Viruses, Serums, Toxins, and Analogous Products; General Requirements for Inactivated Bacterial Products

We are amending the regulations to include a general standard requirement for inactivated bacterial products that is consistent with the general standard requirements [[Page 14354]] for live bacterial products, killed virus vaccines, and live virus vaccines. We are also including criteria and test concerning the identity of master seed. Finally, the amendment provides a choice of the most appropriate test methods, including identity tests, for the broad range of inactivated bacterial products available today. The final rule is necessary to update the current standards and provide uniform, relevant criteria for inactivated bacterial products.