Connie T. Jung, RPh, PhD, Acting Associate Director of Policy and Communications, Office of Drug Security, Integrity and Recalls, in the Office of Compliance within the U.S. FDA Center for Drug Evaluation and Research (CDER) delivered an overview of the new Drug Supply Chain Security Act (DSCSA) during a webinar last Monday. The title of the webinar was “FDA Perspectives on Implementation of the Drug Supply Chain Security Act”. The webinar is one of a series that the Healthcare Distribution Management Association (HDMA) plans to offer on related topics through the remainder of the year. If you missed it, don’t worry, they will post the recording and the slides on the HDMA event web page.
I have to give credit to Dr. Jung and the FDA in general for being willing to make presentations like this at this time. The material they cover is a good overview of the new law at a high level. The tough part for the speaker comes at the end when the floor is opened up for Q&A. There were a number of very good questions asked by participants on this one, but most were answered with simple reference to future guidance. Here is Dr. Jung’s answer to Continue reading DSCSA: Many Questions, Few Answers