Federal · Title 21 — Food and Drugs
21 U.S.C. § 812: Schedules of controlled substances
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There are established five schedules of controlled substances, to be known as schedules I, II, III, IV, and V. Such schedules shall initially consist of the substances listed in this section. The schedules established by this section shall be updated and republished on a semiannual basis during the two-year period beginning one year after October 27, 1970 , and shall be updated and republished on an annual basis thereafter. 1 1 See Amendment of Schedules of Controlled Substances note below. The drug or other substance has a high potential for abuse. The drug or other substance has no currently accepted medical use in treatment in the United States. There is a lack of accepted safety for use of the drug or other substance under medical supervision. The drug or other substance has a high potential for abuse. The drug or other substance has a currently accepted medical use in treatment in the United States or a currently accepted medical use with severe restrictions. Abuse of the drug or other substances may lead to severe psychological or physical dependence. The drug or other substance has a potential for abuse less than the drugs or other substances in schedules I and II. The drug or other substance has a currently accepted medical use in treatment in the United States. Abuse of the drug or other substance may lead to moderate or low physical dependence or high psychological dependence. The drug or other substance has a low potential for abuse relative to the drugs or other substances in schedule III. The drug or other substance has a currently accepted medical use in treatment in the United States. Abuse of the drug or other substance may lead to limited physical dependence or psychological dependence relative to the drugs or other substances in schedule III. The drug or other substance has a low potential for abuse relative to the drugs or other substances in schedule IV. The drug or other substance has a currently accepted medical use in treatment in the United States. Abuse of the drug or other substance may lead to limited physical dependence or psychological dependence relative to the drugs or other substances in schedule IV. Schedules I, II, III, IV, and V shall, unless and until amended pursuant to section 811 of this title , consist of the following drugs or other substances, 1 by whatever official name, common or usual name, chemical name, or brand name designated: Acetylmethadol. Allylprodine. Alphacetylmathadol. 2 2 So in original. Probably should be “Alphacetylmethadol.” Alphameprodine. Alphamethadol. Benzethidine. Betacetylmethadol. Betameprodine. Betamethadol. Betaprodine. Clonitazene. Dextromoramide. Dextrorphan. Diampromide. Diethylthiambutene. Dimenoxadol. Dimepheptanol. Dimethylthiambutene. Dioxaphetyl butyrate. Dipipanone. Ethylmethylthiambutene. Etonitazene. Etoxeridine. Furethidine. Hydroxypethidine. Ketobemidone. Levomoramide. Levophenacylmorphan. Morpheridine. Noracymethadol. Norlevorphanol. Normethadone. Norpipanone. Phenadoxone. Phenampromide. Phenomorphan. Phenoperidine. Piritramide. Proheptazine. Properidine. Racemoramide. Trimeperidine. Acetorphine. Acetyldihydrocodeine. Benzylmorphine. Codeine methylbromide. Codeine-N-Oxide. Cyprenorphine. Desomorphine. Dihydromorphine. Etorphine. Heroin. Hydromorphinol. Methyldesorphine. Methylhydromorphine. Morphine methylbromide. Morphine methylsulfonate. Morphine-N-Oxide. Myrophine. Nicocodeine. Nicomorphine. Normorphine. Pholcodine. Thebacon. 3,4-methylenedioxy amphetamine. 5-methoxy-3,4-methylenedioxy amphetamine. 3,4,5-trimethoxy amphetamine. Bufotenine. Diethyltryptamine. Dimethyltryptamine. 4-methyl-2,5-dimethoxyamphetamine. Ibogaine. Lysergic acid diethylamide. Marihuana. Mescaline. Peyote. N-ethyl-3-piperidyl benzilate. N-methyl-3-piperidyl benzilate. Psilocybin. Psilocyn. Tetrahydrocannabinols, except for tetrahydrocannabinols in hemp (as defined under section 1639 o of title 7). 4-methylmethcathinone (Mephedrone). 3,4-methylenedioxypyrovalerone (MDPV). 2-(2,5-Dimethoxy-4-ethylphenyl)ethanamine (2C–E). 2-(2,5-Dimethoxy-4-methylphenyl)ethanamine (2C–D). 2-(4-Chloro-2,5-dimethoxyphenyl)ethanamine (2C–C). 2-(4-Iodo-2,5-dimethoxyphenyl)ethanamine (2C–I). 2-[4-(Ethylthio)-2,5-dimethoxyphenyl]ethanamine (2C–T–2). 2-[4-(Isopropylthio)-2,5-dimethoxyphenyl]ethanamine (2C–T–4). 2-(2,5-Dimethoxyphenyl)ethanamine (2C–H). 2-(2,5-Dimethoxy-4-nitro-phenyl)ethanamine (2C–N). 2-(2,5-Dimethoxy-4-(n)-propylphenyl)ethanamine (2C–P). Unless specifically exempted or unless listed in another schedule, any material, compound, mixture, or preparation which contains any quantity of cannabimimetic agents, or which contains their salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible within the specific chemical designation. 2-(3-hydroxycyclohexyl)phenol with substitution at the 5-position of the phenolic ring by alkyl or alkenyl, whether or not substituted on the cyclohexyl ring to any extent. 3-(1-naphthoyl)indole or 3-(1-naphthylmethane)indole by substitution at the nitrogen atom of the indole ring, whether or not further substituted on the indole ring to any extent, whether or not substituted on the naphthoyl or naphthyl ring to any extent. 3-(1-naphthoyl)pyrrole by substitution at the nitrogen atom of the pyrrole ring, whether or not further substituted in the pyrrole ring to any extent, whether or not substituted on the naphthoyl ring to any extent. 1-(1-naphthylmethylene)indene by substitution of the 3-position of the indene ring, whether or not further substituted in the indene ring to any extent, whether or not substituted on the naphthyl ring to any extent. 3-phenylacetylindole or 3-benzoylindole by substitution at the nitrogen atom of the indole ring, whether or not further substituted in the indole ring to any extent, whether or not substituted on the phenyl ring to any extent. 5-(1,1-dimethylheptyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-phenol (CP–47,497); 5-(1,1-dimethyloctyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-phenol (cannabicyclohexanol or CP–47,497 C8-homolog); 1-pentyl-3-(1-naphthoyl)indole (JWH–018 and AM678); 1-butyl-3-(1-naphthoyl)indole (JWH–073); 1-hexyl-3-(1-naphthoyl)indole (JWH–019); 1-[2-(4-morpholinyl)ethyl]-3-(1-naphthoyl)indole (JWH–200); 1-pentyl-3-(2-methoxyphenylacetyl)indole (JWH–250); 1-pentyl-3-[1-(4-methoxynaphthoyl)]indole (JWH–081); 1-pentyl-3-(4-methyl-1-naphthoyl)indole (JWH–122); 1-pentyl-3-(4-chloro-1-naphthoyl)indole (JWH–398); 1-(5-fluoropentyl)-3-(1-naphthoyl)indole (AM2201); 1-(5-fluoropentyl)-3-(2-iodobenzoyl)indole (AM694); 1-pentyl-3-[(4-methoxy)-benzoyl]indole (SR–19 and RCS–4); 1-cyclohexylethyl-3-(2-methoxyphenylacetyl)indole (SR–18 and RCS–8); and 1-pentyl-3-(2-chlorophenylacetyl)indole (JWH–203). Unless specifically exempted or unless listed in another schedule, any material, compound, mixture, or preparation which contains any quantity of a fentanyl-related substance, or which contains the salts, isomers, and salts of isomers of a fentanyl-related substance whenever the existence of such salts, isomers, and salts of isomers is possible within the specific chemical designation. By replacement of the phenyl portion of the phenethyl group by any monocycle, whether or not further substituted in or on the monocycle. By substitution in or on the phenethyl group with alkyl, alkenyl, alkoxyl, hydroxyl, halo, haloalkyl, amino, or nitro groups. By substitution in or on the piperidine ring with alkyl, alkenyl, alkoxyl, ester, ether, hydroxyl, halo, haloalkyl, amino, or nitro groups. By replacement of the aniline ring with any aromatic monocycle whether or not further substituted in or on the aromatic monocycle. By replacement of the N-propionyl group with another acyl group. is controlled by action of the Attorney General under section 811 of this title ; or is otherwise expressly listed in a schedule other than this schedule. The Attorney General may by order publish in the Federal Register a list of substances that satisfy the definition of the term “fentanyl-related substance” in paragraph (2). The absence of a substance from a list published under subparagraph (A) does not negate the control status of the substance under this schedule if the substance satisfies the definition of the term “fentanyl-related substance” in paragraph (2). Opium and opiate, and any salt, compound, derivative, or preparation of opium or opiate. Any salt, compound, derivative, or preparation thereof which is chemically equivalent or identical with any of the substances referred to in clause (1), except that these substances shall not include the isoquinoline alkaloids of opium. Opium poppy and poppy straw. coca 3 leaves, except coca leaves and extracts of coca leaves from which cocaine, ecgonine, and derivatives of ecgonine or their salts have been removed; cocaine, its salts, optical and geometric isomers, and salts of isomers; ecgonine, its derivatives, their salts, isomers, and salts of isomers; or any compound, mixture, or preparation which contains any quantity of any of the substances referred to in this paragraph. 3 So in original. Probably should be capitalized. Alphaprodine. Anileridine. Bezitramide. Dihydrocodeine. Diphenoxylate. Fentanyl. Isomethadone. Levomethorphan. Levorphanol. Metazocine. Methadone. Methadone-Intermediate, 4-cyano-2-dimethylamino-4,4-diphenyl butane. Moramide-Intermediate, 2-methyl-3-morpholino-1, 1-diphenylpropane-carboxylic acid. Pethidine. Pethidine-Intermediate-A, 4-cyano-1-methyl-4-phenylpiperidine. Pethidine-Intermediate-B, ethyl-4-phenylpiperidine-4-carboxylate. Pethidine-Intermediate-C, 1-methyl-4-phenylpiperidine-4-carboxylic acid. Phenazocine. Piminodine. Racemethorphan. Racemorphan. Unless specifically excepted or unless listed in another schedule, any injectable liquid which contains any quantity of methamphetamine, including its salts, isomers, and salts of isomers. Amphetamine, its salts, optical isomers, and salts of its optical isomers. Phenmetrazine and its salts. Any substance (except an injectable liquid) which contains any quantity of methamphetamine, including its salts, isomers, and salts of isomers. Methylphenidate. Any substance which contains any quantity of a derivative of barbituric acid, or any salt of a derivative of barbituric acid. Chorhexadol. 4 4 So in original. Probably should be “Chlorhexadol.” Glutethimide. Lysergic acid. Lysergic acid amide. Methyprylon. Phencyclidine. Sulfondiethylmethane. Sulfonethylmethane. Sulfonmethane. Nalorphine. Not more than 1.8 grams of codeine per 100 milliliters or not more than 90 milligrams per dosage unit, with an equal or greater quantity of an isoquinoline alkaloid of opium. Not more than 1.8 grams of codeine per 100 milliliters or not more than 90 milligrams per dosage unit, with one or more active, non-narcotic ingredients in recognized therapeutic amounts. Not more than 300 milligrams of dihydrocodeinone per 100 milliliters or not more than 15 milligrams per dosage unit, with a fourfold or greater quantity of an isoquinoline alkaloid of opium. Not more than 300 milligrams of dihydrocodeinone per 100 milliliters or not more than 15 milligrams per dosage unit, with one or more active, nonnarcotic ingredients in recognized therapeutic amounts. Not more than 1.8 grams of dihydrocodeine per 100 milliliters or not more than 90 milligrams per dosage unit, with one or more active, nonnarcotic ingredients in recognized therapeutic amounts. Not more than 300 milligrams of ethylmorphine per 100 milliliters or not more than 15 milligrams per dosage unit, with one or more active, nonnarcotic ingredients in recognized therapeutic amounts. Not more than 500 milligrams of opium per 100 milliliters or per 100 grams, or not more than 25 milligrams per dosage unit, with one or more active, nonnarcotic ingredients in recognized therapeutic amounts. Not more than 50 milligrams of morphine per 100 milliliters or per 100 grams with one or more active, nonnarcotic ingredients in recognized therapeutic amounts. Barbital. Chloral betaine. Chloral hydrate. Ethchlorvynol. Ethinamate. Methohexital. Meprobamate. Methylphenobarbital. Paraldehyde. Petrichloral. Phenobarbital. Not more than 200 milligrams of codeine per 100 milliliters or per 100 grams. Not more than 100 milligrams of dihydrocodeine per 100 milliliters or per 100 grams. Not more than 100 milligrams of ethylmorphine per 100 milliliters or per 100 grams. Not more than 2.5 milligrams of diphenoxylate and not less than 25 micrograms of atropine sulfate per dosage unit. Not more than 100 milligrams of opium per 100 milliliters or per 100 grams. shall, not later than 6 months after the date of enactment of this Act [ July 16, 2025 ], issue rules to implement this Act [see Short Title of 2025 Amendment note set out under section 801 of this title ] and the amendments made by this Act; and may issue the rules under paragraph (1) as interim final rules. A rule issued by the Attorney General as an interim final rule under subsection (a) shall become immediately effective as an interim final rule without requiring the Attorney General to demonstrate good cause therefor, notwithstanding subparagraph (B) of the undesignated matter following paragraph (4) of section 553(b) of title 5 , United States Code. An interim final rule issued under subsection (a) shall give interested persons the opportunity to comment and to request a hearing. After the conclusion of such proceedings, the Attorney General shall issue a final rule to implement this Act and the amendments made by this Act in accordance with section 553 of title 5 , United States Code.” review the relevant data pertaining to the scheduling of products containing a combination of buprenorphine and naloxone that have been approved under section 505 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355 ); and if appropriate, request that the Attorney General initiate rulemaking proceedings to revise the schedules accordingly with respect to such products. The Attorney General shall review any request made by the Secretary of Health and Human Services under subsection (a)(2) and determine whether to initiate proceedings to revise the schedules in accordance with the criteria set forth in sections 201 and 202 of the Controlled Substances Act ( 21 U.S.C. 811 , 812).” Gamma hydroxybutyric acid (also called G, Liquid X, Liquid Ecstasy, Grievous Bodily Harm, Georgia Home Boy, Scoop) has become a significant and growing problem in law enforcement. At least 20 States have scheduled such drug in their drug laws and law enforcement officials have been experiencing an increased presence of the drug in driving under the influence, sexual assault, and overdose cases especially at night clubs and parties. A behavioral depressant and a hypnotic, gamma hydroxybutyric acid (‘GHB’) is being used in conjunction with alcohol and other drugs with detrimental effects in an increasing number of cases. It is difficult to isolate the impact of such drug’s ingestion since it is so typically taken with an ever-changing array of other drugs and especially alcohol which potentiates its impact. GHB takes the same path as alcohol, processes via alcohol dehydrogenase, and its symptoms at high levels of intake and as impact builds are comparable to alcohol ingestion/intoxication. Thus, aggression and violence can be expected in some individuals who use such drug. If taken for human consumption, common industrial chemicals such as gamma butyrolactone and 1.4-butanediol are swiftly converted by the body into GHB. Illicit use of these and other GHB analogues and precursor chemicals is a significant and growing law enforcement problem. A human pharmaceutical formulation of gamma hydroxybutyric acid is being developed as a treatment for cataplexy, a serious and debilitating disease. Cataplexy, which causes sudden and total loss of muscle control, affects about 65 percent of the estimated 180,000 Americans with narcolepsy, a sleep disorder. People with cataplexy often are unable to work, drive a car, hold their children or live a normal life. Abuse of illicit GHB is an imminent hazard to public safety that requires immediate regulatory action under the Controlled Substances Act ( 21 U.S.C. 801 et seq.). For purposes of any requirements that relate to the physical security of registered manufacturers and registered distributors, the final order shall treat such drug, when the drug is manufactured, distributed, or possessed in accordance with an exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act [ 21 U.S.C. 355(i) ] (whether the exemption involved is authorized before, on, or after the date of the enactment of this Act [ Feb. 18, 2000 ]), as being in the same schedule as that recommended by the Secretary of Health and Human Services for the drug when the drug is the subject of an authorized investigational new drug application (relating to such section 505(i)). The recommendation referred to in the preceding sentence is contained in the first paragraph of the letter transmitted on May 19, 1999 , by such Secretary (acting through the Assistant Secretary for Health) to the Attorney General (acting through the Deputy Administrator of the Drug Enforcement Administration), which letter was in response to the letter transmitted by the Attorney General (acting through such Deputy Administrator) on September 16, 1997 . In publishing the final order in the Federal Register, the Attorney General shall publish a copy of the letter that was transmitted by the Secretary of Health and Human Services. In the case of gamma hydroxybutyric acid that is contained in a drug product for which an application is approved under section 505 of the Federal Food, Drug, and Cosmetic Act [ 21 U.S.C. 355 ] (whether the application involved is approved before, on, or after the date of the enactment of this Act [ Feb. 18, 2000 ]), the final order shall schedule such drug in the same schedule as that recommended by the Secretary of Health and Human Services for authorized formulations of the drug. The recommendation referred to in the preceding sentence is contained in the last sentence of the fourth paragraph of the letter referred to in subparagraph (A) with respect to May 19, 1999 . If the final order is not issued within the period specified in paragraph (1), gamma hydroxybutyric acid (together with its salts, isomers, and salts of isomers) is deemed to be scheduled under section 202(c) of the Controlled Substances Act [ 21 U.S.C. 812(c) ] in accordance with the policies described in paragraph (1), as if the Attorney General had issued a final order in accordance with such paragraph.”
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