21 C.F.R. § 610.10
Current through September 30, 2024
Tests for potency shall consist of either in vitro or in vivo tests, or both, which have been specifically designed for each product so as to indicate its potency in a manner adequate to satisfy the interpretation of potency given by the definition in § 600.3(s) of this chapter.
21 C.F.R. §610.10