Evidence explainerWomen's GLP-1 & Weight
Compounded Semaglutide and Tirzepatide: What the FDA Actually Says, and the Red Flags to Check
Compounded GLP-1s are legal in limited circumstances but are not FDA-approved, and the FDA has warned companies that market them as the same thing as the brand-name drugs. Here is the checklist.
Key takeaways
- Compounded drugs are not FDA-approved: the FDA does not review them for safety, effectiveness or quality before sale [1].
- As of May 31, 2026 the FDA had received 990 adverse-event reports for compounded semaglutide and more than 730 for compounded tirzepatide, and says these are likely underreported [1].
- The FDA's first telehealth red flag: a company claiming its compounded drug is the same as an FDA-approved drug [1].
- Hers received an FDA warning letter in September 2025 over exactly that kind of claim [2].
- Salt forms (semaglutide sodium or acetate), retatrutide and cagrilintide have no lawful basis in compounding, per the FDA [1].
What compounding is, and is not
A compounded drug is mixed by a pharmacy for an individual prescription. The FDA says compounding may be appropriate when a patient's medical need cannot be met by an FDA-approved drug or the approved drug is not commercially available, and that compounded drugs should be used only in those cases [1].
Because compounded drugs skip FDA review, results from the brand-name trials do not transfer automatically. The FDA has documented dosing errors from multi-dose vials, doses beyond the approved label, and products that arrived warm [1].
The FDA's red flags
The FDA lists these warning signs for telehealth companies selling GLP-1s [1]:
- Claims that the compounded drug is the same as an FDA-approved drug.
- Deep discounts or prices that seem too good to be true.
- Medicine that looks different than expected, broken packaging, or no instructions.
- No screening or prescription by a licensed clinician, or no clinician to answer questions later.
- Spelling errors or wrong pharmacy addresses on the label, or a pharmacy name you suspect is fraudulent.
If you use a multi-dose vial
The FDA recommends discarding a multi-dose vial 28 days after first use even if medicine remains, using a new sterile needle and syringe for every dose, and not using any injectable GLP-1 that arrives warm [1].
Enforcement so far
On September 9, 2025 the FDA told Hims & Hers (dba Hers) that website claims for its compounded semaglutide, including "same active ingredient as Ozempic and Wegovy" and "clinically proven ingredients", were false or misleading [2]. On March 3, 2026 it announced 30 more warning letters to telehealth companies, again citing claims implying sameness with approved products, and noted that compounded drugs are also not the same as FDA-approved generics [3].
The FDA also warns against products sold "for research purposes" or "not for human consumption" containing semaglutide, tirzepatide, retatrutide, survodutide or mazdutide [1].
Quick answers
Is compounded semaglutide FDA-approved like Wegovy?
No. Compounded semaglutide is not FDA-approved, and the FDA says claims of sameness with an approved drug are a red flag [1].
Why are some compounded products cheaper?
They are not FDA-approved products and are made by pharmacies for individual prescriptions; the FDA lists prices that seem too good to be true as a warning sign [1].
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References
- [1]FDA's Concerns with Unapproved GLP-1 Drugs Used for Weight Loss (content current as of 10/01/2026). U.S. Food and Drug Administration, 2026.
- [2]Warning letter to Hims & Hers Health, Inc. dba Hers, MARCS-CMS 716825. U.S. Food and Drug Administration, 2025.
- [3]FDA Warns 30 Telehealth Companies Against Illegal Marketing of Compounded GLP-1s (March 3, 2026). U.S. Food and Drug Administration, 2026.