Is An ASN Really The Best Way to Pass Lot-Based DSCSA Transaction Data?

We are now more than six weeks past the date that the DSCSA originally mandated drug manufacturers, repackagers and wholesale distributors to pass Transaction Information (TI), Transaction History (TH), and Transaction Statements (TS) to their customers in the U.S. and save a copy for six years (see “DSCSA: A Closer Look At The Six-Year Record-Keeping Requirement”).  Of course,

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4 thoughts on “Is An ASN Really The Best Way to Pass Lot-Based DSCSA Transaction Data?”

  1. Dirk,

    Is there still talk of electronic only (e.g. RFID) standardization for unit/lot/case/pallet level tagging. Its been sometime since I’ve studied the regulations closely, but remember that amount of data seeming problematic. Is this still the direction it’s heading?

    Thanks for the time and the learning moment for me.

    1. Matt,
      No. Fans of RFID are disappointed in the lack of interest in RFID in the pharma supply chain (see “The Case Against RFID In Pharma“). The DSCSA contains a Congressional mandate for 2D Datamatrix barcodes on all drugs by 2017. RFID does not comply. However, the Congress gave the FDA the authority to specify other AIDC technologies in the future. You can get a list of other RxTrace essays about RFID here.

      Dirk.

  2. Dirk –
    Thanks for the discussion. What I’ve found from our customers, particularly those that are in both med-device and pharma, is that the ASN is the least path of resistance for passing of this data. We received requirements last year and have since incorporated them into our EDI standard maps that are used by our customers. So far, transactional data is being exchanged and we haven’t heard any issues. I’m assuming that as the market matures with the regulation we will see additional requirements (and solutions) surface. Keep the updates coming! Thanks!

    1. Marsha,
      Thanks for providing us with your company’s real-world experience with exchanging ASNs on behalf of your clients, and I’m glad it seems to be working smoothly. Anytime the entire industry must make some change all at the same time, the adoption can be rough. It is possible that these changes to the ASN might smooth out shortly (or already, as in your experience). In that case, perhaps ASNs will be used to pass DSCSA transaction data right up until 2023 when we know ASNs may not meet the regulatory requirements. That was my original thought, and we should get a better feel for that in the next few months when the May 1 deadline passes. But if things do not settle down soon, then the switch from ASNs to EPCIS may occur sooner than 2023.

      Dirk.

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