Drugmakers Should Test Heparin Shipments, Audit Suppliers: FDA

The FDA is bolstering the heparin supply chain with a draft guidance telling drugmakers to test each incoming shipment of heparin for species origin and contaminants, and audit each of their heparin manufacturers and handlers.

The draft offers five proposals for keeping the heparin supply chain free of fake active pharmaceutical ingredients (API), including a recommendation that drugmakers test and confirm the species origin of crude heparin in each shipment before use in manufacturing or preparing a product containing heparin.

The guidance comes four years after the agency linked an unusual outbreak of deaths and non-fatal adverse events to combination products containing Chinese-made heparin API that had been contaminated with OSCS. The event prompted the FDA to urge industry to reconsider the importance of using stronger supplier controls.

The OSCS contamination appears to be an example of intentional adulteration. Instead, know exactly what to look for in supplier audits. And the contaminated heparin crisis “could still be happening,” the agency said last year.

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