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

The FDA issued a Warning Letter to skylimitpharmacy.com for offering unapproved and misbranded opioid products, specifically "Roxycodone" (oxycodone) by Actavis/Amide, for sale to U.S. consumers. This violates sections 301(a), 301(d), 301(k), 503(b), and 505(a) of the FD&C Act.

The "Roxycodone" is an unapproved new drug because no FDA applications are in effect for it, violating sections 301(d) and 505(a). The website's use of an FDA logo on the product image is misleading, implying approval. FDA-approved oxycodone carries a "black box warning" for severe risks like addiction, respiratory depression, and neonatal opioid withdrawal syndrome, which the unapproved product lacks.

Furthermore, the drug is misbranded under section 502(f)(1) as it lacks adequate directions for use by a layperson, being a prescription drug. Offering it without requiring a prescription also misbrands the drug under section 503(b)(1) and violates section 301(k).

The FDA demands immediate cessation of violative drug sales to U.S. consumers. The company must notify the FDA within 15 working days of corrective actions taken or planned, including preventing recurrence of these and similar violations.