CFR section
21 CFR 610.40(d)(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(d)(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) If you ship autologous donations to another establishment that allows autologous donations to be used for allogeneic transfusion, you must assure that all autologous donations shipped to that establishment are tested under this section. |
At a glance
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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.