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 products displayed on your website identify “RoenRx” on the pictured label, suggesting RoenRx is the compounder of those drugs when in fact it is not.
Passage 2“Semaglutide is the active ingredient in FDA-approved medications like Wegovy and Ozempic….”
Passage 3“RoenRx also offers semaglutide, the active ingredient in Wegovy® and Ozempic®….”
Passage 4“Get affordable semaglutide (main ingredient in Ozempic® & Wegovy®) at an affordable price.”
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)