Federal Register #DEA 1713

DEA Schedules Cipepofol (Cypsedo) as a Schedule IV Controlled Substance

This notice announces a regulatory action by the Drug Enforcement Administration (DEA), part of the Department of Justice, regarding the scheduling of cipepofol: - Government Buyer: - Department of Justice (DOJ) - Drug Enforcement Administration (DEA) - OEM/Vendor Mentioned: - Cypsedo (cipepofol) - Chemical name: 2-[(1R)-1-cyclopropylethyl]-6-isopropylphenol - Products/Services Requested: - No specific products or purchase quantities are requested - The notice pertains to the regulatory classification of cipepofol, not a procurement action - Unique or Notable Requirements: - Cipepofol is placed in Schedule IV of the Controlled Substances Act (CSA) - Entities handling cipepofol must comply with DEA registration, security, labeling, inventory, recordkeeping, and prescription standards - Applies to manufacturers, distributors, importers, exporters, and prescribers of cipepofol - No contract value, product line items, or service line items are specified, as this is a regulatory notice, not a procurement opportunity.

Description

The Drug Enforcement Administration (DEA) is issuing an interim final rule to place cipepofol, a drug approved by the FDA for induction of general anesthesia in adults, into Schedule IV of the Controlled Substances Act (CSA). This action follows a recommendation from the Department of Health and Human Services and is in accordance with the CSA and the Improving Regulatory Transparency for New Medical Therapies Act. The rule outlines regulatory controls, registration requirements, security, labeling, inventory, recordkeeping, and prescription standards for handling cipepofol. Comments on the rule are requested by September 28, 2026.

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