CFR section
21 CFR 630.40(d)(1): Requirements for notifying deferred donors
PART 630-REQUIREMENTS FOR BLOOD AND BLOOD COMPONENTS INTENDED FOR TRANSFUSION OR FOR FURTHER MANUFACTURING USE · Subpart C-Donor Notification
Key facts
| Citation | 21 CFR 630.40(d)(1) |
|---|---|
| Section | Requirements for notifying deferred donors |
| Part | PART 630-REQUIREMENTS FOR BLOOD AND BLOOD COMPONENTS INTENDED FOR TRANSFUSION OR FOR FURTHER MANUFACTURING USE |
| Subpart | Subpart C-Donor Notification |
| Subchapter | 21 CFR F Biologics |
| Product types cited | Biologics, Devices, Drugs, General, Other_Regulations |
| Regulation text (excerpt) | (1) You also must provide the following information to the referring physician of an autologous donor who is deferred based on the results of tests for evidence of infection with a relevant transfusion-transmitted infection(s) or whose platelets indicate evidence of a bacterial infection that is endogenous to the bloodstream of the donor as described in paragraph (a) of this section: (i) Information that the autologous donor is deferred based on the results of tests for evidence of infection due… |
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