FDA Issues Procedural Guidance for Drug Establishments

From DCAT Value Chain Insights (VCI)

By Regulatory News posted 11-11-2014 13:29


The US Food and Drug Administration (FDA) has issued final guidance, Specification of the Unique Facility Identifier (UFI) System for Drug Establishment Registration. This guidance specifies the UFI system for registration of domestic and foreign drug establishments. It is intended to address provisions set forth in section 510 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360), as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA) (Public Law 112-144), regarding the specification of the UFI system.

Once the UFI system is specified, section 510 of the FD&C Act, as amended, requires that each initial and annual drug establishment registration include a UFI. For drug establishment registration, the FDA has specified that its preferred UFI for a drug establishment is the Data Universal Numbering System D-U-N-S (DUNS) number, assigned and managed by Dun and Bradstreet. FDA has been using the DUNS number as a registration number for drug establishments since the implementation of electronic drug registration and listing and said it finds the DUNS number appropriate to meet the agency's needs for a data standard for drug establishment registration UFI.

Source: FDA


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