[Federal Register Volume 81, Number 206 (Tuesday, October 25, 2016)]
[Notices]
[Pages 73421-73426]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-25696]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-420F]


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 2016

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

ACTION: Final order.

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

SUMMARY: This final order establishes the final adjusted 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: This order is effective October 25, 2016.

FOR FURTHER INFORMATION CONTACT: Michael J. Lewis, Diversion Control 
Division, Drug Enforcement Administration, 8701 Morrissette Drive, 
Springfield, VA 22152, Telephone: (202) 598-6812.

SUPPLEMENTARY INFORMATION:

Legal Authority

    Section 306 of the Controlled Substances Act (CSA) (21 U.S.C. 826),

[[Page 73422]]

requires the Attorney General to establish aggregate production quotas 
for each basic class of controlled substances listed in schedules I and 
II and for the list I chemicals ephedrine, pseudoephedrine, and 
phenylpropanolamine. The Attorney General has delegated this function 
to the Administrator of the DEA pursuant to 28 CFR 0.100.

Background

    The DEA published the 2016 established aggregate production quotas 
for controlled substances in schedules I and II and for the assessment 
of annual needs for the list I chemicals ephedrine, pseudoephedrine, 
and phenylpropanolamine in the Federal Register on October 6, 2015. 80 
FR 60400. This notice stated that the Administrator would adjust, as 
needed, the established aggregate production quotas in 2016 in 
accordance with 21 CFR 1303.13 and 21 CFR 1315.13. The 2016 proposed 
adjusted 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 22, 2016, (81 FR 
47829) in consideration of the outlined criteria. All interested 
persons were invited to comment on or object to the proposed adjusted 
aggregate production quotas and assessment of annual needs on or before 
August 22, 2016.

Comments Received

    Four DEA-registered entities submitted timely comments regarding a 
total of six schedule I and II controlled substances. Comments received 
proposed that the aggregate production quotas for amphetamine (for 
sale), etorphine hydrochloride, methadone, methadone intermediate, 
nabilone, and phencyclidine 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 received one comment from a non-
DEA registered entity requesting the reduction of oxycodone (for sale) 
to pre-2013 levels. The DEA received one comment from a DEA registrant 
regarding the proposed removal of the additional 25% of the estimated 
medical, scientific, and research needs of the United States for the 
calendar year 2017 published in the Federal Register on July 22, 2016 
(81 FR 47821).
    The DEA received one comment from a DEA-registered entity and two 
comments from non-DEA registered entities for the proposed adjustments 
to the 2016 assessment of annual needs for ephedrine, pseudoephedrine, 
and phenylpropanolamine. Comments received proposed that the annual 
assessment of needs for ephedrine (for sale) and pseudoephedrine (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.

Analysis for Final Adjusted 2016 Aggregate Production Quotas and 
Assessment of Annual Needs

    In determining the final adjusted 2016 aggregate production quotas 
and assessment of annual needs, the DEA has taken into consideration 
the above comments along with the factors set forth in 21 CFR 1303.13 
and 21 CFR 1315.13 in accordance with 21 U.S.C. 826(a), and other 
relevant factors including the 2015 year-end inventories, initial 2016 
manufacturing and import quotas, 2016 export requirements, actual and 
projected 2016 sales, research and product development requirements, 
and additional applications received. Based on all of the above, the 
Administrator has determined that the proposed adjusted 2016 aggregate 
production quotas and assessment of annual needs for amphetamine (for 
sale), etorphine hydrochloride, dextropropoxyphene, levorphanol, 
nabilone, noroxymorphone (for sale), phencyclidine, and secobarbital 
required additional consideration, and hereby further adjusts the 2016 
aggregate production quotas and assessment of annual needs for these 
substances. This final order reflects those adjustments.
    Regarding ephedrine (for sale), methadone, methadone intermediate, 
oxycodone (for sale), and pseudoephedrine (for sale) the Administrator 
hereby determines that the proposed adjusted 2016 aggregate production 
quotas and assessment of annual needs for these substances and list I 
chemicals as published on July 22, 2016, (81 FR 47829) are sufficient 
to meet the current 2016 estimated medical, scientific, research, and 
industrial needs of the United States and to provide for adequate 
reserve stock. This final order establishes these aggregate production 
quotas at the same amounts as proposed.
    As described in the previously published notice establishing 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. 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 final 
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 
resulting final aggregate production quotas will 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 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.
    Pursuant to the above, the Administrator hereby finalizes 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:

[[Page 73423]]



 
------------------------------------------------------------------------
                                                           Revised 2016
                                                              quotas
                       Basic class                       ---------------
                                                                (g)
------------------------------------------------------------------------
                    Temporarily Scheduled Substances
------------------------------------------------------------------------
beta-Hydroxythiofentanyl................................              30
Butyryl fentanyl........................................              30
------------------------------------------------------------------------
                               Schedule I
------------------------------------------------------------------------
[1-(5-fluoropentyl)-1H-indazol-3-yl](naphthalen-1-                    15
 yl)methanone (THJ-2201)................................
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-Benzylpiperazine......................................              25
1-Butyl-3-(1-naphthoyl)indole (JWH-073).................              45
1-Cyclohexylethyl-3-(2-methoxyphenylacetyl)indole (SR-18              45
 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)...............................................
2,5-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-2)              30
2-[4-(Isopropylthio)-2,5-dimethoxyphenyl]ethanamine (2C-              30
 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-FMC; 3-Fluoro-N-methylcathinone.......................              25
3-Methylfentanyl........................................               2
3-Methylthiofentanyl....................................               2
4-Bromo-2,5-dimethoxyamphetamine (DOB)..................              25
4-Bromo-2,5-dimethoxyphenethylamine (2-CB)..............              25
4-FMC; Flephedrone......................................              25
4-Methoxyamphetamine....................................             150
4-Methyl-2,5-dimethoxyamphetamine (DOM).................              25
4-Methylaminorex........................................              25
4-MEC; 4-Methyl-N-ethylcathinone........................              25
4-Methyl-N-methylcathinone (mephedrone).................              45
4-Methyl-[alpha]-pyrrolidinopropiophenone (4-MePPP).....              25
5-(1,1-Dimethylheptyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-               68
 phenol.................................................
5-(1,1-Dimethyloctyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-                53
 phenol (cannabicyclohexanol or CP-47,497 C8-homolog)...
5-Fluoro-UR144, XLR11...................................              25
5-Methoxy-3,4-methylenedioxyamphetamine.................              25
5-Methoxy-N,N-diisopropyltryptamine.....................              25
5-Methoxy-N,N-dimethyltryptamine........................              25
AB-PINACA...............................................              15
Acetyl-alpha-methylfentanyl.............................               2
Acetyldihydrocodeine....................................               2
Acetylmethadol..........................................               2
AH-7921.................................................              30

[[Page 73424]]

 
Allylprodine............................................               2
alpha-Ethyltryptamine...................................              25
alpha-Methylfentanyl....................................               2
alpha-Methylthiofentanyl................................               2
alpha-Methyltryptamine (AMT)............................              25
alpha-Pyrrolidinobutiophenone ([alpha]-PBP).............              25
alpha-Pyrrolidinopentiophenone ([alpha]-PVP)............              25
Alphacetylmethadol......................................               2
Alphameprodine..........................................               2
Alphamethadol...........................................               2
Aminorex................................................              25
APINCA, AKB48...........................................              25
Benzylmorphine..........................................               2
beta-Hydroxy-3-methylfentanyl...........................               2
beta-Hydroxyfentanyl....................................               2
Betacetylmethadol.......................................               2
Betameprodine...........................................               2
Betamethadol............................................               4
Betaprodine.............................................               2
Bufotenine..............................................               3
Butylone................................................              25
Cathinone...............................................              30
Codeine methylbromide...................................               5
Codeine-N-oxide.........................................             305
Desomorphine............................................              25
Diethyltryptamine.......................................              25
Difenoxin...............................................          11,000
Dihydromorphine.........................................       2,000,000
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,N-Dimethylamphetamine.................................              25
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-fluorobenzyl)-              50
 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-phenethylpiperidin-4-yl)-N-phenylacetamide (acetyl              100
 fentanyl)..............................................
N-Ethyl-1-phenylcyclohexylamine.........................               5
N-Ethylamphetamine......................................              24
N-Hydroxy-3,4-methylenedioxyamphetamine.................              24
Naphyrone...............................................              25
Noracymethadol..........................................               2
Norlevorphanol..........................................              52
Normethadone............................................               2
Normorphine.............................................              40
Para-fluorofentanyl.....................................               5
Parahexyl...............................................               5
Pentedrone..............................................              25
Pentylone...............................................              25
Phenomorphan............................................               2
Pholcodine..............................................               5
Psilocybin..............................................              30
Psilocyn................................................              50
Quinolin-8-yl 1-(5-fluoropentyl)-1H-indole-3-carboxylate              25
 (5-fluoro-PB-22; 5F-PB-22).............................
Quinolin-8-yl 1-pentyl-1H-indole-3-carboxylate (PB-22;                25
 QUPIC).................................................

[[Page 73425]]

 
Tetrahydrocannabinols...................................         511,250
Thiofentanyl............................................               2
Tilidine................................................              25
Trimeperidine...........................................               2
UR-144..................................................              25
------------------------------------------------------------------------
                               Schedule II
------------------------------------------------------------------------
1-Phenylcyclohexylamine.................................               5
1-Piperidinocyclohexanecarbonitrile.....................               5
4-Anilino-N-phenethyl-4-piperidine (ANPP)...............       2,250,000
Alfentanil..............................................          17,750
Alphaprodine............................................               3
Amobarbital.............................................          25,125
Amphetamine (for conversion)............................      15,000,000
Amphetamine (for sale)..................................      50,000,000
Carfentanil.............................................              19
Cocaine.................................................         200,000
Codeine (for conversion)................................      50,000,000
Codeine (for sale)......................................      63,900,000
Dextropropoxyphene......................................              55
Dihydrocodeine..........................................         226,375
Dihydroetorphine........................................               3
Diphenoxylate (for conversion)..........................          18,750
Diphenoxylate (for sale)................................       1,337,500
Ecgonine................................................         125,000
Ethylmorphine...........................................               5
Etorphine hydrochloride.................................              40
Fentanyl................................................       2,300,000
Glutethimide............................................               3
Hydrocodone (for conversion)............................         177,500
Hydrocodone (for sale)..................................      86,000,000
Hydromorphone...........................................       7,000,000
Isomethadone............................................               5
Levo-alphacetylmethadol (LAAM)..........................               4
Levomethorphan..........................................              33
Levorphanol.............................................           9,525
Lisdexamfetamine........................................      23,750,000
Meperidine..............................................       4,632,500
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.........................................      84,375,000
Morphine (for conversion)...............................      91,250,000
Morphine (for sale).....................................      62,500,000
Nabilone................................................          18,875
Noroxymorphone (for conversion).........................      17,500,000
Noroxymorphone (for sale)...............................         875,000
Opium (powder)..........................................         112,500
Opium (tincture)........................................         375,000
Oripavine...............................................      30,000,000
Oxycodone (for conversion)..............................       5,000,000
Oxycodone (for sale)....................................     139,150,000
Oxymorphone (for conversion)............................      25,000,000
Oxymorphone (for sale)..................................       6,250,000
Pentobarbital...........................................      38,125,000
Phenazocine.............................................               6
Phencyclidine...........................................              60
Phenmetrazine...........................................               3
Phenylacetone...........................................              50
Racemethorphan..........................................               5
Racemorphan.............................................               3

[[Page 73426]]

 
Remifentanil............................................           3,750
Secobarbital............................................         243,380
Sufentanil..............................................           6,255
Tapentadol..............................................      25,500,000
Thebaine................................................     125,000,000
------------------------------------------------------------------------
                            List I Chemicals
------------------------------------------------------------------------
Ephedrine (for conversion)..............................          50,000
Ephedrine (for sale)....................................       4,000,000
Phenylpropanolamine (for conversion)....................      15,000,000
Phenylpropanolamine (for sale)..........................       8,500,000
Pseudoephedrine (for conversion)........................              40
Pseudoephedrine (for sale)..............................     200,000,000
------------------------------------------------------------------------

    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: October 19, 2016.
Chuck Rosenberg,
Acting Administrator.
[FR Doc. 2016-25696 Filed 10-24-16; 8:45 am]
 BILLING CODE 4410-09-P