The FDA published a new draft guidance yesterday with explanations intended to dispel various kinds of confusion over the five kinds of trading partners defined in the Drug Supply Chain Security Act (DSCSA) text. They are clearly on a roll, with the combination of the recent draft compliance policy, pilot and public meeting announcements, and now this draft guidance exceeding all of the DSCSA-specific communications they produced last year. We’ll know for sure that the logjam has been cleared when we finally see one of the four mandated guidance documents that were originally due on November 27, 2015 (see “Who Is Being Harmed By Four Overdue FDA DSCSA Guidances?“). But what about this new one? Continue reading Identifying Trading Partners Under the DSCSA
The final report of the 2016 RxTrace U.S. Pharma Traceability Survey, sponsored by Frequentz is now available. Download the full free report here. With this year’s survey we attempted to get a glimpse of the progress toward the next deadlines of the Drug Supply Chain Security Act (DSCSA) from drug manufacturers, repackagers, wholesale distributors, 3PLs and dispensers. Each of those different types of respondents were asked a different set of questions that were pertinent to their segment and their regulatory requirements under the DSCSA.