21 CFR § 630.25 - Exceptions from certain donor eligibility requirements for infrequent plasma donors.

---
identifier: "/us/cfr/t21/s630.25"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 630.25 - Exceptions from certain donor eligibility requirements for infrequent plasma donors."
title_number: 21
title_name: "Food and Drugs"
section_number: "630.25"
section_name: "Exceptions from certain donor eligibility requirements for infrequent plasma donors."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "F"
subchapter_name: "BIOLOGICS"
part_number: "630"
part_name: "REQUIREMENTS FOR BLOOD AND BLOOD COMPONENTS INTENDED FOR TRANSFUSION OR FOR FURTHER MANUFACTURING USE"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 321, 331, 351, 352, 355, 360, 371; 42 U.S.C. 216, 262, 264."
regulatory_source: "66 FR 31176, June 11, 2001, unless otherwise noted."
cfr_part: "630"
---


# 630.25 Exceptions from certain donor eligibility requirements for infrequent plasma donors.

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.