- Compounded medicines are not FDA-approved. The FDA does not review them for safety, effectiveness or quality.
- The semaglutide and tirzepatide shortages ended in 2024 and 2025, which narrowed what pharmacies may compound.
- In April 2026 the FDA proposed stopping large outsourcing facilities from compounding these drugs. It is not final yet.
- The FDA has received hundreds of adverse event reports, many involving dosing errors.
- Check for a prescription, a named licensed pharmacy and a LegitScript certification you can confirm.
What compounding is
Compounding is when a pharmacy mixes a medicine itself rather than dispensing a product made by a drug company. Compounded drugs are not FDA-approved, which means the agency does not review them for safety, effectiveness or quality before they reach patients.[1]
Two kinds of facility can compound. State-licensed pharmacies (known as 503A pharmacies, after the section of federal law that covers them) make medicines for individual prescriptions. Outsourcing facilities (503B) can make larger batches.[2, 3]
Where the rules stand
While semaglutide and tirzepatide were on the FDA's shortage list, compounders were allowed to make copies of them. The FDA then declared both shortages over: tirzepatide on December 19, 2024 and semaglutide on February 21, 2025.[2]
| State-licensed pharmacies (503A) | Outsourcing facilities (503B) | |
|---|---|---|
| Tirzepatide: FDA's grace period ended | February 18, 2025 | March 19, 2025 |
| Semaglutide: FDA's grace period ended | April 22, 2025 | May 22, 2025 |
From the FDA's compounding policy page.[2]
Since then, the FDA says compounders cannot regularly make drugs that are essentially copies of an approved product, in the same strength and by the same route, unless a prescriber documents a significant difference for the individual patient.[2]
On April 30, 2026, the FDA proposed excluding semaglutide and tirzepatide from the list of substances outsourcing facilities may use, saying there is no clinical need for them to compound these drugs. Comments closed on June 29, 2026. This is a proposal, not a final decision.[3]
In March 2026, the FDA warned 30 telehealth companies about illegal marketing of compounded GLP-1s, including claims that implied their products were the same as FDA-approved medicines.[4]
What the FDA warns about
As of May 31, 2026, the FDA had received 990 adverse event reports linked to compounded semaglutide and more than 730 linked to compounded tirzepatide. Many involved dosing errors, some needing hospital care.[1]
The FDA's red flags for telehealth sellers include:[1]
- claims that a compounded version is the same as an FDA-approved drug;
- prices that look too good to be true;
- product that looks different from one delivery to the next, or arrives damaged;
- no screening by a licensed clinician, and no support after you buy;
- labeling errors or pharmacy names you cannot verify.
The FDA also warns that salt forms such as semaglutide sodium should not be used in compounding, and that these medicines need to stay properly cold during shipping.[1]
How to check a provider
- A real prescription
A licensed US clinician should review your health history before prescribing. The FDA advises getting a prescription from a licensed provider and filling it only at a state-licensed pharmacy.[1]
- A named, licensed pharmacy
Ask which pharmacy makes your medicine, then check its license with your state board of pharmacy, using the FDA's BeSafeRx locator or NABP's tools.[6, 7] A provider that will not name its pharmacy is a warning sign.
- LegitScript certification you can confirm
LegitScript certifies healthcare businesses against standards that include licensing, legal compliance, valid prescriptions and accurate advertising. Confirm a seal on LegitScript's own website rather than trusting the badge.[5]
- Honest marketing
Be wary of any seller that says its product is the same as an approved medicine, or that sells without a prescription or labels products "research use only".[1, 4]
Any provider we link to has passed our own monthly checks. See how we check partners. Passing our checks is not a medical or legal endorsement. To compare what certified providers charge, see ourcompounded GLP-1 price tracker.
Branded options
If cost is the reason you are looking at compounded medicines, the makers of the branded drugs now sell them directly at self-pay prices, and some insurance plans and Medicare programs cover them. See our guides toZepbound savings and Wegovy and Ozempic savings, and the Foundayo pill guide. Our GLP-1 price checker lists branded prices by dose and is checked every week.
Common questions
Is compounded semaglutide FDA-approved?
No. The FDA says compounded drugs are not FDA-approved, which means it does not review them for safety, effectiveness or quality before they reach patients. The same applies to compounded tirzepatide.
Is compounded semaglutide or tirzepatide legal?
Compounding itself is legal when a licensed pharmacy follows federal and state rules. Since the shortages of semaglutide and tirzepatide ended, the FDA says pharmacies cannot regularly make copies of approved drugs unless a prescriber documents a significant difference for an individual patient. In April 2026 the FDA also proposed stopping large outsourcing facilities from compounding these drugs. Rules are changing, so check the latest FDA guidance.
Is compounded semaglutide the same as Wegovy or Ozempic?
No. A compounded product is not Wegovy, Ozempic or any other approved medicine, and it has not been through FDA review. The FDA lists claims that compounded versions match approved drugs as a red flag.
How do I check a compounded GLP-1 provider?
Look for a prescription from a licensed clinician, a named state-licensed pharmacy, and a LegitScript certification you can confirm on LegitScript's own website. Avoid anything sold without a prescription or labeled "research use only".
Why is compounded tirzepatide often cheaper?
Compounded products skip the FDA approval process and are made by pharmacies rather than the drug maker. The FDA lists suspiciously low prices among its warning signs, so a low price alone is not a reason to trust a seller.
Sources
- US Food and Drug Administration. FDA's concerns with unapproved GLP-1 drugs used for weight loss. Revised Content current as of 10/01/2026. Last checked 2026-10-01.
- US Food and Drug Administration. FDA clarifies policies for compounders as national GLP-1 supply begins to stabilize. Revised Content current as of 04/01/2026. Last checked 2026-10-06.
- US Food and Drug Administration (press announcement). FDA proposes to exclude semaglutide, tirzepatide, and liraglutide on 503B bulks list. Revised April 30, 2026. Last checked 2026-10-06.
- US Food and Drug Administration (press announcement). FDA warns 30 telehealth companies against illegal marketing of compounded GLP-1s. Revised March 3, 2026. Last checked 2026-10-06.
- LegitScript. Healthcare certification. Revised n/a (web page). Last checked 2026-10-06.
- US Food and Drug Administration. BeSafeRx: Locate a state-licensed online pharmacy. Revised n/a (web page). Last checked 2026-10-01.
- National Association of Boards of Pharmacy (NABP). Buy safely online. Revised n/a (web page). Last checked 2026-10-01.