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Daily Rules, Proposed Rules, and Notices of the Federal Government

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-363]

Controlled Substances: Final Adjusted Aggregate Production Quotas for 2012

AGENCY: Drug Enforcement Administration (DEA), Department of Justice.
ACTION: Notice.
SUMMARY: This notice establishes final adjusted 2012 aggregate production quotas for controlled substances in Schedules I and II of the Controlled Substances Act (CSA).
FOR FURTHER INFORMATION CONTACT: John W. Partridge, Chief, Liaison and Policy Section, Drug Enforcement Administration, 8701 Morrissette Drive, Springfield, VA 22152, Telephone: (202) 307-4654.
SUPPLEMENTARY INFORMATION:

Background

Section 306(a) of the CSA (21 U.S.C. 826) requires that the Attorney General establish aggregate production quotas for each basic class of controlled substance listed in Schedules I and II. This responsibility has been delegated to the Administrator of the DEA by 28 CFR 0.100. In accordance with 21 U.S.C. 826 and 21 CFR 1303.11, DEA published in theFederal Registeron December 15, 2011, notice of the established 2012 aggregate production quotas for controlled substances in Schedules I and II (76 FR 78044). That notice stated that the Administrator would adjust, as needed, the established aggregate production quotas in 2012 as provided for in 21 CFR 1303.13. The 2012 proposed adjusted aggregate production quotas were subsequently published in theFederal Registeron July 5, 2012 (77 FR 39737) in consideration of the outlined criteria. All interested persons were invited to comment on or object to the proposed adjusted aggregate production quotas on or before August 6, 2012.

Analysis for Final Adjusted 2012 Aggregate Production Quotas

Consideration has been given to the criteria outlined in the July 5, 2012, notice of proposed adjusted aggregate production quotas in accordance with 21 CFR 1303.13. In addition, nine companies, eight DEA registered manufacturers and one non-registrant, submitted timely comments regarding a total of 25 Schedule I and II controlled substances. Comments received proposed that the aggregate production quotas for 3,4-Methylenedioxy-N-Methylcathinone (methylone), alfentanil, amphetamine (for conversion), amphetamine (for sale), codeine (for conversion), codeine (for sale), desomorphine, dihydromorphine, hydrocodone (for sale), hydromorphone, levomethorphan, lisdexamfetamine, methadone intermediate, methylphenidate, morphine (for conversion), morphine (for sale), noroxymorphone (for conversion), noroxymorphone (for sale), oripavine, oxycodone (for conversion), oxycodone (for sale), oxymorphone (for conversion), oxymorphone (for sale), sufentanil, and tapentadol were insufficient to provide for the estimated medical, scientific, research, and industrial needs of the United States, for export requirements, and for the establishment and maintenance of reserve stocks.

DEA has taken into consideration the above comments along with the relevant 2011 year-end inventories, initial 2012 manufacturing quotas, 2012 export requirements, actual and projected 2012 sales, research and product development requirements, and additional applications received. Based on all of the above, the Administrator has determined that the proposed adjusted 2012 aggregate production quotas for 3,4-Methylenedioxypyrovalerone (MDPV), 3,4-Methylenedioxy-N-Methylcathinone (methylone), 4-Methyl-N-Methylcathinone (mephedrone), alfentanil, amphetamine (for conversion), desomorphine, diethyltryptamine, dihydromorphine, gamma hydroxybutyric acid, hydrocodone (for sale), hydromorphone, levomethorphan, methadone, methadone intermediate, methylphenidate, morphine (for sale), oxycodone (for conversion), oxycodone (for sale), and sufentanil required additional consideration and hereby further adjusts the 2012 aggregate production quotas for those substances. Regarding amphetamine (for sale), codeine (for conversion), codeine (for sale), morphine (for conversion), noroxymorphone (for conversion), noroxymorphone (for sale), oripavine, oxymorphone (for conversion), oxymorphone (for sale), and tapentadol, the Administrator hereby determines that the proposed adjusted 2012 aggregate production quotas for these substances as published on July 5, 2012, at 77 FR 39737 are sufficient to meet the current 2012 estimated medical, scientific, research, and industrial needs of the United States and to provide for adequate inventories. Pursuant to the above, the Administrator hereby establishes the 2012 final aggregate production quotas for Schedule I and II controlled substances, expressed in grams of anhydrous acid or base, as follows:

Final adjusted 2012 quotas Basic Class—Schedule I 1-[1-(2-Thienyl)cyclohexyl]piperidine 5 g 1-[2-(4-Morpholinyl)ethyl]-3-(1-naphthoyl)indole (JWH-200) 45 g 1-Butyl-3-(1-naphthoyl)indole (JWH-073) 45 g 1-Methyl-4-phenyl-4-propionoxypiperidine 2 g 1-Pentyl-3-(1-naphthoyl)indole (JWH-018) 45 g 2,5-Dimethoxyamphetamine 12 g 2,5-Dimethoxy-4-ethylamphetamine (DOET) 12 g 2,5-Dimethoxy-4-n-propylthiophenethylamine 12 g 3-Methylfentanyl 2 g 3-Methylthiofentanyl 2 g 3,4-Methylenedioxyamphetamine (MDA) 30 g 3,4-Methylenedioxy-N-methylcathinone (methylone) 30 g 3,4-Methylenedioxy-N-ethylamphetamine (MDEA) 24 g 3,4-Methylenedioxymethamphetamine (MDMA) 30 g 3,4-Methylenedioxypyrovalerone (MDPV) 20 g 3,4,5-Trimethoxyamphetamine 12 g 4-Bromo-2,5-dimethoxyamphetamine (DOB) 12 g 4-Bromo-2,5-dimethoxyphenethylamine (2-CB) 12 g 4-Methoxyamphetamine 88 g 4-Methylaminorex 12 g 4-Methyl-2,5-dimethoxyamphetamine (DOM) 12 g 4-Methyl-N-methylcathinone (mephedrone) 25 g 5-(1,1-Dimethylheptyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-phenol 68 g 5-(1,1-Dimethyloctyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-phenol 53 g 5-Methoxy-3,4-methylenedioxyamphetamine 12 g 5-Methoxy-N,N-diisopropyltryptamine 12 g Acetyl-alpha-methylfentanyl 2 g Acetyldihydrocodeine 2 g Acetylmethadol 2 g Allylprodine 2 g Alphacetylmethadol 2 g Alpha-ethyltryptamine 12 g Alphameprodine 2 g Alphamethadol 2 g Alpha-methylfentanyl 2 g Alpha-methylthiofentanyl 2 g Alpha-methyltryptamine (AMT) 12 g Aminorex 12 g Benzylmorphine 2 g Betacetylmethadol 2 g Beta-hydroxy-3-methylfentanyl 2 g Beta-hydroxyfentanyl 2 g Betameprodine 2 g Betamethadol 2 g Betaprodine 2 g Bufotenine 3 g Cathinone 12 g Codeine-N-oxide 602 g Desomorphine 10 g Diethyltryptamine 18 g Difenoxin 50 g Dihydromorphine 3,750,000 g Dimethyltryptamine 18 g Gamma-hydroxybutyric acid 37,000,000 g Heroin 20 g Hydromorphinol 54 g Hydroxypethidine 2 g Ibogaine 5 g Lysergic acid diethylamide (LSD) 16 g Marihuana 21,000 g Mescaline 13 g Methaqualone 10 g Methcathinone 12 g Methyldihydromorphine 2 g Morphine-N-oxide 655 g N-Benzylpiperazine 12 g N,N-Dimethylamphetamine 12 g N-Ethylamphetamine 12 g N-Hydroxy-3,4-methylenedioxyamphetamine 12 g Noracymethadol 2 g Norlevorphanol 52 g Normethadone 2 g Normorphine 18 g Para-fluorofentanyl 2 g Phenomorphan 2 g Pholcodine 2 g Properidine 2 g Psilocybin 2 g Psilocyn 2 g Tetrahydrocannabinols 393,000 g Thiofentanyl 2 g Tilidine 10 g Trimeperidine 2 g
Basic Class—Schedule II 1-Phenylcyclohexylamine 2 g 1-Piperdinocyclohexanecarbonitrile 27 g 4-Anilino-N-phenethyl-4-piperidine (ANPP) 1,800,000 g Alfentanil 29,002 g Alphaprodine 2 g Amobarbital 40,007 g Amphetamine (for conversion) 13,300,000 g Amphetamine (for sale) 33,400,000 g Carfentanil 5 g Cocaine 216,000 g Codeine (for conversion) 65,000,000 g Codeine (for sale) 39,605,000 g Dextropropoxyphene 7 g Dihydrocodeine 400,000 g Diphenoxylate 900,000 g Ecgonine 83,000 g Ethylmorphine 2 g Fentanyl 1,428,000 g Glutethimide 2 g Hydrocodone (for sale) 79,700,000 g Hydromorphone 4,207,000 g Isomethadone 4 g Levo-alphacetylmethadol (LAAM) 3 g Levomethorphan 10 g Levorphanol 3,600 g Lisdexamfetamine 12,000,000 g Meperidine 5,500,000 g Meperidine Intermediate-A 5 g Meperidine Intermediate-B 9 g Meperidine Intermediate-C 5 g Metazocine 5 g Methadone (for sale) 23,100,000 g Methadone Intermediate 29,970,000 g Methamphetamine 3,130,000 g [750,000 grams of levo-desoxyephedrine for use in a non-controlled, non-prescription product; 2,331,000 grams for methamphetamine mostly for conversion to a schedule III product; and 49,000 grams for methamphetamine (for sale)] Methylphenidate 64,600,000 g Morphine (for conversion) 83,000,000 g Morphine (for sale) 48,200,000 g Nabilone 20,502 g Noroxymorphone (for conversion) 7,200,000 g Noroxymorphone (for sale) 1,981,000 g Opium (powder) 73,000 g Opium (tincture) 1,000,000 g Oripavine 15,300,000 g Oxycodone (for conversion) 7,600,000 g Oxycodone (for sale) 105,200,000 g Oxymorphone (for conversion) 12,800,000 g Oxymorphone (for sale) 5,500,000 g Pentobarbital 34,000,000 g Phenazocine 5 g Phencyclidine 24 g Phenmetrazine 2 g Phenylacetone 16,000,000 g Racemethorphan 2 g Remifentanil 2,500 g Secobarbital 336,002 g Sufentanil 6,730 g Tapentadol 5,400,000 g Thebaine 116,000,000 g

Aggregate production quotas for all other Schedule I and II controlled substances included in 21 CFR 1308.11 and 1308.12 remain at zero.

Dated: August 31, 2012. Michele M. Leonhart, Administrator.