CFR section
21 CFR 1271.60(c): What quarantine and other requirements apply before the donor-eligibility determination is complete?
PART 1271-HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS · Subpart C-Donor Eligibility
Key facts
| Citation | 21 CFR 1271.60(c) |
|---|---|
| Section | What quarantine and other requirements apply before the donor-eligibility determination is complete? |
| 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) | (c) Shipping of HCT/Ps in quarantine. If you ship an HCT/P before completion of the donor-eligibility determination, you must keep it in quarantine during shipment. The HCT/P must be accompanied by records: (1) Identifying the donor (e.g., by a distinct identification code affixed to the HCT/P container); (2) Stating that the donor-eligibility determination has not been completed; and (3) Stating that the product must not be implanted, transplanted, infused, or transferred until completion of… |
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