Article courtesy of Bimeda

By June of 2023, the FDA under their guidance for the industry #263 (GFI 263) has requested that all medically important antimicrobials for use in animals, undergo a change in their approved marketing status from over-the-counter (OTC) to prescription (Rx). To ensure the appropriate or judicious use of medically important antimicrobial drugs in animals, the FDA recommends the following two principles: 1) limit medically important antimicrobial drugs to uses in animals that are considered necessary for assuring animal health, and 2) limit medically important antimicrobial drugs to uses in animals that include veterinary oversight or consultation.

The FDA is implementing GFI 263 as part of a broader effort to combat antimicrobial resistance which is a serious threat to both animal and public health. Because any antibiotic use can contribute to antibiotic resistance, it is important to avoid unnecessary or inappropriate use of these drugs. The expertise of the veterinarian is imperative to ensuring the responsible use of antimicrobial drugs in animals. Additionally, GFI 263 will protect the effectiveness of antimicrobials in people and animals while still ensuring these drugs are available when needed. This is based on the same guidance of GFI #209 (#213) which implemented the transition of medicated feed and drinking water to VFD or Rx in 2016.

The FDA believes that the judicious use of medically important antimicrobial drugs intended for use in animals should involve the scientific and clinical training of a licensed veterinarian. The FDA believes that veterinarians are uniquely qualified to make these decisions and to determine appropriately timed administration of the antimicrobial to treat, control, or prevent disease in animal. The involvement of a veterinarian is needed because use of these drugs requires an accurate diagnosis of the bacterial disease that is present, or likely to be present, and the selection of a suitable antimicrobial drug to address that disease.

Once this change is implemented, these medically important drugs can only be used in animals under the supervision of a licensed veterinarian, even if the animals are not intended for food production. Ultimately, this means that veterinarians will see a marked increase in calls and visits from owners seeking access to drugs they previously purchased at their local farm or pet store. Although specific requirements vary by state, veterinarians are generally not required to examine each individual animal for which a prescription is issued, as long as the veterinarian has established a valid VCPR with the farmer or rancher that owns or cares for the animal(s) in need of treatment.

It is important to note, that the official June 2023 date is required by FDA of the product manufacturers, not retailers or veterinarians. Meaning, the manufacturers will have transitioned labeling and packaging of all affected products by then, however FDA intends to allow existing inventory of OTC-labeled product that may already be in distribution channels to deplete.

Some examples of products that will be affected are Pro-Pen-G® (penicillin G procaine), Sustain III® Calf and Cattle Bolus (sulfamethazine), LincoMed® 100 & 300 (lincomycin, USP), SulfaMed™ (sulfadimethoxine), and SpectoGard® Scour-Chek (spectinomycin).

To learn more about GFI #263, visit https://www.fda.gov/animal-veterinary/cvm-updates/fda-finalizes-guidance-bring-remaining-approved-over-counter-medically-important-antimicrobial-drugs