CDER CYBER LETTERS.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 prescription drug Prescription medication Pharmacology An FDA-approved drug which must, by federal law or regulation, be dispensed only pursuant to a prescription–eg, finished dose form and active ingredients subject to the provisos of the Federal Food, Drug, from Web sites. Copies of these letters are available from our RECORD-RETRIEVE Service for $7 plus retrieval. 10519W #1 Drugstore Online, Singapore, April 24 (CDER-OC). FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. cited the firm for promoting the sale of Tramol (tramadol HCL tramadol HCl (tram´ n brand name: Ultram; drug class: synthetic opioid analgesic; action: ) 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 10520W SamjinPharm, Seoul, Korea, April 24 (CDER-OC). The letter deemed the company's Web site, which was allegedly promoting sales of naloxone HCL naloxone HCl (nalok´sōn), n brand name: Narcan; drug class: narcotic antagonist; action: competes with narcotics at narcotic receptor sites; uses: and "Samjin lidocaine lidocaine /li·do·caine/ (li´do-kan) an anesthetic with sedative, analgesic, and cardiac depressant properties, applied topically in the form of the base or hydrochloride salt as a local anesthetic; also used in the latter form as a ," 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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