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- 21 CFR 610.40 · Test requirements.
- 21 CFR 610.41 · Donor deferral.
- 21 CFR 610.42 · Restrictions on use for further manufacture of medical devices.
- 21 CFR 610.44 · Use of reference panels by manufacturers of test kits.
- 21 CFR 610.46 · Human immunodeficiency virus (HIV) “lookback” requirements.
- 21 CFR 610.47 · Hepatitis C virus (HCV) “lookback” requirements.
- 21 CFR 610.48 · [Reserved]
- 21 CFR 610.50 · Date of manufacture for biological products.
- 21 CFR 610.53 · Dating periods for Whole Blood and blood components.
- 21 CFR 610.60 · Container label.
- 21 CFR 610.61 · Package label.
- 21 CFR 610.62 · Proper name; package label; legible type.
- 21 CFR 610.63 · Divided manufacturing responsibility to be shown.
- 21 CFR 610.64 · Name and address of distributor.
- 21 CFR 610.65 · Products for export.
- 21 CFR 610.67 · Bar code label requirements.
- 21 CFR 610.68 · Exceptions or alternatives to labeling requirements for biological products held by the Strategic National Stockpile.
- 21 CFR 630.1 · Purpose and scope.
- 21 CFR 630.3 · Definitions.
- 21 CFR 630.5 · Medical supervision.
- 21 CFR 630.10 · General donor eligibility requirements.
- 21 CFR 630.15 · Donor eligibility requirements specific to Whole Blood, Red Blood Cells and Plasma collected by apheresis.
- 21 CFR 630.20 · Exceptions for certain ineligible donors.
- 21 CFR 630.25 · Exceptions from certain donor eligibility requirements for infrequent plasma donors.
- 21 CFR 630.30 · Donation suitability requirements.
- 21 CFR 630.35 · Requalification of previously deferred donors.
- 21 CFR 630.40 · Requirements for notifying deferred donors.
- 21 CFR 640.1 · Whole Blood.
- 21 CFR 640.2 · General requirements.
- 21 CFR 640.4 · Collection of the blood.
- 21 CFR 640.5 · Testing the blood.
- 21 CFR 640.6 · Modifications of Whole Blood.
- 21 CFR 640.10 · Red Blood Cells.
- 21 CFR 640.11 · General requirements.
- 21 CFR 640.12 · Eligibility of donor.
- 21 CFR 640.13 · Collection of the blood.
- 21 CFR 640.14 · Testing the blood.
- 21 CFR 640.15 · Segments for testing.
- 21 CFR 640.16 · Processing.
- 21 CFR 640.17 · Modifications for specific products.
- 21 CFR 640.20 · Platelets.
- 21 CFR 640.21 · Eligibility of donors.
- 21 CFR 640.22 · Collection of source material.
- 21 CFR 640.23 · Testing the blood.
- 21 CFR 640.24 · Processing.
- 21 CFR 640.25 · General requirements.
- 21 CFR 640.30 · Plasma.
- 21 CFR 640.31 · Eligibility of donors.
- 21 CFR 640.32 · Collection of source material.
- 21 CFR 640.33 · Testing the blood.
- 21 CFR 640.34 · Processing.
- 21 CFR 640.50 · Cryoprecipitated AHF.
- 21 CFR 640.51 · Eligibility of donors.
- 21 CFR 640.52 · Collection of source material.
- 21 CFR 640.53 · Testing the blood.
- 21 CFR 640.54 · Processing.
- 21 CFR 640.55 · U.S. Standard preparation.
- 21 CFR 640.56 · Quality control test for potency.
- 21 CFR 640.60 · Source Plasma.
- 21 CFR 640.64 · Collection of blood for Source Plasma.
- 21 CFR 640.65 · Plasmapheresis.
- 21 CFR 640.66 · Immunization of donors.
- 21 CFR 640.67 · Laboratory tests.
- 21 CFR 640.68 · Processing.
- 21 CFR 640.69 · General requirements.
- 21 CFR 640.71 · Manufacturing responsibility.
- 21 CFR 640.72 · Records.
- 21 CFR 640.73 · Reporting of fatal donor reactions.
- 21 CFR 640.74 · Modification of Source Plasma.
- 21 CFR 640.76 · Products stored or shipped at unacceptable temperatures.
- 21 CFR 640.80 · Albumin (Human).
- 21 CFR 640.81 · Processing.
- 21 CFR 640.82 · Tests on final product.
- 21 CFR 640.83 · General requirements.
- 21 CFR 640.84 · Labeling.
- 21 CFR 640.90 · Plasma Protein Fraction (Human).
- 21 CFR 640.91 · Processing.
- 21 CFR 640.92 · Tests on final product.
- 21 CFR 640.93 · General requirements.
- 21 CFR 640.94 · Labeling.
- 21 CFR 640.100 · Immune Globulin (Human).
- 21 CFR 640.101 · General requirements.
- 21 CFR 640.102 · Manufacture of Immune Globulin (Human).
- 21 CFR 640.103 · The final product.
- 21 CFR 640.104 · Potency.
- 21 CFR 640.120 · Alternative procedures.
- 21 CFR 640.125 · Definitions.
- 21 CFR 640.130 · Medical supervision.
- 21 CFR 660.1 · Antibody to Hepatitis B Surface Antigen.
- 21 CFR 660.2 · General requirements.
- 21 CFR 660.3 · Reference panel.
- 21 CFR 660.4 · Potency test.
- 21 CFR 660.5 · Specificity.
- 21 CFR 660.6 · Samples; protocols; official release.
- 21 CFR 660.20 · Blood Grouping Reagent.
- 21 CFR 660.21 · Processing.
- 21 CFR 660.22 · Potency requirements with reference preparations.
- 21 CFR 660.25 · Potency tests without reference preparations.
- 21 CFR 660.26 · Specificity tests and avidity tests.
- 21 CFR 660.28 · Labeling.