Schedules of Controlled Substances: Placement of 4-Chloromethcathinone in Schedule I

<RULE> DEPARTMENT OF JUSTICE <SUBAGY>Drug Enforcement Administration</SUBAGY> <CFR>21 CFR Part 1308</CFR> <DEPDOC>[Docket No. DEA-1246]</DEPDOC> <SUBJECT>Schedules of Controlled Substances: Placement of 4-Chloromethcathinone in Schedule I</SUBJECT> <HD SOURCE="HED">AGENCY:</HD> Drug Enforcement Administration, Department of Justice. <HD SOURCE="HED">ACTION:</HD> Final rule. <SUM> <HD SOURCE="HED">SUMMARY:</HD> With the issuance of this final rule, the Drug Enforcement Administration places 4-chloromethcathinone (4-CMC, 1-(4-chlorophenyl)-2-(methylamino)propan-1-one), including its salts, isomers, and salts of isomers, in schedule I of the Controlled Substances Act. This action is being taken, in part, to enable the United States to meet its obligations under the 1971 Convention on Psychotropic Substances. This action imposes the regulatory controls and administrative, civil, and criminal sanctions applicable to schedule I controlled substances on persons who handle (manufacture, distribute, reverse distribute, import export, engage in research, conduct instructional activities or chemical analysis with, or possess) or propose to handle 4-chloromethcathinone. </SUM> <EFFDATE> <HD SOURCE="HED">DATES:</HD> <E T="03">Effective date:</E> December 17, 2025. </EFFDATE> <FURINF> <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD> Dr. Terrence L. Boos, Drug and Chemical Evaluation Section, Diversion Control Division, Drug Enforcement Administration; Telephone: (571) 362-3249. </FURINF> <SUPLINF> <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD> <HD SOURCE="HD1">Legal Authority</HD> The United States is a party to the 1971 United Nations Convention on Psychotropic Substances (1971 Convention), Feb. 21, 1971, 32 U.S.T. 543, 1019 U.N.T.S. 175, as amended. Procedures respecting changes in drug schedules under the 1971 Convention are governed domestically by 21 U.S.C. 811(d)(2)-(4). When the United States receives notification of a scheduling decision pursuant to Article 2 of the 1971 Convention indicating that a drug or other substance has been added to a schedule specified in the notification, the Secretary of Health and Human Services (Secretary), <SU>1</SU> <FTREF/> after consultation with the Attorney General, shall first determine whether existing legal controls under subchapter I of the Controlled Substances Act (CSA) and the Federal Food, Drug, and Cosmetic Act meet the requirements of the schedule specified in the notification with respect to the specific drug or substance. <SU>2</SU> <FTREF/> In the event that the Secretary did not so consult with the Attorney General, and the Attorney General did not issue a temporary order, as provided under 21 U.S.C. 811(d)(4), the procedures for permanent scheduling set forth in 21 U.S.C. 811(a) and (b) control. <FTNT> <SU>1</SU>  As discussed in a memorandum of understanding entered into by the FDA and the National Institute on Drug Abuse (NIDA), FDA acts as the lead agency within HHS in carrying out the Secretary's scheduling responsibilities under the CSA, with the concurrence of NIDA. 50 FR 9518 (Mar. 8, 1985). The Secretary has delegated to the Assistant Secretary for Health of HHS the authority to make domestic drug scheduling recommendations. 58 FR 35460 (July 1, 1993). </FTNT> <FTNT> <SU>2</SU>  21 U.S.C. 811(d)(3). </FTNT> Pursuant to 21 U.S.C. 811(a)(1) and (2), the Attorney General (as delegated to the Administrator of the Drug Enforcement Administration (DEA) pursuant to 28 CFR 0.100) may, by rule, and upon the recommendation of the Secretary, add to such a schedule or transfer between such schedules any drug or other substance, if he finds that such drug or other substance has a potential for abuse, and makes with respect to such drug or other substance the findings prescribed by 21 U.S.C. 812(b) for the schedule in which such drug or other substance is to be placed. <HD SOURCE="HD1">Background</HD> 4-Chloromethcathinone (4-CMC) is a central nervous system stimulant that shares structural and pharmacological similarities with schedule I synthetic cathinones such as 4-methylethcathinone (4-MEC), 4-fluoromethcathinone (4-FMC), and 3-fluoromethcathinone (3-FMC), and schedule II stimulants such as amphetamine and methamphetamine. On May 7, 2020, the Secretary-General of the United Nations advised the Secretary of State of the United States that the Commission on Narcotic Drugs (CND) voted to place 4-CMC in Schedule II of the 1971 Convention during its 63rd session held in March 2020 (CND Dec/63/9). As a signatory to the 1971 Convention, the United States is required, by scheduling under the CSA, to place appropriate controls on 4-CMC to meet the minimum requirements of the treaty. Because the procedures in 21 U.S.C. 811(d)(3) and (4) for consultation and issuance of a temporary order for 4-CMC, discussed in the above legal authority section, were not followed, DEA is utilizing the procedures for permanent scheduling set forth in 21 U.S.C. 811(a) and (b) to control 4-CMC. Such scheduling would satisfy the United States' international obligations. <HD SOURCE="HD1">DEA and HHS Eight Factor Analyses</HD> In a letter dated December 22, 2022, in accordance with 21 U.S.C. 811(b), and in response to DEA's May 12, 2021, request, Department of Health and Human Services (HHS) provided to DEA a scientific and medical evaluation and scheduling recommendation for 4-CMC. DEA reviewed the scientific and medical evaluation and scheduling recommendation for schedule I placement provided by HHS, and all other relevant data, pursuant to 21 U.S.C. 811(b) and (c), and conducted its own analysis under the eight factors stipulated in 21 U.S.C. 811(c). DEA found, under 21 U.S.C. 811(b)(1), that this substance warrants control in schedule I. Both DEA and HHS Eight-Factor analyses are available in their entirety under the tab Supporting Documents of the public docket for this action at <E T="03">https://www.regulations.gov</E> under docket number DEA-1246. <HD SOURCE="HD1">Notice of Proposed Rulemaking to Schedule 4-CMC </HD> On December 30, 2024, DEA published a notice of proposed rulemaking (NPRM) to permanently control 4-CMC in schedule I. <SU>3</SU> <FTREF/> Specifically, DEA proposed to add 4-CMC to the list of hallucinogenic substances under 21 CFR 1308.11(d). The NPRM provided an opportunity for interested persons to file a request for hearing in accordance with DEA regulations on or before January 29, 2025. DEA did not receive any requests for such a hearing. The NPRM also provided an opportunity for interested persons to submit comments on or before January 29, 2025. <FTNT> <SU>3</SU>  Schedules of Controlled Substances: Placement of 4-Chloromethcathinone in Schedule I, 89 FR 106376 (Dec. 30, 2024). </FTNT> <HD SOURCE="HD1">Comments Received</HD> DEA received one comment in response to the NPRM for the placement of 4-CMC into schedule I of the CSA. The submission was from an anonymous commenter against the placement of 4-CMC in schedule I of the CSA in part due to potential medical use of this substance that has yet to be investigated since it is a new substance. This commenter opined that adding 4-CMC to schedule I would make it difficult to do future research for potential medical use. The commenter also made a comparison of the fewer number of law enforcement encounters to fentanyl and noted that other substances that are not controlled under the CSA have a higher prevalence of recreational use. <E T="03">DEA Response:</E> DEA appreciates this comment and would like to provide further clarification regarding the control of 4-CMC. 4-CMC has been placed under international control. In order to comply with treaty obligations, DEA must place 4-CMC under the most appropriate schedule, taking into consideration all appropriate scientific data. Additionally, as set forth in the NPRM, 4-CMC has no currently accepted medical use in treatment in the United States, nor were there any New Drug Applications. Therefore, 4-CMC must be placed in schedule I of the CSA along with other substances which have no currently accepted medical use, lack accepted safety for use under medical supervision, and possess a high potential for abuse. With respect to research for potential medical use, the placement of substances in schedule I of the CSA does not preclude academic research on these substances. <SU>4</SU> <FTREF/> DEA registrants wishing to conduct research on schedule I substances may apply for permission to do so through the schedule I researcher registration program. <SU>5</SU> <FTREF/> <FTNT> <SU>4</SU>  21 U.S.C. 823(g)(2)(A). </FTNT> <FTNT> <SU>5</SU>   <E T="03">https://apps.deadiversion.usdoj.gov/webforms2/spring/login?execution=e1s1.</E> </FTNT> <HD SOURCE="HD1">Scheduling Conclusion</HD> After consideration of the public comment, scientific and medical evaluation and accompanying scheduling recommendation from HHS, and after its own eight-factor evaluation, DEA finds that these facts and all relevant data constitute substantial evidence of potential for abuse of 4-CMC. As such, DEA is permanently scheduling 4-CMC as a controlled substance under schedule I of the CSA. The permanent scheduling of 4-CMC fulfills the United States' obligations as a party to the 1971 Convention. <HD SOURCE="HD1">Determination of Appropriate Schedule</HD> The CSA establishes five schedules of controlled substances known as schedules I, II, II, IV, and V. The CSA also specifies the findings requires to place a drug or other substance in any particular schedule, 21 U.S.C. 812(b). After consideration of the analysis and recommendation of the then Assistant Secretary for Health of HHS and review of all other available data, the Administrator of DEA, pursuant to 21 U.S.C. 812(b)(1), finds that: (1) 4-CMC has a high potential for abuse that is comparable to other sche ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 26k characters. Full document text is stored and available for version comparison. ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━