The healthcare supply chain is racing against the clock as the November 27 deadline for full DSCSA compliance rapidly approaches. At the recent Healthcare Distribution Alliance (HDA) Traceability Seminar, industry leaders came together to confront the remaining hurdles, discuss innovative solutions, and address the significant challenges that still stand in the way of package-level serialization and traceability. With the stakes higher than ever, the urgency for action was palpable. A poignant statement from the opening remarks perfectly captured the complexity of the current situation:
As the clock ticks down, achieving full DSCSA compliance is not just a technical challenge but a critical responsibility for the entire supply chain. Below are a few key takeaways our team captured from the seminar.
Waivers and Exemptions: Navigating Compliance Delays
One of the seminar’s central topics was the urgency surrounding Waivers, Exemptions, and Exceptions (WEEs). With the November 27, 2024 deadline looming, supply chain partners are feeling the pressure to ensure compliance – or seek waivers and exemptions where challenges persist.
For companies to file a WEE, it’s essential to demonstrate that significant efforts have been made to meet the requirements while explaining the specific challenges preventing full compliance. The request should detail:
- What DSCSA requirement you need relief from.
- The steps taken so far to meet those requirements.
- Why additional time is necessary.
- How the delay won’t burden downstream trading partners.
- How the supply chain security will be maintained during the exemption period.
The seminar highlighted that filing a WEE is the best way to prevent supply chain disruptions if partners are still facing challenges with data but emphasized that WEEs are not a solution to postpone compliance indefinitely. The goal is to keep the scope of these requests as narrow as possible, focusing on specific areas of non-compliance, which increases the likelihood of swift approval by the FDA. Time is of the essence for filing WEEs, as the agency has been transparent that there will be no further extensions to the stabilization period beyond the November 2024 deadline. Supply chain partners must also communicate effectively to ensure all parties are aware of potential delays, avoiding disruptions and maintaining trust across the network.
Exception Handling: Tackling Errors with EPCIS
Exception handling has become a significant focus as the healthcare industry implements DSCSA serialization requirements. Exceptions occur when discrepancies arise between product shipments and the accompanying traceability data, such as shortages, overages, or missing transaction information. Efficient management of these exceptions is critical to avoid disruptions in the flow of products across the supply chain.
A critical approach to handling these discrepancies involves using EPCIS (Electronic Product Code Information Services), the standard for exchanging serialized product data. However, exception-handling processes must be in place when issues arise—such as incomplete data or mismatched shipment quantities—to resolve these errors quickly. A critical best practice discussed at the seminar is the importance of not resending the entire data file when only part of it contains an error. Instead, companies should issue supplemental data files that address the specific error without disrupting the rest of the data.
Quarantine procedures are another important aspect of exception handling. When shipments arrive without complete or accurate traceability data, the products should be placed in quarantine until the data issue is resolved. This prevents non-compliant products from entering the supply chain while addressing errors without delaying downstream processes. Effective communication between trading partners ensures all parties are aligned and can quickly take corrective actions. The key to exception handling is building robust, proactive systems to manage errors before they create bottlenecks in the supply chain.
Ensuring Compliance with VRS: Streamlining Verification & Saleable Returns
The seminar emphasized the importance of verification processes, particularly through the Verification Router Service (VRS), as a critical component of ensuring DSCSA compliance. VRS is an essential tool for saleable returns, helping distributors and wholesalers verify the legitimacy of returned products before placing them back into the supply chain. This technology allows for near real-time verification by connecting with manufacturers and providing results in sub-second response times. However, some challenges – such as syncing errors and false positives – still exist.
Saleable returns can be verified through two primary methods: direct to source (via VRS or manual verification) and direct to replicate. While VRS has been an industry game-changer, challenges remain, including data availability issues and occasional delays caused by incorrect information formatting. A common error that many industry insiders chuckle about is that failures can occur when information is in all caps and the “caps lock” is turned on at a returns station.
Additionally, credentialing was discussed as a growing trend, offering an extra layer of security in verifying returns and other transactions. The concept of credentialing has surfaced as a way to develop standard messaging protocols that demonstrate that requestors are properly licensed and who they say they are. The Open Credentialing Initiative (OCI) has done some great work in this area: getting industry collaboration and developing open/public standards that anyone can use. Instead of doing manual license checks and developing a “safelist” of email addresses, the providers offering credentialing services (who are following the OCI standards) can be an attractive option for companies that anticipate a lot of verification requests or have a lot of indirect customers. Digital credentials improve trust and response efficiency but have not seen widespread adoption due to either lack of understanding, the number of verifications that have been low during stabilization, costs, or some combination of all these factors.
As the November deadline approaches, manufacturers and distributors are encouraged to adopt VRS to handle the expected influx of verifications when the stabilization period expires this November, as wholesale distributors have to verify saleable returns. Manufacturers should consider adopting credentialing to reduce manual processes and ensure greater trust when conducting verifications.
The Final Push to DSCSA Compliance
With just a few months remaining before the final DSCSA implementation deadline, the HDA Traceability Seminar reinforced the critical importance of collaboration across the healthcare supply chain. Patients are counting on us to get this right, and while the industry has made strides, there is still work to be done. Now is the time for manufacturers, distributors, and dispensers to come together, share best practices, ensure the healthcare supply chain is fully compliant by November 27 and find ways to improve operational efficiency and patient safety.
About the Author
Tatiana Salvano is a Consultant for DSCSA/Serialization Compliance Services at Two Labs. Before joining Two Labs, she held the role of Project Manager at leading serialization solution providers, where she supported manufacturers, distributors, and dispensers in achieving compliance.