Text

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)
	v • d • e

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FORM 374

U.S. NUCLEAR REGULATORY COMMISSION

Amendment No. 1

MATERIALS LICENSE

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

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

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

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

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

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

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

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Licensee

In accordance with letter dated

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November 21, 1996

3. License Number

50-29096-01MD is amended in

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Alaska Radiological Pharmacy Ltd.

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its entirety to read as follows:

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2000 W. International Airport Road

4. Expiration Date

April 30, 2001

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Suite A-11

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Anchorage, Alaska 99502

5. Docket or

030-34015

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Reference No.-

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6. Byproduct, Source, and/or

7. Chemical and'or Physical

8. Maximum Amount that Licensee

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Special Nuclear Material

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May Possess at Any One Time

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Any byproduct material

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initially distributed

Xenon-133

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in accordance with a

Strontium-89 495.0 mci

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specific license issued-

Phosphorus-32 50.0 mci

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pursuant to 10 CFR

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Any byproduct material

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listed in 10 CFR

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Amendment N9. 1

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redistribution of Mo99/Tc99m generators to authorized

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recipients.

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Redistribution to specific licensees or general licensees pursuant to 10 CFR

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31.11 provided the packaging and labeling remain unchanged.

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Instrument calibration.

Redistribution of sources to specifically authorized

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recipients.

Pursuant to 10 CFR 32.74, the licensee is authorized to

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redistribute sources to persons licensed pursuant to 10 CFR 35.57(a) or under

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U.S. NUCLEAR RETULATORY COMMISSloN

PAGE 3

OF 6

PAGES

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License Number

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50-29096-01MD

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MATERIALS LICENSE

Docket or Reference Number

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SUPPLEMENTARY SHEET

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Amendment No. 1

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Authorized use (Continued):

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Redistribution of sealed sources as received from the manufacturer in the

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manufacturer's original packaging and shielding and accompanied by the

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manufacturer's approved instructions to authorized recipients for use and

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storage,

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

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the licens,e"is authorized to distribute

Pursuant to 10 CFR 32.71, 32.72,'32.74,

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

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

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35.57, 35.100, 35.200, 35.300, 35.400, and 35.500 of 10 CFR1Part 35, or under

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equivalent Agreement State licenses.

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CONDITIONS

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10.

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

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International Airport Road, Suite, A-11, ~ Anchorage,; Alaska.

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11.

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Licensedmaterials'hallbeusN5y,~or'underthesupervis n of:

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authorized nuclear pharmacists:

Peter C.'Iverslie,lR.Ph.;

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

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Kathleen M. Taylor, R.Ph.; or Ronald J. Callahan, R.Ph.; Yunga

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Vercelline, R.Ph.

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a pharmacist working or designated as an authorized nuclear pharmacist

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

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

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12.

Sealed sources containing licensed material shall not be opened or sources removed

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from source holders by the licensee.

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13.

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Sealed sources shall be tested for leakage and/or contamination at intervals

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

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certificate of registration referred to in 10 CFR 32.210.

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Notwithstanding Paragraph A of this Condition, sealed sources designed to

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

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intervals not to exceed 3 months.

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FORM 374A

U.S. NUCLEAR REOULAToRY COMM:SSION

PAGE

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OF

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License Number

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50-29096-01MD

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MATERIALS LICENSE

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SUPPLEMENTARY SHEET

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Amendment No. I

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C.

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

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

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

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D.

Sealed sources need not be leak tested if:

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(i) they contain only hydrogen-3; or

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(ii) they contain only a radioactive gas; or

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

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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

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

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

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

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

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transfer.

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

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years without being tested for leakage and/or contamination.

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

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of radioactive material on the test sample.

If the test reveals the presence

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

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

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

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decontaminated, repaired, or disposed of in accordance with Commission

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

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

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

Director,

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

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involved, the test results, and corrective action taken.

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Tests for leakage and/or contamination shall be performed by the licensee or

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by other persons specifically licensed by the Commission or an Agreement

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State to perform such services.

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

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sources and/or devices received and possessed under the license.

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15. The licensee is authorized to transport licensed material only in accordance with

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the provisions of 10 CFR Part 71, " Packaging and Transportation of Radioactive

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Radioactive waste may be picked up from the licensee's customers and disposed of

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in accordance with the procedures, statements, and representations in application-

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dated March 14, 1996.

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

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

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provided:

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

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minimum of 10 half-lives.

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the container surface with the appropriate meter set on its most sensitive

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scale and with no interposed shielding to determine that its radioactivity

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cannot be distinguished from background.

All radiation labels shall be

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

separately to ensure decay to background levels prior to disposal.

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

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retained for 3 years. The record must. include the date of disposal, the date

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on which the byproduct material was placed in storage, the radionuclides

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disposed, the survey instrument used,.the background dose rate, the dose rate

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measured at the surface of each waste container, and the name of the

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individual who performed the disposal.

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In addition to the p'ssession limits in Item 8, the licensee shall further

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restrict the possession of licensed material to quantities below the minimum limit

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specified in 10 CFR 30.35(d) and 40.36(b) for establishing decommissioning

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Amendment No. 1

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Except as specifically provided otherwise in this license, the licensee shall

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conduct its program in accordance with the statements, representations, and

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

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

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correspondence are more restrictive than the regulations.

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Product labels submitted with application dated November 21, 1995

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Application dated March 14, 1996

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Letter dated March 25, 1996

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UNITED STATES

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NUCLEAR REGULATORY COMMISSION

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REGION IV

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Walnut Creek Field Office

1450 Maria Lane

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

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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

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

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Alaska Radiological Pharmacy

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(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.

.

. .

._

_

-.

---

.-

._. ..

-.

.

.-

--

.-

.

o

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,

fh

P "' ' [.

-

,-

Beth A. Prange

Sr. Health Phy cist (Licensing)

Materials Branch

Docket: 030 34015

License: 50-29096-01 MD

Control: 572434

Enclosures: As stated

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INCOMING CALL-

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PHONE # / EXTENSION

Kcut krendergast

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PERSON CALLED:

ADDRESS:

PHONE # / EXTENSION:

Peter Iverslie

Alaska Radiopharmacy

(907) 243-6377

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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-

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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.

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REFERRED TO: MS-15

ADVISE ME OF

ACTION TAKEN

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(Y) OR (N)

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DATE

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NRC FORM 218

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REPO (2-89;KMP)

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NUCLEAR REGULATORY COMMISSION

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Walnut Creek Field Office

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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-

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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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OFFICE.

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(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 ~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.

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Sincerely,

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Peter iverslie,IU)h.

President

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FIGURE 9-2

FIGURE 2. DOCUMENTING RADIOISOTOPE HANDUNG EXPERIENCE

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

AMOUNT

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Syncor International Corporation

05/12/93 thru 07/09/93

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Timonium. Maryiand

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Key for ' Type of Use"

,

The number or numbers entered under " Type of Use" correspond to exponence in the following activt:les:

1.

Ordering, receiving, and unpacking radioactive materials safety, inc!uding perforrnance of related

radiation surveys,

2.

Calibration of dose calibrator, scintilation detectors, and survey meters.

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!

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ALASKA RADIOLOGICAL PHARMACY, LTD.

1

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

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. 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 9-2

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

ONE TIME

hours)

(see key

below)

Mo-99

3 Ci

Tc.99m

2 Ci

Syncor International Corporation

05/12/93 thru 07/09/93

1,6

l131

150 mci

Timonium, Maryland

344 Ho irs

3,4,5,6

Xe-133

1 Cl

1,4,5

l123

1 mCl

08/02/93 thru 08/27/93

1,3,4,5

l125

100 UCI

120 Hours

1,3,4,5

Ga67

100 MCI

1.3.4.5

TI201

10 mCl

09/20/93 thru 09/25/93

1,3,4,5

'n 111

500 mci

40 Hours

1,3,4,5

Co-57 -

5 MCI

1,3,4,5

Cs-137

250'uCl

504 Total Hours

2

Sa 133

250 uCI

2

t

i

Key for ivos of Use'

.

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

.

s

i

Ordering receiving, and unpacking radioactive materials safety, including performance of related

1.

radiation surveys.

2.

Calibration of cose calibrator, scintilation detectors, and survey meters.

t

3.

Calculation. dispensing, and calibration of patient doses, including proper use of radiation shields.

4.

Appropriate internal control procedures to prevent mislabeling errors

\\

5.

Emergency procecures to handle and contain spilled materia's safely, inc!uding related

j

decontamination procedures, surveys and wipe tests.

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

6.

contam, nation, and processing the eiuto with reagent kits to prepare Techrtetium-99m fabeled

l

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J'dN- B-95 SAI 8:33 AM

YA',!.E'l HOS?!TAL FHAEMACY

F AX NO.

907 746 8731

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