TO: CustomerService@NorthWestPharmacy.com
FROM: United States Food and Drug Administration
Center for Drug Evaluation and Research
Office of Compliance
Office of Drug Security, Integrity and Recalls
Division of Supply Chain Integrity
RE: Internet Marketing of an Unapproved and Misbranded Drug
DATE: May 24, 2012

WARNING LETTER

The United States Food and Drug Administration (FDA) reviewed your website, www.NorthWestPharmacy.com, on January 4, 2012 and has determined that your website offers products for sale in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act). More specifically, the website offers an unapproved and misbranded new drug for sale in violation of sections 502(f) and 505(a) of the FD&C Act [21 U.S.C. §§ 352(f) and 355(a)], which are prohibited acts under sections 301(a) and 301(d) of the FD&C Act [21 U.S.C. §§ 331(a) and 331(d)], respectively. We request that you immediately cease marketing violative drug products to United States consumers.

Unapproved New Drug

Alitretinoin, trade name, Toctino, is offered for sale on your website “to treat severe long-term eczema that affects the hands … for patients who have not found success using other corticosteroid treatments.” Based on this claim, Toctino appears to be a drug within the meaning of section 201(g) of the FD&C Act [21 U.S.C. §321(g)] because it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or it is intended to affect the structure or function of the body. Moreover, Toctino appears to be a new drug within the meaning of section 201 (p) of the FD&C Act [21 U.S.C. §321(p)] because it is not generally recognized as safe and effective for its labeled use. Although Toctino is approved in Canada, no approved application pursuant to section 505 of the FD&C Act [21 U.S.C. §355] is in effect for this product. Accordingly, its introduction or delivery for introduction into interstate commerce violates section 505(a) of the FD&C Act [21 U.S.C. §355(a)] and is prohibited under section 301(d) of the FD&C Act [21 U.S.C. §331(d)].

Misbranded Drug

Alitretinoin is a retinoid that is potentially dangerous when orally administered due to its teratogenicity. Because of this potential toxicity, its Canadian labeling states that it should be prescribed only by physicians knowledgeable in the use of systemic retinoids and who understand the risks of teratogenicity in females of childbearing potential. In addition, these females are required to have pregnancy tests before, at regular intervals during, and after discontinuation of alitretinoin therapy to exclude pregnancy. Because Toctino is unapproved in the United States, these safety controls are bypassed when alitretinoin is purchased over the Internet by customers in the United States without consultation with and a valid prescription from a physician.

This places American patients who use the drug at risk for adverse effects. Thus, Toctino offered for sale on your website is misbranded within the meaning of section 502(f)(1) of the FD&C Act [21 U.S.C. §321(f)(1)] in that the labeling for Toctino fails to bear adequate directions for use. The introduction or delivery for introduction into interstate commerce of a misbranded drug product is a prohibited act under section 301(a) of the FD&C Act [21 U.S.C. §331(a)].

FDA is taking action against your firm because of the inherent risk in buying unapproved and misbranded new drugs. Unapproved new drugs may not have the same assurance of safety, efficacy, and quality as drugs subject to FDA oversight, and such drugs have been found to be contaminated, counterfeit, contain varying amounts of active ingredients, or contain different ingredients altogether.

FDA- regulated drugs offer protections that include rigorous scientific standards for new drug approval, labeling review for accuracy and completeness, and manufacturing procedures and testing performed under closely controlled conditions at FDA-registered and inspected facilities.

In addition, pharmacies and wholesalers who sell or distribute prescription drugs in the U.S. are licensed by the states. Unapproved new drugs delivered to the American public may not be safe and effective.

This letter is not intended to identify all of the ways in which your activities might be in violation of law. It is your responsibility to ensure that all products marketed by your firm are in compliance with FD&C Act and its implementing regulations. You should take prompt action to correct the violations noted above. Failure to correct these violations promptly may result in FDA regulatory action, including but not limited to, seizure or injunction, without further notice.

Please notify this office in writing within 15 working days of receipt of this letter of any steps you have taken or will take to correct the noted violations and to prevent their recurrence. If the corrective action(s) cannot be completed within 15 working days, state the reason for the delay and the time within which the correction(s) will be completed. Your response should be sent to DrugSupplyChainintegrity@fda.hhs.gov.

Please direct any inquiries concerning this letter to Leigh Verbois, Acting Deputy Director for the Division of Supply Chain Integrity at the above address.

Sincerely,

/s/

Thomas Christl, Office Director (Acting)
Office of Drug Security, Integrity and Recalls
Office of Compliance