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Manufacturers and repackagers have until May 27, 2025 to fulfill the requirements; it's time to prioritize data management.
January 21, 2025
By: Tracy Nasarenko
Vice President of Customer Success, Healthcare, GS1 US
The pharmaceutical industry is at a pivotal moment. The U.S. Food and Drug Administration (FDA) has provided exemptions to qualifying stakeholders which has extended—but not eliminated—compliance deadlines for the Drug Supply Chain Security Act (DSCSA), and stakeholders have extremely limited time to get on board. By May 27, 2025, manufacturers must meet stringent interoperability requirements to ensure seamless data exchange and supply chain coordination, followed by wholesale distributors on August 27, 2025.
Interoperable and accurate data is essential for the efficient delivery of medications—not just to meet regulatory expectations but to ensure patients have timely access to life-saving treatments. Missing DSCSA deadlines could lead to shipment rejections caused by invalid data, worsening drug shortages and straining the supply chain.
While significant progress has been made, recent experience reveals data quality issues to be a critical cause of exceptions. For example, all trading partners need to have corresponding master data when exchanging data in an interoperable manner. Missing or differing identifiers like GS1 Global Trade Item Numbers (GTINs) or Global Location Numbers (GLNs) —which specify products and locations—in one party’s master data can trigger an exception and possibly result in product being quarantined and/or returned, preventing medicines from reaching patients. These challenges underscore the urgent need for improved data management and supply chain collaboration.
Strengthening Data Quality and Connectivity
Achieving DSCSA’s full traceability requirements hinges on the ability to generate and share standardized, high-quality data seamlessly across the supply chain. To address these challenges, stakeholders must prioritize establishing robust data exchange connections with their trading partners. Manufacturers must lead by generating accurate, complete data, and along with distributors and dispensers, ensure its smooth exchange and integration through electronic systems like GS1’s Global Data Synchronization Network (GDSN) and Electronic Product Code Information Services (EPCIS). Even stakeholders granted temporary exemptions due to expected supply chain disruptions or lack of readiness must demonstrate progress in establishing interoperable systems to align with DSCSA requirements.
Cencora’s Pilot Program: A Model for Innovation
Cencora, a leading pharmaceutical distributor, offers a compelling example of how to tackle DSCSA challenges. Partnering with a drug manufacturer and leveraging GDSN for data exchange, Cencora conducted a pilot program to test interoperability readiness. The program demonstrated how real-time data synchronization improves accuracy, minimizes errors, and streamlines operations—key elements for preventing supply chain disruptions.
Automating data processes proved transformative, reducing manual entry and allowing teams to focus on higher-value tasks. At the same time, the program revealed common obstacles, such as resistance to adopting new systems and technical misalignments among trading partners. Through targeted training, collaboration, and iterative testing, Cencora successfully addressed these issues, building trust and paving the way for smoother implementation.
Why GDSN and EPCIS are Essential
To meet upcoming deadlines, stakeholders must adopt systems that enable accurate, interoperable data exchange. GDSN helps ensures that trading partners share standardized product data in real-time, reducing errors and improving supply chain efficiency. EPCIS captures and shares event-level data (e.g., where a product is, when it moved, and why), providing the information needed for end-to-end traceability.
Together, these tools form the backbone of a resilient supply chain. By combining GDSN’s real-time synchronization of product data with EPCIS’s event-level tracking, organizations can ensure seamless communication of product attributes and traceability information.
As more organizations adopt GDSN and integrate EPCIS, the industry will collectively strengthen traceability for pharmaceutical drugs, ensuring uninterrupted patient care and smoother operations.
Preparing for DSCSA
With new deadlines fast approaching, stakeholders must act decisively to avoid disruptions and build a resilient supply chain. Steps to take include:
By proactively addressing these areas, trading partners can navigate the complexities of DSCSA while enhancing operational efficiency and supply chain resilience.
The Path Forward
The DSCSA deadlines present both a challenge and an opportunity for the pharmaceutical industry. Meeting the requirements mitigates the risk of shipment delays and medication shortages while enabling lasting improvements in supply chain efficiency and reliability.
Cencora’s experience demonstrates how strategic investments in technology, data connectivity, and collaboration can turn regulatory requirements into opportunities for innovation. Their pilot program serves as a blueprint for leveraging tools like GDSN and EPCIS to reduce errors, streamline processes, and strengthen interoperability.
As the deadlines approach, industry-wide collaboration will be essential. By sharing best practices, addressing challenges collectively, and embracing forward-looking solutions, the pharmaceutical industry can build a more interconnected and resilient supply chain, ensuring uninterrupted access to critical medications for patients.
For additional insights into Cencora’s pilot program, DSCSA readiness, and the benefits of GDSN and EPCIS, please visit https://www.gs1us.org/industries-and-insights/case-studies/cencora.
Tracy Nasarenko, vice president of Customer Success at GS1 US, leads a collaborative pharmaceutical industry group focused on addressing supply chain challenges and meeting the requirement of the Drug Supply Chain Security Act (DSCSA). Using GS1 Standards, the most widely used supply chain standards in the world, Ms. Nasarenko guides the implementation of these standards to help the pharmaceutical industry deliver safe products to patients.
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