Center for Food Safety and Applied Nutrition Center for Veterinary Medicine
Office of Regulatory Affairs November 2016
On October 10, 2003, the Food and Drug Administration (FDA or we) issued an interim final
rule to implement amendments to the Federal Food, Drug, and Cosmetic Act (FD&C Act) made
by the Public Health Security and Bioterrorism Preparedness and Response Act of 2002
(Bioterrorism Act) (Pub. L. 107-188) (68 FR 58894). Section 415 of the FD&C Act (21 U.S.C.
350d) requires domestic and foreign facilities that manufacture, process, pack, or hold food for
human or animal consumption in the United States to register with FDA. This guidance was
developed to answer frequently asked questions relating to the registration requirements of
section 415 of the FD&C Act/
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