Who Is Being Harmed By Four Overdue FDA DSCSA Guidances?

Happy Martin Luther King Day! Congress set the calendar for many different kinds of requirements when it adopted the Drug Supply Chain Security Act, signed by the President back on November 27, 2013.  One of those dates was last November 27, 2015, two years after enactment, when the FDA was required to publish four new draft

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2 thoughts on “Who Is Being Harmed By Four Overdue FDA DSCSA Guidances?”

  1. Hi Dirk- please clarify; for current 3PLs with existing (WDD) licenses/permits, is the intent to continue renewing the WDD licenses when needed until the final guidance forces the states to provide a 3PL license?

    1. Kris,
      The DSCSA appears to provide 3PLs with a blanket license (except for those that the FDA has take specific action against) until the deadline that will be set within the new guidance that is overdue. But that’s just for federal DSCSA purposes. Existing state regulations that require licensing as a wholesale distributor will apparently remain in effect until that same deadline, when the states will also be required to follow the new 3PL licensing guidance. That’s my interpretation but the only interpretations that matter are those of the FDA and the state boards of pharmacy. I am not a lawyer, so to be safe, you might want to check with the states that you operate under to confirm their interpretation.

      Dirk.

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