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 “Harper Meds” on the pictured label, suggesting Harper Meds is the compounder of those drugs when in fact it is not.
Passage 2“Same active ingredient as Ozempic™ & Wegovy™”
Passage 3Your website claims that the compounded drug products it offers are sourced from “FDA-licensed 503A Outsourcing Facilities.”
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)