Drug product

Drug product means an active ingredient in dosage form that has been approved or otherwise may be lawfully marketed under the Federal Food, Drug, and Cosmetic Act for distribution in the United States.


21 CFR § 1300.02

Scoping language

Any term not defined in this part shall have the definition set forth in section 102 of the Act (21 U.S.C. 802), except that certain terms used in part 1316 of this chapter are defined at the beginning of each subpart of that part.

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