[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: 21CFR640.72]

[Page 100-101]
 
                        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 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.

[[Page 101]]

    (2) For each donor, a separate and complete record of all initial 
and periodic examinations, tests, laboratory data, interviews, etc., 
undertaken pursuant to Secs. 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withdrawn from a donor need not be kept on the individual donor record: 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.
    (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.

(Collection of information requirements approved by the Office of 
Management and Budget under control number 0910-0227)

[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]