ML20044H020
| ML20044H020 | |
| Person / Time | |
|---|---|
| Issue date: | 08/28/1989 |
| From: | Cunningham R NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | Chosey, Glenn J, Kinneman J NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION I), NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION II), NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| Shared Package | |
| ML20044H015 | List: |
| References | |
| HPPOS-262, NUDOCS 9306070221 | |
| Download: ML20044H020 (36) | |
Text
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<1
- n HEMORANDUM FOR
Those on Attacheo List FROM:
Richard E. Cunningham, Director Livision of Industrial anc Medical Nuclear Safety, NM55
SUBJECT:
POLICY AND GUIDANCE DIRECTIVE FC'66-1 REVISION 1:
RADI0 ACTIVE DRUG RESEARCH COMMITTEES In accordance with the procedures establi. ed in Policy and Guidance Directive FC 86-1, dated February 7, 1985, this directive provides guidance about review of requests from specific licensees (both limited scope and broad scope) that want to aaminister radioactive matcrials to humans for research purposes.
1.
BACKGROUND INFORMATION Some research studies involve the administration of radioactive materials to humans that are within the purview of the Food and Drug Administration's (FDA's) Radioactive Drug Research Committees (RDRCs). The regulations establishing RDRCs ano defining their role are found in section 361.1 of 21 CFR 361 revisea April 1985, and are contained in Enclosure 1.
The most current listing of FDA-approved RDRCs wrs revised July 27, 1988, and is contained in Enclosure 2. is a letter from FDA to the chair-person of each FDA-approved RDRC, clarifying the role of RDRCs and the types of studies that come within an RDRCs purview. contains a sample limited scope license condition, and Enclosure 5 contains a broad scope license condition.
Keep in mind that an RDRC, acting in its official role as a committee approved by FDA, may ceal only with research projects involving drugs. Accordingly, research studies that involve a bone mineral analyzer, Orachytherapy sources, or other sealed sources and devices are not within the scope of section 361.1 of 21 CFR 361. Further, section 361.1 excludes clinical studies with a diagnostic or therapeutic benefit. However, FDA has indicated that "this regulation dces not in any way prohibit an institution from involving its Radioactive Drug Research Committee in other policy matters,... if it so chooses" (40 FR 31304, July 25, 1975).
Every broad scope licensee authorizeo to perform " medical research" is also i
authorized to perform human research studies. Therefore, most broad scope licensees are required to confirm access to an approved RDRC as part of the NRC license application or renewal process.
Some are only authorized for medical uses and in vitro uses under 10 CFR Parts 35 ano 31, respectively, and do not need to confirm access to an RDRC.
Note that the FDA allows an RDRC at one institution to review and approve research studies proposed to be done at another 9306070221 890828 PDR ORG NRRB PDR i
l
Those on Attachea List institution that does not have its own RCRC.
However, an RDFC at one institution is not required, by FDA regulations, to assist a second organization by reviewing its research proposals. The hRC has received reports that several institutions have decideo that they aid not want to accept responsibility for having their RDRC review proposals frcm other organizations.
On occasion, non-medical institutions have proposed to perform section 361.1 huran research studies.
Typically, these institutions ao not have the required nuclear medicine personnel to perform the studies.
In the past, such situations have been resolved af ter encouraging the institution to associate with, or contract to, a nearby medical institution in order to secure the appropriate personnel and facilities.
If the infomation specified below has been supplieo ana we are satisfied that all regulations are met, the proposed human research study tray be authorizea.
2.
LICENSING NRC has authorizea its licensees to conduct these types of studies provided certain criteria are met or certain corraitments are made.
a.
SPECIFIC LICENSES OF LIMITED SCOPE - Be sure that:
(1) The proposed authorized user is a physician as defined in paragraph 35.2 of 10 CFR Part 35.
(2) The proposed physician-user has adequate trhining and experience.
Any physician whose training and experience meet or exceed those specified in Section 35.910 or 35.920 of 10 CFR Part 35 has acequate training and experience. Physicians with less training and experience must be considered on a case-by-case basis; contact the Meaical, Academic, and Commercial Use Safety Branch staff for assistance.
(3) The proposed research project meets all the requirements of 21 CFR 1
361.1 and has been approveo by an FDA-approved RDRC.
If the reviewer 1s unsure of whether the RDRC has the authority to permit a proposed human research study, as required in 21 CFR.361.1, contact the Mecical, Academic, and Commercial Use Safety Branch staff for assistance (4) The licen'see has adequate facilities, equipment, and radiation safety procedures for handling the radioactive material proposed for use in the reseorch study.
In most cases, the licensee will not need to supply additional infomation because the typical RDRC research study involves use of no more than several millicuries of tritium or carbon-14 or other meterials that require radiation safety procedures similar to those requirea by section 35.100 of 10 CFR Part 35. contains a sample license condition for a limited scope medical license showing how a human research study may be authorized.
Those on Attached List 3
b.
SPECIFIC LICENSES OF BROAD SCOPE - Be sure that:
(1) The licensee's description of its Radiation Safety Comittee's (RSC's) criteria for selecting users should describe criteria.for those wanting to administer radioactive materials to humans for research purposes. These proposed users must be physicians as defined in section 35.2 of 10 CFR Part 35 and must have adequate training and experience.
If the licensee proposes to accept training and experience that are less than those described in sections 35.910 and 35.920 of 10 ETR Part 35, the reviewer must be sure that the criteria are adequate and reasonable in light of the licensee's entire program and should consult with the Regional section leader before accepting the proposed criteria. The section leader may in turn wish to consult with members of the ACMUI before making a licensing decision.
(2) The licensee's description of its RSC's criteria for approving proposed uses of radioactive material shall require, among other things, that research studies involving the administration of radioactive materials to humans are approved by a FDA-approved RDRC.
In its review of proposed RDRC studies, it is expected that the RSC will also consider the need for special equipment and facilities or for special radiation safety procedures. contains a sample license condition for a broad scope license showing how a human research study may be authorized..
Policy and Guidance Directive FC 86-1 is superseded by Policy and Guidance Directive FC 86-1 Revision 1, which will be per odically updated.
.S Richard E. Cunningham, Director Division of Industrial and Medical Nuclear Safety, NMSS Enclosures : As stated DISTRIBUTION w/encls hMSS R/F NRC File Center LHBettenhausen, Chief RI JGlenn RECunningham WECline, Chief RII INNS Central File IMAB R/F BSMallett, Chief RIII Chosey, RII GSjoblom WLFisher, Chief RIV JXinnaman, RI PCVacca RJPate, Acting Chief RV JWhite, RI RThomas, RV CCain, RIV RFonner, OGC MLamastra, IMAB MMoriarty, IM08 CEstep, IMNS NMcElroy, IMAB
- VMiller, GPA/SLITP GMMcCann, RIII
- See previous on r.ence ao' ur / mad 0FC:
IMAB* 1 0 t)
- IMAB*
- IMAB*
- DD/IMNS*
- D/IMNS
.........z.b.h'e r/ ga g,
.. d...
NAME: JSchluet
- NLMcElroy
- JEGlenn'
- GLSjoblom
- RECunnt(haiii DATE: 8/23/89
- 8/23/89
- 8/23/89
- 8/23/89
- 8A 9/89 0FFICIAL RECORD COPY
21 CFR Ch.1 (4-1-85 Edition) f a.d end Drwg Adaministration, HHS 9 Jest l in,16 cation under the heading " Indica. In a particular organ or fluid 1 pare i
dbmacIkfe shall be 'nown not to paragraph thH it of this section. shall t i.d* t tiat ts limited to the phrase and to describe the kinetics of that 1o-nmd LSe dose limitat.ons appUratAe he comsmsrd, shall f unction. an.1 shall
- sJur the contraction of the rallblad-rattration, rney have eventual thera to the separate administration of the obtain an ! maintalu apprownl of the el. r during diagrmstic gallbladder stud-peutic or diagnostic implirations, but active ingredients earluding the radio-Fnewt eruf litate A Iministratton in ruri g, s -
the initial studies are considered to be nuellde.
act it'arnings. Elleservedt basic research within the meaning of formity w!Ha the inflowing:
(3) 1.im d f on redisfimi dose-The t it Atembership A Ita.lloartive thug td) fisverflons. The labeling of the this acction-amount of radicartive material to be Hescarris Committer shall combt of prmfurt runta.ns the following state-tbl %e conditions under whleh use n.iministered shall be such that the at least five trullel hials Earh romrnit.
em nts under the heading ** Directions"; of radioactive drugs for research are sutgect recetves the smallest radiation tee shall inrimte the following thsee a ll ~ rake only when Instructed by a considered safe and effective are:
dose with elitch it is practical to twr.
Individuals: til A physklan erregnitro doctor:~
til Approrel by Radioecitec Draf form the study without jeopardizing as a specialist in neerlear medtrine, till
.2)" Shake well before using "
Jtesearch Com miffee. A Radicartive the benefits to be et tained from the a penon quellined br temining and es-
.33 Oral dosage is 60 milliliters 20 Drug Research Committee. composed st ud y.
perience to lure.minte radioactive rumutes before diagnostic gallbladder and approved by the $ bod and Drug til tinder no circumslances may the deugs, and (110 m t.csson w6th spertal a rey or as directed by a doctor.
Admintatradon in accordance with radiation dose to an edialt rescarth rompetence in emelaatime safety and ra-tel The word "phystrian" may be paragraph (c) of this acetion. has de-subject from a sincie study or rumula-diation dosimetry. t he semminder of siihstituted for the word " doctor ** In termined. in accordance with the tively from a numter of studica ron-the committee shall rnnsist of instivid any of the labeling statements Irt this standards act forth in paragraph tdl of ducted within 3 year he generally rec-usls otWard in various disreplancs m:tlon' thta aection. that; ognized as safe if such dme enrecits per tin" ? ss the field of ruericar medt-(D The pharmacological dose la flic following:
rhic te +,. radiology, internal medichw.
3 357 fat Professionel lebellag.
within the limits set forth in para-forming clintral pathology, hemmlnlogy, a mlo-fe lonal (but t to ile sen t t I e a a n wWnW MW W W P. W WW p
le ta mil r b s ie It a pubikt may contain the following In-Ilmita act forth in paragraph (bM3D of thta aection; physles, and redlopharmaryt Member-1.stmation for products containing a bn percent aqueous emutslon of corn tilO De radiaHon esposun b M ship shall be suf ficiently diverse to i
permit est ett review of the tertmiral oil; fndirefson. Tor visualization of fled by the quality of the study twing
,,,,JM
- "T s ased scientille aspects of proposals sub-i tilliary shacts during cholecystogra. undertaken and the Importance of the ce= *e==
mitted to the rosnmittee. The meldition I
Information it seeks to obtaln;
{
s.+ e t
of consultants in other pcrtinent medl-(1v1 The study me*ts the other re-
]
a=a*******
'S cat disciplines is enrouraged. A Hadlo-PARY 3H--PRESCRIPTION DRUG 5 quirements act forth in paragraph Edl of this settlon regarding qualtf tcations active litug Itcsearch Committee shall FOR HUMAN USE GENERALLY REC-till Pbr a research subject under 18 be either associated with a medical In-of the investigator. proper licensure years of age at his last birthday, the alltution operated for care of patients OGNIZED A5 SAFE AND EFFECTIVE for handling radtonctive materlats. se-i radiattori dose shall not enreed to per-and with sufficient arientifle capertise AND NOT MISBRANDED: DRUGS lection and consent of research sub-cent of that act forth in paragraph to allow int selection of committec USED IN RESEARCH
}ects, quality of redloactive drugs tbw3xu of Ihis acetion-members from its feruity. or =ltle a l
used, research protocol design report-tilO All radioactive material included committee established by a State an.
I 341.1 Itadissetive druge for certain re" ing of adverse reactions, and approval in the drug either as essentist material thority to provide advice on rediation I
searvin asee-by en appropriate Instituttonal or as a algniftrant enntaminant or im-health matters. Joint committees in-tal Hadloactive drugs taa defined in Review Committee; and purity shall be included when deter-volving m a than one medical Institu-1350 3tnl of this chapteil are general-tvl The use of the radlosctive # mg l
mining the total radiation doses and lion which.aave been estatiltshed in 8
ly teroanized as safe and etfective in human subjects has the approve. of l
dose commitments. Itadiattori doses order to achieve a high level and aliver-
)
whers administered, under the cond!-
the Radioactive Drug Itcaearch Can' tions act forth in paragraph tbl of this mittee.
g from a ray procedurca that are part of af ty of esperience will i e arrrplah!c.
i the research study ti c., would not The 1)lrector of the Center for finnes section, to human resentch subjects (21 Limtf oss pharmacological dose.
f have orristred but for the studyl shall and Biologirs may mmitfy an> of the during the course of a research project he amount of active ingredient or intended to obtain basic information cornbination of active ingredients to be l
also be included. The possibility of fol-foregoing requirements in a pastirular lowup studica shall be considered for altuation where alternative fartnts I
regarding the metaboltam tincluding administered shall be known not to inclusion tn the done calculations.
provide substantially the sarne rumtm-l kinetics. distribution, and localizationi cause any clinically detectable phar' invl Numerical definttlons of dose attton and assnrintfors.
l of a radloartively labeled drug or re-rnacological effect in human beings 18 shall be based on an absorbed fraction 4 2) Fas.artion. Each Padicarti c firug carding human physiology, pathophy-the same active ingredients deactusive l
method of radiation absorbed donc cal-Hesearch Commit:ec shall e -Icet a stology, or blochemistry but not in-of the radionuclidel are to be admints' culation, such as the system act forth chaltmars, who shall shrn all stilra-tended for immediate therapeutle. dl.
Lered almultaneously, e.g. under a by the Medical Internal Itadiation tiona. rninutes. and reports of l ec com-l agnostle, or almilar purposes or to de-
" Notice of Claimed Investigaponal Ex-i thee Committee of the Society of Nu-mittee. Each committre shall neet at terr.Inc the safety and ef fectivenese of emption for a New Drug'* or for a clear Medicine, or the system set forth least once each riuntler in et lose re.
tiae drug in humans for such purposee therspoutie usa in accorderice with la-by the Internatimial Comminston on search metivity has pu en ns. tim Ized or l
11 c., to carry out a clinical triad. Cer-beting for a drug approved under Part Hadlological 1*rotection, conduc ted, A setorano runst mg of t ain basic rescaeth atudies. e s.. studica 314 of this chapter, the totel amoimt I
tel A Radicartive Drug Research rnore th.an 50 twre ent of the e rmtwr-to determine whether a drug localizes of active Ingredler*ts includmg the re-Committee, in order to comply with ship m Lt be pre. cat with app upriate l
1 rut i
eem i
- _ _ _ - _ _ - - _ - _ - _ - _ - - - _ - _ = _ -
~
s 21 CFR Ch. I (4.b85 Edillen)
J and Drug Adelaistreflen. HHS
?,
re ucsentation of the required fields include art estimate of the absorbed ruol' for fatture of the committee to comply committee shall req.ilte that the inves-of perialliation. Minutes shall be kept re than one administration or's with any of the requirrments of this ligator provide pliarmarutostral time anel shall include the numerical results radioactive drus per subject. rumulative re.
section. Approval of a committee shall calculations 1:ssed oti datt av allable of votes on protomis involving use in WW Md" WW W WH h De WWW hWm m he otsuon done and dose commu ment. en-immann subjects. No rnember shall vote presned as whole bodF. active blood formans FDA withdraws such approv al.
other valid human siuit es
'" a protocol in which he Is an Investi-organs. sens of the eye. sonads, and other Changes in membership and applica-
- 43) Qualt/scattores of an <stinators organ doses from the administered radsonu-tions for new members shall be sub.
Each investigator shall be elua.sfird by R
ris. Each Radtonctive Drug codes mitted to the Food and Drug Admints-training and experience to conduct the f te. ret Committee shall submit an
'f. A claire of confidentiality,if any, tration as soon as, or before, vacancies proposed research siudies.
armust report on or before January 3l Nors Contents of this report are avaltable oreur ors the committee.
W Idrense to ha ruf fe ra<f marts w f racia yrar to the Food and Drug Ad-go, public dtarsoeure unless conodens tamp to
- 45) Montfortag The Food and Drug materials The respoemide investlan-
'"""'t r ation. Center for I) rugs and requested by the investlantor and it la ade-Administration shall conduct periodic inr or lustitutions shall, in the case of ItF % I5O 5600 Fishers anuately shown by the Investigator that the reviews of approved committees. Mont-reactor produced isotopes he Ilrrrtsed erkvill dD 20ftS't. The repers connututes a trade secret or conn-ts 11 Include the names denual commercial Informauon as def 6ned toring of the activities of the commit.
by the Nuclear Ite gulatory Commis.
a oa attons of the members of.
In 28 Crit p st.
tre shall be conducted through review ston or A greement Slate to tausess cf its annual report. through review of and use the specific radionurlldes for avut os any consultants trsed by, the minutes and fuH protoceds for redsin warch use m he a Ned invesHanW i
Itulloactive Drug itescarch Commit-Inveausato, studica. and through on site inspec-uruler a broad tk ense. or in the casc ot t
arut. for each study conducted tions.
non tractor produced Isotopes, be II.
I sing the precedmg year a summary (d) in snaking the determination re-censed by other approl rlate State or of Information presented in the fel' Chairman, fladlonctive Drus qulted in paragraph ibHI) of this sec-local a uthoritics, w hen required by lowl"3 forennt'.
Itesearch Committee lion. a Radioactive Drug flesearch State or local law. to lesschs and use steront om Itase.ancis tiss or Itassoactiva At any time a proposal is approved Committee shall consider the follow-the specific radionurtides for research tinos which involves exposure either of ing requirements and assure that each use_
is met:
- 1. Title of the research protect-more than 30 research subjects. or o
- 15) ffumers research sufsfects. Each (1) Raddaffora dose to sub)ccf1 To investigator shall srlect aptiropriate 2 Halef desertption of the purpose of the any research subject under 18 years o research prolect.
age. the committee shall Irnmediately assure that the radiation dose to re-human subjects and shall obtain the 3 Name of the investinator responsible, sul mit to the Food and Drug Admints-search subjects la as low as practicable review and approval of an institutional
( pharmacolostral dose.
tration a special summary of *nforma-to perform the study and meet the crl-review committee that ronternss to the a Aruve incredients.
Lion in the format shown in this para-terla of n 361.ltbM31. the Radioactive requiremen's of I' art 56 of this chap-b wtamtmum amount administered per Drug Research Committee shall re-ter, and shall obtain the crwwnt of graph. Contents of these reports are auhint-qutre that:
S H *"' 'I 8 h' '*d'*"
g" available for public disclosure, unless the subjects or their legal rr presenta-ciudins anF present. as S,"#'
ta' mil confidentiality is requested by the in.
(D The investigator provide absorbed Lives In accordance with I' art 50 of this
$t t
vestlgator and It la adequately shown dose calculations based on biologic dis-chapter. The researth subjects shall tribution data available from pu b-s ad t bsorbed done. Provide the by the Investigator that the report maalmum dose commatement to the whole constitutes a trade accret or confiden lished literature or from other valid be at least 18 years of age and legally studies.
competent. Esreptions are permitted body and each orsen specified in at CFit (lat commercial Information as def only In those sperial situations when it 3sa.stbu3 min that was reces,ed by a repre-In i 20.6l of this chapter.
ilD The investigator provide for an can be demonstrated to the committee to Approvat Each Radlosctive Drug I
acceptable method of radionssay of n,ntstive sublect and the calculations or rer-erences that were used to estigte the*( Research Committee shall be specift-the radioactive drug prior to its use to that the study presents a untouc op.
,,i e
t abution o th cally approved by the Center for assure that the dose calculations actu-portunity to gain information not cut-
'"* *$$d ally reflect the administered dose.
rently available, requires the tase of re-search subjects less ther 18 years of tie administered radsonuclidetst and any X-Drugs and Illologics of the INod at tiill The radioactive drug chosen for say procedures emoclated with the study. If Drug Administration. Applicatto the attsdy has that combination of the subject. Studies involving minors age, and is without significant rish to the stud, criesta data oss the uptake or es-shall be submitted to the 3%od nr Drttg Administration. Center for Italf-life, types of radiations. radiation shall be supone ted wit ti
- r. vlew by tretton of the radioactjve drum pertinent to Drugs and Biologics. IIPN-150, 5800 energy. metabollsm. chemical proper-the estimation of done commitment, report ench aubleci provide-Fishers Lane. Rockville. IWlO 2085b ties, etc., which results in the lowest quellfled pediatric consultan s to the the mean value and rense of values. For Redloartive Dring Itesearch t'ommit-tens weleR and shall contain the names and'
.1-dose to the whole body or specific tee. Eau Temale re:.carch s ablect of fhn ee n t
yo a h radionuclide ad.
Ilcations of the members of the co organs with which it is possible to childlwaring sustentini shall state in obtain the necessary Information.
ministered for each radioactt e drus insed in mittee, and a statement that the writintt that she. Is suit preens it,or.on the study. Report each x.eny procedure mittee agrees to comply with t (lvt The havestigator utilize adequate the basis cf a precis sucy to be con-used in conjunction eith the study-qulrements set forth In this section.
and appropriate instreamentattori for I!rmed as not pees:nant, tM tore she a o If the subject has participated in other Approval shall be based upon an as-the detection and measurement of the rastoartive drue research studies. report the messment of the quallfications of the apeelfle radionuclide.
may perticipate in any study.
name et the vedteact%e drus used in these 128 Marmacological dosage. To de-t6) Qunhty of ractnaarine e rno The members of the committee. navi the as-termine that the amoimt of active in-radioat tive drase usol in the sesearch pertise are covered." Approval study shall meet app e priate hemical W ""C'
" #I M
EMMshd he nd phama'en&st raWuilu2M, and ra$
th tote a t vt y of each d u a
a montseered 18 any X-ray procedures were enreed the limitations set forth in t!! onus hdic st andmi. of u tent 61 y.
uwd. Identif y the x ray proceduretsi and mittee may De willedrawn at sny paragraph (bH2) of this settlan. the strengt h. quaht y. and purit y.. nerdal som 199
I g 3 g,g 21 CFR Oi. I (4-1-85 Edillen) ed and Drug Asiministrellen, HHS 5 369.1 for safety and be of such uniform and forms to the requ* ements of Part 564 til Trste amounts of harmless suth see.
reprmlurlble quality as to give signift-of this chapter.
stances added solely for Individual 1.hpeet S - wee a.g.ad M n 5' ' ~'"
cance to the research study conducted.
let The results of any research con-product identification need not be tw %
The Itadioactive Drug Research Com-ducted pursuant to this section as part named.
smelee shall determine that radioac. of the evaluation of a drug pursuant tir.* materials for parenterst' use are to 3 312.1 of this chapter shall be in-m) If the drug Is intended int paren.
388 0 Dmes: *erornmended *amins and teral use, the quantity or progmrtion sere-pared in sterile and pyrogen free t fa inactive ingredients, except that I" "*
u e i 2.1 of thi h ner lents added to adjust pit or to 26922 en :
Ired reau tt e7 presearch profocol No matter (D A radioactive drug prepared, Druss. =arntna amt roution state.
liow small the amount of radioactivity.
gg g make the drug isotonic may be de.
ments pectricatfr rewsteed by ta=.
no study involving administration of a Intended for use In accordance with clared by name and a statement of twheartsve drug.
as defined in the requirements of this section shall their effect; If the vehicle is water for m,,,g m g g,
~83 1310 3tnl of this chapter. to rcsearch be esempt from acction 502(f Wil of Inlection, it need not be named. Pro, Stat. t050. as amended [3052 na stat. as4. ss st t. es: 6 3,,
sublects under this section, shall be the nct and tl 201.5 snd 201.100 0f this
aded. homecer. That in the case of amended. 62 samt t oS5'. a.s amen ted "(2
,3 gicemitted unless the Itadioactive Drug chapter if the packaging, label, and la-containers too small or otherwise (LS C. 252. 332, ass 257,33 g,,
Itchcarch Committee concludes, in its beting are in compliance with Wderal, imable to accommodate a lehel with ju.lgment, that scientific knowledge Blate, and local law regarding radioac.
sufficient space to bear all such infor-socare. 33 pyg g g3, otherwise noted~
tive materials and if the label of the mation, the information requirett by and benefit is likely to result from Immediate contalper and shielded con.
paragraph (fl til and 812) of this sec' that study. Therefore, the prot > col Sub ort A-Definiffons and shall be based upon a sound rationale tainer, if any, either separate frorn or Lion may be placed on the shielded P
as part of any label and labeling re-container only.
Int *rProletions derived from appropriate animal stud-qutred for radioactive materials by the les or published Itterature and shall be Nuclear Regulatory Commission or by 505. MHan. 52 stat. 1032-tos2. as B 3891 Purpene of la...,
of sound design such that informati "
State or local radiological health au.
Q
$5[21 255,3 he i.the of scienttile value may resu ra-The warning and caution statements thorities bear the following-diation dose shall be both sufficient 102, as amended (42118 C. 262H)
- g -
til The statement "Cautlost Federal suggested in Subparta Il and C of this part, for inclusto I 9 $.g"on
' [
,"g[{[g Drug, and Cosmetic Act et ruin ai ensur ment.
e pr M d Wursand 42 t
te e
sb see jetted number of subjects shall be sul-g.he statement **I'o be admints-l e e an an t r f 6cient but no greater than necessary e g g
tered in compliance with the require-tett 58 Fit sese. Mar. e. Iss51 for the purpose of the study. The ments of Federal regulations regad immber of subjects shalt also reflect Ing radioactive drugs for research use the purpose of assisting ludustry in the fact that the study to intended to (2,1 C, Fit 361.11";
l' ART W-INTERPRETATIVE STATE. Preparing pmper labcHng for these ar.
obtain basic research infortnation re-3 rne estabiished name of the mENTs RE wARNinos ON oRuos ' ' ' ' ' ' ' '
he ra"nier $ ale and in ferred to in paragraph tal of this sec-drug,ifany; AND DEVICES FOR OVER-THE~
9""'**"I*"Ith*
tion and not Intended for immediate
- 14) The established name and quan-CO9NTER SA1E he label or labeHng of drugs therspeutic, diagnostic or almtlar pur-tity of each active Ingredient; i
and devices hear adequale warnings, in tmses or to determine the safety and (S) The name and half-Ille of the ra-S.bpa,r A-e such manner and furns as are neces, ef fectiveness of the drug in humans dionucIlde, total quantity of radlone.
g w+ -
tary for the prolcetion of users. Only fur such purpnacs (l.e to carry out a tsvity in the drug product's immediate
/
container. and amount of radioactivity 8i Purpose of lasuance.
section 502td) of the art requires use clinical trlall.
(8) Adrierse reactions. The investiga-per unit volume or unit mass at a des.
E efinitions.
of the specific language included in these suggested warning and caution for shall immediately report to the Ignated referenced time; arnines required on drugs esempt. statements. These suggested warnin
,,,'g,edf],M,y,,l,M,,pg nslng require-or r,aution statements are Illustrativ Itadiozctive Drug flesearcia Commit-telThe route of administration if it lee all cdverse effects associated with is for the other than oral use; u,g w,,,,n,,
," d M hse that may be necessa ry or de.
the use of the radioactive drug in the (1)The net quantity of contenta:
garm,3,, gn,,,,,,,,,,,,,,d F
sirable. It is the responsibill y of the research study. All adverse reactions (8) An identifying lot or contro e,e ts of g
3eg g ***l"88 required on insulin intend ~ manuf acturer. packer. shiptu r~ or dis-probably attributable to the use of the number from which it is possthic to de-g ed for owe the-counter sat radior.ctive drus in the research study termine the complete manufarturing 369 e Warninas tributor in interstate romme re to see t
regulsed on certfflable that such statements are adr shall be immediately reported by the history of the package of the dring.
antibsoucs esempted from premedption. compliance witte the prowlslo f gg nate f Itadiosctive Drug Itescarch Commit-(9) The name and address of the dispenssas requieementa.
lee to the Food and Drug Administra-manuf acturer. parker, or distrib stor; M81 law O nissa f
Warnsnes required by official com-suuskested I st to
.if, tion. Center for Drugs and Diologica.
I103 The expiration date, if ant, I' #
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ilPN-153. 5800 Fishers Lane. Rock-till If the drug is intended for par.
g ga Warning statements in relation to ggte ac, im and el.v d N m s ns of valle. MD 20857.
enteral use, a statement as to wisetbe*
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8 retelles beant. The invoettgator shall (131 If the drug la for oil er than a
phtsin the review and approval of an oral use, the names of all inactive lo*
l au g %"""*"""*"s et waenans state.
1etm nts are nem si.rp or tralra ble 8* Eld Drotuert son os stic user g
institutional redew board that con-gredients. except that j
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CURRENT COMMITTEE CHAIRPERSONS AND ADDRESSES FOR RADI0 ACTIVE DRUG RESEARCH COMMITTEES i
^
BY STATE I
NOTE:
Comaittee's listed as INACTIVE have been inactivated voluntarily by the respective committee chairperson.
This is for the convenience of both the FDA and the institution itself.
There is no prejudice toward reactivation should the need arise, STATE and RDRC No.:
CHAIRPERSON and ADDRESS ALABAMA 0063 Hilliam P. McCann, M.D., Chairperson Radioactive Drug Research Committee Pharmacology Department Room 116, Volker Hall University of Alabama in Birmingham Birmingham, AL 35294 0076 Johnny H. Scott, Ph.D., M.D., Chairperson Radioactive Drug Research Committee Chief, Nuclear Medicine Service (115)
Veterans Administration Medical Center 700 South 19th Street Birmingham, AL 35233 0140 INACTIVE Hyron L. Lecklitner, H.D., Chairperson Radioactive Drug Research Committee Chief, Nuclear Medicine Service University of South Alabama 2451 Fillingim Street (310 MSN)
Mobile, AL 36617 0154 James H. Ballard, M.D., Chairperson Radioactive Drug Research Committee Baptist Medical Centers 701 Princeton Avenue, S.H.
Birmingham, AL 35211 t
ARIZONA 0099 INACTIVE James Hoolfenden, M.D., Acting Chairperson-Radioactive Drug Research Committee Nuclear Medicine Service Arizona Health Sciences Center Tucson, AZ 85724 l
_ _,, _ _ _ _ _ _ _ _ _ - _ _ _ _. _ _ _ - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - " - - - - - - - ^ = - - - - - - - - -
Fage c ARKANSAS:
0109 Charles H. Boyd, M.D., Chairperson Radioactive Drug.Research Committee Division of Nuclear Medicine University of Arkansas for Medical Sciences 4301 Hest Markham Little Rock, AK 72205 CALIFORNIA 0020 David A. Goodwin, M.D. Chairperson Radioactive Drug Research Committee Nuclear Medicine Department (115)
Veterans Administration Medical Center 3801 Hiranda Avenue Palo Alto, CA 94304 0028 Samuel E. Halpern, M.D., Chairperson Radioactive Drug Research Committee Chief, Nuclear Medicine Service (115) 3350 La Jolla Village Drive San Diego, CA 92161 0036 Walter Holf, Ph.D., Chairperson Radioactive Drug Research Committee University of Southern California School of Pharmacy 1985 Zonal Avenue Los Angeles, CA 90033 0038 Henry H. Stauffer, H.D., Ph.D., Chairperson
' Radioactive Drug Research Committee 459 Donner Laboratory Lawrence Berkeley Laboratory University of California Berkeley, CA 94720 0041 Norman S. HacDonald, Ph.D., Chairperson Radioactive Drug Research Committee Laboratory of Nuclear Medicine Department of Radiological Sciences i
University of California, Los Angeles 10833 LeConte Avenue Los Angeles, CA 90024 0047 Norman A. Baily. H.D., Chairperson Radioactive Drug Research Committee Department of Radiology, H-010 Univerisity of California, San Diego La Jolla, CA 92093 I
Page 3 0054 Carol S. Marcus, H.D., Chairperson Radioactive Drug Research Committee Nuclear Medicine Division - Box 23 Los Angeles County Harbor /UCLA Medical Center 1000 West Carson Street Torrance, CA 93509 0059 Rodney E. Hillard, M.D., Chairperson Radioactive Drug Research Committee Pathology Department Loma Linda University Medical Center Loma Linda, CA 92354 0060 Marvin B. Cohen, M.D., Chairperson Radioactive Drug Research Committee V.A. Medical Center 16111 Plummer Street Sepulveda, CA 91343 0062 H.H. Blahd, M.D., Chairperson Radioactive Drug Research Cominittee V.A. Medical Center West Los Angeles Wadsworth Division (691/H115)
Hilshire and Sawtee Boulevards Los Angeles, CA 90073 0071 Chin-Tzu Peng, M.D., Chairperson Radioactive Drug Research Committee Room C-116 University of California San Francisco, CA 94143 0072 Roger H. Hallace, Ph.D., Chairperson Radioactive Drug Research Committee Nuclear Engineering 4103 Etcheverry Hall University of California 0082 INACTIVE Richard Lepage, Pharm.D.
Radioactive Drug Research Committee Nuclear Pharmacy Nuclear Medicine Service Naval Regional Medical Center San Diego, CA 92134 l
rage 4 0092 Lawrence Laslett, M.D.,' Chairperson
~,
Radioactive Drug Research Committee Cardiology Department U.C. Davis Medical Center 2315 Stockton Boulevard Sacramento, CA 95817 0096 INACTIVE Robert J. Lull, M.D., COL, MC, Chairperson Radioactive Drug Research Committee Letterman Army Medical Center Presidio of San Francisco, CA 94129-6700 0098 Joseph G. Llaurado, M.D., Ph.D., Chairperson Radioactive Drug Research Committee Jerry L. Pettis Memorial Ve
- ans' Hospital-11201 Benton Street Loma Linda, CA 92357 0108 Houssa Raiszadeh, Ph.D., Chairperson Radioactive Drug Research Committee c/o Kenneth P. Lyons, M.D.
Veterans Administration Medical Center Nuclear Medicine Service 5901 East Seventh Street Long Beach, CA 90822 0156 Philip Braunstein H.D., Chairperson Radioactive Drug Research Committee Department of Radiological Sciences University of California Medical Center, Irvine University Hospital Orange, CA 92668 0164 Vinton C.fVint II, M.D., Chairperson Radioactive Drug Research Committee Scripps Clinic and Research Foundation 1066 North Torrey Pines Road La Jolla, CA 92037 Donna R. Earley, H.S.
Director Radiation / Environmental Safety Cedars-Sinai Medical Center Box 48750 Los Angeles,'CA' 90048 Berkeley, CA 94720
Page 5
~
COLORADO 0130 INACTIVE Kim Adcock, M.D., Chairperson Radioactive Drug Research Committee Chief, Nuclear Medicine V.A. Medical Center Denver, CO 80220 0135 Victor H. Spitzer, Ph.D., Chairperson Radioactive Drug Research Committee University of Colorado Health Sciences Center Department of Radiology 4200 East Ninth Avenue, Box C-278 Denver, CO 80262 0139 John K. Podgore, D.O., COL, MC, Chairperson Radioactive Drug Research Committee Chief, Dept. of Clinical Investigation Fitzsimmons Army Medical Center Aurora, CO 80045-5001 CONNECTICUT:
0120 Eugene A. Cornelius, M.D., Ph.D., Chairperson Radioactive Drug Research Committee Department of Diagnostic Imaging Yale-New Haven Hospital 20 York Street New Haven, CT 06504 0126 Lucille Soldano, M.D., Chairperson Radioactive Drug Research Committee V.A. Medical Center Hest Haven, CT 06516 0131 Peter Setlow, Ph.D., Chairperson Radioactive Drug Research Committee c/o Vincent T. Peninas, 0.D., Ph.D.
Department of Radiation Safety University of Connecticut Health Center Farmington, CT 06032 DISTRICT OF COLUMBIA 0023 Hajor Janet Neutz, M.D., Chairperson Radioactive Drug Research Committee Assistant C - Nuclear Medicine Service Halter Reed Army Medical Center Washington, D.C.
20307-5001
Page 6 J024 Barry H. Wessels, Ph.D., Chairperson Radioactive Drug Research Committee Division of Radiuation Oncology and Biophysics George Hashington University Medical Center 901 23rd Street N.H.
Washington, D.C.
20037 0029 INACTIVE Kenneth D. Hilliams Radiation Safety Officer Radioactive Drug Research Committee The Washington Hospital Center 110 Irving Street, N.H.
Washington, D.C.
20010 0050 INACTIVE James Smith, M.D., Acting Chairperson Radioactive Drug Research Committee Veterans Administration Medical Center 50 Irving Street, N.H.
Washington, D.C.
20422 0053 John C. Rose, M.D., Chairperson Radioactive Drug Research Committee Radiation Control Office Georgetown University Hedical Center 3750 Reservoir Road, N.W.
Washington, D.C.
20007 0134 Massoud Majd, M.D., Chairperson Radioactive Drug Research Committee Department of Radiology Children's Hospital National Medical Center 111 Michigan Avenue, N.W.
Harbington, D.C.
20010 FLORIDA:
0074 INACTIVE Steven J. Harwood, M.D., Chairperson Radioactive Drug riesearch Committee Chief, Nuclear Medicine Service V.A. Medical Center Bay Pines, FL 33504 0129 Vincent P. Gotz, M.S., Chairperson Radioactive Drug Research Committee i
Box J-4, JHHHC University of Florida-Gainesville, FL 32610
rage <
i '
0136 Hilliam Smoak, M.D., Chairperson Radioactive Drug Research Committee Department of Nuclear Medicine Mount Sinai Medical Center 4300 Alton Road Hiami Beach, FL 33140 GEORGIA:
0040 Naomi P. Alazraki, M.D., Chairperson Radioactive Drug Research Committee Department of Nuclear Medicine Emory University Hospital Atlanta, GA 30322 0073 INACTIVE Parshan Ramsingh, M.D., Chairperson Radioactive Drug Research Committee Medical College of Georgia Department of Nuclear Medicine AuguLta, GA 30912 IDAHO:
0158 Lawrence L. Knight H.D., Chairperson Radioactive Drug Research Committee V.A. Medical Center (113) 500 West Fort Street Boise, ID 83702 ILLINOIS:
0004 Steven Pinsky, M.D., Chairperson Radioactive Drug Research Committee Michael Reese Hospital and Medical Center 29th and Ellis Avenue Chicago, IL 60616 0043 INACTI'4 Robert S. Halcolm, M.D., Chairperson Radioactive Drug Research Committee The Methodist Medical Center of Illinois 221 Northeast Glen Oak Peoria, IL 61636 0067 James W. Ryan. H.D., Chairperson Radioactive Drug Research Committee University of Chicago Department of Radiology (Nuclear Medicine) 5841 S. Maryland Aver,ue Hospital Box 429 Chicago, IL 60637
Page 8 l
0097 Ervin Kaplan, H.D., Chairp?rson.
Radioactive Drug Research Committee.
Chief, Nuclear Medicine Service (liSA)
V.A. Medical Center Hines, IL 60141 0117 Raymond C. Barrall, Chairperson Radioactive Drug Research Committee The University of Illinois at Chicago Radiation Safety Office !H/C 932) 339 Clinical Sciences-North Hing Box 6998 Chicago, IL 60680 0138 Lee F. Rogers, M.D., Chairperson Radioactive Drug Research Comittee Northwestern Memorial Hospital Department of Radiology 250 E. Superior Street 7.nd Fairbanks Court Chicago, IL 60611 0148 James J. Conway, M.D., Chairperson Radioactive Drug Reasearch Comittee Department of Radtology The Children's Memorial Hospital 2300 Children's Plaza Chicago, IL 60614 0157 Pramilla Sarin, M.D., Chairperson Radioactive Drug Research Comittee Evangelical Health Systems Christ Hospital 4440 West 95th Street Oak Lawn, IL 60453 0159 Robert E. Henkin, M.D. -Chairperson Radioactive Drug Research Committee Director of Nuclear Medicine Foster G. McGaw Hospital Loyola IJ"!versity of Chicago 2160 South First Avenue Haywood IL 60153 0165 Sant P. Singh, M.D., Chairperson Radioactive Drug Research Comittee Associate Chief of Staff for Research V.A. Medical Center North Chicago, IL 60064
Page 9
-i INDIANA:
0014 Jon P. Lindemann, M.D., Chairperson Radioactive Drug Research Committee Indiana University Medical Center 1001 West 10 th. St.
Indianapolis, IN 46202 0137 INACTIVE Larry L. Heck, M.D..-Chairperson Radioactive Drug Research Committee Department of Radiology Hethodist Hospital of Indiana 1604 North Capital Avenue Indianapolis, IN 46202 IQEA:
0048 James L. Spratt, Ph.D., M.D., Chairperson Radioactive Drug Research Committee 2-250 Bowen Science Building Iowa City, IA 52242 KANSAS:
0008 Ralph G. Robinson H.D., Chairperson Radioactive Drug Research Committee University of Kansas Medical Center 39th and Rainbow Kansas City, KS 66103 KENTUCKY:
0151 U. Yun Ryo, M.D., Ph.D,. Chairperson Radioactive Drug Research-Committee University of Kentucky Medical Center Lexington, KY 40536-0084
? age 10 LOUISIANA:
0006 INACTIVE David J. Bush, M.D., Chairperson Radioactive Drug Research Committee Ochsner Clinic 1514 Jefferson Highway New Orleans, LA 70121 0087 Yogendra S. Goel, M.D., Chairperson Radioactive Drug Resehrch Committee V.A. Medical Center 510 East Stoner Avenue Shreveport, LA 71130 M_ARYLAND:
0018 Loren A. Zech, M.D., Chairperson Radioactive Drug Research Committee National Institutes of Health Building 10 Room 4B-56 Bethesda, MD_ 20205 0031 INACTIVE John H. Shaver, Chairperson Radiation Safety Officer Francis Scott Key Medical Center Occupational Safety and Environmental Services 4940 Eastern Avenue Baltimore, MD 21224 0033 Edward U. Buddemyer, Ph.D. Chai'. person Radioactive Drug Research Committee University of Maryland Radiation Safety Office 660 West Redwood Street Baltimore, HD 21201 0042
, Chairperson Radioactive Drug Research Committee' Department of Nuclear Medicine The Johns Hopkins Hospital 600 N. Holfe Street Baltimore, MD 21205 0066 INACTIVE James D. Parker. H.D.. Chairperson Radioactive Drug Research Committee Department of Nuclear Medicine Prince George's General Hospital,and Medical Center Cheverly. HD 20785
Page 11 MASSACHUSETTS 1 0002 David E. Drum, M.D., Chairperson Radioactive Drug Research Committee Brigham and Homen's Hospital 75 Francis Street Boston, MA 02115 0016 Gerald H. Kolodny, M.D., Chairperson Radioactive Drug Research Committee Division of Nuclear Medicine Beth Israel Hospital-330 Brookline Avenue Boston, MA 02215 0030 INACTIVE Paul Kahn, M.D., Chairperson Radioactive Drug Research Committee Chief, Nuclear Medicine New England Medical Center Hospital 171 Harrison Avenue Boston, MA. 02111 0032 Edward H. Hebster, Ph.D., Chairperson Radioactive Drug Research Committee Department of Radiology-Hassachusetts General Hospital Boston, MA 02114 s7 INACTIVE Hillard S. Putnam, Jr., M.D., Chairperson' Radioactive Drug Research Committee Massachusetts Institute of Technology 77 Massachusetts Avenue Cambridge, MA 02139 0079 Salvador Treves, M.D., Chairperson Radioactive Drug Research Committee The Children's Hospital Medical Center 300 Longwood Avenue Boston, MA 02115 0080 John T. Chaffey, M.D., Chairperson Radioactive Drug Research Committee New England Deaconnes Hospital 185 Pilgrim Road Boston, MA 02215 0163 Lewis'E Braverman, M.D., Chairperson Radit'ia /e Drug Research Committee Depa
at of Nuclear Medicine Unive.,ity of Massachusetts Medical Center 55 Lake Avenue North Horcester, MA 01605
eage si i
0088 Edward L. Klaiber, M.D.
Radioactive Drug Research Committee Senior Scientist Horcester Foundation for Experimental-Biology.,
222 Haple Avenue l
Shrewsbury, MA 01545 0118 INACTIVE Belton A. Burrows, M.D., Chairperson Radioactive Drug Research Committee University Hospital 75 East Newton Street Boston, Ma 02118 MICHIGAN:
0045 Brahm Shapiro, M.D., Ph.D. Chairperson Radioactive Drug Research Committee The University of Michigan Radiation Control Service 1101 North University Building 1205 North University Avenue-Ann Arbor, HI 48109 0085 James R. Doicn, M.D., Chairperson-Radioactive Drq Research Committee Bronson Methodist i'Ospital 252 East Lovell Street Kalamazoo, HI-49007 0095 Jai Y. Lee, M.D., Chairperson Radioactive Drug Research Committee Staff Physician, Nuclear Medicine Service V.A. Medical Center Allen Park, HI 48101:
0107 INACTIVE Richard'Cummings, Acting Chairperson Radioactive Drug Research Committee Director of Health-Physics Radiation Control Department Radiation Safety Officer-Hayne State University 645 Hullett Street Detroit, HI 48226 C.
Page U 0110 INACTIVE Vemblaserry Jayabali-H.D., Chairperson Radioactive Drug R
.srch Committee.
Nuclear Medicine Set see Hurley Medical Center One Hurley Plaza 1
Flint, HI 48502 i
0112 INACTIVE Halter Nikesch, Ph.D.
Radioactive Drug Research Committee Radiation Therapy Department Saint John Hospital 22iOI Moross Road Detroit, HI 48236 0115 INACTIVE David H. Woodbury, M.D., Chairperson Radioactive Drug Research Committee Nuclear Medicine Service Wayne County General Hospital Eloise HI 48132 0125 Darlene Fink-Bennett, M.D., Chairperson Radioactive Drug Research Committee Nuclear Medicine Department Hilliam Beaumont Hospital 3601 Mest 13 Mile Road Royal Oak, HI 48072 0133 INACTIVE Kenneth L. Krabbenhoft, M.D., Chairperson Radioactive Drug Research Committee Department of Radiology Detroit Receiving Hospital-4201 Saint Antoine Boulevard Detroit HI 48201 0141 INACTIVE Jaroslaw Huz, M.D., Chairperson Radioactive Drug Research Committee Harper Hospital Nuclear Medicine Section 3990 John R Detroit, MI 48201 0162 Kenneth D. McGinnis, M.D.
Radioactive Drug Research Committee Mount Carmel Hercy Hospital Department of Radiology and Nuclear Medicine 6071 West Outer Drive Detroit, HI 48235 l
l Page-14 i
s.
_4 BJNNESOTA:
0017 G. S. Forbes H.D., Chairperson Radioactive Drug Research Committee Mayo Clinic 200 First Street Southwest Rochester, MN 55905 0132 S.H. Tsai, M.D. Chairperson Radioactive Drug Research Committee Hennepin County Medical Center 701 Park Avenue South Minneapolis, MN 55415 0145 John Van Pilsum, Ph.D., Chairperson Radioactive Drug Research Committee c/o Mr. Jerome H. Staiger Radiation Protection Officer Department of Environmental Health and Safety University of Minnesota Minneapolis, MN 55455 HISSOURI:
0027 Hr. Lynn R. Hendershott, Chairperson Radioactive Drug Research Committee Nuclear Medicine Service (115 JC)
V.A. Medical Center St. Louis, MO 63125 0049 INACTIVE Harold F. Daum, M.D., Chairperson Radioactive Drug Research Conmittee Bothwell Regional Health Center.
644 East 13th Street Sedalia, HQ 65301 0068 Halter G. Dukstein, M.D., Chairperson Radioactive Drug Research Committee Quincy Resear.5 Center 5100 East 24th Street Kansas City, MO 64127 0122 Barry A. Siegel, M.D., Chairperson Radioactive Drug Research Committee Hallinckrodt Institute of Radiology 510 S. Kingshighway Blvd.
St. Louis, H0 63110
f Page 15 4
,.y.
0152 Larry D. Samuels, M.D.,l Chairperson Radioactive Drug Research Committee Director Nuclear Medicine St. Louis University Medical Center 1325 S. Grand-St. Louis, HO 63104 0155 Donald R. German, M.D., Chairperson Radioactive Drug Research Committee St. Luke's Hospital of Kansas. City.
Hornall Road at Forty Fourth
+
Kansas City, MO 64111 NEBRASKA:
0064 Merton A. Qualfe, M.D., Chairperson Radioactive Drug Research Committee Director, Nuclear Medicine-Department of Radiology-University of Nebraska Hospitals & Clinics 42nd Street & Dewey Avenue Omaha, NB 68105-HEH HAMPSHIRE:
0149 Donald L. Herzberg, M.D., Chairperson Radioactive Drug Research Committee
.The Hitchcock Clinic Dartmouth-Hitthcock Medical Center-Hanover, NH 03756-NEW JERSEY:
0055 Daniel-R. Hain, M.D., Chairperson Radioactive Drug Research Committee Newark.Beth Israel Medical Center-201 Lyons Avenue i
Newark, NJ 07112 0086 John R. Mathew, M.D., Chairperson Radioactive Drug.Research Committee Chief, Nuclear Medicine Veterans: Administration Medical Center y
East. Orange, NJ 07019
.i u
1
. J
.,--a
i rage it 0150 Elizabeth A. Alger H.D., Chairperson Radioactive Drug Research Committee Office of Education, C-662 MSB 1
UHDNJ-New Jersey Medical School j
185 South Orange Avenue Newark, NJ 07103-2757 NEW YORK:
0001 Eric J. Hall, Ph.D.,. D.Sc., Chairperson-Radioactive Drug Research Committee Columbia Presbyterian Medical Center 630 West 168th Street New York, NY 10032 0012 David R. Christman, D.Sc., Chairperson Radioactive Drug Research Comittee Chemistry Dept., Bldg. 555 Brookhaven National Laboratory Upton, NY 11973 0015 INACTIVE Robert B. Chodos, M.D., Chairperson Radioactive Drug Research Comittee Profesor of Medicine and Radiology Albany Medical Center Hospital New Scotland Avenue Albany, NY 12208 0019 INACTIVE
, Ph.D., Chairperson Radioactive Drug Research Comittee Nuclear Medicine Section V.A. Medical Center Albany, NY 1220B (terminated 1/15/79) 0025 Joseph A. Prezio, M.D., F.A.C.P., Chairperson Radioactive Drug Research Comittee Department of Nuclear Medicine State University of New York at Buffalo V.A. Medical Center-Building #5 3495 Bailey Avenue Buffalo, NY 14215
Page 17 0083 INACTIVE Halton H. Shreeve, M.D., Ph.D., Chairperson Radioactive Drug Research Comittee Nuclear Medicine _ Service (115)
V.A. Medical' Center Northport, NY 11768 0089 Robert B. Chodos, M.D., Chairperson Radioactive Drug Research Comittee Albany Medical College (HE 110) 47 New Scotland Avenue Albany, NY -12208 0101 Hanfred Blum, M.D., Chairperson.
Radioactive Drug Research Comittee c/o C.H. Marshall, Ph.D.
N.Y.U. Medical Center Radiation Safety Office, RR820 560 First Avenue New York, NY 10016 0102 INACTIVE Hary Kreek, M.D., Acting Chairperson Radioactive Drug Research Comittee The Rockefeller University Hospital 1230 York Avenue New York, NY 100'1 2
0103 Donald Margouleff, M.D., Chairperson Radioactive Drug Research Comittee Chief Nuclear Medicine Service North Shore University Hospital 300 Comunity. Drive Manhasset, NY-11030 0105 John S. Laughlin, Ph.D., Chairperson Raoloactive Drbg Reasearch Comittee Hemorial Sloan-Kettering Cancer Center 1275 York Avenue New York, NY 10021-6007 0123 Horelly L. Haayan, M.D., Chairperson Radioactive Drug Research Comittee Chief, Nuclear Medicine Service V.A. Medical Center 800 Poly Place Brooklyn, NY 11209 h
Page'13 0128 INACTIVE-
. H. Rodney Hartmann,LM.D.,-Cheirperson Radioactive Drug Research Committee Radiologist-in-Chief The Mary Imogene Bassett Hospital Cooperstown. NY 13326
~
0146 Charles S. Lieber, M.D., Chairperson Radioactive Drug Research Committee Veterans Administration Medical Center 130 West Kingsbridge Road Bronx, NY ;10468 0160 Harold L.'Atkins, M.D., Chairperson.
Radioactive Drug Research Committee Professor of Radiology Radiology Department-Health' Sciences Center, L-4.
State University of New York at Stony.8 rook.
Stony Brook, NY 11794-8460 NORTH CAROLINA:
0003 Henry Kamin, Ph.D.,LChairperson Radioactive Drug Research Committee.
Department'of Biochemistry Duke University Medical Center-t Durham, NC' 27710 0116 INACTIVE-Hilliam R. Nicolay,. M.D.,: Chairperson Radioactive Drug Research Committee Nuclear' Medicine Service (115)
-V.A. Medical' Center Fayett3ville, NC 28301 NORTH DAKOTA:
0119 Glenn I. Lykken, Ph.D., Chairperson Radioactive Drug Research Committee Professor of Physics University.of North Dakota Grand Forks', ND 58202~
5 4
T rw T-9 N-T
ras <>
0084 Suresk Kolli, M.D., Chairperson Radioactive Drug Research Committee c/o Steven H. Langraf, M.A.
Health Physicist /RSO (115H)
Veterans Administration Medical Center 10701 East Boulevard Cleveland, OH 44106 0093 Eugene L. Saenger, M.D., Chairperson Radioactive Drug Research Committee E. L. Saneger Radioisotope Laboratory ML #577 e
University Hospital Cincinnatt, OH 45267 0104 Hilliam J. Potvin, Ph.D., Chairperson Radioactive Drug Research Committee Medical College of Ohio 3800 Arliagton Avenue C.S. 10008 Toledo,'0H 43699 0147 Antonio Antunez, M.D., Chairperson Radioactive Drug Research Committee c/o P. Sridhan Rau, Ph.D.
Department of Radiology University Hospitals of Cleveland 2074 Abington Road Cleveland, OH 44106 0166 Gopal B. Saha, Ph.D., Chairperson Radioactive Drug Research Committee Department of Nuclear Medicine Cleveland Clinic Foundation 9500 Euclid Avenue Cleveland, OH 44106 OKLAHOMA:
0035 E. Hillir.m Alien. H.D., Chairperson Radioactive Drug Research Committee University of Oklahoma Health Sciences Center P.O. Box 26901 Oklahoma City, OK 73190
.i
Page 20 OREGON:
0007 G.T. Krishnamurthy, M.D., Chairperson Radioactive Drug Research Com.nittee VA Medical Center Portland Division-3710 Southwest U.S. Veterans Hospital Road P.O. Box 1034 Portland, OR 97207 PENNSYLVANIA:
0009 Laurence'Demers, Ph.D., Chairperson Radioactive Drug Research Committee Division of Health Physics The Hilton S. Hershey Hedical Center Hershey, PA 17033 0010 Karl Rickels, M.D. Chairperson Radioactive Drug Research Committee 203 Piersol Building Hospital of the University of Pennsylvania 3400 Spruce Street Philadelphia, PA 19104 0022 INACTIVE John J. Pulich, D.O., Chairperson Radioactive Drug Research Committee Lancaster Osteopathic Hospital j
1175 Clark Street Lancaster, PA 17604 0037 N. David Charkes, M.D., Chairperson Radioactive Drug Research Committee Section of Nuclear Medicine Temple University Philadelphia, PA 19140 0039 George L. Jackson, M.D., Chairperson Radioactive Drug Research Committee Harrisburg Hospital South Front Street Harrisburg, PA 17101-2099 0069 INACTIVE Robert L. Bell, M.D., Chairperson Radioactive Drug Research Committee Chief, Nuclear Medicine Service V.A. Medical Center Coatsville, PA 19320
Page 21 0070-Joe E. Smith, Pharm. D., Chairperson
~
Radioactive Drug Research Committee Thomas Jefferson University Hospital lith & Halnut Streets Philadelphia, PA 19107 0111 Richard L. Kalla, M.D., Chairperson Radioactive Drug Research Committee Montefiore Hospital 3459 Fifth Avenue Pittsburgh, PA 15213 0113 Sheldon F. Baum, M.D... Chairperson Radioactive Drug Research Committee Chief, Division of Nuclear Medicine Lankenau Hospital Lancaster Avenue west of City Line Philadelphia, PA 19151 0143 INACTIVE George A. Hermann, M.D., Chairperson Radioactive Drug Research Committee Presbyterian-University of Pennsylvania Medical Center 51 North 39th Street Philadelphia, PA 19104 0161 Robert H. Mcdonald, Jr., M.D., Chairperson Radioactive Drug Research Committee Radiation Safety Office Room A-550 Crabtree Hall Pittsburgh, PA 15261 RHODE ISLAND:
f 0034 Hilliam S. Klutz, M.D., Chairperson Radioactive Drug Research Committee Roger Hilliams General Hospital 825 Chalkstone Avenue Providence, RI 02908 0114 INACTIVE Sanford C. Spraragen, M.D., Chairperson Radioactive Drug Research Committee Chief, Nuclear Medicine Service (115)
V. A. Medical' Center Providence, RI 02909 0167 George J. Hickey, Jr.
Assistant Vice President /Research Rhode Island Hospital 593 Eddy Street Providence, Rhode Island 02092 i
i
-~m e
Page 22 SOUTH CAROLINA:
0077 INACTIVE Hakio Ogawa, H.D., Chairperson Radioactive Drug Research Committee Research Service V.A. Medical Center 109 Bee Street Charleston, SC 29403 0153 INACTIVE Nicholas Detorie, Ph.D., Chairperson Radioactive Drug Research Committee Hm. Jennings Bryan Dorn Veterans' Hospital Columbia, SC 29201 SOUTH DAKOTA:
0106 INACTIVE J. Michael McH1111n, M.D., Chairperson Radioactive Drug Research Committee Veterans Administration Center.
2501 West 22nd Street Sioux Falls, SD 57101 11NNESSEE1 0013 S. Julian Gibbs, D.D.S., Ph.D., Chairperson Radioactive Drug Research Committee Vanderbilt University-Hedical Center DD 1207 Medical Center North Nashville, TN 37232 0094 Raymond L. Tanner, Ph.D, Chairperson Radioactive Drug Research Committee University of Tennessee, Hemphis 800 Madison Avenue Hemphis, TN 38163
Page 23
~
TEXAS:
0021 Thomas P. Haynie, M.D., Chairperson Radioactive Drug Research Committee Department of Nuclear Medicine The University of Texas System Cancer Center H.D. Anderson Hospital and Tumor Institute 1515 Holccmbe Boulevard Houston, TX 77030 0044 INACTIVE Robert H. Parkey, M.D., Chairperson Radioactive Drug Research Committee University of Texas Southwestern Medical School 5323 Harry Hines Boulevard Dallas, TX 75235 0046 Paul H. Heigel, Ph.D., Chairperson Radioactive Drug Research Committee Human Biological Chemistry and Genetics (F-45)
University of Texas Medical Branch Galveston, TX 77550 0051 Satish G. Jhingran, M.D., Chairperson Radioactive Drug Research Committee The Methodist Hospital 6565 Fannin M.S. A10004 Houston, TX 77030 0056 Tuhin K. Chaudhuri. H.D., Chairperson Radioactive Drug Research Committee Division of Nuclear Medicine The University of Texas Health Science Center At San Antonio 7703 Floyd Curi Drive San Antonio, TX 78284 0061 Tuhin K. Chaudhuri, M.D., Chairperson Radioactive Drug Research Committee Chief, Nuclear Medicine Service (115)
Audie Murphy V.A. Hospital 7400 Merton Minter Blvd.
San Antonio, TX 78284 i
Page 24 0075 INACTIVE Thomas C. Smitherman, M.D., Chairperson Radioactive Drug Research Committee Veterans Administration Medical Center 4500 South Lancaster Road Dallas, TX 75216 0081 Haurice Crass, Ph.D., Chairperson Radioactive Drug Research Committee Department of Physiology Texas Tech University Health Sciences Center.
3601 4th St.
Lubbock, TX 79430 0124 INACTIVE Phillip C. Johnson, Jr., M.D.
Acting Chairperson Radioactive Drug Research Committee NASA-Johnson Space Center Hail Code SD Houston, TX 77058 0144 Roger Barber, Ph.D., Cheirperson Radioactive Drug Research Committee The University of Texas Health Science Center at Houston Graduate School of Biomedical Sciences P.O. Box 20334 Astrodome Station Houston, TX 77225 UTAH:
0078 Dennis leavitt, Ph.D., Chairperson Radioactive Drug Research Committee Radiation Therapy University of Utah Hedical Center Salt Lake City, UT 84132 VERHONT:
0026 John P. Clements, M.D., Chairperson Radioactive Drug Research Committee Nuclear Medicine Department Medical Center Hospital of Vermont Burlington, VT 05401
Page 25 VIRGINIA:
0011 Charles D. Teates, M.D., Chairperson Radioactive Drug Research Committee Professor and Director Division of Medical Imaging University of Virginia Medical Center Charlottesville, VA 22908 0058 George P. Vennart, M.D., Chairperson Radioactive Drug Research Committee Pathology Department (Chairman)
Sanger Hall, Room 4-011 Box 662 HCV Station Richmond, VA '23298 0090 INACTIVE Kenneth N. Scott, M.D., CAPT, MC, Chairperson Radioactive Drug Research Committee Chief, Radiology Service Naval Regional Medical Center Portsmouth, VA 23708 0127 INACTIVE Hilliam Kramer, M.D., Chairperson Radioactive Drug Research Committee St. Mary's Hospital 5801 Bremo Road Richmond, VA 23226 WASHINGTON STATE:
000S INACTIVE Raymond Marty H.D., Chairperson (1980)
Radioactive Drug Research Committee Tumor Institute of the Swedish Hospital.
1211 Marion Street Seattle, HA 98104 e
!L Page 26 0121 Anthony F. Shields, M.D..-Ph.D.,. Chairperson.
Radioactive Drug Research Committee V.A. Medical Center (111) 1660 South Columbian May Seattle, HA 98108 HISCONSIN:
I 0052 B. David. Collier, M.D., Chairperson Radioactive Drug Research Committee
' Milwaukee County Medical.' Complex.
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.8700 H. Hisconsin Avenue Milwaukee, HI53226
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1 0065 Arnold J. Krubsack M.D., Ph.D., Chairperson Radioactive Drug Research Committee Acting Chief Nuclear Medicine Service Clement J. Zablocki V.A.. Medical Center Milwaukee, HI 53295 0091 Archie A. MacKinney, Jr...M.D..'ChairpersonL i
Radioactive Drug Research Committee J
Chief, Hematology-Section.(607/111)
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Hm. S. tilddleton Memorial Veterans Hospital 1
2500 Overlook Terrace-J Madison, HI 53705 H
0100 INACTIVE Frank C. Larson, M.D., Chairperson-Radioactive Drug Research Committee-Clinical Science Center University of Wisconsin Medical School 600 Highland Ave Madison, HI 53792 HEST VIRGINIA:
0142 INACTIVE Stephen T. Slack, Ph.D.
Radioactive Drug Research Committee Radiation Safety Officer Division of Medical Physics and Radiation Safety West Virginia University Medini Center Morgantown, WV 26506 Neely/ Farkas Hang 1969B 7/27/88 l
Letters to the Editor s
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FDA Letter to Radioactive and subject to the requirements of 312.1,' 4.e., require an Drug Research Chairpersons IND, (federal Register. Monday, July 2o. '974). Although the distinction is clearly stated, tLere can te areas of overlap
- TO TiiE EDITOR: The following letter was sent to chairper-between "research" and "c!mical trial" studies. It is recog-sons of the Radioactive Drug Research Committees in an nized, for example. that the earliest stadies showing localiza-effort by the Food and Drug Administration (FDA) to answer tion of a drug in a particular organ or !!uid space will have certain questions that are frequently asked regarding the obvious relevance to the later trials; nor:etheless, these early requirements of a study that may be performed under 21 CFR localization studies are considered basic research. We have, 361.1 " Prescription Drugs for Human Use Generally Recog-however, reviewed RDRC spproved protocols in which the f
nized as Safe and Effective and not Misbranded: Drugs Used evaluation of the drug as a clinical tool for particular organs i
in Research." I believe your readers may be interested in it.
or spaces was clearly the research objective. While, the dis.
C Since the initiation of research with radioactive drugs in tinction is not always c!careut.where doubt exists as to wheth-i 1975 under 21 C FR 361.1, we have observed with satisfaction er the research proposal is basic research, as defined % &
the acceptance and growth of the concept within the nuclear regulation, the drug should be considered a ne crug for a
d medicine community. Inevitably, as decisions by your com-which an IND is required.
mittees have been made under the provisions of 21 CFR 361.1 The limitation on radiation dose is clearly stated and wmc and reviewed by FDA staff, some questions have arisen as to have felt that these limits mean that the FDA has determined M
what the regulations would permit. In particular, there has these radiation doses to be safe. The FDA does not feel that been a tendency to try to utilize 361.1 to carry out early any dose of radiation is absolutely safe, or that higher doses clinical trials of a radiopharmaceutical drug that properly are than those proposed are necessarily unsafe.There was a need conducted under an IND. We would like to provide our views for the purposes of this regulation to ficd some reasceable h
on these questions.
level below which the radiation doses would present minimal a
Part 361.1 designates certain research uses of radioactive risk. Based on the radiation dose limitations established by N
drugs as " generally recognized as safe and effective." When a NRC for basic occupational radiation protection (10 CFR h
drug is generally recognized as safe and effective it is not a 20.101 and 20.102), we proposed these as levels below which a "new drug " as defined by the Food. Drug. and Cosmetic Act drug could be considered as not a new drug, so long as all other
- hich states that a "new drug"is one "not generally recog-portions of the regulations were met.
-l9 nized... as safe and effective for use under the conditions Although methodology is specified in th regulation by b
r. scribed, recommended, or suggested in the labeling.." which radiation dose estimates are to be derive d and reported,
)
When a "new drug"is used in humans and the drug is not yet with special attention to whole body, active blood forming a pproved for ma rketing. a n lND is required. No IND, howev-organs, lens of the eye, and gonads, taking into account the er, is needed to study a drug that is not a new drug. The contribution of radiocontaminants and other radiation expo-h RDRC cannot provide an exemption from the act for new sure procedures associatt.d with the study, the reporting has f.
drugs, but ca n determine, under the specific requirements set frequently been incomplete. The total calculated radiation forth in 361.1 that the drug to be used is, under the conditions dose exposure per study must include all aspects of exposure
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specified by the investigator's protocol and approved by the including x ray examinations and other isotope procedures
,l committee. not a new drug..
related to the study. This should also include the radiation I5 The provisions of the RDRC regulations specifying how a dose from possible radiocontaminants. The method of calcu.
committee can determine that a drug is " generally recognized lating the radiation exposure should be one that estimates a i
as safe and effective" and, therefore, not a new drug, are " worst case" situation as we would like to have adequate 2;.
detailed in 361.1.1.41 me address these briefly.
evidence that the radiation dose levels will not be exceeded.
The type of research tha t may be undertaken with the drug With radiopharmaceuticals in early investigation, adequate must be intended to obtain basic information and not to carry biodistribution data may not be available or may be equivocal r
out a clinical trial. The types of basic research permitted are so that the committee may not be able to establish that the specified in the regulation, and include studies of meta bolism, radiation dose limits will not exceed the levels set by the r9 human physiology, pathophysiology, or biochemistry. Types regulation. Availa ble methodology may also leave uncertain-of research studies not permitted under this regulation are ty as to whether radiation dose to the critical organs will be also speified. and include those " intended for (the) immedi-within the specified limits. Where the committee cannot be ate therapeutic, diagnostic or similar purposes, or to deter-certain that the radiation dosage criteria will be met, an M mine the safety and effectiveness of the drug in humans for should be sought.
such purposes (i.e., to carry out a clinical trial) " The notice of Similar reasoning extends to the limitations on pharmaco-proposed rule making for this regulation stated "the evalua-logie dose which "shsil be known not to cause any clinically tion of the drug as a clinical tool, including comparison with detectable pharmacologic effect in human beings." For the other agents. should be considered as part of a clinical tnal committee to conclude that this criterion has been satisfied.
Volume 26 + Number 7
- Jufy 1985 I
.mMN S'WP d_,
there must be pharmacologic data avadable from studies in scinuarapny in 1965 (2) and is s!so interested in salivary ghrai" Auman subpets that *ould form the basis of the committee's alterations m the follow-up of thyroid-carcinoma. In 1980 we action if no data are avadable, esen the smallest amount of conducted a prospective quantitative study using dinamic l
the drug must be assumed to produce pharmacologic activity. salivary g!and scintigraphy to evaluate radiation risk of io.
and an IND should be sought, dine.131 (13'I) therapy (3), as proposed by Dr. Allweis.
Once approved. the study should be the subject of continu.
We examined 20 thyroid carcinoma patients (16 female,4 ing review at the committee's quarterly meetings so that it male; age range 25 to 82 yr) three times each, applying 2 mci I
does not evolve into a research project that no lor:ger satisfies technetium.99m pertechnetste and analyzing time. activity the enteria for RDRC approval. Reports of the progress of curves from regions of interest over parotids and subman ti-approved studies are made to us yearly, but there is a require-bular glands (before '311 therapy, after cumulative doses of 170 ment for immediate reporting if the study tm olves exposure of mci and 270 mci 83'l). All tests ran under full thyroid hor-more than 30 research subjects or of any research subject mone substitution. Salivary secretion was quantified by per-
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under 18 yr of age.This requirement has not been complied technetate uptake before and after stimulation (2 ml plain with in some cases, and we consider it important to our lemon-juice by mouth).
overview responsibdity.
Our data demonstrated a dose-dependent reduction of sal.
i There are several other issues that have been the source of ivary gland function due to high dosage 33'l therapy. Parotid d
some confusion in the past:
alterations were more frequent and more distinct than sub-I
- 1. The RDRC. as defined in 21 CFR 361.1 has no over-mandibular gland lesions.
sight responsibility or authority over an investigation carried For parotid glands, pertechnetate uptake after 270 mci 8311 out under an IND exemption. This authority is retained by is reduced on an average of 40% compared to 30% for sub-the FDA. Title 21 CFR 361.1 however, does not in any way mandibular glands (4).
prohibit an institution from involving the RDRC in other A general survey of our 381-treated thyroid carcinoma pa.
policy matters, including the use of radioactive drugs,ifit se tients showed alterations of at least one salivary gland in about chooses.
30% (5). According to our data,in some cases complete loss
- 2. The RDRC is distinct from all other investigational of salivary gland secretion threatens after a cumulative dose I
drug review committees witHn an institution such as the of 500 mci t3'I.
radiation safety committee and the Institutional Review in conclusion, we agree with Dr. Allweis that actual salivary Board (IRB). The approval of bth of these committees in gland function should be taken into consideration planning 3311 addition to RDRC approval, is required before an RDRC therapy for thyroid carcinoma. Patients undergoing radiciodine investigation can be permitted to start.
treatment shculd consequently stimulate salivation during the
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- 3. The RDRC is estaolished and chartered by the FDA days following 8381 application. We feel that this, besides suf-under 21 CFR 361.1. It is not related to any specific type of ficient fluid intake, is one of the quite rare medical indications license granted by the NRC or State. Regulatory bodies-for lemon candtes and chewing gum.
These licensing authorities, of course, make their own regula-tions. rules. and requirements. For their own purposes, they REFERENCES may make an RDRC a requirement for a specific type of license, but these are not requirements under 21 CFR 361.1.
1.
Allweis P. Braunstein GD, Katz A, et at: Sialadenitis in sharing these observations with you. I also invite your following 1 131 therapy for thyroid carcinoma: Concise comments. My intent is to preserve and improve the imple-communication. J Nuc/ Med 25: 755-758,1984 rnentation of the RDRC regulations.
2.
B6tner W. Gr0nberg H. Moll E: Die szintigraphische Questions and comments should be directed to Mr. Neil darstellung der kopfspeicheldrssen mit technetium-99m.
j Med Welt 2378-2380,1965 i
Abel, a Reviewing Pharmacist and the Executive Secretary of 3.
Reiners C, Eilles C.,Eichner R, et at: Spe,cheldr0sen-j i
the Radiopharmaceutical Drugs Advisory Committee to the I""
' ****""I'*E FDA. His address is the Division of Oncology and Radiophar-therapie des schilddrasen karzinoms mit radiojod. Auk.
maceutial Drug Pr&lucts/ Office of Drug Research and Icarmedi iner 3: 281-286,1980 Review (HFN 150), Food and Drug Administration, Center 4.
Reiner C. Eichner R, Eilles C, et at: Kamera funk-fot Drugs and Biologics,5600 Fishers tane, Rockville, Mary-tionsszintigraphic der kopfspeicheldr0sen nach hoch-land 20857.
dosierter radiojodtherapie bei schilddrosenkarzinom-patienten. In Nuk/carmedizin,Schmidt HAE Riccabona Robert Temple G, eds. Stuttgart, New York, Schattauer, 477-481 Office ofDrug Research and Review
}9go Centerfor Drugs and Biologics 5.
Reiners C, Barner W. Eilles C, et al: Functional scintig-Rockville. Maryland raphy of the human salivary glands. IAESSW 247:
152-153,1980 j
W. Spiegel Sialadenitis Following Iodine-131 Therapy for Chr. Reiners Thyroid Carcinoma W. B6rner Abt.f. Nuklearmedizin TO THE EDITOR: Allweis et al. (1) recently demonstrated der Unit'ersildt ten cues of radiation sialadenitis following *ac'iciodine therapy Josef-Schneider-Strasst 2 for tbyroid carcinoma. Our team inaugurated salivary gland WGr: burg, FRG 816 Letters to the Editor 3.2 The Journal of Nuclear Medicine
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retofore made by the bcensee, a license is hereby issued authonzing the licensee to receive. acquire, possess, and transfer g
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