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 “Genesis” on the pictured label, suggesting Genesis is the compounder of those drugs when in fact it is not.
Passage 2“Contains the same active ingredient as Ozempic® and Wegovy®”
Passage 3“Same active ingredient as Mounjaro®”
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)