Industry Needs To Be Aware of Serialization Challenges Under DSCSA
US pharmaceutical industry is warned that products “will not flow through the supply chain if the digital data is not right” under DSCSA, says official. Law’s second phase, which takes effect in November, mandates first-ever digital serialization requirements to ward off drug counterfeiting.
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Concerns that the US pharmaceutical industry will not have the necessary serialization systems in place to fully comply with DSCSA product package serialization requirement appear to be bearing fruit, according to a recent survey.
FDA will not take enforcement action against pharmaceutical manufacturers that miss this year’s serialization deadline under DSCSA. Enforcement won't begin until a year later. The serialization requirement is the second wave of a three-part system for tracking and tracing pharmaceutical products through the supply chain to thwart drug counterfeiters.
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