Last week the FDA published draft, non-binding guidance for their recommended unique facility identifier (UFI) for use in registering foreign and domestic drug establishments. Last year, Congress passed the FDA Safety and Innovation Act (FDASIA) to address safety concerns induced by inspection gaps of facilities outside the United States and other issues (see “The Supply Chain Provisions Of The FDA Safety & Innovation Act”). In that law, Congress required the FDA to come up with some way of uniquely identifying all foreign and domestic facilities that are involved in the manufacture and importation of drugs. This new guidance is the response.
The new draft guidance is very short. It simply identifies their choice of Dun and Bradstreet’s Data Universal Numbering System (DUNS)—a unique nine-digit number—for the FDA UFI. The draft points out that the “FDA has been using the DUNS number as a registration number for drug establishments since the implementation of electronic drug registration and listing…”, so apparently this is just a continuation of its use.
According to the guidance, DUNS numbers are “…free of charge to all drug establishments…”. But remember, this guidance is not binding. If you would rather use some other identifier for your registrations, the FDA allows for that…”If you want to use an alternative identifier for your drug establishment, contact FDA via email at eDRLS@fda.hhs.gov”. I mean, after all, if you have paid for a GS1 Company Prefix (GCP), you are probably going to want to use it wherever you are allowed to. In that case, you would use GS1’s Global Location Number (GLN) instead of the DUNS number, but check with the FDA first.
In some ways, it seems like a departure from the direction the FDA appeared to be taking after the Standardized Numeric Identifier (SNI) guidance where they aligned behind three different standards for drug serialization, including GS1, HIBCC and ICCBBA. When Congress called for that standard to be developed, they explicitly instructed the FDA that the SNI standard “…be harmonized…with internationally recognized standards for such an identifier” (see “FDA Aligns with GS1 SGTIN For SNDC”). Selecting standards from GS1, HIBCC and ICCBBA fulfilled those instructions.
DUNS is also an “internationally recognized standard for such an identifier”, but all of these standards work best if you can use them as a family (see “GS1 Standards – Betcha Can’t Use Just One!”), so, on the one hand, it seems like it might have made more sense to pick GS1, HIBCC and ICCBBA standards for location identification just as they did with the SNI so that companies could choose to stay within their chosen family of standards. On the other hand, the fact that they seem to allow you to choose your own location identification standard perhaps makes this less of an issue and therefore less surprising.
According to the D&B website, DUNS has been around since 1962 and was “adopted” by the U.S. Government for location and entity identification in 1997. It is used to identify companies wishing to get a government contract, grant or loan.
“…the D-U-N-S® Number is recognized, recommended, and/or required by more than 200 global, industry, and trade associations, including the U.N., European Commission, and the U.S. Federal Government.”
Registration of a drug manufacturer’s facilities using a DUNS number for FDASIA purposes today is innocuous, but down the road, manufacturers will likely also need location identifiers for many of those same facilities for ePedigree and track & trace purposes. The FDA was instructed by Congress to identify standards for track & trace in the FDA Amendments Act (FDAAA) of 2007 but they have not yet done so because there was no time limit specified (see “InBrief: FDA To Publish Track & Trace Standard By Year End” from 2012 and “InBrief: FDA Again Says It Plans To Publish Track & Trace Guidance By Year End” from earlier this year).
It will be very interesting to see if the FDA selects an existing standard for track & trace—like GS1’s Electronic Product Code Information Services (EPCIS)—or if they simply identify necessary characteristics that might allow companies to choose EPCIS or other standards from other standards organizations. The only problem with that latter approach is that you would then end up with some serious interoperability problems.
If the FDA eventually chooses GS1’s EPCIS for track & trace, then using GS1’s GLN for location identification of manufacturing facilities could turn out to be a better choice (if the FDA allows it) than DUNS. But now that the FDA officially prefers DUNS for location identification, GS1 should add the ability to use DUNS numbers in EPCIS track & trace events in place of GLNs. That’s not likely to occur (except perhaps in GS1 US, the GS1 Member Organization (MO) in the United States).
It will all become a lot more clear when the FDA eventually publishes their track & trace guidance, hopefully by the end of this year, unless it is held up by a new federal pedigree bill that we are also watching for (see “The Federal Lot-Based Pedigree Before Congress” and “The Politics Of Federal Track & Trace Legislation”. Until then, the uncertainty continues (see “California ePedigree Uncertainty”).