---
kind: "section"
citation: "21 C.F.R. § 640.22"
title: "21"
number: "640.22"
heading: "Collection of source material."
url: "https://uscodex.org/cfr/21/640.22"
---

# §640.22. Collection of source material.

- (a) Whole blood used as the source of Platelets shall be collected as prescribed in [§ 640.4](/cfr/21/640.4.md).
- (b) [Reserved]
- (c) If plateletpheresis is used, the procedure for collection must be as prescribed in §§ [640.21](/cfr/21/640.21.md), [640.64](/cfr/21/640.64.md) (except [paragraph (c)](#c)), and 640.65, or as described in an approved biologics license application (BLA) or an approved supplement to a BLA.
- (d) The phlebotomy shall be performed by a single uninterrupted venipuncture with minimal damage to, and minimal manipulation of, the donor's tissue.

## Notes

### Amendments

[40 FR 4304, Jan. 29, 1975, as amended at 45 FR 27927, Apr. 25, 1980; 49 FR 23834, June 8, 1984; 50 FR 4139, Jan. 29, 1985; 55 FR 11013, Mar. 26, 1990; 59 FR 49351, Sept. 28, 1994; 64 FR 45372, Aug. 19, 1999; 64 FR 56453, Oct. 20, 1999; 72 FR 45887, Aug. 16, 2007; 80 FR 29904, 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

[40 FR 4304, Jan. 29, 1975, as amended at 45 FR 27927, Apr. 25, 1980; 49 FR 23834, June 8, 1984; 50 FR 4139, Jan. 29, 1985; 55 FR 11013, Mar. 26, 1990; 59 FR 49351, Sept. 28, 1994; 64 FR 45372, Aug. 19, 1999; 64 FR 56453, Oct. 20, 1999; 72 FR 45887, Aug. 16, 2007; 80 FR 29904, May 22, 2015]