ML19296F386
| ML19296F386 | |
| Person / Time | |
|---|---|
| Issue date: | 02/21/1980 |
| From: | Davis A NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION III) |
| To: | Higginbotham L NRC OFFICE OF INSPECTION & ENFORCEMENT (IE) |
| Shared Package | |
| ML19296F381 | List: |
| References | |
| REF-SSINS-6100, REF-SSINS-SSINS-6 NUDOCS 8010210236 | |
| Download: ML19296F386 (1) | |
Text
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pm arCog UNITED STATES f_
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GLEN ELLYN, ILLINOIS 40137
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Feb ruary 21, 1980 MEMORANDUM FOR:
L. B. Higginbotham, Assistant Director, Division of Fuel Facility and Materials Safety Inspection, IE FROM:
A B. Davis, C1lef, Fuel Facility and Materials Safety Branch, RIII
SUBJECT:
IML TRANSFER OF Tc-99m DOSES BE'IWEEN LICENSED NRC FACILITIES (AITS NO. F03017780)
During recent inspections of Isotope Measurements Laboratories (IML) and two client-hospitals, the inspectors noted an IML technologist eluted a molybdenum / technetium generator received by a client-hospital, prepared individual doses and transferred this material to three other IML serviced hospitals which were authorized by an NRC license to receive this radio-pharmaceutical. This procedure is conducted on a routine basis.
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IML is not licensed under 10 CFR Part 32.72.
An amendment request for authorization to elute generators and transpo;t the eluates to NRC
[,licensedfacilitieswasdeniedApril 27, 1979 by the License Management g
Branch, Division of Fuel Cycle and Material Safety.
l IML personnel stated authorization for transfer is based on a March 31, 1971 letter signed by the Assistant Chief of Materials Licensing, the Atomic Energy Commission. This letter (enclosed) confirms a licensed hospital using Tc-99m =ay furnish this material to appropriately licensed hospitals provided the product transferred is suitable for human use regarding sterility, pyrogenicity, and radioactive assay.
Please reassess the statements of the March 31, 1971 letter.and-provide an interpretation of the IML position with regard to 10 CFR 35.14(a)(21)which requires a licensen to receive Group III material from a-distributor ?
licensed under 10 CFR Part 32.73.
Note that 10 CFR 35.14 became effective in 1974, subsequent to the March 31, 1971 letter.
f TYWV If further information is required, please contact C. T. Oberg (384-2512) or N. A. Nicholson (384-2525).
NN A 3
A. B. Davis, Chief Fuel Facility and Materials Safety Branch
Enclosure:
as stated
- 040 g