№ lp_2_3_18351
Regulatory donor screening questionnaire and decision flowchart outlining eligibility criteria and deferral periods for blood and blood component donation under U.S. federal regulations and FDA guidance.
Country: United States
Issuing authority: U.S. Food and Drug Administration
Regulatory references: 21 CFR 630.10; 21 CFR 630.15; 21 CFR 640.21
Guidance documents referenced: FDA December 2002 Guidance on Smallpox Vaccine; FDA December 2007 Guidance on Collection of Platelets by Automated Methods; FDA 2023 Guidance on Individual Risk-Based Questions for HIV
Related organization: AABB
Subject: Blood donor eligibility and deferral criteria
Document type: Donor screening questionnaire and decision flowchart
Intended users: Blood establishments and donor screening personnel
Scope: Assessment of donor health status, pregnancy, educational materials review, aspirin use, prior donations, and recent vaccinations
Deferral periods specified: 6 weeks after pregnancy; 8 weeks between certain donations; 21 or 56 days after smallpox vaccination; 14 days after resolution of vaccine-related illness
Price: 8 / 10 USD
The file will be delivered to the email address provided at checkout within 12 hours.

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