Regulatory Brief

 Including specific leptospiral serovar(s) on canine vaccine labels


Formal title: USDA Center for Veterinary Biologics (CVB) Draft Notice No. D011: True Name Change for Canine Vaccines with Bacterins Containing Leptospira

Summary:

The USDA Center for Veterinary Biologics proposes that all licenses, Outlines of Production, and labels for canine products containing Leptospira serovars will bear a True Name identifying each Leptospira serovar in the product, no later than October 1, 2008. Heretofore, labels did not specify the serovar.

The AVMA believes it is important for veterinarians to be able to identify a product's leptospiral serovars in order to make customized, science-based vaccination recommendations to dog owners.

The AVMA supports this CVB proposal and encourages further proposals that add clinically relevant, science-based content to biologic product labels.

Response:

Conclusion:

The USDA concluded that each Leptospira serovar contained in a biologic product will be identified in the product's True Name. Furthermore, acceptable abbreviations for four Leptospira serovars were identified.