The US FDA says the DUNS system as its preferred means of identification for drug manufacturing facilities in new draft guidance issued this month.
The signing of the Food and Drug Administration Safety and Innovation Act (FDASIA) into US law last year had a significant impact on pharmaceutical firms, with the introduction of inspection fees for generic drugmakers attracting considerable attention.
FDASIA also ushered in the requirement that the FDA maintain a registry of manufacturing sites – both domestic and international – in which each plant is assigned a unique facility identifier (UFI) to allow the agency to keep track of inspections.
In the new draft guidance explains that it has selected the Data Universal Numbering System (DUNS), which is assigned and managed by commercial information firm Dun and Bradstreet, as its preferred UFI.
“The FDA has been using the DUNS number as a registration number for drug establishments since the implementation of electronic drug registration and listing…Currently, the FDA finds the DUNS number appropriate to meet Agency needs for a data standard for drug establishment registration UFI.”
The FDA also points out that drugmakers can obtain DUNS numbers free of charge via its website . Manufacturers are permitted to use alternatives, but they will need to explain their choice to the agency.
The US regulators selection of the DUNS numbering system follows just a few months after the European Directorate for the Quality of Medicines and Healthcare (EDQM) adopted it as part of its efforts to improve the traceability of drug ingredients.
Since July 15 all holders of certificates of suitability to the European Pharmacopoeia (CEP) – which cover drug active pharmaceutical ingredients (AP) – have been required to list the DUNS number of the facility at which they were produced.