HDA Foundation Serialization Survey Shows Slow Progress, Industry Concerns Leading Up to 2023 DSCSA Compliance DeadlineOctober 13, 2022
According to the HDA Research Foundation’s latest Serialization Readiness Survey, three-quarters of surveyed pharmaceutical manufacturers anticipate sending 100 percent of Drug Supply Chain Security Act (DSCSA)-required serialized data with shipped products by November 27, 2023 — the deadline to comply with the law. Further, though many healthcare distributors report the ability to receive serialized product today, they also indicate that most manufacturer suppliers are not yet providing data for total product lines as the supply chain closes in on the compliance deadline.
Released in conjunction with HDA’s Traceability Seminar in Washington, D.C., the Foundation’s seventh annual survey assesses the current ability of manufacturers and distributors to meet the DSCSA serialization requirements as well as distributors’ perceived readiness of dispensers. By November 27, 2023, trading partners are required to exchange pharmaceutical product transaction information and statements in a secure, interoperable and electronic manner. Further, systems and processes must be in place to provide this information to trading partners as requested.
“The Foundation’s data show the industry is making progress, but also prompt us to ask what the operational impact to the supply chain will be come November 28, 2023, if manufacturers continue to defer their serialization investments well into the final year of DSCSA implementation,” said Perry Fri, Executive Vice President of Industry Relations, Membership & Education, HDA; and COO of the HDA Research Foundation. “Healthcare distributors have indicated that onboarding manufacturers well before the deadline as the best way to avoid possible disruptions in product flow — so aligning on plans in short order will be crucial. Likewise, dispenser education remains a priority as the FDA has indicated it will not grant further enforcement discretion in 2023.”
Manufacturers cited “collaboration with trading partners” (51 percent), “governance of the interoperable system for 2023” (49 percent) and “differences in interpretation of the law” (34 percent) as main challenges for meeting the DSCSA’s 2023 interoperability requirements. Healthcare distributors noted “collaboration with trading partners” (90 percent), “technical challenges” (72 percent) and “establishing standards” (48 percent) as top concerns leading up to that final milestone.
Survey data reflect responses from 48 manufacturers, including 16 of the 2020 top 20 pharmaceutical manufacturers by sales as listed by IQVIA, and 29 distributors. Among other findings:
- Approximately 32 percent are currently sending some serialized data today to distributors; most of those manufacturers are sending serialized data for less than 150 SKUs (45 percent).
- Manufacturers have made some progress on data aggregation. Nearly 58 percent of manufacturers are aggregating data for all SKUs (up from 45 percent last year). An additional 6 percent plan to aggregate data for all SKUs for each unit to a case by 2022. Still, a third of manufacturers plan to aggregate by 2023 — and aggregation is a prerequisite for sending serialized data.
- Most manufacturers (84 percent) have no concerns with meeting the requirement to process serialized saleable returns. Approximately 45 percent of distributors do have concerns with meeting the requirement, tied to continued lack of access to master data (though that access has improved since the 2021 survey).
- The number of distributors that can receive serialized products increased to 62 percent; most distributors that were, as of the time of the survey, not yet accepting serialized products, aimed to be ready within 2022. However, many distributors, approximately 46 percent, are still only receiving serialized data for between 1 and 5 percent of transactions.
- As in 2021, distributors report that dispenser customers’ knowledge of the 2023 DSCSA requirements varies considerably. None of the surveyed distributors reported that their dispenser customers understand their responsibilities to accept products with product identifiers and to investigate suspicious products.
The Serialization Readiness Survey, sponsored by LSPediA, 3Keys GmbH and HealthFirst is available as a complimentary download. Further, HDA has created an educational resource page in partnership with pharmacy and supply chain organizations to help the dispenser community understand what is expected of them for DSCSA compliance, and hosted several webinars geared toward this group. Additional resources and webinar recordings are available at DSCSA.pharmacy.