Inhousepharmacy.vu – FDA Warning Letter, May 10, 2022

The FDA issued a Warning Letter to www.inhousepharmacy.vu on May 4, 2022, for unlawfully selling unapproved domperidone drug products to U.S. consumers over the internet. The FDA's review of the website revealed the introduction of domperidone drug products, such as "Vomistop (Domperidone 10mg) 500 Tablets/Pack," into interstate commerce.

Domperidone is not a legally marketed human drug in the U.S. and is not approved for sale. The FDA highlights serious risks associated with domperidone, including cardiac arrhythmias, cardiac arrest, and sudden death, with higher blood levels increasing these risks, especially with concurrent use of certain drugs like erythromycin.

The sale of these products violates sections 301(d) and 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. §§331(d) and 355(a)], as they are unapproved new drugs lacking FDA approval. Unapproved drugs lack assurances of safety and effectiveness and may be contaminated, counterfeit, or contain incorrect ingredients.

The FDA requires www.inhousepharmacy.vu to cease offering any unapproved drugs for sale to U.S. consumers. A written response within 15 working days is required, detailing specific steps taken to address violations and prevent