By now, you know that the FDA has designated the year after November 27, 2023 as the pharmaceutical industry's "stabilization period" for DSCSA. All pharma trading partners, from manufacturers to dispensers, are expected to have systems in place before that date, and then spend the following year polishing and perfecting them. Slowing or stopping progress is not an option — in essence, the administration said, "Don't give us a reason to think you're not going to comply."
However, you may have missed the FDA's release of a cross-industry study that informed its decision. Its DSCSA Pilot Project Program, which ran from May 2019 through June 2020, had two objectives: Identifying the kinds of systems and resources trading partners would need to comply (particularly with the requirement to use a product identifier), and assessing the ability of businesses throughout the pharma supply chain to meet the law's requirements and exchange electronic, interoperable product tracing information.
The FDA highlights the importance of “cooperation from trading partners and other stakeholders (e.g., solution providers)” in achieving interoperability. It asserted that all parties “should consider how to balance supply chain transparency and security of the data.” This is directly relevant to LSPedia's ability to set up interoperable connections and enable cooperation and clear communication around the EPCIS data exchange; as well, the uptake of OneScan by hundreds of companies, including leaders at each stage in the supply chain, shows that security doesn't need to be sacrificed in establishing transparency and traceability.
As we've already seen, larger companies often step forward to take charge of deadline planning and technical implementation to ensure that their trading partners comply in time. Often, wholesale companies even provide portals to their dispenser partners to directly handle the data exchange. While these portals are a major benefit, wholesalers should be clear that dispensers still need to manage their own implementation; the addition of the wholesaler-supplied portal can confuse the dispenser, fostering the misperception that their entire DSCSA requirements have been covered. No matter how helpful the portal is, it actually serves the wholesaler's DSCSA compliance requirements — not the dispenser's.
The report argued that standardization “is important to facilitate interoperability,” specifically regarding how “the data that is provided, maintained, and received … including how the data is defined and organized.” Further, it stated that there could be industry-wide benefits from standardizing how trading partners respond to verification requests.
This is core to LSPedia's participation, and an item we’ve worked to address with our Verifier® Verification Router Service (VRS) solution. Additionally, the report said that standardizing responses to exceptions (as we’ve enabled via OneScan Investigator and pursued further with our own Exceptions Pilot) can “help with supply chain management,” resulting in “efficiencies and clarity between trading partners.”
The FDA emphasized the importance of addressing IT issues, noting that this affects operational problems such as exceptions management. It also addresses cloud technology as a way for systems to automatically interact, and enable flexible data sharing without demanding distinct system changes by either party in a connection. as OneScan’s cloud-based operation streamlines resource needs
Smart use of cloud technology has long been a focus of LSPedia's approach. In addition to enabling seamless integration with any system, our Investigator module empowers companies to carry out investigations via a secure, automated approach, reducing the need for internal IT resources to address every problem.
The FDA cautioned readers to expect changes to some business and operational processes around using the product identifier for product tracing and verification. LSPedia can help with by keeping your systems up to date and keeping you informed on your responsibilities; what's more, our team continually creates — and collaborates with customers — on Standard Operating Procedures (SOPs) for personnel to follow to ensure that all practices are in line with the most recent DSCSA developments and guidance.
The FDA advised trading partners to “allow for sufficient time needed to onboard suppliers and customers,” to “plan for technical issues with establishing … connectivity,” and to “conduct testing, particularly connectivity, with suppliers and customers.” Further, it pointed to the importance of training staff “to ensure smooth and efficient implementation and workflow integration.” We agree wholeheartedly. Though LSPedia can significantly reduce implementation time, at this point in 2023, it’s very important for companies to act now, given that EPCIS onboarding between trading partners can be time-consuming.
Read the full report for more! And if you have questions about the FDA’s findings, get in touch with us today.
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