No Surprise: DSCSA Verification Delay

Dr. Ilisa Bernstein leaves FDA for APhA It was fairly easy to predict the FDA would invoke enfor

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2 thoughts on “No Surprise: DSCSA Verification Delay”

  1. Thanks for the summary Dirk! Curious if you have any thoughts on FDA leaving the last part active in the guidance “..can associate returned product with the transaction information and transaction statement associated with that product.” This clause seems a bit unclear to me if it is directing capture of the return event with unique identifier or linking to an initial receipt.

    1. Mark,
      This DSCSA requirement will still become effective and enforced on November 27, 2019 and is not a part of the new enforcement discretion. It requires wholesale distributors to only redistribute (resell) returned drugs that they are able to match up with their original outgoing TI and TS. The effective of this is to cut off redistribution of drugs by a wholesale distributor who did not actually handle that specific unit when it was originally shipped to the returnee. Because this requirement does not require communication with the manufacturer, wholesale distributors will be able to deal with it by checking their own database inhouse. Odds are, they will use the same list of incoming SNIs provided by some manufacturers to confirm that they originally received a TI and TS. Interestingly,the VRS will not help wholesalers meet this requirement because a “Yes” response to a VRS verification request does not help them “associate” the returned product with the TI and TS. In those cases, wholesalers may not be able to resell those units unless they originally captured the SNI on the unit when they shipped it originally.

      That’s my take. I have not heard the interpretation that the wholesalers are operating under.


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