Notices. Notice with request for comments

4,873 words·~22 min read·/register/2024/09/25/2024-21960·

A research copy — for the controlling text, always check the official state or federal source. Not legal advice.

BILLING CODE 8011-01-P 89 186 Wednesday, September 25, 2024 Notices Part VIII Department of Justice Drug Enforcement Administration 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; Notices 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 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). 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 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 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 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). 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

(PDMP)data from the states. DEA considered this information in developing the estimates of diversion for the five covered controlled substances for this proposed adjustment. 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. 10 88 FR 75312 (November 2, 2023). Diversion Estimates for 2024 ( g ) 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. 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. 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: 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-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-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 (α-PBP) 25 no change alpha-pyrrolidinoheptaphenone

(PV8)25 no change alpha-pyrrolidinohexabophenone (alpha-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 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 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]

Connectionstraces to 5

Traces to 5 documents

CFR

U.S. Code