(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
(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.
The following are only the Rules published in the Federal Register after the published date of Title 21.
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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.