Farmington Hills, MI, April 16, 2019 – LSPediA Inc., a leading supply chain solution provider, announced today that FDA selected LSPediA to participate in the FDA DSCSA Pilot Project Program focusing on Verification, Notification, and Interoperability.
This pilot program is intended to assist the agency and members of the pharmaceutical distribution supply chain in the development of the interoperable electronic system to be established by 2023. The 2023 system has the potential to reduce diversion of drugs distributed domestically as well as help deter counterfeit drugs from entering the supply chain. The pilot program will be designed to explore issues related to utilizing the product identifier for product tracing, improving the technical capabilities of the supply chain, identifying the system attributes that are necessary to implement the requirements established under the DSCSA, and any other issues identified by FDA (see section 582(j)(2)(B) of the FD&C Act).
LSPediA’s pilot project is designed to identify the strategic points of the supply chain where a serialized drug product should be verified and traced to build a chain of custody. The pilot process includes end-to-end testing with participating trading partners performing verification and tracing transactions utilizing the unique product identifier as serialized products change ownership in the supply chain. The pilot will collect key performance data, identify challenges, and recommend best practices. Throughout the pilot project and upon completion, LSPediA will report the findings and recommendations to the FDA.
“As a technology leader in pharmaceutical serialization, LSPediA is honored to collaborate with the FDA and the industry, ” said Riya Cao, CEO of LSPediA. “This pilot project will help businesses comply with FDA regulations better and contribute to a more secure supply chain collectively.”
In addition, “LSPediA is well positioned to conduct a successful DSCSA Pilot,” added Michael Ventura, VP Solutions and Innovations for LSPediA. “Serialization offers a great opportunity for pharmaceutical companies large or small to transform their supply chain operations into the digital age. This FDA pilot will demonstrate a viable solution to the DSCSA verification, notification, and interoperability requirement. Beyond that is a clear roadmap to value beyond compliance in operations, customer service, and patient safety.”
Designed to mirror the real-world supply chain with end-to-end testing by the smallest and largest pharmaceutical trading partners, LSPediA welcomes your participation in the FDA DSCSA Pilot Program. To learn more about the pilot, please click here.
LSPediA is a leading supply chain software provider for the pharmaceutical industry. LSPediA’s serialization solution RxChain enables pharmaceutical manufacturers, wholesale distributors, dispensers to manage data, distribute products, and track inventory at the serialized level. LSPediA’s Verification Router Service enables authorized trading partners to authenticate serialized products, verify returns, and deter counterfeiting. To learn more, please call (248) 973-2008, email [email protected] or visit www.lspedia.com.