-CITE-
21 USC Sec. 802 01/22/02
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 13 - DRUG ABUSE
PREVENTION AND CONTROL
SUBCHAPTER I - CONTROL
AND ENFORCEMENT
Part A - Introductory
Provisions
-HEAD-
Sec. 802. Definitions
-STATUTE-
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
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(A) 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) a drug which contains
any quantity of barbituric acid or any
of the salts of barbituric acid; or
(B) a 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 a 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
a 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 a
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
a drug or other substance.
(16) The
term ''marihuana'' means 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. Such term
does not include 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'' 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
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(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
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(i) a 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, Sec. 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, 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) 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 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 of this chapter;
(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.) unless -
(I)(aa) the drug contains
ephedrine or its salts, optical isomers, or salts of optical isomers,
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);
or
(bb) 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
ephedrine, pseudoephedrine, phenylpropanolamine, or other 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, 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 9 grams
of pseudoephedrine or 9 grams of phenylpropanolamine in a single
transaction and sold in package sizes of not more than 3 grams
of pseudoephedrine base or 3 grams of phenylpropanolamine base;
or (v) 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 of this chapter 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, and corticosteroids) that promotes
muscle growth, and includes -
(i) boldenone,
(ii) chlorotestosterone,
(iii) clostebol,
(iv) dehydrochlormethyltestosterone,
(v) dihydrotestosterone,
(vi) drostanolone,
(vii) ethylestrenol,
(viii) fluoxymesterone,
(ix) formebulone,
(x) mesterolone,
(xi) methandienone,
(xii) methandranone,
(xiii) methandriol,
(xiv) methandrostenolone,
(xv) methenolone,
(xvi) methyltestosterone,
(xvii) mibolerone,
(xviii) nandrolone,
(xix) norethandrolone,
(xx) oxandrolone,
(xxi) oxymesterone,
(xxii) oxymetholone,
(xxiii) stanolone,
(xxiv) stanozolol,
(xxv) testolactone,
(xxvi) testosterone,
(xxvii) trenbolone, and
(xxviii) any salt, ester,
or isomer of a drug or substance described
or listed in this paragraph, if that salt, ester, or isomer
promotes muscle growth.
(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).
(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, or depressant
or stimulant substances.
(45) The
term ''ordinary over-the-counter pseudoephedrine or phenylpropanolamine
product'' means any product containing pseudoephedrine or phenylpropanolamine
that is -
(A) regulated pursuant to
this subchapter; and
(B)(i) except for liquids,
sold in package sizes of not more than
3.0 grams of pseudoephedrine base or 3.0 grams of phenylpropanolamine
base, and that is packaged in blister packs, each
blister containing not more than two dosage units, or where the
use of blister packs is technically infeasible, that is packaged
in unit dose packets or pouches; and (ii)
for liquids, sold in package sizes of not more than 3.0 grams
of pseudoephedrine base or 3.0 grams of phenylpropanolamine base.
(46)(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 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, sale for personal use means the
sale of below-threshold quantities in a single transaction to an
individual for legitimate medical use.
(C) 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) A drug store is
an entity within SIC code 5912.
-SOURCE-
(Pub. L. 91-513, title II,
Sec. 102, Oct. 27, 1970, 84 Stat. 1242; Pub.
L. 93-281, Sec. 2, May 14, 1974, 88 Stat. 124; Pub. L. 95-633, title
I, Sec. 102(b), Nov. 10, 1978, 92 Stat. 3772; Pub. L. 96-88, title
V, Sec. 509(b), Oct. 17, 1979, 93 Stat. 695; Pub. L. 96-132, Sec.
16(a), Nov. 30, 1979, 93 Stat. 1049; Pub. L. 98-473, title II, Sec.
507(a), (b), Oct. 12, 1984, 98 Stat. 2071; Pub. L. 98-509, title
III, Sec. 301(a), Oct. 19, 1984, 98 Stat. 2364; Pub. L. 99-514,
Sec. 2, Oct. 22, 1986, 100 Stat. 2095; Pub. L. 99-570, title
I, Sec. 1003(b), 1203, 1870, Oct. 27, 1986, 100 Stat. 3207-6, 3207-13,
3207-56; Pub. L. 99-646, Sec. 83, Nov. 10, 1986, 100 Stat. 3619;
Pub. L. 100-690, title VI, Sec. 6054, Nov. 18, 1988, 102 Stat.
4316; Pub. L. 101-647, title XIX, Sec. 1902(b), title XXIII, Sec.
2301, title XXXV, Sec. 3599I, Nov. 29, 1990, 104 Stat. 4852, 4858,
4932; Pub. L. 103-200, Sec. 2(a), 7-9(a), Dec. 17, 1993, 107 Stat.
2333, 2340; Pub. L. 103-322, title IX, Sec. 90105(d), title XXXIII,
Sec. 330024(a), (b), (d)(1), Sept. 13, 1994, 108 Stat. 1988,
2150; Pub. L. 104-237, title II, Sec. 204(a), 209, title IV, Sec.
401(a), (b), Oct. 3, 1996, 110 Stat. 3102, 3104, 3106, 3107; Pub.
L. 104-294, title VI, Sec. 604(b)(4), 607(j), Oct. 11, 1996, 110
Stat. 3506, 3512; Pub. L. 105-115, title I, Sec. 126(c)(3), Nov.
21, 1997, 111 Stat. 2328; Pub. L. 106-172, Sec. 3(c), 5(a), Feb.
18, 2000, 114 Stat. 9, 10; Pub. L. 106-310, div. B, title XXXVI,
Sec. 3622(a), Oct. 17, 2000, 114 Stat. 1231.)
-REFTEXT-
REFERENCES
IN TEXT
This subchapter, referred
to in introductory provisions and in par. (39)(A)(iii), (v), was in
the original ''this title'', meaning title II of Pub. L. 91-513, Oct.
27, 1970, 84 Stat. 1242, as amended, 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. Schedules I, II, III, IV, and V, referred
to in pars. (6), (14), and (32)(A), are set out in section 812(c)
of this title. Subchapter II of this chapter, referred to in par. (39)(A)(iii),
(v), 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 par. (39)(A)(iv),
is act June 25, 1938, ch. 675, 52 Stat. 1040, as amended,
which is classified generally to chapter 9 (Sec. 301 et seq.)
of this title. For complete classification of this Act to the
Code, see section 301 of this title and Tables.
Section 401(d) of the Comprehensive
Methamphetamine Control Act of
1996, referred to in par. (39)(A)(iv)(I)(aa), is section 401(d) of
Pub. L. 104-237, which is set out below.
-MISC2-
AMENDMENTS
2000 - Par. (32)(A).
Pub. L. 106-172, Sec. 5(a)(1),
substituted ''subparagraph (C)'' for ''subparagraph (B)'' in introductory
provisions.
Par. (32)(B), (C).
Pub. L. 106-172, Sec. 5(a)(2),
(3), added subpar. (B)
and redesignated former subpar.
(B) as (C). Par.
(34)(X), (Y).
Pub. L. 106-172, Sec. 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, Sec. 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, Sec. 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,
Sec. 209(2), amended subpar. (G) generally,
inserting ''(or Methyl Ethyl Ketone)'' before period at end.
Par. (35)(I), (J). Pub. L.
104-237, Sec. 204(a), added subpars. (I) and (J).
Par. (39)(A)(iv)(I)(aa). Pub.
L. 104-237, Sec. 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, Sec. 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.
104-237, Sec. 401(b)(3), and Pub. L. 104-294,
Sec. 604(b)(4), 607(j)(2), amended section identically, redesignating
par. (43), relating to felony drug offense, as (44).
Pars. (45), (46). Pub. L.
104-237, Sec. 401(b)(4), added pars.(45) and (46). 1994 - Par. (34)(V),
(W). Pub. L. 103-322, Sec. 330024(b), realigned
margins and capitalized first letter.
Par. (35). Pub. L. 103-322,
Sec. 330024(d)(1), made technical correction
to directory language of Pub. L. 103-200, Sec. 2(a)(4)(B).
See 1993 Amendment note below.
Par. (39)(A)(iv)(II). Pub.
L. 103-322, Sec. 330024(a), substituted ''; or'' for period at end.
Par. (43). Pub. L. 103-322,
Sec. 90105(d), added par. (43) defining
''felony drug offense''. 1993
- Par. (33). Pub. L. 103-200, Sec. 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,
Sec. 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, Sec. 2(a)(3), inserted '',
its esters,'' before ''and''.
Par. (34)(O). Pub. L. 103-200,
Sec. 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, Sec. 8(2), redesignated subpars. (Q) to (T) as (P) to (S),
respectively. Former subpar. (P) redesignated (O).
Par. (34)(T). Pub. L. 103-200,
Sec. 8(2), redesignated subpar. (V) as (T). Former subpar. (T) redesignated
(S).
Par. (34)(U). Pub. L. 103-200,
Sec. 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,
Sec. 8(2), (4), added subpar. (V) and
redesignated former subpar. (V) as (T).
Par. (34)(W). Pub. L. 103-200,
Sec. 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,
Sec. 8(2), (3), redesignated subpar. (Y) as (X) and substituted ''through
(U)'' for ''through (X)''.
Par. (34)(Y). Pub. L. 103-200,
Sec. 8(2), redesignated subpar. (Y) as (X).
Par. (35). Pub. L. 103-200,
Sec. 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, Sec. 2(a)(4)(B),
as amended by Pub. L. 103-322, Sec.
330024(d)(1), inserted ''(other than a list I chemical)'' before
''specified'' the first time appearing.
Par. (37). Pub. L. 103-200,
Sec. 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,
Sec. 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,
Sec. 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, Sec. 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, Sec. 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 nited States under the Federal Food, Drug, and Cosmetic Act;
or''.
Par. (39)(A)(v). Pub. L. 103-200,
Sec. 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 of this chapter 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,
Sec. 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, Sec. 2(a)(8), added pars. (42) and (43). 1990 - Par. (32)(A).
Pub. L. 101-647, Sec. 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, Sec. 2301(a), added subpars.
(M) to (Y).
Par. (35)(E). Pub. L. 101-647,
Sec. 2301(b), struck out subpar. (E)
''Hydriodic acid.''
Par. (41). Pub. L. 101-647,
Sec. 1902(b), added par. (41). 1988 - Par. (8). Pub. L. 100-690, Sec.
6054(1), inserted ''or a listed
chemical'' after ''a controlled substance''.
Par. (11). Pub. L. 100-690,
Sec. 6054(2), inserted ''or a listed chemical'' after ''a controlled
substance'' in two places.
Pars. (33) to (40). Pub. L.
100-690, Sec. 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,
Sec. 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,
Sec. 1003(b)(1), added par. (25). Former par. (25) redesignated (26).
Pars. (26) to (31). Pub. L.
99-570, Sec. 1003(b)(2), redesignated pars.
(25) to (30) as (26) to (31), respectively.
Par. (32). Pub. L. 99-570,
Sec. 1203, added par. (32). 1984 - Pars. (14) to (16). Pub. L. 98-473,
Sec. 507(a), added par.
(14) and redesignated former pars. (14) to (16) as (15) to (17),
respectively.
Par. (17). Pub. L. 98-473,
Sec. 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, Sec. 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, Sec. 507(a),
redesignated former par. (28) as (29). Former par. (29) redesignated
(30).
Par. (30). Pub. L. 98-473,
Sec. 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).
-CHANGE-
CHANGE OF
NAME
''Secretary of Health and
Human Services'' substituted for ''Secretary
of Health, Education, and Welfare'' in par. (24) pursuant
to section 509(b) of Pub. L. 96-88, which is classified to section
3508(b) of Title 20, Education.
-MISC4-
EFFECTIVE
DATE OF 2000 AMENDMENT
Pub. L. 106-310, div. B,
title XXXVI, Sec. 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. Section
401(g) of Pub. L. 104-237 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 ther 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
Section 330024(f) of Pub.
L. 103-322 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
Section 11 of
Pub. L. 103-200 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
Section 1902(d)
of Pub. L. 101-647 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
Section 6061 of title VI
of Pub. L. 100-690 provided that: ''Except
as otherwise provided in this subtitle, this subtitle (subtitle
A (Sec. 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
Section 301(b) of Pub. L.
98-509 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).''
REPORT ON
DIVERSION OF ORDINARY, OVER-THE-COUNTER PSEUDOEPHEDRINE AND
PHENYLPROPANOLAMINE PRODUCTS
Pub. L. 106-310, div. B,
title XXXVI, Sec. 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
Section 401(d)-(f) of Pub.
L. 104-237 provided that:
''(d) Regulation of Retail
Sales. -
''(1) Pseudoephedrine. -
''(A) Limit. -
''(i) In general. -
Not sooner than the effective date of this
section (see Effective Date of 1996 Amendments note above)
and subject to the requirements of clause (ii), the Attorney
General may establish by regulation a single-transaction
limit of 24 grams of pseudoephedrine base for
retail distributors. Notwithstanding any other provision
of law, the single-transaction
threshold quantity for pseudoephedrine-containing
compounds may not be lowered beyond
that established in this paragraph.
''(ii) Conditions. -
In order to establish a single-transaction
limit of 24 grams of pseudoephedrine base, the
Attorney General shall establish, following notice, comment,
and an informal hearing that since the date of enactment
of this Act (Oct. 3, 1996) there are a significant number
of instances where ordinary over-the-counter pseudoephedrine
products as established in paragraph (45) of section
102 of the Controlled Substances Act (21 U.S.C. 802(45)),
as added by this Act, sold by retail distributors as
established in paragraph (46) in section 102 of the Controlled
Substances Act (21 U.S.C. 802(46)), are being widely
used as a significant source of precursor chemicals for
illegal manufacture of a controlled substance for distribution
or sale.
''(B) Violation. - Any
individual or business that violates the
thresholds established in this paragraph shall, with respect
to the first such violation, receive a warning letter from
the Attorney General and, if a business, the business shall
be required to conduct mandatory education of the sales employees
of the firm with regard to the legal sales of pseudoephedrine.
For a second violation occurring within 2 years
of the first violation, the business or individual shall
be subject to a civil penalty
of not more than $5,000. For any subsequent
violation occurring within 2 years of the previous violation,
the business or individual shall be subject to a civil
penalty not to exceed the amount of the previous civil penalty
plus $5,000.
''(2) Phenylpropanolamine.
-
''(A) Limit. -
''(i) In general. -
Not sooner than the effective date of this
section and subject to the requirements of clause (ii),
the Attorney General
may establish by regulation a single-transaction
limit of 24 grams of phenylpropanolamine base
for retail distributors. Notwithstanding any other provision
of law, the single-transaction threshold quantity for
phenylpropanolamine-containing compounds may not be lowered
beyond that established in this paragraph.
''(ii) Conditions. -
In order to establish a single-transaction
limit of 24 grams of phenylpropanolamine base,
the Attorney General shall establish, following notice,
comment, and an informal
hearing, that since the date of enactment
of this Act there are a significant number of instances
where ordinary over-the-counter phenylpropanolamine products
as established in paragraph (45) of section 102 of the
Controlled Substances Act (21 U.S.C. 802(45)), as added
by this Act, sold by
retail distributors as established in paragraph
(46) in section 102 of the Controlled Substances Act
(21 U.S.C. 802(46)), are being used as a significant source
of precursor chemicals for illegal manufacture of a controlled
substance in bulk.
''(B) Violation. - Any
individual or business that violates the
thresholds established in this paragraph shall, with respect
to the first such violation, receive a warning letter from
the Attorney General and, if a business, the business shall
be required to conduct mandatory education of the sales employees
of the firm with regard to the legal sales of pseudoephedrine.
For a second violation occurring within 2 years
of the first violation, the business or individual shall
be subject to a civil penalty
of not more than $5,000. For any subsequent
violation occurring within 2 years of the previous violation,
the business or individual shall be subject to a civil
penalty not to exceed the amount of the previous civil penalty
plus $5,000.
''(3) Significant number
of instances. -
''(A) In general. - For
purposes of this subsection, isolated or
infrequent use, or use in insubstantial quantities, of ordinary
over-the-counter pseudoephedrine or phenylpropanolamine,
as defined in section 102(45) of the Controlled
Substances Act, as added by section 401(b) of this Act,
and sold at the retail level for the illicit manufacture
of methamphetamine or amphetamine
may not be used by the Attorney
General as the basis for establishing the conditions under
paragraph (1)(A)(ii) of this subsection, with respect to
pseudoephedrine, and paragraph
(2)(A)(ii) of this subsection, with
respect to phenylpropanolamine.
''(B) Considerations and
report. - The Attorney General shall -
''(i) in establishing
a finding under paragraph (1)(A)(ii) or
(2)(A)(ii) of this subsection, consult with the Secretary
of Health and Human Services
in order to consider the effects on
public health that would occur from the establishment of
new single transaction
limits as provided in such paragraph; and
''(ii) upon establishing
a finding, transmit a report to the
Committees on the Judiciary in both, respectively, the
House of Representatives
and the Senate in which the Attorney General
will provide the factual basis for establishing the new
single transaction limits.
''(4) Definition of business.
- For purposes of this subsection,
the term 'business' means the entity that makes the direct
sale and does not include the parent company of a business
not involved in a direct
sale regulated by this subsection.
''(5) Judicial review. -
Any regulation promulgated by the Attorney
General under this section shall be subject to judicial review
pursuant to section 507 of the Controlled Substances Act (21
U.S.C. 877).
''(e) Effect on Thresholds.
- Nothing in the amendments made by subsection
(b) (amending this section) or the provisions of subsection
(d) shall affect the authority of the Attorney General to
modify thresholds (including cumulative thresholds) for retail
distributors for products other
than ordinary over-the-counter pseudoephedrine
or phenylpropanolamine products (as defined in section
102(45) of the Controlled Substances Act (21 U.S.C. 802(45)),
as added by this section) or for non-retail distributors, importers,
or exporters.
''(f) Combination Ephedrine
Products. -
''(1) In general. - For
the purposes of this section, combination
ephedrine products shall be treated the same as pseudoephedrine
products, except that -
''(A) a single transaction
limit of 24 grams shall be effective
as of the date of enactment of this Act (Oct. 3, 1996)
and shall apply to sales of all combination ephedrine products,
notwithstanding the form in which those products are packaged,
made by retail distributors or distributors required to
submit a report under section 310(b)(3) of the Controlled
Substances Act (21 U.S.C.
830(b)(3)) (as added by section 402 of
this Act);
''(B) for regulated transactions
for combination ephedrine products
other than sales described in subparagraph (A), the transaction
limit shall be -
''(i) 1 kilogram of
ephedrine base, effective on the date of
enactment of this Act; or ''(ii)
a threshold other than the threshold described in clause
(i), if established by the Attorney General not earlier
than 1 year after the date of enactment of this Act; and
''(C) the penalties provided
in subsection (d)(1)(B) of this section
shall take effect on the date of enactment of this Act for
any individual or business that violates the single transaction
limit of 24 grams for combination ephedrine products.
''(2) Definition. - For
the purposes of this section, the term '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.''
EXEMPTION
FOR SUBSTANCES IN PARAGRAPH (41)
Section 1903 of Pub. L. 101-647
provided that:
''(a) Abuse Potential. -
The Attorney General, upon the recommendation
of the Secretary of Health and Human Services, may, by
regulation, exempt any compound, mixture, or preparation containing
a substance in paragraph (41) of section 102 of the Controlled
Substances Act (21 U.S.C. 802(41)) (as added by section 2
(1902) of this Act) from the application of all or any part of
the Controlled Substances
Act (21 U.S.C. 801 et seq.) if, because
of its concentration, preparation,
mixture or delivery system, it has
no significant potential for abuse.
''(b) 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.
''(c) 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) (1903(a))
shall be issued not later
than 180 days after the date of enactment of
this Act.''
-SECREF-
SECTION REFERRED
TO IN OTHER SECTIONS
This section is referred
to in sections 814, 822,
823, 830, 862a,
889,
951, 956, 957,
958, 967, 1115, 1701, 1907
of this title; title 7
sections 2015, 2021; title 8 sections 1101, 1182, 1227; title 10
section 986; title 16 section
559b; title 18 sections 175b, 342, 521,
842, 922, 924, 1791, 1952, 1961, 2118, 3142, 3563, 3592; title
19 sections 1401, 1584, 1607;
title 20 section 1091; title 22 sections
2291, 2708, 2714; title 23 section 410; title 25 section 4103;
title 29 sections 1111, 1854, 2892; title 42 sections 201, 1437a,
1437d, 1437f, 1786, 2000e-2, 2473c, 3411, 3602, 3607, 5667, 5667a,
9601, 9919, 11851, 11905, 11924, 12602; title 46 section 2101;
title 46 App. section 1903; title 48 sections 1902, 1903; title
49 sections 5331, 20140, 30301, 31102, 31301, 31306, 44106, 44111,
44703, 44710, 44713, 45101, 46306, 80302; title 50 section 404i.
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