On February 23, 2012, FDA issued an Interim Final Rule, effective March 1, 2012, Amending 21 CFR Part 1, Subpart J, § 1.361 to incorporate language conforming to changes made to Sections 414 and 704 of the FDCA as amended by § 101 of the FSMA.

We post below:

Federal Register Notice (77 FR 10658, 23 Feb 2012).

Draft Guidance for Industry: FDA Records Access Authority Under Sections 414 and 704 of the Federal Food, Drug, & Cosmetic Act.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

The amended text is as follows:

Title 21: Food and Drugs
Subpart J—Establishment, Maintenance, and Availability of Records
General Requirements

§ 1.361   What are the record availability requirements?

When FDA has a reasonable belief that an article of food is adulterated and presents a threat of serious adverse health consequences or death to humans or animals, any records and other information accessible to FDA under section 414 or 704(a) of the act (21 U.S.C. 350c and 374(a)) must be made readily available for inspection and photocopying or other means of reproduction. Such records and other information must be made available as soon as possible, not to exceed 24 hours from the time of receipt of the official request, from an officer or employee duly designated by the Secretary of Health and Human Services who presents appropriate credentials and a written notice.


e-CFR Data is current as of February 23, 2012