ML20210Q383
| ML20210Q383 | |
| Person / Time | |
|---|---|
| Issue date: | 02/27/1975 |
| From: | Struttman L NRC |
| To: | NRC |
| Shared Package | |
| ML20150F580 | List: |
| References | |
| NUDOCS 8610060936 | |
| Download: ML20210Q383 (2) | |
Text
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i, t ,
TRIP REPORT
)
VISITED: Leo Wade, Jr., USNRC, Washington, D.C.
BY: Lloyd G. Struttman DATE: 2:00 p.m. February 27, 1975
SUBJECT:
Meeting of USNRC and Radiopharmaceutical Manufacturers' Representatives on the Proposed Labeling Changes Under Group Licensing REPRESENTING USNRC: REPRESENTING R/P Manufacturers:
Messrs: Howard J. Larson Drs: J. Calvin Brantley, Donald Nussbaumer New England Nuclear Bernard Singer Gerald A. Bruno, Wayne Kerr E. R. Squibb & Sons Charles Kroll, Dr: Leo Wade, Jr. E. R. Squibb & Sons Messrs: Frederich Fuest, Medi-Physics Chase Lichtenstein, Medi-Physics Ms: Joan Kurjian,
) Abbott Laboratories The meeting was held in the Maryland National Bank Building, Old Georgetown Road, Bethesda, Maryland.
There was a general review of the problems that would result if this radical departure from the current labeling practices were imposed on manufacturers. These considerations are specified in the attached agenda and the USP and AIF letters.
We requested that only Tc 99m generators be considered for this change, and for them to make the assay date 2 days later than
, the earliest shipping date. In addition, if the generator is the only product affected, or if the total line is, it was ex-pressed that a minimum of four months time would be needed to e f fect the change . Finally, if any changes are made, the USNRC should inform the user physicians of these changes in such a manner so as to make-.it clear that it was a regulatory imposed change.
Dr. Wade and his superiors are going to take these requests under advisement. They will inform us of what changes they will finally require. In the meantime we (Mallinckrodt) can maintain a valid distributors Group License by submitting a request by 8610060936 850B16 REC 3 LIC30 24-04206-05MD PDR 13 JAN tms
TRIP REPORT
) USNRC 2/27/75 letter to extend our license beyond the March 31, 1975 expira- .
tion date. This letter was submitted on February 28, 1975.
This will be considered as having been filed at least 30 days in advance of the expiration date, and by their rule the license will be extended beyond the expiration date until such time as the USNRC has taken administrative action.. So for now it is business as usual until we are notified of the changes we must make in labeling; and, hopefully, we will get at least four months to make them.
J 2 &- -
Lloyd G. Struttman LGS /km Attachments cc w/attch: R. J. Bever R. C. Bousquet" i N. E. Drissell E. L. Holmes F. P. Halle tt W. P. Robb D. W. Soldan T. W. Tusing 14 JAN 19 9 ;
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