Drug

Drug has the meaning set forth in 3.2 of this chapter and includes medical gas as defined in section 575(2) of the Federal Food, Drug, and Cosmetic Act. Medical gas includes designated medical gases as defined in section 575(1) of the Federal Food, Drug, and Cosmetic Act and medical gases approved under section 505 of the Federal Food, Drug, and Cosmetic Act. A drug other than a medical gas that is a constituent part of a combination product is considered a drug product within the meaning of the drug current good manufacturing practice (CGMP) requirements. A drug that is a medical gas that is a constituent part of a combination product is considered a medical gas within the meaning of the medical gas CGMP requirements.

Source

21 CFR § 4.2

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Scoping language

The terms listed in this section have the following meanings for purposes of this subpart:

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