Guidelines for Use of Autogenous Biologics

Comment on this policyThe 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:

  1. Autogenous biologics (vaccines, bacterins, toxoids) are prepared at a USDA licensed establishment.
  2. Autogenous biologics are prepared with cultures of microorganisms taken from the affected herd of origin.
  3. Microorganisms must be identified. The first serial must be identified by genus. Subsequent serials must be identified by genus and species.
  4. Autogenous products may contain more than one microorganism isolated from the same herd.
  5. Autogenous products are inactivated and nontoxic.
  6. Autogenous products are tested for sterility and safety.
  7. Serials of autogenous products made within 24 months of isolation do not have potency or efficacy established. To have serials made after 24 months from isolation, additional testing is required to show antigenicity or immunogenicity.
  8. Autogenous biologics are licensed products prepared for use only by or under the direction of a veterinarian that has established and maintains a Veterinarian-Client-Patient relationship (VCPR).
  9. The Administrator may authorize use of an Autogenous biologic in adjacent and non-adjacent herds.
  10. Autogenous product serials carry an expiration date of 18 months from date of harvesting the serial.
  11. States may place further limitations on the distribution and/or use of biologics which must be observed.

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.

Related AVMA Policy:

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