Publication Details

[M-15] Standard for Appropriate and Effective Regulations for Medical Gases within 21 CFR Parts 201, 205, and 210/211



Abstract:

This standard reflects the Compressed Gas Association’s (CGA) consensus position for how the Federal Food and Drug Administration’s (FDA) regulations for finished pharmaceuticals found in Title 21 of the U.S. Code of Federal Regulations (21 CFR) Parts 201 (labeling), 205 (wholesale distribution), and 210 and 211 (GMPs), should be revised for designated medical gases or combinations thereof. This standard is consistent with established and long standing industry practice yielding safe and efficacious designated medical gases and consistent with the Congressional intent in the Food and Drug Administration Safety and Innovation Act’s (FDASIA) identifying the need for revisions to 21 CFR.

For 21 CFR Part 201 only those sub-parts and sections where CGA has submitted proposed modifications to the FDA for designated medical gases and combinations thereof are included. For 21 CFR Parts 205, 210, and 211, all subparts and sections are reproduced in this standard in their entirety with CGA’s proposed modifications for designated medical gases and combinations thereof.



Cataloging:

Category Medical Gases     Standards & Guidelines
Keywords medical gases
Related PS-42