Diversion Control Division, US Department of Justice, Drug Enforcement Administration

RESOURCES > Federal Register Notices > Quotas - 2015 > 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

Quotas - 2015

[Federal Register Volume 80, Number 179 (Wednesday, September 16, 2015)]
[Notices]
[Pages 55642-55646]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-23199]


DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-418F]

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

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.

FOR FURTHER INFORMATION CONTACT: John R. Scherbenske, Office of Diversion Control, Drug Enforcement Administration, 8701 Morrissette Drive, Springfield, Virginia 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. 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

[[Page 55643]]

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 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 Class

Final 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)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–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-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-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-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–T–4) 30
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) 25
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) 25
4-Methoxyamphetamine 100
4-Methyl-2,5-dimethoxyamphetamine (DOM) 25
4-Methylaminorex 25
4-Methyl-N-ethylcathinone (4–MEC) 25
4-Methyl-N-methylcathinone (mephedrone) 45
4-Methyl-a-pyrrolidinopropiophenone (4-MePPP) 25
5-(1,1-Dimethylheptyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-phenol 68
5-(1,1-Dimethyloctyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-phenol (cannabicyclohexanol or CP–47,497 C8-homolog) 53
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 (α-PBP) 25
alpha-Pyrrolidinopentiophenone (α-PVP) 25
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 25
Diethyltryptamine 25
Difenoxin 11,000
Dihydromorphine 3,990,000
Dimethyltryptamine 35
Dipipanone 5
Fenethylline 5
gamma-Hydroxybutyric acid 70,250,000
Heroin 50
Hydromorphinol 2
Hydroxypethidine 2
Ibogaine 5
Lysergic acid diethylamide (LSD) 35
Marihuana 658,000
Mescaline 25
Methaqualone 10
Methcathinone 25
Methyldesorphine 5
Methyldihydromorphine 2
Morphine methylbromide 5
Morphine methylsulfonate 5
Morphine-N-oxide 350
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-Dimethylamphetamine 25
Naphthylpyrovalerone (naphyrone) 25
N-Benzylpiperazine 25
N-Ethyl-1-phenylcyclohexylamine 5
N-Ethylamphetamine 24
N-Hydroxy-3,4-methylenedioxyamphetamine 24
Noracymethadol 2
Norlevorphanol 52
Normethadone 2
Normorphine 40
Para-fluorofentanyl 5
Parahexyl 5
Phenomorphan 2
Pholcodine 5
Psilocybin 30
Psilocyn 30
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
Tetrahydrocannabinols 511,250
Thiofentanyl 2
Tilidine 25
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) 63,900,000
Dextropropoxyphene 45
Dihydrocodeine 226,375
Dihydroetorphine 3
Diphenoxylate (for conversion) 75,000
Diphenoxylate (for sale) 1,337,500
Ecgonine 174,375
Ethylmorphine 5
Etorphine hydrochloride 3
Fentanyl 2,300,000
Glutethimide 3
Hydrocodone (for conversion) 137,500
Hydrocodone (for sale) 99,625,000
Hydromorphone 7,000,000
Isomethadone 5
Levo-alphacetylmethadol (LAAM) 4
Levomethorphan 30
Levorphanol 7,125
Lisdexamfetamine 29,750,000
Meperidine 6,250,000
Meperidine Intermediate-A 6
Meperidine Intermediate-B 32
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 96,750,000
Morphine (for conversion) 91,250,000
Morphine (for sale) 62,500,000
Nabilone 18,750
Noroxymorphone (for conversion) 17,500,000
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) 141,375,000
Oxymorphone (for conversion) 29,000,000
Oxymorphone (for sale) 7,750,000
Pentobarbital 35,000,000
Phenazocine 6
Phencyclidine 38
Phenmetrazine 3
Phenylacetone 9,375,000
Racemethorphan 5
Racemorphan 3
Remifentanil 4,200
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

[[Page 55646]]

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: September 10, 2015.

Chuck Rosenberg,
Acting Administrator.

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

BILLING CODE 4410-09-P

 

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