Viruses, Serums, Toxins, and Analogous Products; State-Federal Licensure of Veterinary Biologics

Zusammenfassung

We are amending the regulations concerning State-Federal licensing of veterinary biological products. The effect of the amendment is that a Federally licensed establishment will not be allowed to produce the same veterinary biological product under both a State and Federal product license. Autogenous biologics will not be subject to the same requirement in that a Federally licensed establishment may hold both State and Federal product licenses for autogenous biologics, but must choose to produce each specific serial of such biologic under either a State or Federal product license. No autogenous biologic may be produced at the same time under both a Federal and State license. The amendment is necessary in order to ensure the integrity of the Federal licensing system and the safety of biological products produced in Federally licensed establishments. We are also removing outdated sections from the regulations referring to interim establishment licenses and exemption procedures that were permitted during the 5-year transition period to attain Federal licensure under the 1985 amendments to the Virus-Serum-Toxin Act.