HDA’s Kala Shankle is urging wholesale distributors and third-party logistics providers not to wait for Washington before preparing for national licensure requirements.
Shankle’s core message is that the work required ahead of federal rulemaking is already available to companies willing to act now.
The guidance forms part of a wider interview series with Pharmaceutical Commerce, with this instalment serving as the final segment of three.
Auditing existing systems is one of the first concrete steps Shankle recommends for wholesalers and 3PLs looking to get ahead of the coming regulatory standard.
The second step involves engaging directly with HDA to understand precisely where current state rules diverge from what the national licensure framework is expected to require.
Shankle frames this two-step approach as actionable regardless of when the FDA ultimately finalises its national licensure rule.
Preemption remains the biggest open question in the national licensure debate, and Shankle has been one of the clearest voices in the industry unpacking its implications.
The question of how a federal standard will interact with existing state licensing regimes is central to how wholesalers and 3PLs will need to restructure their compliance operations.
Companies that rely on a patchwork of state licences face the most significant operational adjustments as the regulatory landscape shifts toward a unified national model.
Earlier segments of Shankle’s interview covered what national licensure means for wholesalers and 3PLs in practical terms, as well as the current state of readiness across the industry.
The broader message from HDA through Shankle’s commentary is that waiting for regulatory certainty before beginning internal reviews is a strategy that carries real compliance risk.
Firms that begin auditing their systems and engaging with industry bodies now are likely to be better positioned when FDA moves to finalise the rule.