Historical
CGA M-3-2015
Standard for the Manufacturer of Bulk Medical Gases - 4th Edition
This publication is a standard for compliance with the applicable regulations of the U.S. Food and Drug Administration (FDA) for the manufacture of bulk medical gases classified as drugs as described in Title 21 of the U.S. Code of Federal Regulations (21 CFR) [1].1 It outlines the requirements for manufacturing bulk medical gases classified as drugs; however, it may not contain all information necessary to comply with FDA regulations. It is the responsibility of each gas manufacturer to ensure that their standard operating procedures (SOP) comply with all applicable federal, state, and local regulations.
Content Provider
Compressed Gas Association, Inc. [cga]
