Published August 28th, 2024

The 2024 HDA – Healthcare Distribution Alliance Traceability Seminar was an amazing opportunity for pharmaceutical industry leaders to discuss DSCSA compliance challenges, and present innovative solutions to help partners remediate these challenges. Below, we discuss some important HDA Traceability Seminar Insights. One of the major takeaways from the conference was the role of Waivers, Exceptions, and Exemptions (WEEs) on DSCSA deployments.

DSCSA Compliance Clock is Ticking

With the deadline for compliance approaching quickly, the compliance clock is ticking, and ticking fast; however, many appear unprepared. Despite reasonable efforts, many pharmaceutical supply chain partners are far from fully compliant, and likely won’t be by the time the stabilization period ends on November 27th.

The FDA has exempted small dispensers (25 or fewer full-time employees for the corporate entity owning the dispenser) from upcoming DSCSA electronic and data-driven requirements; these small dispensers account for about 1/3rd of total dispensers. What remains unclear is whether distributors who ship to these dispensers will also be exempt for those specific transactions.

Furthermore, the FDA cannot guarantee all of those who apply for WEEs will be answered by the end of the stabilization period, and the recommended deadline to submit these requests ended nearly a month ago.

The ambiguity over who is and who isn’t exempt and the indefiniteness of WEE approval could have detrimental implications on pharmaceutical supply chain integrity. Furthermore, handling common exceptions has proven difficult for big wholesalers and other partners, likely to further inhibit pharmaceutical supply chain security.

How Gateway Checker Can Help

The good news? Gateway Checker’s services provide wholesales, distributors, dispensers, and logistics providers the capabilities necessary to handle a variety of common exceptions, including:

• Resending of a file with corrections (even after acceptance)
• Reconciliation of partial shipments/short shipments
• Digital instantiation of products with no corresponding EPCIS data (only to be used in accordance with SOPs)
• Visibility into EPCIS errors

See for yourself how Gateway Checker simplifies DSCSA Compliance. Explore our features for yourself, or contact us to discuss your specific needs.