CFR section
21 CFR 1271.65(c): How do I store an HCT/P from a donor determined to be ineligible, and what uses of the HCT/P are not prohibited?
PART 1271-HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS · Subpart C-Donor Eligibility
Key facts
| Citation | 21 CFR 1271.65(c) |
|---|---|
| Section | How do I store an HCT/P from a donor determined to be ineligible, and what uses of the HCT/P are not prohibited? |
| 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 | Other_Regulations |
| Regulation text (excerpt) | (c) Nonclinical use. You may make available for nonclinical purposes an HCT/P from a donor who has been determined to be ineligible, based on the results of required testing and/or screening, provided that it is labeled: (1) “For Nonclinical Use Only” and (2) With the Biohazard legend shown in § 1271.3(h). |
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