Event Recap: 2022 & Beyond – Serialization Requirements for Manufacturers

To ensure product safety, the Drug Supply Chain Security Act (DSCSA) requires pharmaceutical trading partners to share data that tracks product movement and traceability through the supply chain. The sharing of data is dependent on the Electronic Product Code Information System (EPCIS). Although DSCSA requires full traceability and EPCIS data for all shipments by November 2023, distributors are anticipating this deadline and setting their own requirements with advanced deadlines for manufacturers.

Clinician evaluating serialization requirements for manufacturing

Earlier this year, our Life Sciences Supply Chain Working Group discussed how recent announcements by the Big 3 wholesalers/distributors are accelerating manufacturers’ timelines. Life science companies that operate with external manufacturing and warehousing partners are evaluating their available options to prepare and ensure compliance.

The conversation opened with our Managing Director Todd Applebaum providing an overview and background on the DSCSA requirements enacted in 2013. This included the serialization requirements for manufacturers in 2017, distributors in 2019, and the end-to-end traceability and aggregation in 2023. Although the DSCSA enforcement date for end-to-end traceability is November 2023, Cardinal and McKesson are already requiring EPCIS data for all shipments to them no later than November 2022. AmerisourceBergen’s deadline is July 2023. As a result, the industry is seeing other distributors following suit and requiring data earlier than the DSCSA mandate. In addition, some distributors will require both Verification Router Service (VRS) and EPCIS data in advance of the official enforcement deadline for Saleable Returns Verification. Electronic T3 (lot level data) is still required by November 2023.

Applebaum provided statistics on industry preparation for 2023. At the end of 2021, 47% of manufacturers were already providing aggregated serialization data. Also, 88% of manufacturers were using EPCIS 1.2, while 97% planned to use VRS to support saleable returns. These numbers indicate that manufacturers are already working to prepare for the traceability requirements – two years before the deadline dictated by the DSCSA. Overall, the industry is moving in a positive direction for compliance.

He emphasized the importance of preparing in advance for the requirements, especially due to additional manufacturing challenges. These include:

  • Governance of the interoperable system
  • Establishing standards
  • Collaboration with trading partners
  • Differences in interpretation of the regulations

Achieving Full Product Traceability

Stephanie Byrne, Senior Consultant & Serialization Practice Lead at Converge, explained two options for sending serialization data downstream to wholesale distributors. The two methods both enable full traceability and compliance with the current regulations as well as distributor requirements.

  1. Brand Owner Track & Trace Solution: Data transfer from the 3PL to the brand owner and then to the distributor
  2. 3PL Track & Trace Solution: Data sent directly from the 3PL to the distributor

She described how manufacturers can evaluate which method suits their needs better based on compliance risk, implementation risk, and cost.

Serialization requirements for manufacturing include full product traceability. Deciding which approach works best for your company may be informed by implementation risk, compliance risk, and/or cost.

In general, the Brand Owner Track & Trace Solution provides greater control for the brand owner, reducing compliance risk but with higher implementation risk and cost. The 3PL Track & Trace Solution reduces cost and implementation burden. However, since the data is handled by the 3PL, it tends to increase compliance risk.

Choosing the Correct Track & Trace Solution for Downstream EPCIS

Dean Caravoulias, Senior Director of Commercial Supply Chain at Apellis Pharmaceuticals, shared his experience in choosing the downstream EPCIS solution for Apellis. He led his team in an evaluation of the different solutions and chose to implement a 3PL Track & Trace Solution.

When Apellis was making this decision, the company faced resource constraints due to the effort involved in preparing for their first commercial launch. By choosing the 3PL Track & Trace Solution method, they were able to rely on their 3PL to set up the software and customer connections. Caravoulias highlighted that this was an initial concern for his team since visibility to information was a priority. However, Apellis’ 3PL demonstrated the capability to share data whenever requested. The company is now planning a quality audit to ensure the 3PL continues to meet all DSCSA requirements and adequately share serialization data.

During the Q&A session, a participant asked about the time it would take to select a vendor and complete the set up for sending EPCIS data. Byrne suggested that it can take 4-6 months, including software setup and vendor onboarding. However, she emphasized that timelines are often affected by the availability of key distributor personnel, which will likely become more constrained as enforcement dates approach.

In response to additional questions, Caravoulias offered that the 3PLs, distributors, and serialization partners are great sources of information regarding serialization requirements.

Key Takeaways

  • Brand owners and manufacturers should be aware that November 2023 is the current DSCSA enforcement deadline for interoperable electronic unit-level traceability.
  • Distributor deadlines are also important to consider. Although the DSCSA enforcement deadline is in 2023, distributors are requiring EPCIS data for all inbound shipments up to a full year in advance. Manufacturers should already be working to ensure compliance with distributor-specific requirements and maintain access to services after these dates.
  • To send downstream EPCIS data to wholesale distributors, brand owners relying on an outsourced supply chain must choose a Brand Owner Track & Trace Solution or a 3PL Track & Trace Solution. Compliance risk, implementation risk, and cost are key considerations that can guide decision-making.