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Article | March 31, 2004
Preventing counterfeit drugs
The Food and Drug Administration’s Counterfeit Drug Task Force released a report describing a framework designed to prevent counterfeit drugs for the pharmaceutical supply chain.
• Common use of reliable track-and-trace technology by 2007 most likely radio-frequency identification (RFID) tagging of products by manufacturers wholesalers and retailers.
• Use of authentication technologies such as color shifting inks holograms fingerprints taggants or chemical markers. FDA will publish guidelines on notification procedures for making changes to products its packaging or its labeling to encourage use of effective technologies for detecting counterfeit drugs.
• Use of unit-of-use packaging for each product starting with newly approved products and those likely to be counterfeited. FDA will encourage standards-setting bodies to develop standards for unit-of-use packaging.
• Use of tamper-evident packaging.
FDA noted that though both unit-of-use packaging and tamper-evident packaging may be beneficial in fighting counterfeiting of prescription drugs they are just one layer in what should be a multi-layer strategy.
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