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Rules Finalised on US Antibiotic Sales Reporting

11 May 2016

US - The US Food and Drug Administration (FDA) has finalised a rule that revises its annual reporting requirements for drug sponsors of all antimicrobials sold or distributed for use in food-producing animals.

Companies are now required to provide estimates of sales broken down by major food-producing species (cattle, swine, chickens and turkeys) in addition to the overall estimates they already submit on the amount of antimicrobial drugs they sell or distribute for use in food-producing animals.

The FDA said the new sales data will improve understanding of how the drugs are used, and help further target efforts to ensure judicious use of medically important antimicrobials.

Adding the requirement for sponsors to report species-specific sales estimates will also complement the data collection plan the FDA is developing with other agencies, to obtain additional on-farm use and resistance data. The FDA said collection of data from multiple sources, including enhanced sales data from antimicrobial animal drug sponsors, is important for providing a comprehensive and science-based picture of antimicrobial drug use and resistance in animal agriculture.

“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, DVM, MS, 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 31 December 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.

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