FDA Favoring DUNS for Manufacturing Plant IDs in FDASIA
October 10th, 2013 // 12:54 pm @ jmpickett
FDA stated early this month that the DUNS system is what it prefers for the identification of drug facilities, according to new draft guidance by the agency.
This decision is coming after the signing of FDASIA, or the Food and Drug Administration Safety and Innovation Act. The new law has had a major effect on pharmaceutical companies. The introduction of FDA inspection fees for generic drug companies has gotten a good deal of attention.
FDASIA also requires that the agency have a detailed registry of drug manufacturing plants – both in the US and abroad. Each plant is given a unique facility identifier, or UFI. This allows FDA to keep close track of its cGMP inspections.
The new draft guidance that was issued states that FDA chose the Data Universal Numbering System, or DUNS, which is run by Dun and Bradstreet, a commercial information company.
FDA has used DUNS for the registration of drug companies since electronic drug registration and listing was implemented. FDA has determined that using the DUNS system is the most appropriate for FDA to meet the needs for a data standard for drug plant registration UFI.
FDA also has noted that drug companies can get a DUNS number at no cost on its site. Manufacturers can use another type of number, but they have to explain this to FDA.
FDA chose DUNS under FDASIA just months after EDQM, or the European Directorate for the Quality of Medicines, adopted the system to better the traceability of medical drug ingredients.
Since July, all companies with a certificate of suitability for the CEP, or European Pharmacopoeia, which deals with all APIs, have been mandated to use the DUNS number at the facility where the components were made.
