Good laboratory practice for nonclinical laboratory studies (21 CFR 58.1-58.219).

Part 58 of Title 21 of the Federal Code of Regulations define the necessary rules of good laboratory practice for nonclinical laboratory studies. This Regulation 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 colour additives, animal food additives, human and animal drugs, medical devices for human use, biological products, and electronic products.

Соединенные Штаты Америки · 1978-12-22