Inspections, Compliance, Enforcement, and Criminal Investigations
Sun Drug Store 2/11/13
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
Silver Spring, MD 20993
TO: William Coleman
Edifacio Center 6510
P.O. Box 6-510
El Dorado, Panama City
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 Unapproved and Misbranded Drugs
DATE: February 11, 2013
The United States Food and Drug Administration (FDA) recently reviewed your website “http://www.SunDrugStore.com” 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, your website offers unapproved and misbranded new drugs for sale in violation of sections 502(a), 502(f)(1), 503(b)(1), and 505(a) of the FD&C Act [21 U.S.C. §§ 352(a), 352(f), 353(b), and 355(a)]. Introduction of such products into interstate commerce, including importation into the United States, is prohibited under sections 301(a) and 301(d) of the Act [21 U.S.C. §§ 331(a) and 331(d)]. We request that you immediately cease marketing violative drug products to United States consumers.
Unapproved New Drugs
Your firm offers for sale through your website “Generic Tamiflu.” Tamiflu is a proprietary name of an FDA-approved drug, oseltamivir phosphate, well known for its intended use to treat disease (influenza).
The oseltamivir phosphate you offer for sale through your website is 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. This product is also a new drug as defined by 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 the labeled uses. No approved applications pursuant to section 505 of the FD&C Act [21 U.S.C. § 355] are in effect for a generic Tamiflu. Accordingly, the introduction or delivery for introduction of this product into interstate commerce violates section 505(a) of the FD&C Act [21 U.S.C. § 355(a)], which is prohibited under section 301(d) of the FD&C Act [21 U.S.C. § 331(d)].
These drugs are misbranded in several different ways: Your website offers prescription drugs for sale without requiring that the drugs be dispensed only upon a valid prescription from a practitioner licensed by law to administer such drugs. Your website offers that "if you do not have a prescription, and in order to make your shopping experience hassle free, our qualified onstaff physician will issue a prescription for each order so we can legally fill and ship your order." We do not consider that the issuance of a prescription by your "on-staff physician" to a patient that your physician has not examined fulfills the requirement that a prescription drug be dispensed only upon a valid prescription. Therefore, the drugs are misbranded under section 503(b)(1) of the FD&C Act [21 U.S.C. § 353(b)(1)]. If Tamiflu or its active ingredient (oseltamivir phosphate) is not taken under close supervision of a healthcare professional and pharmacist, it can be a potentially dangerous prescription drug.
These drugs are misbranded pursuant to section 502(a) of the FD&C Act [21 U.S.C. 352(a)] because their labeling is false or misleading. Your firm’s website and promotional labeling for this product misleads the consumer to believe that the product they are purchasing is an FDA approved drug product.
Additionally, because the above mentioned drug is intended for the treatment of conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners, adequate directions cannot be written for them so that a layman can use these products safely for the intended uses. Consequently, the labeling fails to bear adequate directions for the intended uses, causing them to be misbranded under 502(f)(1) of the FD&C Act [21 U.S.C. § 352(f)(1)]. Because “generic Tamiflu” offered for sale on your website lacks a required approved application, it is not exempt from the requirements of section 502(f)(1) of the FD&C Act [21 U.S.C. § 352(f)(1)] as described in Title 21 of the Code of Federal Regulations (21 CFR) § 201.115. 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 this action against your firm because of the inherent risk in buying unapproved and misbranded new drugs. Unapproved new drugs from unregulated sources do not have the same assurance of safety and effectiveness as those 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.
This letter is not intended to identify all 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 the 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 regulatory action, including but not limited to, seizure and/or injunction without further notice.
Please notify this office 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 days, state the reason for the delay and the time within which the correction(s) will be completed. Your response and any other inquiries concerning this letter should be sent to FDA’s Internet Pharmacy Task Force at FDAInternetPharmacyTaskForce-CDER@fda.hhs.gov.
Howard Sklamberg, Director
Office of Compliance
Center for Drug Evaluation and Research