Autogenous biologics (vaccines, bacterins, toxoids) are prepared from cultures of microorganisms which are inactivated and nontoxic and provide the practitioner or APHIS CVB approved non-veterinarian specialist with a unique opportunity for the control of certain infectious diseases. Autogenous biologics are restricted to use by or under the direction of a licensed veterinarian within a veterinarian-client-patient relationship or by an approved non-veterinarian specialist under certain situations. Their use 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.
Veterinarians are exempt from the licensing requirements of the Virus-Serum-Toxin Act for those biologics they produce within their practice and use under a veterinarian-client-patient relationship. Autogenous biologics produced by the veterinarian should be tested to assure sterility, inactivation, and safety. This approach should be used only when the practice is equipped and staffed to carry out the required production procedures properly. Otherwise, autogenous biologics must be prepared in a USDA-licensed facility.
For regulatory guidance on autogenous biologics – please view 9CFR Sections 113.113 and 101.2 as well as VS Memos 800.69 and 800.103 – these documents are available at the USDA Center for Veterinary Biologics website: www.aphis.usda.gov/vs/cvb/regsandguidance.htm
The following points are important excerpts of the regulation – please refer to the guidance documents for specific regulations as they relate to autogenous biologics. Furthermore, consult the USDA licensed biologics manufacturer producing the autogenous product for additional information.