21 C.F.R. § 610.10
Potency.
Cite as 21 C.F.R. § 610.10 (2026)
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.
- Cross-references to the CFR
- 600.3