CFR section

21 CFR 630.30(a)(3): 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)(3)
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) (3) The results in accordance with § 630.10(e) indicate that the donor is free from risk factors for, or evidence of, relevant transfusion-transmitted infections and other factors that make the donor ineligible to donate;

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