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Code of Federal Regulations (Last Updated: May 6, 2024) |
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Title 21 - Food and Drugs |
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Chapter I - Food and Drug Administration, Department of Health and Human Services |
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SubChapter F - Biologics |
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Part 640 - Additional Standards for Human Blood and Blood Products |
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Subpart G - Source Plasma |
§ 640.60 - Source Plasma. |
§ 640.61 - Informed consent. |
§ 640.62 - Medical supervision. |
§ 640.63 - Suitability of donor. |
§ 640.64 - Collection of blood for Source Plasma. |
§ 640.65 - Plasmapheresis. |
§ 640.66 - Immunization of donors. |
§ 640.67 - Laboratory tests. |
§ 640.68 - Processing. |
§ 640.69 - General requirements. |
§ 640.70 - Labeling. |
§ 640.71 - Manufacturing responsibility. |
§ 640.72 - Records. |
§ 640.73 - Reporting of fatal donor reactions. |
§ 640.74 - Modification of Source Plasma. |
§ 640.76 - Products stored or shipped at unacceptable temperatures. |