21 CFR Part 610
PART 610—GENERAL BIOLOGICAL PRODUCTS STANDARDS
- PART 610—GENERAL BIOLOGICAL PRODUCTS STANDARDS
- Chapter I—Food and Drug Administration, Department of Health and Human Services › Subchapter F—Biologics
- Subpart A—Release Requirements
- § 610.1 Tests prior to release required for each lot.
- § 610.2 Requests for samples and protocols; official release.
- Subpart B—General Provisions
- § 610.9 Equivalent methods and processes.
- § 610.10 Potency.
- § 610.11-610.11a [Reserved]
- § 610.12 Sterility.
- § 610.13 Purity.
- § 610.14 Identity.
- § 610.15 Constituent materials.
- § 610.16 Total solids in serums.
- § 610.17 Permissible combinations.
- § 610.18 Cultures.
- Subparts C—D [Reserved]
- Subpart E—Testing Requirements for Relevant Transfusion-Transmitted Infections
- § 610.39 Definitions.
- § 610.40 Test requirements.
- § 610.41 Donor deferral.
- § 610.42 Restrictions on use for further manufacture of medical devices.
- § 610.44 Use of reference panels by manufacturers of test kits.
- § 610.46 Human immunodeficiency virus (HIV) “lookback” requirements.
- § 610.47 Hepatitis C virus (HCV) “lookback” requirements.
- § 610.48 [Reserved]
- Subpart F—Dating Period Limitations
- § 610.50 Date of manufacture for biological products.
- § 610.53 Dating periods for Whole Blood and blood components.
- Subpart G—Labeling Standards
- § 610.60 Container label.
- § 610.61 Package label.
- § 610.62 Proper name; package label; legible type.
- § 610.63 Divided manufacturing responsibility to be shown.
- § 610.64 Name and address of distributor.
- § 610.65 Products for export.
- § 610.67 Bar code label requirements.
- § 610.68 Exceptions or alternatives to labeling requirements for biological products held by the Strategic National Stockpile.
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