Kala Shankle, JD

HDA's Kala Shankle unpacks the biggest open question on preemption and offers a two-step playbook for wholesalers and 3PLs preparing for national licensure.

HDA's Kala Shankle says a two-year national licensure runway for distributors could work, but only if states, the FDA and industry move in parallel.

HDA's Kala Shankle explains what a national licensure standard could mean for wholesale distributors and 3PLs, and why its success depends on how much state-level variation remains.

Kala Shankle, JD, HDA’s vice president of regulatory affairs, shares that as DSCSA traceability requirements take full effect, distributors and trading partners are preparing for long-term gains in supply chain security, recall efficiency, and counterfeit prevention.

Kala Shankle, JD, HDA’s vice president of regulatory affairs, describes how FDA officials are signaling a balanced enforcement approach when it comes to DSCSA enforcement, expecting compliance efforts and documentation, but also recognizing that perfection will take time.

Kala Shankle, JD, HDA’s vice president of regulatory affairs, details that after a year of steady progress, manufacturers and distributors report over 97% data accuracy under DSCSA traceability requirements, marking a major milestone in supply chain interoperability and signaling confidence ahead of the November compliance deadline.

Kala Shankle, JD, HDA’s vice president of regulatory affairs, describes how at this year’s seminar, attendees emphasized pragmatic approaches to achieving full compliance while anticipating upcoming FDA rules that could reshape wholesale and 3PL licensure standards across the pharma supply chain.