THE BASICS
The federal government regulates veterinary medicine and animal drugs very differently than it does human health care and drugs intended for human use. This is, in part, because veterinarians are key to maintaining a healthy, safe, and wholesome food supply and because they also play an important role in overseeing the judicious use of antimicrobials in animals. One important difference between human and veterinary medicine is that the U.S. Food and Drug Administration (FDA) has authority under the federal Food, Drug and Cosmetic Act (FDCA) over the use of animal drugs and human drugs by veterinarians, and the authority to define how a veterinarian-client-patient relationship (VCPR) is established for certain uses of animal and human drugs.1 For these uses, FDA has authority to require the keeping of veterinary medical records and to access them at any reasonable time to verify and copy them.2 Use of animal and human drugs by veterinarians that violates the federal VCPR parameters set forth in the FDCA and its implementing regulations results in the drug being statutorily deemed unsafe for the use and, if in animal feed, the feed is statutorily deemed adulterated.3
The USDA, which regulates veterinary biological products, also has promulgated rules defining a VCPR using the same language as the FDA.4
APPLICATION OF THE FEDERAL VCPR
The federal VCPR applies to any use of an FDA-approved human drug in animals, including over-the-counter (OTC) human drugs.5 It applies to any use of an FDA-approved animal drug in any manner that di ers from its approved labeling (Extra Label Drug Use6), such as a different frequency of administration, different dose, different medical indication for its use, different route of administration, or use in a different species.7 It also applies to the use of compounded drugs by veterinarians8 and a veterinarian’s authorization of a veterinary feed directive (VFD).9 All of these are very common occurrences in the day-to-day practice of veterinary medicine.
Establishing the federal VCPR requires a physical examination of the animal or timely and medically appropriate visits to the premises where animals are kept. The FDA does not allow the VCPR to be established through electronic means.10 FDA does allow the VCPR to be maintained electronically through telemedicine.11 Veterinarians must comply with the federal VCPR in each of the circumstances in which it applies, irrespective of whether state law defines it differently.
The federal VCPR also applies in two important, but more limited, circumstances under USDA authorities. Veterinarians who manufacture biological products for use in their patients must do so within the context of the federal VCPR.12 Veterinarians also must have established a federal VCPR when using prescription platform product biologics, which are a new category of biotechnology vaccines.13
CONFLICTING STATE AND FEDERAL VCPR DEFINITIONS AND TELEMEDICINE
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