Blood-derived products demystified for equine practitioners

Historically, questions regarding equine blood, plasma, and serum products’ therapeutic claims, efficacy, safety, and regulatory oversight have been a source of potential confusion for equine practitioners.

Plasma transfusions are commonly administered to foals to supplement low immunoglobulin levels or to horses with coagulation disorders, for example.

However, these biological products are highly regulated, and practitioners may open themselves up to legal enforcement if they use illegally manufactured products.

Mare and newborn foal

The American Association of Equine Practitioners’ Infectious Disease Committee recently updated the association’s white paper on these products to help AAEP members in the U.S. and Canada navigate this area of veterinary medicine.

The authors point out differences between products regulated and licensed by the U.S. Department of Agriculture’s Center for Veterinary Biologics and products regulated by the Food and Drug Administration’s Center for Veterinary Medicine so equine veterinarians can make informed choices on product use. Companies may sell products regulated by both the USDA and the FDA.

In Canada, equine blood-derived products are regulated by the Canadian Centre for Veterinary Biologics of the Canadian Food Inspection Agency or the Veterinary Drugs Directorate of Health Canada. Currently, all Canadian-licensed plasma products are manufactured in the U.S., and all but one are licensed by the USDA.

The white paper, “USDA (United States Dept of Agriculture) and CFIA (Canadian Food Inspection Agency) Regulation of Equine Plasma & Serum Products for the Equine Practitioner,” emphasizes the fact that there are currently no FDA-licensed equine blood-derived products, so the paper focuses solely on USDA regulation of equine serum and plasma products.

The white paper provides a list of references containing general background information and guidance for clinical application, information on how a veterinarian can verify a licensed product with a specific therapeutic claim, and lists of USDA- and CFIA-licensed equine antibody products, of which there are less than 20 total.

“The AAEP and AVMA PLIT recommends that veterinarians use licensed products whenever possible, as these products have been tested and shown to be safe and effective for their labeled use(s),” the white paper states.

A version of this article appears in the October 2022 print issue of JAVMA.