Prepare for 2023 DSCSA Compliance with HDA's Latest Industry Resources

July 07, 2022

In less than 18 months, the Drug Supply Chain Security Act (DSCSA) will reach its final milestone, culminating a 10-year implementation process across the healthcare supply chain. To help manufacturers and distributors prepare for interoperable data exchange, HDA, along with technical expertise from distributor- and manufacturer-member task force participants, has published new guidelines and other resources with the latest information and best practices.

Available as complimentary downloads from HDA’s website, these documents provide insights into best practices for bar coding healthcare products, handling exceptions as products move through the supply chain, data quality best practices for manufacturers and more.

HDA Guidelines for Bar Coding in the Pharmaceutical Supply Chain

The latest edition of HDA’s bar coding guidelines includes our most extensive updates in five years. These guidelines offer the latest specifications and industry best practices for bar coding and labeling healthcare products, detailing the use of GS1 system data structures and symbologies to comply with the DSCSA’s serialized product and data requirements. Information on shipping case bar code label format, inner packs, the latest FDA and USP recommendations and guidance on marking and placement of bar codes is included.

Exceptions Handling Guidelines for the DSCSA

As the supply chain works to implement DSCSA requirements, the mandatory interoperable exchange of serialized data will add significant complexity to sector operations, and there will be instances where there is a mismatch between data and product. “Exceptions” refers to those issues that may come up when product information fails to pass to authorized trading partners under the DSCSA. HDA members compiled best practices to manage damaged product, data, packaging and other issues that may cause exceptions.

Manufacturer Data Quality: Best Practices Considerations for DSCSA

Designed for manufacturers working to implement DSCSA requirements, this resource details what companies should consider when managing data quality as products move through the supply chain. The document offers guidance and best practices for integration with upstream partners, managing packaging operations, inventory management and distribution/3PL operations.

DSCSAEdu Website

In collaboration with six pharmacy groups, HDA launched a new virtual hub of resources and educational materials developed for dispensers preparing for DSCSA implementation. The website houses dozens of resources including checklists, podcasts and webinars, and it will continue to be updated as new materials become available. The site also provides an overview of DSCSA, key milestones and DSCSA’s definition of a dispenser.

As the industry approaches the final year to prepare for DSCSA compliance, it is more critical than ever for trading partners to finalize their plans and implement data exchange requirements. HDA will continue to develop resources and convene trading partners to ensure the supply chain successfully reaches this goal.

To provide further education, solutions and to help your company get on track for 2023, HDA will host a complimentary Traceability Webinar Series, launching later this summer. The series will feature DSCSA experts covering topics like the compliance timeline, implementation for dispensers, VRS and EPCIS. Check our events page next month for registration details — and be sure to share with your trading partners and customers.

Additionally, HDA will host the annual Traceability Seminar on October 12–14 in Washington, D.C. Join other supply chain professionals responsible for facilitating DSCSA compliance for educational sessions and strategic discussions. Learn more and register for the seminar on the event website.