TLDR DSCSA | April 2025 🐣
The most interesting DSCSA stories and news for the month of April.
Learn about the latest milestones, tools, and insights driving DSCSA progress in this month’s TLDR DSCSA newsletter. Highlights include updates from the PDG-FDA Town Hall showing significant strides in serialized data readiness, the launch of the EXODUS migration tool to support EPCIS compliance, and DataX's product enhancements. Dive into why exception management is central to compliance, spotlight Movilitas.Cloud’s VRS certification win, and explore the importance of data visibility for pharmacies.
Plus current job openings in DSCSA compliance.
Thanks for reading,
Daniel Kraciun | Chief Marketing Officer @ Trust.med
Submissions: dkraciun@trust.med
PDG Townhall: DSCSA Implementation Progress
Manufacturers Exemption Countdown.
TLDR ⚡ : Manufacturers polled are largely on track for the May 27, 2025 exemption sunset—more than 85 % of those surveyed now ship ≥95 % of their product with serialized transaction information (TI). Wholesale distributors show the biggest leap, jumping from 4 % to 80 % of firms that receive complete TI from ≥80 % of suppliers. However, these figures come from a relatively small survey and may not reflect the full market picture.
The next six months should focus on stress-testing exception-handling workflows, tightening feedback loops, and helping late adopters close the last-mile data-quality gap.
The meeting recording, summary, and survey are available at the link above.
EXODUS Tool Enables Seamless Migration to DSCSA Compliant EPCIS Systems
TLDR ⚡: The EXODUS tool empowers pharmaceutical companies to migrate from legacy serialization formats to modern, DSCSA-aligned EPCIS systems. By automating data extraction, conversion, and validation, EXODUS improves interoperability, enhances exception handling, and restores full ownership and control of serialization data—supporting a more compliant, flexible, and efficient supply chain.
Author: ANKHERO
DataX DSCSA Spring Product Update
TLDR ⚡: The update includes unlimited inbound and outbound EPCIS data exchange connections, EPCIS file validation with a custom rules engine, advanced reporting through ATLAS, and intelligent routing for drop-ship orders. These enhancements are available at no additional cost to existing users.
Author: Trust.med
Exception Management: The Missing Link in DSCSA Compliance
TLDR ⚡: A new article in the International Journal of Drug Regulatory Affairs emphasizes the critical role of exception management in achieving DSCSA compliance. As EPCIS file complexity increases, so do the risks of data mismatches and aggregation errors that can lead to product quarantines and regulatory reporting. Author Gaurang Bhavsar outlines how pharmaceutical companies must implement structured exception handling procedures, investigate root causes, and document resolutions to maintain traceability and ensure supply chain continuity.
Author: Gaurang Bhavsar, MS, RAC
Movilitas.Cloud Earns Gateway Certified™ Accreditation for VRS Compliance
TLDR ⚡: Movilitas.Cloud has become the first solution provider to achieve Level 1 and Level 2 Gateway Certified™ accreditation for its VRS Verify™ product. This independent validation confirms the system’s ability to accurately verify saleable returns under DSCSA, a key requirement for pharmaceutical trading partners.
Author: Gateway Checker
Why Visibility Into DSCSA Readiness Data Is Key to Compliance
TLDR ⚡: As DSCSA enforcement ramps up, pharmacies must shift from passive compliance to active readiness by tracking their own and their partners’ data preparedness. This article emphasizes the need for accurate serialized data (ASTI), real-time visibility, and collaborative problem-solving across the supply chain. With potential disruptions still looming due to missing or inaccurate data, pharmacies are urged to develop readiness strategies.
Author: Rob DeWig
DSCSA Job Openings 💼
DSCSA Compliance Manager
Company: Planet Pharma
DSCSA / Serialization Analyst
Company: Envision Pharma Group