21 CFR 640.64: Collection of blood for Source Plasma
Requires Source Plasma collectors to use sterile, pyrogen-free, lot-identified containers and FDA-approved anticoagulant, label each unit traceable to its donor, and use thorough skin preparation and aseptic collection to prevent contamination.
Part 640, Additional Standards for Human Blood and Blood Products · Subpart G, Source Plasma
Recent 483s citing 640.64
- CSL Plasma Inc 3501 Cedar St Space 7 · Philadelphia, PennsylvaniaThe phlebotomy site is not prepared by a method that gives maximum assurance of a… Feb 6, 2026
- KEDPLASMA LLC · —Failure to collect blood by aseptic methods in a sterile system… Dec 16, 2025
- Central California Blood Center · Fresno, CaliforniaThe phlebotomy site is not prepared by a method that gives maximum assurance of a… Aug 29, 2025
The regulation text
§ 640.64 Collection of blood for Source Plasma.
(a)[Reserved]
(b)Blood containers. Blood containers and donor sets must be pyrogen-free, sterile, and identified by lot number.
(c)The anticoagulant solution. The anticoagulant solution must be sterile and pyrogen-free. Anticoagulant solutions must be compounded and used according to a formula that has been approved for the applicant by the Director, Center for Biologics Evaluation and Research.
(d)Donor identification. Each unit of blood and plasma shall be so marked or identified by number or other symbol so as to relate it directly to the donor.
(e)Prevention of contamination of the blood and plasma. 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, the plasma separated, and the cells returned to the donor by aseptic methods in a sterile system which may be closed, or may be vented if the vent protects the blood cells and plasma against contamination.
[38 FR 32089, Nov. 20, 1973; 39 FR 13632, Apr. 16, 1974, as amended at 41 FR 10768, Mar. 12, 1976; 49 FR 23834, June 8, 1984; 50 FR 4140, Jan. 29, 1985; 55 FR 11013, Mar. 26, 1990; 59 FR 49351, Sept. 28, 1994; 63 FR 16685, Apr. 6, 1998; 64 FR 56453, Oct. 20, 1999; 72 FR 45888, Aug. 16, 2007; 80 FR 29905, May 22, 2015]
Questions
What does 21 CFR 640.64 require?
Requires Source Plasma collectors to use sterile, pyrogen-free, lot-identified containers and FDA-approved anticoagulant, label each unit traceable to its donor, and use thorough skin preparation and aseptic collection to prevent contamination.
Which sections are cited alongside 640.64?
In the same 483s, investigators most often also cite 606.100 (Standard operating procedures), 606.171 (Reporting of product deviations by licensed manufacturers, unlicensed registered blood establishments, and transfusion services).