Regulatory Authority of Accelerator Products on Indian Reservations

["Huston, Thomas E" <HustonThomasE@UAMS.EDU>]

This is somewhat of an obscure question...but someone asked me and I do not

know the answer.

Anyway, here's the question:



What regulatory agency is responsible for licensing possession and use of

accelerator-generated radionuclides on U.S. Indian Reservations (e.g.,

cyclotron-generated PET radiopharmaceuticals)?



I asked the NRC (via their website/Public Affairs) and was simply and

literally told "The Food and Drug Administration" (with no other details).

I am not satisified with this answer.  I realize that this is partially true

in the sense that the FDA regulates pharmaceuticals....but who regulates

their use with respect to radiation exposure on Indian Reservations.



Anyone have any comments?



Tom Huston

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