FDA WARNING_LETTER - greenrxpharmacy.com - September 10, 2020

On August 31, 2020, the FDA issued a Warning Letter to www.greenrxpharmacy.com for offering unapproved new drugs and misbranded opioids for sale, violating the FD&C Act. The website introduces into interstate commerce opioids, specifically "TOP DOL" (Tramadol), which are unapproved new drugs under sections 301(d) and 505(a) of the FD&C Act. These products lack FDA approval, meaning their safety and effectiveness are not assured, posing risks like contamination, counterfeiting, or incorrect active ingredient amounts.

Furthermore, the products are misbranded under sections 301(a) and 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 FDA emphasizes the severe public health crisis of opioid addiction and abuse, highlighting the significant risks posed by easily accessible online opioids.

The FDA demands immediate cessation of offering violative drugs to U.S. consumers. The company must 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.