Issue Date: July 20, 2009
Combating Fake Drugs
FDA has issued draft guidance for industry on the use of physical-chemical identifiers (PCIDs), such as inks, pigments, and flavors, to combat the production of counterfeit drugs. PCIDs make it more difficult to duplicate drugs and make it easier to differentiate between genuine and fake ones. Some PCIDs are readily detectable by wholesalers or pharmacists, but others, such as chemicals used in products as molecular tags, can be detected only with special analytical instruments. FDA anticipates that many PCIDs will consist of ingredients such as food additives or colorants that already have established safety records. The guidance recommends that PCIDs have no medicinal effects and be used at the lowest level possible to minimize adverse effects. FDA is inviting comments regarding the use of PCIDs in pills and capsules. "Drug counterfeiting is a serious public health concern," FDA Commissioner Margaret A. Hamburg said in a statement. "We look forward to working with industry to help ensure that consumers are not exposed to products containing unknown, ineffective, or harmful ingredients."
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