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The Final Order on Good Laboratory Practices¹

Bureau of Veterinary Medicine, Food and Drug Administration, Rockville, MD 20857

ABSTRACT

On June 20, 1979, the Food and Drug Administration enacted all aspects of its Good Laboratory Practices program. The program was instituted to ensure the quality and integrity of safety data submitted to Food and Drug Administration in support of approval of regulated products, including human and animal drugs, food additives, biologicals, radiation-emitting products, and human medical devices. Moreover, these considerations include all safety data submitted to support applications for research and marketing permits. These steps were taken in response to the appalling circumstances uncovered in a limited series of inspections of laboratories during 1975. Food and Drug Administration found careless experimentation, improperly trained employees, unreviewed data, omitted data, improper laboratory and animal care procedures, and improperly monitored contract studies, including the failure of sponsors to validate the data appearing in the final study reports. The Congress responded to this situation by allocating 600 new positions and $16 million

¹ The complete paper is available in J. Anim. Sci. 51:474.