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Which state pharmacy boards explicitly allow compounding of GLP-1/GIP analogs like tirzepatide and what language do their policies use?
Executive summary
State-level boards generally followed the FDA’s unwind of compounding flexibility: when the FDA declared semaglutide and tirzepatide no longer in shortage it gave 503A pharmacies a limited grace period to stop making “essentially a copy” products (for semaglutide until April 22, 2025; for tirzepatide enforcement discretion ended earlier), and many state notices and board guidance echoed that timeline [1]. Available sources document explicit Ohio guidance saying compounded GLP‑1s that are essentially copies cannot continue and that specific investigational agents (retatrutide, cagrilintide) cannot be used in compounding [2].
1. What the FDA told states — the anchor for state board action
The FDA’s clarifications established firm deadlines for 503A (state‑licensed) compounding: it said compounding, distributing or dispensing semaglutide “essentially a copy” was permitted only within a defined grace period ending April 22, 2025 (or until a court decision) and set an earlier end for tirzepatide-related discretion; those federal timeframes are the baseline most state boards referenced when updating guidance [1].
2. Ohio: explicit prohibition language and specifics
The Ohio Board of Pharmacy published a dedicated guidance document in July 2025 stating that compounded GLP‑1 products that are essentially copies of FDA‑approved drugs cannot continue; it explicitly bars use of retatrutide and cagrilintide in compounding (noting they are not in FDA bulk lists or USP/NF monographs) and references the FDA/court timeline for semaglutide and tirzepatide enforcement discretion [2].
3. Other states and agencies echoed FDA deadlines — examples and tone
State regulatory communications cited in the reporting show consistent reliance on FDA deadlines and a shift from permissive shortage-era posture to enforcement: Washington’s Nursing Commission reposted FDA language about the April 22, 2025 semaglutide timeframe and the end of tirzepatide discretion, and multiple state boards began warning licensees about restrictions and potential inspections [3] [4]. These notices frame the change as returning to “status quo” once shortage designations were removed [5].
4. What policy language tends to look like across guidance
State guidance commonly uses three framing elements: (a) recitation of FDA enforcement discretion dates (e.g., “until April 22, 2025”), (b) a prohibition on compounding products that are “essentially a copy” of an FDA‑approved GLP‑1, and (c) specific prohibitions on compounding investigational or non‑monographed peptides (e.g., retatrutide/cagrilintide), while reminding compounders they remain subject to other statutory quality and safety requirements [1] [2].
5. Enforcement and consequences highlighted by state actions
State regulators and enforcement bodies have acted where compounding occurred outside the rules: Pennsylvania’s Department of State pursued action against a pharmacy that allegedly compounded and distributed thousands of injectable doses in uninspected facilities, demonstrating that boards and state enforcement can and will respond to unauthorized compounding [6]. Industry reporting also warns of increased inspections and PBM audits for 503A pharmacies post‑shortage [7].
6. Legal and practical caveats — litigation and narrow exceptions
Legal disputes have shaped timing and interpretations: FDA’s timelines were influenced by district court rulings and lawsuits from compounder trade groups, and the agency retained the ability to act for safety or quality violations even during periods of leniency. Sources note narrow, proscribed situations where compounding can continue (e.g., individualized allergies or documented medical necessity), but the overall message is that routine production of essentially identical GLP‑1 copies is no longer authorized [1] [8].
7. What’s not fully documented in the provided reporting
A comprehensive, state‑by‑state list of boards that “explicitly allow” compounding of tirzepatide/GLP‑1s with verbatim policy text beyond Ohio is not present in the available sources; many pieces summarize trends or reprint FDA language, but explicit policy language from other individual state boards (beyond Ohio and illustrative reposts like Washington) is not found in current reporting [2] [3].
8. Practical takeaway for pharmacists and prescribers
Practitioners must follow the FDA’s end-of‑shortage timelines reflected in state guidance, treat compounding of “essentially a copy” GLP‑1s as impermissible outside narrow exceptions, avoid using non‑monographed or investigational peptides (e.g., retatrutide/cagrilintide noted by Ohio), and expect inspections/enforcement and liability risks if compounding persists [1] [2] [6].
Limitations: this summary relies solely on the supplied documents; a full catalog of each state board’s current policy language or verbatim statutes was not available in the provided sources (not found in current reporting).