Kala Shankle on States, Timing and National Licensure Readiness

A proposed two-year implementation window may sound like ample runway for wholesale distributors and 3PLs to prepare for a national licensure standard. But according to Kala Shankle, vice president, regulatory affairs at the Healthcare Distribution Alliance, that timeline only works if every stakeholder in the system moves in step. In the second installment of her conversation with Pharmaceutical Commerce, ahead of her panel at HDA's 2026 Traceability Seminar, Shankle explains why readiness is a coordination problem as much as an operational one.

Industry isn't the only variable, she says, and arguably not even the biggest one. Once a final rule is issued, distributors and 3PLs would have two years to comply, and Shankle believes companies can accomplish a great deal in that window if they have clear rule text and clear implementation expectations. But that same clock also has to accommodate states, the FDA and a new framework within the national standard known as Approved Organization status. All of these parties have to move in parallel.

The complication, she notes, is that companies don't control how quickly individual states amend statutes, promulgate regulations, or update their own licensing systems and programs. Some of those changes may require legislative action or formal administrative procedures, meaning state timelines won't necessarily track federal ones.

That mismatch raises what Shankle calls the most important transition question: what happens if the federal effective date arrives and states aren't ready? It's a question HDA is actively grappling with, and Shankle says the two-year runway can be meaningful for industry, but only if everyone with a role in implementation is able to use it.