[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]
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