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# Antimicrobial Animal Drug Finalized Safety Guidance
- URL: https://www.fdaweb.com/antimicrobial-animal-drug-finalized-safety-guidance/
- Published: 2026-08-05T12:00:00.000Z
- Updated: 2026-09-14T13:44:34.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5161579

FDA has finalized a guidance, *Evaluating the Safety of Antimicrobial New Animal Drugs With Regard to Their Microbiological Effects on Bacteria of Human Health Concern*, that outlines a quantitative risk assessment framework for the agency to evaluate whether and to what degree a given antimicrobial drug used in food-producing animals could pose a risk to human health through the food supply. The [document](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cvm-gfi-152-evaluating-safety-antimicrobial-new-animal-drugs-regard-their-microbiological-effects?ref=fdaweb.com) also has an appendix ranking antimicrobial drugs by their relative importance to human medicine. FDA says the rankings help inform the risk assessment but are not meant to be a standalone risk management tool.

The agency says the final guidance updates several aspects of a previous draft revised version, including a more detailed description of hazard characterization, combining sections discussing risk management and the application of risk management strategies, clarifying that the appendix importance rankings are not intended to be a standalone guide for risk management decisions, and addressing why FDA excludes topicals in the rankings of medically important antimicrobial drugs.