FDA WARNING_LETTER - Pharmacy Compounding Specialties

The FDA issued a Warning Letter to Pharmacy Compounding Specialties, Mr. James Porter, Owner, following a review of their website, www.pharmacyspecialties.com. The letter identifies several violations of the Federal Food, Drug, and Cosmetic Act (FDCA).

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 (e.g., "Protection against fibrocystic breast disease," "Acts as a natural antidepressant"), unsubstantiated superiority claims suggesting their natural progesterone is superior to synthetic progestins, and unsubstantiated "bio-identical" claims implying their products are natural or identical to body hormones. The FDA states it is unaware of substantial evidence (adequate and well-controlled clinical investigations) to support these claims.

Secondly, the firm is compounding hormone therapy drugs containing estriol without an FDA-approved new drug application or an FDA-sanctioned investigational new drug application, violating Section 505 of the FDCA. Estriol is not a component of an FDA-approved drug. These estriol-containing products are considered unapproved new drugs.

Thirdly, the estriol drugs are also misbranded under Section 502(f)(1) of the FDCA because their labeling lacks adequate directions for use and they are not exempt from this requirement as unapproved new