CFR section
21 CFR 610.40(d)(4): Test requirements
PART 610-GENERAL BIOLOGICAL PRODUCTS STANDARDS · Subpart E-Testing Requirements for Relevant Transfusion-Transmitted Infections
Key facts
| Citation | 21 CFR 610.40(d)(4) |
|---|---|
| Section | Test 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) | (4) Each autologous donation must be labeled as required under § 606.121 of this chapter and with the following label, as appropriate: Donor Testing Status Label Untested “DONOR UNTESTED” Tests negative Label as required under § 606.121 Reactive on current collection/reactive in the last 30 days “BIOHAZARD” legend in § 610.40(h)(2)(ii)(B) Tested negative within the last 30 days “DONOR TESTED WITHIN THE LAST 30 DAYS” |
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About CFR sections cited by the FDA
Title 21 of the Code of Federal Regulations contains the FDA's regulations, including current good manufacturing practice and quality system requirements that inspections cite.