[Federal Register Volume 77, Number 175 (Monday, September 10, 2012)]
[Notices]
[Pages 55500-55503]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-22128]
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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.
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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 the Federal Register on 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 the Federal Register on 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:
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Final adjusted
2012 quotas
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Basic Class--Schedule I
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1-[1-(2-Thienyl)cyclohexyl]piperidine................ 5 g
1-[2-(4-Morpholinyl)ethyl]-3-(1-naphthoyl)indole (JWH- 45 g
200)................................................
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
[[Page 55501]]
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- 68 g
hydroxycyclohexyl]-phenol...........................
5-(1,1-Dimethyloctyl)-2-[(1R,3S)-3-hydroxycyclohexyl]- 53 g
phenol..............................................
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
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[[Page 55502]]
Basic Class--Schedule II
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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
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[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)]
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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
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[[Page 55503]]
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.
[FR Doc. 2012-22128 Filed 9-7-12; 8:45 am]
BILLING CODE 4410-09-P