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2/18/2004
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FDA Expects RFID Use To Combat Drug Counterfeiting

The agency expects drugmakers and distributors to adopt the technology in stages over the next three years.

The Food and Drug Administration expects pharmaceutical makers and distributors to adopt radio-frequency identification in stages during the next three years to combat drug counterfeiting, according to a report released Wednesday. But the FDA, while promising to assist the widespread adoption of RFID throughout the drug-distribution system, won't mandate any deadlines for its use.

RFID is the most promising track-and-trace technology for providing an accurate pedigree for pharmaceuticals, FDA commissioner Mark McClellan said while introducing the report during a news conference in Washington. "Pedigree" means ensuring that pharmaceuticals are manufactured and distributed under safe and secure conditions, without being tampered with and without counterfeit drugs being introduced into the supply chain.

"Electronic drug pedigrees can be more reliable, authentic, and cost-effective than old-style paper records," McClellan said.

The FDA report predicts that drugmakers and distributors will conduct RFID feasibility studies this year and next will begin using RFID on pallets, cases, and even packages of the pharmaceuticals most likely to be counterfeited. In 2006, most pallets, cases, and packages of drugs most likely to be counterfeited will carry RFID tags, as will pallets and cases of less-valuable drugs. By 2007 all pallets and cases of drugs and most individual packages will be tracked using RFID.

The report also predicts that some pharmaceutical manufacturers, large wholesalers, and some large chain drug stores and hospitals will begin using RFID next year, with all using it by 2007. Smaller retailers will begin using RFID in 2006.

Although the report says drug counterfeiting isn't a widespread problem today, the number of FDA investigations into counterfeiting cases has increased to more than 20 each year from around five annually in the late '90s.

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