In response to questions about requirements under federal law, the Food and Drug Administration (FDA) has addressed aspects of the Federal Food, Drug, and Cosmetic Act (FFDCA) pertinent to a veterinarian's role in prescribing animal drugs and the federal veterinarian-client-patient relationship (VCPR).

The FDA issued its "Dear Veterinarian" letter on September 4 as a reminder and educational effort for veterinarians.

A recent Food and Drug Administration Q&A directed at veterinarians says that "in each instance" a prescription animal drug can only be dispensed by, or on the lawful order of, a licensed veterinarian in the course of their professional practice.

In short, veterinarians are the only health care providers allowed to prescribe and dispense animal drugs. Plus, veterinarians must comply with the federal VCPR where it applies and, in those cases, it cannot be established through telemedicine. The VCPR can be maintained using telemedicine between physical examinations or timely and medically appropriate visits to the premises where the animal is kept.

Prescription guidelines

During the process of reviewing an application for the approval of a new animal drug (NDA), the FDA considers whether the drug must be marketed as a prescription drug, veterinary feed directive (VFD), or can be sold over the counter. Prescription status is required when the professional supervision of a licensed veterinarian is required for the safe and effective use of the drug or due to certain other factors.

The recent FDA Q&A indicates that "in each instance" a prescription animal drug can only be dispensed by, or on the lawful order of, a licensed veterinarian in the course of their professional practice.

For the FDA, "the underlying premise is that a licensed veterinarian has the necessary expertise and training to provide directions for the safe use of the product. Therefore, when a prescription animal drug is dispensed (or is authorized to be dispensed), FDA's expectation is that the dispensing/authorizing veterinarian takes appropriate steps to ensure that such directions for safe use are provided/conveyed." States may have additional expectations and requirements.

With a few groups pushing for a midlevel practitioner (MLP), who could diagnose, prescribe, and perform surgery after completing a mostly online master's program with minimal hands-on training, the FDA has been asked whether nonveterinarians can prescribe or dispense, acting under a compilation of protocols. In the document, the FDA clearly indicates that a MLP cannot legally prescribe or dispense under federal law, stating, "Given current federal law and regulations, a licensed veterinarian's direct involvement and oversight is required."

Veterinarians may, in the course of their professional practice, use their teams and direct staff, such as credentialed veterinary technicians, to dispense prescription animal drugs.

"Such directions to staff are consistent with the requirement that a prescription animal drug be 'dispensed by or upon the lawful written or oral order of a licensed veterinarian in the course of the veterinarian's professional practice,'" the document states.

However, the FDA clearly says that under federal law, "it would be unlawful for anyone other than a licensed veterinarian to dispense prescription animal drugs."

FDA's clarification that a MLP could not lawfully prescribe animal drugs comes nearly a week after Colorado's Secretary of State certified Ballot Initiative #145 that will ask Colorado voters in November whether the state should establish a MLP position called veterinary professional associate (VPA).

That means, if a VPA position were created, a licensed veterinarian would have to be directly involved in each instance to order and direct the VPA to dispense an animal drug, which is essentially what veterinary technicians and veterinary technician specialists already do.

VCPR requirements

Federal law also requires that a licensed veterinarian have an established, in-person VCPR, as defined by FDA's regulations, to prescribe the extralabel use of approved animal or human drugs, or to issue a VFD, the FDA said.

A second Colorado ballot initiative, which this summer failed to garner enough signatures to be placed on the November ballot, would have asked voters whether to allow a VCPR to be established via electronic means. The issue has recently come before state legislatures and veterinary medical boards with some trying to do away with a requirement for an in-person visit to establish a VCPR.

However, in response to the question "Can a veterinarian-client-patient relationship be established through telemedicine?" the FDA responded: "The federal VCPR definition (21 CFR 530.3(i)) includes the following requirement: 'The practicing veterinarian is readily available for follow-up in case of adverse reactions or failure of the regimen of therapy. Such a relationship can exist only when the veterinarian has recently seen and is personally acquainted with the keeping and care of the animal(s) by virtue of examination of the animal(s) and/or by medically appropriate and timely visits to the premises where the animal(s) are kept.' Therefore, for the purposes of the federal definition, a valid VCPR cannot be established solely through telemedicine (e.g., photos, videos, or other electronic means that do not involve examination of the animal(s) or timely visits to the premises). However, once a VCPR is established, telemedicine can be a useful tool for maintaining the VCPR."

The FDA encouraged veterinarians to "consult their state licensing boards to determine if there are additional requirements at the state or local level."

Currently, 42 states use language that is essentially the same as the FDA with respect to establishing a VCPR. Of those states that have mirrored the FDA's VCPR language, 22 have added additional language to explicitly require an in-person examination or visits to the location where animals are kept in order to establish the VCPR.

On the other hand, seven states and the District of Columbia have changed their veterinary practice acts or regulations to allow the state version of a VCPR to be established virtually or use telemedicine without an in-person examination. However, that does not mean that veterinarians can ignore the federal law. Veterinarians must comply with the in-person requirement to establish a federal VCPR everywhere that it applies. Failure to do so carries consequences, because the use of an animal drug is deemed unsafe and the drug adulterated if the requirement of the federal VCPR are not followed where it applies.

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