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HHS/FDA

RIN: 0910-AA45

Publication ID: Fall 1995

Title: Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; Proposed Amendment of Certain Requirements for Finished Pharmaceuticals
Abstract: FDA is proposing revisions to the current good manufacturing practice (CGMP) regulations at 21 CFR parts 210 and 211 regarding finished pharmaceuticals. The new regulations either codify current agency policies or current industry practices. Among other things, the proposal would create or clarify requirements for process and methods validation, appropriate laboratory testing procedures, and protection against contamination. The proposal 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: Proposed Rule Stage
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 to 357 21 USC 360b 21 USC 371 21 USC 374

Timetable:

Action	Date	FR Cite
NPRM	12/00/1995

Additional Information: Previously reported under RIN 0905-AE63.
Regulatory Flexibility Analysis Required: No	Government Levels Affected: Federal
Included in the Regulatory Plan: No
Agency Contact: Thomas C. Kuchenberg Regulatory Counsel, Regulatory Policy Staff Department of Health and Human Services Food and Drug Administration Suite 3047 (HFD-7), Center for Drug Evaluation and Research, 1451 Rockville Pike, Rockville, MD 20852 Phone:301 594-2041