Release Requirements

  1. Law
  2. CFR 21
  3. Food and Drugs
  4. Food and Drug Administration, Department of Health and Human Services
  5. Biologics
  6. General Biological Products Standards
  7. Release Requirements

Checkout our iOS App for a better way to browser and research.

Section
610.1

Tests prior to release required for each lot.

Section
610.2

Requests for samples and protocols; official release.