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e-CFR data is current as of March 4, 2021 |
Title 21 → Chapter I → Subchapter F → Part 610 → Subpart B → §610.10 |
Title 21: Food and Drugs
PART 610—GENERAL BIOLOGICAL PRODUCTS STANDARDS
Subpart B—General Provisions
§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.