21 CFR § 640.1 - Whole Blood.

---
identifier: "/us/cfr/t21/s640.1"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 640.1 - Whole Blood."
title_number: 21
title_name: "Food and Drugs"
section_number: "640.1"
section_name: "Whole Blood."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "F"
subchapter_name: "BIOLOGICS"
part_number: "640"
part_name: "ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS"
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, 351, 352, 353, 355, 360, 371; 42 U.S.C. 216, 262, 263, 263a, 264."
regulatory_source: "38 FR 32089, Nov. 20, 1973, unless otherwise noted."
cfr_part: "640"
---


# 640.1 Whole Blood.

The proper name of this product shall be Whole Blood. Whole Blood is defined as blood collected from human donors for transfusion to human recipients.

[38 FR 32089, Nov. 20, 1973, as amended at 50 FR 4138, Jan. 29, 1985]