Industry is still looking for a phased, risk-based approach
The quarterly meeting of the California Board of Pharmacy (CBOP)’s Enforcement Committee, which is driving the e-pedigree initiative of the state, was held last week. Although the nominal subjects of the meeting were to discuss the topics of inferencing in reading serial information on product packages, and how to grandfather nonserialized packages still in the supply chain when the state’s rule is scheduled to go into effect (January 1, 2009), the session turning into another bout of CBOP prodding, and industry hedging, on when and how to adopt the program.
Some 300 attendees sat through nearly eight hours of presentations and discussions—indicative of how heightened industry concern is over meeting the looming deadline. As has been the case for the past 12 months (since an earlier schedule had been postponed for two years in September 2006), CBOP officials asserted that they fully intended to hold to the January 2009 deadline. They did, however, make clear that if pharma manufacturers wanted to justify a postponement, they would need to submit detailed requests, in writing, to CBOP (for which there is a template at CBOP’s website, pharmacy.ca.gov). A full CBOP board meeting is scheduled for January 23, which CBOP Enforcement Committee head Stanley Goldenberg called a “watershed” meeting for resolving the lingering doubts about the e-pedigree implementation.
Several manufacturers, including Amgen, Johnson & Johnson and Roche, went on record as supporting 2D barcode technology, which is not only compatible with what European regulators are seeking, but also could meet the serialization requirements of California (with some doubts as to how trading partners will be able to validate individual items). PhRMA presented survey results indicating that at least 16 pharma companies have ongoing serialization pilot programs (the actual number is likely to be significantly higher; PhRMA did not get thorough input from its members). GPhA presented data indicating that compliance would cost generic manufacturers some $500 million. Although there is clearly no consensus, numerous industry and industry-association presentations indicate that case- and pallet-level serialization is feasible now, and would be a good interim step toward full item-level e-pedigree compliance at a later date. Among retailers, Walgreens, Longs and Safeway made presentations.
There were also presentations from Alien Technology (a UHF RFID vendor), Aegate (a barcode-based authentication—as distinct from pedigree—vendor whose system is used in Europe) and Siemens (a manufacturing automation vendor), all basically claiming that the technology for serialization or authentication of trade items is essentially ready to go.
EPCGlobal’s Robert Celeste, director of the association’s Healthcare program, noted that while EPCGlobal has approved a pedigree-messaging standard, and an EPC Information Service (EPCIS) standard, a new workgroup is being formed to address the overlap or interoperability of these two standards. That points not only to the ongoing battle between SupplyScape (a proponent of the pedigree messaging standard) and IBM (favoring the EPCIS standard) that played out in November’s RFID Track and Trace Adoption Summit.
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