US FDA is expected to issue a guidance on the specification of the Unique Facility Identifier (UFI) System for Drug Establishment Registration. The draft of this guidance has been circulated to the industry which has commented and provided their views on the move. Now the regulatory authority is reviewing the industry submissions and is in the process of making adequate efforts to issue the guidance.

The Indian pharma industry is upbeat on the guidance. This is because the  guidance would ensure total transparency in the operations of the production plant besides indicating the kind of infrastructure in place. This would ensure faster US FDA clearances and easier facility audits.

In 2013, nine companies covering two plants of Ranbaxy, two of Wockhardt,  Strides Arcolab, Hospira, Aarti Drugs, Jubilant Life Sciences’ subsidiary Jubilant HollisterStier and Glenmark came under US FDA scrutiny. The strict norms from global regulators of US and EU sees ample pressure building for the Indian pharma industry. The rising audit inspections are leading to point out infringement in manufacturing processes. In some cases despite the identified breach in production is not adequately addressed to satisfy the regulators. Now with the US FDA coming out with Unique Facility Identifier System for Drug Establishment Registration it would ensure corrective and preventive action (CAPA) within each industry at every stage of production. Moreover the industry would be on guard to ensure that no slips occur going the close monitoring by the Unique Facility Identifier System, said the industry.

Now the UFI guidance specifies the system for registration of domestic and foreign drug establishments. These rules are intended to address provisions set forth in section 510 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360), as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA) (Public 23 Law 112-144), regarding the specification of the UFI system.

In July 2012, Food and Drug Administration Safety and Innovation Act (FDASIA) was signed into law. Sections 701 and 702 of FDASIA directed the Secretary to specify the UFI system for registration of domestic and foreign drug establishments. Once the UFI system is specified, section 510 of the FD&C Act, as amended, requires that each initial and annual drug establishment registration include a UFI (21 U.S.C. 360(b), (c), and (i)), stated the regulatory authority.

Further, the guidance is intended solely to address the provisions in sections 701 and 702 of FDASIA that direct the Secretary to specify the UFI system for registration of domestic and foreign drug establishments. This guidance reflects current thinking in light of data standards, information technology, and information management resources. As these variables change over time, the FDA may revisit this guidance and the specification made in section III of this guidance.

For drug establishment registration, FDA is specifying the UFI System where the regulatory authority’s preferred UFI for a drug establishment is the Data Universal Numbering System D-U-N- S (DUNS) number, assigned and managed by Dun and Bradstreet. Now the FDA has been using the DUNS number as a registration number for drug establishments since the implementation of electronic drug registration and listing.