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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 A - General |
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Part 58 - Good Laboratory Practice for Nonclinical Laboratory Studies |
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Subpart F - Test and Control Articles |
§ 58.107 - Test and control article handling.
Latest version.
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§ 58.107 Test and control article handling.
Procedures shall be established for a system for the handling of the test and control articles to ensure that:
(a) There is proper storage.
(b) Distribution is made in a manner designed to preclude the possibility of contamination, deterioration, or damage.
(c) Proper identification is maintained throughout the distribution process.
(d) The receipt and distribution of each batch is documented. Such documentation shall include the date and quantity of each batch distributed or returned.