2025 PDG-FDA Town Halls Recap: DSCSA Implementation Progress and Key Takeaways

March 26 HDA Partnership for DSCSA Governance (PDG)-FDA virtual town hall meeting.: DSCSA Implementation Progress and Key Takeaways

The PDG-FDA Town Halls have given the industry an insightful look into the current state of DSCSA implementation across the pharmaceutical supply chain and the latest gathering in March continues that insight for us. With the deadline extension for different sectors of business rapidly approaching, the consensus from stakeholders is cautiously optimistic—but not without continued challenges.

Here’s a recap of the most important updates, concerns, and opportunities that emerged during the discussions.

Industry Progress: A Positive Trajectory with Room to Improve

Across the board, participants expressed appreciation for the additional time granted by the FDA’s DSCSA Enforcement Discretion Extension. This breathing room allowed many to improve internal processes, enhance partner collaboration, and elevate the quality of their systems and data.

Connections at the MAH level are nearly complete, and downstream engagement is steadily growing. However, the conversation is now shifting from “Are we connected?” to “Is the data accurate?” and “Do we know how to handle exceptions?”

Data Quality: The New Frontier

While systems are more stable, data quality remains a key concern. Several speakers noted that technical teams have successfully enabled data exchange, but the real challenge lies in understanding and managing the data itself.

Some parties expressed concerns that  Contract Manufacturing Organizations (CMOs) and Third-Party Logistics providers (3PLs) continue to be problem areas in the data chain. There are also still gaps in EPCIS data for returned products and uncertainty around who is responsible for sending and receiving what data. These issues must be addressed to fully meet DSCSA expectations across the supply chain.

Mention of the Lookup Directory and VRS was positive in general, although, about 10–15% of products were not found in the Lookup Directory (LD) during audits, leading to failures in verification. Industry leaders are encouraging all stakeholders to ensure their products are properly listed and that policies are in place for handling data requests— including whether products are, or are not physically in their possession.

Pharmacists & Dispensers: High Dependency, High Stakes

With over 60,000 pharmacies, hospitals, and dispensers expected to comply, many downstream partners are still highly reliant on upstream trading partners for data accuracy and connectivity. The good news? Dispensers are making real progress—but concerns remain around visibility and verification.

Hospitals and healthcare systems, in particular, emphasized the need for assurance from their solution providers that they are connected across all necessary partners. Missing data or incomplete inventories continue to pose compliance risks, especially in complex scenarios like 340B programs, drop shipments, and loaned product workflows.

Key Challenges Highlighted

• Returns without EPCIS Data: 3PLs often receive returned products without the necessary electronic data, creating a compliance gap. LSPedia’s OneScan technology is uniquely equipped to bridge this gap and ensure returns are handled correctly.

• Unclear WDD Requirements for Veterinary Distributors: Stakeholders like VetSource raised important questions around the role of WDDs that supply only to veterinary offices—asking for clearer guidance from regulatory bodies.

• Product Data & Labeling Issues: Barcodes, aggregation errors, and unreadable SKUs continue to be a source of failure. One vendor stated they had approximately 100 SKUs that were cited as unscannable, which could render them unusable in a fully serialized supply chain.

• Lack of DSCSA Expertise: A recurring theme was the need for more personnel who truly understand DSCSA—not just IT systems, but the regulatory and data requirements behind them.

Collaboration & Transparency: Still the Industry’s Greatest Strength

One of the most encouraging themes from the Town Halls was the level of collaboration across the industry. Trading partners are working together more effectively than ever, and the transparency enabled by DSCSA extensions has allowed for more open discussion, training, and shared problem-solving.

Speakers from manufacturers, wholesalers, and dispensers all echoed the sentiment that while perfection is not expected on day one, steady progress, proactive troubleshooting, and a commitment to data quality are essential.

How LSPedia Can Help

Many of the concerns raised—especially around exception handling, returns data, and training—highlight areas where LSPedia is already providing solutions. Through our OneScan platform, we help trading partners:

• Automate exception handling

• Ensure accurate EPCIS data exchange

• Deliver track-and-trace visibility

• Streamline returns processing

• Train teams on DSCSA workflows and compliance best practices

As the industry continues to evolve, LSPedia remains committed to providing the tools, technology, and expertise needed to close the gaps and drive full DSCSA readiness.

Final Thoughts

The March PDG-FDA Town Hall made it clear: the extension has paid off, collaboration is strong, but data quality and exception management are now the frontlines of DSCSA compliance.

Whether you’re an MAH, dispenser, wholesaler, or service provider—now is the time to invest in data clarity, partner accountability, and proven solutions that scale with your business.

Need help navigating what’s next?
Contact LSPedia or schedule a demo to learn how we can help you stay ahead of DSCSA requirements.

Comments for LSPedia Sales Team members to use on for the LinkedIn post:

• The shift from system connections to data quality is real. Exception handling is becoming the new battleground for DSCSA readiness—and LSPedia’s Investigator is ready to help.

• Great recap! The insight on 3PL returns lacking EPCIS data really stood out. This is a gap we’ve solved for thousands of pharmacies but still a lot of work to do for a lot of dispensers.

• Proud to be part of a team that’s tackling DSCSA challenges head-on with tools like OneScan that make a real impact across the supply chain.

• Data is the new priority. It’s not just about being connected—it’s about being connected with confidence.

• The PDG-FDA Town Halls made it clear: collaboration is strong, but we still need to move from system integration to data reliability.

• Returns without EPCIS data? A huge issue—and one LSPedia’s technology is built to address. This is where compliance meets real-world problem-solving.

• Loved seeing how far the industry has come. Now the focus is on exception resolution, labeling quality, and consistent processes—and that’s where LSPedia shines.

• The transparency and collaboration showcased in these town halls are exactly what the industry needs to keep moving forward. Excited for what’s ahead.

• It’s encouraging to hear that dispenser engagement is growing—but they need strong upstream partners and accurate data to succeed.

• Let’s keep pushing for better data, stronger policies, and smarter tools. DSCSA compliance is a journey, and we’re proud to support it every step of the way.

• Hospitals and health systems need assurance that they’re connected—and that their data is clean. That’s a challenge LSPedia is actively solving.

• The PDG-FDA Town Halls emphasized what we see every day—data gaps, exception confusion, and the need for ongoing training. LSPedia is here to fill those gaps.

• When 10–15% of products fail verification due to missing data, it’s a wake-up call. Accurate EPCIS exchange isn't optional—it's critical.

• We’re hearing the same message loud and clear: connectivity is just the beginning. Real compliance depends on quality data and fast exception resolution.

• It’s exciting to see the progress MAHs and dispensers have made—but those still struggling with onboarding and data accuracy should take action now.

• Switching from system-level thinking to data and process improvement is the next big step in DSCSA maturity.

• Lack of DSCSA expertise is a growing concern. That’s why we’ve built training and support into everything we do at LSPedia.

• The message is clear—automation, traceability, and collaboration are no longer “nice to haves” in DSCSA. They’re essential.

• So many challenges mentioned in these town halls—from unreadable barcodes to missing label data—are things our OneScan Suite is already solving.

• Love seeing the emphasis on proactive problem-solving. DSCSA success depends on strong partnerships, reliable tools, and industry-wide accountability.

• This was an excellent recap of where we are and where we need to go. Proud to be part of a team driving real solutions for a complex industry.