According to the HDA Research Foundation’s “Serialization Readiness Survey”, only 44.7% of manufacturers are aggregating data for all product SKUs. Also, only 40% of manufacturers plan to send some serialization data to their wholesale distributor customers by end of 2021. For manufacturers that still need to implement full aggregation, activity needs to start early in 2022 because it may involve purchase, installation, and qualification of new equipment on the packaging line which can take three months or more. Even if manufacturers have full aggregation, evaluating and implementing options for sending EPCIS data to distributors can take six months. All these efforts involve cost that needs budget for 2022.
While HDA distributors appear to appreciate the manufacturers’ challenges, their own compliance efforts hinge on getting that data. They may provide some leniency if manufacturers are demonstrating a good faith effort and progressing towards providing the serialization data, but they might hold firm to timelines to ensure their own DSCSA compliance. Distributors may refuse to purchase drugs from manufacturers who do not provide compliant serialization data by November 27, 2022.
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