[Title 21 CFR ]
[Code of Federal Regulations (annual edition) - April 1, 2014 Edition]
[From the U.S. Government Publishing Office]



[[Page i]]

          

          Title 21

Food and Drugs


________________________

Part 1300 to End

                         Revised as of April 1, 2014

          Containing a codification of documents of general 
          applicability and future effect

          As of April 1, 2014
                    Published by the Office of the Federal Register 
                    National Archives and Records Administration as a 
                    Special Edition of the Federal Register

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                            Table of Contents



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

  Title 21:
          Chapter II--Drug Enforcement Administration, 
          Department of Justice                                      3
          Chapter III--Office of National Drug Control Policy      245
  Finding Aids:
      Table of CFR Titles and Chapters........................     317
      Alphabetical List of Agencies Appearing in the CFR......     337
      List of CFR Sections Affected...........................     347

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

                     Cite this Code: CFR
                     To cite the regulations in 
                       this volume use title, 
                       part and section number. 
                       Thus, 21 CFR 1300.01 
                       refers to title 21, part 
                       1300, section 01.

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

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                               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, 2014), 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 
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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.

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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 
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PAST PROVISIONS OF THE CODE

    Provisions of the Code that are no longer in force and effect as of 
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Code users may find the text of provisions in effect on any given date 
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previous annual editions of the LSA. For changes to the Code prior to 
2001, consult the List of CFR Sections Affected compilations, published 
for 1949-1963, 1964-1972, 1973-1985, and 1986-2000.

``[RESERVED]'' TERMINOLOGY

    The term ``[Reserved]'' is used as a place holder within the Code of 
Federal Regulations. An agency may add regulatory information at a 
``[Reserved]'' location at any time. Occasionally ``[Reserved]'' is used 
editorially to indicate that a portion of the CFR was left vacant and 
not accidentally dropped due to a printing or computer error.

INCORPORATION BY REFERENCE

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established by statute and allows Federal agencies to meet the 
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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 
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    (c) The incorporating document is drafted and submitted for 
publication in accordance with 1 CFR part 51.
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CFR INDEXES AND TABULAR GUIDES

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separate volume, revised annually as of January 1, entitled CFR Index 
and Finding Aids. This volume contains the Parallel Table of Authorities 
and Rules. A list of CFR titles, chapters, subchapters, and parts and an 
alphabetical list of agencies publishing in the CFR are also included in 
this volume.

[[Page vii]]

    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 
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    A List of CFR Sections Affected (LSA) is published monthly, keyed to 
the revision dates of the 50 CFR titles.

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in the Code of Federal Regulations.

INQUIRIES

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or write to the Director, Office of the Federal Register, National 
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    The e-CFR is a regularly updated, unofficial editorial compilation 
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of the Federal Register and the Government Printing Office. It is 
available at www.ecfr.gov.

    Charles A. Barth,
    Director,
    Office of the Federal Register.
    April 1, 2014.







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                               THIS TITLE

    Title 21--Food and Drugs is composed of nine volumes. The parts in 
these volumes are arranged in the following order: Parts 1-99, 100-169, 
170-199, 200-299, 300-499, 500-599, 600-799, 800-1299 and 1300 to end. 
The first eight volumes, containing parts 1-1299, comprise Chapter I--
Food and Drug Administration, Department of Health and Human Services. 
The ninth volume, containing part 1300 to end, includes Chapter II--Drug 
Enforcement Administration, Department of Justice, and Chapter III--
Office of National Drug Control Policy. The contents of these volumes 
represent all current regulations codified under this title of the CFR 
as of April 1, 2014.

    For this volume, Michele Bugenhagen was Chief Editor. The Code of 
Federal Regulations publication program is under the direction of the 
Managing Editor, assisted by Ann Worley.

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                         TITLE 21-FOOD AND DRUGS




                  (This book contains part 1300 to End)

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

chapter ii--Drug Enforcement Administration, Department of 
  Justice...................................................        1301

chapter iii--Office of National Drug Control Policy.........        1401

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   CHAPTER II--DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE




  --------------------------------------------------------------------
Part                                                                Page
1300            Definitions.................................           5
1301            Registration of manufacturers, distributors, 
                    and dispensers of controlled substances.          21
1302            Labeling and packaging requirements for 
                    controlled substances...................          54
1303            Quotas......................................          56
1304            Records and reports of registrants..........          64
1305            Orders for schedule I and II controlled 
                    substances..............................          82
1306            Prescriptions...............................          90
1307            Miscellaneous...............................         102
1308            Schedules of controlled substances..........         105
1309            Registration of manufacturers, distributors, 
                    importers and exporters of list I 
                    chemicals...............................         129
1310            Records and reports of listed chemicals and 
                    certain machines........................         140
1311            Requirements for electronic orders and 
                    prescriptions...........................         164
1312            Importation and exportation of controlled 
                    substances..............................         185
1313            Importation and exportation of list I and 
                    list II chemicals.......................         199
1314            Retail sale of scheduled listed chemical 
                    products................................         210
1315            Importation and production quotas for 
                    ephedrine, pseudoephedrine, and 
                    phenylpropanolamine.....................         218
1316            Administrative functions, practices, and 
                    procedures..............................         228
1321            DEA Mailing addresses.......................         241
1322-1399

 [Reserved]

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PART 1300_DEFINITIONS--Table of Contents



Sec.
1300.01 Definitions relating to controlled substances.
1300.02 Definitions relating to listed chemicals.
1300.03 Definitions relating to electronic orders for controlled 
          substances and electronic prescriptions for controlled 
          substances.
1300.04 Definitions relating to the dispensing of controlled substances 
          by means of the Internet.

    Authority: 21 U.S.C. 802, 821, 829, 871(b), 951, 958(f).

    Source: 62 FR 13941, Mar. 24, 1997, unless otherwise noted.



Sec. 1300.01  Definitions relating to controlled substances.

    (a) Any term not defined in this part shall have the definition set 
forth in section 102 of the Act (21 U.S.C. 802), except that certain 
terms used in part 1316 of this chapter are defined at the beginning of 
each subpart of that part.
    (b) As used in parts 1301 through 1308 and part 1312 of this 
chapter, the following terms shall have the meanings specified:
    Act means the Controlled Substances Act, as amended (84 Stat. 1242; 
21 U.S.C. 801) and/or the Controlled Substances Import and Export Act, 
as amended (84 Stat. 1285; 21 U.S.C. 951).
    Administration means the Drug Enforcement Administration.
    Administrator means the Administrator of the Drug Enforcement 
Administration. The Administrator has been delegated authority under the 
Act by the Attorney General (28 CFR 0.100).
    Anabolic steroid means any drug or hormonal substance, chemically 
and pharmacologically related to testosterone (other than estrogens, 
progestins, corticosteroids, and dehydroepiandrosterone), and includes:

(1) 3[beta],17-dihydroxy-5a-androstane
(2) 3[alpha],17[beta]-dihydroxy-5a-androstane
(3) 5[alpha]-androstan-3,17-dione
(4) 1-androstenediol (3[beta],17[beta]-dihydroxy-5[alpha]-androst-1-ene)
(5) 1-androstenediol (3[alpha],17[beta]-dihydroxy-5[alpha]-androst-1-
ene)
(6) 4-androstenediol (3[beta],17[beta]-dihydroxy-androst-4-ene)
(7) 5-androstenediol (3[beta],17[beta]-dihydroxy-androst-5-ene)
(8) 1-androstenedione ([5[alpha]]-androst-1-en-3,17-dione)
(9) 4-androstenedione (androst-4-en-3,17-dione)
(10) 5-androstenedione (androst-5-en-3,17-dione)
(11) bolasterone (7[alpha],17[alpha]-dimethyl-17[beta]-hydroxyandrost-4-
en-3-one)
(12) boldenone (17[beta]-hydroxyandrost-1,4-diene-3-one)
(13) boldione (androsta-1,4-diene-3,17-dione)
(14) calusterone (7[beta],17[alpha]-dimethyl-17[beta]-hydroxyandrost-4-
en-3-one)
(15) clostebol (4-chloro-17[beta]-hydroxyandrost-4-en-3-one)
(16) dehydrochloromethyltestosterone (4-chloro-17[beta]-hydroxy-
17[alpha]-methyl-androst-1,4-dien-3-one)
(17) desoxymethyltestosterone (17[alpha]-methyl-5[alpha]-androst-2-en-
17[beta]-ol) (a.k.a. `madol`)
(18) [Delta]1-dihydrotestosterone (a.k.a.`1-testosterone`) (17[beta]-
hydroxy-5[alpha]-androst-1-en-3-one)
(19) 4-dihydrotestosterone (17[beta]-hydroxy-androstan-3-one)
(20) drostanolone (17[beta]-hydroxy-2[alpha]-methyl-5[alpha]-androstan-
3-one)
(21) ethylestrenol (17[alpha]-ethyl-17[beta]-hydroxyestr-4-ene)
(22) fluoxymesterone (9-fluoro-17[alpha]-methyl-11[beta],17[beta]-
dihydroxyandrost-4-en-3-one)
(23) formebolone (2-formyl-17[alpha]-methyl-11[alpha],17[beta]-
dihydroxyandrost-1,4-dien-3-one)
(24) furazabol (17[alpha]-methyl-17[beta]-hydroxyandrostano[2,3-c]-
furazan)
(25) 13[beta]-ethyl-17[beta]-hydroxygon-4-en-3-one
(26) 4-hydroxytestosterone (4,17[beta]-dihydroxy-androst-4-en-3-one)
(27) 4-hydroxy-19-nortestosterone (4,17[beta]-dihydroxy-estr-4-en-3-one)
(28) mestanolone (17[alpha]-methyl-17[beta]-hydroxy-5-androstan-3-one)
(29) mesterolone (1[alpha]-methyl-17[beta]-hydroxy-[5[alpha]]-androstan-
3-one)
(30) methandienone (17[alpha]-methyl-17[beta]-hydroxyandrost-1,4-dien-3-
one)
(31) methandriol (17[alpha]-methyl-3[beta],17[beta]-dihydroxyandrost-5-
ene)
(32) Methasterone (2[alpha],17[alpha]-dimethyl-5[alpha]-androstan-
17[beta]-ol-3-one)
(33) methenolone (1-methyl-17[beta]-hydroxy-5[alpha]-androst-1-en-3-one)
(34) 17[alpha]-methyl-3[beta],17[beta]-dihydroxy-5a-androstane

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(35) 17[alpha]-methyl-3[alpha],17[beta]-dihydroxy-5a-androstane
(36) 17[alpha]-methyl-3[beta],17[beta]-dihydroxyandrost-4-ene
(37) 17[alpha]-methyl-4-hydroxynandrolone (17[alpha]-methyl-4-hydroxy-
17[beta]-hydroxyestr-4-en-3-one)
(38) methyldienolone (17[alpha]-methyl-17[beta]-hydroxyestra-4,9(10)-
dien-3-one)
(39) methyltrienolone (17[alpha]-methyl-17[beta]-hydroxyestra-4,9,11-
trien-3-one)
(40) methyltestosterone (17[alpha]-methyl-17[beta]-hydroxyandrost-4-en-
3-one)
(41) mibolerone (7[alpha],17[alpha]-dimethyl-17[beta]-hydroxyestr-4-en-
3-one)
(42) 17[alpha]-methyl-[Delta]1-dihydrotestosterone (17[beta]-hydroxy-
17[alpha]-methyl-5[alpha]-androst-1-en-3-one) (a.k.a. `17-[alpha]-
methyl-1-testosterone`)
(43) nandrolone (17[beta]-hydroxyestr-4-en-3-one)
(44) 19-nor-4-androstenediol (3[beta], 17[beta]-dihydroxyestr-4-ene)
(45) 19-nor-4-androstenediol (3[alpha], 17[beta]-dihydroxyestr-4-ene)
(46) 19-nor-5-androstenediol (3[beta], 17[beta]-dihydroxyestr-5-ene)
(47) 19-nor-5-androstenediol (3[alpha], 17[beta]-dihydroxyestr-5-ene)
(48) 19-nor-4,9(10)-androstadienedione (estra-4,9(10)-diene-3,17-dione)
(49) 19-nor-4-androstenedione (estr-4-en-3,17-dione)
(50) 19-nor-5-androstenedione (estr-5-en-3,17-dione)
(51) norbolethone (13[beta], 17[alpha]-diethyl-17[beta]-hydroxygon-4-en-
3-one)
(52) norclostebol (4-chloro-17[beta]-hydroxyestr-4-en-3-one)
(53) norethandrolone (17[alpha]-ethyl-17[beta]-hydroxyestr-4-en-3-one)
(54) normethandrolone (17[alpha]-methyl-17[beta]-hydroxyestr-4-en-3-one)
(55) oxandrolone (17[alpha]-methyl-17[beta]-hydroxy-2-oxa-[5[alpha]]-
androstan-3-one)
(56) oxymesterone (17[alpha]-methyl-4,17[beta]-dihydroxyandrost-4-en-3-
one)
(57) oxymetholone (17[alpha]-methyl-2-hydroxymethylene-17[beta]-hydroxy-
[5[alpha]]-androstan-3-one)
(58) Prostanozol (17[beta]-hydroxy-5[alpha]-androstano[3,2-c]pyrazole)
(59) stanozolol (17[alpha]-methyl-17[beta]-hydroxy-[5[alpha]]-androst-2-
eno[3,2-c]-pyrazole)
(60) stenbolone (17[beta]-hydroxy-2-methyl-[5[alpha]]-androst-1-en-3-
one)
(61) testolactone (13-hydroxy-3-oxo-13,17-secoandrosta-1,4-dien-17-oic 
acid lactone)
(62) testosterone (17[beta]-hydroxyandrost-4-en-3-one)
(63) tetrahydrogestrinone (13[beta], 17[alpha]-diethyl-17[beta]-
hydroxygon-4,9,11-trien-3-one)
(64) trenbolone (17[beta]-hydroxyestr-4,9,11-trien-3-one)
(65) Any salt, ester, or ether of a drug or substance described in this 
paragraph. Except such term does not include an anabolic steroid that is 
expressly intended for administration through implants to cattle or 
other nonhuman species and that has been approved by the Secretary of 
Health and Human Services for such administration. If any person 
prescribes, dispenses, or distributes such steroid for human use, the 
person shall be considered to have prescribed, dispensed, or distributed 
an anabolic steroid within the meaning of this paragraph.

    Automated dispensing system means a mechanical system that performs 
operations or activities, other than compounding or administration, 
relative to the storage, packaging, counting, labeling, and dispensing 
of medications, and which collects, controls, and maintains all 
transaction information.
    Basic class means, as to controlled substances listed in Schedules I 
and II:
    (1) Each of the opiates, including its isomers, esters, ethers, 
salts, and salts of isomers, esters, and ethers whenever the existence 
of such isomers, esters, ethers, and salts is possible within the 
specific chemical designation, listed in Sec. 1308.11(b) of this 
chapter;
    (2) Each of the opium derivatives, including its salts, isomers, and 
salts of isomers whenever the existence of such salts, isomers, and 
salts of isomers is possible within the specific chemical designation, 
listed in Sec. 1308.11(c) of this chapter;
    (3) Each of the hallucinogenic substances, including its salts, 
isomers, and salts of isomers whenever the existence of such salts, 
isomers, and salts of isomers is possible within the specific chemical 
designation, listed in Sec. 1308.11(d) of this chapter;
    (4) Each of the following substances, whether produced directly or 
indirectly

[[Page 7]]

by extraction from substances of vegetable origin, or independently by 
means of chemical synthesis, or by a combination of extraction and 
chemical synthesis:
    (i) Opium, including raw opium, opium extracts, opium fluid 
extracts, powdered opium, granulated opium, deodorized opium and 
tincture of opium;
    (ii) Apomorphine;
    (iii) Codeine;
    (iv) Etorphine hydrochloride;
    (v) Ethylmorphine;
    (vi) Hydrocodone;
    (vii) Hydromorphone;
    (viii) Metopon;
    (ix) Morphine;
    (x) Oxycodone;
    (xi) Oxymorphone;
    (xii) Thebaine;
    (xiii) Mixed alkaloids of opium listed in Sec. 1308.12(b)(2) of 
this chapter;
    (xiv) Cocaine; and
    (xv) Ecgonine;
    (5) Each of the opiates, including its isomers, esters, ethers, 
salts, and salts of isomers, esters, and ethers whenever the existence 
of such isomers, esters, ethers, and salts is possible within the 
specific chemical designation, listed in Sec. 1308.12(c) of this 
chapter; and
    (6) Methamphetamine, its salts, isomers, and salts of its isomers;
    (7) Amphetamine, its salts, optical isomers, and salts of its 
optical isomers;
    (8) Phenmetrazine and its salts;
    (9) Methylphenidate;
    (10) Each of the substances having a depressant effect on the 
central nervous system, including its salts, isomers, and salts of 
isomers whenever the existence of such salts, isomers, and salts of 
isomers is possible within the specific chemical designation, listed in 
Sec. 1308.12(e) of this chapter.
    Central fill pharmacy means a pharmacy which is permitted by the 
state in which it is located to prepare controlled substances orders for 
dispensing pursuant to a valid prescription transmitted to it by a 
registered retail pharmacy and to return the labeled and filled 
prescriptions to the retail pharmacy for delivery to the ultimate user. 
Such central fill pharmacy shall be deemed ``authorized'' to fill 
prescriptions on behalf of a retail pharmacy only if the retail pharmacy 
and central fill pharmacy have a contractual relationship providing for 
such activities or share a common owner.
    Commercial container means any bottle, jar, tube, ampule, or other 
receptacle in which a substance is held for distribution or dispensing 
to an ultimate user, and in addition, any box or package in which the 
receptacle is held for distribution or dispensing to an ultimate user. 
The term commercial container does not include any package liner, 
package insert or other material kept with or within a commercial 
container, nor any carton, crate, drum, or other package in which 
commercial containers are stored or are used for shipment of controlled 
substances.
    Compounder means any person engaging in maintenance or 
detoxification treatment who also mixes, prepares, packages or changes 
the dosage form of a narcotic drug listed in Schedules II, III, IV or V 
for use in maintenance or detoxification treatment by another narcotic 
treatment program.
    Controlled substance has the meaning given in section 802(6) of 
Title 21, United States Code (U.S.C.).
    Customs territory of the United States means the several States, the 
District of Columbia, and Puerto Rico.
    Detoxification treatment means the dispensing, for a period of time 
as specified below, of a narcotic drug or narcotic drugs in decreasing 
doses to an individual to alleviate adverse physiological or 
psychological effects incident to withdrawal from the continuous or 
sustained use of a narcotic drug and as a method of bringing the 
individual to a narcotic drug-free state within such period of time. 
There are two types of detoxification treatment: Short-term 
detoxification treatment and long-term detoxification treatment.
    (1) Short-term detoxification treatment is for a period not in 
excess of 30 days.
    (2) Long-term detoxification treatment is for a period more than 30 
days but not in excess of 180 days.
    Dispenser means an individual practitioner, institutional 
practitioner, pharmacy or pharmacist who dispenses a controlled 
substance.
    Export means, with respect to any article, any taking out or removal 
of

[[Page 8]]

such article from the jurisdiction of the United States (whether or not 
such taking out or removal constitutes an exportation within the meaning 
of the customs and related laws of the United States).
    Exporter includes every person who exports, or who acts as an export 
broker for exportation of, controlled substances listed in any schedule.
    Freight forwarding facility means a separate facility operated by a 
distributing registrant through which sealed, packaged controlled 
substances in unmarked shipping containers (i.e., the containers do not 
indicate that the contents include controlled substances) are, in the 
course of delivery to, or return from, customers, transferred in less 
than 24 hours. A distributing registrant who operates a freight 
forwarding facility may use the facility to transfer controlled 
substances from any location the distributing registrant operates that 
is registered with the Administration to manufacture, distribute, or 
import controlled substances, or, with respect to returns, registered to 
dispense controlled substances, provided that the notice required by 
Sec. 1301.12(b)(4) of Part 1301 of this chapter has been submitted and 
approved. For purposes of this definition, a ``distributing registrant'' 
is a person who is registered with the Administration as a manufacturer, 
distributor, and/or importer.
    Hearing means:
    (1) In part 1301 of this chapter, any hearing held for the granting, 
denial, revocation, or suspension of a registration pursuant to sections 
303, 304, and 1008 of the Act (21 U.S.C. 823, 824 and 958).
    (2) In part 1303 of this chapter, any hearing held regarding the 
determination of aggregate production quota or the issuance, adjustment, 
suspension, or denial of a procurement quota or an individual 
manufacturing quota.
    (3) In part 1308 of this chapter, any hearing held for the issuance, 
amendment, or repeal of any rule issuable pursuant to section 201 of the 
Act (21 U.S.C. 811).
    Import means, with respect to any article, any bringing in or 
introduction of such article into either the jurisdiction of the United 
States or the customs territory of the United States, and from the 
jurisdiction of the United States into the customs territory of the 
United States (whether or not such bringing in or introduction 
constitutes an importation within the meaning of the tariff laws of the 
United States).
    Importer includes every person who imports, or who acts as an import 
broker for importation of, controlled substances listed in any schedule.
    Individual practitioner means a physician, dentist, veterinarian, or 
other individual licensed, registered, or otherwise permitted, by the 
United States or the jurisdiction in which he/she practices, to dispense 
a controlled substance in the course of professional practice, but does 
not include a pharmacist, a pharmacy, or an institutional practitioner.
    Institutional practitioner means a hospital or other person (other 
than an individual) licensed, registered, or otherwise permitted, by the 
United States or the jurisdiction in which it practices, to dispense a 
controlled substance in the course of professional practice, but does 
not include a pharmacy.
    Interested person means any person adversely affected or aggrieved 
by any rule or proposed rule issuable pursuant to section 201 of the Act 
(21 U.S.C. 811).
    Inventory means all factory and branch stocks in finished form of a 
basic class of controlled substance manufactured or otherwise acquired 
by a registrant, whether in bulk, commercial containers, or contained in 
pharmaceutical preparations in the possession of the registrant 
(including stocks held by the registrant under separate registration as 
a manufacturer, importer, exporter, or distributor).
    Isomer means:
    (1) The optical isomer, except as used in Sec. 1308.11(d) and Sec. 
1308.12(b)(4) of this chapter. As used in Sec. 1308.11(d) of this 
chapter, the term ``isomer'' means any optical, positional, or geometric 
isomer. As used in Sec. 1308.12(b)(4) of this chapter, the term 
``isomer'' means any optical or geometric isomer;
    (2) As used in Sec. 1308.11(d) of this chapter, the term 
``positional isomer'' means any substance possessing the same molecular 
formula and core structure and having the same functional group(s) and/
or substituent(s) as

[[Page 9]]

those found in the respective Schedule I hallucinogen, attached at any 
position(s) on the core structure, but in such manner that no new 
chemical functionalities are created and no existing chemical 
functionalities are destroyed relative to the respective Schedule I 
hallucinogen. Rearrangements of alkyl moieties within or between 
functional group(s) or substituent(s), or divisions or combinations of 
alkyl moieties, that do not create new chemical functionalities or 
destroy existing chemical functionalities, are allowed i.e., result in 
compounds which are positional isomers. For purposes of this definition, 
the ``core structure'' is the parent molecule that is the common basis 
for the class; for example, tryptamine, phenethylamine, or ergoline. 
Examples of rearrangements resulting in creation and/or destruction of 
chemical functionalities (and therefore resulting in compounds which are 
not positional isomers) include, but are not limited to: Ethoxy to 
alpha-hydroxyethyl, hydroxy and methyl to methoxy, or the repositioning 
of a phenolic or alcoholic hydroxy group to create a hydroxyamine. 
Examples of rearrangements resulting in compounds which would be 
positional isomers include: Tert-butyl to sec-butyl, methoxy and ethyl 
to isopropoxy, N,N-diethyl to N-methyl-N-propyl, or alpha-methylamino to 
N-methylamino.
    Jurisdiction of the United States means the customs territory of the 
United States, the Virgin Islands, the Canal Zone, Guam, American Samoa, 
and the Trust Territories of the Pacific Islands.
    Label means any display of written, printed, or graphic matter 
placed upon the commercial container of any controlled substance by any 
manufacturer of such substance.
    Labeling means all labels and other written, printed, or graphic 
matter:
    (1) Upon any controlled substance or any of its commercial 
containers or wrappers, or
    (2) Accompanying such controlled substance.
    Long Term Care Facility (LTCF) means a nursing home, retirement 
care, mental care or other facility or institution which provides 
extended health care to resident patients.
    Maintenance treatment means the dispensing for a period in excess of 
twenty-one days, of a narcotic drug or narcotic drugs in the treatment 
of an individual for dependence upon heroin or other morphine-like drug.
    Manufacture means the producing, preparation, propagation, 
compounding, or processing of a drug or other substance or the packaging 
or repackaging of such substance, or the labeling or relabeling of the 
commercial container of such substance, but does not include the 
activities of a practitioner who, as an incident to his/her 
administration or dispensing such substance in the course of his/her 
professional practice, prepares, compounds, packages or labels such 
substance.
    Manufacturer means a person who manufactures a drug or other 
substance, whether under a registration as a manufacturer or under 
authority of registration as a researcher or chemical analyst.
    Mid-level practitioner means an individual practitioner, other than 
a physician, dentist, veterinarian, or podiatrist, who is licensed, 
registered, or otherwise permitted by the United States or the 
jurisdiction in which he/she practices, to dispense a controlled 
substance in the course of professional practice. Examples of mid-level 
practitioners include, but are not limited to, health care providers 
such as nurse practitioners, nurse midwives, nurse anesthetists, 
clinical nurse specialists and physician assistants who are authorized 
to dispense controlled substances by the State in which they practice.
    Name means the official name, common or usual name, chemical name, 
or brand name of a substance.
    Narcotic drug means any of the following whether produced directly 
or indirectly by extraction from substances of vegetable origin or 
independently by means of chemical synthesis or by a combination of 
extraction and chemical synthesis:
    (1) Opium, opiates, derivatives of opium and opiates, including 
their isomers, esters, ethers, salts, and salts of isomers, esters, and 
ethers whenever the existence of such isomers, esters, ethers and salts 
is possible within the

[[Page 10]]

specific chemical designation. Such term does not include the 
isoquinoline alkaloids of opium.
    (2) Poppy straw and concentrate of poppy straw.
    (3) Coca leaves, except coca leaves and extracts of coca leaves from 
which cocaine, ecgonine and derivatives of ecgonine or their salts have 
been removed.
    (4) Cocaine, its salts, optical and geometric isomers, and salts of 
isomers.
    (5) Ecgonine, its derivatives, their salts, isomers and salts of 
isomers.
    (6) Any compound, mixture, or preparation which contains any 
quantity of any of the substances referred to in paragraphs (1) through 
(5) of this definition.
    Narcotic treatment program means a program engaged in maintenance 
and/or detoxification treatment with narcotic drugs.
    Net disposal means, for a stated period, the quantity of a basic 
class of controlled substance distributed by the registrant to another 
person, plus the quantity of that basic class used by the registrant in 
the production of (or converted by the registrant into) another basic 
class of controlled substance or a noncontrolled substance, plus the 
quantity of that basic class otherwise disposed of by the registrant, 
less the quantity of that basic class returned to the registrant by any 
purchaser, and less the quantity of that basic class distributed by the 
registrant to another registered manufacturer of that basic class for 
purposes other than use in the production of, or conversion into, 
another basic class of controlled substance or a noncontrolled substance 
or in the manufacture of dosage forms of that basic class.
    Person includes any individual, corporation, government or 
governmental subdivision or agency, business trust, partnership, 
association, or other legal entity.
    Pharmacist means any pharmacist licensed by a State to dispense 
controlled substances, and shall include any other person (e.g., 
pharmacist intern) authorized by a State to dispense controlled 
substances under the supervision of a pharmacist licensed by such State.
    Prescription means an order for medication which is dispensed to or 
for an ultimate user but does not include an order for medication which 
is dispensed for immediate administration to the ultimate user (e.g., an 
order to dispense a drug to a bed patient for immediate administration 
in a hospital is not a prescription).
    Proceeding means all actions taken for the issuance, amendment, or 
repeal of any rule issued pursuant to section 201 of the Act (21 U.S.C. 
811), commencing with the publication by the Administrator of the 
proposed rule, amended rule, or repeal in the Federal Register.
    Purchaser means any registered person entitled to obtain and execute 
order forms pursuant to Sec. Sec. 1305.04 and 1305.06.
    Readily retrievable means that certain records are kept by automatic 
data processing systems or other electronic or mechanized recordkeeping 
systems in such a manner that they can be separated out from all other 
records in a reasonable time and/or records are kept on which certain 
items are asterisked, redlined, or in some other manner visually 
identifiable apart from other items appearing on the records.
    Register and registration refer only to registration required and 
permitted by sections 303 or 1007 of the Act (21 U.S.C. 823 or 957).
    Registrant means any person who is registered pursuant to either 
section 303 or section 1008 of the Act (21 U.S.C. 823 or 958).
    Reverse distributor means a registrant who receives controlled 
substances acquired from another DEA registrant for the purpose of--
    (1) Returning unwanted, unusable, or outdated controlled substances 
to the manufacturer or the manufacturer's agent; or
    (2) Where necessary, processing such substances or arranging for 
processing such substances for disposal.

[[Page 11]]

    Supplier means any registered person entitled to fill order forms 
pursuant to Sec. 1305.06 of this chapter.

[62 FR 13941, Mar. 24, 1997, as amended at 65 FR 44678, July 19, 2000; 
68 FR 37409, June 24, 2003; 68 FR 41228, July 11, 2003; 70 FR 25465, May 
13, 2005; 70 FR 74656, Dec. 16, 2005; 71 FR 60427, Oct. 13, 2006; 72 FR 
67852, Dec. 3, 2007; 74 FR 63609, Dec. 4, 2009; 77 FR 4230, Jan. 27, 
2012; 77 FR 44461, July 30, 2012]



Sec. 1300.02  Definitions relating to listed chemicals.

    (a) Any term not defined in this part shall have the definition set 
forth in section 102 of the Act (21 U.S.C. 802), except that certain 
terms used in part 1316 of this chapter are defined at the beginning of 
each subpart of that part.
    (b) As used in parts 1309, 1310, and 1313 of this chapter, the 
following terms shall have the meaning specified:
    Act means the Controlled Substances Act, as amended (84 Stat. 1242; 
21 U.S.C. 801) and/or the Controlled Substances Import and Export Act, 
as amended (84 Stat. 1285; 21 U.S.C. 951).
    Administration means the Drug Enforcement Administration.
    Administrator means the Administrator of the Drug Enforcement 
Administration. The Administrator has been delegated authority under the 
Act by the Attorney General (28 CFR 0.100).
    At retail, with respect to the sale or purchase of a scheduled 
listed chemical product, means a sale or purchase for personal use, 
respectively.
    Broker and trader mean any individual, corporation, corporate 
division, partnership, association, or other legal entity which assists 
in arranging an international transaction in a listed chemical by--
    (1) Negotiating contracts;
    (2) Serving as an agent or intermediary; or
    (3) Fulfilling a formal obligation to complete the transaction by 
bringing together a buyer and seller, a buyer and transporter, or a 
seller and transporter, or by receiving any form of compensation for so 
doing.
    Chemical export means transferring ownership or control, or the 
sending or taking of threshold quantities of listed chemicals out of the 
United States (whether or not such sending or taking out constitutes an 
exportation within the meaning of the customs and related laws of the 
United States).
    Chemical exporter is a regulated person who, as the principal party 
in interest in the export transaction, has the power and responsibility 
for determining and controlling the sending of the listed chemical out 
of the United States.
    Chemical import means with respect to a listed chemical, any 
bringing in or introduction of such listed chemical into either the 
jurisdiction of the United States or into the customs territory of the 
United States (whether or not such bringing in or introduction 
constitutes an importation within the meaning of the tariff laws of the 
United States).
    Chemical importer is a regulated person who, as the principal party 
in interest in the import transaction, has the power and responsibility 
for determining and controlling the bringing in or introduction of the 
listed chemical into the United States.
    Chemical mixture means a combination of two or more chemical 
substances, at least one of which is not a listed chemical, except that 
such term does not include any combination of a listed chemical with 
another chemical that is present solely as an impurity or which has been 
created to evade the requirements of the Act.
    Combination ephedrine product means a drug product containing 
ephedrine or its salts, optical isomers, or salts of optical isomers, 
and therapeutically significant quantities of another active medicinal 
ingredient.
    Customs territory of the United States means the several States, the 
District of Columbia, and Puerto Rico.
    Drug product means an active ingredient in dosage form that has been 
approved or otherwise may be lawfully marketed under the Federal Food, 
Drug, and Cosmetic Act for distribution in the United States.
    Encapsulating machine means any manual, semi-automatic, or fully 
automatic equipment which may be used to fill shells or capsules with 
any powdered, granular, semi-solid, or liquid material.
    Established business relationship means the regulated person has 
imported or exported a listed chemical at least

[[Page 12]]

once within the past six months, or twice within the past twelve months 
from or to a foreign manufacturer, distributor, or end user of the 
chemical that has an established business with a fixed street address. A 
person or business that functions as a broker or intermediary is not a 
customer for purposes of this definition.
    Established record as an importer means that the regulated person 
has imported a listed chemical at least once within the past six months, 
or twice within the past twelve months from a foreign supplier.
    Hearing means any hearing held for the granting, denial, revocation, 
or suspension of a registration pursuant to sections 303, 304, and 1008 
of the Act (21 U.S.C. 823, 824 and 958).
    International transaction means a transaction involving the shipment 
of a listed chemical across an international border (other than a United 
States border) in which a broker or trader located in the United States 
participates.
    Jurisdiction of the United States means the customs territory of the 
United States, the Virgin Islands, the Canal Zone, Guam, American Samoa, 
and the Trust Territories of the Pacific Islands.
    Listed chemical means any List I chemical or List II chemical.
    List I chemical means a chemical specifically designated by the 
Administrator in Sec. 1310.02(a) of this chapter that, in addition to 
legitimate uses, is used in manufacturing a controlled substance in 
violation of the Act and is important to the manufacture of a controlled 
substance.
    List II chemical means a chemical, other than a List I chemical, 
specifically designated by the Administrator in Sec. 1310.02(b) of this 
chapter that, in addition to legitimate uses, is used in manufacturing a 
controlled substance in violation of the Act.
    Mobile retail vendor means a person or entity that makes sales at 
retail from a stand that is intended to be temporary or is capable of 
being moved from one location to another, whether the stand is located 
within or on the premises of a fixed facility (such as a kiosk at a 
shopping center or an airport) or whether the stand is located on 
unimproved real estate (such as a lot or field leased for retail 
purposes).
    Name means the official name, common or usual name, chemical name, 
or brand name of a substance.
    Person includes any individual, corporation, government or 
governmental subdivision or agency, business trust, partnership, 
association, or other legal entity.
    Readily retrievable means that certain records are kept by automatic 
data processing systems or other electronic or mechanized recordkeeping 
systems in such a manner that they can be separated out from all other 
records in a reasonable time and/or records are kept on which certain 
items are asterisked, redlined, or in some other manner visually 
identifiable apart from other items appearing on the records.
    Register and registration refer only to registration required and 
permitted by sections 303 or 1007 of the Act (21 U.S.C. 823 or 957).
    Registrant means any person who is registered pursuant to either 
section 303 or section 1008 of the Act (21 U.S.C. 823 or 958).
    Regular customer means a person with whom the regulated person has 
an established business relationship for a specified listed chemical or 
chemicals that has been reported to the Administration subject to the 
criteria established in part 1313 of this chapter.
    Regular importer means, with respect to a listed chemical, a person 
that has an established record as an importer of that listed chemical 
that is reported to the Administrator.
    Regulated person means any individual, corporation, partnership, 
association, or other legal entity who manufactures, distributes, 
imports, or exports a listed chemical, a tableting machine, or an 
encapsulating machine, or who acts as a broker or trader for an 
international transaction involving a listed chemical, tableting 
machine, or encapsulating machine.
    Regulated seller means a retail distributor (including a pharmacy or 
a mobile retail vendor), except that the term does not include an 
employee or agent of the distributor.
    Regulated transaction means:
    (1) A distribution, receipt, sale, importation, or exportation of a 
listed

[[Page 13]]

chemical, or an international transaction involving shipment of a listed 
chemical, or if the Administrator establishes a threshold amount for a 
specific listed chemical, a threshold amount as determined by the 
Administrator, which includes a cumulative threshold amount for multiple 
transactions, of a listed chemical, except that such term does not 
include:
    (i) A domestic lawful distribution in the usual course of business 
between agents or employees of a single regulated person; in this 
context, agents or employees means individuals under the direct 
management and control of the regulated person;
    (ii) A delivery of a listed chemical to or by a common or contract 
carrier for carriage in the lawful and usual course of the business of 
the common or contract carrier, or to or by a warehouseman for storage 
in the lawful and usual course of the business of the warehouseman, 
except that if the carriage or storage is in connection with the 
distribution, importation, or exportation of a listed chemical to a 
third person, this paragraph does not relieve a distributor, importer, 
or exporter from compliance with parts 1309, 1310, 1313, and 1315 of 
this chapter;
    (iii) Any category of transaction or any category of transaction for 
a specific listed chemical or chemicals specified by regulation of the 
Administrator as excluded from this definition as unnecessary for 
enforcement of the Act;
    (iv) Any transaction in a listed chemical that is contained in a 
drug other than a scheduled listed chemical product that may be marketed 
or distributed lawfully in the United States under the Federal Food, 
Drug, and Cosmetic Act, subject to paragraph (1)(v) of this definition, 
unless--
    (A) The Administrator has determined pursuant to the criteria in 
Sec. 1310.10 of this chapter that the drug or group of drugs is being 
diverted to obtain the listed chemical for use in the illicit production 
of a controlled substance; and
    (B) The quantity of the listed chemical contained in the drug 
included in the transaction or multiple transactions equals or exceeds 
the threshold established for that chemical;
    (v) Any transaction in a scheduled listed chemical product that is a 
sale at retail by a regulated seller or a distributor required to submit 
reports under Sec. 1310.03(c) of this chapter; or
    (vi) Any transaction in a chemical mixture designated in Sec. Sec. 
1310.12 and 1310.13 of this chapter that the Administrator has exempted 
from regulation.
    (2) A distribution, importation, or exportation of a tableting 
machine or encapsulating machine except that such term does not include 
a domestic lawful distribution in the usual course of business between 
agents and employees of a single regulated person; in this context, 
agents or employees means individuals under the direct management and 
control of the regulated person.
    Retail distributor means a grocery store, general merchandise store, 
drug store, or other entity or person whose activities as a distributor 
relating to drug products containing pseudoephedrine or 
phenylpropanolamine are limited almost exclusively to sales for personal 
use, both in number of sales and volume of sales, either directly to 
walk-in customers or in face-to-face transactions by direct sales. Also 
for the purposes of this paragraph, a ``grocery store'' is an entity 
within Standard Industrial Classification (SIC) code 5411, a ``general 
merchandise store'' is an entity within SIC codes 5300 through 5399 and 
5499, and a ``drug store'' is an entity within SIC code 5912.
    Scheduled listed chemical product means:
    (1) A product that contains ephedrine, pseudoephedrine, or 
phenylpropanolamine and may be marketed or distributed lawfully in the 
United States under the Federal Food, Drug, and Cosmetic Act as a 
nonprescription drug. Ephedrine, pseudoephedrine, and 
phenylpropanolamine include their salts, optical isomers, and salts of 
optical isomers.
    (2) Scheduled listed chemical product does not include any product 
that is a controlled substance under part 1308 of this chapter. In the 
absence of such scheduling by the Attorney General, a chemical specified 
in paragraph (1) of this definition may not be considered to be a 
controlled substance.

[[Page 14]]

    Tableting machine means any manual, semi-automatic, or fully 
automatic equipment which may be used for the compaction or molding of 
powdered or granular solids, or semi-solid material, to produce coherent 
solid tablets.
    Valid prescription means a prescription that is issued for a 
legitimate medical purpose by an individual practitioner licensed by law 
to administer and prescribe the drugs concerned and acting in the usual 
course of the practitioner's professional practice.

[75 FR 16304, Mar. 31, 2010, as amended at 77 FR 4233, Jan. 27, 2012]



Sec. 1300.03  Definitions relating to electronic orders for controlled 
substances and electronic prescriptions for controlled substances.

    For the purposes of this chapter, the following terms shall have the 
meanings specified:
    Application service provider means an entity that sells electronic 
prescription or pharmacy applications as a hosted service, where the 
entity controls access to the application and maintains the software and 
records on its servers.
    Audit trail means a record showing who has accessed an information 
technology application and what operations the user performed during a 
given period.
    Authentication means verifying the identity of the user as a 
prerequisite to allowing access to the information application.
    Authentication protocol means a well specified message exchange 
process that verifies possession of a token to remotely authenticate a 
person to an application.
    Biometric authentication means authentication based on measurement 
of the individual's physical features or repeatable actions where those 
features or actions are both distinctive to the individual and 
measurable.
    Biometric subsystem means the hardware and software used to capture, 
store, and compare biometric data. The biometric subsystem may be part 
of a larger application. The biometric subsystem is an automated system 
capable of:
    (1) Capturing a biometric sample from an end user.
    (2) Extracting and processing the biometric data from that sample.
    (3) Storing the extracted information in a database.
    (4) Comparing the biometric data with data contained in one or more 
reference databases.
    (5) Determining how well the stored data matches the newly captured 
data and indicating whether an identification or verification of 
identity has been achieved.
    Cache means to download and store information on a local server or 
hard drive.
    Certificate policy means a named set of rules that sets forth the 
applicability of the specific digital certificate to a particular 
community or class of application with common security requirements.
    Certificate revocation list (CRL) means a list of revoked, but 
unexpired certificates issued by a certification authority.
    Certification authority (CA) means an organization that is 
responsible for verifying the identity of applicants, authorizing and 
issuing a digital certificate, maintaining a directory of public keys, 
and maintaining a Certificate Revocation List.
    Certified information systems auditor (CISA) means an individual who 
has been certified by the Information Systems Audit and Control 
Association as qualified to audit information systems and who performs 
compliance audits as a regular ongoing business activity.
    Credential means an object or data structure that authoritatively 
binds an identity (and optionally, additional attributes) to a token 
possessed and controlled by a person.
    Credential service provider (CSP) means a trusted entity that issues 
or registers tokens and issues electronic credentials to individuals. 
The CSP may be an independent third party or may issue credentials for 
its own use.
    CSOS means controlled substance ordering system.
    Digital certificate means a data record that, at a minimum--
    (1) Identifies the certification authority issuing it;
    (2) Names or otherwise identifies the certificate holder;

[[Page 15]]

    (3) Contains a public key that corresponds to a private key under 
the sole control of the certificate holder;
    (4) Identifies the operational period; and
    (5) Contains a serial number and is digitally signed by the 
certification authority issuing it.
    Digital signature means a record created when a file is 
algorithmically transformed into a fixed length digest that is then 
encrypted using an asymmetric cryptographic private key associated with 
a digital certificate. The combination of the encryption and algorithm 
transformation ensure that the signer's identity and the integrity of 
the file can be confirmed.
    Digitally sign means to affix a digital signature to a data file.
    Electronic prescription means a prescription that is generated on an 
electronic application and transmitted as an electronic data file.
    Electronic prescription application provider means an entity that 
develops or markets electronic prescription software either as a stand-
alone application or as a module in an electronic health record 
application.
    Electronic signature means a method of signing an electronic message 
that identifies a particular person as the source of the message and 
indicates the person's approval of the information contained in the 
message.
    False match rate means the rate at which an impostor's biometric is 
falsely accepted as being that of an authorized user. It is one of the 
statistics used to measure biometric performance when operating in the 
verification or authentication task. The false match rate is similar to 
the false accept (or acceptance) rate.
    False non-match rate means the rate at which a genuine user's 
biometric is falsely rejected when the user's biometric data fail to 
match the enrolled data for the user. It is one of the statistics used 
to measure biometric performance when operating in the verification or 
authentication task. The false match rate is similar to the false reject 
(or rejection) rate, except that it does not include the rate at which a 
biometric system fails to acquire a biometric sample from a genuine 
user.
    FIPS means Federal Information Processing Standards. These Federal 
standards, as incorporated by reference in Sec. 1311.08 of this 
chapter, prescribe specific performance requirements, practices, 
formats, communications protocols, etc., for hardware, software, data, 
etc.
    FIPS 140-2, as incorporated by reference in Sec. 1311.08 of this 
chapter, means the National Institute of Standards and Technology 
publication entitled ``Security Requirements for Cryptographic 
Modules,'' a Federal standard for security requirements for 
cryptographic modules.
    FIPS 180-2, as incorporated by reference in Sec. 1311.08 of this 
chapter, means the National Institute of Standards and Technology 
publication entitled ``Secure Hash Standard,'' a Federal secure hash 
standard.
    FIPS 180-3, as incorporated by reference in Sec. 1311.08 of this 
chapter, means the National Institute of Standards and Technology 
publication entitled ``Secure Hash Standard (SHS),'' a Federal secure 
hash standard.
    FIPS 186-2, as incorporated by reference in Sec. 1311.08 of this 
chapter, means the National Institute of Standards and Technology 
publication entitled ``Digital Signature Standard,'' a Federal standard 
for applications used to generate and rely upon digital signatures.
    FIPS 186-3, as incorporated by reference in Sec. 1311.08 of this 
chapter, means the National Institute of Standards and Technology 
publication entitled ``Digital Signature Standard (DSS),'' a Federal 
standard for applications used to generate and rely upon digital 
signatures.
    Hard token means a cryptographic key stored on a special hardware 
device (e.g., a PDA, cell phone, smart card, USB drive, one-time 
password device) rather than on a general purpose computer.
    Identity proofing means the process by which a credential service 
provider or certification authority validates sufficient information to 
uniquely identify a person.
    Installed electronic prescription application means software that is 
used to create electronic prescriptions and that is installed on a 
practitioner's computers

[[Page 16]]

and servers, where access and records are controlled by the 
practitioner.
    Installed pharmacy application means software that is used to 
process prescription information and that is installed on a pharmacy's 
computers or servers and is controlled by the pharmacy.
    Intermediary means any technology system that receives and transmits 
an electronic prescription between the practitioner and pharmacy.
    Key pair means two mathematically related keys having the properties 
that:
    (1) One key can be used to encrypt a message that can only be 
decrypted using the other key; and
    (2) Even knowing one key, it is computationally infeasible to 
discover the other key.
    NIST means the National Institute of Standards and Technology.
    NIST SP 800-63-1, as incorporated by reference in Sec. 1311.08 of 
this chapter, means the National Institute of Standards and Technology 
publication entitled ``Electronic Authentication Guideline,'' a Federal 
standard for electronic authentication.
    NIST SP 800-76-1, as incorporated by reference in Sec. 1311.08 of 
this chapter, means the National Institute of Standards and Technology 
publication entitled ``Biometric Data Specification for Personal 
Identity Verification,'' a Federal standard for biometric data 
specifications for personal identity verification.
    Operating point means a point chosen on a receiver operating 
characteristic (ROC) curve for a specific algorithm at which the 
biometric system is set to function. It is defined by its corresponding 
coordinates--a false match rate and a false non-match rate. An ROC curve 
shows graphically the trade-off between the principal two types of 
errors (false match rate and false non-match rate) of a biometric system 
by plotting the performance of a specific algorithm on a specific set of 
data.
    Paper prescription means a prescription created on paper or computer 
generated to be printed or transmitted via facsimile that meets the 
requirements of part 1306 of this chapter including a manual signature.
    Password means a secret, typically a character string (letters, 
numbers, and other symbols), that a person memorizes and uses to 
authenticate his identity.
    PDA means a Personal Digital Assistant, a handheld computer used to 
manage contacts, appointments, and tasks.
    Pharmacy application provider means an entity that develops or 
markets software that manages the receipt and processing of electronic 
prescriptions.
    Private key means the key of a key pair that is used to create a 
digital signature.
    Public key means the key of a key pair that is used to verify a 
digital signature. The public key is made available to anyone who will 
receive digitally signed messages from the holder of the key pair.
    Public Key Infrastructure (PKI) means a structure under which a 
certification authority verifies the identity of applicants; issues, 
renews, and revokes digital certificates; maintains a registry of public 
keys; and maintains an up-to-date certificate revocation list.
    Readily retrievable means that certain records are kept by automatic 
data processing applications or other electronic or mechanized 
recordkeeping systems in such a manner that they can be separated out 
from all other records in a reasonable time and/or records are kept on 
which certain items are asterisked, redlined, or in some other manner 
visually identifiable apart from other items appearing on the records.
    SAS 70 Audit means a third-party audit of a technology provider that 
meets the American Institute of Certified Public Accountants (AICPA) 
Statement of Auditing Standards (SAS) 70 criteria.
    Signing function means any keystroke or other action used to 
indicate that the practitioner has authorized for transmission and 
dispensing a controlled substance prescription. The signing function may 
occur simultaneously with or after the completion of the two-factor 
authentication protocol that meets the requirements of part 1311 of this 
chapter. The signing function may have different names (e.g., approve, 
sign, transmit), but it serves

[[Page 17]]

as the practitioner's final authorization that he intends to issue the 
prescription for a legitimate medical reason in the normal course of his 
professional practice.
    SysTrust means a professional service performed by a qualified 
certified public accountant to evaluate one or more aspects of 
electronic systems.
    Third-party audit means an independent review and examination of 
records and activities to assess the adequacy of system controls, to 
ensure compliance with established policies and operational procedures, 
and to recommend necessary changes in controls, policies, or procedures.
    Token means something a person possesses and controls (typically a 
key or password) used to authenticate the person's identity.
    Trusted agent means an entity authorized to act as a representative 
of a certification authority or credential service provider in 
confirming practitioner identification during the enrollment process.
    Valid prescription means a prescription that is issued for a 
legitimate medical purpose by an individual practitioner licensed by law 
to administer and prescribe the drugs concerned and acting in the usual 
course of the practitioner's professional practice.
    WebTrust means a professional service performed by a qualified 
certified public accountant to evaluate one or more aspects of Web 
sites.

[75 FR 16304, Mar. 31, 2010]



Sec. 1300.04  Definitions relating to the dispensing of controlled
substances by means of the Internet.

    (a) Any term not defined in this part or elsewhere in this chapter 
shall have the definition set forth in sections 102 and 309 of the Act 
(21 U.S.C. 802, 829).
    (b) The term covering practitioner means, with respect to a patient, 
a practitioner who conducts a medical evaluation (other than an in-
person medical evaluation) at the request of a practitioner who:
    (1) Has conducted at least one in-person medical evaluation of the 
patient or an evaluation of the patient through the practice of 
telemedicine, within the previous 24 months; and
    (2) Is temporarily unavailable to conduct the evaluation of the 
patient.
    (c) The term deliver, distribute, or dispense by means of the 
Internet refers, respectively, to any delivery, distribution, or 
dispensing of a controlled substance that is caused or facilitated by 
means of the Internet.
    (d) The term filling new prescriptions for controlled substances in 
Schedule III, IV, or V means filling a prescription for an individual 
for a controlled substance in Schedule III, IV, or V, if:
    (1) The pharmacy dispensing that prescription has previously 
dispensed to the patient a controlled substance other than by means of 
the Internet and pursuant to the valid prescription of a practitioner 
that meets the applicable requirements of subsections (b) and (c) of 
section 309 of the Act (21 U.S.C. 829) and Sec. Sec. 1306.21 and 
1306.22 of this chapter (for purposes of this definition, such a 
prescription shall be referred to as the ``original prescription'');
    (2) The pharmacy contacts the practitioner who issued the original 
prescription at the request of that individual to determine whether the 
practitioner will authorize the issuance of a new prescription for that 
individual for the controlled substance described in paragraph (d)(1) of 
this section (i.e., the same controlled substance as described in 
paragraph (d)(1)); and
    (3) The practitioner, acting in the usual course of professional 
practice, determines there is a legitimate medical purpose for the 
issuance of the new prescription.
    (e) The term homepage means the opening or main page or screen of 
the Web site of an online pharmacy that is viewable on the Internet.
    (f) The term in-person medical evaluation means a medical evaluation 
that is conducted with the patient in the physical presence of the 
practitioner, without regard to whether portions of the evaluation are 
conducted by other health professionals. Nothing in this paragraph shall 
be construed to imply that one in-person medical evaluation demonstrates 
that a prescription has been issued for a legitimate medical purpose 
within the usual course of professional practice.

[[Page 18]]

    (g) The term Internet means collectively the myriad of computer and 
telecommunications facilities, including equipment and operating 
software, which comprise the interconnected worldwide network of 
networks that employ the Transmission Control Protocol/Internet 
Protocol, or any predecessor or successor protocol to such protocol, to 
communicate information of all kinds by wire or radio.
    (h) The term online pharmacy means a person, entity, or Internet 
site, whether in the United States or abroad, that knowingly or 
intentionally delivers, distributes, or dispenses, or offers or attempts 
to deliver, distribute, or dispense, a controlled substance by means of 
the Internet. The term includes, but is not limited to, a pharmacy that 
has obtained a modification of its registration pursuant to Sec. Sec. 
1301.13 and 1301.19 of this chapter that currently authorizes it to 
dispense controlled substances by means of the Internet, regardless of 
whether the pharmacy is currently dispensing controlled substances by 
means of the Internet. The term does not include:
    (1) Manufacturers or distributors registered under subsection (a), 
(b), (d), or (e) of section 303 of the Act (21 U.S.C. 823(a), (b), (d), 
or (e)) (Sec. 1301.13 of this chapter) who do not dispense controlled 
substances to an unregistered individual or entity;
    (2) Nonpharmacy practitioners who are registered under section 
303(f) of the Act (21 U.S.C. 823(f)) (Sec. 1301.13 of this chapter) and 
whose activities are authorized by that registration;
    (3) Any hospital or other medical facility that is operated by an 
agency of the United States (including the Armed Forces), provided such 
hospital or other facility is registered under section 303(f) of the Act 
(21 U.S.C. 823(f)) (Sec. 1301.13 of this chapter);
    (4) A health care facility owned or operated by an Indian tribe or 
tribal organization, only to the extent such facility is carrying out a 
contract or compact under the Indian Self-Determination and Education 
Assistance Act;
    (5) Any agent or employee of any hospital or facility referred to in 
paragraph (h)(3) or (h)(4) of this section, provided such agent or 
employee is lawfully acting in the usual course of business or 
employment, and within the scope of the official duties of such agent or 
employee, with such hospital or facility, and, with respect to agents or 
employees of health care facilities specified in paragraph (h)(4) of 
this section, only to the extent such individuals are furnishing 
services pursuant to the contracts or compacts described in such 
paragraph;
    (6) Mere advertisements that do not attempt to facilitate an actual 
transaction involving a controlled substance;
    (7) A person, entity, or Internet site that is not in the United 
States and does not facilitate the delivery, distribution, or dispensing 
of a controlled substance by means of the Internet to any person in the 
United States;
    (8) A pharmacy registered under section 303(f) of the Act (21 U.S.C. 
823(f)) (Sec. 1301.13 of this chapter) whose dispensing of controlled 
substances via the Internet consists solely of:
    (i) Refilling prescriptions for controlled substances in Schedule 
III, IV, or V, as defined in paragraph (k) of this section; or
    (ii) Filling new prescriptions for controlled substances in Schedule 
III, IV, or V, as defined in paragraph (d) of this section;
    (9)(i) Any registered pharmacy whose delivery, distribution, or 
dispensing of controlled substances by means of the Internet consists 
solely of filling prescriptions that were electronically prescribed in a 
manner authorized by this chapter and otherwise in compliance with the 
Act.
    (ii) A registered pharmacy will be deemed to meet this exception if, 
in view of all of its activities other than those referred to in 
paragraph (h)(9)(i) of this section, it would fall outside the 
definition of an online pharmacy; or
    (10)(i) Any registered pharmacy whose delivery, distribution, or 
dispensing of controlled substances by means of the Internet consists 
solely of the transmission of prescription information between a 
pharmacy and an automated dispensing system located in a long term care 
facility when the registration of the automated dispensing system is 
held by that pharmacy as described in Sec. Sec. 1301.17 and

[[Page 19]]

1301.27 and the pharmacy is otherwise complying with this chapter.
    (ii) A registered pharmacy will be deemed to meet this exception if, 
in view of all of its activities other than those referred to in 
paragraph (h)(10)(i) of this section, it would fall outside the 
definition of an online pharmacy.
    (i) Effective January 15, 2010, the term practice of telemedicine 
means the practice of medicine in accordance with applicable Federal and 
State laws by a practitioner (other than a pharmacist) who is at a 
location remote from the patient and is communicating with the patient, 
or health care professional who is treating the patient, using a 
telecommunications system referred to in section 1834(m) of the Social 
Security Act (42 U.S.C. 1395m(m)), which practice falls within a 
category listed in the following paragraphs (i)(1) through (7):
    (1) Treatment in a hospital or clinic. The practice of telemedicine 
is being conducted while the patient is being treated by, and physically 
located in, a hospital or clinic registered under section 303(f) of the 
Act (21 U.S.C. 823(f)) by a practitioner acting in the usual course of 
professional practice, who is acting in accordance with applicable State 
law, and who is registered under section 303(f) of the Act (21 U.S.C. 
823(f)) in the State in which the patient is located, unless the 
practitioner:
    (i) Is exempted from such registration in all States under section 
302(d) of the Act (21 U.S.C. 822(d); or
    (ii) Is an employee or contractor of the Department of Veterans 
Affairs who is acting in the scope of such employment or contract, and 
registered under section 303(f) of the Act (21 U.S.C. 823(f)) in any 
State or is utilizing the registration of a hospital or clinic operated 
by the Department of Veterans Affairs registered under section 303(f);
    (2) Treatment in the physical presence of a practitioner. The 
practice of telemedicine is being conducted while the patient is being 
treated by, and in the physical presence of, a practitioner acting in 
the usual course of professional practice, who is acting in accordance 
with applicable State law, and who is registered under section 303(f) of 
the Act (21 U.S.C. 823(f)) in the State in which the patient is located, 
unless the practitioner:
    (i) Is exempted from such registration in all States under section 
302(d) of the Act (21 U.S.C. 822(d)); or
    (ii) Is an employee or contractor of the Department of Veterans 
Affairs who is acting in the scope of such employment or contract, and 
registered under section 303(f) of the Act (21 U.S.C. 823(f)) in any 
State or is using the registration of a hospital or clinic operated by 
the Department of Veterans Affairs registered under section 303(f);
    (3) Indian Health Service or tribal organization. The practice of 
telemedicine is being conducted by a practitioner who is an employee or 
contractor of the Indian Health Service, or is working for an Indian 
tribe or tribal organization under its contract or compact with the 
Indian Health Service under the Indian Self-Determination and Education 
Assistance Act; who is acting within the scope of the employment, 
contract, or compact; and who is designated as an Internet Eligible 
Controlled Substances Provider by the Secretary of Health and Human 
Services under section 311(g)(2) of the Act (21 U.S.C. 831(g)(2));
    (4) Public health emergency declared by the Secretary of Health and 
Human Services. The practice of telemedicine is being conducted during a 
public health emergency declared by the Secretary of Health and Human 
Services under section 319 of the Public Health Service Act (42 U.S.C. 
247d), and involves patients located in such areas, and such controlled 
substances, as the Secretary of Health and Human Services, with the 
concurrence of the Administrator, designates, provided that such 
designation shall not be subject to the procedures prescribed by the 
Administrative Procedure Act (5 U.S.C. 551-559 and 701-706);
    (5) Special registration. The practice of telemedicine is being 
conducted by a practitioner who has obtained from the Administrator a 
special registration under section 311(h) of the Act (21 U.S.C. 831(h));
    (6) Department of Veterans Affairs medical emergency. The practice 
of telemedicine is being conducted:
    (i) In a medical emergency situation:

[[Page 20]]

    (A) That prevents the patient from being in the physical presence of 
a practitioner registered under section 303(f) of the Act (21 U.S.C. 
823(f)) who is an employee or contractor of the Veterans Health 
Administration acting in the usual course of business and employment and 
within the scope of the official duties or contract of that employee or 
contractor;
    (B) That prevents the patient from being physically present at a 
hospital or clinic operated by the Department of Veterans Affairs 
registered under section 303(f) of the Act (21 U.S.C. 823(f));
    (C) During which the primary care practitioner of the patient or a 
practitioner otherwise practicing telemedicine within the meaning of 
this paragraph is unable to provide care or consultation; and
    (D) That requires immediate intervention by a health care 
practitioner using controlled substances to prevent what the 
practitioner reasonably believes in good faith will be imminent and 
serious clinical consequences, such as further injury or death; and
    (ii) By a practitioner that:
    (A) Is an employee or contractor of the Veterans Health 
Administration acting within the scope of that employment or contract;
    (B) Is registered under section 303(f) of the Act (21 U.S.C. 823(f)) 
in any State or is utilizing the registration of a hospital or clinic 
operated by the Department of Veterans Affairs registered under section 
303(f); and
    (C) Issues a controlled substance prescription in this emergency 
context that is limited to a maximum of a five-day supply which may not 
be extended or refilled; or
    (7) Other circumstances specified by regulation. The practice of 
telemedicine is being conducted under any other circumstances that the 
Administrator and the Secretary of Health and Human Services have 
jointly, by regulation, determined to be consistent with effective 
controls against diversion and otherwise consistent with the public 
health and safety.
    (j) Temporary definition of practice of telemedicine. Prior to 
January 15, 2010, or as otherwise specified by regulation prior to that 
date, instead of the definition in paragraph (i), the term practice of 
telemedicine means the practice of medicine in accordance with 
applicable Federal and State laws by a practitioner (as that term is 
defined in section 102 of the Act (21 U.S.C. 802)) (other than a 
pharmacist) who is at a location remote from the patient and is 
communicating with the patient, or health care professional who is 
treating the patient, using a telecommunications system referred to in 
section 1834(m) of the Social Security Act (42 U.S.C. 1395m(m)), if the 
practitioner is using an interactive telecommunications system that 
satisfies the requirements of section 410.78(a)(3) of title 42, Code of 
Federal Regulations.
    (k) The term refilling prescriptions for controlled substances in 
Schedule III, IV, or V:
    (1) Means the dispensing of a controlled substance in Schedule III, 
IV, or V in accordance with refill instructions issued by a practitioner 
as part of a valid prescription that meets the requirements of 
subsections (b) and (c) of section 309 of the Act (21 U.S.C. 829) and 
Sec. Sec. 1306.21 and 1306.22 of this chapter, as appropriate; and
    (2) Does not include the issuance of a new prescription to an 
individual for a controlled substance that individual was previously 
prescribed.
    (l)(1) The term valid prescription means a prescription that is 
issued for a legitimate medical purpose in the usual course of 
professional practice by:
    (i) A practitioner who has conducted at least one in-person medical 
evaluation of the patient; or
    (ii) A covering practitioner.
    (2) Nothing in this paragraph (l) shall be construed to imply that 
one in-person medical evaluation demonstrates that a prescription has 
been issued for a legitimate medical purpose within the usual course of 
professional practice.

[74 FR 15619, Apr. 6, 2009]

[[Page 21]]



PART 1301_REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, AND DISPENSERS
OF CONTROLLED SUBSTANCES--Table of Contents



                           General Information

Sec.
1301.01 Scope of this part 1301.
1301.02 Definitions.
1301.03 Information; special instructions.

                              Registration

1301.11 Persons required to register; requirement of modification of 
          registration authorizing activity as an online pharmacy.
1301.12 Separate registrations for separate locations.
1301.13 Application for registration; time for application; expiration 
          date; registration for independent activities; application 
          forms, fees, contents and signature; coincident activities.
1301.14 Filing of application; acceptance for filing; defective 
          applications.
1301.15 Additional information.
1301.16 Amendments to and withdrawal of applications.
1301.17 Special procedures for certain applications.
1301.18 Research protocols.
1301.19 Special requirements for online pharmacies.

                   Exceptions to Registration and Fees

1301.21 Exception from fees.
1301.22 Exemption of agents and employees; affiliated practitioners.
1301.23 Exemption of certain military and other personnel.
1301.24 Exemption of law enforcement officials.
1301.25 Registration regarding ocean vessels, aircraft, and other 
          entities.
1301.26 Exemptions from import or export requirements for personal 
          medical use.
1301.27 Separate registration by retail pharmacies for installation and 
          operation of automated dispensing systems at long term care 
          facilities.
1301.28 Exemption from separate registration for practitioners 
          dispensing or prescribing Schedule III, IV, or V narcotic 
          controlled drugs approved by the Food and Drug Administration 
          specifically for use in maintenance or detoxification 
          treatment.

  Action on Application for Registration: Revocation or Suspension of 
                              Registration

1301.31 Administrative review generally.
1301.32 Action on applications for research in Schedule I substances.
1301.33 Application for bulk manufacture of Schedule I and II 
          substances.
1301.34 Application for importation of Schedule I and II substances.
1301.35 Certificate of registration; denial of registration.
1301.36 Suspension or revocation of registration; suspension of 
          registration pending final order; extension of registration 
          pending final order.
1301.37 Order to show cause.

                                Hearings

1301.41 Hearings generally.
1301.42 Purpose of hearing.
1301.43 Request for hearing or appearance; waiver.
1301.44 Burden of proof.
1301.45 Time and place of hearing.
1301.46 Final order.

         Modification, Transfer, and Termination of Registration

1301.51 Modification in registration.
1301.52 Termination of registration; transfer of registration; 
          distribution upon discontinuance of business.

                          Security Requirements

1301.71 Security requirements generally.
1301.72 Physical security controls for nonpractitioners; narcotic 
          treatment programs and compounders for narcotic treatment 
          programs; storage areas.
1301.73 Physical security controls for nonpractitioners; compounders for 
          narcotic treatment programs; manufacturing and compounding 
          areas.
1301.74 Other security controls for nonpractitioners; narcotic treatment 
          programs and compounders for narcotic treatment programs.
1301.75 Physical security controls for practitioners.
1301.76 Other security controls for practitioners.
1301.77 Security controls for freight forwarding facilities.

                  Employee Screening--Non-Practitioners

1301.90 Employee screening procedures.
1301.91 Employee responsibility to report drug diversion.
1301.92 Illicit activities by employees.
1301.93 Sources of information for employee checks.

    Authority: 21 U.S.C. 821, 822, 823, 824, 831, 871(b), 875, 877, 
886a, 951, 952, 953, 956, 957, 958.

    Source: 36 FR 7778, Apr. 24, 1971, unless otherwise noted. 
Redesignated at 38 FR 26609, Sept. 24, 1973.

[[Page 22]]

                           General Information



Sec. 1301.01  Scope of this part 1301.

    Procedures governing the registration of manufacturers, 
distributors, dispensers, importers, and exporters of controlled 
substances pursuant to sections 301-304 and 1007-1008 of the Act (21 
U.S.C. 821-824 and 957-958) are set forth generally by those sections 
and specifically by the sections of this part.

[62 FR 13945, Mar. 24, 1997]



Sec. 1301.02  Definitions.

    Any term used in this part shall have the definition set forth in 
section 102 of the Act (21 U.S.C. 802) or part 1300 of this chapter.

[62 FR 13945, Mar. 24, 1997]



Sec. 1301.03  Information; special instructions.

    Information regarding procedures under these rules and instructions 
supplementing these rules will be furnished upon request by writing to 
the Registration Section, Drug Enforcement Administration. See the Table 
of DEA Mailing Addresses in Sec. 1321.01 of this chapter for the 
current mailing address.

[75 FR 10676, Mar. 9, 2010]

                              Registration



Sec. 1301.11  Persons required to register; requirement of modification
of registration authorizing activity as an online pharmacy.

    (a) Every person who manufactures, distributes, dispenses, imports, 
or exports any controlled substance or who proposes to engage in the 
manufacture, distribution, dispensing, importation or exportation of any 
controlled substance shall obtain a registration unless exempted by law 
or pursuant to Sec. Sec. 1301.22 through 1301.26. Except as provided in 
paragraph (b) of this section, only persons actually engaged in such 
activities are required to obtain a registration; related or affiliated 
persons who are not engaged in such activities are not required to be 
registered. (For example, a stockholder or parent corporation of a 
corporation manufacturing controlled substances is not required to 
obtain a registration.)
    (b) As provided in sections 303(f) and 401(h) of the Act (21 U.S.C. 
823(f) and 841(h)), it is unlawful for any person who falls within the 
definition of ``online pharmacy'' (as set forth in section 102(52) of 
the Act (21 U.S.C. 802(52)) and Sec. 1300.04(h) of this chapter) to 
deliver, distribute, or dispense a controlled substance by means of the 
Internet if such person is not validly registered with a modification of 
such registration authorizing such activity (unless such person is 
exempt from such modified registration requirement under the Act or this 
chapter). The Act further provides that the Administrator may only issue 
such modification of registration to a person who is registered as a 
pharmacy under section 303(f) of the Act (21 U.S.C. 823(f)). 
Accordingly, any pharmacy registered pursuant to Sec. 1301.13 of this 
part that falls within the definition of an online pharmacy and proposes 
to dispense controlled substances by means of the Internet must obtain a 
modification of its registration authorizing such activity following the 
submission of an application in accordance with Sec. 1301.19 of this 
part. This requirement does not apply to a registered pharmacy that does 
not fall within the definition of an online pharmacy set forth in Sec. 
1300.04(h). Under the Act, persons other than registered pharmacies are 
not eligible to obtain such a modification of registration but remain 
liable under section 401(h) of the Act (21 U.S.C. 841(h)) if they 
deliver, distribute, or dispense a controlled substance while acting as 
an online pharmacy without being validly registered with a modification 
authorizing such activity.

[74 FR 15621, Apr. 6, 2009]



Sec. 1301.12  Separate registrations for separate locations.

    (a) A separate registration is required for each principal place of 
business or professional practice at one general physical location where 
controlled substances are manufactured, distributed, imported, exported, 
or dispensed by a person.
    (b) The following locations shall be deemed not to be places where 
controlled substances are manufactured, distributed, or dispensed:

[[Page 23]]

    (1) A warehouse where controlled substances are stored by or on 
behalf of a registered person, unless such substances are distributed 
directly from such warehouse to registered locations other than the 
registered location from which the substances were delivered or to 
persons not required to register by virtue of subsection 302(c)(2) or 
subsection 1007(b)(1)(B) of the Act (21 U.S.C. 822(c)(2) or 
957(b)(1)(B));
    (2) An office used by agents of a registrant where sales of 
controlled substances are solicited, made, or supervised but which 
neither contains such substances (other than substances for display 
purposes or lawful distribution as samples only) nor serves as a 
distribution point for filling sales orders; and
    (3) An office used by a practitioner (who is registered at another 
location in the same State or jurisdiction of the United States) where 
controlled substances are prescribed but neither administered nor 
otherwise dispensed as a regular part of the professional practice of 
the practitioner at such office, and where no supplies of controlled 
substances are maintained.
    (4) A freight forwarding facility, as defined in Sec. 1300.01 of 
this part, provided that the distributing registrant operating the 
facility has submitted written notice of intent to operate the facility 
by registered mail, return receipt requested (or other suitable means of 
documented delivery) and such notice has been approved. The notice shall 
be submitted to the Special Agent in Charge of the Administration's 
offices in both the area in which the facility is located and each area 
in which the distributing registrant maintains a registered location 
that will transfer controlled substances through the facility. The 
notice shall detail the registered locations that will utilize the 
facility, the location of the facility, the hours of operation, the 
individual(s) responsible for the controlled substances, the security 
and recordkeeping procedures that will be employed, and whether 
controlled substances returns will be processed through the facility. 
The notice must also detail what state licensing requirements apply to 
the facility and the registrant's actions to comply with any such 
requirements. The Special Agent in Charge of the DEA Office in the area 
where the freight forwarding facility will be operated will provide 
written notice of approval or disapproval to the person within thirty 
days after confirmed receipt of the notice. Registrants that are 
currently operating freight forwarding facilities under a memorandum of 
understanding with the Administration must provide notice as required by 
this section no later than September 18, 2000 and receive written 
approval from the Special Agent in Charge of the DEA Office in the area 
in which the freight forwarding facility is operated in order to 
continue operation of the facility.

[62 FR 13945, Mar. 24, 1997, as amended at 65 FR 44678, July 19, 2000; 
65 FR 45829, July 25, 2000; 71 FR 69480, Dec. 1, 2006]



Sec. 1301.13  Application for registration; time for application; 
expiration date; registration for independent activities; application 

forms, fees, contents and signature; coincident activities.

    (a) Any person who is required to be registered and who is not so 
registered may apply for registration at any time. No person required to 
be registered shall engage in any activity for which registration is 
required until the application for registration is granted and a 
Certificate of Registration is issued by the Administrator to such 
person.
    (b) Any person who is registered may apply to be reregistered not 
more than 60 days before the expiration date of his/her registration, 
except that a bulk manufacturer of Schedule I or II controlled 
substances or an importer of Schedule I or II controlled substances may 
apply to be reregistered no more than 120 days before the expiration 
date of their registration.
    (c) At the time a manufacturer, distributor, reverse distributor, 
researcher, analytical lab, importer, exporter or narcotic treatment 
program is first registered, that business activity shall be assigned to 
one of twelve groups, which shall correspond to the months of the year. 
The expiration date of the registrations of all registrants within any 
group will be the last date of the month designated for that group. In 
assigning any of these

[[Page 24]]

business activities to a group, the Administration may select a group 
the expiration date of which is less than one year from the date such 
business activity was registered. If the business activity is assigned 
to a group which has an expiration date less than three months from the 
date of which the business activity is registered, the registration 
shall not expire until one year from that expiration date; in all other 
cases, the registration shall expire on the expiration date following 
the date on which the business activity is registered.
    (d) At the time a retail pharmacy, hospital/clinic, practitioner or 
teaching institution is first registered, that business activity shall 
be assigned to one of twelve groups, which shall correspond to the 
months of the year. The expiration date of the registrations of all 
registrants within any group will be the last day of the month 
designated for that group. In assigning any of the above business 
activities to a group, the Administration may select a group the 
expiration date of which is not less than 28 months nor more than 39 
months from the date such business activity was registered. After the 
initial registration period, the registration shall expire 36 months 
from the initial expiration date.
    (e) Any person who is required to be registered and who is not so 
registered, shall make application for registration for one of the 
following groups of controlled substances activities, which are deemed 
to be independent of each other. Application for each registration shall 
be made on the indicated form, and shall be accompanied by the indicated 
fee. Fee payments shall be made in the form of a personal, certified, or 
cashier's check or money order made payable to the ``Drug Enforcement 
Administration''. The application fees are not refundable. Any person, 
when registered to engage in the activities described in each 
subparagraph in this paragraph, shall be authorized to engage in the 
coincident activities described without obtaining a registration to 
engage in such coincident activities, provided that, unless specifically 
exempted, he/she complies with all requirements and duties prescribed by 
law for persons registered to engage in such coincident activities. Any 
person who engages in more than one group of independent activities 
shall obtain a separate registration for each group of activities, 
except as provided in this paragraph under coincident activities. A 
single registration to engage in any group of independent activities 
listed below may include one or more controlled substances listed in the 
schedules authorized in that group of independent activities. A person 
registered to conduct research with controlled substances listed in 
Schedule I may conduct research with any substances listed in Schedule I 
for which he/she has filed and had approved a research protocol.
    (1)

----------------------------------------------------------------------------------------------------------------
                                                                                 Registration      Coincident
       Business activity           Controlled      DEA Application  Application     period         activities
                                   substances           forms         fee ($)       (years)         allowed
----------------------------------------------------------------------------------------------------------------
(i) Manufacturing.............  Schedules I-V...  New-225 Renewal-       $3,047             1  Schedules I-V:
                                                   225a.                                        May distribute
                                                                                                that substance
                                                                                                or class for
                                                                                                which
                                                                                                registration was
                                                                                                issued; may not
                                                                                                distribute or
                                                                                                dispose of any
                                                                                                substance or
                                                                                                class for which
                                                                                                not registered.
                                                                                                Schedules II-V:
                                                                                                Except a person
                                                                                                registered to
                                                                                                dispose of any
                                                                                                controlled
                                                                                                substance may
                                                                                                conduct chemical
                                                                                                analysis and
                                                                                                preclinical
                                                                                                research
                                                                                                (including
                                                                                                quality control
                                                                                                analysis) with
                                                                                                substances
                                                                                                listed in those
                                                                                                schedules for
                                                                                                which
                                                                                                authorization as
                                                                                                a mfg. was
                                                                                                issued.
(ii) Distributing.............  Schedules I-V...  New-225 Renewal-        1,523             1
                                                   225a.
(iii) Reverse distributing....  Schedules I-V...  New-225 Renewal-        1,523             1
                                                   225a.

[[Page 25]]

 
(iv) Dispensing or instructing  Schedules II-V..  New-224 Renewal-          731             3  May conduct
 (includes Practitioner,                           224a.                                        research and
 Hospital/Clinic, Retail                                                                        instructional
 Pharmacy, Central fill                                                                         activities with
 pharmacy, Teaching                                                                             those substances
 Institution).                                                                                  for which
                                                                                                registration was
                                                                                                granted, except
                                                                                                that a mid-level
                                                                                                practitioner may
                                                                                                conduct such
                                                                                                research only to
                                                                                                the extent
                                                                                                expressly
                                                                                                authorized under
                                                                                                state statute. A
                                                                                                pharmacist may
                                                                                                manufacture an
                                                                                                aqueous or
                                                                                                oleaginous
                                                                                                solution or
                                                                                                solid dosage
                                                                                                form containing
                                                                                                a narcotic
                                                                                                controlled
                                                                                                substance in
                                                                                                Schedule II-V in
                                                                                                a proportion not
                                                                                                exceeding 20% of
                                                                                                the complete
                                                                                                solution,
                                                                                                compound or
                                                                                                mixture. A
                                                                                                retail pharmacy
                                                                                                may perform
                                                                                                central fill
                                                                                                pharmacy
                                                                                                activities.
(v) Research..................  Schedule I......  New-225 Renewal-          244             1  A researcher may
                                                   225a.                                        manufacture or
                                                                                                import the basic
                                                                                                class of
                                                                                                substance or
                                                                                                substances for
                                                                                                which
                                                                                                registration was
                                                                                                issued, provided
                                                                                                that such
                                                                                                manufacture or
                                                                                                import is set
                                                                                                forth in the
                                                                                                protocol
                                                                                                required in Sec.
                                                                                                  1301.18 and to
                                                                                                distribute such
                                                                                                class to persons
                                                                                                registered or
                                                                                                authorized to
                                                                                                conduct research
                                                                                                with such class
                                                                                                of substance or
                                                                                                registered or
                                                                                                authorized to
                                                                                                conduct chemical
                                                                                                analysis with
                                                                                                controlled
                                                                                                substances.
(vi) Research.................  Schedules II-V..  New-225 Renewal-          244             1  May conduct
                                                   225a.                                        chemical
                                                                                                analysis with
                                                                                                controlled
                                                                                                substances in
                                                                                                those schedules
                                                                                                for which
                                                                                                registration was
                                                                                                issued;
                                                                                                manufacture such
                                                                                                substances if
                                                                                                and to the
                                                                                                extent that such
                                                                                                manufacture is
                                                                                                set forth in a
                                                                                                statement filed
                                                                                                with the
                                                                                                application for
                                                                                                registration or
                                                                                                reregistration
                                                                                                and provided
                                                                                                that the
                                                                                                manufacture is
                                                                                                not for the
                                                                                                purposes of
                                                                                                dosage form
                                                                                                development;
                                                                                                import such
                                                                                                substances for
                                                                                                research
                                                                                                purposes;
                                                                                                distribute such
                                                                                                substances to
                                                                                                persons
                                                                                                registered or
                                                                                                authorized to
                                                                                                conduct chemical
                                                                                                analysis,
                                                                                                instructional
                                                                                                activities or
                                                                                                research with
                                                                                                such substances,
                                                                                                and to persons
                                                                                                exempted from
                                                                                                registration
                                                                                                pursuant to Sec.
                                                                                                  1301.24; and
                                                                                                conduct
                                                                                                instructional
                                                                                                activities with
                                                                                                controlled
                                                                                                substances.
(vii) Narcotic Treatment        Narcotic Drugs    New-363 Renewal-          244             1
 Program (including              in Schedules II-  363a.
 compounder).                    V.
(viii) Importing..............  Schedules I-V...  New-225 Renewal-        1,523             1  May distribute
                                                   225a.                                        that substance
                                                                                                or class for
                                                                                                which
                                                                                                registration was
                                                                                                issued; may not
                                                                                                distribute any
                                                                                                substance or
                                                                                                class for which
                                                                                                not registered.
(ix) Exporting................  Schedules I-V...  New-225 Renewal-        1,523             1
                                                   225a.

[[Page 26]]

 
(x) Chemical Analysis.........  Schedules I-V...  New-225 Renewal-          244             1  May manufacture
                                                   225a.                                        and import
                                                                                                controlled
                                                                                                substances for
                                                                                                analytical or
                                                                                                instructional
                                                                                                activities; may
                                                                                                distribute such
                                                                                                substances to
                                                                                                persons
                                                                                                registered or
                                                                                                authorized to
                                                                                                conduct chemical
                                                                                                analysis,
                                                                                                instructional
                                                                                                activities, or
                                                                                                research with
                                                                                                such substances
                                                                                                and to persons
                                                                                                exempted from
                                                                                                registration
                                                                                                pursuant to Sec.
                                                                                                  1301.24; may
                                                                                                export such
                                                                                                substances to
                                                                                                persons in other
                                                                                                countries
                                                                                                performing
                                                                                                chemical
                                                                                                analysis or
                                                                                                enforcing laws
                                                                                                related to
                                                                                                controlled
                                                                                                substances or
                                                                                                drugs in those
                                                                                                countries; and
                                                                                                may conduct
                                                                                                instructional
                                                                                                activities with
                                                                                                controlled
                                                                                                substances.
----------------------------------------------------------------------------------------------------------------

    (2) DEA Forms 224, 225, and 363 may be obtained at any area office 
of the Administration or by writing to the Registration Section, Drug 
Enforcement Administration. See the Table of DEA Mailing Addresses in 
Sec. 1321.01 of this chapter for the current mailing address.
    (3) Registrants will receive renewal notifications approximately 60 
days prior to the registration expiration date. DEA Forms 224a, 225a, 
and 363a may be mailed, as applicable, to registrants; if any registered 
person does not receive such notification within 45 days before the 
registration expiration date, the registrant must promptly give notice 
of such fact and may request such forms by writing to the Registration 
Section, Drug Enforcement Administration.
    (f) Each application for registration to handle any basic class of 
controlled substance listed in Schedule I (except to conduct chemical 
analysis with such classes), and each application for registration to 
manufacture a basic class of controlled substance listed in Schedule II 
shall include the Administration Controlled Substances Code Number, as 
set forth in part 1308 of this chapter, for each basic class to be 
covered by such registration.
    (g) Each application for registration to import or export controlled 
substances shall include the Administration Controlled Substances Code 
Number, as set forth in part 1308 of this chapter, for each controlled 
substance whose importation or exportation is to be authorized by such 
registration. Registration as an importer or exporter shall not entitle 
a registrant to import or export any controlled substance not specified 
in such registration.
    (h) Each application for registration to conduct research with any 
basic class of controlled substance listed in Schedule II shall include 
the Administration Controlled Substances Code Number, as set forth in 
part 1308 of this chapter, for each such basic class to be manufactured 
or imported as a coincident activity of that registration. A statement 
listing the quantity of each such basic class of controlled substance to 
be imported or manufactured during the registration period for which 
application is being made shall be included with each such application. 
For purposes of this paragraph only, manufacturing is defined as the 
production of a controlled substance by synthesis, extraction or by 
agricultural/horticultural means.
    (i) Each application shall include all information called for in the 
form, unless the item is not applicable, in which case this fact shall 
be indicated.
    (j) Each application, attachment, or other document filed as part of 
an application, shall be signed by the applicant, if an individual; by a 
partner of the applicant, if a partnership; or by an officer of the 
applicant, if a corporation, corporate division, association, trust or 
other entity. An applicant may authorize one or more individuals, who 
would not otherwise be authorized to do so, to sign applications for the 
applicant by filing with the Registration

[[Page 27]]

Unit of the Administration a power of attorney for each such individual. 
The power of attorney shall be signed by a person who is authorized to 
sign applications under this paragraph and shall contain the signature 
of the individual being authorized to sign applications. The power of 
attorney shall be valid until revoked by the applicant.

[62 FR 13946, Mar. 24, 1997, as amended at 68 FR 37409, June 24, 2003; 
68 FR 41228, July 11, 2003; 68 FR 58598, Oct. 10, 2003; 71 FR 51112, 
Aug. 29, 2006; 74 FR 15622, Apr. 6, 2009; 75 FR 10676, Mar. 9, 2010; 77 
FR 15248, Mar. 15, 2012]



Sec. 1301.14  Filing of application; acceptance for filing; defective
applications.

    (a) All applications for registration shall be submitted for filing 
to the Registration Unit, Drug Enforcement Administration. The 
appropriate registration fee and any required attachments must accompany 
the application. See the Table of DEA Mailing Addresses in Sec. 1321.01 
of this chapter for the current mailing address.
    (b) Any person required to obtain more than one registration may 
submit all applications in one package. Each application must be 
complete and should not refer to any accompanying application for 
required information.
    (c) Applications submitted for filing are dated upon receipt. If 
found to be complete, the application will be accepted for filing. 
Applications failing to comply with the requirements of this part will 
not generally be accepted for filing. In the case of minor defects as to 
completeness, the Administrator may accept the application for filing 
with a request to the applicant for additional information. A defective 
application will be returned to the applicant within 10 days following 
its receipt with a statement of the reason for not accepting the 
application for filing. A defective application may be corrected and 
resubmitted for filing at any time; the Administrator shall accept for 
filing any application upon resubmission by the applicant, whether 
complete or not.
    (d) Accepting an application for filing does not preclude any 
subsequent request for additional information pursuant to Sec. 1301.15 
and has no bearing on whether the application will be granted.

[62 FR 13948, Mar. 24, 1997, as amended at 75 FR 10676, Mar. 9, 2010]



Sec. 1301.15  Additional information.

    The Administrator may require an applicant to submit such documents 
or written statements of fact relevant to the application as he/she 
deems necessary to determine whether the application should be granted. 
The failure of the applicant to provide such documents or statements 
within a reasonable time after being requested to do so shall be deemed 
to be a waiver by the applicant of an opportunity to present such 
documents or facts for consideration by the Administrator in granting or 
denying the application.

[62 FR 13948, Mar. 24, 1997]



Sec. 1301.16  Amendments to and withdrawal of applications.

    (a) An application may be amended or withdrawn without permission of 
the Administrator at any time before the date on which the applicant 
receives an order to show cause pursuant to Sec. 1301.37. An 
application may be amended or withdrawn with permission of the 
Administrator at any time where good cause is shown by the applicant or 
where the amendment or withdrawal is in the public interest.
    (b) After an application has been accepted for filing, the request 
by the applicant that it be returned or the failure of the applicant to 
respond to official correspondence regarding the application, when sent 
by registered or certified mail, return receipt requested, shall be 
deemed to be a withdrawal of the application.

[62 FR 13949, Mar. 24, 1997]



Sec. 1301.17  Special procedures for certain applications.

    (a) If, at the time of application for registration of a new 
pharmacy, the pharmacy has been issued a license from the appropriate 
State licensing agency, the applicant may include with his/her 
application an affidavit as to the existence of the State license in the 
following form:

[[Page 28]]

                       Affidavit for New Pharmacy

    I, --------------------, the -------------------- (Title of officer, 
official, partner, or other position) of -------------------- 
(Corporation, partnership, or sole proprietor), doing business as ------
-------------- (Store name) at -------------------- (Number and Street), 
-------------------- (City) ------------ (State) ------------ (Zip 
code), hereby certify that said store was issued a pharmacy permit No. 
-------- by the ---------------- (Board of Pharmacy or Licensing Agency) 
of the State of ------------ on ------------ (Date).
    This statement is submitted in order to obtain a Drug Enforcement 
Administration registration number. I understand that if any information 
is false, the Administration may immediately suspend the registration 
for this store and commence proceedings to revoke under 21 U.S.C. 824(a) 
because of the danger to public health and safety. I further understand 
that any false information contained in this affidavit may subject me 
personally and the above-named corporation/partnership/business to 
prosecution under 21 U.S.C. 843, the penalties for conviction of which 
include imprisonment for up to 4 years, a fine of not more than $30,000 
or both.
________________________________________________________________________
Signature (Person who signs Application for Registration)
State of________________________________________________________________
County of_______________________________________________________________
    Subscribed to and sworn before me this -------------- day of ------
--------, 19----.
________________________________________________________________________
Notary Public

    (b) Whenever the ownership of a pharmacy is being transferred from 
one person to another, if the transferee owns at least one other 
pharmacy licensed in the same State as the one the ownership of which is 
being transferred, the transferee may apply for registration prior to 
the date of transfer. The Administrator may register the applicant and 
authorize him to obtain controlled substances at the time of transfer. 
Such registration shall not authorize the transferee to dispense 
controlled substances until the pharmacy has been issued a valid State 
license. The transferee shall include with his/her application the 
following affidavit:

                   Affidavit for Transfer of Pharmacy

    I, --------------------, the -------------------- (Title of officer, 
official, partner or other position) of -------------------- 
(Corporation, partnership, or sole proprietor), doing business as ------
-------------- (Store name) hereby certify:
    (1) That said company was issued a pharmacy permit No.------------by 
the -------------------- (Board of Pharmacy of Licensing Agency) of the 
State of ------------ and a DEA Registration Number -------------------- 
for a pharmacy located at -------------------- (Number and Street) ----
-------- (City) ------------ (State) ------------ (Zip Code); and
    (2) That said company is acquiring the pharmacy business of --------
------------ (Name of Seller) doing business as--------------------with 
DEA Registration Number ------------ on or about ------------ (Date of 
Transfer) and that said company has applied (or will apply on ----------
-- (Date) for a pharmacy permit from the board of pharmacy (or licensing 
agency) of the State of ------------ to do business as ----------------
---- (Store name) at -------------------- (Number and Street) ----------
---------- (City) ------------ (State) ------------ (Zip Code).

    This statement is submitted in order to obtain a Drug Enforcement 
Administration registration number.

    I understand that if a DEA registration number is issued, the 
pharmacy may acquire controlled substances but may not dispense them 
until a pharmacy permit or license is issued by the State board of 
pharmacy or licensing agency.
    I understand that if any information is false, the Administration 
may immediately suspend the registration for this store and commence 
proceedings to revoke under 21 U.S.C. 824(a) because of the danger to 
public health and safety. I further understand that any false 
information contained in this affidavit may subject me personally to 
prosecution under 21 U.S.C. 843, the penalties for conviction of which 
include imprisonment for up to 4 years, a fine of not more than $30,000 
or both.

________________________________________________________________________
Signature (Person who signs Application for Registration)
State of________________________________________________________________
County of_______________________________________________________________
    Subscribed to and sworn before me this ---------------- day of ----
--------------, 19----.
________________________________________________________________________
Notary Public

    (c) If at the time of application for a separate registration at a 
long term care facility, the retail pharmacy has been issued a license, 
permit, or other form of authorization from the appropriate State agency 
to install and operate an automated dispensing system

[[Page 29]]

for the dispensing of controlled substances at the long term care 
facility, the applicant must include with his/her application for 
registration (DEA Form 224) an affidavit as to the existence of the 
State authorization. Exact language for this affidavit may be found at 
the DEA Diversion Control Program Web site. The affidavit must include 
the following information:
    (1) The name and title of the corporate officer or official signing 
the affidavit;
    (2) The name of the corporation, partnership or sole proprietorship 
operating the retail pharmacy;
    (3) The name and complete address (including city, state, and Zip 
code) of the retail pharmacy;
    (4) The name and complete address (including city, state, and Zip 
code) of the long term care facility at which DEA registration is 
sought;
    (5) Certification that the named retail pharmacy has been authorized 
by the state Board of Pharmacy or licensing agency to install and 
operate an automated dispensing system for the dispensing of controlled 
substances at the named long term care facility (including the license 
or permit number, if applicable);
    (6) The date on which the authorization was issued;
    (7) Statements attesting to the following:
    (i) The affidavit is submitted to obtain a Drug Enforcement 
Administration registration number;
    (ii) If any material information is false, the Administrator may 
commence proceedings to deny the application under section 304 of the 
Act (21 U.S.C. 824(a));
    (iii) Any false or fraudulent material information contained in this 
affidavit may subject the person signing this affidavit and the above-
named corporation/partnership/business to prosecution under section 403 
of the Act (21 U.S.C. 843);
    (8) Signature of the person authorized to sign the Application for 
Registration for the named retail pharmacy;
    (9) Notarization of the affidavit.
    (d) The Administrator shall follow the normal procedures for 
approving an application to verify the statements in the affidavit. If 
the statements prove to be false, the Administrator may revoke the 
registration on the basis of section 304(a)(1) of the Act (21 U.S.C. 
824(a)(1)) and suspend the registration immediately by pending 
revocation on the basis of section 304(d) of the Act (21 U.S.C. 824(d)). 
At the same time, the Administrator may seize and place under seal all 
controlled substances possessed by the applicant under section 304(f) of 
the Act (21 U.S.C. 824(f)). Intentional misuse of the affidavit 
procedure may subject the applicant to prosecution for fraud under 
section 403(a)(4) of the Act (21 U.S.C. 843(a)(4)), and obtaining 
controlled substances through registration by fraudulent means may 
subject the applicant to prosecution under section 403(a)(3) of the Act 
(21 U.S.C. 843(a)(3)). The penalties for conviction of either offense 
include imprisonment for up to 4 years, a fine not exceeding $30,000 or 
both.

[62 FR 13949, Mar. 24, 1997, as amended at 70 FR 25465, May 13, 2005]



Sec. 1301.18  Research protocols.

    (a) A protocol to conduct research with controlled substances listed 
in Schedule I shall be in the following form and contain the following 
information where applicable:
    (1) Investigator:
    (i) Name, address, and DEA registration number; if any.
    (ii) Institutional affiliation.
    (iii) Qualifications, including a curriculum vitae and an 
appropriate bibliography (list of publications).
    (2) Research project:
    (i) Title of project.
    (ii) Statement of the purpose.
    (iii) Name of the controlled substances or substances involved and 
the amount of each needed.
    (iv) Description of the research to be conducted, including the 
number and species of research subjects, the dosage to be administered, 
the route and method of administration, and the duration of the project.
    (v) Location where the research will be conducted.
    (vi) Statement of the security provisions for storing the controlled 
substances (in accordance with Sec. 1301.75) and for dispensing the 
controlled substances in order to prevent diversion.

[[Page 30]]

    (vii) If the investigator desires to manufacture or import any 
controlled substance listed in paragraph (a)(2)(iii) of this section, a 
statement of the quantity to be manufactured or imported and the sources 
of the chemicals to be used or the substance to be imported.
    (3) Authority:
    (i) Institutional approval.
    (ii) Approval of a Human Research Committee for human studies.
    (iii) Indication of an approved active Notice of Claimed 
Investigational Exemption for a New Drug (number).
    (iv) Indication of an approved funded grant (number), if any.
    (b) In the case of a clinical investigation with controlled 
substances listed in Schedule I, the applicant shall submit three copies 
of a Notice of Claimed Investigational Exemption for a New Drug (IND) 
together with a statement of the security provisions (as proscribed in 
paragraph (a)(2)(vi) of this section for a research protocol) to, and 
have such submission approved by, the Food and Drug Administration as 
required in 21 U.S.C. 355(i) and Sec. 130.3 of this title. Submission 
of this Notice and statement to the Food and Drug Administration shall 
be in lieu of a research protocol to the Administration as required in 
paragraph (a) of this section. The applicant, when applying for 
registration with the Administration, shall indicate that such notice 
has been submitted to the Food and Drug Administration by submitting to 
the Administration with his/her DEA Form 225 three copies of the 
following certificate:

    I hereby certify that on -------------------- (Date), pursuant to 21 
U.S.C. 355(i) and 21 CFR 130.3, I, -------------------- (Name and 
Address of IND Sponsor) submitted a Notice of Claimed Investigational 
Exemption for a New Drug (IND) to the Food and Drug Administration for:

________________________________________________________________________
(Name of Investigational Drug).

________________________________________________________________________
(Date)

________________________________________________________________________
(Signature of Applicant).

    (c) In the event that the registrant desires to increase the 
quantity of a controlled substance used for an approved research 
project, he/she shall submit a request to the Registration Unit, Drug 
Enforcement Administration, by registered mail, return receipt 
requested. See the Table of DEA Mailing Addresses in Sec. 1321.01 of 
this chapter for the current mailing address. The request shall contain 
the following information: DEA registration number; name of the 
controlled substance or substances and the quantity of each authorized 
in the approved protocol; and the additional quantity of each desired. 
Upon return of the receipt, the registrant shall be authorized to 
purchase the additional quantity of the controlled substance or 
substances specified in the request. The Administration shall review the 
letter and forward it to the Food and Drug Administration together with 
the Administration comments. The Food and Drug Administration shall 
approve or deny the request as an amendment to the protocol and so 
notify the registrant. Approval of the letter by the Food and Drug 
Administration shall authorize the registrant to use the additional 
quantity of the controlled substance in the research project.
    (d) In the event the registrant desires to conduct research beyond 
the variations provided in the registrant's approved protocol (excluding 
any increase in the quantity of the controlled substance requested for 
his/her research project as outlined in paragraph (c) of this section), 
he/she shall submit three copies of a supplemental protocol in 
accordance with paragraph (a) of this section describing the new 
research and omitting information in the supplemental protocol which has 
been stated in the original protocol. Supplemental protocols shall be 
processed and approved or denied in the same manner as original research 
protocols.

[62 FR 13949, Mar. 24, 1997, as amended at 75 FR 10676, Mar. 9, 2010]



Sec. 1301.19  Special requirements for online pharmacies.

    (a) A pharmacy that has been issued a registration under Sec. 
1301.13 may request that the Administrator modify its registration to 
authorize the pharmacy to dispense controlled substances by means of the 
Internet as an online pharmacy. The Administrator may deny an 
application for a modification

[[Page 31]]

of registration if the Administrator determines that the issuance of a 
modification would be inconsistent with the public interest. In 
determining the public interest, the Administrator will consider the 
factors listed in section 303(f) of the Act (21 U.S.C. 823(f)).
    (b) Each online pharmacy shall comply with the requirements of State 
law concerning licensure of pharmacies in each State from which it, and 
in each State to which it, delivers, distributes, or dispenses, or 
offers to deliver, distribute, or dispense controlled substances by 
means of the Internet.
    (c) Application for a modified registration authorizing the 
dispensing of controlled substances by means of the Internet will be 
made by an online application process as specified in Sec. 1301.13 of 
this part. Subsequent online pharmacy registration renewals will be 
accomplished by an online process.
    (d) A pharmacy that seeks to discontinue its modification of 
registration authorizing it to dispense controlled substances by means 
of the Internet as an online pharmacy (but continue its business 
activity as a non-online pharmacy) shall so notify the Administrator by 
requesting to modify its registration to reflect the appropriate 
business activity. Once the registration has been so changed, the 
pharmacy may no longer dispense controlled substances by means of the 
Internet. A pharmacy that has so changed its registration status back to 
that of a non-online pharmacy remains responsible for submitting reports 
in accordance with Sec. 1304.55 of this chapter with respect to any 
controlled substances that it dispensed while it was registered with a 
modification authorizing it to operate as an online pharmacy.
    (e) Registrants applying for modified registrations under this 
section must comply with notification and reporting requirements set 
forth in Sec. Sec. 1304.40, 1304.45, 1304.50, and 1304.55 of this 
chapter.
    (f) No person (including a registrant) required to obtain a 
modification of a registration under Sec. Sec. 1301.11(b) and 1301.13 
of this part authorizing it to operate as an online pharmacy may engage 
in any activity for which such modification of registration is required 
until the application for such modified registration is granted and an 
active Certificate of Registration indicating the modification of the 
registration has been issued by the Administrator to such person.

[74 FR 15622, Apr. 6, 2009]

                   Exceptions to Registration and Fees



Sec. 1301.21  Exemption from fees.

    (a) The Administrator shall exempt from payment of an application 
fee for registration or reregistration:
    (1) Any hospital or other institution which is operated by an agency 
of the United States (including the U.S. Army, Navy, Marine Corps., Air 
Force, and Coast Guard), of any State, or any political subdivision or 
agency thereof.
    (2) Any individual practitioner who is required to obtain an 
individual registration in order to carry out his or her duties as an 
official of an agency of the United States (including the U.S. Army, 
Navy, Marine Corps, Air Force, and Coast Guard), of any State, or any 
political subdivision or agency thereof.
    (b) In order to claim exemption from payment of a registration or 
reregistration application fee, the registrant shall have completed the 
certification on the appropriate application form, wherein the 
registrant's superior (if the registrant is an individual) or officer 
(if the registrant is an agency) certifies to the status and address of 
the registrant and to the authority of the registrant to acquire, 
possess, or handle controlled substances.
    (c) Exemption from payment of a registration or reregistration 
application fee does not relieve the registrant of any other 
requirements or duties prescribed by law.

[62 FR 13950, Mar. 24, 1997]



Sec. 1301.22  Exemption of agents and employees; affiliated practitioners.

    (a) The requirement of registration is waived for any agent or 
employee of a person who is registered to engage in any group of 
independent activities, if such agent or employee is acting in the usual 
course of his/her business or employment.

[[Page 32]]

    (b) An individual practitioner who is an agent or employee of 
another practitioner (other than a mid-level practitioner) registered to 
dispense controlled substances may, when acting in the normal course of 
business or employment, administer or dispense (other than by issuance 
of prescription) controlled substances if and to the extent that such 
individual practitioner is authorized or permitted to do so by the 
jurisdiction in which he or she practices, under the registration of the 
employer or principal practitioner in lieu of being registered him/
herself.
    (c) An individual practitioner who is an agent or employee of a 
hospital or other institution may, when acting in the normal course of 
business or employment, administer, dispense, or prescribe controlled 
substances under the registration of the hospital or other institution 
which is registered in lieu of being registered him/herself, provided 
that:
    (1) Such dispensing, administering or prescribing is done in the 
usual course of his/her professional practice;
    (2) Such individual practitioner is authorized or permitted to do so 
by the jurisdiction in which he/she is practicing;
    (3) The hospital or other institution by whom he/she is employed has 
verified that the individual practitioner is so permitted to dispense, 
administer, or prescribe drugs within the jurisdiction;
    (4) Such individual practitioner is acting only within the scope of 
his/her employment in the hospital or institution;
    (5) The hospital or other institution authorizes the individual 
practitioner to administer, dispense or prescribe under the hospital 
registration and designates a specific internal code number for each 
individual practitioner so authorized. The code number shall consist of 
numbers, letters, or a combination thereof and shall be a suffix to the 
institution's DEA registration number, preceded by a hyphen (e.g., 
APO123456-10 or APO123456-A12); and
    (6) A current list of internal codes and the corresponding 
individual practitioners is kept by the hospital or other institution 
and is made available at all times to other registrants and law 
enforcement agencies upon request for the purpose of verifying the 
authority of the prescribing individual practitioner.

[62 FR 13950, Mar. 24, 1997]



Sec. 1301.23  Exemption of certain military and other personnel.

    (a) The requirement of registration is waived for any official of 
the U.S. Army, Navy, Marine Corps, Air Force, Coast Guard, Public Health 
Service, or Bureau of Prisons who is authorized to prescribe, dispense, 
or administer, but not to procure or purchase, controlled substances in 
the course of his/her official duties. Such officials shall follow 
procedures set forth in part 1306 of this chapter regarding 
prescriptions, but shall state the branch of service or agency (e.g., 
``U.S. Army'' or ``Public Health Service'') and the service 
identification number of the issuing official in lieu of the 
registration number required on prescription forms. The service 
identification number for a Public Health Service employee is his/her 
Social Security identification number.
    (b) The requirement of registration is waived for any official or 
agency of the U.S. Army, Navy, Marine Corps, Air Force, Coast Guard, or 
Public Health Service who or which is authorized to import or export 
controlled substances in the course of his/her official duties.
    (c) If any official exempted by this section also engages as a 
private individual in any activity or group of activities for which 
registration is required, such official shall obtain a registration for 
such private activities.

[62 FR 13951, Mar. 24, 1997]



Sec. 1301.24  Exemption of law enforcement officials.

    (a) The requirement of registration is waived for the following 
persons in the circumstances described in this section:
    (1) Any officer or employee of the Administration, any officer of 
the U.S. Customs Service, any officer or employee of the United States 
Food and Drug Administration, and any other Federal officer who is 
lawfully engaged in the enforcement of any Federal law relating to 
controlled substances,

[[Page 33]]

drugs or customs, and is duly authorized to possess or to import or 
export controlled substances in the course of his/her official duties; 
and
    (2) Any officer or employee of any State, or any political 
subdivision or agency thereof, who is engaged in the enforcement of any 
State or local law relating to controlled substances and is duly 
authorized to possess controlled substances in the course of his/her 
official duties.
    (b) Any official exempted by this section may, when acting in the 
course of his/her official duties, procure any controlled substance in 
the course of an inspection, in accordance with Sec. 1316.03(d) of this 
chapter, or in the course of any criminal investigation involving the 
person from whom the substance was procured, and may possess any 
controlled substance and distribute any such substance to any other 
official who is also exempted by this section and acting in the course 
of his/her official duties.
    (c) In order to enable law enforcement agency laboratories, 
including laboratories of the Administration, to obtain and transfer 
controlled substances for use as standards in chemical analysis, such 
laboratories shall obtain annually a registration to conduct chemical 
analysis. Such laboratories shall be exempted from payment of a fee for 
registration. Laboratory personnel, when acting in the scope of their 
official duties, are deemed to be officials exempted by this section and 
within the activity described in section 515(d) of the Act (21 U.S.C. 
885(d)). For purposes of this paragraph, laboratory activities shall not 
include field or other preliminary chemical tests by officials exempted 
by this section.
    (d) In addition to the activities authorized under a registration to 
conduct chemical analysis pursuant to Sec. 1301.13(e)(1)(ix), 
laboratories of the Administration shall be authorized to manufacture or 
import controlled substances for any lawful purpose, to distribute or 
export such substances to any person, and to import and export such 
substances in emergencies without regard to the requirements of part 
1312 of this chapter if a report concerning the importation or 
exportation is made to the Drug Operations Section of the Administration 
within 30 days of such importation or exportation.

[62 FR 13951, Mar. 24, 1997]



Sec. 1301.25  Registration regarding ocean vessels, aircraft, and other
entities.

    (a) If acquired by and dispensed under the general supervision of a 
medical officer described in paragraph (b) of this section, or the 
master or first officer of the vessel under the circumstances described 
in paragraph (d) of this section, controlled substances may be held for 
stocking, be maintained in, and dispensed from medicine chests, first 
aid packets, or dispensaries:
    (1) On board any vessel engaged in international trade or in trade 
between ports of the United States and any merchant vessel belonging to 
the U.S. Government;
    (2) On board any aircraft operated by an air carrier under a 
certificate of permit issued pursuant to the Federal Aviation Act of 
1958 (49 U.S.C. 1301); and
    (3) In any other entity of fixed or transient location approved by 
the Administrator as appropriate for application of this section (e.g., 
emergency kits at field sites of an industrial firm).
    (b) A medical officer shall be:
    (1) Licensed in a state as a physician;
    (2) Employed by the owner or operator of the vessel, aircraft or 
other entity; and
    (3) Registered under the Act at either of the following locations:
    (i) The principal office of the owner or operator of the vessel, 
aircraft or other entity or
    (ii) At any other location provided that the name, address, 
registration number and expiration date as they appear on his/her 
Certificate of Registration (DEA Form 223) for this location are 
maintained for inspection at said principal office in a readily 
retrievable manner.
    (c) A registered medical officer may serve as medical officer for 
more than one vessel, aircraft, or other entity under a single 
registration, unless he/she serves as medical officer for more than one 
owner or operator, in which case he/she shall either maintain a separate 
registration at the location of the principal office of each such owner

[[Page 34]]

or operator or utilize one or more registrations pursuant to paragraph 
(b)(3)(ii) of this section.
    (d) If no medical officer is employed by the owner or operator of a 
vessel, or in the event such medical officer is not accessible and the 
acquisition of controlled substances is required, the master or first 
officer of the vessel, who shall not be registered under the Act, may 
purchase controlled substances from a registered manufacturer or 
distributor, or from an authorized pharmacy as described in paragraph 
(f) of this section, by following the procedure outlined below:
    (1) The master or first officer of the vessel must personally appear 
at the vendor's place of business, present proper identification (e.g., 
Seaman's photographic identification card) and a written requisition for 
the controlled substances.
    (2) The written requisition must be on the vessel's official 
stationery or purchase order form and must include the name and address 
of the vendor, the name of the controlled substance, description of the 
controlled substance (dosage form, strength and number or volume per 
container) number of containers ordered, the name of the vessel, the 
vessel's official number and country of registry, the owner or operator 
of the vessel, the port at which the vessel is located, signature of the 
vessel's officer who is ordering the controlled substances and the date 
of the requisition.
    (3) The vendor may, after verifying the identification of the 
vessel's officer requisitioning the controlled substances, deliver the 
control substances to that officer. The transaction shall be documented, 
in triplicate, on a record of sale in a format similar to that outlined 
in paragraph (d)(4) of this section. The vessel's requisition shall be 
attached to copy 1 of the record of sale and filed with the controlled 
substances records of the vendor, copy 2 of the record of sale shall be 
furnished to the officer of the vessel and retained aboard the vessel, 
copy 3 of the record of sale shall be forwarded to the nearest DEA 
Division Office within 15 days after the end of the month in which the 
sale is made.
    (4) The vendor's record of sale should be similar to, and must 
include all the information contained in, the below listed format.

                Sale of Controlled Substances to Vessels

(Name of registrant)____________________________________________________

(Address of registrant)_________________________________________________

(DEA registration number)_______________________________________________

--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                 Number of                                                Packages
                          Line No.                            packages ordered   Size of packages   Name of product     distributed     Date distributed
--------------------------------------------------------------------------------------------------------------------------------------------------------
1..........................................................  .................  .................  ................  .................  ................
2..........................................................  .................  .................  ................  .................  ................
3..........................................................  .................  .................  ................  .................  ................
--------------------------------------------------------------------------------------------------------------------------------------------------------
Footnote: Line numbers may be continued according to needs of the vendor.

Number of lines completed_______________________________________________
Name of vessel__________________________________________________________
Vessel's official number________________________________________________
Vessel's country of registry____________________________________________
Owner or operator of the vessel_________________________________________

Name and title of vessel's officer who presented the requisition ------
          --
Signature of vessel's officer who presented the requisition --------

    (e) Any medical officer described in paragraph (b) of this section 
shall, in addition to complying with all requirements and duties 
prescribed for registrants generally, prepare an annual report as of the 
date on which his/her registration expires, which shall give in detail 
an accounting for each vessel, aircraft, or other entity, and a summary 
accounting for all vessels, aircraft, or other entities under his/her 
supervision for all controlled substances purchased, dispensed or 
disposed of during the year. The medical officer shall maintain this 
report with other records required to be kept under the Act and, upon 
request, deliver a copy of the report to the Administration. The medical 
officer need not be present when controlled substances are dispensed, if 
the person who actually dispensed the controlled substances is 
responsible to the medical officer to justify his/her actions.

[[Page 35]]

    (f) Any registered pharmacy that wishes to distribute controlled 
substances pursuant to this section shall be authorized to do so, 
provided:
    (1) The registered pharmacy notifies the nearest Division Office of 
the Administration of its intention to so distribute controlled 
substances prior to the initiation of such activity. This notification 
shall be by registered mail and shall contain the name, address, and 
registration number of the pharmacy as well as the date upon which such 
activity will commence; and
    (2) Such activity is authorized by state law; and
    (3) The total number of dosage units of all controlled substances 
distributed by the pharmacy during any calendar year in which the 
pharmacy is registered to dispense does not exceed the limitations 
imposed upon such distribution by Sec. 1307.11(a)(4) and (b) of this 
chapter.
    (g) Owners or operators of vessels, aircraft, or other entities 
described in this section shall not be deemed to possess or dispense any 
controlled substance acquired, stored and dispensed in accordance with 
this section. Additionally, owners or operators of vessels, aircraft, or 
other entities described in this section or in Article 32 of the Single 
Convention on Narcotic Drugs, 1961, or in Article 14 of the Convention 
on Psychotropic Substances, 1971, shall not be deemed to import or 
export any controlled substances purchased and stored in accordance with 
that section or applicable article.
    (h) The Master of a vessel shall prepare a report for each calendar 
year which shall give in detail an accounting for all controlled 
substances purchased, dispensed, or disposed of during the year. The 
Master shall file this report with the medical officer employed by the 
owner or operator of his/her vessel, if any, or, if not, he/she shall 
maintain this report with other records required to be kept under the 
Act and, upon request, deliver a copy of the report to the 
Administration.
    (i) Controlled substances acquired and possessed in accordance with 
this section shall not be distributed to persons not under the general 
supervision of the medical officer employed by the owner or operator of 
the vessel, aircraft, or other entity, except in accordance with Sec. 
1307.21 of this chapter.

[62 FR 13951, Mar. 24, 1997]



Sec. 1301.26  Exemptions from import or export requirements for personal
medical use.

    Any individual who has in his/her possession a controlled substance 
listed in schedules II, III, IV, or V, which he/she has lawfully 
obtained for his/her personal medical use, or for administration to an 
animal accompanying him/her, may enter or depart the United States with 
such substance notwithstanding sections 1002-1005 of the Act (21 U.S.C. 
952-955), provided the following conditions are met:
    (a) The controlled substance is in the original container in which 
it was dispensed to the individual; and
    (b) The individual makes a declaration to an appropriate official of 
the Bureau of Customs and Border Protection stating:
    (1) That the controlled substance is possessed for his/her personal 
use, or for an animal accompanying him/her; and
    (2) The trade or chemical name and the symbol designating the 
schedule of the controlled substance if it appears on the container 
label, or, if such name does not appear on the label, the name and 
address of the pharmacy or practitioner who dispensed the substance and 
the prescription number.
    (c) In addition to (and not in lieu of) the foregoing requirements 
of this section, a United States resident may import into the United 
States no more than 50 dosage units combined of all such controlled 
substances in the individual's possession that were obtained abroad for 
personal medical use. (For purposes of this section, a United States 
resident is a person whose residence (i.e., place of general abode--
meaning one's principal, actual dwelling place in fact, without regard 
to intent) is in the United States.) This 50 dosage unit limitation does 
not apply to controlled substances lawfully obtained in the United 
States pursuant to a prescription issued by a DEA registrant.

[69 FR 55347, Sept. 14, 2004]

[[Page 36]]



Sec. 1301.27  Separate registration by retail pharmacies for 
installation and operation of automated dispensing systems at long

term care facilities.

    (a) A retail pharmacy may install and operate automated dispensing 
systems, as defined in Sec. 1300.01 of this chapter, at long term care 
facilities, under the requirements of Sec. 1301.17. No person other 
than a registered retail pharmacy may install and operate an automated 
dispensing system at a long term care facility.
    (b) Retail pharmacies installing and operating automated dispensing 
systems at long term care facilities must maintain a separate 
registration at the location of each long term care facility at which 
automated dispensing systems are located. If more than one registered 
retail pharmacy operates automated dispensing systems at the same long 
term care facility, each retail pharmacy must maintain a registration at 
the long term care facility.
    (c) A registered retail pharmacy applying for a separate 
registration to operate an automated dispensing system for the 
dispensing of controlled substances at a long term care facility is 
exempt from application fees for any such additional registrations.

[70 FR 25465, May 13, 2005]



Sec. 1301.28  Exemption from separate registration for practitioners
dispensing or prescribing Schedule III, IV, or V narcotic controlled

drugs approved by the Food and Drug Administration specifically for use
in maintenance or detoxification treatment.

    (a) An individual practitioner may dispense or prescribe Schedule 
III, IV, or V narcotic controlled drugs or combinations of narcotic 
controlled drugs which have been approved by the Food and Drug 
Administration (FDA) specifically for use in maintenance or 
detoxification treatment without obtaining the separate registration 
required by Sec. 1301.13(e) if all of the following conditions are met:
    (1) The individual practitioner meets the conditions specified in 
paragraph (b) of this section.
    (2) The narcotic drugs or combination of narcotic drugs meet the 
conditions specified in paragraph (c) of this section.
    (3) The individual practitioner is in compliance with either 
paragraph (d) or paragraph (e) of this section.
    (b)(1) The individual practitioner must submit notification to the 
Secretary of Health and Human Services stating the individual 
practitioner's intent to dispense or prescribe narcotic drugs under 
paragraph (a) of this section. The notice must contain all of the 
following certifications:
    (i) The individual practitioner is registered under Sec. 1301.13 as 
an individual practitioner and is a ``qualifying physician'' as defined 
in section 303(g)(2)(G) of the Act (21 U.S.C. 823(g)(2)(G)).
    (ii) The individual practitioner has the capacity to refer the 
patients to whom the individual practitioner will provide narcotic drugs 
or combinations of narcotic drugs for appropriate counseling and other 
appropriate ancillary services.
    (iii) The total number of patients to whom the individual 
practitioner will provide narcotic drugs or combinations of narcotic 
drugs under this section will not exceed 30 at any one time unless, not 
sooner than 1 year after the date on which the practitioner submitted 
the initial notification to the Secretary of Health and Human Services, 
the practitioner submits a second notification to the Secretary of the 
need and intent of the practitioner to treat up to 100 patients. A 
second notification under this subparagraph shall contain the 
certifications required by subparagraphs (i) and (ii) of this paragraph. 
The Secretary of Health and Human Services may promulgate regulations to 
change the total number of patients.
    (2) If an individual practitioner wishes to prescribe or dispense 
narcotic drugs pursuant to paragraph (e) of this section, the individual 
practitioner must provide the Secretary of Health and Human Services the 
following:
    (i) Notification as required under paragraph (b)(1) of this section 
in writing, stating the individual practitioner's name and DEA 
registration number issued under Sec. 1301.13.
    (ii) If the individual practitioner is a member of a group practice, 
the names of the other individual practitioners in

[[Page 37]]

the group and the DEA registration numbers issued to the other 
individual practitioners under Sec. 1301.13.
    (c) The narcotic drugs or combination of narcotic drugs to be 
dispensed or prescribed under this section must meet all of the 
following conditions:
    (1) The drugs or combination of drugs have been approved for use in 
``maintenance treatment'' or ``detoxification treatment'' under the 
Federal Food, Drug, and Cosmetic Act or section 351 of the Public Health 
Service Act.
    (2) The drugs or combination of drugs have not been the subject of 
an adverse determination by the Secretary of Health and Human Services, 
after consultation with the Attorney General, that the use of the drugs 
or combination of drugs requires additional standards respecting the 
qualifications of practitioners or the quantities of the drugs that may 
be provided for unsupervised use.
    (d)(1) After receiving the notification submitted under paragraph 
(b) of this section, the Secretary of Health and Human Services will 
forward a copy of the notification to the Administrator. The Secretary 
of Health and Human Services will have 45 days from the date of receipt 
of the notification to make a determination of whether the individual 
practitioner involved meets all requirements for a waiver under section 
303(g)(2)(B) of the Act (21 U.S.C. 823(g)(2)(B)). Health and Human 
Services will notify DEA of its determination regarding the individual 
practitioner. If the individual practitioner has the appropriate 
registration under Sec. 1301.13, then the Administrator will issue the 
practitioner an identification number as soon as one of the following 
conditions occurs:
    (i) The Administrator receives a positive determination from the 
Secretary of Health and Human Services before the conclusion of the 45-
day review period, or
    (ii) The 45-day review period has concluded and no determination by 
the Secretary of Health and Human Services has been made.
    (2) If the Secretary denies certification to an individual 
practitioner or withdraws such certification once it is issued, then DEA 
will not issue the individual practitioner an identification number, or 
will withdraw the identification number if one has been issued.
    (3) The individual practitioner must include the identification 
number on all records when dispensing and on all prescriptions when 
prescribing narcotic drugs under this section.
    (e) An individual practitioner may begin to prescribe or dispense 
narcotic drugs to a specific individual patient under this section 
before receiving an identification number from the Administrator if the 
following conditions are met:
    (1) The individual practitioner has submitted a written notification 
under paragraph (b) of this section in good faith to the Secretary of 
Health and Human Services.
    (2) The individual practitioner reasonably believes that the 
conditions specified in paragraphs (b) and (c) of this section have been 
met.
    (3) The individual practitioner reasonably believes that the 
treatment of an individual patient would be facilitated if narcotic 
drugs are prescribed or dispensed under this section before the sooner 
of:
    (i) Receipt of an identification number from the Administrator, or
    (ii) Expiration of the 45-day period.
    (4) The individual practitioner has notified both the Secretary of 
Health and Human Services and the Administrator of his or her intent to 
begin prescribing or dispensing the narcotic drugs before expiration of 
the 45-day period.
    (5) The Secretary has not notified the registrant that he/she is not 
qualified under paragraph (d) of this section.
    (6) The individual practitioner has the appropriate registration 
under Sec. 1301.13.
    (f) If an individual practitioner dispenses or prescribes Schedule 
III, IV, or V narcotic drugs approved by the Food and Drug 
Administration specifically for maintenance or detoxification treatment 
in violation of any of the conditions specified in paragraphs (b), (c) 
or (e) of this section, the Administrator may revoke the individual 
practitioner's registration in accordance with Sec. 1301.36.

[70 FR 36342, June 23, 2005, as amended at 73 FR 29688, May 22, 2008]

[[Page 38]]

  Action on Application for Registration: Revocation or Suspension of 
                              Registration



Sec. 1301.31  Administrative review generally.

    The Administrator may inspect, or cause to be inspected, the 
establishment of an applicant or registrant, pursuant to subpart A of 
part 1316 of this chapter. The Administrator shall review the 
application for registration and other information gathered by the 
Administrator regarding an applicant in order to determine whether the 
applicable standards of section 303 (21 U.S.C. 823) or section 1008 (21 
U.S.C. 958) of the Act have been met by the applicant.

[62 FR 13953, Mar. 24, 1997]



Sec. 1301.32  Action on applications for research in Schedule I 
substances.

    (a) In the case of an application for registration to conduct 
research with controlled substances listed in Schedule I, the 
Administrator shall process the application and protocol and forward a 
copy of each to the Secretary of Health and Human Services (Secretary) 
within 7 days after receipt. The Secretary shall determine the 
qualifications and competency of the applicant, as well as the merits of 
the protocol (and shall notify the Administrator of his/her 
determination) within 21 days after receipt of the application and 
complete protocol, except that in the case of a clinical investigation, 
the Secretary shall have 30 days to make such determination and notify 
the Administrator. The Secretary, in determining the merits of the 
protocol, shall consult with the Administrator as to effective 
procedures to safeguard adequately against diversion of such controlled 
substances from legitimate medical or scientific use.
    (b) An applicant whose protocol is defective shall be notified by 
the Secretary within 21 days after receipt of such protocol from the 
Administrator (or in the case of a clinical investigation within 30 
days), and he/she shall be requested to correct the existing defects 
before consideration shall be given to his/her submission.
    (c) If the Secretary determines the applicant qualified and 
competent and the research protocol meritorious, he/she shall notify the 
Administrator in writing of such determination. The Administrator shall 
issue a certificate of registration within 10 days after receipt of this 
notice, unless he/she determines that the certificate of registration 
should be denied on a ground specified in section 304(a) of the Act (21 
U.S.C. 824(a)). In the case of a supplemental protocol, a replacement 
certificate of registration shall be issued by the Administrator.
    (d) If the Secretary determines that the protocol is not meritorious 
and/or the applicant is not qualified or competent, he/she shall notify 
the Administrator in writing setting forth the reasons for such 
determination. If the Administrator determines that grounds exist for 
the denial of the application, he/she shall within 10 days issue an 
order to show cause pursuant to Sec. 1301.37 and, if requested by the 
applicant, hold a hearing on the application pursuant to Sec. 1301.41. 
If the grounds for denial of the application include a determination by 
the Secretary, the Secretary or his duly authorized agent shall furnish 
testimony and documents pertaining to his determination at such hearing.
    (e) Supplemental protocols will be processed in the same manner as 
original research protocols. If the processing of an application or 
research protocol is delayed beyond the time limits imposed by this 
section, the applicant shall be so notified in writing.

[62 FR 13953, Mar. 24, 1997]



Sec. 1301.33  Application for bulk manufacture of Schedule I and II 
substances.

    (a) In the case of an application for registration or reregistration 
to manufacture in bulk a basic class of controlled substance listed in 
Schedule I or II, the Administrator shall, upon the filing of such 
application, publish in the Federal Register a notice naming the 
applicant and stating that such applicant has applied to be registered 
as a bulk manufacturer of a basic class of narcotic or nonnarcotic 
controlled substance, which class shall be identified. A copy of said 
notice shall be mailed simultaneously to each person registered as a 
bulk manufacturer of that

[[Page 39]]

basic class and to any other applicant therefor. Any such person may, 
within 60 days from the date of publication of the notice in the Federal 
Register, file with the Administrator written comments on or objections 
to the issuance of the proposed registration.
    (b) In order to provide adequate competition, the Administrator 
shall not be required to limit the number of manufacturers in any basic 
class to a number less than that consistent with maintenance of 
effective controls against diversion solely because a smaller number is 
capable of producing an adequate and uninterrupted supply.
    (c) This section shall not apply to the manufacture of basic classes 
of controlled substances listed in Schedules I or II as an incident to 
research or chemical analysis as authorized in Sec. 1301.13(e)(1).

[62 FR 13953, Mar. 24, 1997]



Sec. 1301.34  Application for importation of Schedule I and II 
substances.

    (a) In the case of an application for registration or reregistration 
to import a controlled substance listed in Schedule I or II, under the 
authority of section 1002(a)(2)(B) of the Act (21 U.S.C. 952(a)(2)(B)), 
the Administrator shall, upon the filing of such application, publish in 
the Federal Register a notice naming the applicant and stating that such 
applicant has applied to be registered as an importer of a Schedule I or 
II controlled substance, which substance shall be identified. A copy of 
said notice shall be mailed simultaneously to each person registered as 
a bulk manufacturer of that controlled substance and to any other 
applicant therefor. Any such person may, within 30 days from the date of 
publication of the notice in the Federal Register, file written comments 
on or objections to the issuance of the proposed registration, and may, 
at the same time, file a written request for a hearing on the 
application pursuant to Sec. 1301.43. If a hearing is requested, the 
Administrator shall hold a hearing on the application in accordance with 
Sec. 1301.41. Notice of the hearing shall be published in the Federal 
Register, and shall be mailed simultaneously to the applicant and to all 
persons to whom notice of the application was mailed. Any such person 
may participate in the hearing by filing a notice of appearance in 
accordance with Sec. 1301.43 of this chapter. Notice of the hearing 
shall contain a summary of all comments and objections filed regarding 
the application and shall state the time and place for the hearing, 
which shall not be less than 30 days after the date of publication of 
such notice in the Federal Register. A hearing pursuant to this section 
may be consolidated with a hearing held pursuant to Sec. 1301.35 or 
Sec. 1301.36 of this part.
    (b) The Administrator shall register an applicant to import a 
controlled substance listed in Schedule I or II if he/she determines 
that such registration is consistent with the public interest and with 
U.S. obligations under international treaties, conventions, or protocols 
in effect on May 1, 1971. In determining the public interest, the 
following factors shall be considered:
    (1) Maintenance of effective controls against diversion of 
particular controlled substances and any controlled substance in 
Schedule I or II compounded therefrom into other than legitimate 
medical, scientific research, or industrial channels, by limiting the 
importation and bulk manufacture of such controlled substances to a 
number of establishments which can produce an adequate and uninterrupted 
supply of these substances under adequately competitive conditions for 
legitimate medical, scientific, research, and industrial purposes;
    (2) Compliance with applicable State and local law;
    (3) Promotion of technical advances in the art of manufacturing 
these substances and the development of new substances;
    (4) Prior conviction record of applicant under Federal and State 
laws relating to the manufacture, distribution, or dispensing of such 
substances;
    (5) Past experience in the manufacture of controlled substances, and 
the existence in the establishment of effective control against 
diversion;
    (6) That the applicant will be permitted to import only:
    (i) Such amounts of crude opium, poppy straw, concentrate of poppy 
straw, and coca leaves as the Administrator finds to be necessary to 
provide

[[Page 40]]

for medical, scientific, or other legitimate purposes; or
    (ii) Such amounts of any controlled substances listed in Schedule I 
or II as the Administrator shall find to be necessary to provide for the 
medical, scientific, or other legitimate needs of the United States 
during an emergency in which domestic supplies of such substances are 
found by the Administrator to be inadequate; or
    (iii) Such amounts of any controlled substance listed in Schedule I 
or II as the Administrator shall find to be necessary to provide for the 
medical, scientific, or other legitimate needs of the United States in 
any case in which the Administrator finds that competition among 
domestic manufacturers of the controlled substance is inadequate and 
will not be rendered adequate by the registration of additional 
manufacturers under section 303 of the Act (21 U.S.C. 823); or
    (iv) Such limited quantities of any controlled substance listed in 
Schedule I or II as the Administrator shall find to be necessary for 
scientific, analytical or research uses; and
    (7) Such other factors as may be relevant to and consistent with the 
public health and safety.
    (c) In determining whether the applicant can and will maintain 
effective controls against diversion within the meaning of paragraph (b) 
of this section, the Administrator shall consider among other factors:
    (1) Compliance with the security requirements set forth in 
Sec. Sec. 1301.71-1301.76; and
    (2) Employment of security procedures to guard against in-transit 
losses within and without the jurisdiction of the United States.
    (d) In determining whether competition among the domestic 
manufacturers of a controlled substance is adequate within the meaning 
of paragraphs (b)(1) and (b)(6)(iii) of this section, as well as section 
1002(a)(2)(B) of the Act (21 U.S.C. 952(a)(2)(B)), the Administrator 
shall consider:
    (1) The extent of price rigidity in the light of changes in:
    (i) raw materials and other costs and
    (ii) conditions of supply and demand;
    (2) The extent of service and quality competition among the domestic 
manufacturers for shares of the domestic market including:
    (i) Shifts in market shares and
    (ii) Shifts in individual customers among domestic manufacturers;
    (3) The existence of substantial differentials between domestic 
prices and the higher of prices generally prevailing in foreign markets 
or the prices at which the applicant for registration to import is 
committed to undertake to provide such products in the domestic market 
in conformity with the Act. In determining the existence of substantial 
differentials hereunder, appropriate consideration should be given to 
any additional costs imposed on domestic manufacturers by the 
requirements of the Act and such other cost-related and other factors as 
the Administrator may deem relevant. In no event shall an importer's 
offering prices in the United States be considered if they are lower 
than those prevailing in the foreign market or markets from which the 
importer is obtaining his/her supply;
    (4) The existence of competitive restraints imposed upon domestic 
manufacturers by governmental regulations; and
    (5) Such other factors as may be relevant to the determinations 
required under this paragraph.
    (e) In considering the scope of the domestic market, consideration 
shall be given to substitute products which are reasonably 
interchangeable in terms of price, quality and use.
    (f) The fact that the number of existing manufacturers is small 
shall not demonstrate, in and of itself, that adequate competition among 
them does not exist.

[62 FR 13953, Mar. 24, 1997]



Sec. 1301.35  Certificate of registration; denial of registration.

    (a) The Administrator shall issue a Certificate of Registration (DEA 
Form 223) to an applicant if the issuance of registration or 
reregistration is required under the applicable provisions of sections 
303 or 1008 of the Act (21 U.S.C. 823 and 958). In the event that

[[Page 41]]

the issuance of registration or reregistration is not required, the 
Administrator shall deny the application. Before denying any 
application, the Administrator shall issue an order to show cause 
pursuant to Sec. 1301.37 and, if requested by the applicant, shall hold 
a hearing on the application pursuant to Sec. 1301.41.
    (b) If in response to a show cause order a hearing is requested by 
an applicant for registration or reregistration to manufacture in bulk a 
basic class of controlled substance listed in Schedule I or II, notice 
that a hearing has been requested shall be published in the Federal 
Register and shall be mailed simultaneously to the applicant and to all 
persons to whom notice of the application was mailed. Any person 
entitled to file comments or objections to the issuance of the proposed 
registration pursuant to Sec. 1301.33(a) may participate in the hearing 
by filing notice of appearance in accordance with Sec. 1301.43. Such 
persons shall have 30 days to file a notice of appearance after the date 
of publication of the notice of a request for a hearing in the Federal 
Register.
    (c) The Certificate of Registration (DEA Form 223) shall contain the 
name, address, and registration number of the registrant, the activity 
authorized by the registration, the schedules and/or Administration 
Controlled Substances Code Number (as set forth in part 1308 of this 
chapter) of the controlled substances which the registrant is authorized 
to handle, the amount of fee paid (or exemption), and the expiration 
date of the registration. The registrant shall maintain the certificate 
of registration at the registered location in a readily retrievable 
manner and shall permit inspection of the certificate by any official, 
agent or employee of the Administration or of any Federal, State, or 
local agency engaged in enforcement of laws relating to controlled 
substances.

[62 FR 13954, Mar. 24, 1997]



Sec. 1301.36  Suspension or revocation of registration; suspension of
registration pending final order; extension of registration pending 

final order.

    (a) For any registration issued under section 303 of the Act (21 
U.S.C. 823), the Administrator may:
    (1) Suspend the registration pursuant to section 304(a) of the Act 
(21 U.S.C. 824(a)) for any period of time.
    (2) Revoke the registration pursuant to section 304(a) of the Act 
(21 U.S.C. 824(a)).
    (b) For any registration issued under section 1008 of the Act (21 
U.S.C. 958), the Administrator may:
    (1) Suspend the registration pursuant to section 1008(d) of the Act 
(21 U.S.C. 958(d)) for any period of time.
    (2) Revoke the registration pursuant to section 1008(d) of the Act 
(21 U.S.C. 958(d)) if he/she determines that such registration is 
inconsistent with the public interest as defined in section 1008 or with 
the United States obligations under international treaties, conventions, 
or protocols in effect on October 12, 1984.
    (c) The Administrator may limit the revocation or suspension of a 
registration to the particular controlled substance, or substances, with 
respect to which grounds for revocation or suspension exist.
    (d) Before revoking or suspending any registration, the 
Administrator shall issue an order to show cause pursuant to Sec. 
1301.37 and, if requested by the registrant, shall hold a hearing 
pursuant to Sec. 1301.41.
    (e) The Administrator may suspend any registration simultaneously 
with or at any time subsequent to the service upon the registrant of an 
order to show cause why such registration should not be revoked or 
suspended, in any case where he/she finds that there is an imminent 
danger to the public health or safety. If the Administrator so suspends, 
he/she shall serve with the order to show cause pursuant to Sec. 
1301.37 an order of immediate suspension which shall contain a statement 
of his findings regarding the danger to public health or safety.
    (f) Upon service of the order of the Administrator suspending or 
revoking registration, the registrant shall immediately deliver his/her 
Certificate of

[[Page 42]]

Registration, any order forms, and any import or export permits in his/
her possession to the nearest office of the Administration. The 
suspension or revocation of a registration shall suspend or revoke any 
individual manufacturing or procurement quota fixed for the registrant 
pursuant to part 1303 of this chapter and any import or export permits 
issued to the registrant pursuant to part 1312 of this chapter. Also, 
upon service of the order of the Administrator revoking or suspending 
registration, the registrant shall, as instructed by the Administrator:
    (1) Deliver all controlled substances in his/her possession to the 
nearest office of the Administration or to authorized agents of the 
Administration; or
    (2) Place all controlled substances in his/her possession under seal 
as described in sections 304(f) or 1008(d)(6) of the Act (21 U.S.C. 
824(f) or 958(d)(6)).
    (g) In the event that revocation or suspension is limited to a 
particular controlled substance or substances, the registrant shall be 
given a new Certificate of Registration for all substances not affected 
by such revocation or suspension; no fee shall be required to be paid 
for the new Certificate of Registration. The registrant shall deliver 
the old Certificate of Registration and, if appropriate, any order forms 
in his/her possession to the nearest office of the Administration. The 
suspension or revocation of a registration, when limited to a particular 
basic class or classes of controlled substances, shall suspend or revoke 
any individual manufacturing or procurement quota fixed for the 
registrant for such class or classes pursuant to part 1303 of this 
chapter and any import or export permits issued to the registrant for 
such class or classes pursuant to part 1312 of this chapter. Also, upon 
service of the order of the Administrator revoking or suspending 
registration, the registrant shall, as instructed by the Administrator:
    (1) Deliver to the nearest office of the Administration or to 
authorized agents of the Administration all of the particular controlled 
substance or substances affected by the revocation or suspension which 
are in his/her possession; or
    (2) Place all of such substances under seal as described in sections 
304(f) or 958(d)(6) of the Act (21 U.S.C. 824(f) or 958(d)(6)).
    (h) Any suspension shall continue in effect until the conclusion of 
all proceedings upon the revocation or suspension, including any 
judicial review thereof, unless sooner withdrawn by the Administrator or 
dissolved by a court of competent jurisdiction. Any registrant whose 
registration is suspended under paragraph (e) of this section may 
request a hearing on the revocation or suspension of his/her 
registration at a time earlier than specified in the order to show cause 
pursuant to Sec. 1301.37. This request shall be granted by the 
Administrator, who shall fix a date for such hearing as early as 
reasonably possible.
    (i) In the event that an applicant for reregistration (who is doing 
business under a registration previously granted and not revoked or 
suspended) has applied for reregistration at least 45 days before the 
date on which the existing registration is due to expire, and the 
Administrator has issued no order on the application on the date on 
which the existing registration is due to expire, the existing 
registration of the applicant shall automatically be extended and 
continue in effect until the date on which the Administrator so issues 
his/her order. The Administrator may extend any other existing 
registration under the circumstances contemplated in this section even 
though the registrant failed to apply for reregistration at least 45 
days before expiration of the existing registration, with or without 
request by the registrant, if the Administrator finds that such 
extension is not inconsistent with the public health and safety.

[62 FR 13955, Mar. 24, 1997]



Sec. 1301.37  Order to show cause.

    (a) If, upon examination of the application for registration from 
any applicant and other information gathered by the Administration 
regarding the applicant, the Administrator is unable to make the 
determinations required by the applicable provisions of section 303 and/
or section 1008 of the Act (21 U.S.C. 823 and 958) to register the 
applicant, the Administrator shall serve

[[Page 43]]

upon the applicant an order to show cause why the registration should 
not be denied.
    (b) If, upon information gathered by the Administration regarding 
any registrant, the Administrator determines that the registration of 
such registrant is subject to suspension or revocation pursuant to 
section 304 or section 1008 of the Act (21 U.S.C. 824 and 958), the 
Administrator shall serve upon the registrant an order to show cause why 
the registration should not be revoked or suspended.
    (c) The order to show cause shall call upon the applicant or 
registrant to appear before the Administrator at a time and place stated 
in the order, which shall not be less than 30 days after the date of 
receipt of the order. The order to show cause shall also contain a 
statement of the legal basis for such hearing and for the denial, 
revocation, or suspension of registration and a summary of the matters 
of fact and law asserted.
    (d) Upon receipt of an order to show cause, the applicant or 
registrant must, if he/she desires a hearing, file a request for a 
hearing pursuant to Sec. 1301.43. If a hearing is requested, the 
Administrator shall hold a hearing at the time and place stated in the 
order, pursuant to Sec. 1301.41.
    (e) When authorized by the Administrator, any agent of the 
Administration may serve the order to show cause.

[62 FR 13955, Mar. 24, 1997]

                                Hearings



Sec. 1301.41  Hearings generally.

    (a) In any case where the Administrator shall hold a hearing on any 
registration or application therefor, the procedures for such hearing 
shall be governed generally by the adjudication procedures set forth in 
the Administrative Procedure Act (5 U.S.C. 551-559) and specifically by 
sections 303, 304, and 1008 of the Act (21 U.S.C. 823-824 and 958), by 
Sec. Sec. 1301.42-1301.46 of this part, and by the procedures for 
administrative hearings under the Act set forth in Sec. Sec. 1316.41-
1316.67 of this chapter.
    (b) Any hearing under this part shall be independent of, and not in 
lieu of, criminal prosecutions or other proceedings under the Act or any 
other law of the United States.

[62 FR 13956, Mar. 24, 1997]



Sec. 1301.42  Purpose of hearing.

    If requested by a person entitled to a hearing, the Administrator 
shall hold a hearing for the purpose of receiving factual evidence 
regarding the issues involved in the denial, revocation, or suspension 
of any registration, and the granting of any application for 
registration to import or to manufacture in bulk a basic class of 
controlled substance listed in Schedule I or II. Extensive argument 
should not be offered into evidence but rather presented in opening or 
closing statements of counsel or in memoranda or proposed findings of 
fact and conclusions of law.

[62 FR 13956, Mar. 24, 1997]



Sec. 1301.43  Request for hearing or appearance; waiver.

    (a) Any person entitled to a hearing pursuant to Sec. 1301.32 or 
Sec. Sec. 1301.34-1301.36 and desiring a hearing shall, within 30 days 
after the date of receipt of the order to show cause (or the date of 
publication of notice of the application for registration in the Federal 
Register in the case of Sec. 1301.34), file with the Administrator a 
written request for a hearing in the form prescribed in Sec. 1316.47 of 
this chapter.
    (b) Any person entitled to participate in a hearing pursuant to 
Sec. 1301.34 or Sec. 1301.35(b) and desiring to do so shall, within 30 
days of the date of publication of notice of the request for a hearing 
in the Federal Register, file with the Administrator a written notice of 
intent to participate in such hearing in the form prescribed in Sec. 
1316.48 of this chapter. Any person filing a request for a hearing need 
not also file a notice of appearance.
    (c) Any person entitled to a hearing or to participate in a hearing 
pursuant to Sec. 1301.32 or Sec. Sec. 1301.34-1301.36 may, within the 
period permitted for filing a request for a hearing or a notice of 
appearance, file with the Administrator a waiver of an opportunity for a 
hearing or to participate in a hearing, together with a written 
statement regarding such person's position on the matters

[[Page 44]]

of fact and law involved in such hearing. Such statement, if admissible, 
shall be made a part of the record and shall be considered in light of 
the lack of opportunity for cross-examination in determining the weight 
to be attached to matters of fact asserted therein.
    (d) If any person entitled to a hearing or to participate in a 
hearing pursuant to Sec. 1301.32 or Sec. Sec. 1301.34-1301.36 fails to 
file a request for a hearing or a notice of appearance, or if such 
person so files and fails to appear at the hearing, such person shall be 
deemed to have waived the opportunity for a hearing or to participate in 
the hearing, unless such person shows good cause for such failure.
    (e) If all persons entitled to a hearing or to participate in a 
hearing waive or are deemed to waive their opportunity for the hearing 
or to participate in the hearing, the Administrator may cancel the 
hearing, if scheduled, and issue his/her final order pursuant to Sec. 
1301.46 without a hearing.

[62 FR 13956, Mar. 24, 1997]



Sec. 1301.44  Burden of proof.

    (a) At any hearing on an application to manufacture any controlled 
substance listed in Schedule I or II, the applicant shall have the 
burden of proving that the requirements for such registration pursuant 
to section 303(a) of the Act (21 U.S.C. 823(a)) are satisfied. Any other 
person participating in the hearing pursuant to Sec. 1301.35(b) shall 
have the burden of proving any propositions of fact or law asserted by 
such person in the hearing.
    (b) At any hearing on the granting or denial of an applicant to be 
registered to conduct a narcotic treatment program or as a compounder, 
the applicant shall have the burden of proving that the requirements for 
each registration pursuant to section 303(g) of the Act (21 U.S.C. 
823(g)) are satisfied.
    (c) At any hearing on the granting or denial of an application to be 
registered to import or export any controlled substance listed in 
Schedule I or II, the applicant shall have the burden of proving that 
the requirements for such registration pursuant to sections 1008(a) and 
(d) of the Act (21 U.S.C. 958 (a) and (d)) are satisfied. Any other 
person participating in the hearing pursuant to Sec. 1301.34 shall have 
the burden of proving any propositions of fact or law asserted by him/
her in the hearings.
    (d) At any other hearing for the denial of a registration, the 
Administration shall have the burden of proving that the requirements 
for such registration pursuant to section 303 or section 1008(c) and (d) 
of the Act (21 U.S.C. 823 or 958(c) and (d)) are not satisfied.
    (e) At any hearing for the revocation or suspension of a 
registration, the Administration shall have the burden of proving that 
the requirements for such revocation or suspension pursuant to section 
304(a) or section 1008(d) of the Act (21 U.S.C. 824(a) or 958(d)) are 
satisfied.

[62 FR 13956, Mar. 24, 1997]



Sec. 1301.45  Time and place of hearing.

    The hearing will commence at the place and time designated in the 
order to show cause or notice of hearing published in the Federal 
Register (unless expedited pursuant to Sec. 1301.36(h)) but thereafter 
it may be moved to a different place and may be continued from day to 
day or recessed to a later day without notice other than announcement 
thereof by the presiding officer at the hearing.

[62 FR 13956, Mar. 24, 1997]



Sec. 1301.46  Final order.

    As soon as practicable after the presiding officer has certified the 
record to the Administrator, the Administrator shall issue his/her order 
on the granting, denial, revocation, or suspension of registration. In 
the event that an application for registration to import or to 
manufacture in bulk a basic class of any controlled substance listed in 
Schedule I or II is granted, or any application for registration is 
denied, or any registration is revoked or suspended, the order shall 
include the findings of fact and conclusions of law upon which the order 
is based. The order shall specify the date on which it shall take 
effect. The Administrator shall serve one copy of his/her order upon 
each party in the hearing.

[62 FR 13956, Mar. 24, 1997]

[[Page 45]]

         Modification, Transfer and Termination of Registration



Sec. 1301.51  Modification in registration.

    Any registrant may apply to modify his/her registration to authorize 
the handling of additional controlled substances or to change his/her 
name or address, by submitting a letter of request to the Registration 
Unit, Drug Enforcement Administration. See the Table of DEA Mailing 
Addresses in Sec. 1321.01 of this chapter for the current mailing 
address. The letter shall contain the registrant's name, address, and 
registration number as printed on the certificate of registration, and 
the substances and/or schedules to be added to his/her registration or 
the new name or address and shall be signed in accordance with Sec. 
1301.13(j). If the registrant is seeking to handle additional controlled 
substances listed in Schedule I for the purpose of research or 
instructional activities, he/she shall attach three copies of a research 
protocol describing each research project involving the additional 
substances, or two copies of a statement describing the nature, extent, 
and duration of such instructional activities, as appropriate. No fee 
shall be required to be paid for the modification. The request for 
modification shall be handled in the same manner as an application for 
registration. If the modification in registration is approved, the 
Administrator shall issue a new certificate of registration (DEA Form 
223) to the registrant, who shall maintain it with the old certificate 
of registration until expiration.

[75 FR 10676, Mar. 9, 2010]



Sec. 1301.52  Termination of registration; transfer of registration;
distribution upon discontinuance of business.

    (a) Except as provided in paragraph (b) of this section, the 
registration of any person, and any modifications of that registration, 
shall terminate, without any further action by the Administration, if 
and when such person dies, ceases legal existence, discontinues business 
or professional practice, or surrenders a registration. Any registrant 
who ceases legal existence or discontinues business or professional 
practice shall notify the Administrator promptly of such fact. In the 
case of a surrender, termination shall occur upon receipt by any 
employee of the Administration of a duly executed DEA form 104 or any 
signed writing indicating the desire to surrender a registration.
    (b) No registration or any authority conferred thereby shall be 
assigned or otherwise transferred except upon such conditions as the 
Administration may specifically designate and then only pursuant to 
written consent. Any person seeking authority to transfer a registration 
shall submit a written request, providing full details regarding the 
proposed transfer of registration, to the Deputy Assistant 
Administrator, Office of Diversion Control, Drug Enforcement 
Administration. See the Table of DEA Mailing Addresses in Sec. 1321.01 
of this chapter for the current mailing address.
    (c) Any registrant desiring to discontinue business activities 
altogether or with respect to controlled substances (without 
transferring such business activities to another person) shall return 
for cancellation his/her certificate of registration, and any unexecuted 
order forms in his/her possession, to the Registration Unit, Drug 
Enforcement Administration. See the Table of DEA Mailing Addresses in 
Sec. 1321.01 of this chapter for the current mailing address. Any 
controlled substances in his/her possession may be disposed of in 
accordance with Sec. 1307.21 of this chapter.
    (d) Any registrant desiring to discontinue business activities 
altogether or with respect to controlled substance (by transferring such 
business activities to another person) shall submit in person or by 
registered or certified mail, return receipt requested, to the Special 
Agent in Charge in his/her area, at least 14 days in advance of the date 
of the proposed transfer (unless the Special Agent in Charge waives this 
time limitation in individual instances), the following information:
    (1) The name, address, registration number, and authorized business 
activity of the registrant discontinuing the business (registrant-
transferor);

[[Page 46]]

    (2) The name, address, registration number, and authorized business 
activity of the person acquiring the business (registrant-transferee);
    (3) Whether the business activities will be continued at the 
location registered by the person discontinuing business, or moved to 
another location (if the latter, the address of the new location should 
be listed);
    (4) Whether the registrant-transferor has a quota to manufacture or 
procure any controlled substance listed in Schedule I or II (if so, the 
basic class or class of the substance should be indicated); and
    (5) The date on which the transfer of controlled substances will 
occur.
    (e) Unless the registrant-transferor is informed by the Special 
Agent in Charge, before the date on which the transfer was stated to 
occur, that the transfer may not occur, the registrant-transferor may 
distribute (without being registered to distribute) controlled 
substances in his/her possession to the registrant-transferee in 
accordance with the following:
    (1) On the date of transfer of the controlled substances, a complete 
inventory of all controlled substances being transferred shall be taken 
in accordance with Sec. 1304.11 of this chapter. This inventory shall 
serve as the final inventory of the registrant-transferor and the 
initial inventory of the registrant-transferee, and a copy of the 
inventory shall be included in the records of each person. It shall not 
be necessary to file a copy of the inventory with the Administration 
unless requested by the Special Agent in Charge. Transfers of any 
substances listed in Schedule I or II shall require the use of order 
forms in accordance with part 1305 of this chapter.
    (2) On the date of transfer of the controlled substances, all 
records required to be kept by the registrant-transferor with reference 
to the controlled substances being transferred, under part 1304 of this 
chapter, shall be transferred to the registrant-transferee. 
Responsibility for the accuracy of records prior to the date of transfer 
remains with the transferor, but responsibility for custody and 
maintenance shall be upon the transferee.
    (3) In the case of registrants required to make reports pursuant to 
part 1304 of this chapter, a report marked ``Final'' will be prepared 
and submitted by the registrant-transferor showing the disposition of 
all the controlled substances for which a report is required; no 
additional report will be required from him, if no further transactions 
involving controlled substances are consummated by him. The initial 
report of the registrant-transferee shall account for transactions 
beginning with the day next succeeding the date of discontinuance or 
transfer of business by the transferor-registrant and the substances 
transferred to him shall be reported as receipts in his/her initial 
report.

[62 FR 13957, Mar. 24, 1997, as amended at 74 FR 15623, Apr. 6, 2009; 75 
FR 10676, Mar. 9, 2010; 76 FR 61564, Oct. 5, 2011]

                          Security Requirements



Sec. 1301.71  Security requirements generally.

    (a) All applicants and registrants shall provide effective controls 
and procedures to guard against theft and diversion of controlled 
substances. In order to determine whether a registrant has provided 
effective controls against diversion, the Administrator shall use the 
security requirements set forth in Sec. Sec. 1301.72-1301.76 as 
standards for the physical security controls and operating procedures 
necessary to prevent diversion. Materials and construction which will 
provide a structural equivalent to the physical security controls set 
forth in Sec. Sec. 1301.72, 1301.73 and 1301.75 may be used in lieu of 
the materials and construction described in those sections.
    (b) Substantial compliance with the standards set forth in 
Sec. Sec. 1301.72-1301.76 may be deemed sufficient by the Administrator 
after evaluation of the overall security system and needs of the 
applicant or registrant. In evaluating the overall security system of a 
registrant or applicant, the Administrator may consider any of the 
following factors as he may deem relevant to the need for strict 
compliance with security requirements:

[[Page 47]]

    (1) The type of activity conducted (e.g., processing of bulk 
chemicals, preparing dosage forms, packaging, labeling, cooperative 
buying, etc.);
    (2) The type and form of controlled substances handled (e.g., bulk 
liquids or dosage units, usable powders or nonusable powders);
    (3) The quantity of controlled substances handled;
    (4) The location of the premises and the relationship such location 
bears on security needs;
    (5) The type of building construction comprising the facility and 
the general characteristics of the building or buildings;
    (6) The type of vault, safe, and secure enclosures or other storage 
system (e.g., automatic storage and retrieval system) used;
    (7) The type of closures on vaults, safes, and secure enclosures;
    (8) The adequacy of key control systems and/or combination lock 
control systems;
    (9) The adequacy of electric detection and alarm systems, if any 
including use of supervised transmittal lines and standby power sources;
    (10) The extent of unsupervised public access to the facility, 
including the presence and characteristics of perimeter fencing, if any;
    (11) The adequacy of supervision over employees having access to 
manufacturing and storage areas;
    (12) The procedures for handling business guests, visitors, 
maintenance personnel, and nonemployee service personnel;
    (13) The availability of local police protection or of the 
registrant's or applicant's security personnel;
    (14) The adequacy of the registrant's or applicant's system for 
monitoring the receipt, manufacture, distribution, and disposition of 
controlled substances in its operations; and
    (15) The applicability of the security requirements contained in all 
Federal, State, and local laws and regulations governing the management 
of waste.
    (c) When physical security controls become inadequate as a result of 
a controlled substance being transferred to a different schedule, or as 
a result of a noncontrolled substance being listed on any schedule, or 
as a result of a significant increase in the quantity of controlled 
substances in the possession of the registrant during normal business 
operations, the physical security controls shall be expanded and 
extended accordingly. A registrant may adjust physical security controls 
within the requirements set forth in Sec. Sec. 1301.72-1301.76 when the 
need for such controls decreases as a result of a controlled substance 
being transferred to a different schedule, or a result of a controlled 
substance being removed from control, or as a result of a significant 
decrease in the quantity of controlled substances in the possession of 
the registrant during normal business operations.
    (d) Any registrant or applicant desiring to determine whether a 
proposed security system substantially complies with, or is the 
structural equivalent of, the requirements set forth in Sec. Sec. 
1301.72-1301.76 may submit any plans, blueprints, sketches or other 
materials regarding the proposed security system either to the Special 
Agent in Charge in the region in which the system will be used, or to 
the Regulatory Section, Drug Enforcement Administration. See the Table 
of DEA Mailing Addresses in Sec. 1321.01 of this chapter for the 
current mailing address.
    (e) Physical security controls of locations registered under the 
Harrison Narcotic Act or the Narcotics Manufacturing Act of 1960 on 
April 30, 1971, shall be deemed to comply substantially with the 
standards set forth in Sec. Sec. 1301.72, 1301.73 and 1301.75. Any new 
facilities or work or storage areas constructed or utilized for 
controlled substances, which facilities or work or storage areas have 
not been previously approved by the Administration, shall not 
necessarily be deemed to comply substantially with the standards set 
forth in Sec. Sec. 1301.72, 1301.73 and 1301.75, notwithstanding that 
such facilities or work or storage areas have physical security controls 
similar to those previously approved by the Administration.

[36 FR 18729, Sept. 21, 1971. Redesignated at 38 FR 26609, Sept. 24, 
1973, and amended at 46 FR 28841, May 29, 1981; 47 FR 41735, Sept. 22, 
1982; 51 FR 5319, Feb. 13, 1986; 68 FR 41228, July 11, 2003; 75 FR 
10677, Mar. 9, 2010]

[[Page 48]]



Sec. 1301.72  Physical security controls for non-practitioners;
narcotic treatment programs and compounders for narcotic treatment

programs; storage areas.

    (a) Schedules I and II. Raw material, bulk materials awaiting 
further processing, and finished products which are controlled 
substances listed in Schedule I or II (except GHB that is manufactured 
or distributed in accordance with an exemption under section 505(i) of 
the FFDCA which shall be subject to the requirements of paragraph (b) of 
this section) shall be stored in one of the following secured areas:
    (1) Where small quantities permit, a safe or steel cabinet;
    (i) Which safe or steel cabinet shall have the following 
specifications or the equivalent: 30 man-minutes against surreptitious 
entry, 10 man-minutes against forced entry, 20 man-hours against lock 
manipulation, and 20 man-hours against radiological techniques;
    (ii) Which safe or steel cabinet, if it weighs less than 750 pounds, 
is bolted or cemented to the floor or wall in such a way that it cannot 
be readily removed; and
    (iii) Which safe or steel cabinet, if necessary, depending upon the 
quantities and type of controlled substances stored, is equipped with an 
alarm system which, upon attempted unauthorized entry, shall transmit a 
signal directly to a central protection company or a local or State 
police agency which has a legal duty to respond, or a 24-hour control 
station operated by the registrant, or such other protection as the 
Administrator may approve.
    (2) A vault constructed before, or under construction on, September 
1, 1971, which is of substantial construction with a steel door, 
combination or key lock, and an alarm system; or
    (3) A vault constructed after September 1, 1971:
    (i) The walls, floors, and ceilings of which vault are constructed 
of at least 8 inches of reinforced concrete or other substantial 
masonry, reinforced vertically and horizontally with \1/2\-inch steel 
rods tied 6 inches on center, or the structural equivalent to such 
reinforced walls, floors, and ceilings;
    (ii) The door and frame unit of which vault shall conform to the 
following specifications or the equivalent: 30 man-minutes against 
surreptitious entry, 10 man-minutes against forced entry, 20 man-hours 
against lock manipulation, and 20 man-hours against radiological 
techniques;
    (iii) Which vault, if operations require it to remain open for 
frequent access, is equipped with a ``day-gate'' which is self-closing 
and self-locking, or the equivalent, for use during the hours of 
operation in which the vault door is open;
    (iv) The walls or perimeter of which vault are equipped with an 
alarm, which upon unauthorized entry shall transmit a signal directly to 
a central station protection company, or a local or State police agency 
which has a legal duty to respond, or a 24-hour control station operated 
by the registrant, or such other protection as the Administrator may 
approve, and, if necessary, holdup buttons at strategic points of entry 
to the perimeter area of the vault;
    (v) The door of which vault is equipped with contact switches; and
    (vi) Which vault has one of the following: Complete electrical 
lacing of the walls, floor and ceilings; sensitive ultrasonic equipment 
within the vault; a sensitive sound accumulator system; or such other 
device designed to detect illegal entry as may be approved by the 
Administration.
    (b) Schedules III, IV and V. Raw material, bulk materials awaiting 
further processing, and finished products which are controlled 
substances listed in Schedules III, IV, and V, and GHB when it is 
manufactured or distributed in accordance with an exemption under 
section 505(i) of the FFDCA, shall be stored in the following secure 
storage areas:
    (1) A safe or steel cabinet as described in paragraph (a)(1) of this 
section;
    (2) A vault as described in paragraph (a)(2) or (3) of this section 
equipped with an alarm system as described in paragraph (b)(4)(v) of 
this section;
    (3) A building used for storage of Schedules III through V 
controlled substances with perimeter security which limits access during 
working hours and provides security after working hours and meets the 
following specifications:

[[Page 49]]

    (i) Has an electronic alarm system as described in paragraph 
(b)(4)(v) of this section,
    (ii) Is equipped with self-closing, self-locking doors constructed 
of substantial material commensurate with the type of building 
construction, provided, however, a door which is kept closed and locked 
at all times when not in use and when in use is kept under direct 
observation of a responsible employee or agent of the registrant is 
permitted in lieu of a self-closing, self-locking door. Doors may be 
sliding or hinged. Regarding hinged doors, where hinges are mounted on 
the outside, such hinges shall be sealed, welded or otherwise 
constructed to inhibit removal. Locking devices for such doors shall be 
either of the multiple-position combination or key lock type and:
    (a) In the case of key locks, shall require key control which limits 
access to a limited number of employees, or;
    (b) In the case of combination locks, the combination shall be 
limited to a minimum number of employees and can be changed upon 
termination of employment of an employee having knowledge of the 
combination;
    (4) A cage, located within a building on the premises, meeting the 
following specifications:
    (i) Having walls constructed of not less than No. 10 gauge steel 
fabric mounted on steel posts, which posts are:
    (a) At least one inch in diameter;
    (b) Set in concrete or installed with lag bolts that are pinned or 
brazed; and
    (c) Which are placed no more than ten feet apart with horizontal one 
and one-half inch reinforcements every sixty inches;
    (ii) Having a mesh construction with openings of not more than two 
and one-half inches across the square,
    (iii) Having a ceiling constructed of the same material, or in the 
alternative, a cage shall be erected which reaches and is securely 
attached to the structural ceiling of the building. A lighter gauge mesh 
may be used for the ceilings of large enclosed areas if walls are at 
least 14 feet in height,
    (iv) Is equipped with a door constructed of No. 10 gauge steel 
fabric on a metal door frame in a metal door flange, and in all other 
respects conforms to all the requirements of 21 CFR 1301.72(b)(3)(ii), 
and
    (v) Is equipped with an alarm system which upon unauthorized entry 
shall transmit a signal directly to a central station protection agency 
or a local or state police agency, each having a legal duty to respond, 
or to a 24-hour control station operated by the registrant, or to such 
other source of protection as the Administrator may approve;
    (5) An enclosure of masonry or other material, approved in writing 
by the Administrator as providing security comparable to a cage;
    (6) A building or enclosure within a building which has been 
inspected and approved by DEA or its predecessor agency, BND, and 
continues to provide adequate security against the diversion of Schedule 
III through V controlled substances, of which fact written 
acknowledgment has been made by the Special Agent in Charge of DEA for 
the area in which such building or enclosure is situated;
    (7) Such other secure storage areas as may be approved by the 
Administrator after considering the factors listed in Sec. 1301.71(b);
    (8)(i) Schedule III through V controlled substances may be stored 
with Schedules I and II controlled substances under security measures 
provided by 21 CFR 1301.72(a);
    (ii) Non-controlled drugs, substances and other materials may be 
stored with Schedule III through V controlled substances in any of the 
secure storage areas required by 21 CFR 1301.72(b), provided that 
permission for such storage of non-controlled items is obtained in 
advance, in writing, from the Special Agent in Charge of DEA for the 
area in which such storage area is situated. Any such permission 
tendered must be upon the Special Agent in Charge's written 
determination that such non-segregated storage does not diminish 
security effectiveness for Schedules III through V controlled 
substances.
    (c) Multiple storage areas. Where several types or classes of 
controlled substances are handled separately by the registrant or 
applicant for different purposes (e.g., returned goods, or goods in 
process), the controlled substances

[[Page 50]]

may be stored separately, provided that each storage area complies with 
the requirements set forth in this section.
    (d) Accessibility to storage areas. The controlled substances 
storage areas shall be accessible only to an absolute minimum number of 
specifically authorized employees. When it is necessary for employee 
maintenance personnel, nonemployee maintenance personnel, business 
guests, or visitors to be present in or pass through controlled 
substances storage areas, the registrant shall provide for adequate 
observation of the area by an employee specifically authorized in 
writing.

[36 FR 18730, Sept. 21, 1971. Redesignated at 38 FR 26609, Sept. 24, 
1973]

    Editorial Note: For Federal Register citations affecting Sec. 
1301.72, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and at www.fdsys.gov.



Sec. 1301.73  Physical security controls for non-practitioners; 
compounders for narcotic treatment programs; manufacturing and 

compounding areas.

    All manufacturing activities (including processing, packaging and 
labeling) involving controlled substances listed in any schedule and all 
activities of compounders shall be conducted in accordance with the 
following:
    (a) All in-process substances shall be returned to the controlled 
substances storage area at the termination of the process. If the 
process is not terminated at the end of a workday (except where a 
continuous process or other normal manufacturing operation should not be 
interrupted), the processing area or tanks, vessels, bins or bulk 
containers containing such substances shall be securely locked, with 
adequate security for the area or building. If such security requires an 
alarm, such alarm, upon unauthorized entry, shall transmit a signal 
directly to a central station protection company, or local or state 
police agency which has a legal duty to respond, or a 24-hour control 
station operated by the registrant.
    (b) Manufacturing activities with controlled substances shall be 
conducted in an area or areas of clearly defined limited access which is 
under surveillance by an employee or employees designated in writing as 
responsible for the area. ``Limited access'' may be provided, in the 
absence of physical dividers such as walls or partitions, by traffic 
control lines or restricted space designation. The employee designated 
as responsible for the area may be engaged in the particular 
manufacturing operation being conducted: Provided, That he is able to 
provide continuous surveillance of the area in order that unauthorized 
persons may not enter or leave the area without his knowledge.
    (c) During the production of controlled substances, the 
manufacturing areas shall be accessible to only those employees required 
for efficient operation. When it is necessary for employee maintenance 
personnel, nonemployee maintenance personnel, business guests, or 
visitors to be present in or pass through manufacturing areas during 
production of controlled substances, the registrant shall provide for 
adequate observation of the area by an employee specifically authorized 
in writing.

[36 FR 18731, Sept. 21, 1971. Redesignated at 38 FR 26609, Sept. 24, 
1973 and amended at 39 FR 37984, Oct. 25, 1974]



Sec. 1301.74  Other security controls for non-practitioners; narcotic 
treatment programs and compounders for narcotic treatment programs.

    (a) Before distributing a controlled substance to any person who the 
registrant does not know to be registered to possess the controlled 
substance, the registrant shall make a good faith inquiry either with 
the Administration or with the appropriate State controlled substances 
registration agency, if any, to determine that the person is registered 
to possess the controlled substance.
    (b) The registrant shall design and operate a system to disclose to 
the registrant suspicious orders of controlled substances. The 
registrant shall inform the Field Division Office of the Administration 
in his area of suspicious orders when discovered by the registrant. 
Suspicious orders include orders of unusual size, orders deviating 
substantially from a normal pattern, and orders of unusual frequency.

[[Page 51]]

    (c) The registrant shall notify the Field Division Office of the 
Administration in his area, in writing, of any theft or significant loss 
of any controlled substances within one business day of discovery of the 
theft or loss. The supplier is responsible for reporting all in-transit 
losses of controlled substances by the common or contract carrier 
selected pursuant to paragraph (e) of this section, within one business 
day of discovery of such theft or loss. The registrant shall also 
complete, and submit to the Field Division Office in his area, DEA Form 
106 regarding the theft or loss. Thefts and significant losses must be 
reported whether or not the controlled substances are subsequently 
recovered or the responsible parties are identified and action taken 
against them. When determining whether a loss is significant, a 
registrant should consider, among others, the following factors:
    (1) The actual quantity of controlled substances lost in relation to 
the type of business;
    (2) The specific controlled substances lost;
    (3) Whether the loss of the controlled substances can be associated 
with access to those controlled substances by specific individuals, or 
whether the loss can be attributed to unique activities that may take 
place involving the controlled substances;
    (4) A pattern of losses over a specific time period, whether the 
losses appear to be random, and the results of efforts taken to resolve 
the losses; and, if known,
    (5) Whether the specific controlled substances are likely candidates 
for diversion;
    (6) Local trends and other indicators of the diversion potential of 
the missing controlled substance.
    (d) The registrant shall not distribute any controlled substance 
listed in Schedules II through V as a complimentary sample to any 
potential or current customer (1) without the prior written request of 
the customer, (2) to be used only for satisfying the legitimate medical 
needs of patients of the customer, and (3) only in reasonable 
quantities. Such request must contain the name, address, and 
registration number of the customer and the name and quantity of the 
specific controlled substance desired. The request shall be preserved by 
the registrant with other records of distribution of controlled 
substances. In addition, the requirements of part 1305 of the chapter 
shall be complied with for any distribution of a controlled substance 
listed in Schedule II. For purposes of this paragraph, the term 
``customer'' includes a person to whom a complimentary sample of a 
substance is given in order to encourage the prescribing or recommending 
of the substance by the person.
    (e) When shipping controlled substances, a registrant is responsible 
for selecting common or contract carriers which provide adequate 
security to guard against in-transit losses. When storing controlled 
substances in a public warehouse, a registrant is responsible for 
selecting a warehouseman which will provide adequate security to guard 
against storage losses; wherever possible, the registrant shall store 
controlled substances in a public warehouse which complies with the 
requirements set forth in Sec. 1301.72. In addition, the registrant 
shall employ precautions (e.g., assuring that shipping containers do not 
indicate that contents are controlled substances) to guard against 
storage or in-transit losses.
    (f) When distributing controlled substances through agents (e.g., 
detailmen), a registrant is responsible for providing and requiring 
adequate security to guard against theft and diversion while the 
substances are being stored or handled by the agent or agents.
    (g) Before the initial distribution of carfentanil etorphine 
hydrochloride and/or diprenorphine to any person, the registrant must 
verify that the person is authorized to handle the substances(s) by 
contacting the Drug Enforcement Administration.
    (h) The acceptance of delivery of narcotic substances by a narcotic 
treatment program shall be made only by a licensed practitioner employed 
at the facility or other authorized individuals designated in writing. 
At the time of delivery, the licensed practitioner or other authorized 
individual designated in writing (excluding persons currently

[[Page 52]]

or previously dependent on narcotic drugs), shall sign for the narcotics 
and place his specific title (if any) on any invoice. Copies of these 
signed invoices shall be kept by the distributor.
    (i) Narcotics dispensed or administered at a narcotic treatment 
program will be dispensed or administered directly to the patient by 
either (1) the licensed practitioner, (2) a registered nurse under the 
direction of the licensed practitioner, (3) a licensed practical nurse 
under the direction of the licensed practitioner, or (4) a pharmacist 
under the direction of the licensed practitioner.
    (j) Persons enrolled in a narcotic treatment program will be 
required to wait in an area physically separated from the narcotic 
storage and dispensing area. This requirement will be enforced by the 
program physician and employees.
    (k) All narcotic treatment programs must comply with standards 
established by the Secretary of Health and Human Services (after 
consultation with the Administration) respecting the quantities of 
narcotic drugs which may be provided to persons enrolled in a narcotic 
treatment program for unsupervised use.
    (l) DEA may exercise discretion regarding the degree of security 
required in narcotic treatment programs based on such factors as the 
location of a program, the number of patients enrolled in a program and 
the number of physicians, staff members and security guards. Similarly, 
such factors will be taken into consideration when evaluating existing 
security or requiring new security at a narcotic treatment program.

[36 FR 7778, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973]

    Editorial Note: For Federal Register citations affecting Sec. 
1301.74, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and at www.fdsys.gov.



Sec. 1301.75  Physical security controls for practitioners.

    (a) Controlled substances listed in Schedule I shall be stored in a 
securely locked, substantially constructed cabinet.
    (b) Controlled substances listed in Schedules II, III, IV, and V 
shall be stored in a securely locked, substantially constructed cabinet. 
However, pharmacies and institutional practitioners may disperse such 
substances throughout the stock of noncontrolled substances in such a 
manner as to obstruct the theft or diversion of the controlled 
substances.
    (c) This section shall also apply to nonpractitioners authorized to 
conduct research or chemical analysis under another registration.
    (d) Carfentanil etorphine hydrochloride and diprenorphine shall be 
stored in a safe or steel cabinet equivalent to a U.S. Government Class 
V security container.

[39 FR 3674, Jan. 29, 1974, as amended at 39 FR 17838, May 21, 1974; 54 
FR 33674, Aug. 16, 1989; 62 FR 13957, Mar. 24, 1997]



Sec. 1301.76  Other security controls for practitioners.

    (a) The registrant shall not employ, as an agent or employee who has 
access to controlled substances, any person who has been convicted of a 
felony offense relating to controlled substances or who, at any time, 
had an application for registration with the DEA denied, had a DEA 
registration revoked or has surrendered a DEA registration for cause. 
For purposes of this subsection, the term ``for cause'' means a 
surrender in lieu of, or as a consequence of, any federal or state 
administrative, civil or criminal action resulting from an investigation 
of the individual's handling of controlled substances.
    (b) The registrant shall notify the Field Division Office of the 
Administration in his area, in writing, of the theft or significant loss 
of any controlled substances within one business day of discovery of 
such loss or theft. The registrant shall also complete, and submit to 
the Field Division Office in his area, DEA Form 106 regarding the loss 
or theft. When determining whether a loss is significant, a registrant 
should consider, among others, the following factors:
    (1) The actual quantity of controlled substances lost in relation to 
the type of business;
    (2) The specific controlled substances lost;

[[Page 53]]

    (3) Whether the loss of the controlled substances can be associated 
with access to those controlled substances by specific individuals, or 
whether the loss can be attributed to unique activities that may take 
place involving the controlled substances;
    (4) A pattern of losses over a specific time period, whether the 
losses appear to be random, and the results of efforts taken to resolve 
the losses; and, if known,
    (5) Whether the specific controlled substances are likely candidates 
for diversion;
    (6) Local trends and other indicators of the diversion potential of 
the missing controlled substance.
    (c) Whenever the registrant distributes a controlled substance 
(without being registered as a distributor, as permitted in Sec. 
1301.13(e)(1) and/or Sec. Sec. 1307.11-1307.12) he/she shall comply 
with the requirements imposed on nonpractitioners in Sec. 1301.74 (a), 
(b), and (e).
    (d) Central fill pharmacies must comply with Sec. 1301.74(e) when 
selecting private, common or contract carriers to transport filled 
prescriptions to a retail pharmacy for delivery to the ultimate user. 
When central fill pharmacies contract with private, common or contract 
carriers to transport filled prescriptions to a retail pharmacy, the 
central fill pharmacy is responsible for reporting in-transit losses 
upon discovery of such loss by use of a DEA Form 106. Retail pharmacies 
must comply with Sec. 1301.74(e) when selecting private, common or 
contract carriers to retrieve filled prescriptions from a central fill 
pharmacy. When retail pharmacies contract with private, common or 
contract carriers to retrieve filled prescriptions from a central fill 
pharmacy, the retail pharmacy is responsible for reporting in-transit 
losses upon discovery of such loss by use of a DEA Form 106.

[36 FR 7778, Apr. 24, 1971, as amended at 36 FR 18731, Sept. 21, 1971; 
37 FR 15919, Aug. 8, 1972. Redesignated at 38 FR 26609, Sept. 24, 1973; 
47 FR 41735, Sept. 22, 1982; 56 FR 36728, Aug. 1, 1991; 62 FR 13957, 
Mar. 24, 1997; 68 FR 37409, June 24, 2003; 70 FR 47097, Aug. 12, 2005]



Sec. 1301.77  Security controls for freight forwarding facilities.

    (a) All Schedule II-V controlled substances that will be temporarily 
stored at the freight forwarding facility must be either:
    (1) stored in a segregated area under constant observation by 
designated responsible individual(s); or
    (2) stored in a secured area that meets the requirements of Section 
1301.72(b) of this Part. For purposes of this requirement, a facility 
that may be locked down (i.e., secured against physical entry in a 
manner consistent with requirements of Section 1301.72(b)(3)(ii) of this 
part) and has a monitored alarm system or is subject to continuous 
monitoring by security personnel will be deemed to meet the requirements 
of Section 1301.72(b)(3) of this Part.
    (b) Access to controlled substances must be kept to an absolute 
minimum number of specifically authorized individuals. Non-authorized 
individuals may not be present in or pass through controlled substances 
storage areas without adequate observation provided by an individual 
authorized in writing by the registrant.
    (c) Controlled substances being transferred through a freight 
forwarding facility must be packed in sealed, unmarked shipping 
containers.

[65 FR 44678, July 19, 2000; 65 FR 45829, July 25, 2000]

                  Employee Screening--Non-Practitioners



Sec. 1301.90  Employee screening procedures.

    It is the position of DEA that the obtaining of certain information 
by non-practitioners is vital to fairly assess the likelihood of an 
employee committing a drug security breach. The need to know this 
information is a matter of business necessity, essential to overall 
controlled substances security. In this regard, it is believed that 
conviction of crimes and unauthorized use of controlled substances are 
activities that are proper subjects for inquiry. It is, therefore, 
assumed that the following questions will become a part of an employer's 
comprehensive employee screening program:


[[Page 54]]


    Question. Within the past five years, have you been convicted of a 
felony, or within the past two years, of any misdemeanor or are you 
presently formally charged with committing a criminal offense? (Do not 
include any traffic violations, juvenile offenses or military 
convictions, except by general court-martial.) If the answer is yes, 
furnish details of conviction, offense, location, date and sentence.

    Question. In the past three years, have you ever knowingly used any 
narcotics, amphetamines or barbiturates, other than those prescribed to 
you by a physician? If the answer is yes, furnish details.

    Advice. An authorization, in writing, that allows inquiries to be 
made of courts and law enforcement agencies for possible pending charges 
or convictions must be executed by a person who is allowed to work in an 
area where access to controlled substances clearly exists. A person must 
be advised that any false information or omission of information will 
jeopardize his or her position with respect to employment. The 
application for employment should inform a person that information 
furnished or recovered as a result of any inquiry will not necessarily 
preclude employment, but will be considered as part of an overall 
evaluation of the person's qualifications. The maintaining of fair 
employment practices, the protection of the person's right of privacy, 
and the assurance that the results of such inquiries will be treated by 
the employer in confidence will be explained to the employee.

[40 FR 17143, Apr. 17, 1975]



Sec. 1301.91  Employee responsibility to report drug diversion.

    Reports of drug diversion by fellow employees is not only a 
necessary part of an overall employee security program but also serves 
the public interest at large. It is, therefore, the position of DEA that 
an employee who has knowledge of drug diversion from his employer by a 
fellow employee has an obligation to report such information to a 
responsible security official of the employer. The employer shall treat 
such information as confidential and shall take all reasonable steps to 
protect the confidentiality of the information and the identity of the 
employee furnishing information. A failure to report information of drug 
diversion will be considered in determining the feasibility of 
continuing to allow an employee to work in a drug security area. The 
employer shall inform all employees concerning this policy.

[40 FR 17143, Apr. 17, 1975]



Sec. 1301.92  Illicit activities by employees.

    It is the position of DEA that employees who possess, sell, use or 
divert controlled substances will subject themselves not only to State 
or Federal prosecution for any illicit activity, but shall also 
immediately become the subject of independent action regarding their 
continued employment. The employer will assess the seriousness of the 
employee's violation, the position of responsibility held by the 
employee, past record of employment, etc., in determining whether to 
suspend, transfer, terminate or take other action against the employee.

[40 FR 17143, Apr. 17, 1975]



Sec. 1301.93  Sources of information for employee checks.

    DEA recommends that inquiries concerning employees' criminal records 
be made as follows:

    Local inquiries. Inquiries should be made by name, date and place of 
birth, and other identifying information, to local courts and law 
enforcement agencies for records of pending charges and convictions. 
Local practice may require such inquiries to be made in person, rather 
than by mail, and a copy of an authorization from the employee may be 
required by certain law enforcement agencies.
    DEA inquiries. Inquiries supplying identifying information should 
also be furnished to DEA Field Division Offices along with written 
consent from the concerned individual for a check of DEA files for 
records of convictions. The Regional check will result in a national 
check being made by the Field Division Office.

[40 FR 17143, Apr. 17, 1975, as amended at 47 FR 41735, Sept. 22, 1982]



PART 1302_LABELING AND PACKAGING REQUIREMENTS FOR CONTROLLED 
SUBSTANCES--Table of Contents



Sec.
1302.01 Scope of part 1302.
1302.02 Definitions.
1302.03 Symbol required; exceptions.
1302.04 Location and size of symbol on label and labeling.
1302.05 Effective dates of labeling requirements.

[[Page 55]]

1302.06 Sealing of controlled substances.
1302.07 Labeling and packaging requirements for imported and exported 
          substances.

    Authority: 21 U.S.C. 821, 825, 871(b), 958(e).

    Source: 36 FR 7785, Apr. 24, 1971, unless otherwise noted. 
Redesignated at 38 FR 26609, Sept. 24, 1973.



Sec. 1302.01  Scope of part 1302.

    Requirements governing the labeling and packaging of controlled 
substances pursuant to sections 1305 and 1008(d) of the Act (21 U.S.C. 
825 and 958(d)) are set forth generally by those sections and 
specifically by the sections of this part.

[36 FR 13386, July 21, 1971. Redesignated at 38 FR 26609, Sept. 24, 
1973]



Sec. 1302.02  Definitions.

    Any term contained in this part shall have the definition set forth 
in section 102 of the Act (21 U.S.C. 802) or part 1300 of this chapter.

[62 FR 13958, Mar. 24, 1997]



Sec. 1302.03  Symbol required; exceptions.

    (a) Each commercial container of a controlled substance (except for 
a controlled substance excepted by the Administrator pursuant to Sec. 
1308.31 of this chapter) shall have printed on the label the symbol 
designating the schedule in which such controlled substance is listed. 
Each such commercial container, if it otherwise has no label, must bear 
a label complying with the requirement of this part.
    (b) Each manufacturer shall print upon the labeling of each 
controlled substance distributed by him the symbol designating the 
schedule in which such controlled substance is listed.
    (c) The following symbols shall designate the schedule corresponding 
thereto:

 
                 Schedule
 
Schedule I................................  CI or C-I.
Schedule II...............................  CII or C-II.
Schedule III..............................  CIII or C-III.
Schedule IV...............................  CIV or C-IV.
Schedule V................................  CV or C-V.
 


The word ``schedule'' need not be used. No distinction need be made 
between narcotic and nonnarcotic substances.
    (d) The symbol is not required on a carton or wrapper in which a 
commercial container is held if the symbol is easily legible through 
such carton or wrapper.
    (e) The symbol is not required on a commercial container too small 
or otherwise unable to accommodate a label, if the symbol is printed on 
the box or package from which the commercial container is removed upon 
dispensing to an ultimate user.
    (f) The symbol is not required on a commercial container containing, 
or on the labeling of, a controlled substance being utilized in clinical 
research involving blind and double blind studies.

[36 FR 7785, Apr. 24, 1971, as amended at 36 FR 18731, Sept. 21, 1971. 
Redesignated at 38 FR 26609, Sept. 24, 1973]



Sec. 1302.04  Location and size of symbol on label and labeling.

    The symbol shall be prominently located on the label or the labeling 
of the commercial container and/or the panel of the commercial container 
normally displayed to dispensers of any controlled substance. The symbol 
on labels shall be clear and large enough to afford easy identification 
of the schedule of the controlled substance upon inspection without 
removal from the dispenser's shelf. The symbol on all other labeling 
shall be clear and large enough to afford prompt identification of the 
controlled substance upon inspection of the labeling.

[62 FR 13958, Mar. 24, 1997]



Sec. 1302.05  Effective dates of labeling requirements.

    All labels on commercial containers of, and all labeling of, a 
controlled substance which either is transferred to another schedule or 
is added to any schedule shall comply with the requirements of Sec. 
1302.03, on or before the effective date established in the final order 
for the transfer or addition.

[62 FR 13958, Mar. 24, 1997]



Sec. 1302.06  Sealing of controlled substances.

    On each bottle, multiple dose vial, or other commercial container of 
any controlled substance, there shall be securely affixed to the 
stopper, cap, lid, covering, or wrapper or such container

[[Page 56]]

a seal to disclose upon inspection any tampering or opening of the 
container.

[62 FR 13958, Mar. 24, 1997]



Sec. 1302.07  Labeling and packaging requirements for imported and
exported substances.

    (a) The symbol requirements of Sec. Sec. 1302.03-1302.05 apply to 
every commercial container containing, and to all labeling of, 
controlled substances imported into the jurisdiction of and/or the 
customs territory of the United States.
    (b) The symbol requirements of Sec. Sec. 1302.03-1302.05 do not 
apply to any commercial containers containing, or any labeling of, a 
controlled substance intended for export from the jurisdiction of the 
United States.
    (c) The sealing requirements of Sec. 1302.06 apply to every bottle, 
multiple dose vial, or other commercial container of any controlled 
substance listed in schedule I or II, or any narcotic controlled 
substance listed in schedule III or IV, imported into, exported from, or 
intended for export from, the jurisdiction of and/or the customs 
territory of the United States.

[62 FR 13958, Mar. 24, 1997]



PART 1303_QUOTAS--Table of Contents



                           General Information

Sec.
1303.01 Scope of part 1303.
1303.02 Definitions.

               Aggregate Production and Procurement Quotas

1303.11 Aggregate production quotas.
1303.12 Procurement quotas.
1303.13 Adjustments of aggregate production quotas.

                     Individual Manufacturing Quotas

1303.21 Individual manufacturing quotas.
1303.22 Procedure for applying for individual manufacturing quotas.
1303.23 Procedure for fixing individual manufacturing quotas.
1303.24 Inventory allowance.
1303.25 Increase in individual manufacturing quotas.
1303.26 Reduction in individual manufacturing quotas.
1303.27 Abandonment of quota.

                                Hearings

1303.31 Hearings generally.
1303.32 Purpose of hearing.
1303.33 Waiver or modification of rules.
1303.34 Request for hearing or appearance; waiver.
1303.35 Burden of proof.
1303.36 Time and place of hearing.
1303.37 Final order.

    Authority: 21 U.S.C. 821, 826, 871(b).

                           General Information



Sec. 1303.01  Scope of part 1303.

    Procedures governing the establishment of production and 
manufacturing quotas on basic classes of controlled substances listed in 
schedules I and II pursuant to section 306 of the Act (21 U.S.C. 826) 
are governed generally by that section and specifically by the sections 
of this part.

[36 FR 7786, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973]



Sec. 1303.02  Definitions.

    Any term contained in this part shall have the definition set forth 
in section 102 of the Act (21 U.S.C. 802) or part 1300 of this chapter.

[62 FR 13958, Mar. 24, 1997]

               Aggregate Production and Procurement Quotas



Sec. 1303.11  Aggregate production quotas.

    (a) The Administrator shall determine the total quantity of each 
basic class of controlled substance listed in Schedule I or II necessary 
to be manufactured during the following calendar year to provide for the 
estimated medical, scientific, research and industrial needs of the 
United States, for lawful export requirements, and for the establishment 
and maintenance of reserve stocks.
    (b) In making his determinations, the Administrator shall consider 
the following factors:
    (1) Total net disposal of the class by all manufacturers during the 
current and 2 preceding years;
    (2) Trends in the national rate of net disposal of the class;
    (3) Total actual (or estimated) inventories of the class and of all 
substances manufactured from the class, and trends in inventory 
accumulation;

[[Page 57]]

    (4) Projected demand for such class as indicated by procurement 
quotas requested pursuant to Sec. 1303.12; and
    (5) Other factors affecting medical, scientific, research, and 
industrial needs in the United States and lawful export requirements, as 
the Administrator finds relevant, including changes in the currently 
accepted medical use in treatment with the class or the substances which 
are manufactured from it, the economic and physical availability of raw 
materials for use in manufacturing and for inventory purposes, yield and 
stability problems, potential disruptions to production (including 
possible labor strikes), and recent unforeseen emergencies such as 
floods and fires.
    (c) The Administrator shall, on or before May 1 of each year, 
publish in the Federal Register, general notice of an aggregate 
production quota for any basic class determined by him under this 
section. A copy of said notice shall be mailed simultaneously to each 
person registered as a bulk manufacturer of the basic class. The 
Administrator shall permit any interested person to file written 
comments on or objections to the proposal and shall designate in the 
notice the time during which such filings may be made. The Administrator 
may, but shall not be required to, hold a public hearing on one or more 
issues raised by the comments and objections filed with him. In the 
event the Administrator decides to hold such a hearing, he shall publish 
notice of the hearing in the Federal Register, which notice shall 
summarize the issues to be heard and shall set the time for the hearing 
which shall not be less than 30 days after the date of publication of 
the notice. After consideration of any comments or objections, or after 
a hearing if one is ordered by the Administrator shall issue and publish 
in the Federal Register his final order determining the aggregate 
production quota for the basic class of controlled substances. The order 
shall include the findings of fact and conclusions of law upon which the 
order is based. The order shall specify the date on which it shall take 
effect. A copy of said order shall be mailed simultaneously to each 
person registered as a bulk manufacturer of the basic class.

[36 FR 7786, Apr. 24, 1971, as amended at 37 FR 15919, Aug. 8, 1972. 
Redesignated at 38 FR 26609, Sept. 24, 1973; 77 FR 4235, Jan. 27, 2012]



Sec. 1303.12  Procurement quotas.

    (a) In order to determine the estimated needs for, and to insure an 
adequate and uninterrupted supply of, basic classes of controlled 
substances listed in Schedules I and II (except raw opium being imported 
by the registrant pursuant to an import permit) the Administrator shall 
issue procurement quotas authorizing persons to procure and use 
quantities of each basic class of such substances for the purpose of 
manufacturing such class into dosage forms or into other substances.
    (b) Any person who is registered to manufacture controlled 
substances listed in any schedule and who desires to use during the next 
calendar year any basic class of controlled substances listed in 
Schedule I or II (except raw opium being imported by the registrant 
pursuant to an import permit) for purposes of manufacturing, shall apply 
on DEA Form 250 for a procurement quota for such basic class. A separate 
application must be made for each basic class desired to be procured or 
used. The applicant shall state whether he intends to manufacture the 
basic class himself or purchase it from another manufacturer. The 
applicant shall state separately each purpose for which the basic class 
is desired, the quantity desired for that purpose during the next 
calendar year, and the quantities used and estimated to be used, if any, 
for that purpose during the current and preceding 2 calendar years. If 
the purpose is to manufacture the basic class into dosage form, the 
applicant shall state the official name, common or usual name, chemical 
name, or brand name of that form. If the purpose is to manufacture 
another substance, the applicant shall state the official name, common 
or usual name, chemical name, or brand name of the substance, and, if a 
controlled substance listed in any schedule, the schedule number and 
Administration Controlled Substances Code Number, as set forth in part 
1308 of this chapter, of the substance. If the purpose is to manufacture 
another

[[Page 58]]

basic class of controlled substance listed in Schedule I or II, the 
applicant shall also state the quantity of the other basic class which 
the applicant has applied to manufacture pursuant to Sec. 1303.22 and 
the quantity of the first basic class necessary to manufacture a 
specified unit of the second basic class. DEA Form 250 shall be filed on 
or before April 1 of the year preceding the calendar year for which the 
procurement quota is being applied. Copies of DEA Form 250 may be 
obtained from, and shall be filed with, the Drug and Chemical Evaluation 
Section, Drug Enforcement Administration. See the Table of DEA Mailing 
Addresses in Sec. 1321.01 of this chapter for the current mailing 
address.
    (c) The Administrator shall, on or before July 1 of the year 
preceding the calendar year during which the quota shall be effective, 
issue to each qualified applicant a procurement quota authorizing him to 
procure and use:
    (1) All quantities of such class necessary to manufacture all 
quantities of other basic classes of controlled substances listed in 
Schedules I and II which the applicant is authorized to manufacture 
pursuant to Sec. 1303.23; and
    (2) Such other quantities of such class as the applicant has applied 
to procure and use and are consistent with his past use, his estimated 
needs, and the total quantity of such class that will be produced.
    (d) Any person to whom a procurement quota has been issued may at 
any time request an adjustment in the quota by applying to the 
Administrator with a statement showing the need for the adjustment. Such 
application shall be filed with the Drug & Chemical Evaluation Section, 
Drug Enforcement Administration. See the Table of DEA Mailing Addresses 
in Sec. 1321.01 of this chapter for the current mailing address. The 
Administrator shall increase or decrease the procurement quota of such 
person if and to the extent that he finds, after considering the factors 
enumerated in paragraph (c) of this section and any occurrences since 
the issuance of the procurement quota, that the need justifies an 
adjustment.
    (e) The following persons need not obtain a procurement quota:
    (1) Any person who is registered to manufacture a basic class of 
controlled substance listed in Schedule I or II and who uses all of the 
quantity he manufactures in the manufacture of a substance not 
controlled under the Act;
    (2) Any person who is registered or authorized to conduct chemical 
analysis with controlled substances (for controlled substances to be 
used in such analysis only); and
    (3) Any person who is registered to conduct research with a basic 
class of controlled substance listed in Schedule I or II and who is 
authorized to manufacture a quantity of such class pursuant to Sec. 
1301.13 of this chapter.
    (f) Any person to whom a procurement quota has been issued, 
authorizing that person to procure and use a quantity of a basic class 
of controlled substances listed in Schedules I or II during the current 
calendar year, shall, at or before the time of giving an order to 
another manufacturer requiring the distribution of a quantity of such 
basic class, certify in writing to such other manufacturer that the 
quantity of such basic class ordered does not exceed the person's unused 
and available procurement quota of such basic class for the current 
calendar year. The written certification shall be executed by the same 
individual who signed the DEA Form 222 transmitting the order. 
Manufacturers shall not fill an order from persons required to apply for 
a procurement quota under paragraph (b) of this section unless the order 
is accompanied by a certification as required under this section. The 
certification required by this section shall contain the following: The 
date of the certification; the name and address of the bulk manufacturer 
to whom the certification is directed; a reference to the number of the 
DEA Form 222 to which the certification applies; the name of the person 
giving the order to which the certification applies; the name of the 
basic class specified in the DEA Form 222 to which the certification 
applies; the appropriate schedule within which is listed the basic class 
specified in the DEA Form 222 to which the certification applies; a 
statement that the quantity (expressed in grams) of the basic class 
specified in the DEA Form 222 to which

[[Page 59]]

the certification applies does not exceed the unused and available 
procurement quota of such basic class, issued to the person giving the 
order, for the current calendar year; and the signature of the 
individual who signed the DEA Form 222 to which the certification 
applies.

[36 FR 7786, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973]

    Editorial Note: For Federal Register citations affecting Sec. 
1303.12, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and at www.fdsys.gov.



Sec. 1303.13  Adjustments of aggregate production quotas.

    (a) The Administrator may at any time increase or reduce the 
aggregate production quota for a basic class of controlled substance 
listed in Schedule I or II which he has previously fixed pursuant to 
Sec. 1303.11.
    (b) In determining to adjust the aggregate production quota, the 
Administrator shall consider the following factors:
    (1) Changes in the demand for that class, changes in the national 
rate of net disposal of the class, and changes in the rate of net 
disposal of the class by registrants holding individual manufacturing 
quotas for that class;
    (2) Whether any increased demand for that class, the national and/or 
individual rates of net disposal of that class are temporary, short 
term, or long term;
    (3) Whether any increased demand for that class can be met through 
existing inventories, increased individual manufacturing quotas, or 
increased importation, without increasing the aggregate production 
quota, taking into account production delays and the probability that 
other individual manufacturing quotas may be suspended pursuant to Sec. 
1303.24(b);
    (4) Whether any decreased demand for that class will result in 
excessive inventory accumulation by all persons registered to handle 
that class (including manufacturers, distributors, practitioners, 
importers, and exporters), notwithstanding the possibility that 
individual manufacturing quotas may be suspended pursuant to Sec. 
1303.24(b) or abandoned pursuant to Sec. 1303.27;
    (5) Other factors affecting medical, scientific, research, and 
industrial needs in the United States and lawful export requirements, as 
the Administrator finds relevant, including changes in the currently 
accepted medical use in treatment with the class or the substances which 
are manufactured from it, the economic and physical availability of raw 
materials for use in manufacturing and for inventory purposes, yield and 
stability problems, potential disruptions to production (including 
possible labor strikes), and recent unforeseen emergencies such as 
floods and fires.
    (c) The Administrator in the event he determines to increase or 
reduce the aggregate production quota for a basic class of controlled 
substance, shall publish in the Federal Register general notice of an 
adjustment in the aggregate production quota for that class determined 
by him under this section. A copy of said notice shall be mailed 
simultaneously to each person registered as a bulk manufacturer of the 
basic class. The Administrator shall permit any interested person to 
file written comments on or objections to the proposal and shall 
designate in the notice the time during which such filings may be made. 
The Administrator may, but shall not be required to, hold a public 
hearing on one or more issues raised by the comments and objections 
filed with him. In the event the Administrator decides to hold such a 
hearing, he shall publish notice of the hearing in the Federal Register, 
which notice shall summarize the issues to be heard and shall set the 
time for the hearing, which shall not be less than 10 days after the 
date of publication of the notice. After consideration of any comments 
or objections, or after a hearing if one is ordered by the 
Administrator, the Administrator shall issue and publish in the Federal 
Register his final order determining the aggregate production for the 
basic class of controlled substance. The order shall include the 
findings of fact and conclusions of law upon which the order is based. 
The order shall specify the date on which it shall take effect. A copy 
of said order shall be mailed simultaneously to each

[[Page 60]]

person registered as a bulk manufacturer of the basic class.

[37 FR 15919, Aug. 8, 1972. Redesignated at 38 FR 26609, Sept. 24, 1973]

                     Individual Manufacturing Quotas



Sec. 1303.21  Individual manufacturing quotas.

    (a) The Administrator shall, on or before July 1 of each year, fix 
for and issue to each person who is registered to manufacture a basic 
class of controlled substance listed in Schedule I or II, and who 
applies for a manufacturing quota, an individual manufacturing quota 
authorizing that person to manufacture during the next calendar year a 
quantity of that basic class. Any manufacturing quota fixed and issued 
by the Administrator shall be subject to his authority to reduce or 
limit it at a later date pursuant to Sec. 1303.26 and to his authority 
to revoke or suspend it at any time pursuant to Sec. Sec. 1301.36 of 
this chapter.
    (b) No individual manufacturing quota shall be required for 
registrants listed in Sec. 1303.12(e).

[36 FR 7786, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973, 
as amended at 62 FR 13958, Mar. 24, 1997]



Sec. 1303.22  Procedure for applying for individual manufacturing quotas.

    Any person who is registered to manufacture any basic class of 
controlled substance listed in Schedule I or II and who desires to 
manufacture a quantity of such class shall apply on DEA Form 189 for a 
manufacturing quota for such quantity of such class. Copies of DEA Form 
189 may be obtained from, and shall be filed (on or before May 1 of the 
year preceding the calendar year for which the manufacturing quota is 
being applied) with, the Drug & Chemical Evaluation Section, Drug 
Enforcement Administration. See the Table of DEA Mailing Addresses in 
Sec. 1321.01 of this chapter for the current mailing address. A 
separate application must be made for each basic class desired to be 
manufactured. The applicant shall state:
    (a) The name and Administration Controlled Substances Code Number, 
as set forth in part 1308 of this chapter, of the basic class.
    (b) For the basic class in each of the current and preceding 2 
calendar years,
    (1) The authorized individual manufacturing quota, if any;
    (2) The actual or estimated quantity manufactured;
    (3) The actual or estimated net disposal;
    (4) The actual or estimated inventory allowance pursuant to Sec. 
1303.24; and
    (5) The actual or estimated inventory as of December 31;
    (c) For the basic class in the next calendar year,
    (1) The desired individual manufacturing quota; and
    (2) Any additional factors which the applicant finds relevant to the 
fixing of his individual manufacturing quota, including the trend of 
(and recent changes in) his and the national rates of net disposal, his 
production cycle and current inventory position, the econolic and 
physical availability of raw materials for use in manufacturing and for 
inventory purposes, yield and stability problems, potential disruptions 
to production (including possible labor strikes) and recent unforeseen 
emergencies such as floods and fires.

[36 FR 7786, Apr. 24, 1971, as amended at 36 FR 13386, July 21, 1971; 37 
FR 15920, Aug. 8, 1972. Redesignated at 38 FR 26609, Sept. 24, 1973, and 
amended at 46 FR 28841, May 29, 1981; 51 FR 5319, Feb. 13, 1986; 62 FR 
13958, Mar. 24, 1997; 75 FR 10677, Mar. 9, 2010]



Sec. 1303.23  Procedure for fixing individual manufacturing quotas.

    (a) In fixing individual manufacturing quotas for a basic class of 
controlled substance listed in Schedule I or II, the Administrator shall 
allocate to each applicant who is currently manufacturing such class a 
quota equal to 100 percent of the estimated net disposal of that 
applicant for the next calendar year, adjusted--
    (1) By the amount necessary to increase or reduce the estimated 
inventory of the applicant on December 31 of the current year to his 
estimated inventory allowance for the next calendar year, pursuant to 
Sec. 1303.24, and
    (2) By any other factors which the Administrator deems relevant to 
the fixing of the individual manufacturing quota of the applicant, 
including the trend of (and recent changes in) his and

[[Page 61]]

the national rates of net disposal, his production cycle and current 
inventory position, the economic and physical availability of raw 
materials for use in manufacturing and for inventory purposes, yield and 
stability problems, potential disruptions to production (including 
possible labor strikes), and recent unforeseen emergencies such as 
floods and fires.
    (b) In fixing individual manufacturing quotas for a basic class of 
controlled substance listed in Schedule I or II, the Administrator shall 
allocate to each applicant who is not currently manufacturing such class 
a quota equal to 100 percent of the reasonably estimated net disposal of 
that applicant for the next calendar year, as determined by the 
Administrator, adjusted--
    (1) By the amount necessary to provide the applicant his estimated 
inventory allowance for the next calendar year, pursuant to Sec. 
1303.24, and
    (2) By any other factors which the Administrator deems relevant to 
the fixing of the individual manufacturing quota of the applicant, 
including the trend of (and recent changes in) the national rate of net 
disposal, his production cycle and current inventory position, the 
economic and physical availability of raw materials for use in 
manufacturing and for inventory purposes, yield and stability problems, 
potential disruptions to production (including possible labor strikes), 
and recent unforeseen emergencies such as floods and fires.
    (c) The Administrator shall, on or before March 1 of each year, 
adjust the individual manufacturing quota allocated for that year to 
each applicant in paragraph (a) of this section by the amount necessary 
to increase or reduce the actual inventory of the applicant to December 
31 of the preceding year to his estimated inventory allowance for the 
current calendar year, pursuant to Sec. 1303.24.

[36 FR 7786, Apr. 24, 1971, as amended at 37 FR 15920, Aug. 8, 1972. 
Redesignated at 38 FR 26609, Sept. 24, 1973]



Sec. 1303.24  Inventory allowance.

    (a) For the purpose of determining individual manufacturing quotas 
pursuant to Sec. 1303.23, each registered manufacturer shall be allowed 
as a part of such quota an amount sufficient to maintain an inventory 
equal to,
    (1) For current manufacturers, 50 percent of his average estimated 
net disposal for the current calendar year and the last preceding 
calendar year; or
    (2) For new manufacturers, 50 percent of his reasonably estimated 
net disposal for the next calendar year as determined by the 
Administrator.
    (b) During each calendar year each registered manufacturer shall be 
allowed to maintain an inventory of a basic class not exceeding 65 
percent of his estimated net disposal of that class for that year, as 
determined at the time his quota for that year was determined. At any 
time the inventory of a basic class held by a manufacturer exceeds 65 
percent of his estimated net disposal, his quota for that class is 
automatically suspended and shall remain suspended until his inventory 
is less than 60 percent of his estimated net disposal. The Administrator 
may, upon application and for good cause shown, permit a manufacturer 
whose quota is, or is likely to be, suspended pursuant to this paragraph 
to continue manufacturing and to accumulate an inventory in excess of 65 
percent of his estimated net disposal, upon such conditions and within 
such limitations as the Administrator may find necessary or desirable.
    (c) If, during a calendar year, a registrant has manufactured the 
entire quantity of a basic class allocated to him under an individual 
manufacturing quota, and his inventory of that class is less than 40 
percent of his estimated net disposal of that class for that year, the 
Administrator may, upon application pursuant to Sec. 1303.25, increase 
the quota of such registrant sufficiently to allow restoration of the 
inventory to 50 percent of the estimated net disposal for that year.

[36 FR 7786, Apr. 24, 1971, as amended at 36 FR 13386, July 21, 1971. 
Redesignated at 38 FR 26609, Sept. 24, 1973]



Sec. 1303.25  Increase in individual manufacturing quotas.

    (a) Any registrant who holds an individual manufacturing quota for a 
basic class of controlled substance listed in

[[Page 62]]

Schedule I or II may file with the Administrator an application on 
Administration Form 189 for an increase in such quota in order for him 
to meet his estimated net disposal, inventory and other requirements 
during the remainder of such calendar year.
    (b) The Administrator, in passing upon a registrant's application 
for an increase in his individual manufacturing quota, shall take into 
consideration any occurrences since the filing of such registrant's 
initial quota application that may require an increased manufacturing 
rate by such registrant during the balance of the calendar year. In 
passing upon such application the Administrator may also take into 
consideration the amount, if any, by which his determination of the 
total quantity for the basic class of controlled substance to be 
manufactured under Sec. 1303.11 exceeds the aggregate of all the 
individual manufacturing quotas for the basic class of controlled 
substance, and the equitable distribution of such excess among other 
registrants.

[36 FR 7786, Apr. 24, 1971, as amended at 36 FR 13386, July 21, 1971. 
Redesignated at 38 FR 26609, Sept. 24, 1973]



Sec. 1303.26  Reduction in individual manufacturing quotas.

    The Administrator may at any time reduce an individual manufacturing 
quota for a basic class of controlled substance listed in Schedule I or 
II which he has previously fixed in order to prevent the aggregate of 
the individual manufacturing quotas and import permits outstanding or to 
be granted from exceeding the aggregate production quota which has been 
established for that class pursuant of Sec. 1303.11, as adjusted 
pursuant to Sec. 1303.13. If a quota assigned to a new manufacturer 
pursuant to Sec. 1303.23(b), or if a quota assigned to any manufacturer 
is increased pursuant to Sec. 1303.24(c), or if an import permit issued 
to an importer pursuant to part 1312 of this chapter, causes the total 
quantity of a basic class to be manufactured and imported during the 
year to exceed the aggregate production quota which has been established 
for that class pursuant to Sec. 1303.11, as adjusted pursuant to Sec. 
1303.13, the Administrator may proportionately reduce the individual 
manufacturing quotas and import permits of all other registrants to keep 
the aggregate production quota within the limits originally established, 
or, alternatively, the Administrator may reduce the individual 
manufacturing quota of any registrant whose quota is suspended pursuant 
to Sec. 1303.24(b) or Sec. 1301.36 of this chapter, or is abandoned 
pursuant to Sec. 1303.27.

[36 FR 7786, Apr. 24, 1971, as amended at 37 FR 15920, Aug. 8, 1972. 
Redesignated at 38 FR 26609, Sept. 24, 1973, as amended at 62 FR 13958, 
Mar. 24, 1997]



Sec. 1303.27  Abandonment of quota.

    Any manufacturer assigned an individual manufacturing quota for any 
basic class pursuant to Sec. 1303.23 may at any time abandon his right 
to manufacture all or any part of such quota by filing with the Drug & 
Chemical Evaluation Section a written notice of such abandonment, 
stating the name and Administration Controlled Substances Code Number, 
as set forth in part 1308 of this chapter, of the substance and the 
amount which he has chosen not to manufacture. The Administrator may, in 
his discretion, allocate such amount among the other manufacturers in 
proportion to their respective quotas.

[36 FR 7786, Apr. 24, 1971, as amended at 36 FR 13386, July 21, 1971. 
Redesignated at 38 FR 26609, Sept. 24, 1973, and amended at 46 FR 28841, 
May 29, 1981; 51 FR 5319, Feb. 13, 1986; 62 FR 13958, Mar. 24, 1997]

                                Hearings



Sec. 1303.31  Hearings generally.

    (a) In any case where the Administrator shall hold a hearing 
regarding the determination of an aggregate production quota pursuant to 
Sec. 1303.11(c), or regarding the adjustment of an aggregate production 
quota pursuant to Sec. 1303.13(c), the procedures for such hearing 
shall be governed generally by the rule making procedures set forth in 
the Administrative Procedure Act (5 U.S.C. 551-559) and specifically by 
section 306 of the Act (21 U.S.C. 826), by Sec. Sec. 1303.32-1303.37, 
and by the procedures for administrative hearings under the Act set 
forth in Sec. Sec. 1316.41-1316.67 of this chapter.

[[Page 63]]

    (b) In any case where the Administrator shall hold a hearing 
regarding the issuance, adjustment, suspension, or denial of a 
procurement quota pursuant to Sec. 1303.12, or the issuance, 
adjustment, suspension, or denial of an individual manufacturing quota 
pursuant to Sec. Sec. 1303.21-1303.27, the procedures for such hearing 
shall be governed generally by the adjudication procedures set forth in 
the Administrative Procedures Act (5 U.S.C. 551-559) and specifically by 
section 306 of the Act (21 U.S.C. 826), by Sec. Sec. 1303.32-1303.37, 
and by the procedures for administrative hearings under the Act set 
forth in Sec. Sec. 1316.41-1316.67 of this chapter.

[36 FR 7786, Apr. 24, 1971, as amended at 37 FR 15920, Aug. 8, 1972. 
Redesignated at 38 FR 26609, Sept. 24, 1973]



Sec. 1303.32  Purpose of hearing.

    (a) The Administrator may, in his sole discretion, hold a hearing 
for the purpose of receiving factual evidence regarding any one or more 
issues (to be specified by him) involved in the determination or 
adjustment of any aggregate production quota.
    (b) If requested by a person applying for or holding a procurement 
quota or an individual manufacturing quota, the Administrator shall hold 
a hearing for the purpose of receiving factual evidence regarding the 
issues involved in the issuance, adjustment, suspension, or denial of 
such quota to such person, but the Administrator need not hold a hearing 
on the suspension of a quota pursuant to Sec. 1301.36 of this chapter 
separate from a hearing on the suspension of registration pursuant to 
those sections.
    (c) Extensive argument should not be offered into evidence but 
rather presented in opening or closing statements of counsel or in 
memoranda or proposed findings of fact and conclusions of law.

[36 FR 7786, Apr. 24, 1971, as amended at 37 FR 15920, Aug. 8, 1972. 
Redesignated at 38 FR 26609, Sept. 24, 1973, as amended at 62 FR 13958, 
Mar. 24, 1997]



Sec. 1303.33  Waiver or modification of rules.

    The Administrator or the presiding officer (with respect to matters 
pending before him) may modify or waive any rule in this part by notice 
in advance of the hearing, if he determines that no party in the hearing 
will be unduly prejudiced and the ends of justice will thereby be 
served. Such notice of modification or waiver shall be made a part of 
the record of the hearing.

[36 FR 7786, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973]



Sec. 1303.34  Request for hearing or appearance; waiver.

    (a) Any applicant or registrant who desires a hearing on the 
issuance, adjustment, suspension, or denial of his procurement and/or 
individual manufacturing quota shall, within 30 days after the date of 
receipt of the issuance, adjustment, suspension, or denial of such 
quota, file with the Administrator a written request for a hearing in 
the form prescribed in Sec. 1316.47 of this chapter. Any interested 
person who desires a hearing on the determination of an aggregate 
production quota shall, within the time prescribed in Sec. 1303.11(c), 
file with the Administrator a written request for a hearing in the form 
prescribed in Sec. 1316.47 of this chapter, including in the request a 
statement of the grounds for a hearing.
    (b) Any interested person who desires to participate in a hearing on 
the determination or adjustment of an aggregate production quota, which 
hearing is ordered by the Administrator pursuant to Sec. 1303.11(c) or 
Sec. 1303.13(c) may do so by filing with the Administrator, within 30 
days of the date of publication of notice of the hearing in the Federal 
Register, a written notice of his intention to participate in such 
hearing in the form prescribed in Sec. 1316.48 of this chapter.
    (c) Any person entitled to a hearing or to participate in a hearing 
pursuant to paragraph (b) of this section, may, within the period 
permitted for filing a request for a hearing of notice of appearance, 
file with the Administrator a waiver of an opportunity for a hearing or 
to participate in a hearing, together with a written statement regarding 
his position on the matters of fact and law involved in such hearing. 
Such statement, if admissible, shall be made a part of the record and 
shall be considered in light of the lack of opportunity for cross-
examination in determining

[[Page 64]]

the weight to be attached to matters of fact asserted therein.
    (d) If any person entitled to a hearing or to participate in a 
hearing pursuant to paragraph (b) of this section, fails to file a 
request for a hearing or notice of appearance, or if he so files and 
fails to appear at the hearing, he shall be deemed to have waived his 
opportunity for the hearing or to participate in the hearing, unless he 
shows good cause for such failure.
    (e) If all persons entitled to a hearing or to participate in a 
hearing waive or are deemed to waive their opportunity for the hearing 
or to participate in the hearing, the Administrator may cancel the 
hearing, if scheduled, and issue his final order pursuant to Sec. 
1303.37 without a hearing.

[36 FR 7786, Apr. 24, 1971, as amended at 36 FR 18731, Sept. 21, 1971; 
37 FR 15920, Aug. 8, 1972. Redesignated at 38 FR 26609, Sept. 24, 1973]



Sec. 1303.35  Burden of proof.

    (a) At any hearing regarding the determination or adjustment of an 
aggregate production quota, each interested person participating in the 
hearing shall have the burden of proving any propositions of fact or law 
asserted by him in the hearing.
    (b) At any hearing regarding the issuance, adjustment, suspension, 
or denial of a procurement or individual manufacturing quota, the 
Administration shall have the burden of proving that the requirements of 
this part for such issuance, adjustment, suspension, or denial are 
satisfied.

[36 FR 7786, Apr. 24, 1971, as amended at 37 FR 15920, Aug. 8, 1972. 
Redesignated at 38 FR 26609, Sept. 24, 1973, as amended at 62 FR 13958, 
Mar. 24, 1997]



Sec. 1303.36  Time and place of hearing.

    (a) If any applicant or registrant requests a hearing on the 
issuance, adjustment, suspension, or denial of his procurement and/or 
individual manufacturing quota pursuant to Sec. 1303.34, the 
Administrator shall hold such hearing. Notice of the hearing shall be 
given to the applicant or registrant of the time and place at least 30 
days prior to the hearing, unless the applicant or registrant waives 
such notice and requests the hearing be held at an earlier time, in 
which case the Administrator shall fix a date for such hearing as early 
as reasonably possible.
    (b) The hearing will commence at the place and time designated in 
the notice given pursuant to paragraph (a) of this section or in the 
notice of hearing published in the Federal Register pursuant to Sec. 
1303.11(c) or Sec. 1303.13 (c), but thereafter it may be moved to a 
different place and may be continued from day to day or recessed to a 
later day without notice other than announcement thereof by the 
presiding officer at the hearing.

[36 FR 7786, Apr. 24, 1971, as amended at 37 FR 15920, Aug. 8, 1972. 
Redesignated at 38 FR 26609, Sept. 24, 1973]



Sec. 1303.37  Final order.

    As soon as practicable after the presiding officer has certified the 
record to the Administrator, the Administrator shall issue his order on 
the determination or adjustment of the aggregate production quota or on 
the issuance, adjustment, suspension, or denial of the procurement quota 
or individual manufacturing quota, as case may be. The order shall 
include the findings of fact and conclusions of law upon which the order 
is based. The order shall specify the date on which it shall take 
effect. The Administrator shall serve one copy of his order upon each 
party in the hearing.

[36 FR 7786, Apr. 24, 1971, as amended at 37 FR 15920, Aug. 8, 1972. 
Redesignated at 38 FR 26609, Sept. 24, 1973]



PART 1304_RECORDS AND REPORTS OF REGISTRANTS--Table of Contents



                           General Information

Sec.
1304.01 Scope of part 1304.
1304.02 Definitions.
1304.03 Persons required to keep records and file reports.
1304.04 Maintenance of records and inventories.
1304.05 Records of authorized central fill pharmacies and retail 
          pharmacies.
1304.06 Records and reports for electronic prescriptions.

                         Inventory Requirements

1304.11 Inventory requirements.

[[Page 65]]

                           Continuing Records

1304.21 General requirements for continuing records.
1304.22 Records for manufacturers, distributors, dispensers, 
          researchers, importers, and exporters.
1304.23 Records for chemical analysts.
1304.24 Records for maintenance treatment programs and detoxification 
          treatment programs.
1304.25 Records for treatment programs which compound narcotics for 
          treatment programs and other locations.
1304.26 Additional recordkeeping requirements applicable to drug 
          products containing gamma-hydroxybutyric acid.

                                 Reports

1304.31 Reports from manufacturers importing narcotic raw material.
1304.32 Reports of manufacturers importing coca leaves.
1304.33 Reports to ARCOS.

                            Online Pharmacies

1304.40 Notification by online pharmacies.
1304.45 Internet Web site disclosure requirements.
1304.50 Disclosure requirements for Web sites of nonpharmacy 
          practitioners that dispense controlled substances by means of 
          the Internet.
1304.55 Reports by online pharmacies.

    Authority: 21 U.S.C. 821, 827, 831, 871(b), 958(e), 965, unless 
otherwise noted.

                           General Information



Sec. 1304.01  Scope of part 1304.

    Inventory and other records and reports required under section 307, 
section 311, or section 1008(e) of the Act (21 U.S.C. 827, 831, and 
958(e)) shall be in accordance with, and contain the information 
required by, those sections and by the sections of this part.

[74 FR 15623, Apr. 6, 2009]



Sec. 1304.02  Definitions.

    Any term contained in this part shall have the definition set forth 
in section 102 of the Act (21 U.S.C. 802) or part 1300 of this chapter.

[62 FR 13958, Mar. 24, 1997]



Sec. 1304.03  Persons required to keep records and file reports.

    (a) Each registrant shall maintain the records and inventories and 
shall file the reports required by this part, except as exempted by this 
section. Any registrant who is authorized to conduct other activities 
without being registered to conduct those activities, either pursuant to 
Sec. 1301.22(b) of this chapter or pursuant to Sec. Sec. 1307.11-
1307.13 of this chapter, shall maintain the records and inventories and 
shall file the reports required by this part for persons registered to 
conduct such activities. This latter requirement should not be construed 
as requiring stocks of controlled substances being used in various 
activities under one registration to be stored separately, nor that 
separate records are required for each activity. The intent of the 
Administration is to permit the registrant to keep one set of records 
which are adapted by the registrant to account for controlled substances 
used in any activity. Also, the Administration does not wish to require 
separate stocks of the same substance to be purchased and stored for 
separate activities. Otherwise, there is no advantage gained by 
permitting several activities under one registration. Thus, when a 
researcher manufactures a controlled item, he must keep a record of the 
quantity manufactured; when he distributes a quantity of the item, he 
must use and keep invoices or order forms to document the transfer; when 
he imports a substance, he keeps as part of his records the 
documentation required of an importer; and when substances are used in 
chemical analysis, he need not keep a record of this because such a 
record would not be required of him under a registration to do chemical 
analysis. All of these records may be maintained in one consolidated 
record system. Similarly, the researcher may store all of his controlled 
items in one place, and every two years take inventory of all items on 
hand, regardless of whether the substances were manufactured by him, 
imported by him, or purchased domestically by him, of whether the 
substances will be administered to subjects, distributed to other 
researchers, or destroyed during chemical analysis.
    (b) A registered individual practitioner is required to keep 
records, as described in Sec. 1304.04, of controlled substances in 
Schedules II, III, IV, and V which are dispensed, other than by 
prescribing or administering in the lawful course of professional 
practice.

[[Page 66]]

    (c) Except as provided in Sec. 1304.06, a registered individual 
practitioner is not required to keep records of controlled substances in 
Schedules II, III, IV, and V that are prescribed in the lawful course of 
professional practice, unless such substances are prescribed in the 
course of maintenance or detoxification treatment of an individual.
    (d) A registered individual practitioner is not required to keep 
records of controlled substances listed in Schedules II, III, IV and V 
which are administered in the lawful course of professional practice 
unless the practitioner regularly engages in the dispensing or 
administering of controlled substances and charges patients, either 
separately or together with charges for other professional services, for 
substances so dispensed or administered. Records are required to be kept 
for controlled substances administered in the course of maintenance or 
detoxification treatment of an individual.
    (e) Each registered mid-level practitioner shall maintain in a 
readily retrievable manner those documents required by the state in 
which he/she practices which describe the conditions and extent of his/
her authorization to dispense controlled substances and shall make such 
documents available for inspection and copying by authorized employees 
of the Administration. Examples of such documentation include protocols, 
practice guidelines or practice agreements.
    (f) Registered persons using any controlled substances while 
conducting preclinical research, in teaching at a registered 
establishment which maintains records with respect to such substances or 
conducting research in conformity with an exemption granted under 
section 505(i) or 512(j) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 355(i) or 360b(j)) at a registered establishment which maintains 
records in accordance with either of those sections, are not required to 
keep records if he/she notifies the Administration of the name, address, 
and registration number of the establishment maintaining such records. 
This notification shall be given at the time the person applies for 
registration or reregistration and shall be made in the form of an 
attachment to the application, which shall be filed with the 
application.
    (g) A distributing registrant who utilizes a freight forwarding 
facility shall maintain records to reflect transfer of controlled 
substances through the facility. These records must contain the date, 
time of transfer, number of cartons, crates, drums or other packages in 
which commercial containers of controlled substances are shipped and 
authorized signatures for each transfer. A distributing registrant may, 
as part of the initial request to operate a freight forwarding facility, 
request permission to store records at a central location. Approval of 
the request to maintain central records would be implicit in the 
approval of the request to operate the facility. Otherwise, a request to 
maintain records at a central location must be submitted in accordance 
with Sec. 1304.04 of this part. These records must be maintained for a 
period of two years.
    (h) A person is required to keep the records and file the reports 
specified in Sec. 1304.06 and part 1311 of this chapter if they are 
either of the following:
    (1) An electronic prescription application provider.
    (2) An electronic pharmacy application provider.

[36 FR 7790, Apr. 24, 1971, as amended at 36 FR 18731, Sept. 21, 1971; 
37 FR 15920, Aug. 8, 1972. Redesignated at 38 FR 26609, Sept. 24, 1973, 
and amended at 50 FR 40523, Oct. 4, 1985; 51 FR 5320, Feb. 13, 1986; 51 
FR 26154, July 21, 1986; 58 FR 31175, June 1, 1993; 62 FR 13958, Mar. 
24, 1997; 65 FR 44679, July 19, 2000; 75 FR 16306, Mar. 31, 2010; 77 FR 
4235, Jan. 27, 2012]



Sec. 1304.04  Maintenance of records and inventories.

    (a) Except as provided in paragraphs (a)(1) and (a)(2) of this 
section, every inventory and other records required to be kept under 
this part must be kept by the registrant and be available, for at least 
2 years from the date of such inventory or records, for inspection and 
copying by authorized employees of the Administration.
    (1) Financial and shipping records (such as invoices and packing 
slips but not executed order forms subject to Sec. Sec. 1305.17 and 
1305.27 of this chapter) may be kept at a central location, rather than 
at the registered location,

[[Page 67]]

if the registrant has notified the Administration of his intention to 
keep central records. Written notification must be submitted by 
registered or certified mail, return receipt requested, in triplicate, 
to the Special Agent in Charge of the Administration in the area in 
which the registrant is located. Unless the registrant is informed by 
the Special Agent in Charge that permission to keep central records is 
denied, the registrant may maintain central records commencing 14 days 
after receipt of his notification by the Special Agent in Charge. All 
notifications must include the following:
    (i) The nature of the records to be kept centrally.
    (ii) The exact location where the records will be kept.
    (iii) The name, address, DEA registration number and type of DEA 
registration of the registrant whose records are being maintained 
centrally.
    (iv) Whether central records will be maintained in a manual, or 
computer readable, form.
    (2) A registered retail pharmacy that possesses additional 
registrations for automated dispensing systems at long term care 
facilities may keep all records required by this part for those 
additional registered sites at the retail pharmacy or other approved 
central location.
    (b) All registrants that are authorized to maintain a central 
recordkeeping system under paragraph (a) of this section shall be 
subject to the following conditions:
    (1) The records to be maintained at the central record location 
shall not include executed order forms and inventories, which shall be 
maintained at each registered location.
    (2) If the records are kept on microfilm, computer media or in any 
form requiring special equipment to render the records easily readable, 
the registrant shall provide access to such equipment with the records. 
If any code system is used (other than pricing information), a key to 
the code shall be provided to make the records understandable.
    (3) The registrant agrees to deliver all or any part of such records 
to the registered location within two business days upon receipt of a 
written request from the Administration for such records, and if the 
Administration chooses to do so in lieu of requiring delivery of such 
records to the registered location, to allow authorized employees of the 
Administration to inspect such records at the central location upon 
request by such employees without a warrant of any kind.
    (4) In the event that a registrant fails to comply with these 
conditions, the Special Agent in Charge may cancel such central 
recordkeeping authorization, and all other central recordkeeping 
authorizations held by the registrant without a hearing or other 
procedures. In the event of a cancellation of central recordkeeping 
authorizations under this paragraph the registrant shall, within the 
time specified by the Special Agent in Charge, comply with the 
requirements of this section that all records be kept at the registered 
location.
    (c) Registrants need not notify the Special Agent in Charge or 
obtain central recordkeeping approval in order to maintain records on an 
in-house computer system.
    (d) ARCOS participants who desire authorization to report from other 
than their registered locations must obtain a separate central reporting 
identifier. Request for central reporting identifiers will be submitted 
to the ARCOS Unit. See the Table of DEA Mailing Addresses in Sec. 
1321.01 of this chapter for the current mailing address.
    (e) All central recordkeeping permits previously issued by the 
Administration expired September 30, 1980.
    (f) Each registered manufacturer, distributor, importer, exporter, 
narcotic treatment program and compounder for narcotic treatment program 
shall maintain inventories and records of controlled substances as 
follows:
    (1) Inventories and records of controlled substances listed in 
Schedules I and II shall be maintained separately from all of the 
records of the registrant; and
    (2) Inventories and records of controlled substances listed in 
Schedules III, IV, and V shall be maintained either separately from all 
other records of the registrant or in such form that

[[Page 68]]

the information required is readily retrievable from the ordinary 
business records of the registrant.
    (g) Each registered individual practitioner required to keep records 
and institutional practitioner shall maintain inventories and records of 
controlled substances in the manner prescribed in paragraph (f) of this 
section.
    (h) Each registered pharmacy shall maintain the inventories and 
records of controlled substances as follows:
    (1) Inventories and records of all controlled substances listed in 
Schedule I and II shall be maintained separately from all other records 
of the pharmacy.
    (2) Paper prescriptions for Schedule II controlled substances shall 
be maintained at the registered location in a separate prescription 
file.
    (3) Inventories and records of Schedules III, IV, and V controlled 
substances shall be maintained either separately from all other records 
of the pharmacy or in such form that the information required is readily 
retrievable from ordinary business records of the pharmacy.
    (4) Paper prescriptions for Schedules III, IV, and V controlled 
substances shall be maintained at the registered location either in a 
separate prescription file for Schedules III, IV, and V controlled 
substances only or in such form that they are readily retrievable from 
the other prescription records of the pharmacy. Prescriptions will be 
deemed readily retrievable if, at the time they are initially filed, the 
face of the prescription is stamped in red ink in the lower right corner 
with the letter ``C'' no less than 1 inch high and filed either in the 
prescription file for controlled substances listed in Schedules I and II 
or in the usual consecutively numbered prescription file for 
noncontrolled substances. However, if a pharmacy employs a computer 
application for prescriptions that permits identification by 
prescription number and retrieval of original documents by prescriber 
name, patient's name, drug dispensed, and date filled, then the 
requirement to mark the hard copy prescription with a red ``C'' is 
waived.
    (5) Records of electronic prescriptions for controlled substances 
shall be maintained in an application that meets the requirements of 
part 1311 of this chapter. The computers on which the records are 
maintained may be located at another location, but the records must be 
readily retrievable at the registered location if requested by the 
Administration or other law enforcement agent. The electronic 
application must be capable of printing out or transferring the records 
in a format that is readily understandable to an Administration or other 
law enforcement agent at the registered location. Electronic copies of 
prescription records must be sortable by prescriber name, patient name, 
drug dispensed, and date filled.

(Authority: 21 U.S.C. 821 and 871(b); 28 CFR 0.100)

[36 FR 7790, Apr. 24, 1971, as amended at 36 FR 13386, July 21, 1971. 
Redesignated at 38 FR 26609, Sept. 24, 1973, and amended at 39 FR 37985, 
Oct. 25, 1974; 45 FR 44266, July 1, 1980; 47 FR 41735, Sept. 22, 1982; 
51 FR 5320, Feb. 13, 1986; 62 FR 13959, Mar. 24, 1997; 70 FR 25466, May 
13, 2005; 75 FR 10677, Mar. 9, 2010; 75 FR 16306, Mar. 31, 2010]



Sec. 1304.05  Records of authorized central fill pharmacies and retail
pharmacies.

    (a) Every retail pharmacy that utilizes the services of a central 
fill pharmacy must keep a record of all central fill pharmacies, 
including name, address and DEA number, that are authorized to fill 
prescriptions on its behalf. The retail pharmacy must also verify the 
registration for each central fill pharmacy authorized to fill 
prescriptions on its behalf. These records must be made available upon 
request for inspection by DEA.
    (b) Every central fill pharmacy must keep a record of all retail 
pharmacies, including name, address and DEA number, for which it is 
authorized to fill prescriptions. The central fill pharmacy must also 
verify the registration for all retail pharmacies for which it is 
authorized to fill prescriptions. These records must be made available 
upon request for inspection by DEA.

[68 FR 37410, June 24, 2003]

[[Page 69]]



Sec. 1304.06  Records and reports for electronic prescriptions.

    (a) As required by Sec. 1311.120 of this chapter, a practitioner 
who issues electronic prescriptions for controlled substances must use 
an electronic prescription application that retains the following 
information:
    (1) The digitally signed record of the information specified in part 
1306 of this chapter.
    (2) The internal audit trail and any auditable event identified by 
the internal audit as required by Sec. 1311.150 of this chapter.
    (b) An institutional practitioner must retain a record of identity 
proofing and issuance of the two-factor authentication credential, where 
applicable, as required by Sec. 1311.110 of this chapter.
    (c) As required by Sec. 1311.205 of this chapter, a pharmacy that 
processes electronic prescriptions for controlled substances must use an 
application that retains the following:
    (1) All of the information required under Sec. 1304.22(c) and part 
1306 of this chapter.
    (2) The digitally signed record of the prescription as received as 
required by Sec. 1311.210 of this chapter.
    (3) The internal audit trail and any auditable event identified by 
the internal audit as required by Sec. 1311.215 of this chapter.
    (d) A registrant and application service provider must retain a copy 
of any security incident report filed with the Administration pursuant 
to Sec. Sec. 1311.150 and 1311.215 of this chapter.
    (e) An electronic prescription or pharmacy application provider must 
retain third party audit or certification reports as required by Sec. 
1311.300 of this chapter.
    (f) An application provider must retain a copy of any notification 
to the Administration regarding an adverse audit or certification report 
filed with the Administration on problems identified by the third-party 
audit or certification as required by Sec. 1311.300 of this chapter.
    (g) Unless otherwise specified, records and reports must be retained 
for two years.

[75 FR 16306, Mar. 31, 2010]

                         Inventory Requirements



Sec. 1304.11  Inventory requirements.

    (a) General requirements. Each inventory shall contain a complete 
and accurate record of all controlled substances on hand on the date the 
inventory is taken, and shall be maintained in written, typewritten, or 
printed form at the registered location. An inventory taken by use of an 
oral recording device must be promptly transcribed. Controlled 
substances shall be deemed to be ``on hand'' if they are in the 
possession of or under the control of the registrant, including 
substances returned by a customer, ordered by a customer but not yet 
invoiced, stored in a warehouse on behalf of the registrant, and 
substances in the possession of employees of the registrant and intended 
for distribution as complimentary samples. A separate inventory shall be 
made for each registered location and each independent activity 
registered, except as provided in paragraph (e)(4) of this section. In 
the event controlled substances in the possession or under the control 
of the registrant are stored at a location for which he/she is not 
registered, the substances shall be included in the inventory of the 
registered location to which they are subject to control or to which the 
person possessing the substance is responsible. The inventory may be 
taken either as of opening of business or as of the close of business on 
the inventory date and it shall be indicated on the inventory.
    (b) Initial inventory date. Every person required to keep records 
shall take an inventory of all stocks of controlled substances on hand 
on the date he/she first engages in the manufacture, distribution, or 
dispensing of controlled substances, in accordance with paragraph (e) of 
this section as applicable. In the event a person commences business 
with no controlled substances on hand, he/she shall record this fact as 
the initial inventory.
    (c) Biennial inventory date. After the initial inventory is taken, 
the registrant shall take a new inventory of all stocks of controlled 
substances on hand at least every two years. The biennial inventory may 
be taken on any date which is within two years of the previous biennial 
inventory date.

[[Page 70]]

    (d) Inventory date for newly controlled substances. On the effective 
date of a rule by the Administrator pursuant to Sec. Sec. 1308.45, 
1308.46, or 1308.47 of this chapter adding a substance to any schedule 
of controlled substances, which substance was, immediately prior to that 
date, not listed on any such schedule, every registrant required to keep 
records who possesses that substance shall take an inventory of all 
stocks of the substance on hand. Thereafter, such substance shall be 
included in each inventory made by the registrant pursuant to paragraph 
(c) of this section.
    (e) Inventories of manufacturers, distributors, dispensers, 
researchers, importers, exporters and chemical analysts. Each person 
registered or authorized (by Sec. 1301.13 or Sec. Sec. 1307.11-1307.13 
of this chapter) to manufacture, distribute, dispense, import, export, 
conduct research or chemical analysis with controlled substances and 
required to keep records pursuant to Sec. 1304.03 shall include in the 
inventory the information listed below.
    (1) Inventories of manufacturers. Each person registered or 
authorized to manufacture controlled substances shall include the 
following information in the inventory:
    (i) For each controlled substance in bulk form to be used in (or 
capable of use in) the manufacture of the same or other controlled or 
non-controlled substances in finished form, the inventory shall include:
    (A) The name of the substance and
    (B) The total quantity of the substance to the nearest metric unit 
weight consistent with unit size.
    (ii) For each controlled substance in the process of manufacture on 
the inventory date, the inventory shall include:
    (A) The name of the substance;
    (B) The quantity of the substance in each batch and/or stage of 
manufacture, identified by the batch number or other appropriate 
identifying number; and
    (C) The physical form which the substance is to take upon completion 
of the manufacturing process (e.g., granulations, tablets, capsules, or 
solutions), identified by the batch number or other appropriate 
identifying number, and if possible the finished form of the substance 
(e.g., 10-milligram tablet or 10-milligram concentration per fluid ounce 
or milliliter) and the number or volume thereof.
    (iii) For each controlled substance in finished form the inventory 
shall include:
    (A) The name of the substance;
    (B) Each finished form of the substance (e.g., 10-milligram tablet 
or 10-milligram concentration per fluid ounce or milliliter);
    (C) The number of units or volume of each finished form in each 
commercial container (e.g., 100-tablet bottle or 3-milliliter vial); and
    (D) The number of commercial containers of each such finished form 
(e.g. four 100-tablet bottles or six 3-milliliter vials).
    (iv) For each controlled substance not included in paragraphs (e)(1) 
(i), (ii) or (iii) of this section (e.g., damaged, defective or impure 
substances awaiting disposal, substances held for quality control 
purposes, or substances maintained for extemporaneous compoundings) the 
inventories shall include:
    (A) The name of the substance;
    (B) The total quantity of the substance to the nearest metric unit 
weight or the total number of units of finished form; and
    (C) The reason for the substance being maintained by the registrant 
and whether such substance is capable of use in the manufacture of any 
controlled substance in finished form.
    (2) Inventories of distributors. Except for reverse distributors 
covered by paragraph (e)(3) of this section, each person registered or 
authorized to distribute controlled substances shall include in the 
inventory the same information required of manufacturers pursuant to 
paragraphs (e)(1)(iii) and (iv) of this section.
    (3) Inventories of dispensers, researchers, and reverse 
distributors. Each person registered or authorized to dispense, conduct 
research, or act as a reverse distributor with controlled substances 
shall include in the inventory the same information required of 
manufacturers pursuant to paragraphs (e)(1)(iii) and (iv) of this 
section. In determining the number of units of each finished form

[[Page 71]]

of a controlled substance in a commercial container which has been 
opened, the dispenser, researcher, or reverse distributor shall do as 
follows:
    (i) If the substance is listed in Schedule I or II, make an exact 
count or measure of the contents, or
    (ii) If the substance is listed in Schedule III, IV or V, make an 
estimated count or measure of the contents, unless the container holds 
more than 1,000 tablets or capsules in which case he/she must make an 
exact count of the contents.
    (4) Inventories of importers and exporters. Each person registered 
or authorized to import or export controlled substances shall include in 
the inventory the same information required of manufacturers pursuant to 
paragraphs (e)(1) (iii) and (iv) of this section. Each such person who 
is also registered as a manufacturer or as a distributor shall include 
in his/her inventory as an importer or exporter only those stocks of 
controlled substances that are actually separated from his stocks as a 
manufacturer or as a distributor (e.g., in transit or in storage for 
shipment).
    (5) Inventories of chemical analysts. Each person registered or 
authorized to conduct chemical analysis with controlled substances shall 
include in his inventory the same information required of manufacturers 
pursuant to paragraphs (e)(1) (iii) and (iv) of this section as to 
substances which have been manufactured, imported, or received by such 
person. If less than 1 kilogram of any controlled substance (other than 
a hallucinogenic controlled substance listed in Schedule I), or less 
than 20 grams of a hallucinogenic substance listed in Schedule I (other 
than lysergic acid diethylamide), or less than 0.5 gram of lysergic acid 
diethylamide, is on hand at the time of inventory, that substance need 
not be included in the inventory. Laboratories of the Administration may 
possess up to 150 grams of any hallucinogenic substance in Schedule I 
without regard to a need for an inventory of those substances. No 
inventory is required of known or suspected controlled substances 
received as evidentiary materials for analysis.

[62 FR 13959, Mar. 24, 1997, as amended at 68 FR 41228, July 11, 2003]

                           Continuing Records



Sec. 1304.21  General requirements for continuing records.

    (a) Every registrant required to keep records pursuant to Sec. 
1304.03 shall maintain on a current basis a complete and accurate record 
of each such substance manufactured, imported, received, sold, 
delivered, exported, or otherwise disposed of by him/her, except that no 
registrant shall be required to maintain a perpetual inventory.
    (b) Separate records shall be maintained by a registrant for each 
registered location except as provided in Sec. 1304.04 (a). In the 
event controlled substances are in the possession or under the control 
of a registrant at a location for which he is not registered, the 
substances shall be included in the records of the registered location 
to which they are subject to control or to which the person possessing 
the substance is responsible.
    (c) Separate records shall be maintained by a registrant for each 
independent activity for which he/she is registered, except as provided 
in Sec. 1304.22(d).
    (d) In recording dates of receipt, importation, distribution, 
exportation, or other transfers, the date on which the controlled 
substances are actually received, imported, distributed, exported, or 
otherwise transferred shall be used as the date of receipt or 
distribution of any documents of transfer (e.g., invoices or packing 
slips).

[36 FR 7792, Apr. 24, 1971, as amended at 36 FR 13386, July 21, 1971. 
Redesignated at 38 FR 26609, Sept. 24, 1973, as amended at 62 FR 13960, 
Mar. 24, 1997]



Sec. 1304.22  Records for manufacturers, distributors, dispensers,
researchers, importers and exporters.

    Each person registered or authorized (by Sec. 1301.13(e) or 
Sec. Sec. 1307.11-1307.13 of this chapter) to manufacture, distribute, 
dispense, import, export or conduct research with controlled substances 
shall maintain records with the information listed below.
    (a) Records for manufacturers. Each person registered or authorized 
to manufacture controlled substances shall maintain records with the 
following information:

[[Page 72]]

    (1) For each controlled substance in bulk form to be used in, or 
capable of use in, or being used in, the manufacture of the same or 
other controlled or noncontrolled substances in finished form,
    (i) The name of the substance;
    (ii) The quantity manufactured in bulk form by the registrant, 
including the date, quantity and batch or other identifying number of 
each batch manufactured;
    (iii) The quantity received from other persons, including the date 
and quantity of each receipt and the name, address, and registration 
number of the other person from whom the substance was received;
    (iv) The quantity imported directly by the registrant (under a 
registration as an importer) for use in manufacture by him/her, 
including the date, quantity, and import permit or declaration number 
for each importation;
    (v) The quantity used to manufacture the same substance in finished 
form, including:
    (A) The date and batch or other identifying number of each 
manufacture;
    (B) The quantity used in the manufacture;
    (C) The finished form (e.g., 10-milligram tablets or 10-milligram 
concentration per fluid ounce or milliliter);
    (D) The number of units of finished form manufactured;
    (E) The quantity used in quality control;
    (F) The quantity lost during manufacturing and the causes therefore, 
if known;
    (G) The total quantity of the substance contained in the finished 
form;
    (H) The theoretical and actual yields; and
    (I) Such other information as is necessary to account for all 
controlled substances used in the manufacturing process;
    (vi) The quantity used to manufacture other controlled and 
noncontrolled substances, including the name of each substance 
manufactured and the information required in paragraph (a)(1)(v) of this 
section;
    (vii) The quantity distributed in bulk form to other persons, 
including the date and quantity of each distribution and the name, 
address, and registration number of each person to whom a distribution 
was made;
    (viii) The quantity exported directly by the registrant (under a 
registration as an exporter), including the date, quantity, and export 
permit or declaration number of each exportation;
    (ix) The quantity distributed or disposed of in any other manner by 
the registrant (e.g., by distribution of complimentary samples or by 
destruction), including the date and manner of distribution or disposal, 
the name, address, and registration number of the person to whom 
distributed, and the quantity distributed or disposed; and
    (x) The originals of all written certifications of available 
procurement quotas submitted by other persons (as required by Sec. 
1303.12(f) of this chapter) relating to each order requiring the 
distribution of a basic class of controlled substance listed in Schedule 
I or II.
    (2) For each controlled substance in finished form,
    (i) The name of the substance;
    (ii) Each finished form (e.g., 10-milligram tablet or 10-milligram 
concentration per fluid ounce or milliliter) and the number of units or 
volume of finished form in each commercial container (e.g., 100-tablet 
bottle or 3-milliliter vial);
    (iii) The number of containers of each such commercial finished form 
manufactured from bulk form by the registrant, including the information 
required pursuant to paragraph (a)(1)(v) of this section;
    (iv) The number of units of finished forms and/or commercial 
containers acquired from other persons, including the date of and number 
of units and/or commercial containers in each acquisition to inventory 
and the name, address, and registration number of the person from whom 
the units were acquired;
    (v) The number of units of finished forms and/or commercial 
containers imported directly by the person (under a registration or 
authorization to import), including the date of, the number of units 
and/or commercial containers in, and the import permit or declaration 
number for, each importation;

[[Page 73]]

    (vi) The number of units and/or commercial containers manufactured 
by the registrant from units in finished form received from others or 
imported, including:
    (A) The date and batch or other identifying number of each 
manufacture;
    (B) The operation performed (e.g., repackaging or relabeling);
    (C) The number of units of finished form used in the manufacture, 
the number manufactured and the number lost during manufacture, with the 
causes for such losses, if known; and
    (D) Such other information as is necessary to account for all 
controlled substances used in the manufacturing process;
    (vii) The number of commercial containers distributed to other 
persons, including the date of and number of containers in each 
reduction from inventory, and the name, address, and registration number 
of the person to whom the containers were distributed; (viii) The number 
of commercial containers exported directly by the registrant (under a 
registration as an exporter), including the date, number of containers 
and export permit or declaration number for each exportation; and
    (ix) The number of units of finished forms and/or commercial 
containers distributed or disposed of in any other manner by the 
registrant (e.g., by distribution of complimentary samples or by 
destruction), including the date and manner of distribution or disposal, 
the name, address, and registration number of the person to whom 
distributed, and the quantity in finished form distributed or disposed.
    (b) Records for distributors. Except as provided in paragraph (e) of 
this section, each person registered or authorized to distribute 
controlled substances shall maintain records with the same information 
required of manufacturers pursuant to paragraphs (a)(2)(i), (ii), (iv), 
(v), (vii), (viii) and (ix) of this section.
    (c) Records for dispensers and researchers. Each person registered 
or authorized to dispense or conduct research with controlled substances 
shall maintain records with the same information required of 
manufacturers pursuant to paragraph (a)(2)(i), (ii), (iv), (vii), and 
(ix) of this section. In addition, records shall be maintained of the 
number of units or volume of such finished form dispensed, including the 
name and address of the person to whom it was dispensed, the date of 
dispensing, the number of units or volume dispensed, and the written or 
typewritten name or initials of the individual who dispensed or 
administered the substance on behalf of the dispenser. In addition to 
the requirements of this paragraph, practitioners dispensing gamma-
hydroxybutyric acid under a prescription must also comply with Sec. 
1304.26.
    (d) Records for importers and exporters. Each person registered or 
authorized to import or export controlled substances shall maintain 
records with the same information required of manufacturers pursuant to 
paragraphs (a)(2) (i), (iv), (v) and (vii) of this section. In addition, 
the quantity disposed of in any other manner by the registrant (except 
quantities used in manufacturing by an importer under a registration as 
a manufacturer), which quantities are to be recorded pursuant to 
paragraphs (a)(1) (iv) and (v) of this section; and the quantity (or 
number of units or volume in finished form) exported, including the 
date, quantity (or number of units or volume), and the export permit or 
declaration number for each exportation, but excluding all quantities 
(and number of units and volumes) manufactured by an exporter under a 
registration as a manufacturer, which quantities (and numbers of units 
and volumes) are to be recorded pursuant to paragraphs (a)(1)(xiii) or 
(a)(2)(xiii) of this section.
    (e) Records for reverse distributors. Each person registered to 
distribute controlled substances as a reverse distributor shall maintain 
records with the following information for each controlled substance:
    (1) For each controlled substance in bulk form the following:
    (i) The name of the controlled substance.
    (ii) The total quantity of the controlled substance to the nearest 
metric unit weight consistent with unit size.
    (iii) The quantity received from other persons, including the date 
and quantity of each receipt and the name, address, and registration 
number of the

[[Page 74]]

other person from whom the controlled substance was received.
    (iv) The quantity returned to the original manufacturer of the 
controlled substance or the manufacturer's agent, including the date of 
and quantity of each distribution and the name, address and registration 
number of the manufacturer or manufacturer's agent to whom the 
controlled substance was distributed.
    (v) The quantity disposed of including the date and manner of 
disposal and the signatures of two responsible employees of the 
registrant who witnessed the disposal.
    (2) For each controlled substance in finished form the following:
    (i) The name of the substance.
    (ii) Each finished form (e.g., 10-milligram tablet or 10-milligram 
concentration per fluid ounce or milliliter) and the number of units or 
volume of finished form in each commercial container (e.g., 100-tablet 
bottle or 3-milliliter vial).
    (iii) The number of commercial containers of each such finished form 
received from other persons, including the date of and number of 
containers in each receipt and the name, address, and registration 
number of the person from whom the containers were received.
    (iv) The number of commercial containers of each such finished form 
distributed back to the original manufacturer of the substance or the 
manufacturer's agent, including the date of and number of containers in 
each distribution and the name, address, and registration number of the 
manufacturer or manufacturer's agent to whom the containers were 
distributed.
    (v) The number of units or volume of finished forms and/or 
commercial containers disposed of including the date and manner of 
disposal, the quantity of the substance in finished form disposed, and 
the signatures of two responsible employees of the registrant who 
witnessed the disposal.

[62 FR 13960, Mar. 24, 1997, as amended at 68 FR 41229, July 11, 2003; 
70 FR 293, Jan. 4, 2005]



Sec. 1304.23  Records for chemical analysts.

    (a) Each person registered or authorized (by Sec. 1301.22(b) of 
this chapter) to conduct chemical analysis with controlled substances 
shall maintain records with the following information (to the extent 
known and reasonably ascertainable by him) for each controlled 
substance:
    (1) The name of the substance;
    (2) The form or forms in which the substance is received, imported, 
or manufactured by the registrant (e.g., powder, granulation, tablet, 
capsule, or solution) and the concentration of the substance in such 
form (e.g., C.P., U.S.P., N.F., 10-milligram tablet or 10-milligram 
concentration per milliliter);
    (3) The total number of the forms received, imported or manufactured 
(e.g., 100 tablets, thirty 1-milliliter vials, or 10 grams of powder), 
including the date and quantity of each receipt, importation, or 
manufacture and the name, address, and registration number, if any, of 
the person from whom the substance was received;
    (4) The quantity distributed, exported, or destroyed in any manner 
by the registrant (except quantities used in chemical analysis or other 
laboratory work), including the date and manner of distribution, 
exportation, or destruction, and the name, address, and registration 
number, if any, of each person to whom the substance was distributed or 
exported.
    (b) Records of controlled substances used in chemical analysis or 
other laboratory work are not required.
    (c) Records relating to known or suspected controlled substances 
received as evidentiary material for analysis are not required under 
paragraph (a) of this section.

[36 FR 7793, Apr. 24, 1971, as amended at 36 FR 13386, July 21, 1971; 36 
FR 18732, Sept. 21, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973, 
and further redesignated at 62 FR 13961, Mar. 24, 1997]



Sec. 1304.24  Records for maintenance treatment programs and 
detoxification treatment programs.

    (a) Each person registered or authorized (by Sec. 1301.22 of this 
chapter) to maintain and/or detoxify controlled substance users in a 
narcotic treatment program shall maintain records with the following 
information for each narcotic controlled substance:

[[Page 75]]

    (1) Name of substance;
    (2) Strength of substance;
    (3) Dosage form;
    (4) Date dispensed;
    (5) Adequate identification of patient (consumer);
    (6) Amount consumed;
    (7) Amount and dosage form taken home by patient; and
    (8) Dispenser's initials.
    (b) The records required by paragraph (a) of this section will be 
maintained in a dispensing log at the narcotic treatment program site 
and will be maintained in compliance with Sec. 1304.22 without 
reference to Sec. 1304.03.
    (c) All sites which compound a bulk narcotic solution from bulk 
narcotic powder to liquid for on-site use must keep a separate batch 
record of the compounding.
    (d) Records of identity, diagnosis, prognosis, or treatment of any 
patients which are maintained in connection with the performance of a 
narcotic treatment program shall be confidential, except that such 
records may be disclosed for purposes and under the circumstances 
authorized by part 310 and 42 CFR part 2.

[39 FR 37985, Oct. 25, 1974. Redesignated and amended at 62 FR 13961, 
Mar. 24, 1997]



Sec. 1304.25  Records for treatment programs which compound narcotics
for treatment programs and other locations.

    Each person registered or authorized by Sec. 1301.22 of this 
chapter to compound narcotic drugs for off-site use in a narcotic 
treatment program shall maintain records which include the following 
information for each narcotic drug:
    (a) For each narcotic controlled substance in bulk form to be used 
in, or capable of use in, or being used in, the compounding of the same 
or other noncontrolled substances in finished form:
    (1) The name of the substance;
    (2) The quantity compounded in bulk form by the registrant, 
including the date, quantity and batch or other identifying number of 
each batch compounded;
    (3) The quantity received from other persons, including the date and 
quantity of each receipt and the name, address and registration number 
of the other person from whom the substance was received;
    (4) The quantity imported directly by the registrant (under a 
registration as an importer) for use in compounding by him, including 
the date, quantity and import permit or declaration number of each 
importation;
    (5) The quantity used to compound the same substance in finished 
form, including:
    (i) The date and batch or other identifying number of each 
compounding;
    (ii) The quantity used in the compound;
    (iii) The finished form (e.g., 10-milligram tablets or 10-milligram 
concentration per fluid ounce or milliliter;
    (iv) The number of units of finished form compounded;
    (v) The quantity used in quality control;
    (vi) The quantity lost during compounding and the causes therefore, 
if known;
    (vii) The total quantity of the substance contained in the finished 
form;
    (viii) The theoretical and actual yields; and
    (ix) Such other information as is necessary to account for all 
controlled substances used in the compounding process;
    (6) The quantity used to manufacture other controlled and non-
controlled substances; including the name of each substance manufactured 
and the information required in paragraph (a)(5) of this section;
    (7) The quantity distributed in bulk form to other programs, 
including the date and quantity of each distribution and the name, 
address and registration number of each program to whom a distribution 
was made;
    (8) The quantity exported directly by the registrant (under a 
registration as an exporter), including the date, quantity, and export 
permit or declaration number of each exploration; and
    (9) The quantity disposed of by destruction, including the reason, 
date and manner of destruction. All other destruction of narcotic 
controlled substances will comply with Sec. 1307.22.
    (b) For each narcotic controlled substance in finished form:
    (1) The name of the substance;

[[Page 76]]

    (2) Each finished form (e.g., 10-milligram tablet or 10 milligram 
concentration per fluid ounce or milliliter) and the number of units or 
volume or finished form in each commercial container (e.g., 100-tablet 
bottle or 3-milliliter vial);
    (3) The number of containers of each such commercial finished form 
compounded from bulk form by the registrant, including the information 
required pursuant to paragraph (a)(5) of this section;
    (4) The number of units of finished forms and/or commercial 
containers received from other persons, including the date of and number 
of units and/or commercial containers in each receipt and the name, 
address and registration number of the person from whom the units were 
received;
    (5) The number of units of finished forms and/or commercial 
containers imported directly by the person (under a registration or 
authorization to import), including the date of, the number of units 
and/or commercial containers in, and the import permit or declaration 
number for, each importation;
    (6) The number of units and/or commercial containers compounded by 
the registrant from units in finished form received from others or 
imported, including:
    (i) The date and batch or other identifying number of each 
compounding;
    (ii) The operation performed (e.g., repackaging or relabeling);
    (iii) The number of units of finished form used in the compound, the 
number compounded and the number lost during compounding, with the 
causes for such losses, if known; and
    (iv) Such other information as is necessary to account for all 
controlled substances used in the compounding process;
    (7) The number of containers distributed to other programs, 
including the date, the number of containers in each distribution, and 
the name, address and registration number of the program to whom the 
containers were distributed;
    (8) The number of commercial containers exported directly by the 
registrant (under a registration as an exporter), including the date, 
number of containers and export permit or declaration number for each 
exportation; and
    (9) The number of units of finished forms and/or commercial 
containers destroyed in any manner by the registrant, including the 
reason, the date and manner of destruction. All other destruction of 
narcotic controlled substances will comply with Sec. 1307.22.

[39 FR 37985, Oct. 25, 1974. Redesignated at 62 FR 13961, Mar. 24, 1997]



Sec. 1304.26  Additional recordkeeping requirements applicable to drug
products containing gamma-hydroxybutyric acid.

    In addition to the recordkeeping requirements for dispensers and 
researchers provided in Sec. 1304.22, practitioners dispensing gamma-
hydroxybutyric acid that is manufactured or distributed in accordance 
with an application under section 505 of the Federal Food, Drug, and 
Cosmetic Act must maintain and make available for inspection and copying 
by the Attorney General, all of the following information for each 
prescription:
    (a) Name of the prescribing practitioner.
    (b) Prescribing practitioner's Federal and State registration 
numbers, with the expiration dates of these registrations.
    (c) Verification that the prescribing practitioner possesses the 
appropriate registration to prescribe this controlled substance.
    (d) Patient's name and address.
    (e) Patient's insurance provider, if available.

[70 FR 293, Jan. 4, 2005]

                                 Reports



Sec. 1304.31  Reports from manufacturers importing narcotic raw material.

    (a) Every manufacturer which imports or manufactures from narcotic 
raw material (opium, poppy straw, and concentrate of poppy straw) shall 
submit information which accounts for the importation and for all 
manufacturing operations performed between importation and the 
production in bulk or finished marketable products, standardized in 
accordance with the U.S. Pharmacopeia, National Formulary or other 
recognized medical standards. Reports

[[Page 77]]

shall be signed by the authorized official and submitted quarterly on 
company letterhead to the Drug and Chemical Evaluation Section, Drug 
Enforcement Administration, on or before the 15th day of the month 
immediately following the period for which it is submitted. See the 
Table of DEA Mailing Addresses in Sec. 1321.01 of this chapter for the 
current mailing address.
    (b) The following information shall be submitted for each type of 
narcotic raw material (quantities are expressed as grams of anhydrous 
morphine alkaloid):
    (1) Beginning inventory;
    (2) Gains on reweighing;
    (3) Imports;
    (4) Other receipts;
    (5) Quantity put into process;
    (6) Losses on reweighing;
    (7) Other dispositions and
    (8) Ending inventory.
    (c) The following information shall be submitted for each narcotic 
raw material derivative including morphine, codeine, thebaine, 
oxycodone, hydrocodone, medicinal opium, manufacturing opium, crude 
alkaloids and other derivatives (quantities are expressed as grams of 
anhydrous base or anhydrous morphine alkaloid for manufacturing opium 
and medicinal opium):
    (1) Beginning inventory;
    (2) Gains on reweighing;
    (3) Quantity extracted from narcotic raw material;
    (4) Quantity produced/manufactured/synthesized;
    (5) Quantity sold;
    (6) Quantity returned to conversion processes for reworking;
    (7) Quantity used for conversion;
    (8) Quantity placed in process;
    (9) Other dispositions;
    (10) Losses on reweighing and
    (11) Ending inventory.
    (d) The following information shall be submitted for importation of 
each narcotic raw material:
    (1) Import permit number;
    (2) Date shipment arrived at the United States port of entry;
    (3) Actual quantity shipped;
    (4) Assay (percent) of morphine, codeine and thebaine and
    (5) Quantity shipped, expressed as anhydrous morphine alkaloid.
    (e) Upon importation of crude opium, samples will be selected and 
assays made by the importing manufacturer in the manner and according to 
the method specified in the U.S. Pharmacopoeia. Where final assay data 
is not determined at the time of rendering report, the report shall be 
made on the basis of the best data available, subject to adjustment, and 
the necessary adjusting entries shall be made on the next report.
    (f) Where factory procedure is such that partial withdrawals of 
opium are made from individual containers, there shall be attached to 
each container a stock record card on which shall be kept a complete 
record of all withdrawals therefrom.
    (g) All in-process inventories should be expressed in terms of end-
products and not precursors. Once precursor material has been changed or 
placed into process for the manufacture of a specified end-product, it 
must no longer be accounted for as precursor stocks available for 
conversion or use, but rather as end-product in-process inventories.

[62 FR 13961, Mar. 24, 1997, as amended at 75 FR 10677, Mar. 9, 2010]



Sec. 1304.32  Reports of manufacturers importing coca leaves.

    (a) Every manufacturer importing or manufacturing from raw coca 
leaves shall submit information accounting for the importation and for 
all manufacturing operations performed between the importation and the 
manufacture of bulk or finished products standardized in accordance with 
U.S. Pharmacopoeia, National Formulary, or other recognized standards. 
The reports shall be submitted quarterly on company letterhead to the 
Drug and Chemical Evaluation Section, Drug Enforcement Administration, 
on or before the 15th day of the month immediately following the period 
for which it is submitted. See the Table of DEA Mailing Addresses in 
Sec. 1321.01 of this chapter for the current mailing address.
    (b) The following information shall be submitted for raw coca leaf, 
ecgonine, ecgonine for conversion or further manufacture, 
benzoylecgonine, manufacturing coca extracts (list for

[[Page 78]]

tinctures and extracts; and others separately), other crude alkaloids 
and other derivatives (quantities should be reported as grams of actual 
quantity involved and the cocaine alkaloid content or equivalency):
    (1) Beginning inventory;
    (2) Imports;
    (3) Gains on reweighing;
    (4) Quantity purchased;
    (5) Quantity produced;
    (6) Other receipts;
    (7) Quantity returned to processes for reworking;
    (8) Material used in purification for sale;
    (9) Material used for manufacture or production;
    (10) Losses on reweighing;
    (11) Material used for conversion;
    (12) Other dispositions and
    (13) Ending inventory.
    (c) The following information shall be submitted for importation of 
coca leaves:
    (1) Import permit number;
    (2) Date the shipment arrived at the United States port of entry;
    (3) Actual quantity shipped;
    (4) Assay (percent) of cocaine alkaloid and
    (5) Total cocaine alkaloid content.
    (d) Upon importation of coca leaves, samples will be selected and 
assays made by the importing manufacturer in accordance with recognized 
chemical procedures. These assays shall form the basis of accounting for 
such coca leaves, which shall be accounted for in terms of their cocaine 
alkaloid content or equivalency or their total anhydrous coca alkaloid 
content. Where final assay data is not determined at the time of 
submission, the report shall be made on the basis of the best data 
available, subject to adjustment, and the necessary adjusting entries 
shall be made on the next report.
    (e) Where factory procedure is such that partial withdrawals of 
medicinal coca leaves are made from individual containers, there shall 
be attached to the container a stock record card on which shall be kept 
a complete record of withdrawals therefrom.
    (f) All in-process inventories should be expressed in terms of end-
products and not precursors. Once precursor material has been changed or 
placed into process for the manufacture of a specified end-product, it 
must no longer be accounted for as precursor stocks available for 
conversion or use, but rather as end-product in-process inventories.

[62 FR 13962, Mar. 24, 1997, as amended at 75 FR 10678, Mar. 9, 2010]



Sec. 1304.33  Reports to ARCOS.

    (a) Reports generally. All reports required by this section shall be 
filed with the ARCOS Unit on DEA Form 333, or on media which contains 
the data required by DEA Form 333 and which is acceptable to the ARCOS 
Unit. See the Table of DEA Mailing Addresses in Sec. 1321.01 of this 
chapter for the current mailing address.
    (b) Frequency of reports. Acquisition/Distribution transaction 
reports shall be filed every quarter not later than the 15th day of the 
month succeeding the quarter for which it is submitted; except that a 
registrant may be given permission to file more frequently (but not more 
frequently than monthly), depending on the number of transactions being 
reported each time by that registrant. Inventories shall provide data on 
the stocks of each reported controlled substance on hand as of the close 
of business on December 31 of each year, indicating whether the 
substance is in storage or in process of manufacturing. These reports 
shall be filed not later than January 15 of the following year. 
Manufacturing transaction reports shall be filed annually for each 
calendar year not later than January 15 of the following year, except 
that a registrant may be given permission to file more frequently (but 
not more frequently than quarterly).
    (c) Persons reporting. For controlled substances in Schedules I, II, 
narcotic controlled substances in Schedule III, and gamma-hydroxybutyric 
acid drug product controlled substances in Schedule III, each person who 
is registered to manufacture in bulk or dosage form, or to package, 
repackage, label or relabel, and each person who is registered to 
distribute, including each person who is registered to reverse 
distribute, shall report acquisition/distribution transactions. In 
addition to reporting acquisition/distribution

[[Page 79]]

transactions, each person who is registered to manufacture controlled 
substances in bulk or dosage form shall report manufacturing 
transactions on controlled substances in Schedules I and II, each 
narcotic controlled substance listed in Schedules III, IV, and V, gamma-
hydroxybutyric acid drug product controlled substances in Schedule III, 
and on each psychotropic controlled substance listed in Schedules III 
and IV as identified in paragraph (d) of this section.
    (d) Substances covered. (1) Manufacturing and acquisition/
distribution transaction reports shall include data on each controlled 
substance listed in Schedules I and II, on each narcotic controlled 
substance listed in Schedule III (but not on any material, compound, 
mixture or preparation containing a quantity of a substance having a 
stimulant effect on the central nervous system, which material, 
compound, mixture or preparation is listed in Schedule III or on any 
narcotic controlled substance listed in Schedule V), and on gamma-
hydroxybutyric acid drug products listed in Schedule III. Additionally, 
reports on manufacturing transactions shall include the following 
psychotropic controlled substances listed in Schedules III and IV:
    (i) Schedule III
    (A) Benzphetamine;
    (B) Cyclobarbital;
    (C) Methyprylon; and
    (D) Phendimetrazine.
    (ii) Schedule IV
    (A) Barbital;
    (B) Diethylpropion (Amfepramone);
    (C) Ethchlorvynol;
    (D) Ethinamate;
    (E) Lefetamine (SPA);
    (F) Mazindol;
    (G) Meprobamate;
    (H) Methylphenobarbital;
    (I) Phenobarbital;
    (J) Phentermine; and
    (K) Pipradrol.
    (2) Data shall be presented in such a manner as to identify the 
particular form, strength, and trade name, if any, of the product 
containing the controlled substancefor which the report is being made. 
For this purpose, persons filing reports shall utilize the National Drug 
Code Number assigned to the product under the National Drug Code System 
of the Food and Drug Administration.
    (e) Transactions reported. Acquisition/distribution transaction 
reports shall provide data on each acquisition to inventory (identifying 
whether it is, e.g., by purchase or transfer, return from a customer, or 
supply by the Federal Government) and each reduction from inventory 
(identifying whether it is, e.g., by sale or transfer, theft, 
destruction or seizure by Government agencies). Manufacturing reports 
shall provide data on material manufactured, manufacture from other 
material, use in manufacturing other material and use in producing 
dosage forms.
    (f) Exceptions. A registered institutional practitioner who 
repackages or relabels exclusively for distribution or who distributes 
exclusively to (for dispensing by) agents, employees, or affiliated 
institutional practitioners of the registrant may be exempted from 
filing reports under this section by applying to the ARCOS Unit of the 
Administration.

(Approved by the Office of Management and Budget under control number 
1117-0003)

[62 FR 13962, Mar. 24, 1997, as amended at 68 FR 41229, July 11, 2003; 
70 FR 294, Jan. 4, 2005; 75 FR 10678, Mar. 9, 2010]

                            Online Pharmacies



Sec. 1304.40  Notification by online pharmacies.

    (a) Thirty days prior to offering a controlled substance for sale, 
delivery, distribution, or dispensing by means of the Internet, an 
online pharmacy shall:
    (1) Notify the Administrator of its intent to do so by submitting an 
application for a modified registration in accordance with Sec. Sec. 
1301.13 and 1301.19 of this chapter, with such application containing 
the information required by this section; and
    (2) Notify the State boards of pharmacy in any States in which the 
online pharmacy offers to sell, deliver, distribute, or dispense 
controlled substances.
    (b) The following information must be included in the notification 
submitted under paragraph (a) of this section:

[[Page 80]]

    (1) The pharmacy's Internet Pharmacy Site Disclosure information 
required to be posted on the homepage of the online pharmacy's Internet 
site under section 311(c) of the Act (21 U.S.C. 831(c)) and Sec. 
1304.45 of this part.
    (2) Certification that the information disclosed on its Internet 
site under the Internet Pharmacy Site Disclosure is true and accurate. 
The statement shall be in a form similar to the following: ``The above-
named pharmacy, a DEA registrant, certifies, under penalty of perjury, 
that the information contained in this statement is true and accurate.''
    (3) Each Internet site address utilized by the online pharmacy and a 
certification that the online pharmacy shall notify the Administrator of 
any change in any such Internet address at least 30 days in advance. In 
the event that a pharmacy delivers, distributes, or dispenses controlled 
substances pursuant to orders made on, through, or on behalf of, more 
than one Web site, the pharmacy shall provide, for purposes of complying 
with this paragraph, the Internet site address of each such site.
    (4) The DEA registration numbers of:
    (i) Every pharmacy that delivers, distributes, or dispenses 
controlled substances pursuant to orders made on, through, or on behalf 
of, each Web site referred to in paragraph (b)(3) of this section; and
    (ii) Every practitioner who has a contractual relationship to 
provide medical evaluations or issue prescriptions for controlled 
substances, through referrals from the Web site or at the request of the 
owner or operator of the Web site, or any employee or agent thereof.
    (c) An online pharmacy that is in operation at the time Public Law 
110-425 becomes effective (April 13, 2009) must make the notifications 
required in this section on or before May 13, 2009. However, in 
accordance with section 401(h) of the Act (21 U.S.C. 841(h)), as of 
April 13, 2009, it is unlawful for any online pharmacy to deliver, 
distribute, or dispense a controlled substance by means of the Internet 
unless such online pharmacy is validly registered with a modification of 
such registration authorizing such activity.
    (d) On and after the date an online pharmacy makes the notifications 
required under this section, each online pharmacy shall display on the 
homepage of its Internet site, a declaration that it has made such 
notifications to the Administrator in the following form: ``In 
accordance with the Controlled Substances Act and the DEA regulations, 
this online pharmacy has made the notifications to the DEA Administrator 
required by 21 U.S.C. 831 and 21 CFR 1304.40.''
    (e)(1) Except as provided in paragraphs (e)(2) and (e)(3) of this 
section, if any of the information required to be submitted under this 
section changes after the online pharmacy submits the notification to 
the Administrator, the online pharmacy shall notify the Administrator of 
the updated information no later than 30 days before the change becomes 
effective via the online process.
    (2) If a pharmacy referred to in paragraph (b)(4)(i) of this section 
ceases to deliver, distribute, or dispense controlled substances 
pursuant to orders made on, through, or on behalf of, each Web site 
referred to in paragraph (b)(3) of this section, the online pharmacy 
shall notify the Administrator no later than 30 days after the change 
becomes effective via the online process.
    (3) If a practitioner referred to in paragraph (b)(4)(ii) of this 
section ceases to have a contractual relationship with the online 
pharmacy, the online pharmacy shall notify the Administrator no later 
than 30 days after the change becomes effective via the online process.

[74 FR 15623, Apr. 6, 2009]



Sec. 1304.45  Internet Web site disclosure requirements.

    (a) Each online pharmacy shall display, at all times and in a 
visible and clear manner, on its homepage a statement that it complies 
with the requirements of section 311 of the Act (21 U.S.C. 831) with 
respect to the delivery or sale or offer for sale of controlled 
substances. This statement must include the name of the pharmacy as it 
appears on the DEA Certificate of Registration.
    (b) Each online pharmacy shall clearly display the following 
information on

[[Page 81]]

the homepage of each Internet site it operates, or on a page directly 
linked to the homepage. If the information is displayed on a page 
directly linked to the homepage, that link on the homepage must be 
visible and clear. The information must be displayed for each pharmacy 
that delivers, distributes, or dispenses controlled substances pursuant 
to orders made on, through, or on behalf of that Web site.
    (1) The name and address of the pharmacy as it appears on the 
pharmacy's DEA Certificate of Registration.
    (2) The pharmacy's telephone number and e-mail address.
    (3) The name, professional degree, and States of licensure of the 
pharmacist-in-charge, and a telephone number at which the pharmacist-in-
charge can be contacted.
    (4) A list of the States in which the pharmacy is licensed to 
dispense controlled substances.
    (5) A certification that the pharmacy is registered under part 1301 
of this chapter with a modification of its registration authorizing it 
to deliver, distribute, or dispense controlled substances by means of 
the Internet.
    (6) The name, address, telephone number, professional degree, and 
States of licensure with State license number of any practitioner who 
has a contractual relationship to provide medical evaluations or issue 
prescriptions for controlled substances, through referrals from the Web 
site or at the request of the owner or operator of the Web site, or any 
employee or agent thereof.
    (7) The following statement: ``This online pharmacy is obligated to 
comply fully with the Controlled Substances Act and DEA regulations. As 
part of this obligation, this online pharmacy has obtained a modified 
DEA registration authorizing it to operate as an online pharmacy. In 
addition, this online pharmacy will only dispense a controlled substance 
to a person who has a valid prescription issued for a legitimate medical 
purpose based upon a medical relationship with a prescribing 
practitioner. This includes at least one prior in-person medical 
evaluation in accordance with section 309 of the Controlled Substances 
Act (21 U.S.C. 829) or a medical evaluation via telemedicine in 
accordance with section 102(54) of the Controlled Substances Act (21 
U.S.C. 802(54)).''

[74 FR 15623, Apr. 6, 2009]



Sec. 1304.50  Disclosure requirements for Web sites of nonpharmacy 
practitioners that dispense controlled substances by means of the 

Internet.

    For a Web site to identify itself as being exempt from the 
definition of an online pharmacy by virtue of section 102(52)(B)(ii) of 
the Act (21 U.S.C. 802(52)(B)(ii)) and Sec. 1300.04(h)(2) of this 
chapter, the Web site shall post in a visible and clear manner on its 
homepage, or on a page directly linked thereto in which the hyperlink is 
also visible and clear on the homepage, a list of the DEA-registered 
nonpharmacy practitioners who are affiliated with the Web site. Any 
nonpharmacy practitioner affiliated with such a Web site is responsible 
for compliance with this section. An institutional practitioner that 
otherwise complies with the requirements of the Act and this chapter 
will be deemed to meet the requirements of this section if, in lieu of 
posting the names of each affiliated individual practitioner, it posts 
its name (as it appears on its Certificate of Registration) in a visible 
and clear manner on its homepage and in a manner that identifies itself 
as being responsible for the operation of the Web site.

[74 FR 15623, Apr. 6, 2009]



Sec. 1304.55  Reports by online pharmacies.

    (a) Each online pharmacy shall report to the Administrator the total 
quantity of each controlled substance that the pharmacy has dispensed 
each calendar month. The report must include the total quantity of such 
dispensing by any means, regardless of whether the controlled substances 
are dispensed by means of the Internet. Thus, such reporting shall 
include all controlled substances dispensed via Internet transactions, 
mail-order transactions, face-to-face transactions, or any other means. 
However, the pharmacy is not required to describe in its report to the 
Administrator such means of dispensing. Such reporting is required for 
every calendar month in

[[Page 82]]

which the total quantity of controlled substances dispensed by the 
pharmacy meets or exceeds one of the following thresholds:
    (1) 100 or more prescriptions for controlled substances filled; or
    (2) 5,000 or more dosage units dispensed of all controlled 
substances combined.
    (b) Each online pharmacy shall report a negative response if, during 
a given calendar month, its total dispensing of controlled substances 
falls below both of the thresholds in paragraph (a) of this section.
    (c) The reporting requirements of this section apply to every 
pharmacy that, at any time during a calendar month, holds a modified 
registration authorizing it to operate as an online pharmacy, regardless 
of whether the online pharmacy dispenses any controlled substances by 
means of the Internet during the month.
    (d) Reports will be submitted to DEA electronically via online 
reporting, electronic file upload, or other means as approved by DEA.
    (e) Reports shall be filed every month not later than the fifteenth 
day of the month succeeding the month for which they are submitted.
    (f) An online pharmacy filing a report under paragraph (a) of this 
section shall utilize the National Drug Code number assigned to the 
product under the National Drug Code System of the Food and Drug 
Administration, and indicate the total number of dosage units dispensed 
for each such National Drug Code number.
    (g) Records required to be kept under this section must be kept by 
the registrant for at least two years from the date of such records. The 
information shall be readily retrievable from the ordinary business 
records of the registrant and available for inspection and copying by 
authorized employees of the Administration.

[74 FR 15623, Apr. 6, 2009]



PART 1305_ORDERS FOR SCHEDULE I AND II CONTROLLED SUBSTANCES--Table of
Contents



                     Subpart A_General Requirements

Sec.
1305.01 Scope of part 1305.
1305.02 Definitions.
1305.03 Distributions requiring a Form 222 or digitally signed 
          electronic order.
1305.04 Persons entitled to order Schedule I and II controlled 
          substances.
1305.05 Power of attorney.
1305.06 Persons entitled to fill orders for Schedule I and II controlled 
          substances.
1305.07 Special procedure for filling certain orders.

                         Subpart B_DEA Form 222

1305.11 Procedure for obtaining DEA Forms 222.
1305.12 Procedure for executing DEA Forms 222.
1305.13 Procedure for filling DEA Forms 222.
1305.14 Procedure for endorsing DEA Forms 222.
1305.15 Unaccepted and defective DEA Forms 222.
1305.16 Lost and stolen DEA Forms 222.
1305.17 Preservation of DEA Forms 222.
1305.18 Return of unused DEA Forms 222.
1305.19 Cancellation and voiding of DEA Forms 222.

                       Subpart C_Electronic Orders

1305.21 Requirements for electronic orders.
1305.22 Procedure for filling electronic orders.
1305.23 Endorsing electronic orders.
1305.24 Central processing of orders.
1305.25 Unaccepted and defective electronic orders.
1305.26 Lost electronic orders.
1305.27 Preservation of electronic orders.
1305.28 Canceling and voiding electronic orders.
1305.29 Reporting to DEA.

    Authority: 21 U.S.C. 821, 828, 871(b), unless otherwise noted.

    Source: 70 FR 16911, Apr. 1, 2005, unless otherwise noted.



                     Subpart A_General Requirements



Sec. 1305.01  Scope of part 1305.

    Procedures governing the issuance, use, and preservation of orders 
for Schedule I and II controlled substances are set forth generally by 
section 308 of the Act (21 U.S.C. 828) and specifically by the sections 
of this part.

[[Page 83]]



Sec. 1305.02  Definitions.

    Any term contained in this part shall have the definition set forth 
in the Act or part 1300 of this chapter.



Sec. 1305.03  Distributions requiring a Form 222 or a digitally signed
electronic order.

    Either a DEA Form 222 or its electronic equivalent as set forth in 
subpart C of this part and Part 1311 of this chapter is required for 
each distribution of a Schedule I or II controlled substance except for 
the following:
    (a) Distributions to persons exempted from registration under Part 
1301 of this chapter.
    (b) Exports from the United States that conform with the 
requirements of the Act.
    (c) Deliveries to a registered analytical laboratory or its agent 
approved by DEA.
    (d) Delivery from a central fill pharmacy, as defined in Sec. 
1300.01 of this chapter, to a retail pharmacy.

[70 FR 16911, Apr. 1, 2005, as amended at 77 FR 4235, Jan. 27, 2012]



Sec. 1305.04  Persons entitled to order Schedule I and II controlled 
substances.

    (a) Only persons who are registered with DEA under section 303 of 
the Act (21 U.S.C. 823) to handle Schedule I or II controlled 
substances, and persons who are registered with DEA under section 1008 
of the Act (21 U.S.C. 958) to export these substances may obtain and use 
DEA Form 222 (order forms) or issue electronic orders for these 
substances. Persons not registered to handle Schedule I or II controlled 
substances and persons registered only to import controlled substances 
are not entitled to obtain Form 222 or issue electronic orders for these 
substances.
    (b) An order for Schedule I or II controlled substances may be 
executed only on behalf of the registrant named on the order and only if 
his or her registration for the substances being purchased has not 
expired or been revoked or suspended.



Sec. 1305.05  Power of attorney.

    (a) A registrant may authorize one or more individuals, whether or 
not located at his or her registered location, to issue orders for 
Schedule I and II controlled substances on the registrant's behalf by 
executing a power of attorney for each such individual, if the power of 
attorney is retained in the files, with executed Forms 222 where 
applicable, for the same period as any order bearing the signature of 
the attorney. The power of attorney must be available for inspection 
together with other order records.
    (b) A registrant may revoke any power of attorney at any time by 
executing a notice of revocation.
    (c) The power of attorney and notice of revocation must be similar 
to the following format:

        Power of Attorney for DEA Forms 222 and Electronic Orders

________________________________________________________________________
(Name of registrant)

________________________________________________________________________
(Address of registrant)

________________________________________________________________________
(DEA registration number)

    I, -------- (name of person granting power), the undersigned, who am 
authorized to sign the current application for registration of the 
above-named registrant under the Controlled Substances Act or Controlled 
Substances Import and Export Act, have made, constituted, and appointed, 
and by these presents, do make, constitute, and appoint -------- (name 
of attorney-in-fact), my true and lawful attorney for me in my name, 
place, and stead, to execute applications for Forms 222 and to sign 
orders for Schedule I and II controlled substances, whether these orders 
be on Form 222 or electronic, in accordance with 21 U.S.C. 828 and Part 
1305 of Title 21 of the Code of Federal Regulations. I hereby ratify and 
confirm all that said attorney must lawfully do or cause to be done by 
virtue hereof.
________________________________________________________________________
(Signature of person granting power)


I, -------- (name of attorney-in-fact), hereby affirm that I am the 
person named herein as attorney-in-fact and that the signature affixed 
hereto is my signature.

(signature of attorney-in-fact)


Witnesses:

    1. ------------


[[Page 84]]


    2. ------------


Signed and dated on the -------- day of --------, (year), at -------- .

                          Notice of Revocation

    The foregoing power of attorney is hereby revoked by the 
undersigned, who is authorized to sign the current application for 
registration of the above-named registrant under the Controlled 
Substances Act or the Controlled Substances Import and Export Act. 
Written notice of this revocation has been given to the attorney-in-fact 
-------- this same day.
________________________________________________________________________
(Signature of person revoking power)

Witnesses:

    1. ------------

    2. ------------

Signed and dated on the -------- day of --------, (year), at --------.

    (d) A power of attorney must be executed by the person who signed 
the most recent application for DEA registration or reregistration; the 
person to whom the power of attorney is being granted; and two 
witnesses.
    (e) A power of attorney must be revoked by the person who signed the 
most recent application for DEA registration or reregistration, and two 
witnesses.



Sec. 1305.06  Persons entitled to fill orders for Schedule I and II
controlled substances.

    An order for Schedule I and II controlled substances, whether on a 
DEA Form 222 or an electronic order, may be filled only by a person 
registered with DEA as a manufacturer or distributor of controlled 
substances listed in Schedule I or II pursuant to section 303 of the Act 
(21 U.S.C. 823) or as an importer of such substances pursuant to section 
1008 of the Act (21 U.S.C. 958), except for the following:
    (a) A person registered with DEA to dispense the substances, or to 
export the substances, if he/she is discontinuing business or if his/her 
registration is expiring without reregistration, may dispose of any 
Schedule I or II controlled substances in his/her possession with a DEA 
Form 222 or an electronic order in accordance with Sec. 1301.52 of this 
chapter.
    (b) A purchaser who has obtained any Schedule I or II controlled 
substance by either a DEA Form 222 or an electronic order may return the 
substance to the supplier of the substance with either a DEA Form 222 or 
an electronic order from the supplier.
    (c) A person registered to dispense Schedule II substances may 
distribute the substances to another dispenser with either a DEA Form 
222 or an electronic order only in the circumstances described in Sec. 
1307.11 of this chapter.
    (d) A person registered or authorized to conduct chemical analysis 
or research with controlled substances may distribute a Schedule I or II 
controlled substance to another person registered or authorized to 
conduct chemical analysis, instructional activities, or research with 
the substances with either a DEA Form 222 or an electronic order, if the 
distribution is for the purpose of furthering the chemical analysis, 
instructional activities, or research.
    (e) A person registered as a compounder of narcotic substances for 
use at off-site locations in conjunction with a narcotic treatment 
program at the compounding location, who is authorized to handle 
Schedule II narcotics, is authorized to fill either a DEA Form 222 or an 
electronic order for distribution of narcotic drugs to off-site narcotic 
treatment programs only.



Sec. 1305.07  Special procedure for filling certain orders.

    A supplier of carfentanil, etorphine hydrochloride, or 
diprenorphine, if he or she determines that the purchaser is a 
veterinarian engaged in zoo and exotic animal practice, wildlife 
management programs, or research, and is authorized by the Administrator 
to handle these substances, may fill the order in accordance with the 
procedures set forth in Sec. 1305.17 except that:
    (a) A DEA Form 222 or an electronic order for carfentanil, etorphine 
hydrochloride, and diprenorphine must contain only these substances in 
reasonable quantities.
    (b) The substances must be shipped, under secure conditions using 
substantial packaging material with no markings on the outside that 
would indicate

[[Page 85]]

the content, only to the purchaser's registered location.



                         Subpart B_DEA Form 222



Sec. 1305.11  Procedure for obtaining DEA Forms 222.

    (a) DEA Forms 222 are issued in mailing envelopes containing either 
seven or fourteen forms, each form containing an original, duplicate, 
and triplicate copy (respectively, Copy 1, Copy 2, and Copy 3). A limit, 
which is based on the business activity of the registrant, will be 
imposed on the number of DEA Forms 222, which will be furnished on any 
requisition unless additional forms are specifically requested and a 
reasonable need for such additional forms is shown.
    (b) Any person applying for a registration that would entitle him or 
her to obtain a DEA Form 222 may requisition the forms by so indicating 
on the application form; a DEA Form 222 will be supplied upon the 
registration of the applicant. Any person holding a registration 
entitling him or her to obtain a DEA Form 222 may requisition the forms 
for the first time by contacting any Division Office or the Registration 
Section of the Administration. Any person already holding a DEA Form 222 
may requisition additional forms on DEA Form 222a, which is mailed to a 
registrant approximately 30 days after each shipment of DEA Forms 222 to 
that registrant, or by contacting any Division Office or the 
Registration Section of the Administration. All requisition forms (DEA 
Form 222a) must be submitted to the DEA Registration Section.
    (c) Each requisition must show the name, address, and registration 
number of the registrant and the number of books of DEA Forms 222 
desired. Each requisition must be signed and dated by the same person 
who signed the most recent application for registration or for 
reregistration, or by any person authorized to obtain and execute DEA 
Forms 222 by a power of attorney under Sec. 1305.05.
    (d) DEA Forms 222 will be serially numbered and issued with the 
name, address, and registration number of the registrant, the authorized 
activity, and schedules of the registrant. This information cannot be 
altered or changed by the registrant; any errors must be corrected by 
the Registration Section of the Administration by returning the forms 
with notification of the error.



Sec. 1305.12  Procedure for executing DEA Forms 222.

    (a) A purchaser must prepare and execute a DEA Form 222 
simultaneously in triplicate by means of interleaved carbon sheets that 
are part of the DEA Form 222. DEA Form 222 must be prepared by use of a 
typewriter, pen, or indelible pencil.
    (b) Only one item may be entered on each numbered line. An item must 
consist of one or more commercial or bulk containers of the same 
finished or bulk form and quantity of the same substance. The number of 
lines completed must be noted on that form at the bottom of the form, in 
the space provided. DEA Forms 222 for carfentanil, etorphine 
hydrochloride, and diprenorphine must contain only these substances.
    (c) The name and address of the supplier from whom the controlled 
substances are being ordered must be entered on the form. Only one 
supplier may be listed on any form.
    (d) Each DEA Form 222 must be signed and dated by a person 
authorized to sign an application for registration or a person granted 
power of attorney to sign a Form 222 under Sec. 1305.05. The name of 
the purchaser, if different from the individual signing the DEA Form 
222, must also be inserted in the signature space.
    (e) Unexecuted DEA Forms 222 may be kept and may be executed at a 
location other than the registered location printed on the form, 
provided that all unexecuted forms are delivered promptly to the 
registered location upon an inspection of the location by any officer 
authorized to make inspections, or to enforce, any Federal, State, or 
local law regarding controlled substances.



Sec. 1305.13  Procedure for filling DEA Forms 222.

    (a) A purchaser must submit Copy 1 and Copy 2 of the DEA Form 222 to 
the supplier and retain Copy 3 in the purchaser's files.

[[Page 86]]

    (b) A supplier may fill the order, if possible and if the supplier 
desires to do so, and must record on Copies 1 and 2 the number of 
commercial or bulk containers furnished on each item and the date on 
which the containers are shipped to the purchaser. If an order cannot be 
filled in its entirety, it may be filled in part and the balance 
supplied by additional shipments within 60 days following the date of 
the DEA Form 222. No DEA Form 222 is valid more than 60 days after its 
execution by the purchaser, except as specified in paragraph (f) of this 
section.
    (c) The controlled substances must be shipped only to the purchaser 
and the location printed by the Administration on the DEA Form 222, 
except as specified in paragraph (f) of this section.
    (d) The supplier must retain Copy 1 of the DEA Form 222 for his or 
her files and forward Copy 2 to the Special Agent in Charge of the Drug 
Enforcement Administration in the area in which the supplier is located. 
Copy 2 must be forwarded at the close of the month during which the 
order is filled. If an order is filled by partial shipments, Copy 2 must 
be forwarded at the close of the month during which the final shipment 
is made or the 60-day validity period expires.
    (e) The purchaser must record on Copy 3 of the DEA Form 222 the 
number of commercial or bulk containers furnished on each item and the 
dates on which the containers are received by the purchaser.
    (f) DEA Forms 222 submitted by registered procurement officers of 
the Defense Supply Center of the Defense Logistics Agency for delivery 
to armed services establishments within the United States may be shipped 
to locations other than the location printed on the DEA Form 222, and in 
partial shipments at different times not to exceed six months from the 
date of the order, as designated by the procurement officer when 
submitting the order.



Sec. 1305.14  Procedure for endorsing DEA Forms 222.

    (a) A DEA Form 222, made out to any supplier who cannot fill all or 
a part of the order within the time limitation set forth in Sec. 
1305.13, may be endorsed to another supplier for filling. The 
endorsement must be made only by the supplier to whom the DEA Form 222 
was first made, must state (in the spaces provided on the reverse sides 
of Copies 1 and 2 of the DEA Form 222) the name and address of the 
second supplier, and must be signed by a person authorized to obtain and 
execute DEA Forms 222 on behalf of the first supplier. The first 
supplier may not fill any part of an order on an endorsed form. The 
second supplier may fill the order, if possible and if the supplier 
desires to do so, in accordance with Sec. 1305.13(b), (c), and (d), 
including shipping all substances directly to the purchaser.
    (b) Distributions made on endorsed DEA Forms 222 must be reported by 
the second supplier in the same manner as all other distributions except 
that where the name of the supplier is requested on the reporting form, 
the second supplier must record the name, address, and registration 
number of the first supplier.



Sec. 1305.15  Unaccepted and defective DEA Forms 222.

    (a) A DEA Form 222 must not be filled if either of the following 
apply:
    (1) The order is not complete, legible, or properly prepared, 
executed, or endorsed.
    (2) The order shows any alteration, erasure, or change of any 
description.
    (b) If a DEA Form 222 cannot be filled for any reason under this 
section, the supplier must return Copies 1 and 2 to the purchaser with a 
statement as to the reason (e.g., illegible or altered).
    (c) A supplier may for any reason refuse to accept any order and if 
a supplier refuses to accept the order, a statement that the order is 
not accepted is sufficient for purposes of this paragraph.
    (d) When a purchaser receives an unaccepted order, Copies 1 and 2 of 
the DEA Form 222 and the statement must be attached to Copy 3 and 
retained in the files of the purchaser in accordance with Sec. 1305.17. 
A defective DEA Form 222 may not be corrected; it must be replaced by a 
new DEA Form 222 for the order to be filled.

[[Page 87]]



Sec. 1305.16  Lost and stolen DEA Forms 222.

    (a) If a purchaser ascertains that an unfilled DEA Form 222 has been 
lost, he or she must execute another in triplicate and attach a 
statement containing the serial number and date of the lost form, and 
stating that the goods covered by the first DEA Form 222 were not 
received through loss of that DEA Form 222. Copy 3 of the second form 
and a copy of the statement must be retained with Copy 3 of the DEA Form 
222 first executed. A copy of the statement must be attached to Copies 1 
and 2 of the second DEA Form 222 sent to the supplier. If the first DEA 
Form 222 is subsequently received by the supplier to whom it was 
directed, the supplier must mark upon the face ``Not accepted'' and 
return Copies 1 and 2 to the purchaser, who must attach it to Copy 3 and 
the statement.
    (b) Whenever any used or unused DEA Forms 222 are stolen or lost 
(other than in the course of transmission) by any purchaser or supplier, 
the purchaser or supplier must immediately upon discovery of the theft 
or loss, report the theft or loss to the Special Agent in Charge of the 
Drug Enforcement Administration in the Divisional Office responsible for 
the area in which the registrant is located, stating the serial number 
of each form stolen or lost.
    (c) If the theft or loss includes any original DEA Forms 222 
received from purchasers and the supplier is unable to state the serial 
numbers of the DEA Forms 222, the supplier must report the date or 
approximate date of receipt and the names and addresses of the 
purchasers.
    (d) If an entire book of DEA Forms 222 is lost or stolen, and the 
purchaser is unable to state the serial numbers of the DEA Forms 222 in 
the book, the purchaser must report, in lieu of the numbers of the forms 
contained in the book, the date or approximate date of issuance.
    (e) If any unused DEA Form 222 reported stolen or lost is 
subsequently recovered or found, the Special Agent in Charge of the Drug 
Enforcement Administration in the Divisional Office responsible for the 
area in which the registrant is located must immediately be notified.



Sec. 1305.17  Preservation of DEA Forms 222.

    (a) The purchaser must retain Copy 3 of each executed DEA Form 222 
and all copies of unaccepted or defective forms with each statement 
attached.
    (b) The supplier must retain Copy 1 of each DEA Form 222 that it has 
filled.
    (c) DEA Forms 222 must be maintained separately from all other 
records of the registrant. DEA Forms 222 are required to be kept 
available for inspection for a period of two years. If a purchaser has 
several registered locations, the purchaser must retain Copy 3 of the 
executed DEA Form 222 and any attached statements or other related 
documents (not including unexecuted DEA Forms 222, which may be kept 
elsewhere under Sec. 1305.12(e)), at the registered location printed on 
the DEA Form 222.
    (d) The supplier of carfentanil, etorphine hydrochloride, and 
diprenorphine must maintain DEA Forms 222 for these substances 
separately from all other DEA Forms 222 and records required to be 
maintained by the registrant.



Sec. 1305.18  Return of unused DEA Forms 222.

    If the registration of any purchaser terminates (because the 
purchaser dies, ceases legal existence, discontinues business or 
professional practice, or changes the name or address as shown on the 
purchaser's registration) or is suspended or revoked under Sec. 1301.36 
of this chapter for all Schedule I and II controlled substances for 
which the purchaser is registered, the purchaser must return all unused 
DEA Forms 222 to the nearest office of the Administration.



Sec. 1305.19  Cancellation and voiding of DEA Forms 222.

    (a) A purchaser may cancel part or all of an order on a DEA Form 222 
by notifying the supplier in writing of the cancellation. The supplier 
must indicate the cancellation on Copies 1 and 2 of the DEA Form 222 by 
drawing a line

[[Page 88]]

through the canceled items and printing ``canceled'' in the space 
provided for number of items shipped.
    (b) A supplier may void part or all of an order on a DEA Form 222 by 
notifying the purchaser in writing of the voiding. The supplier must 
indicate the voiding in the manner prescribed for cancellation in 
paragraph (a) of this section.



                       Subpart C_Electronic Orders



Sec. 1305.21  Requirements for electronic orders.

    (a) To be valid, the purchaser must sign an electronic order for a 
Schedule I or II controlled substance with a digital signature issued to 
the purchaser, or the purchaser's agent, by DEA as provided in part 1311 
of this chapter.
    (b) The following data fields must be included on an electronic 
order for Schedule I and II controlled substances:
    (1) A unique number the purchaser assigns to track the order. The 
number must be in the following 9-character format: the last two digits 
of the year, X, and six characters as selected by the purchaser.
    (2) The purchaser's DEA registration number.
    (3) The name of the supplier.
    (4) The complete address of the supplier (may be completed by either 
the purchaser or the supplier).
    (5) The supplier's DEA registration number (may be completed by 
either the purchaser or the supplier).
    (6) The date the order is signed.
    (7) The name (including strength where appropriate) of the 
controlled substance product or the National Drug Code (NDC) number (the 
NDC number may be completed by either the purchaser or the supplier).
    (8) The quantity in a single package or container.
    (9) The number of packages or containers of each item ordered.
    (c) An electronic order may include controlled substances that are 
not in schedules I and II and non-controlled substances.



Sec. 1305.22  Procedure for filling electronic orders.

    (a) A purchaser must submit the order to a specific supplier. The 
supplier may initially process the order (e.g., entry of the order into 
the computer system, billing functions, inventory identification, etc.) 
centrally at any location, regardless of the location's registration 
with DEA. Following centralized processing, the supplier may distribute 
the order to one or more registered locations maintained by the supplier 
for filling. The registrant must maintain control of the processing of 
the order at all times.
    (b) A supplier may fill the order for a Schedule I or II controlled 
substance, if possible and if the supplier desires to do so and is 
authorized to do so under Sec. 1305.06.
    (c) A supplier must do the following before filling the order:
    (1) Verify the integrity of the signature and the order by using 
software that complies with Part 1311 of this chapter to validate the 
order.
    (2) Verify that the digital certificate has not expired.
    (3) Check the validity of the certificate holder's certificate by 
checking the Certificate Revocation List. The supplier may cache the 
Certificate Revocation List until it expires.
    (4) Verify the registrant's eligibility to order the controlled 
substances by checking the certificate extension data.
    (d) The supplier must retain an electronic record of every order, 
and, linked to each order, a record of the number of commercial or bulk 
containers furnished on each item and the date on which the supplier 
shipped the containers to the purchaser. The linked record must also 
include any data on the original order that the supplier completes. 
Software used to handle digitally signed orders must comply with part 
1311 of this chapter.
    (e) If an order cannot be filled in its entirety, a supplier may 
fill it in part and supply the balance by additional shipments within 60 
days following the date of the order. No order is valid more than 60 
days after its execution by the purchaser, except as specified in 
paragraph (h) of this section.

[[Page 89]]

    (f) A supplier must ship the controlled substances to the registered 
location associated with the digital certificate used to sign the order, 
except as specified in paragraph (h) of this section.
    (g) When a purchaser receives a shipment, the purchaser must create 
a record of the quantity of each item received and the date received. 
The record must be electronically linked to the original order and 
archived.
    (h) Registered procurement officers of the Defense Supply Center of 
the Defense Logistics Agency may order controlled substances for 
delivery to armed services establishments within the United States. 
These orders may be shipped to locations other than the registered 
location, and in partial shipments at different times not to exceed six 
months from the date of the order, as designated by the procurement 
officer when submitting the order.



Sec. 1305.23  Endorsing electronic orders.

    A supplier may not endorse an electronic order to another supplier 
to fill.



Sec. 1305.24  Central processing of orders.

    (a) A supplier that has one or more registered locations and 
maintains a central processing computer system in which orders are 
stored may have one or more of the supplier's registered locations fill 
an electronic order if the supplier does the following:
    (1) Assigns each item on the order to a specific registered location 
for filling.
    (2) Creates a record linked to the central file noting both which 
items a location filled and the location identity.
    (3) Ensures that no item is filled by more than one location.
    (4) Maintains the original order with all linked records on the 
central computer system.
    (b) A company that has central processing of orders must assign 
responsibility for filling parts of orders only to registered locations 
that the company owns and operates.



Sec. 1305.25  Unaccepted and defective electronic orders.

    (a) No electronic order may be filled if:
    (1) The required data fields have not been completed.
    (2) The order is not signed using a digital certificate issued by 
DEA.
    (3) The digital certificate used had expired or had been revoked 
prior to signature.
    (4) The purchaser's public key will not validate the digital 
signature.
    (5) The validation of the order shows that the order is invalid for 
any reason.
    (b) If an order cannot be filled for any reason under this section, 
the supplier must notify the purchaser and provide a statement as to the 
reason (e.g., improperly prepared or altered). A supplier may, for any 
reason, refuse to accept any order, and if a supplier refuses to accept 
the order, a statement that the order is not accepted is sufficient for 
purposes of this paragraph.
    (c) When a purchaser receives an unaccepted electronic order from 
the supplier, the purchaser must electronically link the statement of 
nonacceptance to the original order. The original order and the 
statement must be retained in accordance with Sec. 1305.27.
    (d) Neither a purchaser nor a supplier may correct a defective 
order; the purchaser must issue a new order for the order to be filled.



Sec. 1305.26  Lost electronic orders.

    (a) If a purchaser determines that an unfilled electronic order has 
been lost before or after receipt, the purchaser must provide, to the 
supplier, a signed statement containing the unique tracking number and 
date of the lost order and stating that the goods covered by the first 
order were not received through loss of that order.
    (b) If the purchaser executes an order to replace the lost order, 
the purchaser must electronically link an electronic record of the 
second order and a copy of the statement with the record of the first 
order and retain them.
    (c) If the supplier to whom the order was directed subsequently 
receives the first order, the supplier must indicate that it is ``Not 
Accepted'' and return it to the purchaser. The purchaser must link the 
returned order to the record of that order and the statement.

[[Page 90]]



Sec. 1305.27  Preservation of electronic orders.

    (a) A purchaser must, for each order filled, retain the original 
signed order and all linked records for that order for two years. The 
purchaser must also retain all copies of each unaccepted or defective 
order and each linked statement.
    (b) A supplier must retain each original order filled and the linked 
records for two years.
    (c) If electronic order records are maintained on a central server, 
the records must be readily retrievable at the registered location.



Sec. 1305.28  Canceling and voiding electronic orders.

    (a) A supplier may void all or part of an electronic order by 
notifying the purchaser of the voiding. If the entire order is voided, 
the supplier must make an electronic copy of the order, indicate on the 
copy ``Void,'' and return it to the purchaser. The supplier is not 
required to retain a record of orders that are not filled.
    (b) The purchaser must retain an electronic copy of the voided 
order.
    (c) To partially void an order, the supplier must indicate in the 
linked record that nothing was shipped for each item voided.



Sec. 1305.29  Reporting to DEA.

    A supplier must, for each electronic order filled, forward either a 
copy of the electronic order or an electronic report of the order in a 
format that DEA specifies to DEA within two business days.



PART 1306_PRESCRIPTIONS--Table of Contents



                           General Information

Sec.
1306.01 Scope of part 1306.
1306.02 Definitions.
1306.03 Persons entitled to issue prescriptions.
1306.04 Purpose of issue of prescription.
1306.05 Manner of issuance of prescriptions.
1306.06 Persons entitled to fill prescriptions.
1306.07 Administering or dispensing of narcotic drugs.
1306.08 Electronic prescriptions.
1306.09 Prescription requirements for online pharmacies.

               Controlled Substances Listed in Schedule II

1306.11 Requirement of prescription.
1306.12 Refilling prescriptions; issuance of multiple prescriptions.
1306.13 Partial filling of prescriptions.
1306.14 Labeling of substances and filling of prescriptions.
1306.15 Provision of prescription information between retail pharmacies 
          and central fill pharmacies for prescriptions of Schedule II 
          controlled substances.

        Controlled Substances Listed in Schedules III, IV, and V

1306.21 Requirement of prescription.
1306.22 Refilling of prescriptions.
1306.23 Partial filling of prescriptions.
1306.24 Labeling of substances and filling of prescriptions.
1306.25 Transfer between pharmacies of prescription information for 
          Schedules III, IV, and V controlled substances for refill 
          purposes.
1306.26 Dispensing without prescription.
1306.27 Provision of prescription information between retail pharmacies 
          and central fill pharmacies for initial and refill 
          prescriptions of Schedule III, IV, or V controlled substances.

    Authority: 21 U.S.C. 821, 829, 831, 871(b), unless otherwise noted.

    Source: 36 FR 7799, Apr. 24, 1971; 36 FR 13386, July 21, 1971, 
unless otherwise noted. Redesignated at 38 FR 26609, Sept. 24, 1973.

                           General Information



Sec. 1306.01  Scope of part 1306.

    Rules governing the issuance, filling and filing of prescriptions 
pursuant to section 309 of the Act (21 U.S.C. 829) are set forth 
generally in that section and specifically by the sections of this part.



Sec. 1306.02  Definitions.

    Any term contained in this part shall have the definition set forth 
in section 102 of the Act (21 U.S.C. 802) or part 1300 of this chapter.

[62 FR 13964, Mar. 24, 1997]



Sec. 1306.03  Persons entitled to issue prescriptions.

    (a) A prescription for a controlled substance may be issued only by 
an individual practitioner who is:
    (1) Authorized to prescribe controlled substances by the 
jurisdiction in which he is licensed to practice his profession and

[[Page 91]]

    (2) Either registered or exempted from registration pursuant to 
Sec. Sec. 1301.22(c) and 1301.23 of this chapter.
    (b) A prescription issued by an individual practitioner may be 
communicated to a pharmacist by an employee or agent of the individual 
practitioner.

[36 FR 7799, Apr. 24, 1971, as amended at 36 FR 18732, Sept. 21, 1971. 
Redesignated at 38 FR 26609, Sept. 24, 1973, as amended at 62 FR 13966, 
Mar. 24, 1997]



Sec. 1306.04  Purpose of issue of prescription.

    (a) A prescription for a controlled substance to be effective must 
be issued for a legitimate medical purpose by an individual practitioner 
acting in the usual course of his professional practice. The 
responsibility for the proper prescribing and dispensing of controlled 
substances is upon the prescribing practitioner, but a corresponding 
responsibility rests with the pharmacist who fills the prescription. An 
order purporting to be a prescription issued not in the usual course of 
professional treatment or in legitimate and authorized research is not a 
prescription within the meaning and intent of section 309 of the Act (21 
U.S.C. 829) and the person knowingly filling such a purported 
prescription, as well as the person issuing it, shall be subject to the 
penalties provided for violations of the provisions of law relating to 
controlled substances.
    (b) A prescription may not be issued in order for an individual 
practitioner to obtain controlled substances for supplying the 
individual practitioner for the purpose of general dispensing to 
patients.
    (c) A prescription may not be issued for ``detoxification 
treatment'' or ``maintenance treatment,'' unless the prescription is for 
a Schedule III, IV, or V narcotic drug approved by the Food and Drug 
Administration specifically for use in maintenance or detoxification 
treatment and the practitioner is in compliance with requirements in 
Sec. 1301.28 of this chapter.

[36 FR 7799, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973, 
and amended at 39 FR 37986, Oct. 25, 1974; 70 FR 36343, June 23, 2005]



Sec. 1306.05  Manner of issuance of prescriptions.

    (a) All prescriptions for controlled substances shall be dated as 
of, and signed on, the day when issued and shall bear the full name and 
address of the patient, the drug name, strength, dosage form, quantity 
prescribed, directions for use, and the name, address and registration 
number of the practitioner.
    (b) A prescription for a Schedule III, IV, or V narcotic drug 
approved by FDA specifically for ``detoxification treatment'' or 
``maintenance treatment'' must include the identification number issued 
by the Administrator under Sec. 1301.28(d) of this chapter or a written 
notice stating that the practitioner is acting under the good faith 
exception of Sec. 1301.28(e) of this chapter.
    (c) Where a prescription is for gamma-hydroxybutyric acid, the 
practitioner shall note on the face of the prescription the medical need 
of the patient for the prescription.
    (d) A practitioner may sign a paper prescription in the same manner 
as he would sign a check or legal document (e.g., J.H. Smith or John H. 
Smith). Where an oral order is not permitted, paper prescriptions shall 
be written with ink or indelible pencil, typewriter, or printed on a 
computer printer and shall be manually signed by the practitioner. A 
computer-generated prescription that is printed out or faxed by the 
practitioner must be manually signed.
    (e) Electronic prescriptions shall be created and signed using an 
application that meets the requirements of part 1311 of this chapter.
    (f) A prescription may be prepared by the secretary or agent for the 
signature of a practitioner, but the prescribing practitioner is 
responsible in case the prescription does not conform in all essential 
respects to the law and regulations. A corresponding liability rests 
upon the pharmacist, including a pharmacist employed by a central fill 
pharmacy, who fills a prescription not prepared in the form prescribed 
by DEA regulations.
    (g) An individual practitioner exempted from registration under 
Sec. 1301.22(c) of this chapter shall include on all prescriptions 
issued by him the

[[Page 92]]

registration number of the hospital or other institution and the special 
internal code number assigned to him by the hospital or other 
institution as provided in Sec. 1301.22(c) of this chapter, in lieu of 
the registration number of the practitioner required by this section. 
Each paper prescription shall have the name of the practitioner stamped, 
typed, or handprinted on it, as well as the signature of the 
practitioner.
    (h) An official exempted from registration under Sec. 1301.23(a) of 
this chapter must include on all prescriptions issued by him his branch 
of service or agency (e.g., ``U.S. Army'' or ``Public Health Service'') 
and his service identification number, in lieu of the registration 
number of the practitioner required by this section. The service 
identification number for a Public Health Service employee is his Social 
Security identification number. Each paper prescription shall have the 
name of the officer stamped, typed, or handprinted on it, as well as the 
signature of the officer.

[75 FR 16307, Mar. 31, 2010]



Sec. 1306.06  Persons entitled to fill prescriptions.

    A prescription for a controlled substance may only be filled by a 
pharmacist, acting in the usual course of his professional practice and 
either registered individually or employed in a registered pharmacy, a 
registered central fill pharmacy, or registered institutional 
practitioner.

[68 FR 37410, June 24, 2003, as amended at 70 FR 36343, June 23, 2005]



Sec. 1306.07  Administering or dispensing of narcotic drugs.

    (a) A practitioner may administer or dispense directly (but not 
prescribe) a narcotic drug listed in any schedule to a narcotic 
dependant person for the purpose of maintenance or detoxification 
treatment if the practitioner meets both of the following conditions:
    (1) The practitioner is separately registered with DEA as a narcotic 
treatment program.
    (2) The practitioner is in compliance with DEA regulations regarding 
treatment qualifications, security, records, and unsupervised use of the 
drugs pursuant to the Act.
    (b) Nothing in this section shall prohibit a physician who is not 
specifically registered to conduct a narcotic treatment program from 
administering (but not prescribing) narcotic drugs to a person for the 
purpose of relieving acute withdrawal symptoms when necessary while 
arrangements are being made for referral for treatment. Not more than 
one day's medication may be administered to the person or for the 
person's use at one time. Such emergency treatment may be carried out 
for not more than three days and may not be renewed or extended.
    (c) This section is not intended to impose any limitations on a 
physician or authorized hospital staff to administer or dispense 
narcotic drugs in a hospital to maintain or detoxify a person as an 
incidental adjunct to medical or surgical treatment of conditions other 
than addiction, or to administer or dispense narcotic drugs to persons 
with intractable pain in which no relief or cure is possible or none has 
been found after reasonable efforts.
    (d) A practitioner may administer or dispense (including prescribe) 
any Schedule III, IV, or V narcotic drug approved by the Food and Drug 
Administration specifically for use in maintenance or detoxification 
treatment to a narcotic dependent person if the practitioner complies 
with the requirements of Sec. 1301.28 of this chapter.

[39 FR 37986, Oct. 25, 1974, as amended at 70 FR 36344, June 23, 2005]



Sec. 1306.08  Electronic prescriptions.

    (a) An individual practitioner may sign and transmit electronic 
prescriptions for controlled substances provided the practitioner meets 
all of the following requirements:
    (1) The practitioner must comply with all other requirements for 
issuing controlled substance prescriptions in this part;
    (2) The practitioner must use an application that meets the 
requirements of part 1311 of this chapter; and
    (3) The practitioner must comply with the requirements for 
practitioners in part 1311 of this chapter.
    (b) A pharmacy may fill an electronically transmitted prescription 
for a

[[Page 93]]

controlled substance provided the pharmacy complies with all other 
requirements for filling controlled substance prescriptions in this part 
and with the requirements of part 1311 of this chapter.
    (c) To annotate an electronic prescription, a pharmacist must 
include all of the information that this part requires in the 
prescription record.
    (d) If the content of any of the information required under Sec. 
1306.05 for a controlled substance prescription is altered during the 
transmission, the prescription is deemed to be invalid and the pharmacy 
may not dispense the controlled substance.

[75 FR 16307, Mar. 31, 2010]



Sec. 1306.09  Prescription requirements for online pharmacies.

    (a) No controlled substance that is a prescription drug may be 
delivered, distributed, or dispensed by means of the Internet without a 
valid prescription.
    (b) In accordance with the Act, it is unlawful for any person to 
knowingly or intentionally fill a prescription for a controlled 
substance that was issued in a manner that constitutes dispensing by 
means of the Internet unless such person is a pharmacist who is acting 
in the usual course of his professional practice and is acting on behalf 
of a pharmacy whose registration has been modified under sections 
1301.13 and 1301.19 of this chapter to authorize it to operate as an 
online pharmacy.
    (c) Any online pharmacy that participates in the transfer between 
pharmacies of prescription information must do so in accordance with the 
requirements of Sec. Sec. 1306.15 and 1306.25 of this part.

[74 FR 15624, Apr. 6, 2009]

               Controlled Substances Listed in Schedule II



Sec. 1306.11  Requirement of prescription.

    (a) A pharmacist may dispense directly a controlled substance listed 
in Schedule II that is a prescription drug as determined under section 
503 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 353(b)) only 
pursuant to a written prescription signed by the practitioner, except as 
provided in paragraph (d) of this section. A paper prescription for a 
Schedule II controlled substance may be transmitted by the practitioner 
or the practitioner's agent to a pharmacy via facsimile equipment, 
provided that the original manually signed prescription is presented to 
the pharmacist for review prior to the actual dispensing of the 
controlled substance, except as noted in paragraph (e), (f), or (g) of 
this section. The original prescription shall be maintained in 
accordance with Sec. 1304.04(h) of this chapter.
    (b) An individual practitioner may administer or dispense directly a 
controlled substance listed in Schedule II in the course of his 
professional practice without a prescription, subject to Sec. 1306.07.
    (c) An institutional practitioner may administer or dispense 
directly (but not prescribe) a controlled substance listed in Schedule 
II only pursuant to a written prescription signed by the prescribing 
individual practitioner or to an order for medication made by an 
individual practitioner that is dispensed for immediate administration 
to the ultimate user.
    (d) In the case of an emergency situation, as defined by the 
Secretary in Sec. 290.10 of this title, a pharmacist may dispense a 
controlled substance listed in Schedule II upon receiving oral 
authorization of a prescribing individual practitioner, provided that:
    (1) The quantity prescribed and dispensed is limited to the amount 
adequate to treat the patient during the emergency period (dispensing 
beyond the emergency period must be pursuant to a paper or electronic 
prescription signed by the prescribing individual practitioner);
    (2) The prescription shall be immediately reduced to writing by the 
pharmacist and shall contain all information required in Sec. 1306.05, 
except for the signature of the prescribing individual practitioner;
    (3) If the prescribing individual practitioner is not known to the 
pharmacist, he must make a reasonable effort to determine that the oral 
authorization came from a registered individual practitioner, which may 
include a callback to the prescribing individual

[[Page 94]]

practitioner using his phone number as listed in the telephone directory 
and/or other good faith efforts to insure his identity; and
    (4) Within 7 days after authorizing an emergency oral prescription, 
the prescribing individual practitioner shall cause a written 
prescription for the emergency quantity prescribed to be delivered to 
the dispensing pharmacist. In addition to conforming to the requirements 
of Sec. 1306.05, the prescription shall have written on its face 
``Authorization for Emergency Dispensing,'' and the date of the oral 
order. The paper prescription may be delivered to the pharmacist in 
person or by mail, but if delivered by mail it must be postmarked within 
the 7-day period. Upon receipt, the dispensing pharmacist must attach 
this paper prescription to the oral emergency prescription that had 
earlier been reduced to writing. For electronic prescriptions, the 
pharmacist must annotate the record of the electronic prescription with 
the original authorization and date of the oral order. The pharmacist 
must notify the nearest office of the Administration if the prescribing 
individual practitioner fails to deliver a written prescription to him; 
failure of the pharmacist to do so shall void the authority conferred by 
this paragraph to dispense without a written prescription of a 
prescribing individual practitioner.
    (5) Central fill pharmacies shall not be authorized under this 
paragraph to prepare prescriptions for a controlled substance listed in 
Schedule II upon receiving an oral authorization from a retail 
pharmacist or an individual practitioner.
    (e) A prescription prepared in accordance with Sec. 1306.05 written 
for a Schedule II narcotic substance to be compounded for the direct 
administration to a patient by parenteral, intravenous, intramuscular, 
subcutaneous or intraspinal infusion may be transmitted by the 
practitioner or the practitioner's agent to the pharmacy by facsimile. 
The facsimile serves as the original written prescription for purposes 
of this paragraph (e) and it shall be maintained in accordance with 
Sec. 1304.04(h) of this chapter.
    (f) A prescription prepared in accordance with Sec. 1306.05 written 
for Schedule II substance for a resident of a Long Term Care Facility 
may be transmitted by the practitioner or the practitioner's agent to 
the dispensing pharmacy by facsimile. The facsimile serves as the 
original written prescription for purposes of this paragraph (f) and it 
shall be maintained in accordance with Sec. 1304.04(h).
    (g) A prescription prepared in accordance with Sec. 1306.05 written 
for a Schedule II narcotic substance for a patient enrolled in a hospice 
care program certified and/or paid for by Medicare under Title XVIII or 
a hospice program which is licensed by the state may be transmitted by 
the practitioner or the practitioner's agent to the dispensing pharmacy 
by facsimile. The practitioner or the practitioner's agent will note on 
the prescription that the patient is a hospice patient. The facsimile 
serves as the original written prescription for purposes of this 
paragraph (g) and it shall be maintained in accordance with Sec. 
1304.04(h).

[36 FR 7799, Apr. 24, 1971, as amended at 36 FR 18733, Sept. 21, 1971. 
Redesignated at 38 FR 26609, Sept. 24, 1973 and amended at 53 FR 4964, 
Feb. 19, 1988; 59 FR 26111, May 19, 1994; 59 FR 30832, June 15, 1994; 62 
FR 13964, Mar. 24, 1997; 65 FR 45713, July 25, 2000; 68 FR 37410, June 
24, 2003; 75 FR 16307, Mar. 31, 2010]



Sec. 1306.12  Refilling prescriptions; issuance of multiple 
prescriptions.

    (a) The refilling of a prescription for a controlled substance 
listed in Schedule II is prohibited.
    (b)(1) An individual practitioner may issue multiple prescriptions 
authorizing the patient to receive a total of up to a 90-day supply of a 
Schedule II controlled substance provided the following conditions are 
met:
    (i) Each separate prescription is issued for a legitimate medical 
purpose by an individual practitioner acting in the usual course of 
professional practice;
    (ii) The individual practitioner provides written instructions on 
each prescription (other than the first prescription, if the prescribing 
practitioner intends for that prescription to be filled immediately) 
indicating the earliest date on which a pharmacy may fill each 
prescription;

[[Page 95]]

    (iii) The individual practitioner concludes that providing the 
patient with multiple prescriptions in this manner does not create an 
undue risk of diversion or abuse;
    (iv) The issuance of multiple prescriptions as described in this 
section is permissible under the applicable state laws; and
    (v) The individual practitioner complies fully with all other 
applicable requirements under the Act and these regulations as well as 
any additional requirements under state law.
    (2) Nothing in this paragraph (b) shall be construed as mandating or 
encouraging individual practitioners to issue multiple prescriptions or 
to see their patients only once every 90 days when prescribing Schedule 
II controlled substances. Rather, individual practitioners must 
determine on their own, based on sound medical judgment, and in 
accordance with established medical standards, whether it is appropriate 
to issue multiple prescriptions and how often to see their patients when 
doing so.

[72 FR 64929, Nov. 19, 2007]



Sec. 1306.13  Partial filling of prescriptions.

    (a) The partial filling of a prescription for a controlled substance 
listed in Schedule II is permissible if the pharmacist is unable to 
supply the full quantity called for in a written or emergency oral 
prescription and he makes a notation of the quantity supplied on the 
face of the written prescription, written record of the emergency oral 
prescription, or in the electronic prescription record. The remaining 
portion of the prescription may be filled within 72 hours of the first 
partial filling; however, if the remaining portion is not or cannot be 
filled within the 72-hour period, the pharmacist shall notify the 
prescribing individual practitioner. No further quantity may be supplied 
beyond 72 hours without a new prescription.
    (b) A prescription for a Schedule II controlled substance written 
for a patient in a Long Term Care Facility (LTCF) or for a patient with 
a medical diagnosis documenting a terminal illness may be filled in 
partial quantities to include individual dosage units. If there is any 
question whether a patient may be classified as having a terminal 
illness, the pharmacist must contact the practitioner prior to partially 
filling the prescription. Both the pharmacist and the prescribing 
practitioner have a corresponding responsibility to assure that the 
controlled substance is for a terminally ill patient. The pharmacist 
must record on the prescription whether the patient is ``terminally 
ill'' or an ``LTCF patient.'' A prescription that is partially filled 
and does not contain the notation ``terminally ill'' or ``LTCF patient'' 
shall be deemed to have been filled in violation of the Act. For each 
partial filling, the dispensing pharmacist shall record on the back of 
the prescription (or on another appropriate record, uniformly 
maintained, and readily retrievable) the date of the partial filling, 
quantity dispensed, remaining quantity authorized to be dispensed, and 
the identification of the dispensing pharmacist. The total quantity of 
Schedule II controlled substances dispensed in all partial fillings must 
not exceed the total quantity prescribed. Schedule II prescriptions for 
patients in a LTCF or patients with a medical diagnosis documenting a 
terminal illness shall be valid for a period not to exceed 60 days from 
the issue date unless sooner terminated by the discontinuance of 
medication.
    (c) Information pertaining to current Schedule II prescriptions for 
patients in a LTCF or for patients with a medical diagnosis documenting 
a terminal illness may be maintained in a computerized system if this 
system has the capability to permit:
    (1) Output (display or printout) of the original prescription 
number, date of issue, identification of prescribing individual 
practitioner, identification of patient, address of the LTCF or address 
of the hospital or residence of the patient, identification of 
medication authorized (to include dosage, form, strength and quantity), 
listing of the partial fillings that have been dispensed under each 
prescription and the information required in Sec. 1306.13(b).
    (2) Immediate (real time) updating of the prescription record each 
time a partial filling of the prescription is conducted.

[[Page 96]]

    (3) Retrieval of partially filled Schedule II prescription 
information is the same as required by Sec. 1306.22(b) (4) and (5) for 
Schedule III and IV prescription refill information.

(Authority: 21 U.S.C. 801, et seq.)

[36 FR 7799, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973, 
and amended at 45 FR 54330, July 15, 1980; 56 FR 25027, June 3, 1991; 62 
FR 13965, Mar. 24, 1997; 75 FR 16308, Mar. 31, 2010]



Sec. 1306.14  Labeling of substances and filling of prescriptions.

    (a) The pharmacist filling a written or emergency oral prescription 
for a controlled substance listed in Schedule II shall affix to the 
package a label showing date of filling, the pharmacy name and address, 
the serial number of the prescription, the name of the patient, the name 
of the prescribing practitioner, and directions for use and cautionary 
statements, if any, contained in such prescription or required by law.
    (b) If the prescription is filled at a central fill pharmacy, the 
central fill pharmacy shall affix to the package a label showing the 
retail pharmacy name and address and a unique identifier, (i.e. the 
central fill pharmacy's DEA registration number) indicating that the 
prescription was filled at the central fill pharmacy, in addition to the 
information required under paragraph (a) of this section.
    (c) The requirements of paragraph (a) of this section do not apply 
when a controlled substance listed in Schedule II is prescribed for 
administration to an ultimate user who is institutionalized: Provided, 
That:
    (1) Not more than 7-day supply of the controlled substance listed in 
Schedule II is dispensed at one time;
    (2) The controlled substance listed in Schedule II is not in the 
possession of the ultimate user prior to the administration;
    (3) The institution maintains appropriate safeguards and records 
regarding the proper administration, control, dispensing, and storage of 
the controlled substance listed in Schedule II; and
    (4) The system employed by the pharmacist in filling a prescription 
is adequate to identify the supplier, the product, and the patient, and 
to set forth the directions for use and cautionary statements, if any, 
contained in the prescription or required by law.
    (d) All written prescriptions and written records of emergency oral 
prescriptions shall be kept in accordance with requirements of Sec. 
1304.04(h) of this chapter.
    (e) Where a prescription that has been prepared in accordance with 
section 1306.12(b) contains instructions from the prescribing 
practitioner indicating that the prescription shall not be filled until 
a certain date, no pharmacist may fill the prescription before that 
date.

[36 FR 13368, July 21, 1971, as amended at 37 FR 15921, Aug. 8, 1972. 
Redesignated at 38 FR 26609, Sept. 24, 1973, as amended at 62 FR 13965, 
Mar. 24, 1997; 68 FR 37410, June 24, 2003; 72 FR 64930, Nov. 19, 2007]



Sec. 1306.15  Provision of prescription information between retail 
pharmacies and central fill pharmacies for prescriptions of Schedule II

controlled substances.

    Prescription information may be provided to an authorized central 
fill pharmacy by a retail pharmacy for dispensing purposes. The 
following requirements shall also apply:
    (a) Prescriptions for controlled substances listed in Schedule II 
may be transmitted electronically from a retail pharmacy to a central 
fill pharmacy including via facsimile. The retail pharmacy transmitting 
the prescription information must:
    (1) Write the words ``CENTRAL FILL'' on the face of the original 
paper prescription and record the name, address, and DEA registration 
number of the central fill pharmacy to which the prescription has been 
transmitted, the name of the retail pharmacy pharmacist transmitting the 
prescription, and the date of transmittal. For electronic prescriptions 
the name, address, and DEA registration number of the central fill 
pharmacy to which the prescription has been transmitted, the name of the 
retail pharmacy pharmacist transmitting the prescription, and the date 
of transmittal must be added to the electronic prescription record.
    (2) Ensure that all information required to be on a prescription 
pursuant

[[Page 97]]

to Section 1306.05 of this part is transmitted to the central fill 
pharmacy (either on the face of the prescription or in the electronic 
transmission of information);
    (3) Maintain the original prescription for a period of two years 
from the date the prescription was filled;
    (4) Keep a record of receipt of the filled prescription, including 
the date of receipt, the method of delivery (private, common or contract 
carrier) and the name of the retail pharmacy employee accepting 
delivery.
    (b) The central fill pharmacy receiving the transmitted prescription 
must:
    (1) Keep a copy of the prescription (if sent via facsimile) or an 
electronic record of all the information transmitted by the retail 
pharmacy, including the name, address, and DEA registration number of 
the retail pharmacy transmitting the prescription;
    (2) Keep a record of the date of receipt of the transmitted 
prescription, the name of the pharmacist filling the prescription, and 
the date of filling of the prescription;
    (3) Keep a record of the date the filled prescription was delivered 
to the retail pharmacy and the method of delivery (i.e. private, common 
or contract carrier).

[68 FR 37410, June 24, 2003, as amended at 75 FR 16308, Mar. 31, 2010]

        Controlled Substances Listed in Schedules III, IV, and V



Sec. 1306.21  Requirement of prescription.

    (a) A pharmacist may dispense directly a controlled substance listed 
in Schedule III, IV, or V that is a prescription drug as determined 
under section 503(b) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 353(b)) only pursuant to either a paper prescription signed by a 
practitioner, a facsimile of a signed paper prescription transmitted by 
the practitioner or the practitioner's agent to the pharmacy, an 
electronic prescription that meets the requirements of this part and 
part 1311 of this chapter, or an oral prescription made by an individual 
practitioner and promptly reduced to writing by the pharmacist 
containing all information required in Sec. 1306.05, except for the 
signature of the practitioner.
    (b) An individual practitioner may administer or dispense directly a 
controlled substance listed in Schedule III, IV, or V in the course of 
his/her professional practice without a prescription, subject to Sec. 
1306.07.
    (c) An institutional practitioner may administer or dispense 
directly (but not prescribe) a controlled substance listed in Schedule 
III, IV, or V only pursuant to a paper prescription signed by an 
individual practitioner, a facsimile of a paper prescription or order 
for medication transmitted by the practitioner or the practitioner's 
agent to the institutional practitioner-pharmacist, an electronic 
prescription that meets the requirements of this part and part 1311 of 
this chapter, or an oral prescription made by an individual practitioner 
and promptly reduced to writing by the pharmacist (containing all 
information required in Sec. 1306.05 except for the signature of the 
individual practitioner), or pursuant to an order for medication made by 
an individual practitioner that is dispensed for immediate 
administration to the ultimate user, subject to Sec. 1306.07.

[62 FR 13965, Mar. 24, 1997, as amended at 75 FR 16308, Mar. 31, 2010]



Sec. 1306.22  Refilling of prescriptions.

    (a) No prescription for a controlled substance listed in Schedule 
III or IV shall be filled or refilled more than six months after the 
date on which such prescription was issued. No prescription for a 
controlled substance listed in Schedule III or IV authorized to be 
refilled may be refilled more than five times.
    (b) Each refilling of a prescription shall be entered on the back of 
the prescription or on another appropriate document or electronic 
prescription record. If entered on another document, such as a 
medication record, or electronic prescription record, the document or 
record must be uniformly maintained and readily retrievable.
    (c) The following information must be retrievable by the 
prescription number:
    (1) The name and dosage form of the controlled substance.
    (2) The date filled or refilled.
    (3) The quantity dispensed.

[[Page 98]]

    (4) The initials of the dispensing pharmacist for each refill.
    (5) The total number of refills for that prescription.
    (d) If the pharmacist merely initials and dates the back of the 
prescription or annotates the electronic prescription record, it shall 
be deemed that the full face amount of the prescription has been 
dispensed.
    (e) The prescribing practitioner may authorize additional refills of 
Schedule III or IV controlled substances on the original prescription 
through an oral refill authorization transmitted to the pharmacist 
provided the following conditions are met:
    (1) The total quantity authorized, including the amount of the 
original prescription, does not exceed five refills nor extend beyond 
six months from the date of issue of the original prescription.
    (2) The pharmacist obtaining the oral authorization records on the 
reverse of the original paper prescription or annotates the electronic 
prescription record with the date, quantity of refill, number of 
additional refills authorized, and initials the paper prescription or 
annotates the electronic prescription record showing who received the 
authorization from the prescribing practitioner who issued the original 
prescription.
    (3) The quantity of each additional refill authorized is equal to or 
less than the quantity authorized for the initial filling of the 
original prescription.
    (4) The prescribing practitioner must execute a new and separate 
prescription for any additional quantities beyond the five-refill, six-
month limitation.
    (f) As an alternative to the procedures provided by paragraphs (a) 
through (e) of this section, a computer application may be used for the 
storage and retrieval of refill information for original paper 
prescription orders for controlled substances in Schedule III and IV, 
subject to the following conditions:
    (1) Any such proposed computerized application must provide online 
retrieval (via computer monitor or hard-copy printout) of original 
prescription order information for those prescription orders that are 
currently authorized for refilling. This shall include, but is not 
limited to, data such as the original prescription number; date of 
issuance of the original prescription order by the practitioner; full 
name and address of the patient; name, address, and DEA registration 
number of the practitioner; and the name, strength, dosage form, 
quantity of the controlled substance prescribed (and quantity dispensed 
if different from the quantity prescribed), and the total number of 
refills authorized by the prescribing practitioner.
    (2) Any such proposed computerized application must also provide 
online retrieval (via computer monitor or hard-copy printout) of the 
current refill history for Schedule III or IV controlled substance 
prescription orders (those authorized for refill during the past six 
months). This refill history shall include, but is not limited to, the 
name of the controlled substance, the date of refill, the quantity 
dispensed, the identification code, or name or initials of the 
dispensing pharmacist for each refill and the total number of refills 
dispensed to date for that prescription order.
    (3) Documentation of the fact that the refill information entered 
into the computer each time a pharmacist refills an original paper, fax, 
or oral prescription order for a Schedule III or IV controlled substance 
is correct must be provided by the individual pharmacist who makes use 
of such an application. If such an application provides a hard-copy 
printout of each day's controlled substance prescription order refill 
data, that printout shall be verified, dated, and signed by the 
individual pharmacist who refilled such a prescription order. The 
individual pharmacist must verify that the data indicated are correct 
and then sign this document in the same manner as he would sign a check 
or legal document (e.g., J.H. Smith, or John H. Smith). This document 
shall be maintained in a separate file at that pharmacy for a period of 
two years from the dispensing date. This printout of the day's 
controlled substance prescription order refill data must be provided to 
each pharmacy using such a computerized application within 72 hours of 
the date on which the refill was dispensed. It must

[[Page 99]]

be verified and signed by each pharmacist who is involved with such 
dispensing. In lieu of such a printout, the pharmacy shall maintain a 
bound log book, or separate file, in which each individual pharmacist 
involved in such dispensing shall sign a statement (in the manner 
previously described) each day, attesting to the fact that the refill 
information entered into the computer that day has been reviewed by him 
and is correct as shown. Such a book or file must be maintained at the 
pharmacy employing such an application for a period of two years after 
the date of dispensing the appropriately authorized refill.
    (4) Any such computerized application shall have the capability of 
producing a printout of any refill data that the user pharmacy is 
responsible for maintaining under the Act and its implementing 
regulations. For example, this would include a refill-by-refill audit 
trail for any specified strength and dosage form of any controlled 
substance (by either brand or generic name or both). Such a printout 
must include name of the prescribing practitioner, name and address of 
the patient, quantity dispensed on each refill, date of dispensing for 
each refill, name or identification code of the dispensing pharmacist, 
and the number of the original prescription order. In any computerized 
application employed by a user pharmacy the central recordkeeping 
location must be capable of sending the printout to the pharmacy within 
48 hours, and if a DEA Special Agent or Diversion Investigator requests 
a copy of such printout from the user pharmacy, it must, if requested to 
do so by the Agent or Investigator, verify the printout transmittal 
capability of its application by documentation (e.g., postmark).
    (5) In the event that a pharmacy which employs such a computerized 
application experiences system down-time, the pharmacy must have an 
auxiliary procedure which will be used for documentation of refills of 
Schedule III and IV controlled substance prescription orders. This 
auxiliary procedure must ensure that refills are authorized by the 
original prescription order, that the maximum number of refills has not 
been exceeded, and that all of the appropriate data are retained for 
online data entry as soon as the computer system is available for use 
again.
    (g) When filing refill information for original paper, fax, or oral 
prescription orders for Schedule III or IV controlled substances, a 
pharmacy may use only one of the two applications described in 
paragraphs (a) through (e) or (f) of this section.
    (h) When filing refill information for electronic prescriptions, a 
pharmacy must use an application that meets the requirements of part 
1311 of this chapter.

[75 FR 16308, Mar. 31, 2010]



Sec. 1306.23  Partial filling of prescriptions.

    The partial filling of a prescription for a controlled substance 
listed in Schedule III, IV, or V is permissible, provided that:
    (a) Each partial filling is recorded in the same manner as a 
refilling,
    (b) The total quantity dispensed in all partial fillings does not 
exceed the total quantity prescribed, and
    (c) No dispensing occurs after 6 months after the date on which the 
prescription was issued.

[36 FR 18733, Sept. 21, 1971. Redesignated at 38 FR 26609, Sept. 24, 
1973, and amended at 51 FR 5320, Feb. 13, 1986; 62 FR 13965, Mar. 24, 
1997]



Sec. 1306.24  Labeling of substances and filling of prescriptions.

    (a) The pharmacist filling a prescription for a controlled substance 
listed in Schedule III, IV, or V shall affix to the package a label 
showing the pharmacy name and address, the serial number and date of 
initial filling, the name of the patient, the name of the practitioner 
issuing the prescription, and directions for use and cautionary 
statements, if any, contained in such prescription as required by law.
    (b) If the prescription is filled at a central fill pharmacy, the 
central fill pharmacy shall affix to the package a label showing the 
retail pharmacy name and address and a unique identifier, (i.e. the 
central fill pharmacy's DEA registration number) indicating that the 
prescription was filled at the central fill pharmacy, in addition to

[[Page 100]]

the information required under paragraph (a) of this section.
    (c) The requirements of paragraph (a) of this section do not apply 
when a controlled substance listed in Schedule III, IV, or V is 
prescribed for administration to an ultimate user who is 
institutionalized: Provided, That:
    (1) Not more than a 34-day supply or 100 dosage units, whichever is 
less, of the controlled substance listed in Schedule III, IV, or V is 
dispensed at one time;
    (2) The controlled substance listed in Schedule III, IV, or V is not 
in the possession of the ultimate user prior to administration;
    (3) The institution maintains appropriate safeguards and records the 
proper administration, control, dispensing, and storage of the 
controlled substance listed in Schedule III, IV, or V; and
    (4) The system employed by the pharmacist in filling a prescription 
is adequate to identify the supplier, the product and the patient, and 
to set forth the directions for use and cautionary statements, if any, 
contained in the prescription or required by law.
    (d) All prescriptions for controlled substances listed in Schedules 
III, IV, and V shall be kept in accordance with Sec. 1304.04(h) of this 
chapter.

[62 FR 13965, Mar. 24, 1997, as amended at 68 FR 37411, June 24, 2003]



Sec. 1306.25  Transfer between pharmacies of prescription information
for Schedules III, IV, and V controlled substances for refill purposes.

    (a) The transfer of original prescription information for a 
controlled substance listed in Schedule III, IV, or V for the purpose of 
refill dispensing is permissible between pharmacies on a one-time basis 
only. However, pharmacies electronically sharing a real-time, online 
database may transfer up to the maximum refills permitted by law and the 
prescriber's authorization.
    (b) Transfers are subject to the following requirements:
    (1) The transfer must be communicated directly between two licensed 
pharmacists.
    (2) The transferring pharmacist must do the following:
    (i) Write the word ``VOID'' on the face of the invalidated 
prescription; for electronic prescriptions, information that the 
prescription has been transferred must be added to the prescription 
record.
    (ii) Record on the reverse of the invalidated prescription the name, 
address, and DEA registration number of the pharmacy to which it was 
transferred and the name of the pharmacist receiving the prescription 
information; for electronic prescriptions, such information must be 
added to the prescription record.
    (iii) Record the date of the transfer and the name of the pharmacist 
transferring the information.
    (3) For paper prescriptions and prescriptions received orally and 
reduced to writing by the pharmacist pursuant to Sec. 1306.21(a), the 
pharmacist receiving the transferred prescription information must write 
the word ``transfer'' on the face of the transferred prescription and 
reduce to writing all information required to be on a prescription 
pursuant to Sec. 1306.05 and include:
    (i) Date of issuance of original prescription.
    (ii) Original number of refills authorized on original prescription.
    (iii) Date of original dispensing.
    (iv) Number of valid refills remaining and date(s) and locations of 
previous refill(s).
    (v) Pharmacy's name, address, DEA registration number, and 
prescription number from which the prescription information was 
transferred.
    (vi) Name of pharmacist who transferred the prescription.
    (vii) Pharmacy's name, address, DEA registration number, and 
prescription number from which the prescription was originally filled.
    (4) For electronic prescriptions being transferred electronically, 
the transferring pharmacist must provide the receiving pharmacist with 
the following information in addition to the original electronic 
prescription data:
    (i) The date of the original dispensing.
    (ii) The number of refills remaining and the date(s) and locations 
of previous refills.
    (iii) The transferring pharmacy's name, address, DEA registration 
number, and prescription number for each dispensing.

[[Page 101]]

    (iv) The name of the pharmacist transferring the prescription.
    (v) The name, address, DEA registration number, and prescription 
number from the pharmacy that originally filled the prescription, if 
different.
    (5) The pharmacist receiving a transferred electronic prescription 
must create an electronic record for the prescription that includes the 
receiving pharmacist's name and all of the information transferred with 
the prescription under paragraph (b)(4) of this section.
    (c) The original and transferred prescription(s) must be maintained 
for a period of two years from the date of last refill.
    (d) Pharmacies electronically accessing the same prescription record 
must satisfy all information requirements of a manual mode for 
prescription transferal.
    (e) The procedure allowing the transfer of prescription information 
for refill purposes is permissible only if allowable under existing 
State or other applicable law.

[75 FR 16309, Mar. 31, 2010]



Sec. 1306.26  Dispensing without prescription.

    A controlled substance listed in Schedules II, III, IV, or V which 
is not a prescription drug as determined under the Federal Food, Drug, 
and Cosmetic Act, may be dispensed by a pharmacist without a 
prescription to a purchaser at retail, provided that:
    (a) Such dispensing is made only by a pharmacist (as defined in part 
1300 of this chapter), and not by a nonpharmacist employee even if under 
the supervision of a pharmacist (although after the pharmacist has 
fulfilled his professional and legal responsibilities set forth in this 
section, the actual cash, credit transaction, or delivery, may be 
completed by a nonpharmacist);
    (b) Not more than 240 cc. (8 ounces) of any such controlled 
substance containing opium, nor more than 120 cc. (4 ounces) of any 
other such controlled substance nor more than 48 dosage units of any 
such controlled substance containing opium, nor more than 24 dosage 
units of any other such controlled substance may be dispensed at retail 
to the same purchaser in any given 48-hour period;
    (c) The purchaser is at least 18 years of age;
    (d) The pharmacist requires every purchaser of a controlled 
substance under this section not known to him to furnish suitable 
identification (including proof of age where appropriate);
    (e) A bound record book for dispensing of controlled substances 
under this section is maintained by the pharmacist, which book shall 
contain the name and address of the purchaser, the name and quantity of 
controlled substance purchased, the date of each purchase, and the name 
or initials of the pharmacist who dispensed the substance to the 
purchaser (the book shall be maintained in accordance with the 
recordkeeping requirement of Sec. 1304.04 of this chapter); and
    (f) A prescription is not required for distribution or dispensing of 
the substance pursuant to any other Federal, State or local law.
    (g) Central fill pharmacies may not dispense controlled substances 
to a purchaser at retail pursuant to this section.

[36 FR 7799, Apr. 24, 1971, as amended at 36 FR 18733, Sept. 21, 1971. 
Redesignated at 38 FR 26609, Sept. 24, 1973, and further redesignated 
and amended at 62 FR 13966, Mar. 24, 1997; 68 FR 37411, June 24, 2003]



Sec. 1306.27  Provision of prescription information between retail
pharmacies and central fill pharmacies for initial and refill 

prescriptions of Schedule III, IV, or V controlled substances.

    Prescription information may be provided to an authorized central 
fill pharmacy by a retail pharmacy for dispensing purposes. The 
following requirements shall also apply:
    (a) Prescriptions for controlled substances listed in Schedule III, 
IV or V may be transmitted electronically from a retail pharmacy to a 
central fill pharmacy including via facsimile. The retail pharmacy 
transmitting the prescription information must:
    (1) Write the word ``CENTRAL FILL'' on the face of the original 
prescription and record the name, address, and DEA registration number 
of the central fill pharmacy to which the prescription has been 
transmitted and the name of

[[Page 102]]

the retail pharmacy pharmacist transmitting the prescription, and the 
date of transmittal;
    (2) Ensure that all information required to be on a prescription 
pursuant to Sec. 1306.05 of this part is transmitted to the central 
fill pharmacy (either on the face of the prescription or in the 
electronic transmission of information);
    (3) Indicate in the information transmitted the number of refills 
already dispensed and the number of refills remaining;
    (4) Maintain the original prescription for a period of two years 
from the date the prescription was last refilled;
    (5) Keep a record of receipt of the filled prescription, including 
the date of receipt, the method of delivery (private, common or contract 
carrier) and the name of the retail pharmacy employee accepting 
delivery.
    (b) The central fill pharmacy receiving the transmitted prescription 
must:
    (1) Keep a copy of the prescription (if sent via facsimile) or an 
electronic record of all the information transmitted by the retail 
pharmacy, including the name, address, and DEA registration number of 
the retail pharmacy transmitting the prescription;
    (2) Keep a record of the date of receipt of the transmitted 
prescription, the name of the licensed pharmacist filling the 
prescription, and dates of filling or refilling of the prescription;
    (3) Keep a record of the date the filled prescription was delivered 
to the retail pharmacy and the method of delivery (i.e. private, common 
or contract carrier).

[68 FR 37411, June 24, 2003]



PART 1307_MISCELLANEOUS--Table of Contents



                           General Information

Sec.
1307.01 Definitions.
1307.02 Application of State law and other Federal law.
1307.03 Exceptions to regulations.

   Special Exceptions for Manufacture and Distribution of Controlled 
                               Substances

1307.11 Distribution by dispenser to another practitioner or reverse 
          distributor.
1307.12 Distribution to supplier or manufacturer.
1307.13 Incidental manufacture of controlled substances.

                    Disposal of Controlled Substances

1307.21 Procedure for disposing of controlled substances.
1307.22 Disposal of controlled substances by the Administration.

                         Special Exempt Persons

1307.31 Native American Church.

    Authority: 21 U.S.C. 821, 822(d), 871(b), unless otherwise noted.

    Source: 36 FR 7801, Apr. 24, 1971, unless otherwise noted. 
Redesignated at 38 FR 26609, Sept. 24, 1973.

                           General Information



Sec. 1307.01  Definitions.

    Any term contained in this part shall have the definition set forth 
in section 102 of the Act (21 U.S.C. 802) or part 1300 of this chapter.

[62 FR 13966, Mar. 24, 1997]



Sec. 1307.02  Application of State law and other Federal law.

    Nothing in this chapter shall be construed as authorizing or 
permitting any person to do any act which such person is not authorized 
or permitted to do under other Federal laws or obligations under 
international treaties, conventions or protocols, or under the law of 
the State in which he/she desires to do such act nor shall compliance 
with such parts be construed as compliance with other Federal or State 
laws unless expressly provided in such other laws.

[62 FR 13966, Mar. 24, 1997]



Sec. 1307.03  Exceptions to regulations.

    Any person may apply for an exception to the application of any 
provision of this chapter by filing a written request with the Office of 
Diversion Control, Drug Enforcement Administration, stating the reasons 
for such exception. See the Table of DEA Mailing Addresses in Sec. 
1321.01 of this chapter for the current mailing address. The 
Administrator may grant an exception in his discretion, but in no case 
shall he/she be required to grant an exception

[[Page 103]]

to any person which is otherwise required by law or the regulations 
cited in this section.

[75 FR 10678, Mar. 9, 2010]

   Special Exceptions for Manufacture and Distribution of Controlled 
                               Substances



Sec. 1307.11  Distribution by dispenser to another practitioner or 
reverse distributor.

    (a) A practitioner who is registered to dispense a controlled 
substance may distribute (without being registered to distribute) a 
quantity of such substance to--
    (1) Another practitioner for the purpose of general dispensing by 
the practitioner to patients, provided that--
    (i) The practitioner to whom the controlled substance is to be 
distributed is registered under the Act to dispense that controlled 
substance;
    (ii) The distribution is recorded by the distributing practitioner 
in accordance with Sec. 1304.22(c) of this chapter and by the receiving 
practitioner in accordance with Sec. 1304.22(c) of this chapter;
    (iii) If the substance is listed in Schedule I or II, an order form 
is used as required in part 1305 of this chapter; and
    (iv) The total number of dosage units of all controlled substances 
distributed by the practitioner pursuant to this section and Sec. 
1301.25 of this chapter during each calendar year in which the 
practitioner is registered to dispense does not exceed 5 percent of the 
total number of dosage units of all controlled substances distributed 
and dispensed by the practitioner during the same calendar year.
    (2) A reverse distributor who is registered to receive such 
controlled substances.
    (b) If, during any calendar year in which the practitioner is 
registered to dispense, the practitioner has reason to believe that the 
total number of dosage units of all controlled substances which will be 
distributed by him pursuant to paragraph (a)(1) of this section and 
Sec. 1301.25 of this chapter will exceed 5 percent of this total number 
of dosage units of all controlled substances distributed and dispensed 
by him during that calendar year, the practitioner shall obtain a 
registration to distribute controlled substances.
    (c) The distributions that a registered retail pharmacy makes to 
automated dispensing systems at long term care facilities for which the 
retail pharmacy also holds registrations do not count toward the 5 
percent limit in paragraphs (a)(1)(iv) and (b) of this section.

[68 FR 41229, July 11, 2003, as amended at 70 FR 25466, May 13, 2005]



Sec. 1307.12  Distribution to supplier or manufacturer.

    (a) Any person lawfully in possession of a controlled substance 
listed in any schedule may distribute (without being registered to 
distribute) that substance to the person from whom he/she obtained it or 
to the manufacturer of the substance, or, if designated, to the 
manufacturer's registered agent for accepting returns, provided that a 
written record is maintained which indicates the date of the 
transaction, the name, form and quantity of the substance, the name, 
address, and registration number, if any, of the person making the 
distribution, and the name, address, and registration number, if known, 
of the supplier or manufacturer. In the case of returning a controlled 
substance in Schedule I or II, an order form shall be used in the manner 
prescribed in part 1305 of this chapter and be maintained as the written 
record of the transaction. Any person not required to register pursuant 
to sections 302(c) or 1007(b)(1) of the Act (21 U.S.C. 822(c) or 
957(b)(1)) shall be exempt from maintaining the records required by this 
section.
    (b) Distributions referred to in paragraph (a) may be made through a 
freight forwarding facility operated by the person to whom the 
controlled substance is being returned provided that prior arrangement 
has been made for the return and the person making the distribution 
delivers the controlled substance directly to an agent or employee of 
the person to whom the controlled substance is being returned.

[65 FR 44679, July 19, 2000; 65 FR 45829, July 25, 2000, as amended at 
68 FR 41229, July 11, 2003]

[[Page 104]]



Sec. 1307.13  Incidental manufacture of controlled substances.

    Any registered manufacturer who, incidentally but necessarily, 
manufactures a controlled substance as a result of the manufacture of a 
controlled substance or basic class of controlled substance for which he 
is registered and has been issued an individual manufacturing quota 
pursuant to part 1303 of this chapter (if such substance or class is 
listed in Schedule I or II) shall be exempt from the requirement of 
registration pursuant to part 1301 of this chapter and, if such 
incidentally manufactured substance is listed in Schedule I or II, shall 
be exempt from the requirement of an individual manufacturing quota 
pursuant to part 1303 of this chapter, if such substances are disposed 
of in accordance with Sec. 1307.21.

[36 FR 7801, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973, 
and further redesignated at 62 FR 13967, Mar. 24, 1997]

                    Disposal of Controlled Substances



Sec. 1307.21  Procedure for disposing of controlled substances.

    (a) Any person in possession of any controlled substance and 
desiring or required to dispose of such substance may request assistance 
from the Special Agent in Charge of the Administration in the area in 
which the person is located for authority and instructions to dispose of 
such substance. The request should be made as follows:
    (1) If the person is a registrant, he/she shall list the controlled 
substance or substances which he/she desires to dispose of on DEA Form 
41, and submit three copies of that form to the Special Agent in Charge 
in his/her area; or
    (2) If the person is not a registrant, he/she shall submit to the 
Special Agent in Charge a letter stating:
    (i) The name and address of the person;
    (ii) The name and quantity of each controlled substance to be 
disposed of;
    (iii) How the applicant obtained the substance, if known; and
    (iv) The name, address, and registration number, if known, of the 
person who possessed the controlled substances prior to the applicant, 
if known.
    (b) The Special Agent in Charge shall authorize and instruct the 
applicant to dispose of the controlled substance in one of the following 
manners:
    (1) By transfer to person registered under the Act and authorized to 
possess the substance;
    (2) By delivery to an agent of the Administration or to the nearest 
office of the Administration;
    (3) By destruction in the presence of an agent of the Administration 
or other authorized person; or
    (4) By such other means as the Special Agent in Charge may determine 
to assure that the substance does not become available to unauthorized 
persons.
    (c) In the event that a registrant is required regularly to dispose 
of controlled substances, the Special Agent in Charge may authorize the 
registrant to dispose of such substances, in accordance with paragraph 
(b) of this section, without prior approval of the Administration in 
each instance, on the condition that the registrant keep records of such 
disposals and file periodic reports with the Special Agent in Charge 
summarizing the disposals made by the registrant. In granting such 
authority, the Special Agent in Charge may place such conditions as he 
deems proper on the disposal of controlled substances, including the 
method of disposal and the frequency and detail of reports.
    (d) This section shall not be construed as affecting or altering in 
any way the disposal of controlled substances through procedures 
provided in laws and regulations adopted by any State.

[36 FR 7801, Apr. 24, 1971, as amended at 37 FR 15922, Aug. 8, 1972. 
Redesignated at 38 FR 26609, Sept. 24, 1973, and amended at 47 FR 41735, 
Sept. 22, 1982; 62 FR 13967, Mar. 24, 1997]



Sec. 1307.22  Disposal of controlled substances by the Administration.

    Any controlled substance delivered to the Administration under Sec. 
1307.21 or forfeited pursuant to section 511 of the Act (21 U.S.C. 881) 
may be delivered to any department, bureau, or other agency of the 
United States or of any State upon proper application addressed to the 
Office of Diversion Control, Drug Enforcement Administration. See the

[[Page 105]]

Table of DEA Mailing Addresses in Sec. 1321.01 of this chapter for the 
current mailing address. The application shall show the name, address, 
and official title of the person or agency to whom the controlled drugs 
are to be delivered, including the name and quantity of the substances 
desired and the purpose for which intended. The delivery of such 
controlled drugs shall be ordered by the Administrator, if, in his 
opinion, there exists a medical or scientific need therefor.

[75 FR 10678, Mar. 9, 2010]

                         Special Exempt Persons



Sec. 1307.31  Native American Church.

    The listing of peyote as a controlled substance in Schedule I does 
not apply to the nondrug use of peyote in bona fide religious ceremonies 
of the Native American Church, and members of the Native American Church 
so using peyote are exempt from registration. Any person who 
manufactures peyote for or distributes peyote to the Native American 
Church, however, is required to obtain registration annually and to 
comply with all other requirements of law.



PART 1308_SCHEDULES OF CONTROLLED SUBSTANCES--Table of Contents



                           General Information

Sec.
1308.01 Scope of part 1308.
1308.02 Definitions.
1308.03 Administration Controlled Substances Code Number.

                                Schedules

1308.11 Schedule I.
1308.12 Schedule II.
1308.13 Schedule III.
1308.14 Schedule IV.
1308.15 Schedule V.

                     Excluded Nonnarcotic Substances

1308.21 Application for exclusion of a nonnarcotic substance.
1308.22 Excluded substances.

                      Exempt Chemical Preparations

1308.23 Exemption of certain chemical preparations; application.
1308.24 Exemption chemical preparations.

          Excluded Veterinary Anabolic Steroid Implant Products

1308.25 Exclusion of a veterinary anabolic steroid implant product; 
          application.
1308.26 Excluded veterinary anabolic steroid implant products.

                     Exempted Prescription Products

1308.31 Application for exemption of a nonnarcotic prescription product.
1308.32 Exempted prescription products.

                    Exempt Anabolic Steroid Products

1308.33 Exemption of certain anabolic steroid products; application.
1308.34 Exempt anabolic steroid products.

   Exempt cannabis plant material, and products made therefrom, that 
                      contain tetrahydrocannabinols

1308.35 Exemption of certain cannabis plant material, and products made 
          therefrom, that contain tetrahydrocannabinols.

                                Hearings

1308.41 Hearings generally.
1308.42 Purpose of hearing.
1308.43 Initiation of proceedings for rule-making.
1308.44 Request for hearing or appearance; waiver.
1308.45 Final order.
1308.46 Control required under international treaty.
1308.47 Control of immediate precursors.
1308.49 Emergency scheduling.

    Authority: 21 U.S.C. 811, 812, 871(b), unless otherwise noted.

    Source: 38 FR 8254, Mar. 30, 1973, unless otherwise noted. 
Redesignated at 38 FR 26609, Sept. 24, 1973.

                           General Information



Sec. 1308.01  Scope of part 1308.

    Schedules of controlled substances established by section 202 of the 
Act (21 U.S.C. 812), as they are changed, updated, and republished from 
time to time, are set forth in this part.



Sec. 1308.02  Definitions.

    Any term contained in this part shall have the definition set forth 
in section 102 of the Act (21 U.S.C. 802) or part 1300 of this chapter.

[62 FR 13967, Mar. 24, 1997]

[[Page 106]]



Sec. 1308.03  Administration Controlled Substances Code Number.

    (a) Each controlled substance, or basic class thereof, has been 
assigned an ``Administration Controlled Substances Code Number'' for 
purposes of identification of the substances or class on certain 
Certificates of Registration issued by the Administration pursuant to 
Sec. Sec. 1301.35 of this chapter and on certain order forms issued by 
the Administration pursuant to Sec. 1305.05(d) of this chapter. 
Applicants for procurement and/or individual manufacturing quotas must 
include the appropriate code number on the application as required in 
Sec. Sec. 1303.12(b) and 1303.22(a) of this chapter. Applicants for 
import and export permits must include the appropriate code number on 
the application as required in Sec. Sec. 1312.12(a) and 1312.22(a) of 
this chapter. Authorized registrants who desire to import or export a 
controlled substance for which an import or export permit is not 
required must include the appropriate Administration Controlled 
Substances Code Number beneath or beside the name of each controlled 
substance listed on the DEA Form 236 (Controlled Substance Import/Export 
Declaration) which is executed for such importation or exportation as 
required in Sec. Sec. 1312.18(c) and 1312.27(b) of this chapter.
    (b) Except as stated in paragraph (a) of this section, no applicant 
or registrant is required to use the Administration Controlled 
Substances Code Number for any purpose.

[38 FR 8254, Mar. 30, 1973. Redesignated at 38 FR 26609, Sept. 24, 1973 
and amended at 51 FR 15318, Apr. 23, 1986; 62 FR 13968, Mar. 24, 1997]

                                Schedules



Sec. 1308.11  Schedule I.

    (a) Schedule I shall consist of the drugs and other substances, by 
whatever official name, common or usual name, chemical name, or brand 
name designated, listed in this section. Each drug or substance has been 
assigned the DEA Controlled Substances Code Number set forth opposite 
it.
    (b) Opiates. Unless specifically excepted or unless listed in 
another schedule, any of the following opiates, including their isomers, 
esters, ethers, salts, and salts of isomers, esters and ethers, whenever 
the existence of such isomers, esters, ethers and salts is possible 
within the specific chemical designation (for purposes of paragraph 
(b)(34) only, the term isomer includes the optical and geometric 
isomers):

 
 
 
(1) Acetyl-alpha-methylfentanyl (N-[1-(1-methyl-2-phenethyl)-4-     9815
 piperidinyl]-N-phenylacetamide)................................
(2) Acetylmethadol..............................................    9601
(3) Allylprodine................................................    9602
(4) Alphacetylmethadol (except levo-alphacetylmethadol also         9603
 known as levo-alpha-acetylmethadol, levomethadyl acetate, or
 LAAM)..........................................................
(5) Alphameprodine..............................................    9604
(6) Alphamethadol...............................................    9605
(7) Alpha-methylfentanyl (N-[1-(alpha-methyl-beta-phenyl)ethyl-4-   9814
 piperidyl] propionanilide; 1-(1-methyl-2-phenylethyl)-4-(N-
 propanilido) piperidine).......................................
(8) Alpha-methylthiofentanyl (N-[1-methyl-2-(2-thienyl)ethyl-4-     9832
 piperidinyl]-N-phenylpropanamide)..............................
(9) Benzethidine................................................    9606
(10) Betacetylmethadol..........................................    9607
(11) Beta-hydroxyfentanyl (N-[1-(2-hydroxy-2-phenethyl)-4-          9830
 piperidinyl]-N-phenylpropanamide)..............................
(12) Beta-hydroxy-3-methylfentanyl (other name: N-[1-(2-hydroxy-    9831
 2-phenethyl)-3-methyl-4-piperidinyl]-N-phenylpropanamide.......
(13) Betameprodine..............................................    9608
(14) Betamethadol...............................................    9609
(15) Betaprodine................................................    9611
(16) Clonitazene................................................    9612
(17) Dextromoramide.............................................    9613
(18) Diampromide................................................    9615
(19) Diethylthiambutene.........................................    9616
(20) Difenoxin..................................................    9168
(21) Dimenoxadol................................................    9617
(22) Dimepheptanol..............................................    9618
(23) Dimethylthiambutene........................................    9619
(24) Dioxaphetyl butyrate.......................................    9621
(25) Dipipanone.................................................    9622
(26) Ethylmethylthiambutene.....................................    9623
(27) Etonitazene................................................    9624
(28) Etoxeridine................................................    9625
(29) Furethidine................................................    9626

[[Page 107]]

 
(30) Hydroxypethidine...........................................    9627
(31) Ketobemidone...............................................    9628
(32) Levomoramide...............................................    9629
(33) Levophenacylmorphan........................................    9631
(34) 3-Methylfentanyl (N-[3-methyl-1-(2-phenylethyl)-4-             9813
 piperidyl]-N-phenylpropanamide)................................
(35) 3-methylthiofentanyl (N-[(3-methyl-1-(2-thienyl)ethyl-4-       9833
 piperidinyl]-N-phenylpropanamide)..............................
(36) Morpheridine...............................................    9632
(37) MPPP (1-methyl-4-phenyl-4-propionoxypiperidine)............    9661
(38) Noracymethadol.............................................    9633
(39) Norlevorphanol.............................................    9634
(40) Normethadone...............................................    9635
(41) Norpipanone................................................    9636
(42) Para-fluorofentanyl (N-(4-fluorophenyl)-N-[1-(2-phenethyl)-    9812
 4-piperidinyl] propanamide.....................................
(43) PEPAP (1-(-2-phenethyl)-4-phenyl-4-acetoxypiperidine.......    9663
(44) Phenadoxone................................................    9637
(45) Phenampromide..............................................    9638
(46) Phenomorphan...............................................    9647
(47) Phenoperidine..............................................    9641
(48) Piritramide................................................    9642
(49) Proheptazine...............................................    9643
(50) Properidine................................................    9644
(51) Propiram...................................................    9649
(52) Racemoramide...............................................    9645
(53) Thiofentanyl (N-phenyl-N-[1-(2-thienyl)ethyl-4-piperidinyl]-   9835
 propanamide....................................................
(54) Tilidine...................................................    9750
(55) Trimeperidine..............................................    9646
 

    (c) Opium derivatives. Unless specifically excepted or unless listed 
in another schedule, any of the following opium derivatives, its salts, 
isomers, and salts of isomers whenever the existence of such salts, 
isomers, and salts of isomers is possible within the specific chemical 
designation:

 
 
 
(1) Acetorphine.................................................    9319
(2) Acetyldihydrocodeine........................................    9051
(3) Benzylmorphine..............................................    9052
(4) Codeine methylbromide.......................................    9070
(5) Codeine-N-Oxide.............................................    9053
(6) Cyprenorphine...............................................    9054
(7) Desomorphine................................................    9055
(8) Dihydromorphine.............................................    9145
(9) Drotebanol..................................................    9335
(10) Etorphine (except hydrochloride salt)......................    9056
(11) Heroin.....................................................    9200
(12) Hydromorphinol.............................................    9301
(13) Methyldesorphine...........................................    9302
(14) Methyldihydromorphine......................................    9304
(15) Morphine methylbromide.....................................    9305
(16) Morphine methylsulfonate...................................    9306
(17) Morphine-N-Oxide...........................................    9307
(18) Myrophine..................................................    9308
(19) Nicocodeine................................................    9309
(20) Nicomorphine...............................................    9312
(21) Normorphine................................................    9313
(22) Pholcodine.................................................    9314
(23) Thebacon...................................................    9315
 

    (d) Hallucinogenic substances. Unless specifically excepted or 
unless listed in another schedule, any material, compound, mixture, or 
preparation, which contains any quantity of the following hallucinogenic 
substances, or which contains any of its salts, isomers, and salts of 
isomers whenever the existence of such salts, isomers, and salts of 
isomers is possible within the specific chemical designation (for 
purposes of this paragraph only, the term ``isomer'' includes the 
optical, position and geometric isomers):

 
 
 
(1) Alpha-ethyltryptamine.......................................    7249
  Some trade or other names: etryptamine; Monase; [alpha]-ethyl-
   1H-indole-3-ethanamine; 3-(2-aminobutyl) indole; [alpha]-ET;
   and AET.
(2) 4-bromo-2,5-dimethoxy-amphetamine...........................    7391
  Some trade or other names: 4-bromo-2,5-dimethoxy-[alpha]-
   methylphenethylamine; 4-bromo-2,5-DMA
(3) 4-Bromo-2,5-dimethoxyphenethylamine.........................    7392
  Some trade or other names: 2-(4-bromo-2,5-dimethoxyphenyl)-1-
   aminoethane; alpha-desmethyl DOB; 2C-B, Nexus.
(4) 2,5-dimethoxyamphetamine....................................    7396
  Some trade or other names: 2,5-dimethoxy-[alpha]-
   methylphenethylamine; 2,5-DMA
(5) 2,5-dimethoxy-4-ethylamphet-amine...........................    7399

[[Page 108]]

 
  Some trade or other names: DOET
(6) 2,5-dimethoxy-4-(n)-propylthiophenethylamine (other name: 2C-   7348
 T-7)...........................................................
(7) 4-methoxyamphetamine........................................    7411
  Some trade or other names: 4-methoxy-[alpha]-
   methylphenethylamine; paramethoxyamphetamine, PMA
(8) 5-methoxy-3,4-methylenedioxy-amphetamine....................    7401
(9) 4-methyl-2,5-dimethoxy-amphetamine..........................    7395
  Some trade and other names: 4-methyl-2,5-dimethoxy-[alpha]-
   methylphenethylamine; ``DOM''; and ``STP''
(10) 3,4-methylenedioxy amphetamine.............................    7400
(11) 3,4-methylenedioxymethamphetamine (MDMA)...................    7405
(12) 3,4-methylenedioxy-N-ethylamphetamine (also known as N-        7404
 ethyl-alpha-methyl-3,4(methylenedioxy)-phenethylamine, N-ethyl
 MDA, MDE, MDEA.................................................
(13) N-hydroxy-3,4-methylenedioxyamphetamine (also known as N-      7402
 hydroxy-alpha-methyl-3,4(methylenedioxy)-phenethylamine, and N-
 hydroxy MDA....................................................
(14) 3,4,5-trimethoxy amphetamine...............................    7390
(15) 5-methoxy-N,N-dimethyltryptamine Some trade or other names:    7431
 5-methoxy-3-[2-(dimethylamino)ethyl]indole; 5-MeO-DMT..........
(16) Alpha-methyltryptamine (other name: AMT)...................    7432
(17) Bufotenine.................................................    7433
  Some trade and other names: 3-([beta]-Dimethylaminoethyl)-5-
   hydroxyindole; 3-(2-dimethylaminoethyl)-5-indolol; N, N-
   dimethylserotonin; 5-hydroxy-N,N-dimethyltryptamine; mappine
(18) Diethyltryptamine..........................................    7434
  Some trade and other names: N,N-Diethyltryptamine; DET
(19) Dimethyltryptamine.........................................    7435
  Some trade or other names: DMT
(20) 5-methoxy-N,N-diisopropyltryptamine (other name: 5-MeO-        7439
 DIPT)..........................................................
(21) Ibogaine...................................................    7260
  Some trade and other names: 7-Ethyl-6,6[beta],7,8,9,10,12,13-
   octahydro-2-methoxy-6,9-methano-5H-pyrido [1', 2':1,2]
   azepino [5,4-b] indole; Tabernanthe iboga
(22) Lysergic acid diethylamide.................................    7315
(23) Marihuana..................................................    7360
(24) Mescaline..................................................    7381
(25) Parahexyl--7374; some trade or other names: 3-Hexyl-1-
 hydroxy-7,8,9,10-tetrahydro-6,6,9-trimethyl-6H-
 dibenzo[b,d]pyran; Synhexyl.
(26) Peyote.....................................................    7415
  Meaning all parts of the plant presently classified
   botanically as Lophophora williamsii Lemaire, whether growing
   or not, the seeds thereof, any extract from any part of such
   plant, and every compound, manufacture, salts, derivative,
   mixture, or preparation of such plant, its seeds or extracts
  (Interprets 21 USC 812(c), Schedule I(c) (12))
(27) N-ethyl-3-piperidyl benzilate..............................    7482
(28) N-methyl-3-piperidyl benzilate.............................    7484
(29) Psilocybin.................................................    7437
(30) Psilocyn...................................................    7438
(31) Tetrahydrocannabinols......................................    7370

[[Page 109]]

 
  Meaning tetrahydrocannabinols naturally contained in a plant
   of the genus Cannabis (cannabis plant), as well as synthetic
   equivalents of the substances contained in the cannabis
   plant, or in the resinous extractives of such plant, and/or
   synthetic substances, derivatives, and their isomers with
   similar chemical structure and pharmacological activity to
   those substances contained in the plant, such as the
   following:
  1 cis or trans tetrahydrocannabinol, and their optical isomers
  6 cis or trans tetrahydrocannabinol, and their optical isomers
  3, 4 cis or trans tetrahydrocannabinol, and its optical
   isomers
  (Since nomenclature of these substances is not internationally
   standardized, compounds of these structures, regardless of
   numerical designation of atomic positions covered.)
(32) Ethylamine analog of phencyclidine.........................    7455
  Some trade or other names: N-ethyl-1-phenylcyclohexylamine, (1-
   phenylcyclohexyl)ethylamine, N-(1-
   phenylcyclohexyl)ethylamine, cyclohexamine, PCE
(33) Pyrrolidine analog of phencyclidine........................    7458
  Some trade or other names: 1-(1-phenylcyclohexyl)-pyrrolidine,
   PCPy, PHP
(34) Thiophene analog of phencyclidine..........................    7470
  Some trade or other names: 1-[1-(2-thienyl)-cyclohexyl]-
   piperidine, 2-thienylanalog of phencyclidine, TPCP, TCP
(35) 1-[1-(2-thienyl)cyclohexyl]pyrrolidine.....................    7473
  Some other names: TCPy
(36) 4-methylmethcathinone (Mephedrone).........................    1248
(37) 3,4-methylenedioxypyrovalerone (MDPV)......................    7535
(38) 2-(2,5-Dimethoxy-4-ethylphenyl)ethanamine (2C-E)...........    7509
(39) 2-(2,5-Dimethoxy-4-methylphenyl)ethanamine (2C-D)..........    7508
(40) 2-(4-Chloro-2,5-dimethoxyphenyl)ethanamine (2C-C)..........    7519
(41) 2-(4-Iodo-2,5-dimethoxyphenyl)ethanamine (2C-I)............    7518
(42) 2-[4-(Ethylthio)-2,5-dimethoxyphenyl]ethanamine (2C-T-2)...    7385
(43) 2-[4-(Isopropylthio)-2,5-dimethoxyphenyl]ethanamine (2C-T-     7532
 4).............................................................
(44) 2-(2,5-Dimethoxyphenyl)ethanamine (2C-H)...................    7517
(45) 2-(2,5-Dimethoxy-4-nitro-phenyl)ethanamine (2C-N)..........    7521
(46) 2-(2,5-Dimethoxy-4-(n)-propylphenyl)ethanamine (2C-P)......    7524
(47) 3,4-Methylenedioxy-N-methylcathinone (Methylone)...........    7540
 

    (e) Depressants. Unless specifically excepted or unless listed in 
another schedule, any material, compound, mixture, or preparation which 
contains any quantity of the following substances having a depressant 
effect on the central nervous system, including its salts, isomers, and 
salts of isomers whenever the existence of such salts, isomers, and 
salts of isomers is possible within the specific chemical designation:

 
 
 
(1) gamma-hydroxybutyric acid (some other names include GHB;        2010
 gamma-hydroxybutyrate; 4-hydroxybutyrate; 4-hydroxybutanoic
 acid; sodium oxybate; sodium oxybutyrate)......................
(2) Mecloqualone................................................    2572
(3) Methaqualone................................................    2565
 

    (f) Stimulants. Unless specifically excepted or unless listed in 
another

[[Page 110]]

schedule, any material, compound, mixture, or preparation which contains 
any quantity of the following substances having a stimulant effect on 
the central nervous system, including its salts, isomers, and salts of 
isomers:

 
 
 
(1) Aminorex (Some other names: aminoxaphen; 2-amino-5-phenyl-2-    1585
 oxazoline; or 4,5-dihydro-5-phenly-2-oxazolamine)..............
(2) N-Benzylpiperazine (some other names: BZP, 1-                   7493
 benzylpiperazine)..............................................
(3) Cathinone...................................................    1235
  Some trade or other names: 2-amino-1-phenyl-1-propanone, alpha-
   aminopropiophenone, 2-aminopropiophenone, and norephedrone
(4) Fenethylline................................................    1503
(5) Methcathinone (Some other names: 2-(methylamino)-               1237
 propiophenone; alpha-(methylamino)propiophenone; 2-
 (methylamino)-1-phenylpropan-1-one; alpha-N-
 methylaminopropiophenone; monomethylpropion; ephedrone; N-
 methylcathinone; methylcathinone; AL-464; AL-422; AL-463 and
 UR1432), its salts, optical isomers and salts of optical
 isomers........................................................
(6) ()cis-4-methylaminorex (()cis-4,5-dihydro-4-methyl-5-phenyl-2-
 oxazolamine)...................................................
(7) N-ethylamphetamine..........................................    1475
(8) N,N-dimethylamphetamine (also known as N,N-alpha-trimethyl-     1480
 benzeneethanamine; N,N-alpha-trimethylphenethylamine)..........
 

    (g) Cannabimimetic agents. Unless specifically exempted or unless 
listed in another schedule, any material, compound, mixture, or 
preparation which contains any quantity of the following substances, or 
which contains their salts, isomers, and salts of isomers whenever the 
existence of such salts, isomers, and salts of isomers is possible 
within the specific chemical designation:

 
 
 
(1) 5-(1,1-dimethylheptyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-         7297
 phenol (CP-47,497).............................................
(2) 5-(1,1-dimethyloctyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-phenol    7298
 (cannabicyclohexanol or CP-47,497 C8-homolog)..................
(3) 1-pentyl-3-(1-naphthoyl)indole (JWH-018 and AM678)..........    7118
(4) 1-butyl-3-(1-naphthoyl)indole (JWH-073).....................    7173
(5) 1-hexyl-3-(1-naphthoyl)indole (JWH-019).....................    7019
(6) 1-[2-(4-morpholinyl)ethyl]-3-(1-naphthoyl)indole (JWH-200)..    7200
(7) 1-pentyl-3-(2-methoxyphenylacetyl)indole (JWH-250)..........    6250
(8) 1-pentyl-3-[1-(4-methoxynaphthoyl)]indole (JWH-081).........    7081
(9) 1-pentyl-3-(4-methyl-1-naphthoyl)indole (JWH-122)...........    7122
(10) 1-pentyl-3-(4-chloro-1-naphthoyl)indole (JWH-398)..........    7398
(11) 1-(5-fluoropentyl)-3-(1-naphthoyl)indole (AM2201)..........    7201
(12) 1-(5-fluoropentyl)-3-(2-iodobenzoyl)indole (AM694).........    7694
(13) 1-pentyl-3-[(4-methoxy)-benzoyl]indole (SR-19 and RCS-4)...    7104
(14) 1-cyclohexylethyl-3-(2-methoxyphenylacetyl)indole 7008 (SR-    7008
 18 and RCS-8)..................................................
(15) 1-pentyl-3-(2-chlorophenylacetyl)indole (JWH-203)..........    7203
 

    (h) Temporary listing of substances subject to emergency scheduling. 
Any material, compound, mixture or preparation which contains any 
quantity of the following substances:
    (1) 3,4-methylenedioxy-N-methylcathinone (Other names: methylone)--
7540
    (2) 5-(1,1-Dimethyloctyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-phenol, 
its optical, positional, and geometric isomers, salts and salts of 
isomers--7298 (Other names: cannabicyclohexanol and CP-47,497 C8 
homologue)
    (3) 1-Butyl-3-(1-naphthoyl)indole, its optical, positional, and 
geometric isomers, salts and salts of isomers--7173 (Other names: JWH-
073)
    (4) 1-[2-(4-Morpholinyl)ethyl]-3-(1-naphthoyl)indole, its optical, 
positional, and geometric isomers, salts

[[Page 111]]

and salts of isomers--7200 (Other names: JWH-200)
    (5) 1-Pentyl-3-(1-naphthoyl)indole, its optical, positional, and 
geometric isomers, salts and salts of isomers--7118 (Other names: JWH-
018 and AM678)
    (6) 4-methyl-N-methylcathinone--1248 (Other names: mephedrone)
    (7) 3,4-methylenedioxy-N-methylcathinone--7540 (Other names: 
methylone)
    (8) 3,4-methylenedioxypyrovalerone--7535 (Other names: MDPV)
    (9) (1-pentyl-1H-indol-3-yl)(2,2,3,3-
tetramethylcyclopropyl)methanone, its optical, positional, and geometric 
isomers, salts and salts of isomers--7144 (Other names: UR-144, 1-
pentyl-3-(2,2,3,3-tetramethylcyclopropoyl)indole)
    (10) [1-(5-fluoro-pentyl)-1H-indol-3-yl](2,2,3,3-
tetramethylcyclopropyl)methanone, its optical, positional, and geometric 
isomers, salts and salts of isomers--7011 (Other names: 5-fluoro-UR-144, 
5-F-UR-144, XLR11, 1-(5-fluoro-pentyl)-3-(2,2,3,3-
tetramethylcyclopropoyl)indole)
    (11) N-(1-adamantyl)-1-pentyl-1H-indazole-3-carboxamide, its 
optical, positional, and geometric isomers, salts and salts of isomers--
7048 (Other names: APINACA, AKB48)
    (12) 2-(4-iodo-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl)ethanamine, 
its optical, positional, and geometric isomers, salts and salts of 
isomers--7538 (Other names: 25I-NBOMe; 2C-I-NBOMe; 25I; Cimbi-5)
    (13) 2-(4-chloro-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl)ethanamine, 
its optical, positional, and geometric isomers, salts and salts of 
isomers--7537 (Other names: 25C-NBOMe; 2C-C-NBOMe; 25C; Cimbi-82)
    (14) 2-(4-bromo-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl)ethanamine, 
its optical, positional, and geometric isomers, salts and salts of 
isomers--7536
    (Other names: 25B-NBOMe; 2C-B-NBOMe; 25B; Cimbi-36)
    (15) Quinolin-8-yl 1-pentyl-1H-indole-3-carboxylate, its optical, 
positional, and geometric isomers, salts and salts of isomers--7222 
(Other names: PB-22; QUPIC)
    (16) Quinolin-8-yl 1-(5-fluoropentyl)-1H-indole-3-carboxylate, its 
optical, positional, and geometric isomers, salts and salts of isomers--
7225 (Other names: 5-fluoro-PB-22; 5F-PB-22)
    (17) N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-(4-fluorobenzyl)-1H-
indazole-3-carboxamide, its optical, positional, and geometric isomers, 
salts and salts of isomers--7012 (Other names: AB-FUBINACA)
    (18) N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-pentyl-1H-indazole-
3-carboxamide, its optical, positional, and geometric isomers, salts and 
salts of isomers--7035 (Other names: ADB-PINACA)
    (19) 4-methyl-N-ethylcathinone, its optical, positional, and 
geometric isomers, salts and salts of isomers--1249 (Other names: 4-MEC; 
2-(ethylamino)-1-(4-methylphenyl)propan-1-one)
    (20) 4-methyl-alpha-pyrrolidinopropiophenone, its optical, 
positional, and geometric isomers, salts and salts of isomers--7498 
(Other names: 4-MePPP; MePPP; 4-methyl-[alpha]-pyrrolidinopropiophenone; 
1-(4-methylphenyl)-2-(pyrrolidin-1-yl)-propan-1-one)
    (21) alpha-pyrrolidinopentiophenone, its optical, positional, and 
geometric isomers, salts and salts of isomers--7545 (Other names: 
[alpha]-PVP; [alpha]-pyrrolidinovalerophenone; 1-phenyl-2-(pyrrolidin-1-
yl)pentan-1-one)
    (22) Butylone, its optical, positional, and geometric isomers, salts 
and salts of isomers--7541 (Other names: bk-MBDB; 1-(1,3-benzodioxol-5-
yl)-2-(methylamino)butan-1-one)
    (23) Pentedrone, its optical, positional, and geometric isomers, 
salts and salts of isomers--1246 (Other names: [alpha]-
methylaminovalerophenone; 2-(methylamino)-1-phenylpentan-1-one)
    (24) Pentylone, its optical, positional, and geometric isomers, 
salts and salts of isomers--7542 (Other names: bk-MBDP; 1-(1,3-
benzodioxol-5-yl)-2-(methylamino)pentan-1-one)
    (25) 4-fluoro-N-methylcathinone, its optical, positional, and 
geometric isomers, salts and salts of isomers--1238 (Other names: 4-FMC; 
flephedrone; 1-(4-fluorophenyl)-2-(methylamino)propan-1-one)
    (26) 3-fluoro-N-methylcathinone, its optical, positional, and 
geometric isomers, salts and salts of isomers--1233 (Other names: 3-FMC; 
1-(3-

[[Page 112]]

fluorophenyl)-2-(methylamino)propan-1-one)
    (27) Naphyrone, its optical, positional, and geometric isomers, 
salts and salts of isomers--1258 (Other names: naphthylpyrovalerone; 1-
(naphthalen-2-yl)-2-(pyrrolidin-1-yl)pentan-1-one)
    (28) alpha-pyrrolidinobutiophenone, its optical, positional, and 
geometric isomers, salts and salts of isomers--7546 (Other names: 
[alpha]-PBP; 1-phenyl-2-(pyrrolidin-1-yl)butan-1-one)

[39 FR 22141, June 20, 1974]

    Editorial Note: For Federal Register citations affecting Sec. 
1308.11, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and at www.fdsys.gov.



Sec. 1308.12  Schedule II.

    (a) Schedule II shall consist of the drugs and other substances, by 
whatever official name, common or usual name, chemical name, or brand 
name designated, listed in this section. Each drug or substance has been 
assigned the Controlled Substances Code Number set forth opposite it.
    (b) Substances, vegetable origin or chemical synthesis. Unless 
specifically excepted or unless listed in another schedule, any of the 
following substances whether produced directly or indirectly by 
extraction from substances of vegetable origin, or independently by 
means of chemical synthesis, or by a combination of extraction and 
chemical synthesis:
    (1) Opium and opiate, and any salt, compound, derivative, or 
preparation of opium or opiate excluding apomorphine, thebaine-derived 
butorphanol, dextrorphan, nalbuphine, nalmefene, naloxone, and 
naltrexone, and their respective salts, but including the following:

 
 
 
(i) Codeine.....................................................    9050
(ii) Dihydroetorphine...........................................    9334
(iii) Ethylmorphine.............................................    9190
(iv) Etorphine hydrochloride....................................    9059
(v) Granulated opium............................................    9640
(vi) Hydrocodone................................................    9193
(vii) Hydromorphone.............................................    9150
(viii) Metopon..................................................    9260
(ix) Morphine...................................................    9300
(x) Opium extracts..............................................    9610
(xi) Opium fluid................................................    9620
(xii) Oripavine.................................................    9330
(xiii) Oxycodone................................................    9143
(xiv) Oxymorphone...............................................    9652
(xv) Powdered opium.............................................    9639
(xvi) Raw opium.................................................    9600
(xvii) Thebaine.................................................    9333
(xviii) Tincture of opium.......................................    9630
 

    (2) Any salt, compound, derivative, or preparation thereof which is 
chemically equivalent or identical with any of the substances referred 
to in paragraph (b) (1) of this section, except that these substances 
shall not include the isoquinoline alkaloids of opium.
    (3) Opium poppy and poppy straw.
    (4) Coca leaves (9040) and any salt, compound, derivative or 
preparation of coca leaves (including cocaine (9041) and ecgonine (9180) 
and their salts, isomers, derivatives and salts of isomers and 
derivatives), and any salt, compound, derivative, or preparation thereof 
which is chemically equivalent or identical with any of these 
substances, except that the substances shall not include decocainized 
coca leaves or extraction of coca leaves, which extractions do not 
contain cocaine or ecgonine.
    (5) Concentrate of poppy straw (the crude extract of poppy straw in 
either liquid, solid or powder form which contains the phenanthrene 
alkaloids of the opium poppy), 9670.
    (c) Opiates. Unless specifically excepted or unless in another 
schedule any of the following opiates, including its isomers, esters, 
ethers, salts and salts of isomers, esters and ethers whenever the 
existence of such isomers, esters, ethers, and salts is possible within 
the specific chemical designation, dextrorphan and levopropoxyphene 
excepted:

 
 
 
(1) Alfentanil..................................................    9737
(2) Alphaprodine................................................    9010
(3) Anileridine.................................................    9020
(4) Bezitramide.................................................    9800
(5) Bulk dextropropoxyphene (non-dosage forms)..................    9273
(6) Carfentanil.................................................    9743
(7) Dihydrocodeine..............................................    9120
(8) Diphenoxylate...............................................    9170
(9) Fentanyl....................................................    9801
(10) Isomethadone...............................................    9226
(11) Levo-alphacetylmethadol....................................    9648

[[Page 113]]

 
  [Some other names: levo-alpha-acetylmethadol, levomethadyl
   acetate, LAAM]
(12) Levomethorphan.............................................    9210
(13) Levorphanol................................................    9220
(14) Metazocine.................................................    9240
(15) Methadone..................................................    9250
(16) Methadone-Intermediate, 4-cyano-2-dimethylamino-4,4-           9254
 diphenyl butane................................................
(17) Moramide-Intermediate, 2-methyl-3-morpholino-1, 1-             9802
 diphenylpropane-carboxylic acid................................
(18) Pethidine (meperidine).....................................    9230
(19) Pethidine-Intermediate-A, 4-cyano-1-methyl-4-                  9232
 phenylpiperidine...............................................
(20) Pethidine-Intermediate-B, ethyl-4-phenylpiperidine-4-          9233
 carboxylate....................................................
(21) Pethidine-Intermediate-C, 1-methyl-4-phenylpiperidine-4-       9234
 carboxylic acid................................................
(22) Phenazocine................................................    9715
(23) Piminodine.................................................    9730
(24) Racemethorphan.............................................    9732
(25) Racemorphan................................................    9733
(26) Remifentanil...............................................    9739
(27) Sufentanil.................................................    9740
(28) Tapentadol.................................................    9780
 

    (d) Stimulants. Unless specifically excepted or unless listed in 
another schedule, any material, compound, mixture, or preparation which 
contains any quantity of the following substances having a stimulant 
effect on the central nervous system:

 
 
 
(1) Amphetamine, its salts, optical isomers, and salts of its       1100
 optical isomers................................................
(2) Methamphetamine, its salts, isomers, and salts of its           1105
 isomers........................................................
(3) Phenmetrazine and its salts.................................    1631
(4) Methylphenidate.............................................    1724
(5) Lisdexamfetamine, its salts, isomers, and salts of its         1205.
 isomers........................................................
 

    (e) Depressants. Unless specifically excepted or unless listed in 
another schedule, any material, compound, mixture, or preparation which 
contains any quantity of the following substances having a depressant 
effect on the central nervous system, including its salts, isomers, and 
salts of isomers whenever the existence of such salts, isomers, and 
salts of isomers is possible within the specific chemical designation:

 
 
 
(1) Amobarbital.................................................    2125
(2) Glutethimide................................................    2550
(3) Pentobarbital...............................................    2270
(4) Phencyclidine...............................................    7471
(5) Secobarbital................................................    2315
 

    (f) Hallucinogenic substances.

 
 
 
(1) Nabilone....................................................    7379
  [Another name for nabilone: ()-trans-3-
   (1,1-dimethylheptyl)-6,6a,7,8,10,10a-hexahydro-1-hydroxy-6,6-
   dimethyl-9H-dibenzo[b,d]pyran-9-one]
 

    (g) Immediate precursors. Unless specifically excepted or unless 
listed in another schedule, any material, compound, mixture, or 
preparation which contains any quantity of the following substances:
    (1) Immediate precursor to amphetamine and methamphetamine:

 
 
 
(i) Phenylacetone...............................................    8501
  Some trade or other names: phenyl-2-propanone; P2P; benzyl
   methyl ketone; methyl benzyl ketone;
 

    (2) Immediate precursors to phencyclidine (PCP):

 
 
 
(i) 1-phenylcyclohexylamine.....................................    7460
(ii) 1-piperidinocyclohexanecarbonitrile (PCC)..................    8603
 

    (3) Immediate precursor to fentanyl:

 
 
 
(i) 4-anilino-N-phenethyl-4-piperidine (ANPP)...................    8333
 

    (ii) [Reserved]

[39 FR 22142, June 20, 1974]

    Editorial Note: For Federal Register citations affecting Sec. 
1308.12, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and at www.fdsys.gov.

[[Page 114]]



Sec. 1308.13  Schedule III.

    (a) Schedule III shall consist of the drugs and other substances, by 
whatever official name, common or usual name, chemical name, or brand 
name designated, listed in this section. Each drug or substance has been 
assigned the DEA Controlled Substances Code Number set forth opposite 
it.
    (b) Stimulants. Unless specifically excepted or unless listed in 
another schedule, any material, compound, mixture, or preparation which 
contains any quantity of the following substances having a stimulant 
effect on the central nervous system, including its salts, isomers 
(whether optical, positional, or geometric), and salts of such isomers 
whenever the existence of such salts, isomers, and salts of isomers is 
possible within the specific chemical designation:

 
 
 
(1) Those compounds, mixtures, or preparations in dosage unit       1405
 form containing any stimulant substances listed in schedule II
 which compounds, mixtures, or preparations were listed on
 August 25, 1971, as excepted compounds under Sec. 1308.32,
 and any other drug of the quantitative composition shown in
 that list for those drugs or which is the same except that it
 contains a lesser quantity of controlled substances............
(2) Benzphetamine...............................................    1228
(3) Chlorphentermine............................................    1645
(4) Clortermine.................................................    1647
(5) Phendimetrazine.............................................    1615
 

    (c) Depressants. Unless specifically excepted or unless listed in 
another schedule, any material, compound, mixture, or preparation which 
contains any quantity of the following substances having a depressant 
effect on the central nervous system:

 
 
 
(1) Any compound, mixture or preparation containing:
    (i) Amobarbital.............................................    2126
    (ii) Secobarbital...........................................    2316
    (iii) Pentobarbital.........................................    2271
  or any salt thereof and one or more other active medicinal
   ingredients which are not listed in any schedule.
(2) Any suppository dosage form containing:
    (i) Amobarbital.............................................    2126
    (ii) Secobarbital...........................................    2316
    (iii) Pentobarbital.........................................    2271
  or any salt of any of these drugs and approved by the Food and
   Drug Administration for marketing only as a suppository.
(3) Any substance which contains any quantity of a derivative of    2100
 barbituric acid or any salt thereof............................
(4) Chlorhexadol................................................    2510
(5) Embutramide.................................................    2020
(6) Any drug product containing gamma hydroxybutyric acid,          2012
 including its salts, isomers, and salts of isomers, for which
 an application is approved under section 505 of the Federal
 Food, Drug, and Cosmetic Act...................................
(7) Ketamine, its salts, isomers, and salts of isomers..........    7285
  [Some other names for ketamine: ()-2-(2-
   chlorophenyl)-2-(methylamino)-cyclohexanone]
(8) Lysergic acid...............................................    7300
(9) Lysergic acid amide.........................................    7310
(10) Methyprylon................................................    2575
(11) Perampanel, and its salts, isomers, and salts of isomers...    2261
(12) Sulfondiethylmethane.......................................    2600
(13) Sulfonethylmethane.........................................    2605
(14) Sulfonmethane..............................................    2610
(15) Tiletamine and zolazepam or any salt thereof...............    7295
  Some trade or other names for a tiletamine-zolazepam
   combination product:
    Telazol.....................................................
  Some trade or other names for tiletamine:
    2-(ethylamino)-2-(2-thienyl)-cyclohexanone..................

[[Page 115]]

 
  Some trade or other names for zolazepam:
    4-(2-fluorophenyl)-6,8-dihydro-1,3,8-trimethylpyrazolo-[3,4-
     e] [1,4]-diazepin-7(1H)-one, flupyrazapon..................
 

    (d) Nalorphine 9400.
    (e) Narcotic drugs. Unless specifically excepted or unless listed in 
another schedule:

 
 
 
(1) Any material, compound, mixture, or preparation containing
 any of the following narcotic drugs, or their salts calculated
 as the free anhydrous base or alkaloid, in limited quantities
 as set forth below:
    (i) Not more than 1.8 grams of codeine per 100 milliliters      9803
     or not more than 90 milligrams per dosage unit, with an
     equal or greater quantity of an isoquinoline alkaloid of
     opium......................................................
    (ii) Not more than 1.8 grams of codeine per 100 milliliters     9804
     or not more than 90 milligrams per dosage unit, with one or
     more active, nonnarcotic ingredients in recognized
     therapeutic amounts........................................
    (iii) Not more than 300 milligrams of dihydrocodeinone          9805
     (hydrocodone) per 100 milliliters or not more than 15
     milligrams per dosage unit, with a fourfold or greater
     quantity of an isoquinoline alkaloid of opium..............
    (iv) Not more than 300 milligrams of dihydrocodeinone           9806
     (hydrocodone) per 100 milliliters or not more than 15
     milligrams per dosage unit, with one or more active
     nonnarcotic ingredients in recognized therapeutic amounts..
    (v) Not more than 1.8 grams of dihydrocodeine per 100           9807
     milliliters or not more than 90 milligrams per dosage unit,
     with one or more active nonnarcotic ingredients in
     recognized therapeutic amounts.............................
    (vi) Not more than 300 milligrams of ethylmorphine per 100      9808
     milliliters or not more than 15 milligrams per dosage unit,
     with one or more active, nonnarcotic ingredients in
     recognized therapeutic amounts.............................
    (vii) Not more than 500 milligrams of opium per 100             9809
     milliliters or per 100 grams or not more than 25 milligrams
     per dosage unit, with one or more active, nonnarcotic
     ingredients in recognized therapeutic amounts..............
    (viii) Not more than 50 milligrams of morphine per 100          9810
     milliliters or per 100 grams, with one or more active,
     nonnarcotic ingredients in recognized therapeutic amounts..
 (2) Any material, compound, mixture, or preparation containing
 any of the following narcotic drugs or their salts, as set
 forth below:
    (i) Buprenorphine...........................................    9064
    (ii) [Reserved].............................................
 


[[Page 116]]

    (f) Anabolic Steroids. Unless specifically excepted or unless listed 
in another schedule, any material, compound, mixture or preparation 
containing any quantity of the following substances, including its 
salts, esters and ethers:
    (1) Anabolic steroids (see Sec. 1300.01 of this chapter)--4000
    (2) [Reserved]

    (g) Hallucinogenic substances. (1) Dronabinol (synthetic) in sesame 
oil and encapsulated in a soft gelatin capsule in a U.S. Food and Drug 
Administration approved product--7369.

[Some other names for dronabinol: (6aR-trans)-6a,7,8,10a-tetrahydro-
6,6,9-trimethyl-3-pentyl-6H-dibenzo [b,d]pyran-1-ol] or (-)-delta-9-
(trans)-tetrahydrocannabinol]

    (2) [Reserved]

[39 FR 22142, June 20, 1974]

    Editorial Note: For Federal Register citations affecting Sec. 
1308.13, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and at www.fdsys.gov.



Sec. 1308.14  Schedule IV.

    (a) Schedule IV shall consist of the drugs and other substances, by 
whatever official name, common or usual name, chemical name, or brand 
name designated, listed in this section. Each drug or substance has been 
assigned the DEA Controlled Substances Code Number set forth opposite 
it.
    (b) Narcotic drugs. Unless specifically excepted or unless listed in 
another schedule, any material, compound, mixture, or preparation 
containing any of the following narcotic drugs, or their salts 
calculated as the free anhydrous base or alkaloid, in limited quantities 
as set forth below:

 
 
 
(1) Not more than 1 milligram of difenoxin and not less than 25     9167
 micrograms of atropine sulfate per dosage unit.................
(2) Dextropropoxyphene (alpha-(+)-4-dimethylamino-1,2-diphenyl-3-   9278
 methyl-2-propionoxybutane).....................................
 

    (c) Depressants. Unless specifically excepted or unless listed in 
another schedule, any material, compound, mixture, or preparation which 
contains any quantity of the following substances, including its salts, 
isomers, and salts of isomers whenever the existence of such salts, 
isomers, and salts of isomers is possible within the specific chemical 
designation:

 
 
 
(1) Alfaxalone..................................................    2731
(2) Alprazolam..................................................    2882
(3) Barbital....................................................    2145
(4) Bromazepam..................................................    2748
(5) Camazepam...................................................    2749
(6) Carisoprodol................................................    8192
(7) Chloral betaine.............................................    2460
(8) Chloral hydrate.............................................    2465
(9) Chlordiazepoxide............................................    2744
(10) Clobazam...................................................    2751
(11) Clonazepam.................................................    2737
(12) Clorazepate................................................    2768
(13) Clotiazepam................................................    2752
(14) Cloxazolam.................................................    2753
(15) Delorazepam................................................    2754
(16) Diazepam...................................................    2765
(17) Dichloralphenazone.........................................    2467
(18) Estazolam..................................................    2756
(19) Ethchlorvynol..............................................    2540
(20) Ethinamate.................................................    2545
(21) Ethyl loflazepate..........................................    2758
(22) Fludiazepam................................................    2759
(23) Flunitrazepam..............................................    2763
(24) Flurazepam.................................................    2767
(25) Fospropofol................................................    2138
(26) Halazepam..................................................    2762
(27) Haloxazolam................................................    2771
(28) Ketazolam..................................................    2772
(29) Loprazolam.................................................    2773
(30) Lorazepam..................................................    2885
(31) Lormetazepam...............................................    2774
(32) Mebutamate.................................................    2800
(33) Medazepam..................................................    2836
(34) Meprobamate................................................    2820
(35) Methohexital...............................................    2264
(36) Methylphenobarbital (mephobarbital)........................    2250
(37) Midazolam..................................................    2884
(38) Nimetazepam................................................    2837
(39) Nitrazepam.................................................    2834
(40) Nordiazepam................................................    2838
(41) Oxazepam...................................................    2835
(42) Oxazolam...................................................    2839
(43) Paraldehyde................................................    2585
(44) Petrichloral...............................................    2591
(45) Phenobarbital..............................................    2285
(46) Pinazepam..................................................    2883
(47) Prazepam...................................................    2764
(48) Quazepam...................................................    2881
(49) Temazepam..................................................    2925
(50) Tetrazepam.................................................    2886
(51) Triazolam..................................................    2887

[[Page 117]]

 
(52) Zaleplon...................................................    2781
(53) Zolpidem...................................................    2783
(54) Zopiclone..................................................    2784
 

    (d) Fenfluramine. Any material, compound, mixture, or preparation 
which contains any quantity of the following substances, including its 
salts, isomers (whether optical, position, or geometric), and salts of 
such isomers, whenever the existence of such salts, isomers, and salts 
of isomers is possible:

 
 
 
(1) Fenfluramine................................................    1670
 

    (e) Lorcaserin. Any material, compound, mixture, or preparation 
which contains any quantity of the following substances, including its 
salts, isomers, and salts of such isomers, whenever the existence of 
such salts, isomers, and salts of isomers is possible:

 
 
 
(1) Lorcaserin..................................................    1625
 

    (f) Stimulants. Unless specifically excepted or unless listed in 
another schedule, any material, compound, mixture, or preparation which 
contains any quantity of the following substances having a stimulant 
effect on the central nervous system, including its salts, isomers and 
salts of isomers:

 
 
 
(1) Cathine ((+)-norpseudoephedrine)............................    1230
(2) Diethylpropion..............................................    1610
(3) Fencamfamin.................................................    1760
(4) Fenproporex.................................................    1575
(5) Mazindol....................................................    1605
(6) Mefenorex...................................................    1580
(7)Modafinil....................................................    1680
(8) Pemoline (including organometallic complexes and chelates       1530
 thereof).......................................................
(9) Phentermine.................................................    1640
(10) Pipradrol..................................................    1750
(11) Sibutramine................................................    1675
(12) SPA ((-)-1-dimethylamino- 1,2-diphenylethane)..............    1635
 

    (g) Other substances. Unless specifically excepted or unless listed 
in another schedule, any material, compound, mixture or preparation 
which contains any quantity of the following substances, including its 
salts:

 
 
 
(1) Pentazocine.................................................    9709
(2) Butorphanol (including its optical isomers).................    9720
 


[39 FR 22143, June 20, 1974]

    Editorial Note: For Federal Register citations affecting Sec. 
1308.14, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and at www.fdsys.gov.



Sec. 1308.15  Schedule V.

    (a) Schedule V shall consist of the drugs and other substances, by 
whatever official name, common or usual name, chemical name, or brand 
name designated, listed in this section.
    (b) Narcotic drugs. Unless specifically excepted or unless listed in 
another schedule, any material, compound, mixture, or preparation 
containing any of the following narcotic drugs and their salts, as set 
forth below:
    (1) [Reserved]
    (c) Narcotic drugs containing non-narcotic active medicinal 
ingredients. Any compound, mixture, or preparation containing any of the 
following narcotic drugs, or their salts calculated as the free 
anhydrous base or alkaloid, in limited quantities as set forth below, 
which shall include one or more non-narcotic active medicinal 
ingredients in sufficient proportion to confer upon the compound, 
mixture, or preparation valuable medicinal qualities other than those 
possessed by narcotic drugs alone:
    (1) Not more than 200 milligrams of codeine per 100 milliliters or 
per 100 grams.
    (2) Not more than 100 milligrams of dihydrocodeine per 100 
milliliters or per 100 grams.
    (3) Not more than 100 milligrams of ethylmorphine per 100 
milliliters or per 100 grams.
    (4) Not more than 2.5 milligrams of diphenoxylate and not less than 
25 micrograms of atropine sulfate per dosage unit.
    (5) Not more than 100 milligrams of opium per 100 milliliters or per 
100 grams.
    (6) Not more than 0.5 milligram of difenoxin and not less than 25 
micrograms of atropine sulfate per dosage unit.
    (d) Stimulants. Unless specifically exempted or excluded or unless 
listed in

[[Page 118]]

another schedule, any material, compound, mixture, or preparation which 
contains any quantity of the following substances having a stimulant 
effect on the central nervous system, including its salts, isomers and 
salts of isomers:

 
 
 
(1) Pyrovalerone................................................   1485.
(2) [Reserved]..................................................
 

    (e) Depressants. Unless specifically exempted or excluded or unless 
listed in another schedule, any material, compound, mixture, or 
preparation which contains any quantity of the following substances 
having a depressant effect on the central nervous system, including its 
salts:

 
 
 
(1) Ezogabine [N-[2-amino-4-(4-fluorobenzylamino)-phenyl]-          2779
 carbamic acid ethyl ester].....................................
(2) Lacosamide [(R)-2-acetoamido-N-benzyl-3-methoxy-                2746
 propionamide]..................................................
(3) Pregabalin [(S)-3-(aminomethyl)-5-methylhexanoic acid]......    2782
 


[39 FR 22143, June 20, 1974, as amended at 43 FR 38383, Aug. 28, 1978; 
44 FR 40888, July 13, 1979; 47 FR 49841, Nov. 3, 1982; 50 FR 8108, Feb. 
28, 1985; 52 FR 5952, Feb. 27, 1987; 53 FR 10870, Apr. 4, 1988; 56 FR 
61372, Dec. 3, 1991; 67 FR 62370, Oct. 7, 2002; 70 FR 43635, July 28, 
2005; 74 FR 23790, May 21, 2009; 76 FR 77899, Dec. 15, 2011]

                     Excluded Nonnarcotic Substances



Sec. 1308.21  Application for exclusion of a nonnarcotic substance.

    (a) Any person seeking to have any nonnarcotic drug that may, under 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301), be lawfully 
sold over the counter without a prescription, excluded from any 
schedule, pursuant to section 201(g)(1) of the Act (21 U.S.C. 
811(g)(1)), may apply to the Office of Diversion Control, Drug 
Enforcement Administration. See the Table of DEA Mailing Addresses in 
Sec. 1321.01 of this chapter for the current mailing address.
    (b) An application for an exclusion under this section shall contain 
the following information:
    (1) The name and address of the applicant;
    (2) The name of the substance for which exclusion is sought; and
    (3) The complete quantitative composition of the substance.
    (c) Within a reasonable period of time after the receipt of an 
application for an exclusion under this section, the Administrator shall 
notify the applicant of his acceptance or nonacceptance of his 
application, and if not accepted, the reason therefore. The 
Administrator need not accept an application for filing if any of the 
requirements prescribed in paragraph (b) of this section is lacking or 
is not set forth as to be readily understood. If the applicant desires, 
he may amend the application to meet the requirements of paragraph (b) 
of this section. If the application is accepted for filing, the 
Administrator shall issue and publish in the Federal Register his order 
on the application, which shall include a reference to the legal 
authority under which the order is issued and the findings of fact and 
conclusions of law upon which the order is based. This order shall 
specify the date on which it shall take effect. The Administrator shall 
permit any interested person to file written comments on or objections 
to the order within 60 days of the date of publication of his order in 
the Federal Register. If any such comments or objections raise 
significant issues regarding any finding of fact or conclusion of law 
upon which the order is based, the Administrator shall immediately 
suspend the effectiveness of the order until he may reconsider the 
application in light of the comments and objections filed. Thereafter, 
the Administrator shall reinstate, revoke, or amend his original order 
as he determines appropriate.
    (d) The Administrator may at any time revoke any exclusion granted 
pursuant to section 201(g) of the Act (21 U.S.C. 811(g)) by following 
the procedures set forth in paragraph (c) of this section for handling 
an application for an exclusion which has been accepted for filing.

[38 FR 8254, Mar. 30, 1973, as amended at 70 FR 74657, Dec. 16, 2005; 75 
FR 10678, Mar. 9, 2010]

[[Page 119]]



Sec. 1308.22  Excluded substances.

    The following nonnarcotic substances which may, under the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 301), be lawfully sold over the 
counter without a prescription, are excluded from all schedules pursuant 
to section 201(g) (1) of the Act (21 U.S.C. 811(g) (1)):

                                          Excluded Nonnarcotic Products
----------------------------------------------------------------------------------------------------------------
                                                                                     Controlled       (mg or mg/
            Company                  Trade name         NDC code        Form          substance          ml)
----------------------------------------------------------------------------------------------------------------
Bioline Laboratories...........  Theophed..........      00719-1945  TB          Phenobarbital.....         8.00
Classic Pharmaceuticals LLC....  Nasal Decongestant  ..............  IN          Levmetamfetamine          50.00
                                  Inhaler/Vapor                                   (l-
                                  Inhaler.                                        Desoxyephedrine).
Goldline Laboratories..........  Guiaphed Elixir...      00182-1377  EL          Phenobarbital.....         4.00
Goldline Laboratories..........  Tedrigen Tablets..      00182-0134  TB          Phenobarbital.....         8.00
Hawthorne Products Inc.........  Choate's Leg        ..............  LQ          Chloral hydrate...       246.67
                                  Freeze.
Parke-Davis & Co...............  Tedral............      00071-0230  TB          Phenobarbital.....         8.00
Parke-Davis & Co...............  Tedral Elixir.....      00071-0242  EX          Phenobarbital.....        40.00
Parke-Davis & Co...............  Tedral S.A........      00071-0231  TB          Phenobarbital.....         8.00
Parke-Davis & Co...............  Tedral Suspension.      00071-0237  SU          Phenobarbital.....        80.00
Parmed Pharmacy................  Asma-Ese..........      00349-2018  TB          Phenobarbital.....         8.10
Rondex Labs....................  Azma-Aids.........      00367-3153  TB          Phenobarbital.....         8.00
Smith Kline Consumer...........  Benzedrex.........      49692-0928  IN          Propylhexedrine...       250.00
Sterling Drug, Inc.............  Bronkolixir.......      00057-1004  EL          Phenobarbital.....         0.80
Sterling Drug, Inc.............  Bronkotabs........      00057-1005  TB          Phenobarbital.....         8.00
Vicks Chemical Co..............  Vicks Inhaler.....      23900-0010  IN          I-Desoxyephedrine.       113.00
White Hall Labs................  Primatene (P-           00573-2940  TB          Phenobarbital.....         8.00
                                  tablets).
----------------------------------------------------------------------------------------------------------------


[38 FR 8255, Mar. 30, 1973. Redesignated at 38 FR 26609, Sept. 24, 1973, 
and amended at 41 FR 16553, Apr. 20, 1976; 41 FR 53477, Dec. 7, 1976; 46 
FR 51603, Oct. 21, 1981; 47 FR 45867, Oct. 14, 1982; 54 FR 2100, Jan. 
19, 1989; 55 FR 12162, Mar. 30, 1990; 62 FR 13968, Mar. 24, 1997; 74 FR 
44283, Aug. 28, 2009]

                      Exempt Chemical Preparations



Sec. 1308.23  Exemption of certain chemical preparations; application.

    (a) The Administrator may, by regulation, exempt from the 
application of all or any part of the Act any chemical preparation or 
mixture containing one or more controlled substances listed in any 
schedule, which preparation or mixture is intended for laboratory, 
industrial, educational, or special research purposes and not for 
general administration to a human being or other animal, if the 
preparation or mixture either:
    (1) Contains no narcotic controlled substance and is packaged in 
such a form or concentration that the packaged quantity does not present 
any significant potential for abuse (the type of packaging and the 
history of abuse of the same or similar preparations may be considered 
in determining the potential for abuse of the preparation or mixture); 
or
    (2) Contains either a narcotic or nonnarcotic controlled substance 
and one or more adulterating or denaturing agents in such a manner, 
combination, quantity, proportion, or concentration, that the 
preparation or mixture does not present any potential for abuse. If the 
preparation or mixture contains a narcotic controlled substance, the 
preparation or mixture must be formulated in such a manner that it 
incorporates methods of denaturing or other means so that the 
preparation or mixture is not liable to be abused or have ill effects, 
if abused, and so that the narcotic substance cannot in practice be 
removed.
    (b) Any person seeking to have any preparation or mixture containing 
a controlled substance and one or more noncontrolled substances exempted 
from the application of all or any part of the Act, pursuant to 
paragraph (a) of this section, may apply to the Office of Diversion 
Control, Drug Enforcement Administration. See the Table of DEA Mailing 
Addresses in Sec. 1321.01 of this chapter for the current mailing 
address.
    (c) An application for an exemption under this section shall contain 
the following information:
    (1) The name, address, and registration number, if any, of the 
applicant;

[[Page 120]]

    (2) The name, address, and registration number, if any, of the 
manufacturer or importer of the preparation or mixture, if not the 
applicant;
    (3) The exact trade name or other designation of the preparation or 
mixture;
    (4) The complete qualitative and quantitative composition of the 
preparation or mixture (including all active and inactive ingredients 
and all controlled and noncontrolled substances);
    (5) The form of the immediate container in which the preparation or 
mixture will be distributed with sufficient descriptive detail to 
identify the preparation or mixture (e.g., bottle, packet, vial, soft 
plastic pillow, agar gel plate, etc.);
    (6) The dimensions or capacity of the immediate container of the 
preparation or mixture;
    (7) The label and labeling, as defined in part 1300 of this chapter, 
of the immediate container and the commercial containers, if any, of the 
preparation or mixture;
    (8) A brief statement of the facts which the applicant believes 
justify the granting of an exemption under this paragraph, including 
information on the use to which the preparation or mixture will be put;
    (9) The date of the application; and
    (10) Which of the information submitted on the application, if any, 
is deemed by the applicant to be a trade secret or otherwise 
confidential and entitled to protection under subsection 402(a)(8) of 
the Act (21 U.S.C. 842(a) (8)) or any other law restricting public 
disclosure of information.
    (d) The Administrator may require the applicant to submit such 
documents or written statements of fact relevant to the application as 
he deems necessary to determine whether the application should be 
granted.
    (e) Within a reasonable period of time after the receipt of an 
application for an exemption under this section, the Administrator shall 
notify the applicant of his acceptance or nonacceptance of his 
application, and if not accepted, the reason therefor. The Administrator 
need not accept an application for filing if any of the requirements 
prescribed in paragraph (c) or requested pursuant to paragraph (d) is 
lacking or is not set forth as to be readily understood. If the 
applicant desires, he may amend the application to meet the requirements 
of paragraphs (c) and (d) of this section. If the application is 
accepted for filing, the Administrator shall issue and publish in the 
Federal Register his order on the application, which shall include a 
reference to the legal authority under which the order is based. This 
order shall specify the date on which it shall take effect. The 
Administrator shall permit any interested person to file written 
comments on or objections to the order within 60 days of the date of 
publication of his order in the Federal Register. If any such comments 
or objections raise significant issues regarding any finding of fact or 
conclusion of law upon which the order is based, the Administrator shall 
immediately suspend the effectiveness of the order until he may 
reconsider the application in light of the comments and objections 
filed. Thereafter, the Administrator shall reinstate, revoke, or amend 
his original order as he determines appropriate.
    (f) The Administrator may at any time revoke or modify any exemption 
granted pursuant to this section by following the procedures set forth 
in paragraph (e) of this section for handling an application for an 
exemption which has been accepted for filing. The Administrator may also 
modify or revoke the criteria by which exemptions are granted (and 
thereby modify or revoke all preparations and mixtures granted under the 
old criteria) and modify the scope of exemptions at any time.

[38 FR 8254, Mar. 30, 1973. Redesignated at 38 FR 26609, Sept. 24, 1973, 
and amended at 46 FR 28841, May 29, 1981; 62 FR 13968, Mar. 24, 1997; 75 
FR 10678, Mar. 9, 2010]



Sec. 1308.24  Exempt chemical preparations.

    (a) The chemical preparations and mixtures approved pursuant to 
Sec. 1308.23 are exempt from application of sections 302, 303, 305, 
306, 307, 308, 309, 1002, 1003 and 1004 of the Act (21 U.S.C. 822-823, 
825-829, 952-954) and Sec. 1301.74 of this chapter, to the extent 
described in paragraphs (b) to (h) of this section. Substances set forth 
in paragraph (j) of this section shall be exempt from the

[[Page 121]]

application of sections 305, 306, 307, 308, 309, 1002, 1003 and 1004 of 
the Act (21 U.S.C. 825-829, 952-954) and Sec. Sec. 1301.71-1301.73 and 
1301.74 (a), (b), (d), (e) and (f) of this chapter to the extent as 
hereinafter may be provided.
    (b) Registration and security: Any person who manufactures an exempt 
chemical preparation or mixture must be registered under the Act and 
comply with all relevant security requirements regarding controlled 
substances being used in the manufacturing process until the preparation 
or mixture is in the form described in paragraph (i) of this section. 
Any other person who handles an exempt chemical preparation after it is 
in the form described in paragraph (i) of this section is not required 
to be registered under the Act to handle that preparation, and the 
preparation is not required to be stored in accordance with security 
requirements regarding controlled substances.
    (c) Labeling: In lieu of the requirements set forth in part 1302 of 
this chapter, the label and the labeling of an exempt chemical 
preparation must be prominently marked with its full trade name or other 
description and the name of the manufacturer or supplier as set forth in 
paragraph (i) of this section, in such a way that the product can be 
readily identified as an exempt chemical preparation. The label and 
labeling must also include in a prominent manner the statement ``For 
industrial use only'' or ``For chemical use only'' or ``For in vitro use 
only--not for human or animal use'' or ``Diagnostic reagent--for 
professional use only'' or a comparable statement warning the person 
reading it that human or animal use is not intended. The symbol 
designating the schedule of the controlled substance is not required on 
either the label or the labeling of the exempt chemical preparation, nor 
is it necessary to list all ingredients of the preparation.
    (d) Records and reports: Any person who manufactures an exempt 
chemical preparation or mixture must keep complete and accurate records 
and file all reports required under part 1304 of this chapter regarding 
all controlled substances being used in the manufacturing process until 
the preparation or mixture is in the form described in paragraph (i) of 
this section. In lieu of records and reports required under part 1304 of 
this chapter regarding exempt chemical preparations, the manufacturer 
need only record the name, address, and registration number, if any, of 
each person to whom the manufacturer distributes any exempt chemical 
preparation. Each importer or exporter of an exempt narcotic chemical 
preparation must submit a semiannual report of the total quantity of 
each substance imported or exported in each calendar half-year within 30 
days of the close of the period to the Drug and Chemical Evaluation 
Section, Drug Enforcement Administration. See the Table of DEA Mailing 
Addresses in Sec. 1321.01 of this chapter for the current mailing 
address. Any other person who handles an exempt chemical preparation 
after it is in the form described in paragraph (i) of this section is 
not required to maintain records or file reports.
    (e) Quotas, order forms, prescriptions, import, export, and 
transshipment requirements: Once an exempt chemical preparation is in 
the form described in paragraph (i) of this section, the requirements 
regarding quotas, order forms, prescriptions, import permits and 
declarations, export permit and declarations, and transshipment and 
intransit permits and declarations do not apply. These requirements do 
apply, however, to any controlled substances used in manufacturing the 
exempt chemical preparation before it is in the form described in 
paragraph (i) of this section.
    (f) Criminal penalties: No exemption granted pursuant to Sec. 
1308.23 affects the criminal liability for illegal manufacture, 
distribution, or possession of controlled substances contained in the 
exempt chemical preparation. Distribution, possession, and use of an 
exempt chemical preparation are lawful for registrants and 
nonregistrants only as long as such distribution, possession, or use is 
intended for laboratory, industrial, or educational purposes and not for 
immediate or subsequent administration to a human being or other animal.
    (g) Bulk materials: For materials exempted in bulk quantities, the 
Administrator may prescribe requirements

[[Page 122]]

other than those set forth in paragraphs (b) through (e) of this section 
on a case-by-case basis.
    (h) Changes in chemical preparations: Any change in the quantitative 
or qualitative composition of the preparation or mixture after the date 
of application, or change in the trade name or other designation of the 
preparation or mixture, set forth in paragraph (i) of this section, 
requires a new application for exemption.
    (i) A listing of exempt chemical preparations may be obtained by 
submitting a written request to the Drug and Chemical Evaluation 
Section, Drug Enforcement Administration. See the Table of DEA Mailing 
Addresses in Sec. 1321.01 of this chapter for the current mailing 
address.
    (j) The following substances are designated as exempt chemical 
preparations for the purposes set forth in this section.
    (1) Chloral. When packaged in a sealed, oxygen-free environment, 
under nitrogen pressure, safeguarded against exposure to the air.
    (2) Emit\R\ Phenobarbital Enzyme Reagent B. In one liter quantities 
each with a 5 ml. retention sample for repackaging as an exempt chemical 
preparation only.

[38 FR 8255, Mar. 30, 1973]

    Editorial Note: For Federal Register citations affecting Sec. 
1308.24, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and at www.fdsys.gov.

          Excluded Veterinary Anabolic Steroid Implant Products



Sec. 1308.25  Exclusion of a veterinary anabolic steroid implant 
product; application.

    (a) Any person seeking to have any anabolic steroid product, which 
is expressly intended for administration through implants to cattle or 
other nonhuman species and which has been approved by the Secretary of 
Health and Human Services for such administration, identified as being 
excluded from any schedule, pursuant to section 102(41)(B)(i) of the Act 
(21 U.S.C. 802(41)(B)(i)), may apply to the Office of Diversion Control, 
Drug Enforcement Administration. See the Table of DEA Mailing Addresses 
in Sec. 1321.01 of this chapter for the current mailing address.
    (b) An application for any exclusion under this section shall be 
submitted in triplicate and contain the following information:
    (1) The name and address of the applicant;
    (2) The name of the product;
    (3) The chemical structural formula or description for any anabolic 
steroid contained in the product;
    (4) A complete description of dosage and quantitative composition of 
the dosage form;.
    (5) The conditions of use including whether or not Federal law 
restricts this product to use by or on the order of a licensed 
veterinarian;
    (6) A description of the delivery system in which the dosage form 
will be distributed with sufficient detail to identify the product (e.g. 
20 cartridge brown plastic belt);
    (7) The label and labeling of the immediate container and the 
commercial containers, if any, of the product;.
    (8) The name and address of the manufacturer of the dosage form if 
different from that of the applicant; and
    (9) Evidence that the product has been approved by the Secretary of 
Health and Human Services for administration through implant to cattle 
or other nonhuman species.
    (c) Within a reasonable period of time after the receipt of an 
application for an exclusion under this section, the Administrator shall 
notify the applicant of his acceptance or nonacceptance of the 
application, and if not accepted, the reason therefore. The 
Administrator need not accept an application for filing if any of the 
requirements prescribed in paragraph (b) of this section is lacking or 
is not set forth as to be readily understood. The applicant may amend 
the application to meet the requirements of paragraph (b) of this 
section. If the application is accepted for filing, the Administrator 
shall issue and have published in the Federal Register his order on the 
application, which shall include a reference to the legal authority 
under which the order is issued and the findings of fact and conclusions 
of law upon which the order is based. This

[[Page 123]]

order shall specify the date on which it will take effect. The 
Administrator shall permit any interested person to file written 
comments on or objections to the order within 60 days of the date of 
publication in the Federal Register. If any such comments or objections 
raise significant issues regarding any finding of fact or conclusion of 
law upon which the order is based, the Administrator shall immediately 
suspend the effectiveness of the order until he may reconsider the 
application in light of the comments and objections filed. Thereafter, 
the Administrator shall reinstate, revoke, or amend his original order 
as he determines appropriate.
    (d) The Administrator may at any time revoke or modify any 
designation of excluded status granted pursuant to this section by 
following the procedures set forth in paragraph (c) of this section for 
handling an application for an exclusion which has been accepted for 
filing.

[56 FR 42936, Aug. 30, 1991, as amended at 75 FR 10679, Mar. 9, 2010]



Sec. 1308.26  Excluded veterinary anabolic steroid implant products.

    (a) Products containing an anabolic steroid, that are expressly 
intended for administration through implants to cattle or other nonhuman 
species and which have been approved by the Secretary of Health and 
Human Services for such administration are excluded from all schedules 
pursuant to section 102(41)(B)(i) of the Act (21 U.S.C. 802(41)(B)(i)). 
A listing of the excluded products may be obtained by submitting a 
written request to the Drug and Chemical Evaluation Section, Drug 
Enforcement Administration. See the Table of DEA Mailing Addresses in 
Sec. 1321.01 of this chapter for the current mailing address.
    (b) In accordance with section 102(41)(B)(ii) of the Act (21 U.S.C. 
802(41)(B)(ii)) if any person prescribes, dispenses, or distributes a 
product listed in paragraph (a) of this section for human use, such 
person shall be considered to have prescribed, dispensed, or distributed 
an anabolic steroid within the meaning of section 102(41)(A) of the Act 
(21 U.S.C. 802(41)(A)).

[56 FR 42936, Aug. 30, 1991, as amended at 57 FR 19534, May 7, 1992; 58 
FR 15088, Mar. 19, 1993; 62 FR 13967, Mar. 24, 1997; 75 FR 10679, Mar. 
9, 2010]

                     Exempted Prescription Products



Sec. 1308.31  Application for exemption of a nonnarcotic prescription 
product.

    (a) Any person seeking to have any compound, mixture, or preparation 
containing any nonnarcotic controlled substance listed in Sec. 
1308.12(e), or in Sec. 1308.13(b) or (c), or in Sec. 1308.14, or in 
Sec. 1308.15, exempted from application of all or any part of the Act 
pursuant to section 201(g)(3)(A), of the Act (21 U.S.C. 811(g)(3)(A)) 
may apply to the Office of Diversion Control, Drug Enforcement 
Administration. See the Table of DEA Mailing Addresses in Sec. 1321.01 
of this chapter for the current mailing address.
    (b) An application for an exemption under this section shall contain 
the following information:
    (1) The complete quantitative composition of the dosage form.
    (2) Description of the unit dosage form together with complete 
labeling.
    (3) A summary of the pharmacology of the product including animal 
investigations and clinical evaluations and studies, with emphasis on 
the psychic and/or physiological dependence liability (this must be done 
for each of the active ingredients separately and for the combination 
product).
    (4) Details of synergisms and antagonisms among ingredients.
    (5) Deterrent effects of the noncontrolled ingredients.
    (6) Complete copies of all literature in support of claims.
    (7) Reported instances of abuse.
    (8) Reported and anticipated adverse effects.
    (9) Number of dosage units produced for the past 2 years.
    (c) Within a reasonable period of time after the receipt of an 
application for an exemption under this section, the Administrator shall 
notify the applicant of his acceptance or non-acceptance of the 
application, and if not

[[Page 124]]

accepted, the reason therefor. The Administrator need not accept an 
application for filing if any of the requirements prescribed in 
paragraph (b) of this section is lacking or is not set forth so as to be 
readily understood. If the applicant desires, he may amend the 
application to meet the requirements of paragraph (b) of this section. 
If accepted for filing, the Administrator shall publish in the Federal 
Register general notice of this proposed rulemaking in granting or 
denying the application. Such notice shall include a reference to the 
legal authority under which the rule is proposed, a statement of the 
proposed rule granting or denying an exemption, and, in the discretion 
of the Administrator, a summary of the subjects and issues involved. The 
Administrator shall permit any interested person to file written 
comments on or objections to the proposal and shall designate in the 
notice of proposed rule making the time during which such filings may be 
made. After consideration of the application and any comments on or 
objections to his proposed rulemaking, the Administrator shall issue and 
publish in the Federal Register his final order on the application, 
which shall set forth the findings of fact and conclusions of law upon 
which the order is based. This order shall specify the date on which it 
shall take effect, which shall not be less than 30 days from the date of 
publication in the Federal Register unless the Administrator finds that 
conditions of public health or safety necessitate an earlier effective 
date, in which event the Administrator shall specify in the order his 
findings as to such conditions.
    (d) The Administrator may revoke any exemption granted pursuant to 
section 201(g)(3)(A) of the Act (21 U.S.C. 811(g)(3)(A)) by following 
the procedures set forth in paragraph (c) of this section for handling 
an application for an exemption which has been accepted for filing.

[38 FR 8254, Mar. 30, 1973. Redesignated at 38 FR 26609, Sept. 24, 1973, 
as amended at 44 FR 18968, Mar. 30, 1979; 52 FR 9803, Mar. 27, 1987; 75 
FR 10679, Mar. 9, 2010]



Sec. 1308.32  Exempted prescription products.

    The compounds, mixtures, or preparations that contain a nonnarcotic 
controlled substance listed in Sec. 1308.12(e) or in Sec. 1308.13(b) 
or (c) or in Sec. 1308.14 or in Sec. 1308.15 listed in the Table of 
Exempted Prescription Products have been exempted by the Administrator 
from the application of sections 302 through 305, 307 through 309, and 
1002 through 1004 of the Act (21 U.S.C. 822-825, 827-829, and 952-954) 
and Sec. Sec. 1301.13, 1301.22, and Sec. Sec. 1301.71 through 1301.76 
of this chapter for administrative purposes only. An exception to the 
above is that those products containing butalbital shall not be exempt 
from the requirement of 21 U.S.C. 952-954 concerning importation, 
exportation, transshipment and in-transit shipment of controlled 
substances. Any deviation from the quantitative composition of any of 
the listed drugs shall require a petition of exemption in order for the 
product to be exempted. A listing of the Exempted Prescription Products 
may be obtained by submitting a written request to the Drug and Chemical 
Evaluation Section, Drug Enforcement Administration. See the Table of 
DEA Mailing Addresses in Sec. 1321.01 of this chapter for the current 
mailing address.

[75 FR 10679, Mar. 9, 2010]

                    Exempt Anabolic Steroid Products



Sec. 1308.33  Exemption of certain anabolic steroid products; 
application.

    (a) The Administrator, upon the recommendation of Secretary of 
Health and Human Services, may, by regulation, exempt from the 
application of all or any part of the Act any compound, mixture, or 
preparation containing an anabolic steroid as defined in part 1300 of 
this chapter, which is intended for administration to a human being or 
animal, if, because of its concentration, preparation, formulation, or 
delivery system, it has no significant potential for abuse.
    (b) Any person seeking to have any compound, mixture, or preparation 
containing an anabolic steroid as defined in part 1300 of this chapter 
exempted from the application of all or

[[Page 125]]

any part of the Act, pursuant to paragraph (a) of this section, may 
apply to the Office of Diversion Control, Drug Enforcement 
Administration. See the Table of DEA Mailing Addresses in Sec. 1321.01 
of this chapter for the current mailing address.
    (c) An application for an exemption under this section shall be 
submitted in triplicate and contain the following information:
    (1) The name and address of the applicant;
    (2) The name of the product;
    (3) The chemical structural formula or description for any anabolic 
steroid contained in the product;
    (4) The complete description of dosage and quantitative composition 
of the dosage form;
    (5) A description of the delivery system, if applicable;
    (6) The indications and conditions for use in which species, 
including whether or not this product is a prescription drug;
    (7) Information to facilitate identification of the dosage form, 
such as shape, color, coating, and scoring;
    (8) The label and labeling of the immediate container and the 
commercial containers, if any, of the product;
    (9) The units in which the dosage form is ordinarily available; and
    (10) The facts which the applicant believes justify:
    (i) A determination that the product has no significant potential 
for abuse and
    (ii) a granting of an exemption under this section.
    (d) Within a reasonable period of time after the receipt of the 
application for an exemption under this section, the Administrator shall 
notify the applicant of his acceptance or nonacceptance of the 
application, and if not accepted, the reason therefor. The Administrator 
need not accept an application for filing if any of the requirements 
prescribed in paragraph (c) of this section is lacking or is not set 
forth so as to be readily understood. The applicant may amend the 
application to meet the requirements of paragraph (c) of this section. 
If accepted for filing, the Administrator will request from the 
Secretary for Health and Human Services his recommendation, as to 
whether such product which contains an anabolic steroid should be 
considered for exemption from certain portions of the Controlled 
Substances Act. On receipt of the recommendation of the Secretary, the 
Administrator shall make a determination as to whether the evidence 
submitted or otherwise available sufficiently establishes that the 
product possesses no significant potential for abuse. The Administrator 
shall issue and publish in the Federal Register his order on the 
application, which shall include a reference to the legal authority 
under which the order is issued, and the findings of fact and 
conclusions of law upon which the order is based. This order shall 
specify the date on which it will take effect. The Administrator shall 
permit any interested person to file written comments on or objections 
to the order within 60 days of the date of publication of his order in 
the Federal Register. If any such comments or objections raise 
significant issues regarding any finding of fact or conclusion of law 
upon which the order is based, the Administrator shall immediately 
suspend the effectiveness of the order until he may reconsider the 
application in light of the comments and objections filed. Thereafter, 
the Administrator shall reinstate, revoke, or amend his original order 
as he determines appropriate.
    (e) The Administrator may revoke any exemption granted pursuant to 
section 1903(a) of Public Law 101-647 by following the procedures set 
forth in paragraph (d) of this section for handling an application for 
an exemption which has been accepted for filing.

[56 FR 42936, Aug. 30, 1991; 57 FR 10815, Mar. 31, 1992, as amended at 
62 FR 13968, Mar. 24, 1997; 70 FR 74657, Dec. 16, 2005; 75 FR 10679, 
Mar. 9, 2010]



Sec. 1308.34  Exempt anabolic steroid products.

    The list of compounds, mixtures, or preparations that contain an 
anabolic steroid that have been exempted by the Administrator from 
application of sections 302 through 309 and 1002 through 1004 of the Act 
(21 U.S.C. 822-829 and 952-954) and Sec. Sec. 1301.13, 1301.22, and 
1301.71 through 1301.76 of this chapter for administrative purposes only 
may

[[Page 126]]

be obtained by submitting a written request to the Drug and Chemical 
Evaluation Section, Drug Enforcement Administration. See the Table of 
DEA Mailing Addresses in Sec. 1321.01 of this chapter for the current 
mailing address.

[75 FR 10679, Mar. 9, 2010]

   Exempt Cannabis Plant Material, and Products Made Therefrom, that 
                      Contain Tetrahydrocannabinols



Sec. 1308.35  Exemption of certain cannabis plant material, and 
products made therefrom, that contain tetrahydrocannabinols.

    (a) Any processed plant material or animal feed mixture containing 
any amount of tetrahydrocannabinols (THC) that is both:
    (1) Made from any portion of a plant of the genus Cannabis excluded 
from the definition of marijuana under the Act [i.e., the mature stalks 
of such plant, fiber produced from such stalks, oil or cake made from 
the seeds of such plant, any other compound, manufacture, salt, 
derivative, mixture, or preparation of such mature stalks (except the 
resin extracted therefrom), fiber, oil, or cake, or the sterilized seed 
of such plant which is incapable of germination] and
    (2) Not used, or intended for use, for human consumption, has been 
exempted by the Administrator from the application of the Act and this 
chapter.
    (b) As used in this section, the following terms shall have the 
meanings specified:
    (1) The term processed plant material means cannabis plant material 
that has been subject to industrial processes, or mixed with other 
ingredients, such that it cannot readily be converted into any form that 
can be used for human consumption.
    (2) The term animal feed mixture means sterilized cannabis seeds 
mixed with other ingredients (not derived from the cannabis plant) in a 
formulation that is designed, marketed, and distributed for animal 
consumption (and not for human consumption).
    (3) The term used for human consumption means either:
    (i) Ingested orally or
    (ii) Applied by any means such that THC enters the human body.
    (4) The term intended for use for human consumption means any of the 
following:
    (i) Designed by the manufacturer for human consumption;
    (ii) Marketed for human consumption; or
    (iii) Distributed, exported, or imported, with the intent that it be 
used for human consumption.
    (c) In any proceeding arising under the Act or this chapter, the 
burden of going forward with the evidence that a material, compound, 
mixture, or preparation containing THC is exempt from control pursuant 
to this section shall be upon the person claiming such exemption, as set 
forth in section 515(a)(1) of the Act (21 U.S.C. 885(a)(1)). In order to 
meet this burden with respect to a product or plant material that has 
not been expressly exempted from control by the Administrator pursuant 
to Sec. 1308.23, the person claiming the exemption must present 
rigorous scientific evidence, including well-documented scientific 
studies by experts trained and qualified to evaluate the effects of 
drugs on humans.

[66 FR 51544, Oct. 9, 2001]

                                Hearings



Sec. 1308.41  Hearings generally.

    In any case where the Administrator shall hold a hearing on the 
issuance, amendment, or repeal of rules pursuant to section 201 of the 
Act, the procedures for such hearing and accompanying proceedings shall 
be governed generally by the rulemaking procedures set forth in the 
Administrative Procedure Act (5 U.S.C. 551-559) and specifically by 
section 201 of the Act (21 U.S.C. 811), by Sec. Sec. 1308.42-1308.51, 
and by Sec. Sec. 1316.41-1316.67 of this chapter.



Sec. 1308.42  Purpose of hearing.

    If requested by any interested person after proceedings are 
initiated pursuant to Sec. 1308.43, the Administrator shall hold a 
hearing for the purpose of receiving factual evidence and expert opinion 
regarding the issues involved in the issuance, amendment or repeal of a 
rule issuable pursuant to section

[[Page 127]]

201(a) of the Act (21 U.S.C. 811(a)). Extensive argument should not be 
offered into evidence but rather presented in opening or closing 
statements of counsel or in memoranda or proposed findings of fact and 
conclusions of law. Additional information relating to hearings to 
include waivers or modification of rules, request for hearing, burden of 
proof, time and place, and final order are set forth in part 1316 of 
this chapter.

[62 FR 13968, Mar. 24, 1997]



Sec. 1308.43  Initiation of proceedings for rulemaking.

    (a) Any interested person may submit a petition to initiate 
proceedings for the issuance, amendment, or repeal of any rule or 
regulation issuable pursuant to the provisions of section 201 of the 
Act.
    (b) Petitions shall be submitted in quintuplicate to the 
Administrator. See the Table of DEA Mailing Addresses in Sec. 1321.01 
of this chapter for the current mailing address. Petitions shall be in 
the following form:

-------------------- (Date)
Administrator, Drug Enforcement Administration ------------ (Mailing 
Address)

    Dear Sir: The undersigned ---------------- hereby petitions the 
Administrator to initiate proceedings for the issuance (amendment or 
repeal) of a rule or regulation pursuant to section 201 of the 
Controlled Substances Act.
    Attached hereto and constituting a part of this petition are the 
following:
    (A) The proposed rule in the form proposed by the petitioner. (If 
the petitioner seeks the amendment or repeal of an existing rule, the 
existing rule, together with a reference to the section in the Code of 
Federal Regulations where it appears, should be included.)
    (B) A statement of the grounds which the petitioner relies for the 
issuance (amendment or repeal) of the rule. (Such grounds shall include 
a reasonably concise statement of the facts relied upon by the 
petitioner, including a summary of any relevant medical or scientific 
evidence known to the petitioner.)
    All notices to be sent regarding this petition should be addressed 
to:
-------------------- (Name)
-------------------- (Street Address)
-------------------- (City and State)
    Respectfully yours,
-------------------- (Signature of petitioner)

    (c) Within a reasonable period of time after the receipt of a 
petition, the Administrator shall notify the petitioner of his 
acceptance or nonacceptance of the petition, and if not accepted, the 
reason therefor. The Administrator need not accept a petition for filing 
if any of the requirements prescribed in paragraph (b) of this section 
is lacking or is not set forth so as to be readily understood. If the 
petitioner desires, he may amend the petition to meet the requirements 
of paragraph (b) of this section. If accepted for filing, a petition may 
be denied by the Administrator within a reasonable period of time 
thereafter if he finds the grounds upon which the petitioner relies are 
not sufficient to justify the initiation of proceedings.
    (d) The Administrator shall, before initiating proceedings for the 
issuance, amendment, or repeal of any rule either to control a drug or 
other substance, or to transfer a drug or other substance from one 
schedule to another, or to remove a drug or other substance entirely 
from the schedules, and after gathering the necessary data, request from 
the Secretary a scientific and medical evaluation and the Secretary's 
recommendations as to whether such drug or other substance should be so 
controlled, transferred, or removed as a controlled substance. The 
recommendations of the Secretary to the Administrator shall be binding 
on the Administrator as to such scientific and medical matters, and if 
the Secretary recommends that a drug or other substance not be 
controlled, the Administrator shall not control that drug or other 
substance.
    (e) If the Administrator determines that the scientific and medical 
evaluation and recommendations of the Secretary and all other relevant 
data constitute substantial evidence of potential for abuse such as to 
warrant control or additional control over the drug or other substance, 
or substantial evidence that the drug or other substances should be 
subjected to lesser control or removed entirely from the schedules, he 
shall initiate proceedings for control, transfer, or removal as the case 
may be.
    (f) If and when the Administrator determines to initiate 
proceedings, he

[[Page 128]]

shall publish in the Federal Register general notice of any proposed 
rule making to issue, amend, or repeal any rule pursuant to section 201 
of the Act. Such published notice shall include a statement of the time, 
place, and nature of any hearings on the proposal in the event a hearing 
is requested pursuant to Sec. 1308.44. Such hearings may not be 
commenced until after the expiration of at least 30 days from the date 
the general notice is published in the Federal Register. Such published 
notice shall also include a reference to the legal authority under which 
the rule is proposed, a statement of the proposed rule, and, in the 
discretion of the Administrator, a summary of the subjects and issues 
involved.
    (g) The Administrator may permit any interested persons to file 
written comments on or objections to the proposal and shall designate in 
the notice of proposed rule making the time during which such filings 
may be made.

[38 FR 8254, Mar. 30, 1973. Redesignated at 38 FR 26609, Sept. 24, 1973, 
and further redesignated and amended at 62 FR 13968, Mar. 24, 1997; 75 
FR 10679, Mar. 9, 2010]



Sec. 1308.44  Request for hearing or appearance; waiver.

    (a) Any interested person desiring a hearing on a proposed 
rulemaking, shall, within 30 days after the date of publication of 
notice of the proposed rulemaking in the Federal Register, file with the 
Administrator a written request for a hearing in the form prescribed in 
Sec. 1316.47 of this chapter.
    (b) Any interested person desiring to participate in a hearing 
pursuant to Sec. 1308.41 shall, within 30 days after the date of 
publication of the notice of hearing in the Federal Register, file with 
the Administrator a written notice of his intention to participate in 
such hearing in the form prescribed in Sec. 1316.48 of this chapter. 
Any person filing a request for a hearing need not also file a notice of 
appearance; the request for a hearing shall be deemed to be a notice of 
appearance.
    (c) Any interested person may, within the period permitted for 
filing a request for a hearing, file with the Administrator a waiver of 
an opportunity for a hearing or to participate in a hearing, together 
with a written statement regarding his position on the matters of fact 
and law involved in such hearing. Such statement, if admissible, shall 
be made a part of the record and shall be considered in light of the 
lack of opportunity for cross-examination in determining the weight to 
be attached to matters of fact asserted therein.
    (d) If any interested person fails to file a request for a hearing; 
or if he so files and fails to appear at the hearing, he shall be deemed 
to have waived his opportunity for the hearing or to participate in the 
hearing, unless he shows good cause for such failure.
    (e) If all interested persons waive or are deemed to waive their 
opportunity for the hearing or to participate in the hearing, the 
Administrator may cancel the hearing, if scheduled, and issue his final 
order pursuant to Sec. 1308.45 without a hearing.

[38 FR 8254, Mar. 30, 1973. Redesignated at 38 FR 26609, Sept. 24, 1973, 
and further redesignated and amended at 62 FR 13968, Mar. 24, 1997]



Sec. 1308.45  Final order.

    As soon as practicable after the presiding officer has certified the 
record to the Administrator, the Administrator shall cause to be 
published in the Federal Register his order in the proceeding, which 
shall set forth the final rule and the findings of fact and conclusions 
of law upon which the rule is based. This order shall specify the date 
on which it shall take effect, which shall not be less than 30 days from 
the date of publication in the Federal Register unless the Administrator 
finds that conditions of public health or safety necessitate an earlier 
effective date, in which event the Administrator shall specify in the 
order his findings as to such conditions.

[38 FR 8254, Mar. 30, 1973. Redesignated at 38 FR 26609, Sept. 24, 1973, 
and further redesignated at 62 FR 13968, Mar. 24, 1997]



Sec. 1308.46  Control required under international treaty.

    Pursuant to section 201(d) of the Act (21 U.S.C. 811(d)), where 
control of a substance is required by U.S. obligations under 
international treaties, conventions, or protocols in effect on May 1, 
1971, the Administrator shall issue

[[Page 129]]

and publish in the Federal Register an order controlling such substance 
under the schedule he deems most appropriate to carry out obligations. 
Issuance of such an order shall be without regard to the findings 
required by subsections 201(a) or 202(b) of the Act (21 U.S.C. 811(a) or 
812(b)) and without regard to the procedures prescribed by Sec. 1308.41 
or subsections 201 (a) and (b) of the Act (21 U.S.C. 811 (a) and (b)). 
An order controlling a substance shall become effective 30 days from the 
date of publication in the Federal Register, unless the Administrator 
finds that conditions of public health or safety necessitate an earlier 
effective date, in which event the Administrator shall specify in the 
order his findings as to such conditions.

[38 FR 8254, Mar. 30, 1973. Redesignated at 38 FR 26609, Sept. 24, 1973, 
and further redesignated at 62 FR 13968, Mar. 24, 1997]



Sec. 1308.47  Control of immediate precursors.

    Pursuant to section 201(e) of the Act (21 U.S.C. 811(e)), the 
Administrator may, without regard to the findings required by subsection 
201(a) or 202 (b) of the Act (21 U.S.C. 811(a) or 812(b)) and without 
regard to the procedures prescribed by Sec. 1308.41 or subsections 201 
(a) and (b) of the Act (21 U.S.C. 811(a) and (b)), issue and publish in 
the Federal Register an order controlling an immediate precursor. The 
order shall designate the schedule in which the immediate precursor is 
to be placed, which shall be the same schedule in which the controlled 
substance of which it is an immediate precursor is placed or any other 
schedule with a higher numerical designation. An order controlling an 
immediate precursor shall become effective 30 days from the date of 
publication in the Federal Register, unless the Administrator finds that 
conditions of public health or safety necessitate an earlier effective 
date, in which event the Administrator shall specify in the order his 
findings as to such conditions.

[38 FR 8254, Mar. 30, 1973. Redesignated at 38 FR 26609, Sept. 24, 1973, 
and further redesignated at 62 FR 13968, Mar. 24, 1997]



Sec. 1308.49  Emergency scheduling.

    Pursuant to 21 U.S.C. 811(h) and without regard to the requirements 
of 21 U.S.C. 811(b) relating to the scientific and medical evaluation of 
the Secretary of Health and Human Services, the Administrator may place 
a substance into Schedule I on a temporary basis, if he determines that 
such action is necessary to avoid an imminent hazard to the public 
safety. An order issued under this section may not be effective before 
the expiration of 30 days from:
    (a) The date of publication by the Administrator of a notice in the 
Federal Register of his intention to issue such order and the grounds 
upon which such order is to be issued, and
    (b) The date the Administrator has transmitted notification to the 
Secretary of Health and Human Services of his intention to issue such 
order. An order issued under this section shall be vacated upon the 
conclusion of a subsequent rulemaking proceeding initiated under section 
201(a) (21 U.S.C. 811(a)) with respect to such substance or at the end 
of one year from the effective date of the order scheduling the 
substance, except that during the pendency of proceedings under section 
201(a) (21 U.S.C. 811(a)) with respect to the substance, the 
Administrator may extend the temporary scheduling for up to six months.

[51 FR 15318, Apr. 23, 1986. Redesignated and amended at 62 FR 13968, 
Mar. 24, 1997]



PART 1309_REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, IMPORTERS AND
EXPORTERS OF LIST I CHEMICALS--Table of Contents



                           General Information

Sec.
1309.01 Scope of part 1309.
1309.02 Definitions.
1309.03 Information; special instructions.

                Fees for Registration and Reregistration

1309.11 Fee amounts.
1309.12 Time and method of payment; refund.

                      Requirements for Registration

1309.21 Persons required to register.
1309.22 Separate registration for independent activities.

[[Page 130]]

1309.23 Separate registration for separate locations.
1309.24 Waiver of registration requirement for certain activities.
1309.25 Temporary exemption from registration for chemical registration 
          applicants.
1309.26 Exemption of law enforcement officials.

                      Application for Registration

1309.31 Time for application for registration; expiration date.
1309.32 Application forms; contents, signature.
1309.33 Filing of application; joint filings.
1309.34 Acceptance for filing; defective applications.
1309.35 Additional information.
1309.36 Amendments to and withdrawals of applications.

  Action on Applications for Registration: Revocation or Suspension of 
                              Registration

1309.41 Administrative review generally.
1309.42 Certificate of registration; denial of registration.
1309.43 Suspension or revocation of registration.
1309.44 Suspension of registration pending final order.
1309.45 Extension of registration pending final order.
1309.46 Order to show cause.

                                Hearings

1309.51 Hearings generally.
1309.52 Purpose of hearing.
1309.53 Request for hearing or appearance; waiver.
1309.54 Burden of proof.
1309.55 Time and place of hearing.

         Modification, Transfer and Termination of Registration

1309.61 Modification in registration.
1309.62 Termination of registration.
1309.63 Transfer of registration.

                          Security Requirements

1309.71 General security requirements.
1309.72 Felony conviction; employer responsibilities.
1309.73 Employee responsibility to report diversion.

    Authority: 21 U.S.C. 802, 821, 822, 823, 824, 830, 871(b), 875, 877, 
886a, 952, 953, 957, 958.

    Source: 60 FR 32454, June 22, 1995, unless otherwise noted.

                           General Information



Sec. 1309.01  Scope of part 1309.

    Procedures governing the registration of manufacturers, 
distributors, importers and exporters of List I chemicals pursuant to 
Sections 102, 302, 303, 1007 and 1008 of the Act (21 U.S.C. 802, 822, 
823, 957 and 958) are set forth generally by those sections and 
specifically by the sections of this part.



Sec. 1309.02  Definitions.

    Any term used in this part shall have the definition set forth in 
section 102 of the Act (21 U.S.C. 802) or part 1300 of this chapter.

[62 FR 13968, Mar. 24, 1997]



Sec. 1309.03  Information; special instructions.

    Information regarding procedures under these rules and instructions 
supplementing these rules will be furnished upon request by writing to 
the Registration Section, Drug Enforcement Administration. See the Table 
of DEA Mailing Addresses in Sec. 1321.01 of this chapter for the 
current mailing address.

[75 FR 10680, Mar. 9, 2010]

                Fees for Registration and Reregistration



Sec. 1309.11  Fee amounts.

    (a) For each application for registration or reregistration to 
manufacture the applicant shall pay an annual fee of $3,047.
    (b) For each application for registration or reregistration to 
distribute, import, or export a List I chemical, the applicant shall pay 
an annual fee of $1,523.

[77 FR 15250, Mar. 15, 2012]



Sec. 1309.12  Time and method of payment; refund.

    (a) For each application for registration or reregistration to 
manufacture, distribute, import, or export, the applicant shall pay the 
fee when the application for registration or reregistration is submitted 
for filing.
    (b) Payments should be made in the form of a credit card; a 
personal, certified, or cashier's check; or a money order made payable 
to ``Drug Enforcement Administration.'' Payments made in the form of 
stamps, foreign currency, or third party endorsed

[[Page 131]]

checks will not be accepted. These application fees are not refundable.

[75 FR 4980, Feb. 1, 2010]

                      Requirements for Registration



Sec. 1309.21  Persons required to register.

    (a) Unless exempted by law or under Sec. Sec. 1309.24 through 
1309.26 or Sec. Sec. 1310.12 through 1310.13 of this chapter, the 
following persons must annually obtain a registration specific to the 
List I chemicals to be handled:
    (1) Every person who manufactures or imports or proposes to 
manufacture or import a List I chemical or a drug product containing 
ephedrine, pseudoephedrine, or phenylpropanolamine.
    (2) Every person who distributes or exports or proposes to 
distribute or export any List I chemical, other than those List I 
chemicals contained in a product exempted under paragraph (1)(iv) of the 
definition of regulated transaction in Sec. 1300.02 of this chapter.
    (b) Only persons actually engaged in the activities are required to 
obtain a registration; related or affiliated persons who are not engaged 
in the activities are not required to be registered. (For example, a 
stockholder or parent corporation of a corporation distributing List I 
chemicals is not required to obtain a registration.)
    (c) The registration requirements are summarized in the following 
table:

                              Summary of Registration Requirements and Limitations
----------------------------------------------------------------------------------------------------------------
                                                                                   Registration     Coincident
      Business activity            Chemicals         DEA Forms       Application      period        activities
                                                                         fee          (years)        allowed
----------------------------------------------------------------------------------------------------------------
Manufacturing................  List I..........  New-510.........          $3,047             1  May distribute
                                                                                                  that chemical
                                                                                                  for which
                                                                                                  registration
                                                                                                  was issued;
                                                                                                  may not
                                                                                                  distribute any
                                                                                                  chemical for
                                                                                                  which not
                                                                                                  registered.
                               Drug products     Renewal-510a....           3,047
                                containing
                                ephedrine,
                                pseudoephedrine
                                ,
                                phenylpropanola
                                mine.
Distributing.................  List I..........  New-510.........           1,523             1
                               Scheduled listed  Renewal-510a....           1,523
                                chemical
                                products.
Importing....................  List I..........  New-510.........           1,523             1  May distribute
                                                                                                  that chemical
                                                                                                  for which
                                                                                                  registration
                                                                                                  was issued;
                                                                                                  may not
                                                                                                  distribute any
                                                                                                  chemical for
                                                                                                  which not
                                                                                                  registered.
                               Drug Products     Renewal-510a....           1,523
                                containing
                                ephedrine,
                                pseudoephedrine
                                ,
                                phenylpropanola
                                mine.
Exporting....................  List I..........  New-510.........           1,523             1
                               Scheduled listed  Renewal-510a....           1,523
                                chemical
                                products.
----------------------------------------------------------------------------------------------------------------


[75 FR 4980, Feb. 1, 2010, as amended at 77 FR 4236, Jan. 27, 2012; 77 
FR 15250, Mar. 15, 2012]



Sec. 1309.22  Separate registration for independent activities.

    (a) The following groups of activities are deemed to be independent 
of each other:
    (1) Manufacturing of List I chemicals or drug products containing 
ephedrine, pseudoephedrine, or phenylpropanolamine.
    (2) Distributing of List I chemicals and scheduled listed chemical 
products.
    (3) Importing List I chemicals or drug products containing 
ephedrine, pseudoephedrine, or phenylpropanolamine.
    (4) Exporting List I chemicals and scheduled listed chemical 
products.
    (b) Except as provided in paragraphs (c) and (d) of this section, 
every person who engages in more than one group of independent 
activities must obtain a

[[Page 132]]

separate registration for each group of activities, unless otherwise 
exempted by the Act or Sec. Sec. 1309.24 through 1309.26.
    (c) A person registered to import any List I chemical shall be 
authorized to distribute that List I chemical after importation, but no 
other chemical that the person is not registered to import.
    (d) A person registered to manufacture any List I chemical shall be 
authorized to distribute that List I chemical after manufacture, but no 
other chemical that the person is not registered to manufacture.

[75 FR 4981, Feb. 1, 2010]



Sec. 1309.23  Separate registration for separate locations.

    (a) A separate registration is required for each principal place of 
business at one general physical location where List I chemicals are 
manufactured, distributed, imported, or exported by a person.
    (b) The following locations shall be deemed to be places not subject 
to the registration requirement:
    (1) A warehouse where List I chemicals are stored by or on behalf of 
a registered person, unless such chemicals are distributed directly from 
such warehouse to locations other than the registered location from 
which the chemicals were originally delivered; and
    (2) An office used by agents of a registrant where sales of List I 
chemicals are solicited, made, or supervised but which neither contains 
such chemicals (other than chemicals for display purposes) nor serves as 
a distribution point for filling sales orders.

[60 FR 32454, June 22, 1995, as amended at 75 FR 4981, Feb. 1, 2010]



Sec. 1309.24  Waiver of registration requirement for certain activities.

    (a) The requirement of registration is waived for any agent or 
employee of a person who is registered to engage in any group of 
independent activities, if the agent or employee is acting in the usual 
course of his or her business or employment.
    (b) The requirement of registration is waived for any person who 
manufactures or distributes a scheduled listed chemical product or other 
product containing a List I chemical that is described and included in 
paragraph (1)(iv) of the definition of regulated transaction in Sec. 
1300.02 of this chapter, if that person is registered with the 
Administration to engage in the same activity with a controlled 
substance.
    (c) The requirement of registration is waived for any person who 
imports or exports a scheduled listed chemical product or other product 
containing a List I chemical that is described and included in paragraph 
(1)(iv) of the definition of regulated transaction in Sec. 1300.02 of 
this chapter, if that person is registered with the Administration to 
engage in the same activity with a controlled substance.
    (d) The requirement of registration is waived for any person who 
only distributes a prescription drug product containing a List I 
chemical that is regulated pursuant to paragraph (1)(iv) of the 
definition of regulated transaction in Sec. 1300.02 of this chapter.
    (e) The requirement of registration is waived for any person whose 
activities with respect to List I chemicals are limited to the 
distribution of red phosphorus, white phosphorus, or hypophosphorous 
acid (and its salts) to another location operated by the same firm 
solely for internal end-use, or an EPA or State licensed waste treatment 
or disposal firm for the purpose of waste disposal.
    (f) The requirement of registration is waived for any person whose 
distribution of red phosphorus or white phosphorus is limited solely to 
residual quantities of chemical returned to the producer, in reusable 
rail cars and intermodal tank containers which conform to International 
Standards Organization specifications (with capacities greater than or 
equal to 2,500 gallons in a single container).
    (g) The requirement of registration is waived for any person whose 
activities with respect to List I chemicals are limited solely to the 
distribution of Lugol's Solution (consisting of 5 percent iodine and 10 
percent potassium iodide in an aqueous solution) in original 
manufacturer's packaging of one fluid ounce (30 ml) or less.
    (h) The requirement of registration is waived for any manufacturer 
of a List

[[Page 133]]

I chemical, if that chemical is produced solely for internal consumption 
by the manufacturer and there is no subsequent distribution or 
exportation of the List I chemical.
    (i) If any person exempted under paragraph (b), (c), (d), (e), or 
(f) of this section also engages in the distribution, importation, or 
exportation of a List I chemical, other than as described in such 
paragraph, the person shall obtain a registration for the activities, as 
required by Sec. 1309.21.
    (j) The Administrator may, upon finding that continuation of the 
waiver would not be in the public interest, suspend or revoke a waiver 
granted under paragraph (b), (c), (d), (e), or (f) of this section 
pursuant to the procedures set forth in Sec. Sec. 1309.43 through 
1309.46 and Sec. Sec. 1309.51 through 1309.55. In considering the 
revocation or suspension of a person's waiver granted pursuant to 
paragraph (b) or (c) of this section, the Administrator shall also 
consider whether action to revoke or suspend the person's controlled 
substance registration pursuant to section 304 of the Act (21 U.S.C. 
824) is warranted.
    (k) Any person exempted from the registration requirement under this 
section must comply with the security requirements set forth in 
Sec. Sec. 1309.71 through 1309.73 and the recordkeeping and reporting 
requirements set forth under Parts 1310, 1313, 1314, and 1315 of this 
chapter.

[75 FR 4981, Feb. 1, 2010, as amended at 77 FR 4236, Jan. 25, 2012]



Sec. 1309.25  Temporary exemption from registration for chemical 
registration applicants.

    (a) Each person required by section 302 of the Act (21 U.S.C. 822) 
to obtain a registration to distribute, import, or export a combination 
ephedrine product is temporarily exempted from the registration 
requirement, provided that the person submits a proper application for 
registration on or before July 12, 1997. The exemption will remain in 
effect for each person who has made such application until the 
Administration has approved or denied that application. This exemption 
applies only to registration; all other chemical control requirements 
set forth in this part 1309 and parts 1310, and 1313 of this chapter 
remain in full force and effect.
    (b) Each person required by section 302 of the Act (21 U.S.C. 822) 
to obtain a registration to distribute, import, or export a 
pseudoephedrine or phenylpropanolamine drug product is temporarily 
exempted from the registration requirement, provided that the person 
submits a proper application for registration on or before October 3, 
1997. The exemption will remain in effect for each person who has made 
such application until the Administration has approved or denied that 
application. This exemption applies only to registration; all other 
chemical control requirements set forth in this part 1309 and parts 1310 
and 1313 of this chapter remain in full force and effect.
    (c) Each person required by sections 302 or 1007 of the Act (21 
U.S.C. 822 or 957) to obtain a registration to manufacture or import 
prescription drug products containing ephedrine, pseudoephedrine, or 
phenylpropanolamine is temporarily exempted from the registration 
requirement, provided that the person submits a proper application for 
registration on or before March 3, 2010. The exemption will remain in 
effect for each person who has made such application until the 
Administration has approved or denied the application. This exemption 
applies only to registration; all other chemical control requirements 
set forth in this part and parts 1310, 1313, and 1315 of this chapter 
remain in full force and effect.

[67 FR 14860, Mar. 28, 2002, as amended at 75 FR 4982, Feb. 1, 2010]



Sec. 1309.26  Exemption of law enforcement officials.

    (a) The requirement of registration is waived for the following 
persons in the circumstances described in this section:
    (1) Any officer or employee of the Administration, any officer of 
the U.S. Customs Service, any officer or employee of the United States 
Food and Drug Administration, any other Federal officer who is lawfully 
engaged in the enforcement of any Federal law relating to listed 
chemicals, controlled substances, drugs or customs, and is

[[Page 134]]

duly authorized to possess and distribute List I chemicals in the course 
of official duties; and
    (2) Any officer or employee of any State, or any political 
subdivision or agency thereof, who is engaged in the enforcement of any 
State or local law relating to listed chemicals and controlled 
substances and is duly authorized to possess and distribute List I 
chemicals in the course of his official duties.
    (b) Any official exempted by this section may, when acting in the 
course of official duties, possess any List I chemical and distribute 
any such chemical to any other official who is also exempted by this 
section and acting in the course of official duties.

                      Application for Registration



Sec. 1309.31  Time for application for registration; expiration date.

    (a) Any person who is required to be registered and who is not so 
registered may apply for registration at any time. No person required to 
be registered shall engage in any activity for which registration is 
required until the application for registration is approved and a 
Certificate of Registration is issued by the Administrator to such 
person.
    (b) Any person who is registered may apply to be reregistered not 
more than 60 days before the expiration date of his registration.
    (c) At the time a person is first registered, that person shall be 
assigned to one of twelve groups, which shall correspond to the months 
of the year. The expiration date of the registrations of all registrants 
within any group will be the last day of the month designated for that 
group. In assigning any of the above persons to a group, the 
Administration may select a group the expiration date of which is less 
than one year from the date such business activity was registered. If 
the person is assigned to a group which has an expiration date less than 
eleven months from the date of which the person is registered, the 
registration shall not expire until one year from that expiration date; 
in all other cases, the registration shall expire on the expiration date 
following the date on which the person is registered.



Sec. 1309.32  Application forms; contents; signature.

    (a) Any person who is required to be registered pursuant to Sec. 
1309.21 and is not so registered, shall apply on DEA Form 510.
    (b) Any person who is registered pursuant to Section 1309.21, shall 
apply for reregistration on DEA Form 510a.
    (c) DEA Form 510 may be obtained at any divisional office of the 
Administration or by writing to the Registration Section, Drug 
Enforcement Administration. See the Table of DEA Mailing Addresses in 
Sec. 1321.01 of this chapter for the current mailing address. DEA Form 
510a will be mailed to each List I chemical registrant approximately 60 
days before the expiration date of his or her registration; if any 
registered person does not receive such forms within 45 days before the 
expiration date of the registration, notice must be promptly given of 
such fact and DEA Form 510a must be requested by writing to the 
Registration Section of the Administration at the foregoing address.
    (d) Each application for registration shall include the 
Administration Chemical Code Number, as set forth in Sec. 1310.02 of 
this chapter, for each List I chemical to be distributed, imported, or 
exported.
    (e) Registration shall not entitle a person to engage in any 
activity with any List I chemical not specified in his or her 
application.
    (f) Each application shall include all information called for in the 
form, unless the item is not applicable, in which case this fact shall 
be indicated.
    (g) Each application, attachment, or other document filed as part of 
an application, shall be signed by the applicant, if an individual; by a 
partner of the applicant, if a partnership; or by an officer of the 
applicant, if a corporation, corporate division, association, trust or 
other entity. An applicant may authorize one or more individuals, who 
would not otherwise be authorized to do so, to sign applications for the 
applicant by filing with the application or other document a power of 
attorney for each such individual. The power of attorney shall be signed 
by a person who is authorized to sign applications under this paragraph 
and shall contain

[[Page 135]]

the signature of the individual being authorized to sign the application 
or other document. The power of attorney shall be valid until revoked by 
the applicant.

[60 FR 32454, June 22, 1995, as amended at 75 FR 10680, Mar. 9, 2010]



Sec. 1309.33  Filing of application; joint filings.

    (a) All applications for registration shall be submitted for filing 
to the Registration Section, Drug Enforcement Administration. See the 
Table of DEA Mailing Addresses in Sec. 1321.01 of this chapter for the 
current mailing address. The appropriate registration fee and any 
required attachments must accompany the application.
    (b) Any person required to obtain more than one registration may 
submit all applications in one package. Each application must be 
complete and must not refer to any accompanying application for required 
information.

[60 FR 32454, June 22, 1995, as amended at 75 FR 10680, Mar. 9, 2010]



Sec. 1309.34  Acceptance for filing; defective applications.

    (a) Applications submitted for filing are dated upon receipt. If 
found to be complete, the application will be accepted for filing. 
Applications failing to comply with the requirements of this part will 
not generally be accepted for filing. In the case of minor defects as to 
completeness, the Administrator may accept the application for filing 
with a request to the applicant for additional information. A defective 
application will be returned to the applicant within 10 days of receipt 
with a statement of the reason for not accepting the application for 
filing. A defective application may be corrected and resubmitted for 
filing at any time.
    (b) Accepting an application for filing does not preclude any 
subsequent request for additional information pursuant to Sec. 1309.35 
and has no bearing on whether the application will be granted.



Sec. 1309.35  Additional information.

    The Administrator may require an applicant to submit such documents 
or written statements of fact relevant to the application as he deems 
necessary to determine whether the application should be granted. The 
failure of the applicant to provide such documents or statements within 
a reasonable time after being requested to do so shall be deemed to be a 
waiver by the applicant of an opportunity to present such documents or 
facts for consideration by the Administrator in granting or denying the 
application.



Sec. 1309.36  Amendments to and withdrawals of applications.

    (a) An application may be amended or withdrawn without permission of 
the Administration at any time before the date on which the applicant 
receives an order to show cause pursuant to Sec. 1309.46. An 
application may be amended or withdrawn with permission of the 
Administrator at any time where good cause is shown by the applicant or 
where the amendment or withdrawal is in the public interest.
    (b) After an application has been accepted for filing, the request 
by the applicant that it be returned or the failure of the applicant to 
respond to official correspondence regarding the application, including 
a request that the applicant submit the required fee, when sent by 
registered or certified mail, return receipt requested, shall be deemed 
to be a withdrawal of the application.

  Action on Applications for Registration: Revocation or Suspension of 
                              Registration



Sec. 1309.41  Administrative review generally.

    The Administrator may inspect, or cause to be inspected, the 
establishment of an applicant or registrant, pursuant to subpart A of 
part 1316 of this chapter. The Administrator shall review the 
application for registration and other information gathered by the 
Administrator regarding an applicant in order to determine whether the 
applicable standards of Section 303 of the Act (21 U.S.C. 823) have been 
met by the applicant.

[[Page 136]]



Sec. 1309.42  Certificate of registration; denial of registration.

    (a) The Administrator shall issue a Certificate of Registration (DEA 
Form 511) to an applicant if the issuance of registration or 
reregistration is required under the applicable provisions of section 
303 of the Act (21 U.S.C. 823). In the event that the issuance of 
registration or reregistration is not required, the Administrator shall 
deny the application. Before denying any application, the Administrator 
shall issue an order to show cause pursuant to Section 1309.46 and, if 
requested by the applicant, shall hold a hearing on the application 
pursuant to Sec. 1309.51.
    (b) The Certificate of Registration (DEA Form 511) shall contain the 
name, address, and registration number of the registrant, the activity 
authorized by the registration, the amount of fee paid, and the 
expiration date of the registration. The registrant shall maintain the 
certificate of registration at the registered location in a readily 
retrievable manner and shall permit inspection of the certificate by any 
official, agent or employee of the Administration or of any Federal, 
State, or local agency engaged in enforcement of laws relating to List I 
chemicals or controlled substances.



Sec. 1309.43  Suspension or revocation of registration.

    (a) The Administrator may suspend any registration pursuant to 
section 304(a) of the Act (21 U.S.C. 824(a)) for any period of time he 
determines.
    (b) The Administrator may revoke any registration pursuant to 
section 304(a) of the Act (21 U.S.C. 824(a)).
    (c) Before revoking or suspending any registration, the 
Administrator shall issue an order to show cause pursuant to Section 
1309.46 and, if requested by the registrant, shall hold a hearing 
pursuant to Section 1309.51. Notwithstanding the requirements of this 
Section, however, the Administrator may suspend any registration pending 
a final order pursuant to Sec. 1309.44.
    (d) Upon service of the order of the Administrator suspending or 
revoking registration, the registrant shall immediately deliver his or 
her Certificate of Registration to the nearest office of the 
Administration. Also, upon service of the order of the Administrator 
revoking or suspending registration, the registrant shall, as instructed 
by the Administrator:
    (1) Deliver all List I chemicals in his or her possession that were 
obtained under the authority of a registration or an exemption from 
registration granted by the Administrator by regulation, to the nearest 
office of the Administration or to authorized agents of the 
Administration; or
    (2) Place all such List I chemicals in his or her possession under 
seal as described in section 304(f) of the Act (21 U.S.C. 824(f)).
    (e) In the event that revocation or suspension is limited to a 
particular chemical or chemicals, the registrant shall be given a new 
Certificate of Registration for all substances not affected by such 
revocation or suspension; no fee shall be required for the new 
Certificate of Registration. The registrant shall deliver the old 
Certificate of Registration to the nearest office of the Administration. 
Also, upon service of the order of the Administrator revoking or 
suspending registration with respect to a particular chemical or 
chemicals, the registrant shall, as instructed by the Administrator:
    (1) Deliver to the nearest office of the Administration or to 
authorized agents of the Administration all of the particular chemical 
or chemicals in his or her possession that were obtained under the 
authority of a registration or an exemption from registration granted by 
the Administrator by regulation, which are affected by the revocation or 
suspension; or
    (2) Place all of such chemicals under seal as described in section 
304(f) of the Act (21 U.S.C. 824(f)).

[60 FR 32454, June 22, 1995, as amended at 62 FR 5916, Feb. 10, 1997]



Sec. 1309.44  Suspension of registration pending final order.

    (a) The Administrator may suspend any registration simultaneously 
with or at any time subsequent to the service upon the registrant of an 
order to show cause why such registration should not be revoked or 
suspended, in any case where he finds that there is an imminent danger 
to the public health or safety. If the Administrator

[[Page 137]]

so suspends, he shall serve with the order to show cause pursuant to 
Sec. 1309.46 an order of immediate suspension that shall contain a 
statement of his findings regarding the danger to public health or 
safety.
    (b) Upon service of the order of immediate suspension, the 
registrant shall promptly return his Certificate of Registration to the 
nearest office of the Administration. Also, upon service of the order of 
immediate suspension, the registrant shall, as instructed by the 
Administrator:
    (1) Deliver to the nearest office of the Administration or to 
authorized agents of the Administration all of the particular chemical 
or chemicals in his or her possession that were obtained under the 
authority of a registration or an exemption from registration granted by 
the Administrator by regulation, which are affected by the revocation or 
suspension; or
    (2) Place all of such chemicals under seal as described in section 
304(f) of the Act (21 U.S.C. 824(f)).
    (c) Any suspension shall continue in effect until the conclusion of 
all proceedings upon the revocation or suspension, including any 
judicial review thereof, unless sooner withdrawn by the Administrator or 
dissolved by a court of competent jurisdiction. Any registrant whose 
registration is suspended under this section may request a hearing on 
the revocation or suspension of his registration at a time earlier than 
specified in the order to show cause pursuant to Section 1309.46, which 
request shall be granted by the Administrator, who shall fix a date for 
such hearing as early as reasonably possible.

[60 FR 32454, June 22, 1995, as amended at 62 FR 5916, Feb. 10, 1997]



Sec. 1309.45  Extension of registration pending final order.

    In the event that an applicant for reregistration (who is doing 
business under a registration previously granted and not revoked or 
suspended) has applied for reregistration at least 45 days before the 
date on which the existing registration is due to expire, and the 
Administrator has issued no order on the application on the date on 
which the existing registration is due to expire, the existing 
registration of the applicant shall automatically be extended and 
continue in effect until the date on which the Administrator so issues 
his order. The Administrator may extend any other existing registration 
under the circumstances contemplated in this section even though the 
registrant failed to apply for reregistration at least 45 days before 
expiration of the existing registration, with or without request by the 
registrant, if the Administrator finds that such extension is not 
inconsistent with the public health and safety.



Sec. 1309.46  Order to show cause.

    (a) If, upon examination of the application for registration from 
any applicant and other information gathered by the Administration 
regarding the applicant, the Administrator is unable to make the 
determinations required by the applicable provisions of section 303 of 
the Act (21 U.S.C. 823) to register the applicant, the Administrator 
shall serve upon the applicant an order to show cause why the 
application for registration should not be denied.
    (b) If, upon information gathered by the Administration regarding 
any registrant, the Administrator determines that the registration of 
such registrant is subject to suspension or revocation pursuant to 
section 304 of the Act (21 U.S.C. 824), the Administrator shall serve 
upon the registrant an order to show cause why the registration should 
not be revoked or suspended.
    (c) The order to show cause shall call upon the applicant or 
registrant to appear before the Administrator at a time and place stated 
in the order, which shall not be less than 30 days after the date of 
receipt of the order. The order to show cause shall also contain a 
statement of the legal basis for such hearing and for the denial, 
revocation, or suspension of registration and a summary of the matters 
of fact and law asserted.
    (d) Upon Receipt of an order to show cause, the applicant or 
registrant must, if he desires a hearing, file a request for a hearing 
pursuant to Sec. 1309.54. If a hearing is requested, the Administrator 
shall hold a hearing at the time and place stated in the order, pursuant 
to Sec. 1309.51.

[[Page 138]]

    (e) When authorized by the Administrator, any agent of the 
Administration may serve the order to show cause.

                                Hearings



Sec. 1309.51  Hearings generally.

    (a) In any case where the Administrator shall hold a hearing on any 
registration or application therefore, the procedures for such hearing 
shall be governed generally by the adjudication procedures set forth in 
the Administrative Procedure Act (5 U.S.C. 551-559) and specifically by 
sections 303 and 304 of the Act (21 U.S.C. 823-824), by Sec. Sec. 
1309.52 through 1309.57, and by the procedures for administrative 
hearings under the Act set forth in Sec. Sec. 1316.41 through 1316.67 
of this chapter.
    (b) Any hearing under this part shall be independent of, and not in 
lieu of, criminal prosecutions or other proceedings under the Act or any 
other law of the United States.



Sec. 1309.52  Purpose of hearing.

    If requested by a person entitled to a hearing, the Administrator 
shall hold a hearing for the purpose of receiving factual evidence 
regarding the issues involved in the denial, revocation, or suspension 
of any registration. Extensive argument should not be offered into 
evidence but rather presented in opening or closing statements of 
counsel or in memoranda or proposed findings of fact and conclusions of 
law.



Sec. 1309.53  Request for hearing or appearance; waiver.

    (a) Any person entitled to a hearing pursuant to Sec. Sec. 1309.42 
and 1309.43 and desiring a hearing shall, within 30 days after the date 
of receipt of the order to show cause, file with the Administrator a 
written request for a hearing in the form prescribed in Sec. 1316.47 of 
this chapter.
    (b) Any person entitled to a hearing pursuant to Sec. Sec. 1309.42 
and 1309.43 may, within the period permitted for filing a request for a 
hearing, file with the Administrator a waiver of an opportunity for a 
hearing, together with a written statement regarding his position on the 
matters of fact and law involved in such hearing. Such statement, if 
admissible, shall be made a part of the record and shall be considered 
in light of the lack of opportunity for cross-examination in determining 
the weight to be attached to matters of fact asserted therein.
    (c) If any person entitled to a hearing pursuant to Sec. Sec. 
1309.42 and 1309.43 fails to file a request for a hearing, or if he so 
files and fails to appear at the hearing, he shall be deemed to have 
waived his opportunity for the hearing, unless he shows good cause for 
such failure.
    (d) If any person entitled to a hearing waives or is deemed to waive 
his or her opportunity for the hearing, the Administrator may cancel the 
hearing, if scheduled, and issue his final order pursuant to Sec. 
1309.57 without a hearing.

[60 FR 32454, June 22, 1995. Redesignated at 62 FR 13968, Mar. 24, 1997]



Sec. 1309.54  Burden of proof.

    (a) At any hearing for the denial of a registration, the 
Administration shall have the burden of proving that the requirements 
for such registration pursuant to section 303 of the Act (21 U.S.C. 823) 
are not satisfied.
    (b) At any hearing for the revocation or suspension of a 
registration, the Administration shall have the burden of proving that 
the requirements for such revocation or suspension pursuant to section 
304(a) of the Act (21 U.S.C. 824(a)) are satisfied.

[60 FR 32454, June 22, 1995. Redesignated at 62 FR 13968, Mar. 24, 1997]



Sec. 1309.55  Time and place of hearing.

    The hearing will commence at the place and time designated in the 
order to show cause or notice of hearing published in the Federal 
Register (unless expedited pursuant to Section 1309.44(c)) but 
thereafter it may be moved to a different place and may be continued 
from day to day or recessed to a later day without notice other than 
announcement thereof by the presiding officer at the hearing.

[60 FR 32454, June 22, 1995. Redesignated at 62 FR 13968, Mar. 24, 1997]

[[Page 139]]

         Modification, Transfer and Termination of Registration



Sec. 1309.61  Modification in registration.

    Any registrant may apply to modify his or her registration to 
authorize the handling of additional List I chemicals or to change his 
or her name or address, by submitting a letter of request to the 
Registration Section, Drug Enforcement Administration. See the Table of 
DEA Mailing Addresses in Sec. 1321.01 of this chapter for the current 
mailing address. The letter shall contain the registrant's name, 
address, and registration number as printed on the certificate of 
registration, and the List I chemicals to be added to his registration 
or the new name or address and shall be signed in accordance with Sec. 
1309.32(g). No fee shall be required to be paid for the modification. 
The request for modification shall be handled in the same manner as an 
application for registration. If the modification in registration is 
approved, the Administrator shall issue a new certificate of 
registration (DEA Form 511) to the registrant, who shall maintain it 
with the old certificate of registration until expiration.

[75 FR 10680, Mar. 9, 2010]



Sec. 1309.62  Termination of registration.

    (a) The registration of any person shall terminate, without any 
further action by the Administration, if and when such person dies, 
ceases legal existence, discontinues business or professional practice, 
or surrenders a registration. Any registrant who ceases legal existence 
or discontinues business or professional practice shall promptly notify 
the Special Agent in Charge of the Administration in the area in which 
the person is located of such fact and seek authority and instructions 
to dispose of any List I chemicals obtained under the authority of that 
registration. Any registrant who ceases legal existence or discontinues 
business or professional practice or wishes to surrender a registration 
shall notify the Special Agent in Charge of the Administration in the 
area in which the person is located of such fact and seek authority and 
instructions to dispose of any List I chemicals obtained under the 
authority of that registration.
    (b) The Special Agent in Charge shall authorize and instruct the 
person to dispose of the List I chemical in one of the following 
manners:
    (1) By transfer to person registered under the Act and authorized to 
possess the substances;
    (2) By delivery to an agent of the Administration or to the nearest 
office of the Administration;
    (3) By such other means as the Special Agent in Charge may determine 
to assure that the substance does not become available to unauthorized 
persons.

[60 FR 32454, June 22, 1995, as amended at 62 FR 5916, Feb. 10, 1997; 76 
FR 61564, Oct. 5, 2011; 77 FR 4236, Jan. 27, 2012]



Sec. 1309.63  Transfer of registration.

    No registration or any authority conferred thereby shall be assigned 
or otherwise transferred except upon such conditions as the 
Administrator may specifically designate and then only pursuant to his 
written consent.

                          Security Requirements



Sec. 1309.71  General security requirements.

    (a) All applicants and registrants must provide effective controls 
and procedures to guard against theft and diversion of List I chemicals. 
Chemicals must be stored in containers sealed in such a manner as to 
indicate any attempts at tampering with the container. Where chemicals 
cannot be stored in sealed containers, access to the chemicals should be 
controlled through physical means or through human or electronic 
monitoring.
    (b) In evaluating the effectiveness of security controls and 
procedures, the Administrator shall consider the following factors:
    (1) The type, form, and quantity of List I chemicals handled;
    (2) The location of the premises and the relationship such location 
bears on the security needs;
    (3) The type of building construction comprising the facility and 
the general characteristics of the building or buildings;

[[Page 140]]

    (4) The availability of electronic detection and alarm systems;
    (5) the extent of unsupervised public access to the facility;
    (6) The adequacy of supervision over employees having access to List 
I chemicals;
    (7) The procedures for handling business guests, visitors, 
maintenance personnel, and nonemployee service personnel in areas where 
List I chemicals are processed or stored;
    (8) The adequacy of the registrant's or applicant's systems for 
monitoring the receipt, distribution, and disposition of List I 
chemicals in its operations.
    (c) Any registrant or applicant desiring to determine whether a 
proposed system of security controls and procedures is adequate may 
submit materials and plans regarding the proposed security controls and 
procedures either to the Special Agent in Charge in the region in which 
the security controls and procedures will be used, or to the Regulatory 
Section, Drug Enforcement Administration. See the Table of DEA Mailing 
Addresses in Sec. 1321.01 of this chapter for the current mailing 
address.

[60 FR 32454, June 22, 1995, as amended at 62 FR 13968, Mar. 24, 1997; 
67 FR 14861, Mar. 28, 2002; 71 FR 56023, Sept. 26, 2006; 75 FR 10680, 
Mar. 9, 2010]



Sec. 1309.72  Felony conviction; employer responsibilities.

    (a) The registrant shall exercise caution in the consideration of 
employment of persons who will have access to listed chemicals, who have 
been convicted of a felony offense relating to controlled substances or 
listed chemicals, or who have, at any time, had an application for 
registration with the DEA denied, had a DEA registration revoked, or 
surrendered a DEA registration for cause. (For purposes of this 
subsection, the term ``for cause'' means a surrender in lieu of, or as a 
consequence of, any Federal or State administrative, civil or criminal 
action resulting from an investigation of the individual's handling of 
controlled substances or listed chemicals.) The registrant should be 
aware of the circumstances regarding the action against the potential 
employee and the rehabilitative efforts following the action. The 
registrant shall assess the risks involved in employing such persons, 
including the potential for action against the registrant pursuant to 
Sec. 1309.43, If such person is found to have diverted listed 
chemicals, and, in the event of employment, shall institute procedures 
to limit the potential for diversion of List I chemicals.
    (b) It is the position of DEA that employees who possess, sell, use 
or divert listed chemicals or controlled substances will subject 
themselves not only to State or Federal prosecution for any illicit 
activity, but shall also immediately become the subject of independent 
action regarding their continued employment. The employer will assess 
the seriousness of the employee's violation, the position of 
responsibility held by the employee, past record of employment, etc., in 
determining whether to suspend, transfer, terminate or take other action 
against the employee.



Sec. 1309.73  Employee responsibility to report diversion.

    Reports of listed chemical diversion by fellow employees is not only 
a necessary part of an overall employee security program but also serves 
the public interest at large. It is, therefore, the position of DEA that 
an employee who has knowledge of diversion from his employer by a fellow 
employee has an obligation to report such information to a responsible 
security official of the employer. The employer shall treat such 
information as confidential and shall take all reasonable steps to 
protect the confidentiality of the information and the identity of the 
employee furnishing information. A failure to report information of 
chemical diversion will be considered in determining the feasibility of 
continuing to allow an employee to work in an area with access to 
chemicals. The employer shall inform all employees concerning this 
policy.



PART 1310_RECORDS AND REPORTS OF LISTED CHEMICALS AND CERTAIN 
MACHINES--Table of Contents



Sec.
1310.01 Definitions.

[[Page 141]]

1310.02 Substances covered.
1310.03 Persons required to keep records and file reports.
1310.04 Maintenance of records.
1310.05 Reports.
1310.06 Content of records and reports.
1310.07 Proof of identity.
1310.08 Excluded transactions.
1310.09 Temporary exemption from registration.
1310.10 Removal of the exemption of drugs distributed under the Federal 
          Food, Drug and Cosmetic Act.
1310.11 Reinstatement of exemption for drug products distributed under 
          the Food, Drug and Cosmetic Act.
1310.12 Exempt chemical mixtures.
1310.13 Exemption of chemical mixtures; application.
1310.14 Removal of exemption from definition of regulated transaction.
1310.15 Exempt drug products containing ephedrine and therapeutically 
          significant quantities of another active medicinal ingredient.
1310.21 Sale by Federal departments or agencies of chemicals which could 
          be used to manufacture controlled substances.

    Authority: 21 U.S.C. 802, 827(h), 830, 871(b) 890.

    Source: 54 FR 31665, Aug. 1, 1989, unless otherwise noted.



Sec. 1310.01  Definitions.

    Any term used in this part shall have the definition set forth in 
section 102 of the Act (21 U.S.C. 802) or part 1300 of this chapter.

[62 FR 13968, Mar. 24, 1997]



Sec. 1310.02  Substances covered.

    The following chemicals have been specifically designated by the 
Administrator of the Drug Enforcement Administration as the listed 
chemicals subject to the provisions of this part and parts 1309 and 1313 
of this chapter. Each chemical has been assigned the DEA Chemical Code 
Number set forth opposite it.
    (a) List I chemicals

 
 
 
(1) Anthranilic acid, its esters, and its salts.................    8530
(2) Benzyl cyanide..............................................    8735
(3) Ephedrine, its salts, optical isomers, and salts of optical     8113
 isomers........................................................
(4) Ergonovine and its salts....................................    8675
(5) Ergotamine and its salts....................................    8676
(6) N-Acetylanthranilic acid, its esters, and its salts.........    8522
(7) Norpseudoephedrine, its salts, optical isomers, and salts of    8317
 optical isomers................................................
(8) Phenylacetic acid, its esters, and its salts................    8791
(9) Phenylpropanolamine, its salts, optical isomers, and salts      1225
 of optical isomers.............................................
(10) Piperidine and its salts...................................    2704
(11) Pseudoephedrine, its salts, optical isomers, and salts of      8112
 optical isomers................................................
(12) 3,4-Methylenedioxyphenyl-2-propanone.......................    8502
(13) Methylamine and its salts..................................    8520
(14) Ethylamine and its salts...................................    8678
(15) Propionic anhydride........................................    8328
(16) Isosafrole.................................................    8704
(17) Safrole....................................................    8323
(18) Piperonal..................................................    8750
(19) N-Methylephedrine, its salts, optical isomers, and salts of    8115
 optical isomers (N-Methylephedrine)............................
(20) N-Methylpseudoephedrine, its salts, optical isomers, and       8119
 salts of optical isomers.......................................
(21) Hydriodic Acid.............................................    6695
(22) Benzaldehyde...............................................    8256
(23) Nitroethane................................................    6724
(24) Gamma-Butyrolactone (Other names include: GBL; Dihydro-2       2011
 (3H)-furanone; 1,2-Butanolide; 1,4-Butanolide; 4-
 Hydroxybutanoic acid lactone; gamma-hydroxybutyric acid
 lactone).......................................................
(25) Red phosphorus.............................................    6795
(26) White phosphorus (Other names: Yellow Phosphorus)..........    6796
(27) Hypophosphorous acid and its salts (Including ammonium         6797
 hypophosphite, calcium hypophosphite, iron hypophosphite,
 potassium hypophosphite, manganese hypophosphite, magnesium
 hypophosphite and sodium hypophosphite)........................
(28) N-phenethyl-4-piperidone (NPP).............................    8332
(29) Iodine.....................................................    6699
(30) Ergocristine and its salts.................................    8612
 

    (b) List II chemicals:

 
 
 
(1) Acetic anhydride............................................    8519
(2) Acetone.....................................................    6532

[[Page 142]]

 
(3) Benzyl chloride.............................................    8570
(4) Ethyl ether.................................................    6584
(5) Potassium permanganate......................................    6579
(6) 2-Butanone (or Methyl Ethyl Ketone or MEK)..................    6714
(7) Toluene.....................................................    6594
(8) Hydrochloric acid (including anhydrous hydrogen chloride)...    6545
(9) Sulfuric acid...............................................    6552
(10) Methyl Isobutyl Ketone (MIBK)..............................    6715
(11) Sodium Permanganate........................................    6588
 

    (c) The Administrator may add or delete a substance as a listed 
chemical by publishing a final rule in the Federal Register following a 
proposal which shall be published at least 30 days prior to the final 
rule.
    (d) Any person may petition the Administrator to have any substance 
added or deleted from paragraphs (a) or (b) of this section.
    (e) Any petition under this section shall contain the following 
information:
    (1) The name and address of the petitioner;
    (2) The name of the chemical to which the petition pertains;
    (3) The name and address of the manufacturer(s) of the chemical (if 
known);
    (4) A complete statement of the facts which the petitioner believes 
justifies the addition or deletion of the substance from paragraphs (a) 
or (b) of this section;
    (5) The date of the petition.
    (f) The Administrator may require the petitioner to submit such 
documents or written statements of fact relevant to the petition as he 
deems necessary in making a determination.
    (g) Within a reasonable period of time after the receipt of the 
petition, the Administrator shall notify the petitioner of his decision 
and the reason therefor. The Administrator need not accept a petition if 
any of the requirements prescribed in paragraph (e) of this section or 
requested pursuant to paragraph (f) of this section are lacking or are 
not clearly set forth as to be readily understood. If the petitioner 
desires, he may amend and resubmit the petition to meet the requirements 
of paragraphs (e) and (f) of this section.
    (h) If a petition is granted or the Administrator, upon his own 
motion, proposes to add or delete substances as listed chemicals as set 
forth in paragraph (c) of this section, he shall issue and publish in 
the Federal Register a proposal to add or delete a substance as a listed 
chemical. The Administrator shall permit any interested person to file 
written comments regarding the proposal within 30 days of the date of 
publication of his order in the Federal Register. The Administrator will 
consider any comments filed by interested persons and publish a final 
rule in accordance with his decision in the matter.

[54 FR 31665, Aug. 1, 1989, as amended at 56 FR 48733, Sept. 26, 1991; 
57 FR 43615, Sept. 22, 1992; 60 FR 19510, Apr. 19, 1995; 60 FR 32460, 
June 22, 1995; 62 FR 5917, Feb. 10, 1997; 65 FR 21647, Apr. 24, 2000; 65 
FR 47316, Aug. 2, 2000; 66 FR 52675, Oct. 17, 2001; 71 FR 60826, Oct. 
17, 2006; 72 FR 20046, Apr. 23, 2007; 72 FR 35391, July 2, 2007; 72 FR 
40238, July 24, 2007; 76 FR 17781, Mar. 31, 2011]



Sec. 1310.03  Persons required to keep records and file reports.

    (a) Each regulated person who engages in a regulated transaction 
involving a listed chemical, a tableting machine, or an encapsulating 
machine shall keep a record of the transaction as specified by Sec. 
1310.04 and file reports as specified by Sec. 1310.05. However, a non-
regulated person who acquires listed chemicals for internal consumption 
or ``end use'' and becomes a regulated person by virtue of infrequent or 
rare distribution of a listed chemical from inventory, shall not be 
required to maintain receipt records of listed chemicals under this 
section.
    (b) Each regulated person who manufactures a List I or List II 
chemical shall file reports regarding such manufacture as specified in 
Section 1310.05.
    (c) Each regulated person who engages in a transaction with a 
nonregulated person or who engages in an export transaction that 
involves ephedrine, pseudoephedrine, phenylpropanolamine, or gamma-
hydroxybutyric acid, including drug products containing these chemicals, 
and uses or attempts to use the Postal Service or any private or 
commercial carrier must file monthly reports of each such

[[Page 143]]

transaction as specified in Sec. 1310.05 of this part.

[54 FR 31665, Aug. 1, 1989, as amended at 56 FR 8277, Feb. 28, 1991; 61 
FR 14023, Mar. 29, 1996; 67 FR 14861, Mar. 28, 2002; 68 FR 57804, Oct. 
7, 2003; 70 FR 294, Jan. 4, 2005]



Sec. 1310.04  Maintenance of records.

    (a) Every record required to be kept subject to Sec. 1310.03 for a 
List I chemical, a tableting machine, or an encapsulating machine shall 
be kept by the regulated person for 2 years after the date of the 
transaction.
    (b) Every record required to be kept subject to Section 1310.03 for 
List II chemical shall be kept by the regulated person for two years 
after the date of the transaction.
    (c) A record under this section shall be kept at the regulated 
person's place of business where the transaction occurred, except that 
records may be kept at a single, central location of the regulated 
person if the regulated person has notified the Administration of the 
intention to do so. Written notification must be submitted by registered 
or certified mail, return receipt requested, to the Special Agent in 
Charge of the DEA Divisional Office for the area in which the records 
are required to be kept.
    (d) The records required to be kept under this section shall be 
readily retrievable and available for inspection and copying by 
authorized employees of the Administration under the provisions of 21 
U.S.C. 880.
    (e) The regulated person with more than one place of business where 
records are required to be kept shall devise a system to detect any 
party purchasing from several individual locations of the regulated 
person thereby seeking to avoid the application of the cumulative 
threshold or evading the requirements of the Act.
    (f) For those listed chemicals for which thresholds have been 
established, the quantitative threshold or the cumulative amount for 
multiple transactions within a calendar month, to be utilized in 
determining whether a receipt, sale, importation or exportation is a 
regulated transaction is as follows:
    (1) List I chemicals:
    (i) Except as provided in paragraph (f)(1)(ii) of this section, the 
following thresholds have been established for List I chemicals.

------------------------------------------------------------------------
                                                          Threshold by
             Code                      Chemical            base weight
------------------------------------------------------------------------
8522..........................  N-Acetylanthranilic     40 kilograms.
                                 acid, its esters, and
                                 its salts.
8530..........................  Anthranilic acid, its   30 kilograms.
                                 esters, and its salts.
8256..........................  Benzaldehyde..........  4 kilograms.
8735..........................  Benzyl cyanide........  1 kilogram.
8675..........................  Ergonovine and its      10 grams.
                                 salts.
8676..........................  Ergotamine and its      20 grams.
                                 salts.
8678..........................  Ethylamine and its      1 kilogram.
                                 salts.
6695..........................  Hydriodic acid........  1.7 kilograms
                                                         (or 1 liter by
                                                         volume).
8704..........................  Isosafrole............  4 kilograms.
8520..........................  Methylamine and its     1 kilogram.
                                 salts.
8502..........................  3,4-Methylenedioxyphen  4 kilograms.
                                 yl-2-propanone.
8115..........................  N-Methylephedrine, its  1 kilogram.
                                 salts, optical
                                 isomers, and salts of
                                 optical isomers.
8119..........................  N-Methylpseudoephedrin  1 kilogram.
                                 e, its salts, optical
                                 isomers, and salts of
                                 optical isomers.
6724..........................  Nitroethane...........  2.5 kilograms.
8317..........................  Norpseudoephedrine,     2.5 kilograms.
                                 its salts, optical
                                 isomers, and salts of
                                 optical isomers.
8791..........................  Phenylacetic acid, its  1 kilogram.
                                 esters, and its salts.
2704..........................  Piperidine and its      500 grams.
                                 salts.
8750..........................  Piperonal (also called  4 kilograms.
                                 heliotropine).
8328..........................  Propionic anhydride...  1 gram.
8323..........................  Safrole...............  4 kilograms.
------------------------------------------------------------------------

    (ii) For List I chemicals that are contained in scheduled listed 
chemical products as defined in Sec. 1300.02 of this chapter, the 
thresholds established in paragraph (g) of this section apply only to 
non-retail distribution, import, and export. Sales of these products at 
retail

[[Page 144]]

are subject to the requirements of part 1314 of this chapter.
    (2) List II Chemicals:
    (i) Imports and Exports

----------------------------------------------------------------------------------------------------------------
                Chemical                         Threshold by volume                  Threshold by weight
----------------------------------------------------------------------------------------------------------------
(A) Acetic anhydride...................  250 gallons........................  1,023 kilograms.
(B) Acetone............................  500 gallons........................  1,500 kilograms.
(C) Benzyl chloride....................  N/A................................  4 kilograms.
(D) Ethyl ether........................  500 gallons........................  1,364 kilograms.
(E) Potassium permanganate.............  N/A................................  500 kilograms.
(F) 2-Butanone (MEK)...................  500 gallons........................  1,455 kilograms.
(G) Toluene............................  500 gallons........................  1,591 kilograms.
(H) Sodium permanganate................  N/A................................  500 kilograms
----------------------------------------------------------------------------------------------------------------

    (ii) Domestic Sales

----------------------------------------------------------------------------------------------------------------
                Chemical                         Threshold by volume                  Threshold by weight
----------------------------------------------------------------------------------------------------------------
(A) Acetic anhydride...................  250 gallons........................  1,023 kilograms.
(B) Acetone............................  50 gallons.........................  150 kilograms.
(C) Benzyl chloride....................  N/A................................  1 kilogram.
(D) Ethyl ether........................  50 gallons.........................  135.8 kilograms.
(E) Potassium permanganate.............  N/A................................  55 kilograms.
(F) 2-Butanone (MEK)...................  50 gallons.........................  145 kilograms.
(G) Toluene............................  50 gallons.........................  159 kilograms.
(H) Anhydrous Hydrogen chloride........  N/A................................  0.0 kilograms.
(I) Sodium permanganate................  N/A................................  55 kilograms
----------------------------------------------------------------------------------------------------------------

    (iii) The cumulative threshold is not applicable to domestic sales 
of Acetone, 2-Butanone (MEK), and Toluene.
    (iv) Exports, Transshipments and International Transactions to 
Designated Countries as Set Forth in Sec. 1310.08(b).

------------------------------------------------------------------------
                                    Threshold by
            Chemical                   volume        Threshold by weight
------------------------------------------------------------------------
(A) Hydrochloric acid..........  50 gallons
    (1) Anhydrous Hydrogen       ..................  27 kilograms.
     chloride.
(B) Sulfuric acid..............  50 gallons
------------------------------------------------------------------------

    (v) Export and International Transactions to Designated Countries, 
and Importations for Transshipment or Transfer to Designated Countries

------------------------------------------------------------------------
                                    Threshold by
            Chemical                   volume        Threshold by weight
------------------------------------------------------------------------
(A) Methyl Isobutyl Ketone       500 gallons.......  1523 kilograms.
 (MIBK).
(B) Reserved.
------------------------------------------------------------------------

    (g) For listed chemicals for which no thresholds have been 
established, the size of the transaction is not a factor in determining 
whether the transaction meets the definition of a regulated transaction 
as set forth in Sec. 1300.02 of this chapter. All such transactions, 
regardless of size, are subject to recordkeeping and reporting 
requirements as set forth in this part and notification provisions as 
set forth in part 1313 of this chapter.
    (1) Listed chemicals for which no thresholds have been established:
    (i) Ephedrine, its salts, optical isomers, and salts of optical 
isomers;
    (ii) Ergocristine and its salts
    (iii) Gamma-Butyrolactone (Other names include: GBL; Dihydro-2(3H)-
furanone; 1,2-Butanolide; 1,4-Butanolide; 4-Hydroxybutanoic acid 
lactone; gamma-hydroxybutyric acid lactone)
    (iv) Hypophosphorous acid and its salts (including ammonium 
hypophosphite, calcium hypophosphite, iron hypophosphite, potassium 
hypophosphite, manganese hypophosphite, magnesium hypophosphite, and 
sodium hypophosphite)
    (v) Iodine
    (vi) N-phenethyl-4-piperidone (NPP)
    (vii) Pseudoephedrine, its salts, optical isomers, and salts of 
optical isomers
    (viii) Phenylpropanolamine, its salts, optical isomers, and salts of 
optical isomers
    (ix) Red phosphorus

[[Page 145]]

    (x) White phosphorus (Other names: Yellow Phosphorus)
    (2) [Reserved]
    (h) The thresholds and conditions in paragraphs (f) and (g) of this 
section will apply to transactions involving regulated chemical 
mixtures. For purposes of determining whether the weight or volume of a 
chemical mixture meets or exceeds the applicable quantitative threshold, 
the following rules apply:
    (1) For chemical mixtures containing List I chemicals or List II 
chemicals other than those in paragraph (h)(2) of this section, the 
threshold is determined by the weight of the listed chemical in the 
chemical mixture.
    (2) For the List II chemicals acetone, ethyl ether, 2-butanone, 
toluene, and methyl isobutyl ketone, the threshold is determined by the 
weight of the entire chemical mixture.
    (3) If two or more listed chemicals are present in a chemical 
mixture, and the quantity of any of these chemicals equals or exceeds 
the threshold applicable to that chemical, then the transaction is 
regulated.

[54 FR 31665, Aug. 1, 1989]

    Editorial Note: For Federal Register citations affecting Sec. 
1310.04, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and at www.fdsys.gov.



Sec. 1310.05  Reports.

    (a) Each regulated person shall report to the Special Agent in 
Charge of the DEA Divisional Office for the area in which the regulated 
person making the report is located, as follows:
    (1) Any regulated transaction involving an extraordinary quantity of 
a listed chemical, an uncommon method of payment or delivery, or any 
other circumstance that the regulated person believes may indicate that 
the listed chemical will be used in violation of this part.
    (2) Any proposed regulated transaction with a person whose 
description or other identifying characteristic the Administration has 
previously furnished to the regulated person.
    (3) Any unusual or excessive loss or disappearance of a listed 
chemical under the control of the regulated person. The regulated person 
responsible for reporting a loss in-transit is the supplier.
    (4) Any domestic regulated transaction in a tableting machine or an 
encapsulating machine.
    (b) Each report submitted pursuant to paragraph (a) of this section 
shall, whenever possible, be made orally to the DEA Divisional Office 
for the area in which the regulated person making the report is located 
at the earliest practicable opportunity after the regulated person 
becomes aware of the circumstances involved and as much in advance of 
the conclusion of the transaction as possible. Written reports of 
transactions listed in paragraphs (a)(1), (a)(3) and (a)(4) of this 
section will subsequently be filed as set forth in Sec. 1310.06 within 
15 days after the regulated person becomes aware of the circumstances of 
the event. A transaction may not be completed with a person whose 
description or identifying characteristic has previously been furnished 
to the regulated person by the Administration unless the transaction is 
approved by the Administration.
    (c) Each regulated person who imports or exports a tableting 
machine, or encapsulation machine, shall file a report (not a 486) of 
such importation or exportation with the Import/Export Unit, Drug 
Enforcement Administration, on or before the date of importation or 
exportation. See the Table of DEA Mailing Addresses in Sec. 1321.01 of 
this chapter for the current mailing address. In order to facilitate the 
importation or exportation of any tableting machine or encapsulating 
machine and implement the purpose of the Act, regulated persons may wish 
to report to the Administration as far in advance as possible. A copy of 
the report may be transmitted directly to the Drug Enforcement 
Administration through electronic facsimile media. Any tableting machine 
or encapsulating machine may be imported or exported if that machine is 
needed for medical, commercial, scientific, or other legitimate uses. 
However, an importation or exportation of a tableting machine or 
encapsulating machine may not be completed with a person whose 
description or identifying characteristic has

[[Page 146]]

previously been furnished to the regulated person by the Administration 
unless the transaction is approved by the Administration.
    (d) Each regulated bulk manufacturer of a listed chemical shall 
submit manufacturing, inventory and use data on an annual basis as set 
forth in Sec. 1310.06(h). This data shall be submitted annually to the 
Drug and Chemical Evaluation Section, Drug Enforcement Administration, 
on or before the 15th day of March of the year immediately following the 
calendar year for which submitted. See the Table of DEA Mailing 
Addresses in Sec. 1321.01 of this chapter for the current mailing 
address. A business entity which manufactures a listed chemical may 
elect to report separately by individual location or report as an 
aggregate amount for the entire business entity provided that they 
inform the DEA of which method they will use. This reporting requirement 
does not apply to drug or other products which are exempted under 
paragraphs (1)(iv) or (1)(v) of the definition of regulated transaction 
in Sec. 1300.02 of this chapter except as set forth in Sec. 
1310.06(h)(5). Bulk manufacturers that produce a listed chemical solely 
for internal consumption shall not be required to report for that listed 
chemical. For purposes of these reporting requirements, internal 
consumption shall consist of any quantity of a listed chemical otherwise 
not available for further resale or distribution. Internal consumption 
shall include (but not be limited to) quantities used for quality 
control testing, quantities consumed in-house or production losses. 
Internal consumption does not include the quantities of a listed 
chemical consumed in the production of exempted products. If an existing 
standard industry report contains the information required in Sec. 
1310.06(h) and such information is separate or readily retrievable from 
the report, that report may be submitted in satisfaction of this 
requirement. Each report shall be submitted to the DEA under company 
letterhead and signed by an appropriate, responsible official. For 
purposes of this paragraph only, the term regulated bulk manufacturer of 
a listed chemical means a person who manufactures a listed chemical by 
means of chemical synthesis or by extraction from other substances. The 
term bulk manufacturer does not include persons whose sole activity 
consists of the repackaging or relabeling of listed chemical products or 
the manufacture of drug dosage form products which contain a listed 
chemical.
    (e) Each regulated person required to report pursuant to Sec. 
1310.03(c) of this part shall either:
    (1) Submit a written report, containing the information set forth in 
Sec. 1310.06(i) of this part, on or before the 15th day of each month 
following the month in which the distributions took place. The report 
shall be submitted under company letterhead, signed by the person 
authorized to sign the registration application forms on behalf of the 
registrant, to the Import/Export Unit, Drug Enforcement Administration 
(see the Table of DEA Mailing Addresses in Sec. 1321.01 of this chapter 
for the current mailing address); or
    (2) Upon request to and approval by the Administration, submit the 
report in electronic form, either via computer disk or direct electronic 
data transmission, in such form as the Administration shall direct. 
Requests to submit reports in electronic form should be submitted to the 
Import/Export Unit, Drug Enforcement Administration. See the Table of 
DEA Mailing Addresses in Sec. 1321.01 of this chapter for the current 
mailing address.
    (f) Except as provided in paragraph (g) of this section, the 
following distributions to nonregulated persons, and the following 
export transactions, are not subject to the reporting requirements in 
Sec. 1310.03(c):
    (1) Distributions of sample packages of drug products when those 
packages contain not more than two solid dosage units or the equivalent 
of two dosage units in liquid form, not to exceed 10 milliliters of 
liquid per package, and not more than one package is distributed to an 
individual or residential address in any 30-day period.
    (2) Distributions of drug products by retail distributors that may 
not include face-to-face transactions to the extent that such 
distributions are consistent with the activities authorized for a retail 
distributor as defined in Sec. 1300.02 of this chapter, except that

[[Page 147]]

this paragraph does not apply to sales of scheduled listed chemical 
products at retail.
    (3) Distributions of drug products to a resident of a long term care 
facility or distributions of drug products to a long term care facility 
for dispensing to or for use by a resident of that facility.
    (4) Distributions of drug products in accordance with a valid 
prescription.
    (5) Exports which have been reported to the Administrator under 
Sec. Sec. 1313.31 and 1313.32 of this chapter or which are subject to a 
waiver granted under Sec. 1313.21 of this chapter.
    (g) The Administrator may revoke any or all of the exemptions listed 
in paragraph (f) of this section for an individual regulated person if 
the Administrator finds that drug products distributed by the regulated 
person are being used in violation of the regulations in this chapter or 
the Controlled Substances Act. The Administrator will notify the 
regulated person of the revocation, as provided in Sec. 1313.41(a) of 
this chapter. The revocation will be effective upon receipt of the 
notice by the person. The regulated person has the right to an expedited 
hearing regarding the revocation, as provided in Sec. 1313.56(a) of 
this chapter.

[54 FR 31665, Aug. 1, 1989, as amended at 57 FR 2461, Jan. 22, 1992; 61 
FR 14024, Mar. 29, 1996; 61 FR 17958, Apr. 23, 1996; 62 FR 13968, Mar. 
24, 1997; 67 FR 14862, Mar. 28, 2002; 67 FR 49569, July 31, 2002; 68 FR 
57804, Oct. 7, 2003; 71 FR 56024, Sept. 26, 2006; 75 FR 10680, Mar. 9, 
2010; 77 FR 4236, Jan. 27, 2012]



Sec. 1310.06  Content of records and reports.

    (a) Each record required by Sec. 1310.03 shall include the 
following:
    (1) The name, address, and, if required, DEA registration number of 
each party to the regulated transaction.
    (2) The date of the regulated transaction.
    (3) The name, quantity and form of packaging of the listed chemical 
or a description of the tableting machine or encapsulating machine 
(including make, model and serial number).
    (4) The method of transfer (company truck, picked up by customer, 
etc.).
    (5) The type of identification used by the purchaser and any unique 
number on that identification.
    (b) For purposes of this section, normal business records shall be 
considered adequate if they contain the information listed in paragraph 
(a) of this section and are readily retrievable from other business 
records of the regulated person. For prescription drug products, 
prescription and hospital records kept in the normal course of medical 
treatment shall be considered adequate for satisfying the requirements 
of paragraph (a) of this section with respect to dispensing to patients, 
and records required to be maintained pursuant to the Federal Food and 
Drug Administration regulations relating to the distribution of 
prescription drugs, as set forth in 21 CFR part 205, shall be considered 
adequate for satisfying the requirements of paragraph (a) of this 
section with respect to distributions.
    (c) Each report required by Section 1310.05(a) shall include the 
information as specified by Section 1310.06(a) and, where obtainable, 
the registration number of the other party, if such party is registered. 
A report submitted pursuant to Sec. 1310.05(a)(1) or (a)(4) must also 
include a description of the circumstances leading the regulated person 
to make the report, such as the reason that the method of payment was 
uncommon or the loss unusual. If the report is for a loss or 
disappearance under Sec. 1310.05(a)(4), the circumstances of such loss 
must be provided (in-transit, theft from premises, etc.)
    (d) A suggested format for the reports is provided below:

Supplier:

Registration Number_____________________________________________________
Name____________________________________________________________________
Business Address________________________________________________________
City____________________________________________________________________
State___________________________________________________________________
Zip_____________________________________________________________________
Business Phone__________________________________________________________

Purchaser:

Registration Number_____________________________________________________
Name____________________________________________________________________
Business Address________________________________________________________
City____________________________________________________________________
State___________________________________________________________________
Zip_____________________________________________________________________
Business Phone__________________________________________________________
Identification__________________________________________________________


[[Page 148]]

________________________________________________________________________
Shipping Address (if different than purchaser Address):

Street__________________________________________________________________
City____________________________________________________________________
State___________________________________________________________________
Zip_____________________________________________________________________
Date of Shipment________________________________________________________
Name of Listed Chemical(s)______________________________________________
Quantity and Form of Packaging__________________________________________

Description of Machine:

Make____________________________________________________________________
Model___________________________________________________________________
Serial ________________________________________________________
Method of Transfer______________________________________________________

If Loss or Disappearance:

Date of Loss____________________________________________________________
Type of Loss____________________________________________________________
Description of Circumstances____________________________________________
    (e) Each report of an importation of a tableting machine or an 
encapsulating machine required by Sec. 1310.05(c) shall include the 
following information:
    (1) The name, address, telephone number, and, where available, the 
facsimile number of the regulated person; the name, address, telephone 
number, and, where available, the facsimile number of the import broker 
or forwarding agent, if any:
    (2) The description of each machine (including make, model, and 
serial number) and the number of machines being received;
    (3) The proposed import date, and the first U.S. Customs Port of 
Entry; and
    (4) The name, address, telephone number, and, where available, the 
facsimile number of the consignor in the foreign country of exportation.
    (f) Each report of an exportation of a tableting machine or an 
encapsulating machine required by Sec. 1310.05(c) shall include the 
following information:
    (1) The name, address, telephone number, and, where available, the 
facsimile number of the regulated person; the name, address, telephone 
number, and, where available, the facsimile number of the export broker, 
if any:
    (2) The description of each machine (including make, model, and 
serial number) and the number of machines being shipped;
    (3) The proposed export date, the U.S. Customs Port of exportation, 
and the foreign Port of Entry; and
    (4) The name, address, telephone number, and, where available, the 
facsimile number of the consignee in the country where the shipment is 
destined; the name(s) and address(es) of any intermediate consignee(s).
    (g) Declared exports of machines which are refused, rejected, or 
otherwise deemed undeliverable may be returned to the U.S. exporter of 
record. A brief written report outlining the circumstances must be sent 
to the Import/Export Unit, Drug Enforcement Administration, following 
the return within a reasonable time. See the Table of DEA Mailing 
Addresses in Sec. 1321.01 of this chapter for the current mailing 
address. This provision does not apply to shipments that have cleared 
foreign customs, been delivered, and accepted by the foreign consignee. 
Returns to third parties in the United States will be regarded as 
imports.
    (h) Each annual report required by Section 1310.05(d) shall provide 
the following information for each listed chemical manufactured:
    (1) The name, address and chemical registration number (if any) of 
the manufacturer and person to contact for information.
    (2) The aggregate quantity of each listed chemical that the company 
manufactured during the preceding calendar year.
    (3) The year-end inventory of each listed chemical as of the close 
of business on the 31st day of December of each year. (For each listed 
chemical, if the prior period's ending inventory has not previously been 
reported to DEA, this report should also detail the beginning inventory 
for the period.) For purposes of this requirement, inventory shall 
reflect the quantity of listed chemicals, whether in bulk or non-exempt 
product form, held in storage for later distribution. Inventory does not 
include waste material for destruction, material stored as an in-process 
intermediate or other in-process material.
    (4) The aggregate quantity of each listed chemical used for internal 
consumption during the preceding calendar year, unless the chemical is 
produced solely for internal consumption.
    (5) The aggregate quantity of each listed chemical manufactured 
which becomes a component of a product exempted from paragraphs (1)(iv) 
or (1)(v)

[[Page 149]]

of the definition of regulated transaction in Sec. 1300.02 of this 
chapter during the preceding calendar year.
    (6) Data shall identify the specific isomer, salt or ester when 
applicable but quantitative data shall be reported as anhydrous base or 
acid in kilogram units of measure.
    (i) Each monthly report required by Sec. 1310.05(e) of this part 
shall provide the following information for each distribution:
    (1) Supplier name and registration number.
    (2) Purchaser's name and address.
    (3) Name/address shipped to (if different from purchaser's name/
address).
    (4) Name of the chemical and total amount shipped (i.e., 
Pseudoephedrine, 250 grams).
    (5) Date of shipment.
    (6) Product name (if drug product).
    (7) Dosage form (if drug product) (i.e., pill, tablet, liquid).
    (8) Dosage strength (if drug product) (i.e., 30mg, 60mg, per dose 
etc.).
    (9) Number of dosage units (if drug product) (100 doses per 
package).
    (10) Package type (if drug product) (bottle, blister pack, etc.).
    (11) Number of packages (if drug product) (10 bottles).
    (12) Lot number (if drug product).
    (j) Information provided in reports required by Sec. 1310.05(e) of 
this part which is exempt from disclosure under section 552(a) of Title 
5, by reason of section 552(b)(6) of Title 5, will be provided the same 
protections from disclosure as are provided in section 310(c) of the Act 
(21 U.S.C. 830(c)) for confidential business information.

[54 FR 31665, Aug. 1, 1989, as amended at 57 FR 2462, Jan. 22, 1992; 59 
FR 51364, Oct. 11, 1994; 60 FR 32461, June 22, 1995; 61 FR 14024, Mar. 
29, 1996; 61 FR 32926, June 26, 1996; 67 FR 14862, Mar. 28, 2002; 67 FR 
49569, July 31, 2002; 75 FR 10681, Mar. 9, 2010; 77 FR 4236, Jan. 27, 
2012]



Sec. 1310.07  Proof of identity.

    (a) Each regulated person who engages in a regulated transaction 
must identify the other party to the transaction. For domestic 
transaction, this shall be accomplished by having the other party 
present documents which would verify the identity, or registration 
status if a registrant, of the other party to the regulated person at 
the time the order is placed. For export transactions, this shall be 
accomplished by good faith inquiry through reasonably available research 
documents or publicly available information which would indicate the 
existence of the foreign customer. No proof of identity is required for 
foreign suppliers.
    (b) The regulated person must verify the existence and apparent 
validity of a business entity ordering a listed chemical, tableting 
machine or encapsulating machine. For domestic transactions, this may be 
accomplished by such methods as checking the telephone directory, the 
local credit bureau, the local Chamber of Commerce or the local Better 
Business Bureau, or, if the business entity is a registrant, by 
verification of the registration. For export transactions, a good faith 
inquiry to verify the existence and apparent validity of a foreign 
business entity may be accomplished by such methods as verifying the 
business telephone listing through international telephone information, 
the firm's listing in international or foreign national chemical 
directories or other commerce directories or trade publications, 
confirmation through foreign subsidiaries of the U.S. regulated person, 
verification through the country of destination's embassy Commercial 
Attache, or official documents provided by the purchaser which confirm 
the existence and apparent validity of the business entity.
    (c) When transacting business with a new representative of a firm, 
the regulated person must verify the claimed agency status of the 
representative.
    (d) For sales to individuals or cash purchasers, the type of 
documents and other evidence of proof must consist of at least a 
signature of the purchaser, a driver's license and one other form of 
identification. Any exports to individuals or exports paid in cash are 
suspect and should be handled as such. For such exports, the regulated 
person shall diligently obtain from the purchaser or independently seek 
to confirm clear documentation which proves the person is properly 
identified such as through foreign identity documents, driver's license, 
passport information

[[Page 150]]

and photograph, etc. Any regulated person who fails to adequately prove 
the identity of the other party to the transaction may be subject to the 
specific penalties provided for violations of law related to regulated 
transactions in listed chemicals.
    (e) For a new customer who is not an individual or cash customer, 
the regulated person shall establish the identity of the authorized 
purchasing agent or agents and have on file that person's signature, 
electronic password, or other identification. Once the authorized 
purchasing agent has been established, the agent list may be updated 
annually rather than on each order. The regulated person must ensure 
that shipments are not made unless the order is placed by an authorized 
agent of record.
    (f) With respect to electronic orders, the identity of the purchaser 
shall consist of a computer password, identification number or some 
other means of identification consistent with electronic orders and with 
Sec. 1310.07(e).

[54 FR 31665, Aug. 1, 1989, as amended at 60 FR 32461, June 22, 1995]



Sec. 1310.08  Excluded transactions.

    Pursuant to 21 U.S.C. 802(39)(A)(iii), regulation of the following 
transactions has been determined to be unnecessary for the enforcement 
of the Chemical Diversion and Trafficking Act and, therefore, they have 
been excluded from the definitions of regulated transactions:
    (a) Domestic and import transactions of hydrochloric and sulfuric 
acids but not including anhydrous hydrogen chloride.
    (b) Exports, transshipments, and international transactions of 
hydrochloric (including anhydrous hydrogen chloride) and sulfuric acids, 
except for exports, transshipments and international transactions to the 
following countries:
    (1) Argentina
    (2) Bolivia
    (3) Brazil
    (4) Chile
    (5) Colombia
    (6) Ecuador
    (7) French Guiana
    (8) Guyana
    (9) Panama
    (10) Paraguay
    (11) Peru
    (12) Suriname
    (13) Uruguay
    (14) Venezuela
    (c) Domestic transactions of Methyl Isobutyl Ketone (MIBK).
    (d) Import transactions of Methyl Isobutyl Ketone (MIBK) destined 
for the United States.
    (e) Export transactions, international transactions, and import 
transactions for transshipment or transfer of Methyl Isobutyl Ketone 
(MIBK) destined for Canada or any country outside of the Western 
Hemisphere.
    (f) Domestic and international transactions of Lugol's Solution 
(consisting of 5 percent iodine and 10 percent potassium iodide in an 
aqueous solution) in original manufacturer's packaging of one-fluid-
ounce (30 milliliters) or less, and no greater than one package per 
transaction.
    (g) Import transactions of anhydrous hydrogen chloride.
    (h) Domestic distribution of anhydrous hydrogen chloride weighing 
12,000 pounds (net weight) or more in a single container.
    (i) Domestic distribution of anhydrous hydrogen chloride by 
pipeline.
    (j) Domestic and international return shipments of reusable 
containers from customer to producer containing residual quantities of 
red phosphorus or white phosphorus in rail cars and intermodal tank 
containers which conform to International Standards Organization 
specifications (with capacities greater than or equal to 2,500 gallons 
in a single container).
    (k) Domestic, import, and export distributions of gamma-
butyrolactone weighing 4,000 kilograms (net weight) or more in a single 
container.
    (l) Domestic and import transactions in chemical mixtures that 
contain acetone, ethyl ether, 2-butanone, and/or toluene, unless 
regulated because of being formulated with other List I or

[[Page 151]]

List II chemical(s) above the concentration limit.

[57 FR 43615, Sept. 22, 1992, as amended at 60 FR 19510, Apr. 19, 1995; 
60 FR 32461, June 22, 1995; 62 FR 13968, Mar. 24, 1997; 65 FR 47316, 
Aug. 2, 2000; 66 FR 52675, Oct. 17, 2001; 68 FR 37414, June 24, 2003; 68 
FR 53292, Sept. 10, 2003; 69 FR 74971, Dec. 15, 2004; 72 FR 10928, Mar. 
12, 2007; 72 FR 35931, July 2, 2007]



Sec. 1310.09  Temporary exemption from registration.

    (a) Each person required by section 302 of the act (21 U.S.C. 822) 
to obtain a registration to distribute, import, or export a combination 
ephedrine product is temporarily exempted from the registration 
requirement, provided that the person submits a proper application for 
registration on or before July 12, 1997. The exemption will remain in 
effect for each person who has made such application until the 
Administration has approved or denied that application. This exemption 
applies only to registration; all other chemical control requirements 
set forth in parts 1309, 1310, and 1313 of this chapter remain in full 
force and effect.
    (b) Each person required by section 302 of the Act (21 U.S.C. 822) 
to obtain a registration to distribute, import, or export a drug product 
that contains pseudoephedrine or phenylpropanolamine that is regulated 
pursuant to paragraph (1)(iv) of the definition of regulated transaction 
in Sec. 1300.02 of this chapter is temporarily exempted from the 
registration requirement, provided that the person submits a proper 
application for registration on or before December 3, 1997.The exemption 
will remain in effect for each person who has made such application 
until the Administration has approved or denied that application. This 
exemption applies only to registration; all other chemical control 
requirements set forth in parts 1309, 1310, and 1313 of this chapter 
remain in full force and effect.
    (c) Each person required by section 302 of the act (21 U.S.C. 822) 
to obtain a registration to distribute, import, or export GBL is 
temporarily exempted from the registration requirement, provided that 
the DEA receives a proper application for registration on or before July 
24, 2000. The exemption will remain in effect for each person who has 
made such application until the Administration has approved or denied 
that application. This exemption applies only to registration; all other 
chemical control requirements set forth in parts 1309, 1310, and 1313 of 
this chapter remain in full force and effect.
    (d) Each person required by section 302 of the Act (21 U.S.C. 822) 
to obtain a registration to distribute, import, or export the List I 
chemicals red phosphorus, white phosphorus, and hypophosphorous acid 
(and its salts), is temporarily exempted from the registration 
requirement, provided that the person submits a proper application for 
registration on or before December 17, 2001. The exemption will remain 
in effect for each person who has made such application until the 
Administration has approved or denied that application. This exemption 
applies only to registration; all other chemical control requirements 
set forth in parts 1309, 1310, and 1313 of this chapter remain in full 
force and effect.
    (e) Each person required by section 302 of the Act (21 U.S.C. 822) 
to obtain a registration to distribute, import, or export regulated 
chemical mixtures which contain ephedrine, N-methylephedrine, N-
methylpseudoephedrine, norpseudoephedrine, phenylpropanolamine, and/or 
pseudoephedrine, pursuant to Sec. Sec. 1310.12 and 1310.13, is 
temporarily exempted from the registration requirement, provided that 
DEA receives a proper application for registration or application for 
exemption on or before June 30, 2003. The exemption will remain in 
effect for each person who has made such application until the 
Administration has approved or denied that application. This exemption 
applies only to registration; all other chemical control requirements 
set forth in parts 1309, 1310, and 1313 of this chapter remain in full 
force and effect. Any person who distributes, imports or exports a 
chemical mixture whose application for exemption is subsequently denied 
by DEA must obtain a registration with DEA. A temporary exemption from 
the registration requirement will also be provided for these persons, 
provided that DEA receives a properly completed application for 
registration on or before 30 days following the date

[[Page 152]]

of official DEA notification that the application for exemption has not 
been approved. The temporary exemption for such persons will remain in 
effect until DEA takes final action on their registration application.
    (f) Except for chemical mixtures containing the listed chemicals in 
paragraph (e) of this section, each person required by section 302 of 
the Act (21 U.S.C. 822) to obtain a registration to distribute, import, 
or export regulated chemical mixtures, pursuant to Sec. Sec. 1310.12 
and 1310.13, is temporarily exempted from the registration requirement, 
provided that DEA receives a proper application for registration or 
application for exemption on or before February 14, 2005. The exemption 
will remain in effect for each person who has made such application 
until the Administration has approved or denied that application. This 
exemption applies only to registration; all other chemical control 
requirements set forth in parts 1309, 1310, and 1313 of this chapter 
remain in full force and effect.
    (g) Any person who distributes, imports, or exports a chemical 
mixture whose application for exemption is subsequently denied by DEA 
must obtain a registration with DEA. A temporary exemption from the 
registration requirement will also be provided for these persons, 
provided that DEA receives a properly completed application for 
registration on or before 30 days following the date of official DEA 
notification that the application for exemption has not been approved. 
The temporary exemption for such persons will remain in effect until DEA 
takes final action on their registration application.
    (h) Each person required under 21 U.S.C. 822 and 21 U.S.C. 957 to 
obtain a registration to manufacture, distribute, import, or export 
regulated N-phenethyl-4-piperidone (NPP), including regulated chemical 
mixtures pursuant to Sec. 1310.12, is temporarily exempted from the 
registration requirement, provided that DEA receives a proper 
application for registration or application for exemption for a chemical 
mixture containing NPP pursuant to Sec. 1310.13 on or before June 22, 
2007. The exemption will remain in effect for each person who has made 
such application until the Administration has approved or denied that 
application. This exemption applies only to registration; all other 
chemical control requirements set forth in the Act and parts 1309, 1310, 
1313, and 1316 of this chapter remain in full force and effect. Any 
person who manufactures, distributes, imports or exports a chemical 
mixture containing N-phenethyl-4-piperidone (NPP) whose application for 
exemption is subsequently denied by DEA must obtain a registration with 
DEA. A temporary exemption from the registration requirement will also 
be provided for those persons whose application for exemption are 
denied, provided that DEA receives a properly completed application for 
registration on or before 30 days following the date of official DEA 
notification that the application for exemption has been denied. The 
temporary exemption for such persons will remain in effect until DEA 
takes final action on their registration application.
    (i) Each person required by section 302 of the Act (21 U.S.C. 822) 
to obtain a registration to manufacture, distribute, import, or export 
regulated iodine, including regulated iodine chemical mixtures pursuant 
to Sec. Sec. 1310.12 and 1310.13, is temporarily exempted from the 
registration requirement, provided that the Administration receives a 
proper application for registration or application for exemption for a 
chemical mixture containing iodine on or before August 31, 2007. The 
exemption will remain in effect for each person who has made such 
application until the Administration has approved or denied that 
application. This exemption applies only to registration; all other 
chemical control requirements set forth in the Act and parts 1309, 1310, 
and 1313 of this chapter remain in full force and effect. Any person who 
distributes, imports, or exports a chemical mixture containing iodine 
whose application for exemption is subsequently denied by the 
Administration must obtain a registration with the Administration. A 
temporary exemption from the registration requirement will also be 
provided for these persons, provided that the Administration receives a 
properly completed application for registration on or before 30

[[Page 153]]

days following the date of official Administration notification that the 
application for exemption has not been approved. The temporary exemption 
for such persons will remain in effect until the Administration takes 
final action on their registration application.
    (j) Each person required by section 302 of the Act (21 U.S.C. 822) 
to obtain a registration to manufacture, distribute, import, or export 
regulated chemical mixtures which contain ephedrine, and/or 
pseudoephedrine, pursuant to Sections 1310.12 and 1310.13, is 
temporarily exempted from the registration requirement, provided that 
DEA receives a properly completed application for registration or 
application for exemption on or before August 24, 2007. The exemption 
will remain in effect for each person who has made such application 
until the Administration has approved or denied that application. This 
exemption applies only to registration; all other chemical control 
requirements set forth in parts 1309, 1310, 1313, and 1315 of this 
chapter remain in full force and effect. Any person who manufactures, 
distributes, imports, or exports a chemical mixture whose application 
for exemption is subsequently denied by DEA must obtain a registration 
with DEA. A temporary exemption from the registration requirement will 
also be provided for these persons, provided that DEA receives a 
properly completed application for registration on or before 30 days 
following the date of official DEA notification that the application for 
exemption has not been approved. The temporary exemption for such 
persons will remain in effect until DEA takes final action on their 
registration application.
    (k)(1) Each person required by sections 302 or 1007 of the Act (21 
U.S.C. 822, 957) to obtain a registration to manufacture, distribute, 
import, or export regulated GBL-containing chemical mixtures, pursuant 
to sections 1310.12 and 1310.13, is temporarily exempted from the 
registration requirement, provided that DEA receives a properly 
completed application for registration or application for exemption on 
or before July 29, 2010. The exemption will remain in effect for each 
person who has made such application until the Administration has 
approved or denied that application. This exemption applies only to 
registration; all other chemical control requirements set forth in parts 
1309, 1310, and 1313 of this chapter remain in full force and effect.
    (2) Any person who manufactures, distributes, imports or exports a 
GBL-containing chemical mixture whose application for exemption is 
subsequently denied by DEA must obtain a registration with DEA. A 
temporary exemption from the registration requirement will also be 
provided for those persons whose applications for exemption are denied, 
provided that DEA receives a properly completed application for 
registration on or before 30 days following the date of official DEA 
notification that the application for exemption has been denied. The 
temporary exemption for such persons will remain in effect until DEA 
takes final action on their registration application.
    (l)(1) Each person required under sections 302 and 1007 of the Act 
(21 U.S.C. 822, 957) to obtain a registration to manufacture, 
distribute, import, or export regulated ergocristine and its salts, 
including regulated chemical mixtures pursuant to Sec. 1310.12, is 
temporarily exempted from the registration requirement, provided that 
DEA receives a properly completed application for registration or 
application for exemption for a chemical mixture containing ergocristine 
and its salts pursuant to Sec. 1310.13 on or before May 2, 2011. The 
exemption will remain in effect for each person who has made such 
application until the Administration has approved or denied that 
application. This exemption applies only to registration; all other 
chemical control requirements set forth in the Act and parts 1309, 1310, 
1313, and 1316 of this chapter remain in full force and effect.
    (2) Any person who manufactures, distributes, imports, or exports a 
chemical mixture containing ergocristine and its salts whose application 
for exemption is subsequently denied by DEA must obtain a registration 
with DEA. A temporary exemption from the registration requirement will 
also be provided for those persons whose applications for exemption are

[[Page 154]]

denied, provided that DEA receives a properly completed application for 
registration on or before 30 days following the date of official DEA 
notification that the application for exemption has been denied. The 
temporary exemption for such persons will remain in effect until DEA 
takes final action on their registration application.
    (m)(1) Each person required by Sections 302 or 1007 of the Act (21 
U.S.C. 822, 957) to obtain a registration to manufacture, distribute, 
import, or export regulated chemical mixtures which contain red 
phosphorus, white phosphorus, hypophosphorous acid (and its salts), 
pursuant to Sec. Sec. 1310.12 and 1310.13, is temporarily exempted from 
the registration requirement, provided that DEA receives a properly 
completed application for registration or application for exemption on 
or before July 5, 2011. The exemption will remain in effect for each 
person who has made such application until the Administration has 
approved or denied that application. This exemption applies only to 
registration; all other chemical control requirements set forth in parts 
1309, 1310, and 1313 of this chapter remain in full force and effect.
    (2) Any person who manufactures, distributes, imports, or exports a 
chemical mixture which contains red phosphorus, white phosphorus, 
hypophosphorous acid (and its salts) whose application for exemption is 
subsequently denied by DEA must obtain a registration with DEA. A 
temporary exemption from the registration requirement will also be 
provided for those persons whose applications are denied, provided that 
DEA receives a properly completed application for registration on or 
before 30 days following the date of official DEA notification that the 
application for exemption has not been approved. The temporary exemption 
for such persons will remain in effect until DEA takes final action on 
their registration application.

[62 FR 27693, May 21, 1997, as amended at 62 FR 53960, Oct. 17, 1997; 65 
FR 21647, Apr. 24, 2000; 66 FR 52675, Oct. 17, 2001; 68 FR 23203, May 1, 
2003; 69 FR 74971, Dec. 15, 2004; 72 FR 20046, Apr. 23, 2007; 72 FR 
35931, July 2, 2007; 72 FR 40239, July 24, 2007; 72 FR 40744, July 25, 
2007; 75 FR 37306, June 29, 2010; 76 FR 17781, Mar. 31, 2011; 76 FR 
31829, June 2, 2011; 77 FR 4237, Jan. 27, 2012]



Sec. 1310.10  Removal of the exemption of drugs distributed under the 
Federal Food, Drug and Cosmetic Act.

    (a) The Administrator may remove from exemption under paragraph 
(1)(iv) of the definition of regulated transaction in Sec. 1300.02 of 
this chapter any drug or group of drugs that the Administrator finds is 
being diverted to obtain a listed chemical for use in the illicit 
production of a controlled substance. In removing a drug or group of 
drugs from the exemption the Administrator shall consider:
    (1) The scope, duration, and significance of the diversion;
    (2) Whether the drug or group of drugs is formulated in such a way 
that it cannot be easily used in the illicit production of a controlled 
substance; and
    (3) Whether the listed chemical can be readily recovered from the 
drug or group of drugs.
    (b) Upon determining that a drug or group of drugs should be removed 
from the exemption under paragraph (a) of this section, the 
Administrator shall issue and publish in the Federal Register his 
proposal to remove the drug or group of drugs from the exemption, which 
shall include a reference to the legal authority under which the 
proposal is based. The Administrator shall permit any interested person 
to file written comments on or objections to the proposal. After 
considering any comments or objections filed, the Administrator shall 
publish in the Federal Register his final order.
    (c) The Administrator shall limit the removal of a drug or group of 
drugs from exemption under paragraph (a) of this section to the most 
identifiable type of the drug or group of drugs for which evidence of 
diversion exists unless there is evidence, based on the pattern of 
diversion and other relevant factors, that the diversion will not be 
limited to that particular drug or group of drugs.
    (d) Any manufacturer seeking reinstatement of a particular drug 
product that has been removed from an exemption may apply to the 
Administrator for reinstatement of the exemption for that particular 
drug product on the grounds that the particular drug product is 
manufactured and distributed in

[[Page 155]]

a manner that prevents diversion. In determining whether the exemption 
should be reinstated the Administrator shall consider:
    (1) The package sizes and manner of packaging of the drug product;
    (2) The manner of distribution and advertising of the drug product;
    (3) Evidence of diversion of the drug product;
    (4) Any actions taken by the manufacturer to prevent diversion of 
the drug product; and
    (5) Such other factors as are relevant to and consistent with the 
public health and safety, including the factors described in paragraph 
(a) of this section as applied to the drug product.
    (e) Within a reasonable period of time after receipt of the 
application for reinstatement of the exemption, the Administrator shall 
notify the applicant of his acceptance or non-acceptance of his 
application, and if not accepted, the reason therefor. If the 
application is accepted for filing, the Administrator shall issue and 
publish in the Federal Register his order on the reinstatement of the 
exemption for the particular drug product, which shall include a 
reference to the legal authority under which the order is based. This 
order shall specify the date on which it shall take effect. The 
Administrator shall permit any interested person to file written 
comments on or objections to the order. If any such comments raise 
significant issues regarding any finding of fact or conclusion of law 
upon which the order is based, the Administrator shall immediately 
suspend the effectiveness of the order until he may reconsider the 
application in light of the comments and objections filed. Thereafter, 
the Administrator shall reinstate, revoke, or amend his original order 
as he determines appropriate.
    (f) Unless the Administrator has evidence that the drug product is 
being diverted, as determined by applying the factors set forth in 
paragraph (a) of this section, and the Administrator so notifies the 
applicant, transactions involving a specific drug product will not be 
considered regulated transactions during the following periods:
    (1) While a bonafide application for reinstatement of exemption 
under paragraph (d) of this section for the specific drug product is 
pending resolution, provided that the application for reinstatement is 
filed not later than 60 days after the publication of the final order 
removing the exemption; and
    (2) For a period of 60 days following the Administrator's denial of 
an application for reinstatement.
    (g) An order published by the Administrator in the Federal Register, 
pursuant to paragraph (e) of this section, to reinstate an exemption may 
be modified or revoked with respect to a particular drug product upon a 
finding that:
    (1) Applying the factors set forth in paragraph (a) of this section 
to the particular drug product, the drug product is being diverted; or
    (2) There is a significant change in the data that led to the 
issuance of the final rule.

[60 FR 32461, June 22, 1995, as amended at 62 FR 13968, Mar. 24, 1997; 
67 FR 14862, Mar. 28, 2002; 75 FR 38922, July 7, 2010; 77 FR 4237, Jan. 
27, 2012]



Sec. 1310.11  Reinstatement of exemption for drug products distributed
under the Food, Drug and Cosmetic Act.

    (a) The Administrator has reinstated the exemption for the drug 
products listed in paragraph (e) of this section from application of 
sections 302, 303, 310, 1007, and 1008 of the Act (21 U.S.C. 822-823, 
830, and 957-958), to the extent described in paragraphs (b), (c), and 
(d) of this section.
    (b) No reinstated exemption granted pursuant to 1310.10 affects the 
criminal liability for illegal possession or distribution of listed 
chemicals contained in the exempt drug product.
    (c) Changes in exempt drug product compositions: Any change in the 
quantitative or qualitative composition, trade name or other designation 
of an exempt drug product listed in paragraph (d) requires a new 
application for reinstatement of the exemption.
    (d) The following drug products, in the form and quantity listed in 
the application submitted (indicated as the ``date'') are designated as 
reinstated exempt drug products for the purposes set forth in this 
section:

[[Page 156]]



                                              Exempt Drug Products
----------------------------------------------------------------------------------------------------------------
               Supplier                      Product name                 Form                     Date
----------------------------------------------------------------------------------------------------------------
[Reserved]...........................  .......................  .......................  .......................
----------------------------------------------------------------------------------------------------------------


[60 FR 32462, June 22, 1995]



Sec. 1310.12  Exempt chemical mixtures.

    (a) The chemical mixtures meeting the criteria in paragraphs (c) or 
(d) of this section are exempted by the Administrator from application 
of sections 302, 303, 310, 1007, 1008, and 1018 of the Act (21 U.S.C. 
822, 823, 830, 957, 958, and 971) to the extent described in paragraphs 
(b) and (c) of this section.
    (b) No exemption granted pursuant to this Sec. 1310.12 or Sec. 
1310.13 affects the criminal liability for illegal possession, 
distribution, exportation, or importation of listed chemicals contained 
in the exempt chemical mixture or the civil liability for unlawful acts 
related to exempt chemical mixtures, including distribution in violation 
of 21 U.S.C. 842(a)(11).
    (c) Mixtures containing a listed chemical in concentrations equal to 
or less than those specified in the ``Table of Concentration Limits'' 
are designated as exempt chemical mixtures for the purpose set forth in 
this section. The concentration is determined for liquid-liquid mixtures 
by using the volume or weight and for mixtures containing solids or 
gases by using the unit of weight.

                                          Table of Concentration Limits
----------------------------------------------------------------------------------------------------------------
                                             DEA
                                           chemical          Concentration              Special conditions
                                         code number
----------------------------------------------------------------------------------------------------------------
                                                List I Chemicals
----------------------------------------------------------------------------------------------------------------
N-Acetylanthranilic acid, its salts and         8522  20% by Weight.............  Concentration based on any
 esters.                                                                           combination of N-
                                                                                   acetylanthranilic acid and
                                                                                   its salts and esters.
Anthranilic acid, and its salts and             8530  50% by Weight.............  Concentration is based on any
 esters.                                                                           combination of anthranilic
                                                                                   acid and its salts and
                                                                                   esters.
Benzaldehyde...........................         8256  50% by Weight or Volume...
Benzyl cyanide.........................         8570  20% by Weight or Volume ..
Ephedrine, its salts, optical isomers,          8113  Not exempt at any           Chemical mixtures containing
 and salts of optical isomers.                         concentration.              any amount of ephedrine and/
                                                                                   or pseudoephedrine, and their
                                                                                   salts, optical isomers and
                                                                                   salts of optical isomers are
                                                                                   not exempt due to
                                                                                   concentration, unless
                                                                                   otherwise exempted.
Ergocristine and its salts.............         8612  Not exempt at any           Chemical mixtures containing
                                                       concentration.              any amount of ergocristine
                                                                                   and its salts are not exempt.
Ergonovine and its salts...............         8675  Not exempt at any           Chemical mixtures containing
                                                       concentration.              any amount of ergonovine,
                                                                                   including its salts, are not
                                                                                   exempt.
Ergotamine and its salts...............         8676  Not exempt at any           Chemical mixtures containing
                                                       concentration.              amount of any ergotamine,
                                                                                   including its salts, are not
                                                                                   exempt.
Ethylamine and its salts...............         8678  20% by Weight or Volume...  Ethylamine or its salts in an
                                                                                   inert carrier solvent is not
                                                                                   considered a mixture.
                                                                                   Concentration is based on
                                                                                   ethylamine in the mixture and
                                                                                   not the combination of
                                                                                   ethylamine and carrier
                                                                                   solvent, if any.
Gamma-Butyrolactone....................         2011  70% by weight or volume.
Hydriodic acid.........................         6695  20% by Weight or Volume...
Hypophosphorous acid and its salts.....         6797  30% by weight if a solid,   The weight is determined by
                                                       weight or volume if a       measuring the mass of
                                                       liquid.                     hypophosphorous acid and its
                                                                                   salts in the mixture, the
                                                                                   concentration limit is
                                                                                   calculated by summing the
                                                                                   concentrations of all forms
                                                                                   of hypophosphorous acid and
                                                                                   its salts in the mixture. The
                                                                                   Administration does not
                                                                                   consider a chemical mixture
                                                                                   to mean the combination of a
                                                                                   listed chemical and an inert
                                                                                   carrier. Therefore, any
                                                                                   solution consisting of
                                                                                   hypophosphorous acid (and its
                                                                                   salts), dispersed in water,
                                                                                   alcohol, or another inert
                                                                                   carrier, is not considered a
                                                                                   chemical mixture and is
                                                                                   therefore subject to chemical
                                                                                   regulatory controls at all
                                                                                   concentrations.
Iodine.................................         6699  2.2.......................  Calculated as weight/volume (w/
                                                                                   v).
Isosafrole.............................         8704  20% by Weight or Volume...  Concentration in a mixture
                                                                                   cannot exceed 20% if taken
                                                                                   alone or in any combination
                                                                                   with safrole.
Methylamine and its salts..............         8520  20% by Weight.............  Methylamine or its salts in an
                                                                                   inert carrier solvent is not
                                                                                   considered a mixture. Weight
                                                                                   is based on methylamine in
                                                                                   the mixture and not the
                                                                                   combined weight of carrier
                                                                                   solvent, if any.
3,4-Methylenedioxyphenyl-2-propanone...         8502  20% by Weight.............

[[Page 157]]

 
N-Methylephedrine, its salts, optical           8115  0.1% by Weight............  Concentration based on any
 isomers, and salts of optical isomers.                                            combination of salts N-
                                                                                   methylephedrine, N-
                                                                                   methylpseudoephedrine and
                                                                                   their salts, optical isomers
                                                                                   and salts of optical isomers.
N-Methylpseudoephedrine, its salts,             8119  0.1% by Weight............  Concentration based on any
 optical isomers, and salts of optical                                             combination of N-
 isomers.                                                                          methylpseudoephedrine, N-
                                                                                   methylephedrine, and their
                                                                                   salts, optical isomers and
                                                                                   salts of optical isomers.
Nitroethane............................         6724  20% by Weight or Volume...
Norpseudoephedrine, its salts, optical          8317  0.6% by Weight............  Concentration based on any
 isomers, and salts of optical isomers.                                            combination of
                                                                                   norpseudoephedrine,
                                                                                   phenylpropanolamine and their
                                                                                   salts, optical isomers and
                                                                                   salts of optical isomers.
N-phenethyl-4-piperidone (NPP).........         8332  Not exempt at any           Chemical mixtures containing
                                                       concentration.              any amount of NPP are not
                                                                                   exempt.
Phenylacetic acid, and its salts and            8791  40% by Weight.............  Concentration is based on any
 esters.                                                                           combination of phenylacetic
                                                                                   acid and its salts and
                                                                                   esters.
 
Phenylpropanolamine, its salts, optical         1225  0.6% by Weight............  Concentration based on any
 isomers, and salts of optical isomers.                                            combination of
                                                                                   phenylpropanolamine,
                                                                                   norpseudoephedrine and their
                                                                                   salts, optical isomers and
                                                                                   salts of optical isomers.
Piperidine, and its salts..............         2704  20% by Weight or Volume...  Concentration based on any
                                                                                   combination of piperidine and
                                                                                   its salts. Concentration
                                                                                   based on weight if a solid,
                                                                                   weight or volume if a liquid.
Piperonal..............................         8750  20% by Weight or Volume...
Propionic anhydride....................         8328  20% by Weight or Volume...
Pseudoephedrine, its salts, optical             8112  Not exempt at any           Chemical mixtures containing
 isomers, and salts of optical isomers.                concentration.              any amount of ephedrine and/
                                                                                   or pseudoephedrine, and their
                                                                                   salts, optical isomers and
                                                                                   salts of optical isomers are
                                                                                   not exempt due to
                                                                                   concentration, unless
                                                                                   otherwise exempted.
Red Phosphorus.........................         6795  80% by weight.
Safrole................................         8323  20% by Volume.............  Concentration in a mixture
                                                                                   cannot exceed 20% if taken
                                                                                   alone or in any combination
                                                                                   with isosafrole.
White phosphorus.......................         6796  Not exempt at any           Chemical mixtures containing
                                                       concentration.              any amount of white
                                                                                   phosphorus are not exempt due
                                                                                   to concentration, unless
                                                                                   otherwise exempted.
                                                List II Chemicals
----------------------------------------------------------------------------------------------------------------
Acetic Anhydride.......................         8519  20% by Weight or Volume...
Acetone................................         6532  35% by Weight or Volume...  Exports only; Limit applies to
                                                                                   acetone or any combination of
                                                                                   acetone, ethyl ether, 2-
                                                                                   butanone, methyl isobutyl
                                                                                   ketone, and toluene if
                                                                                   present in the mixture by
                                                                                   summing the concentrations
                                                                                   for each chemical.
Benzyl chloride........................         8568  20% by Weight or Volume...
2-butanone.............................         6714  35% by Weight or Volume...  Exports only; Limit applies to
                                                                                   2-butanone or any combination
                                                                                   of acetone, ethyl ether, 2-
                                                                                   butanone, methyl isobutyl
                                                                                   ketone, and toluene if
                                                                                   present in the mixture by
                                                                                   summing the concentrations
                                                                                   for each chemical.
Ethyl ether............................         6584  35% by Weight or Volume...  Exports only; Limit applies to
                                                                                   ethyl ether or any
                                                                                   combination of acetone, ethyl
                                                                                   ether, 2-butanone, methyl
                                                                                   isobutyl ketone, and toluene
                                                                                   if present in the mixture by
                                                                                   summing the concentrations
                                                                                   for each chemical.
Hydrochloric acid......................         6545  20% by Weight or Volume...  Hydrogen chloride in an inert
                                                                                   carrier solvent, such as
                                                                                   aqueous or alcoholic
                                                                                   solutions, is not considered
                                                                                   a mixture. Weight is based on
                                                                                   hydrogen chloride in the
                                                                                   mixture and not the combined
                                                                                   weight of the carrier
                                                                                   solvent, if any.
Methyl isobutyl ketone.................         6715  35% by Weight or Volume...  Exports only pursuant to Sec.
                                                                                    1310.08; Limit applies to
                                                                                   methyl isobutyl ketone or any
                                                                                   combination of acetone, ethyl
                                                                                   ether, 2-butanone, methyl
                                                                                   isobutyl ketone, and toluene
                                                                                   if present in the mixture by
                                                                                   summing the concentrations
                                                                                   for each chemical.
Potassium permanganate.................         6579  15% by Weight.............
Sodium Permanganate....................         6588  15% by Weight.............

[[Page 158]]

 
Sulfuric acid..........................         6552  20% by Weight or Volume...  Sulfuric acid in an inert
                                                                                   carrier solvent, such as
                                                                                   aqueous or alcoholic
                                                                                   solutions, is not considered
                                                                                   a mixture. Weight is based on
                                                                                   sulfuric acid in the mixture
                                                                                   and not the combined weight
                                                                                   of the carrier solvent, if
                                                                                   any.
Toluene................................          594  35% by Weight or Volume...  Exports only; Limit applies to
                                                                                   toluene or any combination of
                                                                                   acetone, ethyl ether, 2-
                                                                                   butanone, methyl isobutyl
                                                                                   ketone, and toluene if
                                                                                   present in the mixture by
                                                                                   summing the concentrations
                                                                                   for each chemical.
----------------------------------------------------------------------------------------------------------------

    (d) The following categories of chemical mixtures are automatically 
exempt from the provisions of the Controlled Substances Act as described 
in paragraph (a) of this section:
    (1) Chemical mixtures that are distributed directly to an 
incinerator for destruction or directly to an authorized waste recycler 
or reprocessor where such distributions are documented on United States 
Environmental Protection Agency Form 8700-22; persons distributing the 
mixture to the incinerator or recycler must maintain and make available 
to agents of the Administration, upon request, such documentation for a 
period of no less than two years.
    (2) Completely formulated paints and coatings: Completely formulated 
paints and coatings are only those formulations that contain all of the 
components of the paint or coating for use in the final application 
without the need to add any additional substances except a thinner if 
needed in certain cases. A completely formulated paint or coating is 
defined as any clear or pigmented liquid, liquefiable or mastic 
composition designed for application to a substrate in a thin layer that 
is converted to a clear or opaque solid protective, decorative, or 
functional adherent film after application. Included in this category 
are clear coats, top-coats, primers, varnishes, sealers, adhesives, 
lacquers, stains, shellacs, inks, temporary protective coatings and 
film-forming agents.
    (3) Iodine products classified as iodophors that exist as an iodine 
complex to include poloxamer-iodine complex, polyvinyl pyrrolidone-
iodine complex (i.e., povidone-iodine), undecoylium chloride iodine, 
nonylphenoxypoly (ethyleneoxy) ethanol-iodine complex, iodine complex 
with phosphate ester of alkylaryloxy polyethylene glycol, and iodine 
complex with ammonium ether sulfate/polyoxyethylene sorbitan 
monolaurate.
    (4) Iodine products that consist of organically bound iodine (a non-
ionic complex) (e.g., iopamidol, iohexol, and amiodarone.)
    (e) The Administrator may, at any time, terminate or modify the 
exemption for any chemical mixture which has been granted an exemption 
pursuant to the concentration limits as specified in paragraph (c) of 
this section or pursuant to the category exemption as specified in 
paragraph (d) of this section. In terminating or modifying an exemption, 
the Administrator shall issue, and publish in the Federal Register, 
notification of the removal of an exemption for a product or group of 
products for which evidence of diversion has been found, as well as the 
date on which the termination of exemption shall take effect. The 
Administrator shall permit any interested party to file written comments 
on or objections to the order within 60 days of the date of publication 
of the order in the Federal Register. If any such comments or objections 
raise significant issues regarding any finding of fact or conclusion of 
law upon which the order is based, the Administrator shall immediately 
suspend the effectiveness of the order until he may reconsider the order 
in light of comments and objections filed. Thereafter, the Administrator 
shall reinstate, terminate, or amend the original order as determined 
appropriate.
    (f) The Administrator may modify any part of the criteria for 
exemption

[[Page 159]]

as specified in paragraphs (c) and (d) of this section upon evidence of 
diversion or attempted diversion. In doing so, the Administrator shall 
issue and publish a Notice of Proposed Rulemaking in the Federal 
Register. The Administrator shall permit any interested persons to file 
written comments on or objections to the proposal. After considering any 
comments or objections filed, the Administrator shall publish in the 
Federal Register a final order.

[68 FR 23204, May 1, 2003, as amended at 69 FR 74971, Dec. 15, 2004; 71 
FR 60826, Oct. 17, 2006; 72 FR 20047, Apr. 23, 2007; 72 FR 35931, July 
2, 2007; 72 FR 40745, July 25, 2007; 75 FR 37306, June 29, 2010; 76 FR 
17781, Mar. 31, 2011; 76 FR 31830, June 2, 2011]



Sec. 1310.13  Exemption of chemical mixtures; application.

    (a) The Administrator may, by publication of a Final Rule in the 
Federal Register, exempt from the application of all or any part of the 
Act a chemical mixture consisting of two or more chemical components, at 
least one of which is not a List I or List II chemical, if:
    (1) The mixture is formulated in such a way that it cannot be easily 
used in the illicit production of a controlled substance; and
    (2) The listed chemical or chemicals contained in the chemical 
mixture cannot be readily recovered.
    (b) Any manufacturer seeking an exemption for a chemical mixture, 
not exempt under Sec. 1310.12, from the application of all or any part 
of the Act, may apply to the Office of Diversion Control, Drug 
Enforcement Administration. See the Table of DEA Mailing Addresses in 
Sec. 1321.01 of this chapter for the current mailing address.
    (c) An application for exemption under this section shall contain 
the following information:
    (1) The name, address, and registration number, if any, of the 
applicant;
    (2) The date of the application;
    (3) The exact trade name(s) of the applicant's chemical mixture and:
    (i) If the applicant formulates or manufactures the chemical mixture 
for other entities, the exact trade names of the chemical mixtures and 
the names of the entities for which the chemical mixtures were prepared; 
and
    (ii) If a group of mixtures (e.g. formulations having identical 
function and containing the same listed chemical(s)), the information 
required in paragraph (c)(3)(i) of this section and a brief narrative of 
their use.
    (4) (i) The complete qualitative and quantitative composition of the 
chemical mixture (including all listed and all non-listed chemicals); or
    (ii) If a group of mixtures, the concentration range for the listed 
chemical and a listing of all non-listed chemicals with respective 
concentration ranges.
    (5) (i) The chemical and physical properties of the mixture and how 
they differ from the properties of the listed chemical or chemicals; and
    (ii) If a group of mixtures, how the group's properties differ from 
the properties of the listed chemical.
    (6) A statement that the applicant believes justifies an exemption 
for the chemical mixture or group of mixtures. The statement must 
explain how the chemical mixture(s) meets the exemption criteria set 
forth in paragraph (a) of this section.
    (7) A statement that the applicant accepts the right of the 
Administrator to terminate exemption from regulation for the chemical 
mixture(s) granted exemption under this section.
    (8) The identification of any information on the application that is 
considered by the applicant to be a trade secret or confidential and 
entitled to protection under U.S. laws restricting the public disclosure 
of such information.
    (d) The Administrator may require the applicant to submit such 
additional documents or written statements of fact relevant to the 
application that he deems necessary for determining if the application 
should be granted.
    (e) Within a reasonable period of time after the receipt of an 
application for an exemption under this section, the Administrator will 
notify the applicant in writing of the acceptance or rejection of the 
application for filing. If the application is not accepted for filing, 
an explanation will be provided. The Administrator is not required to 
accept an application if any information required pursuant to paragraph 
(c) of this section or requested pursuant to paragraph (d) of this 
section is lacking

[[Page 160]]

or not readily understood. The applicant may, however, amend the 
application to meet the requirements of paragraphs (c) and (d) of this 
section. If the exemption is subsequently granted, the applicant shall 
again be notified in writing and the Administrator shall issue, and 
publish in the Federal Register, an order on the application. This order 
shall specify the date on which it shall take effect. The Administrator 
shall permit any interested person to file written comments on or 
objections to the order. If any comments or objections raise significant 
issues regarding any findings of fact or conclusions of law upon which 
the order is based, the Administrator may suspend the effectiveness of 
the order until he has reconsidered the application in light of the 
comments and objections filed. Thereafter, the Administrator shall 
reinstate, terminate, or amend the original order as deemed appropriate.
    (f) The Administrator may, at any time, terminate or modify an 
exemption for any product pursuant to paragraph (e) of this section. In 
terminating or modifying an exemption, the Administrator shall issue, 
and publish in the Federal Register, notification of the removal of an 
exempt product or group of exempt products for which evidence of 
diversion has been found. This order shall specify the date on which the 
termination of exemption shall take effect. The Administrator shall 
permit any interested party to file written comments on or objections to 
the order within 60 days of the date of publication of the order in the 
Federal Register. If any such comments or objections raise significant 
issues regarding any finding of fact or conclusion of law upon which the 
order is based, the Administrator may suspend the effectiveness of the 
order until he has reconsidered the order in light of comments and 
objections filed. Thereafter, the Administrator shall reinstate, 
terminate, or amend the original order as determined appropriate.
    (g) A manufacturer of an exempted chemical mixture shall notify DEA 
in writing, of any change in the quantitative or qualitative composition 
of a chemical mixture that has been granted an exemption by application. 
Changes include those greater than the range of concentration given in 
the application or that remove non-listed chemical(s) given in the 
application as part of the formulation. A new application will be 
required only if reformulation results in a new product having a 
different commercial application or can no longer be defined as part of 
a group of exempted chemicals. DEA must be notified of reformulation at 
least 30 days in advance of marketing the reformulated mixture. For a 
change in name or other designation, code, or any identifier, a written 
notification is required. DEA must be notified of any changes at least 
60 days in advance of the effective date for the change.
    (h) Each manufacturer seeking exemption must apply for such an 
exemption. A formulation granted exemption by publication in the Federal 
Register will not be exempted for all manufacturers.
    (i) The following chemical mixtures, in the form and quantity listed 
in the application submitted (indicated as the ``date'') are designated 
as exempt chemical mixtures for the purposes set forth in this section 
and are exempted by the Administrator from application of Sections 302, 
303, 310, 1007, 1008, and 1018 of the Act (21 U.S.C. 822, 823, 830, 957, 
958, and 971):

                                            Exempt Chemical Mixtures
----------------------------------------------------------------------------------------------------------------
            Manufacturer                         Product name \1\                      Form              Date
----------------------------------------------------------------------------------------------------------------
Cerilliant Corporation..............  1R,2S(-)-Ephedrine hydrochloride 1.0    Liquid...............     8/2/2007
                                       mg/ml as free base in one of: 1,2-
                                       dimethoxyethane, acetonitrile,
                                       acetonitrile: water (=50%
                                       acetonitrile), dimethylformamide,
                                       ethylene glycol, isopropanol,
                                       methanol, methanol/water (50:50),
                                       methanol/dimethyl sulfoxide (80:20),
                                       methylene chloride, or
                                       tetrahydrofuran.
Cerilliant Corporation..............  1S,2R(+)-Ephedrine-D3 hydrochloride     Liquid...............     8/2/2007
                                       0.1 mg/ml as free base in one of: 1,2-
                                       dimethoxyethane, acetonitrile,
                                       acetonitrile: water (>=50%
                                       acetonitrile), dimethylformamide,
                                       ethylene glycol, isopropanol,
                                       methanol, methanol/water (50:50),
                                       methanol/dimethyl sulfoxide (80:20),
                                       methylene chloride, or
                                       tetrahydrofuran.

[[Page 161]]

 
Cerilliant Corporation..............  1S,2R(+)-Ephedrine-D3 hydrochloride     Liquid...............     8/2/2007
                                       1.0 mg/ml as free base in one of: 1,2-
                                       dimethoxyethane, acetonitrile,
                                       acetonitrile: water (>=50%
                                       acetonitrile), dimethylformamide,
                                       ethylene glycol, isopropanol,
                                       methanol, methanol/water (50:50),
                                       methanol/dimethyl sulfoxide (80:20),
                                       methylene chloride, or
                                       tetrahydrofuran.
Cerilliant Corporation..............  1S,2R(+)-Ephedrine hydrochloride 1.0    Liquid...............     8/2/2007
                                       mg/ml as free base in one of: 1,2-
                                       dimethoxyethane, acetonitrile,
                                       acetonitrile: water (=50%
                                       acetonitrile), dimethylformamide,
                                       ethylene glycol, isopropanol,
                                       methanol, methanol/water (50:50),
                                       methanol/dimethyl sulfoxide (80:20),
                                       methylene chloride, or
                                       tetrahydrofuran.
Cerilliant Corporation..............  Pseudoephedrine-D3 hydrochloride 0.1    Liquid...............     8/2/2007
                                       mg/ml as free base in one of: 1,2-
                                       dimethoxyethane, acetonitrile,
                                       acetonitrile: water (>=50%
                                       acetonitrile), dimethylformamide,
                                       ethylene glycol, isopropanol,
                                       methanol, methanol/water (50:50),
                                       methanol/dimethyl sulfoxide (80:20),
                                       methylene chloride, or
                                       tetrahydrofuran.
Cerilliant Corporation..............  R,R(-)-Pseudoephedrine 1.0 mg/ml as     Liquid...............     8/2/2007
                                       free base in one of: 1,2-
                                       dimethoxyethane, acetonitrile,
                                       acetonitrile: water (=50%
                                       acetonitrile), dimethylformamide,
                                       ethylene glycol, isopropanol,
                                       methanol, methanol/water (50:50),
                                       methanol/dimethyl sulfoxide (80:20)
                                       methylene chloride, or
                                       tetrahydrofuran.
Cerilliant Corporation..............  S,S(+)-Pseudoephedrine 1.0 mg/ml as     Liquid...............     8/2/2007
                                       free base in one of: 1,2-
                                       dimethoxyethane, acetonitrile,
                                       acetonitrile: water (=50%
                                       acetonitrile), dimethylformamide,
                                       ethylene glycol, isopropanol,
                                       methanol, methanol/water (50:50),
                                       methanol/dimethyl sulfoxide (80:20),
                                       methylene chloride, or
                                       tetrahydrofuran.
E.I. DuPont deNemours & Co..........  RC-5156...............................  Liquid...............    4/22/2005
E.I. DuPont deNemours & Co..........  VH-6037...............................  Liquid...............    4/22/2005
Hawthorne Products, Inc.............  Sole Pack Hoof Dressing...............  Paste................    8/14/2007
Hawthorne Products, Inc.............  Sole Pack Hoof Packing................  Paste................    8/14/2007
Quality Assurance Service             10 to 1000 nanograms per milliliter of  Liquid...............    9/26/2007
 Corporation.                          ephedrine in blood, serum, or urine.
Quality Assurance Service             10 to 1000 nanograms per milliliter of  Liquid...............    9/26/2007
 Corporation.                          pseudoephedrine in blood, serum, or
                                       urine.
Quality Assurance Service             10 to 1000 nanograms per milliliter of  Liquid...............    9/26/2007
 Corporation.                          phenylpropanolamine in blood, serum,
                                       or urine.
Reichhold, Inc......................  Beckosol[supreg] 12021-00 AA-200, IA-   Liquid...............    5/05/2005
                                       441, P531-T.
Reichhold, Inc......................  Urotuf[supreg] L06-30S, F78-50T.......  Liquid...............    5/05/2005
Reichhold, Inc......................  Beckosol AA-220.......................  Liquid...............    6/14/2005
Waterbury Companies, Inc............  Waterbury 332500......................  Liquid...............    4/11/2005
Waterbury Companies, Inc............  Waterbury 332762......................  Liquid...............    4/11/2005
Waterbury Companies, Inc............  Waterbury 332400......................  Liquid...............    4/11/2005
Waterbury Companies, Inc............  Waterbury 346201......................  Liquid...............    4/11/2005
----------------------------------------------------------------------------------------------------------------
\1\ Designate product line if a group.


[68 FR 23204, May 1, 2003, as amended at 75 FR 10681, Mar. 9, 2010; 75 
FR 53869, Sept. 2, 2010; 76 FR 31830, June 2, 2011]



Sec. 1310.14  Removal of exemption from definition of regulated 
transaction.

    The Administrator finds that the following drugs or groups of drugs 
are being diverted to obtain a listed chemical for use in the illicit 
production of a controlled substance and removes the drugs or groups of 
drugs from exemption under paragraph (1)(iv) of the definition of 
regulated transaction in Sec. 1300.02 of this chapter pursuant to the 
criteria listed in Sec. 1310.10 of this part:
    (a) Nonprescription drugs containing ephedrine, its salts, optical 
isomers, and salts of optical isomers.
    (b) Nonprescription drugs containing phenylpropanolamine, its salts, 
optical isomers, and salts of optical isomers.
    (c) Nonprescription drugs containing pseudoephedrine, its salts, 
optical isomers, and salts of optical isomers.

[75 FR 38922, July 7, 2010, as amended at 77 FR 4237, Jan. 27, 2012]

[[Page 162]]



Sec. 1310.16  Exemptions for certain scheduled listed chemical 
products.

    (a) Upon the application of a manufacturer of a scheduled listed 
chemical product, the Administrator may by regulation provide that the 
product is exempt from part 1314 of this chapter if the Administrator 
determines that the product cannot be used in the illicit manufacture of 
a controlled substance.
    (b) An application for an exemption under this section must contain 
all of the following information:
    (1) The name and address of the applicant.
    (2) The exact trade name of the scheduled listed chemical product 
for which exemption is sought.
    (3) The complete quantitative and qualitative composition of the 
drug product.
    (4) A brief statement of the facts that the applicant believes 
justify the granting of an exemption under this section.
    (5) Certification by the applicant that the product may be lawfully 
marketed or distributed under the Federal, Food, Drug, and Cosmetic Act.
    (6) The identification of any information on the application that is 
considered by the applicant to be a trade secret or confidential and 
entitled to protection under U.S. laws restricting the public disclosure 
of such information by government employees.
    (c) The Administrator may require the applicant to submit additional 
documents or written statements of fact relevant to the application that 
he deems necessary for determining if the application should be granted.
    (d) Within a reasonable period of time after the receipt of a 
completed application for an exemption under this section, the 
Administrator shall notify the applicant of acceptance or non-acceptance 
of the application. If the application is not accepted, an explanation 
will be provided. The Administrator is not required to accept an 
application if any of the information required in paragraph (b) of this 
section or requested under paragraph (c) of this section is lacking or 
not readily understood. The applicant may, however, amend the 
application to meet the requirements of paragraphs (b) and (c) of this 
section.
    (e) If the application is accepted for filing, the Administrator 
shall issue and publish in the Federal Register an order on the 
application, which shall include a reference to the legal authority 
under which the order is based. This order shall specify the date on 
which it shall take effect.
    (f) The Administrator shall permit any interested person to file 
written comments on or objections to the order. If any comments or 
objections raise significant issues regarding any findings of fact or 
conclusions of law upon which the order is based, the Administrator 
shall immediately suspend the effectiveness of the order until he may 
reconsider the application in light of the comments and objections 
filed. Thereafter, the Administrator shall reinstate, revoke, or amend 
the original order as deemed appropriate.

[71 FR 56024, Sept. 26, 2006]



Sec. 1310.21  Sale by Federal departments or agencies of chemicals
which could be used to manufacture controlled substances.

    (a) A Federal department or agency may not sell from the stocks of 
the department or agency any chemical which, as determined by the 
Administrator of the Drug Enforcement Administration, could be used in 
the manufacture of a controlled substance, unless the Administrator 
certifies in writing to the head of the department or agency that there 
is no reasonable cause to believe that the sale of the specific chemical 
to a specific person would result in the illegal manufacture of a 
controlled substance. For purposes of this requirement, reasonable cause 
to believe means that the Administration has knowledge of facts which 
would cause a reasonable person to reasonably conclude that a chemical 
would be diverted to the illegal manufacture of a controlled substance.
    (b) A Federal department or agency must request certification by 
submitting a written request to the Administrator, Drug Enforcement 
Administration. See the Table of DEA Mailing Addresses in Sec. 1321.01 
of this chapter for the current mailing address. A request for 
certification may be transmitted

[[Page 163]]

directly to the Office of Diversion Control, Drug Enforcement 
Administration, through electronic facsimile media. A request for 
certification must be submitted no later than fifteen calendar days 
before the proposed sale is to take place. In order to facilitate the 
sale of chemicals from Federal departments' or agencies' stocks, Federal 
departments or agencies may wish to submit requests as far in advance of 
the fifteen calendar days as possible. The written notification of the 
proposed sale must include:
    (1) The name and amount of the chemical to be sold;
    (2) The name and address of the prospective bidder;
    (3) The name and address of the prospective end-user, in cases where 
a sale is being brokered;
    (4) Point(s) of contact for the prospective bidder and, where 
appropriate, prospective end-user; and
    (5) The end use of the chemical.
    (c) Within fifteen calendar days of receipt of a request for 
certification, the Administrator will certify in writing to the head of 
the Federal department or agency that there is, or is not, reasonable 
cause to believe that the sale of the specific chemical to the specific 
bidder and end-user would result in the illegal manufacture of a 
controlled substance. In making this determination, the following 
factors must be considered:
    (1) Past experience of the prospective bidder or end-user in the 
maintenance of effective controls against diversion of listed chemicals 
into other than legitimate medical, scientific, and industrial channels;
    (2) Compliance of the prospective bidder or end-user with applicable 
Federal, state and local law;
    (3) Prior conviction record of the prospective bidder or end-user 
relating to listed chemicals or controlled substances under Federal or 
state laws; and
    (4) Such other factors as may be relevant to and consistent with the 
public health and safety.
    (d) If the Administrator certifies to the head of a Federal 
department or agency that there is no reasonable cause to believe that 
the sale of a specific chemical to a prospective bidder and end-user 
will result in the illegal manufacture of a controlled substance, that 
certification will be effective for one year from the date of issuance 
with respect to further sales of the same chemical to the same 
prospective bidder and end-user, unless the Administrator notifies the 
head of the Federal department or agency in writing that the 
certification is withdrawn. If the certification is withdrawn, DEA will 
also provide written notice to the bidder and end-user, which will 
contain a statement of the legal and factual basis for this 
determination.
    (e) If the Administrator determines there is reasonable cause to 
believe the sale of the specific chemical to a specific bidder and end-
user would result in the illegal manufacture of a controlled substance, 
DEA will provide written notice to the head of a Federal department or 
agency refusing to certify the proposed sale under the authority of 21 
U.S.C. 890. DEA also will provide, within fifteen calendar days of 
receiving a request for certification from a Federal department or 
agency, the same written notice to the prospective bidder and end-user, 
and this notice also will contain a statement of the legal and factual 
basis for the refusal of certification. The prospective bidder and end-
user may, within thirty calendar days of receipt of notification of the 
refusal, submit written comments or written objections to the 
Administrator's refusal. At the same time, the prospective bidder and 
end-user also may provide supporting documentation to contest the 
Administrator's refusal. If such written comments or written objections 
raise issues regarding any finding of fact or conclusion of law upon 
which the refusal is based, the Administrator will reconsider the 
refusal of the proposed sale in light of the written comments or written 
objections filed. Thereafter, within a reasonable time, the 
Administrator will withdraw or affirm the original refusal of 
certification as he determines appropriate. The Administrator will 
provide written reasons for any affirmation of the original refusal. 
Such affirmation of the original refusal will constitute a final 
decision for purposes of judicial review under 21 U.S.C. 877.

[[Page 164]]

    (f) If the Administrator determines there is reasonable cause to 
believe that an existing certification should be withdrawn, DEA will 
provide written notice to the head of a Federal department or agency of 
such withdrawal under the authority of 21 U.S.C. 890. DEA also will 
provide, within fifteen calendar days of withdrawal of an existing 
certification, the same written notice to the bidder and end-user, and 
this notice also will contain a statement of the legal and factual basis 
for the withdrawal. The bidder and end-user may, within thirty calendar 
days of receipt of notification of the withdrawal of the existing 
certification, submit written comments or written objections to the 
Administrator's withdrawal. At the same time, the bidder and end-user 
also may provide supporting documentation to contest the Administrator's 
withdrawal. If such written comments or written objections raise issues 
regarding any finding of fact or conclusion of law upon which the 
withdrawal of the existing certification is based, the Administrator 
will reconsider the withdrawal of the existing certification in light of 
the written comments or written objections filed. Thereafter, within a 
reasonable time, the Administrator will withdraw or affirm the original 
withdrawal of the existing certification as he determines appropriate. 
The Administrator will provide written reasons for any affirmation of 
the original withdrawal of the existing certification. Such affirmation 
of the original withdrawal of the existing certification will constitute 
a final decision for purposes of judicial review under 21 U.S.C. 877.

[68 FR 62737, Nov. 6, 2003, as amended at 75 FR 10681, Mar. 9, 2010]



PART 1311_REQUIREMENTS FOR ELECTRONIC ORDERS AND PRESCRIPTIONS--Table
of Contents



                            Subpart A_General

Sec.
1311.01 Scope.
1311.02 Definitions.
1311.05 Standards for technologies for electronic transmission of 
          orders.
1311.08 Incorporation by reference.

Subpart B_Obtaining and Using Digital Certificates for Electronic Orders

1311.10 Eligibility to obtain a CSOS digital certificate.
1311.15 Limitations on CSOS digital certificates.
1311.20 Coordinators for CSOS digital certificate holders.
1311.25 Requirements for obtaining a CSOS digital certificate.
1311.30 Requirements for storing and using a private key for digitally 
          signing orders.
1311.35 Number of CSOS digital certificates needed.
1311.40 Renewal of CSOS digital certificates.
1311.45 Requirements for registrants that allow powers of attorney to 
          obtain CSOS digital certificates under their DEA registration.
1311.50 Requirements for recipients of digitally signed orders.
1311.55 Requirements for systems used to process digitally signed 
          orders.
1311.60 Recordkeeping.

                   Subpart C_Electronic Prescriptions

1311.100 General.
1311.102 Practitioner responsibilities.
1311.105 Requirements for obtaining an authentication credential--
          Individual practitioners.
1311.110 Requirements for obtaining an authentication credential--
          Individual practitioners eligible to use an electronic 
          prescription application of an institutional practitioner.
1311.115 Additional requirements for two-factor authentication.
1311.116 Additional requirements for biometrics.
1311.120 Electronic prescription application requirements.
1311.125 Requirements for establishing logical access control--
          Individual practitioner.
1311.130 Requirements for establishing logical access control--
          Institutional practitioner.
1311.135 Requirements for creating a controlled substance prescription.
1311.140 Requirements for signing a controlled substance prescription.
1311.145 Digitally signing the prescription with the individual 
          practitioner's private key.
1311.150 Additional requirements for internal application audits.
1311.170 Transmission requirements.
1311.200 Pharmacy responsibilities.
1311.205 Pharmacy application requirements.
1311.210 Archiving the initial record.
1311.215 Internal audit trail.

[[Page 165]]

1311.300 Application provider requirements--Third-party audits or 
          certifications.
1311.302 Additional application provider requirements.
1311.305 Recordkeeping.

    Authority: 21 U.S.C. 821, 828, 829, 871(b), 958(e), 965, unless 
otherwise noted.

    Source: 70 FR 16915, Apr. 1, 2005, unless otherwise noted.



                            Subpart A_General



Sec. 1311.01  Scope.

    This part sets forth the rules governing the creation, transmission, 
and storage of electronic orders and prescriptions.

[75 FR 16310, Mar. 31, 2010]



Sec. 1311.02  Definitions.

    Any term contained in this part shall have the definition set forth 
in section 102 of the Act (21 U.S.C. 802) or part 1300 of this chapter.

[75 FR 16310, Mar. 31, 2010]



Sec. 1311.05  Standards for technologies for electronic transmission of
orders.

    (a) A registrant or a person with power of attorney to sign orders 
for Schedule I and II controlled substances may use any technology to 
sign and electronically transmit orders if the technology provides all 
of the following:
    (1) Authentication: The system must enable a recipient to positively 
verify the signer without direct communication with the signer and 
subsequently demonstrate to a third party, if needed, that the sender's 
identity was properly verified.
    (2) Nonrepudiation: The system must ensure that strong and 
substantial evidence is available to the recipient of the sender's 
identity, sufficient to prevent the sender from successfully denying 
having sent the data. This criterion includes the ability of a third 
party to verify the origin of the document.
    (3) Message integrity: The system must ensure that the recipient, or 
a third party, can determine whether the contents of the document have 
been altered during transmission or after receipt.
    (b) DEA has identified the following means of electronically signing 
and transmitting order forms as meeting all of the standards set forth 
in paragraph (a) of this section.
    (1) Digital signatures using Public Key Infrastructure (PKI) 
technology.
    (2) [Reserved]



Sec. 1311.08  Incorporation by reference.

    (a) These incorporations by reference were approved by the Director 
of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR 
part 51. Copies may be inspected at the Drug Enforcement Administration, 
600 Army Navy Drive, Arlington, VA 22202 or at the National Archives and 
Records Administration (NARA). For information on the availability of 
this material at the Drug Enforcement Administration, call (202) 307-
1000. For information on the availability of this material at NARA, call 
(202) 741-6030 or go to: http://www.archives.gov/federal--register/
code--of--federal--regulations/ibr--locations.html.
    (b) These standards are available from the National Institute of 
Standards and Technology, Computer Security Division, Information 
Technology Laboratory, National Institute of Standards and Technology, 
100 Bureau Drive, Gaithersburg, MD 20899-8930, (301) 975-6478 or TTY 
(301) 975-8295, [email protected], and are available at http://
csrc.nist.gov/. The following standards are incorporated by reference:
    (1) Federal Information Processing Standard Publication (FIPS PUB) 
140-2, Change Notices (12-03-2002), Security Requirements for 
Cryptographic Modules, May 25, 2001 (FIPS 140-2) including Annexes A 
through D; incorporation by reference approved for Sec. Sec. 
1311.30(b), 1311.55(b), 1311.115(b), 1311.120(b), 1311.205(b).
    (i) Annex A: Approved Security Functions for FIPS PUB 140-2, 
Security Requirements for Cryptographic Modules, September 23, 2004.
    (ii) Annex B: Approved Protection Profiles for FIPS PUB 140-2, 
Security Requirements for Cryptographic Modules, November 4, 2004.
    (iii) Annex C: Approved Random Number Generators for FIPS PUB 140-2, 
Security Requirements for Cryptographic Modules, January 31, 2005.

[[Page 166]]

    (iv) Annex D: Approved Key Establishment Techniques for FIPS PUB 
140-2, Security Requirements for Cryptographic Modules, February 23, 
2004.
    (2) Federal Information Processing Standard Publication (FIPS PUB) 
180-2, Secure Hash Standard, August 1, 2002, as amended by change notice 
1, February 25, 2004 (FIPS 180-2); incorporation by reference approved 
for Sec. Sec. 1311.30(b) and 1311.55(b).
    (3) Federal Information Processing Standard Publication (FIPS PUB) 
180-3, Secure Hash Standard (SHS), October 2008 (FIPS 180-3); 
incorporation by reference approved for Sec. Sec. 1311.120(b) and 
1311.205(b).
    (4) Federal Information Processing Standard Publication (FIPS PUB) 
186-2, Digital Signature Standard, January 27, 2000, as amended by 
Change Notice 1, October 5, 2001 (FIPS 186-2); incorporation by 
reference approved for Sec. Sec. 1311.30(b) and 1311.55(b).
    (5) Federal Information Processing Standard Publication (FIPS PUB) 
186-3, Digital Signature Standard (DSS), June 2009 (FIPS 186-3); 
incorporation by reference approved for Sec. Sec. 1311.120(b), 
1311.205(b), and 1311.210(c).
    (6) Draft NIST Special Publication 800-63-1, Electronic 
Authentication Guideline, December 8, 2008 (NIST SP 800-63-1); Burr, W. 
et al.; incorporation by reference approved for Sec. 1311.105(a).
    (7) NIST Special Publication 800-76-1, Biometric Data Specification 
for Personal Identity Verification, January 2007 (NIST SP 800-76-1); 
Wilson, C. et al.; incorporation by reference approved for Sec. 
1311.116(d).

[75 FR 16310, Mar. 31, 2010]



Subpart B_Obtaining and Using Digital Certificates for Electronic Orders



Sec. 1311.10  Eligibility to obtain a CSOS digital certificate.

    The following persons are eligible to obtain a CSOS digital 
certificate from the DEA Certification Authority to sign electronic 
orders for controlled substances.
    (a) The person who signed the most recent DEA registration 
application or renewal application and a person authorized to sign a 
registration application.
    (b) A person granted power of attorney by a DEA registrant to sign 
orders for one or more schedules of controlled substances.



Sec. 1311.15  Limitations on CSOS digital certificates.

    (a) A CSOS digital certificate issued by the DEA Certification 
Authority will authorize the certificate holder to sign orders for only 
those schedules of controlled substances covered by the registration 
under which the certificate is issued.
    (b) When a registrant, in a power of attorney letter, limits a 
certificate applicant to a subset of the registrant's authorized 
schedules, the registrant is responsible for ensuring that the 
certificate holder signs orders only for that subset of schedules.



Sec. 1311.20  Coordinators for CSOS digital certificate holders.

    (a) Each registrant, regardless of number of digital certificates 
issued, must designate one or more responsible persons to serve as that 
registrant's CSOS coordinator regarding issues pertaining to issuance 
of, revocation of, and changes to digital certificates issued under that 
registrant's DEA registration. While the coordinator will be the main 
point of contact between one or more DEA registered locations and the 
CSOS Certification Authority, all digital certificate activities are the 
responsibility of the registrant with whom the digital certificate is 
associated. Even when an individual registrant, i.e., an individual 
practitioner, is applying for a digital certificate to order controlled 
substances a CSOS Coordinator must be designated; though in such a case, 
the individual practitioner may also serve as the coordinator.
    (b) Once designated, coordinators must identify themselves, on a 
one-time basis, to the Certification Authority. If a designated 
coordinator changes, the Certification Authority must be notified of the 
change and the new responsibilities assumed by each of the registrant's 
coordinators, if applicable. Coordinators must complete the application 
that the DEA Certification

[[Page 167]]

Authority provides and submit the following:
    (1) Two copies of identification, one of which must be a government-
issued photographic identification.
    (2) A copy of each current DEA Certificate of Registration (DEA form 
223) for each registered location for which the coordinator will be 
responsible or, if the applicant (or their employer) has not been issued 
a DEA registration, a copy of each application for registration of the 
applicant or the applicant's employer.
    (3) The applicant must have the completed application notarized and 
forward the completed application and accompanying documentation to the 
DEA Certification Authority.
    (c) Coordinators will communicate with the Certification Authority 
regarding digital certificate applications, renewals and revocations. 
For applicants applying for a digital certificate from the DEA 
Certification Authority, and for applicants applying for a power of 
attorney digital certificate for a DEA registrant, the registrant's 
Coordinator must verify the applicant's identity, review the application 
package, and submit the completed package to the Certification 
Authority.



Sec. 1311.25  Requirements for obtaining a CSOS digital certificate.

    (a) To obtain a certificate to use for signing electronic orders for 
controlled substances, a registrant or person with power of attorney for 
a registrant must complete the application that the DEA Certification 
Authority provides and submit the following:
    (1) Two copies of identification, one of which must be a government-
issued photographic identification.
    (2) A current listing of DEA registrations for which the individual 
has authority to sign controlled substances orders.
    (3) A copy of the power of attorney from the registrant, if 
applicable.
    (4) An acknowledgment that the applicant has read and understands 
the Subscriber Agreement and agrees to the statement of subscriber 
obligations that DEA provides.
    (b) The applicant must provide the completed application to the 
registrant's coordinator for CSOS digital certificate holders who will 
review the application and submit the completed application and 
accompanying documentation to the DEA Certification Authority.
    (c) When the Certification Authority approves the application, it 
will send the applicant a one-time use reference number and access code, 
via separate channels, and information on how to use them. Using this 
information, the applicant must then electronically submit a request for 
certification of the public digital signature key. After the request is 
approved, the Certification Authority will provide the applicant with 
the signed public key certificate.
    (d) Once the applicant has generated the key pair, the Certification 
Authority must prove that the user has possession of the key. For public 
keys, the corresponding private key must be used to sign the certificate 
request. Verification of the signature using the public key in the 
request will serve as proof of possession of the private key.



Sec. 1311.30  Requirements for storing and using a private key for 
digitally signing orders.

    (a) Only the certificate holder may access or use his or her digital 
certificate and private key.
    (b) The certificate holder must provide FIPS-approved secure storage 
for the private key, as discussed by FIPS 140-2, 180-2, 186-2, and 
accompanying change notices and annexes, as incorporated by reference in 
Sec. 1311.08.
    (c) A certificate holder must ensure that no one else uses the 
private key. While the private key is activated, the certificate holder 
must prevent unauthorized use of that private key.
    (d) A certificate holder must not make back-up copies of the private 
key.
    (e) The certificate holder must report the loss, theft, or 
compromise of the private key or the password, via a revocation request, 
to the Certification Authority within 24 hours of substantiation of the 
loss, theft, or compromise. Upon receipt and verification of a signed 
revocation request, the Certification Authority will revoke the 
certificate. The certificate holder must apply for a new certificate 
under the requirements of Sec. 1311.25.

[[Page 168]]



Sec. 1311.35  Number of CSOS digital certificates needed.

    A purchaser of Schedule I and II controlled substances must obtain a 
separate CSOS certificate for each registered location for which the 
purchaser will order these controlled substances.



Sec. 1311.40  Renewal of CSOS digital certificates.

    (a) A CSOS certificate holder must generate a new key pair and 
obtain a new CSOS digital certificate when the registrant's DEA 
registration expires or whenever the information on which the 
certificate is based changes. This information includes the registered 
name and address, the subscriber's name, and the schedules the 
registrant is authorized to handle. A CSOS certificate will expire on 
the date on which the DEA registration on which the certificate is based 
expires.
    (b) The Certification Authority will notify each CSOS certificate 
holder 45 days in advance of the expiration of the certificate holder's 
CSOS digital certificate.
    (c) If a CSOS certificate holder applies for a renewal before the 
certificate expires, the certificate holder may renew electronically 
twice. For every third renewal, the CSOS certificate holder must submit 
a new application and documentation, as provided in Sec. 1311.25.
    (d) If a CSOS certificate expires before the holder applies for a 
renewal, the certificate holder must submit a new application and 
documentation, as provided in Sec. 1311.25.



Sec. 1311.45  Requirements for registrants that allow powers of attorney
to obtain CSOS digital certificates under their DEA registration.

    (a) A registrant that grants power of attorney must report to the 
DEA Certification Authority within 6 hours of either of the following 
(advance notice may be provided, where applicable):
    (1) The person with power of attorney has left the employ of the 
institution.
    (2) The person with power of attorney has had his or her privileges 
revoked.
    (b) A registrant must maintain a record that lists each person 
granted power of attorney to sign controlled substances orders.



Sec. 1311.50  Requirements for recipients of digitally signed orders.

    (a) The recipient of a digitally signed order must do the following 
before filling the order:
    (1) Verify the integrity of the signature and the order by having 
the system validate the order.
    (2) Verify that the certificate holder's CSOS digital certificate 
has not expired by checking the expiration date against the date the 
order was signed.
    (3) Check the validity of the certificate holder's certificate by 
checking the Certificate Revocation List.
    (4) Check the certificate extension data to determine whether the 
sender has the authority to order the controlled substance.
    (b) A recipient may cache Certificate Revocation Lists for use until 
they expire.



Sec. 1311.55  Requirements for systems used to process digitally signed
orders.

    (a) A CSOS certificate holder and recipient of an electronic order 
may use any system to write, track, or maintain orders provided that the 
system has been enabled to process digitally signed documents and that 
it meets the requirements of paragraph (b) or (c) of this section.
    (b) A system used to digitally sign Schedule I or II orders must 
meet the following requirements:
    (1) The cryptographic module must be FIPS 140-2, Level 1 validated, 
as incorporated by reference in Sec. 1311.08.
    (2) The digital signature system and hash function must be compliant 
with FIPS 186-2 and FIPS 180-2, as incorporated by reference in Sec. 
1311.08.
    (3) The private key must be stored on a FIPS 140-2 Level 1 validated 
cryptographic module using a FIPS-approved encryption algorithm, as 
incorporated by reference in Sec. 1311.08.
    (4) The system must use either a user identification and password 
combination or biometric authentication to access the private key. 
Activation data must not be displayed as they are entered.

[[Page 169]]

    (5) The system must set a 10-minute inactivity time period after 
which the certificate holder must reauthenticate the password to access 
the private key.
    (6) For software implementations, when the signing module is 
deactivated, the system must clear the plain text private key from the 
system memory to prevent the unauthorized access to, or use of, the 
private key.
    (7) The system must be able to digitally sign and transmit an order.
    (8) The system must have a time system that is within five minutes 
of the official National Institute of Standards and Technology time 
source.
    (9) The system must archive the digitally signed orders and any 
other records required in part 1305 of this chapter, including any 
linked data.
    (10) The system must create an order that includes all data fields 
listed under Sec. 1305.21(b) of this chapter.
    (c) A system used to receive, verify, and create linked records for 
orders signed with a CSOS digital certificate must meet the following 
requirements:
    (1) The cryptographic module must be FIPS 140-2, Level 1 validated, 
as incorporated by reference in Sec. 1311.08.
    (2) The digital signature system and hash function must be compliant 
with FIPS 186-2 and FIPS 180-2, as incorporated by reference in Sec. 
1311.08.
    (3) The system must determine that an order has not been altered 
during transmission. The system must invalidate any order that has been 
altered.
    (4) The system must validate the digital signature using the 
signer's public key. The system must invalidate any order in which the 
digital signature cannot be validated.
    (5) The system must validate that the DEA registration number 
contained in the body of the order corresponds to the registration 
number associated with the specific certificate by separately generating 
the hash value of the registration number and certificate subject 
distinguished name serial number and comparing that hash value to the 
hash value contained in the certificate extension for the DEA 
registration number. If the hash values are not equal the system must 
invalidate the order.
    (6) The system must check the Certificate Revocation List 
automatically and invalidate any order with a certificate listed on the 
Certificate Revocation List.
    (7) The system must check the validity of the certificate and the 
Certification Authority certificate and invalidate any order that fails 
these validity checks.
    (8) The system must have a time system that is within five minutes 
of the official National Institute of Standards and Technology time 
source.
    (9) The system must check the substances ordered against the 
schedules that the registrant is allowed to order and invalidate any 
order that includes substances the registrant is not allowed to order.
    (10) The system must ensure that an invalid finding cannot be 
bypassed or ignored and the order filled.
    (11) The system must archive the order and associate with it the 
digital certificate received with the order.
    (12) If a registrant sends reports on orders to DEA, the system must 
create a report in the format DEA specifies, as provided in Sec. 
1305.29 of this chapter.
    (d) For systems used to process CSOS orders, the system developer or 
vendor must have an initial independent third-party audit of the system 
and an additional independent third-party audit whenever the signing or 
verifying functionality is changed to determine whether it correctly 
performs the functions listed under paragraphs (b) and (c) of this 
section. The system developer must retain the most recent audit results 
and retain the results of any other audits of the software completed 
within the previous two years.



Sec. 1311.60  Recordkeeping.

    (a) A supplier and purchaser must maintain records of CSOS 
electronic orders and any linked records for two years. Records may be 
maintained electronically. Records regarding controlled substances that 
are maintained electronically must be readily retrievable from all other 
records.
    (b) Electronic records must be easily readable or easily rendered 
into a format that a person can read. They must be made available to the 
Administration upon request.
    (c) CSOS certificate holders must maintain a copy of the subscriber

[[Page 170]]

agreement that the Certification Authority provides for the life of the 
certificate.



                   Subpart C_Electronic Prescriptions

    Source: 75 FR 16310, Mar. 31, 2010, unless otherwise noted.



Sec. 1311.100  General.

    (a) This subpart addresses the requirements that must be met to 
issue and process Schedule II, III, IV, and V controlled substance 
prescriptions electronically.
    (b) A practitioner may issue a prescription for a Schedule II, III, 
IV, or V controlled substance electronically if all of the following 
conditions are met:
    (1) The practitioner is registered as an individual practitioner or 
exempt from the requirement of registration under part 1301 of this 
chapter and is authorized under the registration or exemption to 
dispense the controlled substance;
    (2) The practitioner uses an electronic prescription application 
that meets all of the applicable requirements of this subpart; and
    (3) The prescription is otherwise in conformity with the 
requirements of the Act and this chapter.
    (c) An electronic prescription for a Schedule II, III, IV, or V 
controlled substance created using an electronic prescription 
application that does not meet the requirements of this subpart is not a 
valid prescription, as that term is defined in Sec. 1300.03 of this 
chapter.
    (d) A controlled substance prescription created using an electronic 
prescription application that meets the requirements of this subpart is 
not a valid prescription if any of the functions required under this 
subpart were disabled when the prescription was indicated as ready for 
signature and signed.
    (e) A registered pharmacy may process electronic prescriptions for 
controlled substances only if all of the following conditions are met:
    (1) The pharmacy uses a pharmacy application that meets all of the 
applicable requirements of this subpart; and
    (2) The prescription is otherwise in conformity with the 
requirements of the Act and this chapter.
    (f) Nothing in this part alters the responsibilities of the 
practitioner and pharmacy, specified in part 1306 of this chapter, to 
ensure the validity of a controlled substance prescription.



Sec. 1311.102  Practitioner responsibilities.

    (a) The practitioner must retain sole possession of the hard token, 
where applicable, and must not share the password or other knowledge 
factor, or biometric information, with any other person. The 
practitioner must not allow any other person to use the token or enter 
the knowledge factor or other identification means to sign prescriptions 
for controlled substances. Failure by the practitioner to secure the 
hard token, knowledge factor, or biometric information may provide a 
basis for revocation or suspension of registration pursuant to section 
304(a)(4) of the Act (21 U.S.C. 824(a)(4)).
    (b) The practitioner must notify the individuals designated under 
Sec. 1311.125 or Sec. 1311.130 within one business day of discovery 
that the hard token has been lost, stolen, or compromised or the 
authentication protocol has been otherwise compromised. A practitioner 
who fails to comply with this provision may be held responsible for any 
controlled substance prescriptions written using his two-factor 
authentication credential.
    (c) If the practitioner is notified by an intermediary or pharmacy 
that an electronic prescription was not successfully delivered, as 
provided in Sec. 1311.170, he must ensure that any paper or oral 
prescription (where permitted) issued as a replacement of the original 
electronic prescription indicates that the prescription was originally 
transmitted electronically to a particular pharmacy and that the 
transmission failed.
    (d) Before initially using an electronic prescription application to 
sign and transmit controlled substance prescriptions, the practitioner 
must determine that the third-party auditor or certification 
organization has found that the electronic prescription application 
records, stores, and transmits

[[Page 171]]

the following accurately and consistently:
    (1) The information required for a prescription under Sec. 
1306.05(a) of this chapter.
    (2) The indication of signing as required by Sec. 1311.120(b)(17) 
or the digital signature created by the practitioner's private key.
    (3) The number of refills as required by Sec. 1306.22 of this 
chapter.
    (e) If the third-party auditor or certification organization has 
found that an electronic prescription application does not accurately 
and consistently record, store, and transmit other information required 
for prescriptions under this chapter, the practitioner must not create, 
sign, and transmit electronic prescriptions for controlled substances 
that are subject to the additional information requirements.
    (f) The practitioner must not use the electronic prescription 
application to sign and transmit electronic controlled substance 
prescriptions if any of the functions of the application required by 
this subpart have been disabled or appear to be functioning improperly.
    (g) If an electronic prescription application provider notifies an 
individual practitioner that a third-party audit or certification report 
indicates that the application or the application provider no longer 
meets the requirements of this part or notifies him that the application 
provider has identified an issue that makes the application non-
compliant, the practitioner must do the following:
    (1) Immediately cease to issue electronic controlled substance 
prescriptions using the application.
    (2) Ensure, for an installed electronic prescription application at 
an individual practitioner's practice, that the individuals designated 
under Sec. 1311.125 terminate access for signing controlled substance 
prescriptions.
    (h) If an electronic prescription application provider notifies an 
institutional practitioner that a third-party audit or certification 
report indicates that the application or the application provider no 
longer meets the requirements of this part or notifies it that the 
application provider has identified an issue that makes the application 
non-compliant, the institutional practitioner must ensure that the 
individuals designated under Sec. 1311.130 terminate access for signing 
controlled substance prescriptions.
    (i) An individual practitioner or institutional practitioner that 
receives a notification that the electronic prescription application is 
not in compliance with the requirements of this part must not use the 
application to issue electronic controlled substance prescriptions until 
it is notified that the application is again compliant and all relevant 
updates to the application have been installed.
    (j) The practitioner must notify both the individuals designated 
under Sec. 1311.125 or Sec. 1311.130 and the Administration within one 
business day of discovery that one or more prescriptions that were 
issued under a DEA registration held by that practitioner were 
prescriptions the practitioner had not signed or were not consistent 
with the prescriptions he signed.
    (k) The practitioner has the same responsibilities when issuing 
prescriptions for controlled substances via electronic means as when 
issuing a paper or oral prescription. Nothing in this subpart relieves a 
practitioner of his responsibility to dispense controlled substances 
only for a legitimate medical purpose while acting in the usual course 
of his professional practice. If an agent enters information at the 
practitioner's direction prior to the practitioner reviewing and 
approving the information and signing and authorizing the transmission 
of that information, the practitioner is responsible in case the 
prescription does not conform in all essential respects to the law and 
regulations.



Sec. 1311.105  Requirements for obtaining an authentication 
credential--Individual practitioners.

    (a) An individual practitioner must obtain a two-factor 
authentication credential from one of the following:
    (1) A credential service provider that has been approved by the 
General Services Administration Office of Technology Strategy/Division 
of Identity Management to conduct identity proofing that meets the 
requirements of Assurance Level 3 or above as specified in

[[Page 172]]

NIST SP 800-63-1 as incorporated by reference in Sec. 1311.08.
    (2) For digital certificates, a certification authority that is 
cross-certified with the Federal Bridge certification authority and that 
operates at a Federal Bridge Certification Authority basic assurance 
level or above.
    (b) The practitioner must submit identity proofing information to 
the credential service provider or certification authority as specified 
by the credential service provider or certification authority.
    (c) The credential service provider or certification authority must 
issue the authentication credential using two channels (e.g., e-mail, 
mail, or telephone call). If one of the factors used in the 
authentication protocol is a biometric, or if the practitioner has a 
hard token that is being enabled to sign controlled substances 
prescriptions, the credential service provider or certification 
authority must issue two pieces of information used to generate or 
activate the authentication credential using two channels.



Sec. 1311.110  Requirements for obtaining an authentication 
credential--Individual practitioners eligible to use an electronic 

prescription application of an institutional practitioner.

    (a) For any registrant or person exempted from the requirement of 
registration under Sec. 1301.22(c) of this chapter who is eligible to 
use the institutional practitioner's electronic prescription application 
to sign prescriptions for controlled substances, the entity within a 
DEA-registered institutional practitioner that grants that individual 
practitioner privileges at the institutional practitioner (e.g., a 
hospital credentialing office) may conduct identity proofing and 
authorize the issuance of the authentication credential. That entity 
must do the following:
    (1) Ensure that photographic identification issued by the Federal 
Government or a State government matches the person presenting the 
identification.
    (2) Ensure that the individual practitioner's State authorization to 
practice and, where applicable, State authorization to prescribe 
controlled substances, is current and in good standing.
    (3) Either ensure that the individual practitioner's DEA 
registration is current and in good standing or ensure that the 
institutional practitioner has granted the individual practitioner 
exempt from the requirement of registration under Sec. 1301.22 of this 
chapter privileges to prescribe controlled substances using the 
institutional practitioner's DEA registration number.
    (4) If the individual practitioner is an employee of a health care 
facility that is operated by the Department of Veterans Affairs, confirm 
that the individual practitioner has been duly appointed to practice at 
that facility by the Secretary of the Department of Veterans Affairs 
pursuant to 38 U.S.C. 7401-7408.
    (5) If the individual practitioner is working at a health care 
facility operated by the Department of Veterans Affairs on a contractual 
basis pursuant to 38 U.S.C. 8153 and, in the performance of his duties, 
prescribes controlled substances, confirm that the individual 
practitioner meets the criteria for eligibility for appointment under 38 
U.S.C. 7401-7408 and is prescribing controlled substances under the 
registration of such facility.
    (b) An institutional practitioner that elects to conduct identity 
proofing must provide authorization to issue the authentication 
credentials to a separate entity within the institutional practitioner 
or to an outside credential Service provider or certification authority 
that meets the requirements of Sec. 1311.105(a).
    (c) When an institutional practitioner is conducting identity 
proofing and submitting information to a credential service provider or 
certification authority to authorize the issuance of authentication 
credentials, the institutional practitioner must meet any requirements 
that the credential service provider or certification authority imposes 
on entities that serve as trusted agents.
    (d) An institutional practitioner that elects to conduct identity 
proofing and authorize the issuance of the authentication credential as 
provided in paragraphs (a) through (c) of this section must do so in a 
manner consistent with the institutional practitioner's general

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obligation to maintain effective controls against diversion. Failure to 
meet this obligation may result in remedial action consistent with Sec. 
1301.36 of this chapter.
    (e) An institutional practitioner that elects to conduct identity 
proofing must retain a record of the identity-proofing. An institutional 
practitioner that elects to issue the two-factor authentication 
credential must retain a record of the issuance of the credential.



Sec. 1311.115  Additional requirements for two-factor authentication.

    (a) To sign a controlled substance prescription, the electronic 
prescription application must require the practitioner to authenticate 
to the application using an authentication protocol that uses two of the 
following three factors:
    (1) Something only the practitioner knows, such as a password or 
response to a challenge question.
    (2) Something the practitioner is, biometric data such as a 
fingerprint or iris scan.
    (3) Something the practitioner has, a device (hard token) separate 
from the computer to which the practitioner is gaining access.
    (b) If one factor is a hard token, it must be separate from the 
computer to which it is gaining access and must meet at least the 
criteria of FIPS 140-2 Security Level 1, as incorporated by reference in 
Sec. 1311.08, for cryptographic modules or one-time-password devices.
    (c) If one factor is a biometric, the biometric subsystem must 
comply with the requirements of Sec. 1311.116.



Sec. 1311.116  Additional requirements for biometrics.

    (a) If one of the factors used to authenticate to the electronic 
prescription application is a biometric as described in Sec. 1311.115, 
it must comply with the following requirements.
    (b) The biometric subsystem must operate at a false match rate of 
0.001 or lower.
    (c) The biometric subsystem must use matching software that has 
demonstrated performance at the operating point corresponding with the 
false match rate described in paragraph (b) of this section, or a lower 
false match rate. Testing to demonstrate performance must be conducted 
by the National Institute of Standards and Technology or another DEA-
approved government or nongovernment laboratory. Such testing must 
comply with the requirements of paragraph (h) of this section.
    (d) The biometric subsystem must conform to Personal Identity 
Verification authentication biometric acquisition specifications, 
pursuant to NIST SP 800-76-1 as incorporated by reference in Sec. 
1311.08, if they exist for the biometric modality of choice.
    (e) The biometric subsystem must either be co-located with a 
computer or PDA that the practitioner uses to issue electronic 
prescriptions for controlled substances, where the computer or PDA is 
located in a known, controlled location, or be built directly into the 
practitioner's computer or PDA that he uses to issue electronic 
prescriptions for controlled substances.
    (f) The biometric subsystem must store device ID data at enrollment 
(i.e., biometric registration) with the biometric data and verify the 
device ID at the time of authentication to the electronic prescription 
application.
    (g) The biometric subsystem must protect the biometric data (raw 
data or templates), match results, and/or non-match results when 
authentication is not local. If sent over an open network, biometric 
data (raw data or templates), match results, and/or non-match results 
must be:
    (1) Cryptographically source authenticated;
    (2) Combined with a random challenge, a nonce, or a time stamp to 
prevent replay;
    (3) Cryptographically protected for integrity and confidentiality; 
and
    (4) Sent only to authorized systems.
    (h) Testing of the biometric subsystem must have the following 
characteristics:
    (1) The test is conducted by a laboratory that does not have an 
interest in the outcome (positive or negative) of performance of a 
submission or biometric.
    (2) Test data are sequestered.
    (3) Algorithms are provided to the testing laboratory (as opposed to 
scores or other information).

[[Page 174]]

    (4) The operating point(s) corresponding with the false match rate 
described in paragraph (b) of this section, or a lower false match rate, 
is tested so that there is at least 95% confidence that the false match 
and non-match rates are equal to or less than the observed value.
    (5) Results of the testing are made publicly available.



Sec. 1311.120  Electronic prescription application requirements.

    (a) A practitioner may only use an electronic prescription 
application that meets the requirements in paragraph (b) of this section 
to issue electronic controlled substance prescriptions.
    (b) The electronic prescription application must meet the 
requirements of this subpart including the following:
    (1) The electronic prescription application must do the following:
    (i) Link each registrant, by name, to at least one DEA registration 
number.
    (ii) Link each practitioner exempt from registration under Sec. 
1301.22(c) of this chapter to the institutional practitioner's DEA 
registration number and the specific internal code number required under 
Sec. 1301.22(c)(5) of this chapter.
    (2) The electronic prescription application must be capable of the 
setting of logical access controls to limit permissions for the 
following functions:
    (i) Indication that a prescription is ready for signing and signing 
controlled substance prescriptions.
    (ii) Creating, updating, and executing the logical access controls 
for the functions specified in paragraph (b)(2)(i) of this section.
    (3) Logical access controls must be set by individual user name or 
role. If the application sets logical access control by role, it must 
not allow an individual to be assigned the role of registrant unless 
that individual is linked to at least one DEA registration number as 
provided in paragraph (b)(1) of this section.
    (4) The application must require that the setting and changing of 
logical access controls specified under paragraph (b)(2) of this section 
involve the actions of two individuals as specified in Sec. Sec. 
1311.125 or 1311.130. Except for institutional practitioners, a 
practitioner authorized to sign controlled substance prescriptions must 
approve logical access control entries.
    (5) The electronic prescription application must accept two-factor 
authentication that meets the requirements of Sec. 1311.115 and require 
its use for signing controlled substance prescriptions and for approving 
data that set or change logical access controls related to reviewing and 
signing controlled substance prescriptions.
    (6) The electronic prescription application must be capable of 
recording all of the applicable information required in part 1306 of 
this chapter for the controlled substance prescription.
    (7) If a practitioner has more than one DEA registration number, the 
electronic prescription application must require the practitioner or his 
agent to select the DEA registration number to be included on the 
prescription.
    (8) The electronic prescription application must have a time 
application that is within five minutes of the official National 
Institute of Standards and Technology time source.
    (9) The electronic prescription application must present for the 
practitioner's review and approval all of the following data for each 
controlled substance prescription:
    (i) The date of issuance.
    (ii) The full name of the patient.
    (iii) The drug name.
    (iv) The dosage strength and form, quantity prescribed, and 
directions for use.
    (v) The number of refills authorized, if applicable, for 
prescriptions for Schedule III, IV, and V controlled substances.
    (vi) For prescriptions written in accordance with the requirements 
of Sec. 1306.12(b) of this chapter, the earliest date on which a 
pharmacy may fill each prescription.
    (vii) The name, address, and DEA registration number of the 
prescribing practitioner.
    (viii) The statement required under Sec. 1311.140(a)(3).
    (10) The electronic prescription application must require the 
prescribing practitioner to indicate that each controlled substance 
prescription is ready for signing. The electronic prescription

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application must not permit alteration of the DEA elements after the 
practitioner has indicated that a controlled substance prescription is 
ready to be signed without requiring another review and indication of 
readiness for signing. Any controlled substance prescription not 
indicated as ready to be signed shall not be signed or transmitted.
    (11) While the information required by paragraph (b)(9) of this 
section and the statement required by Sec. 1311.140(a)(3) remain 
displayed, the electronic prescription application must prompt the 
prescribing practitioner to authenticate to the application, using two-
factor authentication, as specified in Sec. 1311.140(a)(4), which will 
constitute the signing of the prescription by the practitioner for 
purposes of Sec. 1306.05(a) and (e) of this chapter.
    (12) The electronic prescription application must not permit a 
practitioner other than the prescribing practitioner whose DEA number 
(or institutional practitioner DEA number and extension data for the 
individual practitioner) is listed on the prescription as the 
prescribing practitioner and who has indicated that the prescription is 
ready to be signed to sign the prescription.
    (13) Where a practitioner seeks to prescribe more than one 
controlled substance at one time for a particular patient, the 
electronic prescription application may allow the practitioner to sign 
multiple prescriptions for a single patient at one time using a single 
invocation of the two-factor authentication protocol provided the 
following has occurred: The practitioner has individually indicated that 
each controlled substance prescription is ready to be signed while the 
information required by paragraph (b)(9) of this section for each such 
prescription is displayed along with the statement required by Sec. 
1311.140(a)(3).
    (14) The electronic prescription application must time and date 
stamp the prescription when the signing function is used.
    (15) When the practitioner uses his two-factor authentication 
credential as specified in Sec. 1311.140(a)(4), the electronic 
prescription application must digitally sign at least the information 
required by part 1306 of this chapter and electronically archive the 
digitally signed record. If the practitioner signs the prescription with 
his own private key, as provided in Sec. 1311.145, the electronic 
prescription application must electronically archive a copy of the 
digitally signed record, but need not apply the application's digital 
signature to the record.
    (16) The digital signature functionality must meet the following 
requirements:
    (i) The cryptographic module used to digitally sign the data 
elements required by part 1306 of this chapter must be at least FIPS 
140-2 Security Level 1 validated. FIPS 140-2 is incorporated by 
reference in Sec. 1311.08.
    (ii) The digital signature application and hash function must comply 
with FIPS 186-3 and FIPS 180-3, as incorporated by reference in Sec. 
1311.08.
    (iii) The electronic prescription application's private key must be 
stored encrypted on a FIPS 140-2 Security Level 1 or higher validated 
cryptographic module using a FIPS-approved encryption algorithm. FIPS 
140-2 is incorporated by reference in Sec. 1311.08.
    (iv) For software implementations, when the signing module is 
deactivated, the application must clear the plain text password from the 
application memory to prevent the unauthorized access to, or use of, the 
private key.
    (17) Unless the digital signature created by an individual 
practitioner's private key is being transmitted to the pharmacy with the 
prescription, the electronic prescription application must include in 
the data file transmitted an indication that the prescription was signed 
by the prescribing practitioner.
    (18) The electronic prescription application must not transmit a 
controlled substance prescription unless the signing function described 
in Sec. 1311.140(a)(4) has been used.
    (19) The electronic prescription application must not allow 
alteration of any of the information required by part 1306 of this 
chapter after the prescription has been digitally signed. Any alteration 
of the information required by

[[Page 176]]

part 1306 of this chapter after the prescription is digitally signed 
must cancel the prescription.
    (20) The electronic prescription application must not allow 
transmission of a prescription that has been printed.
    (21) The electronic prescription application must allow printing of 
a prescription after transmission only if the printed prescription is 
clearly labeled as a copy not for dispensing. The electronic 
prescription application may allow printing of prescription information 
if clearly labeled as being for informational purposes. The electronic 
prescription application may transfer such prescription information to 
medical records.
    (22) If the transmission of an electronic prescription fails, the 
electronic prescription application may print the prescription. The 
prescription must indicate that it was originally transmitted 
electronically to, and provide the name of, a specific pharmacy, the 
date and time of transmission, and that the electronic transmission 
failed.
    (23) The electronic prescription application must maintain an audit 
trail of all actions related to the following:
    (i) The creation, alteration, indication of readiness for signing, 
signing, transmission, or deletion of a controlled substance 
prescription.
    (ii) Any setting or changing of logical access control permissions 
related to the issuance of controlled substance prescriptions.
    (iii) Notification of a failed transmission.
    (iv) Auditable events as specified in Sec. 1311.150.
    (24) The electronic prescription application must record within each 
audit record the following information:
    (i) The date and time of the event.
    (ii) The type of event.
    (iii) The identity of the person taking the action, where 
applicable.
    (iv) The outcome of the event (success or failure).
    (25) The electronic prescription application must conduct internal 
audits and generate reports on any of the events specified in Sec. 
1311.150 in a format that is readable by the practitioner. Such internal 
audits may be automated and need not require human intervention to be 
conducted.
    (26) The electronic prescription application must protect the stored 
audit records from unauthorized deletion. The electronic prescription 
application shall prevent modifications to the audit records.
    (27) The electronic prescription application must do the following:
    (i) Generate a log of all controlled substance prescriptions issued 
by a practitioner during the previous calendar month and provide the log 
to the practitioner no later than seven calendar days after that month.
    (ii) Be capable of generating a log of all controlled substance 
prescriptions issued by a practitioner for a period specified by the 
practitioner upon request. Prescription information available from which 
to generate the log must span at least the previous two years.
    (iii) Archive all logs generated.
    (iv) Ensure that all logs are easily readable or easily rendered 
into a format that a person can read.
    (v) Ensure that all logs are sortable by patient name, drug name, 
and date of issuance of the prescription.
    (28) Where the electronic prescription application is required by 
this part to archive or otherwise maintain records, it must retain such 
records electronically for two years from the date of the record's 
creation and comply with all other requirements of Sec. 1311.305.



Sec. 1311.125  Requirements for establishing logical access 
control--Individual practitioner.

    (a) At each registered location where one or more individual 
practitioners wish to use an electronic prescription application meeting 
the requirements of this subpart to issue controlled substance 
prescriptions, the registrant(s) must designate at least two individuals 
to manage access control to the application. At least one of the 
designated individuals must be a registrant who is authorized to issue 
controlled substance prescriptions and who has obtained a two-factor 
authentication credential as provided in Sec. 1311.105.
    (b) At least one of the individuals designated under paragraph (a) 
of this section must verify that the DEA registration and State 
authorization(s) to practice and, where applicable, State

[[Page 177]]

authorization(s) to dispense controlled substances of each registrant 
being granted permission to sign electronic prescriptions for controlled 
substances are current and in good standing.
    (c) After one individual designated under paragraph (a) of this 
section enters data that grants permission for individual practitioners 
to have access to the prescription functions that indicate readiness for 
signature and signing or revokes such authorization, a second individual 
designated under paragraph (a) of this section must use his two-factor 
authentication credential to satisfy the logical access controls. The 
second individual must be a DEA registrant.
    (d) A registrant's permission to indicate that controlled substances 
prescriptions are ready to be signed and to sign controlled substance 
prescriptions must be revoked whenever any of the following occurs, on 
the date the occurrence is discovered:
    (1) A hard token or any other authentication factor required by the 
two-factor authentication protocol is lost, stolen, or compromised. Such 
access must be terminated immediately upon receiving notification from 
the individual practitioner.
    (2) The individual practitioner's DEA registration expires, unless 
the registration has been renewed.
    (3) The individual practitioner's DEA registration is terminated, 
revoked, or suspended.
    (4) The individual practitioner is no longer authorized to use the 
electronic prescription application (e.g., when the individual 
practitioner leaves the practice).



Sec. 1311.130  Requirements for establishing logical access 
control--Institutional practitioner.

    (a) The entity within an institutional practitioner that conducts 
the identity proofing under Sec. 1311.110 must develop a list of 
individual practitioners who are permitted to use the institutional 
practitioner's electronic prescription application to indicate that 
controlled substances prescriptions are ready to be signed and to sign 
controlled substance prescriptions. The list must be approved by two 
individuals.
    (b) After the list is approved, it must be sent to a separate entity 
within the institutional practitioner that enters permissions for 
logical access controls into the application. The institutional 
practitioner must authorize at least two individuals or a role filled by 
at least two individuals to enter the logical access control data. One 
individual in the separate entity must authenticate to the application 
and enter the data to grant permissions to individual practitioners to 
indicate that controlled substances prescriptions are ready to be signed 
and to sign controlled substance prescriptions. A second individual must 
authenticate to the application to execute the logical access controls.
    (c) The institutional practitioner must retain a record of the 
individuals or roles that are authorized to conduct identity proofing 
and logical access control data entry and execution.
    (d) Permission to indicate that controlled substances prescriptions 
are ready to be signed and to sign controlled substance prescriptions 
must be revoked whenever any of the following occurs, on the date the 
occurrence is discovered:
    (1) An individual practitioner's hard token or any other 
authentication factor required by the practitioner's two-factor 
authentication protocol is lost, stolen, or compromised. Such access 
must be terminated immediately upon receiving notification from the 
individual practitioner.
    (2) The institutional practitioner's or, where applicable, 
individual practitioner's DEA registration expires, unless the 
registration has been renewed.
    (3) The institutional practitioner's or, where applicable, 
individual practitioner's DEA registration is terminated, revoked, or 
suspended.
    (4) An individual practitioner is no longer authorized to use the 
institutional practitioner's electronic prescription application (e.g., 
when the individual practitioner is no longer associated with the 
institutional practitioner.)



Sec. 1311.135  Requirements for creating a controlled substance 
prescription.

    (a) The electronic prescription application may allow the registrant 
or his

[[Page 178]]

agent to enter data for a controlled substance prescription, provided 
that only the registrant may sign the prescription in accordance with 
Sec. Sec. 1311.120(b)(11) and 1311.140.
    (b) If a practitioner holds multiple DEA registrations, the 
practitioner or his agent must select the appropriate registration 
number for the prescription being issued in accordance with the 
requirements of Sec. 1301.12 of this chapter.
    (c) If required by State law, a supervisor's name and DEA number may 
be listed on a prescription, provided the prescription clearly indicates 
who is the supervisor and who is the prescribing practitioner.



Sec. 1311.140  Requirements for signing a controlled substance prescription.

    (a) For a practitioner to sign an electronic prescription for a 
controlled substance the following must occur:
    (1) The practitioner must access a list of one or more controlled 
substance prescriptions for a single patient. The list must display the 
information required by Sec. 1311.120(b)(9).
    (2) The practitioner must indicate the prescriptions that are ready 
to be signed.
    (3) While the prescription information required in Sec. 
1311.120(b)(9) is displayed, the following statement or its substantial 
equivalent is displayed: ``By completing the two-factor authentication 
protocol at this time, you are legally signing the prescription(s) and 
authorizing the transmission of the above information to the pharmacy 
for dispensing. The two-factor authentication protocol may only be 
completed by the practitioner whose name and DEA registration number 
appear above.''
    (4) While the prescription information required in Sec. 
1311.120(b)(9) and the statement required by paragraph (a)(3) of this 
section remain displayed, the practitioner must be prompted to complete 
the two-factor authentication protocol.
    (5) The completion by the practitioner of the two-factor 
authentication protocol in the manner provided in paragraph (a)(4) of 
this section will constitute the signing of the prescription by the 
practitioner for purposes of Sec. 1306.05(a) and (e) of this chapter.
    (6) Except as provided under Sec. 1311.145, the practitioner's 
completion of the two-factor authentication protocol must cause the 
application to digitally sign and electronically archive the information 
required under part 1306 of this chapter.
    (b) The electronic prescription application must clearly label as 
the signing function the function that prompts the practitioner to 
execute the two-factor authentication protocol using his credential.
    (c) Any prescription not signed in the manner required by this 
section shall not be transmitted.



Sec. 1311.145  Digitally signing the prescription with the individual
practitioner's private key.

    (a) An individual practitioner who has obtained a digital 
certificate as provided in Sec. 1311.105 may digitally sign a 
controlled substance prescription using the private key associated with 
his digital certificate.
    (b) The electronic prescription application must require the 
individual practitioner to complete a two-factor authentication protocol 
as specified in Sec. 1311.140(a)(4) to use his private key.
    (c) The electronic prescription application must digitally sign at 
least all information required under part 1306 of this chapter.
    (d) The electronic prescription application must electronically 
archive the digitally signed record.
    (e) A prescription that is digitally signed with a practitioner's 
private key may be transmitted to a pharmacy without the digital 
signature.
    (f) If the electronic prescription is transmitted without the 
digital signature, the electronic prescription application must check 
the certificate revocation list of the certification authority that 
issued the practitioner's digital certificate. If the digital 
certificate is not valid, the electronic prescription application must 
not transmit the prescription. The certificate revocation list may be 
cached until the certification authority issues a new certificate 
revocation list.
    (g) When the individual practitioner digitally signs a controlled 
substance

[[Page 179]]

prescription with the private key associated with his own digital 
certificate obtained as provided under Sec. 1311.105, the electronic 
prescription application is not required to digitally sign the 
prescription using the application's private key.



Sec. 1311.150  Additional requirements for internal application audits.

    (a) The application provider must establish and implement a list of 
auditable events. Auditable events must, at a minimum, include the 
following:
    (1) Attempted unauthorized access to the electronic prescription 
application, or successful unauthorized access where the determination 
of such is feasible.
    (2) Attempted unauthorized modification or destruction of any 
information or records required by this part, or successful unauthorized 
modification or destruction of any information or records required by 
this part where the determination of such is feasible.
    (3) Interference with application operations of the prescription 
application.
    (4) Any setting of or change to logical access controls related to 
the issuance of controlled substance prescriptions.
    (5) Attempted or successful interference with audit trail functions.
    (6) For application service providers, attempted or successful 
creation, modification, or destruction of controlled substance 
prescriptions or logical access controls related to controlled substance 
prescriptions by any agent or employee of the application service 
provider.
    (b) The electronic prescription application must analyze the audit 
trail at least once every calendar day and generate an incident report 
that identifies each auditable event.
    (c) Any person designated to set logical access controls under 
Sec. Sec. 1311.125 or 1311.130 must determine whether any identified 
auditable event represents a security incident that compromised or could 
have compromised the integrity of the prescription records. Any such 
incidents must be reported to the electronic prescription application 
provider and the Administration within one business day.



Sec. 1311.170  Transmission requirements.

    (a) The electronic prescription application must transmit the 
electronic prescription as soon as possible after signature by the 
practitioner.
    (b) The electronic prescription application may print a prescription 
that has been transmitted only if an intermediary or the designated 
pharmacy notifies a practitioner that an electronic prescription was not 
successfully delivered to the designated pharmacy. If this occurs, the 
electronic prescription application may print the prescription for the 
practitioner's manual signature. The printed prescription must include 
information noting that the prescription was originally transmitted 
electronically to [name of the specific pharmacy] on [date/time] and 
that transmission failed.
    (c) The electronic prescription application may print copies of the 
transmitted prescription if they are clearly labeled: ``Copy only--not 
valid for dispensing.'' Data on the prescription may be electronically 
transferred to medical records, and a list of prescriptions written may 
be printed for patients if the list indicates that it is for 
informational purposes only and not for dispensing.
    (d) The electronic prescription application must not allow the 
transmission of an electronic prescription if an original prescription 
was printed prior to attempted transmission.
    (e) The contents of the prescription required by part 1306 of this 
chapter must not be altered during transmission between the practitioner 
and pharmacy. Any change to the content during transmission, including 
truncation or removal of data, will render the electronic prescription 
invalid. The electronic prescription data may be converted from one 
software version to another between the electronic prescription 
application and the pharmacy application; conversion includes altering 
the structure of fields or machine language so that the receiving 
pharmacy application can read the prescription and import the data.
    (f) An electronic prescription must be transmitted from the 
practitioner to

[[Page 180]]

the pharmacy in its electronic form. At no time may an intermediary 
convert an electronic prescription to another form (e.g., facsimile) for 
transmission.



Sec. 1311.200  Pharmacy responsibilities.

    (a) Before initially using a pharmacy application to process 
controlled substance prescriptions, the pharmacy must determine that the 
third-party auditor or certification organization has found that the 
pharmacy application does the following accurately and consistently:
    (1) Import, store, and display the information required for 
prescriptions under Sec. 1306.05(a) of this chapter.
    (2) Import, store, and display the indication of signing as required 
by Sec. 1311.120(b)(17).
    (3) Import, store, and display the number of refills as required by 
Sec. 1306.22 of this chapter.
    (4) Import, store, and verify the practitioner's digital signature, 
as provided in Sec. 1311.210(c), where applicable.
    (b) If the third-party auditor or certification organization has 
found that a pharmacy application does not accurately and consistently 
import, store, and display other information required for prescriptions 
under this chapter, the pharmacy must not process electronic 
prescriptions for controlled substances that are subject to the 
additional information requirements.
    (c) If a pharmacy application provider notifies a pharmacy that a 
third-party audit or certification report indicates that the application 
or the application provider no longer meets the requirements of this 
part or notifies it that the application provider has identified an 
issue that makes the application non-compliant, the pharmacy must 
immediately cease to process controlled substance prescriptions using 
the application.
    (d) A pharmacy that receives a notification that the pharmacy 
application is not in compliance with the requirements of this part must 
not use the application to process controlled substance prescriptions 
until it is notified that the application is again compliant and all 
relevant updates to the application have been installed.
    (e) The pharmacy must determine which employees are authorized to 
enter information regarding the dispensing of controlled substance 
prescriptions and annotate or alter records of these prescriptions (to 
the extent such alterations are permitted under this chapter). The 
pharmacy must ensure that logical access controls in the pharmacy 
application are set so that only such employees are granted access to 
perform these functions.
    (f) When a pharmacist fills a prescription in a manner that would 
require, under part 1306 of this chapter, the pharmacist to make a 
notation on the prescription if the prescription were a paper 
prescription, the pharmacist must make the same notation electronically 
when filling an electronic prescription and retain the annotation 
electronically in the prescription record or in linked files. When a 
prescription is received electronically, the prescription and all 
required annotations must be retained electronically.
    (g) When a pharmacist receives a paper or oral prescription that 
indicates that it was originally transmitted electronically to the 
pharmacy, the pharmacist must check its records to ensure that the 
electronic version was not received and the prescription dispensed. If 
both prescriptions were received, the pharmacist must mark one as void.
    (h) When a pharmacist receives a paper or oral prescription that 
indicates that it was originally transmitted electronically to another 
pharmacy, the pharmacist must check with that pharmacy to determine 
whether the prescription was received and dispensed. If the pharmacy 
that received the original electronic prescription had not dispensed the 
prescription, that pharmacy must mark the electronic version as void or 
canceled. If the pharmacy that received the original electronic 
prescription dispensed the prescription, the pharmacy with the paper 
version must not dispense the paper prescription and must mark the 
prescription as void.
    (i) Nothing in this part relieves a pharmacy and pharmacist of the 
responsibility to dispense controlled substances only pursuant to a 
prescription issued for a legitimate medical purpose

[[Page 181]]

by a practitioner acting in the usual course of professional practice.



Sec. 1311.205  Pharmacy application requirements.

    (a) The pharmacy may only use a pharmacy application that meets the 
requirements in paragraph (b) of this section to process electronic 
controlled substance prescriptions.
    (b) The pharmacy application must meet the following requirements:
    (1) The pharmacy application must be capable of setting logical 
access controls to limit access for the following functions:
    (i) Annotation, alteration, or deletion of prescription information.
    (ii) Setting and changing the logical access controls.
    (2) Logical access controls must be set by individual user name or 
role.
    (3) The pharmacy application must digitally sign and archive a 
prescription on receipt or be capable of receiving and archiving a 
digitally signed record.
    (4) For pharmacy applications that digitally sign prescription 
records upon receipt, the digital signature functionality must meet the 
following requirements:
    (i) The cryptographic module used to digitally sign the data 
elements required by part 1306 of this chapter must be at least FIPS 
140-2 Security Level 1 validated. FIPS 140-2 is incorporated by 
reference in Sec. 1311.08.
    (ii) The digital signature application and hash function must comply 
with FIPS 186-3 and FIPS 180-3, as incorporated by reference in Sec. 
1311.08.
    (iii) The pharmacy application's private key must be stored 
encrypted on a FIPS 140-2 Security Level 1 or higher validated 
cryptographic module using a FIPS-approved encryption algorithm. FIPS 
140-2 is incorporated by reference in Sec. 1311.08.
    (iv) For software implementations, when the signing module is 
deactivated, the pharmacy application must clear the plain text password 
from the application memory to prevent the unauthorized access to, or 
use of, the private key.
    (v) The pharmacy application must have a time application that is 
within five minutes of the official National Institute of Standards and 
Technology time source.
    (5) The pharmacy application must verify a practitioner's digital 
signature (if the pharmacy application accepts prescriptions that were 
digitally signed with an individual practitioner's private key and 
transmitted with the digital signature).
    (6) If the prescription received by the pharmacy application has not 
been digitally signed by the practitioner and transmitted with the 
digital signature, the pharmacy application must either:
    (i) Verify that the practitioner signed the prescription by checking 
the data field that indicates the prescription was signed; or
    (ii) Display the field for the pharmacist's verification.
    (7) The pharmacy application must read and retain the full DEA 
number including the specific internal code number assigned to 
individual practitioners authorized to prescribe controlled substances 
by the hospital or other institution as provided in Sec. 1301.22(c) of 
this chapter.
    (8) The pharmacy application must read and store, and be capable of 
displaying, all information required by part 1306 of this chapter.
    (9) The pharmacy application must read and store in full the 
information required under Sec. 1306.05(a) of this chapter. The 
pharmacy application must either verify that such information is present 
or must display the information for the pharmacist's verification.
    (10) The pharmacy application must provide for the following 
information to be added or linked to each electronic controlled 
substance prescription record for each dispensing:
    (i) Number of units or volume of drug dispensed.
    (ii) Date dispensed.
    (iii) Name or initials of the person who dispensed the prescription.
    (11) The pharmacy application must be capable of retrieving 
controlled substance prescriptions by practitioner name, patient name, 
drug name, and date dispensed.
    (12) The pharmacy application must allow downloading of prescription 
data into a database or spreadsheet that is readable and sortable.

[[Page 182]]

    (13) The pharmacy application must maintain an audit trail of all 
actions related to the following:
    (i) The receipt, annotation, alteration, or deletion of a controlled 
substance prescription.
    (ii) Any setting or changing of logical access control permissions 
related to the dispensing of controlled substance prescriptions.
    (iii) Auditable events as specified in Sec. 1311.215.
    (14) The pharmacy application must record within each audit record 
the following information:
    (i) The date and time of the event.
    (ii) The type of event.
    (iii) The identity of the person taking the action, where 
applicable.
    (iv) The outcome of the event (success or failure).
    (15) The pharmacy application must conduct internal audits and 
generate reports on any of the events specified in Sec. 1311.215 in a 
format that is readable by the pharmacist. Such an internal audit may be 
automated and need not require human intervention to be conducted.
    (16) The pharmacy application must protect the stored audit records 
from unauthorized deletion. The pharmacy application shall prevent 
modifications to the audit records.
    (17) The pharmacy application must back up the controlled substance 
prescription records daily.
    (18) The pharmacy application must retain all archived records 
electronically for at least two years from the date of their receipt or 
creation and comply with all other requirements of Sec. 1311.305.



Sec. 1311.210  Archiving the initial record.

    (a) Except as provided in paragraph (c) of this section, a copy of 
each electronic controlled substance prescription record that a pharmacy 
receives must be digitally signed by one of the following:
    (1) The last intermediary transmitting the record to the pharmacy 
must digitally sign the prescription immediately prior to transmission 
to the pharmacy.
    (2) The first pharmacy application that receives the electronic 
prescription must digitally sign the prescription immediately on 
receipt.
    (b) If the last intermediary digitally signs the record, it must 
forward the digitally signed copy to the pharmacy.
    (c) If a pharmacy receives a digitally signed prescription that 
includes the individual practitioner's digital signature, the pharmacy 
application must do the following:
    (1) Verify the digital signature as provided in FIPS 186-3, as 
incorporated by reference in Sec. 1311.08.
    (2) Check the validity of the certificate holder's digital 
certificate by checking the certificate revocation list. The pharmacy 
may cache the CRL until it expires.
    (3) Archive the digitally signed record. The pharmacy record must 
retain an indication that the prescription was verified upon receipt. No 
additional digital signature is required.



Sec. 1311.215  Internal audit trail.

    (a) The pharmacy application provider must establish and implement a 
list of auditable events. The auditable events must, at a minimum, 
include the following:
    (1) Attempted unauthorized access to the pharmacy application, or 
successful unauthorized access to the pharmacy application where the 
determination of such is feasible.
    (2) Attempted or successful unauthorized modification or destruction 
of any information or records required by this part, or successful 
unauthorized modification or destruction of any information or records 
required by this part where the determination of such is feasible.
    (3) Interference with application operations of the pharmacy 
application.
    (4) Any setting of or change to logical access controls related to 
the dispensing of controlled substance prescriptions.
    (5) Attempted or successful interference with audit trail functions.
    (6) For application service providers, attempted or successful 
annotation, alteration, or destruction of controlled substance 
prescriptions or logical access controls related to controlled substance 
prescriptions by any agent or employee of the application service 
provider.

[[Page 183]]

    (b) The pharmacy application must analyze the audit trail at least 
once every calendar day and generate an incident report that identifies 
each auditable event.
    (c) The pharmacy must determine whether any identified auditable 
event represents a security incident that compromised or could have 
compromised the integrity of the prescription records. Any such 
incidents must be reported to the pharmacy application service provider, 
if applicable, and the Administration within one business day.



Sec. 1311.300  Application provider requirements--Third-party audits
or certifications.

    (a) Except as provided in paragraph (e) of this section, the 
application provider of an electronic prescription application or a 
pharmacy application must have a third-party audit of the application 
that determines that the application meets the requirements of this part 
at each of the following times:
    (1) Before the application may be used to create, sign, transmit, or 
process controlled substance prescriptions.
    (2) Whenever a functionality related to controlled substance 
prescription requirements is altered or every two years, whichever 
occurs first.
    (b) The third-party audit must be conducted by one of the following:
    (1) A person qualified to conduct a SysTrust, WebTrust, or SAS 70 
audit.
    (2) A Certified Information System Auditor who performs compliance 
audits as a regular ongoing business activity.
    (c) An audit for installed applications must address processing 
integrity and determine that the application meets the requirements of 
this part.
    (d) An audit for application service providers must address 
processing integrity and physical security and determine that the 
application meets the requirements of this part.
    (e) If a certifying organization whose certification process has 
been approved by DEA verifies and certifies that an electronic 
prescription or pharmacy application meets the requirements of this 
part, certification by that organization may be used as an alternative 
to the audit requirements of paragraphs (b) through (d) of this section, 
provided that the certification that determines that the application 
meets the requirements of this part occurs at each of the following 
times:
    (1) Before the application may be used to create, sign, transmit, or 
process controlled substance prescriptions.
    (2) Whenever a functionality related to controlled substance 
prescription requirements is altered or every two years, whichever 
occurs first.
    (f) The application provider must make the audit or certification 
report available to any practitioner or pharmacy that uses the 
application or is considering use of the application. The electronic 
prescription or pharmacy application provider must retain the most 
recent audit or certification results and retain the results of any 
other audits or certifications of the application completed within the 
previous two years.
    (g) Except as provided in paragraphs (h) and (i) of this section, if 
the third-party auditor or certification organization finds that the 
application does not meet one or more of the requirements of this part, 
the application must not be used to create, sign, transmit, or process 
electronic controlled substance prescriptions. The application provider 
must notify registrants within five business days of the issuance of the 
audit or certification report that they should not use the application 
for controlled substance prescriptions. The application provider must 
also notify the Administration of the adverse audit or certification 
report and provide the report to the Administration within one business 
day of issuance.
    (h) For electronic prescription applications, the third-party 
auditor or certification organization must make the following 
determinations:
    (1) If the information required in Sec. 1306.05(a) of this chapter, 
the indication that the prescription was signed as required by Sec. 
1311.120(b)(17) or the digital signature created by the practitioner's 
private key, if transmitted, and the number of refills as required by 
Sec. 1306.22 of this chapter, cannot be consistently and accurately 
recorded, stored, and transmitted, the third-

[[Page 184]]

party auditor or certification organization must indicate that the 
application does not meet the requirements of this part.
    (2) If other information required under this chapter cannot be 
consistently and accurately recorded, stored, and transmitted, the 
third-party auditor or certification organization must indicate that the 
application has failed to meet the requirements for the specific 
information and should not be used to create, sign, and transmit 
prescriptions that require the additional information.
    (i) For pharmacy applications, the third-party auditor or 
certification organization must make the following determinations:
    (1) If the information required in Sec. 1306.05(a) of this chapter, 
the indication that the prescription was signed as required by Sec. 
1311.205(b)(6), and the number of refills as required by Sec. 1306.22 
of this chapter, cannot be consistently and accurately imported, stored, 
and displayed, the third-party auditor or certification organization 
must indicate that the application does not meet the requirements of 
this part.
    (2) If the pharmacy application accepts prescriptions with the 
practitioner's digital signature, the third-party auditor or 
certification organization must indicate that the application does not 
meet the requirements of this part if the application does not 
consistently and accurately import, store, and verify the digital 
signature.
    (3) If other information required under this chapter cannot be 
consistently and accurately imported, stored, and displayed, the third-
party auditor or certification organization must indicate that the 
application has failed to meet the requirements for the specific 
information and should not be used to process electronic prescriptions 
that require the additional information.



Sec. 1311.302  Additional application provider requirements.

    (a) If an application provider identifies or is made aware of any 
issue with its application that make the application non-compliant with 
the requirements of this part, the application provider must notify 
practitioners or pharmacies that use the application as soon as 
feasible, but no later than five business days after discovery, that the 
application should not be used to issue or process electronic controlled 
substance prescriptions.
    (b) When providing practitioners or pharmacies with updates to any 
issue that makes the application non-compliant with the requirements of 
this part, the application provider must indicate that the updates must 
be installed before the practitioner or pharmacy may use the application 
to issue or process electronic controlled substance prescriptions.



Sec. 1311.305  Recordkeeping.

    (a) If a prescription is created, signed, transmitted, and received 
electronically, all records related to that prescription must be 
retained electronically.
    (b) Records required by this subpart must be maintained 
electronically for two years from the date of their creation or receipt. 
This record retention requirement shall not pre-empt any longer period 
of retention which may be required now or in the future, by any other 
Federal or State law or regulation, applicable to practitioners, 
pharmacists, or pharmacies.
    (c) Records regarding controlled substances prescriptions must be 
readily retrievable from all other records. Electronic records must be 
easily readable or easily rendered into a format that a person can read.
    (d) Records required by this part must be made available to the 
Administration upon request.
    (e) If an application service provider ceases to provide an 
electronic prescription application or an electronic pharmacy 
application or if a registrant ceases to use an application service 
provider, the application service provider must transfer any records 
subject to this part to the registrant in a format that the registrant's 
applications are capable of retrieving, displaying, and printing in a 
readable format.
    (f) If a registrant changes application providers, the registrant 
must ensure that any records subject to this part are migrated to the 
new application or are stored in a format that can be retrieved, 
displayed, and printed in a readable format.

[[Page 185]]

    (g) If a registrant transfers its electronic prescription files to 
another registrant, both registrants must ensure that the records are 
migrated to the new application or are stored in a format that can be 
retrieved, displayed, and printed in a readable format.
    (h) Digitally signed prescription records must be transferred or 
migrated with the digital signature.



PART 1312_IMPORTATION AND EXPORTATION OF CONTROLLED SUBSTANCES--Table
of Contents



Sec.
1312.01 Scope of part 1312.
1312.02 Definitions.

                  Importation of Controlled Substances

1312.11 Requirement of authorization to import.
1312.12 Application for import permit.
1312.13 Issuance of import permit.
1312.14 Distribution of copies of import permit.
1312.15 Shipments in greater or less amount than authorized.
1312.16 Cancellation of permit; expiration date.
1312.17 Special report from importers.
1312.18 Contents of import declaration.
1312.19 Distribution of import declaration.

                  Exportation of Controlled Substances

1312.21 Requirement of authorization to export.
1312.22 Application for export permit.
1312.23 Issuance of export permit.
1312.24 Distribution of copies of export permit.
1312.25 Expiration date.
1312.26 Records required of exporter.
1312.27 Contents of special controlled substances invoice.
1312.28 Distribution of special controlled substances invoice.
1312.29 Domestic release prohibited.
1312.30 Schedule III, IV, and V non-narcotic controlled substances 
          requiring an import and export permit.

     Transshipment and In-Transit Shipment of Controlled Substances

1312.31 Schedule I: Application for prior written approval.
1312.32 Schedules II, III, IV: Advance notice.

                                Hearings

1312.41 Hearings generally.
1312.42 Purpose of hearing.
1312.43 Waiver or modification of rules.
1312.44 Request for hearing or appearance; waiver.
1312.45 Burden of proof.
1312.46 Time and place of hearing.
1312.47 Final order.

    Authority: 21 U.S.C. 952, 953, 954, 957, 958.

    Source: 36 FR 7815, Apr. 24, 1971, unless otherwise noted. 
Redesignated at 38 FR 26609, Sept. 24, 1973.



Sec. 1312.01  Scope of part 1312.

    Procedures governing the importation, exportation, transshipment and 
intransit shipment of controlled substances pursuant to section 1002, 
1003, and 1004 of the Act (21 U.S.C. 952, 953, and 954) are governed 
generally by those sections and specifically by the sections of this 
part.



Sec. 1312.02  Definitions.

    Any term contained in this part shall have the definition set forth 
in section 102 of the Act (21 U.S.C. 802) or part 1300 of this chapter.

[62 FR 13969, Mar. 24, 1997]

                  Importation of Controlled Substances



Sec. 1312.11  Requirement of authorization to import.

    (a) No person shall import or cause to be imported any controlled 
substance listed in Schedule I or II or any narcotic controlled 
substance listed in Schedule III, IV or V or any non-narcotic controlled 
substance in Schedule III which the Administrator has specifically 
designated by regulation in Sec. 1312.30 of this part or any non-
narcotic controlled substance in Schedule IV or V which is also listed 
in Schedule I or II of the Convention on Psychotropic Substances unless 
and until such person is properly registered under the Act (or exempt 
from registration) and the Administrator has issued him a permit to do 
so pursuant to Sec. 1312.13 of this part.
    (b) No person shall import or cause to be imported any non-narcotic 
controlled substance listed in Schedule III, IV or V, excluding those 
described in paragraph (a) of this section, unless and until such person 
is properly registered under the Act (or exempt from registration) and 
has filed an import declaration to do so with the Administrator, 
pursuant to Sec. 1312.18 of this part.

[[Page 186]]

    (c) When an import permit or declaration is required, a separate 
permit or declaration must be obtained for each consignment of 
controlled substances to be imported.

[36 FR 7815, Apr. 24, 1971, as amended at 37 FR 15923, Aug. 8, 1972. 
Redesignated at 38 FR 26609, Sept. 24, 1973, and amended at 52 FR 17289, 
May 7, 1987]



Sec. 1312.12  Application for import permit.

    (a) An application for a permit to import controlled substances 
shall be made on DEA Form 357. DEA Form 357 may be obtained from, and 
shall be filed with, the Import/Export Unit, Drug Enforcement 
Administration. See the Table of DEA Mailing Addresses in Sec. 1321.01 
of this chapter for the current mailing address. Each application shall 
show the date of execution; the registration number of the importer; a 
detailed description of each controlled substance to be imported 
including the drug name, dosage form, National Drug Code (NDC) number, 
the Administration Controlled Substance Code Number as set forth in part 
1308 of this chapter, the number and size of packages or containers, the 
name and quantity of the controlled substance contained in any finished 
dosage units, and the net quantity of any controlled substance 
(expressed in anhydrous acid, base or alkaloid) given in kilograms or 
parts thereof. The application shall also include the following:
    (1) The name, address, and business of the consignor, if known at 
the time application is submitted, but if unknown at that time, the fact 
should be indicated and the name and address afterwards furnished to the 
Administrator as soon as ascertained by the importer;
    (2) The foreign port of exportation (i.e., the place where the 
article will begin its journey of exportation to the United States);
    (3) The port of entry into the United States;
    (4) The latest date said shipment will leave said foreign port;
    (5) The stock on hand of the controlled substance desired to be 
imported;
    (6) The name of the importing carrier or vessel (if known, or if 
unknown it should be stated whether shipment will be made by express, 
freight, or otherwise, imports of controlled substances in Schedules I 
or II and narcotic drugs in Schedules III, IV, or V by mail being 
prohibited);
    (7) The total tentative allotment to the importer of such controlled 
substance for the current calendar year;
    (8) The total number of kilograms of said allotment for which 
permits have previously been issued and the total quantity of controlled 
substance actually imported during the current year to date.
    (b) If desired, alternative foreign ports of exportation within the 
same country may be indicated upon the application (e.g., (1) Calcutta, 
(2) Bombay). If a formal permit is issued pursuant to such application, 
it will bear the names of the two ports in the order given in the 
application and will authorize shipment from either port. Alternate 
ports in different countries will not be authorized in the same permit.

[36 FR 7815, Apr. 24, 1971, as amended at 36 FR 13387, July 21, 1971. 
Redesignated at 38 FR 26609, Sept. 24, 1973, and amended at 39 FR 43218, 
Dec. 11, 1974; 45 FR 74715, Nov. 12, 1980; 51 FR 5319, 5320, Feb. 13, 
1986; 52 FR 17289, May 7, 1987; 62 FR 13969, Mar. 24, 1997; 75 FR 10681, 
Mar. 9, 2010]



Sec. 1312.13  Issuance of import permit.

    (a) The Administrator may authorize importation of any controlled 
substance listed in Schedule I or II or any narcotic drug listed in 
Schedule III, IV, or V if he finds:
    (1) That the substance is crude opium, poppy straw, concentrate of 
poppy straw, or coca leaves, in such quantity as the Administrator finds 
necessary to provide for medical, scientific, or other legitimate 
purposes;
    (2) That the substance is necessary to provide for medical and 
scientific needs or other legitimate needs of the United States during 
an emergency where domestic supplies of such substance or drug are found 
to be inadequate, or in any case in which the Administrator finds that 
competition among domestic manufacturers of the controlled substance is 
inadequate and will not be rendered adequate by the registration

[[Page 187]]

of additional manufacturers under section 303 of the Controlled 
Substances Act (21 U.S.C. 823); or
    (3) That the domestic supply of any controlled substance is 
inadequate for scientific studies, and that the importation of that 
substance for scientific purposes is only for delivery to officials of 
the United Nations, of the United States, or of any State, or to any 
person registered or exempted from registration under sections 1007 and 
1008 of the Act (21 U.S.C. 957 and 958).
    (4) That the importation of the controlled substance is for 
ballistics or other analytical or scientific purposes, and that the 
importation of that substance is only for delivery to officials of the 
United Nations, of the United States, or of any State, or to any person 
registered or exempted from registration under sections 1007 and 1008 of 
the Act (21 U.S.C. 957 and 958).
    (b) The Administrator may require that such non-narcotic controlled 
substances in Schedule III as he shall designate by regulation in Sec. 
1312.30 of this part be imported only pursuant to the issuance of an 
import permit. The Administrator may authorize the importation of such 
substances if he finds that the substance is being imported for medical, 
scientific or other legitimate uses.
    (c) If a non-narcotic substance listed in Schedule IV or V is also 
listed in Schedule I or II of the Convention on Psychotropic Substances, 
1971, it shall be imported only pursuant to the issuance of an import 
permit. The Administrator may authorize the importation of such 
substances if it is found that the substance is being imported for 
medical, scientific or other legitimate uses.
    (d) The Administrator may require an applicant to submit such 
documents or written statements of fact relevant to the application as 
he deems necessary to determine whether the application should be 
granted. The failure of the applicant to provide such documents or 
statements within a reasonable time after being requested to do so shall 
be deemed to be a waiver by the applicant of an opportunity to present 
such documents or facts for consideration by the Administrator in 
granting or denying the application.
    (e) Each import permit shall be issued in sextuplet and serially 
numbered, with all six copies bearing the same serial number and being 
designated ``original'' (Copy 1), ``duplicate'' (Copy 2), etc., 
respectively. All copies of import permits shall bear the signature of 
the Director or his delegate, and facsimiles of signatures shall not be 
used. No permit shall be altered or changed by any person after being 
signed by the Administrator or his delegate and any change or alteration 
upon the face of any permit after it shall have been signed by the 
Administrator or his delegate shall render it void and of no effect. 
Permits are not transferable. Each copy of the permit shall have printed 
or stamped thereon the disposition to be made thereof. Each permit shall 
be dated and shall certify that the importer named therein is thereby 
permitted as a registrant under the Act, to import, through the port 
named, one shipment of not to exceed the specified quantity of the named 
controlled substances, shipment to be made before a specified date. Not 
more than one shipment shall be made on a single import permit. The 
permit shall state that the Administrator is satisfied that the 
consignment proposed to be imported is required for legitimate purposes.
    (f) Notwithstanding paragraphs (a)(1) and (a)(2) of this section, 
the Administrator shall permit, pursuant to section 1002(a)(1) or 
1002(a)(2)(A) of the Act (21 U.S.C. 952(a)(1) or (a)(2)(A)), the 
importation of approved narcotic raw material (opium, poppy straw and 
concentrate of poppy straw) having as its source:
    (1) Turkey,
    (2) India,
    (3) Spain,
    (4) France,
    (5) Poland,
    (6) Hungary, and
    (7) Australia.
    (g) At least eighty (80) percent of the narcotic raw material 
imported into the United States shall have as its original source Turkey 
and India. Except under conditions of insufficient supplies of narcotic 
raw materials, not more than twenty (20) percent of the

[[Page 188]]

narcotic raw material imported into the United States annually shall 
have as its source Spain, France, Poland, Hungary and Australia.

[36 FR 23624, Dec. 11, 1971, as amended at 37 FR 15923, Aug. 8, 1972. 
Redesignated at 38 FR 26609, Sept. 24, 1973, and amended at 46 FR 41776, 
Aug. 18, 1981; 52 FR 17289, May 7, 1987; 73 FR 6851, Feb. 6, 2008]



Sec. 1312.14  Distribution of copies of import permit.

    Copies of the import permit shall be distributed and serve purposes 
as follows:
    (a) The original and quintuplet copies (Copy 1 and Copy 5) shall be 
transmitted by the Administration to the importer, who shall retain the 
quintuplet copy (Copy 5) on file as his record of authority for the 
importation, and shall transmit the original copy (Copy 1) to the 
foreign exporter. The foreign exporter will submit the original copy 
(Copy 1) to the proper governmental authority in the exporting country, 
if required, as a prerequisite to the issuance of an export 
authorization. This copy of the permit will accompany the shipment. Upon 
arrival of the imported merchandise, the District Director of the U.S. 
Customs Service at the port of entry will, after appraising the 
merchandise, forward the original copy (Copy 1) to the Drug Operations 
Section with a report on the reverse side of such copy, showing the name 
of the port of importation, date prepared, name and net quantity of each 
substance, and report of analysis of the merchandise entered.
    (b) The duplicate copy (Copy 2) shall be forwarded by the 
Administration to the proper governmental authorities of the exporting 
country.
    (c) The quadruplet copy (Copy 4) shall be forwarded by the 
Administration to the District Director of the U.S. Customs Service at 
the U.S. port of entry, which shall be the customs port of destination 
in the case of shipments transported under immediate transportation 
entries, in order that the District Director may compare it with the 
original copy (Copy 1) and the bill of lading upon arrival of the 
merchandise. If a discrepancy is noted between corresponding items upon 
different copies of a permit bearing the same serial number when 
compared by the District Director, he shall refuse to permit entry of 
the merchandise until the facts are communicated to the Administration 
and further instructions are received.
    (d) The triplicate copy (Copy 3) and sextuplet copy (Copy 6) shall 
be retained by the Administration.

[36 FR 7815, Apr. 24, 1971, as amended at 36 FR 13387, July 21, 1971. 
Redesignated at 38 FR 26609, Sept. 24, 1973, and further amended at 45 
FR 74715, Nov. 12, 1980; 51 FR 5319, Feb. 13, 1986; 53 FR 48244, Nov. 
30, 1988; 62 FR 13969, Mar. 24, 1997]



Sec. 1312.15  Shipments in greater or less amount than authorized.

    (a) If the shipment made under an import permit is greater than the 
maximum amount authorized to be imported under the permit, as determined 
at the weighing by the District Director of the U.S. Customs Service, 
such difference shall be seized subject to forfeiture, pending an 
explanation; except that shipments of substances exceeding the maximum 
authorized amount by less than 1 percent may be released to the importer 
upon the filing by him of an amended import permit. If the substance is 
included in Schedule I, it will be summarily forfeited to the 
Government.
    (b) If the shipment made under the permit is less than the maximum 
amount authorized to be imported under the permit as determined at the 
weighing by the District Director of the U.S. Customs Service, such 
difference, when ascertained by the Administration, shall be recredited 
to the tentative allotment against which the quantity covered by the 
permit was charged, and the balance of any such tentative allotment with 
any such recredits will remain available to the importer to whom made 
(unless previously revoked in whole or in part), for importations 
pursuant to any permit or permits as are requested and issued during the 
remainder of the calendar year to which the allotment is applicable. No 
permit shall be issued for importation of a quantity of controlled 
substances as a charge against the tentative allotment for a given 
calendar year, after the close of such calendar year, unless the 
Director of the

[[Page 189]]

Administration decides to make an exception for good cause shown.

[36 FR 7815, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973, 
and amended at 46 FR 28841, May 29, 1981]



Sec. 1312.16  Cancellation of permit; expiration date.

    (a) A permit may be canceled after being issued, at the request of 
the importer, provided no shipment has been made thereunder. In the 
event that a permit is lost, the Administrator may, upon the production 
by the importer of satisfactory proof, by affidavit or otherwise, issue 
a duplicate permit. Nothing in this part shall affect the right, hereby 
reserved by the Administrator, to cancel a permit at any time for proper 
cause.
    (b) An import permit shall not be valid after the date specified 
therein, and in no event shall the date be subsequent to 6 months after 
the date the permit is issued. Any unused import permit shall be 
returned for cancellation by the registrant to the Import/Export Unit, 
Drug Enforcement Administration. See the Table of DEA Mailing Addresses 
in Sec. 1321.01 of this chapter for the current mailing address.

[36 FR 7815, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973, 
and amended at 45 FR 74715, Nov. 12, 1980; 51 FR 5319, Feb. 13, 1986; 53 
FR 48244, Nov. 30, 1988; 62 FR 13969, Mar. 24, 1997; 75 FR 10682, Mar. 
9, 2010]



Sec. 1312.17  Special report from importers.

    Whenever requested by the Administrator, importers shall render to 
him not later than 30 days after receipt of the request therefor a 
statement under oath of the stocks of controlled substances on hand as 
of the date specified by the Administrator in his request, and, if 
desired by the Administrator, an estimate of the probable requirements 
for legitimate uses of the importer for any subsequent period that may 
be designated by the Administrator. In lieu of any special statement 
that may be considered necessary, the Administrator may accept the 
figures given upon the reports subsequent by said importer under part 
1304 of this chapter.

[36 FR 7815, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973, 
as amended at 62 FR 13969, Mar. 24, 1997]



Sec. 1312.18  Contents of import declaration.

    (a) Any non-narcotic controlled substance listed in Schedule III, 
IV, or V, not subject to the requirement of an import permit pursuant to 
Sec. 1312.13 (b) or (c) of this chapter, may be imported if that 
substance is needed for medical, scientific or other legitimate uses in 
the United States, and will be imported pursuant to a controlled 
substances import declaration.
    (b) Any person registered or authorized to import and desiring to 
import any non-narcotic controlled substance in Schedules III, IV, or V 
which is not subject to the requirement of an import permit as described 
in paragraph (a) of this section, must furnish a controlled substances 
import declaration on DEA Form 236 to the Import/Export Unit, Drug 
Enforcement Administration, not later than 15 calendar days prior to the 
proposed date of importation and distribute four copies of same as 
hereinafter directed in Sec. 1312.19. See the Table of DEA Mailing 
Addresses in Sec. 1321.01 of this chapter for the current mailing 
address.
    (c) DEA Form 236 must be executed in quintuplicate and will include 
the following information:
    (1) The name, address, and registration number of the importer; and 
the name and address and registration number of the import broker, if 
any; and
    (2) A complete description of the controlled substances to be 
imported, including drug name, dosage form, National Drug Code (NDC) 
number, the Administration Controlled Substances Code Number as set 
forth in part 1308 of this chapter, the number and size of packages or 
containers, the name and quantity of the controlled substance contained 
in any finished dosage units, and the net quantity of any controlled 
substance (expressed in anhydrous acid, base, or alkaloid) given in 
kilograms or parts thereof; and
    (3) The proposed import date, the foreign port of exportation to the 
United

[[Page 190]]

States, the port of entry, and the name, address, and registration 
number of the recipient in the United States; and
    (4) The name and address of the consignor in the foreign country of 
exportation, and any registration or license numbers if the consignor is 
required to have such numbers either by the country of exportation or 
under U.S. law.
    (d) Notwithstanding the time limitations included in paragraph (b) 
of this section, an applicant may obtain a special waiver of these time 
limitations in emergency or unusual instances, provided that a specific 
confirmation is received from the Administrator or his delegate advising 
the registrant to proceed pursuant to the special waiver.

[36 FR 7815, Apr. 24, 1971, as amended at 37 FR 15923, Aug. 8, 1972. 
Redesignated at 38 FR 26609, Sept. 24, 1973, and amended at 45 FR 74715, 
Nov. 12, 1980; 51 FR 5319, Feb. 13, 1986; 52 FR 17290, May 7, 1987; 62 
FR 13969, Mar. 24, 1997; 75 FR 10682, Mar. 9, 2010; 77 FR 4237, Jan. 27, 
2012]



Sec. 1312.19  Distribution of import declaration.

    The required five copies of the controlled substances import 
declaration will be distributed as follows:
    (a) Copy 1, Copy 2, and Copy 3 shall be transmitted to the foreign 
shipper. The foreign shipper will submit Copy 1 to the proper 
governmental authority in the foreign country, if required as a 
prerequisite to export authorization. Copy 1 will then accompany the 
shipment to its destination, and shall be retained on file by the 
importer. Copy 2 shall be detached and retained by the appropriate 
customs official of the foreign country. Copy 3 shall be removed by the 
District Director of the U.S. Customs Service at the port of entry, who 
shall sign and date the certification of customs on Copy 3, noting any 
changes from the entries made by the importer, and shall then forward 
that copy to the Drug Operations Section of the Administration.
    (b) Copy 4 shall be forwarded, within the time limit required in 
Sec. 1312.18, directly to the Import/Export Unit, Drug Enforcement 
Administration. See the Table of DEA Mailing Addresses in Sec. 1321.01 
of this chapter for the current mailing address.
    (c) Copy 5 shall be retained by the importer on file as his record 
of authority for the importation.

[36 FR 7815, Apr. 24, 1971, as amended at 36 FR 13387, July 21, 1971; 37 
FR 15923, Aug. 8, 1972. Redesignated at 38 FR 26609, Sept. 24, 1973, and 
further amended at 45 FR 74715, Nov. 12, 1980; 51 FR 5319, Feb. 13, 
1986; 53 FR 48244, Nov. 30, 1988; 62 FR 13969, Mar. 24, 1997; 75 FR 
10682, Mar. 9, 2010]

                  Exportation of Controlled Substances



Sec. 1312.21  Requirement of authorization to export.

    (a) No person shall in any manner export or cause to be exported 
from the United States any controlled substance listed in Schedule I or 
II, or any narcotic substance listed in Schedule III or IV, or any non-
narcotic substance in Schedule III which the Administrator has 
specifically designated by regulation in Sec. 1312.30 of this part or 
any non-narcotic substance in Schedule IV or V which is also listed in 
Schedule I or II of the Convention on Psychotropic Substances unless and 
until such person is properly registered under the Act (or exempted from 
registration) and the Administrator has issued a permit pursuant to 
Sec. 1312.23 of this part.
    (b) No person shall in any manner export or cause to be exported 
from the United States any non-narcotic controlled substance listed in 
Schedule III, IV, or V, excluding those described in paragraph (a) of 
this section, or any narcotic controlled substance listed in Schedule V, 
unless and until such person is properly registered under the Act (or 
exempted from registration) and has furnished a special controlled 
substance export invoice as provided by section 1003 of the Act (21 
U.S.C. 953(e)) to the Administrator pursuant to Sec. 1312.28 of this 
part.
    (c) A separate authorization request is obtained for each 
consignment of such controlled substances to be exported.

[36 FR 7815, Apr. 24, 1971, as amended at 37 FR 15923, Aug. 8, 1972. 
Redesignated at 38 FR 26609, Sept. 24, 1973, and amended at 52 FR 17290, 
May 7, 1987; 77 FR 4237, Jan. 27, 2012]

[[Page 191]]



Sec. 1312.22  Application for export permit.

    (a) An application for a permit to export controlled substances 
shall be made on DEA Form 161, and an application for a permit to 
reexport controlled substances shall be made on DEA Form 161R. Forms may 
be obtained from, and shall be filed with, the Import/Export Unit, Drug 
Enforcement Administration. See the Table of DEA Mailing Addresses in 
Sec. 1321.01 of this chapter for the current mailing address. Each 
application shall show the exporter's name, address, and registration 
number; a detailed description of each controlled substance desired to 
be exported including the drug name, dosage form, National Drug Code 
(NDC) number (in accordance with Food and Drug Administration 
regulations), the Administration Controlled Substance Code Number as set 
forth in Part 1308 of this chapter, the number and size of packages or 
containers, the name and quantity of the controlled substance contained 
in any finished dosage units, and the quantity of any controlled 
substance (expressed in anhydrous acid, base, or alkaloid) given in 
kilograms or parts thereof. The application shall include the name, 
address, and business of the consignee, foreign port of entry, the port 
of exportation, the approximate date of exportation, the name of the 
exporting carrier or vessel (if known, or if unknown it should be stated 
whether shipment will be made by express, freight, or otherwise, exports 
of controlled substances by mail being prohibited), the date and number, 
if any, of the supporting foreign import license or permit accompanying 
the application, and the authority by whom such foreign license or 
permit was issued. The application shall also contain an affidavit that 
the packages are labeled in conformance with obligations of the United 
States under international treaties, conventions, or protocols in effect 
on May 1, 1971. The affidavit shall further state that to the best of 
affiant's knowledge and belief, the controlled substances therein are to 
be applied exclusively to medical or scientific uses within the country 
to which exported, will not be reexported therefrom and that there is an 
actual need for the controlled substance for medical or scientific uses 
within such country, unless the application is submitted for reexport in 
accordance with paragraphs (c) and (d) of this section. In the case of 
exportation of crude cocaine, the affidavit may state that to the best 
of affiant's knowledge and belief, the controlled substances will be 
processed within the country to which exported, either for medical or 
scientific use within that country or for reexportation in accordance 
with the laws of that country to another for medical or scientific use 
within that country. The application shall be signed and dated by the 
exporter and shall contain the address from which the substances will be 
shipped for exportation.
    (b) There shall also be submitted with the application any import 
license or permit (and a translation thereof if in a foreign language) 
or a certified copy of any such license or permit issued by competent 
authorities in the country of destination, or other documentary evidence 
deemed adequate by the Administrator, showing that the merchandise is 
consigned to an authorized permittee, that it is to be applied 
exclusively to medical or scientific use within the country of 
destination, that it will not be reexported from such country, and that 
there is an actual need for the controlled substance for medical or 
scientific use within such country. (In the case of exportation of bulk 
coca leaf alkaloid, the submitted evidence need only show the material 
outlined in paragraph (a) of this section for such exportations.)
    (c) Notwithstanding paragraphs (a) and (b) of this section, the 
Administration may authorize any controlled substance listed in Schedule 
I or II, or any narcotic drug listed in Schedule III or IV, to be 
exported from the United States to a country for subsequent export from 
that country to another country, if each of the following conditions is 
met, in accordance with Sec. 1003(f) of the Act (21 U.S.C. 953(f)):
    (1) Both the country to which the controlled substance is exported 
from the United States (referred to in this section as the ``first 
country'') and the country to which the controlled substance is exported 
from the first country (referred to in this section as the

[[Page 192]]

``second country'') are parties to the Single Convention on Narcotic 
Drugs, 1961, and the Convention on Psychotropic Substances, 1971;
    (2) The first country and the second country have each instituted 
and maintain, in conformity with such Conventions, a system of controls 
of imports of controlled substances which the Administration deems 
adequate;
    (3) With respect to the first country, the controlled substance is 
consigned to a holder of such permits or licenses as may be required 
under the laws of such country, and a permit or license to import the 
controlled substance has been issued by the country;
    (4) With respect to the second country, substantial evidence is 
furnished to the Administration by the applicant for the export permit 
that--
    (i) The controlled substance is to be consigned to a holder of such 
permits or licenses as may be required under the laws of such country, 
and a permit or license to import the controlled substance is to be 
issued by the country; and
    (ii) The controlled substance is to be applied exclusively to 
medical, scientific, or other legitimate uses within the country;
    (5) The controlled substance will not be exported from the second 
country;
    (6) The person who exported the controlled substance from the United 
States has complied with paragraph (d) of this section and a permit to 
export the controlled substance from the United States has been issued 
by the Administration; and
    (7) Within 30 days after the controlled substance is exported from 
the first country to the second country, the person who exported the 
controlled substance from the United States must deliver to the 
Administration documentation certifying that such export from the first 
country has occurred. If the permit issued by the Administration 
authorized the reexport of a controlled substance from the first country 
to more than one second country, notification of each individual 
reexport shall be provided. This documentation shall be submitted on 
company letterhead, signed by a responsible company official, and shall 
include all of the following information:
    (i) Name of second country;
    (ii) Actual quantity shipped;
    (iii) Actual date shipped; and
    (iv) DEA export permit number for the original export.
    (d) Where a person is seeking to export a controlled substance for 
reexport in accordance with paragraph (c) of this section, the following 
requirements shall apply in addition to (and not in lieu of) the 
requirements of paragraphs (a) and (b) of this section:
    (1) Bulk substances will not be reexported in the same form as 
exported from the United States, i.e., the material must undergo further 
manufacturing process. This further manufactured material may only be 
reexported to a second country.
    (2) Finished dosage units, if reexported, must be in a commercial 
package, properly sealed and labeled for legitimate medical use in the 
second country.
    (3) Any proposed reexportation must be made known to the 
Administration at the time the initial DEA Form 161R is submitted. In 
addition, the following information must also be provided where 
indicated on the form:
    (i) Whether the drug or preparation will be reexported in bulk or 
finished dosage units;
    (ii) The product name, dosage strength, commercial package size, and 
quantity;
    (iii) The name of consignee, complete address, and expected shipment 
date, as well as the name and address of the ultimate consignee in the 
second country.
    (4) The application (DEA Form 161R) must also contain an affidavit 
that the consignee in the second country is authorized under the laws 
and regulations of the second country to receive the controlled 
substances. The affidavit must also contain the following statement, in 
addition to the statements required under paragraph (a) of this section:
    (i) That the packages are labeled in conformance with the 
obligations of the United States under the Single Convention on Narcotic 
Drugs, 1961, the Convention on Psychotropic Substances, 1971, and any 
amendments to such treaties;

[[Page 193]]

    (ii) That the controlled substances are to be applied exclusively to 
medical or scientific uses within the second country;
    (iii) That the controlled substances will not be further reexported 
from the second country, and
    (iv) That there is an actual need for the controlled substances for 
medical or scientific uses within the second country.
    (5) If the applicant proposes that the shipment of controlled 
substances will be separated into parts after it arrives in the first 
country and then reexported to more than one second country, the 
applicant shall so indicate on the DEA Form 161R, providing all the 
information required in this section for each second country.
    (6) Within 30 days after the controlled substance is exported from 
the United States, the person who exported the controlled substance 
shall deliver to the Administration documentation on the DEA Form 161R 
initially completed for the transaction certifying that such export 
occurred. This documentation shall be signed by a responsible company 
official and shall include all of the following information:
    (i) Actual quantity shipped;
    (ii) Actual date shipped; and
    (iii) DEA export permit number.
    (7) The controlled substance will be reexported from the first 
country to the second country (or second countries) no later than 180 
days after the controlled substance was exported from the United States.
    (8) Shipments that have been exported from the United States and are 
refused by the consignee in either the first or second country, or are 
otherwise unacceptable or undeliverable, may be returned to the 
registered exporter in the United States upon authorization of the 
Administration. In these circumstances, the exporter in the United 
States shall file a written request for the return of the controlled 
substances to the United States with a brief summary of the facts that 
warrant the return, along with a completed DEA Form 357, Application for 
Import Permit, with the Import/Export Unit, Drug Enforcement 
Administration. See the Table of DEA Mailing Addresses in Sec. 1321.01 
of this chapter for the current mailing address. The Administration will 
evaluate the request after considering all the facts as well as the 
exporter's registration status with the Administration. If the exporter 
provides sufficient documentation, the Administration will issue an 
import permit for the return of these drugs, and the exporter can then 
obtain an export permit from the country of original importation. The 
substance may be returned to the United States only after affirmative 
authorization is issued in writing by the Administration.
    (e) In considering whether to grant an application for a permit 
under paragraphs (c) and (d) of this section, the Administration shall 
consider whether the applicant has previously obtained such a permit 
and, if so, whether the applicant complied fully with the requirements 
of this section with respect to that previous permit.

[36 FR 7815, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973, 
and amended at 52 FR 17290, May 7, 1987; 62 FR 13969, Mar. 24, 1997; 72 
FR 72927, Dec. 26, 2007; 75 FR 10682, Mar. 9, 2010]



Sec. 1312.23  Issuance of export permit.

    (a) The Administrator may authorize exportation of any controlled 
substance listed in Schedule I or II or any narcotic controlled 
substance listed in Schedule III or IV if he finds that such exportation 
is permitted by subsections 1003(a), (b), (c), (d), or (f) of the Act 
(21 U.S.C. 953(a), (b), (c), (d), or (f).
    (b) The Administrator may require that such non-narcotic controlled 
substances in Schedule III as shall be designated by regulation in Sec. 
1312.30 of this part be exported only pursuant to the issuance of an 
export permit. The Administrator may authorize the exportation of such 
substances if he finds that such exportation is permitted by section 
1003(e) of the Act (21 U.S.C. 953(e)).
    (c) If a non-narcotic substance listed in Schedule IV or V is also 
listed in Schedule I or II of the Convention on Psychotropic Substances, 
it shall be exported only pursuant to the issuance of an export permit. 
The Administrator may authorize the exportation of such

[[Page 194]]

substances if he finds that such exportation is permitted by section 
1003(e) of the Act (21 U.S.C. 953(e)).
    (d) The Administrator may require an applicant to submit such 
documents or written statements of fact relevant to the application as 
he deems necessary to determine whether the application should be 
granted. The failure of the applicant to provide such documents or 
statements within a reasonable time after being requested to do so shall 
be deemed to be a waiver by the applicant of an opportunity to present 
such documents or facts for consideration by the Administrator in 
granting or denying the application.
    (e) Each export permit shall be issued in septuplet and serially 
numbered, with all seven copies bearing the same serial number and being 
designated ``original'' (Copy 1), ``duplicate'' (Copy 2), etc., 
respectively. Each export permit shall be predicated upon an import 
certificate or other documentary evidence. Export permits are not 
transferable.
    (f) No export permit shall be issued for the exportation, or 
reexportation, of any controlled substance to any country when the 
Administration has information to show that the estimates or assessments 
submitted with respect to that country for the current period, under the 
Single Convention on Narcotic Drugs, 1961, or the Convention on 
Psychotropic Substances, 1971, have been, or, considering the quantity 
proposed to be imported, will be exceeded. If it shall appear through 
subsequent advice received from the International Narcotics Control 
Board of the United Nations that the estimates or assessments of the 
country of destination have been adjusted to permit further importation 
of the controlled substance, an export permit may then be issued if 
otherwise permissible.

[36 FR 23625, Dec. 11, 1971, as amended at 37 FR 15923, Aug. 8, 1972. 
Redesignated at 38 FR 26609, Sept. 24, 1973, and amended at 52 FR 17290, 
May 7, 1987; 72 FR 72929, Dec. 26, 2007]



Sec. 1312.24  Distribution of copies of export permit.

    Copies of the export permit shall be distributed and serve purposes 
as follows:
    (a) The original, duplicate, and triplicate copies (Copy 1, Copy 2, 
and Copy 3) shall be transmitted by the Administration to the exporter 
who will retain the triplicate copy (Copy 3) as his record of authority 
for the exportation. The exporter shall present to the District Director 
of the U.S. Customs Service at the port of export and at the time of 
shipment, the original and duplicate copies (Copy 1 and Copy 2). After 
endorsing the port of export on the reverse side of the original and 
duplicate copies (Copy 1 and Copy 2) the District Director shall forward 
the endorsed original copy (Copy 1) with the shipment, and return the 
endorsed duplicate copy (Copy 2) to the Import/Export Unit, Drug 
Enforcement Administration. See the Table of DEA Mailing Addresses in 
Sec. 1321.01 of this chapter for the current mailing address.
    (b) The quadruplet copy (Copy 4) shall be forwarded by the 
Administrator to the District Director of the U.S. Customs Service at 
the port of export for comparison with the original copy (Copy 1) and 
for retention for the customs record.
    (c) The quintuplet copy (Copy 5) shall be forwarded by the 
Administration to the officer in the country of destination who issued 
the import certificate, or other documentary evidence upon which the 
export permit is founded.
    (d) The sextuplet and septuplet copies (Copy 6 and Copy 7) shall be 
retained by the Administration.

[36 FR 7815, Apr. 24, 1971, as amended at 36 FR 13387, July 21, 1971. 
Redesignated at 38 FR 26609, Sept. 24, 1973, and amended at 45 FR 74715, 
Nov. 12, 1980; 51 FR 5319, Feb. 13, 1986; 53 FR 48244, Nov. 30, 1988; 62 
FR 13969, Mar. 24, 1997; 75 FR 10682, Mar. 9, 2010]



Sec. 1312.25  Expiration date.

    An export permit shall not be valid after the date specified 
therein, which date shall conform to the expiration date specified in 
the supporting import certificate or other documentary evidence upon 
which the export permit is founded, but in no event shall the date be 
subsequent to 6 months after the date the permit is issued. Any unused 
export permit shall be returned by the

[[Page 195]]

permittee to the Import/Export Unit for cancellation.

[36 FR 7815, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973, 
and amended at 45 FR 74715, Nov. 12, 1980; 51 FR 5319, Feb. 13, 1986; 53 
FR 48244, Nov. 30, 1988; 62 FR 13969, Mar. 24, 1997; 77 FR 4237, Jan. 
27, 2012]



Sec. 1312.26  Records required of exporter.

    The exporter shall keep a record of any serial numbers that might 
appear on packages of narcotic drugs in quantities of one ounce or more 
in such a manner as will identify the foreign consignee, along with Copy 
3 of the export permit.



Sec. 1312.27  Contents of special controlled substances invoice.

    (a) A person registered or authorized to export any non-narcotic 
controlled substance listed in Schedule III, IV, or V, which is not 
subject to the requirement of an export permit pursuant to Sec. 1312.23 
(b) or (c), or any person registered or authorized to export any 
controlled substance in Schedule V, must furnish a special controlled 
substances export invoice on DEA Form 236 to the Import/Export Unit, 
Drug Enforcement Administration, not less than 15 calendar days prior to 
the proposed date of exportation, and distribute four copies of same as 
hereinafter directed in Sec. 1312.28 of this part. See the Table of DEA 
Mailing Addresses in Sec. 1321.01 of this chapter for the current 
mailing address.
    (b) This invoice must be executed by the exporter in quintuplicate 
and include the following information.
    (1) The name, address, and registration number, if any, of the 
exporter; and the name, address and registration number of the exporter 
broker, if any; and
    (2) A complete description of the controlled substances to be 
exported including the drug name, dosage form, National Drug Code (NDC) 
number, the Administration Controlled Substances Code Number as set 
forth in part 1308 of this chapter, the number and size of packages or 
containers, the name and quantity of the controlled substance contained 
in finished dosage units, and the net quantity of any controlled 
substance (expressed in anhydrous acid, base, or alkaloid) given in 
kilograms or parts thereof; and
    (3) The proposed export date, the port of exportation, the foreign 
port of entry, the carriers and shippers involved, method of shipment, 
the name of the vessel if applicable, and the name, address, and 
registration number, if any, of any forwarding agent utilized; and
    (4) The name and address of the consignee in the country of 
destination, and any registration or license number if the consignee is 
required to have such numbers either by the country of destination or 
under United States law. In addition, documentation must be provided to 
show that:
    (i) The consignee is authorized under the laws and regulations of 
the country of destination to receive the controlled substances, and 
that
    (ii) The substance is being imported for consumption within the 
importing country to satisfy medical, scientific or other legitimate 
purposes, and that
    (5) The reexport of non-narcotic controlled substances in Schedules 
III and IV, and controlled substances in Schedule V is not permitted 
under the authority of 21 U.S.C. 953(e), except as provided below:
    (i) Bulk substances will not be reexported in the same form as 
exported from the United States, i.e, the material must undergo further 
manufacturing process. This further manufactured material may only be 
reexported to a country of ultimate consumption.
    (ii) Finished dosage units, if reexported, will be in a commercial 
package, properly sealed and labeled for legitimate medical use in the 
country of destination.
    (iii) Any reexportation be made known to DEA at the time the initial 
DEA Form 236, Controlled Substances Import/Export Declaration is 
completed, by checking the box marked ``other'' on the certification. 
The following information will be furnished in the remarks section:
    (A) Indicate ``for reexport''.
    (B) Indicate if reexport is bulk or finished dosage units.
    (C) Indicate product name, dosage strength, commercial package size, 
and quantity.

[[Page 196]]

    (D) Indicate name of consignee, complete address, and expected 
shipment date, as well as, the name and address of the ultimate 
consignee in the country to where the substances will be reexported.
    (E) A statement that the consignee in the country of ultimate 
destination is authorized under the laws and regulations of the country 
of ultimate destination to receive the controlled substances.
    (iv) Shipments which have been exported from the United States and 
are refused by the consignee in the country of destination, or are 
otherwise unacceptable or undeliverable, may be returned to the 
registered exporter in the United States upon authorization of the Drug 
Enforcement Administration. In this circumstance, the exporter in the 
United States shall file a written request for reexport, along with a 
completed DEA Form 236, Import Declaration with the Import/Export Unit, 
Drug Enforcement Administration. See the Table of DEA Mailing Addresses 
in Sec. 1321.01 of this chapter for the current mailing address. A 
brief summary of the facts that warrant the return of the substance to 
the United States along with an authorization from the country of export 
will be included with the request. DEA will evaluate the request after 
considering all the facts as well as the exporter's registration status 
with DEA. The substance may be returned to the United States only after 
affirmative authorization is issued in writing by DEA.
    (c) Notwithstanding the time limitations included in paragraph (a) 
of this section, a registrant may obtain a special waiver of these time 
limitations in emergency or unusual instances; provided that a specific 
confirmation is received from the Administrator or his delegate advising 
the registrant to proceed pursuant to the special waiver.

[36 FR 7815, Apr. 24, 1971, as amended at 37 FR 15923, Aug. 8, 1972. 
Redesignated at 38 FR 26609, Sept. 24, 1973, and amended at 45 FR 74715, 
Nov. 12, 1980; 51 FR 5319, Feb. 13, 1986; 52 FR 17290, May 7, 1987; 62 
FR 13969, Mar. 24, 1997; 75 FR 10683, Mar. 9, 2010]



Sec. 1312.28  Distribution of special controlled substances invoice.

    The required five copies of the special controlled substances export 
invoice, DEA (or BND) Form 236, will be distributed as follows:
    (a) Copy 1 shall accompany the shipment and remain with the shipment 
to its destination.
    (b) Copy 2 shall accompany the shipment and will be detached and 
retained by appropriate customs officials at the foreign country of 
destination.
    (c) Copy 3 shall accompany the shipment and will be detached by the 
District Director of the U.S. Customs Service at the port of 
exportation, who shall sign and date the certification of customs on 
such Copy 3, noting any changes from the entries made by the exporter, 
and shall then promptly forward Copy 3 to the Import/Export Unit of the 
Administration.
    (d) Copy 4 shall be forwarded, within the time limit required in 
Sec. 1312.27 of this part, directly to the Import/Export Unit, Drug 
Enforcement Administration. The documentation required by Sec. 
1312.27(b)(4) of this part must be attached to this copy. See the Table 
of DEA Mailing Addresses in Sec. 1321.01 of this chapter for the 
current mailing address.
    (e) Copy 5 shall be retained by the exporter on file as his record 
of authority for the exportation.

[36 FR 7815, Apr. 24, 1971, as amended at 36 FR 13387, July 21, 1971. 
Redesignated at 38 FR 26609, Sept. 24, 1973, and amended at 45 FR 74715, 
Nov. 12, 1980; 51 FR 5319, Feb. 13, 1986; 52 FR 17291, May 7, 1987; 53 
FR 48244, Nov. 30, 1988; 62 FR 13969, Mar. 24, 1997; 75 FR 10683, Mar. 
9, 2010; 77 FR 4237, Jan. 27, 2012]



Sec. 1312.29  Domestic release prohibited.

    An exporter or a forwarding agent acting for an exporter must either 
deliver the controlled substances to the port or border, or deliver the 
controlled substances to a bonded carrier approved by the consignor for 
delivery to the port or border, and may not, under any other 
circumstances, release a shipment of controlled substances to anyone, 
including the foreign consignee or his agent, within the United States.

[[Page 197]]



Sec. 1312.30  Schedule III, IV, and V non-narcotic controlled 
substances requiring an import and export permit.

    The following Schedule III, IV, and V non-narcotic controlled 
substances have been specifically designated by the Administrator of the 
Drug Enforcement Administration as requiring import and export permits 
pursuant to sections 1002(b)(2) and 1003(e)(3) of the Act (21 U.S.C. 
952(b)(2) and 953(e)(3)):
    (a) Dronabinol (synthetic) in sesame oil and encapsulated in a soft 
gelatin capsule in a U.S. Food and Drug Administration approved product.
    (b) [Reserved]

[52 FR 17291, May 7, 1987, as amended at 64 FR 35930, July 2, 1999]

     Transshipment and In-Transit Shipment of Controlled Substances



Sec. 1312.31  Schedule I: Application for prior written approval.

    (a) A controlled substance listed in schedule I may be imported into 
the United States for transshipment, or may be transferred or 
transshipped within the United States for immediate exportation, 
provided that:
    (1) The controlled substance is necessary for scientific, medical, 
or other legitimate purposes in the country of destination, and
    (2) A transshipment permit has been issued by the Administrator.
    (b) An application for a transshipment permit must be submitted to 
the Import/Export Unit, Drug Enforcement Administration, at least 30 
days, or in the case of an emergency as soon as practicable, prior to 
the expected date of importation, transfer or transshipment. See the 
Table of DEA Mailing Addresses in Sec. 1321.01 of this chapter for the 
current mailing address. Each application shall contain the following:
    (1) The date of execution;
    (2) The identification and description of the controlled substance;
    (3) The net quantity thereof;
    (4) The number and size of the controlled substance containers;
    (5) The name, address, and business of the foreign exporter;
    (6) The foreign port of exportation;
    (7) The approximate date of exportation;
    (8) The identification of the exporting carrier;
    (9) The name, address and business of the importer, transferor, or 
transshipper;
    (10) The registration number, if any, of the importer, transferor or 
transshipper;
    (11) The U.S. port of entry;
    (12) The approximate date of entry;
    (13) The name, address and business of the consignee at the foreign 
port of entry;
    (14) The shipping route from the U.S. port of exportation to the 
foreign port of entry;
    (15) The approximate date of receipt by the consignee at the foreign 
port of entry; and
    (16) The signature of the importer, transferor or transshipper, or 
his agent accompanied by the agent's title.
    (c) An application shall be accompanied by an export license, 
permit, or a certified copy of the export license, permit, or other 
authorization, issued by a competent authority of the country of origin 
(or other documentary evidence deemed adequate by the Administrator).
    (d) An application shall be accompanied by an import license or 
permit or a certified copy of such license or permit issued by a 
competent authority of the country of destination (or other documentary 
evidence deemed adequate by the Administrator), indicating that the 
controlled substance:
    (1) Is to be applied exclusively to scientific, medical or other 
legitimate uses within the country of destination;
    (2) Will not be exported from such country; and
    (3) Is needed therein because there is an actual shortage thereof 
and a demand therefor for scientific, medical or other legitimate uses 
within such country.
    (e) Verification by an American consular officer of the signatures 
on a foreign import license or permit shall be required, if such license 
or permit does not bear the seal of the authority signing them.
    (f) The Administrator may require an applicant to submit such 
documents or written statements of fact relevant to the application as 
he deems necessary to determine whether the application

[[Page 198]]

should be granted. The failure of the applicant to provide such 
documents or statements within a reasonable time after being requested 
to do so shall be deemed to be a waiver by the applicant of an 
opportunity to present such documents or facts for consideration by the 
Administrator in granting or denying the application.
    (g) The Administrator shall, within 21 days from the date of receipt 
of the application, either grant or deny the application. The applicant 
shall be accorded an opportunity to amend the application, with the 
Administrator either granting or denying the amended application within 
7 days of its receipt. If the Administrator does not grant or deny the 
application within 21 days of its receipt, or in the case of an amended 
application, within 7 days of its receipt, the application shall be 
deemed approved and the applicant may proceed.

[36 FR 7815, Apr. 24, 1971, as amended at 37 FR 15923, Aug. 8, 1972. 
Redesignated at 38 FR 26609, Sept. 24, 1973, and further amended at 45 
FR 74715, Nov. 12, 1980; 51 FR 5319, Feb. 13, 1986; 53 FR 48244, Nov. 
30, 1988; 62 FR 13969, Mar. 24, 1997; 75 FR 10683, Mar. 9, 2010]



Sec. 1312.32  Schedules II, III, IV: Advance notice.

    (a) A controlled substance listed in Schedules II, III, or IV may be 
imported into the United States for transshipment, or may be transferred 
or transshipped within the United States for immediate exportation, 
provided that written notice is submitted to the Import/Export Unit, 
Drug Enforcement Administration, at least 15 days prior to the expected 
date of importation, transfer or transshipment. See the Table of DEA 
Mailing Addresses in Sec. 1321.01 of this chapter for the current 
mailing address.
    (b) Each advance notice shall contain those items required by Sec. 
1312.31 (b) and (c).

[36 FR 7815, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973, 
and amended at 45 FR 74715, Nov. 12, 1980; 51 FR 5319, Feb. 13, 1986; 53 
FR 48244, Nov. 30, 1988; 62 FR 13969, Mar. 24, 1997; 75 FR 10683, Mar. 
9, 2010]

                                Hearings



Sec. 1312.41  Hearings generally.

    (a) In any case where the Administrator shall hold a hearing 
regarding the denial of an application for an import, export or 
transshipment permit, the procedures for such hearing shall be governed 
generally by the adjudication procedures set forth in the Administrative 
Procedure Act (5 U.S.C. 551-559) and specifically by sections 1002 and 
1003 of the Act (21 U.S.C. 952 and 953), by Sec. Sec. 1312.42-1312.47, 
and by the procedures for administrative hearings under the Act set 
forth in Sec. Sec. 1316.41- 1316.67 of this chapter.
    (b) [Reserved]

[36 FR 23625, Dec. 11, 1971, as amended at 37 FR 15923, Aug. 8, 1972. 
Redesignated at 38 FR 26609, Sept. 24, 1973]



Sec. 1312.42  Purpose of hearing.

    (a) If requested by a person applying for an import, export, or 
transshipment permit, the Administrator shall hold a hearing for the 
purpose of receiving factual evidence regarding the issues involved in 
the issuance or denial of such permit to such person.
    (b) Extensive argument should not be offered into evidence but 
rather presented in opening or closing statements of counsel or in 
memoranda or proposed findings of fact and conclusions of law.

[36 FR 23625, Dec. 11, 1971, as amended at 37 FR 15923, Aug. 8, 1972. 
Redesignated at 38 FR 26609, Sept. 24, 1973]



Sec. 1312.43  Waiver or modification of rules.

    The Administrator of the presiding officer (with respect to matters 
pending before him) may modify or waive any rule in this part by notice 
in advance of the hearing, if he determines that no party in the hearing 
will be unduly prejudiced and the ends of justice will thereby be 
served. Such notice of modification or waiver shall be made a part of 
the record of the hearing.

[36 FR 23625, Dec. 11, 1971. Redesignated at 38 FR 26609, Sept. 24, 
1973]

[[Page 199]]



Sec. 1312.44  Request for hearing or appearance; waiver.

    (a) Any applicant entitled to a hearing pursuant to Sec. 1312.42 
and who desires a hearing on the denial of his application for an 
import, export, or transshipment permit shall, within 30 days after the 
date of receipt of the denial of his application, file with the 
Administrator a written request for a hearing in the form prescribed in 
Sec. 1316.47 of this chapter.
    (b) Any applicant entitled to a hearing pursuant to Sec. 1312.42 
may, within the period permitted for filing a request for a hearing, 
file with the Administrator a waiver of an opportunity for a hearing, 
together with a written statement regarding his position on the matters 
of fact and law involved in such hearing. Such statement, if admissible, 
shall be made a part of the record and shall be considered in light of 
the lack of opportunity for cross-examination in determining the weight 
to be attached to matters of fact asserted therein.
    (c) If any applicant entitled to a hearing pursuant to Sec. 1312.42 
fails to appear at the hearing, he shall be deemed to have waived his 
opportunity for the hearing unless he shows good cause for such failure.
    (d) If the applicant waives or is deemed to have waived this 
opportunity for the hearing, the Administrator may cancel the hearing, 
if scheduled, and issue his final order pursuant to Sec. 1312.47 
without a hearing.

[37 FR 15923, Aug. 8, 1972. Redesignated at 38 FR 26609, Sept. 24, 1973]



Sec. 1312.45  Burden of proof.

    At any hearing on the denial of an application for an import, 
export, or transshipment permit, the Administrator shall have the burden 
of proving that the requirements for such permit pursuant to sections 
1002, 1003, and 1004 of the Act (21 U.S.C. 952, 953, and 954) are not 
satisfied.

[37 FR 15924, Aug. 8, 1972. Redesignated at 38 FR 26609, Sept. 24, 1973]



Sec. 1312.46  Time and place of hearing.

    (a) If any applicant for an import, export, or transshipment permit 
requests a hearing on the issuance or denial of his application, the 
Administrator shall hold such hearing. Notice of the hearing shall be 
given to the applicant of the time and place at least 30 days prior to 
the hearing, unless the applicant waives such notice and requests the 
hearing be held at an earlier time, in which case the Administrator 
shall fix a date for such hearing as early as reasonably possible.
    (b) The hearing will commence at the place and time designated in 
the notice given pursuant to paragraph (a) of this section but 
thereafter it may be moved to a different place and may be continued 
from day to day or recessed to a later day without notice other than 
announcement thereof by the presiding officer at the hearing.

[37 FR 15924, Aug. 8, 1972. Redesignated at 38 FR 26609, Sept. 24, 1973]



Sec. 1312.47  Final order.

    As soon as practicable after the presiding officer has certified the 
record to the Administrator, the Administrator shall issue his order on 
the issuance or denial of the application for and import, export, or 
transshipment permit. The order shall include the findings of fact and 
conclusions of law upon which the order is based. The Administrator 
shall serve one copy of his order upon the applicant.

[37 FR 15924, Aug. 8, 1972. Redesignated at 38 FR 26609, Sept. 24, 1973]



PART 1313_IMPORTATION AND EXPORTATION OF LIST I AND LIST II 
CHEMICALS--Table of Contents



Sec.
1313.01 Scope.
1313.02 Definitions.
1313.05 Requirements for an established business relationship.
1313.08 Requirements for establishing a record as an importer.

                     Importation of Listed Chemicals

1313.12 Requirement of authorization to import.
1313.13 Contents of import declaration.
1313.14 Distribution of import declaration.
1313.15 Waiver of 15-day advance notice for regular importers.
1313.16 Transfers following importation.
1313.17 Return declaration or amendment to Form 486 for imports.

[[Page 200]]

                     Exportation of Listed Chemicals

1313.21 Requirement of authorization to export.
1313.22 Contents of export declaration.
1313.23 Distribution of export declaration.
1313.24 Waiver of 15-day advance notice for chemical exporters.
1313.25 Foreign import restrictions.
1313.26 Transfers following exportation.
1313.27 Return declaration or amendment to Form 486 for exports.

  Transshipments, In-Transit Shipments and International Transactions 
                       Involving Listed Chemicals

1313.31 Advance notice of importation for transshipment or transfer.
1313.32 Requirement of authorization for international transactions.
1313.33 Contents of an international transaction declaration.
1313.34 Distribution of the international transaction declaration.
1313.35 Return declaration or amendment to Form 486 for international 
          transactions.
1313.41 Suspension of shipments.
1313.42 Prohibition of shipments from certain foreign sources.

                                Hearings

1313.51 Hearings generally.
1313.52 Purpose of hearing.
1313.53 Waiver of modification of rules.
1313.54 Request for hearing.
1313.55 Burden of proof.
1313.56 Time and place of hearing.
1313.57 Final order.

    Authority: 21 U.S.C. 802, 830, 871(b), 971.

    Source: 54 FR 31665, Aug. 1, 1989, unless otherwise noted.



Sec. 1313.01  Scope.

    Procedures governing the importation, exportation, transshipment and 
in-transit shipment of listed chemicals pursuant to section 1018 of the 
Act (21 U.S.C. 971) are governed generally by that section and 
specifically by the sections of this part.

[54 FR 31665, Aug. 1, 1989, as amended at 60 FR 32465, June 22, 1995]



Sec. 1313.02  Definitions.

    Any term used in this part shall have the definition set forth in 
section 102 of the Act (21 U.S.C. 802) or part 1300 of this chapter.

[62 FR 13969, Mar. 24, 1997]



Sec. 1313.05  Requirements for an established business relationship.

    To document that an importer or exporter has an established business 
relationship with a customer, the importer or exporter must provide the 
Administrator with the following information in accordance with the 
waiver of 15-day advance notice requirements of Sec. 1313.15 or Sec. 
1313.24:
    (a) The name and street address of the chemical importer or exporter 
and of each regular customer;
    (b) The telephone number, contact person, and where available, the 
facsimile number for the chemical importer or exporter and for each 
regular customer;
    (c) The nature of the regular customer's business (i.e., importer, 
exporter, distributor, manufacturer, etc.), and if known, the use to 
which the listed chemical or chemicals will be applied;
    (d) The duration of the business relationship;
    (e) The frequency and number of transactions occurring during the 
preceding 12-month period;
    (f) The amounts and the listed chemical or chemicals involved in 
regulated transactions between the chemical importer or exporter and 
regular customer;
    (g) The method of delivery (direct shipment or through a broker or 
forwarding agent); and
    (h) Other information that the chemical importer or exporter 
considers relevant for determining whether a customer is a regular 
customer.

[72 FR 17407, Apr. 9, 2007]



Sec. 1313.08  Requirements for establishing a record as an importer.

    To establish a record as an importer, the regulated person must 
provide the Administrator with the following information in accordance 
with the waiver of the 15-day advance notice requirements of Sec. 
1313.15:
    (a) The name, DEA registration number (where applicable), street 
address, telephone number, and, where available, the facsimile number of 
the regulated person and of each foreign supplier; and

[[Page 201]]

    (b) The frequency and number of transactions occurring during the 
preceding 12 month period.

[72 FR 17407, Apr. 9, 2007]

                     Importation of Listed Chemicals



Sec. 1313.12  Requirement of authorization to import.

    (a) Each regulated person who imports a listed chemical that meets 
or exceeds the threshold quantities identified in Sec. 1310.04(f) or is 
a listed chemical for which no threshold has been established as 
identified in Sec. 1310.04(g) of this chapter, shall notify the 
Administrator of the importation not later than 15 days before the 
transaction is to take place.
    (b) A completed DEA Form 486 must be received by the Import/Export 
Unit, Drug Enforcement Administration, not later than 15 days prior to 
the importation. See the Table of DEA Mailing Addresses in Sec. 1321.01 
of this chapter for the current mailing address. A copy of the completed 
DEA Form 486 may be transmitted directly to the Drug Enforcement 
Administration through electronic facsimile media not later than 15 days 
prior to the importation.
    (c) The 15-day advance notification requirement for listed chemical 
imports may be waived for the following:
    (1) Any importation that meets both of the following requirements:
    (i) The regulated person has satisfied the requirements for 
reporting to the Administration as a regular importer of the listed 
chemicals.
    (ii) The importer intends to transfer the listed chemicals to a 
person who is a regular customer for the chemical, as defined in Sec. 
1300.02 of this chapter.
    (2) A specific listed chemical, as set forth in paragraph (f) of 
this section, for which the Administrator determines that advance 
notification is not necessary for effective chemical diversion control.
    (d) For imports where advance notification is waived pursuant to 
paragraph (c)(1) of this section, the DEA Form 486 must be received by 
the Drug Enforcement Administration, Import/Export Unit, on or before 
the date of importation through use of the mailing address listed in 
Sec. 1313.12(b) or through use of electronic facsimile media.
    (e) For importations where advance notification is waived pursuant 
to paragraph (c)(2) of this section no DEA Form 486 is required; 
however, the regulated person shall submit quarterly reports to the 
Import/Export Unit, Drug Enforcement Administration, no later than the 
15th day of the month following the end of each quarter. See the Table 
of DEA Mailing Addresses in Sec. 1321.01 of this chapter for the 
current mailing address. The report shall contain the following 
information regarding each individual importation:
    (1) The name of the listed chemical;
    (2) The quantity and date imported;
    (3) The name and full business address of the supplier;
    (4) The foreign port of embarkation; and
    (5) The port of entry.
    (f) The 15 day advance notification requirement set forth in 
paragraph (a) has been waived for imports of the following listed 
chemicals:
    (1) Acetone.
    (2) 2-Butanone (or Methyl Ethyl Ketone or MEK).
    (3) Toluene.

[54 FR 31665, Aug. 1, 1989, as amended at 59 FR 51367, Oct. 11, 1994; 60 
FR 32464, June 22, 1995; 66 FR 46520, Sept. 6, 2001; 67 FR 49569, July 
31, 2002; 72 FR 17407, Apr. 9, 2007; 75 FR 10683, Mar. 9, 2010; 77 FR 
4237, Jan. 27, 2012]



Sec. 1313.13  Contents of import declaration.

    (a) Any List I or List II chemical listed in Sec. 1310.02 of this 
chapter may be imported if that chemical is necessary for medical, 
commercial, scientific, or other legitimate uses within the United 
States. Chemical importations into the United States for immediate 
transfer/transshipment outside the United States must comply with the 
procedures set forth in Sec. 1313.31.
    (b) Any regulated person who desires to import a threshold or 
greater quantity of a listed chemical shall notify the Administration 
through procedures set forth in Sec. 1313.12 and distribute three 
copies of DEA Form 486 as directed in Sec. 1313.14.
    (c) The DEA Form 486 must be executed in triplicate and must include 
the following information:

[[Page 202]]

    (1) The name, address, telephone number, and, where available, the 
facsimile number of the chemical importer; the name, address, telephone 
number, and, where available, the facsimile number of the broker or 
forwarding agent (if any); and
    (2) The name and description of each listed chemical as it appears 
on the label or container, the name of each chemical as it is designated 
in 1310.02 of this chapter, the size or weight of container, the number 
of containers, the net weight of each listed chemical given in kilograms 
or parts thereof; and the gross weight of the shipment given in 
kilograms or parts thereof; and
    (3) The proposed import date, the foreign port of exportation and 
the first U.S. Customs Port of Entry; and
    (4) The name, address, telephone number, telex number, and, where 
available, the facsimile number of the consigner in the foreign country 
of exportation; and
    (5) The name, address, telephone number, and where available, the 
facsimile number of the person or persons to whom the importer intends 
to transfer the listed chemical and the quantity to be transferred to 
each transferee.
    (d) Any regulated person importing ephedrine, pseudoephedrine, or 
phenylpropanolamine must submit, on the import declaration, all 
information known to the importer on the chain of distribution of the 
chemical from the manufacturer to the importer. Ephedrine, 
pseudoephedrine, or phenylpropanolamine include each of the salts, 
optical isomers, and salts of optical isomers of the chemical.

[54 FR 31665, Aug. 1, 1989, as amended at 60 FR 32465, June 22, 1995; 72 
FR 17407, Apr. 9, 2007; 75 FR 10171, Mar. 5, 2010; 77 FR 4237, Jan. 27, 
2012]



Sec. 1313.14  Distribution of import declaration.

    The required three copies of the listed chemical import declaration 
(DEA Form 486) will be distributed as follows:
    (a) Copy 1 shall be retained on file by the regulated person as the 
official record of import. Import declaration forms involving a List I 
chemical must be retained for four years; declaration forms for List II 
chemical must be retained for two years.
    (b) Copy 2 is the Drug Enforcement Administration copy used to 
fulfill the notification requirements of Section 6053 of the Chemical 
Diversion and Trafficking Act of 1988, as specified in Sec. 1313.12.
    (c) Copy 3 shall be presented to the U.S. Customs Service along with 
the customs entry. If the import is a regulated transaction for which 
the 15-day advance notice requirement has been waived, the regulated 
person shall declare this information to the U.S. Customs Service 
Official by checking the block on the DEA Form 486 designated for this 
purpose.

[54 FR 31665, Aug. 1, 1989, as amended at 60 FR 32465, June 22, 1995; 77 
FR 4237, Jan. 27, 2012]



Sec. 1313.15  Waiver of 15-day advance notice for regular importers.

    (a) Each regulated person seeking designation as a ``regular 
importer'' shall provide, by certified mail return receipt requested, to 
the Administration such information as is required under Sec. 1313.08 
documenting their status as a regular importer.
    (b) Each regulated person making application under paragraph (a) of 
this section shall be considered a ``regular importer'' for purposes of 
waiving the 15-day advance notice, 30 days after receipt of the 
application by the Administration, as indicated on the return receipt, 
unless the regulated person is otherwise notified in writing by the 
Administration.
    (c) The Administrator, may, at any time, disqualify a regulated 
person's status as a regular importer on the grounds that the chemical 
being imported may be diverted to the clandestine manufacture of a 
controlled substance.
    (d) Unless the Administration notifies the chemical importer to the 
contrary, the qualification of a regular importer of any one of these 
three chemicals, acetone, 2-Butanone (MEK), or toluene, qualifies that 
importer as a regular importer of all three of these chemicals.

[[Page 203]]

    (e) All chemical importers shall be required to file a DEA Form 486 
as required by Section 1313.12.

[60 FR 32464, June 22, 1995, as amended at 62 FR 13969, Mar. 24, 1997; 
72 FR 17407, Apr. 9, 2007]



Sec. 1313.16  Transfers following importation.

    (a) In the case of a notice under Sec. 1313.12(a) submitted by a 
regulated person, if the transferee identified in the notice is not a 
regular customer, the importer may not transfer the listed chemical 
until after the expiration of the 15-day period beginning on the date on 
which the notice is submitted to the Administration.
    (b) After a notice under Sec. 1313.12(a) or (d) is submitted to the 
Administration, if circumstances change and the importer will not be 
transferring the listed chemical to the transferee identified in the 
notice, or will be transferring a greater quantity of the chemical than 
specified in the notice, the importer must update the notice to identify 
the most recent prospective transferee or the most recent quantity or 
both (as the case may be) and may not transfer the listed chemical until 
after the expiration of the 15-day period beginning on the date on which 
the update is submitted to the Administration, except that the 15-day 
restriction does not apply if the prospective transferee identified in 
the update is a regular customer. The preceding sentence applies with 
respect to changing circumstances regarding a transferee or quantity 
identified in an update to the same extent and in the same manner as the 
sentence applies with respect to changing circumstances regarding a 
transferee or quantity identified in the original notice under Sec. 
1313.12(a) or (d).
    (c) In the case of a transfer of a listed chemical that is subject 
to a 15-day restriction, the transferee involved shall, upon the 
expiration of the 15-day period, be considered to qualify as a regular 
customer, unless the Administration otherwise notifies the importer 
involved in writing.
    (d) With respect to a transfer of a listed chemical with which a 
notice or update referred to in Sec. 1313.12(a) or (d) is concerned:
    (1) The Administration--
    (i) May, in accordance with the same procedures as apply under 
Sec. Sec. 1313.51 through 1313.57, order the suspension of the transfer 
of the listed chemical by the importer involved, except for a transfer 
to a regular customer, on the ground that the chemical may be diverted 
to the clandestine manufacture of a controlled substance (without regard 
to the form of the chemical that may be diverted, including the 
diversion of a finished drug product to be manufactured from bulk 
chemicals to be transferred), subject to the Administration ordering the 
suspension before the expiration of the 15-day period with respect to 
the importation (in any case in which such a period applies); and
    (ii) May, for purposes of this paragraph (d), disqualify a regular 
customer on that ground.
    (2) From and after the time when the Administration provides written 
notice of the order under paragraph (d)(1)(i) of this section (including 
a statement of the legal and factual basis for the order) to the 
importer, the importer may not carry out the transfer.
    (e) For purposes of this section:
    (1) The term transfer, with respect to a listed chemical, includes 
the sale of the chemical.
    (2) The term transferee means a person to whom an importer transfers 
a listed chemical.

[72 FR 17407, Apr. 9, 2007]



Sec. 1313.17  Return declaration or amendment to Form 486 for imports.

    (a) Within 30 days after a transaction is completed, the importer 
must send to the Administration a return declaration containing 
particulars of the transaction, including the date, quantity, chemical, 
container, name of transferees, and any other information as the 
Administration may specify. A single return declaration may include the 
particulars of both the importation and distribution. If the importer 
has not distributed all chemicals imported by the end of the initial 30-
day period, the importer must file supplemental return declarations no 
later than 30 days from the date of any further distribution, until the 
distribution or

[[Page 204]]

other disposition of all chemicals imported under the import 
notification or any update are accounted for.
    (b) If an importation for which a Form 486 has been filed fails to 
take place, the importer must file an amended Form 486 notifying the 
Administration that the importation did not occur.

[72 FR 17408, Apr. 9, 2007]

                     Exportation of Listed Chemicals



Sec. 1313.21  Requirement of authorization to export.

    (a) No person shall export or cause to be exported from the United 
States any chemical listed in Sec. 1310.02 of this chapter, which meets 
or exceeds the threshold quantities identified in Sec. 1310.04(f) or is 
a listed chemical for which no threshold has been established as 
identified in Sec. 1310.04(g) of this chapter, until such time as the 
Administrator has been notified. Notification must be made not later 
than 15 days before the transaction is to take place. In order to 
facilitate the export of listed chemicals and implement the purpose of 
the Act, regulated persons may wish to provide notification to the 
Administration as far in advance of the 15 days as possible.
    (b) A completed DEA Form 486 must be received by the Import/Export 
Unit, Drug Enforcement Administration, not later than 15 days prior to 
the exportation. See the Table of DEA Mailing Addresses in Sec. 1321.01 
of this chapter for the current mailing address. A copy of the completed 
DEA Form 486 may be transmitted directly to the Drug Enforcement 
Administration through electronic facsimile media not later than 15 days 
prior to the exportation.
    (c) The 15-day advance notification requirement for listed chemical 
exports may be waived for:
    (1) Any regulated person who has satisfied the requirements of Sec. 
1313.24 for reporting to the Administration an established business 
relationship, as defined in Sec. 1300.02 of this chapter, with a 
foreign customer.
    (2) A specific listed chemical to a specified country, as set forth 
in paragraph (f) of this section, for which the Administrator determines 
that advance notification is not necessary for effective chemical 
diversion control.
    (d) For exports where advance notification is waived pursuant to 
paragraph (c)(1) of this section, the DEA Form 486 must be received by 
the Drug Enforcement Administration, Chemical Operations Section, on or 
before the date of exportation through use of the mailing address listed 
in Section 1313.12(b) or through use of electronic facsimile media.
    (e) For exportations where advance notification is waived pursuant 
to paragraph (c)(2) of this section, no DEA Form 486 is required; 
however, the regulated person shall file quarterly reports with the 
Import/Export Unit, Drug Enforcement Administration, no later than the 
15th day of the month following the end of each quarter. See the Table 
of DEA Mailing Addresses in Sec. 1321.01 of this chapter for the 
current mailing address. The report shall contain the following 
information regarding each individual exportation:
    (1) The name of the listed chemical;
    (2) The quantity and date exported;
    (3) The name and full business address of the foreign customer;
    (4) The port of embarkation; and
    (5) The foreign port of entry.
    (f) The 15 day advance notification requirement set forth in 
paragraph (a) of this section has been waived for exports of the 
following listed chemicals to the following countries:

------------------------------------------------------------------------
             Name of Chemical                          Country
------------------------------------------------------------------------
[Reserved]................................  ............................
------------------------------------------------------------------------

    (g) No person shall export or cause to be exported any listed 
chemical, knowing or having reasonable cause to believe the export is in 
violation of the laws of the country to which the chemical is exported 
or the chemical will be used to manufacture a controlled substance in 
violation of the Act or the laws of the country to which the chemical is 
exported. The Administration will publish a notice of foreign import 
restrictions for listed chemicals of

[[Page 205]]

which DEA has knowledge as provided in Sec. 1313.25.

[54 FR 31665, Aug. 1, 1989, as amended at 59 FR 51367, Oct. 11, 1994; 60 
FR 32464, June 22, 1995; 62 FR 13969, Mar. 24, 1997; 66 FR 46520, Sept. 
6, 2001; 67 FR 49569, July 31, 2002; 75 FR 10683, Mar. 9, 2010; 77 FR 
4237, Jan. 27, 2012]



Sec. 1313.22  Contents of export declaration.

    (a) Any List I or List II chemical listed in Sec. 1310.02 of this 
chapter which meets or exceeds the quantitative threshold criteria 
established in Sec. 1310.04(f) of this chapter may be exported if that 
chemical is needed for medical, commercial, scientific, or other 
legitimate uses.
    (b) Any regulated person who desires to export a threshold or 
greater quantity of a listed chemical shall notify the Administration 
through procedures outlined in Sec. 1313.21 and distribute three copies 
of DEA Form 486 as directed in Sec. 1313.23.
    (c) The DEA Form 486 must be executed in triplicate and must include 
all the following information:
    (1) The name, address, telephone number, telex number, and, where 
available, the facsimile number of the chemical exporter; the name, 
address, telephone number, telex number, and, where available, the 
facsimile number of the export broker, if any;
    (2) The name and description of each listed chemical as it appears 
on the label or container, the name of each listed chemical as it is 
designated in Sec. 1310.02 of this chapter, the size or weight of 
container, the number of containers, the net weight of each listed 
chemical given in kilograms or parts thereof, and the gross weight of 
the shipment given in kilograms or parts thereof;
    (3) The proposed export date, the U.S. Customs port of exportation, 
and the foreign port of entry; and
    (4) The name, address, telephone, telex, and where available, the 
facsimile number of the consignee in the country where the chemical 
shipment is destined; the name(s) and address(es) of any intermediate 
consignee(s).
    (d) Notwithstanding the time limitations included in paragraph (b) 
of this section, a regulated person may receive a waiver of the 15-day 
advance notification requirement following the procedures outlined in 
Sec. 1313.24.
    (e) Declared exports of listed chemicals which are refused, 
rejected, or otherwise deemed undeliverable may be returned to the U.S. 
chemical exporter of record. A brief written notification (this does not 
require a DEA Form 486) outlining the circumstances must be sent to the 
Import/Export Unit, Drug Enforcement Administration, following the 
return within a reasonable time. See the Table of DEA Mailing Addresses 
in Sec. 1321.01 of this chapter for the current mailing address. This 
provision does not apply to shipments that have cleared foreign customs, 
been delivered, and accepted by the foreign consignee. Returns to third 
parties in the United States will be regarded as imports.

[54 FR 31665, Aug. 1, 1989, as amended at 60 FR 32465, June 22, 1995; 67 
FR 49569, July 31, 2002; 75 FR 10683, Mar. 9, 2010]



Sec. 1313.23  Distribution of export declaration.

    The required three copies of the listed chemical export declaration 
(DEA Form 486) will be distributed as follows:
    (a) Copy 1 shall be retained on file by the chemical exporters as 
the official record of export. Export declaration forms involving a List 
I chemical must be retained for four years; declaration forms for list 
II chemical must be retained for two years.
    (b) Copy 2 is the Drug Enforcement Administration copy used to 
fulfill the notification requirements of Section 6053 of the Chemical 
Diversion and Trafficking Act of 1988, as specified in Sec. 1313.21
    (c) Copy 3 shall be presented to the U.S. Customs Service at the 
port of exit for each export of a listed chemical or chemicals on or 
before the day of exportation, and when possible, along with the 
Shippers Export Declaration.

[54 FR 31665, Aug. 1, 1989, as amended at 60 FR 32465, June 22, 1995; 61 
FR 51004, Sept. 30, 1996]



Sec. 1313.24  Waiver of 15-day advance notice for chemical exporters.

    (a) Each regulated person shall provide to the Administration the 
identity

[[Page 206]]

and information listed in the definition of established business 
relationship in Sec. 1300.02 of this chapter for an established 
business relationship with a foreign customer not later than August 31, 
1989.
    (b) Not later than October 31, 1989, each regular customer so 
identified in notifications made under Sec. 1313.24(a) shall be a 
regular customer for purposes of waiving the 15-day advance notice 
requirement, unless the regulated person is otherwise notified in 
writing by the Administration.
    (c) Each foreign customer identified on an initial DEA Form 486 
submitted after the effective date of the implementation of part 1313 
shall, after the expiration of the 15-day period, qualify as a regular 
customer, unless the Administration otherwise notifies the regulated 
person in writing.
    (d) Unless the Administration notifies the chemical exporter to the 
contrary, the qualification of a regular customer for any one of these 
three chemicals, acetone, 2-Butanone (MEK), or toluene, qualifies that 
customer as a regular customer for all three of these chemicals.
    (e) The Administrator may notify any chemical exporter that a 
regular customer has been disqualified or that a new customer for whom a 
notification has been submitted is not to be accorded the status of a 
regular customer. In the event of a disqualification of an established 
regular customer, the chemical exporter will be notified in writing of 
the reasons for such action.

[54 FR 31665, Aug. 1, 1989, as amended at 56 FR 55077, Oct. 24, 1991; 62 
FR 13969, Mar. 24, 1997; 75 FR 10684, Mar. 9, 2010; 77 FR 4237, Jan. 27, 
2012]



Sec. 1313.25  Foreign import restrictions.

    Any export from the United States in violation of the law of the 
country to which the chemical is exported is subject to the penalties of 
Title 21 United States Code 960(d).



Sec. 1313.26  Transfers following exportation.

    (a) In the case of a notice under Sec. 1313.21(a) submitted by a 
regulated person, if the transferee identified in the notice, i.e., the 
foreign importer, is not a regular customer, the regulated person may 
not transfer the listed chemical until after the expiration of the 15-
day period beginning on the date on which the notice is submitted to the 
Administration.
    (b) After a notice under Sec. 1313.21(a) is submitted to the 
Administration, if circumstances change and the exporter will not be 
transferring the listed chemical to the transferee identified in the 
notice, or will be transferring a greater quantity of the chemical than 
specified in the notice, the exporter must update the notice to identify 
the most recent prospective transferee or the most recent quantity or 
both (as the case may be) and may not transfer the listed chemical until 
after the expiration of the 15-day period beginning on the date on which 
the update is submitted to the Administration, except that the 15-day 
restriction does not apply if the prospective transferee identified in 
the update is a regular customer. The preceding sentence applies with 
respect to changing circumstances regarding a transferee or quantity 
identified in an update to the same extent and in the same manner as the 
sentence applies with respect to changing circumstances regarding a 
transferee or quantity identified in the original notice under paragraph 
(a) of this section.
    (c) In the case of a transfer of a listed chemical that is subject 
to a 15-day restriction, the transferee involved shall, upon the 
expiration of the 15-day period, be considered to qualify as a regular 
customer, unless the Administration otherwise notifies the exporter 
involved in writing.
    (d) With respect to a transfer of a listed chemical with which a 
notice or update referred to in Sec. 1313.21(a) is concerned:
    (1) The Administration--
    (i) May, in accordance with the same procedures as apply under 
Sec. Sec. 1313.51 through 1313.57, order the suspension of the transfer 
of the listed chemical by the exporter involved, except for a transfer 
to a regular customer, on the ground that the chemical may be diverted 
to the clandestine manufacture of a controlled substance (without regard 
to the form of the chemical that

[[Page 207]]

may be diverted, including the diversion of a finished drug product to 
be manufactured from bulk chemicals to be transferred), subject to the 
Administration ordering the suspension before the expiration of the 15-
day period with respect to the exportation (in any case in which such a 
period applies); and
    (ii) May, for purposes of this paragraph (d), disqualify a regular 
customer on that ground.
    (2) From and after the time when the Administration provides written 
notice of the order under paragraph (d)(1)(i) of this section (including 
a statement of the legal and factual basis for the order) to the 
exporter, the exporter may not carry out the transfer.
    (e) For purposes of this section:
    (1) The term transfer, with respect to a listed chemical, includes 
the sale of the chemical.
    (2) The term transferee means a person to whom an exporter transfers 
a listed chemical.

[72 FR 17408, Apr. 9, 2007]



Sec. 1313.27  Return declaration or amendment to Form 486 for exports.

    (a) Within 30 days after a transaction is completed, the exporter 
must send to the Administration a return declaration containing 
particulars of the transaction, including the date, quantity, chemical, 
container, name of transferees, and any other information as the 
Administration may specify.
    (b) If an exportation for which a Form 486 has been filed fails to 
take place, the exporter must file an amended Form 486 notifying the 
Administration that the exportation did not occur.

[72 FR 17408, Apr. 9, 2007]

  Transshipments, In-Transit Shipments and International Transactions 
                       Involving Listed Chemicals



Sec. 1313.31  Advance notice of importation for transshipment or
transfer.

    (a) A quantity of a chemical listed in Sec. 1310.02 of this chapter 
that meets or exceeds the threshold reporting requirements found in 
Sec. 1310.04(f) of this chapter may be imported into the United States 
for transshipment, or may be transferred or transshipped within the 
United States for immediate exportation, provided that advance notice is 
given to the Administration.
    (b) Advance notification must be provided to the Import/Export Unit, 
Drug Enforcement Administration, not later than 15 days prior to the 
proposed date the listed chemical will transship or transfer through the 
United States. See the Table of DEA Mailing Addresses in Sec. 1321.01 
of this chapter for the current mailing address. The written 
notification (not a DEA Form 486) shall contain the following 
information:
    (1) The date the notice was executed;
    (2) The complete name and description of the listed chemical as it 
appears on the label or container.
    (3) The name of the listed chemical as designated by Sec. 1310.02 
of this chapter.
    (4) The number of containers and the size or weight of the container 
for each listed item;
    (5) The net weight of each listed chemical given in kilograms or 
parts thereof;
    (6) The gross weight of the shipment given in kilograms or parts 
thereof;
    (7) The name, address, telephone number, telex number, business of 
the foreign exporter and, where available, the facsimile number;
    (8) The foreign port of exportation;
    (9) The approximate date of exportation;
    (10) The complete identification of the exporting carrier;
    (11) The name, address, business, telephone number, and, where 
available, the facsimile number of the importer, transferor, or 
transshipper;
    (12) The U.S. port of entry;
    (13) The approximate date of entry;
    (14) The name, address, telephone number, telex number, business of 
the consignee and, where available, facsimile number of the consignee at 
the foreign port of entry;
    (15) The shipping route from the U.S. port of exportation to the 
foreign port of entry at final destination;
    (16) The approximate date of receipt by the consignee at the foreign 
port of entry; and
    (17) The signature of the importer, transferor or transshipper, or 
his

[[Page 208]]

agent, accompanied by the agent's title.
    (c) Unless notified to the contrary prior to the expected date of 
delivery, the importation for transshipment or transfer is considered 
approved.
    (d) No waiver of the 15-day advance notice will be given for imports 
of listed chemicals in quantities meeting or exceeding threshold 
quantities for transshipment or transfer outside the United States.

[54 FR 31665, Aug. 1, 1989, as amended at 67 FR 49569, July 31, 2002; 75 
FR 10684, Mar. 9, 2010; 77 FR 4237, Jan. 27, 2012]



Sec. 1313.32  Requirement of authorization for international transactions.

    (a) A broker or trader shall notify the Administrator prior to an 
international transaction involving a listed chemical which meets or 
exceeds the threshold amount identified in Section 1310.04 of this 
chapter, in which the broker or trader participates. Notification must 
be made no later than 15 days before the transaction is to take place. 
In order to facilitate an international transaction involving listed 
chemicals and implement the purpose of the Act, regulated persons may 
wish to provide advance notification to the Administration as far in 
advance of the 15 days as possible.
    (b)(1) A completed DEA Form 486 must be received by the Import/
Export Unit, Drug Enforcement Administration, not later than 15 days 
prior to the international transaction. See the Table of DEA Mailing 
Addresses in Sec. 1321.01 of this chapter for the current mailing 
address.
    (2) A copy of the DEA Form 486 may be transmitted directly to the 
Drug Enforcement Administration, Import/Export Unit, through electronic 
facsimile media not later than 15 days prior to the exportation.
    (c) No person shall serve as a broker or trader for an international 
transaction involving a listed chemical knowing or having reasonable 
cause to believe that the transaction is in violation of the laws of the 
country to which the chemical is exported or the chemical will be used 
to manufacture a controlled substance in violation of the laws of the 
country to which the chemical is exported. The Administration will 
publish a notice of foreign import restrictions for listed chemicals of 
which DEA has knowledge as provided in Section 1313.25.
    (d) After a notice under paragraph (a) of this section is submitted 
to the Administration, if circumstances change and the broker or trader 
will not be transferring the listed chemical to the transferee 
identified in the notice, or will be transferring a greater quantity of 
the chemical than specified in the notice, the broker or trader must 
update the notice to identify the most recent prospective transferee or 
the most recent quantity or both (as the case may be). The preceding 
sentence applies with respect to changing circumstances regarding a 
transferee or quantity identified in an update to the same extent and in 
the same manner as the sentence applies with respect to changing 
circumstances regarding a transferee or quantity identified in the 
original notice under paragraph (a) of this section.
    (e) For purposes of this section:
    (1) The term transfer, with respect to a listed chemical, includes 
the sale of the chemical.
    (2) The term transferee means a person to whom an exporter transfers 
a listed chemical.

[60 FR 32465, June 22, 1995; 61 FR 17566, Apr. 22, 1996; 67 FR 49569, 
July 31, 2002; 72 FR 17408, Apr. 9, 2007; 75 FR 10684, Mar. 9, 2010; 77 
FR 4238, Jan. 27, 2012]



Sec. 1313.33  Contents of an international transaction declaration.

    (a) An international transaction involving a chemical listed in 
Sec. 1310.02 of this chapter which meets the threshold criteria 
established in Sec. 1310.04 of this chapter may be arranged by a broker 
or trader if the chemical is needed for medical, commercial, scientific, 
or other legitimate uses.
    (b) Any broker or trader who desires to arrange an international 
transaction involving a listed chemical which meets the criteria set 
forth in Section 1310.04 shall notify the Administration through the 
procedures outlined in Section 1313.32(b).
    (c) The DEA Form 486 must be executed in triplicate and must include 
all the following information:

[[Page 209]]

    (1) The name, address, telephone number, and, where available, the 
facsimile number of the chemical exporter; the name, address, telephone 
number, and, where available, the facsimile number of the chemical 
importer;
    (2) The name and description of each listed chemical as it appears 
on the label or container, the name of each listed chemical as it is 
designated in Section 1310.02 of this chapter, the size or weight of 
container, the number of containers, the net weight of each listed 
chemical given in kilograms or parts thereof, and the gross weight of 
the shipment given in kilograms or parts thereof;
    (3) The proposed export date, the port of exportation, and the port 
of importation; and
    (4) The name, address, telephone number, and, where available, the 
facsimile number of the consignee in the country where the chemical 
shipment is destined; the name(s) and address(es) of any intermediate 
consignee(s).

[60 FR 32465, June 22, 1995, as amended at 77 FR 4238, Jan. 27, 2012]



Sec. 1313.34  Distribution of the international transaction declaration.

    The required three copies of the DEA Form 486 will be distributed as 
follows:
    (a) Copies 1 and 3 shall be retained on file by the broker or trader 
as the official record of the international transaction. Declaration 
forms involving List I chemicals shall be retained for List II chemicals 
shall be retained for four years; declaration forms for two years.
    (b) Copy 2 is the Drug Enforcement Administration copy used to 
fulfill the notification requirements of Section 1313.32.

[60 FR 32465, June 22, 1995; 60 FR 35264, July 6, 1995]



Sec. 1313.35  Return declaration or amendment to Form 486 for 
international transactions.

    (a) Within 30 days after a transaction is completed, the broker or 
trader must send to the Administration a return declaration containing 
particulars of the transaction, including the date, quantity, chemical, 
container, name of transferees, and any other information as the 
Administration may specify.
    (b) If a transaction for which a Form 486 has been filed fails to 
take place, the broker or trader must file an amended Form 486 notifying 
the Administration that the transaction did not occur.

[72 FR 17409, Apr. 9, 2007]



Sec. 1313.41  Suspension of shipments.

    (a) The Administrator may suspend any importation or exportation of 
a chemical listed in Sec. 1310.02 of this chapter based on evidence 
that the chemical proposed to be imported or exported may be diverted to 
the clandestine manufacture of a controlled substance. If the 
Administrator so suspends, he shall provide written notice of such 
suspension to the regulated person. Such notice shall contain a 
statement of the legal and factual basis for the order.
    (b) Upon service of the order of suspension, the regulated person to 
whom the order applies under paragraph (a) of this section must, if he 
desires a hearing, file a written request for a hearing pursuant to 
Sec. Sec. 1313.51-1313.57.



Sec. 1313.42  Prohibition of shipments from certain foreign sources.

    (a) If the Administrator determines that a foreign manufacturer or 
distributor of ephedrine, pseudoephedrine, or phenylpropanolamine has 
refused to cooperate with a request by the Administrator for information 
known to the manufacturer or distributor on the distribution of the 
chemical, including sales, the Administrator may issue an order 
prohibiting the importation of the chemical in any case where the 
manufacturer or distributor is part of the chain of distribution.
    (b) Not later than 60 days prior to issuing the order to prohibit 
importation, the Administrator shall publish in the Federal Register a 
notice of intent to issue the order. During the 60-day period, imports 
from the foreign manufacturer or distributor may not be restricted under 
this section.

[75 FR 10172, Mar. 5, 2010]

[[Page 210]]

                                Hearings



Sec. 1313.51  Hearings generally.

    In any case where a regulated person requests a hearing regarding 
the suspension of a shipment of a listed chemical, the procedures for 
such hearing shall be governed generally by the procedures set forth in 
the Administrative Procedure Act (5 U.S.C. 551-559) and specifically by 
section 6053 of the Chemical Diversion and Trafficking Act (Pub. L. 100-
690), by 21 CFR 1313.52-1313.57, and by the procedures for 
administrative hearings under the Controlled Substances Act set forth in 
Sec. Sec. 1316.41-1316.67 of this chapter.



Sec. 1313.52  Purpose of hearing.

    If requested by a person entitled to a hearing, the Administrator 
shall cause a hearing to be held for the purpose of receiving factual 
evidence regarding the issues involved in the suspension of shipments 
within 45 days of the date of the request, unless the requesting party 
requests an extension of time.



Sec. 1313.53  Waiver of modification of rules.

    The Administrator or the presiding officer (with respect to matters 
pending before him) may modify or waive any rule in this part by notice 
in advance of the hearing, if he determines that no party in the hearing 
will be unduly prejudiced and the ends of justice will thereby be 
served. Such notice of modification or waiver shall be made a part of 
the record of the hearing.



Sec. 1313.54  Request for hearing.

    (a) Any person entitled to a hearing pursuant to Sec. 1313.52 and 
desiring a hearing shall, within 30 days after receipt of the notice to 
suspend the shipment, file with the Administrator a written request for 
a hearing in the form prescribed in Sec. 1316.47 of this chapter.
    (b) If any person entitled to a hearing or to participate in a 
hearing pursuant to Sec. 1313.41 fails to file a request for a hearing 
or a notice of appearance, or if he so files and fails to appear at the 
hearing, he shall be deemed to have waived his opportunity for the 
hearing or to participate in the hearing, unless he shows good cause for 
such failure.
    (c) If all persons entitled to a hearing or to participate in a 
hearing waive or are deemed to waive their opportunity for the hearing 
or to participate in the hearing, the Administrator may cancel the 
hearing, if scheduled, and issue his final order pursuant to Sec. 
1313.57.



Sec. 1313.55  Burden of proof.

    At any hearing regarding the suspension of shipments, the Agency 
shall have the burden of proving that the requirements of this part for 
such suspension are satisfied.



Sec. 1313.56  Time and place of hearing.

    (a) If any regulated person requests a hearing on the suspension of 
shipments, a hearing will be scheduled no later than 45 days after the 
request is made, unless the regulated person requests an extension to 
this date.
    (b) The hearing will commence at the place and time designated in 
the notice given pursuant to paragraph (a) of this section but 
thereafter it may be moved to a different place and may be continued 
from day to day or recessed to a later day without notice other than 
announcement thereof by the presiding officer at the hearing.



Sec. 1313.57  Final order.

    As soon as practicable after the presiding officer has certified the 
record to the Administrator, the Administrator shall issue his order 
regarding the suspension of shipment. The order shall include the 
findings of fact and conclusions of law upon which the order is based. 
The Administrator shall serve one copy of his order upon each party in 
the hearing.



PART 1314_RETAIL SALE OF SCHEDULED LISTED CHEMICAL PRODUCTS--Table 
of Contents



                            Subpart A_General

Sec.
1314.01 Scope.
1314.02 Applicability.
1314.03 Definitions.
1314.05 Requirements regarding packaging of nonliquid forms.
1314.10 Effect on state laws.
1314.15 Loss reporting.

[[Page 211]]

                  Subpart B_Sales by Regulated Sellers

1314.20 Restrictions on sales quantity.
1314.25 Requirements for retail transactions.
1314.30 Recordkeeping for retail transactions.
1314.35 Training of sales personnel.
1314.40 Self-certification.
1314.42 Self-certification fee; time and method of fee payment.
1314.45 Privacy protections.
1314.50 Employment measures.

                       Subpart C_Mail-Order Sales

1314.100 Sales limits for mail-order sales.
1314.101 Training of sales personnel.
1314.102 Self-certification.
1314.103 Self-certification fee; time and method of fee payment.
1314.105 Verification of identity for mail-order sales.
1314.110 Reports for mail-order sales.
1314.115 Distributions not subject to reporting requirements.

                      Subpart D_Order To Show Cause

1314.150 Order to show cause.
1314.155 Suspension pending final order.

    Authority: 21 U.S.C. 802, 830, 842, 871(b), 875, 877, 886a.

    Source: 71 FR 56024, Sept. 26, 2006, unless otherwise noted.



                            Subpart A_General



Sec. 1314.01  Scope.

    This part specifies the requirements for retail sales of scheduled 
listed chemical products to individuals for personal use.



Sec. 1314.02  Applicability.

    (a) This part applies to the following regulated persons who sell 
scheduled listed chemical products for personal use:
    (1) Regulated sellers of scheduled listed chemical products sold at 
retail for personal use through face-to-face sales at stores or mobile 
retail vendors.
    (2) Regulated persons who engage in a transaction with a non-
regulated person and who ship the products to the non-regulated person 
by the U.S. Postal Service or by private or common carriers.
    (b) The requirements in subpart A apply to all regulated persons 
subject to this part. The requirements in subpart B apply to regulated 
sellers as defined in Sec. 1300.02 of this chapter. The requirements in 
subpart C apply to regulated persons who ship the products to the 
customer by the U.S. Postal Service or by private or common carriers.



Sec. 1314.03  Definitions.

    As used in this part, the term ``mail-order sale'' means a retail 
sale of scheduled listed chemical products for personal use where a 
regulated person uses or attempts to use the U.S. Postal Service or any 
private or commercial carrier to deliver the product to the customer. 
Mail-order sale includes purchase orders submitted by phone, mail, fax, 
Internet, or any method other than face-to-face transaction.



Sec. 1314.05  Requirements regarding packaging of nonliquid forms.

    A regulated seller or mail order distributor may not sell a 
scheduled listed chemical product in nonliquid form (including gel caps) 
unless the product is packaged either in blister packs, with each 
blister containing no more than two dosage units or, if blister packs 
are technically infeasible, in unit dose packets or pouches.



Sec. 1314.10  Effect on State laws.

    Nothing in this part preempts State law on the same subject matter 
unless there is a positive conflict between this part and a State law so 
that the two cannot consistently stand together.



Sec. 1314.15  Loss reporting.

    (a) Each regulated person must report to the Special Agent in Charge 
of the DEA Divisional Office for the area in which the regulated person 
making the report is located, any unusual or excessive loss or 
disappearance of a scheduled listed chemical product under the control 
of the regulated person. The regulated person responsible for reporting 
a loss in-transit is the supplier.
    (b) Each report submitted under paragraph (a) of this section must, 
whenever possible, be made orally to the DEA Divisional Office for the 
area in which the regulated person making the report is located at the 
earliest practicable opportunity after the regulated person becomes 
aware of the circumstances involved.

[[Page 212]]

    (c) Written reports of losses must be filed within 15 days after the 
regulated person becomes aware of the circumstances of the event.
    (d) A report submitted under this section must include a description 
of the circumstances of the loss (in-transit, theft from premises, 
etc.).
    (e) A suggested format for the report is provided below:

                            Regulated Person

 Registration number (if applicable)____________________________________
 Name___________________________________________________________________
 Business address_______________________________________________________
 City___________________________________________________________________
 State__________________________________________________________________
 Zip____________________________________________________________________
 Business phone_________________________________________________________
 Date of loss___________________________________________________________
 Type of loss___________________________________________________________
 Description of circumstances___________________________________________



                  Subpart B_Sales by Regulated Sellers



Sec. 1314.20  Restrictions on sales quantity.

    (a) Without regard to the number of transactions, a regulated seller 
(including a mobile retail vendor) may not in a single calendar day sell 
any purchaser more than 3.6 grams of ephedrine base, 3.6 grams of 
pseudoephedrine base, or 3.6 grams of phenylpropanolamine base in 
scheduled listed chemical products.
    (b) A mobile retail vendor may not in any 30-day period sell an 
individual purchaser more than 7.5 grams of ephedrine base, 7.5 grams of 
pseudoephedrine base, or 7.5 grams of phenylpropanolamine base in 
scheduled listed chemical products.



Sec. 1314.25  Requirements for retail transactions.

    (a) Each regulated seller must ensure that sales of a scheduled 
listed chemical product at retail are made in accordance with this 
section and Sec. 1314.20.
    (b) The regulated seller must place the product so that customers do 
not have direct access to the product before the sale is made (in this 
paragraph referred to as ``behind-the-counter'' placement). For purposes 
of this paragraph, a behind-the-counter placement of a product includes 
circumstances in which the product is stored in a locked cabinet that is 
located in an area of the facility where customers do have direct 
access. Mobile retail vendors must place the product in a locked 
cabinet.
    (c) The regulated seller must deliver the product directly into the 
custody of the purchaser.



Sec. 1314.30  Recordkeeping for retail transactions.

    (a) Except for purchase by an individual of a single sales package 
containing not more than 60 milligrams of pseudoephedrine, the regulated 
seller must maintain, in accordance with criteria issued by the 
Administrator, a written or electronic list of each scheduled listed 
chemical product sale that identifies the products by name, the quantity 
sold, the names and addresses of the purchasers, and the dates and times 
of the sales (referred to as the ``logbook'').
    (b) The regulated seller must not sell a scheduled listed chemical 
product at retail unless the sale is made in accordance with the 
following:
    (1) The purchaser presents an identification card that provides a 
photograph and is issued by a State or the Federal Government, or a 
document that, with respect to identification, is considered acceptable 
for purposes of 8 CFR 274a.2(b)(1)(v)(A) and 274a.2(b)(1)(v)(B).
    (2) The purchaser signs the logbook as follows:
    (i) For written logbooks, enters in the logbook his name, address, 
and the date and time of the sale.
    (ii) For electronic logbooks, provides a signature using one of the 
following means:
    (A) Signing a device presented by the seller that captures 
signatures in an electronic format. The device must display the warning 
notice in paragraph (d) of this section. Any device used must preserve 
each signature in a manner that clearly links that signature to the 
other electronically captured logbook information relating to the 
prospective purchaser providing that signature.
    (B) Signing a bound paper book.
    (1) The bound paper book must include, for such purchaser, either--
    (i) A printed sticker affixed to the bound paper book at the time of 
sale

[[Page 213]]

that either displays the name of each product sold, the quantity sold, 
the name and address of the purchaser, and the date and time of the 
sale, or a unique identifier which can be linked to that electronic 
information, or
    (ii) A unique identifier that can be linked to that information and 
that is written into the book by the seller at the time of sale.
    (2) The purchaser must sign adjacent to the printed sticker or 
written unique identifier related to that sale. The bound paper book 
must display the warning notice in paragraph (d) of this section.
    (C) Signing a printed document that includes, for the purchaser, the 
name of each product sold, the quantity sold, the name and address of 
the purchaser, and the date and time of the sale. The document must be 
printed by the seller at the time of the sale. The document must contain 
a clearly identified signature line for a purchaser to sign. The printed 
document must display the warning notice in paragraph (d) of this 
section. Each signed document must be inserted into a binder or other 
secure means of document storage immediately after the purchaser signs 
the document.
    (3) The regulated seller must enter in the logbook the name of the 
product and the quantity sold. Examples of methods of recording the 
quantity sold include the weight of the product per package and number 
of packages of each chemical, the cumulative weight of the product for 
each chemical, or quantity of product by Universal Product Code. These 
examples do not exclude other methods of displaying the quantity sold. 
Such information may be captured through electronic means, including 
through electronic data capture through bar code reader or similar 
technology. Such electronic records must be provided pursuant to 
paragraph (g) of this section in a human readable form such that the 
requirements of paragraph (a) of this section are satisfied.
    (c) The logbook maintained by the seller must include the 
prospective purchaser's name, address, and the date and time of the 
sale, as follows:
    (1) If the purchaser enters the information, the seller must 
determine that the name entered in the logbook corresponds to the name 
provided on the identification and that the date and time entered are 
correct.
    (2) If the seller enters the information, the prospective purchaser 
must verify that the information is correct.
    (3) Such information may be captured through electronic means, 
including through electronic data capture through bar code reader or 
similar technology.
    (d) The regulated seller must include in the written or electronic 
logbook or display by the logbook, the following notice:

WARNING: Section 1001 of Title 18, United States Code, states that 
whoever, with respect to the logbook, knowingly and willfully falsifies, 
conceals, or covers up by any trick, scheme, or device a material fact, 
or makes any materially false, fictitious, or fraudulent statement or 
representation, or makes or uses any false writing or document knowing 
the same to contain any materially false, fictitious, or fraudulent 
statement or entry, shall be fined not more than $250,000 if an 
individual or $500,000 if an organization, imprisoned not more than five 
years, or both.

    (e) The regulated seller must maintain each entry in the written or 
electronic logbook for not fewer than two years after the date on which 
the entry is made.
    (f) A record under this section must be kept at the regulated 
seller's place of business where the transaction occurred, except that 
records may be kept at a single, central location of the regulated 
seller if the regulated seller has notified the Administration of the 
intention to do so. Written notification must be submitted by registered 
or certified mail, return receipt requested, to the Special Agent in 
Charge of the DEA Divisional Office for the area in which the records 
are required to be kept.
    (g) The records required to be kept under this section must be 
readily retrievable and available for inspection and copying by 
authorized employees of the Administration under the provisions of 
section 510 of the Act (21 U.S.C. 880).
    (h) A record developed and maintained to comply with a State law may 
be used to meet the requirements of

[[Page 214]]

this section if the record includes the information specified in this 
section.

[76 FR 74698, Dec. 1, 2011]



Sec. 1314.35  Training of sales personnel.

    Each regulated seller must ensure that its sales of a scheduled 
listed chemical product at retail are made in accordance with the 
following:
    (a) In the case of individuals who are responsible for delivering 
the products into the custody of purchasers or who deal directly with 
purchasers by obtaining payments for the products, the regulated seller 
has submitted to the Administration a self-certification that all such 
individuals have, in accordance with criteria issued by the 
Administration, undergone training provided by the regulated seller to 
ensure that the individuals understand the requirements that apply under 
this part.
    (b) The regulated seller maintains a copy of each self-certification 
and all records demonstrating that individuals referred to in paragraph 
(a) of this section have undergone the training.



Sec. 1314.40  Self-certification.

    (a) A regulated seller must submit to the Administration the self-
certification referred to in Sec. 1314.35(a) in order to sell any 
scheduled listed chemical product. The certification is not effective 
for purposes of this section unless, in addition to provisions regarding 
the training of individuals referred to in Sec. 1314.35(a), the 
certification includes a statement that the regulated seller understands 
each of the requirements that apply under this part and agrees to comply 
with the requirements.
    (b) When a regulated seller files the initial self-certification, 
the Administration will assign the regulated seller to one of twelve 
groups. The expiration date of the self-certification for all regulated 
sellers in any group will be the last day of the month designated for 
that group. In assigning a regulated seller to a group, the 
Administration may select a group with an expiration date that is not 
less than 12 months or more than 23 months from the date of the self-
certification. After the initial certification period, the regulated 
seller must update the self-certifications annually.
    (c) The regulated seller must provide a separate certification for 
each place of business at which the regulated seller sells scheduled 
listed chemical products at retail.



Sec. 1314.42  Self-certification fee; time and method of fee payment.

    (a) A regulated seller must pay a fee for each self-certification. 
For each initial application to self-certify, and for the renewal of 
each existing self-certification, a regulated seller shall pay a fee of 
$21.
    (b) The fee for self-certification shall be waived for any person 
holding a current, DEA registration in good standing as a pharmacy to 
dispense controlled substances.
    (c) A regulated seller shall pay the fee at the time of self-
certification.
    (d) Payment shall be made by credit card.
    (e) The self-certification fee is not refundable.

[73 FR 79323, Dec. 29, 2008]



Sec. 1314.45  Privacy protections.

    To protect the privacy of individuals who purchase scheduled listed 
chemical products, the disclosure of information in logbooks under Sec. 
1314.30 is restricted as follows:
    (a) The information shall be disclosed as appropriate to the 
Administration and to State and local law enforcement agencies.
    (b) The information in the logbooks shall not be accessed, used, or 
shared for any purpose other than to ensure compliance with this title 
or to facilitate a product recall to protect public health and safety.
    (c) A regulated seller who in good faith releases information in a 
logbook to Federal, State, or local law enforcement authorities is 
immune from civil liability for the release unless the release 
constitutes gross negligence or intentional, wanton, or willful 
misconduct.

[71 FR 56024, Sept. 26, 2006, as amended at 77 FR 4238, Jan. 27, 2012]



Sec. 1314.50  Employment measures.

    A regulated seller may take reasonable measures to guard against 
employing individuals who may present a

[[Page 215]]

risk with respect to the theft and diversion of scheduled listed 
chemical products, which may include, notwithstanding State law, asking 
applicants for employment whether they have been convicted of any crime 
involving or related to such products or controlled substances.



                       Subpart C_Mail-Order Sales



Sec. 1314.100  Sales limits for mail-order sales.

    (a) Each regulated person who makes a sale at retail of a scheduled 
listed chemical product and is required under Sec. 1310.03(c) of this 
chapter to submit a report of the sales transaction to the 
Administration may not in a single calendar day sell to any purchaser 
more than 3.6 grams of ephedrine base, 3.6 grams of pseudoephedrine 
base, or 3.6 grams of phenylpropanolamine base in scheduled listed 
chemical products.
    (b) Each regulated person who makes a sale at retail of a scheduled 
listed chemical product and is required under Sec. 1310.03(c) of this 
chapter to submit a report of the sales transaction to the 
Administration may not in any 30-day period sell to an individual 
purchaser more than 7.5 grams of ephedrine base, 7.5 grams of 
pseudoephedrine base, or 7.5 grams of phenylpropanolamine base in 
scheduled listed chemical products.



Sec. 1314.101  Training of sales personnel.

    Each regulated person who makes a sale at retail of a scheduled 
listed chemical product and is required under Sec. 1310.03(c) of this 
chapter to submit a report of the sales transaction to the 
Administration must ensure that its sales of a scheduled listed chemical 
product at retail are made in accordance with the following:
    (a) In the case of individuals who are responsible for preparing and 
packaging scheduled listed chemical products for delivery to purchasers 
through the Postal Service or any private or commercial carrier or who 
deal either directly or indirectly with purchasers by obtaining payments 
for the products, the regulated person has submitted to the 
Administration a self-certification that all such individuals have, in 
accordance with criteria issued by the Administration, undergone 
training provided by the regulated person to ensure that the individuals 
understand the requirements that apply under this part.
    (b) The regulated person maintains a copy of each self-certification 
and all records demonstrating that individuals referred to in paragraph 
(a) of this section have undergone the training.

[76 FR 20523, Apr. 13, 2011]



Sec. 1314.102  Self-certification.

    (a) A regulated person who makes a sale at retail of a scheduled 
listed chemical product and is required under Sec. 1310.03 of this 
chapter to submit a report of the sales transaction to the Attorney 
General must submit to the Administration the self-certification 
referred to in Sec. 1314.101(a) in order to sell any scheduled listed 
chemical product. The certification is not effective for purposes of 
this section unless, in addition to provisions regarding the training of 
individuals referred to in Sec. 1314.101(a), the certification includes 
a statement that the regulated person understands each of the 
requirements that apply in this part and agrees to comply with the 
requirements.
    (b) When a regulated person files the initial self-certification, 
the Administration will assign the regulated person to one of twelve 
groups. The expiration date of the self-certification for all regulated 
persons in any group will be the last day of the month designated for 
that group. In assigning a regulated person to a group, the 
Administration may select a group with an expiration date that is not 
less than 12 months or more than 23 months from the date of self-
certification. After the initial certification period, the regulated 
person must update the self-certification annually.
    (c) The regulated person who makes a sale at retail of a scheduled 
listed chemical product and is required under Sec. 1310.03 of this 
chapter to submit a report of the sales transaction to the Attorney 
General must provide a separate certification for each place of business 
at which the regulated person sells scheduled listed chemical products 
at retail.

[76 FR 20523, Apr. 13, 2011]

[[Page 216]]



Sec. 1314.103  Self-certification fee; time and method of fee payment.

    (a) Each regulated person who makes a sale at retail of a scheduled 
listed chemical product and is required under Sec. 1310.03 of this 
chapter to submit a report of the sales transaction to the 
Administration must pay a fee for each self-certification. For each 
initial application to self-certify, and for the renewal of each 
existing self-certification, a regulated seller shall pay a fee of $21.
    (b) The fee for self-certification shall be waived for any person 
holding a current, DEA registration in good standing as a pharmacy to 
dispense controlled substances.
    (c) A regulated person shall pay the fee at the time of self-
certification.
    (d) Payment shall be made by credit card.
    (e) The self-certification fee is not refundable.

[76 FR 20523, Apr. 13, 2011]



Sec. 1314.105  Verification of identity for mail-order sales.

    (a) Each regulated person who makes a sale at retail of a scheduled 
listed chemical product and is required under Sec. 1310.03(c) of this 
chapter to submit a report of the sales transaction to the 
Administration must, prior to shipping the product, receive from the 
purchaser a copy of an identification card that provides a photograph 
and is issued by a State or the Federal Government, or a document that, 
with respect to identification, is considered acceptable for purposes of 
8 CFR 274a.2(b)(1)(v)(A) and 274a.2(b)(1)(v)(B). Prior to shipping the 
product, the regulated person must determine that the name and address 
on the identification correspond to the name and address provided by the 
purchaser as part of the sales transaction. If the regulated person 
cannot verify the identities of both the purchaser and the recipient, 
the person may not ship the scheduled listed chemical product.
    (b) If the product is being shipped to a third party, the regulated 
person must comply with the requirements of paragraph (a) to verify that 
both the purchaser and the person to whom the product is being shipped 
live at the addresses provided. If the regulated person cannot verify 
the identities of both the purchaser and the recipient, the person may 
not ship the scheduled listed chemical product.



Sec. 1314.110  Reports for mail-order sales.

    (a) Each regulated person required to report under Sec. 1310.03(c) 
of this chapter must either:
    (1) Submit a written report, containing the information set forth in 
paragraph (b) of this section, on or before the 15th day of each month 
following the month in which the distributions took place. The report 
must be submitted under company letterhead, signed by the person 
authorized to sign on behalf of the regulated seller, to the Import/
Export Unit, Drug Enforcement Administration (see the Table of DEA 
Mailing Addresses in Sec. 1321.01 of this chapter for the current 
mailing address); or
    (2) Upon request to and approval by the Administration, submit the 
report in electronic form, either via computer disk or direct electronic 
data transmission, in such form as the Administration shall direct. 
Requests to submit reports in electronic form should be submitted to the 
Import/Export Unit, Drug Enforcement Administration. See the Table of 
DEA Mailing Addresses in Sec. 1321.01 of this chapter for the current 
mailing address.
    (b) Each monthly report must provide the following information for 
each distribution:
    (1) Supplier name and registration number;
    (2) Purchaser's name and address;
    (3) Name/address shipped to (if different from purchaser's name/
address);
    (4) Method used to verify the identity of the purchaser and, where 
applicable, person to whom product is shipped;
    (5) Name of the chemical contained in the scheduled listed chemical 
product and total quantity shipped (e.g. pseudoephedrine, 3 grams);
    (6) Date of shipment;
    (7) Product name;
    (8) Dosage form (e.g., tablet, liquid);
    (9) Dosage strength (e.g., 30mg, 60mg, per dose etc.);
    (10) Number of dosage units (e.g., 100 doses per package);
    (11) Package type (blister pack, etc.);

[[Page 217]]

    (12) Number of packages;
    (13) Lot number.

[71 FR 56024, Sept. 26, 2006, as amended at 75 FR 10684, Mar. 9, 2010]



Sec. 1314.115  Distributions not subject to reporting requirements.

    (a) The following distributions to nonregulated persons are not 
subject to the reporting requirements in Sec. 1314.110:
    (1) Distributions of sample packages when those packages contain not 
more than two solid dosage units or the equivalent of two dosage units 
in liquid form, not to exceed 10 milliliters of liquid per package, and 
not more than one package is distributed to an individual or residential 
address in any 30-day period.
    (2) Distributions by retail distributors that may not include face-
to-face transactions to the extent that such distributions are 
consistent with the activities authorized for a retail distributor as 
specified in the definition of retail distributor in Sec. 1300.02 of 
this chapter, except that this paragraph (a)(2) does not apply to sales 
of scheduled listed chemical products at retail.
    (3) Distributions to a resident of a long term care facility or 
distributions to a long term care facility for dispensing to or for use 
by a resident of that facility.
    (4) Distributions in accordance with a valid prescription.
    (b) The Administrator may revoke any or all of the exemptions listed 
in paragraph (a) of this section for an individual regulated person if 
the Administrator finds that drug products distributed by the regulated 
person are being used in violation of the regulations in this chapter or 
the Controlled Substances Act.

[[71 FR 56024, Sept. 26, 2006, as amended at 77 FR 4238, Jan. 27, 2012]



                      Subpart D_Order to Show Cause



Sec. 1314.150  Order To show cause.

    (a) If, upon information gathered by the Administration regarding 
any regulated seller or a distributor required to submit reports under 
Sec. 1310.03(c) of this chapter, the Administrator determines that a 
regulated seller or distributor required to submit reports under Sec. 
1310.03(c) of this chapter has sold a scheduled listed chemical product 
in violation of Section 402 of the Act (21 U.S.C. 842(a)(12) or (13)), 
the Administrator will serve upon the regulated seller or distributor an 
order to show cause why the regulated seller or distributor should not 
be prohibited from selling scheduled listed chemical products.
    (b) The order to show cause shall call upon the regulated seller or 
distributor to appear before the Administrator at a time and place 
stated in the order, which shall not be less than 30 days after the date 
of receipt of the order. The order to show cause shall also contain a 
statement of the legal basis for such hearing and for the prohibition 
and a summary of the matters of fact and law asserted.
    (c) Upon receipt of an order to show cause, the regulated seller or 
distributor must, if he desires a hearing, file a request for a hearing 
as specified in subpart D of part 1316 of this chapter. If a hearing is 
requested, the Administrator shall hold a hearing at the time and place 
stated in the order, as provided in part 1316 of this chapter.
    (d) When authorized by the Administrator, any agent of the 
Administration may serve the order to show cause.



Sec. 1314.155  Suspension pending final order.

    (a) The Administrator may suspend the right to sell scheduled listed 
chemical products simultaneously with, or at any time subsequent to, the 
service upon the seller or distributor required to file reports under 
Sec. 1310.03(c) of this chapter of an order to show cause why the 
regulated seller or distributor should not be prohibited from selling 
scheduled listed chemical products, in any case where he finds that 
there is an imminent danger to the public health or safety. If the 
Administrator so suspends, he shall serve with the order to show cause 
under Sec. 1314.150 an order of immediate suspension that shall contain 
a statement of his findings regarding the danger to public health or 
safety.

[[Page 218]]

    (b) Upon service of the order of immediate suspension, the regulated 
seller or distributor shall, as instructed by the Administrator:
    (1) Deliver to the nearest office of the Administration or to 
authorized agents of the Administration all of the scheduled listed 
chemical products in his or her possession; or
    (2) Place all of the scheduled listed chemical products under seal 
as described in Section 304 of the Act (21 U.S.C. 824(f)).
    (c) Any suspension shall continue in effect until the conclusion of 
all proceedings upon the prohibition, including any judicial review, 
unless sooner withdrawn by the Administrator or dissolved by a court of 
competent jurisdiction. Any regulated seller or distributor whose right 
to sell scheduled listed chemical products is suspended under this 
section may request a hearing on the suspension at a time earlier than 
specified in the order to show cause under Sec. 1314.150, which request 
shall be granted by the Administrator, who shall fix a date for such 
hearing as early as reasonably possible.



PART 1315_IMPORTATION AND PRODUCTION QUOTAS FOR EPHEDRINE, 
PSEUDOEPHEDRINE, AND PHENYLPROPANOLAMINE--Table of Contents



                      Subpart A_General Information

Sec.
1315.01 Scope.
1315.02 Definitions.
1315.03 Personal use exemption.
1315.05 Applicability.

                  Subpart B_Assessment of Annual Needs

1315.11 Assessment of annual needs.
1315.13 Adjustments of assessment of annual needs.

                Subpart C_Individual Manufacturing Quotas

1315.21 Individual manufacturing quotas.
1315.22 Procedure for applying for individual manufacturing quotas.
1315.23 Procedure for fixing individual manufacturing quotas.
1315.24 Inventory allowance.
1315.25 Increase in individual manufacturing quotas.
1315.26 Reduction in individual manufacturing quotas.
1315.27 Abandonment of quota.

                 Subpart D_Procurement and Import Quotas

1315.30 Procurement and import quotas.
1315.32 Obtaining a procurement quota.
1315.33 Power of attorney.
1315.34 Obtaining an import quota.
1315.36 Amending an import quota.

                           Subpart E_Hearings

1315.50 Hearings generally.
1315.52 Purpose of hearing.
1315.54 Waiver or modification of rules.
1315.56 Request for hearing or appearance; waiver.
1315.58 Burden of proof.
1315.60 Time and place of hearing.
1315.62 Final order.

    Source: 72 FR 37448, July 10, 2007, unless otherwise noted.

    Authority: 21 U.S.C. 802, 821, 826, 871(b), 952.



                      Subpart A_General Information



Sec. 1315.01  Scope.

    This part specifies procedures governing the establishment of an 
assessment of annual needs, procurement and manufacturing quotas 
pursuant to section 306 of the Act (21 U.S.C. 826), and import quotas 
pursuant to section 1002 of the Act (21 U.S.C. 952) for ephedrine, 
pseudoephedrine, and phenylpropanolamine.



Sec. 1315.02  Definitions.

    (a) Except as specified in paragraphs (b) and (c) of this section, 
any term contained in this part shall have the definition set forth in 
section 102 of the Act (21 U.S.C. 802) or part 1300 of this chapter.
    (b) The term net disposal means, for a stated period, the sum of 
paragraphs (b)(1) through (b)(3) of this section minus the sum of 
paragraphs (b)(4) and (b)(5) of this section:
    (1) The quantity of ephedrine, pseudoephedrine, or 
phenylpropanolamine distributed by the registrant to another person.
    (2) The quantity of that chemical used by the registrant in the 
production of (or converted by the registrant into) another chemical or 
product.
    (3) The quantity of that chemical otherwise disposed of by the 
registrant.

[[Page 219]]

    (4) The quantity of that chemical returned to the registrant by any 
purchaser.
    (5) The quantity of that chemical distributed by the registrant to a 
registered manufacturer of that chemical for purposes other than use in 
the production of, or conversion into, another chemical or in the 
manufacture of dosage forms of that chemical.
    (c) Ephedrine, pseudoephedrine, and phenylpropanolamine include 
their salts, optical isomers, and salts of optical isomers.



Sec. 1315.03  Personal use exemption.

    A person need not register as an importer, file an import 
declaration, and obtain an import quota if both of the following 
conditions are met:
    (a) The person purchases scheduled listed chemical products at 
retail and imports them for personal use, by means of shipping through 
any private or commercial carrier or the Postal Service.
    (b) In any 30-day period, the person imports no more than 7.5 grams 
of ephedrine base, 7.5 grams of pseudoephedrine base, and 7.5 grams of 
phenylpropanolamine base in scheduled listed chemical products.



Sec. 1315.05  Applicability.

    This part applies to all of the following:
    (a) Persons registered to manufacture (including repackaging or 
relabeling) or to import ephedrine, pseudoephedrine, or 
phenylpropanolamine as bulk chemicals.
    (b) Persons registered to manufacture (including repackaging or 
relabeling) or to import prescription and over-the-counter drug products 
containing ephedrine, pseudoephedrine, or phenylpropanolamine that may 
be lawfully marketed and distributed in the United States under the 
Federal Food, Drug, and Cosmetic Act.



                  Subpart B_Assessment of Annual Needs



Sec. 1315.11  Assessment of annual needs.

    (a) The Administrator shall determine the total quantity of 
ephedrine, pseudoephedrine, and phenylpropanolamine, including drug 
products containing ephedrine, pseudoephedrine, and phenylpropanolamine, 
necessary to be manufactured and imported during the following calendar 
year to provide for the estimated medical, scientific, research, and 
industrial needs of the United States, for lawful export requirements, 
and for the establishment and maintenance of reserve stocks.
    (b) In making his determinations, the Administrator shall consider 
the following factors:
    (1) Total net disposal of the chemical by all manufacturers and 
importers during the current and 2 preceding years;
    (2) Trends in the national rate of net disposal of each chemical;
    (3) Total actual (or estimated) inventories of the chemical and of 
all substances manufactured from the chemical, and trends in inventory 
accumulation;
    (4) Projected demand for each chemical as indicated by procurement 
and import quotas requested pursuant to Sec. 1315.32; and
    (5) Other factors affecting medical, scientific, research, and 
industrial needs in the United States, lawful export requirements, and 
the establishment and maintenance of reserve stocks, as the 
Administrator finds relevant, including changes in the currently 
accepted medical use in treatment with the chemicals or the substances 
which are manufactured from them, the economic and physical availability 
of raw materials for use in manufacturing and for inventory purposes, 
yield and stability problems, potential disruptions to production 
(including possible labor strikes), and recent unforeseen emergencies 
such as floods and fires.
    (c) The Administrator shall, on or before May 1 of each year, 
publish in the Federal Register, general notice of an assessment of 
annual needs for ephedrine, pseudoephedrine, and phenylpropanolamine 
determined by him under this section. A notice of the publication shall 
be mailed simultaneously to each person registered to manufacture or 
import the chemical.
    (d) The Administrator shall permit any interested person to file 
written comments on or objections to the proposed assessment of annual 
needs and

[[Page 220]]

shall designate in the notice the time during which the filings may be 
made.
    (e) The Administrator may, but is not required to, hold a public 
hearing on one or more issues raised by the comments and objections 
filed with him. In the event the Administrator decides to hold such a 
hearing, he shall publish a notice of the hearing in the Federal 
Register. The notice shall summarize the issues to be heard and set the 
time for the hearing, which shall not be less than 30 days after the 
date of publication of the notice.
    (f) After consideration of any comments or objections, or after a 
hearing if one is ordered by the Administrator, the Administrator shall 
issue and publish in the Federal Register the final order determining 
the assessment of annual needs for the chemicals. The order shall 
include the findings of fact and conclusions of law upon which the order 
is based. The order shall specify the date on which it shall take 
effect. A notice of the publication shall be mailed simultaneously to 
each person registered as a manufacturer or importer of the chemical.



Sec. 1315.13  Adjustments of the assessment of annual needs.

    (a) The Administrator may at any time increase or reduce the 
assessment of annual needs for ephedrine, pseudoephedrine, or 
phenylpropanolamine that has been previously fixed pursuant to Sec. 
1315.11.
    (b) In determining to adjust the assessment of annual needs, the 
Administrator shall consider the following factors:
    (1) Changes in the demand for that chemical, changes in the national 
rate of net disposal of the chemical, and changes in the rate of net 
disposal of the chemical by registrants holding individual manufacturing 
or import quotas for that chemical;
    (2) Whether any increased demand for that chemical, the national 
and/or changes in individual rates of net disposal of that chemical are 
temporary, short term, or long term;
    (3) Whether any increased demand for that chemical can be met 
through existing inventories, increased individual manufacturing quotas, 
or increased importation, without increasing the assessment of annual 
needs, taking into account production delays and the probability that 
other individual manufacturing quotas may be suspended pursuant to Sec. 
1315.24(b);
    (4) Whether any decreased demand for that chemical will result in 
excessive inventory accumulation by all persons registered to handle 
that chemical (including manufacturers, distributors, importers, and 
exporters), notwithstanding the possibility that individual 
manufacturing quotas may be suspended pursuant to Sec. 1315.24(b) or 
abandoned pursuant to Sec. 1315.27;
    (5) Other factors affecting medical, scientific, research, 
industrial, and importation needs in the United States, lawful export 
requirements, and reserve stocks, as the Administrator finds relevant, 
including changes in the currently accepted medical use in treatment 
with the chemical or the substances that are manufactured from it, the 
economic and physical availability of raw materials for use in 
manufacturing and for inventory purposes, yield and stability problems, 
potential disruptions to production (including possible labor strikes), 
and recent unforeseen emergencies such as floods and fires.
    (c) In the event that the Administrator determines to increase or 
reduce the assessment of annual needs for a chemical, the Administrator 
shall publish in the Federal Register general notice of an adjustment in 
the assessment of annual needs for that chemical as determined under 
this section. A notice of the publication shall be mailed simultaneously 
to each person registered as a manufacturer or importer of the chemical.
    (d) The Administrator shall permit any interested person to file 
written comments on or objections to the proposal and shall designate in 
the notice the time during which such filings may be made.
    (e) The Administrator may, but is not required to, hold a public 
hearing on one or more issues raised by the comments and objections 
filed with him. In the event the Administrator decides to hold such a 
hearing, he shall publish a notice of the hearing in the Federal 
Register. The notice shall summarize the issues to be heard and

[[Page 221]]

set the time for the hearing, which shall not be less than 10 days after 
the date of publication of the notice.
    (f) After consideration of any comments or objections, or after a 
hearing if one is ordered by the Administrator, the Administrator shall 
issue and publish in the Federal Register the final order determining 
the assessment of annual needs for the chemical. The order shall include 
the findings of fact and conclusions of law upon which the order is 
based. The order shall specify the date on which it shall take effect. A 
notice of the publication shall be mailed simultaneously to each person 
registered as a manufacturer or importer of the chemical.



                Subpart C_Individual Manufacturing Quotas



Sec. 1315.21  Individual manufacturing quotas.

    The Administrator shall, on or before July 1 of each year, fix for 
and issue to each person registered to manufacture in bulk ephedrine, 
pseudoephedrine, or phenylpropanolamine who applies for a manufacturing 
quota an individual manufacturing quota authorizing that person to 
manufacture during the next calendar year a quantity of that chemical. 
Any manufacturing quota fixed and issued by the Administrator is subject 
to his authority to reduce or limit it at a later date pursuant to Sec. 
1315.26 and to his authority to revoke or suspend it at any time 
pursuant to Sec. Sec. 1301.36, 1309.43, 1309.44, or 1309.45 of this 
chapter.



Sec. 1315.22  Procedure for applying for individual manufacturing quotas.

    Any person who is registered to manufacture ephedrine, 
pseudoephedrine, or phenylpropanolamine and who desires to manufacture a 
quantity of the chemical must apply on DEA Form 189 for a manufacturing 
quota for the quantity of the chemical. Copies of DEA Form 189 may be 
obtained from the Office of Diversion Control Web site, and must be 
filed (on or before April 1 of the year preceding the calendar year for 
which the manufacturing quota is being applied) with the Drug & Chemical 
Evaluation Section, Drug Enforcement Administration. See the Table of 
DEA Mailing Addresses in Sec. 1321.01 of this chapter for the current 
mailing address. A separate application must be made for each chemical 
desired to be manufactured. The applicant must state the following:
    (a) The name and DEA Chemical Code Number, as set forth in part 1310 
of this chapter, of the chemical.
    (b) For the chemical in each of the current and preceding 2 calendar 
years,
    (1) The authorized individual manufacturing quota, if any;
    (2) The actual or estimated quantity manufactured;
    (3) The actual or estimated net disposal;
    (4) The actual or estimated inventory allowance pursuant to Sec. 
1315.24; and
    (5) The actual or estimated inventory as of December 31.
    (c) For the chemical in the next calendar year,
    (1) The desired individual manufacturing quota; and
    (2) Any additional factors that the applicant finds relevant to the 
fixing of the individual manufacturing quota, including any of the 
following:
    (i) The trend of (and recent changes in) the applicant's and the 
national rates of net disposal.
    (ii) The applicant's production cycle and current inventory 
position.
    (iii) The economic and physical availability of raw materials for 
use in manufacturing and for inventory purposes.
    (iv) Yield and stability problems.
    (v) Potential disruptions to production (including possible labor 
strikes).
    (vi) Recent unforeseen emergencies such as floods and fires.

[72 FR 37448, July 10, 2007, as amended at 73 FR 73555, Dec. 3, 2008; 75 
FR 10684, Mar. 9, 2010]



Sec. 1315.23  Procedure for fixing individual manufacturing quotas.

    (a) In fixing individual manufacturing quotas for ephedrine, 
pseudoephedrine, and phenylpropanolamine, the Administrator shall 
allocate to each applicant who is currently manufacturing the chemical a 
quota equal to 100 percent of the estimated net disposal of that 
applicant for the next calendar year, adjusted--

[[Page 222]]

    (1) By the amount necessary to increase or reduce the estimated 
inventory of the applicant on December 31 of the current year to his 
estimated inventory allowance for the next calendar year, pursuant to 
Sec. 1315.24, and
    (2) By any other factors which the Administrator deems relevant to 
the fixing of the individual manufacturing quota of the applicant, 
including:
    (i) The trend of (and recent changes in) the applicant's and the 
national rates of net disposal,
    (ii) The applicant's production cycle and current inventory 
position,
    (iii) The economic and physical availability of raw materials for 
use in manufacturing and for inventory purposes,
    (iv) Yield and stability problems,
    (v) Potential disruptions to production (including possible labor 
strikes), and
    (vi) Recent unforeseen emergencies such as floods and fires.
    (b) In fixing individual manufacturing quotas for a chemical, the 
Administrator shall allocate to each applicant who is not currently 
manufacturing the chemical a quota equal to 100 percent of the 
reasonably estimated net disposal of that applicant for the next 
calendar year, as determined by the Administrator, adjusted--
    (1) By the amount necessary to provide the applicant his estimated 
inventory allowance for the next calendar year, pursuant to Sec. 
1315.24; and
    (2) By any other factors which the Administrator deems relevant to 
the fixing of the individual manufacturing quota of the applicant, 
including any of the following:
    (i) The trend of (and recent changes in) the national rate of net 
disposal.
    (ii) The applicant's production cycle and current inventory 
position.
    (iii) The economic and physical availability of raw materials for 
use in manufacturing and for inventory purposes.
    (iv) Yield and stability problems.
    (v) Potential disruptions to production (including possible labor 
strikes).
    (vi) Recent unforeseen emergencies such as floods and fires.
    (c) On or before March 1 of each year the Administrator shall adjust 
the individual manufacturing quota allocated for that year to each 
applicant in paragraph (a) of this section by the amount necessary to 
increase or reduce the actual inventory of the applicant to December 31 
of the preceding year to his estimated inventory allowance for the 
current calendar year, pursuant to Sec. 1315.24.



Sec. 1315.24  Inventory allowance.

    (a) For the purpose of determining individual manufacturing quotas 
pursuant to Sec. 1315.23, each registered manufacturer shall be allowed 
as a part of the quota an amount sufficient to maintain an inventory 
equal to either of the following:
    (1) For current manufacturers, 50 percent of his average estimated 
net disposal for the current calendar year and the last preceding 
calendar year; or
    (2) For new manufacturers, 50 percent of his reasonably estimated 
net disposal for the next calendar year as determined by the 
Administrator.
    (b) During each calendar year each registered manufacturer shall be 
allowed to maintain an inventory of a chemical not exceeding 65 percent 
of his estimated net disposal of that chemical for that year, as 
determined at the time his quota for that year was determined. At any 
time the inventory of a chemical held by a manufacturer exceeds 65 
percent of his estimated net disposal, his quota for that chemical is 
automatically suspended and shall remain suspended until his inventory 
is less than 60 percent of his estimated net disposal. The Administrator 
may, upon application and for good cause shown, permit a manufacturer 
whose quota is, or is likely to be, suspended under this paragraph to 
continue manufacturing and to accumulate an inventory in excess of 65 
percent of his estimated net disposal, upon such conditions and within 
such limitations as the Administrator may find necessary or desirable.
    (c) If, during a calendar year, a registrant has manufactured the 
entire quantity of a chemical allocated to him under an individual 
manufacturing quota, and his inventory of that chemical is less than 40 
percent of his estimated net disposal of that chemical for that year, 
the Administrator may, upon application pursuant to Sec. 1315.25, 
increase the quota of such registrant sufficiently to allow restoration 
of the

[[Page 223]]

inventory to 50 percent of the estimated net disposal for that year.



Sec. 1315.25  Increase in individual manufacturing quotas.

    (a) Any registrant who holds an individual manufacturing quota for a 
chemical may file with the Administrator an application on DEA Form 189 
for an increase in the registrant's quota to meet the registrant's 
estimated net disposal, inventory, and other requirements during the 
remainder of that calendar year.
    (b) The Administrator, in passing upon a registrant's application 
for an increase in the individual manufacturing quota, shall take into 
consideration any occurrences since the filing of the registrant's 
initial quota application that may require an increased manufacturing 
rate by the registrant during the balance of the calendar year. In 
passing upon the application the Administrator may also take into 
consideration the amount, if any, by which his determination of the 
total quantity for the chemical to be manufactured under Sec. 1315.11 
exceeds the aggregate of all the individual manufacturing quotas for the 
chemical, and the equitable distribution of such excess among other 
registrants.



Sec. 1315.26  Reduction in individual manufacturing quotas.

    The Administrator may at any time reduce an individual manufacturing 
quota for a chemical that he has previously fixed to prevent the 
aggregate of the individual manufacturing quotas and import quotas 
outstanding or to be granted from exceeding the assessment of annual 
needs that has been established for that chemical pursuant to Sec. 
1315.11, as adjusted pursuant to Sec. 1315.13. If a quota assigned to a 
new manufacturer pursuant to Sec. 1315.23(b), or if a quota assigned to 
any manufacturer is increased pursuant to Sec. 1315.24(c), or if an 
import quota issued to an importer pursuant to Sec. 1315.34, causes the 
total quantity of a chemical to be manufactured and imported during the 
year to exceed the assessment of annual needs that has been established 
for that chemical pursuant to Sec. 1315.11, as adjusted pursuant to 
Sec. 1315.13, the Administrator may proportionately reduce the 
individual manufacturing quotas and import quotas of all other 
registrants to keep the assessment of annual needs within the limits 
originally established, or, alternatively, the Administrator may reduce 
the individual manufacturing quota of any registrant whose quota is 
suspended pursuant to Sec. 1315.24(b) or Sec. Sec. 1301.36, 1309.43, 
1309.44, or 1309.45 of this chapter or is abandoned pursuant to Sec. 
1315.27.



Sec. 1315.27  Abandonment of quota.

    Any manufacturer assigned an individual manufacturing quota for a 
chemical pursuant to Sec. 1315.23 may at any time abandon his right to 
manufacture all or any part of the quota by filing with the Drug & 
Chemical Evaluation Section a written notice of the abandonment, stating 
the name and DEA Chemical Code Number, as set forth in part 1310 of this 
chapter, of the chemical and the amount which he has chosen not to 
manufacture. The Administrator may, in his discretion, allocate the 
amount among the other manufacturers in proportion to their respective 
quotas.



                 Subpart D_Procurement and Import Quotas



Sec. 1315.30  Procurement and import quotas.

    (a) To determine the estimated needs for, and to insure an adequate 
and uninterrupted supply of, ephedrine, pseudoephedrine, and 
phenylpropanolamine the Administrator shall issue procurement and import 
quotas.
    (b) A procurement quota authorizes a registered manufacturer to 
procure and use quantities of each chemical for the following purposes:
    (1) Manufacturing the bulk chemical into dosage forms.
    (2) Manufacturing the bulk chemical into other substances.
    (3) Repackaging or relabeling the chemical or dosage forms.
    (c) An import quota authorizes a registered importer to import 
quantities of the chemical for the following purposes:
    (1) Distribution of the chemical to a registered manufacturer that 
has a procurement quota for the chemical.

[[Page 224]]

    (2) Other distribution of the chemical consistent with the 
legitimate medical and scientific needs of the United States.



Sec. 1315.32  Obtaining a procurement quota.

    (a) Any person who is registered to manufacture ephedrine, 
pseudoephedrine, or phenylpropanolamine, or whose requirement of 
registration is waived pursuant to Sec. 1309.24 of this chapter, and 
who desires to use during the next calendar year any ephedrine, 
pseudoephedrine, or phenylpropanolamine for purposes of manufacturing 
(including repackaging or relabeling), must apply on DEA Form 250 for a 
procurement quota for the chemical. A separate application must be made 
for each chemical desired to be procured or used.
    (b) The applicant must state separately all of the following:
    (1) Each purpose for which the chemical is desired.
    (2) The quantity desired for each purpose during the next calendar 
year.
    (3) The quantities used and estimated to be used, if any, for that 
purpose during the current and preceding 2 calendar years.
    (c) If the purpose is to manufacture the chemical into dosage form, 
the applicant must state the official name, common or usual name, 
chemical name, or brand name of that form. If the dosage form produced 
is a controlled substance listed in any schedule, the applicant must 
also state the schedule number and National Drug Code Number, of the 
substance.
    (d) If the purpose is to manufacture another chemical, the applicant 
must state the official name, common or usual name, chemical name, or 
brand name of the substance and the DEA Chemical Code Number, as set 
forth in part 1310 of this chapter.
    (e) DEA Form 250 must be filed on or before April 1 of the year 
preceding the calendar year for which the procurement quota is being 
applied. Copies of DEA Form 250 may be obtained from the Office of 
Diversion Control Web site, and must be filed with the Drug & Chemical 
Evaluation Section, Drug Enforcement Administration. See the Table of 
DEA Mailing Addresses in Sec. 1321.01 of this chapter for the current 
mailing address.
    (f) The Administrator shall, on or before July 1 of the year 
preceding the calendar year during which the quota shall be effective, 
issue to each qualified applicant a procurement quota authorizing him to 
procure and use:
    (1) All quantities of the chemical necessary to manufacture products 
that the applicant is authorized to manufacture pursuant to Sec. 
1315.23; and
    (2) Such other quantities of the chemical as the applicant has 
applied to procure and use and are consistent with his past use, his 
estimated needs, and the total quantity of the chemical that will be 
produced.
    (g) Any person to whom a procurement quota has been issued may at 
any time request an adjustment in the quota by applying to the 
Administrator with a statement showing the need for the adjustment. The 
application must be filed with the Drug & Chemical Evaluation Section, 
Drug Enforcement Administration. See the Table of DEA Mailing Addresses 
in Sec. 1321.01 of this chapter for the current mailing address. The 
Administrator shall increase or decrease the procurement quota of the 
person if and to the extent that he finds, after considering the factors 
enumerated in paragraph (f) of this section and any occurrences since 
the issuance of the procurement quota, that the need justifies an 
adjustment.
    (h) Any person to whom a procurement quota has been issued, 
authorizing that person to procure and use a quantity of ephedrine, 
pseudoephedrine, or phenylpropanolamine during the current calendar 
year, must, at or before the time of placing an order with another 
manufacturer or importer requiring the distribution of a quantity of the 
chemical, certify in writing to the other registrant that the quantity 
of ephedrine, pseudoephedrine, or phenylpropanolamine ordered does not 
exceed the person's unused and available procurement quota of the 
chemical for the current calendar year. The written certification must 
be executed by a person authorized to sign the registration application 
pursuant to Sec. 1301.13 or

[[Page 225]]

Sec. 1309.32(g) of this chapter or by a person granted power of 
attorney under Sec. 1315.33 to sign the certifications. A copy of such 
certification must be retained by the person procuring the quantity of 
ephedrine, pseudoephedrine, or phenylpropanolamine for two years from 
the date of the certification. Registrants must not fill an order from 
persons required to apply for a procurement quota under paragraph (b) of 
this section unless the order is accompanied by a certification as 
required under this section.
    (i) The certification required by paragraph (h) of this section must 
contain all of the following:
    (1) The date of the certification.
    (2) The name and address of the registrant to whom the certification 
is directed.
    (3) A reference to the purchase order number to which the 
certification applies.
    (4) The name of the person giving the order to which the 
certification applies.
    (5) The name of the chemical to which the certification applies.
    (6) A statement that the quantity (expressed in grams) of the 
chemical to which the certification applies does not exceed the unused 
and available procurement quota of the chemical, issued to the person 
giving the order, for the current calendar year.
    (7) The signature of the individual authorized to sign a 
certification as provided in paragraph (h) of this section.

[72 FR 37448, July 10, 2007, as amended at 73 FR 73555, Dec. 3, 2008; 75 
FR 10684, Mar. 9, 2010]



Sec. 1315.33  Power of attorney.

    (a) A registrant may authorize one or more individuals, whether or 
not located at his registered location, to sign certifications required 
under Sec. 1315.32(h) on the registrant's behalf by executing a power 
of attorney for each such individual. The registrant shall retain the 
power of attorney in the files, with certifications required by Sec. 
1315.32(h), for the same period as any certification bearing the 
signature of the attorney. The power of attorney must be available for 
inspection together with other certification records.
    (b) A registrant may revoke any power of attorney at any time by 
executing a notice of revocation.
    (c) The power of attorney and notice of revocation must be similar 
to the following format:
    Power of Attorney for certifications of quota for procurement of 
ephedrine, pseudoephedrine, and phenylpropanolamine

------------ (Name of registrant)
------------ (Address of registrant)
------------ (DEA registration number)

    I, ------------ (name of person granting power), the undersigned, 
who am authorized to sign the current application for registration of 
the above-named registrant under the Controlled Substances Act or 
Controlled Substances Import and Export Act, have made, constituted, and 
appointed, and by these presents, do make, constitute, and appoint ----
-------- (name of attorney-in-fact), my true and lawful attorney for me 
in my name, place, and stead, to sign certifications of quota for 
procurement of ephedrine, pseudoephedrine, and phenylpropanolamine in 
accordance with Part 1315 of Title 21 of the Code of Federal 
Regulations. I hereby ratify and confirm all that said attorney must 
lawfully do or cause to be done by virtue hereof.
________________________________________________________________________

(Signature of person granting power)

I, ------------ (name of attorney-in-fact), hereby affirm that I am the 
person named herein as attorney-in-fact and that the signature affixed 
hereto is my signature.

(Signature of attorney-in-fact)

Witnesses:

1. ------------
2. ------------

Signed and dated on the ---- day of --, (year), at ------------.

                          Notice of Revocation

    The foregoing power of attorney is hereby revoked by the 
undersigned, who is authorized to sign the current application for 
registration of the above-named registrant under the Controlled 
Substances Act or the Controlled Substances Import and Export Act. 
Written notice of this revocation has been given to the attorney-in-fact 
------------ this same day.
________________________________________________________________________

(Signature of person revoking power)

Witnesses:

1. ------------
2. ------------
Signed and dated on the ---- day of --, (year), at ------------.


[[Page 226]]


    (d) A power of attorney must be executed by the person who signed 
the most recent application for DEA registration or reregistration; the 
person to whom the power of attorney is being granted; and two 
witnesses.
    (e) A power of attorney must be revoked by the person who signed the 
most recent application for DEA registration or reregistration, and two 
witnesses.

[73 FR 73555, Dec. 3, 2008]



Sec. 1315.34  Obtaining an import quota.

    (a) Any person who is registered to import ephedrine, 
pseudoephedrine, or phenylpropanolamine, or whose requirement of 
registration is waived pursuant to Sec. 1309.24(c) of this chapter, and 
who desires to import during the next calendar year any ephedrine, 
pseudoephedrine, or phenylpropanolamine or drug products containing 
these chemicals, must apply on DEA Form 488 for an import quota for the 
chemical. A separate application must be made for each chemical desired 
to be imported.
    (b) The applicant must provide the following information in the 
application:
    (1) The applicant's name and DEA registration number.
    (2) The name and address of a contact person and contact information 
(telephone number, fax number, e-mail address).
    (3) Name of the chemical and DEA Chemical Code number.
    (4) Type of product (bulk or finished dosage forms).
    (5) For finished dosage forms, the official name, common or usual 
name, chemical name, or brand name, NDC number, and the authority to 
market the drug product under the Federal Food, Drug and Cosmetic Act of 
each form to be imported.
    (6) The amount requested expressed in terms of base.
    (7) For the current and preceding two calendar years, expressed in 
terms of base:
    (i) Distribution/Sales--name, address, and registration number (if 
applicable) of each customer and the amount sold.
    (ii) Inventory as of December 31 (each form--bulk, in-process, 
finished dosage form).
    (iii) Acquisition--imports.
    (c) For each form of the chemical (bulk or dosage unit), the 
applicant must state the quantity desired for import during the next 
calendar year.
    (d) DEA Form 488 must be filed on or before April 1 of the year 
preceding the calendar year for which the import quota is being applied. 
Copies of DEA Form 488 may be obtained from the Office of Diversion 
Control Web site, and must be filed with the Drug & Chemical Evaluation 
Section. See the Table of DEA Mailing Addresses in Sec. 1321.01 of this 
chapter for the current mailing address.
    (e) The Administrator may at his discretion request additional 
information from an applicant.
    (f) On or before July 1 of the year preceding the calendar year 
during which the quota shall be effective, the Administrator shall issue 
to each qualified applicant an import quota authorizing him to import:
    (1) All quantities of the chemical necessary to manufacture products 
that registered manufacturers are authorized to manufacture pursuant to 
Sec. 1315.23; and
    (2) Such other quantities of the chemical that the applicant has 
applied to import and that are consistent with his past imports, the 
estimated medical, scientific, and industrial needs of the United 
States, the establishment and maintenance of reserve stocks, and the 
total quantity of the chemical that will be produced.

[72 FR 37448, July 10, 2007, as amended at 75 FR 10684, Mar. 9, 2010]



Sec. 1315.36  Amending an import quota.

    (a) An import quota authorizes the registered importer to import up 
to the set quantity of ephedrine, pseudoephedrine, or 
phenylpropanolamine and distribute the chemical or drug products on the 
DEA Form 488. An importer must apply to change the quantity to be 
imported.
    (b) Any person to whom an import quota has been issued may at any 
time request an increase in the quota quantity by applying to the 
Administrator with a statement showing the need for the adjustment. The 
application must be filed with the Drug & Chemical Evaluation Section, 
Drug Enforcement

[[Page 227]]

Administration. See the Table of DEA Mailing Addresses in Sec. 1321.01 
of this chapter for the current mailing address. The Administrator may 
increase the import quota of the person if and to the extent that he 
determines that the approval is necessary to provide for medical, 
scientific, or other legitimate purposes regarding the chemical. The 
Administrator shall specify a period of time for which the approval is 
in effect or shall provide that the approval is in effect until the 
Administrator notifies the applicant in writing that the approval is 
terminated.
    (c) With respect to the application under paragraph (b) of this 
section, the Administrator shall approve or deny the application within 
60 days of receiving the application. If the Administrator does not 
approve or deny the application within 60 days of receiving it, the 
application is deemed to be approved and the approval remains in effect 
until the Administrator notifies the applicant in writing that the 
approval is terminated.

[72 FR 37448, July 10, 2007, as amended at 75 FR 10685, Mar. 9, 2010]



                           Subpart E_Hearings



Sec. 1315.50  Hearings generally.

    The procedures for the hearing related to assessment of annual needs 
or to the issuance, adjustment, suspension, or denial of a 
manufacturing, procurement, or import quota are governed generally by 
the adjudication procedures set forth in the Administrative Procedure 
Act (5 U.S.C. 551-559) and specifically by section 1002 of the Act (21 
U.S.C. 952), by Sec. Sec. 1315.52 through 1315.62 of this part, and by 
the procedures for administrative hearings under the Act set forth in 
Sec. Sec. 1316.41 through 1316.67 of this chapter.



Sec. 1315.52  Purpose of hearing.

    (a) The Administrator may, in his sole discretion, hold a hearing 
for the purpose of receiving factual evidence regarding any one or more 
issues (to be specified by him) involved in the determination or 
adjustment of any assessment of national needs.
    (b) If requested by a person applying for or holding a procurement, 
import, or individual manufacturing quota, the Administrator shall hold 
a hearing for the purpose of receiving factual evidence regarding the 
issues involved in the issuance, adjustment, suspension, or denial of 
the quota to the person, but the Administrator need not hold a hearing 
on suspension of a quota under Sec. 1301.36 or Sec. 1309.43 of this 
chapter separate from a hearing on the suspension of registration under 
that section.
    (c) Extensive argument should not be offered into evidence, but 
rather presented in opening or closing statements of counsel or in 
memoranda or proposed findings of fact and conclusions of law.



Sec. 1315.54  Waiver or modification of rules.

    The Administrator or the presiding officer (with respect to matters 
pending before him) may modify or waive any rule in this part by notice 
in advance of the hearing, if he determines that no party in the hearing 
will be unduly prejudiced and the ends of justice will thereby be 
served. Such notice of modification or waiver shall be made a part of 
the record of the hearing.



Sec. 1315.56  Request for hearing or appearance; waiver.

    (a) Any applicant or registrant entitled to a hearing under Sec. 
1315.52 and who desires a hearing on the issuance, adjustment, 
suspension or denial of a procurement, import, or individual 
manufacturing quota must, within 30 days after the date of receipt of 
the issuance, adjustment, suspension or denial of the application, file 
with the Administrator a written request for a hearing in the form 
prescribed in Sec. 1316.47 of this chapter.
    (b) Any interested person who desires a hearing on the determination 
of an assessment of annual needs must, within the time prescribed in 
Sec. 1315.11(c), file with the Administrator a written request for a 
hearing in the form prescribed in Sec. 1316.47 of this chapter, 
including in the request a statement of the grounds for the hearing.
    (c) Any interested person who desires to participate in a hearing on 
the determination or adjustment of an assessment of annual needs, which 
hearing is ordered by the Administrator

[[Page 228]]

under Sec. 1315.11(c) or Sec. 1315.13(c), may do so by filing with the 
Administrator, within 30 days of the date of publication of notice of 
the hearing in the Federal Register, a written notice of his intention 
to participate in the hearing in the form prescribed in Sec. 1316.48 of 
this chapter.
    (d) Any person entitled to a hearing under Sec. 1315.52 or entitled 
to participate in a hearing under paragraph (c) of this section may, 
within the period permitted for filing a request for a hearing or notice 
of appearance, file with the Administrator a waiver of an opportunity 
for a hearing, together with a written statement regarding his position 
on the matters of fact and law involved in such hearing. The statement, 
if admissible, shall be made a part of the record and shall be 
considered in light of the lack of opportunity for cross-examination in 
determining the weight to be attached to matters of fact asserted.
    (e) If any person entitled to a hearing under Sec. 1315.52 or 
entitled to participate in a hearing under paragraph (c) of this section 
fails to file a request for a hearing or notice of appearance or if he 
so files and fails to appear at the hearing, he shall be deemed to have 
waived his opportunity for the hearing unless he shows good cause for 
such failure.
    (f) If all persons entitled to a hearing or to participate in a 
hearing waive or are deemed to waive their opportunity for the hearing 
or to participate in the hearing, the Administrator may cancel the 
hearing, if scheduled, and issue his final order under Sec. 1315.62 
without a hearing.



Sec. 1315.58  Burden of proof.

    (a) At any hearing regarding the determination or adjustment of an 
assessment of annual needs each interested person participating in the 
hearing shall have the burden of proving any propositions of fact or law 
asserted by him in the hearing.
    (b) At any hearing regarding the issuance, adjustment, suspension, 
or denial of a procurement, import, or individual manufacturing quota, 
the Administration shall have the burden of proving that the 
requirements of this part for such issuance, adjustment, suspension, or 
denial are satisfied.



Sec. 1315.60  Time and place of hearing.

    (a) If any applicant or registrant requests a hearing on the 
issuance, adjustment, suspension, or denial of his procurement, import, 
or individual manufacturing quota under Sec. 1315.54, the Administrator 
shall hold a hearing.
    (b) Notice of the hearing shall be given to the applicant or 
registrant of the time and place at least 30 days prior to the hearing, 
unless the applicant or registrant waives such notice and requests the 
hearing be held at an earlier time, in which case the Administrator 
shall fix a date for such hearing as early as reasonably possible.
    (c) The hearing shall commence at the place and time designated in 
the notice given under paragraph (b) of this section or in the notice of 
hearing published in the Federal Register pursuant to Sec. 1315.11(c) 
or Sec. 1315.13(c), but thereafter it may be moved to a different place 
and may be continued from day to day or recessed to a later day without 
notice other than announcement by the presiding officer at the hearing.



Sec. 1315.62  Final order.

    As soon as practicable after the presiding officer has certified the 
record to the Administrator, the Administrator shall issue his order on 
the determination or adjustment of the assessment of annual needs or on 
the issuance, adjustment, suspension, or denial of the procurement, 
import, or individual manufacturing quota, as the case may be. The order 
shall include the findings of fact and conclusions of law upon which the 
order is based. The order shall specify the date on which it shall take 
effect. The Administrator shall serve one copy of his order upon each 
party in the hearing.



PART 1316_ADMINISTRATIVE FUNCTIONS, PRACTICES, AND PROCEDURES--Table
of Contents



                  Subpart A_Administrative Inspections

Sec.
1316.01 Scope of subpart A.
1316.02 Definitions.
1316.03 Authority to make inspections.
1316.04 Exclusion from inspection.
1316.05 Entry.

[[Page 229]]

1316.06 Notice of inspection.
1316.07 Requirement for administrative inspection warrant; exceptions.
1316.08 Consent to inspection.
1316.09 Application for administrative inspection warrant.
1316.10 Administrative probable cause.
1316.11 Execution of warrants.
1316.12 Refusal to allow inspection with an administrative warrant.
1316.13 Frequency of administrative inspections.

        Subpart B_Protection of Researchers and Research Subjects

1316.21 Definitions.
1316.22 Exemption.
1316.23 Confidentiality of identity of research subjects.
1316.24 Exemption from prosecution for researchers.

                    Subpart C_Enforcement Proceedings

1316.31 Authority for enforcement proceeding.
1316.32 Notice of proceeding; time and place.
1316.33 Conduct of proceeding.
1316.34 Records of proceeding.

                    Subpart D_Administrative Hearings

1316.41 Scope of subpart D.
1316.42 Definitions.
1316.43 Information; special instructions.
1316.44 Waiver or modification of rules.
1316.45 Filings; address; hours.
1316.46 Inspection of record.
1316.47 Request for hearing.
1316.48 Notice of appearance.
1316.49 Waiver of hearing.
1316.50 Appearance; representation; authorization.
1316.51 Conduct of hearing and parties; ex parte communications.
1316.52 Presiding officer.
1316.53 Time and place of hearing.
1316.54 Prehearing conference.
1316.55 Prehearing ruling.
1316.56 Burden of proof.
1316.57 Submission of documentary evidence and affidavits and 
          identification of witnesses subsequent to prehearing 
          conference.
1316.58 Summary of testimony; affidavits.
1316.59 Submission and receipt of evidence.
1316.60 Objections; offer of proof.
1316.61 Exceptions to rulings.
1316.62 Appeal from ruling of presiding officer.
1316.63 Official transcript; index; corrections.
1316.64 Proposed findings of fact and conclusions of law.
1316.65 Report and record.
1316.66 Exceptions.
1316.67 Final order.
1316.68 Copies of petitions for judicial review.

    Source: 36 FR 7820, Apr. 24, 1971, unless otherwise noted. 
Redesignated at 38 FR 26609, Sept. 24, 1973.



                  Subpart A_Administrative Inspections

    Authority: 21 U.S.C. 822(f), 830(a), 871(b), 880, 958(f), 965.



Sec. 1316.01  Scope of subpart A.

    Procedures regarding administrative inspections and warrants 
pursuant to sections 302(f), 510, 1008(d), and 1015 of the Act (21 
U.S.C. 822(f), 880, 958(d), and 965) are governed generally by those 
sections and specifically by the sections of this subpart.



Sec. 1316.02  Definitions.

    As used in this subpart, the following terms shall have the meanings 
specified:
    (a) The term Act means the Controlled Substances Act (84 Stat. 1242; 
21 U.S.C. 801) and/or the Controlled Substances Import and Export Act 
(84 Stat. 1285; 21 U.S.C. 951).
    (b) The term Administration means the Drug Enforcement 
Administration.
    (c) The term controlled premises means--
    (1) Places where original or other records or documents required 
under the Act are kept or required to be kept, and
    (2) Places, including factories, warehouses, or other establishments 
and conveyances, where persons registered under the Act or exempted from 
registration under the Act, or regulated persons may lawfully hold, 
manufacture, or distribute, dispense, administer, or otherwise dispose 
of controlled substances or listed chemicals or where records relating 
to those activities are maintained.
    (d) The term Administrator means the Administrator of the 
Administration. The Administrator has been delegated authority under the 
Act by the Attorney General (28 CFR 0.100).
    (e) The term inspector means an officer or employee of the 
Administration authorized by the Administrator to make inspections under 
the Act.

[[Page 230]]

    (f) The term register and registration refer to registration 
required and permitted by sections 303 and 1008 of the Act (21 U.S.C. 
823 and 958).
    (g) Any term not defined in this part shall have the definition set 
forth in section 102 of the Act (21 U.S.C. 802) or part 1300 of this 
chapter.

[36 FR 7820, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973, 
as amended at 60 FR 32465, June 22, 1995; 60 FR 36334, July 14, 1995; 62 
FR 13969, Mar. 24, 1997]



Sec. 1316.03  Authority to make inspections.

    In carrying out his functions under the Act, the Administrator, 
through his inspectors, is authorized in accordance with sections 510 
and 1015 of the Act (21 U.S.C. 880 and 965) to enter controlled premises 
and conduct administrative inspections thereof, for the purpose of:
    (a) Inspecting, copying, and verifying the correctness of records, 
reports, or other documents required to be kept or made under the Act 
and regulations promulgated under the Act, including, but not limited 
to, inventory and other records required to be kept pursuant to part 
1304 of this chapter, order form records required to be kept pursuant to 
part 1305 of this chapter, prescription and distribution records 
required to be kept pursuant to part 1306 of this chapter, records of 
listed chemicals, tableting machines, and encapsulating machines 
required to be kept pursuant to part 1310 of this chapter, import/export 
records of listed chemicals required to be kept pursuant to part 1313 of 
this chapter, shipping records identifying the name of each carrier used 
and the date and quantity of each shipment, and storage records 
identifying the name of each warehouse used and the date and quantity of 
each storage.
    (b) Inspecting within reasonable limits and to a reasonable manner 
all pertinent equipment, finished and unfinished controlled substances, 
listed chemicals, and other substances or materials, containers, and 
labeling found at the controlled premises relating to this Act;
    (c) Making a physical inventory of all controlled substances and 
listed chemicals on-hand at the premises;
    (d) Collecting samples of controlled substances or listed chemicals 
(in the event any samples are collected during an inspection, the 
inspector shall issue a receipt for such samples on DEA Form 400 to the 
owner, operator, or agent in charge of the premises);
    (e) Checking of records and information on distribution of 
controlled substances or listed chemicals by the registrant or regulated 
person (i.e., has the distribution of controlled substances or listed 
chemicals increased markedly within the past year, and if so why);
    (f) Except as provided in Sec. 1316.04, all other things therein 
(including records, files, papers, processes, controls and facilities) 
appropriate for verification of the records, reports, documents referred 
to above or otherwise bearing on the provisions of the Act and the 
regulations thereunder.

[36 FR 7820, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973, 
and amended at 51 FR 5319, Feb. 13, 1986; 55 FR 50827, Dec. 11, 1990; 60 
FR 32465, June 22, 1995; 77 FR 4238, Jan. 27, 2012]



Sec. 1316.04  Exclusion from inspection.

    (a) Unless the owner, operator or agent in charge of the controlled 
premises so consents in writing, no inspection authorized by these 
regulations shall extend to:
    (1) Financial data:
    (2) Sales data other than shipping data; or
    (3) Pricing data.
    (b) [Reserved]



Sec. 1316.05  Entry.

    An inspection shall be carried out by an inspector. Any such 
inspector, upon (a) stating his purpose and (b) presenting to the owner, 
operator or agent in charge of the premises to be inspected (1) 
appropriate credentials, and (2) written notice of his inspection 
authority under Sec. 1316.06 of this chapter, and (c) receiving 
informed consent under Sec. 1316.08 or through the use of 
administrative warrant issued under Sec. Sec. 1316.09-1316.13, shall 
have the right to

[[Page 231]]

enter such premises and conduct inspections at reasonable times and in a 
reasonable manner.

[36 FR 7820, Apr. 24, 1971, as amended at 36 FR 13387, July 21, 1971. 
Redesignated at 38 FR 26609, Sept. 24, 1973; 62 FR 13970, Mar. 24, 1997]



Sec. 1316.06  Notice of inspection.

    The notice of inspection (DEA (or DNB) Form 82) shall contain:
    (a) The name and title of the owner, operator, or agent in charge of 
the controlled premises;
    (b) The controlled premises name;
    (c) The address of the controlled premises to be inspected;
    (d) The date and time of the inspection;
    (e) A statement that a notice of inspection is given pursuant to 
section 510 of the Act (21 U.S.C. 880);
    (f) A reproduction of the pertinent parts of section 510 of the Act; 
and
    (g) The signature of the inspector.



Sec. 1316.07  Requirement for administrative inspection warrant; 
exceptions.

    In all cases where an inspection is contemplated, an administrative 
inspection warrant is required pursuant to section 510 of the Act (21 
U.S.C. 880), except that such warrant shall not be required for 
establishments applying for initial registration under the Act, for the 
inspection of books and records pursuant to an administrative subpoena 
issued in accordance with section 506 of the Act (21 U.S.C. 876) nor for 
entries in administrative inspections (including seizures of property):
    (a) With the consent of the owner, operator, or agent in charge of 
the controlled premises as set forth in Sec. 1316.08;
    (b) In situations presenting imminent danger to health or safety;
    (c) In situations involving inspection of conveyances where there is 
reasonable cause to obtain a warrant;
    (d) In any other exceptional or emergency circumstance or time or 
opportunity to apply for a warrant is lacking; or
    (e) In any other situations where a warrant is not constitutionally 
required.



Sec. 1316.08  Consent to inspection.

    (a) An administrative inspection warrant shall not be required if 
informed consent is obtained from the owner, operator, or agent in 
charge of the controlled premises to be inspected.
    (b) Wherever possible, informed consent shall consist of a written 
statement signed by the owner, operator, or agent in charge of the 
premises to be inspected and witnessed by two persons. The written 
consent shall contain the following information:
    (1) That he (the owner, operator, or agent in charge of the 
premises) has been informed of his constitutional right not to have an 
administrative inspection made without an administrative inspection 
warrant;
    (2) That he has right to refuse to consent to such an inspection;
    (3) That anything of an incriminating nature which may be found may 
be seized and used against him in a criminal prosecution;
    (4) That he has been presented with a notice of inspection as set 
forth in Sec. 1316.06;
    (5) That the consent is given by him is voluntary and without 
threats of any kind; and
    (6) That he may withdraw his consent at any time during the course 
of inspection.
    (c) The written consent shall be produced in duplicate and be 
distributed as follows:
    (1) The original will be retained by the inspector; and
    (2) The duplicate will be given to the person inspected.

[36 FR 7820, Apr. 24, 1971, as amended at 37 FR 15924, Aug. 8, 1972. 
Redesignated at 38 FR 26609, Sept. 24, 1973]



Sec. 1316.09  Application for administrative inspection warrant.

    (a) An administrative inspection warrant application shall be 
submitted to any judge of the United States or of a State court of 
record, or any United States magistrate and shall contain the following 
information:
    (1) The name and address of the controlled premises to be inspected;
    (2) A statement of statutory authority for the administrative 
inspection warrant, and that the fact that the particular inspection in 
question is designed to insure compliance with the Act and the 
regulations promulgated thereunder;

[[Page 232]]

    (3) A statement relating to the nature and extent of the 
administrative inspection, including, where necessary, a request to 
seize specified items and/or to collect samples of finished or 
unfinished controlled substances or listed chemicals;
    (4) A statement that the establishment either:
    (i) Has not been previously inspected, or
    (ii) Was last inspected on a particular date.
    (b) The application shall be submitted under oath to an appropriate 
judge or magistrate.

[36 FR 7820, Apr. 24, 1971, as amended at 36 FR 13387, July 21, 1971. 
Redesignated at 38 FR 26609, Sept. 24, 1973; 60 FR 32466, June 22, 1995]



Sec. 1316.10  Administrative probable cause.

    If the judge or magistrate is satisfied that ``administrative 
probable cause,'' as defined in section 510(d)(1) of the Act (21 U.S.C. 
880(d)(1)) exists, he shall issue an administrative warrant. 
Administrative probable cause shall not mean criminal probable cause as 
defined by Federal statute or case law.



Sec. 1316.11  Execution of warrants.

    An administrative inspection warrant shall be executed and returned 
as required by, and any inventory or seizure made shall comply with the 
requirements of, section 510(d)(3) of the Act (21 U.S.C. 880(d)(3)). The 
inspection shall begin as soon as is practicable after the issuance of 
the administrative inspection warrant and shall be completed with 
reasonable promptness. The inspection shall be conducted during regular 
business hours and shall be completed in a reasonable manner.



Sec. 1316.12  Refusal to allow inspection with an administrative warrant.

    If a registrant or any person subject to the Act refuses to permit 
execution of an administrative warrant or impedes the inspector in the 
execution of that warrant, he shall be advised that such refusal or 
action constitutes a violation of section 402(a)(6) of the Act (21 
U.S.C. 842(a)(6)). If he persists and the circumstances warrant, he 
shall be arrested and the inspection shall commence or continue.

[36 FR 7820, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973, 
as amended at 62 FR 13970, Mar. 24, 1997]



Sec. 1316.13  Frequency of administrative inspections.

    Except where circumstances otherwise dictate, it is the intent of 
the Administration to inspect all manufacturers of controlled substances 
listed in Schedules I and II and distributors of controlled substances 
listed in Schedule I once each year. Distributors of controlled 
substances listed in Schedules II through V and manufacturers of 
controlled substances listed in Schedules III through V shall be 
inspected as circumstances may require, based in part on the 
registrant's history of compliance with the requirements of this chapter 
and maintenance of effective controls and procedures to guard against 
the diversion of controlled substances.

[62 FR 13969, Mar. 24, 1997]



        Subpart B_Protection of Researchers and Research Subjects

    Authority: 21 U.S.C. 830, 871(b).



Sec. 1316.21  Definitions.

    As used in this part, the following terms shall have the meanings 
specified:
    (a) The term investigative personnel includes managers, Diversion 
Investigators, attorneys, analysts and support personnel employed by the 
Drug Enforcement Administration who are involved in the processing, 
reviewing and analyzing of declarations and other relevant documents or 
data relative to regulated transactions or are involved in conducting 
investigations initiated pursuant to the receipt of such declarations, 
documents or data.
    (b) The term law enforcement personnel means Special Agents employed 
by the Drug Enforcement Administration who, in the course of their 
official duties, gain knowledge of information

[[Page 233]]

which is confidential under such section.

[54 FR 31670, Aug. 1, 1989]



Sec. 1316.22  Exemption.

    (a) Any person who is aggrieved by a disclosure of information in 
violation of subsection (c)(1) of Section 310 of the Controlled 
Substances Act (21 U.S.C. 830) may bring a civil action against the 
violator for appropriate relief.
    (b) Notwithstanding the provision of paragraph (a), a civil action 
may not be brought under such paragraph against investigative or law 
enforcement personnel of the Drug Enforcement Administration.

[54 FR 31670, Aug. 1, 1989]



Sec. 1316.23  Confidentiality of identity of research subjects.

    (a) Any person conducting a bona fide research project directly 
related to the enforcement of the laws under the jurisdiction of the 
Attorney General concerning drugs or other substances which are or may 
be subject to control under the Controlled Substances Act (84 Stat. 
1242; 21 U.S.C. 801) who intends to maintain the confidentiality of the 
identity of those persons who are the subjects of such research may 
petition the Administrator of the Drug Enforcement Administration for a 
grant of confidentiality: Providing, That:
    (1) The Attorney General is authorized to carry out such research 
under the provisions of Section 502(a) (2-6) of the Controlled 
Substances Act of 1970 (21 U.S.C. 872(a) (2-6)); and the research is 
being conducted with funds provided in whole or part by the Department 
of Justice; or
    (2) The research is of a nature that the Attorney General would be 
authorized to carry out under the provisions of Section 502(a) (2-6) of 
the Controlled Substances Act (21 U.S.C. 872(a) (2-6), and is being 
conducted with funds provided from sources outside the Department of 
Justice.
    (b) All petitions for Grants of Confidentiality shall be addressed 
to the Administrator, Drug Enforcement Administration (see the Table of 
DEA Mailing Addresses in Sec. 1321.01 of this chapter for the current 
mailing address):
    (1) A statement as to whether the research protocol requires the 
manufacture, production, import, export, distribution, dispensing, 
administration, or possession of controlled substances, and if so the 
researcher's registration number or a statement that an application for 
such registration has been submitted to DEA;
    (2) The location of the research project;
    (3) The qualifications of the principal investigator;
    (4) A general description of the research or a copy of the research 
protocol;
    (5) The source of funding for the research project;
    (6) A statement as to the risks posed to the research subjects by 
the research procedures and what protection will be afforded to the 
research subjects;
    (7) A statement as to the risks posed to society in general by the 
research procedures and what measures will be taken to protect the 
interests of society;
    (8) A specific request to withhold the names and/or any other 
identifying characteristics of the research subjects; and
    (9) Statements establishing that a grant of confidentiality is 
necessary to the successful completion of the research project.
    (c) The grant of confidentiality of identity of research subjects 
shall consist of a letter issued by the Administrator, which shall 
include:
    (1) The researcher's name and address.
    (2) The researcher's registration number, if applicable.
    (3) The title and purpose of the research.
    (4) The location of the research project.
    (5) An authorization for all persons engaged in the research to 
withhold the names and identifying characteristics of persons who are 
the subjects of such research, stating that persons who obtain this 
authorization may not be compelled in any Federal, State, or local 
civil, criminal, administrative, legislative, or other proceeding to 
identify the subjects of such research for which this authorization was 
obtained.

[[Page 234]]

    (6) The limits of this authorization, if any.
    (7) A statement to the effect that the grant of confidentiality of 
identity of research subjects shall be perpetual but shall pertain only 
to the subjects of the research described in the research protocol, the 
description of the research submitted to DEA, or as otherwise 
established by DEA.
    (d) Within 30 days of the date of completion of the research 
project, the researcher shall so notify the Administrator. The 
Administrator shall issue another letter including the information 
required in paragraph (c) of this section and stating the starting and 
finishing dates of the research for which the confidentiality of 
identity of research subjects was granted; upon receipt of this letter, 
the research shall return the original letter of exemption.

[42 FR 54946, Oct. 12, 1977. Redesignated at 54 FR 31670, Aug. 1, 1989, 
as amended at 62 FR 13970, Mar. 24, 1997; 75 FR 10685, Mar. 9, 2010]



Sec. 1316.24  Exemption from prosecution for researchers.

    (a) Upon registration of an individual to engage in research in 
controlled substances under the Controlled Substances Act (84 Stat. 
1242; 21 U.S.C. 801), the Administrator of the Drug Enforcement 
Administration, on his own motion or upon request in writing from the 
Secretary or from the researcher or researching practitioner, may exempt 
the registrant when acting within the scope of his registration, from 
prosecution under Federal, State, or local laws for offenses relating to 
possession, distribution or dispensing of those controlled substances 
within the scope of his exemption. However, this exemption does not 
diminish any requirement of compliance with the Federal Food, Drug and 
Cosmetic Act (21 U.S.C. 301).
    (b) All petitions for Grants of Exemption from Prosecution for the 
Researcher shall be addressed to the Administrator, Drug Enforcement 
Administration, (see the Table of DEA Mailing Addresses in Sec. 1321.01 
of this chapter for the current mailing address) and shall contain the 
following:
    (1) The researcher's registration number if any, for the project;
    (2) The location of the research project;
    (3) The qualifications of the principal investigator;
    (4) A general description of the research or a copy of the research 
protocol;
    (5) The source of funding for the research project;
    (6) A statement as to the risks posed to the research subjects by 
the research procedures and what protection will be afforded to the 
research subjects;
    (7) A statement as to the risks posed to society in general by the 
research procedures and what measures will be taken to protect the 
interests of society;
    (8) A specific request for exemption from prosecution by Federal, 
State, or local authorities for offenses related to the possession, 
distribution, and dispensing of controlled substances in accord with the 
procedures described in the research protocol;
    (9) A statement establishing that a grant of exemption from 
prosecution is necessary to the successful completion of the research 
project.
    (c) Any researcher or practitioner proposing to engage in research 
requesting both exemption from prosecution and confidentiality of 
identity of research subjects may submit a single petition incorporating 
the information required in Sec. Sec. 1316.23(b) and 1316.24(b).
    (d) The exemption shall consist of a letter issued by the 
Administrator, which shall include:
    (1) The researcher's name and address;
    (2) The researcher's registration number for the research project;
    (3) The location of the research project;
    (4) A concise statement of the scope of the researcher's 
registration;
    (5) Any limits of the exemption; and
    (6) A statement that the exemption shall apply to all acts done in 
the scope of the exemption while the exemption is in effect. The 
exemption shall remain in effect until completion of the research 
project or until the registration of the researcher is either revoked or 
suspended or his renewal of registration is denied. However, the 
protection afforded by the grant of exemption

[[Page 235]]

from prosecution during the research period shall be perpetual.
    (e) Within 30 days of the date of completion of the research 
project, the researcher shall so notify the Administrator. The 
Administrator shall issue another letter including the information 
required in paragraph (d) of this section and stating the date of which 
the period of exemption concluded; upon receipt of this letter the 
researcher shall return the original letter of exemption.

[42 FR 54946, Oct. 12, 1977. Redesignated at 54 FR 31670, Aug. 1, 1989, 
as amended at 62 FR 13970, Mar. 24, 1997; 75 FR 10685, Mar. 9, 2010]



                    Subpart C_Enforcement Proceedings

    Authority: 21 U.S.C. 871(b), 883.



Sec. 1316.31  Authority for enforcement proceeding.

    A hearing may be ordered or granted by any Special Agent in Charge 
of the Drug Enforcement Administration, at his discretion, to permit any 
person against whom criminal and/or civil action is contemplated under 
the Controlled Substances Act (84 Stat. 1242; 21 U.S.C. 801) or the 
Controlled Substances Import and Export Act (84 Stat. 1285; 21 U.S.C. 
951) an opportunity to present his views and his proposals for bringing 
his alleged violations into compliance with the law. Such hearing will 
also permit him to show cause why prosecution should not be instituted, 
or to present his views on the contemplated proceeding.

[36 FR 7820, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973, 
and amended at 47 FR 41735, Sept. 22, 1982]



Sec. 1316.32  Notice of proceeding; time and place.

    Appropriate notice designating the time and place for the hearing 
shall be given to the person. Upon request, timely and properly made, by 
the person to whom notice has been given, the time or place of the 
hearing, or both, may be changed if the request states reasonable 
grounds for such change. Such request shall be addressed to the Special 
Agent in Charge who issued the notice.

[36 FR 7820, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973, 
and amended at 47 FR 41735, Sept. 22, 1982]



Sec. 1316.33  Conduct of proceeding.

    Presentation of views at a hearing under this subpart shall be 
private and informal. The views presented shall be confined to matters 
relevant to bringing violations into compliance with the Act or to other 
contemplated proceedings under the Act. These views may be presented 
orally or in writing by the person to whom the notice was given, or by 
his authorized representative.



Sec. 1316.34  Records of proceeding.

    A formal record, either verbatim or summarized, of the hearing may 
be made at the discretion of the Special Agent in Charge. If a verbatim 
record is to be made, the person attending the hearing will be so 
advised prior to the start of the hearing.

[37 FR 15924, Aug. 8, 1972. Redesignated at 38 FR 26609, Sept. 24, 1973, 
and amended at 47 FR 41735, Sept. 22, 1982]



                    Subpart D_Administrative Hearings

    Authority: 21 U.S.C. 811, 812, 871(b), 875, 958(d), 965.



Sec. 1316.41  Scope of subpart D.

    Procedures in any administrative hearing held under the Act are 
governed generally by the rule making and/or adjudication procedures set 
forth in the Administrative Procedure Act (5 U.S.C. 551-559) and 
specifically by the procedures set forth in this subpart, except where 
more specific regulations (set forth in Sec. Sec. 1301.51-1301.57, 
Sec. Sec. 1303.31-1303.37, Sec. Sec. 1308.41-1308.51, Sec. Sec. 
1311.51-1311.53, Sec. Sec. 1312.41-1312.47, Sec. Sec. 1313.51-1313.57, 
or Sec. Sec. 1315.50-1315.62) apply.

[73 FR 73556, Dec. 3, 2008]



Sec. 1316.42  Definitions.

    As used in this subpart, the following terms shall have the meanings 
specified:

[[Page 236]]

    (a) The term Act means the Controlled Substances Act (84 Stat. 1242; 
21 U.S.C. 801) and/or the Controlled Substances Import and Export Act 
(84 Stat. 1285; 21 U.S.C. 951).
    (b) The term Administrator means the Administrator of the 
Administration. The Administrator has been delegated authority under the 
Act by the Attorney General (28 CFR 0.100).
    (c) The term hearing means any hearing held pursuant to the Act.
    (d) The term Hearing Clerk means the hearing clerk of the 
Administration.
    (e) The term person includes an individual, corporation, government 
or governmental subdivision or agency, business trust, partnership, 
association or other legal entity.
    (f) The term presiding officer means an administrative law judge 
qualified and appointed as provided in the Administrative Procedure Act 
(5 U.S.C. 556).
    (g) The term proceeding means all actions involving a hearing, 
commencing with the publication by the Administrator of the notice of 
proposed rulemaking or the issuance of an order to show cause.
    (h) Any term not defined in this part shall have the definition set 
forth in section 102 of the Act (21 U.S.C. 802) or part 1300 of this 
chapter.

[36 FR 7820, Apr. 24, 1971, as amended at 38 FR 757, Jan. 4, 1973. 
Redesignated at 38 FR 26609, Sept. 24, 1973, as amended at 62 FR 13969, 
Mar. 24, 1997; 77 FR 4238, Jan. 27, 2012]



Sec. 1316.43  Information; special instructions.

    Information regarding procedure under these rules and instructions 
supplementing these rules in special instances will be furnished by the 
Hearing Clerk upon request.



Sec. 1316.44  Waiver or modification of rules.

    The Administrator or the presiding officer (with respect to matters 
pending before him) may modify or waive any rule in this subpart by 
notice in advance of the hearing, if he determines that no party in the 
hearing will be unduly prejudiced and the ends of justice will thereby 
be served. Such notice of modification or waiver shall be made a part of 
the record of the hearing.



Sec. 1316.45  Filings; address; hours.

    Documents required or permitted to be filed in, and correspondence 
relating to, hearings governed by the regulations in this chapter shall 
be filed with the Hearing Clerk, Drug Enforcement Administration. See 
the Table of DEA Mailing Addresses in Sec. 1321.01 of this chapter for 
the current mailing address. This office is open Monday through Friday 
from 8:30 a.m. to 5 p.m. eastern standard or daylight saving time, 
whichever is effective in the District of Columbia at the time, except 
on national legal holidays. Documents shall be dated and deemed filed 
upon receipt by the Hearing Clerk.

[75 FR 10685, Mar. 9, 2010]



Sec. 1316.46  Inspection of record.

    (a) The record bearing on any proceeding, except for material 
described in subsection (b) of this section, shall be available for 
inspection and copying by any person entitled to participate in such 
proceeding, during office hours in the office of the Hearing Clerk, Drug 
Enforcement Administration. See the Table of DEA Mailing Addresses in 
Sec. 1321.01 of this chapter for the current mailing address.
    (b) The following material shall not be available for inspection as 
part of the record:
    (1) A research protocol filed with an application for registration 
to conduct research with controlled substances listed in Schedule I, 
pursuant to Sec. 1301.32 (a)(6) of this chapter, if the applicant 
requests that the protocol be kept confidential;
    (2) An outline of a production or manufacturing process filed with 
an application for registration to manufacture a new narcotic controlled 
substance, pursuant to Sec. 1301.33 of this chapter, if the applicant 
requests that the outline be kept confidential;
    (3) Any confidential or trade secret information disclosed in 
conjunction with an application for registration, or in reports filed 
while registered, or acquired in the course of an investigation, 
entitled to protection under subsection 402(a) (8) of the Act (21 U.S.C.

[[Page 237]]

842(a) (8)) or any other law restricting public disclosure of 
information; and
    (4) Any material contained in any investigatory report, memorandum, 
or file, or case report compiled by the Administration.

[36 FR 7820, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973, 
as amended at 62 FR 13970, Mar. 24, 1997; 75 FR 10645, Mar. 9, 2010]



Sec. 1316.47  Request for hearing.

    (a) Any person entitled to a hearing and desiring a hearing shall, 
within the period permitted for filing, file a request for a hearing in 
the following form (see the Table of DEA Mailing Addresses in Sec. 
1321.01 of this chapter for the current mailing address):
--------------------(Date)

Administrator, Drug Enforcement Administration, Attention: DEA Federal 
Register Representative.

    Dear Sir: The undersigned ------------ (Name of person) hereby 
requests a hearing in the matter of: ---------------- (Identification of 
the proceeding).
    (A) (State with particularity the interest of the person in the 
proceeding.)
    (B) (State with particularity the objections or issues, if any, 
concerning which the person desires to be heard.)
    (C) (State briefly the position of the person with regard to the 
particular objections or issues.)
    All notices to be sent pursuant to the proceeding should be 
addressed to:
-------------------- (Name)
-------------------- (Street address)
-------------------- (City and State)

    Respectfully yours,
-------------------- (Signature of person)

    (b) The Administrative Law Judge, upon request and showing of good 
cause, may grant a reasonable extension of the time allowed for response 
to an Order to Show Cause.

[36 FR 7820, Apr. 24, 1971, as amended at 36 FR 13387, July 21, 1971. 
Redesignated at 38 FR 26609, Sept. 24, 1973]

    Editorial Note: For Federal Register citations affecting Sec. 
1316.47, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and at www.fdsys.gov.



Sec. 1316.48  Notice of appearance.

    Any person entitled to a hearing and desiring to appear in any 
hearing, shall, if he has not filed a request for hearing, file within 
the time specified in the notice of proposed rulemaking, a written 
notice of appearance in the following form (see the Table of DEA Mailing 
Addresses in Sec. 1321.01 of this chapter for the current mailing 
address):
-------------------- (Date)

Administrator, Drug Enforcement Administration

-------------------- (Mailing Address), Attention: Federal Register 
Representative

    Dear Sir: Please take notice that ---------------- (Name of person) 
will appear in the matter of: ---------------- (Identification of the 
proceeding).
    (A) (State with particularity the interest of the person in the 
proceeding.)
    (B) (State with particularity the objections or issues, if any, 
concerning which the person desires to be heard.)
    (C) (State briefly the position of the person with regard to the 
particular objections or issues.)
    All notices to be sent pursuant to this appearance should be 
addressed to:
-------------------- (Name)
-------------------- (Street address)
-------------------- (City and State)

    Respectfully yours,
-------------------- (Signature of person)

[75 FR 10685, Mar. 9, 2010]



Sec. 1316.49  Waiver of hearing.

    Any person entitled to a hearing may, within the period permitted 
for filing a request for hearing or notice of appearance, waiver of an 
opportunity for a hearing, together with a written statement regarding 
his position on the matters of fact and law involved in such hearing. 
Such statement, if admissible, shall be made a part of the record and 
shall be considered in light of the lack of opportunity for cross-
examination in determining the weight to be attached to matters of fact 
asserted therein.



Sec. 1316.50  Appearance; representation; authorization.

    Any person entitled to appear in a hearing may appear in person or 
by a representative in any proceeding or hearing and may be heard with 
respect to matters relevant to the issues under consideration. A 
representative must either be an employee of the person or an attorney 
at law who is a member of the bar, in good standing, of any State, 
territory, or the District of Columbia, and admitted to practice before 
the

[[Page 238]]

highest court of that jurisdiction. Any representative may be required 
by the Administrator or the presiding officer to present a notarized 
power of attorney showing his authority to act in such representative 
capacity and/or an affidavit or certificate of admission to practice.

[36 FR 7820, Apr. 24, 1971, as amended at 36 FR 13387, July 21, 1971. 
Redesignated at 38 FR 26609, Sept. 24, 1973]



Sec. 1316.51  Conduct of hearing and parties; ex parte communications.

    (a) Hearings shall be conducted in an informal but orderly manner in 
accordance with law and the directions of the presiding officer.
    (b) Participants in any hearing and their representatives, whether 
or not members of the bar, shall conduct themselves in accordance with 
judicial standards of practice and ethics and the directions of the 
presiding officer. Refusal to comply with this section shall constitute 
grounds for immediate exclusion from any hearing.
    (c) If any official of the Administration is contacted by any 
individual in private or public life concerning any substantive matter 
which is the subject of any hearing, at any time after the date on which 
the proceedings commence, the official who is contacted shall prepare a 
memorandum setting forth the substance of the conversation and shall 
file this memorandum in the appropriate public docket file. The 
presiding officer and employees of the Administration shall comply with 
the requirements of 5 U.S.C. 554(d) regarding ex parte communications 
and participation in any hearing.



Sec. 1316.52  Presiding officer.

    A presiding officer, designated by the Administrator, shall preside 
over all hearings. The functions of the presiding officer shall commence 
upon his designation and terminate upon the certification of the record 
to the Administrator. The presiding officer shall have the duty to 
conduct a fair hearing, to take all necessary action to avoid delay, and 
to maintain order. He shall have all powers necessary to these ends, 
including (but not limited to) the power to:
    (a) Arrange and change the date, time, and place of hearings (other 
than the time and place prescribed in Sec. 1301.56) and prehearing 
conferences and issue notice thereof.
    (b) Hold conferences to settle, simplify, or determine the issues in 
a hearing, or to consider other matters that may aid in the expeditious 
disposition of the hearing.
    (c) Require parties to state their position in writing with respect 
to the various issues in the hearing and to exchange such statements 
with all other parties.
    (d) Sign and issue subpoenas to compel the attendance of witnesses 
and the production of documents and materials to the extent necessary to 
conduct administrative hearings pending before him.
    (e) Examine witnesses and direct witnesses to testify.
    (f) Receive, rule on, exclude, or limit evidence.
    (g) Rule on procedural items pending before him.
    (h) Take any action permitted to the presiding officer as authorized 
by this part or by the provisions of the Administrative Procedure Act (5 
U.S.C. 551-559).

[36 FR 7820, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973, 
and amended at 42 FR 57457, Nov. 3, 1977; 62 FR 13970, Mar. 24, 1997]



Sec. 1316.53  Time and place of hearing.

    The hearing will commence at the place and time designated in the 
notice of hearing published in the Federal Register but thereafter it 
may be moved to a different place and may be continued from day to day 
or recessed to a later day without notice other than announcement 
thereof by the presiding officer at the hearing.



Sec. 1316.54  Prehearing conference.

    The presiding officer on his own motion, or on the motion of any 
party for good cause shown, may direct all parties to appear at a 
specified time and place for a conference for:
    (a) The simplification of the issues.
    (b) The possibility of obtaining stipulations, admission of facts, 
and documents.

[[Page 239]]

    (c) The possibility of limiting the number of expert witnesses.
    (d) The identification and, if practicable, the scheduling of all 
witnesses to be called.
    (e) The advance submission at the prehearing conference of all 
documentary evidence and affidavits to be marked for identification.
    (f) Such other matters as may aid in the expeditious disposition of 
the hearing.



Sec. 1316.55  Prehearing ruling.

    The presiding officer may have the prehearing conference reported 
verbatim and shall make a ruling reciting the action taken at the 
conference, the agreements made by the parties, the schedule of 
witnesses, and a statement of the issues for hearing. Such ruling shall 
control the subsequent course of the hearing unless modified by a 
subsequent ruling.



Sec. 1316.56  Burden of proof.

    At any hearing, the proponent for the issuance, amendment, or repeal 
of any rule shall have the burden of proof.



Sec. 1316.57  Submission of documentary evidence and affidavits and
identification of witnesses subsequent to prehearing conference.

    All documentary evidence and affidavits not submitted and all 
witnesses not identified at the prehearing conference shall be submitted 
or identified to the presiding officer as soon as possible, with a 
showing that the offering party had good cause for failing to so submit 
or identify at the prehearing conference. If the presiding officer 
determines that good cause does exist, the documents or affidavits shall 
be submitted or witnesses identified to all parties sufficiently in 
advance of the offer of such documents or affidavits or witnesses at the 
hearing to avoid prejudice or surprise to the other parties. If the 
presiding officer determines that good cause does not exist, he may 
refuse to admit as evidence such documents or affidavits or the 
testimony of such witnesses.



Sec. 1316.58  Summary of testimony; affidavits.

    (a) The presiding officer may direct that summaries of the direct 
testimony of witnesses be prepared in writing and served on all parties 
in advance of the hearing. Witnesses will not be permitted to read 
summaries of their testimony into the record and all witnesses shall be 
available for cross-examination. Each witness shall, before proceeding 
to testify, be sworn or make affirmation.
    (b) Affidavits submitted at the prehearing conference or pursuant to 
Sec. 1316.57 with good cause may be examined by all parties and 
opposing affidavits may be submitted to the presiding officer within a 
period of time fixed by him. Affidavits admitted into evidence shall be 
considered in light of the lack of opportunity for cross-examination in 
determining the weight to be attached to statements made therein.

[36 FR 7820, Apr. 24, 1971, as amended at 36 FR 13387, July 21, 1971. 
Redesignated at 38 FR 26609, Sept. 24, 1973]



Sec. 1316.59  Submission and receipt of evidence.

    (a) The presiding officer shall admit only evidence that is 
competent, relevant, material and not unduly repetitious.
    (b) Opinion testimony shall be admitted when the presiding officer 
is satisfied that the witness is properly qualified.
    (c) The authenticity of all documents submitted in advance shall be 
deemed admitted unless written objection thereto is filed with the 
presiding officer, except that a party will be permitted to challenge 
such authenticity at a later time upon a showing of good cause for 
failure to have filed such written objection.
    (d) Samples, if otherwise admissible into evidence, may be displayed 
at the hearing and may be described for purposes of the record, or may 
be admitted in evidence as exhibits.
    (e) Where official notice is taken or is to be taken of a material 
fact not appearing in the evidence of record, any party, on timely 
request, shall be afforded opportunity to controvert such fact.

[[Page 240]]

    (f) The presiding officer shall file as exhibits copies of the 
following documents:
    (1) The order to show cause or notice of hearing;
    (2) Any notice of waiver or modification of rules made pursuant to 
Sec. 1316.44 or otherwise;
    (3) Any waiver of hearing (together with any statement filed 
therewith) filed pursuant to Sec. 1316.49 or otherwise;
    (4) The prehearing ruling, if any, made pursuant to Sec. 1316.55;
    (5) Any other document necessary to show the basis for the hearing.



Sec. 1316.60  Objections; offer of proof.

    If any party in the hearing objects to the admission or rejection of 
any evidence or to other limitation of the scope of any examination or 
cross-examination, he shall state briefly the grounds for such objection 
without extended argument or debate thereon except as permitted by the 
presiding officer. A ruling of the presiding officer on any such 
objection shall be a part of the transcript together with such offer of 
proof as has been made if a proper foundation has been laid for its 
admission. An offer of proof made in connection with an objection taken 
to any ruling of the presiding officer rejecting or excluding proffered 
oral testimony shall consist of a statement of the substance of the 
evidence which the party contends would be adduced by such testimony; 
and, if the excluded evidence consists of evidence in documentary or 
written form a copy of such evidence shall be marked for identification 
and shall accompany the records as the offer of proof.



Sec. 1316.61  Exceptions to rulings.

    Exceptions to rulings of the presiding officer are unnecessary. It 
is sufficient that a party, at the time the ruling of the presiding 
officer is sought, makes known the action that he desires the presiding 
officer to take, or his objection to an action taken, and his grounds 
therefor.



Sec. 1316.62  Appeal from ruling of presiding officer.

    Rulings of the presiding officer may not be appealed to the 
Administrator prior to his consideration of the entire hearing, except 
with the consent of the presiding officer and where he certifies on the 
record or in writing that the allowance of an interlocutory appeal is 
clearly necessary to prevent exceptional delay, expense, or prejudice to 
any party or substantial detriment to the public interest. If an appeal 
is allowed, any party in the hearing may file a brief in quintuplicate 
with the Administrator within such period that the presiding officer 
directs. No oral argument will be heard unless the Administrator directs 
otherwise.



Sec. 1316.63  Official transcript; index; corrections.

    (a) Testimony given at a hearing shall be reported verbatim. The 
Administration will make provision for a stenographic record of the 
testimony and for such copies of the transcript thereof as it requires 
for its own purpose.
    (b) At the close of the hearing, the presiding officer shall afford 
the parties and witnesses time (not longer than 30 days, except in 
unusual cases) in which to submit written proposed corrections of the 
transcript, pointing out errors that may have been made in transcribing 
the testimony. The presiding officer shall promptly thereafter order 
such corrections made as in his judgment are required to make the 
transcript conform to the testimony.

[36 FR 7820, Apr. 24, 1971, as amended at 36 FR 13387, July 21, 1971. 
Redesignated at 38 FR 26609, Sept. 24, 1973, and amended at 50 FR 2046, 
Jan. 15, 1985]



Sec. 1316.64  Proposed findings of fact and conclusions of law.

    Any party in the hearing may file in quintuplicate proposed findings 
of fact and conclusions of law within the time fixed by the presiding 
officer. Any party so filing shall also serve one copy of his proposed 
findings and conclusion upon each other party in the hearing. The party 
shall include a statement of supporting reasons for the proposed 
findings and conclusions, together with evidence of record (including 
specific and complete citations of the pages of the transcript and 
exhibits) and citations of authorities relied upon.

[[Page 241]]



Sec. 1316.65  Report and record.

    (a) As soon as practicable after the time for the parties to file 
proposed findings of fact and conclusions of law has expired, the 
presiding officer shall prepare a report containing the following:
    (1) His recommended rulings on the proposed findings of fact and 
conclusions of law;
    (2) His recommended findings of fact and conclusions of law, with 
the reasons therefore; and
    (3) His recommended decision.
    (b) The presiding officer shall serve a copy of his report upon each 
party in the hearing. The report shall be considered to have been served 
when it is mailed to such party or its attorney of record.
    (c) Not less than twenty-five days after the date on which he caused 
copies of his report to be served upon the parties, the presiding 
officer shall certify to the Administrator the record, which shall 
contain the transcript of testimony, exhibits, the findings of fact and 
conclusions of law proposed by the parties, the presiding officer's 
report, and any exceptions thereto which may have been filed by the 
parties.

[36 FR 7778, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973 
and amended at 44 FR 55332, Sept. 26, 1979]



Sec. 1316.66  Exceptions.

    (a) Within twenty days after the date upon which a party is served a 
copy of the report of the presiding officer, such party may file with 
the Hearing Clerk, Office of the Administrative Law Judge, exceptions to 
the recommended decision, findings of fact and conclusions of law 
contained in the report. The party shall include a statement of 
supporting reasons for such exceptions, together with evidence of record 
(including specific and complete citations of the pages of the 
transcript and exhibits) and citations of the authorities relied upon.
    (b) The Hearing Clerk shall cause such filings to become part of the 
record of the proceeding.
    (c) The Administrative Law Judge may, upon the request of any party 
to a proceeding, grant time beyond the twenty days provided in paragraph 
(a) of this section for the filing of a response to the exceptions filed 
by another party if he determines that no party in the hearing will be 
unduly prejudiced and that the ends of justice will be served thereby. 
Provided however, that each party shall be entitled to only one filing 
under this section; that is, either a set of exceptions or a response 
thereto.

[44 FR 55332, Sept. 26, 1979]



Sec. 1316.67  Final order.

    As soon as practicable after the presiding officer has certified the 
record to the Administrator, the Administrator shall cause to be 
published in the Federal Register his final order in the proceeding, 
which shall set forth the final rule and the findings of fact and 
conclusions of law upon which the rule is based. This order shall 
specify the date on which it shall take effect, which date shall not be 
less than 30 days from the date of publication in the Federal Register 
unless the Administrator finds that the public interest in the matter 
necessitates an earlier effective date, in which event the Administrator 
shall specify in the order his findings as to the conditions which led 
him to conclude that an earlier effective date was required.

[44 FR 42179, July 19, 1979, as amended at 44 FR 55332, Sept. 26, 1979]



Sec. 1316.68  Copies of petitions for judicial review.

    Copies of petitions for judicial review, filed pursuant to section 
507 of the Act (21 U.S.C. 877) shall be delivered to and served upon the 
Administrator in quintuplicate. The Administrator shall certify the 
record of the hearing and shall file the certified record in the 
appropriate U.S. Court of Appeals.

[36 FR 7820, Apr. 24, 1971. Redesignated at 44 FR 42179, July 19, 1979]



PART 1321_DEA MAILING ADDRESSES--Table of Contents



Sec.
1321.01 DEA mailing addresses.

    Authority: 21 U.S.C. 871(b).

[[Page 242]]


    Source: 75 FR 10685, Mar. 9, 2010, unless otherwise noted.



Sec. 1321.01  DEA mailing addresses.

    The following table provides information regarding mailing addresses 
to be used when sending specified correspondence to the Drug Enforcement 
Administration.

                     Table of DEA Mailing Addresses
------------------------------------------------------------------------
 Code of Federal Regulations Section--Topic      DEA Mailing address
------------------------------------------------------------------------
                            DEA Administrator
------------------------------------------------------------------------
1308.43(b)--Petition to initiate             Drug Enforcement
 proceedings for rulemaking.                  Administration, Attn:
316.23(b)--Petition for grant of              Administrator, 8701
 confidentiality for research subjects..      Morrissette Drive,
1316.24(b)--Petition for exemption from       Springfield, VA 22152.
 prosecution for researchers..
1316.48--Notice of appearance.
------------------------------------------------------------------------
                     DEA Office of Diversion Control
------------------------------------------------------------------------
1301.52(c)--Controlled substances            Drug Enforcement
 registration return for cancellation.        Administration, Attn:
1307.03--Exception request filing..........   Office of Diversion
1307.22--Disposal of controlled substances    Control/OD, 8701
 by the Administration delivery               Morrissette Drive,
 application..                                Springfield, VA 22152.
1308.21(a)--Exclusion of nonnarcotic
 substance.
1308.23(b)--Exemption for chemical
 preparations.
1308.25(a)--Exclusion of veterinary
 anabolic steroid implant product
 application.
1308.31(a)--Exemption of a nonnarcotic
 prescription product application.
1308.33(b)--Exemption of certain anabolic
 steroid products application.
1310.13(b)--Exemption for chemical
 preparations.
1310.21(b)--Sale by Federal departments or
 agencies of chemicals which could be used
 to manufacture controlled substances
 certification request.
------------------------------------------------------------------------
                         DEA Regulatory Section
------------------------------------------------------------------------
1301.71(d)--Security system compliance       Drug Enforcement
 review for controlled substances.            Administration, Attn:
1309.71(c)--Security system compliance        Regulatory Section/ODG,
 review for List I chemicals..                8701 Morrissette Drive,
                                              Springfield, VA 22152
------------------------------------------------------------------------
                         DEA Import/Export Unit
------------------------------------------------------------------------
1310.05(c)--Importer/exporter of tableting   Drug Enforcement
 or encapsulation machines reporting.         Administration, Attn:
1310.05(e)(1)--Reporting by persons           Import/Export Unit/ODGI,
 required to keep records and file reports    8701 Morrissette Drive,
 regarding List I chemicals..                 Springfield, VA 22152.
1310.05(e)(2)--Request to submit List I
 chemicals reports in electronic form.
1310.06(g)--Report of declared exports of
 machines refused, rejected, or returned.
1312.12(a)--Application for import permit
 (DEA Form 357).
1312.16(b)--Return unused import permits.
1312.18(b)--Import declaration (DEA Form
 236) submission.
1312.19(b)--DEA Form 236 copy 4 filing.
1312.22(a)--Application for export permit
 (DEA Form 161).
1312.22(d)(8)--Request for return of
 unacceptable or undeliverable exported
 controlled substances.
1312.24(a)--DEA Form 161 copy 2 filing.
1312.27(a)--Special controlled substances
 export invoice (DEA Form 236) filing.
1312.27(b)(5)(iv)--Request for reexport.
1312.28(d)--Distribution of special
 controlled substances invoice (DEA Form
 236) copy 4.
1312.31(b)--Controlled substances
 transshipment permit application.
1312.32(a)--Advanced notice of importation
 for transshipment or transfer of
 controlled substances.
1313.12(b)--Authorization to import listed
 chemicals (DEA Form 486).
1313.12(e)--Quarterly reports of listed
 chemicals importation.
1313.21(b)--Authorization to export listed
 chemicals (DEA Form 486).
1313.21(e)--Quarterly reports of listed
 chemicals exportation.
1313.22(e)--Written notice of declared
 exports of listed chemicals refused,
 rejected or undeliverable.
1313.31(b)--Advanced notice of importation
 for transshipment or transfer of listed
 chemicals.
1313.32(b)(1)--International transaction
 authorization (DEA Form 486).
1314.110(a)(1)--Reports for mail-order
 sales.
1314.110(a)(2)--Request to submit mail-
 order sales reports in electronic form.
------------------------------------------------------------------------

[[Page 243]]

 
                 DEA Drug & Chemical Evaluation Section
------------------------------------------------------------------------
1303.12(b)--Application for controlled       Drug Enforcement
 substances procurement quota (DEA Form       Administration, Attn: Drug
 250) filing and request.                     & Chemical Evaluation
1303.12(d)--Controlled substances quota       Section/ODE, 8701
 adjustment request..                         Morrissette Drive,
                                              Springfield, VA 22152.
1303.22--Application for individual
 manufacturing quota (DEA Form 189) filing
 and request for schedule I or II
 controlled substances.
1304.31(a)--Manufacturers importing
 narcotic raw material report submission.
1304.32(a)--Manufacturers importing coca
 leaves report submission.
1308.24(d)--Exempt narcotic chemical
 preparations importer/exporter reporting.
1308.24(i)--Exempted chemical preparations
 listing.
1308.26(a)--Excluded veterinary anabolic
 steroid implant products listing.
1308.32--Exempted prescription products
 listing.
1308.34--Exempted anabolic steroid products
 listing.
1310.05(d)--Bulk manufacturer of listed
 chemicals reporting.
1315.22--Application for individual
 manufacturing quota for ephedrine,
 pseudoephedrine, phenylpropanolamine (DEA
 Form 189) filing and request.
1315.32(e)--Application for procurement
 quota for ephedrine, pseudoephedrine,
 phenylpropanolamine (DEA Form 250) filing
 and request.
1315.32(g)--Procurement quota adjustment
 request for ephedrine, pseudoephedrine,
 phenylpropanolamine.
1315.34(d)--Application for import quota
 for ephedrine, pseudoephedrine,
 phenylpropanolamine (DEA Form 488) request
 and filing.
1315.36(b)--Request import quota increase
 for ephedrine, pseudoephedrine, or
 phenylpropanolamine.
------------------------------------------------------------------------
                             DEA ARCOS Unit
------------------------------------------------------------------------
1304.04(d)--ARCOS separate central           Drug Enforcement
 reporting identifier request.                Administration, Attn:
1304.33(a)--Reports to ARCOS...............   ARCOS Unit/ODPT, P.O. Box
                                              2520, Springfield, VA
                                              22152-2520, OR Drug
                                              Enforcement
                                              Administration, Attn:
                                              ARCOS Unit, 8701
                                              Morrissette Drive,
                                              Springfield, VA 22152.
------------------------------------------------------------------------
                        DEA Registration Section
------------------------------------------------------------------------
1301.03--Procedures information request      Drug Enforcement
 (controlled substances registration).        Administration, Attn:
1301.13(e)(2)--Request DEA Forms 224, 225,    Registration Section/ODR
 and 363..                                    P.O. Box 2639,
1301.14(a)--Controlled substances             Springfield, VA 22152-
 registration application submission..        2639.
1301.18(c)--Research project controlled
 substance increase request.
1301.51--Controlled substances registration
 modification request.
1301.52(b)--Controlled substances
 registration transfer request.
1309.03--List I chemicals registration
 procedures information request.
1309.32(c)--Request DEA Form 510.
1309.33(a)--List I chemicals registration
 application submission.
1309.61--List I chemicals registration
 modification request.
------------------------------------------------------------------------
                            DEA Hearing Clerk
------------------------------------------------------------------------
1316.45--Hearings documentation filing.....  Drug Enforcement
1316.46(a)--Inspection of record...........   Administration, Attn:
                                              Hearing Clerk/LJ, 8701
                                              Morrissette Drive,
                                              Springfield, VA 22152.
------------------------------------------------------------------------
                   DEA Federal Register Representative
------------------------------------------------------------------------
1316.47(a)--Request for hearing............  Drug Enforcement
                                              Administration, Attn:
                                              Federal Register
                                              Representative/ODL, 8701
                                              Morrissette Drive,
                                              Springfield, VA 22152.
------------------------------------------------------------------------

                       PARTS 1322	1399 [RESERVED]

[[Page 245]]



           CHAPTER III--OFFICE OF NATIONAL DRUG CONTROL POLICY




  --------------------------------------------------------------------
Part                                                                Page
1400

[Reserved]

1401            Public availability of information..........         247
1402            Mandatory declassification review...........         250
1403            Uniform administrative requirements for 
                    grants and cooperative agreements to 
                    State and local governments.............         251
1404            Governmentwide debarment and suspension 
                    (nonprocurement)........................         284
1405            Governmentwide requirements for drug-free 
                    workplace (financial assistance)........         307
1406-1499

 [Reserved]

[[Page 247]]

                          PART 1400 [RESERVED]



PART 1401_PUBLIC AVAILABILITY OF INFORMATION--Table of Contents



Sec.
1401.1 Purpose.
1401.2 The Office of National Drug Control Policy--organization and 
          functions.
1401.3 Definitions.
1401.4 Access to information.
1401.5 How to request records.
1401.6 Expedited process.
1401.7 Prompt response.
1401.8 Extension of time.
1401.9 Appeals.
1401.10 Fees to be charged--general.
1401.11 Fees to be charged--miscellaneous provisions.
1401.12 Fees to be charged--categories of requesters.
1401.13 Waiver or reduction of fees.

    Authority: 5 U.S.C. 552, as amended.

    Source: 64 FR 69901, Dec. 15, 1999, unless otherwise noted.



Sec. 1401.1  Purpose.

    The purpose of this part is to prescribe rules, guidelines and 
procedures to implement the Freedom of Information Act (FOIA), as 
amended, 5 U.S.C. 552.



Sec. 1401.2  The Office of National Drug Control Policy--organization
and functions.

    (a) The Office of National Drug Control Policy (ONDCP) was created 
by the Anti-Drug Abuse Act of 1988, 21 U.S.C. 1501 et seq., and 
reestablished under 21 U.S.C. 1701 et seq. The mission of ONDCP is to 
coordinate the anti-drug efforts of the various agencies and departments 
of the Federal government, to consult with States and localities and 
assist their anti-drug efforts, to conduct a national media campaign, 
and to annually promulgate the National Drug Control Strategy.
    (b) ONDCP is headed by the Director of National Drug Control Policy. 
The Director is assisted by a Deputy Director of National Drug Control 
Policy, a Deputy Director for Supply Reduction, a Deputy Director for 
Demand Reduction, and a Deputy Director for State and Local Affairs.
    (c) Offices within ONDCP include Chief of Staff, and the Offices of 
Legal Counsel, Strategic Planning, Legislative Affairs, Programs Budget 
and Evaluation, Supply Reduction, Demand Reduction, Public Affairs, 
State and Local Affairs, and the Financial Management Office.
    (d) The Office of Public Affairs is responsible for providing 
information to the press and to the general public. If members of the 
public have general questions about ONDCP that can be answered by 
telephone, they may call the Office of Public Affairs at (202) 395-6618. 
This number should not be used to make FOIA requests. All oral requests 
for information under FOIA will be rejected.



Sec. 1401.3  Definitions.

    For the purpose of this part:
    (a) All the terms defined in the Freedom of Information Act apply.
    (b) Commercial-use request means a request from or on behalf of one 
who seeks information for a cause or purpose that furthers the 
commercial, trade or profit interests of the requester or the person or 
institution on whose behalf the request is made. In determining whether 
a requester properly belongs in this category, ONDCP will consider the 
intended use of the information.
    (c) Direct costs means the expense actually expended to search, 
review, or duplicate in response to a FOIA request. For example, direct 
costs include 116% of the salary of the employee performing work and the 
actual costs incurred while operating equipment.
    (d) Duplicate means the process of making a copy of a document. Such 
copies may take the form of paper, microform, audio-visual materials, or 
machine-readable documentation. ONDCP will provide a copy of the 
material in a form that is usable by the requester.
    (e) Educational institution means preschool, a public or private 
elementary or secondary school, an institution of undergraduate higher 
education, an institution of graduate higher education, an institution 
of professional education, or an institution of vocational education 
that operates a program or programs of scholarly research.

[[Page 248]]

    (f) Noncommercial scientific institution means an institution that 
is not operated on a commercial basis as that term is defined in this 
section, and that is operated solely for the purpose of conducting 
scientific research not intended to promote any particular product or 
industry.
    (g) Records and any other terms used in this part in reference to 
information includes any information that would be an agency record 
subject to the requirements of this part when maintained in any format, 
including electronic format.
    (h) Representative of the news media means any person actively 
gathering news for an entity that is organized and operated to publish 
or broadcast news to the public. News is information about current 
events or information that would be of interest to the public. Examples 
of the news media include television or radio stations that broadcast to 
the public at large and publishers of news periodicals that make their 
products available to the general public for purchase or subscription. 
Freelance journalists may be regarded as working for the news media 
where they demonstrate a reasonable basis for expecting publication 
through that organization, even though not actually employed by it.
    (i) Request means a letter or other written communication seeking 
records or information under FOIA.
    (j) Review means the process of examining documents that are located 
during a search to determine if any portion should lawfully be withheld. 
It is the processing of determining disclosability.
    (k) Search means to review, manually or by automated means, agency 
records for the purpose of locating those records responsive to a 
request.



Sec. 1401.4  Access to information.

    The Office of National Drug Control Policy makes available 
information pertaining to matters issued, adopted, or promulgated by 
ONDCP, that are within the scope of 5 U.S.C. 552(a)(2). A public reading 
area and the ONDCP FOIA Handbook are located at http://
www.whitehousedrugpolicy.gov/about/about.html.



Sec. 1401.5  How to request records.

    (a) Each request must reasonably describe the record(s) sought 
including the type of document, specific event or action, originator of 
the record, date or time period, subject matter, location, and all other 
pertinent data.
    (b) Requests must be received by ONDCP through the mail or by 
electronic facsimile transmission. Mailed requests must be addressed to 
Executive Office of the President, Office of National Drug Control 
Policy, Office of Legal Counsel, Washington, DC 20503. The applicable 
fax number is (202) 395-5543.
    (c) The words ``FOIA REQUEST'' or ``REQUEST FOR RECORDS'' must be 
clearly marked on the cover-letter, letter and envelope. The time 
limitations imposed by Sec. 1401.7 will not begin until the Office of 
the General Counsel identifies a letter or fax as a FOIA request.



Sec. 1401.6  Expedited process.

    (a) Requests and appeals will be given expedited treatment whenever 
ONDCP determines either:
    (1) The lack of expedited treatment could reasonably be expected to 
pose an imminent threat to the life or physical safety of an individual; 
or
    (2) An urgency to inform the public about an actual or alleged 
federal government activity occurs and the request is made by a person 
primarily engaged in disseminating information.
    (b) A request for expedited processing may be made at the time of 
the initial request for records or at a later time.
    (c) A requester who seeks expedited processing must submit a 
statement, certified to be true and correct to the best of that person's 
knowledge and belief, explaining in detail the basis for requesting 
expedited processing. A requester within the category in paragraph 
(a)(2) of this section also must establish a particular urgency to 
inform the public about the government activity involved in the request, 
beyond the public's right to know about government activity generally. 
The formality of certification may be waived as a matter of 
administrative discretion.
    (d) Within ten days of receipt of a request for expedited 
processing, ONDCP will decide whether to grant it and will

[[Page 249]]

notify the requester of the decision. If a request for expedited 
treatment is granted, the request will be given priority and will be 
processed as soon as practicable. If a request for expedited processing 
is denied, any appeal of that decision will be acted on expeditiously.



Sec. 1401.7  Prompt response.

    The General Counsel, or designee, will determine within 20 days 
(excepting Saturdays, Sundays and legal public holidays) after the 
receipt of a FOIA request whether it is appropriate to grant the request 
and will provide written notification to the person making the request. 
If the request is denied, the written notification will include the 
names of the individuals who participated in the determination, the 
reasons for the denial, and that an appeal may be lodged within the 
Office of National Drug Control Policy.



Sec. 1401.8  Extension of time.

    (a) In unusual circumstances, the Office of General Counsel may 
extend the time limit prescribed in Sec. 1401.7 or Sec. 1401.9 by 
written notice to the FOIA requester. The notice will state the reasons 
for the extension and the date a determination is expected. The 
extension period may be divided among the initial request and an appeal 
but will not exceed a total of 10 working days (excepting Saturdays, 
Sundays, or legal public holidays).
    (b) The phrase ``unusual circumstances'' means:
    (1) The requested records are located in establishments that are 
separated from the office processing the request;
    (2) A voluminous amount of separate and distinct records are 
demanded in a single request; or
    (3) Another agency or two or more components in the same agency have 
substantial interest in the determination of the request.
    (c) Where unusual circumstance exist, ONDCP may provide an 
opportunity for amendment of the initial request so that the request may 
be timely processed. Refusal by the person to reasonably modify the 
request or arrange an alternative time frame shall be considered as a 
factor for purposes of 5 U.S.C. 552 (a)(6)(C).
    (d) ONDCP may aggregate requests by a requester or a group of 
requestors where multiple requests reasonably appear to be a single 
request.



Sec. 1401.9  Appeals.

    An appeal to the ONDCP must explain in writing the legal and factual 
basis for the appeal. It must be received by mail at the address 
specified in Sec. 1401.5 within 30 days of receipt of a denial. The 
Director or designee will decide the appeal within 20 days (excepting 
Saturdays, Sundays, and legal public holidays). If the Director or 
designee deny an appeal in whole or in part, the written determination 
will contain the reason for the denial, the names of the individuals who 
participated in the determination, and the provisions for judicial 
review.



Sec. 1401.10  Fees to be charged--general.

    ONDCP will recoup the full allowable costs it incurs in response to 
a FOIA request.
    (a) Manual search for records. ONDCP will charge 116% of the salary 
of the individual(s) making a search.
    (b) Computerized search for records. ONDCP will charge 116% of the 
salary of the programmer/operator and the apportionable time of the 
central processing unit directly attributed to the search.
    (c) Review of records. ONDCP will charge 116% of the salary of the 
individual(s) conducting a review. Records or portions of records 
withheld under an exemption subsequently determined not to apply may be 
reviewed to determine the applicability of exemptions not considered. 
The cost for a subsequent review is assessable.
    (d) Duplication of records. Request for copies prepared by computer 
will cost 116% of the apportionable operator time and the cost of the 
tape or disk. Other methods of duplication will cost 116% of the salary 
of the individual copying the data plus 15 cents per copy of 8\1/2\ x 11 
inch original.
    (e) Other charges. ONDCP will recover the costs of providing other 
services such as certifying records or sending records by special 
methods.

[[Page 250]]



Sec. 1401.11  Fees to be charged--miscellaneous provisions.

    (a) Remittance shall be mailed to the Office of Legal Counsel, 
ONDCP, Washington DC 20503, and made payable to the order of the 
Treasury of the United States on a postal money order or personal check 
or bank draft drawn on a bank in the United States.
    (b) ONDCP may require advance payment where the estimated fee 
exceeds $250, or a requester previously failed to pay within 30 days of 
the billing date.
    (c) ONDCP may assess interest charges beginning the 31st day of 
billing. Interest will be at the rate prescribed in section 3717 of 
title 31 of the United States Code and will accrue from the date of the 
billing.
    (d) ONDCP may assess search charges where records are not located or 
where records are exempt from disclosure.
    (e) ONDCP may aggregate individual requests and charge accordingly 
for requests seeking portions of a document or documents.



Sec. 1401.12  Fees to be charged--categories of requesters.

    (a) There are four categories of FOIA requesters: commercial use 
requesters; educational and non-commercial scientific institutions; 
representatives of the news media; and all other requesters.
    (b) The specific levels of fees for each of these categories are:
    (1) Commercial use requesters. ONDCP will recover the full direct 
cost of providing search, review and duplication services. Commercial 
use requesters will not receive free search-time or free reproduction of 
documents.
    (2) Educational and non-commercial scientific institution 
requesters. ONDCP will charge the cost of reproduction, excluding 
charges for the first 100 pages. Requesters must demonstrate the request 
is authorized by and under the auspices of a qualifying institution and 
that the records are sought for scholarly or scientific research not a 
commercial use.
    (3) Requesters who are representatives of the news media. ONDCP will 
charge the cost of reproduction, excluding charges for the first 100 
pages. Requesters must meet the criteria in Sec. 1401.3(h), and the 
request must not be made for a commercial use. A request that supports 
the news dissemination function of the requester shall not be considered 
a commercial use.
    (4) All other requesters. ONDCP will recover the full direct cost of 
the search and the reproduction of records, excluding the first 100 
pages of reproduction and the first two hours of search time. Requests 
for records concerning the requester will be treated under the fee 
provisions of the Privacy Act of 1974, 5 U.S.C. 552a, which permits fees 
only for reproduction.



Sec. 1401.13  Waiver or reduction of fees.

    Fees chargeable in connection with a request may be waived or 
reduced where ONDCP determines that disclosure is in the public interest 
because it is likely to contribute significantly to public understanding 
of the operations or activities of the Government and is not primarily 
in the commercial interest of the requester.



PART 1402_MANDATORY DECLASSIFICATION REVIEW--Table of Contents



Sec.
1402.1 Purpose.
1402.2 Responsibility.
1402.3 Information in the custody of ONDCP.
1402.4 Information classified by another agency.
1402.5 Appeal procedure.
1402.6 Fees.
1402.7 Suggestions and complaints.

    Authority: Section 3.4, E.O. 12356 (3 CFR, 1982 Comp., p. 166), and 
Information Security Oversight Office Directive No. 1 (32 CFR 2001.32).

    Source: 57 FR 55089, Nov. 24, 1992, unless otherwise noted.



Sec. 1402.1  Purpose.

    Other government agencies, U.S. citizens or permanent resident 
aliens may request that classified information in files of the Office of 
National Drug Control Policy (ONDCP) be reviewed for possible 
declassification and release. This part prescribes the procedures for 
such review and subsequent release or denial.

[[Page 251]]



Sec. 1402.2  Responsibility.

    All requests for the mandatory declassification review of classified 
information in ONDCP files should be addressed to the Security Officer, 
Office of National Drug Control Policy, Executive Office of the 
President, Washington, DC 20500, who will acknowledge receipt of the 
request. When a request does not reasonably describe the information 
sought, the requester shall be notified that unless additional 
information is provided, or the scope of the request is narrowed, no 
further action will be taken.



Sec. 1402.3  Information in the custody of ONDCP.

    Information contained in ONDCP files and under the exclusive 
declassification jurisdiction of ONDCP will be reviewed by the Director 
of the Office of Planning, Budget, and Administration of ONDCP and/or 
the office of primary interest to determine whether, under the 
declassification provisions of section 3.1 of Executive Order 12356 (3 
CFR, 1982 Comp., p. 166), the requested information may be declassified. 
If the information may not be released, in whole or in part, the 
requester shall be given a brief statement as to the reasons for denial, 
a notice of the right to appeal the determination to the Director of 
ONDCP, and a notice that such an appeal must be filed within 60 days in 
order to be considered.



Sec. 1402.4  Information classified by another agency.

    When a request is received for information that was classified by 
another agency, the Director of the Office of Planning, Budget, and 
Administration of ONDCP will forward the request and a copy of the 
document(s) along with any other related materials, to the appropriate 
agency for review and determination as to release. Recommendations as to 
release or denial may be made if appropriate. The requester will be 
notified of the referral, unless the receiving agency objects on the 
grounds that its association with the information requires protection.



Sec. 1402.5  Appeal procedure.

    Appeals reviewed as a result of a denial will be routed to the 
Director of ONDCP, who will take action as necessary to determine 
whether any part of the information may be declassified. If so, the 
Director shall notify the requester of this determination and shall make 
any information available that is declassified and is otherwise 
releasable. If continued classification is required, the requester shall 
be notified by the Director of ONDCP of the reasons therefore.



Sec. 1402.6  Fees.

    There will normally be no fees charged for the mandatory review of 
classified material for declassification under this part.



Sec. 1402.7  Suggestions and complaints.

    Suggestions and complaints regarding the information security 
program of ONDCP should be submitted, in writing, to the Security 
Officer, Office of National Drug Control Policy, Washington, DC 20500.



PART 1403_UNIFORM ADMINISTRATIVE REQUIREMENTS FOR GRANTS AND 
COOPERATIVE AGREEMENTS TO STATE AND LOCAL GOVERNMENTS--Table of 

Contents



                            Subpart A_General

Sec.
1403.1 Purpose and scope of this part.
1403.2 Scope of subpart.
1403.3 Definitions.
1403.4 Applicability.
1403.5 Effect on other issuances.
1403.6 Additions and exceptions.

                    Subpart B_Pre-Award Requirements

1403.10 Forms for applying for grants.
1403.11 State plans.
1403.12 Special grant or subgrant conditions for ``high-risk'' grantees.

                    Subpart C_Post-Award Requirements

                        Financial Administration

1403.20 Standards for financial management systems.
1403.21 Payment.
1403.22 Allowable costs.
1403.23 Period of availability of funds.
1403.24 Matching or cost sharing.
1403.25 Program income.
1403.26 Non-Federal audit.

[[Page 252]]

                    Changes, Property, and Subawards

1403.30 Changes.
1403.31 Real property.
1403.32 Equipment.
1403.33 Supplies.
1403.34 Copyrights.
1403.35 Subawards to debarred and suspended parties.
1403.36 Procurement.
1403.37 Subgrants.

              Reports, Records, Retention, and Enforcement

1403.40 Monitoring and reporting program performance.
1403.41 Financial reporting.
1403.42 Retention and access requirements for records.
1403.43 Enforcement.
1403.44 Termination for convenience.

                 Subpart D_After-The-Grant Requirements

1403.50 Closeout.
1403.51 Later disallowances and adjustments.
1403.52 Collection of amounts due.

Subpart E--Entitlement [Reserved]

Appendix A to Part 1403--OMB Circular A-128, ``Audits of State and Local 
          Governments''

    Authority: 5 U.S.C. 301.

    Source: 57 FR 55092, Nov. 24, 1992, unless otherwise noted.



                            Subpart A_General



Sec. 1403.1  Purpose and scope of this part.

    This part establishes uniform administrative rules for Federal 
grants and cooperative agreements and subawards to State, local and 
Indian tribal governments.



Sec. 1403.2  Scope of subpart.

    This subpart contains general rules pertaining to this part and 
procedures for control of exceptions from this part.



Sec. 1403.3  Definitions.

    As used in this part:
    Accrued expenditures mean the charges incurred by the grantee during 
a given period requiring the provision of funds for:
    (1) Goods and other tangible property received;
    (2) Services performed by employees, contractors, subgrantees, 
subcontractors, and other payees; and
    (3) Other amounts becoming owed under programs for which no current 
services or performance is required, such as annuities, insurance 
claims, and other benefit payments.
    Accrued income means the sum of:
    (1) Earnings during a given period from services performed by the 
grantee and goods and other tangible property delivered to purchasers, 
and
    (2) Amounts becoming owed to the grantee for which no current 
services or performance is required by the grantee.
    Acquisition cost of an item of purchased equipment means the net 
invoice unit price of the property including the cost of modifications, 
attachments, accessories, or auxiliary apparatus necessary to make the 
property usable for the purpose for which it was acquired. Other charges 
such as the cost of installation, transportation, taxes, duty or 
protective in-transit insurance, shall be included or excluded from the 
unit acquisition cost in accordance with the grantee's regular 
accounting practices.
    Administrative requirements mean those matters common to grants in 
general, such as financial management, kinds and frequency of reports, 
and retention of records. These are distinguished from ``programmatic'' 
requirements, which concern matters that can be treated only on a 
program-by-program or grant-by-grant basis, such as kinds of activities 
that can be supported by grants under a particular program.
    Awarding agency means:
    (1) With respect to a grant, the Federal agency, and
    (2) With respect to a subgrant, the party that awarded the subgrant.
    Cash contributions means the grantee's cash outlay, including the 
outlay of money contributed to the grantee or subgrantee by other public 
agencies and institutions, and private organizations and individuals. 
When authorized by Federal legislation, Federal funds received from 
other assistance agreements may be considered as grantee or subgrantee 
cash contributions.

[[Page 253]]

    Contract means (except as used in the definitions for ``grant'' and 
``subgrant'' in this section and except where qualified by ``Federal'') 
a procurement contract under a grant or subgrant, and means a 
procurement subcontract under a contract.
    Cost sharing or matching means the value of the third party in-kind 
contributions and the portion of the costs of a federally assisted 
project or program not borne by the Federal Government.
    Cost-type contract means a contract or subcontract under a grant in 
which the contractor or subcontractor is paid on the basis of the costs 
it incurs, with or without a fee.
    Equipment means tangible, nonexpendable, personal property having a 
useful life of more than one year and an acquisition cost of $5,000 or 
more per unit. A grantee may use its own definition of equipment 
provided that such definition would at least include all equipment 
defined above.
    Expenditure report means:
    (1) For nonconstruction grants, the SF-269 ``Financial Status 
Report'' (or other equivalent report);
    (2) For construction grants, the SF-271 ``Outlay Report and Request 
for Reimbursement'' (or other equivalent report).
    Federally recognized Indian tribal government means the governing 
body or a governmental agency of any Indian tribe, band, nation, or 
other organized group or community (including any Native village as 
defined in section 3 of the Alaska Native Claims Settlement Act, 85 
Stat. 688) certified by the Secretary of the Interior as eligible for 
the special programs and services provided by him through the Bureau of 
Indian Affairs.
    Government means a State or local government or a federally 
recognized Indian tribal government.
    Grant means an award of financial assistance, including cooperative 
agreements, in the form of money, or property in lieu of money, by the 
Federal Government to an eligible grantee. The term does not include 
technical assistance which provides services instead of money, or other 
assistance in the form of revenue sharing, loans, loan guarantees, 
interest subsidies, insurance, or direct appropriations. Also, the term 
does not include assistance, such as a fellowship or other lump sum 
award, which the grantee is not required to account for.
    Grantee means the government to which a grant is awarded and which 
is accountable for the use of the funds provided. The grantee is the 
entire legal entity even if only a particular component of the entity is 
designated in the grant award document.
    Local government means a county, municipality, city, town, township, 
local public authority (including any public and Indian housing agency 
under the United States Housing Act of 1937) school district, special 
district, intrastate district, council of governments (whether or not 
incorporated as a nonprofit corporation under state law), any other 
regional or interstate government entity, or any agency or 
instrumentality of a local government.
    Obligations means the amounts of orders placed, contracts and 
subgrants awarded, goods and services received, and similar transactions 
during a given period that will require payment by the grantee during 
the same or a future period.
    OMB means the United States Office of Management and Budget.
    Outlays (expenditures) means charges made to the project or program. 
They may be reported on a cash or accrual basis. For reports prepared on 
a cash basis, outlays are the sum of actual cash disbursement for direct 
charges for goods and service, the amount of indirect expense incurred, 
the value of in-kind contributions applied, and the amount of cash 
advances and payments made to contractors and subgrantees. For reports 
prepared on an accrued expenditure basis, outlays are the sum of actual 
cash disbursements, the amount of indirect expense incurred, the value 
of in-kind contributions applied, and the new increase (or decrease) in 
the amounts owed by the grantee for goods and other property received, 
for services performed by employees, contractors, subgrantees, 
subcontractors, and other payees, and other amounts becoming owed under 
programs for which no current services or performance are required, such 
as annuities, insurance claims, and other benefit payments.

[[Page 254]]

    Percentage of completion method refers to a system under which 
payments are made for construction work according to the percentage of 
completion of the work, rather than to the grantee's cost incurred.
    Prior approval means documentation evidencing consent prior to 
incurring specific cost.
    Real property means land, including land improvements, structures 
and appurtenances thereto, excluding movable machinery and equipment.
    Share, when referring to the awarding agency's portion of real 
property, equipment or supplies, means the same percentage as the 
awarding agency's portion of the acquiring party's total costs under the 
grant to which the acquisition costs under the grant to which the 
acquisition cost of the property was charged. Only costs are to be 
counted--not the value of third-party in-kind contributions.
    State means any of the several States of the United States, the 
District of Columbia, the Commonwealth of Puerto Rico, any territory or 
possession of the United States, or any agency or instrumentality of a 
State exclusive of local governments. The term does not include any 
public and Indian housing agency under United States Housing Act of 
1937.
    Subgrant means an award of financial assistance in the form of 
money, or property in lieu of money, made under a grant by a grantee to 
an eligible subgrantee. The term includes financial assistance when 
provided by contractual legal agreement, but does not include 
procurement purchases, nor does it include any form of assistance which 
is excluded from the definition of ``grant'' in this part.
    Subgrantee means the government or other legal entity to which a 
subgrant is awarded and which is accountable to the grantee for the use 
of the funds provided.
    Supplies means all tangible personal property other than 
``equipment'' as defined in this part.
    Suspension means depending on the context, either
    (1) Temporary withdrawal of the authority to obligate grant funds 
pending corrective action by the grantee or subgrantee or a decision to 
terminate the grant, or
    (2) In action taken by a suspending official in accordance with 
agency regulations implementing E.O. 12549 to immediately exclude a 
person from participating in grant transactions for a period, pending 
completion of an investigation and such legal or debarment proceedings 
as may ensue.
    Termination means permanent withdrawal of the authority to obligate 
previously-awarded grant funds before that authority would otherwise 
expire. It also means the voluntary relinquishment of that authority by 
the grantee or subgrantee. ``Termination'' does not include:
    (1) Withdrawal of funds awarded on the basis of the grantee's 
underestimate of the unobligated balance in a prior period;
    (2) Withdrawal of the unobligated balance as of the expiration of a 
grant;
    (3) Refusal to extend a grant or award additional funds, to make a 
competing or noncompeting continuation, renewal, extension, or 
supplemental award; or
    (4) Voiding of a grant upon determination that the award was 
obtained fraudulently, or was otherwise illegal or invalid from 
inception.
    Terms of a grant or subgrant mean all requirements of the grant or 
subgrant, whether in statute, regulations, or the award document.
    Third party in-kind contributions mean property or services which 
benefit a federally assisted project or program and which are 
contributed by non-Federal third parties without charge to the grantee, 
or a cost-type contractor under the grant agreement.
    Unliquidated obligations for reports prepared on a cash basis mean 
the amount of obligations incurred by the grantee that has not been 
paid. For reports prepared on an accrued expenditure basis, they 
represent the amount of obligations incurred by the grantee for which an 
outlay has not been recorded.
    Unobligated balance means the portion of the funds authorized by the 
Federal agency that has not been obligated by the grantee and is 
determined

[[Page 255]]

by deducting the cumulative obligations from the cumulative funds 
authorized.



Sec. 1403.4  Applicability.

    (a) General. Subparts A-D of this part apply to all grants and 
subgrants to governments, except where inconsistent with Federal 
statutes or with regulations authorized in accordance with the exception 
provision of Sec. 1403.6, or:
    (1) Grants and subgrants to State and local institutions of higher 
education or State and local hospitals;
    (2) The block grants authorized by the Omnibus Budget Reconciliation 
Act of 1981 (Community Services; Preventive Health and Health Services; 
Alcohol, Drug Abuse, and Mental Health Services; Maternal and Child 
Health Services; Social Services; Low-Income Home Energy Assistance; 
States' Program of Community Development Block Grants for Small Cities; 
and Elementary and Secondary Education other than programs administered 
by the Secretary of Education under title V, subtitle D, chapter 2, 
section 583--the Secretary's discretionary grant program) and titles I-
III of the Job Training Partnership Act of 1982 and under the Public 
Health Services Act (Section 1921), Alcohol and Drug Abuse Treatment and 
Rehabilitation Block Grant and part C of title V, Mental Health Service 
for the Homeless Block Grant);
    (3) Entitlement grants to carry out the following programs of the 
Social Security Act:
    (i) Aid to Needy Families with Dependent Children (title IV-A of the 
Act, not including the Work Incentive Program (WIN) authorized by 
section 402(a)19(G); HHS grants for WIN are subject to this part);
    (ii) Child Support Enforcement and Establishment of Paternity (title 
IV-D of the Act);
    (iii) Foster Care and Adoption Assistance (title IV-E of the Act);
    (iv) Aid to the Aged, Blind, and Disabled (titles I, X, XIV, and 
XVI-AABD of the Act); and
    (v) Medical Assistance (Medicaid) (title XIX of the Act) not 
including the State Medicaid Fraud Control program authorized by section 
1903(a)(6)(B);
    (4) Entitlement grants under the following programs of The National 
School Lunch Act:
    (i) School Lunch (section 4 of the Act),
    (ii) Commodity Assistance (section 6 of the Act),
    (iii) Special Meal Assistance (section 11 of the Act),
    (iv) Summer Food Service for Children (section 13 of the Act), and
    (v) Child Care Food Program (section 17 of the Act);
    (5) Entitlement grants under the following programs of The Child 
Nutrition Act of 1966:
    (i) Special Milk (section 3 of the Act), and
    (ii) School Breakfast (section 4 of the Act);
    (6) Entitlement grants for State Administrative expenses under The 
Food Stamp Act of 1977 (section 16 of the Act);
    (7) A grant for an experimental, pilot, or demonstration project 
that is also supported by a grant listed in paragraph (a)(3) of this 
section;
    (8) Grant funds awarded under subsection 412(e) of the Immigration 
and Nationality Act (8 U.S.C. 1522(e)) and subsection 501(a) of the 
Refugee Education Assistance Act of 1980 (Pub. L. 96-422, 94 Stat. 
1809), for cash assistance, medical assistance, and supplemental 
security income benefits to refugees and entrants and the administrative 
costs of providing the assistance and benefits;
    (9) Grants to local education agencies under 20 U.S.C. 236 through 
241-1(a), and 242 through 244 (portions of the Impact Aid program), 
except for 20 U.S.C. 238(d)(2)(c) and 240(f) (Entitlement Increase for 
Handicapped Children); and
    (10) Payments under the Veterans Administration's State Home Per 
Diem Program (38 U.S.C. 641(a)).
    (b) Entitlement programs. Entitlement programs enumerated above in 
Sec. 1403.4(a) (3) through (8) are subject to subpart E.



Sec. 1403.5  Effect on other issuances.

    All other grants administration provisions of codified program 
regulations, program manuals, handbooks and other nonregulatory 
materials which are inconsistent with this part

[[Page 256]]

are superseded, except to the extent they are required by statute, or 
authorized in accordance with the exception provision in Sec. 1403.6.



Sec. 1403.6  Additions and exceptions.

    (a) For classes of grants and grantees subject to this part, Federal 
agencies may not impose additional administrative requirements except in 
codified regulations published in the Federal Register.
    (b) Exceptions for classes of grants or grantees may be authorized 
only by OMB.
    (c) Exceptions on a case-by-case basis and for subgrantees may be 
authorized by the affected Federal agencies.



                    Subpart B_Pre-Award Requirements



Sec. 1403.10  Forms for applying for grants.

    (a) Scope. (1) This section prescribes forms and instructions to be 
used by governmental organizations (except hospitals and institutions of 
higher education operated by a government) in applying for grants. This 
section is not applicable, however, to formula grant programs which do 
not require applicants to apply for funds on a project basis.
    (2) This section applies only to applications to Federal agencies 
for grants, and is not required to be applied by grantees in dealing 
with applicants for subgrants. However, grantees are encouraged to avoid 
more detailed or burdensome application requirements for subgrants.
    (b) Authorized forms and instructions for governmental 
organizations. (1) In applying for grants, applicants shall only use 
standard application forms or those prescribed by the granting agency 
with the approval of OMB under the Paperwork Reduction Act of 1980.
    (2) Applicants are not required to submit more than the original and 
two copies of preapplications or applications.
    (3) Applicants must follow all applicable instructions that bear OMB 
clearance numbers. Federal agencies may specify and describe the 
programs, functions, or activities that will be used to plan, budget, 
and evaluate the work under a grant. Other supplementary instructions 
may be issued only with the approval of OMB to the extent required under 
the Paperwork Reduction Act of 1980. For any standard form, except the 
SF-424 facesheet, Federal agencies may shade out or instruct the 
applicant to disregard any line item that is not needed.
    (4) When a grantee applies for additional funding (such as a 
continuation or supplemental award) or amends a previously submitted 
application, only the affected pages need be submitted. Previously 
submitted pages with information that is still current need not be 
resubmitted.



Sec. 1403.11  State plans.

    (a) Scope. The statutes for some programs require States to submit 
plans before receiving grants. Under regulations implementing Executive 
Order 12372, ``Intergovernmental Review of Federal Programs,'' States 
are allowed to simplify, consolidate and substitute plans. This section 
contains additional provisions for plans that are subject to regulations 
implementing the Executive Order.
    (b) Requirements. A State need meet only Federal administrative or 
programmatic requirements for a plan that are in statutes or codified 
regulations.
    (c) Assurances. In each plan the States will include an assurance 
that the State shall comply with all applicable Federal statutes and 
regulations in effect with respect to the periods for which it receives 
grant funding. For this assurance and other assurances required in the 
plan, the State may:
    (1) Cite by number the statutory or regulatory provisions requiring 
the assurances and affirm that it gives the assurances required by those 
provisions,
    (2) Repeat the assurance language in the statutes or regulations, or
    (3) Develop its own language to the extent permitted by law.
    (d) Amendments. A State will amend a plan whenever necessary to 
reflect: (1) New or revised Federal statutes or regulations or (2) a 
material change in any State law, organization, policy, or State agency 
operation. The State will obtain approval for the amendment and

[[Page 257]]

its effective date but need submit for approval only the amended 
portions of the plan.



Sec. 1403.12  Special grant or subgrant conditions for ``high-risk''
grantees.

    (a) A grantee or subgrantee may be considered ``high risk'' if an 
awarding agency determines that a grantee or subgrantee:
    (1) Has a history of unsatisfactory performance, or
    (2) Is not financially stable, or
    (3) Has a management system which does not meet the management 
standards set forth in this part, or
    (4) Has not conformed to terms and conditions of previous awards, or
    (5) Is otherwise not responsible; and if the awarding agency 
determines that an award will be made, special conditions and/or 
restrictions shall correspond to the high risk condition and shall be 
included in the award.
    (b) Special conditions or restrictions may include:
    (1) Payment on a reimbursement basis;
    (2) Withholding authority to proceed to the next phase until receipt 
of evidence of acceptable performance within a given funding period;
    (3) Requiring additional, more detailed financial reports;
    (4) Additional project monitoring;
    (5) Requiring the grantee or subgrantee to obtain technical or 
management assistance; or
    (6) Establishing additional prior approvals;
    (c) If an awarding agency decides to impose such conditions, the 
awarding official will notify the grantee or subgrantee as early as 
possible, in writing, of:
    (1) The nature of the special conditions/restrictions;
    (2) The reason(s) for imposing them;
    (3) The corrective actions which must be taken before they will be 
removed and the time allowed for completing the corrective actions; and
    (4) The method of requesting reconsideration of the conditions/
restrictions imposed.



                    Subpart C_Post-Award Requirements

                        Financial Administration



Sec. 1403.20  Standards for financial management systems.

    (a) A State must expend and account for grant funds in accordance 
with State laws and procedures for expending and accounting for its own 
funds. Fiscal control and accounting procedures of the State, as well as 
its subgrantees and cost-type contractors, must be sufficient to--
    (1) Permit preparation of reports required by this part and the 
statutes authorizing the grant, and
    (2) Permit the tracing of funds to a level of expenditures adequate 
to establish that such funds have not been used in violation of the 
restrictions and prohibitions of applicable statutes.
    (b) The financial management systems of other grantees and 
subgrantees must meet the following standards:
    (1) Financial reporting. Accurate, current, and complete disclosure 
of the financial results of financially assisted activities must be made 
in accordance with the financial reporting requirements of the grant or 
subgrant.
    (2) Accounting records. Grantees and subgrantees must maintain 
records which adequately identify the source and application of funds 
provided for financially-assisted activities. These records must contain 
information pertaining to grant or subgrant awards and authorizations, 
obligations, unobligated balances, assets, liabilities, outlays or 
expenditures, and income.
    (3) Internal control. Effective control and accountability must be 
maintained for all grant and subgrant cash, real and personal property, 
and other assets. Grantees and subgrantees must adequately safeguard all 
such property and must assure that it is used solely for authorized 
purposes.
    (4) Budget control. Actual expenditures or outlays must be compared 
with budgeted amounts for each grant or subgrant. Financial information

[[Page 258]]

must be related to performance or productivity data, including the 
development of unit cost information whenever appropriate or 
specifically required in the grant or subgrant agreement. If unit cost 
data are required, estimates based on available documentation will be 
accepted whenever possible.
    (5) Allowable cost. Applicable OMB cost principles, agency program 
regulations, and the terms of grant and subgrant agreements will be 
followed in determining the reasonableness, allowability, and 
allocability of costs.
    (6) Source documentation. Accounting records must be supported by 
such source documentation as canceled checks, paid bills, payrolls, time 
and attendance records, contract and subgrant award documents, etc.
    (7) Cash management. Procedures for minimizing the time elapsing 
between the transfer of funds from the U.S. Treasury and disbursement by 
grantees and subgrantees must be followed whenever advance payment 
procedures are used. Grantees must establish reasonable procedures to 
ensure the receipt of reports on subgrantees' cash balances and cash 
disbursements in sufficient time to enable them to prepare complete and 
accurate cash transactions reports to the awarding agency. When advances 
are made by letter-of-credit or electronic transfer of funds methods, 
the grantee must make drawdowns as close as possible to the time of 
making disbursements. Grantees must monitor cash drawdowns by their 
subgrantees to assure that they conform substantially to the same 
standards of timing and amount as apply to advances to the grantees.
    (c) An awarding agency may review the adequacy of the financial 
management system of any applicant for financial assistance as part of a 
preaward review or at any time subsequent to award.



Sec. 1403.21  Payment.

    (a) Scope. This section prescribes the basic standard and the 
methods under which a Federal agency will make payments to grantees, and 
grantees will make payments to subgrantees and contractors.
    (b) Basic standard. Methods and procedures for payment shall 
minimize the time elapsing between the transfer of funds and 
disbursement by the grantee or subgrantee, in accordance with Treasury 
regulations at 31 CFR part 205.
    (c) Advances. Grantees and subgrantees shall be paid in advance, 
provided they maintain or demonstrate the willingness and ability to 
maintain procedures to minimize the time elapsing between the transfer 
of the funds and their disbursement by the grantee or subgrantee.
    (d) Reimbursement. Reimbursement shall be the preferred method when 
the requirements in paragraph (c) of this section are not met. Grantees 
and subgrantees may also be paid by reimbursement for any construction 
grant. Except as otherwise specified in regulation, Federal agencies 
shall not use the percentage of completion method to pay construction 
grants. The grantee or subgrantee may use that method to pay its 
construction contractor, and if it does, the awarding agency's payments 
to the grantee or subgrantee will be based on the grantee's or 
subgrantee's actual rate of disbursement.
    (e) Working capital advances. If a grantee cannot meet the criteria 
for advance payments described in paragraph (c) of this section, and the 
Federal agency has determined that reimbursement is not feasible the 
grantee lacks sufficient working capital, the awarding agency may 
provide cash or a working capital advance basis. Under this procedure 
the awarding agency shall advance cash to the grantee to cover its 
estimated disbursement needs for an initial period generally geared to 
the grantee's disbursing cycle. Thereafter, the awarding agency shall 
reimburse the grantee for its actual cash disbursements. The working 
capital advance method of payment shall not be used by grantees or 
subgrantees if the reason for using such method is the unwillingness or 
inability of the grantee to provide timely advances to the subgrantee to 
meet the subgrantee's actual cash disbursements.
    (f) Effect of program income, refunds, and audit recoveries on 
payment. (1) Grantees and subgrantees shall disburse repayments to and 
interest

[[Page 259]]

earned on a revolving fund before requesting additional cash payments 
for the same activity.
    (2) Except as provided in paragraph (f)(1) of this section, grantees 
and subgrantees shall disburse program income, rebates, refunds, 
contract settlements, audit recoveries and interest earned on such funds 
before requesting additional cash payments.
    (g) Withholding payments. (1) Unless otherwise required by Federal 
statute, awarding agencies shall not withhold payments for proper 
charges incurred by grantees or subgrantees unless--
    (i) The grantee or subgrantee has failed to comply with grant award 
conditions or
    (ii) The grantee or subgrantee is indebted to the United States.
    (2) Cash withheld for failure to comply with grant award condition, 
but without suspension of the grant, shall be released to the grantee 
upon subsequent compliance. When a grant is suspended, payment 
adjustments will be made in accordance with Sec. 1403.43(c).
    (3) A Federal agency shall not make payment to grantees for amounts 
that are withheld by grantees or subgrantees from payment to contractors 
to assure satisfactory completion of work. Payments shall be made by the 
Federal agency when the grantees or subgrantees actually disburse the 
withheld funds to the contractors or to escrow accounts established to 
assure satisfactory completion of work.
    (h) Cash depositories. (1) Consistent with the national goal of 
expanding the opportunities for minority business enterprises, grantees 
and subgrantees are encouraged to use minority banks (a bank which is 
owned at least 50 percent by minority group members). A list of minority 
owned banks can be obtained from the Minority Business Development 
Agency, Department of Commerce, Washington, DC 20230.
    (2) A grantee or subgrantee shall maintain a separate bank account 
only when required by Federal-State agreement.
    (i) Interest earned on advances. Except for interest earned on 
advances of funds exempt under the Intergovernmental Cooperation Act (31 
U.S.C. 6501 et seq.) and the Indian Self-Determination Act (23 U.S.C. 
450), grantees and subgrantees shall promptly, but at least quarterly, 
remit interest earned on advances to the Federal agency. The grantee or 
subgrantee may keep interest amounts up to $100 per year for 
administrative expenses.



Sec. 1403.22  Allowable costs.

    (a) Limitation on use of funds. Grant funds may be used only for:
    (1) The allowable costs of the grantees, subgrantees and cost-type 
contractors, including allowable costs in the form of payments to fixed-
price contractors; and
    (2) Reasonable fees or profit to cost-type contractors but not any 
fee or profit (or other increment above allowable costs) to the grantee 
or subgrantee.
    (b) Applicable cost principles. For each kind of organization, there 
is a set of Federal principles for determining allowable costs. 
Allowable costs will be determined in accordance with the cost 
principles applicable to the organization incurring the costs. The 
following chart lists the kinds of organizations and the applicable cost 
principles.

------------------------------------------------------------------------
           For the costs of a--                Use the principles in--
------------------------------------------------------------------------
State, local or Indian tribal government..  OMB Circular A-87.
Private nonprofit organization other than   OMB Circular A-122.
 (1) institution of higher education, (2)
 hospital, or (3) organization named in
 OMB Circular A-122 as not subject to that
 circular.
Educational institutions..................  OMB Circular A-21.
For-profit organizations other than a       48 CFR part 31. Contract
 hospital and an organization named in OMB   Cost Principles and
 Circular A-122 as not subject to that       Procedures, or uniform cost
 circular.                                   accounting standards that
                                             comply with cost principles
                                             acceptable to the Federal
                                             agency.
------------------------------------------------------------------------



Sec. 1403.23  Period of availability of funds.

    (a) General. Where a funding period is specified, a grantee may 
charge to the award only costs resulting from obligations of the funding 
period unless carryover of unobligated balances is permitted, in which 
case the carryover balances may be charged for costs resulting from 
obligations of the subsequent funding period.

[[Page 260]]

    (b) Liquidation of obligations. A grantee must liquidate all 
obligations incurred under the award not later than 90 days after the 
end of the funding period (or as specified in a program regulation) to 
coincide with the submission of the annual Financial Status Report (SF-
269). The Federal agency may extend this deadline at the request of the 
grantee.



Sec. 1403.24  Matching or cost sharing.

    (a) Basic rule: Costs and contributions acceptable. With the 
qualifications and exceptions listed in paragraph (b) of this section, a 
matching or cost sharing requirement may be satisfied by either or both 
of the following:
    (1) Allowable costs incurred by the grantee, subgrantee or a cost-
type contractor under the assistance agreement. This includes allowable 
costs borne by non-Federal grants or by others cash donations from non-
Federal third parties.
    (2) The value of third party in-kind contributions applicable to the 
period to which the cost sharing or matching requirements applies.
    (b) Qualifications and exceptions(1) Costs borne by other Federal 
grant agreements. Except as provided by Federal statute, a cost sharing 
or matching requirement may not be met by costs borne by another Federal 
grant. This prohibition does not apply to income earned by a grantee or 
subgrantee from a contract awarded under another Federal grant.
    (2) General revenue sharing. For the purpose of this section, 
general revenue sharing funds distributed under 31 U.S.C. 6702 are not 
considered Federal grant funds.
    (3) Cost or contributions counted towards other Federal cost-sharing 
requirements. Neither costs nor the values of third party in-kind 
contributions may count towards satisfying a cost sharing or matching 
requirement of a grant agreement if they have been or will be counted 
towards satisfying a cost sharing or matching requirement of another 
Federal grant agreement, a Federal procurement contract, or any other 
award of Federal funds.
    (4) Costs financed by program income. Costs financed by program 
income, as defined in Sec. 1403.25, shall not count towards satisfying 
a cost sharing or matching requirement unless they are expressly 
permitted in the terms of the assistant agreement. (This use of general 
program income is described in Sec. 1403.25(g).)
    (5) Services or property financed by income earned by contractors. 
Contractors under a grant may earn income from the activities carried 
out under the contract in addition to the amounts earned from the party 
awarding the contract. No costs of services or property supported by 
this income may count toward satisfying cost sharing or matching 
requirement unless other provisions of the grant agreement expressly 
permit this kind of income to be used to meet the requirement.
    (6) Records. Costs and third party in-kind contributions counting 
towards satisfying a cost sharing or matching requirement must be 
verifiable from the records of grantees and subgrantee or cost-type 
contractors. These records must show how the value placed on third party 
in-kind contributions was derived. To the extent feasible, volunteer 
services will be supported by the same methods that the organization 
uses to support the allocability of regular personnel costs.
    (7) Special standards for third party in-kind contributions. (i) 
Third party in-kind contributions count towards satisfying a cost 
sharing or matching requirement only where, if the party receiving the 
contributions were to pay for them, the payments would be allowable 
costs.
    (ii) Some third party in-kind contributions are goods and services 
that, if the grantee, subgrantee, or contractor receiving the 
contribution had to pay for them, the payments would have been an 
indirect costs. Costs sharing or matching credit for such contributions 
shall be given only if the grantee, subgrantee, or contractor has 
established, along with its regular indirect cost rate, a special rate 
for allocating to individual projects or programs the value of the 
contributions.
    (iii) A third party in-kind contribution to a fixed-price contract 
may count towards satisfying a cost sharing or matching requirement only 
if it results in:

[[Page 261]]

    (A) An increase in the services or property provided under the 
contract (without additional cost to the grantee or subgrantee) or
    (B) A cost savings to the grantee or subgrantee.
    (iv) The values placed on third party in-kind contributions for cost 
sharing or matching purposes will conform to the rules in the succeeding 
sections of this part. If a third party in-kind contribution is a type 
not treated in those sections, the value placed upon it shall be fair 
and reasonable.
    (c) Valuation of donated services(1) Volunteer services. Unpaid 
services provided to a grantee or subgrantee by individuals will be 
valued at rates consistent with those ordinarily paid for similar work 
in the grantee's or subgrantee's organization. If the grantee or 
subgrantee does not have employees performing similar work, the rates 
will be consistent with those ordinarily paid by other employers for 
similar work in the same labor market. In either case, a reasonable 
amount for fringe benefits may be included in the valuation.
    (2) Employees of other organizations. When an employer other than a 
grantee, subgrantee, or cost-type contractor furnishes free of charge 
the services of an employee in the employee's normal line of work, the 
services will be valued at the employee's regular rate of pay exclusive 
of the employee's fringe benefits and overhead costs. If the services 
are in a different line of work, paragraph (c)(1) of this section 
applies.
    (d) Valuation of third party donated supplies and loaned equipment 
or space. (1) If a third party donates supplies, the contribution will 
be valued at the market value of the supplies at the time of donation.
    (2) If a third party donates the use of equipment or space in a 
building but retains title, the contribution will be valued at the fair 
rental rate of the equipment or space.
    (e) Valuation of third party donated equipment, buildings, and land. 
If a third party donates equipment, buildings, or land, and title passes 
to a grantee or subgrantee, the treatment of the donated property will 
depend upon the purpose of the grant or subgrant, as follows:
    (1) Awards for capital expenditures. If the purpose of the grant or 
subgrant is to assist the grantee or subgrantee in the acquisition of 
property, the market value of that property at the time of donation may 
be counted as cost sharing or matching.
    (2) Other awards. If assisting in the acquisition of property is not 
the purpose of the grant or subgrant, paragraphs (e)(2) (i) and (ii) of 
this section apply:
    (i) If approval is obtained from the awarding agency, the market 
value at the time of donation of the donated equipment or buildings and 
the fair rental rate of the donated land may be counted as cost sharing 
or matching. In the case of a subgrant, the terms of the grant agreement 
may require that the approval be obtained from the Federal agency as 
well as the grantee. In all cases, the approval may be given only if a 
purchase of the equipment or rental of the land would be approved as an 
allowable direct cost. If any part of the donated property was acquired 
with Federal funds, only the non-federal share of the property may be 
counted as cost-sharing or matching.
    (ii) If approval is not obtained under paragraph (e)(2)(i) of this 
section, no amount may be counted for donated land, and only 
depreciation or use allowances may be counted for donated equipment and 
buildings. The depreciation or use allowances for this property are not 
treated as third party in-kind contributions. Instead, they are treated 
as costs incurred by the grantee or subgrantee. They are computed and 
allocated (usually as indirect costs) in accordance with the cost 
principles specified in Sec. 1403.22, in the same way as depreciation 
or use allowances for purchased equipment and buildings. The amount of 
depreciation or use allowances for donated equipment and buildings is 
based on the property's market value at the time it was donated.
    (f) Valuation of grantee or subgrantee donates real property for 
construction/acquisition. If a grantee or subgrantee donates real 
property for a construction or facilities acquisition project, the 
current market value of that property may be counted as cost sharing or 
matching. If any part of the donated property was acquired with Federal

[[Page 262]]

funds, only the non-federal share of the property may be counted as cost 
sharing or matching.
    (g) Appraisal of real property. In some cases under paragraphs (d), 
(e) and (f) of this section, it will be necessary to establish the 
market value of land or a building or the fair rental rate of land or of 
space in a building. In these cases, the Federal agency may require the 
market value or fair rental value be set by an independent appraiser, 
and that the value or rate be certified by the grantee. This requirement 
will also be imposed by the grantee on subgrantees.



Sec. 1403.25  Program income.

    (a) General. Grantees are encouraged to earn income to defray 
program costs. Program income includes income from fees for services 
performed, from the use of rental of real or personal property acquired 
with grant funds, from the sale of commodities or items fabricated under 
a grant agreement, and from payments of principal and interest on loans 
made with grant funds. Except as otherwise provided in regulations of 
the Federal agency, program income does not include interest on grant 
funds, rebates, credits, discounts, refunds, etc., and interest earned 
on any of them.
    (b) Definition of program income. Program income means gross income 
received by the grantee or subgrantee directly generated by a grant 
supported activity, or earned only as a result of the grant agreement 
during the grant period. ``During the grant period'' is the time between 
the effective date of the award and the ending date of the award 
reflected in the final financial report.
    (c) Cost of generating program income. If authorized by Federal 
regulations or the grant agreement, costs incident to the generation of 
program income may be deducted from gross income to determine program 
income.
    (d) Governmental revenues. Taxes, special assessments levies, fines, 
and other such revenues raised by a grantee or subgrantee are not 
program income unless the revenues are specifically identified in the 
grant agreement or Federal agency regulations as program income.
    (e) Royalties. Income from royalties and license fees for 
copyrighted material, patents, and inventions developed by a grantee or 
subgrantee is program income only if the revenues are specifically 
identified in the grant agreement or Federal agency regulations as 
program income. (See Sec. 1403.34.)
    (f) Property. Proceeds from the sale of real property or equipment 
will be handled in accordance with the requirements of Sec. 1403.31 and 
Sec. 1403.32.
    (g) Use of program income. Program income shall be deducted from 
outlays which may be both Federal and non-Federal as described below, 
unless the Federal agency regulations or the grant agreement specify 
another alternative (or a combination of the alternatives). In 
specifying alternatives, the Federal agency may distinguish between 
income earned by the grantee and income earned by subgrantees and 
between the sources, kinds, or amounts of income. When Federal agencies 
authorize the alternatives in paragraphs (g) (2) and (3) of this 
section, program income in excess of any limits stipulated shall also be 
deducted from outlays.
    (1) Deduction. Ordinarily program income shall be deducted from 
total allowable costs to determine the net allowable costs. Program 
income shall be used for current costs unless the Federal agency 
authorizes otherwise. Program income which the grantee did not 
anticipate at the time of the award shall be used to reduce the Federal 
agency and grantee contributions rather than to increase the funds 
committed to the project.
    (2) Addition. When authorized, program income may be added to the 
funds committed to the grant agreement by the Federal agency and the 
grantee. The program income shall be used for the purposes and under the 
conditions of the grant agreement.
    (3) Cost sharing or matching. When authorized, program income may be 
used to meet the cost sharing or matching requirement of the grant 
agreement. The amount of the Federal grant award remains the same.
    (h) Income after the award period. There are no Federal requirements 
governing the disposition of program income earned after the end of the 
award

[[Page 263]]

period (i.e., until the ending date of the final financial report, see 
paragraph (a) of this section), unless the terms of the agreement or the 
Federal agency regulations provide otherwise.



Sec. 1403.26  Non-Federal audit.

    (a) Basic rule. Grantees and subgrantees are responsible for 
obtaining audits in accordance with the Single Audit Act Amendments of 
1996 (31 U.S.C. 7501-7507) and revised OMB Circular A-133, ``Audits of 
States, Local Governments, and Non-Profit Organizations.'' The audits 
shall be made by an independent auditor in accordance with generally 
accepted government auditing standards covering financial audits.
    (b) Subgrantees. State or local governments, as those terms are 
defined for purposes of the Single Audit Act Amendments of 1996, that 
provide Federal awards to a subgrantee, which expends $300,000 or more 
(or other amount as specified by OMB) in Federal awards in a fiscal 
year, shall:
    (1) Determine whether State or local subgrantees have met the audit 
requirements of the Act and whether subgrantees covered by OMB Circular 
A-110, ``Uniform Administrative Requirements for Grants and Agreements 
with Institutions of Higher Education, Hospitals, and Other Non-Profit 
Organizations,'' have met the audit requirements of the Act. Commercial 
contractors (private for-profit and private and governmental 
organizations) providing goods and services to State and local 
governments are not required to have a single audit performed. State and 
local governments should use their own procedures to ensure that the 
contractor has complied with laws and regulations affecting the 
expenditure of Federal funds;
    (2) Determine whether the subgrantee spent Federal assistance funds 
provided in accordance with applicable laws and regulations. This may be 
accomplished by reviewing an audit of the subgrantee made in accordance 
with the Act, Circular A-110, or through other means (e.g., program 
reviews) if the subgrantee has not had such an audit;
    (3) Ensure that appropriate corrective action is taken within six 
months after receipt of the audit report in instance of noncompliance 
with Federal laws and regulations;
    (4) Consider whether subgrantee audits necessitate adjustment of the 
grantee's own records; and
    (5) Require each subgrantee to permit independent auditors to have 
access to the records and financial statements.
    (c) Auditor selection. In arranging for audit services, Sec. 
1403.36 shall be followed.

[57 FR 55092, Nov. 24, 1992, as amended at 62 FR 45939, 45941, Aug. 29, 
1997]

                    Changes, Property, and Subawards



Sec. 1403.30  Changes.

    (a) General. Grantees and subgrantees are permitted to rebudget 
within the approved direct cost budget to meet unanticipated 
requirements and may make limited program changes to the approved 
project. However, unless waived by the awarding agency, certain types of 
post-award changes in budgets and projects shall require the prior 
written approval of the awarding agency.
    (b) Relation to cost principles. The applicable cost principles (see 
Sec. 1403.22) contain requirements for prior approval of certain types 
of costs. Except where waived, those requirements apply to all grants 
and subgrants even if paragraphs (c) through (f) of this section do not.
    (c) Budget changes(1) Nonconstruction projects. Except as stated in 
other regulations or an award document, grantees or subgrantees shall 
obtain the prior approval of the awarding agency whenever any of the 
following changes is anticipated under a nonconstruction award:
    (i) Any revision which would result in the need for additional 
funding.
    (ii) Unless waived by the awarding agency, cumulative transfers 
among direct cost categories, or, if applicable, among separately 
budgeted programs, projects, functions, or activities which exceed or 
are expected to exceed ten percent of the current total approved budget, 
whenever the awarding agency's share exceeds $100,000.
    (iii) Transfer of funds allotted for training allowances (i.e., from 
direct

[[Page 264]]

payments to trainees to other expense categories).
    (2) Construction projects. Grantees and subgrantees shall obtain 
prior written approval for any budget revision which would result in the 
need for additional funds.
    (3) Combined construction and nonconstruction projects. When a grant 
or subgrant provides funding for both construction and nonconstruction 
activities, the grantee or subgrantee must obtain prior written approval 
from the awarding agency before making any fund or budget transfer from 
nonconstruction to construction or vice versa.
    (d) Programmatic changes. Grantees or subgrantees must obtain the 
prior approval of the awarding agency whenever any of the following 
actions is anticipated:
    (1) Any revision of the scope or objectives of the project 
(regardless of whether there is an associated budget revision requiring 
prior approval).
    (2) Need to extend the period of availability of funds.
    (3) Changes in key persons in cases where specified in an 
application or a grant award. In research projects, a change in the 
project director or principal investigator shall always require approval 
unless waived by the awarding agency.
    (4) Under nonconstruction projects, contracting out, subgranting (if 
authorized by law) or otherwise obtaining the services of a third party 
to perform activities which are central to the purposes of the award. 
This approval requirement is in addition to the approval requirements of 
Sec. 1403.36 but does not apply to the procurement of equipment, 
supplies, and general support services.
    (e) Additional prior approval requirements. The awarding agency may 
not require prior approval for any budget revision which is not 
described in paragraph (c) of this section.
    (f) Requesting prior approval. (1) A request for prior approval of 
any budget revision will be in the same budget format the grantee used 
in its application and shall be accompanied by a narrative justification 
for the proposed revision.
    (2) A request for a prior approval under the applicable Federal cost 
principles (see Sec. 1403.22) may be made by letter.
    (3) A request by a subgrantee for prior approval will be addressed 
in writing to the grantee. The grantee will promptly review such request 
and shall approve or disapprove the request in writing. A grantee will 
not approve any budget or project revision which is inconsistent with 
the purpose or terms and conditions of the Federal grant to the grantee. 
If the revision requested by the subgrantee would result in a change to 
the grantee's approved project which requires Federal prior approval, 
the grantee will obtain the Federal agency's approval before approving 
the subgrantee's request.



Sec. 1403.31  Real property.

    (a) Title. Subject to the obligations and conditions set forth in 
this section, title to real property acquired under a grant or subgrant 
will vest upon acquisition in the grantee or subgrantee respectively.
    (b) Use. Except as otherwise provided by Federal statutes, real 
property will be used for the originally authorized purposes as long as 
needed for those purposes, and the grantee or subgrantee shall not 
dispose of or encumber its title or other interests.
    (c) Disposition. When real property is no longer needed for the 
originally authorized purpose, the grantee or subgrantee will request 
disposition instructions from the awarding agency. The instructions will 
provide for one of the following alternatives:
    (1) Retention of title. Retain title after compensating the awarding 
agency. The amount paid to the awarding agency will be computed by 
applying the awarding agency's percentage of participation in the cost 
of the original purchase to the fair market value of the property. 
However, in those situations were a grantee or subgrantee is disposing 
of real property acquired with grant funds and acquiring replacement 
real property under the same program, the net proceeds from the 
disposition may be used as an offset to the cost of the replacement 
property.
    (2) Sale of property. Sell the property and compensate the awarding 
agency.

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The amount due to the awarding agency will be calculated by applying the 
awarding agency's percentage of participation in the cost of the 
original purchase to the proceeds of the sale after deduction of any 
actual and reasonable selling and fixing-up expenses. If the grant is 
still active, the net proceeds from sale may be offset against the 
original cost of the property. When a grantee or subgrantee is directed 
to sell property, sales procedures shall be followed that provide for 
competition to the extent practicable and result in the highest possible 
return.
    (3) Transfer of title. Transfer title to the awarding agency or to a 
third-party designated/approved by the awarding agency. The grantee or 
subgrantee shall be paid an amount calculated by applying the grantee or 
subgrantee's percentage of participation in the purchase of the real 
property to the current fair market value of the property.



Sec. 1403.32  Equipment.

    (a) Title. Subject to the obligations and conditions set forth in 
this section, title to equipment acquired under a grant or subgrant will 
vest upon acquisition in the grantee or subgrantee respectively.
    (b) States. A State will use, manage, and dispose of equipment 
acquired under a grant by the State in accordance with State laws and 
procedures. Other grantees and subgrantees will follow paragraphs (c) 
through (e) of this section.
    (c) Use. (1) Equipment shall be used by the grantee or subgrantee in 
the program or project for which it was acquired as long as needed, 
whether or not the project or program continues to be supported by 
Federal funds. When no longer needed for the original program or 
project, the equipment may be used in other activities currently or 
previously supported by a Federal agency.
    (2) The grantee or subgrantee shall also make equipment available 
for use on other projects or programs currently or previously supported 
by the Federal Government, providing such use will not interfere with 
the work on the projects or program for which it was originally 
acquired. First preference for other use shall be given to other 
programs or projects supported by the awarding agency. User fees should 
be considered if appropriate.
    (3) Notwithstanding the encouragement in Sec. 1403.25(a) to earn 
program income, the grantee or subgrantee must not use equipment 
acquired with grant funds to provide services for a fee to compete 
unfairly with private companies that provide equivalent services, unless 
specifically permitted or contemplated by Federal statute.
    (4) When acquiring replacement equipment, the grantee or subgrantee 
may use the equipment to be replaced as a trade-in or sell the property 
and use the proceeds to offset the cost of the replacement property, 
subject to the approval of the awarding agency.
    (d) Management requirements. Procedures for managing equipment 
(including replacement equipment), whether acquired in whole or in part 
with grant funds, until disposition takes place will, as a minimum, meet 
the following requirements:
    (1) Property records must be maintained that include a description 
of the property, a serial number or other identification number, the 
source of property, who holds title, the acquisition date, and cost of 
the property, percentage of Federal participation in the cost of the 
property, the location, use and condition of the property, and any 
ultimate disposition data including the date of disposal and sale price 
of the property.
    (2) A physical inventory of the property must be taken and the 
results reconciled with the property records at least once every two 
years.
    (3) A control system must be developed to ensure adequate safeguards 
to prevent loss, damage, or theft of the property. Any loss, damage, or 
theft shall be investigated.
    (4) Adequate maintenance procedures must be developed to keep the 
property in good condition.
    (5) If the grantee or subgrantee is authorized or required to sell 
the property, proper sales procedures must be established to ensure the 
highest possible return.
    (e) Disposition. When original or replacement equipment acquired 
under a grant or subgrant is no longer needed

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for the original project or program or for other activities currently or 
previously supported by a Federal agency, disposition of the equipment 
will be made as follows:
    (1) Items of equipment with a current per-unit fair market value of 
less than $5,000 may be retained, sold or otherwise disposed of with no 
further obligation to the awarding agency.
    (2) Items of equipment with a current per unit fair market value in 
excess of $5,000 may be retained or sold and the awarding agency shall 
have a right to an amount calculated by multiplying the current market 
value or proceeds from sale by the awarding agency's share of the 
equipment.
    (3) In cases where a grantee or subgrantee fails to take appropriate 
disposition actions, the awarding agency may direct the grantee or 
subgrantee to take excess and disposition actions.
    (f) Federal equipment. In the event a grantee or subgrantee is 
provided federally-owned equipment:
    (1) Title will remain vested in the Federal Government.
    (2) Grantees or subgrantees will manage the equipment in accordance 
with Federal agency rules and procedures, and submit an annual inventory 
listing.
    (3) When the equipment is no longer needed, the grantee or 
subgrantee will request disposition instructions from the Federal 
agency.
    (g) Right to transfer title. The Federal awarding agency may reserve 
the right to transfer title to the Federal Government or a third party 
named by the awarding agency when such a third party is otherwise 
eligible under existing statutes. Such transfers shall be subject to the 
following standards:
    (1) The property shall be identified in the grant or otherwise made 
known to the grantee in writing.
    (2) The Federal awarding agency shall issue disposition instruction 
within 120 calendar days after the end of the Federal support of the 
project for which it was acquired. If the federal awarding agency fails 
to issue disposition instructions within the 120 calendar-day period the 
grantee shall follow Sec. 1403.32(e).
    (3) When title to equipment is transferred, the grantee shall be 
paid an amount calculated by applying the percentage of participation in 
the purchase to the current fair market value of the property.



Sec. 1403.33  Supplies.

    (a) Title. Title to supplies acquired under a grant or subgrant will 
vest, upon acquisition, in the grantee or subgrantee respectively.
    (b) Disposition. If there is a residual inventory of unused supplies 
exceeding $5,000 in total aggregate fair market value upon termination 
or completion of the award, and if the supplies are not needed for any 
other federally sponsored programs or projects, the grantee or 
subgrantee shall compensate the awarding agency for its share.



Sec. 1403.34  Copyrights.

    The Federal awarding agency reserves a royalty-free, nonexclusive, 
and irrevocable license to reproduce, publish or otherwise use, and to 
authorize others to use, for Federal Government purposes:
    (a) The copyright in any work developed under a grant, subgrant, or 
contract under a grant or subgrant; and
    (b) Any rights of copyright to which a grantee, subgrantee or a 
contractor purchases ownership with grant support.



Sec. 1403.35  Subawards to debarred and suspended parties.

    Grantees and subgrantees must not make any award or permit any award 
(subgrant or contract) at any tier to any party which is debarred or 
suspended or is otherwise excluded from or ineligible for participation 
in Federal assistance programs under Executive Order 12549, ``Debarment 
and Suspension.''



Sec. 1403.36  Procurement.

    (a) States. When procuring property and services under a grant, a 
State will follow the same policies and procedures it uses for 
procurements from its non-Federal funds. The State will ensure that 
every purchase order or other contract includes any clauses required by 
Federal statutes and executive orders and their implementing 
regulations. Other grantees and subgrantees will

[[Page 267]]

follow paragraphs (b) through (i) of this section.
    (b) Procurement standards. (1) Grantees and subgrantees will use 
their own procurement procedures which reflect applicable State and 
local laws and regulations, provided that the procurements conform to 
applicable Federal law and the standards identified in this section.
    (2) Grantees and subgrantees will maintain a contract administration 
system which ensures that contractors perform in accordance with the 
terms, conditions, and specifications of their contracts or purchase 
orders.
    (3) Grantees and subgrantees will maintain a written code of 
standards of conduct governing the performance of their employees 
engaged in the award and administration of contracts. No employee, 
officer or agent of the grantee or subgrantee shall participate in 
selection, or in the award or administration of a contract supported by 
Federal funds if a conflict of interest, real or apparent, would be 
involved. Such a conflict would arise when:
    (i) The employee, officer or agent,
    (ii) Any member of his immediate family,
    (iii) His or her partner, or
    (iv) An organization which employs, or is about to employ, any of 
the above, has a financial or other interest in the firm selected for 
award. The grantee's or subgrantee's officers, employees or agents will 
neither solicit nor accept gratuities, favors or anything of monetary 
value from contractors, potential contractors, or parties to 
subagreements. Grantee and subgrantees may set minimum rules where the 
financial interest is not substantial or the gift is an unsolicited item 
of nominal intrinsic value. To the extent permitted by State or local 
law or regulations, such standards or conduct will provide for 
penalties, sanctions, or other disciplinary actions for violations of 
such standards by the grantee's and subgrantee's officers, employees, or 
agents, or by contractors or their agents. The awarding agency may in 
regulation provide additional prohibitions relative to real, apparent, 
or potential conflicts of interest.
    (4) Grantee and subgrantee procedures will provide for a review of 
proposed procurements to avoid purchase of unnecessary or duplicative 
items. Consideration should be given to consolidating or breaking out 
procurements to obtain a more economical purchase. Where appropriate, an 
analysis will be made of lease versus purchase alternatives, and any 
other appropriate analysis to determine the most economical approach.
    (5) To foster greater economy and efficiency, grantees and 
subgrantees are encouraged to enter into State and local 
intergovernmental agreements for procurement or use of common goods and 
services.
    (6) Grantees and subgrantees are encouraged to use Federal excess 
and surplus property in lieu of purchasing new equipment and property 
whenever such use is feasible and reduces project costs.
    (7) Grantees and subgrantees are encouraged to use value engineering 
clauses in contracts for construction projects of sufficient size to 
offer reasonable opportunities for cost reductions. Value engineering is 
a systematic and creative analysis of each contract item or task to 
ensure that its essential function is provided at the overall lower 
cost.
    (8) Grantees and subgrantees will make awards only to responsible 
contractors possessing the ability to perform successfully under the 
terms and conditions of a proposed procurement. Consideration will be 
given to such matters as contractor integrity, compliance with public 
policy, record of past performance, and financial and technical 
resources.
    (9) Grantees and subgrantees will maintain records sufficient to 
detail the significant history of a procurement. These records will 
include, but are not necessarily limited to the following: rationale for 
the method of procurement, selection of contract type, contractor 
selection or rejection, and the basis for the contract price.
    (10) Grantees and subgrantees will use time and material type 
contracts only--
    (i) After a determination that no other contract is suitable, and
    (ii) If the contract includes a ceiling price that the contractor 
exceeds at its own risk.

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    (11) Grantees and subgrantees alone will be responsible, in 
accordance with good administrative practice and sound business 
judgment, for the settlement of all contractual and administrative 
issues arising out of procurements. These issues include, but are not 
limited to source evaluation, protests, disputes, and claims. These 
standards do not relieve the grantee or subgrantee of any contractual 
responsibilities under its contracts. Federal agencies will not 
substitute their judgment for that of the grantee or subgrantee unless 
the matter is primarily a Federal concern. Violations of law will be 
referred to the local, State, or Federal authority having proper 
jurisdiction.
    (12) Grantees and subgrantees will have protest procedures to handle 
and resolve disputes relating to their procurements and shall in all 
instances disclose information regarding the protest to the awarding 
agency. A protestor must exhaust all administrative remedies with the 
grantee and subgrantee before pursuing a protest with the Federal 
agency. Reviews of protests by the Federal agency will be limited to:
    (i) Violations of Federal law or regulations and the standards of 
this section (violations of State or local law will be under the 
jurisdiction of State or local authorities) and
    (ii) Violations of the grantee's or subgrantee's protest procedures 
for failure to review a complaint or protest. Protests received by the 
Federal agency other than those specified above will be referred to the 
grantee or subgrantee.
    (c) Competition. (1) All procurement transactions will be conducted 
in a manner providing full and open competition consistent with the 
standards of Sec. 1403.36. Some of the situations considered to be 
restrictive of competition include but are not limited to:
    (i) Placing unreasonable requirements on firms in order for them to 
qualify to do business,
    (ii) Requiring unnecessary experience and excessive bonding,
    (iii) Noncompetitive pricing practices between firms or between 
affiliated companies,
    (iv) Noncompetitive awards to consultants that are on retainer 
contracts,
    (v) Organizational conflicts of interest,
    (vi) Specifying only a ``brand name'' product instead of allowing 
``an equal'' product to be offered and describing the performance of 
other relevant requirements of the procurement, and
    (vii) Any arbitrary action in the procurement process.
    (2) Grantees and subgrantees will conduct procurements in a manner 
that prohibits the use of statutorily or administratively imposed in-
State or local geographical preferences in the evaluation of bids or 
proposals, except in those cases where applicable Federal statutes 
expressly mandate or encourage geographic preference. Nothing in this 
section preempts State licensing laws. When contracting for 
architectural and engineering (A/E) services, geographic location may be 
a selection criteria provided its application leaves an appropriate 
number of qualified firms, given the nature and size of the project, to 
compete for the contract.
    (3) Grantees will have written selection procedures for procurement 
transactions. These procedures will ensure that all solicitations:
    (i) Incorporate a clear and accurate description of the technical 
requirements for the material, product, or service to be procured. Such 
description shall not, in competitive procurements, contain features 
which unduly restrict competition. The description may include a 
statement of the qualitative nature of the material, product or service 
to be procured, and when necessary, shall set forth those minimum 
essential characteristics and standards to which it must conform if it 
is to satisfy its intended use. Detailed product specifications should 
be avoided if at all possible. When it is impractical or uneconomical to 
make a clear and accurate description of the technical requirements, a 
``brand name or equal'' description may be used as a means to define the 
performance or other salient requirements of a procurement. The specific 
features of the named brand which must be met by offerors shall be 
clearly stated; and
    (ii) Identify all requirements which the offerors must fulfill and 
all other factors to be used in evaluating bids or proposals.

[[Page 269]]

    (4) Grantees and subgrantees will ensure that all prequalified lists 
of persons, firms, or products which are used in acquiring goods and 
services are current and include enough qualified sources to ensure 
maximum open and free competition. Also, grantees and subgrantees will 
not preclude potential bidders from qualifying during the solicitation 
period.
    (d) Methods of procurement to be followed. (1) Procurement by small 
purchase procedures. Small purchase procedures are those relatively 
simple and informal procurement methods for securing services, supplies, 
or other property that do not cost more than the simplified acquisition 
threshold fixed at 41 U.S.C. 403(11) (currently set at $100,000). If 
small purchase procedures are used, price or rate quotations shall be 
obtained from an adequate number of qualified sources.
    (2) Procurement by sealed bids (formal advertising). Bids are 
publicly solicited and a firm-fixed-price contract (lump sum or unit 
price) is awarded to the responsible bidder whose bid, conforming with 
all the material terms and conditions of the invitation for bids, is the 
lowest in price. The sealed bid method is the preferred method for 
procuring construction, if the conditions in Sec. 1403.36(d)(2)(i) 
apply.
    (i) In order for sealed bidding to be feasible, the following 
conditions should be present:
    (A) A complete, adequate, and realistic specification or purchase 
description is available;
    (B) Two or more responsible bidders are willing and able to compete 
effectively and for the business; and
    (C) The procurement lends itself to a firm fixed price contract and 
the selection of the successful bidder can be made principally on the 
basis of price.
    (ii) If sealed bids are used, the following requirements apply:
    (A) The invitation for bids will be publicly advertised and bids 
shall be solicited from an adequate number of known suppliers, providing 
them sufficient time prior to the date set for opening the bids;
    (B) The invitation for bids, which will include any specifications 
and pertinent attachments, shall define the items or services in order 
for the bidder to properly respond;
    (C) All bids will be publicly opened at the time and place 
prescribed in the invitation for bids;
    (D) A firm fixed-price contract award will be made in writing to the 
lowest responsive and responsible bidder. Where specified in bidding 
documents, factors such as discounts, transportation cost, and life 
cycle costs shall be considered in determining which bid is lowest. 
Payment discounts will only be used to determine the low bid when prior 
experience indicates that such discounts are usually taken advantage of; 
and
    (E) Any or all bids may be rejected if there is a sound documented 
reason.
    (3) Procurement by competitive proposals. The technique of 
competitive proposals is normally conducted with more than one source 
submitting an offer, and either a fixed-price or cost-reimbursement type 
contract is awarded. It is generally used when conditions are not 
appropriate for the use of sealed bids. If this method is used, the 
following requirements apply:
    (i) Requests for proposals will be publicized and identify all 
evaluation factors and their relative importance. Any response to 
publicized requests for proposals shall be honored to the maximum extent 
practical;
    (ii) Proposals will be solicited from an adequate number of 
qualified sources;
    (iii) Grantees and subgrantees will have a method for conducting 
technical evaluations of the proposals received and for selecting 
awardees;
    (iv) Awards will be made to the responsible firm whose proposal is 
most advantageous to the program, with price and other factors 
considered; and
    (v) Grantees and subgrantees may use competitive proposal procedures 
for qualifications-based procurement of architectural/engineering (A/E) 
professional services whereby competitors' qualifications are evaluated 
and the most qualified competitor is selected, subject to negotiation of 
fair and reasonable compensation. The method, where price is not used as 
a selection factor, can only be used in procurement of A/E professional 
services. It cannot be used to purchase other types

[[Page 270]]

of services though A/E firms are a potential source to perform the 
proposed effort.
    (4) Procurement by noncompetitive proposals is procurement through 
solicitation of a proposal from only one source, or after solicitation 
of a number of sources, competition is determined inadequate.
    (i) Procurement by noncompetitive proposals may be used only when 
the award of a contract is infeasible under small purchase procedures, 
sealed bids or competitive proposals and one of the following 
circumstances applies:
    (A) The item is available only from a single source;
    (B) The public exigency or emergency for the requirement will not 
permit a delay resulting from competitive solicitation;
    (C) The awarding agency authorizes noncompetitive proposals; or
    (D) After solicitation of a number of sources, competition is 
determined inadequate.
    (ii) Cost analysis, i.e., verifying the proposed cost data, the 
projections of the data, and the evaluation of the specific elements of 
costs and profits, is required.
    (iii) Grantees and subgrantees may be required to submit the 
proposed procurement to the awarding agency for pre-award review in 
accordance with paragraph (g) of this section.
    (e) Contracting with small and minority firms, women's business 
enterprise and labor surplus area firms. (1) The grantee and subgrantee 
will take all necessary affirmative steps to assure that minority firms, 
women's business enterprises, and labor surplus area firms are used when 
possible.
    (2) Affirmative steps shall include:
    (i) Placing qualified small and minority businesses and women's 
business enterprises on solicitation lists;
    (ii) Assuring that small and minority businesses, and women's 
business enterprises are solicited whenever they are potential sources;
    (iii) Dividing total requirements, when economically feasible, into 
smaller tasks or quantities to permit maximum participation by small and 
minority business, and women's business enterprises;
    (iv) Establishing delivery schedules, where the requirement permits, 
which encourage participation by small and minority business, and 
women's business enterprises;
    (v) Using the services and assistance of the Small Business 
Administration, and the Minority Business Development Agency of the 
Department of Commerce; and
    (vi) Requiring the prime contractor, if subcontracts are to be let, 
to take the affirmative steps listed in paragraphs (e)(2) (i) through 
(v) of this section.
    (f) Contract cost and price. (1) Grantees and subgrantees must 
perform a cost or price analysis in connection with every procurement 
action including contract modifications. The method and degree of 
analysis is dependent on the facts surrounding the particular 
procurement situation, but as a starting point, grantees must make 
independent estimates before receiving bids or proposals. A cost 
analysis must be performed when the offeror is required to submit the 
elements of his estimated cost, e.g., under professional, consulting, 
and architectural engineering services contracts. A cost analysis will 
be necessary when adequate price competition is lacking, and for sole 
source procurements, including contract modifications or change orders, 
unless price reasonableness can be established on the basis of a catalog 
or market price of a commercial product sold in substantial quantities 
to the general public or based on prices set by law or regulation. A 
price analysis will be used in all other instances to determine the 
reasonableness of the proposed contract price.
    (2) Grantees and subgrantees will negotiate profit as a separate 
element of the price for each contract in which there is no price 
competition and in all cases where cost analysis is performed. To 
establish a fair and reasonable profit, consideration will be given to 
the complexity of the work to be performed, the risk borne by the 
contractor, the contractor's investment, the amount of subcontracting, 
the quality of its record of past performance, and industry profit rates 
in the surrounding geographical area for similar work.

[[Page 271]]

    (3) Costs or prices based on estimated costs for contracts under 
grants will be allowable only to the extent that costs incurred or cost 
estimates included in negotiated prices are consistent with Federal cost 
principles (see Sec. 1403.22). Grantees may reference their own cost 
principles that comply with the applicable Federal cost principles.
    (4) The cost plus a percentage of cost and percentage of 
constructing cost methods of contracting shall not be used.
    (g) Awarding agency review. (1) Grantees and subgrantees must make 
available, upon request of the awarding agency, technical specifications 
on proposed procurements where the awarding agency believes such review 
is needed to ensure that the item and/or service specified is the one 
being proposed for purchase. This review generally will take place prior 
to the time the specification is incorporated into a solicitation 
document. However, if the grantee or subgrantee desires to have the 
review accomplished after a solicitation has been developed, the 
awarding agency may still review the specifications, with such review 
usually limited to the technical aspects of the proposed purchase.
    (2) Grantees and subgrantees must on request make available for 
awarding agency pre-award review procurement documents, such as requests 
for proposals or invitations for bids, independent cost estimates, etc. 
when:
    (i) A grantee's or subgrantee's procurement procedures or operation 
fails to comply with the procurement standards in this section; or
    (ii) The procurement is expected to exceed the simplified 
acquisition threshold and is to be awarded without competition or only 
one bid or offer is received in response to a solicitation; or
    (iii) The procurement, which is expected to exceed the simplified 
acquisition threshold, specifies a ``brand name'' product; or
    (iv) The proposed award is more than the simplified acquisition 
threshold and is to be awarded to other than the apparent low bidder 
under a sealed bid procurement; or
    (v) A proposed contract modification changes the scope of a contract 
or increases the contract amount by more than the simplified acquisition 
threshold.
    (3) A grantee or subgrantee will be exempt from the pre-award review 
in paragraph (g)(2) of this section if the awarding agency determines 
that its procurement systems comply with the standards of this section.
    (i) A grantee or subgrantee may request that its procurement system 
be reviewed by the awarding agency to determine whether its system meets 
these standards in order for its system to be certified. Generally, 
these reviews shall occur where there is a continuous high-dollar 
funding, and third-party contracts are awarded on a regular basis.
    (ii) A grantee or subgrantee may self-certify its procurement 
system. Such self-certification shall not limit the awarding agency's 
right to survey the system. Under a self-certification procedure, 
awarding agencies may wish to rely on written assurances from the 
grantee or subgrantee that it is complying with these standards. A 
grantee or subgrantee will cite specific procedures, regulations, 
standards, etc., as being in compliance with these requirements and have 
its system available for review.
    (h) Bonding requirements. For construction or facility improvement 
contracts or subcontracts exceeding the simplified acquisition 
threshold, the awarding agency may accept the bonding policy and 
requirements of the grantee or subgrantee provided the awarding agency 
has made a determination that the awarding agency's interest is 
adequately protected. If such a determination has not been made, the 
minimum requirements shall be as follows:
    (1) A bid guarantee from each bidder equivalent to five percent of 
the bid price. The ``bid guarantee'' shall consist of a firm commitment 
such as a bid bond, certified check, or other negotiable instrument 
accompanying a bid as assurance that the bidder will, upon acceptance of 
his bid, execute such contractual documents as may be required within 
the time specified.
    (2) A performance bond on the part of the contractor for 100 percent 
of the contract price. A ``performance bond'' is

[[Page 272]]

one executed in connection with a contract to secure fulfillment of all 
the contractor's obligations under such contract.
    (3) A payment bond on the part of the contractor for 100 percent of 
the contract price. A ``payment bond'' is one executed in connection 
with a contract to assure payment as required by law of all persons 
supplying labor and material in the execution of the work provided for 
in the contract.
    (i) Contract provisions. A grantee's and subgrantee's contracts must 
contain provisions in paragraph (i) of this section. Federal agencies 
are permitted to require changes, remedies, changed conditions, access 
and records retention, suspension of work, and other clauses approved by 
the Office of Federal Procurement Policy.
    (1) Administrative, contractual, or legal remedies in instances 
where contractors violate or breach contract terms, and provide for such 
sanctions and penalties as may be appropriate. (Contracts more than the 
simplified acquisition threshold)
    (2) Termination for cause and for convenience by the grantee or 
subgrantee including the manner by which it will be effected and the 
basis for settlement. (All contracts in excess of $10,000)
    (3) Compliance with Executive Order 11246 of September 24, 1965, 
entitled ``Equal Employment Opportunity,'' as amended by Executive Order 
11375 of October 13, 1967, and as supplemented in Department of Labor 
regulations (41 CFR chapter 60). (All construction contracts awarded in 
excess of $10,000 by grantees and their contractors or subgrantees)
    (4) Compliance with the Copeland ``Anti-Kickback'' Act (18 U.S.C. 
874) as supplemented in Department of Labor regulations (29 CFR Part 3). 
(All contracts and subgrants for construction or repair)
    (5) Compliance with the Davis-Bacon Act (40 U.S.C. 276a to 276a-7) 
as supplemented by Department of Labor regulations (29 CFR Part 5). 
(Construction contracts in excess of $2000 awarded by grantees and 
subgrantees when required by Federal grant program legislation)
    (6) Compliance with Sections 103 and 107 of the Contract Work Hours 
and Safety Standards Act (40 U.S.C. 327-330) as supplemented by 
Department of Labor regulations (29 CFR Part 5). (Construction contracts 
awarded by grantees and subgrantees in excess of $2000, and in excess of 
$2500 for other contracts which involve the employment of mechanics or 
laborers)
    (7) Notice of awarding agency requirements and regulations 
pertaining to reporting.
    (8) Notice of awarding agency requirements and regulations 
pertaining to patent rights with respect to any discovery or invention 
which arises or is developed in the course of or under such contract.
    (9) Awarding agency requirements and regulations pertaining to 
copyrights and rights in data.
    (10) Access by the grantee, the subgrantee, the Federal grantor 
agency, the Comptroller General of the United States, or any of their 
duly authorized representatives to any books, documents, papers, and 
records of the contractor which are directly pertinent to that specific 
contract for the purpose of making audit, examination, excerpts, and 
transcriptions.
    (11) Retention of all required records for three years after 
grantees or subgrantees make final payments and all other pending 
matters are closed.
    (12) Compliance with all applicable standards, orders, or 
requirements issued under section 306 of the Clean Air Act (42 U.S.C. 
1857(h)), section 508 of the Clean Water Act (33 U.S.C. 1368), Executive 
Order 11738, and Environmental Protection Agency regulations (40 CFR 
part 15). (Contracts, subcontracts, and subgrants of amounts in excess 
of $100,000).
    (13) Mandatory standards and policies relating to energy efficiency 
which are contained in the state energy conservation plan issued in 
compliance with the Energy Policy and Conservation Act (Pub. L. 94-163, 
89 Stat. 871).

[57 FR 55092, Nov. 24, 1992, as amended at 60 FR 19639, 19642, Apr. 19, 
1995]



Sec. 1403.37  Subgrants.

    (a) States. States shall follow state law and procedures when 
awarding and administering subgrants (whether on a

[[Page 273]]

cost reimbursement or fixed amount basis) of financial assistance to 
local and Indian tribal governments. States shall:
    (1) Ensure that every subgrant includes any clauses required by 
Federal statute and executive orders and their implementing regulations;
    (2) Ensure that subgrantees are aware of requirements imposed upon 
them by Federal statute and regulation;
    (3) Ensure that a provision for compliance with Sec. 1403.42 is 
placed in every cost reimbursement subgrant; and
    (4) Conform any advances of grant funds to subgrantees substantially 
to the same standards of timing and amount that apply to cash advances 
by Federal agencies.
    (b) All other grantees. All other grantees shall follow the 
provisions of this part which are applicable to awarding agencies when 
awarding and administering subgrants (whether on a cost reimbursement or 
fixed amount basis) of financial assistance to local and Indian tribal 
governments. Grantees shall:
    (1) Ensure that every subgrant includes a provision for compliance 
with this part;
    (2) Ensure that every subgrant includes any clauses required by 
Federal statute and executive orders and their implementing regulations; 
and
    (3) Ensure that subgrantees are aware of requirements imposed upon 
them by Federal statutes and regulations.
    (c) Exceptions. By their own terms, certain provisions of this part 
do not apply to the award and administration of subgrants:
    (1) Section 1403.10;
    (2) Section 1403.11;
    (3) The letter-of-credit procedures specified in Treasury 
Regulations at 31 CFR part 205, cited in Sec. 1403.21; and
    (4) Section 1403.50.

              Reports, Records, Retention, and Enforcement



Sec. 1403.40  Monitoring and reporting program performance.

    (a) Monitoring by grantees. Grantees are responsible for managing 
the day-to-day operations of grant and subgrant supported activities. 
Grantees must monitor grant and subgrant supported activities to assure 
compliance with applicable Federal requirements and that performance 
goals are being achieved. Grantee monitoring must cover each program, 
function or activity.
    (b) Nonconstruction performance reports. The Federal agency may, if 
it decides that performance information available from subsequent 
applications contains sufficient information to meet its programmatic 
needs, require the grantee to submit a performance report only upon 
expiration or termination of grant support. Unless waived by the Federal 
agency this report will be due on the same date as the final Financial 
Status Report.
    (1) Grantees shall submit annual performance reports unless the 
awarding agency requires quarterly or semi-annual reports. However, 
performance reports will not be required more frequently than quarterly. 
Annual reports shall be due 90 days after the grant year, quarterly or 
semi-annual reports shall be due 30 days after the reporting period. The 
final performance report will be due 90 days after the expiration or 
termination of grant support. If a justified request is submitted by a 
grantee, the Federal agency may extend the due date for any performance 
report. Additionally, requirements for unnecessary performance reports 
may be waived by the Federal agency.
    (2) Performance reports will contain, for each grant, brief 
information on the following:
    (i) A comparison of actual accomplishments to the objectives 
established for the period. Where the output of the project can be 
quantified, a computation of the cost per unit of output may be required 
if that information will be useful.
    (ii) The reasons for slippage if established objectives were not 
met.
    (iii) Additional pertinent information including, when appropriate, 
analysis and explanation of cost overruns or high unit costs.
    (3) Grantees will not be required to submit more than the original 
and two copies of performance reports.

[[Page 274]]

    (4) Grantees will adhere to the standards in this section in 
prescribing performance reporting requirements for subgrantees.
    (c) Construction performance reports. For the most part, on-site 
technical inspections and certified percentage-of-completion data are 
relied on heavily by Federal agencies to monitor progress under 
construction grants and subgrants. The Federal agency will require 
additional formal performance reports only when considered necessary, 
and never more frequently than quarterly.
    (d) Significant developments. Events may occur between the scheduled 
performance reporting dates which have significant impact upon the grant 
or subgrant supported activity. In such cases, the grantee must inform 
the Federal agency as soon as the following types of conditions become 
known:
    (1) Problems, delays, or adverse conditions which will materially 
impair the ability to meet the objective of the award. This disclosure 
must include a statement of the action taken, or contemplated, and any 
assistance needed to resolve the situation.
    (2) Favorable developments which enable meeting time schedules and 
objectives sooner or at less cost than anticipated or producing more 
beneficial results than originally planned.
    (e) Federal agencies may make site visits as warranted by program 
needs.
    (f) Waivers, extensions. (1) Federal agencies may waive any 
performance report required by this part if not needed.
    (2) The grantee may waive any performance report from a subgrantee 
when not needed. The grantee may extend the due date for any performance 
report from a subgrantee if the grantee will still be able to meet its 
performance reporting obligations to the Federal agency.



Sec. 1403.41  Financial reporting.

    (a) General. (1) Except as provided in paragraphs (a) (2) and (5) of 
this section, grantees will use only the forms specified in paragraphs 
(a) through (e) of this section, and such supplementary or other forms 
as may from time to time be authorized by OMB, for:
    (i) Submitting financial reports to Federal agencies, or
    (ii) Requesting advances or reimbursements when letters of credit 
are not used.
    (2) Grantees need not apply the forms prescribed in this section in 
dealing with their subgrantees. However, grantees shall not impose more 
burdensome requirements on subgrantees.
    (3) Grantees shall follow all applicable standard and supplemental 
Federal agency instructions approved by OMB to the extent required under 
the Paperwork Reduction Act of 1980 for use in connection with forms 
specified in paragraphs (b) through (e) of this section. Federal 
agencies may issue substantive supplementary instructions only with the 
approval of OMB. Federal agencies may shade out or instruct the grantee 
to disregard any line item that the Federal agency finds unnecessary for 
its decision making purposes.
    (4) Grantees will not be required to submit more than the original 
and two copies of forms required under this part.
    (5) Federal agencies may provide computer outputs to grantees to 
expedite or contribute to the accuracy of reporting. Federal agencies 
may accept the required information from grantees in machine usable 
format or computer printouts instead of prescribed forms.
    (6) Federal agencies may waive any report required by this section 
if not needed.
    (7) Federal agencies may extend the due date of any financial report 
upon receiving a justified request from a grantee.
    (b) Financial Status Report(1) Form. Grantees will use Standard Form 
269 or 269A, Financial Status Report, to report the status of funds for 
all nonconstruction grants and for construction grants when required in 
accordance with paragraph Sec. 1403.41(e)(2)(iii) of this section.
    (2) Accounting basis. Each grantee will report program outlays and 
program income on a cash or accrual basis as prescribed by the awarding 
agency. If the Federal agency requires accrual information and the 
grantee's accounting records are not normally kept on the accrual basis, 
the grantee shall not be

[[Page 275]]

required to convert its accounting system but shall develop such accrual 
information through an analysis of the documentation on hand.
    (3) Frequency. The Federal agency may prescribe the frequency of the 
report for each project or program. However, the report will not be 
required more frequently than quarterly. If the Federal agency does not 
specify the frequency of the report, it will be submitted annually. A 
final report will be required upon expiration or termination of grant 
support.
    (4) Due date. When reports are required on a quarterly or semiannual 
basis, they will be due 30 days after the reporting period. When 
required on an annual basis, they will be due 90 days after the grant 
year. Final reports will be due 90 days after the expiration or 
termination of grant support.
    (c) Federal Cash Transactions Report--(1) Form. (i) For grants paid 
by letter of credit, Treasury check advances or electronic transfer of 
funds, the grantee will submit the Standard Form 272, Federal Cash 
Transactions Report, and when necessary, its continuation sheet, 
Standard Form 272a, unless the terms of the award exempt the grantee 
from this requirement.
    (ii) These reports will be used by the Federal agency to monitor 
cash advanced to grantees and to obtain disbursement or outlay 
information for each grant from grantees. The format of the report may 
be adapted as appropriate when reporting is to be accomplished with the 
assistance of automatic data processing equipment provided that the 
information to be submitted is not changed in substance.
    (2) Forecasts of Federal cash requirements. Forecasts of Federal 
cash requirements may be required in the ``Remarks'' section of the 
report.
    (3) Cash in hands of subgrantees. When considered necessary and 
feasible by the Federal agency, grantees may be required to report the 
amount of cash advances in excess of three days' needs in the hands of 
their subgrantees or contractors and to provide short narrative 
explanations of actions taken by the grantee to reduce the excess 
balances.
    (4) Frequency and due date. Grantees must submit the report no later 
than 15 working days following the end of each quarter. However, where 
an advance either by letter of credit or electronic transfer of funds is 
authorized at an annualized rate of one million dollars or more, the 
Federal agency may require the report to be submitted within 15 working 
days following the end of each month.
    (d) Request for advance or reimbursement(1) Advance payments. 
Requests for Treasury check advance payments will be submitted on 
Standard Form 270, Request for Advance or Reimbursement. (This form will 
not be used for drawdowns under a letter of credit, electronic funds 
transfer or when Treasury check advance payments are made to the grantee 
automatically on a predetermined basis.)
    (2) Reimbursements. Requests for reimbursement under nonconstruction 
grants will also be submitted on Standard Form 270. (For reimbursement 
requests under construction grants, see paragraph (e)(1) of this 
section.)
    (3) The frequency for submitting payment requests is treated in 
Sec. 1403.41(b)(3).
    (e) Outlay report and request for reimbursement for construction 
programs(1) Grants that support construction activities paid by 
reimbursement method. (i) Requests for reimbursement under construction 
grants will be submitted on Standard Form 271, Outlay Report and Request 
for Reimbursement for Construction Programs. Federal agencies may, 
however, prescribe the Request for Advance or Reimbursement form, 
specified in Sec. 1403.41(d), instead of this form.
    (ii) The frequency for submitting reimbursement requests is treated 
in Sec. 1403.41(b)(3).
    (2) Grants that support construction activities paid by letter of 
credit, electronic funds transfer or Treasury check advance. (i) When a 
construction grant is paid by letter of credit, electronic funds 
transfer or Treasury check advances, the grantee will report its outlays 
to the Federal agency using Standard Form 271, Outlay Report and Request 
for Reimbursement for Construction Programs. The Federal agency will 
provide any necessary special instruction. However, frequency and

[[Page 276]]

due date shall be governed by Sec. 1403.41(b) (3) and (4).
    (ii) When a construction grant is paid by Treasury check advances 
based on periodic requests from the grantee, the advances will be 
requested on the form specified in Sec. 1403.41(d).
    (iii) The Federal agency may substitute the Financial Status Report 
specified in Sec. 1403.41(b) for the Outlay Report and Request for 
Reimbursement for Construction Programs.
    (3) Accounting basis. The accounting basis for the Outlay Report and 
Request for Reimbursement for Construction Programs shall be governed by 
Sec. 1403.41(b)(2).



Sec. 1403.42  Retention and access requirements for records.

    (a) Applicability. (1) This section applies to all financial and 
programmatic records, supporting documents, statistical records, and 
other records of grantees or subgrantees which are:
    (i) Required to be maintained by the terms of this Part, program 
regulations or the grant agreement, or
    (ii) Otherwise reasonably considered as pertinent to program 
regulations or the grant agreement.
    (2) This section does not apply to records maintained by contractors 
or subcontractors. For a requirement to place a provision concerning 
records in certain kinds of contracts, see Sec. 1403.36(i)(10).
    (b) Length of retention period. (1) Except as otherwise provided, 
records must be retained for three years from the starting date 
specified in paragraph (c) of this section.
    (2) If any litigation, claim, negotiation, audit or other action 
involving the records has been started before the expiration of the 3-
year period, the records must be retained until completion of the action 
and resolution of all issues which arise from it, or until the end of 
the regular 3-year period, whichever is later.
    (3) To avoid duplicate recordkeeping, awarding agencies may make 
special arrangements with grantees and subgrantees to retain any records 
which are continuously needed for joint use. The awarding agency will 
request transfer of records to its custody when it determines that the 
records possess long-term retention value. When the records are 
transferred to or maintained by the Federal agency, the 3-year retention 
requirement is not applicable to the grantee or subgrantees.
    (c) Starting date of retention period(1) General. When grant support 
is continued or renewed at annual or other intervals, the retention 
period for the records of each funding period starts on the day the 
grantee or subgrantee submits to the awarding agency its single or last 
expenditure report for that period. However, if grant support is 
continued or renewed quarterly, the retention period for each year's 
records starts on the day the grantee submits its expenditure report for 
the last quarter of the Federal fiscal year. In all other cases, the 
retention period starts on the day the grantee submits its final 
expenditure report. If an expenditure report has been waived, the 
retention period starts on the day the report would have been due.
    (2) Real property and equipment records. The retention period for 
real property and equipment records starts from the date of the 
disposition or replacement or transfer at the direction of the awarding 
agency.
    (3) Records for income transactions after grant or subgrant support. 
In some cases grantees must report income after the period of grant 
support. Where there is such a requirement, the retention period for the 
records pertaining to the earning of the income starts from the end of 
the grantee's fiscal year in which the income is earned.
    (4) Indirect cost rate proposals, cost allocations plans, etc. This 
paragraph applies to the following types of documents, and their 
supporting records: indirect cost rate computations or proposals, cost 
allocation plans, and any similar accounting computations of the rate at 
which a particular group of costs is chargeable (such as computer usage 
chargeback rates or composite fringe benefit rates).
    (i) If submitted for negotiation. If the proposal, plan, or other 
computation is required to be submitted to the Federal Government (or to 
the grantee) to form the basis for negotiation of the rate, then the 3-
year retention period for its supporting records starts from the date of 
such submission.

[[Page 277]]

    (ii) If not submitted for negotiation. If the proposal, plan, or 
other computation is not required to be submitted to the Federal 
Government (or to the grantee) for negotiation purposes, then the 3-year 
retention period for the proposal plan, or computation and its 
supporting records starts from end of the fiscal year (or other 
accounting period) covered by the proposal, plan, or other computation.
    (d) Substitution of microfilm. Copies made by microfilming, 
photocopying, or similar methods may be substituted for the original 
records.
    (e) Access to records(1) Records of grantees and subgrantees. The 
awarding agency and the Comptroller General of the United States, or any 
of their authorized representatives, shall have the right of access to 
any pertinent books, documents, papers, or other records of grantees and 
subgrantees which are pertinent to the grant, in order to make audits, 
examinations, excerpts, and transcripts.
    (2) Expiration of right of access. The rights of access in this 
section must not be limited to the required retention period but shall 
last as long as the records are retained.
    (f) Restrictions on public access. The Federal Freedom of 
Information Act (5 U.S.C. 552) does not apply to records. Unless 
required by Federal, State, or local law, grantees and subgrantees are 
not required to permit public access to their records.



Sec. 1403.43  Enforcement.

    (a) Remedies for noncompliance. If a grantee or subgrantee 
materially fails to comply with any term of an award, whether stated in 
a Federal statute or regulation, an assurance, in a State plan or 
application, a notice of award, or elsewhere, the awarding agency may 
take one or more of the following actions, as appropriate in the 
circumstances:
    (1) Temporarily withhold cash payments pending correction of the 
deficiency by the grantee or subgrantee or more severe enforcement 
action by the awarding agency,
    (2) Disallow (that is, deny both use of funds and matching credit 
for) all or part of the cost of the activity or action not in 
compliance,
    (3) Wholly or partly suspend or terminate the current award for the 
grantee's or subgrantee's program,
    (4) Withhold further awards for the program, or
    (5) Take other remedies that may be legally available.
    (b) Hearings, appeals. In taking an enforcement action, the awarding 
agency will provide the grantee or subgrantee an opportunity for such 
hearing, appeal, or other administrative proceeding to which the grantee 
or subgrantee is entitled under any statute or regulation applicable to 
the action involved.
    (c) Effects of suspension and termination. Costs of grantee or 
subgrantee resulting from obligations incurred by the grantee or 
subgrantee during a suspension or after termination of an award are not 
allowable unless the awarding agency expressly authorizes them in the 
notice of suspension or termination or subsequently. Other grantee or 
subgrantee costs during suspension or after termination which are 
necessary and not reasonably avoidable are allowable if:
    (1) The costs result from obligations which were properly incurred 
by the grantee or subgrantee before the effective date of suspension or 
termination, are not in anticipation of it, and, in the case of a 
termination, are noncancellable, and,
    (2) The costs would be allowable if the award were not suspended or 
expired normally at the end of the funding period in which the 
termination takes effect.
    (d) Relationship to Debarment and Suspension. The enforcement 
remedies identified in this section, including suspension and 
termination, do not preclude grantee or subgrantee from being subject to 
``Debarment and Suspension'' under E.O. 12549 (see Sec. 1403.35).



Sec. 1403.44  Termination for convenience.

    Except as provided in Sec. 1403.43 awards may be terminated in 
whole or in part only as follows:
    (a) By the awarding agency with the consent of the grantee or 
subgrantee in which case the two parties shall agree upon the 
termination conditions, including the effective date and in the

[[Page 278]]

case of partial termination, the portion to be terminated, or
    (b) By the grantee or subgrantee upon written notification to the 
awarding agency, setting forth the reasons for such termination, the 
effective date, and in the case of partial termination, the portion to 
be terminated. However, if, in the case of a partial termination, the 
awarding agency determines that the remaining portion of the award will 
not accomplish the purposes for which the award was made, the awarding 
agency may terminate the award in its entirety under either Sec. 
1403.43 or paragraph (a) of this section.



                 Subpart D_After-The-Grant Requirements



Sec. 1403.50  Closeout.

    (a) General. The Federal agency will close out the award when it 
determines that all applicable administrative actions and all required 
work of the grant has been completed.
    (b) Reports. Within 90 days after the expiration or termination of 
the grant, the grantee must submit all financial, performance, and other 
reports required as a condition of the grant. Upon request by the 
grantee, Federal agencies may extend this time frame. These may include 
but are not limited to:
    (1) Final performance or progress report.
    (2) Financial Status Report (SF 269) or Outlay Report and Request 
for Reimbursement for Construction Programs (SF-271) (as applicable).
    (3) Final request for payment (SF-270) (if applicable).
    (4) Invention disclosure (if applicable).
    (5) Federally-owned property report: In accordance with Sec. 
1403.32(f), a grantee must submit an inventory of all federally owned 
property (as distinct from property acquired with grant funds) for which 
it is accountable and request disposition instructions from the Federal 
agency of property no longer needed.
    (c) Cost adjustment. The Federal agency will, within 90 days after 
receipt of reports in paragraph (b) of this section, make upward or 
downward adjustments to the allowable costs.
    (d) Cash adjustments. (1) The Federal agency will make prompt 
payment to the grantee for allowable reimbursable costs.
    (2) The grantee must immediately refund to the Federal agency any 
balance of unobligated (unencumbered) cash advanced that is not 
authorized to be retained for use on other grants.



Sec. 1403.51  Later disallowances and adjustments.

    The closeout of a grant does not affect:
    (a) The Federal agency's right to disallow costs and recover funds 
on the basis of a later audit or other review;
    (b) The grantee's obligation to return any funds due as a result of 
later refunds, corrections, or other transactions;
    (c) Records retention as required in Sec. 1403.42;
    (d) Property management requirements in Sec. 1403.31 and Sec. 
1403.32; and
    (e) Audit requirements in Sec. 1403.26.



Sec. 1403.52  Collection of amounts due.

    (a) Any funds paid to a grantee in excess of the amount to which the 
grantee is finally determined to be entitled under the terms of the 
award constitute a debt to the Federal Government. If not paid within a 
reasonable period after demand, the Federal agency may reduce the debt 
by:
    (1) Making an administrative offset against other requests for 
reimbursement,
    (2) Withholding advance payments otherwise due to the grantee, or
    (3) Other action permitted by law.
    (b) Except where otherwise provided by statutes or regulations, the 
Federal agency will charge interest on an overdue debt in accordance 
with the Federal Claims Collection Standards (4 CFR ch. II). The date 
from which interest is computed is not extended by litigation or the 
filing of any form of appeal.

Subpart E--Entitlement [Reserved]



Sec. Appendix A to Part 1403--OMB Circular A-128, ``Audits of State and 
                           Local Governments''

Circular No. A-128
April 12, 1985.

[[Page 279]]

To the Heads of Executive Departments and Establishments
Subject: Audits of State and Local Governments.
    1. Purpose. This Circular is issued pursuant to the Single Audit Act 
of 1984, Pub. L. 98-502. It establishes audit requirements for State and 
local governments that receive Federal aid, and defines Federal 
responsibilities for implementing and monitoring those requirements.
    2. Supersession. The Circular supersedes Attachment P, ``Audit 
Requirements,'' of Circular A-102, ``Uniform requirements for grants to 
State and local governments.''
    3. Background. The Single Audit Act builds upon earlier efforts to 
improve audits of Federal aid programs. The Act requires State or local 
governments that receive $100,000 or more a year in Federal funds to 
have an audit made for that year. Section 7505 of the Act requires the 
Director of the Office of Management and Budget to prescribe policies, 
procedures and guidelines to implement the Act. It specifies that the 
Director shall designate ``cognizant'' Federal agencies, determine 
criteria for making appropriate charges to federal programs for the cost 
of audits, and provide procedures to assure that small firms or firms 
owned and controlled by disadvantaged individuals have the opportunity 
to participate in contracts for single audits.
    4. Policy. The Single Audit Act requires the following:
    a. State or local governments that receive $100,000 or more a year 
in Federal financial assistance shall have an audit made in accordance 
with this Circular.
    b. State or local governments that receive between $25,000 and 
$100,000 a year shall have an audit made in accordance with this 
Circular, or in accordance with Federal laws and regulations governing 
the programs they participate in.
    c. State or local governments that receive less than $25,000 a year 
shall be exempt from compliance with the Act and other Federal audit 
requirements. These State and local governments shall be governed by 
audit requirements prescribed by State or local law or regulation.
    d. Nothing in this paragraph exempts State or local governments from 
maintaining records of Federal financial assistance or from providing 
access to such records to Federal agencies, as provided for in Federal 
law or in Circular A-102, ``Uniform requirements for grants to state or 
local governments.''
    5. Definitions. For the purposes of this Circular the following 
definitions from the Single Audit Act apply:
    a. Cognizant agency means the Federal agency assigned by the Office 
of Management and Budget to carry out the responsibilities described in 
paragraph 11 of this Circular.
    b. Federal financial assistance means assistance provided by a 
Federal agency in the form of grants, contracts, cooperative agreements, 
loans, loan guarantees, property, interest subsidies, insurance, or 
direct appropriations, but does not include direct Federal cash 
assistance to individuals. It includes awards received directly from 
Federal agencies, or indirectly through other units of States and local 
governments.
    c. Federal agency has the same meaning as the term ``agency'' in 
section 551(1) of Title 5, United States Code.
    d. Generally accepted accounting principles has the meaning 
specified in the generally accepted government auditing standards.
    e. Generally accepted government auditing standards means the 
Standards For Audit of Government Organizations, Programs, Activities, 
and Functions, developed by the Comptroller General, dated February 27, 
1981.
    f. Independent auditor means:
    (1) A State or local government auditor who meets the independence 
standards specified in generally accepted government auditing standards; 
or
    (2) A public accountant who meets such independence standards.
    g. Internal controls means the plan of organization and methods and 
procedures adopted by management to ensure that:
    (1) Resource use is consistent with laws, regulations, and policies;
    (2) Resources are safeguarded against waste, loss, and misuse; and
    (3) Reliable data are obtained, maintained, and fairly disclosed in 
reports.
    h. Indian tribe means any Indian tribe, band, nations, or other 
organized group or community, including any Alaskan Native village or 
regional or village corporations (as defined in, or established under, 
the Alaskan Native Claims Settlement Act) that is recognized by the 
United States as eligible for the special programs and services provided 
by the United States to Indians because of their status as Indians.
    i. Local government means any unit of local government within a 
State, including a county, a borough, municipality, city, town, 
township, parish, local public authority, special district, school 
district, intrastate district, council of government, and any other 
instrumentality of local government.
    j. Major Federal Assistance Program, as defined by Pub. L. 98-502, 
is described in the Attachment to this Circular.
    k. Public accountants means those individuals who meet the 
qualification standards included in generally accepted government 
auditing standards for personnel performing government audits.

[[Page 280]]

    l. State means any State of the United States, the District of 
Columbia, the Commonwealth of Puerto Rico, the Virgin Islands, Guam, 
American Samoa, the Commonwealth of the Northern Mariana Islands, and 
the Trust Territory of the Pacific Islands, any instrumentality thereof, 
and any multi-State, regional, or interstate entity that has 
governmental functions and any Indian tribe.
    m. Subrecipient means any person or government department, agency, 
or establishment that receives Federal financial assistance to carry out 
a program through a State or local government, but does not include an 
individual that is a beneficiary of such a program. A subrecipient may 
also be a direct recipient of Federal financial assistance.
    6. Scope of audit. The Single Act provides that:
    a. The audit shall be made by an independent auditor in accordance 
with generally accepted government auditing standards covering financial 
and compliance audits.
    b. The audit shall cover the entire operations of a State or local 
government or, at the option of that government, it may cover 
departments, agencies or establishments that received, expended, or 
otherwise administered Federal financial assistance during the year. 
However, if a State or local government receives $25,000 or more in 
General Revenue Sharing Funds in a fiscal year, it shall have an audit 
of its entire operations. A series of audits of individual departments, 
agencies, and establishments for the same fiscal year may be considered 
a single audit.
    c. Public hospitals and public colleges and universities may be 
excluded from State and local audits and the requirements of this 
Circular. However, if such entities are excluded, audits of these 
entities shall be made in accordance with statutory requirements and the 
provisions of Circular A-110, ``Uniform requirements for grants to 
universities, hospitals, and other nonprofit organizations.''
    d. The auditor shall determine whether:
    (1) The financial statements of the government, department, agency 
or establishment present fairly its financial position and the results 
of its financial operations in accordance with generally accepted 
accounting principles;
    (2) The organization has internal accounting and other control 
systems to provide reasonable assurance that it is managing Federal 
financial assistance programs in compliance with applicable laws and 
regulations; and
    (3) The organization has complied with laws and regulations that may 
have material effect on its financial statements and on each major 
Federal assistance program.
    7. Frequency of audit. Audits shall be made annually unless the 
State or local government has, by January 1, 1987, a constitutional or 
statutory requirement for less frequent audits. For those governments, 
the cognizant agency shall permit biennial audits, covering both years, 
if the government so requests. It shall also honor requests for biennial 
audits by governments that have an administrative policy calling for 
audits less frequent than annual, but only for fiscal years beginning 
before January 1, 1987.
    8. Internal control and compliance reviews. The Single Audit Act 
requires that the independent auditor determine and report on whether 
the organization has internal control systems to provide reasonable 
assurance that it is managing Federal assistance programs in compliance 
with applicable laws and regulations.
    a. Internal control review. In order to provide this assurance the 
auditor must make a study and evaluation of internal control systems 
used in administering Federal assistance programs. The study and 
evaluation must be made whether or not the auditor intends to place 
reliance on such systems. As part of this review, the auditor shall:
    (1) Test whether these internal control systems are functioning in 
accordance with prescribed procedures.
    (2) Examine the recipient's system for monitoring subrecipients and 
obtaining and acting on subrecipient audit reports.
    b. Compliance review. The law also requires the auditor to determine 
whether the organization has complied with laws and regulations that may 
have a material effect on each major Federal assistance program.
    (1) In order to determine which major programs are to be tested for 
compliance, State and local governments shall identify in their accounts 
all Federal funds received and expended and the programs under which 
they were received. This shall include funds received directly from 
Federal agencies and through other State and local governments.
    (2) The review must include the selection and testing of a 
representative number of charges from each major Federal assistance 
program. The selection and testing of transactions shall be based on the 
auditor's professional judgment considering such factors as the amount 
of expenditures for the program and the individual awards; the newness 
of the program or changes in its conditions; prior experience with the 
program, particularly as revealed in audits and other evaluations (e.g., 
inspections program reviews); the extent to which the program is carried 
out through subrecipients; the extent to which the program contracts for 
goods or services; the level to which the program is already subject to 
program reviews or other forms of independent oversight; the adequacy of 
the controls for ensuring compliance; the exception of adherence or lack 
of adherence to the applicable laws and regulations; and the potential 
impact of adverse findings.

[[Page 281]]

    (a) In making the test of transactions, the auditor shall determine 
whether:
--The amounts reported as expenditures were for allowable services, and
--The records show that those who received services or benefits were 
eligible to receive them.
    (b) In addition to transaction testing, the auditor shall determine 
whether:
--Matching requirements, levels of effort and earmarking limitations 
were met,
--Federal financial reports and claims for advances and reimbursements 
contain information that is supported by the books and records from 
which the basic financial statements have been prepared, and
--Amounts claimed or used for matching were determined in accordance 
with OMB Circular A-87, ``Cost principles for State and local 
governments,'' and Attachment F of Circular A-102, ``Uniform 
requirements for grants to State and local governments.''
    (c) The principal compliance requirements of the largest Federal aid 
programs may be ascertained by referring to the Compliance Supplement 
for Single Audits of State and Local Governments, issued by OMB and 
available from the Government Printing Office. For those programs not 
covered in the Compliance Supplement, the auditor may ascertain 
compliance requirements by researching the statutes, regulations, and 
agreements governing individual programs.
    (3) Transactions related to other Federal assistance programs that 
are selected in connection with examinations of financial statements and 
evaluations of internal controls shall be tested for compliance with 
Federal laws and regulations that apply to such transactions.
    9. Subrecipients. State or local governments that receive Federal 
financial assistance and provide $25,000 or more of it in a fiscal year 
to a subrecipient shall:
    a. Determine whether State or local subrecipients have met the audit 
requirements of this Circular and whether subrecipients covered by 
Circular A-110, ``Uniform requirements for grants to universities, 
hospitals, and other nonprofit organizations,'' have met that 
requirement;
    b. Determine whether the subrecipient spent Federal assistance funds 
provided in accordance with applicable laws and regulations. This may be 
accomplished by reviewing an audit of the subrecipient made in 
accordance with this Circular, Circular A-110, or through other means 
(e.g., program reviews) if the subrecipient has not yet had such an 
audit;
    c. Ensure that appropriate corrective action is taken within six 
months after receipt of the audit report in instances of noncompliance 
with Federal laws and regulations;
    d. Consider whether subrecipient audits necessitate adjustment of 
the recipient's own records; and
    e. Require each subrecipient to permit independent auditors to have 
access to the records and financial statements as necessary to comply 
with this Circular.
    10. Relation to other audit requirements. The Single Audit Act 
provides that an audit made in accordance with this Circular shall be in 
lieu of any financial or financial compliance audit required under 
individual Federal assistance programs. To the extent that a single 
audit provides Federal agencies with information and assurances they 
need to carry out their overall responsibilities, they shall rely upon 
and use such information. However, a Federal agency shall make any 
additional audits which are necessary to carry out its responsibilities 
under Federal law and regulation. Any additional Federal audit effort 
shall be planned and carried out in such a way as to avoid duplication.
    a. The provisions of this Circular do not limit the authority of 
Federal agencies to make, or contract for audits and evaluations of 
Federal financial assistance programs, nor do they limit the authority 
of any Federal agency Inspector General or other Federal audit official.
    b. The provisions of this Circular do not authorize any State or 
local government or subrecipient thereof to constrain Federal agencies, 
in any manner, from carrying out additional audits.
    c. A Federal agency that makes or contracts for audits in addition 
to the audits made by recipients pursuant to this Circular shall, 
consistent with other applicable laws and regulations, arrange for 
funding the cost of such additional audits. Such additional audits 
include economy and efficiency audits, program results audits, and 
program evaluations.
    11. Cognizant agency responsibilities. The Single Audit Act provides 
for cognizant Federal agencies to oversee the implementation of this 
Circular.
    a. The Office of Management and Budget will assign cognizant 
agencies for States and their subdivisions and larger local governments 
and their subdivisions. Other Federal agencies may participate with an 
assigned cognizant agency, in order to fulfill the cognizance 
responsibilities. Smaller governments not assigned a cognizant agency 
will be under the general oversight of the Federal agency that provides 
them the most funds whether directly or indirectly.
    b. A cognizant agency shall have the following responsibilities:
    (1) Ensure that audits are made and reports are received in a timely 
manner and in accordance with the requirements of this Circular.

[[Page 282]]

    (2) Provide technical advice and liaison to State and local 
governments and independent auditors.
    (3) Obtain or make quality control reviews of selected audits made 
by non-Federal audit organizations, and provide the results, when 
appropriate, to other interested organizations.
    (4) Promptly inform other affected Federal agencies and appropriate 
Federal law enforcement officials of any reported illegal acts or 
irregularities. They should also inform State or local law enforcement 
and prosecuting authorities, if not advised by the recipient, of any 
violation of law within their jurisdiction.
    (5) Advise the recipient of audits that have been found not to have 
met the requirements set forth in this Circular. In such instances, the 
recipient will be expected to work with the auditor to take corrective 
action. If corrective action is not taken, the cognizant agency shall 
notify the recipient and Federal awarding agencies of the facts and make 
recommendations for followup action. Major inadequacies or repetitive 
substandard performance of independent auditors shall be referred to 
appropriate professional bodies for disciplinary action.
    (6) Coordinate, to the extent practicable, audits made by or for 
Federal agencies that are in addition to the audits made pursuant to 
this Circular; so that the additional audits build upon such audits.
    (7) Oversee the resolution of audit findings that affect the 
programs of more than one agency.
    12. Illegal acts or irregularities. If the auditor becomes aware of 
illegal acts or other irregularities, prompt notice shall be given to 
recipient management officials above the level of involvement. (See also 
paragraph 13(a)(3) below for the auditor's reporting responsibilities.) 
The recipient, in turn, shall promptly notify the cognizant agency of 
the illegal acts or irregularities and of proposed and actual actions, 
if any. Illegal acts and irregularities include such matters as 
conflicts of interest, falsification of records or reports, and 
misappropriations of funds or other assets.
    13. Audit reports. Audit reports must be prepared at the completion 
of the audit. Reports serve many needs of State and local governments as 
well as meeting the requirements of the Single Audit Act.
    a. The audit report shall state that the audit was made in 
accordance with the provisions of this Circular. The report shall be 
made up of at least:
    (1) The auditor's report on financial statements and on a schedule 
of Federal assistance; the financial statements; and a schedule of 
Federal assistance, showing the total expenditures for each Federal 
assistance program as identified in the Catalog of Federal Domestic 
Assistance. Federal programs or grants that have not been assigned a 
catalog number shall be identified under the caption ``other Federal 
assistance.''
    (2) The auditor's report on the study and evaluation of internal 
control systems must identify the organization's significant internal 
accounting controls, and those controls designed to provide reasonable 
assurance that Federal programs are being managed in compliance with 
laws and regulations. It must also identify the controls that were 
evaluated, the controls that were not evaluated, and the material 
weaknesses identified as a result of the evaluation.
    (3) The auditor's report on compliance containing:
--A statement of positive assurance with respect to those items tested 
for compliance, including compliance with law and regulations pertaining 
to financial reports and claims for advances and reimbursements;
--Negative assurance on those items not tested;
--A summary of all instances of noncompliance; and
--An identification of total amounts questioned, if any, for each 
Federal assistance award, as a result of noncompliance.
    b. The three parts of the audit report may be bound into a single 
report, or presented at the same time as separate documents.
    c. All fraud abuse, or illegal acts or indications of such acts, 
including all questioned costs found as the result of these acts that 
auditors become aware of, should normally be covered in a separate 
written report submitted in accordance with paragraph 13f.
    d. In addition to the audit report, the recipient shall provide 
comments on the findings and recommendations in the report, including a 
plan for corrective action taken or planned and comments on the status 
of corrective action taken on prior findings. If corrective action is 
not necessary, a statement describing the reason it is not should 
accompany the audit report.
    e. The reports shall be made available by the State or local 
government for public inspection within 30 days after the completion of 
the audit.
    f. In accordance with generally accepted government audit standards, 
reports shall be submitted by the auditor to the organization audited 
and to those requiring or arranging for the audit. In addition, the 
recipient shall submit copies of the reports to each Federal department 
or agency that provided Federal assistance funds to the recipient. 
Subrecipients shall submit copies to recipients that provided them 
Federal assistance funds. The reports shall be sent within 30 days after 
the completion of the audit, but no later than one year after the end of 
the audit period unless a longer period is agreed to with the cognizant 
agency.
    g. Recipients of more than $100,000 in Federal funds shall submit 
one copy of the audit

[[Page 283]]

report within 30 days after issuance to a central clearinghouse to be 
designated by the Office of Management and Budget. The clearinghouse 
will keep completed audits on file and follow up with State and local 
governments that have not submitted required audit reports.
    h. Recipients shall keep audit reports on file for three years from 
their issuance.
    14. Audit Resolution. As provided in paragraph 11, the cognizant 
agency shall be responsible for monitoring the resolution of audit 
findings that affect the programs of more than one Federal agency. 
Resolution of findings that relate to the programs of a single Federal 
agency will be the responsibility of the recipient and that agency. 
Alternate arrangements may be made on a case-by-case basis by agreement 
among the agencies concerned.
    Resolution shall be made within six months after receipt of the 
report by the Federal departments and agencies. Corrective action should 
proceed as rapidly as possible.
    15. Audit workpapers and reports. Workpapers and reports shall be 
retained for a minimum of three years from the date of the audit report, 
unless the auditor is notified in writing by the cognizant agency to 
extend the retention period. Audit workpapers shall be made available 
upon request to the cognizant agency or its designee or the General 
Accounting Office, at the completion of the audit.
    16. Audit Costs. The cost of audits made in accordance with the 
provisions of this Circular are allowable charges to Federal assistance 
programs.
    a. The charges may be considered a direct cost or an allocated 
indirect cost, determined in accordance with the provision of Circular 
A-87, ``Cost principles for State and local governments.''
    b. Generally, the percentage of costs charged to Federal assistance 
programs for a single audit shall not exceed the percentage that Federal 
funds expended represent of total funds expended by the recipient during 
the fiscal year. The percentage may be exceeded, however, if appropriate 
documentation demonstrates higher actual cost.
    17. Sanctions. The Single Audit Act provides that no cost may be 
charged to Federal assistance programs for audits required by the Act 
that are not made in accordance with this Circular. In cases of 
continued inability or unwillingness to have a proper audit, Federal 
agencies must consider other appropriate sanctions including:
--Withhodling a percentage of assistance payments until the audit is 
completed satisfactorily,
--Withholding or disallowing overhead costs, and
--Suspending the Federal assistance agreement until the audit is made.
    18. Auditor Selection. In arranging for audit services State and 
local governments shall follow the procurement standards prescribed by 
Attachment O of Circular A-102, ``Uniform requirements for grants to 
State and local governments.'' The standards provide that while 
recipients are encouraged to enter into intergovernmental agreements for 
audit and other services, analysis should be made to determine whether 
it would be more economical to purchase the services from private firms. 
In instances where use of such intergovernmental agreements are required 
by State statutes (e.g., audit services) these statutes will take 
precedence.
    19. Small and Minority Audit Firms. Small audit firms and audit 
firms owned and controlled by socially and economically disadvantaged 
individuals shall have the maximum practicable opportunity to 
participate in contracts awarded to fulfill the requirements of this 
Circular. Recipients of Federal assistance shall take the following 
steps to further this goal:
    a. Assure that small audit firms and audit firms owned and 
controlled by socially and economically disadvantaged individuals are 
used to the fullest extent practicable.
    b. Make information on forthcoming opportunities available and 
arrange time frames for the audit so as to encourage and facilitate 
participation by small audit firms and audit firms owned and controlled 
by socially and economically disadvantaged individuals.
    c. Consider in the contract process whether firms competing for 
larger audits intend to subcontract with small audit firms and audit 
firms owned and controlled by socially and economically disadvantaged 
individuals.
    d. Encourage contracting with small audit firms or audit firms owned 
and controlled by socially and economically disadvantaged individuals 
which have traditionally audited government programs and, in such cases 
where this is not possible, assure that these firms are given 
consideration for audit subcontracting opportunities.
    e. Encourage contracting with consortiums of small audit firms as 
described in paragraph (a) above when a contract is too large for an 
individual small audit firm or audit firm owned and controlled by 
socially and economically disadvantaged individuals.
    f. Use the services and assistance, as appropriate, of such 
organizations as the Small Business Administration in the solicitation 
and utilization of small audit firms or audit firms owned and controlled 
by socially and economically disadvantaged individuals.
    20. Reporting. Each Federal agency will report to the Director of 
OMB on or before March 1, 1987, and annually thereafter on the 
effectiveness of State and local governments in carrying out the 
provisions of this Circular. The report must identify each State or 
local government or Indian tribe that, in the

[[Page 284]]

opinion of the agency, is failing to comply with Circular.
    21. Regulations. Each Federal agency shall include the provisions of 
this Circular in its regulations implementing the Single Audit Act.
    22. Effective date. This Circular is effective upon publication and 
shall apply to fiscal years of State and local governments that begin 
after December 31, 1984. Earlier implementation is encouraged. However, 
until it is implemented, the audit provisions of Attachment P to 
Circular A-102 shall continue to be observed.
    23. Inquiries. All questions or inquiries should be addressed to 
Financial Management Division, Office of Management and Budget, 
telephone number (202) 395-3993.
    24. Sunset review date. This Circular shall have an independent 
policy review to ascertain its effectiveness three years from the date 
of issuance.

David A. Stockman,
    Director.

                        Circular A-128 Attachment

        Definition of Major Program as Provided in Pub. L. 98-502

    ``Major Federal Assistance Program,'' for State and local 
governments having Federal assistance expenditures between $100,000 and 
$100,000,000. means any program for which Federal expenditures during 
the applicable year exceed the larger of $300,000, or 3 percent of such 
total expenditures.
    Where total expenditures of Federal assistance exceed $100,000,000, 
the following criteria apply:

------------------------------------------------------------------------
     Total expenditures of Federal financial           Major Federal
           assistance for all programs              assistance program
------------------------------------------------- means any program that
       More than              But less than               exceeds
------------------------------------------------------------------------
$100 million             1 billion                $3 million
    1 billion            2 billion                4 million
    2 billion            3 billion                7 million
    3 billion            4 billion                10 million
    4 billion            5 billion                13 million
    5 billion            6 billion                16 million
    6 billion            7 billion                19 million
Over 7 billion           .......................  20 million
------------------------------------------------------------------------


[57 FR 55092, Nov. 24, 1992; 58 FR 26185, Apr. 30, 1993]



PART 1404_GOVERNMENTWIDE DEBARMENT AND SUSPENSION 
(NONPROCUREMENT)--Table of Contents



Sec.
1404.25 How is this part organized?
1404.50 How is this part written?
1404.75 Do terms in this part have special meanings?

                            Subpart A_General

1404.100 What does this part do?
1404.105 Does this part apply to me?
1404.110 What is the purpose of the nonprocurement debarment and 
          suspension system?
1404.115 How does an exclusion restrict a person's involvement in 
          covered transactions?
1404.120 May we grant an exception to let an excluded person participate 
          in a covered transaction?
1404.125 Does an exclusion under the nonprocurement system affect a 
          person's eligibility for Federal procurement contracts?
1404.130 Does exclusion under the Federal procurement system affect a 
          person's eligibility to participate in nonprocurement 
          transactions?
1404.135 May the Office of National Drug Control Policy exclude a person 
          who is not currently participating in a nonprocurement 
          transaction?
1404.140 How do I know if a person is excluded?
1404.145 Does this part address persons who are disqualified, as well as 
          those who are excluded from nonprocurement transactions?

                     Subpart B_Covered Transactions

1404.200 What is a covered transaction?
1404.205 Why is it important to know if a particular transaction is a 
          covered transaction?
1404.210 Which nonprocurement transactions are covered transactions?
1404.215 Which nonprocurement transactions are not covered transactions?
1404.220 Are any procurement contracts included as covered transactions?
1404.225 How do I know if a transaction in which I may participate is a 
          covered transaction?

    Subpart C_Responsibilities of Participants Regarding Transactions

                    Doing Business With Other Persons

1404.300 What must I do before I enter into a covered transaction with 
          another person at the next lower tier?
1404.305 May I enter into a covered transaction with an excluded or 
          disqualified person?
1404.310 What must I do if a Federal agency excludes a person with whom 
          I am already doing business in a covered transaction?
1404.315 May I use the services of an excluded person as a principal 
          under a covered transaction?

[[Page 285]]

1404.320 Must I verify that principals of my covered transactions are 
          eligible to participate?
1404.325 What happens if I do business with an excluded person in a 
          covered transaction?
1404.330 What requirements must I pass down to persons at lower tiers 
          with whom I intend to do business?

            Disclosing Information--Primary Tier Participants

1404.335 What information must I provide before entering into a covered 
          transaction with the Office of National Drug Control Policy?
1404.340 If I disclose unfavorable information required under Sec. 
          1404.335, will I be prevented from participating in the 
          transaction?
1404.345 What happens if I fail to disclose the information required 
          under Sec. 1404.335?
1404.350 What must I do if I learn of the information required under 
          Sec. 1404.335 after entering into a covered transaction with 
          the Office of National Drug Control Policy?

             Disclosing Information--Lower Tier Participants

1404.355 What information must I provide to a higher tier participant 
          before entering into a covered transaction with that 
          participant?
1404.360 What happens if I fail to disclose the information required 
          under Sec. 1404.355?
1404.365 What must I do if I learn of information required under Sec. 
          1404.355 after entering into a covered transaction with a 
          higher tier participant?

  Subpart D_Responsibilities of Office of National Drug Control Policy 
                    Officials Regarding Transactions

1404.400 May I enter into a transaction with an excluded or disqualified 
          person?
1404.405 May I enter into a covered transaction with a participant if a 
          principal of the transaction is excluded?
1404.410 May I approve a participant's use of the services of an 
          excluded person?
1404.415 What must I do if a Federal agency excludes the participant or 
          a principal after I enter into a covered transaction?
1404.420 May I approve a transaction with an excluded or disqualified 
          person at a lower tier?
1404.425 When do I check to see if a person is excluded or disqualified?
1404.430 How do I check to see if a person is excluded or disqualified?
1404.435 What must I require of a primary tier participant?
1404.440 What method do I use to communicate those requirements to 
          participants?
1404.445 What action may I take if a primary tier participant knowingly 
          does business with an excluded or disqualified person?
1404.450 What action may I take if a primary tier participant fails to 
          disclose the information required under Sec. 1404.335?
1404.455 What may I do if a lower tier participant fails to disclose the 
          information required under Sec. 1404.355 to the next higher 
          tier?

                 Subpart E_Excluded Parties List System

1404.500 What is the purpose of the Excluded Parties List System (EPLS)?
1404.505 Who uses the EPLS?
1404.510 Who maintains the EPLS?
1404.515 What specific information is in the EPLS?
1404.520 Who places the information into the EPLS?
1404.525 Whom do I ask if I have questions about a person in the EPLS?
1404.530 Where can I find the EPLS?

   Subpart F_General Principles Relating to Suspension and Debarment 
                                 Actions

1404.600 How do suspension and debarment actions start?
1404.605 How does suspension differ from debarment?
1404.610 What procedures does the Office of National Drug Control Policy 
          use in suspension and debarment actions?
1404.615 How does the Office of National Drug Control Policy notify a 
          person of a suspension and debarment action?
1404.620 Do Federal agencies coordinate suspension and debarment 
          actions?
1404.625 What is the scope of a suspension or debarment action?
1404.630 May the Office of National Drug Control Policy impute the 
          conduct of one person to another?
1404.635 May the Office of National Drug Control Policy settle a 
          debarment or suspension action?
1404.640 May a settlement include a voluntary exclusion?
1404.645 Do other Federal agencies know if the Office of National Drug 
          Control Policy agrees to a voluntary exclusion?

                          Subpart G_Suspension

1404.700 When may the suspending official issue a suspension?
1404.705 What does the suspending official consider in issuing a 
          suspension?
1404.710 When does a suspension take effect?
1404.715 What notice does the suspending official give me if I am 
          suspended?

[[Page 286]]

1404.720 How may I contest a suspension?
1404.725 How much time do I have to contest a suspension?
1404.730 What information must I provide to the suspending official if I 
          contest a suspension?
1404.735 Under what conditions do I get an additional opportunity to 
          challenge the facts on which the suspension is based?
1404.740 Are suspension proceedings formal?
1404.745 How is fact-finding conducted?
1404.750 What does the suspending official consider in deciding whether 
          to continue or terminate my suspension?
1404.755 When will I know whether the suspension is continued or 
          terminated?
1404.760 How long may my suspension last?

                           Subpart H_Debarment

1404.800 What are the causes for debarment?
1404.805 What notice does the debarring official give me if I am 
          proposed for debarment?
1404.810 When does a debarment take effect?
1404.815 How may I contest a proposed debarment?
1404.820 How much time do I have to contest a proposed debarment?
1404.825 What information must I provide to the debarring official if I 
          contest a proposed debarment?
1404.830 Under what conditions do I get an additional opportunity to 
          challenge the facts on which the proposed debarment is based?
1404.835 Are debarment proceedings formal?
1404.840 How is fact-finding conducted?
1404.845 What does the debarring official consider in deciding whether 
          to debar me?
1404.850 What is the standard of proof in a debarment action?
1404.855 Who has the burden of proof in a debarment action?
1404.860 What factors may influence the debarring official's decision?
1404.865 How long may my debarment last?
1404.870 When do I know if the debarring official debars me?
1404.875 May I ask the debarring official to reconsider a decision to 
          debar me?
1404.880 What factors may influence the debarring official during 
          reconsideration?
1404.885 May the debarring official extend a debarment?

                          Subpart I_Definitions

1404.900 Adequate evidence.
1404.905 Affiliate.
1404.910 Agency.
1404.915 Agent or representative.
1404.920 Civil judgment.
1404.925 Conviction.
1404.930 Debarment.
1404.935 Debarring official.
1404.940 Disqualified.
1404.945 Excluded or exclusion.
1404.950 Excluded Parties List System.
1404.955 Indictment.
1404.960 Ineligible or ineligibility.
1404.965 Legal proceedings.
1404.970 Nonprocurement transaction.
1404.975 Notice.
1404.980 Participant.
1404.985 Person.
1404.990 Preponderance of the evidence.
1404.995 Principal.
1404.1000 Respondent.
1404.1005 State.
1404.1010 Suspending official.
1404.1015 Suspension.
1404.1020 Voluntary exclusion or voluntarily excluded.

Subpart J [Reserved]

Appendix to Part 1404--Covered Transactions

    Authority: E.O. 12549 3 CFR 1986 Comp., p. 189; E.O. 12689 3 CFR 
1989 Comp., p. 235; sec. 2455, Pub. L. 103-355, 108 Stat. 3327 (31 
U.S.C. 6101 note); 21 U.S.C. 1701.

    Source: 68 FR 66544, 66580, 66581, Nov. 26, 2003, unless otherwise 
noted.



Sec. 1404.25  How is this part organized?

    (a) This part is subdivided into ten subparts. Each subpart contains 
information related to a broad topic or specific audience with special 
responsibilities, as shown in the following table:

------------------------------------------------------------------------
       In subpart . . .        You will find provisions related to . . .
------------------------------------------------------------------------
A............................  general information about this rule.
B............................  the types of Office of National Drug
                                Control Policy transactions that are
                                covered by the Governmentwide
                                nonprocurement suspension and debarment
                                system.
C............................  the responsibilities of persons who
                                participate in covered transactions.
D............................  the responsibilities of Office of
                                National Drug Control Policy officials
                                who are authorized to enter into covered
                                transactions.
E............................  the responsibilities of Federal agencies
                                for the Excluded Parties List System
                                (Disseminated by the General Services
                                Administration).
F............................  the general principles governing
                                suspension, debarment, voluntary
                                exclusion and settlement.
G............................  suspension actions.
H............................  debarment actions.
I............................  definitions of terms used in this part.

[[Page 287]]

 
J............................  [Reserved]
------------------------------------------------------------------------

    (b) The following table shows which subparts may be of special 
interest to you, depending on who you are:

------------------------------------------------------------------------
             If you are . . .                   See subpart(s) . . .
------------------------------------------------------------------------
(1) a participant or principal in a         A, B, C, and I.
 nonprocurement transaction.
(2) a respondent in a suspension action...  A, B, F, G and I.
(3) a respondent in a debarment action....  A, B, F, H and I.
(4) a suspending official.................  A, B, D, E, F, G and I.
(5) a debarring official..................  A, B, D, E, F, H and I.
(6) a (n) Office of National Drug Control   A, B, D, E and I.
 Policy official authorized to enter into
 a covered transaction.
(7) Reserved..............................  J.
------------------------------------------------------------------------



Sec. 1404.50  How is this part written?

    (a) This part uses a ``plain language'' format to make it easier for 
the general public and business community to use. The section headings 
and text, often in the form of questions and answers, must be read 
together.
    (b) Pronouns used within this part, such as ``I'' and ``you,'' 
change from subpart to subpart depending on the audience being 
addressed. The pronoun ``we'' always is the Office of National Drug 
Control Policy.
    (c) The ``Covered Transactions'' diagram in the appendix to this 
part shows the levels or ``tiers'' at which the Office of National Drug 
Control Policy enforces an exclusion under this part.



Sec. 1404.75  Do terms in this part have special meanings?

    This part uses terms throughout the text that have special meaning. 
Those terms are defined in Subpart I of this part. For example, three 
important terms are--
    (a) Exclusion or excluded, which refers only to discretionary 
actions taken by a suspending or debarring official under this part or 
the Federal Acquisition Regulation (48 CFR part 9, subpart 9.4);
    (b) Disqualification or disqualified, which refers to prohibitions 
under specific statutes, executive orders (other than Executive Order 
12549 and Executive Order 12689), or other authorities. 
Disqualifications frequently are not subject to the discretion of an 
agency official, may have a different scope than exclusions, or have 
special conditions that apply to the disqualification; and
    (c) Ineligibility or ineligible, which generally refers to a person 
who is either excluded or disqualified.



                            Subpart A_General



Sec. 1404.100  What does this part do?

    This part adopts a governmentwide system of debarment and suspension 
for Office of National Drug Control Policy nonprocurement activities. It 
also provides for reciprocal exclusion of persons who have been excluded 
under the Federal Acquisition Regulation, and provides for the 
consolidated listing of all persons who are excluded, or disqualified by 
statute, executive order, or other legal authority. This part satisfies 
the requirements in section 3 of Executive Order 12549, ``Debarment and 
Suspension'' (3 CFR 1986 Comp., p. 189), Executive Order 12689, 
``Debarment and Suspension'' (3 CFR 1989 Comp., p. 235) and 31 U.S.C. 
6101 note (Section 2455, Public Law 103-355, 108 Stat. 3327).



Sec. 1404.105  Does this part apply to me?

    Portions of this part (see table at Sec. 1404.25(b)) apply to you 
if you are a(n)--
    (a) Person who has been, is, or may reasonably be expected to be, a 
participant or principal in a covered transaction;
    (b) Respondent (a person against whom the Office of National Drug 
Control Policy has initiated a debarment or suspension action);
    (c) Office of National Drug Control Policy debarring or suspending 
official; or
    (d) Office of National Drug Control Policy official who is 
authorized to enter into covered transactions with non-Federal parties.

[[Page 288]]



Sec. 1404.110  What is the purpose of the nonprocurement debarment 
and suspension system?

    (a) To protect the public interest, the Federal Government ensures 
the integrity of Federal programs by conducting business only with 
responsible persons.
    (b) A Federal agency uses the nonprocurement debarment and 
suspension system to exclude from Federal programs persons who are not 
presently responsible.
    (c) An exclusion is a serious action that a Federal agency may take 
only to protect the public interest. A Federal agency may not exclude a 
person or commodity for the purposes of punishment.



Sec. 1404.115  How does an exclusion restrict a person's involvement
in covered transactions?

    With the exceptions stated in Sec. Sec. 1404.120, 1404.315, and 
1404.420, a person who is excluded by the Office of National Drug 
Control Policy or any other Federal agency may not:
    (a) Be a participant in a(n) Office of National Drug Control Policy 
transaction that is a covered transaction under subpart B of this part;
    (b) Be a participant in a transaction of any other Federal agency 
that is a covered transaction under that agency's regulation for 
debarment and suspension; or
    (c) Act as a principal of a person participating in one of those 
covered transactions.



Sec. 1404.120  May we grant an exception to let an excluded person
participate in a covered transaction?

    (a) The Director of National Drug Control Policy may grant an 
exception permitting an excluded person to participate in a particular 
covered transaction. If the Director of National Drug Control Policy 
grants an exception, the exception must be in writing and state the 
reason(s) for deviating from the governmentwide policy in Executive 
Order 12549.
    (b) An exception granted by one agency for an excluded person does 
not extend to the covered transactions of another agency.



Sec. 1404.125  Does an exclusion under the nonprocurement system
affect a person's eligibility for Federal procurement contracts?

    If any Federal agency excludes a person under its nonprocurement 
common rule on or after August 25, 1995, the excluded person is also 
ineligible to participate in Federal procurement transactions under the 
FAR. Therefore, an exclusion under this part has reciprocal effect in 
Federal procurement transactions.



Sec. 1404.130  Does exclusion under the Federal procurement system 
affect a person's eligibility to participate in nonprocurement

transactions?

    If any Federal agency excludes a person under the FAR on or after 
August 25, 1995, the excluded person is also ineligible to participate 
in nonprocurement covered transactions under this part. Therefore, an 
exclusion under the FAR has reciprocal effect in Federal nonprocurement 
transactions.



Sec. 1404.135  May the Office of National Drug Control Policy exclude
a person who is not currently participating in a nonprocurement

transaction?

    Given a cause that justifies an exclusion under this part, we may 
exclude any person who has been involved, is currently involved, or may 
reasonably be expected to be involved in a covered transaction.



Sec. 1404.140  How do I know if a person is excluded?

    Check the Excluded Parties List System (EPLS) to determine whether a 
person is excluded. The General Services Administration (GSA) maintains 
the EPLS and makes it available, as detailed in subpart E of this part. 
When a Federal agency takes an action to exclude a person under the 
nonprocurement or procurement debarment and suspension system, the 
agency enters the information about the excluded person into the EPLS.



Sec. 1404.145  Does this part address persons who are disqualified,
as well as those who are excluded from nonprocurement transactions?

    Except if provided for in Subpart J of this part, this part--

[[Page 289]]

    (a) Addresses disqualified persons only to--
    (1) Provide for their inclusion in the EPLS; and
    (2) State responsibilities of Federal agencies and participants to 
check for disqualified persons before entering into covered 
transactions.
    (b) Does not specify the--
    (1) Office of National Drug Control Policy transactions for which a 
disqualified person is ineligible. Those transactions vary on a case-by-
case basis, because they depend on the language of the specific statute, 
Executive order, or regulation that caused the disqualification;
    (2) Entities to which the disqualification applies; or
    (3) Process that the agency uses to disqualify a person. Unlike 
exclusion, disqualification is frequently not a discretionary action 
that a Federal agency takes.



                     Subpart B_Covered Transactions



Sec. 1404.200  What is a covered transaction?

    A covered transaction is a nonprocurement or procurement transaction 
that is subject to the prohibitions of this part. It may be a 
transaction at--
    (a) The primary tier, between a Federal agency and a person (see 
appendix to this part); or
    (b) A lower tier, between a participant in a covered transaction and 
another person.



Sec. 1404.205  Why is it important if a particular transaction is a 
covered transaction?

    The importance of a covered transaction depends upon who you are.
    (a) As a participant in the transaction, you have the 
responsibilities laid out in Subpart C of this part. Those include 
responsibilities to the person or Federal agency at the next higher tier 
from whom you received the transaction, if any. They also include 
responsibilities if you subsequently enter into other covered 
transactions with persons at the next lower tier.
    (b) As a Federal official who enters into a primary tier 
transaction, you have the responsibilities laid out in subpart D of this 
part.
    (c) As an excluded person, you may not be a participant or principal 
in the transaction unless--
    (1) The person who entered into the transaction with you allows you 
to continue your involvement in a transaction that predates your 
exclusion, as permitted under Sec. 1404.310 or Sec. 1404.415; or
    (2) A(n) Office of National Drug Control Policy official obtains an 
exception from the Director of National Drug Control Policy to allow you 
to be involved in the transaction, as permitted under Sec. 1404.120.



Sec. 1404.210  Which nonprocurement transactions are covered 
transactions?

    All nonprocurement transactions, as defined in Sec. 1404.970, are 
covered transactions unless listed in Sec. 1404.215. (See appendix to 
this part.)



Sec. 1404.215  Which nonprocurement transactions are not covered 
transactions?

    The following types of nonprocurement transactions are not covered 
transactions:
    (a) A direct award to--
    (1) A foreign government or foreign governmental entity;
    (2) A public international organization;
    (3) An entity owned (in whole or in part) or controlled by a foreign 
government; or
    (4) Any other entity consisting wholly or partially of one or more 
foreign governments or foreign governmental entities.
    (b) A benefit to an individual as a personal entitlement without 
regard to the individual's present responsibility (but benefits received 
in an individual's business capacity are not excepted). For example, if 
a person receives social security benefits under the Supplemental 
Security Income provisions of the Social Security Act, 42 U.S.C. 1301 et 
seq., those benefits are not covered transactions and, therefore, are 
not affected if the person is excluded.
    (c) Federal employment.
    (d) A transaction that the Office of National Drug Control Policy 
needs to

[[Page 290]]

respond to a national or agency-recognized emergency or disaster.
    (e) A permit, license, certificate, or similar instrument issued as 
a means to regulate public health, safety, or the environment, unless 
the Office of National Drug Control Policy specifically designates it to 
be a covered transaction.
    (f) An incidental benefit that results from ordinary governmental 
operations.
    (g) Any other transaction if the application of an exclusion to the 
transaction is prohibited by law.



Sec. 1404.220  Are any procurement contracts included as covered 
transactions?

    (a) Covered transactions under this part--
    (1) Do not include any procurement contracts awarded directly by a 
Federal agency; but
    (2) Do include some procurement contracts awarded by non-Federal 
participants in nonprocurement covered transactions (see appendix to 
this part).
    (b) Specifically, a contract for goods or services is a covered 
transaction if any of the following applies:
    (1) The contract is awarded by a participant in a nonprocurement 
transaction that is covered under Sec. 1404.210, and the amount of the 
contract is expected to equal or exceed $25,000.
    (2) The contract requires the consent of a(n) Office of National 
Drug Control Policy official. In that case, the contract, regardless of 
the amount, always is a covered transaction, and it does not matter who 
awarded it. For example, it could be a subcontract awarded by a 
contractor at a tier below a nonprocurement transaction, as shown in the 
appendix to this part.
    (3) The contract is for federally-required audit services.



Sec. 1404.225  How do I know if a transaction in which I may 
participate is a covered transaction?

    As a participant in a transaction, you will know that it is a 
covered transaction because the agency regulations governing the 
transaction, the appropriate agency official, or participant at the next 
higher tier who enters into the transaction with you, will tell you that 
you must comply with applicable portions of this part.



    Subpart C_Responsibilities of Participants Regarding Transactions

                    Doing Business With Other Persons



Sec. 1404.300  What must I do before I enter into a covered transaction
with another person at the next lower tier?

    When you enter into a covered transaction with another person at the 
next lower tier, you must verify that the person with whom you intend to 
do business is not excluded or disqualified. You do this by:
    (a) Checking the EPLS; or
    (b) Collecting a certification from that person if allowed by this 
rule; or
    (c) Adding a clause or condition to the covered transaction with 
that person.



Sec. 1404.305  May I enter into a covered transaction with an excluded
or disqualified person?

    (a) You as a participant may not enter into a covered transaction 
with an excluded person, unless the Office of National Drug Control 
Policy grants an exception under Sec. 1404.120.
    (b) You may not enter into any transaction with a person who is 
disqualified from that transaction, unless you have obtained an 
exception under the disqualifying statute, Executive order, or 
regulation.



Sec. 1404.310  What must I do if a Federal agency excludes a person 
with whom I am already doing business in a covered transaction?

    (a) You as a participant may continue covered transactions with an 
excluded person if the transactions were in existence when the agency 
excluded the person. However, you are not required to continue the 
transactions, and you may consider termination. You should make a 
decision about whether to terminate and the type of termination action, 
if any, only after a thorough review to ensure that the action is proper 
and appropriate.
    (b) You may not renew or extend covered transactions (other than no-
cost time extensions) with any excluded

[[Page 291]]

person, unless the Office of National Drug Control Policy grants an 
exception under Sec. 1404.120.



Sec. 1404.315  May I use the services of an excluded person as a
principal under a covered transaction?

    (a) You as a participant may continue to use the services of an 
excluded person as a principal under a covered transaction if you were 
using the services of that person in the transaction before the person 
was excluded. However, you are not required to continue using that 
person's services as a principal. You should make a decision about 
whether to discontinue that person's services only after a thorough 
review to ensure that the action is proper and appropriate.
    (b) You may not begin to use the services of an excluded person as a 
principal under a covered transaction unless the Office of National Drug 
Control Policy grants an exception under Sec. 1404.120.



Sec. 1404.320  Must I verify that principals of my covered transactions
are eligible to participate?

    Yes, you as a participant are responsible for determining whether 
any of your principals of your covered transactions is excluded or 
disqualified from participating in the transaction. You may decide the 
method and frequency by which you do so. You may, but you are not 
required to, check the EPLS.



Sec. 1404.325  What happens if I do business with an excluded person
in a covered transaction?

    If as a participant you knowingly do business with an excluded 
person, we may disallow costs, annul or terminate the transaction, issue 
a stop work order, debar or suspend you, or take other remedies as 
appropriate.



Sec. 1404.330  What requirements must I pass down to persons at lower
tiers with whom I intend to do business?

    Before entering into a covered transaction with a participant at the 
next lower tier, you must require that participant to--
    (a) Comply with this subpart as a condition of participation in the 
transaction. You may do so using any method(s), unless Sec. 1404.440 
requires you to use specific methods.
    (b) Pass the requirement to comply with this subpart to each person 
with whom the participant enters into a covered transaction at the next 
lower tier.

            Disclosing Information--Primary Tier Participants



Sec. 1404.335  What information must I provide before entering into a
covered transaction with the Office of National Drug Control Policy?

    Before you enter into a covered transaction at the primary tier, you 
as the participant must notify the Office of National Drug Control 
Policy office that is entering into the transaction with you, if you 
know that you or any of the principals for that covered transaction:
    (a) Are presently excluded or disqualified;
    (b) Have been convicted within the preceding three years of any of 
the offenses listed in Sec. 1404.800(a) or had a civil judgment 
rendered against you for one of those offenses within that time period;
    (c) Are presently indicted for or otherwise criminally or civilly 
charged by a governmental entity (Federal, State or local) with 
commission of any of the offenses listed in Sec. 1404.800(a); or
    (d) Have had one or more public transactions (Federal, State, or 
local) terminated within the preceding three years for cause or default.



Sec. 1404.340  If I disclose unfavorable information required under
Sec. 1404.335, will I be prevented from participating in the 

transaction?

    As a primary tier participant, your disclosure of unfavorable 
information about yourself or a principal under Sec. 1404.335 will not 
necessarily cause us to deny your participation in the covered 
transaction. We will consider the information when we determine whether 
to enter into the covered transaction. We also will consider any 
additional information or explanation that you elect to submit with the 
disclosed information.

[[Page 292]]



Sec. 1404.345  What happens if I fail to disclose information required
under Sec. 1404.335?

    If we later determine that you failed to disclose information under 
Sec. 1404.335 that you knew at the time you entered into the covered 
transaction, we may--
    (a) Terminate the transaction for material failure to comply with 
the terms and conditions of the transaction; or
    (b) Pursue any other available remedies, including suspension and 
debarment.



Sec. 1404.350  What must I do if I learn of information required under
Sec. 1404.335 after entering into a covered transaction with the 

Office of National Drug Control Policy?

    At any time after you enter into a covered transaction, you must 
give immediate written notice to the Office of National Drug Control 
Policy office with which you entered into the transaction if you learn 
either that--
    (a) You failed to disclose information earlier, as required by Sec. 
1404.335; or
    (b) Due to changed circumstances, you or any of the principals for 
the transaction now meet any of the criteria in Sec. 1404.335.

             Disclosing Information--Lower Tier Participants



Sec. 1404.355  What information must I provide to a higher tier
participant before entering into a covered transaction with that 

participant?

    Before you enter into a covered transaction with a person at the 
next higher tier, you as a lower tier participant must notify that 
person if you know that you or any of the principals are presently 
excluded or disqualified.



Sec. 1404.360  What happens if I fail to disclose the information 
required under Sec. 1404.355?

    If we later determine that you failed to tell the person at the 
higher tier that you were excluded or disqualified at the time you 
entered into the covered transaction with that person, we may pursue any 
available remedies, including suspension and debarment.



Sec. 1404.365  What must I do if I learn of information required 
under Sec. 1404.355 after entering into a covered transaction with 

a higher tier participant?

    At any time after you enter into a lower tier covered transaction 
with a person at a higher tier, you must provide immediate written 
notice to that person if you learn either that--
    (a) You failed to disclose information earlier, as required by Sec. 
1404.355; or
    (b) Due to changed circumstances, you or any of the principals for 
the transaction now meet any of the criteria in Sec. 1404.355.



  Subpart D_Responsibilities of Office of National Drug Control Policy 
                    Officials Regarding Transactions



Sec. 1404.400  May I enter into a transaction with an excluded or 
disqualified person?

    (a) You as an agency official may not enter into a covered 
transaction with an excluded person unless you obtain an exception under 
Sec. 1404.120.
    (b) You may not enter into any transaction with a person who is 
disqualified from that transaction, unless you obtain a waiver or 
exception under the statute, Executive order, or regulation that is the 
basis for the person's disqualification.



Sec. 1404.405  May I enter into a covered transaction with a 
participant if a principal of the transaction is excluded?

    As an agency official, you may not enter into a covered transaction 
with a participant if you know that a principal of the transaction is 
excluded, unless you obtain an exception under Sec. 1404.120.



Sec. 1404.410  May I approve a participant's use of the services of 
an excluded person?

    After entering into a covered transaction with a participant, you as 
an agency official may not approve a participant's use of an excluded 
person as a principal under that transaction, unless you obtain an 
exception under Sec. 1404.120.

[[Page 293]]



Sec. 1404.415  What must I do if a Federal agency excludes the
participant or a principal after I enter into a covered transaction?

    (a) You as an agency official may continue covered transactions with 
an excluded person, or under which an excluded person is a principal, if 
the transactions were in existence when the person was excluded. You are 
not required to continue the transactions, however, and you may consider 
termination. You should make a decision about whether to terminate and 
the type of termination action, if any, only after a thorough review to 
ensure that the action is proper.
    (b) You may not renew or extend covered transactions (other than no-
cost time extensions) with any excluded person, or under which an 
excluded person is a principal, unless you obtain an exception under 
Sec. 1404.120.



Sec. 1404.420  May I approve a transaction with an excluded or 
disqualified person at a lower tier?

    If a transaction at a lower tier is subject to your approval, you as 
an agency official may not approve--
    (a) A covered transaction with a person who is currently excluded, 
unless you obtain an exception under Sec. 1404.120; or
    (b) A transaction with a person who is disqualified from that 
transaction, unless you obtain a waiver or exception under the statute, 
Executive order, or regulation that is the basis for the person's 
disqualification.



Sec. 1404.425  When do I check to see if a person is excluded or 
disqualified?

    As an agency official, you must check to see if a person is excluded 
or disqualified before you--
    (a) Enter into a primary tier covered transaction;
    (b) Approve a principal in a primary tier covered transaction;
    (c) Approve a lower tier participant if agency approval of the lower 
tier participant is required; or
    (d) Approve a principal in connection with a lower tier transaction 
if agency approval of the principal is required.



Sec. 1404.430  How do I check to see if a person is excluded or
disqualified?

    You check to see if a person is excluded or disqualified in two 
ways:
    (a) You as an agency official must check the EPLS when you take any 
action listed in Sec. 1404.425.
    (b) You must review information that a participant gives you, as 
required by Sec. 1404.335, about its status or the status of the 
principals of a transaction.



Sec. 1404.435  What must I require of a primary tier participant?

    You as an agency official must require each participant in a primary 
tier covered transaction to--
    (a) Comply with subpart C of this part as a condition of 
participation in the transaction; and
    (b) Communicate the requirement to comply with Subpart C of this 
part to persons at the next lower tier with whom the primary tier 
participant enters into covered transactions.



Sec. 1404.440  What method do I use to communicate those requirements
to participants?

    You must obtain certifications from participants that they will 
comply with subpart C of this part and that they will obtain similar 
certifications from lower-tier participants.

[68 FR 66581, Nov. 26, 2003]



Sec. 1404.445  What action may I take if a primary tier participant
knowingly does business with an excluded or disqualified person?

    If a participant knowingly does business with an excluded or 
disqualified person, you as an agency official may refer the matter for 
suspension and debarment consideration. You may also disallow costs, 
annul or terminate the transaction, issue a stop work order, or take any 
other appropriate remedy.



Sec. 1404.450  What action may I take if a primary tier participant
fails to disclose the information required under Sec. 1404.335?

    If you as an agency official determine that a participant failed to 
disclose information, as required by Sec. 1404.335, at the time it 
entered into a covered transaction with you, you may--

[[Page 294]]

    (a) Terminate the transaction for material failure to comply with 
the terms and conditions of the transaction; or
    (b) Pursue any other available remedies, including suspension and 
debarment.



Sec. 1404.455  What may I do if a lower tier participant fails to
disclose the information required under Sec. 1404.355 to the next 

higher tier?

    If you as an agency official determine that a lower tier participant 
failed to disclose information, as required by Sec. 1404.355, at the 
time it entered into a covered transaction with a participant at the 
next higher tier, you may pursue any remedies available to you, 
including the initiation of a suspension or debarment action.



                 Subpart E_Excluded Parties List System



Sec. 1404.500  What is the purpose of the Excluded Parties List System
(EPLS)?

    The EPLS is a widely available source of the most current 
information about persons who are excluded or disqualified from covered 
transactions.



Sec. 1404.505  Who uses the EPLS?

    (a) Federal agency officials use the EPLS to determine whether to 
enter into a transaction with a person, as required under Sec. 
1404.430.
    (b) Participants also may, but are not required to, use the EPLS to 
determine if--
    (1) Principals of their transactions are excluded or disqualified, 
as required under Sec. 1404.320; or
    (2) Persons with whom they are entering into covered transactions at 
the next lower tier are excluded or disqualified.
    (c) The EPLS is available to the general public.



Sec. 1404.510  Who maintains the EPLS?

    In accordance with the OMB guidelines, the General Services 
Administration (GSA) maintains the EPLS. When a Federal agency takes an 
action to exclude a person under the nonprocurement or procurement 
debarment and suspension system, the agency enters the information about 
the excluded person into the EPLS.



Sec. 1404.515  What specific information is in the EPLS?

    (a) At a minimum, the EPLS indicates--
    (1) The full name (where available) and address of each excluded or 
disqualified person, in alphabetical order, with cross references if 
more than one name is involved in a single action;
    (2) The type of action;
    (3) The cause for the action;
    (4) The scope of the action;
    (5) Any termination date for the action;
    (6) The agency and name and telephone number of the agency point of 
contact for the action; and
    (7) The Dun and Bradstreet Number (DUNS), or other similar code 
approved by the GSA, of the excluded or disqualified person, if 
available.
    (b)(1) The database for the EPLS includes a field for the Taxpayer 
Identification Number (TIN) (the social security number (SSN) for an 
individual) of an excluded or disqualified person.
    (2) Agencies disclose the SSN of an individual to verify the 
identity of an individual, only if permitted under the Privacy Act of 
1974 and, if appropriate, the Computer Matching and Privacy Protection 
Act of 1988, as codified in 5 U.S.C. 552(a).



Sec. 1404.520  Who places the information into the EPLS?

    Federal officials who take actions to exclude persons under this 
part or officials who are responsible for identifying disqualified 
persons must enter the following information about those persons into 
the EPLS:
    (a) Information required by Sec. 1404.515(a);
    (b) The Taxpayer Identification Number (TIN) of the excluded or 
disqualified person, including the social security number (SSN) for an 
individual, if the number is available and may be disclosed under law;
    (c) Information about an excluded or disqualified person, generally 
within five working days, after--
    (1) Taking an exclusion action;
    (2) Modifying or rescinding an exclusion action;

[[Page 295]]

    (3) Finding that a person is disqualified; or
    (4) Finding that there has been a change in the status of a person 
who is listed as disqualified.



Sec. 1404.525  Whom do I ask if I have questions about a person in the
EPLS?

    If you have questions about a person in the EPLS, ask the point of 
contact for the Federal agency that placed the person's name into the 
EPLS. You may find the agency point of contact from the EPLS.



Sec. 1404.530  Where can I find the EPLS?

    (a) You may access the EPLS through the Internet, currently at 
http://epls.arnet.gov.
    (b) As of November 26, 2003, you may also subscribe to a printed 
version. However, we anticipate discontinuing the printed version. Until 
it is discontinued, you may obtain the printed version by purchasing a 
yearly subscription from the Superintendent of Documents, U.S. 
Government Printing Office, Washington, DC 20402, or by calling the 
Government Printing Office Inquiry and Order Desk at (202) 783-3238.



   Subpart F_General Principles Relating to Suspension and Debarment 
                                 Actions



Sec. 1404.600  How do suspension and debarment actions start?

    When we receive information from any source concerning a cause for 
suspension or debarment, we will promptly report and investigate it. We 
refer the question of whether to suspend or debar you to our suspending 
or debarring official for consideration, if appropriate.



Sec. 1404.605  How does suspension differ from debarment?

    Suspension differs from debarment in that--

------------------------------------------------------------------------
      A suspending official . . .           A debarring official . . .
------------------------------------------------------------------------
(a) Imposes suspension as a temporary    Imposes debarment for a
 status of ineligibility for              specified period as a final
 procurement and nonprocurement           determination that a person is
 transactions, pending completion of an   not presently responsible.
 investigation or legal proceedings.
(b) Must--.............................  Must conclude, based on a
(1) Have adequate evidence that there     preponderance of the evidence,
 may be a cause for debarment of a        that the person has engaged in
 person; and.                             conduct that warrants
(2) Conclude that immediate action is     debarment.
 necessary to protect the Federal
 interest.
(c) Usually imposes the suspension       Imposes debarment after giving
 first, and then promptly notifies the    the respondent notice of the
 suspended person, giving the person an   action and an opportunity to
 opportunity to contest the suspension    contest the proposed
 and have it lifted.                      debarment.
------------------------------------------------------------------------



Sec. 1404.610  What procedures does the Office of National Drug Control
Policy use in suspension and debarment actions?

    In deciding whether to suspend or debar you, we handle the actions 
as informally as practicable, consistent with principles of fundamental 
fairness.
    (a) For suspension actions, we use the procedures in this subpart 
and subpart G of this part.
    (b) For debarment actions, we use the procedures in this subpart and 
subpart H of this part.



Sec. 1404.615  How does the Office of National Drug Control Policy 
notify a person of a suspension or debarment action?

    (a) The suspending or debarring official sends a written notice to 
the last known street address, facsimile number, or e-mail address of--
    (1) You or your identified counsel; or
    (2) Your agent for service of process, or any of your partners, 
officers, directors, owners, or joint venturers.
    (b) The notice is effective if sent to any of these persons.

[[Page 296]]



Sec. 1404.620  Do Federal agencies coordinate suspension and debarment
actions?

    Yes, when more than one Federal agency has an interest in a 
suspension or debarment, the agencies may consider designating one 
agency as the lead agency for making the decision. Agencies are 
encouraged to establish methods and procedures for coordinating their 
suspension and debarment actions.



Sec. 1404.625  What is the scope of a suspension or debarment?

    If you are suspended or debarred, the suspension or debarment is 
effective as follows:
    (a) Your suspension or debarment constitutes suspension or debarment 
of all of your divisions and other organizational elements from all 
covered transactions, unless the suspension or debarment decision is 
limited--
    (1) By its terms to one or more specifically identified individuals, 
divisions, or other organizational elements; or
    (2) To specific types of transactions.
    (b) Any affiliate of a participant may be included in a suspension 
or debarment action if the suspending or debarring official--
    (1) Officially names the affiliate in the notice; and
    (2) Gives the affiliate an opportunity to contest the action.



Sec. 1404.630  May the Office of National Drug Control Policy impute 
conduct of one person to another?

    For purposes of actions taken under this rule, we may impute conduct 
as follows:
    (a) Conduct imputed from an individual to an organization. We may 
impute the fraudulent, criminal, or other improper conduct of any 
officer, director, shareholder, partner, employee, or other individual 
associated with an organization, to that organization when the improper 
conduct occurred in connection with the individual's performance of 
duties for or on behalf of that organization, or with the organization's 
knowledge, approval or acquiescence. The organization's acceptance of 
the benefits derived from the conduct is evidence of knowledge, approval 
or acquiescence.
    (b) Conduct imputed from an organization to an individual, or 
between individuals. We may impute the fraudulent, criminal, or other 
improper conduct of any organization to an individual, or from one 
individual to another individual, if the individual to whom the improper 
conduct is imputed either participated in, had knowledge of, or reason 
to know of the improper conduct.
    (c) Conduct imputed from one organization to another organization. 
We may impute the fraudulent, criminal, or other improper conduct of one 
organization to another organization when the improper conduct occurred 
in connection with a partnership, joint venture, joint application, 
association or similar arrangement, or when the organization to whom the 
improper conduct is imputed has the power to direct, manage, control or 
influence the activities of the organization responsible for the 
improper conduct. Acceptance of the benefits derived from the conduct is 
evidence of knowledge, approval or acquiescence.



Sec. 1404.635  May the Office of National Drug Control Policy settle a
debarment or suspension action?

    Yes, we may settle a debarment or suspension action at any time if 
it is in the best interest of the Federal Government.



Sec. 1404.640  May a settlement include a voluntary exclusion?

    Yes, if we enter into a settlement with you in which you agree to be 
excluded, it is called a voluntary exclusion and has governmentwide 
effect.



Sec. 1404.645  Do other Federal agencies know if the Office of National
Drug Control Policy agrees to a voluntary exclusion?

    (a) Yes, we enter information regarding a voluntary exclusion into 
the EPLS.
    (b) Also, any agency or person may contact us to find out the 
details of a voluntary exclusion.

[[Page 297]]



                          Subpart G_Suspension



Sec. 1404.700  When may the suspending official issue a suspension?

    Suspension is a serious action. Using the procedures of this subpart 
and subpart F of this part, the suspending official may impose 
suspension only when that official determines that--
    (a) There exists an indictment for, or other adequate evidence to 
suspect, an offense listed under Sec. 1404.800(a), or
    (b) There exists adequate evidence to suspect any other cause for 
debarment listed under Sec. 1404.800(b) through (d); and
    (c) Immediate action is necessary to protect the public interest.



Sec. 1404.705  What does the suspending official consider in issuing 
a suspension?

    (a) In determining the adequacy of the evidence to support the 
suspension, the suspending official considers how much information is 
available, how credible it is given the circumstances, whether or not 
important allegations are corroborated, and what inferences can 
reasonably be drawn as a result. During this assessment, the suspending 
official may examine the basic documents, including grants, cooperative 
agreements, loan authorizations, contracts, and other relevant 
documents.
    (b) An indictment, conviction, civil judgment, or other official 
findings by Federal, State, or local bodies that determine factual and/
or legal matters, constitutes adequate evidence for purposes of 
suspension actions.
    (c) In deciding whether immediate action is needed to protect the 
public interest, the suspending official has wide discretion. For 
example, the suspending official may infer the necessity for immediate 
action to protect the public interest either from the nature of the 
circumstances giving rise to a cause for suspension or from potential 
business relationships or involvement with a program of the Federal 
Government.



Sec. 1404.710  When does a suspension take effect?

    A suspension is effective when the suspending official signs the 
decision to suspend.



Sec. 1404.715  What notice does the suspending official give me if I
am suspended?

    After deciding to suspend you, the suspending official promptly 
sends you a Notice of Suspension advising you--
    (a) That you have been suspended;
    (b) That your suspension is based on--
    (1) An indictment;
    (2) A conviction;
    (3) Other adequate evidence that you have committed irregularities 
which seriously reflect on the propriety of further Federal Government 
dealings with you; or
    (4) Conduct of another person that has been imputed to you, or your 
affiliation with a suspended or debarred person;
    (c) Of any other irregularities in terms sufficient to put you on 
notice without disclosing the Federal Government's evidence;
    (d) Of the cause(s) upon which we relied under Sec. 1404.700 for 
imposing suspension;
    (e) That your suspension is for a temporary period pending the 
completion of an investigation or resulting legal or debarment 
proceedings;
    (f) Of the applicable provisions of this subpart, Subpart F of this 
part, and any other Office of National Drug Control Policy procedures 
governing suspension decision making; and
    (g) Of the governmentwide effect of your suspension from procurement 
and nonprocurement programs and activities.



Sec. 1404.720  How may I contest a suspension?

    If you as a respondent wish to contest a suspension, you or your 
representative must provide the suspending official with information in 
opposition to the suspension. You may do this orally or in writing, but 
any information provided orally that you consider important must also be 
submitted in writing for the official record.



Sec. 1404.725  How much time do I have to contest a suspension?

    (a) As a respondent you or your representative must either send, or 
make rrangements to appear and present, the

[[Page 298]]

information and argument to the suspending official within 30 days after 
you receive the Notice of Suspension.
    (b) We consider the notice to be received by you--
    (1) When delivered, if we mail the notice to the last known street 
address, or five days after we send it if the letter is undeliverable;
    (2) When sent, if we send the notice by facsimile or five days after 
we send it if the facsimile is undeliverable; or
    (3) When delivered, if we send the notice by e-mail or five days 
after we send it if the e-mail is undeliverable.



Sec. 1404.730  What information must I provide to the suspending 
official if I contest a suspension?

    (a) In addition to any information and argument in opposition, as a 
respondent your submission to the suspending official must identify--
    (1) Specific facts that contradict the statements contained in the 
Notice of Suspension. A general denial is insufficient to raise a 
genuine dispute over facts material to the suspension;
    (2) All existing, proposed, or prior exclusions under regulations 
implementing E.O. 12549 and all similar actions taken by Federal, state, 
or local agencies, including administrative agreements that affect only 
those agencies;
    (3) All criminal and civil proceedings not included in the Notice of 
Suspension that grew out of facts relevant to the cause(s) stated in the 
notice; and
    (4) All of your affiliates.
    (b) If you fail to disclose this information, or provide false 
information, the Office of National Drug Control Policy may seek further 
criminal, civil or administrative action against you, as appropriate.



Sec. 1404.735  Under what conditions do I get an additional opportunity
to challenge the facts on which the suspension is based?

    (a) You as a respondent will not have an additional opportunity to 
challenge the facts if the suspending official determines that--
    (1) Your suspension is based upon an indictment, conviction, civil 
judgment, or other finding by a Federal, State, or local body for which 
an opportunity to contest the facts was provided;
    (2) Your presentation in opposition contains only general denials to 
information contained in the Notice of Suspension;
    (3) The issues raised in your presentation in opposition to the 
suspension are not factual in nature, or are not material to the 
suspending official's initial decision to suspend, or the official's 
decision whether to continue the suspension; or
    (4) On the basis of advice from the Department of Justice, an office 
of the United States Attorney, a State attorney general's office, or a 
State or local prosecutor's office, that substantial interests of the 
government in pending or contemplated legal proceedings based on the 
same facts as the suspension would be prejudiced by conducting fact-
finding.
    (b) You will have an opportunity to challenge the facts if the 
suspending official determines that--
    (1) The conditions in paragraph (a) of this section do not exist; 
and
    (2) Your presentation in opposition raises a genuine dispute over 
facts material to the suspension.
    (c) If you have an opportunity to challenge disputed material facts 
under this section, the suspending official or designee must conduct 
additional proceedings to resolve those facts.



Sec. 1404.740  Are suspension proceedings formal?

    (a) Suspension proceedings are conducted in a fair and informal 
manner. The suspending official may use flexible procedures to allow you 
to present matters in opposition. In so doing, the suspending official 
is not required to follow formal rules of evidence or procedure in 
creating an official record upon which the official will base a final 
suspension decision.
    (b) You as a respondent or your representative must submit any 
documentary evidence you want the suspending official to consider.



Sec. 1404.745  How is fact-finding conducted?

    (a) If fact-finding is conducted--
    (1) You may present witnesses and other evidence, and confront any 
witness presented; and

[[Page 299]]

    (2) The fact-finder must prepare written findings of fact for the 
record.
    (b) A transcribed record of fact-finding proceedings must be made, 
unless you as a respondent and the Office of National Drug Control 
Policy agree to waive it in advance. If you want a copy of the 
transcribed record, you may purchase it.



Sec. 1404.750  What does the suspending official consider in deciding 
whether to continue or terminate my suspension?

    (a) The suspending official bases the decision on all information 
contained in the official record. The record includes--
    (1) All information in support of the suspending official's initial 
decision to suspend you;
    (2) Any further information and argument presented in support of, or 
opposition to, the suspension; and
    (3) Any transcribed record of fact-finding proceedings.
    (b) The suspending official may refer disputed material facts to 
another official for findings of fact. The suspending official may 
reject any resulting findings, in whole or in part, only after 
specifically determining them to be arbitrary, capricious, or clearly 
erroneous.



Sec. 1404.755  When will I know whether the suspension is continued or
terminated?

    The suspending official must make a written decision whether to 
continue, modify, or terminate your suspension within 45 days of closing 
the official record. The official record closes upon the suspending 
official's receipt of final submissions, information and findings of 
fact, if any. The suspending official may extend that period for good 
cause.



Sec. 1404.760  How long may my suspension last?

    (a) If legal or debarment proceedings are initiated at the time of, 
or during your suspension, the suspension may continue until the 
conclusion of those proceedings. However, if proceedings are not 
initiated, a suspension may not exceed 12 months.
    (b) The suspending official may extend the 12 month limit under 
paragraph (a) of this section for an additional 6 months if an office of 
a U.S. Assistant Attorney General, U.S. Attorney, or other responsible 
prosecuting official requests an extension in writing. In no event may a 
suspension exceed 18 months without initiating proceedings under 
paragraph (a) of this section.
    (c) The suspending official must notify the appropriate officials 
under paragraph (b) of this section of an impending termination of a 
suspension at least 30 days before the 12 month period expires to allow 
the officials an opportunity to request an extension.



                           Subpart H_Debarment



Sec. 1404.800  What are the causes for debarment?

    We may debar a person for--
    (a) Conviction of or civil judgment for--
    (1) Commission of fraud or a criminal offense in connection with 
obtaining, attempting to obtain, or performing a public or private 
agreement or transaction;
    (2) Violation of Federal or State antitrust statutes, including 
those proscribing price fixing between competitors, allocation of 
customers between competitors, and bid rigging;
    (3) Commission of embezzlement, theft, forgery, bribery, 
falsification or destruction of records, making false statements, tax 
evasion, receiving stolen property, making false claims, or obstruction 
of justice; or
    (4) Commission of any other offense indicating a lack of business 
integrity or business honesty that seriously and directly affects your 
present responsibility;
    (b) Violation of the terms of a public agreement or transaction so 
serious as to affect the integrity of an agency program, such as--
    (1) A willful failure to perform in accordance with the terms of one 
or more public agreements or transactions;
    (2) A history of failure to perform or of unsatisfactory performance 
of one or more public agreements or transactions; or
    (3) A willful violation of a statutory or regulatory provision or 
requirement applicable to a public agreement or transaction;

[[Page 300]]

    (c) Any of the following causes:
    (1) A nonprocurement debarment by any Federal agency taken before 
October 1, 1988, or a procurement debarment by any Federal agency taken 
pursuant to 48 CFR part 9, subpart 9.4, before August 25, 1995;
    (2) Knowingly doing business with an ineligible person, except as 
permitted under Sec. 1404.120;
    (3) Failure to pay a single substantial debt, or a number of 
outstanding debts (including disallowed costs and overpayments, but not 
including sums owed the Federal Government under the Internal Revenue 
Code) owed to any Federal agency or instrumentality, provided the debt 
is uncontested by the debtor or, if contested, provided that the 
debtor's legal and administrative remedies have been exhausted;
    (4) Violation of a material provision of a voluntary exclusion 
agreement entered into under Sec. 1404.640 or of any settlement of a 
debarment or suspension action; or
    (5) Violation of the provisions of the Drug-Free Workplace Act of 
1988 (41 U.S.C. 701); or
    (d) Any other cause of so serious or compelling a nature that it 
affects your present responsibility.



Sec. 1404.805  What notice does the debarring official give me if I am
proposed for debarment?

    After consideration of the causes in Sec. 1404.800 of this subpart, 
if the debarring official proposes to debar you, the official sends you 
a Notice of Proposed Debarment, pursuant to Sec. 1404.615, advising 
you--
    (a) That the debarring official is considering debarring you;
    (b) Of the reasons for proposing to debar you in terms sufficient to 
put you on notice of the conduct or transactions upon which the proposed 
debarment is based;
    (c) Of the cause(s) under Sec. 1404.800 upon which the debarring 
official relied for proposing your debarment;
    (d) Of the applicable provisions of this subpart, Subpart F of this 
part, and any other Office of National Drug Control Policy procedures 
governing debarment; and
    (e) Of the governmentwide effect of a debarment from procurement and 
nonprocurement programs and activities.



Sec. 1404.810  When does a debarment take effect?

    A debarment is not effective until the debarring official issues a 
decision. The debarring official does not issue a decision until the 
respondent has had an opportunity to contest the proposed debarment.



Sec. 1404.815  How may I contest a proposed debarment?

    If you as a respondent wish to contest a proposed debarment, you or 
your representative must provide the debarring official with information 
in opposition to the proposed debarment. You may do this orally or in 
writing, but any information provided orally that you consider important 
must also be submitted in writing for the official record.



Sec. 1404.820  How much time do I have to contest a proposed debarment?

    (a) As a respondent you or your representative must either send, or 
make arrangements to appear and present, the information and argument to 
the debarring official within 30 days after you receive the Notice of 
Proposed Debarment.
    (b) We consider the Notice of Proposed Debarment to be received by 
you--
    (1) When delivered, if we mail the notice to the last known street 
address, or five days after we send it if the letter is undeliverable;
    (2) When sent, if we send the notice by facsimile or five days after 
we send it if the facsimile is undeliverable; or
    (3) When delivered, if we send the notice by e-mail or five days 
after we send it if the e-mail is undeliverable.



Sec. 1404.825  What information must I provide to the debarring official
if I contest a proposed debarment?

    (a) In addition to any information and argument in opposition, as a 
respondent your submission to the debarring official must identify--
    (1) Specific facts that contradict the statements contained in the 
Notice of

[[Page 301]]

Proposed Debarment. Include any information about any of the factors 
listed in Sec. 1404.860. A general denial is insufficient to raise a 
genuine dispute over facts material to the debarment;
    (2) All existing, proposed, or prior exclusions under regulations 
implementing E.O. 12549 and all similar actions taken by Federal, State, 
or local agencies, including administrative agreements that affect only 
those agencies;
    (3) All criminal and civil proceedings not included in the Notice of 
Proposed Debarment that grew out of facts relevant to the cause(s) 
stated in the notice; and
    (4) All of your affiliates.
    (b) If you fail to disclose this information, or provide false 
information, the Office of National Drug Control Policy may seek further 
criminal, civil or administrative action against you, as appropriate.



Sec. 1404.830  Under what conditions do I get an additional opportunity
to challenge the facts on which a proposed debarment is based?

    (a) You as a respondent will not have an additional opportunity to 
challenge the facts if the debarring official determines that--
    (1) Your debarment is based upon a conviction or civil judgment;
    (2) Your presentation in opposition contains only general denials to 
information contained in the Notice of Proposed Debarment; or
    (3) The issues raised in your presentation in opposition to the 
proposed debarment are not factual in nature, or are not material to the 
debarring official's decision whether to debar.
    (b) You will have an additional opportunity to challenge the facts 
if the debarring official determines that--
    (1) The conditions in paragraph (a) of this section do not exist; 
and
    (2) Your presentation in opposition raises a genuine dispute over 
facts material to the proposed debarment.
    (c) If you have an opportunity to challenge disputed material facts 
under this section, the debarring official or designee must conduct 
additional proceedings to resolve those facts.



Sec. 1404.835  Are debarment proceedings formal?

    (a) Debarment proceedings are conducted in a fair and informal 
manner. The debarring official may use flexible procedures to allow you 
as a respondent to present matters in opposition. In so doing, the 
debarring official is not required to follow formal rules of evidence or 
procedure in creating an official record upon which the official will 
base the decision whether to debar.
    (b) You or your representative must submit any documentary evidence 
you want the debarring official to consider.



Sec. 1404.840  How is fact-finding conducted?

    (a) If fact-finding is conducted--
    (1) You may present witnesses and other evidence, and confront any 
witness presented; and
    (2) The fact-finder must prepare written findings of fact for the 
record.
    (b) A transcribed record of fact-finding proceedings must be made, 
unless you as a respondent and the Office of National Drug Control 
Policy agree to waive it in advance. If you want a copy of the 
transcribed record, you may purchase it.



Sec. 1404.845  What does the debarring official consider in deciding 
whether to debar me?

    (a) The debarring official may debar you for any of the causes in 
Sec. 1404.800. However, the official need not debar you even if a cause 
for debarment exists. The official may consider the seriousness of your 
acts or omissions and the mitigating or aggravating factors set forth at 
Sec. 1404.860.
    (b) The debarring official bases the decision on all information 
contained in the official record. The record includes--
    (1) All information in support of the debarring official's proposed 
debarment;
    (2) Any further information and argument presented in support of, or 
in opposition to, the proposed debarment; and
    (3) Any transcribed record of fact-finding proceedings.
    (c) The debarring official may refer disputed material facts to 
another official for findings of fact. The debarring

[[Page 302]]

official may reject any resultant findings, in whole or in part, only 
after specifically determining them to be arbitrary, capricious, or 
clearly erroneous.



Sec. 1404.850  What is the standard of proof in a debarment action?

    (a) In any debarment action, we must establish the cause for 
debarment by a preponderance of the evidence.
    (b) If the proposed debarment is based upon a conviction or civil 
judgment, the standard of proof is met.



Sec. 1404.855  Who has the burden of proof in a debarment action?

    (a) We have the burden to prove that a cause for debarment exists.
    (b) Once a cause for debarment is established, you as a respondent 
have the burden of demonstrating to the satisfaction of the debarring 
official that you are presently responsible and that debarment is not 
necessary.



Sec. 1404.860  What factors may influence the debarring official's 
decision?

    This section lists the mitigating and aggravating factors that the 
debarring official may consider in determining whether to debar you and 
the length of your debarment period. The debarring official may consider 
other factors if appropriate in light of the circumstances of a 
particular case. The existence or nonexistence of any factor, such as 
one of those set forth in this section, is not necessarily determinative 
of your present responsibility. In making a debarment decision, the 
debarring official may consider the following factors:
    (a) The actual or potential harm or impact that results or may 
result from the wrongdoing.
    (b) The frequency of incidents and/or duration of the wrongdoing.
    (c) Whether there is a pattern or prior history of wrongdoing. For 
example, if you have been found by another Federal agency or a State 
agency to have engaged in wrongdoing similar to that found in the 
debarment action, the existence of this fact may be used by the 
debarring official in determining that you have a pattern or prior 
history of wrongdoing.
    (d) Whether you are or have been excluded or disqualified by an 
agency of the Federal Government or have not been allowed to participate 
in State or local contracts or assistance agreements on a basis of 
conduct similar to one or more of the causes for debarment specified in 
this part.
    (e) Whether you have entered into an administrative agreement with a 
Federal agency or a State or local government that is not governmentwide 
but is based on conduct similar to one or more of the causes for 
debarment specified in this part.
    (f) Whether and to what extent you planned, initiated, or carried 
out the wrongdoing.
    (g) Whether you have accepted responsibility for the wrongdoing and 
recognize the seriousness of the misconduct that led to the cause for 
debarment.
    (h) Whether you have paid or agreed to pay all criminal, civil and 
administrative liabilities for the improper activity, including any 
investigative or administrative costs incurred by the government, and 
have made or agreed to make full restitution.
    (i) Whether you have cooperated fully with the government agencies 
during the investigation and any court or administrative action. In 
determining the extent of cooperation, the debarring official may 
consider when the cooperation began and whether you disclosed all 
pertinent information known to you.
    (j) Whether the wrongdoing was pervasive within your organization.
    (k) The kind of positions held by the individuals involved in the 
wrongdoing.
    (l) Whether your organization took appropriate corrective action or 
remedial measures, such as establishing ethics training and implementing 
programs to prevent recurrence.
    (m) Whether your principals tolerated the offense.
    (n) Whether you brought the activity cited as a basis for the 
debarment to the attention of the appropriate government agency in a 
timely manner.
    (o) Whether you have fully investigated the circumstances 
surrounding the cause for debarment and, if so, made the result of the 
investigation available to the debarring official.

[[Page 303]]

    (p) Whether you had effective standards of conduct and internal 
control systems in place at the time the questioned conduct occurred.
    (q) Whether you have taken appropriate disciplinary action against 
the individuals responsible for the activity which constitutes the cause 
for debarment.
    (r) Whether you have had adequate time to eliminate the 
circumstances within your organization that led to the cause for the 
debarment.
    (s) Other factors that are appropriate to the circumstances of a 
particular case.



Sec. 1404.865  How long may my debarment last?

    (a) If the debarring official decides to debar you, your period of 
debarment will be based on the seriousness of the cause(s) upon which 
your debarment is based. Generally, debarment should not exceed three 
years. However, if circumstances warrant, the debarring official may 
impose a longer period of debarment.
    (b) In determining the period of debarment, the debarring official 
may consider the factors in Sec. 1404.860. If a suspension has preceded 
your debarment, the debarring official must consider the time you were 
suspended.
    (c) If the debarment is for a violation of the provisions of the 
Drug-Free Workplace Act of 1988, your period of debarment may not exceed 
five years.



Sec. 1404.870  When do I know if the debarring official debars me?

    (a) The debarring official must make a written decision whether to 
debar within 45 days of closing the official record. The official record 
closes upon the debarring official's receipt of final submissions, 
information and findings of fact, if any. The debarring official may 
extend that period for good cause.
    (b) The debarring official sends you written notice, pursuant to 
Sec. 1404.615 that the official decided, either--
    (1) Not to debar you; or
    (2) To debar you. In this event, the notice:
    (i) Refers to the Notice of Proposed Debarment;
    (ii) Specifies the reasons for your debarment;
    (iii) States the period of your debarment, including the effective 
dates; and
    (iv) Advises you that your debarment is effective for covered 
transactions and contracts that are subject to the Federal Acquisition 
Regulation (48 CFR chapter 1), throughout the executive branch of the 
Federal Government unless an agency head or an authorized designee 
grants an exception.



Sec. 1404.875  May I ask the debarring official to reconsider a 
decision to debar me?

    Yes, as a debarred person you may ask the debarring official to 
reconsider the debarment decision or to reduce the time period or scope 
of the debarment. However, you must put your request in writing and 
support it with documentation.



Sec. 1404.880  What factors may influence the debarring official during
reconsideration?

    The debarring official may reduce or terminate your debarment based 
on--
    (a) Newly discovered material evidence;
    (b) A reversal of the conviction or civil judgment upon which your 
debarment was based;
    (c) A bona fide change in ownership or management;
    (d) Elimination of other causes for which the debarment was imposed; 
or
    (e) Other reasons the debarring official finds appropriate.



Sec. 1404.885  May the debarring official extend a debarment?

    (a) Yes, the debarring official may extend a debarment for an 
additional period, if that official determines that an extension is 
necessary to protect the public interest.
    (b) However, the debarring official may not extend a debarment 
solely on the basis of the facts and circumstances upon which the 
initial debarment action was based.
    (c) If the debarring official decides that a debarment for an 
additional period is necessary, the debarring official must follow the 
applicable procedures in this subpart, and subpart F of this part, to 
extend the debarment.

[[Page 304]]



                          Subpart I_Definitions



Sec. 1404.900  Adequate evidence.

    Adequate evidence means information sufficient to support the 
reasonable belief that a particular act or omission has occurred.



Sec. 1404.905  Affiliate.

    Persons are affiliates of each other if, directly or indirectly, 
either one controls or has the power to control the other or a third 
person controls or has the power to control both. The ways we use to 
determine control include, but are not limited to--
    (a) Interlocking management or ownership;
    (b) Identity of interests among family members;
    (c) Shared facilities and equipment;
    (d) Common use of employees; or
    (e) A business entity which has been organized following the 
exclusion of a person which has the same or similar management, 
ownership, or principal employees as the excluded person.



Sec. 1404.910  Agency.

    Agency means any United States executive department, military 
department, defense agency, or any other agency of the executive branch. 
Other agencies of the Federal government are not considered ``agencies'' 
for the purposes of this part unless they issue regulations adopting the 
governmentwide Debarment and Suspension system under Executive orders 
12549 and 12689.



Sec. 1404.915  Agent or representative.

    Agent or representative means any person who acts on behalf of, or 
who is authorized to commit, a participant in a covered transaction.



Sec. 1404.920  Civil judgment.

    Civil judgment means the disposition of a civil action by any court 
of competent jurisdiction, whether by verdict, decision, settlement, 
stipulation, other disposition which creates a civil liability for the 
complained of wrongful acts, or a final determination of liability under 
the Program Fraud Civil Remedies Act of 1988 (31 U.S.C. 3801-3812).



Sec. 1404.925  Conviction.

    Conviction means--
    (a) A judgment or any other determination of guilt of a criminal 
offense by any court of competent jurisdiction, whether entered upon a 
verdict or plea, including a plea of nolo contendere; or
    (b) Any other resolution that is the functional equivalent of a 
judgment, including probation before judgment and deferred prosecution. 
A disposition without the participation of the court is the functional 
equivalent of a judgment only if it includes an admission of guilt.



Sec. 1404.930  Debarment.

    Debarment means an action taken by a debarring official under 
subpart H of this part to exclude a person from participating in covered 
transactions and transactions covered under the Federal Acquisition 
Regulation (48 CFR chapter 1). A person so excluded is debarred.



Sec. 1404.935  Debarring official.

    (a) Debarring official means an agency official who is authorized to 
impose debarment. A debarring official is either--
    (1) The agency head; or
    (2) An official designated by the agency head.
    (b) [Reserved]



Sec. 1404.940  Disqualified.

    Disqualified means that a person is prohibited from participating in 
specified Federal procurement or nonprocurement transactions as required 
under a statute, Executive order (other than Executive Orders 12549 and 
12689) or other authority. Examples of disqualifications include persons 
prohibited under--
    (a) The Davis-Bacon Act (40 U.S.C. 276(a));
    (b) The equal employment opportunity acts and Executive orders; or
    (c) The Clean Air Act (42 U.S.C. 7606), Clean Water Act (33 U.S.C. 
1368) and Executive Order 11738 (3 CFR, 1973 Comp., p. 799).



Sec. 1404.945  Excluded or exclusion.

    Excluded or exclusion means--
    (a) That a person or commodity is prohibited from being a 
participant in

[[Page 305]]

covered transactions, whether the person has been suspended; debarred; 
proposed for debarment under 48 CFR part 9, subpart 9.4; voluntarily 
excluded; or
    (b) The act of excluding a person.



Sec. 1404.950  Excluded Parties List System

    Excluded Parties List System (EPLS) means the list maintained and 
disseminated by the General Services Administration (GSA) containing the 
names and other information about persons who are ineligible. The EPLS 
system includes the printed version entitled, ``List of Parties Excluded 
or Disqualified from Federal Procurement and Nonprocurement Programs,'' 
so long as published.



Sec. 1404.955  Indictment.

    Indictment means an indictment for a criminal offense. A 
presentment, information, or other filing by a competent authority 
charging a criminal offense shall be given the same effect as an 
indictment.



Sec. 1404.960  Ineligible or ineligibility.

    Ineligible or ineligibility means that a person or commodity is 
prohibited from covered transactions because of an exclusion or 
disqualification.



Sec. 1404.965  Legal proceedings.

    Legal proceedings means any criminal proceeding or any civil 
judicial proceeding, including a proceeding under the Program Fraud 
Civil Remedies Act (31 U.S.C. 3801-3812), to which the Federal 
Government or a State or local government or quasi-governmental 
authority is a party. The term also includes appeals from those 
proceedings.



Sec. 1404.970  Nonprocurement transaction.

    (a) Nonprocurement transaction means any transaction, regardless of 
type (except procurement contracts), including, but not limited to the 
following:
    (1) Grants.
    (2) Cooperative agreements.
    (3) Scholarships.
    (4) Fellowships.
    (5) Contracts of assistance.
    (6) Loans.
    (7) Loan guarantees.
    (8) Subsidies.
    (9) Insurances.
    (10) Payments for specified uses.
    (11) Donation agreements.
    (b) A nonprocurement transaction at any tier does not require the 
transfer of Federal funds.



Sec. 1404.975  Notice.

    Notice means a written communication served in person, sent by 
certified mail or its equivalent, or sent electronically by e-mail or 
facsimile. (See Sec. 1404. 615.)



Sec. 1404.980  Participant.

    Participant means any person who submits a proposal for or who 
enters into a covered transaction, including an agent or representative 
of a participant.



Sec. 1404.985  Person.

    Person means any individual, corporation, partnership, association, 
unit of government, or legal entity, however organized.



Sec. 1404.990  Preponderance of the evidence.

    Preponderance of the evidence means proof by information that, 
compared with information opposing it, leads to the conclusion that the 
fact at issue is more probably true than not.



Sec. 1404.995  Principal.

    Principal means--
    (a) An officer, director, owner, partner, principal investigator, or 
other person within a participant with management or supervisory 
responsibilities related to a covered transaction; or
    (b) A consultant or other person, whether or not employed by the 
participant or paid with Federal funds, who--
    (1) Is in a position to handle Federal funds;
    (2) Is in a position to influence or control the use of those funds; 
or,
    (3) Occupies a technical or professional position capable of 
substantially influencing the development or outcome of an activity 
required to perform the covered transaction.



Sec. 1404.1000  Respondent.

    Respondent means a person against whom an agency has initiated a 
debarment or suspension action.

[[Page 306]]



Sec. 1404.1005  State.

    (a) State means--
    (1) Any of the states of the United States;
    (2) The District of Columbia;
    (3) The Commonwealth of Puerto Rico;
    (4) Any territory or possession of the United States; or
    (5) Any agency or instrumentality of a state.
    (b) For purposes of this part, State does not include institutions 
of higher education, hospitals, or units of local government.



Sec. 1404.1010  Suspending official.

    (a) Suspending official means an agency official who is authorized 
to impose suspension. The suspending official is either:
    (1) The agency head; or
    (2) An official designated by the agency head.
    (b) [Reserved]



Sec. 1404.1015  Suspension.

    Suspension is an action taken by a suspending official under subpart 
G of this part that immediately prohibits a person from participating in 
covered transactions and transactions covered under the Federal 
Acquisition Regulation (48 CFR chapter 1) for a temporary period, 
pending completion of an agency investigation and any judicial or 
administrative proceedings that may ensue. A person so excluded is 
suspended.



Sec. 1404.1020  Voluntary exclusion or voluntarily excluded.

    (a) Voluntary exclusion means a person's agreement to be excluded 
under the terms of a settlement between the person and one or more 
agencies. Voluntary exclusion must have governmentwide effect.
    (b) Voluntarily excluded means the status of a person who has agreed 
to a voluntary exclusion.

Subpart J [Reserved]

[[Page 307]]



            Sec. Appendix to Part 1404--Covered Transactions
[GRAPHIC] [TIFF OMITTED] TR26NO03.000



PART 1405_GOVERNMENTWIDE REQUIREMENTS FOR DRUG-FREE WORKPLACE 
(FINANCIAL ASSISTANCE)--Table of Contents



                     Subpart A_Purpose and Coverage

Sec.
1405.100 What does this part do?
1405.105 Does this part apply to me?
1405.110 Are any of my Federal assistance awards exempt from this part?
1405.115 Does this part affect the Federal contracts that I receive?

      Subpart B_Requirements for Recipients Other Than Individuals

1405.200 What must I do to comply with this part?
1405.205 What must I include in my drug-free workplace statement?
1405.210 To whom must I distribute my drug-free workplace statement?
1405.215 What must I include in my drug-free awareness program?
1405.220 By when must I publish my drug-free workplace statement and 
          establish my drug-free awareness program?
1405.225 What actions must I take concerning employees who are convicted 
          of drug violations in the workplace?
1405.230 How and when must I identify workplaces?

        Subpart C_Requirements for Recipients Who Are Individuals

1405.300 What must I do to comply with this part if I am an individual 
          recipient?

[[Page 308]]

1405.301 [Reserved]

  Subpart D_Responsibilities of Office of National Drug Control Policy 
                           Awarding Officials

1405.400 What are my responsibilities as an Office of National Drug 
          Control Policy awarding official?

           Subpart E_Violations of This Part and Consequences

1405.500 How are violations of this part determined for recipients other 
          than individuals?
1405.505 How are violations of this part determined for recipients who 
          are individuals?
1405.510 What actions will the Federal Government take against a 
          recipient determined to have violated this part?
1405.515 Are there exceptions to those actions?

                          Subpart F_Definitions

1405.605 Award.
1405.610 Controlled substance.
1405.615 Conviction.
1405.620 Cooperative agreement.
1405.625 Criminal drug statute.
1405.630 Debarment.
1405.635 Drug-free workplace.
1405.640 Employee.
1405.645 Federal agency or agency.
1405.650 Grant.
1405.655 Individual.
1405.660 Recipient.
1405.665 State.
1405.670 Suspension.

    Authority: 21 U.S.C. 1701; 41 U.S.C. 701, et seq.

    Source: 68 FR 66557, 66581, 66582, Nov. 26, 2003, unless otherwise 
noted.



                     Subpart A_Purpose and Coverage



Sec. 1405.100  What does this part do?

    This part carries out the portion of the Drug-Free Workplace Act of 
1988 (41 U.S.C. 701 et seq., as amended) that applies to grants. It also 
applies the provisions of the Act to cooperative agreements and other 
financial assistance awards, as a matter of Federal Government policy.



Sec. 1405.105  Does this part apply to me?

    (a) Portions of this part apply to you if you are either--
    (1) A recipient of an assistance award from the Office of National 
Drug Control Policy; or
    (2) A(n) Office of National Drug Control Policy awarding official. 
(See definitions of award and recipient in Sec. Sec. 1405.605 and 
1405.660, respectively.)
    (b) The following table shows the subparts that apply to you:

------------------------------------------------------------------------
            If you are . . .                    see subparts . . .
------------------------------------------------------------------------
(1) A recipient who is not an            A, B and E.
 individual.
(2) A recipient who is an individual...  A, C and E.
(3) A(n) Office of National Drug         A, D and E.
 Control Policy awarding official.
------------------------------------------------------------------------



Sec. 1405.110  Are any of my Federal assistance awards exempt from this
part?

    This part does not apply to any award that the Director of National 
Drug Control Policy determines that the application of this part would 
be inconsistent with the international obligations of the United States 
or the laws or regulations of a foreign government.



Sec. 1405.115  Does this part affect the Federal contracts that I receive?

    It will affect future contract awards indirectly if you are debarred 
or suspended for a violation of the requirements of this part, as 
described in Sec. 1405.510(c). However, this part does not apply 
directly to procurement contracts. The portion of the Drug-Free 
Workplace Act of 1988 that applies to Federal procurement contracts is 
carried out through the Federal Acquisition Regulation in chapter 1 of 
Title 48 of the Code of Federal Regulations (the drug-free workplace 
coverage currently is in 48 CFR part 23, subpart 23.5).

[[Page 309]]



      Subpart B_Requirements for Recipients Other Than Individuals



Sec. 1405.200  What must I do to comply with this part?

    There are two general requirements if you are a recipient other than 
an individual.
    (a) First, you must make a good faith effort, on a continuing basis, 
to maintain a drug-free workplace. You must agree to do so as a 
condition for receiving any award covered by this part. The specific 
measures that you must take in this regard are described in more detail 
in subsequent sections of this subpart. Briefly, those measures are to--
    (1) Publish a drug-free workplace statement and establish a drug-
free awareness program for your employees (see Sec. Sec. 1405.205 
through 1405.220); and
    (2) Take actions concerning employees who are convicted of violating 
drug statutes in the workplace (see Sec. 1405.225).
    (b) Second, you must identify all known workplaces under your 
Federal awards (see Sec. 1405.230).



Sec. 1405.205  What must I include in my drug-free workplace 
statement?

    You must publish a statement that--
    (a) Tells your employees that the unlawful manufacture, 
distribution, dispensing, possession, or use of a controlled substance 
is prohibited in your workplace;
    (b) Specifies the actions that you will take against employees for 
violating that prohibition; and
    (c) Lets each employee know that, as a condition of employment under 
any award, he or she:
    (1) Will abide by the terms of the statement; and
    (2) Must notify you in writing if he or she is convicted for a 
violation of a criminal drug statute occurring in the workplace and must 
do so no more than five calendar days after the conviction.



Sec. 1405.210  To whom must I distribute my drug-free workplace 
statement?

    You must require that a copy of the statement described in Sec. 
1405.205 be given to each employee who will be engaged in the 
performance of any Federal award.



Sec. 1405.215  What must I include in my drug-free awareness program?

    You must establish an ongoing drug-free awareness program to inform 
employees about--
    (a) The dangers of drug abuse in the workplace;
    (b) Your policy of maintaining a drug-free workplace;
    (c) Any available drug counseling, rehabilitation, and employee 
assistance programs; and
    (d) The penalties that you may impose upon them for drug abuse 
violations occurring in the workplace.



Sec. 1405.220  By when must I publish my drug-free workplace statement
and establish my drug-free awareness program?

    If you are a new recipient that does not already have a policy 
statement as described in Sec. 1405.205 and an ongoing awareness 
program as described in Sec. 1405.215, you must publish the statement 
and establish the program by the time given in the following table:

------------------------------------------------------------------------
                If . . .                          then you . . .
------------------------------------------------------------------------
(a) The performance period of the award  must have the policy statement
 is less than 30 days.                    and program in place as soon
                                          as possible, but before the
                                          date on which performance is
                                          expected to be completed.
(b) The performance period of the award  must have the policy statement
 is 30 days or more.                      and program in place within 30
                                          days after award.
(c) You believe there are extraordinary  may ask the Office of National
 circumstances that will require more     Drug Control Policy awarding
 than 30 days for you to publish the      official to give you more time
 policy statement and establish the       to do so. The amount of
 awareness program.                       additional time, if any, to be
                                          given is at the discretion of
                                          the awarding official.
------------------------------------------------------------------------


[[Page 310]]



Sec. 1405.225  What actions must I take concerning employees who are
convicted of drug violations in the workplace?

    There are two actions you must take if an employee is convicted of a 
drug violation in the workplace:
    (a) First, you must notify Federal agencies if an employee who is 
engaged in the performance of an award informs you about a conviction, 
as required by Sec. 1405.205(c)(2), or you otherwise learn of the 
conviction. Your notification to the Federal agencies must--
    (1) Be in writing;
    (2) Include the employee's position title;
    (3) Include the identification number(s) of each affected award;
    (4) Be sent within ten calendar days after you learn of the 
conviction; and
    (5) Be sent to every Federal agency on whose award the convicted 
employee was working. It must be sent to every awarding official or his 
or her official designee, unless the Federal agency has specified a 
central point for the receipt of the notices.
    (b) Second, within 30 calendar days of learning about an employee's 
conviction, you must either--
    (1) Take appropriate personnel action against the employee, up to 
and including termination, consistent with the requirements of the 
Rehabilitation Act of 1973 (29 U.S.C. 794), as amended; or
    (2) Require the employee to participate satisfactorily in a drug 
abuse assistance or rehabilitation program approved for these purposes 
by a Federal, State or local health, law enforcement, or other 
appropriate agency.



Sec. 1405.230  How and when must I identify workplaces?

    (a) You must identify all known workplaces under each Office of 
National Drug Control Policy award. A failure to do so is a violation of 
your drug-free workplace requirements. You may identify the workplaces--
    (1) To the Office of National Drug Control Policy official that is 
making the award, either at the time of application or upon award; or
    (2) In documents that you keep on file in your offices during the 
performance of the award, in which case you must make the information 
available for inspection upon request by Office of National Drug Control 
Policy officials or their designated representatives.
    (b) Your workplace identification for an award must include the 
actual address of buildings (or parts of buildings) or other sites where 
work under the award takes place. Categorical descriptions may be used 
(e.g., all vehicles of a mass transit authority or State highway 
department while in operation, State employees in each local 
unemployment office, performers in concert halls or radio studios).
    (c) If you identified workplaces to the Office of National Drug 
Control Policy awarding official at the time of application or award, as 
described in paragraph (a)(1) of this section, and any workplace that 
you identified changes during the performance of the award, you must 
inform the Office of National Drug Control Policy awarding official.



        Subpart C_Requirements for Recipients Who Are Individuals



Sec. 1405.300  What must I do to comply with this part if I am an
individual recipient?

    As a condition of receiving a(n) Office of National Drug Control 
Policy award, if you are an individual recipient, you must agree that--
    (a) You will not engage in the unlawful manufacture, distribution, 
dispensing, possession, or use of a controlled substance in conducting 
any activity related to the award; and
    (b) If you are convicted of a criminal drug offense resulting from a 
violation occurring during the conduct of any award activity, you will 
report the conviction:
    (1) In writing.
    (2) Within 10 calendar days of the conviction.
    (3) To the Office of National Drug Control Policy awarding official 
or other designee for each award that you currently have, unless Sec. 
1405.301 or the award document designates a central point for the 
receipt of the notices. When notice is made to a central point, it must 
include the identification number(s) of each affected award.

[[Page 311]]



Sec. 1405.301  [Reserved]



  Subpart D_Responsibilities of Office of National Drug Control Policy 
                           Awarding Officials



Sec. 1405.400  What are my responsibilities as a(n) Office of National
Drug Control Policy awarding official?

    As a(n) Office of National Drug Control Policy awarding official, 
you must obtain each recipient's agreement, as a condition of the award, 
to comply with the requirements in--
    (a) Subpart B of this part, if the recipient is not an individual; 
or
    (b) Subpart C of this part, if the recipient is an individual.



           Subpart E_Violations of this Part and Consequences



Sec. 1405.500  How are violations of this part determined for 
recipients other than individuals?

    A recipient other than an individual is in violation of the 
requirements of this part if the Director of National Drug Control 
Policy determines, in writing, that--
    (a) The recipient has violated the requirements of subpart B of this 
part; or
    (b) The number of convictions of the recipient's employees for 
violating criminal drug statutes in the workplace is large enough to 
indicate that the recipient has failed to make a good faith effort to 
provide a drug-free workplace.



Sec. 1405.505  How are violations of this part determined for 
recipients who are individuals?

    An individual recipient is in violation of the requirements of this 
part if the Director of National Drug Control Policy determines, in 
writing, that--
    (a) The recipient has violated the requirements of subpart C of this 
part; or
    (b) The recipient is convicted of a criminal drug offense resulting 
from a violation occurring during the conduct of any award activity.



Sec. 1405.510  What actions will the Federal Government take against
a recipient determined to have violated this part?

    If a recipient is determined to have violated this part, as 
described in Sec. 1405.500 or Sec. 1405.505, the Office of National 
Drug Control Policy may take one or more of the following actions--
    (a) Suspension of payments under the award;
    (b) Suspension or termination of the award; and
    (c) Suspension or debarment of the recipient under 21 CFR Part 1404, 
for a period not to exceed five years.



Sec. 1405.515  Are there any exceptions to those actions?

    The Director of National Drug Control Policy may waive with respect 
to a particular award, in writing, a suspension of payments under an 
award, suspension or termination of an award, or suspension or debarment 
of a recipient if the Director of National Drug Control Policy 
determines that such a waiver would be in the public interest. This 
exception authority cannot be delegated to any other official.



                          Subpart F_Definitions



Sec. 1405.605  Award.

    Award means an award of financial assistance by the Office of 
National Drug Control Policy or other Federal agency directly to a 
recipient.
    (a) The term award includes:
    (1) A Federal grant or cooperative agreement, in the form of money 
or property in lieu of money.
    (2) A block grant or a grant in an entitlement program, whether or 
not the grant is exempted from coverage under the Governmentwide rule 21 
CFR Part 1403 that implements OMB Circular A-102 (for availability, see 
5 CFR 1310.3) and specifies uniform administrative requirements.
    (b) The term award does not include:
    (1) Technical assistance that provides services instead of money.
    (2) Loans.
    (3) Loan guarantees.
    (4) Interest subsidies.
    (5) Insurance.
    (6) Direct appropriations.

[[Page 312]]

    (7) Veterans' benefits to individuals (i.e., any benefit to 
veterans, their families, or survivors by virtue of the service of a 
veteran in the Armed Forces of the United States).



Sec. 1405.610  Controlled substance.

    Controlled substance means a controlled substance in schedules I 
through V of the Controlled Substances Act (21 U.S.C. 812), and as 
further defined by regulation at 21 CFR 1308.11 through 1308.15.



Sec. 1405.615  Conviction.

    Conviction means a finding of guilt (including a plea of nolo 
contendere) or imposition of sentence, or both, by any judicial body 
charged with the responsibility to determine violations of the Federal 
or State criminal drug statutes.



Sec. 1405.620  Cooperative agreement.

    Cooperative agreement means an award of financial assistance that, 
consistent with 31 U.S.C. 6305, is used to enter into the same kind of 
relationship as a grant (see definition of grant in Sec. 1405.650), 
except that substantial involvement is expected between the Federal 
agency and the recipient when carrying out the activity contemplated by 
the award. The term does not include cooperative research and 
development agreements as defined in 15 U.S.C. 3710a.



Sec. 1405.625  Criminal drug statute.

    Criminal drug statute means a Federal or non-Federal criminal 
statute involving the manufacture, distribution, dispensing, use, or 
possession of any controlled substance.



Sec. 1405.630  Debarment.

    Debarment means an action taken by a Federal agency to prohibit a 
recipient from participating in Federal Government procurement contracts 
and covered nonprocurement transactions. A recipient so prohibited is 
debarred, in accordance with the Federal Acquisition Regulation for 
procurement contracts (48 CFR part 9, subpart 9.4) and the common rule, 
Government-wide Debarment and Suspension (Nonprocurement), that 
implements Executive Order 12549 and Executive Order 12689.



Sec. 1405.635  Drug-free workplace.

    Drug-free workplace means a site for the performance of work done in 
connection with a specific award at which employees of the recipient are 
prohibited from engaging in the unlawful manufacture, distribution, 
dispensing, possession, or use of a controlled substance.



Sec. 1405.640  Employee.

    (a) Employee means the employee of a recipient directly engaged in 
the performance of work under the award, including--
    (1) All direct charge employees;
    (2) All indirect charge employees, unless their impact or 
involvement in the performance of work under the award is insignificant 
to the performance of the award; and
    (3) Temporary personnel and consultants who are directly engaged in 
the performance of work under the award and who are on the recipient's 
payroll.
    (b) This definition does not include workers not on the payroll of 
the recipient (e.g., volunteers, even if used to meet a matching 
requirement; consultants or independent contractors not on the payroll; 
or employees of subrecipients or subcontractors in covered workplaces).



Sec. 1405.645  Federal agency or agency.

    Federal agency or agency means any United States executive 
department, military department, government corporation, government 
controlled corporation, any other establishment in the executive branch 
(including the Executive Office of the President), or any independent 
regulatory agency.



Sec. 1405.650  Grant.

    Grant means an award of financial assistance that, consistent with 
31 U.S.C. 6304, is used to enter into a relationship--
    (a) The principal purpose of which is to transfer a thing of value 
to the recipient to carry out a public purpose of support or stimulation 
authorized by a law of the United States, rather than to acquire 
property or services for the

[[Page 313]]

Federal Government's direct benefit or use; and
    (b) In which substantial involvement is not expected between the 
Federal agency and the recipient when carrying out the activity 
contemplated by the award.



Sec. 1405.655  Individual.

    Individual means a natural person.



Sec. 1405.660  Recipient.

    Recipient means any individual, corporation, partnership, 
association, unit of government (except a Federal agency) or legal 
entity, however organized, that receives an award directly from a 
Federal agency.



Sec. 1405.665  State.

    State means any of the States of the United States, the District of 
Columbia, the Commonwealth of Puerto Rico, or any territory or 
possession of the United States.



Sec. 1405.670  Suspension.

    Suspension means an action taken by a Federal agency that 
immediately prohibits a recipient from participating in Federal 
Government procurement contracts and covered nonprocurement transactions 
for a temporary period, pending completion of an investigation and any 
judicial or administrative proceedings that may ensue. A recipient so 
prohibited is suspended, in accordance with the Federal Acquisition 
Regulation for procurement contracts (48 CFR part 9, subpart 9.4) and 
the common rule, Government-wide Debarment and Suspension 
(Nonprocurement), that implements Executive Order 12549 and Executive 
Order 12689. Suspension of a recipient is a distinct and separate action 
from suspension of an award or suspension of payments under an award.

                       PARTS 1406	1499 [RESERVED]

[[Page 315]]



                              FINDING AIDS




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

  A list of CFR titles, subtitles, chapters, subchapters and parts and 
an alphabetical list of agencies publishing in the CFR are included in 
the CFR Index and Finding Aids volume to the Code of Federal Regulations 
which is published separately and revised annually.

  Table of CFR Titles and Chapters
  Alphabetical List of Agencies Appearing in the CFR
  List of CFR Sections Affected

[[Page 317]]



                    Table of CFR Titles and Chapters




                      (Revised as of April 1, 2014)

                      Title 1--General Provisions

         I  Administrative Committee of the Federal Register 
                (Parts 1--49)
        II  Office of the Federal Register (Parts 50--299)
       III  Administrative Conference of the United States (Parts 
                300--399)
        IV  Miscellaneous Agencies (Parts 400--500)

                    Title 2--Grants and Agreements

            Subtitle A--Office of Management and Budget Guidance 
                for Grants and Agreements
         I  Office of Management and Budget Governmentwide 
                Guidance for Grants and Agreements (Parts 2--199)
        II  Office of Management and Budget Guidance (Parts 200--
                299)
            Subtitle B--Federal Agency Regulations for Grants and 
                Agreements
       III  Department of Health and Human Services (Parts 300-- 
                399)
        IV  Department of Agriculture (Parts 400--499)
        VI  Department of State (Parts 600--699)
       VII  Agency for International Development (Parts 700--799)
      VIII  Department of Veterans Affairs (Parts 800--899)
        IX  Department of Energy (Parts 900--999)
        XI  Department of Defense (Parts 1100--1199)
       XII  Department of Transportation (Parts 1200--1299)
      XIII  Department of Commerce (Parts 1300--1399)
       XIV  Department of the Interior (Parts 1400--1499)
        XV  Environmental Protection Agency (Parts 1500--1599)
     XVIII  National Aeronautics and Space Administration (Parts 
                1800--1899)
        XX  United States Nuclear Regulatory Commission (Parts 
                2000--2099)
      XXII  Corporation for National and Community Service (Parts 
                2200--2299)
     XXIII  Social Security Administration (Parts 2300--2399)
      XXIV  Housing and Urban Development (Parts 2400--2499)
       XXV  National Science Foundation (Parts 2500--2599)
      XXVI  National Archives and Records Administration (Parts 
                2600--2699)
     XXVII  Small Business Administration (Parts 2700--2799)
    XXVIII  Department of Justice (Parts 2800--2899)

[[Page 318]]

       XXX  Department of Homeland Security (Parts 3000--3099)
      XXXI  Institute of Museum and Library Services (Parts 3100--
                3199)
     XXXII  National Endowment for the Arts (Parts 3200--3299)
    XXXIII  National Endowment for the Humanities (Parts 3300--
                3399)
     XXXIV  Department of Education (Parts 3400--3499)
      XXXV  Export-Import Bank of the United States (Parts 3500--
                3599)
    XXXVII  Peace Corps (Parts 3700--3799)
     LVIII  Election Assistance Commission (Parts 5800--5899)

                        Title 3--The President

         I  Executive Office of the President (Parts 100--199)

                           Title 4--Accounts

         I  Government Accountability Office (Parts 1--199)
        II  Recovery Accountability and Transparency Board (Parts 
                200--299)

                   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 (Parts 2100--2199)
       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 (Parts 3200--
                3299)
     XXIII  Department of Energy (Parts 3300--3399)
      XXIV  Federal Energy Regulatory Commission (Parts 3400--
                3499)
       XXV  Department of the Interior (Parts 3500--3599)
      XXVI  Department of Defense (Parts 3600-- 3699)
    XXVIII  Department of Justice (Parts 3800--3899)
      XXIX  Federal Communications Commission (Parts 3900--3999)
       XXX  Farm Credit System Insurance Corporation (Parts 4000--
                4099)
      XXXI  Farm Credit Administration (Parts 4100--4199)

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    XXXIII  Overseas Private Investment Corporation (Parts 4300--
                4399)
     XXXIV  Securities and Exchange Commission (Parts 4400--4499)
      XXXV  Office of Personnel Management (Parts 4500--4599)
    XXXVII  Federal Election Commission (Parts 4700--4799)
        XL  Interstate Commerce Commission (Parts 5000--5099)
       XLI  Commodity Futures Trading Commission (Parts 5100--
                5199)
      XLII  Department of Labor (Parts 5200--5299)
     XLIII  National Science Foundation (Parts 5300--5399)
       XLV  Department of Health and Human Services (Parts 5500--
                5599)
      XLVI  Postal Rate Commission (Parts 5600--5699)
     XLVII  Federal Trade Commission (Parts 5700--5799)
    XLVIII  Nuclear Regulatory Commission (Parts 5800--5899)
      XLIX  Federal Labor Relations Authority (Parts 5900--5999)
         L  Department of Transportation (Parts 6000--6099)
       LII  Export-Import Bank of the United States (Parts 6200--
                6299)
      LIII  Department of Education (Parts 6300--6399)
       LIV  Environmental Protection Agency (Parts 6400--6499)
        LV  National Endowment for the Arts (Parts 6500--6599)
       LVI  National Endowment for the Humanities (Parts 6600--
                6699)
      LVII  General Services Administration (Parts 6700--6799)
     LVIII  Board of Governors of the Federal Reserve System 
                (Parts 6800--6899)
       LIX  National Aeronautics and Space Administration (Parts 
                6900--6999)
        LX  United States Postal Service (Parts 7000--7099)
       LXI  National Labor Relations Board (Parts 7100--7199)
      LXII  Equal Employment Opportunity Commission (Parts 7200--
                7299)
     LXIII  Inter-American Foundation (Parts 7300--7399)
      LXIV  Merit Systems Protection Board (Parts 7400--7499)
       LXV  Department of Housing and Urban Development (Parts 
                7500--7599)
      LXVI  National Archives and Records Administration (Parts 
                7600--7699)
     LXVII  Institute of Museum and Library Services (Parts 7700--
                7799)
    LXVIII  Commission on Civil Rights (Parts 7800--7899)
      LXIX  Tennessee Valley Authority (Parts 7900--7999)
       LXX  Court Services and Offender Supervision Agency for the 
                District of Columbia (Parts 8000--8099)
      LXXI  Consumer Product Safety Commission (Parts 8100--8199)
    LXXIII  Department of Agriculture (Parts 8300--8399)
     LXXIV  Federal Mine Safety and Health Review Commission 
                (Parts 8400--8499)
     LXXVI  Federal Retirement Thrift Investment Board (Parts 
                8600--8699)
    LXXVII  Office of Management and Budget (Parts 8700--8799)
      LXXX  Federal Housing Finance Agency (Parts 9000--9099)
   LXXXIII  Special Inspector General for Afghanistan 
                Reconstruction (Parts 9300--9399)

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    LXXXIV  Bureau of Consumer Financial Protection (Parts 9400--
                9499)
    LXXXVI  National Credit Union Administration (Parts 9600--
                9699)
     XCVII  Department of Homeland Security Human Resources 
                Management System (Department of Homeland 
                Security--Office of Personnel Management) (Parts 
                9700--9799)
     XCVII  Council of the Inspectors General on Integrity and 
                Efficiency (Parts 9800--9899)

                      Title 6--Domestic Security

         I  Department of Homeland Security, Office of the 
                Secretary (Parts 1--99)
         X  Privacy and Civil Liberties Oversight Board (Parts 
                1000--1099)

                         Title 7--Agriculture

            Subtitle A--Office of the Secretary of Agriculture 
                (Parts 0--26)
            Subtitle B--Regulations of the Department of 
                Agriculture
         I  Agricultural Marketing Service (Standards, 
                Inspections, Marketing Practices), Department of 
                Agriculture (Parts 27--209)
        II  Food and Nutrition Service, Department of Agriculture 
                (Parts 210--299)
       III  Animal and Plant Health Inspection Service, Department 
                of Agriculture (Parts 300--399)
        IV  Federal Crop Insurance Corporation, Department of 
                Agriculture (Parts 400--499)
         V  Agricultural Research Service, Department of 
                Agriculture (Parts 500--599)
        VI  Natural Resources Conservation Service, Department of 
                Agriculture (Parts 600--699)
       VII  Farm Service Agency, Department of Agriculture (Parts 
                700--799)
      VIII  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)

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      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)
       XXV  Office of Advocacy and Outreach, Department of 
                Agriculture (Parts 2500--2599)
      XXVI  Office of Inspector General, Department of Agriculture 
                (Parts 2600--2699)
     XXVII  Office of Information Resources Management, Department 
                of Agriculture (Parts 2700--2799)
    XXVIII  Office of Operations, Department of Agriculture (Parts 
                2800--2899)
      XXIX  Office of Energy Policy and New Uses, Department of 
                Agriculture (Parts 2900--2999)
       XXX  Office of the Chief Financial Officer, Department of 
                Agriculture (Parts 3000--3099)
      XXXI  Office of Environmental Quality, Department of 
                Agriculture (Parts 3100--3199)
     XXXII  Office of Procurement and Property Management, 
                Department of Agriculture (Parts 3200--3299)
    XXXIII  Office of Transportation, Department of Agriculture 
                (Parts 3300--3399)
     XXXIV  National Institute of Food and Agriculture (Parts 
                3400--3499)
      XXXV  Rural Housing Service, Department of Agriculture 
                (Parts 3500--3599)
     XXXVI  National Agricultural Statistics Service, Department 
                of Agriculture (Parts 3600--3699)
    XXXVII  Economic Research Service, Department of Agriculture 
                (Parts 3700--3799)
   XXXVIII  World Agricultural Outlook Board, Department of 
                Agriculture (Parts 3800--3899)
       XLI  [Reserved]
      XLII  Rural Business-Cooperative Service and Rural Utilities 
                Service, Department of Agriculture (Parts 4200--
                4299)

                    Title 8--Aliens and Nationality

         I  Department of Homeland Security (Immigration and 
                Naturalization) (Parts 1--499)
         V  Executive Office for Immigration Review, Department of 
                Justice (Parts 1000--1399)

                 Title 9--Animals and Animal Products

         I  Animal and Plant Health Inspection Service, Department 
                of Agriculture (Parts 1--199)

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        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)
      XIII  Nuclear Waste Technical Review Board (Parts 1300--
                1399)
      XVII  Defense Nuclear Facilities Safety Board (Parts 1700--
                1799)
     XVIII  Northeast Interstate Low-Level Radioactive Waste 
                Commission (Parts 1800--1899)

                      Title 11--Federal Elections

         I  Federal Election Commission (Parts 1--9099)
        II  Election Assistance Commission (Parts 9400--9499)

                      Title 12--Banks and Banking

         I  Comptroller of the Currency, Department of the 
                Treasury (Parts 1--199)
        II  Federal Reserve System (Parts 200--299)
       III  Federal Deposit Insurance Corporation (Parts 300--399)
        IV  Export-Import Bank of the United States (Parts 400--
                499)
         V  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)
         X  Bureau of Consumer Financial Protection (Parts 1000--
                1099)
        XI  Federal Financial Institutions Examination Council 
                (Parts 1100--1199)
       XII  Federal Housing Finance Agency (Parts 1200--1299)
      XIII  Financial Stability Oversight Council (Parts 1300--
                1399)
       XIV  Farm Credit System Insurance Corporation (Parts 1400--
                1499)
        XV  Department of the Treasury (Parts 1500--1599)
       XVI  Office of Financial Research (Parts 1600--1699)
      XVII  Office of Federal Housing Enterprise Oversight, 
                Department of Housing and Urban Development (Parts 
                1700--1799)
     XVIII  Community Development Financial Institutions Fund, 
                Department of the Treasury (Parts 1800--1899)

[[Page 323]]

               Title 13--Business Credit and Assistance

         I  Small Business Administration (Parts 1--199)
       III  Economic Development Administration, Department of 
                Commerce (Parts 300--399)
        IV  Emergency Steel Guarantee Loan Board (Parts 400--499)
         V  Emergency Oil and Gas Guaranteed Loan Board (Parts 
                500--599)

                    Title 14--Aeronautics and Space

         I  Federal Aviation Administration, Department of 
                Transportation (Parts 1--199)
        II  Office of the Secretary, Department of Transportation 
                (Aviation Proceedings) (Parts 200--399)
       III  Commercial Space Transportation, Federal Aviation 
                Administration, Department of Transportation 
                (Parts 400--1199)
         V  National Aeronautics and Space Administration (Parts 
                1200--1299)
        VI  Air Transportation System Stabilization (Parts 1300--
                1399)

                 Title 15--Commerce and Foreign Trade

            Subtitle A--Office of the Secretary of Commerce (Parts 
                0--29)
            Subtitle B--Regulations Relating to Commerce and 
                Foreign Trade
         I  Bureau of the Census, Department of Commerce (Parts 
                30--199)
        II  National Institute of Standards and Technology, 
                Department of Commerce (Parts 200--299)
       III  International Trade Administration, Department of 
                Commerce (Parts 300--399)
        IV  Foreign-Trade Zones Board, Department of Commerce 
                (Parts 400--499)
       VII  Bureau of Industry and Security, Department of 
                Commerce (Parts 700--799)
      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)

[[Page 324]]

                    Title 16--Commercial Practices

         I  Federal Trade Commission (Parts 0--999)
        II  Consumer Product Safety Commission (Parts 1000--1799)

             Title 17--Commodity and Securities Exchanges

         I  Commodity Futures Trading Commission (Parts 1--199)
        II  Securities and Exchange Commission (Parts 200--399)
        IV  Department of the Treasury (Parts 400--499)

          Title 18--Conservation of Power and Water Resources

         I  Federal Energy Regulatory Commission, Department of 
                Energy (Parts 1--399)
       III  Delaware River Basin Commission (Parts 400--499)
        VI  Water Resources Council (Parts 700--799)
      VIII  Susquehanna River Basin Commission (Parts 800--899)
      XIII  Tennessee Valley Authority (Parts 1300--1399)

                       Title 19--Customs Duties

         I  U.S. Customs and Border Protection, Department of 
                Homeland Security; Department of the Treasury 
                (Parts 0--199)
        II  United States International Trade Commission (Parts 
                200--299)
       III  International Trade Administration, Department of 
                Commerce (Parts 300--399)
        IV  U.S. Immigration and Customs Enforcement, Department 
                of Homeland Security (Parts 400--599)

                     Title 20--Employees' Benefits

         I  Office of Workers' Compensation Programs, Department 
                of Labor (Parts 1--199)
        II  Railroad Retirement Board (Parts 200--399)
       III  Social Security Administration (Parts 400--499)
        IV  Employees' Compensation Appeals Board, Department of 
                Labor (Parts 500--599)
         V  Employment and Training Administration, Department of 
                Labor (Parts 600--699)
        VI  Office of Workers' Compensation Programs, Department 
                of Labor (Parts 700--799)
       VII  Benefits Review Board, Department of Labor (Parts 
                800--899)
      VIII  Joint Board for the Enrollment of Actuaries (Parts 
                900--999)
        IX  Office of the Assistant Secretary for Veterans' 
                Employment and Training Service, Department of 
                Labor (Parts 1000--1099)

[[Page 325]]

                       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)
      XIII  Millennium Challenge Corporation (Parts 1300--1399)
       XIV  Foreign Service Labor Relations Board; Federal Labor 
                Relations Authority; General Counsel of the 
                Federal Labor Relations Authority; and the Foreign 
                Service Impasse Disputes Panel (Parts 1400--1499)
        XV  African Development Foundation (Parts 1500--1599)
       XVI  Japan-United States Friendship Commission (Parts 
                1600--1699)
      XVII  United States Institute of Peace (Parts 1700--1799)

                          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)

[[Page 326]]

        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)
       XII  Office of Inspector General, Department of Housing and 
                Urban Development (Parts 2000--2099)
        XV  Emergency Mortgage Insurance and Loan Programs, 
                Department of Housing and Urban Development (Parts 
                2700--2799)
        XX  Office of Assistant Secretary for Housing--Federal 
                Housing Commissioner, Department of Housing and 
                Urban Development (Parts 3200--3899)
      XXIV  Board of Directors of the HOPE for Homeowners Program 
                (Parts 4000--4099)
       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)

[[Page 327]]

        VI  Office of the Assistant Secretary-Indian Affairs, 
                Department of the Interior (Parts 1000--1199)
       VII  Office of the Special Trustee for American Indians, 
                Department of the Interior (Parts 1200--1299)

                      Title 26--Internal Revenue

         I  Internal Revenue Service, Department of the Treasury 
                (Parts 1--End)

           Title 27--Alcohol, Tobacco Products and Firearms

         I  Alcohol and Tobacco Tax and Trade Bureau, Department 
                of the Treasury (Parts 1--399)
        II  Bureau of Alcohol, Tobacco, Firearms, and Explosives, 
                Department of Justice (Parts 400--699)

                   Title 28--Judicial Administration

         I  Department of Justice (Parts 0--299)
       III  Federal Prison Industries, Inc., Department of Justice 
                (Parts 300--399)
         V  Bureau of Prisons, Department of Justice (Parts 500--
                599)
        VI  Offices of Independent Counsel, Department of Justice 
                (Parts 600--699)
       VII  Office of Independent Counsel (Parts 700--799)
      VIII  Court Services and Offender Supervision Agency for the 
                District of Columbia (Parts 800--899)
        IX  National Crime Prevention and Privacy Compact Council 
                (Parts 900--999)
        XI  Department of Justice and Department of State (Parts 
                1100--1199)

                            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)

[[Page 328]]

      XVII  Occupational Safety and Health Administration, 
                Department of Labor (Parts 1900--1999)
        XX  Occupational Safety and Health Review Commission 
                (Parts 2200--2499)
       XXV  Employee Benefits Security Administration, Department 
                of Labor (Parts 2500--2599)
     XXVII  Federal Mine Safety and Health Review Commission 
                (Parts 2700--2799)
        XL  Pension Benefit Guaranty Corporation (Parts 4000--
                4999)

                      Title 30--Mineral Resources

         I  Mine Safety and Health Administration, Department of 
                Labor (Parts 1--199)
        II  Bureau of Safety and Environmental Enforcement, 
                Department of the Interior (Parts 200--299)
        IV  Geological Survey, Department of the Interior (Parts 
                400--499)
         V  Bureau of Ocean Energy Management, Department of the 
                Interior (Parts 500--599)
       VII  Office of Surface Mining Reclamation and Enforcement, 
                Department of the Interior (Parts 700--999)
       XII  Office of Natural Resources Revenue, Department of the 
                Interior (Parts 1200--1299)

                 Title 31--Money and Finance: Treasury

            Subtitle A--Office of the Secretary of the Treasury 
                (Parts 0--50)
            Subtitle B--Regulations Relating to Money and Finance
         I  Monetary Offices, Department of the Treasury (Parts 
                51--199)
        II  Fiscal Service, Department of the Treasury (Parts 
                200--399)
        IV  Secret Service, Department of the Treasury (Parts 
                400--499)
         V  Office of Foreign Assets Control, Department of the 
                Treasury (Parts 500--599)
        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)
         X  Financial Crimes Enforcement Network, Department of 
                the Treasury (Parts 1000--1099)

                      Title 32--National Defense

            Subtitle A--Department of Defense
         I  Office of the Secretary of Defense (Parts 1--399)

[[Page 329]]

         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)
      XVII  Office of the Director of National Intelligence (Parts 
                1700--1799)
     XVIII  National Counterintelligence Center (Parts 1800--1899)
       XIX  Central Intelligence Agency (Parts 1900--1999)
        XX  Information Security Oversight Office, National 
                Archives and Records Administration (Parts 2000--
                2099)
       XXI  National Security Council (Parts 2100--2199)
      XXIV  Office of Science and Technology Policy (Parts 2400--
                2499)
     XXVII  Office for Micronesian Status Negotiations (Parts 
                2700--2799)
    XXVIII  Office of the Vice President of the United States 
                (Parts 2800--2899)

               Title 33--Navigation and Navigable Waters

         I  Coast Guard, Department of Homeland Security (Parts 
                1--199)
        II  Corps of Engineers, Department of the Army (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)
        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)
       VII  Office of Educational Research and Improvement, 
                Department of Education (Parts 700--799)[Reserved]
            Subtitle C--Regulations Relating to Education
        XI  National Institute for Literacy (Parts 1100--1199)
       XII  National Council on Disability (Parts 1200--1299)

[[Page 330]]

                          Title 35 [Reserved]

             Title 36--Parks, Forests, and Public Property

         I  National Park Service, Department of the Interior 
                (Parts 1--199)
        II  Forest Service, Department of Agriculture (Parts 200--
                299)
       III  Corps of Engineers, Department of the Army (Parts 
                300--399)
        IV  American Battle Monuments Commission (Parts 400--499)
         V  Smithsonian Institution (Parts 500--599)
        VI  [Reserved]
       VII  Library of Congress (Parts 700--799)
      VIII  Advisory Council on Historic Preservation (Parts 800--
                899)
        IX  Pennsylvania Avenue Development Corporation (Parts 
                900--999)
         X  Presidio Trust (Parts 1000--1099)
        XI  Architectural and Transportation Barriers Compliance 
                Board (Parts 1100--1199)
       XII  National Archives and Records Administration (Parts 
                1200--1299)
        XV  Oklahoma City National Memorial Trust (Parts 1500--
                1599)
       XVI  Morris K. Udall Scholarship and Excellence in National 
                Environmental Policy Foundation (Parts 1600--1699)

             Title 37--Patents, Trademarks, and Copyrights

         I  United States Patent and Trademark Office, Department 
                of Commerce (Parts 1--199)
        II  U.S. Copyright Office, Library of Congress (Parts 
                200--299)
       III  Copyright Royalty Board, Library of Congress (Parts 
                300--399)
        IV  Assistant Secretary for Technology Policy, Department 
                of Commerce (Parts 400--599)

           Title 38--Pensions, Bonuses, and Veterans' Relief

         I  Department of Veterans Affairs (Parts 0--199)
        II  Armed Forces Retirement Home (Parts 200--299)

                       Title 39--Postal Service

         I  United States Postal Service (Parts 1--999)
       III  Postal Regulatory Commission (Parts 3000--3099)

                  Title 40--Protection of Environment

         I  Environmental Protection Agency (Parts 1--1099)
        IV  Environmental Protection Agency and Department of 
                Justice (Parts 1400--1499)
         V  Council on Environmental Quality (Parts 1500--1599)
        VI  Chemical Safety and Hazard Investigation Board (Parts 
                1600--1699)

[[Page 331]]

       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 A--Federal Procurement Regulations System 
                [Note]
            Subtitle B--Other Provisions Relating to Public 
                Contracts
        50  Public Contracts, Department of Labor (Parts 50-1--50-
                999)
        51  Committee for Purchase From People Who Are Blind or 
                Severely Disabled (Parts 51-1--51-99)
        60  Office of Federal Contract Compliance Programs, Equal 
                Employment Opportunity, Department of Labor (Parts 
                60-1--60-999)
        61  Office of the Assistant Secretary for Veterans' 
                Employment and Training Service, Department of 
                Labor (Parts 61-1--61-999)
   62--100  [Reserved]
            Subtitle C--Federal Property Management Regulations 
                System
       101  Federal Property Management Regulations (Parts 101-1--
                101-99)
       102  Federal Management Regulation (Parts 102-1--102-299)
  103--104  [Reserved]
       105  General Services Administration (Parts 105-1--105-999)
       109  Department of Energy Property Management Regulations 
                (Parts 109-1--109-99)
       114  Department of the Interior (Parts 114-1--114-99)
       115  Environmental Protection Agency (Parts 115-1--115-99)
       128  Department of Justice (Parts 128-1--128-99)
  129--200  [Reserved]
            Subtitle D--Other Provisions Relating to Property 
                Management [Reserved]
            Subtitle E--Federal Information Resources Management 
                Regulations System [Reserved]
            Subtitle F--Federal Travel Regulation System
       300  General (Parts 300-1--300-99)
       301  Temporary Duty (TDY) Travel Allowances (Parts 301-1--
                301-99)
       302  Relocation Allowances (Parts 302-1--302-99)
       303  Payment of Expenses Connected with the Death of 
                Certain Employees (Part 303-1--303-99)
       304  Payment of Travel Expenses from a Non-Federal Source 
                (Parts 304-1--304-99)

                        Title 42--Public Health

         I  Public Health Service, Department of Health and Human 
                Services (Parts 1--199)
        IV  Centers for Medicare & Medicaid Services, Department 
                of Health and Human Services (Parts 400--599)

[[Page 332]]

         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 400--999)
        II  Bureau of Land Management, Department of the Interior 
                (Parts 1000--9999)
       III  Utah Reclamation Mitigation and Conservation 
                Commission (Parts 10000--10099)

             Title 44--Emergency Management and Assistance

         I  Federal Emergency Management Agency, Department of 
                Homeland Security (Parts 0--399)
        IV  Department of Commerce and Department of 
                Transportation (Parts 400--499)

                       Title 45--Public Welfare

            Subtitle A--Department of Health and Human Services 
                (Parts 1--199)
            Subtitle B--Regulations Relating to Public Welfare
        II  Office of Family Assistance (Assistance Programs), 
                Administration for Children and Families, 
                Department of Health and Human Services (Parts 
                200--299)
       III  Office of Child Support Enforcement (Child Support 
                Enforcement Program), Administration for Children 
                and Families, Department of Health and Human 
                Services (Parts 300--399)
        IV  Office of Refugee Resettlement, Administration for 
                Children and Families, Department of Health and 
                Human Services (Parts 400--499)
         V  Foreign Claims Settlement Commission of the United 
                States, Department of Justice (Parts 500--599)
        VI  National Science Foundation (Parts 600--699)
       VII  Commission on Civil Rights (Parts 700--799)
      VIII  Office of Personnel Management (Parts 800--899)
         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)

[[Page 333]]

       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 Homeland Security (Parts 
                1--199)
        II  Maritime Administration, Department of Transportation 
                (Parts 200--399)
       III  Coast Guard (Great Lakes Pilotage), Department of 
                Homeland Security (Parts 400--499)
        IV  Federal Maritime Commission (Parts 500--599)

                      Title 47--Telecommunication

         I  Federal Communications Commission (Parts 0--199)
        II  Office of Science and Technology Policy and National 
                Security Council (Parts 200--299)
       III  National Telecommunications and Information 
                Administration, Department of Commerce (Parts 
                300--399)
        IV  National Telecommunications and Information 
                Administration, Department of Commerce, and 
                National Highway Traffic Safety Administration, 
                Department of Transportation (Parts 400--499)

           Title 48--Federal Acquisition Regulations System

         1  Federal Acquisition Regulation (Parts 1--99)
         2  Defense Acquisition Regulations System, Department of 
                Defense (Parts 200--299)
         3  Health and Human Services (Parts 300--399)
         4  Department of Agriculture (Parts 400--499)
         5  General Services Administration (Parts 500--599)
         6  Department of State (Parts 600--699)
         7  Agency for International Development (Parts 700--799)
         8  Department of Veterans Affairs (Parts 800--899)
         9  Department of Energy (Parts 900--999)
        10  Department of the Treasury (Parts 1000--1099)
        12  Department of Transportation (Parts 1200--1299)
        13  Department of Commerce (Parts 1300--1399)
        14  Department of the Interior (Parts 1400--1499)

[[Page 334]]

        15  Environmental Protection Agency (Parts 1500--1599)
        16  Office of Personnel Management, Federal Employees 
                Health Benefits Acquisition Regulation (Parts 
                1600--1699)
        17  Office of Personnel Management (Parts 1700--1799)
        18  National Aeronautics and Space Administration (Parts 
                1800--1899)
        19  Broadcasting Board of Governors (Parts 1900--1999)
        20  Nuclear Regulatory Commission (Parts 2000--2099)
        21  Office of Personnel Management, Federal Employees 
                Group Life Insurance Federal Acquisition 
                Regulation (Parts 2100--2199)
        23  Social Security Administration (Parts 2300--2399)
        24  Department of Housing and Urban Development (Parts 
                2400--2499)
        25  National Science Foundation (Parts 2500--2599)
        28  Department of Justice (Parts 2800--2899)
        29  Department of Labor (Parts 2900--2999)
        30  Department of Homeland Security, Homeland Security 
                Acquisition Regulation (HSAR) (Parts 3000--3099)
        34  Department of Education Acquisition Regulation (Parts 
                3400--3499)
        51  Department of the Army Acquisition Regulations (Parts 
                5100--5199)
        52  Department of the Navy Acquisition Regulations (Parts 
                5200--5299)
        53  Department of the Air Force Federal Acquisition 
                Regulation Supplement (Parts 5300--5399) 
                [Reserved]
        54  Defense Logistics Agency, Department of Defense (Parts 
                5400--5499)
        57  African Development Foundation (Parts 5700--5799)
        61  Civilian Board of Contract Appeals, General Services 
                Administration (Parts 6100--6199)
        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)

                       Title 49--Transportation

            Subtitle A--Office of the Secretary of Transportation 
                (Parts 1--99)
            Subtitle B--Other Regulations Relating to 
                Transportation
         I  Pipeline and Hazardous Materials Safety 
                Administration, Department of Transportation 
                (Parts 100--199)
        II  Federal Railroad Administration, Department of 
                Transportation (Parts 200--299)
       III  Federal Motor Carrier Safety Administration, 
                Department of Transportation (Parts 300--399)
        IV  Coast Guard, Department of Homeland Security (Parts 
                400--499)

[[Page 335]]

         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  Research and Innovative Technology Administration, 
                Department of Transportation (Parts 1400--1499) 
                [Reserved]
       XII  Transportation Security Administration, Department of 
                Homeland Security (Parts 1500--1699)

                   Title 50--Wildlife and Fisheries

         I  United States Fish and Wildlife Service, Department of 
                the Interior (Parts 1--199)
        II  National Marine Fisheries Service, National Oceanic 
                and Atmospheric Administration, Department of 
                Commerce (Parts 200--299)
       III  International Fishing and Related Activities (Parts 
                300--399)
        IV  Joint Regulations (United States Fish and Wildlife 
                Service, Department of the Interior and National 
                Marine Fisheries Service, National Oceanic and 
                Atmospheric Administration, Department of 
                Commerce); Endangered Species Committee 
                Regulations (Parts 400--499)
         V  Marine Mammal Commission (Parts 500--599)
        VI  Fishery Conservation and Management, National Oceanic 
                and Atmospheric Administration, Department of 
                Commerce (Parts 600--699)

[[Page 337]]





           Alphabetical List of Agencies Appearing in the CFR




                      (Revised as of April 1, 2014)

                                                  CFR Title, Subtitle or 
                     Agency                               Chapter

Administrative Committee of the Federal Register  1, I
Administrative Conference of the United States    1, III
Advisory Council on Historic Preservation         36, VIII
Advocacy and Outreach, Office of                  7, XXV
Afghanistan Reconstruction, Special Inspector     22, LXXXIII
     General for
African Development Foundation                    22, XV
  Federal Acquisition Regulation                  48, 57
Agency for International Development              2, VII; 22, II
  Federal Acquisition Regulation                  48, 7
Agricultural Marketing Service                    7, I, IX, X, XI
Agricultural Research Service                     7, V
Agriculture Department                            2, IV; 5, LXXIII
  Advocacy and Outreach, Office of                7, XXV
  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
  Economic Research Service                       7, XXXVII
  Energy Policy and New Uses, Office of           2, IX; 7, XXIX
  Environmental Quality, Office of                7, XXXI
  Farm Service Agency                             7, VII, XVIII
  Federal Acquisition Regulation                  48, 4
  Federal Crop Insurance Corporation              7, IV
  Food and Nutrition Service                      7, II
  Food Safety and Inspection Service              9, III
  Foreign Agricultural Service                    7, XV
  Forest Service                                  36, II
  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
  National Institute of Food and Agriculture      7, XXXIV
  Natural Resources Conservation Service          7, VI
  Operations, Office of                           7, XXVIII
  Procurement and Property Management, Office of  7, XXXII
  Rural Business-Cooperative Service              7, XVIII, XLII, L
  Rural Development Administration                7, XLII
  Rural Housing Service                           7, XVIII, XXXV, L
  Rural Telephone Bank                            7, XVI
  Rural Utilities Service                         7, XVII, XVIII, XLII, L
  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

[[Page 338]]

Animal and Plant Health Inspection Service        7, III; 9, I
Appalachian Regional Commission                   5, IX
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
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
Bureau of Ocean Energy Management, Regulation,    30, II
     and Enforcement
Census Bureau                                     15, I
Centers for Medicare & Medicaid Services          42, IV
Central Intelligence Agency                       32, XIX
Chemical Safety and Hazardous Investigation       40, VI
     Board
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                       5, LXVIII; 45, VII
Civil Rights, Office for                          34, I
Council of the Inspectors General on Integrity    5, XCVIII
     and Efficiency
Court Services and Offender Supervision Agency    5, LXX
     for the District of Columbia
Coast Guard                                       33, I; 46, I; 49, IV
Coast Guard (Great Lakes Pilotage)                46, III
Commerce Department                               2, XIII; 44, IV; 50, VI
  Census Bureau                                   15, I
  Economic Analysis, Bureau of                    15, VIII
  Economic Development Administration             13, III
  Emergency Management and Assistance             44, IV
  Federal Acquisition Regulation                  48, 13
  Foreign-Trade Zones Board                       15, IV
  Industry and Security, Bureau of                15, VII
  International Trade Administration              15, III; 19, III
  National Institute of Standards and Technology  15, II
  National Marine Fisheries Service               50, II, IV
  National Oceanic and Atmospheric                15, IX; 50, II, III, IV, 
       Administration                             VI
  National Telecommunications and Information     15, XXIII; 47, III, IV
       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 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 Financial Protection Bureau              5, LXXXIV; 12, X
Consumer Product Safety Commission                5, LXXI; 16, II
Copyright Royalty Board                           37, III
Corporation for National and Community Service    2, XXII; 45, XII, XXV
Cost Accounting Standards Board                   48, 99
Council on Environmental Quality                  40, V
Court Services and Offender Supervision Agency    5, LXX; 28, VIII
     for the District of Columbia
Customs and Border Protection                     19, I

[[Page 339]]

Defense Contract Audit Agency                     32, I
Defense Department                                2, XI; 5, XXVI; 32, 
                                                  Subtitle A; 40, VII
  Advanced Research Projects Agency               32, I
  Air Force Department                            32, VII
  Army Department                                 32, V; 33, II; 36, III, 
                                                  48, 51
  Defense Acquisition Regulations System          48, 2
  Defense Intelligence Agency                     32, I
  Defense Logistics Agency                        32, I, XII; 48, 54
  Engineers, Corps of                             33, II; 36, III
  National Imagery and Mapping Agency             32, I
  Navy Department                                 32, VI; 48, 52
  Secretary of Defense, Office of                 2, XI; 32, I
Defense Contract Audit Agency                     32, I
Defense Intelligence Agency                       32, I
Defense Logistics Agency                          32, XII; 48, 54
Defense Nuclear Facilities Safety Board           10, XVII
Delaware River Basin Commission                   18, III
District of Columbia, Court Services and          5, LXX; 28, VIII
     Offender Supervision Agency for the
Drug Enforcement Administration                   21, II
East-West Foreign Trade Board                     15, XIII
Economic Analysis, Bureau of                      15, VIII
Economic Development Administration               13, III
Economic Research Service                         7, XXXVII
Education, Department of                          2, XXXIV; 5, LIII
  Bilingual Education and Minority Languages      34, V
       Affairs, Office of
  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
Election Assistance Commission                    2, LVIII; 11, II
Elementary and Secondary Education, Office of     34, II
Emergency Oil and Gas Guaranteed Loan Board       13, V
Emergency Steel Guarantee Loan Board              13, IV
Employee Benefits Security Administration         29, XXV
Employees' Compensation Appeals Board             20, IV
Employees Loyalty Board                           5, V
Employment and Training Administration            20, V
Employment Standards Administration               20, VI
Endangered Species Committee                      50, IV
Energy, Department of                             2, IX; 5, XXIII; 10, II, 
                                                  III, X
  Federal Acquisition Regulation                  48, 9
  Federal Energy Regulatory Commission            5, XXIV; 18, I
  Property Management Regulations                 41, 109
Energy, Office of                                 7, XXIX
Engineers, Corps of                               33, II; 36, III
Engraving and Printing, Bureau of                 31, VI
Environmental Protection Agency                   2, XV; 5, LIV; 40, I, IV, 
                                                  VII
  Federal Acquisition Regulation                  48, 15
  Property Management Regulations                 41, 115
Environmental Quality, Office of                  7, XXXI
Equal Employment Opportunity Commission           5, LXII; 29, XIV
Equal Opportunity, Office of Assistant Secretary  24, I
     for
Executive Office of the President                 3, I
  Administration, Office of                       5, XV
  Environmental Quality, Council on               40, V
  Management and Budget, Office of                2, Subtitle A; 5, III, 
                                                  LXXVII; 14, VI; 48, 99

[[Page 340]]

  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
Export-Import Bank of the United States           2, XXXV; 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                       5, XXXVII; 11, I
Federal Emergency Management Agency               44, I
Federal Employees Group Life Insurance Federal    48, 21
     Acquisition Regulation
Federal Employees Health Benefits Acquisition     48, 16
     Regulation
Federal Energy Regulatory Commission              5, XXIV; 18, I
Federal Financial Institutions Examination        12, XI
     Council
Federal Financing Bank                            12, VIII
Federal Highway Administration                    23, I, II
Federal Home Loan Mortgage Corporation            1, IV
Federal Housing Enterprise Oversight Office       12, XVII
Federal Housing Finance Agency                    5, LXXX; 12, XII
Federal Housing Finance Board                     12, IX
Federal Labor Relations Authority                 5, XIV, XLIX; 22, XIV
Federal Law Enforcement Training Center           31, VII
Federal Management Regulation                     41, 102
Federal Maritime Commission                       46, IV
Federal Mediation and Conciliation Service        29, XII
Federal Mine Safety and Health Review Commission  5, LXXIV; 29, XXVII
Federal Motor Carrier Safety Administration       49, III
Federal Prison Industries, Inc.                   28, III
Federal Procurement Policy Office                 48, 99
Federal Property Management Regulations           41, 101
Federal Railroad Administration                   49, II
Federal Register, Administrative Committee of     1, I
Federal Register, Office of                       1, II
Federal Reserve System                            12, II
  Board of Governors                              5, LVIII
Federal Retirement Thrift Investment Board        5, VI, LXXVI
Federal Service Impasses Panel                    5, XIV
Federal Trade Commission                          5, XLVII; 16, I
Federal Transit Administration                    49, VI
Federal Travel Regulation System                  41, Subtitle F
Financial Crimes Enforcement Network              31, X
Financial Research Office                         12, XVI
Financial Stability Oversight Council             12, XIII
Fine Arts, Commission on                          45, XXI
Fiscal Service                                    31, II
Fish and Wildlife Service, United States          50, I, IV
Food and Drug Administration                      21, I
Food and Nutrition Service                        7, II
Food Safety and Inspection Service                9, III
Foreign Agricultural Service                      7, XV
Foreign Assets Control, Office of                 31, V
Foreign Claims Settlement Commission of the       45, V
     United States
Foreign Service Grievance Board                   22, IX
Foreign Service Impasse Disputes Panel            22, XIV
Foreign Service Labor Relations Board             22, XIV
Foreign-Trade Zones Board                         15, IV

[[Page 341]]

Forest Service                                    36, II
General Services Administration                   5, LVII; 41, 105
  Contract Appeals, Board of                      48, 61
  Federal Acquisition Regulation                  48, 5
  Federal Management Regulation                   41, 102
  Federal Property Management Regulations         41, 101
  Federal Travel Regulation System                41, Subtitle F
  General                                         41, 300
  Payment From a Non-Federal Source for Travel    41, 304
       Expenses
  Payment of Expenses Connected With the Death    41, 303
       of Certain Employees
  Relocation Allowances                           41, 302
  Temporary Duty (TDY) Travel Allowances          41, 301
Geological Survey                                 30, IV
Government Accountability Office                  4, I
Government Ethics, Office of                      5, XVI
Government National Mortgage Association          24, III
Grain Inspection, Packers and Stockyards          7, VIII; 9, II
     Administration
Harry S. Truman Scholarship Foundation            45, XVIII
Health and Human Services, Department of          2, III; 5, XLV; 45, 
                                                  Subtitle A,
  Centers for Medicare & Medicaid Services        42, IV
  Child Support Enforcement, Office of            45, III
  Children and Families, Administration for       45, II, III, IV, X
  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
  Inspector General (Health Care), Office of      42, V
  Public Health Service                           42, I
  Refugee Resettlement, Office of                 45, IV
Homeland Security, Department of                  2, XXX; 6, I; 8, I
  Coast Guard                                     33, I; 46, I; 49, IV
  Coast Guard (Great Lakes Pilotage)              46, III
  Customs and Border Protection                   19, I
  Federal Emergency Management Agency             44, I
  Human Resources Management and Labor Relations  5, XCVII
       Systems
  Immigration and Customs Enforcement Bureau      19, IV
  Transportation Security Administration          49, XII
HOPE for Homeowners Program, Board of Directors   24, XXIV
     of
Housing and Urban Development, Department of      2, XXIV; 5, LXV; 24, 
                                                  Subtitle B
  Community Planning and Development, Office of   24, V, VI
       Assistant Secretary for
  Equal Opportunity, Office of Assistant          24, I
       Secretary for
  Federal Acquisition Regulation                  48, 24
  Federal Housing Enterprise Oversight, Office    12, XVII
       of
  Government National Mortgage Association        24, III
  Housing--Federal Housing Commissioner, Office   24, II, VIII, X, XX
       of Assistant Secretary for
  Housing, Office of, and Multifamily Housing     24, IV
       Assistance Restructuring, Office of
  Inspector General, Office of                    24, XII
  Public and Indian Housing, Office of Assistant  24, IX
       Secretary for
  Secretary, Office of                            24, Subtitle A, VII
Housing--Federal Housing Commissioner, Office of  24, II, VIII, X, XX
     Assistant Secretary for
Housing, Office of, and Multifamily Housing       24, IV
     Assistance Restructuring, Office of
Human Development Services, Office of             45, XIII
Immigration and Customs Enforcement Bureau        19, IV
Immigration Review, Executive Office for          8, V
Independent Counsel, Office of                    28, VII
Indian Affairs, Bureau of                         25, I, V

[[Page 342]]

Indian Affairs, Office of the Assistant           25, VI
     Secretary
Indian Arts and Crafts Board                      25, II
Indian Health Service                             25, V
Industry and Security, Bureau of                  15, VII
Information Resources Management, Office of       7, XXVII
Information Security Oversight Office, National   32, XX
     Archives and Records Administration
Inspector General
  Agriculture Department                          7, XXVI
  Health and Human Services Department            42, V
  Housing and Urban Development Department        24, XII, XV
Institute of Peace, United States                 22, XVII
Inter-American Foundation                         5, LXIII; 22, X
Interior Department                               2, XIV
  American Indians, Office of the Special         25, VII
       Trustee
  Bureau of Ocean Energy Management, Regulation,  30, II
       and Enforcement
  Endangered Species Committee                    50, IV
  Federal Acquisition Regulation                  48, 14
  Federal Property Management Regulations System  41, 114
  Fish and Wildlife Service, United States        50, I, IV
  Geological Survey                               30, IV
  Indian Affairs, Bureau of                       25, I, V
  Indian Affairs, Office of the Assistant         25, VI
       Secretary
  Indian Arts and Crafts Board                    25, II
  Land Management, Bureau of                      43, II
  National Indian Gaming Commission               25, III
  National Park Service                           36, I
  Natural Resource Revenue, Office of             30, XII
  Ocean Energy Management, Bureau of              30, V
  Reclamation, Bureau of                          43, I
  Secretary of the Interior, Office of            2, XIV; 43, Subtitle A
  Surface Mining Reclamation and Enforcement,     30, VII
       Office of
Internal Revenue Service                          26, I
International Boundary and Water Commission,      22, XI
     United States and Mexico, United States 
     Section
International Development, United States Agency   22, II
     for
  Federal Acquisition Regulation                  48, 7
International Development Cooperation Agency,     22, XII
     United States
International Joint Commission, United States     22, IV
     and Canada
International Organizations Employees Loyalty     5, V
     Board
International Trade Administration                15, III; 19, III
International Trade Commission, United States     19, II
Interstate Commerce Commission                    5, XL
Investment Security, Office of                    31, VIII
James Madison Memorial Fellowship Foundation      45, XXIV
Japan-United States Friendship Commission         22, XVI
Joint Board for the Enrollment of Actuaries       20, VIII
Justice Department                                2, XXVIII; 5, XXVIII; 28, 
                                                  I, XI; 40, IV
  Alcohol, Tobacco, Firearms, and Explosives,     27, II
       Bureau of
  Drug Enforcement Administration                 21, II
  Federal Acquisition Regulation                  48, 28
  Federal Claims Collection Standards             31, IX
  Federal Prison Industries, Inc.                 28, III
  Foreign Claims Settlement Commission of the     45, V
       United States
  Immigration Review, Executive Office for        8, V
  Offices of Independent Counsel                  28, VI
  Prisons, Bureau of                              28, V
  Property Management Regulations                 41, 128
Labor Department                                  5, XLII
  Employee Benefits Security Administration       29, XXV
  Employees' Compensation Appeals Board           20, IV
  Employment and Training Administration          20, V
  Employment Standards Administration             20, VI

[[Page 343]]

  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
  Office of Workers' Compensation Programs        20, VII
  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
  Copyright Royalty Board                         37, III
  U.S. 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, LXIV
Micronesian Status Negotiations, Office for       32, XXVII
Millennium Challenge Corporation                  22, XIII
Mine Safety and Health Administration             30, I
Minority Business Development Agency              15, XIV
Miscellaneous Agencies                            1, IV
Monetary Offices                                  31, I
Morris K. Udall Scholarship and Excellence in     36, XVI
     National Environmental Policy Foundation
Museum and Library Services, Institute of         2, XXXI
National Aeronautics and Space Administration     2, XVIII; 5, LIX; 14, V
  Federal Acquisition Regulation                  48, 18
National Agricultural Library                     7, XLI
National Agricultural Statistics Service          7, XXXVI
National and Community Service, Corporation for   2, XXII; 45, XII, XXV
National Archives and Records Administration      2, XXVI; 5, LXVI; 36, XII
  Information Security Oversight Office           32, XX
National Capital Planning Commission              1, IV
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              5, LXXXVI; 12, VII
National Crime Prevention and Privacy Compact     28, IX
     Council
National Drug Control Policy, Office of           21, III
National Endowment for the Arts                   2, XXXII
National Endowment for the Humanities             2, XXXIII
National Foundation on the Arts and the           45, XI
     Humanities
National Highway Traffic Safety Administration    23, II, III; 47, VI; 49, V
National Imagery and Mapping Agency               32, I
National Indian Gaming Commission                 25, III
National Institute for Literacy                   34, XI
National Institute of Food and Agriculture        7, XXXIV
National Institute of Standards and Technology    15, II
National Intelligence, Office of Director of      32, XVII
National Labor Relations Board                    5, LXI; 29, I
National Marine Fisheries Service                 50, II, IV
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

[[Page 344]]

National Science Foundation                       2, XXV; 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, IV
     Administration
National Transportation Safety Board              49, VIII
Natural Resources Conservation Service            7, VI
Natural Resource Revenue, Office of               30, XII
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                     2, XX; 5, XLVIII; 10, I
  Federal Acquisition Regulation                  48, 20
Occupational Safety and Health Administration     29, XVII
Occupational Safety and Health Review Commission  29, XX
Ocean Energy Management, Bureau of                30, V
Offices of Independent Counsel                    28, VI
Office of Workers' Compensation Programs          20, VII
Oklahoma City National Memorial Trust             36, XV
Operations Office                                 7, XXVIII
Overseas Private Investment Corporation           5, XXXIII; 22, VII
Patent and Trademark Office, United States        37, I
Payment From a Non-Federal Source for Travel      41, 304
     Expenses
Payment of Expenses Connected With the Death of   41, 303
     Certain Employees
Peace Corps                                       2, XXXVII; 22, III
Pennsylvania Avenue Development Corporation       36, IX
Pension Benefit Guaranty Corporation              29, XL
Personnel Management, Office of                   5, I, XXXV; 45, VIII
  Human Resources Management and Labor Relations  5, XCVII
       Systems, Department of Homeland Security
  Federal Acquisition Regulation                  48, 17
  Federal Employees Group Life Insurance Federal  48, 21
       Acquisition Regulation
  Federal Employees Health Benefits Acquisition   48, 16
       Regulation
Pipeline and Hazardous Materials Safety           49, I
     Administration
Postal Regulatory Commission                      5, XLVI; 39, III
Postal Service, United States                     5, LX; 39, I
Postsecondary Education, Office of                34, VI
President's Commission on White House             1, IV
     Fellowships
Presidential Documents                            3
Presidio Trust                                    36, X
Prisons, Bureau of                                28, V
Privacy and Civil Liberties Oversight Board       6, X
Procurement and Property Management, Office of    7, XXXII
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
Recovery Accountability and Transparency Board    4, II
Refugee Resettlement, Office of                   45, IV
Relocation Allowances                             41, 302
Research and Innovative Technology                49, XI
     Administration
Rural Business-Cooperative Service                7, XVIII, XLII, L
Rural Development Administration                  7, XLII
Rural Housing Service                             7, XVIII, XXXV, L
Rural Telephone Bank                              7, XVI
Rural Utilities Service                           7, XVII, XVIII, XLII, L
Saint Lawrence Seaway Development Corporation     33, IV

[[Page 345]]

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                5, XXXIV; 17, II
Selective Service System                          32, XVI
Small Business Administration                     2, XXVII; 13, I
Smithsonian Institution                           36, V
Social Security Administration                    2, XXIII; 20, III; 48, 23
Soldiers' and Airmen's Home, United States        5, XI
Special Counsel, Office of                        5, VIII
Special Education and Rehabilitative Services,    34, III
     Office of
State Department                                  2, VI; 22, I; 28, XI
  Federal Acquisition Regulation                  48, 6
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
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                     2, XII; 5, L
  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; 47, IV; 49, V
  Pipeline and Hazardous Materials Safety         49, I
       Administration
  Saint Lawrence Seaway Development Corporation   33, IV
  Secretary of Transportation, Office of          14, II; 49, Subtitle A
  Surface Transportation Board                    49, X
  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 and Border Protection                   19, I
  Engraving and Printing, Bureau of               31, VI
  Federal Acquisition Regulation                  48, 10
  Federal Claims Collection Standards             31, IX
  Federal Law Enforcement Training Center         31, VII
  Financial Crimes Enforcement Network            31, X
  Fiscal Service                                  31, II
  Foreign Assets Control, Office of               31, V
  Internal Revenue Service                        26, I
  Investment Security, Office of                  31, VIII
  Monetary Offices                                31, I
  Secret Service                                  31, IV
  Secretary of the Treasury, Office of            31, Subtitle A
  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
U.S. Copyright Office                             37, II

[[Page 346]]

Utah Reclamation Mitigation and Conservation      43, III
     Commission
Veterans Affairs Department                       2, VIII; 38, I
  Federal Acquisition Regulation                  48, 8
Veterans' Employment and Training Service,        41, 61; 20, IX
     Office of the Assistant Secretary for
Vice President of the United States, Office of    32, XXVIII
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 347]]



List of CFR Sections Affected



All changes in this volume of the Code of Federal Regulations (CFR) that 
were made by documents published in the Federal Register since January 
1, 2009 are enumerated in the following list. Entries indicate the 
nature of the changes effected. Page numbers refer to Federal Register 
pages. The user should consult the entries for chapters, parts and 
subparts as well as sections for revisions.
For changes to this volume of the CFR prior to this listing, consult the 
annual edition of the monthly List of CFR Sections Affected (LSA). The 
LSA is available at www.fdsys.gov. For changes to this volume of the CFR 
prior to 2001, see the ``List of CFR Sections Affected, 1949-1963, 1964-
1972, 1973-1985, and 1986-2000'' published in 11 separate volumes. The 
``List of CFR Sections Affected 1986-2000'' is available at 
www.fdsys.gov.

                                  2009

21 CFR
                                                                   74 FR
                                                                    Page
Chapter II
1300 Authority citation revised....................................15619
1300.01 (b)(4)(xiii) through (lx) redesignated as (b)(4)(xiv) 
        through (lxi); new (b)(4)(xiii) added; new (b)(4)(xvii) 
        through (lxi) further redesignated as (b)(4)(xviii) 
        through (lxii); new (b)(4)(xvii) added; new (b)(4)(xlvii) 
        through (lxii) redesignated as (b)(4)(xlviii) through 
        (lxiii); new (b)(4)(xlvii) added...........................63609
1300.04 Added; interim.............................................15619
1301 Authority citation revised....................................15621
1301.11 Revised; interim...........................................15621
1301.13 (e)(1)(iv) and (3) revised; interim........................15622
1301.19 Added; interim.............................................15622
1301.52 (a) revised; interim.......................................15623
1304 Authority citation revised....................................15623
1304.01 Revised; interim...........................................15623
1304.40 Undesignated center heading and section added; interim.....15623
1304.45 Added; interim.............................................15623
1304.50 Added; interim.............................................15623
1304.55 Added; interim.............................................15623
1306 Authority citation revised....................................15624
1306.09 Added; interim.............................................15624
1308.12 (c)(28) added..............................................23793
1308.14 (c)(23) through (51) redesignated as (c)(24) through (52); 
        new (c)(23) added..........................................51236
1308.15 (e)(1) revised; (e)(2) added...............................23790
1308.22 Table amended; interim.....................................44283

                                  2010

21 CFR
                                                                   75 FR
                                                                    Page
Chapter II
1300.03 Added; interim; eff. 6-1-10................................16304
1301.03 Revised....................................................10676
1301.13 (e)(2) revised.............................................10676
1301.14 (a) revised................................................10676
1301.18 (c) revised................................................10676
1301.51 Revised....................................................10676
1301.52 (b) and (c) revised........................................10676
1301.71 (d) revised................................................10677
1303.12 (b) and (d) revised........................................10677
1303.22 Introductory text revised..................................10677
1304.03 (c) revised; (h) added; interim; eff. 6-1-10...............16306
1304.04 (d) revised................................................10677
    (b) introductory text, (1) and (h) revised; interim; eff. 6-1-
10.................................................................16306
1304.06 Added; interim; eff. 6-1-10................................16306

[[Page 348]]

1304.31 (a) revised................................................10677
1304.32 (a) revised................................................10678
1304.33 (a) revised................................................10678
1306 Policy statement..............................................61613
1306.05 Revised; interim; eff. 6-1-10..............................16307
1306.08 Added; interim; eff. 6-1-10................................16307
1306.11 (a), (c), (d)(1) and (4) revised; interim; eff. 6-1-10.....16307
1306.13 (a) revised; interim; eff. 6-1-10..........................16308
1306.15 (a)(1) revised; interim; eff. 6-1-10.......................16308
1306.21 (a) and (c) revised; interim; eff. 6-1-10..................16308
1306.22 Revised; interim; eff. 6-1-10..............................16308
1306.25 Revised; interim; eff. 6-1-10..............................16309
1307.03 Revised....................................................10678
1307.22 Revised....................................................10678
1308 Technical correction..........................................47451
1308.11 (g) revised................................................37301
    (d)(15) through (34) redesignated as (d)(16) through (35); new 
(d)(15) added......................................................79300
1308.12 (g)(3) added...............................................37299
1308.21 (a) revised................................................10678
1308.22 Regulation at 74 FR 44283 confirmed........................13679
1308.23 (b) revised................................................10678
1308.24 (d) and (i) revised........................................10678
1308.25 (a) revised................................................10679
1308.26 (a) revised................................................10679
1308.31 (a) revised................................................10679
1308.32 Revised....................................................10679
1308.33 (b) revised................................................10679
1308.34 Revised....................................................10679
1308.43 (b) revised................................................10679
1309 Authority citation revised.....................................4980
1309.03 Revised....................................................10680
1309.11 Revised.....................................................4980
1309.12 Revised.....................................................4980
1309.21 Revised.....................................................4980
1309.22 Revised.....................................................4981
1309.23 (a) revised.................................................4981
1309.24 Revised.....................................................4981
1309.25 (c) added...................................................4982
1309.32 (c) revised................................................10680
1309.33 (a) revised................................................10680
1309.61 Revised....................................................10680
1309.71 (c) revised................................................10680
1310.04 (f)(1)(i) table, (ii) and (g)(1)(i) through (vii) revised; 
        (g)(1)(viii) and (ix) added................................38922
1310.05 (c), (d), (e)(1) and (2) revised...........................10680
1310.06 (d), (g) and (h)(5) revised................................10681
1310.09 (k) added..................................................37306
1310.10 (a) introductory text revised..............................38922
1310.12 (c) table amended; (d)(2) revised..........................37306
1310.13 (b) revised................................................10681
    (i) table revised..............................................53869
1310.14 Added......................................................38922
1310.21 (b) introductory text revised..............................10681
1311 Heading revised; interim; eff. 6-1-10.........................16310
1311.01 Revised; interim; eff. 6-1-10..............................16310
1311.02 Revised; interim; eff. 6-1-10..............................16310
1311.08 Revised; interim; eff. 6-1-10..............................16310
1311.100--1311.305 (Subpart C) Added; interim; eff. 6-1-10.........16310
1312.12 (a) revised................................................10681
1312.16 (b) revised................................................10682
1312.18 (b) revised................................................10682
1312.19 (b) revised................................................10682
1312.22 (a) and (d)(8) revised.....................................10682
1312.24 (a) revised................................................10682
1312.27 (a) and (b)(5)(iv) revised.................................10683
1312.28 (d) revised................................................10683
1312.31 (b) introductory text revised..............................10683
1312.32 (a) revised................................................10683
1313.12 (b) and (e) introductory text revised......................10683
1313.13 (d) added; eff. 5-4-10.....................................10171
1313.21 (b) and (e) introductory text revised......................10683
1313.22 (e) revised................................................10683
1313.24 (e) revised................................................10684
1313.31 (b) introductory text revised..............................10684
1313.32 (b)(1) revised.............................................10684
1313.42 Added; eff. 5-4-10.........................................10172
1314.110 (a)(1) and (2) revised....................................10684
1315.22 Introductory text revised..................................10684
1315.32 (e) and (g) revised........................................10684
1315.34 (d) revised................................................10684
1315.36 (b) revised................................................10685
1316.23 (b) introductory text revised..............................10685
1316.24 (b) introductory text revised..............................10685

[[Page 349]]

1316.45 Revised....................................................10685
1316.46 (a) revised................................................10685
1316.47 (a) revised................................................10685
1316.48 Revised....................................................10685
1321 Added.........................................................10685

                                  2011

21 CFR
                                                                   76 FR
                                                                    Page
Chapter II
1300 Policy statement..............................................64813
1301.52 (a) revised................................................61564
1304 Policy statement..............................................64813
1306 Policy statement...............................................6481
1308.11 (g)(1) through (5) added...................................11078
    (g)(6), (7) and (8) added......................................65374
1308.14 (c)(5) through (52) redesignated as (c)(6) through (53); 
        new (c)(5) added...........................................77358
1308.15 (e)(1) and (2) redesignated as (e)(2) and (3); new (e)(1) 
        added......................................................77899
1309.62 (a) revised................................................61564
1310.02 (a)(30) added; eff. 5-2-11.................................17781
1310.04 (g)(1)(ii) through (ix) redesignated as (g)(1)(iii) 
        through (x); new (g)(1)(ii) added; eff. 5-2-11.............17781
1310.09 (l) added; eff. 5-2-11.....................................17781
    (m) added......................................................31829
1310.12 Amended; eff. 5-2-11.......................................17781
    (a) revised; (c) table amended.................................31830
1310.13 (e) and (i) introductory text revised......................31830
1311 Policy statement..............................................64813
1314.30 Revised....................................................74698
1314.101 Added; interim............................................20523
1314.102 Added; interim............................................20523
1314.103 Added; interim............................................20524

                                  2012

21 CFR
                                                                   77 FR
                                                                    Page
Chapter II
1300.01 (b) revised.................................................4230
    (b) amended....................................................44461
1300.02 (b) revised.................................................4233
1300.03 Reinstated; CFR correction.................................58767
1301.13 (e)(1) revised; eff. 4-16-12...............................15249
1303.11 (c) amended.................................................4235
1304.03 (a) amended.................................................4235
1305.03 (d) revised.................................................4235
1306.24 Heading revised.............................................4235
1308 Order..................................................12201, 64032
1308.11 (d)(8) revised..............................................4235
1308.12 (b)(4) revised..............................................4235
1308.13 (b) introductory text revised...............................4236
1309 Authority citation revised; eff. 4-16-12......................15250
1309.11 Revised; eff. 4-16-12......................................15250
1309.21 (a)(2) revised..............................................4236
    (c) revised; eff. 4-16-12......................................15250
1309.24 (b), (c) and (d) revised....................................4236
1309.62 (a) amended.................................................4236
1310.04 (f)(1)(ii) revised; (g) amended.............................4236
1310.05 (d) amended; (f)(2) revised.................................4236
1310.06 (e)(1), (4), (f)(1), (4) and (h)(5) revised.................4236
1310.09 (b) amended.................................................4237
1310.10 Heading revised; (a) amended................................4237
1310.14 Introductory text revised...................................4237
1312.18 (d) revised.................................................4237
1312.21 (c) revised.................................................4237
1312.25 Amended.....................................................4237
1312.28 (c) revised.................................................4237
1313.12 (d) revised.................................................4237
1313.13 (c)(1) revised..............................................4237
1313.14 (c) revised.................................................4237
1313.21 (c)(1) revised..............................................4237
1313.24 (a) revised.................................................4237
1313.31 (b)(5) and (11) revised.....................................4237
1313.32 (b)(2) revised..............................................4238
1313.33 (c)(1) and (4) revised......................................4238
1314.45 Introductory text revised...................................4238
1314.115 (a)(2) revised.............................................4238
1316.03 (d) revised.................................................4238
1316.42 (g) revised.................................................4238
1316.71--1316.81 (Subpart E) Removed...............................56101
1316.90--1316.99 (Subpart F) Removed...............................56101

                                  2013

21 CFR
                                                                   78 FR
                                                                    Page
Chapter II
1308.11 (g) redesignated as (h); (d)(36) through (46) and new (g) 
        added; new (h)(1) revised....................................665
    (d)(47) added..................................................21825
    (h)(9), (10) and (11) added....................................28738
    (h)(12), (13) and (14) added...................................68719

[[Page 350]]

1308.13 (c)(11) through (14) redesignated as (c)(12) through (15); 
        new (c)(11) added..........................................72016
1308.14 (e) and (f) redesignated as (f) and (g); new (e) added.....26705

                                  2014

   (Regulations published from January 1, 2014, through April 1, 2014)

21 CFR
                                                                   79 FR
                                                                    Page
Chapter II
1308.11 (h)(15) through (18) added..................................7582
    (h)(19) through (28) added.....................................12942
1308.14 (c)(1) through (53) redesignated as (c)(2) through (54); 
        new (c)(1) added...........................................10989


                                  [all]