FDA begins preparations for new NDC coding system

National Drug Code (NDC) numbers are used all over the health care industry, from e-prescribing to adverse event reporting. FDA held a meeting recently to discuss a new system, as NDC numbers are set to run out in the next decade or so.

National Drug Code (NDC) numbers are used all over the health care industry, from e-prescribing to adverse event reporting. FDA held a meeting recently to discuss a new system, as NDC numbers are set to run out in the next decade or so. Although the issue will not arise for several years, Janet Woodcock, director of FDA's Center for Drug Evaluation and Research, said that "it takes years and years once the standard is in place to change the system," and labeling and packaging may also have to change with a new system. Currently, the NDC is a 10-digit number with three segments to identify the company, the product, and the package size and type, via the labeler code, the product code, and the package code. FDA said it will begin assigning 6-digit labeler codes in about 15 years, once it runs out of the 5-digit labeler codes. The agency offered four different strategies to ease the transition; however, an Apotex representative offered its own proposal, urging the company to move to a 7-digital labeler code. Meanwhile, a Walgreens representative suggested that FDA wait to make changes until after 2023, when Drug Supply Chain and Security Act requirements are also coming.