• CGA PS-42

CGA PS-42

CGA Position Statement on Appropriate and Effective Regulations for Medical Gases within 21 CFR Parts 201, 205, and 210/211

Compressed Gas Association , 01/31/2018

Publisher: CGA

File Format: PDF

$69.00$138.00


This position statement reflects the Compressed Gas Association’s (CGA) consensus position for how the 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 position 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 (FDASIA) identifying the need for revisions to 21 CFR.

CGA PS-42 History

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CGA PS-42

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