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HHS/FDA RIN: 0910-AG20 Publication ID: Spring 2013 
Title: Amendment to the Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals--Second Phase 
Abstract: FDA will revise regulations for "current good manufacturing practice" for oversight and controls over the manufacture of drugs to ensure quality, including managing the risk of and establishing the safety of raw materials, materials used in the manufacturing of drugs, and finished drug products. This revision will update and harmonize requirements and improve detection and response to emerging product safety and quality signals. 
Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: Undetermined  Unfunded Mandates: Undetermined 
CFR Citation: 21 CFR 210; 21 CFR 211 
Legal Authority: 21 USC 321; 21 USC 351; 21 USC 352; 21 USC 355; 21 USC 360b; 21 USC 371; 21 USC 374; 42 USC 262; 42 USC 264 
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  01/00/2014   
Regulatory Flexibility Analysis Required: Yes  Government Levels Affected: None 
Small Entities Affected: Businesses  Federalism: No 
Included in the Regulatory Plan: No 
International Impacts: This regulatory action will be likely to have international trade and investment effects, or otherwise be of international interest.
RIN Data Printed in the FR: Yes 
Agency Contact:
Paula Katz
Regulatory Counsel, Office of Compliance
Department of Health and Human Services
Food and Drug Administration
Suite 3037 (HFD-7), Center for Drug Evaluation and Research, WO 51, Room 4314, 10903 New Hampshire Avenue,
Silver Spring, MD 20993
Phone:301 796-6972
Fax:301 847-8742
Email: paula.katz@fda.hhs.gov

 
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