---
kind: "section"
citation: "21 C.F.R. § 1271.260"
title: "21"
number: "1271.260"
heading: "Storage."
url: "https://uscodex.org/cfr/21/1271.260"
---

# §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.

## Notes

### Source

Source: 69 FR 68681, Nov. 24, 2004, unless otherwise noted.

### Authority

Authority: 42 U.S.C. 216, 243, 263a, 264, 271.

### Source

Source: 66 FR 5466, Jan. 19, 2001, unless otherwise noted.