21 U.S. Code § 802 - Definitions

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—

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.

The term “ Drug Enforcement Administration ” means the Drug Enforcement Administration in the Department of Justice .

The term “control” means to add aimmediate precursor, to a schedule under part B of this subchapter, whether by transfer from another schedule or otherwise.

The term “controlled substance” means a 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.

The term “counterfeit substance” means 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.

The terms “deliver” or “delivery” mean the actual, constructive, or attempted transfer of a controlled substance or a (9) The term “depressant or stimulant substance” means—

a 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

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 delivers a controlled substance to an ultimate user or research subject.

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.

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.

The term “ production, preparation, propagation, compounding, or processing of apractitioner as an incident to his administration or dispensing of suchmanufacturer” means a person who manufactures a (16)

Subject to subparagraph (B), the terms “marihuana” and “marijuana” mean all parts of the plant Cannabis sativa L., whether growing or not; the seeds thereof; the resin extracted from any part of such plant; and every compound, (B) The terms “marihuana” and “marijuana” do 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, (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:

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.

Coca leaves, except coca leaves and extracts of coca leaves from which cocaine, ecgonine, and derivatives of ecgonine or their salts have been removed.

Any compound, mixture, or preparation which contains any quantity of any of the substances referred to in subparagraphs (A) through (E).

The term “opium poppy” means the plant of the species Papaver somniferum L., except the seed thereof.

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.

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 controlled substance;

which is an immediate chemical intermediary used or likely to be used in the controlled substance; and

The term “United States, the District of Columbia, and any commonwealth, territory, or possession of the United States.

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.

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.

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 (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.

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 .

(A) Except as provided in subparagraph (C), the term “controlled substance analogue” means a substance—

the chemical structure of which is substantially similar to the chemical structure of a controlled substance in schedule I or 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

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.

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.

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

any substance to the extent not intended for human consumption before such an exemption takes effect with respect to that substance.

(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:

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 acontrolled 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:

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.

(A) a distribution, receipt, sale, importation, or exportation of, or an international transaction involving shipment of, a (i)

a domestic lawful distribution in the usual course of business between agents or employees of a single regulated person;

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;

any category of transaction or any category of transaction for a specific listed chemical or chemicals specified by regulation of the Attorney General as excluded from this definition as unnecessary for enforcement of this subchapter or subchapter II;

(iv) any transaction in a listed chemical that is contained in aFood, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.], subject to clause (v), unless—

the Attorney General has determined under section 814 of this title that the controlled substance; and

any transaction in a scheduled listed chemical product that is a sale at retail by a regulated seller or a distributor required to submit reports under section 830(b)(3) of this title; or

any transaction in a chemical mixture which the Attorney General has by regulation designated as exempt from the application of this subchapter and subchapter II based on a finding that the mixture is formulated in such a way that it cannot be easily used in the illicitcontrolled substance and that the (B)

The term “chemical mixture” means a combination of two or more chemical substances, at least one of which is not a list II chemical, except that such term does not include any combination of a list II chemical with another chemical that is present solely as an impurity.

17α-methyl-*1-dihydrotestosterone (17β-hydroxy-17α-methyl-5α-androst-1-en-3-one) (a.k.a. “17-α-methyl-1-testosterone”);

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 (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).

(i) Subject to clause (ii), a anabolic steroids listed in subparagraph (A) shall be considered to be an anabolic steroid for purposes of this chapter if—

a concentrate, metabolite, or extract of, or a constituent isolated directly from, an herb or other botanical; or

is a dietary ingredient for purposes of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.); and

In accordance with section 885(a) of this title, any person claiming the benefit of an exemption or exception under clause (ii) shall bear the burden of going forward with the evidence with respect to such exemption or exception.

The term “international transaction” means a transaction involving the shipment of a (43) The terms “broker” and “trader” mean a person that assists in arranging an international transaction in a (A)

The term “felony drug offense” means an offense that is punishable by imprisonment for more than one year under any law of the narcotic drugs, marihuana, anabolic steroids, or depressant or stimulant substances.

may be marketed or distributed lawfully in the United States under the Federal, Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.] as a nonprescription drug.

Each reference in clause (i) to ephedrine, pseudoephedrine, or phenylpropanolamine includes each of the salts, optical isomers, and salts of optical isomers of such chemical.

Such term does not include a product described in subparagraph (A) if the product contains a chemical specified in such subparagraph that the Attorney General has under section 811(a) of this title added to any of the schedules under section 812(c) of this title. In the absence of such scheduling by the Attorney General, a chemical specified in such subparagraph may not be considered to be a controlled substance.

The term “regulated seller” means a retail distributor (including a pharmacy or a mobile retail vendor), except that such term does not include an employee or agent of such distributor.

The term “mobile retail vendor” means a person or entity that makes sales at retail from a stand that is intended to be temporary, or is capable of being moved from one location to another, whether the stand is located within or on the premises of a fixed facility (such as a kiosk at a shopping center or an airport) or whether the stand is located on unimproved real estate (such as a lot or field leased for retail purposes).

The term “at retail”, with respect to the sale or purchase of a scheduled listed chemical product, means a sale or purchase for personal use, respectively.

The term “retail distributor” means a grocery store, general merchandise store, distributor relating to ephedrine, pseudoephedrine, or phenylpropanolamine products are limited almost exclusively to sales for personal use, both in number of sales and volume of sales, either directly to walk-in customers or in face-to-face transactions by direct sales.

(B) For purposes of this paragraph, entities are defined by reference to the Standard Industrial Classification (SIC) code, as follows:

The term “Internet” means collectively the myriad of computer and telecommunications facilities, including equipment and operating software, which comprise the interconnected worldwide network of networks that employ the Transmission Control Protocol/Internet Protocol, or any predecessor or successor protocol to such protocol, to communicate information of all kinds by wire or radio.

The term “deliver, distribute, or dispense by means of the Internet” refers, respectively, to any delivery, distribution, or dispensing of a Internet.

means a person, entity, or Internet site, whether in the United States or abroad, that knowingly or intentionally delivers, distributes, or dispenses, or offers or attempts to deliver, distribute, or dispense, a controlled substance by means of the Internet; and

manufacturers orsection 823 of this title who do not dispense controlled substances to an unregistered individual or entity;

nonpharmacy practitioners who are registered under section 823(g) of this title and whose activities are authorized by that registration;

any hospital or other medical facility that is operated by an agency of the United States (including the Armed Forces), provided such hospital or other facility is registered under section 823(g) of this title;

a health care facility owned or operated by an Indian tribe or tribal organization, only to the extent such facility is carrying out a contract or compact under the Indian Self-Determination and Education Assistance Act [25 U.S.C. 5301 et seq.];

any agent or employee of any hospital or facility referred to in clause (iii) or (iv), provided such agent or employee is lawfully acting in the usual course of business or employment, and within the scope of the official duties of such agent or employee, with such hospital or facility, and, with respect to agents or employees of health care facilities specified in clause (iv), only to the extent such individuals are furnishing services pursuant to the contracts or compacts described in such clause;

mere advertisements that do not attempt to facilitate an actual transaction involving a controlled substance;

a person, entity, or Internet site that is not in the United States and does not facilitate the delivery, distribution, or dispensing of a controlled substance by means of the Internet to any person in the United States;

(viii) a pharmacy registered under section 823(g) of this title whose dispensing of controlled substances via the Internet consists solely of—

any other persons for whom the Attorney General and the controls against diversion and otherwise consistent with the public health and safety to exempt from the definition of an “online pharmacy”.

The term “homepage” means the opening or main page or screen of the website of an online pharmacy that is viewable on the Internet.

while the patient is being treated by, and physically located in, a hospital or clinic registered under section 823(g) of this title; and

an employee or contractor of the Department of Veterans Affairs who is acting in the scope of such employment or contract; and

(B) is being conducted while the patient is being treated by, and in the physical presence of, a practitioner—

an employee or contractor of the Department of Veterans Affairs who is acting in the scope of such employment or contract; and

who is an employee or contractor of the Indian Health Service , or is working for an Indian tribe or tribal organization under its contract or compact with the Indian Health Service under the Indian Self-Determination and Education Assistance Act [25 U.S.C. 5301 et seq.];

involves patients located in such areas, and such controlled substances, as the Secretary, with the concurrence of the Attorney General, designates, provided that such designation shall not be subject to the procedures prescribed by subchapter II of chapter 5 of title 5;

is being conducted by a practitioner who has obtained from the Attorney General a special registration under section 831(h) of this title;

that prevents the patient from being in the physical presence of a practitioner registered under section 823(g) of this title who is an employee or contractor of the Veterans Health Administration acting in the usual course of business and employment and within the scope of the official duties or contract of that employee or contractor;

that prevents the patient from being physically present at a hospital or clinic operated by the Department of Veterans Affairs registered under section 823(g) of this title;

during which the primary care practitioner of the patient or a practitioner otherwise practicing telemedicine within the meaning of this paragraph is unable to provide care or consultation; and

that requires immediate intervention by a health care practitioner using controlled substances to prevent what the (ii) by a practitioner that—

is an employee or contractor of the Veterans Health Administration acting within the scope of that employment or contract;

issues a controlled substance prescription in this emergency context that is limited to a maximum of a 5-day supply which may not be extended or refilled; or

is being conducted under any other circumstances that the Attorney General and the controls against diversion and otherwise consistent with the public health and safety.

means the dispensing of a controlled substance in schedule III, IV, or V in accordance with refill instructions issued by asection 829 of this title, as appropriate; and

does not include the issuance of a new prescription to an individual for a controlled substance that individual was previously prescribed.

the pharmacy dispensing that prescription has previously dispensed to the patient a controlled substance other than by means of the Internet and pursuant to the valid prescription of asection 829 of this title (in this paragraph referred to as the “original prescription”);

the pharmacy contacts the practitioner who issued the original prescription at the request of that individual to determine whether the practitioner will authorize the issuance of a new prescription for that individual for the controlled substance described in subparagraph (A); and

the practitioner, acting in the usual course of professional practice, determines there is a legitimate medical purpose for the issuance of the new prescription.

the offender’s release from any term of imprisonment was within 15 years of the commencement of the instant offense.

an offense described in section 3559(c)(2) of title 18 for which the offender served a term of imprisonment of more than 12 months; and

Schedules I, II, III, IV, and V, referred to in pars. (6), (14), (32)(A), (52)(B)(viii), (55), and (56), are set out in section 812(c) of this title.

This subchapter, referred to in introductory provisions and in pars. (34), (35), (39)(A)(iii), (vi), and (54), was in the original “this title”, meaning title II of Pub. L. 91–513, Oct. 27, 1970 , 84 Stat. 1242, and is popularly known as the “Controlled Substances Act”. For complete classification of title II to the Code, see second paragraph of Short Title note set out under section 801 of this title and Tables.

Subchapter II, referred to in par. (39)(A)(iii), (vi), was in the original “title III”, meaning title III of Pub. L. 91–513, Oct. 27, 1970 , 84 Stat. 1285. Part A of title III comprises subchapter II of this chapter. For classification of Part B, consisting of sections 1101 to 1105 of title III, see Tables.

The Federal Food, Drug, and Cosmetic Act, referred to in pars. (39)(A)(iv), (41)(C)(ii)(II), and (45)(A)(ii), is act June 25, 1938, ch. 675, 52 Stat. 1040, which is classified generally to chapter 9 (§ 301 et seq.) of this title. For complete classification of this Act to the Code, see section 301 of this title and Tables.

This chapter, referred to in par. (41)(C)(i), was in the original “this Act”, meaning Pub. L. 91–513, Oct. 27, 1970 , 84 Stat. 1236. For complete classification of this Act to the Code, see Short Title note set out under section 801 of this title and Tables.

The Indian Self-Determination and Education Assistance Act, referred to in pars. (52)(B)(iv) and (54)(C)(i), is Pub. L. 93–638, Jan. 4, 1975 , 88 Stat. 2203, which is classified principally to chapter 46 (§ 5301 et seq.) of Title 25, Indians. For complete classification of this Act to the Code, see Short Title note set out under section 5301 of Title 25 and Tables.

2022—Par. (16)(A). Pub. L. 117–215, § 2(b)(1), substituted “the terms Pub. L. 117–215, § 2(b)(2), substituted “The terms Pub. L. 117–215, § 103(b)(1)(A)(i)(I), substituted “823(g)” for “823(f)” wherever appearing.

Par. (54). Pub. L. 117–215, § 103(b)(1)(A)(ii), substituted “823(g)” for “823(f)” wherever appearing.

2018—Par. (16). Pub. L. 115–334 designated first sentence as subpar. (A), substituted “Subject to subparagraph (B), the” for “The”, inserted subpar. (B) designation, introductory provisions, and cl. (i), designated second sentence as cl. (ii) of subpar. (B), and substituted “the” for “Such term does not include the” in cl. (ii).

Par. (24). Pub. L. 115–271, § 3202(c), substituted “Health and Human Services” for “Health, Education, and Welfare”.

Par. (57). Pub. L. 115–391, § 401(a)(1), added par. (57) defining the term Pub. L. 115–271, § 3292(a), added par. (57) defining the term “suspicious order”.

2016—Par. (18). Pub. L. 114–198 inserted “or Pub. L. 113–260, § 2(a)(1), added cls. (l) to (lxxiv) and redesignated former cl. (xlx) as (lxxv).

2008—Pars. (50) to (56). Pub. L. 110–425 added pars. (50) to (56).

2006—Par. (39)(A)(iv). Pub. L. 109–177, § 712(a)(1)(A)(i), amended cl. (iv) generally. Prior to amendment, cl. (iv) related to transactions involvingPub. L. 109–177, § 712(a)(1)(A)(ii), (iii), added cl. (v) and redesignated former cl. (v) as (vi).

Par. (41)(A)(xvii). Pub. L. 109–162, § 1180(1), substituted “13β-ethyl-17β-hydroxygon-4-en-3-one;” for “13β-ethyl-17α-hydroxygon-4-en-3-one;”.

Par. (41)(A)(xliv). Pub. L. 109–162, § 1180(2), substituted “(17α-methyl-17β-hydroxy-[5α]-androst-2-eno[3,2-c]-pyrazole);” for “(17α-methyl-17α-hydroxy-[5α]-androst-2-eno[3,2-c]-pyrazole);”.

Par. (45). Pub. L. 109–177, §§ 711(a)(1)(B), 712(a)(1)(B), added par. (45) and struck out former par. (45) which defined “ordinary over-the-counter pseudoephedrine or phenylpropanolamine product”.

Pars. (46) to (48). Pub. L. 109–177, §§ 711(a)(1)(B), added pars. (46) to (48). Former par. (46) redesignated (49).

Par. (49). Pub. L. 109–177, § 711(a)(1)(A), (2)(A), redesignated par. (46) as (49), substituted “ephedrine, pseudoephedrine, or” for “pseudoephedrine or” in subpar. (A), redesignated subpar. (C) as (B), and struck out former subpar. (B) which read as follows: “For purposes of this paragraph, sale for personal use means the sale of below-threshold quantities in a single transaction to an individual for legitimate medical use.”

2004—Par. (41). Pub. L. 108–358, § 2(a)(1), realigned margins, added subpar. (A), and struck out former subpar. (A) which defined Pub. L. 108–358, § 2(a)(2), inserted Pub. L. 107–273 repealed Pub. L. 104–294, §§ 604(b)(4), 607(j)(2). See 1996 Amendment note below.

2000—Par. (32)(A). Pub. L. 106–172, § 5(a)(1), substituted “subparagraph (C)” for “subparagraph (B)” in introductory provisions.

Par. (32)(B), (C). Pub. L. 106–172, § 5(a)(2), (3), added subpar. (B) and redesignated former subpar. (B) as (C).

Par. (34)(X), (Y). Pub. L. 106–172, § 3(c), added subpar. (X) and redesignated former subpar. (X) as (Y).

Par. (39)(A)(iv)(II). Pub. L. 106–310 substituted “9 grams” for “24 grams” in two places and inserted before semicolon at end “and sold in package sizes of not more than 3 grams of pseudoephedrine base or 3 grams of phenylpropanolamine base”.

1997—Par. (9)(A). Pub. L. 105–115 redesignated cl. (i) as subpar. (A) and struck out cl. (ii) which read as follows: “any derivative of barbituric acid which has been designated by thesection 352(d) of this title; or”.

1996—Par. (26). Pub. L. 104–294, § 607(j)(1), amended par. (26) generally. Prior to amendment, par. (26) read as follows: “The term Rico, the Trust Territory of the Pacific Islands, and the Canal Zone.”

Par. (34)(P), (S), (U). Pub. L. 104–237, § 209(1), substituted “Isosafrole” for “Insosafrole” in subpar. (P), “N-Methylephedrine” for “N-Methylepherdrine” in subpar. (S), and “Hydriodic acid” for “Hydriotic acid” in subpar. (U).

Par. (35)(G). Pub. L. 104–237, § 209(2), amended subpar. (G) generally, inserting “(or Methyl Ethyl Ketone)” before period at end.

Par. (39)(A)(iv)(I)(aa). Pub. L. 104–237, § 401(a)(1), (b)(1), substituted “, pseudoephedrine or its salts, opticalsection 814(e) of this title, except that any sale of ordinary over-the-counter pseudoephedrine or phenylpropanolamine products byComprehensive Methamphetamine Control Act of 1996);” for “as the only active medicinal ingredient or contains ephedrine or its salts, opticalPub. L. 104–237, § 401(a)(2), (b)(2), inserted “, pseudoephedrine, phenylpropanolamine,” after “ephedrine” and inserted before semicolon “, except that the threshold for any sale of products containing pseudoephedrine or phenylpropanolamine products bysection 830(b)(3) of this title shall be 24 grams of pseudoephedrine or 24 grams of phenylpropanolamine in a single transaction”.

Pars. (43), (44). Pub. L. 104–294, §§ 604(b)(4), 607(j)(2), which provided for amendment to section identical to Pub. L. 104–237, § 401(b)(3), below, were repealed by Pub. L. 107–273, § 4002(c)(1).

1994—Par. (34)(V), (W). Pub. L. 103–322, § 330024(b), realigned margins and capitalized first letter.

Par. (35). Pub. L. 103–322, § 330024(d)(1), made technical correction to directory language of Pub. L. 103–200, § 2(a)(4)(B). See 1993 Amendment note below.

Par. (39)(A)(iv)(II). Pub. L. 103–322, § 330024(a), substituted “; or” for period at end.

Par. (34)(O). Pub. L. 103–200, § 8(1), (2), redesignated subpar. (P) as (O) and struck out former subpar. (O) which read as follows: “D-lysergic acid.”

Par. (34)(P) to (S). Pub. L. 103–200, § 8(2), redesignated subpars. (Q) to (T) as (P) to (S), respectively. Former subpar. (P) redesignated (O).

Par. (34)(T). Pub. L. 103–200, § 8(2), redesignated subpar. (V) as (T). Former subpar. (T) redesignated (S).

Par. (34)(U). Pub. L. 103–200, § 8(1), (2), redesignated subpar. (X) as (U) and struck out former subpar. (U) which read as follows: “N-ethylephedrine.”

Par. (34)(V). Pub. L. 103–200, § 8(2), (4), added subpar. (V) and redesignated former subpar. (V) as (T).

Par. (34)(W). Pub. L. 103–200, § 8(1), (4), added subpar. (W) and struck out former subpar. (W) which read as follows: “N-ethylpseudoephedrine.”

Par. (34)(X). Pub. L. 103–200, § 8(2), (3), redesignated subpar. (Y) as (X) and substituted “through (U)” for “through (X)”.

Par. (34)(Y). Pub. L. 103–200, § 8(2), redesignated subpar. (Y) as (X).

Par. (35). Pub. L. 103–200, § 2(a)(4)(A), (C), substituted Pub. L. 103–200, § 2(a)(4)(B), as amended by Pub. L. 103–322, § 330024(d)(1), inserted “(other than aPub. L. 103–200, § 9(a), amended par. (37) generally. Prior to amendment, par. (37) read as follows: “The term ‘regular supplier’ means, with respect to aPub. L. 103–200, § 2(a)(5), inserted before period at end “or who acts as aPub. L. 103–200, §§ 2(a)(6)(A), 7, in introductory provisions, substituted “importation, or exportation of, or anPub. L. 103–200, § 2(a)(6)(B), inserted “or any category of transaction for a specificPub. L. 103–200, § 2(a)(6)(C), amended cl. (iv) generally. Prior to amendment, cl. (iv) read as follows: “any transaction in aFood, Drug, and Cosmetic Act; or”.

Par. (39)(A)(v). Pub. L. 103–200, § 2(a)(6)(D), inserted before semicolon at end “which the Attorney General has by regulation designated as exempt from the application of this subchapter and subchapter II based on a finding that the mixture is formulated in such a way that it cannot be easily used in the illicitPub. L. 103–200, § 2(a)(7), substituted Pub. L. 103–200, § 2(a)(8), added pars. (42) and (43).

1990—Par. (32)(A). Pub. L. 101–647, § 3599I, substituted “the stimulant” for “the stimulent” in cl. (ii) and “a stimulant” for “a stimulent” in cl. (iii).

Par. (35)(E). Pub. L. 101–647, § 2301(b), struck out subpar. (E) “Hydriodic acid.”

Par. (14). Pub. L. 99–570, § 1870, and Pub. L. 99–646 amended par. (14) identically, substituting “any optical” for “the optical” in second and third sentences.

Par. (25). Pub. L. 99–570, § 1003(b)(1), added par. (25). Former par. (25) redesignated (26).

Pars. (26) to (31). Pub. L. 99–570, § 1003(b)(2), redesignated pars. (25) to (30) as (26) to (31), respectively.

1984—Pars. (14) to (16). Pub. L. 98–473, § 507(a), added par. (14) and redesignated former pars. (14) to (16) as (15) to (17), respectively.

Par. (17). Pub. L. 98–473, § 507, redesignated former par. (16) as (17), and expanded and revised definition of Pub. L. 98–473, § 507(a), redesignated former pars. (17) to (27) as (18) to (28), respectively.

Par. (29). Pub. L. 98–509 which directed the substitution of “one hundred and eighty” for “twenty-one” in par. (28), was executed to par. (29) in view of the redesignation of par. (28) as par. (29) by Pub. L. 98–473.

Pub. L. 98–473, § 507(a), redesignated former par. (28) as (29). Former par. (29) redesignated (30).

Par. (30). Pub. L. 98–473, § 507(a), redesignated former par. (29) as (30).

1979—Par. (4). Pub. L. 96–132 substituted provisions defining “ Drug Enforcement Administration ” for provisions defining “Bureau of Narcotics and DangerousPub. L. 95–633 added par. (29).

1974—Pars. (27), (28). Pub. L. 93–281 added pars. (27) and (28).

“This section [amending this section and sections 841 and 960 of this title], and the amendments made by this section, shall apply to any offense that was committed before the date of enactment of this Act [ Dec. 21, 2018 ], if a sentence for the offense has not been imposed as of such date of enactment.”

Except as provided in paragraph (2), the amendments made by this Act [enacting section 831 of this title and amending this section and sections 823, 827, 829, 841, 843, 882 and 960 of this title] shall take effect 180 days after the date of enactment of this Act [ Oct. 15, 2008 ].

“(A) In general.— Until the earlier of 3 months after the date on which regulations are promulgated to carry out section 311(h) of the Controlled Substances Act [21 U.S.C. 831(h)], as amended by this Act, or 15 months after the date of enactment of this Act—

the definition of the term ‘Controlled Substances Act [21 U.S.C. 802(54)], as amended by this Act, shall not apply.

During the period specified in subparagraph (A), the term ‘Controlled Substances Act (21 U.S.C. 802)) (other than a pharmacist) who is at a location remote from the patient and is communicating with the patient, or health care professional who is treating the patient, using a telecommunications system referred to in section 1834(m) of the Social Security Act (42 U.S.C. 1395m(m)), if thesection 410.78(a)(3) of title 42, Code of Federal Regulations.

Nothing in this subsection may be construed to create a precedent that any specific course of conduct constitutes the ‘Controlled Substances Act, as amended by this Act) after the end of the period specified in subparagraph (A).”

“The amendments made by this section [amending this section, section 811 of this title, and provisions set out as a note under this section] shall take effect 90 days after the date of enactment of this Act [ Oct. 22, 2004 ].”

Pub. L. 107–273, div. B, title IV, § 4002(c)(1), Nov. 2, 2002 , 116 Stat. 1808, provided that the amendment made by section 4002(c)(1) is effective Oct. 11, 1996 .

“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 ].”

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.

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.

“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 Effective Date of 1994 Amendment

“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 ].”

“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 ].”

“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 ].”

“Except as otherwise provided in this subtitle, this subtitle [subtitle A (§§ 6051–6061) of title VI of Pub. L. 100–690, enacting section 971 of this title, amending this section and sections 830, 841 to 843, 872, 876, 881, 960, and 961 of this title, and enacting provisions set out as notes under this section and section 971 of this title] shall take effect 120 days after the enactment of this Act [ Nov. 18, 1988 ].”

Amendment by Pub. L. 95–633 effective on date theJuly 15, 1980 ], see section 112 of Pub. L. 95–633, set out as an Effective Date note under section 801a of this title.

“The Attorney General may promulgate and enforce any rules, regulations, and procedures which may be necessary and appropriate for the efficient execution of functions under this Act [see Short Title of 2008 Amendment note set out under section 801 of this title] or the amendments made by this Act, and, with the concurrence of thePub. L. 98–509, title III, § 301(b), Oct. 19, 1984 , 98 Stat. 2364, provided that:

“The 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 Construction of 2008 Amendment

“Nothing in this Act [see Short Title of 2008 Amendment note set out under section 801 of this title] or the amendments made by this Act shall be construed as authorizing, prohibiting, or limiting the use of electronic prescriptions for Preservation of State Authority To Regulate Scheduled Listed Chemicals

“This section [amending this section and sections 830, 841, 842, and 844 of this title and enacting provisions set out as notes under sections 830 and 844 of this title] and the amendments made by this section may not be construed as having any legal effect on section 708 of the Controlled Substances Act [21 U.S.C. 903] as applied to the regulation of scheduled21 U.S.C. 802(45)]).”

“(a) Study.— The Attorney General shall conduct a study of the use of ordinary, over-the-counter pseudoephedrine and phenylpropanolamine products in the clandestine “(1)

Information submitted voluntarily from the pharmaceutical and retail industries involved in the “(b) Report.—

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).

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.

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 “(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 “(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 “(B)

the best practical method of preventing such use is the establishment of single-transaction limits for “(2) Due process.—

The Attorney General shall establish the single-transaction limit under paragraph (1) only after notice, comment, and an informal hearing.”

Regulation of Retail Sales of Certain Precursor Chemicals; Effect on Thresholds; Combination Ephedrine Products

Pub. L. 104–237, title IV, § 401(d)–(f), Oct. 3, 1996 , 110 Stat. 3108, which authorized the Attorney General to establish a single-transaction limit of 24 grams for pseudoephedrine, phenylpropanolamine, and combination ephedrine products forPub. L. 109–177, title VII, § 712(b), Mar. 9, 2006 , 120 Stat. 264.

“(a) Drugs for Treatment of Rare Diseases.— If the Attorney General finds that a Controlled Substances Act (as added by section 2 [1902] of this Act) is—

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

does not have a significant potential for abuse, the Attorney General may exempt such Controlled Substances Act as may be necessary to ensure adequate supplies of such “(b) Date of Issuance of Regulations.—

The Attorney General shall issue regulations implementing this section not later than 45 days after the date of enactment of this Act [ Nov. 29, 1990 ], except that the regulations required under section 3(a) [former 1903(a)] shall be issued not later than 180 days after the date of enactment of this Act.”