For years, the FDA has been concerned about running out of numbers for the National Drug Code (NDC) to use to identify drug products. They estimate that their runway for exhausting all NDC number combinations may come in 10-15 years.

Well, FDA published a proposed rule entitled Revising the National Drug Code Format and Drug Label Barcode Requirements in the July 25, 2022 edition of the Federal Register (FR) (here) to address this problem and the Agency has given industry plenty of time for the changes to be made after the final rule publishes. The FDA states that “[T]his action, if finalized, will standardize the format of all NDCs. Specifically, all NDCs will be required to be 12 digits in length with three (3) distinct segments and one (1) uniform format. The first segment is the labeler code and will be six (6) digits, the second segment is the product code and will be four (4) digits, and the third segment is the package code and will be two (2) digits.”  This should solve the problem until long after all of us are gone, but, in the meantime, it will require lots of effort in label changes after the effective date of the final rule (which, admittedly, could be quite a way away in the future)!

In addition, the “FDA is also proposing to revise the drug barcode label requirements to allow the use of either linear or nonlinear barcodes, so long as the barcode meets the prescribed standards.”

On the effective date of the final rule, firms should have systems in place to handle the new 12-digit numbers.  But don’t worry- the Agency is planning to make the effective date of the rule five (5) years after the final rule’s publication.  Another piece of information that may make industry breathe a bit easier is that for all existing NDC number issued before the effective date, the FDA will automatically add two (2) zeros to the first segment (see further explanation below) of the NDC number and industry will only have to revise labeling and won’t have to relist or change existing NDC numbers otherwise. FDA will allow a 3-year period after the effective date of the final rule to permit firms that have existing NDC numbers to transition labeling to add the two (2) leading zeros (again see further explanation below).  FDA will not object to firms continuing to use the 10-digit NDC number during the 3-year transition period but should try to make changes as soon as possible and should have systems in place to handle both 10- and 12-digit numbers during the transition period. The only thing that could shorten the 5-year delay of the effective date is if, between the proposed rule and final rule, the FDA is so concerned they will run out of 5-digit labeler code numbers that they may decide to shorten the effective date.  So, make your comments early to avoid this one catch!

The proposed rule provides a history of the NDC number system, the current regulatory framework, the need for the regulation, and the regulatory history that formed the basis for the current proposed rule. To explain how the Agency will implement this number change for firms that already have assigned NDA numbers, the Agency explains – “if the firm currently uses the 5-3-2 format, it would additionally need to convert the existing product code from a 3-digit code to a 4-digit code by adding a leading zero to achieve the 6-4-2 format. If the firm currently uses the 5-4-1 format, it would not need to convert the existing product code because it is already four digits. However, it still would need to convert its labeler code to six digits and would need to request a unique package code.”

There is a lot of important and good information in this proposed rule. My advice to firms is to get your label and IT folks involved early to avoid the definition of time as “time is what keeps one darn thing after another from becoming every damn thing at once” from rearing its ugly head!