Re: Lymphoscintigraphy

["Mike Bohan" <mike.bohan@yale.edu>]

        Reply to:   RE>Lymphoscintigraphy

Hi RadSafers:

My understanding is that current NRC regulations allow an authorized nuclear
pharmacist or authorized human use user to depart from the manufacturers package
insert instructions as long as they meet Subpart J. requirements.  If you look
in the current regs. you won't find this specifically stated.  The NRC's old
regs. specifically required that licensees follow the package insert
instructions.  When they changed the regs. they deleted the restrictions but
don't specifically state that you can now do this.  

For more info, see the discussion of the proposed rule making published in the
Fed. Register 58 FR33396, 6/17/93.  It is also available in the loose leaf
version of 10 CFR on pages 35-PR-12 thru 31.

They made this an item of compliance for agreement states, but some provisions
are division 1 while others are division 2.  So, in Texas you need to check for
state applicability.

Hope this helps,


<><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><
Michael J. Bohan, RSO   |  e-mail: mike.bohan@yale.edu
Yale-New Haven Hospital |    Tele: (203) 785-2950
Radiological Physics    |     FAX: (203) 737-4252
20 York St. - WWW 204   |    As usual, everything I say may be plausibly
New Haven, CT    06504  |    denied at my employer's convenience ...
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--------------------------------------
Date: 13/05/97 12:46 PM
To: Mike Bohan
From: radsafe@romulus.ehs.uiuc.edu
Does anyone know if Tc-99m sulfur colloid is approved for
lymphoscintigraphy?  I have been informed that since it is not
specifically stated in the package insert, it is not approved for this
use according to regulatory authorities.  Thank you.


David Engelbretson
Department of Medical Physics
The Methodist Hospital
Houston, Texas

dengelbretson@tmh.tmc.edu