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 “PharmaZee” on the pictured label, suggesting PharmaZee is the compounder of those drugs when in fact it is not.
Passage 2Compounded drug products are not FDA-approved. Your claims imply that your products have been FDA-approved or otherwise evaluated for safety and effectiveness when they have not.
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)