iba molecular north america, inc., additional request ... · received 10/;7/2+3@7 11:37 7037874079...

October 19,2007

US. Nuclear Regulatory Commission, Region I Division of Nuclear Materials Safety 475 Allendale Road King of Prussia, PA 19406-1415

RE: License No. 45-25221-01 MD - Item 11B

Dear Sir: IBA Molecular North America, Inc. would like to amend the aforementioned license. Please add the following as Authorized Nuclear Pharmacist - Item #I 1 B - credentials enclosed:

Amendment Request to Add Authorized Nuclear Pharmacists

Kim, Hijin Angela, Pharm.D. IBA Cover Letter, Form 313A. IBA Experience Grids, signed by Jamie Perry at Somerset, one signed by Nasrin Pourkiani at Sterling, Ohio State ANP Didactic Certificate, Ohio State Didactic Grid, Ohio State Experience Grid, and State of New Jersey Pharmacist Permit.

Form 313A, Empire Isotopes Letter and Preceptor's BCNP, ANP application to NY BOP, Ohio State ANP Training Certificate, University of New York Pharmacist Certificate, and State of New York

Lewis, Thomas, R.Ph. \

'c\ Pharmacist Permit. \' Lough Ronald, R.Ph. ('post dated 10/25/07) Cover letter from Preceptor*, Form 313A*, Ohio State ANP Didactic Certificate, Ohio State Didactic Grid, Ohio State Experience Grid and State of West Virginia Pharmacist Permit

IBA Preceptor Cover Letter, Cardinal Health Preceptor Statement, Syncor ANP Didactic Grid, Snycor Experience Grid, Syncor Training Statement, and Commonwealth of Massachusetts Pharmacist Permit.

IBA Preceptor Cover Letter, Syncor AU Didactic Letter 3 pages, Syncor Didactic Grid, Syncor Experience Grid, Butler University Nuclear Pharmacy AU Program Certificate, University of New York Pharmacist Certificate, and State of New York Pharmacist Permit.

Form 313A, Purdue University Nuclear Pharmacy Didactic Diploma, IBA Experience Grid, and State of Illinois Pharmacist Permit.

Oliveira, Steven, R.Ph. 9% qy 8 Samuel, Ernesto, R.Ph. lb

Young, Derick, R.Ph.

All other RAM License conditions of the license remain in effect. Thank you. If you have any questions about this amendment request, please contact me at the number on the stationary or on my cell phone. Or for quick questions and correspondence please contact my assistant Jim Kostka at his cell 202 207-5437.

Thank you.

Sincerely, Duann Vadersfice

Duann Vanderslice, RPh, BCNP, FAPhA Corporate RSO, IBA Molecular North America, Inc. Cell (304) 21 5-351 2

le /a % 0 NMSSIRGNI MATERlALS-o@

First name CommonlMiddle Name Last name

Hijin (Angela) Kim, Pharm D. IBA Cover Letter NRC Form 313A(ANP) IBA Experience Grid - signed by Jamieisomerset

IBA Experience Grid - signed by NasrinlSterling

Ohio State Univ ANP Training Certificate Ohio State Univ Didactic Grid Ohio State Univ Experience Letter State of New Jersey Pharmacist Permit

RECEIVED 10/;7/2+3@7 11:37 7037874079 IBA MULECULAF

To Whom It May Concern:

have completed the requirements for nuclear certification. The didactic where 214 hours of classes enclosed with this letter.

was done at Ohio State University, in Columbus OH, mpleted on August 3,2007. The certificate is

+ experience has been completad, 520 hours were Somerset, NJ under the diredion of Jamie Peny and

ourkiani. The other 40 hours were done at under the direction of George Hinkle.

done at the IBA

the Ohio State Univers

to sufficiently hnction

Sincerely,

Hijin Kim, fZPh

Jamie Pmy, RPd ANP Pharmacy Manager

RECEIVED 18/17/2007 1 '2: 42 7037874079 IBA MOLECULAR

APPROVED BY OMS: NO. 31SW1: EWIRES: 10131/2~ AUTHORIZED NUCLEA ClST TRAINING AND

EXPERIENCE AND R ATESTATION

have been obtained within lhe 7 years preceding related continuing education and Bxperiencesince de dales, duration, md description of conhulng

7 1. Boerdcertificatiin

Clock Dates of HOWS Training*

: i I Descripfion of Training , ~. !! Locatin of Training

,!,

8 , ; ; !:

" ! , 1: ~ , I!

Radiation physics and instrumentat& ., . , ~

7/9/07 to 6/3/07

and measurement of radioactiity

7/8/07 to 8/3/67

Radiation biology 7

RECEI'dED 1W17/2907 12: 42 1837874879 IEA MOLECULAR ' , , !

, , , , 8 , ,

' i Description of Experience ~

:!

, ' ! , !

AUTHORIZED NUCLEAR PHARMACIST TRAINING AND EXPERIENCE AND P W X C h O R ATTESTATION (continued)

2. Struct wed Educatlona I Proaram b ProLrosed Autho r b d Nuclear Pharma&$ (continued) b Supervised Pracncal Experience k a Nydear Pharmacy

! ' Location of Experiencekicansa or Clock Bates of i Permll Number of Facility Hours Experience' , ,

dhid!Staie , , I , University 5 7D107 to 6/3/07

1 ;

related radiation surveys , :

Shipping, receiving, and performing , :; ' .

, , , , ,

' i

1 ,

, , 1 ~ ~ ~ l a r / s o m s m t , NJ IBA OieewlarlSterling, VA

, ,. ! , '.

35

7,9107 to 813107

or betaemit@ng radionuclides

Calculating, assaying, and safely prepating dosages for patients or human research subjects

olecuiarlSomerset, NJ obcuiarBterIlng. VA

olecularlSmemet, NJ OiecularBterling. VA Using administrative controls to

medical events in admlnlstratlon byproduct material

Using procedures to prevent or minimize radioactive contamination and using proper decontamination

decularlherset, NJ

e11 8/07 10 io119107

IBA MOLECULAP RECEIVED 10/17/2007 12: 42 7037874079 ' : ; ! !

! , ' i ' ! ~

, # , i i

'20%) : : , I : , ,

. , # '

, , , , , , tC FORM 3 1 s (ANP) ' ! " , , , ~ "' US. N U U U R REGULATORY CWMBSIOI

AUTHORIZED NUt PHARMACiST TRAINING AND EXPERIENCE AND & $ T O R AlTESTAllON (Gontinued)

ote: This part must be completed by

irst Section heck one of the followlng:

Board Certification

has satisfactoflly campleted the requirements in

10 CFR 35.55@)(1), (a)(2), independently as an authori

nd has achieved a level of competency dficient to function

has satisfactorily completed a 70o-hour slnictured

0 hours of classroom and labomtory training, and practical FR 35.55(b)(I) and has achiwed a level of

wmpetency sufficient to fun zecl nudear phamacist. -l________________-.ll_l m d Section mplcte the following for preceptor

iL U _I 3 ti W J 0 E -I E

DI ? 0 e c m c m m r.

ul ro P, 3

c 0 m N .. I. 3 , m 3

..

n W > Y W v W E

- __ Name (L&, First, IniQal) Kim, Hijin Angela, PhamD I Experience OnlYatIBAM~lecularSites-doesnotinoiudeohlo Statehwrs

_.

Isatope(s) Used Maximum amount used at any one time Location of Use Purpose of Use" Total Hours of Exqenence ~

F-18 9 Ci Somerset, NJ 1,4,5,6,7 480 Ga-67 5 mCi 1,5,6 _. cs-I 37 200 uCi vial Somerset, NJ 2.3 Ba-I 33 ZOO uci vial Somerset, NJ 23 . I CO-57 I 5 mci vial Somerset NJ 2.3 [+ 20

I

Tc99m, Mo99 TI-201 1-1 23 1-1 31

I ~

19 ci Sterling VA 1,2,3,4-5,6,7 .2w ~? c 500 mCi Sterling VA 1,4,5,6 _. 7 w -G 200 uCi Sterling VA 1,5,6 1 1-1 31 1,4,5,6 '2

t ~ J

Signature: Title Date: Putuose of Use 10/19/07

1. Shipping, receiwng, ard performing related radiation surveys. 2.

3. 4. 5. 6. 7.

Using and performing checks for proper operation of dose calibrators, survey meters, and other instruments used to measure photon- and high energy beta- emitting radionuclides. Using and performing checks for proper operation of inslrumenls used to measure alpha- and low energy beta- emitting radionuclides Calculating, assaying, and safely preparing dosages for patients or human research sub:ects. Use of administrative wntmls to avoid mistakes in the administration of byproduct material. Use of procedures to prevent or minimize contaminationfor use of proper decontamination procedures. Compounding radiopharmaceuticals for distribution to authorized recipients.

Training record to support ANP on site in Somerset, New Jersey and Sterling, Virginia

NRC RAM #45-25221-01 MD

Isotope(s) Used

F-18 Ga-67 cs-I37 Ba-I33 Co-57

FIGURE G-4 - NUREG 1556, Vol. 13, Appendix G

AUTHORIZED NUCLEAR PHARMACIST EXPERIENCE IN HANDLING RADIOISOTOPE

Maximum amount used Total Hours of Experience at any one time Location of Use Pi-irpose of Use*

9 Ci Somerset, NJ 1,4,5,6,7 480 5 mCi 156.. 1 200 uCi vial Somerset, NJ 293 -.

200 uCi vial Somerset, NJ 2 3 5 mCi vial Somerset, NJ 2,3 .. 20

(Actual use of radioisotopes under the supervision of an authorized user or Radiation Safety Officer, respectively)

Tc99m, Mo99 TI-201 1-123 1-1 31

IBA Molecular North America Corporate Headquarters 100 Executive Drive, Suite 100 Sterling, VA 20166 Phone (703) 787-7900 Fax (703) 787-4078

19 Ci Sterling VA 1,2,3,4,5,6,7 30 500 mCi Sterling VA 1,4,5 6,7 5 200 uCi Sterling VA 1 5 6 1 1-131 1,4,5,6 2

Title: i./c ANP NRC

individual has achieved a level of competency sufficient to independently operate a nuclear pharmacy." '"I certify that the above described traininglexperience has been satisfactorily completed and that the

IBA STE PIC

Signature of Preceptor Authorized Nuclear Pharmacist: Date: 1011 9/07

-. __. _ _ ______. -... .. . L.. Print: Jamie Perry * Purpose of Use I Signature: 1 Title: I Date: I

ANP NRC 1011 9/07 IBA SOM PIC

and high energy beta- emitting radionuclides. Using and performing checks for proper operation of instruments used to measure alpha- and low energy beta- emitting radionuclides Calculating, assaying, and safely preparing dosages for patients or human research subjects. Use of administrative controls to avoid mistakes in the administration of byproduct miiterial. Use of procedures to prevent or minimize contamination/or use of proper decontamination procedures. Compounding radiopharmaceuticals for distribution to authorized recipients.

3. 4. 5. 6. 7.

The Ohio State University College of Pharmacy Medical

and Center University Medical Center Department of Pharmacy

By this certificate warrants that

HIJIN ANGELA KIM has satisfactorily fulfilled all requirements

and completed the prescribed course

Nuclear Pharmacy Certificate Program

Associate Professor of Pharmacy

09. G.A-4 Director, Experiential Programs College of Pharmacy

August 3,2007

- = 3 d-4- Chair, Pharmacy Practice

and Administration

Medical Center THE OHIO STATE LJNIVERSITY

COLLEGE OF PHARMACY

IJniversity, Columhus, OH

UNIVERSITY MEDICAL CENTER

through Pharmacy August 3,2007 Certificate

'Note: Show a breakdown of hours by institution, dates, and subjects. List each hour only once (it.:

I

Authorized Nuclear Phnmiacist/Autliorized User: DATE: August 3 , 2007 George H in le, RPh,MS,BCNP,FASli P,FAPhA

THE OHIO STATE UNIVERSITY COLLEGE OF PHARMACY


NUCLEAR PHARMACY CERTIFICATE PROGRAM

RADIONUCLIDE HANDLING EXPERlENCE

Name: Hijin Angela Kim Date: August 3,2007

Document the actual usehandling of radioactive material under the supervision of an - Authorized Nuclear Pharmacist.

RADIONUCLIDE RADIOACTIVITY

Mo-99 Tc-99rn 1-131 1 - 1 2 Ga-67 TI-20 I In-I I I Sr-89 Sm- I S3 F-18 Cs-137

10 Curies 8 Curies 200 mCi 1 mCi 25 mCi SO mCi 7 . 5 mCi 5 mCi 100 mCi 200 mCi 0.2 mCi

USE sec below

1.2.3.4,5.6,1 I .2.3.4,5.6,7 1.2,3.4,5,6 1.2.3,4.5,6 1.2.3.4.5 1.2.3,4.S 1.2,3.4 1,2,3,4,5,6 l.2,3,4,5.6 I ,?.3,4,5.6 I .2.5

EXPERIENCE LOCATION Actual clock hours

(Include date ranzc of cupcriencc)

7!9/07 The Ohio State University through Medical Cenler 8/3/07 Columbus, OH

TOTALHOUHS: 40 hours

Key for "Use": the number. or numbers. entered tinder YJse" should correspond to the handling experience for each radionuciide.

1 . Ordering, shipping, receiving radioactive materials and performing related radiation surveys. 2 . Calibrating. using and performing checks for proper operation of dose calibrators, scintillation detectors.

survey meters. and, if applicable, instruments used to measure alpha- or beta-emitting radionuclides. 3. Calculating. assaying and safely preparing dosages for patients or human research subjects. 4. Using appropriate internal controls to avoid mistakes in the labeling antl'or administration of by product

material. 5. Using procedures to prevent or minimize contamination and using propcr decontamination procedures. 6. Learning emergency procedures to handle and contain spilled materials safely, including related

decontamination procedures, surveys and wipe tests. 7. Eluting Tc99rn rrom generator systems. assaying the eluate for l'c9Ym and for Mo90 and processing thc

eluate with reagent kits to prepare Tc99m labeled radioactivs drugs.

Authorized Nuclear Pharmaci Date: August 3. 2007

RECEI'dED 1 @ / 1 6 / 2 8 0 7 1 4 : 2 4 71337874079 IBA MOLECULAk PAGE 0 1 / 0 1 1W/16/200: 1 4 : 139 7528738468 E1 SOMEPSET N J

State 01 New Jersey New Jersey OfRce of the Attorney General

Dlvlslon of Consumer Affairs

THIS IS TOCERTIFY THAT,THE Board of Pharmacy

HAS LICENSED

FOR FRAmCE IN NEW J E R S N 43 NN): Plmrm~dst i

PERSONAL INFORMATION WAS REMOVED BY NRC. NO COPY OF THIS INFORMATION WAS RETAINED BY THE NRC.

Thomas M. Lewis, R.Ph. NRC Form 313A(ANP) Empire Isotopes’ Preceptor Letter

ANP Application to NY BOP Ohio State Univ ANP Training Certificate Univ of New York Pharmacist Certificate State of New York Pharmacist Permit

Empire Isotopes Preceptor’s BCNP

IRC FORM 313A (ANP) 1-1

U.S. NUCLEAR REGULATORY COMMISSION

APPROVED BY O M 0 NO 315001. EXPIRES: 1OI131l2008 I AUTHORIZED NUCLEAR PHARMACIST TRAINING AND

EXPERIENCE AND PRECEPTOR ATTESTATION [IO CFR 35.551 I

iam of Proposed Authorized Nudear Pharmacist 6 tae orTerritorVWhere Licensed

PART I -TRAINING AND EXPERIENCE (Select one of the two methods below)

" Training and Experience, including board certifimtiin, must have been obtained within the 7 years preceding the date of application or the individual must have obtained related continuing education and experience since the required training and experience was completed. Provide dates, duration, and description of continuing education and experience related to the nuclear pharmacy uses.

1. Board CerHcation

a. Provide a copy of the board certificaD'on. b. Skip to and complete Pail I1 Preceptor Attestation.

&2. Structured Educatlonal Proaram for Prow sed Authorked Nuclear PharmacM

a. Classroom and Laboratory Training. . . . .. . .

1 I

1 Radiation protection I I

1 i

Mathematics peltaining to the use , j and measurement of radioactivity !

I I ~

IChemistty of byproduct material for medical use

'

Radiation biology

1 I

Radiation protection i - . .

i

Mathematics peltaining to the use , j and measurement of radioactivity !

I 1 . .. I I

medical use

I i Radiation biology

I I I I I

IBG MOLECULGR I l o . 3 6 3 7 2 3

1

!WpiwJ. receiving, and performing 1 related radiation surveys

U.S. NUCLEAR REGULATORY COMMISS IRC FORM 313A (ANP) lm)

.- I 1

E m f i r C I + ~ s U C j F J ~ z / ~ $ - IO b a l k e r W n

A U T H O R E D NUCLEAR PHARMACIST TRAINING AND EXPERIENCE AND PRECEPTOR ATESTATION (continued)

2. &uetu red Educational P r o m for p r o m ed Authorized Nucle ar Pharmacist (continued) b. Supervised Prectical Experience in a Nuclear Pharmacy.

I i 1 Using and performing checks for Proper operation of instruments used

!to determine the activity of dosages, survey meters, and. If appropriate, !instruments used to measure alpha- I or beta-emitting radionuclides

- .

i I

i

I i 1

I -+ !-- I I I

'Using administrative mntmls to avoid ~ 1 medical events in administration of 1 bypmduct material

i i I -. . I +.-- i

\1/ . -- t -.

, I i Using procedures to prevent or

;minimize radioactive contamination , and using proper decontamination procedures

i

l Total HOum of Experience: i

5 4

so I

c. GO to and complete Part It Preceptor Attestation

cA:E 2

3

RC FORM 3iSA (ANP) b m l

U.S. NUCLEAR REQUUTDRY COMMlSSIOh

AUTHORI2ED NUCLWR PHARMACIST TRAINING AND EXPERIENCE AND PRECEPTOR AlTESTATION (continued)

2. Structu- for Pmoosed Authorized Nuclear P e (continued)

b. Supervised Practical Expenence in a Nuclear Pharmacy

I Location of Expenence/License or I Descnption of Experienca , Permit Number of Facilitv

!Using and performing checks for proper operation of instruments used to determine the activity of dosages, survey meters, and, if appropriate, instruments used to measure alpha- or betaemilting radionuclides

Calculating, assaying, and safely preparing dosage8 for pal;eohi or human research subjects

L-.. .

Using wrrninistrstive controls to wold med:cal events in admlnlstmtion of byprodsi mateMl

I I . . . Using procedures . to prevent or I minimze radloaetive contamination and using proper decontamination

Clock Datesof I

Hours , Expenence'

i

- _

Total Hours of Experience: crg 8 .c -... .. . 1

i 1 . . ... . .

c. Go to and complete Part I t Preceptor Attestation

SPGE i

RECEIVED 10/@4/2r?07 10: 47 7037874079 O r \ . 4. i:07 : C : 1 7 V I3A 11C!E':UL>,i

IBA MOLECULhR Y o . 3 6 3 7 j, 5

IRC FORM 313A (ANP) RZm1

U.8. NUCLEAR REGULATORY COMMlSSlOI

AUTHORIZED NUCLEAR PHARMACIST TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)

PART II - PRECEPTOR ATTESTATION

lote: This part must be completed by the Individual's preceptor. The preceptor does no! have to be the supervising individual as long as the preceptor provides directs, or verifies training and experience required. If more than one preceptor is necessary to document experience, obtain a separate preceptorslatement from each.

imt Section :heck one of the following:

Board Certiflcatlon I attest that has satisfactorily completed the requirements in

NW of ROW Aumomed N u d m ~iampclst

10 CFR 35.55(a)(1), (a)(2), and (a)(3) and has achieved a level of mmpetency sufficient to function independently as an authorized nuclear pharmacist.

OR

tured Educational Pro ram &-m. & u3 ; C has satisfactorily completed a 700-hour structured

educational prcgmm consisting of barn 200 h o m of classroom and laboratory haining, and practical experience in nuclear pharmacy, as required by 10 CFR 35.55(b)(I) and has achiwed a level of compe!ency sufficient to function independently as an authorized nudear pharmacist

N a m e t i P m w m t w i w NuclearPtarrmdat'.

..- 11- . - . . . - . - .~1~ .1 . - . I IC I - - -L - -~ - . . . . . . . ~ . . . .~ .~ . . .

:concl Section Dmplete the following for preceptor attestatlon and slgnature: -

. I am an Authorized Nuclear Pharmacist for N O \ eccC,

Nudssr DhenaN cr Whi F&ty

Ime O f Preceptor

$',C\.p.d sb

IBA MOLECULCR Y o , 3637 F 1

-

EMPIRE ISOTOPES, L.L.C. GTI 10 Walker Way

Albany, NV 12206 51046811377 6164529851

November 20, 1998

State Board of Pharmacy Stare Education DepartSWt Cultural Education Center Albany, New York 12230

To whom it may concern,

Thomas M. Lewis, RPh., has completed his 500 hours of clinical nuclear pharmacy training under my supervisim at Empire Isotopes nuclcar pharmacy, Albany, NY Flew see attached copy of my certification as a Nuclear Pharmacist by the Board of Pharmaceutical Specialties.

Please feel free to iontact me at 869-8377 if fbther documentation required

Sincerely,

Pharmacy Manager

RIPN

1. Are you cartifid 4s a Nuclear Pharmacist by the Board o f Pharsacmutica1 Spnisltin o f the hrican PhArnecCUtiCal AsSociPtion?

/ - No

- Y C I Satr b Csr:i?l;etion Nc.

12 y..i rrnd copy o f certification

OR

2. Have you coepleted 200 contact hour@ of didartlc !mtructicn? (attack cvidencl)l

- No

I / - Y c l

3. Hare you completmd a alnimum of SO0 hours o f clinical nuclear phrrnrcy under the supervision of n Board o f PharMcmutiCal 6pPCialtiem Certified Nuclear phrrerciat? (rttrch w i d w e )

- L/' Y N

- NO

rn v w m r. m m c

THE UNIVERSITY OF THE STATE OF NEW YORK EDUCATION DEPARTMENT

BE IT KNOWN THAT

THOMAS M LEWIS

HAVING GIVEN SATISFACTORY EVIDENCE OF THE COMPLETION OF PROFESSIONAL AND OTHER REQUIREMENTS PRESCRIBED BY LAW IS QUA.LIFIED TO PRACTICE AS A

PHARMACIST IN THE STATE OF NEW YORK

IN WITNESS WHEREOF THE EDUCATION DEPARTMENT GRANTS THIS LICENSE UNDER ITS SEAL AT ALBANY, NEW YORK THIS NINETEENTH DAY OF AUGUST, 1987.

LICENSE NUMBER 038052

PRESIOENT OF THE UNlVERSlTY hHD COHMISSIONeR OP EWCATIOH

.I

0 1 I313W

Ronald K. Lough R.Ph. I BA Cover Letter (post dated I 0/25/2007)

N RC Form 3 1 3A(AN P) (post dated I 0/25/2007)

Ohio State Univ ANP Training Certificate Ohio State Univ Didactic Grid Ohio State Univ Experience Letter State of West Virginia Pharmacist Permit

ii .#-., #* ',%< . I , d r , , 100 Executive Drive, Suite 100 I Sterling, VA 20166 1 Toll Free 1877 334 3673 Tel.: +I 703 787 7900 I Fax: + I 703 787 4079 1 ww.iba-wOrldwide.cOm

October 25,2007

U.S. Nuclear Regulatory Commission, Region I Division of Nuclear Materials Safety 475 Allendale Road King of Prussia, PA 19406-1415

RE: License No. 45-25221-01MD

Dear Sir: IBA Molecular North America, Inc. would like to amend the aforementioned license. Please add the following as Authorized Nuclear Pharmacist - Item #11B - credentials enclosed:

All other conditions of the license remain in effect.

Thank you. If you have any questions about this amendment, please contact me or the Corporate Compliance Officer, Jim Kostka a t the Sterling Corporate office (703) 787-7900.

Amendment Reauest to Add Authorized Nuclear Pharmacist

Ronald K. Lough R.Ph.

Franklin J. Kalisz, ANP, RSO IBA Molecular North America, inc. 3601 Morgantown Industrial Park Morgantown, wv 26501 (304) 292-2240

I I 1

http://ww.iba-wOrldwide.cOm

RC FORM 313A (ANP) 1~2006)

U.S. NUCLEAR REGULATORY COMMISSION

APPROVED BY OMB: NO. 3150-012C EXPIRES: ~ o m n o o a AUTHORIZED NUCLEAR PHARMACIST TRAINING AND

EXPERIENCE AND PRECEPTOR ATTESTATION [ l o CFR 35.551

arne of PrODOSed Authorized Nuclear Pharmacist lonaid K. Lough R.Ph.

State or Territory Where Licensed West Virginia

PART I -- TRAINING AND EXPERIENCE (Select one of the two methods below)

* Training and Experience, including board certification, must have been obtained within the 7 years preceding the date of application or the individual must have obtained related continuing education and experience since the required training and experience was completed. Provide dates, duration, and description of continuing education and experience related to the nuclear pharmacy uses.

1. Board Certification

a. Provide a copy of the board certification.

b. Skip to and complete Part I1 Preceptor Attestation.

2. Structured Educational Program for ProDosed Authorized Nuclear Pharmacist

~~~

~-

~~

~ Clock , Datesof Hours l Training'

~ ~4- ~- -~ ,88 i 08/06/07 TO

~ 08/31/07

a. Classroom and Laboratory Training. ,~~~ ~~ ~~ ~~~

Description of Training Location of Training - ~ ~~

OHIO STATE UNIVERSITY !COLLEGE OF PHARMACY

Radiation physics and instrumentation

Radiation protection

OH.0 STATE UhlVERSiTY COLLEGE OF PHARMACY

~ ~- ~~ ~~ ~~~~ ~ ~~~ ~~~~ ~-~ ~- ~~~~

'OUlO STPTE CIN!VERSiTY COLLEGE OF PHARMACY

Mathematics pertaining to the use and measurement of radioactivity

OHIO STATE UhrlVERS TY COL-EGE OF PrlARMACY

Chemistry of byproduct material for medical use

O h 0 STATE JhIL'ERS TY COLLEGE OF PHARMACY

Radiation biology

~

. - ~~~ .- 45 ,, 08/06/07 TO

08/31/07

- ~- ~~~~

~ 20 0B/06!07 TO 08/31 107

08/06/07 TO 08/31/07

39

- _ _ _ 22 06/06/07 TO

06/31 107

Total Hours of Training: 214 HOURS ~~~~ ~~~ ~- -

RC FORM 313A IANP) 110-2006) PR'NTED ON RECYCLED PAPER PkGE

RC FORM 313A (ANP) 1-2006)

US. NUCLEAR REGULATORY COMMISSION


2. Structured Educational Proqram for ProDosed Authorized Nuclear Pharmacist (continued)

b. Supervised Practical Experience in a Nuclear Pharmacy

Location of ExperienceILicense or Permit Number of Facility

Description of Experience ~~ ~~~~~ ~ ~~~~ ~~ ~

IBA MOLECULAR NORTH AMERICA 3601 MORGANTOWN INDUSTRIAL PARK MORGANTOWN, WV 26501

Shipping, receiving, and performing related radiation surveys 'NRC LICENSE # 45-25221-01MD

EXPIRATION 07/31/2013

~~ ~ ~~ ~ ~~ ~~ ~~~

,IBA MOLECULAR NORTH AMERICA Using and performing checks for ,3601 MORGANTOWN INDUSTRIAL PARK proper operation of instruments used IMORGANTOWN, wv 26501 to determine the activity of dosages, !

survey meters, and, if appropriate, ,NRC LICENSE # 45-25221-01MD ~ instruments used to measure alpha- ~EXPIRATION 07/3112013 'or beta-emitting radionuclides

~ ~~~~~~~~ ~~ ~~ ~~ ~~ ~ ~~ ~~ ~~~~ ~ ~ ~

IBA MOLECULAR NORTH AMERICA 3601 MORGANTOWN INDUSTRIAL PARK MORGANTOWN, WV 26501 Calculating, assaying, and safely

IBA MOLECULAR NORTH AMERICA ,3601 MORGANTOWN INDUSTRIAL PARK

I IMORGANTOWN, wv 26501 'Using administrative controls to avoid

~~~ ~~~~~ ~~ ~ . ~~ ~ ~~ ~~~ ~ ~

,IBA MOLECULAR NORTH AMERICA 3601 MORGANTOWN INDUSTRIAL PARK MORGANTOWN, WV 26501

NRC LICENSE df 45-25221-01MD

Using procedures to prevent or minimize radioactive contamination and using proper decontamination procedures EXPIRATION 07/31/2013

Total Hours of Experience: 500 ~~~ ~~ .~ ~

Supervising Individual FRANKLIN J. KALISZ, ANP, RSO

Clock Hours

100

100

250

'25

25

1

Dates of +- Experience* ~~~~

,07/02/07 TO '10/25/07

~- 07/02/07 TO ,10/25/07

,

.. .. ~

07102l07 TO 10/25/07

~~

07/02/07 TO 10125107

c. Go to and complete Part II Preceptor Attestation

NRC FORM 313A (ANP) 110-20061

US. NUCLEAR REGULATORY COMMlSSlOl



Note: This part must be completed by the individual's preceptor. The preceptor does not have to be the SUpeNiSing individual as long as the preceptor provides, directs, or verifies training and experience required. If more than one preceptor is necessary to document experience, obtain a separate preceptor statement from each.

First Section Check one of the following:

Board Certification

I attest that has satisfactorily completed the requirements in ~

N a i k i f Proposed Authorized N i d e a r Plarmac;l

10 CFR 35.55(a)(1), (a)(2), and (a)(3) and has achieved a level of competency sufficient to function independently as an authorized nuclear pharmacist.

OR

Structured Educational Proaram

has satisfactorily completed a 700-hour structured ~~~ ~~

I attest that RONALD K. LOUGH, R P ~ . ~~~~~~ ~~ ~~~~ ~

Name of Propmed Authorized Nuclear Pharmacist

educational program consisting of both 200 hours of classroom and laboratory training, and practical experience in nuclear pharmacy, as required by 10 CFR 35.55(b)(I) and has achieved a level of competency sufficient to function independently as an authorized nuclear pharmacist.

. _ _ _ _ - _ _ _ _ 1 _ _ _ _ _ _ _ _ 1 - - - - - - - - - - - - - - - - . - - - - - - - - - - - - . . - - - - - - - - -

Second Section Complete the following for preceptor attestation and signature:

I am an Authorized Nuclear Pharmacist for IBA MOLECULAR NORTH AMERICA ~~~~~~ ~~~ ~ ~~ ~~

Nuclear Pharmacy o i Medical FaciIiV

WV RP0006216 ~~~~

LicenselPermit NumTi;

~ . ~- ~ ~~~~~ ~~~~~~

',Telephone Number Date

10/25/07 ~~~

Name of Preceptor

FRANKLIN J. KALISZ, ANP, RSO ~~~~ ~~~~ ~~~ ~~~~~~ ~ ~ ~

The Ohio State University College of Pharmacy Medical

and Center University Medical Center Department of Pharmacy

By this certificate warrants that

RONALD K. LOUGH, R.Ph. has satisfactorily filfilled all requirements

and completed the prescribed course

Nuclear Pharmacy Certificate Program August 3 1,2007

eriential Programs College of Pharmacy

c u A Chair, Pharmacy Practice

and Administration


Location of Training

The Ohio State University,

Columbus, OH

Medical Center

Dates of Course 1 Total Attendance Title ~ g;;:

i- 1

August 6,2007 Nuclear 1 214 through Pharmacy

August 3 1,2007 Certificate program


Radiation Protection


TRAINING RECEIVLD IN BASIC RADIOISOTOPE HANDLING TECHNIQUES

Math Pertaining Radiation Radiopharmaceutical to Radioactivity Biology Chemistry

Name: Ronald Lough

4s 20 22 39

BREAKDOWN OF COURSE CONTENT IN CLOCK HOURS

Radiation Physics & Instrumentation

88

88

I I I

Authorized Nuclear Pharmacist/Authorized User: DATE: August 3 1,2007




RADIONUCLIDE HANDLING EXPERIENCE

Name: Ronald Lough

Document the actual usehandling of radioactive material under the supervision of an Authorized Nuclear Pharmacist.

Date: August 3 1,2007

RADIONUCLIDE RADIOACTIVITY

Mo-99 Tc-99m 1-131 1-123 Ga-67 TI-20 1 In-1 1 1 Sr-89 Sm-153 F-18 CS-137

10 Curies 8 Curies 200 mCi 1 mCi 25 mCi 50 mCi 7.5 mCi 5 mCi 100 mCi 200 mCi 0.2 mCi

EXPERIENCE LOCATION Actual clock hours

(Include date range of experience)

8/6/07 The Ohio State University through Medical Center 813 1/07 Columbus, OH

Key for "Use": the number, or numbers, entered under 'Tise" sbouid correspond to the handiing experience for each radionuclide.

1 . Ordering, shipping, receiving radioactive materials and performing related radiation s w e y s . 2. Calibrating, using and performing checks for proper operation of dose calibrators, scintillation detectors,

survey meters, and, if applicable, instruments used to measure alpha- or beta-emitting radionuclides. 3. Calculating, assaying and safely preparing dosages for patients or human research subjects. 4. Using appropriate internal controls to avoid mistakes in the labeling and/or administration of by product

material. 5. Using procedures to prevent or minimize contamination and using proper decontamination procedures. 6. Learning emergency procedures to handle and contain spilled materials safely, including related

decontamination procedures, surveys and wipe tests. 7. Eluting Tc99m from generator systems, assaying the eluate for Tc99m and for Mo99 and processing the

eluate with reagent kits to prepare Tc99m labeled radioactive drugs.

Authorized Nuclear Pharmacist: ,.&we George@. Hhkle,RPh,MS,BCNP

Date: August 3 1,2007

cy @mrb u€ qlptrrnrrcg REGISTERED PHARMACIST LICENSE

July 1, 2007-Jmie 30, 2009

Ronald Lough Registered Pharmacist License # WOO04997

Steven Oliveira, R.Ph. IBA Preceptor Cover Letter Cardinal Health Preceptor Statement Syncor ANP Didactic Grid Syncor Experience Grid Syncor Training Statement Commonwealth of Massachusetts

Pharmacist Permit

IBA MOLECULAR RECEIVED i o / u z / 2 a o 7 09:48 783787407s

Iba Haverhill s7a52 ime3 p .2 Oct 0 2 07 09:53a

1 Documentation of Authorized Nuclear Pharmacist Training

The training outline in the Authorized Nuclear Pharmacist Guidelines has been completed. The Pharmacist is qualified to assume the duties and responsibilities outlined in the guideline. The training included:

Using administrative controls to avoid medical events in the administration of radioactive material Using procedures to prevent or minimize radioactive Contamination and using proper decontamination procedures

1 I Hereby certify that the above training has been satisfactorily completed and that 1 the individual has achieved a level of competency sufficient to independently operate a nuclear pharmacy. 1 I

I Pharmacist Name (Print) sueeA/ O l ; v e ; ~ , Pharmacist Signature Date /da/47

I

RECEIVED 18/82/2087 0 3 : 4 8 7037874073 IBA MOLECULPR Oct 02 07 09:53a I b a Haverhill 9785217083 P. 3

..... ,.. .~ --Y CardinaIHealth

DOCUMENTATION OF AUTHORIZED NUCLEAR PHARMACIST TRAINING

I hereby certify that the pharmacist listed below has been satisfactorily trained and that the individual has achieved a level of competency sufficient to independently operate a nuclear pharmacy.

Pharmacist Name (print) ~ & I J / Z A

Pharmacist Signature Date y,,h$7

Preceptor Name (print) A, f L n y L! Calangol.

I

Y Y

I

I

rrt I

Syncor International Corporation Revised 12/31\97 Radiation Safety Manual

FIGURE 9-4

RADIOISOTOPE HANDLING EXPERIENCE

Name: Steven Oliveira Date:-

Document the actual use/handEng of radioactive material under the supervision of on Authorized Nuclear Pharmacist.

I Mo-99 I 1OCi 1 1.3.457 1 10/7/02-1/10/03 400hrs

2/3/03-2/21103 120hrs

3/24/0341 8/03 160hrs

Total: 680hrs

WHERE EXPERIENCE

GAINED

Stamford. CT

Stamford, CT

Stamford. CT

Key for "Use": the number, or numbers, entered under "Use" should correspond to the handling experience :fir each is*$*pe.

1.

2.

Ordering, shipping, receiving radioactive materlals and pertorming related radiation surveys

Calibrating, using and performing Checks for proper operation of dose wlibmtors, scintillation detectors, survey meters. and, if appropriate, inslrumenls used lu measure alpha- or beta-ernitting radionuclides

Calculating, assaying and safely preparing dosages for patients or human research subjecls

UIing appropriate internal controls la avoid mistakes in the labeling andlor administration of by Product material

5. Using proceuures to prevent or minimize contamination and using proper decontamination procedures

6, Learning emergency procedures to handle and contain spilled materlals safely. including related decontamination procedures. surveys. and wipe tests

Eluting Tc-99m horn generator systems, assaying the eluate for Tc-99m and for Mo-99 contamlnations, and procassing the eluate with reagent kits to prepare Tc-99m labelerl mdi0aCtiVe drugs

3.

4.

7.

Page 9-5

I I

PART I: INTRODUCTION TO AUTHORIZED USER TRAINING PROGRAM (To be completed prlor to attending the first block of AUT program)

Scientific Calculator

Decay Equafion and study the lesson. Answer the

Kit Compounding

Health Physics Instrumentation

d study the lesson. Answer the

MCA

Radiation Physics Introduction

Read Chapters 1, 2,9, 10 in Saha text (pp. 1-30 and 168-217). Answer the questions at end of each chapter.

/

This is to certify that the assignments listed above have been completed. The managerlRS0 have

It is understood that some of the information presented in this self-study program may not be repeated in the formal training program. It is understood that I will be held accountable for this information.

:c<iew& the anpropriate gateriais with ihz new e;;;=lnvaa r . - ,

Note; This form must be returned before ticketslchecks are issued.

Relurn this to. Pharmacist Cevelopmenl, Syncor Inlernallcnal, 6464 Canoga Ave, Woodland Hills. CA 91367 Fax 818-?3?484a

COMMONWEALTH OF MASSACHUSmS

BOARD OF PHARMACY

R 1SSUESTWIS LICENSE TO

I


Ernest0 Samuel, R.Ph. IBA Preceptor Cover Letter Syncor AU Didactic Letter Syncor Didactic Letter and Grid Syncor Experience Grid Butler U n iv Nuclear Pharmacy Didactic

University of New York Pharmacist

State of New York Pharmacist Permit

Diploma

License

lBA N ~ I e ~ t i l a i 100 Executive Drive. Suite 100 1 Slerimg, VA 20166 I Toll Flee. 1 877 334 3673

Tel ' + 1 703 787 7900 1 Fan. + 1 703 781 4079 1 i y~ l v iba-worldwide corn . .

Documentation of Authorized Nuclear Pharmacist Training

The training outline in the Authorized Nuclear Pharmacist Guidelines has been completed. The Pharmacist is qualified to assume the duties and responsibilities outlined in the guideline.

The training included:

Using administrative controls to avoid medical events in the administration of radioactive material

Using procedures to prevent or minimize radioactive contamination and using proper decontamination procedures

I Hereby certify that the above training has been satisfactorily completed and that the individual has achieved a level of competency sufficient to independently operate a nuclear pharmacy.

Pharmacist Name (Print) Ernysto Sap.el / Pharmacist Signature W & U 7 Date 9/21/07

/ ,- ,I " / f

Preceptor Name (Print) _.

Preceptor Signature Date 9/21/07 ,

Syncor International Corporation

The Service Difference .

September 28. 1995

Ernesto Samuel Syncor International Corporation

Dear Emesto:

Congratulations on your completion of the 227 hour didactic Authorized Users Training Course for Nuclear Pharmacists! The enclosed certificate from Butler University. College of Pharmacy, certifies your successful completion of the educational requirements of this course.

As a result of your success, Syncor will submit your qualifications for status as an Authorized User.

Sincerely /- t n . .

\\ Carey Pieper\\ Administrative ecretary

. .

\\ Carey Pieper\\ Administrative ecretary

20001 Prairie S l r e e l * Chatswortn. CA * 91311 18181 886.7400

Syncor international Corporation The Scwrce Llifference

September 28, 1095

Katherine L. Seifert Director, Regulatory 20001 Prairie Street Chatsworth. CA 91 31 1

Dear Ms. Seifert:

Ernesto Samuel has successfully completed the Syncor Authorized Users Training Program, offered from July IO, 1995, to July 28, 1995. and September 11. 1995, to September 28, 1995. Ernesto Samuel sucessfully passed five tests with an average score greater than 70%, and no score less than 65%.

The daily topics covered throughout the cnurse are listed on the attached summary, and the classroom hours (50 minutes per classroom hour) devoted to each topic are:

Radiation Physics & Instrumentation 92 hours Radiation Protection 50 hours Mathematics of Radioactivity’ 24 hours’ Radiation Chemistry 36 hours Radiation Biology 25 hours

:-,- A ^ . ._- ., ,, , ~ >>>,LA ~ .z _ _ ~

.?G.*.hiF, -^ -A i ,~ - \*-. *>. ~ >-2 .-~i

‘Does not include time outside of classroom hours to complete four problem sets handed out prior to class.

The primary instructors have several years of experience in their assigned course topics, as defined in the attached Course Outline. The primary instructors and their titles follow

Ken Breslow, RPh PET Staff Pharmacist I I Paul Gotti. RPh. BCNP Pharmacy Manager David Pellicciarini, B.S. Progrm Manager, Health Physics Michael S. Mosley, RPh, BCNP Sr. Program Manager, Pharmacist Development Tara Dorniter. B.S. Health Physicist. Radioactive Materials Licensing Kristina Wittstrom, RPh, BCNP Program Manager, Education Resources

Ernest0 Samuel has thereby exceeded the minimum 200 hours of didactic training required by the Nuclear Regulatory Commission or Agreement States for anyone applying to be an Authorized User on a Byproduct Materials License.

If I can be of any additional service in providing information regarding the training program for the students, please let me know.

Sincerely,

Michael S. Mosley Si-. Program Manager Pharmacist Development

FIGURE 9-2

FIGURE 2. DOCUMENTING RADIOISOTOPE HANDLING EXPERIENCE

Name Emesto Samuel R p h

EXPERIENCE WITH 2ADlOACTIVE MATERIAL (Actual Use of Radioisotopes Under the Supevision of an Authorized User)

Mo-99 Tc-99m 1-131 Xe-133 1-1 23 1-125 Ga-67 TI-201 In-1 11 Co-57 Cs-137 Ea-1 33

MAXIMUM WHERE EXPERIENCE AMOUNT WAS GAINED USED AT ONE TIME

Syncor International Corp. Stamford, CT

150 mCi 1 Ci 1 mCi

100 uCi 100 rnCi 100 mCi 100 mCi 10 rnCi

250 uCi 250 uCi

DUFLATlON OF EXPERIENCE (actual clock hours)

6/12/95 - 7/7/95 160 Hours

7/31/95 - 9/8/95 240 Hours

1012'9': - 10/20/95 120 Hours

520 Total Hours

TYPE OF

1,2,3.4.5.6 USE

(see key below)

1.6 3.4.5.6 1.3.4.5 1.3.4,5 1,3.4.5 1.3.4,5

1,3,4.5 1.3.4.5 2 2 2

l l l C I ,a,- ,J

Kev for "TvDe of Use"

The number or numbers entered under "Type of Use" correspond to experience in the following activities:

1. Ordering, receiving, and unpacking radioac*&e materials safety, including performance of related . ,

~ . ~ . . . ~ _I I , . . , ~ .. ~ ~ .r5, .e ..I .= i I .-

2.

3.

4

5. Emergency procedures to handle and contain spilled rnateriais safely, including related

Calibration o f dose calibrator, scintillation detectors, and survey meters

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

Appropriate internal control procedures to prevent mislabeling errorS

decontamination procedures. surveys and wipe tests.

Elution of technetium-99rn generator systems, assay and tesjng o f the elute :or molybdenum-99 contamination, and processing the elute with reagent kits to prepare technetium-99m labeled radiopharmaceuticals.

6 .

I I I ! 1 I I I I I I i I

THE UNIVERSITY OF THE STATE OF NEW YORK EDUCATION DEPARTMENT

BE IT KNOWN THAT

ERNEST0 REBELTO SAMUEL HAVING GIVEN SATISFACTORY EVIDENCE OF THE COMPLETION OF PROFESSIONAL

AND OTHER REQUIREMENTS PRESCRIBED BY LAW IS QUALIFIED TO PRACTICE AS A

PHARMACIST

IN THE STATE OF NEW YORK:

IN WITNESS WHEREOF THE EDUCATION DEPARTMENT GRANTS THIS LICENSE

THIS TWENTY-SEVENTH DAY OF AUGUST, 1998. UNDER ITS SEAL AT ALBANY, NEW YORK

LICENSE NUMBER 046481

35m-58

PUeSlOENT OF THE UNlVeRSlTY AND MMMIISIONEU OF EDUCAT?ON

M W X T I Y @ SECRETARY STATE WARD OF

PHARMACY

= Y

Derick Young, R.Ph. NRC Form 313A(ANP) Purdue University Nuclear Pharmacy

Didactic Diploma IBA Experience Grid State of Illinois Pharmacist Permit

:C FORM 313A (ANP) luld,

US. NUCLEAR REGUlATORY COMMISSION

. . . . . . . . . . . . . . . . . . . . . . . . . . . . Purdue University West Lafayem IN 47907 I Radiation physics and instrumentatiim

APPROVED BY OMB: ND. 5150411 EXPIRES: 1013112008 I AUTHORIZED NUCLEAR PHARMACIST TRAlNlNG AND

EXPERIENCE AND PRECEPTOR ATTESTATION [ I O CFR 35.551

Clock

80

I Ime of PraDo5ed Authorized Nuclear Pnarmacist

wick Young Illinois

i State or Territow Where Licensed

PPRT I -.TRAINING AND EXPERIENCE (Sefecr one of the two rnerhods below)

* Tia ring and Expnriance. iiicILcrid baud w'lificalioii. mJs1 have baen obtaineo w h n rnc 7 years Drecedma t l e date cf applicalion or me ina.vidLa nut have 03tB ned related conlinL ng eadcalo? ana exFerence Si'e me rWJ.reo t ranng ard experience Has comple!ed. Provide oaIes dLrstlon ana cascripl.on of cnirinrlng erluca!ion and expe'lence regaled Io lbe n u e a r phar-acy ses

1 1. Board Celtif icalion

e. ?rovide a co?, of tne 9oard Cert'iCation

b Skip to and coqp.e:e Pa? I Preceitoi ACo$lal on

a 2. Structured Educational Prggqrn for Prtmossd Alnhorked Nuclear P h a m e i s l

1 Radiation protectlon I

. . . . . I

'Mathematics pertainir;g !a the iise 1 and measurement of radiaactivlty

Chemistry of byproduct material for ~ medical use

Purdue llnwersity 1 5 6 West Lafayette, IN 47907

1 IPLirdue University IWest Lafayette, IN 47907

~

1 I I

~ 36

I

1 Purdue Univarsiq West LafayeHe, IN 47901

I 27

radiation biology

i I

Total Hours 4f Tralnlng:*23

~ .. Dates of Training"

'December 2005

......... August 2005 -

August 2005. Demmber 2M35

August 2005 - December 2005

i,

. . . . 1 . . . . ~AugU812005 - 'December 2005

,August 2005 - December 2005

RC FORM 3i 3A (ANP) 14W6)

U S. NUCLEAR REGULATORY COMMlSSlOI


2. Structumd Educational Proararn for ProDosed Authorized Nuclear Pharrnaclst (continued)

b Supewised Practical Experience in a INuclear Pharmacy . . . . . . .

Dates of Experience" ...............

Location of ExperiencelLicense or ~ Clock Permit Number of Facility Hours Description OF Experience

Shipping. receiving. and performing related radiation sulveys

GE Healthcare 1053 W Grand Ave Chicaao. IL 60622 " .

IL-01052.01

to determine the activity of dosages, survey meters, and, if appropriate, instruments used to measure alpha- or beta-emitting radionuclides

GE Healthcare Using and performing checks for 1053 w Grand A V ~ proper operation of instruments used Chcago, IL 60622

IL-01052.01

GE Healthcare

Using administrative controls to avoid medical events in adrninistrabon of byproduct material

preparing dosages for patients or human research subjects IL~olo52~o,

GE Healthcare 1053 W Grand ~ v e Chicago. IL 60622

IL.01052.01

1

i I

. . . . GE Healthcare 1053 W Grand Ave Chicago, IL 60622 Using procedures to prevent or

minimize radioactive contamination .and using proper decontamination 'L-01052-01 procedures

! Total Hours of Experience: 734

:210

!4

200

1 I100

I200

PC FORM 313A (ANP) 1.mm1

U.S. NUCLEAR REGUUTORY COMMISSlOh

AUTHORIZED NUCLEAR PHARMACIST TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continuedl

~ ~ ~~ - . -~ - ~


ate: This part must be completed by the individual's preceptor. The preceptor doesnot have to be the supervising individual as long as the preceptor provides, directs, or verifles training and experience required. If more than one preceptor is necessary to doiiument experience. obtain a separate preceptor statement from each.

irst Section heck one of the following:

Board Certification

a I attest that has satisfactorily completed lhe requirements in Name of PWaeSa A,ilMrlUO N U C h I Plarmacisl

10 CFR 35.55(a)(l), (a@), and (a)i$) and has achieved a level of competency sufficient to funchn independently as an authorized nuclear pharmacist.

OR

Structured Educational Prooran?

I attest that m n c k Young has satisfactorily completed a 700-hour structured Nmeof Propme0 A ~ m o & j N i d a ~ r P h w m a d s t

educational program consistinmJ of born 200 hours of classroom and laboratory training, and practical experience in nuclear pharmacy, as required by I O CFR 35.55(b)(1) and has achieved a level of competency sufficient to function in.dependen1ly as an authorized nuclear pharmxist ...........................................................

econd Section omplete the followlng for preceptor attestation and slgnature:

I am an Authorized Nuclear Pharniacist for IBA Molecular, R ~ ~ ~ ~ ~ ~ I I ~ , ti

NRC 45-25221-01

Nu&, Pharmacy or Madid Facility

. L~cenrdPam~l NumMI

. ~~. . . . . . . . . m e of Preceptor ~TeleQhone Numbel

like Baltagiia pi5-372-1a66 . . . . . . . . . .. ~ . .

........... . .

jpo~b;g,20Y ...............

NUREG 1556, Vol. 13, Appendix G

AUTHORIZED NUCLEAR PHARMACIST EXPERIENCE IN HANDLING RADIOISOTOPE

GE Healthcare 1053 W Grand Ave Chicago, TL 60622 Phone (3312) 243 0787

RAM License # K-01052-01

Signature of Preceptor Authorized Nuclear Ph&nacist: Signature:- - Title: tap Y cedfy Lbat the above described trsininglexperience hac. heen satisfactorily completed and h a t Ihe dz&!4dL@ pk41*r-cy individual bas achieved a level ofcompetency sutficienl io independently operate a nuclear pharmacy.” print: k J~~ ,’& (hC/,& h . h Q q L i

Date: lZ/ZO/,<

KtCtlVtU l k l / l b / l k l U / 14: J Y :U j /874079 IEA MOLECULAP i ~ / i 6 / m a 7 1 2 : 43 e153721067 EASTERN ISOTOPES PAGE a i


iba molecular north america, inc., additional request ... · received 10/;7/2+3@7 11:37 7037874079...

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