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HHS/FDA RIN: 0910-AA45 Publication ID: Fall 2001 
Title: Current Good Manufacturing Practice; Amendment of Certain Requirements for Finished Pharmaceuticals 
Abstract: FDA is finalizing revisions to the current good manufacturing practice (CGMP) regulations at 21 CFR parts 210 and 211 regarding finished pharmaceuticals. The new regulations will codify certain current agency policies and current industry practices. The rule will, among other things, create or clarify requirements for process and methods validation, appropriate laboratory testing procedures, and protection against contamination. The rule is designed to update the CGMP regulations in response to technological changes and the agency's experience with the regulations. 
Agency: Department of Health and Human Services(HHS)  Priority: Substantive, Nonsignificant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Final Rule Stage 
Major: No  Unfunded Mandates: No 
CFR Citation: 21 CFR 210.3    21 CFR 211.113    21 CFR 211.160    21 CFR 211.165    21 CFR 211.166    21 CFR 211.180    21 CFR 211.192    21 CFR 211.220    21 CFR 211.222    21 CFR 211.240    21 CFR 211.22    21 CFR 211.68    21 CFR 211.82    21 CFR 211.84    21 CFR 211.101    21 CFR 211.103    21 CFR 211.110    21 CFR 211.111    ...     (To search for a specific CFR, visit the Code of Federal Regulations.)
Legal Authority: 21 USC 321    21 USC 351    21 USC 352    21 USC 355    21 USC 360b    21 USC 371    21 USC 374   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  05/03/1996  61 FR 20104   
NPRM Comment Period End  09/30/1996    
Final Action  07/00/2002    
Regulatory Flexibility Analysis Required: Undetermined  Government Levels Affected: None 
Federalism: No 
Included in the Regulatory Plan: No 
Agency Contact:
Howard P. Muller
Office of Regulatory Policy
Department of Health and Human Services
Food and Drug Administration
Suite 3037 (HFD-7), Center for Drug Evaluation and Research, WO 51, Room 6234, 10903 New Hampshire Avenue,
Silver Spring, MD 20993-0002
Phone:301 796-3601
Fax:301 847-8440
Email: howard.mullerjr@fda.hhs.gov