FDA WARNING_LETTER - USARxMedicine - October 13, 2020

On October 1, 2020, the FDA issued a Warning Letter to UsaRxMedicine for unlawfully selling unapproved and misbranded opioids to U.S. consumers over the internet. The FDA determined that UsaRxMedicine's network introduces opioids into interstate commerce that violate sections 301(a), 301(d), 503(b), and 505(a) of the FD&C Act [21 U.S.C. §§ 331(a), 331(d), 353(b), and 355(a)].

Specifically, products like "OL-TRAM" and "Tramadol" by Dimedics are deemed unapproved new drugs because they lack FDA approval under section 505(a) of the FD&C Act, despite being intended for medical use. These unapproved drugs pose risks as they lack safety and effectiveness assurances, potentially being contaminated, counterfeit, or having inconsistent active ingredients.

Furthermore, these drugs are misbranded under section 502(f)(1) of the FD&C Act [21 U.S.C. § 352(f)(1)] because they fail to bear adequate directions for use by a layperson. As prescription drugs, they require supervision by a licensed practitioner and cannot be safely self-administered.

UsaRxMedicine is required to immediately cease offering viol