21 CFR Part 1271
21 CFR Part 1271
21 CFR Part 1271
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Urgent Medical Need<br />
• Allows use of products from non-eligible donors<br />
• Must be labeled “NOT EVALUATED FOR<br />
INFECTIOUS SUBSTANCES” and “WARNING:<br />
Advise patient of communicable disease risks”<br />
• Accompanied by test results and list of tests not<br />
performed, documentation of notification of<br />
physician<br />
• Must complete donor eligibility testing & inform<br />
physician of results
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