FDA’s New DSCSA Grandfathering Guidance

I have now read the FDA’s new draft Grandfathering Policy that was published on Monday (see “FDA

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2 thoughts on “FDA’s New DSCSA Grandfathering Guidance”

  1. I think the guidance was very good on the whole, and I support the FDA’s choice of the packaging date as the key date to be used. On the other hand, there is one disappointing feature–the FDA did not use the same measure of timing for the repackagers. As written, the repackagers must package and sell their unserialized product by 11/2018. So repackagers would have to burn through all their unserialized inventory or add serial numbers by 11/2018, but manufacturers would not. That seems rather uneven and actually reverses the order of who has to be ready first.

    1. BHarold,
      You are exactly right. And that situation will probably result in the FDA issuing another delay in enforcement for repackagers at some point in 2018. Repackagers should submit comments to the FDA’s docket for this new guidance and point out the hardship this will cause them.
      Dirk.

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