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

RESOURCES > Federal Register Notices > Quotas - 2017 > 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 2018

Quotas - 2017

[Federal Register Volume 82, Number 215 (Wednesday, November 8, 2017)]
[Notices]
[Pages 51873-51877]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-24306]


DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-471F]

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 2018

AGENCY: Drug Enforcement Administration, Department of Justice.

ACTION: Final order.


SUMMARY: This final order establishes the initial 2018 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.

APPLICABLE DATE: Applicable November 8, 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 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 2018 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 2018 to provide for the estimated medical, scientific, research, 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 August 7, 2017, 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 2018" was published in the Federal Register. 82 FR 36830. This notice proposed the 2018 aggregate production quotas for each basic class of controlled substance listed in schedules I and II and the 2018 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 September 6, 2017.

Comments Received

Within the public comment period, the DEA received seventeen comments from three DEA-registered manufacturers regarding sixteen different schedule I and II controlled substances and one comment from a DEA-registered manufacturer regarding the proposed assessment of annual needs for the list I chemical phenylpropanolamine (for conversion). Commenters stated the proposed aggregate production quotas for 4-anilino-n-phenethyl-4-piperadine (ANPP), amphetamine (for conversion), codeine (for sale), diphenoxylate, fentanyl, gamma hydroxybutyric acid, hydrocodone (for sale), lisdexamfetamine, methadone, methadone-intermediate, methylphenidate, morphine (for conversion), morphine (for sale), oxycodone (for sale), oxymorphone (for sale), sufentanil, as well as the proposed assessment of annual needs for phenylpropanolamine (for conversion), were insufficient to provide for the estimated medical, scientific, research, and industrial needs of the United States, export requirements, and the establishment and maintenance of reserve stocks. These comments were considered in setting the final 2018 Aggregate Production Quotas as discussed below.

In addition to these seventeen comments, the DEA received one comment from a DEA-registered manufacturer seeking clarification on whether DEA considers manufacturing at outsourcing facilities when determining the Aggregate Production Quotas. The DEA notes that it is the responsibility of all DEA-registered dosage form manufacturers to submit quota applications by April 1, in order for their individual business practices to be considered when the DEA proposes the Aggregate Production Quota for the following year. 21 CFR 1303.12(b). These quota applications and comments with discrete data regarding the quantities of the basic classes of schedule I or II controlled substances received during the comment period for the proposed Aggregate Production Quotas are taken into consideration before establishing the values presented in this Final Order. This DEA-registered manufacturer provided no quantitative data supporting the position that the proposed quota for 2018 will adversely impact outsourcing facilities for DEA to consider. The DEA also received one hundred five comments that expressed concern that DEA's proposed reduction of opioids by twenty percent would adversely impact the availability of pain relieving prescription drugs for people with chronic pain. These comments were general in nature, and raised issues of specific medical illnesses and medical treatment, and therefore are outside of the scope of this Final Order for 2018. As a result, these one hundred and six comments did not provide new discrete data for consideration, and do not impact the original analysis involved in establishing the 2018 aggregate production quotas.

Determination of 2018 Aggregate Production Quotas and Assessment of Annual Needs

In determining the 2018 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 2017 manufacturing quotas, current 2017 sales and inventories, anticipated 2018 export requirements, industrial use, additional applications for 2018 quotas, as well as information on research and product development requirements. Based on all of the above, the Administrator is adjusting the 2018 aggregate production quotas for 2-(4-bromo-2,5-dimethoxyphenyl)-n-(2-methoxybenzyl) ethanamine, 3,4,5-trimethoxy amphetamine, 4-bromo-2,5-dimethoxy-amphetamine, acryl fentanyl, alfentanil, amobarbital, methylphenidate, and nabilone, are warranted. Adjustment to the proposed assessment of annual needs for

[[Page 51874]]

pseudoephedrine (for sale) was also determined to be warranted. This final order reflects those adjustments.

Regarding 4-anilino-n-phenethyl-4-piperadine (ANPP), amphetamine (for conversion), codeine (for sale), diphenoxylate, fentanyl, gamma hydroxybutyric acid, hydrocodone (for sale), lisdexamfetamine, methadone, methadone-intermediate, morphine (for conversion), morphine (for sale), oxycodone (for sale), oxymorphone (for sale), sufentanil, and phenylpropanolamine (for conversion), the DEA has determined the proposed aggregate production quotas and assessment of annual needs are sufficient to provide for the 2018 estimated medical, scientific, research, industrial needs of the United States, export requirements, and the establishment and maintenance of reserve stocks. This final order establishes these aggregate production quotas and assessment of annual needs 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 2018 aggregate production quotas for the following schedule I and II controlled substances and the 2018 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 2018
Established
Quotas
(g)
Temporarily Scheduled Substances
Acryl fentanyl 25
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) 30
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 30
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) 30
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
ADB-FUBINACA (N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-(4-fluorobenzyl)-1H-indazole-3-carboxamide) 30
Acetyl Fentanyl 100
Acetyl-alpha-methylfentanyl 30
Acetyldihydrocodeine 30
Acetylmethadol 2
Acryl Fentanyl 25
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 192
Desomorphine 25
Diethyltryptamine 25
Difenoxin 8,225
Dihydromorphine 1,000,160
Dimethyltryptamine 35
Dipipanone 5
Etorphine 30
Fenethylline 30
Furanyl fentanyl 30
gamma-Hydroxybutyric acid 37,130,000
Heroin 45
Hydromorphinol 40
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 443,680
Mecloqualone 30
Mescaline 25
Methaqualone 60
Methcathinone 25
Methyldesorphine 5
Methyldihydromorphine 2
Morphine methylbromide 5
Morphine methylsulfonate 5
Morphine-N-oxide 150
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 384,460
Thiofentanyl 25
THJ-2201 ( [1-(5-fluoropentyl)-1H-indazol-3-yl](naphthalen-1-yl)methanone) 30
Tilidine 25
Trimeperidine 2
UR-144 (1-pentyl-1H-indol-3-yl)(2,2,3,3-tetramethylcyclopropyl)methanone 25
U-47700 30
Schedule II
1-Phenylcyclohexylamine 4
1-Piperidinocyclohexanecarbonitrile 4
4-Anilino-N-phenethyl-4-piperidine (ANPP) 1,342,320
Alfentanil 6,200
Alphaprodine 2
Amobarbital 20,100
Amphetamine (for conversion) 11,280,000
Amphetamine (for sale) 39,856,000
Carfentanil 20
Cocaine 92,120
Codeine (for conversion) 15,040,000
Codeine (for sale) 40,015,800
Dextropropoxyphene 35
Dihydrocodeine 264,140
Dihydroetorphine 2
Diphenoxylate (for conversion) 14,100
Diphenoxylate (for sale) 770,800
Ecgonine 88,134
Ethylmorphine 30
Etorphine hydrochloride 32
Fentanyl 1,342,320
Glutethimide 2
Hydrocodone (for conversion) 114,680
Hydrocodone (for sale) 50,348,280
Hydromorphone 4,547,720
Isomethadone 30
Levo-alphacetylmethadol (LAAM) 5
Levomethorphan 30
Levorphanol 12,126
Lisdexamfetamine 17,869,000
Meperidine 2,717,540
Meperidine Intermediate-A 5
Meperidine Intermediate-B 30
Meperidine Intermediate-C 5
Metazocine 15
Methadone (for sale) 22,278,000
Methadone Intermediate 24,064,000
Methamphetamine 1,446,754
[846,000 grams of levo-desoxyephedrine for use in a non-controlled, non-prescription product; 564,000 grams for methamphetamine mostly for conversion to a schedule III product; and 36,754 grams for methamphetamine (for sale)]
Methylphenidate 64,600,000
Morphine (for conversion) 4,089,000
Morphine (for sale) 33,958,440
Nabilone 31,000
Noroxymorphone (for conversion) 14,044,540
Noroxymorphone (for sale) 376,000
Opium (powder) 84,600
Opium (tincture) 564,000
Oripavine 24,534,000
Oxycodone (for conversion) 2,453,400
Oxycodone (for sale) 95,692,000
Oxymorphone (for conversion) 20,962,000
Oxymorphone (for sale) 3,395,280
Pentobarbital 25,850,000
Phenazocine 5
Phencyclidine 35
Phenmetrazine 25
Phenylacetone 40
Racemethorphan 5
Racemorphan 5
Remifentanil 2,820
Secobarbital 161,682
Sufentanil 1,880
Tapentadol 18,388,280
Thebaine 94,000,000
List I Chemicals
Ephedrine (for conversion) 47,000
Ephedrine (for sale) 4,136,000
Phenylpropanolamine (for conversion) 14,100,000
Phenylpropanolamine (for sale) 7,990,000
Pseudoephedrine (for conversion) 40
Pseudoephedrine (for sale) 180,000,000

[[Page 51877]]

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 2018 aggregate production quotas and assessment of annual needs as needed.

Dated: November 1, 2017.

Robert W. Patterson,
Acting Administrator.

[FR Doc. 2017-24306 Filed 11-7-17; 8:45 am]

BILLING CODE 4410-09-P

 

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