21 CFR 610.10 - Potency.

§ 610.10 Potency.
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.

Title 21 published on 2013-04-01

no entries appear in the Federal Register after this date.