pharmacygeoff.md – FDA Warning Letter, Mar 22, 2021

On April 15, 2021, the FDA issued a Warning Letter to www.pharmacygeoff.md after reviewing their website on March 22, 2021. The FDA observed the website offering drug products for sale in the U.S. intended to mitigate, prevent, treat, diagnose, or cure COVID-19 and other diseases like lupus, rheumatoid arthritis, malaria, HIV, and hepatitis C.

The identified violations include the sale of unapproved new drugs and misbranded drugs, violating sections 505(a), 502, 301(a), 301(d), and 301(k) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). Specific unapproved drugs cited include "Plaquenil (Hydroxychloroquine Sulfate)" manufactured by Sanofi, "Lariago-DS (Chloroquine)," "Hivus-LR (Lopinavir/Ritonavir)," "Lopimune (Lopinavir/Ritonavir)," "Ribasure (Ribavirin)," and "Dexona (Dexamethasone)." These products are unapproved for their labeled uses, especially concerning COVID-19, and lack FDA-approved applications.

The drugs are also misbranded because they lack adequate directions for use by a layperson and are prescription drugs offered without requiring a prescription, jeopardizing patient safety. The FDA emphasized the inherent