We are amending the Virus-Serum-Toxin Act regulations for certain live bacterial and viral vaccines by removing the requirement to retest the Master Seeds for immunogenicity 3 years after the initial qualifying immunogenicity test. In addition, we are amending the requirement concerning mouse safety tests prescribed for a biological product recommended for animals other than poultry. These changes update the standard requirements by eliminating unnecessary testing of Master Seed bacteria and viruses and other forms of bulk or completed biological product.
Document Subtype:
Final rule
Received Date:
December 21 2007, at 07:10 AM Eastern Standard Time
Viruses, Serums, Toxins, and Analogous Products; Standard Requirements for Live Vaccines
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