DSCSA Exception Handling: A Preview of Your Next Surprise Headache

Companies that participate in the U.S. pharma supply chain and are subject to the U.S. Drug Supply Chain Security Act (DSCSA) are preparing to meet the FDA’s 2015 deadlines for exchanging Transaction Information (TI), Transaction History (TH), and Transaction Statements (TS) for every shipment.  Those preparations include integrating the generation, transmission, confirmation, storage and retrieval (see “DSCSA:

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2 thoughts on “DSCSA Exception Handling: A Preview of Your Next Surprise Headache”

  1. Dirk,
    I work at a Dispenser. Just did another Re-read of the Exception Handling post and decided to reply. You recommend following the HDMA ASN Exceptions Guidelines for the DSCSA when using the HDMA 856 ASN for compliance until the FDA issues its own guidance. I disagree.
    The HDMA guidance significantly differs from what you wrote that compliance would look like in this post “…The seller would need to be able to reopen the ASN, adjust the quantities and perhaps the drugs included in the shipment, depending on the specifics of the original error and the agreed resolution. And then they would need to retransmit the ASN to the buyer, in some cases, keeping the original shipment date and perhaps in other cases, using a new shipment date for the corrected shipment…” This was right on point!

    HMDA acknowledges the need for the seller to provide its customer ‘accurate’ T3 data in “a single document” as outlined in the DSCSA. However, it then condradicts itself by saying there are only two scenario in which the seller would need to provide updated/new T3 to meet FDA requirements, 1)shipment qty greater than ASN; 2) incorrect NDC/Lot# match. Why not in the case of supplier shorts, NDC issues (wrong ndc shipped to what on the ASN),Damaged Product that is either returned or destroyed in place? And how do we void an ASN for a shipment sent to us intended for another end customer? They say in many of these cases the downstream customer has “adequate” T3 if the excess is returned, the mistake is returned or the misshipment is returned then no new T3 is required. But now, we all have inaccurate T3 in our archives.
    I maintain that what you wrote (copied above) is correct but not when you recommend us to follow the HDMA guidelines. What the HDMA is providing as guidance to their member community will NOT keep them in compliance with the FDA on the DSCSA.
    In the end, a dispenser – or any downstream recepient from a MFG – needs to have Accurate T3 for what was transacted/received and to have it in a single document in order to be able to respond to an inquiry from the FDA.
    If their systems can’t do that, then they have some internal work to do as long as they indend to utilize the HDMA 856 ASN as their vehicle to compliance with the DSCSA.

    1. Randy,
      Thanks for your reply and your compliments. You are exactly right that my opinions rarely line up with the HDMA exactly. In fact, the same could be said about my opinions and GS1, GS1 US, the FDA, my former employers and just about everybody else. That’s the fun of being a blogger, isn’t it!?

      But I stand by both my original description of how I think it should work (the part you agree with) and my recommendation that companies follow the HDMA guidance until the FDA provides their own guidance (the part you disagree with). The reason is that interoperability necessitates a common approach in these instances (see “Interoperability And The DSCSA“). In this case, HDMA is offering a consensus opinion of how exception handling should work–albeit, a consensus mostly of wholesale distributors–and, more than likely, many companies will follow it. That provides “cover” until the FDA provides more specific guidance.

      It is not surprising that the HDMA guidance offers a minimalist approach to exception handling. We see the same thing in their recommendation for an abbrieviated Transaction Statement (see “HDMA Has Updated Their EDI ASN Guidance For DSCSA, Again“. If the FDA eventually accepts this shortened version, great. It is not hard to incorporate it into existing EDI and EPCIS implementations. If they later say the HDMA version is insufficient, OK, then you can switch to whatever the (probably less convenient) FDA version is at that time. In the absence of particular FDA guidance, it is probably safe to assume the simple case rather than the complex case.

      The complexity (read, $$$$) of exception handling can quickly get out of hand if you always assume the complex case. The HDMA has proposed the simple case. If the FDA later instructs the industry that this is considered “non-compliant”, then make the necessary changes at that time along with everyone else. On the other hand, if you do not think you can remain in compliance without additional documentation, then inform your supplier that you will require additional/corrected documentation in every situation, or you will return the entire shipment. If you are a very large dispenser, chances are your wholesale distributor(s) will figure out a way to provide you with what you want. If you are a small chain pharmacy or an independent, you might not have much recourse but to accept what your supplier gives you. If the FDA later balks, maybe you can then bring your supplier(s) into the discussion with them at that time.

      Dirk.

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