|
Regulations
& Codified CSA > USC > Subchapter
I, Part A > Section 802
Section 802. Definitions
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) 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 (i) barbituric acid or any of the salts of
barbituric acid; or (ii) any derivative of barbituric acid which has been designated
by the Secretary as habit forming under section 352(d) of this title; 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 --
(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 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.
(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 (B), 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) Such term does not include --
(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 505 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 355) [21 U.S.C.A. Section 355] 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) Proprionic 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, Section 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) 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 310;
(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 containedin 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 310(b)(3) of this title shall be
9 grams of pseudoephedrine or 9 grams of pheylpropanolamine in a single
transaction and sold in package sizes of not more than 3 grams of
pseudoephedrine base or 3 grams of phenylpropanolamine base;
(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, marijuana 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 title; 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.
(Pub.L. 91-513, Title II, Section 102, Oct. 27, 1970, 84 Stat. 1242; Pub.L. 93-281, Section 2,
May 14, 1974, 88 Stat. 124; Pub.L. 95-633, Title I,Section 102(b), Nov. 10, 1978, 92 Stat.
3772; Pub.L. 96-88, Title V, Section 509, Oct. 17, 1979, 93 Stat. 695; Pub.L. 96-132, Section
16(a), Nov. 30, 1979, 93 Stat. 1049; Pub.L. 98-473, Title II, Section 507(a), (b), Oct. 12, 1984,
98 Stat. 2071; Pub.L. 98-509, Title III, Section 301(a), Oct. 19, 1984, 98 Stat. 2364; Pub.L.
99-570, Title I, Sections 1003(b), 1203, 1870, Oct. 27, 1986, 100 Stat. 3207-6, 3207-13,
3207-56; Pub.L. 99-646, Section 83, Nov. 10, 1986, 100 Stat. 3619; Pub.L. 100-690, Title VI,
Section 6054, Nov. 18, 1988, 102 Stat. 4316; Pub.L. 101-647, Title XIX, Section 1902(b), Title
XXIII, Section 2301, Title XXXV, Section 3599I, Nov. 29, 1990, 104 Stat. 4852, 4858,
4932; Pub. L. 103-200, Secs. 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, Secs. 204(a), 209, title IV, Sec. 401(a), (b), Oct. 3,
1996, 110 Stat. 3102, 3104, 3106, 3107; Pub. L. 104-294, title VI, Secs.
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, Secs. 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.)
EDITORIAL NOTES
References in Text. "This subchapter", referred to in text, was in the original "this title" which is
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 Short Title note set out
under section 801 of this title and Tables volume.
"Subchapter II of this chapter", referred to in text, 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
volume.
The Federal Food, Drug, and Cosmetic Act, referred to in par. (39), is Act June 25, 1938, c. 675,
52 Stat. 1040, as amended, which is classified generally to chapter 9 (Section 301 et seq.) of this
title. For complete classification of this Act to the Code, see section 301 of this title and Tables
volume.
Subtitle E of the Internal Revenue Code of 1986, referred to in par. (6), is classified to section
5001 et seq. of Title 26, U.S.C.A., Internal Revenue Code.
Schedule I or II, referred to in par. (32)(A), are set out in section 812(c) of this title.
Codifications.
Amendment by section 83 of Pub.L. 99-646 to par. (14) was not executed in view
of prior amendment to such par. by Pub.L. 99-570 making identical amendment.
Internal Revenue Code of 1954 in any law, etc., to include reference to Internal Revenue Code of
1986, except when inappropriate, see Pub.L. 99-514, Section 2, Oct. 22, 1986, 100 Stat. 1095.
Amendment by section 301(a) of Pub.L. 98-509, Oct. 19, 1984, 98 Stat. 2364, to par. (28) which
substituted "one hundred and eighty" for "twenty-one" was executed to par. (29), which had been
par. (28) prior to its redesignation by Pub.L. 98-473, Title II, Section 507(a), Oct. 12, 1984, 98
Stat. 2071, as the probable intent of Congress.
Effective Date of 1996 Amendments. Amendment by Section 604 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, this section shall not apply to the sale of any pseudoephedrine or phenylpropanolamine
product prior to 12 months after the date of enactment of this Act, 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 1993 Amendments. Section 11 of Pub.L. 103-200 provided that: "This Act
and the amendments made by this Act [enacting section 814 of this title, amending this section
and sections 821, 822, 823, 824, 830, 843, 880, 957, 958, 960, and 971 of this title and enacting
provisions set out as notes under this section and section 801 of this title] 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 and the amendment made by this section [enacting par. (41) of this section, amending
section 812 of this title, and enacting a provision set out as a note under section 829 of this title]
shall take effect 90 days after the date of enactment of this Act [Nov. 29, 1990]."
Effective Date of 1988 Amendment. Section 6061 of Pub.L. 100-690 provided that: "Except as
otherwise provided in this subtitle, this subtitle [enacting section 972 of this title, amending
sections 802, 830, 841, 842, 843, 872, 876, 881, 960 and 961 of this title] shall take effect 120
days after the enactment of this Act [Nov. 18, 1988]."
Change of Name.
"Secretary of Health and Human Services" was substituted for "Secretary of
Health, Education, and Welfare" on authority of Pub.L. 96-88, Title V, Section 509, Oct. 17,
1979, 93 Stat. 695, which is classified to section 3508 of Title 20, U.S.C.A., Education.
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) to (f) of Pub.L. 104-237
(d) Regulation of Retail Sales.--
(1) Pseudoephedrine.--
(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 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 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) 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, 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 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 (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.
Regulations by Attorney General.
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 [par. (41) of this section] (as added by
section 2 of this Act [sic] ) from the application of all or any part of the Controlled
Substances Act [21 U.S.C.A. Section 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 of this Act [sic] ) 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) [21 U.S.C.A. Section 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 [21
U.S.C.A. Section 801 et seq.] 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) [sic]
shall be issued not later than 180 days after the date of enactment of this Act [Nov.
29, 1990]."
Promulgation of Regulations for Administration of Amendment by Alcohol Abuse, Drug Abuse,
and Mental Health Amendments of 1984; Inclusion of Findings in Report.
Section 301(b) of
Pub.L. 98-509, 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 as amended by subsection (a) [probably par. 29 of this section] and shall include in the first
report submitted under section 505(b) of the Public Health Service Act [section 290aa-4 of Title
42, The Public Health and Welfare] after the expiration of such ninety days the findings of the
Secretary with respect to the effect of the amendment made by subsection (a) [amending par. (29)
of this section]."
Code of Federal Regulations
Controlled drugs, warnings, see 21 CFR 290.5 et seq.
Treatment of narcotic addicts, see 21 CFR 291.501 et seq. Back
to Top
NOTICE: This is an
unofficial version. An official version of this publication may be obtained
directly from the Government Printing Office (GPO).
Registration
Support
Toll Free Number: 1-800-882-9539
ARCOS
| Career Opportunities | Chemical Program |
Controlled
Substance Schedules | Drugs and
Chemicals of Concern
Electronic Commerce Initiatives | | Federal Register
Notices | Import Export | Links
| Meetings
and Events | NFLIS
Offices &
Directories | On-Line Forms & Applications |
Program
Description | Publications
|
Questions & Answers | Quotas
Reports Required by 21 CFR | Title 21 Regulations & Codified
CSA
Contact Us | Home
| Hot
Items | Site Map | Search | What's New
|
