Industry body publishes more DSCSA guidance

With just a few months before the US traceability scheme for prescription medicines comes into full force, an industry consortium has published new chapters in a guide to help pharma companies and their trading partners comply with the requirements.

The deadline for implementing the Drug Supply Chain Security Act (DSCSA) is coming up on November 27, requiring a full traceability system for medicines distributed in the US market to be in place, revolving around unique product identifiers on packs that allows their journey along the supply chain to be tracked.

The DSCSA was enacted in 2013 to boost the FDA's ability to protect US patients by developing a connected, digital system to trace prescription drugs throughout the country and identify counterfeit, stolen or contaminated medicine before it reaches the hands of consumers.

To help the industry get ready, the Partnership for DSCSA Governance (PDG) – an industry consortium representing more than 60 pharma supply chain stakeholders and a public-private partnership with the FDA – has just released four additional chapters of its Foundational Blueprint for 2023 Interoperability.

The blueprint provides a model that companies can follow to set up a system to comply with the DSCSA, and the new chapters have emerged after an initial chapter explaining the overarching business and compliance requirements was published in 2021.

Chapter 2 covers the functional design of an interoperable system, chapter 3 deals with the transaction information (TI) and transaction statement (TS) data that needs to be exchanged between supply chain partners, and chapter 4 provides detailed information on how electronic product identifier verification will operate.

Finally, chapter 5 looks at how TI/TS data is gathered to form a trace of drug product ownership going back to the manufacturer or repackager to support suspect, illegitimate and recalled product investigations.

"The expanded blueprint is a critical milestone and will significantly contribute to the industry's efforts to achieve DSCSA interoperability by the November 27, 2023 deadline," said PDG executive director Eric Marshall.

"While the Blueprint does not carry the force of law, it does represent the consensus best thinking of more than 60 of the nation's leading DSCSA stakeholders."