Data Universal Number Systems, commonly known as DUNS are unique, site specific, nine-digit identification numbers provided by Dun & Bradstreet (D&B) and used globally. Free to obtain, FDA and other federal agencies use DUNS numbers to track and verify company name, address, phone number, URL, etc.
FDA uses DUNS numbers for a variety of facility registrations and product listings as a way of verifying the applicant is in fact a legitimate business and that the business contact information has been verified. Examples of FDA DUNS number requirements are importers of pharmaceutical products into the US. DUNS numbers are also required for foreign entities to pay FDA user fees such as GDUFA.
Additionally, food importers under FSVP are allowed, as of a March 2017 guidance document to use a DUNS number as the company’s Unique Facility Identifier (UFI).
For companies already using the DUNS system, it is critical to ensure the D&B database has accurate and current information. DUNS errors are the most common failure of drug establishment registration and listing validations. Currently drug establishment registrations require a DUNS number. As of October 2020, all food facility registrations will also require a DUNS number.;
How do you know if your company has a DUNS number? You can check your company’s number on the FDA DUNS Portal, (if you don’t already have an account to use this portal, you’ll have to create one). You can also use this portal to obtain a new DUNS number, by using these step by step instructions. Of course, should you wish EAS regulatory experts to assist your company with obtaining or verifying a DUNS, we are glad to do so. As a reminder, if you are a foreign firm doing business in the US, having a DUNS number can streamline registrations, and in some cases, is required.
For more information, contact Victoria Pankovich, EAS regulatory specialist.