FDA WARNING_LETTER - PharmCash

The FDA issued a Warning Letter to PharmCash on September 19, 2017, for unlawfully selling unapproved new drugs and misbranded drugs to U.S. consumers via multiple websites. The review found products, including oral chloramphenicol (Chloromycetin) and Levaquin (levofloxacin), are unapproved new drugs under sections 201(g) and 201(p) of the FD&C Act, lacking FDA approval and general recognition of safety and effectiveness. Their introduction into interstate commerce violates sections 301(d) and 505(a).

Additionally, these products are misbranded. They fail to bear adequate directions for use as prescription drugs not amenable to layperson self-treatment, violating section 502(f)(1) and 301(a). PharmCash also offers prescription drugs for sale without requiring a valid prescription, jeopardizing patient safety and misbranding the drugs under sections 503(b)(1) and 301(k). Notably, chloramphenicol was previously withdrawn from the U.S. market due to serious safety concerns like fatal blood disorders.

PharmCash must immediately cease marketing these violative drug products. A written response detailing corrective actions and recurrence prevention is required within 10 working days. Non-compliance could result in FDA regulatory actions, including seizure or injunction, highlighting the significant risks to consumers from unapproved and misbranded drugs.