Skip to Content

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 2016

Document Details

Information about this document as published in the Federal Register.

Published Document

This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

Start Preamble

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.

Start Further Info

FOR FURTHER INFORMATION CONTACT:

Michael J. Lewis, Diversion Control Division, Drug Enforcement Administration, 8701 Morrissette Drive, Springfield, VA 22152, Telephone: (202) 598-6812.

End Further Info End Preamble Start Supplemental Information

SUPPLEMENTARY INFORMATION:

Legal Authority

Section 306 of the Controlled Substances Act (CSA) (21 U.S.C. 826), Start Printed Page 73422requires 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:Start Printed Page 73423

Basic classRevised 2016 quotas
(g)
Temporarily Scheduled Substances
beta-Hydroxythiofentanyl30
Butyryl fentanyl30
Schedule I
[1-(5-fluoropentyl)-1H-indazol-3-yl](naphthalen-1-yl)methanone (THJ-2201)15
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-Benzylpiperazine25
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-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-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-FMC; 3-Fluoro-N-methylcathinone25
3-Methylfentanyl2
3-Methylthiofentanyl2
4-Bromo-2,5-dimethoxyamphetamine (DOB)25
4-Bromo-2,5-dimethoxyphenethylamine (2-CB)25
4-FMC; Flephedrone25
4-Methoxyamphetamine150
4-Methyl-2,5-dimethoxyamphetamine (DOM)25
4-Methylaminorex25
4-MEC; 4-Methyl-N-ethylcathinone25
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-Fluoro-UR144, XLR1125
5-Methoxy-3,4-methylenedioxyamphetamine25
5-Methoxy-N,N-diisopropyltryptamine25
5-Methoxy-N,N-dimethyltryptamine25
AB-PINACA15
Acetyl-alpha-methylfentanyl2
Acetyldihydrocodeine2
Acetylmethadol2
AH-792130
Start Printed Page 73424
Allylprodine2
alpha-Ethyltryptamine25
alpha-Methylfentanyl2
alpha-Methylthiofentanyl2
alpha-Methyltryptamine (AMT)25
alpha-Pyrrolidinobutiophenone (α-PBP)25
alpha-Pyrrolidinopentiophenone (α-PVP)25
Alphacetylmethadol2
Alphameprodine2
Alphamethadol2
Aminorex25
APINCA, AKB4825
Benzylmorphine2
beta-Hydroxy-3-methylfentanyl2
beta-Hydroxyfentanyl2
Betacetylmethadol2
Betameprodine2
Betamethadol4
Betaprodine2
Bufotenine3
Butylone25
Cathinone30
Codeine methylbromide5
Codeine-N-oxide305
Desomorphine25
Diethyltryptamine25
Difenoxin11,000
Dihydromorphine2,000,000
Dimethyltryptamine35
Dipipanone5
Fenethylline5
gamma-Hydroxybutyric acid70,250,000
Heroin50
Hydromorphinol2
Hydroxypethidine2
Ibogaine5
Lysergic acid diethylamide (LSD)40
Marihuana658,000
Mescaline25
Methaqualone10
Methcathinone25
Methyldesorphine5
Methyldihydromorphine2
Morphine methylbromide5
Morphine methylsulfonate5
Morphine-N-oxide350
N,N-Dimethylamphetamine25
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-phenylcyclohexylamine5
N-Ethylamphetamine24
N-Hydroxy-3,4-methylenedioxyamphetamine24
Naphyrone25
Noracymethadol2
Norlevorphanol52
Normethadone2
Normorphine40
Para-fluorofentanyl5
Parahexyl5
Pentedrone25
Pentylone25
Phenomorphan2
Pholcodine5
Psilocybin30
Psilocyn50
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
Start Printed Page 73425
Tetrahydrocannabinols511,250
Thiofentanyl2
Tilidine25
Trimeperidine2
UR-14425
Schedule II
1-Phenylcyclohexylamine5
1-Piperidinocyclohexanecarbonitrile5
4-Anilino-N-phenethyl-4-piperidine (ANPP)2,250,000
Alfentanil17,750
Alphaprodine3
Amobarbital25,125
Amphetamine (for conversion)15,000,000
Amphetamine (for sale)50,000,000
Carfentanil19
Cocaine200,000
Codeine (for conversion)50,000,000
Codeine (for sale)63,900,000
Dextropropoxyphene55
Dihydrocodeine226,375
Dihydroetorphine3
Diphenoxylate (for conversion)18,750
Diphenoxylate (for sale)1,337,500
Ecgonine125,000
Ethylmorphine5
Etorphine hydrochloride40
Fentanyl2,300,000
Glutethimide3
Hydrocodone (for conversion)177,500
Hydrocodone (for sale)86,000,000
Hydromorphone7,000,000
Isomethadone5
Levo-alphacetylmethadol (LAAM)4
Levomethorphan33
Levorphanol9,525
Lisdexamfetamine23,750,000
Meperidine4,632,500
Meperidine Intermediate-A6
Meperidine Intermediate-B11
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)]
Methylphenidate84,375,000
Morphine (for conversion)91,250,000
Morphine (for sale)62,500,000
Nabilone18,875
Noroxymorphone (for conversion)17,500,000
Noroxymorphone (for sale)875,000
Opium (powder)112,500
Opium (tincture)375,000
Oripavine30,000,000
Oxycodone (for conversion)5,000,000
Oxycodone (for sale)139,150,000
Oxymorphone (for conversion)25,000,000
Oxymorphone (for sale)6,250,000
Pentobarbital38,125,000
Phenazocine6
Phencyclidine60
Phenmetrazine3
Phenylacetone50
Racemethorphan5
Racemorphan3
Start Printed Page 73426
Remifentanil3,750
Secobarbital243,380
Sufentanil6,255
Tapentadol25,500,000
Thebaine125,000,000
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

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: October 19, 2016.

Chuck Rosenberg,

Acting Administrator.

End Signature End Supplemental Information

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

BILLING CODE 4410-09-P