FDA Proposes Rule to Update National Drug Code Format

By Krystal Spickler, program manager, Supply Chain team, UL Solutions 

On July 25, 2022, the United States Food and Drug Administration (FDA) published a proposed rule to update the existing 10-digit National Drug Code (NDC) format to a 12-digit universal format. This change would standardize the format across industries to allow adoption of a common NDC by all stakeholders. It would also increase the quantity of available labeler codes prior to the depletion of FDA’s estimated 10 to 15 year supply.  

NDCs are an FDA-standardized number used to uniquely identify drug products marketed in the US. Examples of stakeholder departments who may use NDCs include clinics, healthcare practitioners, drug manufacturers, insurers, pharmacies, and various governmental agencies.  

21 CFR Part 207 currently allows a first segment labeler code assigned by the FDA to consist of 4, 5, or 6 digits. The second segment is the product code which may consist of 3 or 4 digits. The third segment is the package code, which identifies the package size and type of drug and consists of 1 or 2 digits. The updated format permits a 6 digit labeler code, 4 digit product code, and 2 digit package code, i.e. NDC 012345-6789-00. The proposed rule does not require registrants to resubmit information for existing drug listing files. Instead, FDA will convert them by adding leading zeros on the effective date. After that date, FDA will also publish both NDC formats to minimize confusion and risk. 

The FDA has also recognized from early comments that a longer NDC may pose challenges to operations using the GTIN-14 standard to include the NDC in label barcodes. These challenges may require new standards to implement the updates. As such, FDA is also proposing to revise § 201.25(c) permitting barcodes to be linear or non-linear provided that other requirements are met. 

FDA proposes an effective date 5 years from the final rule’s publication. Additionally, the proposal provides a 3-year transition period following the effective date. 

Comment acceptance closed Nov. 22, 2022. Feedback from stakeholders included requests for an extended 5-year transition period and clarification on impact to GTIN, among others. 

References

Federal Register :: Revising the National Drug Code Format and Drug Label Barcode Requirements
FDA 21 CFR 207.33