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Electronic Code of Federal Regulations

e-CFR data is current as of November 14, 2019

Title 21Chapter ISubchapter APart 58


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

rule

Subpart A—GENERAL PROVISIONS

§58.1
Scope.
§58.3
Definitions.
§58.10
Applicability to studies performed under grants and contracts.
§58.15
Inspection of a testing facility.
rule

Subpart B—ORGANIZATION AND PERSONNEL

§58.29
Personnel.
§58.31
Testing facility management.
§58.33
Study director.
§58.35
Quality assurance unit.
rule

Subpart C—FACILITIES

§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.
rule

Subpart D—EQUIPMENT

§58.61
Equipment design.
§58.63
Maintenance and calibration of equipment.
rule

Subpart E—TESTING FACILITIES OPERATION

§58.81
Standard operating procedures.
§58.83
Reagents and solutions.
§58.90
Animal care.
rule

Subpart F—TEST AND CONTROL ARTICLES

§58.105
Test and control article characterization.
§58.107
Test and control article handling.
§58.113
Mixtures of articles with carriers.
rule

Subpart G—PROTOCOL FOR AND CONDUCT OF A NONCLINICAL LABORATORY STUDY

§58.120
Protocol.
§58.130
Conduct of a nonclinical laboratory study.
rule

Subparts H-I [Reserved]

rule

Subpart J—RECORDS AND REPORTS

§58.185
Reporting of nonclinical laboratory study results.
§58.190
Storage and retrieval of records and data.
§58.195
Retention of records.
rule

Subpart K—DISQUALIFICATION OF TESTING FACILITIES

§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.

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