ML20205C882
| ML20205C882 | |
| Person / Time | |
|---|---|
| Issue date: | 08/01/1986 |
| From: | Whiston P NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION III) |
| To: | Mason T MEDICAL PHYSICS CONSULTANTS, INC. |
| Shared Package | |
| ML20205C889 | List: |
| References | |
| NUDOCS 8608140479 | |
| Download: ML20205C882 (1) | |
Text
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AUG 1 1986 Medical Physics Consultants, Inc.
ATTN: Tony R. Mason, M.S.
Medical Radiation Physicist 3200 West Liberty Suite F1 Ann Arbor, MI 48103 Gentlemen:
Enclosed is an April 1,1981 copy of an " Abbreviated Summary of Approved Radiopharmaceutical Drug Products" which contains the Isotex product "Glofil-125" (see Item 14 of enclosure) referenced in your March 27, 1986 letter. This product can be used by Group I licensees.
Please refer to 10 CFR Part 35, Section 35.100, Scheduled A, Item (a)(2) which lists iodine-125 as sodium iothalamate (Glofil-125) for diagnostic studies involving measurements of uptake dilution and excretion (e.g., glomerular filtration rate).
Pleasealsonotethat10CFRPart35,Section35.100,ScheduleA, Item (b)(2) lists iodine-125 as sodium iodide or fibrinogen to be used for diagnostic imaging and localization. Therefore, licensees' authorized for Groups I and II may use the "Glofil-125" as a Group I procedure, not a Group II procedure.
If you have any questions or require clarification on any of the information stated above, you may contact us at (312) 790-5625.
Sincerely, Patricia J. Whiston Materials Licensing Section
Enclosures:
1.
Abbreviated Sumary of Approved Radiopharmaceutical Drug Projects 2.
10 CFR Part 35 R II d
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