[Federal Register Volume 79, Number 164 (Monday, August 25, 2014)]
[Notices]
[Pages 50700-50704]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-20137]
[[Page 50700]]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-378]
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 2014
AGENCY: Drug Enforcement Administration (DEA), Department of Justice
(DOJ).
ACTION: Notice.
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SUMMARY: This notice establishes the final adjusted 2014 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, as well as the 2014 aggregate production quotas
for three recently temporarily controlled substances.
DATES: Effective August 25, 2014.
FOR FURTHER INFORMATION CONTACT: Imelda Paredes, Executive Assistant,
Office of Diversion Control, Drug Enforcement Administration, 8701
Morrissette Drive, Springfield, VA 22152, Telephone: (202) 598-6812.
SUPPLEMENTARY INFORMATION:
Background
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 ephedrine, pseudoephedrine, and phenylpropanolamine. This
responsibility has been delegated to the Administrator of the Drug
Enforcement Administration (DEA) through 28 CFR 0.100(b). The
Administrator, in turn, has redelegated this function to the Deputy
Administrator, pursuant to 28 CFR pt. 0 subpt. R, App.
The DEA published the 2014 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 (78 FR 55099) on
September 9, 2013. That notice stated that the Deputy Administrator
would adjust, as needed, the established aggregate production quotas in
2014 in accordance with 21 CFR 1303.13 and 21 CFR 1315.13. The 2014
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 June 12, 2014 (79 FR
33780) 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
July 14, 2014.
Analysis for Final Adjusted 2014 Aggregate Production Quotas and
Assessment of Annual Needs
Consideration has been given to the criteria outlined in the June
12, 2014, notice of proposed adjusted aggregate production quotas and
assessment of annual needs, in accordance with 21 CFR 1303.13 and 21
CFR 1315.13. Five companies submitted timely comments regarding a total
of 11 schedule I and II controlled substances. Comments received
proposed that the aggregate production quotas for 4-anilino-phenethyl-
4-piperidine (ANPP), codeine (for sale), diphenoxylate, hydromorphone,
levorphanol, morphine (for conversion), oripavine, oxycodone (for
sale), oxymorphone (for conversion), oxymorphone (for sale), and
tetrahydrocannabinols were insufficient to provide for the estimated
medical, scientific, research, and industrial needs of the United
States, for export requirements, and for the establishment and
maintenance of reserve stocks. The DEA did not receive any comments for
the proposed adjustments to the 2014 assessment of annual needs for
ephedrine, pseudoephedrine, and phenylpropanolamine.
The DEA has taken into consideration the above comments along with
the relevant 2013 year-end inventories, initial 2014 manufacturing and
import quotas, 2014 export requirements, actual and projected 2014
sales, research and product development requirements, and the
additional applications received. Based on all of the above, the Deputy
Administrator has determined that the proposed adjusted 2014 aggregate
production quotas and assessment of annual needs for opium tincture,
oripavine, and ephedrine (for sale) required additional consideration
and hereby further adjusts the 2014 aggregate production quota and
assessment of annual needs for these substances. Regarding 4-anilino-
phenethyl-4-piperidine (ANPP), codeine (for sale), diphenoxylate,
hydromorphone, levorphanol, morphine (for conversion), oxycodone (for
sale), oxymorphone (for conversion), oxymorphone (for sale), and
tetrahydrocannabinols the Deputy Administrator hereby determines that
the proposed adjusted 2014 aggregate production quotas and assessment
of annual needs for these substances and List I chemicals as published
on June 12, 2014 (79 FR 33780) are sufficient to meet the current 2014
estimated medical, scientific, research, and industrial needs of the
United States and to provide for adequate reserve stock.
As described in the previously published notice establishing the
2014 aggregate production quotas and assessment of annual needs, the
DEA has specifically considered that inventory allowances granted to
individual manufacturers may not always result in the availability of
sufficient quantities to maintain an adequate reserve stock pursuant to
21 U.S.C. 826(a), as intended. See 21 CFR 1303.24. This would be
concerning if a natural disaster or other unforeseen event resulted in
substantial disruption to the amount of controlled substances available
to provide for legitimate public need. As such, the DEA has included in
all proposed revised 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 revised established aggregate production quota
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 Deputy Administrator hereby finalizes
the 2014 aggregate production quotas for the following schedule I and
II controlled substances and the 2014 assessment of annual needs for
the List I chemicals ephedrine, pseudoephedrine, and
phenylpropanolamine, expressed in grams of anhydrous acid or base, as
follows:
[[Page 50701]]
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Final adjusted
Basic class 2014 quotas
(g)
------------------------------------------------------------------------
Schedule I
------------------------------------------------------------------------
(1-Pentyl-1H-indol-3-yl)(2,2,3,3- 15
tetramethylcyclopropyl)methanone (UR-144)..............
[1-(5-Fluoro-pentyl)-1H-indol-3-yl](2,2,3,3- 15
tetramethylcyclopropyl)methanone (XLR11)...............
1-(1,3-Benzodioxol-5-yl)-2-(methylamino)butan-1-one 15
(butylone).............................................
1-(1,3-Benzodioxol-5-yl)-2-(methylamino)pentan-1-one 15
(pentylone)............................................
1-(1-Phenylcyclohexyl)pyrrolidine....................... 10
1-(5-Fluoropentyl)-3-(1-naphthoyl)indole (AM2201)....... 45
1-(5-Fluoropentyl)-3-(2-iodobenzoyl)indole (AM694)...... 45
1-[1-(2-Thienyl)cyclohexyl]piperidine................... 15
1-[2-(4-Morpholinyl)ethyl]-3-(1-naphthoyl)indole (JWH- 45
200)...................................................
1-Butyl-3-(1-naphthoyl)indole (JWH-073)................. 45
1-Cyclohexylethyl-3-(2-methoxyphenylacetyl)indole (SR-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-n-propylphenyl)ethanamine (2C-P)..... 30
2-(2,5-Dimethoxy-4-ethylphenyl)ethanamine (2C-E)........ 30
2-(2,5-Dimethoxy-4-methylphenyl)ethanamine (2C-D)....... 30
2-(2,5-Dimethoxy-4-nitro-phenyl)ethanamine (2C-N)....... 30
2-(2,5-Dimethoxyphenyl)ethanamine (2C-H)................ 30
2-(4-Bromo-2,5-dimethoxyphenyl)-N-(2- 15
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- 15
methoxybenzyl)ethanamine (25C-NBOMe; 2C-C-NBOMe; 25C;
Cimbi-82)..............................................
2-(4-Iodo-2,5-dimethoxyphenyl)ethanamine (2C-I)......... 30
2-(4-Iodo-2,5-dimethoxyphenyl)-N-(2- 15
methoxybenzyl)ethanamine (25I-NBOMe; 2C-I-NBOMe; 25I;
Cimbi-5)...............................................
2-(Methylamino)-1-phenylpentan-1-one (pentedrone)....... 15
2,5-Dimethoxy-4-ethylamphetamine (DOET)................. 25
2,5-Dimethoxy-4-n-propylthiophenethylamine.............. 25
2,5-Dimethoxyamphetamine................................ 25
2-[4-(Ethylthio)-2,5-dimethoxyphenyl]ethanamine (2C-T-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-Fluoro-N-methylcathinone (3-FMC)...................... 15
3-Methylfentanyl........................................ 2
3-Methylthiofentanyl.................................... 2
4-Bromo-2,5-dimethoxyamphetamine (DOB).................. 25
4-Bromo-2,5-dimethoxyphenethylamine (2-CB).............. 25
4-Fluoro-N-methylcathinone (4-FMC)...................... 15
4-Methoxyamphetamine.................................... 100
4-Methyl-2,5-dimethoxyamphetamine (DOM)................. 25
4-Methylaminorex........................................ 25
4-Methyl-N-ethylcathinone (4-MEC)....................... 15
4-Methyl-N-methylcathinone (mephedrone)................. 45
4-Methyl-[alpha]-pyrrolidinopropiophenone (4-MePPP)..... 15
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-Methoxy-3,4-methylenedioxyamphetamine................. 25
5-Methoxy-N,N-diisopropyltryptamine..................... 25
5-Methoxy-N,N-dimethyltryptamine........................ 25
Acetyl-alpha-methylfentanyl............................. 2
Acetyldihydrocodeine.................................... 2
Acetylmethadol.......................................... 2
Allylprodine............................................ 2
Alphacetylmethadol...................................... 2
alpha-Ethyltryptamine................................... 25
Alphameprodine.......................................... 2
Alphamethadol........................................... 2
alpha-Methylfentanyl.................................... 2
[[Page 50702]]
alpha-Methylthiofentanyl................................ 2
alpha-Methyltryptamine (AMT)............................ 25
alpha-Pyrrolidinobutiophenone ([alpha]-PBP)............. 15
alpha-Pyrrolidinopentiophenone ([alpha]-PVP)............ 15
Aminorex................................................ 25
Benzylmorphine.......................................... 2
Betacetylmethadol....................................... 2
beta-Hydroxy-3-methylfentanyl........................... 2
beta-Hydroxyfentanyl.................................... 2
Betameprodine........................................... 2
Betaprodine............................................. 2
Bufotenine.............................................. 3
Cathinone............................................... 70
Codeine methylbromide................................... 5
Codeine-N-oxide......................................... 200
Desomorphine............................................ 5
Diethyltryptamine....................................... 25
Difenoxin............................................... 50
Dihydromorphine......................................... 3,990,000
Dimethyltryptamine...................................... 35
Dipipanone.............................................. 5
Fenethylline............................................ 5
gamma-Hydroxybutyric acid............................... 70,250,000
Heroin.................................................. 25
Hydromorphinol.......................................... 2
Hydroxypethidine........................................ 2
Ibogaine................................................ 5
Lysergic acid diethylamide (LSD)........................ 35
Marihuana............................................... 650,000
Mescaline............................................... 25
Methaqualone............................................ 10
Methcathinone........................................... 25
Methyldesorphine........................................ 2
Methyldihydromorphine................................... 2
Morphine methylbromide.................................. 5
Morphine methylsulfonate................................ 5
Morphine-N-oxide........................................ 175
N-(1-Adamantyl)-1-pentyl-1H-indazole-3-carboxamide 15
(AKB48)................................................
N-(1-Amino-3,3-dimethyl-1-oxobutan-2-yl)-1-pentyl-1H- 15
indazole-3-carboxamide (ADB-PINACA)....................
N-(1-Amino-3-methyl-1-oxobutan-2-yl)-1-(4-fluorobenzyl)- 15
1H-indazole-3-carboxamide (AB-FUBINACA)................
N,N-Dimethylamphetamine................................. 25
Naphthylpyrovalerone (naphyrone)........................ 15
N-Benzylpiperazine...................................... 25
N-Ethyl-1-phenylcyclohexylamine......................... 5
N-Ethylamphetamine...................................... 24
N-Hydroxy-3,4-methylenedioxyamphetamine................. 24
Noracymethadol.......................................... 2
Norlevorphanol.......................................... 52
Normethadone............................................ 2
Normorphine............................................. 18
para-Fluorofentanyl..................................... 2
Parahexyl............................................... 5
Phenomorphan............................................ 2
Pholcodine.............................................. 2
Properidine............................................. 2
Psilocybin.............................................. 40
Psilocyn................................................ 50
Quinolin-8-yl 1-(5-fluoropentyl)-1H-indole-3-carboxylate 15
(5-fluoro-PB-22; 5F-PB-22).............................
Quinolin-8-yl 1-pentyl-1H-indole-3-carboxylate (PB-22; 15
QUPIC).................................................
Tetrahydrocannabinols................................... 491,000
Thiofentanyl............................................ 2
Tilidine................................................ 10
Trimeperidine........................................... 2
------------------------------------------------------------------------
Schedule II
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1-Phenylcyclohexylamine................................. 3
1-Piperidinocyclohexanecarbonitrile..................... 3
4-Anilino-N-phenethyl-4-piperidine (ANPP)............... 2,687,500
Alfentanil.............................................. 17,625
Alphaprodine............................................ 3
[[Page 50703]]
Amobarbital............................................. 9
Amphetamine (for conversion)............................ 18,375,000
Amphetamine (for sale).................................. 49,000,000
Carfentanil............................................. 19
Cocaine................................................. 240,000
Codeine (for conversion)................................ 68,750,000
Codeine (for sale)...................................... 46,125,000
Dextropropoxyphene...................................... 19
Dihydrocodeine.......................................... 100,750
Diphenoxylate........................................... 1,288,750
Ecgonine................................................ 174,375
Ethylmorphine........................................... 3
Fentanyl................................................ 2,108,750
Glutethimide............................................ 3
Hydrocodone (for conversion)............................ 137,500
Hydrocodone (for sale).................................. 99,625,000
Hydromorphone........................................... 6,750,000
Isomethadone............................................ 5
Levo-alphacetylmethadol (LAAM).......................... 4
Levomethorphan.......................................... 195
Levorphanol............................................. 4,625
Lisdexamfetamine........................................ 23,750,000
Meperidine.............................................. 6,250,000
Meperidine Intermediate-A............................... 6
Meperidine Intermediate-B............................... 11
Meperidine Intermediate-C............................... 6
Metazocine.............................................. 19
Methadone (for sale).................................... 31,875,000
Methadone Intermediate.................................. 38,875,000
Methamphetamine......................................... 2,811,375
------------------------------------------------------------------------
[1,250,000 grams of levo-desoxyephedrine for use in a non-controlled,
non-prescription product; 1,500,000 grams for methamphetamine mostly
for conversion to a schedule III product; and 61,375 grams for
methamphetamine (for sale)]
------------------------------------------------------------------------
Methylphenidate......................................... 96,750,000
Morphine (for conversion)............................... 91,250,000
Morphine (for sale)..................................... 62,500,000
Nabilone................................................ 30,375
Noroxymorphone (for conversion)......................... 17,500,000
Noroxymorphone (for sale)............................... 1,262,500
Opium (powder).......................................... 112,500
Opium (tincture)........................................ 780,000
Oripavine............................................... 30,625,000
Oxycodone (for conversion).............................. 9,250,000
Oxycodone (for sale).................................... 149,375,000
Oxymorphone (for conversion)............................ 25,000,000
Oxymorphone (for sale).................................. 7,750,000
Pentobarbital........................................... 35,000,000
Phenazocine............................................. 6
Phencyclidine........................................... 19
Phenmetrazine........................................... 3
Phenylacetone........................................... 45,750,000
Racemethorphan.......................................... 3
Remifentanil............................................ 5,875
Secobarbital............................................ 215,003
Sufentanil.............................................. 6,255
Tapentadol.............................................. 17,500,000
Thebaine................................................ 145,000,000
------------------------------------------------------------------------
List I Chemicals
------------------------------------------------------------------------
Ephedrine (for conversion).............................. 1,000,000
Ephedrine (for sale).................................... 4,200,000
Phenylpropanolamine (for conversion).................... 44,800,000
Phenylpropanolamine (for sale).......................... 5,300,000
Pseudoephedrine (for conversion)........................ 5,000
Pseudoephedrine (for sale).............................. 224,500,000
------------------------------------------------------------------------
[[Page 50704]]
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: August 15, 2014.
Thomas M. Harrigan,
Deputy Administrator.
[FR Doc. 2014-20137 Filed 8-22-14; 8:45 am]
BILLING CODE 4410-09-P