21 U.S.C. § 802 — Definitions

Page 782 TITLE 21—FOOD AND DRUGS § 801a ing it into counterfeit opioid pills. Because fentanyl is lethal in even miniscule doses, this is an extremely deadly tactic, as it too often causes users to ingest a fatal amount unknowingly. SEC. 2. Agency Action. The Secretary of Health and Human Services shall, consistent with section 319 of the Public Health Service Act, 42 U.S.C. 247d, consider declaring that the drug demand and opioid crisis de- scribed in section 1 of this memorandum constitutes a Public Health Emergency. Additionally, the heads of executive departments and agencies, as appropriate and consistent with law, shall exercise all appropriate emergency authorities, as well as other relevant au- thorities, to reduce the number of deaths and minimize the devastation the drug demand and opioid crisis in- flicts upon American communities. SEC. 3. General Provisions. (a) Nothing in this memo- randum shall be construed to impair or otherwise af- fect: (i) the authority granted by law to an executive de- partment or agency, or the head thereof; or (ii) the functions of the Director of the Office of Man- agement and Budget relating to budgetary, administra- tive, or legislative proposals. (b) This memorandum shall be implemented con- sistent with applicable law and subject to the avail- ability of appropriations. (c) This memorandum is not intended to, and does not, create any right or benefit, substantive or proce- dural, enforceable at law or in equity by any party against the United States, its departments, agencies, or entities, its officers, employees, or agents, or any other person. (d) The Secretary of Health and Human Services is hereby authorized and directed to publish this memo- randum in the Federal Register. DONALD J. TRUMP. § 801a. Congressional findings and declarations: psychotropic substances The Congress makes the following findings and declarations: (1) The Congress has long recognized the danger involved in the manufacture, distribu- tion, and use of certain psychotropic sub- stances for nonscientific and nonmedical pur- poses, and has provided strong and effective legislation to control illicit trafficking and to regulate legitimate uses of psychotropic sub- stances in this country. Abuse of psychotropic substances has become a phenomenon common to many countries, however, and is not con- fined to national borders. It is, therefore, es- sential that the United States cooperate with other nations in establishing effective controls over international traffic in such substances. (2) The United States has joined with other countries in executing an international trea- ty, entitled the Convention on Psychotropic Substances and signed at Vienna, Austria, on February 21, 1971, which is designed to estab- lish suitable controls over the manufacture, distribution, transfer, and use of certain psy- chotropic substances. The Convention is not self-executing, and the obligations of the United States thereunder may only be per- formed pursuant to appropriate legislation. It is the intent of the Congress that the amend- ments made by this Act, together with exist- ing law, will enable the United States to meet all of its obligations under the Convention and that no further legislation will be necessary for that purpose. (3) In implementing the Convention on Psy- chotropic Substances, the Congress intends that, consistent with the obligations of the United States under the Convention, control of psychotropic substances in the United States should be accomplished within the framework of the procedures and criteria for classification of substances provided in the Comprehensive Drug Abuse Prevention and Control Act of 1970 [21 U.S.C. 801 et seq.]. This will insure that (A) the availability of psycho- tropic substances to manufacturers, distribu- tors, dispensers, and researchers for useful and legitimate medical and scientific purposes will not be unduly restricted; (B) nothing in the Convention will interfere with bona fide re- search activities; and (C) nothing in the Con- vention will interfere with ethical medical practice in this country as determined by the Secretary of Health and Human Services on the basis of a consensus of the views of the American medical and scientific community. (Pub. L. 95–633, title I, § 101, Nov. 10, 1978, 92 Stat. 3768; Pub. L. 96–88, title V, § 509(b), Oct. 17, 1979, 93 Stat. 695.) Editorial Notes REFERENCES IN TEXT This Act, referred to in par. (2), is Pub. L. 95–633, Nov. 10, 1978, 92 Stat. 2768, as amended, known as the Psy- chotropic Substances Act of 1978, which enacted sec- tions 801a, 830, and 852 of this title, amended sections 352, 802, 811, 812, 823, 827, 841 to 843, 872, 881, 952, 953, and 965 of this title and section 242a of Title 42, The Public Health and Welfare, repealed section 830 of this title ef- fective Jan. 1, 1981, and enacted provisions set out as notes under sections 801, 801a, 812, and 830 of this title. For complete classification of this Act to the Code, see Short Title of 1978 Amendment note set out under sec- tion 801 of this title and Tables. The Comprehensive Drug Abuse Prevention and Con- trol Act of 1970, referred to in par. (3), is Pub. L. 91–513, Oct. 27, 1970, 84 Stat. 1236, which is classified prin- cipally to this chapter [§ 801 et seq.]. For complete clas- sification of this Act to the Code, see Short Title note set out under section 801 of this title and Tables. CODIFICATION Section was enacted as a part of the Psychotropic Substances Act of 1978, and not as a part of the Con- trolled Substances Act which comprises this sub- chapter. Statutory Notes and Related Subsidiaries CHANGE OF NAME ‘‘Secretary of Health and Human Services’’ sub- stituted for ‘‘Secretary of Health, Education, and Wel- fare’’ in par. (3) pursuant to section 509(b) of Pub. L. 96–88, which is classified to section 3508(b) of Title 20, Education. EFFECTIVE DATE Pub. L. 95–633, title I, § 112, Nov. 10, 1978, 92 Stat. 3774, provided that: ‘‘This title [enacting this section and section 852 of this title, amending sections 352, 802, 811, 812, 823, 827, 872, 952, and 953 of this title and section 242a of Title 42, The Public Health and Welfare, and en- acting provisions set out as notes under sections 801 and 812 of this title] and the amendments made by this title shall take effect on the date the Convention on Psychotropic Substances, signed at Vienna, Austria on February 21, 1971, enters into force in respect to the United States.’’ [The Convention entered into force in respect to the United States on July 15, 1980.] § 802. Definitions As used in this subchapter: Page 783 TITLE 21—FOOD AND DRUGS § 802 (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 di- rection and in the presence of the practitioner, whether such application be by injection, inha- lation, ingestion, or any other means. (3) The term ‘‘agent’’ means an authorized per- son 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 em- ployee of the carrier or warehouseman, when acting in the usual and lawful course of the car- rier’s or warehouseman’s business. (4) The term ‘‘Drug Enforcement Administra- tion’’ means the Drug Enforcement Administra- tion 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, wheth- er by transfer from another schedule or other- wise. (6) The term ‘‘controlled substance’’ means a drug or other substance, or immediate pre- cursor, included in schedule I, II, III, IV, or V of part B of this subchapter. The term does not in- clude 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 like- ness 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 pur- ports or is represented to be the product of, or to have been distributed by, such other manu- facturer, 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 relation- ship. (9) The term ‘‘depressant or stimulant sub- stance’’ means— (A) a drug which contains any quantity of barbituric acid or any of the salts of barbi- turic 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 op- tical isomer of amphetamine; or (iii) any sub- stance which the Attorney General, after in- vestigation, has found to be, and by regulation designated as, habit forming because of its stimulant effect on the central nervous sys- tem; 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 regu- lation 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 re- search subject by, or pursuant to the lawful order of, a practitioner, including the pre- scribing and administering of a controlled sub- stance 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 sub- stance 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 deliv- ers 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 iso- mer, except as used in schedule I(c) and schedule II(a)(4). As used in schedule I(c), the term ‘‘iso- mer’’ means any optical, positional, or geo- metric isomer. As used in schedule II(a)(4), the term ‘‘isomer’’ means any optical or geometric isomer. (15) The term ‘‘manufacture’’ means the pro- duction, preparation, propagation, compounding, or processing of a drug or other substance, either directly or indirectly or by ex- traction 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 re- packaging of such substance or labeling or re- labeling of its container; except that such term does not include the preparation, compounding, packaging, or labeling of a drug or other sub- stance 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 prac- tice. The term ‘‘manufacturer’’ means a person who manufactures a drug or other substance. (16)(A) Subject to subparagraph (B), the terms ‘‘marihuana’’ and ‘‘marijuana’’ mean all parts of the plant Cannabis sativa L., whether growing or not; the seeds thereof; the resin extracted from any part of such plant; and every com- pound, manufacture, salt, derivative, mixture, or preparation of such plant, its seeds or resin. (B) The terms ‘‘marihuana’’ and ‘‘marijuana’’ do not include— (i) hemp, as defined in section 1639o of title 7; or (ii) the mature stalks of such plant, fiber produced from such stalks, oil or cake made from the seeds of such plant, any other com- pound, 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 indi- Page 784 TITLE 21—FOOD AND DRUGS § 802 rectly by extraction from substances of vege- table origin, or independently by means of chemical synthesis, or by a combination of ex- traction 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 iso- mers, esters, ethers, and salts is possible with- in the specific chemical designation. Such term does not include the isoquinoline alka- loids of opium. (B) Poppy straw and concentrate of poppy straw. (C) Coca leaves, except coca leaves and ex- tracts of coca leaves from which cocaine, ecgo- nine, 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, iso- mers, and salts of isomers. (F) Any compound, mixture, or preparation which contains any quantity of any of the sub- stances referred to in subparagraphs (A) through (E). (18) The term ‘‘opiate’’ or ‘‘opioid’’ means any drug or other substance having an addiction- forming or addiction-sustaining liability similar to morphine or being capable of conversion into a drug having such addiction-forming or addic- tion-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 mow- ing. (21) The term ‘‘practitioner’’ means a physi- cian, dentist, veterinarian, scientific investi- gator, pharmacy, hospital, or other person li- censed, registered, or otherwise permitted, by the United States or the jurisdiction in which he practices or does research, to distribute, dis- pense, conduct research with respect to, admin- ister, or use in teaching or chemical analysis, a controlled substance in the course of profes- sional practice or research. (22) The term ‘‘production’’ includes the man- ufacture, planting, cultivation, growing, or har- vesting 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 pri- marily for use, in the manufacture of a con- trolled substance; (B) which is an immediate chemical inter- mediary used or likely to be used in the manu- facture of such controlled substance; and (C) the control of which is necessary to pre- vent, curtail, or limit the manufacture of such controlled substance. (24) The term ‘‘Secretary’’, unless the context otherwise indicates, means the Secretary of Health and Human Services. (25) The term ‘‘serious bodily injury’’ means bodily injury which involves— (A) a substantial risk of death; (B) protracted and obvious disfigurement; or (C) protracted loss or impairment of the function of a bodily member, organ, or mental faculty. (26) The term ‘‘State’’ means a State of the United States, the District of Columbia, and any commonwealth, territory, or possession of the United States. (27) The term ‘‘ultimate user’’ means a person who has lawfully obtained, and who possesses, a controlled substance for his own use or for the use of a member of his household or for an ani- mal owned by him or by a member of his house- hold. (28) The term ‘‘United States’’, when used in a geographic sense, means all places and waters, continental or insular, subject to the jurisdic- tion 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 treat- ment of an individual for dependence upon her- oin 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 psy- chological 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 Psycho- tropic Substances signed at Vienna, Austria, on February 21, 1971; and the term ‘‘Single Conven- tion on Narcotic Drugs’’ means the Single Con- vention 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 sub- stantially 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 hal- lucinogenic effect on the central nervous sys- tem 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 hallucino- genic 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 con- trolled substance in schedule I or II. (B) The designation of gamma butyrolactone or any other chemical as a listed chemical pur- suant to paragraph (34) or (35) does not preclude a finding pursuant to subparagraph (A) of this paragraph that the chemical is a controlled sub- stance analogue. (C) Such term does not include— (i) a controlled substance; (ii) any substance for which there is an ap- proved new drug application; Page 785 TITLE 21—FOOD AND DRUGS § 802 (iii) with respect to a particular person any substance, if an exemption is in effect for in- vestigational use, for that person, under sec- tion 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 exemp- tion takes effect with respect to that sub- stance. (33) The term ‘‘listed chemical’’ means any list I chemical or any list II chemical. (34) The term ‘‘list I chemical’’ means a chem- ical specified by regulation of the Attorney Gen- eral as a chemical that is used in manufacturing a controlled substance in violation of this sub- chapter and is important to the manufacture of the controlled substances, and such term in- cludes (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 iso- mers, 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 op- tical isomer of the chemicals listed in sub- paragraphs (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 con- trolled substance in violation of this subchapter, and such term includes (until otherwise speci- fied by regulation of the Attorney General, as considered appropriate by the Attorney General or upon petition to the Attorney General by any person) the following chemicals: (A) Acetic anhydride. (B) Acetone. (C) Benzyl chloride. (D) Ethyl ether. (E) Repealed. Pub. L. 101–647, title XXIII, § 2301(b), Nov. 29, 1990, 104 Stat. 4858. (F) Potassium permanganate. (G) 2-Butanone (or Methyl Ethyl Ketone). (H) Toluene. (I) Iodine. (J) Hydrochloric gas. (36) The term ‘‘regular customer’’ means, with respect to a regulated person, a customer with whom the regulated person has an established business relationship that is reported to the At- torney 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 list- ed chemical that is reported to the Attorney General. (38) The term ‘‘regulated person’’ means a per- son 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 trans- action 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 trans- action involving shipment of, a listed chem- ical, or if the Attorney General establishes a threshold amount for a specific listed chem- ical, a threshold amount, including a cumu- lative threshold amount for multiple trans- actions (as determined by the Attorney Gen- eral, in consultation with the chemical indus- try and taking into consideration the quan- tities 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 ware- houseman, except that if the carriage or storage is in connection with the distribu- tion, importation, or exportation of a listed chemical to a third person, this clause does not relieve a distributor, importer, or ex- porter 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 regula- tion of the Attorney General as excluded from this definition as unnecessary for en- forcement of this subchapter or subchapter II; (iv) any transaction in a listed chemical that is contained in a drug that may be mar- keted or distributed lawfully in the United States under the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.], subject to clause (v), unless— (I) the Attorney General has determined under section 814 of this title that the drug or group of drugs is being diverted to ob- tain the listed chemical for use in the il- licit production of a controlled substance; and Page 786 TITLE 21—FOOD AND DRUGS § 802 (II) the quantity of the listed chemical contained in the drug included in the transaction or multiple transactions equals or exceeds the threshold established for that chemical by the Attorney General; (v) any transaction in a scheduled listed chemical product that is a sale at retail by a regulated seller or a distributor required to submit reports under section 830(b)(3) of this title; or (vi) any transaction in a chemical mixture which the Attorney General has by regula- tion designated as exempt from the applica- tion of this subchapter and subchapter II based on a finding that the mixture is for- mulated in such a way that it cannot be eas- ily used in the illicit production of a con- trolled substance and that the listed chem- ical or chemicals contained in the mixture cannot be readily recovered; and (B) a distribution, importation, or expor- tation of a tableting machine or encapsulating machine. (40) The term ‘‘chemical mixture’’ means a combination of two or more chemical sub- stances, at least one of which is not a list I chemical or a list II chemical, except that such term does not include any combination of a list I chemical or a list II chemical with another chemical that is present solely as an impurity. (41)(A) The term ‘‘anabolic steroid’’ means any drug or hormonal substance, chemically and pharmacologically related to testosterone (other than estrogens, progestins, corticosteroids, and dehydroepiandrosterone), and includes— (i) androstanediol— (I) 3β,17β-dihydroxy-5α-androstane; and (II) 3α,17β-dihydroxy-5α-androstane; (ii) androstanedione (5α-androstan-3,17- dione); (iii) androstenediol— (I) 1-androstenediol (3β,17β-dihydroxy-5α- androst-1-ene); (II) 1-androstenediol (3α,17β-dihydroxy-5α- androst-1-ene); (III) 4-androstenediol (3β,17β-dihydroxy- androst-4-ene); and (IV) 5-androstenediol (3β,17β-dihydroxy- androst-5-ene); (iv) androstenedione— (I) 1-androstenedione ([5α]-androst-1-en- 3,17-dione); (II) 4-androstenedione (androst-4-en-3,17- dione); and (III) 5-androstenedione (androst-5-en-3,17- dione); (v) bolasterone (7α,17α-dimethyl-17β- hydroxyandrost-4-en-3-one); (vi) boldenone (17β-hydroxyandrost-1,4,- diene-3-one); (vii) calusterone (7β,17α-dimethyl-17β- hydroxyandrost-4-en-3-one); (viii) clostebol (4-chloro-17β-hydroxyandrost- 4-en-3-one); (ix) dehydrochloromethyltestosterone (4- chloro-17β-hydroxy-17α-methyl-androst-1,4- dien-3-one); (x) >1-dihydrotestosterone (a.k.a. ‘‘1-testos- terone’’) (17β-hydroxy-5α-androst-1-en-3-one); (xi) 4-dihydrotestosterone (17β-hydroxy- androstan-3-one); (xii) drostanolone (17β-hydroxy-2α-methyl- 5α-androstan-3-one); (xiii) ethylestrenol (17α-ethyl-17β- hydroxyestr-4-ene); (xiv) fluoxymesterone (9-fluoro-17α-methyl- 11β,17β-dihydroxyandrost-4-en-3-one); (xv) formebolone (2-formyl-17α-methyl- 11α,17β-dihydroxyandrost-1,4-dien-3-one); (xvi) furazabol (17α-methyl-17β- hydroxyandrostano[2,3-c]-furazan); (xvii) 13β-ethyl-17β-hydroxygon-4-en-3-one; (xviii) 4-hydroxytestosterone (4,17β- dihydroxy-androst-4-en-3-one); (xix) 4-hydroxy-19-nortestosterone (4,17β- dihydroxy-estr-4-en-3-one); (xx) mestanolone (17α-methyl-17β-hydroxy- 5α-androstan-3-one); (xxi) mesterolone (1α-methyl-17β-hydroxy- [5α]-androstan-3-one); (xxii) methandienone (17α-methyl-17β- hydroxyandrost-1,4-dien-3-one); (xxiii) methandriol (17α-methyl-3β,17β- dihydroxyandrost-5-ene); (xxiv) methenolone (1-methyl-17β-hydroxy- 5α-androst-1-en-3-one); (xxv) 17α-methyl-3β, 17β-dihydroxy-5α-andro- stane; (xxvi) 17α-methyl-3α,17β-dihydroxy-5α-andro- stane; (xxvii) 17α-methyl-3β,17β-dihydroxyandrost- 4-ene. (xxviii) 17α-methyl-4-hydroxynandrolone (17α-methyl-4-hydroxy-17β-hydroxyestr-4-en-3- one); (xxix) methyldienolone (17α-methyl-17β- hydroxyestra-4,9(10)-dien-3-one); (xxx) methyltrienolone (17α-methyl-17β- hydroxyestra-4,9-11-trien-3-one); (xxxi) methyltestosterone (17α-methyl-17β- hydroxyandrost-4-en-3-one); (xxxii) mibolerone (7α,17α-dimethyl-17β- hydroxyestr-4-en-3-one); (xxxiii) 17α-methyl->1-dihydrotestosterone (17β-hydroxy-17α-methyl-5α-androst-1-en-3- one) (a.k.a. ‘‘17-α-methyl-1-testosterone’’); (xxxiv) nandrolone (17β-hydroxyestr-4-en-3- one); (xxxv) norandrostenediol— (I) 19-nor-4-androstenediol (3β, 17β- dihydroxyestr-4-ene); (II) 19-nor-4-androstenediol (3α, 17β- dihydroxyestr-4-ene); (III) 19-nor-5-androstenediol (3β, 17β- dihydroxyestr-5-ene); and (IV) 19-nor-5-androstenediol (3α, 17β- dihydroxyestr-5-ene); (xxxvi) norandrostenedione— (I) 19-nor-4-androstenedione (estr-4-en-3,17- dione); and (II) 19-nor-5-androstenedione (estr-5-en- 3,17-dione; (xxxvii) norbolethone (13β,17α-diethyl-17β- hydroxygon-4-en-3-one); (xxxviii) norclostebol (4-chloro-17β- hydroxyestr-4-en-3-one); (xxxix) norethandrolone (17α-ethyl-17β- hydroxyestr-4-en-3-one); (xl) normethandrolone (17α-methyl-17β- hydroxyestr-4-en-3-one); Page 787 TITLE 21—FOOD AND DRUGS § 802 (xli) oxandrolone (17α-methyl-17β-hydroxy-2- oxa-[5α]-androstan-3-one); (xlii) oxymesterone (17α-methyl-4,17β- dihydroxyandrost-4-en-3-one); (xliii) oxymetholone (17α-methyl-2- hydroxymethylene-17β-hydroxy-[5α]- androstan-3-one); (xliv) stanozolol (17α-methyl-17β-hydroxy- [5α]-androst-2-eno[3,2-c]-pyrazole); (xlv) stenbolone (17β-hydroxy-2-methyl-[5α]- androst-1-en-3-one); (xlvi) testolactone (13-hydroxy-3-oxo-13,17- secoandrosta-1,4-dien-17-oic acid lactone); (xlvii) testosterone (17β-hydroxyandrost-4- en-3-one); (xlviii) tetrahydrogestrinone (13β,17α- diethyl-17β-hydroxygon-4,9,11-trien-3-one); (xlix) trenbolone (17β-hydroxyestr-4,9,11- trien-3-one); (l) 5α-Androstan-3,6,17-trione; (li) 6-bromo-androstan-3,17-dione; (lii) 6-bromo-androsta-1,4-diene-3,17-dione; (liii) 4-chloro-17α-methyl-androsta-1,4-diene- 3,17β-diol; (liv) 4-chloro-17α-methyl-androst-4-ene- 3β,17β-diol; (lv) 4-chloro-17α-methyl-17β-hydroxy- androst-4-en-3-one; (lvi) 4-chloro-17α-methyl-17β-hydroxy- androst-4-ene-3,11-dione; (lvii) 4-chloro-17α-methyl-androsta-1,4-diene- 3,17β-diol; (lviii) 2α,17α-dimethyl-17β-hydroxy-5α- androstan-3-one; (lix) 2α,17α-dimethyl-17β-hydroxy-5β- androstan-3-one; (lx) 2α,3α-epithio-17α-methyl-5α-androstan- 17β-ol; (lxi) [3,2-c]-furazan-5α-androstan-17β-ol; (lxii) 3β-hydroxy-estra-4,9,11-trien-17-one; (lxiii) 17α-methyl-androst-2-ene-3,17β-diol; (lxiv) 17α-methyl-androsta-1,4-diene-3,17β- diol; (lxv) Estra-4,9,11-triene-3,17-dione; (lxvi) 18a-Homo-3-hydroxy-estra-2,5(10)-dien- 17-one; (lxvii) 6α-Methyl-androst-4-ene-3,17-dione; (lxviii) 17α-Methyl-androstan-3- hydroxyimine-17β-ol; (lxix) 17α-Methyl-5α-androstan-17β-ol; (lxx) 17β-Hydroxy-androstano[2,3-d]isoxazole; (lxxi) 17β-Hydroxy-androstano[3,2- c]isoxazole; (lxxii) 4-Hydroxy-androst-4-ene-3,17- dione[3,2-c]pyrazole-5α-androstan-17β-ol; (lxxiii) [3,2-c]pyrazole-androst-4-en-17β-ol; (lxxiv) [3,2-c]pyrazole-5α-androstan-17β-ol; and (lxxv) any salt, ester, or ether of a drug or substance described in this paragraph. The substances excluded under this subpara- graph may at any time be scheduled by the At- torney General in accordance with the authority and requirements of subsections (a) through (c) of section 811 of this title. (B)(i) Except as provided in clause (ii), such term does not include an anabolic steroid which is expressly intended for administration through implants to cattle or other nonhuman species and which has been approved by the Secretary of Health and Human Services for such administra- tion. (ii) If any person prescribes, dispenses, or dis- tributes such steroid for human use, such person shall be considered to have prescribed, dis- pensed, or distributed an anabolic steroid within the meaning of subparagraph (A). (C)(i) Subject to clause (ii), a drug or hor- monal substance (other than estrogens, progestins, corticosteroids, and dehydroepiandrosterone) that is not listed in subparagraph (A) and is derived from, or has a chemical structure substantially similar to, 1 or more anabolic steroids listed in subparagraph (A) shall be considered to be an anabolic steroid for purposes of this chapter if— (I) the drug or substance has been created or manufactured with the intent of producing a drug or other substance that either— (aa) promotes muscle growth; or (bb) otherwise causes a pharmacological effect similar to that of testosterone; or (II) the drug or substance has been, or is in- tended to be, marketed or otherwise promoted in any manner suggesting that consuming it will promote muscle growth or any other phar- macological effect similar to that of testos- terone. (ii) A substance shall not be considered to be a drug or hormonal substance for purposes of this subparagraph if it— (I) is— (aa) an herb or other botanical; (bb) a concentrate, metabolite, or extract of, or a constituent isolated directly from, an herb or other botanical; or (cc) a combination of 2 or more substances described in item (aa) or (bb); (II) is a dietary ingredient for purposes of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.); and (III) is not anabolic or androgenic. (iii) In accordance with section 885(a) of this title, any person claiming the benefit of an ex- emption or exception under clause (ii) shall bear the burden of going forward with the evidence with respect to such exemption or exception. (42) The term ‘‘international transaction’’ means a transaction involving the shipment of a listed chemical across an international border (other than a United States border) in which a broker or trader located in the United States participates. (43) The terms ‘‘broker’’ and ‘‘trader’’ mean a person that assists in arranging an international transaction in a listed chemical by— (A) negotiating contracts; (B) serving as an agent or intermediary; or (C) bringing together a buyer and seller, a buyer and transporter, or a seller and trans- porter. (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 pro- hibits or restricts conduct relating to narcotic drugs, marihuana, anabolic steroids, or depres- sant or stimulant substances. (45)(A) The term ‘‘scheduled listed chemical product’’ means, subject to subparagraph (B), a product that— Page 788 TITLE 21—FOOD AND DRUGS § 802 (i) contains ephedrine, pseudoephedrine, or phenylpropanolamine; and (ii) may be marketed or distributed lawfully in the United States under the Federal, Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.] as a nonprescription drug. Each reference in clause (i) to ephedrine, pseudoephedrine, or phenylpropanolamine in- cludes each of the salts, optical isomers, and salts of optical isomers of such chemical. (B) Such term does not include a product de- scribed in subparagraph (A) if the product con- tains a chemical specified in such subparagraph that the Attorney General has under section 811(a) of this title added to any of the schedules under section 812(c) of this title. In the absence of such scheduling by the Attorney General, a chemical specified in such subparagraph may not be considered to be a controlled substance. (46) The term ‘‘regulated seller’’ means a re- tail distributor (including a pharmacy or a mo- bile retail vendor), except that such term does not include an employee or agent of such dis- tributor. (47) The term ‘‘mobile retail vendor’’ means a person or entity that makes sales at retail from a stand that is intended to be temporary, or is capable of being moved from one location to an- other, whether the stand is located within or on the premises of a fixed facility (such as a kiosk at a shopping center or an airport) or whether the stand is located on unimproved real estate (such as a lot or field leased for retail purposes). (48) The term ‘‘at retail’’, with respect to the sale or purchase of a scheduled listed chemical product, means a sale or purchase for personal use, respectively. (49)(A) The term ‘‘retail distributor’’ means a grocery store, general merchandise store, drug store, or other entity or person whose activities as a distributor relating to ephedrine, pseudoephedrine, or phenylpropanolamine prod- ucts are limited almost exclusively to sales for personal use, both in number of sales and vol- ume of sales, either directly to walk-in cus- tomers or in face-to-face transactions by direct sales. (B) For purposes of this paragraph, entities are defined by reference to the Standard Indus- trial 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. (50) The term ‘‘Internet’’ means collectively the myriad of computer and telecommuni- cations facilities, including equipment and oper- ating software, which comprise the inter- connected worldwide network of networks that employ the Transmission Control Protocol/ Internet Protocol, or any predecessor or suc- cessor protocol to such protocol, to commu- nicate information of all kinds by wire or radio. (51) The term ‘‘deliver, distribute, or dispense by means of the Internet’’ refers, respectively, to any delivery, distribution, or dispensing of a controlled substance that is caused or facili- tated by means of the Internet. (52) The term ‘‘online pharmacy’’— (A) means a person, entity, or Internet site, whether in the United States or abroad, that knowingly or intentionally delivers, distrib- utes, or dispenses, or offers or attempts to de- liver, distribute, or dispense, a controlled sub- stance by means of the Internet; and (B) does not include— (i) manufacturers or distributors reg- istered under subsection (a), (b), (e), or (f) of section 823 of this title who do not dispense controlled substances to an unregistered in- dividual or entity; (ii) nonpharmacy practitioners who are registered under section 823(g) of this title and whose activities are authorized by that registration; (iii) any hospital or other medical facility that is operated by an agency of the United States (including the Armed Forces), pro- vided such hospital or other facility is reg- istered under section 823(g) of this title; (iv) a health care facility owned or oper- ated by an Indian tribe or tribal organiza- tion, only to the extent such facility is car- rying out a contract or compact under the Indian Self-Determination and Education Assistance Act [25 U.S.C. 5301 et seq.]; (v) any agent or employee of any hospital or facility referred to in clause (iii) or (iv), provided such agent or employee is lawfully acting in the usual course of business or em- ployment, and within the scope of the offi- cial duties of such agent or employee, with such hospital or facility, and, with respect to agents or employees of health care facili- ties specified in clause (iv), only to the ex- tent such individuals are furnishing services pursuant to the contracts or compacts de- scribed in such clause; (vi) mere advertisements that do not at- tempt to facilitate an actual transaction in- volving a controlled substance; (vii) a person, entity, or Internet site that is not in the United States and does not fa- cilitate the delivery, distribution, or dis- pensing 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 con- trolled substances via the Internet consists solely of— (I) refilling prescriptions for controlled substances in schedule III, IV, or V, as de- fined in paragraph (55); or (II) filling new prescriptions for con- trolled substances in schedule III, IV, or V, as defined in paragraph (56); or (ix) any other persons for whom the Attor- ney General and the Secretary have jointly, by regulation, found it to be consistent with effective controls against diversion and oth- erwise consistent with the public health and safety to exempt from the definition of an ‘‘online pharmacy’’. (53) The term ‘‘homepage’’ means the opening or main page or screen of the website of an on- line pharmacy that is viewable on the Internet. (54) The term ‘‘practice of telemedicine’’ means, for purposes of this subchapter, the prac- Page 789 TITLE 21—FOOD AND DRUGS § 802 tice of medicine in accordance with applicable Federal and State laws by a practitioner (other than a pharmacist) who is at a location remote from the patient and is communicating with the patient, or health care professional who is treat- ing the patient, using a telecommunications system referred to in section 1395m(m) of title 42, which practice— (A) is being conducted— (i) while the patient is being treated by, and physically located in, a hospital or clin- ic registered under section 823(g) of this title; and (ii) by a practitioner— (I) acting in the usual course of profes- sional practice; (II) acting in accordance with applicable State law; and (III) registered under section 823(g) of this title in the State in which the patient is located, unless the practitioner— (aa) is exempted from such registra- tion in all States under section 822(d) of this title; or (bb) is— (AA) an employee or contractor of the Department of Veterans Affairs who is acting in the scope of such em- ployment or contract; and (BB) registered under section 823(g) of this title in any State or is utilizing the registration of a hospital or clinic operated by the Department of Vet- erans Affairs registered under section 823(g) of this title; (B) is being conducted while the patient is being treated by, and in the physical presence of, a practitioner— (i) acting in the usual course of profes- sional practice; (ii) acting in accordance with applicable State law; and (iii) registered under section 823(g) of this title in the State in which the patient is lo- cated, unless the practitioner— (I) is exempted from such registration in all States under section 822(d) of this title; or (II) is— (aa) an employee or contractor of the Department of Veterans Affairs who is acting in the scope of such employment or contract; and (bb) registered under section 823(g) of this title in any State or is using the registration of a hospital or clinic oper- ated by the Department of Veterans Af- fairs registered under section 823(g) of this title; (C) is being conducted by a practitioner— (i) who is an employee or contractor of the Indian Health Service, or is working for an Indian tribe or tribal organization under its contract or compact with the Indian Health Service under the Indian Self-Determination and Education Assistance Act [25 U.S.C. 5301 et seq.]; (ii) acting within the scope of the employ- ment, contract, or compact described in clause (i); and (iii) who is designated as an Internet Eligi- ble Controlled Substances Provider by the Secretary under section 831(g)(2) of this title; (D)(i) is being conducted during a public health emergency declared by the Secretary under section 247d of title 42; and (ii) involves patients located in such areas, and such controlled substances, as the Sec- retary, with the concurrence of the Attorney General, designates, provided that such des- ignation shall not be subject to the procedures prescribed by subchapter II of chapter 5 of title 5; (E) is being conducted by a practitioner who has obtained from the Attorney General a spe- cial registration under section 831(h) of this title; (F) is being conducted— (i) in a medical emergency situation— (I) that prevents the patient from being in the physical presence of a practitioner registered under section 823(g) of this title who is an employee or contractor of the Veterans Health Administration acting in the usual course of business and employ- ment and within the scope of the official duties or contract of that employee or con- tractor; (II) that prevents the patient from being physically present at a hospital or clinic operated by the Department of Veterans Affairs registered under section 823(g) of this title; (III) during which the primary care prac- titioner of the patient or a practitioner otherwise practicing telemedicine within the meaning of this paragraph is unable to provide care or consultation; and (IV) that requires immediate interven- tion by a health care practitioner using controlled substances to prevent what the practitioner reasonably believes in good faith will be imminent and serious clinical consequences, such as further injury or death; and (ii) by a practitioner that— (I) is an employee or contractor of the Veterans Health Administration acting within the scope of that employment or contract; (II) is registered under section 823(g) of this title in any State or is utilizing the registration of a hospital or clinic oper- ated by the Department of Veterans Af- fairs registered under section 823(g) of this title; and (III) issues a controlled substance pre- scription in this emergency context that is limited to a maximum of a 5-day supply which may not be extended or refilled; or (G) is being conducted under any other cir- cumstances that the Attorney General and the Secretary have jointly, by regulation, deter- mined to be consistent with effective controls against diversion and otherwise consistent with the public health and safety. (55) The term ‘‘refilling prescriptions for con- trolled substances in schedule III, IV, or V’’— Page 790 TITLE 21—FOOD AND DRUGS § 802 (A) means the dispensing of a controlled sub- stance in schedule III, IV, or V in accordance with refill instructions issued by a practi- tioner as part of a valid prescription that meets the requirements of subsections (b) and (c) of section 829 of this title, as appropriate; and (B) does not include the issuance of a new prescription to an individual for a controlled substance that individual was previously pre- scribed. (56) The term ‘‘filling new prescriptions for controlled substances in schedule III, IV, or V’’ means filling a prescription for an individual for a controlled substance in schedule III, IV, or V, if— (A) the pharmacy dispensing that prescrip- tion has previously dispensed to the patient a controlled substance other than by means of the Internet and pursuant to the valid pre- scription of a practitioner that meets the ap- plicable requirements of subsections (b) and (c) of section 829 of this title (in this para- graph referred to as the ‘‘original prescrip- tion’’); (B) the pharmacy contacts the practitioner who issued the original prescription at the re- quest 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 subpara- graph (A); and (C) the practitioner, acting in the usual course of professional practice, determines there is a legitimate medical purpose for the issuance of the new prescription. (57) The term ‘‘suspicious order’’ may include, but is not limited to— (A) an order of a controlled substance of un- usual size; (B) an order of a controlled substance devi- ating substantially from a normal pattern; and (C) orders of controlled substances of un- usual frequency. (58) The term ‘‘serious drug felony’’ means an offense described in section 924(e)(2) of title 18 for which— (A) the offender served a term of imprison- ment of more than 12 months; and (B) the offender’s release from any term of imprisonment was within 15 years of the com- mencement of the instant offense. (59) The term ‘‘serious violent felony’’ means— (A) an offense described in section 3559(c)(2) of title 18 for which the offender served a term of imprisonment of more than 12 months; and (B) any offense that would be a felony viola- tion of section 113 of title 18, if the offense were committed in the special maritime and territorial jurisdiction of the United States, for which the offender served a term of impris- onment of more than 12 months. (Pub. L. 91–513, title II, § 102, Oct. 27, 1970, 84 Stat. 1242; Pub. L. 93–281, § 2, May 14, 1974, 88 Stat. 124; Pub. L. 95–633, title I, § 102(b), Nov. 10, 1978, 92 Stat. 3772; Pub. L. 96–132, § 16(a), Nov. 30, 1979, 93 Stat. 1049; Pub. L. 98–473, title II, § 507(a), (b), Oct. 12, 1984, 98 Stat. 2071; Pub. L. 98–509, title III, § 301(a), Oct. 19, 1984, 98 Stat. 2364; Pub. L. 99–514, § 2, Oct. 22, 1986, 100 Stat. 2095; Pub. L. 99–570, title I, §§ 1003(b), 1203, 1870, Oct. 27, 1986, 100 Stat. 3207–6, 3207–13, 3207–56; Pub. L. 99–646, § 83, Nov. 10, 1986, 100 Stat. 3619; Pub. L. 100–690, title VI, § 6054, Nov. 18, 1988, 102 Stat. 4316; Pub. L. 101–647, title XIX, § 1902(b), title XXIII, § 2301, title XXXV, § 3599I, Nov. 29, 1990, 104 Stat. 4852, 4858, 4932; Pub. L. 103–200, §§ 2(a), 7–9(a), Dec. 17, 1993, 107 Stat. 2333, 2340; Pub. L. 103–322, title IX, § 90105(d), title XXXIII, § 330024(a), (b), (d)(1), Sept. 13, 1994, 108 Stat. 1988, 2150; Pub. L. 104–237, title II, §§ 204(a), 209, title IV, § 401(a), (b), Oct. 3, 1996, 110 Stat. 3102, 3104, 3106, 3107; Pub. L. 104–294, title VI, §§ 604(b)(4), 607(j), Oct. 11, 1996, 110 Stat. 3506, 3512; Pub. L. 105–115, title I, § 126(c)(3), Nov. 21, 1997, 111 Stat. 2328; Pub. L. 106–172, §§ 3(c), 5(a), Feb. 18, 2000, 114 Stat. 9, 10; Pub. L. 106–310, div. B, title XXXVI, § 3622(a), Oct. 17, 2000, 114 Stat. 1231; Pub. L. 107–273, div. B, title IV, § 4002(c)(1), Nov. 2, 2002, 116 Stat. 1808; Pub. L. 108–358, § 2(a), Oct. 22, 2004, 118 Stat. 1661; Pub. L. 109–162, title XI, § 1180, Jan. 5, 2006, 119 Stat. 3126; Pub. L. 109–177, title VII, §§ 711(a)(1), (2)(A), 712(a)(1), Mar. 9, 2006, 120 Stat. 256, 257, 263; Pub. L. 110–425, § 3(a), Oct. 15, 2008, 122 Stat. 4821; Pub. L. 113–260, § 2(a), Dec. 18, 2014, 128 Stat. 2929; Pub. L. 114–198, title III, § 303(a)(2), July 22, 2016, 130 Stat. 722; Pub. L. 115–271, title III, §§ 3202(c), 3292(a), Oct. 24, 2018, 132 Stat. 3945, 3956; Pub. L. 115–334, title XII, § 12619(a), Dec. 20, 2018, 132 Stat. 5018; Pub. L. 115–391, title IV, § 401(a)(1), Dec. 21, 2018, 132 Stat. 5220; Pub. L. 117–215, § 2(b), title I, § 103(b)(1)(A), Dec. 2, 2022, 136 Stat. 2258, 2262; Pub. L. 118–189, § 1, Dec. 23, 2024, 138 Stat. 2652.) Editorial Notes REFERENCES IN TEXT Schedules I, II, III, IV, and V, referred to in pars. (6), (14), (32)(A), (52)(B)(viii), (55), and (56), are set out in section 812(c) of this title. This subchapter, referred to in introductory provi- sions 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 com- plete 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 classifica- tion 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 classi- fied 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 sec- tion 801 of this title and Tables. The Indian Self-Determination and Education Assist- ance 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 classi- fied 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. Page 791 TITLE 21—FOOD AND DRUGS § 802 AMENDMENTS 2024—Pars. (57) to (59). Pub. L. 118–189 redesignated pars. (57) defining the term ‘‘serious drug felony’’ and (58) as (58) and (59), respectively, and realigned margins. 2022—Par. (16)(A). Pub. L. 117–215, § 2(b)(1), substituted ‘‘the terms ‘marihuana’ and ‘marijuana’ mean’’ for ‘‘the term ‘marihuana’ means’’. Par. (16)(B). Pub. L. 117–215, § 2(b)(2), substituted ‘‘The terms ‘marihuana’ and ‘marijuana’ do not’’ for ‘‘The term ‘marihuana’ does not’’ in introductory provisions. Par. (52)(B). Pub. L. 117–215, § 103(b)(1)(A)(i)(I), sub- stituted ‘‘823(g)’’ for ‘‘823(f)’’ wherever appearing. Par. (52)(B)(i). Pub. L. 117–215, § 103(b)(1)(A)(i)(II), sub- stituted ‘‘(e), or (f)’’ for ‘‘(d), or (e)’’. Par. (54). Pub. L. 117–215, § 103(b)(1)(A)(ii), substituted ‘‘823(g)’’ for ‘‘823(f)’’ wherever appearing. 2018—Par. (16). Pub. L. 115–334 designated first sen- tence as subpar. (A), substituted ‘‘Subject to subpara- graph (B), the’’ for ‘‘The’’, inserted subpar. (B) designa- tion, introductory provisions, and cl. (i), designated second sentence as cl. (ii) of subpar. (B), and sub- stituted ‘‘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 Wel- fare’’. Par. (57). Pub. L. 115–391, § 401(a)(1), added par. (57) de- fining the term ‘‘serious drug felony’’. Pub. L. 115–271, § 3292(a), added par. (57) defining the term ‘‘suspicious order’’. Par. (58). Pub. L. 115–391, § 401(a)(1), added par. (58). 2016—Par. (18). Pub. L. 114–198 inserted ‘‘or ‘opioid’ ’’ after ‘‘The term ‘opiate’ ’’. 2014—Par. (41)(A)(l) to (lxxv). Pub. L. 113–260, § 2(a)(1), added cls. (l) to (lxxiv) and redesignated former cl. (xlx) as (lxxv). Par. (41)(C). Pub. L. 113–260, § 2(a)(2), added subpar. (C). 2008—Pars. (50) to (56). Pub. L. 110–425 added pars. (50) to (56). 2006—Par. (39)(A)(iv). Pub. L. 109–177, § 712(a)(1)(A)(i), amended cl. (iv) generally. Prior to amendment, cl. (iv) related to transactions involving drugs containing ephedrine, pseudoephedrine, or phenylpropanolamine. Par. (39)(A)(v), (vi). Pub. L. 109–177, § 712(a)(1)(A)(ii), (iii), added cl. (v) and redesignated former cl. (v) as (vi). Par. (41)(A)(xvii). Pub. L. 109–162, § 1180(1), substituted ‘‘13β-ethyl-17β-hydroxygon-4-en-3-one;’’ for ‘‘13β-ethyl- 17α-hydroxygon-4-en-3-one;’’. Par. (41)(A)(xliv). Pub. L. 109–162, § 1180(2), substituted ‘‘(17α-methyl-17β-hydroxy-[5α]-androst-2-eno[3,2-c]-pyr- azole);’’ 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 de- fined ‘‘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), redesig- nated par. (46) as (49), substituted ‘‘ephedrine, pseudoephedrine, or’’ for ‘‘pseudoephedrine or’’ in sub- par. (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 sub- par. (A) which defined ‘‘anabolic steroid’’. Par. (44). Pub. L. 108–358, § 2(a)(2), inserted ‘‘anabolic steroids,’’ after ‘‘marihuana,’’. 2002—Pars. (43), (44). Pub. L. 107–273 repealed Pub. L. 104–294, §§ 604(b)(4), 607(j)(2). See 1996 Amendment note below. 2000—Par. (32)(A). Pub. L. 106–172, § 5(a)(1), substituted ‘‘subparagraph (C)’’ for ‘‘subparagraph (B)’’ in introduc- tory 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 be- fore 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 des- ignated by the Secretary as habit forming under sec- tion 352(d) of this title; or’’. 1996—Par. (26). Pub. L. 104–294, § 607(j)(1), amended par. (26) generally. Prior to amendment, par. (26) read as follows: ‘‘The term ‘State’ means any State, terri- tory, or possession of the United States, the District of Columbia, the Commonwealth of Puerto Rico, the Trust Territory of the Pacific Islands, and the Canal Zone.’’ Par. (34)(P), (S), (U). Pub. L. 104–237, § 209(1), sub- stituted ‘‘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)’’ be- fore period at end. Par. (35)(I), (J). Pub. L. 104–237, § 204(a), added subpars. (I) and (J). Par. (39)(A)(iv)(I)(aa). Pub. L. 104–237, § 401(a)(1), (b)(1), substituted ‘‘, pseudoephedrine or its salts, optical iso- mers, or salts of optical isomers, or phenylpropanola- mine 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 prod- ucts by retail distributors shall not be a regulated transaction (except as provided in section 401(d) of the Comprehensive Methamphetamine Control Act of 1996);’’ for ‘‘as the only active medicinal ingredient or contains ephedrine or its salts, optical isomers, or salts of optical isomers and therapeutically insignificant quantities of another active medicinal ingredient;’’. Par. (39)(A)(iv)(II). Pub. L. 104–237, § 401(a)(2), (b)(2), inserted ‘‘, pseudoephedrine, phenylpropanolamine,’’ after ‘‘ephedrine’’ and inserted before semicolon ‘‘, except that the threshold for any sale of products containing pseudoephedrine or phenylpropanolamine products by retail distributors or by distributors re- quired to submit reports by section 830(b)(3) of this title shall be 24 grams of pseudoephedrine or 24 grams of phenylpropanolamine in a single transaction’’. Pars. (43), (44). Pub. L. 104–294, §§ 604(b)(4), 607(j)(2), which provided for amendment to section identical to Pub. L. 104–237, § 401(b)(3), below, were repealed by Pub. L. 107–273, § 4002(c)(1). Pub. L. 104–237, § 401(b)(3), redesignated par. (43), re- lating to felony drug offense, as (44). Pars. (45), (46). Pub. L. 104–237, § 401(b)(4), added pars. (45) and (46). 1994—Par. (34)(V), (W). Pub. L. 103–322, § 330024(b), re- aligned 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), sub- stituted ‘‘; or’’ for period at end. Par. (43). Pub. L. 103–322, § 90105(d), added par. (43) de- fining ‘‘felony drug offense’’. 1993—Par. (33). Pub. L. 103–200, § 2(a)(1), substituted ‘‘any list I chemical or any list II chemical’’ for ‘‘any listed precursor chemical or listed essential chemical’’. Par. (34). Pub. L. 103–200, § 2(a)(2), substituted ‘‘list I chemical’’ for ‘‘listed precursor chemical’’ and ‘‘impor- tant to the manufacture’’ for ‘‘critical to the creation’’ in introductory provisions. Par. (34)(A), (F), (H). Pub. L. 103–200, § 2(a)(3), inserted ‘‘, its esters,’’ before ‘‘and’’. Par. (34)(O). Pub. L. 103–200, § 8(1), (2), redesignated subpar. (P) as (O) and struck out former subpar. (O) which read as follows: ‘‘D-lysergic acid.’’ Page 792 TITLE 21—FOOD AND DRUGS § 802 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 sub- par. (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 sub- par. (Y) as (X). Par. (35). Pub. L. 103–200, § 2(a)(4)(A), (C), substituted ‘‘list II chemical’’ for ‘‘listed essential chemical’’ and struck out ‘‘as a solvent, reagent, or catalyst’’ before ‘‘in manufacturing’’. Pub. L. 103–200, § 2(a)(4)(B), as amended by Pub. L. 103–322, § 330024(d)(1), inserted ‘‘(other than a list I chemical)’’ before ‘‘specified’’ the first time appearing. Par. (37). Pub. L. 103–200, § 9(a), amended par. (37) gen- erally. Prior to amendment, par. (37) read as follows: ‘‘The term ‘regular supplier’ means, with respect to a regulated person, a supplier with whom the regulated person has an established business relationship that is reported to the Attorney General.’’ Par. (38). Pub. L. 103–200, § 2(a)(5), inserted before pe- riod at end ‘‘or who acts as a broker or trader for an international transaction involving a listed chemical, a tableting machine, or an encapsulating machine’’. Par. (39)(A). Pub. L. 103–200, §§ 2(a)(6)(A), 7, in intro- ductory provisions, substituted ‘‘importation, or expor- tation of, or an international transaction involving shipment of,’’ for ‘‘importation or exportation of’’ and inserted ‘‘a listed chemical, or if the Attorney General establishes a threshold amount for a specific listed chemical,’’ before ‘‘a threshold amount,’’. Par. (39)(A)(iii). Pub. L. 103–200, § 2(a)(6)(B), inserted ‘‘or any category of transaction for a specific listed chemical or chemicals’’ after ‘‘transaction’’. Par. (39)(A)(iv). Pub. L. 103–200, § 2(a)(6)(C), amended cl. (iv) generally. Prior to amendment, cl. (iv) read as follows: ‘‘any transaction in a listed chemical that is contained in a drug that may be marketed or distrib- uted lawfully in the United States under the Federal Food, Drug, and Cosmetic Act; or’’. Par. (39)(A)(v). Pub. L. 103–200, § 2(a)(6)(D), inserted before semicolon at end ‘‘which the Attorney General has by regulation designated as exempt from the appli- cation of this subchapter and subchapter II based on a finding that the mixture is formulated in such a way that it cannot be easily used in the illicit production of a controlled substance and that the listed chemical or chemicals contained in the mixture cannot be readily recovered’’. Par. (40). Pub. L. 103–200, § 2(a)(7), substituted ‘‘list I chemical or a list II chemical’’ for ‘‘listed precursor chemical or a listed essential chemical’’ in two places. Pars. (42), (43). Pub. L. 103–200, § 2(a)(8), added pars. (42) and (43). 1990—Par. (32)(A). Pub. L. 101–647, § 3599I, substituted ‘‘the stimulant’’ for ‘‘the stimulent’’ in cl. (ii) and ‘‘a stimulant’’ for ‘‘a stimulent’’ in cl. (iii). Par. (34)(M) to (Y). Pub. L. 101–647, § 2301(a), added subpars. (M) to (Y). Par. (35)(E). Pub. L. 101–647, § 2301(b), struck out sub- par. (E) ‘‘Hydriodic acid.’’ Par. (41). Pub. L. 101–647, § 1902(b), added par. (41). 1988—Par. (8). Pub. L. 100–690, § 6054(1), inserted ‘‘or a listed chemical’’ after ‘‘a controlled substance’’. Par. (11). Pub. L. 100–690, § 6054(2), inserted ‘‘or a listed chemical’’ after ‘‘a controlled substance’’ in two places. Pars. (33) to (40). Pub. L. 100–690, § 6054(3), added pars. (33) to (40). 1986—Par. (6). Pub. L. 99–514 substituted ‘‘Internal Revenue Code of 1986’’ for ‘‘Internal Revenue Code of 1954’’. Par. (14). Pub. L. 99–570, § 1870, and Pub. L. 99–646 amended par. (14) identically, substituting ‘‘any opti- cal’’ 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), redesig- nated pars. (25) to (30) as (26) to (31), respectively. Par. (32). Pub. L. 99–570, § 1203, added par. (32). 1984—Pars. (14) to (16). Pub. L. 98–473, § 507(a), added par. (14) and redesignated former pars. (14) to (16) as (15) to (17), respectively. Par. (17). Pub. L. 98–473, § 507, redesignated former par. (16) as (17), and expanded and revised definition of ‘‘narcotic drug’’, including within term poppy straw, cocaine, and ecgonine. Former par. (17) redesignated (18). Pars. (18) to (28). Pub. L. 98–473, § 507(a), redesignated former pars. (17) to (27) as (18) to (28), respectively. Par. (29). Pub. L. 98–509 which directed the substi- tution of ‘‘one hundred and eighty’’ for ‘‘twenty-one’’ in par. (28), was executed to par. (29) in view of the re- designation 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 pro- visions defining ‘‘Bureau of Narcotics and Dangerous Drugs’’. 1978—Par. (29). Pub. L. 95–633 added par. (29). 1974—Pars. (27), (28). Pub. L. 93–281 added pars. (27) and (28). Statutory Notes and Related Subsidiaries EFFECTIVE DATE OF 2018 AMENDMENT Pub. L. 115–391, title IV, § 401(c), Dec. 21, 2018, 132 Stat. 5221, provided that: ‘‘This section [amending this sec- tion 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 enact- ment of this Act [Dec. 21, 2018], if a sentence for the of- fense has not been imposed as of such date of enact- ment.’’ EFFECTIVE DATE OF 2008 AMENDMENT Pub. L. 110–425, § 3(j), Oct. 15, 2008, 122 Stat. 4832, pro- vided that: ‘‘(1) IN GENERAL.—Except as provided in paragraph (2), the amendments made by this Act [enacting section 831 of this title and amending this section and sections 823, 827, 829, 841, 843, 882 and 960 of this title] shall take ef- fect 180 days after the date of enactment of this Act [Oct. 15, 2008]. ‘‘(2) DEFINITION OF PRACTICE OF TELEMEDICINE.— ‘‘(A) IN GENERAL.—Until the earlier of 3 months after the date on which regulations are promulgated to carry out section 311(h) of the Controlled Sub- stances Act [21 U.S.C. 831(h)], as amended by this Act, or 15 months after the date of enactment of this Act— ‘‘(i) the definition of the term ‘practice of tele- medicine’ in subparagraph (B) of this paragraph shall apply for purposes of the Controlled Sub- stances Act [21 U.S.C. 801 et seq.]; and ‘‘(ii) the definition of the term ‘practice of tele- medicine’ in section 102(54) of the Controlled Sub- stances Act [21 U.S.C. 802(54)], as amended by this Act, shall not apply. ‘‘(B) TEMPORARY PHASE-IN OF TELEMEDICINE REGULA- TION.—During the period specified in subparagraph (A), the term ‘practice of telemedicine’ means the practice of medicine in accordance with applicable Federal and State laws by a practitioner (as that term is defined in section 102 of the Controlled Sub- stances 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 pro- fessional who is treating the patient, using a tele- Page 793 TITLE 21—FOOD AND DRUGS § 802 communications system referred to in section 1834(m) of the Social Security Act (42 U.S.C. 1395m(m)), if the practitioner is using an interactive telecommuni- cations system that satisfies the requirements of sec- tion 410.78(a)(3) of title 42, Code of Federal Regula- tions. ‘‘(C) RULE OF CONSTRUCTION.—Nothing in this sub- section may be construed to create a precedent that any specific course of conduct constitutes the ‘prac- tice of telemedicine’ (as that term is defined in sec- tion 102(54) of the Controlled Substances Act, as amended by this Act) after the end of the period spec- ified in subparagraph (A).’’ EFFECTIVE DATE OF 2004 AMENDMENT Pub. L. 108–358, § 2(d), Oct. 22, 2004, 118 Stat. 1664, pro- vided that: ‘‘The amendments made by this section [amending this section, section 811 of this title, and provisions set out as a note under this section] shall take effect 90 days after the date of enactment of this Act [Oct. 22, 2004].’’ EFFECTIVE DATE OF 2002 AMENDMENT Pub. L. 107–273, div. B, title IV, § 4002(c)(1), Nov. 2, 2002, 116 Stat. 1808, provided that the amendment made by section 4002(c)(1) is effective Oct. 11, 1996. EFFECTIVE DATE OF 2000 AMENDMENT Pub. L. 106–310, div. B, title XXXVI, § 3622(b), Oct. 17, 2000, 114 Stat. 1231, provided that: ‘‘The amendments made by subsection (a) [amending this section] shall take effect 1 year after the date of the enactment of this Act [Oct. 17, 2000].’’ EFFECTIVE DATE OF 1997 AMENDMENT Amendment by Pub. L. 105–115 effective 90 days after Nov. 21, 1997, except as otherwise provided, see section 501 of Pub. L. 105–115, set out as a note under section 321 of this title. EFFECTIVE DATE OF 1996 AMENDMENTS Amendment by section 604(b)(4) of Pub. L. 104–294 ef- fective Sept. 13, 1994, see section 604(d) of Pub. L. 104–294, set out as a note under section 13 of Title 18, Crimes and Criminal Procedure. Pub. L. 104–237, title IV, § 401(g), Oct. 3, 1996, 110 Stat. 3110, provided that: ‘‘Notwithstanding any other provi- sion 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 provi- sions 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 Gen- eral may, in her sole discretion, extend such effective date up to an additional six months. Notwithstanding any other provision of law, the decision of the Attorney General on such an application shall not be subject to judicial review.’’ EFFECTIVE DATE OF 1994 AMENDMENT Pub. L. 103–322, title XXXIII, § 330024(f), Sept. 13, 1994, 108 Stat. 2151, provided that: ‘‘The amendments made by this section [amending this section and sections 824, 960, and 971 of this title] shall take effect as of the date that is 120 days after the date of enactment of the Do- mestic Chemical Diversion Control Act of 1993 [Dec. 17, 1993].’’ EFFECTIVE DATE OF 1993 AMENDMENT Pub. L. 103–200, § 11, Dec. 17, 1993, 107 Stat. 2341, pro- vided 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 pro- visions set out as a note under section 801 of this title] and the amendments made by this Act shall take effect on the date that is 120 days after the date of enactment of this Act [Dec. 17, 1993].’’ EFFECTIVE DATE OF 1990 AMENDMENT Pub. L. 101–647, title XIX, § 1902(d), Nov. 29, 1990, 104 Stat. 4852, provided that: ‘‘This section [amending this section and section 812 of this title and enacting provi- sions set out as a note under section 829 of this title] and the amendment made by this section shall take ef- fect 90 days after the date of enactment of this Act [Nov. 29, 1990].’’ EFFECTIVE DATE OF 1988 AMENDMENT Pub. L. 100–690, title VI, § 6061, Nov. 18, 1988, 102 Stat. 4320, provided that: ‘‘Except as otherwise provided in this subtitle, this subtitle [subtitle A (§§ 6051–6061) of title VI of Pub. L. 100–690, enacting section 971 of this title, amending this section and sections 830, 841 to 843, 872, 876, 881, 960, and 961 of this title, and enacting pro- visions set out as notes under this section and section 971 of this title] shall take effect 120 days after the en- actment of this Act [Nov. 18, 1988].’’ EFFECTIVE DATE OF 1978 AMENDMENT Amendment by Pub. L. 95–633 effective on date the Convention on Psychotropic Substances enters into force in the United States [July 15, 1980], see section 112 of Pub. L. 95–633, set out as an Effective Date note under section 801a of this title. REGULATIONS Pub. L. 110–425, § 3(k)(1), Oct. 15, 2008, 122 Stat. 4833, provided that: ‘‘The Attorney General may promulgate and enforce any rules, regulations, and procedures which may be necessary and appropriate for the effi- cient execution of functions under this Act [see Short Title of 2008 Amendment note set out under section 801 of this title] or the amendments made by this Act, and, with the concurrence of the Secretary of Health and Human Services where this Act or the amendments made by this Act so provide, promulgate any interim rules necessary for the implementation of this Act or the amendments made by this Act, prior to its effective date [see Effective Date of 2008 Amendment note above].’’ Pub. L. 98–509, title III, § 301(b), Oct. 19, 1984, 98 Stat. 2364, provided that: ‘‘The Secretary of Health and Human Services shall, within ninety days of the date of the enactment of this Act [Oct. 19, 1984], promulgate regulations for the administration of section 102(28) of the Controlled Substances Act [21 U.S.C. 802(29)] as amended by subsection (a) and shall include in the first report submitted under section 505(b) [503(b)] of the Public Health Service Act [former 42 U.S.C. 290aa–2(b)] after the expiration of such ninety days the findings of the Secretary with respect to the effect of the amend- ment made by subsection (a).’’ CONSTRUCTION OF 2008 AMENDMENT Pub. L. 110–425, § 4, Oct. 15, 2008, 122 Stat. 4834, pro- vided that: ‘‘Nothing in this Act [see Short Title of 2008 Amendment note set out under section 801 of this title] or the amendments made by this Act shall be construed as authorizing, prohibiting, or limiting the use of elec- tronic prescriptions for controlled substances.’’ PRESERVATION OF STATE AUTHORITY TO REGULATE SCHEDULED LISTED CHEMICALS Pub. L. 109–177, title VII, § 711(g), Mar. 9, 2006, 120 Stat. 263, provided that: ‘‘This section [amending this section and sections 830, 841, 842, and 844 of this title and enacting provisions set out as notes under sections 830 and 844 of this title] and the amendments made by this section may not be construed as having any legal effect on section 708 of the Controlled Substances Act [21 U.S.C. 903] as applied to the regulation of scheduled Page 794 TITLE 21—FOOD AND DRUGS § 803 listed chemicals (as defined in section 102(45) of such Act [21 U.S.C. 802(45)]).’’ REPORT ON DIVERSION OF ORDINARY, OVER-THE- COUNTER PSEUDOEPHEDRINE AND PHENYLPROPANOLA- MINE PRODUCTS Pub. L. 106–310, div. B, title XXXVI, § 3642, Oct. 17, 2000, 114 Stat. 1237, provided that: ‘‘(a) STUDY.—The Attorney General shall conduct a study of the use of ordinary, over-the-counter pseudoephedrine and phenylpropanolamine products in the clandestine production of illicit drugs. Sources of data for the study shall include the following: ‘‘(1) Information from Federal, State, and local clandestine laboratory seizures and related investiga- tions 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 phenyl- propanolamine, including information on changes in the pattern, volume, or both, of sales of ordinary, over-the-counter pseudoephedrine and phenyl- propanolamine 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 re- sult of the study; and ‘‘(B) such recommendations on the need to estab- lish additional measures to prevent diversion of or- dinary, over-the-counter pseudoephedrine and phen- ylpropanolamine (such as a threshold on ordinary, over-the-counter pseudoephedrine and phenyl- propanolamine 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 rec- ommendations, 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 Gen- eral 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, phenyl- propanolamine 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 lim- its for retail distributors of either or both of such products. ‘‘(2) DUE PROCESS.—The Attorney General shall es- tablish the single-transaction limit under paragraph (1) only after notice, comment, and an informal hear- ing.’’ 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 combina- tion ephedrine products for retail distributors, was re- pealed by Pub. L. 109–177, title VII, § 712(b), Mar. 9, 2006, 120 Stat. 264. EXEMPTION FOR SUBSTANCES IN PARAGRAPH (41) Pub. L. 101–647, title XIX, § 1903, Nov. 29, 1990, 104 Stat. 4853, as amended by Pub. L. 108–358, § 2(c), Oct. 22, 2004, 118 Stat. 1663, provided that: ‘‘(a) DRUGS FOR TREATMENT OF RARE DISEASES.—If the Attorney General finds that a drug listed in para- graph (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 condi- tion, as defined in section 526 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bb); and ‘‘(2) does not have a significant potential for abuse, the Attorney General may exempt such drug from any production regulations otherwise issued under the Controlled Substances Act as may be necessary to ensure adequate supplies of such drug for medical purposes. ‘‘(b) DATE OF ISSUANCE OF REGULATIONS.—The Attor- ney General shall issue regulations implementing this section not later than 45 days after the date of enact- ment of this Act [Nov. 29, 1990], except that the regula- tions required under section 3(a) [former 1903(a)] shall be issued not later than 180 days after the date of en- actment of this Act.’’ § 803. Repealed. Pub. L. 95–137, § 1(b), Oct. 18, 1977, 91 Stat. 1169 Section, Pub. L. 91–513, title II, § 103, Oct. 27, 1970, 84 Stat. 1245, authorized Bureau of Narcotics and Dan- gerous Drugs to add, during fiscal year 1971, 300 agents, together with necessary supporting personnel, and pro- vided for appropriations of $6,000,000 to carry out such addition. PART B—AUTHORITY TO CONTROL; STANDARDS AND SCHEDULES § 811. Authority and criteria for classification of substances (a) Rules and regulations of Attorney General; hearing The Attorney General shall apply the provi- sions of this subchapter to the controlled sub- stances listed in the schedules established by section 812 of this title and to any other drug or other substance added to such schedules under this subchapter. Except as provided in sub- sections (d) and (e), the Attorney General may by rule— (1) add to such a schedule or transfer be- tween such schedules any drug or other sub- stance if he— (A) finds that such drug or other substance has a potential for abuse, and (B) makes with respect to such drug or other substance the findings prescribed by subsection (b) of section 812 of this title for the schedule in which such drug is to be placed; or (2) remove any drug or other substance from the schedules if he finds that the drug or other substance does not meet the requirements for inclusion in any schedule. Rules of the Attorney General under this sub- section shall be made on the record after oppor- tunity for a hearing pursuant to the rulemaking