21 CFR 640.60 : Food And Drugs (§ 1.1 To Parts 1403-1499) — (§ 600.2 To Parts 741-799) — Food And Drug Administration, Department Of Health And Human Services (Continued) (§ 600.2 To Parts 741-799) — Biologics (§ 600.2 To § 680.3) — Additional Standards For Human Blood And Blood Products (§ 640.1 To § 640.130) — Source Plasma (§ 640.60 To § 640.76) — Source Plasma.

4 Aug 2016

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.

21 CFR 640.60
[41 FR 10768, Mar. 12, 1976, as amended at 50 FR 4140, Jan. 29, 1985]