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Article Summary: FDA Is Unable To Determine That These Drug Products Marketed For Sale
FDA Is Unable To Determine That These Drug Products Marketed For Sale
MERIDIA,PROPECIA,and other medicines being offered for sale are prescription drugs in the United States (U.S.). FDA is unable to determine that these drug products marketed by your firm have been made in accordance with the U.S. specifications and are the same products marketed legally in the United States. Therefore, the sale and distribution of these products on your Internet web site may be illegal in this country and may be in violation of Title 21 of the United States Code, Sections 331(a), 331(d),
and 355(a).
Many prescription drugs available from foreign sources are either products for which there is no U.S. approved counterpart or foreign versions of FDA-approved drugs. In either case, these products are not approved for use in theU.S. and therefore, it is illegal for a foreign source to ship these products into the U.S. In our experience, many drugs obtained from foreign sources that purport to be the same as U.S. approved prescription drugs have been of unknown quality. FDA approves a drug on the basis of scientific data submitted by the drug sponsor to demonstrate that the drug is safe and effective. We cannot provide assurance to the American public that the drugs ordered from your web
site are the same products approved by FDA and prescribed by the consumer's physician. In addition, federal law prohibits the sale of prescription drugs to U.S. citizens without a valid prescription, 21 U.S.C. Section 353(b).
p>The agency is taking steps to warn our citizens that drugs promoted and sold from foreign sources via the Internet maynot be approved for marketing in this country. With copies of this letter, we are advising the regulatory drug officialsin the countries from which you operate of these potential violations. We are also advising the U.S. Customs Service through an Import Alert that all shipments offered for importation into the United States as a result of your activities may be detained and subject to refusal of entry.
FDA would like to take this opportunity to clarify the agency's policy concerning the importation of pharmaceutical products for personal use. For many years, FDA has permitted individuals and their physicians to bring into the United States small quantities of drugs sold abroad, but not approved in the U.S. for a patient's treatment of a serious condition. This compassionate approach has been applied to products that do not represent an unreasonable risk andfor which there is no known commercialization or promotion to persons residing in the U.S. A patient seeking to import such product must also provide the name of the licensed physician in the U.S. responsible for his or her
treatment with the unapproved drug product. The VIAGRAâ, MERIDIAâ, PROPECIAâ, and other prescription medicines ordered from your web site do not meet the criteria in FDA's personal use policy. If you or anyone you know has taken Meridia and has experienced any negative symptoms or side-effects, please contact our expert lawyers and obtain a case evaluation at no cost to you..
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