21 CFR § 121.315 - Requirements for record retention.

---
identifier: "/us/cfr/t21/s121.315"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 121.315 - Requirements for record retention."
title_number: 21
title_name: "Food and Drugs"
section_number: "121.315"
section_name: "Requirements for record retention."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "B"
subchapter_name: "FOOD FOR HUMAN CONSUMPTION"
part_number: "121"
part_name: "MITIGATION STRATEGIES TO PROTECT FOOD AGAINST INTENTIONAL ADULTERATION"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 331, 342, 350g, 350(i), 371, 374."
regulatory_source: "81 FR 34219, May 27, 2016, unless otherwise noted."
cfr_part: "121"
---


# 121.315 Requirements for record retention.

(a)(1) All records required by this part must be retained at the facility for at least 2 years after the date they were prepared.

(2) Records that a facility relies on during the 3-year period preceding the applicable calendar year to support its status as exempt as a very small business must be retained at the facility as long as necessary to support the status of a facility as a very small business during the applicable calendar year.

(b) The food defense plan must be retained for at least 2 years after its use is discontinued.

(c) Except for the food defense plan, offsite storage of records is permitted if such records can be retrieved and provided onsite within 24 hours of request for official review. The food defense plan must remain onsite. Electronic records are considered to be onsite if they are accessible from an onsite location.

(d) If the facility is closed for a prolonged period, the food defense plan may be transferred to some other reasonably accessible location but must be returned to the facility within 24 hours for official review upon request.