ML20137R900
| ML20137R900 | |
| Person / Time | |
|---|---|
| Issue date: | 03/26/1985 |
| From: | Lesar M NRC OFFICE OF ADMINISTRATION (ADM) |
| To: | Mcelroy N NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| Shared Package | |
| ML20136D915 | List:
|
| References | |
| FRN-50FR30616, RULE-PR-35 AA73-1, NUDOCS 8509230676 | |
| Download: ML20137R900 (4) | |
Text
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Ra 73 =/
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4 [ i UNITED STATES 4 ,. 5' i NUCLEAR REGULATORY COMMISSION g
[ WASHINGTON, D.C. 20555
, Norm McElroy, NMSS bbS96IW Just a short note to confirm, in writing, the information I gave you concerning the number of beds for NRC medical licensees. This information was submitted to us in response to our survey of materials licensees.
2 No. Beds No. Licensees Cumulative No. L.
1-50 50 50 51-100 186 236 101-150 246 482 151-200 184 666
. 201-250 190 856 251-300 130 986 301-350 118 1104 351-400 _84 1118 401 + 360 1548 s
Let me know if you have any questions.
Michael Lesar
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8509230676 e50906 PDR PR 35 50FR30616 PDR 3
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[Aut4&PI MD CALENDAR YEAR 1984 (dys)
JAN FEB MAR APR MAY JUN JUL AUG SEP OCT NOV DEC
-TAT NRC 13'2 136 54 47 42 62 46 66 74 54 46 e i' New Licenses: /
-Rcvd NRC 9' 8 16 14 12 7 13 13 10 11 8 e f, 3 /23
- TAT NRC 66 77 46 56 55 63 58 56 56 56 70 '
Amendments: [
-Rcvd NRC 159 131 141 109 125 121 157 103 146 95 82 *
-TAT NRC 143 130 99 137 102 154 172 162 158 129 169 r/b R:newals:
~
-Rcvd NRC 36 30 34 37 36 32 41 37 54 39 34
-TAT NRC 51 41 53 117 29 33 39 86 30 135 28 JON Terminations: g/4,7,3
-Rcvd NRC 6 8 2 4 3 0 5 3 2 1 1 i-k?iJ (( S '!? 6) t v ),)), .
,9/ 3 if W g/ /l3 /J3
/f 6l7 A'?
A n72 40
764 Ot U (&S 14%ta Cef Teshnelium l Official Wmn:ral'hs UNI *NX J Q a sterile solution of pentetic a Jid that is completed uith propriaich dditril,suth that it prin des. count rateof atmut 20JRin
"'Te in Sodium Chloride It jection. It is suitable for o'unh Per minuie,atuut 23 mm tr. m one end ora 25. x mo mm
- ind mas contain buffert d
"^"""'"'"I"O'*"*'
" Ptoiln alhm "' ' hin """' ' "fnh' "naildo air. % P'"' P*' b". t he t hrom.niorram over i esclop e"Mtravenous administration, contains not Icw than 90.0 iercent innd not siure than 0.0 percent of the labeler amount of ""'Tc as the entetic acid comples espl essed in microcuries or
,i suitahie h rna of iime in awend og ibromaiopr.iphy. using ac-clone slut has been pmrcil with m6 pen Irce miroren for not lew than in minutes Allow the t hrom dopum io dtb ard deternune millieuries per ml at the liitn indicated in the lahehny. '"I'"" h * " "'"P " h d ""'" 0"""
Other chem.ical forms of ra lioactiyity do not eseced NN '"I""d'N radution deicctor d'.' Not less iha n 0 tr,"of Ihe total raihiutliun
, n,i.nd .n si. inn.ius riuctriainu *e p'>ini of arrlicana al 10.0 percent of the total rad oactivit) -
nini. zica distriweii. Inica inn acnoush beiwcen s mri .ind Padaging and storage Picserw i i ungic dose o 7 % m( i ol t he imetinin m a wluni c not ettecding 0 I miinto ibe containcrw at a temperature betwi en 2' .ind b. r m mulaple dose caudal sein of cash of two l$0-F a' .d 2 %g rats Approuniatcly W" W upiratina dale T he ciP'ratum d, te n ruis tater t han te lmieirs atter i " ' ' #" "
trme of manuf.ucture, bl.mmt mio a suitable contamer. Ib 4ect ihe amnuh, and plate the kidnet hver, puro.ntestinal trati and a In-g speunien of h!imu!.
labeling -l abelit toinclude the ollowing, m addition to the m- anurincly wcip hed. m wgurale. w table oiunimr sani.onerw a nd firmatkm specified for /dvling t uler Info tions (I): the time destrunne the raduuttnitb in unn. - lvr minute, in cat h wnt.iiner and date of cahbratum, t he aneu r.t 4 *1 c as tahded penhw atx!
with an appropnaic detettor uuni the same muntmr rcometry.
compiea espressed .w tneal mitin u res or mit rot unes and etnian- Dt crmine Ihe pertcntage of radm otnits in the k ednes,incr. and t ratkin en misrocuries or inallislaries per ini at the tisix of t.shle iti.iri. pntrinnteqin. l tr,iti b; the fortiin Li ItNI Ai/.l. in w hish . Is n alie the espiration date; .ind the stattmc m ,' "( 'a u t u m ltide.uti n e net radi.udiuts. m mCs, m the or 'an, and . n ihe iotal radauc.
Wterial? I he la beln.g inda.ates that en makmg das tre ukula- tiuty, m m( i inicssed, bot h terrn t< .I to 'np tron Iime 1 Atcomnc tions torrcttain h to be m.ide for i.nh.udise daa y a ml aiso imb- the percentage of radouttisits ' the bio.=1 bs the forinul.:
cates that the radauctise half-hic 4"*Ic ntiohours [inot /t/tli Hi n?(Is'yll/ I, m w he h /t a the nce rIndhutinns in plI(791): bet =cen 4 0 and 7.5 mCs. in the sprumen of ble!, ans . I is t he total r.afiiusin n s. m Osher requirements it mects th rtyuirements of'she tesa for G 'nict h d. bot h ,wnewd to innwon time. Hi is t he w ciyht, in RaJavrmlide rJents/'icutwn and /,adumu. tide, purstr under .L- p,of the bhut spetinwn. Ih n the ac'F ht, m p. of the rat, ami 0 07 Jium l'rrto hartaic T. Wm injn i on it mccis the requirements is the.nsumption that the tot.d blu al weight of the rat n 7'1 of the under injn saan (1).cscos that it mas be dntributed or dwpend total himly weight. Nw less than 1: th of the radnictiut) is found prior to completion of the test for Ntcrifsty, the latter test bemg m the kidney, not more than 1(fi of the radisuctisity n found m started on the d.n of rnanuf.icture, ar.d except that it h not subject the bhnul, not more than 'i tr; of Ihe radioactnity is h, ound m the to the recommendati m on liLme in G miainer. It meen aho the gastrointestinal tratt.and not omr:Ihan 5.tG of ahe radioactnity requirements for f*prugen. RaJm, irmu ul surstr. t iti<dogo.at Jn. is found in the liser tributi<m. and :E na rfor radusas av sts under leiknernmr ic Wm Other requirements -11 meets the requirennnts for RadionmlrJe frour Aiwrbare l'enterte Aad Gmpie s Injet tiam. identili< ation ,unt Radiamm hJic ,ur:tr under kinem l'crtei h-crrate 1. Wm inicilion. It meth aho the requircments under iniciti.un ( ),cscept that it nuy . < dntnbuted or dnpensed prior to completion of the test for Stermti, the latter lest being started ecimetium IjeC(ion Tcdium 99m GluceOtate So "a ' hc dc "I m' ""'' "'e ' .ad9 'c r' ' h' ' " " a"' '" bi" "" ' h' retommerut.itum on lidume en t a ntamer hay for radioacisiity 1 Ning a . unable wuniing assembly bec N /o ri.m of a Gmntmg .f urne/u i under Radma. tie rti ' k 21 ) ).
n-glycro.t i- detennine ihc radaminup nW per mi,of Icchnchum fe Wm Technetium gulo-1leptome m!. cchnenum *comples Tr t>-g/p eru-n-gaw-hcptonate
/~c wmple, Nahuin Quceptate Intethon M s sc of a caMrated system as de rested uruler Radina,in if r (N214.
o Technetium Te 99m %! um Gluceptate Injection is a sterile, ayucous solution, suitable for intr.svenous administration, of sodium ;!uceptate and stannous chloride that is labeled with """I c. It contams not icw
, Sodium Perfechnetate Tc 99m injection than 90.0 percent and not m we than i 10.0 percent of Periechnctic acid Hi"To M. s. hum sati.
the labeled amount of "*Te as stannous gluceptate . sodium perict hnerate ( Na%oa 12.f2nott.nl comple3 ey1rcued in microc rics or millieuries per ml at the time mdicated m the -abeling. It may cont n Salium Pettechnetate Tc 99m inicetion is a stetite antimicrobial agents and tuffers. Other chem.ain ical solution, suitable for inirasennus or oral adm.inistration, containing radio.tetive technetium (w,,l'e) m the form forms of radioac.tivity do not meced 10.0 percent of the .
totaI rad.mact mty.
of soth.um pertechnetate and sufhetent Liium C bloride to make the solution isotonie. Technetium 99m is a Packaging m.at starage- Presene i, singic41.ne ur in muhiple4tose radioactise nuclide formed b) the radioactive decay of containcrw at a temperature betwccn 2* and x*
b piral"uwi date 'Ihe cipirat nin itair n n.it iatcr ih.iii .ts hiiurs.itter mol)hlenum 99 Mol) hie'num 99 is a radioactive time of manufacture. N,gog. of mohbdenum and ing be fornied h the labeling-l.abel it to include the f;illowing. in addition to the in' neutron bombardment of molybdenum 98 or as a formatmn specified for tolvling a 3 der In/ccrions (I): the time Iiroduct of uranium fiwion. .
and date of calibration; the amoum of ""Te as labeled stannous k. lium Perfechnelate l^c 99m injection contains not glueeptate exprewed as total micr4uries or millicurics and con. less than 90 0 percent and not more thaa 110.0 percent cc:tration as mimicurieur millicories per mi at the time of c.di- ef the l,theled amount of"'"Te at the date and hour bration; the espratiam date and ti ne; and,the ytatement,
- Tau-y - g--Radmact.ve Wierial. T se labchng mdicates that in stated on the label. Olher chemical forms of"'"Te do
- j. mg dmaFc calcubtions, correcti in is to be nude for radautine not esceed 5 Iscreent of the total r.idioactivity.
,'(
.j y, and aho indicates that ihe r idioactive half hfe of""Ic i' a bours. Packaging and durage Preserve in single-dme or in multiple-dme conta mers.
~[ Pyrogen le meets the rcquiremen s of the l'irogen /, si (l's t ). npi,ation date ~finc cspiraimn date h not later ihan 4x hours aftcr pil(791): betwecn 4 0 and N.O. time of nunnfacture. t
,l Radiochemical purity - Place a me.hured volume of Inic(oon, ap- l abeling ifintended for intrasenoen use,labelit unh the infor. 1
/ i s
)
A .
f ' Y-
>XX ' O/Ji< ial Munognspit A l Technelium 165 mation specified for Lub</smg under in citums (1). I abelit alus a: t. of ut R u Ainost < a soit tus't HeiO s - Not more than to include the followmg- the time and date of cal.bratiim; the 0.8 pCi of all other beta and ramma cemiters per mCiuf technetium 8
amount of ***"Te awahum pertechnetatc esprewed as total mith- 99m h present at the amic of adminntratum. Not more than 0 001 curio a nd as tmlheuries per mi sm the date and at the time of cah. nCi of grow alpha impurn) pu mCiiJ inhnenum 99m n present braten; a statement of the interkled use, w hether oral or intrasenms at the time of adminhtratom the espiration date; and the statement. "Cautam RadL atis e l'3 reca It mcch the requirements of the Pirogen ten (151).
MalenalJ lf the injettnm has been psepared from rnoly bdcm"" 0:her acquiscimnts it mects the rcquirements under Irsjes tions 99 pn=luecd from uranium fiwa n, the label sintates 1he1.ibc!mp g i g em.pt iha ihe injethon rnay be dntributed or dhpensed prior ndicates that m nuking dosage cattulathms corretthm 6 to be ni me complAm 4 du ent for .Vti rdan the lauer test being mucd made for radhuctise dee.i), and alsi> iralseates th,it the radauctise on the 4 of manufacture, and cscept that it h not subject toihe halfI fei(
- Tc n t 0 hourt rnommendatam em hdume m ( ectmacr Radionuclide identifiution b,ec Radioaitigtr (M21)] It' Chemical purin gamnu-ray spatrum h identkal to th.it ro , sptumen of
- I alumirium O o be determined if wpirathm h .anomplhhed by eshibits a major photopeak haung an energy of 0.140 .
.in Me\lc almmnathat column in Ihe preparatmn of the injettiim) -
pil (793 ); between 8 5 ard 7.5. u a utu.u sino suo son t ilos Diwihe 15.17 mp, ae-Radioc hemical purity - Place a s olume of in ject hm, a pprornatcl) curately weighed, of aluminum potamum sulfate dialecahydrate diluted, such that it proudes a tount rate of about 2@oo sounts in watcr to make 1000 0 mi l'ath ml ofihn wlutum contams 2 pg per mmute, about 25 mm from one end of a 25- X 100 mm sirip of of A1 thromategraphie piper bee Chromatographi (621)) Des clop twor e in un' hptt 10 mi of,Ilumment standarJ udution into
- the chranutogram iner a suitable pcrital of time by .ncendmg cath of two 50 ml solunietne clash To cach flask add 3 drops of thromategraphy, uung a misture of 80 mlumes of acetime and 20 methst orange IS and 2 drops of to A ammonium hydroside,then
{
solumes of 2 3 bydroth!orw acid. Allow thethronutogram todr) add 0.5 Y hydrishlonc acid.dropwie, untd the udution turns red.
in air Determme the radauctiuty dninbution by v.anninF the To one flad add 25 ml of vahum thmplycolate lS, and to the other chrostutogram with a suitat'te colhmated radutam dcicetor. The llask ad,1 I ml of dnishum cthylene-diaminctetrancetate TS. lo radauttnity of the pertechnetate hand is not few than 95% of the cach nask add 5 mlof criochrome cyaninc 1S and 5 mlof acetate total r.ahiuctnity in the test pecimen. The R fsalue for the pct- butIer IS. and add w. iter to solume. Irnmesh.itely determine the technetate tand tapprinimately 0 9) falls withm i 10.tfl of the abwrbante of the solution containin; wahum thioglycolate TS at salue found for a known chum pertahnetate le 99m speumen the w.nclength of maumum abwrtunce at about $U nm, with a when determined under identical cimditions suitab!c spettrophi*mieter, usmg the wlutiam containing the di-RadionuchJic purity Lsmg a suitable counimp awcmbly f ue vuhum cihylenediammetetraatenate TS as a blank Repeat the i Artc. n.m of a C antine f ormh/t under Rado=ninit. (x21)), procedure using two 10-ml ahquois of Sothum Pertechnctate Tc i determme ihe radaustnity of cnh radmnuthd.c impuni). in p('i 99m injet t L m Caltulate the quantity.in pg per ml.of aluminum j per nW of tethnctium '19m. in the l'yecthm by inc of a cahbrated in ihe injation by ihe f..rmula 2tH T, /li t. in w hith le and Ts are swit m as dirceted umler Rudmai to ni (x21). t he alerhant rud the wdution funn t he injecthm and t he uduthm 9
' Ne imei tu.n preturcJfrom rei hni teum wm Jern eJJvmn parent o wnainmg ihe alumsnwn stand. rd, respctinely Ihe esmeentration moh Mcm,m W /.<med as a triu/t n/ nrutr,m /umhardment of of alununum um m ihe injettWm is not greater than 20 pg per ml
/ ,
it.,b/c m di Menkm f or injection prepared from nmlytmicnum 99 denved f rom the
/ j w et ) nos v At 99 T he prescnce of nelyhdenum 99 in the neutnm irradutum of stable molybdenum.aml not rrcater than 10 I j inycuum n shown by ituharasterntic Famnu ray spectrum. 'Ihe pg gwr eni for injection prepared from molybdenum 99 formed as
'Oi nei rrimnment photopeah of thh radmuctnc nuchde have cncrgics a result of ur.inium Imam.
of 0 ihl.0 740 and 0.7h0 McV. Mohbdenum 99 decan with a Mcthiict45I Aetone ( To be determmrd if separation is accom-rad %tne half hfe of 66 0 houn Tlic amount of molybdenum- phshed by liquki-liquid estrxtmn in Ihe preparation of Ihe injec.
99 is not Frcatcr than 0.15 pCi per mCe of technetium 99m per tion) - Place 1.0 ml of the inicction m a suitable cont.iiner, and adnumstered dow of the inicction,at the time of admmntration, ddute with water to 20 0 mi A412.0 mlof I A smhum hydruside, oHtt N We \1 s e stil iIV. W.usHIM ( l HHU IMPt,9 6 i H N nut, then adi 2 0 m! 44 0.1 N nhnc.dropwhc.and again mis. At The total amount of other gamnu-emittmg radumuchdie impuntics the same time, prepare a standard by placing 10 ml of a solution dies not cweed 0.5 pCe per mci of tethnetium 99m. and does not of methyl ethyl ketone (l in H00)in a dmdar container and dduting esned 23 pCi per admmhtered dme of ahe Injcohm at Ihe eime with waacr ea 20 0 ml. Add 2 0 ml of i N soeum hydroside, mis, of admmhtration. then add 2 0 ml of 0 i N bahne, dropwise, and ag.un rms. After law inm unn swerarcJ / rum an hrwnum 44m Jern cJ from parent 2 mmutes. she turbsdity of the test spetimen does not enced shat modihJen.sm 4YJormrJ as a result of uranium fisuun tinmma. of the standaid 10.1%)
and /wta, nutting impu ritect Away for radinartiday thinF a suitable tuuntmg awembly (we w n s mu u st 99 T he Iniecthm meets the requirements set &/n tion n/ a ('oumsny .f ormMr umfer /tadn=ninirr (K2I)).
fonh for ihe Inlection prepared h3 neutnm irradution of seable dciermme ihe radiuttmty. in m( i per ml. in %ahum Perinhnetate mo!>bdenum bec foregomg) 'lc 99m Injettum by use of a cabbrated system .n directed under p onu 131 ihe nni pronunent photopeak of thh rade.uttne /tadn=n tn ett (M21).
nuthde has an enerF) of OJ64 McV. lodme 131 decan with a radmine half-life of M 04 dayt I he tuncentratum of Whne I il n not more than 0 05 pCa per mCiof tnhneimm 99m. at the time -
or admim a ranon. I ccimet.ium Ie 99m I3yrophosphate gi t ot s u u 101 T he most promment photopeak of thh ra.
- dwstne nuchde h.n an cncrgs of 0 497 McV l uitwmum 101 g3ggg dnay s w oh a raduuu n e h.df-hfe nf 193 days l he sontent ration of ruthemum loi n not nmre than 0 05 pti per nfiof inhnetmm n Technetiuni Te 'Phn '> rophosphate injection is a 9%n. at the time of adminhtratmn sterile. ayticous solution. suitable for intravenous ad.
0 l)cternune the prtvnte.htrontmm k9 in t he IninidrMoin, d p's replu ghme ihm is IMded with inj,M pos I n u A9ntnen bs a omntmg ') stem .spprornate for the descuinn
.,.snrI t h containsof not h w th.in 10.0 parotu!.ite radutaint Stamtium M9 dnaw by a httumbsho with a
percent and not j
a nuumum energy of 1.441 McV. and a rjdpuctne half hfe of 52 7 anore Ihan i 10 0 percent t:fIhe Libeled amount of"'"Te days Strontium h9 may he presem in a concentration of not more as p)tophosphate expressed in niierocuries or niilli-th m 00006 pfi per mC of technctium 99m. at the tirne of ad- curies per ml at the litne indicated in the labeling, it
- 4 '""I " " " " 'n o apenh, buffers, reducing (x - Itht90 l)etermine the presence of strontmm 90 m the Injecuon by a counting sysicm appropriate for the deteuion of apents, and stabih./Crt Other cheintcal fornis of ra-particulate ra6atkmv Sinmtmm 90 decan hv a heta cmiwam with dioactisity do not exceed 10.0 percent of the total ra-a nuumum energv of 0346 McV.and a raduuctnc half-hfc of 27.7 dioacgigjg),
gears St rontmm 90 nuy be prewnt in a concent ratum of not more ihan u nono6 pCi per mCs of inhnetium 99m. at Ihe time of ad. l'adaging and sten age Presen e in single-dose or in muhiple dose minnt rat on containcts, at a temperature hetwecn 2* and H*
b