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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 D - Drugs for Human Use |
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Part 436 - TESTS AND METHODS OF ASSAY OF ANTIBIOTIC AND ANTIBIOTIC-CONTAINING DRUGS |
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Subpart A - Definitions; Interpretations; Requirements |
| § 436.1 - Sterility requirements of items packaged with sterile antibiotic drugs. |
| § 436.2 - Alternative assay methods. |