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. [81 FR 60212, Aug. 31, 2016, as amended at 86 FR 17061, Apr. 1, 2021]