{"data":{"id":"us/21-cfr-640.6","jurisdiction":"us","citation":"21 CFR 640.6","heading":"Modifications of Whole Blood.","body":"Upon approval by the Director, Center for Biologics Evaluation and Research, of a supplement to the biologics license application for Whole Blood a manufacturer may prepare Whole Blood from which the antihemophilic factor has been removed, provided the Whole Blood meets the applicable requirements of this subchapter and the following conditions are met:\n(a) The antihemophilic factor shall be removed in accordance with paragraphs (a), (b), and (c) of § 640.52.\n(b) Although the closed system between the red blood cells and plasma shall be maintained, the red blood cells shall be maintained between 1 and 6 °C at all times, including that time when the plasma is being frozen for removal of the antihemophilic factor.","path":["Title 21—Food and Drugs","CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES","SUBCHAPTER F—BIOLOGICS","PART 640—ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS","Subpart A—Whole Blood"],"source_url":"https://www.ecfr.gov/api/versioner/v1/full/2026-08-25/title-21.xml","current_through":"2026-08-25","vintage":"","retrieved_at":"2026-08-27T02:24:47Z","sha256":"a21bc704b063133a62be390fa9f59c59b0ed8f41e2e66dbd1047a8d91d8f3480","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-640.5","next":"us/21-cfr-640.10"},"notice":"GroundRules: Original legal text. Not legal advice."}