Regulatory Oversight of Radiopharmaceuticals

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 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 Environmental Protection Agency (EPA), Occupational Safety and Health Administration (OSHA), and the Department of Transportation (DOT).

The regulations set forth by these federal agencies may be administered at the state level. For example, State Boards of Pharmacy govern the practice of pharmacy; State Departments of Health Services may oversee matters relating to radiation exposure to the public; and State Departments of Environmental Quality manage the radioactive waste programs. Additionally, for most large hospitals there also exists an additional internal or local regulatory layer to ensure compliance with appropriate federal and state regulations.

The purpose of this chapter is to offer a basic understanding of the regulations that govern the preparation, handling, and use of radiopharmaceuticals in a hospital nuclear medicine department. The aim is to assist healthcare providers to better navigate the steadily increasing regulatory oversight surrounding the use of radioactive materials. There is a high level of expectation from these oversight organizations and full compliance is mandatory in order to continue the necessary nuclear medicine procedures.