# 21 CFR § 630.25: Exceptions from certain donor eligibility requirements for infrequent plasma donors

> Federal · Regulations · In force

URL: https://www.frixlaw.com/law-library/statutes/ecfr-21-630.25

## Section

- **Citation:** 21 CFR § 630.25
- **Heading:** Exceptions from certain donor eligibility requirements for infrequent plasma donors
- **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 630—REQUIREMENTS FOR BLOOD AND BLOOD COMPONENTS INTENDED FOR TRANSFUSION OR FOR FURTHER MANUFACTURING USE > Subpart B—Donor Eligibility Requirements

## Text

For an infrequent plasma donor who is not participating in an immunization program, establishments are not required to:
(a) Perform a medical history and physical examination of the donor under § 630.15(b)(1);
(b) Perform a test for total protein under § 630.15(b)(4);
(c) Determine the total plasma or serum protein and immunoglobulin composition under § 640.65(b)(1)(i) of this chapter; or
(d) Review the data and records as required in § 640.65(b)(2)(i) of this chapter.

## Nearby sections

- [21 CFR § 630.1 § 630.1 Purpose and scope.](https://www.frixlaw.com/law-library/statutes/ecfr-21-630.1.md)
- [21 CFR § 630.3 § 630.3 Definitions.](https://www.frixlaw.com/law-library/statutes/ecfr-21-630.3.md)
- [21 CFR § 630.5 § 630.5 Medical supervision.](https://www.frixlaw.com/law-library/statutes/ecfr-21-630.5.md)
- [21 CFR § 630.10 § 630.10 General donor eligibility requirements.](https://www.frixlaw.com/law-library/statutes/ecfr-21-630.10.md)
- [21 CFR § 630.15 § 630.15 Donor eligibility requirements specific to Whole Blood, Red Blood Cells and Plasma collected by apheresis.](https://www.frixlaw.com/law-library/statutes/ecfr-21-630.15.md)
- [21 CFR § 630.20 § 630.20 Exceptions for certain ineligible donors.](https://www.frixlaw.com/law-library/statutes/ecfr-21-630.20.md)
- [21 CFR § 630.25 § 630.25 Exceptions from certain donor eligibility requirements for infrequent plasma donors.](https://www.frixlaw.com/law-library/statutes/ecfr-21-630.25.md)
- [21 CFR § 630.30 § 630.30 Donation suitability requirements.](https://www.frixlaw.com/law-library/statutes/ecfr-21-630.30.md)
- [21 CFR § 630.35 § 630.35 Requalification of previously deferred donors.](https://www.frixlaw.com/law-library/statutes/ecfr-21-630.35.md)
- [21 CFR § 630.40 § 630.40 Requirements for notifying deferred donors.](https://www.frixlaw.com/law-library/statutes/ecfr-21-630.40.md)

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Source: Frix Law Library, https://www.frixlaw.com/law-library/statutes/ecfr-21-630.25. Check the current official text before relying on it. Not legal advice.