What regulatory body oversees the use of radiopharmaceuticals in the United States?

• A. The Nuclear Regulatory Commission
• B. The U.S. Food and Drug Administration (FDA)
• C. The Environmental Protection Agency
• D. The Department of Health and Human Services

Answer: (B)

The United States Food and Drug Administration (FDA) is the primary regulatory body that oversees the use of radiopharmaceuticals. The FDA's role includes ensuring that all medications, including radiopharmaceuticals, are safe and effective for the intended use. This involves the evaluation of clinical studies that demonstrate the efficacy and safety of radiopharmaceuticals in diagnosing and treating diseases.

Radiopharmaceuticals must undergo rigorous review processes before they can be utilized in clinical practice. This includes assessing their dosimetry, pharmacokinetics, and any potential adverse effects. Once approved, the FDA continues to monitor the safety of these products through post-marketing surveillance.

While other agencies, such as the Nuclear Regulatory Commission (NRC), play significant roles in regulating the handling and use of radioactive materials, they do not directly oversee the approval of radiopharmaceuticals as medical products. The Environmental Protection Agency (EPA) focuses more on environmental impacts related to radiation and safe levels of radioactive emissions, whereas the Department of Health and Human Services (HHS) encompasses broader health policies and initiatives.