Source: https://www.law.cornell.edu/cfr/text/21/640.4
Timestamp: 2017-06-23 02:09:37
Document Index: 252114513

Matched Legal Cases: ['art 640', '§ 640', '§ 600', '§ 630', 'art 640', 'arts 606', 'arts 606']

21 CFR 640.4 - Collection of the blood. | US Law | LII / Legal Information Institute
CFR › Title 21 › Chapter I › Subchapter F › Part 640 › Subpart A › Section 640.4 21 CFR 640.4 - Collection of the blood.
§ 640.4 Collection of the blood.
(a) [Reserved] (b)The donor center. The pertinent requirements of §§ 600.10 and 600.11 of this chapter shall apply at both the blood establishment and at any other place where the bleeding is performed.
(c)Blood containers. Blood containers and donor sets shall be pyrogen-free, sterile and identified by lot number. The amount of anticoagulant required for the quantity of blood to be collected shall be in the blood container when it is sterilized. In addition, all container and donor set surfaces that come in contact with blood used in the processing of Heparin Whole Blood shall be water repellent. (d)The anticoagulant solution. The anticoagulant solution shall be sterile and pyrogen-free. Anticoagulant solutions shall be compounded and used according to a formula approved by the Director, Center for Biologics Evaluation and Research.
(e)Donor identification. Each unit of blood shall be so marked or identified by number or other symbol as to relate it to the individual donor whose identity shall be established to the extent necessary for compliance with § 630.10 of this chapter. (f)Prevention of contamination of the blood. The skin of the donor at the site of phlebotomy shall be prepared thoroughly and carefully by a method that gives maximum assurance of a sterile container of blood. The blood shall be collected by aseptic methods in a sterile system which may be closed or may be vented if the vent protects the blood against contamination.
(g)Samples and segments for laboratory tests. Samples and segments for laboratory tests shall meet the following standards:
(3) All containers for all samples shall bear the donor's identification before collecting the samples. (4) All segments accompanying a unit of blood shall be attached to the whole blood container before blood collection, in a tamperproof manner that will conspicuously indicate removal and reattachment.
(h)Storage. Whole Blood must be placed in storage at a temperature between 1 and 6 °C immediately after collection unless the blood is to be further processed into another component or the blood must be transported from the donor center to the processing laboratory. If transported, the blood must be placed in temporary storage having sufficient refrigeration capacity to cool the blood continuously toward a temperature range between 1 and 10 °C until arrival at the processing laboratory. At the processing laboratory, the blood must be stored at a temperature between 1 and 6 °C. Blood from which a component is to be prepared must be held in an environment maintained at a temperature range specified for that component in the directions for use for the blood collecting, processing, and storage system approved for such use by the Director, CBER.
[ 38 FR 32089, Nov. 20, 1973, as amended at 42 FR 59878, Nov. 22, 1977; 43 FR 34460, Aug. 4, 1978; 49 FR 23834, June 8, 1984; 50 FR 4138, Jan. 29, 1985; 55 FR 11013, Mar. 26, 1990; 64 FR 45372, Aug. 19, 1999; 66 FR 1836, Jan. 10, 2001; 66 FR 40889, Aug. 6, 2001; 72 FR 45887, Aug. 16, 2007; 73 FR 7464, Feb. 8, 2008; 80 FR 29904, May 22, 2015]
Title 21 published on 10-May-2017 03:43The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 640 after this date.2015-05-22; vol. 80 # 99 - Friday, May 22, 201580 FR 29842 - Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use
2012-02-08; vol. 77 # 26 - Wednesday, February 8, 201277 FR 6463 - Revisions to Labeling Requirements for Blood and Blood Components, Including Source Plasma; Correction
typeregulations.gov FR Doc.2012-2828 RIN Docket No.FDA-2003-N-0097 Formerly2003N-0211 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule; correction. This rule is effective July 2, 2012. 21 CFR Parts 606, 610, and 640 SummaryThe Food and Drug Administration (FDA) is correcting a final rule that appeared in the Federal Register of January 3, 2012. In the Federal Register of January 3, 2012, FDA published a final rule entitled “Revisions to Labeling Requirements for Blood and Blood Components, Including Source Plasma,” which provided incorrect publication information regarding a 60-day notice that announced the availability of an opportunity for public comment on the proposed collection of certain information by FDA pertaining to the final rule. This document corrects this error. Elsewhere in this issue of the Federal Register, FDA is publishing a companion 60-day correction notice.
2012-01-03; vol. 77 # 1 - Tuesday, January 3, 201277 FR 7 - Revisions to Labeling Requirements for Blood and Blood Components, Including Source Plasma
typeregulations.gov FR Doc.2011-33554 RIN Docket No.FDA-2003-N-0097 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective July 2, 2012. 21 CFR Parts 606, 610, and 640 SummaryThe Food and Drug Administration (FDA) is revising the labeling requirements for blood and blood components intended for use in transfusion or for further manufacture by combining, simplifying, and updating specific regulations applicable to labeling and circulars of information. These requirements will facilitate the use of a labeling system using machine-readable information that would be acceptable as a replacement for the “ABC Codabar” system for the labeling of blood and blood components. FDA is taking this action as a part of its efforts to comprehensively review and, as necessary, revise its regulations, policies, guidances, and procedures related to the regulation of blood and blood components. This final rule is intended to help ensure the continued safety of the blood supply and facilitate consistency in labeling.
21 CFR 640.13 — Collection of the Blood.
21 CFR 640.52 — Collection of Source Material.
21 CFR 640.32 — Collection of Source Material.
21 CFR 660.32 — Collection of Source Material.
21 CFR 640.22 — Collection of Source Material.