Registrant

Registrant means any person that owns or operates an establishment that manufactures, repacks, relabels, or salvages a drug, and is not otherwise exempt from establishment registration requirements under section 510 of the Federal Food, Drug, and Cosmetic Act or this part.

Source

21 CFR § 207.1

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Scoping language

The definitions and interpretations of terms in sections 201 and 510 of the Federal Food, Drug, and Cosmetic Act apply to the terms used in this part, if not otherwise defined in this section. The following definitions apply to this part:

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