Compounded tirzepatide is still available in the U.S. as of this update, but only through patient-specific prescriptions filled by state-licensed pharmacies; the broad shortage-era copying ended in March 2025 [1]. Outsourcing facilities have no current basis to make it, and FDA has proposed keeping it that way [3].
The short answer: yes, through individual prescriptions
A state-licensed 503A pharmacy may compound tirzepatide for one patient’s prescription. What it may not do is copy Zepbound or Mounjaro “regularly or in inordinate amounts.” FDA has said it won’t take action if a compounder “fills four or fewer prescriptions of that compounded drug product during a calendar month” [1].
Past that limit, a copy needs a documented reason. The exception applies when “a prescriber determines and documents the compounded drug product contains a change that produces a significant difference from the commercially available drug product for an identified individual patient” [1]. That’s why so many programs describe their tirzepatide as “personalized.” The label alone doesn’t meet the test. The prescriber’s documented reason, for you specifically, does.
| Maker | Allowed? | Condition | Source |
|---|---|---|---|
| Eli Lilly (Zepbound, Mounjaro) | Yes | Approved drug, sold under its labels | Drugs@FDA [6] [7] |
| 503A pharmacy (state-licensed) | Yes, narrowly | Individual prescriptions; not routine copies; four or fewer copies a month unless a prescriber documents a significant difference | FDA [1] |
| 503B outsourcing facility | No current basis | Not on FDA’s shortage list or 503B bulks list; exclusion proposed May 1, 2026 | FDA [1], Federal Register [4] |
| “Research use only” sellers | No | Illegal for human use; FDA has warned companies selling these | FDA [2] |
503A and 503B are sections of the federal drug law: 503A covers pharmacies compounding for named patients, 503B covers FDA-registered outsourcing facilities.
What happened: the shortage ended in December 2024
Tirzepatide injection had been in shortage since 2022, which let pharmacies make copies. FDA first called the shortage resolved on October 2, 2024. A lawsuit sent the decision back to FDA for another look, and FDA issued a new decision on December 19, 2024: “the tirzepatide injection shortage is resolved” [1].
FDA then gave 503A pharmacies until February 18, 2025 and 503B facilities until March 19, 2025 to wind down. On March 5, 2025, a court denied the challengers’ request for a preliminary injunction, and FDA said the 503A grace period had ended [1]. That’s when the broad, shortage-era market for compounded tirzepatide closed.
| Date | Event | Source |
|---|---|---|
| October 2, 2024 | FDA first declares the tirzepatide shortage resolved | FDA [1] |
| October 17, 2024 | FDA sends a letter on its approach while it reevaluates | FDA [1] |
| October 22, 2024 | Decision goes back to FDA for reevaluation after a lawsuit | FDA [1] |
| December 19, 2024 | FDA’s final decision: the shortage is resolved | FDA [1] |
| February 11, 2025 | FDA ties the grace periods to the court’s decision date | FDA [1] |
| February 18, 2025 | Stated end of the 503A grace period | FDA [1] |
| March 5, 2025 | Court denies a preliminary injunction; 503A grace period ends | FDA [1] |
| March 19, 2025 | 503B grace period ends | FDA [1] |
| April 1, 2026 | FDA reminder: tirzepatide is on neither the 503B bulks list nor the shortage list | FDA [1] |
| April 30, 2026 | FDA proposes not to include tirzepatide on the 503B bulks list | FDA [3] |
| May 1, 2026 | Proposal published in the Federal Register | Federal Register [4] |
| June 26, 2026 | Comment period extended | Federal Register [5] |
| July 30, 2026 | Extended comment period closes | Federal Register [5] |
| As of this update | No final 503B decision published | Federal Register |
FDA’s press release gave June 29, 2026 as the original comment deadline; the Federal Register notice set June 30, then extended it to July 30.
Why sellers still offer it
Many programs now sell “personalized” tirzepatide, often with vitamin B12 or glycine added. FDA says an add-in doesn’t automatically make a product different: a GLP-1 and B12 injection can still be “essentially a copy” when both strengths are “within 10%” of the approved products [1].
The add-in market is large. A secret-shopper study of 75 clinics and med spas in West Virginia and Oklahoma, done from August to October 2025, after the shortages ended, found 56.0% offering GLP-1 drugs combined with B vitamins [9]. Of 21 supplier facilities checked, 4 weren’t licensed for sterile compounding.
Add-ins raise their own questions. A 2026 lab study found a new impurity in compounded tirzepatide and B12 products, formed when the two react [10]. All of its authors work for Eli Lilly, which sells Zepbound, and the authors say the impurity’s “clinical effects … are unknown.” What’s in the vial, and why it matters, is covered in compounded tirzepatide explained.
Is compounded tirzepatide FDA-approved? No
No. FDA says compounded drugs “are not FDA approved,” which means it “does not review compounded drugs for safety, effectiveness or quality before they are marketed” [2]. The approved tirzepatide products are Mounjaro, approved in May 2022 for type 2 diabetes, and Zepbound, approved in November 2023 for weight management [6] [7]. How the two compare with a compounded vial is in compounded tirzepatide vs Zepbound.
Is it going away? What could change next
There’s no federal end date for 503A compounding. What’s pending is the 503B question. On April 30, 2026, FDA announced it was proposing not to include tirzepatide, semaglutide and liraglutide on the 503B bulks list, “finding no clinical need for outsourcing facilities to compound these drugs from bulk substances” [3]. The Federal Register notice followed on May 1 [4], and the comment period closed July 30, 2026 [5].
FDA says it will “consider submitted comments before making a final determination” [3]. No final notice has been published as of this update. A final exclusion would close the 503B door that’s already shut in practice. It wouldn’t, on its own, change the 503A patient-specific route. State pharmacy boards can also act on pharmacies in their states, and FDA has warned companies that sold unapproved GLP-1 products illegally [2].
Semaglutide is in the same position, with a slightly different history. See will compounded semaglutide be banned.
If your compounded supply stops
Your options are a brand switch, insurance coverage or another licensed program, and the switch itself is a prescriber’s decision. Zepbound through LillyDirect lists at $299 a month for the 2.5 mg starting dose and $399 for 5 mg as of this update [8]. Higher doses are $449 when you refill within 45 days. Lilly notes that 2.5 mg “is a starting dose and is not approved as a maintenance dose.”
Don’t convert a compounded dose to a brand dose on your own. Products differ, and your prescriber will decide where to start. What each route costs month to month is in how much compounded tirzepatide costs, and the legal routes to a prescription are laid out in where compounded tirzepatide is still prescribed.
What to ask your prescriber now
- What documented reason makes a compounded product right for me instead of Zepbound?
- Which pharmacy fills my prescription, and is it a 503A pharmacy licensed in my state?
- What’s in my vial besides tirzepatide?
- If compounded supply ends, what’s the plan to move me to a brand product, and what would it cost?
How to check a program is still legitimate
Start with the pharmacy. Ask which one fills your prescription, then look up its license with your state board of pharmacy. FDA’s list of warning signs is a good second filter. Be wary of any company that [2]:
- claims its compounded drug is the same as an FDA-approved drug
- offers deep discounts or prices that seem too good to be true
- sends medicine that looks different from before, or arrives damaged or without instructions
- doesn’t require a screening and prescription by a licensed doctor
- has no licensed doctor available after you get your medicine
- has spelling errors on the label or the wrong pharmacy address
- names a pharmacy on the label that you think might be fake
Programs that still offer compounded tirzepatide right now include Strut Health and Eden, among many others; each review shows what the program’s own pages say about its pharmacy and prescribers. Side by side, they’re on the compounded tirzepatide providers scorecard. How those scores are built is explained on how we score.