Category Archives: EPCIS

DSCSA, EPCIS

EPCIS GUIDE for your organization

*NOTE – We are including a Free Trading Partner Integration template for you to download at the end of this article.

The 2023 DSCSA requirement looms in the near future and pharma companies are frantically working together to create and implement the technological goals that create the interoperable system by November 27, 2023. To achieve the three areas of interoperability as defined by the PDSA—exchange, verification, and tracing—these companies must also land on a common informational framework. 

In other words, to create a system that allows for the DSCSA vision of “fully interoperable, electronic tracing of products at the package level,” the industry needs to pick a common standard and use it throughout pharma. I discuss the challenges in my previous article: Drug Supply Chain Security Act, Phase II: Here’s what you MUST know.

Gary Lerner, the president at Gateway Checker Corporation, explained what it would take to make this happen. In short: “Capturing and exchanging information at this level of specificity requires a common information framework.”

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DSCSA, EDDS, EPCIS

Drug Supply Chain Security Act, Phase II: Here’s what you MUST know

As 2020 transitioned to 2021, we took another step closer toward the implementation of 2023 Drug Supply Chain Security Act, Phase II. From manufacturers to wholesalers, pharmacies and other stakeholders, many uncertainties are swirling around the subject, so today we are writing to try to dispel some of the concern.

Let’s start with an overview of DSCSA Phase II and its components.  

DSCSA Phase II, which goes into effect on November 27, 2023, is intended to roll out the electronic tracing of products at the package level.  To make this happen, the 2023 requirements are comprised of three specific parts, and they are as follows:

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EPCIS

EPCIS Explained

At a recent GS1 discussion group meeting one of the moderators acknowledged that they need to create a clear explanation for exactly what EPCIS is.  I’ve never been very impressed with GS1’s ability to explain their own standards at a high-level for non-technical readers.  They do a great job of explaining them at the minutia-level, but that’s the problem.  Non-technical people who must make decisions about GS1 standards probably get bogged down in that minutia and end up not really understanding what it is, why it is significant, and why they should use it.  Too much technical documentation exists on how to apply EPCIS, and not enough documentation on the why.

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EPCIS, GS1 U.S.

The New GS1 US DSCSA Implementation Guidance Suite

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A few weeks ago, GS1 US published version 1.2 of the DSCSA implementation guidance that documents how to apply GS1 standards when meeting the U.S. Drug Supply Chain Security Act (DSCSA).  GS1 US is the GS1 Member Organization (MO) in the United States, of GS1, the global supply chain standards organization.  Companies who market drugs in the U.S. pharma supply chain and their solution providers will find this new version to be an indispensable resource that will Continue reading The New GS1 US DSCSA Implementation Guidance Suite →

EPCIS

InBrief: Pharma Supply Chain Leaders, Stop Throwing Interoperability Under The Bus

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57558052_smallerDuring the report out and follow-up discussion at last week’s FDA Drug Supply Chain Security Act (DSCSA) Pilots Workgroup (see “The 2016 FDA Pilots Workshop”) I heard an example of the industry throwing interoperability under the bus.  That is, setting us all up for major complications down the road that could easily be avoided if the leaders would just address interoperability right today.  One of the long-time leaders of the use of serialization and traceability in the U.S. pharma industry spoke up in front of the entire assembly and said that there existed a general “agreement” within the industry that “not everyone will use EPCIS”.  That is, not everyone will use GS1’s Electronic Product Code Information Services (EPCIS) standard for meeting the DSCSA, and consequently, the FDA and the industry will need to allow other formats of the data in 2023.  I just about fell out of my chair. Continue reading InBrief: Pharma Supply Chain Leaders, Stop Throwing Interoperability Under The Bus →

EPCIS

Will GS1’s EPCIS Be Used Widely For DSCSA Data Exchange?

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????????????????????????????????????????I am confident that GS1’s Electronic Product Code Information Services (EPCIS) standard will take center stage in 2023 when the U.S. Drug Supply Chain Security Act (DSCSA) transitions into what that law calls the “Enhanced Drug Distribution System”, or EDDS.  That’s when the DSCSA mandates that supply chain changes of ownership of prescription drugs must be documented in an interoperable electronic system based on their unique serial numbers.

Each of the steps that must be implemented by the industry between now and Continue reading Will GS1’s EPCIS Be Used Widely For DSCSA Data Exchange? →

EPCIS

Will Use Of EPCIS Force Everyone To Use GS1 Identifiers?

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EPCISOver the last five years the larger companies in the U.S. pharmaceutical supply chain have increasingly aligned around GS1’s Electronic Product Code Information Services (EPCIS) standard for holding and communicating serialization-based events.  The hope and expectation by many of these manufactures and others in the supply chain is that EPCIS will be the standard that ensures supply-chain-wide interoperability in any future track and trace or ePedigree system that the federal government might impose.  On its surface it appears that EPCIS is designed around GS1’s family of serialized identifiers, which are based on GS1’s GS1 Company Prefix (GCP) (see “Anatomy of a GTIN” and “Your GS1 Company Prefix: An Enterprise Resource“).  This includes Continue reading Will Use Of EPCIS Force Everyone To Use GS1 Identifiers? →

EPCIS

The Future of Traceability Repositories and Inventory Management Systems

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Figure 1.

I think there is a significant difference between the traceability repositories we see on the market today and those that I think we are likely to see in the future.  Today, traceability repositories are typically implemented by software suppliers as standalone applications or modules that we end users refer to as “an EPCIS”.  We call it that because the most defining characteristic of these modules is that they implement GS1’s Electronic Product Code Information Services (EPCIS) standard.  Today, traceability repository vendors expect customers to buy their traceability module and integrate it with existing applications.  For a long time now I have felt that this approach was less than optimal and I think we will eventually see a switch occur in the software market toward existing application vendors adding traceability repositories and EPCIS interfaces as new features added to their existing functionality.  Let me explain. Continue reading The Future of Traceability Repositories and Inventory Management Systems →