Part 58 — Good Laboratory Practice for Nonclinical Laboratory Studies
Current through Sep 8, 2026
Authority: 21 U.S.C. 342, 346, 346a, 348, 351, 352, 353, 355, 360, 360b-360f, 360h-360j, 371, 379e, 381; 42 U.S.C. 216, 262, 263b-263n.
Source: 43 FR 60013, Dec. 22, 1978, unless otherwise noted.
Sections
- § 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.