Title 21

PART 58

Part 58 - Good Laboratory Practice For Nonclinical Laboratory Studies

PART 58 - GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES 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.

21:1.0.1.1.23.1SUBPART A
Subpart A - General Provisions
21:1.0.1.1.23.1.63.1SECTION 58.1
   58.1 Scope.
21:1.0.1.1.23.1.63.2SECTION 58.3
   58.3 Definitions.
21:1.0.1.1.23.1.63.3SECTION 58.10
   58.10 Applicability to studies performed under grants and contracts.
21:1.0.1.1.23.1.63.4SECTION 58.15
   58.15 Inspection of a testing facility.
21:1.0.1.1.23.2SUBPART B
Subpart B - Organization and Personnel
21:1.0.1.1.23.2.63.1SECTION 58.29
   58.29 Personnel.
21:1.0.1.1.23.2.63.2SECTION 58.31
   58.31 Testing facility management.
21:1.0.1.1.23.2.63.3SECTION 58.33
   58.33 Study director.
21:1.0.1.1.23.2.63.4SECTION 58.35
   58.35 Quality assurance unit.
21:1.0.1.1.23.3SUBPART C
Subpart C - Facilities
21:1.0.1.1.23.3.63.1SECTION 58.41
   58.41 General.
21:1.0.1.1.23.3.63.2SECTION 58.43
   58.43 Animal care facilities.
21:1.0.1.1.23.3.63.3SECTION 58.45
   58.45 Animal supply facilities.
21:1.0.1.1.23.3.63.4SECTION 58.47
   58.47 Facilities for handling test and control articles.
21:1.0.1.1.23.3.63.5SECTION 58.49
   58.49 Laboratory operation areas.
21:1.0.1.1.23.3.63.6SECTION 58.51
   58.51 Specimen and data storage facilities.
21:1.0.1.1.23.4SUBPART D
Subpart D - Equipment
21:1.0.1.1.23.4.63.1SECTION 58.61
   58.61 Equipment design.
21:1.0.1.1.23.4.63.2SECTION 58.63
   58.63 Maintenance and calibration of equipment.
21:1.0.1.1.23.5SUBPART E
Subpart E - Testing Facilities Operation
21:1.0.1.1.23.5.63.1SECTION 58.81
   58.81 Standard operating procedures.
21:1.0.1.1.23.5.63.2SECTION 58.83
   58.83 Reagents and solutions.
21:1.0.1.1.23.5.63.3SECTION 58.90
   58.90 Animal care.
21:1.0.1.1.23.6SUBPART F
Subpart F - Test and Control Articles
21:1.0.1.1.23.6.63.1SECTION 58.105
   58.105 Test and control article characterization.
21:1.0.1.1.23.6.63.2SECTION 58.107
   58.107 Test and control article handling.
21:1.0.1.1.23.6.63.3SECTION 58.113
   58.113 Mixtures of articles with carriers.
21:1.0.1.1.23.7SUBPART G
Subpart G - Protocol for and Conduct of a Nonclinical Laboratory Study
21:1.0.1.1.23.7.63.1SECTION 58.120
   58.120 Protocol.
21:1.0.1.1.23.7.63.2SECTION 58.130
   58.130 Conduct of a nonclinical laboratory study.
21:1.0.1.1.23.8SUBPART H
Subparts H-I [Reserved]
21:1.0.1.1.23.9SUBPART J
Subpart J - Records and Reports
21:1.0.1.1.23.9.63.1SECTION 58.185
   58.185 Reporting of nonclinical laboratory study results.
21:1.0.1.1.23.9.63.2SECTION 58.190
   58.190 Storage and retrieval of records and data.
21:1.0.1.1.23.9.63.3SECTION 58.195
   58.195 Retention of records.
21:1.0.1.1.23.10SUBPART K
Subpart K - Disqualification of Testing Facilities
21:1.0.1.1.23.10.63.1SECTION 58.200
   58.200 Purpose.
21:1.0.1.1.23.10.63.2SECTION 58.202
   58.202 Grounds for disqualification.
21:1.0.1.1.23.10.63.3SECTION 58.204
   58.204 Notice of and opportunity for hearing on proposed disqualification.
21:1.0.1.1.23.10.63.4SECTION 58.206
   58.206 Final order on disqualification.
21:1.0.1.1.23.10.63.5SECTION 58.210
   58.210 Actions upon disqualification.
21:1.0.1.1.23.10.63.6SECTION 58.213
   58.213 Public disclosure of information regarding disqualification.
21:1.0.1.1.23.10.63.7SECTION 58.215
   58.215 Alternative or additional actions to disqualification.
21:1.0.1.1.23.10.63.8SECTION 58.217
   58.217 Suspension or termination of a testing facility by a sponsor.
21:1.0.1.1.23.10.63.9SECTION 58.219
   58.219 Reinstatement of a disqualified testing facility.