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

RESOURCES > Federal Register Notices > Quotas - 2017 > 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

Quotas - 2017

[Federal Register Volume 82, Number 212 (Friday, November 3, 2017)]
[Notices]
[Pages 51293-51298]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-24009]


DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-470F]

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

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.

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) 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

[[Page 51294]]

Administrator 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 Class Final
Revised 2017
Quotas
(g)
Schedule I
1-(1-Phenylcyclohexyl)pyrrolidine 10
1-(5-Fluoropentyl)-3-(1-naphthoyl)indole (AM2201) 30
1-(5-Fluoropentyl)-3-(2-iodobenzoyl)indole (AM694) 30
1-[1-(2-Thienyl)cyclohexyl]piperidine 15
1-Benzylpiperazine 25
1-Methyl-4-phenyl-4-propionoxypiperidine 2
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-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) 40
3,4-Methylenedioxypyrovalerone (MDPV) 35
3-FMC; 3-Fluoro-N-methylcathinone 25
3-Methylfentanyl 30
3-Methylthiofentanyl 30
4-Bromo-2,5-dimethoxyamphetamine (DOB) 25
4-Bromo-2,5-dimethoxyphenethylamine (2-CB) 25
4-Fluoroisobutyryl fentanyl 30
4-FMC; Flephedrone 25
4-MEC; 4-Methyl-N-ethylcathinone 25
4-Methoxyamphetamine 150
4-Methyl-2,5-dimethoxyamphetamine (DOM) 25
4-Methylaminorex 25
4-Methyl-N-methylcathinone (mephedrone) 45
4-Methyl-α-pyrrolidinopropiophenone (4-MePPP) 25
5-(1,1-Dimethylheptyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-phenol 50
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)-1H-indazole-3-carboxamido)-3-methylbutanoate) 30
5F-APINACA; 5F-AKB48 (N-(adamantan-1-yl)-1-(5-fluoropentyl)-1H-indazole-3-carboxamide) 30
5-Fluoro-PB-22; 5F-PB-22 20
5-Fluoro-UR144, XLR11 ([1-(5-fluoro-pentyl)-1Hindol-3-yl](2,2,3,3-tetramethylcyclopropyl)methanone 25
5-Methoxy-3,4-methylenedioxyamphetamine 25
5-Methoxy-N,N-diisopropyltryptamine 25
5-Methoxy-N,N-dimethyltryptamine 25
AB-CHMINACA 30
AB-FUBINACA 50
AB-PINACA 30
Acetyl Fentanyl 100
Acetyl-alpha-methylfentanyl 30
Acetyldihydrocodeine 30
Acetylmethadol 2
ADB-FUBINACA (N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-(4-fluorobenzyl)-1H-indazole-3-carboxamide) 30
ADB-PINACA (N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-pentyl-1H-indazole-3-carboxamide) 50
AH-7921 30
Allylprodine 2
Alphacetylmethadol 2
alpha-Ethyltryptamine 25
Alphameprodine 2
Alphamethadol 2
alpha-Methylfentanyl 30
alpha-Methylthiofentanyl 30
alpha-Methyltryptamine (AMT) 25
alpha-Pyrrolidinobutiophenone (α-PBP) 25
alpha-Pyrrolidinopentiophenone (α-PVP) 25
Aminorex 25
APINCA, AKB48 (N-(1-adamantyl)-1-pentyl-1H-indazole-3-carboxamide) 25
Benzylmorphine 30
Betacetylmethadol 2
beta-Hydroxy-3-methylfentanyl 30
beta-Hydroxyfentanyl 30
beta-Hydroxythiofentanyl 30
Betameprodine 2
Betamethadol 4
Betaprodine 2
Bufotenine 3
Butylone 25
Butyryl Fentanyl 30
Cathinone 24
Codeine Methylbromide 30
Codeine-N-oxide 330
Desomorphine 25
Diethyltryptamine 25
Difenoxin 8,750
Dihydromorphine 1,566,000
Dimethyltryptamine 35
Dipipanone 5
Etorphine 30
Fenethylline 30
Furanyl Fentanyl 30
gamma-Hydroxybutyric acid 56,200,000
Heroin 45
Hydromorphinol 2
Hydroxypethidine 2
Ibogaine 30
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)-1H-indazole-3-carboxamide) 30
MDMB-CHMICA; MMB-CHMINACA(methyl 2-(1-(cyclohexylmethyl)-1H-indole-3-carboxamido)-3,3-dimethylbutanoate) 30
MDMB-FUBINACA (methyl 2-(1-(4-fluorobenzyl)-1H-indazole-3-carboxamido)-3,3-dimethylbutanoate) 30
Marihuana 472,000
Mecloqualone 30
Mescaline 25
Methaqualone 60
Methcathinone 25
Methyldesorphine 5
Methyldihydromorphine 2
Morphine methylbromide 5
Morphine methylsulfonate 5
Morphine-N-oxide 350
N,N-Dimethylamphetamine 25
Naphyrone 25
N-Ethyl-1-phenylcyclohexylamine 5
N-Ethylamphetamine 24
N-Hydroxy-3,4-methylenedioxyamphetamine 24
Noracymethadol 2
Norlevorphanol 55
Normethadone 2
Normorphine 40
para-Fluorofentanyl 25
Parahexyl 5
PB-22; QUPIC 20
Pentedrone 25
Pentylone 25
Phenomorphan 2
Pholcodine 5
Psilocybin 30
Psilocyn 50
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
Tetrahydrocannabinols 409,000
Thiofentanil 25
THJ-2201 ( [1-(5-fluoropentyl)-1H-indazol-3-yl](naphthalen-1-yl)methanone) 30
Tilidine 25
Trimeperidine 2
U-47700 30
UR-144 (1-pentyl-1H-indol-3-yl)(2,2,3,3-tetramethylcyclopropyl)methanone 25
Schedule II
1-Phenylcyclohexylamine 4
1-Piperidinocyclohexanecarbonitrile 4
4-Anilino-N-phenethyl-4-piperidine (ANPP) 1,050,000
Alfentanil 4,200
Alphaprodine 2
Amobarbital 20,100
Amphetamine (for conversion) 12,000,000
Amphetamine (for sale) 42,400,000
Carfentanil 20
Cocaine 103,400
Codeine (for conversion) 40,000,000
Codeine (for sale) 45,000,000
Dextropropoxyphene 35
Dihydrocodeine 360,000
Dihydroetorphine 2
Diphenoxylate (for conversion) 15,000
Diphenoxylate (for sale) 1,110,000
Ecgonine 99,000
Ethylmorphine 30
Etorphine Hydrochloride 32
Fentanyl 1,350,000
Glutethimide 2
Hydrocodone (for conversion) 122,000
Hydrocodone (for sale) 51,900,000
Hydromorphone 5,140,800
Isomethadone 30
Levo-alphacetylmethadol (LAAM) 5
Levomethorphan 30
Levorphanol 12,900
Lisdexamfetamine 19,000,000
Meperidine 2,904,000
Meperidine Intermediate-A 5
Meperidine Intermediate-B 30
Meperidine Intermediate-C 5
Metazocine 15
Methadone (for sale) 23,700,000
Methadone Intermediate 28,700,000
Methamphetamine 1,539,100
[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)]
Methylphenidate 73,000,000
Morphine (for conversion) 27,300,000
Morphine (for sale) 35,000,000
Nabilone 19,000
Noroxymorphone (for conversion) 17,700,000
Noroxymorphone (for sale) 400,000
Opium (powder) 90,000
Opium (tincture) 500,000
Oripavine 28,900,000
Oxycodone (for conversion) 2,610,000
Oxycodone (for sale) 101,500,000
Oxymorphone (for conversion) 23,000,000
Oxymorphone (for sale) 3,600,000
Pentobarbital 27,500,000
Phenazocine 5
Phencyclidine 35
Phenmetrazine 25
Phenylacetone 40
Racemethorphan 5
Racemorphan 5
Remifentanil 3,000
Secobarbital 172,002
Sufentanil 4,000
Tapentadol 18,600,000
Thiafentanil 30
Thebaine 100,000,000
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

[[Page 51298]]

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 27, 2017.

Robert W. Patterson,
Acting Administrator.

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

BILLING CODE 4410-09-P

 

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