Credit: Florida Healthcare Law Firm, Key Vendor
The Kentucky Board of Nursing (BON) has issued sweeping guidance that APRNs must prescribe and administer only FDA-approved GLP-1 medications, such as semaglutide, obtained from licensed pharmacies. Its FAQ page makes clear that compounded alternatives are not considered acceptable substitutes when a commercial product is available.
The Kentucky Board of Pharmacy, however, has left a narrow door open. Its guidance recognizes that compounding may be appropriate where a prescriber documents that the compounded product provides a clinically significant difference for a specific patient, but only under narrow circumstances.
This divergence creates uncertainty for Kentucky providers. One board is effectively drawing a bright-line prohibition, while another is acknowledging the discretion of prescribers in limited scenarios.
The Federal Layer
Under federal law, Section 503A of the Food, Drug, and Cosmetic Act allows compounding under specific circumstances, and when the product is not “essentially a copy” of a commercially available drug. The critical question then becomes what qualifies as a “significant difference” to justify compounding.
FDA itself has admitted the line is not clear in a 2018 guidance:
“It is not possible to offer exhaustive guidance about when a difference will be ‘significant’ to an identified individual patient. At this time, FDA generally does not intend to question prescriber determinations that are documented in a prescription or notation. However, we do intend to consider whether a prescription or notation relied upon by a compounder to establish that a drug is not essentially a copy documents that the determination was made.”
We have also seen pharmacy boards in other states, like Ohio pursue enforcement actions even when providers had patient-specific prescriptions documenting a clinical difference. That kind of state-level overreach makes the landscape particularly risky for Kentucky providers who are prescribing and administering compounded GLP-1s.
Why It Matters
Kentucky providers now face an increasingly regulatory gray zone. The Bard of Nursing has drawn a hard line, the Board of Pharmacy allows narrow exceptions in alignment with the FD&C Act, and FDA continues to monitor compounding activity nationwide. While FDA signals that it will generally defer to prescriber judgment, the requirement for proper documentation creates a compliance pressure point, and state boards have already shown a willingness to take enforcement action even when prescribers and compounding pharmacies believe they have met the standard within their clinical judgement.
For practices that currently administer compounded GLP-1s, or are considering it, the question is no longer just “can we?” but “what are the enforcement risks if we do without clear guidance across the board?”
