Proposed Adjustments to the 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
Federal RegisterAug 23, 2018
Ask Donna
What actually matters in this document.
Text
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-471P]
Proposed Adjustments to the 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:
Notice with request for comments.
SUMMARY:
The Drug Enforcement Administration (DEA) proposes to adjust the 2018 aggregate production quotas for several controlled substances in schedules I and II of the Controlled Substances Act and assessment of annual needs for the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine.
DATES:
Interested persons may file written comments on this notice in accordance with 21 CFR 1303.13(c) and 1315.13(d). Electronic comments must be submitted, and written comments must be postmarked, on or before September 24, 2018. Commenters should be aware that the electronic Federal Docket Management System will not accept comments after 11:59 p.m. Eastern Time on the last day of the comment period.
Based on comments received in response to this notice, the Administrator may hold a public hearing on one or more issues raised. In the event the Administrator decides in his sole discretion to hold such a hearing, the Administrator will publish a notice of any such hearing in the
Federal Register.
After consideration of any comments or objections, or after a hearing, if one is held, the Administrator will publish in the
Federal Register
a final order establishing the 2018 adjusted aggregate
production quotas for schedule I and II controlled substances, and an assessment of annual needs for the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine.
ADDRESSES:
To ensure proper handling of comments, please reference “Docket No. DEA-471P” on all correspondence, including any attachments. The Drug Enforcement Administration encourages that all comments be submitted electronically through the Federal eRulemaking Portal, which provides the ability to type short comments directly into the comment field on the web page or attach a file for lengthier comments. Please go to
http://www.regulations.gov
and follow the online instructions at that site for submitting comments. Upon completion of your submission you will receive a Comment Tracking Number for your comment. Please be aware that submitted comments are not instantaneously available for public view on
regulations.gov.
If you have received a Comment Tracking Number, your comment has been successfully submitted and there is no need to resubmit the same comment. Paper comments that duplicate electronic submissions are not necessary and are discouraged. Should you wish to mail a paper comment
in lieu
of an electronic comment, it should be sent via regular or express mail to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DRW, 8701 Morrissette Drive, Springfield, Virginia 22152.
FOR FURTHER INFORMATION CONTACT:
Thomas D. Sonnen, Diversion Control Division, Drug Enforcement Administration; Mailing Address: 8701 Morrissette Drive, Springfield, Virginia 22152, Telephone: (202) 598-6812.
SUPPLEMENTARY INFORMATION:
Posting of Public Comments
Please note that all comments received in response to this docket are considered part of the public record. They will, unless reasonable cause is given, be made available by the Drug Enforcement Administration (DEA) for public inspection online at
http://www.regulations.gov.
Such information includes personal identifying information (such as your name, address, etc.) voluntarily submitted by the commenter.
The Freedom of Information Act (FOIA) applies to all comments received. If you want to submit personal identifying information (such as your name, address, etc.) as part of your comment, but do not want it to be made publicly available, you must include the phrase “PERSONAL IDENTIFYING INFORMATION” in the first paragraph of your comment. You must also place all the personal identifying information you do not want made publicly available in the first paragraph of your comment and identify what information you want redacted.
If you want to submit confidential business information as part of your comment, but do not want it to be made publicly available, you must include the phrase “CONFIDENTIAL BUSINESS INFORMATION” in the first paragraph of your comment. You must also prominently identify confidential business information to be redacted within the comment.
Comments containing personal identifying information or confidential business information identified and located as directed above will generally be made available in redacted form. If a comment contains so much confidential business information or personal identifying information that it cannot be effectively redacted, all or part of that comment may not be made publicly available. Comments posted to
http://www.regulations.gov
may include any personal identifying information (such as name, address, and phone number) included in the text of your electronic submission that is not identified as directed above as confidential.
An electronic copy of this document is available at
http://www.regulations.gov
for easy reference.
Legal Authority and Background
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.
The DEA established the 2018 aggregate production quotas for substances in schedules I and II and the assessment of annual needs for the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine on November 8, 2017 (82 FR 51873). That notice stipulated that, in accordance with 21 CFR 1303.13 and 1315.13, all aggregate production quotas and assessments of annual need are subject to adjustment.
Analysis for Proposed Adjusted 2018 Aggregate Production Quotas and Assessment of Annual Needs
The DEA proposes to adjust the established 2018 aggregate production quotas and assessment of annual needs for certain schedule I and II controlled substances, and the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine, to be manufactured in the United States in 2018 to provide for the estimated medical, scientific, research, and industrial needs of the United States, for lawful export requirements, and for the establishment and maintenance of reserve stocks. These quotas do not include imports of controlled substances for use in industrial processes.
In determining the proposed adjustment, the Acting Administrator has taken into account the criteria in accordance with 21 CFR 1303.13 (adjustment of aggregate production quotas for controlled substances) and 21 CFR 1315.13 (adjustment of the assessment of annual needs for ephedrine, pseudoephedrine, and phenylpropanolamine). The DEA determined whether to propose an adjustment of the aggregate production quotas and assessment of annual needs for 2018 by considering: (1) Changes in the demand for that class or chemical, changes in the national rate of net disposal of the class or chemical, and changes in the rate of net disposal of the class or chemical by registrants holding individual manufacturing quotas for the class; (2) whether any increased demand for that class or chemical, the national and/or individual rates of net disposal of that class or chemical are temporary, short term, or long term; (3) whether any increased demand for that class or chemical can be met through existing inventories, increased individual manufacturing quotas, or increased importation, without increasing the aggregate production quota; (4) whether any decreased demand for that class or chemical will result in excessive inventory accumulation by all persons registered to handle that class or chemical; and (5) other factors affecting medical, scientific, research, and industrial needs in the United States and lawful export requirements, as the Acting Administrator finds relevant. These quotas do not include imports of controlled substances for use in industrial processes.
The Acting Administrator also considered updated information obtained from 2017 year-end inventories, 2017 disposition data submitted by quota applicants,
estimates of the medical needs of the United States, product development, and other information made available to the DEA after the initial aggregate production quotas and assessment of annual needs had been established. Other factors the Acting Administrator considered in calculating the aggregate production quotas, but not the assessment of annual needs, include product development requirements of both bulk and finished dosage form manufacturers, and other pertinent information. In determining the proposed adjusted 2018 assessment of annual needs, the DEA used the calculation methodology previously described in the 2010 and 2011 established assessment of annual needs (74 FR 60294, Nov. 20, 2009, and 75 FR 79407, Dec. 20, 2010, respectively).
The Acting Administrator, therefore, proposes to adjust the 2018 aggregate production quotas for certain schedule I and II controlled substances and the 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
Established 2018 quotas (g)
Proposed
revised 2018 quotas
(g)
Temporarily Scheduled Substances
1-(4-Cyanobutyl)-N-(2-phenylpropan-2-yl)-1H-indazole-3-carboximide
N/A
25.
1-(5-Fluoropentyl)-N-(2-phenylpropan-2-yl)-1H-pyrrolo[2,3-b]pyridine-3carboximide
N/A
25.
Cyclopropyl Fentanyl
N/A
20.
Fentanyl related substances
N/A
25.
Isobutyryl Fentanyl
N/A
25.
Methyl-2-(1-(cyclohexylmethyl)-1H-indole-3-carboxamido)-3-methylbutanoate
N/A
25.
N-(1-Amino-3-methyl-1-oxobutan-2-yl)-1-(5-fluoropentyl)-1H-indazole-3-carboxamide
N/A
25.
Naphthalen-1-yl 1-(5-fluorpentyl)-1H-indole-3-carboxylate
N/A
25.
Ocfentanil
N/A
25.
Para-flourobutyryl fentanyl
N/A
25.
Tetrahydrofuranyl fentanyl
N/A
5.
Valeryl fentanyl
N/A
25.
Schedule I
1-[1-(2-Thienyl)cyclohexyl]pyrrolidine
Zero
20.
1-(1-Phenylcyclohexyl)pyrrolidine
10
15.
1-(2-Phenylethyl)-4-phenyl-4-acetoxypiperidine
zero
10.
1-(5-Fluoropentyl)-3-(1-naphthoyl)indole (AM2201)
30
no change.
1-(5-Fluoropentyl)-3-(2-iodobenzoyl)indole (AM694)
30
no change.
1-[1-(2-Thienyl)cyclohexyl]piperidine
15
no change.
1-Benzylpiperazine
25
no change.
1-Methyl-4-phenyl-4-propionoxypiperidine
2
10.
2-(2,5-Dimethoxy-4-ethylphenyl)ethanamine (2C-E)
30
no change.
2-(2,5-Dimethoxy-4-methylphenyl)ethanamine (2C-D)
30
no change.
2-(2,5-Dimethoxy-4-nitro-phenyl)ethanamine (2C-N)
30
no change.
2-(2,5-Dimethoxy-4-n-propylphenyl)ethanamine (2C-P)
30
no change.
2-(2,5-Dimethoxyphenyl)ethanamine (2C-H)
30
no change.
2-(4-Bromo-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl)ethanamine (25B-NBOMe; 2C-B-NBOMe; 25B; Cimbi-36)
30
no change.
2-(4-Chloro-2,5-dimethoxyphenyl)ethanamine (2C-C)
30
no change.
2-(4-Chloro-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl)ethanamine (25C-NBOMe; 2C-C-NBOMe; 25C; Cimbi-82)
25
no change.
2-(4-Iodo-2,5-dimethoxyphenyl)ethanamine (2C-I)
30
no change.
2-(4-Iodo-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl)ethanamine (25I-NBOMe; 2C-I-NBOMe; 25I; Cimbi-5)
30
no change.
2,5-Dimethoxy-4-ethylamphetamine (DOET)
25
no change.
2,5-Dimethoxy-4-n-propylthiophenethylamine
25
no change.
2,5-Dimethoxyamphetamine
25
no change.
2-[4-(Ethylthio)-2,5-dimethoxyphenyl]ethanamine (2C-T-2)
30
no change.
2-[4-(Isopropylthio)-2,5-dimethoxyphenyl]ethanamine (2C-T-4)
30
no change.
3,4,5-Trimethoxyamphetamine
30
no change.
3,4-Methylenedioxyamphetamine (MDA)
55
no change.
3,4-Methylenedioxymethamphetamine (MDMA)
50
no change.
3,4-Methylenedioxy-N-ethylamphetamine (MDEA)
40
no change.
3,4-Methylenedioxy-N-methylcathinone (methylone)
40
no change.
3,4-Methylenedioxypyrovalerone (MDPV)
35
no change.
3-FMC; 3-Fluoro-N-methylcathinone
25
no change.
3-Methylfentanyl
30
no change.
3-Methylthiofentanyl
30
no change.
4-Bromo-2,5-dimethoxyamphetamine (DOB)
30
no change.
4-Bromo-2,5-dimethoxyphenethylamine (2-CB)
25
no change.
4-Fluoroisobutyryl fentanyl
30
no change.
4-FMC; Flephedrone
25
no change.
4-MEC; 4-Methyl-N-ethylcathinone
25
no change.
4-Methoxyamphetamine
150
no change.
4-Methyl-2,5-dimethoxyamphetamine (DOM)
25
no change.
4-Methylaminorex
25
no change.
4-Methyl-N-methylcathinone (mephedrone)
45
no change.
4-Methyl-α-pyrrolidinopropiophenone (4-MePPP)
25
no change.
5-(1,1-Dimethylheptyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-phenol
50
no change.
5-(1,1-Dimethyloctyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-phenol (cannabicyclohexanol or CP-47,497 C8-homolog)
40
no change.
5F-ADB; 5F-MDMB-PINACA (methyl 2-(1-(5-fluoropentyl)-1H-indazole-3-carboxamido)-3,3-dimethylbutanoate)
30
no change.
5F-AMB (methyl 2-(1-(5-fluoropentyl)-1H-indazole-3-carboxamido)-3-methylbutanoate)
30
no change.
5F-APINACA; 5F-AKB48 (N-(adamantan-1-yl)-1-(5-fluoropentyl)-1H-indazole-3-carboxamide)
30
no change.
5-Fluoro-PB-22; 5F-PB-22
20
no change.
5-Fluoro-UR144, XLR11 ([1-(5-fluoro-pentyl)-1
H
indol-
3-yl](2,2,3,3-tetramethylcyclopropyl)methanone
25
no change.
5-Methoxy-3,4-methylenedioxyamphetamine
25
no change.
5-Methoxy-N,N-diisopropyltryptamine
25
no change.
5-Methoxy-N,N-dimethyltryptamine
25
no change.
AB-CHMINACA
30
no change.
AB-FUBINACA
50
no change.
AB-PINACA
30
no change.
ADB-FUBINACA (N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-(4-fluorobenzyl)-1H-indazole-3-carboxamide)
30
no change.
Acetyl Fentanyl
100
no change.
Acetyl-
alpha
-methylfentanyl
30
no change.
Acetyldihydrocodeine
30
no change.
Acetylmethadol
2
no change.
Acryl Fentanyl
25
no change.
ADB-PINACA (
N
-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-pentyl-1
H
-indazole-3-carboxamide)
50
no change.
AH-7921
30
no change.
Allylprodine
2
no change.
Alphacetylmethadol
2
no change.
alpha-
Ethyltryptamine
25
no change.
Alphameprodine
2
no change.
Alphamethadol
2
no change.
alpha
-Methylfentanyl
30
no change.
alpha
-Methylthiofentanyl
30
no change.
alpha
-Methyltryptamine (AMT)
25
no change.
alpha
-Pyrrolidinobutiophenone (α-PBP)
25
no change.
alpha
-Pyrrolidinopentiophenone (α-PVP)
25
no change.
Aminorex
25
no change.
APINCA, AKB48 (
N
-(1-adamantyl)-1-pentyl-1
H
-indazole-3-carboxamide)
25
no change.
Benzylmorphine
30
no change.
Betacetylmethadol
2
no change.
beta
-Hydroxy-3-methylfentanyl
30
no change.
beta
-Hydroxyfentanyl
30
no change.
beta
-Hydroxythiofentanyl
30
no change.
Betameprodine
2
no change.
Betamethadol
4
no change.
Betaprodine
2
no change.
Bufotenine
3
no change.
Butylone
25
no change.
Butyryl fentanyl
30
no change.
Cathinone
24
no change.
Codeine methylbromide
30
no change.
Codeine-N-oxide
192
no change.
Desomorphine
25
no change.
Diapromide
Zero
20.
Diethylthiambutene
Zero
20.
Diethyltryptamine
25
no change.
Difenoxin
8,225
no change.
Dihydromorphine
1,000,160
no change.
Dimethyltryptamine
35
50.
Dipipanone
5
no change.
Etorphine
30
no change.
Fenethylline
30
no change.
Furanyl fentanyl
30
no change.
gamma
-Hydroxybutyric acid
37,130,000
no change.
Heroin
45
no change.
Hydromorphinol
40
no change.
Hydroxypethidine
2
no change.
Ibogaine
30
no change.
JWH-018 and AM678 (1-Pentyl-3-(1-naphthoyl)indole)
35
no change.
JWH-019 (1-Hexyl-3-(1-naphthoyl)indole)
45
no change.
JWH-073 (1-Butyl-3-(1-naphthoyl)indole)
45
no change.
JWH-081 (1-Pentyl-3-[1-(4-methoxynaphthoyl)]indole)
30
no change.
JWH-122 (1-Pentyl-3-(4-methyl-1-naphthoyl)indole)
30
no change.
JWH-200 (1-[2-(4-Morpholinyl)ethyl]-3-(1-naphthoyl)indole)
35
no change.
JWH-203 (1-Pentyl-3-(2-chlorophenylacetyl)indole)
30
no change.
JWH-250 (1-Pentyl-3-(2-methoxyphenylacetyl)indole)
30
no change.
JWH-398 (1-Pentyl-3-(4-chloro-1-naphthoyl)indole)
30
no change.
Lysergic acid diethylamide (LSD)
40
no change.
MAB-CHMINACA; ADB-CHMINACA (
N
-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-(cyclohexylmethyl)-1
H
-indazole-3-carboxamide)
30
no change.
MDMB-CHMICA; MMB-CHMINACA(methyl 2-(1-(cyclohexylmethyl)-1H-indole-3-carboxamido)-3,3-dimethylbutanoate)
30
no change.
MDMB-FUBINACA (methyl 2-(1-(4-fluorobenzyl)-1H-indazole-3-carboxamido)-3,3-dimethylbutanoate)
30
no change.
Marihuana
443,680
1,140,216.
Mecloqualone
30
no change.
Mescaline
25
no change.
Methaqualone
60
no change.
Methcathinone
25
no change.
Methyldesorphine
5
no change.
Methyldihydromorphine
2
no change.
Morphine methylbromide
5
no change.
Morphine methylsulfonate
5
no change.
Morphine-N-oxide
150
no change.
N,N
-Dimethylamphetamine
25
no change.
Naphyrone
25
no change.
N
-Ethyl-1-phenylcyclohexylamine
5
no change.
N-Ethyl-3-piperidyl benzilate
Zero
10.
N
-Ethylamphetamine
24
no change.
N
-Hydroxy-3,4-methylenedioxyamphetamine
24
no change.
Noracymethadol
2
no change.
Norlevorphanol
55
no change.
Normethadone
2
no change.
Normorphine
40
no change.
Para-fluorofentanyl
25
no change.
Parahexyl
5
no change.
PB-22; QUPIC
20
no change.
Pentedrone
25
no change.
Pentylone
25
no change.
Phenomorphan
2
no change.
Pholcodine
5
no change.
Psilocybin
30
no change.
Psilocyn
50
no change.
SR-18 and RCS-8 (1-Cyclohexylethyl-3-(2-methoxyphenylacetyl)indole)
45
no change.
SR-19 and RCS-4 (1-Pentyl-3-[(4-methoxy)-benzoyl]indole)
30
no change.
Tetrahydrocannabinols
384,460
no change.
Thiofentanyl
25
no change.
THJ-2201 ( [1-(5-fluoropentyl)-1H-indazol-3-yl](naphthalen-1-yl)methanone)
30
no change.
Tilidine
25
no change.
Trimeperidine
2
no change.
UR-144 (1-pentyl-1H-indol-3-yl)(2,2,3,3-tetramethylcyclopropyl)methanone
25
no change.
U-47700
30
no change.
Schedule II
1-Phenylcyclohexylamine
4
15.
1-Piperidinocyclohexanecarbonitrile
4
25.
4-Anilino-N-phenethyl-4-piperidine (ANPP)
1,342,320
no change.
Alfentanil
6,200
no change.
Alphaprodine
2
no change.
Amobarbital
20,100
no change.
Amphetamine (for conversion)
11,280,000
12,700,000.
Amphetamine (for sale)
39,856,000
no change.
Anileridine
Zero
20.
Carfentanil
20
no change.
Cocaine
92,120
no change.
Codeine (for conversion)
15,040,000
12,900,000.
Codeine (for sale)
40,015,000
no change.
Dextropropoxyphene
35
no change.
Dihydrocodeine
264,140
no change.
Dihydroetorphine
2
no change.
Diphenoxylate (for conversion)
14,100
no change.
Diphenoxylate (for sale)
770,800
no change.
Ecgonine
88,134
no change.
Ethylmorphine
30
no change.
Etorphine hydrochloride
32
no change.
Fentanyl
1,342,320
no change.
Glutethimide
2
no change.
Hydrocodone (for conversion)
114,680
no change.
Hydrocodone (for sale)
50,348,280
44,710,000.
Hydromorphone
4,547,720
no change.
Isomethadone
30
no change.
Levo-alphacetylmethadol (LAAM)
5
no change.
Levomethorphan
30
2,200.
Levorphanol
12,126
38,000.
Lisdexamfetamine
17,869,000
19,000,000.
Meperidine
2,717,540
1,913,148.
Meperidine Intermediate-A
5
30.
Meperidine Intermediate-B
30
no change.
Meperidine Intermediate-C
5
30.
Metazocine
15
no change.
Methadone (for sale)
22,278,000
no change.
Methadone Intermediate
24,064,000
no change.
Methamphetamine
1,446,754
no change.
[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
no change.
Morphine (for conversion)
4,089,000
no change.
Morphine (for sale)
33,958,440
31,456,000.
Nabilone
31,000
62,000.
Noroxymorphone (for conversion)
14,044,540
16,440,000.
Noroxymorphone (for sale)
376,000
no change.
Opium (powder)
84,600
no change.
Opium (tincture)
564,000
no change.
Oripavine
24,534,000
no change.
Oxycodone (for conversion)
2,453,400
no change.
Oxycodone (for sale)
95,692,000
85,578,000.
Oxymorphone (for conversion)
20,962,000
no change.
Oxymorphone (for sale)
3,395,280
3,137,240.
Pentobarbital
25,850,000
no change.
Phenazocine
5
no change.
Phencyclidine
35
no change.
Phenmetrazine
25
no change.
Phenylacetone
40
no change.
Racemethorphan
5
no change.
Racemorphan
5
no change.
Remifentanil
2,820
3,000.
Secobarbital
161,682
172,100.
Sufentanil
1,880
no change.
Tapentadol
18,388,280
no change.
Thebaine
94,000,000
86,200,000.
List I Chemicals
Ephedrine (for conversion)
47,000
no change.
Ephedrine (for sale)
4,136,000
no change.
Phenylpropanolamine (for conversion)
14,100,000
no change.
Phenylpropanolamine (for sale)
7,990,000
no change.
Pseudoephedrine (for conversion)
40
1,000.
Pseudoephedrine (for sale)
180,000,000
no change.
The Acting Administrator further proposes that aggregate production quotas for all other schedule I and II controlled substances included in 21 CFR 1308.11 and 1308.12 remain at zero. In accordance with 21 CFR 1303.13 and 21 CFR 1315.13, upon consideration of the relevant factors, the Acting Administrator may adjust the 2018 aggregate production quotas and assessment of annual needs as needed.
Conclusion
After consideration of any comments or objections, or after a hearing, if one is held, the Acting Administrator will issue and publish in the
Federal Register
a final order establishing any adjustment of 2018 aggregate production quotas for each basic class of controlled substances in schedules I and II and established assessment of annual needs for the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine, 21 CFR 1303.13(c) and 1315.13(f).
Dated: August 17, 2018.
Uttam Dhillon,
Acting Administrator.
[FR Doc. 2018-18265 Filed 8-22-18; 8:45 am]
BILLING CODE 4410-09-P
This is a copy of a public record, reproduced as it was published. It is not legal advice, and it may not be the version a court would rely on. Check the official source before you cite it.