Longer National Drug Code For Seamlessness Proposed By FDA

All labelling pertaining to the products that carry the national drug code will have to be updated if in case the FDA finalises its proposed policy to expand the numbers from 10 to 12 digits. There will be some cases where a label will be required to allow more space for the code. The aim of the proposed rule which is revising the National Drug Code Format and drug level barcode requirements, is to standardise the NDC format, expand the available code pool, and also push for an increase in the number of barcodes that are acceptable.

Lengthening of the codes is essential since the supply of the five-digit labeller code will run out in a matter of 10–15 years.

The rule that is proposed specifies that a 12-digit NDC includes three segments, besides a 6-digit labeller code, 2-digit package code, and 4-digit product code. The effective date is most likely going to be 5 years after the publication of the final rule, which will be followed by a 3-year transition time so as to convert the existing 10-digit code to 12 digits. During this time, all the stakeholders involved will have to run the systems that are capable of taking care of both 10- and 12-digit NDCs. ¹

The code change will also have to have employee trainings and an updated software. As per the estimates made by the FDA, this change is going to cost the industry anything between $43.1 million and $136.3 million. ²

Numerous commentors have agreed to the fact to lengthen the NDC but at the same time have concerns over the timeline as well as the number of stakeholders who will rely on the NDC, besides packaging, system change, and also software and cost projections.

If it is finalized, then the change will be noticed across the supply chain. Because of the number of systems and parties as well as the processes that would be affected, the GS1 US compared the impact to the Y2K transition in 2000. As per GS1, there are majorly three categories of systems which will get impacted by NDC format change namely barcoding systems, the organizational interfaces and the existing system used within the industry. The industry will not be able to use the linear UPC barcode because of the increased length to 12 digits. This will have repercussions, as there will then be a wider demand to use the 2D DataMatrix barcode within a certain space.

The director of sales and marketing of one of the companies that specialises in pharmaceutical contract packaging says that the logistics will have to be managed in order to ensure that there is no disruption when it comes to the supply chain. Also, the potential, as far as supply chain disruption is concerned, isn’t just limited to the presence of pharmaceutical products.