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FDA Proposes Banning Outsourcers From Bulk Compounding Of Three Drugs

 
• By Joanne S. Eglovitch

FDA’s proposal would, if finalized, protect pharmaceutical manufacturers like Endo, maker of Vasostrict, from competition by outsourcing facilities regulated under Section 503B of the Food, Drug and Cosmetic Act, at least for vasopressin and two other drugs.

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FDA has proposed to remove three bulk drug substances – vasopressin, bumetanide and nicardipine hydrochloride – from the list of bulk drug substances that outsourcing facilities may use in compounding drugs under Section 503B of the Food, Drug and Cosmetic Act. The proposal is a promising sign for commercial drug manufacturers like Endo Pharmaceuticals that would rather not compete directly against outsourcing facilities.

The agency also announced in an Aug. 27 notice other actions it is taking later this year to enforce...

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