CGA M-3

This publication is a guide for compliance with the applicable regulations of the U.S. Food and Drug Administra-tion (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.