Pharmacy Daily | US track and trace

THE US Food and Drug Authority is urging the US Government to add a clause to the Prescription Drug User Fee Act (which is currently being considered for reauthorisation) with language requiring a more robust, nationwide system to “trackand- trace” individual drug units across the entire supply chain, from manufacturing facilities to pharmacies. If passed, the legislation will fund the FDA for another five years and will give the agency broader enforcement powers, including the ability to inspect the manufacturing facilities of foreign companies, or reject their products if they refuse inspection. Also, the law would give the FDA the right to inspect these foreign companies’ active pharmaceutical ingredients and to block their importation if they fail to meet US standards. The clause to the Act that the FDA is pushing for comes on the back of several instances of counterfeit vials of Roche/Genentech’s cancer drug Avastin being sold to a large number of US medical practices.

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