scope:

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.

This publication does not apply to:

- bulk air separation manufacturing and distribution facilities that produce United States Pharmacopoeia/ National Formulary (USP/NF) products;

- bulk carbon dioxide USP manufacturing and distribution facilities;

- bulk helium USP manufacturing and distribution facilities;

- bulk nitrous oxide USP manufacturing and distribution facilities;

- drugs that are defined as Investigational New Drug Applications, e.g., a gas or gas mixture that has never been previously used as a drug, New Drug Applications, or Amended New Drug Applications by the Federal Food, Drug, and Cosmetic Act (the Act) [2]; 

-  medical gases classified by FDA as medical devices as defined by the Act [2];

- gases labeled for industrial use and recreational applications, e.g., diving gases, self-contained breathing apparatus, aviator's breathing oxygen; or

- refrigerated liquid oxygen USP that is filled at a patient's residence or is filled, repackaged, transfilled, and/or relabeled by home respiratory care companies.