FDA decides on format for facility registrations
pharmafile | November 11, 2014 | News story | Manufacturing and Production | FDA, fdasia, gln, gs1, manufacturing, ufi
The US FDA has finalised the details of its registration scheme for pharma manufacturing facilities, which aims to make it easier for the agency to monitor the supply chain.
The regulator is asking drugmakers to use the data universal numbering system (DUNS) to register their manufacturing facilities, both domestic plants and those based overseas that import drugs into the US.
The use of a unique facility identifier (UFI) was mandated in the 2012 Food and Drug Administration Safety and Innovation Act (FDASIA), a broad sweep of new legislation that is designed to improve the FDA’s ability to collect and analyse data to enable risk‐informed decision‐making – and address safety concerns caused by incomplete inspection coverage.
The latest document is largely similar to an earlier draft of the guidance – issued for comment just over a year ago – suggesting that while the free-of-charge DUNS code is the preferred option, pharma companies that want to use another identifier system for their facilities may be able to do so and should contact the FDA.
One paid-for alternative could be the Global Location Number (GLN) developed by barcode standards company GS1, for example, which is sometimes deployed at companies who have introduced serial numbers for medicines across multiple packaging lines.
Once the UFI is established, FDASIA requires each initial and annual drug facility registration to include the identifier, the FDA says. It added that it has been using DUNS, a system developed by data company Dun and Bradstreet, to register and track drug establishments since electronic drug registration started.
“Currently, the FDA finds the DUNS number appropriate to meet agency needs for a data standard for drug establishment registration UFI,” says the FDA. The guidance does not apply to facilities manufacturing medical devices or excipients, but active pharmaceutical ingredient (API) plants are within its scope.
Other measures introduced under FDASIA included risk-based inspections, sharing of information with other regulators, a registration fee for manufacturing sites used to make the APIs for generic drugs, a one-time fee for an assessment of the API’s drug master file (DMF) and penalties for delaying, limiting or refusing a drug inspection.
Phil Taylor
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