ML20210M598

License 34-13993-01 for O'Bleness Memorial Hosp,Authorizing Use of 100 Mci I-131,500 Mci Mo-99,1 Mci I-125 or I-131 (as Triiodothyronine or Thyroxine) & 100 Mci Tc 99m Sulfur Colloid for Diagnosis,Treatment,In Vitro Study & Imaging

ML20210M598
Person / Time
Issue date:	04/23/1971
From:	Bowyer J NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS)
To:
Shared Package
ML20210M559	List: ML20210M598
References
34-13993-01, 34-13993-1, NUDOCS 8610030471
Download: ML20210M598 (3)

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' @ ronu'acc.374 cm.3 U. 5. ATOMIC ENERGY COMMISSION Pag 25

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io an so BYPRODUCT MATERIAL LICENSE i / (Medical . Greeps 1 & 11)

LUrLLCTIE QQl.f-Pursuant to the Atomic Energy Act of 1954 and Title 10, Code et Federal Regulations, Chapter 1, Parts 30, 32,33, l

1 34, and 35, and in reliance on statements and representations heretofore made by the licensee, a license is hereby issued I authorizing the hcensee to receive, acquire, own, possess, transfer and import byproduct material listed below; and to use such byproduct material for the purpose (s) and at the place (s) designated below. This licenso sh311 be deemed to contain t'n e l conditions specified in Section 183 of the Atornic Encrgy Act of 1954 as amended, and is subject to all applicable rules, rcg.

ulations, and orders of the Atomic Energy Commission n r hereafter in effect and to any conditions specified below.

Licensoo YI 6 ~

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i 1. O' Eloneas Ha.norial Hospital ' I JW' l P3. tjcense Number 34-13993 01 l

2. Fospitel trivo I / J

t. thens, chio 4570f Il 14 Empiration date '4I U #d s M.0

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5. Referenco No.

6. Byproduct material A.J.hern1 cal and/or physical E. Maximum amount of radioac.

(clement and mass numbor) form tivity which licensco may possess at any one fimo A. Any byproduct . A. ,Any radio. .

A. As necessary material listed pharmaceutical for uses in Groups I and listed in Groups authorized in ll of Schedule A, I and ll of Subitem 9. A..

Section 35.100 Scheduto A, of 10 CFR 35 -

Soction 35.100 of 10 CFR 35 ,

B. Indtne 131 r x i' D. Iodido D. 100 clllicaties C. Molybdena.a 99 C. ::olybdonuts 99/ c. 503 attlicacles Iechnetluro W.a Genorntar (S. h. '.;quibb anc Sons Model Ho. 06J71;

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. - : 6 V bbbott L.0bn. Model i.o. "-

7721; C . theresec,uticals Model ;.o n. ..u -011, i..la -Jd2, t.iu-dO3, and :Ri-Ud4; Mallinchodt Che". Lcci Works .

iodel hos. 5543 t.hroash 5542; t;nllinchrodt Chemical Works F.odel :.o n. G Jt' threugh 009; Cambridne nuclear Corp. 1odel

o. C.-4 201; n nd 1.*ac r nha.a/

Scarlo Corporation c.cdol Ho s . C IC- 5 J , u sC-lGO , GIc-200, GIC-300.nt/

printed onThe a -4J0 ' s.de reve)rso o_f th.is page shall apply to Condit. ions numborod! , 2, 3, 4 i this licenso. i s L. G t. I V L. L t ' '

APR 2 819G3 s.

REGION III -

8610030471 860728 #

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• REG 3 LIC30 34-20249-01 pnn

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. . /, ,, ,o Page 2 of 2 Pa;;e4 ra U. S. ATO311C ENEltGY COM311SSION

' ?. .' BYPitODUCT MATEIIIAL LICENSE Supplementary Sheet

.nued From Page I License Number M* I "N L'JillCME COPY

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6. Byproduct material 7. Chemical and/or physical form 8. Maximum amount of radioactivity whici:

licensee may possess at any one time

. (element and mass number)

? D. Iodine 125 or 131 D. Triiodothyronios D. I mLilicurie

1. ' and/or lhyror.ine

! E. Technetium 993 E. Sulfur colloid E. 100 militcuriec

Ureparod by the licensea ustn3 the Squibb or Abbott Kit) l

9. Authorized use A. Any diar,nostic procedure tiered in Croups I and LI of Schedule A, l' Section 35.130 of Titie 10, Codo of iederal Ec;;ulations.

B. Treatnant of hyperthyroidism, cardiac dystunction, and thyroid cercinoma.

C. Froduction of Technetiuss 99m Fertechnetate. -

D* .lD .61E2 studies.

E. Liver and spicon 1:naging.

10. Lyproduct material shall be used by, or undar the supervision of, E. H. Ctanley, M.D. typroduct marcrist Linted as Subite:a D. may also be used by, or under .the supervision of. Jon D. wens, Jr., M.b.

11. l'ctients containing lodina 131 ior the treatment of thyroid

- carcinosa nhail remain hospitalired until the residual cctivity is 30 millicuries or loss.

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! 12. A. Technatius 99m Portechnatato nay be cluted and prepared from

! a Holybdonum 99/Tachnetiua 99m generator in accordance with i state:aents, reprenaarations, and ;racedoros contained in i application cr.ted iebruary 27, 1971 and Lettor dated /sril 15, 1971, signed by Er. C.11. Stanley.

B. Technetium 99:a tabeled sulfur colloid prnpr. rations which appear flocculent or af&regated shall not be used in humans.

! C. Technotina 99a labated cultur colloid shall be procured

! and/or ire;:nrad in accordance uith statemnts, reyresentations l and procedures contained in oppilcation dated february 27,197I.

I For the U. S. Atomic Energy Commission I

i Origir.al Signed b) l Date D33E fehn E. Bowyer by " **ria1a 7-n1ew Di.mson of Materials Licensing 1

Washtaston. D C. 20545 I

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i - 1. Byproduct material may only be used at the licensee';s address stated in item 2 above, i "

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~2. Tht licensee shall comply with the provisions of Title 10, Chapter 1, Code of Federal . 6- p Reculations, Part 20, " Standards for Protection Against Radiation." - 9 a

i 3. I:xcept as otherwis'e specifically provided by this license, byproduct material to be~ad- T*

ministered to humans shall be procured in prepackaged, precalibrated form from a supplier who manufactures or repackages the product under appropriate pharmaceutical controls e related to assay, identity, quality, purity, sterility, and nonpyrogenicity.

4. lodine l'31 labeled Macroaggregated lodinated Human Serum Albumin, Chromium 51 i

labeled Human Serum Albumin, and lodine 131 labeled Colloidal (Microaggregated) --

Human Serum Albumin shall be procured from a supplier who holds an unsuspended or' ^ ' -

unrevoked license issued by the Secretary, Department of Health, Education, and Welfare, to propagate or manufacture and prepare, label, or distribute this material pursuant to Title 42', Chapter 1, Code of Federal Regulations, Part 73, " Biological Products." - ,

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5. Needles or standard medical applicator cells containing Cobalt 60 as wire siiali not be, opened by the licensee unless specifically authorized by a condition in this license. .

6. Patients containing Cobalt 60, Cesium 137, and/or Iridium 192 implants shall remain hospitalized until the implants are removed. -

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, 7. Patients containing lodine 131 for the' treatment of thyroid carcinoma or patients con-taining therapeutic quantities of Gold 198 shall remain hospitalized until the residual activityis 30 millicuries or less.

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