Tougher USP Heparin Standard Can’t Beat Beefy Supplier Controls: FDA

While an impending update to the U.S. Pharmacopeia’s (USP) reference standard for heparin sodium will sharpen the drug’s monograph, there is no substitute for solid supplier quality control to prevent contaminants in heparin and other active pharmaceutical ingredients (API), FDA officials say. The revised monograph that USP will propose in November looks strong, but it’s unlikely it will actually help manufacturers and API purchasers detect contaminants in heparin, Ali Al-Hakim, a branch chief at CDER’s Office of New Drug Quality Assessment and USP’s heparin expert, said last month.
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