Par Wants Bulk Vasopressin Compounding Nixed; FDA Agrees

Law360 (August 27, 2018, 10:21 PM EDT) -- Just as Par Pharmaceutical asked a D.C. federal court Monday to enjoin a U.S. Food and Drug Administration policy governing bulk drug compounding, the agency agreed the same day that the policy should not apply to Par's blood pressure drug vasopressin. 

The FDA published a notice in the Federal Register suggesting that vasopressin be taken off the list of drugs that can be compounded by so-called 503B outsourcing facilities. The notice also applies to bumetanide and nicardipine hydrochloride, which are not at issue in this litigation.

"At this time we do not find clinical need for an outsourcing facility to use...

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