What were the FDA's findings from its DSCSA Pilot, and what do they mean for pharma trading partners in late 2023?

May 25, 2023

This week, the FDA published its Final Program Report on its DSCSA Pilot Project Program, in which LSPedia and 19 other companies led industry projects designed to provide key insights into the technical capabilities of the supply chain and identify successful ways to implement the law’s requirements for tracking and tracing prescription drugs.

The program, which ran from May 2019-June 2020, had two specific objectives:

Identifying the system attributes needed to implement the requirements of section 582 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), particularly the requirement to utilize a product identifier for product tracing and verification purposes.

Assessing the ability of supply chain members to:

  • Satisfy the requirements of section 582 of the FD&C Act Identify, manage, and prevent the distribution of suspect and illegitimate products as defined in section 581(21) and 581(8)of the FD&C Act
  • Exchange product tracing information across the pharmaceutical distribution supply chain in an electronic and interoperable manner

The FDA’s DSCSA Pilot findings show how to stay on track for 2023

It’s worthwhile to read the full report, but we'll review some of the FDA’s main takeaways:

Interoperability: The FDA highlights the importance of “cooperation from trading partners and other stakeholders (e.g., solution providers)” in achieving interoperability, and adds that all parties “should consider how to balance supply chain transparency and security of the data.” This is a major priority, with some companies taking charge of deadline planning to ensure that their trading partners comply in time. As you likely know, it's also top of mind for LSPedia; in addition to seeking ways to streamline EPCIS onboarding, including using pre-tested connections, we’ve designed OneScan to enable quick and seamless communication between trading partners, with easy ways to track one another’s relevant data and receive real-time notifications when problems occur.

Standardization: The report argues 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 contends 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 says 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.”

Systems: The FDA calls attention to the importance of addressing IT issues, noting that this affects operational problems such as exceptions management. We agree – this is why we’ve focused so heavily on making Investigator capable of carrying out investigations via a secure, automated, cloud-based approach, reducing the need for internal IT resources to address every problem. Cloud technology also plays into the FDA’s finding that “system modification may result as a trading partner’s existing system is upgraded or combined with a new system component,” as OneScan’s cloud-based operation streamlines resource needs.

Processes: The authors caution readers to expect changes to some business and operational processes around using the product identifier for product tracing and verification. While this is certainly a reason to start your DSCSA implementation as soon as possible (if you haven’t yet done so), it’s important to note that OneScan can integrate with any business system, minimizing operational impacts.

Implementation Issues: The FDA advises 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 highlights the importance of training staff “to ensure smooth and efficient implementation and workflow integration.” LSPedia agrees with these points wholeheartedly – while we 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. It’s also a great idea to plan DSCSA training with LSPedia, as we offer the industry’s most comprehensive compliance training program for the new law.

LSPedia’s results for the FDA Pilot – and what’s next

In our pilot program, we collaborated with pharmaceutical companies to test LSPedia OneScan’s Verifier® Verification Router Service (VRS)solution for DSCSA compliance, in an effort that involved live verifications, notifications, and interoperability testing. After participants scanned barcodes on packages and homogenous cases, data elements were parsed from each barcode, and the solution successfully demonstrated product verification, product investigation, product status change, and interoperability. The pilot simulated verification of returned packages by having requestors scan live inventory at their distribution centers. As well, it simulated negative verifications with mock medication packages.

Our results showed the effectiveness of the VRS solution in achieving the requirements of the new law, showing that companies across the supply chain can use a live system to verify medications and manage exceptions in real time. And since the pilot program, LSPedia has processed more than 200,000 product verifications, protecting patients from counterfeit, suspect, and illegitimate products.

Participants used OneScan to meet the verification, notification, and interoperability obligations of companies operating under DSCSA, with end-to-end testing. Upon completion of the pilot, participants successfully achieved these objectives:

  • Verified returned products
  • Verified recalled products, simulated quarantine process
  • Verified suspect products and documented investigations into them
  • Conducted investigations using the unique product identifier and shared investigation data with trading partners
  • Upon determining that suspect products were illegitimate, manufacturers used OneScan to draft 3911 notifications
  • Performed interoperability by retrieving the serial product trace

Our work has only progressed since the pilot; our VRS technology has become even more advanced and convenient for users anywhere in the pharmaceutical supply chain, and is in use across the industry to protect patients from counterfeit or harmful drugs. As well, trading partners who work with LSPedia are secure in their regulatory standing, prepared for DSCSA far in advance of the November 27, 2023 final enforcement deadline.

LSPedia has also gone further to protect the industry and the patients who rely on it, holding its own cross-industry Exceptions Pilot this year to identify the types of problems with EPCIS transactions that can pose serious challenges – and, in many cases, threats – to every trading partner.

After spending months working directly with a number of participating companies and organizations on these issues, our next step is to release proposed solutions, procedures, and practices that will help the entire pharmaceutical industry prevent and mitigate potentially showstopping EPCIS exceptions that can incur massive costs in time and labor, and threaten patient safety.

Do you have questions about the FDA’s findings, or our own Exceptions Pilot? Get in touch today to find out more.