ML19242A195
| ML19242A195 | |
| Person / Time | |
|---|---|
| Issue date: | 06/06/1979 |
| From: | Hendrie J NRC COMMISSION (OCM) |
| To: | Synar M HOUSE OF REP. |
| Shared Package | |
| ML19242A196 | List: |
| References | |
| NUDOCS 7907310564 | |
| Download: ML19242A195 (2) | |
Text
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.f y [ dj NUCLE AR REGULATORY COMMISSION UNITED STATES g *.g e
WASHWCTOR O.C. 20555 y
f June 6, 1979 OF FICE OF THE CHAIRMAN The Honorable Mike Synar United States House of Representatives Washington, D.C.
20510
Dear Congressman Synar:
This letter responds to your April 11, 1979 inquiry to Mr. Carlton Kantnerer, which included a letter from your constituent, Rodney D. Ice, Ph.D. regarding the impact of the Nuclear Regulatory Commission's (NRC) regulations on the practice of pharmacy.
We appreciate this opportunity to explain NRC's role in the regulation of nuclear pharmacies.
NRC has legislative authority to license and regulate all aspects of the possession and use of byproduct (i.e., reactor-produced) materials, including radiopharmaceuticals. in order to protect health and minimize danger to life or property.
The Food and Drug Administration (FDA) has legislative authority to regulate the manufacture, sale and distribution of drugs, including radiophamaceuticals, in order to provide reasonable assurance of safety and effectiveness.
In the case of radioactive drugs, both FDA and NRC have regulatory responsibilities.
In 1975 FDA terminated an existing exemption for those radiopharmaceu-ticals previously regulated by the Atomic Energy Commission (AEC).
At that time, AEC withdrew from regulation of the safety and effectiveness of radiophamaceuticals with respect to the patient in order to prevent dual regulation.
Since then, NRC medical licensees have been authorized to receive only FDA-approved radiopharmaceuticals.
In the context of this letter, the phrase "FDA-approved" refers to FDA's approval of a "New Drug Application" (NDA) or FDA's acceptance of a " Notice of Claimed Investigational Exemption for a New Drug" (IND).
NRC has issued licenses to nuclear phamacies authorizing them to provide FDA-approved radioactive drugs to NRC and Agreement State medical licensees.
Basically, NRC's regulations have very little effect on State control of the practice of pharmacy.
NRC will not license a nuclear pharmacy unless it has already been licensed by the State for the practice of phamacy.
It should be noted that the primary con-sideration of the State is whether pharmacy personnel have adequate training and experience to compound drugs.
The state generally does not consider the same issues as does NRC (i.e., radiation safety).
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The Honorable Mike Synar NRC will license a nuclear pharmacy to prepare and distribute only those radiopharmaceuticals tnat have been approved or accepted by FDA.
In most instances, the nuclear phamacy purchases FDA-approved radiopharma-ceuticals or FDA-approved radionuclide generators and reagent kits, and then prepares individual patient doses that are ready for injection or oral administration.
Less frequently, the nuclear pharmacy may obtain FDA-approval for its own preparations or it may prepare radiopharmaceuticals for individual physicians who have obtained FDA-approval for their own products.
FDA will approve a radiopharmaceutical for routine use (i.e., approve an NDA) if the sponsor meets quality control standards and the sponsor has demonstrated substantial evidence of safety and effectiveness of a radiopharmaceutical. When the safety and effectiveness of a radiopharma-ceutical have not been established, FDA will accept the radioactive drug for investigational use (i.e., accept an IND) if the sponsor has established certain criteria for safeguarding patients.
FDA approval of products distributed by nuclear phannacies has always been a condition of the phamacy's NRC license.
NRC has recently published a statement of general policy on the medical use of isotopes (copy enclosed) which is consistent with this regulatory approach to nuclear phannacies. The second part of the statement reads:
The NRC will regulate the radiation safat) or patients where justified by the risk to patients and where voluntary standards, er compliance with these standards, are inadequate.
In summary, we do not believe that NRC's regulation of the nuclear portion of a State-approved phannacy is too restrictive.
Nuclear pharmacies may distribute FDA-approved radioactive drugs.
We do not believe that it would be in the best interest of public health and safety to authorize nuclear pharmacies to distribute radioactive drugs that have not beer approved or accepted by FDA because FDA is the Federal agency responsible for drug safety and effectiveness.
I trust that I have answered your inquiry.
If you have further questions please contact me again or call Mr. Vandy L. Miller, Chief of the License Management Branch. Office of Nuclear Material Safety and Safeguards, at (301) 427-4232.
Si,ncerely,
(
s bU hd y
,typh M. Hendrie
Enclosure:
565250
82C EULIS AND REGULATIONS bpergljy orieDted toward assistin; 1759%01-M ]
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etfied phyncians :n cimenarsw p
g
""hu NRC polM Matf2eUS O their responsibilities to Pz lents. HoW*
gm.c gg; in:c. NRC MCeTJees other p.;er, rer;2ation by AEC/NRC has a:
CH APTER l-NUCtE AR REGULATCRY Tem-ra] anc Sl2Le agenCaes 130 IUe Cne time or another enCompas3e 0 COMM15:!CN 7.m.e of the Cc-mon s gene:M 9 nearly every aspect of the del!Very 0:
tenues recarc = tne rrgWauon o-rad:01sotope medical services to pa-the mecical uses of radioisotoon tients. The broadest regulation oc-PART 10--HUMAN USES CF It as exweted inat future NRC acut-g}*ed between 1962 and 1975, when BYPRCDUCT MATERIALS tues in the med: cal area. suc.*t a.s pro-Food and Drug M*ntetration mulgauon of new regulanons and de-Regulation of the Medical Utes of ul p=ent of cooperauve relauensh:ps (FDA) eTPmpted from its reQulTe-ts for new drugs EU Itadioisotopea Statement of Genee- $t$$t NogECocher ophamacMcals nguW e al PoGey Based on past expenence and the AEC. Durtng this pedod AE mgulat-AGENCY: Nuclear Regulatory Com-comments and adnce of the pubile, ed the radiation safety of workers and other Federal agencies, the States, and the general public and the safety and mission.
NRC"3 Adytsory Committee on the efficacy of rcdioactive drugs and de-AC'IION: Final Foucy S,,,,,,y Meal Uses f hpes. the Commn.
vices with respect to patients. AEC con has developed the following state-regulation included production of the SUMM AftY: The Nnelene Regulatory ment of general policy to guide its reg.
radioisotope manu.facture of the h Commee (NRC) has the followmg clanon of the medical uses of radioao. radiot.:tive drug product or device. dis-policy statement regard mg NRCs N'
tnbutton, use and disposal of the prod-future role in regutsfin the medical
- 1. The NRC win continue to regulate ucts. In 1975. the FDA terminated the uses of radioisotopes. Th2s NRC po1L"y the medical uses of radictsotopes as esempuon for racilopharmaceuucals.
statement is intended to inferm NRC emy to provide for the radisuon statmg that it woul:1 now regulate the licensees. other Federal and State safay of w rte.7 and the general safa y and efficacy of radioactive agencies and the public of the Com-W dn2gs rim respeen to panents. (As mitenn's general intsntian regardhg
- 2. The NRC will regulate the radl*
noted later in this statement. FDA the regulation of the medical uses of anon safety of patients where justified t:y the risk to patients and where vol-does not regulate the phymemes rou-radioisotopes. It is erpected that tine use of radiopharmaceuttente ) At future NRC activities in the medical.mtary standards, or compliance with these sund2rds, are inadequate.
the same time. NRC withdrew from regulating radioactive drug safety. and area. such as promulgation of new reg-
- 3. The NRC will mm% intrusion ulations and development of coopera-into medical judgments affectmg pa-efficacy. emnr thaz it would regulate the ruh+mn safe:y of the workers tive relationshipe with other Federal t:ents and into other areas traditional-and the public. T2:e 1976 Medical agwtet, w1U foDow this carewt of 17 considered to be a part of the prac-NRC poHey.
tre of medicine.
Device Amendments to the Food. Drug and r'n-tic Act extended FDA's au-ur t.a Am DATE: February 9.1979.
II. RAUoNAI.E thority over medical devices (including devtces centsinmg radioacuve materi-FOR rum um.a INFORMATION The NRC and its predecessor the als) in a way omiln' to its authority CONTACT:
Atnmie Energy Commitsinn have regu-over drugs.
Mr. Edward Podolak. Of' ice of lated the meest uses of radioisotopes NRC's authority to regulate domes-Stsnards Development. U.S. Nude. enre 1946. AEC recognized that physi-tically the medical uses of byproduct ar Regulatory
&w-*
Wash-cians have the primary responsibility material is found in the Atomic ington., D.C. 20555 (Phone: 301-442-M me protecucn of their patients Energy Act of 1954. as amended. For g
and Mrned its regulations according-emnle. section 81 of that Act autho-
- 17. The physicians were required to be rises NRC "to issue general or specific SUPPLEMENTAL INFORMATION: li:ensed by the State, and their appli-licenses to applicant.s seeking to use The NRC has developed the following cable training and experience were three part policy state =ent regarding eraluated in censultation with the Ad-byproduct, matenal for * *
- medical NRC s future role in regi. int'nt the fuory Committee on the Med! cal Uses therspy *
- t" Section 81 directs NRC medical uses of radioisotopes. On of isotopes. This regulation has been to regulate the manufacture, produc-tion, transfer, receipt in intersta*,e March 17.1978, the three part policy commerce. acquisition, ownership, pos-statement was published in the Fr:ra-
'sc licenses radiotsotopes in three cate.
session. import and export of byprod-Af. RzcIstax (43 FR 11:08) for public ranes: byproduct, source and specal nucie.
uct material. F'nallv. Section 81 also comment. Copies of the poucy state.
ar matenal. The nc does not reguiste oat-directs that:
ment were sent to all NRC medical 11-waW occurring w accelerate produced r>
censees, the States and 25 profetzinnal de The term Dyproduct mersnal Tbe ComWon sha.II not permit the dis.
societies. Federal s. gem 1et and ind!- zoesns azy r=maart.tve material (except spe.
tribution of any byproduct matertal to any casa nuclear mar >rtan rielded in or raade r heensee. and mhan recall or order the recan viduals. The comment period expired me,e by exposure to the r=+=non ines.
of any dmbuted enertal from any 11cene May 16.1978. Twenty-two enmme ts dent to tne process of producing or u+'h-'n, ee wno is cat equipped to observe or fans to were received. Nine co'-" er***s fa, spasst anM*u misrial. The term soure, observe such sa.fety staccards to protect vored aU three parts of the pollCy meiersdJ m**Pa (1) uranicm. thortum or any healtri as may be established by the Com-statement. four co""-'t*Ps opposed thereof. in any physical or cussion or who uses such material in viola.
cr-w-.,. mm one part of the policy **"-" and ct.ement form or (2) cres which contain by
- t. ton of law or regulauon cf the ComrMmon re4tt one-twentieth of one percent (c.05")
or m a manner other t.han as emed in nine commenters addressed specific or more of (1) uranrum. (11) thonum or (111) the appucauon therefor or approved by the issues discussed in the Ma.rch 17. 1978 an7 e=a"e thereof. Source mater:a ccm m eon.
P DrRAL Rmtstra notic* The com.
co s not incluce special nuclear matenaL Commission regulations. for the ments are d:scussed in Section II.
Deese nacicagauencl means (1) plutorJ.
most part set fcrth in 10 CFR Part:; 3n Ccptes of the co==ents =2y be exa=.
Q"] Q p.g ge]3e
. througn 35. were prcmulgr.ted to carn ened e
med m the NR-Puche Documen' Recm at 1717 E Street. N.W. Wash-mz:er.a sr.tn=any ennenec er any cf tn, out the broad re:uistory seneme en.
!c.eso:.ns. but coes not incluce scuree =4te.
vtsaged by secracn 21. For exn.tnp.'e.
ington. D.C.
naL Pr. 35 estahanes regulations spec:Ile FILE 1At t!:::TE2, VOt. p. NO. 29 4tt0AY, nts'. ARY 9.19r9 abn, r7c c
w hh a
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us-m i w e n-
RULES AND REGULATIONS 8243 to human uses of byproduct material The NAS-BFIR 8 report dismes The regulations try to find a balance FDNs statutcry authority (Federal limiting the exposure of t!'e popula-between adequate controis and avoid.
Food. Drug and Costnetic Act, as tion to.nedical appucadons c: icmmns ance of undue interference in medical awnded. "I t'.S.C. ::01 et seq.) does radia:!on. That report. Th:ch i :cludes jud;rnants. A censequence of too r.ct d:mmish JRC's authority. Where all medical uses of ton::ing racuton, much regulation could be poorer NRC's and FDA's authenties overlap, shows an aver ge dcse ra'.e fr:m health care deilvery to patients. A con-the respecure authortues can be har.
r.nzicphoneuccais of 1 mrem / year sequence of leaving to physic:3:.s the mOnced by interagenC" agreement.
and an &Verage dose rate from Cir.g-majon!y of the dections conce*=.ng The centml que:non is a que:non of ncsuc racioicgy ot.. c rem / year la g,,7 pggen,
,3 g.
g, postcy not cut.hort:y. n2=ely:
MO To what extent should the protee.
,Th'e fonoring quotrion is from the TH1 ~ ale mistates. "~he tightest ladon of physicians decisions by tion
.. AS-EL R repart.
JRC,of the patient be considered m
.d S W W W m M p m M s regulauon of the Ined: cal use of In tne foreseeable future, the major con.
not be able to prevent iuture incidents byproduct matertal?
tabutors :s radiauon exposure of the popu-in the medical uses of radioisotopes.
Prom the standpoint of cu.,hort y..,. Lauen wu! conunue to be nat ral baca-The ~ Commf *nn recognizes that is clear that NRC can regulate the round with an average wboie body dose of medical uses of byproduct matertal to about 100 mrem / year, and med: cal acclic> DA rer".lates the manufacture and protect the health and safety of users cons wtuch now con.ribu:e comparaste ex.
interstate distribution of drt.gs. Includ-of this mn rectal, for instance, patient.s. posures to various tisst.es of the body. Meds-ing those that are radioacuve. FDA In licensing the possession and use of cai exasures an not under control or read-also regulates the investigational and byproduct material. NRC estab!!shes ance by nrMn or law at pnsent. m rmewch mes of dmss as well as the limits within which phy:1cians exer-use of ine r ndiauon in medicine is of specific guidance on doses and proce-etse professional discretion. From the $2d ""
"* [ h *d '*w*:C" i dures found in the product hh-h standpoint of polie/. these limit 3 plished without loss of benent and as rela-N b'8
- DAM N **
depend upon how NRC views the po-uvely low cost. The aim is not only to thority to restrict the routine use of tential hazard to the patient's health reduce the r=~ian expost.re to the inds. drugs to procedures Membed in the and safety in the uses of the byprod. noual but also to have procedures earned product labeling) DA has approved uct matenal. The greater the potential out with maximum eff.ciency so that there as raft and effective. Indeed IG.C is hazard to a patient from the byprod. can be a conunu=a increase in mehl the only Federal Agency that is cur-uct material or its use by a physician, y*n up"o"su"n."*"-c by a --+ " ndb rently au*horized to regulate t.he rou-E8 a
the more NRC may elect to circum, tine use af radioacuve cirugs from t.he sertbe areas that might otherwise be NRC will act to help ensure that rs-standpoint of reducmg unnecessary rz.
regarded as within the discretion of diation exposure to patents is as low diation exposure to e="-m" the physician.
as is reasonably achievable, consistent The Co - W = believes that the The first part of NRC's policy state-with competent medical care and with dbrvwtic use of radioactive drugs is, ment inMW" that NRC will continue mint-d intrusion into medical judg* in most cases, cicarly an area of low to regulate the medical uses of radiol-ments. NRC will not exercise reguia-rsdation risk to parla-" Thmfore, sotopes as necessary to provide for the tory control in those areas wnere.
NRC wdl not' control ptyrt.ctan's pre-radiacon safety of workers and the upon careful e--***n.
it deter-rogatives on panent semon. Insuu-genemi pub 11c.8 This is tne t aditional mmes that there are adequate regula-ment selecuon. 'she alma regulatory function of NRC for all tions by other Federal or State agen-uses of byproduct, source and special Cies or well ad"*tered professional drug selection and dose level for most nuclear material. It ts a regtuatory s~ m ovds. Wherever pnWe NRC QEnosce uses of masotopes. N all therapace uses M radioacdve role that was not questioned by any of will work closely with Federal-and the commentrrs but, rather. it was State agencies and professional g-oups drugs, and in certam r**1mmtic uses-conststently recognized as a neceuary in designing new voluntary guidance for nn-nie, the use of thosphorus-3*.
role in the medical uses of radioiso. for pracutioners to 11=i: unneceuary for 1r * *
- m of eye tumors--the topes.
Patient radh? ion exposure.
- sk to patienta is not law. The nst of NRC's regulation of the radiation The thi.d part cf NRC's po!!cy stnte. t:ssue or organ %ee (or even death) safety of worters and the general ment ind W " that NRC r.11 nuni. :s inherent in the use of therapeune puslic in the medical uses of radioiso.
m=e its incusicn into me<tical judg-levels of radioacdve crucs. NRC will
- cces is relin::'.ushed by NRC to Agree. =ents affecting the patent and into continue to restr2c the 1:ses of thers-
=ent States; coes not overlap r.th other areas traditenally considered to peut:c and certain diagnostic radicac-FDA's act'.V: ties" is in harmony with be a part of the pract:Ce of m201:58.
nye dn gs to the indicateri Orocedures
- gulatAon bi the Department of The Commission recogn=es that phy-that have been approve <i by FDA The Transportation. Social Secunty Ad.
siclins have the prt=a:7 recconsibility NRC will not control the :hynt--W nun:stration and the Joint Conu=
for the protection of their patients. prerogauves on We,c selection and non on Accrecit:. tion of Hospital:: anc The Comm'uion belleres that basic instntment selection for therapy pro-coveta:1s with Occupational Cafety dec::lons concerning the %<m3 and cedures. because these tirocedures are and Health > ** tration regulation cestment of dsease an a ca.t of c:e so sper-Wed and patent sper%-
of the Tort-place for t.he use of natu. Physici1D-pauent Mlanonsip and aM Congress recently gave FDA attrMnri-ra'ly-occurnns and accelerator p o-traditionally considered to be a part of duced radioacuve materiais, the pre of meoicne. NRC regula-ty to regulaa medcal deh Mu The second part of NRC"3 policy uods am pnd:sted on the ass.=npuon to FDA's authority to regclate drugs.
but with-additional authority to re-a ed a.
a ua statement indcates that NRC will reg-pr[o g,
p d - snict the rouune use of medical de-ulate the r"d *nn safe.ty of patients where justified by the nsk to patients y,,,,,, y my, n=es as may be nece
_ry to proylee g
reasonable assurance M their safety and where voluntary standards, or and effectntness. FDA has not yet ce=pliance with these standards, are had suffWent time to irnplement it.s madequate. As noted before. NRC has
'Nauocal Acade=ir of scences Acar7 full authonty to regulate medical de-
- he authority to ref.: late the radia*1on Committee on the B10!crical E.!!ecu of Ico-vices con *P"*7 byproduc* source or safety of pat!Cnts.
D EI N O
MM E
E!:ecu en Pom cuns or Z:cosure to Low -OeOsl nuOles*- J eri d * - -- - Cre-Lc:cu of Ionwng Red:as:39..Vanns2 NRC W.'.1 continue to restnet physi.
"I'he te--. rece-al putile m this sa:e-assemy" of See.res-Ne.o-:c1 Reacard c:an's uses of these me<*'-C dev ces.
- .ent s::ec E ehuces pane.:s.
C01.nc:t Washmston. D.C. (13 h both for diagnos'3 ind therapy. to FICER.At IfCit TL VCt. 44, NO. NI: PAY, F!!tt:ARY 9.1979 M_
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_A d N !=N Y
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8244
. RULES AND REGULATIONS tncsc procecuras in.t.'mC ha.s deter-
"'wo ec= ente s objected to NRC's
.O noted in the proposed pcher nunec un eensu uct uth : s Acvtso-rr.uaten of patent r2Wanen saf et statement NRC is studymc the var rv Cc
. tee en the ?.ier.c:J I;ses of b-cause they believe that NRC coes :ous alhed health ceruficat;on pro-Isotopes) to be :af e anc effect;ve-not have the authority to regulate ;a-gra ms currently in effect or beln; The Con -on coes not censider uent safety. They note that NRC's en-drafted by other Federal. Str.te and equipment ca. c nuen. cushficauons abimg leg:siat:cn coes not specifica"y p-of essional groups. If the coverage of paramecaca; personnel cr reportmg mennon the radiauon safety of pa-pronced by these programs is not ade-to NRC ~*mustrataons of rad:cac-tients. They beheve that patient quite to protect the patent from un-tive ma*.enal to be exch:s.17ely the safety is the responsibihty of the phy-necessary radisuon exposure. NRC practice of medeme or a part of phys 1 sacan, a responsibility that cannot be Wul work with these groups to develop can patient relatunslups. The Com-shared They believe that the Co==1s.
a new NRC proposed rule for the mean mtends to regulare these a.res.:
sion is in error to equate patients with tral ing of allied health personnel.
of patient radiation safety where just1* the public and to consider patients as
""here were five comments on the fled by the rtst to pahemt and where users rather than recptents of radio. sp(cfic subject of nuclear pharmac 2es Voluntary da nd a rc.s. or Comphance act3ve m2ferial.
(radiopharmacies).
With these c2Wis. are MM*quate.
As noted in the analysis of the simi.
One commenter urged NRC to dis-lar comment above, the NRC's overnd. tinguish between radiopharmacists III. Discusstos or Pt suc Couur:rrs working in a hospital setting and those ing congIminnal mandate is to pro-TCrMg in a retad Emonment (cC43-A ccM3mTs os mz roucT staTWT tect the hegith ggd gg{ety o{ the
~ ercal nuclear pharmacy). This com One commenter cpposed the use of public. The patient is a me:nber of the
.. enter also noted the complexity o the general ie m " radio:sotopes" in public, notwithstaning the Co-~"-
fospitalWem of deme een }r.%
l the f:rst part cf the policy statement. ston's recognitten of physicians
- pnma, based radiopharmacy e
othe;.
g This commenter was concerned that. ry mponsibuity for protection of o
ndes radi,p armaceuticals to l
if taken out cf the centext of the foot, the:r patients. The policy statement hospitals and practiuoners in its area.
l note. It could be Interpreted to include and indeed. all of the Co mon's As : ted m the proposed polic) naturaHy occurr= g and neceWator. acnons in regulattng the :ned: cal uses statement. the JRC will defer to the produced radioisotopes, of radioisotopes, acknowledge the see-Food and Drug M-ir stration (FDA)
- he Commion believes that the ondary but necessary role of NRC In regarthng a deternmation of those ac-general term ~ radioisotopes" is pla.tn re#2rint the radiation safety of pa-tin-Jes f melear phanraczes that wul Engtsh and euny recogn=ed by the tients. The Ccm mion also considers be considered manufacture and those puclic It was property footnoted in patients to be both users and recipi-actinties that will be considered the the poucy sinte=ent to telude the ents of radioactive matertal However, or na.7 pracke of p;my (com-mere cumberseme but specific tem the distinction between receipt and pcunding and dhpensing).
Dyproduct. source and specal nitMene use of radioactive materials is net Four co=:nenten objected W NRCs matertal and to exclude naturdly oc-meaningful in this case because NRC heensing uclear Dhacles to dis-currt;.g and accelerator produced ra-reg
- f x accng other thmgs. rece:pt. tricute only those ploducts that ther dioactive mater.11.
pm**on, use and transfer of byprod-armaceutfrom FDA-approved prepared have One commenter. in opposition to net, source a:id special nuclear materi-eds er reageI2t Ms.
p NRC's regulanon of padent renMnn al in protecting the health and safety One enrienter cited the pracuce of I
safety, suggested that NRC li= t its of the public.
nuclear phar-me'es supplytng radio-role to the restan safety of the.hos-pital staff and the general patient 3 Cc"'rtTS 0:s srtctric tsst.Is chemicals to researchers who use them on bnmm under their own population He belleres that patient ere e six c unents on the FDA " Notice of Claimed Investigation-dos: metry is a responsibility of the in-C 88 3 f T'P "i 8 '""
r3-11 Dte=ption for a New Drug" (INDL dindual institution and not NRC. This tt ns of rmi active materia Three One commenter noted that FDA per-ec- *mter feMs that NRC should c =nienten pp sed any mw-%
- nns nuclear charmac:es to operate in first require adequate sM'ig. incluo.
ation reporung and three ecm-the absence of a final determination of tg a board ce-tified phys:cian or ra-men en offered suggesdons on how their status, providing they :neet all d:ccha.macist and a re sticn safety they should be reported All of the State and local pharmaceuucal regula-officer, and then essentially leave the cc=ments WUI be considered'in dealing t!cns. The two other commenters insutution alone regarding desi=etry, with NRC's newly proposed "k'%-
cha.racten:ed the NRC"s restrictions instrumenen cahbration. dn:g pro-1suadon reporting require =2ent that on the distnbution of curement or any other function con-was published in the FmERA:. REctsTIR radiopharmaceuticals Dy nuclear phar.
sidered to be the practice of me+' e-for public comment on July 7.1978 (43 mac:es as an unwarranted intrusion NRC does require the licensee to FR 29297L into the practice of pharmacy which is staff its operation with a raiation There were six comments on the spe-regulated by the States.
safety officer and a phyes" tnot nemrtly board certified) trained to cific issue of para =edical training.
NRC licenses nuclear pharmacies to m5imster radioactive matertal or ra-Three en-menters believe that it is distribute radioactive drugs that have diation to patents. However, the Com-ttnnecey for NRC to become in.
been approved by FDA This includes miss2cn e2990 h=1t ns regulato.y role volved in paramedical trM9tne because radioacuve drugs subject to an FDA-to protecting the hcspital staff and several orgar"-stions are already ; o-approved "New Drug Applicauon" the general padent pcpulation and at riding or developing mmtmum stand.
(NDA), or " Notice of Claimed Invesu-the same tune fulfill its ecmonal artis. guidelines or certificat2cn. One gational Exempuon for a New Drug" mx.ncate to ; otect the health and cc=menter believed that NRC should (INDL NRC relies on FDA approvn1 cf safety of the public as regartis source, be involved in this area because the raicactive drugs because NRC has baroduct and special nuclear =ateri-technoleg:st. not the physician. does not regulated the safety and effective-1L The patient be=g treated or diag-most of the werk with radictsoto;es, ness cf radioacuve drugs since 1975.
nosed wun.u cacuve =aterul, a:
"'wo ecm= ente s believe that radicic;.
Also, the e are not many States that 1
an empe 1 to Mpume raicacm ica. phys:c:sts should be seca. rated cut we.1 as the geners.; pubbe wno =sy be excesed to rac.at.cn as : raruit cf that irc= other para =ec:cC :erscnne; and eng sale'y and eff ecueneca.
treatment. are a.J mem s cf the one of these ec== enters c!!ere.
Date-i at "le-htngton, D.C. tius in public tc be p-ctectec by NRC.
dWtion of radiolog: cal phys:cist.
day of February 1973.
FIp1RAL ttCtSTER VCL 44. W. 29-FR!a AY. FEttJARY 9, j
mn W8 wm
NOTICES (7590-01-M]
ered for future vacancies as they de-Fct the Nuciaar Regulatoc tJ.-
velop. Nom!nntions should be sent to mis.sien.
NUCLEAR REGULATORY the S.e.m J. Cmix COMMIS$1CN Secrete-/ c/!he Co Im133tt SeC*tary of the Commission. N1*IN: Adv1 WR Ooc. 79-4 H 3 *Ned 13 4 5 ADVISORY COMMITTII ON THE MIDICAt sc.y Cc==1ttee Management. Ofncer. Nu-c.-ar Regulatory Commuston, Wa.shng.
Usts or I$oforts
- t. :
D.C. te555.
Nomh N Nw Moniem Dated at Washington, D.C. thig 7th The Nuclear Regulatory Committion day of February 19 f 9.
(NRC) is anticipating three vacancies For the Nuclesr Regulatory Com-on its Advisory Committee on the meenn.
Medical Uses of Isotopes ( ACMUD and Joint C. IIons.
is inviting nominations from members of the medical community and from 4detsory Commttfee Mancoement OBicer.
other interested groups or individuals.
The purpose and Iunction of the CFR Doc. 79-4590 FDed 2-t2-79; 8;65 sml ACMUI is to advise the NRC staff on problems or questions that arise in 11-ceming the use of radioactive material for httm an diagnosis and therapy.
Duties and responsibilities include evaluating the trufning and experience requirements for phystef am who re-quest authonzation to use radioactive materials for medical purposes; provid-ing guidance and comments concern.
ing changes in NRC rules, regulations and guides concerning medical uses; and evaluating certain nonroutine uses of radioactive materials for httman di-agnosis and therapy. Additional de-talls regsrding the duties and func-tiens of the committee and its mem-bers can be obtained by telephoning Mrs. Patrtcla C. Vacca at (301) 427-4232.
The eight member ACMUI consists of two pnysician specialists b Thera-peutic Radiology. one physician a spe-cialist in Nuclear Medicine Mth a br.ckground in Pathology. two physi-c:an speciahsts in Nuclear Medicine with a background in Radiology, two physician specialists in Nuclear Medl-eine with a background in Internal i!edicine, and a specialist in Medical N1ysis. It is intendec that this bal-ance of med! cal specialists re=ain con-stant.
In Accordance with established pro-cedures, the three committee members
- 1th the greatest length of service will be retired. creating vacancies for two spw.211sts in Nuclear Medicme who have backgrounds in Radiology and specialist in Nuclear Medicine who has a background in Internal Medicme.
Nominations must include a resume describing the educational and profes-sional qmif fir-Mions of the nominee and his or her current address. Candi-dates must be U S. citizens and be able to devote approximately 150 hours0.00174 days <br />0.0417 hours <br />2.480159e-4 weeks <br />5.7075e-5 months <br /> per year to committee business.
All quallfled nominees will receive fu'.1 consideration. Appointments are
!ct four year terms. Compensation for Senices of the members is provided in hecordance with government policies.
Nominations received by March 15.
1979 Mll be consicered for the forth-commg vacancies. Nommations re-Mned after that date will be consid-FEDERAL IIGl37tt. VCt. 44, NO. 31-TUE$oAY, Fla.eUARY 13. IM
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