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Semaglutide and tirzepatide are among the most searched medicines in the U.S. Our information pages for semaglutide and tirzepatide label both as “FDA-approved prescription drug (Rx only)”. This article explains what that status means for you as a consumer. It is general information, not medical advice.
Key Takeaways
- Semaglutide and tirzepatide are FDA-approved prescription medicines, not supplements.
- Semaglutide is sold as Ozempic, Wegovy and Rybelsus; tirzepatide as Mounjaro and Zepbound.
- A licensed provider must prescribe them and a licensed pharmacy must dispense them.
- The FDA has warned consumers about unapproved and counterfeit versions sold online.
What do semaglutide and tirzepatide do?
Semaglutide is a GLP-1 receptor agonist. Tirzepatide acts on two receptors, GIP and GLP-1. Both are approved by the FDA for specific uses under specific brand names, and a prescriber decides whether one is appropriate for a particular patient.
How do the brand names relate?
| Active ingredient | Brand names | Form |
|---|---|---|
| Semaglutide | Ozempic, Wegovy | Injection |
| Semaglutide | Rybelsus | Tablet |
| Tirzepatide | Mounjaro, Zepbound | Injection |
Each brand is approved for particular uses, which is why a prescriber may choose one brand over another.
What does "FDA-approved prescription drug" mean?
FDA approval means the manufacturer submitted evidence of safety and effectiveness for a specific use, and the FDA approved the product with official labeling. “Prescription only” means it can legally be dispensed only on a valid prescription from a licensed provider, through a licensed pharmacy. That is very different from a dietary supplement, which does not require FDA approval before sale.
Why not buy these medicines from websites that sell without a prescription?
The FDA has issued repeated warnings about unapproved, counterfeit and mislabeled versions of these drugs sold online, including products marketed as “research use only”. Products from unlicensed sellers may not contain what the label says. The safe route is a licensed provider and a licensed pharmacy.
Is there a supplement alternative?
No supplement is equivalent to a prescription GLP-1 medicine. Some supplements are marketed as “GLP-1 support”; our article on what GLP-1 support supplements are explains how to read those labels.
Why does our store have pages for prescription drugs?
People search for clear, factual information about these medicines. Our peptide pages give that information and state each product’s U.S. regulatory status. Prescription-only, investigational and unapproved compounds are not sold through our store.
Frequently Asked Questions
Can I buy semaglutide or tirzepatide on this website?
No. These pages are information only. Talk to a licensed healthcare provider if you are interested in a prescription treatment.
Are Ozempic and Wegovy the same drug?
Both contain semaglutide, but they are separate FDA-approved products with different labeling and approved uses.
What does Rx only mean?
It means the medicine can only be dispensed with a valid prescription from a licensed provider.
For more on regulatory labels, see our Buyer’s Guide.