But a majority of dispensers (pharmacies) are not yet preparing for their July 1 deadline
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.
LogiPharma Unpacked: Highlights, Key Insights, and the Road to 2025
October 16th 2024In this special post-show episode, we sit down with Ryan Portela, Head of Production for LogiPharma, to reflect on the highlights and key takeaways from this year’s event. From attendee feedback to the most impactful sessions, Ryan shares insider insights and discusses how the momentum from 2024 will continue to shape the future of pharma supply chains. Plus, get a sneak peek into the exciting plans for LogiPharma's 20th Anniversary in 2025.