Still No Widescale Mandatory Use of RFID For Drug-Tracking
The FDA is being rather reluctant to force RFID technology on pharmaceutical manufacturers. They do expect certain high-priced, frequently-stolen drugs to be tracked with RFID throughout the supply chain starting Dec 1, 2006. However, their original plan for widescale RFID use by the pharmaceutical industry beginning 2007 has been delayed.
Part of the reason for the change of heart is because RFID is not in as widespread use in the industry as the FDA had hoped. They've been expecting an electronic drug tracking/ pedigreeing solution since the late 1980s. When RFID came along, the FDA assumed the industry would embrace the technology. But due to a variety of technical problems - including the potential of chemically changing liquid drugs with some types of RFID tags - and lack of a single standard, RFID is still in test mode in some parts of the industry.
To help the industry along, the FDA had issued a draft version of their RFID Compliance Policy Guide back in Nov 2004, and has been issuing yearly updates of the Counterfeit Drug Task Force Report (CDTFR). The latest CDTFR update was published in early June 2006, which stated that specific high-priced drugs had to be tracked beginning Dec 1, 2006. Various pharmaceutical industry associations have actually backed this FDA stance on the use of RFID.
The FDA is hoping that widescale use of RFID will follow this Dec 1st requirement, but is not otherwise enforcing the use of RFID in the pharmaceutical industry.
Additional sources: [FDA - Combating Counterfeit Drugs, CPG draft (5 pg PDF), 2006 CPG update 160.900]
Part of the reason for the change of heart is because RFID is not in as widespread use in the industry as the FDA had hoped. They've been expecting an electronic drug tracking/ pedigreeing solution since the late 1980s. When RFID came along, the FDA assumed the industry would embrace the technology. But due to a variety of technical problems - including the potential of chemically changing liquid drugs with some types of RFID tags - and lack of a single standard, RFID is still in test mode in some parts of the industry.
To help the industry along, the FDA had issued a draft version of their RFID Compliance Policy Guide back in Nov 2004, and has been issuing yearly updates of the Counterfeit Drug Task Force Report (CDTFR). The latest CDTFR update was published in early June 2006, which stated that specific high-priced drugs had to be tracked beginning Dec 1, 2006. Various pharmaceutical industry associations have actually backed this FDA stance on the use of RFID.
The FDA is hoping that widescale use of RFID will follow this Dec 1st requirement, but is not otherwise enforcing the use of RFID in the pharmaceutical industry.
Additional sources: [FDA - Combating Counterfeit Drugs, CPG draft (5 pg PDF), 2006 CPG update 160.900]
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