FDA WARNING_LETTER - www.alphamedstore.com - October 10, 2023

The FDA issued a Warning Letter to www.alphamedstore.com on September 29, 2023, for introducing unapproved and misbranded new drugs, specifically opioid products, into interstate commerce, violating sections 301(a), 301(d), 301(k), 503(b), and 505(a) of the FD&C Act.

The website offers "Zomorph capsules 10mg sustained release morphine sulfate" by Ethypharm, categorized as "Pain Relief Medicine." This product is an unapproved new drug under sections 201(g) and 201(p) of the FD&C Act, as no FDA-approved applications exist for it. The FDA emphasizes the severe risks of unapproved opioids, including contamination, counterfeiting, and varying active ingredient amounts, especially given the opioid epidemic.

Furthermore, the product is misbranded under section 502(f)(1) because its labeling lacks adequate directions for use by a layperson, as it is a prescription drug requiring professional supervision. Dispensing it without a prescription also violates sections 503(b)(1) and 301(k) of the FD&C Act.

Alphamedstore.com is required to cease selling all unapproved and misbranded drugs to U.S. consumers. They must respond in writing within 15 working days