Learning Tracks

Effective March 7, 2033, FDA’s final rule revising the National Drug Code format and barcode requirements will establish a uniform 12-digit NDC in a 6-4-2 configuration. This presentation will walk attendees through the regulatory rationale behind the rule, the evidentiary record that supported it, and the stakeholder engagement and outreach strategy FDA employed to inform industry, healthcare partners, and government stakeholders. It will also cover the technical requirements of the rule — including updated barcode provisions permitting both linear and nonlinear formats conforming to internationally recognized standards — and how the 12-digit NDC integrates with existing Drug Supply Chain Security Act (DSCSA) requirements, enabling a single 2D data matrix barcode to satisfy both mandates. Attendees will leave with a clear understanding of FDA’s intent, the key milestones from the March 2033 effective date through the March 2036 end of the transition period, and what the agency expects from regulated industry during and after the transition.

Julian Chun, PharmD, MBA, RAC
Lead Public Health Analyst, Drug Registration and Listing, OUDLC, OC, CDER, FDA