Counsel Stack
|
Law
Browse
Pricing
Counsel Stack
API Docs
Home
/
CFR
/
Title 21
/
Part 58
FEDERAL · 21 CFR
Part 58 — Good Laboratory Practice for Nonclinical Laboratory Studies
36 sections · Title 21: Food and Drugs
§ 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.