A new guidance published by the US Food and Drug Administration (FDA) establishes a specification by which all drug establishments will be identified under a recently established tracking system.
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 now 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." (FDASIA 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." (FDASIA Section 702)
The tracking itself will take place using an FDA-established system known as the Unique Facility Identification (UFI) system, which will allow drug manufacturing facilities and owners to register with the agency. Under FDASIA, FDA is charged with establishing the standards by which companies and individuals will register with FDA's UFI system.
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.
FDA Explains UFI Specifics
Now, more than a year after FDA first proposed a registration standard for the UFI system, the agency has finally confirmed what it proposed last year: Its UFI system will be based on Dun and Bradstreet's Data Universal Numbering System (DUNS).
"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 5 November 2014 guidance, Specification of the Unique Facility Identifier (UFI) System for Drug Establishment Registration.
"Currently, the FDA finds the DUNS number appropriate to meet Agency needs for a data standard for drug establishment registration UFI," it said.
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 guidance notably does not apply to two types of establishments mentioned in FDASIA: Manufacturers of medical devices and pharmaceutical excipients. Both topics will presumably be addressed in future guidance documents.
Specification of the Unique Facility Identifier (UFI) System for Drug Establishment Registration (FR)