The Food and Drug
Administration (FDA) has issued an interim final rule (IFR) and draft guidance
for industry amending FDA’s existing regulation on maintaining records about
sources and recipients of food (FSMA Section 101). FDA also published an update
to its Guidance for Industry: Questions and Answers Regarding Establishment and
Maintenance of Records (Edition 4), to ensure the guidance is consistent with
the new FSMA requirements.
• Interim Final Rule: Establishment, Maintenance, andAvailability of Records: Amendment to Record
• Draft Guidance for Industry: FDA Records Access Authority Under
Sections 414 and 704 of the Federal Food, Drug, & Cosmetic Act
• 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)
