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FDA finalizes antimicrobial ingredient rule 141244FDA finalizes antimicrobial ingredient rule

Companies must now submit estimates of sales by food-producing species.

May 11, 2016

2 Min Read

FDA issued a final rule today 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.

Related: Education needed on FDA antimicrobial drug regulations

The report must include estimates of sales broken down by major food-producing species (cattle, swine, chickens and turkeys) in addition to the overall estimates companies already submit on the amount of antimicrobial drugs they sell or distribute for use in food-producing animals.


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.

Adding the requirement for sponsors to report species-specific sales estimates will also complement the data collection plan the FDA is developing, as part of the National Strategy for Combating Antibiotic-Resistant Bacteria (CARB), with the U.S. Department of Agriculture and the Centers for Disease Control and Prevention, to obtain additional on-farm use and resistance data.

“This information will further enhance FDA’s ongoing activities related to slowing the development of antimicrobial resistance to help ensure that safe and effective antimicrobial new animal drugs will remain available for use in human and animal medicine,” said Dr. William T. Flynn, D.V.M., M.S., deputy director for science policy in the FDA’s Center for Veterinary Medicine.

The final rule also includes a provision to improve the timeliness of annual reports by requiring the FDA to publish its summary report of the antimicrobial sales and distribution information it collects for each calendar year by Dec. 31 of the following year.

The rule was proposed in May 2015, and takes into consideration hundreds of public comments from the veterinary community, animal feed manufacturing and livestock production associations, drug manufacturers, consumer groups and other stakeholders. Drug sponsors are required to comply with the reporting requirements in the final rule when submitting their reports covering the period of calendar year 2016.

The FDA is responsible for the safety and security of our nation’s food supply, cosmetics, and dietary supplements, for products that give off electronic radiation, and for regulating tobacco products.

Related: FDA to begin testing foods for glyphosate residue

Section 105 of the Animal Drug User Fee Amendments of 2008 requires antimicrobial drug sponsors to annually report to the FDA the amount of all antimicrobial drugs they sell and distribute for use in food-producing animals, including those antibiotics that are not used in human medicine. ADUFA 105 also requires the FDA to prepare summary reports of sales and distribution information received from drug sponsors each year, by antimicrobial class for classes with three or more distinct sponsors, and to provide those summaries to the public.

Source: FDA

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