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, just before Christmas, the FDA pushed out that part of the requirement until May 1, 2015 to ensure that the requirement did not induce or exacerbate drug shortages (see “FDA Postpones Enforcement of DSCSA Transaction Data Exchange Until May 1”).
Despite the delay, many companies are already passing the required data to their trading partners through Electronic Data Interchange (EDI) Advance Shipment Notices (ASNs) (see “HDMA Has Updated Their EDI ASN Guidance For DSCSA, Again”). In fact, the vast majority of companies have decided to use ASNs to carry the mandated information rather than GS1’s Electronic Product Code Information Services (EPCIS) (see “Will GS1’s EPCIS Be Used Widely For DSCSA Data Exchange?”).
But are EDI ASNs the right approach to passing DSCSA transaction data? In that last essay listed above I theorized that once companies begin using ASNs to pass lot-based transaction data, they are not likely to switch from ASNs to EPCIS data exchange until sometime in 2021 or even 2022. Since posting that essay I have heard that some companies are finding it more difficult to use ASNs to carry this compliance data than they had originally thought, which leads me to wonder if the switch to EPCIS might happen sooner rather than later.
Many companies are relying on the new DSCSA-specific solutions that they purchased for the purpose of maintaining the required DSCSA transaction data to generate the ASNs that now carry that data. I have heard grumbling about DSCSA solution vendors who “don’t really understand EDI”, which has apparently led to difficulty solving DSCSA and non-DSCSA related problems in the ASNs that those solutions generate. Of course, not all of the vendors fall into this category, but maybe its really just an indication that perhaps EDI is not the best way to pass that kind of information. None of these people want to go on the record with their complaints and even if they would, my intent is not to point any fingers. My point is to wonder if this initial rocky experience with ASNs for some will lead to a quicker move to the use of EPCIS than I originally predicted.
Many pharma manufacturers and wholesale distributors have historically relied on ASNs for more traditional financial purposes, and prior to the use of ASNs for carrying the DSCSA TI, TH and TS, they had a single enterprise EDI solution that generated, received and processed all EDI message types—including ASNs. But now, in some cases, those enterprise EDI solutions are being used to generate all of the EDI message types except the ASNs, which might result in some complex data issues.
I don’t have enough information to be able to know for sure. Perhaps the problems will get ironed out and settle down soon into a smooth operation across the supply chain. But maybe not.
Drop me an email with your experience with your DSCSA transaction data exchange, whether ASNs, EPCIS, web portals or paper, and good or bad. If I get enough of them, I will strip all identifying information from them (including solution provider names) and post them in a future essay. If you have thoughts about the transition from EDI to EPCIS, leave a comment below.
4 thoughts on “Is An ASN Really The Best Way to Pass Lot-Based DSCSA Transaction Data?”
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.
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.
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!
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.
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