Antimicrobial Animal Drug Reporting Guidance

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 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.