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HHS/FDA RIN: 0910-AG70 Publication ID: Spring 2013 
Title: Amendments to the Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals--Components 
Abstract: FDA will revise regulations for "current good manufacturing practice" with regard to the control over components used in manufacturing finished pharmaceuticals. 
Agency: Department of Health and Human Services(HHS)  Priority: Economically Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: Yes  Unfunded Mandates: Private Sector 
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 360bbb-7    21 USC 371    21 USC 374    42 USC 262    42 USC 264   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  07/00/2013 
Additional Information: Includes Retrospective Review under E.O. 13563.
Regulatory Flexibility Analysis Required: Yes  Government Levels Affected: Federal 
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:
Brian Hasselbalch
Consumer Safety Officer
Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research, WO 51, Room 4364, 10903 New Hampshire Avenue,
Silver Spring, MD 20993
Phone:301 796-3279
Email: brian.hasselbalch@fda.hhs.gov

Paula Katz
Consumer Safety Officer
Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research, WO 51, Room 1320, 10903 New Hampshire Avenue,
Silver Spring, MD 20993
Phone:301 796-6972
Email: paula.katz@fda.hhs.gov