The use of autogenous biological products may provide the licensed veterinarian with a unique opportunity for the control of certain infectious diseases. Understanding regulations for autogenous biologics is important to avoid violating the Virus Serum Toxin Act (VSTA) enforced by the United States Department of Agriculture (USDA).
The following guidelines are recommended for making decisions on the use of autogenous biologics in a veterinary practice:
The use of autogenous biologics requires the application of sound scientific principles and good veterinary practice in those situations where USDA-licensed, non-autogenous products are not available or there is evidence that licensed products are not effective. A thorough diagnostic work-up must be completed to provide the microorganism(s) for manufacture of the autogenous product. Autogenous biologics, as with all biologics, should not be mixed with any other product. The simultaneous administration of other products should be approached with caution. Veterinary practices utilizing autogenous products are advised to maintain product distribution information as part of the veterinary client/patient record to support restrictions for use in herd of origin.The 9 CFR 107, 112, and 113 and Veterinary Services Memo 800.69 which contain the regulations of veterinary biologics used in the United States, makes distinction between autogenous biologics and veterinary exempt biological products and should be consulted.
2015 American Veterinary Medical Association