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Regulatory and Functional Considerations for Incorporating Physical-Chemical Identifiers into Oral Solid-Dosage Drugs

By Michael O’Neill, Chief Science Officer, TruTag Technologies


Unauthorized diversion and falsification of drug products creates safety risks in the supply chain, creating life-threatening risk for patients and reducing revenue, profitability and brand equity for drug owners. As the regulatory landscape around the world becomes more harmonized with FDA’s PCID guidance, drug makers should investigate how to implement an on-dose authentication solution as part of a comprehensive product security and tracking program for the key drug products that are susceptible to diversion and counterfeiting.

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