A Closer Look At Web Portals for DSCSA Transaction Data Exchange

These are the last few days of 2014.  During the rush up to Christmas, the FDA gave the industry a gift by announcing that they will not enforce the transaction data exchange requirements of the Drug Supply Chain Security Act (DSCSA) until May 1, 2015—a four month delay (see “FDA Postpones Enforcement of DSCSA Transaction

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3 thoughts on “A Closer Look At Web Portals for DSCSA Transaction Data Exchange”

  1. Do you think that it would be more appropriate if those web portals provide import/export of respective data in certain standard form such as EPCIS event XML scheme ?

    1. Boris,
      That’s a good question. My current thinking is that companies offering web portals should give their customers the maximum flexibility and choice, including EPCIS events, ASNs and PDF. That is, the customer would be able to configure their account to request one of those formats. However, my suspicion is that most companies using web portals as their only way of passing transaction data will likely choose only a single format. In that case, they should offer HDMA-formatted ASNs if their customers are primarily wholesale distributors, and PDFs if their customers are primarily dispensers.

      In my opinion, most companies are wasting their money investing in EPCIS-based systems for the exchange and storage of transaction data, until around 2022 or so. Of course, I also believe that manufacturers and repackagers should invest in EPCIS-based solutions for management of serialization data in-house.


  2. I wonder who will be reconciling TI/TH with what physically showed up? My guess is most folks are just going to assume the TI/TH data is correct and file it away. For example, imagine the package size listed in TI not matching the package size component on the NDC in the shipment. I wonder what repercussions there would be in an investigation if it turns out the seller’s information was incorrect and you, the buyer, never bothered to check.

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