[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2005]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR1271.260]

[Page 735]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 1271_HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS
--Table of Contents
 
                 Subpart D_Current Good Tissue Practice
 
Sec. 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.