Cder Cyber Letters

Warning Letter Bulletin,  July 2, 2001  

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The following untitled letters were e-mailed by the Office of Compliance at the Center for Drugs to firms that sell dietary supplements and/or prescription drugs from Web sites. Copies of these letters are available from our RECORD-RETRIEVE Service for $7 plus retrieval.

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#1 Drugstore Online, Singapore, April 24 (CDER-OC). FDA cited the firm for promoting the sale of Tramol (tramadol HCL) and Stanolol (stanozolol) because the agency could not assure consumers the drugs were made in accordance with U.S. specifications. The letter also noted that "federal law prohibits the sale of prescription drugs to U.S. citizens without a valid prescription. Web

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SamjinPharm, Seoul, Korea, April 24 (CDER-OC). The letter deemed the company's Web site, which was allegedly promoting sales of naloxone HCL and "Samjin lidocaine," violative because of availability to U.S citizens without a prescription and because the agency could not assure the products were made to U.S. standards. Web

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