21 CFR § 630.1 - Purpose and scope.

---
identifier: "/us/cfr/t21/s630.1"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 630.1 - Purpose and scope."
title_number: 21
title_name: "Food and Drugs"
section_number: "630.1"
section_name: "Purpose and scope."
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"
---


# 630.1 Purpose and scope.

(a) *What is the purpose of subparts A, B, and C of this part*? The purpose of these subparts, together with §§ 610.40 and 610.41 of this chapter, is to provide certain minimum criteria for each donation of blood and blood components, for:

(1) Determining the eligibility of a donor of blood and blood components;

(2) Determining the suitability of the donation of blood and blood components; and

(3) Notifying a donor who is deferred from donation.

(b) *Who must comply with subparts A, B, and C of this part*? Blood establishments that manufacture blood and blood components, as defined in § 630.3(a) and (b), must comply with subparts A, B, and C of this part.