We are on the final leg of the 10-year Drug Supply Chain Security Act (DSCSA) implementation. While the industry’s focus on COVID-19 vaccine development and distribution created delays in DSCSA compliance efforts, further delays are now doubtful. The target date for full compliance and interoperability is set for November 27, 2023. Additionally, the major pharmaceutical distributors announced plans for and expectations that all manufacturers and brand owners be fully prepared for serialization interoperability by November of 2022 – one year before the official federal deadline.
Manufacturers use pharmaceutical serialization systems to track and trace prescription drugs throughout the entire supply chain to achieve DSCSA compliance. With serialization systems, manufacturers can easily identify every product, at the item level, by a unique serial number that pinpoints the origin, shelf life, and batch number for that product, thus enabling traceability. Traceability adds visibility from a material’s origin to its delivery and offers real-time insights into a serialized product’s history, including chain of custody.
Data Must be Shared Amongst Trading Partners
DSCSA requires that data for pharmaceutical products be shared amongst trading partners as the product changes ownership during its lifecycle in the supply chain. In the US and many other nations, the pharmaceutical industry has adopted EPCIS standards for automatic data communication amongst partners in the supply chain. EPCIS is a GS1 standard that enables trading partners to share information about the products’ physical movement and status as they travel throughout the supply chain – from business to business and ultimately to consumers.
Before the final deadline wholesale distributors, dispensers, and repackagers can use either paper-based or electronic-based methods to provide transaction history, transaction information, and transaction statements to subsequent purchasing trading partners as long as the selected method allows the information to be exchanged in a manner that complies with outlined requirements.
However, beginning November 27, 2023, electronic-based approaches are required to be used among all trading partners to meet the enhanced drug distribution security requirements. Therefore, on that date, trading partners are required to use secure, interoperable, electronic approaches to:
- Exchange transaction information that includes package-level product identifiers for each package included in transactions and transaction statements
- Verify products at the package level
- Promptly respond with the transaction information and transaction statement for a product in the event of a recall or investigation
- Facilitate the gathering of transaction information for a product going back to the manufacturer in the event of a recall or for investigations
- Accept saleable returns under appropriate conditions
Prioritizing Interoperability Testing is Crucial
To successfully meet the November 27, 2023, deadline, trading partners and pharma serialization providers need to collaborate to verify that the EPCIS data can successfully be passed and, if necessary, modified and shared due to routine supply chain procedures such as breaking down pallets for order fulfillment.
Even with guidelines in existence, file formats for sharing data can vary from company to company, making it critical that manufacturers test connections with all trading partners to confirm interoperability. In addition, extensive testing is required to ensure files are properly structured and all errors are corrected before pushing to production. As a result, the integration process for EPCIS interoperability may take weeks or even months.
Every milestone of DSCSA implementation takes time, and as already experienced during the first phase of DSCSA implementation (LOT level tracking via ASNs), establishing connections between manufacturers (including contract manufacturers and repackagers) and wholesale distributors requires significant effort, resources, and time.
Uncover what steps to take now to prepare for the DSCSA deadline by reading our Interoperability Mandate eBook.