FDA WARNING_LETTER - Murray Avenue Apothecary

The FDA issued a Warning Letter to Murray Avenue Apothecary based on a review of their website, www.murrayavenuerx.com. The letter identifies several violations related to their compounded hormone therapy drugs.

Firstly, the firm's compounded hormone therapy drugs are deemed misbranded under Section 502(a) of the FDCA due to false and misleading claims on their website. These include unsubstantiated efficacy claims such as "Reduce risk of Heart Disease," "Reduce risk of... breast cancers," and "Prevention of Alzheimer Disease and Senility." Additionally, the website makes unsubstantiated superiority claims, stating "Less unwanted side effects than synthetics" and "These plant-derived bio-identical hormones are almost entirely without the side effects of the synthetic or semi-synthetic HRT drugs commonly prescribed." The claim that their drugs are "bio-identical" is also cited as unsubstantiated, implying a natural or body-identical nature without supporting evidence.

Secondly, the firm is compounding a hormone therapy drug containing estriol, which is considered an unapproved new drug 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 (IND). This violates Section 505(a) of the FDCA, as these products are not generally recognized as safe and effective and lack FDA approval.

Thirdly, the estriol