Beginning next November, pharmaceutical companies will be required to mark their products with a National Drug Code (NDC), serial number, lot number and expiration date in both machine-readable and human-readable format thanks to the Drug Supply Chain Security Act (DSCSA) of 2013.
In preparation for that deadline and others over the next seven years, a diverse group of 44 companies – from manufacturers to wholesalers to solution providers – came together to develop an updated GS1 guideline, released 7 November, on the use of GS1's Electronic Product Code Information Services (EPCIS) for lot-level management and item-level traceability of pharmaceuticals.
Peter Sturtevant, senior director of industry development at GS1 US, told Focus that he’s heard anecdotally that 12-15% of drugs have such 2D matrix barcodes already, though companies are currently ramping up work.
Background on DSCSA
Intended to keep the pharmaceutical supply chain more secure and further protect patients, the DSCSA mandates the creation of an electronic, interoperable system to track and trace certain prescription drugs distributed in the US. At least 40 other countries use or are in various stages of developing such serialization systems, including Turkey, China, Argentina, Brazil and the EU, though none are the same and there are no current plans for worldwide harmonization.
DSCSA, which will be implemented over 10 years, requires the creation of certain reports to track the progress of how the legislation is helping further protect the pharmaceutical supply chain and companies are transitioning their systems and preparing for the various requirements in three phases (though the DSCSA law sets 2023 as the final required deadline for serialized pharmaceutical traceability):
- Phase one, which began 1 January 2015, requires pharma supply chain participants to share lot-level transaction information, transaction history and transaction statements at each sale/transfer of ownership (the use of EPCIS events for lot-level management is covered in the guideline).
- Phase two, starting no later than November 2017, requires that pharmaceuticals are marked with a National Drug Code, serial number, lot number and expiration date in both machine-readable and human-readable format (the use of GS1 Identification Numbers, Application Identifiers, and Data Carriers (barcodes and RFID tags) are covered in the updated guideline).
- Phase three requires trading partners share chain-of-ownership data in a manner that allows for serialized item traceability back to the product origin (usually the manufacturer) (The expanded use of EPCIS events for serialized item traceability are also covered in the updated guideline).
The 600+ page GS1 guideline and compendia offer information and examples to the wider industry looking to meet the law's obligations and record each shipping event and data element needed to support serialization, pedigree and track and trace. The guideline also shows industry how to apply the standards to their own businesses.
Sturtevant told Focus that right now, one of the biggest questions is on the idea of aggregation.
Aggregation allows for companies to track the relationships between the various parts of packages in a shipment of pharmaceuticals, essentially allowing a receiver to scan one code and understand what is in each part.
“The majority are probably preferring aggregation,” Sturtevant said, noting that some of the largest wholesale distributors have said it’s a requirement that companies use aggregation, “but it’s still a point of contention out there.”
The US Food and Drug Administration also is expected to release several guidance documents related to the DSCSA and Sturtevant said industry is moving forward to meet next year's requirements and do not expect to need any additional time to meet them, though FDA has had to delay implementation deadlines in the past.
Changes in the Revised Guideline
In terms of the changes made in the release of version 1.2 of the guideline as compared to 1.1, the guideline notes:
- EPCIS event specifications for lot-level management have been updated to take advantage of new features in EPCIS 1.2 and CBV 1.2. In Release 1.1 of the guideline, only features of EPCIS 1.1 and CBV 1.1 were used, requiring the use of custom extensions. See Section 1.4.1 for more details.
- EPCIS event specifications for serialized item traceability have been updated to provide for all data requirements of DSCSA, and to take advantage of new features in EPCIS 1.2 and CBV 1.2. In 1.1, EPCIS event specifications for serialized traceability were based on data requirements of the 2015 California drug pedigree law, and only features of EPCIS 1.1 and CBV 1.1 were used, requiring the use of custom extensions. See Section 1.4.2 for more details.
- For both lot-level management and serialized item traceability, exception scenarios have been added, including detailed flowcharts and XML examples. Additional EPCIS event specifications have been added as necessary to cover the exception scenarios.
- For DSCSA lot-level management, an EPCIS event specification for a "Transformation" event is added to address repackaging scenarios.
- Additional clarification has been added on the handling of expiration dates, including the need to synchronize the expiration date printed on the label, encoded in the barcode and reported in EPCIS, as well as strongly recommending that a day of month always be included.
- Additional clarification on EPCIS event times.
- Guidance on best practices when a party notifies a trading partner of an exception condition.
- The section numbering and document formatting have been updated for better readability.
Sturtevant told Focus there are 16 different exceptions that have been evaluated, including cases where there is damage to product or failures on the IT side.
GS1 US DSCSA Implementation Suite