21 CFR 640.32
§ 640.32 Collection of source material.
United States · 21 CFR — Food and Drugs · Status: effective
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- Citation
- 21 CFR 640.32, § 640.32 Collection of source material, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/88486
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Full text
(a) Whole Blood must be collected, transported, and stored as prescribed in § 640.4. When whole blood is intended for Plasma, Fresh Frozen Plasma, and Liquid Plasma, until the plasma is removed, the whole blood must be maintained at a temperature between 1 and 6 °C or as specified in the directions for use for the blood collecting, processing, and storage system approved for such use by the Director, Center for Biologics Evaluations and Research. Whole blood intended for Platelet Rich Plasma must be maintained as prescribed in § 640.24 until the plasma is removed. The red blood cells must be placed in storage at a temperature between 1 and 6 °C immediately after the plasma is separated.
(b) Plasma obtained by plasmapheresis shall be collected as prescribed in § 640.64 (except that paragraph (c)(3) of § 640.64 shall not apply), and § 640.65.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.