[co-author: Stephanie Kozol]*
What Happened
On November 12, the Kentucky attorney general (AG) issued a formal opinion, concluding that the Kentucky Board of Pharmacy lacks the authority to regulate nonresident pharmacists beyond what is specified in KRS Chapter 315. The board cannot mandate Kentucky licensure for nonresident pharmacists, except for the pharmacist-in-charge per KRS 315.0351(1)(g). Therefore, the board’s proposed amendment to 201 KAR 2:030, which would require all out-of-state pharmacists filling prescriptions for Kentucky residents to be licensed in Kentucky, exceeds the board’s statutory authority.
The Details
On April 15, the Kentucky Board of Pharmacy proposed new rules requiring nonresident pharmacists to obtain a specific license to serve Kentucky citizens.[1] The new rules mandated an active license, a National Association of Boards of Pharmacy Verify credential, and a fingerprint-supported criminal record check, with exemptions from certain exams and education requirements.[2] Additionally, nonresident pharmacies were required to ensure all assisting pharmacists held a Kentucky license and met specific availability requirements for the pharmacist-in-charge.[3] A public hearing was scheduled for June 25, with a June 30, deadline for comments.[4]
In response to a request by Representative Derek Lewis of the Kentucky House of Representatives (who also serves as co-chair to the House’s Administrative Regulation Review Subcommittee), on November 12, the Kentucky AG issued a formal opinion stating the Kentucky Board of Pharmacy has no authority, except as described in KRS Chapter 315, to regulate nonresident pharmacists.[5] In other words, the board cannot mandate Kentucky licensure for nonresident pharmacists, except for pharmacists-in-charge.[6] Therefore, the board’s proposed amendment to 201 KAR 2:030 exceeds the board’s statutory authority.[7] The opinion concluded that the board’s broader claim to regulate all nonresident pharmacists lacks clear legislative authorization and is unsupported by the statutory text or canons of construction.[8]
Why It Matters
The ruling by the AG’s office carries significant implications beyond the immediate determination that the Kentucky Board of Pharmacy lacks the authority to mandate in-state licensing for nonresident pharmacists. This decision establishes a precedent that the board must operate strictly within the boundaries of its legislatively granted powers. Consequently, this reduces the regulatory burden on out-of-state pharmacists and pharmacies, potentially facilitating easier access to medications for Kentucky residents from out-of-state sources.
Interestingly, the proposal by the Kentucky Board of Pharmacy to require all nonresident pharmacists to hold a Kentucky pharmacist license is highly unusual. Currently, only a minority of states (approximately 15-20) mandate that the pharmacist-in-charge of a nonresident pharmacy be licensed in that state. This highlights the exceptional nature of Kentucky’s proposed regulation and underscores the significance of the AG’s ruling in maintaining regulatory consistency.
While the ruling limits the board’s regulatory reach, it also raises questions about how best to ensure the safety and quality of pharmacy services provided to Kentucky residents by nonresident pharmacists. The board and other stakeholders may need to explore alternative mechanisms to achieve these public health goals within the existing legal framework.
Overall, the ruling underscores the necessity for clear legislative mandates when expanding regulatory authority and may influence future legislative and regulatory actions in Kentucky and beyond.
[1] 201 Ky. Admin. Regs. 2:030 (2024), available at https://pharmacy.ky.gov/statutesandregulations/Documents/201%20KAR%202%20030%20file-stamped%20copy.pdf.
[2] Id. at 2.
[3] 201 Ky. Admin. Regs. 2:465, 1-3 (2023), available at https://pharmacy.ky.gov/statutesandregulations/Documents/201%20KAR%202%20465%20File%20Stampd%20Copy.pdf.
[4] 201 Ky. Admin. Regs. 2:050, 8 (2023), available at https://pharmacy.ky.gov/statutesandregulations/Documents/201%20KAR%202%20050%20File%20Stamped%20Copy.pdf.
[5] Ky. Op. Att’y Gen. 24-11 (2024), available at https://www.ag.ky.gov/Resources/Opinions/Opinions/Opinion%20of%20the%20Attorney%20General%2024-11.pdf.
[6] Id. at 4.
[7] Id. at 3-4, 6.
[8] Id. at 6.
*Senior Government Relations Manager
