i- The Food and Drug Administration (FDA) has published a draft guidance document titled “Defining Durations of Use for Approved Medically Important Antimicrobial Drugs Fed to Food-Producing Animals.” The guidance document is part of an ongoing effort to promote the judicious use of medically important antimicrobial drugs in animals. It is intended to give animal drug sponsors specific recommendations to revise product use conditions of certain antimicrobial drugs to provide continued effective use in or on animal feed while minimizing antimicrobial resistance.
- The scope of the guidance document includes “all medically important antimicrobial drugs that are approved for use in or on medicated feed” with at least one indication that does not adequately provide a duration of use on current labeling. The information regarding feeding duration on the label should ensure the drug is only used when necessary for the animal’s health and provide veterinarians with flexibility to use the drug in a variety of scenarios. Sponsors should provide both expected and maximum duration of use statements. Affected products are listed on FDA’s website, and the list will be reassessed and updated periodically.
- Compliance with the guidance is voluntary, but FDA will monitor progress for three years. If FDA determines adequate progress has not been made in that time, it will consider whether further action under the Federal Food, Drug, and Cosmetic Act is appropriate. FDA is seeking public comments on the draft guidance document until December 26, 2023.
FDA Addresses Antibiotics in Animal Feed in New Draft Guidance Document
Monday, October 2, 2023
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