FDA Issues Final Rule on Record Access Requirements and Announces Guidance for Industry
CFSAN Constituent Update
April 3, 2014
The U.S. Food and Drug Administration (FDA) is issuing a final rule that affirms the interim final rule’s change to its regulations on record-keeping to be consistent with the expansion of FDA’s access to records as required by the FDA Food Safety Modernization Act (FSMA). The final rule adopts, without change, the interim final rule issued February 23, 2012.
The amendments to the Federal Food, Drug, and Cosmetic Act made by FSMA allow FDA access to records beyond those relating to specific suspect food articles if the agency reasonably believes that other food articles are likely to be affected in a similar manner. In addition, the FSMA amendments permit FDA to access records relating to articles of food for which there is a reasonable probability that the use of, or exposure to, the article of food will cause serious adverse health consequences or death to humans or animals. FDA's records access and the record-keeping requirements were first established by amendments to the FD&C Act made by the Public Health Security and Bioterrorism Preparedness and Response Act of 2002.
The expanded records-access authority is designed to improve FDA’s ability to respond to and contain safety problems with the food supply for humans and animals.
FDA is also making available a guidance document “FDA Records Access Authority under Sections 414 and 704 of the Federal Food, Drug, & Cosmetic Act,” which updates with minor changes the draft guidance issued on February 23, 2012. Comments on the guidance are being accepted.
FDA also is making available a guidance document “Why You Need to Know About Establishment, Maintenance, and Availability of Records—Small Entity Compliance Guide,” which updates the small entity compliance guide issued in December 2004. Comments on the small entity compliance guide are being accepted.
Guidance for Industry: What You Need to Know About Establishment and Maintenance of Records