ML20137R926
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e*C UNITED STATES &A1H NUCLEAR REGULATORY COMMISSION
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MEMORANDUM FOR: Vandy L. Miller, Chief Material Licensing Branch William J. Walker, Ph.D., Section Leader ,
Medical.and Academic Section Material Licensing Branch John E. Glenn, Ph.D., Section Leader Region I Licensing Section Technical Staff Medical Licensing Sections Material Licensing Branch
- FROM: Bruce S. Mallett, Ph.D., Section Leader Region III Licensing Section
SUBJECT:
TRANSFER OF RADT0 ACTIVE MATERIALS BE WEEN NRC LICENSED MEDICAL INSTITUTIONS - SITUATIONS TilAT DO NOT REQUIRE THE TRANSFER 0R TO OBTAIN A DISTRIBUTION LICENSE
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- Section 35.14(b) of 10CFR Part 35 requires group medical licensees i
to obtain radioactive materials from institutions that possess a
- . distribution license in accordance with Section 32.72,of 10CFR Part 32.
During the past year, however, there have been a numb'er of requests by medical licensees to receive radioactive materials from an institution that does not possess a distribution license. ' In order to establish a standard review plan that would allow for the approval and a uniform review of these requests, representatives of Region I, Region III, and Headquarters Medical Licensing Sections held a workshop on November 20, 1981. The following is a summary of the review criteria proposed at that workshop.
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APPLICABILITY
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( ) Since the review and approval of requests of this nature requires an x ,/ exemption from the requirements of Section 35.14(b) of 10CFR Part 35, these requests shall be reviewed on a case-by-case basis and be limited to the following situations:
l '. Transfers between no more than three institutions.
- 2. Transfers between more than two institutions shall be in only one direction (i.e. from one institution to the other two).
- 3. Transfers between two institutions may be in both directions.
- 4. The agent transferring the materials shall be one of the participating institutions or a common carrier and not a
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- 5. All participating institutions shall have the proper procedures established to safely handle and be licensed to possess and use the material that will be transferred.
- 6. Any form of radioactive material may be transferred.
- 7. If Mo-99/Tc-99m generators are to be transferred, they shall
,s not be altered from their original state and past their cxpiration date. p/c,& q ,- ,ujw7yd5) v
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- 8. Transfers involving therapeutic levels of radiopharmaceuticals shall be limited to-the transfer of prepared radiopharmaceuticals
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. 'idicived from an -i#st-itution licensed in accordance with 10CFR
?M 32. 72 Ti'e 14eensees w'i,11 not be permitted to receive 100 mci of iodine-131 as a prepar,ed dose for therapy and break down that dose into smaller portions for transfer to other institutions).
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- 9. Transfers from one institution to another-institution operating avr a mobile van shall not be allowed. . ._
- 10. Transfers involving the redistribution of unaltered packages ~
of prepared radioactive materials shall be allowed.
Licensees shall be required to obtain distribution licenses if they desire to transfer radioactive material to medical institutions in situations other than those listed above (e.g. transfers between more than three institutions).
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INFORMATION THAT SHOULD BE SUBMITTED BY APPLICA.rs Y
- 1. Confirmation that receipt and package opening procedures shall be at least equivalent to those outlined in Appendix F of Regulatory Guide 10.8, October 1980.
- 2. Concurrence.from the administrator of each participating institution.
- 3. If the request is for redistribution to general licensees, the transferor should be advised to check for the proper labeling and
- f. to not alter the packages.
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- 4. For transfers involving Group VI sources, procedures for maintaining source accountability at all participating institutions.
- 5. Confirmation that vehicles used for transporting materials will be surveyed for contamination.
i j 6. Safety measures to be used in transporting the radioactive materials
- in the applicants' vehicles (e.g. security against unauthorized removal, 4
away from passenger compartment, absorbent paper, lead shields, etc.).
j 7. Identification of the individuals who will transport the materials, and the training they will receive. This training should, as a minimuu, j include all the items outlined in 10 CFR 19.12 and decontamination procedures in case of spills.
} 8. Emergency procedures to be. followed in case of accidents involving
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- spills or loss of radioactive materials.
- 9. Identification of each type and quantity of radiopharmaceutical that will be transported (e.g. unit doses of Tc-sulfur colloid, etc.).
h ./// a Bruce S. Mallett, Section Leader Region III Licensing Section
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