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Electronic Code of Federal Regulations
Title 21: Food and Drugs
(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 §600.15 of this title and of §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 §§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results for hepatitis B surface antigen, negative test results for antibody to HIV, and the volume or weight of plasma withdrawn from a donor need not be kept on the individual donor record: Provided, That such information is maintained on the premises of the plasmapheresis center where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 §640.63(b)(3).
(5) If plasma that is reactive to a serologic test for syphilis is issued as prescribed in §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]