FDA blows off GS1 Healthcare for facility identification schema

On Nov. 5, FDA’s Office of Compliance released a guidance document, “Specification of the Unique Facility Identifier (UFI System For Drug Establishment Registration,” that essentially reiterates prior proposed guidance released a year ago. Both actions are a response to the FDA Safety and Innovation Act (FDASIA) of 2012. The two-page document simply notifies industry that the Dun & Bradstreet Data Universal Numbering System (DUNS) is to be used to identify drug establishments in documentation intended for FDA. FDA has been using this already for submission of drug registration and listing processes, and notes that the service is free.

What’s left unsaid in the document is how establishment location data necessary for tracking drug shipments (as opposed to filing paperwork with FDA) will be reconciled with DUNS. GS1’s interlocking numbering systems—GTIN for product identification, GLN for physical locations, and the EPCIS system for communicating transaction information (among others)—is looked on as the likely choice for structuring drug traceability under the Drug Supply Chain Security Act (DSCSA); additionally, many of the leading group purchasing organizations (GPOs) have been pushing suppliers (including pharma companies) to use GS1’s GLN and GTIN format for recording shipments to member organizations. GLN has the advantage over DUNS (which originated as a way to track the financial records of companies) of providing a high degree of precision on location—the specific loading dock at a hospital pharmacy, for example. It’s an open question, too, as to how readily non-US organizations will adapt to the DUNS system.

GS1 issued a position paper a couple years ago highlighting its claimed advantages over DUNS. But in FDA’s defense, it is a matter of policy not to require use of nongovernmental resources that have a cost associated with them (companies must pay for obtaining GS1 numbers, if only a nominal fee). But the counter to that is that a great number of healthcare suppliers have already obtained GS1 identifications, making it something of a de facto standard.

The incompatibility between GLN and DUNS is not on a par with, say, Apple IOS and Android. IT managers and database administrators are likely to work out how to encompass one number in the other, or provide data fields in records for both identification formats. But it demonstrates yet another hurdle to overcome in getting universal, interoperable traceability data into the mainstream.