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The Regulation of Radiopharmaceuticals

James J. Conway, MD
JAMA. 1985;253(21):3093. doi:10.1001/jama.1985.03350450065017.
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To the Editor.—  The recent editorial on the Food and Drug Administration's (FDA) role in the drug approval process is appropriate.1 In our opinion, the FDA has shown concern about infringement upon the practice of medicine.2 Such may not be said for the Nuclear Regulatory Commission (NRC), in its interpretation of its statutory authority to regulate the radiation safety of radiopharmaceuticals in nuclear medicine. It has adopted the FDA package insert as dogma, particularly in respect to the route of injection of the radiopharmaceutical.3 Nuclear Regulatory Commission inspectors have cited nuclear medicine physicians for license non-compliance when they have deviated from the package insert in their practice. The irony of this situation is that one regulatory agency (FDA) issues package insert "guidelines," which do not obligate the practicing physician, while another regulatory agency (NRC) adopts the "guidelines" as dogma in its regulation of nuclear medicine practice.A


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