FDA WARNING_LETTER - MyRXCash

The FDA issued a Warning Letter to MyRXCash after reviewing their websites, which offer unapproved new drugs and misbranded drugs for sale to U.S. consumers, violating sections 301(a), 301(d), 503(b), and 505(a) of the FD&C Act.

Specifically, the websites market "tramadol 50 mg/ml" oral solution, which is an unapproved new drug under section 201(p) and 505(a) of the FD&C Act because no FDA-approved applications are in effect for this specific formulation. While FDA-approved tramadol exists in tablet/capsule form, it carries a boxed warning due to risks like addiction, respiratory depression, and neonatal opioid withdrawal syndrome.

Furthermore, "tramadol 50 mg/ml" is a misbranded drug under section 502(f)(1) and 503(b)(1)(A) of the FD&C Act because, as a prescription product, it lacks adequate directions for layperson use and is not amenable to self-diagnosis and treatment. Its unapproved status also means it's not exempt from misbranding requirements.

The FDA emphasizes the inherent risk to consumers from unapproved and misbranded drugs, citing concerns about safety, effectiveness, contamination, and the opioid epidemic. MyRXCash is required to immediately cease marketing violative