Last week, Connie Jung, RPh, PhD, Acting Associate Director for Policy and Communications, Office of Drug Security, Integrity, & Recalls, U.S. Food and Drug Administration, spoke about the Drug Supply Chain Security Act (DSCSA) at the GS1 US Connect event in Washington DC. This was our latest opportunity to get a glimpse of what the FDA is thinking and what they are doing. Dr. Jung spoke for about 50 minutes and then answered questions from the audience. Continue reading FDA Speaks At GS1 Connect
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
Ever since the Drug Quality and Security Act (DQSA) was signed into law last November (see “It’s Official, President Obama Signs H.R. 3204, DQSA, Into Law”), more and more people are asking the question, “Does my drug have to follow the DQSA?”. Recently I was on a monthly industry call put on by one of the Big 3 wholesale distributors to discuss the Drug Supply Chain Security Act (DSCSA), which is Title II of the DQSA.
I was surprised how many people asked the wholesaler if their specific product was covered or exempt. Of course, asking a wholesale distributor if your own product must follow a particular Federal law is not likely to get a usable response and that was true in this case, but it did not stop the next person from asking the same kind of question.
In fact, no one can answer that question for you. Even the FDA can’t answer that question for you. I can’t answer that question for you. Only YOU can answer that question based on your knowledge of your product’s characteristics and a careful reading of certain provisions of the DSCSA. I can help you with that part. Continue reading Is Your Drug Exempt From The Federal Drug Supply Chain Security Act?