FDA finalizes antimicrobial ingredient rule

FDA issued a final rule that requires the sponsor of each approved or conditionally approved new animal drug product containing an antimicrobial active ingredient submit an annual report to the Food and Drug Administration.

The new sales data will improve the agency’s understanding of how antimicrobials are sold and distributed for use in major food-producing species and help further target efforts to ensure judicious use of medically important antimicrobials.

Prior to finalizing this rule, animal drug sponsors were not required to submit sales or distribution data by particular species.