CFR section
21 CFR 640.32(a): Collection of source material
PART 640-ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS · Subpart D-Plasma
Key facts
| Citation | 21 CFR 640.32(a) |
|---|---|
| Section | Collection of source material |
| Part | PART 640-ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS |
| Subpart | Subpart D-Plasma |
| Subchapter | 21 CFR F Biologics |
| Product types cited | Biologics |
| Regulation text (excerpt) | (a) Whole Blood must be collected, transported, and stored as prescribed in § 640.4. When whole blood is intended for Plasma, Fresh Frozen Plasma, and Liquid Plasma, until the plasma is removed, the whole blood must be maintained at a temperature between 1 and 6 °C or as specified in the directions for use for the blood collecting, processing, and storage system approved for such use by the Director, Center for Biologics Evaluations and Research. Whole blood intended for Platelet Rich Plasma… |
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