Meeting the legal requirements of DSCSA and building genuine operational efficiency are two very different things, according to a senior industry figure.
Gregg Gorniak, vice president of manufacturer operations and data services and secure supply chain lead at Cencora, has drawn a sharp distinction between minimal compliance and meaningful trading partnership.
Gorniak spoke with Pharmaceutical Commerce ahead of his session at HDA’s 2026 Traceability Seminar, titled “Transforming DSCSA Compliance Into Strategic Growth and Innovation.”
He brings experience from both the manufacturer and wholesaler sides of the law, giving him an unusually broad perspective on where companies fall short in practice.
His session explores how trading partners are using AI and enhanced RFID technology to strengthen supply chain visibility across the pharmaceutical sector.
Gorniak argues that compliance investments, when handled strategically, can be turned into genuine operational and commercial opportunities rather than a regulatory burden.
Using drop shipments as a practical example, he walks through how the FDA’s compliance bar for dispensers is access to serialised data, not necessarily an electronic feed.
That legal framework allows manufacturers and wholesalers to satisfy the law simply by posting data to a web portal for download as a PDF or Excel file.
“A portal makes a company compliant,” Gorniak notes, but not necessarily a good partner, and not operationally efficient for downstream partners who still cannot get usable data into their workflows.
Trading partners whose internal processes depend on scanning and ingesting electronic data into their own systems gain little from a static portal, even if it technically satisfies the regulator.
The gap he identifies is between what the law demands and what the broader supply chain actually needs to function at a high level of efficiency.
His broader argument points to a shift already taking shape across the industry, moving away from treating DSCSA data purely as a compliance obligation toward treating it as an operational asset.
Companies that make that transition early are positioning themselves to strengthen relationships with trading partners while also improving their own internal workflows and data quality.
The 2026 Traceability Seminar represents a growing focus within the pharmaceutical distribution sector on extracting lasting value from compliance infrastructure rather than simply checking regulatory boxes.