ML20127D359

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Responds to FOIA Request for License Application for Mallinckrodt Radiopharmacies in Philadelphia,Pa,Pittsburgh, Pa,St Louis,Mo & Cleveland,Oh.Documents Available in Pdr. Documents 24 & 25 Partially Withheld (Ref FOIA Exemption 6)
ML20127D359
Person / Time
Issue date: 03/29/1985
From: Felton J
NRC OFFICE OF ADMINISTRATION (ADM)
To: Demeis F
SYNCOR INTERNATIONAL CORP.
Shared Package
ML20127D363 List:
References
FOIA-85-130 NUDOCS 8506240206
Download: ML20127D359 (3)
v • d • e


Text

h o g UNITED STATES 8 g NUCLEAR REGULATORY COMMISSION s  ; WASHINGTON, D. C. 20655

\*****/ MAR 2 91985

\

0 Mr. Frank Demets Health Physicist Syncor International Corporation Medical Services Group 10033-M George Palmer Highway IN RESPONSE REFER Lanham, MD 20706 TO F01A-85-130

Dear Mr. Demeis:

This is in response to your letter dated February 22, 1985, in which you requested, pursuant to the Freedom of Information Act (F0IA), copies of the license application for the Mallinckrodt Radiopharmacies in Philadelphia, Pittsburgh, St. Louis and Cleveland.

The documents responsive to your request, as identified on the enclosed appendix, are being placed in the NRC Public Document Room (PDR), 1717 H Street, NW, Washington, DC 20555, for your inspection and copying. We are enclosing a copy of a notice that provides charges and procedures for obtaining copies of records from the PDR.

Portions of documents 24 and 25 have been deleted in order to withhold the address, home telephone numbers, and other personal information related to Mr. Clyde N. Cole, Ms. Kathleen Hagen, Mr. Donald W. Soldan, and Mr. Robert Paul Chandler. Because disclosure of this information would constitute a clearly unwarranted invasion of personal privacy it is being withheld from public disclosure pursuant to Exemption (6) of the FOIA (5 U.S.C. 552(b)(6))

and 10 CFR 9.5(a)(6).

Pursuant to 10 CFR 9.9 of the Commission's regulations, it has been determined that the information withheld is exempt from production or disclosure, and that its production or disclosure is contrary to the public interest. The persons responsible for this denial are the undersigned and Mr. James G. Keppler, Regional Administrator, Region III.

This letter may be appealed to the NRC within 30 days from the receipt of this letter. As provided in 10 CFR 9.11, any such appeal must be in writing, addressed to the Executive Director for Operations, U.S. Nuclear Regulatory Consnission, Washington, DC 20555, and should clearly state on the envelope and in the letter that it is an " Appeal from an Initial F0IA Decision."

l Si rely,

. M. elton, Director Division of Rules and Records Office of Administration

Enclosures:

As stated l 8506240206 B50329 EI -130 PDR i

d Date Originator Recipient Description

1. 04/08/83 Mallinckrodt NRC Application for radioactive materials license (118 pgs)
2. 06/07/83 NRC Mallinckrodt Request for additional infor-mation reference application (8 pgs)
3. 06/30/83 Mallinckrodt NRC Response to 6/7/83 letter (72 pgs)
4. 07/13/83 NRC Mallinckrodt Conversation record (2 pgs)
5. 07/19/83 Mallinckrodt NRC Response to 7/13/83 conversation (13 pgs)
6. 08/01/83 Mallinckrodt NRC Response to 7/28/83 meeting (3 pgs)
7. 08/04/83 Mallinckrodt NRC Documents requested for application (5pgs)
8. 08/05/83 Mallinckrodt NRC Letter transmitting courtesy copy of license supplement (1 pg)
9. 08/05/83 NRC Mallinckrodt Letter enclosing distribution license (2 pgs)
10. 08/08/83 NRC Mallinckrodt Conversation record (1 pg)
11. 08/08/83 Mallinckrodt NRC Response to 8/8/83 conversation (4pgs)
12. 12/05/83 Mallinckrodt NRC Application for radioactive materials license (123 pgs)
13. 12/19/83 Mallinckrodt NRC Request for amendment (38 pgs)
14. 03/06/84 NRC Mallinckrodt Response to 12/19/83 ltr (2 pgs)
15. 03/06/84 NRC Mallinckrodt Request for additional infor-mation ref application (6 pgs)
16. 03/19/84 Mallinckrodt NRC Response to 3/6/84 ltr (18 pgs)
17. 04/10/84 Mallinckrodt NRC Additional response to 3/6/84 ltr (2pgs)
18. 05/08/84 NRC Mallinckrodt NRC application deficiency ltr (1pg) i h

O t .

Date Originator Recipient Description

19. 05/23/84 Mallinckrodt NRC Response to 3/6/84 ltr (11 pgs)
20. 05/24/83 Mallinckrodt NRC Ltr reference amendment request dated 12/19/83 (1 pg)
21. 05/30/84 Mallinckrodt NRC Requestforamendment(7pgs)
22. 06/20/84 NRC Mallinckrodt LtrenclosingAmendment2(1pg)
23. 07/03/84 Mallinckrodt NRC Application for radioactive materials license (73 pgs)
24. 08/01/84 Mallinckrodt NRC Application for radioactive materials license (78 pgs)
25. 09/05/84 Mallinckrodt NRC Forwards information regarding review of license application (35 pgs) 26, 10/08/84 Mallinckrodt NRC Response to NRC request for information regarding license application (20 pgs) 27, 11/09/84 Mallinckrodt NRC Request for amendment (8 pgs)
28. 12/10/84 NRC Mallinckrodt Telephone conversation record (1 pg)
29. 01/10/84 Mallinckrodt NRC Notification of change to infonnation listed in 11/9/84 ltr (1 pg)
30. 01/15/85 Mallinckrodt NRC Request for amendment (8 pgs)

Mallinckrodt, ince '

828 MAHLER ROAD -

BURLINGAME, CALIFORNIA 94010 -

(415)692-4101 April 8, 1983 U.S. Nuclear Regulatory Commission Office of Nuclear Materials Safety and Safeguards Washington D.C. 20555 Dear Gentlemen; Mallinckrodt, Inc., hereby makes application for a radioactive materials license. The license is for a nuclear pharmacy which will possess, store, dispense and distribute radiopharmaceuticals.

As a nuclear pharmacy, Mallinckrodt would provide hospitals and clinics in the area with a total nuclear medicine service. This service will include shipment of radiopharmaceuticals, limited pick-up of radioactive waste, radiation safety programs (e.g. dose calibrator calibrations, wipe tests, etc.), and technical assis-tance.

Mallinckrodt is currently involved in licensing the distribution facility located at Independence Court, Bay #20, Folcroft, PA, as a pharmacy. A copy of the pharmacy permit will be submitted to the Nuclear Regulatory Commission upon its receipt.

We believe this application to be complete in its entirety.

Should me at (you 415) require 692-4101 anyor additional information, please contact (314) 895-2000.

Sincerely yours,

/4 f

Clyde N. Cole Manager Nuclear Pharmacy Operations OfD unu sua a '

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.S. NUCLEAR REGULATORY COMMISSION Director Office of Nuclear Materials Safety and Safeguards MALLINCKRODT, INC. APPLICATION FOR RADIOACTIVE MATERIALS LICENSE 4

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NRC FORM 313A

..a. NUCLE AR CEEULATORY COMMIS$10N Aoprooed tmr OM8 10 CFR 36 APPLICATION FOR MATERIALS LICENSE - MEDICAL [ '.,3 33 INSTRUCTIONS - comoarte ome t aroue n or e.e a e artes ent<stoon or e annat on fw un rene.mt awomentet ofeerrs a oncenne enere neceanery Inun N muet be corrweered on att apostatens and sopro Reto.n orw cooy Submot orngonat one one coor of ent re oorwaren to . Duncser. Offoce of Nucneer Anervnen Sekty md Sereguera. U.S kucteer Repssetory Commanoon. 0%nhangton. O C.

20555 voon ooroner of shne anoineren me annazer anut recereo e heetenals Locener An NRC heeternees Lscenar a noved on a ence metn the poneret roounwnenn cenamune m Tornr 10. Code of foamrer Reputatsons Port 30 md the Lwenner a svaract to Tore to Coor o! Federat Repukteru. Parn 19. M and 35 and er lanne fer provosen o! Totte to. Coor o! Fooerat Repuistrons Part I?O The acese few carspory mover ao sosted a taen 2 war me asuresnew Aue anedessd 1.4. NAME AND MAIUNG ADDRESS OF APPLfCANT (msDarpon, fem e 1.tk STREET ADDRESS (ES) AT WHICH R ADIOACTIVE MATERI AL ncbOdt, LUDE ZIP CODE W from MalIaIc.oh sacaen etc)nc. i Ma nc rOdt,D /t/etArteInc . f.41 INCLUDE ZIP CODE

_EU Diagnostic Imaging Services Diagnostic Imaging Services 675 McDonnell Boulevard Hazelwood, MO 63134 Independence Court Bay #20

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F 1 r ft, PA 19032 TETE,woNE No.. AREA CooE1314,19.5-2000 g'f pyg

2. PERSON TO CONTACT REGARDING THIS APPUCATION 3. THIS IS AN APPUCATION FOR: / Check aparapnese reml Clyde N. Cole 49 NEW UCENSE Manager Nuclear Pharmacy Operations TE LEPwoNE NC. ARE A CoOE I a a AMENouENT To uCENSE No.

MMC

4. INDIVIDUAL USERS (Name sneescluals who w,// use or elecery S. RADIATION SAFETY OFFICER (RSO) (Nemo of oerson desspeed a,oorvan un or red.oecture menner. Cornosea suooiements A and e eoreach mse duer.

a res,,t,on ,1ety on.cor. !oea ma, me.,duer u.a. wmose,, re.r.

Clyde N. Cole (see attached ""*'""'"**"*"*****"'"

Clyde N."" Cole Item 4)

N Donald W. Soldan, Corporate

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am w evoj W 1.M.,

gpp. 3c23 Radiation Safety Officer 6.a RADIOACTIVE MATERIAL FOR MEDICAL USE MAXIMUM MARK MAXIMUM ITEMS POSSESSION ITEMS RADIOACTIVE MATERIAL DESIRED LIMITS ADDITIONAL ITEMS: POSSESSION DESIRE D UMITS USTED lN: "x" (In mothcunes) x** (In trutheurses) 10 CFR 31.11 FOR IN VITRO STUDIES IODINE.131 AS lODIDE FOR TREATMENT i

OF HYPERTHYROIDISM 10 CFR 35.100. SCHEDULE A. GROUP I AS NEE DE D PHOSPHORUS-32 AS SOLUBLE PHOSPHATE FOR TREATMENT OF POLYCYTHEMI A 10 CFR 35.100, SCHEDULE A, GROUP 11 AS NEE DED PHOCPHORUS.32 AS COLLOID AL CHROMIC PHOSPHATE FOR INTRACAVITARY TRE AT.

10 CFR 35.100. SCHE DULE A. GROUP 118 MENT OF MALIG.'J ANT E FFUSIONS.

GOLD. IIB AS COLLOID FOR INTRA.

10 CFR 35.100. SCHEDULE A. GROUP IV CAVITARY TRE ATMENT OF MALIGNANT AS NEEDE D E F FUSIONS.

l IODINE.131 AS LODIDE FOR TREATMENT 10 CFR 35.100. SCHEDULE A. GROUP V AS NEEDED OF THYROID CARCINOM A XENON 133 AS GASOR GASIN SALINE FOR 10 CFR 5.100. SCHEDULE A. GROUP VI BLOOD FLOW STUDIES AND PULMONARY FUNCTION STUDIES 6.b. RADIOACTIVE MATERIAL FOR USES NOT LISTED IN ITEM 6.a. (Sansedsouressuo m JmCiusedfor cohbretoon and reference stonderds are authorised uncier Secoon 36.14fd).10 CFM Mort 35, and NEED NOT BE LISTEDJ CHEMICAL MAXIMUM NUMBER j

l ELEMENT AND MASS NUMSER ,]Nj/OR PO M OF MI OF C ES DESCRISE PURPOSE OF USE see attached Item 6 1 RECDVE MfU 4 @ r*. *****'

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  • INFORMATION REQUIRED FCR ITEMS 7 THROUGH 23 For items 7 through 23, check the appropriat) box (es) and submit a detailed description cf all the requested information. Begin each item on c separate sheet. Identify tha item number and th)dat)cf the application in the lower right corner of each page, if you indicate and datethat anreferenced appendix to th2 medical licensing guide

, Rev. will b3 followed, do not submit the pages, but s number of the guide: Regulatory Guide 10.8 1 Date0ctober 19 O i

7. MEDICAL ISOTOPES COMMITTEE 15. GENERAL RULES FOR THE SAFE USE OF RADIOACTIVE MATERIAL / Check Onel rl/a Names and Specialties Attached;and Appendix G Rules Followed;or Duties as in Appendix 0;or X Equivalent Rules Attached (Check One)

Equivalent Dutias Attached

16. EMERGENCY PROCEDURES (Check Onel
8. TRAINING AND EXPERIENCE Appendix H Procedures Followed;or Supplements A & B Attached for Each Individual User; and see item 8 E@ivalm PWa Ahd Supplement A Attached for RSO. 17. AREA SURVEY PROCEDURES (Check One)
9. INSTRUMENTATION (Check One) Appendix i Procedures Followed;or Appendix C Form Attached;or X Equivalent Procedures Attached X List by Name and Model Number 18. WASTE DISPOSAL (Check Onel
10. CALIBRATION OF INSTRUMENTS Appendix J Form Attached;or Appendix D Procedures Followed for Surysy instruments; or X EquivalentInformation Attached (Check One)

X Equivalent Procedures Attached;and 19 WEWEWC(Check USEOne) & MNHANCMCRS Appendix D Procedures Followed for Dose X Calibrator; or Appendix K Procedures Followed;or Equivalent Procedures Attached X Equivalent Procedures Attached

11. FACILITIES AND EQUIPMENT 20. THERAPEUTIC USE OF SEALED SOURCES X Description and Diagram Attached :1/a Detailed Information Attached;and
12. PERSONNEL TRAINING PROGRAM Appendix L etocedures Followed;or X Description of Training Attached Equivalent Procedures Attached PROCEDURES FOR ORDERING AND RECEIVING PROCEDURES AND PRECAUTIONS FOR USE OF RADIOACTIVE MATERIAL 21. RADIOACTIVE GASES (e.g. Xenon - 133)

X Detailed Information Attached X Detailed Information Attached PROCEDURES AND PRECAUTIONS FOR USE OF PROCEDURES FOR SAFELY OPENING PACKAGES

14. CONTAINING RADIOACTIVE MATERIALS 22. RADIOACTIVE MATERIAL IN ANIMALS (Check Onel 1/a Detailed Information Attached X Appendix F Procedures Followed;or ^'

23 RADIOACTIVE MATERIAL SPECIFIED IN ITEM 6.b g

Equivalent Procedures Attached X

NIC FORM 313M 19-41) j

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M. PERSONNEL MONITEING DEVICES TYPE gg ,,,,,,, m p SUPP LIE R EXCHANGE FREQUENCY FILM a.WHOLE BODY T'O OTHE R (Speco4)

FILM

b. FINGER yto OTHE R ISpecs/y/

FILM

c. WRIST TLD OTHER (Specify)
6. OTHER (SpecWy)

Please refer to Section 4 of the Radiation Safety Program for applicable information.

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lE. FOR PRIVATE PRACTICE APPLICANTS ONLY

s. HOSPITAL AGREEING TO ACCEPT P ATIENTS CONTAINING R ADIOACTIVE M ATE RI AL N AME OF HOSPITAL tt ATTACH A COPY OF THE AGREEMENT LETTER SIGNED BY THE HOSPITAL ADMINISTRATOR.

M AILING A REss

c. WHEN REOUESTING THER APY PROCEDURES.

' ATTACH A COPY OF R ADI ATION SAFETY PRECAU-ClT V STATE ZIP CODE TIONS TO BE TAKEN AND LIST AVAILABLE R ADI ATION DETECTION INSTRUMENTS.

lE. CERTIFICATE (This item mus t be completed by noptican t)

The ar ,ucant and any official executing this certificate on behalf of the applicant named in item la wrtify that this application is prepared en l conformity with Title 10. Code of Federal Regulations, Parts 30 and 35.and that all enformation contained herein. inewing any supplements attached hereto. es true and correct to the best of our knowledge and belief.

tt APPLt NT OR CER YING OFFICIAL (Spaattel

s. LICENSE FEE REQUIREC //6 A yl --

ISee Secacus 170.31.10 CFR 170) f'iNANEIT Clyde T. of Prolt)Co e

< 11) LICENSE FEE CATEGORY: W TITLE Byproduet materials anager y lear Pharmacy s

c. DATE Vl'"'"**V"*
12) LICENSE FEE ENCLOSED: $ 190.00 April 8,1983 I

NRC FORM 313M 19 811 Page 3

- - _ . -- . _ . . - _ _ . . . - . . . _ . _ _ - - _. , . _ _ = _. ._. . - . . . . _ - - - - _ _ -

ITEM 4: INDIVIDUAL USERS In addition to those individuals listed on NRC Form 313M, please list the following:

Donald W. Soldan Kathleen A. Hagen Richard A. Sheriif[y - c *c  ; -l_~ 1 (, ,,u . . , f

, , , ,i Carl E. Wood i n t n.-;:_

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ITEM 6: RADIOACTIVE MATERIALS DATA Element Chemical / Physical form Activity

  • Description of use A. Molybdenum- by Molybdenum-99/ Technetium- 35 Ci Production of Technetium-99 99m generator, manufactured, 99m Pertechnetate for labeled, packaged, and dis- distribution to licensed tributed in accordance with recipients and/or use wit at specific license issued reagent kits for preparac

?ursuant to Section 32 73 of tion and distribution of LO CFR Part 32 or a specific radiopharmaceuticals conc License issued to a manufac- taining technetium-99m ts burer by an Agreement State licensed authorized rec-

?ursuant to equivalent State ipients as stated in regulations. Group III, Schedule A, Section 35 100 of 10 cFR Part 35 B. Technetium- Any form listed in Groups 25 Ci Storage, dispensing, and/

99m I and II of Schedule A, or distribution of pre-Section 35.100 of 10 CFR 35 pared radiopharmaceutica3 to authorized recipients.

Use of technetium-99m peg technetate for processing with reagent kits in the

_ preparation of radio-e,,7.c p pharmaceuticals.

L Xenon-133  % Unit dose containers 4f gas bIr gas 1H solutl~on that is

[ Receipt, storage, and distribution to author-the subject of an active NDA ized recipients in indiv-or IND that has been acceptec idually prepackaged quan-by the FDA.** tities. Individual packe ages are not to be sub-divided or opened.

D. Iodine-131 Any form listed in Groups 500 mci Receipt, storage, dispen-I through V of Schedule A, sing, and/or distributiom Section 35100 of 10 CFR 35 of prepared radiopharma-ceuticals to authorized recipients.

D. Cobalt-57 Sealed source 10 mci Instrument calibration E. Cesium-137 Sealed source 250 uCi Insturment calibration F. Barium-133 Sealed source 250 uCi Instrument calibration G. Iodine-129 Sealed source 250 uCi Instrument calibration H. Xenon-127 Gas as supplied by the man- 500 mci see Item C ufacturer, which is the e subject of an active NDA or IND that has been accepted by the FDA.

Item 6/4-8-83

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ITEN 6: RADIOACTIVE MATERIALS DATA

( Element Chemical / physical form Activity Description of use I. Any byproduct Any form listed in Group I 50 mci See Item o material,ex- of Schedule A Section -

cept Iodine- 35 100 of 10 CPR 35 131, listed in Group I of Schedule A.

Section 35 10 )

of 10 CFR 35 J. Any byproduct Any form listed in Group II 400 mci See Item D material, ex- of Schedule A. Section cept Iodine- 35 100 of 10 CFR 35 131, listed in Group II-of Schedule A Section 35 100 of 10 CFR 35 i K. Any byproduct Any form listed in Group IV 100 mci See Item D material, ex- of Schedule A, Section

( [y) I[N-t 35 100 of 10 CPR 35 in Group IV

, 4 of Schedule A l \' Section 35 100 l of 10 CFR 35 i

L. Any byproduct Any form listed in Group V 50 mci See Item D material, ex- of Schedule A. Section cept Iodine- 35100 of 10 CPR 35

! 131, listed

. in Group V of Schedule A, Section 35 100 of 10 CFR 35 /

    • FDA: Food and Drug Administr stion IND: Investigational New Dru;g NDA: New Drug Application O

i Item 6/4-8-83

(

ITEX 8: TRAINING AND EXPERIENCE A. Clyde N. Cole Manager Nuclear Pharmacy ODerations Mr. Cole received a Masters Degree in Nuclear Pharmacy from the University of Southern California, Los Angeles. He served as a Nuclear Pharmacist for five years withthe U.S. Army (stationed at Letterman Army Medical Center, Presidio of San Francisco, CA) and was on the U.S. Army Radiologic Emergency Medical Team for three years. Before accepting his present position with Mallinckrodt, Mr. Cole held the position of Chief Nuclear Pharmacist for RadPharm, Inc. for a period of six years. He has been Chairman of the Radiation Safety Com-mittee of RadPharm for li years. He has served as Adjunct Professor in the University of California, San Francisco and University Pacific Pharmacy School, teaching the responsibilities of Nuclear Pharmacy. Mr. Cole is currently listed on California State Radioactive Materials Licenses:

3219-70, 2657-90, and 3778-41.

B. Frank M. Gwynn p)o Registered Pharmacist see attached supplement A C. Barbara D. Scavullo tdt Registered Pharmacist see attached supplement A D. Donald W. Soldan CorDorate Radiation Safety Officer The Corporate Radiation Safety Officer for Mallinckrodt for a period of 15 years has a total of 24 years experience in the field of radiation safety. He has had experience in the hand-ling or control of megacuries of radioactive materials under Type A specific licenses of broad scope. He is Chairman of the Radiation Saftey Committees for Mallinckrodt, Inc. , under NRC licenses 24-04206-01 and 24-17450-01.

Mr. Soldan is a member of the American National Standards Institute Committee N14 7 on the packaging of radioactive materials.

E. Kathleen A. Hagen Manager Regulatory Comoliance. Diagnostic Immaine Services Ms. Hagen is a Registered Nuclear Medicine Technologist. She received her training throgh the U.S. Navy School of Nuclear Medicine, Bethesda, MD. Prior to accepting her present position with Mallinckrodt, Ms. Hagen served as Facility Manager for RadPharm, Inc. , Los Angeles, for two years. This facility is a Commercial Nuclear Pharmacy, with branch offices in Los Angeles and San Francisco. Corporate headquarters for RadPharm are located in Burlingame, CA. Ms. Hagen is currently listed on California State Radioactive Materials Licenses 3219-70.

Item 8 /4-8-83

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1 ITM 8 : TRAINING AND EXPERIENCE .

P. Richard A. Sheriff Nuclear Pharmacist see attached statement of training G. Carl E. Wood Nuclear Pharmacist i e

see attached statement of training, r'

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State of California Radiologic Health Section Depar tmen t of Heal th a ram o California 8'i"1 STATEMENT OF TRAlHING AND EXPERIENCE (this form submi tted in lieu of Form # R2050-H which has not been recieved!

1. C ar l 'E. Wood Jr . R .Ph. Regi stered Pharmacist 7910 East Lakeview Trail, Orange, California 92669
2. Prepara t icn of Radiopharmaceu tical s
3. TR AINING : a.High School Graduate b .Universi ty of Washing ton, Sea t tle, Washington 5 years completed. degree in Clinical Pharmacy-BS Pharmacy
c. Education specifically applicable to use of radioactive ma terial completed a t Mercer Universi ty School of Pharmacy Atlanta, Georgia 30312 ..
1) Radiation Physics and Ins trumenta tion 3.0 Credit $f r s
2) Radiopharmaceuticals 3 0 Credi t Mrs.
3) Radiation Biology 3 0 Credit Hours
4) Nuclear Pharmacy Laboratories 9 0 Credit Hrs.

The above educational experience represents 180 contact hours L. EXPERIENCE:

a.) DATES: Frem; January 1982 To;present( April 9, 1992) iltle and Duties: Nuclear Pharmacist in Training Employer: Nuclear Pharmacy incorp. 2511 W. LaPalma , Anahe im CalI f. 92801 b.) Radioactive Materials Previously Used:

QUANTITIES HANDLED Microcuries Millicuries Curles Kilocuries Scaled sources Cs-137 200uCl Co-57 10 MCI Uns g g pha ilnsealg* beta gama Cb-57, 1-131, P-32 Xe-133 Teo %

Co-58 Sc-7 5, yb l 69,C r 51 T1-201, noa9

'leutron sources in111,I-125, I-123 . Ga-47

p gel 2 s

c.) 4A1 As a Nuclea r P ha rmaci s t , in training I have been per forming, under supervision, all the duties of a Nuclear Pharmacist who practices in a Centralized Nuclear Pharmacy, including, but not limited to: reconstitution of radiopharmacuetical kits, dispensing of unit dose and multiple dose radiopharmaceuticals , ca libration of <

1aboratory Instruments, quality control of compounded radiopharmaceuticals, shipping, packing,00T labeling of radioactive ma terials.

d.) Types of facilities I have used:

Ordinary Chemical Laboratories

" Controlled Area"(type B) labora tories Field operations wi th por tab le equipment

5. CERTIFICATE:

I hereby certify that all Information contained in this Statement is true .

and correct. /'

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$ 9 b) _

'sig na tu re o f proposed ug date w

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i Nuclear Pharmacy 1/82-present Function (Approximate hours training in addition to formal coursework)

Ordering and Receiving- determination of products needed:

(34 hours3.935185e-4 days <br />0.00944 hours <br />5.621693e-5 weeks <br />1.2937e-5 months <br />) ass ignment of batch numbers coununication with vendors survey of products received (radiation detection via survey ins trumenta tion and wipe testing)

Storage of Ma terial s- placement of materials in appropriately (14 hours1.62037e-4 days <br />0.00389 hours <br />2.314815e-5 weeks <br />5.327e-6 months <br />) shielded storage areas and varification of radiation safety in these areas Prepara tion of Products- Assignment of in-house lot numbers (105 hours0.00122 days <br />0.0292 hours <br />1.736111e-4 weeks <br />3.99525e-5 months <br />) determination of product needs and caculation of product cons ti tuents Milking Generators Calibration of Elution Solutions Preperation of Kits used as products Calibration of prepared kits (use of dose calibrator) constant review of radiation safety during preparation of kits verification of proper product and production technique disposal of waste materials f rom production via weste protocol review of production records Quali ty Contrcl- verification of proper production and (68 hours7.87037e-4 days <br />0.0189 hours <br />1.124339e-4 weeks <br />2.5874e-5 months <br />) dispensing techniques survey of generator elutions (Mo. Break-through, Alumina Break-through , eluant puri ty via chromatog raphy, mul tichannel a na lysis) survey of kit proparations (proper calibration, kit purity via chromatography, proper particle size for particulate prep-arations) microbiological analysis (culture of elutions and ki ts , pyrogenici ty testing) review of quality control records 14525

( b-Dispensing- receiving perscriptions/ transforming telephone (280 hours0.00324 days <br />0.0778 hours <br />4.62963e-4 weeks <br />1.0654e-4 months <br />) orders into valid, complete perscriptions verification of proper products as per perscription preparation of unit dose, multidose and prepacked products for dispensing- use of safety proceedures In dispe'nsing uni t dose and multidose radiopharmaceuticals verification of proper labeling of all products disposal of radioactive and biological waste materials as per waste protocols Packaging / Shipping- verification of proper product in proper and (34 hours3.935185e-4 days <br />0.00944 hours <br />5.621693e-5 weeks <br />1.2937e-5 months <br />) appropriate container (ie: unit dose pigs, mul tidose lead vial scleids, etc.)

preperation of proper shipping containers per DOT i

requirements (DOT labels, determination of T.I . , proper and conpleted shioping labels and precautions) shipping case sealed with security seal and case wipe tested for removable contamination completed bill of lading for shipment securment of shipping container in transportation vehicle verification of transport of proper package to proper customer review of transportation records Receipt of Waste Materials and Storage- inspection of container prior to removal f rom (34 hours3.935185e-4 days <br />0.00944 hours <br />5.621693e-5 weeks <br />1.2937e-5 months <br />) customer facility completion of proper transportation record (waste received records) shipping container pr-operly secured in transport vehicle inspection and survey of containers upon return to facility seperation of waste product by half-life and storage in appropriate waste caves survey of containers / final clean-up of containers and preperation for their reuse (ammo boxs use for NPI shipments) proper handling and disposal of all biological waste l

review of waste protocols and records l

Regulatory- enforcement, review, and Information concerning (55 hours6.365741e-4 days <br />0.0153 hours <br />9.093915e-5 weeks <br />2.09275e-5 months <br />) all licenses from California Radiation Health, California State Board of Pharmacy, Department of Transportation, and local agencies i

l

l C' i Radia tion Saf ety- formal and Informal, on-going survey of (70 hours8.101852e-4 days <br />0.0194 hours <br />1.157407e-4 weeks <br />2.6635e-5 months <br />) restricted and nonrestricted areas of f acility and personnel Instruction and enforcement of proper technique in all aspects of radiochemical handling, shipping, and, storage regularly scheduled Bloassay for personnel isotope uptake enforcement and Information on ALARA program and CALRAD saf ty proceedures information and assistance to customers concerning radiation safety i

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-- k FORMAL CLASSR0OM AND LABORATORY TRAINING IN RADI0lSOTOPE HANDLING

1. Radiation Physics and ins trumentation 20 hours2.314815e-4 days <br />0.00556 hours <br />3.306878e-5 weeks <br />7.61e-6 months <br /> lecture 68 hours7.87037e-4 days <br />0.0189 hours <br />1.124339e-4 weeks <br />2.5874e-5 months <br /> supervised laboratory
2. Radiation Protection 15 hours1.736111e-4 days <br />0.00417 hours <br />2.480159e-5 weeks <br />5.7075e-6 months <br /> lecture 32 hours3.703704e-4 days <br />0.00889 hours <br />5.291005e-5 weeks <br />1.2176e-5 months <br /> supervised laboratory 3 Mathama tics pertaining to use and measurment of radioactivity 15 hours1.736111e-4 days <br />0.00417 hours <br />2.480159e-5 weeks <br />5.7075e-6 months <br /> lecture 32 hours3.703704e-4 days <br />0.00889 hours <br />5.291005e-5 weeks <br />1.2176e-5 months <br /> supervised laboratory
4. Radiation Biology 30 hours3.472222e-4 days <br />0.00833 hours <br />4.960317e-5 weeks <br />1.1415e-5 months <br /> lecture 5 Radiopharmaceutical Chemistry 30 hours3.472222e-4 days <br />0.00833 hours <br />4.960317e-5 weeks <br />1.1415e-5 months <br /> lecture All lectures and laboratories at Mercer University School of Pharmacy. NPI at San Diego, and NPI at Anaheim.

10 hours1.157407e-4 days <br />0.00278 hours <br />1.653439e-5 weeks <br />3.805e-6 months <br /> training and review of facility IIcense

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CEP.TIFICATE OF TRAllfillG TYPE OF TRAll!!!!G ' DURATl0ll tillERE TRAL!!EO FORitAL OF TP.AllilflG O!! Tite JOB COUP.5E PRiflCIPLES Afl0 PRACTICES ,

OF RADI ATIOtt PROTECT 10tl PURDUE UtilVERSITY 2 YEARS YES YES RADIDACTIVITY HEASUREMErlT, STAllDARDlZATl0tl, AND H0lllTORiflG TECHillQUES, AFID lilSTRUMENTATI0ff PURDUE UtilVERSI TY 2 YEARS YES YES i

MATHEMATIC AtID CALCULATl0flS BASIC TO THE '

, USE OF A!!D flEASUREi:Effi 0F RADl0 ACTIVITY PUROUE UtilVERSITY 2 YEARS YES YES BIOLOGICAL EFFECTS OF RADIATIOli PURDUE UtilVERSITY 2 YEARS YES YES RICHARD A. SHERIFF, R. Ph.

IlUCLEAR PilARilACIST l

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i i CERTIFICATC 0F RA010ACTIVF MATERIAL EXPERIENCE IS0 TOPE ClirMICAL FORit LittlT 125 lodine Human Scrum Albumin 3 mci 125 lodine Snelium lodide 25 mci 131 lodine Sodium lodide ., 400 mci 131 lodine iluman Scrum Albumin 5 mci 131 lodine Macroapgregated Albumin 2 mci 131 lodinc lodohippurote 10 mci 131 lodinc F.ose Bengal 10 MCI 125 lodinc Trliodothyronine 1 mci 125 lodinc Thyroxine 1 mC i 123 lodinc Sodium lodide 10 mci 75 Selenium lie t h ion inc 10 mci 99 Holybderium Fission byproduct 10 curies 99 Molybdenum Fusion byproduct 10 curies 99m Technetium Pertechnctate 10 curies 99m Technetium Sulfur Colloid 300 mci 99m Technetlum flocroaggregated Albumin 150 mC i 99m Technetium Human Serum Albumin Microspheres 150 MCI 99m Technetium DTPA (Tin & tron Ascorbate) 150 mci 99m Technetium Stannicstannous llydroxide 300 MCI 99m Technetium Phytote (Tin) 150 mci 99m Technetium ilumon Scrum Albumin (Electrolysis) 150 mci 99m Technetium Pyrophosphate 200 mci 99m Technetium Polyphosphate 200 mci 99m Technetium Disodium Etidronate 200 mci 99m Technetium Glucoheptonate 100 mci 99m Technetium Methylene Diphosphonate 200 mci 32 Phosphorous Sodium Phosphate 35 mci 32 Phosphorous Chromic Phosphate 5 mci 59 Iron Chloride and/or Citrate 2 mci 51 Chromium Sodium Chromate 5 mci 51 Chrcmien liumon Scrum Albumin 2 mci 197 liercury Chlormerodrin 5 mci 198 Cold Colloidal 20 mci 133 Xenon Gas / Saline 2000 eCi 113 Tin Cencrotor 50 mci 113m Indium Chinride 30 mci 113m Indium liacroaggregated Albumin 25 mci 111 Indium Chloride 50 mci 111 Indium OTPA (Sn) 20 mci 111 Indium itocroaggregated Albumin 10 mci 111 Indium Oleomycin 10 mci 57 Cobalt Cyanocobalamin 2 mci 57 Cobalt' Scaled Source 16 mci 60 Cobalt Scaled Source I MCI 226 Radium Scaled Source 1 mci 137 Cesium Scaled Source 1 mci 14 Carbon - Saline 'l mci 67 Gallium Citrate 100 mci 2 01 Tha l l ium Chloride 10 mci is 81 Rubidium Chloi-ide 3 mci Richard A. Sheriff, R. Ph.

Nuclear Pharmacist

NRC FORM 313M SUPPLEMENT A U.S. NUCLE AR REGULATORY COMMISSION TRAINING AND EXPERIENCE AUTHORIZED USER OR RADIATION SAFETY OFFICER

1. NAME OF AUTHORIZED USER oR R ADI ATION SAFETY OFFICER 2 STATE oR TERRITORY IN WHICH LICENSED TO Frank M. Gwynn PRACTICE MEDICINE Pennsylvania
3. CERTIFICATION SPECIALTY BOARD CATEGORY MONTH AND YE AR CERTIFIED A B C Pharmacy-Certificate # RP-031774L September 1981
4. TRAINING RECEIVED IN BASIC RADIOISOTOPE HANDLING TECHNIQUES TYPE AND LENGTH OF TRAINING LECTURE / SUPE RVISED FIELD OF TRAINING LOCATION AND D ATE (S) OF TR AINING LABORATORY LABORATORY A B COURSES EXPERIENCE (Hours) (Hours}

C D

a. R ADI ATioN PHYSICS AND University of Southern combined total 85 iNSTRuME"'^ "

California, Los Angeles 2/ 21 / 83 -

3/25/83 same as above combined total 45

b. R ADI ATION PROTECTION
c. MATHEM ATICS PERTAINING TO same as above Combined total 20 THE USE AND MEASUREMENT OF RADIOACTIVITY
d. R ADI ATION BIOLOGY same as above combined total 20
e. RADIOPH ARMACEUTICAL same as above combined total 30 CHEMISTRY
5. EXPERlENCE WITH RADIATION. (Actualusr of Radioisotoper or Equivalent Experience)

ISOTOPE MAXIMUM AMOUNT WHERE EXPERIENCE WAS GAINED DURATION OF EXPERIENCE TYPE OF USE see at-; ached list RadPharm, Inc. 160 hours0.00185 days <br />0.0444 hours <br />2.645503e-4 weeks <br />6.088e-5 months <br /> Radiopharmacy dispensing and manufac-turing i s NRC FORM 313M Supplement A 1941: Page 5

NRC FORM 313M SUPPLEMENT A U.S. NUCLE AR REGULATORY COMMISSION TRAINING AND EXPERIENCE AUTHORIZED USER OR RADIATION SAFETY OFFICER 1 NAME OF AUTHORIZED USE R OR RADIATION SAFETY OFFICER 2 STATE OR TERRITORY IN l Barbara D. ScavullO WHICH LICENSED TO pR ACTICE MEDICINE Pennsylvania

3. CERTIFICATION i SPECIALTY SOARD CATEGORY MONTH AND YE AR CE RTIFIED A B C Pharmacy '

December 1982

4. TRAINING RECEIVED IN BASIC R ADIOlSOTOPE HANDLING TECHNIQUES TYPE AND LENGTH OF TRAINING LECTURE / SUPE RVISED FIELD OF TRAINING LOCATION AND D ATEIS) OF TRAINING LABORATORY A LABORATORY 8 COURSES EXPERIENCE (Hours) IHoursi c D University Of Southern combined total 65
a. RADI ATION PHYSICS AND '

INSTRUMENTATION 2/ 21/ 83 -

3/25/83

b. R ADIATION PROTECTION
  • ' 7HE UE^ANMEASUREMEN same as aDOve combined total 20 OF R ADIOACTIVITY same as abOve combined total 20
d. R ADI ATION BnOLOGY i e R ADIOPH AR M ACEUTICAL same as above combined total 30 CH E MIST R Y
5. EXPERlENCE WITH R ADIATlON. (Actualuse of Radioisotopes or Equivalent Experience)

ISOTOPE MAXIMUM AMOUNT WHERE EXPERIENCE WAS GAINED DURATION OF EXPERIENCE TYPE OF USE see 11 tached list RadPharm, Inc. 160 hours0.00185 days <br />0.0444 hours <br />2.645503e-4 weeks <br />6.088e-5 months <br /> Radiopharmacy dispensing cad manufac-turing NOC FORM 313M Supplement A

19 81i Page5
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EXPERIENCE WITH RADIATION Isotope Maximum amount 99mrechnetium 8 Curies 125 Iodine 25 mci 131 Iodine 400 moi 123 Iodine 10 mci 75 selenium 1 moi 99 Molybdenum 25 Curies 32Phosphorous 30 mci 51 chromium 5 moi 13kenon 1 Curie 111 Indium 10 mci 57 cobalt 10 moi 137Cesium i moi 07Gallium 90 mci 201 Thallium 150 mci Frank Gwynn abd Barbara Scavullo l

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ITEM 9  : RADIATION DETECTION EQUIPMENT Type of Instruments (Include Sensitivity Window Number Radiation Range Thickngss Use (Monitor, Make & Model No. of Each) Available Detected (MR/HR)

(MG/CM ) Survey, Meas.)

  • Eberline Model E-530 2 Gamma 0-200 30 G.M. Survey Meter with Package Model HP-270 Detector Monitoring Station
  • Eberline Model E-530 2 Beta 0-200 30 G.M. Survey Meter with Area Gamma Surveying Model HP-270 Detector
  • Ludium Model 2200 1 Gamma N.A.

Scaler / Spectrometer with H.A. Sample Model 203 Detector Analysis '

  • Ludlum Model 177 1 Beta 0-500,000 10 Area and 4

Monitor with Gamma Counts / Min.

Model 44-21 Detector Personnel Monitoring l *Eberline Model 909 1 Gamma H.A.

Dosimeter Charger N.A. N.A. .

  • Eberline Model 862 3 Gamma 0-200 N.A.

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Pocket Dosimeters Oose Measurement

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is Or equivalent competitivo nuclear instrumentation ,

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ITEM 9 : RADIATION DETECTION INSTRUMENTATION In addition to the list on the previous page, the following equipment is located in the pharmacy:

.Eberline RM-14 Room Monitor with HF 190 Detector (1) one available Detects beta and gamma Sensitivity Range: 0-Window Thickness (MG/CMg0000

): 1.4 counts

- 2.0 / minute Use: For area monitoring in dispensing and laboratory areas.

Capintec CRC 10R Dose Calibrator: For measurement of patient doses RADX Mark V Dose Calibrator: For measurement of patient doses and back-up for Capintec Dose Calibrator.

Item 9 /4-8-83

b ITEM 10: CALIBRATION OF INSTRUMENTS Survey Meters and Monitors Description These are portable G.M. survey meters and line operated monitors.

Responsibility These instruments are calibrated by respective manufacturers or a licensed, certified individual or company registered with the NRC or respective agreement state. An example of one such company would bei Eberline Instrument Corp.

P.O. Box 2108 Santa Fe, New Mexico 87501 (505) 471-3232 License #: NM-EBE-BL-21 (New Mexico)

Freauency and Procedures Portable survey instruments are calibrated every six months at two points separated by at least 50 percent of each linear scale that is used routinely. An instrument is considered calibrated when the

observed readings are within t 10 percent of the calculated or known values.

B. Radioassav Eauitment DescriDtion This equipment consists of a Scaler / Spectrometer and Gamma Scin-tillation Well Crystal.

Responsibility This equipment is calibrated by the Site RSO.

Freouency and Procedures The Scaler / Spectrometer is calibrated daily against an Iodine-129 reference source, and as required, with secondary calibration standards prepared by the Mallinckrodt Diagnostics Quality Control Department located in Maryland Heights, NO. The Quality Control equipment calibration is traceable to NBS absolute standards.

C. Dose Calibrator Appendix D of Regulatory Guide 10.8 will be followed for calibration of the dose calibrator.

The sources used will be the following Amersham catalog items or similar sources traceable to NBS Standards. <

Cobalt-57 Amersham Catalog # 586172 Cesium-137 586172 B arium-133 586172

  • NOTE: At the present time, the distribution facility in Folcroft.PA uses Mallinckrodt, Maryland Heights, MO for instrument calibration.

The procedures are on file in NRC license number 24-04206-01 or 24-17450-01. (See attached Distribution Center SOP # A-04)

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Item 10/4-8-83

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ITEM 11: DESCRIPTION OF FACILITY I

This facility is a single story concrete block and steel structure  ;

located in an industrial complex. The internal dimensions are 83+ l feet by 24+ feet providing approximately 2000 square feet of work and storage space. Refer to explanatory sketch of facility.  ;

Note: All shielding walls are crosshatched. (Figure I) i The facility is divided into three functional areas. The front area includes a general office and reception area, restrooms and a break area.

The mid-section comprises the Pharmacy area. All order processing and

, packaging is completed in this area. A solid concrete bunker is provided for storage of radiopharmaceuticals and Molybdenum 99/

Technetium 99m generators. An additional wall of concrete provides shielding for the entrance to the bunker. The central location of the bunker assures minimal radiation levels at the exterior I walls of the facility. (Figure II) Shelving is provided at the rear of the bunker to hold the radioactive material. All radio-pharmaceuticals will be stored in their original lead containers.

All Mo-99/Tc-99m generators will be stored in additional lead shield-ing provided by the manufacturers. Additional lead shielding will be provided as necessary. A locking gate provides security to the bunker.

All Iodine-131 Oral Solution dispensing will be done in the enclosed glove box located in the area of the concrete bunker. The glove box is a configuration of lead, plywood, lead glass and formica laminated together. The intake vent to the box contains a 99 97 HEPA filter. The exhaust, which vents through the roof, contains a pre-filter, charcoal filter and HEPA filter. The front of the

, glove box is shielded with h inch lead and contains a 1 inch lead glass window. ,The top and remaining sides of the glove box are shielded with t inch lead. Additional lead shielding will be set up inside for storage of the Iodine-131.

Shielded transfer carts are provided for use in the pharmacy area to minimize exposure to personnel (Figure III). The shielding on the. carts is a " box

  • comprised of lead, plywood and formica laminated together.

All doses "ill be measured in the dose calibrator before shipping.

To transfer rials or syringes of radioactive materials from lead shielding to the dose calibrator, remote handling tongs will be used.

All dispensing (except Iodine-131) will be done in the laminar flow hood behind a lead and lead glass dispensing shield. Gloves will be worn and lead glass syringe shields will be used. Lead storage bins lined with heavy duty plastic bags will be kept in the rear of the laminar flow hood to house spent syringes and vials contaminated with radioactive materials. When full, the bag is labeled and trans-ferred to waste storage. Waste is segregated by half-life.

The rear area of the facility is the warehouse used for material storage. A second concrete bunker has been constructed in this area

(- to house spent Mo-99/Tc-99m generators and radioactive waste.

Shelving is provided in this bunker, as well as a locking door for security. Additional shielding will be provided as necessary.

Item 11/h-8-83

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ITEM 11: DESCRIPTION OF FACILITIES (con't)

The Mallinckrodt facility is located in an industrial complex.

Warehouse space, similar to the facility is located on both sides.

A service drive, providing access to the warehouse runs behind the facility.

A wire " cage" for key drops of incoming shipments is located in the rear of the warehouse area. The cage is constructed of woven wire fencing. The man-door leading to the outside is secured by a double-key dead bolt lock. The door leading to the inside of the warehouse is a woven wire door with a key lock. The cage is not hooked up to the alarm system, however, a motion detector is located inside the warehouse and will detect a violation of the security of that area.

The facility is wired into a local security agency. -

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Item 11/4-8-83

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ITEM 12: PERSONNEL TRAINING PROGRAM Indoctrination Sessions An informal radiation safety indoctrination is provided new radiation workers by the Site RSO during which they are in-structed in good radiation safety practices and issued a copy of the Radiation Proctection Program Manual. (attached)

On-the-iot training Supervisory personnel provide such training for new radiation workers on a one-on-one basis. The duration of this training is two weeks. Topics covered in this training are determined by need.

Continuing Education Site personnel will participate in continuing education regarding radiation safety for at least i hour per month. The training will include but not be limited to the following categories:

a. Basic radiation physics
b. Explanation of the possible hazards
c. Use of restricted and controlled areas.

, d. Use of survey meters

e. Radiation protection
f. Pertinent Department of Transportation regulations
g. Pertinent NRC regulations
h. Rules and regulations of the license
i. Emergency response
j. Locations of posted or available notices

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Item la/4-8-83

t ITEM 13: PROCEDURES FOR ORDERING AND RECEIVING RADIOACTIVE MATERIAI.

1. Authorized users listed on the license will place orders for radioactive materials and ensure that the requested materials are authorized by the license and the amounts requested do not exceed possession limits.
2. Written records of ordering and receiving radioactive materials will be used.
a. Purchase orders will be used for ordering.
b. A log book will be maintained for received products.
1. All radioactive products received will be assigned an internal lot number. This number will be entered in the log book, along with name of product, manufacturer, manufacturers lot number, results of wipe testing done on the package, and total activity received.

3 Deliveries will be made in the rear of the facility to the wire cage. All appropriate shipping documents must accompany each package.

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r k i ITDi 14 : PROCEDURES FOR SAFELY OPENING PACKAGES CONTAINING RADIOACTIVE MATERIAL

-See attached SOPS A-05 and A-06 for procedures followed.

,i-Item 14/4-8-83

1 ITEM 15: GENERAL RULES FOR THE SAFE USE OF RADI0 ACTIVE MATERIALS

See attached Radiation Protection Program l

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ITEM 16 : EMERGENCY PROCEDURES See attached SOPS A-12 and A-13 Item 16/4-8-83

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' t, ITEM 17: AREA SURVEY PROCEDURES

1. All elution and dispensing areas will be surveyed daily with an appropriately low-range survey meter and decontaninated if necessary.
2. Waste storage, all laboratory areas, and adjacent office areas will be surveyed weekly.

3 Wipe tests will be done on all working areas in laboratory, storage and floor areas (corresponding to work areas) on a weekly basis.

4. See attached SOPS A-07, A-08, and A-09.

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Item 17/4-8 A2

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I ITEM 18: WASTE DISPOSAL All radioactive waste will be disposed of by the decay-in-storage  !

method. l l

The decay-in-storage method consists of the following procedures:

Mo-99/Tc-99m generators over 5 ci in activity will be returned to the manufacturer for disposal. Returns will be shipped under D.O.T.

regulations for safely transporting radioactive materials.

Mo-99/Tc-99m generators under Sci in activity will be held for decay in a separate area from other radioactive waste products. These generators may contain long-lived radioisotopic contaminants, there-fore will be monitored separately to ensure decay to background levels.

All products will be held for decay until radiation levels, as measured in a low-background area, have reached background levels.

-All radiation labels shall be removed or obliterated, and the waste will be disposed of in normal trash.

All radioactive products which are to be disposed will be signed off the corresponding batch record or radioactive materials transfer record (for radioactive waste returned from customers for disposal) and segregated by half-life.

All radioactive waste is to be entered in the waste storage and disposal record book with the date, nuclide, and half-life group.

. All waste will be stored in the respective half-life container (box or leak proof bag) which has been properly labeled. After monitoring the waste will be signed out and disposed of in normal trash. A sample disposal record is attached. Each container will be labeled with the same information found in the disposal record. A sample label is attached.

Radioactive materials transfer records and disposal forms are main-tained as permanent records of disposal.

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r i i \ l ITEM 18: WASTE DISPOSAL

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l l Mallinckrodt, Inc. Diagnostic Imaging Services Nuclear Pharmacies  !

will pick up radioactive waste from their customers. Specifically,  ;

only used or unused vials and syringes will be picked up in their '

original shipping containers. Individual accounts will be respon-sible for other waste generated from the use of the radiopharmaceuticals.

The following procedures must be followed for Packaging of Radioactive Waste for return to Mallinckrodt:

1. All vials and syringes must remain in their original, labeled lead shipping container.
2. All shipping containers must comply with D.O.T. regula- i i tions.

3 Boxes must be sealed, labeled, and monitored, i

4. A transfer record (. copy attached) must be completed and signed and accompany any package picked up.

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i The following procedures must be followed for Pick-up of Radioactive Waste for return to Mallinckrodt:

1. Check all documents for completeness,
2. Insure boxes are properly sealed.

3 Insure package is not damaged.

4. Transporter must sign and date " Pick-up" section of transfer record.

5 One copy of transfer record is left with the customer and the original will be filed as a permanent record of the transfer and disposal.

The following procedures must be followed upon receipt of the radio-active waste:

1

1. The package shall be monitored and wipe tested for remov-4 able contanination.

The results of these tests will be recorded on the transfer

2. ,

record and signed.

3 Radioactive waste shall be incorporated into the facility waste disposal system.

Waste storage areas are described in Items 8 and 13 of the radioactive

! materials license application.

Radioactive waste will not be picked up if the packages are not properly labeled and sealed.

Material will be transported in Mallinckrodt's exclusive use vehicles.

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_ ww - w_ -- - - u_ w _w ne pm ,, th=46.s hrs 9 = indicat:2 no cignific:.1 teading chova 5123I,1[ ^nr201T1,67Ca T4= 6.5-78 .

background Cn133xaglalT Tk= 4-9 d39 m > 51Cr 125Ia75Se,57Co Th=19 daus ISOIOPE Th STORAGE DISPOSAL 1 MEIER RDOING I FDIN CF i@STE l

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i REPRESENTATIVE WASTE CONTAINER LABEL CAUTION RADI0 ACTIVE MATERIAL ISOTOPE DATE STORED:

11UNIFER .JXED $

RADIOACTIVE MATERIALS 71UNSEER REIDRD SECTION 1: SHIPPER SECTICN 2: SHIPPED 70 NAME AIORESS RAM Lic #

SEX.TICN 3: CONTENTS Radionuclide Group # Physical Activity Cateoory Transport Index Fom (nci) I-441ite (For Yellow only)

II-Yellow III-Yellow SECTICN 4: RADIATION SURVEY EUR REIEASE SECTIN 5: PICK-UP A. Survey: Surface mR/hr A. Date:

One Meter mR/hr B. Driver:

B. Wipe 7Yst cm C. Perfomed by:

SECTICN 6: DISPOSITION A. Date received D. Date relaa M to R/A Waste B. Survey: Surface mR/hr E. Performed by Che Meter mR/hr C. Wipe Test cm

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IMPORDNT: This is to certify that the above natied articles are properly labeled, and are in proper condition for transportaticri according to the applicable regu-lations of the Department of Transportation.

Authorized Signature Date

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ITEM 19: THERAPEUTIC USE OF RADI0 PHARMACEUTICALS All dispensing of therapeutic and diagnostic doses of Iodine-131 shall be done in the enclosed glove box. Appropriate radiation safety precautions shall be maintained at all times.

Thyroid bioassays will be performed weekly on all persons handling the Iodine-131 and monthly on personnel working in areas where it is stored.

See S0P A-02 for procedures.

All doses will be transferred from the glove box to the dose calibrator via the shielded handling cart.

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ITEK 21 : PROCEDURES AND PRECAUTIONS FOR USE OF RADIOACTIVE GASES As stated in Item 6 of this application, radioactive gases will be received in individually packaged doses which will not be subdivided or repackaged.

Storage areas have been designated in the facility description two concrete bunkers are provided for storage of radiopharmaceuticals.

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Item 21/4-8-89

ITEM 23: PROCEDURES AND PRECAUTIONS FOR USE OF RADI0 ACTIVE EATERIAL SPECIFIED IN ITEM 6b All. precautions and procedures needed are outlined in the Radiation Protection Program and Standard Operating Procedures attached to this application.

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Item 9'2 /h 0 oa

VEHICLE INSTRUCTIONS

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1. All drivers are given radiation safety training.
2. Drivers are instructed to keep as much distance from the packages as possible and to lock the vehicles whenever unattended.
3. The attached DOT regulations are followed.
4. All vehicles will carry an emergency kit consisting of the followings
a. instructions on cleaning up a radioactive spill
b. emergency phone numbers
c. 2 pairs gloves
d. garbage bags (plastic)
e. 4 chux (plastic backed pads)
f. paper towels
g. radioactive warning labels Instructions are issued each driver in the use of the above equipment. All emergency packets are to be kept is the seating area of each vehicle.

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D.O.T. REGULATIONS:

for shipping and receiving of radioactive materials i

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Description of Material Hazard Class: All materials for shipment are classified according to possible hazards associated with that material.

For Example: Class 1 massive explosives. -

Class 2 - compressed gasses (flammable and non-flammable).

Class 6 poisonous or infectious substances.

Class 7 - Radioactive substances.

Class 8 - Corrosives.

After this initial classification, all materials are further classified

' according to characteristics and special shipping requirements for that hazardous material. .

The first important classification for Radioactive materials shipped would be whether they are " Normal Form" Radioactive Materials or "Special Form" Radioactive Materials.

"Special Form" Radioactive Materials are those which if released from a package would present little hazard due to radiotoxicity and little possibility of contamination. *

" Normal Form" Radioactive Materials are those which are not "Special Form" radioactive materials. They are radiotoxic and if released would

( probably' cause contamination. Mallinckrodt ships only " Normal Form" Radioactive Materials.

Packaging Type by Quantity in Ci:

These are maximum allowable quantities per pkg. (in Curies)

Transport Limited Qty Type A Type B Large Qty Group 0.00001 0.001 20 20 1 0.0001 0.05 20 20 II 0.001 3 200 200 III 0.001 20 200 200 IV 0.001 20 5,000 5,000 V 25.0 1,000 50,000 50,000 VI Mali:nckrodt ships only limited Qty., and Type A Qty. We receive up to Type B Qty.

Transport Group by Radiotoxicity of Isotope:

Normal Form Radionuclides are classified according to radiotoxicity and their relative potential hazard in transportation. These are pre-classified by the D.O.T. in the CFR.

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The isotopes that we handle are classified as follows:

I N/A III 5

7 131 g,67 IV Co S7 Cr 51 Fe 59 3,75 Tc 99 P 32 go 99 Tl 201 .

V N/k33 VI Xe Shipping Papers: The shipping description of a hazardous material on the shipping paper must include:

  • a) Shipping name, Hazard Class i.e. RADI0 ACTIVE MATERIAL N.0.S.
  • b) the identification number (preceeded by UN or NA.)

c) the total weight.

d) the quantity in Ci (per isotope AND total).

  • e) destination.
  • f) transport group classifications by isotope.
  • g) a description of the physical and chemical fonn of the material.

h) LABEL CATEGORY EXA: WI, YII i) transport index

  • j) shipper's name i.e. Mallinckrodt
' Those items above marked with an asterisk are pre-printed on the shipping form.

Packaae Marking:

a) The marking of the package must be durable, in english and must be affixed to the surface of the package (or on a label, tag or sign).

b) Any package for shipment in excess of 110 lbs. must have its gross weight plainly and durably marked on the outside of the package.

c) Any Type A or Type B package must be marked as such on the outside of the package in letters at least 1/2" high.

d) Any package for export shipment must also be marked USA in conjunction (iththespecificationmarking. i.e. USA DOT 7A TYPE A (7A is a

, iiox specification-cardboard).

e) ' Any package for shipment having a rated capacity of 110 gallons or o less shall be marked with the proper shipping name and identification number (preceded by UN or NA as appropriate).

i.e. Radioactive Materals NOS NA 9181 Limited Qty. Radioactive Material NOS UN 2910

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Liquid Hazardous Material:

Along with the markings required above, each package containing liquid hazardous materials must be:

a) packed with closures upward

  • b) legibly marked This Side Up or This End Up, along with an arrow indicating direction.

Packaging Criteria: Specification 7A Unless otherwise specified, all shipments'of NF radioactive materials must meet all requirements listed below.

a) The outside of the package must incorporate a feature such as a seal or label which, if intact, will be evidence that the package has not been opened.

b) The smallest outside dimension of the package must be 4 inches or greater.

c) The package must be designed to maintain shielding and leak tightness.

d) Some form of internal bracing or cushioning must be employed to assure that the distance from the inner container of activity to the outside wall of the package remains within the limits for which the package was designed. This also assures that there is no fluctuation in the T.I. as shown on the bar label.

e) Liquid radioactive materials in Type A quantities must also be packaged within a secondary leak resistant vessel. OR f) enough absorbant material must be provided to absorb at least twice the volume of liquid within the package.

g) The package must be free of significant loose contamination.

h) Sur' face reading must not exceed 200. mR/HR. T.I. must not exceed

10. mR/HR.

i)

Testing information on this type of packaging must be maintained for at least one year after the latest shipment.

This last requirement pertaining to D.O.T. testing refers to several stress tests performed on each package design used for Type A materials.

These tests are performed by Health Physics and in order to pass there must be no release of radioactive materials and no degradation of packaging. Examples of these tests are:

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a) exposure to extreme heat and cold (8 hrs. each) b) vibration tests resembling 1,000 highway miles of travel.

c) water spray test d) compression tests (5X the package weight) e) drop tests (30 ft. for liquid sources) .

Limited Qty. of Radioactive Materials:

Small quantities of RAMS are sometimes exempt from specification packaging, marking, and labeling, if the following conditions are met:

a) RAMS are packaged in strong tight packages preventing any leakage.

b) the outside of the inner container must bear the marking

" Radioactive". .

c) the surface dose rate at any point does not exceed 0.5 mR/HR.

d) there must be no significant loose contamination on the exterior of the package.

e) The quantity in Ci must not exceed:

0.01 mci Group I radionuclides 0.1 mci Group II radionuclides 1.0 mci Group III, IV, V, VI radionuclides 25 Ci Group VII radionuclides

, If any one of the above conditions cannot be met then the materials cannot be shipped as Limited Qty.-Radioactive Materials N05, and must be packaged, labeled, tested and marked as a Type A quantity.

Labelino Requirements for RAMS:

a) A Radioactive White I label must be used on each package measuring 0.5 mR/HR or less on the surface of the package unless the Quantity and Transport group requirements are met for Limited quantity shipment.

b) A Radioactive Yellow II label must be affixed to each package measuring more than 0.5 but not m're than 50 mR/HR on the surface; and not exceeding a T.I. of 1.0 mR/HR.

c) A Radioactive Yellow III label must be used on each package

  • measuring more than 50 mR/HR at the surface and/or exceeding 1.0 mR/HR T.I.

The following information must be entered in the blank spaces on the Radioactive label by legible printing using a durable weather resistant means of marking:

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Page 5 a) Contents - the name of the radionuclides, in order of radiotoxicity as space on the label allows.

b) Amount of Activity in Ci, mci or uCi.

c) Transport index.

Overpack Requirements If an overpack is used to consolidate individual packages, the packages must comply with the packaging, marking, and labeling requirements listed above. Also:

a) The " number of curies" entry on the label must be determined by adding together the number of curies of the packages contained therein.

b) The " contents" entry on the label may state " mixed" unless each inside package contains the same radionuclide.

c) The " transport index" must be detemined by adding together the transport indexes of the packages contained therein.

Transportation Controls:

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a) flo person may offer for transportation aboard a passenger-carrying aircraft any single package with a T.I. greater than 3.0 mR/HR or a surface measurement greater than 200.0 mR/HR.

b) No person may offer for transportation aboard a passenger-carrying aircraft any radioactive material unless it is intended for use in research, medical diagnosis or treatment.

l Any package offered for transportation by air that exceeds the above c) limits must be labeled with a " Cargo Aircraf t Only" label.

d) All RAlis for shipment must be packaged so that the surface reading does not exceed 200 mR/HR and the T.I. does not exceed 10.0 mR/HR except when transported on an " exclusive use" vehicle. There is no Aircraf t consigned as " exclusive use".

Maximum limits for an exclusive use vehicle are as follows:

. a) T.I. from any package must not exceed 1000. mR/HR.

l b) Surface reading must not exceed 200 mR/HR at any point on the vehicle.

c) At six feet from any point on the vehicle the survey must not

( exceed 10 mR/HR.

d) At any occupied position on the truck the survey must not exceed 2 mR/HR.

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I EMERGENCY PROCEDURES FOR RADIOACTIVE SPILLS l

i i

f j In Case of Emergency l

) Or if driver is unconscious call the Radiation l

, Safety Officer at (enter facility phone number) j i

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arergency twW for Nadioacu.m Spuw3 C

IF ' HIE SPILL IS W A PER90N J.. msh the containated area twiately with soap,mter and a hand brush for two to three minutes.

2. Notify the RSO-Radiaticm Safety Officer for Mallinckrodt at lenter facility number).
3. If any clothing was ecntaminated, remove all affected clothing and place it in a plastic bag for GimudJuninaticn. Give this bag to the RSO.
4. Before you return to meks
a. You mst be acnitoced by the RSO
b. hke a sur L of the incident to the RSO IF 'IHE SPILL IS IN AN AREA OR ON AN APPARA20S .
1. Notify the RSO before attenpting to deocntainate the area.
2. Appets ocnfine the spill to its original area.

Take note of all people and e Lus e in the area at the time of the spill.

3. Doctntainate as soon as pr=4Ma to insure better results.
4. Maar disposable gloves during decentmination. If the spill as a liquid, blot up -= with absorbent paper towels. If the spill was A, blot with a dampened paper towel. Do M7r RJB

'mE AREA-this will cause the spill to spread.

5. ni m of any ocntminated paper towels in a plastic bag.
6. Place any doctntainatable objects in a plastic bag for acnitoring by the Rso.
7. Decent minate the area using sono p er and anall amounts of

- water working fran the outside to the miM1a, blot to dry.

( 8. men finished ash your hands as = par ified above.

9. Before returning to work in the affected area:
a. All Wimuu.El in the area nust be acnitored for contaminaticn
b. 'Ihe area must be acnitored by the RSO, the plastic bags ocntaining contaminated naterials nust be renoved, and the area anst be ser+ified as safe by the RSO.
c. 'Ihe perscn nost directly related to the apill must make a written sur.u.L of the incident to the RSO.

N7IE: NCNE T E ABOVE PIOCEIXJRES SEIED BE DCNE BY AN INQUALIFIED PER9CN WI'INITI (INDCTING 'IEE RADIATICE SAFE 1Y TFICER.

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