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Re: Regs regarding I.V. Therapy with Radiopharmaceuticals



I am guessing that this question is with respect to Sr-89 therapy.

10CFR sections 35.32, 35.300, and 35.930 are applicable to therapeutic
administration but do not specifically address intravenous therapy.

In California, Section 30521 of Title 17 addresses supervision requirements
of Nuclear Medicine technologists and says that they shall be under: GENERAL
supervision while performing nuclear medicine technology procedures and
DIRECT supervision while performing ORAL administration of radioactive
material to human beings for therapeutic purposes.  Again, intravenous
therapy is not specifically addressed.  The conservative interpretation
would require, at a minimum, that the technologists be directly supervised
for any systemic radionuclide therapy.  

Your own P&Ps and/or license conditions may require additional restrictions.




...............................reply separator......................
>Is anyone aware of a Federal or State regulation which either requires that a
>physician actually administer an intravenous dose of a therapeutic
>radiopharmaceutical or that prohibits a nuclear medicine technologist from
>administering the dose under the direct (meaning physically present)
>supervision of a physician? 
>
>
*************************************************************************
  Gerald Feldman, M.S.
  Radiation Safety Officer
  UCI Medical Center
  101 City Drive South, Rt. 107
  Orange, California  92668
  Voice:  (714) 456-5607
  FAX:    (714) 634-8639
  E-mail: gfeldman@uci.edu 
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