GroundRules
21 CFR 610.10: Potency.
Where this section sits in the code
- Title 21—Food and Drugs
- CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
- SUBCHAPTER F—BIOLOGICS
- PART 610—GENERAL BIOLOGICAL PRODUCTS STANDARDS
- Subpart B—General Provisions
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.
Collected 2026-08-27T02:24:47Z. Source file · JSON