Kala Shankle on What Comes Next for National Licensure

In the final installment of Pharmaceutical Commerce's interview series with Kala Shankle, VP of Regulatory Affairs at the Healthcare Distribution Alliance (HDA), the conversation turns to two of the most practical questions facing wholesale distributors and 3PLs as FDA works toward a national licensure standard, what's still unresolved, and what companies should be doing about it in the meantime.

Shankle points to preemption as the central open issue. Beyond the question of which requirements become standardized, she flags how preemption will actually operate against the patchwork of existing state rules. Is the federal standard meant to function as a floor, a ceiling, or something in between? And what happens to licenses issued under current state frameworks once a national standard takes effect? Those questions, Shankle says, are ones both companies and states will be working through as implementation approaches.

In the meantime, Shankle lays out a two-part approach for distributors and 3PLs that don't want to wait for a final rule to start preparing. The first is an internal audit, mapping existing systems, SOPs and licensing infrastructure against where a national standard is likely to push quality management and compliance expectations. The second is external engagement, working with industry advocates, particularly HDA, to understand which state-level variations are most likely to create friction with the forthcoming federal framework, and where legislative or regulatory fixes might be needed to close those gaps.

For wholesale distributors and 3PLs, that means the work doesn't wait on Washington. Auditing systems now and pressing HDA on where state rules diverge from the coming standard are the moves available today, regardless of when FDA finalizes the rule.

Watch the first and second segments of Shankle’s interview:

1. What National Licensure Means for Wholesalers and 3PLs
2. Kala Shankle on States, Timing and National Licensure Readiness