FDA WARNING_LETTER - Northwest Pharmacy - June 28, 2012

On January 4, 2012, the FDA reviewed www.NorthWestPharmacy.com and found it offered unapproved and misbranded new drugs for sale, violating the Federal Food, Drug, and Cosmetic Act (FD&C Act). Specifically, Alitretinoin (Toctino) was offered to treat severe hand eczema.

Toctino is considered a "drug" and "new drug" under sections 201(g) and 201(p) of the FD&C Act, as it's intended for disease treatment and is not generally recognized as safe and effective for its labeled use. Despite Canadian approval, no FDA application under section 505 is in effect, making its interstate commerce a violation of section 505(a) and prohibited under section 301(d).

Furthermore, Toctino is misbranded under section 502(f)(1) because its labeling lacks adequate directions for use. Alitretinoin is teratogenic, requiring strict safety controls in Canada (physician oversight, pregnancy tests). Online sales to U.S. consumers bypass these controls, posing significant risks.

The FDA emphasized the inherent risks of unapproved and misbranded drugs, which may lack safety, efficacy, and quality assurances, potentially being contaminated, counterfeit, or containing incorrect ingredients. FDA-regulated drugs undergo rigorous approval, labeling, and manufacturing oversight.

NorthWest Pharmacy was