FDA WARNING_LETTER - Panorama Compounding Pharmacy

The FDA issued a Warning Letter to Panorama Compounding Pharmacy, Mr. Earl Broidy, Owner, on January 7, 2008, following a review of their website, www.uniquerx.com. The letter identifies several violations of the Federal Food, Drug, and Cosmetic Act (FDCA).

The firm's compounded hormone therapy drugs are deemed misbranded under Section 502(a) of the FDCA [21 USC § 352(a)] due to false and misleading claims on their website. Specifically, the website made unsubstantiated efficacy claims (e.g., reducing risk of heart disease, Alzheimer's), unsubstantiated superiority claims over synthetic hormones, and unsubstantiated "bio-identical" claims, all lacking substantial evidence from adequate and well-controlled clinical investigations.

Additionally, the firm compounds hormone therapy drugs containing estriol, which are considered unapproved new drugs under Section 505 of the FDCA (21 USC § 355). Estriol is not a component of an FDA-approved drug, and the firm lacks an FDA-sanctioned investigational new drug application (IND). These estriol-containing drugs are also misbranded under Section 502(f)(1) of the FDCA [21 U.S.C. § 352(f)(1)] because their labeling fails to bear adequate directions for use and they are