The Drug Supply Chain Security Act (DSCSA) requires pharmaceutical trading partners to share data that tracks products and provides traceability through the supply chain. The sharing of serialization data relies on Electronic Product Code Information Services (EPCIS), an internationally accepted GS1 standard. EPCIS supports interoperable exchange of serialization data between trading partners.
Today, DSCSA only requires sending lot-level transaction data. However, full traceability requirements mandate EPCIS data exchange at the serialized package level by November 27, 2023. This will require cooperation between manufacturers, wholesale distributors, service providers and other supply chain members. The increased traceability is ultimately intended to enhance U.S. pharmaceutical supply chain security.
AmerisourceBergen, Cardinal Health and McKesson recently addressed these requirements proactively.
- AmerisourceBergen issued a position paper aimed at its pharmaceutical suppliers in June 2021 outlining milestones over the next two years leading up to manufacturers sending fully aggregated EPCIS data by July 2023. Read the paper from AmerisourceBergen here.
- Cardinal Health and McKesson followed with supplier letterstating EPCIS data will be required by November 2022. This requirement includes their traditional wholesale distribution as well as specialty distribution arms and is driven by the need to work through issues in collecting serialization data and sending it on to dispensers. Read the letter from Cardinal Health here.
Other distributors will likely follow their lead. Specialty pharmacy providers and other dispensers may also begin demanding data in advance of the 2023 enforcement deadline.
Manufacturers must now prepare to provide serialization data to at least Cardinal Health and McKesson by November 2022 – a full year earlier than the DSCSA enforcement date.
For companies using Third-Party Warehousing (3PL) partners, there are several options for establishing compliant capabilities. However, manufacturers will continue bearing the regulatory responsibility to affix serialization data to packages and homogenous cases, send serialization data to customers, store/maintain serialization records, and respond to product verification requests. This responsibility will stay with the manufacturer regardless of who performs packaging, facilitates serialization data exchange, ships physical product, or performs other related activities on behalf of the manufacturer.
Manufacturers May Send EPCIS Data Themselves
Manufacturers may use their own serialization solution and resources to send data downstream to their distributors. This includes capturing data by scanning serialized barcodes and compiling the aggregated data for shipment. This can be accomplished regardless of whether warehouse operations and scanning are performed in-house or at a 3PL. Manufacturers should work with their serialization solution provider to identify and set up the functionality needed to capture and send EPCIS data to distributors if they have not already.
Manufacturers May Contract with Their 3PL Partner for EPCIS Data
When manufacturers contract with 3PLs for warehousing, logistics, and/or order fulfillment services, the 3PL also performs physical shipment of product to customers. Many 3PLs are establishing capabilities to capture serialization data for shipments during outbound scanning, and depending upon those capabilities, manufacturers may be able to leverage their services to send EPCIS data to distributors.
For a detailed outline of the costs and risks manufacturers should consider while evaluating their 3PL options, check out 2022 Industry Serialization Requirements: Assessing 3PL Options for Sending EPCIS Data to Distributors.
The full traceability requirements stand regardless of whether the manufacturer is already serializing commercial products or is planning a commercial launch in 2022.
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