Nova Vascular LLC dba NOVARX

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

The compounded semaglutide and tirzepatide products displayed on your website identify “NOVA RX” on the pictured label, suggesting NOVARX is the compounder of those drugs when in fact it is not.

Passage 2

The following claims concerning compounded semaglutide products appear on your website: - “…access to the same active ingredient found in Ozempic.” Compounded 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 3

Your website claims that the compounded drug products it offers are sourced from “FDA Approved Pharmacies.” Compounding facilities, including pharmacies and outsourcing facilities, are not “FDA-approved” or “FDA-licensed” entities. The FD&C Act does not establish an “FDA-approved” or “FDA-licensed” designation for pharmacies or outsourcing facilities.