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Advocacy > Federal regulatory activities > Practice issues > Vaccines > Conditional labels
 
Federal regulatory practice issues: Vaccines
Updating label requirements for conditionally licensed vaccines
Formal title:
USDA Center for Veterinary Biologics (CVB) Notice No. Draft-004: Label Requirements for the Products Under Conditional Licenses
View USDA document (PDF, 1,030Kb)
Summary
The USDA CVB is proposing to update the label requirements for conditionally licensed vaccines, that is, those vaccines that are marketed with a reasonable expectation of efficacy in order to meet an emergency condition, limited market, local situation, or other special circumstance.

The AVMA commends the CVB for offering a proposal to differentiate labels of conditionally licensed vaccines from labels of fully licensed vaccines.
Response
View AVMA response to USDA (PDF) (June 6, 2005)
Conclusion
The CVB has no plans to go forward with the draft notice.