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Fepository: NARA Atlanta Archives OR Division of Research Isotopes Division, Oak Ridge Operatiddder: Oak Ridge, Tennessee RADIOISOTOPES FOR USB IN MEDICIBF; The use of radioisotopes in medioal researoh, diagnosis and therapy is be o ag more and more widespread as additional hospitals and medioal institutions beaoms equipped with proper fao ili ties md per8021xd t o handle radi ~ material r ~ Due t o the potential health hazards aonnected with radioactivity,the Atomio Energy Conmission has set up certain or it eri a for the allooation of radioaotive Isotope Distribution, has outlined t h e following general aims governing the distribution of radioactive materials for medical purposest 1, To make radioisotopes available for diagnostic and therapelrtio purposes where they a r e needed and a m be handled properly end snfelyo 2, To proteot, as far as possible, patients from indiscriminate use of 3 , To insure that adequate fao ili ties use the materialo Based upon ~e above general aims, the are available for those planning t o Suboommittee on Humsn Applications has formulated the following criteria for allocation o by the CommPW,ee as a wholeo These mere iater nppruved Physicians using radioactive material must be a seo ob ted wittr.mdical TOsearoh institution, hoepital, olin ic, or other medical organization possessing adequate fao ili ties and which isin good standing with the local msdioal societyo Facilities must be adequate for: a. Clinical oare of the patient, b o Assaying, safe handling and disposal o f radioaotive materialso The hospital or medical institution should appoint a local ",Isotops Committee" t o evaluate all proposals for therapeutio use of the aubstanoes within that institution,This Committee ahould mludes a. A physiaian trained in internal medioineo bo A physioian trained in hematologyo c o A n individual experienoed in assay of radiomck8rials "and proteatkin of personnel against ionizing radiationso
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4. Whenever possible, a qualified ph y sio is td a the rip w tio radioloTpe so i ent if io ally trained individual who will uae or dire otl y supervise the use of nuterial quat be ma aooredited phyaioian in good atanding with $he loo alm dio al sooiety. 4, The physician must have had pr wi o us clinioal erperienoe with radiation o r radioactive materials or be dire otl yao l labor at bg with UI individual In owe o tion with the type of isotopes whioh may be allooated for therapeutio purpqses, the Suboomittee developed the fol la ring statbnant o f polioyr be maae available for internal we in humno unless prior studies on snimalr have established the assimilatiolp3 distribution,eel eot ive localization, and excretion of the radioisotope i n queation, or its derivativb, suffioisntly well $m germit extrapolation t o man for dosage purposes. Under special oiroumot(L11oe8, the uee of long-lived radioiootopes, on whioh prior adequate animal data are not available t o establish thelmetabolio properties poted above, will be oonsidered by the Suboomrnittee. limited to patients suffering from diseased oonditiona of swh a nature %bat there i s no reasonablq probability of the radio a ot iv it y employed prodwing Tbre ww will be When requesting r&dioieotopes, an "Applioatioa f o r Radioisotope Procurement," Form AEC-513, should be oompleted and submitted t o t h e Isotopes Divieion, Uo So Atomic Bnergy Commission, Post Office Box E, Oak Ridge, TemsseeO The Isotqpes Division will submit all applications involving the use of human be in p to the Subcommittee on Human Applioatioas for their review and reoommendation. l o authorization for proourement i s given until the Subcommittee ha& hdi cate d approval In filling out Form 313, the following points should be kept in mind: I t e m 1 - Name and Addretpa of dpplioantt atudy patients under the auspioes of the applying in et it uti on and adequate necords rill be maintained at t bt institution. The Institution rupp ly hg the The physician will treat o r 2. Tten 3 - lame and Title of Scientifi o ally Trained Individual Who Will We or Dire otl y Supervim Use of llaterialst he the acoredited physioian in go& standing with the looal msdioal society hose qualifications were outlined above. Item9 - State Proposed Use of Radiomaterid and Bsneral Plan of lnveatiipfonaa ti on t The polrtd inc€ioated here must Included under this item or attached thereto must be the follo-g
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A written statement of approval from the local Isotopes Committee. The types of cases for which material will be administered. The number of patients to which materials will be administered. e 8 Frequency of treatment per patient. f , Nature of samples t o be taken for measurement. 4, Part2 of Form AEC-313, dealing with radiation instruments and health protection facilities, should be completed and filled out in detail. Before an allocation of radioisotopes may be made, the Isotopes Division must have received three copies of "Acceptance o f Terms and Conditions for Order and Reoeipt of Byproduct Materials (Radioisotopes)," This document must be completed and signed by an official in the institution who i s authorized t o 1, A laboratory should be set aside for exclusive use i n handling and ohemical processing of radioisotopeso 2, There should be a separate room and equipment available for pk hg measure m nts of radioactivity. These measurements are necessary because the supplier makes no guarantee as t o radioactive strength and quality of the 3. There should be available proper storage space for the isotopic material and for the special equipment that is used in the handling operations, 4 0 To coordinate the handling and measurement of the materials, it i s often desirable to have a specially trained physicist make the necessary measurements, and a radiochemist t o perform handling operations. Quite often one individual is qualified to carry out both of these functions. 5. It should be noted that regulations in effect under Section 505( i) of the Federal Food, Drug and Cosmetic Act provide that,prior to distribution of a new drug in interstate commerce, the shipper must have a statement on file from the applicant certifying that the applicant has adequate facilities for the investigation and that such drug will be used solely by him or under his dire o tion. invest iga tio q, whether for experimental animals o r human beings have been classified as new drugs, Radioelements intended for drug u8e o r