2022 Industry Serialization Requirements: Assessing 3PL Options for Sending EPCIS Data to Distributors

Pharmaceutical manufacturers currently share transaction data with their trading partners at the lot level. The Drug Supply Chain Security Act (DSCSA) mandates package level traceability by November 2023. Cardinal Health and McKesson are requiring that manufacturers provide fully aggregated EPCIS data by November 2022. This timing allows them to work through implementation issues and begin sending data to dispensers by the 2023 deadline. We expect other distributors to follow their lead and require EPCIS data well before November 2023. Pushing “Fast Forward” on Serialization Requirements outlines immediate steps manufacturers can take towards meeting the requirements in 2022.

Assessing 3PL options for sending serialization data
Stephanie L Byrne is a senior supply chain consultant and serialization lead focusing on DSCSA project leadership. She has helped more than a dozen life sciences companies realize the greatest impact from their serialization projects by bridging the gap between sound strategy and reliable execution.

Sending EPCIS Data to Distributors: Assessing 3PL Options

Many manufacturers contract with 3PLs for warehousing, logistics, and order fulfillment services. The 3PL executes shipment of product to customers. For these companies, serialization data for shipments gets captured via outbound scanning at the 3PL. Manufacturers have two main options to send EPCIS data to their distributors depending upon their 3PL’s capabilities:

Options for sending EPCIS data to distributors with 3PL involvement

Manufacturer Risk and Cost Assessment

When evaluating the 3PLs’ options for sending EPCIS data, manufacturers should consider the short- and long-term risks and costs involved.

Here is a summary of key risks and costs:

Table of key risks and costs for manufacturers

Other Considerations for Manufacturers

There are other circumstances that manufacturers may face that could also affect the assessment:

  • Historical Serialization Data – Manufacturers already serializing product but not sending the data to their 3PL need to consider whether the 3PL can migrate historical data into their system. If a 3PL cannot migrate historical data, then they are not able to supply full product verification or Verification Router Service for the manufacturer. If they can migrate the data, then the manufacturer needs to consider the risk and cost of that data migration.
  • Multiple 3PLs – Manufacturers who plan to use multiple 3PLs need to consider how they will manage serialization data across both companies. In this case, using their own track & trace solution to receive data from all 3PLs and then send it downstream to distributors may make the most sense.
  • Ex-U.S. Product – Manufacturers who are currently serializing products for markets outside the U.S. will need to support their serialization/track & trace systems for those markets. In this case, using their own track & trace solution rather than a 3PL’s generally makes the most sense. This way they do not have multiple systems of record for serialization data.
  • First Product Launch/No Serialization Solution Currently in Place – Emerging virtual manufacturers who are in the process of launching their first product in the U.S., and who have not yet implemented a serialization/track & trace solution, may save time and expense by using their 3PL’s full serialization services offering rather than implementing their own. This option can also offer benefits for companies looking to conserve cash leading up to commercial launch.

Key Takeaways

  • Manufacturers need to take immediate action to evaluate options for meeting requirements for sending EPCIS serialization data to distributors.
  • Assess both compliance and implementation risks, as well as identify potential mitigation strategies.
  • Consider both short- and long-term costs for setting up and supporting solutions, and resource requirements for performing ongoing processes like product verification.
  • There is no one best solution; the correct solution is one that provides a comfortable level of risk based on the manufacturer’s unique situation and comes with a manageable price tag.

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