CFR section
21 CFR 630.15(b)(3): Donor eligibility requirements specific to Whole Blood, Red Blood Cells and Plasma collected by apheresis
PART 630-REQUIREMENTS FOR BLOOD AND BLOOD COMPONENTS INTENDED FOR TRANSFUSION OR FOR FURTHER MANUFACTURING USE · Subpart B-Donor Eligibility Requirements
Key facts
| Citation | 21 CFR 630.15(b)(3) |
|---|---|
| Section | Donor eligibility requirements specific to Whole Blood, Red Blood Cells and Plasma collected by apheresis |
| Part | PART 630-REQUIREMENTS FOR BLOOD AND BLOOD COMPONENTS INTENDED FOR TRANSFUSION OR FOR FURTHER MANUFACTURING USE |
| Subpart | Subpart B-Donor Eligibility Requirements |
| Subchapter | 21 CFR F Biologics |
| Product types cited | Biologics |
| Regulation text (excerpt) | (3) Weight. You must weigh a donor at each donation. |
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Title 21 of the Code of Federal Regulations contains the FDA's regulations, including current good manufacturing practice and quality system requirements that inspections cite.