DSCSA compliance is forging ahead, says RxTrace survey

As of May 1, all pharma suppliers (manufacturers) are supposed to be delivering lot-level tracking data to their downstream business partners, and a just-completed survey by Dirk Rodgers, an industry consultant and owner of the RxTrace.com website, shows that nearly 80% of companies responding indicated that they are "likely" to be ready. (The major wholesalers have warned that noncompliant product delivery will be held in quarantine.) At the same time, though, a relatively small number of dispensers who responded to the survey indicate that, by a 60-40 margin, they are not working on a readiness solution; yet 80% of them expect to be ready come July 1 when that sector of the pharma supply chain comes under a DSCSA mandate.

The Drug Supply Chain Security Act (DSCSA) specifies these mandates. After July 1, there will be deadlines for confirming wholesaler and 3PL licensure, and then the beginning of a program to serialize product at the unit level (as opposed to the current lot level) in 2017. The manufacturer responses indicate that 10% are ready now for the 2017 deadline across all their packaging lines; and another 75% are in various stages of partial readiness.

Also worth noting is that roughly three out of five companies are planning to transition to the EPCIS protocol for managing unit-level serial data, from the current use of EDI-based Advanced Shipping Notice (ASN) protocol. EPCIS is the standard established by the GS1 organization; it is not a requirement of DSCSA, but alternatives are hard to come by.

The survey was sponsored by Frequentz (Palo Alto, CA), a provider of IRIS (Information Repository & Intelligence Server) enterprise-level tracking software used in life sciences and other industries. That company has announced a management expansion, with Charles Sweat, founder, taking over as chairman and CEO, and Lew Kontnik, a former Amgen exec who have been involved in pharma traceability for many years, as a strategic advisor.