DSCSA Exceptions

Pilot Program

LSPedia and collaborators carry out DSCSA exceptions pilot



LSPedia has launched a pilot program to develop improved solutions and processes for DSCSA exceptions management in the supply chain, joined by participants and observers from all across the prescription drug supply chain.  This program is 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. Such errors are already inevitable in DSCSA implementation, more so because EPCIS data exchanges are new to many trading partners. 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.

After November 27, 2023, data will need to accompany product every time it changes hands. This will create an explosion in EPCIS file exchanges, from 5,000 per day to 500,000 and beyond – and exceptions will increase right along with them.To prevent these disruptions, LSPediA is building on its leadership in exceptions management with an industry pilot program designed to foster deep understanding of new problem scenarios before they can occur widely, and discussing the solutions, procedures, and best practices that will keep prescription drugs moving through the supply chain.

Pilot Design

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

The group is compiling a comprehensive list of error scenarios and design methods to resolve them. From there, it will develop metrics 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


Qualified participants are manufacturers, wholesale distributors, dispensers, and healthcare providers, including both LSPediA customers and non-customers.Pilot members will meet twice monthly to discuss current outcomes, identify new exceptions, propose solutions to issues that have been discovered, and exchange ideas and practical business needs related to exceptions management. This group meets on Wednesdays at 2PM ET. The program is expected to conclude in May 2023.


Our DSCSA exceptions management pilot is a crucial step in ensuring compliance with the regulations because it brings together industry leaders, real EPCIS data, and effective resolutions. By testing and refining our solutions with actual data and feedback from industry leaders, we are able to develop a comprehensive and effective solution that helps companies maintain DSCSA compliance and improve the efficiency of their supply chain operations.

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Real Scenarios

Experience and resolve real-life scenarios created by the industry's leading companies.

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Real EPCIS Data

Get the full hands-on experience using real EPCIS data.

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Open Discussions with Industry Leaders

Gain insight into processes and best practices through open discussions with key industry leaders.

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Live Resolutions

The pilot program provides participants with  live EPCIS exceptions resolutions, giving them valuable insights into how to resolve real-world supply chain issues. This hands-on approach to testing and refining helps ensure that the resolutions will be effective, efficient, and easily implementable for companies of all sizes.

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Standard Operating Procedures

This pilot is designed to identify, discuss, and resolve various exceptions scenarios that are used to created Standard Operating Procedures. Participants will receive these SOPs at the conclusion of the pilot.


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Gain unique insights into exceptions management
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Voice your business' issues with DSCSA transaction data
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Learn about DSCSA compliance and serialization from top experts
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Participate in discussions on how to solve key data problems
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Exchange ideas and network with colleagues across the industry
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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