HDA Addresses DSCSA Data-Related Challenges In Healthcare Packaging Op-Ed
February 27, 2023
The Drug Supply Chain Security Act (DSCSA), which will require trading partners to provide transaction data along with serialized product upon a change of ownership, goes into effect on November 27, 2023. With the end of the 10-year-implementation fast approaching and significant work remaining for the supply chain, HDA’s Anita Ducca, Senior Vice President, Regulatory Affairs, and Elizabeth Gallenagh, General Counsel and Senior Vice President, Supply Chain Integrity co-authored a piece for Healthcare Packaging that examines the progress toward, challenges impacting and recommendations and requirements for full implementation. In the piece, Ducca and Gallenagh explain that while HDA’s latest EPCIS Implementation Benchmarking Survey (Third Quarter, 2022) signaled progress is being made on important connectivity tasks, the supply chain is not where it should be given the long runway required for onboarding and working through data challenges.
There is also discussion of recommendations and requests made by HDA to the Food and Drug Administration to ease the transition for trading partners. These include requesting a stabilization period and urging the agency to avoid exercising broad enforcement discretion for manufacturers and repackagers’ DSCSA requirements and provide exemptions for companies on a case-by-case basis.
Read the full column on Healthcare Packaging’s website to learn more.