CFR section
21 CFR 610.46(a)(3): Human immunodeficiency virus (HIV) “lookback” requirements
PART 610-GENERAL BIOLOGICAL PRODUCTS STANDARDS · Subpart E-Testing Requirements for Relevant Transfusion-Transmitted Infections
Key facts
| Citation | 21 CFR 610.46(a)(3) |
|---|---|
| Section | Human immunodeficiency virus (HIV) “lookback” requirements |
| Part | PART 610-GENERAL BIOLOGICAL PRODUCTS STANDARDS |
| Subpart | Subpart E-Testing Requirements for Relevant Transfusion-Transmitted Infections |
| Subchapter | 21 CFR F Biologics |
| Product types cited | Biologics, Drugs |
| Regulation text (excerpt) | (3) You must notify consignees of the results of further testing for HIV, or the results of the reactive screening test if further testing under paragraph (a)(2) of this section is not available, or if under an investigational new drug application (IND) or investigational device exemption (IDE), is exempted for such use by FDA, within 45 calendar days after the donor tests reactive for evidence of HIV infection under § 610.40(a) and (b) of this chapter. Notification of consignees must include… |
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