Questions and Answers Regarding Food Facility Registration (Seventh Edition): Guidance for Industry

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Food and Drug Administration Nov 15, 2016

This draft guidance, when finalized, will represent the current thinking of the Food and Drug Administration (FDA or we) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff responsible for this guidance listed on the title page. 

I. INTRODUCTION

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.

The FDA Food Safety Modernization Act (FSMA) (Pub. L. 111-353), enacted on January 4, 2011, amended the food facility registration requirements in section 415 of the FD&C Act.

The first edition of this document was issued as Level 2 guidance pursuant to Title 21, Code of Federal Regulations (CFR), Section 10.115 (21 CFR 10.115) and was made available on FDA's website on December 4, 2003. The second, third, fourth, and fifth editions of this document were issued as Level 1 guidance documents pursuant to 21 CFR 10.115 and were made available on FDA’s website on January 12, 2004, February 17, 2004, August 2004, and December 2012, respectively. The sixth edition was issued as Level 1 guidance and included one additional question and answer relating to a proposed change to the “farm” definition in 21 CFR 1.227 (79 FR 58524; September 29, 2014). The new question and answer was identified with the date that it was added to the guidance. The sixth edition was immediately effective because FDA had determined that prior public participation was not feasible or appropriate. 

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