ML19325D151
| ML19325D151 | |
| Person / Time | |
|---|---|
| Issue date: | 12/02/1988 |
| From: | Cunningham R NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | Dan Collins, Ebneter S, Norelius C NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION I), NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION II), NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION III) |
| Shared Package | |
| ML19325D099 | List: |
| References | |
| RULE-PRM-35-9 NUDOCS 8910190072 | |
| Download: ML19325D151 (2) | |
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MEMORANDUM POR:
Stewart D. Ebneter, Director Division of Radiation $4fety and $4foguards. R!
Douples M. Cellins Acting Director Oty'sion of Radiat!en Safety and Safeguares R!!
7 Charles E. Nerelius, Diretter Division of Radiation Safety and safeguards. R!!!
Richard L. Bangart Director Division of Radiation Safety and safeggeres, RIV l
Ross A. Searneo Director DivisionofRad\\attenSafetyandsafeguards,.RY
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FROM:
Richard E. Cunnin DivisionofInduskhamDirector rialand Medical Nuclear Safety NMS$
$UBJECT:
NOTICE OF INTENT TO REA$$tl$ NRC Ri4ULATIONS AND p0L!CY ON BYPRODUCT RADIOPHARMActVT!CALS Several questions which may affect medical core have been raised in recent correspondence between the NRC and others regarding the human application of byproduct material.
Spacifically, questions regarding the scope of authority 3
of. broad licensees and nuclear pharmacies have been raised as to whether non !ND and non.NDA radiopharmaceuticals may be used in human applications, and.
i if so under what conditions. There is a long history on the sub ect of the regula, tion of the medical uses of radionuclides gains back to at {< east a policy J
statement issued in 1973 and possibly earlier when FDA assumed responsibility for evaluation of radiopharmaceutical safety and efficiency.
NMll is reexamining the issues raised in the regulations and policy statements in this regard and hopes to resolve them shortly. Pending completion of this i
reexaminst'on, a11 proposed enforcement actions on this matter,ld be referred to int,1gding thess involving violations assessed at Severity Levels IV and Y shou j
thisDivisionwithacopytotheOfficeofEnforcementbeforeissuanceinorder l
to ensure consistent and appropriate disposition. Among the actions NMS$ is considering are exemptions and the advisability of amending the regulations.
hl Richard E. Cunnin ham Director DivisionofIndusria$and ne.icai nucie., s.f.ty, NMis r
cc:
C. Kamerer, GPA golg72890605 35-09 PDR i
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