Which labeling requirement applies to the outer bulk container of a radiopharmaceutical agent?

The labeling requirement that states "Caution radioactive material and amount of radioactivity" is essential in the context of radiopharmaceuticals due to the inherent risks associated with handling and administering radioactive substances. This requirement ensures that anyone who comes into contact with the outer bulk container is immediately aware of the potential hazards related to radioactivity.

Proper labeling serves as a critical safety measure for healthcare professionals, patients, and anyone in proximity to the material. It provides essential information about the radioactivity of the substance, enabling appropriate handling procedures to be followed and minimizing the risk of exposure to harmful radiation.

The inclusion of such warnings is pivotal in maintaining compliance with both federal and state regulations governing radioactive materials. This is not merely a matter of safety; it is also mandated by laws governing the use of radiopharmaceuticals to protect public health. The presence of this specific information on the label helps ensure that all safety protocols are clearly communicated and adhered to by anyone managing these materials.