Oxygen

Yes — oxygen intended for medical use is classified as a drug by FDA and must meet pharmaceutical-grade standards, including CGMP compliance and proper labeling. Industrial oxygen used in steelmaking or chemical processes is not subject to FDA oversight but must still meet DOT transport requirements. Importers should confirm the intended use before entry.

Japan is the leading foreign supplier, followed by Mexico and Italy. France and Canada round out the top five. Supply is often tied to co-located industrial gas production facilities near major manufacturing customers.