FDA WARNING_LETTER - Rx-Partners

The FDA issued a Warning Letter to Rx-Partners after reviewing its numerous websites, determining they offer unapproved new drugs and misbranded drugs for sale to U.S. consumers, violating sections 301(a), 301(d), 301(k), 503(b), and 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The letter highlights that products like "Generic Chloromycetin (chloramphenicol)" are unapproved new drugs, lacking FDA approval under section 505(a), and were previously withdrawn from the U.S. market due to serious safety concerns, including fatal blood disorders. Furthermore, the websites market misbranded drugs. These products fail to bear adequate directions for their intended uses, as required by section 502(f)(1) and 21 CFR 201.5, because they are prescription drugs not suitable for self-treatment. This constitutes the introduction of misbranded drugs into interstate commerce. Additionally, Rx-Partners offers prescription drugs, such as chloramphenicol and Levaquin (levofloxacin), without requiring a valid prescription, which misbrands the products under section 503(b)(1) and violates section 301(k) by dispensing them while held for sale. This practice jeopardizes patient safety due to the significant risks associated with these medications. FDA demands immediate cessation of marketing violative drug products and a written response within 10 working days detailing corrective actions to prevent recurrence, warning of potential regulatory actions like seizure or injunction.