Selected passages from the FDA letter
Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.
Passage 1The compounded semaglutide and tirzepatide products displayed on your website identify “AM Rx” on the pictured label, suggesting AM RX is the compounder of those drugs when in fact it is not.
Passage 2The following claims concerning compounded semaglutide products appear on your website: - “AM Rx also offers semaglutide, the active ingredient in Ozempic® and Wegovy®….” - “Semaglutide is the active ingredient in FDA-approved medications like Wegovy and Ozempic….” - “Get affordable semaglutide (main ingredient in Ozempic® & Wegovy®) at an affordable price.” Compounded drug products are not FDA-approved. Your claims represent that the compounded drug products you offer have been FDA-approved or otherwise evaluated for safety and effectiveness when they have not.
Citations in the original letter
As cited in this historical letter, not a statement of current regulatory requirements.
- 21 CFR 201.1(h)(2)
- 21 CFR 201.1(a)