What is the primary regulatory body overseeing radiopharmacy practices in the United States?

The Nuclear Regulatory Commission (NRC) is the primary regulatory body overseeing radiopharmacy practices in the United States due to its specific mandate concerning the regulation of radioactive materials and their safety. The NRC ensures that the use of radioactive substances in medicine, including those used in radiopharmacy, meets strict safety standards to protect public health and the environment. This includes overseeing the licensing of radioactive materials, enforcing regulations governing their use, and ensuring compliance with safety practices in facilities where radiopharmaceuticals are prepared and administered.

While the Food and Drug Administration (FDA) plays a critical role in the approval and regulation of pharmaceuticals, including radiopharmaceuticals, its focus is primarily on the effectiveness and safety of drugs rather than on the broader regulatory aspects associated with the handling and use of radioactive materials. The Environmental Protection Agency (EPA) is primarily focused on environmental protection and the management of hazardous substances, and while it may have overlapping interests, it does not regulate radiopharmacy practices directly. The Department of Health and Human Services (DHHS) oversees public health programs and services, but it does not specifically regulate radiopharmaceutical practice or the use of radioactive materials. Thus, the NRC’s unique focus on nuclear materials makes it the appropriate authority in this context.