covers the specific requirements for labeling blood components. Although this section is primarily intended for donor centers, these regulations may also apply to transfusion services that pool components or make aliquots.
In this section, you will find:
- Acceptable label colors
- Acceptable font sizes
- Statements that must be on the label
- Requirement for machine-readable information
- Emergency labeling
- Autologous unit labeling
The container label requirements are designed to facilitate the use of a uniform container label for blood and blood components (except Source Plasma) by all blood establishments.
It is important to note that the label provided by the collecting facility and the initial processing facility must not be removed, altered, or obscured. However, the label may be altered to indicate the proper name and other information required to identify accurately the contents of a container after blood components have been prepared.
Unless otherwise approved by the Director, CBER, the container label for blood and blood components intended for transfusion must be white and print must be solid black, with the following additional exceptions:
(1) The ABO and Rh blood groups must be printed as follows:
- Rh positive: Use black print on white background and use solid black or other solid color for ABO.
- Rh negative: Use white print on black background for Rh and use black outline on a white background for ABO.
(2) The proper name of the product, with any appropriate modifiers and attributes, the donor classification statement, and the statement "properly identify intended recipient" may be printed in solid red or in solid black.