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FDA to Update Its RFID Vision

At an FDA-organized meeting, drugmakers, pharma distributors and technology providers discussed the challenges ahead in using RFID to make the drug supply chain safer.
By Mary Catherine O'Connor
Florida has passed a bill that goes into effect July 1, requiring all companies selling drugs in the state to provide an electronic pedigree. It does not, however, require the use of RFID or item serialization. California has also passed an e-pedigree bill, not yet in effect, and might include a requirement for item-level serialization via RFID. A number of other states are set to begin requiring e-pedigrees for prescription drugs, as well.

According to pharmaceutical industry representatives attending the meeting, one hurdle facing RFID tagging is a lack of a single frequency standard. Some pharmaceutical companies must comply with Wal-Mart Store's mandate to track shipments of drugs with ultrahigh-frequency tags, but many of these same companies find that UHF tags do not perform as well as high-frequency tags at the item level. As such, Pfizer is using HF tags in its Viagra trial.

Next month, EPCglobal plans to conduct a series of hardware tests, which will include item-tagging scenarios. The performance of HF and UHF hardware systems will be considered against a long list of requirements, such as read range and packaging materials, that manufacturers, distributors and other members of the pharmaceutical supply chain have provided, says Bob Celeste, director of EPCglobal US's Action Groups. "It's not just tags that we'll be testing," he says. "We'll also be looking at things such as antenna placement."

According to Celeste, concerns regarding the use of tags operating at different frequencies are based on the subsequent need for pharmaceutical supply chain trading partners to have multiprotocol interrogators (readers) able to read both HF and UHF tags. This could increase infrastructure costs for companies that have already invested in single-protocol readers, but the frequency used is not important for the creation of an e-pedigree, he says—or the sharing of that data between trading partners.

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