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New HDA Research Foundation survey points to positivity for pharma supply chain

November 4, 2020

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:

  • Nearly half of manufacturers and distributors note challenges with the requirement for industry to process serialized saleable returns. Covid-19 was cited as a reason for this response, as gaining entry to company facilities has impacted the ability to train employees and implement systems as planned.
  • Approximately 5% of distributors believe that their dispenser customers understand what is required of them for overall DSCSA compliance. Moreover, nearly two-thirds (62%) of wholesale distributors report dispenser knowledge of DSCSA requirements varies considerably among pharmacy industry segments.
  • About 21% of manufacturers plan to send serialized data with 100% of products in 2020, a decrease from last year’s survey. While a majority anticipate sending 100% of data with shipped product by 2023, when it is legally required, 32% plan to first send data between 2020 and 2021, resulting in more than half of manufacturers sending data for at least some products by the end of next year.
  • Collectively, manufacturers and distributors cited collaborating with trading partners, governance, differing legal interpretations of the DSCSA and establishing standards as priorities as the industry moves toward 2023 interoperability.