Autogenous Biologics Veterinarian Exemption Clarification
Formal Title: Viruses, Serums, Toxins, and Analogous Products; Exemptions from Preparation Pursuant to an Unsuspended and Unrevoked License (Docket No. APHIS–2011–0048)
The U.S. Department of Agriculture (USDA), Animal and Plant Health Inspection Service (APHIS) is proposing to amend the Virus-Serum-Toxin Act regulations to require that veterinary biologics prepared under the veterinary practitioner exemption must be prepared at the same facility the veterinarian utilizes in conducting the day-to-day activities associated with his or her practice. This exemption applies to veterinary biologics prepared by a veterinary practitioner solely for administration to animals in the course of a State-licensed professional practice of veterinary medicine under a veterinarian-client-patient relationship (VCPR).
This proposed amendment is necessary to ensure that veterinary biologics are not prepared in unlicensed establishments in violation of the Virus-Serum-Toxin Act. The effect of the proposed amendment would be to clarify the regulations regarding the preparation of product by a veterinary practitioner under a veterinarian-client-patient relationship.
The AVMA understands that the proposed rule would neither prevent veterinarians from obtaining autogenous vaccines from licenses biologics establishments in order to meet the health needs of animals that they treat within a VCPR, nor alter the current means by which autogenous vaccines can be utilized in the field. These two points are appreciated by veterinarians who utilize these tools to help safeguard the health of individual animals as well as the health of the nation’s herds and flocks in general. The AVMA is willing to work with USDA to enhance understanding by the veterinary profession on these issues.
The AVMA appreciates the regulatory clarification provided in the USDA’s Proposed Rule, which is closely aligned with AVMA’s Guidelines for Use of Autogenous Biologics policy. The AVMA asserts that autogenous biologics produced by a veterinarian under the parameters of the exemption 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. The AVMA also asserts that the use of autogenous biologics 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.
Final Rule Revision 9 CFR 107.1 Veterinary Practitioners and Animal Owners, effective July 10, 2015 (PDF)