globalpharmacystores.com – FDA Warning Letter, Sep 10, 2020

The FDA issued a Warning Letter to www.globalpharmacystores.com for offering misbranded and unapproved new opioid drugs for sale to U.S. consumers via its website, violating the Federal Food, Drug, and Cosmetic Act (FD&C Act). The letter, dated September 10, 2020, highlights the severe public health crisis posed by opioid addiction and the risks associated with unapproved and misbranded drugs, which lack assurance of safety and effectiveness. Specifically, the website introduces unapproved new drugs into interstate commerce, violating sections 301(d) and 505(a) of the FD&C Act, as no approved applications are in effect for these products, such as "OL-TRAM" (tramadol). Furthermore, these drugs are misbranded under section 502(f)(1) and 301(a) of the FD&C Act because their labeling fails to bear adequate directions for use, as they are prescription drugs not amenable to self-diagnosis and treatment. The FDA emphasized that unapproved drugs may be contaminated, counterfeit, or contain incorrect active ingredients. The FDA requires www.globalpharmacystores.com to immediately cease offering violative drugs for sale and to notify the agency in writing within 15 working days of the steps taken to correct these violations and prevent recurrence. Failure to comply may result in further regulatory action, including seizure or injunction. The letter underscores the firm's responsibility to ensure all products comply with the FD&C Act and its regulations.