Food

Establishment & Maintenance of Records

FDA Actions on the Food Safety Modernization Act of 2011

In February 2012, FDA published an Interim Final Rule amending FDA’s regulation on the record availability requires in section 1.361 (21 CFR 1.361) as part of its implementation of the amendments to the Federal Food, Drug, and Cosmetic Act made by the FDA Food Safety Modernization Act.

Guidance for Industry: What You Need to Know About Establishment and Maintenance of Records  (December 2004; April 2014)

Guidance for Industry: FDA Records Access Authority Under Sections 414 and 704 of the Federal Food, Drug, & Cosmetic Act (April 2014)

Final Rule: Record Availability Requirements: Establishment, Maintenance, and Availability of Records (April 2014)

Guidance for Industry: Questions and  Answers Regarding Establishment and Maintenance of Records By Persons Who Manufacture, Process, Pack, Transport, Distribute, Receive, Hold, or Import Food (Edition 5) (February 2012)  


FDA Actions on the Bioterroism Act of 2002 

Guidance for Industry and FDA Staff: Guidance for Records Access Authority Provided in Title III, Subtitle A, of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (November 2005)

Final Rule: Establishment and Maintenance of Records Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002
(December 9, 2004); Correction to the Final Rule (February 23, 2005)

Fact Sheet: FDA's New Food Bioterrorism Regulation: Establishment and Maintenance of Records (December 2004; Revised November 2005)