§ 207.3. Bulk drug substance.
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/us/cfr/t21/s§ 207.3A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
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. [81 FR 60212, Aug. 31, 2016, as amended at 86 FR 17061, Apr. 1, 2021]
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§ 207.3
Bulk drug substance.
Fed. Reg.×29
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