[Federal Register Volume 80, Number 179 (Wednesday, September 16, 2015)]
[Notices]
[Pages 55642-55646]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-23199]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-418F]


Final Adjusted 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 2015

AGENCY: Drug Enforcement Administration, Department of Justice.

ACTION: Final order.

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SUMMARY: This final order establishes the final adjusted 2015 aggregate 
production quotas for controlled substances in schedules I and II of 
the Controlled Substances Act and the assessment of annual needs for 
the list I chemicals ephedrine, pseudoephedrine, and 
phenylpropanolamine.

DATES: This order is effective September 16, 2015.

FOR FURTHER INFORMATION CONTACT: John R. Scherbenske, Office of 
Diversion Control, Drug Enforcement Administration, 8701 Morrissette 
Drive, Springfield, Virginia 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. 21 U.S.C. 801-971. 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 purposes of this action. 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 providing 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 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 ephedrine, 
pseudoephedrine, and phenylpropanolamine. This responsibility has been 
delegated to the Administrator of the DEA. 28 CFR 0.100(b).

Background

    The DEA established the initial 2015 aggregate production quotas 
for controlled substances in schedules I and II and the assessment of 
annual needs for the list I chemicals ephedrine, pseudoephedrine, and 
phenylpropanolamine on September 8, 2014. 79 FR 53216. That notice 
stated that the DEA could adjust, as needed, the established aggregate 
production quotas and assessment of annual needs in accordance with 21 
CFR 1303.13 and 21 CFR 1315.13. The proposed adjusted 2015 aggregate 
production quotas for controlled substances in schedules I and II and 
assessment of annual needs for the list I chemicals ephedrine, 
pseudoephedrine, and phenylpropanolamine were subsequently published in 
the Federal Register on July 8, 2015, 80 FR 39156, in consideration of 
the outlined criteria. All interested persons were invited to comment 
on or object to the proposed adjusted 2015 aggregate production quotas 
and assessment of annual needs on or before August 7, 2015.

Analysis for Final Adjusted 2015 Aggregate Production Quotas and 
Assessment of Annual Needs

    Consideration has been given to the criteria outlined in the July 
8, 2015, notice of proposed adjusted aggregate production quotas and 
assessment of annual needs, 80 FR 39156, in accordance with 21 CFR 
1303.13 and 21 CFR 1315.13. Five companies submitted timely comments 
regarding twelve schedule I and II controlled substances. These 
comments suggested that the proposed adjusted aggregate production 
quotas for codeine (for sale), fentanyl, gamma hydroxybutric acid, 
hydrocodone (for sale), methadone, methadone intermediate, 
methylphenidate, morphine (for conversion), oripavine, oxycodone (for 
sale), oxymorphone (for conversion), and oxymorphone (for sale) 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. The DEA did not receive any comments related to the proposal 
not to adjust the 2015 assessment of annual needs for ephedrine, 
pseudoephedrine, and phenylpropanolamine.
    In accordance with 21 CFR 1303.13, the DEA has taken into 
consideration the above comments along with the relevant 2014 year-end 
inventories, initial 2015 manufacturing and import quotas, 2015 export 
requirements, actual and projected 2015 sales, research and product 
development requirements, and the additional quota applications 
received. Upon consideration of the above, the Administrator determined 
that the proposed adjusted 2015 aggregate production quotas for 
dihydroetorphine, ethylmorphine, etorphine HCl, racemethorphan, 
racemorphan, methylphenidate, and oxycodone (for sale) required 
additional consideration and hereby further adjusts the proposed 2015 
aggregate production quotas for these substances. Regarding codeine 
(for sale), fentanyl, gamma hydroxybutric acid, hydrocodone (for sale), 
methadone, methadone intermediate, morphine (for conversion), 
oripavine, oxymorphone (for conversion), and oxymorphone (for sale) the 
Administrator hereby determines that the proposed adjusted 2015 
aggregate production quotas for these substances as published in the 
Federal Register on July 8, 2015, 80 FR 39156, are sufficient to meet 
the current 2015 estimated medical, scientific, research, and 
industrial needs of the United States and to provide for adequate 
reserve stock.
    As described in the previously published notice establishing the 
2015 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 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 
final established aggregate production quotas will reflect these 
included

[[Page 55643]]

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 results 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.
    Pursuant to the above, the Administrator hereby finalizes the 2015 
aggregate production quotas for the following schedule I and II 
controlled substances and the 2015 assessment of annual needs for the 
list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine, 
expressed in grams of anhydrous acid or base, as follows:

------------------------------------------------------------------------
                                                         Final adjusted
                     Basic class                        2015 quotas  (g)
------------------------------------------------------------------------
                               Schedule I
------------------------------------------------------------------------
(1-Pentyl-1H-indol-3-yl)(2,2,3,3-                                     25
 tetramethylcyclopropyl)methanone (UR-144)...........
[1-(5-Fluoro-pentyl)-1H-indol-3-yl](2,2,3,3-                          25
 tetramethylcyclopropyl)methanone (XLR11)............
[1-(5-fluoropentyl)-1H-indazol-3-yl](naphthalen-1-                    15
 yl)methanone (THJ-2201).............................
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-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-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)....                 15
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.................................                100
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 55644]]

 
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......................................          3,990,000
Dimethyltryptamine...................................                 35
Dipipanone...........................................                  5
Fenethylline.........................................                  5
gamma-Hydroxybutyric acid............................         70,250,000
Heroin...............................................                 50
Hydromorphinol.......................................                  2
Hydroxypethidine.....................................                  2
Ibogaine.............................................                  5
Lysergic acid diethylamide (LSD).....................                 35
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-                 25
 indazole-3-carboxamide (ADB-PINACA).................
N-(1-Amino-3-methyl-1-oxobutan-2-yl)-1-(4-                            25
 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,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.............................................                 30
Quinolin-8-yl 1-(5-fluoropentyl)-1H-indole-3-                         25
 carboxylate (5-fluoro-PB-22; 5F-PB-22)..............
Quinolin-8-yl 1-pentyl-1H-indole-3-carboxylate (PB-                   25
 22; QUPIC)..........................................
Tetrahydrocannabinols................................            511,250
Thiofentanyl.........................................                  2
Tilidine.............................................                 25

[[Page 55645]]

 
Trimeperidine........................................                  2
------------------------------------------------------------------------
                               Schedule II
------------------------------------------------------------------------
1-Phenylcyclohexylamine..............................                  5
1-Piperidinocyclohexanecarbonitrile..................                  5
4-Anilino-N-phenethyl-4-piperidine (ANPP)............          2,687,500
Alfentanil...........................................             17,750
Alphaprodine.........................................                  3
Amobarbital..........................................             25,125
Amphetamine (for conversion).........................         21,875,000
Amphetamine (for sale)...............................         37,500,000
Carfentanil..........................................                 19
Cocaine..............................................            275,000
Codeine (for conversion).............................         50,000,000
Codeine (for sale)...................................         63,900,000
Dextropropoxyphene...................................                 45
Dihydrocodeine.......................................            226,375
Dihydroetorphine.....................................                  3
Diphenoxylate (for conversion).......................             75,000
Diphenoxylate (for sale).............................          1,337,500
Ecgonine.............................................            174,375
Ethylmorphine........................................                  5
Etorphine hydrochloride..............................                  3
Fentanyl.............................................          2,300,000
Glutethimide.........................................                  3
Hydrocodone (for conversion).........................            137,500
Hydrocodone (for sale)...............................         99,625,000
Hydromorphone........................................          7,000,000
Isomethadone.........................................                  5
Levo-alphacetylmethadol (LAAM).......................                  4
Levomethorphan.......................................                 30
Levorphanol..........................................              7,125
Lisdexamfetamine.....................................         29,750,000
Meperidine...........................................          6,250,000
Meperidine Intermediate-A............................                  6
Meperidine Intermediate-B............................                 32
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............................................         35,000,000
Oxycodone (for conversion)...........................          8,350,000
Oxycodone (for sale).................................        141,375,000
Oxymorphone (for conversion).........................         29,000,000
Oxymorphone (for sale)...............................          7,750,000
Pentobarbital........................................         35,000,000
Phenazocine..........................................                  6
Phencyclidine........................................                 38
Phenmetrazine........................................                  3
Phenylacetone........................................          9,375,000
Racemethorphan.......................................                  5
Racemorphan..........................................                  3
Remifentanil.........................................              4,200
Secobarbital.........................................            215,003
Sufentanil...........................................              6,255
Tapentadol...........................................         12,500,000
Thebaine.............................................        125,000,000
------------------------------------------------------------------------

[[Page 55646]]

 
                            List I Chemicals
------------------------------------------------------------------------
Ephedrine (for conversion)...........................          1,000,000
Ephedrine (for sale).................................          4,000,000
Phenylpropanolamine (for conversion).................         44,800,000
Phenylpropanolamine (for sale).......................          8,500,000
Pseudoephedrine (for conversion).....................              7,000
Pseudoephedrine (for sale)...........................        224,500,000
------------------------------------------------------------------------

    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: September 10, 2015.
Chuck Rosenberg,
Acting Administrator.
[FR Doc. 2015-23199 Filed 9-15-15; 8:45 am]
 BILLING CODE 4410-09-P