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Despite Covid-19 challenges, manufacturers and distributors work to obey DSCA requirements
A survey released yesterday by the Healthcare Distribution Alliance (HDA) Research Foundation suggests that, overall, the pharmaceutical supply chain continues to make steady progress to comply with the 2013 Drug Supply Chain Security Act (DSCSA).
Back in April, the FDA made a DSCSA announcement that would help expedite drug deliveries from suppliers to where they were needed by suspending some distributor requirements; however, some implementation priorities have shifted amid the initial industry response to the Covid-19 pandemic.
HDA's new “Serialization Readiness Survey” determines the current preparedness of manufacturers and distributors to meet DSCSA requirements, when distributors can expect to begin receiving serialized product, as well as perceptions of dispenser readiness. Survey responses were collected prior to FDA’s announcement of additional enforcement discretion related to certain DSCSA dispenser and wholesale distributor requirements. The agency is now permitting until Nov. 27, 2023, for compliance.
Data reflect the survey responses of 57 manufacturers—including 14 of the 2018 top 20 pharmaceutical manufacturers by sales and nine of the top 20 manufacturers by prescriptions dispensed as listed by IQVIA—and 21 distributors. Among the findings: