Selected passages from the FDA letter
Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.
Passage 1The compounded tirzepatide products displayed on your website feature NativeMed’s logo on the pictured label, suggesting NativeMed is the compounder of those drugs when in fact it is not.
Passage 2“The same active ingredient in Ozempic® and Wegovy®”
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)