designated medical gas
(1) A designated medical gas means a drug that: (i) Is manufactured or stored in a liquefied, nonliquefied, or cryogenic state; (ii) Is administered as a gas; and (iii) Meets the definition in section 575(1) of the Federal Food, Drug, and Cosmetic Act. (2) A final use container means a container that is for direct use or access by a patient or healthcare provider to administer a designated medical gas or medically appropriate combination of designated medical gases. The term final use container does not include bulk or transport containers and does not include containers that are described in 868.5655 of this chapter. (3) A bulk or transport container means a container used to transport or store designated medical gases or medically appropriate combinations of designated medical gases and that is not used directly to administer such gases to a patient.