21 CFR 610.14 - Identity.

§ 610.14 Identity.

The contents of a final container of each filling of each lot shall be tested for identity after all labeling operations shall have been completed. The identity test shall be specific for each product in a manner that will adequately identify it as the product designated on final container and package labels and circulars, and distinguish it from any other product being processed in the same laboratory. Identity may be established either through the physical or chemical characteristics of the product, inspection by macroscopic or microscopic methods, specific cultural tests, or in vitro or in vivo immunological tests.

Title 21 published on 10-May-2017 03:43

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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