FDA publishes Q&A doc on heparin monograph

The US Food and Drug Administration (FDA) has published a Question & Answer document on its website to help healthcare professionals understand the implications of the change in the US Pharmacopeia's monograph for heparin.

USP updated the monograph to include new tests and reference standards designed to make it less likely that contaminated heparin can enter the supply chain. Around 250 people died last year after heparin intentionally adulterated with over-sulphated chondroitin sulfate (OSCS) entered the supply chain.

The FDA wants to draw doctors' attention to the changes as they will result in approximately a 10 per cent reduction in the potency of the heparin marketed in the USA.

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