[Federal Register Volume 81, Number 193 (Wednesday, October 5, 2016)]
[Notices]
[Pages 69079-69083]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-23988]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-443F]
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 2017
AGENCY: Drug Enforcement Administration, Department of Justice.
ACTION: Final order.
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SUMMARY: This final order establishes the initial 2017 aggregate
production quotas for controlled substances in schedules I and II of
the Controlled Substances Act (CSA) and the assessment of annual needs
for the list I chemicals ephedrine, pseudoephedrine, and
phenylpropanolamine.
DATES: Effective October 5, 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)
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 2017 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
2017 to provide for the estimated medical, scientific, research, and
industrial needs of the United States, lawful export requirements, and
the establishment and maintenance of reserve stocks. These quotas
include imports of ephedrine, pseudoephedrine, and phenylpropanolamine,
but do not include imports of controlled substances for use in
industrial processes.
On July 22, 2016, 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 2017'' was published in the Federal Register.
81 FR 47821. This notice proposed the 2017 aggregate production quotas
for each basic class of controlled substance listed in schedules I and
II and the 2017 assessment of annual needs for the list I chemicals
ephedrine, pseudoephedrine, and phenylpropanolamine. All interested
persons were invited to comment on or object to the proposed aggregate
production quotas and the proposed assessment of annual needs on or
before August 22, 2016.
Comments Received
Thirteen comments were received from five DEA-registered
manufacturers and four non-DEA registered entities within the published
comment period regarding 22 different schedule I and II controlled
substances. The DEA received two comments from two non-DEA registered
entities within the published comment period regarding the proposed
assessment of annual needs for the list I chemical ephedrine (for
sale). Commenters stated that the proposed aggregate production quotas
for acetyl fentanyl, AH-7921, amphetamine (for conversion), amphetamine
(for sale), beta-hydroxythiofentanyl, butyryl fentanyl, cocaine,
codeine (for conversion), codeine (for sale), dihydrocodeine, ecgonine,
hydrocodone (for sale), hydromorphone, levorphanol, lisdexamfetamine,
marihuana, meperidine, methylphenidate, nabilone, opium tincture,
oxycodone (for sale), and sufentanil, as well as, the proposed
assessment of annual needs for ephedrine (for sale) were insufficient
to provide for the estimated medical, scientific, research, and
industrial needs
[[Page 69080]]
of the United States, export requirements, and the establishment and
maintenance of reserve stocks.
The DEA received one comment from a DEA-registrant and three
comments by non-DEA registered entities regarding the proposed removal
of the additional 25% of the estimated medical, scientific, and
research needs for the United States. Two of the commenters requested
that the DEA continue to include the additional 25%, one commenter
requested transparency in the process of setting aggregate production
quotas, and the last commenter agreed with the DEA that the additional
25% should not be included in aggregate production quotas values. The
DEA has considered these comments, as well as the ones for specific
controlled substances and ephedrine (for sale), in establishing the
2017 aggregate production quotas and assessment of annual needs.
Determination of 2017 Aggregate Production Quotas and Assessment of
Annual Needs
In determining the 2017 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 2016 manufacturing quotas, current 2016 sales
and inventories, anticipated 2017 export requirements, industrial use,
and additional applications for 2017 quotas, as well as information on
research and product development requirements. Based on this
information, the DEA has removed the additional 25% from the aggregate
production quotas before determining that adjustments to the proposed
aggregate production quotas for 4-anilino-n-phenethyl-piperidine,
amphetamine (for conversion), amphetamine (for sale), cocaine,
dihydrocodeine, ecgonine, etorphine hydrochloride, hydromorphone,
levorphanol, lysergic acid dimethylamide, nabilone, opium tincture, and
oripavine are warranted. Adjustment to the proposed annual assessment
of needs for ephedrine (for sale) was also determined to be warranted.
This final order reflects those adjustments.
Regarding acetyl fentanyl, AH-7921, beta-hydroxythiofentanyl,
butyryl fentanyl, codeine (for conversion), codeine (for sale),
hydrocodone (for sale), lisdexamfetamine, marihuana, meperidine,
methylphenidate, oxycodone (for sale), and sufentanil, the DEA has
determined that the proposed aggregate production quotas are sufficient
to provide for the 2017 estimated medical, scientific, research, and
industrial needs of the United States, export requirements, and the
establishment and maintenance of reserve stocks. This final order
establishes these aggregate production quotas at the same amounts as
proposed.
In accordance with 21 U.S.C. 826, 21 CFR 1303.11, and 21 CFR
1315.11, the Administrator hereby establishes the 2017 aggregate
production quotas for the following schedule I and II controlled
substances and the 2017 assessment of annual needs for the list I
chemicals ephedrine, pseudoephedrine, and phenylpropanolamine,
expressed in grams of anhydrous acid or base, as follows:
------------------------------------------------------------------------
2017
Basic class Established
quotas (g)
------------------------------------------------------------------------
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)....... 30
1-(5-Fluoropentyl)-3-(2-iodobenzoyl)indole (AM694)...... 30
1-[1-(2-Thienyl)cyclohexyl]piperidine................... 15
1-[2-(4-Morpholinyl)ethyl]-3-(1-naphthoyl)indole (JWH- 35
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)...... 35
1-Pentyl-3-(2-chlorophenylacetyl)indole (JWH-203)....... 30
1-Pentyl-3-(2-methoxyphenylacetyl)indole (JWH-250)...... 30
1-Pentyl-3-(4-chloro-1-naphthoyl)indole (JWH-398)....... 30
1-Pentyl-3-(4-methyl-1-naphthoyl)indole (JWH-122)....... 30
1-Pentyl-3-[(4-methoxy)-benzoyl]indole (SR-19, RCS-4)... 30
1-Pentyl-3-[1-(4-methoxynaphthoyl)]indole (JWH-081)..... 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-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- 5
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
[[Page 69081]]
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........................................ 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]- 50
phenol.................................................
5-(1,1-Dimethyloctyl)-2-[(1R,3S)-3-hydroxycyclohexyl]- 40
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
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
beta-Hydroxythiofentanyl................................ 30
Betacetylmethadol....................................... 2
Betameprodine........................................... 2
Betamethadol............................................ 4
Betaprodine............................................. 2
Bufotenine.............................................. 3
Butylone................................................ 25
Butyryl fentanyl........................................ 30
Cathinone............................................... 24
Codeine methylbromide................................... 5
Codeine-N-oxide......................................... 305
Desomorphine............................................ 25
Diethyltryptamine....................................... 25
Difenoxin............................................... 8,750
Dihydromorphine......................................... 1,566,000
Dimethyltryptamine...................................... 35
Dipipanone.............................................. 5
Fenethylline............................................ 5
gamma-Hydroxybutyric acid............................... 56,200,000
Heroin.................................................. 25
Hydromorphinol.......................................... 2
Hydroxypethidine........................................ 2
Ibogaine................................................ 5
Lysergic acid diethylamide (LSD)........................ 15
Marihuana............................................... 472,000
Mescaline............................................... 25
Methaqualone............................................ 10
Methcathinone........................................... 25
[[Page 69082]]
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 20
(5-fluoro-PB-22; 5F-PB-22).............................
Quinolin-8-yl 1-pentyl-1H-indole-3-carboxylate (PB-22; 20
QUPIC).................................................
Tetrahydrocannabinols................................... 409,000
Thiofentanyl............................................ 2
Tilidine................................................ 25
Trimeperidine........................................... 2
UR-144.................................................. 25
------------------------------------------------------------------------
Schedule II
------------------------------------------------------------------------
1-Phenylcyclohexylamine................................. 4
1-Piperidinocyclohexanecarbonitrile..................... 4
4-Anilino-N-phenethyl-4-piperidine (ANPP)............... 1,750,000
Alfentanil.............................................. 4,200
Alphaprodine............................................ 2
Amobarbital............................................. 20,100
Amphetamine (for conversion)............................ 12,000,000
Amphetamine (for sale).................................. 42,400,000
Carfentanil............................................. 10
Cocaine................................................. 103,400
Codeine (for conversion)................................ 40,000,000
Codeine (for sale)...................................... 45,000,000
Dextropropoxyphene...................................... 15
Dihydrocodeine.......................................... 281,100
Dihydroetorphine........................................ 2
Diphenoxylate (for conversion).......................... 15,000
Diphenoxylate (for sale)................................ 820,000
Ecgonine................................................ 99,000
Ethylmorphine........................................... 2
Etorphine hydrochloride................................. 32
Fentanyl................................................ 1,750,000
Glutethimide............................................ 2
Hydrocodone (for conversion)............................ 122,000
Hydrocodone (for sale).................................. 58,410,000
Hydromorphone........................................... 5,140,800
Isomethadone............................................ 4
Levo-alphacetylmethadol (LAAM).......................... 3
Levomethorphan.......................................... 10
Levorphanol............................................. 8,300
Lisdexamfetamine........................................ 19,000,000
Meperidine.............................................. 3,706,000
Meperidine Intermediate-A............................... 5
Meperidine Intermediate-B............................... 9
Meperidine Intermediate-C............................... 5
Metazocine.............................................. 15
[[Page 69083]]
Methadone (for sale).................................... 23,700,000
Methadone Intermediate.................................. 25,600,000
Methamphetamine......................................... 1,539,100
------------------------------------------------------------------------
[900,000 grams of levo-desoxyephedrine for use in a non-controlled, non-
prescription product; 600,000 grams for methamphetamine mostly for
conversion to a schedule III product; and 39,100 grams for
methamphetamine (for sale)]
------------------------------------------------------------------------
Methylphenidate......................................... 73,000,000
Morphine (for conversion)............................... 27,300,000
Morphine (for sale)..................................... 41,000,000
Nabilone................................................ 19,000
Noroxymorphone (for conversion)......................... 17,700,000
Noroxymorphone (for sale)............................... 400,000
Opium (powder).......................................... 90,000
Opium (tincture)........................................ 907,200
Oripavine............................................... 22,000,000
Oxycodone (for conversion).............................. 2,610,000
Oxycodone (for sale).................................... 108,510,000
Oxymorphone (for conversion)............................ 22,300,000
Oxymorphone (for sale).................................. 4,200,000
Pentobarbital........................................... 27,500,000
Phenazocine............................................. 5
Phencyclidine........................................... 20
Phenmetrazine........................................... 2
Phenylacetone........................................... 20
Racemethorphan.......................................... 2
Racemorphan............................................. 2
Remifentanil............................................ 3,000
Secobarbital............................................ 172,002
Sufentanil.............................................. 4,000
Tapentadol.............................................. 21,000,000
Thebaine................................................ 100,000,000
------------------------------------------------------------------------
List I Chemicals
------------------------------------------------------------------------
Ephedrine (for conversion).............................. 50,000
Ephedrine (for sale).................................... 5,360,000
Phenylpropanolamine (for conversion).................... 15,000,000
Phenylpropanolamine (for sale).......................... 8,500,000
Pseudoephedrine (for conversion)........................ 40
Pseudoephedrine (for sale).............................. 200,000,000
------------------------------------------------------------------------
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 2017 aggregate production quotas and
assessment of annual needs as needed.
Dated: September 26, 2016.
Chuck Rosenberg,
Acting Administrator.
[FR Doc. 2016-23988 Filed 10-4-16; 8:45 am]
BILLING CODE 4410-09-P