[Federal Register Volume 79, Number 173 (Monday, September 8, 2014)]
[Notices]
[Pages 53216-53220]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-21280]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-393]
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 2015
AGENCY: Drug Enforcement Administration (DEA), Department of Justice
(DOJ).
ACTION: Notice.
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SUMMARY: This notice establishes the initial 2015 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 date: Effective September 8, 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:
Legal Authority
The Drug Enforcement Administration (DEA) implements and enforces
titles II and III of the Comprehensive Drug Abuse Prevention and
Control Act of 1970, as amended. Titles II and III are referred to as
the ``Controlled Substances Act'' and the ``Controlled Substances
Import and Export Act,'' respectively, and are collectively referred to
as the ``Controlled Substances Act'' or the ``CSA'' for the purpose of
this action. 21 U.S.C. 801-971. The DEA publishes the implementing
regulations for these statutes in title 21 of the Code of Federal
Regulations (CFR), parts 1300 to 1321. The CSA and its implementing
regulations are designed to prevent, detect, and eliminate the
diversion of controlled substances and listed chemicals into the
illicit market while providing for the legitimate medical, scientific,
research, and industrial needs of the United States. Controlled
substances have the potential for abuse and dependence and are
controlled to protect the public health and safety.
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 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.
Background
The 2015 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 to be manufactured in the United States in 2015 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 2, 2014, a notice titled, ``Proposed Aggregate Production
Quotas for Schedule I and II Controlled Substances and Proposed
Assessment of Annual Needs for the List I Chemicals Ephedrine,
Pseudoephedrine, and Phenylpropanolamine for 2015'' was published in
the Federal Register. 79 FR 37772. This notice proposed the 2015
aggregate production quotas for each basic class of controlled
substance listed in schedules I and II and the 2015 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 1, 2014.
Comments Received
Five comments were received from DEA-registered manufacturers
within the published comment period, offering comments on a total of 32
schedule I and II controlled substances. None of the respondents
commented on the list I chemicals ephedrine, pseudoephedrine, and
phenylpropanolamine. Commenters stated that the proposed aggregate
production quotas for 1-(1,3-Benzodioxol-5-yl)-2-(methylamino) butan-1-
one (butylone), 1-(1,3-Benzodioxol-5-yl)-2-(methylamino) pentan-1-one
(pentylone), 2-(4-Bromo-2,5-dimethoxyphenyl)-N-(2-
methoxybenzyl)ethanamine (25B-NBOMe), 2-(4-Chloro-2,5-dimethoxyphenyl)-
N-(2-methoxybenzyl)ethanamine (25C-NBOMe), 2-(4-Iodo-2,5-
dimethoxyphenyl)-N-(2-methoxybenzyl)ethanamine (25I-NBOMe), 2-
(Methylamino)-1-phenylpentan-1-one (pentedrone), 3-Fluoro-N-
methylcathinone (3-FMC), 4-Fluoro-N-methylcathinone (4-FMC), 4-Anilino-
N-phenethyl-4-piperidine (ANPP), 4-Methyl-N-ethylcathinone (4-MEC), 4-
Methyl-[alpha]-pyrrolidinopropiophenone (4-MePPP), alpha-
Pyrrolidinobutiophenone ([alpha]-PBP), alpha-Pyrrolidinopentiophenone
([alpha]-PVP), amphetamine (for sale), codeine (for sale),
dihydrocodeine, diphenoxylate, fentanyl, hydrocodone (for sale),
hydromorphone, levorphanol, marihuana, morphine (for conversion), N-(1-
Amino-3,3-dimethyl-1-oxobutan-2-yl)-1-pentyl-1H-indazole-3-carboxamide
(ADB-PINACA), N-(1-Amino-3-methyl-1-oxobutan-2-yl)-1-(4-fluorobenzyl)-
1H-indazole-3-carboxamide (AB-FUBINACA), naphthylpyrovalerone
(naphyrone), oripavine, oxycodone (for conversion), oxymorphone (for
conversion), oxymorphone (for sale), Quinolin-8-yl 1-(5-fluoropentyl)-
1H-indole-3-carboxylate (5-Flouro-PB-22), and Quinolin-8-yl 1-pentyl-
1H-indole-3-carboxylate (PB-22) 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.
Determination of 2015 Aggregate Production Quotas and Assessment of
Annual Needs
In determining the 2015 aggregate production quotas and assessment
of annual needs, the DEA has taken into consideration the above
comments along with the factors set forth at 21 CFR 1303.11 and 21 CFR
1315.11, in accordance with 21 U.S.C. 826 (a), and other relevant
factors, including the consideration of 2014 manufacturing quotas,
current 2014 sales and inventories, 2015 export requirements,
industrial use, additional applications for quotas, as well as
information on research and product development requirements. Based on
this information, the DEA has determined
[[Page 53217]]
that adjustments to the proposed aggregate production quotas and
assessment of annual needs for alfentanil, cocaine, codeine-N-oxide,
codeine (for sale), dihydrocodeine, fentanyl, hydromorphone,
levorphanol, marihuana, oripavine, oxymorphone (for conversion), and
ephedrine (for sale) are warranted. This notice reflects those
adjustments.
Regarding 1-(1,3-Benzodioxol-5-yl)-2-(methylamino)butan-1-one
(butylone), 1-(1,3-Benzodioxol-5-yl)-2-(methylamino)pentan-1-one
(pentylone), 2-(4-Bromo-2,5-dimethoxyphenyl)-N-(2-
methoxybenzyl)ethanamine (25B-NBOMe), 2-(4-Chloro-2,5-dimethoxyphenyl)-
N-(2-methoxybenzyl)ethanamine (25C-NBOMe), 2-(4-Iodo-2,5-
dimethoxyphenyl)-N-(2-methoxybenzyl)ethanamine (25I-NBOMe), 2-
(Methylamino)-1-phenylpentan-1-one (pentedrone), 3-Fluoro-N-
methylcathinone (3-FMC), 4-Fluoro-N-methylcathinone (4-FMC), 4-Anilino-
N-phenethyl-4-piperidine (ANPP), 4-Methyl-N-ethylcathinone (4-MEC), 4-
Methyl-[alpha]-pyrrolidinopropiophenone (4-MePPP), alpha-
Pyrrolidinobutiophenone ([alpha]-PBP), alpha-Pyrrolidinopentiophenone
([alpha]-PVP), amphetamine (for sale), dihydrocodeine, fentanyl,
hydromorphone, levorphanol, marihuana, N-(1-Amino-3,3-dimethyl-1-
oxobutan-2-yl)-1-pentyl-1H-indazole-3-carboxamide (ADB-PINACA), N-(1-
Amino-3-methyl-1-oxobutan-2-yl)-1-(4-fluorobenzyl)-1H-indazole-3-
carboxamide (AB-FUBINACA), naphthylpyrovalerone (naphyrone), oxycodone
(for conversion), oxymorphone (for sale), Quinolin-8-yl 1-(5-
fluoropentyl)-1H-indole-3-carboxylate (5-Flouro-PB-22), and Quinolin-8-
yl 1-pentyl-1H-indole-3-carboxylate (PB-22), the DEA has determined
that the proposed aggregate production quotas are sufficient to provide
for the 2015 estimated medical, scientific, research, and industrial
needs of the United States, export requirements, and the establishment
and maintenance of reserve stocks. This notice finalizes these
aggregate production quotas at the same amounts as proposed.
As described in the previously published notice proposing the 2015
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
established 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 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.
In accordance with 21 U.S.C. 826, 21 CFR 1303.11, and 21 CFR
1315.11, the Deputy Administrator hereby establishes the 2015 aggregate
production quotas for the following schedule I and II controlled
substances and the 2015 assessment of annual needs for the list I
chemicals ephedrine, pseudoephedrine, and phenylpropanolamine,
expressed in grams of anhydrous acid or base, as follows:
------------------------------------------------------------------------
Established 2015
Basic class quotas (g)
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Schedule I
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(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 45
(JWH-200)..........................................
1-Butyl-3-(1-naphthoyl)indole (JWH-073)............. 45
1-Cyclohexylethyl-3-(2-methoxyphenylacetyl)indole 45
(SR-18 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- 45
4).................................................
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
[[Page 53218]]
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- 30
T-2)...............................................
2-[4-(Isopropylthio)-2,5-dimethoxyphenyl]ethanamine 30
(2C-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- 68
hydroxycyclohexyl]-phenol..........................
5-(1,1-Dimethyloctyl)-2-[(1R,3S)-3- 53
hydroxycyclohexyl]-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
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
Betamethadol........................................ 4
Betaprodine......................................... 2
Bufotenine.......................................... 3
Cathinone........................................... 70
Codeine methylbromide............................... 5
Codeine-N-oxide..................................... 305
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........................................... 125,000
Mescaline........................................... 25
Methaqualone........................................ 10
Methcathinone....................................... 25
Methyldesorphine.................................... 5
[[Page 53219]]
Methyldihydromorphine............................... 2
Morphine methylbromide.............................. 5
Morphine methylsulfonate............................ 5
Morphine-N-oxide.................................... 350
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- 15
fluorobenzyl)-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
Phenomorphan........................................ 2
Psilocybin.......................................... 30
Psilocyn............................................ 30
Quinolin-8-yl 1-(5-fluoropentyl)-1H-indole-3- 15
carboxylate (5-fluoro-PB-22; 5F-PB-22).............
Quinolin-8-yl 1-pentyl-1H-indole-3-carboxylate (PB- 15
22; QUPIC).........................................
Tetrahydrocannabinols............................... 497,500
Thiofentanyl........................................ 2
Tilidine............................................ 10
Trimeperidine....................................... 2
------------------------------------------------------------------------
Schedule II
------------------------------------------------------------------------
1-Phenylcyclohexylamine............................. 5
1-Piperidinocyclohexanecarbonitrile................. 5
4-Anilino-N-phenethyl-4-piperidine (ANPP)........... 2,687,500
Alfentanil.......................................... 17,750
Alphaprodine........................................ 3
Amobarbital......................................... 25,125
Amphetamine (for conversion)........................ 21,875,000
Amphetamine (for sale).............................. 37,500,000
Carfentanil......................................... 19
Cocaine............................................. 275,000
Codeine (for conversion)............................ 50,000,000
Codeine (for sale).................................. 49,500,000
Dextropropoxyphene.................................. 19
Dihydrocodeine...................................... 226,375
Diphenoxylate....................................... 1,337,500
Ecgonine............................................ 174,375
Ethylmorphine....................................... 3
Fentanyl............................................ 2,150,000
Glutethimide........................................ 3
Hydrocodone (for conversion)........................ 137,500
Hydrocodone (for sale).............................. 99,625,000
Hydromorphone....................................... 7,000,000
Isomethadone........................................ 5
Levo-alphacetylmethadol (LAAM)...................... 4
Levomethorphan...................................... 5
Levorphanol......................................... 7,125
Lisdexamfetamine.................................... 29,750,000
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.............................. 34,375,000
Methamphetamine..................................... 2,061,375
------------------------------------------------------------------------
[1,250,000 grams of levo-desoxyephedrine for use in a non-controlled,
non-prescription product; 750,000 grams for methamphetamine mostly for
conversion to a schedule III product; and 61,375 grams for
methamphetamine (for sale)]
------------------------------------------------------------------------
Methylphenidate..................................... 83,750,000
Morphine (for conversion)........................... 91,250,000
Morphine (for sale)................................. 62,500,000
Nabilone............................................ 18,750
Noroxymorphone (for conversion)..................... 17,500,000
[[Page 53220]]
Noroxymorphone (for sale)........................... 1,475,000
Opium (powder)...................................... 112,500
Opium (tincture).................................... 687,500
Oripavine........................................... 35,000,000
Oxycodone (for conversion).......................... 8,350,000
Oxycodone (for sale)................................ 137,500,000
Oxymorphone (for conversion)........................ 29,000,000
Oxymorphone (for sale).............................. 7,750,000
Pentobarbital....................................... 35,000,000
Phenazocine......................................... 6
Phencyclidine....................................... 19
Phenmetrazine....................................... 3
Phenylacetone....................................... 9,375,000
Racemethorphan...................................... 3
Remifentanil........................................ 3,750
Secobarbital........................................ 215,003
Sufentanil.......................................... 6,255
Tapentadol.......................................... 12,500,000
Thebaine............................................ 125,000,000
------------------------------------------------------------------------
List I Chemicals
------------------------------------------------------------------------
Ephedrine (for conversion).......................... 1,000,000
Ephedrine (for sale)................................ 4,000,000
Phenylpropanolamine (for conversion)................ 44,800,000
Phenylpropanolamine (for sale)...................... 8,500,000
Pseudoephedrine (for conversion).................... 7,000
Pseudoephedrine (for sale).......................... 224,500,000
------------------------------------------------------------------------
The Deputy 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 Deputy Administrator may adjust the 2015 aggregate production
quotas and assessment of annual needs as needed.
Dated: September 2, 2014.
Thomas M. Harrigan,
Deputy Administrator.
[FR Doc. 2014-21280 Filed 9-5-14; 8:45 am]
BILLING CODE 4410-09-P