FDA to Resume Enforcement of all Federal VCPR Requirements for Veterinary Telemedicine
The Food and Drug Administration announced on Dec. 21, 2022, its withdrawal of Guidance for Industry #269, “Enforcement Policy Regarding Federal VCPR Requirements to Facilitate Veterinary Telemedicine During the COVID-19 Outbreak."
The effective date of the decision is Feb. 21, which means that the FDA will again hold veterinarians to the federal requirements for the veterinarian-client-patient relationship beginning on that date. As stated by the FDA, the federal VCPR definition “requires animal examination and/or medically appropriate and timely visits to the premises where the animal(s) are kept” and “cannot be met solely through telemedicine.”
With the withdrawal of GFI 269, veterinarians using telemedicine to deliver patient care must be sure to establish a veterinarian-client-patient relationship that complies with federal requirements so they may, for example, issue a veterinary feed directive for a client.
GFI 269 was issued in March 2020 during the early days of the pandemic, when human illness and efforts to mitigate the spread of COVID-19 created challenges for in-person examinations of veterinary patients and the conduct of premise visits.
To help address these challenges and support the use of telemedicine to deliver patient care, GFI #269 indicated that the FDA would temporarily not enforce federal requirements for an in-person animal examination or premise visit to establish a VCPR for activities covered by the federal VCPR definition, including extralabel drug use and issuing veterinary feed directives.
Now, nearly three years later, the FDA says the conditions that created the need for the enforcement policy have evolved such that the policy is no longer needed. That means, as of Feb. 21, veterinarians will need to meet all the requirements of the federally defined VCPR, including an in-person examination or premise visit, to establish the relationship prior to engaging in covered activities. A VCPR that meets the federal definition cannot be established through telemedicine. Once established, the VCPR may be maintained via telemedicine between medically appropriate examinations and premise visits.