ABSTRACT
Radiopharmaceuticals are pharmaceuticals that are radioactive and are used either for diagnostic or therapeutic purposes. In addition to the presence of radioactivity, radiopharmaceuticals are distinguished from traditional pharmaceuticals in a number of ways. In contrast to conventional pharmaceuticals, radiopharmaceuticals can have a range of stabilities, and the activity of these compounds is highly dependent on the stability of the substance. The regulation of radiopharmaceuticals also falls under the purview of the drug regulatory authority, which does not permit any easing of GMP requirements anywhere in the world. The regulatory requirements for the United States, the European Union, and India are comparable and will be addressed here.
