21 CFR § 640.60 Additional Standards for Human Blood and Blood Products

§ 640.60 Source Plasma.

Current through Sep 8, 2026 · Read all of Part 640

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.

[41 FR 10768, Mar. 12, 1976, as amended at 50 FR 4140, Jan. 29, 1985]

← § 640.56 Quality control test for potency.§ 640.64 Collection of blood for Source Plasma. →