FDA WARNING_LETTER - www.uspharmacyshop.com - September 10, 2020

The FDA issued a Warning Letter to www.uspharmacyshop.com for offering unapproved and misbranded opioid products, specifically "tramadol 50 mg/ml" manufactured by "sicomed," for sale to U.S. consumers. This violates sections 301(a), 301(d), 503(b), and 505(a) of the FD&C Act.

The website's products are deemed "unapproved new drugs" under sections 201(g) and 201(p) because they are intended for disease treatment or to affect body structure/function and are not generally recognized as safe and effective, lacking FDA approval. The specific tramadol product offered is not FDA-approved, despite approved versions existing, and lacks the required boxed warning for serious risks like addiction, respiratory depression, and neonatal opioid withdrawal syndrome.

Furthermore, the drugs are "misbranded" under section 502(f)(1) because they lack adequate directions for use by a layperson. As prescription drugs, they require professional supervision for safe use, and adequate directions cannot be provided for self-treatment. The product is not exempt from misbranding requirements under 21 CFR 201.115.

The FDA demands immediate cessation of offering violative drugs for sale to U.S. consumers due to inherent risks. The company must notify the FDA within 15