The FDA DSCSA Pilot Program

The FDA DSCSA Pilot Program

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LSPediA Confirms Participation in FDA’s
DSCSA Pilot Project Program

LSPediA Inc. has 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 LSPediA accepted into FDA DSCSA Pilot Project Program 2023.

LSPediA Pilot Background

The FDA is establishing 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 and 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 necessary to implement the DSCSA requirements, and any other issues identified by the FDA (see section 582(j)(2)(B) of the FD&C Act).

LSPediA Pilot Goals

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. The Healthcare Distribution Alliance (HDA) already has piloted VRS technology with solution providers, wholesalers, and manufacturers. LSPediA is one of the first solution providers participating in the HDA pilot, performing more than 70,000 verifications to date.

Early on, LSPediA recognized that Verification Router Service, and more importantly, the technology that enables the router service, has the capacity to 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 the Router Service is a viable path to full DSCSA compliance and can be put in place prior to 2023 by trading partners.

Pilot Design

LSPediA has designed a pilot program that involves both small and large companies.  LSPediA plans to start the pilot program on July 1, 2019 and complete it by Oct. 1. 9, 2019. We are committed to start the pilot project within four months or less of receiving the FDA’s acceptance letter.

LSPediA proposes using the Verification Router Service to meet the verification, notification, and interoperability obligations of companies operating under the DSCSA. The scope of the pilot project includes end-to-end testing with participating trading partners.

The goals of this pilot project are:

  1. Identify strategic points in the supply chain where product verifications could occur, building a chain of custody;
  2. Verify serial numbers on returned product, allowing it to be resold;
  3. Verify suspect products to deter counterfeiting;
  4. Notify the FDA and trading partners of suspect and illegitimate product with FDA reporting.

Pilot Outcome Reporting

LSPediA will manage the pilot project and report key performance data to the FDA. LSPediA also will provide VRS guidance and subject matter expertise to all functional areas as needed and will proactively identify risks and assist in risk mitigation.

Focus Area Verification Notification Interoperable
Product Tracing
KPIs Verification response time – wholesalers Time to prepare and send a 3911 notification Time to obtain product tracing information
Verification response time – dispensers Time to update a 3911 notification Time to gather product tracing information to support an investigation for a suspect or illegitimate product, or a recall
Percentage of items that are successfully verified vs. those that were targeted for verification Time to clear a 3911 notification Time to retrieve product tracing for a direct purchase
Number of connections/queries needed to gather product tracing information in response to a verification or notification request. Time to retrieve product tracing for an indirect purchase
Security Security
Trading Partner access Trading Partner access
Risk analysis Risk analysis Risk analysis

Value

The pilot will collect key performance data, identify challenges, and recommend best practices.

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 findings and recommendations to the FDA.

History of the FDA DSCSA Pilot Project Program

The FDA announced the DSCSA Pilot Project Program in February, as a way 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.

Apply to Work in LSPediA’s FDA DSCSA Pilot Project Program

LSPediA encourages pharma companies large or small to join this pilot project and work collaboratively toward solutions that meet the requirements for sales returns, notification, and interoperability.

To apply for LSPediA’s FDA pilot project, please click here.

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