ML20140G326
| ML20140G326 | |
| Person / Time | |
|---|---|
| Issue date: | 09/15/1987 |
| From: | Miller V NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | Mallett B NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION III) |
| Shared Package | |
| ML20140G311 | List: |
| References | |
| NUDOCS 9706160148 | |
| Download: ML20140G326 (2) | |
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1 UNITED STATES g
NUCLEAR REGULATORY COMMISSION 8
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l MEMORANDUPi FOR:
Bruce S. Mallett, Ph.D., Chief i
Nuclear Materials Safety and Safeguards Branch Division of Radiation Safety and Safeguards, RIII FROM:
Yandy L. Miller, Chief Medical, Academic, and Comercial Use Safety Branch Division of Industrial and Medical Nuclear Safety, NHSS
SUBJECT:
LABELING OF IN VITRO DIAGNOSTIC TEST KITS PURSUANT TO TU IT D 2.71(c)
This is in reference to the August 18, 1987 l
your staff to Michael Lamastra of my staff. memorandum from Evelyn Matson of The issues raised in the memorandum have also been discussed by Ms. Matson with Bruce Carrico and Patricia Vacca of my staff.
We believe that the phrase " prepackaged unit" as it is used in 10 CFR 32.7 intended to mean the vial, bottle, test tube, or other final source container and is not intended to refer to 'he box or other outer sackaging that contains t
the kit components.
This interpretation is reasonable aecause it would ensure that a person handling a final. source container that had been separated from the outer packaging would still be alerted to the presence of radioactive material and to the identity, chemical fem and quantity of the radienuclide, and would be reminded that the material is "Not for Internal or E in Humans or Animals.'
Although we believe that there are many cases where the labeling require 10 CFR 32.71 c that there ma(y)be special situations in which all of the lab by the regulation cannot be placed on the fir.a1 source container (such as in the case of a very small vial).
exemptions pursuant to 10 CFR 30.11.These latter situations may be considered for explain why the label on the final source container cannot'contain all o t
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w information required by 10 CFR 32.71(c) and how and where they propose to provide the required information.
Applicants should be encouraged to use final CFR 32.71(c) as possible. source container labels that contain as much of the information to 10 CFR 32.71 that have a stock of existing labels may request au to use the existing labels for a reasonable period of time until new labels that fulfill the requirements of 10 CFR 32.71(c) can be printed.
Exemptions from the requirements of 10 CFR 32.71(c) should be coordinated with Headquarters in accordance with Policy and Guidance Directive FC B4-12 Revision.2, dated November 12, 1986.
We appreciate your bringing this matter to our attention and, by copy of this memorandum, are notifying the other Regions and the Agreement States of our views.
If you have any Lamastra (FTS 427-4093). questions on this matter, please contact Michael s
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- Miller, Fer dica, Academic, and Connercial Use Safety Branch Division of Industrial and e
Medical Nuclear Safety NMSS cc w/ copy of memo dtd 8/18/87:
J. Joyner, RI W. Cline, RII W. Fisher, RIY J. Montgomery RV
'.D. Mussbaumer,, GPA,
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