In the United States, the Food and Drug Administration (FDA) and similar government departments must approve a substance as a drug before it can be sold.

In the U.S., the Food and Drug Administration (FDA) must approve a substance as a drug before it can be marketed. The approval process involves several steps including pre-clinical laboratory and animal studies, clinical trials for safety and efficacy, filing of a New Drug Application by the manufacturer of the drug, FDA review of the application, [..]