ML19296F392
| ML19296F392 | |
| Person / Time | |
|---|---|
| Issue date: | 07/18/1979 |
| From: | Kerr G NRC OFFICE OF STATE PROGRAMS (OSP) |
| To: | Hazle A COLORADO, STATE OF |
| Shared Package | |
| ML19296F381 | List: |
| References | |
| REF-SSINS-6100, REF-SSINS-SSINS-6 NUDOCS 8010210255 | |
| Download: ML19296F392 (2) | |
Text
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$~/h]f REF:
SA/IAB Mr. Albert J. Hazle, Director Radiation & Hazardous Waste control Division Office of Health Protection Deparbant of Public Health 4210 East lith Avenue s'
Denver, Colorado 80220
Dear lir. Ha=le:
This is in response to your June 14, 1979 letter requesting NRC's interpretation of 10 CFR 35.14(b) as related to the' following:
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1.
Radiopharmacies which are licensed to only distribute individual doses which have been prepared from radio-pharmaceuticals, generators, and/or reagent kits manu-factured under 32.72 and 32.73.
e m(j In o:cer to distribute radiopharmaceuticals, generators, and/or reagent kits to Group medical licensees, radio-pharmacies must be licensed pursuant to 10 CFR 32.72 and 32.73.
2.
One hospital which supplies radiopharmaceuticals, reagent kits, and/or individual doses to a second hospital on an emergency basis only (i.e., the second hospital has tenporarily run out).
Emergency transfers of radiopharmaceuticals, reagent kits, and/or individual doses from one Group medital licensee to another are technically a violation of 10 CFR 35.14(b).
However, NRC probably would not take any enforcement action because of the extenuating circumstances (i.e., medical emergency).
NRC does not require a specific license condition (such as that chown in Item 3 below) if the transfers are both very rare (i.e., or.ce or twice a year) and necessitated by a
, medical emergency.
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3.2 One hospital which routinely supplies a second hospital with pharmaceuticals and/or reagent kits manufactured under 32.72 and 32.73.
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Routine transfers from one Group medical licensee to another may be authorized by a specific license condition that reads:
"Notwithstanding the' requirements of section 35.14(b) of 10 CFR Part 35, the licensee may *obtain licensed material from (Name and Address of supplier).."
It should be noted that this license condition is used when one Group medical licensee supplies materials to one or two other Group. medical licensees.
Larger operations must be licensed pursuant to 10 CFR 32.72 and 32.73.
Please contact us again if you have further questions. -
Sincerely, og G. Wayne Kerr, Assistant Director for State Agreements Program Office of State Programs g
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