|
|
|
Title 21--Food and Drugs
CHAPTER I--FOOD AND DRUG ADMINISTRATION,
DEPARTMENT OF HEALTH AND HUMAN SERVICES--
PART 640--ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS
|
|||
 |
 | 640.1 | Whole Blood. |
|
|
| 640.2 | General requirements. |
|
|
| 640.3 | Suitability of donor. |
|
|
| 640.4 | Collection of the blood. |
|
|
| 640.5 | Testing the blood. |
|
|
| 640.6 | Modifications of Whole Blood. |
|
|
| 640.10 | Red Blood Cells. |
|
|
| 640.11 | General requirements. |
|
|
| 640.12 | Suitability of donor. |
|
|
| 640.13 | Collection of the blood. |
|
|
| 640.14 | Testing the blood. |
|
|
| 640.15 | Samples for testing. |
|
|
| 640.16 | Processing. |
|
|
| 640.17 | Modifications for specific products. |
|
|
| 640.20 | Platelets. |
|
|
| 640.21 | Suitability of donors. |
|
|
| 640.22 | Collection of source material. |
|
|
| 640.23 | Testing the blood. |
|
|
| 640.24 | Processing. |
|
|
| 640.25 | General requirements. |
|
|
| 640.27 | Emergency provisions. |
|
|
| 640.30 | Plasma. |
|
|
| 640.31 | Suitability of donors. |
|
|
| 640.32 | Collection of source material. |
|
|
| 640.33 | Testing the blood. |
|
|
| 640.34 | Processing. |
|
|
| 640.50 | Cryoprecipitated AHF. |
|
|
| 640.51 | Suitability of donors. |
|
|
| 640.52 | Collection of source material. |
|
|
| 640.53 | Testing the blood. |
|
|
| 640.54 | Processing. |
|
|
| 640.55 | U.S. Standard preparation. |
|
|
| 640.56 | Quality control test for potency. |
|
|
| 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. |
|
|
| 640.80 | Albumin (Human). |
|
|
| 640.81 | Processing. |
|
|
| 640.82 | Tests on final product. |
|
|
| 640.83 | General requirements. |
|
|
| 640.84 | Labeling. |
|
|
| 640.90 | Plasma Protein Fraction (Human). |
|
|
| 640.91 | Processing. |
|
|
| 640.92 | Tests on final product. |
|
|
| 640.93 | General requirements. |
|
|
| 640.94 | Labeling. |
|
|
| 640.100 | Immune Globulin (Human). |
|
|
| 640.101 | General requirements. |
|
|
| 640.102 | Manufacture of Immune Globulin (Human). |
|
|
| 640.103 | The final product. |
|
|
| 640.104 | Potency. |
|
|
| 640.120 | Alternative procedures. |
![[BACK ]](http://www.access.gpo.gov/su_docs/images/icons/lefticn2.gif){kind=icon}
![[BACK ]](http://www.access.gpo.gov/su_docs/images/icons/content.gif){kind=icon}