DSCSA 2024 Ten Count: Number 7-DSCSA Stabilization Period Midway Checkpoint PDG-FDA Joint Public Meeting
As we turn the calendar to 2025 and continue the journey towards DSCSA being fully operational across the supply chain, Ten Count Consulting reflects on 2024 with our DSCSA 2024 Ten Count. Ten Count Consulting's list of top DSCSA moments and stories from 2024.
Number 7:
DSCSA Stabilization Period Checkpoint PDG-FDA Joint Public Meeting
In June 2024, the Partnership for DSCSA Governance (PDG) and the U.S. Food and Drug Administration (FDA) co-hosted a two-day public meeting to assess progress during the Drug Supply Chain Security Act (DSCSA) stabilization period. Approximately 800 stakeholders from various sectors of the drug supply chain participated in person or virtually.
The meeting highlighted significant advancements in establishing technical connections for serialized data exchange, increasing data volume, and improving data quality. However, challenges persist, particularly among less-engaged trading partners across the supply chain. Participants emphasized the importance of developing business processes to manage data imperfections and the necessity for continuous improvement beyond the stabilization period.
Significant Progress, Lingering Challenges
The good news reported was that many stakeholders made strides in establishing the technical connections required for serialized data exchange. Improvements in data volume and quality were key highlights of the meeting. However, these gains aren’t universal. Less-engaged trading partners are struggling to adapt, and disparities in readiness are particularly pronounced among smaller dispensers and organizations with limited resources. As we emphasized in our earlier blog, “Is My Organization Ready for the End of the FDA Stabilization Period?”, the time to assess your DSCSA readiness is now. Gaps in compliance could lead to disruptions in the supply chain if not addressed promptly.
Imperfect Data: A Reality to Manage
One key takeaway from the meeting was the shared understanding that 100% data accuracy is unrealistic and needs to be managed for improvements. With the massive volume of unit-level transactions, errors are inevitable. The emphasis should shift toward developing well-controlled, risk-based processes that manage these imperfections effectively and limit their reoccurrence. This approach aligns with the DSCSA’s broader goals of ensuring safety and security within the pharmaceutical supply chain, even in the face of data inconsistencies.
Collaboration and Education Are Key
As highlighted in the meeting summary published by PDG, "Ultimately, the public meeting highlighted the diversity of preparedness across the supply chain, ranging from trading partners that have prioritized and led DSCSA implementation for years to trading partners just beginning their implementation. Throughout the public meeting, this diversity highlighted the critical difference between preparedness and interoperability. Every company can control their preparedness, and many public meeting participants expressed great confidence in the preparedness of their systems and processes. No individual company, however, can control interoperability; interoperability is a collective capability across the supply chain." A critical theme that emerged was the role of communication and education. Smaller trading partners often face unique challenges, such as limited technical resources or less familiarity with DSCSA requirements. Enhanced collaboration across the supply chain will be essential to bring these partners up to speed and avoid potential bottlenecks.
At Ten Count Consulting, we’ve long championed the idea that no organization can succeed in isolation. Stakeholders must work together to ensure the entire system operates smoothly.
Continuous Improvement Beyond 2024
The DSCSA compliance journey is far from over. Continuous improvement will remain a cornerstone of success. Stakeholders must refine their processes, learn from errors, and adapt to the evolving landscape. The PDG meeting underscored that while significant progress has been made, the road ahead requires vigilance and ongoing effort.
What’s Next?
The time to act is now. Ask yourself:
- Have I tested my readiness through an assessment or effectiveness checks?
- Have I verified the readiness of my trading partners?
- Are my systems capable of managing and exchanging serialized data?
- Do I have processes in place to handle data errors and exceptions?
- Am I making sufficient progress in the transition of DSCSA as a project to operationalization?
- Have I provided adequate training and resources to my team?
If the answer to any of these questions is no, it’s time to address those gaps.
Countdown with Confidence
Ten Count Consulting is here to help you navigate the complexities of DSCSA compliance. Whether you’re a small dispenser seeking guidance or a large organization fine-tuning your processes, we’re ready to support you every step of the way.
Overall, the event underscored the necessity for ongoing efforts to stabilize and improve interoperable systems and processes, ensuring the secure and efficient tracing of prescription drugs in the U.S. supply chain.
The List Revealed So Far:
Number 9: FDA 483s Issued for DSCSA Requirements
Number 8: Two-Year Exemption for Small Dispensers
Stay tuned to our blog over the coming days as we share the remaining 6 highlights of 2024!
Number 6
Number 5
Number 4
Number 3
Number 2
Number 1
