21 CFR 1271.260 - Storage.

§ 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.
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§ 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.

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United States Code

Title 21 published on 2015-04-01

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 1271 after this date.

  • 2015-10-30; vol. 80 # 210 - Friday, October 30, 2015
    1. 80 FR 66844 - Minimal Manipulation of Human Cells, Tissues, and Cellular and Tissue-Based Products; Draft Guidance for Industry and Food and Drug Administration Staff; Reopening of the Comment Period
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Notification; reopening of the comment period.
      Submit either electronic or written comments on the draft guidance by April 29, 2016.
      21 CFR Part 1271