[Code of Federal Regulations]
[Title 21, Volume 7]
[Revised as of April 1, 2005]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR640.72]

[Page 107-108]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 640_ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS
--Table of Contents
 
                         Subpart G_Source Plasma
 
Sec. 640.72  Records.

    (a) In addition to the recordkeeping requirements of this 
subchapter, the following records shall be maintained:
    (1) Documentation shall be available to ensure that the shipping 
temperature requirements of Sec. 600.15 of this title and of Sec. 
640.74(b)(2) are being met for Source Plasma intended for manufacture 
into injectable products.
    (2) For each donor, a separate and complete record of all initial 
and periodic examinations, tests, laboratory data, interviews, etc., 
undertaken pursuant to Sec. Sec. 640.63, 640.65, 640.66, and 640.67, 
except that negative test results for hepatitis B surface antigen, 
negative test results for antibody to HIV, and the volume or weight of 
plasma withdrawn from a donor need not be kept on the individual donor 
record: Provided, That such information is maintained on the premises of 
the plasmapheresis center where the donor's plasma has been collected.

[[Page 108]]

    (3) The original or a clear copy of the donor's written consent for 
participation in the plasmapheresis program or for immunization.
    (4) The certification of the donor's good health as prescribed in 
Sec. 640.63(b)(3).
    (5) If plasma that is reactive to a serologic test for syphilis is 
issued as prescribed in Sec. 640.65(b)(2)(iv), the distribution records 
shall indicate by number those units that are reactive.
    (b) Each donor record must be directly cross-referenced to the 
unit(s) of Source Plasma associated with the donor.
    (c) If a repeat donor is rejected or a donor's plasma is found 
unsuitable, the donor's record shall contain a full explanation for the 
rejection.
    (d) If a donor has a reaction while on the plasmapheresis premises, 
or a donor reaction is reported to the center after the donor has left 
the premises, the donor's record shall contain a full explanation of the 
reaction, including the measures taken to assist the donor and the 
outcome of the incident.

[41 FR 10770, Mar. 12, 1976, as amended at 50 FR 4140, Jan. 29, 1985; 53 
FR 117, Jan. 5, 1988; 64 FR 45374, Aug. 19, 1999; 67 FR 9587, Mar. 4, 
2002]