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FDA to Update Its RFID Vision

At an FDA-organized meeting, drugmakers, pharma distributors and technology providers discussed the challenges ahead in using RFID to make the drug supply chain safer.
By Mary Catherine O'Connor
Through its Healthcare Life Sciences Business Action Group (HLS BAG), EPCglobal has established a pedigree messaging standard working group. This group includes representatives from companies involved in e-pedigree deployments, such as VeriSign and SupplyScape. The goal is to establish standards addressing how electronic pedigrees should be created, maintained and shared, so that all companies required to provide and authenticate the pedigrees may do so using software platforms from different vendors. The group establishing the standards must make them applicable to e-pedigree systems, regardless of whether RFID is utilized.

"Because we will be operating in a mixed environment [with some companies using item-level serialization, facilitated through RFID, and others not serializing or using RFID], we have developed standards that accommodate both approaches," says Celeste. The pedigree messaging standard working group has completed a first draft of the messaging specification standard candidate, and has submitted it to the EPCglobal standardization process. Lucy Deus, a member of the working group and vice president of product development at SupplyScape, says software companies can now start building their e-pedigree platforms around the candidate, which describes how data shall be formatted, authenticated with digital signatures, and shared between supply chain partners. VeriSign and SupplyScape say they have already established the specifications in their platforms.

One issue brought to light during the two-day meeting, says Deus, is that an electronic pedigree does not require item-level serialization—and, therefore, does not require RFID. Some comments and questions she heard during the meeting gave Deus the impression that this decoupling was not initially clear to all attendees. "That's an important distinction," she says, "because if you look purely at e-pedigree, companies are already deploying e-pedigree systems, but without serialization."

Bruce Harder, a VeriSign spokesmen and also a member of the pedigree working group, notes that establishing a standard for data-sharing between e-pedigree platforms is a very important step, part of the groundwork needed before companies can begin sharing item-level RFID data related to pedigrees.

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