FDA WARNING_LETTER - Saint John's Medical Plaza Pharmacy

On January 7, 2008, the FDA issued a Warning Letter to Saint John's Medical Plaza Pharmacy, specifically to Ms. Nancy Mavadat, following a review of the firm's website, www.saintjohnpharmacy.com. The letter identified multiple significant violations of the Federal Food, Drug, and Cosmetic Act (FDCA). 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 its website. These claims included unsubstantiated efficacy benefits, such as treating heart disease, Alzheimer's, and improving mood, as well as unsubstantiated assertions that the drugs were "bio-identical." The FDA stated it was unaware of substantial evidence to support these claims. Secondly, the pharmacy was found to be compounding hormone therapy drugs containing estriol without an FDA-approved new drug application or an FDA-sanctioned investigational new drug (IND) application. This constitutes a violation of Section 505 of the FDCA, rendering these estriol-containing products unapproved new drugs. Finally, these estriol drugs were also cited as misbranded under Section 502(f)(1) of the FDCA because their labeling failed to bear adequate directions for use. The FDA requires the firm to take prompt corrective action within fifteen working days, providing a written response detailing steps taken to address and prevent recurrence of these violations. Failure to comply could lead to legal actions like seizure or injunction, and impact federal contract eligibility.