When GLP-1 medications were in short supply, compounded versions became common, often through telehealth. The shortages are now over, the rules have tightened, and many people are unsure what is allowed. This guide explains the real differences between brand-name and compounded GLP-1s and what the FDA says as of October 2026.
Key takeaways
- Brand-name GLP-1s like Wegovy, Ozempic, Zepbound and Mounjaro are FDA-approved. Compounded versions are not.
- The FDA declared the tirzepatide shortage resolved in December 2024 and the semaglutide shortage resolved in February 2025.
- The temporary grace periods that let pharmacies make large amounts of copies ended in 2025.
- In 2026 the FDA sent warning letters to dozens of telehealth companies over misleading claims about compounded GLP-1s.
- If you use any GLP-1, get it with a valid prescription from a state-licensed pharmacy.
What compounding is
Compounding is when a pharmacist mixes or alters ingredients to make a drug for a specific patient. It has a real place in medicine. For example, a patient may need a version without a dye they are allergic to, or a liquid form for someone who cannot swallow pills.
There are two main types of compounders in the US:
- 503A pharmacies are state-licensed pharmacies that compound for individual patients based on prescriptions.
- 503B outsourcing facilities register with the FDA, follow stricter manufacturing standards and can make larger batches.
How brand-name and compounded GLP-1s differ
| Brand-name (FDA-approved) | Compounded | |
|---|---|---|
| FDA review before sale | Yes, for safety, effectiveness and quality | No |
| Proven in clinical trials | Yes, the exact product | No, the specific product was not tested |
| Manufacturing standards | Full FDA drug manufacturing rules | 503A follows pharmacy rules; 503B follows stricter federal standards |
| Ingredient source | Approved manufacturing process | Varies; FDA has raised concerns about some sources |
| Dosing form | Prefilled pens or tablets with fixed doses | Often multi-dose vials you draw yourself |
| Label and instructions | FDA-approved label | Pharmacy label |
That last row matters. Prefilled pens make dosing simpler. Vials require you to measure the right amount with a syringe, and the FDA has received reports of people measuring wrong amounts, sometimes leading to hospital care.
Where things stand in 2026
The shortages ended
Under federal law, compounders get more room to copy an approved drug while it is on the FDA shortage list. During the shortage period, many pharmacies made semaglutide and tirzepatide. According to the FDA:
- The tirzepatide shortage was declared resolved, with a final determination on December 19, 2024.
- The semaglutide shortage was declared resolved on February 21, 2025.
- Grace periods followed. For semaglutide, the period for 503A pharmacies ended in April 2025 and for 503B outsourcing facilities on May 22, 2025. The tirzepatide periods ended in March 2025.
After that, compounders generally cannot make what are essentially copies of a commercially available drug. Patient-specific compounding for a real medical need, such as an allergy to an ingredient, may still be allowed under the rules.
FDA actions against misleading marketing
In March 2026 the FDA announced warning letters to 30 telehealth companies over how they marketed compounded GLP-1s. The agency objected to claims that compounded products are the same as approved drugs, and to branding that could mislead people about who actually makes the product. Earlier warning letters went out in September 2025.
Safety reports and ingredient concerns
The FDA's GLP-1 safety page, updated October 1, 2026, says that as of May 31, 2026 it had received 990 adverse event reports tied to compounded semaglutide and more than 730 tied to compounded tirzepatide. The agency believes these are undercounted. It also warns that:
- Salt forms like semaglutide sodium and semaglutide acetate are different ingredients from the approved drug, with no known lawful basis for compounding.
- Counterfeit Ozempic has been found in the US supply chain.
- Products labeled "for research purposes" or "not for human consumption" are not safe to use. This includes semaglutide, tirzepatide, retatrutide and others sold that way.
Red flags the FDA lists
The FDA tells consumers to watch for these warning signs with telehealth sellers:
- Claims that a compounded drug is "the same as" or "generic" Wegovy or Zepbound.
- Prices that seem unusually low.
- No real screening by a licensed prescriber before you get a prescription.
- Labels with errors or missing information.
- Medication that arrives warm or without proper cold packaging.
Our guide to verifying a telehealth provider walks through these checks, and our telehealth page explains what licensed care looks like.
If you are currently using a compounded GLP-1
Do not stop or switch abruptly without a plan. Talk with your prescriber about:
- Whether your compounded product is still being made lawfully, and by what type of pharmacy.
- Whether an FDA-approved option, including newer lower-cost or oral options, could work for you.
- How switching would affect your dose plan. Doses are not always one-to-one between products.
If you keep using a vial product, the FDA advises throwing away multi-dose vials 28 days after first use, using a new sterile needle and syringe each time, and reporting any problems to MedWatch. Double-check every dose. Our dose calculator can help convert a prescribed dose into syringe units.
Cost and access
Cost is the main reason people chose compounded versions. Since then, access options have expanded. Generic liraglutide is available and oral options like the Wegovy pill and Foundayo were approved. Insurance coverage varies widely. Ask your prescriber and pharmacist what is covered for you.
The bottom line
Brand-name GLP-1s have been tested and approved by the FDA. Compounded versions have not, and the rules that allowed wide compounding ended with the shortages. If you use a GLP-1, get it through a licensed prescriber and a state-licensed pharmacy, and ask direct questions about what you are getting.
Sources
- FDA clarifies policies for compounders as national GLP-1 supply begins to stabilize
- FDA's concerns with unapproved GLP-1 drugs used for weight loss
- FDA's latest GLP-1 crackdown (Venable, March 2026)
Frequently asked questions
Is compounded semaglutide FDA-approved?
No. Compounded drugs are not FDA-approved, which means the FDA has not reviewed them for safety, effectiveness or quality before sale. Brand-name Wegovy and Ozempic are FDA-approved.
Can pharmacies still compound semaglutide and tirzepatide?
The FDA declared the shortages over (tirzepatide in December 2024 and semaglutide in February 2025), and the grace periods for mass compounding ended in 2025. Pharmacies may still compound for a specific patient with a documented medical need that an approved drug cannot meet, under federal and state rules. Ask your prescriber and pharmacy how their product meets these rules.
Is semaglutide sodium the same as semaglutide?
The FDA says salt forms such as semaglutide sodium and semaglutide acetate are different active ingredients from the one in approved products, and it knows of no lawful basis for using them in compounding.