[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)
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Temporarily Scheduled Substances
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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
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[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