The short answer: the shortage exception is over
The legal window that allowed mass-produced copies of semaglutide and tirzepatide closed in 2025. Both drugs had been on the FDA shortage list since 2022, and while they stayed there, compounders had extra room to make versions that were essentially copies of the brand products. Once the FDA declared both shortages resolved, that room disappeared after short grace periods.
Compounding itself did not become illegal. What remains is narrower: a state-licensed pharmacy can compound for an individual patient, and copies of a commercially available drug are limited unless the clinician documents a change that produces a significant difference for that specific person. The rest of this article walks through the dates and what they mean for you.
The timeline, date by date
These dates come from the FDA statement on compounding policy, which the agency has updated as each step happened. You can check the current status of any drug in the FDA Drug Shortages Database.
| Date | What happened |
|---|---|
| 2022 | Semaglutide and tirzepatide injections go into shortage because of demand |
| October 2, 2024 | FDA says the tirzepatide shortage is resolved |
| October 2024 | During a lawsuit, the decision is sent back to FDA to reevaluate |
| December 19, 2024 | FDA issues a new decision: the tirzepatide shortage is resolved |
| February 21, 2025 | FDA says the semaglutide shortage is resolved |
| March 5, 2025 | Court denies an injunction on tirzepatide; FDA says the 503A grace period has ended |
| March 19, 2025 | Grace period ends for 503B outsourcing facilities making tirzepatide |
| April 24, 2025 | Court denies an injunction on semaglutide; FDA says the 503A grace period has ended |
| May 22, 2025 | Grace period ends for 503B outsourcing facilities making semaglutide |
| April 1, 2026 | FDA restates the 503A conditions, including how it treats add-in ingredients |
The grace periods were set at 60 days for state-licensed pharmacies and 90 days for outsourcing facilities, measured from each resolution announcement. For pharmacies, the cutoffs were tied to court rulings in the industry lawsuits, which is why the effective end dates fell in March and April 2025 rather than on the original dates.
503A and 503B: two kinds of compounders
Federal law sorts compounders into two groups, and the rules land differently on each. A short explainer on 503A vs 503B compounding pharmacies covers the background in more depth.
- 503A pharmacies are state-licensed pharmacies, overseen mainly by state boards of pharmacy. They compound for named patients based on an order from a licensed clinician.
- 503B outsourcing facilities are a category created in 2013 by the Drug Quality and Security Act. The FDA’s compounding questions and answers explains that these facilities are inspected by FDA on a risk-based schedule and held to higher quality standards.
For 503B facilities the door is now mostly shut. They may compound from bulk ingredients only when the substance is on the 503B bulks list or the finished drug is on the shortage list, and the FDA says neither semaglutide nor tirzepatide currently appears on either list.
What individualized 503A compounding still allows
The April 2026 FDA update spells out the test. A compounded product counts as essentially a copy of a commercially available drug when it has the same active ingredient in the same, similar or an easily substitutable strength, and the approved product can be given by the same route. That is unless the clinician who orders it determines and documents a change that produces a significant difference for an identified individual patient.
Three details in that update matter for anyone weighing a compounded GLP-1:
- Add-ins do not automatically make a new product. The FDA gave the example of semaglutide combined with vitamin B12. If both ingredients sit within 10% of the strengths of commercially available products given the same way, the agency may still treat it as a copy.
- Small volumes are tolerated. The FDA said it does not intend to act against a pharmacy that fills four or fewer orders of a given essentially-copy product in a calendar month. That is not a business model for supplying large numbers of patients.
- The documentation has to be real. The significant difference must be determined and recorded for one identified person, not stamped on every order.
None of this changes the basic status of a compounded drug. It is not FDA-approved, and the agency does not review it for safety, effectiveness or quality before it is sold.
The safety problems the FDA keeps flagging
The FDA’s page on concerns with unapproved GLP-1 drugs, updated October 1, 2026, lists the issues it is seeing:
- Adverse event reports. As of May 31, 2026, the agency had received 990 reports tied to compounded semaglutide and more than 730 tied to compounded tirzepatide. Because most pharmacies are not required to report, the FDA says these are likely undercounts.
- Dosing errors. Some patients measured the wrong amount from multi-dose vials, and some health professionals miscalculated doses. Others received doses or step-ups beyond the approved labels.
- Salt forms. Semaglutide sodium and semaglutide acetate are different active ingredients from the approved drug, and the FDA knows of no lawful basis for compounding them.
- Fraudulent labels. Some products name pharmacies that do not exist or that never made the product.
- Unapproved molecules. Retatrutide and cagrilintide cannot be used in compounding under federal law. Our page on retatrutide explains where that drug stands in trials.
The same page lists red flags for online sellers: claims that a compounded drug is the same as an approved one, prices that seem too good to be true, and no screening by a licensed clinician before medicine ships.
What this means for men on a GLP-1 now
If you started a compounded GLP-1 during the shortage, the ground has shifted under you. The supply you were using may have changed hands, changed form or disappeared. That is a good moment to review where your medicine comes from, what is actually in the vial and whether an FDA-approved product fits your situation. Our comparison of compounded semaglutide vs Wegovy lays out those differences side by side, and the answer page on whether compounded semaglutide is legal in 2026 covers the common follow-up questions.
Do not change your dose or switch products on your own. GLP-1 doses are stepped up gradually for a reason, and a jump between formulations can bring on the nausea, vomiting and dehydration the FDA describes in its reports.
How Ultimate Male approaches GLP-1 care under the current rules
At our San Gabriel and Downey clinics, every medical weight loss plan starts with labs and a one-on-one consultation with a PA-C or MD, before any medicine is discussed. Part of that visit is a plain conversation about the form of semaglutide or tirzepatide: whether an FDA-approved product fits you, and what the current rules allow if it does not. Any compounded medicine the clinic uses comes from a licensed U.S. compounding pharmacy.
If you are already on a GLP-1 elsewhere and want a second look at your plan, the page on transferring GLP-1 care explains what to bring. Start with the free 10-minute phone call, and ask anything about sourcing before you book.
