By Eric Foxman, AAHP Secretary
FDA has published a proposal that will change the required National Drug Code (NDC) format from 10 to 12 digits. Once finalized, all NDC holders would be required to convert to the new format. Because of the significant burden this may entail, FDA is proposing the effective date be five years after the final rule is published.
The proposed rule says regulations would be amended to adopt a uniform, 12-digit format for NDC. While NDCs will continue to consist of three segments (the labeler, product, and package codes), the proposal will organize the format as follows: six-digit labeler code, four-digit product code, and two-digit package code.
The proposal will also provide flexibility on the type of barcode used on the label of a drug product. Either linear or nonlinear barcodes would be permitted, so long as the barcode meets one of the prescribed standards in Sec. 201.25 (21 CFR 201.25).
As proposed, once the final rule is in effect, FDA would begin assigning new NDCs in the uniform, 12-digit format. All existing 10-digit NDCs would be required to convert to the new 12-digit NDC format. All stakeholders that use FDA-assigned NDCs would need to have systems capable of handling the new, uniform, 12-digit NDC on the effective date of the final rule. However, FDA is proposing the effective date of the final rule be delayed for five years following publication; this will allow stakeholders time to develop and implement such systems.
In addition, FDA is proposing a three-year transition period following the effective date of the final rule. During the transition period, firms that use 10-digit NDCs assigned prior to the effective date on product labeling should begin updating their labeling to replace the 10-digit NDCs with the new 12- digit NDCs. This should be accomplished by adding leading zeros to the labeler, product, and/or package code segments as needed, and should be done as soon as possible.
To aid with the transition, FDA does not intend to object to continued use of such 10-digit NDCs on the labeling of products remaining in interstate commerce during the three-year transition period after the effective date of the final rule. The purpose of the transition period is to mitigate the potential costs associated with reprinting labels for these products. Therefore, during this proposed transition period, stakeholders should ensure that their systems are capable of handling both 10-digit NDCs and 12-digit NDCs.
The AAHP will continue to monitor this proposal and inform its members of developments as they occur. However, companies are strongly encouraged to read the proposed rule and stay current with changes while already thinking about, and planning for, steps necessary to remain in compliance when the final rule becomes effective.