CFR section
21 CFR 610.47(a)(1): Hepatitis C virus (HCV) “lookback” requirements
PART 610-GENERAL BIOLOGICAL PRODUCTS STANDARDS · Subpart E-Testing Requirements for Relevant Transfusion-Transmitted Infections
Key facts
| Citation | 21 CFR 610.47(a)(1) |
|---|---|
| Section | Hepatitis C virus (HCV) “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 |
| Regulation text (excerpt) | (1) Within 3 calendar days after a donor tests reactive for evidence of hepatitis C virus (HCV) infection when tested under § 610.40(a) and (b) of this chapter or when you are made aware of other reliable test results or information indicating evidence of HCV infection, you must review all records required under § 606.160(d) of this chapter, to identify blood and blood components previously donated by such a donor. For those identified blood and blood components collected: (i) Twelve months and… |
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