The United States Food and Drug Administration (FDA) has set a public hearing and an opportunity for public comment regarding the future format of the National Drug Code (NDC). An NDC is a unique ten-digit identifier, split into three segments, assigned to all drugs in United States commercial distribution. An NDC is proposed by companies and then assigned by the FDA through the drug listing process. Currently, formats for the NDC sequence are 4-4-2, 5-4-1, and 5-3-2.
The NDC for each listed drug in the United States is a unique 10-digit, 3-segment number. The 3 segments of NDC include the labeler code, product code, and package code. A labeler code is a unique 4-, 5-, or (in the future) 6-digit number assigned by FDA that identifies the manufacturer, repacker, relabeler, or private label distributor of the drug. The second segment, the product code, identifies a specific strength, dosage form, and formulation of a drug manufactured, repackaged, relabeled, or distributed by the labeler. The third segment, the package code, identifies package sizes and types. Different package codes only differentiate between different quantitative and qualitative attributes of the product packaging. Both the product and package codes are proposed by persons submitting drug listing information. FDA will assign a proposed NDC if it has not been used previously, is not currently in use, and has not been reserved for future assignment to a different product.
Based on current assignment rates, FDA anticipates that it will run out of 5-digit labeler codes in approximately 15 years. FDA will begin assigning 6-digit labeler codes at some point in the future due to exhaustion of 5-digit labeler codes. Moving up to 6-digit labeler codes will expand NDCs to 11 digits and, per regulation, allows for two additional NDC configurations: 6-3-2 and 6-4-1, for a total of five possible NDC configurations (including the three 10-digit NDC configurations).
Recognizing that a change to NDC length and/or format will be necessary when the FDA runs out of 5-digit labeler codes (the first segment in the identifier), the FDA had previously made plans to begin assigning six-digit labeler codes. However, the FDA acknowledges that some stakeholders expressed an interest in FDA moving to a single, standard format for NDCs and announced that it would initiate a public discussion of future formatting options. As the FDA understands any change to the format or length of the NDC will have an impact on the health system, the agency is holding a public hearing to receive input from stakeholders on how to maximize the benefit and minimize the impact in advance of any changes.
During the hearing and the public comment period, the FDA is seeking information on: the impact of transitioning from a 5-digit labeler code to a 6-digit labeler code, including the business, economic, information technology, and medical/clinical practice impacts, and its impact on the safety and security of drug products; issues associated with the current lack of NDC uniformity in the marketplace; what the FDA should consider as it explores any further changes or expansion to the format or length of the NDC; and how to best transition to a new format for the NDC.
The hearing is set to take place on November 5, 2018, from 8:30 am to 5:00 pm, at the FDA White Oak Campus. If you are interested in attending, you can register here. Registration must be received by October 15, 2018. The hearing will also be webcast live here. Electronic or written comments must be submitted before January 5, 2019.