CFR section
21 CFR 630.30(a): Donation suitability requirements
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 630.30(a) |
|---|---|
| Section | Donation suitability requirements |
| 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) | (a) When is a donation suitable ? A donation is suitable when: (1) The donor is not currently deferred from donation as determined by review of the records of deferred donors required under § 606.160(e) of this chapter; (2) The results in accordance with §§ 630.10 through 630.25 indicate that the donor is in good health and procedures were followed to ensure that the donation would not adversely affect the health of the donor; (3) The results in accordance with § 630.10(e) indicate that the… |
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