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Which specific U.S. compounding pharmacies have state licenses and policies permitting compounding of tirzepatide (e.g., semaglutide/GLP-1/GIP analogs)?
Executive summary
State-licensed U.S. compounding pharmacies generally lost the regulatory window that allowed routine compounding of tirzepatide once the FDA declared the shortage resolved: the FDA gave 503A (state‑licensed) pharmacies a 60‑day enforcement‑discretion window that ended February 18, 2025, and 503B outsourcing facilities a 90‑day window that ended March 19, 2025 [1] [2]. Available sources do not list a current roster of specific state‑licensed compounding pharmacies that lawfully continue to compound tirzepatide after those dates; instead, they emphasize rules, transition deadlines, and that only patient‑specific or clinically‑different formulations may remain lawful [3] [4].
1. FDA deadlines changed who can legally compound tirzepatide
After declaring the tirzepatide shortage resolved, FDA issued time‑limited enforcement discretion: state‑licensed (503A) pharmacies had until February 18, 2025, and 503B outsourcing facilities until March 19, 2025, to wind down production of essentially identical copies of approved tirzepatide products [1] [2]. Multiple legal and industry writeups echo that those transition periods ended and that routine mass compounding of “essentially a copy” is no longer protected by FDA discretion [5] [4].
2. Where reporting focuses: rules and timelines, not a state‑by‑state list
Most articles and legal analyses focus on the regulatory framework and enforcement timelines rather than publishing a vetted list of compounding pharmacies that hold state licences and explicitly permit tirzepatide compounding after the deadlines. For example, law firms, trade groups and public health sites summarize the FDA’s order, enforcement grace periods, and the legal pushback from compounders and manufacturers [2] [6] [7]. Available sources do not provide a contemporaneous directory of specific state‑licensed pharmacies still compounding tirzepatide after the enforcement discretion ended.
3. Some compounders advertised tirzepatide during the shortage — but that changed
Before the FDA resolved the shortage, compounding pharmacies such as Empower Pharmacy openly marketed tirzepatide/niacinamide formulations and identified themselves as a 503A compounding pharmacy offering patient‑specific tirzepatide products [8] [9]. However, multiple outlets note that once the shortage was declared over, these operations faced limits and were expected to stop producing standard copies unless they could demonstrate a documented clinical difference [3] [2].
4. Legal and industry friction means public lists are unreliable
Eli Lilly and other brand manufacturers pursued legal action and cease‑and‑desist efforts against compounders; compounders also sought injunctions — many of which were denied — complicating the legal landscape [6] [5]. Trade associations and pharmacy groups reported disappointment and urged different policy choices, reflecting competing agendas: manufacturers seek to protect supply and IP, while compounders argue patient access and affordability [10] [6].
5. Permissible narrow pathways: patient‑specific or clinically‑different compounds
Sources indicate that even after the end of broad enforcement discretion, 503A pharmacies may still produce a compounded product for an individual patient pursuant to a valid prescription if the compounded item is not “essentially a copy” or it provides a documented clinical difference from the approved product; large‑scale or routine copies are barred [3] [4] [2]. This distinction matters: it means some state‑licensed pharmacies can lawfully compound tirzepatide in narrow, individualized circumstances — but public claims that any given pharmacy broadly offers tirzepatide compounding are not supported in the cited reporting [4] [11].
6. Practical takeaways for clinicians and patients seeking specifics
If you seek a named, state‑licensed pharmacy that lawfully compounds tirzepatide now, current reporting recommends verifying the pharmacy’s license and practices with the state board of pharmacy and asking for evidence such as a certificate of analysis or PCAB accreditation; many consumer and industry pieces also stress that publicly advertised lists are inconsistent and that pharmacies must comply with federal/state rules [12] [13] [14]. Available sources do not supply an authoritative, up‑to‑date list of specific U.S. compounding pharmacies that currently have policies permitting routine tirzepatide compounding after the FDA transition periods [1] [4].
Limitations and conflicts in coverage
Reporting agrees on the FDA deadlines and the end of blanket discretion [1] [2], but outlets differ on how strictly state boards and courts would enforce those rules in particular cases; some consumer sites and telehealth vendors continued to advertise compounded tirzepatide in multiple states during and immediately after the transition, which risks outdated or misleading claims [15] [16]. For definitive, up‑to‑date answers about a specific pharmacy’s licensure and permissible activities, consult that pharmacy’s state board of pharmacy and the pharmacy itself; available sources do not replace those primary confirmations [12] [6].