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HHS/FDA RIN: 0910-AA45 Publication ID: Spring 1999 
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 codify current agency policies or current industry practices. Among other things, the rule will 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: Other Significant 
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 211.22    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    21 CFR 211.113    21 CFR 211.115    21 CFR 211.160    21 CFR 211.166    21 CFR 211.192    21 CFR 211.220    ...     (To search for a specific CFR, visit the Code of Federal Regulations.)
Legal Authority: 21 USC 321    21 USC 351 to 352    21 USC 355    21 USC 360b    21 USC 371    21 USC 374   
Timetable:
Action Date FR Cite
NPRM  05/03/1996  61 FR 20104   
NPRM Comment Period End  09/30/1996    
Final Action  12/00/1999    
Additional Information: Previously reported under RIN 0905-AE63.
Regulatory Flexibility Analysis Required: Yes  Government Levels Affected: Federal 
Small Entities Affected: Businesses 
Included in the Regulatory Plan: No 
Agency Contact:
Richard Schwartzbard
Regulatory Counsel, Regulatory Policy Staff
Department of Health and Human Services
Food and Drug Administration
Suite 3037 (HFD-7), Center for Drug Evaluation and Research, 1451 Rockville Pike,
Rockville, MD 20852
Phone:301 594-2041
Fax:301 827-5562