# 21 C.F.R. § 630.25 (2026): Exceptions from certain donor eligibility requirements for infrequent plasma donors

> Federal · Regulations · In force

URL: https://www.frixlaw.com/law-library/statutes/CFR_T21_P630_S630_25

## Section

- **Citation:** 21 C.F.R. § 630.25 (2026)
- **Heading:** Exceptions from certain donor eligibility requirements for infrequent plasma donors
- **Jurisdiction:** Federal
- **Kind:** Regulations
- **Status:** In force
- **Text as of:** August 14, 2026
- **Source:** Compiled text
- **Location:** Title 21 CFR: Food and Drugs / Chapter I: FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES / Part 630: REQUIREMENTS FOR BLOOD AND BLOOD COMPONENTS INTENDED FOR TRANSFUSION OR FOR FURTHER MANUFACTURING USE / Subpart B: Donor Eligibility Requirements / § 630.25: § 630.25   Exceptions from certain donor eligibility requirements for infrequent plasma donors.

## 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 C.F.R. § 630.5 (2026) § 630.5   Medical supervision.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P630_S630_5.md)
- [21 C.F.R. § 630.10 (2026) § 630.10   General donor eligibility requirements.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P630_S630_10.md)
- [21 C.F.R. § 630.15 (2026) § 630.15   Donor eligibility requirements specific to Whole Blood, Red Blood Cells and Plasma collected by apheresis.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P630_S630_15.md)
- [21 C.F.R. § 630.20 (2026) § 630.20   Exceptions for certain ineligible donors.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P630_S630_20.md)
- [21 C.F.R. § 630.25 (2026) § 630.25   Exceptions from certain donor eligibility requirements for infrequent plasma donors.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P630_S630_25.md)
- [21 C.F.R. § 630.30 (2026) § 630.30   Donation suitability requirements.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P630_S630_30.md)
- [21 C.F.R. § 630.35 (2026) § 630.35   Requalification of previously deferred donors.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P630_S630_35.md)

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Source: Frix Law Library, https://www.frixlaw.com/law-library/statutes/CFR_T21_P630_S630_25. Check the current official text before relying on it. Not legal advice.
