Guidelines for use of exempt biologics

State-licensed veterinarians may consider preparing biologics in their practice facility under a veterinarian-client-patient-relationship (VCPR) in unique disease situations not adequately covered with USDA-licensed biologics or autogenous products made at a USDA-licensed establishment. All steps in preparing the biologic must be performed in the facilities that the veterinarian uses for day-to-day activities associated with the treatment of animals in the course of the state licensed practice of veterinary medicine. Records supporting the VCPR justifying the exemption should be kept. State-licensed veterinarians are advised to contact the USDA when considering preparation of these products.

Exempt production of biologics is not exempt from the provisions of the Virus-Serum-Toxin Act or from USDA inspection or USDA review of records. In addition, exempt production of biologics may be subject to State regulations and approval. Exempt biological product labeling should be truthful, complete, and accurate (including dosage, route of administration, and directions), show date of production and storage conditions, and provide contact information for the preparing veterinarian.

Before preparing biologics for use in their practice, veterinarians are encouraged to check with their malpractice insurance provider to determine whether the preparation of biologic products is covered under their professional liability insurance policy and/or whether it is advisable to obtain separate product liability coverage.

Exempt biological products are regulated in accordance with Title 9 of the Code of Federal Regulations, Part 107.