The pharmaceutical industry stands on the cusp of a transformative milestone as it prepares to meet the serialization requirements outlined by the Drug Supply Chain Security Act (DSCSA). With the previous deadline of November 27 just weeks away, pharmaceutical organizations were deeply entrenched in a complex journey toward compliance. This article delves into the critical strategies and practices that can help ensure a seamless transition to DSCSA compliance while shedding light on the evolving landscape of EPCIS, product master data management and exchange, and how to effectively handle EPCIS exceptions and failures.

The path forward: navigating the complexity of compliance

As the industry grapples with the challenges of DSCSA compliance, a recent critical update has emerged. The FDA, in partnership with the Healthcare Distribution Alliance (HDA), has granted an enforcement discretion, effectively delaying the previous November 27, 2023, deadline by one year, now taking effect in 2024. This important change should be seen as a pivotal moment for the industry. While this enforcement discretion provides temporary relief, it should also serve as a clear warning that further delays are unlikely.

The pharmaceutical sector stands at a turning point, and it is imperative that organizations do not interpret this extension as an opportunity for complacency. Instead, it should fuel the commitment to expedite the compliance journey, recognizing that the extended deadline is a chance to enhance preparedness and solidify strategies. The HDA’s tiered approach to enforcement remains relevant, and the dispensing community’s readiness levels underscore the diversity of the sector.

With all these changes happening, it is of utmost importance that the industry continues to work together to make sure EPCIS (Electronic Product Code Information Services) data transmission goes smoothly. It’s clear that while the timeline has been extended, the industry’s goal to achieve seamless DSCSA compliance should only be strengthened.

Three tiers of readiness: where does your organization stand?

The pharmaceutical supply chain can be divided into three distinct tiers of serialization compliance readiness. First, there are the organizations that are yet to embark on their compliance journey, including brand owners and virtual manufacturers with upcoming drug launches. Second, there are those that have initiated serialization projects but have yet to complete all the requirements. Third, a more advanced segment boasts proven solutions that require integration for EPCIS data transmission. While a minority falls into the category of having completed their DSCSA requirements, this article focuses on strategies that cater to each of these segments.

Foundations for late starters: the urgency of action

For organizations that find themselves in the first category, time is of the essence. Initiating compliance work promptly is paramount. Start by seeking recommendations from trading partners and engaging with solution providers. Book discovery calls and product demonstrations early, recognizing that providers’ availability may be limited. An additional avenue for staying informed is joining the HDA, which offers workgroups and learning sessions to keep up-to-date with DSCSA compliance developments.

Progressing to completion: steady steps towards integration

The second tier, comprising those who have begun but have yet to complete integration with partners, requires careful navigation. Maintain consistent communication with trading partners and solution providers. Ensure a comprehensive plan is executed, including technical meetings, successful testing, and addressing exceptions for EPCIS data exchange. A critical challenge faced by advanced organizations revolves around product master data management, particularly for wholesale distributors managing relationships with multiple manufacturers. The HDA’s recommendations on this front are essential. The industry must move beyond rudimentary methods, such as spreadsheets, and adopt systems that enable seamless sharing and storage of critical data.

Mastering testing and beyond: the final mile to compliance

The third category encompasses those who are well-versed in the process, either due to early initiation or simplified business models. Here, the emphasis lies on rigorous testing before November 27. Assumptions that internal data aligns with partners’ systems can be detrimental. Certainly, ensuring comprehensive testing of EPCIS XML file transmission with both suppliers and downstream customers is a recommendation of utmost importance to adhere to.

Exemplars of success: celebrating seamless compliance

While not a primary focus of this article, organizations that have successfully completed all testing deserve recognition. Their efforts culminate in a headache-free period leading up to the deadline. Their success serves as an inspiration, showcasing the path that others can follow.

Exploring EPCIS: a glimpse into the future of tracing pharmaceuticals

When it comes to meeting DSCSA rules, the Electronic Product Code Information Services (EPCIS) takes center stage. This innovation brings in a new era of clear and precise tracking in the pharmaceutical supply chain. Acting as a digital thread that connects everyone in the supply chain, EPCIS breaks traditional barriers, allowing real-time sharing of important product details. This active network not only makes it easy to track and trace products but also adds a layer of accountability. Whether a product starts in a manufacturer’s facilities or ends up in the hands of a dispenser, EPCIS highlights every step of the journey, ensuring unmatched transparency. Beyond just following rules, EPCIS is a sign of progress, keeping a watchful eye against fake and low-quality products. In a world where authenticity and patient safety matter most, EPCIS becomes a guardian, protecting patients and the pharmaceutical supply chain.

Mastering product master data: key to EPCIS success

One of the most cumbersome challenges faced by the industry is effective product master data management. Wholesale distributors, managing vast arrays of products from various manufacturers, encounter difficulties in maintaining accurate data. The HDA’s guidance underscores the importance of dedicated systems to handle this crucial information. The use of spreadsheets, once commonplace, falls short in the face of today’s complex supply chain demands. An advanced approach involves systems that can adapt to changing product landscapes, accommodating new partners and SKUs seamlessly.

Recognizing the significance of product master data management, key stakeholders are coming together to chart a path toward a more seamless future. The Global Standards One (GS1), a global organization dedicated to standardizing and implementing supply chain processes, has embarked on a transformative initiative to tackle the challenge of managing and storing master data information. While in its early stages, this innovative endeavor, carries profound implications for the pharmaceutical landscape. As the pharmaceutical industry progresses towards full interoperability, one can expect to hear more about the GS1’s initiative towards ensuring seamless master data exchange amongst the pharmaceutical supply chain.

Exception handling: navigating bumps in the EPCIS road

The road to DSCSA compliance isn’t free of obstacles. Exception handling emerges as a crucial component in ensuring data continuity. Instances of EPCIS exceptions and failures can disrupt the flow of information. Therefore, a robust strategy for identifying, addressing, and rectifying these exceptions is essential. Organizations must adopt proactive approaches, such as automated exception detection and well-defined protocols for resolution.

The human element: collaboration and communication

Amidst the technical challenges, the human element remains crucial. Collaboration between trading partners, solution providers, and regulatory bodies is key to a successful transition. Open lines of communication, frequent updates, and shared insights pave the way for a synchronized industry response to DSCSA compliance.

Looking beyond compliance: the future of pharmaceutical traceability

As the industry navigates the final months before the DSCSA deadline, it’s important to recognize that compliance is not an endpoint but a stepping stone toward enhanced traceability and patient safety. Beyond November 27, pharmaceutical organizations can harness the lessons learned and the technology adopted to strengthen supply chain resilience, combat counterfeiting, and bolster patient trust.

Conclusion: embarking on a transformative journey

The journey towards DSCSA compliance is marked by challenges and opportunities. The diverse landscape of readiness necessitates tailored approaches for each organization. From early starters to those completing testing, a commitment to collaboration, innovation, and meticulous planning is the common thread that leads to success. As the industry forges ahead, leveraging EPCIS, mastering product master data, and honing exception handling practices, it paves the way for a future of enhanced pharmaceutical traceability and patient-centric care. 

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Andre Caprio serves as Director of Business Development at Covectra. He can be reached at acaprio@covectra.com.