21 CFR 640.60

§ 640.60 Source Plasma.

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

Cite this

Citation: 21 CFR 640.60, § 640.60 Source Plasma, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/88499
Permanent ID: ys:prov:88499@1
SHA-256: d29f4d7ae3c54bffdcad9318426f99ea988105705f69b4db25cc3a16b0673d2f

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Full text

The proper name of the product shall be Source Plasma. The product is defined as the fluid portion of human blood collected by plasmapheresis and intended as source material for further manufacturing use. The definition excludes single donor plasma products intended for intravenous use.

Legislative history

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