Is Compounded Tirzepatide Legal in 2026? What FDA Rules Say
No. Mass compounding of tirzepatide became unlawful after FDA resolved the shortage in December 2024 and grace periods closed in 2025. Only narrow 503A exceptions remain, and FDA has received more than 730 adverse event reports for compounded tirzepatide.
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No — mass compounding of tirzepatide is not legal in the United States in 2026. Tirzepatide appears on neither the 503B bulks list nor FDA’s drug shortage list as of FDA’s April 1, 2026 update [1], and the Fifth Circuit Court of Appeals held that removal from the shortage list made compounding tirzepatide injections unlawful for physicians, pharmacies and outsourcing facilities [5]. What remains is a narrow exception for state-licensed pharmacies and physicians compounding for an individual patient when a prescriber determines and documents a significant difference from the approved product [1]. Compounded drugs are not FDA-approved and do not go through premarket review for safety, effectiveness or quality [3]. This page describes the rules only; decisions about treatment belong with a licensed clinician [3].
Why was compounded tirzepatide legal in the first place?
Federal law lets two kinds of compounders operate. Under section 503A of the FD&C Act, a state-licensed pharmacy or physician may compound a drug for an individual patient based on a prescription, but may not compound “regularly or in inordinate amounts” of drugs that are essentially copies of a commercially available drug [1]. Under section 503B, outsourcing facilities may compound with bulk drug substances only if the substance is on the 503B bulks list, or if the drug compounded from it is on FDA’s drug shortage list at the time of compounding, distribution and dispensing [1].
The compounding prohibition is temporarily suspended while a drug is on the FDA shortage list [5]. Tirzepatide injection was added to the shortage list on December 15, 2022, and Zepbound was added in April 2024 [2]. Mounjaro was approved in May 2022 and Zepbound in November 2023, and they are the only FDA-approved tirzepatide products [2][5]. While the shortage lasted, pharmacies and outsourcing facilities that met the statutory conditions could compound tirzepatide to satisfy demand [5].
When did the shortage end and compounding stop?
FDA first determined the tirzepatide shortage was resolved on October 2, 2024. After a lawsuit forced a reevaluation, FDA issued a declaratory order on December 19, 2024 that revoked and replaced the October decision and again determined the shortage was resolved [2].
| Date | What happened |
|---|---|
| December 15, 2022 | Tirzepatide injection added to FDA’s drug shortage list [2] |
| October 2, 2024 | FDA first declared the shortage resolved [2] |
| December 19, 2024 | Declaratory order revoked and replaced the October decision; shortage again declared resolved [2] |
| February 18, 2025 | Enforcement-discretion period ended for 503A pharmacies and physicians [2] |
| March 19, 2025 | Enforcement-discretion period ended for 503B outsourcing facilities [2] |
| August 27, 2026 | Fifth Circuit affirmed judgment for FDA [5] |
To ease the transition, FDA said it did not intend to take action against compounders for violations tied to the shortage-listing for 60 calendar days for 503A pharmacies and physicians (until February 18, 2025) and 90 calendar days for 503B outsourcing facilities (until March 19, 2025) [2]. On February 11, 2025, FDA clarified that those deadlines applied or the date of the district court’s preliminary-injunction ruling, whichever was longer [1]. The district court denied the injunction on March 5, 2025, and FDA’s March 10, 2025 update confirmed the 503A period had ended and the 503B period would run until March 19, 2025 [1].
FDA’s basis was Eli Lilly’s data showing supply meeting or exceeding demand, with reserves in finished-product inventory plus scheduled additional production [2]. FDA noted patients might still see intermittent, localized supply disruptions [2].
What happened in the compounders’ lawsuit?
The Outsourcing Facilities Association and FarmaKeio Custom Compounding sued FDA on October 7, 2024 in the Northern District of Texas (No. 4:24-cv-953), and the decision was remanded to the agency for reevaluation on October 11, 2024 [2]. The compounders argued FDA should have used notice-and-comment rulemaking and that the shortage finding was arbitrary and capricious [5].
The district court denied their preliminary-injunction motion and later entered summary judgment for FDA and for Eli Lilly as intervenor [5]. The Fifth Circuit affirmed on August 27, 2026 in an unpublished per curiam opinion (No. 25-10600). The panel assumed without deciding that FDA erred by skipping notice-and-comment procedures, but found the compounders showed no prejudice, and it held the shortage determination was not arbitrary or capricious [5].
A parallel appeal over semaglutide and Novo Nordisk was before the same panel and received a separate opinion [5]. The Fifth Circuit’s opinion also noted that Lilly spent about $23 billion expanding manufacturing capacity while the drugs were in shortage, and that Lilly’s exclusivity for tirzepatide extends to 2027 [5].
Can compounding pharmacies still make tirzepatide at all?
Only in narrow circumstances. FDA considers a compounded drug to be essentially a copy of a commercially available drug when it has the same active pharmaceutical ingredient in the same, similar or easily substitutable strength, and the approved drug can be used by the same route of administration [1]. That is unlawful under 503A unless the prescriber determines and documents a change that produces a significant difference for an identified individual patient [1].
FDA has also stated that, at this time, it does not intend to take action against a compounder for compounding an essentially-a-copy product regularly or in inordinate amounts if the compounder fills four or fewer prescriptions of that product during a calendar month [1]. That is an enforcement statement, not a statutory safe harbor written into law.
The 503B route is closed: tirzepatide is on neither the 503B bulks list nor the shortage list, so outsourcing facilities cannot lawfully compound it from bulk substance [1]. Compounders have argued that the narrow personalization provision allows products such as added vitamins or doses not available in the branded versions [6].
Does adding vitamin B12 make compounded tirzepatide legal?
Not by itself. FDA applies a two-or-more-products test: a compounded product containing the same APIs as two or more commercially available products, in the same, similar or easily substitutable strength and used by the same route, is considered essentially a copy unless a prescriber documents a significant difference [1]. FDA’s worked example for this test names semaglutide plus vitamin B12 (cyanocobalamin) in an injectable, with each ingredient within 10% of marketed strengths [1]. The same test applies to combinations generally, including tirzepatide combinations.
On March 12, 2026, Eli Lilly released a public letter saying its own testing found significant levels of an impurity produced by a chemical reaction between tirzepatide and B12, in all 10 samples tested. Lilly said it notified FDA and called for a nationwide recall of products containing both ingredients [6]. That finding is Lilly’s testing, not an FDA finding. Scott Brunner, CEO of the Alliance for Pharmacy Compounding, said Lilly had not disclosed enough about its sampling process to fully assess the risk to consumers [6].
What does FDA say about safety?
As of May 31, 2026, FDA had received more than 730 adverse event reports associated with compounded tirzepatide and 990 associated with compounded semaglutide. State-licensed pharmacies that are not outsourcing facilities are not required to report adverse events to FDA, so the agency says these events are likely underreported [3].
FDA has received adverse event reports that may be related to patients prescribed compounded semaglutide or tirzepatide in doses beyond what is in the FDA-approved label. Separately, FDA received multiple reports of adverse events, some requiring hospitalization, tied to dosing errors with compounded injectable semaglutide products [3].
FDA also flags other concerns: multi-dose vials should be discarded within 28 days after first use even if the compounder’s instructions say longer, with a new sterile needle and syringe for each dose; injectable GLP-1 drugs that arrive warm or with inadequate ice packs should not be used; and FDA is aware of fraudulent compounded products whose labels name pharmacies that do not exist, or licensed pharmacies that did not compound them. One adverse event report involved a product labeled as compounded tirzepatide from a pharmacy that did not compound it, with redness, swelling, pain and a red lump at the injection site [3].
What are FDA and Lilly doing about sellers?
FDA sent warning letters to 30 telehealth companies in September 2025 over false or misleading claims about compounded weight-loss drugs [6]. In June 2026, it posted 25 more warning letters to telehealth companies, including Medica Weight Loss, Ready Med and Clover Meds. The agency cited claims that compounded versions were sourced from FDA-approved pharmacies, were clinically studied, or were the same as approved drugs [7].
FDA has also warned sellers of products containing tirzepatide, retatrutide, survodutide or mazdutide labeled “for research purposes” or “not for human consumption” while being sold directly to consumers with dosing instructions. FDA states that retatrutide and cagrilintide cannot be used in compounding under federal law [3]. At the border, Import Alert 66-80 allows detention without physical examination of GLP-1 active pharmaceutical ingredients except from firms on the Green List; FDA evaluated 48 GLP-1 API sites and found 21% noncompliant, and a revised version of the alert was published August 21, 2026 [3][10].
Lilly filed lawsuits on April 23, 2025 against four telehealth companies — Mochi Health, Fella Health, Willow Health and Henry Meds — alleging that personalization claims mask mass marketing of slightly different versions of its drugs, and earlier in April 2025 sued two pharmacies over similar claims. Mochi Health said its model remains compliant with FDA guidance and pharmacy regulations [8]. The sources describe filings and allegations only.
What is the pending 503B bulks list proposal?
On April 30, 2026, FDA proposed excluding semaglutide, tirzepatide and liraglutide from the 503B bulks list, saying it did not identify a clinical need for outsourcing facilities to compound them from bulk substances [4]. “When FDA-approved drugs are available, outsourcing facilities cannot lawfully compound using bulk drug substances unless there is a clear clinical need,” FDA Commissioner Marty Makary said in the announcement [4].
The Federal Register notice was published May 1, 2026 (91 FR 23431, Docket FDA-2018-N-3240), with comments due June 30, 2026 [9]; the press announcement had invited comments through June 29, 2026 [4]. A June 26, 2026 notice extended the comment period, and 4,279 comments were received [9]. In the notice, FDA tentatively finds no attribute of the approved tirzepatide products that makes them medically unsuitable, and states that shortages and backorders are not “clinical need” for compounding with a bulk substance [9]. FDA says it will consider submitted comments before making a final determination [4].
How can you check a seller or report a problem?
FDA lists red flags for telehealth sellers: claims that a compounded drug is the same as an FDA-approved drug; prices that seem too good to be true; medicine that looks different from what you received before or arrives damaged or without instructions; no screening and prescription by a licensed doctor; no licensed doctor available afterward; and labels with spelling errors or a wrong pharmacy address [3].
FDA says patients should obtain a prescription from their doctor, fill it at a state-licensed pharmacy, and use its BeSafeRx resources for buying medicine online. FDA’s position is that compounded drugs should only be used when a patient’s medical needs cannot be met by an FDA-approved drug [3]. Adverse events or quality problems can be reported to FDA’s MedWatch program [3].
Sources
- US Food and Drug Administration. FDA clarifies policies for compounders as national GLP-1 supply begins to stabilize.
- US Food and Drug Administration. Declaratory order: resolution of shortages of tirzepatide injection products (Mounjaro and Zepbound). December 19, 2024.
- US Food and Drug Administration. FDA’s concerns with unapproved GLP-1 drugs used for weight loss.
- US Food and Drug Administration. FDA proposes to exclude semaglutide, tirzepatide, and liraglutide on 503B bulks list.
- US Court of Appeals for the Fifth Circuit. Outsourcing Facilities Association v. Food and Drug Administration. August 27, 2026.
- Reuters. Lilly finds impurity in compounded version of its weight-loss drug, warns of health risks. March 12, 2026.
- Reuters. US FDA sends 25 letters to telehealth companies over claims on compounded weight-loss drugs. June 16, 2026.
- CNBC. Eli Lilly sues compounded Mounjaro, Zepbound providers. April 23, 2025.
- Federal Register. List of bulk drug substances for which there is a clinical need under section 503B of the Federal Food, Drug, and Cosmetic Act. May 1, 2026.
- US Food and Drug Administration. Import Alert 66-80.
Frequently asked questions
Can compounding pharmacies still make tirzepatide at all?
Only under a narrow 503A exception. A state-licensed pharmacy or physician may compound for an individual patient when a prescriber determines and documents a change that produces a significant difference from the approved product. FDA has also stated it does not intend to act against a compounder filling four or fewer prescriptions of such a product in a calendar month, though that is an enforcement statement rather than a legal limit.
Is compounded Zepbound the same as compounded tirzepatide?
Yes in substance. Zepbound and Mounjaro are the only FDA-approved tirzepatide products, and both use the same active ingredient. A compounded product containing tirzepatide is not Zepbound itself, because compounded drugs are not FDA-approved and receive no premarket review for safety, effectiveness or quality.
What was the compounded tirzepatide ban date?
There was no single ban date. FDA declared the shortage resolved on December 19, 2024, then allowed grace periods that ended February 18, 2025 for 503A pharmacies and physicians and March 19, 2025 for 503B outsourcing facilities. After those dates, mass compounding of tirzepatide was unlawful.
Is tirzepatide with vitamin B12 legal?
Adding B12 does not automatically change the legal answer. FDA treats a product with the same APIs as two or more commercially available products, in similar strength and by the same route, as essentially a copy unless a prescriber documents a significant difference for an identified patient. Lilly's own testing reported an impurity from a tirzepatide-B12 reaction in all 10 samples it tested, a finding a compounding trade group said lacked sufficient disclosure to assess risk.
Is compounded tirzepatide safe?
Compounded drugs are not FDA-approved and are not reviewed for safety, effectiveness or quality before marketing. As of May 31, 2026, FDA had received more than 730 adverse event reports for compounded tirzepatide, likely underreported because most compounders are not required to report. FDA says compounded drugs should only be used when medical needs cannot be met by an approved drug.
What did the Fifth Circuit decide?
On August 27, 2026, the court affirmed judgment for FDA in Outsourcing Facilities Association v. FDA (No. 25-10600). It assumed without deciding that FDA erred by not using notice-and-comment rulemaking, found no prejudice shown, and held the shortage determination was not arbitrary or capricious.
Will tirzepatide ever go back on the shortage list?
It could. FDA stated in its December 19, 2024 declaratory order that it will continue to monitor supply and demand and whether any tirzepatide injection products should be included on the drug shortage list in the future. If a national shortage were declared again, certain compounding restrictions tied to the shortage list would be suspended.
What happens if FDA finalizes the 503B exclusion?
FDA proposed on April 30, 2026 to exclude semaglutide, tirzepatide and liraglutide from the 503B bulks list after finding no clinical need. If finalized, outsourcing facilities would remain unable to compound tirzepatide from bulk substance, since the drug is also off the shortage list. FDA says it will consider the 4,279 comments received before a final determination.
This article summarizes FDA labeling, published research and company information current as of September 14, 2026. It is not medical advice and does not replace a conversation with your own healthcare provider. How we research and verify.