[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR58.1]

[Page 303]
 
                        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 
 
                      Subpart A_General Provisions
 
Sec.  58.1  Scope.


    (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]