Guidelines for Autogenous Biologics

December 9, 2021

Recently, APHIS added to its website Veterinary Services (VS) Memorandum 800.69: Guidelines for Autogenous Biologics.

The VS Memorandum has been revised to address a number of industry and producer concerns.  Most notably, it increases the use of disease-causing microbiological isolates from 24 months to 60 months.  The other two major areas of revision are related to autogenous product distribution and the production of autogenous products from internationally sourced isolates.

This memorandum describes the procedures and guidelines for interpreting the requirements for autogenous biologics in title 9, Code of Federal Regulations (9 CFR), sections 113.113, 113.3(b)(8), and the administrative terminology in section 101.2.