When I last provided a comprehensive Drug Supply Chain Security Act (DSCSA) update two years ago, verification was a major theme required of 2019 Saleable Returns for wholesalers. That requirement also permeated to unit level verification for all partners involved. In September 2020, the FDA delayed unit level verification requirements for returned resaleable products for wholesale distributors to 2023, which coincides with the packaging level product trace requirement.
As industry stakeholders for DSCSA, we normally gather at HDA conferences and GS1 conferences a few times each year to compare notes and exchange statuses. The Covid-19 pandemic prevented such in-person gatherings unfortunately in 2020 and for the first part of 2021.
HDA did carry out DMC last June and Traceability last October virtually as did GS1 with its GS1 Connect event. If you missed those virtual events and feel a bit removed from knowing the latest DSCSA progress, you are not alone. This article provides a broader picture of the current state of DSCSA: how far we have all come, and where we are headed.
Keep in mind, the deadline for compliance with the latest requirements are less than two and a half years away.
1 DSCSA Serialization: What We’ve Accomplished
From 2013 to now (March 20201), many DSCSA milestones requirements have been accomplished by the industry and enforced by the FDA.
- Authorized trading partners: Manufacturers, wholesale distributors, repackagers, and dispensers can trade only with authorized partners.
- Product Tracing at the lot level: Manufacturers must send electronic product tracing document including transaction information, transaction history, and transaction statements (3Ts) and the drug wholesale distributors must receive electronic product tracing document before receiving shipment into inventory when drug products change ownership in the supply chain.
- Verification at the lot level: Manufacturers, wholesalers, repackagers, and dispensers must establish systems and processes to notify FDA and other stakeholders if an illegitimate drug is found.
- Verification at the package level: Although the verification of returned resaleable products requirement for wholesalers are delayed, the verification requirement at the serial level is effective for the manufacturer. Manufacturers must perform serial level verification upon receiving a verification requirement from their downstream customers.
2 DSCSA Serialization: What’s on the Horizon?
The pharma industry has been on the journey of DSCSA implementation for over seven years now. Yet the biggest implementation is still ahead of us. It will change every step of how we do business. On November 27, 2023, “the interoperable, electronic tracing of product at the package level requirements shall go into effect” as required by the FDA.
What are the next major milestones then? These mandates will become effective November 2023.
- Product tracing at the package level: All trading partners in the supply chain must exchange electronic tracing documents at the package level when products change ownerships in the supply chain.
- Product verification at the package level: Wholesale distributors must verify all returned resaleable products at the package level before returning them to inventory.
For serial level tracing, the industry has adopted GS1’s EPCIS standard for implementation. For serial verification, the industry has adopted Verification Router Service (VRS) in conjunction of leveraging one’s own EPCIS data repository. To learn more about DSCSA Requirements and its implementation guidance, please download the follow LSPediA whitepapers:
- DSCSA Requirement for Manufacturers
- DSCSA Requirement for Wholesaler Distributors
- DSCSA Requirement for Dispensers
3 Journey to 2023
If your lot level tracing was challenging and difficult to implement, your journey to 2023’s serial level product tracing will not be easy either for several reasons.
One, the size of the data goes from lot to serial. Serial data is a thousand times the multiple of lot data.
Two, the EPCIS 1.3 standard will soon to be published, and most of the manufacturers are still on EPCIS 1.0 or 1.1.
Last but not the least, to send outbound EPCIS data means turning on outbound serialized shipping at the package level including unit level packages and aggregated case level packages.
Many companies honestly think that they are done with serialization. The true answer might be surprising. There are so many uncharted territories ahead including outbound serialized shipping, the implementation of EPCIS 1.2 and 1.3, and the ability to manage exceptions when an EPCIS data file fails. Any misstep can lead to shipment quarantine and supply chain interruption.
4 Risk Mitigation
If there is a single common goal across all companies’ serialization efforts, it is addressing the need to make DSCSA transactions better, faster, and easier.
The reality is that too many pharmaceutical companies bear the weight of their legacy EPCIS systems. These systems are clunky, labor intensive, error prone, and more complex than necessary. A common refrain I hear is that “if it isn’t broken, don’t fix it”. If you are experiencing perpetual system issues, shipment quarantines, and have difficulty accessing data, your system is broken. At any point, your business may face major shipment interruptions, supply chain interruptions, and data corruption.
The financial and operational cost of sticking with legacy EPCIS system will only increase with the next milestone of serial tracing and serial verification. It simply cannot be ignored. The alternative is lost revenue, customers, and brand equity – possibly forever.
5 Make the switch to LSPediA
Your journey to 2023 Interoperability Compliance starts today. I recommend taking an inventory of what you have already done, then assess what you need. You can accomplish this quickly taking a free DSCSA 2023 self-audit based on your industry sector.
- Free DSCSA 2023 Readiness Self-Audit for manufacturers
- Free DSCSA 2023 Readiness Self-Audit for wholesale distributors
- Free DSCSA 2023 Readiness Self-Audit for dispensers
A proven solution that can handle product tracing, serialization, verification, and exceptions management is a must have to ensure that you can reach the next milestones in 2023. LSPediA’s comprehensive OneScan solution suite is the fasted growing DSCSA solution for pharmaceutical manufacturers, wholesalers, and dispensers.
If you are looking for a software solution provider to help you clean up the problems, improve your relationship with your customers, and improve your operations, I encourage you to contact LSPediA today. It can be the first step in streamlining your processes, automating your operations, and supporting your compliance success.