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 “Newman Clinic” on the pictured label, suggesting Newman Clinic is the compounder of those drugs when in fact it is not.
Passage 2“Same Ingredient as Ozempic® and Wegovy®”
Passage 3“Same Ingredient as Mounjaro® and Zepbound®”
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)