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 Part 640 · Additional Standards for Human Blood and Blood Products
§ 640.60 Source Plasma
Independent copy, not an official legal edition. 21 CFR is a U.S. Government work in the public domain; this text comes from the eCFR and the annual CFR edition, and may lag recent amendments. The authoritative version is on ecfr.gov. Compliome is not affiliated with or endorsed by FDA. Not legal advice.
FDA guidance that cites § 640.60
- Considerations for the Use of Human-and Animal-Derived Materials in the Manufacture of Cell and Gene Therapy and Tissue-Engineered Medical Products draft 29 Apr 2024
Amendment history
Federal Register documents that created or amended this section.
- 41 FR 10768 12 Mar 1976
- 50 FR 4140 29 Jan 1985