Drugmakers will have two years to change the sales availability of some medically important livestock antimicrobials to prescription-only, said the Food and Drug Administration on Thursday. The shift from over-the-counter sales would mean the drugs can be used only under veterinary supervision, said the agency in finalizing its Guidance for Industry No. 263.
The new document follows GFI No. 213, which ended the use of medically important antibiotics to help cattle, hogs, and poultry gain weight. The drugs remain available for disease prevention and treatment. The controls on the use of antimicrobials on food-bearing animals are part of a comprehensive effort by government and the health sector to preserve the effectiveness of antibiotics in human medicine.
When GFI No. 213 took effect in 2017, 96 percent of medically important antimicrobials used in livestock and companion animals were placed under the supervision of licensed veterinarians. The remaining 4 percent included other dosage formats, such as injectables and topicals. GFI No. 263 will steer those into the sphere of veterinary oversight, said the FDA.
A “frequently asked questions” sheet for farmers and ranchers is available here.
Guidance for Industry No. 263 is available here.