[Code of Federal Regulations]
[Title 21, Volume 7]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR660.35]

[Page 115-116]
 
                        TITLE 21--FOOD AND DRUGS
 
          DEPARTMENT OF HEALTH AND HUMAN SERVICES--(Continued)
 
PART 660--ADDITIONAL STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS--Table of Contents
 
                   Subpart D--Reagent Red Blood Cells
 
Sec. 660.35  Labeling.

    In addition to the items required by Sec. 809.10 of this chapter and 
other applicable labeling provisions of this chapter, the following 
information shall be included in the labeling:
    (a)(1) A logo or company name may be placed on the final container 
label, however, the logo or company name shall be located along the 
bottom or end of the label, oustide of the main panel.
    (2) If washing the cells is required by the manufacturer, the 
container label shall include appropriate instructions; if the cells 
should not be washed before use, e.g., if washing will adversely affect 
the product, the package insert shall explain.
    (b) The container label of Group O cells shall state:

``FOR USE IN DETECTION OF UNEXPECTED ANTIBODIES'' or ``FOR USE IN 
IDENTIFICATION OF UNEXPECTED ANTIBODIES'' or ``NOT FOR USE IN DETECTION 
OR IDENTIFICATION OF UNEXPECTED ANTIBODIES''.

    (c) Except as provided in this section, the container and package 
labels shall state the percentage of red blood cells in the suspension 
either as a discrete figure with a variance of more than 1 
percentage unit or as a range the extremes of which differ by no more 
than 2 percentage units. If the stated red blood cell concentration is 
less than 2 percent, the variance shall be no more than 0.5 
percentage unit.
    (d) The words ``pooled cells'' shall appear on the container and 
package labels of products prepared from pooled cells. The package label 
or package insert shall state that pooled cells are not recommended for 
pretransfusion tests, done in lieu of a major crossmatch, to detect 
unexpected antibodies in patients' samples.
    (e) The package insert of a pooled product intended for detection of 
unexpected antibodies shall identify the number of donors contributing 
to the pool. Products designed exclusively for ABO Serum Grouping and 
umbilical cord cells need not identify the number of donors in the pool.
    (f) When the product is a multicontainer product, e.g., a cell 
panel, the container label and package label shall be assigned the same 
identifying lot number, and shall also bear a number or symbol to 
distinguish one container from another. Such number or symbol shall also 
appear on the antigenic constitution matrix.
    (g) The package label or package insert shall state the blood group 
antigens that have been tested for and found present or absent on the 
cells of each donor, or refer to such information in an accompanying 
antigenic constitution matrix. Cells for ABO Serum Grouping are exempt 
from this requirement. The package insert or antigen constitution matrix 
shall list each of

[[Page 116]]

the antigens tested with only one source of antibody.
    (h) The package label or package insert shall bear the cautionary 
statement: ``The reactivity of the product may decrease during the 
dating period.''
    (i) The package insert of a product intended for the detection or 
identification of unexpected antibodies shall note that the rate at 
which antigen reactivity (e.g., agglutinability) is lost is partially 
dependent upon individual donor characteristics that are neither 
controlled nor predicted by the manufacturer.
    (j) The package insert shall provide adequate directions for use.
    (k) The package insert shall bear the statement:

``CAUTION: ALL BLOOD PRODUCTS SHOULD BE TREATED AS POTENTIALLY 
INFECTIOUS. SOURCE MATERIAL FROM WHICH THIS PRODUCT WAS DERIVED WAS 
FOUND NEGATIVE WHEN TESTED IN ACCORDANCE WITH CURRENT FDA REQUIRED 
TESTS. NO KNOWN TEST METHODS CAN OFFER ASSURANCE THAT PRODUCTS DERIVED 
FROM HUMAN BLOOD WILL NOT TRANSMIT INFECTIOUS AGENTS.''

    (l) The package insert or the antigenic constitution matrix for each 
lot of product shall specify the date of manufacture or the length of 
the dating period.
    (m) Manufacturers shall identify with a permanent donor code in the 
product labeling each donor of peripheral blood used for detection or 
identification of unexpected antibodies.

(Approved by the Office of Management and Budget under control number 
0910-0073)