What National Licensure Means for Wholesalers and 3PLs

As FDA continues to build out national licensure standards for wholesale distributors and 3PLs, one question looms over the eventual transition: will a federal baseline actually simplify compliance, or just add another layer on top of the state-by-state patchwork companies already navigate? Pharmaceutical Commerce spoke with Kala Shankle, vice president, regulatory affairs at the Healthcare Distribution Alliance (HDA), ahead of her panel at HDA's 2026 Traceability Seminar, "Beyond Traceability: Preparing for National Licensure Standards," which examines the operational, quality and compliance implications of a standardized licensure framework and the evolving role of state boards of pharmacy. In this first installment, Shankle breaks down what the shift from variability to consistency actually means in practice.

She starts by outlining the current burden: distributors and 3PLs must maintain compliance infrastructure capable of tracking renewal cycles, inspections, designated representative requirements, documentation standards and a range of state-specific interpretations of licensing law, all of which differ across jurisdictions. A national standard, she says, has the potential to establish a clearer floor and ceiling for what licensure looks like nationwide, delivering real efficiency gains for companies operating across many states.

But Shankle is careful to note that those gains depend entirely on execution. The central question, she says, is how much variation states will still be permitted to layer on top of a federal baseline. If significant state-level requirements remain in place alongside the new standard, companies may find themselves building additional compliance frameworks rather than replacing existing ones, adding complexity instead of removing it.

Her answer sets up a theme she'll continue to unpack — that the value of national licensure hinges less on the standard itself than on how consistently it's implemented.