FDA WARNING_LETTER - buy-pharma.md - January 05, 2021

On January 28, 2021, the FDA issued a Warning Letter to www.buy-pharma.md for unlawfully selling unapproved and misbranded drugs to U.S. consumers, specifically citing observations from January 5, 2021. The website offers drug products, including azithromycin (e.g., "Generic Zithromax") and hydroxychloroquine (e.g., "Generic Plaquenil"), marketed with claims to mitigate, prevent, treat, diagnose, or cure COVID-19 and other diseases like lupus, rheumatoid arthritis, and bacterial infections.

These products are deemed unapproved new drugs under Section 505(a) of the FD&C Act [21 U.S.C. § 355(a)] because no FDA-approved applications are in effect for them, violating Sections 301(d) and 505(a). They are also misbranded under Section 502(f)(1) [21 U.S.C. § 352(f)(1)] as they lack adequate directions for use by a layperson, being prescription drugs intended for conditions not amenable to self-diagnosis. The FDA emphasizes the inherent risks of unapproved and misbranded drugs, including potential contamination, counterfeiting, and varying active ingredient amounts.

The letter demands that www.buy-pharma.md cease the sale of all