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, tirzepatide, and liraglutide products displayed on your website identify “Zappy” on the pictured label, suggesting Zappy is the compounder of those drugs when in fact it is not.
Passage 2“Semaglutide (Active Pharmaceutical Ingredient in Wegovy®)See Wegovy FDA Information” [sic]
Passage 3“Liraglutide (Active Pharmaceutical Ingredient in Saxenda®)See Saxenda FDA Information” [sic]
Passage 4“Tirzepatide (Active Pharmaceutical Ingredient in Zepbound®)See Zepbound FDA Information” [sic]
Passage 5“a proven medication”
Passage 6“Clinically studied and shown to deliver powerful results when combined with healthy habits.”
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)