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Title 21 - Food and Drugs
CHAPTER I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
PART 58 - GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES
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| 58-1 | Scope. | ||
| 58-3 | Definitions. | ||
| 58-10 | Applicability to studies performed under grants and contracts. | ||
| 58-15 | Inspection of a testing facility. | ||
| 58-29 | Personnel. | ||
| 58-31 | Testing facility management. | ||
| 58-33 | Study director. | ||
| 58-35 | Quality assurance unit. | ||
| 58-41 | General. | ||
| 58-43 | Animal care facilities. | ||
| 58-45 | Animal supply facilities. | ||
| 58-47 | Facilities for handling test and control articles. | ||
| 58-49 | Laboratory operation areas. | ||
| 58-51 | Specimen and data storage facilities. | ||
| 58-61 | Equipment design. | ||
| 58-63 | Maintenance and calibration of equipment. | ||
| 58-81 | Standard operating procedures. | ||
| 58-83 | Reagents and solutions. | ||
| 58-90 | Animal care. | ||
| 58-105 | Test and control article characterization. | ||
| 58-107 | Test and control article handling. | ||
| 58-113 | Mixtures of articles with carriers. | ||
| 58-120 | Protocol. | ||
| 58-130 | Conduct of a nonclinical laboratory study. | ||
| 58-185 | Reporting of nonclinical laboratory study results. | ||
| 58-190 | Storage and retrieval of records and data. | ||
| 58-195 | Retention of records. | ||
| 58-200 | Purpose. | ||
| 58-202 | Grounds for disqualification. | ||
| 58-204 | Notice of and opportunity for hearing on proposed disqualification. | ||
| 58-206 | Final order on disqualification. | ||
| 58-210 | Actions upon disqualification. | ||
| 58-213 | Public disclosure of information regarding disqualification. | ||
| 58-215 | Alternative or additional actions to disqualification. | ||
| 58-217 | Suspension or termination of a testing facility by a sponsor. | ||
| 58-219 | Reinstatement of a disqualified testing facility. | ||