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.

• Interim Final Rule: Establishment, Maintenance, and Availability of Records: Amendment to Record (February 2012)
• Draft Guidance for Industry: FDA Records Access Authority Under Sections 414 and 704 of the Federal Food, Drug, & Cosmetic Act (February 2012)
• 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: Questions and Answers Regarding Establishment and Maintenance of Records (Edition 4)
  September 21, 2006
• 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
• Booklet (SECG): What You Need to Know About Establishment and Maintenance of Records
  December 2004
• Fact Sheet: FDA's New Food Bioterrorism Regulation: Establishment and Maintenance of Records
  December 2004; Revised November 2005

• Slide Presentation: Overview of Bioterrorism Act's Establishment and Maintenance of Records Final Rule (PPT 1.0MG) June 2005