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.

Title 21 published on 2014-04-01

no entries appear in the Federal Register after this date.

This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.

This list is taken from the Parallel Table of Authorities and Rules provided by GPO [Government Printing Office].

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United States Code

Title 21 published on 2014-04-01

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

  • 2014-10-23; vol. 79 # 205 - Thursday, October 23, 2014
    1. 79 FR 63348 - Same Surgical Procedure Exception Questions and Answers Regarding the Scope of the Exception; Draft Guidance for Industry; Availability
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Request for comment on draft guidance.
      Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by December 22, 2014
      21 CFR Part 1271