Drug Makers Have Exceeded Expectations In Implementing DSCSA Serialization
A new barcode assessment study finds the US pharmaceutical industry has come a long way in serializing drug products over the past several years.
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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.
The risk of inadvertently growing SARS-CoV-2 virus in cell and gene therapies and possibly infecting patients and workers should be assessed and mitigated, the agency advises.