Animal and Plant Health Inspection Service December 21, 2007 – Federal Register Recent Federal Regulation Documents
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Viruses, Serums, Toxins, and Analogous Products; Standard Requirements for Live Vaccines
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.
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