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 |
Sec. 58.1 Scope. |
(a) This part prescribes good laboratory practices for conducting nonclinical laboratory studies that support or areintended 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 tosections 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 FR399, Jan. 5, 1999] |
Sec. 58.3 Definitions. |
As used in this part, the following terms shall have the meanings specified:(a)Act means the Federal Food, Drug, and Cosmetic Act, as amended (secs. 201-902, 52 Stat. 1040et seq., as amended (21 U.S.C. 321-392)).(b)Test article means any food additive, color additive, drug, biological product, electronic product, medical device for humanuse, or any other article subject to regulation under the act or under sections 351 and 354-360F of the Public Health Service Act.(c)Control article means any food additive, color additive, drug, biological product, electronic product, medical device for human use, or any article other than a test article, feed, or water that is administered to the test system in the course of a nonclinicallaboratory study for the purpose of establishing a basis for comparison with the test article.(d)Nonclinical laboratory study means in vivo or in vitro experiments in which test articles are studied prospectively in test systems under laboratory conditions to determine their safety. The term does not include studies utilizing human subjects or clinical studies or field trials in animals. The term does notinclude basic exploratory studies carried out to determine whether a test article has any potential utility or to determine physical or chemical characteristics of a test article.(e)Application for research or marketing permit includes:(1) A color additive petition, described in part 71.(2) A food additive petition, described in parts 171 and 571.(3) Data and information regarding a substancesubmitted as part of the procedures for establishing that a substance is generally recognized as safe for use, which use results or may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristics of any food, described in 170.35 and 570.35.(4) Data and information regarding a food additive submitted as part of the proceduresregarding food additives permitted to be used on an interim basis pending additional study, described in 180.1.(5) Aninvestigational new drug application, described in part 312 of this chapter.(6) Anew drug application, described in part 314.(7) Data and information regarding an over-the-counter drug for human use, submitted as part of the procedures for classifying such drugs as generally recognized assafe and effective and not misbranded, described in part 330.(8) Data and information about a substance submitted as part of the procedures for establishing a tolerance for unavoidable contaminants in food and food-packaging materials, described in parts 109 and 509.(9) [Reserved](10) ANotice of Claimed Investigational Exemption for a New Animal Drug, described in part 511.(11) Anew animal drug...