Section



[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: 21CFR660.28]

[Page 112-114]
 
                        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 C--Blood Grouping Reagent
 
Sec. 660.28  Labeling.

    In addition to the applicable labeling requirements of Secs. 610.62 
through 610.65 and Sec. 809.10, and in lieu of the requirements in 
Secs. 610.60 and 610.61, the following requirements shall be met:
    (a) Final container label--(1) Color coding. The final container 
label of all Blood Grouping Reagents shall be completely white, except 
that all or a portion of the final container label of the following 
Blood Grouping Reagents may be color coded with the specified color 
which shall be a visual match to a specific color sample designated by 
the Director, Center for Biologics Evaluation and Research (HFN-830), 
Food and Drug Administration, 8800 Rockville Pike, Bethesda, MD 20892. 
Printing on all final container labels shall be in solid black. 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, outside the main panel.

------------------------------------------------------------------------
          Blood grouping reagent                Color of label paper
------------------------------------------------------------------------
Anti-A....................................  Blue.
Anti-B....................................  Yellow.
Slide and rapid tube test blood grouping
 reagents only:
  Anti-C..................................  Pink.
  Anti-D..................................  Gray.
  Anti-E..................................  Brown.
  Anti-CDE................................  Orange.
  Anti-c..................................  Lavender.
  Anti-e..................................  Green.
------------------------------------------------------------------------

    (2) Required information. The proper name ``Blood Grouping Reagent'' 
need not appear on the final container label provided the final 
container is distributed in a package and the package label bears the 
proper name. The final container label shall bear the following 
information:
    (i) Name of the antibody or antibodies present as set forth in 
paragraph (d) of this section.
    (ii) Name, address (including ZIP code), and license number of the 
manufacturer.
    (iii) Lot number, including sublot designations.
    (iv) Expiration date.
    (v) Source of product if other than human plasma or serum.
    (vi) Test method(s) recommended.
    (vii) Recommended storage temperature in degrees Celsius.
    (viii) Volume of product if a liquid, or equivalent volume for a 
dried product if it is to be reconstituted.
    (ix) If a dried product, to remind users to record the 
reconstitution date on the label, the statement ``RECONSTITUTION DATE 
________. EXPIRES 1 YEAR AFTER RECONSTITUTION DATE.''
    (3) Lettering size. The type size for the specificity of the 
antibody designation on the labels of a final container with

[[Page 113]]

a capacity of less than 5 milliliters shall be not less than 12 point. 
The type size for the specificity of the antibody designations on the 
label of a container with a capacity of 5 milliliters or more shall be 
not less than 18 point.
    (4) Visual inspection. When the label has been affixed to the final 
container, a sufficient area of the container shall remain uncovered for 
its full length or no less than 5 millimeters of the lower circumference 
to permit inspection of the contents. The label on a final product 
container for antibodies Anti-c, Anti-k, or Anti-s shall display a bar 
immediately over the specificity letter used in the name, i.e., Anti-c, 
Anti-k, or Anti-s.
    (b) Package label. The following information shall appear either on 
the package label or on the final container label if it is visible 
within the package.
    (1) Proper name of the product.
    (2) Name of the antibody or antibodies present as set forth in 
paragraph (d) of this section.
    (3) Name, address (including ZIP Code), and license number of the 
manufacturer.
    (4) Lot number, including sublot designations.
    (5) Expiration date.
    (6) Preservative used and its concentration.
    (7) Number of containers, if more than one.
    (8) Volume or equivalent volume for dried products when 
reconstituted, and precautions for adequate mixing when reconstituting.
    (9) Recommended storage temperature in degrees Celsius.
    (10) Source of the product if other than human serum or plasma.
    (11) Reference to enclosed package insert.
    (12) If a dried product, a statement indicating the period within 
which the product may be used after reconstitution.
    (13) The statement: ``FOR IN VITRO DIAGNOSTIC USE.''
    (14) The statement: ``MEETS FDA POTENCY REQUIREMENTS.''
    (15) If human blood was used in manufacturing the product, 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.''
    (16) A statement of an observable indication of an alteration of the 
product, e.g., turbidity, color change, precipitate, that may indicate 
possible deterioration of the product.
    (c) Package insert. Each final container of Blood Grouping Reagent 
shall be accompanied by a package insert meeting the requirements of 
Sec. 809.10. If two or more final containers requiring identical package 
inserts are placed in a single package, only one package insert per 
package is required.
    (d) Names of antibodies.

               Blood group designation for container label

Anti-A
Anti-A1
Anti-A, B
Anti-A and B
Anti-B
Anti-C
Anti-C^w
Anti-c
Anti-CD
Anti-CDE
Anti-Co^b
Anti-D
Anti-DE
Anti-Di^a
Anti-E
Anti-e
Anti-Fy^a
Anti-Fy^b
Anti-I
Anti-Jk^a
Anti-Jk^b
Anti-Js^a
Anti-Js^b
Anti-K
Anti-k
Anti-Kp^a
Anti-Kp^b
Anti-Le^a
Anti-Le^b
Anti-Lu^a
Anti-Lu^b
Anti-M
Anti-M^g
Anti-N
Anti-P1
Anti-S
Anti-s
Anti-U

[[Page 114]]

Anti-Wr^a
Anti-Xg^a

(Information collection requirements approved by the Office of 
Management and Budget under control number 0910-0209)

[53 FR 12764, Apr. 19, 1988, as amended at 59 FR 23637, May 6, 1994]