Schedules of Controlled Substances: Placement of Seven Specific Fentanyl-Related Substances in Schedule I

<RULE> DEPARTMENT OF JUSTICE <SUBAGY>Drug Enforcement Administration</SUBAGY> <CFR>21 CFR Part 1308</CFR> <DEPDOC>[Docket No. DEA-1457]</DEPDOC> <SUBJECT>Schedules of Controlled Substances: Placement of Seven Specific Fentanyl-Related Substances 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> The Drug Enforcement Administration places seven fentanyl-related substances, as identified in this final rule, including their isomers, esters, ethers, salts and salts of isomers, esters and ethers in schedule I of the Controlled Substances Act. The regulatory controls and administrative, civil, and criminal sanctions applicable to schedule I controlled substances on persons who handle (manufacture, distribute, import, export, engage in research, conduct instructional activities or chemical analysis, or possess), or propose to handle these seven specific controlled substances will continue to apply as a result of this action. </SUM> <EFFDATE> <HD SOURCE="HED">DATES:</HD> Effective September 18, 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> In this final rule, the Drug Enforcement Administration (DEA) permanently schedules the following seven controlled substances in schedule I of the Controlled Substances Act (CSA), including their isomers, esters, ethers, salts, and salts of isomers, esters, and ethers whenever the existence of such isomers, esters, ethers, and salts is possible within the specific chemical designation: • <E T="03">para</E> -chlorofentanyl ( <E T="03">N</E> -(4-chlorophenyl)- <E T="03">N</E> -(1-phenethylpiperidin-4-yl)propionamide), • <E T="03">ortho</E> -chlorofentanyl ( <E T="03">N</E> -(2-chlorophenyl)- <E T="03">N</E> -(1-phenethylpiperidin-4-yl)propionamide), • <E T="03">meta</E> -fluorofuranyl fentanyl ( <E T="03">N</E> -(3-fluorophenyl)- <E T="03">N</E> -(1-phenethylpiperidin-4-yl)furan-2-carboxamide), • <E T="03">ortho-</E> methylcyclopropyl fentanyl ( <E T="03">N</E> -(2-methylphenyl)- <E T="03">N</E> -(1-phenethylpiperidin-4-yl)cyclopropanecarboxamide), • <E T="03">beta-</E> methylacetyl fentanyl ( <E T="03">N</E> -phenyl- <E T="03">N</E> -(1-(2-phenylpropyl)piperidin-4-yl)acetamide), • tetrahydrothiofuranyl fentanyl ( <E T="03">N</E> -(1-phenethylpiperidin-4-yl)- <E T="03">N</E> -phenyltetrahydrothiophene-2-carboxamide), • <E T="03">para</E> -fluoro valeryl fentanyl ( <E T="03">N</E> -(4-fluorophenyl)- <E T="03">N</E> -(1-phenethylpiperidin-4-yl)pentanamide). <HD SOURCE="HD1">Legal Authority</HD> The CSA provides that proceedings for the issuance, amendment, or repeal of the scheduling of any drug or other substance may be initiated by the Attorney General (delegated to the Administrator of DEA pursuant to 28 CFR 0.100) on her own motion, at the request of the Secretary of Health and Human Services (HHS), or on the petition of an interested party. <SU>1</SU> <FTREF/> This action is supported by, <E T="03">inter alia,</E> a recommendation from the then-Assistant Secretary for Health of HHS (Assistant Secretary for HHS or Assistant Secretary) and an evaluation of all other relevant data by DEA. This action continues the imposition of the regulatory controls and administrative, civil, and criminal sanctions of schedule I controlled substances on any person who handles (manufactures, distributes, imports, exports, engages in research, or conducts instructional activities or chemical analysis with, or possesses) or proposes to handle these seven substances. <FTNT> <SU>1</SU>  21 U.S.C. 811(a). </FTNT> <HD SOURCE="HD1">Background</HD> On February 6, 2018, pursuant to 21 U.S.C. 811(h)(1), DEA published an order in the <E T="04">Federal Register</E> temporarily placing fentanyl-related substances, as defined in that order, in schedule I of the CSA based upon a finding that these substances pose an imminent hazard to the public safety. <SU>2</SU> <FTREF/> The seven substances named in this final rule meet the existing definition of fentanyl-related substances as they are not otherwise controlled in any other schedule ( <E T="03">i.e.,</E> not included under another DEA Controlled Substance Code Number) and are structurally related to fentanyl by one or more of the five modifications listed under the definition. That temporary order was effective upon the date of publication. <FTNT> <SU>2</SU>   <E T="03">Schedules of Controlled Substances: Temporary Placement of Fentanyl-Related Substances in Schedule I,</E> 83 FR 5188 (Feb. 6, 2018). </FTNT> Pursuant to 21 U.S.C. 811(h)(2), the temporary control of fentanyl-related substances, a class of substances as defined in the order, as well as the seven specific substances already covered by that order, was set to expire on February 6, 2020. However, on February 6, 2020, as explained in DEA's April 10, 2020, correcting amendment, <SU>3</SU> <FTREF/> Congress extended that expiration date until May 6, 2021, by enacting the Temporary Reauthorization and Study of the Emergency Scheduling of Fentanyl Analogues Act. <SU>4</SU> <FTREF/> This temporary order was subsequently extended multiple times, most recently on March 15, 2025, which extended the order until September 30, 2025. <SU>5</SU> <FTREF/> Also, on December 30, 2024, the then-DEA Administrator extended the temporary order in a separate action. <SU>6</SU> <FTREF/> On the same day, the then-Administrator, on her own motion pursuant to 21 U.S.C. 811(a), initiated scheduling proceedings and published a notice of proposed rulemaking (NPRM) to permanently control these seven specific fentanyl-related substances in schedule I of the CSA. <SU>7</SU> <FTREF/> Specifically, DEA proposed to add these substances to the opiates list under 21 CFR 1308.11(b). <FTNT> <SU>3</SU>   <E T="03">Schedules of Controlled Substances: Temporary Placement of Fentanyl-Related Substances in Schedule I; Correction,</E> 85 FR 20155 (Apr. 10, 2020). </FTNT> <FTNT> <SU>4</SU>  Public Law 116-114, sec. 2, 134 Stat. 103. </FTNT> <FTNT> <SU>5</SU>  Public Law 119-4, sec. 3105, 139 Stat. 9. </FTNT> <FTNT> <SU>6</SU>   <E T="03">See</E> Schedules of Controlled Substances: Extension of Temporary Placement of Seven Specific Fentanyl-Related Substances in Schedule I of the Controlled Substances Act, 89 FR 106311 (Dec. 30, 2024). </FTNT> <FTNT> <SU>7</SU>   <E T="03">See</E> Schedules of Controlled Substances: Placement of Seven Specific Fentanyl-Related Substances in Schedule I, 89 FR 106384 (Dec. 30, 2024). After the publication of the NPRM, Congress enacted the HALT Fentanyl Act, Public Law 119-26 (July 16, 2025), which, among other things, permanently places fentanyl-related substances as a class into schedule I of the CSA. </FTNT> <HD SOURCE="HD1">DEA and HHS Eight Factor Analyses</HD> On October 25, 2024, the then-Assistant Secretary submitted HHS's scientific and medical evaluation and scheduling recommendation for <E T="03">para</E> -chlorofentanyl, <E T="03">ortho</E> -chlorofentanyl, <E T="03">meta</E> -fluorofuranyl fentanyl, <E T="03">ortho-</E> methylcyclopropyl fentanyl, <E T="03">beta-</E> methylacetyl fentanyl, tetrahydrothiofuranyl fentanyl, and <E T="03">para</E> -fluoro valeryl fentanyl and their salts to the then-Administrator, which recommended placing these seven specific fentanyl-related substances and their salts in schedule I of the CSA. In accordance with 21 U.S.C. 811(c), upon receipt of the scientific and medical evaluation and scheduling recommendation from HHS, DEA reviewed the documents and all other relevant data and conducted its own eight-factor analysis of the abuse potential of these seven fentanyl-related substances. <SU>8</SU> <FTREF/> <FTNT> <SU>8</SU>  Both the 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-1457.” </FTNT> <HD SOURCE="HD1">Determination To Permanently Schedule Seven Specific Fentanyl-Related Substances</HD> After review of the available data, including the scientific and medical evaluation and the scheduling recommendations from HHS, DEA published an NPRM in the <E T="04">Federal Register</E> on December 30, 2024, which proposed the placement of seven specific fentanyl-related substances in schedule I of the CSA. <SU>9</SU> <FTREF/> The NPRM provided an opportunity for interested persons to file a request for a hearing in accordance with DEA regulations on or before January 29, 2025. DEA did not receive a hearing request. The NPRM also provided an opportunity for interested persons to submit comments on the proposed rule on or before January 29, 2025. DEA did not receive any comment on the proposed rule to control these seven specific fentanyl-related substances in schedule I of the CSA. <FTNT> <SU>9</SU>   <E T="03">See</E> Schedules of Controlled Substances: Placement of Seven Specific Fentanyl-Related Substances in Schedule I, 89 FR 106384 (Dec. 30, 2024). </FTNT> <HD SOURCE="HD1">Scheduling Conclusion</HD> After consideration of the scientific and medical evaluation and accompanying scheduling recommendation of HHS, and DEA's own eight-factor analysis, DEA finds that these facts and all relevant data constitute substantial evidence of potential for abuse for <E T="03">para</E> -chlorofentanyl, <E T="03">ortho</E> -chlorofentanyl, <E T ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 37k characters. 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