---
kind: "section"
citation: "21 C.F.R. § 640.64"
title: "21"
number: "640.64"
heading: "Collection of blood for Source Plasma."
url: "https://uscodex.org/cfr/21/640.64"
---

# §640.64. Collection of blood for Source Plasma.

- (a) [Reserved]
- (b) **Blood containers.** Blood containers and donor sets must be pyrogen-free, sterile, and identified by lot number.
- (c) **The anticoagulant solution.** The anticoagulant solution must be sterile and pyrogen-free. Anticoagulant solutions must be compounded and used according to a formula that has been approved for the applicant by the Director, Center for Biologics Evaluation and Research.
- (d) **Donor identification.** Each unit of blood and plasma shall be so marked or identified by number or other symbol so as to relate it directly to the donor.
- (e) **Prevention of contamination of the blood and plasma.** The skin of the donor at the site of phlebotomy shall be prepared thoroughly and carefully by a method that gives maximum assurance of a sterile container of blood. The blood shall be collected, the plasma separated, and the cells returned to the donor by aseptic methods in a sterile system which may be closed, or may be vented if the vent protects the blood cells and plasma against contamination.

## Notes

### Amendments

[38 FR 32089, Nov. 20, 1973; 39 FR 13632, Apr. 16, 1974, as amended at 41 FR 10768, Mar. 12, 1976; 49 FR 23834, June 8, 1984; 50 FR 4140, Jan. 29, 1985; 55 FR 11013, Mar. 26, 1990; 59 FR 49351, Sept. 28, 1994; 63 FR 16685, Apr. 6, 1998; 64 FR 56453, Oct. 20, 1999; 72 FR 45888, Aug. 16, 2007; 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

[38 FR 32089, Nov. 20, 1973; 39 FR 13632, Apr. 16, 1974, as amended at 41 FR 10768, Mar. 12, 1976; 49 FR 23834, June 8, 1984; 50 FR 4140, Jan. 29, 1985; 55 FR 11013, Mar. 26, 1990; 59 FR 49351, Sept. 28, 1994; 63 FR 16685, Apr. 6, 1998; 64 FR 56453, Oct. 20, 1999; 72 FR 45888, Aug. 16, 2007; 80 FR 29905, May 22, 2015]