[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: 21CFR640.15]

[Page 88]
 
                        TITLE 21--FOOD AND DRUGS
 
          DEPARTMENT OF HEALTH AND HUMAN SERVICES--(Continued)
 
PART 640--ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS--Table of Contents
 
                       Subpart B--Red Blood Cells
 
Sec. 640.15  Pilot samples.

    Pilot samples collected in integral tubing or in separate pilot 
tubes shall meet the following standards:
    (a) One or more pilot samples of either the original blood or of the 
Red Blood Cells being processed shall be provided with each unit of Red 
Blood Cells when issued or reissued.
    (b) Before they are filled, all pilot sample tubes shall be marked 
or identified so as to relate them to the donor of that unit of red 
cells.
    (c) Before the final container is filled or at the time the final 
product is prepared, the pilot sample tubes to accompany a unit of cells 
shall be attached securely to the final container in a tamper proof 
manner that will conspicuously indicate removal and reattachment.
    (d) All pilot sample tubes accompanying a unit of Red Blood Cells 
shall be filled at the time the blood is collected or at the time the 
final product is prepared, in each instance by the person who performs 
the collection or preparation.

[66 FR 1836, Jan. 10, 2001]