21 C.F.R. PART 58--GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES
TITLE 21--Food and Drugs
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER A--GENERAL
PART 58--GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES
Subpart A--GENERAL PROVISIONS
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| Applicability to studies performed under grants and contracts.
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| Inspection of a testing facility.
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Subpart B--ORGANIZATION AND PERSONNEL
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| Testing facility management.
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Subpart C--FACILITIES
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| Animal supply facilities.
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| Facilities for handling test and control articles.
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| Laboratory operation areas.
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| Specimen and data storage facilities.
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Subpart D--EQUIPMENT
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| Maintenance and calibration of equipment.
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Subpart E--TESTING FACILITIES OPERATION
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| Standard operating procedures.
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Subpart F--TEST AND CONTROL ARTICLES
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| Test and control article characterization.
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| Test and control article handling.
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| Mixtures of articles with carriers.
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Subpart G--PROTOCOL FOR AND CONDUCT OF A NONCLINICAL LABORATORY STUDY
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| Conduct of a nonclinical laboratory study.
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Subparts H-I--[RESERVED]
Subpart J--RECORDS AND REPORTS
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| Reporting of nonclinical laboratory study results.
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| Storage and retrieval of records and data.
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Subpart K--DISQUALIFICATION OF TESTING FACILITIES
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| Grounds for disqualification.
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| Notice of and opportunity for hearing on proposed disqualification.
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| Final order on disqualification.
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| Actions upon disqualification.
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| Public disclosure of information regarding disqualification.
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| Alternative or additional actions to disqualification.
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| Suspension or termination of a testing facility by a sponsor.
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| Reinstatement of a disqualified testing facility.
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