The Veterinary Services (VS) division of the USDA’s Animal and Plant Health Inspection Service (APHIS) recently issued a memorandum detailing its Guidelines for Autogenous Biologics.
According to an earlier APHIS document, “autogenous biologics” are defined as custom vaccines that consist of herd-specific (homologous) antigens. They are licensed products, produced in a licensed facility, according to an approved Outline of Production.
The memorandum describes the present procedures and guidelines for interpretation of the requirements for autogenous biologics under the provisions of Title 9, Code of Federal Regulations 113.113. According to the guidelines, licensees can use autogenous isolates for 24 months without requesting permission from the APHIS/VS Center for Veterinary Biologics (CVB). Also, licensees can ship autogenous vaccines to adjacent and nonadjacent herds, provided the information cited in the Code of Federal Regulations and is on file with the licensee prior to the shipment of an autogenous product for use in a herd other than the herd of origin.
Key points in the guidelines include:
Non-veterinarian specialists can prepare autogenous biologics in special situations if approved by the Administrator. The CVB-IC will use professional judgment in determining whether the person has the appropriate expertise to administer the product and deal with possible medical problems.
Microorganism used for the production of an autogenous biologic may not be older than 15 months from the date of isolation.
The law allows extended use of an isolate beyond 15 months from the date of isolation. Extensions to 24 months will be permitted without requesting permission from the CVB, provided the firm has specific information on file. A list of the necessary information is included in the memorandum.
Extensions beyond 24 months are evaluated by the Center for Veterinary Biologics, based on the information on file, immunogenicity data and a proposed potency test.
Microorganisms used to prepare autogenous biologics shall not be maintained in a licensed establishment beyond the time authorized for use in production. Outdated isolates must be handled in accordance with 9 CFR 114.15 and VS Memorandum No. 800.56. Records of the disposition of isolates must be maintained as provided in 9 CFR section 116.
Read the VS Memorandum 800.69 (Guidelines for Autogenous Biologics) online.
APHIS/VS also provides an overview of autogenous biologics, including technical definitions associated with their production and use.