This publication applies to firms that engage in the filling, repackaging, transfilling, mixing, and/or -labeling of CMG classified as drugs by the FDA and applicable state agencies. Although it is a 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.