ARLINGTON, Va. — A survey released today by the Healthcare Distribution Alliance (HDA) Research Foundation indicates the pharmaceutical supply chain continues to make steady progress to comply with the 2013 Drug Supply Chain Security Act (DSCSA); however, some implementation priorities have shifted amid the initial industry response to the COVID-19 pandemic.

The Serialization Readiness Survey, released in conjunction with HDA’s Traceability Online Seminar, gauges the current readiness 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 the Food and Drug Administration’s (FDA) announcement of additional enforcement discretion related to certain DSCSA dispenser and wholesale distributor requirements; the FDA is now permitting until November 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. This is the second year that distributors have been surveyed by the Foundation. 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 percent of distributors believe their dispenser customers understand what is required of them for overall DSCSA compliance. Moreover, nearly two-thirds (62 percent) of wholesale distributors report dispenser knowledge of DSCSA requirements varies considerably among pharmacy industry segments.
• Approximately 21 percent of manufacturers plan to send serialized data with 100 percent of products in 2020, a decrease from last year’s survey. While a majority anticipate sending 100 percent of data with shipped product by 2023, when it is legally required, 32 percent 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 top-of-mind issues as the industry moves toward 2023 interoperability.

“The Foundation’s data reaffirm the FDA’s decision related to enforcement discretion. While DSCSA implementation is still a high priority for the pharmaceutical supply chain, we can see an industry adapting and adjusting to support patients and frontline healthcare providers during the COVID-19 response,” said Perry Fri, executive vice president, Industry Relations, Membership & Education, HDA; and COO, HDA Research Foundation. “As the industry looks toward 2023 interoperability requirements, continuing education, coupled with close coordination and collaboration will be the key to overall compliance.”

The Serialization Readiness Survey executive summary is available for download through the HDA website