globalpharmacyplus.com – FDA Warning Letter, Jan 3, 2023

The FDA issued a Warning Letter to www.globalpharmacyplus.com on December 27, 2022, for unlawfully selling unapproved and misbranded drugs to U.S. consumers over the Internet. The FDA observed the website introducing drugs into interstate commerce in violation of sections 301(a), 301(d), and 505(a) of the FD&C Act. This includes products claiming to mitigate, prevent, treat, diagnose, or cure COVID-19, as well as drugs subject to Risk Evaluation and Mitigation Strategy (REMS) programs and Narrow Therapeutic Index (NTI) drugs, such as Molnunat 200 (molnupiravir), CellCept 500mg (mycophenolate mofetil), and Tacrolimus Capsules Tacrograf – 0.5 (tacrolimus). These drugs are considered unapproved new drugs because no FDA applications are in effect for them. Additionally, the drugs are misbranded under section 502(f)(1) for failing to bear adequate directions for use and under section 502(f)(2) for lacking adequate warnings against dangerous use, dosage, or administration, thereby bypassing critical safety measures. The FDA emphasized the inherent risks of purchasing such products, including potential contamination, counterfeiting, and varying active ingredients. The firm is required to cease offering all unapproved or misbranded drugs for sale to U.S. consumers and respond in writing within 15 working days, detailing corrective actions and prevention measures. Failure to comply may result in legal action, including seizure and injunction, and notification to foreign regulatory officials.