FDA issues final data collection rule for antimicrobial sales

by Erica Shaffer
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WASHINGTON – Companies that produce antimicrobials for use in animals used for food will be required to provide estimates of sales broken down by species, the US Food and Drug Administration announced on May 10. The FDA finalized the rule which revises the agency’s annual reporting requirements for antimicrobial sales.

The final rule also includes a provision that requires the FDA to publish an annual summary report of antimicrobial sales and distribution. The summaries must be published each calendar year by Dec. 31 of the following year.

“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,” Dr. William T. Flynn, DVM, MS, deputy director for science policy in the FDA’s Center for Veterinary Medicine, said in a statement.

The information also will help the agency understand how antimicrobials are sold and distributed for use in animals produced for food.

The data collection requirements are a piece of a National Strategy for Combating Antibiotic-Resistant Bacteria (CARB), which includes the US Dept. of Agriculture which will provide on-farm use of antimicrobials; and the Atlanta-based Centers for Disease Control and prevention which will report antibiotic resistance data. Through the collection of data from multiple sources, CARB aims to provide a comprehensive, science-based perspective on the use of antimicrobial drugs and antibiotic resistance in animal agriculture.

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