DSCSA Serialization Delay Eclipses Grandfathering

Now that the DSCSA is delayed, grandfathering probably won’t exist.  Here’s why.

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3 thoughts on “DSCSA Serialization Delay Eclipses Grandfathering”

  1. More generally:

    I believe that FDA has ignored the obvious “Law of Unintended Consequences” with their recent enforcement discretion one year “delay” Guidance, provided without the long overdue Grandfathering, Exceptions, and Exemptions Guidance.

    FDA thereby has set us all up for a world where long with the “It’s Complicated”,by both the DSCSA Law” and the “Law of Unintended Consequences” …

    The law of unintended consequences, often cited but rarely defined, is that actions of people—and especially of government—always have effects that are unanticipated or unintended. Economists and other social scientists have heeded its power for centuries; for just as long, politicians and popular opinion have largely ignored it.

    May we live in Interesting Times,
    Carl

    1. Carl,
      Good point. The DSCSA is very complex, so I suspect we will see many more unintended consequences before we are all done.
      Dirk.

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