A new cross-center draft guidance document released by the US Food and Drug Administration (FDA) established the agency's preferred unique facility identification (UFI) system used to register facilities for the purposes of collecting user fees and conducting inspections.
Under the Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012, both domestic and foreign facilities whose products are imported into the US are required to register with FDA.
Specifically: ''During the period beginning on October 1 and ending on December 31 of each year, every person who owns or operates any establishment in any State engaged in the manufacture, preparation, propagation, compounding, or processing of a drug or drugs shall register with the Secretary the name of such person, places of business of such person, all such establishments, the unique facility identifier of each such establishment, and a point of contact e-mail address." (Section 701)
This requirement also applies to "Every person who owns or operates any establishment within any foreign country engaged in the manufacture, preparation, propagation, compounding, or processing of a drug or device that is imported or offered for import into the United States." (Section 702)
In addition, the legislation calls for FDA to "specify the UFI system that shall be used by registrants," most notably all drug manufacturers. While Section 701 also calls for domestic medical devices to undergo a similar registration process, that process is not established in the draft guidance, Specification of the UFI System for Drug Establishment Registration.
The overall intent of the two FDASIA sections is evident by the title of the law in which they are contained: "Drug Supply Chain." Due to a rash of incidents with the integrity of the supply chain around the time FDASIA was passed into law, legislators intended to introduce several provisions to strengthen the security of the pharmaceutical supply chain. Being able to more quickly trace back a product to its original manufacturer, and even the manufacturer of an active pharmaceutical ingredient, would allow regulators to more effectively monitor the supply chain and conduct recalls as needed.
And the Winner is…
The UFI system called for in FDASIA has now been selected, and it is-unsurprisingly, for those familiar with FDA's traditional registration processes-the Data Universal Numbering System (DUNS) system, which is maintained by the company Dun and Bradstreet.
"The FDA has been using the DUNS number as a registration number for drug establishments since the implementation of electronic drug registration and listing," FDA explained in its draft guidance. "Currently, the FDA finds the DUNS number appropriate to meet Agency needs for a data standard for drug establishment registration UFI."
FDA noted that the DUNS number is available free of charge to all drug establishments, but that alternative identifiers may be acceptable for use for drug establishments. Firms interested in using the alternative should contact FDA's electronic drug registration and listing office at eDRLS@fda.hhs.gov.
The Federal Register posting on the draft guidance is likely to be published on 6 September 2013, at which time a 60- to 90-day comment period is expected.
Specification of the UFI System for Drug Establishment Registration