[Federal Register Volume 78, Number 174 (Monday, September 9, 2013)]
[Notices]
[Pages 55099-55103]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-21797]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-378]


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 2014

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

ACTION: Notice.

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SUMMARY: This notice establishes the initial 2014 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: September 9, 2013.

FOR FURTHER INFORMATION CONTACT: Ruth A. Carter, Chief, Policy 
Evaluation and Analysis Section, Office of Diversion Control, Drug 
Enforcement Administration, 8701 Morrissette Drive, Springfield, VA 
22152, Telephone: (202) 598-6812.

SUPPLEMENTARY INFORMATION:

Background

    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 2014 aggregate production quotas and assessment of annual needs 
represent those quantities of Schedules I and II controlled substances 
and the List I chemicals ephedrine, pseudoephedrine, and 
phenylpropanolamine to be manufactured in the United States in 2014 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 July 3, 2013, 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 2014,'' was published in 
the Federal Register (78 FR 40186). That notice proposed the 2014 
aggregate production quotas for each basic class of controlled 
substance listed in Schedules I and II and the 2014 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 August 2, 2013.

Comments Received

    DEA received seven comments from DEA-registered manufacturers 
within the published comment period on a total of 23 Schedule I and II 
controlled substances and one List I chemical. Commenters stated that 
the proposed aggregate production quotas for (1-Pentyl-1H-indol-3-
yl)(2,2,3,3-tetramethylcyclopropyl)methanone (UR-144), [1-(5-fluoro-
pentyl)-1H-indol-3-yl](2,2,3,3-tetramethylcyclopropyl)methanone 
(XLR11), N-(1-adamantyl)-1-pentyl-1H-indazole-3-carboxamide (AKB48), 
cathinone, amphetamine (for sale), codeine (for conversion), codeine 
(for sale), fentanyl, hydrocodone (for sale), hydromorphone, 
levomethorphan, methylphenidate, morphine (for conversion), morphine 
(for sale), noroxymorphone (for conversion), oripavine, oxycodone (for 
sale), oxymorphone (for conversion), oxymorphone (for sale), 
phenylacetone, tapentadol, tetrahydrocannabinol, and thebaine 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.

Determination of 2014 Aggregate Production Quotas and Assessment of 
Annual Needs

    In determining the 2014 aggregate production quotas and assessment 
of annual needs, the 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 2013 manufacturing quotas, 
current 2013 sales and inventories, 2014 export requirements, 
industrial use, additional applications for quotas, as well as 
information on research and product development requirements. Based on 
this information, the DEA has determined that adjustments to the 
proposed aggregate production quotas and assessment of annual needs for 
1-[1-(2-Thienyl)cyclohexyl]piperidine, carfentanil, cathinone, 
dihydromorphine, dimethyltryptamine, ecgonine, hydromorphone, 
levomethorphan, lysergic acid diethylamide, metazocine, 
methamphetamine, d-methamphetamine (for conversion), methyldesorphine, 
noroxymorphone (for conversion), oxymorphone (for conversion), 
phencyclidine, phenylacetone, ephedrine (for conversion), ephedrine 
(for sale),

[[Page 55100]]

phenylpropanolamine (for conversion), and pseudoephedrine (for sale) 
are warranted. This notice reflects those adjustments.
    Regarding (1-Pentyl-1H-indol-3-yl)(2,2,3,3-
tetramethylcyclopropyl)methanone (UR-144), [1-(5-fluoro-pentyl)-1H-
indol-3-yl](2,2,3,3-tetramethylcyclopropyl)methanone (XLR11), N-(1-
adamantyl)-1-pentyl-1H-indazole-3-carboxamide (AKB48), amphetamine (for 
sale), codeine (for conversion), codeine (for sale), fentanyl, 
hydrocodone (for sale), methylphenidate, morphine (for conversion), 
morphine (for sale), oripavine, oxycodone (for sale), oxymorphone (for 
sale), tapentadol, tetrahydrocannabinol, thebaine, and 
phenylpropanolamine (for sale), the DEA has determined that the 
proposed initial 2014 aggregate production quotas and assessment of 
annual needs are sufficient to meet the current 2014 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, the 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. The 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 public need, as 
determined by the DEA. The 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 2014 aggregate 
production quotas for the following Schedule I and II controlled 
substances and the 2014 assessment of annual needs for the List I 
chemicals ephedrine, pseudoephedrine, and phenylpropanolamine, 
expressed in grams of anhydrous acid or base, as follows:

------------------------------------------------------------------------
                                                        Established 2014
               Basic Class--Schedule I                   Quotas (grams)
------------------------------------------------------------------------
(1-Pentyl-1H-indol-3-yl)(2,2,3,3-                                     15
 tetramethylcyclopropyl)methanone (UR-144)...........
[1-(5-fluoro-pentyl)-1H-indol-3-yl](2,2,3,3-                          15
 tetramethylcyclopropyl)methanone (XLR11)............
1-(1-Phenylcyclohexyl)pyrrolidine....................                 10
1-(5-Fluoropentyl)-3-(1-naphthoyl)indole (AM2201)....                 45
1-(5-Fluoropentyl)-3-(2-iodobenzoyl)indole (AM694)...                 45
1-[1-(2-Thienyl)cyclohexyl]piperidine................                 15
1-[2-(4-Morpholinyl)ethyl]-3-(1-naphthoyl)indole (JWH-                45
 200)................................................
1-Butyl-3-(1-naphthoyl)indole (JWH-073)..............                 45
1-Cyclohexylethyl-3-(2-methoxyphenylacetyl)indole (SR-                45
 18 and RCS-8).......................................
1-Hexyl-3-(1-naphthoyl)indole (JWH-019)..............                 45
1-Methyl-4-phenyl-4-propionoxypiperidine.............                  2
1-Pentyl-3-(1-naphthoyl)indole (JWH-018 and AM678)...                 45
1-Pentyl-3-(2-chlorophenylacetyl)indole (JWH-203)....                 45
1-Pentyl-3-(2-methoxyphenylacetyl)indole (JWH-250)...                 45
1-Pentyl-3-(4-chloro-1-naphthoyl)indole (JWH-398)....                 45
1-Pentyl-3-(4-methyl-1-naphthoyl)indole (JWH-122)....                 45
1-Pentyl-3-[(4-methoxy)-benzoyl]indole (SR-19, RCS-4)                 45
1-Pentyl-3-[1-(4-methoxynaphthoyl)]indole (JWH-081)..                 45
2-(2,5-Dimethoxy-4-(n)-propylphenyl)ethanamine (2C-P)                 30
2-(2,5-Dimethoxy-4-ethylphenyl)ethanamine (2C-E).....                 30
2-(2,5-Dimethoxy-4-methylphenyl)ethanamine (2C-D)....                 30
2-(2,5-Dimethoxy-4-nitro-phenyl)ethanamine (2C-N)....                 30
2-(2,5-Dimethoxyphenyl)ethanamine (2C-H).............                 30
2-(4-Chloro-2,5-dimethoxyphenyl)ethanamine (2C-C)....                 30
2-(4-Iodo-2,5-dimethoxyphenyl)ethanamine (2C-I)......                 30
2,5-Dimethoxy-4-ethylamphetamine (DOET)..............                 25
2,5-Dimethoxy-4-n-propylthiophenethylamine...........                 25
2,5-Dimethoxyamphetamine.............................                 25
2-[4-(Ethylthio)-2,5-dimethoxyphenyl]ethanamine (2C-T-                30
 2)..................................................
2-[4-(Isopropylthio)-2,5-dimethoxyphenyl]ethanamine                   30
 (2C-T-4)............................................
3,4,5-Trimethoxyamphetamine..........................                 25
3,4-Methylenedioxyamphetamine (MDA)..................                 55
3,4-Methylenedioxymethamphetamine (MDMA).............                 50
3,4-Methylenedioxy-N-ethylamphetamine (MDEA).........                 40
3,4-Methylenedioxy-N-methylcathinone (methylone).....                 50
3,4-Methylenedioxypyrovalerone (MDPV)................                 35
3-Methylfentanyl.....................................                  2
3-Methylthiofentanyl.................................                  2
4-Bromo-2,5-dimethoxyamphetamine (DOB)...............                 25
4-Bromo-2,5-dimethoxyphenethylamine (2-CB)...........                 25
4-Methoxyamphetamine.................................                100
4-Methyl-2,5-dimethoxyamphetamine (DOM)..............                 25
4-Methylaminorex.....................................                 25

[[Page 55101]]

 
4-Methyl-N-methylcathinone (mephedrone)..............                 45
5-(1,1-Dimethylheptyl)-2-[(1R,3S)-3-                                  68
 hydroxycyclohexyl]-phenol...........................
5-(1,1-Dimethyloctyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-                53
 phenol (cannabicyclohexanol or CP-47, 497 C8-
 homolog)............................................
5-Methoxy-3,4-methylenedioxyamphetamine..............                 25
5-Methoxy-N,N-diisopropyltryptamine..................                 25
5-Methoxy-N,N-dimethyltryptamine.....................                 25
Acetyl-alpha-methylfentanyl..........................                  2
Acetyldihydrocodeine.................................                  2
Acetylmethadol.......................................                  2
Allylprodine.........................................                  2
Alphacetylmethadol...................................                  2
Alpha-ethyltryptamine................................                 25
Alphameprodine.......................................                  2
Alphamethadol........................................                  2
Alpha-methylfentanyl.................................                  2
Alpha-methylthiofentanyl.............................                  2
Alpha-methyltryptamine (AMT).........................                 25
Aminorex.............................................                 25
Benzylmorphine.......................................                  2
Betacetylmethadol....................................                  2
Beta-hydroxy-3-methylfentanyl........................                  2
Beta-hydroxyfentanyl.................................                  2
Betameprodine........................................                  2
Betaprodine..........................................                  2
Bufotenine...........................................                  3
Cathinone............................................                 70
Codeine Methylbromide................................                  5
Codeine-N-oxide......................................                200
Desomorphine.........................................                  5
Diethyltryptamine....................................                 25
Difenoxin............................................                 50
Dihydromorphine......................................          3,990,000
Dimethyltryptamine...................................                 35
Dipipanone...........................................                  5
Fenethylline.........................................                  5
Gamma-hydroxybutyric acid............................         70,250,000
Heroin...............................................                 25
Hydromorphinol.......................................                  2
Hydroxypethidine.....................................                  2
Ibogaine.............................................                  5
Lysergic acid diethylamide (LSD).....................                 35
Marihuana............................................             21,000
Mescaline............................................                 25
Methaqualone.........................................                 10
Methcathinone........................................                 25
Methyldesorphine.....................................                  2
Methyldihydromorphine................................                  2
Morphine Methylbromide...............................                  5
Morphine Methylsulfonate.............................                  5
Morphine-N-oxide.....................................                175
N-(1-adamantyl)-1-pentyl-1H-indazole-3-carboxamide                    15
 (AKB48).............................................
N-Benzylpiperazine...................................                 25
N,N-Dimethylamphetamine..............................                 25
N-Ethyl-1-phenylcyclohexylamine......................                  5
N-Ethylamphetamine...................................                 24
N-Hydroxy-3,4-methylenedioxyamphetamine..............                 24
Noracymethadol.......................................                  2
Norlevorphanol.......................................                 52
Normethadone.........................................                  2
Normorphine..........................................                 18
Para-fluorofentanyl..................................                  2
Parahexyl............................................                  5
Phenomorphan.........................................                  2
Pholcodine...........................................                  2
Properidine..........................................                  2
Psilocybin...........................................                 30
Psilocyn.............................................                 30
Tetrahydrocannabinols................................            491,000
Thiofentanyl.........................................                  2
Tilidine.............................................                 10
Trimeperidine........................................                  2
------------------------------------------------------------------------


[[Page 55102]]


------------------------------------------------------------------------
                                                        Established 2014
               Basic Class--Schedule II                  Quotas (grams)
------------------------------------------------------------------------
1-Phenylcyclohexylamine..............................                  3
1-Piperdinocyclohexanecarbonitrile (PCC).............                  3
4-Anilino-N-phenethyl-4-piperidine (ANPP)............          2,687,500
Alfentanil...........................................             17,625
Alphaprodine.........................................                  3
Amobarbital..........................................                  9
Amphetamine (for conversion).........................         18,375,000
Amphetamine (for sale)...............................         49,000,000
Carfentanil..........................................                 19
Cocaine..............................................            240,000
Codeine (for conversion).............................         68,750,000
Codeine (for sale)...................................         46,125,000
Dextropropoxyphene...................................                 19
Dihydrocodeine.......................................            100,750
Diphenoxylate........................................            750,000
Ecgonine.............................................            144,000
Ethylmorphine........................................                  3
Fentanyl.............................................          2,108,750
Glutethimide.........................................                  3
Hydrocodone (for sale)...............................         99,625,000
Hydromorphone........................................          6,750,000
Isomethadone.........................................                  5
Levo-alphacetylmethadol (LAAM).......................                  4
Levomethorphan.......................................                195
Levorphanol..........................................              2,000
Lisdexamfetamine.....................................         23,750,000
Meperidine...........................................          6,250,000
Meperidine Intermediate-A............................                  6
Meperidine Intermediate-B............................                 11
Meperidine Intermediate-C............................                  6
Metazocine...........................................                 19
Methadone (for sale).................................         31,875,000
Methadone Intermediate...............................         38,875,000
Methamphetamine......................................          2,811,375
------------------------------------------------------------------------
[1,250,000 grams of levo-desoxyephedrine for use in a non-controlled,
 non-prescription product; 1,500,000 grams for methamphetamine mostly
 for conversion to a schedule III product; and 61,375 grams for
 methamphetamine (for sale)]
------------------------------------------------------------------------
Methylphenidate......................................         96,750,000
Morphine (for conversion)............................         91,250,000
Morphine (for sale)..................................         62,500,000
Nabilone.............................................             30,375
Noroxymorphone (for conversion)......................         17,500,000
Noroxymorphone (for sale)............................          1,462,500
Opium (powder).......................................            112,500
Opium (tincture).....................................            625,000
Oripavine............................................         22,750,000
Oxycodone (for conversion)...........................          9,250,000
Oxycodone (for sale).................................        149,375,000
Oxymorphone (for conversion).........................         25,000,000
Oxymorphone (for sale)...............................          7,750,000
Pentobarbital........................................         35,000,000
Phenazocine..........................................                  6
Phencyclidine........................................                 19
Phenmetrazine........................................                  3
Phenylacetone........................................         67,000,000
Racemethorphan.......................................                  3
Remifentanil.........................................              3,750
Secobarbital.........................................            215,003
Sufentanil...........................................              6,255
Tapentadol...........................................         17,500,000
Thebaine.............................................        145,000,000
------------------------------------------------------------------------


------------------------------------------------------------------------
                                                         Proposed 2014
            Basic Class--List I Chemicals                    Quotas
------------------------------------------------------------------------
Ephedrine (for conversion)...........................          1,000,000
Ephedrine (for sale).................................          3,000,000
Phenylpropanolamine (for conversion).................         44,800,000
Phenylpropanolamine (for sale).......................          5,300,000
Pseudoephedrine (for conversion).....................              5,000
Pseudoephedrine (for sale)...........................        192,000,000
------------------------------------------------------------------------


[[Page 55103]]

    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 2014 aggregate production quotas and 
assessment of annual needs as needed.

    Dated: August 30, 2013.
Thomas M. Harrigan,
Deputy Administrator.
[FR Doc. 2013-21797 Filed 9-6-13; 8:45 am]
BILLING CODE 4410-09-P