The Healthcare Distribution Alliance (HDA) held their 2024 Distribution Management Conference (DMC) and Expo in March 2024. The event focused on pharmaceutical supply chain education and drew many manufacturers, distributors, consultants and related third parties. Systech was excited to participate and exhibit at this event to align on best practices and engage in operational and strategic discussions around pharmaceutical distribution.  

As expected, the DSCSA stabilization period and exception handling were hot topics. Here are some key takeaways from the conference:   

• DSCSA Compliance Readiness: The conference emphasized the importance of taking advantage of the des Gesetzes zur Sicherheit der Arzneimittelversorgungskette (DSCSA) an die erweiterte Sicherheit des Arzneimittelvertriebs stabilization period and preparing for compliance with traceability and serialization requirements as the November 27, 2024, enforcement deadline approaches. 
• Exceptions Management: The industry anticipates significant compliance exceptions related to DSCSA 2023’s serialization and traceability requirements. All distributors have teams in place to prepare for these exceptions come enforcement in November. The most common data issues relate to timestamps and missing files. 
• Regulatory Guidance: The FDA provided a  final guidance review with an emphasis on the following:   
  • Anyone subject to DSCSA compliance has 24 hours to respond to a VRS request. 
  • If the product cannot be verified, it needs to be treated as suspect and the investigation workflow must be started.  
  • If the product is determined to be illegitimate, begin the 3911 submission. 

It was wonderful to connect with our customers and partners at this event and  showcase our traceability and exceptions management die Lösungen. Systech is proud to provide a complete track– und– trace solution for everyone in the supply chain ecosystem—manufacturers, contract packagers, distributors, 3PLs, dispensaries and regulatory bodies. Our proven implementation process is configurable, scalable, and built to meet the integration and compliance requirements of today and tomorrow.