ML20210N194
| ML20210N194 | |
| Person / Time | |
|---|---|
| Issue date: | 03/28/1975 |
| From: | Singer B NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| Shared Package | |
| ML20150F580 | List: |
| References | |
| NUDOCS 8610060416 | |
| Download: ML20210N194 (1) | |
Text
_ _ _ _ _ _ _ _
UNITED STATES NUCLEAR REGULATORY COMMISSION 3 W ASHING TON D. C. 20555 f
MAR 2 81975 NRC NOTICE LABELING OF MOLYBDENUM 99/TC 99m GENERATORS A practice has evolved in the radiopharmaceutical industry,of shipping Mo-99/Tc-99m generators with a calibration date that is four to seven days beyond the date of receipt by the user. As a result, the quantity of radioactive material received by the user may be more than four times the nominal activity indicated on the generator label.
The Nuclear Regulatory Connaission (NRC) regards this practice as being contrary to its regulations and good radiological safety practice.
Based on our review of this situation, which included discussions with industry representatives, we have concluded that the following labeling procedure for Mo-99/Tc-99m generators would be consistent with NRC regulatory requirements: the calibration time of Mo-99/Tc-99m generators, dsfined as the time at which the actual activity of the ,
generator will be equal to the activity indicated on the label, should be no more than 48 hours5.555556e-4 days <br />0.0133 hours <br />7.936508e-5 weeks <br />1.8264e-5 months <br /> beyond the time of shipment. Under
) this procedure the actual activity at the time of receipt by the user will exceed the activity indicated on the label by no more than 40% and by less than 10% in most cases.
In order to provide a reasonable time for the generator manufacturers and distributors to make the necessary adjustments (e.g., create new labels, inform their customers of the change in calibration and labeling procedures, etc.), we have set August 4, 1975, as the final date for such changes to be effected.
The above labeling provisions are not applicable to the requirements of the Department of Transportation regulations with respect to labeling of shipping containers.
Sincerely, h~uY Y / sa &~..-
Bernard Singer, Chief Materials Branch Division of Materials and Fuel Cycle Facility Licensing
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19 JAN 1935
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- MAR 2 81975 _
l Atanic Industrial Forum
! Radiopharmaceutical e - fetaa ATTN Dr. Gerald A. Bruno, President f
! 475 Park Avenus South ~
New York, New York 10016 Gene 1====
A pr=ceien has evolved la the radiopharmaceutical i d No-99/Te-993 generators with a calibration data that in ustry of shipping \
saven days beyond the date of recaipt by the user s four to the quantity of r=Aianctive material received b .
As a result,
- than four times the na=inal activity indicated y the user may be more ,
The Noe1==e Regulatory e
' being contrary to its regulations andcalgood radiologimissio safety practica.
i After consideration ci the various proposals t i
" ") which were discussed in a meeting between represo remedy this oftuation, and theas proceed Atomic Industrial Forum on February 27 entktives of the NRC follows: , 1975, we plan to
- 1. i l
I We consider a marinnan advanca emithration tim Mo-99/Te-993 generators to be consistent with NRCe of 48 hours5.555556e-4 days <br />0.0133 hours <br />7.936508e-5 weeks <br />1.8264e-5 months <br /> for 1
requirements, recognizing the short half life of involved. regulatory the m aterials as the tina at which the actual activity of, defined theThis means equal to that indicated on the label, should begenerator will be hours beyond the time of shipment. no more thaa 48 2.
We will notify all NRC medical licann Food and Drug Ad=iai=tration and offiefala orities, the of thma Society, the American Collage of Naeleme e Physi Nucleari MnAietna Amatican than April 11, College 1975.of Nuelmar Medicina of such c ans, and the changes no~later 3.
A copy of the notica is anclased.
Changes 1975. in labeling should be effected no lat s ..
er than August 4, b
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!' Atomic Industrial Forum l^
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i' Advance calibration of other radiopharmaceuti
. sidered on a case-by-case basia. cals will be con-
'l must justify their calibration procedures if theManufacturers and distribut
- i
- ) time of receipt by the usar ascaede the acti i activity at the label by more than 20%.
. v ty indicated on
] 5.
.I These labeling proceduras are expected to be foll hl by all manufacturers and di'stributors licensed owed uniformly by th d
pursuant to Section 32.72 of 10 CFR Part 32. e NRC i-,
I We understand that the Radiopharmaceutical Co f pursue the question of effecting changes in the Ummittee of the AIF will 1
the effective shelf life of radiopharmaceutiso cals.
without reducingthat Comm kei
'We feel that these changes are in th E
and appreciate the cooperation exhibited bya the r die best interests of the p industry. '
opharmaceutical I
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Sincerely,
) Original signed by d 3 -
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Donald %. Nussbaumet
[i Donald A. Nussbaumer '
g U Assistant Director for Materials.
Agreements and Transportation
'l Division of Materials and I Yuel Cycle Facility Licensing
]2
Enclosure:
i
' Notification letter I
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21 JM ;995
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