FDA WARNING_LETTER - Pacifica Pharmacy

On January 7, 2007, the FDA issued a Warning Letter to Pacifica Pharmacy, citing violations related to their compounded hormone therapy drugs. The FDA's review of the firm's website, www.pacificapharmacy.com, revealed several issues.

Firstly, the firm's compounded hormone therapy drugs were deemed misbranded under Section 502(a) of the FDCA due to false and misleading claims on their website. These unsubstantiated claims included "Protection against heart disease," "Reduced risk of breast cancer," and "Fewer side effects versus synthetic derivatives," suggesting superiority without adequate scientific evidence. Additionally, the claim that their drugs are "bio-identical" was found to be unsupported by substantial evidence.

Secondly, the firm was cited for compounding a hormone therapy drug containing estriol without an FDA-approved new drug application or an FDA-sanctioned investigational new drug application, violating Section 505 of the FDCA. The FDA considers these estriol-containing products unapproved new drugs because estriol is not a component of an FDA-approved drug.

Thirdly, the estriol drugs were also found to be misbranded under Section 502(f)(1) of the FDCA because their labeling lacked adequate directions for use and they were not exempt from this requirement.

Pacifica Pharmacy was instructed to take prompt action to correct these violations and notify the FDA in writing within fifteen working days of