US FDA has issued the latest guidance on the specification of the Unique Facility Identifier (UFI) System for Drug Establishment Registration . The 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.
The objective of the directive dated November 2014 is to ensure registration of the pharmaceutical production facility across the world. This will provide transparency of the operations and status of each production plant.
According to Kaushik Desai, pharma consultant, Hon General Secretary, Indian Pharmaceutical Association and Chairperson, Industrial Pharmacy Section, Federation of Asian Pharmaceutical Associations (FAPA), this is a step in the right direction and positive one because it enables streamlining and identifying manufacturing facilities globally.
The regulator stated that this guidance specifies the unique facility identifier 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.
In July 2012, FDASIA was signed into law. Sections 701 and 702 of FDASIA directed the Secretary of Health and Human Services (Secretary) to specify the UFI system for registration of domestic and foreign drug establishments. 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 (21 U.S.C. 360(b), (c), and (i)).
The guidance, according to US FDA is intended solely to address sections 701 and 702 of FDASIA to specify the UFI system for registration of domestic and foreign drug establishments. The guidance reflects current thinking in light of data standards, information technology, and information management resources. As these variables change over time, FDA may revisit this guidance and the specification made in section III of this guidance.
For drug establishment registration, FDA is specifying a 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 for information on the electronic submission of registration and listing data.
Currently, FDA finds the DUNS number appropriate to meet Agency needs for a data standard for drug establishment registration UFI. The DUNS number is available free of charge to all drug establishments, and further information is available on the FDA web site aid the regulatory authority.