FDA WARNING_LETTER - Azmedicinalshop.com - April 02, 2019

On March 27, 2019, the FDA issued a Warning Letter to Az Medicinal Shop for unlawfully selling unapproved and misbranded opioids to U.S. consumers via Azmedicinalshop.com. The FDA determined that the website introduces opioids into interstate commerce that violate sections 301(a), 301(d), 503(b), and 505(a) of the FD&C Act.

Specifically, products like "Tramajak-100" (tramadol) are considered unapproved new drugs because no FDA applications are in effect for them, violating sections 301(d) and 505(a). These unapproved drugs lack assurance of safety and effectiveness, posing risks like contamination or incorrect active ingredient amounts.

Furthermore, these drugs are misbranded under section 502(f)(1) because they lack adequate directions for use by a layperson, as they are prescription drugs requiring professional supervision. Since they are not FDA-approved, they are not exempt from this requirement, violating section 301(a).

The FDA emphasized the heightened concern due to the opioid epidemic and the potential for abuse and dependency. Az Medicinal Shop is required to immediately cease offering violative drugs for sale and notify the FDA within 15 working days of steps taken to correct violations and prevent recurrence. Failure to comply may result in regulatory actions like seizure or injunction.