2023-23931. 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: [phone].

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]

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.

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]

DEA determined whether to propose an adjustment of the APQ for 2023 by considering the factors found at 21 CFR 1303.13(b): ^[4]

(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]

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]

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.

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.

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.

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]

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.

Footnotes

1.  28 CFR 0.100(b).

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).

3.  21 CFR 1303.13(a) and 1315.13(a).

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).

5.  74 FR 60294 (Nov. 20, 2009) and 75 FR 79407 (Dec. 20, 2010).

6.   Id.

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).

11.  87 FR 63091 (October 18, 2022).

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).

14.  Adjustment to the Aggregate Production Quota for Methylphenidate (for Sale) for 2023, 88 FR 68147 (October 3, 2023).

15.  21 CFR 1303.13(c) and 1315.13(c).