Selected passages from the FDA letter
Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.
Passage 1The following claims concerning compounded tirzepatide products appear on your website: - “FDA-Approved Active” - “eDrugstore guarantees that all Tirzepatide medications are genuine, FDA-approved formulations for maximum efficacy and safety.” - “Tirzepatide (Zepbound)….” Compounded drug products are not FDA-approved. Your claims imply that your products are the same as an FDA-approved product when they are not. As a result, these claims are false or misleading and your products are therefore misbranded under sections 502(a) and 502(bb) of the FDCA [21 U.S.C. §§ 352(a) and 3