21 CFR §610.10
Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov ↗
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.