CFR section

21 CFR 630.10(c): General donor eligibility 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 630.10(c)
Section General donor eligibility 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) (c) When must you determine the eligibility of a donor ? You must determine donor eligibility on the day of donation, and before collection. Except: (1) When a donor is donating blood components that cannot be stored for more than 24 hours, you may determine the donor's eligibility and collect a sample for testing required under § 610.40 of this chapter, no earlier than 2 calendar days before the day of donation, provided that your standard operating procedures address these activities. (2) In…

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