Short answer: Brand semaglutide (Ozempic, Wegovy, Rybelsus) is FDA approved. Compounded semaglutide is not, so FDA has not reviewed it for safety, effectiveness or quality.1 FDA declared the semaglutide shortage over on February 21, 2025.2 It has warned about dosing errors from vials measured in "units" and about salt forms that differ from the approved drug.3
This page sets out what FDA has published about compounded semaglutide. It does not say where to get any product. If you already use compounded semaglutide, the dosing section is the part worth reading closely.
| Brand (Ozempic, Wegovy, Rybelsus) | Compounded semaglutide | |
|---|---|---|
| FDA approval | Approved; reviewed for safety, effectiveness and quality4 | Not approved; not reviewed by FDA before sale1 |
| Active ingredient | Semaglutide base form3 | Should be the same, but FDA has seen salt forms (semaglutide sodium, semaglutide acetate), which are different active ingredients1 |
| How the dose is measured | In milligrams, from pens or syringes with fixed strengths54 | Often in "units" drawn from a vial; concentration varies by compounder3 |
| Container | Prefilled pens and syringes, or tablets54 | Multi-dose vials or prefilled syringes3 |
| Multi-dose vial use | Ozempic pens: use within 56 days5 | FDA advises throwing away a multi-dose vial 28 days after first use, whatever the label says1 |
| Added ingredients | None beyond the approved formula | Some add B12, B6, L-carnitine or NAD; FDA says the safety and effectiveness of these combinations is not established3 |
| Shortage status | Shortage declared resolved February 21, 20252 | Shortage-based compounding windows ended in 2025 (pharmacies April 2025, outsourcing facilities May 22, 2025)6 |
| Adverse event reporting | Required from the manufacturer | Most pharmacies are not required to report, so events are likely underreported; FDA had 990 reports as of May 31, 20261 |
Semaglutide injections were on FDA's shortage list from 2022. While a drug is in shortage, compounders have more room to make copies of it. On February 21, 2025, FDA found that Novo Nordisk's supply met or exceeded demand and declared the shortage resolved.2
FDA then gave compounders a wind-down period: state-licensed pharmacies until April 22, 2025 (ended after a court ruling that month) and outsourcing facilities until May 22, 2025.6 In April 2026 FDA said semaglutide is on neither its shortage list nor the 503B bulks list, reminded pharmacies of limits on making "essentially copies" of approved drugs, and proposed keeping semaglutide off the 503B bulks list.67
Brand injections are dosed in milligrams from pens or syringes set to a fixed strength. Compounded semaglutide often comes in a multi-dose vial at a concentration that varies by compounder, with instructions in "units" on an insulin syringe.3 FDA's reports describe:
FDA has also received reports tied to compounded doses higher than the approved labels, or faster step-ups.1 Because semaglutide's half-life is about a week, an overdose can take a long time to wear off.3
The approved drugs contain semaglutide in its base form. Some compounders have used semaglutide sodium or semaglutide acetate. FDA says these are different active ingredients, it has no information that they behave the same in the body, and it knows of no lawful basis for compounding with them.1 FDA's advice is that compounded drugs should be used only when an approved drug cannot meet a patient's medical needs, and that problems should be reported to MedWatch.1