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DOJ/DEA RIN: 1117-AB75 Publication ID: Fall 2023 
Title: 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).

Agency: Department of Justice(DOJ)  Priority: Other Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Final Rule Stage 
Major: No  Unfunded Mandates: No 
CFR Citation: 21 CFR 1308.31    21 CFR 1308.32   
Legal Authority: 21 U.S.C. 811(g)(3)   
Legal Deadline:  None
Action Date FR Cite
NPRM  04/12/2022  87 FR 21588   
NPRM Comment Period End  05/12/2022 
Final Action  11/00/2023 
Additional Information: DEA Docket number 384
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Small Entities Affected: Businesses  Federalism: No 
Included in the Regulatory Plan: No 
RIN Information URL:   Public Comment URL:  
RIN Data Printed in the FR: No 
Agency Contact:
Scott A. Brinks
Section Chief, Regulatory Drafting and Support Section, Diversion Control Division
Department of Justice
Drug Enforcement Administration
8701 Morrissette Drive,
Springfield, VA 22152
Phone:571 362-8209