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USP Rivalry With US FDA Over Compendial Standards Provision Busts Into Open Legislative Fight

 
• By Michael Cipriano

In a letter to Senate HELP Committee chairman Sen. Lamar Alexander and ranking member Sen. Patty Murray, USP and other stakeholders are calling for the removal of language that would exclude biological products from requirements to follow USP quality standards.

Box fighters trainning outdoor . Mixed media
The rivalry between USP and FDA has been renewed.

A little over a year after seemingly settling a conflict over monographs for biological products, the US Food and Drug Administration and the United States Pharmacopeia (USP) appear to be renewing their rivalry in an emerging fight over language in a Senate bill.

USP is specifically taking aim at a provision in draft drug pricing legislation from the Senate Committee on Health, Education, Labor and Pensions that excludes all biologics from requirements to...

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