FDA GFI 263: What You Need to Know

What You Need to Know

FDA’s GFI #263 aims to combat antimicrobial resistance, which threatens animal and public health. AMR arises from antimicrobial use in humans, animals, and horticulture.

Slowing down AMR development requires judicious use of antimicrobials across all settings. This will be effective June 1, 2023.

Why is this happening?

In the U.S., more than 2.8 million antimicrobial-resistant infections occur each year. 

What is antimicrobial resistance?

Antimicrobial resistance happens when germs like bacteria and fungi develop the ability to defeat the drugs designed to kill them. That means the germs are not killed and continue to grow. Resistant infections can be difficult, and sometimes impossible, to treat. Antibiotic usage in humans, animals, and horticulture can all contribute to resistant bacteria.

There are measures in place for human antimicrobial monitoring. Since antimicrobials are used in animals also, the FDA-Center for Veterinary medicine is focusing on animals and how this comes into play. 

U.S. Food & Drug Administration

For veterinarians

It is imperative for veterinarians to be aware that specific over-the-counter antibiotics now require a prescription, necessitating a veterinarian-client-patient relationship (VCPR). It is advisable for veterinarians to anticipate an increased number of inquiries from farmers and producers in relation to this guidance document.

VCPR: Veterinarian/Client/Patient Relationship

An appropriate veterinarian/client/patient relationship will exist when:

The veterinarian has assumed the responsibility for making medical judgments regarding the health of the animal(s) and the need for medical treatment, and the client (owner or other caretaker) has agreed to follow the instructions of the veterinarian;

There is sufficient knowledge of the animal(s) by the veterinarian to initiate at least a general or preliminary diagnosis of the medical condition of the animal(s). This means that the veterinarian is personally acquainted with the keeping and care of the animal(s) by virtue of:

  • (i) an examination of the animal by the veterinarian within the last twelve (12) months, or
  • (ii) medically appropriate and timely visits by the veterinarian to the premises where the patient is kept.;

A veterinarian/client/patient relationship cannot be established solely by telephone, computer, or other electronic means; however,

Once a veterinarian/client/patient relationship is established, it may be maintained telephonically, electronically, or by any other method of communication between:

  • In person medically necessary examinations; or,
  • Visits to the premises where the animal is kept, provided that it is within the periods of time that are appropriate for the medical issue in question and the species and age of the animal; and,
  • A failure to require in person examinations or visits in accordance with the minimum standard of care for the diagnosis, treatment, or other practice of veterinary medicine for an animal shall be considered unprofessional conduct.

A licensed veterinarian may provide advice and recommendations via electronic means in an emergency where death is imminent if an in-person examination of the patient will be conducted within 60 minutes of the provision of such advice or recommendations;…”

Rule 700-8-.01

Small Animal Veterinarians

Small animal practitioners will likely receive phone calls from existing clients who own goats, sheep, pigs, etc. This is an opportune time to determine how to handle these situations moving forward. If you have ever had an interest in branching out and seeing these kinds of patients, now may be the time to discuss this with your entire team. With pet ownership trends changing, now may be the perfect time to expand into mixed animal practice.

If you see small ruminants or large animals, we encourage you to reach out to your local extension agent.

For extension agents

Extension agents should also remain knowledgeable on this guidance as veterinarians and farmers/producers will likely be reaching out with questions.

Illness and infections are never convenient. Inform farmers/producers that the best time to talk to their vet is before livestock are sick. Planning ahead with a veterinarian
ensures them they can take care of their livestock in a timely manner when it matters most.

For farmers/producers

Establishing a collaborative partnership with a team of experts, including local livestock specialists, extension agents, and veterinarians, can help optimize limited resources such as time and finances, and subsequently enhance flock health and economic benefits.

The best time to talk to your vet is before your livestock are sick.

Under the FDA’s Guidance For Industry (GFI) #263, in June 2023 all medically important antibiotics that were previously available over-the-counter will require a prescription from a veterinarian for legal use in animals.

Make a proactive plan with a veterinarian to get the antibiotics your animals need when they need them:

  1. Talk to a vet
  2. Build a VCPR
  3. Schedule routine visits
  4. Set treatment protocols


Centers for Disease Control and Prevention, National Infection & Death Estimates for Antimicrobial Resistance
Rules and Regulations of the State of Georgia, Department 700. RULES OF GEORGIA STATE BOARD OF VETERINARY MEDICINE
FDA GFI #236