Abstract
Radiopharmaceuticals are compounds that contain a drug labeled with a radioactive isotope. In the USA, radiopharmaceuticals are considered a special group of medicines bound by complex regulatory elements. Regulatory control of radiopharmaceuticals is primarily under two central federal agencies: the Nuclear Regulatory Commission (NRC) and the Food and Drug Administration (FDA). The principal role of the FDA is to regulate the safety and efficacy of the radioactive drugs as they are used in medical practice, whereas the mission of the NRC is to guarantee the safe use of radioactive materials. Beyond these two federal agencies, oversight of the production, preparation, handling, transport, and use of radiopharmaceuticals is also governed by other regulatory authorities such as the Environmental Protection Agency (EPA), the Occupational Safety and Health Administration (OSHA), and the Department of Transportation (DOT).
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