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Latest Updates to FDA Regulations for Serializing Drugs in the US and How Körber Can Help

Körber Supply Chain Consulting (KSCC) North America Attended the 2022 Healthcare Distribution Alliance (HDA) Traceability Seminar to Apply the Latest DSCSA Revisions to Their Award-Winning Track and Trace Software and Offer a Solution.

The US Food & Drug Administration (FDA) has mandated that pharmaceutical manufacturers and supply chain stakeholders have track and trace systems in place by November of 2023 to verify the authenticity of the products they’re producing and distributing across the United States. To meet this strict deadline, many companies are seeking assistance from outside entities with specialized expertise in solving these complex serialization challenges, which is inclusive of solutions Körber can provide. Our North American team attended the 2022 Healthcare Distribution Alliance (HDA) Traceability Seminar in Washington DC to hear about the latest developments in serialization, as well as opportunities to offer our own software solution to help ensure compliance with future FDA regulations, and maintain the highest level of service to our customers.


What is Serialization?


The complexity of pharmaceutical serialization is that inventory must assign a unique identification number to each product for all units of measure. A complete hierarchy follows the inventory from receiving to shipping. For instance, one bottle or one package of pills (aka, an “each”) is assigned a serial number and is placed in a package or box that may contain multiple eaches. That package is then assigned its own serial number. Multiple packages may be put inside a case, and multiple cases may be put on a pallet for shipping. Each level is assigned its own unique serial number and the inventory has a parent child relationship. Inventory can be tracked and traced all the way from the pallet to the each level.
The serial numbers are also tied to data in Serial Repository which contains detailed information on where the product was manufactured, when it was manufactured, the expiration date, the production batch and more.

The serial number and other attributes are stored on the unit of measure as a barcode or an RFID tag. The serial number may require a lookup against the serial repository to obtain the necessary information to receive, move, or ship product. 

Why is Serialization Important?

Cases occurred where people had died due to unregulated drugs entering the supply chain. In 2013, the US Food & Drug Administration (FDA) enacted the Drug Supply Chain Security Act (DSCSA) to protect patients and consumers from exposure to drugs that may be counterfeit, stolen, contaminated or otherwise harmful. The FDA demanded that pharmaceutical manufacturers and distributors develop methods to electronically track and trace these products at the package level – from the each to the pallet. This will allow for accurate identification and monitoring of prescription drugs as they are distributed in the US. 
The challenge is to get all stakeholders involved in the pharmaceutical supply chain – the drug manufacturers, distributors, wholesalers, retailers – united on a uniform standard or structured system of formatting the data across the supply chain. GS1, a global, non-profit organization, developed a common data language to make serialization possible. The messaging is referred to as the Electronic Product Code Information Code (EPCIS). EPCIS enables users to gain a shared view of physical or digital objects within a relevant business context.

The Latest Regulations

The EPCIS 1.3 standards were recently ratified on October 5, 2022.  The changes from release 1.2 to 1.3 include the following:

  • Expanded the verification context to include verification for a suspect or illegitimate product investigation, exception processing, and status check.
  • Added Possession or Control Attestation indicator for the requester.
  • Include "ExpirationExtended" and "Illegitimate" to additional information returned in the verification response.
  • Added a verification response scenario to address verification of product identifier with an extended expiration date.
  • Added Contact information, either email or phone number must be provided, to allow requesters and responders to resolve issues outside of the messaging system.

The DSCSA laws include a list of guidance documents. These most often are recommendations and not laws, but they should be taken seriously November 2023 begins enhanced serialized transaction information including:

  • National Drug Code (NDC) number of the product
  • Lot number of the Product
  • Serial Number
  • Expiration Date

Guidance around Verification Systems outlines need for a robust verification system for determination, quarantine, and investigation of suspect products, and quarantine, notification, and disposition of illegitimate products. The guidance documents outline or give direction on the following:

  • How trading partners submit cleared product notifications to FDA
  • How to address verification of saleable returns at the package level for product identifiers on packages and homogeneous cases intended to be introduced in a transaction in to commerce.
  • Established licensing standards for Wholesale Distributors and 3PLs.
  • NDC – new proposed regulation around the NDC format and labeling barcodes - needed to standardize and simplify the NDC format from 5 to 1 uniform format
  • Conveys how everyone will be affected by the changes in the NDC format
  • The new NDC will be a 12-digit format itself

How Körber Can Help

Most serialization software solutions are combination of Level 1 and Level 2 (manufacturing line hardware and packaging), L3 Plant level manufacturing and Warehouse, and Level 4 (Corporate repository). Körber STEPLogic Trace software solution would be a Level 3 system used in manufacturing or warehouse sites.
What makes STEPLogic Trace an ideal solution for serialization? Trace uses EPCIS messaging and can integrate with all of the Level 4 repository systems. Many of the popular repository organizations are creating their own serialization software that integrates only with their repository. STEPLogic Trace was developed to integrate seamlessly with industry-leading BlueYonder Warehouse Management System (WMS) and legacy systems.  Trace can be integrated with WCS and MES systems through APIs.  Trace gives also users ability to design new processes through Process Builder to capture, validate and build hierarchies of serialized inventories.

There should be opportunities for STEPLogic Trace to help those that are struggling to figure out how to meet the requirements of DSCSA, while trying to limit the expense of software and labor to make that happen.

Körber has over 20 years of experience working in the pharma industry with serialization and the results are a robust, adaptable solution of STEPLogic Trace. The latest software release is compliant with the DSCSA regulations to allow our clients meet the FDA’s November 2023 deadline. 


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