State-Licensed Veterinarians may consider preparing biologics in their practice facility under a Veterinarian-Client-Patient Relationship in unique disease situations not adequately covered with USDA licensed biologics or autogenous products made at a USDA licensed establishment.
Preparation of exempt biologics is permitted by the Virus Serum Toxin Act (21 USC 151-159) (VSTA), specifically in paragraph 154a. The Secretary may exempt by regulation from the licensure and establishment requirements the preparation of any virus, serum, toxin, or analogous product prepared by any person, firm, or corporation (2) solely for the administration to animals under a veterinarian-client-patient relationship in the course of the State licensed professional practice of veterinary medicine. The regulation for exempt veterinary biologics is found in Chapter 9 of the Code of Federal Regulations Part 107 (9CFR 107.1).
9CFR 107.1(a) permits exempt veterinary biologics to be prepared by veterinarians in the following conditions:
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 products under 9CFR 107.1 have the following characteristics to keep in mind when considering the preparation of such products:
Standards for the preparation should be sufficient to: