Guidelines for use of autogenous biologics
Autogenous biologics are USDA-regulated custom inactivated vaccines that consist of herd-specific (homologous) antigens approved for use by or under the direction of a veterinarian or approved non-veterinarian specialist. USDA can authorize the use of an autogenous biologic in adjacent and non-adjacent herds.
The use of autogenous biological products may provide the licensed veterinarian with a unique opportunity for the control of certain infectious diseases when USDA-licensed commercial vaccines are unavailable or not sufficiently cross protective.
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 should not be mixed with any other product. 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.
Autogenous biologics are regulated in accordance with Title 9 of the Code of Federal Regulations (9 CFR), Section 113.113 and Veterinary Services Memorandum No. 800.69.
Autogenous biologics are USDA-licensed products and should not be confused with products exempt under 9 CFR Part 107. For further information please see the AVMA policy on Guidelines for use of exempt biologics.