ML20141B220

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Matls Licensing Package for Amend 1 to License 50-29096-01MD for Alaska Radiological Pharmacy Ltd.Control:572434
ML20141B220
Person / Time
Site: 03034015
Issue date: 05/01/1997
From: Jonathan Montgomery
NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION IV)
To:
References
50-29096-01MD, 50-29096-1MD, 572434, NUDOCS 9705150187
Download: ML20141B220 (32)


See also: IR 05000290/1996001

Text

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FORM 374 U.S. NUCLEAR REGULATORY COMMISSION Amendment No. 1

MATERIALS LICENSE

Pursuant to the Atomic Energy Act of 1954, as amended, the Energy Reorganization Act of 1974 (Public Law 93-438), and g Title

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p Federci Regulations, Chapter I, Parts 30,31,32,33,34,35,36,39,40, and 70, and in reliance on statements and representations here [l

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by the licensee, a license is hereby issued authorizing the licensee to receive, acquire, possess, and transfer byprodu

mate 7ial designated below; to use such material for the purpose (s) and at the place (s) designated below; to delive

k persons authorized to receive it in accordance with the regulations of the applicable Part(s).This license shall be deemed to co

$ specified in Section 183 of the Atomic Energy Act of 1954, as amended, and is subject to all applicable rules, regulations, Rl

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3 Nuclear Regulatory Commission now or hereafter in effect and to any conditions specified below.

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Licensee In accordance with letter dated

November 21, 1996

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3. License Number 50-29096-01MD is amended in

1. Alaska Radiological Pharmacy Ltd. g

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2000 W. International Airport Road 4. Expiration Date April 30, 2001 E

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N A. Any byproduct material A. Unsealed A. Molybdenum-99 35.0 Ci k

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5 initially distributed Xenon-133 1.0 Ci

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s in accordance with a Strontium-89 495.0 mci E

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N pursuant to 10 CFR Rhenium-186 500.0 mci

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G. Any byproduct material G. Any sealed source G. 50 millicuries I

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p A. through E. PreparationanddistIibutionofradioactivedrugsand g

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Instrument calibration. Redistribution of sources to specifically authorized

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g~ SUPPLEMENTARY SHEET 030-34015 E

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y Amendment No. 1 E

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y 9. Authorized use (Continued): E

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g H. Redistribution of sealed sources as received from the manufacturer in the g

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i I. As shielding for molybdenum-99/ technetium-99m generators.

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Pursuant to 10 CFR 32.71, 32.72,'32.74, the licens,e"is e authorized to distribute g

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the byproduct material described in Items 6 and 7 a~nd Iirepared in accordance with g

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this license to persons licensed pursuant to Section 10,CFR 31.11, or Sections g

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equivalent Agreement State licenses. .;, g

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10. Licensed material'shall be used only at the licensee's facilifblocated at 2000 W. l

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11. A. Licensedmaterials'hallbeusN5y,~or'underthesupervis n of: l

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1) authorized nuclear pharmacists: Peter C.'Iverslie,lR.Ph.; E

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5 Steven C. Dragotakes, R.Ph.; Jeffery S. Cone, R.Ph.;

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2) a pharmacist working or designated as an authorized nuclear pharmacist E

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4 in accordance with 10 CFR 32.72(b)(2) and (4).,

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B B. The Radiation Safety Officer for this license is Peter Iverslie, R.Ph. E

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B 12. Sealed sources containing licensed material shall not be opened or sources removed E l

from source holders by the licensee.

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B 13. A. Sealed sources shall be tested for leakage and/or contamination at intervals E

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3 not to exceed 6 months or at such other intervals as specified by the E

R certificate of registration referred to in 10 CFR 32.210. E

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p B. Notwithstanding Paragraph A of this Condition, sealed sources designed to E

b. emit alpha particles shall be tested for leakage and/or contamination at E

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g 13. (Continued)

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C. In the absence of a certificate from a transferor indicating that a leak test g

has been made within 6 months prior to the transfer, a sealed source received g

from another person shall not be put into use until tested. g

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D. Sealed sources need not be leak tested if: g

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(i) they contain only hydrogen-3; or g

(ii) they contain only a radioactive gas; or l

(iii)the half-life of the isotope is 30 days or less; or l

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(iv) they contain not more than 100 microcuries of beta and/or gamma emitting .

material or not more than 10 microcuries of alpha emitting material; or l )

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(v) they are not designed to emit alpha particles, are in storage, and are -

! not being used. However, when they are removed from storage for use or

transferred to another person, and have not been tested within the E

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5 required leak test interval, they shall be tested before use or

transfer. No sealed source shall be stored for a period of more than 10

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W E. The leak test shall be capable of detecting the presence of 0.005 microcurie

W of radioactive material on the test sample. If the test reveals the presence E

9 of 0.005 microcurie or more of removable contamination, a report shall be E

B filed with the U.S. Nuclear Regulatory Commission in accordance with E

$ 10 CFR 30(b)(2), and the source shall be removed immediately from service and E,

$ decontaminated, repaired, or disposed of in accordance with Commission El

W regulations. The report shall be filed within 5 days of the date the leak E

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test result is known with the U.S. Nuclear Regulatory Commission, Region IV, E  !

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W 611 Ryan Plaza Drive, Suite 400, Arlington, Texas 76011, ATTN: Director, E

$ Division of Nuclear Materials Safety. The report shall specify the source E

N involved, the test results, and corrective action taken. E

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14. The licensee shall conduct a physical inventory every 6 months to account for all Ei

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g 17. The licensee is authorized to hold radioactive material with a physical half-life g

g of less than 65 days for decay-in-storage before disposal in ordinary trash g

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A. Radioactive waste to be disposed of in this manner shall be held for decay a l

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B. Before disposal as ordinary trash, byproduct material shall be surveyed at

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5 C. Generator columns shall.be segregated so that they may be monitored

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N D. A record of each disposal permitted under this License Condition shall be

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B 18. In addition to the p'ssession

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g -19. Except as specifically provided otherwise in this license, the licensee shall y

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procedures contained in the documents, including any enclosures, listed below. g

g The U.S. Nuclear Regulatory Commission's regulations shall govern unless the g

statements, representations, and procedures in the licensee's application and g

correspondence are more restrictive than the regulations. g

f A. Product labels submitted with application dated November 21, 1995

B. Application dated March 14, 1996 g

C. Letter dated March 25, 1996 E

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E. Facility diagram received April 2, 1996

f F. Letter dated November 21, 1996 N

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DIVISION OF ACCOUNTING AND FINANCE l

REQUEST FOR REFUND TO EMPLOYEE / VENDOR ]

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THE EMPLOYEE / VENDOR IDENTIFIED BELOW HAS OVERPAID THE NUCLEAR REGULATORY

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COMMISSION FOR GOODS AND/OR SERVICES PROVIDED AND IS DUE A REFUND

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TRANS TYPE: IR J08 CODE: ADCH AMOUNT:

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TRANS TYPE: it FUND: R1099 J08 CODE: _ FINE AMOUNT:

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UNITED STATES

t NUCLEAR REGULATORY COMMISSION

[ S REGION IV

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Walnut Creek Field Office

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Walnut Creek. California 94596-5368

NAY - 1 1997

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Alaska Radiological Pharmacy Ltd.

ATTN: Peter Iverslie

Radiation Safety Officer

2000 W. International Airport Road

Anchorage, Alaska 99502

SUBJECT: LICENSE AMENDMENT

Please find enclosed License No. 50-29096-01MD. You should review this license i

carefully and be sure that you understand all conditions. Regarding your request to add i

Vivian Foot to your license, we are unable to add her to your license until she has

completed the training requirements in 10 CFR Part 35 for a nuclear pharmacist. After she '

has completed her training, please submit a copy of her training records and refer to

control number 572434 and we, without an additional fee, will amend your license to list

Ms. Foot as an authorized nuclear pharmacist. If you have any questions, you may contact

Kent M. Prendergast at (510) 975-0255.

NRC expects licensees to conduct their programs with meticulous attention 4.3 detail and a

high standard of compliance. Because of the serious consequences to employees and the

1

public which can result from f ailure to comply with NRC requirements, you must conduct

your program involving radioactive materials in accordance with the conditions of your NRC

license, representations made in your license application, and NRC regulations. In

particular, note that you must:

1. Operate in accordance with NRC regulations 10 CFR Part 19, " Notices, instructions

and Reports to Workers: Inspection and Investigations," 10 CFR Part 20,

" Standards for Protection Against Radiation," and other applicable regulations.

2. Possess radioactive material only in the quantity and form indicated in your license.

3. Use radioactive material only for the purpose (s) indicated in your license.

4. Notify NRC in writing of any change in mailing address (no fee required if the

location of radioactive material remains the same).

.

5. Request and obtain written NRC consent before transferring your license or any

right thereunder, either voluntarily or involuntarily, directly or indirectly, through

transfer of control of your license to any person or entity. A transfer of control of

your license includes not only a total change of ownership, but also a change in the

controlling interest in your company whether it is a corporation, partnership, or

_ _ - _ . _ - . _ _ _ - _ _ - -

-- . - . .

k

e

Alaska Radiological Pharmacy -2-

(continued)

other entity. In addition, appropriate license amendments must be requested and

obtained for any other planned changes in your facility or program that are contrary

to your license or contrary to representations made in your license application, as

well as supplemental correspondence thereto, which are incorporated into your

license. A license fee may be charged for the amendments if you are not in a fee-

exempt category.

6. Maintain in a single document decommissioning records that have been certified for

completeness and accuracy listing all the following items applicable to the license:

  • Onsite areas designated or formerly designated as restricted areas as defined

- in 10 CFR 20.3(a)(14) or 20.1003.

  • Onsite areas, other than restricted areas, where radioactive materials in  !

quantities greater than amounts listed in Appendix C to 10 CFR

20.1001-20.2401 have been used, possessed, or stored.

  • Onsite areas, other than restricted areas, where spills or other unusual

occurrences involving the spread of contamination in and around the f acility,

equipment, or site have occurred that required reporting pursuant to 10 CFR

30.50(b)(1) or (b)(4), including areas where subsequent cleanup procedures

have removed the contamination.

  • Specific locations and radionuclide contents of previous and current burial

areas within the site, excluding radioactive material with half-lives of 10 days

or less, depleted uranium used only for shielding or as penetrators in unused

munitions, or sealed sources authorized for use at temporary job sites.

I

  • Location and description of all contaminated equipment involved in licensed

operations that is to remain onsite after license termination.

.

7. Submit a complete renewal application with proper fee, or termination request at

least 30 days before the expiration date on your license. You will receive a

, reminder notice approximately 90 days before the expiration date. Possession of

radioactive material after your license expires is a violation of NRC regulations.

8. Request termination of your license if you plan to permanently discontinue activities

involving radioactive material.

.

. . ._ _

-. --- .- ._. .. -. . .- -- .-

.

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Alaska Radiological Pharmacy 3

You will be periodically inspected by NRC. Failure to conduct your program in accordance

with NRC regulations, license conditions, and representations made in your license

application and supplemental correspondence with NRC will result in enforcement action

against you. This could include issuance of a notice of violation; imposition of a civil

penalty; or an order suspending, modifying, oi revoking your license as specified in the

" General Statement of Policy and Procedure for NRC Enforcement Actions" (Enforcement

Policy), 60 FR 34381, June 30,1995.

Thank you for your cooperation.

Sincerely,

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P "' ' [.

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Beth A. Prange l

Sr. Health Phy cist (Licensing) l

Materials Branch

Docket: 030 34015

License: 50-29096-01 MD

Control: 572434

Enclosures: As stated

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DOCUMENT NAME: G:\AKRAD 572434 i

. To receive copy of document, indicate in box: "C" = Copy without enclosures "E" = Copy with enclosures "N" = No copy .l

RIV:MB l RIV;>tB l l l l  !

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04/11/1997 13:33 9072434570 N:p PAGE 01

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ALASKA RADIOLOGICAL PHARMACY, LTo.

. . . 2000 W. Int'l Airport Rd., Suite All, Anchorage, AK 99502

  • (907) 243-6377 Fax (907) 243-4570

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U.S. NUCLEAR REGULATORY COMMISSION DATE:2/5/97 lIl

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TIME: 1:00P l

TELEPHONE OR VERBAL CONVERSATION RECORD am or pm-

INCOMING CALL- OUTGOING CALL VISIT

PERSON CALLING ADDRESS PHONE # / EXTENSION

Kcut krendergast RIVi WCFO (510)975 - 0255

PERSON CALLED: ADDRESS: PHONE # / EXTENSION:

Peter Iverslie Alaska Radiopharmacy (907) 243-6377

I I I

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CONVERSATION

SUBJECT: License Amendment

SUMMARY: We discussed the recent request for amendment and I requested

that Mr. Iverslie provide me the following. ,

1)f Surveys and wipe tests of the area in the former resticted area to ensure  ;

there is no residual contamination. j

2) a certificate, license or other documentation on Vivian Foot to document- i

that she has-completed the training in. 35.980 and evidence of continueing

education'aince her last training was in 1986 which exceeds the seven years '

.

listed in 35.972.

t

REFERRED TO: MS-15 ADVISE ME OF

ACTION TAKEN ,

ACTION REQUESTED. (Y) OR (N)  !

Provide information ,

INITIALS: KP

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DATE

ACTION TAKEN INITIALS:

1

DATE

NRC FORM 218 ,

REPO (2-89;KMP) .

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NUCLEAR REGULATORY COMMISSION

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/ Walnut Creek Field Office

1450 Maria lane

Walnut Creek, California 94596-5368

DEC - 3 1516

Peter lverslie,' RPh.

President

Alaska Radiological Pharmacy, Ltd.

2000 W. International Airport Road

Suite A11

' Anchorage, Alaska 99502

SUBJECT: ACKNOWLEDGMENT OF REQUEST FOR LICENSING ACTION

REFERENCE: Letter datei November 21,1996

LWe have completed the administrative review and initial processing of your application.

Please note that the technical review may identify additional omissions in the submitted

information or technical issues that require additional information.

Amendment actions are normally processed within 90 days, unless the technical review

identifies:

  • Major technical deficiencies
  • Policy issues that require input and coordination with other NRC Regional offices,

Agreement State offices, or NRC's Office of Nuclear Materials and Safeguards

A copy of your correspondence has been forwarded to our License Fee and Accounts

Receivable Branch, Office of the Controller, who will contact you separately if the

appropriate license fee has not been submitted for your request, or for billing if your

request is subject to full cost recovery.

Any correspondence about this application should reference the Control number listed

below.

Sincerely,

c

0- 4

Beth Prange

Sr. Health Physicist (Licensing)

Materials Branch

E Docket No. 030 34015

License No. 50-29096-01

.

. Control _ No..572434

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Anchorage, Alaska i

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Docket File

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To receive a copy of this document, indicate in the box "C" - Copy without

' attachment / enclosure "E" - Copy with attachment / enclosure "N" - No Copy

OFFICE. RIV:AO:NMLB N N- i

NAME J.' Garcia h B. Prange See  ;

DATE h / h/96 k /2J3/ 96 -

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ALASKA RADIOLOGICAL PHARMACY, LTD.

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(:L : ( (907) 243-6377 + Fax (907) 243-4570 g g

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November 21,1996

Radioactive Materials Safety Branch

U.S. Nuclear Regulatory Commission, Region V

1450 ~wana Lane

Walnut Creek. CA >4596-5368

'

ATTN: Beth Prange

Dear Beth Prange:

Please find enclosed two copies of the addendum to our materials license #50-29096-

OlMD The first is a floor plan of the pharmacy (ATT 1.1) which shows the reduction in

the restricted area. The back two rooms now contain the same equipment that use to be in

the old restricted area. A copy of the new lay out is being sent to the Fire Department.

The second is the addition of two nuclear pharmacists to the license. The first Pharmacist

is Yunga Vercelline (Chang was her madden name). She worked for Syncor in Maryland.

I have enclosed her documentation. IIer Alaska Pharmacy License number is 1126. The

second Pharmacist is Vivian Foote. She could not locate her documentation but was on

staff as a nuclear pharmacist at Syncor in Blue Ash, Ohio from 1986 to 1988. IIer Alaska

Pharmacy License number is 1120. If there are any questions please do not hesitate to call

me at (907) 243-6377.

~

Sincerely,

./ j j <

Peter iverslie,IU)h.

President

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FIGURE 2. DOCUMENTING RADIOISOTOPE HANDUNG EXPERIENCE  ;

1

Name: Yunca Chana APh

EXPERIENCE WITH RADIOACTIVE MATERIAL (Actual Use of Radioisotopes Under the Supervision of an

Authonzed User)

ISOTOPE MAXIMUM WHERE EXJf.'AlENCE DURATION OF TYPE OF l

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2 Cl Syncor International Corporation 05/12/93 thru 07/09/93 1,6 ]

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decontamination procedures, surveys and wipe tests. i

6. Elution of Technetium-99m generator systems, assay and testing of the elute for Molybdenum 99

contamination, and processing the eiute with reagent kits to prepare Technetium-99m labeled

radiopnarmaceuticals.

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l . .I 'l ALASKA RADIOLOGICAL PHARMACY, LTD.  !

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[ 2000 W. Int'l Airport Rd., Suite All, Anchorage, AK 99502

. 9, x. .;),y ! - (907) 243-6377 * Fax (907) 243-4570  ;

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November 21,1996

Radioactive Materials Safety Branch

U.S. Nuclear Regulatory Commission, Region V

.1450 Maria Lane

Walnut Creek, CA 94596-5368

ATTN: Beth Prange

Dear Beth Prange:

4

Please find enclosed two copies of the addendum to our materials license #50-29096-

OlMD.- The first is a floor plan of the pharmacy (ATT 1.1) which shows the reduction in

the restricted area. The back two rooms now contain the same equipment that use to be in

the old restricted area A copy of the new lay out is being sent to the Fire Department.

The second is the addition of two nuclear pharmacists to the license. The first Pharmacist

is Yunga Vercelline (Chang was her madden name). She worked for Syncor in Maryland.

I have enciased her documentation. Her Alaska Pharmacy License number is 1126. The

second Phannacist is Vivian Foote. She could not locate her documentation but was on

staff as a nuclear pharmacist at Syncor in Blue Ash, Ohio from 1986 to 1988. Her Alaska

Phannacy License number is 1120. If there are any questions please do not hesitate to call

me at (907) 243-6377.

Sincerely

/s-

- _.

ter Iverslic,RPh.

President

enclosure

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FIGURE 2, DOCUMENTING RADIOISOTOPE HANDLING EXPERIENCE

Name: Yunca Chana PPh

EXFERIENCE WITH RADIOACTIVE MATERIAL (Actual Use of Radioisotopes Under the Supervision of an

Authorized User)

ISOTOPE MAXIMUM WHERE EXPERIENCE DURATION OF TYPE OF l

AMOUNT WAS GAINED EXPERIENCE USE

USED AT (actual clock 1.2.3,4,5,6

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Mo-99 3 Ci

Syncor International Corporation 1,6

Tc.99m 2 Ci 05/12/93 thru 07/09/93

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The number or numbers entered under " Type of Uso" correspond to expe ience in the following activities. .

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radiation surveys. l

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