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RFID Solution Announced for California e-Pedigree Reqs
HP, Nosco, SupplyScape, and Systech jointly announced a collaborative solution for meeting pharmaceutical product serialization and electronic pedigree requirements that go into effect in California in 2009. The solution supports RFID and 2D bar code technologies, as well as EPCglobal RFID and electronic pedigree standards.
Oct 12, 2007—This article was originally published by RFID Update.
October 12, 2007—Four companies with extensive experience in pharmaceutical packaging, tracking, and information systems announced a collaborative solution to meet California's impending pharmaceutical product serialization and electronic pedigree (e-pedigree) requirements. The solution supports RFID tags or two-dimensional (2D) bar code labels to provide product identification.
The California law goes into effect January 1, 2009. It requires pharmaceutical manufacturers and wholesalers to include serialized identification on products and to produce e-pedigrees as part of electronic supply chain records. Pharmaceutical manufacturers must originate the pedigrees, and organizations who handle the pharmaceuticals at each stage of the supply chain must update them, David DeJean, director of serialization product sales at Systech International, told RFID Update.
IT provider and integrator Hewlett-Packard (HP), pharmaceutical packaging provider Nosco, packaging technology and software provider Systech International, and e-pedigree software developer SupplyScape now offer an integrated product identification, packaging, and software system to meet California pedigree requirements. Customers can choose the complete solution or individual components, which include product packages developed by Nosco that are pre-encoded with serial numbers, packaging line automation software from Systech, pedigree software from SupplyScape, and integration services from HP. The companies developed the integrated solution after collaborating numerous times on projects for different customers, according to DeJean.
"Approximately 50 percent of the top 30 manufacturers use solutions from two to three of the four companies today, and several use all four," he said.
RFID tags or 2D bar codes can be used to provide serialized product identification. The solution supports the EPCglobal Drug Pedigree Messaging and EPCIS standards (see RFID E-Pedigree's Potential to Improve Pharma and RFID Data Sharing Standard EPCIS is Ratified).
The firms also offer an assessment service to help companies determine what they need to comply, and are conducting a series of compliance workshops this month. More information about the workshops is available on the SupplyScape website.
U.S. national drug pedigree requirements were established in the Prescription Drug Marketing Act (PDMA), but the FDA has delayed enforcing the requirements numerous times, leading states to create their own requirements. Drug pedigree requirements are already in place in Florida and other states. DeJean noted that California's extensive requirements and status as the most populous state will likely have a ripple effect throughout the pedigree movement.
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