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 2015
Federal RegisterJul 8, 2015
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-418P]
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 2015
AGENCY:
Drug Enforcement Administration, Department of Justice.
ACTION:
Notice with request for comments.
SUMMARY:
The Drug Enforcement Administration proposes to adjust the 2015 aggregate production quotas for several 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:
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 August 7, 2015. 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.
ADDRESSES:
To ensure proper handling of comments, please reference “Docket No. DEA-418P” 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/ODL, 8701 Morrissette Drive, Springfield, Virginia 22152.
FOR FURTHER INFORMATION CONTACT:
John R. Scherbenske, Office of Diversion Control, Drug Enforcement Administration, 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 and will be made available 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 posted online or made available in the public docket, 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 the confidential business information to be redacted within the comment. If a comment has so much confidential business information that it cannot be effectively redacted, all or part of that comment may not be made available in the public docket. Comments containing personal identifying information or confidential business information identified as directed above will be made publicly available in redacted form.
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 determine the total quantity and 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. This responsibility has been delegated to the Administrator of the DEA. 28 CFR 0.100(b).
The DEA established the 2015 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 September 8, 2014 (79 FR 53216). 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 2015 Aggregate Production Quotas and Assessment of Annual Needs
The DEA proposes to adjust the established 2015 aggregate production quotas for certain schedule I and II controlled substances to be manufactured in the United States in 2015 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 do not include imports of controlled substances for use in industrial processes. The DEA is not proposing to adjust the established 2015 assessment of annual needs for the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine to be manufactured in and imported into the United States in 2015 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.
In proposing the adjustment, the DEA has taken into account the criteria that the DEA is required to consider in accordance with 21 CFR 1303.13 and 21 CFR 1315.13. The DEA determines whether to propose an adjustment of the aggregate production quotas for basic classes of schedule I and II controlled substances and assessment of annual needs for ephedrine, pseudoephedrine,
and phenylpropanolamine 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.
The DEA also considered updated information obtained from 2014 year-end inventories, 2014 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 DEA 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 2015 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).
As previously described in the published notice establishing the 2015 aggregate production quotas and assessment of annual needs, the DEA has specifically considered that inventory allowances granted to individual manufacturers, 21 CFR 1303.24, may not always result in the availability of sufficient quantities to maintain an adequate reserve stock pursuant to 21 U.S.C. 826(a), as intended. This would be concerning if a natural disaster or other unforeseen event resulted in substantial disruption to the amount of controlled substances available to provide for legitimate public need. As such, the DEA has included in all proposed adjusted schedule II controlled substance aggregate production quotas, and certain proposed adjusted schedule I controlled substance aggregate production quotas, an additional 25% of the estimated medical, scientific, and research needs as part of the amount necessary to ensure the establishment and maintenance of reserve stocks. The resulting adjusted established aggregate production quotas will reflect these included amounts. This action will not affect the ability of manufacturers to maintain inventory allowances as specified by regulation. The DEA expects that maintaining this reserve in certain established aggregate production quotas will mitigate adverse public effects if an unforeseen event results in substantial disruption to the amount of controlled substances available to provide for legitimate public need, as determined by the DEA. The DEA does not anticipate utilizing the reserve in the absence of these circumstances.
The Acting Administrator, therefore, proposes to adjust the 2015 aggregate production quotas for certain schedule I and II controlled substances expressed in grams of anhydrous acid or base, as follows:
Basic class
Established
2015 Quotas
(g)
Proposed
Adjusted 2015
Quotas
(g)
Schedule I
(1-Pentyl-1
H
-indol-3-yl)(2,2,3,3-tetramethylcyclopropyl)methanone (UR-144)
15
25
[1-(5-Fluoro-pentyl)-1
H
-indol-3-yl](2,2,3,3-tetramethylcyclopropyl)methanone (XLR11)
15
25
[1-(5-fluoropentyl)-1
H
-indazol-3-yl](naphthalen-1-yl)methanone (THJ-2201)
15
no change
1-(1,3-Benzodioxol-5-yl)-2-(methylamino)butan-1-one (butylone)
15
25
1-(1,3-Benzodioxol-5-yl)-2-(methylamino)pentan-1-one (pentylone)
15
25
1-(1-Phenylcyclohexyl)pyrrolidine
10
no change
1-(5-Fluoropentyl)-3-(1-naphthoyl)indole (AM2201)
45
no change
1-(5-Fluoropentyl)-3-(2-iodobenzoyl)indole (AM694)
45
no change
1-[1-(2-Thienyl)cyclohexyl]piperidine
15
no change
1-[2-(4-Morpholinyl)ethyl]-3-(1-naphthoyl)indole (JWH-200)
45
no change
1-Butyl-3-(1-naphthoyl)indole (JWH-073)
45
no change
1-Cyclohexylethyl-3-(2-methoxyphenylacetyl)indole (SR-18 and RCS-8)
45
no change
1-Hexyl-3-(1-naphthoyl)indole (JWH-019)
45
no change
1-Methyl-4-phenyl-4-propionoxypiperidine
2
no change
1-Pentyl-3-(1-naphthoyl)indole (JWH-018 and AM678)
45
no change
1-Pentyl-3-(2-chlorophenylacetyl)indole (JWH-203)
45
no change
1-Pentyl-3-(2-methoxyphenylacetyl)indole (JWH-250)
45
no change
1-Pentyl-3-(4-chloro-1-naphthoyl)indole (JWH-398)
45
no change
1-Pentyl-3-(4-methyl-1-naphthoyl)indole (JWH-122)
45
no change
1-Pentyl-3-[(4-methoxy)-benzoyl]indole (SR-19, RCS-4)
45
no change
1-Pentyl-3-[1-(4-methoxynaphthoyl)]indole (JWH-081)
45
no change
2-(2,5-Dimethoxy-4-
n
-propylphenyl)ethanamine (2C-P)
30
no change
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-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)
15
25
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)
15
25
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)
15
no change
2-(Methylamino)-1-phenylpentan-1-one (pentedrone)
15
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
25
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)
50
no change
3,4-Methylenedioxypyrovalerone (MDPV)
35
no change
3-Fluoro-
N
-methylcathinone (3-FMC)
15
25
3-Methylfentanyl
2
no change
3-Methylthiofentanyl
2
no change
4-Bromo-2,5-dimethoxyamphetamine (DOB)
25
no change
4-Bromo-2,5-dimethoxyphenethylamine (2-CB)
25
no change
4-Fluoro-
N
-methylcathinone (4-FMC)
15
25
4-Methoxyamphetamine
100
no change
4-Methyl-2,5-dimethoxyamphetamine (DOM)
25
no change
4-Methylaminorex
25
no change
4-Methyl-
N
-ethylcathinone (4-MEC)
15
25
4-Methyl-
N
-methylcathinone (mephedrone)
45
no change
4-Methyl-α-pyrrolidinopropiophenone (4-MePPP)
15
25
5-(1,1-Dimethylheptyl)-2-[(1
R,
3
S
)-3-hydroxycyclohexyl]-phenol
68
no change
5-(1,1-Dimethyloctyl)-2-[(1
R,
3
S
)-3-hydroxycyclohexyl]-phenol (cannabicyclohexanol or CP-47,497 C8-homolog)
53
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
Acetyl-
alpha
-methylfentanyl
2
no change
Acetyldihydrocodeine
2
no change
Acetylmethadol
2
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
2
no change
alpha
-Methylthiofentanyl
2
no change
alpha
-Methyltryptamine (AMT)
25
no change
alpha
-Pyrrolidinobutiophenone (α-PBP)
15
25
alpha
-Pyrrolidinopentiophenone (α-PVP)
15
25
Aminorex
25
no change
Benzylmorphine
2
no change
Betacetylmethadol
2
no change
beta
-Hydroxy-3-methylfentanyl
2
no change
beta
-Hydroxyfentanyl
2
no change
Betameprodine
2
no change
Betamethadol
4
no change
Betaprodine
2
no change
Bufotenine
3
no change
Cathinone
70
no change
Codeine methylbromide
5
no change
Codeine-
N
-oxide
305
no change
Desomorphine
5
25
Diethyltryptamine
25
no change
Difenoxin
11,000
no change
Dihydromorphine
3,990,000
no change
Dimethyltryptamine
35
no change
Dipipanone
5
no change
Fenethylline
5
no change
gamma
-Hydroxybutyric acid
70,250,000
no change
Heroin
25
50
Hydromorphinol
2
no change
Hydroxypethidine
2
no change
Ibogaine
5
no change
Lysergic acid diethylamide (LSD)
35
no change
Marihuana
658,000
no change
Mescaline
25
no change
Methaqualone
10
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
350
no change
N
-(1-Adamantyl)-1-pentyl-1
H
-indazole-3-carboxamide (AKB48)
15
25
N
-(1-Amino-3,3-dimethyl-1-oxobutan-2-yl)-1-pentyl-1
H
-indazole-3-carboxamide (ADB-PINACA)
15
25
N
-(1-Amino-3-methyl-1-oxobutan-2-yl)-1-(4-fluorobenzyl)-1
H
-indazole-3-carboxamide (AB-FUBINACA)
15
25
N
-(1-Amino-3-methyl-1-oxobutan-2-yl)-1-(cyclohexylmethyl)-1
H
-indazole-3-carboxamide (AB-CHMINACA)
15
no change
N
-(1-Amino-3-methyl-1-oxobutan-2-yl)-1-pentyl-1
H
-indazole-3-carboxamide (AB-PINACA)
15
no change
N,N
-Dimethylamphetamine
25
no change
Naphthylpyrovalerone (naphyrone)
15
25
N
-Benzylpiperazine
25
no change
N
-Ethyl-1-phenylcyclohexylamine
5
no change
N
-Ethylamphetamine
24
no change
N
-Hydroxy-3,4-methylenedioxyamphetamine
24
no change
Noracymethadol
2
no change
Norlevorphanol
52
no change
Normethadone
2
no change
Normorphine
18
40
Para-fluorofentanyl
zero
5
Parahexyl
zero
5
Phenomorphan
2
no change
Pholcodine
zero
5
Psilocybin
30
no change
Psilocyn
30
no change
Quinolin-8-yl 1-(5-fluoropentyl)-1
H
-indole-3-carboxylate (5-fluoro-PB-22; 5F-PB-22)
15
25
Quinolin-8-yl 1-pentyl-1
H
-indole-3-carboxylate (PB-22; QUPIC)
15
25
Tetrahydrocannabinols
497,500
511,250
Thiofentanyl
2
no change
Tilidine
10
25
Trimeperidine
2
no change
Schedule II
1-Phenylcyclohexylamine
5
no change
1-Piperidinocyclohexanecarbonitrile
5
no change
4-Anilino-
N
-phenethyl-4-piperidine (ANPP)
2,687,500
no change
Alfentanil
17,750
no change
Alphaprodine
3
no change
Amobarbital
25,125
no change
Amphetamine (for conversion)
21,875,000
no change
Amphetamine (for sale)
37,500,000
no change
Carfentanil
19
no change
Cocaine
275,000
no change
Codeine (for conversion)
50,000,000
no change
Codeine (for sale)
49,500,000
63,900,000
Dextropropoxyphene
19
45
Dihydrocodeine
226,375
no change
Diphenoxylate (for conversion)
75,000
no change
Diphenoxylate (for sale)
1,337,500
no change
Ecgonine
174,375
no change
Ethylmorphine
3
no change
Fentanyl
2,150,000
2,300,000
Glutethimide
3
no change
Hydrocodone (for conversion)
137,500
no change
Hydrocodone (for sale)
99,625,000
no change
Hydromorphone
7,000,000
no change
Isomethadone
5
no change
Levo-alphacetylmethadol (LAAM)
4
no change
Levomethorphan
5
30
Levorphanol
7,125
no change
Lisdexamfetamine
29,750,000
no change
Meperidine
6,250,000
no change
Meperidine Intermediate-A
6
no change
Meperidine Intermediate-B
11
32
Meperidine Intermediate-C
6
no change
Metazocine
19
no change
Methadone (for sale)
31,875,000
no change
Methadone Intermediate
34,375,000
no change
Methamphetamine
2,061,375
no change
[1,250,000 grams of
levo
-desoxyephedrine for use in a non-controlled, non-prescription product; 750,000 grams for methamphetamine mostly for conversion to a schedule III product; and 61,375 grams for methamphetamine (for sale)]
Methylphenidate
83,750,000
87,500,000
Morphine (for conversion)
91,250,000
no change
Morphine (for sale)
62,500,000
no change
Nabilone
18,750
no change
Noroxymorphone (for conversion)
17,500,000
no change
Noroxymorphone (for sale)
1,475,000
no change
Opium (powder)
112,500
no change
Opium (tincture)
687,500
no change
Oripavine
35,000,000
no change
Oxycodone (for conversion)
8,350,000
no change
Oxycodone (for sale)
137,500,000
139,150,000
Oxymorphone (for conversion)
29,000,000
no change
Oxymorphone (for sale)
7,750,000
no change
Pentobarbital
35,000,000
no change
Phenazocine
6
no change
Phencyclidine
19
38
Phenmetrazine
3
no change
Phenylacetone
9,375,000
no change
Racemethorphan
3
no change
Remifentanil
3,750
4,200
Secobarbital
215,003
no change
Sufentanil
6,255
no change
Tapentadol
12,500,000
no change
Thebaine
125,000,000
no change
List I Chemicals
Ephedrine (for conversion)
1,000,000
no change
Ephedrine (for sale)
4,000,000
no change
Phenylpropanolamine (for conversion)
44,800,000
no change
Phenylpropanolamine (for sale)
8,500,000
no change
Pseudoephedrine (for conversion)
7,000
no change
Pseudoephedrine (for sale)
224,500,000
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 further adjust the 2015 aggregate production quotas and assessment of annual needs as needed.
Comments
In accordance with 21 CFR 1303.13(c) and 1315.13(d), any interested person may submit written comments on or objections to these proposed determinations. Based on comments received in response to this notice, the Acting Administrator may hold a public hearing on one or more issues raised. 21 CFR 1303.13(c) and 1315.13(e). In the event the Acting Administrator decides to hold such a hearing, the Acting Administrator will publish a notice of the hearing in the
Federal Register
. 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 the 2015 aggregate production quota for each basic class of controlled substance 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: July 1, 2015.
Chuck Rosenberg,
Acting Administrator.
[FR Doc. 2015-16699 Filed 7-7-15; 8:45 am]
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