Title 21

SECTION 207.3

207.3 Bulk drug substance.

§ 207.3 Bulk drug substance.

Bulk drug substance, as referenced in sections 503A(b)(1)(A) and 503B(a)(2) of the Federal Food, Drug, and Cosmetic Act, previously defined in § 207.3(a)(4), means the same as “active pharmaceutical ingredient” as defined in § 207.1(b).

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