SimpleRx, an online pharmacy, was cited for unlawfully selling unapproved and misbranded compounded drug products, specifically semaglutide and tirzepatide, by making false claims that implied their compounded formulations were equivalent to FDA-approved branded products (Ozempic and Zepbound). The company violated sections 502(a) and 502(bb) of the Federal Food, Drug, and Cosmetic Act by using misleading labeling and advertising that did not clearly distinguish their unapproved compounded drugs from approved pharmaceutical products. The FDA's August 2025 inspection of SimpleRx's website identified these violations as prohibited acts under section 301(a) of the FDCA, as compounded drugs cannot be marketed as equivalent to their FDA-approved counterparts.