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CGA PS-42

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

Position Statement by Compressed Gas Association , 01/31/2018

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Full Description

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.

 

Product Details

Edition:
3rd
Published:
01/31/2018
Number of Pages:
44
File Size:
1 file , 560 KB
Note:
This product is unavailable in Russia, Ukraine, Belarus
 

Document History

  1. CGA PS-42

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

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  2. CGA PS-42


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

    • Historical Version

  3. CGA PS-42


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

    • Historical Version