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 “amie” on the pictured label, suggesting Amie is the compounder of those drugs when in fact it is not.
Passage 2“Ozempic, Mounjaro, and Wegovy contain the same active ingredients as our compounded versions (semaglutide and tirzepatide).”
Passage 3“All our treatments use FDA-approved active ingredients….”
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)