21 CFR 610.10 - Potency.

§ 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 2014-04-01

no entries appear in the Federal Register after this date.

Title 21 published on 2014-04-01

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

  • 2014-08-22; vol. 79 # 163 - Friday, August 22, 2014
    1. 79 FR 49727 - Revocation of General Safety Test Regulations That Are Duplicative of Requirements in Biological License Applications
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Proposed rule.
      Submit either electronic or written comments on this proposed rule by November 20, 2014. See section V of this document for the proposed effective date of any final rule that may publish based on this proposal.
      21 CFR Parts 610 and 680