| 21:7.0.1.1.1 | PART 600
| PART 600 - BIOLOGICAL PRODUCTS: GENERAL | |
| 21:7.0.1.1.1.1 | SUBPART A
| Subpart A - General Provisions | |
| 21:7.0.1.1.1.1.1.1 | SECTION 600.2
| 600.2 Mailing addresses. | |
| 21:7.0.1.1.1.1.1.2 | SECTION 600.3
| 600.3 Definitions. | |
| 21:7.0.1.1.1.2 | SUBPART B
| Subpart B - Establishment Standards | |
| 21:7.0.1.1.1.2.1.1 | SECTION 600.10
| 600.10 Personnel. | |
| 21:7.0.1.1.1.2.1.2 | SECTION 600.11
| 600.11 Physical establishment, equipment, animals, and care. | |
| 21:7.0.1.1.1.2.1.3 | SECTION 600.12
| 600.12 Records. | |
| 21:7.0.1.1.1.2.1.4 | SECTION 600.13
| 600.13 Retention samples. | |
| 21:7.0.1.1.1.2.1.5 | SECTION 600.14
| 600.14 Reporting of biological product deviations by licensed manufacturers. | |
| 21:7.0.1.1.1.2.1.6 | SECTION 600.15
| 600.15 Temperatures during shipment. | |
| 21:7.0.1.1.1.3 | SUBPART C
| Subpart C - Establishment Inspection | |
| 21:7.0.1.1.1.3.1.1 | SECTION 600.20
| 600.20 Inspectors. | |
| 21:7.0.1.1.1.3.1.2 | SECTION 600.21
| 600.21 Time of inspection. | |
| 21:7.0.1.1.1.3.1.3 | SECTION 600.22
| 600.22 [Reserved] | |
| 21:7.0.1.1.1.4 | SUBPART D
| Subpart D - Reporting of Adverse Experiences | |
| 21:7.0.1.1.1.4.1.1 | SECTION 600.80
| 600.80 Postmarketing reporting of adverse experiences. | |
| 21:7.0.1.1.1.4.1.2 | SECTION 600.81
| 600.81 Distribution reports. | |
| 21:7.0.1.1.1.4.1.3 | SECTION 600.82
| 600.82 Notification of a permanent discontinuance or an interruption in manufacturing. | |
| 21:7.0.1.1.1.4.1.4 | SECTION 600.90
| 600.90 Waivers. | |
| 21:7.0.1.1.2 | PART 601
| PART 601 - LICENSING | |
| 21:7.0.1.1.2.1 | SUBPART A
| Subpart A - General Provisions | |
| 21:7.0.1.1.2.1.1.1 | SECTION 601.2
| 601.2 Applications for biologics licenses; procedures for filing. | |
| 21:7.0.1.1.2.1.1.2 | SECTION 601.3
| 601.3 Complete response letter to the applicant. | |
| 21:7.0.1.1.2.1.1.3 | SECTION 601.4
| 601.4 Issuance and denial of license. | |
| 21:7.0.1.1.2.1.1.4 | SECTION 601.5
| 601.5 Revocation of license. | |
| 21:7.0.1.1.2.1.1.5 | SECTION 601.6
| 601.6 Suspension of license. | |
| 21:7.0.1.1.2.1.1.6 | SECTION 601.7
| 601.7 Procedure for hearings. | |
| 21:7.0.1.1.2.1.1.7 | SECTION 601.8
| 601.8 Publication of revocation. | |
| 21:7.0.1.1.2.1.1.8 | SECTION 601.9
| 601.9 Licenses; reissuance. | |
| 21:7.0.1.1.2.2 | SUBPART B
| Subpart B [Reserved] | |
| 21:7.0.1.1.2.3 | SUBPART C
| Subpart C - Biologics Licensing | |
| 21:7.0.1.1.2.3.1.1 | SECTION 601.12
| 601.12 Changes to an approved application. | |
| 21:7.0.1.1.2.3.1.2 | SECTION 601.14
| 601.14 Regulatory submissions in electronic format. | |
| 21:7.0.1.1.2.3.1.3 | SECTION 601.15
| 601.15 Foreign establishments and products: samples for each importation. | |
| 21:7.0.1.1.2.3.1.4 | SECTION 601.20
| 601.20 Biologics licenses; issuance and conditions. | |
| 21:7.0.1.1.2.3.1.5 | SECTION 601.21
| 601.21 Products under development. | |
| 21:7.0.1.1.2.3.1.6 | SECTION 601.22
| 601.22 Products in short supply; initial manufacturing at other than licensed location. | |
| 21:7.0.1.1.2.3.1.7 | SECTION 601.27
| 601.27 Pediatric studies. | |
| 21:7.0.1.1.2.3.1.8 | SECTION 601.28
| 601.28 Annual reports of postmarketing pediatric studies. | |
| 21:7.0.1.1.2.3.1.9 | SECTION 601.29
| 601.29 Guidance documents. | |
| 21:7.0.1.1.2.4 | SUBPART D
| Subpart D - Diagnostic Radiopharmaceuticals | |
| 21:7.0.1.1.2.4.1.1 | SECTION 601.30
| 601.30 Scope. | |
| 21:7.0.1.1.2.4.1.2 | SECTION 601.31
| 601.31 Definition. | |
| 21:7.0.1.1.2.4.1.3 | SECTION 601.32
| 601.32 General factors relevant to safety and effectiveness. | |
| 21:7.0.1.1.2.4.1.4 | SECTION 601.33
| 601.33 Indications. | |
| 21:7.0.1.1.2.4.1.5 | SECTION 601.34
| 601.34 Evaluation of effectiveness. | |
| 21:7.0.1.1.2.4.1.6 | SECTION 601.35
| 601.35 Evaluation of safety. | |
| 21:7.0.1.1.2.5 | SUBPART E
| Subpart E - Accelerated Approval of Biological Products for Serious or Life-Threatening Illnesses | |
| 21:7.0.1.1.2.5.1.1 | SECTION 601.40
| 601.40 Scope. | |
| 21:7.0.1.1.2.5.1.2 | SECTION 601.41
| 601.41 Approval based on a surrogate endpoint or on an effect on a clinical endpoint other than survival or irreversible morbidity. | |
| 21:7.0.1.1.2.5.1.3 | SECTION 601.42
| 601.42 Approval with restrictions to assure safe use. | |
| 21:7.0.1.1.2.5.1.4 | SECTION 601.43
| 601.43 Withdrawal procedures. | |
| 21:7.0.1.1.2.5.1.5 | SECTION 601.44
| 601.44 Postmarketing safety reporting. | |
| 21:7.0.1.1.2.5.1.6 | SECTION 601.45
| 601.45 Promotional materials. | |
| 21:7.0.1.1.2.5.1.7 | SECTION 601.46
| 601.46 Termination of requirements. | |
| 21:7.0.1.1.2.6 | SUBPART F
| Subpart F - Confidentiality of Information | |
| 21:7.0.1.1.2.6.1.1 | SECTION 601.50
| 601.50 Confidentiality of data and information in an investigational new drug notice for a biological product. | |
| 21:7.0.1.1.2.6.1.2 | SECTION 601.51
| 601.51 Confidentiality of data and information in applications for biologics licenses. | |
| 21:7.0.1.1.2.7 | SUBPART G
| Subpart G - Postmarketing Studies | |
| 21:7.0.1.1.2.7.1.1 | SECTION 601.70
| 601.70 Annual progress reports of postmarketing studies. | |
| 21:7.0.1.1.2.8 | SUBPART H
| Subpart H - Approval of Biological Products When Human Efficacy Studies Are Not Ethical or Feasible | |
| 21:7.0.1.1.2.8.1.1 | SECTION 601.90
| 601.90 Scope. | |
| 21:7.0.1.1.2.8.1.2 | SECTION 601.91
| 601.91 Approval based on evidence of effectiveness from studies in animals. | |
| 21:7.0.1.1.2.8.1.3 | SECTION 601.92
| 601.92 Withdrawal procedures. | |
| 21:7.0.1.1.2.8.1.4 | SECTION 601.93
| 601.93 Postmarketing safety reporting. | |
| 21:7.0.1.1.2.8.1.5 | SECTION 601.94
| 601.94 Promotional materials. | |
| 21:7.0.1.1.2.8.1.6 | SECTION 601.95
| 601.95 Termination of requirements. | |
| 21:7.0.1.1.3 | PART 606
| PART 606 - CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND BLOOD COMPONENTS | |
| 21:7.0.1.1.3.1 | SUBPART A
| Subpart A - General Provisions | |
| 21:7.0.1.1.3.1.1.1 | SECTION 606.3
| 606.3 Definitions. | |
| 21:7.0.1.1.3.2 | SUBPART B
| Subpart B - Organization and Personnel | |
| 21:7.0.1.1.3.2.1.1 | SECTION 606.20
| 606.20 Personnel. | |
| 21:7.0.1.1.3.3 | SUBPART C
| Subpart C - Plant and Facilities | |
| 21:7.0.1.1.3.3.1.1 | SECTION 606.40
| 606.40 Facilities. | |
| 21:7.0.1.1.3.4 | SUBPART D
| Subpart D - Equipment | |
| 21:7.0.1.1.3.4.1.1 | SECTION 606.60
| 606.60 Equipment. | |
| 21:7.0.1.1.3.4.1.2 | SECTION 606.65
| 606.65 Supplies and reagents. | |
| 21:7.0.1.1.3.5 | SUBPART E
| Subpart E [Reserved] | |
| 21:7.0.1.1.3.6 | SUBPART F
| Subpart F - Production and Process Controls | |
| 21:7.0.1.1.3.6.1.1 | SECTION 606.100
| 606.100 Standard operating procedures. | |
| 21:7.0.1.1.3.6.1.2 | SECTION 606.110
| 606.110 Plateletpheresis, leukapheresis, and plasmapheresis. | |
| 21:7.0.1.1.3.7 | SUBPART G
| Subpart G - Additional Labeling Standards for Blood and Blood Components | |
| 21:7.0.1.1.3.7.1.1 | SECTION 606.120
| 606.120 Labeling, general requirements. | |
| 21:7.0.1.1.3.7.1.2 | SECTION 606.121
| 606.121 Container label. | |
| 21:7.0.1.1.3.7.1.3 | SECTION 606.122
| 606.122 Circular of information. | |
| 21:7.0.1.1.3.8 | SUBPART H
| Subpart H - Laboratory Controls | |
| 21:7.0.1.1.3.8.1.1 | SECTION 606.140
| 606.140 Laboratory controls. | |
| 21:7.0.1.1.3.8.1.2 | SECTION 606.145
| 606.145 Control of bacterial contamination of platelets. | |
| 21:7.0.1.1.3.8.1.3 | SECTION 606.151
| 606.151 Compatibility testing. | |
| 21:7.0.1.1.3.9 | SUBPART I
| Subpart I - Records and Reports | |
| 21:7.0.1.1.3.9.1.1 | SECTION 606.160
| 606.160 Records. | |
| 21:7.0.1.1.3.9.1.2 | SECTION 606.165
| 606.165 Distribution and receipt; procedures and records. | |
| 21:7.0.1.1.3.9.1.3 | SECTION 606.170
| 606.170 Adverse reaction file. | |
| 21:7.0.1.1.3.9.1.4 | SECTION 606.171
| 606.171 Reporting of product deviations by licensed manufacturers, unlicensed registered blood establishments, and transfusion services. | |
| 21:7.0.1.1.4 | PART 607
| PART 607 - ESTABLISHMENT REGISTRATION AND PRODUCT LISTING FOR MANUFACTURERS OF HUMAN BLOOD AND BLOOD PRODUCTS AND LICENSED DEVICES | |
| 21:7.0.1.1.4.1 | SUBPART A
| Subpart A - General Provisions | |
| 21:7.0.1.1.4.1.1.1 | SECTION 607.1
| 607.1 Scope. | |
| 21:7.0.1.1.4.1.1.2 | SECTION 607.3
| 607.3 Definitions. | |
| 21:7.0.1.1.4.1.1.3 | SECTION 607.7
| 607.7 Establishment registration and product listing of blood banks and other firms manufacturing human blood and blood products. | |
| 21:7.0.1.1.4.2 | SUBPART B
| Subpart B - Procedures for Domestic Blood Product Establishments | |
| 21:7.0.1.1.4.2.1.1 | SECTION 607.20
| 607.20 Who must register and submit a blood product list. | |
| 21:7.0.1.1.4.2.1.2 | SECTION 607.21
| 607.21 Times for establishment registration and blood product listing. | |
| 21:7.0.1.1.4.2.1.3 | SECTION 607.22
| 607.22 How to register establishments and list blood products. | |
| 21:7.0.1.1.4.2.1.4 | SECTION 607.25
| 607.25 Information required for establishment registration and blood product listing. | |
| 21:7.0.1.1.4.2.1.5 | SECTION 607.26
| 607.26 Amendments to establishment registration. | |
| 21:7.0.1.1.4.2.1.6 | SECTION 607.30
| 607.30 Updating blood product listing information. | |
| 21:7.0.1.1.4.2.1.7 | SECTION 607.31
| 607.31 Additional blood product listing information. | |
| 21:7.0.1.1.4.2.1.8 | SECTION 607.35
| 607.35 Blood product establishment registration number. | |
| 21:7.0.1.1.4.2.1.9 | SECTION 607.37
| 607.37 Public disclosure of establishment registration and blood product listing information. | |
| 21:7.0.1.1.4.2.1.10 | SECTION 607.39
| 607.39 Misbranding by reference to establishment registration, validation of registration, or to registration number. | |
| 21:7.0.1.1.4.3 | SUBPART C
| Subpart C - Procedures for Foreign Blood Product Establishments | |
| 21:7.0.1.1.4.3.1.1 | SECTION 607.40
| 607.40 Establishment registration and blood product listing requirements for foreign blood product establishments. | |
| 21:7.0.1.1.4.4 | SUBPART D
| Subpart D - Exemptions | |
| 21:7.0.1.1.4.4.1.1 | SECTION 607.65
| 607.65 Exemptions for blood product establishments. | |
| 21:7.0.1.1.4.5 | SUBPART E
| Subpart E - Establishment Registration and Product Listing Of Licensed Devices | |
| 21:7.0.1.1.4.5.1.1 | SECTION 607.80
| 607.80 Applicability of part 607 to licensed devices. | |
| 21:7.0.1.1.5 | PART 610
| PART 610 - GENERAL BIOLOGICAL PRODUCTS STANDARDS | |
| 21:7.0.1.1.5.1 | SUBPART A
| Subpart A - Release Requirements | |
| 21:7.0.1.1.5.1.1.1 | SECTION 610.1
| 610.1 Tests prior to release required for each lot. | |
| 21:7.0.1.1.5.1.1.2 | SECTION 610.2
| 610.2 Requests for samples and protocols; official release. | |
| 21:7.0.1.1.5.2 | SUBPART B
| Subpart B - General Provisions | |
| 21:7.0.1.1.5.2.1.1 | SECTION 610.9
| 610.9 Equivalent methods and processes. | |
| 21:7.0.1.1.5.2.1.2 | SECTION 610.10
| 610.10 Potency. | |
| 21:7.0.1.1.5.2.1.3 | SECTION 610.11-610.11a
| 610.11-610.11a [Reserved] | |
| 21:7.0.1.1.5.2.1.4 | SECTION 610.12
| 610.12 Sterility. | |
| 21:7.0.1.1.5.2.1.5 | SECTION 610.13
| 610.13 Purity. | |
| 21:7.0.1.1.5.2.1.6 | SECTION 610.14
| 610.14 Identity. | |
| 21:7.0.1.1.5.2.1.7 | SECTION 610.15
| 610.15 Constituent materials. | |
| 21:7.0.1.1.5.2.1.8 | SECTION 610.16
| 610.16 Total solids in serums. | |
| 21:7.0.1.1.5.2.1.9 | SECTION 610.17
| 610.17 Permissible combinations. | |
| 21:7.0.1.1.5.2.1.10 | SECTION 610.18
| 610.18 Cultures. | |
| 21:7.0.1.1.5.3 | SUBPART C
| Subpart C [Reserved] | |
| 21:7.0.1.1.5.4 | SUBPART D
| Subpart D [Reserved] | |
| 21:7.0.1.1.5.4.1.1 | SECTION 610.20-610.21
| 610.20-610.21 [Reserved] | |
| 21:7.0.1.1.5.5 | SUBPART E
| Subpart E - Testing Requirements for Relevant Transfusion-Transmitted Infections | |
| 21:7.0.1.1.5.5.1.1 | SECTION 610.39
| 610.39 Definitions. | |
| 21:7.0.1.1.5.5.1.2 | SECTION 610.40
| 610.40 Test requirements. | |
| 21:7.0.1.1.5.5.1.3 | SECTION 610.41
| 610.41 Donor deferral. | |
| 21:7.0.1.1.5.5.1.4 | SECTION 610.42
| 610.42 Restrictions on use for further manufacture of medical devices. | |
| 21:7.0.1.1.5.5.1.5 | SECTION 610.44
| 610.44 Use of reference panels by manufacturers of test kits. | |
| 21:7.0.1.1.5.5.1.6 | SECTION 610.46
| 610.46 Human immunodeficiency virus (HIV) “lookback” requirements. | |
| 21:7.0.1.1.5.5.1.7 | SECTION 610.47
| 610.47 Hepatitis C virus (HCV) “lookback” requirements. | |
| 21:7.0.1.1.5.5.1.8 | SECTION 610.48
| 610.48 [Reserved] | |
| 21:7.0.1.1.5.6 | SUBPART F
| Subpart F - Dating Period Limitations | |
| 21:7.0.1.1.5.6.1.1 | SECTION 610.50
| 610.50 Date of manufacture for biological products. | |
| 21:7.0.1.1.5.6.1.2 | SECTION 610.53
| 610.53 Dating periods for Whole Blood and blood components. | |
| 21:7.0.1.1.5.7 | SUBPART G
| Subpart G - Labeling Standards | |
| 21:7.0.1.1.5.7.1.1 | SECTION 610.60
| 610.60 Container label. | |
| 21:7.0.1.1.5.7.1.2 | SECTION 610.61
| 610.61 Package label. | |
| 21:7.0.1.1.5.7.1.3 | SECTION 610.62
| 610.62 Proper name; package label; legible type. | |
| 21:7.0.1.1.5.7.1.4 | SECTION 610.63
| 610.63 Divided manufacturing responsibility to be shown. | |
| 21:7.0.1.1.5.7.1.5 | SECTION 610.64
| 610.64 Name and address of distributor. | |
| 21:7.0.1.1.5.7.1.6 | SECTION 610.65
| 610.65 Products for export. | |
| 21:7.0.1.1.5.7.1.7 | SECTION 610.67
| 610.67 Bar code label requirements. | |
| 21:7.0.1.1.5.7.1.8 | SECTION 610.68
| 610.68 Exceptions or alternatives to labeling requirements for biological products held by the Strategic National Stockpile. | |
| 21:7.0.1.1.6 | PART 630
| PART 630 - REQUIREMENTS FOR BLOOD AND BLOOD COMPONENTS INTENDED FOR TRANSFUSION OR FOR FURTHER MANUFACTURING USE | |
| 21:7.0.1.1.6.1 | SUBPART A
| Subpart A - General Provisions | |
| 21:7.0.1.1.6.1.1.1 | SECTION 630.1
| 630.1 Purpose and scope. | |
| 21:7.0.1.1.6.1.1.2 | SECTION 630.3
| 630.3 Definitions. | |
| 21:7.0.1.1.6.2 | SUBPART B
| Subpart B - Donor Eligibility Requirements | |
| 21:7.0.1.1.6.2.1.1 | SECTION 630.5
| 630.5 Medical supervision. | |
| 21:7.0.1.1.6.2.1.2 | SECTION 630.10
| 630.10 General donor eligibility requirements. | |
| 21:7.0.1.1.6.2.1.3 | SECTION 630.15
| 630.15 Donor eligibility requirements specific to Whole Blood, Red Blood Cells and Plasma collected by apheresis. | |
| 21:7.0.1.1.6.2.1.4 | SECTION 630.20
| 630.20 Exceptions for certain ineligible donors. | |
| 21:7.0.1.1.6.2.1.5 | SECTION 630.25
| 630.25 Exceptions from certain donor eligibility requirements for infrequent plasma donors. | |
| 21:7.0.1.1.6.2.1.6 | SECTION 630.30
| 630.30 Donation suitability requirements. | |
| 21:7.0.1.1.6.2.1.7 | SECTION 630.35
| 630.35 Requalification of previously deferred donors. | |
| 21:7.0.1.1.6.3 | SUBPART C
| Subpart C - Donor Notification | |
| 21:7.0.1.1.6.3.1.1 | SECTION 630.40
| 630.40 Requirements for notifying deferred donors. | |
| 21:7.0.1.1.7 | PART 640
| PART 640 - ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS | |
| 21:7.0.1.1.7.1 | SUBPART A
| Subpart A - Whole Blood | |
| 21:7.0.1.1.7.1.1.1 | SECTION 640.1
| 640.1 Whole Blood. | |
| 21:7.0.1.1.7.1.1.2 | SECTION 640.2
| 640.2 General requirements. | |
| 21:7.0.1.1.7.1.1.3 | SECTION 640.4
| 640.4 Collection of the blood. | |
| 21:7.0.1.1.7.1.1.4 | SECTION 640.5
| 640.5 Testing the blood. | |
| 21:7.0.1.1.7.1.1.5 | SECTION 640.6
| 640.6 Modifications of Whole Blood. | |
| 21:7.0.1.1.7.2 | SUBPART B
| Subpart B - Red Blood Cells | |
| 21:7.0.1.1.7.2.1.1 | SECTION 640.10
| 640.10 Red Blood Cells. | |
| 21:7.0.1.1.7.2.1.2 | SECTION 640.11
| 640.11 General requirements. | |
| 21:7.0.1.1.7.2.1.3 | SECTION 640.12
| 640.12 Eligibility of donor. | |
| 21:7.0.1.1.7.2.1.4 | SECTION 640.13
| 640.13 Collection of the blood. | |
| 21:7.0.1.1.7.2.1.5 | SECTION 640.14
| 640.14 Testing the blood. | |
| 21:7.0.1.1.7.2.1.6 | SECTION 640.15
| 640.15 Segments for testing. | |
| 21:7.0.1.1.7.2.1.7 | SECTION 640.16
| 640.16 Processing. | |
| 21:7.0.1.1.7.2.1.8 | SECTION 640.17
| 640.17 Modifications for specific products. | |
| 21:7.0.1.1.7.3 | SUBPART C
| Subpart C - Platelets | |
| 21:7.0.1.1.7.3.1.1 | SECTION 640.20
| 640.20 Platelets. | |
| 21:7.0.1.1.7.3.1.2 | SECTION 640.21
| 640.21 Eligibility of donors. | |
| 21:7.0.1.1.7.3.1.3 | SECTION 640.22
| 640.22 Collection of source material. | |
| 21:7.0.1.1.7.3.1.4 | SECTION 640.23
| 640.23 Testing the blood. | |
| 21:7.0.1.1.7.3.1.5 | SECTION 640.24
| 640.24 Processing. | |
| 21:7.0.1.1.7.3.1.6 | SECTION 640.25
| 640.25 General requirements. | |
| 21:7.0.1.1.7.4 | SUBPART D
| Subpart D - Plasma | |
| 21:7.0.1.1.7.4.1.1 | SECTION 640.30
| 640.30 Plasma. | |
| 21:7.0.1.1.7.4.1.2 | SECTION 640.31
| 640.31 Eligibility of donors. | |
| 21:7.0.1.1.7.4.1.3 | SECTION 640.32
| 640.32 Collection of source material. | |
| 21:7.0.1.1.7.4.1.4 | SECTION 640.33
| 640.33 Testing the blood. | |
| 21:7.0.1.1.7.4.1.5 | SECTION 640.34
| 640.34 Processing. | |
| 21:7.0.1.1.7.5 | SUBPART E
| Subpart E [Reserved] | |
| 21:7.0.1.1.7.6 | SUBPART F
| Subpart F - Cryoprecipitate | |
| 21:7.0.1.1.7.6.1.1 | SECTION 640.50
| 640.50 Cryoprecipitated AHF. | |
| 21:7.0.1.1.7.6.1.2 | SECTION 640.51
| 640.51 Eligibility of donors. | |
| 21:7.0.1.1.7.6.1.3 | SECTION 640.52
| 640.52 Collection of source material. | |
| 21:7.0.1.1.7.6.1.4 | SECTION 640.53
| 640.53 Testing the blood. | |
| 21:7.0.1.1.7.6.1.5 | SECTION 640.54
| 640.54 Processing. | |
| 21:7.0.1.1.7.6.1.6 | SECTION 640.55
| 640.55 U.S. Standard preparation. | |
| 21:7.0.1.1.7.6.1.7 | SECTION 640.56
| 640.56 Quality control test for potency. | |
| 21:7.0.1.1.7.7 | SUBPART G
| Subpart G - Source Plasma | |
| 21:7.0.1.1.7.7.1.1 | SECTION 640.60
| 640.60 Source Plasma. | |
| 21:7.0.1.1.7.7.1.2 | SECTION 640.64
| 640.64 Collection of blood for Source Plasma. | |
| 21:7.0.1.1.7.7.1.3 | SECTION 640.65
| 640.65 Plasmapheresis. | |
| 21:7.0.1.1.7.7.1.4 | SECTION 640.66
| 640.66 Immunization of donors. | |
| 21:7.0.1.1.7.7.1.5 | SECTION 640.67
| 640.67 Laboratory tests. | |
| 21:7.0.1.1.7.7.1.6 | SECTION 640.68
| 640.68 Processing. | |
| 21:7.0.1.1.7.7.1.7 | SECTION 640.69
| 640.69 General requirements. | |
| 21:7.0.1.1.7.7.1.8 | SECTION 640.71
| 640.71 Manufacturing responsibility. | |
| 21:7.0.1.1.7.7.1.9 | SECTION 640.72
| 640.72 Records. | |
| 21:7.0.1.1.7.7.1.10 | SECTION 640.73
| 640.73 Reporting of fatal donor reactions. | |
| 21:7.0.1.1.7.7.1.11 | SECTION 640.74
| 640.74 Modification of Source Plasma. | |
| 21:7.0.1.1.7.7.1.12 | SECTION 640.76
| 640.76 Products stored or shipped at unacceptable temperatures. | |
| 21:7.0.1.1.7.8 | SUBPART H
| Subpart H - Albumin (Human) | |
| 21:7.0.1.1.7.8.1.1 | SECTION 640.80
| 640.80 Albumin (Human). | |
| 21:7.0.1.1.7.8.1.2 | SECTION 640.81
| 640.81 Processing. | |
| 21:7.0.1.1.7.8.1.3 | SECTION 640.82
| 640.82 Tests on final product. | |
| 21:7.0.1.1.7.8.1.4 | SECTION 640.83
| 640.83 General requirements. | |
| 21:7.0.1.1.7.8.1.5 | SECTION 640.84
| 640.84 Labeling. | |
| 21:7.0.1.1.7.9 | SUBPART I
| Subpart I - Plasma Protein Fraction (Human) | |
| 21:7.0.1.1.7.9.1.1 | SECTION 640.90
| 640.90 Plasma Protein Fraction (Human). | |
| 21:7.0.1.1.7.9.1.2 | SECTION 640.91
| 640.91 Processing. | |
| 21:7.0.1.1.7.9.1.3 | SECTION 640.92
| 640.92 Tests on final product. | |
| 21:7.0.1.1.7.9.1.4 | SECTION 640.93
| 640.93 General requirements. | |
| 21:7.0.1.1.7.9.1.5 | SECTION 640.94
| 640.94 Labeling. | |
| 21:7.0.1.1.7.10 | SUBPART J
| Subpart J - Immune Globulin (Human) | |
| 21:7.0.1.1.7.10.1.1 | SECTION 640.100
| 640.100 Immune Globulin (Human). | |
| 21:7.0.1.1.7.10.1.2 | SECTION 640.101
| 640.101 General requirements. | |
| 21:7.0.1.1.7.10.1.3 | SECTION 640.102
| 640.102 Manufacture of Immune Globulin (Human). | |
| 21:7.0.1.1.7.10.1.4 | SECTION 640.103
| 640.103 The final product. | |
| 21:7.0.1.1.7.10.1.5 | SECTION 640.104
| 640.104 Potency. | |
| 21:7.0.1.1.7.11 | SUBPART K
| Subpart K [Reserved] | |
| 21:7.0.1.1.7.12 | SUBPART L
| Subpart L - Alternative Procedures | |
| 21:7.0.1.1.7.12.1.1 | SECTION 640.120
| 640.120 Alternative procedures. | |
| 21:7.0.1.1.7.13 | SUBPART M
| Subpart M - Definitions and Medical Supervision | |
| 21:7.0.1.1.7.13.1.1 | SECTION 640.125
| 640.125 Definitions. | |
| 21:7.0.1.1.7.13.1.2 | SECTION 640.130
| 640.130 Medical supervision. | |
| 21:7.0.1.1.8 | PART 660
| PART 660 - ADDITIONAL STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS | |
| 21:7.0.1.1.8.1 | SUBPART A
| Subpart A - Antibody to Hepatitis B Surface Antigen | |
| 21:7.0.1.1.8.1.1.1 | SECTION 660.1
| 660.1 Antibody to Hepatitis B Surface Antigen. | |
| 21:7.0.1.1.8.1.1.2 | SECTION 660.2
| 660.2 General requirements. | |
| 21:7.0.1.1.8.1.1.3 | SECTION 660.3
| 660.3 Reference panel. | |
| 21:7.0.1.1.8.1.1.4 | SECTION 660.4
| 660.4 Potency test. | |
| 21:7.0.1.1.8.1.1.5 | SECTION 660.5
| 660.5 Specificity. | |
| 21:7.0.1.1.8.1.1.6 | SECTION 660.6
| 660.6 Samples; protocols; official release. | |
| 21:7.0.1.1.8.2 | SUBPART B
| Subpart B [Reserved] | |
| 21:7.0.1.1.8.3 | SUBPART C
| Subpart C - Blood Grouping Reagent | |
| 21:7.0.1.1.8.3.1.1 | SECTION 660.20
| 660.20 Blood Grouping Reagent. | |
| 21:7.0.1.1.8.3.1.2 | SECTION 660.21
| 660.21 Processing. | |
| 21:7.0.1.1.8.3.1.3 | SECTION 660.22
| 660.22 Potency requirements with reference preparations. | |
| 21:7.0.1.1.8.3.1.4 | SECTION 660.25
| 660.25 Potency tests without reference preparations. | |
| 21:7.0.1.1.8.3.1.5 | SECTION 660.26
| 660.26 Specificity tests and avidity tests. | |
| 21:7.0.1.1.8.3.1.6 | SECTION 660.28
| 660.28 Labeling. | |
| 21:7.0.1.1.8.4 | SUBPART D
| Subpart D - Reagent Red Blood Cells | |
| 21:7.0.1.1.8.4.1.1 | SECTION 660.30
| 660.30 Reagent Red Blood Cells. | |
| 21:7.0.1.1.8.4.1.2 | SECTION 660.31
| 660.31 Eligibility of donor. | |
| 21:7.0.1.1.8.4.1.3 | SECTION 660.32
| 660.32 Collection of source material. | |
| 21:7.0.1.1.8.4.1.4 | SECTION 660.33
| 660.33 Testing of source material. | |
| 21:7.0.1.1.8.4.1.5 | SECTION 660.34
| 660.34 Processing. | |
| 21:7.0.1.1.8.4.1.6 | SECTION 660.35
| 660.35 Labeling. | |
| 21:7.0.1.1.8.4.1.7 | SECTION 660.36
| 660.36 Samples and protocols. | |
| 21:7.0.1.1.8.5 | SUBPART E
| Subpart E - Hepatitis B Surface Antigen | |
| 21:7.0.1.1.8.5.1.1 | SECTION 660.40
| 660.40 Hepatitis B Surface Antigen. | |
| 21:7.0.1.1.8.5.1.2 | SECTION 660.41
| 660.41 Processing. | |
| 21:7.0.1.1.8.5.1.3 | SECTION 660.43
| 660.43 Potency test. | |
| 21:7.0.1.1.8.5.1.4 | SECTION 660.44
| 660.44 Specificity. | |
| 21:7.0.1.1.8.5.1.5 | SECTION 660.45
| 660.45 Labeling. | |
| 21:7.0.1.1.8.5.1.6 | SECTION 660.46
| 660.46 Samples; protocols; official release. | |
| 21:7.0.1.1.8.6 | SUBPART F
| Subpart F - Anti-Human Globulin | |
| 21:7.0.1.1.8.6.1.1 | SECTION 660.50
| 660.50 Anti-Human Globulin. | |
| 21:7.0.1.1.8.6.1.2 | SECTION 660.51
| 660.51 Processing. | |
| 21:7.0.1.1.8.6.1.3 | SECTION 660.52
| 660.52 Reference preparations. | |
| 21:7.0.1.1.8.6.1.4 | SECTION 660.53
| 660.53 Controls for serological procedures. | |
| 21:7.0.1.1.8.6.1.5 | SECTION 660.54
| 660.54 Potency tests, specificity tests, tests for heterospecific antibodies, and additional tests for nonspecific properties. | |
| 21:7.0.1.1.8.6.1.6 | SECTION 660.55
| 660.55 Labeling. | |
| 21:7.0.1.1.9 | PART 680
| PART 680 - ADDITIONAL STANDARDS FOR MISCELLANEOUS PRODUCTS | |
| 21:7.0.1.1.9.0.1.1 | SECTION 680.1
| 680.1 Allergenic Products. | |
| 21:7.0.1.1.9.0.1.2 | SECTION 680.2
| 680.2 Manufacture of Allergenic Products. | |
| 21:7.0.1.1.9.0.1.3 | SECTION 680.3
| 680.3 Tests. | |