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U.S. Department of Health and Human Services

Animal & Veterinary

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OSC Reports on Antimicrobial Drugs Sold and Distributed for Food-Producing Animals

by Martine Hartogensis, DVM and Melanie McLean, DVM, Center for Veterinary Medicine, FDA

In December 2010, CVM’s Office of Surveillance & Compliance (OS&C) published a summary of the 2009 sales and distribution data for antimicrobial drugs approved by FDA for use in food-producing animals.

Section 105 of the Animal Drug User Fee Amendments of 2008, called “ADUFA 105,” requires drug sponsors to report to CVM the amount of antimicrobial drugs they sell or distribute each year for use in food-producing animals. The sponsors must include the amount of drugs they sell and distribute both domestically and internationally. OS&C developed a voluntary form drug sponsors may use to report the information. The form, found at http://www.fda.gov/downloads/ AboutFDA/ReportsManualsForms/Forms/UCM219560.pdf, includes fields for all required information.

Under ADUFA 105, CVM must summarize the yearly sales and distribution data received by the center from the drug sponsors. CVM must also make the summary available to the public. To protect confidential business information, CVM does not include sales and distribution data for classes of antimicrobial drugs with fewer than three sponsors. The summary is available on CVM’s website at http://www.fda.gov/downloads/ForIndustry/UserFees/AnimalDrugUserFeeAct ADUFA/UCM231851.pdf.