21 CFR 640.22

§ 640.22 Collection of source material.

United States · 21 CFR — Food and Drugs · Status: effective

Cite this

Citation: 21 CFR 640.22, § 640.22 Collection of source material, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/88479
Permanent ID: ys:prov:88479@1
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Full text

(a) Whole blood used as the source of Platelets shall be collected as prescribed in § 640.4. (b) [Reserved] (c) If plateletpheresis is used, the procedure for collection must be as prescribed in §§ 640.21, 640.64 (except paragraph (c)), and 640.65, or as described in an approved biologics license application (BLA) or an approved supplement to a BLA. (d) The phlebotomy shall be performed by a single uninterrupted venipuncture with minimal damage to, and minimal manipulation of, the donor's tissue.

Legislative history

This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.