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# Antimicrobial Animal Drug Reporting Guidance
- URL: https://www.fdaweb.com/antimicrobial-animal-drug-reporting-guidance/
- Published: 2018-06-28T12:00:00.000Z
- Updated: 2026-09-15T00:16:48.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5141793

FDA has published a guidance, *Antimicrobial Animal Drug Sales and Distribution Reporting Small Entity Compliance Guide*, to help small businesses comply with the agency’s antimicrobial animal drug sales and distribution final rule. The [document](http://www.fda.gov/Downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/UCM612000.pdf?ref=fdaweb.com) uses a question-and-answer format to help antimicrobial animal drug sponsors to annually report to FDA the amount of all antimicrobial drugs they sell and distribute for use in food-producing animals, including those medically important antimicrobials that are used in human and veterinary medicine. The 5/2016 final rule incorporates the annual reporting requirements that were established in the Animal Drug User Fee Amendments of 2008.

“The additional data collected as a result of this rulemaking and supporting guidance … will improve our understanding of how antimicrobial drugs are sold and/or distributed for use in major food-producing species,” FDA [says](https://www.fda.gov/AnimalVeterinary/NewsEvents/CVMUpdates/ucm612041.htm?ref=fdaweb.com).