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The change would impact every package and hundreds of systems.
All product labeling that carries the National Drug Code (NDC) will need to be updated if FDA finalizes its proposed rule to expand the number from 10 to 12 digits. In some cases, labels also may need to allow more space for the code. The goals for the proposed rule, Revising the National Drug Code Format and Drug Label Barcode Requirements (/docket/FDA-2021-N-1351), are to standardize the format of the NDC, expand the pool of available codes, and increase the number of acceptable barcodes. Lengthening the code is necessary because the supply of five-digit labeler codes will be exhausted in 10 to 15 years. Comments on the proposed rule were due by Nov. 22, 2022 (1).
The proposed rule specifies a 12-digit NDC with three segments, a six-digit labeler code, a four-digit product code, and a two-digit package code. The effective date would be five years after publication of the final rule followed by a three-year transition period to convert existing 10-digit NDCs to 12 digits. During this period, all stakeholders would need to run systems that are capable of handling both 10- and 12-digit NDCs (1). The code change also would require updated software and employee training. FDA estimates the change will cost the industry between $43.1 and $136.3 million (2).
Many commenters agreed with the need to lengthen the NDC but raised concerns about the timeline; the number of stakeholders that rely on the NDC; the scope of the packaging, software, and system changes required; cost projections; the potential for confusion and misdosing as the longer codes are adopted; impact on the Global Trade Item Number (GTIN) code used for serialization; and the advisability of going beyond 12 digits to delay the next depletion of numbers (1). “Expanding the proposed new NDC code length to 13 digits, in a single uniform, 7-4-2 format, for example, may provide a more enduring solution,” noted Ryan Kaat, general counsel of Pharmaceutical Research and Manufacturers of America (PhRMA), in its comments (3).
If finalized, the change will reverberate across the value chain. Due to the number of parties, systems, and processes affected, GS1 US likened the impact of the change to an industry-specific Y2K (Year 2000), which necessitated updating systems to ensure a successful transition from 1999 to 2000. GS1 US noted, “There are three categories of systems impacted by the change in the NDC format: the barcoding system; the systems used by organizations within the healthcare industry; and the interfaces between organizations. The industry will no longer be able to use the linear UPC barcode due to the increased length of the NDC to 12 digits as it exceeds the maximum character allowance … This will result in a greater need to use the 2D DataMatrix barcode to carry the five product data elements (with capacity for others if necessary) within a certain space (4).”
Josh Goolcharan, director of sales and marketing for Reed-Lane, a privately held company specializing in pharmaceutical contract packaging, explains, “The logistics for implementing the changes will need to be managed to ensure there are no disruptions to the supply chain. Contract packagers like Reed-Lane will need to work closely with … their customers to see that required artwork revisions are implemented accurately and efficiently, ensuring that customer inventory levels are maintained.”
He adds, “Any of our in-house print systems currently printing either human-readable or barcode-based NDC numbers will need to be reviewed to determine compatibility with the revised format. These assessments include whether a software revision is required and whether a print system will need to be replaced to meet the new requirement.”
The potential for supply chain disruption is not limited to the availability of pharmaceutical products. Goolcharan notes, “As all packaging operations will be meeting the same implementation deadlines, the vendors that support the production of printed packaging components and serialized packaging lines may face a surge of orders, resulting in long lead times to meet the demand for the changes associated with the revised NDC format.”
Currently, each serialized package level is assigned a GTIN-14 number, and the NDC number is part of this GTIN number. The GTIN is printed in a human-readable format and included in the symbology printed on serialized packages. This scenario does not accommodate a 12-digit NDC. According to GS1 US, “The new NDC format amplifies the need to associate an NDC with a GTIN to uniquely identify a product at every packaging hierarchy. While the NDC can no longer be embedded in the product GTIN, the association of a GTIN to an NDC remains critical. The association of the GTIN to an NDC is achieved by defining NDC as AI (Application Identifier) (715) (4).”
Goolcharan observes, “Additional real estate on some packaging components may be required to accommodate expansions of printed information stemming from the revised NDC format.” In addition, he says, “…any required revisions to the software on serialized lines, or when transferring serialized data, would need to be developed, installed, and qualified so the serialized process can cooperate with the revised NDC format.”
Enterprise Resource Planning
Electronic Batch Record
Material Resource Planning
Contract and Pricing
Government Rebate (Medicaid)
Payer and Reimbursement
Fee for Service
Product Returns Management
Patient Assistance Programs
Structured Product Labeling
Inpatient/Long-term Care Facilities
Drug Data Compendia
Federal Government Agencies
State Government Agencies
Source: GS1 US (4)
1. FDA. Revising the National Drug Code Format and Drug Label Barcode Requirements. Proposed Rule, Federal Register, 87 FR 44038, 44038-44048.
2. FDA. Revising the National Drug Code Format and Drug Label Barcode Requirements. Preliminary Regulatory Impact Analysis,July 27, 2022.
3. Kaat, R. Re: Docket No. FDA-2021-N-1351; Revising the National Drug Code Format and Drug Label Barcode Requirements, comment from ThePharmaceutical Research and Manufacturers of America. Nov. 23, 2022.
4. GS1 US. GS1 US Comment to the United States Department Food & Drug Administration Regarding: Revising the National Drug Code Format and Drug Label Barcode Requirements Docket No. U.S. FDA-2021-N-1351, Nov. 23, 2022.