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HHS/FDA RIN: 0910-AH61 Publication ID: Spring 2025 
Title: Current Good Manufacturing Practice for Outsourcing Facilities 
Abstract:

This rule would set forth the minimum current good manufacturing practice (CGMP) requirements for human drug products compounded by an outsourcing facility.

 
Agency: Department of Health and Human Services(HHS)  Priority: Substantive, Nonsignificant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: No  Unfunded Mandates: No 
EO 14192 Designation: Regulatory 
CFR Citation: 21 CFR 214   
Legal Authority: 21 U.S.C. 351    21 U.S.C. 352    21 U.S.C. 353b    21 U.S.C. 371   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  05/00/2026 
Regulatory Flexibility Analysis Required: Undetermined  Government Levels Affected: None 
Small Entities Affected: Businesses  Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
Agency Contact:
Ashley Boam
Health Science Administrator
Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research, Building 51, Room 4192, 10903 New Hampshire Avenue,
Silver Spring, MD 20993
Phone:301 796-6341
Email: ashley.boam@fda.hhs.gov