What is a veterinarian’s role in dispensing prescription animal drugs?

Federal law requires a veterinarian’s involvement to ensure prescription animal drugs are used safely. Section 503(f) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) states that prescription animal drugs can only be dispensed by or on the lawful order of a licensed veterinarian during their professional practice.  An animal prescription drug is not considered safe for use except under the skilled supervision of a licensed veterinarian. This is because of its toxicity or potential for harmful effects on humans or animals.
What does “dispensed by or on the lawful order of” mean?

In each instance, prescription animal drugs must be “dispensed by or upon the lawful written or oral order of a licensed veterinarian in the course of the veterinarian’s professional practice.” In addition to administering a drug at their practice or on-site, a veterinarian may dispense a prescription animal drug directly to the animal owner/caretaker (client) with appropriate directions for use or issue an order in a manner consistent with applicable Federal and State requirements, authorizing that a prescription animal drug be dispensed to an animal owner/caretaker (client) with appropriate directions for use.

What is meant by professional supervision or oversight?

The FDA determined that the prescription products could only be safely used with the supervision or oversight of a licensed veterinarian. Although the specific nature of the safety concern may vary by animal drug product, the underlying premise is that a licensed veterinarian has the necessary expertise and training to provide directions for the safe use of the product. The FDA expects the dispensing/authorizing veterinarian to take appropriate steps to ensure that such directions for safe use are provided/conveyed.

Can someone other than a licensed veterinarian dispense a prescription animal drug?

Given current Federal law and regulations, a licensed veterinarian’s direct involvement and oversight is required. As part of a team approach to veterinary medicine, a licensed veterinarian may direct staff, such as veterinary technicians, to dispense prescription animal drugs during their professional practice. However, Section 503(f) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) states that without a licensed veterinarian’s lawful written or oral order, it would be unlawful for anyone other than a licensed veterinarian to dispense prescription animal drugs.

What is a veterinarian’s role in extra-label use?

Extra-label use is when an approved animal drug is used in a manner that differs from the labeled directions or an approved human drug is used in animals. The FD&C Act authorizes the extra-label use of approved animal drugs under certain conditions. One condition is that such use is by or on the lawful order of a licensed veterinarian within the context of a valid veterinarian-client-patient relationship (VCPR). A veterinarian must have an established VCPR to prescribe the extra-label use of approved animal or human drugs and to issue a Veterinary Feed Directive (VFD) for a VFD drug. States may have additional requirements.

Can a Veterinarian-Client-Patient Relationship be established through telemedicine?

For 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 valuable tool for maintaining the VCPR.

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