FDA WARNING_LETTER - Unitedpharmacies.md - March 12, 2020

On March 30, 2020, the FDA issued a Warning Letter to United Pharmacies (www.unitedpharmacies.md) following a March 12, 2020, review of their website. The FDA determined the company was unlawfully selling unapproved and misbranded drugs, specifically "Lopimune," "Hivus-LR" (both lopinavir + ritonavir), and "Ribasure" (ribavirin), claiming they could mitigate, prevent, treat, diagnose, or cure COVID-19.

These products are considered unapproved new drugs under section 505(a) of the FD&C Act (21 U.S.C. § 355(a)) because no approved applications are in effect for them, despite FDA-approved versions of the active ingredients existing. They are also misbranded under section 502 (21 U.S.C. § 352). The introduction of these products into interstate commerce violates sections 301(a) and (d) (21 U.S.C. § 331(a) and (d)).

The FDA cited inherent risks to consumers from unapproved drugs, including potential contamination, counterfeiting, and inconsistent active ingredient amounts. The company was ordered to immediately cease selling these unapproved and unauthorized COVID-19-related products. Within 48 hours, United Pharm