21 C.F.R. § 610.10   Potency.


Title 21 - Food and Drugs


Title 21: Food and Drugs
PART 610—GENERAL BIOLOGICAL PRODUCTS STANDARDS
Subpart B—General Provisions

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§ 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 §600.3(s) of this chapter.

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