A few weeks ago, GS1 Healthcare US published version 1.1 of their guidance for using the GS1 Electronic Product Code Information Services (EPCIS) standard to meet the U.S. Drug Supply Chain Security Act (DSCSA). See “GS1 Healthcare US Publishes Updated Guidance For DSCSA”. I was too busy at that time to review the document properly, but it is an important addition to the spectrum of information that companies can use to help them understand how to best meet the requirements of the DSCSA so I wanted to get back to it when I had time. That time is now.
As long term readers of RxTrace know, I did not believe EPCIS would ever be usable to meet the now obsolete California Pedigree law (see “The California Pedigree Law Is Now Officially Inoperative”), or any other State pedigree laws, and I do not believe it will be widely used to meet the Federal DSCSA before maybe 2021 or 2022, but I do believe it will take center-stage for meeting the long-term requirements of the DSCSA.
In 2023 the DSCSA transitions into what Congress calls the “Enhanced Drug Distribution Security” (EDDS) phase and despite the lack of details in the DSCSA about how that phase will be implemented, I believe one of several EPCIS-based approachs will be the most likely. More on that in a future RxTrace essay. For my previous essays on the use of EPCIS for meeting various regulations, see:
- “Will GS1’s EPCIS Be Used Widely For DSCSA Data Exchange?”
- “DQSA: How Should Transaction Data Be Exchanged?”
- “DQSA: Getting To Electronic Transaction Data Exchange”
- “Why GS1 EPCIS Alone Won’t Work For California Pedigree, Part 1”
- “Why GS1 EPCIS Alone Won’t Work For California Pedigree, Part 2”
But that doesn’t mean that a few companies with a little extra cash sitting around won’t experiment with exchanging the pre-2023 Transaction Information (TI), Transaction History (TH) and Transaction Statements (TS) with one or more of the big wholesale distributors that also have some of that extra cash, using an EPCIS-based approach in place of Electronic Data Exchange (EDI) (see “HDMA Has Updated Their EDI ASN Guidance For DSCSA, Again”). This is trail-blazing leadership that is not for everyone. The discretionary investments made by these companies will discover the path that everyone else will take in the next decade, assuming there are no surprises in how the FDA interprets the operation of the EDDS.
The 1.1 version of the GS1 Healthcare US guidance document just published provides guidance for using GS1’s EPCIS standard to meet the lot-based data exchange requirements of the DSCSA through November, 2023. That is only recently possible, thanks to the 1.1 version of the GS1 EPCIS standard, ratified last spring and which included lot-based capabilities for the first time (see “GS1 Ratifies Updated Versions of EPCIS and CBV”). Prior to that, EPCIS was only usable with serialized product.
Even if you don’t plan to use EPCIS for data exchange, the updated document is a valuable resource for understanding the technical issues related to the exchange of DSCSA lot-based TI, TH and TS. In that case, you don’t have to read the whole thing, but Chapter 3, “Application to the Drug Supply Chain Security Act (DSCSA)” is well written and a good explanation of DSCSA data exchange. Chapter 5 provides good background to a wide range of technical topics that are pre-requisite to the use of GS1 standards for any kind of data exchange. Part 2: “Identify” covers GS1’s identification standards at a high-level. These include the GS1 Global Trade Item Number (GTIN), Global Location Number (GLN) and Serial Shipping Container Code (SSCC) standards. Part 3: “Capture” covers the encoding of GS1 identifiers, lot and serial numbers within GS1 data carriers (barcodes and RFID tags).
THE BREAKTHROUGH IDEA THAT MAKES EPCIS WORKABLE FOR DSCSA DATA EXCHANGE
Part 4: “EPCIS Principles For This Guideline” is where it starts to get specific about the application of EPCIS for DSCSA data exchange. Part 5: “Application of EPCIS For Lot-Level Management” gets pretty technical with multiple examples in eXtensible Markup Language (XML) to demonstrate exactly what the lot-based data exchange would look like in various supply chain scenarios, but Chapter 18 includes an explanation of the breakthrough idea that makes EPCIS workable for DSCSA compliance.
The breakthrough idea was to segment the “EPCIS Document”, an EPCIS standard-defined XML construct, into multiple sections using its extension mechanism. One section is used to carry the DSCSA Transaction Statement; one is used to carry the master data that is referred by identifiers used to in the EPCIS event contained in the next section; and one is used to carry the traditional EPCIS event(s). This structure solves multiple problems that the designers faced. Before arriving at this design, everyone spent their time trying to cram everything needed to comply with the DSCSA (and the State pedigree laws before it) into that third section. That always seemed wrong, but no one could figure out a better way of doing it. Whoever came up with this newer approach deserves the Nobel Prize for Traceability (if there were such a thing), because it is a very elegant and highly usable application of XML and EPCIS extensibility that exactly fits the industry’s needs.
If the companies in the pharma supply chain ever make use of GS1’s Global Data Synchronization Network (GDSN) for the widespread distribution of product, company and production master data (don’t hold your breath), the master data section could be removed from the DSCSA EPCIS header, thus making it more space efficient.
Part 6: “Application of EPCIS For Serialized Item-Level Traceability” contains more XML examples for exchanging information about serialized product. The innovation included in the lot-based section that makes it work for DSCSA compliance is not present in the examples in Part 6. This section of the document is aimed at the 2023 requirements and we won’t know how the EDDS will work at the technical level until the FDA figures it out and tells us all, so GS1 US can’t really go any further at this time. However, companies who wish to begin including serial numbers in their TI and TH before 2023 will need more than what this document provides. Watch for that to be corrected in the next version of this guidance, probably sometime next year. Until then, Part 6 has only experimental applicability.
This document is targeted at technical people who need to create or operate a solution that interoperates with trading partners using the GS1 EPCIS interface standard for DSCSA pre-2023 compliance. If you don’t fall into that category I still think you will find some of the earlier sections worthwhile. You can download a free copy from the GS1 US website at http://www.gs1us.org/industries/healthcare/gs1-healthcare-us/dscsa/implementation-guide.