2012 GTIN Sunrise and GTIN Allocation Rules for Healthcare

The Global Trade Item Number is the fundamental product identification key in the GS1 System. Uniqueness at every level of packaging is essential…and soon.

We hear a lot these days about sunrise dates in the global GS1 System of product identification and related supply-chain standards. A sunrise date is a date in the future, agreed to and typically announced years in advance, at which point an industry or market sector is expected to be prepared to implement a specific technology.

It started with “Sunrise 2005,” the GS1 US initiative to have North American retailers update their point-of-sale (POS) systems to accept EAN-13 data structures in addition to the familiar UPC-12. Trading partners were also reminded that UPC-12 and EAN-13 are, essentially, shortened representations of what is fundamentally a 14-digit data structure. For this reason it was recommended that all supply-chain data processing systems (including POS) be updated to handle the Global Trade Item Number (GTIN)-14 identifier, not just 12 or 13 digits.

Sunrise 2005 was followed by various GS1 US sunrise dates pertaining to the adoption of specific GS1 DataBar symbology formats at retail, specifically on loose fruit and produce and as a complementary symbol in addition to the UPC on manufacturer coupons (both by January 1, 2010). In addition, retailers are expected to be able to accept specific versions of GS1 DataBar on general merchandise items as of January 1, 2014.

“2010 GLN Sunrise” is the healthcare industry-accepted sunrise date for adoption and use of the GS1 Global Location Number (GLN) as the single, unique identifier for “Order-by/Sold-to, Ship-to, Bill-to, and Paid-by” entities/locations throughout the supply chain. It is intended to replace a variety of different entity/location schemes (e.g., D&B Duns, HIBCC HIN, and custom account/location). Although we are now beyond the 2010 GLN Sunrise date of December 31, 2010, not all trading partners in the supply chain have yet adopted or fully implemented the initiative.

As with GLN, there is a GTIN sunrise date (“2012 GTIN Sunrise” is December 31, 2012) by which time manufacturers/brand owners in the healthcare supply chain are to have identified their products at all levels of packaging using GTINs and should be printing GTIN bar codes on all appropriate packaging levels. According to John J. Roberts, JD, Director, Healthcare, for GS1 US (Lawrenceville, NJ), “The GLN and the GTIN sunrise initiatives are driven by the critical need to improve the efficiency of business process transactions and to increase patient safety. They are supported by group purchasing organizations (GPOs), healthcare manufacturers and distributors, and hospitals/providers. GS1 US serves as the facilitator in bringing these constituencies together to develop and implement a unified approach to achieve these common goals.”

The GTIN is used for the unique identification of trade items worldwide. GS1 defines a trade item as “any item (product or service) upon which there is a need to retrieve predefined information and that may be priced, or ordered, or invoiced at any point in any supply chain. This includes individual items as well as all their different configurations in different types of packaging.”

It is expected that by the end of 2012 the following goals will be achieved:

• GTINs will be assigned to all healthcare products.
• GTINs will be communicated in business transactions.
• GTINs will be bar coded on appropriate packaging levels.
• GTINs will be scanned at points-of-delivery and care.
• GTINs will be used in product returns and recalls.
• GTINs will be registered in a GS1 Global Data Synchronization Network (GDSN)-certified Data Pool.

What does this mean to pharmaceutical and medical products manufacturers and their supply chain partners?
Pharmaceutical manufacturers adopted the GTIN-12 product identification scheme for over the counter (OTC) products in the 1970s (it was known then simply as the Universal Product Code or UPC) because UPC codes were required for retail packages by grocery and chain drug stores. It was at that same time that FDA introduced the National Drug Code (NDC) and, with impressive foresight, FDA and GS1 US collaborated to make it possible to embed the 10-digit NDC into the 12-digit UPC.

This coding scheme was widely embraced. In the decades that followed, the U.S. pharmaceutical supply chain, covering both OTC and prescription drugs, broadly adopted GS1 product identification standards for drug packages at and above the pharmacy unit of sale. Today, in addition to using GTIN-12 (the new name for UPC-12) on all retail packages, virtually every U.S. drug manufacturer identifies homogenous case packs (full cases of the same GTIN with the same lot number and expiration date) using the expanded GTIN-14 data structure. GTIN-14 identifiers are derived from the GTIN-12 codes for the individual units of sale contained within the case pack.

This same NDC-based GTIN-14 can also be used at the unit-of-use packaging level in order to comply with the 2004 FDA bar code rule (as can GTIN-12) and the vast majority of U.S. pharmaceutical manufacturers use the GS1 GTIN-14 to identify drugs at the unit-dose/unit-of use level.

The FDA bar code rule also permits coding schemes and bar code symbologies defined by the Health Industry Business Communications Council (HIBCC) Health Industry Bar Code (HIBC) Supplier Labeling Standard. A few drug manufacturers still embrace certain options (previously) permitted under this standard. However, effective with the 2009 revision of the standard (ANSI/HIBC 2.3), HIBCC unilaterally eliminated the “HIBC Primary Data…Small Package” coding and marking options, without setting a “sunset” date to give users time to migrate to the GS1 System.

Migration to the GS1 System (or adopting it more fully) is, in essence, what “2012 GTIN Sunrise” is all about. At the most fundamental levels—GTINs assigned to all products, GTINs communicated in business transactions, and GTINs marked in bar code form on applicable packaging levels—the U.S. pharmaceutical industry is already substantially compliant. However, it is quite a different story for medical/surgical product and device manufacturers, many of whom either identify and bar code their products according to the HIBCC Supplier Labeling Standard, an internal proprietary standard or do not use a bar code at all.

Whether one is adopting and assigning GTINs for the first time or simply maintaining and updating GTIN assignments, it is imperative that one understand and follow the Healthcare GTIN Allocation Rules published by GS1. According to these rules:

• GTINs uniquely identify trade items in the supply chain, with a unique GTIN for every level of packaging.
• The integrity of GTINs throughout the item’s lifetime (and for four years thereafter) is essential.
• A change to one aspect or characteristic of a trade item may require the allocation of a new GTIN.
• Once assigned, GTINs are nonsignificant and should always be recorded and processed in their entirety.
• Trade items at the retail sale, shelf-pack, or stock keeping unit level typically are assigned a GTIN-12 or GTIN-13.

In the United States, the near-universal practice is to assign GTIN-14s to uniform groupings of trade items, e.g., homogenous case packs (a standard grouping of identical trade items having the same lot/batch number and/or expiration date, where applicable). It is also common in the U.S. pharmaceutical supply chain to use GTIN-14 to identify unit-dose and unit-of use packages, especially where companies want to maintain the commonality of the FDA-registered National Drug Code across all levels of packaging.

As previously noted, the rules for allocating GTINs generally require that unique GTINs be used to identify—and differentiate—the lowest level of packaging from other packaging levels, whenever 1) there is “a need to retrieve pre-defined information” about the item and 2) that item “may be priced or ordered or invoiced at any point in the supply chain.” For most items the decision as to whether to assign a GTIN to a particular packaging level is clear; but it may not always be so.

Questions can arise about whether or not the manufacturer should assign a GTIN to an item of little individual value and which is not packaged for individual sale. Adhesive bandages are an often cited example; plastic syringe needle tip caps would be another. Costing less than 10 cents each, such items are typically packaged in packs of 10, 25, 50, 100, or more pieces and the lowest unit of sale may be several of these multipacks.

However, an individual adhesive bandage or needle tip cap should, in fact, be assigned a distinct GTIN by the manufacturer (likely a GTIN-14, derived from the “base” GTIN-12 or GTIN-13 typically assigned by the manufacturer to the unit of sale), even if this item (at this packaging level) is not sold by the manufacturer or distributor. Particularly for the hospital/provider, it may be helpful to clearly enumerate an individual item, even when that item is of little value. Examples of where that could be necessary include on a bill of materials and for detailed cost accounting.

While it is possible in principle to enumerate some fractional part of a unit of sale, identifying the literal integer number of units required or consumed using its own unique GTIN is the more appropriate approach. Moreover, because it could be necessary for the hospital/provider to retrieve predefined information and/or price such an individual unit, the requirement for unique GTIN assignment is clearly met.

Astute manufacturers are cognizant of this potential use of unique GTINs by their end-user customers and are beginning to take the time to structure and publish GTIN assignments at this level, even though there may be no use for this identifier by the manufacturer or distributor, other than the sales and marketing value of being customer-centric.

The decision to assign a unique GTIN to a low-cost unit-of-use is separate from the decision to individually package and bar code such a product. The assignment and publication of a GTIN for every unit-of-use, whether salable or not, is principally a matter of database administration and marketing communications. For products that will never be individually packaged or bar coded at unit-of-use, even though they have a unique GTIN, there is no impact on package engineering or associated packaging costs.

Beyond assigning GTINs to every level of packaging from the unit-of-use and above, the 2012 GTIN Sunrise initiative anticipates that manufacturers will use the GTIN to identify trade items in routine business communications, including product introduction announcements, product catalogs, order entry and acknowledgement, advance ship notices, invoices, return merchandise authorizations, recalls, and regulatory filings. GTINs should be used whether such communications are in print form or via electronic data interchange.

The GS1 Healthcare GTIN Allocation Rules cover procedures—and provide examples to help users understand the requirements—for assigning a new GTIN when a predefined characteristic changes; when a new higher level packaging configuration is introduced; and when a product or brand is sold to another company, among other scenarios.

One example of a change to a predefined characteristic that would necessitate a new GTIN would be the change of the language on a product package, say from English to French, where both products would exist in parallel. However, on a product “where there is an addition to an existing language cluster, the GTIN will remain the same.” Another example is a declared change in net content.

GTIN allocation rules for the global healthcare supply chain provide the foundation upon which efficient business processes and improved patient safety are built. Sunrise dates establish a timeline toward which committed supply chain partners can work in a collaborative manner to achieve these common goals.

However, just because a sunrise date has come and gone, it does not mean that all trading partners have met the goals and are ready to transact business under a new paradigm. Never assume. Always check with your supply chain partners before making the decision to bring a critical new business practice online, especially when migrating from one standard to another.

George Wright IV is Chair of the AIM Technical Symbology Committee (TSC), a certified GS1 US Bar Code Consultant, and a regular contributor to Pharmaceutical & Medical Packaging News. Questions, comments, or requests for application assistance may be emailed to the author at [email protected].

Download GS1 Healthcare GTIN Allocation Rules here:

http://www.gs1us.org/sectors/healthcare/product_identification_gtin