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Title 21 - Title 21

Part 58 - GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES

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Description

GENERAL - GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES

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36 sections

§58.1 - Scope.

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§58.10 - Applicability to studies performed under grants and contracts.

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§58.105 - Test and control article characterization.

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§58.107 - Test and control article handling.

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§58.113 - Mixtures of articles with carriers.

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§58.120 - Protocol.

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§58.130 - Conduct of a nonclinical laboratory study.

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§58.15 - Inspection of a testing facility.

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§58.185 - Reporting of nonclinical laboratory study results.

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§58.190 - Storage and retrieval of records and data.

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§58.195 - Retention of records.

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§58.200 - Purpose.

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§58.202 - Grounds for disqualification.

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§58.204 - Notice of and opportunity for hearing on proposed disqualification.

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§58.206 - Final order on disqualification.

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§58.210 - Actions upon disqualification.

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§58.213 - Public disclosure of information regarding disqualification.

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§58.215 - Alternative or additional actions to disqualification.

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§58.217 - Suspension or termination of a testing facility by a sponsor.

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§58.219 - Reinstatement of a disqualified testing facility.

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§58.29 - Personnel.

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§58.3 - Definitions.

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§58.31 - Testing facility management.

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§58.33 - Study director.

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§58.35 - Quality assurance unit.

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§58.41 - General.

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§58.43 - Animal care facilities.

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§58.45 - Animal supply facilities.

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§58.47 - Facilities for handling test and control articles.

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§58.49 - Laboratory operation areas.

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§58.51 - Specimen and data storage facilities.

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§58.61 - Equipment design.

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§58.63 - Maintenance and calibration of equipment.

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§58.81 - Standard operating procedures.

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§58.83 - Reagents and solutions.

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§58.90 - Animal care.

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