The U.S. Food and Drug Administration (FDA) drug registration and listing regulations, Title 21 of the U.S. Code of Federal Regulations (21 CFR) Part 207, do not address the unique properties of designated medical gas mixtures. Certain accommodations as presented in this position are made to conform with FDA’s requirements for electronic registration and listing submissions.
This position statement answers the following questions:
• What is the active ingredient for drug mixtures of designated medical gases?
• Because medical air is manufactured by two different methods (i.e., by compression and reconstitution) what is listed as the active ingredient for each method of manufacture?
• What is the active ingredient in drug mixtures of designated medical gases when air is used as the balance gas?
• How should concentrations of active ingredients be listed?