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HHS/FDA RIN: 0910-AG04 Publication ID: Spring 2008 
Title: Amendment to the Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals 
Abstract: The Food and Drug Administration (FDA) is amending certain sections of 21 CFR parts 210 and 211 as the first phase of an incremental approach to modifying the current good manufacturing practice (CGMP) regulations for finished pharmaceuticals in 21 CFR parts 210 and 211. We are amending the regulations to modernize or clarify some of the CGMP requirements, as well as harmonize some of the CGMP requirements with those of other foreign regulators and other FDA regulations. These amendments are also consistent with current industry practice. We are taking this action as part of our continuing effort to revise outdated regulations without diminishing public health protection. 
Agency: Department of Health and Human Services(HHS)  Priority: Routine and Frequent 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Final Rule Stage 
Major: No  Unfunded Mandates: No 
CFR Citation: 21 CFR 210 to 211 
Legal Authority: 21 USC 321; 21 USC 351 to 352; 21 USC 355; 21 USC 360b; 21 USC 371; 21 USC 374 ; 42 USC 216; 42 USC 262; 42 USC 263a to 264 
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM-Companion to Direct Final Rule  12/04/2007  72 FR 68064 
Direct Final Rule  12/04/2007  72 FR 68113 
NPRM Comment Period End  02/19/2008   
Direct Final Rule; Withdrawal  04/04/2008  73 FR 18440 
Final Action  12/00/2008   
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
Agency Contact:
Brian L. Pendleton
Senior Policy Advisor
Department of Health and Human Services
Food and Drug Administration
Suite 3037 (HFD-7), Office of Policy, WO 32, Room 4245, 10903 New Hampshire Avenue,
Silver Spring, MD 20993-0002
Phone:301 796-4614
Fax:301 847-8616
Email: brian.pendleton@fda.hhs.gov

 
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