DSCSA: Many Questions, Few Answers

Jung_ConnieConnie 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 a question about the definition of “Container Size”:

“Well, while the law doesn’t specifically specify a new definition for “container size”, we’ll probably provide some more information about that interpretation when we issue guidance on that particular piece, related to transaction information.”

It got to the point where even Perry Fry, the HDMA moderator, commented that he couldn’t wait for this “later date” to arrive because there would be a lot more known at that time.  The point is, the FDA has a lot of work to do between now and then.


It’s no surprise that there are so few answers right now.  The FDA is swimming upstream as they try to learn about the operation of the supply chain and the technology used today and available for tomorrow.  We all have questions for the FDA, but the FDA isn’t going to be able to answer any of them until we answer the questions the FDA has for us.

Their current docket has 13 specific questions that will help them produce a workable draft guidance document before the end of November that establish standards for the industry to follow for the interoperable exchange of information for tracing of human, finished, prescription drugs, in paper or electronic format.  We all want to know what those standards will be, but first things first.  You need to tell the FDA about what you are using today and what exists that might work in the future (see “DQSA: How Should Transaction Data Be Exchanged?”).

The current docket closes on April 21—next Monday—so if you haven’t prepared a response, do it now or let someone else tell the FDA how they think it ought to work.  Let’s just hope that’s how you think it ought to work.

During the HDMA webinar Dr. Jung said that the responses to this docket will help to inform the FDA workshop that is scheduled for May 8 and 9 (see “Is Your Drug Exempt From The Federal Drug Supply Chain Security Act?”).

Not to confuse the situation, but the FDA has opened another docket specifically to collect comments related to that workshop.  It has a similar title and it closes on June 9, 2014, one month after the workshop.  If you miss the first docket, don’t hesitate to submit to the second docket.  The FDA wants to hear from you and this is the mechanism the Federal government gives them to collect your comments.  You can monitor all the workshop activity on the FDA’s workshop event page.  If they run out of space (and they will), they will post a notice on that page.

When will we hear some substantive answers from the FDA about the exchange of transaction data?  The DSCSA gives them until November 27 to publish their draft guidance on that topic (see “The Flaw That Must Be Addressed in H.R. 3204, The Drug Quality and Security Act”).  During the HDMA webinar Q&A, Dr. Jung said,

“…We recognize the sooner we get that information out, the more helpful it will be for stakeholders, so while the law says no later than November 2014, we’re working, and hopefully we’ll be able to provide it in enough time for stakeholders to have to make any changes or modifications to meet it, so, we do recognize that that is something that the stakeholders need to know sooner rather than later.

When I look at the calendar and think about what the FDA needs to do to just meet that November deadline, let alone publish sooner, all I can say is, good luck Dr. Jung.