FDA WARNING_LETTER - rxshopmd.com - December 13, 2021

On February 15, 2022, the FDA issued a Warning Letter to www.rxshopmd.com following a December 13, 2021, review of their website. The FDA found the website was unlawfully selling unapproved and misbranded drugs to U.S. consumers, including products claiming to mitigate, prevent, treat, diagnose, or cure COVID-19 and other diseases like HIV.

Specifically, the website offered "Hivus-LR (Lopinavir + Ritonavir 200/50 mg)" by Aurobindo Pharma Ltd., marketed with claims of COVID-19 treatment, despite no FDA approval for this use or for the specific product. This constitutes the sale of unapproved new drugs, violating sections 505(a), 301(d), and 301(a) of the FD&C Act [21 U.S.C. §§ 355(a), 331(d), 331(a)].

Furthermore, the drugs were deemed misbranded under section 502(f)(1) [21 U.S.C. § 352(f)(1)] due to lacking adequate directions for layperson use, as they are prescription drugs requiring professional supervision. Dispensing these prescription drugs without a prescription also violates section 301(k) [21 U.S.