Publication

PS-42: CGA Position Statement on Appropriate and Effective Regulations for Medical Gases within 21 CFR Parts 201, 205, and 210/211

Abstract

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

Access Publication

Member Price:

$76

Subscriber Price:

$76

Non-Member Price:

$138

Member E-Pub Price:

Subscriber E-Pub Price:

Non-Member E-Pub Price:

$138

Buy Hard Copy

Purchase E-Pub

Properties

Edition:

Published:

January 2018

Status:

Available To the Public

Size:

44 pages

Publisher:

CGA

Special Attributes:

Notes:

Committee:

Medical Gases

Hard-copy publications
5 - 24 copies	15%
25 - 99 copies	30%
100 - 499 copies	45%
500+ copies	60%
Videos (AV series)
2 - 4 units	10%
5 - 9 units	20%
10 - 49 copies	35%
50+ units	50%
Exclusions
Libraries are not discounted
e-Pubs are not discounted because they are licensed to particular individuals, quantity is always 1

PS-42: CGA Position Statement on Appropriate and Effective Regulations for Medical Gases within 21 CFR Parts 201, 205, and 210/211

Abstract

Access Publication

Properties

Cataloging