CFR section
21 CFR 610.40(a)(2): Test requirements
PART 610-GENERAL BIOLOGICAL PRODUCTS STANDARDS · Subpart E-Testing Requirements for Relevant Transfusion-Transmitted Infections
Key facts
| Citation | 21 CFR 610.40(a)(2) |
|---|---|
| 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 |
| Regulation text (excerpt) | (2) Test each donation for evidence of infection due to the relevant transfusion-transmitted infections described in § 630.3(h)(1)(iv) through (vii) of this chapter (HTLV, syphilis, West Nile virus, and Chagas disease). The following exceptions apply: (i) To identify evidence of infection with syphilis in donors of Source Plasma, you must test donors for evidence of such infection in accordance with § 640.65(b) of this chapter, and not under this section. (ii) You are not required to test… |
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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.