FDA Task Force Releases RFID RecommendationsBy Renee Boucher Ferguson | Posted 06-09-2006
The report recommends that the FDA remove its "hold" on its so-called pedigree act, reinstating the 2007 deadline for those in the pharmaceutical supply chain to implement some form of electronic tracking technology, be that RFID, bar codes or a combination of both.
While the Task Force didn't actually mandate the use of RFID to track and trace drugs through the pharmaceutical distribution chainfrom manufacturer to wholesaler to retailer to consumerit did point to RFID as "the most promising technology for implementing electronic track and trace in the drug supply chain," and suggested that "stakeholders move quickly to implement this technology."
The concept of utilizing RFID to track drugs stems from the FDA's 1987 Prescription Drug Marketing Act that requires drug distributors to provide a "pedigree" for pharmaceuticalsdocumentation of the chain of custody of drug products.
In 1999 the FDA published its final PDMA regulations, which were to take effect the following year.
After a lot of negative feedbackfrom trade associations and from Congressthe FDA delayed the effective date until 2001.
With little impact on changing practices along the supply chain, in 2004 the FDA again delayed the provisionthis time until December 2006.
The latest deadline was set "because we were informed by stakeholders in the U.S. drug supply chain that industry would adopt electronic track and trace technology by 2007," according to Friday's report.
The thought was that when widely adopted, the new technologyRFIDwould create a sort of de facto e-pedigree standard that would amount to documenting the movement of drugs.
While an industry-wide adoption of RFID by 2007 hasn't actually panned out, during a fact-finding mission in 2006 the Task Force found that what had once been considered an onerous undertakingdeveloping an electronic drug pedigreemight not be that difficult, according to the June 9 report.
However, the Task Force is not pushing the 2007 deadline.
"We continue to believe that RFID is the most promising technology for electronic track and trace across the drug supply chain. However, we recognize that the goals can also be achieved by using other technologies, such as 2D barcodes," the report states.
"Based on what we have recently heard, we are optimistic that the hybrid environment of electronic/paper and the use of RFID/bar code is achievable in the very near future."
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