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Notice

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 2015

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Information about this document as published in the Federal Register.

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Start Preamble

AGENCY:

Drug Enforcement Administration, Department of Justice.

ACTION:

Final order.

SUMMARY:

This final order establishes the final adjusted 2015 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.

DATES:

This order is effective September 16, 2015.

Start Further Info

FOR FURTHER INFORMATION CONTACT:

John R. Scherbenske, Office of Diversion Control, Drug Enforcement Administration, 8701 Morrissette Drive, Springfield, Virginia 22152; Telephone: (202) 598-6812.

End Further Info End Preamble Start Supplemental Information

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. 21 U.S.C. 801-971. 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 purposes of this action. The DEA publishes the implementing regulations for these statutes in title 21 of the Code of Federal Regulations (CFR), chapter II. 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 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. 28 CFR 0.100(b).

Background

The DEA established the initial 2015 aggregate production quotas for controlled substances in schedules I and II and the assessment of annual needs for the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine on September 8, 2014. 79 FR 53216. That notice stated that the DEA could adjust, as needed, the established aggregate production quotas and assessment of annual needs in accordance with 21 CFR 1303.13 and 21 CFR 1315.13. The proposed adjusted 2015 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 July 8, 2015, 80 FR 39156, in consideration of the outlined criteria. All interested persons were invited to comment on or object to the proposed adjusted 2015 aggregate production quotas and assessment of annual needs on or before August 7, 2015.

Analysis for Final Adjusted 2015 Aggregate Production Quotas and Assessment of Annual Needs

Consideration has been given to the criteria outlined in the July 8, 2015, notice of proposed adjusted aggregate production quotas and assessment of annual needs, 80 FR 39156, in accordance with 21 CFR 1303.13 and 21 CFR 1315.13. Five companies submitted timely comments regarding twelve schedule I and II controlled substances. These comments suggested that the proposed adjusted aggregate production quotas for codeine (for sale), fentanyl, gamma hydroxybutric acid, hydrocodone (for sale), methadone, methadone intermediate, methylphenidate, morphine (for conversion), oripavine, oxycodone (for sale), oxymorphone (for conversion), and oxymorphone (for sale) 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 related to the proposal not to adjust the 2015 assessment of annual needs for ephedrine, pseudoephedrine, and phenylpropanolamine.

In accordance with 21 CFR 1303.13, the DEA has taken into consideration the above comments along with the relevant 2014 year-end inventories, initial 2015 manufacturing and import quotas, 2015 export requirements, actual and projected 2015 sales, research and product development requirements, and the additional quota applications received. Upon consideration of the above, the Administrator determined that the proposed adjusted 2015 aggregate production quotas for dihydroetorphine, ethylmorphine, etorphine HCl, racemethorphan, racemorphan, methylphenidate, and oxycodone (for sale) required additional consideration and hereby further adjusts the proposed 2015 aggregate production quotas for these substances. Regarding codeine (for sale), fentanyl, gamma hydroxybutric acid, hydrocodone (for sale), methadone, methadone intermediate, morphine (for conversion), oripavine, oxymorphone (for conversion), and oxymorphone (for sale) the Administrator hereby determines that the proposed adjusted 2015 aggregate production quotas for these substances as published in the Federal Register on July 8, 2015, 80 FR 39156, are sufficient to meet the current 2015 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 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 included in all 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 final established aggregate production quotas will reflect these included Start Printed Page 55643amounts. 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 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 Administrator hereby finalizes 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:

Basic classFinal adjusted 2015 quotas (g)
Schedule I
(1-Pentyl-1H-indol-3-yl)(2,2,3,3-tetramethylcyclopropyl)methanone (UR-144)25
[1-(5-Fluoro-pentyl)-1H-indol-3-yl](2,2,3,3-tetramethylcyclopropyl)methanone (XLR11)25
[1-(5-fluoropentyl)-1H-indazol-3-yl](naphthalen-1-yl)methanone (THJ-2201)15
1-(1,3-Benzodioxol-5-yl)-2-(methylamino)butan-1-one (butylone)25
1-(1,3-Benzodioxol-5-yl)-2-(methylamino)pentan-1-one (pentylone)25
1-(1-Phenylcyclohexyl)pyrrolidine10
1-(5-Fluoropentyl)-3-(1-naphthoyl)indole (AM2201)45
1-(5-Fluoropentyl)-3-(2-iodobenzoyl)indole (AM694)45
1-[1-(2-Thienyl)cyclohexyl]piperidine15
1-[2-(4-Morpholinyl)ethyl]-3-(1-naphthoyl)indole (JWH-200)45
1-Butyl-3-(1-naphthoyl)indole (JWH-073)45
1-Cyclohexylethyl-3-(2-methoxyphenylacetyl)indole (SR-18 and RCS-8)45
1-Hexyl-3-(1-naphthoyl)indole (JWH-019)45
1-Methyl-4-phenyl-4-propionoxypiperidine2
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-methoxybenzyl)ethanamine (25B-NBOMe; 2C-B-NBOMe; 25B; Cimbi-36)25
2-(4-Chloro-2,5-dimethoxyphenyl)ethanamine (2C-C)30
2-(4-Chloro-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl)ethanamine (25C-NBOMe; 2C-C-NBOMe; 25C; Cimbi-82)25
2-(4-Iodo-2,5-dimethoxyphenyl)ethanamine (2C-I)30
2-(4-Iodo-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl)ethanamine (25I-NBOMe; 2C-I-NBOMe; 25I; Cimbi-5)15
2-(Methylamino)-1-phenylpentan-1-one (pentedrone)15
2,5-Dimethoxy-4-ethylamphetamine (DOET)25
2,5-Dimethoxy-4-n-propylthiophenethylamine25
2,5-Dimethoxyamphetamine25
2-[4-(Ethylthio)-2,5-dimethoxyphenyl]ethanamine (2C-T-2)30
2-[4-(Isopropylthio)-2,5-dimethoxyphenyl]ethanamine (2C-T-4)30
3,4,5-Trimethoxyamphetamine25
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)25
3-Methylfentanyl2
3-Methylthiofentanyl2
4-Bromo-2,5-dimethoxyamphetamine (DOB)25
4-Bromo-2,5-dimethoxyphenethylamine (2-CB)25
4-Fluoro-N-methylcathinone (4-FMC)25
4-Methoxyamphetamine100
4-Methyl-2,5-dimethoxyamphetamine (DOM)25
4-Methylaminorex25
4-Methyl-N-ethylcathinone (4-MEC)25
4-Methyl-N-methylcathinone (mephedrone)45
4-Methyl-α-pyrrolidinopropiophenone (4-MePPP)25
5-(1,1-Dimethylheptyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-phenol68
5-(1,1-Dimethyloctyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-phenol (cannabicyclohexanol or CP-47,497 C8-homolog)53
5-Methoxy-3,4-methylenedioxyamphetamine25
5-Methoxy-N,N-diisopropyltryptamine25
5-Methoxy-N,N-dimethyltryptamine25
Acetyl-alpha-methylfentanyl2
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Acetyldihydrocodeine2
Acetylmethadol2
Allylprodine2
Alphacetylmethadol2
alpha-Ethyltryptamine25
Alphameprodine2
Alphamethadol2
alpha-Methylfentanyl2
alpha-Methylthiofentanyl2
alpha-Methyltryptamine (AMT)25
alpha-Pyrrolidinobutiophenone (α-PBP)25
alpha-Pyrrolidinopentiophenone (α-PVP)25
Aminorex25
Benzylmorphine2
Betacetylmethadol2
beta-Hydroxy-3-methylfentanyl2
beta-Hydroxyfentanyl2
Betameprodine2
Betamethadol4
Betaprodine2
Bufotenine3
Cathinone70
Codeine methylbromide5
Codeine-N-oxide305
Desomorphine25
Diethyltryptamine25
Difenoxin11,000
Dihydromorphine3,990,000
Dimethyltryptamine35
Dipipanone5
Fenethylline5
gamma-Hydroxybutyric acid70,250,000
Heroin50
Hydromorphinol2
Hydroxypethidine2
Ibogaine5
Lysergic acid diethylamide (LSD)35
Marihuana658,000
Mescaline25
Methaqualone10
Methcathinone25
Methyldesorphine5
Methyldihydromorphine2
Morphine methylbromide5
Morphine methylsulfonate5
Morphine-N-oxide350
N-(1-Adamantyl)-1-pentyl-1H-indazole-3-carboxamide (AKB48)25
N-(1-Amino-3,3-dimethyl-1-oxobutan-2-yl)-1-pentyl-1H-indazole-3-carboxamide (ADB-PINACA)25
N-(1-Amino-3-methyl-1-oxobutan-2-yl)-1-(4-fluorobenzyl)-1H-indazole-3-carboxamide (AB-FUBINACA)25
N-(1-Amino-3-methyl-1-oxobutan-2-yl)-1-(cyclohexylmethyl)-1H-indazole-3-carboxamide (AB-CHMINACA)15
N-(1-Amino-3-methyl-1-oxobutan-2-yl)-1-pentyl-1H-indazole-3-carboxamide (AB-PINACA)15
N,N-Dimethylamphetamine25
Naphthylpyrovalerone (naphyrone)25
N-Benzylpiperazine25
N-Ethyl-1-phenylcyclohexylamine5
N-Ethylamphetamine24
N-Hydroxy-3,4-methylenedioxyamphetamine24
Noracymethadol2
Norlevorphanol52
Normethadone2
Normorphine40
Para-fluorofentanyl5
Parahexyl5
Phenomorphan2
Pholcodine5
Psilocybin30
Psilocyn30
Quinolin-8-yl 1-(5-fluoropentyl)-1H-indole-3-carboxylate (5-fluoro-PB-22; 5F-PB-22)25
Quinolin-8-yl 1-pentyl-1H-indole-3-carboxylate (PB-22; QUPIC)25
Tetrahydrocannabinols511,250
Thiofentanyl2
Tilidine25
Start Printed Page 55645
Trimeperidine2
Schedule II
1-Phenylcyclohexylamine5
1-Piperidinocyclohexanecarbonitrile5
4-Anilino-N-phenethyl-4-piperidine (ANPP)2,687,500
Alfentanil17,750
Alphaprodine3
Amobarbital25,125
Amphetamine (for conversion)21,875,000
Amphetamine (for sale)37,500,000
Carfentanil19
Cocaine275,000
Codeine (for conversion)50,000,000
Codeine (for sale)63,900,000
Dextropropoxyphene45
Dihydrocodeine226,375
Dihydroetorphine3
Diphenoxylate (for conversion)75,000
Diphenoxylate (for sale)1,337,500
Ecgonine174,375
Ethylmorphine5
Etorphine hydrochloride3
Fentanyl2,300,000
Glutethimide3
Hydrocodone (for conversion)137,500
Hydrocodone (for sale)99,625,000
Hydromorphone7,000,000
Isomethadone5
Levo-alphacetylmethadol (LAAM)4
Levomethorphan30
Levorphanol7,125
Lisdexamfetamine29,750,000
Meperidine6,250,000
Meperidine Intermediate-A6
Meperidine Intermediate-B32
Meperidine Intermediate-C6
Metazocine19
Methadone (for sale)31,875,000
Methadone Intermediate34,375,000
Methamphetamine2,061,375
[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)]
Methylphenidate96,750,000
Morphine (for conversion)91,250,000
Morphine (for sale)62,500,000
Nabilone18,750
Noroxymorphone (for conversion)17,500,000
Noroxymorphone (for sale)1,475,000
Opium (powder)112,500
Opium (tincture)687,500
Oripavine35,000,000
Oxycodone (for conversion)8,350,000
Oxycodone (for sale)141,375,000
Oxymorphone (for conversion)29,000,000
Oxymorphone (for sale)7,750,000
Pentobarbital35,000,000
Phenazocine6
Phencyclidine38
Phenmetrazine3
Phenylacetone9,375,000
Racemethorphan5
Racemorphan3
Remifentanil4,200
Secobarbital215,003
Sufentanil6,255
Tapentadol12,500,000
Thebaine125,000,000
Start Printed Page 55646
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

Aggregate production quotas for all other schedule I and II controlled substances included in 21 CFR 1308.11 and 1308.12 remain at zero.

Start Signature

Dated: September 10, 2015.

Chuck Rosenberg,

Acting Administrator.

End Signature End Supplemental Information

[FR Doc. 2015-23199 Filed 9-15-15; 8:45 am]

BILLING CODE 4410-09-P