Which regulatory body must nuclear pharmacies comply with?

Nuclear pharmacies must comply with the regulations set forth by the U.S. Nuclear Regulatory Commission (NRC). The NRC is the federal agency responsible for regulating the nation’s civilian use of radioactive materials, including those used in nuclear pharmacies for preparing and dispensing radiopharmaceuticals. Compliance with NRC regulations is crucial for ensuring safety in the handling, storage, and disposal of radioactive substances, which can pose significant health risks if mismanaged.

Nuclear pharmacies must adhere to the NRC guidelines not only to ensure the safe use of these materials but also to meet the standards for licensing, facility requirements, and staff training. This regulatory oversight helps maintain a high standard of public health and safety regarding the use of radioactive drugs in diagnostic and therapeutic procedures, which is essential for patient care in the field of nuclear medicine.

While other regulatory bodies, such as the Food and Drug Administration (FDA) and the State Board of Pharmacy, also play roles in ensuring the safety and efficacy of pharmaceutical products, they do not specifically govern the use of radioactive materials to the same extent as the U.S. Nuclear Regulatory Commission. The Environmental Protection Agency (EPA) is more focused on environmental impacts rather than the specific regulations surrounding the handling of radioactive drugs in a pharmacy setting.