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SMALL ENTITY COMPLIANCE GUIDE

Small Entity Compliance Guide: What You Need to Know About Establishment and Maintenance of Records April 2014

Final
Docket Number:
FDA-2013-N-1421
Issued by:
Guidance Issuing Office
Center for Food Safety and Applied Nutrition
Center for Veterinary Medicine
Office of Regulatory Affairs

On February 23, 2012, the Food and Drug Administration (FDA) published an interim final rule (IFR) in the Federal Register (77 FR 10658) that amended its regulation on the availability of records to be consistent with the amendments to section 414(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) made by section 101 of the FDA Food Safety Modernization Act (FSMA) (Public Law 111-353). The IFR became effective on March 1, 2012.  On April 4, 2014, FDA issued a final rule in the Federal Register adopting without change the requirements in the IFR.

Previously, this guidance document, issued in December 2004, served as the Small Entity Compliance Guide (SECG) for 21 CFR Part 1, Subpart J in accordance with section 212 of the Small Business Regulatory Enforcement Fairness Act (Public Law 104-121). The SECG restated in plain language the legal requirements for the establishment and maintenance of records set forth in 21 CFR Part 1, Subpart J implementing section 414 of the FD&C Act, as added by the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act) (Public Law 107-188). Because FDA issued an IFR and subsequent final rule amending certain requirements in 21 CFR Part 1, Subpart J to be consistent with the amendments to section 414(a) of the FD&C Act made by section 101 of FSMA, FDA is updating this SECG in April 2014 to provide guidance intended to help any entity, regardless of size, comply with this regulation.  This document continues to serve as FDA’s SECG for 21 CFR Part 1, Subpart J, including the amendments to this regulation made by the IFR and finalized without change.

FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.

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All written comments should be identified with this document's docket number: FDA-2013-N-1421.