FDA WARNING_LETTER - Village Compounding Pharmacy

The FDA issued a Warning Letter to Village Compounding Pharmacy after reviewing their website, www.villagecompounding.com, identifying several violations related to their compounded hormone therapy drugs.

The firm's compounded hormone therapy drugs are deemed misbranded under Section 502(a) of the FDCA due to false and misleading claims. The website presented unsubstantiated efficacy claims for "BIO-IDENTICAL HRT" in treating conditions like fibrocystic breasts, depression, and heart disease, and for "ESTROGENS" improving memory, sleep, and mood. Additionally, unsubstantiated superiority claims suggested their compounded drugs were better than synthetic or animal hormones, and unsubstantiated "bio-identical" claims implied their products were natural or identical to body-produced hormones. The FDA stated it is unaware of substantial evidence (adequate and well-controlled clinical investigations) to support these claims.

Furthermore, the firm is compounding hormone therapy drugs containing estriol, which are considered unapproved new drugs under Section 505 of the FDCA. Estriol is not a component of an FDA-approved drug, and the firm lacks an FDA-sanctioned investigational new drug application. These estriol-containing drugs are also misbranded under Section 502(f)(1) of the FDCA because their labeling fails to bear adequate directions for use and they are not exempt from this requirement.

The FDA requires the firm to take prompt action to correct these