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 2023
Federal RegisterOct 31, 2023
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-1051A]
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 2023
AGENCY:
Drug Enforcement Administration, Department of Justice.
ACTION:
Notice with request for comments.
SUMMARY:
The Drug Enforcement Administration (DEA) proposes to adjust the 2023 aggregate production quotas for several controlled substances in schedules I and II of the Controlled Substances Act (CSA) and the assessment of annual needs for the list I chemical 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 November 30, 2023. 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 her 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 2023 adjusted aggregate production quotas for schedule I and II controlled substances, and an adjusted assessment of annual needs for the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine, as relevant.
ADDRESSES:
To ensure proper handling of comments, please reference “Docket No. DEA-1051A” on all correspondence, including any attachments. DEA 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:
Scott A. Brinks, Regulatory Drafting and Policy Support Section, Diversion Control Division, Drug Enforcement Administration; Mailing Address: 8701 Morrissette Drive, Springfield, Virginia 22152, Telephone: 571-776-3882.
SUPPLEMENTARY INFORMATION:
Posting of Public Comments
Please note that all comments received in response to this docket are considered part of the public record. The Drug Enforcement Administration (DEA) will make comments available for public inspection online at
http://www.regulations.gov.
Such information includes personal or business identifiers (such as name, address, state or Federal identifiers, etc.) voluntarily submitted by the commenter. Generally, all information voluntarily submitted by the commenter, unless clearly marked as Confidential Information in the method described below, will be publicly posted. Comments may be submitted anonymously. The Freedom of Information Act applies to all comments received.
Commenters submitting comments which include personal identifying information (PII), confidential, or proprietary business information that the commenter does not want made publicly available should submit two copies of the comment. One copy must be marked “CONTAINS CONFIDENTIAL INFORMATION” and should clearly identify all PII or business information the commenter does not want to be made publicly available, including any supplemental materials. DEA will review this copy, including the claimed PII and confidential business information, in its consideration of comments. The second copy should be marked “TO BE PUBLICLY POSTED” and must have all claimed confidential PII and business information already redacted. DEA will post only the redacted comment on
http://www.regulations.gov for public inspection.
For easy reference, an electronic copy of this document is available at
http://www.regulations.gov.
Legal Authority and Background
Section 306 of the CSA (21 U.S.C. 826) requires the Attorney General to establish aggregate production quotas (APQ) 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 DEA.
1
1
28 CFR 0.100(b).
DEA established the 2023 APQ for substances in schedules I and II and the assessment of annual needs (AAN) for the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine on December 2, 2022.
2
That order stipulated that, in accordance with 21 CFR 1303.13 and 1315.13, all APQ and AAN are subject to adjustment.
2
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 2023, 87 FR 74168 (December 2, 2022).
Analysis for Proposed Adjusted 2023 Aggregate Production Quotas and Assessment of Annual Needs
DEA proposes to adjust the established 2023 APQ for certain schedule I and II controlled substances and the AAN for certain list I chemicals to be manufactured in the United States (U.S.) in 2023 to provide for the estimated medical, scientific, research, and industrial needs of the U.S., 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.
Factors for Determining the Proposed Adjustments
In determining the proposed adjustments, the Administrator has taken into account the factors in 21 CFR 1303.13 (adjustment of APQ for controlled substances) and 21 CFR 1315.13 (adjustment of the AAN for ephedrine, pseudoephedrine, and phenylpropanolamine). The Administrator is authorized to increase or reduce the APQ and the AAN at any time.
3
3
21 CFR 1303.13(a) and 1315.13(a).
DEA determined whether to propose an adjustment of the APQ for 2023 by considering the factors found at 21 CFR 1303.13(b):
4
4
DEA recently adopted revisions to its regulations for setting quotas, but that rule has not yet taken effect and does not affect this notice proposing some adjustments to the 2023 APQs. Management of Quotas for Controlled Substances and List I Chemicals, 88 FR 60117 (Aug. 31, 2023) (effective Nov. 29, 2023).
(1) Changes in the demand for that class, changes in the national rate of net disposal of the class, changes in the rate of net disposal of the class by registrants holding individual manufacturing quotas for that class, and changes in the extent of any diversion in the class;
(2) Whether any increased demand for that class, the national and/or individual rates of net disposal of that class are temporary, short term, or long term;
(3) Whether any increased demand for that class can be met through existing inventories, increased individual manufacturing quotas, or increased importation, without increasing the aggregate production quota, taking into account production delays and the probability that other individual manufacturing quotas may be suspended pursuant to Sec. 1303.24(b);
(4) Whether any decreased demand for that class will result in excessive inventory accumulation by all persons registered to handle that class (including manufacturers, distributors, practitioners, importers, and
exporters), notwithstanding the possibility that individual manufacturing quotas may be suspended pursuant to Sec. 1303.24(b) or abandoned pursuant to Sec. 1303.27;
(5) Other factors affecting medical, scientific, research, and industrial needs in the United States and lawful export requirements, as the Administrator finds relevant, including changes in the currently accepted medical use in treatment with the class or the substances which are manufactured from it, the economic and physical availability of raw materials for use in manufacturing and for inventory purposes, yield and stability problems, potential disruptions to production (including possible labor strikes), and recent unforeseen emergencies such as floods and fires.
DEA also considered updated information obtained from 2022 year-end inventories, 2022 disposition data submitted by quota applicants, changes in estimates of the medical needs of the U.S., export requirements, and other information made available to DEA after the initial APQ and AAN had been established. Additional factors the Administrator considered in calculating the APQ, but not the AAN, include product development requirements of both bulk and finished dosage form manufacturers.
After considering the changes in the extent of diversion of all controlled substances, as required by 21 CFR 1303.13(b)(1), DEA has determined that any changes from the initial calculations are slight and not statistically significant from the estimates of diversion that DEA applied to the initial APQ valuations.
DEA determined whether to propose an adjustment of the AAN for 2023 by considering the factors found at 21 CFR 1315.13(b) and summarized below:
(1) Changes in the demand for that chemical, changes in the national rate of net disposal of the chemical, and changes in the rate of net disposal of the chemical by registrants holding individual manufacturing or import quotas for that chemical;
(2) Whether any increased demand for that chemical, the national and/or changes in individual rates of net disposal of that chemical are temporary, short term, or long term;
(3) Whether any increased demand for that chemical can be met through existing inventories, increased individual manufacturing quotas, or increased importation, without increasing the assessment of annual needs, taking into account production delays and the probability that other individual manufacturing quotas may be suspended pursuant to Sec. 1315.24(b);
(4) Whether any decreased demand for that chemical will result in excessive inventory accumulation by all persons registered to handle that chemical (including manufacturers, distributors, importers, and exporters), notwithstanding the possibility that individual manufacturing quotas may be suspended pursuant to Sec. 1315.24(b) or abandoned pursuant to Sec. 1315.27;
(5) Other factors affecting medical, scientific, research, industrial, and importation needs in the United States, lawful export requirements, and reserve stocks, as the Administrator finds relevant, including changes in the currently accepted medical use in treatment with the chemical or the substances that are manufactured from it, the economic and physical availability of raw materials for use in manufacturing and for inventory purposes, yield and stability problems, potential disruptions to production (including possible labor strikes), and recent unforeseen emergencies such as floods and fires.
In evaluating whether there is a need for adjustment of the 2023 AAN for list I chemicals, DEA used the calculation methodology previously described in the 2010 and 2011 assessment of annual needs.
5
DEA considered the total net disposals of the list I chemicals for the current and preceding two years, actual and estimated inventories, projected demand, industrial use, and export requirements from data provided by DEA registered manufacturers and importers on the relevant quota application forms.
6
5
74 FR 60294 (Nov. 20, 2009) and 75 FR 79407 (Dec. 20, 2010).
6
Id.
Additional Considerations Applicable to Covered Controlled Substances
When setting APQ, the Administrator must estimate the amount of diversion of any substance that is considered a “covered controlled substance.”
7
The covered controlled substances are fentanyl, oxycodone, hydrocodone, oxymorphone, and hydromorphone.
8
DEA is required to “make appropriate quota reductions, as determined by the [Administrator], from the quota the [Administrator] would have otherwise established had such diversion not been considered.”
9
When estimating diversion, the Administrator “shall consider information,” in consultation with the Secretary of Health and Human Services, the Administrator “determines reliable on rates of overdose deaths and abuse and overall public health impact related to the covered controlled substance in the United States;” and “may take into consideration” whatever other sources of information they determine reliable.
10
7
21 U.S.C. 826(i)(1)(A).
8
21 U.S.C. 826(i)(1)(A).
9
All functions vested in the Attorney General by the CSA have been delegated to the Administrator of DEA. 28 CFR 0.100(b); 21 U.S.C. 826(i)(1)(C).
10
21 U.S.C. 826(i)(1)(B).
DEA sent letters to the Centers for Disease Control and Prevention (CDC), and the states in February, April, and May 2023 requesting overdose death and overprescribing data that could be considered in estimating diversion. DEA received information from the CDC in April 2023 and received Prescription Data Monitoring Program (PDMP) data from the states in May and June 2023. DEA considered this information in developing the estimates of diversion for the five covered controlled substances for this proposed adjustment.
To determine the estimates of diversion, DEA also aggregated data for each covered controlled substance from the Drug Theft and Loss Reports. DEA gathered data involving employee theft, break-ins, armed robberies, and material lost in transit. DEA calculated the metric weight in grams of each active pharmaceutical ingredient (API) of the controlled substances being diverted as identified in these reports. In calculating the estimates of diversion, DEA utilized the same methodology as published in the Proposed APQ for Schedule I and II Controlled Substances and AAN for the List I Chemicals Ephedrine, Pseudoephedrine, and Phenylpropanolamine for 2023.
11
Below, DEA provides an updated chart showing estimations of diversion for each of the covered controlled substances.
11
87 FR 63091 (October 18, 2022).
Diversion Estimates for 2023 (
g
)
Fentanyl
59
Hydrocodone
133,004
Hydromorphone
595
Oxycodone
174,797
Oxymorphone
109
Proposed Adjustments for the 2023 Aggregate Production Quotas and Assessment of Annual Needs
DEA is proposing increases to the APQ for the following schedule I substances: all other tetrahydrocannabinol, delta-9-tetrahydrocannabinol, ibogaine, psilocybin, and psilocyn. These proposed increases are to support research and clinical trials by DEA-registered schedule I researchers. These proposed increases demonstrate DEA's support for research with schedule I controlled substances.
DEA established the 2023 APQs for substances in schedules I and II on December 2, 2022.
12
Subsequent to that publication, DEA published in the
Federal Register
final rules to permanently schedule four synthetic
drugs under the CSA.
13
The specific synthetic substances are eutylone, mesocarb, methiopropamine, and zipeprol. As a result, these substances will continue to be subject to the CSA schedule I controls and DEA is proposing to assign individual APQ for each substance pursuant to 21 U.S.C. 826 and 21 CFR part 1303.
12
87 FR 74168.
13
87 FR 70717 (November 21, 2022), 87 FR 71247 (November 22, 2022), 87 FR 20318 (April, 7 2022), and 87 FR 32996 (June 1, 2022).
DEA previously adjusted the established 2023 aggregate production quota for the schedule II-controlled substance methylphenidate (for sale) to be manufactured in the United States to provide for the estimated needs of the United States and export requirements in accordance with 21 U.S.C. 826(h).
14
This adjustment was necessary to ensure that the United States has an adequate and uninterrupted supply of methylphenidate (for sale) to meet legitimate patient needs both domestically and globally.
14
Adjustment to the Aggregate Production Quota for Methylphenidate (for Sale) for 2023, 88 FR 68147 (October 3, 2023).
The Administrator, therefore, proposes to adjust the 2023 APQ for the schedule I controlled substances of all other tetrahydrocannabinol, delta-9-tetrahydrocannabinol, eutylone, ibogaine, mesocarb, methiopropamine, psilocybin, psilocyn, and zipeprol. The proposed adjusted APQ and AAN, as expressed in grams of anhydrous acid or base, are as follows:
Basic class
Established
2023 quotas
(g)
Proposed revised
2023 quotas
(g)
Schedule I
1-[1-(2-Thienyl)cyclohexyl]pyrrolidine
20
no change.
1-(1-Phenylcyclohexyl)pyrrolidine
30
no change.
1-(2-Phenylethyl)-4-phenyl-4-acetoxypiperidine
10
no change.
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.
2′-fluoro 2-fluorofentanyl
30
no change.
1-Benzylpiperazine
25
no change.
1-Methyl-4-phenyl-4-propionoxypiperidine
10
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-Dimethoxy-4-n-propylphenyl)ethanamine (2C-P)
30
no change.
2-(2,5-Dimethoxyphenyl)ethanamine (2C-H)
100
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)
12,000
no change.
3,4-Methylenedioxymethamphetamine (MDMA)
12,000
no change.
3,4-Methylenedioxy-N-ethylamphetamine (MDEA)
40
no change.
3,4-Methylenedioxy-N-methylcathinone (methylone)
5,200
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)
5,100
no change.
4-Bromo-2,5-dimethoxyphenethylamine (2-CB)
25
no change.
4-Chloro-
alpha
-pyrrolidinovalerophenone (4-chloro-
alpha
-PVP)
25
no change.
4-CN-Cumyl-Butinaca
25
no change.
4,4′-Dimethylaminorex
30
no change.
4-Fluoroisobutyryl fentanyl
30
no change.
4F-MDMB-BINACA
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-
alpha
-ethylaminopentiophenone (4-MEAP)
25
no change.
4-Methyl-
alpha
-pyrrolidinohexiophenone (MPHP)
25
no change.
4′-Methyl acetyl fentanyl
30
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-AB-PINACA; (1-Amino-3-methyl-1-oxobutan-2-yl)-1-(5-fluoropentyl)-1H-indazole-3-carboxamide
25
no change.
5F-ADB; 5F-MDMB-PINACA (methyl 2-(1-(5-fluoropentyl)-1H-indazole-3-carboxamido)-3,3-dimethylbutanoate)
25
no change.
5F-CUMYL-P7AICA; 1-(5-Fluoropentyl)-N-(2-phenylpropan-2-yl)-1H-pyrrolo[2,3-b]pyridine-3carboximide
25
no change.
5F-CUMYL-PINACA
25
no change.
5F-EDMB-PINACA
25
no change.
5F-MDMB-PICA
25
no change.
5F-AMB (methyl 2-(1-(5-fluoropentyl)-1H-indazole-3-carboxamido)-3-methylbutanoate)
25
no change.
5F-APINACA; 5F-AKB48 (N-(adamantan-1-yl)-1-(5-fluoropentyl)-1H-indazole-3-carboxamide)
25
no change.
5-Fluoro-PB-22; 5F-PB-22
25
no change.
5-Fluoro-UR144, XLR11 ([1-(5-fluoro-pentyl)-1Hindol-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
11,000
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.
Acetorphine
25
no change.
Acetyl Fentanyl
100
no change.
Acetyl-
alpha
-methylfentanyl
30
no change.
Acetyldihydrocodeine
30
no change.
Acetylmethadol
25
no change.
Acryl Fentanyl
25
no change.
ADB-PINACA (N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-pentyl-1H-indazole-3-carboxamide)
50
no change.
AH-7921
30
no change.
All other tetrahydrocannabinol
15,000
350,000.
Allylprodine
25
no change.
Alphacetylmethadol
25
no change.
alpha
-Ethyltryptamine
25
no change.
Alphameprodine
25
no change.
Alphamethadol
25
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
-pyrrolidinoheptaphenone (PV8)
25
no change.
alpha
-pyrrolidinohexabophenone (α -PHP)
25
no change.
alpha
-Pyrrolidinopentiophenone (α-PVP)
25
no change.
Amineptine
30
no change.
Aminorex
25
no change.
Anileridine
20
no change.
APINCA, AKB48 (N-(1-adamantyl)-1-pentyl-1H-indazole-3-carboxamide)
25
no change.
Benzethidine
25
no change.
Benzylmorphine
30
no change.
Betacetylmethadol
25
no change.
beta
-Hydroxy-3-methylfentanyl
30
no change.
beta
-Hydroxyfentanyl
30
no change.
beta
-Hydroxythiofentanyl
30
no change.
beta
-Methyl fentanyl
30
no change.
beta
-Phenyl fentanyl
30
no change.
Betameprodine
25
no change.
Betamethadol
4
no change.
Betaprodine
25
no change.
Brorphine
30
no change.
Bufotenine
15
no change.
Butonitazene
30
no change.
Butylone
25
no change.
Butyryl fentanyl
30
no change.
Cathinone
40
no change.
Clonitazene
25
no change.
Codeine methylbromide
30
no change.
Codeine-N-oxide
192
no change.
Crotonyl Fentanyl
25
no change.
Cyclopentyl Fentanyl
30
no change.
Cyclopropyl Fentanyl
20
no change.
Cyprenorphine
25
no change.
d-9-THC
384,460
628,460.
Desomorphine
25
no change.
Dextromoramide
25
no change.
Diapromide
20
no change.
Diethylthiambutene
20
no change.
Diethyltryptamine
25
no change.
Difenoxin
9,300
no change.
Dihydromorphine
653,548
no change.
Dimenoxadol
25
no change.
Dimepheptanol
25
no change.
Dimethylthiambutene
20
no change.
Dimethyltryptamine
3,000
no change.
Dioxyaphetyl butyrate
25
no change.
Dipipanone
25
no change.
Drotebanol
25
no change.
Ethylmethylthiambutene
25
no change.
Ethylone
25
no change.
Etonitazene
25
no change.
Etodesnitazene
30
no change.
Etorphine
30
no change.
Etoxeridine
25
no change.
Eutylone
N/A
30.
Fenethylline
30
no change.
Fentanyl carbamate
30
no change.
Fentanyl related substances
600
no change.
FUB-144
25
no change.
Flunitazene
30
no change.
FUB-AKB48
25
no change.
Fub-AMB, MMB-Fubinaca, AMB-Fubinaca
25
no change.
Furanyl fentanyl
30
no change.
Furethidine
25
no change.
gamma
-Hydroxybutyric acid
29,417,000
no change.
Heroin
150
no change.
Hydromorphinol
40
no change.
Hydroxypethidine
25
no change.
Ibogaine
30
150.
Isobutyryl Fentanyl
25
no change.
Isotonitazine
25
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.
Ketobemidone
30
no change.
Levomoramide
25
no change.
Levophenyacylmorphan
25
no change.
Lysergic acid diethylamide (LSD)
1,200
no change.
MAB-CHMINACA; ADB-CHMINACA (N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-(cyclohexylmethyl)-1H-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.
MMB-CHMICA-(AMB-CHIMCA); Methyl-2-(1-(cyclohexylmethyl)-1H-indole-3-carboxamido)-3-methylbutanoate
25
no change.
Marijuana
6,675,000
no change.
Marijuana extract
1,000,000
no change.
Mecloqualone
30
no change.
Mescaline
1,200
no change.
Mesocarb
N/A
30.
Methaqualone
60
no change.
Methcathinone
25
no change.
Methiopropamine
N/A
30.
Methoxetamine
30
no change.
Methoxyacetyl fentanyl
30
no change.
Methyldesorphine
5
no change.
Methyldihydromorphine
25
no change.
Metodesnitazene
30
no change.
Metonitazene
30
no change.
Morpheridine
25
no change.
Morphine methylbromide
5
no change.
Morphine methylsulfonate
5
no change.
Morphine-N-oxide
150
no change.
MT-45
30
no change.
Myrophine
25
no change.
NM2201: Naphthalen-1-yl 1-(5-fluorpentyl)-1H-indole-3-carboxylate
25
no change.
N,N-Dimethylamphetamine
25
no change.
Naphyrone
25
no change.
N-Ethyl-1-phenylcyclohexylamine
25
no change.
N-Ethyl-3-piperidyl benzilate
10
no change.
N-Ethylamphetamine
24
no change.
N-Ethylhexedrone
25
no change.
N-Ethylpentylone, ephylone
30
no change.
N-Hydroxy-3,4-methylenedioxyamphetamine
24
no change.
Nicocodeine
25
no change.
Nicomorphine
25
no change.
N-methyl-3-piperidyl benzilate
30
no change.
Noracymethadol
25
no change.
N-Pyrrolidino Etonitazene
30
no change.
Norlevorphanol
2,550
no change.
Normethadone
25
no change.
Normorphine
40
no change.
Norpipanone
25
no change.
Ocfentanil
25
no change.
ortho
-Fluoroacryl fentanyl
30
no change.
ortho
-Fluorobutyryl fentanyl
30
no change.
ortho
-Fluorofentanyl,2-Fluorofentanyl
30
no change.
ortho
-Fluoroisobutyryl fentanyl
30
no change.
ortho
-Methyl acetylfentanyl
30
no change.
ortho
-Methyl methoxyacetyl fentanyl
30
no change.
Para
-Chlorisobutyrl fentanyl
30
no change.
Para
-flourobutyryl fentanyl
25
no change.
Para
-fluorofentanyl
25
no change.
Para
-Fluoro furanyl fentanyl
30
no change.
Para
-Methoxybutyrl fentanyl
30
no change.
Para
-methoxymethamphetamine
30
no change.
Para
-Methylfentanyl
30
no change.
Parahexyl
5
no change.
PB-22; QUPIC
20
no change.
Pentedrone
25
no change.
Pentylone
25
no change.
Phenadoxone
25
no change.
Phenampromide
25
no change.
Phenomorphan
25
no change.
Phenoperidine
25
no change.
Phenyl fentanyl
30
no change.
Pholcodine
5
no change.
Piritramide
25
no change.
Proheptazine
25
no change.
Properidine
25
no change.
Propiram
25
no change.
Protonitazene
30
no change.
Psilocybin
8,000
15,000.
Psilocyn
12,000
24,000.
Racemoramide
25
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.
Tetrahydrofuranyl fentanyl
15
no change.
Thebacon
25
no change.
Thiafentanil
25
no change.
Thiofentanyl
25
no change.
Thiofuranyl fentanyl
30
no change.
THJ-2201 ([1-(5-fluoropentyl)-1H-indazol-3-yl](naphthalen-1-yl)methanone)
30
no change.
Tilidine
25
no change.
Trimeperidine
25
no change.
UR-144 (1-pentyl-1H-indol-3-yl)(2,2,3,3-tetramethylcyclopropyl)methanone
25
no change.
U-47700
30
no change.
Valeryl fentanyl
25
no change.
Zipeprol
N/A
30.
Schedule II
1-Phenylcyclohexylamine
15
no change.
1-Piperidinocyclohexanecarbonitrile
25
no change.
4-Anilino-N-phenethyl-4-piperidine (ANPP)
937,874
no change.
Alfentanil
5,000
no change.
Alphaprodine
25
no change.
Amobarbital
20,100
no change.
Amphetamine (for sale)(split)
N/A
no change.
Bezitramide
25
no change.
Carfentanil
20
no change.
Cocaine
60,492
no change.
Codeine (for conversion)
1,085,024
no change.
Codeine (for sale)
21,003,397
no change.
D-amphetamine (for sale)
21,200,000
no change.
D,l-amphetamine
21,200,000
no change.
D-amphetamine (for conversion)
20,000,000
no change.
Dexmethylphenidate (for sale)
6,200,000
no change.
Dexmethylphenidate (for conversion)
4,200,000
no change.
Dextropropoxyphene
35
no change.
Dihydrocodeine
132,658
no change.
Dihydroetorphine
25
no change.
Diphenoxylate (for conversion)
14,100
no change.
Diphenoxylate (for sale)
770,800
no change.
Ecgonine
60,492
no change.
Ethylmorphine
30
no change.
Etorphine hydrochloride
32
no change.
Fentanyl
731,452
no change.
Glutethimide
25
no change.
Hydrocodone (for conversion)
1,250
no change.
Hydrocodone (for sale)
27,239,822
no change.
Hydromorphone
1,994,125
no change.
Isomethadone
30
no change.
L-amphetamine
30
no change.
Levo-alphacetylmethadol (LAAM)
25
no change.
Levomethorphan
30
no change.
Levorphanol
23,010
no change.
Lisdexamfetamine
26,500,000
no change.
Meperidine
681,289
no change.
Meperidine Intermediate-A
30
no change.
Meperidine Intermediate-B
30
no change.
Meperidine Intermediate-C
30
no change.
Metazocine
15
no change.
Methadone (for sale)
25,619,700
no change.
Methadone Intermediate
27,673,600
no change.
Methamphetamine
150
no change.
d-methamphetamine (for conversion)
485,020
no change.
d-methamphetamine (for sale)
47,000
no change.
l-methamphetamine
587,229
no change.
Methylphenidate (for sale)
53,283,000
no change.
Methylphenidate (for conversion)
15,300,000
no change.
Metopon
25
no change.
Moramide-intermediate
25
no change.
Morphine (for conversion)
2,458,460
no change.
Morphine (for sale)
21,747,625
no change.
Nabilone
62,000
no change.
Norfentanyl
25
no change.
Noroxymorphone (for conversion)
22,044,741
no change.
Noroxymorphone (for sale)
1,000
no change.
Oliceridine
25,100
no change.
Opium (powder)
250,000
no change.
Opium (tincture)
530,837
no change.
Oripavine
33,010,750
no change.
Oxycodone (for conversion)
437,827
no change.
Oxycodone (for sale)
53,840,608
no change.
Oxymorphone (for conversion)
28,204,371
no change.
Oxymorphone (for sale)
516,351
no change.
Pentobarbital
33,843,337
no change.
Phenazocine
25
no change.
Phencyclidine
35
no change.
Phenmetrazine
25
no change.
Phenylacetone
100
no change.
Piminodine
25
no change.
Racemethorphan
5
no change.
Racemorphan
5
no change.
Remifentanil
3,000
no change.
Secobarbital
172,100
no change.
Sufentanil
4,000
no change.
Tapentadol
11,941,416
no change.
Thebaine
57,137,944
no change.
List I Chemicals
Ephedrine (for conversion)
41,100
no change.
Ephedrine (for sale)
4,136,000
no change.
Phenylpropanolamine (for conversion)
14,878,320
no change.
Phenylpropanolamine (for sale)
7,990,000
no change.
Pseudoephedrine (for conversion)
1,000
no change.
Pseudoephedrine (for sale)
174,246,000
no change.
The Administrator further proposes that APQ 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 Administrator may adjust the 2023 APQ and AAN as needed.
Conclusion
After consideration of any comments or objections, or after a hearing, if one is held, the Administrator will issue and publish in the
Federal Register
a final order establishing any adjustment of the 2023 APQ for each basic class of controlled substances in schedules I and II and AAN for the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine.
15
15
21 CFR 1303.13(c) and 1315.13(c).
Signing Authority
This document of the Drug Enforcement Administration was signed on October 25, 2023, by Administrator Anne Milgram. That document with the original signature and date is maintained by DEA. For administrative purposes only, and in compliance with requirements of the Office of the Federal Register, the undersigned DEA Federal Register Liaison Officer has been authorized to sign and submit the document in electronic format for publication, as an official document of DEA. This administrative process in no way alters the legal effect of this document upon publication in the
Federal Register
.
Scott Brinks,
Federal Register Liaison Officer, Drug Enforcement Administration.
[FR Doc. 2023-23931 Filed 10-30-23; 8:45 am]
BILLING CODE 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.