GS1 Standards Archives - rfxcel.com
EnglishFrenchGermanItalianPortugueseRussianSpanish

FDA National Drug Code: Proposed Format Changes & Industry Impact

If you follow our blog (and we know you do), you know that pharma stakeholders will have to verify all products at the individual package level when the Drug Supply Chain Security Act (DSCSA) goes into full effect about 1 year from now. The FDA National Drug Code, or NDC, is integral to this requirement.

At some point, however, the FDA realized that it was “running out of” National Drug Codes. One reason was the pandemic, which the Agency said “significantly increased the rate at which NDC codes were issued.” In response, on July 22 it published a proposed rule, “Revising the National Drug Code Format and Drug Label Barcode Requirements.”

What does this mean? How will a new FDA National Drug Code format affect the pharma industry? Let’s take a look.

What is the FDA National Drug Code?

The FDA National Drug Code is the Agency’s “standard for uniquely identifying drugs marketed in the United States.” The codes are usually found on product labeling and might be part of the universal product code (UPC). Today, National Drug Codes comprise 10 digits in three segments:

      1. Labeler code (4 or 5 digits), which identifies the labeler. The FDA defines a labeler as “any firm that manufactures (including repackers or relabelers), or distributes (under its own name) the drug.” The FDA assigns labeler codes.
      2. Product code (3 or 4 digits), which identifies strength, dosage form, and formulation for a particular firm. Firms assign product codes.
      3. Packaging code (1 or 2 digits), which identifies the package size and type. Firms assign packaging codes.

National Drug Code formats are commonly referred to as “5-4-1,” “5-4-2” (HIPAA standard), “5-3-2,” or “4-4-2” depending on how many digits each segment has. The illustration below is adapted from an FDA graphic depicting the current format.

Current FDA National Drug Code NDC Format

The Proposed Changes to the FDA National Drug Code

The proposed FDA National Drug Code would have a “uniform” 12-digit, “6-4-2” format, as illustrated below. The Agency says this “would facilitate the adoption of a single NDC format by all stakeholders [and] eliminate the need to convert NDCs from one of FDA’s prescribed formats to a different standardized format used by other sectors of the healthcare industry (e.g., healthcare providers and payors).”

Proposed Changes to FDA National Drug Code NDC

When and how will the change be rolled out?

The FDA proposes an effective date 5 years after the final rule is published “to allow stakeholders time to develop and implement changes to their systems.” Pharma stakeholders that use FDA-assigned codes will need to have systems in place to handle the new format by the effective date.

The Agency would begin assigning new 12-digit National Drug Codes in the 6-4-2 format on the effective date. Drug listing files submitted on or after the effective date would also have to use the new 6-4-2 format.

However, “to reduce the burden on registrants,” the FDA says it won’t require companies to resubmit all of their existing drug listing files; instead, the Agency itself would convert the existing codes “by adding leading zeros to the appropriate segments.” For example:

All FDA National Drug Code NDC

And though the Agency’s proposing a 3-year labeling transition period from the effective date, it’s encouraging manufacturers and distributors to start using the new National Drug Codes as early as possible. Still, during this 3-year period the FDA “does not intend to object to the continued use of 10-digit NDCs on the labeling of products that were assigned a 10-digit NDC prior to the effective date.”

Impact on product labeling

Product labeling will have to be updated with the uniform 12-digit FDA National Drug Code. To make this easier for stakeholders, the Agency proposes revising requirements to allow linear or nonlinear barcodes — as long as they meet mandated standards.

The FDA says it’s also looking into revising 21 CFR 201.25(c), “Bar code label requirements,” to “accommodate potential advances in technologies and standards development by allowing the use of unspecified automatic identification and data capture (AIDC) formats other than linear or non-linear barcodes … without the need to revise the regulation again.”

Industry reaction

These proposed changes to the FDA National Drug Code would affect manufacturers of human and animal drugs, insurers/payors, wholesale distributors, drug databanks, pharmacies, hospitals, small clinics and healthcare practitioners, dentist offices, prisons, nursing care facilities, importers, federal agencies using the National Drug Code, state and local governments, and other supply chain stakeholders that use FDA National Drug Codes.

The pharma industry has known for at least 4 years that the FDA was concerned about running out of codes and was thinking about proposing changes. The Agency held a public hearing on Nov. 5, 2018, “to receive input from stakeholders on how to maximize the benefit and minimize this impact well in advance of any forthcoming change.” Four options were presented at this hearing:

      • Option A: Use 5-digit labeler codes until they run out, then adopt a 6-digit labeler code
      • Option B: Start using 6-digit labeler codes on a designated date
      • Option C: Change to an 11-digit format, then a 12-digit format, when the 5 -digit label codes are gone
      • Option D: Adopt the 12-digit format before the 5-digit labeler codes are gone.

Most comments from industry supported Option D. “Comments were in favor of FDA’s adoption of a single standardized format that could be used by all stakeholders,” the Agency reported. “The majority of the commenters were in favor of FDA establishing a certain date when stakeholders would be required to have systems capable of handling the new format.”

However, industry leaders raised concerns in their public comments. The Healthcare Distribution Alliance (HDA) noted its “agreement with those speaking at the public meeting that … Options, A, B and C, are infeasible. Some of them, for example, would negatively impact bar code technology and interoperability, and others would perpetuate, or even exacerbate the confusion created by the current multiple formats, by adding even more formats. These three Options could also result in creating duplicate NDCs.”

GS1, with input from its New NDC Format Workgroup, advocated for Option D, including implementing “a standards-based format for NDC” (i.e., using a Global Trade Item Number, or GTIN; see below). It also noted concerns, saying this option had “cons,” including its impact on standardized numerical identifiers (SNIs). Let’s examine this a bit further.

FDA National Drug Codes will play a significant role when the DSCSA goes into full effect on Nov. 27, 2023. At that time, drug package labels must include a product identifier. A product identifier is a standardized graphic that contains the product’s SNI, a lot number, and an expiration date. The SNI comprises two data points: the National Drug Code and a unique alphanumeric serial number.

With this in mind, GS1 commented that the “SNI Guidance will need modification in advance of and as preparation for Option D implementation. The SNI guidance defined SNI as NDC + serial number. However … this does not support unique identification at every level of the packaging hierarchy, and therefore is not sufficient to support traceability. GS1 members had been able to overcome this challenge by embedding the NDC in a GTIN. However, with Option D, members will no longer have this technical mechanism.”

Final thoughts

That’s a lot to think about. The comment period for the FDA National Drug Code proposed rule ends Nov. 22, 2022, and industry stakeholders are sure to once again share their opinions in the docket. Some of the issues that could be raised include the following:

      • Companies’ serialization systems and ancillary systems could be affected because they contain and use FDA National Drug Codes.
      • Systems will have to accept and store both the current and new formats.
      • Stakeholders will have to know which format to send and when.
      • Systems may have to carry both formats simultaneously for current medicines.

The biggest takeaway, though, is that companies should be thinking about the change and preparing now. This is a DSCSA mantra, right? Prepare for the Verification Router Service (VRS). Prepare for ATPs. Prepare for  product identification, serialization, and EPCIS.

If you have questions, contact us today to speak to one of our  DSCSA and supply chain experts. We’re participating on the GS1 New NDC Format Workgroup and have been actively involved in discussions about how the changes will affect pharma companies. With only a little more than a year to go before rollout of the DCSCA is complete, now is the time to connect with us and make sure you’re going to be ready for the full serialization of the U.S. pharma supply chain.

 

Understanding GS1 Barcodes in the Global Supply Chain

Where would we be without standards? One thing’s certain: Your supply chain would be a lot messier, if not chaotic, if you and your partners didn’t have a “common language” to process and exchange data. Standardized GS1 barcodes are one way we avoid this chaos.

GS1 barcodes keep everybody “on the same page.” They allow companies in virtually every industry to easily record, store, and transfer data. We’ve all seen them, and chances are your organization uses them — maybe even millions or billions of them. But let’s do a quick refresher course as another way to keep us all on the same page.

Why are GS1 barcodes important?

The short answer is, as we said above, standardized GS1 barcodes allow us to maintain order and avoid chaos. Work flows become quicker and more efficient. The GS1 barcodes keep supply chains running by enabling companies to sell, ship, track, reorder, and return products, in most cases by scanning with a handheld device or a camera-based system.

GS1 barcodes also expedite communication, traceability, visibility, and transparency. It’s really all about sharing information quickly in order to know the source of ingredients/components and products, where they’ve been and where they’re going, and when they reach their final destination.

These capabilities not only make supply chains more efficient — they also increase product safety and protect consumers. If there’s a recall, for example, a company can locate its products quickly, make sure shipments are stopped, remove items from stores, and share data with regulators and even consumers.

GS1 barcodes also save money. Administrative costs come down when everybody uses the same standards and has the same expectations. And because GS1 barcodes facilitate digital supply chains, they increase speed and reduce paperwork.

GSI Identification Keys

GS1 standards define a set of unique identification codes, known as identification keys. GS1 says its identification keys “refer unambiguously to a real-world entity,” such as a product, a logistics unit, a physical location, a document, a service relationship, or another entity.

In other words, the ID keys let you quickly and conveniently access information about items in your supply chain and share it with your partners. Only GS1 members can build ID keys, which must include a GS1 company prefix. There are 12 ID keys:

        1. Global Trade Item Number (GTIN): identifies products and services, such as food and clothing
        2. Global Location Number (GLN): identifies parties and locations, such as companies, warehouses, factories, and stores
        3. Serial Shipping Container Code (SSCC): identifies logistics units, such as parcels and palletized products
        4. Global Returnable Asset Identifier (GRAI): identifies returnable assets
        5. Global Individual Asset Identifier (GIAI): identifies assets, such as equipment used in manufacturing and transportation
        6. Global Service Relation Number (GSRN): identifies relationships between service providers and recipients, such as hospital staff and members of brand “loyalty” or rewards programs
        7. Global Document Type Identifier (GDTI): identifies documents, such as shipping paperwork
        8. Global Identification Number for Consignment (GINC): identifies consignments, such as logistics units being transported in a container on a ship or airplane
        9. Global Shipment Identification Number (GSIN): identifies shipments
        10. Global Coupon Number (GCN): identifies coupons
        11. Component/Part Identifier (CPID): identifies components and parts
        12. Global Model Number (GMN): identifies a product’s model number

The GS1 standards also encompass data capture, including definitions of barcode and radio-frequency identification (RFID) data carriers, that allow ID keys and other data to be affixed directly to an object. Data standards also address the hardware to read and produce barcodes (e.g., scanners and printers), and hardware and software to connect the barcodes and RFID tags to business applications.

The different types of GS1 barcodes

All GS1 barcodes are “containers” that can hold different amounts information, such as serial numbers, batch numbers, GTINs, and expiration dates. As the image below from GS1 shows, there are four types, or “families,” of barcodes: EAN/UPC, two-dimensional (2D), DataBar, and one-dimensional (1D).

GS1 barcodes

EAN/UPC family. GS1 says, rightly, that these “are printed on virtually every consumer product in the world.” They are characterized by a series of vertical lines and a horizontal row of numbers, and come in four types: UPC-A, EAN-13, UPC-E, and EAN-8.

These GS1 barcodes are designed to be used at the point of sale and can be read by omnidirectional scanners. None support attributes — they cannot contain product information such as an expiration date, a batch number, or item weight. UPC-A has 12 numbers and supports GTIN-12; EAN-13 has 13 numbers and supports GTIN-13; UPC-E has 12 numbers (the zeros are “suppressed) and supports GTIN-12; and EAN-8 has 8 numbers and supports GTIN-8.

2D barcodes. Like EAN/UPC barcodes, 2D barcodes are ubiquitous. They are incredibly robust, able to hold dense product information and remain legible at greatly reduced sizes or when they’re etched into a surface, such as a plastic bottle cap. There are two kinds of 2D barcodes:

      1. GS1 DataMatrix codes are omnidirectional and support attributes and all GS1 ID keys. They can hold 3,116 numeric or 2,335 alphanumeric characters.
      2. GS1 QR codes are also omnidirectional and support attributes and all GS1 ID keys. They can hold 7,089 numbers or 4,296 alphanumeric characters.

DataBar family. There are seven members in the DataBar family. Generally, they’re divided into two groups: those designed for use at the point of sale (i.e., can be read by omnidirectional scanners) and those that are not.

The first group has four types: omnidirectional, stacked omnidirectional, expanded, and expanded stacked.

      • Omnidirectional and stacked omnidirectional have 14 numbers. They support GTINs and Global Coupon Numbers (GCNs) but do not support attributes.
      • Expanded and expanded stacked have a maximum capacity of 74 numeric and 41 alphabetic characters. They support GTINs and GCNs, but do support attributes.

There are three types of barcodes in the second group: truncated, limited, and stacked. These have 14 numbers and support GTINs, but do not support attributes. They are not designed for use at the point of sale, so they cannot be read by omnidirectional scanners.

1D barcodes. The two types of 1D barcodes — GS1-128 and ITF-14 — are used in retail distribution, healthcare, and logistics. GS1-128 barcodes can carry any GS1 ID key and up to 48 alphanumeric characters, including serial numbers, expiration dates, and other information that helps track products through a supply chain. More than one GS1-128 barcode can be used on a single item. ITF-14 barcodes can hold only GTINs; GS1 says it is suitable for printing on corrugated materials.

Final thoughts

This year was the 50th anniversary of the GTIN. As GS1 said, “It is no exaggeration to say that the development of the GTIN set the stage for global, digitalized commerce.” Indeed, labeling standards and barcode technologies have evolved and advanced since 1971 to the great benefit of businesses and consumers alike.

We have been talking about the advantages of end-to-end traceability in a digital supply chain for a long time. When your products, labeled with powerful identifiers such as 2D DataMatrix codes, move through a digital supply chain powered by our award-winning Traceability System, you can leverage rich, unit-level data for much more than compliance and operational efficiency: You can create genuine, tangible business value. For example:

That’s really just the beginning of what a digital supply chain can do. To learn more, contact us today to see a short demo of our solutions. Our supply chain experts will show you how our Traceability System transforms your supply into your most valuable strategic asset.