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

RESOURCES > Federal Register Notices > Quotas - 2016 > 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 2016

Quotas - 2016

[Federal Register Volume 81, Number 206 (Tuesday, October 25, 2016)]
[Notices]
[Pages 73421-73426]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-25696]


DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-420F]

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 2016

AGENCY: Drug Enforcement Administration (DEA), Department of Justice (DOJ).

ACTION: Final order.


SUMMARY: This final order establishes the final adjusted 2016 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: This order is effective October 25, 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),

[[Page 73422]]

requires the Attorney General to establish aggregate production quotas for each basic class of controlled substances 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 DEA published the 2016 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 on October 6, 2015. 80 FR 60400. This notice stated that the Administrator would adjust, as needed, the established aggregate production quotas in 2016 in accordance with 21 CFR 1303.13 and 21 CFR 1315.13. The 2016 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 July 22, 2016, (81 FR 47829) 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 August 22, 2016.

Comments Received

Four DEA-registered entities submitted timely comments regarding a total of six schedule I and II controlled substances. Comments received proposed that the aggregate production quotas for amphetamine (for sale), etorphine hydrochloride, methadone, methadone intermediate, nabilone, and phencyclidine 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 received one comment from a non-DEA registered entity requesting the reduction of oxycodone (for sale) to pre-2013 levels. The DEA received one comment from a DEA registrant regarding the proposed removal of the additional 25% of the estimated medical, scientific, and research needs of the United States for the calendar year 2017 published in the Federal Register on July 22, 2016 (81 FR 47821).

The DEA received one comment from a DEA-registered entity and two comments from non-DEA registered entities for the proposed adjustments to the 2016 assessment of annual needs for ephedrine, pseudoephedrine, and phenylpropanolamine. Comments received proposed that the annual assessment of needs for ephedrine (for sale) and pseudoephedrine (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.

Analysis for Final Adjusted 2016 Aggregate Production Quotas and Assessment of Annual Needs

In determining the final adjusted 2016 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 1303.13 and 21 CFR 1315.13 in accordance with 21 U.S.C. 826(a), and other relevant factors including the 2015 year-end inventories, initial 2016 manufacturing and import quotas, 2016 export requirements, actual and projected 2016 sales, research and product development requirements, and additional applications received. Based on all of the above, the Administrator has determined that the proposed adjusted 2016 aggregate production quotas and assessment of annual needs for amphetamine (for sale), etorphine hydrochloride, dextropropoxyphene, levorphanol, nabilone, noroxymorphone (for sale), phencyclidine, and secobarbital required additional consideration, and hereby further adjusts the 2016 aggregate production quotas and assessment of annual needs for these substances. This final order reflects those adjustments.

Regarding ephedrine (for sale), methadone, methadone intermediate, oxycodone (for sale), and pseudoephedrine (for sale) the Administrator hereby determines that the proposed adjusted 2016 aggregate production quotas and assessment of annual needs for these substances and list I chemicals as published on July 22, 2016, (81 FR 47829) are sufficient to meet the current 2016 estimated medical, scientific, research, and industrial needs of the United States and to provide for adequate reserve stock. This final order establishes these aggregate production quotas at the same amounts as proposed.

As described in the previously published notice establishing the 2016 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. 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 final 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 final aggregate production quotas 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 Administrator hereby finalizes the 2016 aggregate production quotas for the following schedule I and II controlled substances and the 2016 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 Revised 2016
Quotas
(g)
Temporarily Scheduled Substances
beta-Hydroxythiofentanyl 30
Butyryl fentanyl 30
Schedule I
 [1-(5-fluoropentyl)-1H-indazol-3-yl](naphthalen-1-yl)methanone (THJ-2201) 15
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-Benzylpiperazine 25
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-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-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
2,5-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-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-α-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-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 (α-PBP) 25
alpha-Pyrrolidinopentiophenone (α-PVP) 25
Alphacetylmethadol  2
Alphameprodine  2
Alphamethadol  2
Aminorex 25
APINCA, AKB48 25
Benzylmorphine  2
beta-Hydroxy-3-methylfentanyl  2
beta-Hydroxyfentanyl  2
Betacetylmethadol  2
Betameprodine  2
Betamethadol  4
Betaprodine  2
Bufotenine  3
Butylone 25
Cathinone 30
Codeine methylbromide  5
Codeine-N-oxide 305
Desomorphine 25
Diethyltryptamine 25
Difenoxin 11,000
Dihydromorphine 2,000,000
Dimethyltryptamine 35
Dipipanone  5
Fenethylline  5
gamma-Hydroxybutyric acid 70,250,000
Heroin 50
Hydromorphinol  2
Hydroxypethidine  2
Ibogaine  5
Lysergic acid diethylamide (LSD) 40
Marihuana 658,000
Mescaline 25
Methaqualone 10
Methcathinone 25
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-indazole-3-carboxamide (ADB-PINACA) 50
N-(1-Amino-3-methyl-1-oxobutan-2-yl)-1-(4-fluorobenzyl)-1H-indazole-3-carboxamide (AB-FUBINACA) 50
N-(1-Amino-3-methyl-1-oxobutan-2-yl)-1-(cyclohexylmethyl)-1H-indazole-3-carboxamide (AB-CHMINACA)  15
N-(1-phenethylpiperidin-4-yl)-N-phenylacetamide (acetyl fentanyl) 100
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 (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
UR-144 25
Schedule II
1-Phenylcyclohexylamine  5
1-Piperidinocyclohexanecarbonitrile  5
4-Anilino-N-phenethyl-4-piperidine (ANPP) 2,250,000
Alfentanil 17,750
Alphaprodine  3
Amobarbital 25,125
Amphetamine (for conversion) 15,000,000
Amphetamine (for sale) 50,000,000
Carfentanil 19
Cocaine 200,000
Codeine (for conversion) 50,000,000
Codeine (for sale) 63,900,000
Dextropropoxyphene 55
Dihydrocodeine 226,375
Dihydroetorphine  3
Diphenoxylate (for conversion) 18,750
Diphenoxylate (for sale) 1,337,500
Ecgonine 125,000
Ethylmorphine  5
Etorphine hydrochloride 40
Fentanyl 2,300,000
Glutethimide  3
Hydrocodone (for conversion) 177,500
Hydrocodone (for sale) 86,000,000
Hydromorphone 7,000,000
Isomethadone  5
Levo-alphacetylmethadol (LAAM)  4
Levomethorphan 33
Levorphanol 9,525
Lisdexamfetamine 23,750,000
Meperidine 4,632,500
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 84,375,000
Morphine (for conversion) 91,250,000
Morphine (for sale) 62,500,000
Nabilone 18,875
Noroxymorphone (for conversion) 17,500,000
Noroxymorphone (for sale) 875,000
Opium (powder) 112,500
Opium (tincture) 375,000
Oripavine 30,000,000
Oxycodone (for conversion) 5,000,000
Oxycodone (for sale) 139,150,000
Oxymorphone (for conversion) 25,000,000
Oxymorphone (for sale) 6,250,000
Pentobarbital 38,125,000
Phenazocine  6
Phencyclidine 60
Phenmetrazine  3
Phenylacetone 50
Racemethorphan  5
Racemorphan  3
Remifentanil 3,750
Secobarbital 243,380
Sufentanil 6,255
Tapentadol 25,500,000
Thebaine 125,000,000
List I Chemicals
Ephedrine (for conversion) 50,000
Ephedrine (for sale) 4,000,000
Phenylpropanolamine (for conversion) 15,000,000
Phenylpropanolamine (for sale) 8,500,000
Pseudoephedrine (for conversion) 40
Pseudoephedrine (for sale) 200,000,000

[[Page 73426]]

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: October 19, 2016.

Chuck Rosenberg,
Acting Administrator.

[FR Doc. 2016-25696 Filed 10-24-16; 8:45 am]

BILLING CODE 4410-09-P

 

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