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GMP Published

21 CFR Part 210 - Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; General

Establishes the status and applicability of the FDA's current good manufacturing practice regulations for drugs, and the definitions used throughout parts 211, 213, 225 and 226. Amended by 89 FR 51769 (18 June 2024, effective 18 December 2025) to add part 213 for medical gases.

Organisations:
FDA

Version Timeline

Chronological release history

89 FR 51769, June 18, 2024

Version milestone

Published

Publication Date

18 Jun 2024

Effective Date

18 Dec 2025