1117-AB75 202304 Unified Agenda of Federal Regulatory and Deregulatory Actions 1117 Drug Enforcement Administration DEA 1100 Department of Justice DOJ Schedules of Controlled Substances; Exempted Prescription Products

The Drug Enforcement Administration (DEA) proposes to revoke the exempted prescription product status for all butalbital products previously granted exemptions. DEA has observed a pattern of diversion, online distribution, and abuse of exempted butalbital products. In particular, DEA has observed exploitation of the exempted prescription product status of butalbital combination products to enable abuse. Therefore, DEA has concluded that these products do not meet the exemption criteria found in 21 U.S.C. 811(g)(3)(A).

]]> Other Significant Previously Published in The Unified Agenda Final Rule Stage No No 21 CFR 1308.31 21 CFR 1308.32 21 U.S.C. 811(g)(3) No NPRM 04/12/2022 87 FR 21588 NPRM Comment Period End 05/12/2022 Final Action 07/00/2023 DEA Docket number 384 No Businesses None No No DPW@dea.gov www.regulations.gov No No Scott Brinks A. Section Chief, Regulatory Drafting and Support Section, Diversion Control Division 1117 Drug Enforcement Administration DEA 571 362-8209 scott.a.brinks@dea.gov 8701 Morrissette Drive, Springfield VA 22152