ML20127C602

Package Consisting of Commission Final Statement on Regulation of Medical Uses of Radioisotopes

ML20127C602
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Issue date:	11/30/1988
From:	NRC
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ML20127C585	List: IA-92-363, Package Consisting of Commission Final Statement on Regulation of Medical Uses of Radioisotopes ML20127C581 ML20127C602
References
FOIA-92-363 NUDOCS 9301140269
Download: ML20127C602 (2)

Text

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UNITED STATES NUCLEAR REOULATORY COMMISSION RULES and REGULATIONS TITLi it. CH APTER 1 CODI Of RDER AL MOULATIONS-ththof

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COMMISSION NOTICES POLICY STATEMENTS MEDICAL USES r

a4 rR 3242 euMM 2/9/r8 ie in the NRC Pubbe Document gg, gagggggg,g g t,m 2'W Roorn at Ill? H Street. N W., Wash.

ing'.on. D C, The NRC and Sta predecessor the Atomic rnergy Commisalon have teru-1 Stattsrtvt or Otstm Polter lated the reedical uses of radiotsotopes Regvfaf;en of the Medgef Use, ,(

ted;efsetepes; Statoenent of Gener, This NRC policy statr ment is in,- since 1948. AEC recognised that 5.hys&-

tended 14 Inforrn N RC liter. sees, othes etans hate the prirnait responsibility of Policy Tederal and State ager. ries and the for the protection .of their patiepta public of the Commission's general in- and designed its regulations attordahs-AO CY; Nucles.t Rerutatory Com' tention regardmg the replation of 17. De ph)sicians sere requised to tne the medical uses of radioisotopet licensed by the State, and their appD-ACTION Fina.1 Poucy stat.emesa It is espected that futute NHC sette- esble tratning and eaperience were files in the medical area, such na pro

• estJusted in coruuttation sith the Ad-

SUMMARY

The Nuclear Rerulatory mulgation of nee regulattons and de- visory Committee on the Medical Usee Commhalon (NRC) has the folloning seleptrent of cocptrathe triationships of Isotopes. Thta regulation has been 3,ohey statarment reg arding NRCs stih other rede rs) a g e ncies. t ill g rnerally orir nted tes ard sisl$ ting future role in regulatms the medical q uahf 4cd ph) siciera in dacharging uses of redsolsotopes. Tbts NRC policy fohon Based this onstatement of hRC p past esperience licy'he and t their responubilities to g>attents Hot-statement is intended to infortn NRC co nn ents and educe of the pubbe, e enuutmn M Al'C/NRC has st 11cmees. Other Pederal and Ptate other Tcdcrat a;enties. the States. end one time or another encompassed agencies and the public of the Com. NFIC's A ktsory Comrmat te on the restly eser) aspect of the delnery of mission a geners) Intention terardlag Medical L'ses of Isot 4es. the CmtrAs- rnedkal scrilces to pa-the regulation of the reedica] uses of sien has doel. ped the f

llning state- tients The broadest tegulation oc-rad:otaotopes. It is espected than tr.ent of ge r.eral pbey to g ide its reg. curred betseen 1962 and 1915, when future ERC betMtles 11 the medr.aJ utstion of the tr.edkal use4 of ration the Food and Drug AdrMnistration area. stich as promu4at6cn of mes res. top **

tfT)A) esempted itorn its s t4 Wtr e-ulations asid development cf toopers. 3. The NRC till continue to regulate all the relationships with other Feders) the tredical uses of radioisotopes aJ radiopharmaceutletis ' regulated by a4 E n at p ndatt LU foUot this statement of g p g gener AEC. During this period AEC refRIA%*

p u bhc' eJ the rad:stion safety of sorkers and EFYl CTIVE DATT. February 9. !Mg- the general pubhc and the safet) and 2 The NRC 3 tt! regulate the radj. efficacy of radiosethe drugs and de-FOR FVRTHER IN FORM ATION aticn safets of ratienta n here justified CONTACT b) the risk to paMenta and there vol. t,,g.utation ices althincluded respnt pr0 to patients.

duction ofAEC the untan standat or tempUance sub ndJctsotope, manuf acture of the final Mr. Edstro Podolsk. Othee of est stan at A su Ins equate.

ERandards Deitloprnent. U Ss Nucle- rsdjotethe drug product or dedee, dio-sr Rerutatory Commisston. Wash. 3. The NRC till minimLte intrusion tributtort use and dJposal of the prod-inston D C. 20555 (Phonr 301443 Into medical Juderroenta affecting pt- ueta, in 1975. the FDA tenrdnated Ibe -

5440s.. tients and tnto other are as traditional

• esemption for . endicpharmaceutleats.

ly cortstdered to tw a part of the prac- stating that it sould nos regvlste the SUPP!EMENTAL INIVPMAMOK tice of toedkine. safety and efficacy of sa d.oartJoe We NRC has developed the follestnf dru gt sith respect to patienta. t As three part pober statement ;egarding note.1 later to this statement, FT)A

- NRC's future role in regulating the *1mc 1.cemes re&ctetopes in three rate- docJ t.ot regulate the ph}sacian's rou.

sme@cet uses of radtouotopea On sones b> product source and specima nude- ttne we of rac.cpharmaceuticals 1 At Martt it.1978. the three part poucy mi matertal. The sme does not reculate nas' the same time NRC 3tthdres' frota statement a as published 60 the F1 rwa. uraus ocrums or accelerster produced rs- rerulattua radioacthe drug safety and aA Rsctstra H3 FR 11204) for pubbe diotwtopes The terra bomdmer merenal statLng that it sould regulate comment Coples of the pohey state. {'[,'"8,$,"n#j,',",$"

, ','$'$ eff.

the scy$ation ra asfety of the mothers ment mere aW in all FRC enedical 11- daunctae er esmsure to the rstatica snes. and the p@lic. The 1976 M ed.c t' ceruces. the States and 23 professional sent so the prwems or prodarte. or uttha:na Deuce Ascendmenta to the 7 cod. Drug sortelles. Federal agencies. and Inda- as-clal oudear matertat The term source and Costoette Act extended FDA's au-s edusta The comment pertad emptred nars etal me ar s til uraNum, thorium of anF tbority oser medical dnices tinchdhg May 16.1918. Tsenty4so comments tomtrinauun thereof, to ans ph3 skal er dellCeJ eont ajn'ng radlobethe matert-mere recched Nine comrnenters in.

sored all three parta of the po!!cy

'[,('*h [t m e$b  :

ala) in a a ny simf.ar to its authority our drun se more of it) uransum. tus thocium oc sun statement. f6ur commenteri oppose 11 ans comttnsuon thereof Sourts asetersal .NRC's authority to regulate domes-one part of the polley statement and does not include specta,1 auctemi esatertak tically the medscal mes of b3 product nine commenters addressed soectfle Spretal esclear metanal means e t) plutord- mat ertal is found in the Atomic tuues discussed la the March 17.1978 min. uranlurn ass. urumum entscried in the Energy Act of 1954. as amended. Foe rattnal Hectstra notice. The com. Lat*P' 333 8' 18 th' 18M*P' 733 o' 83 8 ^^F example. sect!cn 81 of that Act autho-ments are discussed in Section !!

"*#"' 'D " " F ^^# ' h' rtzes NRC "to tasue generaJ or specule

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• liternes to appbcants serking to use Copies of the comments rnay be exarn bwroduct rnatertal for * *

• med es]

therapy * * *? Section 81 directs NRC f

PS MU 1 November 30,1988 9301140269 920805 i PDR FOIA -

DAVIS92-363 PDR

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POLICY STATEMENTS etten as enay 14 r.ecessary to padde nosed s it h ratoarthe insterial, as As victed in the pn M ed pobey ressoratle adsurance of the:.r atlety

• ell as the serieral pubbe a he may be statt ment. hRC b put trg 3 the sar.

and effecther.eas TDA las not yet esposed to rad;ation as a result of that tous albrd be alth te ri.bration pro-t ad esthtient !!rce to Irnpletr_tr.t its tre at ment. are all rnemt,ers of the grams currrntly in ef fect or be.ng full authority to replate snedical d,. public to t e protect"d by NRC. drafted by other Fede rat. State and ettee contain'as b> produrt, act.rce of Ts o cornmenters ob)nted to NRC's profesalonal groupa. If the coserage spec'al nudear anater;al. Therefore, regulation of patient iadiation safetF proudsa by thnt programs is not ade.

NRC 403 fontinue to restrict phni trecause they bellese that NRC does quate to protect the patient from un.

rian's uses of these med:ral destces, not base the authority to regulate ra- nectua ry rad.ation esposure. NRC both for diatnoats sad therapy, to tient safety. They note that NRC's en. s 111 m erk sith th,s, g,oups to ocietop those procedures that NHC has deter. abling legislation does not speelfical1F e nes NRC proposed rule for the mined tin consultation sith its Addso- mentloo the radiation safety of pa. trainir g of allied health personnel.

ry Comtntttee on the Medical Uses (! tie nts. They belles e that patient There scre fhe comments on the Isotopes) to be safe and effective. safety is the respornibilfty of the phy' speelfat subject of nucleat pharmacles The Commission does not consider alcian, a resporutbility that cannot be tradiopharmaelest equipment calfbratiors, qualifications shared They bcIlese that the Commis One commentet urged NRC to dis r of paramedical persont.el or reporting 6 Ion is in error to equate patients sith tinguish bets een ra dioph ar mar t<ts to ERC misst.minfstrattorts of ra diose. the public and to consider patients ta

• orking in a ho*pital settie g and those the material to be exclushely the users rather than recipients of radio- s orking in a retall enstronment (com praellte of rnedicine nt a part of physt- sethe material mercial nuclear pharmacyt This corn-clan patient relationships. The Corn. Aa noted in the utlysis of the simi. rnenter also noted the ecmplealty of rnisalon tntends to serulate these treta las comment abos e, the NRC's oserrld. the probiers of definition then the of patient raiation safety s here justl- Eng conpeastonal tr.udate is to* pro. botptt al tased radiopharmacy p r o.

fied by the rtst to ratienta and t here tect the health and safety of the sides radiepharmaceuticals to other t olunt ary st a nda rds, or compilance pubtle. The patient is a member of the bonp! tats and practitioners in its area _

s tth these standarda, are inadequate. pubile, notalthstanding thf Commta. As noted in the proposed pchey ston's recognition of ph)sleikns' prima. statement, the NRC 3111 defer to theg 111. Disct'ssion or INatte CowutwTs ry responsib!1 tty for prot ection of Tood af.d Drug AdminiMration @Al

a. cowMuits om Tus couct traf twurf their patienta The rohey statement regarding a detertninat6on of those ac.

and. Indeed, a!! of t he Commissinn's thHies or nuticar pharmacies that sitt One commenter opposed the use of be considered manuf acture and those the geners!- terTo *radiolsotope4" tra actions in terulattr.g the medical uses of raJiotrotopes. arkr.c s tedge the sec. arthities that till be considered the the first part of the polley statement. ordinary practke of pharmac) t eorn.

Thts commenter s aa concerned that, ur.dary but necessary role of NRC in nMating the rad:stion safety of pt. poundirg and dapensingt If taken out of the content of the foot. Four commenters objected to NRCs note. It could be interpreted to include tients The Cornmiss' also corunders pa tientJ to be both and tecipl. beenstr.g nuclear pharmartes to de ria t urally occurrirs and accelerator ents of radioacthe F 1 Hos eser, tribute on!) those prodweta that ther pre,duced radiolsotopet base pretared from VDA approsed the distinction b*ts . . r ec etpt and The Cornmluton belleses that the radiopharmaceutkals or reagent kits-genertl term "radioisolcpes" is plain use of radscarthe materlats is not One conimenter etted the practice of fr ghah and emally recogntled by the rneutngful in this case because NRC regulates, among other things. receipt, nuclear pharmacies suppl 3tng radio, pubhe. It s as properly footnoted in the pobey statement to include the possession bse and transfer ef b> Trod, chemic als to researchers t he use uct. source and special nuclear matert, them on humans under their ee n more currberstme but specific tetyns; al in protnttr.g the health and safety A ns s biprottuct, source and special nucleas of a mcd ,, , n,4 rnalerial and to exclude r.aturally oo of the public. One commenter rioted that TDA per$

a cowwurts em startric isst*ts mit.a nuclear rtarmacles to oprate in d ca ie ate One enmmenter in opt.osition to There sere ala comrnenta on the g gh ,Y, o g'h a NRC's regulation of pattent radtation question of reporting mbadmtnistra- State and lon! pharmaceutical repu'a-safety, suggested that NRC lirait its tions of radmsettve tr.atertal. Three tions The tso other com?cnters role to the radiation safety of the hos- commenters opposed army mbadmin* characteraed the NHC s restr6ctions pital staff and the general patient tration reporting ud three corn- on the d.stribution of popuisttort He belleses that patient menters offered suggestions on hcw tadaopharmaceuttesis by nuclear phar.

dostmetry Es a responsiblilty of the tn' they should be reported All of the macies as an unm arranted intrusion dindual institution and not NRC. Thts comments s LIJ be con.stdered in dealing - into the practiet of pharmacy s htch is commentet feels that NRC should 3 tth NRC's nes ty proposed mbadtran- tegulated by the States.

first require agequate staf fing. includ' tstradon reporting reWrernent that NRC heernes nuclear pharmaetes to try a board certified ph)stelan or rs' s as pubitsbed in the Tntw.i Rtctstu dLatribute radioactne drugs that base en e t #I ## "#" " # * " ## *" *I * "d'8 er nd hen asenti FR 39294 rad."oartne drugs subject to an FDA-Institution alone regarding dostmetsy' There sere sta comments on the ape- approsed ~ Net Drug A pphrat ion" instrumentation, caJit ratfort drug pit >

ctfle issue of paramedical traintna. .INDA), or "Notste of Cla med Insestb turement or any other funetton cot" Three commenters bellege that it la gational Esemption for a Nes Drug" unneceuary for NRC to become tre slNDt NRC rehen on FDA arprosal of h a utr the e ts solved tn raramedical tralning because radioactne drugs treatae hRC has staff fla' c[cr'a' tion sith a radiation several organizattorts are already pro, not regulated the 4.afet) and effectne, siding or deseloptng minimuro stand Des.s of retoacthe drugs since 1975 n e a y ar e.e !! ed tra e Also, there are not man) States that ards. guidelines or certificatterL One administer radioacth'e material or rt. ccmrnenter bellend that NRC should are equipped to regulate ratoactne diation to pat!ents Hos tser, the Com. drug safet) and e ecta eness.

mtsston cannot Itmit it4 regulatory role be insoised in this area because the to protseting the hospital staff and tethnologtst not the physician, does Dated at Wa.shNton. D C. this 1st rnost of the sork sith radiotsstepes. day of Tebrary IMg.

the general patient population and at Ts 3 commenters belteve that radiolog.

the same time fulftti Ita congressionaj mandate to protect the heajth and Inf physteists should be separated out safety of the pubite as regard.s source, from other paramedtral personnel and byproduct and spacial nuclear matert. :r c of these commenters offered a al The patient being treated or dias, definition of radiolettral ph>stetst r

PS-Mtj 3 November 30,1988 e