The Difference Between Meeting DSCSA and Mastering It

Meeting DSCSA's letter and building genuine operational efficiency are not the same thing, according to Gregg Gorniak, vice president, manufacturer operations and data services and secure supply chain lead at Cencora. Speaking with Pharmaceutical Commerce ahead of his session at HDA's 2026 Traceability Seminar, "Transforming DSCSA Compliance Into Strategic Growth and Innovation," Gorniak draws on experience on both the manufacturer and wholesaler sides of the law to explain the gap between minimal compliance and meaningful partnership. His session explores how trading partners are using AI and enhanced RFID to strengthen visibility and turn compliance investments into strategic opportunities. In the second installment of his interview with PC, he unpacks what separates the two in practice.

Using drop shipments as an example, Gorniak walks through how the FDA's compliance bar for dispensers is access to serialized data, not necessarily an electronic feed, which allows manufacturers and wholesalers to satisfy the law simply by posting data to a web portal for download as a PDF or Excel file. That meets the requirement, he says, but it does little for trading partners whose processes depend on scanning and ingesting electronic data into their own systems. A portal makes a company compliant, Gorniak notes, but not necessarily a good partner, and not operationally efficient for downstream partners who still can't get usable data into their workflows.

Gorniak argues that going beyond compliance means partnering directly with trading partners to understand their processes and investing resources so both sides can operate efficiently, rather than treating data-sharing as a one-way obligation. He also points to an emerging use case for that same serialized data: using AI to identify patterns in EPCIS files, such as recurring issues tied to a specific warehouse, 3PL or shipment type, replacing anecdotal observations with data-backed insight.

Gorniak’s answers point to a broader shift already taking shape across the industry, from treating DSCSA data as a compliance obligation to treating it as an operational asset.