21 CFR 610.10 - Potency.

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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.

Title 21 published on 13-Apr-2017 03:05

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 610 after this date.

  • 2016-08-08; vol. 81 # 152 - Monday, August 8, 2016
    1. 81 FR 52329 - Standard Preparations, Limits of Potency, and Dating Period Limitations for Biological Products; Confirmation of Effective Date
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Direct final rule; confirmation of effective date.
      Effective date of final rule published in the Federal Register of May 4, 2016 (81 FR 26687), confirmed: September 16, 2016.
      21 CFR Part 610
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