Docket Number:
FDA-2003-D-0431
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

This guidance is intended to assist manufacturers of medical gases in complying with applicable current good manufacturing practice (CGMP) regulations (21 CFR parts 210 and 211). Medical gases are generally regulated as finished pharmaceuticals and are subject to CGMP requirements regardless of the processing stage. Compliance with applicable CGMP requirements helps to ensure the safety, identity, strength, quality, and purity of medical gases. Medical gases that are not manufactured, processed, packed, or held according to applicable CGMP requirements can cause serious injury or death.

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All written comments should be identified with this document's docket number: FDA-2003-D-0431.