Login

21 C.F.R. § 1308.12 : Food and Drugs — DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE — SCHEDULES OF CONTROLLED SUBSTANCES —SCHEDULES — Schedule II

(a) Schedule II shall consist of the drugs and other substances, by whatever official name, common or usual name, chemical name, or brand name designated, listed in this section. Each drug or substance has been assigned the Controlled Substances Code Number set forth opposite it.
(b) Substances, vegetable origin or chemical synthesis. Unless specifically excepted or unless listed in another schedule, any of the following substances whether produced directly or indirectly by extraction from substances of vegetable origin, or independently by means of chemical synthesis, or by a combination of extraction and chemical synthesis:
(1) Opium and opiate, and any salt, compound, derivative, or preparation of opium or opiate excluding apomorphine, thebaine-derived butorphanol, dextrorphan, nalbuphine, naldemedine, nalmefene, naloxegol, naloxone, 6[BETA]-naltrexol, naltrexone, and samidorphan, and their respective salts, but including the following:

(i) Codeine 9050
(ii) Dihydroetorphine 9334
(iii) Ethylmorphine 9190
(iv) Etorphine hydrochloride 9059
(v) Granulated opium 9640
(vi) Hydrocodone 9193
(vii) Hydromorphone 9150
(viii) Metopon 9260
(ix) Morphine 9300
(x) Noroxymorphone 9668
(xi) Opium extracts 9610
(xii) Opium fluid 9620
(xiii) Oripavine 9330
(xiv) Oxycodone 9143
(xv) Oxymorphone 9652
(xvi) Powdered opium 9639
(xvii) Raw opium 9600
(xviii) Thebaine 9333
(xix) Tincture of opium 9630

(2) Any salt, compound, derivative, or preparation thereof which is chemically equivalent or identical with any of the substances referred to in paragraph (b) (1) of this section, except that these substances shall not include the isoquinoline alkaloids of opium.
(3) Opium poppy and poppy straw.
(4) Coca leaves (9040) and any salt, compound, derivative or preparation of coca leaves (including cocaine (9041) and ecgonine (9180) and their salts, isomers, derivatives and salts of isomers and derivatives), and any salt, compound, derivative, or preparation thereof which is chemically equivalent or identical with any of these substances, except that the substances shall not include:
(i) Decocainized coca leaves or extraction of coca leaves, which extractions do not contain cocaine or ecgonine;
(ii) [ 123I]ioflupane; or
(iii) [ 18F]FP-CIT.
(5) Concentrate of poppy straw (the crude extract of poppy straw in either liquid, solid or powder form which contains the phenanthrene alkaloids of the opium poppy), 9670.
(c) Opiates. Unless specifically excepted or unless in another schedule any of the following opiates, including its isomers, esters, ethers, salts and salts of isomers, esters and ethers whenever the existence of such isomers, esters, ethers, and salts is possible within the specific chemical designation, dextrorphan and levopropoxyphene excepted:

(1) Alfentanil 9737
(2) Alphaprodine 9010
(3) Anileridine 9020
(4) Bezitramide 9800
(5) Bulk dextropropoxyphene (non-dosage forms) 9273
(6) Carfentanil 9743
(7) Dihydrocodeine 9120
(8) Diphenoxylate 9170
(9) Fentanyl 9801
(10) Isomethadone 9226
(11) Levo-alphacetylmethadol 9648
[Some other names: levo-alpha-acetylmethadol, levomethadyl acetate, LAAM]
(12) Levomethorphan 9210
(13) Levorphanol 9220
(14) Metazocine 9240
(15) Methadone 9250
(16) Methadone-Intermediate, 4-cyano-2-dimethylamino-4,4-diphenyl butane 9254
(17) Moramide-Intermediate, 2-methyl-3-morpholino-1, 1-diphenylpropane-carboxylic acid 9802
(18) Oliceridine (N-[(3-methoxythiophen-2-yl)methyl]({2-[(9R)-9-(pyridin-2-yl)-6-oxaspiro[4.5]decan-9-yl]ethyl})amine) 9245
(19) Pethidine (meperidine) 9230
(20) Pethidine-Intermediate-A, 4-cyano-1-methyl-4-phenylpiperidine 9232
(21) Pethidine-Intermediate-B, ethyl-4-phenylpiperidine-4-carboxylate 9233
(22) Pethidine-Intermediate-C, 1-methyl-4-phenylpiperidine-4-carboxylic acid 9234
(23) Phenazocine 9715
(24) Piminodine 9730
(25) Racemethorphan 9732
(26) Racemorphan 9733
(27) Remifentanil 9739
(28) Sufentanil 9740
(29) Tapentadol 9780
(30) Thiafentanil 9729

(d) Stimulants. Unless specifically excepted or unless listed in another schedule, any material, compound, mixture, or preparation which contains any quantity of the following substances having a stimulant effect on the central nervous system:

(1) Amphetamine, its salts, optical isomers, and salts of its optical isomers 1100
(2) Methamphetamine, its salts, isomers, and salts of its isomers 1105
(3) Phenmetrazine and its salts 1631
(4) Methylphenidate 1724
(5) Lisdexamfetamine, its salts, isomers, and salts of its isomers 1205.

(e) Depressants. Unless specifically excepted or unless listed in another schedule, any material, compound, mixture, or preparation which contains any quantity of the following substances having a depressant effect on the central nervous system, including its salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible within the specific chemical designation:

(1) Amobarbital 2125
(2) Glutethimide 2550
(3) Pentobarbital 2270
(4) Phencyclidine 7471
(5) Secobarbital 2315

(f) Hallucinogenic substances.

(1) Nabilone 7379
[Another name for nabilone: (±)-trans-3-(1,1-dimethylheptyl)-6,6a,7,8,10,10a-hexahydro-1-hydroxy-6,6-dimethyl-9H-dibenzo[b,d]pyran-9-one]
(2) Dronabinol [(-)-delta-9-trans tetrahydrocannabinol] in an oral solution in a drug product approved for marketing by the U.S. Food and Drug Administration (7365)

(g) Immediate precursors. Unless specifically excepted or unless listed in another schedule, any material, compound, mixture, or preparation which contains any quantity of the following substances:
(1) Immediate precursor to amphetamine and methamphetamine:

(i) Phenylacetone 8501
Some trade or other names: phenyl-2-propanone; P2P; benzyl methyl ketone; methyl benzyl ketone;

(2) Immediate precursors to phencyclidine (PCP):

(i) 1-phenylcyclohexylamine 7460
(ii) 1-piperidinocyclohexanecarbonitrile (PCC) 8603

(3) Immediate precursor to fentanyl:

(i) 4-anilino-N-phenethylpiperidine (ANPP) 8333
(ii) N-phenyl-N-(piperidin-4-yl)propionamide (norfentanyl) 8366

21 C.F.R. §1308.12

39 FR 22142, 6/20/1974; 81 FR 58839, 8/26/2016; 82 FR 14820, 3/23/2017; 82 FR 45438, 9/29/2017; 84 FR 2449, 2/7/2019; 84 FR 41914, 8/16/2019; 85 FR 4217, 1/24/2020; 85 FR 21325, 5/18/2020; 85 FR 68753, 10/30/2020; 86 FR 20286, 4/19/2021; 86 FR 30774, 7/12/2021; 87 FR 70717, 12/21/2022

For FEDERAL REGISTER citations affecting § 1308.12, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and at .