ML20149L933

Provides ACMUI Comments on Strategic Assessment & Direction Setting Issues Papers for Submission to Commission Prior to End of Comment Period on 961202

ML20149L933
Person / Time
Issue date:	11/26/1996
From:	Stitt J NRC ADVISORY COMMITTEE ON MEDICAL USES OF ISOTOPES (ACMUI)
To:	Cool D NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS)
Shared Package
ML20149L936	List: ML20149L933 ML20149L955
References
DSI-7-00040, DSI-7-40, NACMUI, NUDOCS 9612100041
Download: ML20149L933 (8)

Text

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pq t UNITED STATES

! 2 i i! NUCLEAR REGULATORY COMMISSION I f WASHINGTON, D.C. 20555 4 001

,/ November 26, 1996  :

HEMORANDUM T0: Donald A. Cool. Director Division of Industrial and

• l Medical Nuclear Safety. NMSS l FROM: Judith Anne Stitt. M.D., Chairmqnq 1 l

Advisory Committee on the Medicalf

! Uses of Isotopes  ;

r

SUBJECT:

COMMENTS ON STRATEGIC ASSESSMENT AND DIRECTION SETTING ISSUES PAPERS  ;

i 1 am providing the ACMUI's comments on the Strategic Assessment (SA) and discussion of the Direction Setting Issues (DSI) papers for submission to the  !

i Commission prior to the end of the comment period on December 2,1996.

Detailed minutes of the entire meeting will be forwarded at a later date. The i Advisory Committee on the Medical Uses of Isotopes (ACMUI) met on November 14-15, 1996. Strategic Assessment and discussion of the DSI papers  :

were a major topic of discussion during the meeting. The ACMUI deliberated on l a number of thoughts and ideas on the SA process, many of which will be detailed in the minutes. I am summarizing the main issues and the consensus l-  !

items as a result of the committee's discussions. j The ACMUI had extreme difficulty in understanding DSI #12, Risk-Informed, <

Performance-Based Regulation. The paper is difficult to comprehend and l members were concerned that members of the public would have difficulty f understanding the issues, thereby minimizing the number of comments the Commission might receive on the risk paper.

The ACMUI agrees that risk should be used as a factor in establishing l regulations. Members expressed concern as to who will determine risk in using a risk assessment approach to the development of regulations. Additionally, in discussing risk. it is unclear if it is risk in terms of occupational worker risk or public safety risk, and how this relates to considering a  :

patient as a member of the public, as discussed in the 1979 Medical Policy Statement. Assessment of medical risk versus benefit is the practice of medicine, rather than a regulatory decision.  ;

r The ACMUI discussed the options outlined in DSI #7, " Material / Medical l Oversight " and were concerned that it appeared that ACMUI's recommendations resulting from its February 21-22, 1996 meeting were not considered by the Commission. The members indicated that they do not have the confidence, and they do not believe the regulated community has the confidence, that the NRC,

, even with SA can make the necessary changes to effectively regulate the use of byproduct material in medicine. The Quality Management rule was cited as an example, in that a performance-based rule has become very prescriptive.

After deliberation. the committee voted, by consensus, that the recommendations made during the February 1996 meeting are still the ACMUI's l

t first choices for the direction in which the NRC should proceed. However, the 9(p(EllNM

. l i

ACMUI' Comments 2 7 ACMUI did agree to amend the initial recommendation, that the Department of i' Health and Human Services should be the Federal agency for regulatory oversight, to state that a new or existing Federal agency for oversight needs '

to be an agency with a medical or health focus rather than a regulatory focus.

i

, These recommendations ara included in Attachment 1.

l However, given that these recommendations were not included within the .

l preliminary views of the Commissioners, the ACMUI focused on the options given l in DSI #7. especially low-risk versus high-risk activities. Time did not  :

permit the ACMUI _to develop a clear consensus as to what would constitute low-  :

or high-risk activities.

As part of its discussion of DSI #7 the ACMUI focused on the 1979 Medical Policy Statement (MPS) (44 FR 8242) (Attachment 2). There was considerable  ;

deliberation that when the Commission adopted the policy that medical patients j are considered a member of the public. NRC began to interfere with medical.

i

! practice. There is a conflict when the policy says that NRC will not practice medicine. but patients are considered a member of the public. Statement 2 of l l

the MPS states that. "The NRC will regulate the radiation safety of patients where justified by the risk to patients and where voluntary standards, or  !

compliance with these standards are inadequate. Many members indicated that, based on this statement, there are many regulations for W .h the  :

justification based on risk does not exist, such as misadministrations of l l diagnostic uses and the recuirement for. ALARA. While the events that prompted  ;

the MPS had to be addressec. there was some discussion as to whether NRC has i gone beyond the bounds of the MPS by broadening its scope to include l l regulation that was not based sufficiently on risk. 1 The ACMUI discussed the need to revise the MPS. such as including the term  :

"high" risk in Statement 2 of the MPS. There was much contro/ersy over this.

and how to define "high" and whether this is the direction to go. One has to consider the benefit to the patient in addition to any risk to the patient. i There was discussion that the public needs to be better informed as to the risks of radiation.

Subsequently, the ACMUI made the following motion: "The ACMUI recommends that l

NRC revise its Medical Policy Statement to include in statement number two the word "high" before " risk." Statement #2 would then read: The NRC will regulate the radiation safety of patients where justified by the high risk to patients and where voluntary standards, or compliance with these standards.

are inadequate.

This was approved by a vote of 6 in favor to 3 opposed. One individual voting against the motion believed it was more important to indicate exclusion of low risks as regulation of high risk activities is a given. One individual believes that revising the statement to include "high" is an over  !

sim)lification of the problem. It is not differentiating the risk associated i wit 1 things that take place as a part of the procedure separately from the ,

i medical procedure itself. One individual did not like using the term "high" l in the statement.

l

i -

• 1

ACMUI Comments 3 The ACMUI made the following amendment to the motion

"The ACMUI believes i that the 1979 Medical Policy Statement should be reconsidered; and the scientific basis of the statement needs to be reviewed with consideration of current research and studies: and the ACMUI is committed to working with the staff and Commissioners to provide guidelines for determination of procedures  ;

and activities that range from low risk to high risk to patients. Therefore.

the ACMUI recommends that the 1979 Medical Policy Statement be revised. This was approved by a vote of 6 in favor to 3 o) posed. Again, those opposed i believed that classifying activities by hig1 risk is an oversimplification of the problem. One individual voted against the amendment due to procedural reasons. He believed the original motion should have been withdrawn: that the amendment was a way to make the motion on the floor " fit" the current discussion.

Attachments: 1. ACMUI Recommendations 2/21-22/96

2. 1979 MPS l

l l

l 1

l I

RECOMMENDATIONS OF ACMUI The ACMUI reached a consensus as a result of committee deliberations concerning the following actions that should be part of regulatory reform:

. Rebuild the medical use regulatory program, without using the current regulatory program as a starting point. The objectives of the regulations must be reassessed:

. Federally mandate that the states administer the medical regulatory use program. with appropriate incentives to ancourage states to comply:

. State programs should be monitored by a Federal agency. The Federal agency should be an agency with an overall medical use perspective.

. Encompass all uses of ionizing radiation in medicine. not just byproduct material and not just radioactive material); and

. Conduct the medical use regulatory program in a uniform setting, whether it is conducted by a Federal agency or by the states.

l l

l

. l ATTACHMENT 1

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4 ATTACHMENT 2

g242 RULIS AND REGULATIONS 17590-01-M] I. MAmm or Go M!n gennaMy r n ed t uar amsue cuallfled physicians tn d:schstrng N' "*

• te ded to i or 1 ce ces ther their resports:bilities to pat:ents. Hor-Federal and State agencies and the M. MEulam by E E us at CHAPTER l-NUCLEAR REGULATORY pubtle of the Commission's general in. one time or another encompuse:1 COMMS$10N tention regarding the regu!stion of nearly every aspect of the delnery of the medict! uses of radioisotopes. radiouiotope medical servlees to ps.

PART 10-NUMAN U$ES OF It is expected that future NRC activ. tients. The broadest terutation oc.

itles in the medleal area. such as pro. curred between 1962 and 1975. a ter.

OM MRM mu! ration of new regulations and de. the Food and Drug Admimstrauen velopment of cooperative relationships (FDA) exeruptee from its require-4 Regwfotion of the Medical Uses of sith other Federal agencies. will ments for new drugs au Rodioisotopes: 5tatement of Ge9er* follow this statement of NRC polley. radlopharmaceuticals rerulated ty el policy Based on past experience and the AEC. During this period AEC reru:sd comments and adytce of the public. ed the radiation safety of sorkers and AOENCT: Nuclear Regulatory Com- other Federal aseneles. the States, and the general pubtle end the safety and inission. NRC's Advisory Committee on the efficacy of radioactive d. rugs a.nd de.

ACTION: Final Folley Statement.

Ma ileal Uses of Isotopes, the Commts. vices sith respect to patients. AEC cP. has developed the following state- regu.!ation included production of tne

SUMMARY

The Nuclear Regulatory en.nt of geners] polley to relde its ryg- radlotsotope, manufacture of the fast Commission (NRC) has the fouosing ulation cahe mecicAl uses of radictso- radioactive drug product or dence, dn polley staternent regarding NRCs topes:' tributton. ttse and disposal of the prod.

- future role in regulating the medical Jk 1. The NRC sill continue to regulate uct.s. I 1975. the FDA terminated the uses of radotsotopes. This NRC policy the medical uses of radiotsotopes as exemptlen for radiopharmaceuticCs.

statement is intended to inform NRC necessary to provide for the radiation stating that it sould now regulate tiie Iteensees. other Federal and State safety of workers and the general safety and efficacy of ra6cacta e ,

pubil agencies and the pub!!c of the Com. ge NRC t,ill regulate the radt- drugs with respect te patients. ( As noted later in this statement. TDA mission's general int 4ntion regarding#' tio'n" safety of pattents there justified does not regulate the physician's rou.

' the regulation ofItthe radiotsotopes- tsmed! cal uses expected thatof by the risk to patients and shere vol* tine use of radiopharmaceuticaLU At untary standards, or compliance with the same time. NRC withdrew from future NRC aethities in the meical these standards are inadequate, area. such as prcmulgaticn of new reg.

• 3. The NRC will minim.!r.e intrusion regulating radioacthe drug safety and ulations and development of cocpera. Into medical judgments affecting pa* efficacy stattng that it sould regula'e tive relationships sith other Federal tients and into other areas traditional. the radiation safety of the sorkers and the public. The 1976 Medical

, agencies, NRC poucy, will follow this staternent of ly considered to be a part of the prac. Device Amendments to the Food. Drug i tice of medicine. and Cosmetic Act eatended FDA's aw l EFFECTIVE DATE: February 9,1979. II. R AT!CM Alg thority over medical devices itne:ue.ng devices containing radioacthe matert.

FOR FURTHER INFORMATION The NRC and its predecessor tne als) In a way similar to its authcrity CONTACT. Atomic Energy Commission have regu* over drugs.

M r. Edward Podolsk. Office of lated the medical uses of radictsotopes NRC's authority to regulate domes.

Standards Development. U.S. Nucle. sinc

• 1946. AEC recornized that physt- t!cally the medical uses of byproduct at Regulatory Commission. Ws.sh. clans have the primary responsibility material is found in the Atomic ington. D.C. 20555 (Phone: 301443 for the protection of their patients Energy Act of 1954, as amende1 For 5650)* and destgTied its regulations accorc'ing- example section 81 of that Act autho-ly.The physicians were requtred to be rtzes NRC "to tssue general or spect!!c SUPPLEMENTAL INFORMATION: !!cer. sed by the State, and their appil. leenses to applicants seeking to use The NRC has developed the follosing cable training and experience were byproduct material for * *

• med;eal three part polley statement rerarding evaluated in consultation with the Ad* therapy * * '." Section 81 directs NRC NRC's future role in regulating the visory Committee on the Medical Uses to rerutate the manufacture. produe.

medical uses of radioisotopes. On of Isotopes. Thts regulation has been tion. transfer. receipt in interstate March 17,19'en. the three part polley cornmerce, acquisition, ouTiership, pos. -

statement was pubitshed in the Frun. 'NRC lleeraes radjolsotopes in three este. session, import and export of byprod.

AL Rectstr.a (43 FR 11208) for public sortes typroduct. acurce sad special nucle- uct material. F!nally. Section 81 also comment. Copies of the polley state, at matertal. The NRC does not regulate cat. directs that:

ment sere sent to all NRC medical 11 urally occurring or accelerster produced ra.

"The Commtaslon shd! not permit the dis.

censees. the States and 25 professional diotsotopea. The term byproduct malertal tributton of any typroduct rnstenst to any societies. Federal agencies and indt. means any radioactive matertal uncept sp,.

etaJ nuclear matertall yielded in or made rs. itewee. and shall recall or order the reea:

viduals. The comment period expired dioactive er exposure to the radiation tact. of any dastnbuted material from any licens.

May 16.1978. Twenty two comments eeot to the process of producing or utt1:stris ". S ho ts not egutoped to observe or f ads to sete received. Nine commenters fa. 'special cucJear matertal The term source obserse such safety standards to protect tateme t. I ur omme ters op o m u he a o e o n *h ' W 5C 8 y

gt , 3 t,, , 3, ,

one part of the polley statement and weight one-twentieth of one percent t0 058* , or in a rnanner other than as d4 closed in nine commenters adoressed specific or more of (1) uranium. till thortum or title the appitention therefor or sporoved by the ,

issues discussed m the March 17,1978 any combination thereof. Source matenal C'm'n158'*n- '

FrutRAL Rterstta notice. The com. does not incJude spectaJ nuclear osatertal. Commission regulations. for the ments are discussed in Section 11. Special nuclest matertal rneans til plutoni. most part set forth in 10 CFR Parts 30 Ccoles of the cornments may be exam. un urantum 333. ursalum enrtened in the ined in the NRC Public Document *

[,*t,E.g",Ng'ief,3f,M '

Yr$cYd tyer y ct outtf,the through 35. were promulgated broad regulatory scheme en. to carry er Room at 1711 H Street. N.W.. Wash. foretotng, but does riot include source rnate. visaged by section 81. For examn:c.

Ington D.C. ria.t. Part 35 establishes regulations specific f f Dtt at flGlifft. VOL ad, Dec. yt.Jalcay, rit UARY e.1979 l

l 1

Y RULES AND REGULATIONS 8243 to human uses of byproduct material. The NAS-BETR ' report discusses The regulations try to find a talance IT)A's statutory authority (Federal !!miting th'e exposure of the popula- betseen adequate controls and asoid.

Food. Drug and Cosmetic Act, as tion to medjetl applications of ioninng ante of undue interference in med: cal amended. 21 U.S.C. 301 et secJ does radiadon. That report. s hich includes judgments. A consequence of too not diminish NRC's authority. Where all medleal uses of loni:;ing ridation, much regulation could be poorer NRC's and FDCs authorf tles overlap, shoss an average dose rate from health care delivery to patients. A con.

the respective authorities can be har. radiopharmaceuticals of 1 mrem /yeu sequence of leaving to physleians the monl:ed by interagency agreement. and an average dose rate from d;ag.

majority of the dectstons concerning The centrs! question is a question of nostic radjology of 72 mrem / year in their patients is thai the physicians policy not cutAortly, namely: 1970.

To t hat eatent should the protee. The follos.ing quotation is from the will make ml. stakes. The tightest regu-latlon of physicians' deci.sions by Fed.

tion of the patient be considered in NAS-BEIR report. erst. State and professional gToups atil NRC's regulation of the medacal use of in the foreseeable future the er.ajor cen- not be able to prevent future incidents baroduct material? tnbu ori to racauen exposure of the popw.

in the med' cal uses of radJolsotopes.

From the standpoint of culAority, it latlon wt!! continue to be catural baca.

is clear that NRC can regulate the tround aIth as aversee shote body dose of The Commission recorntzes that medicaj uses of byproduct material to about 100 enrem/ rear. and med: cal apo!!ca. TDA regulates the manufacture and protect the health and safety of users tions which now centribute comparable es. Interstate distribution of drugs. Lnclud.

of this material. for Instance, patienta. posures to various stasues cf the body. Medi. Ing those that are radioactise. FDA In licensing the possession a.nd use of m3 uposures are not under control or guld. also regulates the investigational and byproduct matettal. NRC establishes ance by regulation or law at present. The research uses of drugs as sell as the limits within which physicians exer. use of tonens recauen in medicine is of specific ruldance on doses and proce.

case professional discretion. From the f,'d x s ca o dures found LD the product labchng standpoint of polfey. these limits plished without loss of benef!t a.nd at rela. Hosever. FDA does not hate the aa.

l depend upon how NRC views the po- tiveir low cost. The atm ts not ort!r to thority to restrlet the routine use of tential hat.ard to the patient's health reduce the ts.d:stion exposure to the indi. drugs to procedu.res (described in the and safety in the uses of the byprod. W.ual but siso to r.sve procedures carned product labeling) TDA hu approtcd uet matertal. The greater the potential out a.ith mazircuci effletency no that tt:ere as safe and effective. Indeed. NRC ts hazard to a patient from the byprod. can be a cent' cuing increa.se in c:.ed. cal the only Federa.! Agency that is cur.

I uct matenal or its use by a physician, benefits accomparJed by a r:cn:mu n rado rently autitor1*ed to regulate the rcw

] the more NRC may elect to circum. ation uposure. tine use of rad;oacute drugs from the 9 scribe areu that might otherwise be NRC sill act to he'p ensure that ra. standpoint of reducing unnecessary ra.

regarded u within the discretion of dlation exposure to pat!ents is u low d:ation exposure to patients.

.! the physician. as is reasocably achievable, cons:. stent The Commission believes that the

The first part of NRC's policy state- sith competent medical care and with diagnostic use of radioactive drugs ts.

ment indlestes that NRC s1ll continue minimal intrusion into medical judg. In most cases, cleuly an area of low j to regulate the medical uses of radiol- ment NRC sill not exere!se r:gula- radiation risk to patients. Therefore.

, sotopes as necessary to provide for the tory control in those areu there. NRC will not control physician's pre-radiation safety of workers and the upon careful examination, it deter

• rogauves on patient selection. tr'stru. '

genertl pub!!c.* This is the tradillonal mines that there are adequate r

• ruta- ment selectjon, procedure selection.

regulatory function of NRC for all tions by other Federal or State iten. drug selecuon and dose lesel for mctst uses of byproduct, source and special cles or well administered profess!onal diagnosuc um og % Mopes. For nuclear matertal. It ts a regulatory standards. Wherever poss:ble. NRC 1

' all therapeutic uses of rad 2cacth e role that was not questioned by any of will work closely with Federal and the commenters but, rather. It was State agencies and professional groups drugs, and in certain djarnostic uses-consistently recognized u a necessary in designing new voluntary ru dance for example, the use of puosphorus 3. ,

role in the medics.! uses of radioiso. for practitioners to limit unnecessary for locamation of ne tumostbc tcpes. patient radiation exposure. risk to paUents is not low. The mk of NRC's regulation of the radiation The th]rd part of NRC's policy st. ate. tissue or orts.n damage (or even death) l safety of workers and the general ment indlcates that NRC will mini. Ls inherent in the se of therapeutic public in the medical uses of radioiso. mize its intrusion into medical judg. levels of radioacute drugs. NRC wi;l tepes is relinquished by NRC to Agree. ments affec'ing the patient and into continue to restrict the uses of thera- I ment States; does not overlap with other treu traditionally considered to peutic and certain diagnosue radtoso l FD A's activit!es: Ls in harmony with be a part of the practice of medicine, tive drugs to the indicated procedures i regulation by the Department of The Commission recognizes that phy. that have been approved by FDA. The Transportation. Social Security Ad. sletans have the primary responsib!Mty NRC will not control the physicians' I ministradon and the Joint Commts. for the protection of thelt patie nts. prerogatives on patient selection and sion on Accreditation of !!ospitals; and The Commission believes that basic instrument selection for therapy pro.

dovetails with Occupational Safety decisions concere! . the diagnosts and .cedures because these procedures are and 11ealth Administration regulation treatment of d.sease ad a part of the so specialized and patient spectfac.

of the work place for the use of natu. physician-patient relation /. hip and are Congress recently gave FDA authon.

rally occurring and accelerator-pro, traditionally considered to be a part of ty to regulate medicsJ dedcts. similar duced radtoactive materials. the practice of rsedicine. (RC regula. to FDNs authority to regulate drugs.

The second part of NRC's polley tions are predicated on t!.e sAsumption but with additional authority to re-statement indicates that NRC st!! reg. that property trairvd and adequately strict the routine use of medical de-utste the radiation safety of patients informed physicians stu make decs. vices as may be necessary to provide where justified by the risk to patients storu in the best L..terest of the.t pa' reasonable assurance of their safety l and there voluntary standards. or U"l and effectiveness. FDA has not let '

compliance with these standards. are had sufficient time to implement its inadequate. As noted before. NRC hu

• Nations! Acadenir of Sc'enees Addsory full authority to regulate medical de-the authority to regulate the rad!stion Committee on the BiolcetcAl Ufects of Ion- vices containing byproduct. Source or safety of patients. tzins Radations (NA.5-BC.R) report. W special nuclear material. Therefore. l t/hets os Peps!attons c/ Erposure to Low MC will continue to restrict phys!-

Levets of lonutne RadtatM Not;onal me term eeneral riublic in this state. A eodemy c/ Setences-Nettonal Resea cri clan's uses of these medt:al dences.

rnent specifica!!y encludes patients. Comest Washington. D C.119tD. both for diagnosis and therapy to f tDilat 18C11r11. VOt. a4. NO. M itfDaY, f fitUntY 9. hie l

RULES AND REGULATIONS 8244 Two cornmenters objected to NRC's As noted In the proposed cohey those procedures that NRC has det:r- regulation of patient radiation safety statement. fous alliedNRC is studying health the pro.

certificat!cn var l mmed (in consultation with its Adviso- because they believe that NRC does gruns currently in effect or being ry Committee on the Medical Uses of not have the authority to regulate pt.

1sotopes) to be safe and effective. drafted by other Federal. State and tient safety. They note that NRC's en. profess!onal gToups. If the coserage The Commission does not consider equipment calibration, cualifications ab!!ng legislation does not specifically provided by these prog?arns is not ade-of paramedical personnel or reporting rnention the radiation safety of pa. quate to protect the patient from un. j l

to NRC misadministrations of radioac- tients. They believe that patient necessary radfatlon exposure. NRC r the msterial to te exclusively the safety is the responsib!!!ty of the phy. till work with these gToups to deselop  !

practice of medicine or a part of phys!- sician. a responsibi!!!y that cannot be a new HEC proposed rule for the cian-patient relationshtps. The Com- shared. They belfere that the Commis. training of a!!1ed health personne!.

rnission intends to regulate these areas slon is in error to equate patients with There acre five comments on the l

of patient radiation safety there justi- the pub!!c and to consider patients as specific subject of nuclear pharmatics

('

fled by the risk to patients sad where users rather than rec!Dients of radio, (radiopharmacles),

voluntary standards, or compliance active materf aj. One commenter urged NRC to d:s.

alth these standards, are inadequate. As noted in the analysts of the simg. tinguish between radlopharmactsts j

lar comment above, the NRC's overrtd- torking in a hospital setting and those l  !!!. Disecssics or Pttstic CowucNTs ing congressional mandate is to pro. working in a retail environment (com- l A. CowMENTs oM THE rot!CY sTArWINT tect the health and safety of the mercial nuclear pharmacy). This com;  ;

[ pub!!c.The patient is a member of the menter also noted the comp leuty o.

One cornmenter opposed the use of pub!!c. r.ctwithstandlng the Commis, the problem of definition t hen the j the general term " radioisotopes" in ston's recognition of phys!cians' prima- hospital based radiopharmacy pro-the first put of the po!!cy statement. ry respons!b!!!ty for protection of vides radiophumaceuticals to other I This commenter sas concerTted that, their patients. The polley statement hospitals and practitioners in its area, if taken out of the context of the foot, and. Indeed, all of the Commission's As noted in the proposed policy note,it could be interpreted to include actions in regulating the reedical uses statement, tM nRC sill defer to the naturally occurring and accelerator of radioisotopes, acknowledge the sec- Food and Drug Aimintstratton (FDA) produced radio!sotopes, ondary but necessary role cf NRC in regardln/ a determination of those ac- 1 The Cor". mission believes that the general term " radioisotopes" is plain regulating the rad!ation safety of pa- tivities of nuclear pharmacles that s111 1

1 Eng!!sh and easily recognized by the tients. The Commission also constders be constdered manufacture and those public. It was preperly footnoted in patients to be both users and recipi- activities that will be considered the the policy statement to include the ents of radioactive material. However, ordinary practice of pharmacy (com- l l

more eumbersome but specific term.s: the distinction .between receipt and pounding and dispensing).

byproduct, source and special nuclear use of radioactive mat!rnis is not Four commenters objected to NRC's material and to exclude naturally oc. meaningful in this case because NRC licensing nuclear pharmacies to dis.

curring and accelerator produced ra- regulates, among other things, receipt. tribute only those products that they duac *lve risterial, possession, use and transfer of byprod- have prepared from FDA approsed -

One commenter. In opposition to uct source and special nuclear matert- radiopharmaceuticals or reagent kits.

NRC's regulation of patient radiation u tn protecting the he11'.h ird stfety Cne car. tenter c'ted the practice of .

safety, suggested that NRC limit its of the public. nuclear pharmacies supplying radio.

role to the rad!stion safety of the hos. chemicals to researchers s ho use pital staff and the general patient a. ccMarIFTs on stretric tsstIs them on humans under their ou n population. He believes thtt patten; There were six comments on the FDA " Notice of Claimed Investigation.

destrnetry ts a responsibility of the in- cuestion of reporting misadministra* al F.xemption for a New Drug" (fNDL dividualinstitution and not h?.C.This t of radioactive matertal. Three One commecter noted that FDA per.

commenter feels that NRC should c unenters opposed any m!sadminis- mits nuclear pharmacies to operate in first require adequate staffing, h..lud- tration reporting and three com- the absence of a final determinthon of ing a board cert 1 fled physician or rar menters offered suggestions on how their status, providing they meet all diopharmacist and a radiation safety they should be reported. All of the State and local charmaceutles.1 teruls.

officer sad then essent! ally leave the comments will be considered in dealing tions. The two other commenters Institution alone regarding dostmetry, with NRC's newly proposed mtsadmin- charactertted the NRC's restrictions of instrumentation, calibration, drug pro- istration reporting requirement that on the distribution curement or any other function con. s'as published in the Fr:rxAt. RscisTrn radiopharmaceutleals by nuclear phar-sidered to be the practice of medicine. for pub 11c comment on July 1.19'l8 (43 mactes a.s an unwarranted intruston NRC does require the licensee to FR 29291). Into the practice of pharmacy ahich is staff its operation with a radfation There were six comments on the spe. regulated by the States.

safety offleer and a physician (not cific issue of paramedical training. NRC licenses nuclear pharmacies to necessarily board certilled) trained to Three commenters believe that it is distribute radioactive drugs that hnse administer radioactive material or ra. unnecessary for NRC to become in. been approved by FDA. This includes dlation to patients. However, the Com. volved in paramedical tralning because radlosctive drugs subject to an FDA-mission cannot limit its regulatory role several ottan! rations are already pro.(ND approv ed "New Drug Application" A), or " Notice of Claimed Investi.

to protecting the hospital staff and viding or developing minimum stand. rational Exemption for a New Drug" the general patient population and at ards, guidelines cr certification. One (IND). NRC relles on FDA approval of the mandatesame to time fulfillthe protect its congressional health and commenter be!!eved that NRC should radioactive drugs because NRC ha.s safety of the rubtle as regards source, be involved in this area because the not regulated the safety and effective.

byproduct and special nuclear mater 1 technologist. not the phystelan, does ness of radioattive drugs since 1975.

at The patient being treated or d!ag. most of the work with radlotsotopes. Also, there are not many States that nosed with radioactive material, as Two commenters believe that radiolog- are equipped to regulate radioactne sell as the general public she may be leal physictsts should be separated out drug safety and effectiveness.

exposed to rad!ation u a result of that from other pararnedical personnel and Dated at Ws.shington, D.C. this 1st treatment, are all members of the one of these commenters offered a day of February 1919.

pubtle to be protected by NRC. definition of radiological phystetst.

e f! Dis At sf 01$ylg. YOL. a4, NO. 29 FalD AY, PtssUssy 9, left .

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