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 “Momentum Health” on the pictured label, suggesting Momentum Health is the compounder of those drugs when in fact it is not.
Passage 2Compounded drug products are not FDA-approved. Your claims represent that the compounded drug products you offer have been FDA-approved or otherwise evaluated for safety and effectiveness when they have not.
Passage 3Your website claims “Compounded Semaglutide refers to a medication meticulously formulated [sic] FDA-licensed compounding facility….” Compounding facilities, including pharmacies and outsourcing facilities, are not “FDA-approved” or “FDA-licensed” entities.
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)