---
kind: "section"
citation: "21 C.F.R. § 606.110"
title: "21"
number: "606.110"
heading: "Plateletpheresis, leukapheresis, and plasmapheresis."
url: "https://uscodex.org/cfr/21/606.110"
---

# §606.110. Plateletpheresis, leukapheresis, and plasmapheresis.

- (a) The use of plateletpheresis and leukapheresis procedures to obtain a product for a specific recipient may be at variance with the additional standards for specific products prescribed in this part provided that: (1) A physician has determined that the recipient must be transfused with the leukocytes or platelets from a specific donor, and (2) the procedure is performed under the supervision of a responsible physician who is aware of the health status of the donor, and the physician has determined and documented that the donor's health permits plateletpheresis or leukapheresis.
- (b) Plasmapheresis of donors who do not meet the donor requirements of §§ [630.10](/cfr/21/630.10.md), [630.15](/cfr/21/630.15.md), [640.64](/cfr/21/640.64.md) and [640.65](/cfr/21/640.65.md) of this chapter for the collection of plasma containing rare antibodies shall be permitted only with the prior approval of the Director, Center for Biologics Evaluation and Research.

## Notes

### Amendments

[40 FR 53532, Nov. 18, 1975, as amended at 49 FR 23833, June 8, 1984; 55 FR 11013, Mar. 26, 1990; 80 FR 29895, May 22, 2015]

### Authority

Authority: 21 U.S.C. 321, 331, 351, 352, 355, 360, 360j, 371, 374; 42 U.S.C. 216, 262, 263a, 264.

### Source

Source: 40 FR 53532, Nov. 18, 1975, unless otherwise noted.

### Amendments

[40 FR 53532, Nov. 18, 1975, as amended at 49 FR 23833, June 8, 1984; 55 FR 11013, Mar. 26, 1990; 80 FR 29895, May 22, 2015]