Food and Drug Administration (FDA)
Good Laboratory Practice Standards (GLP)
The Federal Food, Drug and Cosmetics Act and the Public Health Service Act require that manufacturers of products that fall under the regulatory authority of U.S. Food and Drug Administration (FDA) submit evidence that their products are safe. These products include all new color and food additives, animal and human drugs, biological products, electronic products or medical devices. To properly evaluate the safety of these products, the FDA requires that nonclinical studies be "conducted according to scientifically sound protocols and with meticulous attention to quality." The FDA regulates nonclinical studies conducted with animals, plants or microorganisms under Part 58 of Title 21 of the Code of Federal Regulations, "Good Laboratory Practice for Nonclinical Laboratory Studies." The agency enforces compliance with these regulations through regular facility inspections and data audits. Penalties for noncompliance range from written warnings to prosecution.
FDA Good Laboratory Practice for Nonclinical Lab Studies (full text)
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