Code of Federal Regulations (alpha)

CFR /  Title 21  /  Part 610  /  Sec. 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 Sec. 600.3(s) of this chapter.