Inspections, Compliance, Enforcement, and Criminal Investigations
Public Health Service
|Rockville, MD 20857
By Federal Express & Faxed to 011-66-2-946-7690
September 9, 2003
Mr. S. Vincent
1455 Tallevast Road
Sarasota, FL 34232
Dear Mr. Vincent:
The Food and Drug Administration (FDA) has learned that, through the website www.medicaparma.com. You are selling Accutane to United States (U.S.) consumers. Accutane is the trade name for a prescription drug approved for marketing in the United States under an approved new drug application by Roche Pharmaceuticals, Nutley, New Jersey. Accutane products approved for marketing in the United States are capsules for oral ingestion. Even though the medicapharma.com order from capsules the product far sale is Acculane (Roacccutane), the label of the actual product shipped states that it is Roaccutane lsotrctinoin 10 mg tablet. Roaccutane does nut have an approved new drug application, and may not be legally marketed in the United States.
You sell Roaccutane from your website without a prescription, and these orders are sent to the American consumers from Thai pharmacy. As discussed in greater detail below, these actions violate the Federal Food, Drug and Cosmetic Act (FD & C Act or Act), 21 United States Code (U.S.C.) 301 et seq.
The Roaccutane product sold through your web site is labeled in part, Roaccutane*** Isotretinoin 10 mg. ***Roche***Attention: Adhere strictly to precautions! Pregnancy forbidden! Risk of malformation***. The box containing the three strips was labeled in
part, Roaccutane***Isotretinoin 10 mg ***Attention ***Roche *** 30 capsules***insert *** Thai Reg No 1C 230/41 *** Made under license from F. Hoffmann-La Roche Ltd, Basel, Switzerland by R.P. Scherer GmbH, Eberbach, Germany. The capsules are packaged in a box containing 3 strips of 10 individually Wrapped Capsules.
Accutane (isotretinoin) is a systemically administered retinoid approved in 1982 to treat severe recalcitrant nodular acne. Isotretinoin carries significant potential risks, including that it may cause severe birth defects. The approved Accutane labeling states in part.
Accutane must not be used by females who me pregnant...must be prescribed under the System to manage Accutane Related Teratogenicity (S.M.A.R.T.), a yellow Accutane Qualification Sticker must be on each prescription, (meaning special training has been given to the prescribin, tr licensed practitioner and the patient) and no telephone or computerized prescriptions are permitted. The approved Accutane is for oral ingestion. FDA has not approved a topical gel version of Accutane or any other isotretinoin drug.
Because it has serious risks, isotrctinoin is available in the U.S. only under specially created safety controls. These safety controls are bypassed when this drug is purchased from foreign sources or over the Internet, placing patients who use this imported drug at higher risk.
The isotretinoin dispensed through medicapharma.com is also "new drug as defined by section 201(p) of the Act. Under Section 505(a) of the Act, a new drug may not be introduced or delivered for introduction into interstate commerce unless an FDA-approved new drug application (NDA) is in effect for such drug, The continued distribution of this product into the U.S. without an approved NDA is a prohibited act as set forth in Section 301 (d) of the Act.
The isotretinoin dispensed through medicapharma.com is also misbranded under section 502(f)(1) of the Act because its labeling fails to bear adequate directions for the uses for which it is being offered and it is not exempt from this requirement (See 21 CFR 201.115).
This drug is also misbranded pursuant to section 503(b)(1) of the Act because it is dispensed without a prescription.
In addition, false statements are being made by you on www.medicapharma.com, such as, Import of medicine for personal use is OK provided recipient has prescription. Copy of prescription should accompany shipment. Prescription drugs should be no more than 3 months supply or 100 count [sic]. You are giving the inccorect impreesion that all the drugs sold on the web are legal to be sold and shipped to U.S. residents. This is a false and misleading statement on your Internet site causing the drugs you distribute to be misbranded pursuant to section 502(a) of the Act.
This letter is not intended to identify all of the ways in which your activities might be in violation of United States Iaw. For example, in addition to isotretinoin, your pharmacy also offers for sale and shipment to U.S. consumers numerous other prescription drugs.
FDA believes that virtually ail shipments of prescription drugs imported from non-U.S. pharmacies will violate the Act. It is your responsibility to ensure that all drug products dispensed and distributed by you and your website into the United States are in
compliance with applicable legal requirements.
For your information, Mr. Suthapintu Vut at P.O. Box 25, Klongkum, Bangkok, 10244 Thailand was issued a Cyber Letter by FDA on March 1, 2002 (see attachment) notifying him and medicapharma.com that various drugs including Accutane may illegal in this country.
The agency has taken steps to warn our residents that drugs sold via the Internet, from foreign sources, may not be approved for marketing in this country, and may not be legally imported. With copies of this Ietter, we are advising Thailand and Florida regulatory officials of these potential violations, In addition, we are advising the Bureau of Customs and Border Protection through an Import Alert, that shipments offered for importation into the U.S. as a result of your activities may be detained and subject to refusal of entry.
You are instructed to cease these practices, and you are requested within fifteen (15) days of your receipt of this letter, to describe the actions you are taking to assure that your operations are in full compliance with United States law. Please address your
correspondence to Mr. Melvin F. Szymanski. Compliance Officer, at the U.S. Food and Drug Administration, Center for Drug Evaluation and Research, Office of Compliance. HFD-310, 5600 Fishers Lane, Rockville, MD 20857.
You should be aware that violations of the FD&C Act could result in seizure, injunction, and/or prosecution without further notice.
David J. Horowitz, Esq.
Office of Compliance
Center for Drug Evaluation and Research