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]. FDA separately restricts outsourcing facilities’ use of bulk ingredients and has proposed excluding tirzepatide from their bulks list [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 describes enforcement discretion on this essentially-copy issue when a compounder “fills four or fewer prescriptions of that compounded drug product during a calendar month” [1].
A separate significant-difference provision may apply to a preparation for an identified patient. 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]. A program’s personalized label does not establish this determination, and documentation does not replace the other applicable requirements. Ask the prescriber to explain the actual change and clinical difference for you.
| 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 and all applicable 503A conditions; copy restrictions, enforcement discretion and significant-difference provisions have different scopes | FDA [1] |
| 503B outsourcing facility | Bulk-ingredient restrictions | FDA says tirzepatide is on neither list; the 2026 proposal concerns exclusion from the bulks list | FDA [1], Federal Register [4] |
| “Research use only” sellers | Not an authorized human-treatment route | A research label does not authorize marketing or sale as a prescription treatment | 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]. These dates ended the cited shortage-related enforcement discretion, not every online offer or every lawful patient-specific preparation.
| 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] |
| Current source check | The cited 503B action is a proposal; check current FDA policies before acting | FDA [1] |
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: its specific semaglutide-and-B12 example uses the same route and strengths within 10% of the respective commercially available products. That example illustrates the copy analysis, rather than establishing an automatic legal exemption for tirzepatide additives [1].
A geographically limited 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]. The paper includes Eli Lilly affiliations, relevant because Lilly 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]. The cited documents describe a proposal and comment extension, not a final determination. A 503B bulks-list decision concerns that pathway; it should not be substituted for analysis of the separate 503A conditions or a specific prescription. 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 per 28-day supply at the 2.5 mg starting dose and $399 at 5 mg as of this update [8]. Eligible higher-dose offers cost $449 per 28-day supply with qualifying refills within 45 days; otherwise listed prices are $499 at 7.5 mg and $699 at 10–15 mg. Needles and separate clinical fees are not included. 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 screening and a prescription by a licensed healthcare professional
- has no licensed healthcare professional available after delivery
- has spelling errors on the label or the wrong pharmacy address
- names a pharmacy on the label that you think might be fake