FDA Issues Handbook for Vets on Antibiotics Sparing Human Health Bacteria
Published Date: 8/6/2026
Notice
Summary
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a final guidance for industry (GFI) #152 entitled "Evaluating the Safety of Antimicrobial New Animal Drugs with Regard to their Microbiological Effects on Bacteria of Human Health Concern." This guidance document informs interested parties about FDA's current method for evaluating potential microbiological effects of antimicrobial new animal drugs on bacteria of human health concern as part of the new animal drug application process.
Analyzed Economic Effects
3 provisions identified: 3 benefits, 0 costs, 0 mixed.
Final FDA Method for Drug Application Reviews
The FDA issued final Guidance for Industry (GFI) #152 describing the Agency's current method for evaluating potential microbiological effects of antimicrobial new animal drugs as part of the new animal drug application review process. The guidance was announced in the Federal Register on August 6, 2026.
Updated Appendix A Drug Importance Rankings
GFI #152 includes Appendix A rankings of medically important antimicrobial drugs into ‘critically important,’ ‘highly important,’ and ‘important’ for human medicine and states these rankings should inform one component of the risk assessment. The final guidance also explains why topical antimicrobials are excluded from the ranking.
Guidance Is Nonbinding; Alternatives Allowed
The guidance is Level 1 and represents FDA's current thinking, but it does not establish rights and is not binding on FDA or the public; you may use an alternative approach if it satisfies applicable statutes and regulations.
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