CFR section
21 CFR 606.151(e): Compatibility testing
PART 606-CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND BLOOD COMPONENTS · Subpart H-Laboratory Controls
Key facts
| Citation | 21 CFR 606.151(e) |
|---|---|
| Section | Compatibility testing |
| Part | PART 606-CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND BLOOD COMPONENTS |
| Subpart | Subpart H-Laboratory Controls |
| Subchapter | 21 CFR F Biologics |
| Product types cited | Biologics, Drugs, Other_Regulations |
| Regulation text (excerpt) | (e) Procedures to expedite transfusion in life-threatening emergencies. Records of all such incidents shall be maintained, including complete documentation justifying the emergency action, which shall be signed by a physician. |
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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.