Regulatory Brief

 Guidelines for Autogenous Biologics


Formal title: Draft No. 335 - Guidelines for Autogenous Biologics

The United States Department of Agriculture (USDA) Animal and Plant Health Inspection Service (APHIS) Center for Veterinary Biologics (CVB) is providing guidelines to describe present procedures and guidelines for interpretation of the requirements for Autogenous Biologics.

Brief Description:

The CVB is providing guidelines to describe present procedures and guidelines for interpretation of the requirements for Autogenous Biologics under the provisions of Title 9, Code of Federal Regulations (9 CFR), Section 113.113, 113.3(b)(8), and the administrative terminology in Section 101.2. The purpose of the guidelines is to inform licensees that autogenous isolates may be used for 24 months without requesting permission from CVB and to notify licensees that shipments to adjacent and nonadjacent herds will be permitted, provided the information cited in 113.113(a)(2) and (3) 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.

AVMA Response:

The AVMA recognizes the potential resource savings by the CVB with the changes proposed in the draft. The AVMA understands that extensions for isolate use beyond 15 months has been sought and approved for the majority of autogenous biologics in recent history. The AVMA also understands that nearly all submissions of data to support non-adjacent use of isolates are approved by CVB, saving the Center resources if autogenous manufacturers no longer have to submit data to support such non-adjacent use.

The AVMA acknowledges the on-site utilization by a range of specialists within various animal health programs (of autogenous biologics). The AVMA supports the draft's requirement for certification of a valid veterinarian-client-patient relationship as defined by AVMA policy.

Background Documents:

View AVMA's response to USDA (PDF)

View USDA Document

Status:

AVMA responded on June 1, 2009