FDA Postpones Enforcement of DSCSA Transaction Data Exchange Until May 1

In a direct response to concerns expressed by the Healthcare Distribution Management Association (HDMA) and others (see “HDMA Expresses Concerns About Industry Readiness for DSCSA” and “Will The DSCSA Cause Drug Shortages After January 1?”), the FDA posted new guidance that states their intention to postpone enforcement of just the requirements for manufacturers, wholesale distributors

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3 thoughts on “FDA Postpones Enforcement of DSCSA Transaction Data Exchange Until May 1”

    1. Jeff,
      To my knowledge, the FDA has not spoken or written yet about their interpretation of strength and units, or the questions around Congress’ use of the term “container” and other questions, other than their listing of the questions they “heard” during their May 2014 DSCSA Public Workshop (see http://www.fda.gov/downloads/drugs/newsevents/ucm399693.pdf). With the help of their industry members, GS1 US has built their interpretation of the strength and units issue into their DSCSA guidance document version 1.1 (see “The GS1 Healthcare US Guidance For DSCSA, Vsn 1.1” and search for “strength”).

      As I pointed out last year, we have too many questions right now and too few answers (see “DSCSA: Many Questions, Few Answers“) and that will not change until the FDA provides a lot more information than they have up to now in their meager “guidances” (see “FDA’s DSCSA Guidance in 2014“). Things have been very quite lately. How much longer will we have to wait?

      Dirk.

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