Source: FDA
The U.S. Food and Drug Administration has finalized updated Guidance for Industry (GFI) #152, which outlines how the agency evaluates the potential human health risks of antimicrobial drugs intended for use in food-producing animals. The guidance focuses on antimicrobial resistance (AMR), which occurs when bacteria evolve to resist drugs used to treat infections. Because some antimicrobial classes are important in both human and Veterinary medicine, the FDA assesses whether their use in animals could contribute to resistant bacteria entering the food supply.
The updated guidance retains its qualitative risk assessment framework while revising Appendix A, which categorizes antimicrobial drugs as critically important, highly important, or important to human medicine. The FDA clarified that these rankings are intended to inform risk assessments, not serve as standalone risk management tools. Additional revisions include expanded hazard characterization, updated risk management language, and an explanation for excluding topical antimicrobials from the medical importance rankings.