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Code of Federal Regulations (Last Updated: November 8, 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 610 - General Biological Products Standards |
| §§ 610.20--610.21 - [Reserved] |
| 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 - General safety. |
| § 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. |
| § 610.19 - Status of specific products; Group A streptococcus. |
| §§ 610.11--610.11a - [Reserved] |
| § 610.11a - Inactivated influenza vaccine, general safety test. |
| Subpart C - XXX |
| § 610.20 - Standard preparations. |
| § 610.21 - Limits of potency. |
| Subparts C--D - XXX |
| Subpart D - Mycoplasma |
| § 610.30 - Test for Mycoplasma. |
| 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. |
| § 610.45 - Human Immunodeficiency Virus (HIV) requirements. |
| § 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. |