FDA Publishes Enforcement Policy Guidance for Providing Acceptable Facility Registration UFI
On December 1, the FDA published an updated guidance that explains how to comply with FDA’s requirement to provide a Unique Facility Identifier (UFI) recognized as acceptable by FDA when submitting a food facility registration or renewal. The guidance also provides information on what to do if a facility is unable to timely obtain a Dun & Bradstreet (D&B) Data Universal Numbering System (DUNS) number prior to the end of the biennial renewal period on December 31, 2020.
As a reminder, beginning October 1, 2020, a facility’s UFI must be submitted with the registration information. 21 CFR 1.232(a)(2). The UFI will be used to verify that the facility-specific address associated with the UFI is the same address associated with the facility’s registration. To date, the FDA recognizes the DUNS number as an acceptable UFI.
According to the guidance, in order to address stakeholder concerns, FDA intends to allow registrants who anticipate that they will be temporarily unable to provide a DUNS number with their registration or renewal to enter “PENDING” in the UFI field of their registration. This temporary entry will allow for registrations and renewals to be submitted even if the registrant has not yet provided a DUNS number. Upon submission, the registrant will have 90 calendar days to update their registration with their DUNS number. Failure to update the registration with a valid DUNS number within 90 calendar days will result in cancellation of the registration.
As our readers know, domestic and foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States are required to register with FDA. Registered facilities are required to renew the registrations by December 31, every even-numbered year commencing with 2012.