Pharmaceutical companies are now required to embed a standardized product identifier, serial number, lot number, and expiration date in a 2D barcode, on all individual drug packages.

The pressure is on for companies to comply with the FDA’s Drug Supply Chain Security Act (DSCSA) lowest saleable unit and homogeneous case serialization requirements with the November 27, 2017 deadline now passed.  

A barcode assessment conducted last May at two of largest wholesalers’ distribution centers showed that a meager single-digit percentage of packages that were scanned carried the necessary data—raising concerns that the industry was far from ready for compliance in November. This past summer, the FDA announced an enforcement delay giving companies an additional year to become compliant before any penalties will be levied.

The one-year reprieve gives pharmaceutical manufacturers the opportunity to implement proper sterilization solutions, with concerted effort to meet the requirements before November 27, 2018.

There is no time to lose since the transition to unit-level serialization is not a quick fix. Forward action must begin in earnest, if it hasn’t already. The mandatory product identifier can be a GS1 Global Trade Item Number (GTIN) or an FDA National Drug Code (NDC).

Working together as members of the GS1 Healthcare US Initiative, the voluntary industry group implementing global standards to address patient safety and deliver supply-chain efficiencies, industry stakeholders have learned that common questions and ambiguities have contributed to the companies’ delays in implementing DSCSA serialization requirements.

Answering some of these questions, they offer some clarity and guidelines to help.

Difference Between GTINs and NDCs

The NDC is a 10-digit number used to identify pharmaceutical products that are subject to U.S. FDA regulation.

A GTIN is an 8-, 12-, 13-, or 14-digit number used to identify all types of trade items, including pharmaceutical products, medical devices, consumer products outside of the healthcare sector, and non-consumer trade items across all sectors.

Commercial pharmaceutical products sold in the United States with an embedded NDC will be in a GTIN-12 in a 14-digit format.

The GTIN uniquely identifies not only the lowest saleable unit, but also the homogeneous case. So, for example, a 30-tablet bottle of Drug XYZ will have one GTIN, and a 12-bottle case of the same drug will have a different GTIN.  

Often, both are used, with an NDC embedded inside the GTIN.

FDA NDC Numbers, and GS1 Company Prefixes

When the FDA NDC number is embedded in a GTIN for use in GS1 barcodes and data sharing standards, the NDC number becomes part of the GS1 Company Prefix portion of the GTIN.

Specifically, the GS1 Company Prefix consists of the digits “03” followed by 4-5 digits of the NDC, resulting in a 6- or 7-digit GS1 Company Prefix.

Just as the NDC is assigned to a drug manufacturer for its exclusive use in creating NDCs, the GS1 Company Prefix consisting of “03” followed by the labeler code is assigned by GS1 US to the same manufacturer for its exclusive use in creating GTINs that embed those NDCs.

This means that if you are a drug manufacturer and you need to create GTINs that embed your NDCs, you must obtain a GS1 Company Prefix corresponding to your FDA labeler code (or for each FDA labeler code if you have more than one).

You will obtain a GS1 Company Prefix consisting of “03” followed by the digits of your labeler code.

Using Multiple GS1 Company Prefixes and NDCs

You can use any of your GS1 Company Prefixes to generate any GS1 identification number.

However, if you are a manufacturer or re-packager that creates GTINs for drugs identified by a U.S. FDA National Drug Code, you must use the specific GS1 Company Prefix that embeds your NDC.

For each NDC labeler code that you use, you must register for a GS1 Company Prefix that embeds that labeler code, so that you can create GTINs that embed NDCs using that specific labeler code.

Linear Barcodes Are No Longer Enough

DSCSA requires pharmaceutical products to be marked with a barcode that carries its NDC (typically embedded within a GTIN), serial number, lot number, and expiration date. Prior FDA regulations required individual sale units to be marked with a linear barcode containing the NDC. 

To satisfy both of these requirements, many pharmaceutical manufacturers are marking products that move through a point-of-sale (POS) with both a UPC-A (to satisfy the FDA linear barcode requirement) and a GS1 DataMatrix (to satisfy DSCSA serialization/traceability requirements). Higher-level groupings that do not cross point-of-sale, such as homogeneous cases, are marked with just the GS1 DataMatrix.

 

EPCIS Facilitates Interoperable Information Sharing

DSCSA requires manufacturers, distributors, re-packers, and dispensers to capture and share information, using standards for interoperable exchange of information, about transactions in the supply chain in which ownership of pharmaceutical products is transferred.

GS1 Electronics Product Code Information Services (EPCIS) is an open standard that allows businesses to capture and share supply chain information about the movement and status of goods, both within their enterprise and with their business partners.

EPCIS provides a standard language, expressing this information in an interoperable manner. The DSCSA law does not specifically require the use of EPCIS, but GS1 US and its member companies have worked to create a method for applying EPCIS to meet the requirements of DSCSA, and many companies will adopt EPCIS as the preferred method for doing so.

EPCIS Supports Supply Chain Data Exchange

EPCIS is designed to support full track-and-trace of products for many different purposes.

By using EPCIS to meet the requirements of DSCSA, you lay the foundation not only for DSCSA compliance, but also for using supply chain data for a myriad of purposes—including tracking and tracing recalled product, new product introduction, anti-counterfeiting, product authentication at point of use, optimization of supply chain routes, and more.

EPCIS lays the foundation for knowing where your products are at any time, any place in the supply chain, and the possible uses of this data for business benefit are limitless. In this respect, EPCIS is far superior to siloed approaches such as devising a single-purpose data model exclusively for DSCSA compliance.

The EPCIS approach allows all companies to maximize the return on the investment made in gathering the data in the first place. Many of the leading companies in the U.S. pharmaceutical market have stated their desire to standardize on EPCIS and the GS1 US Implementation Guideline: Applying GS1 Standards for DSCSA and Traceability, Release 1.2 as the preferred means to meet DSCSA data requirements. Using EPCIS helps assure that you are using a best practice for DSCSA data reporting and you will have the greatest degree of interoperability with other trading partners.

Barcode Scan Records One Data Point to EPCIS

An EPCIS event is the record of a particular step of a business process. So, in addition to the identifiers scanned from the barcode (i.e., the what dimension of an EPCIS event), the EPCIS event also includes the date and time (the when dimension), location identifiers (the where dimension), and data that describes the business context, including the business step being carried out (the why dimension).

This means that an EPCIS event does not come directly out of a barcode scanner, but rather the barcode scan is an input to software that is implementing a particular step of a business process, such as packing, shipping, receiving, etc.

It is the job of this software to assemble all of the information needed to construct the event, including the data coming out of the barcode scanner, and deliver it as a finished EPCIS event.

Time and Resources

Generating the proper identifiers for DSCSA compliance is a process; companies that have already achieved compliance are advising others to pay close attention to data quality and entry, to test their systems before deployment, and to share best practices.

It is not an exercise to be rushed, and with the enforcement deadline now less than one year away, companies that have not started need to get top-down alignment and an aggressive, quality-driven program under way so that when the time comes, they’ll be ready.

About the Author
Peter Sturtevant is Sr. Director Industry Development–Pharmaceuticals at GS1 US, a not-for-profit information standards organization with more than 300,000 members. GS1 Standards are the most widely used supply chain standards in the world; www.gs1us.org/DSCSA

This story can also be found in the March 2018 issue of  Pharmaceutical Processing.

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