[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: 21CFR606.3]

[Page 43]
 
                        TITLE 21--FOOD AND DRUGS
 
          DEPARTMENT OF HEALTH AND HUMAN SERVICES--(Continued)
 
PART 606--CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND BLOOD COMPONENTS--Table of Contents
 
                      Subpart A--General Provisions
 
Sec. 606.3  Definitions.


    As used in this part:
    (a) Blood means whole blood collected from a single donor and 
processed either for transfusion or further manufacturing.
    (b) Unit means the volume of blood or one of its components in a 
suitable volume of anticoagulant obtained from a single collection of 
blood from one donor.
     (c) Component means that part of a single-donor's blood separated 
by physical or mechanical means.
    (d) Plasma for further manufacturing means that liquid portion of 
blood separated and used as material to prepare another product.
     (e) Plasmapheresis means the procedure in which blood is removed 
from the donor, the plasma is separated from the formed elements and at 
least the red blood cells are returned to the donor.
     (f) Plateletpheresis means the procedure in which blood is removed 
from a donor, a platelet concentrate is separated, and the remaining 
formed elements are returned to the donor along with a portion of the 
residual plasma.
    (g) Leukapheresis means the procedure in which blood is removed from 
the donor, a leukocyte concentrate is separated, and the remaining 
formed elements and residual plasma are returned to the donor.
    (h) Facilities means any area used for the collection, processing, 
compatibility testing, storage or distribution of blood and blood 
components.
    (i) Processing means any procedure employed after collection and 
before compatibility testing of blood and includes the identification of 
a unit of donor blood, the preparation of components from such unit of 
donor blood, serological testing, labeling and associated recordkeeping.
    (j) Compatibility testing means the in vitro serological tests 
performed on donor and recipient blood samples to establish the 
serological matching of a donor's blood or blood components with that of 
a potential recipient.

[40 FR 53532, Nov. 18, 1975, as amended at 64 FR 45370, Aug. 19, 1999; 
66 FR 1835, Jan. 10, 2001]

    Effective Date Note: At 65 FR 66635, Nov. 7, 2000, Sec. 606.3 was 
amended by adding paragraphs (k) and (l), effective May 7, 2000. At 65 
FR 67477, Nov. 9, 2000, the effective date was corrected to read May 7, 
2001. For the convenience of the user, the added text is set forth as 
follows:

Sec. 606.3  Definitions.

                                * * * * *

    (k) Distributed means:
    (1) The blood or blood components have left the control of the 
licensed manufacturer, unlicensed registered blood establishment, or 
transfusion service; or
    (2) The licensed manufacturer has provided Source Plasma or any 
other blood component for use in the manufacture of a licensed 
biological product.
    (l) Control means having responsibility for maintaining the 
continued safety, purity, and potency of the product and for compliance 
with applicable product and establishment standards, and for compliance 
with current good manufacturing practices.