Defining Durations of Use for Certain Medically Important Antimicrobial Drugs for Food-Producing Animals

This guidance targets sponsors of approved NADAs and ANADAs for medically important antimicrobial drugs used in the medicated feed of food-producing animals that currently have one or more indications without a defined duration of use. It outlines a voluntary framework to update these products so that all such antimicrobials are used in accordance with principles of judicious use, including establishing clearly defined treatment durations. The objective is to reduce the risk of antimicrobial resistance by aligning animal use of medically important drugs with public health protection efforts, and it provides specific recommendations for sponsors on how to revise approved conditions of use to support this goal.