[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2005]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR58.1]

[Page 300-301]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES
 
PART 58_GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES
--Table of Contents
 
                      Subpart A_General Provisions
 
Sec. 58.1  Scope.




                      Subpart A_General Provisions

Sec.
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 Mixture 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.

[[Page 301]]

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.



    (a) This part prescribes good laboratory practices for conducting 
nonclinical laboratory studies that support or are intended to support 
applications for research or marketing permits for products regulated by 
the Food and Drug Administration, including food and color additives, 
animal food additives, human and animal drugs, medical devices for human 
use, biological products, and electronic products. Compliance with this 
part is intended to assure the quality and integrity of the safety data 
filed pursuant to sections 406, 408, 409, 502, 503, 505, 506, 510, 512-
516, 518-520, 721, and 801 of the Federal Food, Drug, and Cosmetic Act 
and sections 351 and 354-360F of the Public Health Service Act.
    (b) References in this part to regulatory sections of the Code of 
Federal Regulations are to chapter I of title 21, unless otherwise 
noted.

[43 FR 60013, Dec. 22, 1978, as amended at 52 FR 33779, Sept. 4, 1987; 
64 FR 399, Jan. 5, 1999]