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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 2017

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Information about this document as published in the Federal Register.

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Start Preamble

AGENCY:

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

ACTION:

Final order.

SUMMARY:

This final order establishes the final adjusted 2017 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 applicable November 3, 2017.

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) 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 Drug Enforcement Administration (DEA) pursuant to 28 CFR 0.100.

Background

The DEA published the 2017 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 5, 2016. 81 FR 69079. This notice stated that the Start Printed Page 51294Administrator would adjust, as needed, the established aggregate production quotas in 2017 in accordance with 21 CFR 1303.13 and 21 CFR 1315.13. The 2017 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 August 4, 2017, (82 FR 36449) 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 September 5, 2017.

Comments Received

Three DEA-registered entities submitted timely comments regarding a total of eleven schedule I and II controlled substances. Comments received proposed that the aggregate production quotas for amphetamine (for conversion), dihydrocodeine, diphenoxylate (for sale), heroin, levorphanol, lisdexamfetmine, methadone intermediate, noroxymorphone (for conversion), oripavine, oxycodone (for sale), and oxymorphone (for conversion) 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 43 comments from non-DEA registered entities in response to the DEA's August 4, 2017, press release for the proposed 2018 aggregate production quotas. The majority of these commenters expressed concerns about the 20 percent decrease to the production quotas of controlled substances. The DEA also received two comments from non-DEA registered entities suggesting that the rescheduling of marihuana would drastically reduce opioid use, misuse, and addiction. These 45 comments addressed issues that were outside the scope of this final order, and therefore are not relevant to the analysis involved in finalizing the 2017 aggregate production quotas.

The DEA received no comments from DEA-registered or non-DEA registered entities for previously established values of the 2017 assessment of annual needs for ephedrine, pseudoephedrine, and phenylpropanolamine.

Analysis for Final Adjusted 2017 Aggregate Production Quotas and Assessment of Annual Needs

In determining the final adjusted 2017 aggregate production quotas and assessment of annual needs, the DEA has taken into consideration the above comments that are specifically relevant to this Final Order for calendar year 2017 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 2016 year-end inventories, initial 2017 manufacturing and import quotas, 2017 export requirements, actual and projected 2017 sales, research and product development requirements, and additional applications received. Based on all of the above, the Administrator is adjusting the 2017 aggregate production quotas and assessment of annual needs for 4-Anilino-N-Phenethyl-4-Piperidine (ANPP), dihydrocodeine, ephedrine (for sale), fentanyl, hydrocodone (for sale), meperidine, methadone intermediate, morphine (for sale), opium (tincture), Oripavine, oxycodone (for sale), Oxymorphone (for conversion), Oxymorphone (for sale), phenylpropanolamine (for conversion), phenylpropanolamine (for sale), pseudoephedrine (for sale), tapentadol, and thiafentanil. This final order reflects those adjustments.

Regarding diphenoxylate (for sale), heroin, levorphanol, and noroxymorphone (for conversion) the Administrator hereby determines that the proposed adjusted 2017 aggregate production quotas and assessment of annual needs for these substances and list I chemicals as published on August 4, 2017, (82 FR 36449) are sufficient to meet the current 2017 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.

Pursuant to the above, the Administrator hereby finalizes 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 classFinal revised 2017 quotas (g)
Schedule I
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-Benzylpiperazine25
1-Methyl-4-phenyl-4-propionoxypiperidine2
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)30
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
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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-Methylfentanyl30
3-Methylthiofentanyl30
4-Bromo-2,5-dimethoxyamphetamine (DOB)25
4-Bromo-2,5-dimethoxyphenethylamine (2-CB)25
4-Fluoroisobutyryl fentanyl30
4-FMC; Flephedrone25
4-MEC; 4-Methyl-N-ethylcathinone25
4-Methoxyamphetamine150
4-Methyl-2,5-dimethoxyamphetamine (DOM)25
4-Methylaminorex25
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
5F-ADB; 5F-MDMB-PINACA (methyl 2-(1-(5-fluoropentyl)-1H-indazole-3-carboxamido)-3,3-dimethylbutanoate)30
5F-AMB (methyl 2-(1-(5-fluoropentyl)-1 H-indazole-3-carboxamido)-3-methylbutanoate)30
5F-APINACA; 5F-AKB48 (N-(adamantan-1-yl)-1-(5-fluoropentyl)-1 H-indazole-3-carboxamide)30
5-Fluoro-PB-22; 5F-PB-2220
5-Fluoro-UR144, XLR11 ([1-(5-fluoro-pentyl)-1 H indol-3-yl](2,2,3,3-tetramethylcyclopropyl)methanone25
5-Methoxy-3,4-methylenedioxyamphetamine25
5-Methoxy-N,N-diisopropyltryptamine25
5-Methoxy-N,N-dimethyltryptamine25
AB-CHMINACA30
AB-FUBINACA50
AB-PINACA30
Acetyl Fentanyl100
Acetyl-alpha-methylfentanyl30
Acetyldihydrocodeine30
Acetylmethadol2
ADB-FUBINACA (N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-(4-fluorobenzyl)-1 H-indazole-3-carboxamide)30
ADB-PINACA (N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-pentyl-1 H-indazole-3-carboxamide)50
AH-792130
Allylprodine2
Alphacetylmethadol2
alpha- Ethyltryptamine25
Alphameprodine2
Alphamethadol2
alpha-Methylfentanyl30
alpha-Methylthiofentanyl30
alpha-Methyltryptamine (AMT)25
alpha-Pyrrolidinobutiophenone (α-PBP)25
alpha-Pyrrolidinopentiophenone (α-PVP)25
Aminorex25
APINCA, AKB48 (N-(1-adamantyl)-1-pentyl-1 H-indazole-3-carboxamide)25
Benzylmorphine30
Betacetylmethadol2
beta-Hydroxy-3-methylfentanyl30
beta-Hydroxyfentanyl30
beta-Hydroxythiofentanyl30
Betameprodine2
Betamethadol4
Betaprodine2
Bufotenine3
Butylone25
Butyryl Fentanyl30
Cathinone24
Codeine Methylbromide30
Codeine-N-oxide330
Desomorphine25
Diethyltryptamine25
Difenoxin8,750
Dihydromorphine1,566,000
Dimethyltryptamine35
Dipipanone5
Etorphine30
Fenethylline30
Furanyl Fentanyl30
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gamma-Hydroxybutyric acid56,200,000
Heroin45
Hydromorphinol2
Hydroxypethidine2
Ibogaine30
JWH-018 and AM678 (1-Pentyl-3-(1-naphthoyl)indole)35
JWH-019 (1-Hexyl-3-(1-naphthoyl)indole)45
JWH-073 (1-Butyl-3-(1-naphthoyl)indole)45
JWH-081 (1-Pentyl-3-[1-(4-methoxynaphthoyl)]indole)30
JWH-122 (1-Pentyl-3-(4-methyl-1-naphthoyl)indole)30
JWH-200 (1-[2-(4-Morpholinyl)ethyl]-3-(1-naphthoyl)indole)35
JWH-203 (1-Pentyl-3-(2-chlorophenylacetyl)indole)30
JWH-250 (1-Pentyl-3-(2-methoxyphenylacetyl)indole)30
JWH-398 (1-Pentyl-3-(4-chloro-1-naphthoyl)indole)30
Lysergic acid diethylamide (LSD)40
MAB-CHMINACA; ADB-CHMINACA (N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-(cyclohexylmethyl)-1 H-indazole-3-carboxamide)30
MDMB-CHMICA; MMB-CHMINACA(methyl 2-(1-(cyclohexylmethyl)-1 H-indole-3-carboxamido)-3,3-dimethylbutanoate)30
MDMB-FUBINACA (methyl 2-(1-(4-fluorobenzyl)-1 H-indazole-3-carboxamido)-3,3-dimethylbutanoate)30
Marihuana472,000
Mecloqualone30
Mescaline25
Methaqualone60
Methcathinone25
Methyldesorphine5
Methyldihydromorphine2
Morphine methylbromide5
Morphine methylsulfonate5
Morphine-N-oxide350
N,N-Dimethylamphetamine25
Naphyrone25
N-Ethyl-1-phenylcyclohexylamine5
N-Ethylamphetamine24
N-Hydroxy-3,4-methylenedioxyamphetamine24
Noracymethadol2
Norlevorphanol55
Normethadone2
Normorphine40
para-Fluorofentanyl25
Parahexyl5
PB-22; QUPIC20
Pentedrone25
Pentylone25
Phenomorphan2
Pholcodine5
Psilocybin30
Psilocyn50
SR-18 and RCS-8 (1-Cyclohexylethyl-3-(2-methoxyphenylacetyl)indole)45
SR-19 and RCS-4 (1-Pentyl-3-[(4-methoxy)-benzoyl]indole)30
Tetrahydrocannabinols409,000
Thiofentanil25
THJ-2201 ( [1-(5-fluoropentyl)-1H-indazol-3-yl](naphthalen-1-yl)methanone)30
Tilidine25
Trimeperidine2
U-4770030
UR-144 (1-pentyl-1H-indol-3-yl)(2,2,3,3-tetramethylcyclopropyl)methanone25
Schedule II
1-Phenylcyclohexylamine4
1-Piperidinocyclohexanecarbonitrile4
4-Anilino-N-phenethyl-4-piperidine (ANPP)1,050,000
Alfentanil4,200
Alphaprodine2
Amobarbital20,100
Amphetamine (for conversion)12,000,000
Amphetamine (for sale)42,400,000
Carfentanil20
Cocaine103,400
Codeine (for conversion)40,000,000
Codeine (for sale)45,000,000
Dextropropoxyphene35
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Dihydrocodeine360,000
Dihydroetorphine2
Diphenoxylate (for conversion)15,000
Diphenoxylate (for sale)1,110,000
Ecgonine99,000
Ethylmorphine30
Etorphine Hydrochloride32
Fentanyl1,350,000
Glutethimide2
Hydrocodone (for conversion)122,000
Hydrocodone (for sale)51,900,000
Hydromorphone5,140,800
Isomethadone30
Levo-alphacetylmethadol (LAAM)5
Levomethorphan30
Levorphanol12,900
Lisdexamfetamine19,000,000
Meperidine2,904,000
Meperidine Intermediate-A5
Meperidine Intermediate-B30
Meperidine Intermediate-C5
Metazocine15
Methadone (for sale)23,700,000
Methadone Intermediate28,700,000
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)35,000,000
Nabilone19,000
Noroxymorphone (for conversion)17,700,000
Noroxymorphone (for sale)400,000
Opium (powder)90,000
Opium (tincture)500,000
Oripavine28,900,000
Oxycodone (for conversion)2,610,000
Oxycodone (for sale)101,500,000
Oxymorphone (for conversion)23,000,000
Oxymorphone (for sale)3,600,000
Pentobarbital27,500,000
Phenazocine5
Phencyclidine35
Phenmetrazine25
Phenylacetone40
Racemethorphan5
Racemorphan5
Remifentanil3,000
Secobarbital172,002
Sufentanil4,000
Tapentadol18,600,000
Thiafentanil30
Thebaine100,000,000
List I Chemicals
Ephedrine (for conversion)50,000
Ephedrine (for sale)4,810,000
Phenylpropanolamine (for conversion)13,600,000
Phenylpropanolamine (for sale)7,000,000
Pseudoephedrine (for conversion)40
Pseudoephedrine (for sale)186,000,000
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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 27, 2017.

Robert W. Patterson,

Acting Administrator.

End Signature End Supplemental Information

[FR Doc. 2017-24009 Filed 11-2-17; 8:45 am]

BILLING CODE 4410-09-P