CFR section
21 CFR 1271.55(b)(4): What records must accompany an HCT/P after the donor-eligibility determination is complete; and what records must I retain?
PART 1271-HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS · Subpart C-Donor Eligibility
Key facts
| Citation | 21 CFR 1271.55(b)(4) |
|---|---|
| Section | What records must accompany an HCT/P after the donor-eligibility determination is complete; and what records must I retain? |
| Part | PART 1271-HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS |
| Subpart | Subpart C-Donor Eligibility |
| Subchapter | 21 CFR L Other |
| Product types cited | Drugs, Other_Regulations |
| Regulation text (excerpt) | (4) In the case of an HCT/P from a donor who is ineligible based on screening and released under paragraph (b) of § 1271.65, a statement noting the reason(s) for the determination of ineligibility. |
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