Pharmacies want more time to comply with track-and-trace rules

This year the FDA 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. Now pharmacy groups are asking if they could catch a similar break. Three pharmacy groups have asked the FDA to postpone the looming July 1 deadline for dispensers to be capable of collecting, retrieving and providing data about the drugs they are receiving. In a letter to the FDA, they said: "Our organizations remain concerned that despite the extensive efforts by pharmacy and wholesale distributor associations to educate dispensers, some trading partners will encounter challenges beyond their control, with the possible outcome of disruptions in the supply chain." 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. Release | More

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