89 FR 186 pgs. 78764-78772 - 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 2024
Type: NOTICEVolume: 89Number: 186Pages: 78764 - 78772
Pages: 78764, 78765, 78766, 78767Docket number: [Docket No. DEA-1228A]
FR document: [FR Doc. 2024-21960 Filed 9-20-24; 4:15 pm]
Agency: Justice Department
Sub Agency: Drug Enforcement Administration
Official PDF Version: PDF Version
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-1228A]
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 2024
AGENCY:
Drug Enforcement Administration, Department of Justice.
ACTION:
Notice with request for comments.
SUMMARY:
The Drug Enforcement Administration proposes to adjust the 2024 aggregate production quotas for several controlled substances in schedules I and II of the Controlled Substances Act. Additionally, as DEA announced in an April 29, 2024 letter to DEA-registered manufacturers, procurement quotas for commercial manufacturing of a schedule II controlled substance will be calculated on a semi-annual basis, except for injectable drug products containing schedule II controlled substances, which will be calculated on an annual basis.
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 October 25, 2024. 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 2024 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-1228A" 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:
Heather E. Achbach, 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. 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 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 (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 pursuant to 28 CFR 0.100.
DEA established the 2024 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 January 3, 2024. 1 That order stipulated that, in accordance with 21 CFR 1303.13 and 1315.13, all APQ and AAN are subject to adjustment. DEA published a Final Order revising the 2024 lisdexamfetamine and d-amphetamine (for conversion) APQ on September 5, 2024. 2
Footnotes:
1 ?89 FR 407.
2 ?Adjustment to the Aggregate Production Quota for Lisdexamfetamine and d-Amphetamine (for Conversion) for 2024, 89 FR 72424 (Sept. 5, 2024).
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Analysis for Proposed Adjusted 2024 Aggregate Production Quotas and Assessment of Annual Needs
DEA proposes to adjust the established 2024 APQ for certain schedule I and II controlled substances and the AAN for certain list I chemicals to be manufactured in the United States in 2024 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.
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
Footnotes:
3 ?21 CFR 1303.13(a), 1315.13(a).
DEA determined whether to propose an adjustment of the APQ for 2024 by considering the factors found at 21 CFR 1303.13(b):
(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 [21 CFR] 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 [21 CFR] 1303.24(b) or abandoned pursuant to [21 CFR] 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 2023 year-end inventories, 2023 disposition data submitted by quota applicants, changes in estimates of the medical needs of the United States, 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 2024 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 [21 CFR] 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 [21 CFR] 1315.24(b) or abandoned pursuant to [21 CFR] 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 2024 AAN for list I chemicals, DEA used the calculation methodology previously described in the 2010 and 2011 AAN. 4 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. 5
Footnotes:
4 ?74 FR 60294 (Nov. 20, 2009); 75 FR 79407 (Dec. 20, 2010).
5 ?74 FR 60294 (Nov. 20, 2009); 75 FR 79407 (Dec. 20, 2010).
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."? 6 The covered controlled substances are fentanyl, oxycodone, hydrocodone, oxymorphone, and hydromorphone. 7 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."? 8 When estimating diversion, the Administrator "shall consider information" that she, in consultation with the Secretary of Health and Human Services, "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 she determines reliable. 9
Footnotes:
6 ?21 U.S.C. 826(i)(1)(A).
7 ?21 U.S.C. 826(i)(1).
8 ?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).
9 ?21 U.S.C. 826(i)(1)(B).
[top] DEA sent letters to the Centers for Disease Control and Prevention (CDC), the Food and Drug Administration (FDA), and the states in March, April, and May 2024 requesting overdose death and overprescribing data that could be considered in estimating diversion. DEA received information from the CDC in May 2024, the FDA in June 2024, and has begun receiving Prescription Data Monitoring Program
DEA also aggregated data for each covered controlled substance from Drug Theft and Loss Reports to determine the estimates of diversion. 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 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 2024. 10 Below, DEA provides an updated chart showing estimations of diversion for each of the covered controlled substances.
Footnotes:
10 ?88 FR 75312 (November 2, 2023).
| Fentanyl | 112 |
| Hydrocodone | 124,170 |
| Hydromorphone | 1,137 |
| Oxycodone | 263,236 |
| Oxymorphone | 165 |
Implementation of Semi-Annual Quota Allotment
For the 2024 quota year, DEA announced that it intended to allocate procurement quotas to DEA-registered manufacturers of schedule II controlled substances on a quarterly basis, in order to help DEA prevent shortages and be more nimble in its administration of the quota program. After the announcement, DEA met with several manufacturers to discuss the impact of that change. Numerous manufacturers asked DEA to consider allocating quotas semi-annually to assist with production planning and execution. DEA understands and appreciates the complexities of the supply chain. In light of the discussions with manufacturers, as well as meetings with FDA discussing their statutory obligations for drug availability to meet legitimate patients' needs, input from health associations in foreign countries, and consideration of the continuing issues with the supply chain in the aftermath of the COVID-19 pandemic, DEA determined that it would and will allocate procurement quotas for schedule II controlled substances on a semi-annual basis, except that it would and will allocate procurement quotas for injectable drug products containing schedule II controlled substances on an annual basis. DEA announced this change in a letter to DEA-registered manufacturers on April 29, 2024. No further change is being implemented at this time. DEA remains committed to ensuring that all patients with legitimate medical need can access appropriately prescribed medications that are manufactured domestically.
Proposed Adjustments for the 2024 Aggregate Production Quotas and Assessment of Annual Needs
DEA is proposing increases to the APQ for the following schedule I substances: 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. The proposed increases reflect research and development needs as part of the process for seeking the FDA approval of new drug products.
DEA is proposing increases to the APQ for the following schedule II substances: noroxymorphone (for conversion), oripavine, and oxymorphone (for conversion). These proposed increases are necessary to meet manufacturing needs and increased consumption of naloxone products as standard treatment for opioid overdose. These substances are part of the synthesis pathway to manufacture naloxone products. On March 13, 2024, the "White House Challenge to Save Lives from Overdose" was announced in support of the Administration's Unity Agenda efforts to address the opioid overdose crisis. 11 The challenge is a nationwide initiative to increase training, awareness, and access to lifesaving opioid overdose reversal medications. The FDA has approved two over the counter (OTC) naloxone products for the emergency treatment of opioid overdose. 12 As a result of the White House Challenge and efforts by the Department of Health and Human Services to help recipients of State and Tribal Opioid Response Grants increase distribution of opioid overdose reversal agents, DEA is expecting medical usage of naloxone to continue to rise in 2024. The proposed increase to the APQ of noroxymorphone (for conversion), oripavine and oxymorphone (for conversion) reflects this increasing medical usage of naloxone.
Footnotes:
11 ? https://www.whitehouse.gov/briefing-room/statements-releases/2024/03/13/fact-sheet-biden-harris-administration-launches-the-white-house-challenge-to-save-lives-from-overdose/.
12 ? https://www.fda.gov/news-events/press-announcements/fda-approves-second-over-counter-naloxone-nasal-spray-product .
DEA is proposing decreases to the following APQ: fentanyl, hydrocodone (for sale), hydromorphone, and oxycodone (for sale). These proposed decreases are based on adjustments to the diversion estimates for calendar year 2024.
DEA established the 2024 APQ for substances in schedules I and II on January 3, 2024. 13 Subsequent to that publication, DEA published in the Federal Register a final rule to permanently schedule 2-methyl AP-237 under the CSA. 14 As a result, this substance is subject to CSA schedule I controls and DEA is proposing to assign an individual APQ for this substance pursuant to 21 U.S.C. 826 and 21 CFR part 1303.
Footnotes:
13 ?89 FR 407.
14 ?89 FR 18793 (March, 15, 2024).
The Administrator, therefore, proposes to adjust the 2024 APQ for the schedule I and II controlled substances noroxymorphone (for conversion), oripavine, oxymorphone (for conversion), psilocybin, psilocyn, and 2-methyl AP-237. The proposed adjusted APQ and AAN, as expressed in grams of anhydrous acid or base, are as follows:
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| Basic class | Established 2024 quotas (g) | Proposed revised 2024 quotas (g) |
|---|---|---|
| New Temporary Controlled Schedule I Substances | ||
| 4F-MDMB-BUTICA | 30 | no change |
| 5F-EDMB-PICA | 30 | no change |
| ADB-4en-PINACA | 30 | no change |
| Clonazolam | 30 | no change |
| CUMYL-PEGACLONE | 30 | no change |
| Diclazepam | 30 | no change |
| Etizolam | 30 | no change |
| Flualprazolam | 30 | no change |
| Flubromazolam | 30 | no change |
| MDMB-4en-PINACA | 30 | no change |
| MMB-FUBICA | 30 | no change |
| Schedule I | ||
| -[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 |
| 2-Methyl AP-237 | 0 | 30 |
| 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-Methylmethcathinone | 30 | no change |
| 3-Methylthiofentanyl | 30 | no change |
| 4,4'-Dimethylaminorex | 30 | no change |
| 4-Bromo-2,5-dimethoxyamphetamine (DOB) | 30 | no change |
| 4-Bromo-2,5-dimethoxyphenethylamine (2-CB) | 5,100 | no change |
| 4-Chloro-alpha-pyrrolidinovalerophenone (4-chloro-alpha-PVP) | 25 | no change |
| 4-CN-Cumyl-Butinaca | 25 | 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-1-phenyl-2-(pyrrolidin-1-yl)pentan-1-one (alpha-PiHP) | 30 | 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-a-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-BUTINACA | 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 | 1,166,130 | no change |
| 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 (a-PBP) | 25 | no change |
| alpha-pyrrolidinoheptaphenone (PV8) | 25 | no change |
| alpha-pyrrolidinohexabophenone (alpha-PHP) | 25 | no change |
| alpha-Pyrrolidinopentiophenone (a-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 | 1,523,040 | no change |
| 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 | 639,954 | no change |
| Dimenoxadol | 25 | no change |
| Dimepheptanol | 25 | no change |
| Dimethylthiambutene | 20 | no change |
| Dimethyltryptamine | 11,000 | no change |
| Dioxyaphetyl butyrate | 25 | no change |
| Dipipanone | 25 | no change |
| Drotebanol | 25 | no change |
| Ethylmethylthiambutene | 25 | no change |
| Ethylone | 25 | no change |
| Etodesnitazene | 30 | no change |
| Etonitazene | 25 | no change |
| Etorphine | 30 | no change |
| Etoxeridine | 25 | no change |
| Eutylone | 30 | no change |
| Fenethylline | 30 | no change |
| Fentanyl carbamate | 30 | no change |
| Fentanyl related substances | 600 | no change |
| Flunitazene | 30 | no change |
| FUB-144 | 25 | 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 | 150 | no change |
| 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 | 30 | no change |
| Methaqualone | 60 | no change |
| Methcathinone | 25 | no change |
| Methiopropamine | 30 | no change |
| 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 |
| N-Pyrrolidino Etonitazene | 30 | no change |
| Noracymethadol | 25 | 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 | 20,000 | 30,000 |
| Psilocyn | 24,000 | 36,000 |
| 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 | 30 | no change |
| 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 |
| Bezitramide | 25 | no change |
| Carfentanil | 20 | no change |
| Cocaine | 60,492 | no change |
| Codeine (for conversion) | 942,452 | no change |
| Codeine (for sale) | 19,262,957 | no change |
| d-amphetamine (for sale) | 21,200,000 | no change |
| d,l-amphetamine | 21,200,000 | no change |
| d-amphetamine (for conversion) | 23,688,235 | no change |
| Dexmethylphenidate (for sale) | 6,200,000 | no change |
| Dexmethylphenidate (for conversion) | 5,374,683 | no change |
| Dextropropoxyphene | 35 | no change |
| Dihydrocodeine | 115,227 | 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 | 731,360 | 731,341 |
| Glutethimide | 25 | no change |
| Hydrocodone (for conversion) | 1,250 | no change |
| Hydrocodone (for sale) | 27,143,545 | 27,121,498 |
| Hydromorphone | 1,951,801 | 1,951,508 |
| Isomethadone | 30 | no change |
| L-amphetamine | 30 | no change |
| Levo-alphacetylmethadol (LAAM) | 25 | no change |
| Levomethorphan | 30 | no change |
| Levorphanol | 20,000 | no change |
| Lisdexamfetamine | 32,736,000 | no change |
| Meperidine | 681,184 | 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 |
| d,l-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) | 19,975,468 | no change |
| Metopon | 25 | no change |
| Moramide-intermediate | 25 | no change |
| Morphine (for conversion) | 2,393,200 | no change |
| Morphine (for sale) | 20,805,957 | no change |
| Nabilone | 62,000 | no change |
| Norfentanyl | 25 | no change |
| Noroxymorphone (for conversion) | 22,044,741 | 24,756,979 |
| 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 | 37,721,950 |
| Oxycodone (for conversion) | 437,827 | no change |
| Oxycodone (for sale) | 53,658,226 | 53,584,449 |
| Oxymorphone (for conversion) | 28,204,371 | 31,773,105 |
| Oxymorphone (for sale) | 464,464 | no change |
| Pentobarbital | 40,000,000 | 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 | 10,390,226 | no change |
| Thebaine | 57,137,944 | no change |
| List I Chemicals | ||
| Ephedrine (for conversion) | 41,100 | no change |
| Ephedrine (for sale) | 3,933,336 | 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) | 186,617,466 | no change |
The Administrator further proposes that the 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 2024 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 2024 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
Footnotes:
15 ?21 CFR 1303.13(c) and 1315.13(c).
Signing Authority
This document of the Drug Enforcement Administration was signed on September 20, 2024, 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 .
Heather Achbach,
Federal Register Liaison Officer, Drug Enforcement Administration.
[FR Doc. 2024-21960 Filed 9-20-24; 4:15 pm]
BILLING CODE P