A Q&A With Videojet on Planning for Serialization

US Drug Supply Chain Security Act (DSCSA) drug traceability requirements become mandatory beginning in 2015, and will be phased-in over the next ten years. Phase one, which started on Jan. 1, 2015 and will be in effect until December 2022, requires the exchange of "chain-of-ownership data." Beginning in November 2017, the second phase will require that "pharmaceutical products be marked with a national drug code, serial number, lot number, and expiration date in machine-readable and human-readable form." The final phase of the DSCSA requirements, starting in 2023, will require trading partners to share all data necessary to track serialized items to the product’s origin (1).

Pharmaceutical Technology spoke with Tim Kearns, pharmaceutical and medical devices manager at Videojet, about the most important aspects of the 2015 and 2017 deadlines and what to consider when planning for the 2023 deadline.

PharmTech: From your perspective, what are the most important aspects to consider when implementing equipment and systems for compliance with DSCSA 2015 and 2017 deadlines?   

Kearns (Videojet): In general, meeting the DSCSA requirements is like a jigsaw puzzle. Make sure you have a plan, build the framework, connect the pieces that fit early in the process, don’t hesitate to solicit help, and of course, make sure you use the right pieces. Specifically, identify a team and formulate a plan, find the right equipment (e.g., high resolution, serialization-ready printers) and implement early. Be sure to work with partner companies with open communication.

PharmTech: What do companies need to consider now, when installing equipment and systems, to plan ahead for future compliance with final DSCSA 2023 deadlines for item-level electronic tracking?

Kearns (Videojet): Companies must implement line-level solutions that are prepared for aggregation, set standard processes for re-work, define responsibilities, and identify and address challenges early. In the early stages, it’s important for the company to define other aspects they may be trying to accomplish. For instance, besides identifying the appropriate code and code location, companies should develop an aggregation process so a plan can be started. Also, they should consider all potential products that may run on a particular line. For example, if products will be exported, do they need to plan for adherence to other countries’ regulations?

Reference
GS1 US, "Implementation Guideline: Applying GS1 Standards to U.S. Pharmaceutical Supply Chain Business Processes, R1.1," (GS1 US, Sept. 14, 2014), pp. 8, 12-14.