Pharmaceutical Industry Makes Slow Progress on Meeting DSCSA Serialization Requirements

The FDA’s deadline of November 27, 2023, to comply with the Drug Supply Chain Security Act (DSCSA) is imminent. However, survey results from the HDA Research Foundation, a nonprofit charitable organization of the Healthcare Distribution Alliance (HDA), revealed that the industry had made slow progress in complying with the mandate. Pharmaceutical serialization remains a goal to be attained for the industry.

November 2023 Deadline Approaching

By the November 2023 cutoff date, trading partners will be required to exchange pharmaceutical product transaction information and statements in a secure, interoperable, and electronic manner. In the US and many other nations, the pharmaceutical industry has adopted EPCIS standards for automatic data communication amongst partners in the supply chain. Additionally, systems and processes must be in place to provide this information to trading partners as requested.

Manufacturers Suppliers Not Yet Providing Serialization Data for Entire Product Lines

The HDA Research Foundation’s Serialization Readiness Survey uncovered that three-quarters of surveyed pharmaceutical manufacturers expect to send 100% of DSCSA-required serialized data with shipped products by the closing date. Although many healthcare distributors disclosed that they can receive serialized product today, they also reveal that most manufacturers suppliers at this point have yet to provide data for entire product lines.

Collaboration With Trading Partners Key Challenge for Manufacturers and Distributors

In the report, 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.

Additional Key Findings

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 are concerned 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.

To read the report in its entirety, click here.

With the various file formats companies use, sharing data can be a very complex process. Trading partners and pharma serialization providers must collaborate to verify that they can pass EPCIS data successfully. As we get closer to November 2023, manufacturers are putting themselves at risk for non-compliance if they delay onboarding EPCIS data exchange.

Read our Interoperability Mandate eBook to uncover what steps to take to prepare for the looming DSCSA deadline.