Regulatory Brief

 The requiring of a warning label on biological products of equine serum or plasma origin intended for use in horses


Formal title: USDA Center for Veterinary Biologics Notice No. Draft-021; Lable Warning Statement for Serum and Plasma Products of Equine Origin


Summary:

The USDA Center for Veterinary Biologics released a draft notice stating that it would be requiring labeling for biological products of equine serum or plasma origin intended for use in horses.

The USDA would require all labels filed after January 1, 2007 to contain the following warning:

"The use of equine serum and plasma products has been associated with hepatic disease in horses. The administration of this product, particularly if routine or repeated, may increase this risk."

It is the opinion of the AVMA's Council on Biologic and Therapeutic Agents (COBTA) and Clinical Practitioner's Advisory Committee (CPAC) that there is insufficient data to support this labeling language. Though the AVMA is committed to the continued availability of products that are pure, safe, potent and efficacious for animals, it also encourages continued development and strengthening of the adverse events reporting system in order to obtain more and better data on which to make a more informed recommendation.

Response:

View AVMA's response to USDA(PDF) (January 5, 2007)

View USDA document (PDF)

Conclusion:

The CVB has no plans to go forward with the draft notice.