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NRC and FDA Regulations Affecting Nuclear Pharmacy Practice

Radiopharmaceuticals are radioactive drugs that are used in nuclear medicine practice for diagnosis and treatment of disease. Nuclear pharmacy practice is a patient-oriented pharmaceutical service that promotes the safe and efficacious use of radiopharmaceuticals and other drugs used in nuclear medicine, and is regulated jointly by a variety of federal, state, and local agencies. Given that the medical use of radiopharmaceuticals is highly regulated at multiple levels of government, it is not surprising that nuclear pharmacy practice is conducted in a complex regulatory environment. The purpose of this article is to provide a brief overview of this regulatory environment, primarily in terms of two important regulatory agencies involved (Nuclear Regulatory Commission and Food and Drug Administration), their primary authority and activities, and the regulations that must be satisfied in order to assure the safe and efficacious use of radiopharmaceuticals.