What veterinarians should know about GFI#263

By Dr. Bruce Hutton, Washington State Department of Agriculture, Region 3 Field Veterinarian


Misuse or overuse of antibiotics in human and veterinary health care, as well as food production medicine, is a major inciting cause of antimicrobial resistance leading to a serious threat to both human and animal health worldwide. Recognizing the significant human health concerns caused by resistant pathogens, the CDC released the national strategy for combating antibiotic-resistant bacteria in September of 2014. This document was intended as an action plan designed to develop a strategy to slow the emergence of resistant bacteria through surveillance, diagnostics, research, and collaboration between stakeholders. As a result, two Guidance for Industry (GFI) documents were developed (GFI #209 and GFI #213). GFI #209 dealt broadly with the judicious use of antimicrobials in food-producing animals, whereas GFI #213 more specifically targeted the use of medically important antimicrobials in the feed and water of food-producing animals. In 2017, the implementation of GFI #213 effectively eliminated the use of medically important antimicrobials for growth promotion in the feed or water of food-producing animals. In addition, it required a Veterinary Feed Directive (VFD) for medically important antimicrobials added to feed, and a prescription for medically important antimicrobials added to water when used to prevent, treat, or control a specific condition.

Building on GFI #209 and #213, in 2018 the FDA center for veterinary medicine released a 5-year plan designed to raise awareness of antimicrobial resistance and provide a guide for antimicrobial oversight in veterinary settings. A component of this plan was to issue and implement a strategy to convert all dosage forms of over-the-counter (OTC) medically important antimicrobial drugs approved for use in food-producing animals to veterinary prescription status. On June 10th, 2021, the FDA finalized GFI #263 which outlines the processes necessary to accomplish this task. GFI #263 placed a 2-year deadline on implementation which means that by June 11th, 2023, all medically important antimicrobials approved for animal use will require a veterinary prescription.


So, what does all this mean for food animal veterinarians. In June of 2023 producers who are used to treating their own animals will now be required to obtain a veterinary prescription prior to purchasing medically important antimicrobials which were previously available without a prescription. There are a handful of OTC medications in various formulations which will transfer to prescription status when GFI #263 is implemented in June of 2023. They include sulfas, penicillin, oxytetracycline, tylosin, lincomycin, and the intermammary tubes ToDay and ToMORROW. As we all know, veterinarians are required to establish a valid VCPR prior to issuing a prescription. According to the WVMA board of governors, a VCRP exists when the veterinarian:

  • Has assumed responsibility for making clinical judgments about the patient, and the client or key party has agreed to follow the instructions of the veterinarian.
  • Has sufficient knowledge of the animal(s) to generate a preliminary diagnosis. For herd health, this can be done through examination of records, consultations with operations’ management personnel, and understanding of local epidemiology of diseases. Having sufficient knowledge means the veterinarian:
    • Has examined the animal(s) in the last 12 months or sooner if appropriate.
    • Is personally acquainted with the keeping and care of the animal(s) by virtue of an examination of the animal(s) or by medically appropriate and timely visits to the premises where the animal(s) are kept (in cases involving operations with several animals, such as encountered at farms, laboratories, or in shelters).
    • Is readily available for follow-up and continued care or has arranged for emergency coverage and continuing care and treatment.

The impact of GFI #263 on veterinarians should be minimal as existing clients requiring prescription medications should already have a valid VCPR. There may be a slight uptick as owners who only irregularly use veterinary services realize they do not have the valid VCPR required to obtain a prescription. Confounding the problem is the shortage of food animal veterinarians especially in rural areas which may make the establishment of a VCPR difficult. Client and community education between now and June 2023 would help to alleviate problems. Food animal veterinarians should be actively involved in engaging and promoting the transition well before the June 2023 deadline.

Why should we change

First and foremost, veterinarians as health care providers should embrace the one health concept. There are numerous antimicrobials used in both veterinary and human health care settings. Their misuse, in either setting, promotes antimicrobial resistance which has global negative animal and human health effects. Removing OTC medications from the shelf and requiring their use on or by the order of a licensed veterinarian provides an extra layer of oversight. The use of OTC antimicrobials in food animals has a long tradition. It is almost a badge of honor for an owner to report they have not used a veterinarian for years. Unfortunately, seasoned food animal practitioners could easily fill a book with “what the heck were they thinking” stories of antimicrobial misuse by lay persons. Food animal veterinarians working under a VCPR are uniquely positioned to promote judicious antimicrobial use through client education and prescribing antimicrobials only when necessary. A veterinarian’s knowledge of antimicrobial use including choice of antibiotic, dose, duration, and route of administration is critical to ensuring the proper use of antibiotics in animals.

Lastly, producers and veterinarians should understand that consumer attitudes toward food animal production systems are changing. Conventional programs utilizing hormones or antimicrobials for disease prevention and growth promotion are less accepted in the marketplace. Extreme programs such as the No Antibiotics Ever (NAE) program used in poultry production are effective but can have unintended consequences (see Mississippi State Extension site). Consumers are bombarded daily about perceived problems within the US food production industry. The food animal industry, including food animal veterinarians and producers, should take the helm and promote balanced programs such as the Certified Responsible Antibiotic Use (CRAU) program.

The U.S. Food and Drug Administration’s Center for Veterinary Medicine (CVM) has developed some materials that you might find helpful. Below are links for species-specific fact sheets – these include information on products/indications that will be transitioning as part of GFI 263 and information on how interested animal owners can locate a vet. Also linked below are a brochure and poster which detail the importance of veterinary involvement as products transition to Rx.

  1. Antibiotic Stewardship in Veterinary Medicine Brochure – https://www.fda.gov/media/162067/download
    1. Español – https://www.fda.gov/media/162068/download
  2. Antibiotic Stewardship Poster – https://www.fda.gov/media/162075/download
    1. Español – https://www.fda.gov/media/162076/download
  3. Antibiotic Stewardship in Beef and Dairy Cattle – https://www.fda.gov/media/162069/download
    1. Español – https://www.fda.gov/media/162070/download
  4. Antibiotic Stewardship in Poultry – https://www.fda.gov/media/162071/download
    1. Español – https://www.fda.gov/media/162072/download
  5. Antibiotic Stewardship in Sheep and Goats – https://www.fda.gov/media/162073/download
    1. Español – https://www.fda.gov/media/162074/download
  6. In addition, CVM has posted a list of affected applications on its website as well as a Farmer and Rancher Q&A.