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HHS/FDA RIN: 0910-AH61 Publication ID: Fall 2017 
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: Economically Significant 
RIN Status: First time published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: Undetermined  Unfunded Mandates: Undetermined 
EO 13771 Designation: Regulatory 
CFR Citation: 21 CFR 212   
Legal Authority: 21 U.S.C. 351    21 U.S.C. 371   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  08/00/2018 
Regulatory Flexibility Analysis Required: Undetermined  Government Levels Affected: Undetermined 
Small Entities Affected: No  Federalism: Undetermined 
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