In November 2014, the U.S. Food and Drug Administration published “Specification of the Unique Facility Identifier (UFI) System for Drug Establishment Registration.” The Food and Drug Administration Safety and Innovation Act (FDASIA), signed into law in July 2012, directed the Secretary of Health and Human Services (who then delegated FDA) to specify a UFI system for registration of domestic and foreign drug establishments.
In the guidance, FDA specified the Data Universal Numbering System (DUNS) as its preferred UFI system for drug establishments. According to the guidance, “FDA has been using the DUNS number as a registration number for drug establishments since the implementation of electronic drug registration and listing” and feels that DUNS numbers will act as sufficient UFIs. Section 510 of the Food, Drug, and Cosmetic (FD&C) Act mandated that, once the UFI was specified, drug establishments would be required to include a UFI in their initial and annual registrations. Since FDA has already been requiring drug establishment registrations to include DUNS numbers since 2009, registrations will remain unchanged. DUNS numbers are assigned free of charge to all drug establishments.
Registrar Corp can help drug establishments obtain a DUNS number, as well as submit their electronic registrations for them. If you have any questions about DUNS requirements or any other FDA regulations for drug establishments, contact Registrar Corp at +1-757-224-0177 or speak with a Regulatory Specialist 24 hours a day at http://www.registrarcorp.com/livehelp.