Federal Register #2026-23075

DEA rule placing oveporexton in Schedule IV

The DEA issued a regulatory rule placing oveporexton under Schedule IV controls; this is not a procurement opportunity. - Government buyer/issuing agency: U.S. Department of Justice, Drug Enforcement Administration (DEA). - The action follows an FDA approval and a scheduling recommendation from the U.S. Department of Health and Human Services (HHS). - Drug and brand: Oveporexton, including its salts and isomers; the brand name Orzeyful is mentioned for treatment of adults with narcolepsy type 1. - OEMs/vendors: No manufacturer, OEM, reseller, or vendor is identified in the notice. - Requirements: Schedule IV controls apply, including registration, security, inventory, recordkeeping, labeling, prescription, and handling requirements. The DEA requests public comments. - Procurement scope: No products or services are being solicited; no quantities, part numbers, or contract value are provided.

Description

The Drug Enforcement Administration is placing oveporexton, including its salts, isomers, and salts of isomers, in Schedule IV of the Controlled Substances Act. This follows FDA approval of Orzeyful (oveporexton) for treating narcolepsy type 1 in adults and a scheduling recommendation from the Department of Health and Human Services. The interim final rule is effective November 12, 2026, and requests comments by December 14, 2026.

View original listing