Farmington Hills, MI, March 20, 2019 – LSPediA LLC, a leading serialization supply chain solution provider, announced the submission of the DSCSA Pilot Project to the FDA focusing on Verification, Notification, and Interoperability.
FDA announced the DSCSA Pilot Project Program to implement section 582(j) of the FD&C Act. This program is intended to assist FDA 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 has developed an exceptionally cost-effective way to utilize the product identifier for verification that deters counterfeits through LSPediA’s Verification Router Service (VRS) Solution. In addition, the Healthcare Distribution Alliance (HDA) has established governance of the Router Service Network, and has piloted VRS with solution providers, wholesalers, and manufacturers. LSPediA is one of the original solution providers in the HDA pilot program and has performed more than 50,000 succesful verifications to date.
Recognizing that the Router Service Network and, more importantly, the technology and standards that enable the router service, can expand beyond verification and into product tracing and interoperability, LSPediA submits the request to participate in the FDA DSCSA pilot program for Verification/Notification and Interoperability. The results of the pilot will demonstrate that Router Service is a viable path to full DSCSA compliance and can be put in place by 2023 by trading partners.
“We applaud the FDA’s efforts in DSCSA implementation, including this pilot program,” said Riya Cao, CEO at LSPediA. “Our pilot is designed to verify and trace serialized drug products at strategic points of the supply chain to deter counterfeit, uncover diversions, and facilitate recalls. Utilizing granular serial numbers, the same processes that meet the DSCSA compliance rules promise even greater potential to drive value for every entity in the supply chain, including manufacturers, distributors, dispensers, and hospitals.
Ms. Cao added: “As an active member of the pharmaceutical industry, LSPediA is honored to contribute to a better supply chain that ultimately benefits all patients and their wellbeing.”
LSPediA is a leading supply chain software provider for the pharmaceutical industry. LSPediA’s serialization solution RxChain®, RxChain™ Mobile, and Verifier® VRS protect pharma companies against regulatory risks and improve supply chain efficiency. Pharmaceutical manufacturers, wholesale distributors, dispensers, and healthcare providers partner with LSPediA to manage serial data, distribute serialized drug products, verify the validity of the drug product. To learn more, please call (248) 973-2008, email [email protected], or visit www.lspedia.com.