FDA WARNING_LETTER - Bellevue Pharmacy Solution

The FDA issued a Warning Letter to Bellevue Pharmacy Solutions based on its website and advertisements, indicating the firm compounds and distributes drugs, including hyaluronidase, progesterone, diphenhydramine, dimenhydrinate, folic acid, pyridoxine, thiamine, and EDTA. The firm also compounds products containing polidocanol, cantharidin, estriol, and domperidone, which are not components of any FDA-approved drug.

The FDA considers compounded drugs "new drugs" under the FDCA, requiring FDA approval for interstate commerce. While FDA historically exercises enforcement discretion for traditional compounding, Bellevue Pharmacy Solutions' activities raise concerns.

Specifically, the firm compounds copies or near copies of FDA-approved, commercially available drugs (e.g., Hyaluronidase, Progesterone, Diphenhydramine) without apparent patient-specific medical need, for which the FDA will not exercise enforcement discretion.

Furthermore, the firm compounds products using active ingredients not found in FDA-approved drugs, such as polidocanol, cantharidin, estriol, and potentially domperidone. The FDA expresses public health concerns regarding these, citing adverse events for polidocanol and domperidone (e.g., cardiac arrhythmias, sudden death, and unapproved use for lactation). These products are compounded without FDA-sanctioned Investigational New Drug (IND) applications.

These compounded products are deemed unapproved new drugs, violating Sections 201(g),