Industry builds on FDA plans for expansion of national drug code

FDA's August 2018 notice announcing an expected need to expand the National Drug Code (NDC) format within 15 years has elicited a variety of industry feedback.

FDA's August 2018 notice announcing an expected need to expand the National Drug Code (NDC) format within 15 years has elicited a variety of industry feedback. Commenters cited concerns including struggles to meet deadlines from the Drug Supply Chain Security Act (DSCA), the link between NDC and the Globe Trade Item Number (GTIN), the amount of time and resources needed to make the transition, and unintended supply disruptions. Other commenters congratulated FDA for its efforts to engage stakeholders early as it considers different options for implementing a new NDC format, and several expressed support for one of FDA's four proposed approaches that would allow for harmonizing a standard configuration for all NDCs and converting existing NDCs with new leading zeros. The problem with transitioning to a new NDC format while working to comply with DSCA requirements relates to these already being implemented using the current format, which relies on 5-digit labeler codes. With FDA's proposal to begin issuing 6-digit labeler codes as it runs out of 5-digit labeler codes within the next 10–15 years, the NDC would be expanded from the current 10 to 11 digits. PhRMA senior directors Ryan Kaat and Olivia Shopshear called on FDA to delay announcing implementation of a new format until after a November 27, 2023 DSCSA deadline, citing the significant amount of time and resources needed to revise production and packaging systems.