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HHS/FDA RIN: 0910-AH09 Publication ID: Spring 2014 
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: Other Significant 
RIN Status: First time published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: Undetermined  Unfunded Mandates: Undetermined 
CFR Citation: Not Yet Determined (To search for a specific CFR, visit the Code of Federal Regulations.
Legal Authority: 21 USC 351; PL 113-54, 127 Stat 587; 21 USC 371 
Legal Deadline:
Action Source Description Date
Final  Statutory  Not more than 18 months following publication of the proposed rule.   

Overall Description of Deadline: Section 104 of the Drug Quality and Security Act (DQSA) requires that in promulgating any regulations to implement the DQSA (e.g., section 503B of the FD&C Act), at least 60 days be provided for comments on a proposed regulation and the final regulation be published not more than 18 months following publication of the proposed rule and not less than 30 calendar days before the effective date of such final regulation.

Timetable:
Action Date FR Cite
NPRM  11/00/2014   
Regulatory Flexibility Analysis Required: Undetermined  Government Levels Affected: Undetermined 
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
10903 New Hampshire Avenue, Building 51, Room 4192,
Silver Spring, MD 20993
Phone:301 796-6341
Email: ashley.boam@fda.hhs.gov

 
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