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Final Ruling on GFI #263 for Remaining OTC Antibiotics

//Final Ruling on GFI #263 for Remaining OTC Antibiotics

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Final Ruling on GFI #263 for Remaining OTC Antibiotics

The FDA recently issued Guidance for Industry (GFI) #263 which is its final recommendation for the remaining OTC antibiotics used in animal health care.  Issued on June 11, 2021, manufacturers of antibiotics which were listed as medically important in GFI #213 have two years to change remaining formulations from OTC to Rx status.  This change will affect all remaining OTC antibiotic formulations including products marketed by Durvet which contain penicillin, oxytetracycline, and tylosin. 

A complete list of all antibiotics which fall under this guideline can be found on the FDA’s website.

Durvet will continue to develop and market antibiotic alternatives to help fill this void with our dealer customers.

Additional information and background on the GFI's that led up to GFI #263 can be found here.



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Mark Niblo

MARKETING DIRECTOR // Long Distance Runner | Iowa by Birth-Kansas City by Choice



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