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FDA RFID Drug Pilot Planned This Summer
The U.S. Food and Drug Administration has signed on to a six-month project with a technology firm, as well as drug companies and hospitals, to study the value of data captured from UHF RFID-tagged injectable drugs as they move from the point of manufacture to a patient.
As the tag is read at the hospital, users could identify if an item has been recalled, whether its expiration data is approaching and whether it is counterfeit; if the tag cannot be read or does not match the product's printed label, it is likely a counterfeit. Kit Check intends to create some "fake" counterfeits to determine whether they can be identified in the supply chain via an RFID tag read. Once the pilot is under way, MacDonald says, the tags are expected to be read at approximately six sites.
The participating hospitals have already been testing or deploying RFID technology for their own purposes, while some pharmaceutical companies may be tagging their products for the first time during this pilot. Drug maker Sandoz, which already utilizes Kit Check's solution, plans to participate in the pilot, using RFID and a central repository to capture and manage data, according to Anthony J. Wallace, Sandoz's head of sales.
"We believe this pilot will show that RFID, a non-line-of-sight technology, can reduce aggregation errors in the supply chain for serialization," Wallace says, as well as "provide efficiency on the product flow in the supply chain and assist hospitals with utilizing DSCSA-required data in recall situations." Sandoz's goal, he adds, is to better understand how its medicines are used at hospitals, optimize the supply chain, and track recalls and expiration dates.
"We expect one of the outcomes [of the FDA pilot] will be giving people a better knowledge of what RFID can accomplish," MacDonald predicts. "What we're hoping is that the pilot shows RFID is a viable and acceptable data carrier." Based on that result, he conjectures, the pilot could open up the Food and Drug Administration to recommending interoperability of RFID with the DSCSA electronic records that are captured and shared among supply chain members and the FDA.
"What we're trying to do is open everyone's eyes about what's already out there," Wallace states. "People think RFID is a 'maybe someday' technology." Far from that, he argues, the technology has been deployed by Kit Check at 500 hospitals to date—with around 100 new hospitals launching the company's RFID solution each year—and RFID tags have been applied to between 65 million and 70 million drugs so far. Most tags are still being applied at the hospital rather than by the pharmaceutical companies. Kit Check finds that compounders are the first drug companies to begin deploying RFID.
The pilot will focus on three audiences, MacDonald says: the FDA, the general public and the pharmaceutical industry. The agency intends to make the final reports public alongside other DSCSA 2023 participants' findings, with the hope that all supply chain stakeholders will benefit from the data.
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