CFR - Code of Federal Regulations Title 21

The information on this page is current as of Dec 22, 2023.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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

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.

Subpart B - Organization and Personnel
   § 58.29 - Personnel.
   § 58.31 - Testing facility management.
   § 58.33 - Study director.
   § 58.35 - Quality assurance unit.

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.

Subpart D - Equipment
   § 58.61 - Equipment design.
   § 58.63 - Maintenance and calibration of equipment.

Subpart E - Testing Facilities Operation
   § 58.81 - Standard operating procedures.
   § 58.83 - Reagents and solutions.
   § 58.90 - Animal care.

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.

Subpart G - Protocol for and Conduct of a Nonclinical Laboratory Study
   § 58.120 - Protocol.
   § 58.130 - Conduct of a nonclinical laboratory study.

Subparts H-I [Reserved]

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.

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.

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.