21 C.F.R. § 610.10

Potency.

Last amended: 2016Year: 2026Length: 49 wordsOfficial source

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
21 C.F.R. § 610.10: Potency. | Justis AI