Is The FDA Intentionally Delaying Publication Of The Overdue DSCSA Guidance?

Last week I wrote about the recent FDA DSCSA Public Meeting where the FDA asked for reports on the progress of the industry toward meeting the November 27, 2017 serialization requirements contained in the Drug Supply Chain Security Act (DSCSA) (see “FDA Forfeits Opportunity To Guide Industry”).  In that essay I expressed a view that

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2 thoughts on “Is The FDA Intentionally Delaying Publication Of The Overdue DSCSA Guidance?”

  1. Dirk … Is anyone thinking that the lack of guidance at this late date indicates another delay is coming in the “enforcement”?

    1. Matt,
      That is at least a possible outcome but I don’t recommend counting on anything other than full compliance on time. I suspect it has more to do with the fact that the FDA mandates in the DSCSA were not funded by Congress. That means the FDA needs to pull funds from somewhere else any time it does something to meet their DSCSA timeline. It looks like funding will significantly decrease under the new administration and I wonder what impact that will have on the preparations for 2023.

      Dirk.

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