FDA WARNING_LETTER - Worldwide Drug Store - September 19, 2017

On September 19, 2017, the FDA issued a Warning Letter to Worldwide Drug Store for illegally selling unapproved new drugs and misbranded drugs to U.S. consumers via numerous websites. The FDA's review found violations of sections 301(a), 301(d), 301(k), 503(b), and 505(a) of the FD&C Act.

Specifically, the company offered unapproved new drugs like oral chloramphenicol and roxithromycin. Oral chloramphenicol, despite claims of treating serious infections, has no FDA-approved applications and was previously withdrawn due to severe risks, including fatal blood disorders, as indicated by a "black box warning." Roxithromycin, marketed for various infections, also lacks any FDA approval in the U.S.

Furthermore, Worldwide Drug Store sold prescription drugs, including chloramphenicol and roxithromycin, without requiring a prescription, violating section 503(b)(1) of the FD&C Act. This practice misbrands the drugs under section 301(k) and 502(f)(1) because they lack adequate directions for layperson use and require professional supervision due to their toxicity and potential for harm.

The FDA emphasized the inherent risk to consumers from unapproved and misbranded drugs, which may be contaminated, counterfeit, or contain incorrect ingredients. Worldwide