FDA WARNING_LETTER - rx2go.com - January 05, 2021

On January 28, 2021, the FDA issued a Warning Letter to www.rx2go.com following a January 5, 2021, review of their website. The FDA found that the website was offering unapproved and misbranded drug products for sale to U.S. consumers, including those claiming to mitigate, prevent, treat, diagnose, or cure COVID-19, lupus, rheumatoid arthritis, and malaria.

Specifically, the website offered "hydroxychloroquine sulfate (Generic Plaquenil)" and "Signaquine-200" manufactured by Signature. 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. The website misleadingly described these products as "FDA-approved," implying FDA approval for the specific versions sold, despite FDA-approved hydroxychloroquine being prescription-only and not approved for COVID-19.

Furthermore, these drugs are misbranded under section 502(f)(1) of the FD&C Act [21 U.S.C. § 352(f)(1)] as they lack adequate directions for use by a layperson, being prescription drugs intended for conditions requiring professional supervision. The introduction of these products into interstate commerce violates sections 301(a