DSCSA Exceptions

Pilot Program Results

LSPedia and collaborators carry out DSCSA exceptions pilot

About

In January 2023, LSPedia conducted a pilot program to develop improved solutions and processes for DSCSA exceptions management in the supply chain. The pilot program featured participants and observers from across the prescription drug supply chain. This program was designed to achieve system-agnostic, actionable findings on the complex data errors that can halt the flow of product any time it changes hands.

DSCSA FDA Exceptions Pilot
DSCSA Errors and Exceptions Pilot Calendar

Pilot Background

Exceptions are data errors that occur when a shipped product can’t be accepted due to incorrect data, missing data, missing product, or discrepancies with the shipment.  These errors can halt product movement, add complexity, and increase staff workloads, boosting labor and costs. The delays they cause can keep medicines from reaching patients.

Since November 2023, data needs to accompany regulated pharmaceutical products every time it changes hands. This led to an explosion in EPCIS file exchanges and exceptions increased right along with them. To prevent these disruptions, LSPedia collaborated across the industry, launched and led this pilot program designed to foster deep understanding of new problem scenarios before they occur widely, in order to define the solutions, procedures, and best practices to keep prescription drugs moving through the supply chain.

Pilot Design

This pilot provided agnostic exceptions solutions for the entire supply chain, along with targeted processes and procedures for different business types. It covered a range of issues with EPCIS data, data exchanges, and logistics, incorporating the exceptions categories found in HDA’s “Exceptions Guidelines for the DSCSA.” Which included product without data, data without product, packaging or labeling problems, and other discrepancies.

The group compiled a comprehensive list of error scenarios and design methods to resolve them. Metrics were developed to evaluate each method, reach consensus on how they should be applied, and recommend best practices.

DSCSA EPCIS exceptions pilot design
EPCIS Exceptions Pilot Timeline

Pilot Key Features

Our DSCSA exceptions management pilot was a crucial step in ensuring compliance with the regulations by bringing together industry leaders, real EPCIS data, and effective resolutions. By testing and refining solutions with actual data and input from industry leaders, pilot participants collaborated to develop a comprehensive and effective solution that helps companies maintain DSCSA compliance and improve the efficiency of their supply chain operations.

Pilot Results – Exceptional Exceptions Management Solution

LSPedia's Investigator is a module of its OneScan Suite that can cut the resolution time for an exception from days to minutes by automatically alerting users to EPCIS errors and guiding them through the resolution process enabling them to locate a problem before it can stop business. Its notifications include live hyperlinks allowing the point of contact to quickly view the issue and apply necessary fixes.

Investigator is now the industry's leading go-to exceptions management solution for the FDA’s Enhanced Supply Chain Security 2023 requirement, a mandate under the Drug Supply Chain Security Act (DSCSA). It manages the errors and failures that arise from new DSCSA transactions including EPCIS and VRS.

Explore Investigator

PILOT PARTICIPANTS

AmerisourceBergen Rite Aid DSCSACardinal Health DSCSAKuehne Nagel DSCSAAssociated Food Stores DSCSAHelsinn DSCSATopRx DSCSAKowa Pharmaceuticals DSCSASmith Drug Company DSCSAACI Healthcare DSCSASpartanNash DSCSAQCP DSCSAFresenius KabiTwoLabs Pharma ServicesKing & Spalding DSCSAWestminster DSCSAEnovachemSouth Pointe Pharma DSCSASchaltenbrand Solutions DSCSARxScan DSCSAMediriteBristol Myers Squibb DSCSAProficientRxNextgen Pharmaceuticals
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