Code of Federal Regulations · Section
§ 610.10 — Potency
21 C.F.R. § 610.10
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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.
Authorizing Statute
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Regulations42 U.S.C. § 216
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Definitions; generally21 U.S.C. § 321