21 CFR § 1271.260 - Storage.

---
identifier: "/us/cfr/t21/s1271.260"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 1271.260 - Storage."
title_number: 21
title_name: "Food and Drugs"
section_number: "1271.260"
section_name: "Storage."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "L"
subchapter_name: "REGULATIONS UNDER CERTAIN OTHER ACTS ADMINISTERED BY THE FOOD AND DRUG ADMINISTRATION"
part_number: "1271"
part_name: "HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "42 U.S.C. 216, 243, 263a, 264, 271."
regulatory_source: "66 FR 5466, Jan. 19, 2001, unless otherwise noted."
cfr_part: "1271"
---


# 1271.260 Storage.

(a) *Control of storage areas.* You must control your storage areas and stock rooms to prevent:

(1) Mix-ups, contamination, and cross-contamination of HCT/Ps, supplies, and reagents, and

(2) An HCT/P from being improperly made available for distribution.

(b) *Temperature.* You must store HCT/Ps at an appropriate temperature.

(c) *Expiration date.* Where appropriate, you must assign an expiration date to each HCT/P based on the following factors:

(1) HCT/P type;

(2) Processing, including the method of preservation;

(3) Storage conditions; and

(4) Packaging.

(d) *Corrective action.* You must take and document corrective action whenever proper storage conditions are not met.

(e) *Acceptable temperature limits.* You must establish acceptable temperature limits for storage of HCT/Ps at each step of the manufacturing process to inhibit the growth of infectious agents. You must maintain and record storage temperatures for HCT/Ps. You must periodically review recorded temperatures to ensure that temperatures have been within acceptable limits.