FDA meets its Nov. 27 deadline for traceability guidance, while industry readiness is still in question


Agency validates ASN 856, EPCIS interoperability methods for exchanging traceability data

The day before Thanksgiving (which happened to be the one-year anniversary of the passage of the Drug Quality and Security Act, and the date written by law for FDA action), the agency issued draft guidance for how industry should comply with DQSA's interoperable product-tracing information requirements. The relatively brief (eight-page) document validates, to a considerable degree, what industry has already been doing: expanding the data fields of the EDI 856 Advance Shipping Notice data format. FDA also indicated acceptance of "paper or electronic versions of invoices;" "paper versions of packing slips;" the aforementioned EDI 856 and--possibly a first in FDA guidance on this topic--the EPCIS standard being developed by the GS1 organization. Normally, draft guidance is reviewed and commented on for 90 or more days before a "final" guidance is issued--but that would overtake the date, Jan. 1, when the DQSA interoperability rules are supposed to be in force in the industry.

To a considerable degree, industry has been building systems to comply with DQSA already, and the Big Three wholesalers have validated use of EDI 856 with their trading partners. (They have also more or less ordered their manufacturer-suppliers not to depend on paper delivery of this information.) The inclusion of EPCIS is notable because that standard lays some of the groundwork for a next, necessary step in data exchange: how to pass information from the direct manufacturer-wholesaler transaction to other trading partners in a supply chain. About this topic, FDA is rather vague: ""FDA may revisit this application of 'interoperability' as processes and capabilities that promote more standardization become available and as electronic systems evolve and are more widely accessible."

Meanwhile, the scramble is still on for more manufacturers to get their necessary transaction data collected and deliverable in a form acceptable to wholesalers. At the recent HDMA Traceability seminar, an informal estimate of how many manufacturers were ready, with the major wholesalers, was around 60-80%--which leaves a lot of product potentially in a violative state once DQSA becomes effective on Jan. 1. It is highly doubtful, however, that 20% or more of pharma manufacturers will be unable to legally distribute products on Jan. 2; what they, and FDA, will do about the deadline at that time is the next "event" in this long-winding saga.

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