ML20202D641

Seeks Commission Approval of Final Statement of General Policy That Identifies NRC Future Role in Regulation of Medical Uses of Byproduct Matl

ML20202D641
Person / Time
Issue date:	11/22/1978
From:	Minogue R, Casey Smith NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS), NRC OFFICE OF STANDARDS DEVELOPMENT
To:
References
SECY-78-068, SECY-78-614, SECY-78-614-R, SECY-78-68, NUDOCS 9902020057
Download: ML20202D641 (45)

Text

{{#Wiki_filter:- ,, y' UNITED STATCS "ucma acca^?oav coaarssion SECY-78-614 i wiovem8er 22. ce j CONSENT CALEND AR ITP" For: The Comissioners Robert B. Minogue Director, V.ce of Standards Development Clifford V. Smith, Director, uffice of Nuclear Material Safety s From: and Safeguards ~ Executive Director for Operations I Thru: NRC REGUt.ATION OF THE MEDICAL USES OF BYPRODUCT MATERIA

Subject:

To seek Comission approval of a final statement of general policy that identifies NRC's future role in the regulation of the medical purpose: uses of byproduct material. This paper covers a major poli:y question. q Category: At the March 2,1978 policy session the Comission approved for Discussicn: publication in the Federal Register a proposed medical policy statement (SECY-78-68). The policy statement was published on March 17,1978 for a 60-day public comment period that ended on I ..^ Copies of the policy statement were sent to all May 17,1978. NRC medical licensees, the States and 25 professional societie., Federal agencies, and individuals. Nine commenters favored all y Twenty-two coments were received. three parts of the policy statement, four comenters opposed one 4 part of the policy statement and nine comenters addressed other 8 is specific issues in the Federal Register notice. Enclosure 1, a draft Federal a summary of the public comments. Register notice of a final medical policy statement, includes a j sumary and analysis of the significant comments. The three part statement of policy in Enclosure 1 is the same as _ f that proposed in the March 17, 1978 Federal Register notice and f reads as follows The NRC will continue to regulate the medical uses of $[' 1 l 1. radioisotopes as necessary to provide for the radiation safety of workers and the general public. The NRC will regulate the radiation safety of patients l 2. where justified by the risk to patients and where volun-l tary standards, or compliance with these standards, are l inadequate. f/ 1 4 4

Contact:

? h Ed Podolak 443-5946 ~ g2O 7 781122 p 78-614 R PDR

• The Comissioners

. NRC will minimize intrusion into medical judgments 3. affecting patients and into other areas traditionally con-sidered to be a part of the practice of medicine. Three comenters who objected to the proposed policy statement = challenged NRC's authority to regulate patient radiation safety. 1)HRC'senabling They challenged NRC's authority on the basis of: legislation does not specifically mention patient radiation safety,

2) the patient is not a member of the public, and 3) the physician's i

A fourth com-responsibility for patient safety cannot be shared. menter objected to the use of ti.e general term " radioisotopes." The NRC has always considered the patient as a member of the public The NRC also has to be protected by its regulatory activities. consistently recognized, and indeed the policy statement reflects, that physicians have the primary responsibility for the protection of their patients. NRC's congressional n.andate to protect the health and safety of the public encompasses the general public, workers and patients. Recomendation: That the Comission: Approve publication in the Federal Register of the final R I 1. statement of general policy regarding NRC's future role in l regulating the medical uses of radioisotopes (Enclosure 1). 2. Note: All medical licensees and the appropriate congressional a. committeeswillbeinformed(Enclosure 3). A public announcement, such as Enclosure 2, will be b. issued when the policy statement is filed with the Office of the Federal Register. The Offices of Inspection and Enforcement, State Programs, Policy Evaluation and the Division of Rules and Records concur in t Coordination: The Offices of the Executive Legal reconinendation of this paper. The Director and the General Counsel have no legal objection. draft public announcement was prepared by the Office of Public Affairs. OCA concurs. ( l 3 i

l 3 I' The Comissio- .3 ~~ /.... ' ' * ' !... y.. ~ Cli d V. Smit, Direct Robert B. Minogue, Director Of i e of Nuclear Materi s Safety Office of Standards Development d Safeguards

Enclosures:

1. Federal Register Notice of Policy Statement 2. Draft Public Announcement 3. Draft Congressional Letter 4 Sumary of Public Comments 5. Federal Register Notice of Proposed Policy Statement v Comissioners' coments or consent should be provided directly to the Office of the Secretary by clore of business Friday, December 8,1978_. Comission Staff Office coments, if any_, should be submitted to the Comissioners If with an information copy to the Office of the Secretary. NLT November 30, 1978, the paper is of such a nature that it requires additional time for analytical review and coment, the Comissioners and the Secretariat should be apprised of when coments may be expected. This paper is tentatively scheduled for affirmation at an Open Meeting during the W Please refer to the appropriate Weekly Comission Schedule, when December 11, 1978. published, for a specific date and time. DISTRIBUTION Comissioners Comission Staff Offices Exec Dir for Operations Regional Offices T Secretariat .f: ) 4

~- ~ ..2* ...;,v.y s . L.. . n ., s.._,. ;,,.,. s.. ;. n y. ..;.. f

j

,r ), ": ;. * ., e. -.]  ;;. ;f. / y;W;,.',,;.:..J.,3 r .....,m ' ';.:i, u !.'.'.,g '4;}/ 1,). $, y @ @a ~ ".;*. g,. ig. i ,e (..4 f -m. ... ;,/....; . c.:, ;. _.. .... ~.. , ; y & l,. J. ' 3:,. 4

5. 0, c,4

• r
• e:.. (.:

.s .:n,y... ., ;i. = y. ; :.:: [ ,. c. :y;.. y * ....; 1,, j,t y, _. t h f'h.'- .k.:.,le&.l~ ~ ' I .e ~ ,k, f,,$.f' i.y V .f% t; pit.q p,~ ?^'it.-g' [ -{ 'i.' ] $ h f k,[ ( .[f3 d'Y ! ? .C %. ' . i;)f,p &,..$..e;Y ' '8, Jd Q.;.' :'. J c?.V,.3'i 'h.hh},T%$v,&Qf,,s.'.h

a.

NM

?j0d.?

' '^ ^ .j . b;w.; ;h

v,..yu.n s.

..t V,p .W ..n...' .+ v : >. v. w. :. . v..;n,y,J:, p,..q., ic. a n. ':r ~. n. w -.c..:. ' '3-

: ? m y &,.

~ ~. c .. $y y,.4:y:*.L,. . ;,, t. . u.,, ;. . oj (. s,. ..k,.;.'.s .. <.s.. s. ?,1 .stp : 6 ,;L. g.y/,.g.

/. *.

.,i .t g y r y L.... ., 'w./ c.a .e .*'j,/.;, g,,, ' [ 5 is,., p **'- 2 4 . si. 'I ,.1 ... N.. n,,,- },P, a

f,;.,..

f2 s , dd'f.'$,'g'f.%,,., i. ' h.f...., :.,.. r - ENCt.05URE. ;,1..W / .f R, ..,,/- e s.... r. <*E.T . ;..,., * : ' i. '. J. $I,r .. 'g p.', .l;y;;;.;.";.%$,f,r}I' 1 pp h j,'.h ,M. ' [, $,W 'y aC 1 t g s9:, e ,7 '. u;.,s.:r~.1.5 t \\ .c ? 1,. r. ~ 'Q ', y.)f:./e~ ' :,','s 'f ' '.4; 'f ,#,Q. c, y. ., &,:..t p,h.....'s*%... m. ;. ;-., t o f, t V l;'. .. d.. ;;x.., h. a q%,.:.....' k.,~,:,';.,v. .n,, q.y..{'.],- .,. y,,;i p .e. ,y

b.,. ;

4 M. y g)d b d!!g m $s h M hh h k g 5s wk _ pa me p& w@V. w:w.~a..e;.: d. m w" 7 w&a.q.*w,Q:,,T.:.- . T. lwl.. ~.2.,.. 6.:k$.k...: 4p s'hs - F? .p. n. l '., ha' .j.....:..5

• c

, l. f" q,g -f,,/** ~, 5~

• ?

y. ; 5::: p: w.:4.,.; _ p%(. \\ ,\\' Ie.. V".N, 4. ,g - vy by" ; qew 'f 1 ~ 'e '. + sa e,.g, (t. f g.9 f.; ? _,:.; O. ;. ;. 3. .s s 3 r .s ..m.

s. ; ( C 3,

. f........:' 7;g:,1. ..,g..,.. ; s;...,. - }, '.. - ....,~,.c pui, ,;,7,r. ,s. p . :....; o.- w

• 1. *. A ie. 'g

.[. r. , s' t'. ,4 ,, '" I * ~U., f 8 * '.

'. R ll

.:, v..i.._.;...... 4 4 e . y g G .y' a g

1. '""^#w"

• 4.m2,e.

a, C, ' ~ NUCLEARREGULATORYd,0MMISSION REGULATION OF THE MEDICAL USES OF RADI0 ISOTOPES STATEMENT OF GENERAL POLICY The Nuclear Regulatory Comission (NRC) has developed the following three part policy statement regarding NRC's future role in regulating the medical uses of radioisotopes. 0n March 17, 1978, the three part policy statement was published in the FEDERAL REGISTER (43 FR 11200) for public Copies of the policy statement were sent to all NRC medical licens-coment. ees, the States and 25 professional societies, Federal agencies, and indi-viduals. The coment period expired May 16, 1978. Twenty-two comments were Nine comenters favored all three parts of the policy statement, received. four comenters opposed one part of the policy statement and nine comenters addressed specific issues discussed in the March 17, 1978 FEDERAL REGISTE The coments are discussed in Section II. Copies of coments may notice. be examined in the NRC Public Document Room at 1717 H Street, N.W., For further information contact Edward Podolak, Office of Washington, D.C. Standards Development, U.S. Nuclear Regulatory Comission, Washington, D.C 20555(Phone: 301-443-5946). I. STATEMENT OF GENERAL POLICY This NRC policy statement is intended to inform NRC licensees, other Federal and State agencies and the public of the Comission's general int It is tion regarding the regulation of the medical uses of radioisotopes. expected that future NRC activities in the medical area, such as ft closure 1

\\ y ggr @ s~ l of new regulations and developmerit'of coope- . relationships with other Federal agencies, will follow this - ... ant of NRC policy. Based on past experience .a the coments and advice of the public, other Federal agencies, tne States and NRC's Advisory Comittee on the Medical Uses of Isotopes, the Coanission has developed the following state-ment of general policy to guide its regulation of the medical uses of radioisotopes:I The NRC will continue to regulate the medical uses of radioisotopes i 1. as nee.essary to provide for the radiation safety of workers and the general public. The NRC will regulate the radiation safety of patients where 2. justified by the risk to patients and where voluntary standards, or compliance with these standards, are inadequate. The NRC will minimize intrusion into medical judgments affecting 3. patients and into other areas traditionally considered to be a part of the practice of medicine. byproduct, source and INRC licenses radioisotopes in three categories:The NRC does not regulate n special nuclear material. The tem byproduct material _ means any accelerator produced radioisotopes. radioactive material (except special radioactive by exposure to the radiation incident to the process of produc-The term source material means ing or utilizing special nuclear materic1. (1) uranium, thorium or any combination thereof, in any physical or chem form or (2)(ores which contain by weight one-twe i) uranium, (ii) thorium or (iii) any combination thereof. Source Special nuclear material or more of material does not include special nuclear material. means (1) plutonium, urania 233, uranium enriched in the isotope 233 or in the isotope 235 or (2) any material artificially enriched by any of the foregoing, but does not include source material, g. 2 h, =

s', s' II." RATIONALE . iiRC and its predecessor the Atomic Energy Comission have regu-c' lated the medical uses of radioisotopes since 1946. AEC recognized that physicians have the primary responsibility for the protection of their patients and designed its regulations accordingly. The physicians were required to be licensed by the State, and their applicable training and experience were evaluated in consultation with the Advisory Comittee on This regulation has been generally oriented the Medical Uses of Isotopes. toward assisting qualified physicians in discharging their responsibilities However, regulation by AEC/NRC has at one time or another to patients. encompassed nearly every aspect of the delivery of radioisotope medical The broadest regulation occurred between 1962 and services to patients. 1975, when the Food and Drug Administration (FDA) exempted from its require-During ments for new drugs all radiopharmaceuticals regulated by AEC. this period AEC regulated the radiation safety of workers and the general public and_ the safety and efficacy of radioactive drugs and devices with AEC regulation included production of the radioisotope, respect to patients. manufacture of the final radioactive drug product or device, distribution, use and disposal of the products. In 1975, the FDA terminated the exemp-tion for radiopharmaceuticals, stating that it would now regulate the (As safety and efficacy of radioactive drugs with respect to patients. noted later in this statement, FDA does not regulate the physician's routine use of radiopharmaceuticals.) At the same time, NRC withdrew from regulating radioactive drug safety and efficacy, stating that it would regulate the radiation safety of the workers and the public.h.The 1976

• t 3

m, e-G

i I Medical Device Amendments to the Food Drug and Cosmetic A'ct extended FDA's authority over medical devices (in'cluding devices containing radioactive materials) in a way similar to its authority over drugs. NRC's authority to regulate domestically the medical uses of byproduct For material is found in the Atomic Energy Act of 1954, as amended. example, section 81 of that Act authorizes NRC "to issue general or specific licenses to applicants seeking to use byproduct material for... medical therapy...." Section 81 directs NRC to regulate the manufacture, production, transfer, receipt in interstate commerce, acquisition, owner-

Finally, ship, possession, import and export of byproduct material.

Section 81 also directs that: The Comission shall not permit the distribution of any byproduct material to any licensee, and shall recall or order the recall of any distributed material from any licensee, who is not equipped to observe or fails to observe such safety standards to protect health as may be established by the Comission or who uses such material in violation of law or regulation of the Commission or in a manner other than as disclosed in the application therefor or approved by the Comission. Comission regulations, for the most part set forth in 10 CFR Parts 30 through 35, were promulgated to carry out the broad regulatory scheme envisaged by section 81. For example, Part 35 establishes regu-FDA's statutory lations specific to human uses of byproduct material. authority (Federal Food, Drug and Cosmetic Act, as amended, 21 U.S.C. 301 Where NRC's and FDA's author- _et seq.) does not diminish NRC's authority. ities overlap, the respective authorities can be harmonized by interagency agreement. [Enclostre 1 4

C The central question is a question of policy not au'thority, namely: I To what extent should the protection of the patient be considered in NRC's regulation of the medical use of byproduct material? From the standpoint of authority _, it is clear that NRC can rr.. ate the medical uses of byproduct material to protect the health and safety of users of th,is material, for instance, patients. In licensing the possession and use of byproduct material, NRC establishes limits within From the standpoint which physicians exercise professional discretion. of policy, these limits depend upon how NRC views the potential hazard to the patient's health and safety in the uses of the byproduct material. The greater the potential hazard to a patient from the byproduct material or its use by a physician, the more NRC may elect to circumscribe areas that might otherwise be regarded as within the discretion of the physician. The first part of NRC's policy statement indicates that NRC will continue to regulate the medical uses of radioisotopes as necessary to provide for the radiatio'n safety of workers and the general public This is the traditional regulatory function of NRC for all uses'of It is a regulatory role byproduct, source and special nuclear material. that was not questioned by any of the comenters but, rather, it was consistently recognized as a necessary role in the medical uses of radioisotopes. NRC's regulation of the radiation safety of workers and the general public in the medical uses of radioisotopes is relinquished by NRC to 2The tenn general public in this statement specifically excludes patients. IEnclosure 1 5

- ~ - - - _ _ - -. _ _ t \\- j f i i f Agreement' States; does not over1ah with FDA's activities * ".. harmony .scial Security with regulation by the Department of Transportati-i 1j-I Administration and the Joint Commission on f.reditation of Hospitals; i and dovetails with Occupational Safety and Health Administration regula- \\ I f tion of the work-place for the use of naturally-occurring and accelerator-f produced radioactive materials. The second part of NRC's policy statement indicates that NRC will i regulate the radiation safety of patients where justified by the risk to i l patients and where voluntary standards, or compliance with these standards, i i As noted before, NRC has the authority to regulate the j are inadequate. i radiation safety of patients. l The NAS-BEIR report discusses limiting the exposure of the popula-1 3 l tion to medical applications of ionizing radiation. That report, which 4 includes all medical uses of ionizing radiation, shows an average dose ) rate from radiopharmaceuticals of 1 mrem / year and an average dose rate i from diagnostic radiology of 72 mrem / year in 1970. i i The following quotation is from the NAS-BEIR report: In the foreseeable future, the major contributors to radiation exposure of the population will continue to be natural back-ground with an average whole body dose of about 100 mrem / year, i i and medical applications which now contribute comparable expo-l Medical exposures are sures to various tissues of the body. not under control or guidance by regulation or law at present. The use of ionizing radiation in medicine is ci tremendous value l but it is essential to reduce exposures since this can be accomplished without loss of benefit and at relatively low i The aim is not only to reduce the radiation exposure to cost. i i National Academy of Sciences Advisory Committee on the Biological Effects 3 The Effects on Populations of_ ofIonizingRadiations(NAS-BEIR) report. National Academy of Sciences - j Exposure to Low Levels of Ionizing Radiation. J National Research Council _, Washington, D.C., (1972). l 6 i

) O .. ve ' procedures carried out with the individual but also.iac there can be a continuing increase maximum efficiency in medical bencM a accompanied by a minimum radiation exposure. t to help ensure that radiation exposure to patients NRC will t t medical is as low as is reasonably achievable, consistent with compe en NRC will not care and with minimal intrusion into medical judgments. exercise regulatory control in those areas where, upon careful examina-tion, it detemines that there are adequate regulations by other Federal Wherever or State agencies er well admir.istered professional standards. possible, NRC will work closely with Federal and State agencies and pro-fessional groups in designing new voluntary guidance for practition2rs to limit unnecessary patient radiation exposure. The third part of NRC's policy statement indicates that NRC will minimize its intrusion into medical judgments affecting the patient and into other areas traditionally considered to be a part of the practice of j l The Comission recognizes that physicians have the primary medicine. The Comission responsibility for the protection of their patients. believes that basic decisions concerning the diagnosis and treatment of disease are a part of the physician-patient relationship and are tradi-NRC regu-tionally considered to be a part of the practice of medicine. lations are predicated on the assumption that properly trained and ade-quately informed physicians will make decisions in the best interest of their patients. The regulations try to find a balance between adequate controls and ^ A consequence of avoidance of undue interference in medical judgments. V 7

F'. too much regulation could be pooNr health care delivery fo patients. A consequence of leaving to physicians the majority of the decisions con-The cerning their patients is that the physicians will make mistakes. tightest regulation of physicians' decisions by Federal, State and pro-fessional groups will not be able to prevent future incidents in the medical uses of radioisotopes. The Commission recognizes that FDA regulates the manufacture and interstate distribution of drugs, including those that are radioactive. FDA also regulates the investigational and research uses of drugs as well as the specific guidance on doses and procedures found in the product However, FDA does not have the authority to restrict the routine labeling. use of drugs to procedures (described in the product labeling) FDA has approved as safe and effective. Indee'd, NRC is the only Federal Agency that is currently authorized to regulate the routine use of radioactive drugs from the standpoint of reducing unnecessary radiation exposure to patie'nt:. The Commission believes that the diagnostic use of radioactive drugs is, in most cases, clearly an area of low radiation risk to patients. Therefore, NRC will not control physician's prerogatives on patient selec-tion, instrument selection, procedure selection, drug selection and dose For all therapeutic uses level for most diagnostic uses of radioisotopes. of radioactive drugs, and in certain diagnostic uses-for example, the use of phosphorus-32 for localization of eye tumors-the risk to patients is not The risk of tissue or organ damage (or even death) is inherent in the low. 8 G. M' s

. - ~. use of therapeutic levels of rad'iIactive drugs. NRC will" continue to restrict the uses of therapeutic and certain diagnostic radioactive I The drugs to the indicated procedures that have been approved by FDA. NRC will not control the physicians' prerogatives on patient selection and instrument selection for therapy procedures, because these proce-dures are so specialized and patient specific. Congress recently gave FDA authority to regulate medical devices. l canal authority similar to FDA's authority to regulate drugs, but with adt to restrict the routine use of medical devices as may be necessary to FDA provide reasonable assurance of their safety and effectiveness. has not yet had sufficient time to implement its full authority to regu-late medical devices containing byproduct, source or special nuclear Therefore, NRC will continue to restrict physician's uses material. of these medical devices, both for diagnosis and therapy, to those pro-cedures that NRC has determined (in consultation with its Advisory Committee on the Medical Uses of Isotopes) to be safe and effective. The Commission does not consider equipment calibration, qualifica-tions of paramedical personnel or reporting to NRC misadministrations of radioactive material to be exclusively the practice of medicine or a part The Comission intends to regulate of physician-patient relationships. these areas of patient radiation safety where justified by the risk to patients and where voluntary standards, or compliance with these are inadequate. 4.n 9 1 ~

~- -. - -. _ _ _ _ _ _ _ _ r.- ~ DISCUSSIONOhPUBLICCOMMENTS III. A. Coments on the Policy Statement C " radioisotopes" in One comenter opposed the use of the general ' the first part of the policy statement. This comenter was concerned that, if taken out of the context of the footnote, it could be interpreted to include naturally occurring and accelerator produced radioisotopes. The Comission believes that the general term " radioisotopes" is plain English and easily recognized by the public. It was properly footnoted in the policy statement to include the more cumbersome but specific terms: byproduct, source and special nuclear material and to exclude naturally occurring and accelerator produced radioactive material. One commenter, in opposition to NRC's regulation of patient radiation safety, suggested that NRC limit its role to the radiation safety of the He believes that hospital staff and the general patient population. patient dosimetry is a responsibility of the ind,1vidual institution and This comenter feels that NRC should first require adequate staffing, not NRC. including a board certified physician or radiopharmacist and a radiation safety officer, and then essentially leave the institution alone regarding dosimetry, instrumentation, calibration, drug procurement or any other function considered to be the practice of medicine. NRC does require the licensee to staff its operation with a radiation safetyofficerandaphysician(notnecessarilyboardcertified)trainedto However, the administer radioactive material or radiation to patients. Comission cannot limit its regulatory role to protecting the hospital b staff and the general patient population and at the same time fulfill its y AEnclosure 1 10

.s E ath and safety of the public as congressional mandate to protect regards source, byproduct

• ecial nuclear material. The patient being e

treated or diagnosed .un radioactive material, as well as the general public who may be exposed to radiation as a result of that treatment, are all members of the public to be protected by NRC. Two comenters objected to NRC's regulation of patient radiation safety because they believe that NRC does not have the authority to regulate They note that NRC's enabling legislation does not specifi-patient safety. 4 cally mention the radiation safety of patients. They believe that patient safety is the responsibility of the physician, a respons bility that can-not be shared. They believe that the Commission is in error to equate patients with the public and to consider patients as users rather than recip-ients of radioactive material. As noted in the analysis of the similar coment above, the NRC's over-riding congressional mandate is to protect the health and safety of the public The patient is a member of the public, notwithstanding the Comission's recognition of physicians' primary responsibility for protection of their l l The policy statement and, indeed, all of the Comission's actions patients. in regulating the medical uses of radioisotopes, acknowledge the secondary but necessary role of NRC in regulating the radiation safety of. patients. The Comission also considers patients to be both users and recipients of However, the distinction between receipt and use of radioactive material. r radioactive materials is not meaningful in this case because NRC regulates, among other things, receipt, possession, use and transfer of byproduct, source and special nuclear material in protecting the health and safety of the public. g 11

Coments on Specific Issues are six coments on the question of reporting misadministrations Tu .adioactive material. Three comenters opposed any misadministration \\ reporting and three comenters offered suggestions on how they should be All of the coments will be considered in dealing with NRC's newly reported. proposed misadninistration reporting requirement that was published in the FEDERAL REGISTER for public coment on July 7,1978(43FR29297). There were six coments on the specific issue of paramedical training. Three comenters believe that it is unnecessary for NRC to become involved in paramedical training because several organizations are already providing One commenter or developing minimum standards, guidelines or certification. believed that NRC should be involved in this area because the technologist, Two comenters not the physician, does most of the work with radioisotopes. believe that radiological physicists should be separated out from other paramedical personnel and one of these comenters offered a definition of radiological physicist. As noted in the proposed policy statement, NRC is studying the various allied health certification programs currently in effect or being drafted by other Federal, State and professional groups. If the coverage provided by these programs is not adequate to protect the patient from unnecessary radia-tion exposure, NRC will work with these groups to develop a new HRC proposed rule for the training of allied health personnel. There were five comments on the specific subject of nuclear pharmacies (radiopharmacies). One commenter urged NRC to distinguish between radiopharmacists working in a hospital setting and those working in a retail environment (comercial 12

e, e nuclear phannacy). This coment[r aIso noted the complexity of the problem of definition when the hos' ital based radiopharmacy provides radiopharmaceu-p ticals to other hospitals and practitioners in its area. As noted in the proposed policy statement, the NRC will defer to the 4 Food and Drug Administration (FDA) regarding a determination of those t l activities of nuclear pharmacies that will be considered manufacture and those activities that will be considered the ordinary practice of pharmacy (compounding and dispensing). Four commenters objected to NRC's licensing nuclear pharmacies to distribute only those products that they tave prepared from FDA-approved radiopharmacenticals or reagent kits. One comenter cited the practice of nuclear pharmacies supplying radiochemicals to researchers who use them on humans under their own FDA " Notice of Claimed Investigational Exemption for a New Drug" (IND). One commenter noted that FDA permits nuclear pharmacies l to operate in the absence of a final determination of their status, provid-The two ing they meet all State and local pharmaceutical regulations. other commenters characterized the NRC's restrictions on the distribu of radiopharmaceuticals by nuclear phannacies as an unwarranted intrusion into the practice of phannacy which is regulated by the States. NRC licenses nuclear pharmacies to distribute radioactive drugs that This includes radioactive drugs subject to an have been approved by FDA. FDA-approved "New Drug Application" (NDA), or " Notice of Claimed Investig tional Exemptiun for a New Drug" (IND). NRC relies on FDA approval of radioactive drugs because NRC has not regulated the safety and effectiveness 13 -l I

4 mand 4mrd wJ.%h MJJpA ais e. HAM.h S A4.*4 6.M a.#,.4m.,.ea.,.BA4.hM. A WadB45.he&dmia44me d.44 64*-MeamWh s.-mem.sve-am m.m. - dmisur + ; e mam..,.sm.a.L4.m.e4.u-.s_ 3,o__am_m_, a u. El hr.p: .e e 't.g. 4 i t e ENCLOSURE 2 .'s. - r h 6 f U t' ' ' u$g. ..- l 4 Og.. ; e. N

• n

,a-4 . x.. n,':S a .A.

l P \\ I l I l Draft public dnnounI;ement NRC ISSUES POLICV .a EMENT ON REGULATION OF MEDIC #' aES OF RADIGIS0 TOPES The Nuclear Regulatory Comission has issued a statement of policy on the role of NRC in future regulation of the medical uses of radioisotopes. The policy is based on past regulatory experience, comments and advice of the public, the States and NRC's Advisory Committee on the Medical Uses of Radioisotopes, and is designed to guide the NRC in its regulation of the medical uses of radioisotopes. Under its provisions: The NRC will continue to regulate the medical uses of radio-1. isotopes as necessary to provide for the radiation safety of workers and the general public; The NRC will regulate the radiation safety of patients where 2. justified by the risk to patients and where voluntary standards, or com-pliance with these standards, are inadequate; The NRC will minimize intrusion into medical judgments affecting 3. patients and into other areas traditionally considered to be a part of the practice of medicine. e O A

P-Ma d,AM

p.. a T 4e as r aw-a-r-e

-wa-wmyam.. -wmm.,ma,m4.ps,miq_u-aaw m.u saae, g w.s me,,megya,u..a.m mm.e 4<, p g g e.,ys m,us,pqq mg,3 ggg .g,a 4 gg, m,, ,*k* 3. o -,' 4 .g '+ t e e a d B e 9 9 ENCLOSURE 3 O G O p a. t'W

l. *..y

. - {. +. y' y J e . t~ .1* 8 <. ,a s. ....; \\y,..s,. b = u,,."' lM -;s. s. m<

g., s

.,gvgv $,.- ; j' % t v a-* e.r.

s. A.,...... <. +.. v4L a.#;r. +. mu s pC..,*

--2 - z b,. g

ORAFT. CONGRESSIONAL LETTER Dear are Enclosed for the information of the copies of a Nuclear Regulatory Comission statement of policy regarding its It will be published in the regulation of the medical uses of radioisotopes. Federal Register. The policy statement was developed from past regulatory experience and the coments and advice of the public, the States and NRC's Advisory Committee The following principles will guide NRC in on the Medical Uses of Isotopes. its regulation of the medical uses of radioisotopes: The NRC will continue to regulate the medical uses of radioisotopes as 1. necessary to provide for the radiation safety of workers and the general public; The NRC will regulate radiation safety of patients where justified by 2. the risk to patients and where voluntary standards, or compliance with these standards, are inadequate; and The NRC will minimize intrusion into medical judgments affecting patients 3. and into other areas traditionally considered to be a part of the practice,., of medicine. Enclosed also are copies of a public announcement to be released by the 3

2. Draft Congressional Letter. - 2-i Comission on this matter in the next few days. Sincerely. - Robert B. Minogue, Director Office of Standards Development

Enclosures:

1. Policy Statement 2. Public Announcement J {t;,-

i \\ 5 7. ...s.,. e r 1 4 .g 2: :, .q j.4: 0 J... ; ' 4....f'.,. ,2 N .,. i,. H ?. H ? 1. ...... - 9. :.... .. = m. ..,.s.. q*.. s. <?.. .,t.. I. f,, cj,!.' l ,t -., )4 d. ' I S * ' :Q d. ','..,, ' s :,M. s s n :d.g.-'. * - ,.3 .~ t . o p... c. i.. ..? ;.,. v.M, A ;.;,; '. -l.e $..?.. T. * ' g.. (l' : ; s ..... v..n. ,J 6 8.f; g.... :g *,.s.H' . '../ 'i ' ,~ .s.. +.. g, ' g., r<.p.;. :.g. #. . u .4 4..,.... ..e..:y .g .m s.: -...,:.. y .t.n.

c.,r..,.

mr.

c 1.y s

.m.- ,3.s, .q... .p... Q a%Q s.:: - '.J;y' ' 3 ,~ ....,4 s. .< i.6,,-.

. -{.

,.. ~.. - y:*- r , g.g V.c.;

,4 '

...g.. f., ll,W.. [. ", ** y,D'e : .::n;. , ? J."t. 4.$ :( g. 8 Mf.. . ;; - y 3.;: . y _, S. /.4.... ;

• .'. d.

.Y. i. p, P5 j '.. 1,

4., l."

.. j E 7V .J [ ,j?.. '. - .r - 'A. }.- ..i*",. a.,. ,: 4~e t'., a**.

'. 3 c

.e ya ; ll.:i ?.s P ' 4 '( '. '.*lll, (}'. ~ 4

• 6 6 '

1. ?. l4 .I .g: * . \\ ',., h., .c v. [' '.l..ll; 8 ~., ". k ?- .r Is. .!k-l.,, %. ;,r :j g'v',. 'h 6

i.'

.. ; 7.. q. i. C, .py y n.,,. + 'kI/ ~. jp '-,, e, *.. o '..

s *

. h i /. . 3,%a f' , '. ..;. b.~ , he;.,.s,,m, e,:r. v.

m. - s

.W..- J t ':*.t J' .c l f 'f'.. i

, ' ^ ~

^ ?. e. 1.y%.g n;..' +. ;.. J.4.,,, ...o .,. s b..,% . I* :.. j. p, 5 p,.. 7,[ ,'.h 'I ":. Y. ' k - k-i ' !. e,..,.:. : 1:,. :<. ;..n ~ .... :... b u ' a., h...,.$. y h.:' 0 ?' cc. ~;'. '. : ',L.';.; ; L.' e.f:,,'h,.,] ~ e ~h :. .p

b. [ ",, ',...

;.,,.. d. f.

..c o, p ;....... r =. i' .,'s

• * )..

4

• }.C s

.,... f i.....,. _.s '.'?. '\\' } g f _ '; ll'.. e. y* ;. p - ~ ',s W. o 1_ I'

• L.#

e * -. .e.

• -,l**.

e' y,, 't 4,. e' .,= ~,- w n s. s l z_.. p

w Sumary of Pub aiients on Proposed '~ . al Policy Statement Walter Wol. Ph.D., Professor and' Director Radiopharmacy, John Stauffer 1. Pharmaceutical Sciences Center, University of California. Dr. Wolf makes three suggestions: FDA's Radioactive Drug Research Comittees' role in regulating the a. = use of radioactive drugs for research purposes should be spelled out in the Section 4. " Selection of Radioactive Drugs or Devices to be Used". NRC should recognize in its regulations the difference between b. hospital-based radiopharmacists' activities and larger nuclear pharmacies remote from the hospital. NRC should not lump paramedical personnel into a single broad c. categorywhereprofessionals(pharmacistsandphysicists)are combined with other individuals of a more technical and auxilliary background. Normand J. Michaud, B.S., Radiological Physicist, Assistant Professor o 2. Clinical Radiology for S.U.N.Y. at Stonybrook, New York. Mr. Michaud suggests the following definition of the qualifications of a Radiological Physicist: "An individual who devotes the majority of his time to the physics of radiology, including therapeutic radiological physics, diagnostic radiological physics, and medical nuclear physics and who may or may E' ' Enclosure 4 1 P

. ~ _ _ _ _ _._ _ __ _ _..,_, _. _, _ _ _ n"* oertified by a recognized specialty board."(CurrentProcedural ferminology, 3rd Ed., Published by the American Medical Association, I Sept.1975, Page li; i Mr. Michaud suggests that written in this manner, the definition does not exclude a segment of qualified profession fo'r many years. He i further suggests that written differently, a grandfather clause will j have to be mentioned in order to protect these individuals' human rights. Mr. Michaud also offered a definition of the calibration of diagnostic equipment that applies only to diagnostic x-ray units. 3. Ruth D. McPherson, Ventura, California. Ms. McPherson expressed satisfaction with NRC monitoring of the qualifications of practitioners. Michael S. Cunningham, B.S., R.T.N., Imaging Supervisor, Trinity 4. Lutheran Hospital. Mr. Cunningham believes that the medical policy statement and the specific issues were properly stated. However, he is concerned that enforcing the misadministration reporting requirement will be difficult. i } 2 tg h

G. D. Adams, Ph.D., Department of Radiological Sciences, Graduate 5. Studies Division, The University of Oklahoma Health Sciencies Center. Dr. Adams discussed the term radiological physicist and requests that i this particular subgroup of qualified experts be recognized in the medically-Dr. Adams oriented sphere of radiation safety and radiation measurements. states that measurements, most particularly where patients are involved, is a business for a trained professional. He believes that the radiological physicist is the only professional who is trained appropriately and who is cognizant of the ethical principles at play. Martin L. Pollock, RPH, Phannacist and Radiopharmacy Student, University 6. of Southern California, Los Angeles. Mr. Pollock supports the proposed rule change deleting the diagnostic clinical procedures from the group medical licenses. Mr. Pollock believes that NRC's role should be limited to the ra safety of the professional staff, the rest of the hospital staff and general He believes that patient dosimetry is a responsibility of the patients. Mr. Pollock feels that NRC should first individual institution and not NRC. require adequate staffing, including a board certified physician or radio-pharmacist and a radiation safety officer, and then essentially leave th facility alone regarding dosimetry, instrumentation, calibration, drug Any procurement or any other function considered the practice of medicine. 3

s0ch regulation, he feels, will impede the delivery of clinical r ' ag-t nostic services, will stifle research, and will raise heal *' ..re cos s. Mr. Pollock is totally opposed to NRC requiring' reports of misadministrations. Mr. Pollock al'so opposes NRC's stepping into the areas of educational and training requir'ments. He believes that the educational and training system e is handling its own. -7. James A. Hancock, Jr., Radiological Physics Consultant, Norfolk, Virginia. Mr. Hancock disagrees with the Commission's proposal not to take a stand on the training and qualification of technologists. He points 4 out that most of the work done with radionuclides is done by the tech-nologist, not the physician. He believes that the requirements for their competency is much more important than for the physician, in tha real world. Mr. Hancock also makes some suggestions pertaining to the-draft i medical licensing guide. 8. WilliamH. Briner, Captain,USPHS(Ret.),AssistantProfessorof Radiology, Duke University Medical Center, Durham, North Carolina; Consultant to the Nuclear Regulatory Connission. 4

i

f l

Mr. Briner questions NRC's authori' regulate: (1) patient safety, (2) the distribution of .spharmaceuticals by nuclear pharmacies l and (3) the qualificatione . paramedical personnel. i Mr. Briner states that NRC legislation fails to mention radiation i safety of patients, but does mention safety of the public. Mr. Briner l j believes that NRC cannot equate patients with the public and he further believes that patient safety is the exclusive concern of their physicians. Mr. Briner also believes that NRC is wrong to consider patients as users i l l of byproduct material. Mr. Briner believes that the dispensing of a prescription for a l j specific patient by a nuclear pharmacy should not be limited by NRC to He believes that l drugs having an effective FDA New Drug Application. dispensing is a professional act of a licensed pharmacist and that the i i whole body of Federal drug laws and regulations does not limit the l l physician-patient-pharmacist relationship. I i Finally, Mr. Briner believes that the qualifications of paramedical personnel can best be handled through licensing and credentialing processes i } by the states and the private sector. 5 u. t

i mi= >-s ui sis i is i 9. Willi-u ahd, M.D., President, The Society of Nuclear Medicine i), New York, New York. The SNM contends that NRC should not regulate the radiation safety of patients because the physician is always responsible for the safety of his patients and the responsibility cannot be shared. They characterize the NRC's proposal to regulate the safety of patients as arbitrary and ca-pricious and certainly not in the best interests of patients. The SNM cannot find anything in NRC's legislation to authorize such regulation and the SNM interprets this as Congress' intention to prohibit arbitrary controls over medical users. The SNM also disagrees unequivocally with the concept that patients are users of byproduct material. They feel that the patient is the recipient and the physician is the user. Tne SNM disagrees with NRC's proposed policy that would limit nuclear l pharmacies to distribution of products prepared from FDA radiopharmaceuticals or reagent kits. They believe this is an unwarranted intrusion into the practice of pharmacy. They emphasize that distribution is not the same as dispensing on the prescription of a physician. 6

With regard to qualification's'of paramedical personnel', the SNM believes this to be an area best left to the private sector. The SNM "... maintains a posture of opposition to the reporting of misadministrations to the NRC, or to any, other regulatory agency." W. Reed Johnson, Chairman, Professor of Nuclear Engineering, Radiation 10. Safety Committee, University of Virginia. Mr. Johnson asked if NRC accepted American Board of Radiology certification whether or not special competency certification in nuclear imaging procedures has been added. Mr. Johnson also asked some specific technical licensing questions regarding broad byproduct materials licenses. Mr. Johnson believes that the policy statement and regulation changes will go a long way towards eliminating apparent conflicts between NRC rules and regulations and the guidelines of the Food and Drug Administration. David D. Snellings, Jr., Director, Division of Radiological Health, 11. Bureau of Environmental Health Services, Arkansas Department of Health. The Division of Radiological Health and their Advisory Conunittee agree generally with the content of the three part proposed policy statement and 7

recommend that NRC pursue action to ' develop uniformity in"the regulation of naturally-occurring and accelerator produced radioactive materials. ' a tre The Division of Radiological Health believes thet NRC should u measurement of the patient dose with properly calibrated instrumentation. Otha W. Linton, Director of Governmental Relations, American College 12. of Radiology (ACR), Chevy Chase, Maryland. i The ACR salutes the third part of the proposed policy statement

However, relating to NRC avoiding undue intrusions into medical practice.

they are concerned about proposals that contradict that third part. Specifically, they cite the proposal for reporting misadministrations to patients and to NRC and other proposals that appear to them to be more restrictive than FDA regulations. The ACR suggests that it would not create any significant danger to the public to achieve agreements between NRC and FDA before publishing any further policies or regulations in areas shared by the two agencies. A. T. Tuma, M.D., Radiologist, Physicist, Popular Bluff Hospital, Inc., 13. Poplar Bluff, Missouri. Dr. Tuma welcomes regulations pennitting physicians more latitude when He adds that for therapeutic using low risk diagnostic radiophannaceuticals. 8 bn.

4 l 4 J purposes he prefers Radium and x-ray rather than Cesium and Cr' ' ucause j-i I, the former are less regulated. l l* Dr.' Tuma believes that evaluation of gaysician's clinical qualifications j; need not go beyond requiring an M.D. or D.0. degree, internship, and board II ll* f certification. l l Dr. Tuma coments on x-ray regulations, occupational exposure limits and 2 He also suggests that only those misadministrations having i ALARA guidelines. l demonstrable health effects on patients need reporting. Charles G. Overberger, Vice-President for Research, University of 14. i

Michigan, i

Mr. Overberger transmitted the comments of faculty members. 4 With one exception, the faculty members within the Division of Nuclear Medicine believe that the policy statement is reasonable and comprehensive. However, they cautioned about the possibility of an overzealous administrator I developing rules to implement the policy that would raise the cost of nuclear medicine services and increase malpractice litigation, without benefiting patient care and/or patient and staff safety. 9

1 I ad"about NRC's policy of licensing nuclear One comenter was co-pharmacies to die' ..ce only those products that they have prepared from FDA-approve',adiopharmaceuticals or reagent kits. He stated that nuclear phannacies supply researchers at other institutions diagnostic agents in radiochemical fann. Then the researchers may use these radiochemicals on humans under their own " Notice of Claimed Investigational Exemption for a New Drug" (IND) with the Food and Drug Adninistration. He believed that NRC's restrictions may result in a serious threat to the future development t of diagnostic radiophannaceuticals. Tyra T. Hutchens, M.D., President College of American Pathologists 15. (CAP), Washington, D.C. The CAP questions HRC's authority to regulate jn vitro diagnostics because section 81 of the Atomic Energy Act of 1954, as amended, mentions medical therapy specifically and not diagnostics". They also feel that the hazard from in, vitro diagnostics is so small that NRC should assess the n . benefits achieved by regulating them. On specific issues the CAP coments as follows: (1) Evaluation of Physician's Clinical Qualifications _ The CAP strongly believes that the NRC has no expertise in the area of judging " clinical competence." Such judgment of competence, they feel, properly belongs in the states in the form of medical licensure laws and to IEnclosure4 10 u

d the m ' .. staffs of individual,. institutions. They are opposed to the I ..c position of this issue. (2) Selection of Patients The CAP opposes NRC involvement in an area which must reside in the ~ domain of the physician and his medical judgment. They agree with the NRC not to limit a physician's discretion in the selection of patients other than that which already exists under the general medical license (10 CFR 35.31(c)(4). (3) Selection of Instruments The CAP believes the selection of instruments for performing diagnostic 1 J or therapeutic procedures is a matter of medical judgment. Further, the FDA through the Medical Device Law has adequate regulatory authority to control the standard of quality of such instruments. Therefore, they do not believe the NRC should expand its regulatory authority in tHs area. (4) Selection of Radioactive Drugs or Devices to be Used_ The CAP believes that it is unnecessary for the NRC to extend its regulatory authority to include the physician's use of medical devices con-taining radioactive material. (5) Selection of Procedures to be Performed The CAP believes that the physician's choice of clinical procedures is a matter of medical judgment, and that the NRC need not expand its regulatory authority in that area. 3 i 11

(6) Selection of Dose.l.evel. The CAP believes that the NRC should not regulate the physician's selection of the dose level of radioactive drugs, because this decision is a matter of medical judgment. (9) Qualifications of Paramedical Personnel Because several organizations are already developing or providing minimum standards, guidelines or certification for technical training, the CAP believes it unnecessary for the NRC to get involved in that regulatory activity. (10) Reporting of Misadministration of Radioactive Material or Radiation from Devices Incorporating Radioactive Material The CAP could support a provision on the reporting of the misadmin-istration of radioactive material if sufficient safeguards are included which would protect the integrity of the physician-patient relationship and protect the reporting individual from arbitrary litigation. John D. Watson, Jr., M.D., President, American College of Nuclear Medicine 16. (ACNM), Dallas, Texas. The ACNM commends the NRC on its realistic approach to the application of radionuclides for diagnostic nuclear medicine procedures. C. Duane Dauner, President, Missouri Hospital Association. 17. The Association supports the intent of the proposed policy statement but it is concerned that the NRC is considering the establishment of standards p 12 . Enclosure 4

. e' f for paramedical personnel. It Ofges the Comission to rily on st ~ ,,aern-ments and existing recognition programs, rather than dup 1' . Inese efforts which it believes are well-establishgd,and improvi-

18. Joseph 0. Ward, Chief, Radiologic Health Section, Department of Health, State of California - Health and Welfare Agency.

Mr. Ward concurs in the view that NRC must continue to regulate the medical use of radioisotopes as necessary to provide for the radiation safety of workers, patients and the general public. He fs also pleased to see the statement, "NRC will act to help ensure that radiation exposure to patients is as low as is reasonably achievable, consistenc with competent medical care and with minimal intrusion into medical judgment". He suggests that NRC, in consultation with the Agreement States, should develop a national program to implement this latter statement. Peter Wooton, President, American Association of Physicists in 19. Medicine (AAPM), Seattle, Washington. The AAPM is pleased that NRC and FDA are working to reduce overlapping They believe that diagnostic and therapeutic uses of radioisotopes rules. should be considered separately since the absorbed dose-benefit relationships have quite different goals. The AAPM is concerned that the limited definition of radioisotopes is not spelled out in the pclicy statement and, when taken out of the context .,Enclocure 4 13 \\

. l. -. x o M i of the footnote, it could be in+- . sed to include naturally occurring and accelerator produced rad' ..s copes. They also recomend that NRC's Advisory Comittee on the Medical Uses of Isotopes include an additional radiological physicist and radiotherapists. Ralph G. Robinson, M.D., Head Divis' ion of Nuclear Medicine, University 20. of Kansas Medical Center, Chairman FDA, Radiopharmaceuticals Drug Advisory Comittee. Dr. Robinson favors the proposed three part policy statement. Dr. Robinson believes that NRC's policy of licensing nuclear phamacies to distribute only those products that they have prepared from FDA-approved radiopharmaceuticals or reagent kits may be in conflict with FDA policy. Dr. Robinson states that FDA policy permits nuclear pharmacies to proceed until FDA has had an opportunity to draft guidelines that will define those operations of nuclear pharmacies that are considered to be manufacturing. = t Anna E. Wasserbach, Chairperson, N.Y. Federation for ' Safe Energy, 21. Saugerties, New York. \\?- Ib ' Enclosure 4 14 e 4

~ .uach is concerEe[tha't doctors read radisp'harmaceutical Ms. V-la' .9 with comprehension. Ms. Wasserbach feels that the patient should oe included in the choice of medication and the patient should be told all the known side effects. i 22. Ivor Fix, M.D., F.A.C.R. Chairman, Department of Radiotherapy, Mount Sinai Medical Center, Miami Beach, Florida. Dr. Fix coments that periodic calibratbn of all brachytherapy sources would probably add more unnecessary exposure to the workers than protect the patient. He believes that periodic leak testing is a better way to ensure that there is no loss of activity. Dr. Fix believes that NRC maintaining a register of misadministrations may help in recognizing their extent but suggests that it not be a catchall He does not believe that reporting misadministrations for trivial incidents. to anyone other than NRC should be left to the discretion of the licensee. Reporting to the patient or his representative could, he feels, conceivably interfere adversely with the future treatment of the patient.

<:. losure 4 Enc 15

~

4 4 4 a hWh. .Oe. v' I.

1. E" g, 4-

."g' un; sy,y.;.. r.,sgyg ;; ;,)y P .fe, s* *,. 6.

,

, ?;,,,;

v,.., e. t ;;s; n.,, a t s, p x <,.,. %eg . 4 8

l

.u...s.. : g .o ,4. :t... Y~ p,. r ' 4 S p 4 s 1- ..e..

• t gl L e

h 'E. . e, s. .s f{ e 4 ENC 1.0SURE 5 af 4. 5.- 2, \\ Pe-F e 'e O ~ n jn' .kr , ^ e> P s '(' t ... 9 P e =. ?- ,g> 9.. , e%F F.. g* '- 4,l.. .z 1,.

., e,.,.-

. e.., - /.- ( . +, '*!.)%:.N...,e *T 0.s

)..~...

fe',.

• w,

. ? i2 $.I t 'f ,,.,',,.;'*)G'f e . + 91. -

'l,1... a ':

'h ...t<,

• fr

~ Q, .; : :.o 'e',n',,:ff$jf ty q, h.,,: y', k ?, t' y

• *. ~ N k *
• ' ' 'N '.. Q,h',b.,:...

,,i W * +ld "' I. Y.H ' ^~. .9tjl(;'"*.~%.l;d,j,fy.).?;~g"% ~ +. .,s ',..a j '"6m. .ma ,g

e PROPCSED RIAIS

11208, Based on poet, espertence and.the.

For the Nuclear Regulatory Com-regulating the medical uses of radiol. anmmante and advice of the puhuc. sotopes and to provide 4 basis for pos. Sax rst J. Crnr, sible future rulemaktnr.The notice re-othat Federal agencies, the States ar - miselon. , Secretary of the Commtuton, quested comments on specific tsauas as NRC's Advisory Committee o* Medical Uses of Isotopee tb" foDors: CyR Doc. t6-7ts1 yued 3-16-78; ::48 aml To what artent should the protec-aton has developed " aving tion of the patient be censid'ered in poucy statement to a regula. [7590-01h NRC's'reguladon of the medical use of tion of the med' .4 of radioiso-byproduct material? Areas of possih!e tapes:' regulatory involvement by NRC in 1.The NT' ..d continue to resuista i [10 CPR Pad 35] t!GULAflON CF THE MEDtCAL U513 th:s area include:

• the mec". uses of rsdotsotopes sa

1. Evaluauon of phystefan's run'-*1 necessaaf to provide for the radiacon CF ItADIC15CTCPES G"*"h tiora8 safety of workers and the general

2. Selecuan of patienta for dMenna. puhuc.

Propose:8 Poucy swomeg tic or thermoedlic procedures.

2. na NRC wC1 regulate tne rad!-

A Nuc' ear Resulatory Com-

3. Seleccon of instrumeen to te suon astety of padents wherv justined by therisk te patients and where vol-

. need tn' performing <"arnantic or untary standards, or complisace with therspoutic procedures. ACI' ION: Advarcognotice of proposed

4. Selection of radtnarttve drugs or these standarde. are inadequate.

ru!==

• n?-

devices to be used. 3.The NRC win minimha intrusion SUMMART: ne Nuclear Regutarnry S. Se e t$on of p.winres to be per* Into modcal judgments affecting pa-Commininn (NRC) has under conald-

onned, tients and into other areas traditional.

erstion the tonowing proposed poucy ly c sidend to be a part of the prso-watament regardag NRC's future rule e cr i uce of snedicine. in regulating tha medical uses of ra* to be used, dioisotopea. This NRC poucy state.

7. Proper measurements of the does ZZ.RazroseaLa ment la Intended to inform NRC 11-the parianv roostves. -

Tite NRC and its prod-r the censees, other Federal and State agen*

8. Canhrstion of diagneetta equip-Atomfc Enerry Commiseton have rted des and the public'of the Couunia" ment and dose-measuring insttumen. !ated the medien2 uses of radictsotopes ston's geners! Ictention regardng the taton.

since 1946. AEC recognized that physf. regulation of the medical uses of ra-

9. Cuauf!cstions of paramedcal pet.

class han the primary.esponsibliity dotsotopes. It is expected that future sonnet. such as technotoc.sts, nurses. for the protection of their patients NRC activttles in the meccal area. rsd!ccharmacista and tsdfotogical and designed its regulations accordict. such as promulgation of new reguis-physicista, and

17. The physicians were nqu! red to be tions and deve1coment of cocceraum

10. Reporting to NRC. the patient Ucensed by the State, and their appt!.

relationships wita other Peders1 agen-and/or the patient's physician. misad, cable trsining and expertence were etes, wu! fonow this statement of NRC midstradon of radonct!re matertsJ or evaluated in consultation with the Ad. radation inn dettces incorporattng visory Committee on the Med!ca1 Uses policy. rsdosettre material. of Isotopes. This naulauon has been DE Comments sie due on or in addition to the FranAt. RactsTra gene ally oriented towstd assistics before May 16.197L notice and other public announce. quallfled physiciaca in discharting ADDP NTR Send comments and meats. NRC directly contacted score their responsibillttes to patients. How. suggestions to: Secretary of the Com-than 30 phyrtdan groups. profesalonal ever, regulation by AEC/NRC has at missiom U.S. Nuclear Regulatory sociedes. puhuc interest groups, and one thne. or another encompaned Federsi agendes. the 23 NRC. Agree-Commission. Washingtom D.C. 23555. ment States and several non. Agree.nearly every aspect of the dellvery of Attention: Docieting and Service radioisotope medical Services to pa-Brsach. Coptes of coccents tnay be scent States. ne meetings of NRC staff with the tients; ne broadest regulation oc. e::smined in the: Nuclear Regulatory public and the Aditsory Com:rJttee on curred between 1942 and 1915 snen Ccmmissica Public Coc.unent Room, Medical Uses of Isotopes vers held en the Food and Drug Admi:istrstion 1717 H Street NW., Washteston. D.C. (FDA) exempted from its requee-INFORMATION

• May 6.1977, in Silver Spring. Mary-1and. The meett.s recor1 was held ments for new drugs ill FOR r w.uu.ts CONTACE open for 70 days fouo etng the needng tsdopharmaceudes's resuhted by Mr. Edward Podolak. Office of Stant for the receipt of written comments.

dards Development. .U.S. Nuclear Over 90 people partidpated in the 'The NRC 11evoses radiotnotopes in it'.ree public meetino and 33 comments were casesoriest typroeuct. sourse sad roectat su. Regulatory Commissfot Washing. received for the record. Transertets of ctant masar a1. The Nac does not teru: ace tom D.C. 20555. 301-443-4910. the meetings and copies of the com-natursur occurr:ns or secelerstar credcced NrNAL INFORMATION: menta may be examined in the NRC radioisosapes. ne ser:s Drproduct matenal In 1978. NRC with a view to possible PubMe Document Room at 1717 H means ear redsonenee masanM texcept ape-etat mueseer ma:ertan rielded ta oe made m-changes, began reviewtng its regula-Stnet NW., Washington. D.C. dioactive by esposure.e 'ne r3xauen 1:za. tions revstdng the medekl uses of ra. L Paorossa Potse? STArant cent to the procues of ;reemns or uma d!otsotopes. oristnally promujrated by special sueleer matanal, ne inns socres the Atomic Ener77 Commissiott This NRC policy sta'ternent is in-matertal means it) urnatum. trionum or (AEC). On April 31. 1977. NRC pub. tended to inform.NRC Ucensees, other nas coe.ninssion tnereof. :n any stirnema or tished a meeting nottee tn the PmERAr-Pederal and State agendes and the enemicta forza, or '2) ores wroen contara or RzotsTzz (42 FR 20691), inviting the public of the Commission's genersi in. wetsat one.tweaueth of one percent to.05 pubile to comment on MRC s regula-tantion regarding the regulation of percent) er more of u) uratuum, tu) tho lum, or till) any comunnacon ttstreof. tions concerning c:edcal practices. the :cedlest uses of tsdictsotopea. t is Soures Insterial doce flot.nclude scectal su. The FDERAf. RsotST3x notice and re* expected that future NRC acitivttes in lated pub 1c announcements stated the medical stes. such as promuits. f,,g,$%m ~ n.'

3. -

that the purpose of the pubtle mect-tion of new regulations and develop-eastesed ts the *.sotope 133 or in the uotose ings was to receive written and oral c:ent of cooperat:ve relat!cnships with 135, or (2) any matensi stuftetsur ect er:ed comments that the Cammission could other Federsl agencies, wtil tonow th's 3r snr of trte foretome sus does set m. use in deciding future NRC polley in statement of NRC policy, ciude sourco matenst. i i $ ^ - - ' - " - - w,--,--

l e p um mwoseas l g. AEC. Dartns this period AEC regula!- NRC's regulation of the n Mm1 use of an average dose rate frees s Atocharmaceutacals of 1 mrom/reer ed the radLacon safety of worten and byproduct matertair and an avsrate dose rate front diae. the senersi pubue sui the safety and Prom the'atandpoint of actM etncser of radioactive drugs and de. la clese that NRC can r ce nostic radiology of 'f2 mresn/ year in vices with respect to pacenta. AEC medical uses of byproe .ertal to 1970. retuistion included production of the protect the health r ..sy of users The fonowtng quotation is from the radictsotope. tammifacture of the final of this raeartat. f m:e. Dadenta. NAS-BEDL report-rsdlosettte drug product or device, dis In Ucenstng 11' session and use of In the faresseshle future. the major con-bih tributton, use sLd disposal of the prod. byproduct

• m.rtal. NRC esta l s es trau*

ucts. In 1975, the FDA terminated the limits withm which physicians exer. at on wm unw etse professional discretion. Frmn the M 'run an a w e w done of esemption for radlopharmaceutiesis, standpolst of policy, these limita snout tot suruun/reer, and amouncal applico. stating that it would now regulate the depend upon how NRC views the po-uses wtdata new enoueuse cosnoertWe es. safety and ettcacy of rad!oact;y, tantial hamrd to the padant's health pomarus te vertses tausmas et the teatr. 3 dads-drugs with respect, to padents. (As and safety in the uses of the byprod-ena w are nos ander ammared er said-noted later in this statement. 'DA act material. The greater the potential anoe tar resalanen et last as premana. t2ne does not resuiste the physician's ruu. hasar11 to a panent fmen the byprod. m et nanung restiassam to snedactas la et ttnat cas of rsdlopharmaceuticals.J Ag uct matertal or fta use by a pWan-tr====d=== velas bus as is emmasant w the same 12me. NBC withdrew from the more NRC may elect to ctrtum. roeues esposures sinos tids ena be accoms-regulating radioactive drus'anlety and Wh amas mat m!sht ocarwise be p wnhost less of beneas and as e N W eut. Mw ans is at onW to efEcacy, stating that it would resdate atarded as within me discredon of reduce the radiation exposure to the took tbe r=anm.n safety of the worten the physician, runal hus also to haw procedures carried and the pubMe. The 1976 Med!ca! The 11rst part of NRC's policy st8t a. on with seassunant m4=rr se taas there, Device Amendments to the Food. Drug Inent tchr** that NRC win cnntmos

• csa ce a comunutng incronas in w=ef and Cosmetic act extended FDA's an. to regulate the toedical uses of m11o.

im.cta --pm by a saanampas rudb thority over medical devices (including isotopes as necessary to p.4 Tide for scoo crpomsre. devices coMafnfar radfoactive matert. als) in s. way emf?ar to its authority the r=MaH=t safe,ty of wor %=.rs and JP C wC1 act to help ensure that rs-over dmas. the genen1 p He. dirt;Jon exposure to pattenta is as low NRC's authority to regulate domes-This is the traditfocal regulater-as is reasonably achievahte. consistent t:cany the =edcal

• ses of byproduct function of NRC for att uses of by.

with competent tuedleal care and with =aterial is found b the AtcmIc product. source and special nuclear m.al intrusion bto taeded judg. Energy Act of 1954, as amended. For matertaL It is a regulatory rote that ments. NRC wtIl not exercise retu!s-example, section 81 of that Act autho. was not questioned by any of the com-tory control in those mas where. rtzes NRC **:o issue general or specino menters bur. rather.11 was ennsistent-upon W mbada it deter-ucesses to apptjeanta seeking to use ir recosnized as a necessary role in the mina mat the an adequate nruis-medcal uses of radioisotopes. tions by other Fedent or State asen. brproduct m.a.terial for * *

• medical NRC's reguladon of the rad!ation etes or een administend professional thersor * *. Section 81 directs NRC to regulate the mactfacture produo. safety of workers and the ' reneral standards. Wherster posalble. NRC tion. transfer, rece!st in interstate pubuc h the medesi uses of radioiso-win work c!ceely with Feden1 and commeree, acquis1Uon ownerahlp. pas. topes la rettsquished by NRC to Agree. State agendes and E# feestond grows -

session. Import and export. of byprod-meet States: does not overlap with in d@mr new voluntan sindance uct material. Mnally. Seedon 81 also FDA's acttftttes: is in harmony with for pneddoners to Urnit unnecessan regulat. ton by the Department of patleut' radiation exposure. However. directs that: Tnnsportanon. Sodal Security Ad-the are specif!c anas d!acussed in The em-mon shan not permit ite dis-ministration and the Jotnt Commis, Section III of this poucy statement

1. 1. " " "#""# D#8" " * ****^*I " '"#

sics on Attred!tarfon of Horpf tals: and shere NRC wC1 regulate the radiation - oYdis dovetails with Cccupational Safety safery of patlants to help mb Nf** un. al co sor and Health Admtchcration regulation ee. vno 14 not equ:pped to ot4erre or fara to of the wort. place for the use of natu. cecessary patfect es Ocaure. The third part.cf NRCs poucy state. ot: serve roca aatet7 naccarts to statect health sa mar t>e estatushed nr the coes. rally.occurr:nr and accelerator pro. ruent ind! cates that NRC wt!! mini. suasion or who uses suen matertalin rtota. duced raccac:fre W=e m!ze its tntrusion into ruedeal judg. non of Law or revulation of the Commtas'.an The second part of NRCs poucy ments affecting the patient and into or :n a macaer osner taan sa hw tn ,gge,m,nt tndcates that NdC win res. other areas traditionally considered to Q*88Lemuco thanfw or accrmd by the ulate the radiation safety of patients be a part of the practice of medicine. whers jmMad by the rish to padents The Commission recogn!zes that phy-Commiaston restlations. for the and whers vehmtary sundarda, or most part set forth in 10 CFit Parts 30 ccmollance with these standards, are sicians have the primary respoumbiuty through 36 wers promutsated to carry inadequ.ste. As noted befort. NRC has for the protection of their pauents. out the broad regulatory sche:ne en. the authority to resulate the r=Mattan The C==W believes that basic decisions concerning the <"W_* And visaged by section 81. For example, safety of patients. Part 35 establishes regulations specirlo The NAS-EUR* report discusses' treatment of disease are a part of the physictan-patient relationship and are to human uses of byproduct material. It=1 ting the exposun of the popula, trad!donally considered to be a part of FDA's statutory authority (Feden! tion to medcal appucadons of lonizing the praedce of med!ctne. NRC regula-Food. Drug and Cosmetic Act, s.s radf aMon. That report, which includes tions are predicated on the assumption amended. 21 U.S.C. 301 et seq.) does all moment uses of M*F radiation, that property trained and adequately not am%h NRCs authority. Where informed physic!1ns will tnike dect. NRCs and FDA's authorttles ovirisp. th 85 8 stons tn the best interest.cf the'tr pe,. the respective autherttles enn be har.,[, y*""M%u e a tients. mont:ed by intengency agreement. Osch Madams of Scenens Adnaery The reluisttots try to fbd a balance The cent al question in the April 21 137't. Pznsaar. Rrctzrra notice ts a Q f $ between adequate controls and avold. ance of undue interference in = eden!. question of policy not author.ty* ymca os Pmtaum of moeure a w Judgmenta.< A consequence of too ENIT: Imis of tonmns Radacco. Nauocal Mad. To what extent should the protec* ems of Scancio-National Researca coun. much regulation could be poorer tion et the patient be considered in c:2. Wan.mrton. D c. 131n health care delfvery to patients. A con. ~ M011M t.ICt!?tR. YCt. 42, NO. 53 JttDAy, MARO417,1773 ~ --~

l j .e. s g E s autIS 8 1 11210 qu!rement is that the physician's MMstrations of radioac. training include " supervised enmtpa, s t' S sequence of leaving to physicians the material to be exclusively the Uon of patients to determine the suit-majodty of the decisions concernin' .n actice of medicine or a part of physt. Ability for radioisotope diagnosts and their padents Is that the physF cian. patient reistionships. As de. recommendation on dosage to be pre. will make mistakes. The t!gP schbed in deta11 in Section III. the scribed." lation of phystelans' deck . fed. eraJ. State and profes.' oups will Commiulon intends to rvsulate these The Commission recognizes that the areas of patient radiation safety where selection of padents for dbanostic or not be able to pret' .ure incidents Just111ed by the rist to patients and therspeutic procedures is basicany a in the med! cal t" a radoisotopes. The Cemr on recognizes that where voluntary standards. or compu. matter of medical judgment. DLssnos-FDA regulates the manufacture and ance with these s'andards, are inad, tic procedures have a low pattent risk sad therapeutic procedures are spe. interstate cat.ibution of drcss.includ. equate. .cialtsed and patient specific. Radioac.. ing those tant are radioactive. FDA III.NRC Poaznos on Srsczytc Iisers 22ve drug manufacturers ptwytde guid-abo resulates the investfradonal and ance on patient selection and enntrala, rosestch uses of dmss as weil as the. The fonowing. represent the Com* specinc Widance on doses andN mission's p sition on the specine dientfans in the product labeling. Sup. guidennes on plemental voluntary dures foun't in the product' labeEng, 1ssues rstaed in the April 21. im. Frp. !!miung padent radation esposure. in-However. FDA does not have the au-saar. Esczsm announcanent M FR cluding the standpoint of paUent se. thority to restrict the routine use of 2m1M ecWA. aM avaHable in U38 hrstuM. drugs to procedures s' described in the J. svaaVAnoN oF rWYsterANs' ct.tylcAI. tient exposure from improper selee. product labeling) FDA has approved QUAf.tTrCArroNs Uon of patients is be!!eved to be emaft as safe and effective. Indeed. NRC !s the only Federal Agency that is cur. NRC has always required that u. Therefore the Commission does not

• ently authortzed to resulate the rou. censees be qualified by trafning and anticipate the md to lhnft to any time use of radioactive drugs front the esperience in the handling of radioso, major extent, the physician's discre.

standpoint of reducing.uzmacessary rs, tive material from the standpoint of tion in seleceu of padents. Because distion exposure to patients. radiation safety of workets and the the NRC does not evaluate physician The CommMen believes that the gener 1pubite. qualifiesticas for the geners! !! cense, the Commission win continue its dagnostic use of radioactive drugs (s. The Commfulon beueves that it is in most cases, clearly an area of low necessa.ry to continue to era!uate phy. minor nstricton in the general med. radiadon rtst to padents. Therefore. s1cians' etM'est quall!!cadons prict to est license (10 CFR 35.31(cMil pro. hibiting administrations of rado. NRC wt11 not control physician's pre. isruance of NRC Ucenses. At this time rotatives on patient select!an. instru. there is no alternative taethod of de. pharmaceuticals to a wotaan with con. ment selection, procedure sdection. termining if a physictan not certif[ed finned pregnancy or to persons under drug selection and dose level for most by the American Board of Nuclear 18 years of att Ms nstMcWn does diagnostic uses of rad!alsotopes. For Medfeine or the American Board of Isot affect synice Ucensees, au therapeutic uses of radcactive Radiology, is competent.to use byprod.

s. stz.tenow or IssTzmacers to as drugs. and in certairr d! agnostic uses-uct, material. However, the Commis.

esta IN rsaroaxxxu stacMosTre on for eatmple, the use of phosphorus 32 sion also believes that, as this celd of Taxmarsene inocrotnuts. for locali:stion of eye tumors-the medfcine condnues to mature, other risk to patienta is not Iow. The risk of alternautes will replace the NRC eral. NRC evaluation of a physician'a t!,ssue or orgin daman. (or even death) nation of ettnfest quanncat: ens. quallflcations includes an evaluation is inherent in the use of therapeutic NRC has for several years accept 4d of training in radiation phystes and in. levels of radioactive drugs. NRC will' certincation by the American Board of strumentation. continue to restrict the uses of thers. Nuclear Medetne and the American The selection of (nattuments for per. peutic and certain diagnostic radosc. Board of Radology as suincient evt. fonning dasnosde or therapeude om UI' P'U'"' 8'I#'*I'8' D"#I* tive drugs to the indicated procedures dence of clirdeal ecmpetence In the d"818'atter of medcal Jud._o.en. that have been approved by FDA. The fields of nuclear med!*tse and rad!. cany a sn NRC will not control the phystefans' adon therspy, respectively. It has re. b on e select c bra o prerogatives on padent selection and cently determined that certificadon by instrument selection for therapy pro, tae American Board of Radiology in and maihtenance of instrumentaden, cedures, because these procedures are Diagncst!c Radlology, with Specfal Again diagnostic procedures have low so spedalized and patient speciUc. Competence in Nuclear Radology, is padent risk and therspeude proce. Congress recendy gave FDA author

• sufUclent evidence of clinical compe. dures are speciait:ed and patient spe.

ity to regulate medcal dettees, simuar tence in nuclear imaging procedures. ctSc. NRC does not currendy restrict selection of instruments and does not to FDA's authority to reguiste druss. Based on specific assessments in con

• anticipate the need for doing so in the but with additional authority to re. sultation with its Advisory Committe*

strict the routine use of med! cal de. on the Medcal Uses of Isotopes. NRC future. The Commlufen recognizes ~ that FDA will regn:ste the invesura. vices as may be necessary to provide win continue to expand !tJ use of the ttonal and researca uses of medesi de. reasonable tasunnee of their safetyand effectiveness. FDA has not yee. various board certifications as sa tory evidence of adequate cunical Medical Devies Amendments of 1976 had suffleient time to implement its training and experience for the medi. full authority to regulata medcal de. cal uses or radetsotopes. NRC w13 (Pub. I. 94-395). The CommMon also these amendments racostuses that vtces containing byproduct, source or also work closely with the professf a+tl sive FDA new authority to restrict the rpecial nuclear materfsl. Therefore, societies to aseist them fn develcNg routine use of meccal devices under NRC wiu continue to restrict physj. suitable permanent alternativer to such condtlons u may be necessar7 to cian's uses of these snedical devices. NRC's evaluation of physicians' cilni. provide res.sonable auurance of their both for diagnosis and therapy. to ca! quallacations. safety and effecuteness. those procedures that NRC has detar. tnined (In consultation -tith its Adviso.

2. smemn or mas m o smems or aan.orem :necs on ry Committee on the Medcal Uses of stacsosnc ca n2xArum meterats

" C*8 " **

• Isotopes) to be safe and effective.

NRC currently evaluates a physt. The NRC now restricts a physician's The Cornmissien does not consider cian's c!!nical quallf! cat!cas to use ra. select:en of radoscuve drugs or !!=:t. equipment calibration, qualillessions doisotopes on hen" One NRC re. ~ of paramedeal personnel or reporting i* ftD11At 150t$TIA, VCt. 43. NC. $3-#tt0AY, MAAcH ly,1978 Enclosur 5

o e IIZ11 PtcrosED RtAs tr matition of the tsdioact!re cedures for vtdch there is substantial labeling. NRC regulations are mare 79-w those products meeting FDJt. erMmen of safety and effectivenees.. strictive than FDAres"lariaan .,J1remsnta. The physician is thus that is. to those pihlw approved Elsewhere in this-tssue of the Frass. restected to using radioactive drugt in the drug tah*Hnr According to ar. Rearrrsa is a proposed rule that subject to an FD A. approved " Notice of FDA's statenant on drug tuhattnr would delete the sDaM~"? Of the. rHnfest procedure from the lists of the e CIAltned Invest!sational Exemption m ygg f.*=h cleady neoem Me W b for s.New Drug'* (DfD) or an FDA.ap* that the labeung of a maneted drug does WW. However, this proposed rule 1 23.100 proved "New Drug Appucation" not arways contam an the mosseurnut to. would place Itmttadons on a drug's use (NDA3. NRC regulates the manufao. formacon avanable to particsans reisting to ture and !=stdlatics of telethetspy the proper use of the drus in rood medical for prcedures not specicled in the dertces as well as the intesTity testing prscuce. Advances in medk:al knowledge package insert. of these and other radioactive medied and practice tnert+abir precede labeans re. A.: noted in Section II of this policy ciertces durtng use. However. NRC etaten by the manufacturer and formal 1a. statement, the radiation risk' to the banns sponreat by the Food anst Das a patient frons most dtagetic nuc! ass - does not now nquire that medical de- "*d'i"' AA*" I" I# 'UII' "D* vtces enntatntna radioactrve material ""jl % and W 6 FI'" I" 'i'"'"#*"I I" "I'" meet FDA requirementr-estethus requtre sbas m be noe to therspectaclevela of radAcacthe drugs The Commisstats beneves that it is use drums ammannns to thetr best knowtedse 'fha* few stiasnostio.pcocedures, necessary to continue its, restr4rden east W curtaatty. wties a paretcme where thn risk to the padens is high on the armaaNtitv of rutnarttte druss nees a dras fer a oss nec ta the span =4 ta. to those that, meet FDA tequtrrments, baung, he has em to be won. are not listed in E 33.100 but are the ' NRC will snuir and

2=*=

vfth FDA inrarmed about the enig and te base suca subMet.cf specino licenae autbcdza, one on nrna adenans r=nda or sound tions and will continue to hare the the necessity for e simnar NRC re. quirement ior radfonctive medical de-8"****I id**'f the drugs use and affecta. 'M" tent procedure speciced.

• • d**'""""Sd***"*

mascat records o , gee,,, tma such unnes to the pracuee of medietne is

s. sztsc-row or nosz tzvxn (ouarrTIrr f the Fmient Food. Drus or sacroacTzvs cartazar.on nunztnr Mb a

rad eda " 8E8" proved by FDA for the same proce. ceases to m'NRC !ssues two types of U.As noted in ftesn 1 adecdon d ps. "i#*"' dure. the %mmW does not plan to r edcal institutions for the tient.s. the physician's training must restrict a physician's decision regard-human uses of byproduct material, the indude supentsd expedence in ne. Ing which agent to use. The Commis. mexiled ucense of broad scope and the ' ommendisc proper dosages for speciI!c ston considers the be. sic decision on medcal ueense of limited scope. patients. drug or device selection to be a trad1 Broad medcal licenses authorize The. Can mMon 6 the se-Cfonal part of medical p medce. multiple quantides* and types of by. lection of dose level is harlem!!v a The Food. Drug and Comnetic Act differentiates between pharmacy and produca matertd for t.nspecified tues matter of medical judgment. The ami are Issued to institudens that (1) pachage inserts for ndioscure drugs manufacture. IIowever. no clean une have had previous expertence operat-in,f nda the recommended usual dose has been ertablfshed to determine ing under s. HmN meder.1 Ucense and usual dosage range. Because of when a, nuclear pharmacy has gone and (2) are engaged in medical re-the mant vartables that determtne the beyond the ort 11 nary practice of phar. search sa well as routine diagnosis and most effective dosage for both the di. macy (compounding and dispensing) and has barema s. manufacturer. The. therapy.uaing tsdioisotopes. The pro" agnostic and therspeutic use of radlot. FDA is dr2fting guidelines that will' sums under the broad medica 111 cense sotopes. the NRC does not now resu-define til of those operations (of nts. operate under the supervision of a late. nor doea it saticipate the naemb medical Isotopes em -etee No phys 1* ty of restricting in the future, the phy-a dear pharmacies) connected.rf th the clans are namad sa tedividual tuen on ageina s selection of dose level. preparation of rsdioactive drugs which the 1! cense, nor are radioisotopes L mit. win be ressided as manufacture (and, ed to specif!c clinical procedures. T. Faom N or m Dosz therefore, subject to FDA new drug re-Ilmited medics! licenses speetty the m mim iscznts quintnants) and not part of We-pruc. rad:cisotopes and the e4nW proce-The Cornmittion bei!eres that tice of pharmacy. In the absence of dures that may be performed by phy. Proper measurement of the radioac. FDA g/,fdelines, the NRC Ucenses gu. sfC'ans named on the Ucense. Under trre drug dosage or rS#Stfan dose in C!est phsstnacies to distnbute only limited medcal Licenses the institu. the case of therspy, helpe to ensure those products that.they have pre, cnal licensee.must.have.s medical that%e padent receMes what the pared from FDA approve <t radio. phar. !"sotopes -nWe nnd the physicians physician has pitscribed and thus macentients or ttagens kits. . camed on the institudon's Ucense con. helpe mWh unnecessary rsdiation

s. szLzerton or ritocrorats ;o st duct their pregisms with the approvs1 exposure to patients. NRC now re.

rzarcascrn of that committee. Under umited quina most h parucularly ca cense e suen ed dag. those who prepant radioactive drugs NRC evaluates a phyttetan's clinical nse and menpeute ndloscute frotn radioisotope renarstars or ren-qniffficadona. His training includes U 8 gent kits to mamme the dosage prior studes tmder a preceptor, of case his. to *Wattstica.This requirement is tories to establish the most approprt* UU CPR I. ses of b7 product tion. NRC wtIl study the merits of ule A'"" now. imposed through a license cond!- sta diagnosce or therapeutic proce, .me cal duna. Umitadons. contratndicadons. lts regniattans to requin d to th. 8 YW measumment of all ma-tic and = C mwon recognizes that the th pharma-selectica of procedures is ban es!!v & by PD in t Eug 1 k. aE[ d matter of-mediesi judgment. The Since FDA does not restrict the physi. ~ Commtsaion does not s.nticipate the cian to cunical procedures listed in the 'The risa to a parlens tma a f also comS need to umit, to any teajor estent, the e a false nasam Me thmush me physician's discretion In the selection

• Radisact:ve materials La i33.100 are di.

use of a drug for a purocae not tulir investi. d mn iprocea m vided into nz srousa, eacn sroup having sued and roecif!ed on tae tabel would be The Cerntnisalon recogni. es that

m. car req e-'nts ter caer trucms and expated *o te srester than it is for a ta.

FDA does not restrim the roudne use expertence. f acuJttes and emupment. and rs. beled use but th2s r*.at La di.tticuts to quanti. of NDA. approved drugs to those ;ro-d stacu saf ety procedarts, ff.

• penas a t ikGtSTilt. Vo&. A3 NC. S-MIDAY, M.asOt'17,17r1

l o . V' $ o s PROFQHD W115 11212 State. Federal and prtfate agencies in-any other drug of phy*'ena in any I other field of medicine, NRC currently has under consider. cluding: the Haalth Services Admin!s. The purpose of a mlWministration ation a proposed rule (42 FR 23743) tnuon (Medican and Medfeafd reporting requirement is to anow NRC that would requin annual caMbradon DIIEW). the Burean of Radioloccal to investigate the lucident, evaluate and monthly checks of teletherapy Health (FD A/DHIW). the Joint Com-the corrective actioti taken by the 11 units. This rule has received many minion on Accreditation of Hospitals ceasee to mtntmW the chance for re-pubuc commentat the comments will (JCAH). the Amertean Registry of Ra-currence, and, if oth tr Ucensees ce' be s.nalyzed and the rule modu!ed, if diological Technologists (ARRT). the make the same errors. been e warnnted. Based on the disposition of this proposed rule on teletherapy etM-Reg'stry of Medical Technologists corrective action wnich we' 6: a (RMT) and the new certifleat!on min! mum inform other lu.a. sees of bration. NRC may propose a similar boa.rd by the Technologists Section of the potential probtzm. rule for the periodic calibration of bra-the Society of Nuclear Medicine. As also noted in item 9, in the near - chytherapy sources, The Commtutnn siso recognizes that future NRC plans to publish. tn the

s.,.g m,,on or mAczome the majority of paramedical (alued yrnmt. R2cuna a new proposed rule 8088 "*

• health) personnel using rad!cactive for m'm+mMhtration reporting. The
  • "m"za'ra220s.."

material are not covered by these pro-new NRC proposal wt11 addresc (1) the, ma grams. Rather they are trained on-types of @A=Wstrations to be re. The Commtnion beneves that the the-job. are not certif!edt and many do ported. (2) the substance and tishs of caHbration of diagnostic equ!cment ~ not havet their trainLng documented. the reports. and (3) the recipients of sad dosage mesauring dettees helps However, the btroduction of a reis-nWa*Mhtration reporta, for exam-ensure that the patient receives what tively !csa comprehensive NRC. pro. ple, the referring physician and possi-gram, such as that in the 1973 AEC bir the patient or a responsible reina the physician prescribes and thus helps mintmha unnemurf radiation proposal, could underm!ne the efforts tive. as well aa NRC. exposure to patients. NRC presently of voluntary orgumf.s or those requires Ucensees who prepare radio-Federal or State agencies relying on I7. PUsuc m Anytsour Concarrzz. active drugs from radioisotope gener. more comprehenstre guldendes. Conomrs stars and reagent kits to describe 6 In the near future. NRC wtll pubush The NRC staff met with the pubife th$brauon og EIIcations a method for eur. Rzctsnx annouceement 7 and substituting an NRC propod M[g33M/fdMd%f d Ucense ap witpd.rawas sne e m an.su w m e.u. term an,mun ca vices. NRC also provides an acceptable Medical Uses of isotopes La an after. method for eatbrating dose cautra,

• • "'nktration repor*.!ng require.

noon public meeting on the same day. tors in "A Guide for Preparation of ment. That future announcement w13 The members of the Advisory Com. Apollcatlocs for Medical Programs" discuss more thoruushly the reasons mittee were the chairman. Mr. Rich. (NUREG4338 Rev.1 November igm for withd.rawal of the AEC proposal ard E. Cunningham. Deputy Director that can be obtained by wrtting to the and substitution of the NRC proposal. of the Division of Fuel Cycle and MS-Radio!sotopes L!cenair.g Branch. Dirt. NRC ts studytes the various allied tertal Sa'ety of NRC's Offlee of Nucle-sten of Fuel Cycle and Material health cert!I! cation programs cu mt* at Material Saf ety and Safeguards: Dr. Safety. Nuclest Regulator 7 Commm ly in effect or being drafted by other James Qufan from Northwestern Me-Federal. State and professional sfon. Wathin rton D.C. 20543. morial Hospitat Dr. Joseph Worrmari NRC presently does not have any re. Empsi If the coverage provided by from Duke Cnfrersity Medical Centert quirements concernts the caUbration these programs is not adequate to pro

• Dr. David Kuhl from the University of of d! agnostic equfpment. Because of tect the padent frocs unnee*ssary rk Call'ornia 14s Angeles: Dr. Renry the eatensive expertence of FDA's diation exposure. NRC will work, with Bureau of Radiological Health and the these groups to develop a new NRC Wagner from John Hot Is.:Utution: Dr. Ed eard Webster from

( new authority of FDA's Bureau cf proposed rule for the train 6s of anled wurhusetts General Hospital: and Medleal Dettees. NRC win conaborate healb personnel Dr. Frank De!. sad from the University 31th them in their derefopment of vol. "" of Kantucky.Two consultants to NRC. untary guldeuses for the routine CMI-I '* ** ** U # Captain WI1 Ham Brber from Duke O' **3I0^#U" " ***I 0* At bradon of dicostic equipment. Hospital and Dr. Peter the same time. NRC mil study the am raox pmers mec' aronam .UniversityMand frecrthe-M. D.-Anderson Hos . merits of preposing ca.ndatory.re,- -sAoroac;2Tg MAT alai.

• = - -

pital, also attended.The Comments from quirementa. As describe in Item 9 in.1973 AIC pur.[dthed a proposed rule that would pubtle can De Clusifled DrO&dly !n two

e. Qo A1.Z7fCATIoW5 of ra.1AMED1 Car., r13e SCC 3 As McDo!oCUTs. require UCensees to report MLW'Mh Categorie.a. In the first categor7. the trations of radiopharmaceu'.'Cals or r>

physicians, physictans' 370Vps phar. som:. NVRsts. RADIormmelSTs AND AAMO-diacon from byproduct material to macists' groups and industry com. range from statements that WCICAI' NIC8T8 the Ccmm!rMon ud to the pa:. tent or ments On March 9.1913. AIC pub!Labed a responsible rotative whenever the "present regulauena are tuttletent" to (28 FR 6333) a proposed amendment f"*ttration could cause a "de-the "the NRC should not regulate the to H. regulations in 10 CFR Part 33 mot.strably adverse effect on the pb use of radio!.sotopes in medicine at deftc.e the activ!!!es t!ent." Ninety.etsht comment letters all" Many of the comments in this that *would (1) that may be delegated by physicians were received. most objecting to the category stated that FDA regula*es and those that may not. (2) requirs proposal for reporting to the patient. the safety and efficacy of drugs and f physicians to determ!ne that para. Reasons given fcr objection to the re-that NRC should withdraw from th:s med! cal personnel have been properly quiremeos for reporting '"AmMu area and regulate only the radiation i trained, and (3) require tnedicallicens. trations to the patient were* (1) such safety of worters and the general ces to report to the Commfufen and to reports would constitute selfdacrtml. public. the patient rnisu"-etrations of ra. nat!cn. (2) such reports would invite In the second eategor7. NRC Agree-or tneresse unwarranted tnalpract!ce ment and non Agreement State rad!- dioactive material, The Com=!ssion reectn!2es that atton control s.gencies' comments suits. (3) this could place the yovern. there are several organizations cur. ment as a third paa.y in the physician-range from state =ents that "present regulations tre suff!cient" to "much patient relationship. (4) this is a rently involved in developing or pro. stronger -egulation is necessary." Mding minimum standards. guideuces matter of medical etafes. and (5) there or certification Icr technician training. are no comparable requirements !cr 3 These programs ars nNutered by 7spg1AL 11CtsTT1. YCt. a3. No.13-IRID AY. MAsCA 1r; 1975

• Enclosure S

. ll + e = , 'M . PtoPosID AU125 ' J atanv of the comments in this estego. should not restrict the physician to requirements. The

4. radio-rr note that FDA does not regulate those dispostic procedures that have pharmacist av usist groups the routine uses of drugs and devices been approved by FDA In the labeuns est partiev'

. nst NRC granting and, therefore. NRC abould regulate One member

• believes that 'NRC. credetW paramedics 1 personnel to ensure that the patient la protected should continue this restricdon or citt stumerous certifiestions and from unner*= mary radiadon exposure.* that some arrangement should be s of other Federal and State In the area of NRC's evaluadon of a made <f mita" to the in-house instite nMan. as well as etatming ladt of physician'a cunical quanficadons, both-tion committee resfew under an
• NRC authority 'to regulate in this estesortes of commenters recommend Broad Medical f fearsa area. The physician groups cite the greater use by NRC of board certifica.

Regsttifis proper menstr. it of fear that the number of certifled tech-uona. Physicians and the industry in the dcae the patient .ives, the cologists will fa!! far abort of the need I general appear to be interested. In States urge NRC to ewand the pre-for these personnel. maintaintng NRC evaluatica na a sent ifeensing requirement for men. The sense of the Advisory Commft. mesna of entry into the fleid, ney surement of doses of radioactive drugs tee is that existing ceremearf ans cover, feel that if NRC withdrew from evals. prepared freut rad!anuc11de gener-paramaht q=Imenthma and-hospi-tuns phra!cian's et f n te=1 qualmen-ators, to cover a3 doses of radfonctive tala loolr rsther caratuny at these. tions, the institutions or States would drugs regardless of how they are pro-They feel that. In the !!nal analyuss. require specialty board certifientinn-pared. On the related question of the physicians are responsible for their pa-They state that there are not enough canhradon of diagnoetto equipment tients and, therefore, are responsible board certifled physicians to f!H the and dose measurtcs icatrumentation, for the qualificat!ons of partmedical demand for services and.that board the States favor NRC activity aimed at personnel working under their dino-certification is not nemmary for many limiting ps!.lents exposures but recom-tion in caring for patients. With the of the radjolsotope procedures. The mend that NRC coordinate its activt. exception of physicist's 4"*'m'*** State twfurfen control. agencies be, ties with FDA*a Bureau of Radiolog!< for caubration of rsd!ation therapy, !Jeve that NRC's evaluation of physi-cal Health and other professional and', the Advisory Committee does not no-cian cunical quallf!cauons Ls necessary scientico groups, ommand that NRC become involved in. to protect the padent. They feel. that The estegory of phymfHans physf. regulating the quant!cadons of pars-tf NRC withdraws there wg! be a regu-cian g29ttps, and so on, esties la its medical personnel latory gap. Some Jtates suggest that a commenta regarding measurement of The States consider m'=*m'nktrs-phystef an's qual!!! cations should be re-dose and cabbrsden of diagnostic in-tion reporting necessary in order to viewed periodicany, for example, every strumentation and dose-measuring in-limit unnecessary radiation expceure f!ve years, to deter =!ne that he. La strumentation. Several commenters to patienta. They point out that with keeping abreasrof this rapidly chang. state emphnfwfiv that NRC has no reports of mh*Nnutrstions of by-ing fle!d. business requist!nr in this azes. Many product tnaterial or radiation from by. The gener21 sense of NHC's Advisory of them ste.te as their reason the new product material. NRC will be able to Committee on the Med!ca! Uses ofIso. au*.hority of FDA's. Bureau of Medical investigste the incident, determine if topes was that. NRC should centinue, Der!ces and the recent act!vities of the correctfre aedon is adequate and, at least for the immediate future, to FDA's Bureau of Rad! alogical Health if the problem could occur at other in-eaamine phia!cians' clinical quaulica-in developing voluntary quality con-stitutions, notify other L!censees. tion.s and should snake greater use cf trol guide 1!nes. Several other com. Physicians and physician groups are, the vanous types of board cerufcation menters state that NRC activities in in general opposed to NRC nquiring or resistration, as er!dence of ade-this area srs both welcome and neces-reports of mh*Amfnt<trations ney custe quauf! cations to practee in the' sar7 to limit unnecnury patient expo-cite the loir number of mtsadminhtrs-areas of nuclear medicine and rad!. sures. S!mHar to the States' comments, tions of radioactive snaterial to date stfon therapy. some of these latter commenters ree-combined with the fear of malpractice +0n the questfon of seleedon cf pa-ornmend NRC cooperation with FDA's suits and the 21resdy high tusurance tients. Inst: ament.t. radioactire drugs Bureau of Rad!ological Health and premiums as the principal resacns for or dertces procedures and dose level, other professional and scientif!c opposing m!_ahnhtradon reporting. the State radiation control agencies groups active In developing gu!delines They polst out that most mh*hm-beueves that NRC aliould not reguinte for dose measurement and instrument trations of d!agnosde levels of the selection of patients or instru-caHbration. radiopharmaceuticals do not harm the ments. However, the States believe The censensus of the AdMsory Com-patient. and.are mf mits e to-he*m. - _that 1*= should specify the per. mitteten thWMedicaIUses'ofIsotopes tradons of other druss. They state mitted rad!onct!ve materials and pro-is that NRC would do wen to concen. that medical institutions sad the cedures and should require adherence trate its activites on assurances that med! cal profession have precedures to InstructMus and dose schedujes la the padent recejves the proper does for denung with misnAminfvtrations. FDA approved narbe Laserta. The prescribed by the physician. The Advi-Several commenters question'NRC's physicians and the industry. bel! eve sory Committee can see no reasotr why authority to require such reporta, stat-that decisions on selection of padents-radioactive drug. doses should not be ing that this is within the tradit!cnal Instruments, rcdicactive drugs or de-- measured by weU caUbrsted instru-practice of medicine and such a report. vices, procedures and dose levels are mentagon prior to mAmW1ation to ing requiretnant would be un!que in all Enedical decisfous and traditionaDy a the padent. On the other hand. the of medical practice. Sev<.ral com-part of the pesetice of medicine. They Advisory Committee is not enthusias-menters do not obje:S to aceping re-commented that NRC should not ter. tic about the idea of NRC requirtms cords of mf tadmtnfitrations for on 11te ulate these areas. Some argued that the esUhrstion of diagnostic instru-e**=***n by NRC inspectors, but NRC has no authority to regulate In mester. ton The ext:tence of guldsunes these commenters feel that more these areas since Congress save FDA in this area and the market pressures harm than good would result from the authority to regulate the safety on manufacturers to provide quality making such reports directly to NRC, and efficacy of all drugs and medical instrumentation are two examples where they would become a part of devices. that it discussed. the pub 1!c record. The Advisory Comm!ttee on the On the question of the qualifications ne.iditsory Committee on the Medical Uses of Isotopes does nos have of parsmedical personnel. the ph7st. Medical Uses of Isotopes does not hsve a consensus on this issue. The major. cian Ludustry category !s virtually a consensus on the issue of Mad-M-Ity of the com=1ttee feels that NRC unantmous in its opposition to NRC lstrsdon reporting. The members who N ~ FDetAL 13Ctfr!I, VCt. 42, NC. 33--rtrJAY, MAAOi 17, 1773 ic y b u u}}