Which state pharmacy boards have issued formal guidance or advisories specifically addressing compounding of GLP-1/GIP analogs (e.g., tirzepatide) since 2023?
Executive summary
State pharmacy boards and related state regulators issued spot guidance and advisories about compounding GLP‑1/GIP analogs beginning in 2023 and accelerating through 2024–2025 as FDA moved from shortage-era enforcement discretion to deadlines ending compounding. Examples in the record include Alabama (medical board guidance citing improper compounding) and Mississippi (medical board prohibition tied to pharmacy board input); multiple state boards also published compounding guidance or FAQs by 2025 as the FDA set wind‑down dates for 503A/503B compounders [1] [2] [3] [4].
1. State action began in 2023 and targeted both prescribers and compounders
When demand for GLP‑1s surged, state medical and pharmacy regulators started issuing statements in 2023. The Mississippi Board of Medical Licensure in August 2023 expressly prohibited off‑label use of GLP‑1s solely for weight loss based on information it had received from the FDA and the Mississippi Board of Pharmacy [1]. The Alabama Medical Board issued guidance noting some physician offices were improperly compounding semaglutide and warned against use of non‑pharmaceutical‑grade APIs or API not produced by FDA‑registered establishments [1].
2. FDA’s changing national policy forced broad state‑level responses in 2024–2025
The FDA temporarily allowed compounding of semaglutide/tirzepatide while shortages existed, then declared shortages resolved and set enforcement deadlines — a change that triggered state boards to update guidance and FAQs for compounders and prescribers. FDA communications clarified that enforcement discretion for state‑licensed 503A compounding pharmacies ended on specific dates (for semaglutide and tirzepatide at various points in early 2025), and the agency worked with state regulators on inspections and warnings [2] [4] [5].
3. Explicit state board documents are in the public record — Kentucky and others published guidance in 2025
Several states produced written guidance for pharmacists. For example, the Kentucky Board of Pharmacy made a GLP‑1 compounding guidance document available that addresses when compounding semaglutide or tirzepatide is permissible, referencing FDA shortage status and the FD&C Act prohibition on making “essentially copies” of commercially available drugs [6]. The record includes state‑level FAQ and guidance activity across multiple jurisdictions as regulators coordinated with FDA [5] [2].
4. Widespread state action is documented but an exhaustive state list is not present in these sources
Available sources document specific state actions (Alabama, Mississippi, Kentucky) and show widespread state board engagement — FDA presented to state boards and state regulators discussed compounding rules at inter‑governmental meetings [1] [6] [5]. However, the provided search results do not supply a single, comprehensive list of every state board that issued formal advisories since 2023; available sources do not mention a complete roster of states beyond the examples cited [1] [6] [5].
5. Why states acted: safety, counterfeit concerns, and API sourcing
States and FDA raised recurring concerns: compounded GLP‑1 products lacked FDA premarket review, some compounded formulations used semaglutide salts or non‑pharmaceutical‑grade APIs with unknown safety, and reports of adverse events and counterfeit products increased. FDA and state boards warned about temperature‑control failures in shipments and misleading marketing by compounders; these safety rationales underpin state advisories and board actions [2] [7] [8].
6. Two competing perspectives in the record: access vs. safety/regulatory fidelity
Advocates for compounding emphasized access and affordability during shortages when brand supply was limited; compounding allowed lower‑cost alternatives for some patients [9]. Regulators and branded manufacturers countered that compounding “essentially copies” of approved drugs threatens quality and infringes the FD&C Act when shortages end; FDA set deadlines to cease most compounding once manufacturers could meet demand [4] [2].
7. Practical implications for clinicians and pharmacists
Clinicians and pharmacies needed to monitor FDA shortage listings and state board guidance closely: compounding remained permissible only under narrow shortage‑related conditions and required compliant APIs and USP standards; after federal deadlines in 2025, state‑licensed compounders faced clear limits [4] [6] [10]. State board guidance and FAQs were the primary local tools translating federal policy into enforceable practice expectations [6] [11].
Limitations and next steps for verification: this analysis uses only the supplied documents. The sources explicitly name Alabama, Mississippi and Kentucky guidance and describe broad state board engagement and FDA‑state coordination [1] [6] [5]. A comprehensive, up‑to‑date inventory of every state pharmacy board advisory since 2023 is not contained in the provided sources; compiling that list would require direct searches of individual state board websites or a jurisdictional roundup from a regulatory tracker beyond the materials given.