Jan 16, 2007This article was originally published by RFID Update.
January 16, 2007—Standards organization EPCglobal ratified a new global standard that supports the use of RFID and other technologies for creating electronic pedigrees to securely track the authenticity and chain-of-custody of pharmaceuticals and other items. The new GS1 EPCglobal Electronic Pedigree Document standard can be used to comply with all current U.S. state requirements for pharmaceutical pedigrees and can also be used to provide track-and-trace documentation in other industries.
The standard also meets the U.S. federal pharmaceutical pedigree requirements established in the Food and Drug Administration (FDA) Prescription Drug Marketing Act (PDMA). The national pedigree requirement was to take effect in December 2006, but was blocked by a court order (see Injunction May Slow Momentum for RFID E-Pedigrees).
The standard creates a structure for identifying goods and embedding and updating chain-of-custody information associated with the item. Electronic Product Code (EPC) numbers can be used to uniquely identify the object. EPC numbering is not required, nor is the use of RFID for creating, storing, or communicating pedigree data. Bar code and other methods, including paper documents, can also be used. The standard includes security provisions to indicate if documentation has been tampered. The standard is available for free download from the EPCglobal website.
"Before this standard there was no uniform, industry-recognized way to express pedigrees in electronic form," Lucy Deus told RFID Update. Deus is vice president of product development at SupplyScape, an electronic pedigree solutions provider, and is the EPCglobal Healthcare Life Science and Software Action Group editor for the standard. "The standard will help accomplish two key things: first, it provides a uniform standard and format for compliance with all current pharmaceutical pedigree requirements that can be used by all parts of the supply chain. Second, it provides interoperability, so companies can get their pedigree systems to work with each other."
SupplyScape contributed intellectual property to the standard and says its current products are compliant with the standard. SupplyScape's 45 customers are a mixture of manufacturers, wholesalers, repackagers, and retailers who have used its solutions to create electronic pedigrees for more than 200 million drug bottles. Deus said adoption of electronic pedigree technology has picked up considerably in the past six or seven months as companies had to meet July 2006, compliance deadlines that took effect in Florida and Indiana.
EPCglobal's announcement of the new standard said the organization hopes to release a complete track-and-trace system later this quarter. The larger system would incorporate the new e-pedigree standard and the forthcoming EPC Information Services (EPCIS) standard.
Pharmaceutical diversion and counterfeiting are not considered widespread problems in the U.S., but they are in other parts of the world, and the pharmaceutical industry is acting quickly to put preventive measures in place. There is consensus among pharmaceutical manufacturers, wholesalers, distributors, retailers, and the FDA that RFID can be an effective tool for improving supply chain security. The FDA has promoted use of RFID, and several trial systems and implementations have documented the technology's effectiveness (see Pharmaceutical RFID Pilot Finds Promise, Problems).
Market research reflects this enthusiasm. IDTechEx predicts the use of RFID by the pharmaceutical industry will grow rapidly to become a $2.1 billion market by 2016 (see The Potential for RFID in Pharmaceutical Packaging), and VDC predicts the pharmaceutical industry will lead in item-level tagging (see VDC: Pharma Item-Level RFID to Set Precedent).
