Best Price Rx – FDA Warning Letter, Jan 31, 2012

On January 31, 2012, the FDA reviewed www.bestpricerx.com and found it offered unapproved and misbranded new drugs, violating the Federal Food, Drug, and Cosmetic Act (FD&C Act). Specifically, Alitretinoin (Toctino) was offered for sale.

Toctino is an unapproved new drug under sections 201(g) and 201(p) of the FD&C Act, as it is not generally recognized as safe and effective for its labeled use in the U.S., despite Canadian approval. Its introduction into interstate commerce violates section 505(a) and is prohibited under section 301(d).

Furthermore, Toctino is misbranded under section 502(f)(1) because its labeling lacks adequate directions for use. Alitretinoin is a teratogenic retinoid, requiring strict safety controls (physician oversight, pregnancy testing) in Canada. Online sales to U.S. consumers bypass these controls, posing significant health risks. The introduction of misbranded drugs is prohibited under section 301(a).

The FDA emphasized the inherent risks of unapproved drugs, including potential contamination, counterfeiting, and variable active ingredient amounts, contrasting them with FDA-regulated drugs' rigorous safety, efficacy, and quality assurances.

The firm was instructed to immediately cease marketing violative drug products to U