Animal & Veterinary

FDA Releases Final Rule Related to the Reporting of Antimicrobial Sales and Distribution Information

May 10, 2016

The U.S. Food and Drug Administration (FDA) issued a final rule revising its annual reporting requirements for drug sponsors of all antimicrobials sold or distributed for use in food-producing animals in order to obtain estimates of sales by major food-producing species (cattle, swine, chickens, and turkeys). The additional data will improve our understanding of how antimicrobials are sold or distributed for use in major food-producing species and help further target efforts to ensure judicious use of medically important antimicrobials.

Section 105 of the Animal Drug User Fee Amendments of 2008 (ADUFA 105) requires antimicrobial 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 antimicrobials used in human medicine. Adding the requirement for sponsors to report species-specific sales estimates will complement the data collection plan we are developing to obtain additional on-farm use and resistance data. The collection of data from multiple sources, including enhanced sales data from antimicrobial animal drug sponsors, is needed to provide a comprehensive and science-based picture of antimicrobial drug use and resistance in animal agriculture. Such information will further enhance our 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.

ADUFA 105 also requires that FDA issue annual summary reports of these sales and distribution data collected from sponsors. The law further requires that these data be reported out by antimicrobial drug class. To report summary data in a manner protective of both national security and confidential business information, only those antimicrobial drug classes and other categories with three or more distinct sponsors of approved and actively marketed animal drug products are independently reported. The final rule also includes a provision to improve the timeliness of this annual summary report by requiring that FDA publish the report by December 31 of the following year.

Additional Information

Contact FDA

240-276-9115 FAX
Issued by: FDA, Center for Veterinary Medicine

7500 Standish Place, HFV-1

Rockville, MD 20855

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