Manufacturers Need to Start Now to Prepare for 2022 Serialization Requirements

While the Drug Supply Chain Security Act (DSCSA) does not require manufacturers to send package-level serialization data downstream until November 27, 2023, the Big 3 distributors are accelerating this timeline and requiring that data by November 2022. Cardinal Health and McKesson are driving this effort in order to work through expected issues and begin providing package-level serialization data to dispensers in the first half of 2023.

During November’s Healthcare Distribution Alliance (HDA) Traceability Seminar, the FDA emphasized the importance of pushing “fast-forward” on full traceability efforts. This will involve sending package-level serialization data at each step through the supply chain. Distributor and dispenser community members also highlighted the need for all partners, and especially manufacturers, to ramp up efforts immediately so the whole industry is ready for 2023.

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.
Gathering package-level serialization data

Why is this Important to Biopharmaceutical Manufacturers?

According to the HDA Research Foundation’s “Serialization Readiness Survey”, only 44.7% of manufacturers are aggregating data for all product SKUs. Also, only 40% of manufacturers plan to send some serialization data to their wholesale distributor customers by end of 2021. For manufacturers that still need to implement full aggregation, activity needs to start early in 2022 because it may involve purchase, installation, and qualification of new equipment on the packaging line which can take three months or more. Even if manufacturers have full aggregation, evaluating and implementing options for sending EPCIS data to distributors can take six months. All these efforts involve cost that needs budget for 2022.

While HDA distributors appear to appreciate the manufacturers’ challenges, their own compliance efforts hinge on getting that data. They may provide some leniency if manufacturers are demonstrating a good faith effort and progressing towards providing the serialization data, but they might hold firm to timelines to ensure their own DSCSA compliance. Distributors may refuse to purchase drugs from manufacturers who do not provide compliant serialization data by November 27, 2022.

Key Takeaways

Manufacturers must prepare now to enable providing EPCIS-compliant serialization data to wholesalers and distributors by November 2022.

For smaller and growing biopharma manufacturing companies, evaluate your current serialization capabilities across products, packagers, 3PLs, and serialization/track & trace solutions. Address the following questions:

  • For each product at each packager, are your packaging lines currently capable of aggregation?
  • If so, are you currently aggregating serialization data from the individual units to the pallet level? And is fully aggregated serialization data currently sent to the 3PL for use in the goods receipt?
  • Does your 3PL have the capability to perform outbound scanning and the sending of outbound serialization data? If not now, when? (Outbound refers to shipment to your customer such as a distributor or specialty pharmacy provider.)
  • What specific options does your 3PL offer in terms of sending the outbound serialization data? And what is the typical on-boarding/implementation timeline for each?
  • If you have a serialization management system/track & trace solution in place, does it have the capability to send serialization data to the distributors? If so, what is needed to set up and test this capability?

Only after answering these questions can manufacturers develop a plan and ensure adequate budget to meet the November 2022 deadline.

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