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Federal regulatory practice issues: Vaccines

Improving vaccine expiration dating (stability)
Formal title:
Docket No. 04-064-1 Viruses, Serums, Toxins, and Analogous Products: Expiration Date Required for Serials and Subserials and Determination of Expiration Date of Product

View Federal Register document (PDF, 52 Kb)

Summary
The USDA is proposing to change the data criteria for vaccine expiration date assessment.

The AVMA recommends that USDA collect more stakeholder input before finalizing its decision. The AVMA is pleased that USDA is working to improve vaccine expiration dating, but the proposed regulations are written so broadly that it is difficult to determine the proposal's benefits and deficiencies.

Response
View AVMA's response to USDA (PDF)
Status
AVMA responded on June 27, 2005 and is awaiting publication of USDA response.