FDA WARNING_LETTER - www.directpharmashop.net - November 21, 2023

On November 8, 2023, the FDA issued a Warning Letter to www.directpharmashop.net for introducing misbranded and unapproved new drugs into interstate commerce, violating sections 301(a), 301(d), 301(k), 503(b), and 505(a) of the FD&C Act.

The website offers unapproved new drugs, specifically aripiprazole ("Abilify 15mg" by Bristol-Myers Squibb), which lacks FDA approval under section 505(a) of the FD&C Act. Despite FDA-approved versions existing, the product sold by directpharmashop.net is unapproved and intended for conditions requiring prescription and bearing serious warnings.

Additionally, the website sells misbranded drugs. Aripiprazole and quetiapine ("Seroquel 200mg") are prescription drugs requiring a licensed practitioner's supervision due to their toxicity and potential for harmful effects. The website offers these without requiring a prescription, violating section 503(b)(1) and 301(k) of the FD&C Act, as their labeling lacks adequate directions for layperson use.

The FDA demands www.directpharmashop.net cease selling all unapproved and misbranded drugs to U.S. consumers to protect public safety. The company must respond in writing within 15 working days