Health Law Daily Wrap Up, DRUGS AND BIOLOGICS—FINAL RULES: DEA places newly approved anesthetic Cipepofol in Schedlue IV, (Aug 31, 2026)

By WK Editorial Staff

FDA-approved anesthetic cipepofol will now be subject to Schedule IV controls, reflecting DEA’s determination that its abuse and dependence risks are similar to those of propofol.

The DEA issued an interim final rule placing cipepofol, an intravenous anesthetic recently approved by the FDA for the induction of general anesthesia in adults undergoing surgery, into Schedule IV of the Controlled Substances Act. The agency determined that cipepofol has a low potential for abuse relative to Schedule III substances, citing preclinical and human studies showing abuse liability and dependence risks comparable to propofol, a similar anesthetic. DEA noted that although there is no evidence of abuse, misuse, or diversion in the United States, cipepofol's pharmacological profile and reinforcing effects support Schedule IV control. The rule took effect August 27, 2026, and subjects the drug to the registration, recordkeeping, security, and other regulatory requirements applicable to Schedule IV controlled substances (Final Rule, 91 Fed. Reg. 55259 (Aug. 27, 2026)).

Dates. This rule is effective August 27, 2026. Comments must be submitted electronically or postmarked on or before September 28, 2026. 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. Requests for hearing and waivers of an opportunity for a hearing or to participate in a hearing, together with a written statement of position on the matters of fact and law asserted in the hearing, must be received on or before September 28, 2026.

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