Veterinarian-Client-Patient Relationships, Prescribing/Dispensing Animal Drugs and Telemedicine

The FDA has received questions from interested parties about Federal requirements related to a veterinarian’s role in dispensing prescription animal drugs and to the establishment of a veterinarian-client-patient relationship (VCPR) in the course of practice. The following Q&As only cover the veterinarian’s obligations under Federal law. Veterinarians should also consult their state licensing boards to determine if there are additional requirements at the state or local level.

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

Federal law requires a veterinarian’s involvement to ensure that 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 in the course of their professional practice.  An animal prescription drug is one that is not safe for use except under the professional supervision of a licensed veterinarian because of its toxicity or potential for harmful effects, or because of the way it is used or other measures necessary for its use, or because the drug approval limits the drug to use under the professional supervision of a licensed veterinarian.  

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?

As part of the animal drug approval process, certain animal drug products are designated as prescription products because, among other reasons, FDA determined that the product could not be safely used without 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. 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 or more specific requirements. You can consult your state licensing board for more information about State specific requirements.

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, in the course of their professional practice, may direct staff, such as 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.”  However, Section 503(f) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) states without a lawful written or oral order of a licensed veterinarian, it would be unlawful for anyone other than a licensed veterinarian to dispense prescription animal drugs. 

What is a veterinarian’s role in extralabel use?

Extralabel 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. For example, extralabel use may be at a different dosage, in a different species, or to treat a different disease. The FD&C Act authorizes the extralabel use of approved drugs in animals 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). FDA regulations at 21 CFR 530.3(i) set out the definition of a valid VCPR.

A veterinarian must have an established VCPR to prescribe the extralabel use of approved animal or human drugs, and to issue a Veterinary Feed Directive (VFD) for a VFD drug.

States may have additional requirements. You can consult your state licensing board for more information about State specific requirements.

• For the extralabel use of approved animal or human drugs, the veterinarian must have a VCPR as defined in federal regulations at 21 CFR 530.3(i). 
• For a VFD drug, a veterinarian must issue the VFD in the context of a VCPR as defined by the State. However, if the State VCPR requirements do not include the key elements of a valid VCPR as defined in 21 CFR 530.3(i), the veterinarian must issue the VFD in the context of a valid VCPR as defined in federal regulations. See Does the State or Federal VCPR Definition Apply to a Lawful VFD in my State?

Is a VCPR required when approved animal drugs are used on label?

Federal law requires that a licensed veterinarian have an established VCPR to prescribe the extralabel use of approved animal or human drugs, and to issue a Veterinary Feed Directive (VFD) for a VFD drug. Although Federal law does not establish specific VCPR requirements related to the on-label use of approved animal drugs, you should consult your state licensing board for more information about State specific requirements. 

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

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.