piperazine, piperazine salts...............................          0.8
Sodium propionate..........................................            1
Urea.......................................................            1
Vitamins...................................................            3
------------------------------------------------------------------------

    (c) It is used in feed as an anticaking agent in an amount not to 
exceed that reasonably required to accomplish its intended effect and in 
no case in an amount to exceed 2 percent by weight of the finished feed.



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.

[[Page 514]]

    (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 an 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 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.

[51 FR 5993, Feb. 19, 1986]



               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:

[[Page 515]]



------------------------------------------------------------------------
      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 gamma rays from 
sealed units of cobalt-60.
    (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]



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.

[[Page 516]]

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.
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.

[[Page 517]]

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.
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

[[Page 518]]

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 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.

[[Page 519]]

 
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.
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.

[[Page 520]]

 
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.
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.

[[Page 521]]

 
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.
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.

[[Page 522]]

 
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.
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.

[[Page 523]]

 
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).
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.
Geranoil (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).
1-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 180.1001(c) 
and (d), 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.



                Subpart B--General Purpose Food Additives



Sec.  582.1005  Acetic acid.

    (a) Product. Acetic acid.

[[Page 524]]

    (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]
    (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.

[[Page 525]]

    (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 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.

[[Page 526]]

    (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 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.

[[Page 527]]

    (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.



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.

[[Page 528]]



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.



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.

[[Page 529]]

    (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).
    (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.

[[Page 530]]



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.



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.

[[Page 531]]



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 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.

[[Page 532]]



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.



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.

[[Page 533]]

    (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.



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.

[[Page 534]]



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).
    (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

[[Page 535]]

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.



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).

[[Page 536]]

    (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.
    (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.

[[Page 537]]



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.
    (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.

[[Page 538]]



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.



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.

[[Page 539]]



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.



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.

[[Page 540]]



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]

       Subpart B--Listing of Specific Substances Affirmed as GRAS

Sec.
584.200 Ethyl alcohol containing ethyl acetate.
584.700 Hydrophobic silicas.

    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 212.45, 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]



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]



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.


[[Page 541]]


    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 effective notice of 
claimed investigational exemption for a new animal drug under part 511 
of this chapter.

[56 FR 40507, Aug. 15, 1991]



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 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; 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.

[[Page 542]]

    (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 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

[[Page 543]]

whose design has been made available to the public.
    (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;
    (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.
    (f) Requirements for establishments and individuals that are 
responsible for feeding ruminant animals. Establishments and individuals 
that are responsible for

[[Page 544]]

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]

    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.

                        PARTS 590-599 [RESERVED]

[[Page 545]]



                              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.

  Material Approved for Incorporation by Reference
  Table of CFR Titles and Chapters
  Alphabetical List of Agencies Appearing in the CFR
  List of CFR Sections Affected

[[Page 547]]

            Material Approved for Incorporation by Reference

                      (Revised as of April 1, 2003)

  The Director of the Federal Register has approved under 5 U.S.C. 
552(a) and 1 CFR Part 51 the incorporation by reference of the following 
publications. This list contains only those incorporations by reference 
effective as of the revision date of this volume. Incorporations by 
reference found within a regulation are effective upon the effective 
date of that regulation. For more information on incorporation by 
reference, see the preliminary pages of this volume.


21 CFR (PARTS 500 TO 599)

FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
                                                                  21 CFR


Academic Press, Inc.

  111 Fifth Ave., New York, NY 10003
Method published in ``Methods in Hormone                      556.710(b)
  Research,'' New York, Academic Press, Volume II, 
  p. 286 (1962).


AOAC International (Association of Official Analytical Chemists)

  481 N. Frederick Ave., Suite 500, Gaithersburg, 
  MD 20877-2417 Telephone: (301) 924-7077
Official Methods of Analysis, 13th Ed., 1980......            520.2320; 
                                                   573.640(b)(4)(i) and 
                                                                    (ii)
  Note: The following materials are available 
  through the Food and Drug Administration at the 
  addresses indicated.


Center for Food Safety and Applied Nutrition, Food and Drug 
Administration

  5100 Paint Branch Parkway, College Park, 
  Maryland 20740
Journal of the Association of Official Analytical Chemists:
  ``Oils, Fats, and Waxes'' Vol. 44(1) 146 (1961)......573.640(b)(4)(ii)
Weight Method of E. J. Emberg, G. H. Gass and J.              556.250(b)
  M. Curtis, published in ``Endocrinology'', Vol. 
  63, p. 806 (1958).


Dockets Management Branch (HFA-305), Food and Drug Administration

  5600 Fishers Lane, Room 4-62, Rockville, MD 
  20857
Determination of Factor Content in Tylosin by High 520.2640; 522.2640a; 
  Performance Liquid Chromatography.               522.2640b; 524.2640; 
                                                        558.625; 558.630



[[Page 549]]



                    Table of CFR Titles and Chapters




                      (Revised as of April 1, 2003)

                      Title 1--General Provisions

         I  Administrative Committee of the Federal Register 
                (Parts 1--49)
        II  Office of the Federal Register (Parts 50--299)
        IV  Miscellaneous Agencies (Parts 400--500)

                          Title 2 [Reserved]

                        Title 3--The President

         I  Executive Office of the President (Parts 100--199)

                           Title 4--Accounts

         I  General Accounting Office (Parts 1--99)

                   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)
         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 (Part 2100)
       XIV  Federal Labor Relations Authority, General Counsel of 
                the Federal Labor Relations Authority and Federal 
                Service Impasses Panel (Parts 2400--2499)
        XV  Office of Administration, Executive Office of the 
                President (Parts 2500--2599)
       XVI  Office of Government Ethics (Parts 2600--2699)
       XXI  Department of the Treasury (Parts 3100--3199)
      XXII  Federal Deposit Insurance Corporation (Part 3201)
     XXIII  Department of Energy (Part 3301)
      XXIV  Federal Energy Regulatory Commission (Part 3401)
       XXV  Department of the Interior (Part 3501)
      XXVI  Department of Defense (Part 3601)

[[Page 550]]

    XXVIII  Department of Justice (Part 3801)
      XXIX  Federal Communications Commission (Parts 3900--3999)
       XXX  Farm Credit System Insurance Corporation (Parts 4000--
                4099)
      XXXI  Farm Credit Administration (Parts 4100--4199)
    XXXIII  Overseas Private Investment Corporation (Part 4301)
      XXXV  Office of Personnel Management (Part 4501)
        XL  Interstate Commerce Commission (Part 5001)
       XLI  Commodity Futures Trading Commission (Part 5101)
      XLII  Department of Labor (Part 5201)
     XLIII  National Science Foundation (Part 5301)
       XLV  Department of Health and Human Services (Part 5501)
      XLVI  Postal Rate Commission (Part 5601)
     XLVII  Federal Trade Commission (Part 5701)
    XLVIII  Nuclear Regulatory Commission (Part 5801)
         L  Department of Transportation (Part 6001)
       LII  Export-Import Bank of the United States (Part 6201)
      LIII  Department of Education (Parts 6300--6399)
       LIV  Environmental Protection Agency (Part 6401)
      LVII  General Services Administration (Part 6701)
     LVIII  Board of Governors of the Federal Reserve System (Part 
                6801)
       LIX  National Aeronautics and Space Administration (Part 
                6901)
        LX  United States Postal Service (Part 7001)
       LXI  National Labor Relations Board (Part 7101)
      LXII  Equal Employment Opportunity Commission (Part 7201)
     LXIII  Inter-American Foundation (Part 7301)
       LXV  Department of Housing and Urban Development (Part 
                7501)
      LXVI  National Archives and Records Administration (Part 
                7601)
      LXIX  Tennessee Valley Authority (Part 7901)
      LXXI  Consumer Product Safety Commission (Part 8101)
    LXXIII  Department of Agriculture (Part 8301)
     LXXIV  Federal Mine Safety and Health Review Commission (Part 
                8401)
     LXXVI  Federal Retirement Thrift Investment Board (Part 8601)
    LXXVII  Office of Management and Budget (Part 8701)

                      Title 6--Homeland Security

         I  Department of Homeland Security, Office of the 
                Secretary (Parts 0--100)

                         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)

[[Page 551]]

        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  Grain Inspection, Packers and Stockyards 
                Administration (Federal Grain Inspection Service), 
                Department of Agriculture (Parts 800--899)
        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  Rural Telephone Bank, Department of Agriculture (Parts 
                1600--1699)
      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  Local Television Loan Guarantee Board (Parts 2200--
                2299)
      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, 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)

[[Page 552]]

     XXXIV  Cooperative State Research, Education, and Extension 
                Service, Department of 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)

                    Title 8--Aliens and Nationality

         I  Immigration and Naturalization Service, Department of 
                Homeland Security (Parts 1--599)
         V  Executive Office for Immigration Review, Department of 
                Justice (Parts 1000--1400)

                 Title 9--Animals and Animal Products

         I  Animal and Plant Health Inspection Service, Department 
                of Agriculture (Parts 1--199)
        II  Grain Inspection, Packers and Stockyards 
                Administration (Packers and Stockyards Programs), 
                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)
      XVII  Defense Nuclear Facilities Safety Board (Parts 1700--
                1799)
     XVIII  Northeast Interstate Low-Level Radioactive Waste 
                Commission (Part 1800)

                      Title 11--Federal Elections

         I  Federal Election Commission (Parts 1--9099)

                      Title 12--Banks and Banking

         I  Comptroller of the Currency, Department of the 
                Treasury (Parts 1--199)

[[Page 553]]

        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  Office of Thrift Supervision, Department of the 
                Treasury (Parts 500--599)
        VI  Farm Credit Administration (Parts 600--699)
       VII  National Credit Union Administration (Parts 700--799)
      VIII  Federal Financing Bank (Parts 800--899)
        IX  Federal Housing Finance Board (Parts 900--999)
        XI  Federal Financial Institutions Examination Council 
                (Parts 1100--1199)
       XIV  Farm Credit System Insurance Corporation (Parts 1400--
                1499)
        XV  Department of the Treasury (Parts 1500--1599)
      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--499)
         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)

[[Page 554]]

       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)
      VIII  Bureau of Economic Analysis, Department of Commerce 
                (Parts 800--899)
        IX  National Oceanic and Atmospheric Administration, 
                Department of Commerce (Parts 900--999)
        XI  Technology Administration, 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)

                    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  United States Customs Service, Department of the 
                Treasury (Parts 1--199)
        II  United States International Trade Commission (Parts 
                200--299)

[[Page 555]]

       III  International Trade Administration, Department of 
                Commerce (Parts 300--399)

                     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  Employment Standards Administration, 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, 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  Broadcasting Board of Governors (Parts 500--599)
       VII  Overseas Private Investment 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)
       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)

[[Page 556]]

       XVI  Japan-United States Friendship Commission (Parts 
                1600--1699)
      XVII  United States Institute of Peace (Parts 1700--1799)

                          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) (Parts 1700--1799)

[[Page 557]]

       XII  Office of Inspector General, Department of Housing and 
                Urban Development (Parts 2000--2099)
        XX  Office of Assistant Secretary for Housing--Federal 
                Housing Commissioner, Department of Housing and 
                Urban Development (Parts 3200--3899)
       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--799)
         V  Bureau of Indian Affairs, Department of the Interior, 
                and Indian Health Service, Department of Health 
                and Human Services (Part 900)
        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 (Part 1200)

                      Title 26--Internal Revenue

         I  Internal Revenue Service, Department of the Treasury 
                (Parts 1--899)

           Title 27--Alcohol, Tobacco Products and Firearms

         I  Alcohol and Tobacco Tax and Trade Bureau, Department 
                of the Treasury (Parts 1--299)
        II  Bureau of Alcohol, Tobacco, Firearms, and Explosives, 
                Department of Justice (Parts 400--699)

                   Title 28--Judicial Administration

         I  Department of Justice (Parts 0--199)
       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)

[[Page 558]]

        XI  Department of Justice and Department of State (Parts 
                1100--1199)

                            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  Pension and Welfare Benefits 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  Minerals Management Service, Department of the 
                Interior (Parts 200--299)
       III  Board of Surface Mining and Reclamation Appeals, 
                Department of the Interior (Parts 300--399)
        IV  Geological Survey, Department of the Interior (Parts 
                400--499)
       VII  Office of Surface Mining Reclamation and Enforcement, 
                Department of the Interior (Parts 700--999)

                 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)

[[Page 559]]

        IV  Secret Service, Department of the Treasury (Parts 
                400--499)
         V  Office of Foreign Assets Control, Department of the 
                Treasury (Parts 500--599)
        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 International Investment, Department of the 
                Treasury (Parts 800--899)
        IX  Federal Claims Collection Standards (Department of the 
                Treasury--Department of Justice) (Parts 900--999)

                      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  Defense Logistics Agency (Parts 1200--1299)
       XVI  Selective Service System (Parts 1600--1699)
     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 Transportation (Parts 1--
                199)
        II  Corps of Engineers, Department of the Army (Parts 
                200--399)
        IV  Saint 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
         I  Office for Civil Rights, Department of Education 
                (Parts 100--199)

[[Page 560]]

        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 Vocational and Adult Education, Department 
                of Education (Parts 400--499)
         V  Office of Bilingual Education and Minority Languages 
                Affairs, Department of Education (Parts 500--599)
        VI  Office of Postsecondary Education, Department of 
                Education (Parts 600--699)
        XI  National Institute for Literacy (Parts 1100--1199)
            Subtitle C--Regulations Relating to Education
       XII  National Council on Disability (Parts 1200--1299)

                        Title 35--Panama Canal

         I  Panama Canal Regulations (Parts 1--299)

             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)
       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 (Part 1501)
       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  Copyright Office, Library of Congress (Parts 200--299)
        IV  Assistant Secretary for Technology Policy, Department 
                of Commerce (Parts 400--499)
         V  Under Secretary for Technology, Department of Commerce 
                (Parts 500--599)

[[Page 561]]

           Title 38--Pensions, Bonuses, and Veterans' Relief

         I  Department of Veterans Affairs (Parts 0--99)

                       Title 39--Postal Service

         I  United States Postal Service (Parts 1--999)
       III  Postal Rate Commission (Parts 3000--3099)

                  Title 40--Protection of Environment

         I  Environmental Protection Agency (Parts 1--799)
        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)

          Title 41--Public Contracts and Property Management

            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)
            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)
       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)
            Subtitle D--Other Provisions Relating to Property 
                Management [Reserved]
            Subtitle E--Federal Information Resources Management 
                Regulations System
       201  Federal Information Resources Management Regulation 
                (Parts 201-1--201-99) [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)

[[Page 562]]

       302  Relocation Allowances (Parts 302-1--302-99)
       303  Payment of Expenses Connected with the Death of 
                Certain Employees (Part 303-70)
       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)
        IV  Centers for Medicare & Medicaid Services, Department 
                of Health and Human Services (Parts 400--499)
         V  Office of Inspector General-Health Care, Department of 
                Health and Human Services (Parts 1000--1999)

                   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 200--499)
        II  Bureau of Land Management, Department of the Interior 
                (Parts 1000--9999)
       III  Utah Reclamation Mitigation and Conservation 
                Commission (Parts 10000--10005)

             Title 44--Emergency Management and Assistance

         I  Federal Emergency Management Agency (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
        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)

[[Page 563]]

       VII  Commission on Civil Rights (Parts 700--799)
      VIII  Office of Personnel Management (Parts 800--899)
         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  Office of Human Development Services, 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 on Fine Arts (Parts 2100--2199)
     XXIII  Arctic Research Commission (Part 2301)
      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 Transportation (Parts 1--
                199)
        II  Maritime Administration, Department of Transportation 
                (Parts 200--399)
       III  Coast Guard (Great Lakes Pilotage), Department of 
                Transportation (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)
       III  National Telecommunications and Information 
                Administration, Department of Commerce (Parts 
                300--399)

           Title 48--Federal Acquisition Regulations System

         1  Federal Acquisition Regulation (Parts 1--99)
         2  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)

[[Page 564]]

         7  United States 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)
        34  Department of Education Acquisition Regulation (Parts 
                3400--3499)
        35  Panama Canal Commission (Parts 3500--3599)
        44  Federal Emergency Management Agency (Parts 4400--4499)
        51  Department of the Army Acquisition Regulations (Parts 
                5100--5199)
        52  Department of the Navy Acquisition Regulations (Parts 
                5200--5299)
        53  Department of the Air Force Federal Acquisition 
                Regulation Supplement (Parts 5300--5399)
        54  Defense Logistics Agency, Department of Defense (Parts 
                5400--5499)
        57  African Development Foundation (Parts 5700--5799)
        61  General Services Administration Board of Contract 
                Appeals (Parts 6100--6199)
        63  Department of Transportation Board of Contract Appeals 
                (Parts 6300--6399)
        99  Cost Accounting Standards Board, Office of Federal 
                Procurement Policy, Office of Management and 
                Budget (Parts 9900--9999)

[[Page 565]]

                       Title 49--Transportation

            Subtitle A--Office of the Secretary of Transportation 
                (Parts 1--99)
            Subtitle B--Other Regulations Relating to 
                Transportation
         I  Research and Special Programs 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 Transportation (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, Department of 
                Transportation (Parts 1000--1399)
        XI  Bureau of Transportation Statistics, Department of 
                Transportation (Parts 1400--1499)
       XII  Transportation Security Administration, Department of 
                Transportation (Parts 1500--1599)

                   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)
        VI  Fishery Conservation and Management, National Oceanic 
                and Atmospheric Administration, Department of 
                Commerce (Parts 600--699)

                      CFR Index and Finding Aids

            Subject/Agency Index
            List of Agency Prepared Indexes
            Parallel Tables of Statutory Authorities and Rules
            List of CFR Titles, Chapters, Subchapters, and Parts
            Alphabetical List of Agencies Appearing in the CFR



[[Page 567]]





           Alphabetical List of Agencies Appearing in the CFR




                      (Revised as of April 1, 2003)

                                                  CFR Title, Subtitle or 
                     Agency                               Chapter

Administrative Committee of the Federal Register  1, I
Advanced Research Projects Agency                 32, I
Advisory Council on Historic Preservation         36, VIII
African Development Foundation                    22, XV
  Federal Acquisition Regulation                  48, 57
Agency for International Development, United      22, II
     States
  Federal Acquisition Regulation                  48, 7
Agricultural Marketing Service                    7, I, IX, X, XI
Agricultural Research Service                     7, V
Agriculture Department                            5, LXXIII
  Agricultural Marketing Service                  7, I, IX, X, XI
  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
  Cooperative State Research, Education, and      7, XXXIV
       Extension Service
  Economic Research Service                       7, XXXVII
  Energy, Office of                               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
  Grain Inspection, Packers and Stockyards        7, VIII; 9, II
       Administration
  Information Resources Management, Office of     7, XXVII
  Inspector General, Office of                    7, XXVI
  National Agricultural Library                   7, XLI
  National Agricultural Statistics Service        7, XXXVI
  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 Telephone Bank                            7, XVI
  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                              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

[[Page 568]]

Architectural and Transportation Barriers         36, XI
     Compliance Board
Arctic Research Commission                        45, XXIII
Armed Forces Retirement Home                      5, XI
Army Department                                   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
Broadcasting Board of Governors                   22, V
  Federal Acquisition Regulation                  48, 19
Census Bureau                                     15, I
Centers for Medicare & Medicaid Services          42, IV
Central Intelligence Agency                       32, XIX
Chief Financial Officer, Office of                7, XXX
Child Support Enforcement, Office of              45, III
Children and Families, Administration for         45, II, III, IV, X
Civil Rights, Commission on                       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                               44, IV
  Census Bureau                                   15, I
  Economic Affairs, Under Secretary               37, V
  Economic Analysis, Bureau of                    15, VIII
  Economic Development Administration             13, III
  Emergency Management and Assistance             44, IV
  Federal Acquisition Regulation                  48, 13
  Fishery Conservation and Management             50, VI
  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
  National Marine Fisheries Service               50, II, IV, VI
  National Oceanic and Atmospheric                15, IX; 50, II, III, IV, 
       Administration                             VI
  National Telecommunications and Information     15, XXIII; 47, III
       Administration
  National Weather Service                        15, IX
  Patent and Trademark Office, United States      37, I
  Productivity, Technology and Innovation,        37, IV
       Assistant Secretary for
  Secretary of Commerce, Office of                15, Subtitle A
  Technology, Under Secretary for                 37, V
  Technology Administration                       15, XI
  Technology Policy, Assistant Secretary for      37, IV
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 Product Safety Commission                5, LXXI; 16, II
Cooperative State Research, Education, and        7, XXXIV
     Extension Service
Copyright Office                                  37, II
Corporation for National and Community Service    45, XII, XXV
Cost Accounting Standards Board                   48, 99
Council on Environmental Quality                  40, V
Court Services and Offender Supervision Agency    28, VIII
     for the District of Columbia
Customs Service, United States                    19, I
Defense Contract Audit Agency                     32, I
Defense Department                                5, XXVI; 32, Subtitle A; 
                                                  40, VII

[[Page 569]]

  Advanced Research Projects Agency               32, I
  Air Force Department                            32, VII
  Army Department                                 32, V; 33, II; 36, III, 
                                                  48, 51
  Defense Intelligence Agency                     32, I
  Defense Logistics Agency                        32, I, XII; 48, 54
  Engineers, Corps of                             33, II; 36, III
  Federal Acquisition Regulation                  48, 2
  National Imagery and Mapping Agency             32, I
  Navy Department                                 32, VI; 48, 52
  Secretary of Defense, Office of                 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
District of Columbia, Court Services and          28, VIII
     Offender Supervision Agency for the
Drug Enforcement Administration                   21, II
East-West Foreign Trade Board                     15, XIII
Economic Affairs, Under Secretary                 37, V
Economic Analysis, Bureau of                      15, VIII
Economic Development Administration               13, III
Economic Research Service                         7, XXXVII
Education, Department of                          5, LIII
  Bilingual Education and Minority Languages      34, V
       Affairs, Office 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
  Vocational and Adult Education, Office of       34, IV
Educational Research and Improvement, Office of   34, VII
Elementary and Secondary Education, Office of     34, II
Emergency Oil and Gas Guaranteed Loan Board       13, V
Emergency Steel Guarantee Loan Board              13, IV
Employees' Compensation Appeals Board             20, IV
Employees Loyalty Board                           5, V
Employment and Training Administration            20, V
Employment Standards Administration               20, VI
Endangered Species Committee                      50, IV
Energy, Department of                             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                   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
  Administration, Office of                       5, XV
  Environmental Quality, Council on               40, V
  Management and Budget, Office of                5, III, LXXVII; 14, VI; 
                                                  48, 99
  National Drug Control Policy, Office of         21, III
  National Security Council                       32, XXI; 47, 2
  Presidential Documents                          3
  Science and Technology Policy, Office of        32, XXIV; 47, II
  Trade Representative, Office of the United      15, XX
     States
[[Page 570]]

Export-Import Bank of the United States           5, LII; 12, IV
Family Assistance, Office of                      45, II
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                       11, I
Federal Emergency Management Agency               44, I
  Federal Acquisition Regulation                  48, 44
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 Board                     12, IX
Federal Labor Relations Authority, and General    5, XIV; 22, XIV
     Counsel of the Federal Labor Relations 
     Authority
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 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
Fine Arts, Commission on                          45, XXI
Fiscal Service                                    31, II
Fish and Wildlife Service, United States          50, I, IV
Fishery Conservation and Management               50, VI
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 Accounting Office                         4, I
General Services Administration                   5, LVII; 41, 105
  Contract Appeals, Board of                      48, 61
  Federal Acquisition Regulation                  48, 5
  Federal Management Regulation                   41, 102

[[Page 571]]

  Federal Property Management Regulation          41, 101
  Federal Travel Regulation System                41, Subtitle F
  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 Ethics, Office of                      5, XVI
Government National Mortgage Association          24, III
Grain Inspection, Packers and Stockyards          7, VIII; 9, II
     Administration
Harry S. Truman Scholarship Foundation            45, XVIII
Health and Human Services, Department of          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
  Community Services, Office of                   45, X
  Family Assistance, Office of                    45, II
  Federal Acquisition Regulation                  48, 3
  Food and Drug Administration                    21, I
  Human Development Services, Office of           45, XIII
  Indian Health Service                           25, V; 42, I
  Inspector General (Health Care), Office of      42, V
  Public Health Service                           42, I
  Refugee Resettlement, Office of                 45, IV
Homeland Security, Department of                  6, I
  Immigration and Naturalization Service          8, I
Housing and Urban Development, Department of      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
Human Development Services, Office of             45, XIII
Immigration and Naturalization Service            8, I
Immigration Review, Executive Office for          8, V
Independent Counsel, Office of                    28, VII
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; 42, I
Industry and Security, Bureau of                  15, VII
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
Institute of Peace, United States                 22, XVII
Inter-American Foundation                         5, LXIII; 22, X
Interior Department
  American Indians, Office of the Special         25, VII
       Trustee
  Endangered Species Committee                    50, IV

[[Page 572]]

  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
  Minerals Management Service                     30, II
  National Indian Gaming Commission               25, III
  National Park Service                           36, I
  Reclamation, Bureau of                          43, I
  Secretary of the Interior, Office of            43, Subtitle A
  Surface Mining and Reclamation Appeals, Board   30, III
       of
  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 Fishing and Related Activities      50, III
International Investment, Office of               31, VIII
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
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                                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
  Offices of Independent Counsel                  28, VI
  Prisons, Bureau of                              28, V
  Property Management Regulations                 41, 128
Labor Department                                  5, XLII
  Benefits Review Board                           20, VII
  Employees' Compensation Appeals Board           20, IV
  Employment and Training Administration          20, V
  Employment Standards Administration             20, VI
  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
  Mine Safety and Health Administration           30, I
  Occupational Safety and Health Administration   29, XVII
  Pension and Welfare Benefits Administration     29, XXV
  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
Labor-Management Standards, Office of             29, II, IV
Land Management, Bureau of                        43, II
Legal Services Corporation                        45, XVI
Library of Congress                               36, VII

[[Page 573]]

  Copyright Office                                37, II
Local Television Loan Guarantee Board             7, XX
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
Micronesian Status Negotiations, Office for       32, XXVII
Mine Safety and Health Administration             30, I
Minerals Management Service                       30, II
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
National Aeronautics and Space Administration     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   45, XII, XXV
National Archives and Records Administration      5, LXVI; 36, XII
  Information Security Oversight Office           32, XX
National Bureau of Standards                      15, II
National Capital Planning Commission              1, IV
National Commission for Employment Policy         1, IV
National Commission on Libraries and Information  45, XVII
     Science
National Council on Disability                    34, XII
National Counterintelligence Center               32, XVIII
National Credit Union Administration              12, VII
National Crime Prevention and Privacy Compact     28, IX
     Council
National Drug Control Policy, Office of           21, III
National Foundation on the Arts and the           45, XI
     Humanities
National Highway Traffic Safety Administration    23, II, III; 49, V
National Imagery and Mapping Agency               32, I
National Indian Gaming Commission                 25, III
National Institute for Literacy                   34, XI
National Institute of Standards and Technology    15, II
National Labor Relations Board                    5, LXI; 29, I
National Marine Fisheries Service                 50, II, IV, VI
National Mediation Board                          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                       5, XLIII; 45, VI
  Federal Acquisition Regulation                  48, 25
National Security Council                         32, XXI
National Security Council and Office of Science   47, II
     and Technology Policy
National Telecommunications and Information       15, XXIII; 47, III
     Administration
National Transportation Safety Board              49, VIII
National Weather Service                          15, IX
Natural Resources Conservation Service            7, VI
Navajo and Hopi Indian Relocation, Office of      25, IV
Navy Department                                   32, VI
  Federal Acquisition Regulation                  48, 52
Neighborhood Reinvestment Corporation             24, XXV
Northeast Interstate Low-Level Radioactive Waste  10, XVIII
     Commission
Nuclear Regulatory Commission                     5, XLVIII; 10, I
  Federal Acquisition Regulation                  48, 20
Occupational Safety and Health Administration     29, XVII
Occupational Safety and Health Review Commission  29, XX
Offices of Independent Counsel                    28, VI
Oklahoma City National Memorial Trust             36, XV
Operations Office                                 7, XXVIII

[[Page 574]]

Overseas Private Investment Corporation           5, XXXIII; 22, VII
Panama Canal Commission                           48, 35
Panama Canal Regulations                          35, I
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                                       22, III
Pennsylvania Avenue Development Corporation       36, IX
Pension and Welfare Benefits Administration       29, XXV
Pension Benefit Guaranty Corporation              29, XL
Personnel Management, Office of                   5, I, 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
Postal Rate 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
Procurement and Property Management, Office of    7, XXXII
Productivity, Technology and Innovation,          37, IV
     Assistant Secretary
Public Contracts, Department of Labor             41, 50
Public and Indian Housing, Office of Assistant    24, IX
     Secretary for
Public Health Service                             42, I
Railroad Retirement Board                         20, II
Reclamation, Bureau of                            43, I
Refugee Resettlement, Office of                   45, IV
Regional Action Planning Commissions              13, V
Relocation Allowances                             41, 302
Research and Special Programs Administration      49, I
Rural Business-Cooperative Service                7, XVIII, XLII
Rural Development Administration                  7, XLII
Rural Housing Service                             7, XVIII, XXXV
Rural Telephone Bank                              7, XVI
Rural Utilities Service                           7, XVII, XVIII, XLII
Saint Lawrence Seaway Development Corporation     33, IV
Science and Technology Policy, Office of          32, XXIV
Science and Technology Policy, Office of, and     47, II
     National Security Council
Secret Service                                    31, IV
Securities and Exchange Commission                17, II
Selective Service System                          32, XVI
Small Business Administration                     13, I
Smithsonian Institution                           36, V
Social Security Administration                    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                                  22, I; 28, XI
  Federal Acquisition Regulation                  48, 6
Surface Mining and Reclamation Appeals, Board of  30, III
Surface Mining Reclamation and Enforcement,       30, VII
     Office of
Surface Transportation Board                      49, X
Susquehanna River Basin Commission                18, VIII
Technology Administration                         15, XI
Technology Policy, Assistant Secretary for        37, IV
Technology, Under Secretary for                   37, V
Tennessee Valley Authority                        5, LXIX; 18, XIII
Thrift Supervision Office, Department of the      12, V
     Treasury
Trade Representative, United States, Office of    15, XX
Transportation, Department of                     5, L
  Coast Guard                                     33, I; 46, I; 49, IV

[[Page 575]]

  Coast Guard (Great Lakes Pilotage)              46, III
  Commercial Space Transportation                 14, III
  Contract Appeals, Board of                      48, 63
  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; 49, V
  Research and Special Programs Administration    49, I
  Saint Lawrence Seaway Development Corporation   33, IV
  Secretary of Transportation, Office of          14, II; 49, Subtitle A
  Surface Transportation Board                    49, X
  Transportation Security Administration          49, XII
  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                               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 Service, United States                  19, I
  Engraving and Printing, Bureau of               31, VI
  Federal Acquisition Regulation                  48, 10
  Federal Law Enforcement Training Center         31, VII
  Fiscal Service                                  31, II
  Foreign Assets Control, Office of               31, V
  Internal Revenue Service                        26, I
  International Investment, Office of             31, VIII
  Monetary Offices                                31, I
  Secret Service                                  31, IV
  Secretary of the Treasury, Office of            31, Subtitle A
  Thrift Supervision, Office of                   12, V
Truman, Harry S. Scholarship Foundation           45, XVIII
United States and Canada, International Joint     22, IV
     Commission
United States and Mexico, International Boundary  22, XI
     and Water Commission, United States Section
Utah Reclamation Mitigation and Conservation      43, III
     Commission
Veterans Affairs Department                       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
Vocational and Adult Education, Office of         34, IV
Wage and Hour Division                            29, V
Water Resources Council                           18, VI
Workers' Compensation Programs, Office of         20, I
World Agricultural Outlook Board                  7, XXXVIII

[[Page 577]]



List of CFR Sections Affected



All changes in this volume of the Code of Federal Regulations which were 
made by documents published in the Federal Register since January 1, 
2001, 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 and parts as well as 
sections for revisions.
For the period before January 1, 2001, see the ``List of CFR Sections 
Affected, 1949-1963, 1964-1972, 1973-1985, and 1986-2000'' published in 
11 separate volumes.

                                  2001

21 CFR
                                                                   66 FR
                                                                    Page
Chapter I
510.600 (c)(1) table and (2) table amended....7578, 13426, 13847, 14073, 
         15348, 17510, 22117, 22118, 23588, 32739, 36162, 43773, 46367, 
                  46368, 46519, 47960, 56035, 63163, 63164, 63500, 66742
520.48 Revised.....................................................47960
520.309 (a) amended; (d) revised...................................63165
520.390a (b)(2) amended............................................14073
520.445b (b) and (d)(4)(iii)(C) amended............................35898
520.447 (b) amended................................................13848
520.540b (b)(2) amended............................................14073
520.622a (a)(3) amended............................................14073
520.622c (b)(4) amended............................................14073
520.823 (b) amended................................................14073
520.905a (b) amended...............................................47960
520.905b (b) amended...............................................47960
520.905c (b) amended...............................................47960
520.905d (b) amended...............................................47960
520.905e (b) amended...............................................47960
520.1010 Revised...................................................47960
520.1010a Removed..................................................47961
520.1010b Removed..................................................47961
520.1010c Removed..................................................47961
520.1195 (b) amended................................................7579
    (b), (c)(2) and (3) amended; (c) heading and (1) revised.......63166
520.1196 (b) amended...............................................35756
520.1310 (a) and (d) revised.......................................46369
520.1484 (b) amended...............................................14073
520.1660d (b)(7) amended...........................................14073
    (d)(1)(ii)(A)(3), (B)(3), (C)(3) and (iii)(C) amended..........21282
    (d)(1)(iii)(C) amended.........................................29020
    (a)(9), (d)(1)(ii)(A)(3), (B)(3), (C)(3) and (iii)(C) amended 
                                                                   58935
520.1696b (b) amended..............................................14073
520.1720a (b)(3) amended...........................................14073
    (b)(2) and (3) amended.........................................14316
    (b)(3) amended.................................................15349
520.1720d (b) amended..............................................14073
520.1840 (a), (b) and (c) revised..................................47963
520.1855 Added.....................................................43774
520.2041 (b) amended................................................9650
520.2095 Removed...................................................21282
520.2123a (b) amended..............................................14073
520.2123b (b) amended..............................................14073
520.2260b (c)(1) and (e)(1) amended................................14073
520.2460 Removed...................................................22117
520.2460a Removed..................................................22117
520.2460b Removed..................................................22117
520.2520a Removed..................................................23588
522.313 Heading revised; (d)(8) added..............................21283
    (d)(1)(i) amended..............................................32540
522.575 (b) amended................................................46705
522.820 (a) amended................................................14073
522.840 (b) amended................................................56035
522.1010 Revised...................................................47961
522.1081 (b) removed...............................................22117
522.1183 (c) removed...............................................22117
522.1192 (b) revised...............................................13236
522.1258 Removed...................................................23588
522.1451 Added.....................................................35756
522.1660 (d)(1)(iii) amended.......................................13235
522.1680 (b) amended...............................................22117
522.1696a Revised....................................................711
522.1696b Revised....................................................712
522.1704 (b) removed...............................................23588
522.1720 (b)(1) amended............................................15349

[[Page 578]]

522.1884 (c) amended; (d)(2)(iv) removed...........................23589
522.2095 Removed...................................................21282
522.2120 (b) amended...............................................22118
522.2444b (b) amended..............................................14073
522.2476 Revised...................................................47961
522.2477 (b) revised...............................................47961
522.2640b Removed..................................................22117
524.321 Revised....................................................22117
524.390c Removed...................................................42731
524.520 (b) amended................................................46706
524.1044h Added......................................................712
524.1193 (a) amended; (d) redesignated as (e); new (d) added; (b) 
        and new (e) revised........................................13236
    (b) and (e)(2) amended.........................................63165
524.1195 Added......................................................7578
524.1446 (c)(1) and (2) amended....................................13849
524.1451 (d) redesignated as (e); new (d) added; new (e)(2) 
        revised; new (e)(3) amended................................46370
524.1580b (b) amended..............................................14074
524.2140 Removed...................................................42731
524.2620 (a)(2) amended............................................46369
524.2640 Removed...................................................22117
526.820 (b) amended................................................14074
529.360 Removed....................................................22117
529.1186 (b) amended...............................................17510
556.163 Revised....................................................35544
556.175 Redesignated as 556.185....................................62917
556.185 Redesignated from 556.175; (b)(1) revised; (b)(2) added....62917
556.347 Revised....................................................19854
556.428 Revised....................................................23589
556.500 (b) revised................................................46370
556.594 Removed....................................................21282
558.4 (d) amended..................................................21862
558.55 (d)(2) table amended.................................20083, 20402
    (d)(2)(iii) table amended......................................47962
558.58 (d)(1) table amended........................................14074
    (d)(1) table amended; (d)(1)(v) removed........................46519
    (d)(1)(iii) table amended...............................46706, 47963
    (d)(1)(ii) table and (iii) table amended.......................47962
558.62 (a)(1) revised; (a)(3) added; (c)(1) table amended..........14074
    (c)(1) table amended...........................................57873
558.76 (d)(1)(iv) table amended....................................46706
558.78 (a)(1) revised; (a)(2) removed; (a)(3) redesignated as 
        (a)(2); (d)(1) table and (2)(ii) amended...................46706
558.95 (d)(5)(iv) and (v) amended..................................27022
    (d)(1)(x) removed; (d)(1)(xi)(b), (xii)(b) and (xiv)(b) 
amended............................................................46706
    (a)(1), (2), (5), (d)(1)(vi)(b), (vii)(b), (xi)(b) and 
(xii)(b) amended...................................................47962
558.108 (b) and (d)(1) amended; (d)(2) added.......................62917
558.115 (a) amended................................................47963
558.120 (d)(1)(iii)(b) amended.....................................46706
558.128 (a) revised; (d)(1) table and (2) amended..................46706
    (a)(1) and (d)(1) table amended................................47963
558.140 (a) amended................................................46706
558.145 (a)(1) and (2) amended.....................................46706
558.155 (a)(1) and (2) amended.....................................46706
558.195 (d) table amended...........................................1833
    (d) table amended..............................................46706
558.198 (d)(1)(iii) table amended..................................47962
    (d)(1)(iv) table and (v) table amended.........................47963
    (b) and (d)(1) amended; (d)(2) added...........................62917
558.248 (a)(1), (2) and (d)(1) table amended.......................14074
558.258 (a) amended................................................47962
    Revised........................................................58935
558.265 (a) amended................................................47962
558.274 (a)(5) removed; (a)(7), (c)(1)(i) and (ii) amended.........22118
    (a)(2), (4) and (c)(1) table amended; (a)(3) removed...........23589
558.305 (a) amended................................................46706
558.311 (e)(1) table amended.......................................29020
    (e)(1) table amended...........................................46371
    (b) and (e) amended............................................46706
    (d)(7) added; (e)(1) table, (2)(iv) and (3)(iv) amended; 
(e)(1)(ix), (xii), (2)(iii) and (3)(iii) revised...................47076
    (b)(2) and (e)(1)(xv) amended..................................47963
558.340 (a) amended................................................46706
558.355 (f)(7) amended..............................................1834
    (f)(4)(ii), (iii) and (iv) redesignated as (f)(4)(iv), (vi) 
and (vii); (f)(1)(xxix), (xxx), (4)(ii), (iii) and (v) added.......13237
    (f)(3)(xii) added..............................................13238
    (f)(3)(ii)(b) amended..........................................16126
    (b)(8), (9), (f)(1)(iv)(b), (v)(b), (xiv)(b), (xv)(b) and 
(xvi)(b) amended...................................................46706
    (b)(5), (12), (f)(1)(xiii)(b), (xx)(b), (xxi)(b), (xxii)(b) 
and (2)(iv)(b) amended.............................................47963
    (b)(10), (f)(2)(v)(b), (vi)(b) amended.........................47962
    (f)(3)(v)(a) revised...........................................63500

[[Page 579]]

558.360 (a) amended................................................47963
558.363 (d)(1)(xii) added..........................................27022
    (a)(7) and (d)(1)(x)(B) amended................................46706
    (a)(4), (5), (d)(1)(vii)(B), (xii)(B) amended..................47962
558.365 (d)(1)(ii) and (iii) removed; (d)(1)(i)((a) and (b) 
        redesignated as new (d)(1)(ii) and (iii)...................45167
558.366 (c) table amended...................................46706, 47962
    (a) revised; (b) and (c) redesignated as (c) and (d); new (b) 
added; (d) table amended...........................................63500
558.435 (a) amended................................................47963
558.450 (a)(1), (d)(1) table and (2) table amended.................32740
    (d)(1) Table 1 amended.........................................47963
    (d)(1)(iv) table and (vi) table amended........................45167
558.460 (b) amended................................................47963
558.465 (a) amended................................................47963
558.485 (a), (b) and (d)(1) revised................................47963
558.500 (d)(1) revised.............................................21284
558.515 (a) and (d) amended........................................46706
    (d) table amended..............................................47963
558.550 (a)(1), (d)(1) and (3) amended; (a)(3) removed.............46707
    (d)(1)(x)(c) and (xii)(c) amended..............................47964
    (a)(2), (d)(1)(xv)(c) and (xvi)(c) amended.....................47962
558.555 (a) revised; (c) removed; (b) redesignated as new (c); new 
        (b) added; (d) amended.....................................47964
558.575 (a)(1) and (2) amended.....................................46707
558.582 (a) amended................................................46707
558.600 (c)(4)(ii) amended.........................................46707
558.625 (f)(2)(i) through (v) redesignated as (f)(2)(ii) through 
        (vi); new (f)(2)(i) added...................................1834
    (b)(39) amended................................................14074
    (c) added......................................................16126
    (f)(2)(vii) added..............................................21284
    (b)(2), (13) and (73) removed..................................22117
    (b)(16), (19) and (34) removed; (b)(79) amended................22118
    (b)(17) removed................................................23589
    (b)(9) removed.................................................36162
    (b)(25) amended................................................47964
558.630 (b)(8) amended.............................................22118
    (b)(4) removed; (b)(10) amended................................23589
    (b)(10) amended................................................36162
558.635 (a)(1) amended.............................................47964
579.22 Heading, introductory text and (b) revised..................18540

                                  2002

21 CFR
                                                                   67 FR
                                                                    Page
Chapter I
500.80 (a) amended.................................................78174
500.82 (b) amended.................................................78174
500.84 Heading and (c)(2) revised; (c)(1) amended; (c)(3) added....78174
500.88 (b) and (c) revised.........................................78174
510.88b (c) amended................................................67521
510.88f (b) amended................................................67521
510.300 Removed; interim............................................5056
    Regulation at 67 FR 5056 eff. date delayed.....................49568
510.302 Removed; interim............................................5057
    Regulation at 67 FR 5057 eff. date delayed.....................49568
510.455 OMB number..................................................9586
510.600 (c)(1) table amended.......................................13717
    (c)(1) table and (c)(2) table amended....17283, 41824, 42717, 42997, 
         43247, 45900, 50802, 51079, 51080, 63055, 67520, 67521, 72366, 
                                                     78354, 78355, 78684
514 Authority citation revised......................................5057
    Regulation at 67 FR 5057 eff. date delayed.....................49568
514.1 OMB number....................................................9586
514.3 Added; interim................................................5057
    Regulation at 67 FR 5057 eff. date delayed.....................49568
514.8 (a)(1), (5), and (ix) amended; (a)(6) revised; interim........5057
    Regulation at 67 FR 5057 eff. date delayed.....................49568
514.11 (a) amended; interim.........................................5057
    Regulation at 67 FR 5057 eff. date delayed.....................49568
514.15 (b) amended; interim.........................................5057
    Regulation at 67 FR 5057 eff. date delayed.....................49568
514.80 Added; interim...............................................5057
    Regulation at 67 FR 5057 eff. date delayed.....................49568
520.44 (b) amended.................................................78355
520.88b (c) amended................................................67521
520.88f (b) amended................................................67571
520.154c (b) amended...............................................78355
520.309 (a) amended; (d)(1) revised.................................6866
    (a), (b) and (d) revised.......................................65038
    (b), (d)(1) and (2) revised....................................65697

[[Page 580]]

520.445a (b) amended...............................................78355
520.445b (b) amended...............................................78355
520.445c (b) amended...............................................78355
520.446 Revised....................................................54954
520.447 Revised....................................................54954
    (b)(2) amended.................................................78684
520.530 (b) amended................................................78355
520.531 (b) amended................................................78355
520.538 Added......................................................68760
520.580 (b)(1) amended.............................................43248
520.905b (c) redesignated as (d); new (c) added; (d)(1)(iii) and 
        (2)(iii) amended; (a), (d)(1)(i), (2)(i) and (3)(i) 
        revised....................................................47450
520.955 Added......................................................78357
520.1192 (b)(2) amended............................................71820
520.1193 Revised...................................................11230
    (b)(2) amended.................................................21996
520.1194 Removed...................................................50597
520.1195 Revised...................................................50597
520.1196 Heading and (b) amended...................................21996
520.1242a (b)(1) amended...........................................63055
520.1242b (c) amended..............................................63055
520.1242c (b) amended..............................................63055
520.1242e (b) amended..............................................63055
520.1242f (b) amended..............................................63055
520.1263c (a), (b) and (d) revised.................................17284
    (d)(1)(iii) amended.....................................71819, 78356
520.1380 (c) amended...............................................67521
520.1484 (a) and (b) revised.......................................72366
    (b)(1) and (2) amended.........................................78971
520.1660d (a)(6), (d)(1)(ii)(A)(3), (B)(3), (C)(3) and (iii)(C) 
        amended.....................................................5469
520.1660d (d)(1)(iii)(C) amended...................................51081
520.1720a (b)(3) amended...........................................67521
520.2041 (b) amended...............................................21996
520.2043 Revised...................................................43248
520.2184 (b) amended...............................................78355
520.2240a (c) amended..............................................78355
520.2240b (c) amended..............................................78355
520.2260a (a)(1) amended...........................................78355
520.2261a (a) amended..............................................78355
520.2261b (a) amended..............................................78355
520.2345c (b) amended..............................................78355
520.2345d (a)(3), (d)(1)(iii) and (2)(iii) amended.................78355
522.234 (b) amended................................................63055
522.314 Heading, (a), (d)(1)(i), (iii) and (2) revised.............45901
522.522 Added......................................................78972
522.690 Revised....................................................41824
522.775 (b) amended................................................67521
522.940 (c)(1) amended.............................................78355
522.955 Section heading, (a), (d)(1)(i), (ii) and (iii) revised.....6866
522.970 (d) redesignated as (e); new (d) added; (a), (b), new 
        (e)(1)(i), (iii), (2)(i) and (iii) revised..................9400
522.1010 (b)(3) amended............................................18086
522.1066 (b) amended...............................................67521
522.1078 Revised...................................................68759
522.1085 (b) amended...............................................67521
522.1222a Revised..................................................17283
522.1244 (b) amended...............................................63055
522.1260 Heading, (a), (b), (e)(1)(i), (iii), (2)(i) and (iii) 
        revised....................................................34388
522.1380 (b) amended...............................................67521
522.1451 (d)(2) amended............................................57944
522.1660 (d)(1)(iii) amended..................12471, 47451, 72366, 78357
    (b), (d)(1)(iii) and (2)(iii) amended..........................72367
522.1720 (b)(1) amended............................................67521
522.1870 (b) amended...............................................79853
522.2112 (c) removed; (d) redesignated as (c); heading, (a) and 
        new (c) revised............................................18085
522.2240 (c) amended...............................................78355
522.2260 (b) amended...............................................78355
522.2470 (b) amended...............................................67521
522.2471 Revised...................................................72367
522.2477 (d)(2)(i)(C) added.........................................5724
    (b)(1) amended.................................................78358
522.2478 Revised...................................................78972
522.2680 (a), (d)(1)(i), (2)(i), (3)(i) and (ii) revised; (d)(4) 
        added.......................................................6867
524.402 Revised.....................................................8860
524.1140 Added.....................................................78685
524.1240 (b) amended...............................................78355
524.1600a (b) amended..............................................67521
529.40 Added........................................................7072
529.1940 Added.....................................................41824
    (b) amended....................................................51080
530.41 (a)(7) and (8) amended.......................................5471
556.169 Added......................................................78973
556.283 (b) revised................................................78357
556.735 (b) revised................................................72368
556.760 (a) and (b) redesignated as (b)(1) and (2); new (b)(1) 
        revised; (a) added..........................................6867
558 Technical correction...........................................44931
558.4 (d) amended..................................................47692
558.76 (d)(3)(xii) amended.........................................30327
    (d)(3)(v) through (xvii) redesignated as (d)(3)(vi) through 
(xviii); new (d)(3)(v) added.......................................34830
558.78 (a)(2) amended..............................................71821

[[Page 581]]

558.128 (a), (b) and (d) redesignated as (b), (c) and (e); new (a) 
        and (d) added; new (b) and (e) revised.....................43249
558.155 Amended....................................................21171
558.195 (d) table amended..........................................36098
    Revised........................................................72370
558.198 (a) revised; (b) and (d)(1)(iii) through (v) redesignated 
        as (c) and (d)(1)(v) through (vii); new (b), (d)(1)(iii) 
        and (iv) added.............................................34830
    (d)(2)(ii) added...............................................47257
    (d)(2)(iii) and (iv) added.....................................48549
558.311 (b)(8) and (e)(1)(xviii) added; (d)(7) amended; 
        (e)(1)(xii) revised........................................72368
558.315 (a) amended................................................63055
558.325 (a) and (b) amended; (a)(1), (5), (13) and (d) revised.....36513
558.342 (b), (c) and (d) redesignated as (c), (d) and (e); 
        heading, (a) and new (e) revised; new (b), (d)(3) and (8) 
        added......................................................47688
558.355 (f)(3)(iv) removed; (f)(7) revised.........................47691
558.366 (d) table amended..........................................30327
558.450 (d)(1)(ix) table amended...................................51081
558.485 (b)(7) amended.............................................51080
558.500 (a) amended; (d)(1) table revised..........................47692
    Revised........................................................71820
558.515 (d) table amended..........................................30546
558.530 (d)(5)(x) revised..........................................34831
558.550 (d)(1)(xx)(ii) added.......................................72369
558.600 Revised.....................................................7268
558.618 (a) through (d) redesignated as (b) through (e); new (a) 
        added; new (b), (c) and (e)(3) revised.....................21997
558.625(f)(2)(viii) added..........................................72370
558.680 (a), (b) and (c) redesignated as (b), (c) and (d); new (a) 
        added; new (b) revised; (d)(1) table amended................6868
573.920 (h) revised................................................46851

                                  2003

   (Regulations published from January 1, 2003, through April 1, 2003)

21 CFR
                                                                   68 FR
                                                                    Page
Chapter I
510.300 Regulation at 67 FR 5056 withdrawn.........................15355
    Removed; eff. 6-30-03..........................................15364
510.302 Regulation at 67 FR 5057 withdrawn.........................15355
    Removed; eff. 6-30-03..........................................15365
510.600 (c)(1) table and (c)(2) table amended....1161, 4712, 4914, 4916, 
                                                            13226, 15369
514 Regulation at 67 FR 5057 withdrawn.............................15355
    Authority citation revised.....................................15365
514.3 Regulation at 67 FR 5057 withdrawn...........................15355
    Added; eff. 6-30-03............................................15365
514.8 Regulation at 67 FR 5057 withdrawn...........................15355
    (a)(1) and (5) amended; (a)(6) revised; eff. 6-30-03...........15365
514.11 Regulation at 67 FR 5057 withdrawn..........................15355
    (a) amended; eff. 6-30-03......................................15365
514.15 Regulation at 67 FR 5057 withdrawn..........................15355
    (b) amended; eff. 6-30-03......................................15365
514.80 Regulation at 67 FR 5057 withdrawn..........................15355
    Added; eff. 6-30-03............................................15365
520.390a (b)(2) amended.............................................4914
520.540b (b)(2) amended.............................................4914
520.622a (a)(3) amended.............................................4914
520.823 (b) amended.................................................4914
520.1242a (b)(4) added..............................................4916
520.1263c (b) amended...............................................3817
520.1484 (b)(2) amended.............................................4914
520.1660d (b)(7) amended............................................4914
520.1696b (b) amended...............................................4914
520.1720a (b)(3) amended............................................4914
520.1720d (b) amended...............................................4915
520.2044 (a) and (b) revised.......................................13627
520.2123a (b) amended...............................................4915
520.2123b (b) amended...............................................4915
520.2260b (c)(1) and (e)(1) amended.................................4915
522.820 (a) amended.................................................4915
522.1660 (d)(1)(iii) amended........................................8153
522.2444b (b) amended...............................................4915
524.1044h (a) and (c)(1) amended; (c)(2) revised...................15370
524.1193 (b) amended..........................................3817, 4713
524.1580b (b) amended...............................................4915
524.2482 Added......................................................4916
526.820 (b) amended.................................................4915
529.1030 Heading, (a), (b)(1), (2), (d)(2)(i) table and (iv) 
        amended; (b) introductory text revised......................5563
530.41 (a)(12) added; eff. 5-29-03..................................9530
    (a)(12) corrected..............................................14134

[[Page 582]]

558.128 (e)(6)(vii) through (e)(6)(xii) redesignated as 
        (e)(6)(viii) through (e)(6)(xiii); new (e)(6)(vii) added 
                                                                   13839
558.195(e)(2) corrected............................................15372
558.248 (a)(1), (2) and (d)(1) table amended........................4915
558.305 Heading, (a), and (d) revised; (b) redesignated as (c); 
        new (b) and (c)(3) added...................................13839
558.311 (e)(1)(iv) table and (x) table amended.....................15371
558.355 (d)(6) amended.............................................15371
558.550 (a)(2) amended..............................................6820
558.625 (b)(39) table amended.......................................4915
588.195 (e)(2) table corrected.....................................15372


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