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HHS/FDA RIN: 0910-AG70 Publication ID: Spring 2011 
Title: ●Amendments to the Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals--Components 
Abstract: This rule proposes to amend regulations regarding the control over components used in manufacturing finished pharmaceuticals to increase assurance that each shipment conforms to expected quality specifications, was manufactured at a qualified facility, and was distributed in a controlled manner before receipt by the manufacturer of the finished pharmaceutical. 
Agency: Department of Health and Human Services(HHS)  Priority: Substantive, Nonsignificant 
RIN Status: First time published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: Undetermined  Unfunded Mandates: Undetermined 
CFR Citation: 21 CFR 210   
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 216, 42 USC 262, 42 USC 263a, 42 USC 264   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  01/00/2012    
Regulatory Flexibility Analysis Required: Undetermined  Government Levels Affected: Undetermined 
Small Entities Affected: Businesses  Federalism: Undetermined 
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: No 
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