Guidelines for Use of Autogenous Biologics

Comment on this policy

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.

  1. Autogenous biologics are not tested for potency or efficacy under USDA regulations.
  2. States may place further limitations on the distribution and/or use of biologics which must be observed.
  3. Regulations permit the use of multiple organisms for the preparation of autogenous biologics. 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.
  4. The product may be used in adjacent or non-adjacent herds or flocks considered to be at risk provided that the licensee has fulfilled all requirements and has documentation of such on file before shipping the product for use in another herd or flock. Records and documents relating to product shipments should be maintained for inspection by APHIS.
  5. Dating for autogenous products is regulated as follows:
    1. Microorganisms isolated from animals in a herd may be used for production of autogenous biologics for a period of 15 months from the date of isolation, not to exceed 12 months from the date of harvest of the first serial of product produced from the microorganisms.
    2. Extending the use of individual products up to 24 months will be permitted without requesting permission from APHIS CVB if all requirements for doing so have been met and are on file.
    3. For use past 24 months, CVB will evaluate each request and make the decision based on established requirements.
  6. Products produced by veterinarians for use in their own practices should bear labeling information which is adequate to assure safe and proper use of the product. At a minimum, the following information should be present.
    1. Name, address, and telephone number of the veterinarian
    2. Autogenous biologic, followed by the name of the microorganism(s) incorporated
    3. Vaccination schedule, which includes dosage, route of administration, number, and frequency of injections
    4. Expiration date and serial number
    5. Storage conditions
    6. Additional cautionary statements specified by the veterinarian.

Background: