harma- 0- received ogle 0 · • completion letter: this is an official letter (on purdue...

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THE L:JG C4 _ C -<CICE

18 September 2012

Regional Administrator U.S. Nuclear Regulatory Commission, Region IV Division of Nuclea r Materials Safety Licensing Assistant Section 1600 East Lamar Blvd Ar1ington, TX 760114511

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SUBJECT: Amendment NRC lie: 49-27629-01MD

RECEIVED

St? \ 8 1011

DNMS

PharmaLogic respectfully requests the following amendment to the commercial nuclear pharmacy US NRC Radioactive Materials License # 49-27629·01 MD. The facility is located at 3480 Trigood Drive, Suite 2, Casper, Wyoming 82609.

Add James Cordonier, PharmD as an Authorized Nuclear Pharmacist. This individual has completed the Purdue University Pharmacy Certificate Program and required supervised practical experience. The course completion letter, program certificate. synopsis of course clock hours, NRC Form 313A(ANP) and Pharmaast License documentation are attached.

I "";sh to thank you for your consideration of this request. If there are any further questions. please contact me.

Sincerely,

./j /'1' /' (_-:f'A,.'({ -{ //,1 ~ ~---

Gerard A. Strugala, RPh. BCNP Vice President, OperatIons

PlJ8UC o lq'iIMdlIte Rele ... ~ormal Relea"

NON-PUBUC o A.' Stnsltiv • .seeurity Related o A.7 senslUve Intemal C 0Ih0r. __ -:-_~

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PURDUE UNIVERSITY memo

TO: James H. Cordoni!!f II FROM: KarOl Duncan Weatherman, PharmD. BCNP. FAPhA

August 29, 2012 DATE: SUBJECT: Nuclear Pharmacy Certificate Program Completion

James -

Congratulations on completing the Purdue university Nuclear Pharmacy Certificate Program! Enclosed afC Oil number of documents that will be necessary as you apply for Authorized Nuclear PharmaciM status:

• COMPLETION LETTER: thiS IS an offiCial letter (on Purdue letterhead) sta ting that you have successfully completed the training program and met all of the requirements that have been set forth by both the Nuclear Regulatory Commission and Purdue Unoversity. I generally send two original copies - one for submiSSion and one for your records.

• FINAL CERTIFICATE : iI copy of this can also be includ~ m your re<lueSI for AU stalus and if you 50 desire, can be framed for your personal use,

• SYNOPSIS OF CLOCK HOURS: thiS document summariZes the hourty breakdown of your t raining in the categOties speCified by the U.S. Nuclear Regulatory Commission. Please nOle. page S of the document. entit led "Training Received in Basic Radioisotope Handling Technique s~ , summarizes the tolitl breakdo .... n of course content for both the distance and c.1mpus sessions in chart form. ThiS document contains my signature as Director of Nudear Pharmacy Trainmg Progums.

Keep in mind. Purdue certifies your ZOO hours of didactiC trainmg only - you will need to have an Authorized Nuclear Pharmacist from your facility (or from previous tralnmg expenences if you afe counting hours eilrned during II summer internship or other e~penence) submit an affidaVIt indicating 500 hours o f practICal experience. Please let me know If we can be Of any additional aSSistance in th iS process. It IS usually helpful if you make copies of all of the documents ar'Id keep them in your personal Mes in case you change jobs and need to resubmit your AU stiltus to a different 5Ute. I OI lso keep electronic files of all paperwork ilssociated with the program. Just give us a call If you ever need them.

In conclusion, I would like to WIsh you the best 35 you embark on this new phase of your carur. Nuclear charmacy is a fantastiC area of practice, and hopefully, you will find that you enjoy it as much as I have in my cOIrecr. I would encourage you to continue your educallon in nuclear mediCine and nuclear pharmacy. An ellcencnl method is t o become active in your local nuclear medicine technology organitatlon or to become a member of the Amellcan Pharmacist Associiltion's section on nucle..,. pharmacy. Purdue's Cert ificate Program has given you a foundatIOn that you COIn bUild on, and our facult y remains avai lable to you it you have questions at a later date. Please do not hesitate to contact uS if we can be of ANY help.

Enclosures


NUCLEAR PHARMACY CERTIFICA TE

PROGRAM

Syllapsis a/Clock HOl/rs a/Trail/illg

/(lIIII'S 1I. Ccmlmticr /I Cali!iclIk [lrogmm =77

Ca ll11'lI!' sessiv ,,; Augltst 2012

College u( rh.um.le)'

Dl·p.1rtrncnt of J'hannac), J'racticc

Nuclear rh.Hmacy !'rogr.lms

Purdue Unh'crs ity

West L,,(ayctl(!, Indi.ma 4i907

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HARMA-n 0

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THE l OG Ct;_ CriC ICE

18 September 2012

Regional Administrator U.S. Nuclear Regu latory Commission, Region IV Division of Nuclear Materials Safety licensing Assistant Section 1600 East Lamar Blvd A rl ington, TX 76011-4511

SUBJECT: Amendment NRC Lie: 49-27629-01MD

RECEIVED

SICP 1 S 1U\1

DNMS

PharmaLogic respectfully requests the following amendment to the commercial nuclear pharmacy US NRC Radioactive Materials License # 49-27629-01 MD. The facility is located al 3480 Trigood Drive, Suile 2, Casper. Wyoming 82609.

Add James Cordonier, PharmD as an Authorized Nuclear Pharmacist. This individual has completed the Purdue University Pharmacy Certificate Program and required supervised practical experience. The course completion letter. program certificate. synopsis of course clock hours, NRC Form 313A(ANP) and Pharmacist License documentation are attached_

I wish to thank you for your consideration of this request If there are any further questions, please contact me

Sincerely,

/1 ,/";' /' (-y .. ·,{J ' (/.i' L~

Gerard A. Strugala, RPh, BCNP Vice President, Operations

PUBLIC o IgIrMdi.te Rele ••• at1!armal Releas'

NON-PUBUC o A.) SenslUve-Security Related

PharmaLogic Holdings

o A.7 Sensitive Internal Oothor. __ ~-~

"'I __ ~ O.te: f-rq-I V

1 S. Ocean Boulevard . Suite 206 • Boca Raton . Florida 33432 732-539-9395 . 561-416-0083 FAX

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PURDUE UNIVERSITY memo

-------------------------------------------------------------TO: FROM: DATE:

James H. Cordonier II Kara Duncan Weathennan. PharmO, BCNP, FAPhA August 29, 2012

SUBJECT: Nuclear Pharmacy Certificate Program Completion

James -

Congratulat ions on completing the Purdue Universit y Nuclear Pharmacy Cert ificate Programl

Enclosed arc a number of documents that will be necessary as you apply for Authorized Nuclear PharmaCist sta tus:

•

•

•

COMPlETION LETIER; this is an offiCial letter (on Purdue letterhead) st ating t hat yllu have successfully completed the tra ining program and met all of the requirements that have been set forth by both the Nuclear Regulatory Commission and Purdue UnIVersity. I generally send t wo onginal copies ~ one lor submiSSion and onc for your records.

FINAL CERTIFICATE: a copy of this can also be included 111 your request for AU status and if you so desire, can be framed for your persooal use.

SYNOPSIS OF CLOCK HOURS; th iS document summafl zes the hourly breakdown of your training in t he categor ies specified by the U.S. Nuclear Regulatory Commission. Please note, page 5 of the document. entit led YTraining Received in Basic Radioisotope Handling Techniques", summarizes the t otal breakdo ..... n of course content for both t he dist ance and campus sessions in chart form. This docu menl contains my signature as Director of Nuclear Pharmacy TraiOlng Programs.

Keep in mind, Purdue certifies your 200 hours of didactic training only - you"";l1 need to have an Authorized Nuclear Pharmacist Irom your lacihW (or from previous tralOing expefl~ces jf you are counting hours e,uned during a summer internshi p or other experience) submit an affidavit indicating 500 hours of practical experience. Please let me know if we can be of any additional aSSlst anCt> ill t hiS proce~s. It is usually helpful ,I )Iou make caples of all of the documents and keep them in yOur personal files in case you change Jobs and need 10 resubmit yOur AU status t o a different state. I also keep electronic files of all paperwork associated with the program. Just give us a call If you ever need them.

In conclusion, I would like to Wish you the best as you embark on t his new phase of your career. Nuclear pharmacy is a fantastic area of practice. and hopefully, you will find that you enjoy it as mucn 3S I !lave in my career. I would encourage you to continue your education in nuclear medlCllle and nuclear pharmacy. An excellent method is t o become active in your local nuclear medicine lecnnology organization or to become a member of tne American Pharmacist Association's section on nuclear pharmacy. Purdue's Cert ificate PrQ9ram nas given you a foundation that you can bwld on, and our faculty remains available t o you if you have questions at a later date. prease do not hesitate to contact us if we can be of ANY help .

Enclosures


NUCLEAR PHARMACY CERTIFICATE

PROGRAM

SYllopsis of Clock Holtrs of Traill illg

!fllII"!> II. C",-doll;rr II Cali/ictlte PmSrtl'" ::77

ell/ll/mS s('ssio,,: AI/S"st 2012

Cullege 01 Ph,ul11i1cy

Dl'p.1rtmcnl of I'harmac)" Pr,lcticc

Nuclear Ph.umacy l'rogrJms

Purdue Un iv('rsity

West Llfolycllc, Indi.1na .Ji90i

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NRC FORM 313A (ANP) U.S. NUCLEAR REGULATORY COMMISSION IJ-lOO'j )

AUTHORIZED NUCLEAR PHARMACIST TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION

APPROVED BY OMS: NO. 3150-0120 EXPIRES: 3/31/2012

[10 CFR 35.55J

Name of Proposed Authorized Nuclear Pharmacist i Stale or Territory Where Licensed

' W,·um' u" Ja m" II. C"nJoni"rll I "

PA RT I - TRAINING AND EXPERIENCE (Selec t one of the two methods be/ow)

* 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 Iraining 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 II Preceptor Attestation .

./ 2. Structured Educational Program for Proposed Authorized Nuclear Pharmacist

a. Classroom and Laboratory Training.

Description of Training Location of Training

,Pu rdue Un;""rsil)'

. . . . . ,w est Lafa)'''''''' IN Radiation physIcs and Instrumentation &. I~"ng llisb""" I.u.m' '' l:

I

I ,

Radiation protection

Mathematics pertaining to the use and measurement of radioactivity

[Chemistry of byproduct material for I medical use

I ! Radiation biology

!

l'u"lue IIni"crs;l}" W"st I~rayfllt, I N & I.u,,::, 1)i.~lance I.ea,·n;n~

Purdue I Jni,'ersify ' We:sl l ~fay"tt", IN & Lo,,~ I) ,stanct' Lurnin:.

Purdue IJn,,'cr:sily \ Vest Laf~ycll", I N

1& L.m): Di~lall"c LC>I"";":'

I

I'untll" t l,,;\"cr" 'ty

1.""1; l) i~1>I"cr I.<raming

Total Hours of Training: 21~

46

23

40

"

Clock Hours

, Oates of Training'

.)ul.y 20t2-AugusI2UI2

I

I 'July2U12-Augusl2012

, l.luly 2UI2-I A U~USf 2012

,

1 . l ul~' 2012 -A"gllsl2Ul2

I I ,

.Iul~· 2012-August 2012

,

I

. ,

,

I i ,

,

;

, I I ,

,

I ,

P R'NrrrJON RrCVCU rJ PAPf'R PAGE 1

1b51 1 0

NRC FORM 313A IANP) 13-2009)

U-S_ NUCLEAR REGULATORY COMMISSION

AUTHORIZED NUCLEAR PHARMA CIST TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)

2. Structured Educational Program for Proposed Authorized Nuclear Pharmacist (continued)

b. Supe(\lised Practical Experience in a Nuclear Pharmacy.

Description of Experience

IShipping. receiving, and performing related radiation surveys

, . Using and performing checks for proper operation of instruments used

! to determine the activi ty of dosages,

I sU(\Iey meters. and , if appropriate,

I instruments used to measure alphalor beta-emitting radionuclides

Icalculating . assaying. and safely

I preparing dosages for patients or human research subjects

I Using administrative controls to avoid medical events in administration of byproduct material

Using procedures to prevent or minimize radioactive contaminatton

I and using proper decontamination procedures

Supervising Individual

'Tam iko lish io, I'hannll

! I

Location of ExperiencefUcense or Permit Number of FaCility

r>ha,·mal ."t:;,· \VV

J-tSo T " i);!""d Ih';vc, Ste 2

Casper, WV 82609

I I'harmaLo~il' \\IV

341m Trignnd Dri\'e. Sle 2

lC~sp ... r, WY 8260')

' l'hannaLul!ic ',,"' \ '

34811 T r il:'K,d I) .. i~c. Sic 2 Caspcr, WV 82(,09

I'h, .... maI.Oj:!i ... WV

34110 T,ig'H,d I)r ;H, SI~ 2

C",'rwr, \\IV H26C1!1

l'h",·m" L,,~it· \\IV

3480 T ri!!ood I)'· i ~c. Sle 2

Ic.".spe, .. WV 82609

Total Hours of Experience: 560

c. Go to and complete Part II Preceptor Attestation .

I"" I

120

250

,'"

Clock Hours

I

Dates of Experience'

.Iuoe 11 . 21112

Septfmhfr 7. 2U I2

.Iunf 11,21112 S~I 't~",hn 7,

2012

' .Iunr 11,21112-S~ple",hu 7.

2012

.lun.., I I ,2012

Septemher 7,

2012

1.110 11" I I. 211 12

'Seillemher 7.

2012

HRC FORM 31lA (AHPI (3~1

U.S. HUCLEAR REGULATORY COMMISSION

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

PART 11 - PRECEPTOR ATTESTATION

Note: This part must be completed by the individual's preceptor. The preceptor does not have to be the supervising individual as tong as the preceptor provides, directs, or verifies training and experience required . If more than one preceptor is necessary 10 document experience, obtain a separate preceptor statement from each.

First Section Check one of the following:

Board Certification

I aUest that has satisfactorily completed the requirements in

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

OR

Structured Educational Program

.f I attest that .I~m~ ... 11. (''''',loniH II has satisfactorily completed a lOO-hour structured

Name 01 Pr~ .... ulhonled Nude...- Pl'lalmacSl

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

.------_ .. _----_ ..... ------- .. _----- .... _------_._---------Second Section Complete the following for preceptor attestation and signature:

I am an Authorized Nuclear Pharmacist for l'hllnllMl,oeir \\' V

Nociear Pharmacy 0< MedICal Facility

Name of Preceptor T :uniko Usllio

".

SIg~re

I / /(UI[,./'(/ Telephone Number

I (J01) 261 -7000

"

Date

0911212012

lIome

Highlights

Contact Info

Wyoming State Board of Pharmacy

SlaftlConlacts ".,,' I\f>plir.aliorlS

$eStell Pharmacy Databas"

Stan New $earm

links Seardl Oala base ""

1110 VVyom ln9 Stal .. A0.1I11 01 rh.1 n".1 " ~ W'bt,"~ 111"1 ,t,,,,,,,,ta ,ns Ine 111Iorma l"'''' lo t II , .. I,qms" """fle'""on tuncl lal' ot Ih lS w(>!)S,I" pertOfms d~'l y "r" l tJI~~ ~) ,11 " wehsOiC und cons iders I I'~ w .. b •• ,<> k, be" · ... "u," p" rn ~(~ SO(Jr cc TN Irtcose "",liGal ,,'"

Search Results

License"

35Gl

Firs t Name Mid<l1e Kame

" Last N;o"",

6fle.r.ro12

C"'P,.oghtC 20 10 5WlO ot 'I\yom"'9 All "Uh.s "'~ .,,""'"

DC~"lncd Oy

E.poraUon

12'31'2012

51"'", [hc;pii".

N.,..,e

1 0

•

\~ 9 t!"

\7. 0' - ,

-o

rrt

~ rom: (Sol) 41 e·0085 Je rry St rugill~

PHARMlllOGrC

Ot:;!n 10 PrH·:A I:.-...r-c::....- I, S hi~ Om 13SE?!:

~. ActWgt 1.0 LB

1 South Oce,," S",C. Suite 206 Boca R~~on. FL 33·'32

SHIP TO : (811) aGo·SIDG

Regional Administrator

US NRC Region IV 1600 E LA MAR BLVD

ARLINGTON, TX 76011

~ I C",D 112232511NE'T33CC

[]iJ D,'", • . '''co" EM C,,,

~ ---_.: I III BILL SENDER I Rsf #

Iru .;\. ce ;j

''0' I Dept ~

, ,

~

---------------1 TR", 798962283 117 0201

11 111111111111111111111111

FRI - 14SEP A1

STANDARD OVERNIGHT

76011

AD FWHA r~ ·us

DFW

~ :,\'11 ()9 .,\1\

'~b"_l .1" ', _.

'-

lIy

,-.

,-~

ferle:.: . .:: U !

Hill, Carol

From:

Sent: To: Subject: Attachments:

Dcar Ms. Hill.

[email protected] on behalf of Gerard Strugala [strugala@optonline. net] Tuesday , September 18,20128:26 AM Hill, Carol Re: Request for Amendment of Materials License NRC Amendment Ltr 091812.pdf

I apologi /.c for the incorrect reJcrellcing o flile NRC RAM Li c(!l1sC number in my earlier correspondence.

I ha ve att;l(.:hcd a new cover letter. dated 18 September 201 2. wi th the (':orrcct Rad ioactive Muterials License Number we wish to amend.

If there afC any other questions. pleas(! contact me directl y.

S ince rel y.

Gerard A. Slru!:;ala. RPh. BCN P Pharrnal.ogic I ioid ings Vice Presiden t. Operatio ns 732-539-9395 sl ru g,a I J(i ill Int onl i m: .m:1

On Tuc. Scp IX. 201 2 al 8 :55 I\M. Hill . Carol <('aro l. ll il l((I)nrc.gov> wrote:

Good Morning.

We rece ived the attached request fo r amendment of your Nuclear Materials License to add James Cordonier as <.Ill

authori7J.:d L1s!.!r, however. yo u referenced two diITe ren l li(,:(;!)lse numbers in your letter. License No. 49-27629-0IMD was re l~reneed in the subject linc and License No. 09-29398-01 MD was referenced in the body urlhe letter. Which li cense arc yo u rt=quesling amended?

Caro( L. Hill, Licensing Assistant

DireCl: 817-200-1140

To[[ free: 1-800-952-9677

rax: 817-200-1083

£-ntai[: enroLl li[[(~L~trc.9°V

us Nudear RC9ufatory Commission

1600 E. Lamar Bevd.

Ar[ilUjlOn, TX 76011-4511

2

NRC FORM 532 (1 -2012)

DATE

u. S. NUCLEAR REGULATORY COMMISSION

09118/20 12

NAME AND ADDRESS OF APPLICANT AND/OR LICENSEE

Pharmalogie WY_ Inc. ATrN: Talll iko Ushio. R.rh.

Radiation SalclY Ollicer J4XO Trigood Drive. Suite 2 Casper. Wyoming S26()9

This is to acknowledge the receipt of your:

[,cl LETTER andlor Ii APPLICATION

LICENSE NUMBER

49-276:!I)-O I MD

MAil CONTROL NUMBER

579110

LICENSING ANUIOR TECHNICAL REVII:'NER

ch

DATED: 01)/ 181201 2

The initial processing, which included an admin istrative review, has been performed.

[(] AMENDME NT D TERMINATION D NEW LICENSE n RENEWAL

f71 There were no administrative omiss ions identified during our initial review.

n This is to acknowledge receipt of your application for renewal of the material(s) license identified above. Your application is deemed timely filed , and accord ingly, the license will not expire until final action has been taken by this office.

o Your application for a new NRC license did not include your taxpayer identification number. Please fill out NRC Form 531 , located at the fOllowing link:

http://www.nrc govlreadlng-rmldoc-colieclions/fonnslnrc53 1 pdf

Send the completed NRC Form 531 , by facsimile, to the following number: (301) 415-5387

A copy of your action has been emailed to our license Fee and Accounts ReceivableBranch,in our Headquarters office in Rockville, MD. You will be contacted separately if there is a fee issue involved.

Your application has been assigned the above listed MAIL CONTROL NUMBER. When calling to inquire about this action, please refer to this control number. Your appl ication has been forwarded to a technical reviewer. Please note that the technical review, which is normally completed within 180 days for a renewal application (90 days for all other requests), may identify additional omissions or require additional information. If you have any questions concerning the processing of your application, our contact information is listed below:

NRC FORM 532 (1-20 12)

Region IV U. S. Nuclear Regulatory Commission DNMSINMSB - B 1600 E. Lamar Boulevard Arlington , TX 76011 -4511 (8 17) 200-1103 or (817) 200-11 40

BETWEEN :

Accounts Receivable/Payable

,od Regional Licensing Branches

[ FOR ARPB USE J INFORMATION FROM WBL

Program Code 02500 Status Code: Pending Amendment

Fee Category: 2B 3C

Exp_ Date

Fee Comments:

Decom Fin Assur Reqd : N

License Fee Worksheet - License Fee Transmittal

A. REGtON

1 APPlICATtON ATTACHED Applicant/Licensee: PHARMAt OGtC WY. INC_

Received Date: 09/1 4/20 12

Docket Number 3038007

Mail Controt Number: 5791 10 License Number: 49-27629-01M D

Action Type: Amendment

2. FEE ATTACHED

Amount:

Check No .

3_ COMMENTS

I I

Signed:

Date:

B. LICENSE FEE MANAGEMENT BRANCH (Check ..... hen milestone 03 is entered

1 I ee Category and Amount:

2_ Correct Fee Paid_ Appl ication may be processed for:

Arner ldrnenl:

Renewat

License:

3. OTHER ______________ _

Signed:

Date:

harma- 0- received ogle 0 · • completion letter: this is an official letter (on purdue...

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