DSCSA, the 2023 Requirements and EPCIS
Since the enactment of the Drug Supply Chain Security Act in 2013, members of the pharmaceutical supply chain have undertaken efforts to meet each of the major milestones contained within the statute’s 10-year timeline to further secure the safety of the products being distributed. The industry’s progress to 2023 interoperability was top of mind as supply chain and other stakeholders came together at HDA’s recent Traceability Online Seminar.
While HDA was pleased that FDA recently extended its enforcement discretion related to the next major milestone for wholesale distributors — verification of serialized saleable returns — it is important to remember that meeting this part of the DSCSA’s requirements has only been postponed, not eliminated. Further, reaching the ultimate deadline, or “Enhanced Drug Distribution Security,” as it is referred to in the law, will require considerable effort, resources — and based on industry experience to date — lead time. We cannot urge supply chain stakeholders strongly enough to keep moving toward this goal.
The enhanced security provisions effective in 2023 build upon what has been accomplished to date by defining elements for achieving the interoperable, electronic tracing of pharmaceutical products at the package level.
For example, as of November 27, 2018, following FDA’s guidance granting a one-year period of enforcement discretion, product identifiers were required to be affixed to all covered products and homogeneous cases of such products packaged by manufacturers and repackagers. The DSCSA expands upon that requirement by stipulating that as of November 27, 2023, the product identifier must be included as part of the Transaction Information (TI) data for every product transaction.
The requirements effective in 2023 are explicit and complex. So much so that HDA has prepared a detailed explanation of them. This document summarizes the DSCSA’s requirements effective in 2023 with a further explanation of how they apply to the supply chain. We hope that this summary serves as a useful reference point so that trading partners and other stakeholders have additional information and support as they set up compliance operations.
One of the DSCSA’s key 2023 requirements is that the standards for this interoperable exchange of transaction data must comply with a form and format developed by a widely recognized international standards development organization.
Currently, the Electronic Product Code Information Services (EPCIS) — a GS1 standard that enables trading partners to share information about the physical movement and status of products as they make their way through the supply chain — is the only internationally recognized standard that will meet this DSCSA requirement. Though still in the developmental stage for the pharmaceutical and healthcare industries, EPCIS is expected, when fully implemented, to enable seamless, stable, consistent, compatible, electronic connections between trading partners throughout the pharmaceutical supply chain.
To successfully implement EPCIS by November 27, 2023, HDA encourages trading partners, if they have not already done so, to begin to make significant investments (including both capital and staffing) and to have ongoing communication with trading partners and service providers. To help explain why near-term engagement is so important, HDA created a document — “Getting Ready for EPCIS” — to describe the steps the Alliance believes will be involved in evaluating data, establishing connections and other complexities involved in making data exchange by way of EPCIS happen for each company.
Among HDA’s recommendations is that all stakeholders allow sufficient time to develop and meet a range of interim milestones and business requirements. For example, to help enable trading partners to seamlessly meet the DSCSA’s requirements by November 27, 2023, we urge all parties to adopt a goal whereby manufacturers and suppliers begin to send, and wholesale distributors begin to receive, serialized EPCIS event data no later than June 1, 2023.
Above all, we urge recognition that this is a complex, industry-wide undertaking that, to our knowledge, has never been done before within the pharmaceutical industry, certainly not on this scale. Given the complexities of data management, testing, establishing connections and other groundwork as we get ready for the 2023 requirements, we believe that that trading partners can neither start too soon nor be overprepared.
HDA strongly supports the DSCSA’s 2023 requirements, which ultimately will enhance the safety, security and efficiency of the U.S. supply chain. Meeting this milestone will require cooperative efforts by manufacturers, wholesale distributors, service providers and other supply chain members and stakeholders. It will be imperative that they work together to achieve compliance as 2023 rapidly approaches.
For additional DSCSA-related resources, click here. For questions, contact Anita Ducca.