21 U.S. Code § 802 - Definitions | U.S. Code | US Law | LII / Legal Information Institute

21 U.S. Code § 802 - Definitions | U.S. Code | US Law | LII / Legal Information Institute
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21 U.S. Code § 802 - Definitions
U.S. Code
Notes
Authorities (CFR)
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As used in this subchapter:
(1)
The term “
addict
” means any individual who habitually uses any
narcotic drug
so as to endanger the public morals, health, safety, or welfare, or who is so far addicted to the use of
narcotic drugs
as to have lost the power of self
-control
with reference to his addiction.
(2)
The term “
administer
” refers to the direct application of a
controlled substance
to the body of a patient or research subject by—
(A)
practitioner
(or, in his presence, by his authorized
agent)
, or
(B)
the patient or research subject at the direction and in the presence of the
practitioner
whether such application be by injection, inhalation, ingestion, or any other means.
(3)
The term “
agent
” means an authorized person who acts on behalf of or at the direction of a
manufacturer
distributor,
or
dispenser;
except that such term does not include a common or contract carrier, public warehouseman, or employee of the carrier or warehouseman, when acting in the usual and lawful course of the carrier’s or warehouseman’s business.
(4)
The term “
Drug Enforcement Administration
” means the
Drug Enforcement Administration
in the
Department of Justice
(5)
The term “
control
” means to add a
drug
or other substance, or
immediate precursor
, to a schedule under part B of this subchapter, whether by transfer from another schedule or otherwise.
(6)
The term “
controlled substance
” means a
drug
or other substance, or
immediate precursor,
included in schedule I, II, III, IV, or V of part B of this subchapter. The term does not include distilled spirits, wine, malt beverages, or tobacco, as those terms are defined or used in subtitle E of the
Internal Revenue Code of 1986
(7)
The term “
counterfeit substance
” means a
controlled substance
which, or the container or labeling of which, without authorization, bears the trademark, trade name, or other identifying mark, imprint, number, or device, or any likeness thereof, of a
manufacturer,
distributor,
or
dispenser
other than the person or persons who in fact manufactured, distributed, or dispensed such substance and which thereby falsely purports or is represented to be the product of, or to have been distributed by, such other
manufacturer,
distributor,
or
dispenser.
(8)
The terms “
deliver
” or “
delivery
” mean the actual, constructive, or attempted transfer of a
controlled substance
or a
listed chemical,
whether or not there exists an agency relationship.
(9)
The term “
depressant or stimulant substance
” means—
(A)
drug
which contains any quantity of barbituric acid or any of the salts of barbituric acid; or
(B)
drug
which contains any quantity of (i) amphetamine or any of its optical
isomers
; (ii) any salt of amphetamine or any salt of an optical
isomer
of amphetamine; or (iii) any substance which the Attorney General, after investigation, has found to be, and by regulation designated as, habit forming because of its stimulant effect on the central nervous system; or
(C)
lysergic acid diethylamide; or
(D)
any
drug
which contains any quantity of a substance which the Attorney General, after investigation, has found to have, and by regulation designated as having, a potential for abuse because of its depressant or stimulant effect on the central nervous system or its hallucinogenic effect.
(10)
The term “
dispense
” means to
deliver
controlled substance
to an
ultimate user
or research subject by, or pursuant to the lawful order of, a
practitioner,
including the prescribing and administering of a
controlled substance
and the packaging, labeling or compounding necessary to prepare the substance for such
delivery.
The term
“dispenser”
means a
practitioner
who so
delivers
controlled substance
to an
ultimate user
or research subject.
(11)
The term “
distribute
” means to
deliver
(other than by administering or dispensing) a
controlled substance
or a
listed chemical.
The term
“distributor”
means a person who so
delivers
controlled substance
or a
listed chemical.
(12)
The term “
drug
” has the meaning given that term by
section 321(g)(1) of this title
(13)
The term “
felony
” means any Federal or
State
offense classified by applicable Federal or
State
law as a
felony
(14)
The term “
isomer
” means the optical
isomer
, except as used in schedule I(c) and schedule II(a)(4). As used in schedule I(c), the term “
isomer
” means any optical, positional, or geometric
isomer
. As used in schedule II(a)(4), the term “
isomer
” means any optical or geometric
isomer
(15)
The term “
manufacture
” means the
production,
preparation, propagation, compounding, or processing of a
drug
or other substance, either directly or indirectly or by extraction from substances of natural origin, or independently by means of chemical synthesis or by a combination of extraction and chemical synthesis, and includes any packaging or repackaging of such substance or labeling or relabeling of its container; except that such term does not include the preparation, compounding, packaging, or labeling of a
drug
or other substance in conformity with applicable
State
or local law by a
practitioner
as an incident to his administration or dispensing of such
drug
or substance in the course of his professional practice. The term
“manufacturer”
means a person who
manufactures
drug
or other substance.
(16)
(A)
Subject to subparagraph (B), the terms “
marihuana
” and
“marijuana”
mean all parts of the plant Cannabis sativa L., whether growing or not; the seeds thereof; the resin extracted from any part of such plant; and every compound,
manufacture
, salt, derivative, mixture, or preparation of such plant, its seeds or resin.
(B)
The terms “
marihuana
” and
“marijuana”
do not include—
(i)
hemp, as defined in section 1639o of title 7; or
(ii)
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.
(17)
The term “
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:
(A)
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.
(B)
Poppy straw
and concentrate of
poppy straw
(C)
Coca leaves, except coca leaves and extracts of coca leaves from which cocaine, ecgonine, and derivatives of ecgonine or their salts have been removed.
(D)
Cocaine, its salts, optical and geometric
isomers
, and salts of
isomers
(E)
Ecgonine, its derivatives, their salts,
isomers
, and salts of
isomers
(F)
Any compound, mixture, or preparation which contains any quantity of any of the substances referred to in subparagraphs (A) through (E).
(18)
The term “
opiate
” or
“opioid”
means any
drug
or other substance having an addiction-forming or addiction-sustaining liability similar to morphine or being capable of conversion into a
drug
having such addiction-forming or addiction-sustaining liability.
(19)
The term “
opium poppy
” means the plant of the species Papaver somniferum L., except the seed thereof.
(20)
The term “
poppy straw
” means all parts, except the seeds, of the
opium poppy
, after mowing.
(21)
The term “
practitioner
” means a physician, dentist, veterinarian, scientific investigator, pharmacy, hospital, or other person licensed, registered, or otherwise permitted, by the
United States
or the jurisdiction in which he practices or does research, to
distribute,
dispense,
conduct research with respect to,
administer,
or use in teaching or chemical analysis, a
controlled substance
in the course of professional practice or research.
(22)
The term “
production
” includes the
manufacture
, planting, cultivation, growing, or harvesting of a
controlled substance
(23)
The term “
immediate precursor
” means a substance—
(A)
which the Attorney General has found to be and by regulation designated as being the principal compound used, or produced primarily for use, in the
manufacture
of a
controlled substance
(B)
which is an immediate chemical intermediary used or likely to be used in the
manufacture
of such
controlled substance
; and
(C)
the
control
of which is necessary to prevent, curtail, or limit the
manufacture
of such
controlled substance
(24)
The term “
Secretary
”, unless the context otherwise indicates, means the
Secretary
of Health and Human Services.
(25)
The term “
serious bodily injury
” means bodily injury which involves—
(A)
a substantial risk of death;
(B)
protracted and obvious disfigurement; or
(C)
protracted loss or impairment of the function of a bodily member, organ, or mental faculty.
(26)
The term “
State
” means a
State
of the
United States
, the District of Columbia, and any commonwealth, territory, or possession of the
United States
(27)
The term “
ultimate user
” means a person who has lawfully obtained, and who possesses, a
controlled substance
for his own use or for the use of a member of his household or for an animal owned by him or by a member of his household.
(28)
The term “
United States
”, when used in a geographic sense, means all places and waters, continental or insular, subject to the jurisdiction of the
United States
(29)
The term “
maintenance treatment
” means the dispensing, for a period in excess of twenty-one days, of a
narcotic drug
in the treatment of an individual for dependence upon heroin or other morphine-like
drugs.
(30)
The term “
detoxification treatment
” means the dispensing, for a period not in excess of one hundred and eighty days, of a
narcotic drug
in decreasing doses to an individual in order 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.
(31)
The term “
Convention on Psychotropic Substances
” means the
Convention on Psychotropic Substances
signed at Vienna, Austria, on
February 21, 1971
; and the term
“Single Convention on Narcotic Drugs”
means the
Single Convention on Narcotic Drugs
signed at New York, New York, on
March 30, 1961
(32)
(A)
Except as provided in subparagraph (C), the term “
controlled substance analogue
” means a substance—
(i)
the chemical structure of which is substantially similar to the chemical structure of a
controlled substance
in schedule I or II;
(ii)
which has a stimulant, depressant, or hallucinogenic effect on the central nervous system that is substantially similar to or greater than the stimulant, depressant, or hallucinogenic effect on the central nervous system of a
controlled substance
in schedule I or II; or
(iii)
with respect to a particular person, which such person represents or intends to have a stimulant, depressant, or hallucinogenic effect on the central nervous system that is substantially similar to or greater than the stimulant, depressant, or hallucinogenic effect on the central nervous system of a
controlled substance
in schedule I or II.
(B)
The designation of gamma butyrolactone or any other chemical as a
listed chemical
pursuant to paragraph (34) or (35) does not preclude a finding pursuant to subparagraph (A) of this paragraph that the chemical is a
controlled substance analogue
(C)
Such term does not include—
(i)
controlled substance
(ii)
any substance for which there is an approved new
drug
application;
(iii)
with respect to a particular person any substance, if an exemption is in effect for investigational use, for that person, under
section 355 of this title
to the extent conduct with respect to such substance is pursuant to such exemption; or
(iv)
any substance to the extent not intended for human consumption before such an exemption takes effect with respect to that substance.
(33)
The term “
listed chemical
” means any
list I chemical
or any
list II chemical
(34)
The term “
list I chemical
” means a chemical specified by regulation of the Attorney General as a chemical that is used in manufacturing a
controlled substance
in violation of this subchapter and is important to the
manufacture
of the
controlled substances
, and such term includes (until otherwise specified by regulation of the Attorney General, as considered appropriate by the Attorney General or upon petition to the Attorney General by any person) the following:
(A)
Anthranilic acid, its esters, and its salts.
(B)
Benzyl cyanide.
(C)
Ephedrine, its salts, optical
isomers
, and salts of optical
isomers
(D)
Ergonovine and its salts.
(E)
Ergotamine and its salts.
(F)
N-Acetylanthranilic acid, its esters, and its salts.
(G)
Norpseudoephedrine, its salts, optical
isomers
, and salts of optical
isomers
(H)
Phenylacetic acid, its esters, and its salts.
(I)
Phenylpropanolamine, its salts, optical
isomers
, and salts of optical
isomers
(J)
Piperidine and its salts.
(K)
Pseudoephedrine, its salts, optical
isomers
, and salts of optical
isomers
(L)
3,4-Methylenedioxyphenyl-2-propanone.
(M)
Methylamine.
(N)
Ethylamine.
(O)
Propionic anhydride.
(P)
Isosafrole.
(Q)
Safrole.
(R)
Piperonal.
(S)
N-Methylephedrine.
(T)
N-methylpseudoephedrine.
(U)
Hydriodic acid.
(V)
Benzaldehyde.
(W)
Nitroethane.
(X)
Gamma butyrolactone.
(Y)
Any salt, optical
isomer
, or salt of an optical
isomer
of the chemicals listed in subparagraphs (M) through (U) of this paragraph.
(35)
The term “
list II chemical
” means a chemical (other than a
list I chemical)
specified by regulation of the Attorney General as a chemical that is used in manufacturing a
controlled substance
in violation of this subchapter, and such term includes (until otherwise specified by regulation of the Attorney General, as considered appropriate by the Attorney General or upon petition to the Attorney General by any person) the following chemicals:
(A)
Acetic anhydride.
(B)
Acetone.
(C)
Benzyl chloride.
(D)
Ethyl ether.
(E)
Repealed.
Pub. L. 101–647, title XXIII, § 2301(b)
Nov. 29, 1990
104 Stat. 4858
(F)
Potassium permanganate.
(G)
2-Butanone (or Methyl Ethyl Ketone).
(H)
Toluene.
(I)
Iodine.
(J)
Hydrochloric gas.
(36)
The term “
regular customer
” means, with respect to a
regulated person
, a customer with whom the
regulated person
has an established business relationship that is reported to the Attorney General.
(37)
The term “
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 Attorney General.
(38)
The term “
regulated person
” means a person 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,
a tableting machine, or an encapsulating machine.
(39)
The term “
regulated transaction
” means—
(A)
a distribution, receipt, sale, importation, or exportation of, or an
international transaction
involving shipment of, a
listed chemical,
or if the Attorney General establishes a threshold amount for a specific
listed chemical,
a threshold amount, including a cumulative threshold amount for multiple transactions (as determined by the Attorney General, in consultation with the chemical industry and taking into consideration the quantities normally used for lawful purposes), 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
(ii)
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 clause does not relieve a
distributor,
importer, or exporter from compliance with
section 830 of this title
(iii)
any category of transaction or any category of transaction for a specific
listed chemical
or chemicals specified by regulation of the Attorney General as excluded from this definition as unnecessary for enforcement of this subchapter or subchapter II;
(iv)
any transaction in a
listed chemical
that is contained in a
drug
that may be marketed or distributed lawfully in the
United States
under the Federal
Food, Drug, and Cosmetic Act
21 U.S.C. 301
et seq.], subject to clause (v), unless—
(I)
the Attorney General has determined under
section 814 of this title
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
(II)
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 by the Attorney General;
(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
section 830(b)(3) of this title
; or
(vi)
any transaction in a
chemical mixture
which the Attorney General has by regulation designated as exempt from the application of this subchapter and subchapter II based on a finding that the mixture is formulated in such a way that it cannot be easily used in the illicit
production
of a
controlled substance
and that the
listed chemical
or chemicals contained in the mixture cannot be readily recovered; and
(B)
a distribution, importation, or exportation of a tableting machine or encapsulating machine.
(40)
The term “
chemical mixture
” means a combination of two or more chemical substances, at least one of which is not a
list I chemical
or a
list II chemical,
except that such term does not include any combination of a
list I chemical
or a
list II chemical
with another chemical that is present solely as an impurity.
(41)
(A)
The term “
anabolic steroid
” means any
drug
or hormonal substance, chemically and pharmacologically related to testosterone (other than estrogens, progestins, corticosteroids, and dehydroepiandrosterone), and includes—
(i)
androstanediol—
(I)
3β,17β-dihydroxy-5α-androstane; and
(II)
3α,17β-dihydroxy-5α-androstane;
(ii)
androstanedione (5α-androstan-3,17-dione);
(iii)
androstenediol—
(I)
1-androstenediol (3β,17β-dihydroxy-5α-androst-1-ene);
(II)
1-androstenediol (3α,17β-dihydroxy-5α-androst-1-ene);
(III)
4-androstenediol (3β,17β-dihydroxy-androst-4-ene); and
(IV)
5-androstenediol (3β,17β-dihydroxy-androst-5-ene);
(iv)
androstenedione—
(I)
1-androstenedione ([5α]-androst-1-en-3,17-dione);
(II)
4-androstenedione (androst-4-en-3,17-dione); and
(III)
5-androstenedione (androst-5-en-3,17-dione);
(v)
bolasterone (7α,17α-dimethyl-17β-hydroxyandrost-4-en-3-one);
(vi)
boldenone (17β-hydroxyandrost-1,4,-diene-3-one);
(vii)
calusterone (7β,17α-dimethyl-17β-hydroxyandrost-4-en-3-one);
(viii)
clostebol (4-chloro-17β-hydroxyandrost-4-en-3-one);
(ix)
dehydrochloromethyltestosterone (4-chloro-17β-hydroxy-17α-methyl-androst-1,4-dien-3-one);
(x)
*1-dihydrotestosterone (a.k.a. “1-testosterone”) (17β-hydroxy-5α-androst-1-en-3-one);
(xi)
4-dihydrotestosterone (17β-hydroxy-androstan-3-one);
(xii)
drostanolone (17β-hydroxy-2α-methyl-5α-androstan-3-one);
(xiii)
ethylestrenol (17α-ethyl-17β-hydroxyestr-4-ene);
(xiv)
fluoxymesterone (9-fluoro-17α-methyl-11β,17β-dihydroxyandrost-4-en-3-one);
(xv)
formebolone (2-formyl-17α-methyl-11α,17β-dihydroxyandrost-1,4-dien-3-one);
(xvi)
furazabol (17α-methyl-17β-hydroxyandrostano[2,3-c]-furazan);
(xvii)
13β-ethyl-17β-hydroxygon-4-en-3-one;
(xviii)
4-hydroxytestosterone (4,17β-dihydroxy-androst-4-en-3-one);
(xix)
4-hydroxy-19-nortestosterone (4,17β-dihydroxy-estr-4-en-3-one);
(xx)
mestanolone (17α-methyl-17β-hydroxy-5α-androstan-3-one);
(xxi)
mesterolone (1α-methyl-17β-hydroxy-[5α]-androstan-3-one);
(xxii)
methandienone (17α-methyl-17β-hydroxyandrost-1,4-dien-3-one);
(xxiii)
methandriol (17α-methyl-3β,17β-dihydroxyandrost-5-ene);
(xxiv)
methenolone (1-methyl-17β-hydroxy-5α-androst-1-en-3-one);
(xxv)
17α-methyl-3β, 17β-dihydroxy-5α-androstane;
(xxvi)
17α-methyl-3α,17β-dihydroxy-5α-androstane;
(xxvii)
17α-methyl-3β,17β-dihydroxyandrost-4-ene.
(xxviii)
17α-methyl-4-hydroxynandrolone (17α-methyl-4-hydroxy-17β-hydroxyestr-4-en-3-one);
(xxix)
methyldienolone (17α-methyl-17β-hydroxyestra-4,9(10)-dien-3-one);
(xxx)
methyltrienolone (17α-methyl-17β-hydroxyestra-4,9-11-trien-3-one);
(xxxi)
methyltestosterone (17α-methyl-17β-hydroxyandrost-4-en-3-one);
(xxxii)
mibolerone (7α,17α-dimethyl-17β-hydroxyestr-4-en-3-one);
(xxxiii)
17α-methyl-*1-dihydrotestosterone (17β-hydroxy-17α-methyl-5α-androst-1-en-3-one) (a.k.a. “17-α-methyl-1-testosterone”);
(xxxiv)
nandrolone (17β-hydroxyestr-4-en-3-one);
(xxxv)
norandrostenediol—
(I)
19-nor-4-androstenediol (3β, 17β-dihydroxyestr-4-ene);
(II)
19-nor-4-androstenediol (3α, 17β-dihydroxyestr-4-ene);
(III)
19-nor-5-androstenediol (3β, 17β-dihydroxyestr-5-ene); and
(IV)
19-nor-5-androstenediol (3α, 17β-dihydroxyestr-5-ene);
(xxxvi)
norandrostenedione—
(I)
19-nor-4-androstenedione (estr-4-en-3,17-dione); and
(II)
19-nor-5-androstenedione (estr-5-en-3,17-dione;
(xxxvii)
norbolethone (13β,17α-diethyl-17β-hydroxygon-4-en-3-one);
(xxxviii)
norclostebol (4-chloro-17β-hydroxyestr-4-en-3-one);
(xxxix)
norethandrolone (17α-ethyl-17β-hydroxyestr-4-en-3-one);
(xl)
normethandrolone (17α-methyl-17β-hydroxyestr-4-en-3-one);
(xli)
oxandrolone (17α-methyl-17β-hydroxy-2-oxa-[5α]-androstan-3-one);
(xlii)
oxymesterone (17α-methyl-4,17β-dihydroxyandrost-4-en-3-one);
(xliii)
oxymetholone (17α-methyl-2-hydroxymethylene-17β-hydroxy-[5α]-androstan-3-one);
(xliv)
stanozolol (17α-methyl-17β-hydroxy-[5α]-androst-2-eno[3,2-c]-pyrazole);
(xlv)
stenbolone (17β-hydroxy-2-methyl-[5α]-androst-1-en-3-one);
(xlvi)
testolactone (13-hydroxy-3-oxo-13,17-secoandrosta-1,4-dien-17-oic acid lactone);
(xlvii)
testosterone (17β-hydroxyandrost-4-en-3-one);
(xlviii)
tetrahydrogestrinone (13β,17α-diethyl-17β-hydroxygon-4,9,11-trien-3-one);
(xlix)
trenbolone (17β-hydroxyestr-4,9,11-trien-3-one);
(l)
5α-Androstan-3,6,17-trione;
(li)
6-bromo-androstan-3,17-dione;
(lii)
6-bromo-androsta-1,4-diene-3,17-dione;
(liii)
4-chloro-17α-methyl-androsta-1,4-diene-3,17β-diol;
(liv)
4-chloro-17α-methyl-androst-4-ene-3β,17β-diol;
(lv)
4-chloro-17α-methyl-17β-hydroxy-androst-4-en-3-one;
(lvi)
4-chloro-17α-methyl-17β-hydroxy-androst-4-ene-3,11-dione;
(lvii)
4-chloro-17α-methyl-androsta-1,4-diene-3,17β-diol;
(lviii)
2α,17α-dimethyl-17β-hydroxy-5α-androstan-3-one;
(lix)
2α,17α-dimethyl-17β-hydroxy-5β-androstan-3-one;
(lx)
2α,3α-epithio-17α-methyl-5α-androstan-17β-ol;
(lxi)
[3,2-c]-furazan-5α-androstan-17β-ol;
(lxii)
3β-hydroxy-estra-4,9,11-trien-17-one;
(lxiii)
17α-methyl-androst-2-ene-3,17β-diol;
(lxiv)
17α-methyl-androsta-1,4-diene-3,17β-diol;
(lxv)
Estra-4,9,11-triene-3,17-dione;
(lxvi)
18a-Homo-3-hydroxy-estra-2,5(10)-dien-17-one;
(lxvii)
6α-Methyl-androst-4-ene-3,17-dione;
(lxviii)
17α-Methyl-androstan-3-hydroxyimine-17β-ol;
(lxix)
17α-Methyl-5α-androstan-17β-ol;
(lxx)
17β-Hydroxy-androstano[2,3-d]isoxazole;
(lxxi)
17β-Hydroxy-androstano[3,2-c]isoxazole;
(lxxii)
4-Hydroxy-androst-4-ene-3,17-dione[3,2-c]pyrazole-5α-androstan-17β-ol;
(lxxiii)
[3,2-c]pyrazole-androst-4-en-17β-ol;
(lxxiv)
[3,2-c]pyrazole-5α-androstan-17β-ol; and
(lxxv)
any salt, ester, or ether of a
drug
or substance described in this paragraph.
The substances excluded under this subparagraph may at any time be scheduled by the Attorney General in accordance with the authority and requirements of subsections (a) through (c) of
section 811 of this title
(B)
(i)
Except as provided in clause (ii), such term does not include an
anabolic steroid
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.
(ii)
If any person prescribes,
dispenses
, or
distributes
such steroid for human use, such person shall be considered to have prescribed, dispensed, or distributed an
anabolic steroid
within the meaning of subparagraph (A).
(C)
(i)
Subject to clause (ii), a
drug
or hormonal substance (other than estrogens, progestins, corticosteroids, and dehydroepiandrosterone) that is not listed in subparagraph (A) and is derived from, or has a chemical structure substantially similar to, 1 or more
anabolic steroids
listed in subparagraph (A) shall be considered to be an
anabolic steroid
for purposes of this chapter if—
(I)
the
drug
or substance has been created or manufactured with the intent of producing a
drug
or other substance that either—
(aa)
promotes muscle growth; or
(bb)
otherwise causes a pharmacological effect similar to that of testosterone; or
(II)
the
drug
or substance has been, or is intended to be, marketed or otherwise promoted in any manner suggesting that consuming it will promote muscle growth or any other pharmacological effect similar to that of testosterone.
(ii)
A substance shall not be considered to be a
drug
or hormonal substance for purposes of this subparagraph if it—
(I)
is—
(aa)
an herb or other botanical;
(bb)
a concentrate, metabolite, or extract of, or a constituent isolated directly from, an herb or other botanical; or
(cc)
a combination of 2 or more substances described in item (aa) or (bb);
(II)
is a dietary ingredient for purposes of the Federal
Food, Drug, and Cosmetic Act
21 U.S.C. 301
et seq.); and
(III)
is not anabolic or androgenic.
(iii)
In accordance with
section 885(a) of this title
, any person claiming the benefit of an exemption or exception under clause (ii) shall bear the burden of going forward with the evidence with respect to such exemption or exception.
(42)
The term “
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.
(43)
The terms “
broker
” and “
trader
” mean a person that assists in arranging an
international transaction
in a
listed chemical
by—
(A)
negotiating contracts;
(B)
serving as an
agent
or intermediary; or
(C)
bringing together a buyer and seller, a buyer and transporter, or a seller and transporter.
(44)
The term “
felony drug offense
” means an offense that is punishable by imprisonment for more than one year under any law of the
United States
or of a
State
or foreign country that prohibits or restricts conduct relating to
narcotic drugs,
marihuana,
anabolic steroids
, or
depressant or stimulant substances.
(45)
(A)
The term “
scheduled listed chemical product
” means, subject to subparagraph (B), a product that—
(i)
contains ephedrine, pseudoephedrine, or phenylpropanolamine; and
(ii)
may be marketed or distributed lawfully in the
United States
under the Federal,
Food, Drug, and Cosmetic Act
21 U.S.C. 301
et seq.] as a nonprescription
drug.
Each reference in clause (i) to ephedrine, pseudoephedrine, or phenylpropanolamine includes each of the salts, optical
isomers
, and salts of optical
isomers
of such chemical.
(B)
Such term does not include a product described in subparagraph (A) if the product contains a chemical specified in such subparagraph that the Attorney General has under
section 811(a) of this title
added to any of the schedules under
section 812(c) of this title
. In the absence of such scheduling by the Attorney General, a chemical specified in such subparagraph may not be considered to be a
controlled substance.
(46)
The term “
regulated seller
” means a
retail distributor
(including a pharmacy or a
mobile retail vendor)
, except that such term does not include an employee or
agent
of such
distributor.
(47)
The term “
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).
(48)
The term “
at retail
”, with respect to the sale or purchase of a
scheduled listed chemical product
, means a sale or purchase for personal use, respectively.
(49)
(A)
The term “
retail distributor
” means a grocery store, general merchandise store,
drug
store, or other entity or person whose activities as a
distributor
relating to ephedrine, pseudoephedrine, or phenylpropanolamine products 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.
(B)
For purposes of this paragraph, entities are defined by reference to the Standard Industrial Classification (SIC) code, as follows:
(i)
A grocery store is an entity within SIC code 5411.
(ii)
A general merchandise store is an entity within SIC codes 5300 through 5399 and 5499.
(iii)
drug
store is an entity within SIC code 5912.
(50)
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.
(51)
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.
(52)
The term “
online pharmacy
”—
(A)
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,
controlled substance
by means of the
Internet;
and
(B)
does not include—
(i)
manufacturers
or
distributors
registered under subsection (a), (b), (e), or (f) of
section 823 of this title
who do not dispense
controlled substances
to an unregistered individual or entity;
(ii)
nonpharmacy
practitioners
who are registered under
section 823(g) of this title
and whose activities are authorized by that registration;
(iii)
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 823(g) of this title
(iv)
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
25 U.S.C. 5301
et seq.];
(v)
any
agent
or employee of any hospital or facility referred to in clause (iii) or (iv), 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 clause (iv), only to the extent such individuals are furnishing services pursuant to the contracts or compacts described in such clause;
(vi)
mere advertisements that do not attempt to facilitate an actual transaction involving a
controlled substance
(vii)
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;
(viii)
a pharmacy registered under
section 823(g) of this title
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 (55); or
(II)
filling new prescriptions for controlled substances in schedule III, IV, or V
, as defined in paragraph (56); or
(ix)
any other persons for whom the Attorney General and the
Secretary
have jointly, by regulation, found it to be consistent with effective
controls
against diversion and otherwise consistent with the public health and safety to exempt from the definition of an “
online pharmacy
”.
(53)
The term “
homepage
” means the opening or main page or screen of the website of an
online pharmacy
that is viewable on the
Internet.
(54)
The term “
practice of telemedicine
” means, for purposes of this subchapter, 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 1395m(m) of title 42
, which practice—
(A)
is being conducted—
(i)
while the patient is being treated by, and physically located in, a hospital or clinic registered under
section 823(g) of this title
; and
(ii)
by a
practitioner
(I)
acting in the usual course of professional practice;
(II)
acting in accordance with applicable
State
law; and
(III)
registered under
section 823(g) of this title
in the
State
in which the patient is located, unless the
practitioner—
(aa)
is exempted from such registration in all
States
under
section 822(d) of this title
; or
(bb)
is—
(AA)
an employee or contractor of the
Department of Veterans Affairs
who is acting in the scope of such employment or contract; and
(BB)
registered under
section 823(g) of this title
in any
State
or is utilizing the registration of a hospital or clinic operated by the
Department of Veterans Affairs
registered under
section 823(g) of this title
(B)
is being conducted while the patient is being treated by, and in the physical presence of, a
practitioner
(i)
acting in the usual course of professional practice;
(ii)
acting in accordance with applicable
State
law; and
(iii)
registered under
section 823(g) of this title
in the
State
in which the patient is located, unless the
practitioner—
(I)
is exempted from such registration in all
States
under
section 822(d) of this title
; or
(II)
is—
(aa)
an employee or contractor of the
Department of Veterans Affairs
who is acting in the scope of such employment or contract; and
(bb)
registered under
section 823(g) of this title
in any
State
or is using the registration of a hospital or clinic operated by the
Department of Veterans Affairs
registered under
section 823(g) of this title
(C)
is being conducted by a
practitioner
(i)
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
25 U.S.C. 5301
et seq.];
(ii)
acting within the scope of the employment, contract, or compact described in clause (i); and
(iii)
who is designated as an
Internet
Eligible
Controlled Substances
Provider by the
Secretary
under
section 831(g)(2) of this title
(D)
(i)
is being conducted during a public health emergency declared by the
Secretary
under
section 247d of title 42
; and
(ii)
involves patients located in such areas, and such
controlled substances
, as the
Secretary,
with the concurrence of the Attorney General, designates, provided that such designation shall not be subject to the procedures prescribed by subchapter II of chapter 5 of title 5;
(E)
is being conducted by a
practitioner
who has obtained from the Attorney General a special registration under
section 831(h) of this title
(F)
is being conducted—
(i)
in a medical emergency situation—
(I)
that prevents the patient from being in the physical presence of a
practitioner
registered under
section 823(g) of this title
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;
(II)
that prevents the patient from being physically present at a hospital or clinic operated by the
Department of Veterans Affairs
registered under
section 823(g) of this title
(III)
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
(IV)
that requires immediate intervention by a health care
practitioner
using
controlled substances
to prevent what the
practitioner
reasonably believes in good faith will be imminent and serious clinical consequences, such as further injury or death; and
(ii)
by a
practitioner
that—
(I)
is an employee or contractor of the Veterans Health Administration acting within the scope of that employment or contract;
(II)
is registered under
section 823(g) of this title
in any
State
or is utilizing the registration of a hospital or clinic operated by the
Department of Veterans Affairs
registered under
section 823(g) of this title
; and
(III)
issues a
controlled substance
prescription in this emergency context that is limited to a maximum of a 5-day supply which may not be extended or refilled; or
(G)
is being conducted under any other circumstances that the Attorney General and the
Secretary
have jointly, by regulation, determined to be consistent with effective
controls
against diversion and otherwise consistent with the public health and safety.
(55)
The term “
refilling prescriptions for controlled substances in schedule III, IV, or V
”—
(A)
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 829 of this title
, as appropriate; and
(B)
does not include the issuance of a new prescription to an individual for a
controlled substance
that individual was previously prescribed.
(56)
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—
(A)
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 829 of this title
(in this paragraph referred to as the “original prescription”);
(B)
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 subparagraph (A); and
(C)
the
practitioner
, acting in the usual course of professional practice, determines there is a legitimate medical purpose for the issuance of the new prescription.
(57)
The term “suspicious order” may include, but is not limited to—
(A)
an order of a
controlled substance
of unusual size;
(B)
an order of a
controlled substance
deviating substantially from a normal pattern; and
(C)
orders of
controlled substances
of unusual frequency.
(58)
The term “
serious drug felony
” means an offense described in
section 924(e)(2) of title 18
for which—
(A)
the offender served a term of imprisonment of more than 12 months; and
(B)
the offender’s release from any term of imprisonment was within 15 years of the commencement of the instant offense.
(59)
The term “
serious violent felony
” means—
(A)
an offense described in
section 3559(c)(2) of title 18
for which the offender served a term of imprisonment of more than 12 months; and
(B)
any offense that would be a
felony
violation of
section 113 of title 18
, if the offense were committed in the special maritime and territorial jurisdiction of the
United States,
for which the offender served a term of imprisonment of more than 12 months.
(60)
The term “
fentanyl-related substance
” has the meaning given the term in subsection (e)(2) of schedule I of
section 812(c) of this title
Pub. L. 91–513, title II, § 102
Oct. 27, 1970
84 Stat. 1242
Pub. L. 93–281, § 2
May 14, 1974
88 Stat. 124
Pub. L. 95–633, title I, § 102(b)
Nov. 10, 1978
92 Stat. 3772
Pub. L. 96–132, § 16(a)
Nov. 30, 1979
93 Stat. 1049
Pub. L. 98–473, title II, § 507(a)
, (b),
Oct. 12, 1984
98 Stat. 2071
Pub. L. 98–509, title III, § 301(a)
Oct. 19, 1984
98 Stat. 2364
Pub. L. 99–514, § 2
Oct. 22, 1986
100 Stat. 2095
Pub. L. 99–570, title I
, §§ 1003(b), 1203, 1870,
Oct. 27, 1986
100 Stat. 3207–6
, 3207–13, 3207–56;
Pub. L. 99–646, § 83
Nov. 10, 1986
100 Stat. 3619
Pub. L. 100–690, title VI, § 6054
Nov. 18, 1988
102 Stat. 4316
Pub. L. 101–647, title XIX, § 1902(b)
, title XXIII, § 2301, title XXXV, § 3599I,
Nov. 29, 1990
104 Stat. 4852
, 4858, 4932;
Pub. L. 103–200
, §§ 2(a), 7–9(a),
Dec. 17, 1993
107 Stat. 2333
, 2340;
Pub. L. 103–322, title IX, § 90105(d)
, title XXXIII, § 330024(a), (b), (d)(1),
Sept. 13, 1994
108 Stat. 1988
, 2150;
Pub. L. 104–237, title II
, §§ 204(a), 209, title IV, § 401(a), (b),
Oct. 3, 1996
110 Stat. 3102
, 3104, 3106, 3107;
Pub. L. 104–294, title VI
, §§ 604(b)(4), 607(j),
Oct. 11, 1996
110 Stat. 3506
, 3512;
Pub. L. 105–115, title I, § 126(c)(3)
Nov. 21, 1997
111 Stat. 2328
Pub. L. 106–172
, §§ 3(c), 5(a),
Feb. 18, 2000
114 Stat. 9
, 10;
Pub. L. 106–310, div. B, title XXXVI, § 3622(a)
Oct. 17, 2000
114 Stat. 1231
Pub. L. 107–273, div. B, title IV, § 4002(c)(1)
Nov. 2, 2002
116 Stat. 1808
Pub. L. 108–358, § 2(a)
Oct. 22, 2004
118 Stat. 1661
Pub. L. 109–162, title XI, § 1180
Jan. 5, 2006
119 Stat. 3126
Pub. L. 109–177, title VII
, §§ 711(a)(1), (2)(A), 712(a)(1),
Mar. 9, 2006
120 Stat. 256
, 257, 263;
Pub. L. 110–425, § 3(a)
Oct. 15, 2008
122 Stat. 4821
Pub. L. 113–260, § 2(a)
Dec. 18, 2014
128 Stat. 2929
Pub. L. 114–198, title III, § 303(a)(2)
July 22, 2016
130 Stat. 722
Pub. L. 115–271, title III
, §§ 3202(c), 3292(a),
Oct. 24, 2018
132 Stat. 3945
, 3956;
Pub. L. 115–334, title XII, § 12619(a)
Dec. 20, 2018
132 Stat. 5018
Pub. L. 115–391, title IV, § 401(a)(1)
Dec. 21, 2018
132 Stat. 5220
Pub. L. 117–215, § 2(b)
, title I, § 103(b)(1)(A),
Dec. 2, 2022
136 Stat. 2258
, 2262;
Pub. L. 118–189, § 1
Dec. 23, 2024
138 Stat. 2652
Pub. L. 119–26, § 6(c)
July 16, 2025
139 Stat. 417
.)
Editorial Notes
References in Text
Schedules I, II, III, IV, and V, referred to in pars. (6), (14), (32)(A), (52)(B)(viii), (55), and (56), are set out in
section 812(c) of this title
This subchapter, referred to in introductory provisions and in pars. (34), (35), (39)(A)(iii), (vi), and (54), was in the original “this title”, meaning title II of
Pub. L. 91–513
Oct. 27, 1970
84 Stat. 1242
, and is popularly known as the “
Controlled Substances Act
”. For complete classification of title II to the Code, see second paragraph of Short Title note set out under
section 801 of this title
and Tables.
Subchapter II, referred to in par. (39)(A)(iii), (vi), was in the original “title III”, meaning title III of
Pub. L. 91–513
Oct. 27, 1970
84 Stat. 1285
. Part A of title III comprises subchapter II of this chapter. For classification of Part B, consisting of sections 1101 to 1105 of title III, see Tables.
The Federal
Food, Drug, and Cosmetic Act
, referred to in pars. (39)(A)(iv), (41)(C)(ii)(II), and (45)(A)(ii), is act June 25, 1938, ch. 675,
52 Stat. 1040
, which is classified generally to chapter 9 (§ 301 et seq.) of this title. For complete classification of this Act to the Code, see
section 301 of this title
and Tables.
This chapter, referred to in par. (41)(C)(i), was in the original “this Act”, meaning
Pub. L. 91–513
Oct. 27, 1970
84 Stat. 1236
. For complete classification of this Act to the Code, see Short Title note set out under
section 801 of this title
and Tables.
The
Indian Self-Determination and Education Assistance Act
, referred to in pars. (52)(B)(iv) and (54)(C)(i), is
Pub. L. 93–638
Jan. 4, 1975
88 Stat. 2203
, which is classified principally to chapter 46 (§ 5301 et seq.) of Title 25, Indians. For complete classification of this Act to the Code, see Short Title note set out under
section 5301 of Title 25
and Tables.
Amendments
2025—Par. (60).
Pub. L. 119–26
added par. (60).
2024—Pars. (57) to (59).
Pub. L. 118–189
redesignated pars. (57) defining the term
“serious drug felony”
and (58) as (58) and (59), respectively, and realigned margins.
2022—Par. (16)(A).
Pub. L. 117–215, § 2(b)(1)
, substituted “the terms
‘marihuana’
and
‘marijuana’
mean” for “the term
‘marihuana’
means”.
Par. (16)(B).
Pub. L. 117–215, § 2(b)(2)
, substituted “The terms
‘marihuana’
and
‘marijuana’
do not” for “The term
‘marihuana’
does not” in introductory provisions.
Par. (52)(B).
Pub. L. 117–215, § 103(b)(1)(A)(i)(I)
, substituted “823(g)” for “823(f)” wherever appearing.
Par. (52)(B)(i).
Pub. L. 117–215, § 103(b)(1)(A)(i)(II)
, substituted “(e), or (f)” for “(d), or (e)”.
Par. (54).
Pub. L. 117–215, § 103(b)(1)(A)(ii)
, substituted “823(g)” for “823(f)” wherever appearing.
2018—Par. (16).
Pub. L. 115–334
designated first sentence as subpar. (A), substituted “Subject to subparagraph (B), the” for “The”, inserted subpar. (B) designation, introductory provisions, and cl. (i), designated second sentence as cl. (ii) of subpar. (B), and substituted “the” for “Such term does not include the” in cl. (ii).
Par. (24).
Pub. L. 115–271, § 3202(c)
, substituted “Health and Human Services” for “Health, Education, and Welfare”.
Par. (57).
Pub. L. 115–391, § 401(a)(1)
, added par. (57) defining the term
“serious drug felony”
Pub. L. 115–271, § 3292(a)
, added par. (57) defining the term “suspicious order”.
Par. (58).
Pub. L. 115–391, § 401(a)(1)
, added par. (58).
2016—Par. (18).
Pub. L. 114–198
inserted “or
‘opioid’
” after “The term
‘opiate’
”.
2014—Par. (41)(A)(l) to (lxxv).
Pub. L. 113–260, § 2(a)(1)
, added cls. (l) to (lxxiv) and redesignated former cl. (xlx) as (lxxv).
Par. (41)(C).
Pub. L. 113–260, § 2(a)(2)
, added subpar. (C).
2008—Pars. (50) to (56).
Pub. L. 110–425
added pars. (50) to (56).
2006—Par. (39)(A)(iv).
Pub. L. 109–177, § 712(a)(1)(A)(i)
, amended cl. (iv) generally. Prior to amendment, cl. (iv) related to transactions involving
drugs
containing ephedrine, pseudoephedrine, or phenylpropanolamine.
Par. (39)(A)(v), (vi).
Pub. L. 109–177, § 712(a)(1)(A)(ii)
, (iii), added cl. (v) and redesignated former cl. (v) as (vi).
Par. (41)(A)(xvii).
Pub. L. 109–162, § 1180(1)
, substituted “13β-ethyl-17β-hydroxygon-4-en-3-one;” for “13β-ethyl-17α-hydroxygon-4-en-3-one;”.
Par. (41)(A)(xliv).
Pub. L. 109–162, § 1180(2)
, substituted “(17α-methyl-17β-hydroxy-[5α]-androst-2-eno[3,2-c]-pyrazole);” for “(17α-methyl-17α-hydroxy-[5α]-androst-2-eno[3,2-c]-pyrazole);”.
Par. (45).
Pub. L. 109–177
, §§ 711(a)(1)(B), 712(a)(1)(B), added par. (45) and struck out former par. (45) which defined “ordinary over-the-counter pseudoephedrine or phenylpropanolamine product”.
Pars. (46) to (48).
Pub. L. 109–177
, §§ 711(a)(1)(B), added pars. (46) to (48). Former par. (46) redesignated (49).
Par. (49).
Pub. L. 109–177, § 711(a)(1)(A)
, (2)(A), redesignated par. (46) as (49), substituted “ephedrine, pseudoephedrine, or” for “pseudoephedrine or” in subpar. (A), redesignated subpar. (C) as (B), and struck out former subpar. (B) which read as follows: “For purposes of this paragraph, sale for personal use means the sale of below-threshold quantities in a single transaction to an individual for legitimate medical use.”
2004—Par. (41).
Pub. L. 108–358, § 2(a)(1)
, realigned margins, added subpar. (A), and struck out former subpar. (A) which defined
“anabolic steroid”
Par. (44).
Pub. L. 108–358, § 2(a)(2)
, inserted
“anabolic steroids,
” after
“marihuana,
”.
2002—Pars. (43), (44).
Pub. L. 107–273
repealed
Pub. L. 104–294
, §§ 604(b)(4), 607(j)(2). See 1996 Amendment note below.
2000—Par. (32)(A).
Pub. L. 106–172, § 5(a)(1)
, substituted “subparagraph (C)” for “subparagraph (B)” in introductory provisions.
Par. (32)(B), (C).
Pub. L. 106–172, § 5(a)(2)
, (3), added subpar. (B) and redesignated former subpar. (B) as (C).
Par. (34)(X), (Y).
Pub. L. 106–172, § 3(c)
, added subpar. (X) and redesignated former subpar. (X) as (Y).
Par. (39)(A)(iv)(II).
Pub. L. 106–310
substituted “9 grams” for “24 grams” in two places and inserted before semicolon at end “and sold in package sizes of not more than 3 grams of pseudoephedrine base or 3 grams of phenylpropanolamine base”.
1997—Par. (9)(A).
Pub. L. 105–115
redesignated cl. (i) as subpar. (A) and struck out cl. (ii) which read as follows: “any derivative of barbituric acid which has been designated by the
Secretary
as habit forming under
section 352(d) of this title
; or”.
1996—Par. (26).
Pub. L. 104–294, § 607(j)(1)
, amended par. (26) generally. Prior to amendment, par. (26) read as follows: “The term
‘State’
means any
State,
territory, or possession of the
United States,
the District of Columbia, the Commonwealth of Puerto
Rico
, the Trust Territory of the Pacific Islands, and the Canal Zone.”
Par. (34)(P), (S), (U).
Pub. L. 104–237, § 209(1)
, substituted “Isosafrole” for “Insosafrole” in subpar. (P), “N-Methylephedrine” for “N-Methylepherdrine” in subpar. (S), and “Hydriodic acid” for “Hydriotic acid” in subpar. (U).
Par. (35)(G).
Pub. L. 104–237, § 209(2)
, amended subpar. (G) generally, inserting “(or Methyl Ethyl Ketone)” before period at end.
Par. (35)(I), (J).
Pub. L. 104–237, § 204(a)
, added subpars. (I) and (J).
Par. (39)(A)(iv)(I)(aa).
Pub. L. 104–237, § 401(a)(1)
, (b)(1), substituted “, pseudoephedrine or its salts, optical
isomers,
or salts of optical
isomers,
or phenylpropanolamine or its salts, optical
isomers,
or salts of optical
isomers
unless otherwise provided by regulation of the Attorney General issued pursuant to
section 814(e) of this title
, except that any sale of ordinary over-the-counter pseudoephedrine or phenylpropanolamine products by
retail distributors
shall not be a
regulated transaction
(except as provided in section 401(d) of the
Comprehensive Methamphetamine Control Act of 1996
);” for “as the only active medicinal ingredient or contains ephedrine or its salts, optical
isomers,
or salts of optical
isomers
and therapeutically insignificant quantities of another active medicinal ingredient;”.
Par. (39)(A)(iv)(II).
Pub. L. 104–237, § 401(a)(2)
, (b)(2), inserted “, pseudoephedrine, phenylpropanolamine,” after “ephedrine” and inserted before semicolon “, except that the threshold for any sale of products containing pseudoephedrine or phenylpropanolamine products by
retail distributors
or by
distributors
required to submit reports by
section 830(b)(3) of this title
shall be 24 grams of pseudoephedrine or 24 grams of phenylpropanolamine in a single transaction”.
Pars. (43), (44).
Pub. L. 104–294
, §§ 604(b)(4), 607(j)(2), which provided for amendment to section identical to
Pub. L. 104–237, § 401(b)(3)
, below, were repealed by
Pub. L. 107–273, § 4002(c)(1)
Pub. L. 104–237, § 401(b)(3)
, redesignated par. (43), relating to
felony drug offense,
as (44).
Pars. (45), (46).
Pub. L. 104–237, § 401(b)(4)
, added pars. (45) and (46).
1994—Par. (34)(V), (W).
Pub. L. 103–322, § 330024(b)
, realigned margins and capitalized first letter.
Par. (35).
Pub. L. 103–322, § 330024(d)(1)
, made technical correction to directory language of
Pub. L. 103–200, § 2(a)(4)(B)
. See 1993 Amendment note below.
Par. (39)(A)(iv)(II).
Pub. L. 103–322, § 330024(a)
, substituted “; or” for period at end.
Par. (43).
Pub. L. 103–322, § 90105(d)
, added par. (43) defining
“felony drug offense”
1993—Par. (33).
Pub. L. 103–200, § 2(a)(1)
, substituted “any
list I chemical
or any
list II chemical”
for “any listed precursor chemical or listed essential chemical”.
Par. (34).
Pub. L. 103–200, § 2(a)(2)
, substituted
“list I chemical”
for “listed precursor chemical” and “important to the
manufacture”
for “critical to the creation” in introductory provisions.
Par. (34)(A), (F), (H).
Pub. L. 103–200, § 2(a)(3)
, inserted “, its esters,” before “and”.
Par. (34)(O).
Pub. L. 103–200, § 8(1)
, (2), redesignated subpar. (P) as (O) and struck out former subpar. (O) which read as follows: “D-lysergic acid.”
Par. (34)(P) to (S).
Pub. L. 103–200, § 8(2)
, redesignated subpars. (Q) to (T) as (P) to (S), respectively. Former subpar. (P) redesignated (O).
Par. (34)(T).
Pub. L. 103–200, § 8(2)
, redesignated subpar. (V) as (T). Former subpar. (T) redesignated (S).
Par. (34)(U).
Pub. L. 103–200, § 8(1)
, (2), redesignated subpar. (X) as (U) and struck out former subpar. (U) which read as follows: “N-ethylephedrine.”
Par. (34)(V).
Pub. L. 103–200, § 8(2)
, (4), added subpar. (V) and redesignated former subpar. (V) as (T).
Par. (34)(W).
Pub. L. 103–200, § 8(1)
, (4), added subpar. (W) and struck out former subpar. (W) which read as follows: “N-ethylpseudoephedrine.”
Par. (34)(X).
Pub. L. 103–200, § 8(2)
, (3), redesignated subpar. (Y) as (X) and substituted “through (U)” for “through (X)”.
Par. (34)(Y).
Pub. L. 103–200, § 8(2)
, redesignated subpar. (Y) as (X).
Par. (35).
Pub. L. 103–200, § 2(a)(4)(A)
, (C), substituted
“list II chemical”
for “listed essential chemical” and struck out “as a solvent, reagent, or catalyst” before “in manufacturing”.
Pub. L. 103–200, § 2(a)(4)(B)
, as amended by
Pub. L. 103–322, § 330024(d)(1)
, inserted “(other than a
list I chemical)
” before “specified” the first time appearing.
Par. (37).
Pub. L. 103–200, § 9(a)
, amended par. (37) generally. Prior to amendment, par. (37) read as follows: “The term ‘regular supplier’ means, with respect to a
regulated person,
a supplier with whom the
regulated person
has an established business relationship that is reported to the Attorney General.”
Par. (38).
Pub. L. 103–200, § 2(a)(5)
, inserted before period at end “or who acts as a
broker
or
trader
for an
international transaction
involving a
listed chemical,
a tableting machine, or an encapsulating machine”.
Par. (39)(A).
Pub. L. 103–200
, §§ 2(a)(6)(A), 7, in introductory provisions, substituted “importation, or exportation of, or an
international transaction
involving shipment of,” for “importation or exportation of” and inserted “a
listed chemical,
or if the Attorney General establishes a threshold amount for a specific
listed chemical,
” before “a threshold amount,”.
Par. (39)(A)(iii).
Pub. L. 103–200, § 2(a)(6)(B)
, inserted “or any category of transaction for a specific
listed chemical
or chemicals” after “transaction”.
Par. (39)(A)(iv).
Pub. L. 103–200, § 2(a)(6)(C)
, amended cl. (iv) generally. Prior to amendment, cl. (iv) read as follows: “any transaction in a
listed chemical
that is contained in a
drug
that may be marketed or distributed lawfully in the
United States
under the Federal
Food, Drug, and Cosmetic Act
; or”.
Par. (39)(A)(v).
Pub. L. 103–200, § 2(a)(6)(D)
, inserted before semicolon at end “which the Attorney General has by regulation designated as exempt from the application of this subchapter and subchapter II based on a finding that the mixture is formulated in such a way that it cannot be easily used in the illicit
production
of a
controlled substance
and that the
listed chemical
or chemicals contained in the mixture cannot be readily recovered”.
Par. (40).
Pub. L. 103–200, § 2(a)(7)
, substituted
“list I chemical
or a
list II chemical”
for “listed precursor chemical or a listed essential chemical” in two places.
Pars. (42), (43).
Pub. L. 103–200, § 2(a)(8)
, added pars. (42) and (43).
1990—Par. (32)(A).
Pub. L. 101–647, § 3599I
, substituted “the stimulant” for “the stimulent” in cl. (ii) and “a stimulant” for “a stimulent” in cl. (iii).
Par. (34)(M) to (Y).
Pub. L. 101–647, § 2301(a)
, added subpars. (M) to (Y).
Par. (35)(E).
Pub. L. 101–647, § 2301(b)
, struck out subpar. (E) “Hydriodic acid.”
Par. (41).
Pub. L. 101–647, § 1902(b)
, added par. (41).
1988—Par. (8).
Pub. L. 100–690, § 6054(1)
, inserted “or a
listed chemical”
after “a
controlled substance”
Par. (11).
Pub. L. 100–690, § 6054(2)
, inserted “or a
listed chemical”
after “a
controlled substance”
in two places.
Pars. (33) to (40).
Pub. L. 100–690, § 6054(3)
, added pars. (33) to (40).
1986—Par. (6).
Pub. L. 99–514
substituted “
Internal Revenue Code of 1986
” for “
Internal Revenue Code of 1954
”.
Par. (14).
Pub. L. 99–570, § 1870
, and
Pub. L. 99–646
amended par. (14) identically, substituting “any optical” for “the optical” in second and third sentences.
Par. (25).
Pub. L. 99–570, § 1003(b)(1)
, added par. (25). Former par. (25) redesignated (26).
Pars. (26) to (31).
Pub. L. 99–570, § 1003(b)(2)
, redesignated pars. (25) to (30) as (26) to (31), respectively.
Par. (32).
Pub. L. 99–570, § 1203
, added par. (32).
1984—Pars. (14) to (16).
Pub. L. 98–473, § 507(a)
, added par. (14) and redesignated former pars. (14) to (16) as (15) to (17), respectively.
Par. (17).
Pub. L. 98–473, § 507
, redesignated former par. (16) as (17), and expanded and revised definition of
“narcotic drug”
, including within term
poppy straw,
cocaine, and ecgonine. Former par. (17) redesignated (18).
Pars. (18) to (28).
Pub. L. 98–473, § 507(a)
, redesignated former pars. (17) to (27) as (18) to (28), respectively.
Par. (29).
Pub. L. 98–509
which directed the substitution of “one hundred and eighty” for “twenty-one” in par. (28), was executed to par. (29) in view of the redesignation of par. (28) as par. (29) by
Pub. L. 98–473
Pub. L. 98–473, § 507(a)
, redesignated former par. (28) as (29). Former par. (29) redesignated (30).
Par. (30).
Pub. L. 98–473, § 507(a)
, redesignated former par. (29) as (30).
1979—Par. (4).
Pub. L. 96–132
substituted provisions defining “
Drug Enforcement Administration
” for provisions defining “Bureau of Narcotics and Dangerous
Drugs”
1978—Par. (29).
Pub. L. 95–633
added par. (29).
1974—Pars. (27), (28).
Pub. L. 93–281
added pars. (27) and (28).
Statutory Notes and Related Subsidiaries
Effective Date of 2018 Amendment
Pub. L. 115–391, title IV, § 401(c)
Dec. 21, 2018
132 Stat. 5221
, provided that:
“This section [amending this section and sections
841
and
960
of this title], and the amendments made by this section, shall apply to any offense that was committed before the date of enactment of this Act [
Dec. 21, 2018
], if a sentence for the offense has not been imposed as of such date of enactment.”
Effective Date of 2008 Amendment
Pub. L. 110–425, § 3(j)
Oct. 15, 2008
122 Stat. 4832
, provided that:
“(1)
In general.—
Except as provided in paragraph (2), the amendments made by this Act [enacting
section 831 of this title
and amending this section and sections 823, 827, 829, 841, 843, 882 and 960 of this title] shall take effect 180 days after the date of enactment of this Act [
Oct. 15, 2008
].
“(2)
Definition of practice of telemedicine.—
“(A)
In general.—
Until the earlier of 3 months after the date on which regulations are promulgated to carry out section 311(h) of the
Controlled Substances Act
21 U.S.C. 831(h)
], as amended by this Act, or 15 months after the date of enactment of this Act—
“(i)
the definition of the term ‘
practice of telemedicine
’ in subparagraph (B) of this paragraph shall apply for purposes of the
Controlled Substances Act
21 U.S.C. 801
et seq.]; and
“(ii)
the definition of the term ‘
practice of telemedicine
’ in section 102(54) of the
Controlled Substances Act
21 U.S.C. 802(54)
], as amended by this Act, shall not apply.
“(B)
Temporary phase-in of telemedicine regulation.—
During the period specified in subparagraph (A), 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
Controlled Substances 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.
“(C)
Rule of construction.—
Nothing in this subsection may be construed to create a precedent that any specific course of conduct constitutes the ‘
practice of telemedicine
’ (as that term is defined in section 102(54) of the
Controlled Substances Act
, as amended by this Act) after the end of the period specified in subparagraph (A).”
Effective Date of 2004 Amendment
Pub. L. 108–358, § 2(d)
Oct. 22, 2004
118 Stat. 1664
, provided that:
“The amendments made by this section [amending this section,
section 811 of this title
, and provisions set out as a note under this section] shall take effect 90 days after the date of enactment of this Act [
Oct. 22, 2004
].”
Effective Date of 2002 Amendment
Pub. L. 107–273, div. B, title IV, § 4002(c)(1)
Nov. 2, 2002
116 Stat. 1808
, provided that the amendment made by section 4002(c)(1) is effective
Oct. 11, 1996
Effective Date of 2000 Amendment
Pub. L. 106–310, div. B, title XXXVI, § 3622(b)
Oct. 17, 2000
114 Stat. 1231
, provided that:
“The amendments made by subsection (a) [amending this section] shall take effect 1 year after the date of the enactment of this Act [
Oct. 17, 2000
].”
Effective Date of 1997 Amendment
Amendment by
Pub. L. 105–115
effective 90 days after
Nov. 21, 1997
, except as otherwise provided, see
section 501 of Pub. L. 105–115
, set out as a note under
section 321 of this title
Effective Date of 1996 Amendments
Amendment by
section 604(b)(4) of Pub. L. 104–294
effective
Sept. 13, 1994
, see
section 604(d) of Pub. L. 104–294
, set out as a note under
section 13 of Title 18
, Crimes and Criminal Procedure.
Pub. L. 104–237, title IV, § 401(g)
Oct. 3, 1996
110 Stat. 3110
, provided that:
“Notwithstanding any other provision of this Act [see
section 1(a) of Pub. L. 104–237
, set out as a Short Title of 1996 Amendments note under
section 801 of this title
], this section [amending this section and
section 814 of this title
and enacting provisions set out as a note below] shall not apply to the sale of any pseudoephedrine or phenylpropanolamine product prior to 12 months after the date of enactment of this Act [
Oct. 3, 1996
], except that, on application of a
manufacturer
of a particular pseudoephedrine or phenylpropanolamine
drug
product, the Attorney General may, in her sole discretion, extend such effective date up to an additional six months. Notwithstanding any other provision of law, the decision of the Attorney General on such an application shall not be subject to judicial review.”
Effective Date of 1994 Amendment
Pub. L. 103–322, title XXXIII, § 330024(f)
Sept. 13, 1994
108 Stat. 2151
, provided that:
“The amendments made by this section [amending this section and sections
824
960
, and
971
of this title] shall take effect as of the date that is 120 days after the date of enactment of the
Domestic Chemical Diversion Control Act of 1993
Dec. 17, 1993
].”
Effective Date of 1993 Amendment
Pub. L. 103–200, § 11
Dec. 17, 1993
107 Stat. 2341
, provided that:
“This Act [enacting
section 814 of this title
, amending this section and sections 821 to 824, 830, 843, 880, 957, 958, 960, and 971 of this title, and enacting provisions set out as a note under
section 801 of this title
] and the amendments made by this Act shall take effect on the date that is 120 days after the date of enactment of this Act [
Dec. 17, 1993
].”
Effective Date of 1990 Amendment
Pub. L. 101–647, title XIX, § 1902(d)
Nov. 29, 1990
104 Stat. 4852
, provided that:
“This section [amending this section and
section 812 of this title
and enacting provisions set out as a note under
section 829 of this title
] and the amendment made by this section shall take effect 90 days after the date of enactment of this Act [
Nov. 29, 1990
].”
Effective Date of 1988 Amendment
Pub. L. 100–690, title VI, § 6061
Nov. 18, 1988
102 Stat. 4320
, provided that:
“Except as otherwise provided in this subtitle, this subtitle [subtitle A (§§ 6051–6061) of title VI of
Pub. L. 100–690
, enacting
section 971 of this title
, amending this section and sections 830, 841 to 843, 872, 876, 881, 960, and 961 of this title, and enacting provisions set out as notes under this section and
section 971 of this title
] shall take effect 120 days after the enactment of this Act [
Nov. 18, 1988
].”
Effective Date of 1978 Amendment
Amendment by
Pub. L. 95–633
effective on date the
Convention on Psychotropic Substances
enters into force in the
United States
July 15, 1980
], see
section 112 of Pub. L. 95–633
, set out as an Effective Date note under
section 801a of this title
Regulations
Pub. L. 110–425, § 3(k)(1)
Oct. 15, 2008
122 Stat. 4833
, provided that:
“The Attorney General may promulgate and enforce any rules, regulations, and procedures which may be necessary and appropriate for the efficient execution of functions under this Act [see Short Title of 2008 Amendment note set out under
section 801 of this title
] or the amendments made by this Act, and, with the concurrence of the
Secretary
of Health and Human Services where this Act or the amendments made by this Act so provide, promulgate any interim rules necessary for the implementation of this Act or the amendments made by this Act, prior to its effective date [see Effective Date of 2008 Amendment note above].”
Pub. L. 98–509, title III, § 301(b)
Oct. 19, 1984
98 Stat. 2364
, provided that:
“The
Secretary
of Health and Human Services shall, within ninety days of the date of the enactment of this Act [
Oct. 19, 1984
], promulgate regulations for the administration of section 102(28) of the
Controlled Substances Act
21 U.S.C. 802(29)
] as amended by subsection (a) and shall include in the first report submitted under section 505(b) [503(b)] of the
Public Health Service Act
[former
42 U.S.C. 290aa–2(b)
] after the expiration of such ninety days the findings of the
Secretary
with respect to the effect of the amendment made by subsection (a).”
Construction of 2008 Amendment
Pub. L. 110–425, § 4
Oct. 15, 2008
122 Stat. 4834
, provided that:
“Nothing in this Act [see Short Title of 2008 Amendment note set out under
section 801 of this title
] or the amendments made by this Act shall be construed as authorizing, prohibiting, or limiting the use of electronic prescriptions for
controlled substances.
Preservation of State Authority To Regulate Scheduled Listed Chemicals
Pub. L. 109–177, title VII, § 711(g)
Mar. 9, 2006
120 Stat. 263
, provided that:
“This section [amending this section and sections
830
841
842
, and
844
of this title and enacting provisions set out as notes under sections
830
and
844
of this title] and the amendments made by this section may not be construed as having any legal effect on section 708 of the
Controlled Substances Act
21 U.S.C. 903
] as applied to the regulation of scheduled
listed chemicals
(as defined in section 102(45) of such Act [
21 U.S.C. 802(45)
]).”
Report on Diversion of Ordinary, Over-the-Counter Pseudoephedrine and Phenylpropanolamine Products
Pub. L. 106–310, div. B, title XXXVI, § 3642
Oct. 17, 2000
114 Stat. 1237
, provided that:
“(a)
Study.—
The Attorney General shall conduct a study of the use of ordinary, over-the-counter pseudoephedrine and phenylpropanolamine products in the clandestine
production
of illicit
drugs.
Sources of data for the study shall include the following:
“(1)
Information from Federal,
State
, and local clandestine laboratory seizures and related investigations identifying the source, type, or brand of
drug
products being utilized and how they were obtained for the illicit
production
of methamphetamine and amphetamine.
“(2)
Information submitted voluntarily from the pharmaceutical and retail industries involved in the
manufacture
, distribution, and sale of
drug
products containing ephedrine, pseudoephedrine, and phenylpropanolamine, including information on changes in the pattern, volume, or both, of sales of ordinary, over-the-counter pseudoephedrine and phenylpropanolamine products.
“(b)
Report.—
“(1)
Requirement.—
Not later than 1 year after the date of the enactment of this Act [
Oct. 17, 2000
], the Attorney General shall submit to
Congress
a report on the study conducted under subsection (a).
“(2)
Elements.—
The report shall include—
“(A)
the findings of the Attorney General as a result of the study; and
“(B)
such recommendations on the need to establish additional measures to prevent diversion of ordinary, over-the-counter pseudoephedrine and phenylpropanolamine (such as a threshold on ordinary, over-the-counter pseudoephedrine and phenylpropanolamine products) as the Attorney General considers appropriate.
“(3)
Matters considered.—
In preparing the report, the Attorney General shall consider the comments and recommendations including the comments on the Attorney General’s proposed findings and recommendations, of
State
and local law enforcement and regulatory officials and of representatives of the industry described in subsection (a)(2).
“(c)
Regulation of Retail Sales.—
“(1)
In general.—
Notwithstanding section 401(d) of the
Comprehensive Methamphetamine Control Act of 1996
Pub. L. 104–237
] (
21 U.S.C. 802
note) and subject to paragraph (2), the Attorney General shall establish by regulation a single-transaction limit of not less than 24 grams of ordinary, over-the-counter pseudoephedrine or phenylpropanolamine (as the case may be) for
retail distributors,
if the Attorney General finds, in the report under subsection (b), that—
“(A)
there is a significant number of instances (as set forth in paragraph (3)(A) of such
section 401(d)
for purposes of such section) where ordinary, over-the-counter pseudoephedrine products, phenylpropanolamine products, or both such products that were purchased from
retail distributors
were widely used in the clandestine
production
of illicit
drugs;
and
“(B)
the best practical method of preventing such use is the establishment of single-transaction limits for
retail distributors
of either or both of such products.
“(2)
Due process.—
The Attorney General shall establish the single-transaction limit under paragraph (1) only after notice, comment, and an informal hearing.”
Regulation of Retail Sales of Certain Precursor Chemicals; Effect on Thresholds; Combination Ephedrine Products
Pub. L. 104–237, title IV, § 401(d)
–(f),
Oct. 3, 1996
110 Stat. 3108
, which authorized the Attorney General to establish a single-transaction limit of 24 grams for pseudoephedrine, phenylpropanolamine, and combination ephedrine products for
retail distributors,
was repealed by
Pub. L. 109–177, title VII, § 712(b)
Mar. 9, 2006
120 Stat. 264
Exemption for Substances in Paragraph (41)
Pub. L. 101–647, title XIX, § 1903
Nov. 29, 1990
104 Stat. 4853
, as amended by
Pub. L. 108–358, § 2(c)
Oct. 22, 2004
118 Stat. 1663
, provided that:
“(a)
Drugs for Treatment of Rare Diseases.—
If the Attorney General finds that a
drug
listed in paragraph (41) of section 102 of the
Controlled Substances Act
(as added by section 2 [1902] of this Act) is—
“(1)
approved by the
Food and Drug Administration
as an accepted treatment for a rare disease or condition, as defined in section 526 of the Federal
Food, Drug, and Cosmetic Act
21 U.S.C. 360bb
); and
“(2)
does not have a significant potential for abuse, the Attorney General may exempt such
drug
from any
production
regulations otherwise issued under the
Controlled Substances Act
as may be necessary to ensure adequate supplies of such
drug
for medical purposes.
“(b)
Date of Issuance of Regulations.—
The Attorney General shall issue regulations implementing this section not later than 45 days after the date of enactment of this Act [
Nov. 29, 1990
], except that the regulations required under section 3(a) [former 1903(a)] shall be issued not later than 180 days after the date of enactment of this Act.”
CFR Title
Parts
21
1300
1309
1310
1313
1314
1315
32
552
39
232
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