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Notice

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 2017

Document Details

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 initial 2017 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 October 5, 2016.

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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) requires the Attorney General to establish aggregate production quotas for each basic class of controlled substance 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 2017 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 that may be manufactured in the United States in 2017 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 22, 2016, a notice titled “Proposed 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 2017” was published in the Federal Register. 81 FR 47821. This notice proposed the 2017 aggregate production quotas for each basic class of controlled substance listed in schedules I and II and the 2017 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 22, 2016.

Comments Received

Thirteen comments were received from five DEA-registered manufacturers and four non-DEA registered entities within the published comment period regarding 22 different schedule I and II controlled substances. The DEA received two comments from two non-DEA registered entities within the published comment period regarding the proposed assessment of annual needs for the list I chemical ephedrine (for sale). Commenters stated that the proposed aggregate production quotas for acetyl fentanyl, AH-7921, amphetamine (for conversion), amphetamine (for sale), beta-hydroxythiofentanyl, butyryl fentanyl, cocaine, codeine (for conversion), codeine (for sale), dihydrocodeine, ecgonine, hydrocodone (for sale), hydromorphone, levorphanol, lisdexamfetamine, marihuana, meperidine, methylphenidate, nabilone, opium tincture, oxycodone (for sale), and sufentanil, as well as, the proposed assessment of annual needs for ephedrine (for sale) were insufficient to provide for the estimated medical, scientific, research, and industrial needs Start Printed Page 69080of the United States, export requirements, and the establishment and maintenance of reserve stocks.

The DEA received one comment from a DEA-registrant and three comments by non-DEA registered entities regarding the proposed removal of the additional 25% of the estimated medical, scientific, and research needs for the United States. Two of the commenters requested that the DEA continue to include the additional 25%, one commenter requested transparency in the process of setting aggregate production quotas, and the last commenter agreed with the DEA that the additional 25% should not be included in aggregate production quotas values. The DEA has considered these comments, as well as the ones for specific controlled substances and ephedrine (for sale), in establishing the 2017 aggregate production quotas and assessment of annual needs.

Determination of 2017 Aggregate Production Quotas and Assessment of Annual Needs

In determining the 2017 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 1303.11 and 21 CFR 1315.11, in accordance with 21 U.S.C. 826(a), and other relevant factors, including the 2016 manufacturing quotas, current 2016 sales and inventories, anticipated 2017 export requirements, industrial use, and additional applications for 2017 quotas, as well as information on research and product development requirements. Based on this information, the DEA has removed the additional 25% from the aggregate production quotas before determining that adjustments to the proposed aggregate production quotas for 4-anilino-n-phenethyl-piperidine, amphetamine (for conversion), amphetamine (for sale), cocaine, dihydrocodeine, ecgonine, etorphine hydrochloride, hydromorphone, levorphanol, lysergic acid dimethylamide, nabilone, opium tincture, and oripavine are warranted. Adjustment to the proposed annual assessment of needs for ephedrine (for sale) was also determined to be warranted. This final order reflects those adjustments.

Regarding acetyl fentanyl, AH-7921, beta-hydroxythiofentanyl, butyryl fentanyl, codeine (for conversion), codeine (for sale), hydrocodone (for sale), lisdexamfetamine, marihuana, meperidine, methylphenidate, oxycodone (for sale), and sufentanil, the DEA has determined that the proposed aggregate production quotas are sufficient to provide for the 2017 estimated medical, scientific, research, and industrial needs of the United States, export requirements, and the establishment and maintenance of reserve stocks. This final order establishes these aggregate production quotas at the same amounts as proposed.

In accordance with 21 U.S.C. 826, 21 CFR 1303.11, and 21 CFR 1315.11, the Administrator hereby establishes the 2017 aggregate production quotas for the following schedule I and II controlled substances and the 2017 assessment of annual needs for the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine, expressed in grams of anhydrous acid or base, as follows:

Basic class2017 Established quotas (g)
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)30
1-(5-Fluoropentyl)-3-(2-iodobenzoyl)indole (AM694)30
1-[1-(2-Thienyl)cyclohexyl]piperidine15
1-[2-(4-Morpholinyl)ethyl]-3-(1-naphthoyl)indole (JWH-200)35
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)35
1-Pentyl-3-(2-chlorophenylacetyl)indole (JWH-203)30
1-Pentyl-3-(2-methoxyphenylacetyl)indole (JWH-250)30
1-Pentyl-3-(4-chloro-1-naphthoyl)indole (JWH-398)30
1-Pentyl-3-(4-methyl-1-naphthoyl)indole (JWH-122)30
1-Pentyl-3-[(4-methoxy)-benzoyl]indole (SR-19, RCS-4)30
1-Pentyl-3-[1-(4-methoxynaphthoyl)]indole (JWH-081)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-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)5
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
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3,4-Methylenedioxyamphetamine (MDA)55
3,4-Methylenedioxymethamphetamine (MDMA)50
3,4-Methylenedioxy-N-ethylamphetamine (MDEA)40
3,4-Methylenedioxy-N-methylcathinone (methylone)40
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]-phenol50
5-(1,1-Dimethyloctyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-phenol (cannabicyclohexanol or CP-47,497 C8-homolog)40
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
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
beta-Hydroxythiofentanyl30
Betacetylmethadol2
Betameprodine2
Betamethadol4
Betaprodine2
Bufotenine3
Butylone25
Butyryl fentanyl30
Cathinone24
Codeine methylbromide5
Codeine-N-oxide305
Desomorphine25
Diethyltryptamine25
Difenoxin8,750
Dihydromorphine1,566,000
Dimethyltryptamine35
Dipipanone5
Fenethylline5
gamma-Hydroxybutyric acid56,200,000
Heroin25
Hydromorphinol2
Hydroxypethidine2
Ibogaine5
Lysergic acid diethylamide (LSD)15
Marihuana472,000
Mescaline25
Methaqualone10
Methcathinone25
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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)20
Quinolin-8-yl 1-pentyl-1H-indole-3-carboxylate (PB-22; QUPIC)20
Tetrahydrocannabinols409,000
Thiofentanyl2
Tilidine25
Trimeperidine2
UR-14425
Schedule II
1-Phenylcyclohexylamine4
1-Piperidinocyclohexanecarbonitrile4
4-Anilino-N-phenethyl-4-piperidine (ANPP)1,750,000
Alfentanil4,200
Alphaprodine2
Amobarbital20,100
Amphetamine (for conversion)12,000,000
Amphetamine (for sale)42,400,000
Carfentanil10
Cocaine103,400
Codeine (for conversion)40,000,000
Codeine (for sale)45,000,000
Dextropropoxyphene15
Dihydrocodeine281,100
Dihydroetorphine2
Diphenoxylate (for conversion)15,000
Diphenoxylate (for sale)820,000
Ecgonine99,000
Ethylmorphine2
Etorphine hydrochloride32
Fentanyl1,750,000
Glutethimide2
Hydrocodone (for conversion)122,000
Hydrocodone (for sale)58,410,000
Hydromorphone5,140,800
Isomethadone4
Levo-alphacetylmethadol (LAAM)3
Levomethorphan10
Levorphanol8,300
Lisdexamfetamine19,000,000
Meperidine3,706,000
Meperidine Intermediate-A5
Meperidine Intermediate-B9
Meperidine Intermediate-C5
Metazocine15
Start Printed Page 69083
Methadone (for sale)23,700,000
Methadone Intermediate25,600,000
Methamphetamine1,539,100
[900,000 grams of levo-desoxyephedrine for use in a non-controlled, non-prescription product; 600,000 grams for methamphetamine mostly for conversion to a schedule III product; and 39,100 grams for methamphetamine (for sale)]
Methylphenidate73,000,000
Morphine (for conversion)27,300,000
Morphine (for sale)41,000,000
Nabilone19,000
Noroxymorphone (for conversion)17,700,000
Noroxymorphone (for sale)400,000
Opium (powder)90,000
Opium (tincture)907,200
Oripavine22,000,000
Oxycodone (for conversion)2,610,000
Oxycodone (for sale)108,510,000
Oxymorphone (for conversion)22,300,000
Oxymorphone (for sale)4,200,000
Pentobarbital27,500,000
Phenazocine5
Phencyclidine20
Phenmetrazine2
Phenylacetone20
Racemethorphan2
Racemorphan2
Remifentanil3,000
Secobarbital172,002
Sufentanil4,000
Tapentadol21,000,000
Thebaine100,000,000
List I Chemicals
Ephedrine (for conversion)50,000
Ephedrine (for sale)5,360,000
Phenylpropanolamine (for conversion)15,000,000
Phenylpropanolamine (for sale)8,500,000
Pseudoephedrine (for conversion)40
Pseudoephedrine (for sale)200,000,000

The 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 Administrator may adjust the 2017 aggregate production quotas and assessment of annual needs as needed.

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Dated: September 26, 2016.

Chuck Rosenberg,

Acting Administrator.

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[FR Doc. 2016-23988 Filed 10-4-16; 8:45 am]

BILLING CODE 4410-09-P