The FDA’s 12 month delay in enforcing the Drug Supply Chain Security Act (DSCSA) requirement for all RX products in cases to be serialized was meant to give industry more time to comply with the new regulation, but this extra time does not modify the Act or change the enforcement date of its later provisions. The extra time may seem sufficient for companies who have delayed their serialization efforts, but many companies are finding serialization to be more involved than they expected, as they encounter unforeseen issues and delays during several phases of their project. These problems have several causes, including the immature technology being used, the miscalculation of resources required to implement the system, and the failure to identify the system’s true capabilities until it is too late. This whitepaper discusses common mistakes made before, during, and after the implementation of a serialization system and offers ideas to minimize or eliminate the problems associated with adding serialization to a supply chain.
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