ML20198J224

Informs That Ocfo Reviewed & Concurs W/Draft Commission Paper on Proposed Rule, Exempt Distribution & Use of Radioactive Drug Containing One Uci of C-14 Urea (Parts 30 & 32)

ML20198J224
Person / Time
Issue date:	03/12/1997
From:	Heavey T NRC
To:	Steve Jones NRC
Shared Package
ML20013E023	List: ML20198H571 ML20198H672 ML20198H718 ML20198H780 ML20198H830 ML20198H875 ML20198H887 ML20198H907 ML20198J119 ML20198J157 ML20198J188 ML20198J224 ML20198J252 ML20198J270 ML20198J298 ML20198J324 ML20198J404 ML20198J418 ML20198J664 ML20198J741 ML20198J766 ML20198J793 ML20198J830 ML20198J869 ML20198J932 ML20198J978 ML20198J988 ML20198J995 ML20198K019 ML20198K055 ML20198K065 ML20198K118 ML20198K151 ML20198K202 ML20198K217
References
FRN-62FR32552, RULE-PR-30, RULE-PR-32 AF70-1-042, AF70-1-42, NUDOCS 9801140072
Download: ML20198J224 (1)

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6F 70-/ t PDL i From: Thomas Heavey f' To TWP9.SEJ Dates 3/12/97 6:46pm Subject PROPOSED RULE: EXEMPT DISTRIBUTION... CARBON.14 UREA OCFO has reviewed the draft Commission Paper, subject: Procosed Rulei. Exemot ,

Qistribution and Use of a Radioactive Druo containino One Microcurie of_

Carbbon 1{ Urea (Partsl0 and 32), and concurs.-

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TERRY E. SRANST AD. GovtRNon DEPARTMENT OF PUBLIC HEALTH /

CHRISTOPHEN G. ATCHISON.OsmtCtom March 11,1997

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Lloyd A. Bolling United States Nuclear Regulatory Commission e

Office of State Programs Washington, D.C. 20555-0001 y

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Dear Mr. Bolling:

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SUBJECT:

9 SP 97-015 RULEMA}UNO PLAN 10 CFR PARTS 30 AND 32 CARBg.14 UREA H. PYLORI DIAGNOSTIC TEST This letter is in response to your All Agreement States letter date:d March 7,1997. The following is the Iowa Department of Public Health's position on the two questions asked:

1. What is Iowa's position on the NRC's plan not to limit receipt of C 14 Urca H. Pylori to physicians, but to rely on FDA and State Boards of Pharmacy to decide who can administer the drug?

After examining the NRC technical evaluations, the State oflowa agrees with the NRC's position to grant the petition. We recommend permitting the distribution of C 14 Urea H. Pylori to phy sicians who are not authorized users provided that the distributor has a specific license to distribute the radiopharmaceutical, The radiopharmaceuticalin exempt quantities does not, in our opinion, pose a significant enough threat to public health and safety to require the recipient to be generally or specifically licensed. Funhermore, to generally license this radiopharmaceutical will cause unwarranted burden on the State Regulatory Agency and distributor due to reports required under existing regulations. The Iowa Department of Public Health will rely on FDA and State Board of Pharmacy to decide who can administer the drug.

2. Are Iowa's requirements, mandated by regulations other than the radiation control program regulations, of concern if the capsules are authorized under an exempt distribution license, with a Division I level of compatibility for the users?

S A-4 LUCAS STATE OFFICE BUILDING / DES MOfNES. lOWA 503190075 / 515 2815787 n':Ya>N2 ? y. FAX/ # (515) 2814958 / TDD-DEAF SERVICES #t515) 242 6156 gp (jD wigz1ex

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4 Page 2, Bolling,Lloyd A.

. USNRC, Office of State Programs .

March 11,1997 Cwrently there are no regulations in the State oflows that would be of concern if capsules are authorized under a specific license to distribute exempt quantities, provided that the drug meets FDA appmval.-

If you have any questions conceming this matter do not hesitate to contact Mark L Flickinger at(515)242 6281 or me.

Sincerely,

[M Donald A. Flater, Chief i Bureau of Radiological Health

-(515)281 3478-gif/DAF

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