FDA WARNING_LETTER - One Stop Pharma

The FDA issued a Warning Letter to One Stop Pharma for offering unapproved and misbranded opioid products, specifically "Roxycodone" (oxycodone), for sale to U.S. consumers via websites including onestoppharma.org and onesteppharma.net. This violates sections 301(a), 301(d), 301(k), 503(b), and 505(a) of the FD&C Act.

The products are deemed "new drugs" under section 201(p) because they lack FDA approval for safety and effectiveness, violating sections 301(d) and 505(a). Despite FDA-approved oxycodone having a "black box warning" for serious risks like addiction and respiratory depression, One Stop Pharma's version lacks such warnings and approval.

Furthermore, the drugs are misbranded under section 502(f)(1) because they lack adequate directions for layperson use, as they are prescription-only drugs requiring professional supervision. Offering them without a prescription also misbrands them under section 503(b)(1) and violates section 301(k).

The FDA emphasizes the inherent risk of unapproved drugs, which may be contaminated, counterfeit, or have inconsistent active ingredients, especially amid the U.S. opioid epidemic. One Stop Pharma must immediately cease selling violative drugs and respond within 10