This distinction matters, and it is often unclear to patients. FDA approves specific manufactured products after reviewing their evidence and manufacturing. Compounded preparations do not go through that review. They are not generics, and they are not equivalent to the approved product.
FDA has publicly raised concerns about unapproved GLP-1 products marketed for weight loss, including dosing errors, use of salt forms that are different substances from the approved active ingredient, and products from sources outside the regulated supply chain.
Compounding has legitimate uses under specific conditions. What matters is that 'compounded semaglutide' is not FDA-approved, and you deserve to have that distinction stated plainly before you decide anything.
Risks and limitations
- Compounded products are not reviewed by FDA for safety, effectiveness or quality before marketing.
- Salt forms and other variants are not the same as the approved active ingredient.
- Dosing errors have been reported with unapproved products and devices.
- Sourcing outside the regulated supply chain carries additional risk.
- This answer describes regulatory status only and does not state what MMI does or does not dispense.