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 2018, 51873-51877 [2017-24306]

Agencies

• Drug Enforcement Administration
• Department of Justice

[Federal Register Volume 82, Number 215 (Wednesday, November 8, 2017)]
[Notices]
[Pages 51873-51877]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-24306]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-471F]


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 2018

AGENCY: Drug Enforcement Administration, Department of Justice.

ACTION: Final order.

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SUMMARY: This final order establishes the initial 2018 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.

APPLICABLE DATE: Applicable November 8, 2017.

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) 
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. The Attorney General has delegated this function 
to the Administrator of the DEA pursuant to 28 CFR 0.100.

Background

    The 2018 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 
2018 to provide for the estimated medical, scientific, research, 
industrial needs of the United States, lawful export requirements, and 
the establishment and maintenance of reserve stocks. These quotas 
include imports of ephedrine, pseudoephedrine, and phenylpropanolamine, 
but do not include imports of controlled substances for use in 
industrial processes.
    On August 7, 2017, a notice titled ``Proposed 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 2018'' was published in the Federal Register. 
82 FR 36830. This notice proposed the 2018 aggregate production quotas 
for each basic class of controlled substance listed in schedules I and 
II and the 2018 assessment of annual needs for the list I chemicals 
ephedrine, pseudoephedrine, and phenylpropanolamine. All interested 
persons were invited to comment on or object to the proposed aggregate 
production quotas and the proposed assessment of annual needs on or 
before September 6, 2017.

Comments Received

    Within the public comment period, the DEA received seventeen 
comments from three DEA-registered manufacturers regarding sixteen 
different schedule I and II controlled substances and one comment from 
a DEA-registered manufacturer regarding the proposed assessment of 
annual needs for the list I chemical phenylpropanolamine (for 
conversion). Commenters stated the proposed aggregate production quotas 
for 4-anilino-n-phenethyl-4-piperadine (ANPP), amphetamine (for 
conversion), codeine (for sale), diphenoxylate, fentanyl, gamma 
hydroxybutyric acid, hydrocodone (for sale), lisdexamfetamine, 
methadone, methadone-intermediate, methylphenidate, morphine (for 
conversion), morphine (for sale), oxycodone (for sale), oxymorphone 
(for sale), sufentanil, as well as the proposed assessment of annual 
needs for phenylpropanolamine (for conversion), 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. These comments were considered in 
setting the final 2018 Aggregate Production Quotas as discussed below.
    In addition to these seventeen comments, the DEA received one 
comment from a DEA-registered manufacturer seeking clarification on 
whether DEA considers manufacturing at outsourcing facilities when 
determining the Aggregate Production Quotas. The DEA notes that it is 
the responsibility of all DEA-registered dosage form manufacturers to 
submit quota applications by April 1, in order for their individual 
business practices to be considered when the DEA proposes the Aggregate 
Production Quota for the following year. 21 CFR 1303.12(b). These quota 
applications and comments with discrete data regarding the quantities 
of the basic classes of schedule I or II controlled substances received 
during the comment period for the proposed Aggregate Production Quotas 
are taken into consideration before establishing the values presented 
in this Final Order. This DEA-registered manufacturer provided no 
quantitative data supporting the position that the proposed quota for 
2018 will adversely impact outsourcing facilities for DEA to consider. 
The DEA also received one hundred five comments that expressed concern 
that DEA's proposed reduction of opioids by twenty percent would 
adversely impact the availability of pain relieving prescription drugs 
for people with chronic pain. These comments were general in nature, 
and raised issues of specific medical illnesses and medical treatment, 
and therefore are outside of the scope of this Final Order for 2018. As 
a result, these one hundred and six comments did not provide new 
discrete data for consideration, and do not impact the original 
analysis involved in establishing the 2018 aggregate production quotas.

Determination of 2018 Aggregate Production Quotas and Assessment of 
Annual Needs

    In determining the 2018 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 1303.11 and 21 CFR 
1315.11, in accordance with 21 U.S.C. 826(a), and other relevant 
factors, including the 2017 manufacturing quotas, current 2017 sales 
and inventories, anticipated 2018 export requirements, industrial use, 
additional applications for 2018 quotas, as well as information on 
research and product development requirements. Based on all of the 
above, the Administrator is adjusting the 2018 aggregate production 
quotas for 2-(4-bromo-2,5-dimethoxyphenyl)-n-(2-methoxybenzyl) 
ethanamine, 3,4,5-trimethoxy amphetamine, 4-bromo-2,5-dimethoxy-
amphetamine, acryl fentanyl, alfentanil, amobarbital, methylphenidate, 
and nabilone, are warranted. Adjustment to the proposed assessment of 
annual needs for

[[Page 51874]]

pseudoephedrine (for sale) was also determined to be warranted. This 
final order reflects those adjustments.
    Regarding 4-anilino-n-phenethyl-4-piperadine (ANPP), amphetamine 
(for conversion), codeine (for sale), diphenoxylate, fentanyl, gamma 
hydroxybutyric acid, hydrocodone (for sale), lisdexamfetamine, 
methadone, methadone-intermediate, morphine (for conversion), morphine 
(for sale), oxycodone (for sale), oxymorphone (for sale), sufentanil, 
and phenylpropanolamine (for conversion), the DEA has determined the 
proposed aggregate production quotas and assessment of annual needs are 
sufficient to provide for the 2018 estimated medical, scientific, 
research, industrial needs of the United States, export requirements, 
and the establishment and maintenance of reserve stocks. This final 
order establishes these aggregate production quotas and assessment of 
annual needs at the same amounts as proposed.
    In accordance with 21 U.S.C. 826, 21 CFR 1303.11, and 21 CFR 
1315.11, the Administrator hereby establishes the 2018 aggregate 
production quotas for the following schedule I and II controlled 
substances and the 2018 assessment of annual needs for the list I 
chemicals ephedrine, pseudoephedrine, and phenylpropanolamine, 
expressed in grams of anhydrous acid or base, as follows:

------------------------------------------------------------------------
                                                               2018
                       Basic class                          Established
                                                            quotas (g)
------------------------------------------------------------------------
                    Temporarily Scheduled Substances
------------------------------------------------------------------------
Acryl fentanyl..........................................              25
------------------------------------------------------------------------
                               Schedule I
------------------------------------------------------------------------
1-(1-Phenylcyclohexyl)pyrrolidine.......................              10
1-(5-Fluoropentyl)-3-(1-naphthoyl)indole (AM2201).......              30
1-(5-Fluoropentyl)-3-(2-iodobenzoyl)indole (AM694)......              30
1-[1-(2-Thienyl)cyclohexyl]piperidine...................              15
1-Benzylpiperazine......................................              25
1-Methyl-4-phenyl-4-propionoxypiperidine................               2
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-                                 30
 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-                                  30
 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.............................              30
3,4-Methylenedioxyamphetamine (MDA).....................              55
3,4-Methylenedioxymethamphetamine (MDMA)................              50
3,4-Methylenedioxy-N-ethylamphetamine (MDEA)............              40
3,4-Methylenedioxy-N-methylcathinone (methylone)........              40
3,4-Methylenedioxypyrovalerone (MDPV)...................              35
3-FMC; 3-Fluoro-N-methylcathinone.......................              25
3-Methylfentanyl........................................              30
3-Methylthiofentanyl....................................              30
4-Bromo-2,5-dimethoxyamphetamine (DOB)..................              30
4-Bromo-2,5-dimethoxyphenethylamine (2-CB)..............              25
4-Fluoroisobutyryl fentanyl.............................              30
4-FMC; Flephedrone......................................              25
4-MEC; 4-Methyl-N-ethylcathinone........................              25
4-Methoxyamphetamine....................................             150
4-Methyl-2,5-dimethoxyamphetamine (DOM).................              25
4-Methylaminorex........................................              25
4-Methyl-N-methylcathinone (mephedrone).................              45
4-Methyl-[alpha]-pyrrolidinopropiophenone (4-MePPP).....              25
5-(1,1-Dimethylheptyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-               50
 phenol.................................................
5-(1,1-Dimethyloctyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-                40
 phenol (cannabicyclohexanol or CP-47,497 C8-homolog)...
5F-ADB; 5F-MDMB-PINACA (methyl 2-(1-(5-fluoropentyl)-1H-              30
 indazole-3-carboxamido)-3,3-dimethylbutanoate).........
5F-AMB (methyl 2-(1-(5-fluoropentyl)-1H-indazole-3-                   30
 carboxamido)-3-methylbutanoate)........................
5F-APINACA; 5F-AKB48 (N-(adamantan-1-yl)-1-(5-                        30
 fluoropentyl)-1H-indazole-3-carboxamide)...............
5-Fluoro-PB-22; 5F-PB-22................................              20
5-Fluoro-UR144, XLR11 ([1-(5-fluoro-pentyl)-1Hindol-3-                25
 yl](2,2,3,3-tetramethylcyclopropyl)methanone...........
5-Methoxy-3,4-methylenedioxyamphetamine.................              25
5-Methoxy-N,N-diisopropyltryptamine.....................              25
5-Methoxy-N,N-dimethyltryptamine........................              25

[[Page 51875]]

 
AB-CHMINACA.............................................              30
AB-FUBINACA.............................................              50
AB-PINACA...............................................              30
ADB-FUBINACA (N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-             30
 (4-fluorobenzyl)-1H-indazole-3-carboxamide)............
Acetyl Fentanyl.........................................             100
Acetyl-alpha-methylfentanyl.............................              30
Acetyldihydrocodeine....................................              30
Acetylmethadol..........................................               2
Acryl Fentanyl..........................................              25
ADB-PINACA (N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-               50
 pentyl-1H-indazole-3-carboxamide)......................
AH-7921.................................................              30
Allylprodine............................................               2
Alphacetylmethadol......................................               2
alpha-Ethyltryptamine...................................              25
Alphameprodine..........................................               2
Alphamethadol...........................................               2
alpha-Methylfentanyl....................................              30
alpha-Methylthiofentanyl................................              30
alpha-Methyltryptamine (AMT)............................              25
alpha-Pyrrolidinobutiophenone ([alpha]-PBP).............              25
alpha-Pyrrolidinopentiophenone ([alpha]-PVP)............              25
Aminorex................................................              25
APINCA, AKB48 (N-(1-adamantyl)-1-pentyl-1H-indazole-3-                25
 carboxamide)...........................................
Benzylmorphine..........................................              30
Betacetylmethadol.......................................               2
beta-Hydroxy-3-methylfentanyl...........................              30
beta-Hydroxyfentanyl....................................              30
beta-Hydroxythiofentanyl................................              30
Betameprodine...........................................               2
Betamethadol............................................               4
Betaprodine.............................................               2
Bufotenine..............................................               3
Butylone................................................              25
Butyryl fentanyl........................................              30
Cathinone...............................................              24
Codeine methylbromide...................................              30
Codeine-N-oxide.........................................             192
Desomorphine............................................              25
Diethyltryptamine.......................................              25
Difenoxin...............................................           8,225
Dihydromorphine.........................................       1,000,160
Dimethyltryptamine......................................              35
Dipipanone..............................................               5
Etorphine...............................................              30
Fenethylline............................................              30
Furanyl fentanyl........................................              30
gamma-Hydroxybutyric acid...............................      37,130,000
Heroin..................................................              45
Hydromorphinol..........................................              40
Hydroxypethidine........................................               2
Ibogaine................................................              30
JWH-018 and AM678 (1-Pentyl-3-(1-naphthoyl)indole)......              35
JWH-019 (1-Hexyl-3-(1-naphthoyl)indole).................              45
JWH-073 (1-Butyl-3-(1-naphthoyl)indole).................              45
JWH-081 (1-Pentyl-3-[1-(4-methoxynaphthoyl)]indole).....              30
JWH-122 (1-Pentyl-3-(4-methyl-1-naphthoyl)indole).......              30
JWH-200 (1-[2-(4-Morpholinyl)ethyl]-3-(1-                             35
 naphthoyl)indole)......................................
JWH-203 (1-Pentyl-3-(2-chlorophenylacetyl)indole).......              30
JWH-250 (1-Pentyl-3-(2-methoxyphenylacetyl)indole)......              30
JWH-398 (1-Pentyl-3-(4-chloro-1-naphthoyl)indole).......              30
Lysergic acid diethylamide (LSD)........................              40
MAB-CHMINACA; ADB-CHMINACA (N-(1-amino-3,3-dimethyl-1-                30
 oxobutan-2-yl)-1-(cyclohexylmethyl)-1H-indazole-3-
 carboxamide)...........................................
MDMB-CHMICA; MMB-CHMINACA(methyl 2-(1-(cyclohexylmethyl)-             30
 1H-indole-3-carboxamido)-3,3-dimethylbutanoate)........
MDMB-FUBINACA (methyl 2-(1-(4-fluorobenzyl)-1H-indazole-              30
 3-carboxamido)-3,3-dimethylbutanoate)..................
Marihuana...............................................         443,680
Mecloqualone............................................              30
Mescaline...............................................              25
Methaqualone............................................              60
Methcathinone...........................................              25
Methyldesorphine........................................               5

[[Page 51876]]

 
Methyldihydromorphine...................................               2
Morphine methylbromide..................................               5
Morphine methylsulfonate................................               5
Morphine-N-oxide........................................             150
N,N-Dimethylamphetamine.................................              25
Naphyrone...............................................              25
N-Ethyl-1-phenylcyclohexylamine.........................               5
N-Ethylamphetamine......................................              24
N-Hydroxy-3,4-methylenedioxyamphetamine.................              24
Noracymethadol..........................................               2
Norlevorphanol..........................................              55
Normethadone............................................               2
Normorphine.............................................              40
Para-fluorofentanyl.....................................              25
Parahexyl...............................................               5
PB-22; QUPIC............................................              20
Pentedrone..............................................              25
Pentylone...............................................              25
Phenomorphan............................................               2
Pholcodine..............................................               5
Psilocybin..............................................              30
Psilocyn................................................              50
SR-18 and RCS-8 (1-Cyclohexylethyl-3-(2-                              45
 methoxyphenylacetyl)indole)............................
SR-19 and RCS-4 (1-Pentyl-3-[(4-methoxy)-benzoyl]indole)              30
Tetrahydrocannabinols...................................         384,460
Thiofentanyl............................................              25
THJ-2201 ( [1-(5-fluoropentyl)-1H-indazol-3-                          30
 yl](naphthalen-1-yl)methanone).........................
Tilidine................................................              25
Trimeperidine...........................................               2
UR-144 (1-pentyl-1H-indol-3-yl)(2,2,3,3-                              25
 tetramethylcyclopropyl)methanone.......................
U-47700.................................................              30
------------------------------------------------------------------------
                               Schedule II
------------------------------------------------------------------------
1-Phenylcyclohexylamine.................................               4
1-Piperidinocyclohexanecarbonitrile.....................               4
4-Anilino-N-phenethyl-4-piperidine (ANPP)...............       1,342,320
Alfentanil..............................................           6,200
Alphaprodine............................................               2
Amobarbital.............................................          20,100
Amphetamine (for conversion)............................      11,280,000
Amphetamine (for sale)..................................      39,856,000
Carfentanil.............................................              20
Cocaine.................................................          92,120
Codeine (for conversion)................................      15,040,000
Codeine (for sale)......................................      40,015,800
Dextropropoxyphene......................................              35
Dihydrocodeine..........................................         264,140
Dihydroetorphine........................................               2
Diphenoxylate (for conversion)..........................          14,100
Diphenoxylate (for sale)................................         770,800
Ecgonine................................................          88,134
Ethylmorphine...........................................              30
Etorphine hydrochloride.................................              32
Fentanyl................................................       1,342,320
Glutethimide............................................               2
Hydrocodone (for conversion)............................         114,680
Hydrocodone (for sale)..................................      50,348,280
Hydromorphone...........................................       4,547,720
Isomethadone............................................              30
Levo-alphacetylmethadol (LAAM)..........................               5
Levomethorphan..........................................              30
Levorphanol.............................................          12,126
Lisdexamfetamine........................................      17,869,000
Meperidine..............................................       2,717,540
Meperidine Intermediate-A...............................               5
Meperidine Intermediate-B...............................              30
Meperidine Intermediate-C...............................               5
Metazocine..............................................              15
Methadone (for sale)....................................      22,278,000
Methadone Intermediate..................................      24,064,000

[[Page 51877]]

 
Methamphetamine.........................................       1,446,754
------------------------------------------------------------------------
[846,000 grams of levo-desoxyephedrine for use in a non-controlled, non-
   prescription product; 564,000 grams for methamphetamine mostly for
       conversion to a schedule III product; and 36,754 grams for
                       methamphetamine (for sale)]
------------------------------------------------------------------------
Methylphenidate.........................................      64,600,000
Morphine (for conversion)...............................       4,089,000
Morphine (for sale).....................................      33,958,440
Nabilone................................................          31,000
Noroxymorphone (for conversion).........................      14,044,540
Noroxymorphone (for sale)...............................         376,000
Opium (powder)..........................................          84,600
Opium (tincture)........................................         564,000
Oripavine...............................................      24,534,000
Oxycodone (for conversion)..............................       2,453,400
Oxycodone (for sale)....................................      95,692,000
Oxymorphone (for conversion)............................      20,962,000
Oxymorphone (for sale)..................................       3,395,280
Pentobarbital...........................................      25,850,000
Phenazocine.............................................               5
Phencyclidine...........................................              35
Phenmetrazine...........................................              25
Phenylacetone...........................................              40
Racemethorphan..........................................               5
Racemorphan.............................................               5
Remifentanil............................................           2,820
Secobarbital............................................         161,682
Sufentanil..............................................           1,880
Tapentadol..............................................      18,388,280
Thebaine................................................      94,000,000
------------------------------------------------------------------------
                            List I Chemicals
------------------------------------------------------------------------
Ephedrine (for conversion)..............................          47,000
Ephedrine (for sale)....................................       4,136,000
Phenylpropanolamine (for conversion)....................      14,100,000
Phenylpropanolamine (for sale)..........................       7,990,000
Pseudoephedrine (for conversion)........................              40
Pseudoephedrine (for sale)..............................     180,000,000
------------------------------------------------------------------------

    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 2018 aggregate production quotas and 
assessment of annual needs as needed.

    Dated: November 1, 2017.
Robert W. Patterson,
Acting Administrator.
[FR Doc. 2017-24306 Filed 11-7-17; 8:45 am]
 BILLING CODE 4410-09-P