# 21 CFR § 630.1: Purpose and scope

> Federal · Regulations · In force

URL: https://www.frixlaw.com/law-library/statutes/ecfr-21-630.1

## Section

- **Citation:** 21 CFR § 630.1
- **Heading:** Purpose and scope
- **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 A—General Provisions

## Text

(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.

## 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-21-630.1. Check the current official text before relying on it. Not legal advice.