cfr_sections: 21:21:1.0.1.1.22.1.98.1

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section_id	title_number	title_name	chapter	subchapter	part_number	part_name	subpart	subpart_name	section_number	section_heading	agency	authority	source_citation	amendment_citations	full_text
21:21:1.0.1.1.22.1.98.1	21	Food and Drugs	I	A	58	PART 58—GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES	A	Subpart A—General Provisions	58.1	§ 58.1 Scope.	FDA	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.	43 FR 60013, Dec. 22, 1978, unless otherwise noted.	[43 FR 60013, Dec. 22, 1978, as amended at 52 FR 33779, Sept. 4, 1987; 64 FR 399, Jan. 5, 1999]	(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.