Federal Register #FDA-2026-N-9208

FDA Request for Comments on International Drug Scheduling for Eight Substances

The Food and Drug Administration (FDA), part of the Department of Health and Human Services, is requesting public comments to inform international drug scheduling decisions for eight substances. - Government Buyer: - Department of Health and Human Services - Food and Drug Administration (FDA) - OEMs and Vendors: - FDA (regulatory agency) - United Nations Expert Committee on Drug Dependence (ECDD) - Substances Under Review: - Clobromazolam (Phenazolam) - Cychlorphine (N-Propionitrile Chlorphine) - Desalkylgidazepam (Bromonordiazepam) - Ethylbromazolam - Etomethazene (5-Methyl Etodesnitazene) - Spirochlorphine (R6980) - Etomidate - Medetomidine - Requested Information: - Abuse potential and actual abuse - Medical usefulness - Trafficking and diversion - Impact of potential scheduling changes - Unique Requirements: - Detailed scientific, medical, and public health information - Input will inform the U.S. response to the ECDD's review - No products or services are being procured; this is a request for information to support regulatory decision-making.

Description

The Food and Drug Administration (FDA) is requesting comments on the abuse potential, actual abuse, medical usefulness, trafficking, and impact of scheduling changes on availability for medical use of eight drug substances. These comments will inform the United States' response to the Expert Committee on Drug Dependence (ECDD) regarding the abuse liability and diversion of these drugs. The ECDD will consider this information to recommend whether international restrictions should be placed on these substances. The notice is required by the Controlled Substances Act (CSA) and comments are due by September 3, 2026.

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