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EPCglobal Ratifies E-Pedigree Standard

In releasing the standard, the organization seeks to help pharmaceutical companies meet the requirements of U.S. states that have passed drug-pedigree laws.
By Mary Catherine O'Connor
Jan 11, 2007EPCglobal's board of governors has ratified the organization's electronic pedigree standard. The purpose of the new standard is to provide the pharmaceutical industry with a common format that supply chain partners can use to collect pedigree information, upon which providers of pedigree solutions can build their pedigree software offerings. While it addresses only electronic pedigrees (e-pedigrees), as opposed to paper-based ones, the standard does not specify RFID as the only technology that can automatically identify drugs products as they are shipped and received. An e-pedigree system based on the new standard could instead utilize bar coding or some other technology for automated data collection.

The main reason EPCglobal's board ratified the standard was to address the needs of companies involved in the manufacture, distribution and sale of prescription drugs sold in the handful of U.S. states that have passed legislation requiring drug pedigrees.

EPCglobal's Bob Celeste
The states that have enacted pedigree laws (which include Florida, Indiana, Nevada and California) have all done so to deter counterfeit drugs from entering the supply chain. But not all laws require the same types of pedigrees—some allow paper-based pedigrees, while others ask for electronic versions—nor do they provide direction on how data relating to the drug products should be presented so it can be easily shared among trading partners.

"The regulators have not given us the form of the pedigree; they gave data elements and said who and under what conditions [they require them], but they left it to the industry to make the actual pedigree," explains Bob Celeste, who leads EPCglobal's Software Action Group (SAG) and was involved in the development of the standard by EPCglobal's Health and Life Sciences (HLS) Industry Action Group.

"We understand that not all companies are ready to use RFID, but without a standard, it would be much more difficult for the industry to create pedigrees," he says. "We're trying to meet the immediate need for the industry."

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