---
kind: "section"
citation: "21 C.F.R. § 640.72"
title: "21"
number: "640.72"
heading: "Records."
url: "https://uscodex.org/cfr/21/640.72"
---

# §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 [§ 600.15](/cfr/21/600.15.md) of this title and of [§ 640.74(b)(2)](/cfr/21/640.74.md?p=b-2) are being met for Source Plasma intended for manufacture into injectable products.
  - (2)
    - (i) For each donor, establishments must maintain records including a separate and complete record of initial and periodic examinations, tests, laboratory data, and interviews, etc., as required in §§ [630.10](/cfr/21/630.10.md) and [630.15](/cfr/21/630.15.md) of this chapter and §§ [640.65](/cfr/21/640.65.md), [640.66](/cfr/21/640.66.md), and [640.67](/cfr/21/640.67.md), except as provided in [paragraph (a)(2)(ii)](#a-2-ii) of this section.
    - (ii) Negative results for testing for evidence of infection due to relevant transfusion-transmitted infections required in [§ 610.40](/cfr/21/610.40.md) of this chapter, and the volume or weight of plasma withdrawn from a donor need not be recorded on the individual donor record if such information is maintained on the premises of the plasmapheresis center where the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 or other durable record which may be electronic of the donor's consent for participation in the plasmapheresis program or for immunization.
  - (4) Records of the medical history and physical examination of the donor conducted in accordance with [§ 630.15(b)(1)](/cfr/21/630.15.md?p=b-1) of this chapter and, where applicable, [§ 630.15(b)(5)](/cfr/21/630.15.md?p=b-5) of this chapter must document the eligibility of the donor as a plasmapheresis donor and, when applicable, as an immunized donor.
  - (5) If plasma that is reactive to a serologic test for syphilis is issued as prescribed in [§ 640.65(b)(2)(iv)](/cfr/21/640.65.md?p=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.

## Notes

### Amendments

[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; 80 FR 29905, May 22, 2015]

### Authority

Authority: 21 U.S.C. 321, 351, 352, 353, 355, 360, 371; 42 U.S.C. 216, 262, 263, 263a, 264.

### Source

Source: 38 FR 32089, Nov. 20, 1973, unless otherwise noted.

### Amendments

[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; 80 FR 29905, May 22, 2015]