Section 415(a)(3) of the FD&C Act requires facilities that are required to register with FDA to
renew their registrations every other year, during the period beginning on October 1 and ending
on December 31 of each even-numbered year.
FDA will consider a registration for a food facility to be expired if the registration is not renewed
as required (21 CFR 1.241(b)). FDA will consider a food facility with an expired registration to
have failed to register in accordance with section 415 (21 CFR 1.241(b)). The failure to register a
food facility in accordance with section 415 is a prohibited act under section 301(dd) of the
FD&C Act (21 U.S.C. 331(dd)).
