Pharmacy groups plead with FDA for more time to get on board with track-and-trace

The Drug Supply Chain Security Act, passed by Congress in 2013, lays out a timetable for companies to be able to comply with the so-called track-and-trace rules that would allow the FDA to more easily locate recalled products and to protect against counterfeits. July 1 is the next point on the timeline, when pharmacies are supposed to be able to collect and report data. But some of them are still not ready to comply and trade associations for them are pleading to the FDA for more time. The FDA has been pretty accommodating so far. It gave drugmakers, wholesalers and logistics companies an extra four months to get on board with new regulations requiring them to be able to track lots of prescription drug products all along the chain of custody. The groups argue that with the upstream delay the "implementation timetable has been compressed." They fear if pharmacies don't get a similar break there could be disruptions in the supply chain that would affect patients, leaders of the three organizations wrote. Release | More

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