What is a compounded medication?
A compounded medication is mixed by a pharmacy for a patient instead of made by the drug's manufacturer. Compounded semaglutide and tirzepatide are not FDA-approved and are not Wegovy, Ozempic, Zepbound or Mounjaro.
What the FDA says
The FDA does not review compounded drugs for safety, effectiveness or quality before they are sold. It has received reports of harm tied to compounded GLP-1s, including dosing errors, and it has warned about products that use salt forms of semaglutide, which are a different active ingredient.
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Why it is still legal
Section 503A and 503B of federal law let pharmacies compound drugs. While semaglutide and tirzepatide were in shortage, compounders could make copies. With both off the list, a compounder may make a version that differs for a documented patient need, such as a different dose or an added ingredient.
What it means for the price
Compounded GLP-1s are the lowest cash prices on the chart. The chart labels every compounded row so it is never read as the brand-name drug.
Questions
Is compounded semaglutide the same as Wegovy?
No. It is made by a compounding pharmacy, is not FDA-approved and may differ from Wegovy in form, strength and added ingredients.
Is compounded tirzepatide legal?
Pharmacies may compound under sections 503A and 503B. Since tirzepatide left the shortage list they may not make plain copies of Zepbound or Mounjaro, so sellers offer personalized formulations.
Sources
- FDA, Compounding and the FDA: questions and answers
- FDA, Concerns with unapproved GLP-1 drugs used for weight loss
Prices on GLP Chart are read from each program's own pricing page. How: how we check prices. Every program's price this month: the GLP-1 price index.