Since the inception of the Drug Supply Chain Security Act (DSCSA), HELM has enabled our clients to remain compliant with FDA requirements. On August 27, 2025, we reached a major milestone: successfully bringing our wholesale distributor clients live with the most demanding phase yet—serialization compliance at the individual package level.
The Challenge of Serialization
This phase of DSCSA compliance requires organizations to track prescription drugs not only by item, lot, and expiration date, but also by unique serial number on each individual unit. For wholesale distributors, this adds significant complexity to operations, from receiving shipments to fulfilling orders.
HELM’s Approach
HELM’s Serialization Module ensures that compliance does not come at the cost of efficiency. With new capabilities, clients can:
• Ingest EPCIS XML files of serialized data directly from donors and manufacturers.
• Validate shipments at pallet, case, and bottle levels through barcode scanning.
• Maintain aggregation and de-aggregation records as products move from pallets to cases to individual units, preserving compliance through every stage of pick, pack, and ship.
Protecting Clients from Risk
Failure to comply with DSCSA regulations can mean severe penalties, shipment delays, or loss of donor trust. By embedding serialization directly into HELM and its Android scanning applications, we give our clients confidence that every requirement is met—while also strengthening the transparency and safety of their supply chains.
Compliance Today, Prepared for Tomorrow
Serialization compliance marks a significant step forward, but DSCSA continues to evolve. With HELM, clients can be certain that as regulations change, their systems will remain up to date—ensuring humanitarian and nonprofit distributors stay focused on what matters most: delivering safe medicines to those in need.