DSCSA 2024 Ten-Count: Number 4 – PDG-FDA-Industry Listening Sessions
Ten Count Consulting reflects on 2024 with our list of top DSCSA moments and stories from 2024.
Number 4:
FDA-Industry Listening Sessions
In September 2024, the Partnership for DSCSA Governance (PDG) facilitated two pivotal listening sessions between the Food and Drug Administration (FDA) and industry stakeholders, focusing on the Drug Supply Chain Security Act (DSCSA) implementation. These sessions provided a platform for dispensers and wholesale distributors to discuss their progress, challenges, and concerns as the November 2024 deadline for enhanced drug distribution security requirements approached.
Key Takeaways from the Listening Sessions
- Progress in System Implementation:
Both dispensers and wholesale distributors reported significant advancements in establishing systems and processes for enhanced drug distribution security under Section 582(g). Many have begun exchanging transaction information at the serialized package level, marking a substantial step toward full DSCSA compliance.
(PDG Final Summary) - Data Consistency and Reliability Issues:
Despite progress, stakeholders highlighted ongoing challenges with data consistency and reliability. The electronic data exchange required for DSCSA compliance has not yet achieved the necessary level of accuracy to prevent potential disruptions in the drug supply chain.
(PDG Final Summary) - Managing the Diversity of WEEs (Waivers, Exceptions, and Exemptions):
Stakeholders expressed concerns about managing numerous overlapping WEEs, especially as the November 27, 2024, deadline approached. Dispensers purchasing from multiple suppliers could face conflicting WEEs that complicate compliance, and implementing system changes to manage these complexities would require significant time and resources.
(PDG Final Summary) - Call for FDA Action:
Participants urged the FDA to consider establishing exemptions to ensure patient access to medications while the industry works to improve data quality and system interoperability. They emphasized that such exemptions should apply broadly across sectors to prevent supply chain disruptions.
(PDG Final Summary) - Concerns About Supply Chain Disruptions:
The Healthcare Distribution Alliance (HDA) expressed concerns that incomplete implementation of the enhanced drug distribution security requirements could lead to significant disruptions in the drug supply chain, potentially exacerbating existing drug shortages and delaying patient care.
(HDA Comments) - Need for Phased Implementation:
The National Association of Chain Drug Stores (NACDS), HDA, American Pharmacists Association(APhA), and the National Community Pharmacists Association (NCPA) had advocated for a phased, stepwise approach to implementing the enhanced drug distribution security requirements previously. - Stakeholder Focus with Regulatory Flexibility:
If granted regulatory flexibility, stakeholders indicated they would prioritize:- Continuous improvement of systems and processes to achieve consistent, reliable exchange of transaction information at the serialized package level.
- Refinement of exception handling processes, including strengthening relationships and ensuring timely resource allocation.
- Increased engagement with direct trading partners to support system improvements, including enhanced use of data “scorecards.”
- Reduction in the volume and complexity of managing transition inventory.
- Scaling up outbound transaction information at the serialized package level.
- Ongoing education of downstream trading partners.
This flexibility would also allow companies to focus on staff training, refining operational processes, and conducting system stress testing to ensure a smooth transition to full DSCSA compliance.
FDA's Response will be covered in an upcoming post.
Conclusion
The September 2024 listening sessions underscored the industry's commitment to DSCSA compliance and the collaborative efforts between the FDA and industry stakeholders. While significant progress has been made, challenges remained and still remain in achieving full data consistency, managing WEE diversity, and ensuring system interoperability.
The List Revealed So Far:
Number 9: FDA 483s Issued for DSCSA Requirements
Number 8: Two-Year Exemption for Small Dispensers
Number 7: DSCSA Stabilization Period Checkpoint PDG-FDA Joint Public Meeting
Number 6: DSCSA Exception Handling: Building Resilient Processes for 2025 and Beyond
Number 5: Counterfeit Drug Threats in the US Supply Chain
Stay tuned to our blog over the coming days as we share the remaining 3 highlights of 2024
Number 3
Number 2
Number 1
