FDA Announces Proposed Rule Updating the Current 10-Digit NDC Format to a 12-Digit Standardized Format

On July 22, 2022, the FDA announced a proposed rule changing the current 10-digit NDC format to a 12-digit standardized format. This is due to the limited number of new 5-digit Labeler Codes estimated to run out in the next 10 to 15 years. Current regulations require a 5-digit Labeler Code, 3 to 4-digit Product Code, and 1 to 2-digit Package Code. The proposed changes consist of a 6-digit Labeler Code, 4-digit Product Code, and 2-digit Package Code which allow for the addition of leading zeroes to current 10-digit NDCs for standardization. The FDA held a public hearing on November 5, 2018, with stakeholders and of the four options presented, the 12-digit conversion received the most positive feedback. Additionally, the benefit of the 12-digit solution is the creation of one standard configuration for current and new NDCs, allowing for a smoother transition and a decrease in medication errors and confusion caused by the change in NDC format.

More importantly, when is this change set to occur? The FDA has not finalized the proposed rule; however, it has set transition guidelines to provide stakeholders time to develop and implement the changes needed for the conversion to the 12-digit format. The FDA has proposed an effective date to begin five years after the publication of the final rule. The FDA will then begin releasing new 12-digit NDCs, converting existing NDCs with the addition of leading zeroes, require new drug listings to be submitted in the 12-digit format, and require certain stakeholders to have systems in place to accommodate the 12-digit format.

The FDA has also proposed a three-year transition period after the effective date to allow for the required product labeling changes. This includes allowing the continued use of 10-digit NDCs on the labeling for products assigned a 10-digit NDC prior to the effective date. The FDA will continue to maintain and publish both the 10-digit and 12-digit NDC formats during the transition period to help minimize potential medication errors and confusion caused by the change in format. Furthermore, the FDA is proposing to revise the drug barcode label requirements and additional regulations to account for future advances in technology that would otherwise require additional revisions.

What does this mean for my business and what do I need to do to prepare? The new NDC format will require software updates, employee training, and a general understanding of the proposed rule. This change will be going into effect and quickly implementing changes will ease the transition and mitigate potential medication errors and confusion. Contact Boesen and Snow Law today for assistance in assessing and implementing the changes needed to accommodate the updated NDC format.