Re: Radiation Exposure Limits for Research Subjects

["Dale E. Boyce" <dale@radpro.uchicago.edu>]

Steve,

Our Human Use / Radioactive Drug Research Committee tries to
follow 21 CFR 361.1 for all protocols as far as exposures are
concerned.  There has been a great deal of discussion as to
when 21 CFR 361.1 must be followed.  With F-18 FDG for example,
the isotope is made in house, labeled in house, and administered.
Since glucose is not an experimental drug 21 CFR does not apply.
FDG is (was I have been told that it is now an approved procedure)
a fairly clear example of a procedure that is relatively unregulated.

The waters become muddy when you have an experimental drug that
is labeled in house.  Do federal regs apply, or is it up to the
individual state's pharmacy and medical practice regulations?

Exposure limits in 21 CFR do not address extremety or define
whole body exposures as does 10 CFR.  This raises the question
of upper arm exposures in procedures using very short half-life
materials such as O-15.  I would be interested in hearing what
other institutions use as guidelines for approving Human Use
Protocols.  It seeems to be a very gray area from a regulatory
standpoint.

Dale E. Boyce
dale@radpro.uchicago.edu