Author

Registrar Corp

World's Leading FDA Compliance Experts

FDA Specifies DUNS Number as Unique Identifier for Drug Establishments

Nov 6, 2014

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.

A DUNS (Data Universal Numbering System) number is a unique nine-digit identifier for businesses, created by Dun & Bradstreet. It is widely used for establishing a business’s credit and financial records, and is recognized globally as a standard business identifier. In the context of FDA regulations, DUNS numbers are used for the registration of drug establishments, ensuring compliance with regulatory requirements. These numbers are essential for maintaining consistent and accurate records across various industries, aiding in the verification and tracking of business entities.

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 https://www.registrarcorp.com/livehelp.

Author


Registrar Corp

World's Leading FDA Compliance Experts

Registrar Corp thrives on the collective expertise of over 200 professionals, including former FDA officials and experienced industry specialists. Our team of regulatory specialists is our greatest asset, offering deep insights into the latest and longstanding FDA regulations. With our simple, straightforward, and actionable articles, you can navigate the complex regulatory landscape with ease.

Related Article


Subscribe To Our News Feed

To top
This site is registered on wpml.org as a development site. Switch to a production site key to remove this banner.