This publication is a standard for compliance with the applicable regulations of the U.S. Food and Drug Administration (FDA) for the manufacture of compressed medical gases (CMG) classified as drugs as described in Title 21 of the U.S. Code of Federal Regulations (21 CFR). It outlines the requirements for manufacturing CMGs classified as drugs; however it may not contain all information necessary to comply with FDA regulations. It is the responsibility of each CMG manufacturer to ensure that their standard operating procedures (SOP) comply with all applicable federal, state, and local regulations.
This publication applies to firms that engage in the filling, repackaging, transfilling, mixing, and/or re-labeling of CMG classified as drugs by the FDA and applicable state agencies. Although it is primarily intended for firms engaged in the CMG manufacturing processes, portions may apply to firms that only distribute CMG classified as drugs.