Text

Package Consisting of Enclosures III, Summary of Nature of Departures from Radipharm Package Inserts Made by Medical Licensees, & IV, Departure Requests, from J Glenn to Usfda & 10CFR Parts 30,32 & 35
	ML20126L573
Person / Time
Issue date:	05/05/1992
From:	Glenn J; NRC
To:	;
Shared Package
ML20126L440	List: IA-92-279, Package Consisting of Enclosures III, Summary of Nature of Departures from Radipharm Package Inserts Made by Medical Licensees, & IV, Departure Requests, from J Glenn 920505 Ltr to Usfda & 10CFR Parts 30,32 & 35; ML20126L437; ML20126L573;
References
	FOIA-92-279 NUDOCS 9301080067
	Download: ML20126L573 (67)
	v • d • e

._-

6 1**

u page 1 of 2 Summary-of the Nature;of Departures from Radiopharmaceutical Package Inserts Hade by Medical Licensees P-32 Used for indication which was not included in the-package inserti indication defined as over production of blood-platelets Xenon-133 Dissolved in saline solution Technetium-913 cardiolite Used activity greater than the package insert maximum for preparation Volume greater than suggested in package insert ceretec Used for labeling leukocytes (not specified in the package insert)

DTPA Used for gastric emptying (not specified in the package insert)

Used activity greater than the package insert maximum-for preparation Extended expiration time beyond that indicated in the package insert MDP Used activity greater than the package insert ^ maximum for preparation Added ascorbic acid MAA Used activity greater than the package insert maximum for preparation Extended expiration time'beyond that indicated in the package insert oxidionate Extended expiration time beyond that 4.ndicated in the package insert

/ C)

Enclosure III A (f

/

12' lu

()

~

9301000067 920721 jf, j,

PDR FOIA FELTON92-279 PDR

k r

page 2 of 2 Summary of the Nature of Departures from-Radiopharmaceutical Package Inserts Made by Medical Licensees PYP Used procedures not specified in'the package insert:

1.

Washed PYP labeled erythrocytes with saline solution and/or 2.

Heat damaged PYP labeled erythrocytes Sodium Extended expiration time beyond that indicated infthe Portech-package insert netate Sulfur Filtered prior to use_(not specified in the package Colloid insert)

Extended expiration time beyond that indicated in the package insert Dosage greater than suggested in package insert

L E

Representative Examples. Providing the Nature of Departures from Radiophannaceutical Package. Inserts Made by Comercial Nuclear Phannacies Enclosnie III B i

-- ~

Syncor Kit Prep Guidelines TABLE 1 :

To9 9 m MACROAGGREGATED A LBUMIN

November 1989 ------

Package Insert -----

Kit Prep Guidelines Recommendations MANUFACTURER Activity' Tc99m Time pf Activity Tc99m Time pr Volume Use Volume Use DuPont 125 aci 2-8 al 12 hours1.388889e-4 days 0.00333 hours 1.984127e-5 weeks 4.566e-6 months 72 mci 2-8 al 6 hours6.944444e-5 days 0.00167 hours 9.920635e-6 weeks 2.283e-6 months (3.6 - 6.5M Particles)

CIS 340 aCl 3-5 al 12 hours1.388889e-4 days 0.00333 hours 1.984127e-5 weeks 4.566e-6 months 240 mci 3-5 al 6 hours6.944444e-5 days 0.00167 hours 9.920635e-6 weeks 2.283e-6 months (12 - 15M Particles)

Squibb 115 aCl 1-3 al 12 hours1.388889e-4 days 0.00333 hours 1.984127e-5 weeks 4.566e-6 months 40 mci 1-3 ml 6 hours6.944444e-5 days 0.00167 hours 9.920635e-6 weeks 2.283e-6 months (2 - 7M Particles)

H:dl+ Physics 50 mci up to 12 hours1.388889e-4 days 0.00333 hours 1.984127e-5 weeks 4.566e-6 months 80 mci 2-8 ml 6 hours6.944444e-5 days 0.00167 hours 9.920635e-6 weeks 2.283e-6 months (1.5 - 2.5M Particles) 3 el (4 - SM Particles)

Hallinckrodt 200 aCl 5-10 ml 12 hours1.388889e-4 days 0.00333 hours 1.984127e-5 weeks 4.566e-6 months 80 mci 5-10 ml discant vial

-(4 - 12M Particles) after 8 hrs

Amounts used _in November 1989 guidelines for MAA based on 200,000 particles per 5 aci dose and average number _ of particles per vial at time ofpreparation.

These values may. be increased to account for decay up to the time of calibration of the dispensed dose.

2 Do not exceed the expiration time of the sodium pertechnetate elution used. to prepare kit.

the

Activity is based on 200,000 particles per 4 mci dose, and minimum number of particles per vial at time of preparation.

of calibration of the first dispensed dose. Activity may be increased to account for decay up to the time

t i

TABLE 2 1 Tc9 9 m BONE INAG ING AGENTS t

November 1989 ------

Packago Insert -----

Kit Prep Guidelines Recommendations l

Activity' Tc99m Time pf Activity' Tc99m Time pf PRODUCT Volume Use Volume Use Squibb HDP 400 mci O.5-5 ml 12 hours1.388889e-4 days 0.00333 hours 1.984127e-5 weeks 4.566e-6 months ' 150 aci 0.5-5 al 12 hours1.388889e-4 days 0.00333 hours 1.984127e-5 weeks 4.566e-6 months ' Medi+ Physics HDP 400 aCl 2-8 al 12 hours1.388889e-4 days 0.00333 hours 1.984127e-5 weeks 4.566e-6 months 400 aci" 2-8 al 6 hours6.944444e-5 days 0.00167 hours 9.920635e-6 weeks 2.283e-6 months DuPont HDP 200 mci 2-8 al 6 hours6.944444e-5 days 0.00167 hours 9.920635e-6 weeks 2.283e-6 months 200 mci' 2-8 al 6 hours6.944444e-5 days 0.00167 hours 9.920635e-6 weeks 2.283e-6 months CIS HDP 200 mci 1-8 al 6 hours6.944444e-5 days 0.00167 hours 9.920635e-6 weeks 2.283e-6 months 200 mci' 1-8 al 6 hours6.944444e-5 days 0.00167 hours 9.920635e-6 weeks 2.283e-6 months Acersham HDP 100 mci 1-8 al 6 hours6.944444e-5 days 0.00167 hours 9.920635e-6 weeks 2.283e-6 months 100 mci 1-8 al 6 hours6.944444e-5 days 0.00167 hours 9.920635e-6 weeks 2.283e-6 months Hallinckrodt HDP

'150 aCi 6 hours6.944444e-5 days 0.00167 hours 9.920635e-6 weeks 2.283e-6 months 150 mci 3-6 al 6 hours6.944444e-5 days 0.00167 hours 9.920635e-6 weeks 2.283e-6 months ' 4

DuPont PYP 200 mci 3-7 al 6 hours6.944444e-5 days 0.00167 hours 9.920635e-6 weeks 2.283e-6 months 200 mci 3-7 ml 6 hours6.944444e-5 days 0.00167 hours 9.920635e-6 weeks 2.283e-6 months Squibb PYP 75 mci 2-4 m1 6 hours6.944444e-5 days 0.00167 hours 9.920635e-6 weeks 2.283e-6 months 75 mci 2-4 al 6 hours6.944444e-5 days 0.00167 hours 9.920635e-6 weeks 2.283e-6 months Mallinckrodt 100 mci 1-10 ml 6 hours6.944444e-5 days 0.00167 hours 9.920635e-6 weeks 2.283e-6 months 100 mci 1-10 ml 6 hours6.944444e-5 days 0.00167 hours 9.920635e-6 weeks 2.283e-6 months

' These activities are maximum amounts and lesser amounts should be used as experience dictates.

2 Do not exceed the 12 hour1.388889e-4 days 0.00333 hours 1.984127e-5 weeks 4.566e-6 months expiration time of the sodium pertechnetate elution used to prepare the kit.

i

' Recommended time of use is not specified in the manufacturer's instructions.

I

' Haximum activity is not specified by the manufacturer.

Syncor policy limits activity to 400 mC1.

Maximum activity is not specified by the manufacturer.

Syncor policy, limits activity to 200 aci.

4

' The manufacturer specifies maximum activity of 300 mC1, but Syncor policy limits it to 200 mci.

The manufacturer specifies maximum activity of 200 mC1, but Syncor policy limits it to 150 mci.

" Manufacturer's instruct ions recommonal an a hoier time of use, but Syncor pol icy Iimit - it t o 6 hoeirs.

TABLE 3 :

ToS 9m DTPA

- November 1989 Kit Prep Guidelines / -

Package Insert Recommendations

'rocedu re Manufacturer Activity Tc99m Time pf Volume Use train Scan Squibb 300 mci up to 5 ml 6 hours6.944444e-5 days 0.00167 hours 9.920635e-6 weeks 2.283e-6 months tenal Scan Squibb 300 sci up to 5 ml 4 hours4.62963e-5 days 0.00111 hours 6.613757e-6 weeks 1.522e-6 months

I

'entilation Study Squibb 300 aci up to 5 al 6 hours6.944444e-5 days 0.00167 hours 9.920635e-6 weeks 2.283e-6 months

FR Acsessment*

Squibti 50 aci 2-5 ml I hour train Scan Medi+ Physics 300 mci

2-8 al 6 hours6.944444e-5 days 0.00167 hours 9.920635e-6 weeks 2.283e-6 months

cnol Scan Medi+ Physics 300 mci 2-8 al 6 hours6.944444e-5 days 0.00167 hours 9.920635e-6 weeks 2.283e-6 months

'entilation Study Medi+ Physics 300 sci

2-8 al 6 hours6.944444e-5 days 0.00167 hours 9.920635e-6 weeks 2.283e-6 months FR Assessment

Medi+ Physics 50 sci 2-8 al I hour rcin Scan CIS 100 mci

2-3 al 2 hours2.314815e-5 days 5.555556e-4 hours 3.306878e-6 weeks 7.61e-7 months

cnni Scan CIS 100 aci*

2-3 al 2 hours2.314815e-5 days 5.555556e-4 hours 3.306878e-6 weeks 7.61e-7 months #

cntilation Study CIS 100 mci

2-3 al 2 hours2.314815e-5 days 5.555556e-4 hours 3.306878e-6 weeks 7.61e-7 months #

3 FR Acsessment CIS 50 mci 2-3 al I hour Do not exceed the 12 hour1.388889e-4 days 0.00333 hours 1.984127e-5 weeks 4.566e-6 months expiration time of the sodium pertechnetate elution used to prepare the kit.

Syncor guidelines are more restrictive than manufacturers' instructions.

l Syncor experience shows that Med1+ Physics DTPA is preferred for GFR assessment.

TAB LE 4

To9 9 m G LUCOEEPTONATE

- November 1989 Kit Prep Guidelines / -

s Package Insert Recommendations Procedure Manufacturer Activity TcS9m Time pf Volume Use 1

Brain Scan DuPont 150 mci

3-7 al 6 hours6.944444e-5 days 0.00167 hours 9.920635e-6 weeks 2.283e-6 months R:nal Scan DuPont 150 mci

3-7 al 4 hours4.62963e-5 days 0.00111 hours 6.613757e-6 weeks 1.522e-6 months #

' Do not exceed'the 12 hour1.388889e-4 days 0.00333 hours 1.984127e-5 weeks 4.566e-6 months expiration time of the sodium pertechnetste elution used to prepare the kit.

Syncor guidelines are more restrictive than manufacturers' instructions.

TABLE 5 :

To9 9 m EDMAN 8ERUM ALBUMIN

November 1989 ------

Package Insert ----

Kit Prep Guidelines Recommendations Procedure Manufacturer Activity Tc99m Time pf Activity Tc99m Time pf volume Use Volume Use Multidose Medl+ Physics 200 sci 3 al 6 hours6.944444e-5 days 0.00167 hours 9.920635e-6 weeks 2.283e-6 months 100 mci 3 al 6 hours6.944444e-5 days 0.00167 hours 9.920635e-6 weeks 2.283e-6 months Unit Dose Medi+ Physics 70 mci 1.3 al 6 hours6.944444e-5 days 0.00167 hours 9.920635e-6 weeks 2.283e-6 months 30 sci 1.3 al 3 hours3.472222e-5 days 8.333333e-4 hours 4.960317e-6 weeks 1.1415e-6 months

Do not exceed the 12 hour1.388889e-4 days 0.00333 hours 1.984127e-5 weeks 4.566e-6 months expiration time of the sodium pertechnetate slution used to prepara the kit.

,_ -____--- __-_ _ s

TABLE 6 :

TcD 9m HEPATOBILIAEY LIVER AGENTS

Package Insert -----

Novembe r 19 8 9 Kit Prep Guidelines Recommendations Product Manufacturer Activity Tc99m Time pf Activity Tc99m Time pf Volume Use Volume Use Cholotec Squibb 200 mci 2-5 al 18 hours2.083333e-4 days 0.005 hours 2.97619e-5 weeks 6.849e-6 months #

100 mci 1-5 al 18 hours2.083333e-4 days 0.005 hours 2.97619e-5 weeks 6.849e-6 months Hepatolite DuPont 150 mci 2-5 ml 8 hours9.259259e-5 days 0.00222 hours 1.322751e-5 weeks 3.044e-6 months 100 aCi 4-5 al 6 hours6.944444e-5 days 0.00167 hours 9.920635e-6 weeks 2.283e-6 months Microlite DuPont 75 mci 2-8 al 6 hours6.944444e-5 days 0.00167 hours 9.920635e-6 weeks 2.283e-6 months 75 mci 2-8 mi 6 hours6.944444e-5 days 0.00167 hours 9.920635e-6 weeks 2.283e-6 months Sulfur CIS 500 aCl 1-3 al 12 hours1.388889e-4 days 0.00333 hours 1.984127e-5 weeks 4.566e-6 months 500 mci 1-3 al 6 hours6.944444e-5 days 0.00167 hours 9.920635e-6 weeks 2.283e-6 months Colloid Sulfur Mallinckrodt 400 mci O.1-5 ml 12 hours1.388889e-4 days 0.00333 hours 1.984127e-5 weeks 4.566e-6 months 400 mC1 0.1-5 al dis 2xd vial after 6 luu.

Colloid 3

Sulfur Squibb 500 mci O.1-5 al 12 hours1.388889e-4 days 0.00333 hours 1.984127e-5 weeks 4.566e-6 months 500 sci 0.1-5 al 6 hours6.944444e-5 days 0.00167 hours 9.920635e-6 weeks 2.283e-6 months Colloid Sulfur Medi+ Physics 400 aci O.5-5 ml 12 hours1.388889e-4 days 0.00333 hours 1.984127e-5 weeks 4.566e-6 months 400 aCl O.5-5m1 6 hours6.944444e-5 days 0.00167 hours 9.920635e-6 weeks 2.283e-6 months

Do not exceed the 12 hour1.388889e-4 days 0.00333 hours 1.984127e-5 weeks 4.566e-6 months expiration time of the sodium pertechnetate elution used to prepare the kit.

Preservative in formulation allows 18 hour2.083333e-4 days 0.005 hours 2.97619e-5 weeks 6.849e-6 months expiration time specified in package insert.

Tc99m must have Ho99 concentration within acceptable limits as of expiration time.

Manufacturer's instructions do not specify maximum activity.

Syncor policy limits activity to 500 mci.

i.

t I

T A B L E.

7 :

O T'E E R To9 9M IMAGING AGENT 5 l-I f

5

- November 1989 Kit Prep Guidelinpe/ -

I Package Insert Recommendations i

' Product Magnufacturer Activity TcS9m 1

Time pf Volume Use DMSA Medi+ Physics 44-88 mci 2.2 - 4.4 al 30 minutes 2.2 al reagent HM-PAO-(Cerstec')

amerinhan 30 aC1 up to 5 al 30 minutes

[

3 t

t I

' 'syncor Guidelines correspond to manufacturers' instructions.

- Do not exceed 12. hour expiration time of the sodium pertechnetate elution used to prepare the kit.

I

Sodium pertechnetate elution must be less than 2 hours2.314815e-5 days 5.555556e-4 hours 3.306878e-6 weeks 7.61e-7 months old when used to pr epare the kit.

i

+

j.

L

.\\

\\

r 3

a s

.+n

-+

em.,

um,-- - -- - - - -

.,,,,, c o w coue nov.uawon.au e ns

?

i q

I t

To: tanal Anin, 9yncor, Inc.

Ite t l'terarstion of Technetium 99m etTAO--Labeled Leukocytes

eat Mr. Anint This to authorize Syncor to prepare Technetium 99m HIGA9--tabeled leukocytas for use by the Nuclear Medicine Service Department of Radiology at Akron General Medical Center, Akron, Ohio.

These labeled leuxocytes will be used for imaging patients with suspected infection, such as osteomyelitis. Use of tnis product is indicated as a substitute for lil-In leukecytes because of increased resolution of lechnattun 99m and reduced radiation dose to the e

patient, particularly the spleen.

tse was approved at the Padiatien Saf tey Conmittee meeting hold in July, 1991. This authorization is made pursunt.t to CTx 35.M0 (c)(1).

l Lt. 5denard _Albright.

Dir e ctnt, Department et Nuclear Pedicine Akron General Medical Center Post-it* brand fu t'ansmmat memo 7671 (* *'**v"

')

%cm

' % mvc~

Co.

ce Dest.

Phgy

' R$ *= & Q *?3h-__(

)6 $$

LMC k ee D 1 O L U 84 f

&J L P T.

~i4577$714 P, 60 )

e c

EALLINCKRODT Nuclear hiedicine January 23,1992 W11.nckrodt Medwal, Inc.

Air. Rol>en Ellh o., swat sum urma Nuclear biedicine Dept.

S d

R ',", y,,,,,

Lutheran bledical Center g,,,y}U/O 2639 Miami St.

u,,s a m w.ssss St. Louk MO 63118 1

4 g l / 1(

/

g

Dear Mr. Ellis,

D f

p.

Recently the tmC has become interested in the Usue of nuclear pharmac compounding Tce V>n technetium radiophannaceutical kits using parameters other than those nated in the product's padage insen. The NRC is allowing nuclear phannacles to amend their licenses under 10 CFR Pan 30.34 to des 1 ate porn the package insen guidelines only { fit can be demonstrated that the product quality U not compromhed. The Mallinckrodt Dl3 pharmacy cunently prepares your radiopharmaceudcols slightly diferent than the consenutive manufacruters' package insen guidelines. (For spec @c chwsges, see attached shees.) These changes are coruistent uith current standards of nuclear phannacy practice, and quality assurance procedures are perfonned daily. Until the necessary licerue amendment is submined, the NRC U requesting that Mallinckrods haw on fle as the nuclear phannacy a signed author 1wfonfrom the prescribing physician (bl.D. authoristd user)for radiopharmaceutical compounded outside the parameters stated in the package truen.

In onfer to remaln in rtgulatory compliance with 10 CFR Pan 35, n ask you to sign amt return the attached authorizationform Indicating >vur approvalfor radiophannacetaical kitpreparation consistent with current standards of nuclear phannacy pracnce. As always, htallinc.krods is corrnitted to exce!!cnce in nuclear medicine and the sqfety and milbeing ofyour patients.

Enc *osed are rav copies of the authoritationprm. Keep one copyfor your records and return the other copy to Mallinckrodt in the enclosed sel(-addressed stamped enwlope.

Pletue contact me ifyou haw questions regarding this request or wuld like to dUcuss any portion of the cunent regulations.

Sincerely J/

ock Manin.

.Ph., BCNP Tacility Manager Enclosures df.2J 2' s

< m... nim w..

u..,.

9 4

i mal.LINCKRODT MEDIC AL, INC.

ST. LOUIS DlS

.-. n..flMPA' IOPOAP'. 6CWnCAL PRERA1WlQt.L.Grx.j ; N :.* r; Ti n---**: r m (i..w.m 5,rvrir~I IDEElfjE:

g

.w. 2,

i 6.

D s....

r..'. i,.,s.~ n, n..c..... e..

1.a,.

.,,M,DC..d,J. i,M, B f g T5t,ri.:{*

~

.. x v..,.=.

i M~.t. %w;..

m e, f,6_ C6.4.,G41td>fR.T... t;i, F E

.. - G.. #,.q.M.,,

A

,. v.i. *.'f.,

i

.?.

t y,__

.c R A Of O P (.I i n

,s 5EtE ilQA 'XAN@Y7Y}[K:.T.?.!?OT.f. m wg.C'T','

u w

.hL ryww::

, M,'t. T6 Ul r u )e3 bqg u.p!? Ny 4.s 2'yy UMi 2 9 iP8C ?l-mx s-V?

tJ

<ge' L.' gyEh3 Ij e

a anu 1'3 N'3;E 15@b.,;(f;D-ow,-u.4 l:.%m. tlc t

~l W!

m

. Mnd ;i.g;r.3 y 9*-N.,.www Aw;, c:T-. W /J.ct: t-JJ'O W3?M i?f f A '. :

K pl:

M'

.I.~p 2 3 2i:. A.rde.

F

%mx, c _

.n, nn, wme w-

~ + r enn=a rr ~

rurs

% t tm S UL Aim C c4 Cup 500 4

MA 100 12 Teatm sta A 60 8

84 4 160 10 TpSimRADP W

64 4 325 0

Smg setortWe amad it,89m DTPA

.0-8mp assertwo e.ed 10 0

C r$

3CC to te ttm 0WCUT Aff M

8 MDA 100 0

to t am P#

iCO 8

MM 300 7

Te Pim hbp 200 8

MW 748 9

Ts tem lug) 1,.00_-

..~

.._.. 100 10 8

A44 fellm RS A 100 0

MM 175 8

12 W4 24 T e t t m k e PER ? ! CW4t f A f t

. n ~ _.n

~. -

--~ ~

~.w w w

~.u n.e_

~.,_ w a= = =-- -

Nets.,A R oths/ red:c@ertr.eceutical.?s are prepared accordog to manuf acturet package insert gum 4Arws.

DiYElALLAVIHOBJZM10N l hareby grant approval for Mallinckrodt phermecists to oxorcise their professional judgement in the i

prepau tion of radiophermacouticalkits consistent with the standards of practice of nuclast phermacy as detailed under MMI DIS pharmacy preparation guidelines on this page.

l Hepital Name:

ini.,s7uw 2<rnic A1, cgstu t

Physician Egnatura:_,_

[ddw,

h fd(.x. w.,_h'O I

Date:

IA 28 l92

a 1

i I

l e

i 1

I

?

Departure Requests 4

+

r h

V Enclosure IV 1

e

]

N L

,a-

,,y,...

3

--,y,--

ww,e~,

..,._,,,e.-g %,,n.

7

- - -w +s - v-ve w.., v. r w w,4 so-

,.w-,,

,..-,,,.---,,,w.

w--

,,m.

.,.---,6-,

. i 8

g i

DEPARTURE FROM MANUFACTURERS INSTRUCTIONS TECHNETIUM 99m SESTAMIBI the instructions for Carciolite, the Tecnnetium Sestamibi procuct et Uccent calls for tne aedition of d5-IS0 mC1 of technetium to the supp1ted vial.

After discussion with a number of centers using the Settamibt agent, it is quite separent that over 200 mC) of technetium can ce instilled into the vial withcut degrading the tagging of the tracer.

The cost for Technetium Sestamtoi per patient is determine by -the nuineer of patient doses obtained per vial.

By increasing the technetium placed in the vial from 150 to 22S mci and to a volume of A ccm, it is possible to cut the cost of the material substantially resulting in a health care benefit to the general population. Consequently, I am recommending a departure from the package insert with m) allowance for up to'225 MCI and 4 cc of technetium to be instilled per vial of Sestamici.

R JL AL

[

/

s g 1*

e b

?

+

g p-F-e, w'gg,y ww.

y-g

.ywrnp(_% ve.W 6eywme.ye,-+e

.y1-+M rr e-ramy-c-,-enpgq q n y-gg 3 p.-egr-g-y s79 t m

eit--

p y

--w-,

y yqg-egpaie,-eg--9 mes-e w

-M+r t

DEPARTURL FROM PACKAGE INSERT P-32 THERAPY FCR THROMBOCYT0515

ntra4.eous acueous P-30 hst teen sh:wn recenteoly to be of tenefit for 03tient5 with overproductiCh of blood collt by the DCne marrou.

it is Ora of tre major treatment $ given (cr patients with polycythemia vcra, for unom the other the*aples incluce phlebotomy arid ChemCtherapy, in some patients the enly owerproduced element is the bloco platelet.

For these individuals phlebotomy 15 not a trerapeutic Cption but P-32 has proven to be of grest benefit.

Consequently, as a principle user of therapeutic racionuclides at f he Villiamsport Hospital L Medical Lenter, I authorite the use of therapeutic acucous P-32 for this indication, n

Q L GA w w

/

Y*\\

k

I WRITTEN DIRECTIVE FOR DEVIATION PROM MANUPACTURER'S INSTRUCTIONS FOR A RADIOPitARMACEUTICAL Date:

January 3, 1992 Patient Names SEE LIST Patient __ SSN:

SEE LIST Specific Nature of the Departures This is a written directive to deviate from the manufacturer's instructions concerning the amount of activity that will be added to all Cardio11te xits.

Precise Description of the Departures When reconstituting Cardioitte kits, add a total activity of 300 mC1 to each kit lastead of the recommended 25-150 mci.

All other parameters including *rolume of reconstitution, expiration time, and method of quality control will be performed as instructed by the manufacturer.

Reason fof the Departure:

This deviation will allow us to obtain more patient doses from one vial.

Therefore, the benefit to the patient is in terms of cost savings.

Since there are no effects on product quality, radiation dosimetry to the p'attent, or any other test parameters, additional risks,to the patient as a result of this deviation are nonexistent.

A

)

1 % f fk)J, b p I' D 5

s Authorized IJser Physician Signature

D" C'! M E !;T A T I O!1 Dr DE*/IATION FROM PRESCRIBED DOSE AS PER FACTACE !!!! E F T I,

,.) *:/'07 c1 j

i n

s'u fx*jf,'/j 1r.

_l~

fI

)fpt E C A:; x

~

.', r /f PHYSICIAN:

'ti/ -

//

DATE:

FATIENTi_ 1(#

[_

tr sl ADMINISTERED DOSE:

/

2"

/t

-3 d it /' > /

I!/ M

/

l' y

/ -

INDICATJPs_hh);fhft*

0 k

. ~fy.n!, f[ ;, t O f /*( t* 1J ' (

C INICAL

/

L J

[

,1 uC1 DEVIATION FROM SUGGESTED D O S I: 2

+

PER THIS RADIOPHARMACEUTICAL Circle PACKAGE INSERT

~~

'/

C:u g M.D.,RSO f

Michae1 T.

,. a 1r.y r>u.

I l

7/01/91 Revised S/01/91 EXEMPTION TO PACKAGE INSERT FOR SAME DAY STUDIES USING TECIINETIUM 99M CARDIOLITE 1

Sestamibi (Cardiolite) is a new technetium based compound for myocardial perfusion imaging.

Technetium energy and lack of significant redistribution make this an ideal perfusion imaging agent particularly f or use with SPECT imaging.

However, one of the major advantages of this new compound is that it allows first pass evaluation of left ventricular function both at rest and stress providing significant important prognostic and diagnostic information in addition to the perfusion image with the same injection of radiotracer at the same dosimetry.

This is one of the major advantages leading to its utilization at the Medical College of Virginia and partially justifies its marked increase in expense.

However, unlike Thallium-201, it does not redistribute and two injections of tracer are required either on the same day or on

, separate days.

To perform quality, valid first pass studies the bolus must not exceed 0.5cc and the smaller the bolus, the Better.

In the case of two day studies adequate specific activity to allow this is not problematic;

however, in the single day protocol pref erred by both patients and referring physicians, a low dose (10 mci) rest study is followed by a high dose (30mC1) stress study performed several hours later.

The vendor permits six doses per vial wi'th a shelf life of six hours f ollowing preparation; however, the package insert recommends 1 to 3 milliliters of volume containing 25 to 150mC1.

In order to perform same day studies with first pass on three patients (6 injections) which is the minimum feasible number considering the cost, the recommendation is not cogent.

A minimum of volume of 2ml is necessary to provide the six injections and to provide adequate activity for the 30 mci late doses at the shelf 1:fe projected by the vendor would require that the initial activity be 120 mci per milliliter.

Therefore for same day studies with Cardiolite it is necessary to prepare kits with up to 250 mci in a vial with a volume not to exceed 2. 5ml.

With this exemption alterations in QC will be performed to ensure the stability of the compound before-being injected.

Although the initial QC will be performed as recommended a second QC will be performed prior to the late injections of the tracer (ie., the second stress high done ' injections) and at the expiration of the kit.

The following exemption appears reasonable and in the best interest of providing quality patient care.

Single day first pass rest / stress studies are optimal for providing the maximum information for the dose administered.

It should be noted.tha pAtle_Rt dele has not-been changed apd is_ within the recomm,qnded sluidelines of the = nackage insert.

There is no evidence-to support that this change in kit preparation changes either the stability or binding efficiency of the compound in any way and that the limitations are primarily of commercial origin.

We have observed

no problems with stability or binding in-kit preparations in wnAcn doses have exceeded that suggested.

In addition, QC vill be strictly followed so as to detect any change in binding efficiency or stability and P ts will not be used where the QC degrades by 5%

or greater from e initial QC or if any of the QC's exceed that recommended to eu lization by the commercial vendor.

Jamps./[a #

Tptum, M.D.

Di actor of Huclear Cardiology 0

ration Director vision of Huclear Medicine

u -

y-

.g St. M

.. pn.il.md Wdh.el G nf. 4 II L(J30 i.

c...

Dato:

January 22, 1992 vo:

Nuclear Medicino Personnel From:

1.dwa rd it. Powr.ner, M.D.

Subjoct.:

Preparation of Technotium-99m Sentamibi NitC regulationn require that radiopharmacouticals be prepared according to the manufacturer's instructions except in those instances where the desired medical renults would not bo otherwise obtainabic.

T,pecifically, Du Pont/flEll instructionn for Cardiolite (nestamibi) recoinmend adding 2 5 to 150 mci of sodium pettechnetato technetium-99m in 1 to 3 mt.

The following chango i n a u t h o r i ;'.e d :

Technetium-99m sentamibi is to be prepared with up to 370 mC1 of technetium-99n.

The purpose of this change is to allow the radiopharmacy to dir. pense the recommended 30 pCi per patient so as to complete the rent / ct renn r.tudy in one day inr,tead of i n two days.

This reduces the length of stay for inpatients and eliminates the two-day study for outpatients.

Chromatography inconvenience of a of the kit prepared this way has repeatedly confirned that there is 95 to 96% radiochemical purity at 6 hcurs post-calibration.

,N

/

)

f

/

.we %

3 4

--r A

as,a t

o i

r I

l i

i MEMOhatibOM

<v:

?D uc!5 d MEDICItJE PHYSICI Atl STAFF i

F F.vM : hADIOPHAkMACliT JUPJ: PREPALATIvtl 0F TC99M CAEDIOLITE I HAVE DETERMIt1ED THAT Ot1E VI AL cat 1 ' HOLD" UP TO 9".' MILLICURIE.. vF TC99M AtJD Malt 4TAIN A TAU OF vvEh 9% (1P -TO 5 HOUhS POST PhEPARATICli.

THE PACKAtiE ItJSERT QNLY ALLOWS UP T0 lbu MCI To PE ATDED PER VIAL.

THE tihe WILL' HULD US TO THAT

^

LIMIT OF 15v MILLICURIES PEh VIAL UtJLESS'WE AT.cE THE'll SPECIFIC f4ATURE OF THE DEPARTURE FROM THE PACKAGE INSERT. 2 i A PRECISE DESchlPTION uF THE DFFAFrURE AND 3 ) A BRIEF STATEME!JT UF THE REASONS WHY THE DEF AhTUH:

FROM THE PACKAGE INSERT PhEPARATIO!JS If4SThUCTIONS WQULD v8 TAIT 1 MEDICAL RESULTS IJ0T OTHERWISE ATTAI!JABLE OR WoVLD EEDUCE MEDICAL hISKS TO. PARTICULAR PATIEt1TS BECAUSE OF THElk MEDICAL CONDITI0ti.

ACCORDINdLY I WOULD LIKE TO HAVE THE STAFF FHYSICIANS SIGt4 vFF Ot1 THE FOLLOWING STATEMEt1T.

THE RADIOPHARMACY WILL MEEP A RECORD OF THESE PATIENTS FOR FIVE YEARS.

3 I AUTHORIZE THE ADDITION OF UP TO 3vu MILLICURIES OF TC99M' PER VIAL 0F CARDIOLITE T0 REDUCE THE COSTS OF UTILI"ATIOtl 0F THIS RADI0 PHARMACEUTICAL IN PLACE OF THALLIUM 001. THId kEDUCT!0N'IN COST WILL ENABLE'THIS MEDICAL CENTER TO USE

-THIS m3Et4T WHICH WOULD BE Ph0HIBITIVE UNDEh <!URREt1T B U L*J E T A R Y R E S T R A l t4 T S,

v

=-

-~..--.;

-.-.-.-.-.....-...-... a. - -

r-L j

1

....,... c......s.

, n...f rr '. w f ;; wr r '

ag;eitec 3 :'. e t. e

. :;.., 3 ; t s n.O.

i??ra :rNI:te

'50

? 6.'

~....

The listed radicph3rmaceutical h3s passed radiecnemical cual tw

.ntre!. historically with13beling ef f tciencWsof 95-99.5

. reference the dally charmaceuttcal auslity control sheets).

The agent is prepared St high concentrations because be!us

njectiens of this compound is reQulred for the majority of the

11n: c31 studies that use it. Injected volumes of less than 0.5 mL

cntair.ing 15-20 mC1 are needed for statist!cally adequate im3ges I d (Tp Q;.

} h t i,,

N gh

\\

('

Jerr Kight,M D.

Director, Nuclear Medicine Methodist Hospit31 of Indiana i

InTi3nsp0!is,1N l

.f i

l l,

i k

i 1

I i

.' 1 1

~

l l

i 1..

M

r.

a,

' *, + *'y**')*,

=

-r y,: ; m.; c..

.;3 m a;

.m r.'3:*.ur v )

Ev; gene 1:t ' 1:o mroca ?:-

riAN-0TPA MO 300 c

..ic,

~.

Tt+ htted radiocharmaceutical has passed radiochemt:3!2::!' -

r.trci.histcrically with labeling ef ficiencies of 95-99s

/eferenci the daily pharmaceutical avality control sheets).

The agent is prepared at high concentrations because bolut

'njections of this compound is required for the majority of the clinical tudies that use it. Injected volumes of les5 than 0 5 mL ccntaining 15-20 mci are needed for statistically adequate images.

e,

(

f

't e N

{

~

Jerry Kight, M D Director, Nuclear Medicine Methodist Hospital of Indiana mdianapolis,IN

++4nk we p.

y

,,4e 3

e w r ' F e'-

W C

='*-'*Y t*

+**

8**e'ee*'vw

r"

~*www'**->*-

-*---*w-w'+'e*-We 46*W--w-*

y

.m

.,,..,,.(,,-ri.

r,+...,.

.,,.,... [, w g

.~

't"._

_...?,,

The heted r3dictbarrr,3ceutic31 h3s D35 sed r3dlochemical Ot.W-ccntro!,h:stor:c31 y with labelingef ficienciescf 95-99E Peference ',he callc ;narm3ceutica! quality :entrci sheeh)J The a;er;t is treoared at nichccncentraticos because t;elue m;ecticr.s of this ccrnccuna is requi.ad for the inajor tv ;f the chn: Cal ihd'ts that use it. Injected volurnes of less than E5 rnt.

c:rtaining 15-20 mci 3re needed for st3tistically adequate irnages 1,

L

\\1.

j\\.

l

\\b\\ 's h ^ (..(,f

' ~ " -L W.

i]

N Jerry Eight, f 1 D.

Direc tor. Nuclear Medicine Methodist Hospit3l of Indiana inctanapolls,IN mW

1 7 int..t.,.

3:

r 3:e:

Y f3:D.c + r

v;;e :Ie') 3 : *. :"I'l ;

+L ?. *. P s v a.

" ' v.":'r.1 ic o e

~

h5ted radiopharmaceutical has Dasied rac10 chemical aval!!v nt

or tr:1.h): toric 311y with labeling ef ficiencies of 95-995

re'erence the daily charmaceut cal cuality cor.tro! sheets).

l The aaent ts prepared at high ccncentraticr.3 Decause Delus

'r.;ect1:ns cf this compound is recu: red fer tr,e magrity of the

!!nt;al stuates that use it. Injected volumes of less than 0 5 mL containirta 15-20 mCf are needed for statistically adequate images l

I (3 (

s I

i

~,341gv\\

( y; j'n N

t -

l Jerry Kight. M D.

Director, Nuclear Medicine Methadist Hospital of Indiana Indianapolls,lN

=

MALLI CKRODT

!TMO,Lo INSTITUTE OF RADIOLOGY A r WASSGON tM EMrfY MWlCAL LMlU i

5 November 1990 To:

Radiation' Safety Officer 1

Nuclear Medicine Professional and Technical Staff 2

From:

Barry A. Siegel, M.D.

Sally Schwarz, M.S., R.Ph.

Re:

NRC Interim Final Rule on Radiophannaceutical Preparation and Therapeutic Uses of Radiophannaceuticals An interim Onal rule issued by the NRC on 23 August 1990 modifies 10 CFR Pans 30 and 35 to pennit (1) cenain deviations from manufacturers' instructions for elution of genera-tors and preparation of radiopharmaceuticals and (2) for deviations from therapeutic indica.

tions specined in the package insen. Such deviations are pennitted at the instruction of an authorized user physician if they are expected to allow specine medical benefits. De rule also imposes the requirement for a written directive (i.e., a prescription) made by an autho-tized user directing a specific departure for a panicular patient, or patients, or for a radio.

- e phannaceutical, and which includes (1) the specific nature of the depanure; (2) a precise description of the depanure; and (3) a brief statement of the reasons why the depanure from.

tiie manufacturer's instructions would obtain medical results not otherwise attainable or would reduce medical risks to panicular patients because of their medical conditions.-

Ordinarily, such a written directive would be accomplished generically (see below) or specifically for a panicular patient prior to the procedure. : An oral directive is acceptable -

under emergency circumstances, but the rule requires that the written directive must be completed within three working days of the emergency administration. The rule also requires that we maintain records of such depanures from manufacturers' instructions in-an auditable form for a period of Ove years.

5!0 South Kmpshighway Doulevard St Louis. Missouri 63110 010 362 2RN c.. -.

_.,.._.._...._u.__._..,n..

-__._,,...,.,,.r.

u uw.c wot osi n t U. 0b R ADloL(XiY 5 November 1990 page:

I At the present time, we are not aware of deviations in the indications for therapeutic radio-pharmaceutical administrations in the Division of Nuclear Medicine, since our sole thera-peutic prceedure is the administration of I 131 sodium iodide oral solution for treatment of hypenhyroidism.

Attached is a copy of a new " prescription" form to be used when depanures from estab-lished procedures are requested by an authorized user. Completion of this fomt will be necessary only for those depanures from established procedures that are not aheady codi-fled in the Division's Clinical Procedure Manual and/or Radiopharmacy Procedure Manual (see below).

De following represent deviations from nunufacturers' package labeling in the preparation of radiopharmaceuticals that are established procedures of the Division documented in the Clinical Procedure Manual and/or Radiopharmacy Pmcedure Manual, and already in effect as of 23 August 1990. This memorandum serves as formal notification to file and to the Radiation Safety Committee of deviations in radiopharmaceutical preparation. (Note that, for the sake of completeness, deviations involving non byproduct material are included in this listing, although these are not subject to the NRC rule.) Tracking of the numbers of 1

these " established deviations," as required by the NRC, will be simply accomplished by keeping track of the diagnostic codes for these procedures by way of the MIR accounting system.

A',

Tc 99m Macroaggregated Albumin (Mallinckrodt) 1.

Specific Nature of Depanure: Removal of 1/2 of vial contents before com-pounding and increase the ratio of added Tc 99m penechnetate to mass of macroaggregated albumin.

2.

Description of Depanure:

a.

Withdraw 1/2 of vial contents after reconstituting lyophilized pani.

cles with 1 mL 0.9% Nacl, USP.

b.

Add 60 mci Tc 99m penechnetate to vial.

c.

Use kit within 3 hours3.472222e-5 days 8.333333e-4 hours 4.960317e-6 weeks 1.1415e-6 months (instead of 8 hours9.259259e-5 days 0.00222 hours 1.322751e-5 weeks 3.044e-6 months ).

-,..w.--------.

.e-n----,-e----

w a.-,---

.-,a

, - -,,,-~

..-r-,

,,e,,,

,-wma---,-

-n.,

,r-,,

r

-v,,,

,7----,-----,-,m

+- r

--v

.. ~. - - - -. -

7 u t r,cuOor in1 riin H OF R A DIOl.OW 5 November 1990 Pace 3 l

i 3

Rationale: Pennits panicle number of administered panicles to be main.

I 5

5 tained in the range 2.6 x 10 to 4.7_ x 10 per 4 or 5 mci dose of Tc 99m MAA. This is necessary because of the large fraction of our patients with

. underlying severe parenchymal pulmonary disease or pulmonary hypenen-sion.

II.

Tc 99m Macroaggregated Albumin (DuPont) 1.

Specific Nature of Depanure: Add 80 mci Tc 99m penechnetate to vial (instead of 50 mci).

2.

Description of Depanure:

a.

Add 80 mci Tc.99m penechnetate to vial.

b.

Dilute total vial to 8.0 mL using 0.9% Nacl.

c.

Use kit within 3.5 hours5.787037e-5 days 0.00139 hours 8.267196e-6 weeks 1.9025e-6 months (instead of 6 hours6.944444e-5 days 0.00167 hours 9.920635e-6 weeks 2.283e-6 months ).

3.

Rationale: Permits particle number of administered panicles to be main-5 5

tained in the range 2.6 x 10 to 4,7 x 10 per 4 or 5 mci dose of Tc.99m MAA. This is necessary because of the large fraction of our patients with underlying severe parenchymal pulmonary disease or pulmonary hypenen-sion.

C.

Tc.99m Sulfur Colloid (Mallinckrodt) 1.

Specific Nature.of Depanure: Pass 1 mL of Tc 99m Sulfur Colloid suspen-sion through a 0.45 pm filter.

2.

Description of Depanure:

a.

Prepare kit with 150 mci Tc 99m penechnetare, Filter 1 mL through 0.45 m filter.

b.

c.

- Use final filtrate for injection.

3.

Rationale: Filter allows retention oflarge colloidal panicles. Small panicles passing through filter are in the preferred size range for use in lym-phoscintigraphy.

D.

Inll! DTPA 1.

Specific Nature of the Depanure: Addition of 10% dextrose to the In ll!.

DTPA being used forinjection.

2.

Description of the Departure:

a.

- Draw volume required for 500 pCi In ll! DTPA dose into a syringe.

4-..

---nwye

-.m r,

.-r..

,.--_ner.-

i9

-.-c vm-m-n,

,ec.

,v--%.,,,,

v-r---r-t-ve*'-g s,-'

r--

a-*

u nuscxxorn : win:11:w R AniotoGY 5 November 1990 Page 4

{

b.

Dilute volume 1:1 with 10% Dextrose. USP.

l 3.

Rationale: Increases the flow rate of the radiopharmaceutical to the basal I

cisterns and decreases the " leakage" rate at the lumbar injection site during radionuclide cistemography.

E.

Pyrophosphate (PYP) 1.

Specific Nature of Depanure: Washing of Tc 99m modified in vivo labeled red blood cells with 0.9% Nacl, USP.

2.

Description of Depanure:

a.

Fifteen minutes after administering 1/2 to I vial PYP (vial reconsti-tuted with 2 mL 0.9% Nacl USP),3 5 ni whole blood is with.

drawn into a 6 mL syringe containing 0.51.0 mL ACD (acid citrate.

dextrose) solution.

L b.

The whole bloed is added to a sterile yellow top Vacutainer tube (no addidve).

Tc 99m penechnetate (30 mci adult; 0.25 mci /kg pediatric + 25%

c.

additional)is added to the blood and incubated at room temperature for 10 minutes.

d.

The whole blood is then centrifuged at full speed for 4 minutes, The plasma is removed and the Tc 99tn activity is measured.

e.

f.

The same volume of 0.9% Nacl, USP is added to the red cells remaining in the tube, g.

The tube is invened several times, and then recentrifuged for 4 minutes at full speed.

h.

The supernatant is withdrawn and the Tc 99m activity rneasured,in both supernatant and red cells.-

i.

If the supernatant contains > 10% of the total activity, the Tc 99m red cells are washed again (as in step f above).

J.

The same volume (as supematant removed) of 0.9% NaClis added to the labeled red cells before reinjectionc 3.

Rationale: The washing step, by removing unbound Tc 99m penechnetate-

- or free reduced Tc 99m, reduces the likelihood that either gastric or urinary.

activity will interfere with the interpretation of gastrointestinal bleeding

- studies.

e-<.w ee.r.--,

-e.w-w,..,-

m,,-wiw--,

4.-

e wwp

.ev.,.

-w.-.-

,,-S.

g v.

om,--

,-.e en n

-,yr-w-e.,.t v.cr-s-

v M \\1 LP CKRODI INYiltVE OF R A DIOLO(n t

5 November 1990 Page5 F.

Pyrophosphate (PYP) 1.

Specific Nature of Depanure: Washing Tc 99m modified In vivo labeled red blood cells with 0.9% Nacl, USP, and then damaging labeled cells by heating at 49.5' O.5' C for 20 minutes.

2.

Description of Depanure:

Fifteen minutes a fter administering 1/2 to I vial PYP (vial reconsti-a.

tuted with 2 m; 0.9% Nacl USP),3 5 mL whole blood is with.

drawn into a 6 mL syringe containing 0.51.0 mL ACD (acid-citrate.

dextrose) solution, b.

De whole blood is added to a sterile yellow top Vacutainer tube (no -

additive).

c.

Tc.99m penechnerate (3 6 mci)is added to the blood and incubated at room temperature for 10 minutes.

d.

De whole blood is then centrifuged at full speed for 4 minutes.

ne plasma is removed and the Tc 99m activity is measured.

e, f.

The same volume of 0.9% Nacl, USP is added to the red cells remaining in the tube.

g.

The tube is invened several times, and then recentrifuged for 4 -

minutes at full speed.

i h.

The supematant is withdrawn and the Tc 99m activity measured,in both supernatant and red cells.

i.

If the supernatant contains > 10% of the total activity, the Tc 99m

- red cells are washed again (as in step f above).

~

J.

The same volume (as supematant removed) of 0.9% Nacl is added -

to the red cells before reinjection.

k.

liest_the resuspended red cells in a water bath at 49.5' O.5' C for 20 minutes.

1.

Centrifuge sample at full speed for 4 minutes.

- Remove supernatant and measure activity in supernatant and red m.

cells. Add a volume of 0.9% Nacl, USP equal to supernatant removed.

Repeat the wash step (step m above)if supematant contains > 10%

n.

of the total activity.

i

.f

S ni 1 ' I I l' 4

'. i; ; s i i. I t il I i n i.( allit ). I t*'

4 rio. De i

t January 10 1991 1

Syncor inte rnat lonal Corp.

2208 West Central Ave, i

Toledo, Ohio 43606

Dear Syncor:

! have reviewed the package insert for 99m Te Human Serum Albumin and the procedure used in lymphat ic imaging with this agent.

I underst and that this procedure is a deviat ion f rom the approved uses.

Until further notice, please use 99m Te labeled HSA for lymphat ic imaging in malignant melances.

I wish to use the radiopharmaceut leal that provides the lowest patient-absorbed dose and most rapid diagnostle information.

I believe that using 99m Te labeled HSA represents a significant clinical benefit warranting the use of this procedure for our pat lent s.

Sincerely, p

j gw 4' G.'B. Mehta M.D.

Chairman Department of Radiology CBM/ sac

Att, l

l l

r l-

%*i

9I

$l.

+

s t

,g a.

4

--,,v

-..n-

.~,c

<--.,,s,.s

,.,a av..

.,u w,--

--.n

e llSilH-DRH 6 Feb 1991 llEHORANDUlf TOR THE HUCLEAR REGULATORY cotillISSION

SUBJECT:

Departure from the Hanufacturer's package insert for the preparation of radicpharmaceuticals.

i 1.

In response to the rederal

Register, Vol.

55 No.

164 Thursday. August 23, 1990, pages 34513-18, an interia rule titled

' Authorization to Pre!Are Radiopharmaceuticals Reagent Kits and Elute Radiopharmaceutical Generators Use of Radiopharmaceuticals for Therapy".

The interim rule allows licensees who elute generators and prepare reagent kits to depart from the manufacturer's instructions for elution and preparation in the package insert, provided the licensees meet certain conditions and i

limitations.

2.

The following departures from the package insert are used within the Nuclear Hedicine Service on either a daily basis or on a as needed basis for benefit of patient care and diagnostic

studies,

a. On a daily basis. Hethylene Diphosphonate (llD P ) cold kits, by any"'manu f ac tu re r a re compounded with an activity of 600 mci of Tc Pertechnetate as a cost savings measure to the clinic.

Hont kits on the market are limited (by the package insert) to 200 mC1.

Radiochemical purity is checked

daily, using paper chromatography to insure the tagged compound is within the USP and HRC guidelines, b.

On a daily basis, Ascorbic Acid (3 mg) is added to the HDP kits to prevent any oxidation of-the kit and resulting breakdown of the hit.

c.

For V/Q scans an patients with a Right to Left shunt, or in patients wit.h possible pulmonary hypertension.

the Hac roa gy"r e g a te d Albumin (HAA) kits are compounded with 100 mci of Tc Pertechnetate.

Double-the amount stated in the package insert.

in the etfort to limit the number of particles. injected during the study.

~d.

-On a weekly basis.

Xe-133 as a radiochemical is dissolved in saline and used for injection for burn lung and heart right ventricle 'first pass" studies, e.

As ' needed.

"'Tc Diethyelenetriamine pentaacetic acid (DTPA) is used for gastric emptying studies, f.

As

needed,

"'Tc-exametazine white blood cells are labeled for detection of infection.

(a%C' )

}

s

..,m.,

.r~,

,,,m.,_...,--.,,.,,,--_m._-,y m-

,m-,

e

.y-

3.

The above uses, while not included in the package insert. are reported in current medical journals of nuclear medicine and are f ound to be usef ul and appropriate f or medical care at this medical facility.

b.

~N

.3 jai K D. HEIRONIHUS II. H.D.

Dt. Col.. USAr. HC Chief. Nuclear Hedicine Service

i SynCor-ff OEMWARE 5 pett* *c;N.vg, o 3 "'

G 40 0Meca aq, p%; g. ! t C ARK.:CV.vnt 97.,*

T

?f

'3 r.J '?

g

Dear Syncor:

In accordanca with the August 23, 1990 Interim Final Rule issued-by the Nuclear Regulatory Commission concerning the compounding and of radiopharmaceuticals, I hereby direct-you to compound and-dispense Tc99m Sulfur Colloid, MDP, MAA, and other Tc-99 radiopharmace-use uticals in accordance'vith the Syncor prep guidelines.

I recogni:a that the manufacturers' package inserts for_ these prooucts specify a 6 hour6.944444e-5 days 0.00167 hours 9.920635e-6 weeks 2.283e-6 months time _of use, but my experience in their use has demonstrated be saf ely and ef f ectively used for -upl to 12 they may in fact that The 12 hour1.388889e-4 days 0.00333 hours 1.984127e-5 weeks 4.566e-6 months time of use is -needed to-that ths scheduling of hours.

the use of these products is neither inconvenient for this f acility or to-its patients.

This directive applies to all orders for - the - mentioned radiopharmaceuticals unless 'you are 'inf ormed otharvise, sincerely, s/ \\/

f$b g 4

W-ibimuiu mi n-i-

m-1

~

. _ ~

... ~_

A *:,

'!o: frir.K bddy, itanaq Ranager MeganAcDonouca,itarnacylepresentativt hCE;

,4).

/,Mi c> C L a J /// j) m...o r:

a,< u.a.

W e

it: tritten Directive for fluting Generators ed Preprinq Radiornaruceuticais

tar Megan ud har.t, as we discussed en December

.,1990, I request that Syncor Intenational Corporation prepre ad dispnse -

ladiopr,aruceuticals according to the attacted Kit Prepration Guidelines, dated November 1949. I have initialed '

a copy of the cuidelines attatched to indicate our review.

!te attacbed cuidelines satisfy the requirements of 10 CTI Part M 200 that I provide a written directive with

te natu. M precise description of deMrtures free the manufacturer's instructions in sluting generators and

.;tegriDqdiagnosticreagentkits.-

n ny Judgenut, these departures free manuf anurer's instructions are justifled for tae following reasons:

s Adjusting the ' ctivity used in recorctituting RAA is necessary for ptient safety. Failure to nate tais a

ozensation could result in acninistration of an improper naber of particles to the ptant, ;aing a slanificant r st to the p tient in the event of pulsonary escolus.

' tises of use for Sulfur Colloid, EP, and RAA are extended to twelve'bours to f acilitate ptient sctedulinq

uring tte dan anc to allow ovenight use of. doses for energency cases. flee or use for f:04 is extenced -

t: twenty four Dours for t5e sans reasan.

ilmes of de for Sulfur Colloid, EP, RA, and fc04 tave been estanded to allow for a practical delivery 3 scneoule fros_tbe pcanecy. Without the option of using the services of a radiopcanacy, tais depriment

.ould tv forced to elute generators and prepare radiopbarnaceuticals in-bouse. Because of.the videspread inertage of qualified fuelear Medicine fechnologists, tSe tlas diverted to these activities would result -

.n a reduction in the quality and questity 'of ptient care delivered in this depriment. Further, we Delieve -

ttat using a centralized radiopharna:y allows this institution ?-

'ake advantage of the esprience and ispenise of a licensed radiopharnacist vtica ve would not othervue nave.-

31s directive applies to all'orden placed by this institution for these radiophanaceuticals, unless you are trecifically-instructed ettervise at the tuo tte orcer is placed, or until taas directive is cancelled er

eplaced.-

sincerely yours.=m ny jh.ampN }'0

,/

I i-

---,m, e,...

g.

..,,a

-m,-

, ~

.~~,- n

-,.n.w,,

.,,v..

e

-n-e.,.,-.

,y

,,n..,.

a r e

Cm NSULTING RADIOLC IS.JCORR i

paoiotooints I. RAY, Ultn ASOUND AND NUCLE AR MEDICINE BUSINE$$ OFFICC -

s t riwsuv u o rhysiciens and Surgeoes Building 4351 u neo,Simt o

at uttas.u o 3100 W Central Avenue towe ob.o 4XO5 n w siotal u o To'edo, oNo 43606 (d'91473 3553 eu novtw uo f 419) 535 7158 u a Nott uo D I Hoovtn u o -

O $IU[$ u" F, "a?;"

S $ uANtoN u 0 october 16, 1990 Syncor Inc.

2208 W.

Central Ave.

Toledo, Oh.

43606 Dear Syncort In accordance with the August 23, 1990 Interim Final Rule issued by the Nuclear Regulatory Commission concerning the compounding and use of radiopharmaceuticals, I hereby direct you to compound and dispense Tc99m Sulfur colloid, MDP, MAA and other Tc-99 radiopharmaceuticals in accordance with the Syncor prep guidelines.

I recognize that the manufacturers' package inserts for these products specify a 6 hour6.944444e-5 days 0.00167 hours 9.920635e-6 weeks 2.283e-6 months time of use, but my experience in their use has demonstrated that they may in fact be safely and ef fectively used for up to 12 hours1.388889e-4 days 0.00333 hours 1.984127e-5 weeks 4.566e-6 months . The 12 hour1.388889e-4 days 0.00333 hours 1.984127e-5 weeks 4.566e-6 months time of use is needed so that the scheduling of the use of these products is neither inconvenient for this facility or to its patients.

This directive applies to all orders for the mentioned radiopharmaceuticals unless you are informed otherwise.

Sincerely,'

S. T. hinsky,H.D.

STP/nk

Written Directive for exceeding recommended package insert dosage:

MDP-In my judgement, these departures from manufacturers instructions are justified for the following_-reasont-Adjusting the activity used for Bone scans to 27-30 mC1, to allow for SPECT imaging with greater count rates, and decreased scannine time.

Also to increase scan quality and image resolution.

@M O

t-Authoilzed User Physician

'The patiente - health will not be af fected by this change.

January 1, 1991 l

. -.1 Written' Directive-for exceeding recommended package-insert dosages

201 71-In my judgement, these-departures from manufacture.rs in-structions are-justified f or the following~ reason

Adjusting the dosage for Thallium 201 Chloride to 3.5-3.8-mci-to decrease imaging time and. to increase image quality-and resolution, while performing-SPECT Thallium studies.

The patients health will not' be af fected by this : change.

)

W 0

2'LGr Authorized User Physician January 1, 1991

Written Directive for exceeding recommended packago. insert dosaget-4 I

DTPA-We will be using 99mTc DTPA Aerosol jn. place of 133Xe gas-for Ventilation lung imaging.

In my judgement, these departures from manufacturers instructions are justified for the following i reasons:

The availability of 99mTc DTPA and the reduction in cost, greatly exceeds that of-133Xe gas.

Aerosol studies are preferred over gaseous studies (in this institution) because all views of the lung may be obtained with aerosol imaging, which provides a better mechanism for comparison with the perfusion images.

No need for negative air flow in imaging rooms which requires monitoring twice yearly to comply with HRC specifications.

The patients health will not be affected by this change.

(34uudt0

?& -

Authorized User Physician January 1, 1991

m,

..._m Hendecks County Hospital 1000 East Main Street Y

P O. Boa 409

_ Danvitie. Indiana 46122 1314 745 4451 October 17,+1990

Dear Syncor:

In accordance with the August 23,1990 Interim Final Rule issued by'the-

~

Nuclear Regulatory Commission concerning the compounding'and use.of radiophannaceuticals. _1 hereby direct you to compound _ and _ dispense-Tc-99m sulfur Colloid, MDP, MAA.- and other Tc 99m radiopharmaceuticals in-accordance with Syncor Kit Prep Guidelines. -l recognize that the manufacturer's packages inserts for these products specify 6 hour6.944444e-5 days 0.00167 hours 9.920635e-6 weeks 2.283e-6 months time of use,' but my experience in their-use has demonstrated that-they may:in fact be-used safely.

and effectively for_up to 12l hours.- The twelve hour. time of use is-needed so that the schedulin9 of the use of products is neither inconvenient for this-facility or to its patients.

This directive applies to all orders for the _ mentioned radiophannaceuticals-unless you are informed otherwise.

Sincerely, ohn P. Calhoon, H l

,..*s i TO.

Syncor Pharmacy Manager FRCM Authorized User Physician PE Wrinen DirectNe for Eluting Generators and Preparing Raciopharmaceuticals As we discussed on i 1 b ttt hh tw. I request that Syncor international Corporation prepare and dispense Radiopharmaceuticals accoroing to the attached Kit Preparation Guidelines, dated November 1989. I have initialed the copy of Gudelines anached to indicate our review.

The attached guidelines satisfy the requirements of 10 CFR Part 35 200 that I provide a written directive with the nature and precise description of departures trCm manufacturer's instructions in eluting.

Generators and preparing diagnostic reagent kits.

In my judgement, these departures from manufacturer's instructions are justified for the following reasons:

o Adjusting the activity used in reconstituting MAA is necessary for patient safety. Failure to make this compensation could result in admin'stration of an improper number of particles to the patient, posing a significant risk to the patient in the event of pulmonary embolus.

o Times of use for Sulfur Colloid. MDP and MAA are ex1 ended to Melve hours to facilitate patient scheduling during the day, and to allow overnight use of doses for emergency cases, o

Times of use for Suffur Colloid MDP and MAA are ex1 ended to twelve hours, to allow for a practical delivery schedule from the pharmacy. Without the option of using the services of a radiopharmacy, this department would be forced to elute generators and prepare radiopharma.

ceuticals in house Because of the v.idespread shortage of Cualified Nuclear Medicine Technolo, gists. the time diverted tc these actiulies would resu'i in a reduction in the quality and quantity.

of patient care delivered by this department - Fur 1her we believe that using a Centrali2ed radiopharmacy a' lows thc. inst tute ta t$ e ad.an!a ;c c' the experience and expertise el a.

l. censed rad:0 pharmacist wh ch we ocu:d t.pt other'. 50 t's.c NOTE:

Follow Package Insert Requirements for DTPA-Renal Exp Time N s c.rective applies to all orders piated by this institution for these radiopharmaceuticals unless you a'e specifically instructed otherwise at the time the order is placed. or until this directive is cancelled or replaced.

Sincerely yours.

fi s wn/W1

m. am,. m..

,.. ;. c. n....... ] O ' M

lle,t.a f

to.t w, m y v. a p u..

2 51 '5 q

s

=

m e

4

.j

'is_s F oyd

~

Vemorial ospito

==

Ja:n:ary 11, 1991 Mike W ant, Fhanracy Manager

/

Syncor International Phanracy Service Center 831 South 6th Street laatsville, KY 40203 L

Dear Syncor:

In accordance with the August 23, 1990 Interim Final Rule-issued by the-Naclear Regulatory Cocmission' concerning the-compounding and use of-radiopharraceuticals, I' hereby direct you to com3ound and dispense Tc99m Sulfur Colloid, MDP, PAA, and other Tc-99 radiopunraceuticals in<

accordance with the Syncor prep guidelines.

I recognize that the-ranufacturer's package inseres for these products specify a 6. hour thne of.

use, but my experience in their use has dearnstrated that they may_ in fact be safely and effectively used for up to 12 hours1.388889e-4 days 0.00333 hours 1.984127e-5 weeks 4.566e-6 months . 'Ihe 12 hour1.388889e-4 days 0.00333 hours 1.984127e-5 weeks 4.566e-6 months time of use is needed so that the scheduling of.the use of these products is.neither.

-inconvenient for this facility or' to its patients.

'Ihis directive applies to all orders for the rentioned radiophanraceuticals unless you are informed otherwise.

Sincerely, h-f' m William R. - Fortner, M.D.

Fadiation Safety Officer.

WRF:1crb -

f f

l.

VHA.

w nummevwum l

90 cir C.Jw A W,.JSvM-}Aw 47iCO /QD&d 771

... ~,. - _..,, _,

+

PART 30 RULES OF GEtJERAL APPLICABILITY TO DOMESTIC LICEtJSitJG "

u e3633 General requirernents for luvance

- 39 c,f this chapter shall be subject to appropriate NRC Regional Otfae of speofk hunnes-all the provisions of the Act, now or specified in i 30 6 and to affected offene hereaf ter in e!!ect and-to all vahd tal An application for a specific 11 rules regulations and orders of the g,, response organinhone gthin sui certse will tw approved !!

months after the change is made Corntntssion-tis The appheauon is for a purpose

,, Frcpused danges that decrease, or authorized to the Act, Ibi No Heense lasued or granted pur cr potentially decrease. the effectneness of (2) Ttte appheant's proposed equip.

svant to the regulations in this part *5 the approsed emergency plan mey not -

and f acilities are adequate to and Parts 31 through 3E and 39 nor b ment be implemented without pnot protect health and minimize danger to any right under a licenze shall be e life or property; traitsferred, sulgned or in any manner appbcation to and prior apprt ul by the I (3) The applica,nt is quahfied by disposed of, either voluntarily or invol Comrnimon.

R tralning and expertence to use the ma.

untarily, directly or ; Indirectly terial for the purpose requested in through transfer of control of any 11-W bch ne W e, W d %,

such manner u to protect health and teruse to any person, unless the Com-w ntn.a '% ra.. s M heNd

_mmimize danger to hfe or property; mission shall, after securing full irdor-tra nrob ucu w h ;r; *Wm 925 mation, find that the transfer la in ac. E eer,erston ca!, test tnt ectNW r~

cordance with the provisions of the 0 Act and shall ghe its consent in writ' $ eiuates lot mohbarr.u%

k (4) The appheant satisfies any Spe-berrowh tr. actocar.ct s er g cial requirements contained in Parts ing.

, gg gg g y 32 through 35 and 39, and (c) Each person licensed by the Com 2 chatner Tne liternee s%"i record int a

mission pursuknt to the regulations in L-this part and Parts 31 through 35 and f** "I '"O W a d mn ed

- (5) In the case of an appheation for 39 shall confine his ponession and use record for t rve vem m me rewd n of the byproduct material to the loca.

ruae a license to recene and possess by-tions and purposes authorized in the 2 product material for the conduct of any activity which the Comminston de*

license Except as otherwise provided (h)<ll Each ilcensee shall notify the termines will signif.cantly af fect the in the license, a license lasued pursu-appropriate NHC Reglor.al Admints-quality of the environment the Diree-ant to the regulations in thls part and trator, in writing, immediately follow, Parts 31 through 35 and 39 of this ing the filing of a voluntary or invol-of Nuclear Materla! Safety and e chapter shall carry with it the right to tot of his designee, before untary t.etition for bankruptcy under Sateguat d*

rece!ve, acquire, own. and possess by.

any Chapset of Title 11 (Bankruptcy) commencement of construction of the product material. Preparation for of the Urtted States Code by or pRnt or f acthly in shich the activity shipment and transport of byproduct against; will be conducted on the buts of in-matertal shall be in accordance with ?

(1) The licensee; formation filed and evaluatiens made the provisions of Part 'll of this chap ': ttu An entity (e4 that term ts defined pursuant to Subpart A of Part 51 of ter.

a in 11 U.S.C.10ltl4D controlling the 11-this chapter, hu concluded, after (d) Each license issued pursuant to

censee or listing the beense or licensee setshing the erntronmental econom-the regulations in this part and Parts 7 as property of the estate, or te, technical, and other benefits 31 through 35 and 39 shall be deemed (111) An affiliate (as that term ta de-against environmental costa and con-to contain the provisions set forth In fined in 11 U S C.101(2D of the licens.

S sidering avat able alternatives, that section 183b.-d., inclusive, of the Act, et,

? the action caHed for is the issuance of whether or not these provisions are (2) This notification must indicate:

a the proposed license. with any appro-expressly set forth in the license.

(1) The bankruptcy ccwi in which

priate conditions to protect environ-(et The Commission may incorpo-the pe tition for bankruptcy was filed;

mental values. Commencement of con.

rate. in any license issued pursuant to and struction prior to such conclusion the regulations in thla part and Parts (11) The date of the fihng of the pett-shall be grounds for denial of a license 31 through 35 and 39, at the time of ts'

tion, to recche and posacss byproduct mate.

suance, or thereafter by appropriate rtal m such plant or f acility. As used in rule, regulation or order, such addi this paragraph the term " commence.

t!cnal requirements knd conditions Mll) From Aest 23, Vr.81 to Amst ment of construction" means any with respect to the licensee s receipt, gygg g

and process ~ radmcthe m*derial clearing of land. excavation, or other possession. use and transfer of byprod.

substantial action that sould adserse-uct material as it deems appropriate or w th dane 2c reugentlutt far which A! Drug Ad.ninisunnon ly affect the environment of a site.

nscessary in order to:

I m'

to ce ay e fo sit p

(1) Promote the common defense Afh D

u> d p r mm tion. borings to determine foundation and security; tb rnandaMer's elukon and conditions. or other preconstruction (2) Protect health or to minimize p rparution instrur t;orm {for mon!toring or testing to establish e danger to life or proMrty; radaphamaccuhMs authuhd for oc background Information related to the g (3) Protect restricted data; O pasunt to i 35 200) provided th..t; suitability of the site or the protection.

(4) Require such reports and the 0 M 1he kensee has a wouen dinune of environmental values.

g keeping of such records, and to pro' 2 trade by an authonrrd w.cr pl pinan g gide for such inspections of activttles

dut dmcts a specMe depariore for a (b) Upon a determination that an under the license as may be necessary $ pencular pahent,er peSents, or for n or appropriate to effectuate the pur-application meets the requirements of poses of the Act and regulations there-mdehurmaceutul, and which

- the Act, and the terJlations of the under~

Comm the Comrnission will depctare. a preeme dext @n uf the.

E assue a!uion, spectfte beense authortens the depetus and a braf stateaient of the R pouenton and use of byproduct mate.- em(f) Ucensees requued to subm.t ergene) plans by I 30 32(i) shall rwns why the departere frurn the nal < Porm NRC 314. " Byproduct Ma.$ follow the emergency plan approved by runuM.Ws imms la

_terial License t 3

the Commission The hcensee may PWann8 % dnphemmuc ol

" change the approved without

""mid ob's.n medical rewhs cut giat34 Term and condiuone of brennes' 3Q approval only if the mherwise at+nnable or would reduce 3 (as Each heense issued pursuant to cheges do not decrease the medicaltisks to peticular pat;ents z tne regulations in this part and the effei.iaeness of the plan The innwe bmuse of their medd cenahon, lie o regulations in Parts 31 through 35 and sh41 fumish the chinge to the I'censet shall keep the wrdien daecuw 30 9 August 31,1990 i

og 30.M il PART 30 e RULES OF GENERAL APPLICADILITY TO DOMESTIC LICENSING" r

erd abrd (J the number of receipt of bcensed matenal 'As part of (f) Fmancial assurance for the cerhhcahon a com of the hnancial-decommissioning must be provided.by pesmpions depenu d undtr tf 4e instrument obtamed to satafy the one or more of the following methods:

- di pattore m an uuditable form and requirements of paragraph lf) of this O) Prepayment. Prepayment is the m aibible for m>peu.un for 5 yeato or section is t be submitted to NRC.

deposit prior in the start of operation M) An authorized uwr phys tan

{c)11) Each holder of a specific license into an account segregated from hcensee issued on or after July 27,1990. w hich is assets and outside the licensee's ita ni atmg the of a type descnbed m paragraph (a) or admirustratise control of cash or liquid n..hopharm.a cunal m order to make a (b) of this section. shall provide assets such that the amount of funds e ntten d4rettve woijd jeopardve the hnancial assurance for decommissioning would be sufficient to pay ptient's bedih because of the t mirgent in accordance with the criteria set forth decomrnissioning costs. Prepayment r.atune of the patwr.i's rnedical in this sectwn may be in the form of a trust. escrow tondmon in thin ciise. the brouce 61.41)

(2) Each holder of a specific hcense account, gas ernment fund. certificate of m oblem the wunen daruus e rnade by the inued before July 27.1990. and of a type deposit. or deposit of gosernment E, vothoraed act I ysJcian which descnbed m paragraph (a) of this secunties k

g antains the nutati n regarthng the section shall submit. on or before July (2) A surety method. insurance or t mcycacy and all t.e informat j 27,1990, a decommissionir g fund ng other guarantee method = These methods n

m

$ spn,fied m purugu.ph (q(1);i) o plan or a certificati,n of imancial guarantee that decommissioning costs u

a sechon w utan a m orking ( a) a ier t t,

anurance for decommissionmg in an wdl be paid should the licensee default.

prestnbed deprture sht: 1.ctro s all amount at least equal to $750.000 in be in the form of a A surety method maf' credit or line of keep these records in un coditubh form accordatae with the critena set forth in surety bond. letter o asd asuilhble Inr mspection Int 5 p uis-this section If the beensee submits the credit. A parent company guarantee of (2)The actions authorized in cernfication of fmancial assurance funds for decommissioning costs based parop aph 0)(1) of this section ute rather than a decommissioning fund.mg on a fmancial test may be used if the permatica notwnbstandmg rnore plan at this ume, the beensee shall guarantee and test are as contained in rentietn e tangengein bren* condmo"6 mclude a decommissioning fundmg plan Appendix A to this part. A parent un! cts those license crmdmors in any applicahon for hcense renewal' any guarantee meY not be used in specrfically reference 130 34til (31 Each holder of a specific license com[2ination with other financial cm p) Notbing in this section trht ves tlw issued before July 27,1990. and of a type methods to satis y the requirements of 1.censee from complying with other described in paragraph (b) of this oppia nble NRC. W A. und other Federal

,ection shall submit. on or before July

,"us d o pro kd f na c 1 y

or State regulations governing the 2' Itm a certification of fmancial assurance for decommissioning must o

dotion rif generators and prepurution of assurance for decommissioning or a 2 contain the following conditions:

_ rengent kits-decommnsionmg fundmg plan m 7.

(i) The surety method or insurance

. - g 30,35 Onancial assurance and accordance with the cntena set forth m must be open-ended or.lf wntten for a 2

recordheepmg for decommissionin9

_ this sectiort i specified term such as five year.. must (d) Table of required amounts of be renewed automatically unless 90

->fmanctal assurance for decommissioning days or more prior to the renewal date,

> !a) Each applicant for a specific laense authorizmg the possession and use of unsealed byproduct material of b) quantity of matenal.

the issuer notifies the Commission. the half.hfe prater than 120 da>s and in greater ihan to

but less than or beneficiary, and the licensee of its quantmes cueedmg 10 5 times the equal to to

nmes the appbca.

intention not to renew. The surety ble quanubes of appendix C to method or insurance must also provide

$.apphcable quantihes set forth in4ppenda C to il 20140M1 of 10

{ { 201 20 601 of 10 CFR part 20 that the full face amount be paid to the 9

shall in unwaled form !For a beneficiary automaticall) prior to the 2 CFR p.nl 20 submit a decommimonmg fundmg plan combinanon of isotopes if R. as expiration without proof of forfeiture if

$ as destnbed m paragraph (e) of this defmed m 4 30 3Nal. d:vided bY the hcensee fails to provide a sectmn The decommisuonmg fundmg g

toi n peater than 1 but R d" replacement acceptable to the plan tnast aho be submitted when a g

uded by to

is less than or Commission withm 30 days after receipt combmahon of isotopes is invoked if R y e@at to 1 L swo of notification of cancellation.

daided by 10 5 is greater than 1 (unity

- greater than to' but less than or (ii) The surety method or insurance rulel. where R is defmed here as the sum $

equal to 10

nmes the apphea.

mm be pyable to a trust established of the ratms of the quantity of each ble quannhes of append s C t for decommissioning costs. The trustee notope to the apphcable value m 1141-20 601 of 10 CFR part 20 and trust must be acceptable to the m

ra appendix C toll 20.1-20 601 of 10

]

Commission. An acceptable trustee includes an appropriate State or Federal

_ CFR part 20.

defined in 130.3 Mal, divided by

- Ibl Each upphcant for a specific to 8 is greater than 1 but R de government agency or an entity which Lcense authonzmg possession and use vided by 10

is less than or has the authority to act as a trustee and of M pmduct material of half.hfe greater e4tial to 1 ).

$150mo whose trust operations ark regulated thark 120 days and in quantities specified peMer than to times the apph.

and examined by a Federal or State in paragraph Idl of tb section shall cable gununes of appendix C to agency.

e n her-11201-20 001 of 10 CFR part 20 (iiil The surety method or insurance 5

(1) Submit a decorr missioning funding m scaled sources or" must remain in effect unbl the Commission has terminated the license.:

9 plan as descnbed in ragraph (e) of plaied fails Iror a combinanon E thts sechanc or of isotopes if R. as defined in (3) An external sinking fund in which (21 Submit a certification that i 30 35(el. dnided by to 18 is deposits are made at least annually.

2 Imancial assurance for decommissioning greater than 11..

$75.000 coupled with a surety method or insurance, the value ofwhich may has been provided in the amount

- (e) Each decommissioning funding decrease by the amount being prescribed by paragraph (d)of this p!an must contain a cost estimate for accumulated in the sinking fund. An section using one of the methods

.> decommissionmg and a description of ntmal sinkin fund is a fund desenbed in paragraph (f) of this y the method of assuring funds for established an maintained by setting section. For an appbcant. this a decommissioning from paragraph (f) of aside funds periodically in an account certification may state that the f this section. includmg means of segregated from licensee assets and appropnate aesurante will be obtained 2 adjusting cost estimates and associated outside the licensee e administrative af ter the application has been approved levels periodically over the life c ntrolln which thi atal amount of fundinfacility.

and the hcense inued but prior to the of the funds would be sufhcient to pay 3410 May 31,1991

3 M itd>

32.7 3t a i PART 32 e SPECIFIC DOMESTIC LICENSES TO MANUFACTURE OR TRANSFER...

m tuns the mformation caMed for ei the bcense issued t3 FD A. or a "Notse of pursuant to i 3514 of this chapter for Ifalkmr8g statement, arrears on a label Catmed investigational Lxemption for a the uws hsted m Group ill of SsheJule

{ af fned to enh prepadaged unit or New Drug" tlND) acterted by FDA; or A,

[ 35 100 of this chapter will be a appean in a ie40ct or brochure which (u) The manufacture and distribution approved if tSee Note 1)

N accornparues the par kage. '

of the radiopharmaceutwa! contammg (1) The apphcant satafies the general

by product material is not subject to the requirements specified in [ 30 33 of this Tras rad +0artne materd may be retened.7 Federal Food, Drug, and Costnette Act chapter; acquired poucwed. and used ont) tn phys'$ and the Pubhc licalth Semce Act, (2) The appbcant submits endence cians. setermarians m the prattare of veterig nary medicine ehnRM laboratories or hospp,

(3) The apphcant submits inforrnation that.

. tats and only for m utro cimical or labora

on the radionuchde, chemical and ph)si.

H) The generator or reagent hit is to

tory test.s not huolung internal or etternal cal form, packaging including maximum be manufactured, labeled. and packaged

adrninistrat:on of the materiat or the radi

[ ation therefrom. to human twings or ani ac tivity per p ac k a ge, and shieldm3 in accordann with the Federal Food, mals tt.s receipt. amumtion riouemon. use.

provided by the packaging of the by.

Drug, and Cosmetic Act or the Pubt.c product material that is appropriate for llealth Servise Act, such as a new drug a

a a neen e f eU i

Recutatory commimon or or a State with safe handlmg and storage of radiopharma.

apphcation (NDA) approsed by the Food stuch the commwon has entered mte an ceuticah by group bcensees; and and Drug Administration (FDA), a bio-erment for the enerrue of resulatory av [

laic product hcense inued by FDA, or a 14HilThe label affixed to each package

" Notice of Claimed Insestigational Le mame ut M anuf acturer s of the radiophannaceubcal contains emption for a New Drug"(IND) accepted information on the radmnuchde.

by FDA;or quantity and date of assay, and the te) The label affned to the urut, or label, or the leaflet or brochure that (n) The manufacture and distribution the leanet or brothure which accompa.

accompanies each package. contains a

' I#""*'*'

*8'"I

' " I subject to the Federal Food Drug, and

$ rues the pack age, contains adequate mfor y statement that the U S. Nuclearbe hgulatory Commission has approsed Cosme tic Act and the PuMic flealth mation as to the prem tions to 4 otvned in handhng and storing such, distnbutwn of the radiopharmaceutical Serme Act.

, tg produe t matenal in the caw of the to persons hcensed to use byproduct (3) The apphcant submits tnformation a

- raatenal hated in il 35100 35 2tn or y Mxk lodme-125 reference er cabbration " 35 3an, an appropnate. and to persons on the radmnuchde, chemical and physi.

cal form, packagirig tricludmg maximum scurce, the mfonnatwn accompanyms w ho hold an equiv alent hcense issued actmty per package, and shieldmg the uurce must ako contain directwns to by an Agreement State. Ilowever. labels the beensee reg.irding the w aste ddposal worded m accordance with

$,aprov ded by the packaging of the by.

requirements set out in [ 20.301 of Part requirements that were m place on Q NM

""d

"** b

20 of this shapter.

Af arch 30.198' may be used until hf arch w generator or reagent kit;

,30.19a9 g (4) The latet affned to the generator or reagent kit contatns information on

~ bi) The labels, leafl*ts or trochures the radionuchde. quantity. and date of f3212 uanuf acture and castrstmon of required by this paragraph are in r lditmn auay;and resopharmaceuticals contaieg tiyproduct to the labehng required by the Food and (5 ) The label affned to the generator a matertaf for enescal ume unoc Part 35.

Dnig Administration (FD A) and they er reagent kit, or the leaflet or brochure j la) An appbcation for a specific may be separate from or, wuh the w hich accompa rties the generator or i ad o arrIareut$c appr val of FDA, may be combmed with reagent kit. contams:

crar

- byproduct matenal for use by persons the labelms required by FDA.

(i) Adequate tnforma twn, from a

" authonaed pursuant to Part 35 of this W H an appbcation is filed pursuant radiatmn safety standponit, on the proce-chapter w dt be approsed tf.

to paragraph (a) of this section on or dures to be followed and the equipment before October 15, 1974, for a license to and shielding to be used in eluting the rnanufacture and distribute a radio-generator or processing r3J1oactive ma.

p h armaceutical that was distnbuted tenal with the reagent Lit, and (1) The appheant satisfies the general c mmercially on r tvfore August 16, [ [i) A statement that this generator or requirements specified in [ 30 33 of thts 21974, the apphcant may continue the reagent kit (as appropriate)is approved thapter; E dtstribution of such radiopharmaceutical for distnbution ta persons hcensed by d)The appbcant semits evidence gt group heensees until the Commission the U S Nuclear Regulator > Commission "3 that.

iuues the beense er notifies the appheant to use byproduct materialidentified in cthe rwise ~

ll l 35200 or under an equivalent license (i) The radiophannaceutical contain-E ing byproduct matenal will be manufac.

@ 32.73 Manufacture and distribution of a of an Agreement State. Howeser. labels worded in accordance with

tured, labeled, and packaged in accord.

generators or reagent kits for prepara-l requirements that were in place on I ance with the I ederal Food. Drug and tion of radiopharmaceuticals containq htarch 30,1987 may be us(d until htarch Cosmetic Act or the Pubbe llealth Service ing byproduct material.

30,1930.

Act, such as a new dru g appbeation (a) An appheation for a specific a

e h e (NDA) approved by the Food and Drug hcense to manufacture ard distribute tton to the lebehnt twudc4 b) FDA Admirustration (FDA), a bmlogie product generators or reagent kits containing and they e-a) be septrste ficrn or,

'tabets authorued by the rerutations in bp d mateM for prephon d W W @mW M QA may N effect on september 26. 1919 may be used radiopharmaceuticals by persons lisensed c n Wd m W !aWig re pared until one year trom September 2L 1979.

DY C A-32 13 November 30,1988

9 32.10 h a l 3233(b)

PART 32 e SPECIFIC DOMEST1C LICENSES TO MANUFACTURE OR TRANSFER...

(vd) Legend and methods for labeling tvu) Masimum pressure w it hstood (b) If an appikation is fded pursuant sources nd desices as to their radioactive dunna protc4pe tests; to paragraph (a) of this section on or content; (viti) Manirnum quantity of contained t< fore Odober 15,1974, for a bcense to (vdO Instructions for handhns and radioactive matenal; manuf acture and distribute a generator oteistoring the source or device from the (ix) Radiotoxicity of contained radio-reagent bt that was distnbuted comJ radiation safety standpoint;these instruc-active matenal; mercally on or lefore August 16, 1974, tjons are to be included on a durable label (a) Operating eapenence with identi-the arphcant may continue the distribu w attached to the source or device or O' cal sources or c'evices or similitriy tion of such gerierator or reagent kit untilft attached to a permanent storage con,j designed and constructed sources or de-the Commission issues the license of tainer for the source or device; ProWded. e vices.

O notifies the applicant otherwise.

That instructions which are too lengthy g (pa)ragraph (a) of this section on or c If an appucation is filed pursuant NO11 l, Although the communion does for such label may be summari2ed on the to

{ not regulate the manufaciure and detritiution label and printed in detad on a brochure before October 15,1974, for a bcense to

,w of reagent hits that do not contain tsproduct or such hich is referenced on the label; manufacture and distribute a source or w

p fneterial, 61 dues reguiste the use essgens hits rof the preperstwn of radiopharma

=

ceut uis containins t> product mat' rial as part (3) The label affixed to the source or on or before August 16,1974, the ap-of its twemins and re,w.%i or the vers of device, or to the permanent storage phcant may continue the distribution of twevdut metenal. An> m anuf ac turer of container for the source or device, such source or device to group licensees reagent hits that do not contam hproduct contains information on the untd the Commission mues the license or material who desires to have his reagent kit 6 radJonuchde quandty and date of notifies the applicant otherwise.

s

.ppetaed H the Comsnmion ror use to persons asaay, and a statement that the U.S.

=

tuenied puriant to i 3s 4 and croup lit or Nuclear Regulatory Commission has

$ 32.101 Schedule B-Prototype tests

~

k he dste A,

13s 100 of this chaptet may N approved distribution of the (name of for lum! nous safety devices for use in satimit the g ettinent sorormation specirie-J in g g

g a era t.

NI Iuse byproduct material identified in

[ { { 35 2. 35 400. or 35MO. as An appbcant for a heense pursuant to j3234 nsanutecture and distrtbut on of appropriate. and to persons who hold an

( 32 53 shall conduct prototype tests on sources or devkee containing typroduct equivalent hcense issued by an each of five protorype luminous safety

"#"*'"*d**'""*'

Agreement State, llowever. labels devices for use in aircraft as follows:

l (a) An apphcation for a specific worded in accordance with (a) Temperature-e!ritude test. The de-g hcense to manufacture and distribute requirements that were in place on vice shall be placed in a test chamber as it sources and devices containing March 30, tW may be used untd March would be used in service. A temperature-

! byproduct matenal to persona licensed g g' altitude condition schedule shall be g pursuant to part 35 of this chapter for followed as outhned in the following use as a cabbration or trierence source or for the uses hated in il 35 400 and (b) (1) In the event the applicant steps:

35 No of this chapter mil be spproved desires that the source or device be Ster 1. The internal tempeiature of required to be tested for leakage of the test chamber shall be reduced to radioactiv e matenal at intervals longer

-62* C. (-80* F.) and the device shall be (1).The applicant satisfies the general than six months, he shall include in his maintained for at Icast I hour at this requirements in 5 30.33 of this chapter; appbcation sufficient information toe temperature at atmosphenc pressure.

(2) The apphcant submits sufficient demonstrate that such longer interval is 3 Step 2. The internal temperature of 1"I '** tion regarding each type of source justified by performance characteristicsa the test chamber shall be -raised to or device pertinent to an evaluation of its 54' C. (-65' F.) and maintained until of the source or device or similar sourcesh the temperature of the device ha radiation safety including or devices and by design features that (i) The byproduct rnateri.d conta$ed' laed at f 54' C. at atmosphene pressure.

its chemical and physical form, and have a signficiant bearing on the prob.

abihty or consequences of !cakage of Step 3. The atmospheric pressure of 4-h the chamber shall be reduced to 8)

(ii) Details of design and construction.'r6dioactive matenal from the source.

(2)in determining the acceptable milhmeters of mercury absolute pressure 3 of the source or device;

[ interval for test of leakage of radioactive w hile the.- chamber temperature is y,

(tti) Procedures for, and results of, g material, the Commission wdl consider maintained at -$4' C.

g prototype tests to demonstrate that the information that mcludes, but is not Step 4, ne internal temperature of g

hmited to:

the chamber shall be tatsed to r10* C.

source or device will maintam its mtegrity under stresses hkely to be encountered m

() Primary containment (source

(+14 F.) and maintained untd.the-normal use and accidents; capsule),

temperature of the device has stabihzed (iv) For devices containing byproduct (ii) Protection of primary cont ain.

at - 10'C and the internal pressure of 4

material, the radiation profite of a proto-the chamber shall then be adjusted to ment; U E' U

(iii) Method of scabng containment; atmosphene pressure, he test chamber (v) Details of quahty control p*oce-NC t on ' r.a.

door shall then be opened in order that dures to assure that production sources terials-frost will form on the device, and shall -

and devices meet the siandards of the g) Form of contained radioactive ma-remain' open untd the frost has tralted.

design and prototype tests; W-but not long enough to allow the mois-(vi) Procedures and standards for

(,;) Mn mum temperature withstood ture to evaporate. De door shall then be.

cahbrating sources and devices; during prototype tests; closed.

Howmber 30,1988 32 14

.~

UNITED STATES NUCLEAR REGULATORY COMMISSION RULES and REGULATIONS f

TITLE 10. CHAPTER 1. CODE OF FEDERAL REOULATIONS-ENEROY 35 i PART MEDICAL USE OF BYPRODUCT MATERIAL 35 Subpart A-GeneralInformation 35 205 Control of acresols and gases.

35 961 Trainmg for teletherapy p% sic:st 35 9?O Training for empenenced authonzed 35 220 Possession of sun ey instruments 351 Purpose and scope Subpart F-Radiopharmaceuticais for 35 9?1 Ph)sician trainirg in a three month 35 2 De firutions Therapy progra m 15.5 Maintenana cf ttcords 35 300 Use of radiopharmaceubcals for 35 r2 bcen d hnq 35 e inforrnahon collechon requirements O m appmsa) therapy Subpart K-Enforcement 35 310 Safety mitruchor'-

35 11 Lucr.se required 35 Wo Wolahons 35 315 Safety precauhans 35 12 Apphcahon for hcense. amendment.

35 320 Possendon of sune) mstruments 35 "

E" O " 'I ' "

8 or renewal requirements during transmen perad J513 1.ianse amendments Subpart 0-Sources for Drachytherapy 35 14 Neufaubons 35 400 Use of sources for brachytherap) h Au 3516 !*enseissuance 35 434 Release of pahents treated with 4 Secs 81.101.182. M M Sta \\

35 19 Specific esempt ons temIorarY imI ants Subpart B-Ceneral Administrative 35 G Drachytherapy sources ins entory 2201. 2232. 2233): sec 201. 88 Stat 1242 as Requirernents 35 410 Sefety instruction amended (42 U S C. 5641)-

54 bdIE ""U For the purposes of sec. 223. 68 Stat. 958. as 35 20 AIARA progrorp 35420 Numion of sung neumnt amended 142 U,5 C. 22?3): ll 3511. 3513.

35 21 bd atmn Safet) Officer 35 20 (a) and (b). 35 21 (s) and (b) 35 22. 35 23-35 22 Radiatum Safety Committee Subpart H-Ses'ed Sources for Diagnosla 35.25. 35-27la), (c) and (d). 35 31(a). 35 32ial. -

as 23 Statements of a Amy an 1 responsitMas 35 See Use o.f sealed sources for diagnosis 35 49. 35 50 f aHd). 35 51 f aHct 35 53 laHb),

35 59 (aHc) (e)(1). (s) ano (bl.35 60 35 61.

35;'5 Supen tsion 35 70 (aHO. 35 7s 35 60(aHet 3190.

35 2? Visitmg aWhorized user.

Subpart l-Teletherapy 35 92(a). 35120. 35 200 (b) and (cL 35 2N (a) 35 29 Admmistratne reqmrements that and ib). 35 205. 35 220. 35 3ao. 35 310ial

)$ wo Us f led rce in a apph to the prmision of mobde nuclear (c). 35 410la) 35 415. 35 420. 35 500 35 520.

medone senice

'elethe aI un '

d "E ' "

"8 n 11 bdiawn ulm p v & % i 35 205. 35 och,35 010 (a) and (bt 35 615.

n n Qa A man-ruro pwam p n :13 wnbm.a remru and rewrds 35 610 Safety instruchon el 35 620. 35 630 (4J and (b). 35 632 laHfL J5 634 r

of mmdmwam, 35 615 Safety precauhons

(aHe). 35 636 (4) and (b). 35 641 (4) and (bl 35 49 Sapphers 35 620 Ponession of survey instrument 8 35 643 (a) and (b), 35 645 fa) and (b). 35 900, 35 910. 35 920. 35 930. 35 932, 35 934.35 940.

35630 Dosimetry equipment Subpart C-General Technical 35 632 Full cabbrahon measurements 35 N1. 35 950. 35 960,35 961. 35 9 0 and Requirements 35 9?1 are issued under.ec. 1815. 64 Stat 948 35 634 Penodic spot checks' 35 50 Possession. use. cabbranon and check 35 636 Safety checks for teletherapy as amended (42 U.S C. 2001(b)) and il 3514.

of dose cabbrators facihties 35 21(bt 35 22(b). 35 23(bh 35 27 f a) and (c) 35.29(b). 35 32 (bHil. 35 33 f a Hbt 35 36(b1 35 51 Cahbrahon and check of suney 35 fA1 Radzation surveys for teletberapy ma truments facihties 35.50(et 35 5t[d). 35.53lci. 35 59 (d) and fe)(2),

35 59 (g) and (i). 3510 tat 35 80 fl 35 924 35 53 Measmement of radwpharmaceubcal 35 643 Modificat on of teletherapy unit or t

35 200(c), 35.2M{c). 35 300(b). 35 313(bt dosages room before beginning a treatment 35.315(b). 35 404(bL 35 406 (b) and idh 35 5? Authonrahon for cahbration and progra m 35 410(b). 35 415(b). 35 610(c]. 35 M 5;dh reference sources 35 M5 Reports of teletherap) surveys 35 630(c),35 632[gt 35m4;0. 35 636(cl 35 59 Requirements for possession of sealed checks. tests and measurements 35.64)(ct 35 M3(c). 35 645 and 35 641c) are sourcn and brachytherapy sources 35 M 7 Five-> ear inspechon-ssued under sec. toto. 6a Stat 950. as 35.60 Syrtnge siuelds and labels 35 61 % ial shields and hbels Subpart J-Treining and Esperience l araended (42 U.S C. 2201(o1).

35 70 Sun eys for contamina han and Requirements ambient radiation exposure rate.

35 900 Radiation Safety Officer.

Subpart A-GeneralInforrnation 35 75 Release of pahents containing 35 901 Training for expenenced Radiation radiopharmaceutics!s or permanent Safety Officer.

f 35.1 Purpose and scope.

implants 35 910 Training for uptake, ddution, and This part prescribes requirements and 35 80 Techmcal requirements that apply to excretion studies the proviston of mobde nuclear medicine 35 920 Traimng for imaging and locabaabon provisions for the medical use of.

byproduct material and for issuance of 35 9 age of volables and gases.

35 9 raining for therapeutic use of spectfic licenses authorizing the rnedical 3592 Decay.in-starage radiopharmaceuhcals.

t use of this material.These requirements 35 932 Trenning for treatment of

$ and provmons provide for the

.ubpart D-Uptalie. Dilution, and Excretton o

h> perthyroidism.

{ protection of the pubhc health and 35-.100 Use of radiopharmaceuticals for 33 934 Training for treatment of thyroid safety. The requirernents and provisions w

uptake. ddubon. and excretion studies.

carcinoma.

of this part are in addition to and not in 35 120 Possession of suruy instrument-35 940 Trairung for use of brachytherapy substitution for, others in this chapter.

Subpart E-Imaging and Localization 8 utt* * -

The requirements and provisions of 35 941 Trainirsg for ophthalmic use of 35 200 Use of radmpharmaceuticals, Parts 19. 20. 2L 30,7L and 170 of this strontium.90, generators and reagent kits for imagm8 35 950 Training for use of sealed sources for chapter apply to applicants and and locahzahon studies diagnosis.

licensees subject to this part unless 35 204 Permissible molybdenum 99 35 960 Trainmg for teletherapy, specifically exempted.

concentration.

35-1 July 31,1991 -

1

'y~

'D.2 PART 35 MEDICAL USE OF BYPRODUCT MATERIAL I302 Definitions.

' Managernent" means the chief (5) A brahytherapy radiation done.

~

" Address of use" means the buildmg esecuthe offker or that prtson's (t)lnvohing the wrong patient, wrong or basidings that arr identified on the.

deleFate or delegates radioisotope. or wrong treatment site hcense and where byproduct material "MedicalInsutu' ion" means an (excluding for permanent implants, may be received used. or stored orgarusatien m w hich several rnedical seeds that were implanted in the correct

" Agreement State" means any State (hsciphnes are practn ed site but migrated outside the treatment with which the Commission or the

" Medical use" rneans the intentional site);

Atornic Energy Commission has entered internal or e sternal administration of (iij involving a sealed source that is into an effective agreement under byproduct matenal, or the radiation leaking; subsection 2 4b of the Atomic Energy therefrom, to human bemgs in the (iii) When, for a temporary implant.

Act of 1954. as amended ptactice of medscme in accordsnce with one or more scaled sources are not "ALARA" (as low as reasonably 2 a hcense inst.ed b) a State or Terntory removed upon completion of the E procedure;or(iv) When the calculated adm of the United States the District of achles able) means making every

Columbia,or the Commonwealth of reasonable effort to maintain esposures M done differs from the prescribed dose by to radiation as far beinw the dose hrrots 2 Puerto Rico as is practical;

- "M2rustenal change" means a change $ rnore than 20 percent of the prevenbed that is made, after ascertaining the

$ dose.

(1) Consistent with the purpose for applicable requirements 4 by persons in (e) A diagnostic rndiopharmaceutical which the hcensed activity is authority m conformance with the dosage, other than quantities greater W

e M

We bMhmedende undert a k en, (21 Takmg mto ar. count the state of retmnar) judgment about whether iodide 1-125 or 1-13L both:

technology. the etunomics of those requirements should apply in the (t) Involving the wrong patient, wrong Improsements in relanon to benefits to caer at hand-radiopharmaceutical. wrong route of the public health and safety, and other administration, or when the societal and socioeconomic adndnistered dosage differs from the considerations. and

$> Afaodmmistratwn means the prescribed dosage; and (3)In relation to utthration of nuclear administration of:

(ii) % ben the dose to the patient energy in the public interest.

(1) A radwpharmaceutical dosage exceeds 5 rems effecthe dose

" Area of use" means a portion of an greater than 30 microcuries of either equivalent r 50 rems dose equivalent to address of use that has been set aside

odium iodide I-125 or 1-131 any individual organ.

for the purpose of receiving. using. or (i)Involvmg the wrong patient or storms byproduct matrnal wrong radiopharmaceuticah or

~ _"

""O*'*' E "'UC',

" Authonzed user" means a ph)sician.

(ii) When both the administered means the transportation and medical

~ dentist, or podiatnst who is identdied as dosage ddiers from the prescribed

I h P'"d"C' ** "*I'

? an authorired user on a Cornmission or dosage b) more than 20 percent of the

" Output" means the exposure rate.

4 Agreement Statelicense that authonzen prescribed dosage and the difference dose rate, or a quantity related in a -

the medical use of byproduct material between the administered dmage and known manner to these rates from a 1 "Drachytherapy source" means an prescribed dosage exceeds 30 teletherapy unit for a specified =ct of

' mdividual sealed source or a microcunes.

manufacturer assembled source train (2) A therapeutic radiopharmaceut! cal exposure conditions, l

that is riot designed to be disassembled dosage, other than sodium iodide I-125

" Physician" rneans a medical doctor or doctor of osteopathy licensed by a or1-131:

I by the user.

l

" Dedicated check source" means a (i) Involving the wrong patient. wrong State or Territory of the United States, M the Datr6ct of Columbia, or the l'

radicactne source that is used to assure radiopharmaceuncal or wrong route of

! Commonwealth of Puerto Rico to admitustrahon, or l

the constant operation of a radiatmn detection or measurement device oser (ii) When the administered dosage

prescnbe drugs in the practice of 3 differs frnm the picscnbed dosage by w medicine.

i' several months or y ears.

f

" Dental use" rneans the mienbonal M more than 20 percent of the presenbed

" Podiatric use" means the intentional esternal administration of the radinhon E dosage, external administration of the radiation.

from byproduct material to human (3) A gamma stereotactic radiosurgery from byproduct mais rial to human radiation dose:

beings m the practice of podiatry in beings in the prachte of denustry in accordance with a license issued by a accordance with a hcense issued by a (i) Involving the wrong patient or State or Terntoty of the Uruted States, wrong treatment site; or State or Terntory of the United States.

the Datrict of Columbia or the (h) When the calculated total the District of Columbia, or the Commonweahh of Puerto Rao.

administered dose differs from the total Comaonwealth of Puerto Rico.

" Dentist" means an individual prescnbed done by more than to percent

" Podiatrist" means an individual hcensed by a State or Territory of the of the total presenbed dose.

hcensed by a State or Terntory of the Uruted States. the District of Columbia.

(4) A teletherapy radtation dose:

United States. the District o' f Columbia, or the Commonwealth of Puerto Rico to (i)Insolvmg the wrong patient, wrong or the Commonwealth of Puerto Rico to mode of treatment, or wrong treatrnent practice podiatry, practice dentistry.

site; In) When the treatment consists of

> Diognosticchnica/ procedures three or fewer fractions and the manualmeans a collection of wntten calculated total admmistered dose procedures that describes each method differs from the total prescnbed dose by g land other instructions and precautions) more than 10 percent of the total a

,A by which the licensee performs

- prescribed done.

diagnostic clinical procedures; where (iii) When the calculated weekly l

w i

$ each diagnostic clinical procedure has administered dose is 30 percent greater been approved by the authorized user than the weekly prescribed dose: or and includes the radiopharmaceutical (iv) When the calculated total dosage, and route of administration.

administered dose ddiers from the total presenbed dose by more than 20 percent of the total prescribed dose.

I

_ July 31,1991 -

35 2.

M"I N

PART 35 MEDICAL USE OF BYPRODUCT MATERIAL

~

& Presmbeddosage means the quantity

" Sealed source" means any b> product of radiopharmaceutical activity as-material that is encased m a capsule I 3 0 k " *"""^ d "* * "

documented:

detegned to prevent leakage or escape of Fach record required by this pan must (1)in a written doctive: or the byproduct rnaterial.

be legible throughout the retenton (2) Either in the di. gnostic chnical "Teletherap) physicist" means the penod spec:fied b) rach Cormmssion procedures manual or m any -

t mdividual identified as the teletherapy regulatiert The recurd may be the appropnate record in accordante with g physicist on a Commission license.

onginal or a reproduced copy or a the directions of the authorized user for

" Visiting authortred user" means an tmcroform p-ovided that the copy or diagnostic protec'ures-

? authonted user who is not identified as microform is authenticated by 6

rrescribeddm means

an authorized user on the hcense of the authorized personnel and that the 5

(1) For gamma stereotactic Llicensee bemg visited.

i microform n capable of producmp a E radiosurgery, the total dos as E clear copy throuF out the required h

$ documented in the wntten directive;

retention penod. The record may also be (2) For teletherapy, the total dose and

. stored in electroruc media with the dose per fraction as documented in the

> Written directive means an order in 7 capabibty far producmP eF6ble.

l wntten directive: or wnting for a specific patient, dated and accurate. and complete records dunny (3) For brachytherapy. either the total signed by an authonzed user prior to the the required retention period Records source strength and ciposure time or the admimstration of a radiopharmaceutical such as lette s. drawings, specificauons, total dose. as documented in the written or radiation, except as specified in must include all pertment miomatmn directive, paragraph (6) of this definition, such as stamps. irutialt and stgnatures.

containing the following information-The licensee shall maintam adeguate -

(1) For any admirustration of safeguards agamst tampenng with and

~ " Radiation Safety Officer" means the quantities greater than 30 microcuries of loss of receras individual ideniified as the Radiation Safet> Officer on a Commission license.

$' *. dium iodide I-125 or 1-131: the 3-(2) For a therapeutic administration of "9 ""'* # '

0'E#' #

~

> Recordable etent means the a radiopharmaceutical other than sodium iodide 1-uS or 1-13L the (a)The Commission has submitted the information collection requirements (1) A radiopharmaceuticalor radiopharmaceutical, dosage, and route o

of administration.

contained in this part to the Ofhce of radiation without a wntten directive 9

4 Managernent and Budget (OMB) for where a wntten directwe is required:

A 31 For gamma stereotactic s approval as required by the Paperwork (2) A radiopharmaceuticalor E"9g'{Uf8l

'{u' p e n. nd total 1 Reduction Act of1980 (44 U.S C. 3501 et p s radiaton where a written directive is y dose'.

' seq ) OMB has approved the required without daily recording of each information collection requirements in admimstered radiopharmaceutical dose per f ct a tr atment t.

n'd this part under control number 3150.

dosage or radiation dose m the appropriate record.

0o30.

(3) A radiopharmaceutical dosage

[5] For high dose rate remote afterloadmS brach) therapy: the greater than 30 microcuries of etther hadim ope, treatment site and total sodium iodide 1-125 or 1-131 when both:

(b) The a;' proved informahon 9,

c llection requirements contained in this (i) The administered dosage differs W For all other brachytherapy:

from the prescribed dosage by more part appear m il 35.12. 35 13,35 14,

, than 10 percent of the presenbed (i) Prior to implantation: the E 35.2L 352 35.23,35.27,35.29,35.31.

9 dosage and radioisotope, number of sources, and A 35.32,35 33 35 50,35.51,35.53. 35.59.

(ii) The difference between the source strengths. and cc 35.60, 35.6L 35.70, 35.80, 35 92. 35.004.

5 E administered dosage and prescribed (ii) After implantation but prior to g. 35.205, 35 310. 35.315,35 404. 35 406;

$ dosage exceeds 15 microcurtes:

completion of the procedure: the 35 410, 35 415. 35.006. 35 610, 35 615.

radioisotope, treatment site, and total 35 630. 35 M2. 35,634. 35 636. 35 ML

- (4) A' therapeunc radiopharmaceutical s urce strength and esposure time (or, 35 643. 35 645, and 35 647.

dosage. Other than sodium iodide 1-125 or 1-13L when the admmistered dosage equivalently, the total dose).

dtfiers from the prescnbed dosage by

~

more than to percent of the presenbed dosage; (c) This part contains information (5) A teletherapy radiation dose when collection requirements in addition to -

the calculated weekly administered.

those approved under the contici dose in 15 percent greater than the number specified in paragraph (a) of this weekly prescnbed dosef or section These mformation collection

16) A brachytherapy radiation dose a requirements and the control numbers when the calculated administered dose 9 under which they are approved as differs from the prescribed dose by more 8 follows:

'than 10 percent of the prescribed dose.

f (1)In 13512. Form NRC-313 is g approved under control number 3th 0120.

I 35.11 Ucense required.

(a) A person shall not manufacture.

produce. acquire, receis e, possess. use.

i 35-3 July 3t 1991

4 PART 35 MEDICAL USE OF BYPRODUCT MATERIAL or transfer byproduct material for use identified in the application or on (c) The program must include notice to medaal use except in accordance with a the bcense.

specific bcrnse issued by the workers of the program's existence and Commasion or an Agreement State.or i 35M Houncenons, workers' responsibahl) to help keep dose equivalents A1. ARA, a resiew of as allond m paragraph (b) of this A licensee shall notify the summaries of the types and amounts of section Commission by letter within thirty days byproduct material used, occupational (b) An indmdual may receis e, when an authorized user. Radiation doses, changes in radiation safety -

possess use. or transfer by product Safety Officer, or Teletherapy hysicist procedures and safety measures, and p

matenalin accordance with the permanently dacontinues performance continuing education and training for all regulations m this chapter under the of duties under the license or has a personnel who work with or in the supenision of an authonied user as name change or when the hcensee's sicinity of byproduct material, The prouded in 135 25. unless prohibited by mailing address changes The licensee purpose of the review is to ensure that bcense condition.

shall rnait the report to the appropriate hcensees make a reasonable effort to

$ 3512 Application for Heense*

adC. 4s identified in i 30 6 of this chapter-maintain individual and collective amendment, or renewat.

occupational doses ALARA.

(a)If the apphcation is for medical use l 35.t8 Ucenseissuance, 93521 Radiation safety omcer.

sited in a medicalinstitution. only the The Commission shallissue a license institution's management may apply. lf for the medical use of bypioduct (a) A licensee shall appoint a the apphcation is for medical use not material for a term of five years if:

Radiation Safety Officer responsible for sited m a medicat institution. any person (a) The applicant has filed Form NRC-implementing the radiation safety may apply 313 " Application for Materials License" program. The licensee, through the (b) An applicmon for a hcense for in accordance with the instructions in Radiation Safety Officer, shall ensure medical use of byproduct material as i 35 12; that radiation safety activities are bemg performed in accordance with approved descnbed m il 35100 35 200. 35 3m (b) ne applicant has paid any procedures and regulatory requirements 35 400 and 35 500 of this part must be apphcable fee as provided in part 170 of made b) fding an original and one copy this chapter; in the daily operation of the hcensee's of Form NRC-313. "Apphtation for (c) The Commission finds the byproduct material program.

Matenals 1.icenseT for guidance in applicant equipped and committed to (b) The Radiation Safety Officer shall:

completing the form, refer to the observe the safety standards (1) Int estigate os erexposures.

instructions in the most current versions established by the Commission in this accidents. spills. losses, thefts.

g of the appropriate Regulabry Guides. A

~ Chapter for the protection of the public unauthonzed receipts. uses. transfers.

g request for a license amendment or p health and safety; and i; disposals, misadministrations, and other 4 renewal may be submitted as an original A (d) The applicant meets the

deviations from approved radiation 3

and one copy in letter format.

a requirements of part 30 of this chapter, safety practice and implement (c) An application for a license for i corrective actions as necessary:

medical use of byproduct material as 7 13519 specinc esemptions.

(2) Establish, collect in one binder or e

destnbed in i 35 600 of this part must be The Commusion may, upon file. and implement wrttten policy and made by fihng an oQnal and one copy application of anyinterested person or P'

d"'{f -

of Form NRC-313. For g udance in upon its own initiative. grant such d

completmg the form. refer 'o the exemptions from the regulations in this byproduct matenal-instructions in the most current version part as it determines are authorized by Di] Receiving and opening packages of of the appropriate Regulatory Guide. A law and will not endanger life or byproduct matenal.

request for a hcense amendment or property or the common defense and (iii) Storing byproduct material renewal may be submitted as an original security and are otherwise in the public livl Keeping an inventory record of and one copy in letter format.

interest. The Commission will review byproduct matenah (d) For copies of regulatory guides.

requests for exemptions from training IV) Usmg byproduct material safely:

apphcation forms. or to submit an and experience requirements with the b.i) Taking emergency action if apphcation or an amendment request, assistance ofits Advisory Comr ittee on control of byproduct materialis lost:

refer to 130 6 of this chapter.

the Medical Uses of Isotopes.

(vii) performing periodic radiation surveys;.

1 35,13 Ucense amendments.

Subpart D-General Admin 4trative (viii) performing checks'of survey -

A bcensee shall apply for and must Requirements receise a license amendment:

instruments and other safety equipment:

(a) Before it receives or uses i 35.20 ALARA program.

lixi Disposing of byproduct material:

byproduct matenal for a clinical (a) Each heensee shall develop and (x)Traimng personnel who work in or procedure permitted under this part but implement a wntten radiation protection frequent areas where byproduct materialis used or stored.

not pernutted by the beense issued program that includes provisions for pursuant to this'part; keepmg doses Al. ARA-bi) Keeping a copy of all records and (b) Before it permits anyone, except a (b) To satisfy the requirement of reports required by the Commission sisitmg authonzed user descnbed in paragraph (a)of this section:

regulations, a copy of these regulations.

i 35 v. to work as an authorized user (1) At a medicalinstitution.

a copy of each licensing request and :

Ucense and amendments. and the under the license; management, the Radiation Safety (c) Defore it changes Radiation Safety.

Officer, and all authorized users must written policy and procedures required by the regulations.

Officers or Teletherapy Physicists:

participate in the program as requested (d) Defare it orders byproduct matenal by the Radiation Safety Committee-(3) Brief management once each year in excess of the amount. or radionuclide (2) For licensees that are not medical on the byproduct material program;

-or form different than authorized on the institutions, management and all (4) Establish personnel exposure heense; and authorized users must participate in the investigationallevels that, when exceeded, willinitiate an investigation (e) Before it adds to or changes the program as requested by the Radiation by the Radiation Safet areas of use or address or addresses of Safety Officer.

cause of the exposure:y Officer of the July 31,1991 (reset) 35-4

PART 35 MEDICAL USE OF BYPRODUCT MATERIAL

15) Establish ptisonnel esposure Olhcer. or a Teletherapy Physicist _

(b) A bcensee that supertnes an mushgationalleuls that. When before submitting a license apphcation indmdualis responsible for the acts and.

euceded. will mmate a prompt or request for amendment or renewal:

omissions of the supenised indnidual.

ms estigation b) the Radiation Safety (3) Review on the basis of safety, and 5 35.27 V' ting authorlud uur.

Ofhter of the cause of the exposure and approve with the advice and consent of W

a curmderation o! acnons that might b, the Radiation Safety Officer and the la) A bcensee may permit an) usitme taken to reduce the probabihty of management representative. or a thorized user to use hcensed material recurrence; disapprove minor changes in radiation for medical use under the terms of the (til For medical use not at a medical safety procedures that are not licensee's license for sixty days each nstitutioniep;>rus e or daappros e mmor potentially important to safety and are g

changet m radiation safety procedures permitted under i 3131 of this Part; b visiting authorized user has that are not potentiall3 irnportant to (4) Review quarterly, with the g

g, g

9;9n g safety With the educe and consent o(

assistance Of the Radiation Safety g

.: management and,if the use management and Officer. a summary of the occupational occurs on behalf Of an institution, the n For medical use at a medical rad:ation dose records of all personnel on's Radiation Safety mstitutmn assist the Radiation Safety 3 g b pr cf ma e ah Committee m the performance of its Re (2) The licensee has a copy of a assistance of the Radiation Safety g bcense issued by the Commission or an Othcer. all incidents irn olving

$ Agreement State, or a permit Issued by a i 35 22 flad ation Safety Commmee, byproduct material with respect to a Commission or Agreement Shte broad Each med4 cal mstitution hcensee shall cause and subsequent actions taken; y bcensee that is authorized permit estabhsh a Radiation Safety Committee and medical use, that identif '

e visiting in os ersee the use of b) product (6) Review annually. with the

authonzed user by name t. an material assistatice of the Radiation Safety authorized user for medical use; and tal Each Committee must meet the Ofhcer the radiation safety program.

(3) Only those procedures for which followins admmistratne requirements:

1 35.23 Statements of authority and the visitmg authonzed user is p) Membership must consist of at responsibitttles' specifically authonzed by the hcense or least three mdmduals and must include (a) A bcensee shall provide the permit are performed by that mdwidual.

an authorized user ol each 1)pe Of use Radiation Safety Officer, and at a (b) A bcensee need not apply for a permitted by the hcense, the Radiation medicalinstitution the Radiation Safety

!icense amendment m order to permit a Safety Ofhcer, a representaine of the Cmnmittee, sufficient authority.

ggg g

gg a nursing senice. and a representaine of

organizational freedom, and materia: as descnbed in paragraph fa) of management whois neither an

management prerogative. to,

-.this section e-A authanzed user nor a Radiation Safety p) Identify radiation safety problems;

{ (c) A bcensee shall retain the records a Officer. Other rnembers may be included [ (2) Initiate. recommend, or provid*

. specified in this section for three years as the hcensee deems appropnate.

- correctne actions. and

~? after the visitmg authorized user's last (2) The Committee must meet at least quarterly-(3) Verify implementation of use of licensed material, but may correctne actions.

(3) To estabbsh a quorum and to w discard the records if the visiting conduct busmess. at least one half of the (b) A licensee shall estabbsh and (authorized user has been hsted Comrnittee's membership must be state in wating the authonbes, duties.

authonzed user on the hcensee's license, present. mcluding the Radiation Safety responsibilities. and radiation safety Ofhcer and the managemenfs activities of the Radiation Safety

{ { 35.29 Mministrative requirements that Officer. and at a medicalinstitution the

appy to me prowston et moba nuctor e

representaine H) The minutes of each Radiation Radiation Safety Committee, and retain 4 !""* * " **

Safety Committee meeting must include:

the current edition of these statements y (a) The Commission will bcense 01 The date of the meetmg-as a record until the Commission 7 mobile nuclear medicme service only in ht) Members present.

terminates the hcense.

accordance with Subparts D. E and li of Dit) Members absent:

this part and l 31.11 of this chapter.

53525 SupervistorL T.,

hv) Sammar) of dehberations an"

'a A licensee that Permits the receipt.

l d

i du hcensees shall obtain a letter signed bs.

Re ommended actions and tl e

('t b' n1 d d d

g the management i each client for whdh Y

numencal results of all ballots; and p services are rendered that authorizes bi) ALARA program reviews

'[o((d b i 3 use of byproduct material at the chent's

{ address nf use.The mobile nuclear desenbed m 135.20(c).

1 b) of th a part shall:

a (5) The Committee must promptly

- p) Instruct the supervised individual

medicine service hcensee shall retam provide each member with a copy of the ji>in the prmeiples of radiation safety the letter for three years aber the last meeting minutes, and retain one copy for the duration of the hcense.

appropriate to that individual's use of pr visi n of suvice.

(b) To osersee the use oflicensed byproduct material and in the licensee's material. the Committee must:

wntten quahty management program:

(c)If a mobile nuclear medicine p) Review recommendations an ways (2) Require the supervised individual servira 9tovides services that the client to maintain inchvidual and edectne g to follow the instructions of the is also authorized to provide, the thent

-is responsible for assuring that services doses ALARA' g supervising authorized user, follow the M are conducted in accordance with the written radiation safety and quality-(2) Review. on the basis of safety and management procedures established by g,,g 3,s n this chapter while the e

with regard to the traimng and empenence standards in Subpart i of this the licensee, and comply with the

" mot 4e.aclear medicine service is a" der th hent's d regulations of this chapter and the

(d) A nobile nucl7a e icine service

[e"ifv$d d rect) bro th ma ufactufe fb p c

er an rz user e at n y

~

(3) Periodically review the supervised or distributor to the chent s address of i individual's use of byproduct material use.

{ and the records kept to reflect this use.

35-5 July 31,1991

-~_-_.m

~ _ _,

M 3D PART 35 MEDICAL USE OF BYPRODUCT MATERIAL

) 35.31 Radiation safety program (1) That, prior to adtninistration a the review. In an auditable form for written directive 8 is prepared for:

three years.

chon0es, (a) A bcens-e me make minor (i) Any teletherapy radiation dose; (c) The licensee : hall evaluele and changes in radiation safety procedures lti) Any gamma stereotactic respond, within 30 days after discovery -

that are not potentially important to radiosurgery radiation dose; of the recordable esent, to each safety, i ce rnimaterial changes, that (iii) Any brachytherapy radiation recordable event by:

dose-(1) Assembling the relesant facts were descr bed in the apphcation for br*nse renewal.or amendment except (iv) Any administratmn of quandhes including the cause; for those changes n il 3513 and 35(m greater than 30 microcuries of either (2) Identifying what,if any. corrective sodium iodide I-125 or 1-131: or action is required to prevent recurrence:

of this part Examples of such mirusterial changes indude: editing of (v) Any therapeutic administration of and procedures for clarity or conformance a radiopharmaceutical, other than (3) Retaining a record,in an auditable sodium iodide 1-125 or 1-131:

form. for three years, of the relevant with local draftmg poucy or updating names teicphone numbers and (2) That, prior to each administration, facts and what corrective action,if any, was taken.

addtroses; adoption of model radiation the patient's identity is verified by more safety procedures published in NRC.

than one rnethod as the individual (d) The licensee shall retain:

Regulatery Guides, replacement of named in the written directive; (1) Each written directive; and equipment; reassignment of tasks among (3) That fmal plans of treatment and (2) A record of each administered employees: or assignment of service related calculations for brachytherapy, radiation dose or radiopharmaceutical contracts for ser ices such as personnel teletherapy, and gamma stereotactic dosage where a written directive is dnsimetry. radiation safety equipment radiosurgery are in accordance with the g required in paragraph (a){1) above, in an repair or cabbration. wam disposal, respective written directives, A auditable form, for three years after the date of administration.

and safety surveys A licensee is (4) That each administration is in responsible for assurmg that any change 3 accordance with the written directive;

$ rno(e) The licensee may make difications to the quahty made is in comphante with the g and management program to increase the (5) That any unin; ended deviation requirements of the regulations and the e

from :he written directivt is identified program o efficiency provided the hcense.

(b) A bcensee shall retain a record of and evaluated. and appropriate action is program's effectiyeness is not -

decreased. The hcensee shall furm,sh the each change untd the hcense has been taken modification to the appropriate NRC renewed or termmated.The record must (b) The licensee shall; Regional Office within 30 days after the g mclude the effectne date of the change.

(1) Develop procedures for and modification has been made.

a copy of the old and new radiation conduct a review of the quality (f)(1) Each apphcant for a new license,

" safety procedures, the reason for the management program includmg. since as apphcable, shall submit to the

" change a summary of radiation safety the last review, att evaluation of appropriate NRC Regional Office in -

- matters that were considered before (i) A representative sample of patient accordance with 10 CFR 30.8 a quality making the change, the ognature of the administrations, management program as part of the Radiation Safety Officer, and the (ii) All recordable events. and.

apphcanon for a license and implement ognatures of the affected authorized (iii) Au misadministrations users and of management or. in a to verify compliance with all aspects of-l# t(e$C' medicalInstitution. the Radiation Safety the quality management program; these

('

8 Committee's chairm.in and the reviews shall be epnducted at intervals appii b s ni

'he -

management representatne.

no greater than 12 months, appropriath NRC Regional Office in' -

(2) Evaluate each of these reytews t accordance with 10 CFR 30.6 by January determine the effectiseness of the 27, M2 a written certification that the quality management regram and,if quality management program has been 135.32 Ousury management program.

required, make modi ications to meet implemented along with a copy of the

>(a) Each applicant or licensee under the objectives of paragraph (a)of this program.

this part, as applicable. shal! estabhsh section; and (J) Retain records of each review, g and maintam a written quality includmg the evaluations and Imdmgs of management program to provide high ze. confidence that byproduct mater al or radiation from byproduct material will i It becem of the pahann condmort a deley m 8 be admmistered as directed by the

- r to prmde a wnnen emaion to en euenns authorized user. The quahty wnnen dientne wooid jeop edae ine p.tieni, h" * """'*l'" h a * * * * '$s " "

management program must include docun win be accer.'*ue prmded n"am'"e ont written pohcies and rocedures to meet rmsson is documented immediately m the patient a E

ihe following speufic objectives record.nd a rmsed wnnen directne se..sned by the authonted user within 4a hours of the oral reueton Also a written revismn io an estatmg wntten dirnhve may be made for any diagnoeuc or therapeutn prwedure provided that the revision is dated and e4sned by an authonsed user prtoe to the

- Jminuttelmn or the tediophermaceutical dosest e

the brachytherapy dose. the samme stereotect:c radicearsery dose, the teletherapy done, or the riest isletherse) tractional dose If. bnause of the emeraent esture or the patient's wnd,uon. e delay m order 1o provide a wntien direcine would jeoperdue the patient's health, en ural directwe will be auspieble provided that the mrormsuon contained in the oral dirntive is demented immediately m the pahent's record and a wnnen dirative is prepared withm 24 hours2.777778e-4 days 0.00667 hours 3.968254e-5 weeks 9.132e-6 months of -

the oral directive.

July 31,1991 35 6

. ~

- -~ _.-

MM PART 35 fAEDICAL USE OF BYPRODUCT fAATERIAL j 35.33 NotMcations, reports, and records (b) Each liceesee shall retein a record 7 354, suppn re of missemwstist one.

of each misadministration for fne years A kmn may ne f r medicai use (a) For a misadministration:

The record must contain the names of (t) The heensee shall notify by all individuals inveh ed (including the telephone the NRC Operations Center '

prescribing ph)sician, allied health (a) h product material manufactured no later than the nest calendar day after personnel, the patient, and the patient's

!abeled. packaged and distnbuted m accordance with a hcense usued 1

discovery of the misadministration.

referring ph)sician), the patient's social (2) The hcensee shall submit a written E security number or identtfication pursuant to the regulatwns m Part av report to the appropriate NRC Regional X number if one has been enigned, a brief and ll 3212,3213. or 3274 of this Office listed in 10 CFR 30 6 withm 15 6 description of the misadministration, chapter or the equn alent regulations of.

days after discovery of the

$ why it occurred. the effect on ine an Agreement State; misadministration.The written report patient. what improvements are needed (b) Reagent kits that have been must inclute the licensee's name; the to prevent recurrence, and the actions manufactured. labeled. packaged. and prescribmg physician's name a brief taken to prevent recurrence.

distnbuted in accordance with an dencnption of the event; why the event (c) Aside from the notification approval by the Commission pursuant to occurred. the effect on the patient; what requirement, nothing in this section i 32 73 or an Agrerment State under improvements are needed to prevent affects any rights or duties of licensees equivalent regulations for the recurrence; actions taken to prevent and ph)sicians in relation to each other, preparation of radiopharmaceuticals fur recurrente; w hether the licensee nonfied patients. or the patient's responsible medical use; and the patient. or the patient's responsible relatives or guardians.

(c) Teletherap) wurces manufactured relatne or guardian (this person will be and distnbuted m accordance with a subnquently referred to as "the patienr hcense nsued pursuant to Part 30 of this in this section). and if not. why not. and chapter or the equivalent regulations of if the patient was notified what an Agreement Siaie.

information w as provided to the patient.

The report must not include the patient's Subpart C-General Technical -

name or other information that could Requirements lead to identificatwn of the patient'

) 35 50 Possess 6on, use, cahbration, and (3) The hcensee shall notify the a check of dose estierators.

referring ph)sician and also notify the 5 (a) A medical use hcensee authorized 1

- patient of the misadrninistration no later

~',, hall hane in its possession a dose to administer radiopharmaceuticals A than 24 hours2.777778e-4 days 0.00667 hours 3.968254e-5 weeks 9.132e-6 months after its discovery, unless 3

the referring physician personally

cabbrator and use it to measure the m

$ mforms the hcensee either that he wdl amount of artmty admmistered to each inform the patient or that. based on Ed medical iudgment, telling the patient

(

bcensee shall; would be harmful The hcensee is not (1) Check each dose c4.brator for.

required to notify the patient without constanc) with a dedicatec' heck first consultmg the refemng physicten. If source at the beginning of each da) of the refernng physician or patient cannot use.To satnfy Ihe requirement of this be reached withm 24 hours2.777778e-4 days 0.00667 hours 3.968254e-5 weeks 9.132e-6 months , the brensee paragraph. the check must be done on a shall nehfy the patient as soon as frequently used settmg with a sealed possible thereafter.The hcensee may source oinot less than 10 microcunes of not delay any appropriate medical care radium 226 or 50 micrucunes of any for the patient, including any necessary other photon emittmg radionuchde:

remedial care as a result of the (2) Test each dose cabbrator for misadmmistration.because of any delay accuracy upon mstallatmn and at least in notification-annually thereafter by assaying at least (4)If the patient was notified, the two sealed sources contammg different beensee shall also furnish, within 15 radmnuchdes whose actnity the days after discovery of the manufacturer has determined within 5

~

misadministration, a written report to percent of its stated activity, whose 3

- the patient by sendmg either*

activit3 45 at least to microcunes for (i) A copy of the report that was radium 226 and $0 rmcrocunes for any submitted to the NRC; or other phoan emittmg radmnuchde. and (n) A brief description of both the at least one of which has a prmcipal -

es ent and the consequences as they may photon energ3 between 100 kev and 500 affect the patient. provided a statement is included that the report submitted to g') Test each dose cahbrator for g3 the NRC can be obtained from the imearitp upon installatmo and at least hcensee quarterly thereafter oser the range ofits use between the highest dosage that wdi be adrnimstered to a patient and to a m wmm.m.i i,tephon number et ih. Nac opennone cene., i. t wu est.csm microcunes; and (4) Test each dose cabbrator for geometry dependence upon mstallation user the range of volumes and volume 354 July 31,1991

~~-

K50M PART 35 MEDICAL USE OF BYPRODUCT MATERIAL configurations for which it wdl be used.

exposure rate by not more than 20 (b) Any byproduct materiallisted in The bcensee shall keep a record of this percent and shall conspicuously attach 16 35100 or 35 200 with a half hfe not test for the duration of the use of the a correction chart or graph to the longer than 100 days in individual instrument.

amounts not to exceed 15 milucuries:

dose cabbrator (cl A bcensee shall also perform (c) A bcensee shall check each survey (c) Any byproduct materiallisted in appropriate check 5 and tests required instrument for proper operation with the ll 35.100 or 35200 with a half.hfe longer dedicated check source each day of use' than 100 days in indwidual amounts not by this section follow mg adjustment or

, repair of the dose cahbrator, A licensee is not required to keep to exceed 200 microcuries each; and.

(d) A licensee shall mathematicany

_ records of these checks.

(d) Technetium 99m in individual

- correct dosage readirgs for any geometry or hnearit) error that exceeds

{

(d) A licensee shall retain a record of a mounts not to exceed 50 millicunes.

j3559 Reptements for possession of T.

10 percent if the dosa e is greater than C each survey instrument cabbration for seated sources and brachytherapy sources.

to microcuries and shall repair or s three pars The record must include:

(a) A bcensee in possession of any replace the dose calibrator if the h

scaled source or brachytherapy source accuracy or cons'ancy error exceeds to (1) A description of the cahbration shall follow the radiation safety and

_ ercent.

procedure; and handling instructions supplied by the p

(2)The date of the cabbration a manufacturer, and shall maintam the

[ (e) A bcensee shall retain a record of description of the source used and the instructions for the duration of source z

a cach check and test required by this

" the source' t;e use in a legible form consenient to users.

P '" '

E section for three years unless directed dd s ind - d (b) A bcensee m possession of a 2 otherwise The records required m mstmment being ca;Wrated. the sealed source shall:

A paragraphs (bH1) through [b){4) of this (1) Test the source for leakage before CON

" " C1 "

m "Lsection must melude:

g cabba cion data, and the signature of the its first use unless the licensee has a (1) For paragraph (bl(11. the model

indmdual who performed the certificate from the supplier indicatmg cabbration.

that the source was tested within six a_nd senal ~ umber of the dose cahbrator, m

the identity of the radionuclide

{ 1 35.53 Measurement of months before transfer to the licensee; contained in the check source the date

. radiopharmaceutical dossges.

and of the check, the actisity measured, and A bcensee shall:

(2) Test the source for leakage at the initials of the individual who (a) Measure the activity of each intervals not to exceed six months or at other intervals approved by the performed the check:

radiopharmaceutical dosage that

~

(2) For aragraph (b)(2). the model contains more than 10 microcuries of a

? Commission or an Agreement State and dnd seria numbeT of the dose cahbrator.

photon emittmg radionuchde before 4 described in the label or brochure that the model and serial number of each medical use:

3 accompanies the source.

source used and the identit of the (b) Measure the activity of each (c) To satisfy the leak test radionuchde contamed in t e source radiopharmaceutical dosage with a requirements of this section, the licensee and its activity. the date of the test, the desired activity of 10 microcuries or less must.

results of the test.and the signature of of a photon.emittmg radionuclide before (1) Take a wipe sample from the the Rgdiation Safety Officer, medical use to verify that the dosage scaled source or from the surfaces of the

.does not exceed 10 microcunes; device in which the sealed source is and se a nun eo e e brator.

mounted or stored on which radioactive the calculated activities, the measured (c) Retain a record of the contamination might be expected to

=

7 activities, the date of the test, and the

measurements required by this section accumulate or wash the source in a g signature of the Radiation Safety 7 for three years, To satisfy this small volume of detergent solution and Officer and

); requirement, the record must contain treat the entire volume as the sample; 2

(y F r paragraph (b1(41. the model t the:

(2) Take teletherapy and other device e

and serial number of the dose cabbrator, source test samples when the source is the configuration of the source (1) Generic name, trade name, or in the "off ' position; and measured. the activity measured for abbreviation of the (3) Measure the sample so that the each solume measured, the date of the radiopharmaceutical. its lot number, and leakage test can detect the presence of test. and the signature of the Radiation expiration dates and the radionuclide

0.005 microcuries of radioactive matenal Safety Officer.

(2) Patient's name, and identification on the sample, number if ne has been assigned:

(d) A licensee shall retain leakage test f 35.5t calibrc. tion and checia of survey (3) Prescribed dosage and activity of records for five years. The records must instruments. -

the dosage at the time of measurement, contain the model number, and serial -

(a) A licensee shall cabbrate the or a notation that the total activity is numberif assigned, of each source survey instrurnents used to show less than 10 microcuries; tested. the identity of each source

- comphance w'th this part before first use. annually, and following repair. The g

-(4) Date and time of the measurement; radionuclide and its estimated activity, and the measured activity of each test heensee shall:

2 (1) Calibrate all scales with readings (5) Initials of the individual who made sample expressed in microcuries, a up to 1000 millirem per hour with a

" the record.

description of the method used to radiation source:

3 35.57 Authorization for calibration and measure each test sample, the date of (2) Cahbrate two separated readings reference sources.

the test, and the signature of the on each scale that must be calibrated:

Any person authorized by I 3511 of Radiation Safety Officer.

and this Part for medical use of byproduct (e)If the leakage test reveals the (3) Conspicuously note on the material may receive, possess, and use presence of 0.00$ microcurie or more of removable contamination, the licensee -

instrument the apparent exposure rate.

the following byproduct material for shalk from a dedicated check source as check, calibration, and reference use:

(1)Immediately withdraw the sealed

- determined at the time of cahbration' (a) Sected sources manufactured and source from use and store it in and the date of calibration.

distnbuted by a person licensed accordance with the requirements in (b) When calibrating a survey pursuant to { 32.74 of this chapter or Parts 20 and 30 of this chapter; and instrument, the licensee shall consider a equivalent Agreement State regulations point as cabbrated if the indicated and that do not exceed 15 millicuries exposure rate differs from the calculated each:

35-8

- July 31,1991 (reset) s.

=-

D" 3O 5cF PART 35 MEDICAL USE OF BYPRODUCT MATERIAL 1

(b) To identify its contents, a heensee 3 require that the individual performms (2) File a report within fise dap of the shall conspicuously label each syringer i, the sur ey immediately notify the leakage ted with the appropriate NRC or syrmge radiation shield that contains

[ Radiation Safety Officer if.

Office hsted m 130 6 of this chapter, a s>ringe with a radiopharmaceutical.

7 contamination exceeds the trigger lesel

, with a wpy to Director. Office of Nuclear The label must show the

~ J

Ataterod Safety and Safeguards LLS.

radiopharmaceutical name or its (h) A licensee shall retain a record of

' Nudear abbreviation the c!mical procedure to each survey for three yean. The record i Regulator) Commimon ' Washington.

be performed. or the patient's name.

must include the date of the survey, a DC 205% dnrnbmg the equipment (c) A licensee shall require each plan of each area surveyed. the trigger mvehed. the test results. and the action individual who prepares a g level estabhshed for each area. the taken radiopharmaceutical kit to use a syringe

-y detected dose rate at several pomts m radiation shield when prepanng the kit each area expressed in milkrem per and shall require each individual to use -. hour or the removable contamination in

~

a syrmge radiation shield when

? each area expressed in disintegrations adimnistenng a radiopharmaceutical by per minute per 100 square centimeters (f) A licensee need not perform a injection unless the use of the shield is the instrument used to make the suney leakau test on the following souices:

contramdicated for that patient.

or analyze the samples. and the mitials (1) Sources contaming only byproduct of the indigidual who performed the material with a half life of less ihan 30 i 35.61 Vlal shleids and labels.

days; f a) A bcensee shallrequire each

-sun cy.

(2) Sources containing only byproduct individual preparing or handling a vial

~

material as a gas; that contains a radiopharmaceutical to (3535 Release of patients containing (3) Sources containing 100 microcuries keep the vialin a vial radiation shield.

radiopharmaceuticats or perrnanent or less of beta or gamma-emittmg

'"'P'*"

(b) To identify its contents. a licensee material or 10 microcunes or less of shall conspicuously label each vial (a) A h'censee may not authonze -

alpha emitting material; radiation shield that contams a vial of a release from confmement for medical (41 Sources stored and not being used' The licensee shall. however. test each radiopharmaceutical The label must care any patient administered a such source for leakage before any use show the radiopharmaceutical name or radiopharmaceutical until either:

its abbreviation.

(1) The measured dose rate from the or transfer unless it has been leakage-patient l$ less than 5 milbrems per hour tested withm six months before the date i 35Jo surveys for contamination and at a distance of one meter; or of use or transfer; and

, ambient radiation esposure rate.

(2) The activity in the patient a less s

{

(5) Seeds of iridium-192 encased in 2

(a) A 1 censee shall sune) with a than 30 millicuries.

A ng n nbbon 4 radiation detection suney instrument at (b) A bcensee may not authonze x'

(g) A bcensee in possession of a 2 the end of each day of use all areas release from confinement for medical

sealed source or brachytherapy source 1 where radiopharmaceuticals are care of any patient administered a shall conduct a quarterly physical o

routinely prepared for use or permanent implant until the measured ins entory'of all such sources in its.

administered.

dose rate from the patient is less than 5 possess on The hcensee shall retain (b) A licensee shall survey with a millirems per hour at a distance of one each mventory record for five years. The D-radiation detection suney instrument at $ meter.

ins entory records must contain the least once each week all areas where model number of each source. and senal l 35.80 Technical requirements that apply '

number if one has been assigned, the

[*

waste is stored.

5 ',,Ne,#'

identity of each source radionuclide and its nominal actinty. the location of each

!c) A licensee shall conduct the A heensee providmg mobile nuclear source. and the signature of the surveys required by paragraphs (a) and medicme service shall:

I be Radiation Safety Officer.

(al Transport to each address of use d

s s lo u0 lim (h] A licensee m possession of a only synnges or vials containing -

scaled source or brachytherapy source P h "

prepared radiopharmaceuticals or shall measure the ambient dose rates (c) A licensee shall establish radiation -

radiopharmaceuticals that are intended quarterly in all areas where such dose rate trigger levels for the surveys for reconstitution of sources are stored. This does not apply required by paragraphs (a) and (b) of radiopharmaceutical kits; to teletherapy sources in teletherapy this section. A licensee shall require that (b) Bring into each address of use all units or sealed sources in diagnostic the Individual performing the survey byproduct material to be used and.

devices, immediately notify the Radiation Safety

- before leaving. remove all unused 7

Officer if a dose rate exceeds a trigger byproduct material and all associated til A bcensee shall retam a record of level

-waste; each survey required in paragraph (h) of (e) A licensee shall survey for (c) Secure or keep under constant

this section for three years. The record removable contamination once each survell!ance and immediate control all

. ? must include the date of the survey, a week all areas where byproduct material when in transit or at

plan of each area that was surveyed, the radiopharmaceuticals are routinely an address of use:

5 measured dose rate at several points in prepared for use, administered, or (d) Check survey instruments and.

each area npressed in millirem per stored.

dose calibrators as described in il 35.50 hour5.787037e-4 days 0.0139 hours 8.267196e-5 weeks 1.9025e-5 months , the survey instrument used. and (f) A licensee shall conduct the and 35.51, and check all other the signature of the Radiation Safety surveys required by paragraph (e) of this transported equipment for proper

~ Officer.

section so as to be able to detect function before medical use at each contamination on each wipe sample of address of use; p 35 60 syringe shields and labels.

2000 disintegrations per minute.

(e) Carry a radiation detection suney (a) A licensee shall keep syringes that (g) A licensee shall establish meter in each vehicle that is being used

contain byproduct material to be removable contamination tngger levels to transport byproduct material and.

3 administered in a radiation shield, for the surveys required by paragraph before leaving a client address of use. -

j (e)of this section. A licensee shall survey all radiopharmaceutical areas of 35 9 July 31,1991 (reset)

. ~

V' ~'05(d) 35 bDn PART 35 ' MEDICAL USE OF BYPRODUCT MATERIAL E use with a radiation detection sursey.

measurements of uptake. ddution. or pacent adminishat'ons un>fer the 4 meter to ensure that all

- est.retion for which the Food and Drug departure in an auddable form and I radmpharmaceuticals and all associated Administration IFDA) has accepted a avadable for mspection for a per od of 5 7 waste have been rernned, "Notire of Claimed Insestigational n years.

t~ -

bernption for a New Drug"(IND) or 3 (3) Nothing ir _tha secuen relaves the -

(f) Retain a rnord of each sursey approved a "New Drug Application" X bcensee from rnmp!ying with other

~

required la parnraph (ej of this sect on (NDAF E whtaUe NRC. l'DA and other re&ral for tmee years The record must melude j 35.120 Possession of survey instrument. $ or Statt irgulabons posernmg the s

duti n igenerators and prepaw.m of y the date of the suncy, a plan of each A bcensee authorized to use

W k "

! area that was surve>ed. the measured byproduct material for uptake. ddution.

I dose rate at seseral points in each area end excretiori studies shall have in its

? of use expressed in milbrem per hour, possession a portable radiation i 35.204 Permiselble molybdenum 99 concentration.

the instrument used to make the sursey, detection survey instrument capable of and the initials of the individual who detecting dose rates user the range 0.1 (a) A licensee may not administer to performed the suney.

milbrem per hout to 100 millirem per humans a radiopharmaceutical hour.

O containing more than 0.15 microcurie of j 35 90 Storage of volatites and gases.

4

$ molybdenum @) per millfcurie of g Subpart E-tmaging and Locallration

[ technetium 99m.

g A licensee shall store volatile (b) A licensee that uses molybdenum-8 radiophatmaceuticals and radioactise x i 35.200 Use of radiopharmaceuticals.

99/ technetium-99m generators for e

gaseti m the shipper's radiation shield

generators, and reagent kna for Imaging C

I and container A licensee shall store a

? *nd locattention studies.

P'epanng a technetium-99m radiopharmaceutical shall measure the multi dose container in a fume hood (a) A licensee may use any byproduct en c ncentrah n in each after drawmg the first dosage from it.

material in a diagnostic g,

radiopharmaceutical or any generator or

, i 35 92 Dec apin-storage, reagent kit for preparation and (c) Alicensee that must measure (a) A licensee may hold byproduct diagnostic use of a radiopharmaceutical g material with a physical halidife of less containing byproduct material for which a d" sur d

or t r 4 than 65 days for decay m storage before the Food and Drug Admmistration has years The record must include. for each y d:Sposalin ordmary trash and is esempt accepted a Notice cf Claimed V elution or extraction of technetium 99m, from the requirements of i 20 301 or. for investigational bemption for a New a the measured activity of the technetium w

$ licensees implemenhng the provisions of Drug (IND) or approved a New Drug expressed in milheuries, the measured

^

il 201001-20 N01. I 20 2001 of this activity of the molybdenum expressed in -

)

cens 11 elute generators mict cunes, the ratio of the measures chaptn d R and prepare reagent kits in accordance o

',*E *,i bd n p C (1)lloids b> product material for with the manufacturer's instructions.

j decay a minimum of ten half-Inves-technetium, the time and date of the pl hiomf ors byproduct material at the measurementiand the inibals of the container surface before disposal as (ci! ) from Augat 23,199J. to August ordmary trash and determines that its a m3, a hcenm may depart from the

._IndisiduaI who made the measurement.

n U

Y8 structions for vluting

~

radiodctnify cannJt be d:#tmguiihed from the background radiation level pmrators and prepanns reagent kits i 35.205 Control of aerosole and gases.

m

? with a radialmn detecuon survey meter for which FDA has approved an NDA, la) A licensee that administers A set on us most sensitive scale and wuh muhd that the licensee has a wrinen radioactive aerosols or gases shall do so directne made by an authorized user q in a room with a system that will keep 2 no interposed shielding.

physican that directs a specific e airborne concentrations within the p) Remotes or obhterates all departure for a particular patient.or A limits prescribed by il 20.103 and 20106 7

patients. or for a radiopharmaceutical, 5 of this chapter. The system must either.

radiahon labels. and ll) Separates and monitors each and which includes the specinc nature

be directly vented to the atmosphere generator column individually with all of the departure, a precise desenption of through an att exhaust or provide for radiatmn shieldmg removed to ensure the depar; art ud a brief statement of collection and decay or disposal of the m

that it has decayed to background 3 the reasons why the departure from the aerosol or gas in a shielded container.

radiahon level before disposal

f manufacwrer's instructmns for

~

i 7 (b) A licensee shall retain a record of E preparing the radiopharmaceutaal'

[ (b) A licensee shalladminister -

each disposal permitted under g w uld btam medical resuhs not

-i radioactive gases onlyin rooms that are paragraph (a) of this section for tnree cenwise attainable or wodd reJace E at negative pressure compared to =

years The record rnust include the date mediCGI D5h Io particulut panetts A surrounding rooms.

O of the disposal. the date on which the bnaun of their medical conditan. If the - t E byproduct material was placed in duthor red user physician determ' es m

(c) Defore receiving, using;or storing a that a clay in preparing the radioactive gas, the hcensee shall

. storage. the radionuchdes disposed. the y sursey mstrument used. the background rado2phaymaceuucal m order ta make a--

calculate the amount of time needed dose rate, the dose rate measured at the wnuen directae would Popardce the after a spill to reduce the concentration e

surf ace of each waste container, and tFe panent s health becauw of the e in the room to the occupationallimit -

- name of the individual who performed emergency nat.o e of the patient,s i listed in Appendix B to Part 20 of this medical <;ondition the

_the disposal, chapter.The calculation must be based a

l" Subpart D-Uptake, Dilution, and f$t$.n n$ec n the highest activity of gas handled in o

a it e'

? " * "8

'"'"""'I

): Encretton The authorized user Physician shall room, and the measured available air rmke noun n f this determination in exhaust rate.

$ i 35.100 Un of remopnarmaceuticals to, Ih* "UII"' d'I*CId * "iIh* 3 WorkiDR (d) A licensee shall make a record of uptake, dilution and escretion studies.

- h A licensee may use any byproduct jfc "n the calculations required in paragraph j

a p

m materialin a radepharmaceuncal and directise ar'd a record of the number of assumptions. measurements, and c

for a diagnostic use involving July 31,1991 (reset) 35 10 l'

i

-h a

M M3@

'PART 35 MEDICAL USE OF BYPRODUCT MATERIAL

~

8 ' calculations made and shall retain the h record for the duration of use of the 13$.220 Possession of survey

$ area A licensee shall also post the instruments, tr calculated time and safety measures to A licensee authorized to use I be instituted in case of a spill at the area byproduct matenal for imaFmg and

of use, locahzation studies shall have in its b

possession a portable radiation

detection survey instrument capable of -

detecting dose rates oser the range of

0.1 millitem per hour to 100 milhrem per

hour, and a portable radiation-

- measurement survey instrument capable

of measuring dose rates over the range 1 milbrem per hour to 1000 millitem per

hour, Subpart F-Radiopharmaceuticals for Therapy

~~.

6 35.300 Use of res.opharmaceuticals for -

therapy.

(al A licensee may use any byproduct materialin a radiopharmaceutical and for a therapeutic use for which the Food.

and Drug Administration has accepted a

" Notice of Claimed Investigational hemption for a New Drug" (IND). or approved a "New Drug Application" (NDA). The beensee shall comply with the package insert instructions regardmg indications and ruethod of administration, tb)(1) Frora August 23,1990, to A : gust 23.1993. a heensce may depart from the package insert insituctions regardmg mdications or meibed of admmistra' on fe a radiopharmaceutical for which,

c I DA has appres ed un NDA. prouded 5 that tne euthorned unt phpician E makes a rccord of the departure wh.d E mclades the specific nature of t!.e

$ departure and a bnef statement of t!.e reasor.s why the depar6te wou!d ot'ain medical results not otherwise attainable er would reduce medical risks to pet!cular patients becaue of the:r med. cal condmen 1.kenseen are not authorized to depart from the manufacturer's ir:structmns for elutmg a

- generator or preparmg any kit for a radiopharmaceutical for therapy.

(2)The licmee sha:1 obtain this record within 3 wuriing days of the admm:stration and keep this record and a record of the number of patient admmistrations under the departure m

-an auditable form and available for n:n,ection for 5 > earr

.J) Nothing in this section relieves the lkensee from ccmplying with other opphcable NRC. FDA (including requirements goserning the submissicn of an IND), and other Federal or State regulations governing the use of radiopharmacet;ticals for therapy.

[ (e) A licensee shall check the 1 35.310 safety instruction.

j operation of reusable collection systems (a) A licensee shall provide radiation R each month, and measure the ventilation safety instruction for all personnel

$ rates available in areas of radioactive caring for the patient receiving

gas use each six months.

radiopharrnaceutical therapy and i_.

35 11 July 31,1991 (reset) -

>r PART 35 MEDICAL. USE OF BYPRODUCT MATERIAL hospitaltred for crimphance with i 35 75 rnumabir contaminauon is less than of this chapter To sat afy this m disintegrahons per nun

pn M

, confirm that all sources hne been requiretacht. the mstruchon must.

, square centimeters and

remmed The hcensee may not release N describe the beensee's procedures for 4 (1) Panent control (al Measure the thy roid burden of p frorn r_onfit ement for medical case a g pahent treated by temporary implant 2 - - (21 Vmtor control, enh indwidual who helped prepare of guntil all sources hn e been remos ed p) Contammat un control administer a dosage of lodme-131 withm

+

three da)s after udministermg the (b) A hcensee shall retain a record of 7 -(4) Waste controls.nd p)Nouhcanon of the Radiation

% dosage. and retam for the penod patknt saneys for three years Each Safety Ofhu r in case of the patient's E" or,qmred by "120 401h ](1) of this chuter g rec rd must mclude the date of the re for hcensees im;>1ementmg the y sun 4 the narne of the patient, the dose

~ death or medical emergency.

" prousions of ll 20.1001-20 :401.

p rate from the patient expressed as

[ (b) A hrenner shall keep for three year 6j 20 :10edal of thni chapter a record of

milbrern per hour and measured at one a a het of individuah recenmg mitruction each thytold burden rnensurement,its

meter from the atient. the sutt ey E required by paragraph b) of this sechon.

date. the name of the indmdual whose instrument use and the trutials of the a descript on of the instructmn. the date thyrmd burden was measured. and the n of instruction. and the name of the initials of the individual who rnade the

.mdnidual who inade the survey.

mea surements-7 35.406 Brachrtherapy sources mdnidual w ho gave the instruction.

,O Inv entorY' (b) A bcensee shall nonfy the

~

l 35.315 Safety precautions-Radiation Safety Officer immediately if (al Prornptly alier remosing them from (a) For each patient recehing the patient dies or has a medical a patient, a hcensee shallieturn radiopharmateuhtal therap) and emergency.

brachytherapy sources to the storage.

hospitalird for compliance with I 3515

$ 35 320 Possession of survey area, and count the number returned to of this chapter. a heensee shall:

instruments.

ensure that all sources taken from the (1) Provide a private room with a A licensee authorized to use storage area have been returned.

(b) A licensee shall make a record of prn are sanuary facihty; b> product matenal for brachythetapy source use which must s

(2) Post the patient's door with a radiophartnaccuncal therapy shall has e include:

i "Radioattivt Matenals" ogn und note in its possession a portable radiation (1) The names of the Individuah on the door nr in the patient s chart detecuan survey instrument capable of permuted to handle the surn.

where and how long unfors may stay in detecung dose ratn over the range 0.1 (2) The number and activity of sourtes the patient s room.

m threm >cr hour to 100 milbrem per

~ rermed from storage, the patient's (3) Authorire visits by inda-iduals

hour, an( a portable radianon

name and room number, the ume and under age 1H only on a patient by.

measurement survey matrument capable 4 date they were remosed hom storage, patient basis with the approval of the

of measurmg dose rates oser the range 1 x the number and actatty of the sources authonred user after consultation with mdlitem per hour to 1000 millirem per -

in storage after the remosat and the the Radiation Safety Officer,

' hour

. imuals f the indnidual who removed o

Subpart 0-Sources for the sources from storage:

(4) Prompth after admmistration of Drachytherapy (3) The number and actiuty of sources the dosage, measure the dose rates in 5 35.a00 Use of sources for returned to storage. the patient's name conoguous restricted and unrestricted brachytherapy.

ad m m nect, b m and date areas wah a radiation. measurement A htensee shall use the followm.

they were returned to storage the A

sunev metrument to demonstrate sources in accordance with the number and activity of sources m compfiance with the requirements of manufacturrr s radiation safety and storage after the return. and the initials E part 20 of this chapter, and retam for handhng matrucuono:

of the mdnidual who returned the i tnree yean a record of each nuney that (a) Cesmm 13? as a sealed source in sourcn to storage.

includes the ame and date of the suney, needles and uppbcator cells for topical (t) Immediately after implanting

". a plan of the area or hst of pomts mtershtial. and intracavitary treatment sources n a patient the licensee shall

~ surveyed. the measured dose rate at I CNet:

make a radiation sune) of the patient several pomts expressed m mdlirem per (b) Cobaltfo as a scaled source in and the area of use to confirm that no hour, the instn ment used to make the needles and applicator cells for topical sources have been rmsplaced. The sun ev, and the mihah of the mdividual.

interstitial and intracavitary treatment hcensee shall make a record of each w ho inade the sun ey.

of cancen

, survey.

(c) Cold 198 as a valed source in

~

O (5) Either monitor matenal and items (d A heenne shall retain the records removed from the patient =s room to -

seeds for interstinal treatment of cancer;

! reqm) red m paragraphs (b) and (c) of (d) tridium-192 as seeds encased in determine that their radioactivity cannot nylon ribbon for mterstitial trutment of i section for three years.-

be distinguished from the natural cancer; background radiahon level with a s.

(e) Strontum4:0 as a sealed sourre in radianon detechon survey instrument an apphcator for treatment of superficial j 35 410 Safety instruction.

~

set on its most senutne scate and with 4e conditions: and la) The licensee shall provide 2 no interposed shieldmg. or handle them (f) lodine 125 as a sealed source in radiation safety instruchon to all i as radioactive waste.

{

(6} Provide the panent with radiation

_ seeds for interstitial treatment of cancer. personnel canng for the patient undergoing implant therapy. To sathfy a-safety guidance that wdl help to keep 2 this requirement. the, instruction must E

M PadetW o a scaled mrc,~

I desertbe:

'; radiahon dose tohousehold members and the pebhc as low as reasonably -

& m mds fm imromal treatment of 2 -(t) Size and appearance of the achievable before authorizing release of ' concer i

w brachytherapy sources:

the paHent.

- (2) Sale handhng and shieldmg

. (7) Survey the patient's rnom and r*135A04 fielease of paUents treated with instructions in case of a dalodged private sanitary facihty for rernovable hmpway hplanta.

r u,,

i contamination with a radiahon detee' ion survey mstrument before (a)Immediately after removing the

3) Procedures for pahent controh assigning another patient to the room.

1 last temporary implant source from a (4) Procedures for usdor control and -

The room must not be reassigned untd

patient. the licensee shall make a 1

radiation survey of the patient with a

{

July 31,1991 (reset) radiation detection survey instrument to l

35 12

- - - - =.

I" PART 35 MEDICAL USE OF BYPRODUCT MATERIAL w

r g {51 procedures for notification of the rates os er the range 1 millitem per hour (b) Making any change m the location t 1000 milbrem per hour-of the teletherapy unit withm the i d es or s a ned a r treatment room;

~S' SU "

f (b) A licensee shall retain for three (c) Usmg the teletherapy unit in a O ears a record of indanduals receiving agnosa manner that could resuh in mcreased 5 ) instruction required by paragraph (alif

~

1 35.500 Use of sealed sources fo, radiation levels in areas outside the I this section, a description of the diagnosis.

teletherapy treatment room.

.- mstruction, the date ofinstruction and

the name of the individual who gave the A bcensee shall use the following (d) Relocatmg the teletherap) unit; or sealed sources in accordance with the (e) Allowing an individual not hated Linstruction manufacturer's radiation safety and n the licensee's hcense to perform the g

1 35 415 Safety precautions, handling instructions:

duties of the teletherapy physicist.

m b (a) For each patient receivmg implant (a)lodme-125. americium 241, or i 35.6 to Safety instruction.

E{ therapy, a licensee shall:

gadobrnum 153 as a sealed source in a (a) A bcensee shall post instructions device for bone mineral analysis; and at the teletherapy unit console. "Io -

(1) Not quarter the patient in the same (b) lodine 125 as a sealed source in a satisfy this requirement, these room with a patient who is not receiving portable imaging device.

Instructions must inform the operetor of. '

g radiation therapy unless the licensee (1) The procedure to be follow ed to

% can demonstrate cornphance with the i 35.520 Availability of survey instrument.

ensure that only the patient is in the e

requirements uf i 20.105(b) or, for beensees A licensee authorized to use N

treatment room before turning the e

d implementing the prousions of byproduct material as a sealed source 4 primary beam of radiation on to begin a -

$ li 201001-20 2401. I 201301(a) of this for diagnostic purposes shall have l treatment or after a door interlock chapter at a distance of one meter from available for tase a portable radiation interruption; the implant; detection survey instrument capable of (2) The procedure to be followed if:

(2) post the patient's door with a detecting dose rates over the range 0.1

( ) The operator is unable to turn the "Radioactiv e Matenals" sign and note mdhrem per hout to 100 milbrem per primary beam of radiation off with hour or a portable radiation controls outside the treatment room or 3 on the door or m the patient's chart measuremd sun ey matrument capable any other abnormal operation occurs; where and how long visitors may stay in f measunng dose rates over the range 1 and S the pat.ent's room; 4

(3) Authonze visits by individuals

$ mithrem per hour to 1000 millirem per (U) The names and telephone numbers 2

hour. The instrument must have been of the authonred users and Radiation

under age 18 only on a patient by.

m patient basis with the approval of the 3 calibrated in accordance with ! 35.51 of Safety Officer to be immediately I

th,s part.

contacted if the teletherapy unit or i

author zed user after consultation with the Radiation Safety Officer: and Subpart 1-Teletherapy 2

(4) Promptly after implanting the (b) A licensee shall provide.

matenah suney the dose rates in

{ 35 600 Use of a seated source in a instruction in the topics identified in contiguous restncted and unrestricted teletherapy urat.

paragraph (a) of this section to all areas with a radiatior, measurement The regulations and provisions of this duals who operate a teletherapy

, suney instrument to demonstrate subpart govern the use of teletherapy

? comphonce with the requirements of units for medical use that cont 6in a

$ part 20 of this chapter, and retain for sealed source of cobalt.60 or cesium-137.

(c) A hcensee shall retain for three three years a record of each survey that

[ years a record ofIndividuals receiving 2

includes the time and date of the suney,

{ 35.60s paintenance and repair instruction requtred by paragraph (b) of L 3 a plan of the area or hat of pomts

'e strictions, g this section, a description of the suneyed. the measured dose rate at Only a person specifically licensed by

instruction. the date of instruction, and ses eral points espressed in milbrem per the Commission or an Agreement State-

[the name of the individual who gave o

hour, the instrument used to make the to perform teletherapy unit maintenance instruction sursey, and the initials of the individual and repair shalh who made the survey-(a) Install, reloca te, or remove a -

I 35.615 Safety precautions.

(5) Provide the patient with radiation teletherapy sealed source or a

~

safety guidance that will help to keep teletherapy unit that contains a sealed (a) A licensee shall control access to the teletherapy room by a door at each -

rad:ation dose to household members source; or -

entrance.

and the pubhc as low as reasonably (b) Maintain. adjust. or repair the achievable before releasmg the panent source drawer, the shutter or other (b) A licensee shall equip each if the patient was admin:stered a mechanism of a teletherapy unit that

- entrance to the teletherapy room with -

permanent implant.

- could expose the source, reduce the an electricat interlock system that with (b) A licensee shall notif> the shielding around the source. or result in (1) Prevent the operator from turning 4 the primary beam of radiation on unle'ss 7 Radiation Safety Officer immediately if -

increased radiation levels.

3 the patient dies or has a medical

$ each treatment room entrance dooris

' emergency.

I 35.606 License amendments.

' cIosed:

z 6 35 420 Possession of survey Instrument.

In addition to the changes specified in (2) Turn the primary beam of radiation I 35.13 of this part, a licensee shall ff immediately when an entrance door '

e 7

A licensee authorized to use apply for and must receive a license is pened:and-byproduct material for implant therapy amendment before:

(3) Prevent the pnmary beam of shall have in its possession a portable ra aun m being tumd a foHowmg-radiation detection survey instrument (a) Making any change in the an inte enuphon ud aU =

capable of detecting -dose rates over the treatment room shielding.-

treatment room entrance doors are range 0.1 millirem per hour to 100 closed and the beam on-off controlis millirem per hour, and a portable reset at the console, radiation measurement survey instrument capable of measunng dose 35 13 July 31,1991 (reset)

- - ~.

~--

PART 35 - MEDICAL USE OF BYPRODUCT MATERIAL (c) A h(ensee hhall equrp eath h 135.630 Dosimetry equipment-.

the correctmn factor that was (a) A heenne shall have a cabbrated determmed from the cabbrahon or entrante to the teletherapy room with a o

beam condition indicator Imht.

l doumetry system asadable foi use. To comparison or the apparent (orret. tion td) A bcensee s, hall tratab n each i satisfy this requirement, one of the factor that was determmed frorn an fol mtercompanson. the names of the

{j (lowmg two conditions rnust be met teletherapy room a permanent radiation individuals who performed the -

monitor capable of contmaously cahbrated bstem must has e been

1) The a

**P""'""

momtoring beam statu*-

y the Nat.onal Insutute of DJ A toduition momfor must provide Standards and Technology fnt rco paior et ng was sisible noine of a teletherapy umt or by a cahbration laboratory sanctmned by a cabbration laboratory -

- malfunctwn that results m an exposed atcredded by the American Association or radiologic physics center accredited g or partially nposed soune, and must be oI Physicists m Medicine (AAPM) The by AAPM' observable by an individual entering the cabbration must have been performed y

teletherap) room-within the previous two years and after j 35 632 Futt calit> ration measurements.

(2) A radiation morofor must be any servicing that may has e affected (a) A bcensee authonzed to use a

+

equipped with a backup power supply system cabbration; or teletherapy umt for medical use shall' separate from the power supply to the

- (2) The system must ha$e been perform full cabbration measurements teletherapy umt This backup power cabbrated within the previous four on each teletherapy unit:

supply may be a battery sptem years. eighteen to thirty months after (1)Ilefore the first medical use of the pl A radiation rnomtor must be that cabbration, the system must have unit: and checked with a dedneted check source been mtercompared at an (2) flefore medical use under the for proper operation each day before the intercomparison rneetmg with another following conditions:

teletherapy unit is used for trealment of dosimetry system that was cabbrated (il Whenever spot. check patwnts within the past twenty four months by rneasurements indicate that the output eg theNational Institute cf Standards and differs by more than 5 percent from the

~

(4) A bcensee shall mMntam a record y Ttxhnology or by utput obtamed at the last full of the check required by paragraph y a < abbration laboratory accredited by cahbration corrected mathematically for th" AAPM The intercornpanson.

radioactis e decay; 4 (dip) of this section for three years The w

record must include the date of the

$ rm etmg must be sanctioned by a (iij F llowmg replacement of the E check. notatmn that the mordtor rahbration laboratory or radiologic souru r foU wmg reinstallation of the cthera y und in a new locaHon:

% indicates when its detector is and is not physics center accredited by the AAPM,

~

' exposed, and the imtials of the.

T he results of the intercomparison (iii) F lowmg any repair of the mdiudual who performed the chm k rnectmp must have InJicated that the A teletherapy umt that includes remos al of T

cabbration factor of the hcensee's a the source or major repair of the (5)If a radiation mondor is s3 stem had not changed by more than :

c mp nents associated with the source "Posure assembly; and inoperable, the hcensee shall require percent. The hcensee may not une the any individual enfermg the teletherapy intercompanion result to change the UI^'I"""I'" ' "'d"8""'

room to use a suney instrument or cahbration factor. When intercomparing

}"bb M4hrg wd audible alarm personal dosameter to dosimetry systems to be used for h

f th momtor for any malfundmn of the cahbrating cobalt 00 teletherapy units.

[3$"b at on easuren en s md'st incht source nposure mechanism that may the hcensee shall use a teletherapy urut determinahon of.

result in an nposed or partiah) with a cobalt +0 source. When exposed source The mstrument or mtercompanng dosimetry splems to be (1)The output within 13 percent for the range of field sizes and for the dosimeter must be cMked woh a used for cahbrating cesium 137 distance or range of distances used for dedicated check soune for proper teletherapy units. the bcensee shall use medical use:

, operatmn at the begmmng of each day a teletherapy umt with a cesium.137

. (2) The comcidence of the radiation j of use The licensee shall keep a record field and the field mdicated by the hght nource.

g as descnbed in paragraph (dl(4)of this beam locahzing device:

sectmn.

(b)The beensee shall have available p)The uniformity of the radiation 2

(6) A hcensee shall promptly renair or for use a dosimetry system for spot-field and its dependence on the 4

2 replace the radiation momtor if it is check measurements To satisfy this onentation of the useful beam; inoperabic.

requirement. the system may be (4) Timer constancy and knearity over R) A bcensee shall construct or equip compared with a system that has been

- the range of use; exh telethernpy room to ermit cabbrated in accordance with paragraph (5) On.off error; and contmuous observation o the patient (a)of this section.This comparison must

-(6) The accuracy of all distance from the teletherapy unit console durmg have been performed within the measunng and localization devices m irradua tion:

presious year and after each servicmg

- medical use..

2 that may have affected s3 stem (c) A hcensee shall use the dosimetry I 36 620 Possession of survey Instrument.

$ calibration.The spot. check system may system desenbed m I 35 ti30(a) to A bcensee autherard to use

be the same system used to meet the measure the output for one set of byproduct matenalin a teictherapy unit

. requirement in paragraph (a) of this nposure conditions. The remaining shall has e in as possession either a

secuen.

radiation measurements required in portab!c radiation detection suney (c) The licensee shall retain a record paragraph (b)(1) of this section may be instrument capable of detecting dose of each cahbration,intercompanson, made usmg a dosimetry system that rate over the range 01 millirem per hour and comparison for the duration of the

, indicates relative dose rates.

l.

to 100 milbrem per hour or e portable _

bcense. For each cahbration.

[ d) A licensee shall nuke full radiation measurement suncy intercomparison, or comparison. the j ca(hbration rneasurements required by instrument capable of measurmg dose record must include the date. the model rates oser the range 1 mdhrem per hour numbers and serial numbers of the g par-graph (a) of this section in to 1000 mil!irem pet hour.

matruments that were calibrated.

u mtercompared. or compared as required }

by paragraphs (a) and (b) of this sectmn.

July 31,1991 (resct) 35 14

N##

PART 35 MEDICAL USE OF BYPRODUCT MATERIAL ar eordance w ab either the procedures (2) On off error; The record must include the date of the ter mnmended by the Suennhc (3)1hc tomculence of the rad,4 hon spot.cheti the manufacturo s nan.e.

Conanm on Radianon Dmimdr> of fwld and the fwld mda ated b) the hght model number, and vnal number for the An enum Anoriation of Ph> sit ms beam localizmg da a e.

both the teletherap) un t and source the m Me Inme that ate dewnbed in H) Tbc m ura< > of all divance manufacturer's r,ame model number

/Yq m t t : Els a and B4p Vol menurmg and loulanhon dewes used and senal number of the metrument 16 No a 197L pp ;?m or by in for medial use.

used to menure the output of the hp ) of th Radstwn The9p) l5) The output for one 13 pnal set of teletherapy unit. an assessment of hmer Commmer of the Aniencan Asw ochon operahng con <htmns measured with the imeanty and unitanc), the calculated of phments ir Mmbcme d at are dosimetry s3 0< m deu ribed m on off error, a determination of the s

destr6ed m h!n al PA)su s Vol 10

? I 35 630{b) of this part. and k coincidente of the radiation field and q No 619n pp 741-771. and Vol 11 No f

(el The difference between the 7 the held indicated by the bynt beam i 11%4 p 213 (Ih,th of these re'erences measurement made in paragraph (b)(5)

$ locahring deWre. the cakulated on off

,s

he r been ap;iros ed for mcorporatmn

" of tha sectmn and the anticipated

+ error. the deterrnmed at. curacy of cath d by teferenr.e by the D rectot of the

output. espressed as a percentage of the 3 distante measunng or localization Q Federal 1% ster Copies of the antCpated output h e, the salue device. the differente between the doc uments are as ailable for mspot hon obimed at last full cabbratmn anhcipated output and the measured or me be obt.uned from the U 5 t orreord mathematically for phy sical output. notations indicatmg the Norlur Pegulatur) Comnussa n. Pubhc dm e l operabihty of each entrance door Ih umer,t Room 21m L Street NW" N A br mwe sh..tl perform electrical mterloclo each eler tncal or Waha4 on DC 20%5 Copes of the t

rneasure n'ents required b) paragraph (al mechamcal stop. cach beam condihon do< un,ents are ab.o on fi!c at the Office of he sedmn in nu ordante with inditator hght. the viewing sptem and of the I ederal Regnter,11001. Strret procedures establahed by the doors. and the signature of thr NW INm Mo!. Wnhmgton DC 2006 k k h' W N sdMdd mdmdual who performed the periodic A nehre of an) change m the material wdl be phbshed m the l'ederal d not actually perform the spotchec k spot <hed

,,g Reghter.}

k) A hiensee shall hee the 1 35 636 safety ch,os for teletherapy

{c) A b:enwe shall corrett h kthg Mw m resicw the rrtults mathemancolh the outputs determmed

$ of each spot < heck withm 15 dos. The (a) A licenne si.all promptly check all in pauraph Ibyl) of this sectmn for i tekthnm p@cm shall pmniptly

8) stems hated in 135 tu4(d) for proper phm al det ny for mteruls not a nonf5 the h6n.we m woting of the fur $ction after each installahon of a e u re hna one month for t obahe or en

reds d euh spota heck The hcensee

telethnapy source and af ter making any nmnths for c enom-137

shall k eep a copy of each written

% change for which an amendment is (Il full t ahinatmn measurements requel M parwaph (a) of this sechon notif canon for three years

" requ red by 135 W (a)-{d).

i (b)If the results of the checks reqmred and phy sn al det.a) correchons reqmred

- WI A hcensee utbnzed to me n in paragraph (a) of this sethon indicate by pareaph le) of this ecctmn must be perhmed b the htensee a telethnap) teletherapy umt for medical use shall

the malfunchon of any system specified 3

b ""

imm ufm spu hb of exh m 6 35 034(d), the hcensee shalllock the (u) A bcensee shidl retam a ret ord of telethnapy fa'cihty once m each control t nsole m the off position and nde month tha esce proper not use the umt except as may be r

eut cahbrano1 for the duratma of use of the telethenc umt sourte 1he n Mmnof.

netessaryi repair. repMce, or check record must im bde the date of the m i dnut inwrWb M enh

-the malfunctmnmg sy stem

} cahbratom the ;anufadurer s name' telotherapy room entrance:

mode! cumber, and senal number for inal or mecbmcal ops (c) A hcenser shall retain for three both e e tektherap) umt and the source.

d b h pp d Wm m years a record of the facihty checks the mWel numbers and senal numbers of pnn d d eon

followmg installation of a source The 7

endmn d som Musmg anStion y record must mclude notations indicatmg of the metruments med to cabbrate the dW

- the operabihty of each entrance door teletherapy umt. tables that destnbe the M

um on df

[ interl ck, each electncal or mechamcal outpu' of the out oser tty range of field 1

stop, each beam condition indicator mes and far the range of dmances used 5

m bndinon inddor hghts on hght the uewing system, and doors. and m rathanon therap), a determmanen of the cmra nience of the radiahon field

-h hem y umt on tb cuntid the sigtmture of the Radiation Safety and the f1 eld indir6ed by the hght beam tonsole, and m the facdity;

-Off cet-b abzmg deucr an mseement of hmer (O DC * *d 8) "h*'-

~

hnennt) and consMncy, 'he ulcolated (5) Treatment room doors from maide 135 64 t h<tistion surveys for telatnerapy on u.Inror the eshmated accuracy of "d M * **"M "M ** d each datance muunes or locah2atmn (N Ekctncally asmted treatment (a) Defore medical use, after each deure, and the gnature of the town ders with the teletherapy unit installation of a telethera y source, and "I"CIMCSI O*'t luf""d OII-

" after making any change or which an teletheup> ph)sicist.

P (e) A bcensee shall arrange for prompt ; amendment is required by ( 35 noe (a}-

1 35 634 Pedode spot-checks-repair of any s) stem identified in 4 (d). the licensee shall perform radiation tal A bccr ce authonzed to use paragraph (d) of this sect on that is not a surveys with a portable radwtion teletherap) umts for mechca! use shall operating properly, and shall not use the 1 measurement survey instrument perform output spot-chs.ks on each teletherapy umt fo!!owing door interlock

' calibrated in accordance with I 35 51 of telethera;n umt orme in each calendar malfunchon untd the intnlock system this part to senfy that:

month that mclude determmahon of.

hn been re paired.

(1) The maumum and everage dose

11) Timer constantw and timer rates at one meter from the teletherapy hneant) user the range of use; f) A bcensee shall retain a record of source with the source in the off position y ea(ch spot-check required by ;1aragraphs and the collimators set for a normal j (a) and (d) of this section for three years treatment field do not exceed to 35-15 July 31,1991 (reset)

M MlOnlO

.O M l t:li PART 35 MEDICAL USE OF DYPRODUCT MATERIAL

) il M Ra$auon $6fety OW et.

l titfore beginning the treattnent program Ettept as presided in i 35101, the l mdhiem per bout and 2 mdhrem per the la ensee shell-hcensee shall require an individual p hour, respectmlr and 2 (1)1:ither eqwp the umt with stops or fulfdhng the responsibihties of the q (?) Oh the 'c!etheraH sourte m the h add additional radiaHon shielding to Radiation Safety Offner as provided in

( on position with the largest dinnaih

d. ensure compliance with ( 20109td of this i 35 32 to be an itidiudual who; ava;!able treatment f ald and with a th4 er or im N am epbnting Me (a)is certsfeed by:

t 3.n scattermit phantom m it e tr: mar 3 beam $

g

11) American Board of.llealth Phpas yf rediation.that-g 3 gg og,

in Comprehensive litalth Phpics,

12) Amentan floard of Radiology;

~

12) Perform the sur e) required by p) Amerkan Deatd of Nuclear tir n it str ted ras oIt to l 35 M1 again; and M'd'CID'*

cause personnel esposures m escess of (3) include in the report reautred by

{4) Arnetican Board of Science in the hmits speufied m i 20101 or,

) 35 645 the results of the trutial sun ey, N

edescr Hon of the modification made

'{r hied c re or q for hternees irvpletnent rig the g prousmr4 of Il 20 t(0140 2401 fi 2n 1201 to comp y with paragraph (a)(1) of this j

g 4 of this chapter, and acuan and de rauha M de second (b) lies had classroom and laboratory E (u) Radianon dose quantities res umt

4 trainmg and experience as follows

$ tirne m umestrated areas do not esceed

- Ib) As an alternause to the (1) 200 hours0.00231 days 0.0556 hours 3.306878e-4 weeks 7.61e-5 months of classroom and the brmts speufied in i 20105f bl requirements set out in paragraph (a) of laborator) trainmg that includes, or. f or lkenners implerrntmg the

& a nWon a konsee may requot a (t) Rec" Alon physks and prouuons of il 20 m01go;401 l 201:t01 litente amendment under i 20.10$(a) ot.

instrumernation of this chapter, for heennn implementing the provmons u) Radiation protection; I " ***""

I"I"I '

and measurement ofradioacta tty:

~

i

'I V

(b} !I the results of the sune)s

% this chapter that authorins radiation Ovl Radiation biology: and required in paragraph ia) of this sectinn "lesele in unrotricted areas greater than v) Redwpharmaceuncal chernlitry; It those permitted by i 20105!bl of this i r e iIe i f th r 8"

s mp enung the (2) One ) ear of full time experience as

- j hnot speufted in that prograph. the

$ lla[r[rll r at na at at a

{a l 201301lal of tha c.hoter.

A t

rdn t a h ur licensee may not begin the treatment supervision of the individualidentified (1) Enept as may be riecessar) to

" repait. tepiace, or test the teletherapy pr jam until the hcense amendment as the Radiation Safety Othcer on a

""I""

2 Commission or Agreement State hcense unit shieldmg of the treatment room I that authorizes the medical use of Df

$ 36 645 Reports of teletherapy surveys, L6hieldmS checks, tests, and measurements.

' byproduct materlah or 2 Until the liunsee has receised a A licensee shall mail a copy of the (c) De an authorized uset identifwd on p,

g (ec)ific esemption pursuant to l 20 501 records taquired in il 35 636. 35 641,

th' hC'nsM'8 UfMO sp 135.M t Training f or experienced hg or for hcensees imp!rmentmg the 35 643, and the output from the Stadtstion $,atety Orficer, provisions of li 20 1001 4 0 2401.1 20 130) teletherapy source espressed as An individualidentified as a 4

8 of this chapter, toentgens or rods per hour at one meter Radiation Safety Officer on a O

from the source and determmed durmg Commission or Agreement State hcense (c) A bcerare shall retam a record of the fv!! cahbrahon required in i 35 632.

before October 1,1986 need not comply the radiation rnessutements made to the appropriate Comminion Regional with the training requirements of followmg installation of a source for the Ofhte listed in 130.6 of this chapter duration of the hcense.The record must within thirty days following completion i 35 900 include the date of the measurements.

of the action that irutiated the record 1 35.910 Training for uptake, dilution, and e8cretion studias-the reason the sun cy to required, the requirement.

Estept as provided in !! 35 970 and manuf acturer a name, model nutnber

j 36 647 Five-year inspection.

35 9?1, the hcensee shall require the and senal number of the teletberapy (a) A hcensee shall have each authortred user of a A

unit, the source, and the instrument used teletherapy unit fully inspected and raciopharmaceutical in i 35.100(a) to be to measure radiation levels. each dose

$ serviced during telethere y source a physician who; rate measured around the teletherapy

- replacement or at interva e not to (a)Is certified in:

q h source while in the off position and the exceed five years, whichever comes (1) Nuclear medicine b), the American g aserage of all measurements, a plan of first, to assure proper functioning of the D ard of Nuclear Medicine; the areas surroundmg the treatment source esposure mechanism.

'8"

C '"

8Y N 3 room that were survened, the measured (b)This inspection and servicing may Amencen Board of Radiology, or dose rate at several points in each area ib f '* d b

" 8""' "

8Y

$r[c[th[icnnd d o by the by the American Osteopathic Daard of espressed in milbrem per hour. the p

cutculpted maximum quantity of Commission or en Agreement State.

8"'

radiahon over a penod of one week for (C) A 1 C'"*" ' hall k"P 8 T'CO'd of (b)1las had classroom and laboratory C U 8h ""

8 traming in basic radioisotope handhng -

each testncied and unrestricted area.

and the signature of the Radiation durauon of the bcensy The record must techniques applicable to the use of S' afety Officer' contain the inspector s name, the prepared radiopharmaceuucals and inspector a license number, the date of supervised clinical esperience as i36443 Modificat6cn of telatnerapy unit inspection, the manufacturer's name and gottowy or room t>efore t>eginning a treatment model number and serial number for (t) 40 hours4.62963e-4 days 0.0111 hours 6.613757e-5 weeks 1.522e-5 months of classroom and program.

both the teletherapy unit and source 8

!aboratory training that includes:

[ (a)If the survey required by 135.641 list Ic mp nents inspected, a hat of (i) Radiation physics and 9 Indicates that an individualin an comp nents serviced and the type of instrumentation:

N unrestricted area may be exposed to service, a ist Ic mp nents replaced.

(ii) Radiation protection;

" levels of radiation greatet than those and the signature of the inspector.

(til) Mathe:natics pertaining to the use.

6 permitted by 120,105(b) or. for hcensees Subpart J-Training and Experlance (ivl Radiation biology; and and measurement of radioactivity; 8 implementing the provisions of 1120100140 2401, t 201301 of this chapter, Requiremente (v) Radiopharmace utical chemistry:

35 16 and July 31,1991 (resel).

U PART 35 MEDICAL USE OF DYPRODUCT MATERIAL l2120 baan of superused thmcal thed s for proper ope ratwn tl surs ey (2) $uperused climr al e spenence espnern ur der the superusion tsf an meters under the supertnnon of an authonred -

authonteJ user and that mdudes On) Calculating and safris prepanns user at a rnedical insutution that bi Osatiorr ng pahr res and traiewsg patient dossars indudes:

ther tase hwnn to deterrnme their (n) Ustr'y admmatratise antrols to

0) Use of iodme.131 for diagnosis of suMWy fui radansotops daposis.

prnent the maadnanistratmn of th)rmd funchon and the treatment of L. product enatorial; hyperth)toidism or cardiac dpfunction hmPahons. or antramditations.

3 in) %rleomt tbe suitable (v) Usma protedures to contain spilled in 10 indinduals: and radm; brit.at eut.cals and calc ulatmp by product matenal solel) und using 00 Use of iodir e.131 for treatment of and measunns the domes proper decontammetwn procedures, and th) told carcinoma m 3 indMduals.

lui) Adtmn,st img dosages to patients (vil Elutmg technettuin 99m from 31932 traming for treatment of and using sm radinhon shalds, i;enerator systems, measunng and

,$,ypermyro6 diam, in ) Cohaburatag wth the arthorited totin the cluste for mol>bdenum 99 Escept as provided in l 35 970. the user m the mterpretsuon of radasotope and a urmna contaminahon, and kmn shah imite the authorized test resahs and protusmg the eluate with reagent kits uur of only lodine 431 for the treattnent (si patient fo!!owup. or to prepare ter hnettum*9m labeled of hyperthyroidism to be a physician klIfas sut r essfull) cor pieted a six radmpharmatruncals, and 4

M*""

Dd inanth trainms praram m nudear

13) 500 houte of supervised chnical an who has had daurt.om and medame as peri of a ira;tung program npent nce under the suf>crvision of an oraw un ng in basic radmisotope that hn been apprused by the authorized user that inc udes.

~

"E Anreditauen Counal for Graduate 01 Esammms pat ents and teviewing

"" "" 8 hiednal Educatmn and that intf aded their case histories to determme their d supervised dirutal

" g g]an I"

clanroorn and laboratory training. work sumbiloy for radioisotope diagnosis,

" I" esperience. and sopr:rused chnical hmdations. or wntraindicahons.

(a) 80 hours9.259259e-4 days 0.0222 hours 1.322751e-4 weeks 3.044e-5 months of dassroom and npenente m all the toms idenulied m N gej001*81y* 'uitaye laborator) training that indudes:

paruraph ibl of 'ha secunn' radmphartnattulicals and calculatmg

{1) Radiaticq ph) sics and and measuring the donget instrumentation; i 35 920 Training f or imaging and localisation studies (iii) Administermg dosages to patients (2 Redmuon protection, and using syririge radiation shields; (3 hiathematics pertaining to the use Eu ert n prosided iti i 35 fl70 er Dy) Collaboratmg with the authorized f, and measurement of radioactivity 35 9*1. the hcensee shall require the H) Radiat on biology; and

? authanted user of a

u cr in the interpretauon of radmisotope 4

i test results: and g (b) Superused clinical esperience f radmpharmaceuhnah unerator, or h) Pahent followup, or

, under the supervision of an authorized e

4 regent kit in 135 2tgal to be a user that includes the use ofiodine 131 phpician w ho 2

(c)lias successfully completed a sie a

month trainmg pregram in nudear

for diagnosis of thyroid funcuon. and the o

!d b cernhed m:

11) Nudeur medame by the Arnencan medicine that has been approsed by the treatment of hyperthyroidism m 10 Accreditation Council for Graduate mdividuals.

Boatd of Nudrar hieditme.

(2) Diagnothe radiology by the hiedical Education and that induded Training for trutment of thyroad Amentan Board of Radmlogy; or dassroom and laboratory training, work

,i,35,9H

,,n,,,,

(3) Dinnosuc radiobgy or radiology esperience. and supervised chnical Except as provided in i 35 970. the bs the Ali.cncan Osicopathic Dourd of esperience in all the topics iden4fied in kmn shall require the authortred Ra diology; or paragra;)h (b) of this section.

user of only todme.131i r the treatment tblilas had dannoom and laboratory 635930 7tainmg for therapeutic use of of thyroid carcinoma to be a physician tra nte4 m bnw radimsotope handimg

'"#i' Eh * ' * * * * *# * !* '

with speaal espehence m thyroid icchniques apphtable to the use of Escept u prodded in i 35 9 0. the darne who has had classroom and prepared radic harmatesticals.

hansee that require the authorized laboratory training in boic radioisotope generators an reagent kits supervised use f radiopharmaceuticals in i 35 300 hand!mg techmques apphcable to the work esperience. and tapervised to be a phpician who:

use ofiodme.131 for treating thyrrid chmcal openen e as follow,.

(a)Is ceruhed by:

carcmoma. and supervised chnical Ol;oo hours of dassroom and

. O)The Amencan Board of Nudear emperience as follows:

Ia) 80 hours9.259259e-4 days 0.0222 hours 1.322751e-4 weeks 3.044e-5 months of classroorn and laboratory tra nmg that includes:

hiedicine, or

0) Radiation physics and (2)The Arnerican Board of Radiology laboratory traintng that includer m radiology or th rapeutic radiology; or

. O)Radiatmn phystes and instrumenta tion:

Oil Radiaboa protechon:

instrumentation; bu) htchemanes ertainmg to the use (b)If as had dasnoom and laboratory (2) Radiation protectiorn and n,easurement o radioactmt);

traming in basic radioisotope handhng (3) hiathematics pertaining to the use e

Os) Radiopharmac runcal chemistry.

techniques apphcable to the use of and measurement of radioactivity; and and therapeutic radmpharmaceuticals. and (4) Radtahon biology; and (v) Radiannn biology; and superv 4 chnical expenence as

1. - "I" (2) 500 hour0.00579 days 0.139 hours 8.267196e-4 weeks 1.9025e-4 months of superused work foUowr; under the supervision of an authortred espenence under the superusion of an O) 80 hours9.259259e-4 days 0.0222 hours 1.322751e-4 weeks 3.044e-5 months of clanroom and user that includes the use of lodme 131 authonzed user that indades:

laboratory traming that includes:

ea t of Ayro cardnoma

0) Ordenng, receiving. and unpacking

0) Radiation physics and fn'3 g

radioactive rnaterials safely and instrumentation; performing the related radiation

' Di) Radiation protection; I 35.940 Tr.ining for use of brachytherapy l

(iii) hiathemahcs pertaining to the use Sources.

surseys.

and meourement of radioactivity; and Euept as provided in i 35 970, the

06) Cahbrating dose cabbrators and diagnosu:: instruments and performing liv) Radiation biology; and.

licensee shall require the authonted 35 17 July 31,1991 (reset) a

_,a_.,__

..u

PART 35 MEDICAL USE OF BYPRODUCT MATERIAL user el a brath> 9.erap) sm n e hated m hi) ScIn ura the preper bre %therap)

(1) Radiahon phy sns, matte mabc s i M to for therap) m he a pb su,an sourc es and done and method el

[ertainmg to the use and measurement who a d % ra s t r a t wn of radmactaity. and mstreentahon-(al15 (ef tbed in hilj Calt Uldtirj the dobe. and

( ) Redishon biolog)n (1l Rodo iny m the ro;Nhc raioiegy p) po,t.ednunmrahon fMlowup and

% " idahon pmtechon: and la t) e An#ra an It mrd of Radd FE reuen of < ne hmones m (4beratwn (4)1rsinmg m the use of the deuce (2) Rdotion om ohv) !3 the with the authenred user.

for the uses requested Ame ncan Oste e; atha 14ard of Radso!on i 36 941 Trainirig for ophthalmic use of i 36 9 % Training for teletberapy.

(3) Radohn wi'h s; Poal. a%n m strontium 90 Escept as preuded in 6 35 r0. the radiotheat y. n a lhtnh Mbw of the Eu ert as prouded in i 35 r0, the in ensee shah require the authonred f aculty of km.hoh g)" or i el:ow of the ht ent.cc shall require the authorited user of a scaled source hsted m i 35 tm Rop! Cdlue of katolog)'by the user of onh stronhum 90 for c.phthalmic in a teletherapy unit to be a ph)nician

. or w ho:

(4) Therapeutit radabg>

radiotherup> to t>e a physician who is in Canadan Roy al Colk ge cf Ph)snians the actne practice of therapeutic (alls cerbfied in and Surnons, or radmlegv or ophthalmology, and has W Radmiogy or derarnuc radmkgy (b)ls m the acme prachte of had das'eroom and laboratory training by the American Board of Redmlogy.

therapeubc radiology. has had in bmt radioisotope handhna (2) Radiahon oncology by the dassroom and laborator) tronmg m ter hniques appbcable to the use of Amt ncan Ostwpathic Board of k

redmwtope handhng techmques ihontium 90 for ophthalmic Ra diology; W Radiology. with spe

'.adm0+rapp as a Ny,tish(tahratan inpilow of apphr able to tht %rapesta use o' raJmtherary. and a penod c,f superused brat h thr rapy souru $. superused work rlinic al trammg in ephthalmic 3

espmeme and superwd (bnnal raJMhrrary as follow s F aculty of Radiology or 1 ellow of the RM al Cohge d RaMogn w espuu nu ns idowa pi) 24 hours2.777778e-4 days 0.00667 hours 3.968254e-5 weeks 9.132e-6 months of dustoom and (4)1herapeutic radiology by the (1):m hours of dmtcom and 16 Mon %

the mdudes Canadian Ro> al College of Phy ronans labmator) tr,onia that mdude, (1) Radiation S)nas and and Surgeons: or 01 Radiahon N sic $ and

*U*f"I8 h n instrumentahnn:

(b,:

.he actne prnhce of hil R adubon ; rotuhun.

12I R"dichon protec t on; therapeubc radmlegy. and has had Im) Mathemata pertainmg to the use (3) hiathematics psrtammy to the use dassroom and laboratory training m a..d menurement of rada taits and and rneasurement of radmactnity; and basic radiotnotope techmques appinalde 2 Os) Radiatum twingy.

(4) Radiahon bmlogy; to the use of a sealed source in a

(21 sm hours of supen ed work (b) % perused t hnu al traming m

? teletherap) umt, supervised work esperience unde r ihr Wen mon of an

ophthalmic radetherap) under the 4 esperience, and supenised chmcal 5 authormd usn at a meda at asutuhon caterir cc as follows-superusmn of an authortred user at a e

1 that mduJes I rnedical mshtution that indudes the use (1) Om hours of dassroom and U)Orderms n murW and unpadmg

' of strontium 90 for the ophthalmic laboratory traimns that includes-e radmactne matenals safel) and treatmer9 of fne mdmduals that D) Radiahon phpics and performmg the rdated radiahon mclude s.

instrumentation; s on e) L (1) Esammaten of enh indmdual to Oil Radiahon protectiori:

(n) Chedmg sune) rneiers for proper be treated, bii) Mathemahes pertaming to the use "l e'8 h00-(2) Calculat on of the dose to be and menurement of radmactaity. and ImlISeparmg mplanung and admmistered, Ov) Radiatmn biology:

(2) 500 hours0.00579 days 0.139 hours 8.267196e-4 weeks 1.9025e-4 months of supenned werk remourg ned d nourt es (3) Admmm:stwn of the dose. and Osl Mamtamire runnmg ms entones esperience under the suren nion of an W F llowup and reuew cf each authonred user at a medical mshtuhon o

of matenal on hand (v) Usmg admmattata e conttols to mdnidual s case h:sfory' thai mdudes prnent the rnedmmistratwn of j MMO Traming for use of sealed li) Reuew of the fullcabbratwn byproduct matenal und sources for $agnosis, measurements and periodic spot thrcks; lull'smg emergency prwedures to M pt n prouded m i 35 970. the (n) Prepanne treatment plans and control b> produri rutenah and ht ensee shall require the authonred

(* d 8h"8l*8I**"Ih* *

(3)Thrre pars of sur enised chmcal user of a sealed source m a deuce hsted On) Using admimstratn e mntrols to espenence that mdudes onc year m a formal trammg program appros ed by the in i 35 500 to be a phnician, dentist, or prn ent rnisadministrations; Rendenn Renew Committee for P g^

g' bv} lmplementing emerFency procedures to be followed m the esent Radmhd of the Ao redi ahon Couned (a)is confN in.

t of the abnoi

,pershon of a for Grajuate Medical Educahon or the W Radmkgp diagnesht radmlogy. or teletherapy u. or console: and Ccmmittee un postdoontal Trainmg of therapeunc radiology by the Amencan b) Checking and usmg suney meters.

the Amencan Osteopathic Association.

Board of Radioleg>;

and dnd an addihonal tWo seBrs v[ chNcgl

{ } Nudear medinne b) the Amencan (3)Three scars of supenised chnical expenenc e m therapeinc radiology Board of Nudear Medicine. or espenence that includes one year m a under the superusion of an authonred (3) Diagnostic radiology or rudiology formal training program approved by the user at a medicalinshtunen that by the Amencan Ostenpathic Doard of Residency Review Committee for

mdudes, Radiology; or Radiology of the Accreditation Council pl Esammmg indniduals and (b)llas had 8 hours9.259259e-5 days 0.00222 hours 1.322751e-5 weeks 3.044e-6 months of dnsroom and for Graduate Medical Education or the teuewmg their rane hamnes to laboretory training in basic radionotope Comrr ttee on Postdoctoral Trainmg of determme their suitabihty for handimg techniques specifically the American Osteopathic Associahoa brach> therapy treatment. and any appbcable to the use of the deuce that and un addihonal two years of chnical hmitatmns or contraindicahons:

includes:

esperience in therapeune radiology M

July 31.1991 (reset) l i

--_-,-__.-----__-------------_,----------,--,,-.---_,------____--,----------__----------_----~,___.,.__-.---,---------__,,,1

l15.wie PART 35 MEDICAL USE OF BYPRODUCT MATERIAL -

E999 1

under the supersmon af an authorded willan the fis c years precedmg the date user at a medicalinsutuhon that of apphcation or the inda adual must indudes-hat e had related connnuing edut ation (illAamming indmduals and and espenence since the required i

- reviewing their tase hatones to determ ne their suitahdity for trairuf F arid espenente was completed teletherapy treatment, and any Subpart K-Enforcement l

hmitations or contraindicationsi j

(ii) Selecting the proper dose and how g 3 g,,,

y;o,,g,n,'

et is to be adtninieered.

f al An injunchen or other court order i

09) Calculaung the telethetary doses inay be obtained to pro $ubit a violation and collaboranns with 'he authorited of any provision of user in the review of pahents' progre**

p) The Atom)c Energy Act of 1954. as i

and consideration of the need to modify

amended, originally presor bed doses as warranted by patients' rention to pl TWe 11 M the Energy radiation: and Reorpnuahon Aci of 1974. as amended.

(tv) post administration followup and resiew of tase histories.

(3) Any rule. regulation. or order Issued under these Acts.

I 3l 961 Training for teletherapy physicist-(b) A court order rnay be obtained for The Drensee shall requite the the pa) ment of a civd penalty imposed teletherspy physicist to be an individual for violation of

.[

Who:

(alls er rtified by the American Duard (1) Sectwns 53. 5?,62 til Bl. 82,101.

of Radiology in' 103,104 107, or 109 under section 234 of.

f1) Therapeutic radst legical physirs; the Atomic Energy Att of1954 as t

l2) Hoenten tay and gamma ray amended; SenWdbNw

'E" " 8 UAd ra and radiurn ph) sics: or (4) Rad!o' logical physica: or (3) Any rule, regulanon.or order

lb)lloids a master's or doctor's W inued under these Ada.

7 degree in phplu. biophpics.

j of(any bcense issued under these Acts.

4) Any term. condition, or hmitabon

radioloim al phpir4 or heahh phs sics.

. and has cornpleted one year of fuh tirne a or

traming in therapeutic radiofr'Eical

{$) Any requirement fer which a phpics and an additional year of full hanse may be resoked under section Ume work esp *rience under the 186 of the Atomic Energy Act of 1954, as supervision nf a teletherapy phpkist al amended a medicallnstitution that includes the i

task a heted in (( 3% $9. 35 M2,35 034.

(c) Any person who willfully violates and 35 M1 of this part.

an) prraision of the Alumic Energy Act of 1954 as amended. or any rule, 1 35 970 Training for esperienced regulanon.or order issued under the Act authorized users.

may be guilty of a crirne and.upon Phpicians. denusts, or podiatrists c n&u n.may W punished by fine or -

idenuhrd as authorized users for the

. h"P'H' nment or both as provided by medical dental. or podiatnc use of law. Regulahons issued under the Act byproduct material on a Comminion of mclude reFulauens issued under sec.

Agreement State hcense issued before ICL and cited in the authority citation at April l.1987 who perform only those the beginning of this part for the methods of use for w hich they were purposes of sec. 223.

authorited on that date need not comply i 35.999 kasolution of confucting I

with the traming reqmrements of b"I'P"" I requirements during transmon period.

- If the rules in this part conflict with j 35.971. Physician training in a three the hansee's radiation safety progratn month program, as identf ed in its bcense, and if that

. A phpician who, before ju!y L 1984, hcense was apptoged by the began a three rnonth nuclear rnedicine Commnsion before April t 1987 and has training prograrn approsed by the not been renewed smce April L 198?,.

Accred:tation Council for Graduate then the requirements m the license will hiedical fducahon and has successfully apply < llowever,if that hceesee completed the program need not comply exercises its pnvileFe to make minor with the requirements of Il 35 910 or thanges in its radiaHon safety -

35 920, procedures that are not potenhally

{ 35 972 Recentness of training-important to safety under j 35 31 of this The training and espenence specified -

chapter. the portion changed must in this subpart must have been obtained -

comply with the requirements of this Part. At the time of hcense renewaland thereafter these adinendments to this Part shall apply.

'35 19

- July 31,1991 (reset) u -.

.a

~.

ML20126L573

Contents

Text

Dear Mr. Ellis,

Dear Syncor:

SUBJECT:

Dear Syncor:

Dear Syncor:

Dear Syncor:

Navigation menu

ML20126L573

Text

Dear Mr. Ellis,

Dear Syncor:

SUBJECT:

Dear Syncor:

Dear Syncor:

Dear Syncor:

Navigation menu

Search