CFR section
21 CFR 610.46(b)(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(b)(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) When further testing for HIV is positive or when the screening test is reactive and further testing is not available, or if under an IND or IDE is exempted for such use by FDA, you must notify transfusion recipients of previous collections of blood and blood components at increased risk of transmitting HIV infection, or the recipient's physician of record, of the need for recipient HIV testing and counseling. You must notify the recipient's physician of record or a legal representative or… |
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