[Federal Register Volume 77, Number 190 (Monday, October 1, 2012)]
[Notices]
[Pages 59980-59983]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-24089]



[[Page 59980]]

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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-365]


Established Aggregate Production Quotas for Schedule I and II 
Controlled Substances and Established Assessment of Annual Needs for 
the List I Chemicals Ephedrine, Pseudoephedrine, and 
Phenylpropanolamine for 2013

AGENCY: Drug Enforcement Administration (DEA), Department of Justice.

ACTION: Notice.

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SUMMARY: This notice establishes the initial 2013 aggregate production 
quotas for controlled substances in schedules I and II of the 
Controlled Substances Act (CSA) and assessment of annual needs for the 
list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine.

DATES: Effective Date: October 1, 2012.

FOR FURTHER INFORMATION CONTACT: John W. Partridge, Executive 
Assistant, Office of Diversion Control, Drug Enforcement 
Administration, 8701 Morrissette Drive, Springfield, VA 22152, 
Telephone: (202) 307-4654.

SUPPLEMENTARY INFORMATION: Section 306 of the CSA (21 U.S.C. 826) 
requires the Attorney General to establish aggregate production quotas 
for each basic class of controlled substance listed in schedules I and 
II and for the list I chemicals ephedrine, pseudoephedrine, and 
phenylpropanolamine. This responsibility has been delegated to the 
Administrator of the DEA by 28 CFR 0.100. The Administrator, in turn, 
has redelegated this function to the Deputy Administrator pursuant to 
28 CFR 0.104.
    The 2013 aggregate production quotas and assessment of annual needs 
represent those quantities of schedule I and II controlled substances 
and the list I chemicals ephedrine, pseudoephedrine, and 
phenylpropanolamine to be manufactured in the United States in 2013 to 
provide for the estimated medical, scientific, research, and industrial 
needs of the United States, lawful export requirements, and the 
establishment and maintenance of reserve stocks. These quotas include 
imports of ephedrine, pseudoephedrine, and phenylpropanolamine but do 
not include imports of controlled substances for use in industrial 
processes.
    On August 3, 2012, a notice titled, ``Proposed Aggregate Production 
Quotas for Schedule I and II Controlled Substances and Proposed 
Assessment of Annual Needs for the List I Chemicals Ephedrine, 
Pseudoephedrine, and Phenylpropanolamine for 2013,'' was published in 
the Federal Register (77 FR 46519). That notice proposed the 2013 
aggregate production quotas for each basic class of controlled 
substance listed in schedules I and II and the 2013 assessment of 
annual needs for the list I chemicals ephedrine, pseudoephedrine, and 
phenylpropanolamine. All interested persons were invited to comment on 
or object to the proposed aggregate production quotas and the proposed 
assessment of annual needs on or before September 4, 2012.
    Five comments (four from DEA-registered manufacturers and one from 
a non-registrant) were received within the published comment period, 
offering comments on a total of 20 schedule I and II controlled 
substances and one list I chemical. Commenters stated that the proposed 
aggregate production quotas for amphetamine (for conversion), 
amphetamine (for sale), codeine (for conversion), codeine (for sale), 
gamma hydroxybutyric acid, hydrocodone (for sale), hydromorphone, 
lisdexamfetamine, meperidine, methamphetamine, methylphenidate, 
morphine (for conversion), morphine (for sale), noroxymorphone (for 
conversion), oripavine, oxycodone (for sale), oxymorphone (for 
conversion), oxymorphone (for sale), remifentanil, and sufentanil were 
insufficient to provide for the estimated medical, scientific, 
research, and industrial needs of the United States, export 
requirements, and the establishment and maintenance of reserve stocks. 
One commenter stated that the proposed assessment of annual needs quota 
for phenylpropanolamine (for conversion) was insufficient to provide 
for the estimated medical, scientific, research, and industrial needs 
of the United States, export requirements, and the establishment and 
maintenance of reserve stocks.
    In determining the 2013 aggregate production quotas and assessment 
of annual needs, DEA has taken into consideration the above comments 
along with the factors set forth at 21 CFR 1303.11 and 21 CFR 1315.11, 
in accordance with 21 U.S.C. 826(a), and other relevant factors, 
including the consideration of 2012 manufacturing quotas, current 2012 
sales and inventories, 2013 export requirements, industrial use, 
additional applications for quotas, as well as information on research 
and product development requirements. Based on this information, DEA 
has determined that adjustments to the proposed aggregate production 
quotas and assessment of annual needs for 3,4-methylenedioxy-N-
methylcathinone (methylone), 3,4,methylenedioxypyrovalerone (MDPV), 4-
methyl-N-methylcathinone (mephedrone), N-benzylpiperazine, amphetamine 
(for conversion), amphetamine (for sale), hydrocodone (for sale), 
hydromorphone, lisdexamfetamine, methylphenidate, morphine (for sale), 
oxycodone (for sale), oxymorphone (for conversion), remifentanil, 
sufentanil, tapentadol, ephedrine (for conversion), ephedrine (for 
sale), phenylpropanolamine (for sale), and pseudoephedrine (for sale) 
are warranted. This notice reflects those adjustments.
    Regarding codeine (for conversion), codeine (for sale), gamma 
hydroxybutyric acid, meperidine, methamphetamine, morphine (for 
conversion), noroxymorphone (for conversion), oripavine, oxymorphone 
(for sale), and phenylpropanolamine (for conversion), DEA has 
determined that the proposed initial 2013 aggregate production quotas 
and assessment of annual needs are sufficient to meet the current 2013 
estimated medical, scientific, research, and industrial needs of the 
United States. This notice finalizes these aggregate production quotas 
at the same amounts as proposed.
    DEA also specifically considered that inventory allowances granted 
to individual manufacturers may not always result in the availability 
of sufficient quantities to maintain an adequate reserve stock pursuant 
to 21 U.S.C. 826(a), as intended. See 21 CFR 1303.24. This would be 
concerning if a natural disaster or other unforeseen event resulted in 
substantial disruption to the amount of controlled substances available 
to provide for legitimate public need. As such, DEA included in all 
schedule II aggregate production quotas, and certain schedule I 
aggregate production quotas, an additional 25% of the estimated 
medical, scientific, and research needs as part of the amount necessary 
to ensure the establishment and maintenance of reserve stocks. The 
established aggregate production quotas reflect these included amounts. 
This action will not affect the ability of manufacturers to maintain 
inventory allowances as specified by regulation. DEA expects that 
maintaining this reserve in certain established aggregate production 
quotas will mitigate adverse public effects if an unforeseen event 
resulted in substantial disruption to the amount of controlled 
substances available to provide for legitimate

[[Page 59981]]

public need, as determined by DEA. DEA does not anticipate utilizing 
the reserve in the absence of these circumstances.
    In accordance with 21 U.S.C. 826, 21 CFR 1303.11, and 21 CFR 
1315.11, the Deputy Administrator hereby establishes the 2013 aggregate 
production quotas for the following schedule I and II controlled 
substances and the 2013 assessment of annual needs for the list I 
chemicals ephedrine, pseudoephedrine, and phenylpropanolamine, 
expressed in grams of anhydrous acid or base, as follows:

------------------------------------------------------------------------
                                                        Established 2013
                     Basic class                             quotas
------------------------------------------------------------------------
                               Schedule I
------------------------------------------------------------------------
1-(5-Fluoropentyl)-3-(1-naphthoyl)indole (AM2201)....               45 g
1-(5-Fluoropentyl)-3-(2-iodobenzoyl)indole (AM694)...               45 g
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-Cyclohexylethyl-3-(2-methoxyphenylacetyl)indole (SR-              45 g
 18 and RCS-8).......................................
1-Hexyl-3-(1-naphthoyl)indole (JWH-019)..............               45 g
1-Methyl-4-phenyl-4-propionoxypiperidine.............                2 g
1-Pentyl-3-(1-naphthoyl)indole (JWH-018 and AM678)...               45 g
1-Pentyl-3-(2-chlorophenylacetyl)indole (JWH-203)....               45 g
1-Pentyl-3-(2-methoxyphenylacetyl)indole (JWH-250)...               45 g
1-Pentyl-3-(4-chloro-1-naphthoyl)indole (JWH-398)....               45 g
1-Pentyl-3-(4-methyl-1-naphthoyl)indole (JWH-122)....               45 g
1-Pentyl-3-[(4-methoxy)-benzoyl]indole (SR-19, RCS-4)               45 g
1-Pentyl-3-[1-(4-methoxynaphthoyl)]indole (JWH-081)..               45 g
2-(2,5-Dimethoxy-4-(n)-propylphenyl)ethanamine (2C-P)               15 g
2-(2,5-Dimethoxy-4-ethylphenyl)ethanamine (2C-E).....               15 g
2-(2,5-Dimethoxy-4-methylphenyl)ethanamine (2C-D)....               15 g
2-(2,5-Dimethoxy-4-nitro-phenyl)ethanamine (2C-N)....               15 g
2-(2,5-Dimethoxyphenyl)ethanamine (2C-H).............               15 g
2-(4-Chloro-2,5-dimethoxyphenyl)ethanamine (2C-C)....               15 g
2-(4-Iodo-2,5-dimethoxyphenyl)ethanamine (2C-I)......               15 g
2,5-Dimethoxy-4-ethylamphetamine (DOET)..............               12 g
2,5-Dimethoxy-4-n-propylthiophenethylamine...........               12 g
2,5-Dimethoxyamphetamine.............................               12 g
2-[4-(Ethylthio)-2,5-dimethoxyphenyl]ethanamine (2C-T-              15 g
 2)..................................................
2-[4-(Isopropylthio)-2,5-dimethoxyphenyl]ethanamine                 15 g
 (2C-T-4)............................................
3,4,5-Trimethoxyamphetamine..........................               12 g
3,4-Methylenedioxyamphetamine (MDA)..................               30 g
3,4-Methylenedioxymethamphetamine (MDMA).............               35 g
3,4-Methylenedioxy-N-ethylamphetamine (MDEA).........               24 g
3,4-Methylenedioxy-N-methylcathinone (methylone).....               35 g
3,4-Methylenedioxypyrovalerone (MDPV)................               25 g
3-Methylfentanyl.....................................                2 g
3-Methylthiofentanyl.................................                2 g
4-Bromo-2,5-dimethoxyamphetamine (DOB)...............               12 g
4-Bromo-2,5-dimethoxyphenethylamine (2-CB)...........               12 g
4-Methoxyamphetamine.................................               88 g
4-Methyl-2,5-dimethoxyamphetamine (DOM)..............               12 g
4-Methylaminorex.....................................               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 (cannabicyclohexanol or CP-47, 497 C8-
 homolog)............................................
5-Methoxy-3,4-methylenedioxyamphetamine..............               12 g
5-Methoxy-N,N-diisopropyltryptamine..................               12 g
5-Methoxy-N,N-dimethyltryptamine.....................               10 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

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Betaprodine..........................................                2 g
Bufotenine...........................................                3 g
Cathinone............................................               12 g
Codeine-N-oxide......................................              602 g
Desomorphine.........................................                5 g
Diethyltryptamine....................................               12 g
Difenoxin............................................               50 g
Dihydromorphine......................................        3,300,000 g
Dimethyltryptamine...................................               18 g
Gamma-hydroxybutyric acid............................       46,250,000 g
Heroin...............................................               25 g
Hydromorphinol.......................................               54 g
Hydroxypethidine.....................................                2 g
Ibogaine.............................................                5 g
Lysergic acid diethylamide (LSD).....................               30 g
Marihuana............................................           21,000 g
Mescaline............................................               13 g
Methaqualone.........................................               10 g
Methcathinone........................................               14 g
Methyldihydromorphine................................                2 g
Morphine-N-oxide.....................................              655 g
N,N-Dimethylamphetamine..............................               12 g
N-Benzylpiperazine...................................               15 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.............................................                4 g
Tetrahydrocannabinols................................          491,000 g
Thiofentanyl.........................................                2 g
Tilidine.............................................               10 g
Trimeperidine........................................                2 g
------------------------------------------------------------------------
                               Schedule II
------------------------------------------------------------------------
1-Phenylcyclohexylamine..............................                3 g
1-Piperdinocyclohexanecarbonitrile...................               21 g
4-Anilino-N-phenethyl-4-piperidine (ANPP)............        2,250,000 g
Alfentanil...........................................           38,250 g
Alphaprodine.........................................                3 g
Amobarbital..........................................                9 g
Amphetamine (for conversion).........................       22,875,000 g
Amphetamine (for sale)...............................       42,625,000 g
Carfentanil..........................................                6 g
Cocaine..............................................          240,000 g
Codeine (for conversion).............................       81,250,000 g
Codeine (for sale)...................................       49,506,250 g
Dextropropoxyphene...................................               19 g
Dihydrocodeine.......................................          250,000 g
Diphenoxylate........................................          750,000 g
Ecgonine.............................................          127,500 g
Ethylmorphine........................................                3 g
Fentanyl.............................................        2,108,750 g
Glutethimide.........................................                3 g
Hydrocodone (for sale)...............................       99,625,000 g
Hydromorphone........................................        5,968,750 g
Isomethadone.........................................                5 g
Levo-alphacetylmethadol (LAAM).......................                4 g
Levomethorphan.......................................                6 g
Levorphanol..........................................            4,500 g
Lisdexamfetamine.....................................       21,000,000 g
Meperidine...........................................        6,875,000 g
Meperidine Intermediate-A............................                6 g
Meperidine Intermediate-B............................               11 g
Meperidine Intermediate-C............................                6 g
Metazocine...........................................                6 g

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Methadone (for sale).................................       25,000,000 g
Methadone Intermediate...............................       32,500,000 g
Methamphetamine......................................        3,912,500 g
------------------------------------------------------------------------
[987,500 grams of levo-desoxyephedrine for use in a non-controlled, non-
 prescription product; 2,863,750 grams for methamphetamine mostly for
 conversion to a schedule III product; and 61,250 grams for
 methamphetamine (for sale)].
------------------------------------------------------------------------
Methylphenidate......................................       80,750,000 g
Morphine (for conversion)............................      103,750,000 g
Morphine (for sale)..................................       60,250,000 g
Nabilone.............................................           25,628 g
Noroxymorphone (for conversion)......................        9,000,000 g
Noroxymorphone (for sale)............................          508,750 g
Opium (powder).......................................           91,250 g
Opium (tincture).....................................        1,287,500 g
Oripavine............................................       22,750,000 g
Oxycodone (for conversion)...........................       10,250,000 g
Oxycodone (for sale).................................      131,500,000 g
Oxymorphone (for conversion).........................       18,375,000 g
Oxymorphone (for sale)...............................        6,875,000 g
Pentobarbital........................................       42,500,000 g
Phenazocine..........................................                6 g
Phencyclidine........................................               30 g
Phenmetrazine........................................                3 g
Phenylacetone........................................       20,000,000 g
Racemethorphan.......................................                3 g
Remifentanil.........................................            3,750 g
Secobarbital.........................................          215,003 g
Sufentanil...........................................            6,255 g
Tapentadol...........................................       13,750,000 g
Thebaine.............................................      145,000,000 g
------------------------------------------------------------------------
                            List I Chemicals
------------------------------------------------------------------------
Ephedrine (for conversion)...........................       15,100,000 g
Ephedrine (for sale).................................        3,500,000 g
Phenylpropanolamine (for conversion).................       25,700,000 g
Phenylpropanolamine (for sale).......................        6,100,000 g
Pseudoephedrine (for sale)...........................      225,000,000 g
------------------------------------------------------------------------

    The Deputy Administrator also establishes aggregate production 
quotas for all other schedule I and II controlled substances included 
in 21 CFR 1308.11 and 1308.12 at zero. Pursuant to 21 CFR 1303.13 and 
21 CFR 1315.13, upon consideration of the relevant factors, the Deputy 
Administrator may adjust the 2013 aggregate production quotas and 
assessment of annual needs as needed.

    Dated: September 25, 2012.
Thomas M. Harrigan,
Deputy Administrator.
[FR Doc. 2012-24089 Filed 9-28-12; 8:45 am]
BILLING CODE 4410-09-P