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U.S. Department of Health and Human Services

Drugs

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Combating Counterfeit Drugs May 2005 Update - Authentication Technology

In the Report, we noted that authentication technologies for pharmaceuticals (such as color-shifting inks, holograms, taggants, or chemical markers imbedded in a drug or its label) have been sufficiently perfected that they can now serve as a critical component of a layered approach to control counterfeit drugs. FDA's Report acknowledged the importance of using one or more authentication technologies for drug products, in particular those most likely to be counterfeited. Over the past year, we have worked with individual drug manufacturers who sought to incorporate such technologies into their product, labeling, or packaging. When asked, we have provided advice and suggestions regarding application and use of authentication technologies and worked with sponsors on the regulatory issues associated with making changes to approved product labeling.

In the Report, we said that in order to facilitate the use of authentication technologies on or in approved products, we would consider publishing a draft guidance on notification procedures for making changes to products, their packaging, or their labeling. We decided not to issue guidance in the past year because we would like to gain additional experience working with companies in their application and use of authentication technologies so the guidance can have appropriate general applicability.

Next Steps: We will continue to work with companies and organizations to facilitate use of authentication technologies in products, labeling, and packaging.