RX Partners – FDA Warning Letter

The FDA issued a Warning Letter after reviewing numerous websites operated by the firm, determining they offer unapproved new drugs and misbranded drugs for sale to U.S. consumers, violating sections 301(a), 301(d), 502(a), 502(f), 503(b), and 505(a) of the FD&C Act. Products like “Generic Truvada” and “Generic Advair Diskus” are marketed as drugs intended for disease treatment or affecting body function, but lack FDA approval, making their introduction into interstate commerce illegal. These products mislead consumers and pose significant safety risks, as they bypass critical safeguards like black box warnings and licensed practitioner oversight, which are crucial for FDA-approved versions of these high-risk medications. Additionally, the firm offers “Generic Depakote” without requiring a prescription, misbranding it under section 503(b)(1)(B)(iii), and its labeling fails to provide adequate directions for use, further misbranding it under section 502(f)(1). The FDA emphasizes the inherent risks of unapproved drugs, which may be contaminated, counterfeit, or contain incorrect ingredients. The firm must immediately cease marketing violative products and respond within 10 working days with corrective actions to prevent recurrence, or face regulatory action.