Compounded semaglutide after the shortage: what changed on February 21, 2025 and since

For almost three years compounded semaglutide existed in a regulatory gap opened by a shortage. On February 21, 2025 FDA closed it. This page is about what that order said, what FDA has said since, and what it means for anyone still being prescribed a compounded product. FormBlends, which runs this site, dispenses compounded semaglutide through licensed pharmacies; read that disclosure alongside everything below.

The order

FDA's declaratory order of February 21, 2025 determined that the semaglutide injection product shortage was resolved. It records that Wegovy had been in shortage since March 2022 and Ozempic since August 2022, and that Novo Nordisk's supply now met or exceeded demand, while noting that patients and prescribers might still see intermittent localized supply disruptions.

The consequence was in the wind-down dates. Compounders had relied on the shortage listing to make what would otherwise be "essentially a copy" of a commercially available drug, which sections 503A and 503B of the Federal Food, Drug and Cosmetic Act restrict. The order gave state-licensed pharmacies and physicians compounding under 503A 60 days, until April 22, 2025, and outsourcing facilities under 503B 90 days, until May 22, 2025, before FDA would begin enforcing against shortage-based copies. It explained the longer 503B window by the greater quality assurances outsourcing facilities operate under, including current good manufacturing practice requirements that 503A pharmacies are not subject to.

What FDA says about the product itself

FDA's page on unapproved GLP-1 drugs (content current September 1, 2026) makes four points worth quoting closely.

Not approved. "Compounded drugs are not FDA approved. This means the agency does not review compounded drugs for safety, effectiveness or quality before they are marketed."

Dosing errors. FDA has received adverse event reports involving patients who measured and self-administered incorrect doses of compounded injectable semaglutide, and health care professionals who miscalculated doses. Some cases required hospitalization. It has also seen prescriptions exceeding the approved labels' dosing through larger single doses, more frequent dosing or faster escalation. The units converter exists for the first problem; the titration planner, which refuses steps shorter than the label minimum, exists for the third.

Salt forms. FDA has flagged products made with semaglutide sodium and semaglutide acetate, stating it lacks information on whether these salts have the same chemical and pharmacologic properties as the active ingredient in the approved drugs.

Counts. As of May 31, 2026 FDA had received 990 adverse event reports associated with compounded semaglutide and more than 730 for compounded tirzepatide. It adds that state-licensed pharmacies are not required to submit adverse event reports to FDA, so the numbers likely understate the total.

Since the order

On April 30, 2026 FDA published a Federal Register notice proposing to exclude semaglutide, tirzepatide and liraglutide from the list of bulk drug substances that 503B outsourcing facilities may compound from, on the basis that there is no clinical need for it. That is a proposal about one route of compounding; if finalised, it would narrow what outsourcing facilities can make from raw API. Follow FDA's compounding pages for the current status rather than this paragraph.

Questions for any pharmacy

If you are prescribed compounded semaglutide, these are the questions the material above suggests, and a legitimate pharmacy will answer them without hesitation.

1. Which section governs you, 503A or 503B, and in which state are you licensed? Every state board of pharmacy has a public licence lookup.
2. What is the active ingredient, exactly: semaglutide base, or a salt form? Where does it come from?
3. Is there a certificate of analysis for this lot, and may I see it?
4. What is the concentration on this vial, in mg/mL, and did it change from my last fill?
5. What syringe should I use, and what is the mark for my dose?
6. What is the beyond-use date, and how should I store it?

The Compounding Explained site in this network covers 503A versus 503B and licence verification in depth. FormBlends publishes how its own compounded semaglutide is sourced and dispensed, and the Wegovy vs compounded comparison sets the brand product against the compounded one on every axis that differs.