Source: https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2013/ucm339505.htm
Timestamp: 2019-04-25 07:49:26+00:00

Document:
Your firm offers for sale through your websites “Tamiflu 75mg Gel Tablet.” Tamiflu is a proprietary name of an FDA-approved drug, oseltamivir phosphate, well known for its intended use to treat disease (influenza). FDA has not, however, approved any Tamiflu gel tablet products.
The oseltamivir phosphate you offer for sale through your websites 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 Tamiflu gel tablet product. Accordingly, their introduction or delivery for introduction 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 websites offer prescription drugs for sale without requiring that the drugs be dispensed only upon a prescription from a practitioner licensed by law to administer such drugs. 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 websites and promotional labeling for this product misleads the consumer to believe that the “Tamiflu 75mg Gel Tablet” 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 the drug to be misbranded under 502(f)(1) of the FD&C Act [21 U.S.C. § 352(f)(1)]. Because “Tamiflu 75mg Gel Tablet” offered for sale on your websites lack 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)].
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.

References: § 321
 § 321
 § 355
 § 355
 § 331
 § 353
 § 352
 § 352
 § 201
 §331