Drug product

Drug product means a finished dosage form, e.g., tablet, capsule, or solution, that contains an active drug ingredient, generally, but not necessarily, in association with inactive ingredients. For purposes of this part, drug product also means biological product within the meaning of section 351(a) of the Public Health Service Act.

Source

21 CFR § 208.3

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Scoping language

For the purposes of this part, the following definitions shall apply:

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