AVMA Policy on Autogenous Biologics Consistent with Proposed USDA Rule

The U.S. Department of Agriculture (USDA) Animal and Plant Health Inspection Service’s (APHIS) recently  proposed rule to amend the Virus-Serum-Toxin Act regulations is consistent with the AVMA’s Guidelines for Use of Autogenous Biologics.  While the AVMA guidelines cover a wider range of issues, the proposed rule only addresses the existing regulations pertaining to veterinary biologics prepared under the veterinary practitioner exemption (9 CFR 107.1).  The AVMA submitted comments on Sept 13, 2012, in support of the proposed rule, which clarifies the specific regulations and closely aligns with AVMA guidelines.  It is important that veterinarians remain exempt from the licensing requirements of the Virus-Serum-Toxin Act for biologics they produce within their practice for specific animals under veterinarian-client-patient relationships (VCPRs).   Such biologics are vital in situations where USDA-licensed, non-autogenous products are either unavailable or there is evidence that licensed products are ineffective.

The proposed rule would not prevent veterinarians from obtaining autogenous vaccines from licensed biologics establishments in order to meet the health needs of animals that they treat within a VCPR, nor would it alter the current means by which autogenous vaccines can be utilized in the field [9 CFR 113.113 (Autogenous biologics),  9 CFR § 114.2 ( Products not prepared under license), Section 4.16  of the CVB’s Policy, Evaluation, and Licensing Reviewer's Manual, VS Memo 800.69 Guidelines for Autogenous Biologics (2009), etc.].  It would, however, amend the regulations to ensure that veterinary biologics are not prepared in unlicensed establishments in violation of the Virus-Serum-Toxin Act.  Additionally, it clarifies that veterinarians are not to contract for the commercial production and sales of the autogenous vaccines.

For more information please contact Dr. Kristi Henderson, assistant director, AVMA Scientific Activities Division.

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