[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2006]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR1271]

[Page 740]
 
                        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.  1271.250  Labeling controls.

    (a) General. You must establish and maintain procedures to control 
the labeling of HCT/Ps. You must design these procedures to ensure 
proper HCT/P identification and to prevent mix-ups.
    (b) Verification. Procedures must include verification of label 
accuracy, legibility, and integrity.
    (c) Labeling requirements. Procedures must ensure that each HCT/P is 
labeled in accordance with all applicable labeling requirements, 
including those in Sec. Sec.  1271.55, 1271.60, 1271.65, 1271.90, 
1271.290, and 1271.370, and that each HCT/P made available for 
distribution is accompanied by documentation of the donor eligibility 
determination as required under Sec.  1271.55.