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UNITED STATES

NUCLEAR REGULATORY COMMISSION 3

W ASHING TON D. C. 20555

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MAR 2 81975

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NRC NOTICE

LABELING OF MOLYBDENUM 99/TC 99m GENERATORS

A practice has evolved in the radiopharmaceutical industry,of shippingMo-99/Tc-99m generators with a calibration date that is four toseven days beyond the date of receipt by the user. As a result, thequantity of radioactive material received by the user may be morethan four times the nominal activity indicated on the generator label.The Nuclear Regulatory Connaission (NRC) regards this practice asbeing contrary to its regulations and good radiological safety practice.

Based on our review of this situation, which included discussionswith industry representatives, we have concluded that the followinglabeling procedure for Mo-99/Tc-99m generators would be consistentwith NRC regulatory requirements: the calibration time of Mo-99/Tc-99mgenerators, dsfined as the time at which the actual activity of the

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generator will be equal to the activity indicated on the label,should be no more than 48 hours beyond the time of shipment. Under

) this procedure the actual activity at the time of receipt by theuser will exceed the activity indicated on the label by no morethan 40% and by less than 10% in most cases.

In order to provide a reasonable time for the generator manufacturersand distributors to make the necessary adjustments (e.g., create newlabels, inform their customers of the change in calibration andlabeling procedures, etc.), we have set August 4, 1975, as the finaldate for such changes to be effected.

The above labeling provisions are not applicable to the requirementsof the Department of Transportation regulations with respect tolabeling of shipping containers.

Sincerely,.

h~uY Y / sa &~..-Bernard Singer, Chief

'Materials BranchDivision of Materials andFuel Cycle Facility Licensing

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8610060416 850816% REG 3 LIC30'/rs.3916 1924-04206-05MD PDR '-

JAN 1935

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MAR 2 81975_

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| 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 dNo-99/Te-993 generators with a calibration data that in ustry of shipping

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saven days beyond the date of recaipt by the user s four tothe quantity of r=Aianctive material received b

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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 and good radiologimission (MRC) regards this practica ason the generator label.i

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cal safety practica.After consideration ci the various proposals twhich were discussed in a meeting between represo remedy this oftuation,

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" ") and the Atomic Industrial Forum on February 27 entktives of the NRC'

proceed as follows: , 1975, we plan to1. i

We consider a marinnan advanca emithration tim l

Mo-99/Te-993 generators to be consistent with NRCe of 48 hours for 1

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requirements, recognizing the short half life of the mregulatoryinvolved.

as the tina at which the actual activity of theThis means that the calibration data and timeaterials

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equal to that indicated on the label, should begenerator will behours beyond the time of shipment. no more thaa 48

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2.We will notify all NRC medical licann

Food and Drug Ad=iai=tration and offiefala of thmanufacturers and distributors, Agreement State authees, radiopharmaranticalorities, the-

Society, the American Collage of Naeleme Physi i! e Nuclear MnAietnaAmatican College of Nuelmar Medicina of suchc ans, and the

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than April 11, 1975. changes no~laterA copy of the notica is anclased.3.

Changes in labeling should be effected no lat1975.er than August 4,

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4.Advance calibration of other radiopharmaceutii

sidered on a case-by-case basia. cals will be con-i '

must justify their calibration procedures if theManufacturers and distributors.

'|time of receipt by the usar ascaede the acti i

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i activity atthe label by more than 20%.;) v ty indicated on.

] 5.These labeling proceduras are expected to be foll.I

by all manufacturers and di'stributors licensed by thhl owed uniformlyd

pursuant to Section 32.72 of 10 CFR Part 32. e NRCi-

We understand that the Radiopharmaceutical Co,

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f pursue the question of effecting changes in the Ummittee of the AIF willthe effective shelf life of radiopharmaceutiso that Commission labeling requirements can be met. S. Pharmacopoeia

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without reducingk cals.

'We feel that these changes are in thei

and appreciate the cooperation exhibited by the r die best interests of the public'E industry.

opharmaceuticala>

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i Sincerely,l!

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Original signed by 3 -

\Donald %. Nussbaumet

[iDonald A. Nussbaumer

Assistant Director for Materials.'

Agreements and TransportationgU

'| Division of Materials and I

Yuel Cycle Facility Licensing]2 Enclosure:Notification letteri

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