FDA WARNING_LETTER - GlavMed - September 19, 2017

On September 19, 2017, the FDA issued a Warning Letter to GlavMed, citing violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act) for offering unapproved new drugs and misbranded drugs for sale to U.S. consumers via multiple websites.

The FDA determined that products sold on GlavMed's websites are unapproved new drugs under sections 201(g) and 201(p) of the FD&C Act, as they are intended for disease treatment or to affect body structure/function and are not generally recognized as safe and effective. Examples include oral chloramphenicol, which has no approved applications and was previously withdrawn from the U.S. market due to serious safety concerns (e.g., fatal blood disorders, aplastic anemia) and the availability of safer alternatives. Roxithromycin, also offered, has never had FDA approval in the U.S. The introduction of these unapproved drugs into interstate commerce violates sections 301(d) and 505(a) of the FD&C Act.

Furthermore, GlavMed's websites offer prescription drugs, such as chloramphenicol and roxithromycin, without requiring a prescription, which misbrands them under section 503(b)(1) of the FD&C Act. Dispensing prescription drugs without a valid prescription violates section 301(k).