Established Aggregate Production Quotas for Schedule I and II Controlled Substances and Assessment of Annual Needs for the List I Chemicals Ephedrine, Pseudoephedrine, and Phenylpropanolamine for 2016, 60400-60405 [2015-25373]

Agencies

• Drug Enforcement Administration
• Department of Justice

[Federal Register Volume 80, Number 193 (Tuesday, October 6, 2015)]
[Notices]
[Pages 60400-60405]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-25373]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-420F]


Established Aggregate Production Quotas for Schedule I and II 
Controlled Substances and Assessment of Annual Needs for the List I 
Chemicals Ephedrine, Pseudoephedrine, and Phenylpropanolamine for 2016

AGENCY: Drug Enforcement Administration, Department of Justice.

ACTION: Final order.

-----------------------------------------------------------------------

SUMMARY: This final order establishes the initial 2016 aggregate 
production quotas for controlled substances in schedules I and II of 
the Controlled Substances Act (CSA) and the assessment of annual needs 
for the list I chemicals ephedrine, pseudoephedrine, and 
phenylpropanolamine.

DATES: Effective October 6, 2015.

FOR FURTHER INFORMATION CONTACT: John R. Scherbenske, Office of 
Diversion Control, Drug Enforcement Administration, 8701 Morrissette 
Drive, Springfield, VA 22152, Telephone: (202) 598-6812.

SUPPLEMENTARY INFORMATION:

Legal Authority

    The Drug Enforcement Administration (DEA) implements and enforces 
titles II and III of the Comprehensive Drug Abuse Prevention and 
Control Act of 1970, as amended. Titles II and III are referred to as 
the ``Controlled Substances Act'' and the ``Controlled Substances 
Import and Export Act,'' respectively, and are collectively referred to 
as the ``Controlled Substances Act'' or the ``CSA'' for the purpose of 
this action. 21

[[Page 60401]]

U.S.C. 801-971. The DEA publishes the implementing regulations for 
these statutes in title 21 of the Code of Federal Regulations (CFR), 
chapter II. The CSA and its implementing regulations are designed to 
prevent, detect, and eliminate the diversion of controlled substances 
and listed chemicals into the illicit market while ensuring an adequate 
supply is available for the legitimate medical, scientific, research, 
and industrial needs of the United States. Controlled substances have 
the potential for abuse and dependence and are controlled to protect 
the public health and safety.
    Section 306 of the Controlled Substances Act (CSA), 21 U.S.C. 826, 
requires the Attorney General to determine the total quantity and 
establish production quotas for each basic class of controlled 
substance in schedules I and II and for ephedrine, pseudoephedrine, and 
phenylpropanolamine to be manufactured each calendar year to provide 
for the estimated medical, scientific, research, and industrial needs 
of the United States, for lawful export requirements, and for the 
establishment and maintenance of reserve stocks. This responsibility 
has been delegated to the Administrator of the DEA through 28 CFR 
0.100(b).

Background

    The 2016 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 that may be manufactured in the United States in 
2016 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 17, 2015, 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 2016'' was published in 
the Federal Register. 80 FR 42540. This notice proposed the 2016 
aggregate production quotas for each basic class of controlled 
substance listed in schedules I and II and the 2016 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 17, 2015.

Comments Received

    Twenty comments were received from four DEA-registered 
manufacturers within the published comment period regarding 17 
different schedule I and II controlled substances. The DEA did not 
receive any comments regarding the proposed assessment of annual needs 
for the list I chemicals ephedrine, pseudoephedrine, and 
phenylpropanolamine. Commenters stated that the proposed aggregate 
production quotas for [1-(5-fluoropentyl)-1H-indazol-3-yl](naphthalen-
1-yl)methanone (THJ-2201), amphetamine (for sale), codeine (for sale), 
gamma hydroxybutric acid, levorphanol, marihuana, methylphenidate, N-
(1-Amino-3,3-dimethyl-1-oxobutan-2-yl)-1-pentyl-1H-indazole-3-
carboxamide (ADB-PINACA), N-(1-Amino-3-methyl-1-oxobutan-2-yl)-1-(4-
fluorobenzyl)-1H-indazole-3-carboxamide (AB-FUBINACA), N-(1-Amino-3-
methyl-1-oxobutan-2-yl)-1-(cyclohexylmethyl)-1H-indazole-3-carboxamide 
(AB-CHMINACA), N-(1-Amino-3-methyl-1-oxobutan-2-yl)-1-pentyl-1H-
indazole-3-carboxamide (AB-PINACA), N-(1-phenethylpiperidin-4-yl)-N-
phenylacetamide (acetyl fentanyl), nabilone, oxymorphone (for 
conversion), oxymorphone (for sale), Quinolin-8-yl 1-(5-fluoropentyl)-
1H-indole-3-carboxylate (5-Flouro-PB-22), and Quinolin-8-yl 1-pentyl-
1H-indole-3-carboxylate (PB-22) 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.

Determination of 2016 Aggregate Production Quotas and Assessment of 
Annual Needs

    In determining the 2016 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 2015 manufacturing quotas, current 2015 sales 
and inventories, anticipated 2016 export requirements, industrial use, 
additional applications for 2016 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 for codeine (for sale), hydromorphone, 
marihuana, methylphenidate, and N-(1-phenethylpiperidin-4-yl)-N-
phenylacetamide (acetyl fentanyl) are warranted. This final order 
reflects those adjustments.
    Regarding [1-(5-fluoropentyl)-1H-indazol-3-yl](naphthalen-1-
yl)methanone (THJ-2201), amphetamine (for sale), gamma hydroxybutric 
acid, levorphanol, N-(1-Amino-3,3-dimethyl-1-oxobutan-2-yl)-1-pentyl-
1H-indazole-3-carboxamide (ADB-PINACA), N-(1-Amino-3-methyl-1-oxobutan-
2-yl)-1-(4-fluorobenzyl)-1H-indazole-3-carboxamide (AB-FUBINACA), N-(1-
Amino-3-methyl-1-oxobutan-2-yl)-1-(cyclohexylmethyl)-1H-indazole-3-
carboxamide (AB-CHMINACA), N-(1-Amino-3-methyl-1-oxobutan-2-yl)-1-
pentyl-1H-indazole-3-carboxamide (AB-PINACA), nabilone, oxymorphone 
(for conversion), oxymorphone (for sale), Quinolin-8-yl 1-(5-
fluoropentyl)-1H-indole-3-carboxylate (5-Flouro-PB-22), and Quinolin-8-
yl 1-pentyl-1H-indole-3-carboxylate (PB-22), the DEA has determined 
that the proposed aggregate production quotas are sufficient to provide 
for the 2016 estimated medical, scientific, research, and industrial 
needs of the United States, export requirements, and the establishment 
and maintenance of reserve stocks. This final order establishes these 
aggregate production quotas at the same amounts as proposed.
    As described in the previously published notice proposing the 2016 
aggregate production quotas and assessment of annual needs, the DEA has 
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 has included in all 
established 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 will reflect these 
included amounts. This action will not affect the ability of

[[Page 60402]]

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 results in the 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 Administrator hereby establishes the 2016 aggregate 
production quotas for the following schedule I and II controlled 
substances and the 2016 assessment of annual needs for the list I 
chemicals ephedrine, pseudoephedrine, and phenylpropanolamine, 
expressed in grams of anhydrous acid or base, as follows:

------------------------------------------------------------------------
                                                        Established 2016
                     Basic class                           quotas (g)
------------------------------------------------------------------------
                               Schedule I
------------------------------------------------------------------------
(1-Pentyl-1H-indol-3-yl)(2,2,3,3-                                     25
 tetramethylcyclopropyl)methanone (UR-144)...........
[1-(5-fluoropentyl)-1H-indazol-3-yl](naphthalen-1-                    15
 yl)methanone (THJ-2201).............................
[1-(5-Fluoro-pentyl)-1H-indol-3-yl](2,2,3,3-                          25
 tetramethylcyclopropyl)methanone (XLR11)............
1-(1,3-Benzodioxol-5-yl)-2-(methylamino)butan-1-one                   25
 (butylone)..........................................
1-(1,3-Benzodioxol-5-yl)-2-(methylamino)pentan-1-one                  25
 (pentylone).........................................
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-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-Dimethoxy-4-n-propylphenyl)ethanamine (2C-P)..                 30
2-(2,5-Dimethoxyphenyl)ethanamine (2C-H).............                 30
2-(4-Bromo-2,5-dimethoxyphenyl)-N-(2-                                 25
 methoxybenzyl)ethanamine (25B-NBOMe; 2C-B-NBOMe;
 25B; Cimbi-36)......................................
2-(4-Chloro-2,5-dimethoxyphenyl)ethanamine (2C-C)....                 30
2-(4-Chloro-2,5-dimethoxyphenyl)-N-(2-                                25
 methoxybenzyl)ethanamine (25C-NBOMe; 2C-C-NBOMe;
 25C; Cimbi-82)......................................
2-(4-Iodo-2,5-dimethoxyphenyl)ethanamine (2C-I)......                 30
2-(4-Iodo-2,5-dimethoxyphenyl)-N-(2-                                  15
 methoxybenzyl)ethanamine (25I-NBOMe; 2C-I-NBOMe;
 25I; Cimbi-5).......................................
2-(Methylamino)-1-phenylpentan-1-one (pentedrone)....                 25
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-Fluoro-N-methylcathinone (3-FMC)...................                 25
3-Methylfentanyl.....................................                  2
3-Methylthiofentanyl.................................                  2
4-Bromo-2,5-dimethoxyamphetamine (DOB)...............                 25
4-Bromo-2,5-dimethoxyphenethylamine (2-CB)...........                 25
4-Fluoro-N-methylcathinone (4-FMC)...................                 25
4-Methoxyamphetamine.................................                150
4-Methyl-2,5-dimethoxyamphetamine (DOM)..............                 25
4-Methylaminorex.....................................                 25
4-Methyl-N-ethylcathinone (4-MEC)....................                 25
4-Methyl-N-methylcathinone (mephedrone)..............                 45
4-Methyl-[alpha]-pyrrolidinopropiophenone (4-MePPP)..                 25
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

[[Page 60403]]

 
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
alpha-Pyrrolidinobutiophenone ([alpha]-PBP)..........                 25
alpha-Pyrrolidinopentiophenone ([alpha]-PVP).........                 25
Aminorex.............................................                 25
Benzylmorphine.......................................                  2
Betacetylmethadol....................................                  2
beta-Hydroxy-3-methylfentanyl........................                  2
beta-Hydroxyfentanyl.................................                  2
Betameprodine........................................                  2
Betamethadol.........................................                  4
Betaprodine..........................................                  2
Bufotenine...........................................                  3
Cathinone............................................                 70
Codeine methylbromide................................                  5
Codeine-N-oxide......................................                305
Desomorphine.........................................                 25
Diethyltryptamine....................................                 25
Difenoxin............................................             11,000
Dihydromorphine......................................          3,000,000
Dimethyltryptamine...................................                 35
Dipipanone...........................................                  5
Fenethylline.........................................                  5
gamma-Hydroxybutyric acid............................         70,250,000
Heroin...............................................                 50
Hydromorphinol.......................................                  2
Hydroxypethidine.....................................                  2
Ibogaine.............................................                  5
Lysergic acid diethylamide (LSD).....................                 40
Marihuana............................................            658,000
Mescaline............................................                 25
Methaqualone.........................................                 10
Methcathinone........................................                 25
Methyldesorphine.....................................                  5
Methyldihydromorphine................................                  2
Morphine methylbromide...............................                  5
Morphine methylsulfonate.............................                  5
Morphine-N-oxide.....................................                350
N-(1-Adamantyl)-1-pentyl-1H-indazole-3-carboxamide                    25
 (AKB48).............................................
N-(1-Amino-3,3-dimethyl-1-oxobutan-2-yl)-1-pentyl-1H-                 50
 indazole-3-carboxamide (ADB-PINACA).................
N-(1-Amino-3-methyl-1-oxobutan-2-yl)-1-(4-                            50
 fluorobenzyl)-1H-indazole-3-carboxamide (AB-
 FUBINACA)...........................................
N-(1-Amino-3-methyl-1-oxobutan-2-yl)-1-                               15
 (cyclohexylmethyl)-1H-indazole-3-carboxamide (AB-
 CHMINACA)...........................................
N-(1-Amino-3-methyl-1-oxobutan-2-yl)-1-pentyl-1H-                     15
 indazole-3-carboxamide (AB-PINACA)..................
N-(1-phenethylpiperidin-4-yl)-N-phenylacetamide                      100
 (acetyl fentanyl)...................................
N,N-Dimethylamphetamine..............................                 25
Naphthylpyrovalerone (naphyrone).....................                 25
N-Benzylpiperazine...................................                 25
N-Ethyl-1-phenylcyclohexylamine......................                  5
N-Ethylamphetamine...................................                 24
N-Hydroxy-3,4-methylenedioxyamphetamine..............                 24
Noracymethadol.......................................                  2
Norlevorphanol.......................................                 52
Normethadone.........................................                  2
Normorphine..........................................                 40
Para-fluorofentanyl..................................                  5
Parahexyl............................................                  5
Phenomorphan.........................................                  2
Pholcodine...........................................                  5
Psilocybin...........................................                 30
Psilocyn.............................................                 50
Quinolin-8-yl 1-(5-fluoropentyl)-1H-indole-3-                         50
 carboxylate (5-fluoro-PB-22; 5F-PB-22)..............
Quinolin-8-yl 1-pentyl-1H-indole-3-carboxylate (PB-                   50
 22; QUPIC)..........................................
Tetrahydrocannabinols................................            511,250
Thiofentanyl.........................................                  2
Tilidine.............................................                 25

[[Page 60404]]

 
Trimeperidine........................................                  2
------------------------------------------------------------------------
                               Schedule II
------------------------------------------------------------------------
1-Phenylcyclohexylamine..............................                  5
1-Piperidinocyclohexanecarbonitrile..................                  5
4-Anilino-N-phenethyl-4-piperidine (ANPP)............          2,950,000
Alfentanil...........................................             17,750
Alphaprodine.........................................                  3
Amobarbital..........................................             25,125
Amphetamine (for conversion).........................         15,000,000
Amphetamine (for sale)...............................         39,705,000
Carfentanil..........................................                 19
Cocaine..............................................            200,000
Codeine (for conversion).............................         50,000,000
Codeine (for sale)...................................         63,900,000
Dextropropoxyphene...................................                 45
Dihydrocodeine.......................................            226,375
Dihydroetorphine.....................................                  3
Diphenoxylate (for conversion).......................             31,250
Diphenoxylate (for sale).............................          1,337,500
Ecgonine.............................................            125,000
Ethylmorphine........................................                  3
Etorphine hydrochloride..............................                  3
Fentanyl.............................................          2,300,000
Glutethimide.........................................                  3
Hydrocodone (for conversion).........................            235,000
Hydrocodone (for sale)...............................         88,500,000
Hydromorphone........................................          8,250,000
Isomethadone.........................................                  5
Levo-alphacetylmethadol (LAAM).......................                  4
Levomethorphan.......................................                 30
Levorphanol..........................................              7,125
Lisdexamfetamine.....................................         29,750,000
Meperidine...........................................          5,450,000
Meperidine Intermediate-A............................                  6
Meperidine Intermediate-B............................                 11
Meperidine Intermediate-C............................                  6
Metazocine...........................................                 19
Methadone (for sale).................................         31,875,000
Methadone Intermediate...............................         34,375,000
Methamphetamine......................................          2,061,375
------------------------------------------------------------------------
  [1,250,000 grams of levo-desoxyephedrine for use in a non-controlled,
 non-prescription product; 750,000 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.............................................             18,750
Noroxymorphone (for conversion)......................         17,500,000
Noroxymorphone (for sale)............................          1,475,000
Opium (powder).......................................            112,500
Opium (tincture).....................................            687,500
Oripavine............................................         30,000,000
Oxycodone (for conversion)...........................          6,250,000
Oxycodone (for sale).................................        139,150,000
Oxymorphone (for conversion).........................         29,000,000
Oxymorphone (for sale)...............................          7,750,000
Pentobarbital........................................         38,125,000
Phenazocine..........................................                  6
Phencyclidine........................................                 50
Phenmetrazine........................................                  3
Phenylacetone........................................                 50
Racemethorphan.......................................                  3
Racemorphan..........................................                  3
Remifentanil.........................................              3,750
Secobarbital.........................................            215,003
Sufentanil...........................................              6,255
Tapentadol...........................................         25,500,000
Thebaine.............................................        125,000,000
------------------------------------------------------------------------

[[Page 60405]]

 
                            List I Chemicals
------------------------------------------------------------------------
Ephedrine (for conversion)...........................            100,000
Ephedrine (for sale).................................          4,000,000
Phenylpropanolamine (for conversion).................         22,400,000
Phenylpropanolamine (for sale).......................          8,500,000
Pseudoephedrine (for conversion).....................              7,000
Pseudoephedrine (for sale)...........................        224,500,000
------------------------------------------------------------------------

    The 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. In accordance with 21 CFR 1303.13 and 21 
CFR 1315.13, upon consideration of the relevant factors, the 
Administrator may adjust the 2016 aggregate production quotas and 
assessment of annual needs as needed.

    Dated: September 30, 2015.
Chuck Rosenberg,
Acting Administrator.
[FR Doc. 2015-25373 Filed 10-5-15; 8:45 am]
 BILLING CODE 4410-09-P