Inhousepharmacy Selling Illegal Unapproved Drugs: FDA

FDA says its review of a Web site maintained by inhousepharmacy.vu indicates the site introduces into interstate commerce domperidone drug products that are unapproved new drugs. A 5/4 Warning Letter says domperidone is not currently a legally marketed human drug and is not approved for sale in the U.S.

“There are serious risks associated with domperidone,” the letter says, “including cardiac arrhythmias, cardiac arrest, and sudden death. These risks are related to the blood level of domperidone, and higher levels in the blood are associated with higher risks of these events…. The easy availability of domperidone via the Internet poses significant risks to U.S. consumers.”

Inhousepharmacy was told to take prompt action to address violations of the Federal Food, Drug, and Cosmetic Act and to respond with a list of steps it has taken to address the violations and prevent their recurrence, with documentation of each step and a schedule for completing the corrections.