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A broad set of recommended practices for encoding, reading and transmitting serialized product data is finalized, but next steps are already in the works
Even as more and more pharma manufacturers are installing serialization systems on their packaging lines, the industry standards for what to encode, and what to do with the resulting data, have been fuzzy around the edges. The latest GS1 Healthcare US guidance, “Applying GS1 Standards to U.S. Pharmaceutical Supply Chain Business Processes to Support Serialization, Pedigree and Track & Trace,” removes some of that fuzziness, but there will still be new issues to resolve as trading partners grow accustomed to collecting and conveying these data. The document itself has a list of 33 “exceptions” (i.e., anticipated problem areas, for which additional procedures will need to be developed) and notes that “as pilots and implementations continue to inform the content of this guideline, other exceptions may be uncovered and documented in this section in future releases.”
Still, it has been a monumental undertaking to bring manufacturers, packing technology vendors, IT experts and regulatory compliance personnel this far. “This new guideline should be the ‘first stop’ for all organizations that are preparing their pharmaceutical supply chain systems and business processes to meet pending improved supply chain security regulatory requirements,” said Siobhan O’Bara, SVP of industry engagement, GS1 US. There is now a fairly certain consensus on how to encode the NDC, lot number and date of production of a pharmaceutical package, and to define a vocabulary of “events” in the logistics process so that the status of a serialized package can be automatically recorded and reported. Most of these event descriptors come out of GS1’s EPC Information Services (EPCIS) standard. (“EPC” stands for “Electronic Product Code,” which is the parallel GS1 effort to establish business practices for using RFID chips rather than barcodes as product identification. RFID is not excluded from pharma track-and-trace efforts, but most of the industry has settled on use of 2D barcodes rather than RFID tags.)
The guideline alludes to a still-to-be-resolved issue: the discontinuity between EPCIS and the earlier GS1 Drug Pedigree Messaging Standard (DPMS). As the new guideline notes, “DPMS complies with all known U.S. pedigree laws, and is currently the only pedigree format approved by regulators,” while going on to say that “The use of EPCIS events along with specific product and location master data provides a means for trading partners to accumulate the information that would be found in [DPMS].” In other words, an EPCIS system contains all the information necessary to generate a drug pedigree to meet, for example, California’s upcoming e-pedigree rules, but generating an actual pedigree is an additional step.
That issue will undoubtedly be discussed at the next California Board of Pharmacy Enforcement Committee hearing, scheduled for March 14 in Garden Grove, CA. Continuing deliberations on the state’s e-pedigree rules is on the agenda.