Drug product

(4) Drug product means a finished dosage form, for example, tablet, capsule, solution, etc., that contains an active drug ingredient generally, but not necessarily, in association with inactive ingredients. The term also includes a finished dosage form that does not contain an active ingredient but is intended to be used as a placebo.

Source

21 CFR § 210.3

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Scoping language

The definitions and interpretations contained in section 201 of the act shall be applicable to such terms when used in this part and in parts 211, 225, and 226 of this chapter.

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