Part 213 — Current Good Manufacturing Practice for Medical Gases
Current through Sep 8, 2026
Authority: 21 U.S.C. 321, 351, 352, 353, 355, 360b, 360ddd, 360ddd-1, 371, 374.
Source: 89 FR 51770, June 18, 2024, unless otherwise noted.
Sections
- § 213.1 Scope.
- § 213.3 Definitions.
- § 213.22 Responsibilities of quality unit.
- § 213.25 Personnel qualifications and responsibilities.
- § 213.34 Consultants.
- § 213.42 Design and construction features.
- § 213.63 Equipment design, size, and location.
- § 213.65 Equipment construction.
- § 213.67 Equipment maintenance and cleaning.
- § 213.68 Automatic, mechanical, and electronic equipment.
- § 213.80 General requirements.
- § 213.82 Receipt and storage of incoming designated medical gases.
- § 213.84 Testing and approval or rejection of components, containers, and closures.
- § 213.89 Rejected components, incoming designated medical gases, and medical gas containers and closures.
- § 213.94 Medical gas containers and closures.
- § 213.100 Written procedures; deviations.
- § 213.101 Charge-in of components and incoming designated medical gases.
- § 213.110 Sampling and testing of in-process materials.
- § 213.122 Materials examination and usage criteria.
- § 213.125 Labeling issuance.
- § 213.130 Packaging and labeling operations.
- § 213.150 Warehousing and distribution procedures.
- § 213.160 General requirements.
- § 213.165 Testing and release for distribution.
- § 213.166 Stability testing and expiration dating for medical gases marketed under applications submitted under section 505 or section 512 of the Federal Food, Drug, and Cosmetic Act.
- § 213.180 General requirements.
- § 213.182 Equipment cleaning and use log.
- § 213.184 Records for components, medical gas containers and closures, and labeling.
- § 213.186 Master production and control records.
- § 213.189 Batch production and control records.
- § 213.192 Production record review.
- § 213.194 Laboratory records.
- § 213.196 Distribution records.
- § 213.198 Complaint files.
- § 213.204 Returned medical gases.
- § 213.208 Salvaging of medical gases.