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Code of Federal Regulations (Last Updated: November 8, 2024) |
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Title 21 - Food and Drugs |
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Chapter I - Food and Drug Administration, Department of Health and Human Services |
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SubChapter L - Regulations Under Certain Other Acts Administered by the Food and Drug Administration |
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Part 1271 - Human Cells, Tissues, and Cellular and Tissue-Based Products |
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Subpart C - Donor Eligibility |
| § 1271.45 - What requirements does this subpart contain? |
| § 1271.47 - What procedures must I establish and maintain? |
| § 1271.50 - How do I determine whether a donor is eligible? |
| § 1271.55 - What records must accompany an HCT/P after the donor-eligibility determination is complete; and what records must I retain? |
| § 1271.60 - What quarantine and other requirements apply before the donor-eligibility determination is complete? |
| § 1271.65 - How do I store an HCT/P from a donor determined to be ineligible, and what uses of the HCT/P are not prohibited? |
| § 1271.75 - How do I screen a donor? |
| § 1271.80 - What are the general requirements for donor testing? |
| § 1271.85 - What donor testing is required for different types of cells and tissues? |
| § 1271.90 - Are there other exceptions and what labeling requirements apply? |