Nuclear Medicine is the specialty of medical imaging, which utilizes a variety of radionuclides incorporated into specific compounds for diagnostic imaging and therapeutic applications. During recent years, research efforts associated with this discipline have concentrated on the decay characteristics of particular radionuclides and the design of unique radiolabeled tracers necessary to achieve time-dependent molecular images. The specialty is expanding with specific Positron emission tomography (PET) and SPECT radiopharmaceuticals allowing for an extension from functional process imaging in tissue to pathologic processes and nuclide directed treatments. PET is an example of a technique that has been shown to yield the physiologic information necessary for clinical oncology diagnoses based upon altered tissue metabolism. Most PET drugs are currently produced using a cyclotron at locations that are in close proximity to the hospital or academic center at which the radiopharmaceutical will be administered. In November 1997, a law was enacted called the Food and Drug Administration Modernization Act of 1997 which directed the Food and Drug Administration (FDA) to establish appropriate procedures for the approval of PET drugs in accordance with section 505 of the Federal Food, Drug, and Cosmetic Act and to establish current good manufacturing practice requirements for such drugs. At this time the FDA is considering adopting special approval procedures and cGMP requirements for PET drugs. The evolution of PET radiopharmaceuticals has introduced a new class of 'drugs' requiring production facilities and product formulations that must be closely aligned with the scheduled clinical utilization. The production of the radionuclide in the appropriate synthetic form is but one critical component in the manufacture of the finished radiopharmaceutical.
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