Pharmempire – FDA Warning Letter

The FDA issued a Warning Letter to Pharmempire on September 19, 2017, for unlawfully selling unapproved and misbranded drug products to U.S. consumers via numerous websites. The FDA's review determined that Pharmempire's websites offer products in violation of sections 301(a), 301(d), 301(k), 503(b), and 505(a) of the FD&C Act.

Specifically, the company is marketing unapproved new drugs, such as oral chloramphenicol and roxithromycin. Oral chloramphenicol was previously withdrawn from the U.S. market due to safety concerns, including serious and sometimes fatal blood disorders, and roxithromycin has never been approved in the U.S. These products are considered new drugs under section 201(p) of the FD&C Act and lack FDA approval, violating sections 301(d) and 505(a).

Furthermore, Pharmempire is selling misbranded prescription drugs, including chloramphenicol, roxithromycin, and Keflex (cephalexin), without requiring a prescription. This violates section 503(b)(1) of the FD&C Act, as these drugs require professional supervision due to their toxicity and potential for harm. Dispensing prescription drugs without a valid prescription misbrands them under section 301