FDA Eases Enforcement to Expand Remote Care of Pets and Food-Producing Animals

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On March 24, 2020, the US Food and Drug Administration (“FDA”) issued Guidance[1] suspending the enforcement of certain veterinarian-client-patient relationship (“VCPR”) requirements to help veterinarians provide animal health services via telemedical means.

To allow veterinarians the ability to utilize telemedicine to address animal health needs during the COVID-19 outbreak, the FDA intends to temporarily suspend enforcement of a portion of the federal VCPR requirements. Specifically, enforcement of the requirements that the animal be examined physically and/or that the veterinarian must visit the location where the animal is kept are temporarily suspended for regulations governing Extralabel Drug Use in Animals (21 C.F.R. § 530) and the Veterinary Feed Directive Drugs (21 C.F.R. § 558.6).

The temporary change in enforcement of the Extralabel Drug Use allows veterinarians to prescribe drugs to an animal patient that are not approved for use in that particular species or are not approved for the illness presented by the animal without having to physically examine the animal or its premises. Using remote means, veterinarians thus may not only diagnose issues, but also treat them using the full scope of available drug treatments.

The FDA’s Veterinary Feed Directive Drug provisions regulate the use of certain drugs in animal feed, such as the use of antibiotics in the feed of cattle or other food-producing animals. The FDA’s Guidance now permits veterinarians to authorize the use of veterinary feed directive drugs for a group of animals following remote examination and diagnosis.

While the FDA is suspending enforcement of VCPR requirements at the federal level, it does not have the ability to suspend similar VCPR requirements at the state level. Thus, veterinarians should still consider their state VCPR requirements. We can assist with such review and clearance.

The COVID-19 crisis is obviously a fluid situation generating a multitude of issues on a daily basis. Seyfarth Shaw regulatory attorneys are closely monitoring the situation. We are available to protect your interests, help you mitigate risks and liabilities, and keep you informed regarding the latest implications related to the COVID-19 crisis. Visit our COVID-19 Resource Center for more information.

 

[1] The Guidance represents the FDA’s current thinking on this topic and does not establish any rights or responsibilities for any person.  It is not binding on the FDA or the public.  Indeed, the Guidance makes clear that it is intended to remain in effect only during the COVID-19 public health emergency declared by the Department of Health and Human Services and any renewals.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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