[Title 21 CFR ]
[Code of Federal Regulations (annual edition) - April 1, 2023 Edition]
[From the U.S. Government Publishing Office]
[[Page i]]
Title 21
Food and Drugs
________________________
Part 1300 to End
Revised as of April 1, 2023
Containing a codification of documents of general
applicability and future effect
As of April 1, 2023
Published by the Office of the Federal Register
National Archives and Records Administration as a
Special Edition of the Federal Register
[[Page ii]]
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[[Page iii]]
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 295
Finding Aids:
Table of CFR Titles and Chapters........................ 315
Alphabetical List of Agencies Appearing in the CFR...... 335
List of CFR Sections Affected........................... 345
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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.
----------------------------
[[Page v]]
EXPLANATION
The Code of Federal Regulations is a codification of the general and
permanent rules published in the Federal Register by the Executive
departments and agencies of the Federal Government. The Code is divided
into 50 titles which represent broad areas subject to Federal
regulation. Each title is divided into chapters which usually bear the
name of the issuing agency. Each chapter is further subdivided into
parts covering specific regulatory areas.
Each volume of the Code is revised at least once each calendar year
and issued on a quarterly basis approximately as follows:
Title 1 through Title 16.................................as of January 1
Title 17 through Title 27..................................as of April 1
Title 28 through Title 41...................................as of July 1
Title 42 through Title 50................................as of October 1
The appropriate revision date is printed on the cover of each
volume.
LEGAL STATUS
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HOW TO USE THE CODE OF FEDERAL REGULATIONS
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OMB CONTROL NUMBERS
The Paperwork Reduction Act of 1980 (Pub. L. 96-511) requires
Federal agencies to display an OMB control number with their information
collection request.
[[Page vi]]
Many agencies have begun publishing numerous OMB control numbers as
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PAST PROVISIONS OF THE CODE
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``[RESERVED]'' TERMINOLOGY
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This material, like any other properly issued regulation, has the force
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(a) The incorporation will substantially reduce the volume of
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(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
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What if the material incorporated by reference cannot be found? If
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CFR INDEXES AND TABULAR GUIDES
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separate volume, revised annually as of January 1, entitled CFR Index
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alphabetical list of agencies publishing in the CFR are also included in
this volume.
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that volume.
[[Page vii]]
The Federal Register Index is issued monthly in cumulative form.
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the revision dates of the 50 CFR titles.
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available at www.ecfr.gov.
Oliver A. Potts,
Director,
Office of the Federal Register
April 1, 2023
[[Page ix]]
THIS TITLE
Title 21--Food and Drugs is composed of nine volumes. The parts in
these volumes are arranged in the following order: Parts 1-99, 100-169,
170-199, 200-299, 300-499, 500-599, 600-799, 800-1299 and 1300 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, 2023.
For this volume, Michele Bugenhagen was Chief Editor. The Code of
Federal Regulations publication program is under the direction of John
Hyrum Martinez, assisted by Stephen J. Frattini.
[[Page 1]]
TITLE 21-FOOD AND DRUGS
(This book contains part 1300 to end)
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Part
chapter ii--Drug Enforcement Administration, Department of
Justice................................................... 1300
chapter iii--Office of National Drug Control Policy......... 1401
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CHAPTER II--DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE
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Part Page
1300 Definitions................................. 5
1301 Registration of manufacturers, distributors,
and dispensers of controlled substances. 23
1302 Labeling and packaging requirements for
controlled substances................... 62
1303 Quotas...................................... 64
1304 Records and reports of registrants.......... 73
1305 Orders for schedule I and II controlled
substances.............................. 94
1306 Prescriptions............................... 105
1307 Miscellaneous............................... 117
1308 Schedules of controlled substances.......... 119
1309 Registration of manufacturers, distributors,
importers and exporters of list I
chemicals............................... 148
1310 Records and reports of listed chemicals and
certain machines; importation and
exportation of certain machines......... 160
1311 Requirements for electronic orders and
prescriptions........................... 189
1312 Importation and exportation of controlled
substances.............................. 210
1313 Importation and exportation of list I and
list II chemicals....................... 234
1314 Retail sale of scheduled listed chemical
products................................ 247
1315 Importation and production quotas for
ephedrine, pseudoephedrine, and
phenylpropanolamine..................... 255
1316 Administrative functions, practices, and
procedures.............................. 265
1317 Disposal.................................... 278
1318 Controls to satisfy the requirements of the
Act applicable to the manufacturing of
marihuana............................... 287
1321 DEA Mailing addresses....................... 291
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.
1300.05 Definitions relating to the disposal of controlled substances.
Authority: 21 U.S.C. 802, 821, 822, 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, 1312, and 1317 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)
[[Page 6]]
(34) 17[alpha]-methyl-3[beta],17[beta]-dihydroxy-5a-androstane
(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.
Collection means to receive a controlled substance for the purpose
of destruction from an ultimate user, a person lawfully entitled to
dispose of an ultimate user decedent's property, or a long-term care
facility on behalf of an ultimate user who resides or has resided at
that facility. The term collector means a registered manufacturer,
distributor, reverse distributor, narcotic treatment program, hospital/
clinic with an on-site pharmacy, or retail pharmacy that is authorized
under this chapter to so receive a controlled substance for the purpose
of destruction.
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.
Competent national authority, for purposes of importation and
exportation of controlled substances and listed chemicals, means an
entity lawfully entitled to authorize the import and export of
controlled substances, and to regulate or enforce national controls over
listed chemicals, and included as such in the directory of ``Competent
National Authorities Under the International Drug Control Treaties''
published by the United Nations Office on Drugs and Crime. For purposes
of exports of narcotic drugs, the term also includes freely associated
states authorized to receive such exports pursuant to 48 U.S.C. 1972.
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.
[[Page 8]]
Controlled substance has the meaning given in section 802(6) of
Title 21, United States Code (U.S.C.).
Customs officer means either an Officer of the Customs as defined in
19 U.S.C. 1401(i) (that is, of the U.S. Customs and Border Protection),
or any individual duly authorized to accept entries of merchandise, to
collect duties, and to enforce the customs laws of any commonwealth,
territory, or possession of the United States.
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 such article from the United States (whether or not such taking out
or removal constitutes an exportation within the meaning of the customs
laws, export control laws enforced by other agencies, or 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 (excluding reverse 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 the customs territory of the United
States from any place outside thereof (but within the United States), or
into the United States from any place outside thereof (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
[[Page 9]]
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 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.
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.
[[Page 10]]
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.
Mobile Narcotic Treatment Program means a narcotic treatment program
(NTP) operating from a motor vehicle, as defined in this section, that
serves as a mobile component (conveyance) and is operating under the
registration of the NTP, and engages in maintenance and/or
detoxification treatment with narcotic drugs in schedules II-V, at a
location or locations remote from, but within the same State as, its
registered location. Operating a mobile NTP is a coincident activity of
an existing NTP, as listed in Sec. 1301.13(e) of this chapter.
Motor vehicle means a vehicle propelled under its own motive power
and lawfully used on public streets, roads, or highways with more than
three wheels in contact with the ground. This term does not include a
trailer.
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 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.
[[Page 11]]
Port of entry means, unless distinguished as being a foreign port of
entry, any place at which a customs officer is duly authorized to accept
entries of merchandise, to collect duties, and to enforce the various
provisions of the customs laws of the United States (whether or not such
place is a port of entry as defined in title 19 of the United States
Code or its associated implementing regulations). Examples of ports of
entry include, but are not limited to, places designated as ports of
entry or customs stations in title 19 of the Code of Federal Regulations
or by the governing customs authority of that area. When shipments are
transported under U.S. Customs and Border Protection's immediate
transportation procedures, the port of entry shall be the port of final
destination.
Port of export means, unless distinguished as being a foreign port
of export, any place under the control of a customs officer where goods
are loaded on an aircraft, vessel or other conveyance for export outside
of the United States. For goods loaded aboard an aircraft or vessel in
the United States, that stops at several ports before departing the
United States, the port of export is the first port where the goods were
actually loaded. For goods off-loaded from the original conveyance to
another conveyance (even if the aircraft or vessel belongs to the same
carrier) at any port subsequent to the port where the first on-loading
occurred in the United States, the port where the goods were loaded onto
the last conveyance before departing the United States is the port of
export.
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).
Return information means supplemental information required to be
reported to the Administration following an import or export transaction
containing the particulars of the transaction and any other information
as the Administration may specify.
Reverse distribute means to acquire controlled substances from
another registrant or law enforcement for the purpose of:
(1) Return to the registered manufacturer or another registrant
authorized by the manufacturer to accept returns on the manufacturer's
behalf; or
(2) Destruction.
Reverse distributor is a person registered with the Administration
as a reverse distributor.
Supplier means any registered person entitled to fill order forms
pursuant to Sec. 1305.06 of this chapter.
United States, when used in a geographic sense, means all places and
waters, continental or insular, subject to the jurisdiction of the
United States, which, in addition to the customs territory of the United
States, include but are not limited to the U.S. Virgin Islands, Guam,
American
[[Page 12]]
Samoa, and the Northern Mariana Islands.
[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; 79 FR 53559, Sept. 9, 2014; 81 FR
97018, Dec. 30, 2016; 86 FR 33883, June 28, 2021]
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 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.
Competent national authority, for purposes of importation and
exportation of controlled substances and listed chemicals, means an
entity lawfully entitled to authorize the import and export of
controlled substances, and to regulate or enforce national controls over
listed chemicals, and included as such in the directory of ``Competent
National Authorities Under the International Drug Control Treaties''
published by the United Nations Office on Drugs and Crime.
Customs officer means either an Officer of the Customs as defined in
19 U.S.C. 1401(i) (that is, of the U.S. Customs and Border Protection),
or any individual duly authorized to accept entries of merchandise, to
collect duties, and to enforce the customs laws of any commonwealth,
territory, or possession of the United States.
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
[[Page 13]]
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 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.
Export means, with respect to any article, any taking out or removal
of such article from the United States (whether or not such taking out
or removal constitutes an exportation within the meaning of the customs
laws, export control laws enforced by other agencies, or related laws of
the United States).
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).
Import means, with respect to any article, any bringing in or
introduction of such article into the customs territory of the United
States from any place outside thereof (but within the United States), or
into the United States from any place outside thereof (whether or not
such bringing in or introduction constitutes an importation within the
meaning of the tariff laws of the United States).
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.
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.
Port of entry, unless distinguished as being a foreign port of
entry, means any place at which a customs officer is duly authorized to
accept entries of merchandise, to collect duties, and to enforce the
various provisions of the customs laws of the United States (whether or
not such place is a port of entry as defined in title 19 of the United
States Code or its associated implementing regulations). Examples of
ports of entry include, but are not limited to, places designated as
ports of entry or customs stations in title 19 of the Code of Federal
Regulations or by the governing customs authority of that area. When
shipments are transported under U.S. Customs and Border Protection
immediate transportation procedures, the port of entry shall be the port
of final destination.
[[Page 14]]
Port of export means, unless distinguished as being a foreign port
of export, any place under the control of a customs officer where goods
are loaded on an aircraft, vessel or other conveyance for export outside
of the United States. For goods loaded aboard an aircraft or vessel in
the United States that stops at several ports before departing the
United States, the port of export is the first port where the goods were
loaded. For goods off-loaded from the original conveyance to another
conveyance (even if the aircraft or vessel belongs to the same carrier)
at any port subsequent to the port where the first on-loading occurred
in the United States, the port where the goods were loaded onto the last
conveyance before departing the United States is the port of export. For
reporting purposes, in the case of an otherwise lawful export occurring
by mail, the port of export is the place of mailing.
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 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
[[Page 15]]
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 ephedrine, 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.
Return information means supplemental information required to be
reported to the Administration following an import or export transaction
containing the particulars of the transaction and any other information
as the Administration may specify.
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.
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.
United States, when used in a geographic sense, means all places and
waters, continental or insular, subject to the jurisdiction of the
United States, which, in addition to the customs territory of the United
States, include but are not limited to the U.S. Virgin Islands, Guam,
American Samoa, and the Northern Mariana Islands.
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; 81
FR 97019, Dec. 30, 2016; 85 FR 68461, Oct. 29, 2020]
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
[[Page 16]]
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;
(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
[[Page 17]]
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 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,
[[Page 18]]
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 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.
[[Page 19]]
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.
(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:
[[Page 20]]
(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 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
[[Page 21]]
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:
(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
[[Page 22]]
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]
Sec. 1300.05 Definitions relating to the disposal of controlled
substances.
(a) Any term not defined in this part or elsewhere in this chapter
shall have the definition set forth in section 102 of the Act (21 U.S.C.
802).
(b) As used in part 1317 of this chapter, the following terms shall
have the meanings specified:
Employee means an employee as defined under the general common law
of agency. Some of the factors relevant to the determination of employee
status include: The hiring party's right to control the manner and means
by which the product is accomplished; the skill required; the source of
the instrumentalities and tools; the location of the work; the duration
of the relationship between the parties; whether the hiring party has
the right to assign additional projects to the hired party; the extent
of the hired party's discretion over when and how long to work; the
method of payment; the hired party's role in hiring and paying
assistants; whether the work is part of the regular business of the
hiring party; whether the hiring party is in business; the provision of
employee benefits; and the tax treatment of the hired party. Other
applicable factors may be considered and no one factor is dispositive.
The following criteria will determine
[[Page 23]]
whether a person is an employee of a registrant for the purpose of
disposal: The person is directly paid by the registrant; subject to
direct oversight by the registrant; required, as a condition of
employment, to follow the registrant's procedures and guidelines
pertaining to the handling of controlled substances; subject to receive
a performance rating or performance evaluation on a regular/routine
basis from the registrant; subject to disciplinary action by the
registrant; and required to render services at the registrant's
registered location.
Law enforcement officer means a person who is described in paragraph
(1), (2) or (3) of this definition:
(1) Meets all of the following criteria:
(i) Employee of either a law enforcement agency, or law enforcement
component of a Federal agency;
(ii) Is under the direction and control of a Federal, State, tribal,
or local government;
(iii) Acting in the course of his/her official duty; and
(iv) Duly sworn and given the authority by a Federal, State, tribal,
or local government to carry firearms, execute and serve warrants, make
arrests without warrant, and make seizures of property;
(2) Is a Veterans Health Administration (VHA) police officer
authorized by the Department of Veterans Affairs to participate in
collection activities conducted by the VHA; or
(3) Is a Department of Defense (DOD) police officer authorized by
the DOD to participate in collection activities conducted by the DOD.
Non-retrievable means, for the purpose of destruction, the condition
or state to which a controlled substance shall be rendered following a
process that permanently alters that controlled substance's physical or
chemical condition or state through irreversible means and thereby
renders the controlled substance unavailable and unusable for all
practical purposes. The process to achieve a non-retrievable condition
or state may be unique to a substance's chemical or physical properties.
A controlled substance is considered ``non-retrievable'' when it cannot
be transformed to a physical or chemical condition or state as a
controlled substance or controlled substance analogue. The purpose of
destruction is to render the controlled substance(s) to a non-
retrievable state and thus prevent diversion of any such substance to
illicit purposes.
On-site means located on or at the physical premises of the
registrant's registered location. A controlled substance is destroyed
on-site when destruction occurs on the physical premises of the
destroying registrant's registered location. A hospital/clinic has an
on-site pharmacy when it has a pharmacy located on the physical premises
of the registrant's registered location.
[79 FR 53560, Sept. 9, 2014]
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.
[[Page 24]]
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.
1301.29 [Reserved]
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; default.
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 non-practitioners; narcotic
treatment programs and compounders for narcotic treatment
programs; mobile 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 non-practitioners; narcotic
treatment programs and compounders for narcotic treatment
programs; mobile 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, 956, 957, 958, 965 unless otherwise noted.
Source: 36 FR 7778, Apr. 24, 1971, unless otherwise noted.
Redesignated at 38 FR 26609, Sept. 24, 1973.
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.Link
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]
[[Page 25]]
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:
(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 in which he or she practices) 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
[[Page 26]]
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; 81 FR 97019, Dec.
30, 2016]
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 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
[[Page 27]]
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''. Generally, the application fees are not refundable;
however, they may be issued in limited circumstances at the discretion
of the Administrator. These circumstances include: Applicant error, such
as duplicate payments, payment for incorrect business activities, or
payments made by persons who are exempt under this section from
application or renewal fees; DEA error; and death of a registrant within
the first year of the three-year registration cycle. 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)
Summary of Registration Requirements and Limitations
----------------------------------------------------------------------------------------------------------------
Registration Coincident
Business activity Controlled DEA application Application period activities
substances forms fee ($) (years) allowed
----------------------------------------------------------------------------------------------------------------
(i) Manufacturing............. Schedules I -V... New--225........ 3,699 1 Schedules I-V:
Renewal--225a... May distribute
that substance
or class for
which
registration
was issued; may
not distribute
or dispose any
substance or
class for which
not registered.
Schedules II-V:
May conduct
chemical
analysis and
preclinical
research
(including
quality control
analysis) with
substances
listed in those
schedules for
which
authorization
as a mfr. was
issued.
(ii) Distributing............. Schedules I-V.... New--225........ 1,850 1 May acquire
Renewal--225a... Schedules II-V
controlled
substances from
collectors for
the purposes of
destruction.
(iii) Reverse distributing.... Schedules I-V.... New--225........ 1,850 1
Renewal--225a...
[[Page 28]]
(iv) Dispensing or instructing Schedules II-V... New--224 888 3 May conduct
(includes Practitioner, Renewal--224a research and
Hospital/Clinic, Retail Online instructional
Pharmacy, Online Pharmacy, Pharmacy--224c. activities with
Central Fill Pharmacy, those
Teaching Institution). controlled
substances 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
manufacturer an
aqueous or
oleaginous
solution 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. An
online pharmacy
may perform
activities of
retail
pharmacy, as
well as online
pharmacy
activities.
(v) Research.................. Schedule I....... New--225........ 296 1 A researcher may
Renewal--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.
[[Page 29]]
(vi) Research................. Schedules II-V... New--225........ 296 1 May conduct
Renewal--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 in New-363......... 296 1 May operate one
Program (including Schedules II-V. Renewal-363a.... or more mobile
compounder). narcotic
treatment
programs as
defined under
Sec.
1300.01(b),
provided
approval has
been obtained
under Sec.
1301.13(e)(4).
(viii) Importing.............. Schedules I-V.... New--225........ 1,850 1 May distribute
Renewal--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........ 1,850 1
Renewal--225a...
[[Page 30]]
(x) Chemical Analysis......... Schedules I-V.... New--225........ 296 1 May manufacture
Renewal--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 online at
www.DEAdiversion.usdoj.gov. Only applications submitted online through
the secure application portal on DEA's website will be accepted for
processing.
(3) DEA will send renewal notifications via email to registrants
approximately 60 calendar days prior to their registration expiration
date. Registrants are responsible for maintaining a current email
address in application portal on DEA's website. DEA Forms 224a, 225a,
and 363a may be obtained online at www.DEAdiversion.usdoj.gov. Only
renewal applications submitted online through the secure application
portal on DEA's website will be accepted for processing.
(4) For any narcotic treatment program (NTP) intending to operate a
mobile NTP, the registrant must notify the local DEA office, in writing,
of its intent to do so, and the NTP must receive explicit written
approval from the local DEA office prior to operating the mobile NTP.
The mobile NTP may only operate in the same State in which the NTP is
registered.
(i) Registrants are not required to obtain a separate registration
for conveyances (mobile components) utilized by the registrant to
transport controlled substances away from registered locations for
dispensing at unregistered locations as part of a mobile NTP. Vehicles
must possess valid county/city and State information (e.g., a vehicle
information number (license plate number) on file at the registered
location of the NTP. Registrants are also required to provide proper
city/county and State licensing and registration to DEA at the time of
inspection, and prior to transporting controlled substances away from
their registered location.
(ii) A mobile NTP is not permitted to reverse distribute, share, or
transfer controlled substances from one mobile component to another
mobile component while deployed away from the registered location. NTPs
with mobile components are not allowed to modify their registrations to
authorize their mobile components to act as collectors under 21 CFR
1301.51 and 1317.40. Mobile components of NTPs may not function as
hospitals, long-term care facilities, or emergency medical service
vehicles, and will not transport patients.
(iii) A mobile NTP may operate at any remote location or locations
within the same State as its registered location, including correctional
facilities, so long as doing so is otherwise
[[Page 31]]
consistent with applicable Federal, State, tribal, and local laws and
regulations, and so long as the local DEA office, when notified pursuant
to this section, does not otherwise direct.
(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 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; 79 FR 53560, Sept. 9, 2014; 85 FR 44732, July
24, 2020; 85 FR 61601, Sept. 30, 2020; 85 FR 67278, Oct. 22, 2020; 86 FR
33883, June 28, 2021; 87 FR 21022, Apr. 11, 2022]
Sec. 1301.14 Filing of application; acceptance for filing; defective
applications.
(a) All applications for registration shall be submitted for filing
online using the secure application portal at
www.DEAdiversion.usdoj.gov.
(b) Application submitted for filing are dated by the system 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 be rejected by the system, with the applicate receiving error
messages at the time of application.
(c) 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; 87
FR 21022, Apr. 11, 2022]
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
[[Page 32]]
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:
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
[[Page 33]]
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 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
[[Page 34]]
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.
(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
[[Page 35]]
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 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:
[[Page 36]]
(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, Space 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, Space 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, as amended at 86 FR 51822, Sept. 17, 2021]
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.
(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, Space Force, Coast Guard,
Public
[[Page 37]]
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, Space 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, as amended at 86 FR 51822, Sept. 17, 2021]
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 customs
officer, any officer or employee of the U.S. Food and Drug
Administration, and any other Federal or Insular officer who is lawfully
engaged in the enforcement of any Federal law relating to controlled
substances, 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, 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, as amended at 81 FR 97019, Dec. 30, 2016;
87 FR 66955, Nov. 7, 2022]
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
[[Page 38]]
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
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)
[[Page 39]]
________________________________________________________________________
--------------------------------------------------------------------------------------------------------------------------------------------------------
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.
(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)(1)(iv) 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 be distributed only to persons 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 part
1317 of this chapter.
[62 FR 13951, Mar. 24, 1997, as amended at 79 FR 53561, Sept. 9, 2014;
84 FR 68342, Dec. 16, 2019]
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
[[Page 40]]
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 customs
officer 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, as amended at 81 FR 97019, Dec. 30, 2016]
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
[[Page 41]]
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)(ii) of the Act (21 U.S.C. 823(g)(2)(G)(ii)); a
``qualifying other practitioner'' as defined in section 303(g)(2)(G)(iv)
of the Act (21 U.S.C. 823(g)(2)(G)(iv)) who is a nurse practitioner or
physician assistant; or during the period beginning on October 1, 2018
and ending on October 1, 2023, a ``qualifying other practitioner'' as
defined in section 303(g)(2)(G)(iv) of the Act (21 U.S.C.
823(g)(2)(G)(iv)) who is clinical nurse specialist, certified registered
nurse anesthetist, or certified nurse midwife. The Secretary of Health
and Human Services may, by regulation, revise the requirements for being
a qualifying other practitioner.
(ii) With respect to patients to whom the practitioner will provide
such drugs or combinations of drugs, the individual practitioner has the
capacity to provide directly, by referral, or in such other manner as
determined by the Secretary of Health and Human Services:
(A) All drugs approved by the Food and Drug Administration for the
treatment of opioid use disorder, including for maintenance,
detoxification, overdose reversal, and relapse prevention; and
(B) Appropriate counseling and other appropriate ancillary services.
(iii)(A) The total number of patients to whom the individual
practitioner will provide narcotic drugs or combinations of narcotic
drugs under this section at any one time will not exceed the applicable
number. Except as provided in paragraphs (b)(1)(iii)(B) and (C) of this
section, the applicable number is 30.
(B) The applicable number is--
(1) 100 if not sooner than 1 year after the date on which the
practitioner submitted the initial notification, the practitioner
submits a second notification to the Secretary of Health and Human
Services of the need and intent of the practitioner to treat up to 100
patients;
(2) 100 if the practitioner holds additional credentialing, as
defined in 42 CFR 8.2;
(3) 100 if the practitioner provides medication-assisted treatment
using covered medications (as such terms are defined in 42 CFR 8.615) in
a qualified practice setting (as described in 42 CFR 8.615); and
(4) 275 if the practitioner meets the requirements specified in 42
CFR 8.610 through 8.655.
(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 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
[[Page 42]]
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; 83
FR 3074, Jan. 23, 2018; 85 FR 69166, Nov. 2, 2020]
Sec. 1301.29 [Reserved]
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
[[Page 43]]
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 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) Except as provided in paragraph (d) of this section, this
section shall not apply to the manufacture of basic classes of
controlled substances listed in Schedule I or II as an incident to
research or chemical analysis as authorized in Sec. 1301.13(e)(1).
(d) An application for registration to manufacture marihuana that
involves the planting, cultivating, growing, or harvesting of marihuana
shall be subject to the requirements of this section
[[Page 44]]
and the additional requirements set forth in part 1318 of this chapter.
[62 FR 13953, Mar. 24, 1997, as amended at 85 FR 82352, Dec. 18, 2020]
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 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
[[Page 45]]
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.
(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, as amended at 81 FR 97019, Dec. 30, 2016]
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 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
[[Page 46]]
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 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
[[Page 47]]
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 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.
[[Page 48]]
(d)(1) When to File: Hearing Request. A party that wishes to request
a hearing in response to an order to show cause must file with the
Office of the Administrative Law Judges and serve on DEA such request no
later than 30 days following the date of receipt of the order to show
cause. Service of the request on DEA shall be accomplished by sending it
to the address, or email address, provided in the order to show cause.
(2) When to File: Answer. A party requesting a hearing shall also
file with the Office of the Administrative Law Judges and serve on DEA
an answer to the order to show cause no later than 30 days following the
date of receipt of the order to show cause. A party shall also serve its
answer on DEA at the address, or the email address, provided in the
order to show cause. The presiding officer may, upon a showing of good
cause by the party, consider an answer that has been filed out of time.
(3) Contents of Answer; Effect of Failure to Deny. For each factual
allegation in the order to show cause, the answer shall specifically
admit, deny, or state that the party does not have and is unable to
obtain sufficient information to admit or deny the allegation. When a
party intends in good faith to deny only a part of an allegation, the
party shall specify so much of it as is true and shall deny only the
remainder. A statement of a lack of information shall have the effect of
a denial. Any factual allegation not denied shall be deemed admitted.
(4) Amendments. Prior to the issuance of the prehearing ruling, a
party may as a matter of right amend its answer one time. Subsequent to
the issuance of the prehearing ruling, a party may amend its answer only
with leave of the presiding officer. Leave shall be freely granted when
justice so requires.
(e) When authorized by the Administrator, any agent of the
Administration may serve the order to show cause.
[62 FR 13955, Mar. 24, 1997; 87 FR 68044, Nov. 14, 2022]
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; default.
(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
[[Page 49]]
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)(1) Any person entitled to a hearing pursuant to Sec. 1301.32 or
1301.34 through 36 who fails to file a timely request for a hearing
shall be deemed to have waived their right to a hearing and to be in
default, unless the registrant/applicant establishes good cause for
failing to file a timely hearing request. Any person who has failed to
timely request a hearing under paragraph (a) of this section may seek to
be excused from the default by filing a motion with the Office of
Administrative Law Judges establishing good cause to excuse the default
no later than 45 days after the date of receipt of the order to show
cause. Thereafter, any person who has failed to timely request a hearing
under paragraph (a) of this section and seeks to be excused from the
default shall file such motion with the Office of the Administrator,
which shall have exclusive authority to rule on the motion.
(2) Any person who has requested a hearing pursuant to this section
but who fails to timely file an answer and who fails to demonstrate good
cause for failing to timely file an answer, shall be deemed to have
waived their right to a hearing and to be in default. Upon motion of
DEA, the presiding officer shall then enter an order terminating the
proceeding.
(3) In the event DEA fails to prosecute or a person who has
requested a hearing fails to plead (including by failing to file an
answer) or otherwise defend, said party shall be deemed to be in default
and the opposing party may move to terminate the proceeding. Upon such
motion, the presiding officer shall then enter an order terminating the
proceeding, absent a showing of good cause by the party deemed to be in
default. Upon termination of the proceeding by the presiding officer, a
party may seek relief only by filing a motion establishing good cause to
excuse its default with the Office of the Administrator.
(d) If any person entitled to participate in a hearing pursuant to
this section fails to file a notice of appearance either as part of a
hearing request or separately, or if such person so files and fails to
appear at the hearing, such person shall be deemed to have waived their
opportunity to participate in the hearing, unless such person shows good
cause for such failure.
(e) A default, unless excused, shall be deemed to constitute a
waiver of the registrant's/applicant's right to a hearing and an
admission of the factual allegations of the order to show cause.
(f)(1) In the event that a registrant/applicant is deemed to be in
default pursuant to paragraph (c)(1) of this section, and has not
established good cause to be excused from the default, or the presiding
officer has issued an order terminating the proceeding pursuant to
paragraphs (c)(2) or (c)(3) of this section, DEA may then file a request
for final agency action with the Administrator, along with a record to
support its request. In such circumstances, the Administrator may enter
a default final order pursuant to Sec. 1316.67 of this chapter.
(2) In the event that DEA is deemed to be in default and the
presiding officer has issued an order terminating the proceeding
pursuant to paragraph (c)(3) of this section, the presiding officer
shall transmit the record to the Administrator for his consideration no
later than five business days after the date of issuance of the order.
Upon termination of the proceeding by the presiding officer, DEA may
seek relief only by filing a motion with the Office of the Administrator
establishing good cause to excuse its default.
(3) A party held to be in default may move to set aside a default
final order issued by the Administrator by filing a motion no later than
30 days from the date of issuance by the Administrator of a default
final order. Any such motion shall be granted only upon a showing of
good cause to excuse the default.
[62 FR 13956, Mar. 24, 1997, as amended at 87 FR 68044, Nov. 14, 2022]
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.
[[Page 50]]
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]
Modification, Transfer and Termination of Registration
Sec. 1301.51 Modification in registration.
(a) 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 written 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. Additionally, such a request may be submitted on-line
at www.DEAdiversion.usdoj.gov.
(1) The request shall contain:
(i) The registrant's name, address, and registration number as
printed on the certificate of registration;
(ii) The substances and/or schedules to be added to the registration
or the new name or address; and
(iii) A signature in accordance with Sec. 1301.13(j).
(2) If the registrant is seeking to handle additional controlled
substances listed in Schedule I for the purpose of research or
instructional activities, the registrant 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.
[[Page 51]]
(b) Any manufacturer, distributor, reverse distributor, narcotic
treatment program, hospital/clinic with an on-site pharmacy, or retail
pharmacy registered pursuant to this part, may apply to modify its
registration to become authorized as a collector by submitting a written
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. Additionally, such request may be submitted
on-line at www.DEAdiversion.usdoj.gov.
(1) The request shall contain:
(i) The registrant's name, address, and registration number as
printed on the certificate of registration;
(ii) The method(s) of collection the registrant intends to conduct
(collection receptacle and/or mail-back program); and
(iii) A signature in accordance with Sec. 1301.13(j).
(2) If a hospital/clinic with an on-site pharmacy or retail pharmacy
is applying for a modification in registration to authorize such
registrant to be a collector to maintain a collection receptacle at a
long-term care facility in accordance with Sec. 1317.80 of this
chapter, the request shall also include the name and physical location
of each long-term care facility at which the hospital/clinic with an on-
site pharmacy, or the retail pharmacy, intends to operate a collection
receptacle.
(c) No fee shall be required for modification. The request for
modification shall be handled in the same manner as an application for
registration. If the modification of 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.
[79 FR 53561, Sept. 9, 2014]
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 part 1317 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:
[[Page 52]]
(1) The name, address, registration number, and authorized business
activity of the registrant discontinuing the business (registrant-
transferor);
(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.
(f) Any registrant that has been authorized as a collector and
desires to discontinue its collection of controlled substances from
ultimate users shall notify the Administration of its intent by
submitting a written notification 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.
Additionally, such notice may be submitted on-line at
www.DEAdiversion.usdoj.gov. When ceasing collection activities of an
authorized mail-back program, the registrant shall provide the
Administration with the name, registered address, and registration
number of the collector that will receive the remaining mail-back
packages in accordance with Sec. 1317.70(e)(3) of this chapter.
[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; 79 FR 53561, Sept. 9,
2014]
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
[[Page 53]]
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:
(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.
[[Page 54]]
(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.
(f) A collector shall not employ, as an agent or employee who has
access to or influence over controlled substances acquired by
collection, any person who has been convicted of any felony offense
relating to controlled substances or who, at any time, had an
application for registration with DEA denied, had a DEA registration
revoked or suspended, or has surrendered a DEA registration for cause.
For purposes of this subsection, ``for cause'' means 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.
[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; 79 FR 53561, Sept. 9, 2014]
Sec. 1301.72 Physical security controls for non-practitioners;
narcotic treatment programs and compounders for narcotic treatment
programs; mobile narcotic treatment programs; storage areas.
(a) Schedules I and II. Raw material, bulk materials awaiting
further processing, 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
Federal Food Drug and Cosmetic Act which shall be subject to the
requirements of paragraph (b) of this section), and sealed mail-back
packages and inner liners acquired in accordance with part 1317 of this
chapter, 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
[[Page 55]]
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:
(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
[[Page 56]]
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 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.
(e) Mobile Narcotic Treatment Programs. (1) For any conveyance
operated as a mobile narcotic treatment program (NTP), a safe must be
installed and used to store narcotic drugs in schedules II-V for the
purpose of maintenance or detoxification treatment, when not located at
the registrant's registered location. The safe must conform to the
requirements set forth in paragraph (a)(1) of this section. The mobile
component must also be equipped with an alarm system that conforms to
the requirements set forth in paragraph (a)(1)(iii) of this section. The
storage area of the mobile component must conform to the accessibility
requirements in paragraph (d) of this section. The storage area for
controlled substances in a mobile component of an NTP must not be
accessible from outside of the vehicle. Personnel transporting the
controlled substances on behalf of the mobile NTP are required to retain
control over all controlled substances when transferring them between
the registered location and the conveyance, while en route to and from
the dispensing location or locations, and when dispensing at the
dispensing location or locations. At all other times during
transportation, all controlled substances must be properly secured in
the safe. Upon completion of the operation of the mobile NTP on a given
day, the conveyance must be immediately returned to the registered
location, and all controlled substances must be removed from the
conveyance and secured within the registered location. After the
conveyance has returned to the registered location and the controlled
substances have been removed, the conveyance may be parked until its
next use at the registered location or any secure, fenced-in area, once
the local DEA office has been notified of the location of this secure,
fenced-in area. All NTPs with mobile
[[Page 57]]
components shall be required to establish a standard operating procedure
to ensure, if the mobile component becomes inoperable (mechanical
failure, accidents, fire, etc.), that all controlled substances on the
inoperable conveyance are accounted for, removed from the inoperable
conveyance, and secured at the registered location.
(2) With regard to the requirement of paragraph (e)(1) of this
section, that upon completion of the operation of the mobile NTP on a
given day, the conveyance must be immediately returned to the registered
location, and all controlled substances must be removed from the
conveyance and secured within the registered location, an NTP may apply
for an exception to this requirement as provided in this paragraph. The
application for such an exception must be submitted in accordance with
Sec. 1307.03 of this chapter and must include the proposed alternate
return period, enhanced security measures, and any other factors the
applicant wishes the Administrator to consider. The Administrator may
grant such an exception in his discretion and will evaluate each
application on a case-by-case basis in determining whether the applicant
has demonstrated exceptional circumstances that warrant the exception.
In making this determination, the Administrator will consider the
applicant's security and recordkeeping as well as any other factors he
deems relevant to determining whether effective controls against
diversion will be maintained.
[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.govinfo.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]
[[Page 58]]
Sec. 1301.74 Other security controls for non-practitioners; narcotic
treatment programs and compounders for narcotic treatment programs;
mobile 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.
(c) The registrant must notify the Field Division Office of the
Administration in his or her area, in writing, of any theft or
significant loss of any controlled substances within one business day of
discovery of the theft or loss. Unless the theft or loss occurs during
an import or export transaction, the supplier is responsible for
reporting all in-transit losses of controlled substances by their agent
or the common or contract carrier selected pursuant to paragraph (e) of
this section, within one business day of discovery of such theft or
loss. In an import transaction, once a shipment has been released by the
customs officer at the port of entry, the importer is responsible for
reporting all in-transit losses of controlled substances by their agent
or the common or contract carrier selected pursuant to paragraph (e) of
this section, within one business day of discovery of such theft or
loss. In an export transaction, the exporter is responsible for
reporting all in-transit losses of controlled substances by their agent
or the common or contract carrier selected pursuant to paragraph (e) of
this section within one business day of discovery of such theft or loss,
until the shipment has been released by the customs officer at the port
of export. The registrant must also complete, and submit to the Field
Division Office in his or her 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
[[Page 59]]
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 thiafentanil, carfentanil,
etorphine hydrochloride and/or diprenorphine to any person, the
registrant must verify that the person is authorized to handle the
substance(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 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 any narcotic treatment program (NTP),
including those receiving treatment at a mobile NTP, will be required to
wait in an area that is physically separated from the narcotic storage
and dispensing area by a physical entrance such as a door or other
entryway. Patients must wait outside of a mobile NTP component if that
conveyance does not have seating or a reception area that is separated
from the narcotic storage and dispensing area. This requirement will be
enforced by the program practitioner and NTP employees.
(k) All NTPs, including mobile NTPs, 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 NTP or
mobile NTP for unsupervised use (e.g., take home or non-directly
observed therapy).
(l) DEA may exercise discretion regarding the degree of security
required in NTPs, including mobile NTPs, based on such factors as the
location of a program, the number of patients enrolled in a program, and
the number of practitioners, staff members, and security guards.
Personnel that are authorized to dispense controlled substances for
narcotic treatment must ensure proper security measures and patient
dosage. Similarly, DEA will consider such factors when evaluating
existing security or requiring new security at a narcotic treatment
program or mobile NTP.
(m) Any controlled substances being transported for disposal from
the dispensing location of a mobile NTP shall be secured and disposed of
in compliance with part 1317, and all other applicable Federal, State,
tribal, and local laws and regulations.
(n) A conveyance used as part of a mobile NTP may only be supplied
with narcotic drugs by the registered NTP that operates such conveyance.
Persons permitted to dispense controlled substances to mobile NTPs shall
not:
[[Page 60]]
(1) Receive controlled substances from other mobile NTPs or any
other entity;
(2) Deliver controlled substances to other mobile NTPs or any other
entity; or
(3) Conduct reverse distribution of controlled substances on a
mobile NTP.
(o) A reverse distributor shall not employ, as an agent or employee
who has access to or influence over controlled substances, any person
who has been convicted of any 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 suspended, or has
surrendered a DEA registration for cause. For purposes of this
subsection, ``for cause'' means 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.
[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.govinfo.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) Sealed mail-back packages and inner liners collected in
accordance with part 1317 of this chapter shall only be stored at the
registered location in a securely locked, substantially constructed
cabinet or a securely locked room with controlled access, except as
authorized by Sec. 1317.80(d).
(d) This section shall also apply to nonpractitioners authorized to
conduct research or chemical analysis under another registration.
(e) Thiafentanil, 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; 79 FR 53562, Sept.
9, 2014; 81 FR 58839, Aug. 26, 2016]
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;
(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
[[Page 61]]
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. Sec.
1301.13(e)(1), 1307.11, 1317.05, and/or 1317.10 of this chapter), he/she
shall comply with the requirements imposed on non-practitioners 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;
79 FR 53562, Sept. 9, 2014]
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:
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.
[[Page 62]]
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.
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.
[[Page 63]]
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 a seal to
disclose upon inspection any tampering or opening of the container.
[62 FR 13958, Mar. 24, 1997]
[[Page 64]]
Sec. 1302.07 Labeling and packaging requirements for imported and
exported substances.
(a) The symbol requirements of Sec. Sec. 1302.03 through 1302.05
apply to every commercial container containing, and to all labeling of,
controlled substances imported into the customs territory of the United
States from any place outside thereof (but within the United States), or
imported into the United States from any place outside thereof.
(b) The symbol requirements of Sec. Sec. 1302.03 through 1302.05 do
not apply to any commercial containers containing, or any labeling of, a
controlled substance intended for export.
(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 the customs
territory of the United States from any place outside thereof (but
within the United States), or imported into the United States from any
place outside thereof. 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, exported or intended
for export from the United States. These sealing and labeling
requirements are in addition to any sealing requirements required under
applicable customs laws.
[81 FR 97020, Dec. 30, 2016]
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.
[[Page 65]]
(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;
(4) Projected demand for such class as indicated by procurement
quotas requested pursuant to Sec. 1303.12;
(5) The extent of any diversion of the controlled substance in the
class;
(6) Relevant information obtained from the Department of Health and
Human Services, including from the Food and Drug Administration, the
Centers for Disease Control and Prevention, and the Centers for Medicare
and Medicaid Services, and relevant information obtained from the
states; and
(7) 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 and
transmitted to each state attorney general. 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, except that the Administrator
shall hold a hearing if he determines it is necessary to resolve an
issue of material fact raised by a state objecting to the proposed
quantity for the class as excessive for legitimate United States' needs.
In the event the Administrator decides to hold 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,
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 and transmitted to each state attorney
general.
[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;
83 FR 32789, July 16, 2018]
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
[[Page 66]]
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. The Administrator may require
additional information from an applicant which, in the Administrator's
judgment, may be helpful in detecting or preventing diversion, including
customer identities and amounts of the controlled substance sold to each
customer.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
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 UN Reporting and Quota
Section, Diversion Control Division. 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 UN Reporting and Quota Section,
Diversion Control Division. 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
[[Page 67]]
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 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.govinfo.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, changes in the rate of net disposal
of the class by registrants holding individual manufacturing quotas for
that class, and changes in the extent of any diversion in the 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
[[Page 68]]
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 and transmitted to each state attorney
general. 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, except that the Administrator shall hold a hearing if he determines
it is necessary to resolve an issue of material fact raised by a state
objecting to the proposed adjusted quota as excessive for legitimate
United States' needs. In the event the Administrator decides to hold 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 person registered
as a bulk manufacturer of the basic class and transmitted to each state
attorney general.
[37 FR 15919, Aug. 8, 1972. Redesignated at 38 FR 26609, Sept. 24, 1973;
83 FR 32790, July 16, 2018]
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. 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; 83 FR32790, July 16, 2018]
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 UN Reporting and Quota Section, Diversion
Control Division. 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;
[[Page 69]]
(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 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.
(d) The Administrator may require additional information from an
applicant which, in the Administrator's judgment, may be helpful in
detecting or preventing diversion, including customer identities and
amounts of the controlled substance sold to each customer.
[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; 81 FR 97020, Dec. 30,
2016; 83 FR 32790, July 16, 2018]
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 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), the extent of any diversion of the controlled substance, 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),
any risk of diversion of the controlled substance, 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; 83 FR 32790, July 16, 2018]
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
[[Page 70]]
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 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
[[Page 71]]
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.
(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, and shall, if
determined by the Administrator to be necessary under Sec. 1303.11(c)
or 1303.13(c) based on objection by a state, 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; 83 FR 32790, July 16, 2018]
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
[[Page 72]]
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 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
[[Page 73]]
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.
Continuing Records
1304.21 General requirements for continuing records.
1304.22 Records for manufacturers, distributors, dispensers,
researchers, importers, exporters, registrants that reverse
distribute, and collectors.
1304.23 Records for chemical analysts.
1304.24 Records for maintenance treatment programs, mobile narcotic
treatment programs, and detoxification treatment programs.
1304.25 Records for treatment programs that 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 Automation of Reports and Consolidated Orders System
(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)-(g), and 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 Sec. 1300.01, Sec.
1300.03, Sec. 1300.04, or Sec. 1300.05 of this chapter.
[81 FR 97020, Dec. 30, 2016]
[[Page 74]]
Sec. 1304.03 Persons required to keep records and file reports.
(a) Every registrant, including collectors, shall maintain the
records and inventories and shall file the reports required by this
part, except as exempted by this section. Any registrant that is
authorized to conduct other activities without being registered to
conduct those activities, pursuant to Sec. Sec. 1301.22(b), 1307.11,
1307.13, or part 1317 of this chapter, shall maintain the records and
inventories and shall file the reports required by this part for persons
registered or authorized 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.
(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
[[Page 75]]
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; 79 FR 53562, Sept. 9, 2014]
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, 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.
(3) A collector that is authorized to maintain a collection
receptacle at a long-term care facility shall keep all records required
by this part relating to those collection receptacles at the registered
location, 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
[[Page 76]]
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,
mobile narcotic treatment program, 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 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
[[Page 77]]
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; 79 FR
53562, Sept. 9, 2014; 86 FR 33885, June 28, 2021]
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]
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.
[[Page 78]]
(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.
(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, registrants that
reverse distribute, importers, exporters, chemical analysts, dispensers,
researchers, and collectors. Each person registered or authorized (by
Sec. Sec. 1301.13, 1307.11, 1307.13, or part 1317 of this chapter) to
manufacture, distribute, reverse distribute, dispense, import, export,
conduct research or chemical analysis with controlled substances, or
collect controlled substances from ultimate users, 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.
[[Page 79]]
(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. 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 registrants that reverse distribute. Each person
registered or authorized to reverse distribute controlled substances
shall include in the inventory, the following information:
(i) The name of the substance, and
(ii) The total quantity of the substance:
(A) For controlled substances in bulk form, to the nearest metric
unit weight consistent with unit size;
(B) For each controlled substance in finished form: Each finished
form of the substance (e.g., 10-milligram tablet or 10-milligram
concentration per fluid ounce or milliliter); the number of units or
volume of each finished form in each commercial container (e.g., 100-
tablet bottle or 3-milliliter vial); and the number of commercial
containers of each such finished form (e.g., four 100-tablet bottles or
six 3-milliliter vials); and
(C) For controlled substances in a commercial container, carton,
crate, drum, or other receptacle that has been opened: If the substance
is listed in Schedule I or II, make an exact count or measure of the
contents; or 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 an exact count
of the contents shall be made; or
(iii) For controlled substances acquired from collectors and law
enforcement: The number and size (e.g., five 10-gallon liners, etc.) of
sealed inner liners on hand, or
(iv) For controlled substances acquired from law enforcement: the
number of sealed mail-back packages on hand.
(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
[[Page 80]]
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.
(6) Inventories of dispensers and researchers. Each person
registered or authorized to dispense or conduct research 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 of a
controlled substance in a commercial container that has been opened, the
dispenser or researcher shall do as follows:
(i) If the substance is listed in Schedules 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.
(7) Inventories of collectors. Each registrant authorized to collect
controlled substances from ultimate users shall include in the inventory
the following information:
(i) For registrants authorized to collect through a mail-back
program, the record shall include the following information about each
unused mail-back package and each returned mail-back package on hand
awaiting destruction:
(A) The date of the inventory;
(B) The number of mail-back packages; and
(C) The unique identification number of each package on hand,
whether unused or awaiting destruction.
(ii) For registrants authorized to collect through a collection
receptacle, the record shall include the following information about
each unused inner liner on hand and each sealed inner liner on hand
awaiting destruction:
(A) The date of the inventory;
(B) The number and size of inner liners (e.g., five 10-gallon
liners, etc.);
(C) The unique identification number of each inner liner.
[62 FR 13959, Mar. 24, 1997, as amended at 68 FR 41228, July 11, 2003;
79 FR 53562, Sept. 9, 2014]
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 substance manufactured, imported, received, sold,
delivered, exported, or otherwise disposed of by him/her, and each inner
liner, sealed inner liner, and unused and returned mail-back package,
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.
[[Page 81]]
(c) Separate records shall be maintained by a registrant for each
independent activity and collection activity for which he/she is
registered or authorized, except as provided in Sec. 1304.22(d).
(d) In recording dates of receipt, distribution, other transfers, or
destruction, the date on which the controlled substances are actually
received, distributed, otherwise transferred, or destroyed will be used
as the date of receipt, distribution, transfer, or destruction (e.g.,
invoices or packing slips, or DEA Form 41). In maintaining records
concerning imports and exports, the registrant must record the
anticipated date of release by a customs official for permit
applications and declarations and the date on which the controlled
substances are released by a customs officer at the port of entry or
port of export for return information.
(e) Record of destruction. In addition to any other recordkeeping
requirements, any registered person that destroys a controlled substance
pursuant to Sec. 1317.95(d), or causes the destruction of a controlled
substance pursuant to Sec. 1317.95(c), shall maintain a record of
destruction on a DEA Form 41. The records shall be complete and
accurate, and include the name and signature of the two employees who
witnessed the destruction. Except, destruction of a controlled substance
dispensed by a practitioner for immediate administration at the
practitioner's registered location, when the substance is not fully
exhausted (e.g., some of the substance remains in a vial, tube, or
syringe after administration but cannot or may not be further utilized),
shall be properly recorded in accordance with Sec. 1304.22(c), and such
record need not be maintained on a DEA Form 41.
[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; 79 FR 53563, Sept. 9, 2014; 81 FR 97020, Dec. 30, 2016]
Sec. 1304.22 Records for manufacturers, distributors, dispensers,
researchers, importers, exporters, registrants that reverse distribute,
and collectors.
Each person registered or authorized (by Sec. Sec. 1301.13(e),
1307.11, 1307.13, or part 1317 of this chapter) to manufacture,
distribute, dispense, import, export, reverse distribute, destroy,
conduct research with controlled substances, or collect controlled
substances from ultimate users, shall maintain records with the
information listed in paragraphs (a) through (f) of this section.
(a) Records for manufacturers. Each person registered or authorized
to manufacture controlled substances shall maintain records with the
following information:
(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
[[Page 82]]
(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;
(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.
[[Page 83]]
(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 registrants that reverse distribute. Each person
registered or authorized to reverse distribute controlled substances
shall maintain records with the following information for each
controlled substance:
(1) For controlled substances acquired for the purpose of return or
recall to the manufacturer or another registrant authorized by the
manufacturer to accept returns on the manufacturer's behalf pursuant to
part 1317 of this chapter:
(i) The date of receipt; the name and quantity of each controlled
substance received; the name, address, and registration number of the
person from whom the substance was received; and the reason for return
(e.g., recall or return); and
(ii) The date of return to the manufacturer or other registrant
authorized by the manufacturer to accept returns on the manufacturer's
behalf; the name and quantity of each controlled substance returned; the
name, address, and registration number of the person from whom the
substance was received; the name, address, and registration number of
the registrant to whom the substance was returned; and the method of
return (e.g., common or contract carrier).
(2) For controlled substances acquired from registrant inventory for
destruction pursuant to Sec. 1317.05(a)(2), (b)(2), and (b)(4) of this
chapter:
(i) The date of receipt; the name and quantity of each controlled
substance received; and the name, address, and registration number of
the person from whom the substance was received; and
(ii) The date, place, and method of destruction; the name and
quantity of each controlled substance destroyed; the name, address, and
registration number of the person from whom the substance was received;
and the name and signatures of the two employees of the registrant that
witnessed the destruction.
(3) The total quantity of each controlled substance shall be
recorded in accordance with the following:
(i) For controlled substances in bulk form: To the nearest metric
unit weight or volume consistent with unit size;
[[Page 84]]
(ii) For controlled substances in finished form: Each finished form
(e.g., 10-milligram tablet or 10-milligram concentration per fluid ounce
or milliliter); the number of units or volume of finished form in each
commercial container (e.g., 100-tablet bottle or 3-milliliter vial); and
the number of commercial containers of each such finished form (e.g.,
four 100-tablet bottles or six 3-milliliter vials); and
(iii) For controlled substances in a commercial container, carton,
crate, drum, or other receptacle that has been opened: If the substance
is listed in Schedule I or II make an exact count or measure of the
contents; or 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 an exact count
of the contents shall be made.
(4) For each sealed inner liner acquired from collectors or law
enforcement and each sealed mail-back package acquired from law
enforcement pursuant to Sec. 1317.55 of this chapter:
(i) The number of sealed inner liners acquired from other persons,
including the date of acquisition, the number and, for sealed inner
liners the size (e.g., five 10-gallon liners, etc.), of all sealed inner
liners and mail-back packages acquired to inventory, the unique
identification number of each sealed inner liner and mail-back package,
and the name, address, and, for registrants, the registration number of
the person from whom the sealed inner liners and mail-back packages were
received, and
(ii) The date, place, and method of destruction; the number of
sealed inner liners and mail-back packages destroyed; the name, address,
and, for registrants, the registration number of the person from whom
the sealed inner liners and mail-back packages were received; the number
and, for sealed inner liners the size (e.g., five 10-gallon liners,
etc.), of all sealed inner liners and mail-back packages destroyed; the
unique identification number of each sealed inner liner and sealed mail-
back package destroyed; and the name and signatures of the two employees
of the registrant that witnessed the destruction.
(5) For all records, the record of receipt shall be maintained
together with the corresponding record of return or destruction (DEA
Form 41).
(f) Records for collectors. Each person registered or authorized to
collect controlled substances from ultimate users shall maintain the
following records:
(1) Mail-Back Packages:
(i) For unused packages that the collector makes available to
ultimate users and other authorized non-registrants at the collector's
registered address: The date made available, the number of packages, and
the unique identification number of each package;
(ii) For unused packages provided to a third party to make available
to ultimate users and other authorized non-registrants: The name of the
third party and physical address of the location receiving the unused
packages, date sent, and the number of unused packages sent with the
corresponding unique identification numbers;
(iii) For sealed mail-back packages received by the collector: Date
of receipt and the unique identification number on the individual
package; and
(iv) For sealed mail-back packages destroyed on-site by the
collector: Number of sealed mail-back packages destroyed, the date and
method of destruction, the unique identification number of each mail-
back package destroyed, and the names and signatures of the two
employees of the registrant who witnessed the destruction.
(2) Collection receptacle inner liners:
(i) Date each unused inner liner acquired, unique identification
number and size (e.g., 5-gallon, 10-gallon, etc.) of each unused inner
liner acquired;
(ii) Date each inner liner is installed, the address of the location
where each inner liner is installed, the unique identification number
and size (e.g., 5-gallon, 10-gallon, etc.) of each installed inner
liner, the registration number of the collector, and the names and
signatures of the two employees that witnessed each installation;
(iii) Date each inner liner is removed and sealed, the address of
the location from which each inner liner is removed, the unique
identification number and size (e.g., 5-gallon, 10-gallon, etc.) of each
inner liner removed, the registration number of the collector,
[[Page 85]]
and the names and signatures of the two employees that witnessed each
removal;
(iv) Date each sealed inner liner is transferred to storage, the
unique identification number and size (e.g., 5-gallon, 10-gallon, etc.)
of each sealed inner liner stored, and the names and signatures of the
two employees that transferred each sealed inner liner to storage;
(v) Date each sealed inner liner is transferred for destruction, the
address and registration number of the reverse distributor or
distributor to whom each sealed inner liner was transferred, the unique
identification number and the size (e.g., 5-gallon, 10-gallon, etc.) of
each sealed inner liner transferred, and the names and signatures of the
two employees that transferred each sealed inner liner to the reverse
distributor or distributor; and
(vi) For sealed inner liners destroyed on-site by the collector: The
same information required of reverse distributors in paragraph
(e)(4)(ii) of this section.
[62 FR 13960, Mar. 24, 1997, as amended at 68 FR 41229, July 11, 2003;
70 FR 293, Jan. 4, 2005; 79 FR 53564, Sept. 9, 2014]
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,
mobile narcotic 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 (NTP), including a mobile NTP, shall maintain
records with the following information for each narcotic controlled
substance:
(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 NTP site, or in the case of a
mobile NTP, at the registered site of the NTP, and will be maintained in
compliance with Sec. 1304.22 without reference to Sec. 1304.03.
(1) As an alternative to maintaining a paper dispensing log, an NTP
or its mobile component may also use an
[[Page 86]]
automated/computerized data processing system for the storage and
retrieval of the program's dispensing records, if the following
conditions are met:
(i) The automated system maintains the information required in
paragraph (a);
(ii) The automated system has the capability of producing a hard
copy printout of the program's dispensing records;
(iii) The NTP or its mobile component prints a hard copy of each
day's dispensing log, which is then initialed appropriately by each
person who dispensed medication to the program's patients;
(iv) The automated system is approved by DEA;
(v) The NTP or its mobile component maintains an off-site back-up of
all computer generated program information; and
(vi) The automated system is capable of producing accurate summary
reports for both the registered site of the NTP and any mobile
component, for any time-frame selected by DEA personnel during an
investigation. If these summary reports are maintained in hard copy
form, they must be kept in a systematically organized file located at
the registered site of the NTP.
(2) The NTP must retain all records for the NTP as well as any
mobile component two years from the date of execution, in accordance
with Sec. 1304.04(a). However, if the State in which the NTP is located
requires that records be retained longer than two years, the NTP should
contact its State opioid treatment authority for information about State
requirements.
(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; 86 FR 33885, June 28, 2021]
Sec. 1304.25 Records for treatment programs that 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;
[[Page 87]]
(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.
(b) For each narcotic controlled substance in finished form:
(1) The name of the substance;
(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, date, and manner of destruction.
[39 FR 37985, Oct. 25, 1974. Redesignated at 62 FR 13961, Mar. 24, 1997;
79 FR 53564, Sept. 9, 2014]
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.
[[Page 88]]
(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 shall be signed by the authorized
official and submitted quarterly on company letterhead to the UN
Reporting and Quota Section, Diversion Control Division, 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
[[Page 89]]
rather as end-product in-process inventories.
[62 FR 13961, Mar. 24, 1997, as amended at 75 FR 10677, Mar. 9, 2010; 81
FR 97020, Dec. 30, 2016]
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 UN
Reporting and Quota Section, Diversion Control Division, 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 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; 81
FR 97020, Dec. 30, 2016]
Sec. 1304.33 Reports to Automation of Reports and Consolidated Orders
System (ARCOS).
(a) Reports generally. All reports required by this section shall be
filed with the Pharmaceutical Investigations Section, Diversion Control
Division, Drug Enforcement Administration on DEA Form 333, or on media
which contains the data required by DEA Form 333 and which is acceptable
to the Administration. See the Table of DEA Mailing Addresses in Sec.
1321.01 of this chapter for the current mailing address.
[[Page 90]]
(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 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. (1) A registered institutional practitioner that
repackages or relabels exclusively for distribution or
[[Page 91]]
that 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
Pharmaceutical Investigations Section, Diversion Control Division, Drug
Enforcement Administration. See the Table of DEA Mailing Addresses in
Sec. 1321.01 of this chapter for the current mailing address.
(2) Registrants that acquire recalled controlled substances from
ultimate users pursuant to Sec. 1317.85 of this chapter may report as a
single transaction all recalled controlled substances of the same name
and finished form (e.g., all 10-milligram tablets or all 5-milligram
concentration per fluid ounce or milliliter) received from ultimate
users for the purpose of reporting acquisition transactions.
(g) Exemptions. (1) Collectors that acquire controlled substances
from ultimate users are exempt from the ARCOS reporting requirements
only with respect to controlled substances collected through mail-back
programs and collection receptacles for the purpose of disposal.
(2) Reverse distributors and distributors that acquire controlled
substances pursuant to Sec. 1317.55(a) or (b) of this chapter are
exempt from the ARCOS reporting requirements in this section with regard
to any controlled substances acquired pursuant to Sec. 1317.55(a) or
(b) of this chapter.
(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; 79 FR 53564, Sept.
9, 2014; 81 FR 97020, Dec. 30, 2016]
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:
(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) It is unlawful for any online pharmacy to deliver, distribute,
or dispense a controlled substance by means of the internet unless such
online pharmacy
[[Page 92]]
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, as amended at 85 FR 61601, Sept. 30, 2020]
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 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
[[Page 93]]
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 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]
[[Page 94]]
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
1305.20 Transition provisions allowing continued use of existing stocks
of triplicate DEA Forms 222.
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.
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.
(e) Deliveries to an authorized DEA registrant by an ultimate user,
a long-term care facility on behalf of an ultimate user who resides or
has resided at that facility, or a person authorized to dispose of the
ultimate user decedent's property.
(f) Distributions to reverse distributors and distributors by
collectors and law enforcement pursuant to Sec. 1317.55 of this
chapter.
(g) Deliveries of controlled substances from ultimate users for the
purpose of recalls pursuant to Sec. 1317.85 of this chapter.
[70 FR 16911, Apr. 1, 2005, as amended at 77 FR 4235, Jan. 27, 2012; 79
FR 53564, Sept. 9, 2014]
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
[[Page 95]]
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. _____________
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:
(1) The registrant, if an individual; a partner of the registrant,
if a partnership; or an officer of the registrant, if a corporation,
corporate division, association, trust or other entity;
(2) The person to whom the power of attorney is being granted; and
(3) 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.
[[Page 96]]
(f) A power of attorney executed under this section may be signed
electronically, by any or all of the persons required to sign.
[70 FR 16911, Apr. 1, 2005, as amended at 84 FR 51374, Sept. 30, 2019]
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 thiafentanil, 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 thiafentanil,
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 the content, only to the purchaser's registered location.
[70 FR 16911, Apr. 1, 2005, as amended at 81 FR 58839, Aug. 26, 2016]
Subpart B_DEA Form 222
Sec. 1305.11 Procedure for obtaining DEA Forms 222.
(a) DEA Forms 222 are issued in mailing envelopes containing a
predetermined number of forms based on the business activity of the
registrant, each form consisting of one single-sheet. A limit, which is
based on the business activity of the registrant, will be imposed on the
number of DEA Forms 222 that will be furnished upon a requisition for
order forms unless additional forms are specifically requested and a
reasonable need for such additional forms is shown.
(b) Any person with an active registration that is authorized to
order schedule I and II controlled substances is entitled to obtain a
DEA Form 222, which will be supplied at any time after the DEA
registration is granted.
[[Page 97]]
Any person holding a registration authorizing the person to obtain a DEA
Form 222 may requisition the forms through a DEA secured network
connection or by contacting any Division Office or the Registration
Section of the Administration through the customer service center.
(c) Each requisition must show the name, address, and registration
number of the registrant and the number of DEA Forms 222 desired.
(d) DEA Forms 222 will have an order form number and be 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; the registrant must
report any errors to the local Division Office or the Registration
Section of the Administration to modify the registration.
[84 FR 51374, Sept. 30, 2019]
Sec. 1305.12 Procedure for executing DEA Forms 222.
(a) A purchaser must prepare and execute a DEA Form 222 by use of a
typewriter, computer printer, 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. The supplier's DEA registration
number may be entered by the purchaser or the supplier.
(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.
[70 FR 16911, Apr. 1, 2005, as amended at 84 FR 51374, Sept. 30, 2019;
86 FR 38232, July 20, 2021]
Sec. 1305.13 Procedure for filling DEA Forms 222.
(a) A purchaser must make a copy of the original DEA Form 222 for
its records and then submit the original to the supplier. The copy
retained by the purchaser may be in paper or electronic form.
(b) A supplier may fill the order, if possible and if the supplier
desires to do so, and must record on the original DEA Form 222 its DEA
registration number (if not previously entered by the purchaser) and the
number of commercial or bulk containers furnished on each item and the
date on which 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 the original DEA Form 222 for the
supplier's files in accordance with Sec. 1305.17(c). Any supplier who
is not required to report acquisition/disposition transactions to the
Automation of Reports and Consolidated Orders System (ARCOS) under Sec.
1304.33(c) (such as a practitioner) must make and submit a copy of the
original DEA Form 222 to
[[Page 98]]
DEA, either by mail to the Registration Section, or by email to
[email protected]. The copy must be forwarded at the close of the
month during which the order is filled. If an order is filled by partial
shipments, the copy 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 its copy 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.
[70 FR 16911, Apr. 1, 2005, as amended at 84 FR 51374, Sept. 30, 2019;
86 FR 38232, July 20, 2021]
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 in Part 3 on the
original DEA Form 222) the DEA number of the second supplier, and must
be signed and dated 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.
[70 FR 16911, Apr. 1, 2005, as amended at 84 FR 51375, Sept. 30, 2019]
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 the original DEA Form 222 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, the original DEA
Form 222 and the statement must be 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.
[70 FR 16911, Apr. 1, 2005, as amended at 84 FR 51375, Sept. 30, 2019]
Sec. 1305.16 Lost and stolen DEA Forms 222.
(a) If a purchaser ascertains that an unfilled DEA Form 222 has been
lost, the purchaser must execute another and attach a statement
containing the order form 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. A copy of the second form and a copy
of the statement must be retained with a copy of the DEA Form 222 first
executed. A copy of the statement must be attached to a copy 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 the
original DEA Form
[[Page 99]]
222 to the purchaser, who must attach it to 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 any DEA Forms 222 are lost or stolen, and the purchaser is
unable to state the order form numbers of the DEA Forms 222, the
purchaser must report, in lieu of numbers of the forms, 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.
[70 FR 16911, Apr. 1, 2005, as amended at 84 FR 51375, Sept. 30, 2019]
Sec. 1305.17 Preservation of DEA Forms 222.
(a) The purchaser must retain a copy of each executed DEA Form 222
and all copies of unaccepted or defective forms with each statement
attached.
(b) The supplier must retain the original 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 a copy 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 thiafentanil, 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.
(e) Electronic copies of DEA Forms 222 will be deemed to be
maintained separately from all other records of the registrant, for the
purposes of this section, if such copies are readily retrievable
separately from all other records. Electronic copies of DEA Forms 222
may be stored on a system at a location different from the registered
location, provided such copies are readily retrievable at the registered
location.
[70 FR 16911, Apr. 1, 2005, as amended at 81 FR 58839, Aug. 26, 2016; 84
FR 51375, Sept. 30, 2019]
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 Registration Section.
[84 FR 51375, Sept. 30, 2019]
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 the original DEA Form 222 sent by the
purchaser by drawing a line through the canceled items and printing
``canceled'' in the space provided for the 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
[[Page 100]]
voiding in the manner prescribed for cancellation in paragraph (a) of
this section.
[70 FR 16911, Apr. 1, 2005, as amended at 84 FR 51375, Sept. 30, 2019]
Sec. 1305.20 Transition provisions allowing continued use of existing
stocks of triplicate DEA Forms 222.
Registrants may continue to use existing stocks of the triplicate
DEA Form 222 until October 30, 2021. In any case, as soon as a
registrant's supply of triplicate DEA Forms 222 is exhausted, the
registrant must use the new single-sheet DEA Form 222. The provisions of
this part are applicable to the use of triplicate forms, except for the
specific rules as provided in this section.
(a) Procedure for obtaining triplicate DEA Forms 222. The DEA will
no longer issue triplicate forms. Triplicate DEA Forms 222 will not be
accepted after October 30, 2021.
(b) Procedure for executing triplicate DEA Forms 222. (1) A
purchaser must prepare and execute a triplicate DEA Form 222
simultaneously by means of interleaved carbon sheets that are part of
the triplicate DEA Form 222. Triplicate DEA Form 222 must be prepared by
use of a typewriter, pen, or indelible pencil.
(2) 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. Triplicate DEA Forms 222 for carfentanil, etorphine
hydrochloride, and diprenorphine must contain only these substances.
(3) 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.
(4) Each triplicate 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 DEA 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.
(5) 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.
(c) Procedure for filling triplicate DEA Forms 222. (1) A purchaser
must submit Copy 1 and Copy 2 of the triplicate DEA Form 222 to the
supplier and retain Copy 3 in the purchaser's files.
(2) 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 triplicate DEA Form 222. No triplicate DEA Form 222 is valid more
than 60 days after its execution by the purchaser, except as specified
in paragraph (c)(6) of this section.
(3) The controlled substances must be shipped only to the purchaser
and the location printed by the Administration on the triplicate DEA
Form 222, except as specified in paragraph (c)(6) of this section.
(4) The supplier must retain Copy 1 of the triplicate DEA Form 222
for his or her files in accordance with paragraph (g)(3) of this section
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.
(5) The purchaser must record on Copy 3 of the triplicate 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.
[[Page 101]]
(6) DEA triplicate 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
triplicate 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.
(d) Procedure for endorsing triplicate DEA Forms 222. (1) A
triplicate 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 paragraph
(c) of this section, may be endorsed to another supplier for filling.
The endorsement must be made only by the supplier to whom the triplicate
DEA Form 222 was first made, must state (in the spaces provided on the
reverse sides of Copies 1 and 2 of the triplicate DEA Form 222) the name
and address of the second supplier, and must be signed by a person
authorized to obtain and execute triplicate 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 paragraphs
(c)(2) through (4) of this section, including shipping all substances
directly to the purchaser.
(2) Distributions made on endorsed triplicate DEA Forms 222 must be
reported by the second supplier in the same manner as all other
distributions.
(e) Unaccepted and defective triplicate DEA Forms 222. (1) A
triplicate DEA Form 222 must not be filled if either of the following
apply:
(i) The order is not complete, legible, or properly prepared,
executed, or endorsed.
(ii) The order shows any alteration, erasure, or change of any
description.
(2) If a triplicate 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).
(3) 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.
(4) When a purchaser receives an unaccepted order, Copies 1 and 2 of
the triplicate DEA Form 222 and the statement must be attached to Copy 3
and retained in the files of the purchaser in accordance with paragraph
(g) of this section. A defective triplicate DEA Form 222 may not be
corrected; it must be replaced by a new triplicate DEA Form 222 for the
order to be filled.
(f) Lost and stolen triplicate DEA Forms 222. (1) If a purchaser
ascertains that an unfilled triplicate DEA Form 222 has been lost, the
purchaser 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 triplicate DEA Form 222 were not received
through loss of that triplicate DEA Form 222. Copy 3 of the second form
and a copy of the statement must be retained with Copy 3 of the
triplicate DEA Form 222 first executed. A copy of the statement must be
attached to Copies 1 and 2 of the second triplicate DEA Form 222 sent to
the supplier. If the first triplicate 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. However, if
the registrant no longer can use triplicate forms, then the registrant
shall proceed by issuing a new single-sheet form in accordance with
Sec. 1305.16.
(2) Whenever any used or unused triplicate 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.
[[Page 102]]
(3) If the theft or loss includes any original triplicate DEA Forms
222 received from purchasers and the supplier is unable to state the
serial numbers of the triplicate DEA Forms 222, the supplier must report
the date or approximate date of receipt and the names and addresses of
the purchasers.
(4) If an entire book of triplicate DEA Forms 222 is lost or stolen,
and the purchaser is unable to state the serial numbers of the
triplicate 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.
(5) If any unused triplicate 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.
(g) Preservation of triplicate DEA Forms 222. (1) The purchaser must
retain Copy 3 of each executed triplicate DEA Form 222 and all copies of
unaccepted or defective forms with each statement attached.
(2) The supplier must retain Copy 1 of each triplicate DEA Form 222
that it has filled.
(3) Triplicate DEA Forms 222 must be maintained separately from all
other records of the registrant. Triplicate 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 triplicate DEA Form 222 and any attached
statements or other related documents (not including unexecuted
triplicate DEA Forms 222, which may be kept elsewhere under paragraph
(b)(5) of this section), at the registered location printed on the
triplicate DEA Form 222.
(4) The supplier of thiafentanil, carfentanil, etorphine
hydrochloride, and diprenorphine must maintain triplicate DEA Forms 222
for these substances separately from all other DEA triplicate Forms 222
and records required to be maintained by the registrant.
(h) Return of unused triplicate 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 triplicate DEA Forms
222 to the Registration Section.
(i) Cancellation and voiding of triplicate DEA Forms 222. (1) A
purchaser may cancel part or all of an order on a triplicate 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
triplicate DEA Form 222 by drawing a line through the canceled items and
printing ``canceled'' in the space provided for the number of items
shipped.
(2) A supplier may void part or all of an order on a triplicate 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 (i)(1) of this section.
[84 FR 51375, Sept. 30, 2019]
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).
[[Page 103]]
(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.
(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.
[[Page 104]]
(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.
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.
[[Page 105]]
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, 823, 829, 829a, 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
(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
[[Page 106]]
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.
(d) A prescription may be issued by a qualifying practitioner, as
defined in section 303(g)(2)G)(iii) of the Act (21 U.S.C.
823(g)(2)(G)(iii), in accordance with Sec. 1306.05 for a Schedule III,
IV, or V controlled substance for the purpose of maintenance or
detoxification treatment for the purposes of administration in
accordance with section 309A of the Act (21 U.S.C. 829a) and Sec.
1306.07(f). Such prescription issued by a qualifying practitioner shall
not be used to supply any practitioner with a stock of controlled
substances for the purpose of general dispensing to patients.
[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;
85 FR 69167, Nov. 2, 2020]
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 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
[[Page 107]]
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.
(e) [Reserved]
(f) Notwithstanding the definition of dispense under section 102(10)
of the Act (21 U.S.C 802(10)), a pharmacy may deliver a controlled
substance to a practitioner, pursuant to a prescription that meets the
requirements under Sec. 1306.04 for the purpose of administering the
controlled substance by the practitioner if:
(1) The controlled substance is delivered by the pharmacy to the
prescribing practitioner or the practitioner administering the
controlled substance, as applicable, at the location, listed on the
practitioner's certificate of registration;
(2) The controlled substance is to be administered for the purpose
of maintenance or detoxification treatment under section
303(g)(2)(G)(iii) of the Act (21 U.S.C. 823(g)(2)(G)(iii)); and
(i) The practitioner who issued the prescription is a qualifying
practitioner as defined in section 303(g) of the Act (21 U.S.C. 823(g));
and
(ii) The controlled substance is to be administered by injection or
implantation;
(3) The pharmacy and the practitioner are authorized to conduct such
activities specified in this paragraph (f) under the law of the State in
which such activities take place;
(4) The prescription is not issued to supply any practitioner with a
stock of controlled substances for the purpose of general dispensing to
patients;
(5) The controlled substance is to be administered only to the
patient named on the prescription not later than 14 days after the date
of receipt of the controlled substance by the practitioner; and
(6) Notwithstanding any exceptions under section 307 of the Act (21
U.S.C. 827), the prescribing practitioner, and
[[Page 108]]
the practitioner administering the controlled substance, as applicable,
shall maintain complete and accurate records of all controlled
substances delivered, received, administered, or otherwise disposed of,
under this paragraph (f), including the persons to whom the controlled
substances were delivered and such other information as may be required
under this chapter.
[39 FR 37986, Oct. 25, 1974, as amended at 70 FR 36344, June 23, 2005;
85 FR 69167, Nov. 2, 2020]
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 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
[[Page 109]]
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 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
[[Page 110]]
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;
(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
[[Page 111]]
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.
(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]
[[Page 112]]
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 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
[[Page 113]]
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.
(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
[[Page 114]]
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 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
[[Page 115]]
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 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
[[Page 116]]
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.
(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
[[Page 117]]
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 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.
1307.13 Incidental manufacture of controlled substances.
Disposal of Controlled Substances
1307.22 Delivery of surrendered and forfeited controlled substances.
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
[[Page 118]]
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 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.
(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) [Reserved]
(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; 79
FR 53565, Sept. 9, 2014]
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
[[Page 119]]
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 part 1317 of this chapter.
[79 FR 53565, Sept. 9, 2014]
Disposal of Controlled Substances
Sec. 1307.22 Delivery of surrendered and forfeited controlled substances.
Any controlled substance surrendered by delivery to the
Administration under part 1317 of this chapter 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 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, as amended at 79 FR 53565, Sept. 9, 2014]
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 this part.
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 Temporary scheduling.
[[Page 120]]
Authority: 21 U.S.C. 811, 812, 871(b), 956(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 this part.
Schedules of controlled substances established by section 202 of the
Act (21 U.S.C. 812) and nonnarcotic substances, chemical preparations,
veterinary anabolic steroid implant products, prescription products,
anabolic steroid products, and cannabis plant material and products made
therefrom that contain tetrahydrocannabinols excluded pursuant to
section 201 of the Act (21 U.S.C. 811), as they are changed, updated,
and republished from time to time, are set forth in this part.
[81 FR 97021, Dec. 30, 2016]
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]
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 3-
methylthiofentanyl only, the term isomer includes the optical and
geometric isomers):
(1) Acetyl-alpha-methylfentanyl (N-[1-(1-methyl-2-phenethyl)- 9815
4-piperidinyl]-N-phenylacetamide)...........................
(2) Acetylmethadol........................................... 9601
(3) Acetyl fentanyl (N-(1-phenethylpiperidin-4-yl)-N- 9821
phenylacetamide)............................................
(4) Acryl fentanyl (N-(1-phenethylpiperidin-4-yl)-N- 9811
phenylacrylamide; also known as acryloylfentanyl)...........
(5) AH-7921 (3,4-dichloro-N-[(1- 9551
dimethylamino)cyclohexylmethyl]benzamide)...................
[[Page 121]]
(6) Allylprodine............................................. 9602
(7) Alphacetylmethadol (except levo-alphacetylmethadol also 9603
known as levo-alpha-acetylmethadol, levomethadyl acetate, or
LAAM).......................................................
(8) Alphameprodine........................................... 9604
(9) Alphamethadol............................................ 9605
(10) alpha-Methylfentanyl (N-[1-(alpha-methyl-beta- 9814
phenyl)ethyl-4-piperidyl]propionanilide; 1-(1-methyl-2-
phenylethyl)-4-(N-propanilido)piperidine)...................
(11) alpha-Methylthiofentanyl (N-[1-methyl-2-(2-thienyl)ethyl- 9832
4-piperidinyl]-N-phenylpropanamide).........................
(12) Benzethidine............................................ 9606
(13) Betacetylmethadol....................................... 9607
(14) beta-Hydroxyfentanyl (N-[1-(2-hydroxy-2-phenethyl)-4- 9830
piperidinyl]-N-phenylpropanamide)...........................
(15) beta-Hydroxy-3-methylfentanyl (N-[1-(2-hydroxy-2- 9831
phenylethyl)-3-methyl-4-piperidinyl]-N-phenylpropanamide)...
(16) beta-Hydroxythiofentanyl (N-[1-[2-hydroxy-2-(thiophen-2- 9836
yl)ethyl]piperidin-4-yl]-N-phenylpropionamide)..............
(17) Betameprodine........................................... 9608
(18) Betamethadol............................................ 9609
(19) beta-Methyl fentanyl (N-phenyl-N-(1-(2- 9856
phenylpropyl)piperidin-4-yl)propionamide; also known as
[beta]-methyl fentanyl).....................................
(20) beta[min]-Phenyl fentanyl (N-(1-phenethylpiperidin-4-yl)- 9842
N,3-diphenylpropanamide; also known as [beta][min]-phenyl
fentanyl; 3-phenylpropanoyl fentanyl).......................
(21) Betaprodine............................................. 9611
(22) Butyryl fentanyl (N-(1-phenethylpiperidin-4-yl)-N- 9822
phenylbutyramide)...........................................
(23) Clonitazene............................................. 9612
(24) Crotonyl fentanyl ((E)-N-(1-phenethylpiperidin-4-yl)-N- 9844
phenylbut-2-enamide)........................................
(25) Cyclopentyl fentanyl (N-(1-phenethylpiperidin-4-yl)-N- 9847
phenylcyclopentanecarboxamide)..............................
(26) Cyclopropyl fentanyl (N-(1-phenethylpiperidin-4-yl)-N- 9845
phenylcyclopropanecarboxamide)..............................
(27) Dextromoramide.......................................... 9613
(28) Diampromide............................................. 9615
(29) Diethylthiambutene...................................... 9616
(30) Difenoxin............................................... 9168
(31) Dimenoxadol............................................. 9617
(32) Dimepheptanol........................................... 9618
(33) Dimethylthiambutene..................................... 9619
(34) Dioxaphetyl butyrate.................................... 9621
(35) Dipipanone.............................................. 9622
(36) Ethylmethylthiambutene.................................. 9623
(37) Etonitazene............................................. 9624
(38) Etoxeridine............................................. 9625
(39) Fentanyl carbamate (ethyl (1-phenethylpiperidin-4- 9851
yl)(phenyl)carbamate).......................................
(40) 4-Fluoroisobutyryl fentanyl (N-(4-fluorophenyl)-N-(1- 9824
phenethylpiperidin-4-yl)isobutyramide; also known as para-
fluoroisobutyryl fentanyl)..................................
(41) 2[min]-Fluoro ortho-fluorofentanyl (N-(1-(2- 9855
fluorophenethyl)piperidin-4-yl)-N-(2-
fluorophenyl)propionamide; also known as 2[min]-fluoro 2-
fluorofentanyl).............................................
(42) Furanyl fentanyl (N-(1-phenethylpiperidin-4-yl)-N- 9834
phenylfuran-2-carboxamide)..................................
(43) Furethidine............................................. 9626
(44) Hydroxypethidine........................................ 9627
[[Page 122]]
(45) Isobutyryl fentanyl (N-(1-phenethylpiperidin-4-yl)-N- 9827
phenylisobutyramide)........................................
(46) Isotonitazene (N,N-diethyl-2-(2-(4-isopropoxybenzyl)-5- 9614
nitro-1H-benzimidazol-1-yl)ethan-1-amine)...................
(47) Ketobemidone............................................ 9628
(48) Levomoramide............................................ 9629
(49) Levophenacylmorphan..................................... 9631
(50) Methoxyacetyl fentanyl (2-methoxy-N-(1- 9825
phenethylpiperidin-4-yl)-N-phenylacetamide).................
(51) 4[min]-Methyl acetyl fentanyl (N-(1-(4- 9819
methylphenethyl)piperidin-4-yl)-N-phenylacetamide)..........
(52) 3-Methylfentanyl (N-[3-methyl-1-(2-phenylethyl)-4- 9813
piperidyl]-N-phenylpropanamide).............................
(53) 3-Methylthiofentanyl (N-[3-methyl-1-(2-thienylethyl)-4- 9833
piperidinyl]-N-phenylpropanamide)...........................
(54) Morpheridine............................................ 9632
(55) MPPP (1-methyl-4-phenyl-4-propionoxypiperidine)......... 9661
(56) MT-45 (1-cyclohexyl-4-(1,2-diphenylethyl)piperazine).... 9560
(57) Noracymethadol.......................................... 9633
(58) Norlevorphanol.......................................... 9634
(59) Normethadone............................................ 9635
(60) Norpipanone............................................. 9636
(61) Ocfentanil (N-(2-fluorophenyl)-2-methoxy-N-(1- 9838
phenethylpiperidin-4-yl)acetamide)..........................
(62) ortho-Fluoroacryl fentanyl (N-(2-fluorophenyl)-N-(1- 9852
phenethylpiperidin-4-yl)acrylamide).........................
(63) ortho-Fluorobutyryl fentanyl (N-(2-fluorophenyl)-N-(1- 9846
phenethylpiperidin-4-yl)butyramide; also known as 2-
fluorobutyryl fentanyl).....................................
(64) ortho-Fluorofentanyl (N-(2-fluorophenyl)-N-(1- 9816
phenethylpiperidin-4-yl)propionamide); also known as 2-
fluorofentanyl).............................................
(65) ortho-Fluoroisobutyryl fentanyl (N-(2-fluorophenyl)-N-(1- 9853
phenethylpiperidin-4-yl)isobutyramide)......................
(66) ortho-Methyl acetylfentanyl (N-(2-methylphenyl)-N-(1- 9848
phenethylpiperidin-4-yl)acetamide; also known as 2-methyl
acetylfentanyl).............................................
(67) ortho-Methyl methoxyacetyl fentanyl (2-methoxy-N-(2- 9820
methylphenyl)-N-(1-phenethylpiperidin-4-yl)acetamide; also
known as 2-methyl methoxyacetyl fentanyl)...................
(68) para-Chloroisobutyryl fentanyl (N-(4-chlorophenyl)-N-(1- 9826
phenethylpiperidin-4-yl)isobutyramide)......................
(69) para-Fluorobutyryl fentanyl (N-(4-fluorophenyl)-N-(1- 9823
phenethylpiperidin-4-yl)butyramide).........................
(70) para-Fluorofentanyl (N-(4-fluorophenyl)-N-[1-(2- 9812
phenylethyl)-4-piperidinyl]propanamide).....................
(71) para-Fluoro furanyl fentanyl (N-(4-fluorophenyl)-N-(1- 9854
phenethylpiperidin-4-yl)furan-2-carboxamide)................
(72) para-Methoxybutyryl fentanyl (N-(4-methoxyphenyl)-N-(1- 9837
phenethylpiperidin-4-yl)butyramide).........................
(73) para-Methylfentanyl (N-(4-methylphenyl)-N-(1- 9817
phenethylpiperidin-4-yl)propionamide; also known as 4-
methylfentanyl).............................................
(74) PEPAP (1-(2-phenylethyl)-4-phenyl-4-acetoxypiperidine).. 9663
(75) Phenadoxone............................................. 9637
(76) Phenampromide........................................... 9638
(77) Phenomorphan............................................ 9647
(78) Phenoperidine........................................... 9641
(79) Phenyl fentanyl (N-(1-phenethylpiperidin-4-yl)-N- 9841
phenylbenzamide; also known as benzoyl fentanyl)............
(80) Piritramide............................................. 9642
[[Page 123]]
(81) Proheptazine............................................ 9643
(82) Properidine............................................. 9644
(83) Propiram................................................ 9649
(84) Racemoramide............................................ 9645
(85) Tetrahydrofuranyl fentanyl (N-(1-phenethylpiperidin-4- 9843
yl)-N-phenyltetrahydrofuran-2-carboxamide)..................
(86) Thiofentanyl (N-phenyl-N-[1-(2-thienyl)ethyl-4- 9835
piperidinyl]propanamide)....................................
(87) Thiofuranyl fentanyl (N-(1-phenethylpiperidin-4-yl)-N- 9839
phenylthiophene-2-carboxamide; also known as 2-thiofuranyl
fentanyl; thiophene fentanyl)...............................
(88) Tilidine................................................ 9750
(89) Trimeperidine........................................... 9646
(90) U-47700 (3,4-dichloro-N-[2-(dimethylamino)cyclohexyl]-N- 9547
methylbenzamide)............................................
(91) Valeryl fentanyl (N-(1-phenethylpiperidin-4-yl)-N- 9840
phenylpentanamide)..........................................
(92) Zipeprol (1-methoxy-3-[4-(2-methoxy-2- 9873
phenylethyl)piperazin-1-yl]-1-phenylpropan-2-ol)............
(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 124]]
Some trade or other names: DOET
(6) 2,5-dimethoxy-4-(n)-propylthiophenethylamine (other name: 7348
2C-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 7431
names: 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
[[Page 125]]
(31) Tetrahydrocannabinols..................................... 7370
(i) Meaning tetrahydrocannabinols, except as in paragraph
(d)(31)(ii) of this section, 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.)
(ii) Tetrahydrocannabinols does not include any material,
compound, mixture, or preparation that falls within the
definition of hemp set forth in 7 U.S.C. 1639o.
(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
(48) (1-pentyl-1H-indol-3-yl)(2,2,3,3- (7144)
tetramethylcyclopropyl)methanone (UR-144).....................
(49) [1-(5-fluoro-pentyl)-1H-indol-3-yl](2,2,3,3- (7011)
tetramethylcyclopropyl)methanone (5-fluoro-UR-144, XLR11).....
[[Page 126]]
(50) N-(1-adamantyl)-1-pentyl-1H-indazole-3-carboxamide (7048)
(APINACA, AKB48)..............................................
(51) quinolin-8-yl 1-pentyl-1H-indole-3-carboxylate (PB-22; (7222)
QUPIC)........................................................
(52) quinolin-8-yl 1-(5-fluoropentyl)-1H-indole-3-carboxylate (7225)
(5-fluoro-PB-22; 5F-PB-22)....................................
(53) N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-(4-fluorobenzyl)-1H- (7012)
indazole-3-carboxamide (AB-FUBINACA)..........................
(54) N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-pentyl-1H- (7035)
indazole-3-carboxamide (ADB-PINACA)...........................
(55) 2-(4-iodo-2,5-dimethoxyphenyl)-N-(2- (7538)
methoxybenzyl)ethanamine (25I-NBOMe, 2C-I-NBOMe)..............
(56) 2-(4-chloro-2,5-dimethoxyphenyl)-N-(2- (7537)
methoxybenzyl)ethanamine (25C-NBOMe, 2C-C-NBOMe)..............
(57) 2-(4-bromo-2,5-dimethoxyphenyl)-N-(2- (7536)
methoxybenzyl)ethanamine (25B-NBOMe, 2C-B-NBOMe)..............
(58) Marihuana Extract......................................... 7350
Meaning an extract containing one or more cannabinoids that
has been derived from any plant of the genus Cannabis,
containing greater than 0.3% delta-9-tetrahydrocannabinol on
a dry weight basis, other than the separated resin (whether
crude or purified) obtained from the plant.
(59) 4-methyl-N-ethylcathinone (4-MEC)......................... (1249)
(60) 4-methyl-alpha-pyrrolidinopropiophenone (4-MePPP)......... (7498)
(61) alpha-pyrrolidinopentiophenone ([alpha]-PVP).............. (7545)
(62) 1-(1,3-benzodioxol-5-yl)-2-(methylamino)butan-1-one (7541)
(butylone, bk-MBDB)...........................................
(63) 2-(methylamino)-1-phenylpentan-1-one (pentedrone)......... (1246)
(64) 1-(1,3-benzodioxol-5-yl)-2-(methylamino)pentan-1-one (7542)
(pentylone, bk-MBDP)..........................................
(65) 4-fluoro-N-methylcathinone (4-FMC; flephedrone)........... (1238)
(66) 3-fluoro-N-methylcathinone (3-FMC)........................ (1233)
(67) 1-(naphthalen-2-yl)-2-(pyrrolidin-1-yl)pentan-1-one (1258)
(naphyrone)...................................................
(68) alpha-pyrrolidinobutiophenone ([alpha]-PBP)............... (7546)
(69) N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-(cyclohexylmethyl)- (7031)
1H-indazole-3-carboxamide (AB-CHMINACA).......................
(70) N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-pentyl-1H-indazole- (7023)
3-carboxamide (AB-PINACA).....................................
(71) [1-(5-fluoropentyl)-1H-indazol-3-yl](naphthalen-1- (7024)
yl)methanone (THJ-2201).......................................
(72) N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1- (7032)
(cyclohexylmethyl)-1H-indazole-3-carboxamide (MAB-CHMINACA;
ADB-CHMINACA).................................................
(73) methyl 2-(1-(5-fluoropentyl)-1H-indazole-3-carboxamido)- 7034
3,3-dimethylbutanoate (Other names: 5F-ADB; 5F-MDMB-PINACA)...
(74) methyl 2-(1-(5-fluoropentyl)-1H-indazole-3-carboxamido)-3- 7033
methylbutanoate (Other names: 5F-AMB).........................
(75) N-(adamantan-1-yl)-1-(5-fluoropentyl)-1H-indazole-3- 7049
carboxamide (Other names: 5F-APINACA, 5F-AKB48)...............
(76) N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-(4- 7010
fluorobenzyl)-1H-indazole-3-carboxamide (Other names: ADB-
FUBINACA).....................................................
[[Page 127]]
(77) methyl 2-(1-(cyclohexylmethyl)-1H-indole-3-carboxamido)- 7042
3,3-dimethylbutanoate (Other names: MDMB-CHMICA, MMB-CHMINACA)
(78) methyl 2-(1-(4-fluorobenzyl)-1H-indazole-3-carboxamido)- 7020
3,3-dimethylbutanoate (Other names: MDMB-FUBINACA)............
(79) methyl 2-(1-(4-fluorobenzyl)-1H-indazole-3-carboxamido)-3- (7021)
methylbutanoate, (FUB-AMB, MMB-FUBINACA, AMB-FUBINACA)........
(80) 1-(1,3-benzodioxol-5-yl)-2-(ethylamino)propan-1-one 7547
(ethylone)....................................................
(81) Naphthalen-1-yl 1-(5-fluoropentyl)-1H-indole-3-carboxylate 7221
(Other names: NM2201; CBL2201)................................
(82) N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-(5-fluoropentyl)-1H- 7025
indazole-3-carboxamide (Other name: 5F-AB-PINACA).............
(83) 1-(4-cyanobutyl)-N-(2-phenylpropan-2-yl)-1H-indazole-3- 7089
carboxamide (Other names: 4-CN-CUMYL-BUTINACA; 4-cyano-CUMYL-
BUTINACA; 4-CN-CUMYL BINACA; CUMYL-4CN-BINACA; SGT-78)........
(84) methyl 2-(1-(cyclohexylmethyl)-1H-indole-3-carboxamido)-3- 7044
methylbutanoate (Other names: MMB-CHMICA; AMB-CHMICA).........
(85) 1-(5-fluoropentyl)-N-(2-phenylpropan-2-yl)-1H-pyrrolo[2,3- 7085
b]pyridine-3-carboxamide (Other name: 5F-CUMYL-P7AICA)........
(86) N-ethylpentylone (Other names: ephylone, 1-(1,3- 7543
benzodioxol-5-yl)-2-(ethylamino)pentan-1-one).................
(87) methyl 2-(1-(4-fluorobutyl)-1H-indazole-3-carboxamido)-3,3- 7043
dimethylbutanoate (4F-MDMB-BINACA, 4F-MDMB-BUTINACA)..........
(88) 1-(4-methoxyphenyl)-N-methylpropan-2-amine (other names: (1245)
para-methoxymethamphetamine, PMMA)............................
(89) ethyl 2-(1-(5-fluoropentyl)-1H-indazole-3-carboxamido)-3,3- 7036
dimethylbutanoate (other name: 5F-EDMB-PINACA)................
(90) methyl 2-(1-(5-fluoropentyl)-1H-indole-3-carboxamido)-3,3- 7041
dimethylbutanoate (other names: 5F-MDMB-PICA; 5F-MDMB-2201)...
(91) N-(adamantan-1-yl)-1-(4-fluorobenzyl)-1H-indazole-3- 7047
carboxamide (other names: FUB-AKB48; FUB-APINACA; AKB48 N-(4-
FLUOROBENZYL))................................................
(92) 1-(5-fluoropentyl)-N-(2-phenylpropan-2-yl)-1H-indazole-3- 7083
carboxamide (other names: 5F-CUMYL-PINACA; SGT-25)............
(93) (1-(4-fluorobenzyl)-1H-indol-3-yl)(2,2,3,3- 7014
tetramethylcyclopropyl)methanone (other name: FUB-144)........
(94) N-Ethylhexedrone (Other names: [alpha]- 7246
ethylaminohexanophenone; 2-(ethylamino)-1-phenylhexan-1-one)..
(95) alpha-Pyrrolidinohexanophenone (Other names: [alpha]-PHP; 7544
[alpha]-pyrrolidinohexanophenone; 1-phenyl-2-(pyrrolidin-1-
yl)hexan-1-one)...............................................
(96) 4-Methyl-alpha-ethylaminopentiophenone (Other names: 4- 7245
MEAP; 2-(ethylamino)-1-(4-methylphenyl)pentan-1-one)..........
(97) 4[min]-Methyl-alpha-pyrrolidinohexiophenone (Other names: 7446
MPHP; 4[min]-methyl-alpha-pyrrolidinohexanophenone; 1-(4-
methylphenyl)-2-(pyrrolidin-1-yl)hexan-1-one).................
(98) alpha-Pyrrolidinoheptaphenone (Other names: PV8; 1-phenyl- 7548
2-(pyrrolidin-1-yl)heptan-1-one)..............................
[[Page 128]]
(99) 4[min]-Chloro-alpha-pyrrolidinovalerophenone (Other names: 7443
4-chloro-[alpha]-PVP; 4[min]-chloro-[alpha]-
pyrrolidinopentiophenone; 1-(4-chlorophenyl)-2-(pyrrolidin-1-
yl)pentan-1-one)..............................................
(100) 2-(ethylamino)-2-(3-methoxyphenyl)cyclohexan-1-one 7286
(methoxetamine, MXE)..........................................
(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 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) Amineptine (7-[(10,11-dihydro-5H-dibenzo[a,d]cyclohepten-5- 1219
yl)amino]heptanoic acid)......................................
(2) Aminorex (Some other names: aminoxaphen; 2-amino-5-phenyl-2- 1585
oxazoline; or 4,5-dihydro-5-phenly-2-oxazolamine).............
(3) N-Benzylpiperazine (some other names: BZP, 1- 7493
benzylpiperazine).............................................
(4) Cathinone.................................................. 1235
Some trade or other names: 2-amino-1-phenyl-1-propanone,
alpha-aminopropiophenone, 2-aminopropiophenone, and
norephedrone
(5) 4,4[min]-Dimethylaminorex (4,4[min]-DMAR; 4,5-dihydro-4- 1595
methyl-5-(4-methylphenyl)-2-oxazolamine; 4-methyl-5-(4-
methylphenyl)-4,5-dihydro-1,3-oxazol-2-amine).................
(6) Fenethylline............................................... 1503
(7) Mesocarb (N-phenyl-N [min]-(3-(1-phenylpropan-2-yl)-1,2,3- 1227
oxadiazol-3-ium-5-yl)carbamimidate)...........................
(8) 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.......................................................
(9) Methiopropamine (N-methyl-1-(thiophen-2-yl)propan-2-amine) 1478
(10) ()cis-4-methylaminorex (()cis-4,5-dihydro-4-methyl-5-phenyl-2-
oxazolamine)..................................................
(11) N-ethylamphetamine........................................ 1475
(12) 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:
[[Page 129]]
(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]- 7298
phenol (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)-(29) [Reserved]...........................................
(30) Fentanyl-related substances, their isomers, esters, 9850
ethers, salts and salts of isomers, esters and ethers........
(i) Fentanyl-related substance means any substance not otherwise
listed under another Administration Controlled Substance Code Number,
and for which no exemption or approval is in effect under section 505 of
the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355], that is
structurally related to fentanyl by one or more of the following
modifications:
(A) Replacement of the phenyl portion of the phenethyl group by any
monocycle, whether or not further substituted in or on the monocycle;
(B) Substitution in or on the phenethyl group with alkyl, alkenyl,
alkoxyl, hydroxyl, halo, haloalkyl, amino or nitro groups;
(C) Substitution in or on the piperidine ring with alkyl, alkenyl,
alkoxyl, ester, ether, hydroxyl, halo, haloalkyl, amino or nitro groups;
(D) Replacement of the aniline ring with any aromatic monocycle
whether or not further substituted in or on the aromatic monocycle; and/
or
(E) Replacement of the N-propionyl group by another acyl group.
(ii) This definition includes, but is not limited to, the following
substances: (A)-(B) [Reserved]
(31)-(49) [Reserved]...........................................
(50) 2-(2-(4-butoxybenzyl)-5-nitro-1H-benzimidazol-1-yl)-N,N- 9751
diethylethan-1-amine, its isomers, esters, ethers, salts, and
salts of isomers, esters and ethers (Other name: Butonitazene)
(51) 2-(2-(4-ethoxybenzyl)-1H-benzimidazol-1-yl)-N,N- 9765
diethylethan-1-amine, its isomers, esters, ethers, salts, and
salts of isomers, esters and ethers (Other names:
Etodesnitazene; etazene)......................................
(52) N,N-diethyl-2-(2-(4-fluorobenzyl)-5-nitro-1H-benzimidazol- 9756
1-yl)ethan-1-amine, its isomers, esters, ethers, salts, and
salts of isomers, esters and ethers (Other name: Flunitazene).
(53) N,N-diethyl-2-(2-(4-methoxybenzyl)-1H-benzimidazol-1- 9764
yl)ethan-1-amine, its isomers, esters, ethers, salts, and
salts of isomers, esters and ethers (Other name:
Metodesnitazene)..............................................
[[Page 130]]
(54) N,N-diethyl-2-(2-(4-methoxybenzyl)-5-nitro-1H-benzimidazol- 9757
1-yl)ethan-1-amine, its isomers, esters, ethers, salts, and
salts of isomers, esters and ethers (Other name: Metonitazene)
(55) 2-(4-ethoxybenzyl)-5-nitro-1-(2-(pyrrolidin-1-yl)ethyl)-1H- 9758
benzimidazole, its isomers, esters, ethers, salts, and salts
of isomers, esters and ethers (Other names: N-pyrrolidino
etonitazene; etonitazepyne)...................................
(56) N,N-diethyl-2-(5-nitro-2-(4-propoxybenzyl)-1H-benzimidazol- 9759
1-yl)ethan-1-amine, its isomers, esters, ethers, salts, and
salts of isomers, esters and ethers (Other name:
Protonitazene)................................................
[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.govinfo.gov.
Effective Date Notes:
1.At 83 FR 5191, Feb. 6, 2018, Sec. 1308.11 was amended by adding
paragraph (h)(30), effective Feb. 6, 2018, through Feb. 6, 2020.
Effective Feb. 6, 2020, Congress extended the effective period for
paragraph (h)(30) until May 6, 2021, by Public Law 116-114. Effective
May 4, 2021, Congress extended the effective period for paragraph
(h)(30) until October 22, 2021, by Public Law 117-12. Effective Sept.
30, 2021, Congress extended the effective period for paragraph (h)(30)
until Jan. 28, 2022, by Public Law 117-43. Effective Jan. 13, 2022,
Congress extended the effective period for paragraph (h)(30) until Feb.
18, 2022, by Public Law 117-70. Effective Feb. 18, 2022, Congress
extended the effective period for paragraph (h)(30) until Mar. 11, 2022,
by Public Law 117-86. Effective Mar. 11, 2022, Congress extended the
effective period for paragraph (h)(30) until Mar. 15, 2022 by Public Law
117-95. Effective Mar. 15, 2022, Congress extended the effective period
for paragraph (h)(30) until Dec. 31, 2022 by Public Law No. 117-103.
Effective Dec. 29, 2022, Congress extended the effective period for
paragraph (h)(30) until Dec. 31, 2024 by Public Law No. 117-328.
2. At 87 FR 21561, Apr. 12, 2022, Sec. 1308.11 was amended by
adding paragraphs (h)(50) through (h)(56), effective Apr. 12, 2022
through Apr. 12, 2024.
3. At 88 FR 13694, Mar. 6, 2023, Sec. 1308.11 was amended by
redesignating paragraphs (b)(22) through (93) as paragraphs (b)(23)
through (94), respectively and adding new paragraph (b)(22) and removing
and reserving paragraph (h)(49), effective Apr. 5, 2023. For the
convenience of the user, the added text is set forth as follows:
Sec. 1308.11 Schedule I.
* * * * *
(b) * * *
(22) brorphine (1-(1-(1-(4-bromophenyl)ethyl)piperidin-4-yl)- 9098
1,3-dihydro-2H-benzo[d]imidazol-2-one)........................
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, naldemedine, nalmefene, naloxegol,
naloxone, 6[beta]-naltrexol, naltrexone, and samidorphan, 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) Noroxymorphone.............................................. 9668
[[Page 131]]
(xi) Opium extracts............................................. 9610
(xii) Opium fluid............................................... 9620
(xiii) Oripavine................................................ 9330
(xiv) Oxycodone................................................. 9143
(xv) Oxymorphone................................................ 9652
(xvi) Powdered opium............................................ 9639
(xvii) Raw opium................................................ 9600
(xviii) Thebaine................................................ 9333
(xix) 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:
(i) Decocainized coca leaves or extraction of coca leaves, which
extractions do not contain cocaine or ecgonine;
(ii) [\123\I]ioflupane; or
(iii) [\18\F]FP-CIT.
(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
[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) Oliceridine (N-[(3-methoxythiophen-2-yl)methyl]({2-[(9R)-9- 9245
(pyridin-2-yl)-6-oxaspiro[4.5]decan-9-yl]ethyl{time} )amine)...
(19) Pethidine (meperidine)..................................... 9230
(20) Pethidine-Intermediate-A, 4-cyano-1-methyl-4- 9232
phenylpiperidine...............................................
(21) Pethidine-Intermediate-B, ethyl-4-phenylpiperidine-4- 9233
carboxylate....................................................
(22) Pethidine-Intermediate-C, 1-methyl-4-phenylpiperidine-4- 9234
carboxylic acid................................................
(23) Phenazocine................................................ 9715
(24) Piminodine................................................. 9730
(25) Racemethorphan............................................. 9732
(26) Racemorphan................................................ 9733
(27) Remifentanil............................................... 9739
(28) Sufentanil................................................. 9740
(29) Tapentadol................................................. 9780
(30) Thiafentanil............................................... 9729
(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........................................................
[[Page 132]]
(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]
(2) Dronabinol [(-)-delta-9-trans tetrahydrocannabinol] in an (7365)
oral solution in a drug product approved for marketing by the
U.S. Food and Drug Administration.............................
(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-phenethylpiperidine (ANPP)...................... 8333
(ii) N-phenyl-N-(piperidin-4-yl)propionamide (norfentanyl)...... 8366
[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.govinfo.gov.
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
[[Page 133]]
(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..................
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 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.............................
(iv) 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.............................
[[Page 134]]
(v) 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..............
(vi) 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]............................................. ......
(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.govinfo.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).....................................
(3) 2-[(dimethylamino)methyl]-1-(3-methoxyphenyl)cyclohexanol, 9752
its salts, optical and geometric isomers and salts of these
isomers (including tramadol)...................................
(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) Brexanolone................................................. 2400
(5) Bromazepam.................................................. 2748
(6) Camazepam................................................... 2749
(7) Carisoprodol................................................ 8192
(8) Chloral betaine............................................. 2460
(9) Chloral hydrate............................................. 2465
(10) Chlordiazepoxide........................................... 2744
(11) Clobazam................................................... 2751
(12) Clonazepam................................................. 2737
(13) Clorazepate................................................ 2768
(14) Clotiazepam................................................ 2752
(15) Cloxazolam................................................. 2753
(16) Daridorexant............................................... 2410
(17) Delorazepam................................................ 2754
(18) Diazepam................................................... 2765
(19) Dichloralphenazone......................................... 2467
(20) Estazolam.................................................. 2756
(21) Ethchlorvynol.............................................. 2540
[[Page 135]]
(22) Ethinamate................................................. 2545
(23) Ethyl loflazepate.......................................... 2758
(24) Fludiazepam................................................ 2759
(25) Flunitrazepam.............................................. 2763
(26) Flurazepam................................................. 2767
(27) Fospropofol................................................ 2138
(28) Halazepam.................................................. 2762
(29) Haloxazolam................................................ 2771
(30) Ketazolam.................................................. 2772
(31) Lemborexant................................................ 2245
(32) Loprazolam................................................. 2773
(33) Lorazepam.................................................. 2885
(34) Lormetazepam............................................... 2774
(35) Mebutamate................................................. 2800
(36) Medazepam.................................................. 2836
(37) Meprobamate................................................ 2820
(38) Methohexital............................................... 2264
(39) Methylphenobarbital (mephobarbital)........................ 2250
(40) Midazolam.................................................. 2884
(41) Nimetazepam................................................ 2837
(42) Nitrazepam................................................. 2834
(43) Nordiazepam................................................ 2838
(44) Oxazepam................................................... 2835
(45) Oxazolam................................................... 2839
(46) Paraldehyde................................................ 2585
(47) Petrichloral............................................... 2591
(48) Phenobarbital.............................................. 2285
(49) Pinazepam.................................................. 2883
(50) Prazepam................................................... 2764
(51) Quazepam................................................... 2881
(52) Remimazolam................................................ 2846
(53) Suvorexant................................................. 2223
(54) Temazepam.................................................. 2925
(55) Tetrazepam................................................. 2886
(56) Triazolam.................................................. 2887
(57) Zaleplon................................................... 2781
(58) Zolpidem................................................... 2783
(59) Zopiclone.................................................. 2784
(d) [Reserved]
(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) Serdexmethylphenidate...................................... 1729
(12) Sibutramine................................................ 1675
(13) Solriamfetol (2-amino-3-phenylpropyl carbamate; 1650
benzenepropanol, beta-amino-, carbamate (ester))...............
(14) 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
(3) Eluxadoline (5-[[[(2S)-2-amino-3-[4-aminocarbonyl)-2,6-
dimethylphenyl]-1-oxopropyl][(1S)-1-(4-phenyl-1H-imidazol-2-
yl)ethyl]amino]methyl]-2-methoxybenzoic acid) (including its
optical isomers) and its salts, isomers, and salts of isomers
(9725).........................................................
[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.govinfo.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]
[[Page 136]]
(2) [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 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) Brivaracetam ((2S)-2-[(4R)-2-oxo-4-propylpyrrolidin-1-yl] 2710
butanamide) (also referred to as BRV; UCB-34714; Briviact)
(including its salts)..........................................
(2) Cenobamate ([(1R)-1-(2-chlorophenyl)-2-(tetrazol-2-yl)ethyl] 2720
carbamate; 2H-tetrazole-2-ethanol, alpha-(2-chlorophenyl)-,
carbamate (ester), (alphaR)-; carbamic acid (R)-(+)-1-(2-
chlorophenyl)-2-(2H-tetrazol-2-yl)ethyl ester).................
(3) Ezogabine [N-[2-amino-4-(4-fluorobenzylamino)-phenyl]- 2779
carbamic acid ethyl ester].....................................
(4) Ganaxolone (3[alpha]-hydroxy-3[beta]-methyl-5[alpha]-pregnan- 2401
20-one)........................................................
(5) Lacosamide [(R)-2-acetoamido-N-benzyl-3-methoxy- 2746
propionamide]..................................................
(6) Lasmiditan [2,4,6-trifluoro-N-(6-(1-methylpiperidine-4- 2790
carbonyl)pyridine-2-yl-benzamide]..............................
(7) 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; 81 FR
29491, May 12, 2016; 83 FR 48953, Sept 28, 2018; 85 FR 5562, Jan. 31,
2020; 85 FR 13746, Mar. 10, 2020; 85 FR 51645, Aug. 21, 2020; 87 FR
32996, June 1, 2022]
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 Drug and Chemical Evaluation Section,
Diversion Control Division, Drug Enforcement Administration. See the
Table of DEA Mailing Addresses in Sec. 1321.01 of this chapter for the
current mailing address.
[[Page 137]]
(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; 81 FR 97021, Dec. 30, 2016]
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)
----------------------------------------------------------------------------------------------------------------
Aphena Pharma Solutions--New Nasal Decongestant .............. IN Levmetamfetamine 50.00
York, LLC. Inhaler/Vapor (l-
Inhaler. Desoxyephedrine).
Bioline Laboratories........... Theophed.......... 00719-1945 TB Phenobarbital..... 8.00
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
Procter & Gamble Co., The...... Vicks VapoInhaler. 37000-686-01 IN Levmetamfetamine 50.00
(l-
Desoxyephedrine).
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
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; 80 FR 65634, 65637, Oct. 27, 2015; 81 FR 6453,
Feb. 8, 2016]
[[Page 138]]
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 Drug and Chemical
Evaluation Section, Diversion Control Division, 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;
(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,
[[Page 139]]
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; 81 FR 97021, Dec. 30, 2016]
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 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
[[Page 140]]
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 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.govinfo.gov.
[[Page 141]]
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 Drug and Chemical Evaluation
Section, Diversion Control Division, 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 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; 81
FR 97021, Dec. 30, 2016]
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
[[Page 142]]
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 Drug and Chemical Evaluation Section, Diversion Control
Division, 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 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
[[Page 143]]
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; 81 FR 97021, Dec. 30, 2016]
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 any part of the Act, pursuant to
paragraph (a) of this section, may apply to the Drug and Chemical
Evaluation Section, Diversion Control Division, 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.
[[Page 144]]
(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; 81 FR 97021, Dec. 30, 2016]
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 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.
[[Page 145]]
(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 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
[[Page 146]]
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 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.
[[Page 147]]
(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 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
[[Page 148]]
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 Temporary scheduling.
(a) 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 Drug
Enforcement Administration may place a substance into Schedule I on a
temporary basis, if it 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 calendar days
from:
(1) The date of publication by the Administration of a notice in the
Federal Register of its intention to issue such order and the grounds
upon which such order is to be issued; and
(2) The date the Administration has transmitted notification to the
Secretary of Health and Human Services of the Administration's intention
to issue such order.
(b) An order issued under this section will 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 two years 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
Administration may extend the temporary scheduling for up to one year.
[81 FR 97021, Dec. 30, 2016]
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.
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; default.
1309.54 Burden of proof.
1309.55 Time and place of hearing.
[[Page 149]]
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 for distribution the applicant shall pay an annual fee of
$3,699.
(b) For each application for registration or reregistration to
distribute (either retail distribution or non-retail distribution),
import, or export a list I chemical, the applicant shall pay an annual
fee of $1,850.
[85 FR 44734, July 24, 2020]
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 online using the secure application portal at
www.DEAdiversion.usdoj.gov.
(b) Payment shall be made online by Automated Clearing House funds
transfer, by credit card, or by any other means made available at the
time of submission using the secure application portal at
www.DEAdiversion.usdoj.gov.
[87 FR 21022, Apr. 11, 2022]
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:
[[Page 150]]
Summary of Registration Requirements and Limitations
----------------------------------------------------------------------------------------------------------------
Registration Coincident
Business activity Chemicals DEA forms Application period activities
fee (years) allowed
----------------------------------------------------------------------------------------------------------------
(1) Manufacturing............. List I,.......... New-510......... 3,699 1 May distribute
Drug products Renewal-510a.... that chemical
containing for which
ephedrine, registration
pseudoephedrine, was issued; may
phenylpropanolam not distribute
ine. any chemical
for which not
registered.
(2) Distributing.............. List I,.......... New-510......... 1,850 1
Scheduled listed Renewal-510a....
chemical
products.
(3) Importing................. List I,.......... New-510......... 1,850 1 May distribute
Drug Products Renewal-510a.... that chemical
containing for which
ephedrine, registration
pseudoephedrine, was issued; may
phenylpropanolam not distribute
ine. any chemical
for which not
registered.
(4) Exporting................. List I,.......... New-510......... 1,850 1 ................
Scheduled listed Renewal-510a....
chemical
products.
----------------------------------------------------------------------------------------------------------------
[75 FR 4980, Feb. 1, 2010, as amended at 77 FR 4236, Jan. 27, 2012; 77
FR 15250, Mar. 15, 2012; 85 FR 44734, July 24, 2020]
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 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
[[Page 151]]
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 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
[[Page 152]]
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 customs
officer, any officer or employee of the U.S. Food and Drug
Administration, and any Federal or Insular officer who is lawfully
engaged in the enforcement of any federal law relating to listed
chemicals, controlled substances, drugs, or customs, and is duly
authorized to possess and distribute List I chemicals 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 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.
[60 FR 32454, June 22, 1995, as amended at 81 FR 97021, Dec. 30, 2016]
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
[[Page 153]]
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 using the
secure application portal at www.DEAdiversion.usdoj.gov.
(b) Any person who is registered pursuant to Sec. 1309.21, shall
apply for reregistration on DEA Form 510a using the secure application
portal at www.DEAdiversion.usdoj.gov.
(c) DEA Forms 510 and 510a may be obtained online at
www.DEAdiversion.usdoj.gov. DEA will send renewal notifications via
email to registrants approximately calendar 60 days prior to their
registration expiration date. Registrants are responsible for keeping
their email address current in the secure application portal on DEA's
website throughout the duration of their registration. Only applications
submitted online through the secure application portal on DEA's website
will be accepted for processing.
(d) Each application for registration must include the
Administration Chemical Code Number, as set forth in Sec. 1310.02 of
this chapter, for each List I chemical to be manufactured, 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 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; 81
FR 97021, Dec. 30, 2016; 87 FR 21023, Apr. 11, 2022]
Sec. 1309.33 Filing of application; joint filings.
All applications for registration shall be submitted online at
www.DEAdiversion.usdoj.gov for filing. The appropriate registration fee
and any required attachments must accompany the application.
[87 FR 21023, Apr. 11, 2022]
Sec. 1309.34 Acceptance for filing; defective applications.
(a) Applications submitted for filing are dated upon receipt. If the
application is found to be complete, the application will be accepted
for filing. Applications failing to comply with the requirements of this
part will not be accepted for filing.
(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.
[60 FR 32454, June 22, 1995, as amended at 87 FR 21023, Apr. 11, 2022]
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
[[Page 154]]
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.
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
[[Page 155]]
(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 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
[[Page 156]]
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)(1) When to File: Hearing Request. A party that wishes to request
a hearing in response to an order to show cause must file with the
Office of the Administrative Law Judges and serve on DEA such request no
later than 30 days following the date of receipt of the order to show
cause. Service of the request on DEA shall be accomplished by sending it
to the address, or email address, provided in the order to show cause.
(2) When to File: Answer. A party requesting a hearing shall also
file with the Office of the Administrative Law Judges and serve on DEA
an answer to the order to show cause no later than 30 days following the
date of receipt of the order to show cause. A party shall also serve its
answer on DEA at the address, or email address, provided in the order to
show cause. The presiding officer may, upon a showing of good cause by
the party, consider an answer that has been filed out of time.
(3) Contents of Answer; Effect of Failure to Deny. For each factual
allegation in the order to show cause, the answer shall specifically
admit, deny, or state that the party does not have, and is unable to
obtain, sufficient information to admit or deny the allegation. When a
party intends in good faith to deny only a part of an allegation, the
party shall specify so much of it as is true and shall deny only the
remainder. A statement of a lack of information shall have the effect of
a denial. Any factual allegation not denied shall be deemed admitted.
(4) Amendments. Prior to the issuance of the prehearing ruling, a
party may as a matter of right amend its answer one time. Subsequent to
the issuance of the prehearing ruling, a party may amend its answer only
with leave of the presiding officer. Leave shall be freely granted when
justice so requires.
(e) When authorized by the Administrator, any agent of the
Administration may serve the order to show cause.
[60 FR 32454, June 22, 1995, as amended at 81 FR 97021, Dec. 30, 2016;
87 FR 68044, Nov. 14, 2022]
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 1309.55, 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.
[60 FR 32454, June 22, 1995, as amended at 81 FR 97021, Dec. 30, 2016]
[[Page 157]]
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; default.
(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)(1) Any person entitled to a hearing pursuant to Sec. 1309.42 or
1309.43 who fails to file a timely request for a hearing, shall be
deemed to have waived their right to a hearing and to be in default,
unless the registrant/applicant establishes good cause for failing to
file a timely hearing request. Any person who has failed to timely
request a hearing under paragraph (a) may seek to be excused from the
default by filing a motion with the Office of Administrative Law Judges
establishing good cause to excuse the default no later than 45 days
after the date of receipt of the order to show cause. Thereafter, any
person who has failed to timely request a hearing under paragraph (a)
and seeks to be excused from the default, shall file such motion with
the Office of the Administrator, which shall have exclusive authority to
rule on the motion.
(2) Any person who has requested a hearing pursuant to this section
but who fails to timely file an answer and who fails to demonstrate good
cause for failing to timely file an answer, shall be deemed to have
waived their right to a hearing and to be in default. Upon motion of
DEA, the presiding officer shall then enter an order terminating the
proceeding.
(3) In the event DEA fails to prosecute or a person who has
requested a hearing fails to plead (including by failing to file an
answer) or otherwise defend, said party shall be deemed to be in default
and the opposing party may move to terminate the proceeding. Upon such
motion, the presiding officer shall then enter an order terminating the
proceeding, absent a showing of good cause by the party deemed to be in
default. Upon termination of the proceeding by the presiding officer, a
party may seek relief only by filing a motion establishing good cause to
excuse its default with the Office of the Administrator.
(c) If any person entitled to participate in a hearing pursuant to
this section fails to file a notice of appearance either as part of a
hearing request or separately, or if such person so files and fails to
appear at the hearing, such person shall be deemed to have waived their
opportunity to participate in the hearing, unless such person shows good
cause for such failure.
(d) A default, unless excused, shall be deemed to constitute a
waiver of the applicant's/registrant's right to a hearing and an
admission of the factual allegations of the order to show cause.
(e)(1) In the event that a registrant/applicant is deemed to be in
default pursuant to paragraph (b)(1) of this section and has not
established good cause to be excused from the default, or the presiding
officer has issued an order termination the proceeding pursuant to
paragraphs (b)(2) or (b)(3) of this section, DEA may then file a request
for final agency action with the Administrator, along with a record to
support its request. In such circumstances, the Administrator may enter
a default final order pursuant to Sec. 1316.67 of this chapter.
(2) In the event that DEA is deemed to be in default and the
presiding officer has issued an order terminating the proceeding
pursuant to paragraph (b)(3) of this section, the presiding officer
shall transmit the record to the Administrator for his consideration no
later than five business days after the date of issuance of the order.
Upon termination of the proceeding by the presiding officer, DEA may
seek relief only by filing a motion with the Office of the Administrator
establishing good cause to excuse its default.
[[Page 158]]
(3) A party held to be in default may move to set aside a default
final order issued by the Administrator by filing a motion no later than
30 days from the date of issuance by the Administrator of a default
final order. Any such motion shall be granted only upon a showing of
good cause to excuse the default.
[60 FR 32454, June 22, 1995. Redesignated at 62 FR 13968, Mar. 24, 1997.
87 FR 68045, Nov. 14, 2022]
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]
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
[[Page 159]]
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;
(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; and
(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; 81 FR 97021, Dec. 30, 2016]
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
[[Page 160]]
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;
IMPORTATION AND EXPORTATION OF CERTAIN MACHINES--Table of Contents
Sec.
1310.01 Definitions.
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) Alpha-phenylacetoacetonitrile and its salts, optical 8512
isomers, and salts of optical isomers (APAAN)..................
(2) Anthranilic acid, its esters, and its salts................. 8530
(3) Benzyl cyanide.............................................. 8735
(4) Ephedrine, its salts, optical isomers, and salts of optical 8113
isomers........................................................
(5) Ergonovine and its salts.................................... 8675
(6) Ergotamine and its salts.................................... 8676
(7) N-Acetylanthranilic acid, its esters, and its salts......... 8522
(8) Norpseudoephedrine, its salts, optical isomers, and salts of 8317
optical isomers................................................
(9) Phenylacetic acid, its esters, and its salts................ 8791
[[Page 161]]
(10) Phenylpropanolamine, its salts, optical isomers, and salts 1225
of optical isomers.............................................
(11) Piperidine and its salts................................... 2704
(12) Pseudoephedrine, its salts, optical isomers, and salts of 8112
optical isomers................................................
(13) 3,4-Methylenedioxyphenyl-2-propanone....................... 8502
(14) Methylamine and its salts.................................. 8520
(15) Ethylamine and its salts................................... 8678
(16) Propionic anhydride........................................ 8328
(17) Isosafrole................................................. 8704
(18) Safrole.................................................... 8323
(19) Piperonal.................................................. 8750
(20) N-Methylephedrine, its salts, optical isomers, and salts of 8115
optical isomers (N-Methylephedrine)............................
(21) N-Methylpseudoephedrine, its salts, optical isomers, and 8119
salts of optical isomers.......................................
(22) Hydriodic Acid............................................. 6695
(23) Benzaldehyde............................................... 8256
(24) Nitroethane................................................ 6724
(25) 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).......................................................
(26) Red phosphorus............................................. 6795
(27) White phosphorus (Other names: Yellow Phosphorus).......... 6796
(28) Hypophosphorous acid and its salts (Including ammonium 6797
hypophosphite, calcium hypophosphite, iron hypophosphite,
potassium hypophosphite, manganese hypophosphite, magnesium
hypophosphite and sodium hypophosphite)........................
(29) N-phenethyl-4-piperidone (NPP)............................. 8332
(30) Iodine..................................................... 6699
(31) Ergocristine and its salts................................. 8612
(32)N-(1-benzylpiperidin-4-yl)-N-phenylpropionamide 8334
(benzylfentanyl) and its salts.................................
(33)N-phenylpiperidin-4-amine(4-anilinopiperidine; N-phenyl-4- 8335
piperidinamine; 4-AP), its amides, its carbamates, and its
salts..........................................................
(34) 3,4-MDP-2-P methyl glycidate (PMK glycidate) and its 8535
optical and geometric isomers..................................
(35) 3,4-MDP-2-P methyl glycidic acid (PMK glycidic acid) and 8525
its salts, optical and geometric isomers, and salts of isomers.
(36) Alpha-phenylacetoacetamide (APAA) and its optical isomers. 8515
(37) methyl alpha-phenylacetoacetate (MAPA; methyl 3-oxo-2- 8795
phenylbutanoate) and its optical isomers.......................
(38) [Reserved].................................................
(39) 1-boc-4-AP (tert-butyl 4-(phenylamino)piperidine-1- 8336
carboxylate) and its salts.....................................
(b) List II chemicals:
(1) Acetic anhydride............................................ 8519
(2) Acetone..................................................... 6532
(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
[[Page 162]]
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; 82 FR 32460, July 14,
2017; 85 FR 20828, Apr. 15, 2020; 86 FR 24707, May 10, 2021; 86 FR
64366, Nov. 18, 2021; 87 FR 67552, Nov. 9, 2022]
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
Sec. 1310.05.
(c)(1) Each regulated person who engages in a transaction with a
nonregulated person which:
(i) Involves ephedrine, pseudoephedrine, phenylpropanolamine, or
gamma hydroxybutyric acid (including drug products containing these
chemicals or controlled substance); and
(ii) Uses or attempts to use the U.S. Postal Service or any private
or commercial carrier must, on a monthly basis, report to the
Administration each such transaction conducted during the previous month
as specified in Sec. Sec. 1310.05(e) and 1310.06(k) on DEA Form 453
through the DEA Diversion Control Division secure network application.
(2) Each regulated person who engages in an export transaction
which:
(i) Involves ephedrine, pseudoephedrine, phenylpropanolamine, or
gamma hydroxybutyric acid (including drug products containing these
chemicals or controlled substance); and
(ii) Uses or attempts to use the U.S. Postal Service or any private
or commercial carrier must, on a monthly basis, report each such
transaction conducted during the previous month as specified in
Sec. Sec. 1310.05(e) and 1310.06(k) on DEA Form 453 through the DEA
Diversion Control Division secure network application.
[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; 81 FR 97022, Dec. 30, 2016]
[[Page 163]]
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 are subject to the requirements of part 1314 of this chapter.
(2) List II Chemicals:
(i) Imports and Exports
[[Page 164]]
----------------------------------------------------------------------------------------------------------------
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) Alpha-phenylacetoacetamide (APAA) and its optical isomers
(ii) Alpha-phenylacetoacetonitrile and its salts, optical isomers,
and salts of optical isomers (APAAN)
(iii) Ephedrine, its salts, optical isomers, and salts of optical
isomers;
(iv) Ergocristine and its salts
(v) Gamma-Butyrolactone (Other names include: GBL; Dihydro-2(3H)-
furanone; 1,2-Butanolide; 1,4-Butanolide; 4-Hydroxybutanoic acid
lactone; gamma-hydroxybutyric acid lactone)
(vi) Hypophosphorous acid and its salts (including ammonium
hypophosphite, calcium hypophosphite, iron hypophosphite, potassium
hypophosphite, manganese hypophosphite, magnesium hypophosphite, and
sodium hypophosphite)
(vii) Iodine
(viii) 3,4-MDP-2-P methyl glycidate (PMK glycidate) and its optical
and geometric isomers
(ix) 3,4-MDP-2-P methyl glycidic acid (PMK glycidic acid) and its
salts, optical and geometric isomers, and salts of isomers
(x) methyl alpha-phenylacetoacetate (MAPA; methyl 3-oxo-2-
[[Page 165]]
phenylbutanoate) and its optical isomers
(xi) N-(1-benzylpiperidin-4-yl)-N-phenylpropionamide
(benzylfentanyl) and its salts
(xii) N-phenethyl-4-piperidone (NPP)
(xiii) N-phenylpiperidin-4-amine (4-anilinopiperidine; N-phenyl-4-
piperidinamine; 4-AP), its amides, its carbamates, and its salts
(xiv) Pseudoephedrine, its salts, optical isomers, and salts of
optical isomers
(xv) Phenylpropanolamine, its salts, optical isomers, and salts of
optical isomers
(xvi) Red phosphorus
(xvii) 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.govinfo.gov.
Editorial Note: At 87 FR 67552, Nov. 9, 2022, Sec. 1310.4 was
amended, however, the amendment could not be incorporated due to
inaccurate amendatory instruction.
Sec. 1310.05 Reports.
(a)(1) 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 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. The regulated person will orally report to the Special
Agent in Charge of the DEA Divisional Office 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. The regulated person must file a written report
of the transaction(s) with the Special Agent in Charge of the DEA
Divisional Office as set forth in Sec. 1310.06 within 15 calendar days
after the regulated person becomes aware of the circumstances of the
event.
(2) 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 proposed regulated transaction with a
person whose description or other identifying characteristic the
Administration has previously furnished to the regulated person. The
regulated person will orally report to the Special Agent in Charge of
the DEA Divisional Office at the earliest practicable opportunity after
the regulated person becomes aware of the circumstances involved. 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.
(b)(1) 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 listed chemical under the control of the regulated
person. The regulated person will orally report to the Special Agent in
Charge of the DEA Divisional Office at
[[Page 166]]
the earliest practicable opportunity after the regulated person becomes
aware of the circumstances involved. Unless the loss or disappearance
occurs during an import or export transaction, the supplier is
responsible for reporting all in-transit losses of any listed chemical
by their agent or the common or contract carrier. In an import
transaction, once a shipment has been released by the customs officer at
the port of entry, the importer is responsible for reporting all in-
transit losses of any listed chemical by their agent or the common or
contract carrier. In an export transaction, the exporter is responsible
for reporting all in-transit losses of any listed chemical by their
agent or the common or contract carrier until the shipment has been
released by the customs officer at the port of export. The regulated
person must also file a complete and accurate DEA Form 107, in
accordance with Sec. 1310.06(d), with the Administration through the
DEA Diversion Control Division secure network application within 15
calendar days after becoming aware of the circumstances requiring the
report. Unusual or excessive losses or disappearances must be reported
whether or not the listed chemical is subsequently recovered or the
responsible parties are identified and action taken against them. When
determining whether a loss or disappearance of a listed chemical was
unusual or excessive, the regulated persons should consider, among
others, the following factors:
(i) The actual quantity of a listed chemical;
(ii) The specific listed chemical involved;
(iii) Whether the loss or disappearance of the listed chemical can
be associated with access to those listed chemicals by specific
individuals, or whether the loss or disappearance can be attributed to
unique activities that may take place involving the listed chemical; and
(iv) A pattern of losses or disappearances over a specific time
period, whether the losses or disappearances appear to be random, and
the result of efforts taken to resolve the losses.
(v) If known, the regulated person should also consider whether the
specific listed chemical was a likely candidate for diversion as well as
local trends and other indicators of the diversion potential of the
listed chemical.
(2) Each regulated person must orally report any domestic regulated
transaction in a tableting machine or an encapsulating machine to the
Special Agent in Charge of the DEA Divisional Office for the area in
which the regulated person making the report is located when the order
is placed with the seller. The regulated person also must file a report
of the transaction (on DEA Form 452) with the Administration through the
DEA Diversion Control Division secure network application within 15
calendar days after the order has been shipped by the seller. A report
(DEA Form 452) may list more than one machine for a single transaction.
Upon receipt and review, the Administration will assign a completed
report a transaction identification number. The report will not be
deemed filed until a transaction identification number has been issued
by the Administration.
(c) Imports and exports of tableting machines and encapsulating
machines. (1) Each regulated person who imports or exports a tableting
machine, or encapsulating machine, must file a report of such
importation or exportation on DEA Form 452 with the Administration
through the DEA Diversion Control Division secure network application,
at least 15 calendar days before the anticipated arrival at the port of
entry or port of export. 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 report to the
Administration as far in advance as possible. A separate report (DEA
Form 452) must be filed for each shipment, in accordance with Sec.
1310.06(e). Upon receipt and review, the Administration will assign a
completed report a transaction identification number. The report will
not be deemed filed until a transaction identification number has been
issued by the Administration. The importer or exporter may only proceed
with the transaction once the transaction identification number has been
issued. Any tableting machine
[[Page 167]]
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 previously been furnished
to the regulated person by the Administration unless the transaction is
approved by the Administration.
(2) Denied release at the port of entry. In the event that a
shipment of tableting or encapsulating machine(s) has been denied
release by a customs officer at the port of entry for any reason, the
importer who attempted to import the shipment must, within 5 business
days of the denial, report to the Administration that the shipment was
denied, the basis for denial, and such other information as is required
by Sec. 1310.06(g). Such report must be transmitted to the
Administration through the DEA Diversion Control Division secure network
application. Upon the importer's report of a denied entry, DEA will
assign the report a transaction identification number and the original
import notification will be void and of no effect. No shipment of
tableting machines or encapsulating machines denied entry for any reason
will be allowed entry without a subsequent refiling of an amended DEA
Form 452 by the regulated person. In such circumstances, the regulated
person may proceed with the release of the tableting machines or
encapsulating machines upon receipt of a transaction identification
number for the refiled and amended DEA Form 452 without regard to the
15-day advance filing requirement in paragraph (c)(1) of this section,
so long as the article is otherwise cleared for entry under U.S. customs
laws.
(d) Each regulated bulk manufacturer of a listed chemical must
submit manufacturing, inventory and use data on an annual basis as set
forth in Sec. 1310.06(j). This data must be submitted annually to the
Drug and Chemical Evaluation Section, Diversion Control Division, 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 drugs or other products that are exempted
under paragraph (1)(iv) or (v) of the definition of regulated
transaction in Sec. 1300.02 of this chapter except as set forth in
Sec. 1310.06(i)(5). Bulk manufacturers that produce a listed chemical
solely for internal consumption are not required to report for that
listed chemical. For purposes of these reporting requirements, internal
consumption consists of any quantity of a listed chemical otherwise not
available for further resale or distribution. Internal consumption
includes (but is not 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(j)
and such information is separate or readily retrievable from the report,
that report may be submitted in satisfaction of this requirement. Each
report must be submitted to the DEA under company letterhead and signed
by an appropriate, responsible official. For purposes of this paragraph
(d) 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 forms of products which contain a listed
chemical.
(e) Each regulated person required to report pursuant to Sec.
1310.03(c) must file a report containing the transaction identification
number for each such transaction (if the regulated person is
[[Page 168]]
required to obtain a transaction identification number under part 1313of
this chapter) and information set forth in Sec. 1310.06(k), on or
before the 15th day of each month following the month in which the
distributions took place.
(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
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; 81 FR 97022, Dec. 30, 2016]
Sec. 1310.06 Content of records and reports.
(a) Each record required by Sec. 1310.03(a) must include the
following:
(1) The name/business name, address/business address, and contact
information (e.g., telephone number(s), email address (es), etc.), and,
if required, DEA registration number of each party to the regulated
transaction.
(2) The date of the regulated transaction.
(3) The quantity, chemical name, and, if applicable, National Drug
Code (NDC) number. If NDC number is not applicable, the form of
packaging of the listed chemical or a description of the tableting
machine or encapsulating machine (including make, model, serial number,
if any, and whether the machine is manual or electric).
(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 will 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 will 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 U.S. Food and Drug
Administration regulations relating to the distribution of prescription
drugs, as set forth in 21 CFR part 205, will be considered adequate for
satisfying the requirements of paragraph (a) of this section with
respect to distributions.
[[Page 169]]
(c)(1) Each report required by Sec. 1310.05(a) must include the
information as specified by paragraph (a) of this section, the basis for
making the report, and, where obtainable, the registration number of the
other party, if such party is registered. A report of an uncommon method
of payment or delivery submitted in accordance with Sec. 1310.05(a)(1)
must also include a reason why the method of payment or delivery was
uncommon.
(2) A suggested format for the reports in Sec. 1310.05(a)(1) is
provided below:
Shipping Address (if different than purchaser Address):
Street__________________________________________________________________
City____________________________________________________________________
State___________________________________________________________________
Zip_____________________________________________________________________
Date of Shipment________________________________________________________
Description of Listed Chemical:
Chemical Name___________________________________________________________
Quantity________________________________________________________________
National Drug Code (NDC) Number(s), or Form(s) of Packaging_____________
Other:
The basis (i.e., reason) for making the report:_________________________
Any additional pertinent information:___________________________________
(d) Each report of an unusual or excessive loss or disappearance of
a listed chemical required by Sec. 1310.05(b)(1) (on DEA Form 107),
must include the following information:
(1) The name/business name, address/business address, and contact
information (e.g., telephone number(s), email address (es), etc.), and,
if applicable, DEA registration number of each party to the regulated
transaction.
(2) The date (or estimated date) on which unusual or excessive loss
or disappearance occurred, and the actual date on which the unusual or
excessive loss or disappearance was discovered by the regulated person.
(3) The quantity, chemical name, and National Drug Code (NDC)
number, if applicable or if not the form of packaging of the listed
chemical.
(4) The type of business conducted by the regulated person, (e.g.,
grocery store, pharmacy/drug store, discount department store, warehouse
club or superstore, convenience store, specialty food store, gas
station, mobile retail vendor, mail-order, etc.) if the regulated person
is not a DEA registrant.
(e)(1) Each report of an importation of a tableting machine or an
encapsulating machine required by Sec. 1310.05(c)(1) (on DEA Form 452)
must include the following information:
(i) The name/business name, address/business address, and contact
information (e.g., telephone number(s), email address(es), etc.) of the
regulated person; the name/business name, address/business address, and
contact information (e.g., telephone number(s), email address(es), etc.)
of the import broker or forwarding agent, if any;
(ii) A description of each machine (including make, model, serial
number, if any, and whether the machine is manual or electric) and the
number of machines being received;
(iii) The anticipated date of arrival at the port of entry, and the
anticipated port of entry;
(iv) The name/business name, address/business address, and contact
information (e.g., telephone number(s), email address(es), etc.) of the
consignor in the foreign country of exportation;
(v) The intended medical, commercial, scientific, or other
legitimate use of the machine; and
(vi) Any proposed changes in identifying information of the imported
machines (e.g., name, brand, serial number, if any, etc.) that will take
place after importation.
(2) Each report of an exportation of a tableting machine or an
encapsulating machine required by Sec. 1310.05(c)(1) (on DEA Form 452)
must include the following information:
(i) The name/business name, address/business address, and contact
information (e.g., telephone number(s), email address(es), etc.) of the
regulated person; the name/business name, address/business address, and
contact information (e.g., telephone number(s), email address(es), etc.)
of the export broker (if applicable);
(ii) A description of each machine (including make, model, serial
number, if any, and whether the machine is manual or electric) and the
number of machines being received;
(iii) The anticipated date of arrival at the port of export, the
foreign port and country of entry; and
[[Page 170]]
(iv) The name/business name, address/business address, and contact
information (e.g., telephone number(s), email address(es), etc.) of the
consignee in the country where the shipment is destined; the name(s)/
business name(s) and address(es)/business address(es), and contact
information (e.g., telephone number(s), email address(es), etc.) of the
intermediate consignee(s) (if any).
(f) Each report of a domestic regulated transaction in a tableting
machine or encapsulating machine required by Sec. 1310.05(b)(2) (on DEA
Form 452) must include the following information:
(1) The name/business name, address/business address, and contact
information (e.g., telephone number(s), email address(es), etc.) of the
regulated person; the name/business name, address/business address, and
contact information (e.g., telephone number(s), email address(es), etc.)
of the purchaser;
(2) A description of each machine (including make, model, serial
number, if any, and whether the machine is manual or electric) and the
number of machines being received; and
(3) Any changes made by the regulated person in identifying
information of the machines (e.g., name, brand, serial number, etc.).
(g) Each report of a denied release by a customs officer at the port
of entry of a tableting machine or an encapsulating machine required by
Sec. 1310.05(c)(2) must include the following information: the quantity
of machines denied release; a concise description of the machines denied
release; the date on which release was denied; the port where the denial
of release was issued from; and the basis for the denial.
(h) Return information. (1) Within 30 calendar days after actual
receipt of a tableting or encapsulating machine, or within 10 calendar
days after receipt of a written request by the Administration to the
importer, whichever is sooner, the importer must file a report with the
Administration (on DEA Form 452) specifying the particulars of the
transaction utilizing the DEA Diversion Control Division secure network
application. This report must include the following information: The
date on which a customs officer at the port of entry released the
machine(s); the date on which the machine(s) arrived at the final
destination; the port of entry where the machine(s) were actually
released by a customs officer; the actual quantity of machines released
by a customs officer; the actual quantity of machines that arrived at
the final destination; a description of each tableting or encapsulating
machine imported (including make, model, and serial number, if any); any
changes in identifying information of the imported machines (e.g., name,
brand, serial number, if any, etc.) that will take place after
importation; and any other information as the Administration may from
time to time specify. Upon receipt and review, the Administration will
assign a transaction identification number to a completed report. The
report will not be deemed filed until the Administration has issued a
transaction identification number. A single return declaration may
include the particulars of both the importation and distribution. For
DEA reporting purposes, import responsibilities are concluded upon the
receipt of the machines by the importer. Once machines are received by
the importer, domestic transaction reporting requirements commence.
Distributions of tableting and encapsulating machines from the importer
to their customers must be reported as domestic regulated transactions
in accordance with Sec. 1310.05(b)(2).
(2) Within 30 calendar days after the tableting or encapsulating
machine is released by a customs officer at the port of export, or
within 10 calendar days after receipt of a written request by the
Administration to the exporter, whichever is sooner, the exporter must
file a report with the Administration (on DEA Form 452) through the DEA
Diversion Control Division secure network application specifying the
particulars of the transaction. This report must include the following
information: The date on which the machine(s) was (were) released by a
customs officer at the port of export; the actual quantity of machines
released; a description of each tableting or encapsulating machine
released (including make, model, serial number, if any,
[[Page 171]]
and whether the machine is manual or electric); and any other
information as the Administration may from time to time specify.
(i) 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 filed
with the Administration through the DEA Diversion Control Division
secure network application, following the return at the earliest
practicable opportunity after the regulated person becomes aware of the
circumstances involved. 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.
(j) Each annual report required by Sec. 1310.05(d) must provide the
following information for each listed chemical manufactured:
(1) The name/business name, address/business address, and contact
information (e.g., telephone number(s), email address(es), etc.) and
chemical registration number (if any) of the manufacturer.
(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 paragraph (1)(iv)
or (v) 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.
(k) Each monthly report required by Sec. Sec. 1310.03(c) and
1310.05(e) (on DEA Form 453) must provide the following information for
each transaction:
(1) Supplier name/business name, address/business address, and
contact information (e.g., telephone number(s), email address(es), etc.)
and registration number.
(2) Purchaser's name/business name, address/business address, and
contact information (e.g., telephone number(s), email address(es),
etc.).
(3) Name/business name, address/business address shipped to (if
different from purchaser's name/address).
(4) Chemical name, National Drug Code (NDC) number, if applicable,
and total amount shipped.
(5) Date of shipment.
(6) Product name (if drug product).
(7) Dosage form (if drug product) (e.g., pill, tablet, liquid).
(8) Dosage strength (if drug product) (e.g., 30mg, 60mg, per dose
etc.).
(9) Number of dosage units (if drug product) (e.g., 100 doses per
package).
(10) Package type (if drug product) (e.g., bottle, blister pack,
etc.).
(11) Number of packages (if drug product) (e.g., 10 bottles).
(12) Lot number (if drug product).
(l) Information provided in reports required by Sec. 1310.05(e)
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.
[81 FR 97023, Dec. 30, 2016]
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
[[Page 172]]
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 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
[[Page 173]]
(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 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
[[Page 174]]
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 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
[[Page 175]]
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 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
[[Page 176]]
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
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.
(n)(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 alpha-phenylacetoacetonitrile
(APAAN) and
[[Page 177]]
its salts, optical isomers, and salts of optical isomers, including
regulated chemical mixtures pursuant to Sec. 1310.12, is temporarily
exempted from the registration requirement, provided that the DEA
receives a properly completed application for registration or
application for exemption for a chemical mixture containing alpha-
phenylacetoacetonitrile (APAAN) and its salts, optical isomers, and
salts of optical isomers, pursuant to Sec. 1310.13 on or before August
14, 2017. 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 alpha-phenylacetoacetonitrile (APAAN) and
its salts, optical isomers, and salts of optical isomers whose
application for exemption is subsequently denied by the DEA must obtain
a registration with the DEA. A temporary exemption from the registration
requirement will also be provided for those persons whose applications
for exemption are denied, provided that the 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 the DEA takes final action on their registration
application.
(o)(1) 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-(1-benzylpiperidin-4-yl)-N-phenylpropionamide
(benzylfentanyl) and its salts, 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 benzylfentanyl pursuant to Sec. 1310.13 on or before May 15,
2020. 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 N-(1-benzylpiperidin-4-yl)-N-
phenylpropionamide (benzylfentanyl) 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 application for exemption is 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.
(p)(1) 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-phenylpiperidin-4-amine (4-anilinopiperidine; N-phenyl-4-
piperidinamine, 4-AP) and its amides, its carbamates, and its salts,
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 4-anilinopiperidine pursuant
to Sec. 1310.13 on or before May 15, 2020. 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 N-phenylpiperidin-4-amine (4-
anilinopiperidine; N-phenyl-4-
[[Page 178]]
piperidinamine; 4-AP) and its amides, its carbamates, 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
application for exemption is 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.
(q)(1) Each person required under 21 U.S.C. 822 and 957 to obtain a
registration to manufacture, distribute, import, or export regulated
forms of 3,4-MDP-2-P methyl glycidate (PMK glycidate), 3,4-MDP-2-P
methyl glycidic acid (PMK glycidic acid), and alpha-phenylacetoacetamide
(APAA), 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 regulated
forms of 3,4-MDP-2-P methyl glycidate (PMK glycidate), 3,4-MDP-2-P
methyl glycidic acid (PMK glycidic acid), or alpha-phenylacetoacetamide
(APAA) pursuant to Sec. 1310.13 on or before (30 days after publication
of a rule implementing regulations regarding these three chemicals). 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 regulated forms of 3,4-MDP-2-P methyl
glycidate (PMK glycidate), 3,4-MDP-2-P methyl glycidic acid (PMK
glycidic acid), or alpha-phenylacetoacetamide (APAA) 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.
(r)(1) Each person required under 21 U.S.C. 822 and 957 to obtain a
registration to manufacture, distribute, import, or export regulated
forms of methyl alpha-phenylacetoacetate (MAPA; methyl 3-oxo-2-
phenylbutanoate) and its optical isomers, 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 regulated forms of MAPA pursuant to Sec.
1310.13 on or before December 20, 2021. The exemption would 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 regulated forms of methyl alpha-
phenylacetoacetate (MAPA; methyl 3-oxo-2-phenylbutanoate) and its
optical isomers whose application for exemption is subsequently denied
by DEA must obtain a registration with DEA. A temporary exemption from
the registration requirement would also be provided for those persons
whose application for exemption is 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
would remain in effect
[[Page 179]]
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; 82 FR 32460, July 14,
2017; 85 FR 20828, Apr. 15, 2020; 86 FR 24707, May 7, 2021; 86 FR 64366,
Nov. 18, 2021]
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 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.
[[Page 180]]
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]