# 21 CFR § 606.110: Plateletpheresis, leukapheresis, and plasmapheresis

> Federal · Regulations · In force

URL: https://www.frixlaw.com/law-library/statutes/ecfr-21-606.110

## Section

- **Citation:** 21 CFR § 606.110
- **Heading:** Plateletpheresis, leukapheresis, and plasmapheresis
- **Jurisdiction:** Federal
- **Kind:** Regulations
- **Status:** In force
- **Text as of:** September 22, 2026
- **Source:** Publisher's official text
- **Location:** Title 21—Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER F—BIOLOGICS > PART 606—CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND BLOOD COMPONENTS > Subpart F—Production and Process Controls

## Text

(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, 630.15, 640.64 and 640.65 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.
[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]

## Nearby sections

- [21 CFR § 606.3 § 606.3 Definitions.](https://www.frixlaw.com/law-library/statutes/ecfr-21-606.3.md)
- [21 CFR § 606.20 § 606.20 Personnel.](https://www.frixlaw.com/law-library/statutes/ecfr-21-606.20.md)
- [21 CFR § 606.40 § 606.40 Facilities.](https://www.frixlaw.com/law-library/statutes/ecfr-21-606.40.md)
- [21 CFR § 606.60 § 606.60 Equipment.](https://www.frixlaw.com/law-library/statutes/ecfr-21-606.60.md)
- [21 CFR § 606.65 § 606.65 Supplies and reagents.](https://www.frixlaw.com/law-library/statutes/ecfr-21-606.65.md)
- [21 CFR § 606.100 § 606.100 Standard operating procedures.](https://www.frixlaw.com/law-library/statutes/ecfr-21-606.100.md)
- [21 CFR § 606.110 § 606.110 Plateletpheresis, leukapheresis, and plasmapheresis.](https://www.frixlaw.com/law-library/statutes/ecfr-21-606.110.md)
- [21 CFR § 606.120 § 606.120 Labeling, general requirements.](https://www.frixlaw.com/law-library/statutes/ecfr-21-606.120.md)
- [21 CFR § 606.121 § 606.121 Container label.](https://www.frixlaw.com/law-library/statutes/ecfr-21-606.121.md)
- [21 CFR § 606.122 § 606.122 Circular of information.](https://www.frixlaw.com/law-library/statutes/ecfr-21-606.122.md)
- [21 CFR § 606.140 § 606.140 Laboratory controls.](https://www.frixlaw.com/law-library/statutes/ecfr-21-606.140.md)
- [21 CFR § 606.145 § 606.145 Control of bacterial contamination of platelets.](https://www.frixlaw.com/law-library/statutes/ecfr-21-606.145.md)
- [21 CFR § 606.151 § 606.151 Compatibility testing.](https://www.frixlaw.com/law-library/statutes/ecfr-21-606.151.md)
- [21 CFR § 606.160 § 606.160 Records.](https://www.frixlaw.com/law-library/statutes/ecfr-21-606.160.md)

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Source: Frix Law Library, https://www.frixlaw.com/law-library/statutes/ecfr-21-606.110. Check the current official text before relying on it. Not legal advice.